Title 21 Food and Drugs Parts 500 to 599

Home , Caramiphen, Carnidazole, Chlorphenesin carbamate

Revised as of April 1, 2018

Containing a codification of documents of general applicability and future effect

As of April 1, 2018

Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register

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Legal Status and Use of Seals and Logos The seal of the National Archives and Records Administration (NARA) authenticates the Code of Federal Regulations (CFR) as the official codification of Federal regulations established under the Federal Register Act. Under the provisions of 44 U.S.C. 1507, the contents of the CFR, a special edition of the Federal Register, shall be judicially noticed. The CFR is prima facie evidence of the original documents published in the Federal Register (44 U.S.C. 1510). It is prohibited to use NARA’s official seal and the stylized Code of Federal Regulations logo on any republication of this material without the express, written permission of the Archivist of the United States or the Archivist’s designee. Any person using NARA’s official seals and logos in a manner inconsistent with the provisions of 36 CFR part 1200 is subject to the penalties specified in 18 U.S.C. 506, 701, and 1017.

Use of ISBN Prefix This is the Official U.S. Government edition of this publication and is herein identified to certify its authenticity. Use of the 0–16 ISBN prefix is for U.S. Government Publishing Office Official Edi- tions only. The Superintendent of Documents of the U.S. Govern- ment Publishing Office requests that any reprinted edition clearly be labeled as a copy of the authentic work with a new ISBN.

U.S. GOVERNMENT PUBLISHING OFFICE U.S. Superintendent of Documents • Washington, DC 20402–0001 http://bookstore.gpo.gov Phone: toll-free (866) 512-1800; DC area (202) 512-1800

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Page Explanation ...... v

Title 21:

Chapter I—Food and Drug Administration, Department of Health and Human Services (Continued) ...... 3

Finding Aids:

Table of CFR Titles and Chapters ...... 597

Alphabetical List of Agencies Appearing in the CFR ...... 617

List of CFR Sections Affected ...... 627

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To cite the regulations in this volume use title, part and section number. Thus, 21 CFR 500.23 refers to title 21, part 500, section 23.

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The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further sub- divided into parts covering specific regulatory areas. Each volume of the Code is revised at least once each calendar year and issued on a quarterly basis approximately as follows: Title 1 through Title 16...... as of January 1 Title 17 through Title 27 ...... as of April 1 Title 28 through Title 41 ...... as of July 1 Title 42 through Title 50...... as of October 1 The appropriate revision date is printed on the cover of each volume. LEGAL STATUS The contents of the Federal Register are required to be judicially noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie evidence of the text of the original documents (44 U.S.C. 1510). HOW TO USE THE CODE OF FEDERAL REGULATIONS The Code of Federal Regulations is kept up to date by the individual issues of the Federal Register. These two publications must be used together to determine the latest version of any given rule. To determine whether a Code volume has been amended since its revision date (in this case, April 1, 2018), consult the ‘‘List of CFR Sections Affected (LSA),’’ which is issued monthly, and the ‘‘Cumulative List of Parts Affected,’’ which appears in the Reader Aids section of the daily Federal Register. These two lists will identify the Federal Register page number of the latest amendment of any given rule. EFFECTIVE AND EXPIRATION DATES Each volume of the Code contains amendments published in the Federal Reg- ister since the last revision of that volume of the Code. Source citations for the regulations are referred to by volume number and page number of the Federal Register and date of publication. Publication dates and effective dates are usually not the same and care must be exercised by the user in determining the actual effective date. In instances where the effective date is beyond the cut- off date for the Code a note has been inserted to reflect the future effective date. In those instances where a regulation published in the Federal Register states a date certain for expiration, an appropriate note will be inserted following the text. OMB CONTROL NUMBERS The Paperwork Reduction Act of 1980 (Pub. L. 96–511) requires Federal agencies to display an OMB control number with their information collection request.

VerDate Sep<11>2014 18:00 Apr 30, 2018 Jkt 244075 PO 00000 Frm 00005 Fmt 8008 Sfmt 8092 Q:\21\ARCHIVE\21V6.TXT 31 kpayne on DSK54DXVN1OFR with $$_JOB Many agencies have begun publishing numerous OMB control numbers as amendments to existing regulations in the CFR. These OMB numbers are placed as close as possible to the applicable recordkeeping or reporting requirements. PAST PROVISIONS OF THE CODE Provisions of the Code that are no longer in force and effect as of the revision date stated on the cover of each volume are not carried. Code users may find the text of provisions in effect on any given date in the past by using the appropriate List of CFR Sections Affected (LSA). For the convenience of the reader, a ‘‘List of CFR Sections Affected’’ is published at the end of each CFR volume. For changes to the Code prior to the LSA listings at the end of the volume, consult previous annual editions of the LSA. For changes to the Code prior to 2001, consult the List of CFR Sections Affected compilations, published for 1949- 1963, 1964-1972, 1973-1985, and 1986-2000. ‘‘[RESERVED]’’ TERMINOLOGY The term ‘‘[Reserved]’’ is used as a place holder within the Code of Federal Regulations. An agency may add regulatory information at a ‘‘[Reserved]’’ location at any time. Occasionally ‘‘[Reserved]’’ is used editorially to indicate that a portion of the CFR was left vacant and not accidentally dropped due to a printing or computer error. INCORPORATION BY REFERENCE What is incorporation by reference? Incorporation by reference was established by statute and allows Federal agencies to meet the requirement to publish regulations in the Federal Register by referring to materials already published elsewhere. For an incorporation to be valid, the Director of the Federal Register must approve it. The legal effect of incorporation by reference is that the material is treated as if it were published in full in the Federal Register (5 U.S.C. 552(a)). This material, like any other properly issued regulation, has the force of law. What is a proper incorporation by reference? The Director of the Federal Register will approve an incorporation by reference only when the requirements of 1 CFR part 51 are met. Some of the elements on which approval is based are: (a) The incorporation will substantially reduce the volume of material published in the Federal Register. (b) The matter incorporated is in fact available to the extent necessary to afford fairness and uniformity in the administrative process. (c) The incorporating document is drafted and submitted for publication in accordance with 1 CFR part 51. What if the material incorporated by reference cannot be found? If you have any problem locating or obtaining a copy of material listed as an approved incorporation by reference, please contact the agency that issued the regulation containing that incorporation. If, after contacting the agency, you find the material is not available, please notify the Director of the Federal Register, National Archives and Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001, or call 202-741-6010. CFR INDEXES AND TABULAR GUIDES A subject index to the Code of Federal Regulations is contained in a separate volume, revised annually as of January 1, entitled CFR INDEX AND FINDING AIDS. This volume contains the Parallel Table of Authorities and Rules. A list of CFR titles, chapters, subchapters, and parts and an alphabetical list of agencies publishing in the CFR are also included in this volume.

VerDate Sep<11>2014 18:00 Apr 30, 2018 Jkt 244075 PO 00000 Frm 00006 Fmt 8008 Sfmt 8092 Q:\21\ARCHIVE\21V6.TXT 31 kpayne on DSK54DXVN1OFR with $$_JOB An index to the text of ‘‘Title 3—The President’’ is carried within that volume. The Federal Register Index is issued monthly in cumulative form. This index is based on a consolidation of the ‘‘Contents’’ entries in the daily Federal Reg- ister. A List of CFR Sections Affected (LSA) is published monthly, keyed to the revision dates of the 50 CFR titles. REPUBLICATION OF MATERIAL There are no restrictions on the republication of material appearing in the Code of Federal Regulations. INQUIRIES For a legal interpretation or explanation of any regulation in this volume, contact the issuing agency. The issuing agency’s name appears at the top of odd-numbered pages. For inquiries concerning CFR reference assistance, call 202–741–6000 or write to the Director, Office of the Federal Register, National Archives and Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001 or e-mail [email protected]. SALES The Government Publishing Office (GPO) processes all sales and distribution of the CFR. For payment by credit card, call toll-free, 866-512-1800, or DC area, 202-512-1800, M-F 8 a.m. to 4 p.m. e.s.t. or fax your order to 202-512-2104, 24 hours a day. For payment by check, write to: US Government Publishing Office – New Orders, P.O. Box 979050, St. Louis, MO 63197-9000. ELECTRONIC SERVICES The full text of the Code of Federal Regulations, the LSA (List of CFR Sections Affected), The United States Government Manual, the Federal Register, Public Laws, Public Papers of the Presidents of the United States, Compilation of Presi- dential Documents and the Privacy Act Compilation are available in electronic format via www.ofr.gov. For more information, contact the GPO Customer Con- tact Center, U.S. Government Publishing Office. Phone 202-512-1800, or 866-512- 1800 (toll-free). E-mail, [email protected]. The Office of the Federal Register also offers a free service on the National Archives and Records Administration’s (NARA) World Wide Web site for public law numbers, Federal Register finding aids, and related information. Connect to NARA’s web site at www.archives.gov/federal-register. The e-CFR is a regularly updated, unofficial editorial compilation of CFR material and Federal Register amendments, produced by the Office of the Federal Register and the Government Publishing Office. It is available at www.ecfr.gov.

OLIVER A. POTTS, Director, Office of the Federal Register. April 1, 2018.

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Title 21—FOOD AND DRUGS is composed of nine volumes. The parts in these volumes are arranged in the following order: Parts 1–99, 100–169, 170–199, 200–299, 300–499, 500–599, 600–799, 800–1299 and 1300 to end. The first eight volumes, containing parts 1–1299, comprise Chapter I—Food and Drug Administration, Depart- ment of Health and Human Services. The ninth volume, containing part 1300 to end, includes Chapter II—Drug Enforcement Administration, Department of Jus- tice, and Chapter III—Office of National Drug Control Policy. The contents of these volumes represent all current regulations codified under this title of the CFR as of April 1, 2018.

For this volume, Ann Worley was Chief Editor. The Code of Federal Regula- tions publication program is under the direction of John Hyrum Martinez, as- sisted by Stephen J. Frattini.

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(This book contains parts 500 to 599)

Part

CHAPTER I—Food and Drug Administration, Department of Health and Human Services (Continued) ...... 500

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EDITORIAL NOTE: Nomenclature changes to chapter I appear at 69 FR 13717, Mar. 24, 2004, and 69 FR 18803, Apr. 9, 2004.

SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

Part Page 500 General ...... 5 501 Animal food labeling ...... 15 502 Common or usual names for nonstandardized animal foods ...... 32 507 Current good manufacturing practice, hazard analysis, and risk–based preventive controls for food for animals ...... 34 509 Unavoidable contaminants in animal food and food-packaging material ...... 68 510 New animal drugs ...... 72 511 New animal drugs for investigational use ...... 82 514 New animal drug applications ...... 87 515 Medicated feed mill license ...... 124 516 New animal drugs for minor use and minor species 128 520 Oral dosage form new animal drugs ...... 153 522 Implantation or injectable dosage form new animal drugs ...... 268 524 Ophthalmic and topical dosage form new animal drugs ...... 350 526 Intramammary dosage form new animal drugs ...... 376 528 New animal drugs in genetically engineered animals ...... 382 529 Certain other dosage form new animal drugs ...... 383 530 Extralabel drug use in animals ...... 389 556 Tolerances for residues of new animal drugs in food 396 558 New animal drugs for use in animal feeds ...... 410 564 [Reserved] 570 Food additives...... 520 571 Food additive petitions ...... 532 3

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Part Page 573 Food additives permitted in feed and drinking water of animals ...... 537 579 Irradiation in the production, processing, and handling of animal feed and pet food ...... 561 582 Substances generally recognized as safe ...... 562 584 Food substances affirmed as generally recognized as safe in feed and drinking water of animals ...... 586 589 Substances prohibited from use in animal food or feed ...... 587 590–599 [Reserved]

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PART 500—GENERAL 500.92 Implementation. Subpart F—Methods for Detection of Resi- Subpart A [Reserved] dues of Carcinogenic Compounds Subpart B—Specific Administrative Rulings Used in Food-Producing Animals and Decisions 500.1410 N-methyl-2-pyrrolidone.

Sec. AUTHORITY: 21 U.S.C. 321, 331, 342, 343, 348, 500.23 Thermally processed low-acid foods 351, 352, 353, 360b, 371, 379e. packaged in hermetically sealed con- SOURCE: 40 FR 13802, Mar. 27, 1975, unless tainers. otherwise noted. 500.24 Emergency permit control. 500.25 Anthelmintic drugs for use in animals. Subpart A [Reserved] 500.26 Timed-release dosage form drugs. 500.27 Methylene blue-containing drugs for Subpart B—Specific Administrative use in animals. Rulings and Decisions 500.29 Gentian violet for use in animal feed. 500.30 Gentian violet for animal drug use. § 500.23 Thermally processed low-acid 500.45 Use of polychlorinated biphenyls foods packaged in hermetically (PCB’s) in the production, handling, and sealed containers. storage of animal feed. 500.46 Hexachlorophene in animal drugs. Except as provided in § 507.5(b) of this 500.50 Propylene glycol in or on cat food. chapter, the provisions of parts 507 and 113 of this chapter apply to the manu- Subpart C—Animal Drug Labeling facturing, processing, or packing of Requirements low-acid foods in hermetically sealed containers, and intended for use as food 500.51 Labeling of animal drugs; mis- for animals. branding. 500.52 Use of terms such as ‘‘tonic’’, ‘‘tone’’, [80 FR 56337, Sept. 17, 2015] ‘‘toner’’, or ‘‘conditioner’’ in the labeling of preparations intended for use in or on § 500.24 Emergency permit control. animals. The provisions of part 108 of this 500.55 Exemption from certain drug-labeling chapter shall apply to the issuance of requirements. emergency control permits for the manufacturer or packer of thermally Subpart D—Requirements for Specific processed low-acid foods packaged in Animal Drugs hermetically sealed containers, and in- 500.65 Epinephrine injection 1:1,000 in 10- tended for use as food for animals. milliliter containers for emergency [61 FR 37681, July 19, 1996] treatment of anaphylactoid shock in cattle, horses, sheep, and swine. § 500.25 Anthelmintic drugs for use in animals. Subpart E—Regulation of Carcinogenic Compounds Used in Food-Producing (a) The Commissioner of Food and Animals Drugs has determined that, in order to assure that anthelmintic drugs, includ- 500.80 Scope of this subpart. ing animal feeds bearing or containing 500.82 Definitions. such drugs, which do not carry the pre- 500.84 Conditions for approval of the spon- scription statement are labeled to pro- sored compound. vide adequate directions for their effec- 500.86 Marker residue and target tissue. tive use, labeling of these anthelmintic 500.88 Regulatory method. drugs shall bear, in addition to other 500.90 Waiver of requirements. required information, a statement that a veterinarian should be consulted for

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assistance in the diagnosis, treatment, mal drug application, or listed in the and control of parasitism. index, as required by paragraph (a) of (b) The label and any labeling fur- this section. nishing or purporting to furnish direc- (c) The fact that the labeling of this tions for use, shall bear conspicuously kind of drug may claim delayed, pro- the following statement: ‘‘Consult your longed, controlled, or sustained-release veterinarian for assistance in the diag- of all or only some of the active ingre- nosis, treatment, and control of para- dients does not affect the new animal sitism.’’ drug status of such articles. A new ani- (c) For drugs covered by approved mal drug application or index listing is new animal drug applications, the la- required in any such case. beling revisions required for compli- (d) New animal drug applications for ance with this section may be placed timed-release dosage form animal into effect without prior approval, as drugs must contain, among other provided for in § 514.8(c)(3) of this chap- things, data to demonstrate safety and ter. For drugs listed in the index, the effectiveness by establishing that the labeling revisions required for compli- article is manufactured using proce- ance with this section may be placed dures and controls to ensure release of into effect without prior granting of a the total dosage at a safe and effective request for a modification, as provided rate. Data submitted in the new animal for in § 516.161(b)(1) of this chapter. drug application must demonstrate (d) Labeling revisions required for that the formulation of the drug and compliance with this section shall be the procedures used in its manufacture placed into effect by February 25, 1975, will ensure release of the active ingre- following which, any such drugs that dient(s) of the drug at a safe and effec- are introduced into interstate com- tive rate and that these release charac- merce and not in compliance with this teristics will be maintained until the section will be subject to regulatory expiration date of the drug. When the proceedings. drug is intended for use in food-pro- [40 FR 13802, Mar. 27, 1975, as amended at 71 ducing animals, data submitted must FR 74782, Dec. 13, 2006; 72 FR 69120, Dec. 6, also demonstrate that, with respect to 2007] possible residues of the drug, food derived from treated animals is safe for § 500.26 Timed-release dosage form drugs. consumption. (a) Drugs are being offered in dosage [42 FR 8635, Feb. 11, 1977, as amended at 60 forms that are designed to release the FR 38480, July 27, 1995; 72 FR 69120, Dec. 6, active ingredients over a prolonged pe- 2007] riod of time. There is a possibility of § 500.27 Methylene blue-containing unsafe overdosage or ineffective dosage drugs for use in animals. if such products are improperly made and the active ingredients are released (a) New information requires a re- at one time, over too short or too long evaluation of the status of drugs con- a period of time, or not released at all. taining methylene blue Drugs marketed in this form, which are (tetramethylthionine chloride) for oral referred to by such terms as timed-re- use in cats or dogs. lease, controlled-release, prolonged-re- (1)(i) It has been demonstrated that lease, sustained-release, or delayed-re- two orally administered urinary anti- lease drugs, are regarded as new animal septic-antispasmodic preparations that drugs within the meaning of section contained methylene blue cause Heinz 201(v) of the Federal Food, Drug, and body hemolytic anemia in cats when Cosmetic Act. used according to label directions. The (b) Timed-release dosage form animal specific cause of the reaction was de- drugs that are introduced into inter- termined to be the methylene blue con- state commerce are deemed to be adul- tained in the preparations. The reac- terated within the meaning of section tion can be severe enough to cause 501(a)(5) of the act and subject to regu- death of treated animals. latory action, unless such animal drug (ii) The Heinz body hemolytic anemia is the subject of an approved new ani- reaction to methylene blue has also

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been demonstrated in dogs under lab- section 512 of the act shall be sub- oratory conditions. The precise mecha- mitted to the Food and Drug Adminis- nism by which methylene blue pro- tration. Center for Veterinary Medi- duces the characteristic erythrocytic cine, Office of New Animal Drug Eval- inclusion bodies (Heinz bodies) and as- uation (HFV-100), 7500 Standish Pl., sociated hemolytic anemia is unclear. Rockville, MD 20855. (2) The effectiveness of orally admin- [43 FR 9803, Mar. 10, 1978; 43 FR 12310, Mar. 24, istered methylene blue as a urinary an- 1978, as amended at 54 FR 18279, Apr. 28, 1989; tiseptic is open to question. It appears 57 FR 6475, Feb. 25, 1992; 60 FR 38480, July 27, that following oral administration, 1995] methylene blue is poorly and errati- cally absorbed and also slowly and er- § 500.29 Gentian violet for use in ani- ratically excreted in the urine. Studies mal feed. in the dog indicate it is excreted in the The Food and Drug Administration urine essentially as leukomethylene has determined that gentian violet is blue stabilized in some manner. Meth- not generally recognized as safe for use ylene blue itself is stepwise in animal feed and is a food additive demethylated in alkaline solutions (al- subject to section 409 of the Federal kaline urine being a frequent con- Food, Drug, and Cosmetic Act (the sequence of urinary infection) to Azure act), unless it is intended for use as a B, Azure A, and Azure C. The antiseptic new animal drug, in which case it is efficacy of all of these excretion prod- subject to section 512 of the act. The ucts is unsubstantiated. Food and Drug Administration has de- (3) In view of the foregoing, the Com- termined that gentian violet is not missioner has concluded that animal prior sanctioned for any use in animal drugs containing methylene blue for feed. oral use in cats or dogs are neither safe nor generally recognized as effective [56 FR 40506, Aug. 15, 1991] within the meaning of section 201(v) of § 500.30 Gentian violet for animal drug the act and are therefore considered use. new animal drugs. Accordingly, all prior formal and informal opinions ex- The Food and Drug Administration pressed by the Food and Drug Adminis- (FDA) has determined that gentian vio- tration that such drugs are ‘‘not new let is not generally recognized as safe drugs’’ or ‘‘no longer new drugs’’ are and effective for any veterinary drug hereby revoked. use in food animals and is a new ani- (b) Animal drugs that contain meth- mal drug subject to section 512 of the ylene blue for oral use in cats or dogs Federal Food, Drug, and Cosmetic Act. and not the subject of an approved new FDA has determined that gentian vio- animal drug application (NADA) are let is not exempted from new animal deemed to be adulterated under the drug status under the ‘‘grandfather’’ provisions of section 501(a) (5) and/or (6) provisions of the Drug Amendments of and/or misbranded under section 502(a) 1962 (21 U.S.C. 342). of the act and subject to regulatory ac- [56 FR 40507, Aug. 15, 1991] tion as of April 10, 1978. (c) Sponsors of animal drugs that § 500.45 Use of polychlorinated contain methylene blue for oral use in biphenyls (PCB’s) in the produc- cats or dogs and not the subject of an tion, handling, and storage of ani- approved new animal drug application mal feed. (NADA) may submit an application in (a) Polychlorinated biphenyls (PCB’s) conformity with § 514.1 of this chapter. represent a class of toxic industrial Such applications will be processed in chemicals manufactured and sold under accordance with section 512 of the act. a variety of trade names, including: Submission of an NADA will not con- Aroclor (United States); Phenoclor stitute grounds for continued mar- (France); Colphen (Germany); and keting of this drug substance until Kanaclor (Japan). PCB’s are highly sta- such application is approved. ble, heat resistant, and nonflammable (d) New animal drug applications re- chemicals. Industrial uses of PCB’s in- quired by this regulation pursuant to clude, or did include in the past, their

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use as electrical transformer and ca- (3) On or before Sept. 4, 1973, the pacitor fluids, heat transfer fluids, hy- management of establishments pro- draulic fluids, plasticizers, and in for- ducing animal feed shall: mulations of lubricants, coatings, and (i) Have the heat exchange fluid used inks. Their unique physical and chemin existing equipment or machinery for ical properties and widespread, uncon- handling and processing feed sampled trolled industrial applications have and tested to determine whether it caused PCB’s to be a persistent and contains PCB’s, or verify the absence ubiquitous contaminant in the environ- of PCB’s in such formulations by other ment, causing the contamination of appropriate means. On or before Sept. certain foods. In addition, incidents 4, 1973, any such fluid formulated with have occurred in which PCB’s have di- PCB’s must to the fullest extent pos- rectly contaminated animal feeds as a sible commensurate with current good result of industrial accidents (leakage manufacturing practices, be replaced or spillage of PCB fluids from plant with a heat exchange fluid that does equipment). These accidents in turn not contain PCB’s. cause the contamination of food in- (ii) Eliminate to the fullest extent tended for human consumption (meat, possible commensurate with current milk, and eggs). Investigations by the good manufacturing practices from the Food and Drug Administration have re- animal feed producing establishment vealed that heat exchange fluids for any PCB-containing lubricants for certain pasteurization equipment used equipment or machinery used for han- in processing animal feed contain dling or processing animal feed. PCB’s. Although heat exchange fluids (iii) Eliminate to the fullest extent in such equipment are considered to be possible commensurate with current in closed systems, leakage has occurred good manufacturing practices from the that resulted in direct contamination animal feed producing establishment of animal feed with PCB’s and subse- any other PCB-containing materials, quently resulted in the transfer of whenever there is a reasonable expecta- PCB’s to human food produced by ani- tion that such materials could cause mals consuming the contaminated animal feed to become contaminated with PCB’s either as a result of normal feed. The use of PCB-containing coat- use or as a result of accident, breakage, ings on the inner walls of silos has re- or other mishap. sulted in the contamination of silage which has in turn caused PCB residues (iv) The toxicity and other characteristics of fluids selected as PCB replace- in the milk of dairy cows consuming ments must be adequately determined the contaminated silage. Since PCB’s so that the least potentially hazardous are toxic chemicals, the PCB contami- replacement should be used. In making nation of food as a result of these and this determination with respect to a other incidents represent a hazard to given fluid, consideration should be public health. It is therefore necessary given to (a) its toxicity; (b) the max- to place certain restrictions on the in- imum quantity that could be spilled dustrial uses of PCB’s in the produc- onto a given quantity of food before it tion, handling, and storage of animal would be noticed, taking into account feed. its color and odor; (c) possible signaling (b) The following special provisions devices in the equipment to indicate a are necessary to preclude accidental loss of fluid, etc.; (d) and its environ- PCB contamination of animal feed: mental stability and tendency to sur- (1) Coatings or paints for use on the vive and be concentrated through the contact surfaces of feed storage areas food chain. The judgment as to wheth- may not contain PCB’s or any other er a replacement fluid is sufficiently harmful or deleterious substances like- non-hazardous is to be made on an indi- ly to contaminate feed. vidual installation and operation basis. (2) New equipment or machinery for (c) For the purpose of this section, handling or processing feed in or the provisions do not apply to elec- around an establishment producing trical transformers and condensers animal feed shall not contain PCB’s. containing PCB’s in sealed containers.

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(d) For the purpose of this section, isting approved application has been the term animal feed includes all arti- withdrawn. cles used for food or drink for animals (d) After September 29, 1977, animal other than man. drugs that contain hexachlorophene other than for preservative use on non- § 500.46 Hexachlorophene in animal food-producing animals at a level not drugs. exceeding 0.1 percent that are intro- (a) The Commissioner of Food and duced into interstate commerce shall Drugs has determined that there are no be deemed to be adulterated within the adequate data to establish that animal meaning of section 501(a)(5) of the act drugs containing hexachlorophene are (21 U.S.C. 351(a)(5)) unless such animal safe and effective for any animal use drug is the subject of a new animal other than in topical products for use drug application submitted pursuant to on non-food-producing animals as part paragraph (c) of this section. Action to of a product preservative system at a withdraw approval of new animal drug level not to exceed 0.1 percent; that applications will be initiated if supple- there is no information on the poten- mental new animal drug applications tial risk to humans from exposure to have not been submitted in accordance hexachlorophene by persons who apply with this section. animal products containing the drug at (e) New animal drug applications sub- levels higher than 0.1 percent; and that mitted for animal drugs containing there is likewise no information on hexachlorophene for use in or on food- human exposure to animals on which producing animals shall include ade- these animal drugs have been used and quate data to assure that edible prod- no information on possible residues of ucts from treated animals are safe for hexachlorophene in edible products of human consumption under the labeled food-producing animals treated with conditions of use. new animal drugs that contain any quantity of hexachlorophene. [42 FR 33725, July 1, 1977; 42 FR 37975, July 26, (b) Animal drugs containing 1977] hexachlorophene for other than preservative use on non-food-producing § 500.50 Propylene glycol in or on cat food. animals at levels not exceeding 0.1 percent are considered new animal drugs The Food and Drug Administration and shall be the subject of new animal has determined that propylene glycol drug applications (NADA’s). in or on cat food is not generally recog- (c) Any person currently marketing nized as safe and is a food additive sub- animal drugs that contain ject to section 409 of the Federal Food, hexachlorophene other than as part of Drug, and Cosmetic Act (the act). The a product preservative system for prod- Food and Drug Administration also has ucts used on non-food-producing ani- determined that this use of propylene mals at a level not exceeding 0.1 per- glycol is not prior sanctioned. cent shall submit a new animal drug [61 FR 19544, May 2, 1996] application, supplement an existing application, or reformulate the product by September 29, 1977. Each application Subpart C—Animal Drug Labeling or supplemental application shall in- Requirements clude adequate data to establish that the animal drug is safe and effective. If § 500.51 Labeling of animal drugs; mis- the animal drug is currently subject to branding. an approved new animal drug applica- (a) Among the representations on the tion, each reformulation shall require label or labeling of an animal drug an approved supplemental application. which will render the drug misbranded The interim marketing of these animal are any broad statements suggesting or drugs may continue until the applica- implying that the drug is not safe and tion has been approved, until it has effective for use when used in accord- been determined that the application is ance with labeling direction, or sug- not approvable under the provisions of gesting or implying that the labeling § 514.111 of this chapter, or until an ex- does not contain adequate warnings or

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adequate directions for use. Such state- (b) The unqualified use of the term ments include, but are not limited to: conditioner and similar terms in the la- (1) Any statement that disclaims li- beling of a product intended for use in ability when the drug is used in accord- or on animals implies that such prod- ance with directions for use contained uct is capable of a therapeutic effect(s) on the label or labeling. and causes such a product to be a drug (2) Any statement that disclaims li- within the meaning of section 201(g) of ability when the drug is used under the act. The unqualified use of such ‘‘abnormal’’ or ‘‘unforeseeable’’ condi- terms in a product’s labeling fails to tions. provide adequate directions and indica- (3) Any statement limiting the war- tions for use of such product and ranty for the products to a warranty causes it to be misbranded within the that the drug in the package contains meaning of section 502(a) and (f)(1) of the ingredients listed on the label. the act. The term conditioner and simi- (b) This regulation is not intended to lar terms may be used in labeling only prohibit any liability disclaimer that when appropriately qualified so as to purports to limit the amount of dam- fully inform the user regarding the in- ages or that sets forth the legal theory tended use(s) of the product. A product under which damages are to be recov- labeled as a ‘‘conditioner’’ or with a ered. similar term can be either a food or (c) Any person wishing to obtain an drug depending upon the manner in evaluation of an animal drug liability which the term is qualified in the la- disclaimer under this regulation may beling to reflect the product’s intended submit it to Division of Compliance, use. (HFV–230), Center for Veterinary Medi- (c) An article so qualified as to be cine, Food and Drug Administration, represented as a drug must be the sub- 7500 Standish Pl., Rockville, MD 20855. ject of an approved new animal drug A supplemental NADA providing appro- application unless the use of the article priately revised labeling shall be sub- under the conditions set forth in its la- mitted for any approved new animal beling is generally recognized as safe drug the labeling of which is not in and effective among experts qualified compliance with this regulation. by scientific training and experience to evaluate the safety and effectiveness of [41 FR 8473, Feb. 27, 1976, as amended at 54 FR 18279, Apr. 28, 1989; 57 FR 6475, Feb. 25, animal drugs. 1992] § 500.55 Exemption from certain drug- § 500.52 Use of terms such as ‘‘tonic’’, labeling requirements. ‘‘tone’’, ‘‘toner’’, or ‘‘conditioner’’ in (a) Section 201.105(c) of this chapter the labeling of preparations in- provides that in the case of certain tended for use in or on animals. drugs for which directions, hazards, (a) The use of terms such as tonic, warnings, and use information are tone, toner, and similar terms in the la- commonly known to practitioners li- beling of a product intended for use in censed by law, such information may or on animals implies that such prod- be omitted from the dispensing pack- uct is capable of a therapeutic effect(s) age. Under this proviso, the Commis- and causes such a product to be a drug sioner of Food and Drugs will offer an within the meaning of section 201(g) of opinion, upon written request, stating the Federal Food, Drug, and Cosmetic reasonable grounds therefore on a pro- Act. The unqualified use of such terms posal to omit such information from in a product’s labeling fails to provide the dispensing package. adequate directions and indications for (b) The Commissioner of Food and use of such product and causes it to be Drugs has considered submitted mate- misbranded within the meaning of sec- rial covering a number of drug prod- tion 502(a) and (f)(1) of the act. The ucts and has offered the opinion that terms tonic, tone, toner, and similar the following drugs when intended for terms may be used in labeling only those veterinary uses for which they when appropriately qualified so as to are now generally employed by the vet- fully inform the user regarding the in- erinary medical profession, should be tended use(s) of the product. exempt from the requirements of

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§ 201.105(c) of this chapter, provided agents. In connection with this prob- that they meet the conditions pre- lem the Food and Drug Administration scribed in this paragraph. Preparations has obtained the views of the Advisory that are not in dosage unit form (for Committee on Veterinary Medicine, example, solutions) will be regarded as and other experts, and has concluded meeting the conditions with respect to that adequate directions for over-the- the maximum quantity of drug per dos- counter sale of epinephrine injection age unit if they are prepared in a man- 1:1,000 can be prepared. ner that enables accurate and ready ad- (b) In view of the above, the Commis- ministration of a quantity of drug not sioner of Food and Drugs has concluded in excess of the stated maximum per that it is in the public interest to make dosage unit: epinephrine injection 1:1,000 available Atropine sulfate. As an injectable for cattle, for sale without a prescription provided goats, horses, pigs, and sheep, not in excess that it is packaged in vials not exceed- of 15 milligrams per dosage unit; as an ing 10 milliliters and its label bears, in injectable for cats and dogs, not in excess addition to other required information, of 0.6 milligram per dosage unit. the following statements in a promi- Barbital sodium. For oral use in cats and nent and conspicuous manner: ‘‘For dogs, not in excess of 300 milligrams per dosage unit. emergency use only in treating Epinephrine injection. 1:1,000. For cats, dogs, anaphylactoid shock. Usual Dosage: cattle, goats, horses, pigs, and sheep (ex- Cattle, horses, sheep, and swine—1 cept as provided in § 500.65). cubic centimeter per 100 pounds of body Morphine sulfate. As an injectable for dogs, weight. Inject subcutaneously’’. not in excess of 15 milligrams per dosage (c) The labeling must also bear a de- unit. scription of the symptoms of Pentobarbital sodium. For oral use in cats and dogs, not in excess of 100 milligrams per anaphylactoid shock including glassy dosage unit. eyes, increased salivation, grinding of Phenobarbital sodium. For oral use in cats and the teeth, rapid breathing, muscular dogs, not in excess of 100 milligrams per tremors, staggering gait, and collapse dosage unit. with death following. These symptoms Procaine hydrochloride injection. Containing may appear shortly after injection of a not in excess of 2 percent procaine hydro- bacterin, vaccine, or antibiotic. chloride, with or without epinephrine up to a concentration of 1:50,000. For use in cats, dogs, cattle, goats, horses, pigs, and sheep. Subpart E—Regulation of Carcino- Thyroid. For oral use in dogs, not in excess of genic Compounds Used in 60 milligrams per dosage unit. Food-Producing Animals Subpart D—Requirements for SOURCE: 52 FR 49586, Dec. 31, 1987, unless Specific Animal Drugs otherwise noted. § 500.65 Epinephrine injection 1:1,000 in 10-milliliter containers for emer- § 500.80 Scope of this subpart. gency treatment of anaphylactoid (a) The Federal Food, Drug, and Cos- shock in cattle, horses, sheep, and metic Act requires that sponsored com- swine. pounds intended for use in food-pro- (a) Anaphylactoid reactions in cattle, ducing animals be shown to be safe and horses, sheep, and swine occur occa- that food produced from animals ex- sionally from the injection of anti- posed to these compounds be shown to biotics, bacterins, and vaccines. Ade- be safe for consumption by people. The quate directions for use of these anti- statute prohibits the use in food-pro- biotics, bacterins, and vaccines can ducing animals of any compound found generally be written for use by the to induce cancer when ingested by peo- laity and thus are available to live- ple or animals unless it can be deter- stock producers. Epinephrine injection mined by methods of examination pre- is effective for the treatment of scribed or approved by the Secretary (a anaphylactoid reactions in animals and function delegated to the Commis- would be of value in saving lives of ani- sioner of Food and Drugs) that no res- mals if it were readily available at the idue of that compound will be found in time of administration of the causative the food produced from those animals

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under conditions of use reasonably cer- not produced in sufficient quantity to tain to be followed in practice. This support the animal’s growth, develop- subpart identifies the steps a sponsor ment, function, or reproduction, e.g., of a compound shall follow to secure vitamins, essential minerals, essential the approval of the compound. FDA amino acids, and essential fatty acids. guidance documents contain the proce- These compounds must be supplied dures and protocols FDA recommends from external sources. for the implementation of this subpart. FDA means the Food and Drug Ad- These guidance documents are avail- ministration. able from the Division of Dockets Man- Limit of detection (LOD) means the agement (HFA–305), Food and Drug Ad- lowest concentration of analyte that ministration, 5630 Fishers Lane, rm. can be confirmed by the approved regu- 1061, Rockville, MD 20852. Requests for latory method. these guidance documents should be Marker residue means the residue se- identified with Docket No. 1983D–0288. lected for assay whose concentration is (b) If FDA concludes on the basis of in a known relationship to the con- the threshold assessment that a spon- centration of the residue of carcino- sor shall conduct carcinogenicity test- genic concern in the last tissue to de- ing on the sponsored compound, FDA plete to its S . will also determine whether and to m Preslaughter withdrawal period or milk what extent the sponsor shall conduct carcinogenicity testing on metabolites discard time means the time after ces- of the sponsored compound. The bio- sation of administration of the spon- assays that a sponsor conducts must be sored compound at which no residue is designed to assess carcinogenicity and detectable in the edible product using to determine the quantitative aspects the approved regulatory method (i.e., of any carcinogenic response. the marker residue is below the LOD). (c) If FDA concludes on the basis of Regulatory method means the aggre- the threshold assessment or at a later gate of all experimental procedures for time during the approval process that measuring and confirming the presence the data show that the sponsored com- of the marker residue of the sponsored pound and its metabolites should not compound in the target tissue of the be subject to this subpart, FDA will target animal. continue to consider the compound for Rm means the concentration of the approval under the general safety pro- marker residue in the target tissue visions of the act for risks other than when the residue of carcinogenic con- cancer. cern is equal to Sm. (d) This subpart does not apply to es- Residue means any compound present sential nutrients. in edible tissues of the target animal which results from the use of the spon- [52 FR 49586, Dec. 31, 1987, as amended at 59 sored compound, including the spon- FR 14365, Mar. 28, 1994; 62 FR 66983, Dec. 23, 1997; 65 FR 56480, Sept. 19, 2000; 67 FR 78174, sored compound, its metabolites, and Dec. 23, 2002; 68 FR 24879, May 9, 2003; 69 FR any other substances formed in or on 17292, Apr. 2, 2004] food because of the sponsored compound’s use. § 500.82 Definitions. Residue of carcinogenic concern means (a) The definitions and interpreta- all compounds in the total residue of a tions contained in section 201 of the act demonstrated carcinogen excluding apply to those terms when used in this any compounds judged by FDA not to subpart. present a carcinogenic risk. (b) The following definitions apply to Sm means the concentration of a res- this subpart: idue of carcinogenic concern in a spe- Act means the Federal Food, Drug, cific edible tissue corresponding to no and Cosmetic Act (sections 201–901, 52 significant increase in the risk of can- Stat. 1040 et seq. as amended (21 U.S.C. cer to the human consumer. For the 301–392)). purpose of § 500.84(c)(1), FDA will as- Essential nutrients means compounds sume that this Sm will correspond to that are found in the tissues of un- the concentration of residue in a spe- treated, healthy target animals and cific edible tissue that corresponds to a

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maximum lifetime risk of cancer in the lyze the data from the bioassays using test animals of 1 in 1 million. a statistical extrapolation procedure as So means the concentration of a res- outlined in paragraph (c)(1) of this sec- idue of carcinogenic concern in the tion or evaluate an alternate procedure total human diet that represents no proposed by the sponsor as provided in significant increase in the risk of can- § 500.90. In either case, paragraphs (c)(2) cer to the human consumer. For the and (3) of this section apply. purpose of § 500.84(c)(1), FDA will as- (1) For each substance tested in sepa- sume that this So will correspond to rate bioassays, FDA will calculate the the concentration of test compound in concentration of the residue of carcino- the total diet of test animals that cor- genic concern that corresponds to a responds to a maximum lifetime risk of maximum lifetime risk to the test ani- cancer in the test animals of 1 in 1 mil- mal of 1 in 1 million. FDA will des- lion. ignate the lowest value obtained as So. Sponsor means the person or organi- Because the total diet is not derived zation proposing or holding an ap- from food-producing animals, FDA will proval by FDA for the use of a spon- make corrections for food intake. FDA sored compound. will designate as Sm the concentration Sponsored compound means any drug of residue in a specific edible tissue or food additive or color additive pro- corresponding to a maximum lifetime posed for use, or used, in food-pro- risk of cancer in test animals of 1 in 1 ducing animals or in their feed. million. Target animals means the production (2) From the appropriate residue class of animals in which a sponsored chemistry data FDA will calculate the compound is proposed or intended for Rm as described in § 500.86(c). The spon- use. sor must provide a regulatory method Target tissue means the edible tissue in accordance with § 500.88(b). FDA will selected to monitor for residues in the calculate the LOD of the method from target animals, including, where appro- data submitted by the sponsor under priate, milk or eggs. § 500.88. The LOD must be less than or Test animals means the species se- equal to Rm. lected for use in the toxicity tests. (3) FDA will conclude that the provi- Threshold assessment means FDA’s re- sions of this subpart are satisfied when view of data and information about a no residue of the compound is detect- sponsored compound to determine able (that is, the marker residue is whether chronic bioassays in test ani- below the LOD) using the approved reg- mals are necessary to resolve questions ulatory method under the conditions of concerning the carcinogenicity of the use of the sponsored compound, includ- compound. ing any required preslaughter with- [52 FR 49586, Dec. 31, 1987, as amended at 67 drawal period or milk discard time. FR 78174, Dec. 23, 2002; 77 FR 50593, Aug. 22, [52 FR 49586, Dec. 31, 1987, as amended at 67 2012] FR 78174, Dec. 23, 2002; 77 FR 50593, Aug. 22, 2012] § 500.84 Conditions for approval of the sponsored compound. § 500.86 Marker residue and target tis- (a) On the basis of the results of the sue. chronic bioassays and other informa- (a) For each edible tissue, the spon- tion, FDA will determine whether any sor shall measure the depletion of the of the substances tested are carcino- residue of carcinogenic concern until genic. its concentration is at or below Sm. (b) If FDA concludes that the results (b) In one or more edible tissues, the of the bioassays do not establish car- sponsor shall also measure the deple- cinogenicity, then FDA will not sub- tion of one or more potential marker ject the sponsored compound to the re- residues until the concentration of the mainder of the requirements of this residue of carcinogenic concern is at or subpart. below Sm. (c) For each sponsored compound (c) From these data, FDA will select that FDA decides should be regulated a target tissue and a marker residue as a carcinogen, FDA will either ana- and designate the concentration of

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marker residue (Rm) that the regu- pound, and set forth clearly the rea- latory method must be capable of sons why the alternative procedures measuring in the target tissue. FDA will provide the basis for concluding will select Rm such that the absence of that approval of the compound satisfies the marker residue in the target tissue the requirements of the anticancer pro- above Rm can be taken as confirmation visions of the act. If the Commissioner that the residue of carcinogenic con- determines that waiver of any of the cern does not exceed Sm in each of the requirements of this subpart is appro- edible tissues and, therefore, that the priate, the Commissioner will state the residue of carcinogenic concern in the basis for that determination in the reg- diet of people does not exceed So. ulation approving marketing of the (d) When a compound is to be used in sponsored compound. milk- or egg-producing animals, milk (Approved by the Office of Management and or eggs must be the target tissue in ad- Budget under control number 0910–0228) dition to the tissue selected to monitor for residues in the edible carcass. § 500.92 Implementation. (Approved by the Office of Management and (a) This subpart E applies to all new Budget under control number 0910–0228) animal drug applications, food additive petitions, and color additive petitions § 500.88 Regulatory method. concerning any compound intended for (a) The sponsor shall submit for eval- use in food-producing animals (includ- uation and validation a regulatory ing supplemental applications and method developed to monitor compli- amendments to petitions). ance with FDA’s operational definition (b) This subpart E also applies in the of no residue. following manner to compounds al- (b) The regulatory method must be ready approved: able to confirm the identity of the (1) For those compounds that FDA marker residue in the target tissue at determines may induce cancer when in- a minimum concentration cor- gested by man or animals, i.e., suspect responding to the Rm. FDA will deter- carcinogens, §§ 500.80(b), 500.82, and mine the LOD from the submitted ana- 500.90 apply. lytical method validation data. (2) For those compounds that FDA (c) FDA will publish in the FEDERAL determines have been shown to induce REGISTER the complete regulatory cancer when ingested by man or ani- method for ascertaining the marker mals, §§ 500.82 through 500.90 apply. residue in the target tissue in accordance with the provisions of sections Subpart F—Methods for Detection 409(c)(3)(A), 512(d)(1)(I), and 721(b)(5)(B) of Residues of Carcinogenic of the act. Compounds Used in Food- (Approved by the Office of Management and Producing Animals Budget under control number 0910–0228)

[52 FR 49586, Dec. 31, 1987, as amended at 67 SOURCE: 76 FR 72618, Nov. 25, 2011, unless FR 78174, Dec. 23, 2002] otherwise noted.

§ 500.90 Waiver of requirements. § 500.1410 N-methyl-2-pyrrolidone. In response to a petition or on the (a) Standard for residues. No residues Commissioner’s own initiative, the of n-methyl-2-pyrrolidone may be Commissioner may waive, in whole or found in the uncooked edible tissues of in part, the requirements of this sub- cattle as determined by a method enti- part except those provided under tled ‘‘Method of Analysis: N-methyl-2- § 500.88. A petition for this waiver may pyrrolidone,’’ September 26, 2011, Cen- be filed by any person who would be ad- ter for Veterinary Medicine, Food and versely affected by the application of Drug Administration, which is incor- the requirements to a particular com- porated by reference with the approval pound. The petition shall explain and of the Director of the Federal Register document why the requirements from under 5 U.S.C. 522(a) and 1 CFR part 51. which a waiver is requested are not You may obtain a copy of the method reasonably applicable to the com- from the Communications Staff (HFV–

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12), Center for Veterinary Medicine, 501.103 Petitions requesting exemptions Food and Drug Administration, 7519 from or special requirements for label Standish Pl., Rockville, MD 20855, 240– declaration of ingredients. 276–9120; or go to http://www.fda.gov/ 501.105 Declaration of net quantity of con- AboutFDA/CentersOffices/OfficeofFoods/ tents when exempt. CVM/CVMFOIAElectronicReadingRoom/ 501.110 Animal feed labeling; collective default.htm. You may inspect a copy at names for feed ingredients. the Division of Dockets Management AUTHORITY: 15 U.S.C. 1453, 1454, 1455; 21 (HFA–305), Food and Drug Administra- U.S.C. 321, 331, 342, 343, 348, 371. tion, 5630 Fishers Lane, Rm. 1061, Rock- SOURCE: 41 FR 38619, Sept. 10, 1976, unless ville, MD 20852, (301) 827–6860, between 9 otherwise noted. a.m. and 4 p.m., Monday through Fri- day or at the National Archives and Records Administration (NARA). For Subpart A—General Provisions information on the availability of this § 501.1 Principal display panel of pack- material at NARA, call (202) 741–6030, age form animal food. or go to: http://www.archives.gov/federal- register/cfr/ibr-locations.html. The term principal display panel as it (b) Related conditions of use. See applies to food in package form and as §§ 522.814 and 522.955 of this chapter. used in this part, means the part of a label that is most likely to be dis- [76 FR 72618, Nov. 25, 2011, as amended at 77 played, presented, shown, or examined FR 9528, Feb. 17, 2012] under customary conditions of display for retail sale. The principal display PART 501—ANIMAL FOOD panel shall be large enough to accom- LABELING modate all the mandatory label information required to be placed thereon Subpart A—General Provisions by this part with clarity and conspicu- Sec. ousness and without obscuring design, 501.1 Principal display panel of package vignettes, or crowding. Where packages form animal food. bear alternate principal display panels, 501.2 Information panel of package for ani- information required to be placed on mal food. the principal display panel shall be du- 501.3 Identity labeling of animal food in plicated on each principal display package form. panel. For the purpose of obtaining 501.4 Animal food; designation of ingredients. uniform type size in declaring the 501.5 Animal food; name and place of busi- quantity of contents for all packages of ness of manufacturer, packer, or dis- substantially the same size, the term tributor. area of the principal display panel means 501.8 Labeling of animal food with number the area of the side or surface that of servings. bears the principal display panel, 501.15 Animal food; prominence of required which area shall be: statements. 501.17 Animal food labeling warning state- (a) In the case of a rectangular pack- ments. age where one entire side properly can 501.18 Misbranding of animal food. be considered to be the principal display panel side, the product of the Subpart B—Specific Animal Food Labeling height times the width of that side; Requirements (b) In the case of a cylindrical or 501.22 Animal foods; labeling of spices, nearly cylindrical container, 40 percent flavorings, colorings, and chemical pre- of the product of the height of the con- servatives. tainer times the circumference; (c) In the case of any otherwise Subparts C–E [Reserved] shaped container, 40 percent of the total surface of the container: Provided, Subpart F—Exemptions From Animal Food however, That where such container Labeling Requirements presents an obvious principal display 501.100 Animal food; exemptions from label- panel such as the top of a triangular or ing. circular package, the area shall consist

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of the entire top surface. In deter- lished. The requirements for conspicu- mining the area of the principal dis- ousness and legibility shall include the play panel, exclude tops, bottoms, specifications of §§ 501.15 and 501.105(h) flanges at tops and bottoms of cans, (1) and (2). and shoulders and necks of bottles or (1) Packaged foods are exempt from jars. In the case of cylindrical or near- the type size requirements of this para- ly cylindrical containers, information graph: Provided, That: required by this part to appear on the (i) The package is designed such that principal display panel shall appear it has a surface area that can bear an within that 40 percent of the circum- information panel and/or an alternate ference which is most likely to be dis- principal display panel. played, presented, shown, or examined (ii) The area of surface available for under customary conditions of display labeling on the principal display panel for retail sale. of the package as this term is defined § 501.2 Information panel of package in § 501.1 is less than 10 square inches. for animal food. (iii) The label information includes a (a) The term information panel as it full list of ingredients in accordance applies to packaged food means that with regulations in this part. part of the label immediately contig- (iv) The information required by uous and to the right of the principal paragraph (b) of this section appears on display panel as observed by an indi- the principal display panel or informa- vidual facing the principal display tion panel label in accordance with the panel with the following exceptions: provisions of this paragraph (c) except (1) If the part of the label imme- that the type size is not less than 3⁄64 diately contiguous and to the right of inch in height. the principal display panel is too small (2) Packaged foods are exempt from to accommodate the necessary infor- the type size requirements of this para- mation or is otherwise unusable label graph: Provided, That: space, e.g., folded flaps or can ends, the (i) The package is designed such that panel immediately contiguous and to it has a single obvious principal display the right of this part of the label may panel as this term is defined in § 501.1 be used. and has no other available surface area (2) If the package has one or more al- for an information panel or alternate ternate principal display panels, the in- principal display panel. formation panel is immediately contig- (ii) The area of surface available for uous and to the right of any principal labeling on the principal display panel display panel. of the package as this term is defined (3) If the top of the container is the in § 501.1 is less than 12 square inches principal display panel and the pack- and bears all labeling appearing on the age has no alternate principal display package. panel, the information panel is any (iii) The label information includes a panel adjacent to the principal display full list of ingredients in accordance panel. with regulations in this part. (b) All information required to appear on the label of any package of (iv) The information required by food pursuant to §§ 501.4, 501.5, 501.8 and paragraph (b) of this section appears on 501.17 shall appear either on the prin- the single, obvious principal display cipal display panel or on the informa- panel in accordance with the provisions tion panel, unless otherwise specified of this paragraph (c) except that the by regulations in this chapter. type size is not less than 1⁄32 inch in (c) All information appearing on the height. principal display panel or the informa- (3) Packaged foods are exempt from tion panel pursuant to this section the type size requirements of this para- shall appear prominently and conspicu- graph: Provided, That: ously, but in no case may the letters (i) The package is designed such that and/or numbers be less than 1⁄16 inch in it has a total surface area available to height unless an exemption pursuant bear labeling of less than 12 square to paragraph (f) of this section is estab- inches.

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(ii) The label information includes a of its principal features a statement of full list of ingredients in accordance the identity of the commodity. with regulations in this part. (b) Such statement of identity shall (iii) The information required by be in terms of: paragraph (b) of this section appears on (1) The name now or hereafter speci- the principal display panel or informa- fied in or required by any applicable tion panel label in accordance with the Federal law or regulation; or, in the provisions of this paragraph (c) except absence thereof, that the type size is not less than 1⁄32 (2) The common or usual name of the inch in height. food; or, in the absence thereof, (d) All information required to ap- (3) An appropriately descriptive pear on the principal display panel or term, or when the nature of the food is on the information panel pursuant to obvious, a fanciful name commonly this section shall appear on the same used by the public for such food. panel unless there is insufficient space. (c) Where a food is marketed in var- In determining the sufficiency of the ious optional forms (whole, slices, available space, any vignettes, design, diced, etc.), the particular form shall and other nonmandatory label informa- be considered to be a necessary part of tion shall not be considered. If there is the statement of identity and shall be insufficient space for all of this infor- declared in letters of a type size bear- mation to appear on a single panel, it ing a reasonable relation to the size of may be divided between these two pan- the letters forming the other compo- els except that the information re- nents of the statement of identity; ex- quired pursuant to any given section or cept that if the optional form is visible part shall all appear on the same panel. through the container or is depicted by A food whose label is required to bear an appropriate vignette, the particular the ingredient statement on the prin- form need not be included in the state- cipal display panel may bear all other ment. This specification does not affect information specified in paragraph (b) the required declarations of identity of this section on the information under definitions and standards for panel. foods promulgated pursuant to section (e) All information appearing on the 401 of the act. information panel pursuant to this sec- (d) This statement of identity shall tion shall appear in one place without be presented in bold type on the prin- other intervening material. cipal display panel, shall be in a size (f) If the label of any package of food reasonably related to the most promi- is too small to accommodate all of the nent printed matter on such panel, and information required by §§ 501.4, 501.5, shall be in lines generally parallel to 501.8, and 501.17, the Commissioner may the base on which the package rests as establish by regulation an acceptable it is designed to be displayed. alternative method of disseminating (e) Under the provisions of section such information to the public, e.g., a 403(c) of the Federal Food, Drug, and type size smaller than one-sixteenth Cosmetic Act, a food shall be deemed inch in height, or labeling attached to to be misbranded if it is an imitation of or inserted in the package or available another food unless its label bears, in at the point of purchase. A petition re- type of uniform size and prominence, questing such a regulation, as an the word imitation and, immediately amendment to this paragraph shall be thereafter, the name of the food imi- submitted pursuant to part 10 of this tated. chapter. (1) A food shall be deemed to be an [41 FR 38619, Sept. 10, 1976, as amended at 42 imitation and thus subject to the re- FR 4716, Jan. 25, 1977; 42 FR 15675, Mar. 22, quirements of section 403(c) of the act 1977] if it is a substitute for and resembles another food but is nutritionally infe- § 501.3 Identity labeling of animal food rior to that food. in package form. (2) A food that is a substitute for and (a) The principal display panel of a resembles another food shall not be food in package form shall bear as one deemed to be an imitation provided it

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meets each of the following require- common or usual name in descending ments: order of predominance by weight on ei- (i) It is not nutritionally inferior to ther the principal display panel or the the food for which it substitutes and information panel in accordance with which it resembles. the provisions of § 501.2. (ii) Its label bears a common or usual (b) The name of an ingredient shall name that complies with the provisions be a specific name and not a collective of § 502.5 of this chapter and that is not (generic) name, except that: false or misleading, or in the absence (1) Spices, flavorings, colorings and of an existing common or usual name, chemical preservatives shall be de- an appropriately descriptive term that clared according to the provisions of is not false or misleading. The label § 501.22. may, in addition, bear a fanciful name (2) An ingredient which itself con- which is not false or misleading. tains two or more ingredients and (3) A food for which a common or which has an established common or usual name is established by regulation usual name, conforms to a standard es- (e.g., in a standard of identity pursuant tablished pursuant to the Meat Inspec- to section 401 of the act, in a common tion or Poultry Products Inspection or usual name regulation and may, in Acts by the U.S. Department of Agri- addition, bear a fanciful name which is culture, or conforms to a definition and not false or misleading, and established standard of identity established pursu- pursuant to part 502 of this chapter), ant to section 401 of the Federal Food, and which complies with all of the ap- Drug, and Cosmetic Act, shall be des- plicable requirements of such regula- ignated in the statement of ingredients tion(s), shall not be deemed to be an on the label of such food by either of imitation. (4) Nutritional inferiority includes: the following alternatives: (i) Any reduction in the content of an (i) By declaring the established com- essential nutrient that is present in a mon or usual name of the ingredient measurable amount. followed by a parenthetical listing of (ii) If the Commissioner concludes all ingredients contained therein in de- that a food is a substitute for and re- scending order of predominance except sembles another food but is inferior to that, if the ingredient is a food subject the food imitated for reasons other to a definition and standard of identity than those set forth in this paragraph, established in this subchapter E, only he may propose appropriate revisions the ingredients required to be declared to this regulation or he may propose a by the definition and standard of iden- separate regulation governing the par- tity need be listed; or ticular food. (ii) By incorporating into the state- (f) A label may be required to bear ment of ingredients in descending order the percentage(s) of a characterizing of predominance in the finished food, ingredient(s) or information con- the common or usual name of every cerning the presence or absence of an component of the ingredient without ingredient(s) or the need to add an in- listing the ingredient itself. gredient(s) as part of the common or (3) Skim milk, concentrated skim usual name of the food pursuant to milk, reconstituted skim milk, and part 502 of this chapter. nonfat dry milk may be declared as skim milk or nonfat milk. [41 FR 38619, Sept. 10, 1976, as amended at 42 FR 14091, Mar. 15, 1977; 54 FR 18279, Apr. 28, (4) Milk, concentrated milk, reconsti- 1989] tuted milk, and dry whole milk may be declared as milk. § 501.4 Animal food; designation of in- (5) Bacterial cultures may be de- gredients. clared by the word cultured followed by (a) Ingredients required to be de- the name of the substrate, e.g., made clared on the label of a food, including from cultured skim milk or cultured but- foods that comply with standards of termilk. identity that require labeling in com- (6) Sweetcream buttermilk, con- pliance with this part 501, except those centrated sweetcream buttermilk, re- exempted by § 501.100, shall be listed by constituted sweetcream buttermilk,

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and dried sweetcream buttermilk may the amount of water needed to recon- be declared as buttermilk. stitute the ingredient to single (7) Whey, concentrated whey, recon- strength. Any water added in excess of stituted whey, and dried whey may be the amount of water needed to recon- declared as whey. stitute the ingredient to single (8) Cream, reconstituted cream, dried strength shall be declared as water in cream, and plastic cream (sometimes the ingredient statement. known as concentrated milkfat) may be declared as cream. [41 FR 38619, Sept. 10, 1976, as amended at 42 FR 14091, Mar. 15, 1977; 60 FR 38480, July 27, (9) Butteroil and anhydrous butterfat 1995] may be declared as butterfat. (10) Dried whole eggs, frozen whole § 501.5 Animal food; name and place of eggs, and liquid whole eggs may be de- business of manufacturer, packer, clared as eggs. or distributor. (11) Dried egg whites, frozen egg (a) The label of a food in packaged whites, and liquid egg whites may be form shall specify conspicuously the declared as egg whites. name and place of business of the man- (12) Dried egg yolks, frozen egg yolks, ufacturer, packer, or distributor. and liquid egg yolks may be declared as egg yolks. (b) The requirement for declaration (13) A livestock or poultry feed may of the name of the manufacturer, pack- be declared by a collective name listed er, or distributor shall be deemed to be in § 501.110 if it is an animal feed within satisfied, in the case of a corporation, the meaning of section 201(w) of the act only by the actual corporate name, and meets the requirements for the use which may be preceded or followed by of a collective name as prescribed in the name of the particular division of § 501.110 for certain feed ingredients. the corporation. In the case of an indi- (14) [Reserved] vidual, partnership, or association, the (15) When all the ingredients of a name under which the business is con- wheat flour are declared in an ingre- ducted shall be used. dient statement, the principal ingre- (c) Where the food is not manufac- dient of the flour shall be declared by tured by the person whose name ap- the name(s) specified in §§ 137.105, pears on the label, the name shall be 137.200, 137.220, 137.225 of this chapter, qualified by a phrase that reveals the i.e., the first ingredient designated in connection such person has with such the ingredient list of flour, or food; such as ‘‘Manufactured for bromated flour, or enriched flour, or llllll,’’ ‘‘Distributed by self-rising flour is flour, white flour, llllll,’’ or any other wording wheat flour, or plain flour; the first in- that expresses the facts. gredient designated in the ingredient (d) The statement of the place of list of durum flour is durum flour; the business shall include the street ad- first ingredient designated in the ingre- dress, city, state, and ZIP Code; how- dient list of whole wheat flour, or ever, the street address may be omitted bromated whole wheat flour is whole if it is shown in a current city direc- wheat flour, graham flour, or entire tory or telephone directory. The re- wheat flour; and the first ingredient quirement for inclusion of the ZIP designated in the ingredient list of Code shall apply only to consumer whole durum wheat flour is whole commodity labels developed or revised durum wheat flour. after the effective date of this section. (c) When water is added to reconsti- In the case of nonconsumer packages, tute, completely or partially, an ingre- the ZIP Code shall appear either on the dient permitted by paragraph (b) of label or the labeling (including in- this section to be declared by a class voice). name, the position of the ingredient (e) If a person manufactures, packs, class name in the ingredient statement or distributes a food at a place other shall be determined by the weight of than his principal place of business, the the unreconstituted ingredient plus the label may state the principal place of weight of the quantity of water added business in lieu of the actual place to reconstitute that ingredient, up to where such food was manufactured or

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packed or is to be distributed, unless therefor, and each of which is so de- such statement would be misleading. signed as to render it likely to be, under customary conditions of pur- § 501.8 Labeling of animal food with chase, the part or panel displayed; number of servings. (3) The failure of the label to extend (a) The label of any package of a food over the area of the container or pack- which bears a representation as to the age available for such extension, so as number of servings contained in such to provide sufficient label space for the package shall bear in immediate con- prominent placing of such word, state- junction with such statement, and in ment, or information; the same size type as is used for such (4) Insufficiency of label space (for statement, a statement of the net the prominent placing of such word, quantity (in terms of weight, measure, statement, or information) resulting or numerical count) of each such serv- from the use of label space for any ing; however, such statement may be word, statement, design, or device expressed in terms that differ from the which is not required by or under au- terms used in the required statement thority of the act to appear on the of net quantity of contents (for exam- label; ple, cupfuls, tablespoonfuls, etc.) when (5) Insufficiency of label space (for such differing term is common to cook- the prominent placing of such word, ery and describes a constant quantity. statement, or information) resulting Such statement may not be misleading from the use of label space to give main any particular. A statement of the terially greater conspicuousness to any number of units in a package is not in other word, statement, or information, itself a statement of the number of or to any design or device; or servings. (b) If there exists a voluntary prod- (6) Smallness or style of type in uct standard promulgated pursuant to which such word, statement, or infor- the procedures found in 15 CFR part 10 mation appears, insufficient back- by the Department of Commerce, quan- ground contrast, obscuring designs or titatively defining the meaning of the vignettes, or crowding with other written, printed, or graphic matter. term serving with respect to a particular food, then any label representa- (b) No exemption depending on insuf- tion as to the number of servings in ficiency of label space, as prescribed in such packaged food shall correspond regulations promulgated under section with such quantitative definition. 403(e) or (i) of the act, shall apply if (Copies of published standards are such insufficiency is caused by: available upon request from the Na- (1) The use of label space for any tional Bureau of Standards, Depart- word, statement, design, or device ment of Commerce, Washington, DC which is not required by or under au- 20234.) thority of the act to appear on the label; § 501.15 Animal food; prominence of (2) The use of label space to give required statements. greater conspicuousness to any word, (a) A word, statement, or other infor- statement, or other information that is mation required by or under authority required by section 403(f) of the act; or of the act to appear on the label may (3) The use of label space for any rep- lack that prominence and conspicuous- resentation in a foreign language. ness required by section 403(f) of the (c)(1) All words, statements, and act by reason (among other reasons) of: other information required by or under (1) The failure of such word, state- authority of the act to appear on the ment, or information to appear on the label or labeling shall appear thereon part or panel of the label which is pre- in the English language: Provided, how- sented or displayed under customary ever, That in the case of articles dis- conditions of purchase; tributed solely in the Commonwealth (2) The failure of such word, state- of Puerto Rico or in a territory where ment, or information to appear on two the predominant language is one other or more parts or panels of the label, than English, the predominant lan- each of which has sufficient space guage may be substituted for English.

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(2) If the label contains any represen- (i) Products expelled in the form of a tation in a foreign language, all words, foam or cream, which contain less than statements, and other information re- 10 percent propellant in the container. quired by or under authority of the act (ii) Products in a container with a to appear on the label shall appear physical barrier that prevents escape of thereon in the foreign language. the propellant at the time of use. (3) If any article of labeling (other (iii) Products of a net quantity of than a label) contains any representa- contents of less than 2 ozs that are de- tion in a foreign language, all words, signed to release a measured amount of statements, and other information re- product with each valve actuation. quired by or under authority of the act (iv) Products of a net quantity of 1 to appear on the label or labeling shall contents of less than ⁄2 oz. appear on such article of labeling. (c) Animal food containing or manufactured with a chlorofluorocarbon or other § 501.17 Animal food labeling warning ozone-depleting substance. Labeling re- statements. quirements for animal foods that contain or are manufactured with a (a) Self-pressurized containers. (1) The chlorofluorocarbon or other ozone-de- label of a food packaged in a self-pres- pleting substance designated by the surized container and intended to be Environmental Protection Agency expelled from the package under pres- (EPA) are set forth in 40 CFR part 82. sure shall bear the following warning: Warning Avoid spraying in eyes. Con- [41 FR 38619, Sept. 10, 1976, as amended at 42 tents under pressure. Do not puncture FR 22033, Apr. 29, 1977; 61 FR 20101, May 3, or incinerate. Do not store at tempera- 1996] ° ture above 120 F. Keep out of reach of § 501.18 Misbranding of animal food. children. (a) Among representations in the la- (2) In the case of products intended beling of a food which render such food for use by children, the phrase ‘‘except misbranded is a false or misleading under adult supervision’’ may be added representation with respect to another at the end of the last sentence in the food or a drug, device, or cosmetic. warning required by paragraph (a)(1) of (b) The labeling of a food which con- this section. tains two or more ingredients may be (3) In the case of products packaged misleading by reason (among other rea- in glass containers, the word ‘‘break’’ sons) of the designation of such food in may be substituted for the word such labeling by a name which includes ‘‘puncture’’ in the warning required by or suggests the name of one or more paragraph (a)(1) of this section. but not all such ingredients, even (4) The words ‘‘Avoid spraying in though the names of all such ingredi- eyes’’ may be deleted from the warning ents are stated elsewhere in the label- required by paragraph (a)(1) of this sec- ing. tion in the case of a product not ex- (c) Among representations in the la- pelled as a spray. beling of a food which render such food (b) Self-pressurized containers with misbranded is any representation that halocarbon or hydrocarbon propellants. expresses or implies a geographical ori- (1) In addition to the warning required gin of the food or any ingredient of the by paragraph (a) of this section, the food except when such representation label of a food packaged in a self-pres- is either: surized container in which the propel- (1) A truthful representation of geo- lant consists in whole or in part of a graphical origin. halocarbon or a hydrocarbon shall bear (2) A trademark or trade name pro- the following warning: vided that as applied to the article in Warning Use only as directed. Inten- question its use is not deceptively tional misuse by deliberately concen- misdescriptive. A trademark or trade trating and inhaling the contents can name comprised in whole or in part of be harmful or fatal. geographical words shall not be consid- (2) The warning required by para- ered deceptively misdescriptive if it: graph (b)(1) of this section is not re- (i) Has been so long and exclusively quired for the following products: used by a manufacturer or distributor

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that it is generally understood by the declared as spice and coloring unless de- consumer to mean the product of a par- clared by their common or usual name. ticular manufacturer or distributor; or (3) The term natural flavor or natural (ii) Is so arbitrary or fanciful that it flavoring means the essential oil, oleo- is not generally understood by the con- resin, essence or extractive, protein hy- sumer to suggest geographic origin. drolysate, distillate, or any product of (3) A part of the name required by ap- roasting, heating or enzymolysis, plicable Federal law or regulation. which contains the flavoring constitu- (4) A name whose market signifi- ents derived from a spice, fruit or fruit cance is generally understood by the juice, vegetable or vegetable juice, edi- consumer to connote a particular class, ble yeast, herb, bark, bud, root, leaf or kind, type, or style of food rather than similar plant material, meat, seafood, to indicate geographical origin. poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring Subpart B—Specific Animal Food rather than nutritional. Natural fla- Labeling Requirements vors, include the natural essence or extractives obtained from plants listed in § 501.22 Animal foods; labeling of spices, flavorings, colorings, and subpart A of part 582 of this chapter, chemical preservatives. and the substances listed in § 172.510 of this chapter. (a)(1) The term artificial flavor or arti- (4) The term artificial color or artificial ficial flavoring means any substance, coloring means any color additive as de- the function of which is to impart fla- fined in § 70.3(f) of this chapter. vor, which is not derived from a spice, (5) The term chemical preservative fruit or fruit juice, vegetable or vege- means any chemical that, when added table juice, edible yeast, herb, bark, to food, tends to prevent or retard de- bud, root, leaf or similar plant mate- terioration thereof, but does not in- rial, meat, fish, poultry, eggs, dairy clude common salt, sugars, vinegars, products, or fermentation products spices, or oils extracted from spices, thereof. Artificial flavor includes the substances added to food by direct ex- substances listed in §§ 172.515(b) and posure thereof to wood smoke, or 582.60 of this chapter except where chemicals applied for their insecticidal these are derived from natural sources. or herbicidal properties. (2) The term spice means any aro- (b) A food which is subject to the re- matic vegetable substance in the quirements of section 403(k) of the act whole, broken, or ground form, except shall bear labeling, even though such for those substances which have been food is not in package form. traditionally regarded as foods, such as (c) A statement of artificial fla- onions, garlic and celery; whose signifi- voring, artificial coloring, or chemical cant function in food is seasoning rath- preservative shall be placed on the er than nutritional; that is true to food, or on its container or wrapper, or name; and from which no portion of on any two or all of these, as may be any volatile oil or other flavoring prin- necessary to render such statement ciple has been removed. Spices include likely to be read by the ordinary indi- the spices listed in subpart A of part vidual under customary conditions of 582 of this chapter, such as the fol- purchase and use of such food. lowing: (d) A food shall be exempt from com- Allspice, Anise, Basil, Bay leaves, Caraway pliance with the requirements of sec- seed, Cardamon, Celery seed, Chervil, Cin- tion 403(k) of the act if it is not in namon, Cloves, Coriander, Cumin seed, Dill package form and the units thereof are seed, Fennel seed, Fenugreek, Ginger, so small that a statement of artificial Horseradish, Mace, Marjoram, Mustard flavoring, artificial coloring, or chem- flour, Nutmeg, Oregano, Paprika, Parsley, ical preservative, as the case may be, Pepper, black; Pepper, white; Pepper, red; Rosemary, Saffron, Sage, Savory, Star ani- cannot be placed on such units with seed, Tarragon, Thyme, Turmeric. such conspicuousness as to render it likely to be read by the ordinary indi- Paprika, turmeric, and saffron or other vidual under customary conditions of spices which are also colors, shall be purchase and use.

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(e) A food shall be exempt while held statement of ingredients in the fol- for sale from the requirements of sec- lowing way: tion 403(k) of the act (requiring label (1) Spice, natural flavor, and artifi- statement of any artificial flavoring, cial flavor may be declared as spice, artificial coloring, or chemical preserv- natural flavor, or artificial flavor, or any atives) if said food, having been re- combination thereof, as the case may ceived in bulk containers at a retail es- be. tablishment, is displayed to the pur- (2) An incidental additive in a food, chaser with either (1) the labeling of originating in a spice or flavor used in the bulk container plainly in view or the manufacture of the food, need not (2) a counter card, sign, or other appro- be declared in the statement of ingredi- priate device bearing prominently and ents if it meets the requirements of conspicuously the information required § 501.100(a)(3). to be stated on the label pursuant to (3) Substances obtained by cutting, section 403(k) of the act. grinding, drying, pulping, or similar (f) A fruit or vegetable shall be ex- processing of tissues derived from fruit, empt from compliance with the re- vegetable, meat, fish, or poultry, e.g., quirements of section 403(k) of the act powdered or granulated onions, garlic with respect to a chemical preservative powder, and celery powder, are com- applied to the fruit or vegetable as a monly understood by consumers to be pesticide chemical prior to harvest. food rather than flavor and shall be de- (g) A flavor shall be labeled in the clared by their common or usual name. following way when shipped to a food (4) Any salt (sodium chloride) used as manufacturer or processor (but not a an ingredient in food shall be declared consumer) for use in the manufacture by its common or usual name salt. of a fabricated food, unless it is a fla- (5) Any monosodium glutamate used vor for which a standard of identity as an ingredient in food shall be declared by its common or usual name has been promulgated, in which case it monosodium glutamate. shall be labeled as provided in the (6) Any pyroligneous acid or other ar- standard: tificial smoke flavors used as an ingre- (1) If the flavor consists of one ingredient in a food may be declared as arti- dient, it shall be declared by its com- ficial flavor or artificial smoke flavor. No mon or usual name. representation may be made, either di- (2) If the flavor consists of two or rectly or implied, that a food flavored more ingredients, the label either may with pyroligneous acid or other artifi- declare each ingredient by its common cial smoke flavor has been smoked or or usual name or may state ‘‘All flavor has a true smoked flavor, or that a sea- ingredients contained in this product soning sauce or similar product con- are approved for use in a regulation of taining pyroligneous acid or other arti- the Food and Drug Administration.’’ ficial smoke flavor and used to season Any flavor ingredient not contained in or flavor other foods will result in a one of these regulations, and any non- smoked product or one having a true flavor ingredient, shall be separately smoked flavor. listed on the label. (i) If the label, labeling, or adver- (3) In cases where the flavor contains tising of a food makes any direct or in- a solely natural flavor(s), the flavor direct representations with respect to shall be so labeled, e.g., strawberry fla- the primary recognizable flavor(s), by vor, banana flavor, or natural strawberry word, vignette, e.g., depiction of a fruit, flavor. In cases where the flavor con- or other means, or if for any other rea- tains both a natural flavor and an arti- son the manufacturer or distributor of ficial flavor, the flavor shall be so la- a food wishes to designate the type of beled, e.g., natural and artificial straw- flavor in the food other than through berry flavor. In cases where the flavor the statement of ingredients, such fla- contains a solely artificial flavor(s), vor shall be considered the character- the flavor shall be so labeled, e.g., arti- izing flavor and shall be declared in the ficial strawberry flavor. following way: (h) The label of a food to which flavor (1) If the food contains no artificial is added shall declare the flavor in the flavor which simulates, resembles or

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reinforces the characterizing flavor, (3) Wherever the name of the charac- the name of the food on the principal terizing flavor appears on the label display panel or panels of the label (other than in the statement of ingre- shall be accompanied by the common dients) so conspicuously as to be easily or usual name of the characterizing fla- seen under customary conditions of vor in letters not less than one-half the purchase, the words prescribed by this height of the letters used in the name paragraph shall immediately and con- of the food, except that: spicuously precede or follow such (i) If the food is one that is com- name, without any intervening writ- monly expected to contain a character- ten, printed, or graphic matter, except: izing food ingredient, and the food con- (i) Where the characterizing flavor tains natural flavor derived from such and a trademark or brand are pre- ingredient and an amount of character- sented together, other written, printed, izing ingredient insufficient to inde- or graphic matter that is a part of or is pendently characterize the food, or the associated with the trademark or food contains no such ingredient, the brand may intervene if the required name of the characterizing flavor may words are in such relationship with the be immediately preceded by the word trademark or brand as to be clearly re- natural and shall be immediately fol- lated to the characterizing flavor; and lowed by the word flavored in letters (ii) If the finished product contains not less than one-half the height of the more than one flavor subject to the re- letters in the name of the character- quirements of this paragraph, the izing flavor. statements required by this paragraph (ii) If none of the natural flavor used need appear only once in each state- in the food is derived from the product ment of characterizing flavors present whose flavor is simulated, the food in in such food. which the flavor is used shall be labeled either with the flavor of the prod- (iii) If the finished product contains uct from which the flavor is derived or three or more distinguishable charac- as artificially flavored. terizing flavors, or a blend of flavors (iii) If the food contains both a char- with no primary recognizable flavor, acterizing flavor from the product the flavor may be declared by an appro- whose flavor is simulated and other priately descriptive generic term in natural flavor which simulates, resem- lieu of naming each flavor. bles or reinforces the characterizing (4) A flavor supplier shall certify, in flavor, the food shall be labeled in ac- writing, that any flavor he supplies cordance with the introductory text which is designated as containing no and paragraph (i)(1)(i) of this section artificial flavor does not, to the best of and the name of the food shall be im- his knowledge and belief, contain any mediately followed by the words with artificial flavor, and that he has added other natural flavor in letters not less no artificial flavor to it. The require- than one-half the height of the letters ment for such certification may be sat- used in the name of the characterizing isfied by a guarantee under section flavor. 303(c)(2) of the act which contains such (2) If the food contains any artificial a specific statement. A flavor used flavor which simulates, resembles or shall be required to make such a writ- reinforces the characterizing flavor, ten certification only where he adds to the name of the food on the principal or combines another flavor with a fla- display panel or panels of the label vor which has been certified by a flavor shall be accompanied by the common supplier as containing no artificial fla- or usual name(s) of the characterizing vor, but otherwise such user may rely flavor, in letters not less than one-half upon the supplier’s certification and the height of the letters used in the need make no separate certification. name of the food and the name of the All such certifications shall be re- characterizing flavor shall be accom- tained by the certifying party through- panied by the word(s) artificial or artifi- out the period in which the flavor is cially flavored, in letters not less than supplied and for a minimum of 3 years one-half the height of the letters in the thereafter, and shall be subject to the name of the characterizing flavor. following conditions:

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(i) The certifying party shall make the Secretary’s representative shall be such certifications available upon re- limited to inspection and review of in- quest at all reasonable hours to any ventories and ingredient records for duly authorized officer, or employee of those certifications which are to be the Food and Drug Administration or verified. any other employee acting on behalf of (v) Review of flavor ingredient the Secretary of Health and Human records shall be limited to the quali- Services. Such certifications are re- tative formula and shall not include garded by the Food and Drug Adminis- the quantitative formula. The person tration as reports to the government verifying the certifications may make and as guarantees or other under- only such notes as are necessary to en- takings within the meaning of section able him to verify such certification. 301(h) of the act and subject the certi- Only such notes or such flavor ingre- fying party to the penalties for making dient records as are necessary to verify any false report to the government such certification or to show a poten- under 18 U.S.C. 1001 and any false guar- tial or actual violation may be re- antee or undertaking under section moved or transmitted from the certi- 303(a) of the act. The defenses provided fying party’s place of business: Pro- under section 303(c)(2) of the act shall vided, That, where such removal or be applicable to the certifications pro- transmittal is necessary for such pur- vided for in this section. poses the relevant records and notes (ii) Wherever possible, the Food and shall be retained as separate docu- Drug Administration shall verify the ments in Food and Drug Administra- accuracy of a reasonable number of tion files, shall not be copied in other certifications made pursuant to this reports, and shall not be disclosed pub- section, constituting a representative licly other than in a judicial pro- sample of such certifications, and shall ceeding brought pursuant to the act or not request all such certifications. 18 U.S.C. 1001. (iii) Where no person authorized to (j) A food to which a chemical pre- provide such information is reasonably servative(s) is added shall, except when available at the time of inspection, the exempt pursuant to § 501.100, bear a certifying party shall arrange to have such person and the relevant materials label declaration stating both the com- and records ready for verification as mon or usual name of the ingredient(s) soon as practicable; provided that, and a separate description of its func- whenever the Food and Drug Adminis- tion, e.g., preservative, to retard spoilage, tration has reason to believe that the a mold inhibitor, to help protect flavor or supplier or user may utilize this period to promote color retention. to alter inventories or records, such ad- (k) The label of an animal food to ditional time shall not be permitted. which any coloring has been added Where such additional time is pro- shall declare the coloring in the state- vided, the Food and Drug Administra- ment of ingredients in the manner tion may require the certifying party specified in paragraphs (k)(1) and (k)(2) to certify that relevant inventories of this section. have not been materially disturbed and (1) A color additive or the lake of a relevant records have not been altered color additive subject to certification or concealed during such period. under section 721(c) of the act shall be (iv) The certifying party shall pro- declared by the name of the color addi- vide, to an officer or representative tive listed in the applicable regulation duly designated by the Secretary, such in part 74 or part 82 of this chapter, ex- qualitative statement of the composi- cept that it is not necessary to include tion of the flavor or product covered by the ‘‘FD&C’’ prefix or the term ‘‘No.’’ the certification as may be reasonably in the declaration, but the term expected to enable the Secretary’s rep- ‘‘Lake’’ shall be included in the dec- resentatives to determine which rel- laration of the lake of the certified evant raw and finished materials and color additive (e.g., Blue 1 Lake). Man- flavor ingredient records are reason- ufacturers may parenthetically declare ably necessary to verify the certifi- an appropriate alternative name of the cations. The examination conducted by certified color additive following its

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common or usual name as specified in spicuously the information required to part 74 or part 82 of this chapter. be stated on the label pursuant to sec- (2) Color additives not subject to cer- tion 403(i)(2) of the act. tification may be declared as ‘‘Artifi- (3) Incidental additives that are cial Color,’’ ‘‘Artificial Color Added,’’ present in a food at insignificant levels or ‘‘Color Added’’ (or by an equally in- and do not have any technical or func- formative term that makes clear that a tional effect in that food. For the pur- color additive has been used in the poses of this paragraph (a)(3), inci- food). Alternatively, such color addi- dental additives are: tives may be declared as ‘‘Colored with (i) Substances that have no technical llll’’ or ‘‘llll color,’’ the blank or functional effect but are present in a to be filled with the name of the color food by reason of having been incor- additive listed in the applicable regula- porated into the food as an ingredient tion in part 73 of this chapter. of another food, in which the substance did have a functional or technical ef- [41 FR 38619, Sept. 10, 1976, as amended at 42 FR 14091, Mar. 15, 1977; 42 FR 15675, Mar. 22, fect. 1977; 76 FR 71254, Nov. 17, 2011] (ii) Processing aids, which are as follows: (a) Substances that are added to a Subparts C–E [Reserved] food during the processing of such food but are removed in some manner from Subpart F—Exemptions From Ani- the food before it is packaged in its fin- mal Food Labeling Require- ished form. ments (b) Substances that are added to a food during processing, are converted § 501.100 Animal food; exemptions into constituents normally present in from labeling. the food, and do not significantly in- (a) The following foods are exempt crease the amount of the constituents from compliance with the require- naturally found in the food. ments of section 403(i)(2) of the act (re- (c) Substances that are added to a quiring a declaration on the label of food for their technical or functional the common or usual name of each in- effect in the processing but are present gredient when the food is fabricated in the finished food at insignificant from two or more ingredients). levels and do not have any technical or (1) An assortment of different items functional effect in that food. of food, when variations in the items (iii) Substances migrating to food that make up different packages from equipment or packaging or other- packed from such assortment normally wise affecting food that are not food occur in good packing practice and additives as defined in section 201(s) of when such variations result in vari- the act; or if they are food additives as ations in the ingredients in different so defined, they are used in conformity packages, with respect to any ingre- with regulations established pursuant dient that is not common to all pack- to section 409 of the act. ages. Such exemption, however, shall (b) A food repackaged in a retail es- be on the condition that the label shall tablishment is exempt from the fol- bear, in conjunction with the names of lowing provisions of the act if the con- such ingredients as are common to all ditions specified are met. packages, a statement (in terms that (1) Section 403(e)(1) of the act (requir- are as informative as practicable and ing a statement on the label of the that are not misleading) indicating by name and place of business of the man- name other ingredients which may be ufacturer, packer, or distributor). present. (2) Section 403(g)(2) of the act (requir- (2) A food having been received in ing the label of a food which purports bulk containers at a retail establish- to be or is represented as one for which ment, if displayed to the purchaser a definition and standard of identity with either (i) the labeling of the bulk has been prescribed to bear the name of container plainly in view or (ii) a the food specified in the definition and counter card, sign, or other appropriate standard and, insofar as may be re- device bearing prominently and con- quired by the regulation establishing

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the standard the common names of the make such copies available for inspec- optional ingredients present in the tion at any reasonable hour to any offi- food), if the food is displayed to the cer or employee of the Department who purchaser with its interstate labeling requests them. clearly in view, or with a counter card, (e) Conditions affecting expiration of sign, or other appropriate device bear- exemptions. ing prominently and conspicuously the (1) An exemption of a shipment or information required by these provi- other delivery of a food under para- sions. graph (d)(1) of this section shall, at the (3) Section 403(i)(1) of the act (requir- beginning of the act of removing such ing the label to bear the common or shipment or delivery, or any part usual name of the food), if the food is thereof, from such establishment be- displayed to the purchaser with its come void ab initio if the food com- interstate labeling clearly in view, or prising such shipment, delivery, or part with a counter card, sign, or other appropriate device bearing prominently is adulterated or misbranded within and conspicuously the common or the meaning of the act when so re- usual name of the food, or if the com- moved. mon or usual name of the food is clear- (2) An exemption of a shipment or ly revealed by its appearance. other delivery of a food under para- (c) [Reserved] graph (d)(2) of this section shall be- (d) Except as provided by paragraphs come void ab initio with respect to the (e) and (f) of this section, a shipment or person who introduced such shipment other delivery of a food which is, in ac- or delivery into interstate commerce cordance with the practice of the trade, upon refusal by such person to make to be processed, labeled, or repacked in available for inspection a copy of the substantial quantity at an establish- agreement, as required by paragraph ment other than that where originally (d)(2) of this section. processed or packed, shall be exempt, (3) An exemption of a shipment or during the time of introduction into other delivery of a food under para- and movement in interstate commerce graph (d)(2) of this section shall expire: and the time of holding in such estab- (i) At the beginning of the act of re- lishment, from compliance with the la- moving such shipment or delivery, or beling requirements of section 403 (c), any part thereof, from such establish- (e), (g), (h), (i), (j) and (k) of the act if: ment if the food comprising such ship- (1) The person who introduced such ment, delivery, or part is adulterated shipment or delivery into interstate or misbranded within the meaning of commerce is the operator of the estab- the act when so removed; or lishment where such food is to be proc- (ii) Upon refusal by the operator of essed, labeled, or repacked; or the establishment where such food is to (2) In case such person is not such op- be processed, labeled, or repacked, to erator, such shipment or delivery is make available for inspection a copy of made to such establishment under a the agreement as required by such written agreement, signed by and con- paragraph. taining the post office addresses of such person and such operator, and (f) [Reserved] containing such specifications for the (g) The label declaration of a harm- processing, labeling, or repacking, as less marker used to identify a par- the case may be, of such food in such ticular manufacturer’s product may re- establishment as will ensure, if such sult in unfair competition through re- specifications are followed, that such vealing a trade secret. Exemption from food will not be adulterated or mis- the label declaration of such a marker branded within the meaning of the act is granted, therefore, provided that the upon completion of such processing, la- following conditions are met: beling, or repacking. Such person and (1) The person desiring to use the such operator shall each keep a copy of marker without label declaration of its such agreement until 2 years after the presence has submitted to the Commis- final shipment or delivery of such food sioner of Food and Drugs full informa- from such establishment, and shall tion concerning the proposed usage and

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the reasons why he believes label dec- priate term or terms to be used for laration of the marker should be sub- such commodity. ject to this exemption; and (b)(1) Statements of weight shall be (2) The person requesting the exemp- in terms of avoirdupois pound and tion has received from the Commis- ounce. sioner of Food and Drugs a finding that (2) Statements of fluid measure shall the marker is harmless and that the be in terms of the U.S. gallon of 231 exemption has been granted. cubic inches and quart, pint, and fluid ounce subdivisions thereof, and shall: § 501.103 Petitions requesting exemp- (i) In the case of frozen food that is tions from or special requirements sold and consumed in a frozen state, for label declaration of ingredients. express the volume at the frozen tem- The Commissioner of Food and perature. Drugs, either on his own initiative or (ii) In the case of refrigerated food on behalf of any interested person who that is sold in the refrigerated state, has submitted a petition pursuant to express the volume at 40 °F (4 °C). part 10 of this chapter may issue a pro- (iii) In the case of other foods, ex- posal to amend § 501.4 to specify the press the volume at 68 °F (20 °C). manner in which an ingredient(s) shall (3) Statements of dry measure shall be declared, i.e., by specific or class be in terms of the U.S. bushel of name, or § 501.100 to exempt an ingre- 2,150.42 cubic inches and peck, dry dient(s) from the requirements for quart, and dry pint subdivisions there- label declaration. of. [41 FR 38619, Sept. 10, 1976, as amended at 42 (c) When the declaration of quantity FR 15675, Mar. 22, 1977] of contents by numerical count does not give adequate information as to § 501.105 Declaration of net quantity the quantity of food in the package, it of contents when exempt. shall be combined with such statement (a) The principal display panel of a of weight, measure, or size of the indi- food in package form shall bear a dec- vidual units of the foods as will provide laration of the net quantity of con- such information. tents. This shall be expressed in the (d) The declaration may contain terms of weight, measure, numerical common or decimal fractions. A com- count, or a combination of numerical mon fraction shall be in terms of count and weight or measure. The halves, quarters, eighths, sixteenths, or statement shall be in terms of fluid thirty-seconds; except that if there ex- measure if the food is liquid, or in ists a firmly established general con- terms of weight if the food is solid, sumer usage and trade custom of em- semisolid, or viscous, or a mixture of ploying different common fractions in solid and liquid; except that such state- the net quantity declaration of a par- ment may be in terms of dry measure ticular commodity, they may be em- if the food is a fresh fruit, fresh vege- ployed. A common fraction shall be re- table, or other dry commodity that is duced to its lowest terms; a decimal customarily sold by dry measure. If fraction shall not be carried out to there is a firmly established general more than two places. A statement consumer usage and trade custom of that includes small fractions of an declaring the contents of a liquid by ounce shall be deemed to permit small- weight, or a solid, semisolid, or viscous er variations than one which does not product by fluid measure, it may be include such fractions. used. Whenever the Commissioner de- (e) The declaration shall be located termines that an existing practice of on the principal display panel of the declaring net quantity of contents by label, and with respect to packages weight, measure, numerical count, or a bearing alternate principal panels it combination in the case of a specific shall be duplicated on each principal packaged food does not facilitate value display panel. comparisons by consumers and offers (f) The declaration shall appear as a opportunity for consumer confusion, he distinct item on the principal display will by regulation designate the appro- panel, shall be separated (by at least a

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space equal to the height of the let- used, it is the lower case letter ‘‘o’’ or tering used in the declaration) from its equivalent that shall meet the min- other printed label information appear- imum standards. ing above or below the declaration and (3) When fractions are used, each (by at least a space equal to twice the component numeral shall meet one- width of the letter ‘‘N’’ of the style of half the minimum height standards. type used in the quantity of contents (i) The declaration shall be in letters statement) from other printed label in- and numerals in a type size established formation appearing to the left or right in relationship to the area of the prin- of the declaration. It shall not include cipal display panel of the package and any term qualifying a unit of weight, shall be uniform for all packages of measure, or count (such as jumbo quart substantially the same size by com- and full gallon) that tends to exag- plying with the following type speci- gerate the amount of the food in the fications: container. It shall be placed on the (1) Not less than 1⁄16 inch in height on principal display panel within the bot- packages the principal display panel of tom 30 percent of the area of the label which has an area of 5 square inches or panel in lines generally parallel to the less. base on which the package rests as it is (2) Not less than 1⁄8 inch in height on designed to be displayed: Provided, packages the principal display panel of That on packages having a principal which has an area of more than 5 but display panel of 5 square inches or less, not more than 25 square inches. the requirement for placement within (3) Not less than 3⁄16 inch in height on the bottom 30 percent of the area of the packages the principal display panel of label panel shall not apply when the which has an area of more than 25 but declaration of net quantity of contents not more than 100 square inches. 1 meets the other requirements of this (4) Not less than ⁄4 inch in height on part. packages the principal display panel of (g) The declaration shall accurately which has an area of more than 100 1 reveal the quantity of food in the pack- square inches, except not less than ⁄2 age exclusive of wrappers and other inch in height if the area is more than material packed therewith; provided 400 square inches. that in the case of foods packed in con- Where the declaration is blown, em- tainers designed to deliver the food bossed, or molded on a glass or plastic under pressure, the declaration shall surface rather than by printing, typ- state the net quantity of the contents ing, or coloring, the lettering sizes that will be expelled when the instruc- specified in paragraphs (i) (1) through tions for use as shown on the container (4) of this section shall be increased by are followed. The propellant is included 1⁄16 of an inch. in the net quantity declaration. (j) On packages containing less than (h) The declaration shall appear in 4 pounds or 1 gallon and labeled in conspicuous and easily legible boldface terms of weight or fluid measure: print or type in distinct contrast (by (1) The declaration shall be expressed typography, layout, color, embossing, both in ounces, with identification by or molding) to other matter on the weight or by liquid measure and, if ap- package; except that a declaration of plicable (1 pound or 1 pint or more) fol- net quantity blown, embossed, or mold- lowed in parentheses by a declaration ed on a glass or plastic surface is per- in pounds for weight units, with any re- missible when all label information is mainder in terms of ounces or common so formed on the surface. Requirements or decimal fractions of the pound (see of conspicuousness and legibility shall examples set forth in paragraphs (m) include the specifications that: (1) and (2) of this section), or in the (1) The ratio of height to width (of case of liquid measure, in the largest the letter) shall not exceed a differen- whole units (quarts, quarts and pints, tial of 3 units to 1 unit (no more than or pints, as appropriate) with any re- 3 times as high as it is wide). mainder in terms of fluid ounces or (2) Letter heights pertain to upper common or decimal fractions of the case or capital letters. When upper and pint or quart (see examples in para- lower case or all lower case letters are graphs (m) (3) and (4) of this section).

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(2) If the net quantity of contents not in terms of quart and ounce such as declaration appears on a random pack- Net 56 fluid oz. (1 quart 24 ounces). age, that is a package which is one of (5) On a random package, declaration a lot, shipment, or delivery of packages of 3⁄4 pound avoirdupois may be ex- of the same consumer commodity with pressed as Net Wt. .75 lb. varying weights and with no fixed (6) A declaration of 21⁄2 gallons liquid weight pattern, it may, when the net measure shall be expressed as Net con- weight exceeds 1 pound, be expressed in tents 21⁄2 gallons, Net contents 2.5 gallons, terms of pounds and decimal fractions or Net contents 2 gallons 2 quarts and not of the pound carried out to not more as 2 gallons 4 pints. than two decimal places. When the net (n) For quantities, the following ab- weight does not exceed 1 pound, the breviations and none other may be em- declaration on the random package ployed (periods and plural forms are may be in decimal fractions of the optional): pound in lieu of ounces (see example in paragraph (m)(5) of this section). weight wt. pint pt. (3) The declaration may appear in ounce oz. quart qt. pound lb. fluid fl. more than one line. The term net gallon gal. weight shall be used when stating the net quantity of contents in terms of (o) Nothing in this section shall pro- weight. Use of the terms net or net con- hibit supplemental statements at loca- tents in terms of fluid measure or nu- tions other than the principal display merical count is optional. It is suffi- panel(s) describing in nondeceptive cient to distinguish avoirdupois ounce terms the net quantity of contents; from fluid ounce through association of provided, that such supplemental terms; for example, Net wt. 6 oz. or 6 oz. statements of net quantity of contents net wt. and 6 fl. oz. or net contents 6 fl. shall not include any term qualifying a oz. unit of weight, measure, or count that (k) On packages containing 4 pounds tends to exaggerate the amount of the or 1 gallon or more and labeled in food contained in the package; for ex- terms of weight or fluid measure, the ample, jumbo quart and full gallon. Dual declaration shall be expressed in or combination declarations of net pounds for weight units with any re- quantity of contents as provided for in mainder in terms of ounces or common paragraphs (a), (c), and (j) of this sec- or decimal fraction of the pound, or in tion (for example, a combination of net the case of fluid measure, it shall be weight plus numerical count, net con- expressed in the largest whole unit tents plus dilution directions of a con- (gallons followed by common or dec- centrate, etc.) are not regarded as sup- imal fraction of a gallon or by the next plemental net quantity statements and smaller whole unit or units (quarts, or may be located on the principal display quarts and pints)) with any remainder panel. in terms of fluid ounces or common or (p) A separate statement of the net decimal fractions of the pint or quart quantity of contents in terms of the (see paragraph (m)(6) of this section). metric system is not regarded as a sup- (l) [Reserved] plemental statement and an accurate (m) Examples: (1) A declaration of 11⁄2 statement of the net quantity of con- pounds weight shall be expressed as Net tents in terms of the metric system of Wt. 24 oz. (1 lb. 8 oz.), Net Wt. 24 oz. (11⁄2 weight or measure may also appear on lb.), or Net Wt. 24 oz. (1.5 lb.). the principal display panel or on other (2) A declaration of 3⁄4 pound avoirdu- panels. pois weight shall be expressed as Net (q) The declaration of net quantity of Wt. 12 oz. contents shall express an accurate (3) A declaration of 1 quart liquid statement of the quantity of contents measure shall be expressed as Net 32 fl. of the package. Reasonable variations oz. (1 qt.). caused by loss or gain of moisture dur- (4) A declaration of 13⁄4 quarts liquid ing the course of good distribution measure shall be expressed as Net con- practice or by unavoidable deviations tents 56 fluid ounces (1 quart 11⁄2 pints) or in good manufacturing practice will be as Net 56 fluid oz. (1 qt. 1 pt. 8 oz.), but recognized. Variations from stated

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quantity of contents shall not be un- essor directly to institutions operated reasonably large. by Federal, State or local govern- (r) [Reserved] ments: Provided, That: (s) On a multiunit retail package, a (1) The purchaser shall sign a state- statement of the quantity of contents ment at the time of sale stating that shall appear on the outside of the pack- he is aware that the product is mis- age and shall include the number of in- labeled to include acknowledgement of dividual units, the quantity of each in- the nature and extent of the dividual unit, and, in parentheses, the mislabeling, e.g., ‘‘Actual net weight total quantity of contents of the multi- may be as low as ll% below labeled unit package in terms of avoirdupois or quantity’’ and that any subsequent dis- fluid ounces, except that such declara- tribution by him of said product except tion of total quantity need not be fol- for his own institutional use is unlaw- lowed by an additional parenthetical ful. This statement shall be kept on declaration in terms of the largest file at the principal place of business of whole units and subdivisions thereof, the manufacturer or processor for 2 as required by paragraph (j)(1) of this years subsequent to the date of ship- section. A multiunit retail package ment of the product and shall be avail- may thus be properly labeled: 6–16 oz. able to the Food and Drug Administra- bottles—(96 fl. oz.) or 3–16 oz. cans—(net tion upon request. wt. 48 oz). For the purposes of this sec- (2) The product shall be labeled on tion, multiunit retail package means a the outside of its shipping container package containing two or more indi- with the statement(s): vidually packaged units of the iden- (i) When the variation concerns net tical commodity and in the same quan- weight and/or drained weight of vol- tity, intended to be sold as part of the ume—‘‘Product Mislabeled. Actual net multiunit retail package but capable of weight (drained weight or volume being individually sold in full compli- where appropriate) may be as low as ance with all requirements of the regu- ll% below labeled quantity. This lations in this part. Open multiunit re- Product Not for Retail Distribution,’’ tail packages that do not obscure the the blank to be filled in with the max- number of units nor prevent examina- imum percentage variance between the tion of the labeling on each of the indi- labeled and actual weight or volume of vidual units are not subject to this contents of the individual packages in paragraph if the labeling of each indi- the shipping container, and vidual unit complies with the require- (ii) When the variation is in regard to ments of paragraphs (f) and (i) of this a fill of container standard—‘‘Product section. Mislabeled. Actual fill may be as low (t) Where the declaration of net as ll% below standard of fill. This quantity of contents is in terms of net Product Not for Retail Distribution.’’ weight and/or drained weight or vol- (3) The statements required by para- ume and does not accurately reflect graphs (t)(2) (i) and (ii) of this section, the actual quantity of the contents or which may be consolidated where ap- the product falls below the applicable propriate, shall appear prominently standard of fill of container because of and conspicuously as compared to equipment malfunction or otherwise other printed matter on the shipping unintentional product variation, and container and in boldface print or type the label conforms in all other respects on a clear, contrasting background in to the requirements of this chapter (ex- order to render them likely to be read cept the requirement that food falling and understood by the purchaser under below the applicable standard of fill of ordinary conditions of purchase. container shall bear the general state- [41 FR 38619, Sept. 10, 1976, as amended at 54 ment of substandard fill specified in FR 18279, Apr. 28, 1989] § 564.14(b) of this chapter), the mislabeled food product, including any § 501.110 Animal feed labeling; collec- food product that fails to bear the gen- tive names for feed ingredients. eral statement of substandard fill spec- (a) An animal feed shall be exempt ified in § 564.14(b) of this chapter, may from the requirements of section be sold by the manufacturer or proc- 403(i)(2) of the act with respect to its

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label bearing the common or usual (6) Roughage products include one or names of the animal feed ingredients more of the following: Cobs, hulls, listed in paragraph (b) of this section husks, pulps, and straws. under the following prescribed conditions: PART 502—COMMON OR USUAL (1) The animal feed is intended solely NAMES FOR NONSTANDARDIZED for livestock and poultry. ANIMAL FOODS (2) The label of the animal feed bears the collective name(s) prescribed in Sec. paragraph (b) of this section in lieu of 502.5 General principles. the corresponding common or usual 502.19 Petitions. names of the individual feed ingredients contained therein. AUTHORITY: 21 U.S.C. 321, 343, 371. (3) The label of the animal feed otherwise conforms to the requirements of § 502.5 General principles. section 403(i)(2) of the act. (a) The common or usual name of a (4) The ingredients of any feed listed food, which may be a coined term, shall in paragraph (b) of this section neither accurately identify or describe, in as contain nor are food additives as de- simple and direct terms as possible, the fined in section 201(s) of the act unless basic nature of the food or its charac- provided for by and in conformity with terizing properties or ingredients. The applicable regulations established pur- name shall be uniform among all iden- suant to section 409 of the act. tical or similar products and may not (b) Each collective name referred to be confusingly similar to the name of in this paragraph may be used for the any other food that is not reasonably purpose of labeling where one or more encompassed within the same name. of the ingredients listed for that collec- Each class or subclass of food shall be tive name are present. The animal feed given its own common or usual name ingredients listed under each of the that states, in clear terms, what it is in collective names are the products de- a way that distinguishes it from dif- fined by the Association of American ferent foods. Feed Control Officials. The collective (b) The common or usual name of a names are as follows: food shall include the percentage(s) of (1) Animal protein products include one any characterizing ingredient(s) or or more of the following: Animal prod- component(s) when the proportion of ucts, marine products, and milk prod- such ingredient(s) or component(s) in ucts. the food has a material bearing on (2) Forage products include one or price or consumer acceptance or when more of the following: Alfalfa meals, the labeling or the appearance of the entire plant meals, hays, and stem food may otherwise create an erro- meals. neous impression that such ingre- (3) Grain products include one or more dient(s) or component(s) is present in of the following: Barley, grain sor- an amount greater than is actually the ghums, maize (corn), oats, rice, rye, case. The following requirements shall and wheat. apply unless modified by a specific reg- (4) Plant protein products include one ulation in this part. or more of the following: Algae meals, (1) The percentage of a characterizing coconut meals (copra), cottonseed ingredient or component shall be de- meals, guar meal, linseed meals, pea- clared on the basis of its quantity in nut meals, safflower meals, soybean the finished product (i.e., weight/ meals, sunflower meals, and yeasts. weight in the case of solids, or volume/ (5) Processed grain byproducts include volume in the case of liquids). one or more of the following: Brans, (2) The percentage of a characterizing brewers dried grains, distillers grains, ingredient or component shall be de- distillers solubles, flours, germ meals, clared by the words ‘‘containing (or gluten feeds, gluten meals, grits, contains) ll percent (or %) ll’’ or groats, hominy feeds, malt sprouts, ‘‘ll percent (or %) ll’’ with the first middlings, pearled, polishings, shorts, blank filled in with the percentage ex- and wheat mill run. pressed as a whole number not greater

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than the actual percentage of the in- taining (or contains) lllll’’ or ‘‘no gredient or component named and the lllll’’ or ‘‘does not contain second blank filled in with the common lllll’’, with the blank being filled or usual name of the ingredient or in with the common or usual name of component. The word ‘‘containing’’ (or the ingredient or component. ‘‘contains’’), when used, shall appear (2) The need for the user of a food to on a line immediately below the part of add any characterizing ingredient(s) or the common or usual name of the food component(s) shall be declared by an required by paragraph (a) of this sec- appropriate informative statement. tion. For each characterizing ingre- (3) The statement(s) required under dient or component, the words ‘‘ll paragraph (c) (1) and/or (2) of this sec- percent (or %) ll’’shall appear following or directly below the word tion shall appear following or directly ‘‘containing’’ (or ‘‘contains’’), or di- below the part of the common or usual rectly below the part of the common or name of the food required by para- usual name of the food required by graphs (a) and (b) of this section, in paragraph (a) of this section when the easily legible boldface print or type in word ‘‘containing’’ (or ‘‘contains’’) is distinct contrast to other printed or not used, in easily legible boldface graphic matter, and in a height not print or type in distinct contrast to less than the larger of the alternatives other printed or graphic matter, and in established under paragraph (b)(2) (i) a height not less than the larger of the and (ii) of this section. following alternatives: (d) A common or usual name of a (i) Not less than one-sixteenth inch food may be established by common in height on packages having a prin- usage or by establishment of a regula- cipal display panel with an area of 5 tion in this part, in a standard of iden- square inches or less and not less than tity, or in other regulations in this one-eighth inch in height if the area of chapter. the principal display panel is greater than 5 square inches; or [41 FR 38627, Sept. 10, 1976. Redesignated at (ii) Not less than one-half the height 42 FR 14091, Mar. 15, 1977] of the largest type appearing in the part of the common or usual name of § 502.19 Petitions. the food required by paragraph (a) of (a) The Commissioner of Food and this section. Drugs, either on his own initiative or (c) The common or usual name of a on behalf of any interested person who food shall include a statement of the has submitted a petition, may publish presence or absence of any character- a proposal to issue, amend, or revoke, izing ingredient(s) or component(s) under this part, a regulation pre- and/or the need for the user to add any scribing a common or usual name for a characterizing ingredient(s) or compo- food, pursuant to part 10 of this chap- nent(s) when the presence or absence of ter. such ingredient(s) or component(s) in (b) If the principal display panel of a the food has a material bearing on food for which a common or usual price or consumer acceptance or when the labeling or the appearance of the name regulation is established is too food may otherwise create an erro- small to accommodate all mandatory neous impression that such ingre- requirements, the Commissioner may dient(s) or component(s) is present establish by regulation an acceptable when it is not, and consumers may oth- alternative, e.g., a smaller type size. A erwise be misled about the presence or petition requesting such a regulation, absence of the ingredient(s) or compo- which would amend the applicable reg- nent(s) in the food. The following re- ulation, shall be submitted pursuant to quirements shall apply unless modified part 10 of this chapter. by a specific regulation in this part. [42 FR 4716, Jan. 25, 1977; 42 FR 10980, Feb. 25, (1) The presence or absence of a char- 1977. Redesignated at 42 FR 14091, Mar. 15, acterizing ingredient or component 1977, and amended at 42 FR 15675, Mar. 22, shall be declared by the words ‘‘con- 1977; 42 FR 24254, May 13, 1977] taining (or contains) llll’’ or ‘‘con-

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PART 507—CURRENT GOOD MAN- 507.53 Requirements applicable to a preventive controls qualified individual and a UFACTURING PRACTICE, HAZARD qualified auditor. ANALYSIS, AND RISK–BASED PRE- 507.55 Implementation records required for VENTIVE CONTROLS FOR FOOD this subpart. FOR ANIMALS Subpart D—Withdrawal of a Qualified Facility Exemption Subpart A—General Provisions 507.60 Circumstances that may lead FDA to Sec. withdraw a qualified facility exemption. 507.1 Applicability and status. 507.62 Issuance of an order to withdraw a 507.3 Definitions. qualified facility exemption. 507.4 Qualifications of individuals who man- 507.65 Contents of an order to withdraw a ufacture, process, pack, or hold animal qualified facility exemption. food. 507.67 Compliance with, or appeal of, an 507.5 Exemptions. order to withdraw a qualified facility ex- 507.7 Requirements that apply to a qualified emption. facility. 507.69 Procedure for submitting an appeal. 507.10 Applicability of subparts C and E of 507.71 Procedure for requesting an informal this part to a facility solely engaged in hearing. the storage of unexposed packaged ani- 507.73 Requirements applicable to an informal food. mal hearing. 507.12 Applicability of this part to the hold- 507.75 Residing officer for an appeal and for ing and distribution of human food by- an informal hearing. products for use as animal food. 507.77 Timeframe for issuing a decision on an appeal. Subpart B—Current Good Manufacturing 507.80 Revocation of an order to withdraw a Practice qualified facility exemption. 507.83 Final agency action. 507.14 Personnel. 507.85 Reinstatement of a qualified facility 507.17 Plant and grounds. exemption that was withdrawn. 507.19 Sanitation. 507.20 Water supply and plumbing. Subpart E—Supply-Chain Program 507.22 Equipment and utensils. 507.25 Plant operations. 507.105 Requirement to establish and implement a supply-chain program. 507.27 Holding and distribution. 507.110 General requirements applicable to a 507.28 Holding and distribution of human supply-chain program. food by-products for use as animal food. 507.115 Responsibilities of the receiving facility. Subpart C—Hazard Analysis and Risk- 507.120 Using approved suppliers. Based Preventive Controls 507.125 Determining appropriate supplier verification activities (including deter- 507.31 Food safety plan. mining the frequency of conducting the 507.33 Hazard analysis. activity). 507.34 Preventive controls. 507.130 Conducting supplier verification ac- 507.36 Circumstances in which the owner, tivities for raw materials and other in- operator, or agent in charge of a manu- gredients. facturing/processing facility is not re- 507.135 Onsite audit. quired to implement a preventive con- 507.175 Records documenting the supply- trol. chain program. 507.37 Provision of assurances required under § 507.36(a)(2), (3), and (4). Subpart F—Requirements Applying to 507.38 Recall plan. Records That Must Be Established and 507.39 Preventive control management components. Maintained 507.40 Monitoring. 507.200 Records subject to the requirements 507.42 Corrective actions and corrections. of this subpart. 507.45 Verification. 507.202 General requirements applying to 507.47 Validation. records. 507.49 Verification of implementation and 507.206 Additional requirements applying to effectiveness. the food safety plan. 507.50 Reanalysis. 507.208 Requirements for record retention. 507.51 Modified requirements that apply to 507.212 Use of existing records. a facility solely engaged in the storage of 507.215 Special requirements applicable to a unexposed packaged animal food. written assurance.

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AUTHORITY: 21 U.S.C. 331, 342, 343, 350d note, also required to comply with subpart C 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271. of part 117 of this chapter, then the fa- SOURCE: 80 FR 56337, Sept. 17, 2015, unless cility may choose to comply with the otherwise noted. requirements in subpart C of part 117 as to the manufacturing, processing, Subpart A—General Provisions packing, and holding of animal food at the facility, instead of subpart C of § 507.1 Applicability and status. part 507, provided the food safety plan (a) The criteria and definitions in also addresses hazards for the animal this part apply in determining whether food, if applicable, that require a pre- an animal food is: ventive control. When applying the re- (1) Adulterated within the meaning quirements of part 117 of this chapter of: to animal food, the term ‘‘food’’ in part (i) Section 402(a)(3) of the Federal 117 includes animal food. Food, Drug, and Cosmetic Act in that the food has been manufactured under § 507.3 Definitions. such conditions that it is unfit for The definitions and interpretations food; or contained in section 201 of the Federal (ii) Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act apply to Food, Drug, and Cosmetic Act in that such terms when used in this part. The the food has been prepared, packed, or following definitions also apply: held under insanitary conditions Adequate means that which is needed whereby it may have become contami- to accomplish the intended purpose in nated with filth, or whereby it may keeping with good public (human and have been rendered injurious to health; animal) health practice. and Affiliate means any facility that con- (2) In violation of section 361 of the trols, is controlled by, or is under com- Public Health Service Act (42 U.S.C. mon control with another facility. 264). (b) The operation of a facility that Animal food means food for animals manufactures, processes, packs, or other than man and includes pet food, holds animal food for sale in the United animal feed, and raw materials and in- States if the owner, operator, or agent gredients. in charge of such facility is required to Audit means the systematic, inde- comply with, and is not in compliance pendent, and documented examination with, section 418 of the Federal Food, (through observation, investigation, Drug, and Cosmetic Act or subparts C, records review, discussions with em- D, E, or F of this part and § 507.7 is a ployees of the audited entity, and, as prohibited act under section 301(uu) of appropriate, sampling and laboratory the Federal Food, Drug, and Cosmetic analysis) to assess an audited entity’s Act. food safety processes and procedures. (c) Animal food covered by specific Calendar day means every day shown current good manufacturing practice on the calendar. regulations also is subject to the re- Correction means an action to iden- quirements of those regulations. tify and correct a problem that oc- (d) Except as provided by § 507.12, if a curred during the production of animal facility is required to comply with sub- food, without other actions associated part B of part 507 and is also required with a corrective action procedure to comply with subpart B of part 117 of (such as actions to reduce the likeli- this chapter because the facility manu- hood that the problem will recur, factures, processes, packs, or holds evaluate all affected animal food for human food and animal food, then the safety, and prevent affected animal facility may choose to comply with the food from entering commerce). requirements in subpart B of part 117, Critical control point means a point, instead of subpart B of part 507, as to step, or procedure in a food process at the manufacturing, processing, pack- which control can be applied and is es- ing, and holding of animal food at that sential to prevent or eliminate a food facility. If a facility is required to com- safety hazard or reduce such hazard to ply with subpart C of part 507 and is an acceptable level.

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Environmental pathogen means a place they were grown or raised and pathogen capable of surviving and per- preparing them for use as animal food. sisting within the manufacturing, proc- Harvesting is limited to activities per- essing, packing, or holding environ- formed on raw agricultural commod- ment such that food for animals may ities, or on processed foods created by be contaminated and may result in drying/dehydrating a raw agricultural foodborne illness if that animal food is commodity without additional manu- not treated to significantly minimize facturing/processing, on a farm. Har- or prevent the environmental patho- vesting does not include activities that gen. Examples of environmental patho- transform a raw agricultural com- gens for the purposes of this part in- modity into a processed food as defined clude Listeria monocytogenes and Sal- in section 201(gg) of the Federal Food, monella spp. but do not include the Drug, and Cosmetic Act. Examples of spores of pathogenic sporeforming bac- harvesting include cutting (or other- teria. wise separating) the edible portion of Facility means a domestic facility or the raw agricultural commodity from a foreign facility that is required to the crop plant and removing or trim- register under section 415 of the Fed- ming part of the raw agricultural com- eral Food, Drug, and Cosmetic Act, in modity (e.g., foliage, husks, roots, or accordance with the requirements of stems). Examples of harvesting also in- part 1, subpart H of this chapter. clude cooling, field coring, filtering, Farm means farm as defined in § 1.227 gathering, hulling, shelling, sifting, of this chapter. threshing, trimming of outer leaves of, FDA means the Food and Drug Ad- and washing raw agricultural commod- ministration. ities grown on a farm. Food means food as defined in section Hazard means any biological, chem- 201(f) of the Federal Food, Drug, and ical (including radiological), or phys- Cosmetic Act and includes raw mate- ical agent that has the potential to rials and ingredients. cause illness or injury in humans or Food-contact surfaces are those sur- animals. faces that contact animal food and Hazard requiring a preventive control those surfaces from which drainage, or means a known or reasonably foresee- other transfer, onto the animal food or able hazard for which a person knowl- onto surfaces that contact the animal edgeable about the safe manufacturing, food ordinarily occurs during the nor- processing, packing, or holding of animal course of operations. ‘‘Food-con- mal food would, based on the outcome tact surfaces’’ includes utensils and of a hazard analysis (which includes an animal food-contact surfaces of equip- assessment of the severity of the ill- ment. ness or injury to humans or animals if Full-time equivalent employee is a term the hazard were to occur and the prob- used to represent the number of em- ability that the hazard will occur in ployees of a business entity for the pur- the absence of preventive controls), es- pose of determining whether the busi- tablish one or more preventive controls ness qualifies for the small business ex- to significantly minimize or prevent emption. The number of full-time the hazard in an animal food and com- equivalent employees is determined by ponents to manage those controls (such dividing the total number of hours of as monitoring, corrections or correc- salary or wages paid directly to em- tive actions, verification, and records) ployees of the business entity and of all as appropriate to the animal food, the of its affiliates and subsidiaries by the facility, and the nature of the preven- number of hours of work in 1 year, 2,080 tive control and its role in the facili- hours (i.e., 40 hours × 52 weeks). If the ty’s food safety system. result is not a whole number, round Holding means storage of animal food down to the next lowest whole number. and also includes activities performed Harvesting applies to farms and farm incidental to storage of an animal food mixed-type facilities and means activi- (e.g., activities performed for the safe ties that are traditionally performed or effective storage of that animal on farms for the purpose of removing food, such as fumigating animal food raw agricultural commodities from the during storage, and drying/dehydrating

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raw agricultural commodities when the contaminated with filth, or that other- drying/dehydrating does not create a wise may cause animal food to be adul- distinct commodity (such as drying/de- terated. hydrating hay or alfalfa)). Holding also Mixed-type facility means an estab- includes activities performed as a prac- lishment that engages in both activi- tical necessity for the distribution of ties that are exempt from registration that animal food (such as blending of under section 415 of the Federal Food, the same raw agricultural commodity Drug, and Cosmetic Act and activities and breaking down pallets), but does that require the establishment to be not include activities that transform a registered. An example of such a facil- raw agricultural commodity into a ity is a ‘‘farm mixed-type facility,’’ processed food as defined in section which is an establishment that is a 201(gg) of the Federal Food, Drug, and farm, but also conducts activities out- Cosmetic Act. Holding facilities could side the farm definition that require include warehouses, cold storage facili- the establishment to be registered. ties, storage silos, grain elevators, and Monitor means to conduct a planned liquid-storage tanks. sequence of observations or measure- Known or reasonably foreseeable haz- ments to assess whether control meas- ard means a biological, chemical (in- ures are operating as intended. cluding radiological), or physical haz- Packing means placing animal food ard that is known to be, or has the po- into a container other than packaging tential to be, associated with the facil- the animal food and also includes re- ity or the animal food. packing and activities performed inci- Lot means the animal food produced dental to packing or repacking an ani- during a period of time and identified mal food (e.g., activities performed for by an establishment’s specific code. the safe or effective packing or repack- Manufacturing/processing means making of that animal food (such as sort- ing animal food from one or more in- ing, culling, grading, and weighing or gredients, or synthesizing, preparing, conveying incidental to packing or re- treating, modifying, or manipulating animal food, including food crops or in- packing)), but does not include activi- gredients. Examples of manufacturing/ ties that transform a raw agricultural processing activities include: Baking, commodity into a processed food as de- boiling, bottling, canning, cooking, fined in section 201(gg) of the Federal cooling, cutting, distilling, drying/de- Food, Drug, and Cosmetic Act. hydrating raw agricultural commod- Pathogen means a microorganism of ities to create a distinct commodity public (human or animal) health sig- (such as drying/dehydrating grapes to nificance. produce raisins), evaporating, evis- Pest refers to any objectionable ani- cerating, extracting juice, extruding, mals or insects including birds, ro- formulating, freezing, grinding, homog- dents, flies, and larvae. enizing, irradiating, labeling, milling, Plant means the building or struc- mixing, packaging (including modified ture, or parts thereof, used for or in atmosphere packaging), pasteurizing, connection with the manufacturing, peeling, pelleting, rendering, treating processing, packing, or holding of ani- to manipulate ripening, trimming, mal food. washing, or waxing. For farms and Preventive controls means those risk- farm mixed-type facilities, manufac- based, reasonably appropriate proce- turing/processing does not include ac- dures, practices, and processes that a tivities that are part of harvesting, person knowledgeable about the safe packing, or holding. manufacturing, processing, packing, or Microorganisms means yeasts, molds, holding of animal food would employ bacteria, viruses, protozoa, and micro- to significantly minimize or prevent scopic parasites and includes species the hazards identified under the hazard that are pathogens. The term ‘‘unde- analysis that are consistent with the sirable microorganisms’’ includes those current scientific understanding of safe microorganisms that are pathogens, food manufacturing, processing, pack- that subject animal food to decomposi- ing, or holding at the time of the anal- tion, that indicate that animal food is ysis.

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Preventive controls qualified individual of the food sold by such facility to all means a qualified individual who has other purchasers; and successfully completed training in the (2) The average annual monetary development and application of risk- value of all food sold during the 3-year based preventive controls at least period preceding the applicable cal- equivalent to that received under a endar year was less than $500,000, ad- standardized curriculum recognized as justed for inflation. adequate by FDA, or is otherwise Qualified facility exemption means an qualified through job experience to de- exemption applicable to a qualified fa- velop and apply a food safety system. cility under § 507.5(d). Qualified auditor means a person who Qualified individual means a person is a qualified individual as defined in who has the education, training, or ex- this part and has technical expertise perience (or a combination thereof) obtained through education, training, necessary to manufacture, process, or experience (or the combination pack, or hold safe animal food as ap- thereof) necessary to perform the au- propriate to the individual’s assigned diting function. Examples of potential duties. A qualified individual may be, qualified auditors include: but is not required to be, an employee (1) A government employee, includ- of the establishment. ing a foreign government employee; Raw agricultural commodity has the and meaning given in section 201(r) of the (2) An audit agent of a certification Federal Food, Drug, and Cosmetic Act. body that is accredited in accordance Receiving facility means a facility with regulations in part 1, subpart M of that is subject to subparts C and E of this chapter. this part and that manufactures/proc- Qualified end-user, with respect to esses a raw material or other ingre- food, means the consumer of the food dient that it receives from a supplier. (where the term consumer does not in- means clean, unadulterated clude a business); or a restaurant or re- Rework tail food establishment (as those terms animal food that has been removed are defined in § 1.227 of this chapter) from processing for reasons other than that: insanitary conditions or that has been successfully reconditioned by reproc- (1) Is located: essing and that is suitable for use as (i) In the same State or the same In- animal food. dian reservation as the qualified facility that sold the food to such res- Sanitize means to adequately treat taurant or retail food establishment; or cleaned surfaces by a process that is effective in destroying vegetative cells of (ii) Not more than 275 miles from such facility; and pathogens, and in substantially reducing numbers of other undesirable (2) Is purchasing the food for sale di- microorganisms, but without adversely rectly to consumers at such restaurant affecting the product or its safety for or retail food establishment. animals or humans. Qualified facility means (when including the sales by any subsidiary; affil- Significantly minimize means to reduce iate; or subsidiaries or affiliates, col- to an acceptable level, including to lectively, of any entity of which the fa- eliminate. cility is a subsidiary or affiliate) a fa- Small business means, for purposes of cility that is a very small business as this part, a business (including any defined in this part, or a facility to subsidiaries and affiliates) employing which both of the following apply: fewer than 500 full-time equivalent em- (1) During the 3-year period preceding ployees. the applicable calendar year, the aver- Subsidiary means any company which age annual monetary value of the food is owned or controlled directly or indi- manufactured, processed, packed, or rectly by another company. held at such facility that is sold di- Supplier means the establishment rectly to qualified end-users (as defined that manufactures/processes the ani- in this part) during such period exceed- mal food, raises the animal, or grows ed the average annual monetary value the food that is provided to a receiving

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facility without further manufac- You means, for purposes of this part, turing/processing by another establish- the owner, operator, or agent in charge ment, except for further manufac- of a facility. turing/processing that consists solely of the addition of labeling or similar [80 FR 56337, Sept. 17, 2015, as amended at 81 FR 3717, Jan. 22, 2016] activity of a de minimis nature. Supply-chain-applied control means a § 507.4 Qualifications of individuals preventive control for a hazard in a who manufacture, process, pack, or raw material or other ingredient when hold animal food. the hazard in the raw material or other (a)(1) The management of an estab- ingredient is controlled before its re- lishment must ensure that all individ- ceipt. uals who manufacture, process, pack, Unexposed packaged animal food or hold animal food subject to subparts means packaged animal food that is not exposed to the environment. B and F of this part are qualified to perform their assigned duties; and Validation means obtaining and evaluating scientific and technical evi- (2) The owner, operator, or agent in dence that a control measure, combina- charge of a facility must ensure that tion of control measures, or the food all individuals who manufacture, proc- safety plan as a whole, when properly ess, pack, or hold animal food subject implemented, is capable of effectively to subparts C, D, E, or F of this part controlling the identified hazards. are qualified to perform their assigned Verification means the application of duties. methods, procedures, tests and other (b) Each individual engaged in manu- evaluations, in addition to monitoring, facturing, processing, packing, or hold- to determine whether a control meas- ing animal food (including temporary ure or combination of control measures and seasonal personnel) or in the super- is or has been operating as intended vision thereof must: and to establish the validity of the food (1) Be a qualified individual as that safety plan. term is defined in § 507.3, i.e., have the Very small business means, for pur- education, training, or experience (or a poses of this part, a business (including combination thereof) necessary to any subsidiaries and affiliates) aver- manufacture, process, pack, or hold aging less than $2,500,000, adjusted for safe animal food as appropriate to the inflation, per year, during the 3-year individual’s assigned duties; and period preceding the applicable cal- (2) Receive training in the principles endar year in sales of animal food plus of animal food hygiene and animal food the market value of animal food manu- safety, including the importance of em- factured, processed, packed, or held ployee health and personal hygiene, as without sale (e.g., held for a fee or sup- appropriate to the animal food, the fa- plied to a farm without sale). cility and the individual’s assigned du- Water activity (aw) means a measure ties. of the free moisture in an animal food (c) Responsibility for ensuring com- and is the quotient of the water vapor pliance by individuals with the require- pressure of the substance divided by ments of this part must be clearly as- the vapor pressure of pure water at the same temperature. signed to supervisory personnel who have the education, training, or experi- Written procedures for receiving raw materials and other ingredients means ence (or a combination thereof) nec- written procedures to ensure that raw essary to supervise the production of materials and other ingredients are re- safe animal food. ceived only from suppliers approved by (d) Records that document training the receiving facility (or, when nec- required by paragraph (b)(2) of this sec- essary and appropriate, on a temporary tion must be established and main- basis from unapproved suppliers whose tained and are subject to the record- raw materials or other ingredients are keeping requirements in subpart F of subjected to adequate verification ac- this part. tivities before acceptance for use).

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§ 507.5 Exemptions. meal, grits, groats, hominy feed, malt (a) This part does not apply to estab- sprouts, middlings, pearled grain, pol- lishments, including ‘‘farms’’ (as de- ished grain, brewers grain, distillers fined in § 1.227 of this chapter), that are grain, and gluten meal); not required to register under section (4) Oilseed products (e.g., oil and meal 415 of the Federal Food, Drug, and Cos- of safflower, soybean, or sunflower); metic Act. (5) Molasses (e.g., processed sugar (b)(1) Subparts C and E of this part cane, sugar beets, and citrus); do not apply with respect to activities (6) Animal protein meals (e.g., blood, that are subject to § 500.23 and part 113 feather, meat, meat and bone, and ma- of this chapter (Thermally Processed rine (e.g., crab, fish, shrimp)); Low-Acid Foods Packaged in Hermeti- (7) Milk products (e.g., casein, cheese cally Sealed Containers) at an animal rind, and lactalbumin); food facility if you are required to (8) Animal tissue-derived products comply with, and are in compliance (e.g., fat); with, part 113 of this chapter with re- (9) Vitamins, minerals, and con- spect to those activities. centrates; (2) The exemption in paragraph (b)(1) (10) Processing aids (e.g., enzymes, of this section is applicable only with preservatives, and stabilizers); and respect to those microbiological haz- (11) Any other processed animal food ards regulated under part 113 of this that does not require time/temperature chapter. control for safety. (c) Subparts C and E of this part do (f) For a farm mixed-type facility not apply to activities of a facility that are subject to section 419 of the Federal that is a small or very small business, Food, Drug, and Cosmetic Act (Stand- subparts C and E of this part do not ards for Produce Safety). apply to on-farm manufacturing/proc- (d) Except as provided in subpart D of essing activities conducted by a small this part, subparts C and E of this part or very small business for distribution do not apply to a qualified facility. into commerce, and § 507.7 does not Qualified facilities are subject to the apply to on-farm manufacturing/proc- requirements in § 507.7. essing activities conducted by a very (e) For a farm mixed-type facility small business for distribution into that is a small or very small business, commerce, if the only manufacturing/ subparts C and E of this part do not processing activities subject to section apply to on-farm packing or holding of 418 of the Federal Food, Drug, and Cos- processed animal food, and § 507.7 does metic Act that the business conducts not apply to on-farm packing or hold- consists of the following low-risk man- ing of processed animal food by a very ufacturing/processing activity/animal small business, if the only packing or food combinations: holding activities subject to section 418 (1) Chopping or shredding hay; of the Federal Food, Drug, and Cos- (2) Cracking, crimping, flaking, metic Act that the business conducts pearling, peeling, shelling, or are the following low-risk packing or wafering—grain (e.g., barley, sorghum, holding activity/animal food combina- corn, oats, rice, rye, and wheat) or oil- tions—i.e., packing (or repacking) (in- seed (e.g., beans, canola, cottonseed, cluding weighing or conveying inci- linseed, soybeans, and sunflowers); dental to packing or repacking); sort- (3) Crushing, dry rolling, grinding, ing, culling, or grading incidental to milling, pulverizing—grain, oilseed, packing or storing; and storing (ambi- grain by-products and processed grain ent, cold and controlled atmosphere) products, oilseed products, hay, ensiled of: material, culled fruits and vegetables, (1) Roughage products (e.g., alfalfa roughage (e.g., cobs, hulls, husks, and meal, entire plant meal, stem meal, straws), or roughage products; pomace, and pulp); (4) Ensiling (including chopping, (2) Plant protein meals (e.g., algae, shredding, mixing, storing, or fer- coconut (copra), guar, and peanut); menting), that is, making silage or (3) Grain by-products and processed haylage from forage (e.g., sorghum grain products (e.g., bran, flour, germ (milo), corn (maize), alfalfa, and grass),

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grain, culled fruits and vegetables, or (1) An attestation that the facility is roughage; a qualified facility as defined in § 507.3. (5) Extracting (mechanical) or wet For the purpose of determining wheth- rolling grain, oilseed, brewers grain by- er a facility satisfies the definition of products, or distillers grain by-prod- qualified facility, the baseline year for ucts; calculating the adjustment for infla- (6) Labeling roughage products, plant tion is 2011; and protein meals, grain by-products and (2)(i) An attestation that you have processed grain products, oilseed prod- identified the potential hazards associ- ucts, molasses, animal protein meals, ated with the animal food being pro- milk products, animal tissue-derived duced, are implementing preventive products, vitamins, minerals, con- controls to address the hazards, and centrates, processing aids, finished ani- are monitoring the performance of the mal food, including animal food ready preventive controls to ensure that such for consumption, or any other proc- controls are effective; or essed animal food that does not require time/temperature control for safety; (ii) An attestation that the facility is and in compliance with State, local, coun- (7) Packaging roughage products, ty, tribal, or other applicable non-Fed- plant protein meals, grain by-products eral food safety law, including relevant and processed grain products, oilseed laws and regulations of foreign coun- products, molasses, animal protein tries, including an attestation based on meals, milk products, animal tissue-de- licenses, inspection reports, certifi- rived products, vitamins, minerals, cates, permits, credentials, certifi- concentrates, processing aids, finished cation by an appropriate agency (such animal food, including animal food as a State department of agriculture), ready for consumption, or any other or other evidence of oversight. processed animal food that does not re- (b) The attestations required by para- quire time/temperature control for graph (a) of this section must be sub- safety. mitted to FDA by any one of the fol- (g) Subparts C and E of this part do lowing means: not apply to facilities that are solely (1) Electronic submission. To submit engaged in the storage of raw agricul- electronically, go to http://www.fda.gov/ tural commodities (other than fruits furls and follow the instructions. This and vegetables) intended for further Web site is available from wherever the distribution or processing. Internet is accessible, including librar- (h) Subpart B of this part does not ies, copy centers, schools, and Internet apply to any of the following: cafes. FDA encourages electronic sub- (1) Establishments solely engaged in mission. the holding and/or transportation of (2) Submission by mail. (i) You must one or more raw agricultural commodities; use Form FDA 3942b. You may obtain a copy of this form by any of the fol- (2) Establishments solely engaged in hulling, shelling, drying, packing, and/ lowing mechanisms: or holding nuts and hulls (without (A) Download it from http:// manufacturing/processing, such as www.fda.gov/pcafrule; grinding shells or roasting nuts); and (B) Write to the U.S. Food and Drug (3) Establishments solely engaged in Administration (HFS–681), 5001 Campus ginning of cotton (without manufac- Dr., College Park, MD 20740; or turing/processing, such as extracting (C) Request a copy of this form by oil from cottonseed). phone at 1–800–216–7331 or 301–575–0156. (ii) Send a paper Form FDA 3942b to [80 FR 56337, Sept. 17, 2015, as amended at 81 FR 3717, Jan. 22, 2016] the U.S. Food and Drug Administration (HFS–681), 5001 Campus Dr., College § 507.7 Requirements that apply to a Park, MD 20740. We recommend that qualified facility. you submit a paper copy only if your (a) A qualified facility must submit facility does not have reasonable ac- the following attestations to FDA: cess to the Internet.

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(c)(1) A facility must determine and (2) If an animal food packaging label document its status as a qualified fa- is not required, the notification re- cility on an annual basis no later than quired by paragraph (e) of this section July 1 of each calendar year. must appear prominently and conspicu- (2) The attestations required by para- ously, at the point of purchase, on a graph (a) of this section must be: label, poster, sign, placard, or docu- (i) Submitted to FDA initially: ments delivered contemporaneously (A) By December 16, 2019 for a facility with the animal food in the normal that begins manufacturing, processing, course of business, or in an electronic packing, or holding animal food before notice, in the case of Internet sales. September 17, 2019; (f)(1) A qualified facility must main- (B) Before beginning operations, for a tain those records relied upon to sup- facility that begins manufacturing, port the attestations that are required processing, packing, or holding animal by paragraph (a) of this section. food after September 17, 2019; or (2) The records that a qualified facil- (C) By July 31 of the applicable cal- ity must maintain are subject to the endar year, when the status of a facil- requirements of subpart F of this part. ity changes from ‘‘not a qualified facil- [80 FR 56337, Sept. 17, 2015, as amended at 81 ity’’ to ‘‘qualified facility’’ based on FR 3717, Jan. 22, 2016; 81 FR 49897, July 29, the annual determination required by 2016] paragraph (c)(1) of this section; and (ii) Beginning in 2020, submitted to § 507.10 Applicability of subparts C FDA every 2 years during the period and E of this part to a facility solely beginning on October 1 and ending on engaged in the storage of unex- December 31. posed packaged animal food. (3) When the status of a facility (a) Subparts C and E of this part do changes from ‘‘qualified facility’’ to not apply to a facility solely engaged ‘‘not a qualified facility’’ based on the in the storage of unexposed packaged annual determination required by para- animal food that does not require time/ graph (c)(1) of this section, the facility temperature control to significantly must notify FDA of that change in sta- minimize or prevent the growth of, or tus using Form FDA 3942b by July 31 of toxin production by, pathogens. the applicable calendar year. (b) A facility solely engaged in the (d) When the status of a facility storage of unexposed packaged animal changes from ‘‘qualified facility’’ to food, including unexposed packaged ‘‘not a qualified facility,’’ the facility animal food that requires time/tem- must comply with subparts C and E of perature control to significantly mini- this part no later than December 31 of mize or prevent the growth of, or toxin the applicable calendar year unless production by, pathogens is subject to otherwise agreed to by FDA and the fa- the modified requirements in § 507.51 cility. for any unexposed packaged animal (e) A qualified facility that does not food that requires time/temperature submit attestations under paragraph control to significantly minimize or (a)(2)(i) of this section must provide prevent the growth of, or toxin produc- notification to consumers as to the tion by, pathogens. name and complete business address of the facility where the animal food was § 507.12 Applicability of this part to manufactured or processed (including the holding and distribution of the street address or P.O. Box, city, human food by-products for use as state, and zip code for domestic facili- animal food. ties, and comparable full address infor- (a) Except as provided by paragraph mation for foreign facilities) as fol- (b) of this section, the requirements of lows: this part do not apply to by-products of (1) If an animal food packaging label human food production, or the off-farm is required, the notification required packing and holding of raw agricul- by paragraph (e) of this section must tural commodities, that are packed or appear prominently and conspicuously held by that human food facility for on the label of the animal food. distribution as animal food if:

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(1)(i) The human food facility is sub- tamination of animal food, animal ject to and in compliance with subpart food-contact surfaces, or animal food- B of part 117 of this chapter and in packaging materials. compliance with all applicable human food safety requirements of the Federal § 507.17 Plant and grounds. Food, Drug, and Cosmetic Act and im- (a) The grounds around an animal plementing regulations; or food plant under the control of the (ii) For the off-farm packing and management of the establishment holding of produce (as defined in part must be kept in a condition that will 112 of this chapter), the human food fa- protect against the contamination of cility is subject to and in compliance animal food. Maintenance of grounds with § 117.8 of this chapter and in com- must include: pliance with all applicable human food (1) Properly storing equipment, re- safety requirements of the Federal moving litter and waste, and cutting Food, Drug, and Cosmetic Act and im- weeds or grass within the immediate plementing regulations; and vicinity of the plant that may con- (2) The human food facility does not stitute an attractant, breeding place, further manufacture or process the by- or harborage for pests; products intended for use as animal (2) Maintaining driveways, yards, and food. parking areas so that they do not con- (b) The human food by-products for stitute a source of contamination in use as animal food identified in para- areas where animal food is exposed; graph (a) of this section must be held (3) Adequately draining areas that and distributed by that facility in ac- may contribute to contamination of cordance with §§ 507.28 and 117.95 of this animal food; and chapter. (4) Treating and disposing of waste so that it does not constitute a source of Subpart B—Current Good contamination in areas where animal Manufacturing Practice food is exposed. (b) The plant must be suitable in size, § 507.14 Personnel. construction, and design to facilitate (a) The management of the establish- cleaning, maintenance, and pest con- ment must take reasonable measures trol to reduce the potential for con- and precautions to ensure that all per- tamination of animal food, animal sons working in direct contact with food-contact surfaces, and animal food- animal food, animal food-contact sur- packaging materials, including that faces, and animal food-packaging ma- the plant must: terials conform to hygienic practices (1) Provide adequate space between to the extent necessary to protect equipment, walls, and stored materials against the contamination of animal to permit employees to perform their food. duties and to allow cleaning and main- (b) The methods for conforming to tenance of equipment; hygienic practices and maintaining (2) Be constructed in a manner such cleanliness include: that drip or condensate from fixtures, (1) Maintaining adequate personal ducts, and pipes does not serve as a cleanliness; source of contamination; (2) Washing hands thoroughly in an (3) Provide adequate ventilation (me- adequate hand-washing facility as nec- chanical or natural) where necessary essary and appropriate to protect and appropriate to minimize vapors against contamination; (e.g., steam) and fumes in areas where (3) Removing or securing jewelry and they may contaminate animal food and other objects that might fall into ani- in a manner that minimizes the poten- mal food, equipment, or containers; tial for contaminating animal food; (4) Storing clothing or other personal (4) Provide adequate lighting in belongings in areas other than where hand-washing areas, toilet rooms, animal food is exposed or where equip- areas where animal food is received, ment or utensils are cleaned; and manufactured, processed, packed, or (5) Taking any other necessary pre- held, and areas where equipment or cautions to protect against the con- utensils are cleaned; and

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(5) Provide shatter-resistant light where animal food is manufactured, bulbs, fixtures, and skylights, or other processed, or exposed: glass items suspended over exposed ani- (i) Those required to maintain clean mal food in any step of preparation, to and sanitary conditions; protect against the contamination of (ii) Those necessary for use in labora- animal food in case of glass breakage. tory testing procedures; (c) The plant must protect animal (iii) Those necessary for plant and food stored outdoors in bulk from con- equipment maintenance and operation; tamination by any effective means, in- and cluding: (iv) Those necessary for use in the (1) Using protective coverings where plant’s operations. necessary and appropriate; (2) Toxic materials described in para- (2) Controlling areas over and around graph (d)(1) of this section (e.g., clean- the bulk animal food to eliminate ing compounds, sanitizing agents, and harborages for pests; and pesticide chemicals) must be identified, (3) Checking on a regular basis for used, and stored in a manner that pro- pests, pest infestation, and product tects against the contamination of ani- condition related to safety of the animal food, animal food-contact surfaces, mal food. or animal food-packaging materials; and § 507.19 Sanitation. (3) Other toxic materials (such as fer- (a) Buildings, structures, fixtures, tilizers and pesticides not included in and other physical facilities of the paragraph (d)(1) of this section) must plant must be kept clean and in good be stored in an area of the plant where repair to prevent animal food from be- animal food is not manufactured, proc- coming adulterated. essed, or exposed. (b) Animal food-contact and non-con- (e) Effective measures must be taken tact surfaces of utensils and equipment to exclude pests from the manufac- must be cleaned and maintained and turing, processing, packing, and hold- utensils and equipment stored as nec- ing areas and to protect against the essary to protect against the contami- contamination of animal food by pests. nation of animal food, animal food-con- The use of pesticides in the plant is tact surfaces, or animal food-pack- permitted only under precautions and aging materials. When necessary, restrictions that will protect against equipment must be disassembled for the contamination of animal food, ani- thorough cleaning. In addition: mal food-contact surfaces, and animal (1) When animal food-contact sur- food-packaging materials. faces used for manufacturing, proc- (f) Trash must be conveyed, stored, essing, packing, or holding animal food and disposed of in a way that protects are wet-cleaned, the surfaces must, against the contamination of animal when necessary, be thoroughly dried food, animal food-contact surfaces, ani- before subsequent use; and mal food-packaging materials, water (2) In wet processing of animal food, supplies, and ground surfaces, and when cleaning and sanitizing are nec- minimizes the potential for the trash essary to protect against the introduc- to become an attractant and harborage tion of undesirable microorganisms or breeding place for pests. into animal food, all animal food-con- [80 FR 56337, Sept. 17, 2015, as amended at 81 tact surfaces must be cleaned and sani- FR 3717, Jan. 22, 2016] tized before use and after any interruption during which the animal food-con- § 507.20 Water supply and plumbing. tact surfaces may have become con- (a) The following apply to the water taminated. supply: (c) Cleaning compounds and sani- (1) Water must be adequate for the tizing agents must be safe and ade- operations and must be derived from an quate under the conditions of use. adequate source; (d) The following applies to toxic ma- (2) Running water at a suitable tem- terials: perature, and under suitable pressure (1) Only the following toxic materials as needed, must be provided in all areas may be used or stored in the plant area where required for the manufacturing,

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processing, packing, or holding of ani- (1) All plant equipment and utensils, mal food, for the cleaning of equip- including equipment and utensils that ment, utensils, and animal food-pack- do not come in contact with animal aging materials, or for employee hand- food, must be designed and constructed washing facilities; of such material and workmanship to (3) Water that contacts animal food, be adequately cleanable, and must be animal food-contact surfaces, or ani- properly maintained; mal food-packaging materials must be (2) Equipment and utensils must be safe for its intended use; and designed, constructed, and used appro- (4) Water may be reused for washing, priately to avoid the adulteration of rinsing, or conveying animal food if it animal food with non-food grade lubri- does not increase the level of contami- cants, fuel, metal fragments, contamination of the animal food. nated water, or any other contami- (b) Plumbing must be designed, in- nants; stalled, and maintained to: (3) Equipment must be installed so as (1) Carry adequate quantities of to facilitate the cleaning and mainte- water to required locations throughout nance of the equipment and adjacent the plant; spaces; (2) Properly convey sewage and liquid (4) Animal food-contact surfaces disposable waste from the plant; must be: (i) Made of materials that withstand (3) Avoid being a source of contami- the environment of their use and the nation to animal food, water supplies, action of animal food, and, if applica- equipment, or utensils, or creating an ble, the action of cleaning compounds, unsanitary condition; cleaning procedures, and sanitizing (4) Provide adequate floor drainage in agents; all areas where floors are subject to (ii) Made of nontoxic materials; and flooding-type cleaning or where normal (iii) Maintained to protect animal operations release or discharge water food from being contaminated. or other liquid waste on the floor; and (b) Holding, conveying, manufac- (5) Ensure that there is no backflow turing, and processing systems, includ- from, or cross-connection between, piping gravimetric, pneumatic, closed, ing systems that discharge waste water and automated systems, must be de- or sewage and piping systems that signed, constructed, and maintained in carry water for animal food or animal a way to protect against the contami- food manufacturing. nation of animal food. (c) Sewage and liquid disposal waste (c) Each freezer and cold storage must be disposed of through an ade- compartment used to hold animal food quate sewerage system or through must be fitted with an accurate tem- other adequate means. perature-measuring device. (d) Each plant must provide employ- (d) Instruments and controls used for ees with adequate, readily accessible measuring, regulating, or recording toilet facilities. Toilet facilities must temperatures, pH, aw, or other condi- be kept clean and must not be a poten- tions that control or prevent the tial source of contamination of animal growth of undesirable microorganisms food, animal food-contact surfaces, or in animal food must be accurate, pre- animal food-packaging materials. cise, adequately maintained, and ade- (e) Each plant must provide hand- quate in number for their designated washing facilities designed to ensure uses. that an employee’s hands are not a po- (e) Compressed air or other gases me- tential source of contamination of ani- chanically introduced into animal food mal food, animal food-contact surfaces, or used to clean animal food-contact or animal food-packaging materials. surfaces or equipment must be used in such a way to protect against the con- § 507.22 Equipment and utensils. tamination of animal food. (a) The following apply to plant equipment and utensils used in manu- § 507.25 Plant operations. facturing, processing, packing, and (a) Management of the establishment holding animal food: must ensure that:

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(1) All operations in the manufac- (iii) Raw materials and other ingredi- turing, processing, packing, and hold- ents, including rework, must be stored ing of animal food (including oper- in containers designed and constructed ations directed to receiving, inspect- in a way that protects against con- ing, transporting, and segregating) are tamination and deterioration, and held conducted in accordance with the cur- under conditions, e.g., appropriate tem- rent good manufacturing practice re- perature and relative humidity, that quirements of this subpart; will minimize the potential for growth (2) Animal food, including raw mate- of undesirable microorganisms and pre- rials, other ingredients, or rework is vent the animal food from becoming accurately identified; adulterated; (3) Animal food-packaging materials (2) Susceptible to contamination are safe and suitable; with mycotoxins or other natural tox- (4) The overall cleanliness of the ins must be evaluated and used in a plant is under the supervision of one or manner that does not result in animal more competent individuals assigned food that can cause injury or illness to responsibility for this function; animals or humans; and (5) Adequate precautions are taken so (3) If frozen, must be kept frozen. If that plant operations do not contribute thawing is required prior to use, it to contamination of animal food, ani- must be done in a manner that minimal food-contact surfaces, and animal mizes the potential for the growth of food-packaging materials; undesirable microorganisms. (6) Chemical, microbial, or extra- (c) For the purposes of manufac- neous-material testing procedures are turing, processing, packing, and hold- used where necessary to identify sani- ing operations, the following apply: tation failures or possible animal food (1) Animal food must be maintained contamination; under conditions, e.g., appropriate tem- (7) Animal food that has become perature and relative humidity, that adulterated is rejected, disposed of, or will minimize the potential for growth if appropriate, treated or processed to of undesirable microorganisms and pre- eliminate the adulteration. If disposed vent the animal food from becoming of, it must be done in a manner that adulterated during manufacturing, protects against the contamination of processing, packing, and holding; other animal food; and (2) Measures taken during manufac- (8) All animal food manufacturing, turing, processing, packing, and hold- processing, packing, and holding is ing of animal food to significantly min- conducted under such conditions and imize or prevent the growth of undesir- controls as are necessary to minimize able microorganisms (e.g., heat treat- the potential for the growth of undesir- ing, freezing, refrigerating, irradiating, able microorganisms to protect against controlling pH, or controlling aw) must the contamination of animal food. be adequate to prevent adulteration of (b) Raw materials and other ingredi- animal food; ents: (3) Work-in-process and rework must (1) Must be examined to ensure that be handled in such a way that it is pro- they are suitable for manufacturing tected against contamination and the and processing into animal food and growth of undesirable microorganisms; must be handled under conditions that (4) Steps such as cutting, drying, will protect against contamination and defatting, grinding, mixing, extruding, minimize deterioration. In addition: pelleting, and cooling, must be per- (i) Shipping containers (e.g., totes, formed in a way that protects against drums, and tubs) and bulk vehicles the contamination of animal food; holding raw materials and other ingre- (5) Filling, assembling, packaging, dients must be examined upon receipt and other operations must be per- to determine whether contamination formed in such a way that protects or deterioration of animal food has oc- against the contamination of animal curred; food and the growth of undesirable (ii) Raw materials must be cleaned as microorganisms; necessary to minimize contamination; (6) Animal food that relies prin- and cipally on the control of water activity

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(aw) for preventing the growth of unde- result in unsafe cross contamination sirable microorganisms must be proc- with other animal food. essed to and maintained at a safe aw [80 FR 56337, Sept. 17, 2015, as amended at 81 level; FR 3717, Jan. 22, 2016] (7) Animal food that relies principally on the control of pH for pre- § 507.28 Holding and distribution of venting the growth of undesirable human food by-products for use as microorganisms must be monitored animal food. and maintained at the appropriate pH; (a) Human food by-products held for and distribution as animal food must be (8) When ice is used in contact with held under conditions that will protect animal food, it must be made from against contamination, including the water that is safe and must be used following: only if it has been manufactured in ac- (1) Containers and equipment used to cordance with current good manufac- convey or hold human food by-products turing practice as outlined in this sub- for use as animal food before distribution must be designed, constructed of part. appropriate material, cleaned as nec- § 507.27 Holding and distribution. essary, and maintained to protect against the contamination of human (a) Animal food held for distribution food by-products for use as animal must be held under conditions that will food; protect against contamination and (2) Human food by-products for use as minimize deterioration, including the animal food held for distribution must following: be held in a way to protect against con- (1) Containers used to hold animal tamination from sources such as trash; food before distribution must be de- and signed, constructed of appropriate ma- (3) During holding, human food by- terial, cleaned as necessary, and main- products for use as animal food must tained to protect against the contami- be accurately identified. nation of animal food; and (b) Labeling that identifies the prod- (2) Animal food held for distribution uct by the common or usual name must be held in a way that protects must be affixed to or accompany the against contamination from sources human food by-products for use as animal food when distributed. such as trash. (c) Shipping containers (e.g., totes, (b) The labeling for the animal food drums, and tubs) and bulk vehicles ready for distribution must contain, used to distribute human food by-prod- when applicable, information and in- ucts for use as animal food must be ex- structions for safely using the animal amined prior to use to protect against food for the intended animal species. the contamination of animal food from (c) Shipping containers (e.g., totes, the container or vehicle when the facil- drums, and tubs) and bulk vehicles ity is responsible for transporting the used to distribute animal food must be human food by-products for use as ani- examined prior to use to protect mal food itself or arranges with a third against the contamination of animal party to transport the human food by- food from the container or vehicle products for use as animal food. when the facility is responsible for transporting the animal food itself or Subpart C—Hazard Analysis and arranges with a third party to trans- Risk-Based Preventive Controls port the animal food. (d) Animal food returned from dis- § 507.31 Food safety plan. tribution must be assessed for animal (a) You must prepare, or have pre- food safety to determine the appro- pared, and implement a written food priate disposition. Returned animal safety plan. food must be identified as such and seg- (b) One or more preventive controls regated until assessed. qualified individuals must prepare, or (e) Unpackaged or bulk animal food oversee the preparation of, the food must be held in a manner that does not safety plan.

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(c) The written food safety plan must (i) The hazard occurs naturally; include: (ii) The hazard may be unintention- (1) The written hazard analysis as re- ally introduced; or quired by § 507.33(a)(2); (iii) The hazard may be intentionally (2) The written preventive controls as introduced for purposes of economic required by § 507.34(b); gain. (3) The written supply-chain program (c)(1) The hazard analysis must in- as required by subpart E of this part; clude an evaluation of the hazards (4) The written recall plan as re- identified in paragraph (b) of this sec- quired by § 507.38(a)(1); tion to assess the severity of the illness (5) The written procedures for moni- or injury to humans or animals if the toring the implementation of the pre- hazard were to occur and the prob- ventive controls as required by ability that the hazard will occur in § 507.40(a)(1); the absence of preventive controls. (6) The written corrective action pro- (2) The hazard evaluation required by cedures as required by § 507.42(a)(1); and paragraph (c)(1) of this section must in- (7) The written verification proce- clude an evaluation of environmental dures as required by § 507.49(b). pathogens whenever an animal food is (d) The food safety plan required by exposed to the environment prior to this section is a record that is subject packaging and the packaged animal to the requirements of subpart F of food does not receive a treatment or this part. otherwise include a control measure (such as a formulation lethal to the § 507.33 Hazard analysis. pathogen) that would significantly (a)(1) You must conduct a hazard minimize the pathogen. analysis to identify and evaluate, based (d) The hazard evaluation must con- on experience, illness data, scientific sider the effect of the following on the reports, and other information, known safety of the finished animal food for or reasonably foreseeable hazards for the intended animal: each type of animal food manufac- (1) The formulation of the animal tured, processed, packed, or held at food; your facility to determine whether (2) The condition, function, and de- there are any hazards requiring a pre- sign of the facility and equipment; ventive control; and (3) Raw materials and other ingredi- (2) The hazard analysis must be writ- ents; ten regardless of its outcome. (4) Transportation practices; (b) The hazard identification must (5) Manufacturing/processing proce- consider: dures; (1) Known or reasonably foreseeable (6) Packaging activities and labeling hazards that include: activities; (i) Biological hazards, including (7) Storage and distribution; microbiological hazards such as (8) Intended or reasonably foresee- parasites, environmental pathogens, able use; and other pathogens; (9) Sanitation, including employee (ii) Chemical hazards, including radi- hygiene; and ological hazards, substances such as (10) Any other relevant factors such pesticide and drug residues, natural as the temporal (e.g., weather-related) toxins, decomposition, unapproved food nature of some hazards (e.g., levels of or color additives, and nutrient defi- some natural toxins). ciencies or toxicities (such as inad- [80 FR 56337, Sept. 17, 2015, as amended at 81 equate thiamine in cat food, excessive FR 3717, Jan. 22, 2016] vitamin D in dog food, and excessive copper in food for sheep); and § 507.34 Preventive controls. (iii) Physical hazards (such as stones, (a)(1) You must identify and imple- glass, and metal fragments); and ment preventive controls to provide as- (2) Known or reasonably foreseeable surances that any hazards requiring a hazards that may be present in the ani- preventive control will be significantly mal food for any of the following rea- minimized or prevented and the animal sons: food manufactured, processed, packed,

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or held by your facility will not be (4) A recall plan as required by adulterated under section 402 of the § 507.38; and Federal Food, Drug, and Cosmetic Act; (5) Other preventive controls. These and include any other procedures, prac- (2) Preventive controls required by tices, and processes necessary to sat- paragraph (a)(1) of this section include: isfy the requirements of paragraph (a) (i) Controls at critical control points of this section. Examples of other con- (CCPs), if there are any CCPs; and trols include hygiene training and (ii) Controls, other than those at other current good manufacturing CCPs, that are also appropriate for ani- practices. mal food safety. (b) Preventive controls must be writ- § 507.36 Circumstances in which the ten. owner, operator, or agent in charge (c) Preventive controls include, as of a manufacturing/processing facil- appropriate to the facility and animal ity is not required to implement a preventive control. food: (1) Process controls. Process controls (a) If you are a manufacturer/proc- include procedures, practices, and processor, you are not required to imple- esses to ensure the control of param- ment a preventive control when you eters during operations such as heat identify a hazard requiring a preven- processing, irradiating, and refrig- tive control (identified hazard) and any erating animal food. Process controls of the following circumstances apply: must include, as appropriate to the na- (1) You determine and document that ture of the applicable control and its the type of animal food could not be role in the facility’s food safety sys- consumed without application of an ap- tem: propriate control; (i) Parameters associated with the (2) You rely on your customer who is control of the hazard; and subject to the requirements for hazard (ii) The maximum or minimum analysis and risk-based preventive con- value, or combination of values, to trols in this subpart to ensure that the which any biological, chemical, or identified hazard will be significantly physical parameter must be controlled minimized or prevented; and you: to significantly minimize or prevent a (i) Disclose in documents accom- hazard requiring a process control. panying the animal food, in accordance (2) Sanitation controls. Sanitation with the practice of the trade, that the controls include procedures, practices, animal food is ‘‘not processed to con- and processes to ensure that the facil- trol [identified hazard]’’; and ity is maintained in a sanitary condi- (ii) Annually obtain from your cus- tion adequate to significantly mini- tomer written assurance, subject to the mize or prevent hazards such as envi- requirements of § 507.37, that the cus- ronmental pathogens and biological tomer has established and is following hazards due to employee handling. procedures (identified in the written Sanitation controls must include, as assurance) that will significantly mini- appropriate to the facility and the ani- mize or prevent the identified hazard mal food, procedures, practices, and (except as provided in paragraph (c) of processes for the: this section); (i) Cleanliness of animal food-contact (3) You rely on your customer who is surfaces, including animal food-contact not subject to the requirements for surfaces of utensils and equipment; and hazard analysis and risk-based preven- (ii) Prevention of cross-contamina- tive controls in this subpart to provide tion from insanitary objects and from assurance it is manufacturing, proc- personnel to animal food, animal food- essing, or preparing the animal food in packaging material, and other animal accordance with applicable animal food food-contact surfaces and from raw safety requirements and you: product to processed product. (i) Disclose in documents accom- (3) Supply-chain controls. Supply- panying the animal food, in accordance chain controls include the supply-chain with the practice of the trade, that the program as required by subpart E of animal food is ‘‘not processed to con- this part; trol [identified hazard]’’; and

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(ii) Annually obtain from your cus- (1) A determination in accordance tomer written assurance that it is with paragraph (a) of this section that manufacturing, processing, or pre- the type of animal food could not be paring the animal food in accordance consumed without application of an ap- with applicable animal food safety re- propriate control; quirements; (2) The annual written assurance (4) You rely on your customer to pro- from your customer in accordance with vide assurance that the animal food paragraph (a)(2) of this section; will be processed to control the identi- (3) The annual written assurance fied hazard by an entity in the dis- from your customer in accordance with tribution chain subsequent to the cus- paragraph (a)(3) of this section; tomer and you: (4) The annual written assurance (i) Disclose in documents accom- from your customer in accordance with panying the animal food, in accordance paragraph (a)(4) of this section; and with the practice of the trade, that the (5) Your system, in accordance with animal food is ‘‘not processed to con- paragraph (a)(5) of this section, that trol [identified hazard]’’; and ensures control, at a subsequent dis- (ii) Annually obtain from your cus- tribution step, of the hazards in the tomer written assurance, subject to the animal food you distribute. requirements of § 507.37, that your cus- (c) For the written assurance re- tomer: quired by paragraph (a)(2)(ii) of this (A) Will disclose in documents ac- section, if your customer has deter- companying the animal food, in ac- mined that the identified hazard in cordance with the practice of the trade, paragraph (a) of this section is not a that the animal food is ‘‘not processed hazard in the animal food intended for to control [identified hazard]’’; and use for a specific animal species, your (B) Will only sell to another entity customer’s written assurance may pro- that agrees, in writing, it will: vide this determination (including ani- ( ) Follow procedures (identified in a 1 mal species and why the identified haz- written assurance) that will signifi- ard is not a hazard) instead of pro- cantly minimize or prevent the identi- viding assurance of procedures estab- fied hazard (if the entity is subject to lished and followed that will signifi- the requirements for hazard analysis cantly minimize or prevent the identi- and risk-based preventive controls in fied hazard. subpart C of this part), except as pro- (d) For the written assurance re- vided in paragraph (d) of this section, quired by paragraph (a)(4)(ii)(B) of this or manufacture, process, or prepare the section, if the entity in the distribu- animal food in accordance with appli- tion chain subsequent to your cus- cable animal food safety requirements tomer is subject to subpart C of this (if the entity is not subject to the re- part and has determined that the iden- quirements for hazard analysis and tified hazard in paragraph (a) of this risk-based preventive controls in sub- section is not a hazard in the animal part C of this part); or food intended for use for a specific ani- (2) Obtain a similar written assur- mal species, that entity’s written as- ance from the entity’s customer, sub- surance may provide this determina- ject to the requirements of § 507.37, as tion (including animal species and why in paragraphs (a)(4)(ii)(A) and (B) of the identified hazard is not a hazard) this section, as appropriate; or instead of providing assurance that the (5) You have established, docu- identified hazard will be significantly mented, and implemented a system minimized or prevented. that ensures control, at a subsequent distribution step, of the hazards in the [80 FR 56337, Sept. 17, 2015, as amended at 81 animal food you distribute and you FR 3717, Jan. 22, 2016] document the implementation of that system. § 507.37 Provision of assurances re- (b) You must document any cir- quired under § 507.36(a)(2), (3), and cumstance specified in paragraph (a) of (4). this section that applies to you, includ- A facility that provides a written as- ing: surance under § 507.36(a)(2), (3), or (4)

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must act consistently with the assur- trolled before receipt of the raw mate- ance and document its actions taken to rial or other ingredient: satisfy the written assurance. (1) Corrective actions and corrections in accordance with § 507.42, taking into § 507.38 Recall plan. account the nature of any supplier non- (a) For animal food with a hazard re- conformance; quiring a preventive control you must: (2) Review of records in accordance (1) Establish a written recall plan for with § 507.49(a)(4)(ii); and the animal food; and (3) Reanalysis in accordance with (2) Assign responsibility for per- § 507.50. forming all procedures in the recall (c) The recall plan established in plan. § 507.38 is not subject to the require- (b) The written recall plan must in- ments of paragraph (a) of this section. clude procedures that describe the steps to perform the following actions § 507.40 Monitoring. as appropriate to the facility: As appropriate to the nature of the (1) Directly notify direct consignees preventive control and its role in the about the animal food being recalled, facility’s food safety system you must: including how to return or dispose of (a) Establish and implement written the affected animal food; procedures, including the frequency (2) Notify the public about any haz- with which they are to be performed, ard presented by the animal food when for monitoring the preventive controls; appropriate to protect human and ani- and mal health; (b) Monitor the preventive controls (3) Conduct effectiveness checks to with adequate frequency to provide as- verify the recall has been carried out; surance that they are consistently per- and formed. (4) Appropriately dispose of recalled (c)(1) You must document the moni- animal food, e.g., through reprocessing, toring of preventive controls in accord- reworking, diverting to another use ance with this section in records that that would not present a safety con- are subject to verification in accord- cern, or destroying the animal food. ance with § 507.45(a)(2) and records review in accordance with § 507.49(a)(4)(i); § 507.39 Preventive control manage- (2)(i) Records of refrigeration tem- ment components. perature during storage of animal food (a) Except as provided by paragraphs that requires time/temperature control (b) and (c) of this section, the preven- to significantly minimize or prevent tive controls required under § 507.34 are the growth of, or toxin production by, subject to the following preventive pathogens may be affirmative records control management components as demonstrating temperature is con- appropriate to ensure the effectiveness trolled or exception records dem- of the preventive controls, taking into onstrating loss of temperature control; account the nature of the preventive and control and its role in the facility’s (ii) Exception records may be ade- food safety system: quate in circumstances other than (1) Monitoring in accordance with monitoring of refrigeration tempera- § 507.40; ture. (2) Corrective actions and corrections in accordance with § 507.42; and § 507.42 Corrective actions and correc- (3) Verification in accordance with tions. § 507.45. (a) As appropriate to the nature of (b) The supply-chain program estab- the hazard and the nature of the pre- lished in subpart E of this part is sub- ventive control, except as provided by ject to the following preventive control paragraph (c) of this section: management components as appro- (1) You must establish and imple- priate to ensure the effectiveness of the ment written corrective action proce- supply-chain program, taking into ac- dures that must be taken if preventive count the nature of the hazard con- controls are not properly implemented,

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including procedures to address, as ap- (iv) As necessary, prevent affected propriate: animal food from entering commerce (i) The presence of a pathogen or ap- as would be done following the correc- propriate indicator organism in animal tive action procedure under paragraph food detected as a result of product (a)(2) of this section; and testing conducted in accordance with (v) When appropriate, reanalyze the § 507.49(a)(2); and food safety plan in accordance with (ii) The presence of an environmental § 507.50 to determine whether modifica- pathogen or appropriate indicator or- tion of the food safety plan is required. ganism detected through the environ- (c) You do not need to comply with mental monitoring conducted in ac- the requirements of paragraphs (a) and cordance with § 507.49(a)(3). (2) The corrective action procedures (b) of this section if: must describe the steps to be taken to (1) You take action, in a timely man- ensure that: ner, to identify and correct conditions (i) Appropriate action is taken to and practices that are not consistent identify and correct a problem that has with the sanitation controls in occurred with implementation of a pre- § 507.34(c)(2)(i) or (ii); or ventive control; (2) You take action, in a timely man- (ii) Appropriate action is taken when ner, to identify and correct a minor necessary, to reduce the likelihood and isolated problem that does not di- that the problem will recur; rectly impact product safety. (iii) All affected animal food is evalu- (d) All corrective actions (and, when ated for safety; and appropriate, corrections) taken in ac- (iv) All affected animal food is pre- cordance with this section must be doc- vented from entering into commerce if umented in records. These records are you cannot ensure the affected animal subject to verification in accordance food is not adulterated under section with § 507.45(a)(3) and records review in 402 of the Federal Food, Drug, and Cos- accordance with § 507.49(a)(4)(i). metic Act. (b)(1) Except as provided by para- § 507.45 Verification. graph (c) of this section, you are subject to the requirements of paragraph (a) Verification activities must in- (b)(2) of this section if any of the fol- clude, as appropriate to the nature of lowing circumstances apply: the preventive control and its role in (i) A preventive control is not prop- the facility’s food safety system: erly implemented and a corrective ac- (1) Validation in accordance with tion procedure has not been estab- § 507.47; lished; (2) Verification that monitoring is (ii) A preventive control, combina- being conducted as required by § 507.39 tion of preventive controls, or the food (and in accordance with § 507.40); safety plan as a whole is found to be in- (3) Verification that appropriate de- effective; or cisions about corrective actions are (iii) A review of records in accord- being made as required by § 507.39 (and ance with § 507.49(a)(4) finds that the in accordance with § 507.42); records are not complete, the activities (4) Verification of implementation conducted did not occur in accordance and effectiveness in accordance with with the food safety plan, or appro- § 507.49; and priate decisions were not made about (5) Reanalysis in accordance with corrective actions. § 507.50. (2) If any of the circumstances listed in paragraph (b)(1) of this section (b) All verification activities con- apply, you must: ducted in accordance with this section (i) Take corrective action to identify must be documented in records. and correct the problem; (ii) Reduce the likelihood that the § 507.47 Validation. problem will recur; (a) You must validate that the pre- (iii) Evaluate all affected animal food ventive controls identified and imple- for safety; mented in accordance with § 507.34 are

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adequate to control the hazard as ap- § 507.49 Verification of implementation propriate to the nature of the preven- and effectiveness. tive control and its role in the facili- (a) You must verify that the preven- ty’s food safety system. tive controls are consistently imple- (b) The validation of the preventive mented and are effectively and signifi- controls: cantly minimizing or preventing the (1) Must be performed (or overseen) hazards. To do so, you must conduct by a preventive controls qualified individual: activities that include the following, as (i)(A) Prior to implementation of the appropriate to the facility, the animal food safety plan; or food, and the nature of the preventive (B) When necessary to demonstrate control and its role in the facility’s the control measures can be imple- food safety system: mented as designed: (1) Calibration of process monitoring (1) Within 90 calendar days after pro- and verification instruments (or check- duction of the applicable animal food ing them for accuracy); first begins; or (2) Product testing for a pathogen (or (2) Within a reasonable timeframe, appropriate indicator organism) or provided that the preventive controls other hazard; qualified individual prepares (or over- (3) Environmental monitoring, for an sees the preparation of) a written jus- environmental pathogen or for an ap- tification for a timeframe that exceeds propriate indicator organism, if con- 90 calendar days after production of the tamination of an animal food with an applicable animal food first begins; environmental pathogen is a hazard re- (ii) Whenever a change to a control quiring a preventive control, by col- measure or combination of control lecting and testing environmental sam- measures could impact whether the ples; and control measure or combination of con- (4) Review of the following records trol measures, when properly imple- within the specified timeframes, by (or mented, will effectively control the under the oversight of) a preventive hazards; and controls qualified individual, to ensure (iii) Whenever a reanalysis of the the records are complete, the activities food safety plan reveals the need to do so. reflected in the records occurred in ac- (2) Must include obtaining and evalu- cordance with the food safety plan, the ating scientific and technical evidence preventive controls are effective, and (or, when such evidence is not available appropriate decisions were made about or is inadequate, conducting studies) to corrective actions: determine whether the preventive con- (i) Monitoring and corrective action trols, when properly implemented, will records within 7-working days after the effectively control the hazards. records are created or within a reason- (c) You do not need to validate: able timeframe, provided that the pre- (1) The sanitation controls in ventive controls qualified individual § 507.34(c)(2); prepares (or oversees the preparation (2) The recall plan in § 507.38; of) a written justification for a time- (3) The supply-chain program in sub- frame that exceeds 7-working days; and part E of this part; and (ii) Records of calibration, testing (4) Other preventive controls, if the (e.g., product testing, environmental preventive controls qualified individual monitoring), and supplier and supply- prepares (or oversees the preparation chain verification activities, and other of) a written justification that valida- verification activities within a reason- tion is not applicable based on factors able time after the records are created; such as the nature of the hazard, and and the nature of the preventive control (5) Other activities appropriate for and its role in the facility’s food safety verification of implementation and ef- system. fectiveness. [80 FR 56337, Sept. 17, 2015, as amended at 81 FR 3718, Jan. 22, 2016]

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(b) As appropriate to the facility, the § 507.50 Reanalysis. food, the nature of the preventive con- (a) You must conduct a reanalysis of trol, and the role of the preventive con- the food safety plan as a whole at least trol in the facility’s food safety sys- once every 3 years. tem, you must establish and imple- (b) You must conduct a reanalysis of ment written procedures for the fol- the food safety plan as a whole, or the lowing activities: applicable portion of the food safety (1) The method and frequency of cali- plan: brating process monitoring instru- (1) Whenever a significant change in ments and verification instruments (or the activities conducted at your facil- checking them for accuracy) as re- ity creates a reasonable potential for a quired by paragraph (a)(1) of this sec- new hazard or creates a significant in- tion; crease in a previously identified haz- (2) Product testing as required by ard; paragraph (a)(2) of this section. Proce- (2) Whenever you become aware of dures for product testing must: new information about potential haz- (i) Be scientifically valid; ards associated with the animal food; (ii) Identify the test microorga- (3) Whenever appropriate after an un- nism(s) or other analyte(s); anticipated animal food safety problem in accordance with § 507.42(b); and (iii) Specify the procedures for iden- (4) Whenever you find that a preven- tifying samples, including their relative control, combination of preventive tionship to specific lots of product; controls, or the food safety plan as a (iv) Include the procedures for sam- whole is ineffective. pling, including the number of samples (c) You must complete the reanalysis and the sampling frequency; required by paragraphs (a) and (b) of (v) Identify the test(s) conducted, in- this section and validate, as appro- cluding the analytical method(s) used; priate to the nature of the preventive (vi) Identify the laboratory con- control and its role in the facility’s ducting the testing; and food safety system, any additional pre- (vii) Include the corrective action ventive controls needed to address the procedures required by § 507.42(a)(1). hazard identified: (3) Environmental monitoring as re- (1) Before any change in activities quired by paragraph (a)(3) of this sec- (including any change in preventive tion. Procedures for environmental control) at the facility is operative; or monitoring must: (2) When necessary to demonstrate (i) Be scientifically valid; the control measures can be imple- (ii) Identify the test microorga- mented as designed: nism(s); (i) Within 90 calendar days after pro- (iii) Identify the locations from duction of the applicable animal food which samples will be collected and the first begins; or (ii) Within a reasonable timeframe, number of sites to be tested during rou- provided that the preventive controls tine environmental monitoring. The qualified individual prepares (or over- number and location of sampling sites sees the preparation of) a written jus- must be adequate to determine wheth- tification for a timeframe that exceeds er preventive controls are effective; 90 calendar days after production of the (iv) Identify the timing and fre- applicable animal food first begins. quency for collecting and testing sam- (d) You must revise the written food ples. The timing and frequency for col- safety plan if a significant change in lecting and testing samples must be the activities conducted at your facil- adequate to determine whether preven- ity creates a reasonable potential for a tive controls are effective; new hazard or a significant increase in (v) Identify the test(s) conducted, in- a previously identified hazard, or docu- cluding the analytical method(s) used; ment the basis for the conclusion that (vi) Identify the laboratory con- no revisions are needed. ducting the testing; and (e) A preventive controls qualified in- (vii) Include the corrective action dividual must perform (or oversee) the procedures required by § 507.42(a)(1)(ii). reanalysis.

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(f) You must conduct a reanalysis of able timeframe, provided that the pre- the food safety plan when FDA deter- ventive controls qualified individual mines it is necessary to respond to new prepares (or oversees the preparation hazards and developments in scientific of) a written justification for a time- understanding. frame that exceeds 7-working days; and (5) Establish and maintain the fol- [80 FR 56337, Sept. 17, 2015, as amended at 81 FR 3718, Jan. 22, 2016] lowing records: (i) Records (whether affirmative § 507.51 Modified requirements that records demonstrating temperature is apply to a facility solely engaged in controlled or exception records dem- the storage of unexposed packaged onstrating loss of temperature control) animal food. documenting the monitoring of tem- (a) If a facility that is solely engaged perature controls for any such refrig- in the storage of unexposed packaged erated packaged animal food; animal food stores any such refrig- (ii) Records of corrective actions erated packaged animal food that re- taken when there is a loss of tempera- quires time/temperature control to sig- ture control that may impact the safe- nificantly minimize or prevent the ty of any such refrigerated packaged growth of, or toxin formation by patho- animal food; and gens, the facility must conduct the fol- (iii) Records documenting the lowing activities as appropriate to en- verification activities. sure the effectiveness of the tempera- (b) The records that a facility must ture controls: establish and maintain under para- (1) Establish and implement tempera- graph (a)(5) of this section are subject ture controls adequate to significantly to the requirements of subpart F of minimize or prevent the growth of, or this part. toxin formation by, pathogens; [80 FR 56337, Sept. 17, 2015, as amended at 81 (2) Monitor the temperature controls FR 3718, Jan. 22, 2016] with adequate frequency to provide assurance that the temperature controls § 507.53 Requirements applicable to a are consistently performed; preventive controls qualified indi- (3) If there is a loss of temperature vidual and a qualified auditor. control that may impact the safety of (a) One or more preventive controls such refrigerated packaged animal qualified individuals must do or over- food, take appropriate corrective ac- see the following: tions to: (1) Preparation of the food safety (i) Correct the problem and reduce plan (§ 507.31(b)); the likelihood that the problem will (2) Validation of the preventive con- recur; trols (§ 507.47(b)(1)); (ii) Evaluate all affected animal food (3) Written justification for valida- for safety; and tion to be performed in a timeframe (iii) Prevent the animal food from en- that exceeds the first 90 calendar days tering commerce, if you cannot ensure of production of the applicable animal the affected animal food is not adulter- food; ated under section 402 of the Federal (4) Determination that validation is Food, Drug, and Cosmetic Act; not required (§ 507.47(c)(4)); (4) Verify that temperature controls (5) Review of records (§ 507.49(a)(4)); are consistently implemented by: (6) Written justification for review of (i) Calibrating temperature moni- records of monitoring and corrective toring and recording devices (or check- actions within a timeframe that ex- ing them for accuracy); ceeds 7-working days; (ii) Reviewing records of calibration (7) Reanalysis of the food safety plan within a reasonable time after the (§ 507.50(d)); and records are created; and (8) Determination that reanalysis can (iii) Reviewing records of monitoring be completed, and additional preven- and corrective actions taken to correct tive controls validated, as appropriate a problem with the control of tempera- to the nature of the preventive control ture within 7-working days after the and its role in the facility’s food safety records are created or within a reason- system, in a timeframe that exceeds

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the first 90 calendar days of production (vii) Records review; and of the applicable animal food. (viii) Reanalysis; (b) A qualified auditor must conduct (5) Records that document the sup- an onsite audit (§ 507.135(a)). ply-chain program; and (c)(1) To be a preventive controls (6) Records that document applicable qualified individual, the individual training for the preventive controls must have successfully completed qualified individual and the qualified training in the development and appli- auditor. cation of risk-based preventive con- (b) The records that you must estab- trols at least equivalent to that re- lish and maintain are subject to the received under a standardized curriculum quirements of subpart F of this part. recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety Subpart D—Withdrawal of a system. Job experience may qualify an Qualified Facility Exemption individual to perform these functions if § 507.60 Circumstances that may lead such experience has provided an indi- FDA to withdraw a qualified facil- vidual with knowledge at least equiva- ity exemption. lent to that provided through the standardized curriculum. This indi- (a) FDA may withdraw a qualified fa- vidual may be, but is not required to cility exemption under § 507.5(d): be, an employee of the facility; and (1) In the event of an active inves- (2) To be a qualified auditor, a quali- tigation of a foodborne illness outbreak fied individual must have technical ex- that is directly linked to the qualified pertise obtained through education, facility; or training, or experience (or a combina- (2) If FDA determines that it is nec- tion thereof) necessary to perform the essary to protect the public (human or auditing function. animal) health and prevent or mitigate (d) All applicable training in the de- a foodborne illness outbreak based on velopment and application of risk- conditions or conduct associated with based preventive controls must be doc- the qualified facility that are material umented in records, including the date to the safety of the animal food manu- of the training, the type of training, factured, processed, packed, or held at and the person(s) trained. such facility. (b) Before FDA issues an order to § 507.55 Implementation records re- withdraw a qualified facility exemp- quired for this subpart. tion, FDA: (a) You must establish and maintain (1) May consider one or more other the following records documenting im- actions to protect the public (human or plementation of the food safety plan: animal) health or mitigate a foodborne (1) Documentation, as required by illness outbreak, including, a warning § 507.36(b), of the basis for not estab- letter, recall, administrative deten- lishing a preventive control in accord- tion, suspension of registration, refusal ance with § 507.36(a); of animal food offered for import, sei- (2) Records that document the moni- zure, and injunction; toring of preventive controls; (2) Must notify the owner, operator, (3) Records that document corrective or agent in charge of the facility, in actions; writing of circumstances that may lead (4) Records that document FDA to withdraw the exemption, and verification, including, as applicable, provide an opportunity for the owner, those related to: operator, or agent in charge of the fa- (i) Validation; cility to respond in writing, within 15 (ii) Verification of monitoring; calendar days of the date of receipt of (iii) Verification of corrective ac- the notification, to FDA’s notification; tions; and (iv) Calibration of process moni- (3) Must consider the actions taken toring and verification instruments; by the facility to address the cir- (v) Product testing; cumstances that may lead FDA to (vi) Environmental monitoring; withdraw the exemption.

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§ 507.62 Issuance of an order to with- order in accordance with the require- draw a qualified facility exemption. ments of § 507.69. (a) An FDA District Director in (e) A statement that a facility may whose district the qualified facility is request that FDA reinstate an exemp- located (or, in the case of a foreign fa- tion that was withdrawn by following cility, the Director of the Division of the procedures in § 507.85; Compliance in the Center for Veteri- (f) The text of section 418(l) of the nary Medicine), or an FDA official sen- Federal Food, Drug, and Cosmetic Act ior to either such Director, must ap- and of this subpart; prove an order to withdraw the exemp- (g) A statement that any informal tion before the order is issued. hearing on an appeal of the order must (b) Any officer or qualified employee be conducted as a regulatory hearing of FDA may issue an order to withdraw under part 16 of this chapter, with cer- the exemption after it has been ap- tain exceptions described in § 507.73; proved in accordance with paragraph (h) The mailing address, telephone (a) of this section. number, email address, and facsimile (c) FDA must issue an order to with- number of the FDA district office and draw the exemption to the owner, oper- the name of the FDA District Director ator, or agent in charge of the facility. in whose district the facility is located (d) FDA must issue an order to with- (or, in the case of a foreign facility, the draw the exemption in writing, signed same information for the Director of and dated by the officer or qualified the Division of Compliance in the Cen- employee of FDA who is issuing the ter for Veterinary Medicine); and order. (i) The name and the title of the FDA representative who approved the order. § 507.65 Contents of an order to withdraw a qualified facility exemption. [80 FR 56337, Sept. 17, 2015, as amended at 81 An order to withdraw a qualified fa- FR 3718, Jan. 22, 2016] cility exemption under § 507.5(d) must § 507.67 Compliance with, or appeal of, include the following information: an order to withdraw a qualified fa- (a) The date of the order; cility exemption. (b) The name, address, and location of the qualified facility; (a) If you receive an order under (c) A brief, general statement of the § 507.65 to withdraw a qualified facility reasons for the order, including infor- exemption, you must either: mation relevant to one or both of the (1) Comply with applicable require- following circumstances that leads ments of this part within 120 calendar FDA to issue the order: days of the date of receipt of the order, (1) An active investigation of a or within a reasonable timeframe, foodborne illness outbreak that is di- agreed to by FDA, based on a written rectly linked to the facility; or justification, submitted to FDA, for a (2) Conditions or conduct associated timeframe that exceeds 120 calendar with a qualified facility that are mate- days from the date of receipt of the rial to the safety of the animal food order; or manufactured, processed, packed, or (2) Appeal the order within 15 cal- held at such facility. endar days of the date of receipt of the (d) A statement that the facility order in accordance with the require- must either: ments of § 507.69. (1) Comply with subparts C and E of (b) Submission of an appeal, includ- this part on the date that is 120 cal- ing submission of a request for an in- endar days after the date of receipt of formal hearing, will not operate to the order or within a reasonable time- delay or stay any administrative ac- frame, agreed to by FDA, based on a tion, including enforcement action by written justification, submitted to FDA, unless the Commissioner of Food FDA, for a timeframe that exceeds 120 and Drugs, as a matter of discretion, calendar days from the date of receipt determines that delay or a stay is in of the order; or the public interest. (2) Appeal the order within 15 cal- (c) If you appeal the order, and FDA endar days of the date of receipt of the confirms the order:

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(1) You must comply with applicable § 507.73 Requirements applicable to an requirements of this part within 120 informal hearing. calendar days of the date of receipt of If you request an informal hearing, the order, or within a reasonable time- and FDA grants the request: frame, agreed to by FDA, based on a (a) The hearing will be held within 15 written justification, submitted to calendar days after the date the appeal FDA, for a timeframe that exceeds 120 is filed or, if applicable, within a time- calendar days from the date of receipt frame agreed upon in writing by you of the order; and and FDA. (2) You are no longer subject to the (b) The presiding officer may require requirements in § 507.7. that a hearing conducted under this subpart be completed within 1 calendar § 507.69 Procedure for submitting an appeal. day, as appropriate. (c) FDA must conduct the hearing in (a) To appeal an order to withdraw a accordance with part 16 of this chapter, qualified facility exemption, you must: except that: (1) Submit the appeal in writing to (1) The order withdrawing an exemp- the FDA District Director in whose dis- tion under §§ 507.62 and 507.65, rather trict the facility is located (or, in the than the notice under § 16.22(a) of this case of a foreign facility, the Director chapter, provides notice of opportunity of the Division of Compliance in the for a hearing under this section and is Center for Veterinary Medicine), at the part of the administrative record of the mailing address, email address, or fac- regulatory hearing under § 16.80(a) of simile number identified in the order this chapter. within 15 calendar days of the date of (2) A request for a hearing under this receipt of confirmation of the order; subpart must be addressed to the FDA and District Director (or, in the case of a (2) Respond with particularity to the foreign facility, the Director of the Di- facts and issues contained in the order, vision of Compliance in the Center for including any supporting documenta- Veterinary Medicine) as provided in tion upon which you rely. the order withdrawing an exemption. (b) In a written appeal of the order (3) Section 507.75, rather than withdrawing an exemption provided § 16.42(a) of this chapter, describes the under § 507.5(d), you may include a FDA employees who preside at hear- written request for an informal hearing ings under this subpart. as provided in § 507.71. (4) Section 16.60(e) and (f) of this [80 FR 56337, Sept. 17, 2015, as amended at 81 chapter does not apply to a hearing FR 3718, Jan. 22, 2016] under this subpart. The presiding officer must prepare a written report of § 507.71 Procedure for requesting an the hearing. All written material pre- informal hearing. sented at the hearing will be attached (a) If you appeal the order, you: to the report. The presiding officer (1) May request an informal hearing; must include as part of the report of and the hearing a finding on the credibility (2) Must submit any request for an of witnesses (other than expert wit- informal hearing together with your nesses) whenever credibility is a mate- written appeal submitted in accordance rial issue, and must include a proposed with § 507.69 within 15 calendar days of decision, with a statement of reasons. the date of receipt of the order. The hearing participant may review (b) A request for an informal hearing and comment on the presiding officer’s may be denied, in whole or in part, if report within 2 calendar days of the presiding officer determines that issuance of the report. The presiding no genuine and substantial issue of ma- officer will then issue the final deci- terial fact has been raised by the mate- sion. rial submitted. If the presiding officer (5) Section 16.80(a)(4) of this chapter determines that a hearing is not justi- does not apply to a regulatory hearing fied, written notice of the determina- under this subpart. The presiding offi- tion will be given to you explaining the cer’s report of the hearing and any reason for the denial. comments on the report by the hearing

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participant under paragraph (c)(4) of issue a final decision on the appeal this section are part of the administra- confirming or revoking the withdrawal tive record. within 10 calendar days after the date (6) No party shall have the right, the appeal is filed. under § 16.119 of this chapter to petition the Commissioner of Food and Drugs § 507.80 Revocation of an order to for reconsideration or a stay of the pre- withdraw a qualified facility ex- siding officer’s final decision. emption. (7) If FDA grants a request for an in- An order to withdraw a qualified fa- formal hearing on an appeal of an order cility exemption is revoked if: withdrawing an exemption, the hearing (a) You appeal the order and request must be conducted as a regulatory an informal hearing, FDA grants the hearing under a regulation in accord- request for an informal hearing, and ance with part 16 of this chapter, ex- the presiding officer does not confirm cept that § 16.95(b) does not apply to a the order within the 10 calendar days hearing under this subpart. With re- after the hearing, or issues a decision spect to a regulatory hearing under revoking the order within that time; or this subpart, the administrative record (b) You appeal the order and request of the hearing specified in §§ 16.80(a)(1) an informal hearing, FDA denies the through (3), and (a)(5), of this chapter, request for an informal hearing, and and 507.73(c)(5) constitutes the exclu- FDA does not confirm the order within sive record for the presiding officer’s the 10 calendar days after the appeal is final decision. For purposes of judicial filed, or issues a decision revoking the review under § 10.45 of this chapter, the order within that time; or record of the administrative pro- (c) You appeal the order without re- ceeding consists of the record of the questing an informal hearing, and FDA hearing and the presiding officer’s final does not confirm the order within the decision. 10 calendar days after the appeal is filed, or issues a decision revoking the § 507.75 Residing officer for an appeal order within that time. and for an informal hearing. The presiding officer for an appeal, § 507.83 Final agency action. and for an informal hearing, must be Confirmation of a withdrawal order an Office of Regulatory Affairs Pro- by the presiding officer is considered a gram Director or another FDA official final agency action for purposes of 5 senior to an FDA District Director. U.S.C. 702. [82 FR 14147, Mar. 17, 2017] § 507.85 Reinstatement of a qualified § 507.77 Timeframe for issuing a deci- facility exemption that was with- sion on an appeal. drawn. (a) If you appeal the order without (a) If the FDA District Director in requesting a hearing, the presiding offi- whose district your facility is located cer must issue a written report that in- (or, in the case of a foreign facility, the cludes a final decision confirming or Director of the Division of Compliance revoking the withdrawal by the 10th in the Center for Veterinary Medicine) calendar day after the appeal is filed. determines that a facility has ade- (b) If you appeal the order and re- quately resolved any problems with the quest an informal hearing: conditions and conduct that are mate- (1) If FDA grants the request for a rial to the safety of the animal food hearing and the hearing is held, the manufactured, processed, packed, or presiding officer must provide a 2 cal- held at the facility and that continued endar day opportunity for the hearing withdrawal of the exemption is not participants to review and submit com- necessary to protect public (human and ments on the report of the hearing animal) health and prevent or mitigate under § 507.73(c)(4), and must issue a a foodborne illness outbreak, the FDA final decision within 10 calendar days District Director in whose district your after the hearing is held; or facility is located (or, in the case of a (2) If FDA denies the request for a foreign facility, the Director of the Di- hearing, the presiding officer must vision of Compliance in the Center for

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Veterinary Medicine) will, on his own (2) A receiving facility that is an im- initiative or on the request of a facil- porter, is in compliance with the for- ity, reinstate the exemption. eign supplier verification requirements (b) You may ask FDA to reinstate an under part 1, subpart L of this chapter, exemption that has been withdrawn and has documentation of verification under the procedures of this subpart as activities conducted under § 1.506(e) of follows: this chapter (which provides assurance (1) Submit a request, in writing, to that the hazards requiring a supply- the FDA District Director in whose dis- chain-applied control for the raw mate- trict your facility is located (or, in the rial or other ingredient have been sig- case of a foreign facility, the Director nificantly minimized or prevented) of the Division of Compliance in the need not conduct supplier verification Center for Veterinary Medicine); and activities for that raw material or (2) Present data and information to other ingredient. demonstrate that you have adequately (3) The requirements in this subpart resolved any problems with the condi- do not apply to animal food that is sup- tions and conduct that are material to plied for research or evaluation use, the safety of the animal food manufac- provided that such animal food: tured, processed, packed, or held at (i) Is not intended for retail sale and your facility, such that continued is not sold or distributed to the public; withdrawal of the exemption is not (ii) Is labeled with the statement necessary to protect public (human and ‘‘Animal food for research or evalua- animal) health and prevent or mitigate tion use’’; a foodborne illness outbreak. (iii) Is supplied in a small quantity (c) If your exemption was withdrawn that is consistent with a research, under § 507.60(a)(1) and FDA later deter- analysis, or quality assurance purpose, mines, after finishing the active inves- the animal food is used only for this tigation of a foodborne illness out- purpose, and any unused quantity is break, that the outbreak is not di- properly disposed of; and rectly linked to your facility, FDA will (iv) Is accompanied with documents, reinstate your exemption under § 507.5(d), and FDA will notify you in in accordance with the practice of the writing that your exempt status has trade, stating that the animal food will been reinstated. be used for research or evaluation purposes and cannot be sold or distributed (d) If your exemption was withdrawn under both § 507.60(a)(1) and (2) and to the public. FDA later determines, after finishing (b) The supply-chain program must the active investigation of a foodborne be written. illness outbreak, that the outbreak is (c) When a supply-chain-applied con- not directly linked to your facility, trol is applied by an entity other than FDA will inform you of this finding the receiving facility’s supplier (e.g., and you may ask FDA to reinstate when a non-supplier applies controls to your exemption under § 507.5(d) in ac- certain produce (i.e., produce covered cordance with the requirements of by part 112 of this chapter), because paragraph (b) of this section. growing, harvesting, and packing activities are under different manage- Subpart E—Supply-Chain Program ment), the receiving facility must: (1) Verify the supply-chain-applied § 507.105 Requirement to establish and control; or implement a supply-chain program. (2) Obtain documentation of an ap- (a)(1) Except as provided by para- propriate verification activity from an- graphs (a)(2) and (3) of this section, the other entity, review and assess the en- receiving facility must establish and tity’s applicable documentation, and implement a risk-based supply-chain document that review and assessment. program for those raw materials and EFFECTIVE DATE NOTE: At 80 FR 56337, other ingredients for which the receiv- Sept. 17, 2015, part 507 was added, effective ing facility has identified a hazard re- Nov. 16, 2015, with the exception of paragraph quiring a supply-chain-applied control. (a)(2) in § 507.105, which is not yet effective.

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§ 507.110 General requirements appli- (ii) The entity or entities that will be cable to a supply-chain program. applying controls for the hazards re- (a) The supply-chain program must quiring a supply-chain-applied control; include: (iii) Supplier performance, including: (1) Using approved suppliers as re- (A) The supplier’s procedures, proc- quired by § 507.120; esses, and practices related to the safe- (2) Determining appropriate supplier ty of the raw material and other ingre- verification activities (including deter- dients; mining the frequency of conducting the (B) Applicable FDA food safety regu- activity) as required by § 507.125; lations and information relevant to the (3) Conducting supplier verification supplier’s compliance with those regu- activities as required by §§ 507.130 and lations, including an FDA warning let- 507.135; ter or import alert relating to the safety of animal food and other FDA com- (4) Documenting supplier verification pliance actions related to animal food activities as required by § 507.175; and safety (or, when applicable, relevant (5) When applicable, verifying a sup- laws and regulations of a country ply-chain-applied control applied by an whose food safety system FDA has offi- entity other than the receiving facili- cially recognized as comparable or has ty’s supplier and documenting that determined to be equivalent to that of verification as required by § 507.175, or the United States, and information rel- obtaining documentation of an appro- evant to the supplier’s compliance with priate verification activity from an- those laws and regulations); and other entity, reviewing and assessing (C) The supplier’s food safety history that documentation, and documenting relevant to the raw materials or other the review and assessment as required ingredients that the receiving facility by § 507.175. receives from the supplier, including (b) The following are appropriate sup- available information about results plier verification activities for raw ma- from testing raw materials or other in- terials and other ingredients: gredients for hazards, audit results re- (1) Onsite audits; lating to the safety of the animal food, (2) Sampling and testing of the raw and responsiveness of the supplier in material or other ingredient; correcting problems; and (3) Review of the supplier’s relevant (iv) Any other factors as appropriate food safety records; and and necessary, such as storage and (4) Other appropriate supplier transportation practices. verification activities based on sup- (2) Considering supplier performance plier performance and the risk associ- can be limited to the supplier’s compli- ated with the raw material or other in- ance history as required by paragraph gredient. (d)(1)(iii)(B) of this section, if the sup- (c) The supply-chain program must plier is: provide assurance that a hazard requir- (i) A qualified facility as defined by ing a supply-chain-applied control has § 507.3; been significantly minimized or pre- (ii) A farm that grows produce and is vented. not a covered farm under part 112 of (d)(1) Except as provided by para- this chapter in accordance with graph (d)(2) of this section, in approv- § 112.4(a), or in accordance with ing suppliers and determining the ap- §§ 112.4(b) and 112.5; or propriate supplier verification activi- (iii) A shell egg producer that is not ties and the frequency with which they subject to the requirements of part 118 are conducted, the following must be of this chapter because it has less than considered: 3,000 laying hens. (i) The hazard analysis of the animal (e) If the owner, operator, or agent in food, including the nature of the haz- charge of a receiving facility deter- ard controlled before receipt of the raw mines through auditing, verification material or other ingredient, applica- testing, document review, relevant ble to the raw material and other in- consumer, customer, or other com- gredients; plaints, or otherwise that the supplier

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is not controlling hazards that the re- (2) An audit conducted by its sup- ceiving facility has identified as re- plier; quiring a supply-chain-applied control, (3) A review by its supplier of that the receiving facility must take and supplier’s own relevant food safety document prompt action in accordance records; or with § 507.42 to ensure that raw mate- (4) The conduct by its supplier of rials or other ingredients from the sup- other appropriate supplier verification plier do not cause animal food that is activities for that supplier within the manufactured or processed by the re- meaning of § 507.110(b)(4). ceiving facility to be adulterated under (c) The requirements of this section section 402 of the Federal Food, Drug, do not prohibit a receiving facility and Cosmetic Act. from relying on an audit provided by its supplier when the audit of the sup- § 507.115 Responsibilities of the receiv- plier was conducted by a third-party ing facility. qualified auditor in accordance with (a)(1) The receiving facility must ap- §§ 507.130(f) and 507.135. prove suppliers. § 507.120 Using approved suppliers. (2) Except as provided by paragraphs (a)(3) and (4) of this section, the receiv- (a) The receiving facility must ap- ing facility must determine and con- prove suppliers in accordance with the duct appropriate supplier verification requirements of § 507.110(d), and docu- activities, and satisfy all documenta- ment that approval, before receiving tion requirements of this subpart. raw materials and other ingredients re- (3) An entity other than the receiving ceived from those suppliers; facility may do any of the following, (b)(1) Written procedures for receiv- provided that the receiving facility re- ing raw materials and other ingredi- views and assesses the entity’s applica- ents must be established and followed; ble documentation, and documents (2) The written procedures for receiv- that review and assessment: ing raw materials and other ingredi- (i) Establish written procedures for ents must ensure that raw materials receiving raw materials and other in- and other ingredients are received only gredients by the entity; from approved suppliers (or, when nec- (ii) Document that written proce- essary and appropriate, on a temporary dures for receiving raw materials and basis from unapproved suppliers whose other ingredients are being followed by raw materials or other ingredients are the entity; and subjected to adequate verification activities before acceptance for use); and (iii) Determine, conduct, or both determine and conduct, the appropriate (3) Use of the written procedures for supplier verification activities, with receiving raw materials and other inappropriate documentation. gredients must be documented. (4) The supplier may conduct and § 507.125 Determining appropriate document sampling and testing of raw supplier verification activities (in- materials and other ingredients, for cluding determining the frequency the hazard controlled by the supplier, of conducting the activity). as a supplier verification activity for a Appropriate supplier verification ac- particular lot of product and provide tivities (including the frequency of such documentation to the receiving conducting the activity) must be deter- facility, provided that the receiving fa- mined in accordance with the require- cility reviews and assesses that documents of § 507.110(d). mentation, and documents that review and assessment. § 507.130 Conducting supplier (b) For the purposes of this subpart, a verification activities for raw mate- receiving facility may not accept any rials and other ingredients. of the following as a supplier (a) Except as provided by paragraphs verification activity: (c), (d), or (e) of this section, one or (1) A determination by its supplier of more of the supplier verification ac- the appropriate supplier verification tivities specified in § 507.110(b), as de- activities for that supplier; termined under § 507.110(d), must be

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conducted for each supplier before eral food safety laws, including rel- using the raw material or other ingre- evant laws and regulations of foreign dient from that supplier and periodi- counties. cally thereafter. (d) If a supplier is a farm that grows (b)(1) Except as provided by para- produce and is not a covered farm graph (b)(2) of this section, when a haz- under part 112 of this chapter in ac- ard in a raw material or other ingre- cordance with § 112.4(a), or in accord- dient will be controlled by the supplier ance with §§ 112.4(b) and 112.5, the re- and is one for which there is a reason- ceiving facility does not need to com- able probability that exposure to the ply with paragraphs (a) and (b) of this hazard will result in serious adverse section for produce that the receiving health consequences or death to hu- facility receives from the farm as a raw mans or animals: material or other ingredient if the re- (i) The appropriate supplier ceiving facility: verification activity is an onsite audit (1) Obtains written assurance that of the supplier; and the raw material or other ingredient (ii) The audit must be conducted be- provided by the supplier is not subject fore using the raw material or other in- to part 112 of this chapter in accord- gredient from the supplier and at least ance with § 112.4(a), or in accordance annually thereafter. with §§ 112.4(b) and 112.5: (2) The requirements of paragraph (i) Before first approving the supplier (b)(1) of this section do not apply if for an applicable calendar year; and there is a written determination that (ii) On an annual basis thereafter, by other verification activities and/or less December 31 of each calendar year, for frequent onsite auditing of the supplier the following calendar year; and provide adequate assurance that the (2) Obtains written assurance, at hazards are controlled. least every 2 years, that the farm ac- (c) If a supplier is a qualified facility knowledges that its food is subject to as defined by § 507.3, the receiving facil- section 402 of the Federal Food, Drug, ity does not need to comply with para- and Cosmetic Act (or, when applicable, graphs (a) and (b) of this section if the that its food is subject to relevant laws receiving facility: and regulations of a country whose (1) Obtains written assurance that food safety system FDA has officially the supplier is a qualified facility as recognized as comparable or has deter- defined by § 507.3: mined to be equivalent to that of the (i) Before first approving the supplier United States). for an applicable calendar year; and (e) If a supplier is a shell egg pro- (ii) On an annual basis thereafter, by ducer that is not subject to the re- December 31 of each calendar year, for quirements of part 118 of this chapter the following calendar year; and because it has less than 3,000 laying (2) Obtains written assurance, at hens, the receiving facility does not least every 2 years, that the supplier is need to comply with paragraphs (a) and producing the raw material or other in- (b) of this section if the receiving facil- gredient in compliance with applicable ity: FDA food safety regulations (or, when (1) Obtains written assurance that applicable, relevant laws and regula- the shell eggs produced by the supplier tions of a country whose food safety are not subject to part 118 because the system FDA has officially recognized shell egg producer has less than 3,000 as comparable or has determined to be laying hens: equivalent to that of the United (i) Before first approving the supplier States). The written assurance must for an applicable calendar year; and include either: (ii) On an annual basis thereafter, by (i) A brief description of the preven- December 31 of each calendar year, for tive controls that the supplier is imple- the following calendar year; and menting to control the applicable haz- (2) Obtains written assurance, at ard in the animal food; or least every 2 years, that the shell egg (ii) A statement that the facility is producer acknowledges that its food is in compliance with State, local, coun- subject to section 402 of the Federal ty, tribal or other applicable non-Fed- Food, Drug, and Cosmetic Act (or,

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when applicable, that its food is sub- food that is the subject of the onsite ject to relevant laws and regulations of audit must be within the scope of the a country whose food safety system official recognition or equivalence de- FDA has officially recognized as com- termination, and the foreign supplier parable or has determined to be equiva- must be in, and under the regulatory lent to that of the United States). oversight of, such country. (f) There must not be any financial (d) If the onsite audit is solely con- conflicts of interest that influence the ducted to meet the requirements of results of the verification activities this subpart by an audit agent of a cer- listed in § 507.110(b) and payment must tification body that is accredited in ac- not be related to the results of the accordance with regulations in part 1, tivity. subpart M of this chapter, the audit is not subject to the requirements in § 507.135 Onsite audit. those regulations. (a) An onsite audit of a supplier must EFFECTIVE DATE NOTE: At 80 FR 56337, be performed by a qualified auditor. Sept. 17, 2015, part 507 was added, effective (b) If the raw material or other ingre- Nov. 16, 2015, with the exception of paragraph dient at the supplier is subject to one (d) in § 507.135, which is not yet effective. or more FDA food safety regulations, an onsite audit must consider such reg- § 507.175 Records documenting the ulations and include a review of the supply-chain program. supplier’s written plan (e.g., Hazard (a) The records documenting the sup- Analysis and Critical Control Point ply-chain program are subject to the (HACCP) plan or other food safety requirements of subpart F of this part. plan), if any, and its implementation, (b) The receiving facility must re- for the hazard being controlled (or, view the records listed in paragraph (c) when applicable, an onsite audit may of this section in accordance with consider relevant laws and regulations § 507.49(a)(4). of a country whose food safety system (c) The receiving facility must docu- FDA has officially recognized as comment the following in records as appli- parable or has determined to be equiva- cable to its supply-chain program: lent to that of the United States). (1) The written supply-chain pro- (c)(1) The following may be sub- gram; stituted for an onsite audit, provided (2) Documentation that a receiving that the inspection was conducted facility that is an importer is in com- within 1 year of the date that the on- pliance with the foreign supplier site audit would have been required to verification program requirements be conducted: under part 1, subpart L of this chapter, (i) The written results of an appro- including documentation of priate inspection of the supplier for verification activities conducted under compliance with applicable FDA food § 1.506(e) of this chapter; safety regulations by FDA, by rep- (3) Documentation of the approval of resentatives of other Federal Agencies a supplier; (such as the United States Department (4) Written procedures for receiving of Agriculture), or by representatives raw materials and other ingredients; of State, local, tribal, or territorial (5) Documentation demonstrating use agencies; or of the written procedures for receiving (ii) For a foreign supplier, the writ- raw materials and other ingredients; ten results of an inspection by FDA or (6) Documentation of the determina- the food safety authority of a country tion of the appropriate supplier whose food safety system FDA has offi- verification activities for raw mate- cially recognized as comparable or has rials and other ingredients; determined to be equivalent to that of (7) Documentation of the conduct of the United States. an onsite audit. This documentation (2) For inspections conducted by the must include: food safety authority of a country (i) The name of the supplier subject whose food safety system FDA has offi- to the onsite audit; cially recognized as comparable or de- (ii) Documentation of audit proce- termined to be equivalent, the animal dures;

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(iii) The dates the audit was con- (12) The following documentation of ducted; an alternative verification activity for (iv) The conclusions of the audit; a supplier that is a qualified facility: (v) Corrective actions taken in re- (i) The written assurance that the sponse to significant deficiencies iden- supplier is a qualified facility as de- tified during the audit; and fined by § 507.3; and (vi) Documentation that the audit (ii) The written assurance that the was conducted by a qualified auditor; supplier is producing the raw material (8) Documentation of sampling and or other ingredient in compliance with testing conducted as a supplier applicable FDA food safety regulations verification activity. This documenta- (or, when applicable, relevant laws and tion must include: regulations of a country whose food (i) Identification of the raw material safety system FDA has officially recog- or other ingredient tested (including nized as comparable or has determined lot number, as appropriate) and the to be equivalent to that of the United number of samples tested; States); (ii) Identification of the test(s) con- (13) The following documentation of ducted, including the analytical meth- an alternative verification activity for od(s) used; a supplier that is a farm that supplies (iii) The date(s) on which the test(s) a raw material or other ingredient and were conducted and the date of the re- is not a covered farm under part 112 of port; this chapter: (iv) The results of the testing; (i) The written assurance that sup- (v) Corrective actions taken in re- plier is not a covered farm under part sponse to detection of hazards; and 112 of this chapter in accordance with (vi) Information identifying the lab- § 112.4(a), or in accordance with oratory conducting the testing; §§ 112.4(b) and 112.5; and (9) Documentation of the review of (ii) The written assurance that the the supplier’s relevant food safety farm acknowledges that its food is sub- records. This documentation must inject to section 402 of the Federal Food, clude: Drug, and Cosmetic Act (or, when ap- (i) The name of the supplier whose plicable, that its food is subject to rel- records were reviewed; evant laws and regulations of a coun- (ii) The date(s) of review; try whose food safety system FDA has (iii) The general nature of the records officially recognized as comparable or reviewed; has determined to be equivalent to (iv) The conclusions of the review; that of the United States); and (14) The following documentation of (v) Corrective actions taken in re- an alternative verification activity for sponse to significant deficiencies iden- a supplier that is a shell egg producer tified during the review; that is not subject to the requirements (10) Documentation of other appro- established in part 118 of this chapter priate supplier verification activities because it has less than 3,000 laying based on the supplier performance and hens: the risk associated with the raw mate- (i) The written assurance that the rial or other ingredient; shell eggs provided by the supplier are (11) Documentation of any deter- not subject to part 118 of this chapter mination that verification activities because the supplier has less than 3,000 other than an onsite audit, and/or less laying hens; and frequent onsite auditing of a supplier, (ii) The written assurance that the provide adequate assurance that the shell egg producer acknowledges that hazards are controlled when a hazard its food is subject to section 402 of the in a raw material or other ingredient Federal Food, Drug, and Cosmetic Act will be controlled by the supplier and is (or, when applicable, that its food is one for which there is a reasonable subject to relevant laws and regula- probability that exposure to the hazard tions of a country whose safety system will result in serious adverse health FDA has officially recognized as com- consequences or death to humans or parable or has determined to be equiva- animals; lent to that of the United States);

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(15) The written results of an appro- Subpart F—Requirements Apply- priate inspection of the supplier for ing to Records That Must Be compliance with applicable FDA food Established and Maintained safety regulations by FDA, by representatives of other Federal Agencies § 507.200 Records subject to the re- (such as the United States Department quirements of this subpart. of Agriculture), or by representatives (a) Except as provided by paragraphs from State, local, tribal, or territorial (d) and (e) of this section, all records agencies, or the food safety authority required by this part are subject to all of another country when the results of requirements of this subpart. such an inspection is substituted for an (b) Records obtained by FDA in ac- onsite audit; cordance with this part are subject to (16) Documentation of actions taken the disclosure requirements under part with respect to supplier non-conform- 20 of this chapter. ance; (c) All records required by this part (17) Documentation of verification of must be made promptly available to a duly authorized representative of the a supply-chain-applied control applied Secretary of Health and Human Serv- by an entity other than the receiving ices for official review and copying facility’s supplier; and upon oral or written request. (18) When applicable, documentation (d) The requirements of § 507.206 apply of the receiving facility’s review and only to the written food safety plan. assessment of: (e) The requirements of § 507.202(a)(2), (i) Applicable documentation from an (4), and (5) and (b) do not apply to the entity other than the receiving facility records required by § 507.7. that written procedures for receiving raw materials and other ingredients § 507.202 General requirements apply- are being followed; ing to records. (ii) Applicable documentation, from (a) Records must: an entity other than the receiving fa- (1) Be kept as original records, true cility, of the determination of the ap- copies (such as photocopies, pictures, propriate supplier verification activi- scanned copies, microfilm, microfiche, ties for raw materials and other ingre- or other accurate reproductions of the dients; original records), or electronic records; (2) Contain the actual values and ob- (iii) Applicable documentation, from servations obtained during monitoring an entity other than the receiving fa- and as appropriate, during verification cility, of conducting the appropriate activities; supplier verification activities for raw (3) Be accurate, indelible, and legible; materials and other ingredients; (4) Be created concurrently with per- (iv) Applicable documentation, from formance of the activity documented; its supplier, of: and (A) The results of sampling and test- (5) Be as detailed as necessary to pro- ing conducted by the supplier; or vide history of work performed. (B) The results of an audit conducted (b) All records must include: by a third-party qualified auditor in (1) Information adequate to identify accordance with §§ 507.130(f) and 507.135; the plant or facility (e.g., the name, and and when necessary, the location of the (v) Applicable documentation, from plant or facility); (2) The date and, when appropriate, an entity other than the receiving fa- the time of the activity documented; cility, of verification activities when a (3) The signature or initials of the supply-chain-applied control is applied person performing the activity; and by an entity other than the receiving (4) Where appropriate, the identity of facility’s supplier. the product and the lot code, if any. EFFECTIVE DATE NOTE: At 80 FR 56337, (c) Records that are established or Sept. 17, 2015, part 507 was added, effective maintained to satisfy the requirements Nov. 16, 2015, with the exception of paragraph of this part and that meet the defini- (c)(2) in § 507.175, which is not yet effective. tion of electronic records in § 11.3(b)(6)

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of this chapter are exempt from the re- § 507.212 Use of existing records. quirements of part 11 of this chapter. (a) Existing records (e.g., records that Records that satisfy the requirements are kept to comply with other Federal, of this part, but that also are required State, or local regulations, or for any under other applicable statutory provi- other reason) do not need to be dupli- sions or regulations, remain subject to cated if they contain all of the required part 11 of this chapter. information and satisfy the require- § 507.206 Additional requirements ap- ments of this subpart. Existing records plying to the food safety plan. may be supplemented as necessary to include all of the required information The owner, operator, or agent in and satisfy the requirements of this charge of the facility must sign and subpart. date the food safety plan upon initial (b) The information required by this completion and upon any modification. part does not need to be kept in one set § 507.208 Requirements for record re- of records. If existing records contain tention. some of the required information, any new information required by this part (a)(1) All records required by this may be kept either separately or com- part must be retained at the plant or bined with the existing records. facility for at least 2 years after the date they were prepared. § 507.215 Special requirements appli- (2) Records that a facility relies on cable to a written assurance. during the 3-year period preceding the (a) Any written assurance required applicable calendar year to support its by this part must contain the following status as a qualified facility must be elements: retained at the facility as long as nec- (1) Effective date; essary to support the status of a facil- (2) Printed names and signatures of ity as a qualified facility during the authorized officials; applicable calendar year. (3) The applicable assurance under: (b) Records that relate to the general (i) § 507.36(a)(2); adequacy of the equipment or processes being used by a facility, including the (ii) § 507.36(a)(3); results of scientific studies and evalua- (iii) § 507.36(a)(4); tions, must be retained by the facility (iv) § 507.130(c)(2); for at least 2 years after their use is (v) § 507.130(d)(2); or discontinued (e.g., because the facility (vi) § 507.130(e)(2). has updated the written food safety (b) A written assurance required plan (§ 507.31) or records that document under § 507.36(a)(2), (3) or (4) must in- validation of the written food safety clude: plan (§ 507.45(b))). (1) Acknowledgement that the facil- (c) Except for the food safety plan, ity that provides the written assurance offsite storage of records is permitted assumes legal responsibility to act con- if such records can be retrieved and sistently with the assurance and docu- provided onsite within 24 hours of re- ment its actions taken to satisfy the quest for official review. The food safe- written assurance; and ty plan must remain onsite. Electronic (2) Provision that if the assurance is records are considered to be onsite if terminated in writing by either entity, they are accessible from an onsite loca- responsibility for compliance with the tion. applicable provisions of this part re- (d) If the plant or facility is closed verts to the manufacturer/processor as for a prolonged period, the food safety of the date of termination. plan may be transferred to some other reasonably accessible location but must be returned to the plant or facility within 24 hours for official review upon request.

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PART 509—UNAVOIDABLE CON- mishandling or other intervening acts, TAMINANTS IN ANIMAL FOOD it is an added poisonous or deleterious AND FOOD-PACKAGING MATE- substance to the extent of such in- RIAL crease. (e) Food includes pet food, animal Subpart A—General Provisions feed, and substances migrating to food from food-contact articles. Sec. 509.3 Definitions and interpretations. § 509.4 Establishment of tolerances, 509.4 Establishment of tolerances, regu- regulatory limits, and action levels. latory limits, and action levels. 509.5 Petitions. (a) When appropriate under the cri- 509.6 Added poisonous or deleterious sub- teria of § 509.6, a tolerance for an added stances. poisonous or deleterious substance, 509.7 Unavoidability. which may be a food additive, may be 509.15 Use of polychlorinated biphenyls (PCB’s) in establishments manufacturing established by regulation in subpart B food-packaging materials. of this part under the provisions of section 406 of the act. A tolerance may Subpart B—Tolerances for Unavoidable prohibit any detectable amount of the Poisonous or Deleterious Substances substance in food. 509.30 Temporary tolerances for poly- (b) When appropriate under the cri- chlorinated biphenyls (PCB’s). teria of § 509.6, and under section 402(a)(1) of the act, a regulatory limit Subpart C—Regulatory Limits for Added for an added poisonous or deleterious Poisonous or Deleterious Substances substance, which may be a food addi- [Reserved] tive, may be established by regulation Subpart D—Naturally Occurring Poisonous in subpart C of this part under the pro- or Deleterious Substances [Reserved] visions of sections 402(a)(1) and 701(a) of the act. A regulatory limit may pro- AUTHORITY: 21 U.S.C. 336, 342, 346, 346a, 348, hibit any detectable amount of the sub- 371. stance in food. The regulatory limit established represents the level at which SOURCE: 42 FR 52821, Sept. 30, 1977, unless otherwise noted. food is adulterated within the meaning of section 402(a)(1) of the act. Subpart A—General Provisions (c)(1) When appropriate under the criteria of § 509.6, an action level for an § 509.3 Definitions and interpretations. added poisonous or deleterious sub- (a) Act means the Federal Food, stance, which may be a food additive, Drug, and Cosmetic Act. may be established to define a level of (b) The definitions of terms con- contamination at which a food may be tained in section 201 of the act are ap- regarded as adulterated. plicable to such terms when used in (2) Whenever an action level is estab- this part unless modified in this sec- lished or changed, a notice shall be tion. published in the FEDERAL REGISTER as (c) A naturally occurring poisonous or soon as practicable thereafter. The no- deleterious substance is a poisonous or tice shall call attention to the mate- deleterious substance that is an inher- rial supporting the action level which ent natural constituent of a food and is shall be on file with the Division of not the result of environmental, agri- Dockets Management before the notice cultural, industrial, or other contami- is published. The notice shall invite nation. public comment on the action level. (d) An added poisonous or deleterious (d) A regulation may be established substance is a poisonous or deleterious in subpart D of this part to identify a substance that is not a naturally occurring poisonous or deleterious sub- food containing a naturally occurring stance. When a naturally occurring poisonous or deleterious substance poisonous or deleterious substance is which will be deemed to be adulterated increased to abnormal levels through under section 402(a)(1) of the act. These

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regulations do not constitute a com- (1) The substance cannot be avoided plete list of such foods. by good manufacturing practice. (2) The tolerance established is suffi- [42 FR 52821, Sept. 30, 1977, as amended at 55 FR 20786, May 21, 1990] cient for the protection of the public health, taking into account the extent § 509.5 Petitions. of which the presence of the substance cannot be avoided and the other ways The Commissioner of Food and in which the consumer may be affected Drugs, either on his own initiative or by the same or related poisonous or on behalf of any interested person who deleterious substances. has submitted a petition, may issue a (3) No technological or other changes proposal to establish, revoke, or amend are foreseeable in the near future that a regulation under this part. Any such might affect the appropriateness of the petition shall include an adequate fac- tolerance established. Examples of tual basis to support the petition, shall changes that might affect the appro- be in the form set forth in § 10.30 of this priateness of the tolerance include an- chapter, and will be published in the ticipated improvements in good manu- FEDERAL REGISTER for comment if it facturing practice that would change contains reasonable grounds for the the extent to which use of the sub- proposed regulation. stance is unavoidable and anticipated [42 FR 52821, Sept. 30, 1977, as amended at 54 studies expected to provide significant FR 18280, Apr. 28, 1989] new toxicological or use data. (c) A regulatory limit for an added § 509.6 Added poisonous or deleterious poisonous or deleterious substance in substances. any food may be established when each (a) Use of an added poisonous or dele- of the following criteria is met: terious substance, other than a pes- (1) The substance cannot be avoided ticide chemical, that is also a food ad- by current good manufacturing prac- ditive will be controlled by a regula- tices. tion issued under section 409 of the act (2) There is no tolerance established when possible. When such a use cannot for the substance in the particular food be approved under the criteria of sec- under sections 406, 408, or 409 of the act. tion 409 of the act, or when the added (3) There is insufficient information poisonous or deleterious substance is by which a tolerance may be estab- not a food additive, a tolerance, regu- lished for the substance under section latory limit, or action level may be es- 406 of the act or technological changes tablished pursuant to the criteria in appear reasonably possible that may paragraphs (b), (c), or (d) of this sec- affect the appropriateness of a toler- tion. Residues resulting from the use of ance. The regulatory limit established an added poisonous or deleterious sub- represents the level at which food is stance that is also a pesticide chemical adulterated within the meaning of sec- will ordinarily be controlled by a toler- tion 402(a)(1) of the act. ance established in a regulation issued (d) An action level for an added poi- under sections 406, 408, or 409 of the act sonous or deleterious substance in any by the U.S. Environmental Protection food may be established when the cri- Agency (EPA). When such a regulation teria in paragraph (b) of this section has not been issued, an action level for are met, except that technological or an added poisonous or deleterious sub- other changes that might affect the ap- stance that is also a pesticide chemical propriateness of the tolerance are fore- may be established by the Food and seeable in the near future. An action Drug Administration. The Food and level for an added poisonous or delete- Drug Administration will request EPA rious substance in any food may be es- to recommend such an action level pur- tablished at a level at which the Food suant to the criteria established in and Drug Administration may regard paragraph (d) of this section. the food as adulterated within the (b) A tolerance for an added poi- meaning of section 402(a)(1) of the act, sonous or deleterious substance in any without regard to the criteria in para- food may be established when the fol- graph (b) of this section or in section lowing criteria are met: 406 of the act. An action level will be

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withdrawn when a tolerance or regu- a variety of trade names, including: latory limit for the same substance and Aroclor (United States); Phenoclor use has been established. (France); Colphen (Germany); and (e) Tolerances will be established Kanaclor (Japan). PCB’s are highly sta- under authority appropriate for action ble, heat resistant, and nonflammable levels (sections 306, 402(a), and 701(a) of chemicals. Industrial uses of PCB’s in- the act, together with section 408 or 409 clude, or did include in the past, their of the act, if appropriate) as well as use as electrical transformer and ca- under authority appropriate for toler- pacitor fluids, heat transfer fluids, hy- ances (sections 406 and 701 of the act). draulic fluids, and plasticizers, and in In the event the effectiveness of a tol- formulations of lubricants, coatings, erance is stayed pursuant to section 701(e)(2) of the act by the filing of an and inks. Their unique physical and objection, the order establishing the chemical properties and widespread, tolerance shall be deemed to be an uncontrolled industrial applications order establishing an action level until have caused PCB’s to be a persistent final action is taken upon such objec- and ubiquitous contaminant in the en- tion. vironment, causing the contamination of certain foods. In addition, incidents [42 FR 52821, Sept. 30, 1977, as amended at 55 have occurred in which PCB’s have di- FR 20786, May 21, 1990] rectly contaminated animal feeds as a § 509.7 Unavoidability. result of industrial accidents (leakage (a) Tolerances and action levels in or spillage of PCB fluids from plant this part are established at levels based equipment). These accidents in turn on the unavoidability of the poisonous caused the contamination of food prod- or deleterious substance concerned and ucts intended for human consumption do not establish a permissible level of (meat, milk and eggs). Investigations contamination where it is avoidable. by the Food and Drug Administration (b) Compliance with tolerances, regu- have revealed that a significant per- latory limits, and action levels does centage of paper food-packaging mate- not excuse failure to observe either the rial contains PCB’s which can migrate requirement in section 402(a)(4) of the to the packaged food. The origin of act that food may not be prepared, PCB’s in such material is not fully un- packed, or held under insanitary condi- derstood. Reclaimed fibers containing tions or the other requirements in this carbonless copy paper (contains 3 to 5 chapter that food manufacturers must percent PCB’s) have been identified as observe current good manufacturing a primary source of PCB’s in paper practices. Evidence obtained through products. Some virgin paper products factory inspection or otherwise indi- have also been found to contain PCB’s, cating such a violation renders the the source of which is generally attrib- food unlawful, even though the uted to direct contamination from in- amounts of poisonous or deleterious dustrial accidents from the use of PCB- substances are lower than the cur- containing equipment and machinery rently established tolerances, regu- in food-packaging manufacturing es- latory limits, or action levels. The manufacturer of food must at all times tablishments. Since PCB’s are toxic utilize quality control procedures chemicals, the PCB contamination of which will reduce contamination to the food-packaging materials as a result of lowest level currently feasible. industrial accidents, which can cause the PCB contamination of food, rep- [42 FR 52821, Sept. 30, 1977, as amended at 55 resents a hazard to public health. It is FR 20786, May 21, 1990] therefore necessary to place certain re- § 509.15 Use of polychlorinated strictions on the industrial uses of biphenyls (PCB’s) in establishments PCB’s in establishments manufac- manufacturing food-packaging ma- turing food-packaging materials. terials. (b) The following special provisions (a) Polychlorinated biphenyls (PCB’s) are necessary to preclude the acci- represent a class of toxic industrial dental PCB contamination of food- chemicals manufactured and sold under packaging materials:

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(1) New equipment or machinery for Subpart B—Tolerances for Un- manufacturing food-packaging mate- avoidable Poisonous or Dele- rials shall not contain or use PCB’s. terious Substances (2) On or before September 4, 1973, the management of establishments manu- § 509.30 Temporary tolerances for pol- facturing food-packaging materials ychlorinated biphenyls (PCB’s). shall: (a) Polychlorinated biphenyls (PCB’s) (i) Have the heat exchange fluid used are toxic, industrial chemicals. Be- in existing equipment for manufac- cause of their widespread, uncontrolled turing food-packaging materials sam- industrial applications, PCB’s have be- pled and tested to determine whether it come a persistent and ubiquitous con- contains PCB’s or verify the absence of taminant in the environment. As a re- PCB’s in such formulations by other sult, certain foods and animal feeds, appropriate means. On or before Sept. principally those of animal and marine 4, 1973, any such fluid formulated with origin, contain PCB’s as unavoidable, environmental contaminants. PCB’s PCB’s must to the fullest extent pos- are transmitted to the food portion sible commensurate with current good (meat, milk, and eggs) of food pro- manufacturing practices be replaced ducing animals ingesting PCB con- with a heat exchange fluid that does taminated animal feed. In addition, a not contain PCB’s. significant percentage of paper food- (ii) Eliminate to the fullest extent packaging materials contain PCB’s possible commensurate with current which may migrate to the packaged good manufacturing practices from the food. The source of PCB’s in paper establishment any other PCB-con- food-packaging materials is primarily taining equipment, machinery and ma- of certain types of carbonless copy terials wherever there is a reasonable paper (containing 3 to 5 percent PCB’s) expectation that such articles could in waste paper stocks used for manu- cause food-packaging materials to be- facturing recycled paper. Therefore, come contaminated with PCB’s either temporary tolerances for residues of as a result of normal use or as a result PCB’s as unavoidable environmental or of accident, breakage, or other mishap. industrial contaminants are established for a sufficient period of time (iii) The toxicity and other charac- following the effective date of this teristics of fluids selected as PCB re- paragraph to permit the elimination of placements must be adequately deter- such contaminants at the earliest prac- mined so that the least potentially ticable time. For the purposes of this hazardous replacement is used. In mak- paragraph, the term polychlorinated ing this determination with respect to biphenyls (PCB’s) is applicable to mix- a given fluid, consideration should be tures of chlorinated biphenyl com- given to (a) its toxicity; (b) the max- pounds, irrespective of which mixture imum quantity that could be spilled of PCB’s is present as the residue. The onto a given quantity of food before it temporary tolerances for residues of would be noticed, taking into account PCB’s are as follows: its color and odor; (c) possible signaling (1) 0.2 part per million in finished devices in the equipment to indicate a animal feed for food-producing animals loss of fluid, etc.; and (d) its environ- (except the following finished animal mental stability and tendency to sur- feeds: feed concentrates, feed supple- vive and be concentrated through the ments, and feed premixes). food chain. The judgment as to wheth- (2) 2 parts per million in animal feed er a replacement fluid is sufficiently components of animal origin, including non-hazardous is to be made on an indi- fishmeal and other by-products of ma- vidual installation and operation basis. rine origin and in finished animal feed concentrates, supplements, and pre- (c) The provisions of this section do mixes intended for food-producing ani- not apply to electrical transformers mals. and condensers containing PCB’s in (3) 10 parts per million in paper food- sealed containers. packaging material intended for or used with finished animal feed and any

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components intended for animal feeds. 510.305 Maintenance of copies of approved The tolerance shall not apply to paper medicated feed mill licenses to manufac- food-packaging material separated ture animal feed bearing or containing from the food therein by a functional new animal drugs. barrier which is impermeable to migra- Subpart E—Requirements for Specific New tion of PCB’s. Animal Drugs (b) A compilation entitled ‘‘Analyt- ical Methodology for Polychlorinated 510.410 Corticosteroids for oral, injectable, Biphenyls, February 1973’’ for deter- and ophthalmic use in animals; warnings mining compliance with the tolerances and labeling requirements. established in this section is available 510.440 Injectable iron preparations. 510.455 Requirements for free-choice medi- from the Division of Dockets Manage- cated feeds. ment, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, Subpart F [Reserved] MD 20852. Subpart G—Sponsors of Approved [42 FR 52821, Sept. 30, 1977, as amended at 46 FR 8460, Jan. 27, 1981; 59 FR 14365, Mar. 28, Applications 1994; 68 FR 24879, May 9, 2003] 510.600 Names, addresses, and drug labeler codes of sponsors of approved applica- Subpart C—Regulatory Limits for tions. Added Poisonous or Delete- AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 353, rious Substances [Reserved] 360b, 371, 379e. SOURCE: 40 FR 13807, Mar. 27, 1975, unless Subpart D—Naturally Occurring otherwise noted. Poisonous or Deleterious Sub- stances [Reserved] Subpart A—General Provisions PART 510—NEW ANIMAL DRUGS § 510.3 Definitions and interpretations. As used in this part: Subpart A—General Provisions (a) The term act means the Federal Food, Drug, and Cosmetic Act, as Sec. amended (secs. 201–902, 52 Stat. 1040 et 510.3 Definitions and interpretations. seq., as amended; 21 U.S.C. 321–392). 510.4 Biologics; products subject to license (b) Department means the Department control. 510.7 Consignees of new animal drugs for of Health and Human Services. use in the manufacture of animal feed. (c) Secretary means the Secretary of 510.95 [Reserved] Health and Human Services. (d) Commissioner means the Commis- Subpart B—Specific Administrative Rulings sioner of Food and Drugs. and Decisions (e) Person means individuals, partner- 510.105 Labeling of drugs for use in milk- ships, corporations, and associations. producing animals. (f) The definitions and interpreta- 510.106 Labeling of antibiotic and anti- tions of terms contained in section 201 biotic-containing drugs intended for use of the act shall be applicable to such in milk-producing animals. terms when used in the regulations in 510.110 Antibiotics used in food-producing this part. animals. (g) The term new animal drug means 510.112 Antibiotics used in veterinary medi- any drug intended for use for animals cine and for nonmedical purposes; required data. other than man, including any drug intended for use in animal feed but not Subpart C [Reserved] including such animal feed: (1) The composition of which is such Subpart D—Records and Reports that such drug is not generally recognized, among experts qualified by sci- 510.301 Records and reports concerning experience with animal feeds bearing or entific training and experience to containing new animal drugs for which evaluate the safety and effectiveness of an approved medicated feed mill license animal drugs, as safe and effective for application is in effect. use under the conditions prescribed,

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recommended, or suggested in the la- of such drug, even though such drug or beling thereof; except that such a drug animal feed containing such drug when not so recognized shall not be deemed used in another dosage, or another to be a new animal drug if at any time method or duration of administration prior to June 25, 1938, it was subject to or application, or different condition, the Food and Drug Act of June 30, 1906, is not a new animal drug. as amended, and if at such time its la- (j) Animals used only for laboratory re- beling contained the same representa- search and laboratory research animals tions concerning the conditions of its mean individual animals or groups of use; or animals intended for use and used sole- (2) The composition of which is such ly for laboratory research purposes, re- that such drug, as a result of investiga- gardless of species, and does not in- tions to determine its safety and effec- clude animals intended to be used for tiveness for use under such conditions, any food purposes or animals intended has become so recognized but which to be kept as livestock. has not, otherwise than in such investigations, been used to a material ex- (k) Sponsor means the person request- tent or for a material time under such ing designation for a minor-use or conditions. minor-species drug as defined in part (h) The term animal feed means an ar- 516 of this chapter, who must be the ticle which is intended for use for food real party in interest of the develop- for animals other than man and which ment and the intended or actual pro- is intended for use as a substantial duction and sales of such drug (in this source of nutrients in the diet of the context, the sponsor may be an indi- animal, and is not limited to a mixture vidual, partnership, organization, or intended to be the sole ration of the association). Sponsor also means the animal. person responsible for an investigation (i) The newness of an animal drug, in- of a new animal drug. In this context, cluding a new animal drug intended for the sponsor may be an individual, part- use in or on animal feed, may arise by nership, corporation, or Government reason of: (1) The newness for its in- agency or may be a manufacturer, sci- tended drug use of any substance of entific institution, or an investigator which the drug is comprised, in whole regularly and lawfully engaged in the or in part, whether it be an active sub- investigation of new animal drugs. stance or a menstruum, excipient, car- Sponsor also means the person submit- rier, coating, or other component; (2) ting or receiving approval for a new the newness for its intended drug use of animal drug application (in this con- a combination of two or more sub- text, the sponsor may be an individual, stances, none of which is itself a new partnership, organization, or associa- animal drug; (3) the newness for its in- tion). In all contexts, the sponsor is re- tended drug use of the proportion of a sponsible for compliance with applica- substance in a combination, even ble provisions of the act and regula- though such combination containing tions. such substance in other proportion is not a new animal drug; (4) the newness [40 FR 13807, Mar. 27, 1975, as amended at 50 for its intended drug use in a different FR 7517, Feb. 22, 1985; 54 FR 22741, May 26, species of animal; (5) the newness of its 1989; 64 FR 69190, Dec. 10, 1999; 72 FR 41017, intended drug use in diagnosing, cur- July 26, 2007] ing, mitigating, treating, or preventing a disease, or to affect a structure or § 510.4 Biologics; products subject to license control. function of the animal body, even though such drug is not a new animal An animal drug produced and distrib- drug when used in another disease or to uted in full conformance with the ani- affect another structure or function of mal virus, serum, and toxin law of the body; or (6) the newness of a dos- March 4, 1913 (37 Stat. 832; 21 U.S.C. 151 age, or method or duration of adminis- et seq. ) and any regulations issued tration or application, or any other thereunder shall not be deemed to be condition of use prescribed, rec- subject to section 512 of the Federal ommended, or suggested in the labeling Food, Drug, and Cosmetic Act.

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§ 510.7 Consignees of new animal for such preparations should bear a drugs for use in the manufacture of clear warning that either: animal feed. (1) The article should not be adminis- (a) A new animal drug intended for tered to animals producing milk, since use in the manufacture of animal feed to do so would result in contamination shall be deemed to be unsafe unless at of the milk; or the time of its removal from the estab- (2) The label should bear the fol- lishment of a manufacturer, packer, or lowing statement: ‘‘Warning: Milk that distributor of such drug, such manufac- has been taken from animals during turer, packer, or distributor has an treatment and for ll hours after the unrevoked written statement from the latest treatment must not be used for consignee of such drug, or a notice food’’, the blank being filled in with from the Secretary, to the effect that the figure that the manufacturer has with respect to the use of such drug in determined by appropriate investiga- animal feed the consignee: tion is needed to insure that the milk (1) Holds a license issued under will not carry violative residues result- § 515.20 of this chapter; or ing from use of the preparation. If the (2) Will, if the consignee is not the use of the preparation as recommended user of the drug, ship such drug only to does not result in contamination of the a holder of an approved application milk, neither of the above warning under § 515.10 of this chapter. statements is required. (b) The requirements of paragraph (a) of this section do not apply: [40 FR 13807, Mar. 27, 1975, as amended at 63 (1) Where such drugs are intended for FR 32980, June 17, 1998; 64 FR 51241, Sept. 22, export and/or 1999] (2) When the use of such drug in the manufacture of a finished feed has been § 510.106 Labeling of antibiotic and an- exempted from the requirements of tibiotic-containing drugs intended for use in milk-producing animals. section 512(m) of the act under the conditions specified by regulations pub- Whenever the labeling of an anti- lished in part 558 of this chapter. biotic drug included in the regulations in this chapter suggests or recommends [40 FR 13807, Mar. 27, 1975, as amended at 64 FR 63203, Nov. 19, 1999] its use in milk-producing animals, the label of such drugs shall bear either the § 510.95 [Reserved] statement ‘‘Warning: Not for use in animals producing milk, since this use Subpart B—Specific Administrative will result in contamination of the Rulings and Decisions milk’’ or the statement ‘‘Warning: Milk that has been taken from animals § 510.105 Labeling of drugs for use in during treatment and for llhours milk-producing animals. after the latest treatment must not be (a) Part 526 of this chapter provides used for food’’, the blank being filled in for new animal drugs intended for with the figure that the Commissioner intramammary use in animals and in- has authorized the manufacturer of the cludes conditions of use intended to drug to use. The Commissioner shall prevent the contamination of milk determine what such figures shall be from the use of such drugs. from information submitted by the (b) Preparations containing anti- manufacturer and which the Commis- biotics and other potent drugs labeled sioner considers is adequate to prove with directions for use in milk-pro- that period of time after the latest ducing animals will be misbranded treatment that the milk from treated under section 502(f)(2) of the act unless animals will contain no violative resi- their labeling bears appropriate warn- dues from use of the preparation. If the ings and directions for use to avoid Commissioner determines from the in- adulteration of milk under section formation submitted that the use of 402(a)(2)(c)(ii) of the act. the antibiotic drug as recommended (c) It is the position of the Food and does not result in its appearance in the Drug Administration that the labeling milk, the Commissioner may exempt

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the drug from bearing either of the opment of sensitivity to antibiotics in above warning statements. humans, unauthorized and unsafe resi- [63 FR 32980, June 17, 1998] dues of antibiotics cannot be permitted in food obtained from treated animals. § 510.110 Antibiotics used in food-pro- (d) Based on evaluation of informa- ducing animals. tion available, including the conclu- (a) The Food and Drug Administra- sions of the aforementioned ad hoc tion in the interest of fulfilling its re- Committee, the Commissioner con- sponsibilities with regard to protection cludes that antibiotic preparations in- of the public health has requested an tended for use in food-producing ani- evaluation of the public health aspects mals, other than topical and oph- of the use of antibiotics in veterinary thalmic preparations, are not generally medical and nonmedical uses. There is recognized among qualified experts as particular concern with regard to the having been shown to be safe for their potential hazards associated with the intended use(s) within the meaning of extensive use of antibiotics adminis- section 201(s) of the Federal Food, tered to food-producing animals. Ac- Drug, and Cosmetic Act. cordingly, an ad hoc committee on the (e) Therefore, all exemptions from Veterinary Medical and Nonmedical the provisions of section 409 of the act Uses of Antibiotics was established by for use of antibiotics in food-producing the Food and Drug Administration to animals based on sanctions or approv- study and advise the Commissioner of Food and Drugs on the uses of anti- als granted prior to enactment of the biotics in veterinary medicine and for Food Additives Amendment of 1958 various nonmedical purposes as such (Pub. L. 85–929; 72 Stat. 1784) will be re- uses may affect the enforcement of the voked and the uses which are con- Federal Food, Drug, and Cosmetic Act cluded to be safe will be covered by with respect to their safety and effec- food additive regulations. On those tiveness. products for which there are inad- (b) Based upon an evaluation of the equate residue data, actions will be ini- conclusions of said Committee and tiated to withdraw approval of new- other relevant material, § 510.112 was drug applications under the provisions published in the FEDERAL REGISTER of of section 505 of the act. Antibiotic August 23, 1966 (31 FR 11141), asking preparations, other than those for top- sponsors of drugs containing any anti- ical and ophthalmic application in biotic intended for use in food-pro- food-producing animals, which are not ducing animals to submit data to es- covered by food additive regulations tablish whether such antibiotic and its will be subject to regulatory action metabolites are present as residues in within 180 days after publication of the edible tissues, milk, and eggs from forthcoming revocation order. treated animals. The data on the resi- (f) Because of the variation in the pe- dues of antibiotics in milk from riod of time that antibiotic residues intramammary infusion preparations may remain in edible products from were requested within 60 days and the treated animals, all injectable, data on all other products were re- intramammary infusion, intrauterine, quested within 180 days following the and oral preparations, including medi- date of publication of § 510.112 in the cated premixes intended for use in FEDERAL REGISTER. food-producing animals, are deemed to (c) An evaluation of the data now be new drugs as well as food additives. available shows that use of many antibiotic preparations cause residues in [40 FR 13807, Mar. 27, 1975, as amended at 54 edible products of treated animals for FR 18280, Apr. 28, 1989; 64 FR 403, Jan. 5, 1999] varying and, in some cases, for long periods of time following the last admin- § 510.112 Antibiotics used in veteri- istration. Because of the accumulation nary medicine and for nonmedical of new information with regard to the purposes; required data. development of resistance of bacteria (a) An ad hoc committee, Committee to antibiotics, the ability of bacteria to on the Veterinary Medical and Non- transfer this resistance, and the devel- medical Uses of Antibiotics, was

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formed by the Food and Drug Adminis- should be directed to the Director, Cen- tration to study, and advise the Com- ter for Veterinary Medicine, Food and missioner on, the use of antibiotics in Drug Administration, 7500 Standish veterinary medicine and for various Pl., Rockville, MD 20855. nonmedical purposes as such uses may [40 FR 13807, Mar. 27, 1975, as amended at 46 affect the enforcement of the Federal FR 8460, Jan. 27, 1981; 54 FR 18280, Apr. 28, Food, Drug, and Cosmetic Act with re- 1989; 57 FR 6475, Feb. 25, 1992] spect to the safety and effectiveness of such substances. A copy of the report Subpart C [Reserved] may be obtained from the Food and Drug Administration, Office of Public Affairs, Room 15–05, Parklawn Build- Subpart D—Records and Reports ing, 5600 Fishers Lane, Rockville, MD § 510.301 Records and reports con- 20857. cerning experience with animal (b) On the basis of the report of the feeds bearing or containing new Committee and other information, animal drugs for which an ap- sponsors of drugs containing any anti- proved medicated feed mill license biotic intended for use in food-pro- application is in effect. ducing animals shall submit data for Records and reports of clinical and determining whether or not such anti- other experience with the new animal biotics and their metabolites are drug will be maintained and reported, present as residues in edible tissues, appropriately identified with the new milk, and eggs from treated animals; animal drug application(s) or index however, in the case of a drug for listing(s) to which they relate, to the which such data have already been sub- Center for Veterinary Medicine in du- mitted and for which a regulation has plicate in accordance with the fol- been promulgated under section 409 of lowing: the act, only such data as has been ac- (a) Immediately upon receipt by the cumulated since the issuance of the applicant, complete records or reports regulation need be submitted. covering information of the following (c) The required data shall be sub- kinds: mitted within 180 days of the date of (1) Information concerning any publication of this section in the FED- mixup in the new animal drug or its la- ERAL REGISTER; except that in the case beling with another article. of data on intramammary infusion (2) Information concerning any bac- preparations the data shall be sub- teriological or any significant chem- mitted within 60 days of such publica- ical, physical, or other change or dete- tion. Data demonstrating the absence rioration in the drug, or any failure of in milk of residues of intramammary one or more distributed batches of the infusion preparations when used as di- drug to meet the specifications estab- rected in their labeling are needed lished for it in the new animal drug ap- within the 60-day period because of the plication or request for determination importance of milk in the human diet. of eligibility for indexing. (d) Regulatory proceedings including (b) As soon as possible, and in any revocation of prior sanctions, or ac- event within 15 working days of its re- tions to suspend or amend new drug or ceipt by the applicant, complete antibiotic approvals granted prior to records or reports concerning any in- passage of the Food Additives Amend- formation of the following kinds: ment of 1958 (72 Stat. 1784), may be ini- (1) Information concerning any unex- tiated with regard to the continued pected side effect, injury, toxicity, or marketing of any antibiotic prepara- sensitivity reaction or any unexpected tion on which the required information incidence or severity thereof associ- is not submitted within the period of ated with clinical uses, studies, inves- time prescribed by paragraph (c) of this tigations, or tests, whether or not de- section. termined to be attributable to the new (e) Questions relating to the accept- animal drug, except that this require- ability of proposed research protocols ment shall not apply to the submission and assay methods for determining the of information described in a written amount of antibiotic residues in food communication to the applicant from

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the Food and Drug Administration as may be followed by dystocia, fetal types of information that may be sub- death, retained placenta, and metritis. mitted at other designated intervals. Additionally, corticosteroids used in Unexpected as used in this paragraph dogs, rabbits, and rodents during preg- refers to conditions or developments nancy have produced cleft palate in off- not previously submitted as part of the spring. Use in dogs has resulted in new animal drug application or in sup- other congenital anomalies, including port of the index listing or not encoun- deformed forelegs, phocomelia, and tered during clinical trials of the drug, anasarca. Drugs subject to this section or conditions or developments occur- are required to carry the veterinary ring at a rate higher than shown by in- prescription legend and are subject to formation previously submitted as part the labeling requirements of § 201.105 of of the new animal drug application or this chapter. in support of the index listing or at a (b) In view of these potentially seri- rate higher than encountered during ous side effects, the Food and Drug Ad- such clinical trials. ministration has concluded that the la- (2) Information concerning any un- beling on or within packaged usual failure of the new animal drug to corticosteroid-containing preparations exhibit its expected pharmacological intended for animal use shall bear con- activity. spicuously the following warning state- [40 FR 13807, Mar. 27, 1975, as amended at 54 ment: FR 18280, Apr. 28, 1989; 72 FR 69121, Dec. 6, 2007] Warning: Clinical and experimental data have demonstrated that corticosteroids ad- § 510.305 Maintenance of copies of ap- ministered orally or by injection to animals proved medicated feed mill licenses may induce the first stage of parturition if to manufacture animal feed bearing used during the last trimester of pregnancy or containing new animal drugs. and may precipitate premature parturition followed by dystocia, fetal death, retained Each applicant shall maintain in a placenta, and metritis. single accessible location: Additionally, corticosteroids administered (a) A copy of the approved medicated to dogs, rabbits, and rodents during preg- feed mill license (Form FDA 3448) on nancy have resulted in cleft palate in off- the premises of the manufacturing es- spring. Corticosteroids administered to dogs tablishment; and during pregnancy have also resulted in other (b) Approved or index listed labeling congenital anomalies, including deformed for each Type B and/or Type C feed forelegs, phocomelia, and anasarca. being manufactured on the premises of [49 FR 48535, Dec. 13, 1984] the manufacturing establishment or the facility where the feed labels are § 510.440 Injectable iron preparations. generated. There has been an increasing interest [64 FR 63203, Nov. 19, 1999, as amended at 72 in the use of injectable iron compounds FR 69121, Dec. 6, 2007] for the prevention or treatment of iron-deficiency anemia in animals. Al- Subpart E—Requirements for though some such preparations have Specific New Animal Drugs been shown to be safe, such articles are regarded as new animal drugs within § 510.410 Corticosteroids for oral, the meaning of the Federal Food, Drug, injectable, and ophthalmic use in and Cosmetic Act. Accordingly, an ap- animals; warnings and labeling re- proved new animal drug application is quirements. required prior to the marketing of such (a) The Food and Drug Administra- preparations within the jurisdiction of tion has received reports of side effects the act. In addition to the need for associated with the oral, injectable, demonstrating the safety of such arti- and ophthalmic use of corticosteroid cles, the labeling of such preparations animal drugs. The use of these drugs should not only recommend appro- administered orally or by injection has priate dosages of iron but also declare resulted in premature parturition when the amount (in milligrams) of available administered during the last trimester iron (Fe) per milliliter of the subject of pregnancy. Premature parturition product.

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§ 510.455 Requirements for free-choice (1) Directly in the NADA, by a spon- medicated feeds. sor; and/or (a) What is free-choice medicated feed? (2) To an MF that a sponsor may then For the purpose of this part, free- reference in its NADA with written choice medicated feed is medicated consent of the MF holder. feed that is placed in feeding or grazing (e) What will be stated in the published areas and is not intended to be con- approval for a new animal drug intended sumed fully at a single feeding or to for use in free-choice feed? The approval constitute the entire diet of the ani- of a new animal drug intended for use mal. Free-choice feeds include, but are in free-choice feed, as published in this not limited to, medicated blocks (ag- subchapter, will include: glomerated feed compressed or ren- (1) The formula and/or specifications dered into a solid mass and cohesive of the free-choice medicated feed, enough to hold its form), mineral where the owner of this information re- mixes, and liquid feed tank supple- quests such publication, or ments (‘‘lick tank’’ supplements) con- (2) A statement that the approval has taining one or more new animal drugs. been granted for a proprietary formula The manufacture of medicated free- and/or specifications. choice feeds is subject to the current (f) When is a medicated feed mill license good manufacturing practice regula- required for the manufacture of a free- tions in part 225 of this chapter for choice medicated feed? An approved medicated feeds. medicated feed mill license is required (b) What is required for new animal for the manufacture of the following drugs intended for use in free-choice feed? types of feeds: Any new animal drug intended for use (1) All free-choice medicated feeds in free-choice feed must be approved that contain a Category II drug, and for such use under section 512 of the (2) Free-choice medicated feeds that Federal Food, Drug, and Cosmetic Act contain a Category I drug and use a (the act) (21 U.S.C. 360(b)) or listed in proprietary formula and/or specifica- the index under section 572 of the act tions. (21 U.S.C. 360ccc–1). Such approvals under section 512 of the act must be: [69 FR 30197, May 27, 2004, as amended at 72 (1) An original new animal drug ap- FR 69121, Dec. 6, 2007] plication (NADA), (2) A supplemental NADA, or Subpart F [Reserved] (3) An abbreviated NADA. (c) What are the approval requirements under section 512 of the act for new ani- Subpart G—Sponsors of Approved mal drugs intended for use in free-choice Applications feed? An approval under section 512 of the act for a Type A medicated article § 510.600 Names, addresses, and drug intended for use in free-choice feed labeler codes of sponsors of approved applications. must contain the following information: (a) Section 512(i) of the act requires (1) Data, or reference to data in a publication of names and addresses of master file (MF), showing that the tar- sponsors of approved applications for get animal consumes the new animal new animal drugs. drug in the Type C free-choice feed in (b) In this section each name and ad- an amount that is safe and effective dress is identified by a numerical drug (consumption/effectiveness data); and labeler code. The labeler codes identify (2) Data, or reference to data in an the sponsors of the new animal drug MF, showing the relevant ranges of applications associated with the regu- conditions under which the drug will be lations published pursuant to section chemically and physically stable in the 512(i) of the act. The codes appear in Type C free-choice feed under field con- the appropriate regulations and serve ditions. as a reference to the names and ad- (d) How are consumption/effectiveness dresses listed in this section. The drug and/or stability data to be submitted? The labeler code is established pursuant to data must be submitted as follows: section 510 of the act.

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(1) ALPHABETICAL LISTING OF SPONSORS

Drug labeler Firm name and address code

A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., Jackson, NJ 08527 ...... 057699 Accord Healthcare, Inc., 1009 Slater Rd., suite 210–B, Durham, NC 27703 ...... 016729 ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305–3115 ...... 012286 Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503 ...... 057561 Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112 ...... 017762 Akorn Animal Health, Inc., 1925 West Field Ct., suite 300, Lake Forest, IL 60045 ...... 059399 Alaco, Inc., 1500 North Wilmot Rd., suite 290–C, Tucson, AZ 85712 ...... 064146 Alexion Pharmaceuticals, Inc., 100 College St., New Haven, CT 06510 ...... 069334 American Pharmaceuticals and Cosmetics, Inc., 1401 Joel East Rd., Fort Worth, TX 76140 ...... 065531 Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 01801 ...... 060865 Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043 ...... 086073 AquaBounty Technologies, Inc., Two Clock Tower Pl., suite 395, Maynard, MA 01754 ...... 086053 Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS 66211 ...... 086026 Ark Sciences, Inc., 1101 East 33rd St., suite B304, Baltimore, MD 21218 ...... 076175 Aurora Pharmaceutical, LLC, 1196 Highway 3 South, Northfield, MN 55057–3009 ...... 051072 Axcentive SARL, Chemin de Champouse, Quartier Violesi, 13320 Bouc Bel Air, France ...... 086009 B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756 ...... 067188 Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201 ...... 000859 Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777 ...... 062250 Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506–2002 ...... 000010 Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767 ...... 068330 Ceva Sante Animale, 10 Avenue de la Ballastie`re, 33500 Libourne, France ...... 013744 Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland ...... 061651 Cooperative Research Farms, Box 69, Charlotteville, NY 12036 ...... 051267 Cronus Pharma LLC, 2 Tower Center Blvd., suite 1101, East Brunswick, NJ 08816 ...... 069043 Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland ...... 061623 Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom .... 043264 ECO LLC, 344 Nassau St., Princeton, NJ 08540 ...... 066916 Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 ...... 058198 Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013–3928 ...... 017135 First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123 ...... 058829 Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 28234 ...... 015565 Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., Melville, NY 11747 ...... 025463 G. C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 13201 ...... 010515 GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702 ...... 042976 Halocarbon Products Corp., 887 Kinderkamack Rd., River Edge, NJ 07661 ...... 012164 Happy Jack, Inc., Snow Hill, NC 28580 ...... 023851 Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., Souderton, PA 18964 ...... 063075 Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525 ...... 063604 Hikma International Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118 ...... 059115 HQ Specialty Pharma Corp., 120 Rte. 17 North, suite 130, Paramus, NJ 07652 ...... 042791 Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria ...... 016592 IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd., Greensboro, NC 27409 ...... 065274 IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544 ...... 000115 Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 ...... 000061 Ivaoes Animal Health, 4300 SW 73rd Ave., suite 110, Miami, FL 33155 ...... 086064 JBS United Animal Health II LLC, 322 S. Main St., Sheridan, IN 46069 ...... 051233 Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320, Australia ...... 049480 Kinetic Technologies, LLC, 961 Beasley St., suite 270, Lexington, KY 40509 ...... 051031 LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702 ...... 086047 Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601 ...... 061690 Luitpold Pharmaceuticals, Inc., Animal Health Division, Shirley, NY 11967 ...... 010797 Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767–1861 ...... 054925 Medicis Dermatologics, Inc., 8125 North Hayden Rd., Scottsdale, AZ 85258 ...... 099207 Merial, Inc., 3239 Satellite Blvd., bldg. 500, Duluth, GA 30096–4640 ...... 050604 Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186 ...... 015914 Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478 ...... 051079 Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103 ...... 063286 Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, MS 39120 ...... 049968 Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511 ...... 059051 Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland ...... 055529 Oasmia Pharmaceutical AB, Vallongatan 1, 75228 Uppsala, Sweden ...... 052818 Orion Corp., Orionintie 1, 02200 Espoo, Finland ...... 052483 OXIS International, Inc., 6040 N. Cutter Circle, suite 317, Portland, OR 97217–3935 ...... 024991 Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia ...... 068504 Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514 ...... 055246 Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona, NY 10970 ...... 050057 Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ 07069 ...... 042552

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(1) ALPHABETICAL LISTING OF SPONSORS—Continued

Drug labeler Firm name and address code

Pharmaq AS, Skogmo Industriomrade, N–7863 Overhalla, Norway ...... 015331 Pharmgate LLC, 1800 Sir Tyler Dr., Wilmington, NC 28405 ...... 069254 Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666 ...... 066104 Piramal Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017 ...... 066794 Piramal Healthcare Ltd., Piramal Tower, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013, India ...... 065085 Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053–120, Campinas, Sao Paulo, Brazil ...... 060728 Purina Animal Nutrition LLC, 1080 County Road F West, Shoreview, MN 55126–2910 ...... 017800 Putney, Inc., One Monument Sq., suite 400, Portland, ME 04101 ...... 026637 Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349 ...... 076475 Ridley Block Operations Inc., 424 North Riverfront Dr., P.O. Box 8500, Mankato, MN 56002–8500 ...... 068287 Ridley U.S. Holdings, Inc., 424 North Riverfront Dr., P.O. Box 8500, Mankato, MN 56002–8500 ...... 067949 RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620 ...... 058670 Sergeant’s Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138 ...... 021091 Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215 ...... 058005 Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151 ...... 017153 Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503 ...... 054628 Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752 ...... 037990 Superior Equine Pharmaceuticals, Inc., Pleasant Grove, UT 84062 ...... 027053 Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248 ...... 050378 Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532 ...... 051672 Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503 ...... 052923 Thorn Bioscience LLC, 1044 East Chestnut St., Louisville, KY 40204 ...... 051330 VetDC, Inc., 320 E. Vine Dr., suite 218, Fort Collins, CO 80524 ...... 086072 Ve´toquinol N.–A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5 ...... 059320 Ve´toquinol USA, Inc., 4250 N. Sylvania Ave., Fort Worth, TX 76137 ...... 017030 Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137 ...... 051311 Walco International, Inc., 15 West Putnam, Porterville, CA 93257 049185 Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880...... 000402 Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550 ...... 053923 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 ...... 054771

(2) NUMERICAL LISTING OF SPONSORS

Drug labeler code Firm name and address

000010 Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506–2002. 000061 Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940. 000115 IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544. 000402 Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880. 000859 Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201. 010515 G. C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 13201. 010797 Luitpold Pharmaceuticals, Inc., Animal Health Division, Shirley, NY 11967. 012164 Halocarbon Products Corp., 887 Kinderkamack Rd., River Edge, NJ 07661. 012286 ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305–3115. 012578 Janssen Pharmaceutica NV, Turnhoutseweg 30, B–2340 Beerse, Belgium. 013744 Ceva Sante Animale, 10 Avenue de la Ballastie`re, 33500 Libourne, France. 015331 Pharmaq AS, Skogmo Industriomrade, N–7863 Overhalla, Norway. 015565 Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 28234. 015914 Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186. 016592 Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria. 016729 Accord Healthcare, Inc., 1009 Slater Rd., suite 210–B, Durham, NC 27703. 017030 Ve´toquinol USA, Inc., 4250 N. Sylvania Ave., Fort Worth, TX 76137. 017135 Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013–3928. 017153 Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151. 017762 Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112. 017800 Purina Animal Nutrition, 1080 County Road F West, Shoreview, MN 55126–2910. 021091 Sergeant’s Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138. 023851 Happy Jack, Inc., Snow Hill, NC 28580. 024991 OXIS International, Inc., 6040 N. Cutter Circle, suite 317 Portland, OR 97217–3935. 025463 Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., Melville, NY 11747. 026637 Putney, Inc., One Monument Sq., suite 400, Portland, ME 04101. 027053 Superior Equine Pharmaceuticals, Inc., Pleasant Grove, UT 84062. 037990 Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752. 042552 Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ 07069. 042791 HQ Specialty Pharma Corp., 120 Rte. 17 North, suite 130, Paramus, NJ 07652. 042976 GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702. 043264 Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom. 049185 Walco International, Inc., 15 West Putnam, Porterville, CA 93257.

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(2) NUMERICAL LISTING OF SPONSORS—Continued

Drug labeler code Firm name and address

049480 Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320, Australia. 049968 Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, MS 39120. 050057 Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona, NY 10970. 050378 Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248. 050604 Merial, Inc., 3239 Satellite Blvd., bldg. 500, Duluth, GA 30096–4640. 051031 Kinetic Technologies, LLC, 961 Beasley St., suite 270, Lexington, KY 40509. 051072 Aurora Pharmaceutical, LLC, 1196 Highway 3 South, Northfield, MN 55057–3009. 051079 Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478. 051233 JBS United Animal Health II LLC, 322 S. Main St., Sheridan, IN 46069. 051267 Cooperative Research Farms, Box 69, Charlotteville, NY 12036. 051311 Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137. 051330 Thorn Bioscience LLC, 1044 East Chestnut St., Louisville, KY 40204. 051672 Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532. 052483 Orion Corp., Orionintie 1, 02200 Espoo, Finland. 052818 Oasmia Pharmaceutical AB, Vallongatan 1, 75228 Uppsala, Sweden. 052923 Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503. 053923 Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550. 054628 Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503. 054771 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. 054925 Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767–1861. 055246 Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514. 055529 Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland. 057561 Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503. 057699 A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., Jackson, NJ 08527. 058005 Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215. 058198 Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140. 058670 RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620. 058829 First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123. 059051 Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511. 059115 Hikma International Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118. 059320 Ve´toquinol N.–A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5. 059399 Akorn Animal Health, Inc., 1925 West Field Ct., suite 300, Lake Forest, IL 60045. 060728 Planalquimica Industrial Ltda., Rua das Magnolias nr. Jardim das Bandeiras, CEP 13053–120, Campinas, Sao Alto, Brazil. 060865 Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 01801. 061623 Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland. 061651 Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland. 061690 Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601. 062250 Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777. 062794 Mylan Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478. 063075 Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., Souderton, PA 18964. 063286 Mylan Institutional, LLC, 4901 Hiawatha Dr., Rockford, IL 61103. 063604 Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525. 064146 Alaco, Inc., 1500 North Wilmot Rd., suite 290–C, Tucson, AZ 85712. 065085 Piramal Healthcare Ltd., Piramal Tower, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013, India. 065274 IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd., Greensboro, NC 27409. 065531 American Pharmaceuticals and Cosmetics, Inc., 1401 Joel East Rd., Fort Worth, TX 76140. 066104 Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666. 066794 Piramal Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017. 066916 ECO LLC, 344 Nassau St., Princeton, NJ 08540. 067188 B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756. 067949 Ridley U.S. Holdings, Inc., 424 N. Riverfront Dr., P.O. Box 8500, Mankato, MN 56002–8500. 068287 Ridley Block Operations Inc., 424 North Riverfront Dr., P.O. Box 8500, Mankato, MN 56002-8500. 068330 Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767. 068504 Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia. 069043 Cronus Pharma LLC, 2 Tower Center Blvd., suite 1101, East Brunswick, NJ 08816. 069254 Pharmgate LLC, 1800 Sir Tyler Dr., Wilmington, NC 28405. 069334 Alexion Pharmaceuticals, Inc., 100 College St., New Haven, CT 06510. 076175 Ark Sciences, Inc., 1101 East 33rd St., suite B304, Baltimore, MD 21218. 076475 Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349. 086009 Axcentive SARL, Chemin de Champouse, Quartier Violesi, 13320 Bouc Bel Air, France. 086026 Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS 66211. 086047 LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702. 086053 AquaBounty Technologies, Inc., Two Clock Tower Pl., suite 395, Maynard, MA 01754. 086064 Ivaoes Animal Health, 4300 SW 73rd Ave., suite 110, Miami, FL 33155. 086072 VetDC, Inc., 320 E Vine Dr., suite 218, Fort Collins, CO 80524. 086073 Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043. 099207 Medicis Dermatologics, Inc., 8125 North Hayden Rd., Scottsdale, AZ 85258.

[40 FR 13807, Mar. 27, 1975]

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EDITORIAL NOTES: 1. For FEDERAL REGISTER citations affecting § 510.600, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. 2. At 77 FR 46613, Aug. 6, 2012, § 510.600 was amended by removing the entry for ‘‘012758’’ in the table in paragraph (c)(2); however, the amendment could not be incorporated because ‘‘012758’’ didn’t exist.

EFFECTIVE DATE NOTE: At 83 FR 13635, Mar. 30, 2018, § 510.600 was amended in the table in paragraph (c)(1), by removing the entry for ‘‘Watson Laboratories, Inc.’’; and in the table in paragraph (c)(2), by removing the entry for ‘‘000402’’, effective Apr. 9, 2018.

PART 511—NEW ANIMAL DRUGS tity, and batch or code mark of each FOR INVESTIGATIONAL USE shipment and delivery for a period of 2 years after such shipment and delivery. Sec. Upon the request of a properly author- 511.1 New animal drugs for investigational ized employee of the Department at use exempt from section 512(a) of the reasonable times, he shall make such Federal Food, Drug, and Cosmetic Act. records available for inspection and 511.3 Definitions. copying. AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 360b, (4) The exemption allowed in this 371. paragraph shall not apply to any new animal drug intended for in vitro use in § 511.1 New animal drugs for inves- the regular course of diagnosing or tigational use exempt from section treating disease, including anti- 512(a) of the Federal Food, Drug, bacterial sensitivity discs impregnated and Cosmetic Act. with any new animal drug or drugs, (a) New animal drugs for tests in vitro which discs are intended for use in de- and in laboratory research animals. (1) A termining susceptibility of microorga- shipment or other delivery of a new nisms to the new animal drug or drugs. animal drug or animal feed bearing or (b) New animal drugs for clinical inves- containing a new animal drug intended tigation in animals. A shipment or other solely for tests in vitro or in animals delivery of a new animal drug or an used only for laboratory research pur- animal feed containing a new animal poses shall be exempt from section 512 drug intended for clinical investiga- (a) and (m) of the act if it is labeled as tional use in animals shall be exempt follows: from section 512(a) and (m) of the act if Caution. Contains a new animal drug for all the following conditions are met: investigational use only in laboratory re- (1) The label shall bear the state- search animals or for tests in vitro. Not for ments: use in humans. Caution. Contains a new animal drug for (2) The person distributing or causing use only in investigational animals in clin- the distribution of new animal drugs ical trials. Not for use in humans. Edible for tests in vitro or in animals used products of investigational animals are not only for laboratory research purposes to be used for food unless authorization has under this exemption shall use due dili- been granted by the U.S. Food and Drug Ad- gence to assure that the consignee is ministration or by the U.S. Department of Agriculture. regularly engaged in conducting such tests and that the shipment of the new In the case of containers too small or animal drug will actually be used for otherwise unable to accommodate a tests in vitro or in animals used only label with sufficient space to bear the for laboratory research. caution statements required by para- (3) The person who introduced such graph (a) or (b) of this section, the shipment or who delivered the new ani- statements may be included on the car- mal drug for introduction into inter- ton label and other labeling on or with- state commerce shall maintain ade- in the package from which the new ani- quate records showing the name and mal drug is to be dispensed. post office address of the expert or ex- (2) The person or firm distributing or pert organization to whom the new ani- causing the distribution of the new animal drug is shipped and the date, quan- mal drug or animal feed containing a

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new animal drug shall use due dili- be used for food without prior author- gence to assure that the new animal ization in accordance with the provi- drug or animal feed containing a new sions prescribed in this section. animal drug will actually be used for (b) Approximate dates of the begin- tests in animals and is not used in hu- ning and end of the experiment or se- mans. ries of experiments. (3) The person who introduced such (c) The maximum daily dose(s) to be shipment or who delivered the new ani- administered to a given species, the mal drug or animal feed containing a size of animal, maximum duration of new animal drug for introduction into administration, method(s) of adminis- interstate commerce shall maintain tration, and proposed withdrawal time, adequate records showing the name if any. and post office address of the investigator to whom the new animal drug or (vi) If a sponsor has transferred any animal feed containing a new animal obligations for the conduct of any clin- drug is shipped and the date, quantity, ical study to a contract research orga- and batch or code mark of each ship- nization, a statement containing the ment and delivery for a period of 2 name and address of the contract re- years after such shipment and delivery. search organization, identification of Upon the request of a properly author- the clinical study, and a listing of the ized employee of the Department at obligations transferred. If all obliga- reasonable times, such records shall be tions governing the conduct of the made available for inspection and study have been transferred, a general copying. statement of this transfer—in lieu of a (4) Prior to shipment of the new ani- listing of the specific obligations trans- mal drug for clinical tests in animals, ferred—may be submitted. the sponsor of the investigation shall (5) Authorization for use of edible submit in triplicate to FDA a ‘‘Notice products derived from a treated food- of Claimed Investigational Exemption producing animal may be granted for a New Animal Drug’’ including a under the provisions of this section and signed statement containing the fol- when the following specified conditions lowing information: are met, except that in the case of an (i) The identity of the new animal animal administered any unlicensed drug. experimental veterinary biological (ii) All labeling and other pertinent product regulated under the viruses, information to be supplied to the inves- serums, toxins statute (21 U.S.C., chap- tigators. When such pertinent informa- ter V, sec. 151 et seq. ) the product shall tion includes nonclinical laboratory be exempt from the requirements of studies, the information shall include, this section when U.S. Department of with respect to each nonclinical study, Agriculture approval has been obtained either a statement that the study was as provided in 9 CFR 103.2. Conditional conducted in compliance with the re- authorization may be granted in ad- quirements set forth in part 58 of this vance of identification of the name(s) chapter, or, if the study was not conducted in compliance with such regula- and address(es) of the clinical investi- tions, a brief statement of the reason gator(s) as required by paragraph for the noncompliance. (b)(4)(iii) of this section. Information (iii) The name and address of each required for authorization shall in- clinical investigator. clude, in addition to all other require- (iv) The approximate number of ani- ments of this section, the following: mals to be treated (or if not available, (i) Data to show that consumption of the amount of new animal drug to be food derived from animals treated at shipped). the maximum levels with the min- (v) If the new animal drug is given to imum withdrawal periods, if any, speci- food-producing animals, the statement fied in accordance with paragraph shall contain the following additional (b)(4)(v)(c) of this section, will not be information: inconsistent with the public health; or (a) A commitment that the edible (ii) Data to show that food derived products from such animals shall not from animals treated at the maximum

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levels and with the minimum with- perience to evaluate information ob- drawal periods, if any, specified in ac- tained from the investigation, and cordance with paragraph (b)(4)(v)(c) of shall promptly investigate and report this section, does not contain drug res- to FDA and to all investigators any idues or metabolites. findings associated with use of the new (iii) The name and location of the animal drug that may suggest signifi- packing plant where the animals will cant hazards pertinent to the safety of be processed, except that this require- the new animal drug. ment may be waived, on request, by (iii) Shall not unduly prolong dis- the terms of the authorization. tribution of the new animal drug for Authorizations granted under this investigational use. paragraph do not exempt investiga- (iv) Shall not, nor shall any person tional animals and their products from acting for or on behalf of the sponsor, compliance with other applicable in- represent that the new animal drug is spection requirements. Any person who safe or effective for the purposes for contests a refusal to grant such au- which it is under investigation. This thorization shall have an opportunity requirement is not intended to restrict for a regulatory hearing before FDA the full exchange of scientific informa- pursuant to part 16 of this chapter. tion. (6) On written request of FDA, the (v) Shall not commercially distribute sponsor shall submit any additional in- nor test-market the new animal drug formation reported to or otherwise re- until a new animal drug application is ceived by him with respect to the in- approved pursuant to section 512(c) of vestigation deemed necessary to facili- the act. tate a determination whether there are (9) If the shipment or other delivery grounds in the interest of public health of the new animal drug is imported or for terminating the exemption. offered for importation into the United (7) The sponsor shall assure himself States for clinical investigational use that the new animal drug is shipped in animals, it shall also meet the fol- only to investigators who: lowing conditions: (i) Are qualified by scientific training (i) The importer of all such ship- and/experience to evaluate the safety ments or deliveries is an agent of the and/or effectiveness of the new animal foreign exporter residing in the United drug. States or the ultimate consignee, (ii) Shall maintain complete records which person has, prior to such ship- of the investigations, including comments and deliveries, informed FDA of plete records of the receipt and disposi- his intention to import the new animal tion of each shipment or delivery of the drug as sponsor in compliance with the new animal drug under investigation. conditions prescribed in this subdivi- Copies of all records of the investiga- sion; or tion shall be retained by the investi- (ii) The new animal drug is shipped gator for 2 years after the termination directly to a scientific institution with of the investigation or approval of a adequate facilities and qualified per- new animal drug application. sonnel to conduct laboratory or clin- (iii) Shall furnish adequate and time- ical investigations and is intended ly reports of the investigation to the solely for use in such institutions and sponsor. which institution has submitted a (8) The sponsor: statement as sponsor of the investiga- (i) Shall retain all reports received tion. from investigators for 2 years after the (10) The sponsor shall submit either a termination of the investigation or ap- claim for categorical exclusion under proval of a new animal drug applica- § 25.30 or § 25.33 of this chapter or an en- tion and make such reports available vironmental assessment under § 25.40 of to a duly authorized employee of the this chapter. Department for inspection at all rea- (c) Disqualification of a clinical investi- sonable times. gator. (1) If FDA has information indi- (ii) Shall provide for current moni- cating that an investigator (including toring of the investigation by a person a sponsor-investigator) has repeatedly qualified by scientific training and ex- or deliberately failed to comply with

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the conditions of these exempting regu- foods, including dietary supplements, lations or has repeatedly or delib- that bear a nutrient content claim or a erately submitted to FDA or to the health claim, infant formulas, food and sponsor false information in any re- color additives, and tobacco products; quired report, the Center for Veteri- and nary Medicine will furnish the investi- (ii) Any nonclinical laboratory study gator written notice of the matter intended to support an application for complained of and offer the investi- a research or marketing permit for a gator an opportunity to explain the new animal drug. matter in writing, or, at the option of (3) Each application or submission to the investigator, in an informal con- FDA under the provisions of this chap- ference. If an explanation is offered and ter containing data reported by an in- accepted by the Center for Veterinary vestigator who has been determined to Medicine, the Center will discontinue be ineligible to receive FDA-regulated the disqualification proceeding. If an test articles is subject to examination explanation is offered but not accepted to determine whether the investigator by the Center for Veterinary Medicine, has submitted unreliable data that are the investigator will be given an oppor- essential to the continuation of an in- tunity for a regulatory hearing under vestigation or essential to the approval part 16 of this chapter on the question of a marketing application, or essen- of whether the investigator is eligible tial to the continued marketing of an to receive test articles under this part FDA-regulated product. and eligible to conduct: (4) If the Commissioner determines, (i) Any clinical investigation that after the unreliable data submitted by supports an application for a research the investigator are eliminated from or marketing permit for products regu- consideration, that the data remaining lated by FDA; and are inadequate to support a conclusion (ii) Any nonclinical laboratory study that it is reasonably safe to continue intended to support an application for the investigation, the Commissioner a research or marketing permit for a will notify the sponsor, who shall have new animal drug. an opportunity for a regulatory hear- (2) After evaluating all available in- ing under part 16 of this chapter. If a formation, including any explanation danger to the public health exists, how- presented by the investigator, if the ever, the Commissioner shall termi- Commissioner determines that the in- nate the exemption immediately and vestigator has repeatedly or delib- notify the sponsor of the termination. erately failed to comply with the con- In such case, the sponsor shall have an ditions of the exempting regulations in opportunity for a regulatory hearing this subchapter, or has repeatedly or before FDA under part 16 on the ques- deliberately submitted to FDA or to tion of whether the exemption should the sponsor false information in any be reinstated. The determination that required report, the Commissioner will an investigation may not be considered notify the investigator and the sponsor in support of a research or marketing of any investigation in which the in- application or a notification or peti- vestigator has been named as a partici- tion submission does not, however, re- pant that the investigator is not eligi- lieve the sponsor of any obligation ble to receive test articles under this under any other applicable regulation part. The notification to the investi- to submit to FDA the results of the in- gator and sponsor will provide a state- vestigation. ment of the basis for such determina- (5) If the Commissioner determines, tion. The notification also will explain after the unreliable data submitted by that an investigator determined to be the investigator are eliminated from ineligible to receive test articles under consideration, that the continued ap- this part will be ineligible to conduct: proval of the product for which the (i) Any clinical investigation that data were submitted cannot be justi- supports an application for a research fied, the Commissioner will proceed to or marketing permit for products regu- withdraw approval of the product in ac- lated by FDA, including drugs, bio- cordance with the applicable provisions logics, devices, new animal drugs, of the relevant statutes.

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(6) An investigator who has been de- (2) A sponsor may transfer responsi- termined to be ineligible under para- bility for any or all of the obligations graph (c)(2) of this section may be rein- set forth in this part to a contract re- stated as eligible when the Commis- search organization. Any such transfer sioner determines that the investigator shall be in writing and, if not all obli- has presented adequate assurances that gations are transferred, shall describe the investigator will employ all test each of the obligations being assumed articles, and will conduct any clinical by the contract research organization. investigation that supports an applica- If all obligations are transferred, a gen- tion for a research or marketing per- eral statement that all obligations mit for products regulated by FDA and have been transferred is acceptable. any nonclinical laboratory study in- Any obligation not covered by the tended to support an application for a written description shall be deemed not research or marketing permit for a new animal drug, solely in compliance with to have been transferred. the applicable provisions of this chap- (3) A contract research organization ter. that assumes any obligation of a spon- (d) Termination of exemption. If the sor shall comply with the specific regu- Commissioner finds that: lations in this chapter applicable to (1) The sponsor of the investigation this obligation and shall be subject to has failed to comply with any of the the same regulatory action as a spon- conditions for the exemption estab- sor for failure to comply with any obli- lished under this section, or gation assumed under these regula- (2) The continuance of the investigations. Thus, all references to sponsor in tion is unsafe or otherwise contrary to this part apply to a contract research the public interest or the drug is being organization to the extent that it as- or has been used for purposes other sumes one or more obligations of the than bona fide scientific investigation, sponsor. he shall first notify the sponsor and in- (g) Index of legally marketed unap- vite his immediate correction. If the proved new animal drugs for minor spe- conditions of the exemption are not cies. All provisions of part 511 apply to immediately met, the sponsor shall new animal drugs for investigational have an opportunity for a regulatory use in support of indexing, as described hearing before FDA pursuant of part 16 in section 572 of the act, subject to the of this chapter on whether the exemp- provisions of § 516.125 of this chapter. tion should be terminated. If the exemption is terminated the sponsor [40 FR 13823, Mar. 27, 1975, as amended at 41 shall recall or have destroyed the un- FR 48268, Nov. 2, 1976; 42 FR 15675, Mar. 22, used supplies of the new animal drug. 1977; 50 FR 7517, Feb. 22, 1985; 50 FR 16668, (e) Statements and requests. ‘‘Notice(s) Apr. 26, 1985; 52 FR 8847, Mar. 19, 1987; 54 FR of Claimed Investigational Exemption 18280, Apr. 28, 1989; 57 FR 6475, Feb. 25, 1992; for a New Animal Drug’’ and requests 62 FR 40599, July 29, 1997; 72 FR 69121, Dec. 6, for authorization to use investigational 2007; 77 FR 25359, Apr. 30, 2012; 82 FR 61446, animals and their products for food Dec. 28, 2017] should be addressed to the Department § 511.3 Definitions. of Health and Human Services, Food and Drug Administration, Center for As used in this part: Veterinary Medicine, 7500 Standish Pl., Contract research organization means a Rockville, MD 20855. person that assumes, as an independent (f) Contract research organizations. (1) contractor with the sponsor, one or For purposes of this part and part 514, more of the obligations of a sponsor, contract research organization means a e.g., design of a protocol, selection or person that assumes, as an independent monitoring of investigations, evalua- contractor with the sponsor, one or tion of reports, and preparation of ma- more of the obligations of a sponsor, terials to be submitted to the Food and e.g., design of a protocol, selection or Drug Administration. monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to FDA.

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Investigator means an individual who Subpart B—Administrative Actions on actually conducts a clinical investiga- Applications tion (i.e., under whose immediate direction the drug is administered or dis- 514.80 Records and reports concerning experience with approved new animal drugs. pensed to a subject). In the event an in- 514.87 Annual reports for antimicrobial ani- vestigation is conducted by a team of mal drug sales and distribution. individuals, the investigator is the re- 514.100 Evaluation and comment on applica- sponsible leader of the team. ‘‘Sub- tions. investigator’’ includes any other indi- 514.105 Approval of applications. vidual member of that team. 514.106 Approval of supplemental applica- Sponsor means a person who takes re- tions. 514.110 Reasons for refusing to file applica- sponsibility for and initiates a clinical tions. investigation. The sponsor may be an 514.111 Refusal to approve an application. individual or pharmaceutical company, 514.115 Withdrawal of approval of applica- governmental agency, academic insti- tions. tution, private organization, or other 514.116 Notice of withdrawal of approval of organization. The sponsor does not ac- application. tually conduct the investigation unless 514.117 Adequate and well-controlled stud- the sponsor is a sponsor-investigator. A ies. 514.120 Revocation of order refusing to ap- person other than an individual that prove an application or suspending or uses one or more of its own employees withdrawing approval of an application. to conduct an investigation that it has 514.121 Service of notices and orders. initiated is a sponsor, not a sponsor-investigator, and the employees are in- Subpart C—Hearing Procedures vestigators. 514.200 Notice of opportunity for hearing; Sponsor-Investigator means an indi- notice of participation and requests for vidual who both initiates and conducts hearing; grant or denial of hearing. an investigation, and under whose im- 514.201 Procedures for hearings. mediate direction the investigational drug is administered or dispensed. The Subparts D–E [Reserved] term does not include any person other than an individual. The requirements Subpart F—Judicial Review applicable to a sponsor-investigator 514.235 Judicial review. under this part include both those ap- AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 354, plicable to an investigator and a spon- 356a, 360b, 360ccc, 371, 379e, 381. sor. SOURCE: 40 FR 13825, Mar. 27, 1975, unless [77 FR 25359, Apr. 30, 2012] otherwise noted.

PART 514—NEW ANIMAL DRUG Subpart A—General Provisions APPLICATIONS § 514.1 Applications. Subpart A—General Provisions (a) Applications to be filed under section 512(b) of the act shall be submitted Sec. in the form and contain the informa- 514.1 Applications. 514.3 Definitions. tion described in paragraph (b) of this 514.4 Substantial evidence. section, as appropriate to support the 514.5 Presubmission conferences. particular submission. If any part of 514.6 Amended applications. the application is in a foreign lan- 514.7 Withdrawal of applications without guage, an accurate and complete prejudice. English translation shall be appended 514.8 Supplements and other changes to an to such part. Translations of literature approved application. printed in a foreign language shall be 514.11 Confidentiality of data and informa- accompanied by copies of the original tion in a new animal drug application file. publication. The application must be 514.12 Confidentiality of data and informa- signed by the applicant or by an au- tion in an investigational new animal thorized attorney, agent, or official. If drug notice. the applicant or such authorized rep- 514.15 Untrue statements in applications. resentative does not reside or have a

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place of business within the United (b) Highlights of laboratory studies: States, the application must also fur- The reasons why certain types of stud- nish the name and post office address ies were done or omitted as related to of, and must be countersigned by, an the proposed conditions of use and to authorized attorney, agent, or official information already known about this residing or maintaining a place of busi- class of compounds. Emphasize any un- ness within the United States. Perti- usual or particularly significant phar- nent information may be incorporated macological effects or toxicological in, and will be considered as part of, an findings. application on the basis of specific ref- (c) Highlights of clinical studies: The erence to such information, including rationale of the clinical study plan information submitted under the provi- showing why types of studies were sions of § 511.1 of this chapter, in the done, amended, or omitted as related files of the Food and Drug Administra- to laboratory studies and prior clinical tion; however, the reference must be experience. specific in identifying the information. (d) Conclusions: A short statement of Any reference to information furnished conclusions combining the major by a person other than the applicant points of effectiveness and safety as may not be considered unless its use is they relate to the use of the new ani- authorized in a written statement mal drug. signed by the person who submitted it. (3) Labeling. Three copies of each (b) Applications for new animal drugs piece of all labeling to be used for the shall be submitted in triplicate and as- sembled in the manner prescribed by article (total of 9). paragraph (b)(15) of this section, and (i) All labeling should be identified to shall include the following informa- show its position on, or the manner in tion, as appropriate to support the par- which it is to accompany the market ticular submission: package. (1) Identification. Whether the submis- (ii) Labeling for nonprescription new sion is an original or supplemental ap- animal drugs should include adequate plication; the name and the address of directions for use by the layman under the applicant; the date of the applica- all conditions of use for which the new tion; the trade name(s) (if one has been animal drug is intended, recommended, proposed) and chemical name(s) of the or suggested in any of the labeling or new animal drug. Upon receipt, the ap- advertising sponsored by the applicant. plication will be assigned a number (iii) Labeling for prescription veteri- NADA ll, which shall be used for all nary drugs should bear adequate infor- correspondence with respect to the ap- mation for use under which veterinar- plication. ians can use the new animal drug safe- (2) Table of contents and summary. The ly and for the purposes for which it is application shall be organized in a co- intended, including those purposes for hesive fashion, shall contain a table of which it is to be advertised or rep- contents which identifies the data and resented, in accord with § 201.105 of this other material submitted, and shall chapter. contain a well-organized summary and (iv) All labeling for prescription or evaluation of the data in the following nonprescription new animal drugs shall form: be submitted with any necessary use (i) Chemistry: restrictions prominently and conspicu- (a) Chemical structural formula or ously displayed. description for any new animal drug (v) Labeling for new animal drugs in- substance. tended for use in the manufacture of (b) Relationship to other chemically medicated feeds shall include: or pharmacologically related drugs. (a) Specimens of labeling to be used (c) Description of dosage form and for such new animal drug with ade- quantitative composition. quate directions for the manufacture (ii) Scientific rationale and purpose and use of finished feeds for all condi- the new animal drug is to serve: tions for which the new animal drug is (a) Clinical purpose. intended, recommended, or suggested

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in any of the labeling, including adver- (iii) If it is a new animal drug pro- tising, sponsored by the applicant. In- duced by fermentation: gredient labeling may utilize collective (a) Source and type of microorganism names as provided in § 501.110 of this used to produce the new animal drug. chapter. (b) Composition of media used to (b) Representative labeling proposed produce the new animal drug. to be used for Type B and Type C medi- (c) Type of precursor used, if any, to cated feeds containing the new animal guide or enhance production of the an- drug. tibiotic during fermentation. (vi) Draft labeling may be submitted (d) Name and composition of preserv- for preliminary consideration of an ap- ative, if any, used in the broth. plication. Final printed labeling will (e) A complete description of the ex- ordinarily be required prior to approval traction and purification processes in- of an application. Proposed advertising cluding the names and compositions of for veterinary prescription drugs may the solvents, precipitants, ion ex- be submitted for comment or approval. change resins, emulsifiers, and all (4) Components and composition. A complete list of all articles used for other agents used. production of the new animal drug in- (f) If the new animal drug is produced cluding a full list of the composition of by a catalytic hydrogenation process each article: (such as tetracycline from chlortetra- (i) A full list of the articles used as cycline), a complete description of each components of the new animal drug. chemical reaction with graphic for- This list should include all substances mulas used to produce the new animal used in the synthesis, extraction, or drug, including the names of the cata- other method of preparation of any lyst used, how it is removed, and how new animal drug and in the prepara- the new animal drug is extracted and tion of the finished dosage form, re- purified. gardless of whether they undergo (5) Manufacturing methods, facilities, chemical change or are removed in the and controls. A full description of the process. Each component should be methods used in, and the facilities and identified by its established name, if controls used for, the manufacture, any, or complete chemical name, using processing, and packing of the new ani- structural formulas when necessary for mal drug. This description should in- specific identification. If any propri- clude full information with respect to etary name is used, it should be fol- any new animal drug in sufficient de- lowed by a complete quantitative tail to permit evaluation of the ade- statement of composition. Reasonable quacy of the described methods of man- alternatives for any listed component ufacture, processing, and packing, and may be specified. the described facilities and controls to (ii) A full statement of the composi- determine and preserve the identity, tion of the new animal drug. The state- strength, quality, and purity of the ment shall set forth the name and new animal drug, and the following: amount of each ingredient, whether ac- (i) If the applicant does not himself tive or not, contained in a stated quan- perform all the manufacturing, proc- tity of the new animal drug in the form essing, packaging, labeling, and control in which it is to be distributed (for ex- operations for any new animal drug, he ample, amount per tablet or milliliter) shall: Identify each person who will and a batch formula representative of perform any part of such operations that to be employed for the manufac- and designate the part; and provide a ture of the finished dosage form. All signed statement from each such per- components should be included in the son fully describing, directly or by ref- batch formula regardless of whether erence, the methods, facilities, and they appear in the finished product. controls he will use in his part of the Any calculated excess of an ingredient operation. The statement shall include over the label declaration should be a commitment that no changes will be designated as such and percent excess made without prior approval by the shown. Reasonable variation may be Food and Drug Administration, unless specified. permitted under § 514.8.

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(ii) A description of the qualifica- manufacturing process subsequent to tions, including educational back- making up a batch according to the ground and experience, of the technical formula card and, if so, at what stage and professional personnel who are re- and by whom it is done. sponsible for assuring that the new ani- (d) The precautions used in checking mal drug has the identity, strength, the actual package yield produced from quality, and purity it purports or is a batch of the new animal drug with represented to possess, and a statement the theoretical yield. This should in- of their responsibilities. clude a description of the accounting (iii) A description of the physical fa- for such items as discards, breakage, cilities including building and equip- etc., and the criteria used in accepting ment used in manufacturing, proc- or rejecting batches of drugs in the essing, packaging, labeling, storage, event of an unexplained discrepancy. and control operations. (e) The precautions used to assure (iv) The methods used in the syn- that each lot of the new animal drug is thesis, extraction, isolation, or purifi- packaged with the proper label and la- cation of any new animal drug. When beling, including provisions for label- the specifications and controls applied ing storage and inventory control. to such new animal drugs are inad- (f) Any special precautions used in equate in themselves to determine its the operations. identity, strength, quality, and purity, (vii) The analytical controls used the methods should be described in suf- during the various stages of the manu- ficient detail, including quantities facturing, processing, packaging, and used, times, temperature, pH, solvents, labeling of the new animal drug, in- etc., to determine these characteris- cluding a detailed description of the tics. Alternative methods or variations collection of samples and the analyt- in methods within reasonable limits ical procedures to which they are sub- that do not affect such characteristics jected. The analytical procedures of the new animal drug may be speci- should be capable of determining the fied. A flow sheet and indicated equa- active components within a reasonable tions should be submitted when needed degree of accuracy and of assuring the to explain the process. identity of such components. (v) Precautions to insure proper iden- (a) A description of practicable meth- tity, strength, quality, and purity of ods of analysis of adequate sensitivity the raw materials, whether active or to determine the amount of the new not, including: animal drug in the final dosage form (a) The specifications for acceptance should be included. The dosage form and methods of testing for each lot of may be a finished pharmaceutical prod- raw material. uct, a Type A medicated article, a Type (b) A statement as to whether or not B or a Type C medicated feed, or a each lot of raw materials is given a se- product for use in animal drinking rial number to identify it, and the use water. Where two or more active ingre- made of such numbers in subsequent dients are included, methods should be plant operations. quantitative and specific for each ac- (vi) The instructions used in the tive ingredient. manufacturing, processing, packaging, (b) If the article is one that is rep- and labeling of each dosage form of the resented to be sterile, the same infor- new animal drug, including: mation with regard to the manufac- (a) The method of preparation of the turing, processing, packaging, and the master formula records and individual collection of samples of the drug batch records and the manner in which should be given for sterility controls. these records are used. Include the standards used for accept- (b) The number of individuals check- ance of each lot of the finished drug. ing weight or volume of each indi- (viii) An explanation of the exact sig- vidual ingredient entering into each nificance of any batch control numbers batch of the new animal drug. used in the manufacturing, processing, (c) A statement as to whether or not packaging, and labeling of the new ani- the total weight or volume of each mal drug, including such control num- batch is determined at any stage of the bers that may appear on the label of

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the finished article. State whether turing practice and identifies each es- these numbers enable determination of tablishment, showing the location of the complete manufacturing history of the plant conducting these operations. the product. Describe any methods (6) Samples. Samples of the new ani- used to permit determination of the mal drug and articles used as compo- distribution of any batch if its recall is nents and information concerning required. them may be requested by the Center (ix) Adequate information with re- for Veterinary Medicine as follows: spect to the characteristics of and the (i) Each sample shall consist of four test methods employed for the con- identical, separately packaged subdivi- tainer, closure, or other component sions, each containing at least three parts of the drug package to assure times the amount required to perform their suitability for the intended use. the laboratory test procedures de- (x) A complete description of, and scribed in the application to determine data derived from, studies of the sta- compliance with its control specifica- bility of the new animal drug in the tions for identity and assays. Each of final dosage form, including informa- the samples submitted shall be appro- tion showing the suitability of the ana- priately packaged and labeled to pre- lytical methods used. A description of serve its characteristics, to identify any additional stability studies under- the material and the quantity in each way or planned. Stability data for the subdivision of the sample, and to iden- finished dosage form of the new animal tify each subdivision with the name of drug in the container in which it is to the applicant and the new animal drug be marketed, including any proposed application to which it relates. In- multiple dose container, and, if it is to cluded are: be put into solution at the time of dis- (a) A sample or samples of any ref- pensing, for the solution prepared as erence standard and blank used in the directed. If the new animal drug is in- procedures described in the application tended for use in the manufacture of for assaying each new animal drug and Type C medicated feed as defined in § 558.3 of this chapter, stability data de- other assayed components of the fin- rived from studies in which representa- ished new animal drug. tive formulations of the medicated feed (b) A representative sample or sam- articles are used. Similar data may be ples of each strength of the finished required for Type B medicated feeds as dosage form proposed in the applica- determined by the Food and Drug Ad- tion and employed in the clinical in- ministration on a case-by-case basis. vestigations and a representative sam- Expiration dates shall be proposed for ple or samples of each new animal drug finished pharmaceutical dosage forms from the batch(es) employed in the and Type A medicated articles. If the production of such dosage form. data indicate that an expiration date is (c) A representative sample or sam- needed for Type B or Type C medicated ples of finished market packages of feeds, the applicant shall propose such each strength of the dosage form of the expiration date. If no expiration date is new animal drug prepared for initial proposed for Type B or Type C medi- marketing and, if any such sample is cated feeds, the applicant shall justify not from a representative commercial- its absence with data. scale production batch, such a sample (xi) Additional procedures employed from a representative commercial- which are designed to prevent contami- scale production batch, and a rep- nation and otherwise assure proper resentative sample or samples of each control of the product. An application new animal drug from the batch(es) may be refused unless it includes ade- employed in the production of such quate information showing that the dosage form, provided that in the case methods used in, and the facilities and of new animal drugs marketed in large controls used for, the manufacturing, packages the sample should contain processing, and packaging of the new only three times a sufficient quantity animal drug are adequate to preserve of the new animal drug to allow for its identity, strength, quality, and pu- performing the control tests for drug rity in conformity with good manufac- identity and assays.

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(ii) The following information shall priate (consistent with the proposed be included for the samples when re- usage) conditions of dosage, time, and quested: route of administration; if the drug is (a) For each sample submitted, full given in the feed or water, appropriate information regarding its identity and consumption records of the medicated the origin of any new animal drug con- feed or water and appropriate perform- tained therein (including a statement ance data in the treated animal; if the whether it was produced on a labora- drug is to be used in more than one tory, pilot-plant, or full-production species, drug residue studies or appro- scale) and detailed results of all labora- priate metabolic studies conducted for tory tests made to determine the iden- each species that is food-producing. To tity, strength, quality, and purity of provide these data, a sufficient number the batch represented by the sample, of birds or animals should be used at including assays. each sample interval. Appropriate use (b) For any reference standard sub- of labeled compounds (e.g. radioactive mitted, a complete description of its tracers), may be utilized to establish preparation and the results of all lab- metabolism and depletion curves. Drug oratory tests on it. If the test methods residue levels ordinarily should be de- used differed from those described in termined in muscle, liver, kidney, and the application, full details of the fat and where applicable, in skin, milk, methods employed in obtaining the re- and eggs (yolk and egg white). As a porting results. part of the metabolic studies, levels of (7) Analytical methods for residues. Ap- the drug or metabolite should be deter- plications shall include a description of mined in blood where feasible. Samples practicable methods for determining may be combined where necessary. the quantity, if any, of the new animal Where residues are suspected or known drug in or on food, and any substance to be present in litter from treated ani- formed in or on food because of its use, mals, it may be necessary to include and the proposed tolerance or with- data with respect to such residues be- drawal period or other use restrictions coming components of other agricul- to ensure that the proposed use of this tural commodities because of use of lit- drug will be safe. When data or other ter from treated animals. adequate information establish that it (ii) A new animal drug that has the is not reasonable to expect the new potential to contaminate human food animal drug to become a component of with residues whose consumption could food at concentrations considered un- present a risk of cancer to people must safe, a regulatory method is not re- satisfy the requirements of subpart E quired. of part 500 of this chapter. (i) The kind of information required (8) Evidence to establish safety and ef- by this subdivision may include: Com- fectiveness. (i) An application may be plete experimental protocols for deter- refused unless it contains full reports mining drug residue levels in the edible of adequate tests by all methods rea- products, and the length of time re- sonably applicable to show whether or quired for residues to be eliminated not the new animal drug is safe and ef- from such products following the fective for use as suggested in the pro- drug’s use; residue studies conducted posed labeling. under appropriate (consistent with the (ii) An application may be refused proposed usage) conditions of dosage, unless it includes substantial evidence time, and route of administration to of the effectiveness of the new animal show levels, if any, of the drug and/or drug as defined in § 514.4. its metabolites in test animals during (iii) An application may be refused and upon cessation of treatment and at unless it contains detailed reports of intervals thereafter in order to estab- the investigations, including studies lish a disappearance curve; if the drug made on laboratory animals, in which is to be used in combination with other the purpose, methods, and results ob- drugs, possible effects of interaction tained are clearly set forth of acute, demonstrated by the appropriate dis- subacute, and chronic toxicity, and un- appearance curve or depletion patterns less it contains appropriate clinical after drug withdrawal under appro- laboratory results related to safety and

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efficacy. Such information should in- (viii) If a sponsor has transferred any clude identification of the person who obligations for the conduct of any clin- conducted each investigation, a state- ical study to a contract research orga- ment of where the investigations were nization, the application is required to conducted, and where the raw data are include a statement containing the available in the application. name and address of the contract re- (iv) All information pertinent to an search organization, identifying the evaluation of the safety and effective- clinical study, and listing the obliga- ness of the new animal drug received or tions transferred. If all obligations gov- otherwise obtained by the applicant erning the conduct of the study have from any source, including information been transferred, a general statement derived from other investigations or of this transfer—in lieu of a listing of commercial marketing (for example, the specific obligations transferred— outside the United States), or reports may be submitted. in the scientific literature, both favor- (ix) If original subject records were able and unfavorable, involving the audited or reviewed by the sponsor in new animal drug that is the subject of the course of monitoring any clinical the application and related new animal study to verify the accuracy of the case drugs shall be submitted. An adequate reports submitted to the sponsor, a list summary may be acceptable in lieu of identifying each clinical study so au- a reprint of a published report that dited or reviewed. only supports other data submitted. In- (9) Veterinary feed directive. Three clude any evaluation of the safety or copies of a veterinary feed directive effectiveness of the new animal drug (VFD) must be submitted in a form that has been made by the applicant’s that accounts for the information de- veterinary or medical department, ex- scribed under §§ 558.6(b)(3) and pert committee, or consultants. 558.6(b)(4) of this chapter. (v) If the new animal drug is a combination of active ingredients or ani- (10) Supplemental applications. If it is mal drugs, an application may be re- a supplemental application, full infor- fused unless it includes substantial evi- mation shall be submitted on each pro- dence of the effectiveness of the composed change concerning any state- bination new animal drug as required ment made in the approved applica- in § 514.4. tion. (vi) An application shall include a (11) Applicant’s commitment. It is un- complete list of the names and post of- derstood that the labeling and adver- fice addresses of all investigators who tising for the new animal drug will pre- received the new animal drug. This scribe, recommend, or suggest its use may be incorporated in whole or in only under the conditions stated in the part by reference to information sub- labeling which is part of this applica- mitted under the provisions of § 511.1 of tion and if the article is a prescription this chapter. new animal drug, it is understood that (vii) Explain any omission of reports any labeling which furnishes or pur- from any investigator to whom the in- ports to furnish information for use or vestigational new animal drug has been which prescribes, recommends, or sug- made available. The unexplained omis- gests a dosage for use of the new ani- sion of any reports of investigations mal drug will also contain, in the same made with the new animal drug by the language and emphasis, information applicant or submitted to him by an infor its use including indications, ef- vestigator or the unexplained omission fects, dosages, routes, methods, and of any pertinent reports of investiga- frequency and duration of administra- tions or clinical experience received or tion, any relevant hazards, contra- otherwise obtained by the applicant indications, side effects, and pre- from published literature or other cautions contained in the labeling sources that would bias an evaluation which is part of this application. It is of the safety of the new animal drug or understood that all representations in its effectiveness in use, constitutes this application apply to the drug pro- grounds for the refusal or withdrawal duced until changes are made in con- of the approval of an application. formity with § 514.8.

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(12) Additional commitments. (i) New application is unnecessary if reference animal drugs as defined in § 510.3 of this is made to the application containing chapter, intended for use in the manu- such information. Include in each ap- facture of animal feeds in any State plication information applicable to the will be shipped only to persons who specific dosage form, such as labeling, may receive such drugs in accordance composition, stability data, and meth- with § 510.7 of this chapter. od of manufacture. (ii) The methods, facilities, and con- (vii) Submit in folders amendments, trols described under item 5 of this ap- supplements, and other correspondence plication conform to the current good sent after submission of an original ap- manufacturing practice regulations in plication. The front cover of these sub- subchapter C of this chapter. missions should be identified with the (iii) With respect to each nonclinical name of the applicant, new animal laboratory study contained in the ap- drug, copy number, and the new animal plication, either a statement that the drug application number, if known. study was conducted in compliance (c) When a new animal drug applica- with the good laboratory practice regu- tion is submitted for a new animal lations set forth in part 58 of this chap- drug which has a stimulant, depres- ter, or, if the study was not conducted sant, or hallucinogenic effect on the in compliance with such regulations, a central nervous system, if it appears brief statement of the reason for the that the drug has a potential for abuse, noncompliance. the Commissioner shall forward that (13) [Reserved] information to the Attorney General of (14) Environmental assessment. The ap- the United States. plicant is required to submit either a claim for categorical exclusion under [40 FR 13825, Mar. 27, 1975] § 25.30 or § 25.33 of this chapter or an en- EDITORIAL NOTE: For FEDERAL REGISTER ci- vironmental assessment under § 25.40 of tations affecting § 514.1, see the List of CFR this chapter. Sections Affected, which appears in the (15) Assembling and binding the appli- Finding Aids section of the printed volume cation. Assemble and bind an original and at www.fdsys.gov. and two copies of the application as § 514.3 Definitions. follows: (i) Bind the original or ribbon copy of The definition and interpretation of the application as copy No. 1. terms contained in this section apply (ii) Bind two identical copies as copy to those terms as used throughout sub- No. 2 and copy No. 3. chapter E. (iii) Identify each front cover with Adverse drug experience is any adverse the name of the applicant, new animal event associated with the use of a new drug, and the copy number. animal drug, whether or not considered (iv) Number each page of the applica- to be drug related, and whether or not tion sequentially in the upper right the new animal drug was used in ac- hand corner or in another location so cordance with the approved labeling that the page numbers remain legible (i.e., used according to label directions after the application has been bound, or used in an extralabel manner, in- and organize the application consistent cluding but not limited to different with paragraphs (b) (1) through (14) of route of administration, different spe- this section. Each copy should bear the cies, different indications, or other same page numbering, whether sequen- than labeled dosage). Adverse drug ex- tial in each volume or continuous and perience includes, but is not limited to: sequential throughout the application. (1) An adverse event occurring in ani- (v) Include complete labeling in each mals in the course of the use of an ani- of the copies. It is suggested that label- mal drug product by a veterinarian or ing be identified by date of printing or by a livestock producer or other ani- date of preparation. mal owner or caretaker. (vi) Submit separate applications for (2) Failure of a new animal drug to each different dosage form of the drug produce its expected pharmacological proposed. Repeating basic information or clinical effect (lack of expected ef- pertinent to all dosage forms in each fectiveness).

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(3) An adverse event occurring in hu- chemical, physical, or other change, or mans from exposure during manufac- deterioration in the distributed drug ture, testing, handling, or use of a new product, including any microbial or animal drug. chemical contamination. A manufac- ANADA is an abbreviated new animal turing defect is a product defect caused drug application including all amend- or aggravated by a manufacturing or ments and supplements. related process. A manufacturing de- Applicant is a person or entity who fect may occur from a single event or owns or holds on behalf of the owner from deficiencies inherent to the man- the approval for an NADA or an ufacturing process. These defects are ANADA, and is responsible for compli- generally associated with product con- ance with applicable provisions of the tamination, product deterioration, act and regulations. manufacturing error, defective pack- Increased frequency of adverse drug ex- aging, damage from disaster, or label- perience is an increased rate of occur- ing error. For example, a labeling error rence of a particular serious adverse may include any incident that causes a drug event, expected or unexpected, distributed product to be mistaken for, after appropriate adjustment for drug or its labeling applied to, another prod- exposure. uct. NADA is a new animal drug applica- Serious adverse drug experience is an tion including all amendments and sup- adverse event that is fatal, or life- plements. threatening, or requires professional Nonapplicant is any person other than intervention, or causes an abortion, or the applicant whose name appears on stillbirth, or infertility, or congenital the label and who is engaged in manu- anomaly, or prolonged or permanent facturing, packing, distribution, or la- disability, or disfigurement. beling of the product. Unexpected adverse drug experience is Potential applicant means any person: an adverse event that is not listed in (1) Intending to investigate a new the current labeling for the new animal animal drug under section 512(j) of the drug and includes any event that may Federal Food, Drug, and Cosmetic Act be symptomatically and (the act), pathophysiologically related to an (2) Investigating a new animal drug event listed on the labeling, but differs under section 512(j) of the act, from the event because of greater se- (3) Intending to file a new animal verity or specificity. For example, drug application (NADA) or supple- under this definition hepatic necrosis mental NADA under section 512(b)(1) of would be unexpected if the labeling re- the act, or ferred only to elevated hepatic en- (4) Intending to file an abbreviated zymes or hepatitis. new animal drug application (ANADA) [68 FR 15365, Mar. 31, 2003, as amended at 69 under section 512(b)(2) of the act. FR 51170, Aug. 18, 2004] Presubmission conference means one or more conferences between a potential § 514.4 Substantial evidence. applicant and FDA to reach a binding (a) Definition of substantial evidence. agreement establishing a submission or Substantial evidence means evidence investigational requirement. consisting of one or more adequate and Presubmission conference agreement well-controlled studies, such as a study means that section of the memo- in a target species, study in laboratory randum of conference headed ‘‘Pre- animals, field study, bioequivalence submission Conference Agreement’’ study, or an in vitro study, on the basis that records any agreement on the sub- of which it could fairly and reasonably mission or investigational requirement be concluded by experts qualified by reached by a potential applicant and scientific training and experience to FDA during the presubmission con- evaluate the effectiveness of the new ference. animal drug involved that the new ani- Product defect/manufacturing defect is mal drug will have the effect it pur- the deviation of a distributed product ports or is represented to have under from the standards specified in the ap- the conditions of use prescribed, rec- proved application, or any significant ommended, or suggested in the labeling

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or proposed labeling thereof. Substan- sufficient quality and persuasiveness to tial evidence shall include such ade- permit qualified experts: quate and well-controlled studies that (A) To determine that the param- are, as a matter of sound scientific eters selected for measurement and the judgment, necessary to establish that a measured responses reliably reflect the new animal drug will have its intended effectiveness of the new animal drug; effect. (B) To determine that the results ob- (b) Characteristics of substantial evi- tained are likely to be repeatable, and dence—(1) Qualifications of experts. Any that valid inferences can be drawn to study that is intended to be part of the target animal population; and substantial evidence of the effective- (C) To conclude that the new animal ness of a new animal drug shall be con- drug is effective for the intended use at ducted by experts qualified by sci- the dose or dose range and associated entific training and experience. conditions of use prescribed, rec- (2) Intended uses and conditions of use. ommended, or suggested in the pro- Substantial evidence of effectiveness of posed labeling. a new animal drug shall demonstrate (ii) Types. Adequate and well-con- that the new animal drug is effective trolled studies that are intended to for each intended use and associated provide substantial evidence of the ef- conditions of use for and under which fectiveness of a new animal drug may approval is sought. include, but are not limited to, published studies, foreign studies, studies (i) Dose range labeling. Sponsors using models, and studies conducted by should, to the extent possible, provide or on behalf of the sponsor. Studies for a dose range because it increases using models shall be validated to es- the utility of the new animal drug by tablish an adequate relationship of pa- providing the user flexibility in the se- rameters measured and effects ob- lection of a safe and effective dose. In served in the model with one or more general, substantial evidence to sup- significant effects of treatment. port dose range labeling for a new ani- (c) Substantial evidence for combination mal drug intended for use in the diag- new animal drugs—(1) Definitions. The nosis, cure, mitigation, treatment, or following definitions of terms apply to prevention of disease must consist of at this section: least one adequate and well-controlled (i) Combination new animal drug study on the basis of which qualified means a new animal drug that contains experts could fairly and reasonably more than one active ingredient or ani- conclude that the new animal drug will mal drug that is applied or adminis- be effective for the intended use at the tered simultaneously in a single dosage lowest dose of the dose range suggested form or simultaneously in or on animal in the proposed labeling for that in- feed or drinking water. tended use. Substantial evidence to (ii) Dosage form combination new ani- support dose range labeling for a new mal drug means a combination new ani- animal drug intended to affect the mal drug intended for use other than in structure or function of the body of an animal feed or drinking water. animal generally must consist of at (iii) Antibacterial with respect to a least one adequate and well-controlled particular target animal species means study on the basis of which qualified an active ingredient or animal drug: experts could fairly and reasonably That is approved in that species for the conclude that the new animal drug will diagnosis, cure, mitigation, treatment, be effective for the intended use at all or prevention of bacterial disease; or doses within the range suggested in the that is approved for use in that species proposed labeling for the intended use. for any other use that is attributable (ii) [Reserved] to its antibacterial properties. But, (3) Studies—(i) Number. Substantial antibacterial does not include evidence of the effectiveness of a new ionophores or arsenicals intended for animal drug for each intended use and use in combination in animal feed or associated conditions of use shall con- drinking water. sist of a sufficient number of current (iv) Appropriate concurrent use exists adequate and well-controlled studies of when there is credible evidence that

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the conditions for which the combina- substantial evidence, as defined in this tion new animal drug is intended can section, that each antibacterial makes occur simultaneously. a contribution to labeled effectiveness; (2) Combination new animal drugs that (C) That each active ingredient or contain only active ingredients or animal animal drug intended for at least one drugs that have previously been sepa- use that is different from all other ac- rately approved. (i) For dosage form tive ingredients or animal drugs used combination new animal drugs, except in the combination provides appro- for those that contain a nontopical priate concurrent use for the intended antibacterial, that contain only active target animal population; and ingredients or animal drugs that have (D) That the active ingredients or previously been separately approved animal drugs intended for use in drink- for the particular uses and conditions ing water are physically compatible if of use for which they are intended in FDA, based on scientific information, combination, a sponsor shall dem- has reason to believe the active ingre- onstrate: dients or animal drugs are physically (A) By substantial evidence, as de- incompatible. fined in this section, that any active ingredient or animal drug intended (3) Other combination new animal only for the same use as another active drugs. For all other combination new ingredient or animal drug in the com- animal drugs, the sponsor shall dem- bination makes a contribution to the onstrate by substantial evidence, as de- effectiveness of the combination new fined in this section, that the combina- animal drug; tion new animal drug will have the ef- (B) That each active ingredient or fect it purports or is represented to animal drug intended for at least one have under the conditions of use pre- use that is different from all the other scribed, recommended, or suggested in active ingredients or animal drugs used the proposed labeling and that each ac- in the combination provides appro- tive ingredient or animal drug contrib- priate concurrent use for the intended utes to the effectiveness of the com- target animal population; and bination new animal drug. (C) That the active ingredients or [64 FR 40756, July 28, 1999] animal drugs are physically compatible and do not have disparate dosing regi- § 514.5 Presubmission conferences. mens if FDA, based on scientific information, has reason to believe the ac- (a) General principle underlying the tive ingredients or animal drugs are conduct of a presubmission conference. physically incompatible or have dis- The general principle underlying the parate dosing regimens. conduct of any presubmission con- (ii) For combination new animal ference is that there should be candid, drugs intended for use in animal feed full, and open communication. or drinking water that contain only ac- (b) Requesting a presubmission con- tive ingredients or animal drugs that ference. A potential applicant is enti- have previously been separately ap- tled to one or more conferences prior proved for the particular uses and con- to the submission of an NADA, supple- ditions of use for which they are in- mental NADA, or an ANADA to reach tended in combination, the sponsor an agreement establishing part or all shall demonstrate: of a submission or investigational re- (A) By substantial evidence, as de- quirement. A potential applicant’s refined in this section, that any active quest for a presubmission conference ingredient or animal drug intended must be submitted to FDA in a signed only for the same use as another active letter. The letter must include a pro- ingredient or animal drug in the composed agenda that clearly outlines the bination makes a contribution to the scope, purpose, and objectives of the effectiveness of the combination new presubmission conference and must list animal drug; the names and positions of the rep- (B) For such combination new animal resentatives who are expected to at- drugs that contain more than one anti- tend the presubmission conference on bacterial ingredient or animal drug, by behalf of the applicant.

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(c) Timing. A potential applicant may any agreements reached regarding all request one or more presubmission con- or part of a submission or investiga- ferences at any time prior to the filing tional requirement will be included of a NADA, supplemental NADA, or an under the heading ‘‘Presubmission Con- ANADA. A request for a presubmission ference Agreement.’’ If the pre- conference must be received by FDA at submission conference agreement sec- least 30 calendar days in advance of the tion of the memorandum is silent on an requested conference date. FDA will issue, including one that was discussed schedule the presubmission conference in the conference or addressed by mate- at a time agreeable to both FDA and rials provided for the conference, such the potential applicant. silence does not constitute agreement (d) Advance information. The potential between FDA and the potential appli- applicant must provide to FDA, at cant on the issue. least 30 calendar days before a sched- (ii) Sending a copy to the potential ap- uled presubmission conference, a de- plicant. FDA will send a copy of the tailed agenda, a copy of any materials memorandum to the potential appli- to be presented at the conference, a list cant for review no later than 45 cal- of proposed indications and, if avail- endar days after the date of the con- able, a copy of the proposed labeling ference for the product under consideration, (iii) Requests for changes or clarifica- and copies of materials evaluated or tion. If a potential applicant requests referenced relative to issues listed in changes to, or clarification of, the sub- the agenda for the conference. If the stance of the memorandum, the re- materials are not provided or are not quest must be sent to FDA within 30 sufficient to provide the basis for calendar days from the date a copy of meaningful discussion, FDA may elect the memorandum is sent to the appli- to postpone part or all of the meeting cant. If the potential applicant re- until sufficient materials are provided quests changes or clarification, FDA to FDA. will send the potential applicant a re- (e) Conduct of a presubmission con- sponse to their request no later than 45 ference. The potential applicant and calendar days after the date of receipt FDA may each bring consultants to the presubmission conference. The pre- of the request. submission conference(s) will be di- (iv) Administrative record. A copy of rected primarily at establishing agree- FDA’s original memorandum of con- ment between FDA and the potential ference and, as appropriate, a copy of applicant regarding a submission or in- an amended memorandum to correct or vestigational requirement. The submis- clarify the content of the original sion or investigational requirement memorandum will be made part of the may include, among other things, the administrative file. number, types, and general design of (2) Field studies. If FDA requires more studies that are necessary to dem- than one field study to establish by onstrate the safety and effectiveness of substantial evidence that the new ani- a new animal drug for the intended mal drug is effective for its intended uses and conditions of use prescribed, uses under the conditions of use pre- recommended, or suggested in the pro- scribed, recommended, or suggested in posed labeling for the new animal drug. the proposed labeling, FDA will provide (f) Documentation of a presubmission written scientific justification for re- conference—(1) Memorandum of con- quiring more than one field study. ference—(i) Preparation. FDA will pre- Such justification must be provided no pare a memorandum for each pre- later than 25 calendar days after the submission conference that will in- date of the conference at which the re- clude, among other things, any back- quirement for more than one field ground pertinent to the request for study is established. If FDA does not meeting; a summary of the key points believe more than one field study is re- of discussion; agreements; and action quired but the potential applicant vol- items and assignments of responsi- untarily proposes to conduct more bility. That portion of the memo- than one field study, FDA will not pro- randum of conference that documents vide such written justification. If FDA

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requires one field study to be con- tional exemption. If the dispute cannot ducted at multiple locations, FDA will be resolved after such attempts, the provide justification for requiring mul- dispute shall be evaluated and adminis- tiple locations verbally during the pre- tered in accordance with applicable submission conference and in writing regulations (21 CFR 10.75). Dispute res- as part of the memorandum of con- olution procedures may be further ex- ference. plained by guidance available from the (g) Modification of presubmission con- Center for Veterinary Medicine. ference agreements. An agreement made [69 FR 51170, Aug. 18, 2004] under a presubmission conference requested under section 512(b)(3) of the § 514.6 Amended applications. act and documented in a memorandum The applicant may submit an amend- of conference is binding on the poten- ment to an application that is pending, tial applicant and FDA and may only including changes that may alter the be modified if: conditions of use, the labeling, safety, (1) FDA and the potential applicant effectiveness, identity, strength, qual- mutually agree to modify, in part or in ity, or purity of the drug or the ade- whole, the agreement and such modi- quacy of the manufacturing methods, fication is documented and provided to facilities, and controls to preserve the potential applicant as described in them, in which case the unamended ap- paragraph (f)(1) of this section; or plication may be considered as with- (2) FDA by written order determines drawn and the amended application that a substantiated scientific require- may be considered resubmitted on the ment essential to the determination of date on which the amendment is re- safety or effectiveness of the new ani- ceived by the Food and Drug Adminis- mal drug appeared after the con- tration. The applicant will be notified ference. of such date. (h) When the terms of a presubmission conference agreement are not valid (1) A § 514.7 Withdrawal of applications presubmission conference agreement without prejudice. will no longer be valid if: The sponsor may withdraw his pend- (i) The potential applicant makes to ing application from consideration as a FDA, before, during, or after the pre- new animal drug application upon writ- submission conference, any untrue ten notification to the Food and Drug statement of material fact; or Administration. Such withdrawal may (ii) The potential applicant fails to be made without prejudice to a future follow any material term of the agree- filing. Upon resubmission, the time ment; and limitation will begin to run from the (2) A presubmission conference may date the resubmission is received by no longer be valid if the potential ap- the Food and Drug Administration. plicant submits false or misleading The original application will be re- data relating to a new animal drug to tained by the Food and Drug Adminis- FDA. tration although it is considered with- (i) Dispute resolution. FDA is com- drawn. The applicant shall be furnished mitted to resolving differences between a copy at cost on request. a potential applicant and FDA reviewing divisions with respect to require- § 514.8 Supplements and other changes ments for the investigation of new ani- to an approved application. mal drugs and for NADAs, supple- (a) Definitions. (1) The definitions and mental NADAs, and ANADAs as quick- interpretations contained in section 201 ly and amicably as possible through a of the Federal Food, Drug, and Cos- cooperative exchange of information metic Act (the act) apply to those and views. When administrative or pro- terms when used in this part. cedural disputes arise, a potential ap- (2) The following definitions of terms plicant should first attempt to resolve apply to this part: the matter within the appropriate re- (i) Assess the effects of the change view division beginning with the indi- means to evaluate the effects of a man- vidual(s) most directly assigned to the ufacturing change on the identity, review of the application or investiga- strength, quality, purity, and potency

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of a drug as these factors may relate to or guidance that provides for a less the safety or effectiveness of the drug. burdensome notification of the change (ii) Drug substance means an active (for example, by submission of a sup- ingredient as defined under § 210.3(b)(7) plement that does not require approval of this chapter. prior to distribution of the drug, or by (iii) Minor changes and stability report notification in the next annual report (MCSR) means an annual report that is described in paragraph (b)(4) of this submitted to the application once each section). year within 60 days before or after the (iv) In each supplement and amend- anniversary date of the application’s ment to a supplement providing for a original approval or on a mutually change under paragraph (b)(2) or (b)(3) agreed upon date. The report must in- of this section, the applicant must include minor manufacturing and control clude a statement certifying that a changes made according to § 514.8(b)(4) field copy has been provided to the ap- or state that no changes were made; propriate FDA district office. No field and stability data generated on com- copy is required for a supplement pro- mercial or production batches accord- viding for a change made to a drug ing to an approved stability protocol or manufactured outside of the United commitment. States. (iv) Specification means the quality (v) A supplement or annual report de- standard (i.e., tests, analytical proce- scribed in paragraph (b)(4) of this sec- dures, and acceptance criteria) pro- tion must include a list of all changes vided in an approved application to contained in the supplement or annual confirm the quality of drugs including, report. For supplements, this list must for example, drug substances, Type A be provided in the cover letter. medicated articles, drug products, (2) Changes requiring submission and intermediates, raw materials, reagents, approval of a supplement prior to dis- components, in-process materials, contribution of the drug made using the tainer closure systems, and other ma- change (major changes). (i) A supple- terials used in the production of a drug. For the purpose of this defini- ment must be submitted for any tion, the term ‘‘acceptance criteria’’ change in the drug, production process, means numerical limits, ranges, or quality controls, equipment, or facili- other criteria for the tests described. ties that has a substantial potential to (b) Manufacturing changes to an ap- have an adverse effect on the identity, proved application—(1) General provi- strength, quality, purity, or potency of sions. (i) The applicant must notify the drug as these factors may relate to FDA about each change in each condi- the safety or effectiveness of the drug. tion established in an approved appli- (ii) These changes include, but are cation beyond the variations already not limited to: provided for in the application. The no- (A) Except those described in para- tice is required to describe the change graphs (b)(3) and (b)(4) of this section, fully. Depending on the type of change, changes in the qualitative or quan- the applicant must notify FDA about it titative formulation of the drug, in- in a supplement under paragraph (b)(2) cluding inactive ingredients, or in the or (b)(3) of this section or by inclusion specifications provided in the approved of the information in the annual report application; to the application under paragraph (B) Changes requiring completion of (b)(4) of this section. appropriate clinical studies to dem- (ii) The holder of an approved appli- onstrate the equivalence of the drug to cation under section 512 of the act the drug as manufactured without the must assess the effects of the change change; before distributing a drug made with a (C) Changes that may affect drug manufacturing change. substance or drug product sterility as- (iii) Notwithstanding the require- surance, such as changes in drug sub- ments of paragraphs (b)(2) and (b)(3) of stance, drug product or component this section, an applicant must make a sterilization method(s) or an addition, change provided for in those para- deletion, or substitution of steps in an graphs in accordance with a regulation aseptic processing operation;

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(D) Changes in the synthesis or man- polypeptide, or a complex or conjugate ufacture of the drug substance that of a drug substance with a monoclonal may affect the impurity profile and/or antibody, relevant validation protocols the physical, chemical, or biological and standard operating procedures properties of the drug substance; must be provided in addition to the re- (E) Changes in a drug product con- quirements in paragraphs (b)(2)(iii)(E) tainer closure system that controls the and (b)(2)(iii)(F) of this section; drug delivered to the animal or (I) For sterilization process and test changes in the type or composition of a methodologies related to sterilization packaging component that may affect process validation, relevant validation the impurity profile of the drug prod- protocols and a list of relevant stand- uct; ard operating procedures must be pro- (F) Changes solely affecting a natural vided in addition to the requirements product, a recombinant DNA-derived in paragraphs (b)(2)(iii)(E) and protein/polypeptide, or a complex or (b)(2)(iii)(F) of this section; and conjugate of a drug substance with a (J) Any other information as directed monoclonal antibody for the following: by FDA. (1) Changes in the virus or adven- (iv) An applicant may ask FDA to ex- titious agent removal or inactivation pedite its review of a supplement for method(s), public health reasons or if a delay in (2) Changes in the source material or making the change described in it cell line, and would impose an extraordinary hard- (3) Establishment of a new master ship on the applicant. Such a supple- cell bank or seed; ment and its mailing cover must be (G) Changes to a drug under an appli- plainly marked: ‘‘Prior Approval Sup- cation that is subject to a validity as- plement-Expedited Review Requested.’’ sessment because of significant questions regarding the integrity of the (v) Comparability Protocols. An appli- data supporting that application. cant may submit one or more protocols (iii) The applicant must obtain ap- describing the specific tests and studies proval of a supplement from FDA prior and acceptance criteria to be achieved to distribution of a drug made using a to demonstrate the lack of adverse ef- change under paragraph (b)(2) of this fect for specified types of manufac- section. The supplement must be la- turing changes on the identity, beled ‘‘Prior Approval Supplement.’’ strength, quality, purity, and potency Except for submissions under para- of the drug as these factors may relate graph (b)(2)(v) of this section, the fol- to the safety or effectiveness of the lowing information must be contained drug. Any such protocols, if not in- in the supplement: cluded in the approved application, or (A) A completed Form FDA 356V; changes to an approved protocol, must (B) A detailed description of the pro- be submitted as a supplement requiring posed change; approval from FDA prior to distribu- (C) The drug(s) involved; tion of the drug produced with the (D) The manufacturing site(s) or manufacturing change. The supple- area(s) affected; ment, if approved, may subsequently (E) A description of the methods used justify a reduced reporting category for and studies performed to assess the ef- the particular change because the use fects of the change; of the protocol for that type of change (F) The data derived from such stud- reduces the potential risk of an adverse ies; effect. A comparability protocol sup- (G) Appropriate documentation (for plement must be labeled ‘‘Prior Ap- example, updated master batch proval Supplement—Comparability records, specification sheets) including Protocol.’’ previously approved documentation (3) Changes requiring submission of a (with the changes highlighted) or ref- supplement at least 30 days prior to dis- erences to previously approved docu- tribution of the drug made using the mentation; change (moderate changes). (i) A supple- (H) For a natural product, a recom- ment must be submitted for any binant DNA-derived protein/ change in the drug, production process,

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quality controls, equipment, or facili- (B) Any of the information required ties that has a moderate potential to under paragraph (b)(3)(iv) of this sec- have an adverse effect on the identity, tion is missing. In this case, the appli- strength, quality, purity, or potency of cant must not distribute the drug made the drug as these factors may relate to using the change until the supplement the safety or effectiveness of the drug. has been amended to provide the miss- (ii) These changes include, but are ing information. not limited to: (vi) The agency may designate a cat- (A) A change in the container closure egory of changes for the purpose of pro- system that does not affect the quality viding that, in the case of a change in of the drug except as otherwise de- such category, the holder of an ap- scribed in paragraphs (b)(2) and (b)(4) of proved application may commence dis- this section; tribution of the drug involved upon re- (B) Changes solely affecting a natural ceipt by the agency of a supplement for protein, a recombinant DNA-derived the change. The information listed in protein/polypeptide or a complex or paragraphs (b)(2)(iii)(A) through conjugate of a drug substance with a (b)(2)(iii)(J) of this section must be monoclonal antibody, including: contained in the supplement. The supplement must be labeled ‘‘Supplement- (1) An increase or decrease in produc- Changes Being Effected.’’ These tion scale during finishing steps that changes include, but are not limited to: involves different equipment, and (A) Addition to a specification or ( ) Replacement of equipment with 2 changes in the methods or controls to that of a different design that does not provide increased assurance that the affect the process methodology or proc- drug will have the characteristics of ess operating parameters. identity, strength, quality, purity, or (C) Relaxation of an acceptance cri- potency that it purports or is rep- terion or deletion of a test to comply resented to possess; and with an official compendium that is (B) A change in the size and/or shape consistent with FDA statutory and reg- of a container for a nonsterile drug ulatory requirements. product, except for solid dosage forms, (iii) A supplement submitted under without a change in the labeled paragraph (b)(3)(i) or (b)(3)(vi) of this amount of drug product or from one section is required to give a full expla- container closure system to another. nation of the basis for the change and (vii) If the agency disapproves the identify the date on which the change supplemental application, it may order is made. The supplement submitted the manufacturer to cease distribution under paragraph (b)(3)(i) must be la- of the drug(s) made with the manufac- beled ‘‘Supplement-Changes Being Ef- turing change. fected in 30 Days.’’ (4) Changes and updated stability data (iv) Pending approval of the supple- to be described and submitted in an an- ment by FDA and except as provided in nual report (minor changes). (i) Changes paragraph (b)(3)(vi) of this section, dis- in the drug, production process, quality tribution of the drug made using the controls, equipment, or facilities that change may begin not less than 30 days have a minimal potential to have an after receipt of the supplement by adverse effect on the identity, FDA. The information listed in para- strength, quality, purity, or potency of graphs (b)(2)(iii)(A) through the drug as these factors may relate to (b)(2)(iii)(J) of this section must be the safety or effectiveness of the drug contained in the supplement. must be documented by the applicant (v) The applicant must not distribute in an annual report to the application the drug made using the change if as described under paragraph (a)(2)(iii) within 30 days following FDA’s receipt of this section. The report must be la- of the supplement, FDA informs the beled ‘‘Minor Changes and Stability applicant that either: Report.’’ (A) The change requires approval (ii) These changes include but are not prior to distribution of the drug in ac- limited to: cordance with paragraph (b)(2) of this (A) Any change made to comply with section; or a change to an official compendium,

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except a change in paragraph (F) Data from studies and tests per- (b)(3)(ii)(C) of this section, that is con- formed to assess the effects of the sistent with FDA statutory and regu- change; latory requirements; (G) For a natural product, recom- (B) The deletion or reduction of an binant DNA-derived protein/ ingredient intended to affect only the polypeptide, complex or conjugate of a color of the drug product; drug substance with a monoclonal anti- (C) Replacement of equipment with body, sterilization process or test that of the same design and operating methodology related to sterilization principles except for those equipment process validation, relevant validation changes described in paragraph protocols and/or standard operating (b)(3)(ii)(B)(2) of this section; procedures; (D) A change in the size and/or shape (H) Appropriate documentation (for of a container containing the same example, updated master batch number of dosage units for a nonsterile records, specification sheets, etc.) in- solid dosage form drug product, with- cluding previously approved docu- out a change from one container clo- mentation (with the changes high- sure system to another; lighted) or references to previously ap- (E) A change within the container proved documentation; closure system for a nonsterile drug (I) Updated stability data generated product, based upon a showing of on commercial or production batches equivalency to the approved system according to an approved stability pro- under a protocol approved in the appli- tocol or commitment; and cation or published in an official com- (J) Any other information as directed pendium; by FDA. (F) An extension of an expiration (c) Labeling and other changes to an dating period based upon full shelf-life approved application—(1) General provi- data on production batches obtained sions. The applicant must notify FDA from a protocol approved in the appli- about each change in each condition cation; established in an approved application (G) The addition or revision of an al- beyond the variations already provided ternative analytical procedure that for in the application. The notice is re- provides the same or increased assur- quired to describe the change fully. ance of the identity, strength, quality, (2) Labeling changes requiring the sub- purity, or potency of the drug being mission and approval of a supplement tested as the analytical procedure de- prior to distribution of the drug made scribed in the approved application, or using the change (major changes). (i) Ad- deletion of an alternative analytical dition of intended uses and changes to procedure; and package labeling require a supplement. (H) The addition by embossing, de- These changes include, but are not lim- bossing, or engraving of a code imprint ited to: to a solid oral dosage form drug prod- (A) Revision in labeling, such as up- uct other than a modified release dos- dating information pertaining to ef- age form, or a minor change in an ex- fects, dosages, adverse reactions, con- isting code imprint. traindications, which includes informa- (iii) For changes under this category, tion headed ‘‘adverse reactions,’’ the applicant is required to submit in ‘‘warnings,’’ ‘‘precautions,’’ and ‘‘con- the annual report: traindications,’’ except ones described (A) A completed Form FDA 356V; in (c)(3) of this section; (B) A statement by the holder of the (B) Addition of an intended use; approved application that the effects of (C) If it is a prescription drug, any the change have been assessed; mailing or promotional piece used (C) A detailed description of the after the drug is placed on the market change(s); is labeling requiring a supplemental (D) The manufacturing site(s) or application, unless: area(s) involved; (1) The parts of the labeling fur- (E) The date each change was imple- nishing directions, warnings, and infor- mented; mation for use of the drug are the same

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in language and emphasis as labeling the supplement, ‘‘Supplement—Label- approved or permitted; and ing Changes Being Effected’’; (2) Any other parts of the labeling (B) Two sets of printed copies of any are consistent with and not contrary to revised labeling to be placed in use, such approved or permitted labeling. identified with the new animal drug ap- (3) Prescription drug labeling not re- plication number; and quiring an approved supplemental ap- (C) A statement by the applicant plication is submitted in accordance that all promotional labeling and all with § 514.80(b)(5)(ii). drug advertising will promptly be re- (D) Any other changes in labeling, vised consistent with the changes made except ones described in paragraph in the labeling on or within the new (c)(3) of this section. animal drug package no later than (ii) The applicant must obtain ap- upon approval of the supplemental approval of the supplement from FDA plication. prior to distribution of the drug. The (iv) If the supplemental application supplement must contain the fol- is not approved and the drug is being lowing: distributed with the proposed labeling, (A) A completed Form FDA 356V; FDA may initiate an enforcement ac- (B) A detailed description of the pro- tion because the drug is misbranded posed change; under section 502 of the act and/or (C) The drug(s) involved; adulterated under section 501 of the (D) The data derived from studies in act. In addition, under section 512(e) of support of the change; and the act, FDA may, after due notice and (E) Any other information as di- opportunity for a hearing, issue an rected by FDA. order withdrawing approval of the ap- (3) Labeling changes to be placed into plication. effect prior to receipt of a written notice of approval of a supplemental application. (4) Changes providing for additional (i) Labeling changes of the following distributors to be reported under Records kinds that increase the assurance of and reports concerning experience with drug safety proposed in supplemental approved new animal drugs (§ 514.80). applications must be placed into effect Supplemental applications as described immediately: under paragraph (c)(2) of this section (A) The addition to package labeling, will not be required for an additional promotional labeling, or prescription distributor to distribute a drug that is drug advertising of additional warning, the subject of an approved new animal contraindication, adverse reaction, and drug application or abbreviated new precaution information; animal drug application if the condi- (B) The deletion from package label- tions described under § 514.80(b)(5)(iii) ing, promotional labeling, or drug ad- are met. vertising of false, misleading, or unsup- (d) Patent information. The applicant ported intended uses or claims for ef- must comply with the patent informa- fectiveness; and tion requirements under section (C) Any other changes as directed by 512(c)(3) of the act. FDA. (e) Claimed exclusivity. If an applicant (ii) Labeling changes (for example, claims exclusivity under section design and style) that do not decrease 512(c)(2)(F) of the act upon approval of safety of drug use proposed in supple- a supplemental application for a mental applications may be placed into change in its previously approved drug, effect prior to written notice of ap- the applicant must include such a proval from FDA of a supplemental ap- statement. plication. (f) Good laboratory practice for nonclin- (iii) A supplement submitted under ical laboratory studies. A supplemental paragraph (c)(3) of this section must in- application that contains nonclinical clude the following information: laboratory studies must include, with (A) A full explanation of the basis for respect to each nonclinical study, ei- the changes, the date on which such ther a statement that the study was changes are being effected, and plainly conducted in compliance with the re- marked on the mailing cover and on quirements set forth in part 58 of this

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chapter, or, if the study was not con- mation submitted with or incorporated ducted in compliance with such regula- by reference in the NADA file. Such tions, a brief statement of the reason summaries do not constitute the full for the noncompliance. reports of investigations under section [71 FR 74782, Dec. 13, 2006] 512(b)(1) of the act (21 U.S.C. 360b(b)(1)) on which the safety or effectiveness of § 514.11 Confidentiality of data and in- the drug may be approved. Such sum- formation in a new animal drug ap- maries shall consist of the following: plication file. (i) For an NADA approved prior to (a) For purposes of this section the July 1, 1975, internal agency records NADA file includes all data and infor- that describe such data and informa- mation submitted with or incorporated tion, e.g., a summary of basis for ap- by reference in the NADA, INAD’s in- proval or internal reviews of the data corporated into the NADA, supple- and information, after deletion of: mental NADA’s, reports under §§ 514.80 (a) Names and any information that and 510.301 of this chapter, master files, would identify the investigators. and other related submissions. The (b) Any inappropriate gratuitous availability for public disclosure of any comments unnecessary to an objective record in the NADA file shall be han- analysis of the data and information. dled in accordance with the provisions (ii) For an NADA approved after July of this section. 1, 1975, a summary of such data and in- (b) The existence of an NADA file formation prepared in one of the fol- will not be disclosed by the Food and lowing two alternative ways shall be Drug Administration before the appli- publicly released when the application cation has been approved, unless it has is approved. been previously disclosed or acknowl- (a) The Center for Veterinary Medi- edged. cine may at an appropriate time prior (c) If the existence of an NADA file to approval of the NADA require the has not been publicly disclosed or ac- applicant to prepare a summary of knowledged, no data or information in such data and information, which will the NADA file is available for public be reviewed and, where appropriate, re- disclosure. vised by the Center. (d) If the existence of an NADA file (b) The Center for Veterinary Medi- has been publicly disclosed or acknowl- cine may prepare its own summary of edged before the application has been such data and information. approved, no data or information con- (3) A protocol for a test or study, un- tained in the file is available for public less it is shown to fall within the ex- disclosure, but the Commissioner may, emption established for trade secrets in his discretion, disclose a summary of and confidential commercial informa- such selected portions of the safety and tion in § 20.61 of this chapter. effectiveness data as are appropriate for public consideration of a specific (4) Adverse reaction reports, product pending issue, i.e., at an open session of experience reports, consumer com- a Food and Drug Administration advi- plaints, and other similar data and in- sory committee or pursuant to an ex- formation, after deletion of: change of important regulatory infor- (i) Names and any information that mation with a foreign government. would identify the person using the (e) After an application has been ap- product. proved, the following data and informa- (ii) Names and any information that tion in the NADA file are immediately would identify any third party involved available for public disclosure unless with the report, such as a physician, extraordinary circumstances are hospital, or other institution. shown: (5) A list of all active ingredients and (1) All safety and effectiveness data any inactive ingredients previously and information previously disclosed to disclosed to the public as defined in the public, as defined in § 20.81 of this § 20.81 of this chapter. chapter. (6) An assay method or other analyt- (2) A summary or summaries of the ical method, unless it serves no regu- safety and effectiveness data and infor- latory or compliance purpose and is

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shown to fall within the exemption es- the animal drug for identity, stability, tablished in § 20.61 of this chapter. purity, potency, and bioavailability. (7) All correspondence and written [40 FR 13825, Mar. 27, 1975, as amended at 42 summaries of oral discussions relating FR 3109, Jan. 14, 1977; 42 FR 15675, Mar. 22, to the NADA, in accordance with the 1977; 54 FR 18280, Apr. 28, 1989; 68 FR 15365, provisions of part 20 of this chapter. Mar. 31, 2003; 79 FR 14611, Mar. 17, 2014] (f) All safety and effectiveness data and information not previously dis- § 514.12 Confidentiality of data and in- closed to the public are available for formation in an investigational new public disclosure at the time any one of animal drug notice. the following events occurs unless ex- (a) The existence of an INAD notice traordinary circumstances are known: will not be disclosed by the Food and (1) The NADA has been abandoned Drug Administration unless it has pre- and no further work is being under- viously been publicly disclosed or ac- taken with respect to it. knowledged. (2) A final determination is made (b) The availability for public disclo- that the NADA is not approvable, and sure of all data and information in an all legal appeals have been exhausted. INAD file shall be handled in accord- (3) Approval of the NADA is with- ance with provisions established in drawn, and all legal appeals have been § 514.11. exhausted. (4) A final determination has been § 514.15 Untrue statements in applica- made that the animal drug is not a new tions. animal drug. Among the reasons why an applica- (5) A final determination has been tion for a new animal drug or animal made that the animal drug may be feed bearing or containing a new ani- marketed without submission of such mal drug may contain an untrue state- safety and/or effectiveness data and in- ment of a material fact are: formation. (a) Differences in: (g) The following data and informa- (1) Conditions of use prescribed, rection in an NADA file are not available ommended, or suggested by the appli- for public disclosure unless they have cant for the product from the condi- been previously disclosed to the public tions of such use stated in the applica- as defined in § 20.81 of this chapter or tion; they relate to a product or ingredient (2) Articles used as components of that has been abandoned and they no the product from those listed in the ap- longer represent a trade secret or con- plication; fidential commercial or financial infor- (3) Composition of the product from mation as defined in § 20.61 of this chap- that stated in the application; ter: (4) Methods used in or the facilities (1) Manufacturing methods or proc- and controls used for the manufacture, esses, including quality control proce- processing, or packing of the product dures. from such methods, facilities, and con- (2) Production, sales, distribution, trols described in the application; and similar data and information, ex- (5) Labeling from the specimens con- cept that any compilation of such data tained in the application; or and information aggregated and pre- (b) The unexplained omission in pared in a way that does not reveal whole or in part from an application or data or information which is not avail- from an amendment or supplement to able for public disclosure under this an application or from any record or provision is available for public disclo- report required under the provisions of sure. section 512 of the act and § 514.80 or (3) Quantitative or semiquantitative § 510.301 of this chapter of any informa- formulas. tion obtained from: (h) For purposes of this regulation, (1) Investigations as to the safety, ef- safety and effectiveness data include fectiveness, identity, strength, quality, all studies and tests of an animal drug or purity of the drug, made by the ap- on animals and all studies and tests on plicant on the drug, or

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(2) Investigations or experience with conducted in compliance with the good the product that is the subject of the laboratory practice regulations as set application, or any related product, forth in part 58 of this chapter, and the available to the applicant from any application fails to include a brief source if such information is pertinent statement of the reason for the non- to an evaluation of the safety, effec- compliance. tiveness, identity, strength, quality, or [40 FR 13825, Mar. 27, 1975, as amended at 49 purity of the drug, when such omission FR 7226, Feb. 28, 1984; 50 FR 7517, Feb. 22, would bias an evaluation of the safety 1985; 68 FR 15365, Mar. 31, 2003] or effectiveness of the product. (c) Any nonclinical laboratory study Subpart B—Administrative Actions contained in the application was not on Applications

§ 514.80 Records and reports concerning experience with approved new animal drugs. The following table outlines the purpose for each paragraph of this section:

Purpose 21 CFR Paragraph and Title

What information must be reported concerning approved NADAs or 514.80(a) Applicability. ANADAs?

What authority does FDA have for requesting records and reports? 514.80(a)(1). Who is required to establish, maintain, and report required information relating to experiences with a new animal drug? Is information from foreign sources required?

What records must be established and maintained and what reports filed 514.80(a)(2). with FDA?

What is FDA’s purpose for requiring reports? 514.80(a)(3).

Do applicants of Type A medicated articles have to establish, maintain, 514.80(a)(4). and report information required under § 514.80?

How do the requirements under § 514.80 relate to current good manufac- 514.80(a)(5). turing practices?

514.80(b) Reporting requirements.

What are the requirements for reporting product/manufacturing defects? 514.80(b)(1) Three-day NADA/ANADA field alert report.

514.80(b)(2) Fifteen-day NADA/ANADA alert report.

What are the requirements for reporting serious and unexpected adverse 514.80(b)(2)(i) Initial report. drug experiences?

What are the requirements for followup reporting of serious and unex- 514.80(b)(2)(ii) Followup report. pected adverse drug experiences?

What are the requirements for nonapplicants for reporting adverse drug 514.80(b)(3) Nonapplicant report. experiences?

What are the general requirements for submission of periodic drug experi- 514.80(b)(4) Periodic drug experience report. ence reports, e.g., forms to be submitted, submission date and frequency, when is it to be submitted, how many copies? How do I petition to change the date of submission or frequency of submissions?

What must be submitted in the periodic drug experience reports? 514.80(b)(4)(i) through (b)(4)(iv).

What distribution data must be submitted? 514.80(b)(4)(i) Distribution data. How should the distribution data be submitted?

What labeling materials should be submitted? 514.80(b)(4)(ii) Labeling. How do I report changes to the labeling materials since the last report?

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Purpose 21 CFR Paragraph and Title

514.80(b)(4)(iii) Nonclinical laboratory studies and clinical data not previously reported.

What are the requirements for submission of nonclinical laboratory stud- 514.80(b)(4)(iii)(A). ies?

What are the requirements for submission of clinical laboratory data? 514.80(b)(4)(iii)(B).

When must results of clinical trials conducted by or for the applicant be re- 514.80(b)(4)(iii)(C). ported?

514.80(b)(4)(iv) Adverse drug experiences.

How do I report product/manufacturing defects and adverse drug experi- 514.80(b)(4)(iv)(A). ences not previously reported to FDA?

What are the requirements for submitting adverse drug experiences cited 514.80(b)(4)(iv)(B). in literature?

What are the requirements for submitting adverse drug experiences in 514.80(b)(4)(iv)(C). postapproval studies and clinical trials?

What are the requirements for reporting increases in the frequency of seri- 514.80(b)(4)(v) Summary report of increased fre- ous, expected, and unexpected adverse drug experiences? quency of adverse drug experience.

514.80(b)(5) Other reporting.

Can FDA request that an applicant submit information at different times 514.80(b)(5)(i) Special drug experience report. than stated specifically in this regulation?

What are the requirements for submission of advertisement and pro- 514.80(b)(5)(ii) Advertisements and promotional la- motional labeling to FDA? beling.

What are the requirements for adding a new distributor to the approved 514.80(b)(5)(iii) Distributor’s statement. application?

What labels and how many labels need to be submitted for review? 514.80(b)(5)(iii)(A).

What changes are required and allowed to distributor labeling? 514.80(b)(5)(iii)(A)(1).

What are the requirements for making other changes to the distributor la- 514.80(b)(5)(iii)(A)(2). beling?

What information should be included in each new distributor’s signed 514.80(b)(5)(iii)(B)(1) through (b)(5)(iii)(B)(5). statement?

What are the conditions for submitting information that is common to more 514.80(c) Multiple applications. than one application? (i.e., can I submit common information to one application?)

What information has to be submitted to the common application and re- 514.80(c)(1) through (c)(4). lated application?

What forms do I need? 514.80(d) Reporting forms. What are Forms FDA 1932 and 2301? How can I get them? Can I use computer-generated equivalents?

How long must I maintain Form FDA 1932 and records and reports of 514.80(e) Records to be maintained. other required information, i.e., how long do I need to maintain this information?

What are the requirements for allowing access to these records and re- 514.80(f) Access to records and reports. ports, and copying by authorized FDA officer or employee?

How do I obtain Forms FDA 1932 and 2301? 514.80(g) Mailing addresses. Where do I mail FDA’s required forms, records, and reports?

What happens if the applicant fails to establish, maintain, or make the re- 514.80(h) Withdrawal of approval. quired reports? What happens if the applicant refuses to allow FDA access to, and/or copying and/or verify records and reports?

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Purpose 21 CFR Paragraph and Title

Does an adverse drug experience reflect a conclusion that the report or 514.80(i) Disclaimer. information constitutes an admission that the drug caused an adverse effect?

(a) Applicability. (1) Each applicant those required by the current good must establish and maintain indexed manufacturing practice regulations in and complete files containing full parts 211, 225, and 226 of this chapter. records of all information pertinent to (b) Reporting requirements—(1) Three- safety or effectiveness of a new animal day NADA/ANADA field alert report. drug that has not been previously sub- This report provides information permitted as part of the NADA or ANADA. taining to product and manufacturing Such records must include information defects that may result in serious ad- from domestic as well as foreign verse drug events. The applicant (or sources. Each nonapplicant must estab- nonapplicant through the applicant) lish and maintain indexed and com- must submit the report to the appro- plete files containing full records of all priate FDA District Office or local information pertinent to safety or ef- FDA resident post within 3 working fectiveness of a new animal drug that days of first becoming aware that a de- is received or otherwise obtained by fect may exist. The information ini- the nonapplicant. Such records must tially may be provided by telephone or include information from domestic as other telecommunication means, with well as foreign sources. prompt written followup using Form (2) Each applicant must submit re- FDA 1932 ‘‘Veterinary Adverse Drug ports of data, studies, and other infor- Reaction, Lack of Effectiveness, Prod- mation concerning experience with uct Defect Report.’’ The mailing cover new animal drugs to the Food and Drug for these reports must be plainly Administration (FDA) for each ap- marked ‘‘3-Day NADA/ANADA Field proved NADA and ANADA, as required Alert Report.’’ in this section. A nonapplicant must (2) Fifteen-day NADA/ANADA alert re- submit data, studies, and other infor- port—(i) Initial report. This report pro- mation concerning experience with vides information on each serious, un- new animal drugs to the appropriate expected adverse drug event, regardless applicant, as required in this section. of the source of the information. The The applicant, in turn, must report the applicant (or nonapplicant through the nonapplicant’s data, studies, and other applicant) must submit the report to information to FDA. Applicants and FDA within 15 working days of first re- nonapplicants must submit data, stud- ceiving the information. The report ies, and other information described in must be submitted on Form FDA 1932, this section from domestic, as well as and its mailing cover must be plainly foreign sources. marked ‘‘15-Day NADA/ANADA Alert (3) FDA reviews the records and re- Report.’’ ports required in this section to facili- (ii) Followup report. The applicant tate a determination under section must promptly investigate all adverse 512(e) of the Federal Food, Drug, and drug events that are the subject of 15- Cosmetic Act (21 U.S.C. 360b(e)) as to day NADA/ANADA alert reports. If this whether there may be grounds for sus- investigation reveals significant new pending or withdrawing approval of the information, a followup report must be NADA or ANADA. submitted within 15 working days of (4) The requirements of this section receiving such information. A followup also apply to any approved Type A report must be submitted on Form medicated article. In addition, the re- FDA 1932, and its mailing cover must quirements contained in § 514.80(b)(1), be plainly marked ‘‘15-Day NADA/ (b)(2), (b)(4)(iv), and (b)(4)(v) apply to ANADA Alert Report Followup.’’ The any approved Type A medicated article followup report must state the date of incorporated in animal feeds. the initial report and provide the addi- (5) The records and reports referred tional information. If additional infor- to in this section are in addition to mation is sought but not obtained

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within 3 months of the initial report, a tion on any distributor-labeled prod- followup report is required describing uct. This information must include the the steps taken and why additional in- total number of distributed units of formation was not obtained. each size, strength, or potency (e.g., (3) Nonapplicant report. Nonapplicants 100,000 bottles of 100 5-milligram tab- must forward reports of adverse drug lets; 50,000 10-milliliter vials of 5-per- experiences to the applicant within 3 cent solution). This information must working days of first receiving the in- be presented in two categories: Quan- formation. The applicant must then tities distributed domestically and submit the report(s) to FDA as re- quantities exported. quired in this section. The non- (B) Applicants submitting annual applicant must maintain records of all sales and distribution reports for anti- nonapplicant reports, including the microbial new animal drug products date the nonapplicant received the in- under § 514.87 have the option not to re- formation concerning adverse drug export distribution data under paragraph periences, the name and address of the (b)(4)(i)(A) of this section for the ap- applicant, and a copy of the adverse proved applications that include these drug experience report including the same products, but only provided each date such report was submitted to the of the following conditions are met: applicant. If the nonapplicant elects to (1) Applicants must have submitted also report directly to FDA, the non- complete periodic drug experience re- applicant should submit the report on ports under this section for such appli- Form FDA 1932 within 15 working days cations for at least 2 full years after of first receiving the information. the date of their initial approval. (4) Periodic drug experience report. (2) Applicants must ensure that the This report must be accompanied by a beginning of the reporting period for completed Form FDA 2301 ‘‘Trans- the annual periodic drug experience re- mittal of Periodic Reports and Pro- ports for such applications is January motional Materials for New Animal 1. For applications that currently have Drugs.’’ It must be submitted every 6 a reporting period that begins on a months for the first 2 years following date other than January 1, applicants approval of an NADA or ANADA and must request a change in reporting yearly thereafter. Reports required by submission date such that the report- this section must contain data and in- ing period begins on January 1 and formation for the full reporting period. ends on December 31, as described in The 6-month periodic drug experience paragraph (b)(4) of this section. reports must be submitted within 30 (3) Applicants that change their re- days following the end of the 6-month porting submission date must also sub- reporting period. The yearly periodic mit a special drug experience report, as drug experience reports must be sub- described in paragraph (b)(5)(i) of this mitted within 90 days of the anniver- section, that addresses any gaps in dis- sary date of the approval of the NADA tribution data caused by the change in or ANADA. Any previously submitted date of submission. information contained in the report (4) Applicants who choose not to re- must be identified as such. For yearly port under paragraph (b)(4)(i)(A) of this (annual) periodic drug experience re- section must ensure that full sales and ports, the applicant may petition FDA distribution data for each product ap- to change the date of submission or fre- proved under such applications are al- quency of reporting, and after approval ternatively reported under § 514.87, in- of such petition, file such reports on cluding products that are labeled for the new filing date or at the new re- use only in nonfood-producing animals. porting frequency. Also, FDA may re- (ii) Labeling. Applicant and dis- quire a report at different times or tributor current package labeling, in- more frequently. The periodic drug excluding package inserts (if any). For perience report must contain the fol- large-size package labeling or large lowing: shipping cartons, a representative copy (i) Distribution data. (A) Information must be submitted (e.g., a photocopy of about the distribution of each new ani- pertinent areas of large feed bags). A mal drug product, including informa- summary of any changes in labeling

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made since the last report (listed by (expected and unexpected) adverse drug date of implementation) must be in- events. The applicant must evaluate cluded with the labeling or if there the increased frequency of serious (ex- have been no changes, a statement of pected or unexpected) adverse drug such fact must be included with the la- events at least as often as reporting of beling. periodic drug experience reports. The (iii) Nonclinical laboratory studies applicant must report the increased and clinical data not previously re- frequency of serious (expected and un- ported. expected) adverse drug events in the (A) Copies of in vitro studies (e.g., periodic drug experience report. Sum- mutagenicity) and other nonclinical maries of reports of increased fre- laboratory studies conducted by or oth- quency of adverse drug events must be erwise obtained by the applicant. submitted in narrative form. The sum- (B) Copies of published clinical trials maries must state the time period on of the new animal drug (or abstracts of which the increased frequency is based, them) including clinical trials on safe- time period comparisons in deter- ty and effectiveness, clinical trials on mining increased frequency, references new uses, and reports of clinical experi- to any previously submitted Form FDA ence pertinent to safety conducted by 1932, the method of analysis, and the or otherwise obtained by the applicant. interpretation of the results. The sum- Review articles, papers, and abstracts maries must be submitted in a separate in which the drug is used as a research section within the periodic drug experi- tool, promotional articles, press clip- ence report. pings, and papers that do not contain (5) Other reporting—(i) Special drug ex- tabulations or summaries of original perience report. Upon written request, data are not required to be reported. FDA may require that the applicant (C) Descriptions of completed clinical submit a report required under § 514.80 trials conducted by or for the applicant at different times or more frequently must be submitted no later than 1 year than the timeframes stated in § 514.80. after completion of research. Sup- (ii) Advertisements and promotional la- porting information is not to be re- beling. The applicant must submit at ported. the time of initial dissemination one (iv) Adverse drug experiences. (A) set of specimens of mailing pieces and Product/manufacturing defects and ad- other labeling for prescription and verse drug experiences not previously over-the-counter new animal drugs. reported under § 514.80(b)(1) and (b)(2) For prescription new animal drugs, the must be reported individually on Form applicant must also submit one set of FDA 1932. specimens of any advertisement at the (B) Reports of adverse drug experi- time of initial publication or broad- ences in the literature must be noted cast. Mailing pieces and labeling de- in the periodic drug experience report. signed to contain product samples A bibliography of pertinent references must be complete except that product must be included with the report. Upon samples may be omitted. Each submis- FDA’s request, the applicant must pro- sion of promotional labeling or adver- vide a full text copy of these publica- tisements must be accompanied by a tions. completed Form FDA 2301. (C) Reports of previously not re- (iii) Distributor’s statement. At the ported adverse drug experiences that time of initial distribution of a new occur in postapproval studies must be animal drug product by a distributor, reported separately from other experi- the applicant must submit a special ences in the periodic drug experience drug experience report accompanied by report and clearly marked or high- a completed Form FDA 2301 containing lighted. the following: (v) Summary report of increased fre- (A) The distributor’s current product quency of adverse drug experience. The labeling. applicant must periodically review the (1) The distributor’s labeling must be incidence of reports of adverse drug ex- identical to that in the approved periences to determine if there has NADA/ANADA except for a different been an increased frequency of serious and suitable proprietary name (if used)

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and the name and address of the dis- for the complete report of the common tributor. The name and address of the information. distributor must be preceded by an ap- (4) All other information specific to a propriate qualifying phrase as per- particular NADA/ANADA must be in- mitted by the regulations such as cluded in the report for that particular ‘‘manufactured for’’ or ‘‘distributed NADA/ANADA. by.’’ (d) Reporting forms. Applicant must (2) Other labeling changes must be report adverse drug experiences and the subject of a supplemental NADA or product/manufacturing defects on ANADA as described under § 514.8. Form FDA 1932, ‘‘Veterinary Adverse (B) A signed statement by the dis- Drug Reaction, Lack of Effectiveness, tributor stating: Product Defect Report.’’ Periodic drug (1) The category of the distributor’s experience reports and special drug ex- operations (e.g., wholesale or retail), perience reports must be accompanied (2) That the distributor will dis- by a completed Form FDA 2301 tribute the new animal drug only under ‘‘Transmittal of Periodic Reports and the approved labeling, Promotional Material for New Animal (3) That the distributor will promote Drugs,’’ in accordance with directions the product only for use under the con- provided on the forms. Computer-gen- ditions stated in the approved labeling, erated equivalents of Form FDA 1932 or (4) That the distributor will adhere Form FDA 2301, approved by FDA be- to the records and reports require- fore use, may be used. Form FDA 1932 ments of this section, and and Form FDA 2301 may be obtained on (5) That the distributor is regularly the Internet at http://www.fda.gov/cvm/ and lawfully engaged in the distribu- forms/forms.html, by telephoning the Di- tion or dispensing of prescription prod- vision of Surveillance (HFV–210), or by ucts if the product is a prescription submitting a written request to the fol- new animal drug. lowing address: Food and Drug Admin- (c) Multiple applications. Whenever an istration, Center for Veterinary Medi- applicant is required to submit a peri- cine, Division of Surveillance (HFV– odic drug experience report under the 210), 7500 Standish Pl., Rockville, MD provisions of § 514.80(b)(4) with respect 20855–2764. to more than one approved NADA or (e) Records to be maintained. The ap- ANADA for preparations containing plicants and nonapplicants must main- the same new animal drug so that the tain records and reports of all informa- same information is required to be re- tion required by this section for a pe- ported for more than one application, riod of 5 years after the date of submis- the applicant may elect to submit as a sion. part of the report for one such applica- (f) Access to records and reports. The tion (the primary application) all the applicant and nonapplicant must, upon information common to such applica- request from any authorized FDA offi- tions in lieu of reporting separately cer or employee, at all reasonable and repetitively on each. If the appli- times, permit such officer or employee cant elects to do this, the applicant to have access to copy and to verify all must do the following: such required records and reports. (1) State when a report applies to (g) Mailing addresses. Completed 15- multiple applications and identify all day alert reports, periodic drug experi- related applications for which the re- ence reports, and special drug experi- port is submitted by NADA or ANADA ence reports must be submitted to the number. following address: Food and Drug Ad- (2) Ensure that the primary applica- ministration, Center for Veterinary tion contains a list of the NADA or Medicine, Document Control Unit ANADA numbers of all related applica- (HFV–199), 7500 Standish Pl., Rockville, tions. MD 20855–2764. Three-day alert reports (3) Submit a completed Form FDA must be submitted to the appropriate 2301 to the primary application and FDA district office or local FDA resi- each related application with reference dent post. Addresses for district offices to the primary application by NADA/ and resident posts may be obtained ANADA number and submission date from the Internet at http://www.fda.gov

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(click on ‘‘Contact FDA,’’ then ‘‘FDA (1) A listing of each antimicrobial ac- Field Offices’’). tive ingredient contained in the prod- (h) Withdrawal of approval. If FDA uct; finds that the applicant has failed to (2) A description of each product sold establish the required records, or has or distributed by unit, including the failed to maintain those records, or container size, strength, and dosage failed to make the required reports, or form of such product units; has refused access to an authorized (3) For each such product, a listing of FDA officer or employee to copy or to the target animal species, indications, verify such records or reports, FDA and production classes that are speci- may withdraw approval of the applica- fied on the approved label; tion to which such records or reports (4) For each such product, the num- relate. If FDA determines that with- ber of units sold or distributed in the drawal of the approval is necessary, the United States (i.e., domestic sales) for agency shall give the applicant notice each month of the reporting year; and and opportunity for hearing, as provided in § 514.200, on the question of (5) For each such product, the num- whether to withdraw approval of the ber of units sold or distributed outside application. the United States (i.e., quantities ex- (i) Disclaimer. Any report or informa- ported) for each month of the reporting tion submitted under this section and year. any release of that report or informa- (c) Each report must also provide a tion by FDA will be without prejudice species-specific estimate of the per- and does not necessarily reflect a con- centage of each product described in clusion that the report or information paragraph (b)(2) of this section that constitutes an admission that the drug was sold or distributed domestically in caused or contributed to an adverse the reporting year for use in any of the event. A person need not admit, and following animal species categories, may deny, that the report or informa- but only for such species that appear tion constitutes an admission that a on the approved label: Cattle, swine, drug caused or contributed to an ad- chickens, turkeys. The total of the spe- verse event. cies-specific percentages reported for each product must account for 100 per- [68 FR 15365, Mar. 31, 2003, as amended at 81 cent of its sales and distribution; FR 29141, May 11, 2016] therefore, a fifth category of ‘‘other § 514.87 Annual reports for anti- species/unknown’’ must also be re- microbial animal drug sales and ported. distribution. (d) Each report must: (a) The applicant for each new ani- (1) Be submitted not later than mal drug product approved under sec- March 31 each year; tion 512 of the Federal Food, Drug, and (2) Cover the period of the preceding Cosmetic Act, or conditionally ap- calendar year; and proved under section 571 of the Federal (3) Be submitted using Form FDA Food, Drug, and Cosmetic Act, and 3744, ‘‘Antimicrobial Animal Drug Dis- containing an antimicrobial active in- tribution Report.’’ gredient, must submit an annual report (e) Sales and distribution data and to FDA on the amount of each such information reported under this sec- antimicrobial active ingredient in the tion will be considered to fall within drug that is sold or distributed in the the exemption for confidential com- reporting year for use in food-pro- mercial information established in ducing animal species, including infor- § 20.61 of this chapter and will not be mation on any distributor-labeled publicly disclosed, except that sum- product. mary reports of such information ag- (b) This report must identify the ap- gregated in such a way that does not proved or conditionally approved appli- reveal information that is not avail- cation and must include the following able for public disclosure under this information for each new animal drug provision will be prepared by FDA and product described in paragraph (a) of made available to the public as pro- this section: vided in paragraph (f) of this section.

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(f) FDA will publish an annual sum- are received. If the samples are not re- mary report of the data and informa- ceived within 90 days after the request, tion it receives under this section for the application will be considered with- each calendar year by December 31 of drawn without prejudice. the following year. Such annual re- (d) The information contained in an ports must include a summary of sales application may be insufficient to de- and distribution data and information termine whether a new animal drug is by antimicrobial drug class and may safe or effective in use if it fails to in- include additional summary data and clude (among other things) a statement information as determined by FDA. In showing whether such drug is to be order to protect confidential commer- limited to prescription sale and exempt cial information, each individual under section 502(f) of the act from the datum appearing in the summary re- requirement that its labeling bear ade- port must: quate directions for lay use. If such (1) Reflect combined product sales drug is to be exempt, the information and distribution data and information may also be insufficient if: obtained from three or more distinct (1) The specimen labeling proposed sponsors of approved products that fails to bear adequate information for were actively sold or distributed that professional use including indications, reporting year, and effects, dosages, routes, methods, and (2) Be reported in a manner con- frequency and duration of administra- sistent with protecting both national tion and any relevant hazards, contra- security and confidential commercial indications, side effects, and pre- information. cautions under which practitioners li- [81 FR 29141, May 11, 2016] censed by law to administer such drug can use the drug for the purposes for § 514.100 Evaluation and comment on which it is intended, including all pur- applications. poses for which it is to be advertised, (a) After the filed application has or represented, in accordance with been evaluated, the applicant will be § 201.105 of this chapter, and informa- furnished written comment on any ap- tion concerning hazards, contraindica- parent deficiencies in the application. tions, side effects, and precautions rel- (b) When the description of the meth- evant with respect to any uses for ods used in, and the facilities and con- which such drug is to be prescribed. trols used for, the manufacture, proc- (2) The application fails to show that essing, and packing of such new animal the labeling and advertising of such drug appears adequate on its face, but drug will offer the drug for use only it is not feasible to reach a conclusion under those conditions for which it is as to the safety and effectiveness of the offered in the labeling that is part of new animal drug solely from consider- the application. ation of this description, the applicant (3) The application fails to show that may be notified that an establishment all labeling that furnishes or purports inspection is required to verify their to furnish information for professional adequacy. use of such drug will contain, in the (c) A request for samples of a new same language and emphasis, the infor- animal drug or any edible tissues and mation for use including indications, byproducts of animals treated with effects, dosages, routes, methods, and such a drug, shall specify the quantity frequency and duration of administra- deemed adequate to permit tests of an- tion and any relevant warnings, haz- alytical methods to determine their ards, contraindications, side effects, adequacy for regulatory purposes. The and precautions, which is contained in request should be made as early in the the labeling that is part of the applica- 180-day period as possible to assure tion in accordance with § 201.105 of this timely completion. The date used for chapter. computing the 180-day limit for the (e) The information contained in an purposes of section 512(c) of the act application will be considered insuffi- shall be moved forward 1 day for each cient to determine whether a new ani- day after the mailing date of the re- mal drug is safe and effective for use quest until all of the requested samples when there is a refusal or failure upon

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written notice to furnish inspectors au- filed pursuant to § 514.8, the Commis- thorized by the Food and Drug Admin- sioner shall approve the supplemental istration an adequate opportunity to application in accordance with proce- inspect the facilities, controls, and dures set forth in § 514.105(a)(1) and (2) records pertinent to the application. if he/she determines that the applica- (f) On the basis of preliminary con- tion satisfies the requirements of ap- sideration of an application or supple- plicable statutory provisions and regu- mental application containing type- lations. written or other draft labeling in lieu (b) The Commissioner will assign a of final printed labeling, an applicant supplemental application to its proper may be informed that such application category to ensure processing of the is approvable when satisfactory final application. printed labeling identical in content to (1) Category I. Supplements that ordi- such draft copy is submitted. narily do not require a reevaluation of (g) When an application has been any of the safety or effectiveness data found incomplete on the basis of a need in the parent application. Category I for the kind of information described supplements include the following: in § 514.6, such application shall be con- (i) A corporate change that alters the sidered withdrawn without prejudice to identity or address of the sponsor of future filing on the date of issuance of the new animal drug application the letter citing the inadequacies con- (NADA). tained in the application, unless within (ii) The sale, purchase, or construc- 30 days the sponsor chooses to avail tion of manufacturing facilities. himself of the opportunity for hearing (iii) The sale or purchase of an as prescribed by § 514.111. NADA. (iv) A change in container, container § 514.105 Approval of applications. style, shape, size, or components. (a) The Commissioner shall forward (v) A change in approved labeling for publication in the FEDERAL REG- (color, style, format, addition, dele- ISTER a regulation prescribing the con- tion, or revision of certain statements, ditions under which the new animal e.g., trade name, storage, expiration drug may be used, including the name dates, etc). and address of the applicant; the condi- (vi) A change in promotional mate- tions and indications for use covered rial for a prescription new animal drug by the application; any tolerance, not exempted by § 514.8(c)(2)(i)(C)(1) withdrawal period, or other use restric- through (c)(2)(i)(C)(3). tions; any tolerance required for the (vii) Changes in manufacturing proc- new animal drug substance or its me- esses that do not alter the method of tabolites in edible products of food-pro- manufacture or change the final dosage ducing animals; and, if such new ani- form. mal drug is intended for use in animal (viii) A change in bulk drug ship- feed, appropriate purposes and condi- ments. tions of use (including special labeling (ix) A change in an analytical meth- requirements) applicable to any animal od or control procedures that do not feed; and such other information the alter the approved standards. Commissioner deems necessary to as- (x) A change in an expiration date. sure safe and effective use. (xi) Addition of an alternate manu- (b) He shall notify the applicant by facturer, repackager, or relabeler of sending him a copy of the proposed the drug product. publication as described in paragraph (xii) Addition of an alternate supplier (a)(1) of this section. of the new drug substance. [40 FR 13825, Mar. 27, 1975, as amended at 51 (xiii) A change permitted in advance FR 7392, Mar. 3, 1986; 64 FR 63203, Nov. 19, of approval as described under 1999] § 514.8(b)(3). (2) Category II. Supplements that may § 514.106 Approval of supplemental ap- require a reevaluation of certain safety plications. or effectiveness data in the parent ap- (a) Within 180 days after a supple- plication. Category II supplements in- ment to an approved application is clude the following:

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(i) A change in the active ingredient § 514.110 Reasons for refusing to file concentration or composition of the applications. final product. (a) The date of receipt of an applica- (ii) A change in quality, purity, tion for a new animal drug shall be the strength, and identity specifications of date on which the application shall be the active or inactive ingredients. deemed to be filed. (iii) A change in dose (amount of (b) An application for a new animal drug administered per dose). drug shall not be considered acceptable (iv) A change in the treatment regi- for filing for any of the following rea- men (schedule of dosing). sons: (v) Addition of a new therapeutic (1) It does not contain complete and claim to the approved uses of the prod- accurate English translations of any uct. pertinent part in a foreign language. (2) Fewer than three copies are sub- (vi) Addition of a new or revised ani- mitted. mal production claim. (3) It is incomplete on its face in that (vii) Addition of a new species. it is not properly organized and in- (viii) A change in the prescription or dexed. over-the-counter status of a drug prod- (4) On its face the information con- uct. cerning required matter is so inad- (ix) A change in statements regard- equate that the application is clearly ing side effects, warnings, precautions, not approvable. and contraindications, except the addi- (5) The new animal drug is to be man- tion of approved statements to con- ufactured, prepared, propagated, com- tainer, package, and promotional label- pounded, or processed in whole or in ing, and prescription drug advertising. part in any State in an establishment (x) A change in the drug withdrawal that has not been registered or exempt- period prior to slaughter or in the milk ed from registration under the provi- discard time. sions of section 510 of the act. (xi) A change in the tolerance for (6) The sponsor does not reside or drug residues. maintain a place of business within the (xii) A change in analytical methods United States and the application has for drug residues. not been countersigned by an attorney, (xiii) A revised method of synthesis agent, or other representative of the or fermentation of the new drug sub- applicant, which representative resides stance. in the United States and has been duly (xiv) Updating or changes in the authorized to act on behalf of the ap- manufacturing process of the new drug plicant and to receive communications substance and/or final dosage form on all matters pertaining to the appli- (other than a change in equipment that cation. (7) The new animal drug is a drug does not alter the method of manufac- subject to licensing under the animal ture of a new animal drug, or a change virus, serum, and toxin law of March 4, from one commercial batch size to an- 1913 (37 Stat. 832; 21 U.S.C. 151 et seq. ). other without any change in manufac- Such applications will be referred to turing procedure), or changes in the the U.S. Department of Agriculture for methods, facilities, or controls used for action. the manufacture, processing, pack- (8) It fails to include, with respect to aging, or holding of the new animal each nonclinical laboratory study con- drug (other than use of an establish- tained in the application, either a ment not covered by the approval that statement that the study was con- is in effect) that give increased assur- ducted in compliance with the good ance that the drug will have the char- laboratory practice regulations set acteristics of identity, strength, qual- forth in part 58 of this chapter, or, if ity, and purity which it purports or is the study was not conducted in compli- represented to possess. ance with such regulations, a brief [55 FR 46052, Nov. 1, 1990; 55 FR 49973, Dec. 3, statement of the reasons for the non- 1990; 56 FR 12422, Mar. 25, 1991; 71 FR 74785, compliance. Dec. 13, 2006] (9) [Reserved]

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(10) The applicant fails to submit a tion before it with respect to such complete environmental assessment drug, it has insufficient information to under § 25.40 of this chapter or fails to determine whether such drug is safe for provide sufficient information to estab- use under such conditions. In making lish that the requested action is sub- this determination the Commissioner ject to categorical exclusion under shall consider, among other relevant § 25.30 or § 25.33 of this chapter. factors: (c) If an application is determined (i) The probable consumption of such not to be acceptable for filing, the ap- drug and of any substance formed in or plicant shall be notified within 30 days on food because of the use of such drug; of receipt of the application and shall (ii) The cumulative effect on man or be given the reasons therefore. animal of such drug, taking into ac- (d) If the applicant disputes the findings that his application is not accept- count any chemically or pharmacologi- able for filing, he may make written cally related substances; request that the application be filed (iii) Safety factors which, in the over protest, in which case it will be opinion of experts qualified by sci- filed as of the day originally received. entific training and experience to evaluate the safety of such drugs, are [40 FR 13825, Mar. 27, 1975, as amended at 50 appropriate for the use of animal ex- FR 7517, Feb. 22, 1985; 50 FR 16668, Apr. 26, 1985; 62 FR 40600, July 29, 1997] perimentation data; and (iv) Whether the conditions of use § 514.111 Refusal to approve an appli- prescribed, recommended, or suggested cation. in the proposed labeling are reasonably (a) The Commissioner shall, within certain to be followed in practice; or 180 days after the filing of the applica- (5) Evaluated on the basis of information, inform the applicant in writing of tion submitted as part of the applica- his intention to issue a notice of oppor- tion and any other information before tunity for a hearing on a proposal to the Food and Drug Administration refuse to approve the application, if the with respect to such drug, there is lack Commissioner determines upon the of substantial evidence as defined in basis of the application, or upon the § 514.4. basis of other information before him (6) Failure to include an appropriate with respect to a new animal drug, proposed tolerance for residues in edi- that: ble products derived from animals or a (1) The reports of investigations re- withdrawal period or other restrictions quired to be submitted pursuant to sec- for use of such drug if any tolerance or tion 512(b) of the act do not include withdrawal period or other restrictions adequate tests by all methods reason- for use are required in order to assure ably applicable to show whether or not that the edible products derived from such drug is safe for use under the con- animals treated with such drug will be ditions prescribed, recommended, or safe. suggested in the proposed labeling (7) Based on a fair evaluation of all thereof; or material facts, the labeling is false or (2) The results of such tests show misleading in any particular; or that such drug is unsafe for use under such conditions or do not show that (8) Such drug induces cancer when in- such drug is safe for use under such gested by man or animal or, after ap- conditions; or propriate tests for evaluation of the (3) The methods used in and the fa- safety of such drug, induces cancer in cilities and controls used for the manu- man or animal, except that this sub- facture, processing, and packing of paragraph shall not apply with respect such drug are inadequate to preserve to such drug if the Commissioner finds its identity, strength, quality, and pu- that, under the conditions of use speci- rity; or fied in proposed labeling and reason- (4) Upon the basis of the information ably certain to be followed in practice: submitted to the Food and Drug Ad- (i) Such drug will not adversely af- ministration as part of the application, fect the animal for which it is in- or upon the basis of any other informa- tended; and

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(ii) No residue of such drug will be (3) Agrees with the Commissioner on found (by methods of examination pre- an additional period to precede scribed or approved by the Commis- issuance of such notice of hearing. sioner by regulations) in any edible [40 FR 13825, Mar. 27, 1975, as amended at 43 portion of such animal after slaughter FR 22675, May 26, 1978; 44 FR 16007, Mar. 16, or in any food yielded by, or derived 1979; 50 FR 7517, Feb. 22, 1985; 50 FR 16668, from the living animals. Apr. 26, 1985; 52 FR 49588, Dec. 31, 1987; 54 FR (9) The applicant fails to submit an 18280, Apr. 28, 1989; 62 FR 40600, July 29, 1997; 63 FR 10770, Mar. 5, 1998; 64 FR 40757, July 28, adequate environmental assessment 1999; 64 FR 63204, Nov. 19, 1999; 81 FR 60221, under § 25.40 of this chapter or fails to Aug. 31, 2016] provide sufficient information to establish that the requested action is sub- § 514.115 Withdrawal of approval of ject to categorical exclusion under applications. § 25.30 or § 25.33 of this chapter. (a) The Secretary may suspend ap- (10) The drug fails to satisfy the re- proval of an application approved pur- quirements of subpart E of part 500 of suant to section 512(c) of the act and this chapter. give the applicant prompt notice of his (11) Any nonclinical laboratory study action and afford the applicant the opportunity for an expedited hearing on a that is described in the application and finding that there is an imminent haz- that is essential to show that the drug ard to the health of man or of the ani- is safe for use under the conditions pre- mals for which such new animal drug scribed, recommended, or suggested in or animal feed is intended. its proposed labeling, was not con- (b) The Commissioner shall notify in ducted in compliance with the good writing the person holding an applica- laboratory practice regulations as set tion approved pursuant to section forth in part 58 of this chapter and no 512(c) of the act and afford an oppor- reason for the noncompliance is pro- tunity for a hearing on a proposal to vided or, if it is, the differences be- withdraw approval of such application tween the practices used in conducting if he finds: the study and the good laboratory (1) That the application contains any practice regulations do not support the untrue statement of a material fact; or validity of the study. (2) That the applicant has made any (12) The drug will be produced in changes from the standpoint of safety whole or in part in an establishment or effectiveness beyond the variations provided for in the application unless that is not registered and not exempt he has supplemented the application by from registration under section 510 of filing with the Secretary adequate in- the Federal Food, Drug, and Cosmetic formation respecting all such changes Act and part 207 of this chapter. and unless there is in effect an ap- (b) The Commissioner, as provided in proval of the supplemental application, § 514.200 of this chapter, shall expedi- or such changes are those for which tiously notify the applicant of an op- written authorization or approval is portunity for a hearing on the question not required as provided for in § 514.8. of whether such application is approv- The supplemental application shall be able, unless by the 30th day following treated in the same manner as the the date of issuance of the letter in- original application. forming the applicant of the intention (3) That in the case of an application to issue a notice of opportunity for a for use of a new animal drug approved hearing the applicant: or deemed approved pursuant to sec- (1) Withdraws the application; or tion 512(c) of the act: (i) Experience or scientific data show (2) Waives the opportunity for a hear- that such drug is unsafe for use under ing; or the conditions of use upon the basis of which the application was approved; or (ii) New evidence not contained in such application or not available to the Secretary until after such application was approved, or tests by new methods,

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or tests by methods not deemed reason- used for, the manufacture, processing, ably applicable when such application and packing of such drug or animal was approved, evaluated together with feed are inadequate to assure and pre- the evidence available to the Secretary serve its identity, strength, quality, when the application was approved, and purity and were not made adequate shows that such drug is not shown to within a reasonable time after receipt be safe for use under the conditions of of written notice from the Secretary use upon the basis of which the appli- specifying the matter complained of; or cation was approved or that section 512 (3) That on the basis of new informa- (d)(1)(H) of the act applies to such drug; tion before him, evaluated together or with the evidence before him when the (iii) On the basis of new information application was approved, the labeling before him with respect to such drug, of such drug, based on a fair evaluation evaluated together with the evidence of all material facts, is false or mis- available to him when the application leading in any particular and was not was approved, there is a lack of sub- corrected within a reasonable time stantial evidence that such drug will after receipt of written notice from the have the effect it purports or is rep- Secretary specifying the matter com- resented to have under the conditions plained of. of use prescribed, recommended, or (d) Approval of an application pursu- suggested in the labeling thereof. ant to section 512(c) of the act will be (4) That any nonclinical laboratory withdrawn on the basis of a request for study that is described in the applica- its withdrawal submitted in writing by tion and that is essential to show that a person holding an approved new ani- the drug is safe for use under the condi- mal drug application on the grounds tions prescribed, recommended, or sug- that the drug subject to such applica- gested in its proposed labeling, was not tion is no longer being marketed and conducted in compliance with the good information is included in support of laboratory practice regulations as set this finding, provided none of the con- forth in part 58 of this chapter and no ditions cited in paragraphs (a), (b), and reason for the noncompliance is pro- (c) of this section pertain to the sub- vided or, if it is, the differences be- ject drug. A written request for such tween the practices used in conducting withdrawal shall be construed as a the study and the good laboratory waiver of the opportunity for a hearing practice regulations do not support the as otherwise provided for in this sec- validity of the study. tion. Withdrawal of approval of an ap- (c) The Commissioner may notify in plication under the provisions of this writing the person holding an applica- paragraph shall be without prejudice. tion approved pursuant to section (e) On the basis of the withdrawal of 512(c) of the act and afford an oppor- approval of an application for a new tunity for a hearing on a proposal to animal drug approved pursuant to sec- withdraw approval of such application tion 512(c) of the act, the regulation if he finds: published pursuant to section 512(i) of (1) That the applicant has failed to the act covering the conditions of use establish a system for maintaining re- of such drug as provided for in the ap- quired records, or has repeatedly or de- plication shall be revoked. liberately failed to maintain such records or to make required reports in [40 FR 13825, Mar. 27, 1975, as amended at 50 accordance with a regulation or order FR 7517, Feb. 22, 1985; 64 FR 63204, Nov. 19, under section 512(l)(1) of the act, or the 1999] applicant has refused to permit access to, or copying, or verification of, such § 514.116 Notice of withdrawal of ap- records as required by section 512(l)(2) proval of application. of the act; or When an approval of an application (2) That on the basis of new informa- submitted pursuant to section 512 of tion before him evaluated together the act is withdrawn by the Commis- with the evidence before him when the sioner, he will give appropriate public application was approved, the methods notice of such action by publication in used in, or the facilities and controls the FEDERAL REGISTER.

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§ 514.117 Adequate and well-controlled (3) The study is conducted with a new studies. animal drug that is produced in accord- (a) Purpose. The primary purpose of ance with appropriate manufacturing conducting adequate and well-con- practices, which include, but are not trolled studies of a new animal drug is necessarily limited to, the manufac- to distinguish the effect of the new ani- ture, processing, packaging, holding, mal drug from other influences, such as and labeling of the new animal drug spontaneous change in the course of such that the critical characteristics of the disease, normal animal production identity, strength, quality, purity, and performance, or biased observation. physical form of the new animal drug One or more adequate and well-con- are known, recorded, and reproducible, trolled studies are required to estab- to permit meaningful evaluations of lish, by substantial evidence, that a and comparisons with other studies new animal drug is effective. The char- conducted with the new animal drug. acteristics described in paragraph (b) The physical form of a new animal of this section have been developed drug includes the formulation and over a period of years and are generally physical characterization (including recognized as the essentials of an ade- delivery systems thereof, if any) of the quate and well-controlled study. Well new animal drug as presented to the controlled, as used in the phrase ade- animal. The protocol and study report quate and well controlled, emphasizes must include an identification number an important aspect of adequacy. The which can be correlated with the spe- Food and Drug Administration (FDA) cific formulation and production proc- considers these characteristics in de- ess used to manufacture the new ani- termining whether a study is adequate mal drug used in the study. and well controlled for purposes of sec- (4) The study uses a design that per- tion 512 of the Federal Food, Drug, and mits a valid comparison with one or Cosmetic Act (the act) (21 U.S.C. 360b). more controls to provide a quantitative Adequate and well-controlled studies, evaluation of drug effects. The protocol in addition to providing a basis for de- and the study report must describe the termining whether a new animal drug precise nature of the study design, e.g., is effective, may also be relied upon to duration of treatment periods, whether support target animal safety. The re- treatments are parallel, sequential, or port of an adequate and well-controlled crossover, and the determination of study should provide sufficient details sample size. Within the broad range of of study design, conduct, and analysis studies conducted to support a deter- to allow critical evaluation and a de- mination of the effectiveness of a new termination of whether the character- animal drug, certain of the controls istics of an adequate and well-con- listed below would be appropriate and trolled study are present. preferred depending on the study con- (b) Characteristics. An adequate and ducted: well-controlled study has the following (i) Placebo concurrent control. The new characteristics: animal drug is compared with an inac- (1) The protocol for the study (pro- tive preparation designed to resemble tocol) and the report of the study re- the new animal drug as far as possible. sults (study report) must include a (ii) Untreated concurrent control. The clear statement of the study objec- new animal drug is compared with the tive(s). absence of any treatment. The use of (2) The study is conducted in accord- this control may be appropriate when ance with an appropriate standard of objective measurements of effective- conduct that addresses, among other ness, not subject to observer bias, are issues, study conduct, study personnel, available. study facilities, and study documenta- (iii) Active treatment concurrent con- tion. The protocol contains a state- trol. The new animal drug is compared ment acknowledging the applicability with known effective therapy. The use of, and intention to follow, a standard of this control is appropriate when the of conduct acceptable to FDA. The use of a placebo control or of an un- study report contains a statement de- treated concurrent control would un- scribing adherence to the standard. reasonably compromise the welfare of

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the animals. Similarity of the new ani- pertinent variables such as age, sex, mal drug and the active control drug class of animal, severity of disease, du- can mean either that both drugs were ration of disease, dietary regimen, effective or that neither was effective. level of animal production, and use of The study report should assess the drugs or therapy other than the new ability of the study to have detected a animal drug. The protocol and the difference between treatments. The study report describe the method of as- evaluation of the study should explain signment of animals to an experi- why the new animal drugs should be mental unit to account for pertinent considered effective in the study, for variables and method of assignment of example, by reference to results in pre- a treatment or a control to the experi- vious placebo-controlled studies of the mental units. When the effect of such active control. variables is accounted for by an appro- (iv) Historical control. The results of priate design, and when, within the treatment with the new animal drug same animal, effects due to the test are quantitatively compared with expe- drug can be obtained free of the effects rience historically derived from the of such variables, the same animal may adequately documented natural history be used for both the test drug and the of the disease or condition, or with a control using the controls set forth in regimen (therapeutic, diagnostic, pro- paragraph (b)(4) of this section. phylactic) whose effectiveness is estab- (7) The study uses methods to mini- lished, in comparable animals. Because mize bias on the part of observers and historical control populations usually analysts of the data that are adequate cannot be as well assessed with respect to prevent undue influences on the re- to pertinent variables as can concur- sults and interpretation of the study rent control populations, historical data. The protocol and study report ex- control designs are usually reserved for plain the methods of observation and special circumstances. Examples in- recording of the animal response vari- clude studies in which the effect of the ables and document the methods, such new animal drug is self-evident or stud- as ‘‘blinding’’ or ‘‘masking,’’ used in ies of diseases with high and predict- the study for excluding or minimizing able mortality, or signs and symptoms bias in the observations. of predictable duration or severity, or, (8) The study uses methods to assess in the case of prophylaxis, predictable animal response that are well defined morbidity. and reliable. The protocol and study re- (5) The study uses a method of select- port describe the methods for con- ing animals that provides adequate as- ducting the study, including any appro- surances that the animals are suitable priate analytical and statistical meth- for the purposes of the study. For ex- ods, used to collect and analyze the ample, the animals can reasonably be data resulting from the conduct of the expected to have animal production study, describe the criteria used to as- characteristics typical of the class(es) sess response, and, when appropriate, of animals for which the new animal justify the selection of the methods to drug is intended, there is adequate as- assess animal response. surance that the animals have the dis- (9) There is an analysis and evalua- ease or condition being studied, or, in tion of the results of the study in ac- the case of prophylactic agents, evi- cord with the protocol adequate to as- dence of susceptibility and exposure to sess the effects of the new animal drug. the condition against which prophy- The study report evaluates the meth- laxis is desired has been provided. The ods used to conduct, and presents and protocol and the study report describe evaluates the results of, the study as to the method of selecting animals for the their adequacy to assess the effects of study. the new animal drug. This evaluation (6) The study uses a method to assign of the results of the study assesses, a treatment or a control to each exper- among other items, the comparability imental unit of animals that is random of treatment and control groups with and minimizes bias. Experimental respect to pertinent variables and the units of animals are groups of animals effects of any interim analyses per- that are comparable with respect to formed.

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(c) Field studies. (1) Field conditions may provide corroborative support of as used in this section refers to condi- adequate and well-controlled studies tions which closely approximate the regarding effectiveness and may yield conditions under which the new animal valuable data regarding safety of the drug, if approved, is intended to be ap- new animal drug. Such studies will be plied or administered. considered on their merits in light of (2) Studies of a new animal drug con- the characteristics listed here. Isolated ducted under field conditions shall, case reports, random experience, and consistent with generally recognized reports lacking the details which per- scientific principles and procedures, mit scientific evaluation will not be use an appropriate control that per- considered. mits comparison, employ procedures to [63 FR 10770, Mar. 5, 1998] minimize bias, and have the characteristics generally described in paragraph § 514.120 Revocation of order refusing (b) of this section. However, because to approve an application or sus- field studies are conducted under field pending or withdrawing approval conditions, it is recognized that the of an application. level of control over some study condi- The Commissioner, upon his own ini- tions need not or should not be the tiative or upon request of an applicant same as the level of control in labora- stating reasonable grounds therefor tory studies. While not all conditions and if he finds that the facts so require, relating to a field study need to be or may issue an order approving an appli- should be controlled, observations of cation that previously has had its ap- the conditions under which the new proval refused, suspended, or with- animal drug is tested shall be recorded drawn. in sufficient detail to permit evaluation of the study. Adequate and well- § 514.121 Service of notices and orders. controlled field studies shall balance the need to control study conditions All notices and orders under this sub- with the need to observe the true effect chapter E and section 512 of the act of the new animal drug under closely pertaining to new animal drug applica- approximated actual use conditions. tions shall be served: (d) Waiver. The Director of the Center (a) In person by any officer or em- for Veterinary Medicine (the Director) ployee of the Department designated may, on the Director’s own initiative by the Commissioner; or or on the petition of an interested per- (b) By mailing the order by certified son, waive in whole or in part any of mail addressed to the applicant or re- the criteria in paragraph (b) of this sec- spondent at his last known address in tion with respect to a specific study. A the records of the Food and Drug Ad- petition for a waiver is required to set ministration. forth clearly and concisely the specific criteria from which waiver is sought, Subpart C—Hearing Procedures why the criteria are not reasonably applicable to the particular study, what § 514.200 Notice of opportunity for alternative procedures, if any, are to hearing; notice of participation and be, or have been employed, and what requests for hearing; grant or de- results have been obtained. The peti- nial of hearing. tion is also required to state why the (a) The notice to the applicant of op- studies so conducted will yield, or have portunity for a hearing on a proposal yielded, substantial evidence of effec- by the Commissioner to refuse to ap- tiveness, notwithstanding nonconform- prove an application or to withdraw ance with the criteria for which waiver the approval of an application will be is requested. published in the FEDERAL REGISTER to- (e) Uncontrolled studies. Uncontrolled gether with an explanation of the studies or partially controlled studies grounds for the proposed action. The are not acceptable as the sole basis for notice will describe how to request a the approval of claims of effectiveness hearing. An applicant has 30 days after or target animal safety. Such studies, publication of the notice to request a carefully conducted and documented, hearing.

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(b) If the applicant fails to request a (iv) The specific issues of fact for res- hearing within the 30-day timeframe, olution at the hearing; the Commissioner, without further no- (v) The presiding officer, or a state- tice, will publish a final order denying ment that the presiding officer will be or withdrawing approval of the applica- designated in a later notice; and tion. (vi) The date, time, and place of the (c) If the applicant desires to request prehearing conference, or a statement a hearing: that the date, time, and place will be (1) Within 30 days after publication of announced in a later notice. However, the notice of opportunity for hearing, in the case of a denial of approval, the the applicant must submit to the Divi- hearing must not occur more than 90 sion of Dockets Management written days after expiration of the 30-day time objections and a request for a hearing period in which to request a hearing, unless the presiding officer and the ap- in accordance with §§ 12.20 and 12.22. plicant otherwise agree; and in the case This request for a hearing must include of withdrawal of approval, the hearing each specific objection to the proposal will occur as soon as practicable. on which a hearing is requested, to- (d) The hearing will be open to the gether with a detailed description and public; however, if the Commissioner analysis of the factual information (in- finds that portions of the application cluding all relevant clinical and other which serve as a basis for the hearing investigational data) the applicant will contain information concerning a present in support of that objection. A method or process entitled to protec- request for a hearing may not rest tion as a trade secret, the part of the upon mere allegations or denials or hearing involving such portions will general descriptions of positions or not be public, unless the respondent so contentions, but must set forth specific specifies in the request for a hearing. reliable evidence showing there is a genuine and substantial issue of fact [81 FR 52997, Aug. 11, 2016] that requires a hearing. § 514.201 Procedures for hearings. (2) If the Commissioner determines upon review of the data and informa- Hearings relating to new animal tion submitted in the objections and drugs under section 512(d) and (e) of the act shall be governed by part 12 of this request for a hearing that a hearing is chapter. not justified because no genuine and substantial issue of fact precludes the [64 FR 63204, Nov. 19, 1999] refusal to approve the application or the withdrawal of approval of the ap- Subparts D–E [Reserved] plication (for example, the applicant has not identified any adequate and Subpart F—Judicial Review well-controlled clinical investigations to support the claims of effectiveness), § 514.235 Judicial review. the Commissioner will enter an order (a) The transcript and record shall be denying the hearing and stating the certified by the Commissioner. In any final findings and conclusions. case in which the Commissioner enters (3) If the Commissioner determines an order without a hearing pursuant to upon review of the data and informa- § 314.200(g) of this chapter, the re- tion submitted in the objections and quest(s) for hearing together with the request for a hearing that a hearing is data and information submitted and justified, the Commissioner will pub- the Commissioner’s findings and con- lish a notice setting forth the fol- clusions shall be included in the record lowing: certified by the Commissioner. (i) The regulation or order that is the (b) Judicial review of an order with- subject of the hearing; drawing approval of a new drug appli- (ii) A statement specifying any part cation, whether or not a hearing has of the regulation or order that has been been held, may be sought by a manu- stayed by operation of law or in the facturer or distributor of an identical, Commissioner’s discretion; related, or similar drug product, as de- (iii) The parties to the hearing; fined in § 310.6 of this chapter, in a

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United States court of appeals pursu- (b) A completed medicated feed mill ant to section 505(h) of the act. license must contain the following information: [42 FR 4717, Jan. 25, 1977] (1) The full business name and address of the facility at which the manu- PART 515—MEDICATED FEED MILL facturing is to take place. LICENSE (2) The facility’s FDA registration number as required by section 510 of Subpart A—Applications the Federal Food, Drug, and Cosmetic Act (the act). Sec. (3) The name, title, and signature of 515.10 Medicated feed mill license applica- the responsible individual or individ- tions. uals for that facility. 515.11 Supplemental medicated feed mill li- (4) A certification that the animal cense applications. feeds bearing or containing new animal Subpart B—Administrative Actions on drugs are manufactured and labeled in Licenses accordance with the applicable regulations published under section 512(i) of 515.20 Approval of medicated feed mill li- the act or in accordance with the index cense applications. listing published under section 572(e)(2) 515.21 Refusal to approve a medicated feed of the act. mill license application. (5) A certification that the methods 515.22 Suspension and/or revocation of ap- used in, and the facilities and controls proval of a medicated feed mill license. used for, manufacturing, processing, 515.23 Voluntary revocation of medicated packaging, and holding such animal feed mill license. 515.24 Notice of revocation of a medicated feeds conform to current good manu- feed mill license. facturing practice as described in sec- 515.25 Revocation of order refusing to ap- tion 501(a)(2)(B) of the act and in part prove a medicated feed mill license appli- 225 of this chapter. cation or suspending or revoking a li- (6) A certification that the facility cense. will establish and maintain all records 515.26 Services of notices and orders. required by regulation or order issued under sections 512(m)(5)(A) or Subpart C—Hearing Procedures 504(a)(3)(A) of the act, and will permit access to, or copying or verification of 515.30 Contents of notice of opportunity for a hearing. such records. 515.31 Procedures for hearings. (7) A commitment that current approved or index listed Type B and/or Subpart D—Judicial Review Type C medicated feed labeling for each Type B and/or Type C medicated 515.40 Judicial review. feed to be manufactured will be in the AUTHORITY: 21 U.S.C. 360b, 371. possession of the feed manufacturing facility prior to receiving the Type A SOURCE: 64 FR 63204, Nov. 19, 1999, unless medicated article containing such otherwise noted. drug. (8) A commitment to renew registra- Subpart A—Applications tion every year with FDA as required in part 207 of this chapter. § 515.10 Medicated feed mill license (c) Applications must be completed, applications. signed, and submitted to the Division (a) Medicated feed mill license appli- of Animal Feeds (HFV–220), Center for cations (Forms FDA 3448) may be ob- Veterinary Medicine, Food and Drug tained from the Public Health Service, Administration, 7500 Standish Pl., Consolidated Forms and Publications Rockville, MD 20855. Distribution Center, Washington Com- (d) Applications that are facially de- merce Center, 3222 Hubbard Rd., Land- ficient will be returned to the appli- over, MD 20785, or electronically from cant. All reasons for the return of the the Center for Veterinary Medicine application will be made known to the home page at http://www.fda.gov/cvm. applicant.

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(e) Upon approval, the original copy § 515.21 Refusal to approve a medi- of the application will be signed by an cated feed mill license application. authorized employee of FDA des- (a) The Commissioner of Food and ignated by the Commissioner of Food Drugs (the Commissioner) shall within and Drugs, and a copy will be returned to the applicant. 90 days, or such additional period as may be agreed upon by the Commis- [64 FR 63204, Nov. 19, 1999, as amended at 72 sioner and the applicant, after the fil- FR 69121, Dec. 6, 2007; 81 FR 60221, Aug. 31, ing of an application under § 515.10, in- 2016] form the applicant in writing of his/her § 515.11 Supplemental medicated feed intention to issue a notice of oppor- mill license applications. tunity for a hearing on a proposal to (a) After approval of a medicated feed refuse to approve the application, if the mill license application to manufac- Commissioner determines upon the ture animal feed, a supplemental appli- basis of the application, on the basis of cation shall be submitted for a change a preapproval inspection, or upon the in ownership and/or a change in mail- basis of any other information before ing address of the facility site. him that: (b) Each supplemental application (1) The application is incomplete, should be accompanied by a fully com- false, or misleading in any particular; pleted Form FDA 3448 and include an or explanation of the change. (2) The methods used in and the fa- (c) Within 30 working days after a cilities and controls used for the manu- supplemental application has been facturing, processing, and packaging of filed, if the Commissioner of Food and Drugs determines that the application such animal feed are not adequate to provides adequate information respect- preserve the identity, strength, qual- ing the change in ownership and/or ity, and purity of the new animal drug postal address of the facility site, then therein; or an authorized employee of the Food (3) The facility manufactures animal and Drug Administration designated by feeds bearing or containing new animal the Commissioner shall notify the ap- drugs in a manner that does not accord plicant that it is approved by signing with the specifications for manufac- and mailing to the applicant a copy of ture or labels animal feeds bearing or the Form FDA 3448. Supplemental ap- containing new animal drugs in a man- plications that do not provide adequate ner that does not accord with the con- information shall be returned to the ditions or indications of use that are applicant and all reasons for the return published under section 512(i) or of the application shall be made known 572(e)(2) of the act. to the applicant. (b) The Commissioner, as provided in § 515.30, shall expeditiously notify the Subpart B—Administrative Actions applicant of an opportunity for a hear- on Licenses ing on the question of whether such application is approvable, unless by the § 515.20 Approval of medicated feed mill license applications. 30th day following the date of issuance of the letter informing the applicant of Within 90 days after an application the intention to issue a notice of op- has been filed under § 515.10, if the Com- portunity for a hearing the applicant: missioner of Food and Drugs (the Com- missioner) determines that none of the (1) Withdraws the application; or grounds for denying approval specified (2) Waives the opportunity for a hear- in section 512(m)(3) of the Federal ing; or Food, Drug, and Cosmetic Act (the act) (3) Agrees with the Commissioner on applies, an authorized employee of the an additional period to precede Food and Drug Administration des- issuance of such notice of hearing. ignated by the Commissioner shall no- [64 FR 63204, Nov. 19, 1999, as amended at 72 tify the applicant that it is approved FR 69121, Dec. 6, 2007] by signing and mailing to the applicant a copy of the Form FDA 3448.

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§ 515.22 Suspension and/or revocation used for, the manufacture, processing, of approval of a medicated feed mill packing, and holding of such animal license. feed are inadequate to assure and pre- (a) The Secretary of Health and serve the identity, strength, quality, Human Services may suspend a medi- and purity of the new animal drug cated feed mill license approved under therein, and were not made adequate section 512(m)(2) of the Federal Food, within a reasonable time after receipt Drug, and Cosmetic Act (the act) and of written notice from the Commis- give the person holding the medicated sioner specifying the matter com- feed mill license application prompt plained of; or notice of this action and afford the ap- (3) That on the basis of new informa- plicant the opportunity for an expe- tion before him, evaluated together dited hearing on a finding that there is with the evidence before him when an imminent hazard to the health of such license was issued, the labeling of man or of the animals for which such any animal feeds, based on a fair eval- animal feed is intended. (b) The Commissioner of Food and uation of all material facts, is false or Drugs (the Commissioner) shall notify misleading in any particular and was in writing the person holding an appli- not corrected within a reasonable time cation approved under section 512(m)(2) after receipt of written notice from the of the act and afford an opportunity for Commissioner specifying the matter a hearing on a proposal to revoke ap- complained of; or proval of such application if the Com- (4) That on the basis of new informa- missioner finds: tion before him, evaluated together (1) That the application contains any with the evidence before him when untrue statement of a material fact; or such license was issued, the facility has (2) That the applicant has made any manufactured, processed, packed, or changes that would cause the applica- held animal feed bearing or containing tion to contain any untrue statements a new animal drug adulterated under of material fact or that would affect section 501(a)(6) of the act, and the fa- the safety or effectiveness of the ani- cility did not discontinue the manufac- mal feeds manufactured at the facility ture, processing, packing, or holding of unless the applicant has supplemented such animal feed within a reasonable the application by filing a supple- time after receipt of written notice mental application under § 515.11. from the Commissioner specifying the (c) The Commissioner may notify in matter complained of. writing the person holding an application approved under section 512(m)(2) of § 515.23 Voluntary revocation of medi- the act and afford an opportunity for a cated feed mill license. hearing on a proposal to revoke approval of such application if the Com- A license issued under section missioner finds: 512(m)(2) of the Federal Food, Drug, (1) That the applicant has failed to and Cosmetic Act (the act) will be re- establish a system for maintaining revoked on the basis of a request for its quired records, or has repeatedly or de- revocation submitted in writing by a liberately failed to maintain such responsible individual holding such li- records or to make required reports in cense on the grounds that the facility accordance with a regulation or order no longer manufactures any animal under sections 512(m)(5)(A) or feed covered under § 558.4(b) of this 504(a)(3)(A) of the act, or the applicant chapter. A written request for such has refused to permit access to, or revocation shall be construed as a copying, or verification of, such waiver of the opportunity for a hearing records as required by sections as otherwise provided for in this sec- 512(m)(5)(B) or 504(a)(3)(B) of the act; or tion. Revocation of approval of a medi- (2) That on the basis of new informa- cated feed mill license under the provi- tion before him, evaluated together sions of this paragraph shall be with- with the evidence before him when out prejudice. such license was issued, the methods used in, or the facilities and controls

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§ 515.24 Notice of revocation of a medi- in the FEDERAL REGISTER and will cated feed mill license. specify that the applicant has 30 days When a license approved under sec- after issuance of the notice within tion 512 of the Federal Food, Drug, and which the Commissioner is required to Cosmetic Act (the act) is revoked by file a written appearance electing the Commissioner of Food and Drugs whether: (the Commissioner), the Commissioner (1) To avail himself of the oppor- will give appropriate public notice of tunity for a hearing; or such action by publication in the FED- (2) Not to avail himself of the oppor- ERAL REGISTER. tunity for a hearing. (b) If the applicant fails to file a § 515.25 Revocation of order refusing written appearance in answer to the to approve a medicated feed mill li- notice of opportunity for hearing, this cense application or suspending or failure will be construed as an election revoking a license. not to avail himself of the opportunity The Commissioner of Food and Drugs for the hearing, and the Commissioner (the Commissioner), upon his/her own without further notice may enter a initiative or upon request of an appli- final order. cant stating reasonable grounds there- (c) If the applicant elects to avail for and if the Commissioner finds that himself of the opportunity for a hear- the facts so require, may issue an order ing, the applicant is required to file a approving a medicated feed mill license written appearance requesting the application that previously has had its hearing within 30 days after the publi- approval refused, suspended, or re- cation of the notice, giving the reason voked. why the application should not be refused or the medicated feed mill license § 515.26 Services of notices and orders. should not be revoked, together with a All notices and orders under this part well-organized and full-factual analysis 515 and section 512 of the Federal Food, of the information the applicant is pre- Drug, and Cosmetic Act (the act) per- pared to prove in support of his opposi- taining to medicated feed mill licenses tion to the Commissioner’s proposal. A shall be served: request for a hearing may not rest (a) In person by any officer or em- upon mere allegations or denials, but ployee of the Department of Health and must set forth specific facts showing Human Services designated by the there is a genuine and substantial issue Commissioner of Food and Drugs; or of fact that requires a hearing. When it (b) By mailing the order by certified clearly appears from the information mail addressed to the applicant or rein the application and from the reasons spondent at the applicant or respond- and factual analysis in the request for ent’s last known address in the records the hearing that no genuine and sub- of the Food and Drug Administration. stantial issue of fact precludes the refusal to approve the application or the Subpart C—Hearing Procedures revocation of approval of the application, the Commissioner will enter an § 515.30 Contents of notice of oppor- order on this information, stating his/ tunity for a hearing. her findings and conclusions. If a hear- (a) The notice to the applicant of op- ing is requested and is justified by the portunity for a hearing on a proposal applicant’s response to the notice of by the Commissioner of Food and opportunity for a hearing, the issues Drugs (the Commissioner) to refuse to will be defined, an Administrative Law approve a medicated feed mill license Judge will be named, and the Judge application or to revoke the approval shall issue a written notice of the time of a medicated feed mill license will and place at which the hearing will specify the grounds upon which the commence. In the case of denial of ap- Commissioner proposes to issue this proval, such time shall be not more order. On request of the applicant, the than 90 days after the expiration of Commissioner will explain the reasons such 30 days unless the Administrative for the action. The notice of oppor- Law Judge and the applicant otherwise tunity for a hearing will be published agree; and, in the case of withdrawal of

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approval, such time shall be as soon as 516.23 Timing of requests for MUMS-drug practicable. designation. (d) The hearing will be open to the 516.24 Granting MUMS-drug designation. 516.25 Refusal to grant MUMS-drug designa- public; however, if the Commissioner tion. finds that portions of the application 516.26 Amendment to MUMS-drug designa- which serve as a basis for the hearing tion. contain information concerning a 516.27 Change in sponsorship. method or process entitled to protec- 516.28 Publication of MUMS-drug designation as a trade secret, the part of the tions. hearing involving such portions will 516.29 Termination of MUMS-drug designation. not be public, unless the respondent so 516.30 Annual reports for a MUMS-des- specifies in the appearance. ignated drug. 516.31 Scope of MUMS-drug exclusive mar- § 515.31 Procedures for hearings. keting rights. Hearings relating to new animal 516.34 FDA recognition of exclusive mar- drugs under section 512(m)(3) and (m)(4) keting rights. 516.36 Insufficient quantities of MUMS-des- of the Federal Food, Drug, and Cos- ignated drugs. metic Act (the act) shall be governed 516.52 Availability for public disclosure of by part 12 of this chapter. data and information in requests.

Subpart D—Judicial Review Subpart C—Index of Legally Marketed Un- approved New Animal Drugs for Minor § 515.40 Judicial review. Species The transcript and record shall be 516.111 Scope of this subpart. certified by the Commissioner of Food 516.115 Definitions. and Drugs (the Commissioner). In any 516.117 Submission of correspondence under case in which the Commissioner enters this subpart. 516.119 Permanent-resident U.S. agent for an order without a hearing under foreign requestors and holders. § 314.200(g) of this chapter, the re- 516.121 Meetings. quest(s) for hearing together with the 516.123 Informal conferences regarding data and information submitted and agency administrative actions. the Commissioner’s findings and con- 516.125 Investigational use of minor species clusions shall be included in the record new animal drugs to support indexing. certified by the Commissioner. 516.129 Content and format of a request for determination of eligibility for indexing. 516.131 Refuse to file a request for deter- PART 516—NEW ANIMAL DRUGS mination of eligibility for indexing. FOR MINOR USE AND MINOR 516.133 Denying a request for determination SPECIES of eligibility for indexing. 516.135 Granting a request for determination of eligibility for indexing. Subpart A—General Provisions 516.137 Notification of decision regarding eligibility for indexing. Sec. 516.141 Qualified expert panels. 516.1 Scope. 516.143 Written report. 516.2 Purpose. 516.145 Content and format of a request for 516.3 Definitions. addition to the index. 516.147 Refuse to file a request for addition Subpart B—Designation of a Minor Use or to the index. Minor Species New Animal Drug 516.149 Denying a request for addition to the index. 516.11 Scope of this subpart. 516.151 Granting a request for addition to 516.12 Purpose. the index. 516.13 Definitions. 516.153 Notification of decision regarding 516.14 Submission of requests for designa- index listing. tion. 516.155 Labeling of indexed drugs. 516.16 Eligibility to request designation. 516.157 Publication of the index and content 516.20 Content and format of a request for of an index listing. MUMS-drug designation. 516.161 Modifications to indexed drugs. 516.21 Documentation of minor use status. 516.163 Change in ownership of an index file. 516.22 Permanent-resident U.S. agent for 516.165 Records and reports. foreign sponsor. 516.167 Removal from the index.

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516.171 Confidentiality of data and informa- Functionally superior means that a tion in an index file. drug has been shown to provide a significant therapeutic or physiologic ad- Subpart D [Reserved] vantage over that provided by a condi- Subpart E—Conditionally Approved New tionally-approved or approved MUMS Animal Drugs For Minor Use and Minor drug, that is otherwise the same drug, Species in one or more of the following ways: (i) The drug has been shown to be 516.1684 Paclitaxel. more effective, as assessed by effect on 516.2065 Rabacfosadine. a clinically meaningful endpoint in AUTHORITY: 21 U.S.C. 360ccc–1, 360ccc–2, 371. adequate and well-controlled clinical SOURCE: 72 FR 41017, July 26, 2007, unless trials, than a conditionally approved or otherwise noted. approved MUMS drug, that is otherwise the same drug. Generally, this Subpart A—General Provisions would represent the same kind of evidence needed to support a comparative § 516.1 Scope. effectiveness claim for two different (a) This part implements section 573 drugs; in most cases, direct compara- of the Federal Food, Drug, and Cos- tive clinical trials will be necessary; or metic Act (the act) (21 U.S.C. 360ccc–2) (ii) The drug has been shown to be and contains the following subparts: safer than a conditionally-approved or (1) Subpart A—General Provisions. approved MUMS drug, that is other- (2) Subpart B—Designation of a wise the same drug, in a substantial Minor Use or Minor Species New Ani- portion of the target population, for mal Drug. example, by the elimination of an in- (3) Subpart C [Reserved] gredient or contaminant that is associ- (4) Subpart D [Reserved] ated with relatively frequent adverse (b) References in this part to regu- effects. In some cases, direct compara- latory sections of the Code of Federal tive clinical trials will be necessary. Regulations are to Chapter I of Title Infrequently, as used in the minor use 21, unless otherwise noted. definition, means a disease or condition that is uncommon or that occurs § 516.2 Purpose. only sporadically on an annualized This part establishes standards and basis. procedures for implementing section Limited geographical areas, as used in 573 of the act, including designation of the minor use definition, means re- minor use or minor species new animal gions of the United States distin- drugs and associated exclusive mar- guished by physical, chemical, or bio- keting rights. logical factors that limit the distribution of a disease or condition. § 516.3 Definitions. Major species means cattle, horses, (a) The definitions and interpreta- swine, chickens, turkeys, dogs, and tions contained in section 201 of the cats. Federal Food, Drug, and Cosmetic Act Minor species means animals, other (the act) (21 U.S.C. 321) apply to those than humans, that are not major spe- terms when used in this part. cies. (b) The following definitions of terms Minor use means the intended use of apply to all subparts of part 516: a drug in a major species for an indica- Active moiety means the molecule or tion that occurs infrequently and in ion, excluding those appended portions only a small number of animals or in of the molecule that cause the drug to limited geographical areas and in only be an ester, salt (including a salt with hydrogen or coordination bonds), or a small number of animals annually. other noncovalent derivative (such as a MUMS drug means a new animal complex, chelate, or clathrate) of the drug, as defined in section 201 of the molecule, responsible for the pharma- act, intended for a minor use or for use cological action of the drug substance. in a minor species.

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Same dosage form means the same as in structure between them were due to one of the dosage form categories spec- post-translational events or infidelity ified in the following parts of this of translation or transcription or were chapter: minor differences in amino acid se- (i) Part 520: Oral dosage form new quence; other potentially important animal drugs (excluding use in animal differences, such as different glycosyl- feeds as specified in part 558 of this ation patterns or different tertiary chapter). structures, would not cause the drugs (ii) Part 522: Implantation or to be considered different unless the injectable dosage form new animal subsequent drug is shown to be func- drugs. tionally superior. (iii) Part 524: Ophthalmic and topical (B) Two polysaccharide drugs would dosage form new animal drugs. be considered the same if they had (iv) Part 526: Intramammary dosage identical saccharide repeating units, forms. even if the number of units were to (v) Part 529: Certain other dosage vary and even if there were postpolym- form new animal drugs. erization modifications, unless the sub- (vi) Part 558: New animal drugs for sequent drug is shown to be function- use in animal feeds. ally superior. Same drug means a MUMS drug for (C) Two polynucleotide drugs con- which designation, indexing, or condi- sisting of two or more distinct nucleo- tional approval is sought that meets tides would be considered the same if the following criteria: they had an identical sequence of pu- (i) If it is a MUMS drug composed of rine and pyrimidine bases (or their de- small molecules and contains the same rivatives) bound to an identical sugar active moiety as a prior designated, backbone (ribose, deoxyribose, or modi- conditionally-approved, or approved fications of these sugars), unless the MUMS drug, even if the particular subsequent drug is shown to be func- ester or salt (including a salt with hy- tionally superior. drogen or coordination bonds) or other (D) Closely related, complex partly noncovalent derivative such as a com- definable drugs with similar pharmaco- plex, chelate or clathrate is not the logic intent would be considered the same, it is considered the same drug; same unless the subsequent drug is except that, if the prior MUMS drug is shown to be functionally superior. conditionally approved or approved and Same intended use means an intended the second MUMS drug is shown to be use of a MUMS drug, for which designa- functionally superior to the condition, indexing, or conditional approval tionally approved or approved MUMS is sought, that is determined to be the drug for the same intended use, it is same as (or not different from) a pre- not considered the same drug. viously designated, conditionally ap- (ii) If it is a MUMS drug composed of proved, or approved intended use of a large molecules (macromolecules) and MUMS drug. Same intended use is es- contains the same principal molecular tablished by comparing two intended structural features (but not necessarily uses and not by simply comparing the all of the same structural features) as specific language by means of which a prior designated, conditionally ap- the intent is established in labeling in proved, or approved MUMS drug, it is accordance with the following criteria: considered the same drug; except that, (i) Two intended uses are considered if the prior MUMS drug is condi- the same if one of the intended uses tionally approved or approved and the falls completely within the scope of the second MUMS drug is shown to be func- other. tionally superior to the conditionally (ii) For intended uses associated with approved or approved MUMS drug for diseases or conditions with multiple the same intended use, it is not consid- causative organisms, two intended uses ered the same drug. This criterion will are not considered the same when they be applied as follows to different kinds involve different causative organisms of macromolecules: or different subsets of causative orga- (A) Two protein drugs would be con- nisms of that disease or condition when sidered the same if the only differences the causative organisms involved can

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reliably be shown to be clinically sig- bility for designation and the associ- nificant causes of the disease or condi- ated incentives and benefits described tion. in section 573 of the act, including a 7- (iii) Two intended uses of a drug are year period of exclusive marketing not considered the same if they involve rights. different intended species or different definable subpopulations (including § 516.13 Definitions. ‘‘production classes’’) of a species. The following definitions of terms Small number of animals means equal apply only in the context of subpart B to or less than 50,000 horses; 70,000 dogs; of this part: 120,000 cats; 310,000 cattle; 1,450,000 pigs; Director means the Director of the Of- 14,000,000 turkeys; and 72,000,000 chick- fice of Minor Use and Minor Species ens. Animal Drug Development of the FDA Sponsor means the person requesting Center for Veterinary Medicine. designation for a MUMS drug who Intended use means the intended must be the real party in interest of treatment, control or prevention of a the development and the intended or disease or condition, or the intention actual production and sales of such to affect the structure or function of drug (in this context, the sponsor may the body of animals within an identi- be an individual, partnership, organiza- fied species, subpopulation of a species, tion, or association). Sponsor also or collection of species. means the person responsible for an in- MUMS-designated drug means a new vestigation of a new animal drug (in animal drug, as defined in section 201 this context, the sponsor may be an in- of the act, intended for a minor use or dividual, partnership, corporation, or for use in a minor species that has been Government agency or may be a manu- designated under section 573 of the act. facturer, scientific institution, or an investigator regularly and lawfully en- MUMS-drug exclusive marketing rights gaged in the investigation of new ani- or exclusive marketing rights means that, mal drugs). Sponsor also means the effective on the date of FDA condi- person submitting or receiving ap- tional approval or approval as stated in proval for a new animal drug applica- the approval letter of an application tion (in this context, the sponsor may for a MUMS-designated drug, no condi- be an individual, partnership, organiza- tional approval or approval will be tion, or association). In all contexts, given to a subsequent application for the sponsor is responsible for compli- the same drug, in the same dosage ance with applicable provisions of the form, for the same intended use for 7 act and regulations. years, except as otherwise provided by law or in this subpart. [72 FR 41017, July 26, 2007, as amended at 74 FR 43050, Aug. 25, 2009; 75 FR 69588, Nov. 15, § 516.14 Submission of requests for 2010] designation. All correspondence relating to a re- Subpart B—Designation of a Minor quest for designation of a MUMS drug Use or Minor Species New must be addressed to the Director of Animal Drug the Office of Minor Use and Minor Spe- cies Animal Drug Development. Sub- § 516.11 Scope of this subpart. missions not including all elements This subpart implements section 573 specified in § 516.20 will be returned to of the act. Specifically, this subpart the sponsor without review. sets forth the procedures and requirements for submissions to FDA of re- § 516.16 Eligibility to request designa- quests for designation of a new animal tion. drug for a minor use or a minor spe- The person requesting designation cies. must be the sponsor and the real party in interest of the development and the § 516.12 Purpose. intended or actual production and sales This subpart establishes standards of the drug or the permanent-resident and procedures for determining eligi- U.S. agent for such a sponsor.

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§ 516.20 Content and format of a re- pended authoritative references, to quest for MUMS-drug designation. demonstrate that such use is a minor (a) A sponsor that submits a request use. for designation of a new animal drug (8) A statement that the sponsor sub- intended for a minor use or minor spe- mitting the request is the real party in cies must submit each request in the interest of the development and the inform and containing the information tended or actual production and sales required in paragraph (b) of this sec- of the product. tion. While a request for designation (9) A statement that the sponsor ac- may involve multiple intended uses, knowledges that, upon granting a re- each request for designation must con- quest for MUMS designation, FDA will stitute a separate submission. A spon- make information regarding the des- sor may request MUMS-drug designa- ignation publicly available as specified tion of a previously unapproved drug, in § 516.28. or a new intended use or dosage form for an already conditionally approved [72 FR 41017, July 26, 2007, as amended at 75 or approved drug. Only one sponsor FR 69588, Nov. 15, 2010; 77 FR 18685, Mar. 28, may receive MUMS-drug designation of 2012] the same drug, in the same dosage form, for the same intended use. § 516.21 Documentation of minor use (b) A sponsor must submit two copies status. of a completed, dated, and signed re- So that FDA can determine whether quest for designation that contains the a drug qualifies for MUMS-drug des- following information: ignation as a minor use in a major spe- (1) A request for designation of a new cies under section 573 of the act, the animal drug for a minor use or use in sponsor shall include in its request to a minor species, which must be spe- FDA for MUMS-drug designation under cific. § 516.20 documentation demonstrating (2) The name and address of the spon- that the use is limited to a small num- sor; the name of the sponsor’s primary ber of animals (annualized). This docu- contact person and/or permanent-resident U.S. agent including title, ad- mentation must include the following dress, and telephone number; the estab- information: lished name (and proprietary name, if (a) The estimated total number of any) of the active pharmaceutical in- animals to which the drug could poten- gredient of the drug; and the name and tially be administered on an annual address of the source of the active basis for the treatment, control, or pre- pharmaceutical ingredient of the drug. vention of the disease or condition for (3) A description of the proposed in- which the drug is being developed, intended use for which the drug is being cluding animals administered the drug or will be investigated. as part of herd or flock treatment, to- (4) A description of the drug and dos- gether with a list of the sources (in- age form. cluding dates of information provided (5) A discussion of the scientific ra- and literature citations) for the esti- tionale for the intended use of the mate. drug; specific reference, including (b) The estimated total number of date(s) of submission, to all data from animals referred to in paragraph (a) of nonclinical laboratory studies, clinical this section may be further reduced to investigations, copies of pertinent un- only a subset of the estimated total published and published papers, and number of animals if administration of other relevant data that are available to the sponsor, whether positive, nega- the drug is only medically justified for tive, or inconclusive. this subset. To establish this, reques- (6) A specific description of the prod- tors must demonstrate that adminis- uct development plan for the drug, its tration of the drug to animals subject dosage form, and its intended use. to the disease or condition for which (7) If the drug is intended for a minor the drug is being developed other than use in a major species, documentation the subset is not medically justified. in accordance with § 516.21, with ap- The sponsor must also include a list of

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the sources (including dates of infor- § 516.25 Refusal to grant MUMS-drug mation provided and literature cita- designation. tions) for the justification that admin- (a) FDA will refuse to grant a request istration of the drug to animals other for MUMS-drug designation if any of than the targeted subset is medically the following reasons apply: inappropriate. (1) The drug is not intended for use in a minor species or FDA determines [72 FR 41017, July 26, 2007, as amended at 74 that there is insufficient evidence to FR 43050, Aug. 25, 2009] demonstrate that the drug is intended § 516.22 Permanent-resident U.S. agent for a minor use in a major species. for foreign sponsor. (2) The drug is the same drug in the same dosage form for the same in- Every foreign sponsor that seeks tended use as one that already has a MUMS-drug designation shall name a MUMS-drug designation but has not permanent resident of the United yet been conditionally approved or ap- States as the sponsor’s agent upon proved. whom service of all processes, notices, (3) The drug is the same drug in the orders, decisions, requirements, and same dosage form for the same in- other communications may be made on tended use as one that is already condi- behalf of the sponsor. Notifications of tionally approved or approved. A drug changes in such agents or changes of that FDA has found to be functionally address of agents should preferably be superior is not considered the same provided in advance, but not later than drug as an already conditionally ap- 60 days after the effective date of such proved or approved drug even if it is changes. The permanent-resident U.S. otherwise the same drug in the same agent may be an individual, firm, or dosage form for the same intended use. domestic corporation and may rep- (4) The sponsor has failed to provide: resent any number of sponsors. The (i) A credible scientific rationale in support of the intended use, name and address of the permanent- (ii) Sufficient information about the resident U.S. agent shall be provided to product development plan for the drug, the Director of the Office of Minor Use its dosage form, and its intended use to and Minor Species Animal Drug Devel- establish that adherence to the plan opment. can lead to successful drug development in a timely manner, and § 516.23 Timing of requests for MUMS- (iii) Any other information required drug designation. under § 516.20. A sponsor may request MUMS-drug (b) FDA may refuse to grant a re- designation at any time in the drug de- quest for MUMS-drug designation if velopment process prior to the submis- the request for designation contains an sion of an application for either condi- untrue statement of material fact or tional approval or approval of the omits material information. MUMS drug for which designation is being requested. § 516.26 Amendment to MUMS-drug designation. § 516.24 Granting MUMS-drug designa- (a) At any time prior to conditional tion. approval or approval of an application for a MUMS-designated drug, the spon- (a) FDA may grant the request for sor may apply for an amendment to the MUMS-drug designation if none of the designated intended use if the proposed reasons described in § 516.25 for refusal change is due to new and unexpected to grant such a request apply. findings in research on the drug, infor- (b) When a request for MUMS-drug mation arising from FDA recommenda- designation is granted, FDA will notify tions, or other unforeseen develop- the sponsor in writing and will give ments. public notice of the MUMS-drug des- (b) FDA will grant the amendment if ignation in accordance with § 516.28. it finds: (1) That the initial designation request was made in good faith;

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(2) That the amendment is intended (v) The name and address of a new to make the MUMS-drug designated in- primary contact person or permanent tended use conform to the results of resident U.S. agent; and new and unexpected findings in re- (vi) Evidence that the new sponsor is search on the drug, information arising capable of actively pursuing approval from FDA recommendations, or other with due diligence. unforeseen developments; and (b) No sponsor may relieve itself of (3) In the case of a minor use, that as responsibilities under the act or under of the date of the submission of the this subpart by assigning rights to an- amendment request, the amendment other person without: would not result in the intended use of (1) Assuring that the new sponsor the drug no longer being considered a will carry out such responsibilities; minor use. and (2) Obtaining prior permission from § 516.27 Change in sponsorship. FDA. (a) A sponsor may transfer sponsor- § 516.28 Publication of MUMS-drug ship of a MUMS-designated drug to an- designations. other person. A change of sponsorship will also transfer the designation sta- FDA will periodically update a pub- tus of the drug which will remain in ef- licly available list of MUMS-designated fect for the new sponsor subject to the drugs. This list will be placed on file at same conditions applicable to the the FDA Division of Dockets Manage- ment, and will contain the following former sponsor provided that at the information for each MUMS-designated time of a potential transfer, the new drug: and former sponsors submit the fol- (a) The name and address of the spon- lowing information in writing and ob- sor; tain permission from FDA: (b) The established name and trade (1) The former sponsor shall submit a name, if any, of the drug; letter to FDA that documents the (c) The dosage form of the drug; transfer of sponsorship of the MUMS- designated drug. This letter shall speci- (d) The species and the proposed in- fy the date of the transfer. The former tended use for which MUMS-drug designation was granted; and sponsor shall also certify in writing to FDA that a complete copy of the re- (e) The date designation was granted. quest for MUMS-drug designation, in- § 516.29 Termination of MUMS-drug cluding any amendments to the re- designation. quest, and correspondence relevant to the MUMS-drug designation, has been (a) The sponsor of a MUMS-des- provided to the new sponsor. ignated drug must notify FDA of any decision to discontinue active pursuit (2) The new sponsor shall submit a of conditional approval or approval of letter or other document containing such MUMS drug. FDA must terminate the following information: the designation upon such notification. (i) A statement accepting the MUMS- (b) A conditionally-approved or ap- drug designated file or application; proved MUMS-designated drug sponsor (ii) The date that the change in spon- must notify FDA at least 1 year before sorship is intended to be effective; it intends to discontinue the manufac- (iii) A statement that the new spon- ture of such MUMS drug. FDA must sor has a complete copy of the request terminate designation upon such noti- for MUMS-drug designation, including fication. any amendments to the request and (c) MUMS designation shall termi- any correspondence relevant to the nate upon the expiration of any appli- MUMS-drug designation; cable period of exclusive marketing (iv) A statement that the new spon- rights under this subpart. sor understands and accepts the re- (d) FDA may terminate designation sponsibilities of a sponsor of a MUMS- if it independently determines that the designated drug established elsewhere sponsor is not actively pursuing condi- in this subpart; tional approval or approval with due

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diligence. At a minimum, due diligence tice of the termination of the MUMS- must be demonstrated by: drug designation. (1) Submission of annual progress reports in a timely manner in accordance § 516.30 Annual reports for a MUMS- with § 516.30 that demonstrate that the designated drug. sponsor is progressing in accordance Within 14 months after the date on with the drug development plan sub- which a MUMS drug is granted des- mitted to the agency under § 516.20 and ignation and annually thereafter until (2) Compliance with all applicable re- approval, the sponsor of a MUMS-des- quirements of part 511 of this chapter. ignated drug shall submit a brief (e) Designation of a conditionally ap- progress report on the drug to the in- proved or approved MUMS-designated vestigational new animal drug file ad- drug and the associated exclusive mar- dressed to the Director of the Office of keting rights may be terminated if the Minor Use and Minor Species Animal sponsor is unable to provide sufficient Drug Development that includes the quantities of the drug to meet the following information: needs for which it is designated. (a) A short account of the progress of (f) FDA may also terminate MUMS- drug development including a descrip- drug designation for any drug if the tion of studies initiated, ongoing, and agency finds that: completed, and a short summary of the (1) The request for designation con- status or results of such studies; tained an untrue statement of material (b) A description of the investiga- fact; or tional plan for the coming year, as well (2) The request for designation omit- as any anticipated difficulties in devel- ted material information required by opment, testing, and marketing; and this subpart; or (c) A brief discussion of any changes (3) FDA subsequently finds that the that may affect the MUMS-designated drug in fact had not been eligible for drug status of the product. For exam- MUMS-drug designation at the time of ple, situations in which testing data submission of the request; demonstrate that the proposed in- (4) The same drug, in the same dos- tended use is inappropriate due to un- age form, for the same intended use be- expected issues of safety or effective- comes conditionally approved or ap- ness. proved for another sponsor; or (5) FDA withdraws the conditional § 516.31 Scope of MUMS-drug exclusive approval or approval of the application marketing rights. for the new animal drug. (a) After conditional approval or ap- (g) For a conditionally approved or proval of an application for a MUMS- approved drug, termination of MUMS- designated drug in the dosage form and drug designation also terminates the for the intended use for which MUMS- sponsor’s exclusive marketing rights drug designation has been granted, for the drug but does not withdraw the FDA will not conditionally approve or conditional approval or approval of the approve another application or abbre- drug’s application. viated application for the same drug in (h) Where a drug has been MUMS-des- the same dosage form for the same in- ignated for a minor use in a major spe- tended use before the expiration of 7 cies, its designation will not be termi- years after the date of conditional ap- nated on the grounds that the number proval or approval as stated in the ap- of animals to which the drug could po- proval letter from FDA, except that tentially be administered on an annual such an application can be condi- basis for the treatment, control, or pre- tionally approved or approved sooner vention of the disease or condition for if, and at such time as, any of the fol- which the drug is being developed, in- lowing occurs: cluding animals administered the drug (1) FDA terminates the MUMS-drug as part of herd or flock treatment, sub- designation and associated exclusive sequently increases. marketing rights under § 516.29; or (i) When a MUMS-drug designation is (2) FDA withdraws the conditional terminated, FDA will notify the spon- approval or approval of the application sor in writing and will give public no- for the drug for any reason; or

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(3) The sponsor with exclusive mar- sure the availability of sufficient quan- keting rights provides written consent tities of the MUMS-designated drug to FDA to conditionally approve or ap- within a reasonable time to meet the prove another application before the needs for which the drug was des- expiration of 7 years; or ignated; or (4) The sponsor fails to assure a suffi- (2) Provide FDA in writing the spon- cient quantity of the drug in accord- sor’s consent for the conditional ap- ance with section 573 of the act and proval or approval of other applica- § 516.36. tions for the same drug before the expi- (b) If an application for a MUMS drug ration of the 7-year period of exclusive cannot be approved until the expira- marketing rights. tion of the period of exclusive mar- (b) If, within the time that FDA keting of a MUMS-designated drug, specifies, the sponsor fails to consent FDA will so notify the sponsor in writ- to the conditional approval or approval ing. of other applications and if FDA finds that the sponsor has not shown that it § 516.34 FDA recognition of exclusive can assure the availability of sufficient marketing rights. quantities of the MUMS-designated (a) FDA will send the sponsor (or the drug to meet the needs for which the permanent-resident U.S. agent, if ap- drug was designated, FDA will issue a plicable) timely written notice recog- written order terminating designation nizing exclusive marketing rights when of the MUMS drug and the associated an application for a MUMS-designated exclusive marketing rights. This order drug has been conditionally approved will state FDA’s findings and conclu- or approved. The written notice will in- sions and will constitute final agency form the sponsor of the requirements action. An order terminating designa- for maintaining MUMS-designated tion and associated exclusive mar- drug exclusive marketing rights for the keting rights may issue whether or not full 7-year term. This notice will gen- there are other sponsors that can as- erally be contained in the letter condi- sure the availability of alternative tionally approving or approving the ap- sources of supply. Such an order will plication. not withdraw the conditional approval (b) When an application is condi- or approval of an application. Once ter- tionally approved or approved for a minated under this section, neither MUMS-designated drug that qualifies designation, nor exclusive marketing for exclusive marketing rights, FDA rights may be reinstated. will publish this information in the FEDERAL REGISTER at the time of the § 516.52 Availability for public disclo- conditional approval or approval. This sure of data and information in re- notice will generally be contained in quests. the notice of conditional approval or (a) FDA will not publicly disclose the approval of the application. existence of a request for MUMS-drug designation under section 573 of the act § 516.36 Insufficient quantities of prior to final FDA action on the re- MUMS-designated drugs. quest unless the existence of the re- (a) Under section 573 of the act, quest has been previously publicly dis- whenever FDA has reason to believe closed or acknowledged. that sufficient quantities of a condi- (b) Whether or not the existence of a tionally-approved or approved, MUMS- pending request for designation has designated drug to meet the needs for been publicly disclosed or acknowl- which the drug was designated cannot edged, no data or information in the re- be assured by the sponsor, FDA will so quest are available for public disclo- notify the sponsor of this possible insure prior to final FDA action on the sufficiency and will offer the sponsor request. the following options, one of which (c) Except as provided in paragraph must be exercised by a time that FDA (d) of this section, upon final FDA ac- specifies: tion on a request for designation, the (1) Provide FDA information and public availability of data and informa- data regarding how the sponsor can as- tion in the request will be determined

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in accordance with part 20 of this chap- (g) Records and reports. ter and other applicable statutes and regulations. § 516.115 Definitions. (d) In accordance with § 516.28, FDA (a) The following definitions of terms will make a cumulative list of all apply only in the context of subpart C MUMS-drug designations available to of this part: the public and update such list periodi- Director OMUMS means the Director cally. In accordance with § 516.29, FDA of the Office of Minor Use and Minor will give public notice of the termi- Species Animal Drug Development of nation of all MUMS-drug designations. the FDA Center for Veterinary Medi- cine. Subpart C—Index of Legally Mar- Holder means the requestor of an keted Unapproved New Ani- index listing after the request is grant- mal Drugs for Minor Species ed and the new animal drug is added to the index. Index means FDA’s list of legally SOURCE: 72 FR 69121, Dec. 6, 2007, unless otherwise noted. marketed unapproved new animal drugs for minor species. § 516.111 Scope of this subpart. Intended use has the same meaning as This subpart implements section 572 that given in § 516.13 of this chapter. of the act and provides standards and Qualified expert panel means a panel procedures to establish an index of le- that is composed of experts qualified gally marketed unapproved new animal by scientific training and experience to drugs. This subpart applies only to evaluate the target animal safety and minor species and not to minor use in effectiveness of a new animal drug major species. This index is only avail- under consideration for indexing. able for new animal drugs intended for Requestor means the person making a use in a minor species for which there request for determination of eligibility is a reasonable certainty that the ani- for indexing or a request for addition mal or edible products from the animal to the index. will not be consumed by humans or Transgenic animal means an animal food-producing animals and for new whose genome contains a nucleotide se- animal drugs intended for use only in a quence that has been intentionally hatchery, tank, pond, or other similar modified in vitro, and the progeny of contained man-made structure in an such an animal, provided that the term early, nonfood life stage of a food-pro- ‘transgenic animal’ does not include an ducing minor species, where safety for animal of which the nucleotide se- humans is demonstrated in accordance quence of the genome has been modi- with the standard of section 512(d) of fied solely by selective breeding. the act (including, for an antimicrobial (b) The definitions of the following new animal drug, with respect to anti- terms are given in § 514.3 of this chap- microbial resistance). The index shall ter: not include a new animal drug that is Adverse drug experience. contained in, or a product of, a Product defect/manufacturing defect. transgenic animal. Among its topics, Serious adverse drug experience. this subpart sets forth the standards Unexpected adverse drug experience. and procedures for: (c) The definitions of the following (a) Investigational exemptions for in- terms are given in § 516.3 of this chap- dexing purposes; ter: (b) Submissions to FDA of requests Same dosage form. for determination of eligibility of a Same drug. new animal drug for indexing; Same intended use. (c) Establishment and operation of expert panels; § 516.117 Submission of correspond- (d) Submissions to FDA of requests ence under this subpart. for addition of a new animal drug to Unless directed otherwise by FDA, the index; all correspondence relating to any as- (e) Modifications to index listings; pect of the new animal drug indexing (f) Publication of the index; and process described in this subpart must

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be addressed to the Director, OMUMS. teria, denying a request for addition to The initial correspondence for a par- the index, or removing a new animal ticular index listing should include the drug from the index, FDA will give name and address of the authorized written notice that specifies the contact person. Notifications of grounds for the initial decision and changes in such person or changes of provides an opportunity for an infor- address of such person should be pro- mal conference for review of the deci- vided in a timely manner. sion. (b) The written notice will include in- § 516.119 Permanent-resident U.S. formation for scheduling the informal agent for foreign requestors and conference and state that a written re- holders. quest for a conference must be made Every foreign requestor and holder within 60 days of the date FDA sends shall name a permanent resident of the its notice. United States as their agent upon (c) Within 45 days of receiving a re- whom service of all processes, notices, quest for an informal conference, FDA orders, decisions, requirements, and will schedule and hold the informal other communications may be made on conference at a time agreeable to both behalf of the requestor or holder. Noti- FDA and the person making the re- fications of changes in such agents or quest. changes of address of agents should (d) Such an informal conference will preferably be provided in advance, but be conducted by a presiding officer who not later than 60 days after the effec- will be the Director of the Center for tive date of such changes. The perma- Veterinary Medicine or his or her des- nent resident U.S. agent may be an in- ignee, excluding the Director of the Of- dividual, firm, or domestic corporation fice of Minor Use and Minor Species and may represent any number of re- Animal Drug Development and other questors or holders. The name and ad- persons significantly involved in the dress of the permanent-resident U.S. initial decision. agent shall be submitted to the Direc- (e) The person requesting an informal tor, OMUMS, and included in the index conference must provide a written re- file. sponse to FDA’s initial decision at least 2 weeks prior to the date of the § 516.121 Meetings. scheduled meeting. Generally, this (a) A requestor or potential requestor written response would be attached to is entitled to one or more meetings to the request for an informal conference. discuss the requirements for indexing a At the option of the person requesting new animal drug. an informal conference, such written (b) Requests for such meetings should response to FDA’s initial decision may be in writing, be addressed to the Di- act in lieu of a face-to-face meeting. In rector, OMUMS, specify the partici- this case, the informal conference will pants attending on behalf of the re- consist of a review by the presiding of- questor or potential requestor, and ficer of the submitted written response. contain a proposed agenda for the (f) The purpose of an informal con- meeting. ference is to discuss scientific and fac- (c) Within 30 days of receiving a re- tual issues. It will involve a discussion quest for a meeting, FDA will attempt of FDA’s initial decision and any writ- to schedule the meeting at a time ten response to that decision. agreeable to both FDA and the person (g) Internal agency review of a deci- making the request. sion must be based on the information in the administrative file. If the person § 516.123 Informal conferences regard- requesting an informal conference pre- ing agency administrative actions. sents new information not in the file, (a) Should FDA make an initial deci- the matter will be returned to the ap- sion denying a request for determina- propriate lower level in the agency for tion of eligibility for indexing, termi- reevaluation based on the new informa- nating an investigational exemption, tion. determining that a qualified expert (h) Informal conferences under this panel does not meet the selection cri- part are not subject to the separation

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of functions rules in § 10.55 of this chap- animal drug through its manufacture ter. and use under section 572(c)(1)(F) of the (i) The rules of evidence do not apply act; to informal conferences. No motions or (3) Conducting an environmental as- objections relating to the admissibility sessment under section 572(c)(1)(E) of of information and views will be made the act; or or considered, but any party to the (4) Obtaining approval of a new ani- conference may comment upon or mal drug application or abbreviated rebut all such data, information and new animal drug application under sec- views. tion 512(b) of the act. (j) [Reserved] (b) Correspondence and information (k) The presiding officer will prepare associated with investigations de- a written report regarding the subject scribed in paragraph (a) of this section of the informal conference that states shall not be sent to the Director, and describes the basis for his or her OMUMS, but shall be submitted to findings. Whenever time permits, the FDA in accordance with the provisions parties to the informal conference will of part 511 of this chapter. have 30 days to review and comment on (c) The investigational use of a new the report. animal drug or animal feed bearing or (l) The administrative record of the containing a new animal drug intended informal conference will consist of: solely for investigational use in minor (1) The notice providing an oppor- species, other than for an investiga- tunity for an informal conference and tional use described in paragraph (a) of the written response to the notice. this section, shall meet the require- (2) All written information and views ments of this section. For such inves- submitted to the presiding officer at tigations, all provisions of part 511 of the conference or, at the discretion of this chapter apply with the following the presiding officer, thereafter. modifications: (3) The presiding officer’s written re- (1) Under § 511.1(a)(1) of this chapter, port. the label statement is as follows: (4) All correspondence and memo- randa of any and all meetings between ‘‘Caution. Contains a new animal the participants and the presiding offi- drug for investigational use only in cer. laboratory animals or for tests in vitro in support of index listing. Not for use (m) The administrative record of the in humans.’’ informal conference is closed to the submission of information at the close (2) Under § 511.1(b)(1) of this chapter, of the conference, unless the presiding the label statement is as follows: officer specifically permits additional ‘‘Caution. Contains a new animal time for further submission. drug for use only in investigational (n) The administrative record of the animals in clinical trials in support of informal conference specified herein index listing. Not for use in humans. constitutes the exclusive record for de- Edible products of investigational ani- cision. mals are not to be used for food for humans or other animals unless author- § 516.125 Investigational use of minor ization has been granted by the U.S. species new animal drugs to sup- Food and Drug Administration or by port indexing. the U.S. Department of Agriculture.’’ (a) The investigational use of a new (3) Under § 511.1(b)(4) of this chapter, animal drug or animal feed bearing or the notice is titled ‘‘Notice of Claimed containing a new animal drug intended Investigational Exemption for a New solely for investigational use in minor Animal Drug for Index Listing’’ and is species shall meet the requirements of submitted in duplicate to the Director, part 511 of this chapter if the investiga- OMUMS. tional use is for the purpose of: (4) Under § 511.1(c)(3) of this chapter, (1) Demonstrating human food safety if an investigator is determined to be under section 572(a)(1)(B) of the act; ineligible to receive new animal drugs, (2) Demonstrating safety with re- each ‘‘Notice of Claimed Investiga- spect to individuals exposed to the new tional Exemption for a New Animal

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Drug for Index Listing’’ and each re- uses and/or multiple minor species can- quest for indexing shall be examined not be granted in any part, the entire with respect to the reliability of infor- request will be denied. mation submitted by the investigator. (c) A requestor must submit two cop- (5) Under § 511.1(c)(4) and (d)(2) of this ies of a dated request signed by the au- chapter, with respect to termination of thorized contact person for determina- exemptions, the sponsor of an inves- tion of eligibility for indexing that tigation shall not be granted an oppor- contains the following: tunity for a regulatory hearing before (1) Identification of the minor species FDA pursuant to part 16 of this chap- or groups of minor species for which ter. Instead, the sponsor shall have an the new animal drug is intended; opportunity for an informal conference (2) Information regarding drug com- as described in § 516.123. ponents and composition; (6) Under § 511.1(c)(5) of this chapter, (3) A statement of the intended use(s) if the Commissioner of Food and Drugs of the new animal drug in the identi- determines, after the unreliable data fied minor species or groups of minor submitted by the investigator are species; eliminated from consideration, that (4) A statement of the proposed con- the data remaining are such that a re- ditions of use associated with the stat- quest for addition to the index would ed intended use(s) of the new animal have been denied, FDA will remove the drug, including the proposed dosage, new animal drug from the index in ac- route of administration, contraindica- cordance with § 516.167. tions, warnings, and any other signifi- (d) The investigational use of a new cant limitations associated with the animal drug or animal feed bearing or intended use(s) of the new animal drug; containing a new animal drug subject (5) A brief discussion of the need for to paragraph (c) of this section shall the new animal drug for the intended not be subject to the good laboratory use(s); practice requirements in part 58 of this chapter. (6) An estimate of the anticipated an- (e) Correspondence and information nual distribution of the new animal associated with investigations de- drug, in terms of the total quantity of scribed in paragraph (c) of this section active ingredient, after indexing; shall be sent to the Director, OMUMS, (7) Information to establish that the in accordance with the provisions of new animal drug is intended for use: this section. (i) In a minor species for which there is a reasonable certainty that the ani- § 516.129 Content and format of a re- mal or edible products from the animal quest for determination of eligi- will not be consumed by humans or bility for indexing. food-producing animals; or (a) Each request for determination of (ii) In a hatchery, tank, pond, or eligibility: other similar contained man-made (1) May involve only one drug (or one structure in (which includes on) an combination of drugs) in one dosage early, non-food life stage of a food-pro- form; ducing minor species, and information (2) May not involve a new animal to demonstrate food safety in accord- drug that is contained in or a product ance with the standards of section of a transgenic animal; 512(d) of the act and § 514.111 of this (3) May not involve the same drug in chapter (including, for an anti- the same dosage form for the same in- microbial new animal drug, with re- tended use as a drug that is already ap- spect to antimicrobial resistance); proved or conditionally approved; and (8) A description of the methods used (4) Must be submitted separately. in, and the facilities and controls used (b) A request for determination of eli- for, the manufacture, processing and gibility for indexing may involve mul- packing of the new animal drug suffi- tiple intended uses and/or multiple cient to demonstrate that the re- minor species. However, if a request for questor has established appropriate determination of eligibility for index- specifications for the manufacture and ing that contains multiple intended control of the new animal drug and

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that the requestor has an under- sufficient evidence to demonstrate standing of current good manufac- safety for humans in accordance with turing practices; the standard of section 512(d) of the act (9) Either a claim for categorical ex- and § 514.111 of this chapter (including, clusion under § 25.30 or § 25.33 of this for an antimicrobial new animal drug, chapter or an environmental assess- with respect to antimicrobial resist- ment under § 25.40 of this chapter; ance); (10) Information sufficient to support (3) The new animal drug is contained the conclusion that the new animal in or is a product of a transgenic ani- drug is safe under section 512(d) of the mal; act with respect to individuals exposed (4) There is insufficient information to the new animal drug through its manufacture and use; and to demonstrate that the requestor has (11) The name and address of the con- established appropriate specifications tact person or permanent-resident U.S. for the manufacture and control of the agent. new animal drug and that the requestor has an understanding of cur- § 516.131 Refuse to file a request for rent good manufacturing practices; determination of eligibility for in- (5) The requester fails to submit an dexing. adequate environmental assessment (a) If a request for determination of under § 25.40 of this chapter or fails to eligibility for indexing contains all of provide sufficient information to estab- the information required by § 516.129, lish that the requested action is sub- FDA shall file it, and the filing date ject to categorical exclusion under shall be the date FDA receives the re- § 25.30 or § 25.33 of this chapter; quest. (6) There is insufficient information (b) If a request for a determination of to determine that the new animal drug eligibility lacks any of the information is safe with respect to individuals ex- required by § 516.129, FDA will not file posed to the new animal drug through it, but will inform the requestor in its manufacture or use; or writing within 30 days of receiving the (7) The request for determination of request as to what information is lacking. eligibility for indexing fails to contain any other information required under § 516.133 Denying a request for deter- the provisions of § 516.129. mination of eligibility for indexing. (b) FDA may deny a request for de- (a) FDA will deny a request for deter- termination of eligibility for indexing mination of eligibility for indexing if it if it contains any untrue statement of determines upon the basis of the re- a material fact or omits material infor- quest evaluated together with any mation. other information before it with re- (c) When a request for determination spect to the new animal drug that: of eligibility for indexing is denied, (1) The same drug in the same dosage FDA will notify the requestor in ac- form for the same intended use is al- cordance with § 516.137. ready approved or conditionally approved; § 516.135 Granting a request for deter- (2) There is insufficient information mination of eligibility for indexing. to demonstrate that the new animal (a) FDA will grant the request for de- drug is intended for use: termination of eligibility for indexing (i) In a minor species for which there if none of the reasons described in is a reasonable certainty that the ani- § 516.133 for denying such a request ap- mal or edible products from the animal plies. will not be consumed by humans or food-producing animals, or (b) When a request for determination (ii) In a hatchery, tank, pond, or of eligibility for indexing is granted, other similar contained man-made FDA will notify the requestor in ac- structure in (which includes on) an cordance with § 516.137. early, non-food life stage of a food-producing minor species, and there is in-

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§ 516.137 Notification of decision re- ing the new animal drug proposed for garding eligibility for indexing. addition to the index. (a) Within 90 days after the filing of (3) A qualified expert panel member a request for a determination of eligi- may not be an FDA employee. bility for indexing based on (4) A qualified expert panel must § 516.129(c)(7)(i), or 180 days for a re- have at least three members. quest based on § 516.129(c)(7)(ii), FDA (5) A qualified expert panel must shall grant or deny the request, and no- have members with a range of expertise tify the requestor of FDA’s decision in such that the panel, as a whole, is writing. qualified by training and experience to evaluate the target animal safety and (b) If FDA denies the request, FDA effectiveness of the new animal drug shall provide due notice and an oppor- under consideration. tunity for an informal conference as (6) Unless FDA makes a determina- described in § 516.123 regarding its deci- tion to allow participation notwith- sion. A decision of FDA to deny a re- standing an otherwise disqualifying fi- quest for determination of eligibility nancial interest, a qualified expert for indexing following an informal con- panel member must not have a conflict ference shall constitute final agency of interest or the appearance of a con- action subject to judicial review. flict of interest, as described in paragraph (g) of this section. § 516.141 Qualified expert panels. (c) Requestor responsibilities. (1) The (a) Establishment of a qualified expert requestor must: panel. Establishing a qualified expert (i) Choose members for the qualified panel is the first step in the process of expert panel in accordance with selec- requesting the addition of a new ani- tion criteria listed in paragraph (b) of mal drug to the index. A qualified ex- this section. pert panel may not be established until (ii) Provide each potential expert FDA has determined that the new ani- panel member a copy of section 572 of mal drug is eligible for indexing. The the act (the indexing provisions of the requestor must choose members for the statute) and this subpart and obtain qualified expert panel in accordance certification that he or she has a work- with selection criteria listed in para- ing knowledge of the information. graph (b) of this section and submit in- (iii) Provide each potential expert formation about these proposed mem- panel member a written statement de- bers to FDA. FDA must determine scribing the purpose and scope of his or whether the proposed qualified expert her participation on the qualified ex- panel meets the selection criteria prior pert panel and obtain certification that to the panel beginning its work. Quali- he or she has read and understood the fied expert panels operate external to information. The written statement FDA and are not subject to the Federal should describe the duties and respon- Advisory Committee Act, as amended, sibilities of qualified expert panels and 5 U.S.C. App. their members established by para- (b) Criteria for the selection of a quali- graphs (e) and (f) of this section, in- fied expert panel. (1) A qualified expert cluding the need to prepare a written panel member must be an expert quali- report under § 516.143. fied by training and experience to (iv) Obtain information from each po- evaluate a significant aspect of target tential expert panel member dem- animal safety or effectiveness of the onstrating that he or she is qualified new animal drug under consideration. by training and experience to evaluate (2) A qualified expert panel member the target animal safety and effective- must certify that he or she has a work- ness of the new animal drug under con- ing knowledge of section 572 of the act sideration. This information can be ob- (the indexing provisions of the statute) tained from a comprehensive cur- and this subpart, and that he or she has riculum vitae or similar document. also read and understood a clear writ- (v) Notify each potential expert panel ten statement provided by the re- member that he or she must submit in- questor stating his or her duties and formation relating to potential conflict responsibilities with respect to review- of interest directly to FDA in a timely

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manner, as required in paragraph (e)(6) FDA will provide due notice and an op- of this section. portunity for an informal conference as (2) The requestor must submit, in described in § 516.123. A determination writing, the names and addresses of the by FDA that a proposed qualified ex- proposed qualified expert panel mem- pert panel does not meet the selection bers and sufficient information about criteria following an informal con- each proposed member for FDA to de- ference shall constitute final agency termine whether the panel meets the action subject to judicial review. selection criteria listed in paragraphs (2) If FDA determines that a qualified (b)(1) through (b)(5) of this section. expert panel no longer meets the selec- (3) After FDA has determined that tion criteria listed in paragraph (b) of the qualified expert panel meets the se- this section or that the panel or its lection criteria, the requestor must members are not in compliance with provide to the panel all information the requirements of this section, the known by the requestor that is rel- agency will expeditiously inform the evant to a determination of the target requestor, in writing, of this deter- animal safety and the effectiveness of mination and provide due notice and an the new animal drug at issue. In addi- opportunity for an informal conference tion, the requestor must notify FDA of as described in § 516.123. A determina- the name of the qualified expert panel tion by FDA, following an informal leader. conference, that a qualified expert (4) The requestor must immediately panel no longer meets the selection cri- notify FDA if it believes a qualified ex- teria listed in paragraph (b) of this sec- pert panel member no longer meets the tion or that the panel or its members selection criteria listed in paragraph are not in compliance with the require- (b) of this section or is otherwise not in ments of this section shall constitute compliance with the requirements of final agency action subject to judicial this section. review. (5) If a qualified expert panel member (e) Responsibilities of a qualified expert cannot complete the review for which panel member. A qualified expert panel he or she was selected, the requestor member must do the following: must either choose a replacement or justify the continued work of the panel (1) Continue to meet all selection cri- in the absence of the lost panelist. In teria described in paragraph (b) of this either case, the requestor must submit section. sufficient information for FDA to de- (2) Act in accordance with generally termine whether the proposed revised accepted professional and ethical busi- qualified expert panel meets the selec- ness practices. tion criteria listed in paragraphs (b)(1) (3) Review all information relevant through (b)(5) of this section. to a determination of the target ani- (6) The requestor must keep copies of mal safety and effectiveness of the new all information provided to, or received animal drug provided by the requestor. from, qualified expert panel members, The panel should also consider all rel- including the written report, for 2 evant information otherwise known by years after the completion of the re- the panel members, including anec- port, or the product is added to the dotal information. index, whichever occurs later, and (4) Participate in the preparation of make them available to a duly author- the written report of the findings of ized employee of the agency at all rea- the qualified expert panel, described in sonable times. § 516.143. (d) FDA responsibilities. (1) FDA will (5) Sign, or otherwise approve in determine whether the requestor’s pro- writing, the written report. Such sig- posed qualified expert panel meets the nature or other written approval will selection criteria listed in paragraph serve as certification that the written (b) of this section. FDA will expedi- report meets the requirements of the tiously inform the requestor, in writ- written report in § 516.143. ing, of its determination. If FDA deter- (6) Provide the information relating mines that the qualified expert panel to potential conflict of interest de- does not meet the selection criteria, scribed in paragraph (g) of this section

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to FDA for its consideration. Such in- rectly or indirectly through another formation should be submitted directly entity, such as a university). to the Director, OMUMS, when notified (ii) Has any employment, contrac- by the requestor. tual, or other financial arrangement (7) Immediately notify the requestor with the requestor other than receiving and FDA of any change in conflict of a reasonable fee for serving as a mem- interest status. ber of the qualified expert panel. (8) Certify at the time of submission (iii) Has any ownership or financial of the written report that there has interest in any drug, drug manufac- been no change in conflict of interest turer, or drug distributor which will status, or identify and document to benefit from either a favorable or unfa- FDA any such change. vorable evaluation or opinion. (f) Additional responsibilities of a quali- (iv) Has any ownership or financial fied expert panel leader. (1) The qualified interest in the new animal drug being expert panel leader must ensure that reviewed by the qualified expert panel. the activities of the panel are per- (v) Has participated in the design, formed efficiently and in accordance manufacture, or distribution of any with generally accepted professional drug that will benefit from either a fa- and ethical business practices. vorable or unfavorable opinion of the (2) The qualified expert panel leader qualified expert panel. serves as the principal point of contact (vi) Has provided within 1 year any between representatives of the agency consultative services regarding the new and the panel. animal drug being reviewed by the (3) The qualified expert panel leader qualified expert panel. is responsible for submitting the writ- (vii) Has entered into an agreement ten report and all notes or minutes rein which fees charged or accepted are lating to panel deliberations to the re- contingent upon the panel member questor. making a favorable evaluation or opin- (4) The qualified expert panel leader ion. must maintain a copy of the written (viii) Receives payment for services report and all notes or minutes relat- related to preparing information the ing to panel deliberations that are sub- requestor presents to the qualified ex- mitted to the requestor for 2 years pert panel, other than for services re- after the report is submitted. Such lated to the written report described in records must be made available to a § 516.143. duly authorized employee of the agen- (3) To permit FDA to make a decision cy for inspection at all reasonable regarding potential conflict of interest, times. a potential qualified expert panel mem- (g) Prevention of conflicts of interest. ber must submit to the Director, (1) For the purposes of this subpart, OMUMS, the following information re- FDA will consider a conflict of interest lating to themselves, their spouse, to be any financial or other interest their minor children, their general that could impair a person’s objec- partners, or any organizations in which tivity in serving on the qualified expert they serve as an officer, director, trust- panel or could create an unfair com- ee, general partner or employee, re- petitive advantage for a person or orga- garding the following issues to the ex- nization. tent that they are, in any way, rel- (2) Factors relevant to whether there evant to the subject of the review of is a conflict of interest or the appear- the qualified expert panel: ance of a conflict of interest include (i) Investments (for example, stocks, whether the qualified expert panel bonds, retirement plans, trusts, part- member, their spouse, their minor chil- nerships, sector funds, etc.), including dren, their general partners, or any or- for each the following: Name of the ganizations in which they serve as an firm, type of investment, owner (self, officer, director, trustee, general part- spouse, etc.), number of shares / cur- ner or employee: rent value. (i) Is currently receiving or seeking (ii) Employment (full or part time, funding from the requestor through a current or under negotiation), includ- contract or research grant (either di- ing for each the following: Name of the

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firm, relationship (self, spouse, etc.), have read and understood their obliga- position in firm, date employment or tions as an expert panel member, and negotiation began. that they will notify FDA and the re- (iii) Consultant/advisor (current or questor of any change in their conflict under negotiation), including for each of interest status. the following: Name of the firm, topic/ (4) The fact that a qualified expert issue, amount received, date initiated. panel member receives a reasonable fee (iv) Contracts, grants, Cooperation for services as a member of the quali- Research and Development Agreement fied expert panel, provided that the fee (CRADAs) (current or under negotia- is no more than commensurate with tion), including for each the following: the value of the time that the member Type of agreement, product under devotes to the review process, does not study and indications, amount of remu- constitute a conflict of interest or the neration (institution/self), time period, appearance of a conflict of interest. sponsor (government, firm, institution, individual), role of the person (site in- § 516.143 Written report. vestigator, principal investigator, co- The written report required in investigator, partner, no involvement, § 516.145(b)(3) shall: other), awardee. (a) Be written in English by a quali- (v) Patents/royalties/trademarks, in- fied expert panel meeting the require- cluding for each the following: Descrip- ments of § 516.141; tion, name of firm involved, income received. (b) Describe the panel’s evaluation of (vi) Expert witness (last 12 months or all available target animal safety and under negotiation), including for each effectiveness information relevant to the following: For or against, name of the proposed use of the new animal firm, issue, amount received. drug, including anecdotal information; (vii) Speaking/writing (last 12 months (c) For all information considered, or under negotiation), including for including anecdotal information, in- each the following: Firm, topic/issue, clude either a citation to published lit- amount received (honorarium/travel), erature or a summary of the informa- date. tion; (viii) Whether the potential qualified (d) State the panel’s opinion regard- expert panel member, their spouse, ing whether the benefits of using the their minor children, their general new animal drug for the proposed use partners or any organizations in which in a minor species outweigh its risks to they serve as an officer, director, trust- the target animal, taking into account ee, general partner or employee, have the harm being caused by the absence had, at any time in the past, involve- of an approved or conditionally-ap- ment of the kind noted in paragraph proved new animal drug for the minor (g)(3)(i) through (g)(3)(vii) of this sec- species in question; tion with respect to the animal drug (e) Be signed, or otherwise approved that is the subject of the qualified ex- in writing, by all panel members, in ac- pert panel review. cordance with § 516.141; and (ix) Whether there are any other in- (f) If the panel unanimously con- volvements (other kinds of relation- cludes that the benefits of using the ships) that would give the appearance new animal drug for the proposed use of a conflict of interest which have not in a minor species outweigh its risks to been described in paragraph (g)(3)(i) the target animal, taking into account through (g)(3)(viii) of this section. the harm being caused by the absence (x) In all cases, a response of ‘‘no,’’ of an approved or conditionally-ap- ‘‘none,’’ or ‘‘not applicable’’ is satisfac- proved new animal drug for the minor tory when there is no relevant informa- species in question, the written report tion to submit. shall: (xi) A certification statement signed (1) Provide draft labeling that in- by the potential qualified expert panel cludes all conditions of use and limita- member to the effect that all informa- tions of use of the new animal drug tion submitted is true and complete to deemed necessary by the panel to as- the best of their knowledge, that they sure that the benefits of use of the new

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animal drug outweigh the risks, or pro- drug, route of administration, indica- vide narrative information from which tions, and recommended dosage. such labeling can be written by the re- (ii) A list of the names and affili- questor; and ations of the members of the qualified (2) Include a recommendation regard- expert panel, not including their ad- ing whether the new animal drug dresses or other contact information. should be limited to use under the pro- (iii) A summary of the findings of the fessional supervision of a licensed vet- qualified expert panel concerning the erinarian. target animal safety and effectiveness of the drug. § 516.145 Content and format of a re- (iv) Citations of all publicly-available quest for addition to the index. literature considered by the qualified (a) A requestor may request addition expert panel. of a new animal drug to the index only (v) For an early life stage of a food- after the new animal drug has been producing minor species animal, a granted eligibility for indexing. human food safety summary. (b) A requestor shall submit two cop- (c) Upon specific request by FDA, the ies of a dated request signed by the au- requestor shall submit the information thorized contact for addition of a new described in § 516.141 that it submitted animal drug to the index that contains to the qualified expert panel. Any such the following: information not in English should be (1) A copy of FDA’s determination of accompanied by an English trans- eligibility issued under § 516.137; lation. (2) A copy of FDA’s written determination that the proposed qualified § 516.147 Refuse to file a request for expert panel meets the selection cri- addition to the index. teria provided for in § 516.141(b); (a) If a request for addition to the (3) A written report that meets the index contains all of the information requirements of § 516.143; required by § 516.145(b), FDA shall file (4) A proposed index entry that con- it, and the filing date shall be the date tains the information described in FDA receives the request. § 516.157; (5) Proposed labeling, including rep- (b) If a request for addition to the resentative labeling proposed to be index lacks any of the information reused for Type B and Type C medicated quired by § 516.145, FDA will not file it, feeds if the drug is intended for use in but will inform the requestor in writ- the manufacture of medicated feeds; ing within 30 days of receiving the re- (6) Anticipated annual distribution of quest as to what information is lack- the new animal drug, in terms of the ing. total quantity of active ingredient, § 516.149 Denying a request for addi- after indexing; tion to the index. (7) A written commitment to manufacture the new animal drug and ani- (a) FDA will deny a request for addi- mal feeds bearing or containing such tion to the index if it finds the fol- new animal drug according to current lowing: good manufacturing practices; (1) The same drug in the same dosage (8) A written commitment to label, form for the same intended use is al- distribute, and promote the new ani- ready approved or conditionally ap- mal drug only in accordance with the proved; index entry; (2) On the basis of new information, (9) The name and address of the con- the new animal drug no longer meets tact person or permanent-resident U.S. the conditions for eligibility for index- agent; and ing; (10) A draft Freedom of Information (3) The request for indexing fails to summary which includes the following contain information required under the information: provisions of § 516.145; (i) A general information section (4) The qualified expert panel fails to that contains the name and address of meet any of the selection criteria list- the requestor and a description of the ed in § 516.141(b);

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(5) The written report of the qualified § 516.155 Labeling of indexed drugs. expert panel and other information (a) The labeling of an indexed drug available to FDA is insufficient to per- that is found to be eligible for indexing mit FDA to determine that the bene- under § 516.129(c)(7)(i) shall state, fits of using the new animal drug for prominently and conspicuously: ‘‘NOT the proposed use in a minor species APPROVED BY FDA.—Legally marketed outweigh its risks to the target ani- as an FDA indexed product. Extra-label mal, taking into account the harm use is prohibited.’’ ‘‘This product is not to caused by the absence of an approved be used in animals intended for use as or conditionally-approved new animal food for humans or other animals.’’ drug for the minor species in question; (b) The labeling of an indexed drug (6) On the basis of the report of the that was found to be eligible for index- qualified expert panel and other infor- ing for use in an early, non-food life mation available to FDA, the benefits stage of a food-producing minor species of using the new animal drug for the animal, under § 516.129(c)(7)(ii), shall proposed use in a minor species do not state, prominently and conspicuously: outweigh its risks to the target ani- ‘‘NOT APPROVED BY FDA.—Legally mal, taking into account the harm marketed as an FDA indexed product. caused by the absence of an approved Extra-label use is prohibited.’’ or conditionally-approved new animal (c) The labeling of an indexed drug drug for the minor species in question; shall contain such other information as or may be prescribed in the index listing. (7) The request contains any untrue statement of a material fact or omits § 516.157 Publication of the index and material information. content of an index listing. (b) When a request for addition to the (a) FDA will make the list of indexed index is denied, FDA will notify the re- drugs available through the FDA Web questor in accordance with § 516.153. site at http://www.fda.gov. A printed copy can be obtained by writing to the § 516.151 Granting a request for addi- Freedom of Information Staff or by vis- tion to the index. iting FDA’s Freedom of Information (a) FDA will grant the request for ad- Staff’s Public Reading Room at the addition of a new animal drug to the dress listed on the Agency’s Web site at index if none of the reasons described http://www.fda.gov. in § 516.149 for denying such a request (b) The list will contain the following applies. information for each indexed drug: (b) When a request for addition of a (1) The name and address of the per- new animal drug to the index is grant- son who holds the index listing; ed, FDA will notify the requestor in ac- (2) The name of the drug and the in- cordance with § 516.153. tended use and conditions of use for which it is indexed; § 516.153 Notification of decision re- (3) Product labeling; and garding index listing. (4) Conditions and any limitations (a) Within 180 days after the filing of that FDA deems necessary regarding a request for addition of a new animal use of the drug. drug to the index, FDA shall grant or [72 FR 69121, Dec. 6, 2007; 76 FR 31470, June 1, deny the request and notify the re- 2011, as amended at 79 FR 68115, Nov. 14, 2014] questor of FDA’s decision in writing. (b) If FDA denies the request for ad- § 516.161 Modifications to indexed dition of a new animal drug to the drugs. index, FDA shall provide due notice (a) After a drug is listed in the index, and an opportunity for an informal certain modifications to the index list- conference as described in § 516.123. A ing may be requested. Any modifica- decision of FDA to deny a request to tion of an index listing may not cause index a new animal drug following an an indexed drug to be a different drug informal conference shall constitute (or different combination of drugs) or a final agency action subject to judicial different dosage form. If such modifica- review. tion is requested, FDA will notify the

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holder that a new index listing is re- the labeling on or within the indexed quired for the new drug or dosage form. drug package. (b) Modifications to the indexed drug (2) Significant changes. (i) The fol- will fall under one of three categories lowing modifications to an indexed and must be submitted as follows: drug or its labeling may be made only (1) Urgent changes. (i) The following after a request has been submitted to modifications to an indexed drug or its and subsequently granted by FDA: labeling should be made as soon as pos- (A) Addition of an intended use. sible, and a request to modify the in- (B) Addition of a species. dexed drug should be concurrently sub- (C) Addition or alteration of an ac- mitted: tive ingredient. (A) The addition to package labeling, (D) Alteration of the concentration promotional labeling, or prescription of an active ingredient. drug advertising of additional warning, (E) Alteration of dose or dosage regi- contraindication, side effect, or cau- men. tionary information. (F) Alteration of prescription or (B) The deletion from package label- over-the-counter status. ing, promotional labeling, and drug advertising of false, misleading, or unsup- (ii) Each modification described in ported indications for use or claims for paragraph (b)(2)(i) of this section must effectiveness. go through the same review process as (C) Changes in manufacturing meth- an original index listing and is subject ods or controls required to correct to the same standards for review. product or manufacturing defects that (iii) Each submission of a request for may result in serious adverse drug a modification described in paragraph events. (b)(2)(i) of this section should contain (ii) The modifications described in only one type of modification unless paragraph (b)(1)(i) of this section must one modification is actually neces- be submitted to the Director, OMUMS, sitated by another, such as a modifica- in the form of a request for modification of dose necessitated by a modification of an indexed drug, and must con- tion of the concentration of an active tain sufficient information to permit ingredient. Submissions relating to ad- FDA to determine the need for the dition of an intended use for an exist- modification and whether the modi- ing species or addition of a species fication appropriately addresses the should be submitted separately, but need. each such submission may include mul- (iii) FDA will take no action against tiple additional intended uses and/or an indexed drug or index holder solely multiple additional species. because modifications of the kinds de- (3) Minor changes. All modifications scribed in paragraph (b)(1)(i) of this other than those described in para- section are placed into effect by the graphs (b)(1) and (b)(2) of this section holder prior to receipt of a written no- including, but not limited to, formula- tice granting the request if all the fol- tion, labeling, and manufacturing lowing conditions are met: methods and controls (at the same (A) A request to modify the indexed level of detail that these were de- drug providing a full explanation of the scribed in the request for determina- basis for the modifications has been tion of eligibility for indexing) must be submitted, plainly marked on the mail- submitted as part of the annual in- ing cover and on the request as follows: dexed drug experience report or as oth- ‘‘Special indexing request— modifica- erwise required by § 516.165. tions being effected;’’ (c) When changes affect the index (B) The holder specifically informs listing, it will be updated accordingly. FDA of the date on which such modifications are to be effected and submits § 516.163 Change in ownership of an two printed copies of any revised label- index file. ing to be placed in use, and (a) A holder may transfer ownership (C) All promotional labeling and all of a drug’s index file to another person. drug advertising are promptly revised (1) The former owner shall submit in consistent with modifications made in writing to FDA a statement that all

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rights in the index file have been trans- (3) The records and reports referred ferred, giving the name and address of to in this section are in addition to the new owner and the date of the those required by the current good transfer. The former owner shall also manufacturing practice regulations in certify that a complete copy of the fol- parts 211, 225, and 226 of this chapter. lowing, to the extent that they exist at (4) FDA will review the records and the time of the transfer of ownership, reports required in this section to de- has been provided to the new owner: termine, or facilitate a determination, (i) The request for determination of whether there may be grounds for re- eligibility; moving a drug from the index under (ii) The request for addition to the section 572(f) of the act. index; (b) Recordkeeping requirements. (1) (iii) Any modifications to the index Each holder of an indexed drug must listing; establish and maintain complete files (iv) Any records and reports under containing full records of all informa- § 516.165; and tion pertinent to the safety or effec- (v) All correspondence with FDA rel- tiveness of the indexed drug. Such evant to the indexed drug and its index records must include information from listing. foreign and domestic sources. (2) The new owner shall submit the (2) The holder must, upon request following information in writing to from any authorized FDA officer or FDA: employee, at all reasonable times, per- (i) The date that the change in own- mit such officer or employee to have ership is effective; access to copy and to verify all such (ii) A statement that the new owner records. has a complete copy of all documents (c) Reporting requirements—(1) Three- listed in paragraph (a)(1) of this section day indexed drug field alert report. The to the extent that they exist at the holder must inform the appropriate time of the transfer of ownership; FDA District Office or local FDA resi- (iii) A statement that the new owner dent post of any product or manufac- understands and accepts the respon- turing defects that may result in seri- sibilities of a holder of an indexed drug; ous adverse drug events within 3 work- (iv) The name and address of a new ing days of first becoming aware that primary contact person or permanent- such a defect may exist. The holder resident U.S. agent; and may initially provide this information (v) A list of labeling changes associ- by telephone or other electronic com- ated with the change of ownership munication means, with prompt writ- (e.g., a new trade name) as draft label- ten followup. The mailing cover must ing, with complete final printed label- be plainly marked ‘‘3–Day Indexed ing to be submitted in the indexed drug Drug Field Alert Report.’’ annual report in accordance with (2) Fifteen-day indexed drug alert re- §§ 516.161 and 516.165. port. The holder must submit a report (b) Upon receiving the necessary in- on each serious, unexpected adverse formation to support a change of own- drug event, regardless of the source of ership of a drug’s index file, FDA will the information. The holder must sub- update its publicly-available listing in mit the report within 15 working days accordance with § 516.157. of first receiving the information. The mailing cover must be plainly marked § 516.165 Records and reports. ‘‘15–Day Indexed Drug Alert Report.’’ (a) Scope and purpose. (1) The record- (3) Annual indexed drug experience re- keeping and reporting requirements of port. The holder must submit this re- this section apply to all holders of in- port every year on the anniversary dexed drugs, including indexed drugs date of the letter granting the request intended for use in medicated feeds. for addition of the new animal drug to (2) A holder is not required to report the index, or within 60 days thereafter. information under this section if the The report must contain data and in- holder has reported the same informa- formation for the full reporting period. tion under § 514.80 of this chapter. Any previously submitted information

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contained in the report must be identi- an appropriate qualifying phrase such fied as such. The holder may ask FDA as ‘‘manufactured for’’ or ‘‘distributed to change the date of submission and, by.’’ after approval of such request, file such (ii) A signed statement by the dis- reports by the new filing date. The re- tributor stating: port must contain the following: (A) The category of the distributor’s (i) The number of distributed units of operations (e.g., wholesale or retail); each size, strength, or potency (e.g., (B) That the distributor will dis- 100,000 bottles of 100 5-milligram tab- tribute the drug only under the indexed lets; 50,000 10-milliliter vials of 5- per- drug labeling; cent solution) distributed during the (C) That the distributor will promote reporting period. This information the indexed drug only for use under the must be presented in two categories: conditions stated in the index listing; Quantities distributed domestically and and quantities exported. This informa- (D) If the indexed drug is a prescription must include any distributor-lation new animal drug, that the dis- beled product. tributor is regularly and lawfully en- (ii) If the labeling has changed since gaged in the distribution or dispensing the last report, include a summary of of prescription products. those changes and the holder’s and dis- (5) Other reporting. FDA may by order tributor’s current package labeling, in- require that a holder submit informa- cluding any package inserts. For large- tion in addition to that required by size package labeling or large shipping this section or that the holder submit cartons, submit a representative copy the same information but at different (e.g., a photocopy of pertinent areas of times or reporting periods. large feed bags). If the labeling has not changed since the last report, include a § 516.167 Removal from the index. statement of such fact. (iii) A summary of any changes made (a) After due notice to the holder of during the reporting period in the the index listing and an opportunity methods used in, and facilities and con- for an informal conference as described trols used for, manufacture, processing, in § 516.123, FDA shall remove a new and packing. This information must be animal drug from the index if FDA presented in the same level of detail finds that: that it was presented in the request for (1) The same drug in the same dosage determination of eligibility for index- form for the same intended use has ing. Do not include changes that have been approved or conditionally ap- already been submitted under § 516.161. proved; (iv) Nonclinical laboratory studies (2) The expert panel failed to meet and clinical data not previously re- the requirements in § 516.141; ported under this section. (3) On the basis of new information (v) Adverse drug experiences not pre- before FDA, evaluated together with viously reported under this section. the evidence available to FDA when (vi) Any other information pertinent the new animal drug was listed in the to safety or effectiveness of the in- index, the benefits of using the new dexed drug not previously reported animal drug for the indexed use do not under this section. outweigh its risks to the target ani- (4) Distributor’s statement. At the time mal, taking into account the harm of initial distribution of an indexed caused by the absence of an approved drug by a distributor, the holder must or conditionally-approved new animal submit a report containing the fol- drug for the minor species in question; lowing: (4) Any of the conditions in (i) The distributor’s current product § 516.133(a)(2), (5), or (6) are present; labeling. This must be identical to that (5) The manufacture of the new ani- in the index listing except for a dif- mal drug is not in accordance with cur- ferent and suitable proprietary name rent good manufacturing practices; (if used) and the name and address of (6) The labeling, distribution, or pro- the distributor. The name and address motion of the new animal drug is not of the distributor must be preceded by in accordance with the index listing;

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(7) The conditions and limitations of edged before an index listing has been use associated with the index listing made public by FDA, no data or infor- have not been followed; or mation contained in the file will be (8) Any information used to support available for public disclosure before the request for addition to the index such index listing is made public, but contains any untrue statement of ma- the agency may, at its discretion, dis- terial fact. close a brief summary of such selected (b) The agency may partially remove portions of the safety and effectiveness an indexing listing if, in the opinion of data as are appropriate for public con- the agency, such partial removal would sideration of a specific pending issue, satisfactorily resolve a safety or effec- e.g., at an open session of a Food and tiveness issue otherwise warranting re- Drug Administration advisory com- moval of the listing under section mittee or pursuant to an exchange of 572(f)(1)(B) of the act. important regulatory information with (c) FDA may immediately suspend a a foreign government. new animal drug from the index if FDA (e) After FDA sends a written notice determines that there is a reasonable to the requestor granting a request for probability that the use of the drug addition to the index, the following would present a risk to the health of data and information in the index file humans or other animals. The agency are available for public disclosure un- will subsequently provide due notice less extraordinary circumstances are and an opportunity for an informal shown: conference as described in § 516.123. (1) All safety and effectiveness data (d) A decision of FDA to remove a and information previously disclosed to new animal drug from the index fol- the public, as defined in § 20.81 of this lowing an informal conference, if any, chapter. shall constitute final agency action (2) A summary or summaries of the subject to judicial review. safety and effectiveness data and information submitted with or incorporated § 516.171 Confidentiality of data and by reference in the index file. Such information in an index file. summaries do not constitute the full (a) For purposes of this section, the information described under section index file includes all data and infor- 572(c) and (d) of the act on which the mation submitted to or incorporated safety or effectiveness of the drug may by reference into the index file, such as be determined. Such summaries will be data and information related to inves- based on the draft Freedom of Informa- tigational use exemptions under tion summary submitted under § 516.125, requests for determination of § 516.145, which will be reviewed and, eligibility for indexing, requests for ad- where appropriate, revised by FDA. dition to the index, modifications to (3) A protocol for a test or study, un- indexed drugs, changes in ownership, less it is shown to fall within the ex- reports submitted under § 516.165, and emption established for trade secrets master files. The availability for public and confidential commercial informa- disclosure of any record in the index tion in § 20.61 of this chapter. file shall be handled in accordance with (4) Adverse reaction reports, product the provisions of this section. experience reports, consumer com- (b) The existence of an index file will plaints, and other similar data and in- not be disclosed by FDA before an formation, after deletion of the fol- index listing has been made public by lowing: FDA, unless it has previously been pub- (i) Names and any information that licly disclosed or acknowledged by the would identify the person using the requestor. product. (c) If the existence of an index file (ii) Names and any information that has not been publicly disclosed or ac- would identify any third party involved knowledged, no data or information in with the report, such as a veterinarian. the index file are available for public (5) A list of all active ingredients and disclosure. any inactive ingredients previously (d) If the existence of an index file disclosed to the public as defined in has been publicly disclosed or acknowl- § 20.81 of this chapter.

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(6) An assay method or other analyt- (2) A final determination is made ical method, unless it serves no regu- that the drug cannot be indexed and all latory or compliance purpose and is legal appeals have been exhausted. shown to fall within the exemption es- (3) The drug has been removed from tablished in § 20.61 of this chapter. the index and all legal appeals have (7) All correspondence and written been exhausted. summaries of oral discussions relating (4) A final determination has been to the index file, in accordance with made that the animal drug is not a new the provisions of part 20 of this chap- animal drug. ter. (f) The following data and informa- Subpart D [Reserved] tion in an index file are not available for public disclosure unless they have Subpart E—Conditionally Ap- been previously disclosed to the public proved New Animal Drugs For as defined in § 20.81 of this chapter, or they relate to a product or ingredient Minor Use and Minor Species that has been abandoned and they no longer represent a trade secret or con- SOURCE: 72 FR 57200, Oct. 9, 2007, unless fidential commercial or financial infor- otherwise noted. mation as defined in § 20.61 of this chap- § 516.1684 Paclitaxel. ter: (1) Manufacturing methods or proc- (a) Specifications. Each vial of powder esses, including quality control proce- contains 60 milligrams (mg) paclitaxel. dures. Each milliliter of constituted solution (2) Production, sales, distribution, contains 1 mg paclitaxel. and similar data and information, ex- (b) Sponsor. See No. 052818 in cept that any compilation of such data 510.600(c) of this chapter. and information aggregated and pre- (c) Conditions of use in dogs—(1) pared in a way that does not reveal Amount. Administer 150 mg per square data or information which is not avail- meter of body surface area intra- able for public disclosure under this venously over 15 to 30 minutes, once provision is available for public disclo- every 3 weeks, for up to 4 doses. sure. (2) Indications for use. For the treat- (3) Quantitative or semiquantitative ment of nonresectable stage III, IV, or formulas. V mammary carcinoma in dogs that (g) Subject to the disclosure provi- have not received previous chemo- sions of this section, the agency shall therapy or radiotherapy. For the treat- regard the contents of an index file as ment of resectable and nonresectable confidential information unless specifi- squamous cell carcinoma in dogs that cally notified in writing by the holder have not received previous chemo- of the right to disclose, to reference, or therapy or radiotherapy. otherwise utilize such information on (3) Limitations. Federal law restricts behalf of another named person. this drug to use by or on the order of a (h) For purposes of this regulation, licensed veterinarian. It is a violation safety and effectiveness data include of Federal law to use this product all studies and tests of an animal drug other than as directed in the labeling. on animals and all studies and tests on [79 FR 18158, Apr. 1, 2014] the animal drug for identity, stability, purity, potency, and bioavailability. § 516.2065 Rabacfosadine. (i) Safety and effectiveness data and (a) Specifications. Each vial of powder information that have not been pre- contains 16.4 milligrams (mg) viously disclosed to the public are rabacfosadine. Each milliliter of con- available for public disclosure at the stituted solution contains 8.2 mg time any of the following events occurs rabacfosadine. unless extraordinary circumstances are (b) Sponsor. See No. 086072 in shown: § 510.600(c) of this chapter. (1) No work is being or will be under- (c) Conditions of use in dogs—(1) taken to have the drug indexed in ac- Amount. Administer rabacfosadine at 1 cordance with the request. mg/kilogram body weight as a 30-

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minute intravenous infusion, once 520.292 Capromorelin. every 3 weeks, for up to 5 doses. 520.301 Caramiphen ethanedisulfonate and (2) Indications for use. For the treat- ammonium chloride tablets. ment of lymphoma in dogs. 520.302 Carnidazole tablets. 520.304 Carprofen. (3) Limitations. Federal law restricts 520.314 Cefadroxil. this drug to use by or on the order of a 520.370 Cefpodoxime tablets. licensed veterinarian. It is a violation 520.376 Cephalexin. of Federal law to use this product 520.390 Chloramphenicol oral dosage forms. other than as directed in the labeling. 520.390a Chloramphenicol tablets. 520.390b Chloramphenicol capsules. [82 FR 12169, Mar. 1, 2017] 520.390c Chloramphenicol palmitate oral suspension. 520.420 Chlorothiazide tablets and boluses. 520.434 Chlorphenesin carbamate tablets. PART 520—ORAL DOSAGE FORM 520.441 Chlortetracycline powder. NEW ANIMAL DRUGS 520.443 Chlortetracycline tablets and boluses. Sec. 520.445 Chlortetracycline and 520.23 Acepromazine. sulfamethazine powder. 520.28 Acetazolamide. 520.446 Clindamycin capsules and tablets. 520.38 Albendazole oral dosage forms. 520.447 Clindamycin solution. 520.38a Albendazole suspension. 520.452 Clenbuterol syrup. 520.38b Albendazole paste. 520.455 Clomipramine tablets. 520.43 Afoxolaner. 520.462 Clorsulon drench. 520.48 Altrenogest. 520.522 Cyclosporine. 520.62 Aminopentamide. 520.530 Cythioate oral liquid. 520.82 Aminopropazine oral dosage forms. 520.531 Cythioate tablets. 520.82a Aminopropazine. 520.534 Decoquinate. 520.82b Aminopropazine and neomycin. 520.538 Deracoxib. 520.88 Amoxicillin oral dosage forms. 520.540 Dexamethasone oral dosage forms. 520.88a Amoxicillin trihydrate film-coated 520.540a Dexamethasone powder. tablets. 520.540b Dexamethasone tablets and 520.88b Amoxicillin trihydrate for oral sus- boluses. pension. 520.540c Dexamethasone chewable tablets. 520.88c Amoxicillin trihydrate oral suspen- 520.563 Dexamethasone chewable tablets. sion. 520.580 Dichlorophene and toluene. 520.88d Amoxicillin trihydrate soluble pow- 520.581 Dichlorophene tablets. der. 520.600 Dichlorvos. 520.88e Amoxicillin trihydrate boluses. 520.606 Diclazuril. 520.88f Amoxicillin trihydrate tablets. 520.608 Dicloxacillin. 520.88g Amoxicillin trihydrate and 520.620 Diethylcarbamazine oral dosage clavulanate potassium tablets. forms. 520.88h Amoxicillin trihydrate and 520.622 Diethylcarbamazine citrate oral dos- clavulanate potassium for oral suspen- age forms. sion. 520.622a Diethylcarbamazine citrate tablets. 520.90 Ampicillin oral dosage forms. 520.622b Diethylcarbamazine citrate syrup. 520.90a [Reserved] 520.622c Diethylcarbamazine citrate chew- 520.90b Ampicillin tablets. able tablets. 520.90c Ampicillin capsules. 520.623 Diethylcarbamazine and 520.90d Ampicillin for oral suspension. oxibendazole chewable tablets. 520.90e Ampicillin for soluble powder. 520.645 Difloxacin. 520.90f Ampicillin boluses. 520.666 Dirlotapide. 520.100 Amprolium. 520.763 Dithiazanine oral dosage forms. 520.110 Apramycin sulfate soluble powder. 520.763a Dithiazanine tablets. 520.154 Bacitracin oral dosage forms. 520.763b Dithiazanine powder. 520.154a Bacitracin methylenedisalicylate. 520.763c Dithiazanine iodide and piperazine 520.154b Bacitracin methylenedisalicylate citrate suspension. and streptomycin sulfate powder. 520.766 Domperidone. 520.154c Bacitracin zinc soluble powder. 520.784 Doxylamine. 520.222 Bunamidine hydrochloride. 520.804 Enalapril. 520.246 Butorphanol tablets. 520.812 Enrofloxacin. 520.260 n-Butyl chloride. 520.816 Epsiprantel. 520.284 Cambendazole oral dosage forms. 520.823 Erythromycin. 520.284a Cambendazole suspension. 520.852 Estriol. 520.284b Cambendazole pellets. 520.863 Ethylisobutrazine. 520.284c Cambendazole paste. 520.870 Etodolac.

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520.903 Febantel oral dosage forms. 520.1265 Lincomycin and spectinomycin 520.903a Febantel paste. powder. 520.903b Febantel suspension. 520.1284 Liothyronine. 520.903c [Reserved] 520.1288 Lufenuron tablets. 520.903d Febantel and praziquantel paste. 520.1289 Lufenuron suspension. 520.903e Febantel tablets. 520.1310 Marbofloxacin. 520.905 Fenbendazole oral dosage forms. 520.1315 Maropitant. 520.905a Fenbendazole suspension. 520.1320 Mebendazole. 520.905b Fenbendazole granules. 520.1326 Mebendazole and trichlorfon oral 520.905c Fenbendazole paste. dosage forms. 520.905d Fenbendazole powder. 520.1326a Mebendazole and trichlorfon pow- 520.905e Fenbendazole blocks. der. 520.928 Firocoxib tablets. 520.1326b Mebendazole and trichlorfon paste. 520.930 Firocoxib paste. 520.1330 Meclofenamic acid granules. 520.955 Florfenicol. 520.1331 Meclofenamic acid tablets. 520.960 Flumethasone. 520.1341 Megestrol. 520.970 Flunixin. 520.1367 Meloxicam. 520.980 Fluoxetine. 520.1372 Methimazole. 520.998 Fluralaner. 520.1380 Methocarbamol. 520.1010 Furosemide. 520.1408 Methylprednisolone. 520.1409 Methylprednisolone and aspirin. 520.1044 Gentamicin sulfate oral dosage 520.1422 Metoserpate hydrochloride. forms. 520.1430 Mibolerone. 520.1044a Gentamicin sulfate oral solution. 520.1441 Milbemycin oxime. 520.1044b Gentamicin sulfate pig pump oral 520.1443 Milbemycin oxime and lufenuron. solution. 520.1445 Milbemycin oxime and 520.1044c Gentamicin sulfate powder. praziquantel. 520.1060 Glucose and glycine. 520.1447 Milbemycin oxime, lufenuron, and 520.1084 Grapiprant. praziquantel tablets. 520.1100 Griseofulvin. 520.1450 Morantel tartrate oral dosage 520.1120 Haloxon oral dosage forms. forms. 520.1120a Haloxon drench. 520.1450a Morantel tartrate bolus. 520.1120b Haloxon boluses. 520.1450b Morantel tartrate cartridge. 520.1130 Hetacillin. 520.1450c Morantel tartrate sustained-re- 520.1156 Imidacloprid. lease trilaminate cylinder/sheet. 520.1157 Iodinated casein. 520.1451 Moxidectin tablets. 520.1158 Iodochlorhydroxyquin. 520.1452 Moxidectin gel. 520.1182 Iron dextran suspension. 520.1453 Moxidectin and praziquantel gel. 520.1189 Itraconazole. 520.1454 Moxidectin solution. 520.1192 Ivermectin paste. 520.1468 Naproxen. 520.1193 Ivermectin tablets and chewables. 520.1484 Neomycin. 520.1194 Ivermectin meal. 520.1510 Nitenpyram. 520.1195 Ivermectin liquid. 520.1604 Oclacitinib. 520.1196 Ivermectin and pyrantel tablets. 520.1615 Omeprazole. 520.1197 Ivermectin sustained-release bolus. 520.1616 Orbifloxacin tablets.. 520.1198 Ivermectin and praziquantel paste. 520.1618 Orbifloxacin suspension. 520.1199 Ivermectin, pyrantel, and 520.1628 Oxfendazole powder and pellets. praziquantel tablets. 520.1629 Oxfendazole paste. 520.1200 Ivermectin, fenbendazole, and 520.1630 Oxfendazole suspension. praziquantel tablets. 520.1631 Oxfendazole and trichlorfon paste. 520.1204 Kanamycin, bismuth subcarbonate, 520.1638 Oxibendazole. activated attapulgite. 520.1660 Oxytetracycline. 520.1242 Levamisole. 520.1660a Oxytetracycline and carbomycin. 520.1242a Levamisole powder. 520.1660b Oxytetracycline hydrochloride 520.1242b Levamisole boluses or oblets. capsules. 520.1242c Levamisole and piperazine. 520.1660c Oxytetracycline hydrochloride 520.1242d Levamisole resinate. tablets/boluses. 520.1242e Levamisole hydrochloride effer- 520.1660d Oxytetracycline powder. vescent tablets. 520.1696 Penicillin. 520.1242f Levamisole gel. 520.1696a [Reserved] 520.1242g Levamisole resinate and famphur 520.1696b Penicillin G powder. paste. 520.1696c Penicillin V powder. 520.1248 Levothyroxine. 520.1696d Penicillin V tablets. 520.1263 Lincomycin. 520.1705 Pergolide. 520.1263a Lincomycin tablets and syrup. 520.1720 Phenylbutazone oral dosage forms. 520.1263b [Reserved] 520.1720a Phenylbutazone tablets and 520.1263c Lincomycin powder. boluses.

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520.1720b Phenylbutazone granules. 520.2220d Sulfadimethoxine bolus. 520.1720c Phenylbutazone paste. 520.2220e Sulfadimethoxine extended-release 520.1720d Phenylbutazone gel. bolus. 520.1720e Phenylbutazone powder. 520.2220f Sulfadimethoxine and ormetoprim 520.1760 Phenylpropanolamine. tablet. 520.1780 Pimobendan. 520.2240 Sulfaethoxypyridazine. 520.1802 Piperazine-carbon disulfide complex 520.2240a Sulfaethoxypyridazine solution. oral dosage forms. 520.2240b Sulfaethoxypyridazine tablets. 520.1802a Piperazine-carbon disulfide com- 520.2260 Sulfamethazine oral dosage forms. plex suspension. 520.2260a Sulfamethazine oblet, tablet, and 520.1802b Piperazine-carbon disulfide com- bolus. plex boluses. 520.2260b Sulfamethazine sustained-release 520.1802c Piperazine-carbon disulfide com- boluses. plex with phenothiazine suspension. 520.2260c Sulfamethazine sustained-release 520.1803 Piperazine citrate capsules. tablets. 520.1804 Piperazine phosphate capsules. 520.2261 Sulfamethazine sodium oral dosage 520.1805 Piperazine phosphate with thenium forms. closylate tablets. 520.2261a Sulfamethazine solution. 520.1806 Piperazine suspension. 520.2261b Sulfamethazine powder. 520.1807 Piperazine. 520.2280 Sulfamethizole and methenamine. 520.1840 Poloxalene. 520.2325 Sulfaquinoxaline oral dosage forms. 520.1846 Polyoxyethylene (23) lauryl ether 520.2325a Sulfaquinoxaline powder and solu- blocks. tion. 520.1855 Ponazuril. 520.2325b Sulfaquinoxaline drench. 520.1860 Pradofloxacin. 520.2330 Sulfisoxazole tablets. 520.1870 Praziquantel tablets. 520.2340 Tepoxalin. 520.1871 Praziquantel and pyrantel. 520.2345 Tetracycline. 520.1872 Praziquantel, pyrantel pamoate, 520.2345a Tetracycline capsules. and febantel tablets. 520.2345b Tetracycline tablets. 520.1880 Prednisolone. 520.2345c Tetracycline boluses. 520.1900 Primidone. 520.2345d Tetracycline powder. 520.1920 Prochlorperazine and isopropamide. 520.2345e Tetracycline solution. 520.1921 Prochlorperazine, isopropamide, 520.2345f Tetracycline phosphate complex and neomycin. and sodium novobiocin capsules. 520.1962 Promazine. 520.2345g Tetracycline hydrochloride and so- 520.2002 Propiopromazine. dium novobiocin tablets. 520.2041 Pyrantel pamoate chewable tablets. 520.2345h Tetracycline hydrochloride, so- 520.2042 Pyrantel pamoate tablets. dium novobiocin, and prednisolone tab- 520.2043 Pyrantel pamoate suspension. lets. 520.2044 Pyrantel pamoate paste. 520.2362 Thenium closylate. 520.2045 Pyrantel tartrate powder. 520.2380 Thiabendazole oral dosage forms. 520.2046 Pyrantel tartrate pellets. 520.2380a Thiabendazole top dressing and 520.2075 Robenacoxib. mineral protein block. 520.2086 Sarolaner. 520.2380b Thiabendazole drench or paste. 520.2098 Selegiline. 520.2380c Thiabendazole bolus. 520.2100 Selenium and vitamin E. 520.2380d Thiabendazole and piperazine cit- 520.2123 Spectinomycin oral dosage forms. rate. 520.2123a Spectinomycin tablets. 520.2380e Thiabendazole and trichlorfon. 520.2123b Spectinomycin powder. 520.2380f Thiabendazole and piperazine phos- 520.2123c Spectinomycin solution. phate. 520.2130 Spinosad. 520.2455 Tiamulin. 520.2134 Spinosad and milbemycin. 520.2471 Tilmicosin. 520.2150 Stanozolol. 520.2473 Tioxidazole oral dosage forms. 520.2158 Streptomycin. 520.2473a Tioxidazole granules. 520.2170 Sulfabromomethazine. 520.2473b Tioxidazole paste. 520.2184 Sulfachloropyrazine. 520.2475 Toceranib. 520.2200 Sulfachlorpyridazine. 520.2481 Triamcinolone acetonide tablets. 520.2215 Sulfadiazine/pyrimethamine sus- 520.2482 Triamcinolone acetonide oral pow- pension. der. 520.2218 Sulfamerazine, sulfamethazine, and 520.2483 Triamcinolone. sulfaquinoxaline powder. 520.2520 Trichlorfon oral dosage forms. 520.2220 Sulfadimethoxine oral dosage 520.2520a Trichlorfon and atropine. forms. 520.2520b Trichlorofon boluses. 520.2220a Sulfadimethoxine oral solution 520.2520c Trichlorofon granules. and soluble powder. 520.2520d Trichlorfon, phenothiazine, and pi- 520.2220b Sulfadimethoxine suspension. perazine dihydrochloride powder. 520.2220c Sulfadimethoxine tablet. 520.2582 Triflupromazine.

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520.2598 Trilostane. (3) Limitations. Federal law restricts 520.2604 Trimeprazine and prednisolone tab- this drug to use by or on the order of a lets. licensed veterinarian. 520.2605 Trimeprazine and prednisolone capsules. [79 FR 28816, May 20, 2014] 520.2610 Trimethoprim and sulfadiazine tablets. § 520.38 Albendazole oral dosage 520.2611 Trimethoprim and sulfadiazine forms. paste. 520.2612 Trimethoprim and sulfadiazine sus- § 520.38a Albendazole suspension. pension. (a) Specifications. Each milliliter of 520.2613 Trimethoprim and sulfadiazine suspension contains 45.5 milligrams powder. 520.2640 Tylosin. (mg) (4.55 percent) or 113.6 mg (11.36 520.2645 Tylvalosin. percent) albendazole. (b) Sponsor. See No. 054771 in § 510.600 AUTHORITY: 21 U.S.C. 360b. of this chapter. SOURCE: 40 FR 13838, Mar. 27, 1975, unless (c) Related tolerances. See § 556.34 of otherwise noted. this chapter. (d) Special considerations. See § 500.25 § 520.23 Acepromazine. of this chapter. (a) Specifications. Each tablet con- (e) Conditions of use—(1) Cattle. Ad- tains 5, 10, or 25 milligrams (mg) minister 11.36 percent suspension: acepromazine maleate. (i) Amount. 4.54 mg/pound (lb) body (b) Sponsors. See No. 000010 in weight (10 mg/kilogram (kg)) as a sin- § 510.600(c) of this chapter. gle oral dose using dosing gun or dos- (c) Conditions of use—(1) Dogs—(i) ing syringe. Amount. 0.25 to 1.0 mg per pound (/lb) (ii) Indications for use. For removal body weight orally. and control of adult liver flukes (ii) Indications for use. As an aid in (Fasciola hepatica); heads and segments tranquilization and as a preanesthetic of tapeworms (Moniezia benedeni and M. agent. expansa); adult and 4th stage larvae of (iii) Limitations. Federal law restricts stomach worms (brown stomach worms this drug to use by or on the order of a including 4th stage inhibited larvae licensed veterinarian. (Ostertagia ostertagi), barberpole worm (2) Cats—(i) Amount. 0.5 to 1.0 mg/lb (Haemonchus contortus and H. placei), body weight orally. small stomach worm (Trichostrongylus (ii) Indications for use. As a tranquil- axei)); adult and 4th stage larvae of in- izer. testinal worms (thread-necked intes- (iii) Limitations. Federal law restricts tinal worm (Nematodirus spathiger and this drug to use by or on the order of a N. helvetianus), small intestinal worm licensed veterinarian. (Cooperia punctata and C. oncophora)); adult stages of intestinal worms [75 FR 10165, Mar. 5, 2010] (hookworm (Bunostomum phlebotomum), bankrupt worm (Trichostrongylus § 520.28 Acetazolamide. colubriformis), nodular worm (a) Specifications. A powder con- (Oesophagostomum radiatum)); adult and taining acetazolamide sodium, USP 4th stage larvae of lungworms equivalent to 25 percent acetazolamide (Dictyocaulus viviparus). activity. (iii) Limitations. Do not slaughter (b) Sponsor. See No. 054771 in within 27 days of last treatment. Do § 510.600(c) of this chapter. not use in female dairy cattle of breed- (c) Conditions of use in dogs—(1) ing age: Do not administer to female Amount. Administer orally at a dosage cattle during first 45 days of pregnancy of 5 to 15 milligrams per pound of body or for 45 days after removal of bulls. weight daily. (2) Sheep. Administer 4.45 or 11.36 per- (2) Indications for use. As an aid in the cent suspension: treatment of mild congestive heart (i) Amount. 3.4 mg/lb body weight (7.5 failure and for rapid reduction of intra- mg/kg) as a single oral dose using dos- ocular pressure. ing gun or dosing syringe.

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(ii) Indications for use. For removal of tapeworms (Moniezia benedeni, M. and control of adult liver flukes expansa); adult and 4th stage larvae of (Fasciola hepatica and Fascioloides stomach worms (brown stomach worms magna); heads and segments of common including 4th stage inhibited larvae tapeworms (Moniezia expansa) and (Ostertagia ostertagi); barberpole worm fringed tapeworm (Thysanosoma (Haemonchus contortus, H. placei); small actinioides); adult and fourth stage lar- stomach worm (Trichostrongylus axei)); vae of stomach worms (brown stomach adult and 4th stages larvae of intes- worm (Ostertagia circumcinta and tinal worms (thread-necked intestinal Marshallagia marshalli), barberpole worm (Nematodirus spathiger, N. worm (Haemonchus contortus), small helvetianus); small intestinal worm stomach worm (Trichostrongylus axei)); ( and )); adult and fourth stage larvae of intes- Cooperia punctata C. oncophora tinal worms (thread-necked intestinal adult stages of intestinal worms worm (Nematodirus spathiger and N. (hookworm (Bunostomum phlebotmum); filicollis), Cooper’s worm (Cooperia bankrupt worm (Trichostrongylus oncophora), bankrupt worm colubriformis), nodular worm (Trichostrongylus colubriformis), nodular (Oesophagostomum radiatum)); adult and worm (Oesophagostomum columbianum), 4th stage larvae of lungworms and large-mouth bowel worm (Chabertia (Dictyocaulus viviparus). ovina)); adult and larval stages of (3) Limitations. Administer as a single lungworms (Dictyocaulus filaria). oral dose. Do not slaughter within 27 (iii) Limitations. Do not slaughter days of last treatment. Do not use in within 7 days of last treatment. Do not female dairy cattle of breeding age. Do administer to ewes during first 30 days not administer to female cattle during of pregnancy or for 30 days after re- first 45 days of pregnancy or for 45 days moval of rams. after removal of bulls. Consult your (3) Goats. Administer 11.36 percent veterinarian for assistance in the diag- suspension: nosis, treatment, and control of para- (i) Amount. 4.54 mg/lb body weight (10 sitism. mg/kg) as a single oral dose using dosing gun or dosing syringe. [54 FR 51385, Dec. 15, 1989, as amended at 56 (ii) Indications for use. For the treat- FR 50653, Oct. 8, 1991; 60 FR 55658, Nov. 2, ment of adult liver flukes (Fasciola he- 1995. Redesignated at 78 FR 66264, Nov. 5, patica) in nonlactating goats. 2013, as amended at 79 FR 28816, May 20, 2014] (iii) Limitations. Do not slaughter within 7 days of last treatment. Do not § 520.43 Afoxolaner. administer to does during the first 30 (a) Specifications. Each chewable tab- days of pregnancy or for 30 days after let contains 11.3, 28.3, 68, or 136 milli- removal of bucks. grams (mg) afoxolaner. [73 FR 11027, Feb. 29, 2008. Redesignated at 78 (b) Sponsor. See No. 050604 in FR 66264, Nov. 5, 2013, as amended at 79 FR § 510.600(c) of this chapter. 28816, May 20, 2014] (c) Conditions of use—(1) Amount. Ad- minister orally once a month at a min- § 520.38b Albendazole paste. imum dosage of 1.14 mg/pound (lb) (2.5 (a) Specifications. The product con- mg/kilogram (kg)). tains 30 percent albendazole. (2) Indications for use. Kills adult (b) Sponsor. See No. 054771 in fleas; for the treatment and prevention § 510.600(c) of this chapter. of flea infestations (Ctenocephalides (c) Related tolerances. See § 556.34 of felis); for the treatment and control of this chapter. (d) Conditions of use in cattle—(1) black-legged tick (Ixodes scapularis), Amount. Equivalent to 4.54 milligrams American dog tick (Dermacentor per 1 pound of body weight (10 milli- variabilis), lone star tick (Amblyomma grams per kilogram). americanum), and brown dog tick (2) Indications for use. For removal (Rhipicephalus sanguineus) infestations and control of the following internal in dogs and puppies 8 weeks of age and parasites of cattle: adult liver flukes older, weighing 4 lb of body weight or (Fasciola hepatica); heads and segments greater, for 1 month.

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(3) Limitations. Federal law restricts 0.3 mg; for animals weighing 51 to 100 this drug to use by or on the order of a lbs: 0.4 mg; for animal weighing over licensed veterinarian. 100 lbs: 0.5 mg. Dosage may be gradu- [78 FR 66264, Nov. 5, 2013, as amended at 79 ally increased up to a maximum of five FR 37619, July 2, 2014; 80 FR 18775, Apr. 8, times the suggested dosage. Oral ad- 2015] ministration of tablets may be preceded by subcutaneous or § 520.48 Altrenogest. intramuscular use of the injectable (a) Specifications. Each milliliter form of the drug. (mL) of solution contains 2.2 milli- (2) Indications for use. For the treat- grams (mg) altrenogest. ment of vomiting and/or diarrhea, nau- (b) Sponsors. See Nos. 000061, 051072, sea, acute abdominal visceral spasm, and 061623 in § 510.600(c) of this chapter. pylorospasm, or hypertrophic gastritis. (c) Tolerances. See § 556.36 of this (3) Limitations. Federal law restricts chapter. this drug to use by or on the order of a (d) Conditions of use—(1) Horses—(i) licensed veterinarian. Amount. 1.0 mL per 110 pounds body [79 FR 28816, May 20, 2014] weight (0.044 mg/kg) daily for 15 consecutive days. § 520.82 Aminopropazine oral dosage (ii) Indications for use. For suppres- forms. sion of estrus in mares. (iii) Limitations. Do not use in horses § 520.82a Aminopropazine. intended for human consumption. Fed- (a) Specifications. Each tablet con- eral law restricts this drug to use by or tains aminopropazine fumarate equiva- on the order of a licensed veterinarian. lent to 25 percent aminopropazine base. (2) Swine—(i) Amount. Administer 6.8 (b) Sponsor. See No. 000061 in mL (15 mg altrenogest) per gilt once § 510.600(c) of this chapter. daily for 14 consecutive days by top- (c) Conditions of use in dogs and cats— dressing on a portion of each gilt’s (1) Amount. Administer orally at a dos- daily feed. age of 1 to 2 milligrams per pound of (ii) Indications for use. For synchroni- body weight, repeated every 12 hours as zation of estrus in sexually mature indicated. gilts that have had at least one estrous (2) Indications for use. For reducing cycle. excessive smooth muscle contractions, (iii) Limitations. Do not use in gilts such as occur in urethral spasms asso- having a previous or current history of ciated with urolithiasis. uterine inflammation (i.e., acute, (3) Limitations. Federal law restricts subacute or chronic endometritis). this drug to use by or on the order of a Gilts must not be slaughtered for licensed veterinarian. human consumption for 21 days after the last treatment. [79 FR 28816, May 20, 2014] [66 FR 47960, Sept. 17, 2001, as amended at 68 § 520.82b Aminopropazine and neomy- FR 62006, Oct. 31, 2003; 72 FR 9455, Feb. 21, cin. 2008; 74 FR 61516, Nov. 25, 2009; 77 FR 32012, May 31, 2012; 80 FR 34278, June 16, 2015; 82 FR (a) Specifications. Each tablet con- 21690, May 10, 2017; 83 FR 13635, Mar. 30, 2018] tains aminopropazine fumarate equivalent to 25 percent aminopropazine base § 520.62 Aminopentamide. and neomycin sulfate equivalent to 50 (a) Specifications. Each tablet con- milligrams (mg) of neomycin base. tains 0.2 milligram (mg) (b) Sponsor. See No. 000061 in aminopentamide hydrogen sulphate. § 510.600(c) of this chapter. (b) Sponsor. See No. 054771 in (c) Conditions of use in dogs—(1) § 510.600(c) of this chapter. Amount. Administer orally at a dosage (c) Conditions of use in dogs and cats— of 1 to 2 mg per pound of body weight, (1) Amount. Administer orally every 8 repeated every 12 hours as indicated. to 12 hours as follows: For animals (2) Indications for use. For control of weighing up to 10 pounds (lbs): 0.1 mg; bacterial diarrhea caused by organisms for animals weighing 11 to 20 lbs: 0.2 susceptible to neomycin and to reduce mg; for animals weighing 21 to 50 lbs: smooth muscle contractions.

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(3) Limitations. Federal law restricts § 520.88b Amoxicillin trihydrate for this drug to use by or on the order of a oral suspension. licensed veterinarian. (a) Specifications. When reconstituted, [79 FR 28816, May 20, 2014] each milliliter contains amoxicillin trihydrate equivalent to 50 milligrams § 520.88 Amoxicillin oral dosage forms. (mg) amoxicillin. (b) Sponsor. See No. 054771 in § 520.88a Amoxicillin trihydrate film- § 510.600(c) of this chapter. coated tablets. (1) Conditions of use—(i) Dogs—(A) (a) Specifications. Each tablet con- Amount. Administer orally 5 mg per tains amoxicillin trihydrate equivalent pound (/lb) of body weight, twice a day to 50, 100, 150, 200, or 400 milligrams for 5 to 7 days. (mg) amoxicillin. (B) Indications for use. Treatment of (b) Sponsor. See No. 054771 in infections caused by susceptible strains § 510.600(c) of this chapter. of organisms as follows: respiratory tract (tonsillitis, tracheobronchitis) (c) Conditions of use—(1) Dogs—(i) caused by Staphylococcus aureus, Strep- Amount. Administer orally 5 mg per tococcus spp., Escherichia coli, and Pro- pound (/lb) of body weight, twice a day teus mirabilis; genitourinary tract (cys- for 5 to 7 days. titis) caused by S. aureus, Streptococcus (ii) Indications for use. Treatment of spp., E. coli, and P. mirabilis; gastro- infections of the respiratory tract (ton- intestinal tract (bacterial sillitis, tracheobronchitis), genito- gastroenteritis) caused by S. aureus, urinary tract (cystitis), gastro- Streptococcus spp., E. coli, and P. intestinal tract (bacterial mirabilis; bacterial dermatitis caused gastroenteritis), and soft tissues (ab- by S. aureus, Streptococcus spp., and P. scesses, lacerations, wounds), caused mirabilis; and soft tissues (abscesses, by susceptible strains of Staphylococcus lacerations, and wounds) caused by S. aureus, Streptococcus spp., Escherichia aureus, Streptococcus spp., E. coli, and P. coli, Proteus mirabilis, and bacterial der- mirabilis. matitis caused by S. aureus, Strepto- (C) Limitations. Federal law restricts coccus spp., and P. mirabilis. this drug to use by or on the order of a (iii) Limitations. Federal law restricts licensed veterinarian. this drug to use by or on the order of a (ii) Cats—(A) Amount. Administer licensed veterinarian. orally 5 to 10 mg/lb of body weight, (2) Cats—(i) Amount. Administer oral- once daily for 5 to 7 days. ly 5 to 10 mg/lb of body weight, once (B) Indications for use. Treatment of daily for 5 to 7 days. infections caused by susceptible strains (ii) Indications for use. Treatment of of organisms as follows: upper respiratory tract due to Staphylococcus infections caused by susceptible orga- spp., Streptococcus spp., Haemophilus nisms as follows: upper respiratory spp., E. coli, Pasteurella spp., and P. tract due to S. aureus, Streptococcus mirabilis; genitourinary tract (cystitis) spp., and E. coli; genitourinary tract due to S. aureus, Streptococcus spp., E. (cystitis) due to S. aureus, Streptococcus coli, P. mirabilis, and Corynebacterium spp., E. coli, and P. mirabilis; gastro- spp.; gastrointestinal tract due to E. intestinal tract due to E. coli; and skin coli, Proteus spp., Staphylococcus spp., and soft tissue (abscesses, lacerations, and Streptococcus spp.; skin and soft tis- and wounds) due to S. aureus, Strepto- sue (abscesses, lacerations, and coccus spp., E. coli, and Pasteurella wounds) due to Staphylococcus spp., multocida. Streptococcus spp., E. coli, and (iii) Limitations. Federal law restricts Pasteurella multocida. this drug to use by or on the order of a (C) Limitations. Federal law restricts licensed veterinarian. this drug to use by or on the order of a licensed veterinarian. [57 FR 37319, Aug. 18, 1992, as amended at 60 (2) [Reserved] FR 55658, Nov. 2, 1995; 79 FR 28816, May 20, 2014] (c) Sponsors. See Nos. 000856 and 051311 in § 510.600(c) of this chapter.

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(1) Conditions of use. Dogs—(i) Amount. (d) Conditions of use in preruminating Administer orally 5 mg/lb of body calves including veal calves—(1) Amount. weight, twice a day for 5 to 7 days. Administer 400 mg per 100 pounds of (ii) Indications for use. Treatment of body weight twice daily by drench or in bacterial dermatitis due to S. aureus, milk. Treatment should be continued Streptococcus spp., Staphylococcus spp., for 48 hours after all symptoms have and E. coli, and soft tissue infections subsided but not to exceed 5 days. (abscesses, wounds, lacerations) due to (2) Indications for use. Treatment of S. aureus, Streptococcus spp., E. coli, P. bacterial enteritis when due to suscep- mirabilis and Staphylococcus spp. tible Escherichia coli in preruminating (iii) Limitations. Federal law restricts calves including veal calves. this drug to use by or on the order of a (3) Limitations. Do not slaughter ani- licensed veterinarian. mals during treatment or for 20 days (2) [Reserved] after the latest treatment. Federal law restricts this drug to use by or on the [57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 60 FR 55658, Nov. 2, order of a licensed veterinarian 1995; 62 FR 13302, Mar. 20, 1997; 67 FR 67521, [57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. Nov. 6, 2002; 68 FR 54658, Sept. 18, 2003; 68 FR 15, 1992; 58 FR 18304, Apr. 8, 1993, as amended 55824, Sept. 29, 2003; 79 FR 28816, May 20, 2014; at 60 FR 55658, Nov. 2, 1995; 62 FR 5525, Feb. 81 FR 17607, Mar. 30, 2016] 6, 1997; 79 FR 28817, May 20, 2014]

§ 520.88c Amoxicillin trihydrate oral § 520.88e Amoxicillin trihydrate suspension. boluses. (a) Specifications. Each 0.8-milliliter (a) Specifications. Each bolus contains dose contains amoxicillin trihydrate amoxicillin trihydrate equivalent to equivalent to 40 milligrams (mg) 400 milligrams (mg) amoxicillin. amoxicillin. (b) Sponsor. See No. 054771 in (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Related tolerances. See § 556.38 of (c) Related tolerances. See § 556.510 of this chapter. this chapter. (d) Conditions of use in cattle—(1) (d) Conditions of use in swine—(1) Amount. Administer 400 mg per 100 Amount. Administer 40 mg orally twice pounds of body weight twice daily. a day using a dosing pump. Treat ani- Treatment should be continued for 48 mals for 48 hours after all symptoms hours after all symptoms have subsided have subsided but not beyond 5 days. but not to exceed 5 days. (2) Indications for use. Treatment of (2) Indications for use. Treatment of baby pigs under 10 pounds for porcine bacterial enteritis when due to suscep- colibacillosis caused by Escherichia coli tible Escherichia coli in preruminating susceptible to amoxicillin. calves including veal calves. (3) Limitations. Do not slaughter dur- (3) Limitations. Do not slaughter ani- ing treatment or for 15 days after lat- mals during treatment or for 20 days est treatment. Federal law restricts after the latest treatment. Federal law this drug to use by or on the order of a restricts this drug to use by or on the licensed veterinarian. order of a licensed veterinarian. [57 FR 37319, Aug. 18, 1992, as amended at 60 [57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995; 79 FR 28817, May 20, FR 55659, Nov. 2, 1995; 62 FR 5526, Feb. 6, 1997; 2014] 79 FR 28817, May 20, 2014]

§ 520.88d Amoxicillin trihydrate solu- § 520.88f Amoxicillin trihydrate tab- ble powder. lets. (a) Specifications. Each gram of pow- (a) Specifications. Each tablet con- der contains amoxicillin trihydrate tains amoxicillin trihydrate equivalent equivalent to 115.4 milligrams (mg) to 50, 100, 200, or 400 milligrams (mg) amoxicillin. amoxicillin. (b) Sponsor. See No. 054771 in (b) Sponsors. See Nos. 051311 and § 510.600(c) of this chapter. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.38 of (c) Conditions of use in dogs—(1) this chapter. Amount. Administer 5 mg per pound of

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body weight twice daily for 5 to 7 days (2) Cats—(i) Amount. 62.5 milligrams or 48 hours after all symptoms have (50 milligrams amoxicillin and 12.5 mil- subsided. ligrams clavulanic acid) twice daily for (2) Indications for use. For treatment 5 to 7 days or for 48 hours after all of bacterial dermatitis due to Staphy- signs have subsided. Urinary tract in- lococcus aureus, Streptococcus spp., fections may require treatment for 10 Staphylococcus spp., and Escherichia to 14 days or longer. The maximum du- coli; and soft tissue infections (ab- ration of treatment should not exceed scesses, wounds, lacerations) due to S. 30 days. aureus, Streptococcus spp., E. coli, Pro- (ii) Indications for use. Treatment of teus mirabilis, and Staphylococcus spp. skin and soft tissue infections, such as (3) Limitations. Federal law restricts wounds, abscesses and cellulitis/derma- this drug to use by or on the order of a titis due to susceptible strains of beta- licensed veterinarian. lactamase (penicillinase) producing S. [79 FR 28817, May 20, 2014] aureus, non-beta-lactamase producing S. aureus, Staphylococcus spp., Strepto- § 520.88g Amoxicillin trihydrate and coccus spp., E. coli, and Pasteurella spp. clavulanate potassium tablets. Also, treatment of urinary tract infections (cystitis) due to susceptible (a) Specifications. Each tablet or chewable tablet contains amoxicillin strains of E. coli. trihydrate and clavulanate potassium (iii) Limitations. Federal law restricts equivalent to 50 milligrams (mg) of this drug to use by or on the order of a amoxicillin and 12.5 mg clavulanic licensed veterinarian. acid, 100 mg of amoxicillin and 25 mg [57 FR 37320, Aug. 18, 1992, as amended at 60 clavulanic acid, 200 mg amoxicillin and FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, 50 mg clavulanic acid, or 300 mg 1998; 79 FR 28817, May 20, 2014; 80 FR 34278, amoxicillin and 75 mg clavulanic acid. June 16, 2015; 82 FR 11508, Feb. 24, 2017; 82 FR (b) Sponsors. See sponsors in 43484, Sept. 18, 2017; 82 FR 58556, Dec. 13, 2017] § 510.600(c) of this chapter: (1) No. 054771 for use of tablets and § 520.88h Amoxicillin trihydrate and clavulanate potassium for oral sus- chewable tablets as in paragraph (c) of pension. this section. (2) No. 026637 for use of tablets as in (a) Specifications. When reconstituted, paragraph (c) of this section. each milliliter contains amoxicillin (c) Conditions of use—(1) Dogs—(i) trihydrate equivalent to 50 milligrams Amount. 6.25 milligrams (equivalent to of amoxicillin with clavulanate potas- 5 milligrams amoxicillin and 1.25 milli- sium equivalent to 12.5 milligrams of grams clavulanic acid) per pound of clavulanic acid. body weight twice daily for 5 to 7 days (b) Sponsor. See No. 054771 in or for 48 hours after all signs have sub- § 510.600(c) of this chapter. sided. Deep pyoderma may require (c) Conditions of use—(1) Dogs—(i) treatment for 21 days; do not treat for Amount. 6.25 milligrams (equivalent to more than 30 days. 5 milligrams amoxicillin and 1.25 milli- (ii) Indications for use. Treatment of grams clavulanic acid) per pound of skin and soft tissue infections such as body weight twice daily for 5 to 7 days wounds, abscesses, cellulitis, super- or for 48 hours after all signs have sub- ficial/juvenile and deep pyoderma due sided. Deep pyoderma may require to susceptible strains of beta- treatment for 21 days; do not treat for lactamase (penicillinase) Staphy- more than 30 days. lococcus aureus, non-beta-lactamase S. (ii) Indications for use. Treatment of aureus, Staphylococcus spp., Strepto- skin and soft tissue infections such as coccus spp., and Escherichia coli. Treat- wounds, abscesses, cellulitis, super- ment of periodontal infections due to ficial/juvenile and deep pyoderma due susceptible strains of aerobic and an- to susceptible strains of beta- aerobic bacteria. lactamase (penicillinase) producing (iii) Limitations. Federal law restricts Staphylococcus aureus, nonbeta- this drug to use by or on the order of a lactamase Staphylococcus aureus, Staph- licensed veterinarian. ylococcus spp., Streptococcus spp., and

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Escherichia coli. Treatment of peri- intestinal infections due to Staphy- odontal infections due to susceptible lococcus spp., Streptococcus spp., strains of aerobic and anaerobic bac- Enterococcus spp., and E. coli. ; infec- teria. tions associated with abscesses, lacera- (iii) Limitations. Federal law restricts tions, and wounds caused by Staphy- this drug to use by or on the order of a lococcus spp., and Streptococcus spp. licensed veterinarian. (3) Limitations. Federal law restricts (2) Cats—(i) Amount. 62.5 milligrams this drug to use by or on the order of a (1 milliliter) (50 milligrams amoxicillin licensed veterinarian. and 12.5 milligrams clavulanic acid) twice daily. Administer 48 hours after [57 FR 37321, Aug. 18, 1992, as amended at 60 all signs have subsided. Maximum du- FR 55659, Nov. 2, 1995; 79 FR 28818, May 20, ration of treatment should not exceed 2014] 30 days. (ii) Indications for use. Treatment of § 520.90c Ampicillin capsules. feline skin and soft tissue infections, (a) Specifications. Each capsule con- such as wounds, abscesses and tains ampicillin trihydrate equivalent cellulitis/dermatitis due to susceptible to 125, 250, or 500 milligrams of ampi- strains of beta-lactamase (penicil- cillin. linase) producing S. aureus, nonbeta- (b) Sponsor. See No. 054771 in lactamase S. aureus, Staphylococcus § 510.600(c) of this chapter. spp., Streptococcus spp., E. coli, (c) Conditions of use—(1) Dogs—(i) Pasteurella multocida, and Pasteurella Amount. 5 to 10 milligrams per pound of spp. body weight two or three times daily. (iii) Limitations. Federal law restricts In severe or acute conditions, 10 milli- this drug to use by or on the order of a licensed veterinarian. grams per pound of body weight, three times daily. Administer 1 to 2 hours [57 FR 37320, Aug. 18, 1992, as amended at 60 prior to feeding. FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, (ii) Indications for use. Treatment 1998; 79 FR 28817, May 20, 2014] against strains of gram-negative and § 520.90 Ampicillin oral dosage forms. gram-positive organisms sensitive to ampicillin and associated with res- § 520.90a [Reserved] piratory tract infections (tracheobronchitis and tonsillitis); uri- § 520.90b Ampicillin tablets. nary tract infections (cystitis); bac- (a) Specifications. Each tablet con- terial gastroenteritis; generalized in- tains ampicillin trihydrate equivalent fections (septicemia) associated with to 50 or 100 milligrams of ampicillin. abscesses, lacerations, and wounds; and (b) Sponsor. See No. 054771 in bacterial dermatitis. § 510.600(c) of this chapter. (iii) Limitations. Federal law restricts (c) Conditions of use in dogs—(1) this drug to use by or on the order of a Amount. 5 milligrams per pound of body licensed veterinarian. weight, at 8-hour intervals, 1 to 2 hours (2) Cats—(i) Amount. 10 to 30 milli- prior to feeding, to be continued 36 to grams per pound of body weight or 48 hours after all symptoms have subsided. If no improvement is seen within three times daily. Administer 1 to 2 5 days, stop treatment, reevaluate di- hours prior to feeding. agnosis, and change therapy. (ii) Indications for use. Treatment (2) Indications for use. Oral treatment against strains of gram-negative and of infections caused by susceptible or- gram-positive organisms sensitive to ganisms as follows: Upper respiratory ampicillin and associated with res- infections, tonsillitis, and bronchitis piratory tract infections (bacterial due to Streptococcus spp., Staphylococcus pneumonia); urinary tract infections spp., Escherichia coli, Proteus mirabilis, (cystitis); and generalized infections and Pasteurella spp., urinary tract in- (septicemia) associated with abscesses, fections (cystitis) due to Streptococcus lacerations, and wounds. spp., Staphylococcus spp., E., coli, P. mirabilis, and Enterococcus spp.; gastro-

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(iii) Limitations. Federal law restricts due to E. coli, Staphylococcus spp., this drug to use by or on the order of a Streptococcus spp., Proteus spp., and licensed veterinarian. Corynebacterium spp.; generalized infec- [57 FR 37321, Aug. 18, 1992, as amended at 58 tions (septicemia) associated with ab- FR 61016, Nov. 19, 1993; 79 FR 28818, May 20, scesses, lacerations, and wounds, due 2014] to Staphylococcus spp., Streptococcus spp., Bacillus spp., and Pasteurella spp. § 520.90d Ampicillin for oral suspen- (iii) Limitations. Federal law restricts sion. this drug to use by or on the order of a (a) Specifications. When reconstituted licensed veterinarian. as directed, each milliliter contains [57 FR 37321, Aug. 18, 1992, as amended at 58 ampicillin trihydrate equivalent to 25 FR 61016, Nov. 19, 1993; 79 FR 28818, May 20, milligrams of ampicillin. 2014] (b) Sponsor. See No. 055529 in § 510.600(c) of this chapter. § 520.90e Ampicillin for soluble pow- (c) Conditions of use—(1) Dogs—(i) der. Amount. Administer to 10 milligrams (a) Specifications. Each gram contains per pound of body weight orally, 2 or 3 ampicillin trihydrate equivalent to 88.2 times daily, 1 to 2 hours prior to feed- milligrams of ampicillin. ing. In severe or acute conditions, 10 (b) Sponsor. See No. 055529 in milligrams per pound of body weight 3 § 510.600(c) of this chapter. times daily. Duration of treatment is (c) Related tolerances. See § 556.40 of usually 3 to 5 days. Continue treatment this chapter. 48 hours after the animal’s tempera- (d) Conditions of use. Swine—(1) ture has returned to normal and all Amount. 5 milligrams of ampicillin per other signs of infection have subsided. pound of body weight twice daily, oral- (ii) Indications for use. Treatment of ly by gavage or in drinking water for respiratory tract infections up to 5 days. (tracheobronchitis and tonsillitis) due (2) Indications for use. Oral treatment to Escherichia coli, Pseudomonas spp., of porcine colibacillosis (Escherichia Proteus spp., Staphylococcus spp., and coli) and salmonellosis (Salmonella spp.) Streptococcus spp., urinary tract infec- infections in swine up to 75 pounds of tions (cystitis) due to E. coli, Staphy- body weight, and bacterial pneumonia lococcus spp., Streptococcus spp., and caused by Pasteurella multocida, Staphy- Proteus spp.; bacterial gastroenteritis lococcus spp., Streptococcus spp., and due to E. coli; generalized infections Salmonella spp. (septicemia) associated with abscesses, (3) Limitations. Treated swine must lacerations, and wounds, due to Staphy- not be slaughtered for food during lococcus spp. and Streptococcus spp.; bac- treatment and for 24 hours following terial dermatitis due to Staphylococcus the last treatment. Federal law re- spp., Streptococcus spp., Proteus spp., stricts this drug to use by or on the and Pseudomonas spp. order of a licensed veterinarian. (iii) Limitations. Federal law restricts this drug to use by or on the order of a [57 FR 37322, Aug. 18, 1992, as amended at 58 licensed veterinarian. FR 61016, Nov. 19, 1993; 79 FR 28818, May 20, (2) Cats—(i) Amount. Administer 10 to 2014] 30 milligrams per pound of body weight orally, 2 or 3 times daily, 1 to 2 hours § 520.90f Ampicillin boluses. prior to feeding. Duration of treatment (a) Specifications. Each bolus contains is usually 3 to 5 days. Continue treat- ampicillin trihydrate equivalent to 400 ment 48 hours after the animal’s tem- milligrams of ampicillin. perature has returned to normal and (b) Sponsors. See sponsor numbers in all other signs of infection have sub- § 510.600(c) of this chapter as follows: sided. (1) No. 055529 for use as in paragraph (ii) Indications for use. Treatment of (d)(1) of this section; respiratory tract infections (bacterial (2) No. 054771 for use as in paragraph pneumonia) due to Staphylococcus spp., (d)(2) of this section. Streptococcus spp., E. coli, and Proteus (c) Related tolerances. See § 556.40 of spp.; urinary tract infections (cystitis) this chapter.

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(d) Conditions of use. Nonruminating cent amprolium-medicated water for calves—(1) Amount. 5 milligrams per an additional 1 to 2 weeks. pound of body weight twice daily for up (ii) Indications for use. For the treat- to 5 days. ment of coccidiosis. (i) Indications for use. Oral treatment (iii) Limitations. Use as the sole of colibacillosis caused by Escherichia source of amprolium. coli, bacterial enteritis caused by Sal- (2) Calves. Administer crumbles top- monella spp., and bacterial pneumonia dressed on or thoroughly mixed in the caused by Pasteurella spp. daily feed ration; administer con- (ii) Limitations. Treated calves must centrate solution or soluble powder as not be slaughtered for food during a drench or in drinking water as fol- treatment and for 15 days after the last lows: treatment. Federal law restricts this (i) Indications for use and amounts— drug to use by or on the order of a li- (A) As an aid in the prevention of coc- censed veterinarian. cidiosis caused by Eimeria bovis and E. (2) Amount. 5 milligrams per pound of zurnii, administer 5 mg per kilogram body weight twice daily not to exceed 4 (mg/kg) body weight for 21 days during days. periods of exposure or when experience (i) Indications for use. Oral treatment indicates that coccidiosis is likely to of bacterial enteritis (colibacillosis) be a hazard. caused by E. coli. (B) As an aid in the treatment of coc- (ii) Limitations. Treated calves must cidiosis caused by E. bovis and E. zurnii, not be slaughtered for food during administer 10 mg/kg body weight for 5 treatment and for 7 days after the last days. treatment. Federal law restricts this (ii) Limitations. Withdraw 24 hours be- drug to use by or on the order of a li- fore slaughter. A withdrawal period has censed veterinarian. not been established for this product in [57 FR 37322, Aug. 18, 1992, as amended at 58 preruminating calves. Do not use in FR 61016, Nov. 19, 1993; 60 FR 55659, Nov. 2, calves to be processed for veal. Use as 1995; 79 FR 28818, May 20, 2014] the sole source of amprolium. § 520.100 Amprolium. [71 FR 56346, Sept. 27, 2006, as amended at 72 FR 60551, Oct. 25, 2007; 73 FR 45611, Aug. 6, (a) Specifications. (1) Each milliliter 2008; 73 FR 70276, Nov. 20, 2008; 74 FR 10484, of solution contains 96 milligrams (mg) Mar. 11, 2009; 76 FR 38554, July 1, 2011; 76 FR amprolium (9.6 percent solution). 40808, July 12, 2011; 78 FR 23, Jan. 2, 2013; 78 (2) Each gram of powder contains 200 FR 17596, Mar. 22, 2013; 78 FR 57058, Sept. 17, mg amprolium (20 percent). 2013; 81 FR 22523, Apr. 18, 2016; 81 FR 59133, (3) Each ounce (28.4 grams) of crum- Aug. 29, 2016] bles contains 355 mg amprolium (1.25 percent). § 520.110 Apramycin sulfate soluble powder. (b) Sponsors. See sponsors in 510.600(c) of this chapter. (a) Specifications. A water soluble (1) No. 016592 for use of products de- powder used to make a medicated scribed in paragraph (a) of this section drinking water containing apramycin as in paragraph (d) of this section. sulfate equivalent to 0.375 gram of (2) No. 066104 for use of product de- apramycin activity per gallon of drink- scribed in paragraph (a)(1) of this sec- ing water. tion as in paragraph (d) of this section. (b) Sponsor. See No. 058198 in (c) Related tolerances. See § 556.50 of § 510.600(c) of this chapter. this chapter. (c) Related tolerances. See § 556.52 of (d) Conditions of use—(1) Growing this chapter. chickens, turkeys, and laying hens. It is (d) Conditions of use in swine—(1) used in drinking water as follows: Amount. Administer in drinking water (i) Amount. Administer at the 0.012 at the rate of 12.5 milligrams of percent level in drinking water as soon apramycin per kilogram (5.7 milli- as coccidiosis is diagnosed and con- grams per pound) of body weight per tinue for 3 to 5 days (in severe out- day for 7 days. breaks, give amprolium at the 0.024 (2) Indications for use. For the control percent level); continue with 0.006 per- of porcine colibacillosis (weanling pig

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scours) caused by strains of Escherichia (ii) Indications for use. Treatment of coli sensitive to apramycin. swine dysentery associated with (3) Limitations. Do not slaughter Brachyspira hyodysenteriae. Administer treated swine for 28 days following continuously for 7 days or until signs treatment. Federal law restricts this of dysentery disappear. drug to use by or on the order of a li- (iii) Limitations. Prepare a fresh solu- censed veterinarian. tion daily. Treatment not to exceed 14 [47 FR 15771, Apr. 13, 1982, as amended at 49 days. If symptoms persist after 4 to 5 FR 19642, May 9, 1984; 53 FR 37753, Sept. 28, days consult a veterinarian. Not to be 1988; 79 FR 28818, May 20, 2014; 81 FR 48702, given to swine that weigh more than July 26, 2016; 81 FR 94989, Dec. 27, 2016] 250 pounds. (4) Growing quail—(i) Amount. 400 mg § 520.154 Bacitracin oral dosage forms. per gal in drinking water. § 520.154a Bacitracin (ii) Indications for use. For prevention methylenedisalicylate. of ulcerative enteritis due to Clos- (a) Specifications. Each pound of solu- tridium colinum susceptible to baci- ble powder contains the equivalent of tracin methylenedisalicylate. 50 grams of bacitracin activity for use (iii) Limitations. Prepare fresh solu- as in paragraph (d)(1) or (d)(2) of this tion daily. Use as sole source of drink- section, or the equivalent of 200 grams ing water. of bacitracin activity for use as in [57 FR 37322, Aug. 18, 1992; 57 FR 42623, Sept. paragraph (d) of this section. 15, 1992, as amended at 63 FR 38474, July 17, (b) Sponsor. See No. 054771 in 1998; 64 FR 13068, Mar. 17, 1999; 76 FR 53050, § 510.600(c) of this chapter. Aug. 25, 2011; 79 FR 28818, May 20, 2014; 80 FR (c) Related tolerances. See § 556.70 of 34278, June 16, 2015] this chapter. (d) Conditions of use—(1) Growing tur- § 520.154b Bacitracin keys—(i) Amount. 400 milligrams (mg) methylenedisalicylate and strepto- per gallon (gal) in drinking water. mycin sulfate powder. (ii) Indications for use. Aid in the con- (a) Specifications. Each gram of pow- trol of transmissible enteritis com- der contains 200 units bacitracin plicated by organisms susceptible to methylenedisalicylate and strepto- bacitracin methylenedisalicylate. mycin sulfate equivalent to 20 milli- (iii) Limitations. Prepare a fresh solu- grams of streptomycin. tion daily. (b) Sponsor. See No. 054771 in (2) Broiler and replacement chickens— § 510.600(c) of this chapter. (i) Amount. 100 mg per gal in drinking (c) Conditions of use in dogs—(1) water. Amount. Administer 1 level teaspoonful (A) Indications for use. Aid in the pre- per 10 pounds of body weight three vention of necrotic enteritis caused by times daily, mixed in a small quantity Clostridium perfringens susceptible to of liquid or feed. bacitracin methylenedisalicylate. (2) Indications for use. For the treat- (B) Limitations. Prepare a fresh solu- ment of bacterial enteritis caused by tion daily. pathogens susceptible to bacitracin and (ii) Amount. 200 to 400 mg per gal in streptomycin such as Escherichia coli, drinking water. Administer continu- Proteus spp., Staphylococcus spp., and ously 5 to 7 days or as long as clinical Streptococcus spp., and for the sympto- signs persist, then reduce to prevention matic treatment of associated diar- levels (100 mg/gal). rhea. (A) Indications for use. Treatment of necrotic enteritis caused by C. (3) Limitations. Federal law restricts perfringens susceptible to bacitracin this drug to use by or on the order of a methylenedisalicylate. licensed veterinarian. (B) Limitations. Prepare a fresh solu- [71 FR 17702, Apr. 7, 2006, as amended at 79 tion daily. FR 28818, May 20, 2014; 81 FR 17607, Mar. 30, (3) Swine—(i) Amount. 1 gram per gal- 2016] lon in drinking water.

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§ 520.154c Bacitracin zinc soluble pow- kilogram of body weight. The drug der. should be given on an empty stomach (a) Specifications. Each pound con- and food should not be given for 3 tains the equivalent of not less than 5 hours following treatment. grams of bacitracin. (3) Tablets should not be crushed, (b) Sponsor. See No. 054771 in mixed with food, or dissolved in liquid. § 510.600(c) of this chapter. Repeat treatments should not be given (c) Related tolerances. See § 556.70 of within 14 days. The drug should not be this chapter. given to male dogs within 28 days prior (d) Conditions of use—(1) Broiler chick- to their use for breeding. Do not ad- ens—(i) Amount. 100 milligrams per gal- minister to dogs or cats having known lon in drinking water. heart conditions. (A) Indications for use. Prevention of (4) For use only by or on the order of necrotic enteritis caused by Clostridium a licensed veterinarian. perfringens susceptible to bacitracin [40 FR 13838, Mar. 27, 1975, as amended at 42 zinc. FR 13018, Mar. 8, 1977; 46 FR 48642, Oct. 2, (B) Limitations. Prepare a fresh solu- 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, tion daily. Nov. 19, 1997] (ii) Amount. 200 to 400 milligrams per gallon in drinking water. § 520.246 Butorphanol tablets. (A) Indications for use. Control of ne- (a) Specifications. Each tablet con- crotic enteritis caused by Clostridium tains butorphanol tartrate equivalent perfringens susceptible to bacitracin to 1, 5, or 10 milligrams (mg) zinc. butorphanol base. (B) Limitations. Prepare a fresh solu- (b) Sponsor. See No. 054771 in tion daily. § 510.600(c) of this chapter. (2) Growing quail—(i) Amount. 500 mil- (c) Conditions of use in dogs—(1) ligrams per gallon in drinking water Amount. Administer 0.25 mg for 5 days followed by 165 milligrams butorphanol base per pound of body per gallon in drinking water for 10 weight. Repeat at intervals of 6 to 12 days. hours as required. Treatment should (ii) Indications for use. Control of ul- not normally be required for longer cerative enteritis caused by Clostridium than 7 days. spp. susceptible to bacitracin zinc. (2) Indications for use. For the relief of (iii) Limitations. Prepare a fresh solu- chronic nonproductive cough associ- tion daily. ated with tracheobronchitis, tracheitis, tonsillitis, laryngitis, and pharyngitis [57 FR 37322, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002; 79 FR 28818, May 20, associated with inflammatory condi- 2014] tions of the upper respiratory tract. (3) Limitations. Federal law restricts § 520.222 Bunamidine hydrochloride. this drug to use by or on the order of a (a) Chemical name. N,N-Dibutyl-4- licensed veterinarian. (hexyloxy)-1-naphthamidine hydro- [79 FR 28818, May 20, 2014] chloride. (b) Specifications. The drug is an oral § 520.260 n-Butyl chloride. tablet containing 100, 200, or 400 milli- (a)(1) Specifications. n-Butyl chloride grams of bunamidine hydrochloride. capsules, veterinary contain 272 milli- (c) Sponsor. See No. 000061 in grams or 816 milligrams of n-butyl § 510.600(c) of this chapter. chloride in each capsule. (d) Conditions of use. (1) The drug is (2) Sponsor. See No. 021091 in intended for oral administration to § 510.600(c) of this chapter. dogs for the treatment of the tape- (3) Conditions of use. (i) It is used for worms Dipylidium caninum, Taenia the removal of ascarids (Toxocara canis pisiformis, and Echinococcus granulosus, and Toxascaris leonina) and hookworms and to cats for the treatment of the (Ancylostoma caninum, Ancylostoma tapeworms Dipylidium caninum and braziliense, and Uncinaria stenocephala) Taenia taeniaeformis. from dogs and of the ascarid (Toxocara (2) It is administered to cats and dogs cati) and hookworm (Ancylostoma at the rate of 25 to 50 milligrams per tubaeforme) from cats.

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(ii)(a) Animals should not be fed for sules; No. 038782 for 884 or 1,768 milli- 18 to 24 hours before being given the gram or 4.42 gram capsules; and No. drug. Puppies and kittens should be 054771 for 221 milligram capsules. wormed at 6 weeks of age. However, if (3) Conditions of use. (i) It is used for heavily infested, they may be wormed the removal of ascarids (Toxocara canis at 4 or 5 weeks of age. Administration and Toxascaris leonina) and hookworms of the drug should be followed in 1⁄2 to (Ancylostoma caninum, Ancylostoma 1 hour with a teaspoonful to a table- braziliense, and Uncinaria stenocephala) spoonful of milk of magnesia or 1 or 2 from dogs. milk of magnesia tablets. Normal ra- (ii)(a) Dogs should not be fed for 18 to tions may be resumed 4 to 8 hours after 24 hours before being given the drug. treatment. Puppies and kittens should be given a repeat treatment in a week Administration of the drug should be 1 or 10 days. After that they should be followed in ⁄2 to 1 hour with a mild ca- treated every 2 months (or as symp- thartic. Normal feeding may be re- toms reappear) until a year old. When sumed 4 to 8 hours after treatment. the puppy or kitten is a year old, one Animals subject to reinfection may be treatment every 3 to 6 months is suffi- retreated in 2 weeks. cient. (b) The drug is administered orally to (b) For dogs or cats that have been dogs. Capsules containing 221 milli- wormed regularly, treatment every 3 to grams of n-butyl chloride are adminis- 6 months will be sufficient. If a dog or tered to dogs weighing under 5 pounds cat has not been wormed previously at a dosage level of 1 capsule per 11⁄4 and has the symptoms of large pound of body weight. Capsules con- roundworms a dose should be given and taining 442 milligrams of n-butyl chlo- repeated in 10 days. Removal of ride are administered to dogs weighing hookworms may require 3 or 4 doses at under 5 pounds at a dosage level of 1 10-day intervals. capsule per 21⁄2 pounds body weight. (c) Puppies, dogs, cats, or kittens Capsules containing 884 milligrams of weighing 1 to 3 pounds should be given n-butyl chloride are administered to 2 capsules per dose which contain 272 dogs as follows: Weighing under 5 milligrams of n-butyl chloride each. pounds, 1 capsule; weighing 5 to 10 Such animals weighing 4 to 5 pounds pounds, 2 capsules; weighing 10 to 20 should be given 3 such capsules. Ani- pounds, 3 capsules; weighing 20 to 40 mals weighing 6 to 7 pounds should be given 4 such capsules and animals pounds, 4 capsules; over 40 pounds, 5 weighing 8 to 9 pounds should be given capsules. Capsules containing 1,768 mil- 5 such capsules. Animals weighing 10 to ligrams of n-butyl chloride are admin- 20 pounds should be given 3 capsules istered at a dosage level of 1 capsule which contain 816 milligrams of n- per dog weighing 5 to 10 pounds. Cap- butyl chloride each, animals weighing sules containing 4.42 grams of n-butyl 20 to 40 pounds should be given 4 such chloride are administered at a dosage capsules and animals weighing over 40 level of 1 capsule per dog weighing 40 pounds should be given 5 such capsules pounds or over. with the maximum dosage being 5 cap- (iii) A veterinarian should be con- sules, each of which contains 816 milli- sulted before using in severely debili- grams of n-butyl chloride. tated dogs. (iii) A veterinarian should be consulted before using in severely debili- [40 FR 13838, Mar. 27, 1975, as amended at 40 tated dogs or cats and also prior to re- FR 39858, Aug. 29, 1975; 44 FR 10059, Feb. 16, peated use in cases which present signs 1979; 54 FR 38515, Sept. 19, 1989; 55 FR 24556, June 18, 1990; 64 FR 15684, Apr. 1, 1999; 70 FR of persistent parasitism. 50182, Aug. 26, 2005; 78 FR 14669, Mar. 7, 2013; (b)(1) Specifications. n-Butyl chloride 79 FR 28818, May 20, 2014] capsules contain 221, 442, 884, or 1,768 milligrams or 4.42 grams of n-butyl EDITORIAL NOTE: At 78 FR 14669, Mar. 7, chloride in each capsule. 2013, § 520.260 was amended by adding para- (2) Sponsors. See No. 023851 in graphs (b)(1) through (3); however, the § 510.600(c) of this chapter for 221, 442, amendment could not be incorporated because (b)(1) through (3) already existed. 884, or 1,768 milligram or 4.42 gram cap-

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§ 520.284 Cambendazole oral dosage (3) Limitations. Do not administer to forms. pregnant mares during first 3 months of pregnancy. Do not use in horses in- § 520.284a Cambendazole suspension. tended for human consumption. Con- (a) Specifications. Each fluid ounce sult your veterinarian for assistance in contains 0.9 gram of cambendazole. the diagnosis, treatment, and control (b) Sponsor. No. 050604 in § 510.600(c) of of parasitism. this chapter. [41 FR 1276, Jan. 7, 1976, as amended at 42 FR (c) Conditions of use in horses—(1) 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997; Amount. Administer by stomach tube 79 FR 28818, May 20, 2014. Redesignated at 81 or as a drench at a dose of 0.9 gram of FR 59133, Aug. 29, 2016] cambendazole per 100 pounds of body § 520.284c Cambendazole paste. weight (20 milligrams per kilogram). (2) Indications for use. For the control (a) Specifications. The drug is a paste of large strongyles (Strongylus vulgaris, containing 45 percent cambendazole. S. edentatus, S. equinus); small (b) Sponsor. No. 050604 in § 510.600(c) of strongyles (Trichonema, Poteriostomum, this chapter. (c) Conditions of use in horses—(1) Cylicobrachytus, Craterostomum, Amount. Administer 20 milligrams Oesophagodontus); roundworms cambendazole per kilogram body (Parascaris); pinworms (Oxyuris); and weight (5 grams per 550 pounds (250 threadworms (Strongyloides). kilograms)) by depositing the paste on (3) Limitations. Do not use in horses the back of the tongue using a dosing intended for human consumption. Fed- gun. For animals maintained on prem- eral law restricts this drug to use by or ises where reinfection is likely to on the order of a licensed veterinarian. occur, re-treatments may be necessary. [40 FR 13838, Mar. 27, 1975. Redesignated at 41 For most effective results, re-treat in 6 FR 1276, Jan. 7, 1976, and amended at 42 FR to 8 weeks. 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997; (2) Indications for use. For the control 79 FR 28818, May 20, 2014. Redesignated at 81 of large strongyles (Strongylus vulgaris, FR 59133, Aug. 29, 2016] S. edentatus, S. equinus); small strongyles (Trichonema, Poteriostomum, § 520.284b Cambendazole pellets. Cylicobrachytus, Craterostomum, (a) Specifications. The drug is in feed Oesophagodontus); roundworms pellets containing 5.3 percent (Parascaris); pinworms (Oxyuris); and cambendazole. threadworms (Strongyloides). (b) Sponsor. No. 050604 in § 510.600(c) of (3) Limitations. Do not administer to this chapter. pregnant mares during first 3 months (c) Conditions of use in horses—(1) of pregnancy. Do not use in horses in- Amount. Administer 20 milligrams tended for human consumption. Con- cambendazole per kilogram body sult your veterinarian for assistance in weight (6 ounces per 1,000 pounds) by the diagnosis, treatment, and control mixing with normal grain ration given of parasitism. at one feeding. Doses for individual [41 FR 1276, Jan. 7, 1976, as amended at 42 FR horses should be mixed and fed sepa- 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997; rately to assure that each horse will 79 FR 28819, May 20, 2014. Redesignated at 81 consume the correct amount. For ani- FR 59133, Aug. 29, 2016] mals maintained on premises where reinfection is likely to occur, re-treat- § 520.292 Capromorelin. ments may be necessary. For most ef- (a) Specifications. Each milliliter of fective results, re-treat in 6 to 8 weeks. solution contains 30 milligrams (mg) (2) Indications for use. For the control capromorelin. of large strongyles (Strongylus vulgaris, (b) Sponsor. See No. 086026 in S. edentatus, S. equinus); small § 510.600(c) of this chapter. strongyles (Trichonema, Poteriostomum, (c) Conditions of use in dogs—(1) Cylicobrachytus, Craterostomum, Amount. Administer 3 mg/kg once daily Oesophagodontus); roundworms by mouth. (Parascaris); pinworms (Oxyuris); and (2) Indications for use. For appetite threadworms (Strongyloides). stimulation in dogs.

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(3) Limitations. Federal law restricts (2) No. 000859 for use of product de- this drug to use by or on the order of a scribed in paragraph (a)(1) as in para- licensed veterinarian. graph (d) of this section. (c) [Reserved] [81 FR 59133, Aug. 29, 2016] (d) Conditions of use in dogs—(1) Amount. 2 mg per pound (/lb) of body § 520.301 Caramiphen ethanedisulfonate and ammonium weight once daily or 1 mg/lb twice chloride tablets. daily. For the control of postoperative pain, administer approximately 2 hours (a) Specifications. Each tablet con- before the procedure. tains 10 milligrams of 5st caramiphen (2) Indications for use. For the relief of ethanedisulfonate and 80 milligrams of pain and inflammation associated with ammonium chloride. osteoarthritis and for the control of (b) Sponsor. See No. 054771 in postoperative pain associated with soft § 510.600(c) of this chapter. tissue and orthopedic surgeries. (c) Conditions of use in dogs—(1) (3) Limitations. Federal Law restricts Amount. One tablet per 15 to 30 pounds this drug to use by or on the order of a of body weight every 4 to 6 hours. licensed veterinarian. (2) Indications for use. For relief of cough. [61 FR 66581, Dec. 18, 1996, as amended at 64 FR 32181, June 16, 1999; 66 FR 63165, Dec. 5, [43 FR 55385, Nov. 28, 1978, as amended at 79 2001; 67 FR 6866, Feb. 14, 2002; 67 FR 65038, FR 28819, May 20, 2014. Redesignated at 80 FR Oct. 23, 2002; 67 FR 65697, Oct. 28, 2002; 70 FR 13229, Mar. 13, 2015] 30626, May 27, 2005; 71 FR 51995, Sept. 1, 2006; 72 FR 68478, Dec. 5, 2007; 74 FR 21768, May 11, § 520.302 Carnidazole tablets. 2009; 78 FR 52853, Aug. 27, 2013; 78 FR 66264, Nov. 5, 2013; 79 FR 28819, May 20, 2014. Redes- (a) Specifications. Each tablet con- ignated and amended at 80 FR 13229, Mar. 13, tains 10 milligrams of carnidazole. 2015; 80 FR 34278, June 16, 2015; 80 FR 61296, (b) Sponsor. See 053923 in § 510.600(c) of Oct. 13, 2015; 82 FR 43484, Sept. 18, 2017] this chapter. (c) Conditions of use—(1) Amount. § 520.314 Cefadroxil. Adult pigeons: 1 tablet (10 milligrams); (a) Specifications. (1) Each tablet con- newly weaned pigeons: 1⁄2 tablet (5 mil- tains 50, 100, or 200 milligrams (mg) or ligrams). 1 gram of cefadroxil. (2) Indications for use. For treating (2) Each milliliter of suspension con- trichomoniasis (canker) in ornamental stituted from powder contains 50 mg of and homing pigeons. cefadroxil. (3) Limitations. Not for use in pigeons (b) Sponsor. See No. 000010 in intended for human food. Consult your § 510.600(c) of this chapter. veterinarian for assistance in the diag- (c) Conditions of use in dogs and cats— nosis, treatment, and control of para- (1) Amount—(i) Dogs. Administer 10 mg sitism or when severely ill birds do not per pound (/lb) body weight twice daily respond to treatment. orally. (ii) Cats. Administer 10 mg/lb body [54 FR 32336, Aug. 7, 1989. Redesignated at 80 weight once daily orally. FR 13229, Mar. 13, 2015] (2) Indications for use—(i) Dogs. For the treatment of skin and soft tissue § 520.304 Carprofen. infections including cellulitis, (a) Specifications. (1) Each caplet con- pyoderma, dermatitis, wound infec- tains 25, 75, or 100 milligrams (mg) tions, and abscesses due to susceptible carprofen. strains of Staphylococcus aureus. For (2) Each chewable tablet contains 25, the treatment of genitourinary tract 75, or 100 mg carprofen. infections (cystitis) due to susceptible (b) Sponsors. See sponsors in strains of Escherichia coli, Proteus § 510.600(c) of this chapter for uses as in mirabilis, and S. aureus. paragraph (d) of this section. (ii) Cats. For the treatment of skin (1) Nos. 054771, 026637, 055529, and and soft tissue infections including ab- 062250 for use of products described in scesses, wound infections, cellulitis, paragraph (a) as in paragraph (d) of and dermatitis caused by susceptible this section. strains of Pasteurella multocida, S.

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aureus, Staphylococcus epidermidis, and strains of Staphylococcus Streptococcus spp. pseudintermedius. (3) Limitations. Federal law restricts (iii) Limitations. Federal law restricts this drug to use by or on the order of a this drug to use by or on the order of a licensed veterinarian. licensed veterinarian. [75 FR 10165, Mar. 5, 2010] (2) [Reserved] [77 FR 47512, Aug. 9, 2012] § 520.370 Cefpodoxime tablets. (a) Specifications. (1) Each tablet con- § 520.390 Chloramphenicol oral dosage tains cefpodoxime proxetil equivalent forms. to 100 or 200 milligrams (mg) cefpodoxime. § 520.390a Chloramphenicol tablets. (2) Each chewable tablet contains (a) Specifications. Each tablet con- cefpodoxime proxetil equivalent to 100 tains 50, 100, 250, or 500 milligrams or 200 mg cefpodoxime. (mg); 1 or 2.5 grams (g) of chloramphen- (b) Sponsors. See sponsors in icol. § 510.600(c) of this chapter for uses as (b) Sponsors. See § 510.600(c) of this follows: chapter: (1) No. 026637 for use of product in (1) For use as in paragraphs (c)(1), paragraph (a)(1) of this section as in (c)(2)(i), and (c)(3) of this section: paragraph (c) of this section. (2) No. 054771 for use of products in (i) No. 054628 for 100-, 250-, and 500-mg; paragraph (a) of this section as in para- and 1- and 2.5-g tablets; graph (c) of this section. (ii) No. 054771 for 100-, 250-, and 500- (c) Conditions of use in dogs—(1) mg tablets; Amount. 5 to 10 mg per kilogram (2.3 to (2) For use as in paragraphs (c)(1), 4.5 mg per pound) body weight daily for (c)(2)(ii), and (c)(3) of this section: 5 to 7 days, or for 2 to 3 days beyond (i) No. 061623 for 50-, 100-, 250-, and the cessation of clinical signs, up to a 500-mg; and 1-g tablets; maximum of 28 days. (ii) [Reserved] (2) Indications for use. For the treat- (c) Conditions of use in dogs—(1) ment of skin infections (wounds and Amount. Administer 25 mg per pound of abscesses) caused by susceptible strains body weight by mouth every 6 hours. of Staphylococcus pseudintermedius, S. (2) Indications for use—(i) For the aureus, Streptococcus canis (group G, treatment of bacterial pulmonary in- beta-hemolytic), Escherichia coli, fections, bacterial infections of the uri- Pasteurella multocida, and Proteus nary tract, bacterial enteritis, and bac- mirabilis. terial infections associated with canine (3) Limitations. Federal law restricts distemper caused by susceptible orga- this drug to use by or on the order of a nisms. licensed veterinarian. (ii) For the treatment of bacterial [69 FR 52815, Aug. 30, 2004, as amended at 78 gastroenteritis associated with bac- FR 5714, Jan. 28, 2013; 79 FR 28819, May 20, terial diarrhea, bacterial pulmonary 2014; 80 FR 13229, Mar. 13, 2015; 82 FR 12169, infections, and bacterial infections of Mar. 1, 2017] the urinary tract caused by susceptible organisms. § 520.376 Cephalexin. (3) Limitations. Federal law restricts (a) Specifications. Each chewable tab- this drug to use by or on the order of a let contains 75, 150, 300, or 600 milli- licensed veterinarian. Federal law programs (mg) cephalexin. hibits the extralabel use of this drug in (b) Sponsor. See No. 051311 in food-producing animals. § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) [77 FR 4896, Feb. 1, 2012, as amended at 78 FR Amount. Administer 22 mg per kilo- 21059, Apr. 9, 2013; 79 FR 28819, May 20, 2014] gram of body weight twice daily for 28 days. § 520.390b Chloramphenicol capsules. (ii) Indications for use. For the treat- (a) Specifications. Each capsule con- ment of secondary superficial bacterial tains 50, 100, 250, or 500 milligrams (mg) pyoderma in dogs caused by susceptible chloramphenicol.

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(b) Sponsors. See Nos. 050057 and (3) Conditions of use—(i) Amount. 054771 in § 510.600(c) of this chapter for Usual dosage is 5 to 10 milligrams per use as in paragraph (d) of this section. pound of body weight two or three (c) Special considerations. Federal law times daily. prohibits the extralabel use of this (ii) Indications for use. For use in dogs product in food-producing animals. for treatment of congestive heart fail- (d) Conditions of use in dogs—(1) ure and renal edema. Amount. 25 mg per pound of body (iii) Limitations. (a) Dosage must be weight every 6 hours. adjusted to meet the changing needs of (2) Indications for use. For treatment the individual animal. In mild and re- of bacterial pulmonary infections, bac- sponsive cases, it is suggested that a terial infections of the urinary tract, dose of 5 milligrams per pound of body bacterial enteritis, and bacterial infec- weight be administered two or three tions associated with canine distemper times daily. In moderately edematous caused by susceptible organisms. and moderately responsive animals, a (3) Limitations. Federal law restricts dose of 7.5 to 10 milligrams per pound this drug to use by or on the order of a of body weight may be administered licensed veterinarian. three times daily. Severe conditions [70 FR 75398, Dec. 20, 2005, as amended at 73 may require higher doses. Certain ani- FR 18442, Apr. 4, 2008; 75 FR 55676, Sept. 14, mals may respond adequately to inter- 2010; 79 FR 28819, May 20, 2014] mittent therapy; in these cases, the drug may be administered either every § 520.390c Chloramphenicol palmitate other day or for 3 to 5 days each week. oral suspension. (b) Animals should be regularly and (a) Specifications. Each milliliter con- carefully observed for early signs of tains chloramphenicol palmitate equiv- fluid and electrolyte imbalance. Take alent to 30 milligrams of chloramphen- appropriate countermeasures if this icol. should occur. In some dogs, (b) Sponsor. See No. 054771 in hypochloremic alkalosis may occur § 510.600(c) of this chapter. (that is, excretion of chloride in rela- (c) Conditions of use. Dogs—(1) tion to sodium is excessive; the plasma Amount. 25 milligrams per pound of bicarbonate level increases and body weight every 6 hours. If no re- alkalosis results). Federal law restricts sponse is obtained in 3 to 5 days, dis- this drug to use by or on the order of a continue use and reevaluate diagnosis. licensed veterinarian. (2) Indications for use. Treatment of (b)(1) Specifications. Each bolus con- bacterial pulmonary infections, infec- tains 2 grams of chlorothiazide. tions of the urinary tract, enteritis, (2) Sponsor. See No. 000006 in and infections associated with canine § 510.600(c) of this chapter. distemper that are caused by orga- (3) Conditions of use—(i) Amount. 2 nisms susceptible to chloramphenicol. grams once or twice daily for 3 or 4 (3) Limitations. Not for use in animals days. that are raised for food production. (ii) Indications for use. For use in cat- Must not be used in meat-, egg-, or tle as an aid in reduction of milk-producing animals. The length of postparturient udder edema. time that residues persist in milk or (iii) Limitations. Animals should be tissues has not been determined. Fed- regularly and carefully observed for eral law restricts this drug to use by or early signs of fluid and electrolyte im- on the order of a licensed veterinarian. balance. Take appropriate countermeasures if this should occur. Milk [57 FR 37323, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 79 FR 28819, May 20, taken from dairy animals during treat- 2014] ment and for 72 hours (six milkings) after latest treatment must not be § 520.420 Chlorothiazide tablets and used for food. Federal law restricts this boluses. drug to use by or on the order of a li- (a)(1) Specifications. Each tablet con- censed veterinarian. tains 0.25 gram of chlorothiazide. [43 FR 39085, Sept. 1, 1978, as amended at 62 (2) Sponsor. See No. 050604 in FR 63270, Nov. 28, 1997; 79 FR 28819, May 20, § 510.600(c) of this chapter. 2014]

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§ 520.434 Chlorphenesin carbamate (i) Swine—(A) Amount. Ten milli- tablets. grams per pound of body weight daily (a) Specifications. Each tablet con- in divided doses. tains 400 milligrams of chlorphenesin (1) Indications for use. Control and carbamate. treatment of bacterial enteritis (scours) caused by Escherichia coli and (b) Sponsor. See No. 054771 in bacterial pneumonia associated with § 510.600(c) of this chapter. Pasteurella spp., Actinobacillus (c) Conditions of use in dogs—(1) pleuropneumoniae (Haemophilus spp.), Amount. 50 milligrams per pound of and Klebsiella spp. body weight on first day; 25 milligrams (2) Limitations. Prepare a fresh solu- per pound of body weight each fol- tion twice daily; as sole source of lowing day. Divide total daily dose into chlortetracycline; administer for not 2 or 3 equal doses—administer at 12- or more than 5 days. Federal law restricts 8-hour intervals. this drug to use by or on the order of a (2) Indications for use. For use as an licensed veterinarian. adjunct to therapy of acute inflam- (B) [Reserved] matory and traumatic conditions of (ii) [Reserved] skeletal muscles. The drug provides re- (2) Use as chlortetracycline hydro- lief of the signs of discomfort associ- chloride in a drench or drinking water ated with myositis, muscle sprains, as follows: traumatic injuries, stifle injuries—es- (i) Calves—(A) Amount. Ten milli- pecially when administered before or grams per pound of body weight daily after surgery—and invertebral disc in divided doses. syndrome (can be used concurrently (1) Control and treatment of bac- with adrenal corticosteroids). terial enteritis (scours) caused by E. (3) Limitations. Federal law restricts coli and bacterial pneumonia (shipping this drug to use by or on the order of a fever) associated with Pasteurella spp., licensed veterinarian. A. pleuropneumoniae (Haemophilus spp.), [44 FR 16009, Mar. 16, 1979, as amended at 79 and Klebsiella spp. FR 28819, May 20, 2014] (2) Limitations. Prepare fresh solution daily; as sole source of chlortetra- § 520.441 Chlortetracycline powder. cycline; administer for not more than 5 days; do not slaughter animals for food (a) Specifications. Chlortetracycline within 24 hours of treatment; do not powder contains not less than 15 milli- administer this product with milk or grams per gram chlortetracycline hy- milk replacers; administer 1 hour be- drochloride, or chlortetracycline bisul- fore or 2 hours after feeding milk or fate equivalent to 25.6, 64 or 102.4 grams milk replacers; a withdrawal period has per pound (56.4, 141 or 225.6 milligrams not been established in preruminating per gram) chlortetracycline hydro- calves; do not use in calves to be proc- chloride. essed for veal. Federal law restricts (b) Sponsors. See sponsors in this drug to use by or on the order of a § 510.600(c) of this chapter for use as in licensed veterinarian. paragraph (d) of this section. (B) [Reserved] (1) Nos. 000010, 016592, 054771, and (ii) [Reserved] 069254 for use as in paragraph (d) of this (3) [Reserved] section. (4) The following uses of chlortetra- (2) No. 066104 for use as in paragraphs cycline hydrochloride or chlortetra- (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) cycline bisulfate in drinking water or through (d)(4)(iv) of this section. drench were reviewed by the National (3) Nos. 069254 and 076475 for use as in Academy of Sciences/National Re- paragraphs (d)(4)(i)(A), (d)(4)(i)(B), search Council (NAS/NRC) and found (d)(4)(ii), and (d)(4)(iii) of this section. effective: (c) Related tolerances. See § 556.150 of (i) Chickens—(A) Amount. 200 to 400 this chapter. milligrams per gallon. (d) Conditions of use. (1) Use as chlor- (1) Indications for use. Control of in- tetracycline hydrochloride in drinking fectious synovitis caused by Myco- water as follows: plasma synoviae.

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(2) Limitations. Prepare fresh solution (B) Indications for use. Control and daily; as sole source of chlortetra- treatment of bacterial enteritis cycline; do not use for more than 14 (scours) caused by E. coli and Sal- days; do not slaughter animals for food monella spp. and bacterial pneumonia within 24 hours of treatment; do not associated with Pasteurella spp., use in laying chickens. Federal law re- Actinobacillus pleuropneumoniae stricts this drug to use by or on the (Haemophilus spp.), and Klebsiella spp. order of a licensed veterinarian. (C) Limitations. Prepare fresh solution (B) Amount. 400 to 800 milligrams per daily; as sole source of chlortetra- gallon. cycline; do not use for more than 5 (1) Indications for use. Control of days. For Nos. 016592 and 021930, do not chronic respiratory disease and air-sac slaughter animals for food within 5 infections caused by M. gallisepticum days of treatment. For No. 016592, do and E. coli. not slaughter animals for food within (2) Limitations. Prepare fresh solution 24 hours of treatment. Federal law re- daily; as sole source of chlortetra- stricts this drug to use by or on the cycline; do not use for more than 14 order of a licensed veterinarian. days; do not slaughter animals for food (iv) Calves, beef cattle, and nonlac- within 24 hours of treatment; do not tating dairy cattle—(A) Amount. 10 milli- use in laying chickens. Federal law re- grams per pound daily in divided doses. stricts this drug to use by or on the (B) Indications for use. Control and order of a licensed veterinarian. treatment of bacterial enteritis (C) Amount. One thousand milligrams (scours) caused by E. coli and Sal- per gallon. monella spp. and bacterial pneumonia (1) Indications for use. Control of mor- (shipping fever complex) associated tality due to fowl cholera caused by with Pasteurella spp., A. Pasteurella multocida susceptible to pleuropneumoniae (Haemophilus spp.), chlortetracycline. and Klebsiella spp. (2) Limitations. See paragraph (C) Limitations. Prepare fresh solution (d)(4)(i)(A)(2) of this section. daily; use as a drench; as sole source of (ii) Growing turkeys—(A) Amount. 400 chlortetracycline; do not use for more milligrams per gallon. than 5 days; do not slaughter animals (1) Indications for use. Control of infor food within 24 hours of treatment; fectious synovitis caused by M. do not use in lactating cattle; do not synoviae. administer this product with milk or (2) Limitations. Prepare fresh solution milk replacers; administer 1 hour be- daily; as sole source of chlortetra- fore or 2 hours after feeding milk or cycline; do not use for more than 14 milk replacers; a withdrawal period has days; do not slaughter animals for food not been established in preruminating within 24 hours of treatment. Federal calves; do not use in calves to be proc- law restricts this drug to use by or on essed for veal. Federal law restricts the order of a licensed veterinarian. this drug to use by or on the order of a (B) Amount. 25 milligrams per pound licensed veterinarian. of body weight daily. (5) Use in a drench or drinking water (1) Indications for use. Control of com- as follows: plicating bacterial organisms associ- (i) Chickens—(A) Amount. 200 to 400 ated with bluecomb (transmissible en- mg/gal, for 7 to 14 days. teritis, coronaviral enteritis). (1) Indications for use. Control of in- (2) Limitations. Prepare fresh solution fectious synovitis caused by M. daily; as sole source of chlortetra- synoviae susceptible to chlortetracycline; do not use for more than 14 cycline. days; do not slaughter animals for food (2) Limitations. Prepare fresh solution within 24 hours of treatment. Federal daily; use as the sole source of chlor- law restricts this drug to use by or on tetracycline; do not use for more than the order of a licensed veterinarian. 14 consecutive days; do not use in lay- (iii) Swine—(A) Amount. 10 milligrams ing chickens; do not administer to per pound body weight daily in divided chickens within 24 hours of slaughter. doses. Federal law restricts this drug to use

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by or on the order of a licensed veteri- (iv) Calves, beef cattle, and nonlac- narian. tating dairy cattle—(A) Amount. 10 mg/lb (B) Amount. 400 to 800 mg/gal, for 7 to body weight daily in divided doses, for 14 days. 3 to 5 days. (1) Indications for use. Control of (B) Indications for use. Control and chronic respiratory disease (CRD) and treatment of bacterial enteritis air-sac infections caused by M. (scours) caused by Escherichia coli and gallisepticum and E. coli susceptible to Salmonella spp., and bacterial pneu- chlortetracycline. monia associated with Pasteurella spp., (2) Limitations. As in paragraph Histophilus spp., and Klebsiella spp. sus- (d)(5)(i)(A)(2) of this section. ceptible to chlortetracycline. (C) Amount. One thousand mg/gal, for (C) Limitations. Prepare fresh solution 7 to 14 days. daily; use as a drench; use as the sole source of chlortetracycline; do not use (1) Indications for use. Control of mor- for more than 5 days; do not administer tality due to fowl cholera caused by to cattle within 24 hours of slaughter; Pasteurella multocida susceptible to do not use in lactating dairy cattle; do chlortetracycline. not administer this product with milk (2) Limitations. As in paragraph or milk replacers; administer 1 hour (d)(5)(i)(A)(2) of this section. before or 2 hours after feeding milk or (ii) Growing Turkeys—(A) Amount. 400 milk replacers; a withdrawal period has mg/gal, for 7 to 14 days. not been established in preruminating (1) Indications for use. Control of in- calves; do not use in calves to be proc- fectious synovitis caused by Myco- essed for veal. Federal law restricts plasma synoviae susceptible to chlor- this drug to use by or on the order of a tetracycline. licensed veterinarian. (2) Limitations. Prepare fresh solution daily; use as the sole source of chlor- [57 FR 37324, Aug. 18, 1992] tetracycline; do not use for more than EDITORIAL NOTE: For FEDERAL REGISTER ci- 14 consecutive days; do not administer tations affecting § 520.441, see the List of CFR to growing turkeys within 24 hours of Sections Affected, which appears in the slaughter. Federal law restricts this Finding Aids section of the printed volume drug to use by or on the order of a li- and at www.fdsys.gov. censed veterinarian. § 520.443 Chlortetracycline tablets and (B) Amount. 25 mg/lb body weight boluses. daily, for 7 to 14 days. (a) Specifications. Each tablet/bolus (1) Indications for use. Control of com- contains 25, 250, or 500 milligrams (mg) plicating bacterial organisms associ- chlortetracycline hydrochloride. ated with bluecomb (transmissible en- (b) Sponsor. See Nos. 016592 and 054628 teritis, coronaviral enteritis) suscep- in § 510.600(c) of this chapter. tible to chlortetracycline. (c) Related tolerances. See § 556.150 of (2) Limitations. As in paragraph this chapter. (d)(5)(ii)(A)(2) of this section. (d) Conditions of use in calves—(1) (iii) Swine—(A) Amount. 10 mg/lb body Amount. One 250 milligram bolus per 50 weight daily, for 3 to 5 days. pounds of body weight twice a day for (B) Indications for use. Control and 3 to 5 days. treatment of bacterial enteritis (i) Indications for use. Treatment of (scours) caused by E. coli and Sal- bacterial enteritis (scours) caused by monella spp., and bacterial pneumonia Escherichia coli and bacterial pneu- associated with Pasteurella spp., A. monia associated with Pasteurella spp., pleuropneumoniae, and Klebsiella spp. Klesbsiella spp., and Haemophilus spp. susceptible to chlortetracycline. (ii) Limitations. Administer bolus di- (C) Limitations. Prepare fresh solution rectly by mouth or crush and dissolve daily; use as the sole source of chlor- in milk or water for drenching or buck- tetracycline; do not use for more than et feeding; if no improvement is noted 5 days; do not administer to swine after 3 days of treatment, consult a within 24 hours of slaughter. Federal veterinarian; do not use for more than law restricts this drug to use by or on 5 days; do not administer within 24 the order of a licensed veterinarian. hours of slaughter.

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(2) Amount. One 25 milligram tablet (2) Indications for use. For the preven- for each 5 pounds of body weight every tion and treatment of bacterial enter- 12 hours daily for 3 to 5 days. itis; as an aid in the reduction of the (i) Indications for use. Control and incidence of cervical abscesses; and as treatment of bacterial enteritis an aid in the maintenance of weight (scours) caused by E. coli and Sal- gains in the presence of bacterial en- monella spp. and bacterial pneumonia teritis and atrophic rhinitis. associated with Pasteurella spp., (3) Limitations. Use as the sole source Haemophilus spp., and Klebsiella spp., of chlortetracycline and sulfonamide. susceptible to chlortetracycline. Not to be used for more than 28 con- (ii) Limitations. Administer tablet di- secutive days. Withdraw 15 days before rectly by mouth or crush and dissolve slaughter. Federal law restricts this in water for drenching; if no improve- drug to use by or on the order of a li- ment is noted after 3 days of treat- censed veterinarian. ment, consult a veterinarian; do not [76 FR 49649, Aug. 11, 2011, as amended at 81 use for more than 5 days; when feeding FR 17607, Mar. 30, 2016; 81 FR 94989, Dec. 27, milk or milk replacer, administration 1 2016] hour before or 2 hours after feeding; do not administer within 24 hours of § 520.446 Clindamycin capsules and slaughter. tablets. (3) Amount. One 500 milligram bolus (a) Specifications. (1) Each capsule per 100 pounds of body weight twice a contains the equivalent of 25, 75, 150, or day for 3 to 5 days. 300 milligrams (mg) clindamycin as the (i) Indications for use. Treatment of hydrochloride salt. bacterial enteritis (scours) caused by E. (2) Each tablet contains the equiva- coli and Salmonella spp., and bacterial lent of 25, 75, or 150 mg clindamycin as pneumonia associated with Pasteurella the hydrochloride salt. spp., Haemophilus spp., and Klebsiella (3) Each capsule contains the equiva- spp., susceptible to chlortetracycline. lent of 25, 75, or 150 mg clindamycin as (ii) Limitations. Administer directly the hydrochloride salt. by mouth or crush and dissolve in (b) Sponsors. See sponsors in water for drenching; if no improvement § 510.600(c) of this chapter as follows: is noted after 3 days of treatment, con- (1) Nos. 054771 and 069043 for use of sult a veterinarian; do not use for more capsules described in paragraph (a)(1) than 5 days; do not administer within of this section. 24 hours of slaughter. (2) No. 051311 for use of tablets described in paragraph (a)(2) of this sec- [57 FR 37325, Aug. 18, 1992, as amended at 67 tion. FR 78355, Dec. 24, 2002. Redesignated and (3) No. 043806 for use of tablets de- amended at 76 FR 49649, Aug. 11, 2011; 78 FR scribed in paragraph (a)(3) of this sec- 21059, Apr. 9, 2013; 81 FR 17607, Mar. 30, 2016] tion. (c) Conditions of use in dogs—(1) § 520.445 Chlortetracycline and sulfamethazine powder. Amount. Wounds, abscesses, and dental infections: 2.5 to 15 mg per pound (/lb) (a) Specifications. Each pound of solu- body weight every 12 hours for a max- ble powder contains chlortetracycline imum of 28 days. Osteomyelitis: 5.0 to bisulfate equivalent to 102.4 grams (g) 15 mg/lb body weight every 12 hours for of chlortetracycline hydrochloride and a minimum of 28 days. sulfamethazine bisulfate equivalent to (2) Indications for use. For the treat- 102.4 g of sulfamethazine. ment of skin infections (wounds and (b) Sponsor. See No. 016592 in abscesses) due to susceptible strains of § 510.600(c) of this chapter. coagulase-positive staphylococci (c) Related tolerances. See §§ 556.150 (Staphylococcus aureus or S. and 556.670 of this chapter. intermedius), deep wounds and abscesses (d) Conditions of use in swine. Admin- due to susceptible strains of Bacteroides ister in drinking water as follows: fragilis, Prevotella melaninogenicus, (1) Amount. 250 milligrams (mg) of Fusobacterium necrophorum, and Clos- chlortetracycline and 250 mg of tridium perfringens, dental infections sulfamethazine per gallon. due to susceptible strains of S. aureus,

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B. fragilis, P. melaninogenicus, F. scesses due to susceptible strains of necrophorum, and C. perfringens, and os- Clostridium perfringens and Bacteroides teomyelitis due to susceptible strains fragilis; and dental infections due to of S. aureus, B. fragilis, P. susceptible strains of S. aureus, S. melaninogenicus, F. necrophorum, and C. intermedius, Streptococcus spp., C. perfringens. perfringens, and B. fragilis. (3) Limitations. Federal law restricts [67 FR 54954, Aug. 27, 2002, as amended at 67 this drug to use by or on the order of a FR 78684, Dec. 26, 2002; 68 FR 55824, Sept. 29, licensed veterinarian. 2003; 69 FR 31734, June 7, 2004; 71 FR 39543, [67 FR 54954, Aug. 27, 2002, as amended at 68 July 13, 2006; 72 FR 19796, Apr. 20, 2007; 78 FR FR 55824, Sept. 29, 2003; 69 FR 32273, June 9, 17596, Mar. 22, 2013; 78 FR 30197, May 22, 2013; 2004; 71 FR 39204, July 12, 2006; 73 FR 4077, 79 FR 28819, May 20, 2014; 81 FR 17607, Mar. 30, Jan. 24, 2008; 78 FR 17596, Mar. 22, 2013; 79 FR 2016] 28819, May 20, 2014; 80 FR 76386, Dec. 9, 2015; 81 FR 17607, Mar. 30, 2016] § 520.452 Clenbuterol syrup. (a) Specifications. Each milliliter con- § 520.447 Clindamycin solution. tains 72.5 micrograms of clenbuterol (a) Specifications. Each milliliter of hydrochloride. solution contains the equivalent of 25 (b) Sponsor. See 000010 in § 510.600(c) of milligrams (mg) clindamycin as the this chapter. hydrochloride salt. (c) [Reserved] (b) Sponsors. See Nos. 051311, 054771, (d) Conditions of use—(1) Horses—(i) 058829, 061623, and 069043 in § 510.600(c) of Amount. Administer orally twice a day this chapter. (b.i.d.). Initial dose is 0.5 milliliter per (c) Special considerations. Federal law 100 pounds body weight (0.8 micrograms restricts this drug to use by or on the per kilogram) for 3 days (6 treatments). order of a licensed veterinarian. If no improvement, administer 1 milli- (d) Conditions of use—(1) Dogs—(i) liter per 100 pounds (1.6 micrograms per Amount. Wounds, abscesses, and dental kilogram) for 3 days (6 treatments). If infections: 2.5 to 15 mg per pound (/lb) no improvement, administer 1.5 milli- body weight every 12 hours for a max- liters per 100 pounds (2.4 micrograms imum of 28 days. Osteomyelitis: 5.0 to per kilogram) for 3 days (6 treatments). 15 mg/lb body weight every 12 hours for If no improvement, administer 2.0 mil- a minimum of 28 days. liliters per 100 pounds (3.2 micrograms (ii) Indications for use. For the treat- per kilogram) for 3 days (6 treatments). ment of skin infections (wounds and If no improvement, horse is non- abscesses) due to susceptible strains of responder to clenbuterol and treatment coagulase-positive staphylococci should be discontinued. (Staphylococcus aureus or S. (ii) Indications for use. Indicated for intermedius), deep wounds and abscesses the management of horses affected due to susceptible strains of Bacteroides with airway obstruction, such as oc- fragilis, Prevotella melaninogenicus, curs in chronic obstructive pulmonary Fusobacterium necrophorum, and Clos- disease (COPD). tridium perfringens; dental infections (iii) Limitations. Treat at effective due to susceptible strains of S. aureus, dose for 30 days. At the end of the 30- B. fragilis, P. melaninogenicus, F. day treatment period, drug should be necrophorum, and C. perfringens; and os- withdrawn. If signs return, the 30-day teomyelitis due to susceptible strains treatment period may be repeated. If of S. aureus, B. fragilis, P. repeating treatment, the step-wise dos- melaninogenicus, F. necrophorum, and C. age schedule should be repeated. The perfringens. effect of this drug on breeding stallions (2) Cats—(i) Amount. 5.0 to 15.0 mg/lb and brood mares has not been deter- body weight every 24 hours for a max- mined. Treatment starting with dos- imum of 14 days. ages higher than the initial dose is not (ii) Indications for use. For the treat- recommended. Federal law prohibits ment of skin infections (wounds and the extralabel use of this drug in food abscesses) due to susceptible strains of animals. Federal law restricts this Staphylococcus aureus, S. intermedius, drug to use by or on the order of a li- Streptococcus spp.; deep wounds and ab- censed veterinarian.

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(2) [Reserved] (2) Each milliliter of cyclosporine oral solution, USP (MODIFIED) con- [63 FR 41419, Aug. 4, 1998] tains 100 mg cyclosporine. § 520.455 Clomipramine tablets. (b) Sponsor. See No. 058198 in (a) Specifications. Each tablet con- § 510.600(c) of this chapter. tains 5, 20, 40, or 80 milligrams (mg) (c) [Reserved] clomipramine hydrochloride. (d) Conditions of use—(1) Dogs. Use (b) Sponsor. See No. 058198 in capsules described in paragraph (a)(1) § 510.600(c) of this chapter. of this section as follow: (c) Conditions of use—(1) Amount. 2 to (i) Amount. Administer 5 mg per kilo- 4 milligrams of clomipramine hydro- gram (mg/kg) of body weight given chloride per kilogram (0.9 to 1.8 milli- orally as a single daily dose for 30 days. grams per pound) of body weight per Following this initial daily treatment day, administered as a single daily dose period, the dosage may be tapered by or divided twice daily. decreasing the frequency of adminis- (2) Indications for use. For use as part tration to every other day or two times of a comprehensive behavioral manage- a week, until a minimum frequency is ment program to treat separation anx- reached which will maintain the de- iety in dogs greater than 6 months of sired therapeutic effect. age. (ii) Indications for use. For the control (3) Limitations. Federal law restricts of atopic dermatitis in dogs weighing this drug to use by or on the order of a at least 4 pounds. licensed veterinarian. (iii) Limitations. Federal law restricts this drug to use by or on the order of a [64 FR 1762, Jan. 12, 1999, as amended at 72 FR 262, Jan. 4, 2007] licensed veterinarian. (2) Cats. Use the solution described in § 520.462 Clorsulon drench. paragraph (a)(2) of this section as fol- (a) Specifications. The drug is a sus- low: pension containing 8.5 percent (i) Amount. Administer 7 mg/kg of clorsulon (85 milligrams per milliliter). body weight orally as a single daily (b) Sponsor. See No. 050604 in dose for a minimum of 4 to 6 weeks or § 510.600(c) of this chapter. until resolution of clinical signs. Fol- (c) Conditions of use. Cattle—(1) lowing this initial daily treatment pe- Amount. One-quarter fluid ounce per 200 riod, the dosage may be tapered by de- pounds of body weight (7 milligrams creasing the frequency of administra- per kilogram or 3.2 milligrams per tion to every other day or twice weekly pound of body weight). to maintain the desired therapeutic ef- (2) Indications for use. For the treat- fect. ment of immature and adult liver fluke (ii) Indications for use. For the control (Fasciola hepatica) infestations in cat- of feline allergic dermatitis in cats at tle. least 6 months of age and weighing at (3) Limitations. Using dose syringe, least 3 pounds. deposit drench over back of tongue. Do (iii) Limitations. Federal law restricts not treat cattle within 8 days of this drug to use by or on the order of a slaughter. Because a withdrawal time licensed veterinarian. in milk has not been established, do [68 FR 54804, Sept. 19, 2003, as amended at 76 not use in female dairy cattle of breed- FR 78815, Dec. 20, 2011] ing age. Consult your veterinarian for assistance in the diagnosis, treatment, § 520.530 Cythioate oral liquid. and control of parasitism. (a) Specifications. Each milliliter con- [50 FR 10221, Mar. 14, 1985, as amended at 62 tains 15 milligrams of cythioate. FR 63270, Nov. 28, 1997] (b) Sponsor. See Nos. 000859 and 054771 in § 510.600 of this chapter. § 520.522 Cyclosporine. (c) Special considerations. Cythioate is (a) Specifications. (1) Each a cholinesterase inhibitor. Do not use cyclosporine capsule, USP (MODIFIED) this product in animals simultaneously contains 10, 25, 50, or 100 milligrams with or within a few days before or (mg) cyclosporine. after treatment with or exposure to

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cholinesterase-inhibiting drugs, insec- pounds body weight daily (0.5 milli- ticides, pesticides, or chemicals. gram per kilogram) for at least 28 days. (d) Conditions of use—(1) Amount. 15 [64 FR 10103, Mar. 2, 1999, as amended at 64 milligrams cythioate per 10 pounds of FR 30386, June 8, 1999; 79 FR 28819, May 20, body weight every third day or twice a 2014] week. (2) Indications for use. Dogs, for con- § 520.538 Deracoxib. trol of fleas. (a) Specifications. Each tablet con- (3) Limitations. Federal law restricts tains 12, 25, 50, 75, or 100 milligrams this drug to use by or on the order of a (mg) deracoxib. licensed veterinarian. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. [49 FR 5614, Feb. 14, 1984, as amended at 67 FR 78355, Dec. 24, 2002; 79 FR 28819, May 20, (c) [Reserved] 2014] (d) Conditions of use in dogs—(1) Amount. Administer orally as needed, § 520.531 Cythioate tablets. as a single daily dose based on body weight: (a) Specifications. Each tablet con- (i) 1 to 2 mg/kilogram (kg) (0.45 to tains 30 or 90 milligrams (mg) 0.91 mg/pound (lb)), for use as in para- cythioate. graph (d)(2)(i) of this section. (b) Sponsors. See sponsor numbers in (ii) 1 to 2 mg/kg (0.45 to 0.91 mg/lb) for § 510.600(c) of this chapter as follows: 3 days, for use as in paragraph (d)(2)(ii) (1) No. 000859 for use of 30- and 90-mg of this section. tablets; (iii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for (2) No. 054771 for use of the 30-mg tab- up to 7 days, for use as in paragraph let. (d)(2)(iii) of this section. (c) Conditions of use—(1) Amount. 30 (2) Indications for use. (i) For the con- milligrams cythioate per 20 pounds of trol of pain and inflammation associ- body weight every third day or twice a ated with osteoarthritis. week. (ii) For the control of postoperative (2) Indications for use. Dogs, for con- pain and inflammation associated with trol of fleas. dental surgery. (3) Limitations. Federal law restricts (iii) For the control of postoperative this drug to use by or on the order of a pain and inflammation associated with licensed veterinarian. orthopedic surgery. (3) Limitations. Federal law restricts [49 FR 5615, Feb. 14, 1984, as amended at 59 FR 26942, May 25, 1994; 67 FR 78355, Dec. 24, this drug to use by or on the order of a 2002; 79 FR 28819, May 20, 2014] licensed veterinarian. [67 FR 68760, Nov. 13, 2002, as amended at 68 § 520.534 Decoquinate. FR 18882, Apr. 17, 2003; 72 FR 37437, July 10, (a) Specifications. Each gram of pow- 2007; 73 FR 33692, June 13, 2008; 77 FR 3928, der contains 8 milligrams (0.8 percent) Jan. 26, 2012] decoquinate. § 520.540 Dexamethasone oral dosage (b) Sponsor. See No. 054771 in forms. § 510.600(c) of this chapter. (c) Related tolerances. See § 556.170 of § 520.540a Dexamethasone powder. this chapter. (a) Specifications. Each packet con- (d) Conditions of use. Calves—(1) tains 10 milligrams (mg) of dexametha- Amount. Feed 22.7 milligrams per 100 sone. pounds of body weight (0.5 milligram (b) Sponsor. See No. 000061 in per kilogram) per day. § 510.600(c) of this chapter. (2) Indications for use. For the preven- (c) Conditions of use in cattle and tion of coccidiosis in ruminating and horses—(1) Amount. Administer 5 to 10 nonruminating calves, including veal mg per animal the first day then 5 mg calves, caused by Eimeria bovis and E. per day as required by drench or by zuernii. sprinkling on a small amount of feed. (3) Limitations. Feed in whole milk at (2) Indications for use. As supportive the rate of 22.7 milligrams per 100 therapy following parenteral steroid

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administration for management or in- (iii) Limitations. Federal law restricts flammatory conditions such as acute this drug to use by or on the order of a arthritic lameness, and for various licensed veterinarian. stress conditions where corticosteroids [40 FR 26273, June 23, 1975, as amended at 44 are required while the animal is being FR 7130, Feb. 6, 1979; 50 FR 49372, Dec. 2, 1985; treated for a specific condition. 52 FR 7832, Mar. 13, 1987; 55 FR 8461, Mar. 8, (3) Limitations. Federal law restricts 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. this drug to use by or on the order of a 31, 2003; 70 FR 16934, Apr. 4, 2005; 79 FR 28819, licensed veterinarian. A withdrawal pe- May 20, 2014] riod has not been established for this product in preruminating calves. Do § 520.540c Dexamethasone chewable not use in calves to be processed for tablets. veal. Do not use in horses intended for (a) Specifications. Each half-scored human consumption. tablet contains 0.25 milligram of dexamethasone. [79 FR 28819, May 20, 2014] (b) Sponsor. See No. 051031 in § 520.540b Dexamethasone tablets and § 510.600(c) of this chapter. boluses. (c) Conditions of use in dogs—(1) Amount. Administer by free-choice (a)(1) Specifications. Each bolus is feeding or crumbled over food 0.25 to half-scored and contains 10 milligrams 1.25 milligrams daily in single or two of dexamethasone. divided doses until response is noted or (2) Sponsor. See No. 000061 in 7 days have elapsed. When response is § 510.600(c) of this chapter. attained, dosage should be gradually (3) Conditions of use in cattle and reduced by 0.125 milligram per day horses—(i) Amount. Administer orally 5 until maintenance level is achieved. to 10 milligrams on the first day, then (2) Indications for use. As supportive 5 milligrams per day as required. therapy in nonspecific dermatosis and (ii) Indications for use. As supportive inflammatory conditions. therapy following parenteral steroid (3) Limitations. Federal law restricts administration for management or in- this drug to use by or on the order of a flammatory conditions such as acute licensed veterinarian. arthritic lameness, and for various stress conditions where corticosteroids [44 FR 7130, Feb. 6, 1979, as amended at 56 FR are required while the animal is being 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 treated for a specific condition. FR 28820, May 20, 2014; 82 FR 11508, Feb. 24, (iii) Limitations. Federal law restricts 2017] this drug to use by or on the order of a § 520.563 Dexamethasone chewable licensed veterinarian. A withdrawal pe- tablets. riod has not been established for this product in preruminating calves. Do (a) Specifications. Diatrizoate not use in calves to be processed for meglumine oral solution is a water veal. Do not use in horses intended for soluble radiopaque medium containing human consumption. 66 percent diatrizoate meglumine and 10 percent diatrizoate sodium. (b)(1) Specifications. Each tablet contains 0.25 milligram of dexamethasone. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (2) Sponsors. See Nos. 000061 and 061623 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (1) Amount. Administer orally 0.5 to 1.0 (3) Conditions of use in dogs and cats— milliliter per pound of body weight by (i) Amount. Dogs: Administer orally 0.25 gavage or stomach tube. Administered to 1.25 milligrams per day for up to 7 rectally 0.5 to 1.0 milliliter per pound days. Cats: Administer orally 0.125 to of body weight diluted with 1 part of 0.5 milligrams per day for up to 7 days. the drug to 5 parts of water. (ii) Indications for use. As an anti-in- (2) For radiog- flammatory agent. Indications for use. raphy of the gastrointestinal tract.

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(3) Limitations. Federal law restricts (c) Required statement. Consult your this drug to use by or on the order of a veterinarian for assistance in the diag- licensed veterinarian. nosis, treatment, and control of parasitism, and before administering to [44 FR 12993, Mar. 9, 1979, as amended at 50 FR 41489, Oct. 11, 1985; 79 FR 28820, May 20, weak or debilitated animals. 2014] (d) Conditions of use. Dogs—(1) Amount. Single dose of 1 tablet (1 gram § 520.580 Dichlorophene and toluene. of dichlorophene) for each 10 pounds of (a) Specifications. Each capsule con- body weight. tains 50 milligrams (mg) of (2) Indications for use. It is used as an dichlorophene and 60 mg of toluene, or aid in the removal of tapeworms multiples thereof. (Taenia pisiformis and Dipylidium (b) Sponsors. See sponsors in caninum). § 510.600(c) of this chapter for use as in (3) Limitations. Withhold solid foods paragraph (c) of this section: and milk for at least 12 hours prior to (1) Nos. 017135, 023851, 051311, and medication and for 4 hours afterward. 058670 for use only as a single dose. [45 FR 10333, Feb. 15, 1980] (2) Nos. 000061 and 054771 for use in a single dose or divided-dosage regimen. § 520.600 Dichlorvos. (c) Required statement. Consult your (a) Chemical name. 2,2-Dichlorvinyl veterinarian for assistance in the diag- dimethyl phosphate. nosis, treatment, and control of para- (b) [Reserved] sitism, and before administering to (c) Sponsor. See No. 054628 in weak or debilitated animals. § 510.600(c) of this chapter. (d) Conditions of use—(1) Amount. Ad- (d) Related tolerances. See § 556.180 of minister as follows: this chapter. (i) Single dose: Administer 100 mg of (e) Conditions of use in swine. (1) It is dicholorophene and 120 mg of toluene recommended for the removal and con- per pound of body weight. trol of sexually mature (adult), sexu- (ii) Divided dose: Administer 100 mg ally immature and/or 4th stage larvae of dichlorophene and 120 mg of toluene of the whipworm (Trichuris suis), nod- per 5 pounds of body weight (20 and 24 ular worms (Oesophagostomum spp.), mg per pound) daily for 6 days. large round-worm (Ascaris suum), and (2) Indications for use. For the re- the mature thick stomach worm moval of ascarids (Toxocara canis and (Ascarops strongylina) occurring in the Toxascaris leonina) and hookworms lumen of the gastrointestinal tract of (Ancylostoma caninum and Uncinaria pigs, boars, and open or bred gilts and stenocephala); and as an aid in remov- sows. ing tapeworms (Taenia pisiformis, (2) The preparation should be added Dipylidium caninum, and Echinococcus to the indicated amount of feed as set granulosus) from dogs and cats. forth in paragraph (e)(2) of this section (3) Limitations. Withhold solid foods and administered shortly after mixing, and milk for at least 12 hours prior to as follows: medication and for 4 hours afterward. Repeat treatment in 2 to 4 weeks in Pounds of Pounds of feed to be mixed feed Number of animals subject to reinfection. Weight of ani- mixed with to be admin- pigs to be mal in pounds each 0.08 istered to treated per [45 FR 10332, Feb. 15, 1980] ounce of each pig as 0.08 ounce dichlorvos a single of dichlorvos EDITORIAL NOTE: For FEDERAL REGISTER ci- treatment tations affecting § 520.580, see the List of CFR 20–30 ...... 4 0.33 12 Sections Affected, which appears in the 31–40 ...... 5 0.56 9 Finding Aids section of the printed volume 41–60 ...... 6 1.00 6 and at www.fdsys.gov. 61–80 ...... 5 1.00 5 81–100 ...... 4 1.00 4 § 520.581 Dichlorophene tablets. Adult Gilts, Sows, and (a) Specifications. Each tablet con- Boars ...... 16 4.00 4 tains 1 gram of dichlorophene. (b) Sponsor. See 023851 in § 510.600(c) of (3) Do not use this product on ani- this chapter. mals either simultaneously or within a

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few days before or after treatment with esterase-inhibiting drugs, pesticides, or or exposure to cholinesterase inhib- chemicals. iting drugs, pesticides, or chemicals. (7) Federal law restricts this drug to The preparation should be mixed thor- use by or on the order of a licensed vet- oughly with the feed on a clean, imper- erinarian. vious surface. Do not allow swine ac- (g) Conditions of use in horses when ad- cess to feed other than that containing ministered in grain. (1) It is rec- the preparation until treatment is ommended for the removal and control complete. Do not treat pigs with signs of bots (Gastrophilus intestinalis, G. na- of scours until these signs subside or salis), large strongyles (Strongylus are alleviated by proper medication. vulgaris, S. equinus, S. edentatus), small Resume normal feeding schedule after- strongyles (of the genera wards. Swine may be retreated in 4 to Cyathostomum, Cylicocercus, 5 weeks. Cylicocyclus, Cylicodontophorus, (f) Conditions of use in dogs. (1) For re- Triodontophorus, Poteriostomum, moval of Toxocara canis and Toxascaris Gyalocephalus), pinworms (Oxyuris leonina (roundworms), Ancylostoma equi), and large roundworm (Parascaris caninum and Uncinaria stenocephala equorum) in horses including ponies and (hookworms), and Trichuris vulpis mules. Not for use in foals (sucklings (whipworm) residing in the lumen of and young weanlings). the gastrointestinal tract. (2) For a satisfactory diagnosis, a mi- (2) The drug is in capsule form for di- croscopic fecal examination should be rect administration and in pellet form performed by a veterinarian or a diag- for administration in about one-third nostic laboratory prior to worming. of the regular canned dog food ration (3) It is administered in the grain or in ground meat. Dogs may be treat- portion of the ration at a dosage of 14.2 ed with any combination of capsules milligrams to 18.5 milligrams per and/or pellets so that the animal re- pound of body weight as a single dose. ceives a single dose equaling 12 to 15 It may be administered at one-half of milligrams of the active ingredient per the single recommended dosage and re- pound of body weight. One-half of the peated 8 to 12 hours later in the treat- single recommended dosage may be ment of very aged, emaciated or debili- given, and the other half may be ad- tated subjects or those reluctant to ministered 8 to 24 hours later. This consume medicated feed. In suspected split dosage schedule should be used in cases of severe ascarid infection suffi- animals which are very old, heavily cient to cause concern over mechanical parasitized, anemic, or otherwise de- blockage of the intestinal tract, the bilitated. The drug should not be used split dosage should be utilized. in dogs weighing less than 2 pounds. (4) Do not use in horses which are se- (3) In some dogs, efficacy against verely debilitated, suffering from diar- Trichurias vulpis (whipworm) may be er- rhea or severe constipation, infectious ratic. Dogs that do not develop a nega- disease, toxemia or colic. Do not ad- tive stool for Trichuris vulpis ova 10 to minister in conjunction with or within 14 days following initial treatment 1 week of administration of muscle re- should be re-treated. If a negative stool laxant drugs, phenothiazine derived is not obtained in 10 to 14 days fol- tranquilizers or central nervous system lowing re-treatment, alternate means depressant drugs. Horses should not be of therapy should be considered. subjected to insecticide treatment for 5 (4) Do not use in dogs infected with days prior to or after treating with the Dirofilaria immitis. drug. Do not administer to horses af- (5) Do not use with other flicted with chronic alveolar emphy- anthelmintics, taeniacides, antifilarial sema (heaves) or related respiratory agents, muscle relaxants, or tranquil- conditions. The product is a cholin- izers. esterase inhibitor and should not be (6) The drug is a cholinesterase inhib- used simultaneously or within a few itor. Not for use simultaneously or days before or after treatment with or within a few days before or after treat- exposure to cholinesterase inhibiting ment with or exposure to cholin- drugs, pesticides or chemicals.

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(5) Do not use in animals other than (Toxocara canis and Toxascaris leonina) horses, ponies, and mules. Do not use and hookworms (Ancylostoma caninum in horses, ponies, and mules intended and Uncinaria stenocephala). for food purposes. Do not allow fowl ac- (4) Cats and kittens: Removal and cess to feed containing this preparation control of intestinal roundworms or to fecal excrement from treated ani- (Toxocara cati and Toxascaris leonina) mals. and hookworms (Ancylostoma (h) Conditions of use in horses when tubaeforme and Uncinaria stenocephala). administered orally by syringe. (1) It is (5) Dichlorvos is a cholinesterase in- recommended for the removal and con- hibitor. Do not use simultaneously trol of first, second, and third instar with or within a few days before or bots (Gastrophilus intestinalis and G. na- after treatment with or exposure to salis), sexually mature and sexually im- cholinesterase-inhibiting drugs, pes- mature (4th stage) ascarids (Parascaris ticides, or chemicals. equorum) in horses and foals. (6) Do not use in animals under 10 (2) The product is in the form of a gel days of age or 1 pound of body weight. which is administered directly from a (7) Do not administer to animals syringe onto the horse’s tongue. The showing signs of constipation, mechan- product is administered at a dosage ical blockage of the intestinal tract, level of 20 milligrams of dichlorvos per impaired liver function, or recently ex- kilogram of body weight for the re- posed to or showing signs of infectious moval of bots and ascarids. The same disease. dosage level is repeated every 21 to 28 (8) Do not use in dogs or puppies in- days for the control of bots and fected with Dirofilaria immitis. ascarids. For the control of bots only, (9) Federal law restricts this drug to the repeat dosage is 10 milligrams per use by or on the order of a licensed vet- kilogram of body weight every 21 to 28 erinarian. days during bot fly season. [40 FR 13838, Mar. 27, 1975, as amended at 48 (3) Do not use this product in animals FR 40704, Sept. 9, 1983; 51 FR 28546, Aug. 8, simultaneously or within a few days 1986; 62 FR 35076, June 30, 1997; 64 FR 18571, before or after treatment with or expo- Apr. 15, 1999; 78 FR 21059, Apr. 9, 2013] sure to cholinesterase-inhibiting drugs, § 520.606 Diclazuril. pesticides or chemicals. Do not administer in conjunction with or within 1 (a) Specifications. Each 100 grams (g) week of administration of muscle-re- of pellets contain 1.56 g diclazuril. laxant drugs, phenothiazine derived (b) Sponsor. See No. 000061 in tranquilizers, or central nervous sys- § 510.600(c) of this chapter. tem depressants. (c) Conditions of use in horses—(1) (4) Do not use in horses which are Amount. Administer 1 milligram (mg) severly debilitated or suffering from di- per kilogram (0.45 mg per pound) of arrhea or severe constipation, infec- body weight in the daily grain ration tious disease, toxemia, or colic. Do not for 28 days. administer to horses affected with (2) Indications for use. For the treat- chronic alveolar emphysema (heaves) ment of equine protozoal or other respiratory conditions. myeloencephalitis (EPM) caused by (5) Do not use in horses intended for Sarcocystis neurona. food purposes. (3) Limitations. Do not use in horses (6) Federal law restricts this drug to intended for human consumption. Fed- eral law restricts this drug to use by or use by or on the order of a licensed vet- on the order of a licensed veterinarian. erinarian. (i) Conditions of use in dogs, cats, pup- [72 FR 20943, Apr. 27, 2007] pies, and kittens. (1) Each tablet contains 2, 5, 10, or 20 milligrams of § 520.608 Dicloxacillin. dichlorvos. (a) Specifications. Each capsule con- (2) It is administered orally at 5 mil- tains dicloxacillin sodium ligrams of dichlorvos per pound of body monohydrate equivalent to 50, 100, 200, weight. or 500 milligrams of dicloxacillin. (3) Dogs and puppies: Removal and (b) Sponsor. See No. 054771 in § 510.600 control of intestinal roundworms (c) of this chapter.

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(c) Conditions of use in dogs—(1) (ii) Three milligrams per pound of Amount. Administer orally 5 to 10 milli- body weight daily as an aid in the con- grams per pound of body weight, three trol of ascarid infections (Toxocara times daily. In severe cases, up to 25 canis) in dogs. milligrams per pound of body weight (iii) Twenty-five to 50 milligrams per three times daily. pound of body weight as an aid in the (2) Indications for use. For the treat- treatment of ascarid infections in dogs ment of pyoderma (pyogenic derma- (Toxocara canis) and cats (Toxocara titis) due to penicillinase-producing canis and Toxascaris leonina). staphylococci sensitive to (2) Limitations. Federal law restricts dicloxacillin. this drug to use by or on the order of a (3) Limitations. Federal law restricts licensed veterinarian. this drug to use by or on the order of a licensed veterinarian. [46 FR 23230, Apr. 24, 1981, as amended at 46 FR 41038, Aug. 14, 1981; 46 FR 46315, Sept. 18, [57 FR 37325, Aug. 18, 1992, as amended at 79 1981; 46 FR 61653, Dec. 18, 1981; 47 FR 10805, FR 28820, May 20, 2014] Mar. 12, 1982; 47 FR 14150, Apr. 2, 1982; 50 FR 41489, Oct. 11, 1985; 50 FR 49372, Dec. 2, 1985; § 520.620 Diethylcarbamazine oral dos- 53 FR 40056, Oct. 13, 1988; 53 FR 40727, Oct. 18, age forms. 1988; 55 FR 8461, Mar. 8, 1990; 61 FR 34728, July 3, 1996; 62 FR 35076, June 30, 1997; 66 FR § 520.622 Diethylcarbamazine citrate 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 76 oral dosage forms. FR 17777, Mar. 31, 2011; 77 FR 4896, Feb. 1, 2012; 78 FR 21059, Apr. 7, 2013; 79 FR 28820, § 520.622a Diethylcarbamazine citrate May 20, 2014] tablets. (a) Sponsors. (1) [Reserved] § 520.622b Diethylcarbamazine citrate (2) See 054771 in § 510.600(c) of this syrup. chapter for use of 100, 200, and 300 milli- (a)(1) Specifications. Each milliliter of gram tablets for prevention of heart- syrup contains 60 milligrams of worm disease in dogs and as an aid in diethylcarbamazine citrate. the treatment of ascarid infections in (2) Sponsor. See No. 054771 in dogs. § 510.600(c) of this chapter. (3) See 061623 in § 510.600(c) of this (3) Conditions of use. (i) The drug is chapter for use of 50, 100, 200, 300, or 400 indicated for use in dogs for the pre- milligram tablets for prevention of vention of infection with Dirofilaria heartworm disease in dogs, as an aid in immitis and T. canis and T. leonina. It is the control of ascarid infections in also indicated for treatment of ascarid dogs, and as an aid in the treatment of ascarid infections in dogs and cats. infections of T. canis and T. leonina in (4) [Reserved] dogs and T. cati in cats. (5) See No. 000061 in § 510.600(c) of this (ii) For prevention of heartworm and chapter for use of 60, 120, or 180 milli- ascarid infections in dogs, the drug gram tablets for prevention of heart- may be added to the daily diet at a dos- worm disease in dogs, as an aid in the age rate of 3.0 milligrams per pound of control of ascarid infections in dogs, body weight per day or given directly and as an aid in the treatment of asca- by mouth at the same dosage rate. For rid infections in dogs and cats. treatment of ascarid infections in dogs (6) See No. 054628 in § 510.600(c) of this and cats, the drug is administered at a chapter for use of 50, 100, 200, 300, or 400 dosage level of 25 to 50 milligrams per milligram tablets for prevention of pound of body weight preferably ad- heartworm disease in dogs, as an aid in ministered immediately after feeding. the control of ascarid infections in (iii) Older dogs should be proven neg- dogs, and as an aid in the treatment of ative for the presence of Dirofilaria ascarid infections in dogs and cats. immitis infection before administration (b) Conditions of use—(1) Dosage/indi- of the drug. Those with proven infec- cations for use. (i) Three milligrams per tion of Dirofilaria immitis should be ren- pound of body weight daily for preven- dered negative using adulticidal and tion of heartworm disease (Dirofilaria microfilaricidal drugs before adminis- immitis) in dogs. tration of this drug.

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(iv) Federal law restricts this drug to (3) For 061690, use of 45 or 150 milli- use by or on the order of a licensed vet- gram tablets as in paragraph (c)(2)(iii) erinarian. of this section. (b) [Reserved] (4) For 061133, use of 60-, 120-, or 180- (c)(1) Specifications. Each milliliter of milligram tablets as in paragraph syrup contains 60 milligrams of (c)(2)(i) of this section. diethylcarbamazine citrate. (5) For 000061, use of 60-milligram (2) Sponsor. See No. 054628 in tablets as in paragraph (c)(2)(i) of this § 510.600(c) of this chapter. section. (3) Conditions of use. (i) The drug is (6) For 054628, use of 30, 60, 120, or 180 used in dogs between 4 weeks and 8 milligram tablets as in paragraph months of age for the removal of (c)(2)(i) of this section. ascarids (Toxacara canis) and in ani- (c) Conditions of use—(1) Amount. 3 mals over 4 weeks of age for the pre- milligrams per pound of body weight vention of heartworm disease per day for prevention of heartworm (Dirofilaria immitis). disease and control of ascarids; 25 to 50 (ii) The drug is administered (a) for milligrams per pound of body weight as removal of ascarids at a dosage of 50 an aid in treatment of ascarid infec- milligrams per pound of body weight tions. divided into two equal doses and ad- (2) Indications for use. (i) For preven- ministered 8 to 12 hours apart (morning tion of heartworm disease (Dirofilaria and night), orally or mixed with either immitis) in dogs; as an aid in control of dry or wet food, and (b) for prevention ascarids (Toxocara canis) in dogs; as an of heartworm disease at a dosage of 3 aid in treatment of ascarid (Toxocara milligrams per pound of body weight canis and Toxascaris leonina) infections daily, orally or in food, in heartworm in dogs and cats. endemic areas, from the beginning of (ii) For prevention of infection with mosquito activity, during the mosquito Dirofilaria immitis (heartworm disease) season, and for 2 months following the in dogs; as an aid in treatment of asca- end thereof. rid (Toxocara canis and Toxascaris (iii) Dogs older than 8 months of age leonina) infections in dogs. may be infected with Dirofilaria immitis. (iii) For prevention of heartworm dis- Use of the drug is contraindicated in ease (Dirofilaria immitis) in dogs. dogs with active D. immitis infections. (3) Limitations. Federal law restricts (iv) Federal law restricts this drug to this drug to use by or on the order of a use by or on the order of a licensed vet- licensed veterinarian. erinarian. [43 FR 6941, Feb. 17, 1978] [40 FR 13838, Mar. 27, 1975, as amended at 41 FR 28265, July 9, 1976; 44 FR 3967, Jan. 19, EDITORIAL NOTE: For FEDERAL REGISTER ci- 1979; 47 FR 14150, Apr. 2, 1982; 47 FR 35186, tations affecting § 520.622c, see the List of Aug. 13, 1982; 49 FR 33997, Aug. 28, 1984; 50 FR CFR Sections Affected, which appears in the 41489, Oct. 11, 1985; 53 FR 47027, Oct. 18, 1988; Finding Aids section of the printed volume 61 FR 34728, July 3, 1996; 62 FR 35076, June 30, and at www.fdsys.gov. 1997; 62 FR 38906, July 21, 1997; 77 FR 4897, Feb. 1, 2012; 78 FR 21059, Apr. 9, 2013; 79 FR § 520.623 Diethylcarbamazine and 28820, May 20, 2014] oxibendazole chewable tablets. (a) Specifications. Each tablet con- § 520.622c Diethylcarbamazine citrate tains either 60, 120, or 180 milligrams of chewable tablets. diethylcarbamazine citrate with 45, 91, (a) Specifications. Each chewable tab- or 136 milligrams of oxibendazole, re- let contains 30, 45, 60, 120, 150, or 180 spectively. milligrams of diethylcarbamazine cit- (b) Sponsor. See No. 054771 in rate. § 510.600(c) of this chapter. (b) Sponsors. See drug listing nos. in (c) Conditions of use in dogs—(1) § 510.600(c) of this chapter for identi- Amount. Administer orally to dogs at a fication of sponsors as follows: dosage level of 6.6 milligrams of (1) [Reserved] diethylcarbamazine citrate per kilo- (2) For 054771, use of 60, 120, or 180 gram of body weight (3 milligrams per milligram tablets as in paragraph pound of body weight) and 5.0 milli- (c)(2)(ii) of this section. grams of oxibendazole per kilogram of

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body weight (2.27 milligrams per pound every month, as necessary, to maintain of body weight). a target percent weight loss until the (2) Indications for use. For prevention desired weight is achieved. of infection with Dirofilaria immitis (2) Indications for use. For the man- (heartworm disease) and Ancylostoma agement of obesity. caninum (hookworm infection) and for (3) Limitations. Federal law restricts removal and control of Trichuris vulpis this drug to use by or on the order of a (whipworm infection) and mature and licensed veterinarian. immature stages of intestinal Toxocara [72 FR 263, Jan. 4, 2007, as amended at 79 FR canis (ascarid infection). 28820, May 20, 2014] (3) Limitations. Federal law restricts this drug to use by or on the order of a § 520.763 Dithiazanine oral dosage licensed veterinarian. forms. [50 FR 28768, July 16, 1985, as amended at 53 § 520.763a Dithiazanine tablets. FR 45759, Nov. 14, 1988; 54 FR 3776, Jan. 26, 1989; 54 FR 6804, Feb. 14, 1989; 56 FR 50653, (a) Specifications. Each tablet con- Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR tains 10, 50, 100, or 200 milligrams (mg) 28820, May 20, 2014] dithiazanine iodide. (b) Sponsor. See No. 054628 in § 520.645 Difloxacin. § 510.600(c) of this chapter. (a) Specifications. Each tablet con- (c) Conditions of use in dogs—(1) Indi- tains 11.4, 45.4, or 136 milligrams (mg) cations for use and amount. Administer of difloxacin hydrochloride. orally immediately after feeding as fol- (b) Sponsor. See No. 000010 in lows: § 510.600(c) of this chapter. (i) For large roundworms (Toxocara (c) [Reserved] canis, Toxascaris leonina): 10 mg per (d) Conditions of use—(i) Amount. Ad- pound (/lb) of body weight for 3 to 5 minister 5 to 10 mg per kilogram (2.3 to days; 4.6 mg per pound) of body weight orally (ii) For hookworms (Ancylostoma once a day for 2 to 3 days beyond ces- caninum, Uncinaria stenocephala) and sation of clinical signs of disease up to whipworms (Trichuris vulpis): 10 mg/lb a maximum of 30 days. of body weight for 7 days; (ii) Indications for use. For manage- (iii) For Strongyloides (Strongyloides ment of diseases in dogs associated canis, Strongyloides stercoralis): 10 mg/lb with bacteria susceptible to difloxacin. of body weight for 10 to 12 days; (iii) Limitations. Federal law prohibits (iv) For heartworm microfilariae the extra-label use of this drug in food- (Dirofilaria immitus): 3 to 5 mg/lb of producing animals. Federal law re- body weight for 7 to 10 days. Treatment stricts this drug to use by or on the for heartworm microfilariae should fol- order of a licensed veterinarian. low 6 weeks after therapy for adult (2) [Reserved] worms. (2) Limitations. Federal law restricts [63 FR 8123, Feb. 18, 1998, as amended at 75 FR 10165, Mar. 5, 2010] this drug to use by or on the order of a licensed veterinarian. § 520.666 Dirlotapide. [79 FR 28820, May 20, 2014] (a) Specifications. Each milliliter (mL) of solution contains 5 milligrams § 520.763b Dithiazanine powder. (mg) dirlotapide. (a) Specifications. Each tablespoon of (b) Sponsor. See No. 054771 in powder contains 200 milligrams (mg) § 510.600(c) of this chapter. dithiazanine iodide. (c) Conditions of use in dogs—(1) (b) Sponsor. See No. 000010 in Amount. The initial dosage is 0.01 mL/ § 510.600(c) of this chapter. kg (0.0045 mL/lb) body weight for the (c) Conditions of use in dogs—(1) Indi- first 14 days. After the first 14 days of cations for use and amount. Administer treatment, the dose volume is doubled orally by mixing in food as follows: to 0.02 mL/kg (0.009 mL/lb) body weight (i) For large roundworms (Toxocara for the next 14 days (days 15 to 28 of canis, Toxascaris leonina): 10 mg per treatment). Dogs should be weighed pound (/lb) of body weight for 3 to 5 monthly and the dose volume adjusted days;

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(ii) For hookworms (Ancylostoma § 520.766 Domperidone. caninum, Uncinaria stenocephala) and (a) Specifications. Each milliliter of whipworms (Trichuris vulpis): 10 mg/lb gel contains 110 milligrams (mg) of body weight for 7 days; domperidone. (iii) For Strongyloides (Strongyloides (b) Sponsor. See No. 043264 in § 510.600 canis, Strongyloides stercoralis): 10 mg/lb of this chapter. of body weight for 10 to 12 days; (c) Conditions of use in horses—(1) (iv) For heartworm microfilariae Amount. Administer 0.5 mg per pound (Dirofilaria immitus): 3 to 5 mg/lb of (mg/lb) (1.1 mg/kilogram (kg)) by body weight for 7 to 10 days. Treatment mouth once daily starting 10 to 15 days for heartworm microfilariae should fol- prior to the expected foaling date. low 6 weeks after therapy for adult Treatment may be continued for up to worms. 5 days after foaling if mares are not (2) Limitations. Federal law restricts producing adequate milk. this drug to use by or on the order of a (2) Indications for use. For prevention licensed veterinarian. of fescue toxicosis in periparturient mares. [79 FR 28820, May 20, 2014] (3) Limitations. Do not use in horses intended for human consumption. Fed- § 520.763c Dithiazanine iodide and pi- eral law restricts this drug to use by or perazine citrate suspension. on the order of a licensed veterinarian. (a) Specifications. Each milliliter of suspension contains 69 milligrams (mg) [75 FR 67031, Nov. 1, 2010] dithiazanine iodide and 83 mg piper- § 520.784 Doxylamine. azine base (as piperazine citrate). (b) Sponsor. See No. 054628 in (a) Specifications. The drug is in tab- § 510.600(c) of this chapter. let form and contains doxylamine succinate as the active drug ingredient. (c) Conditions of use in horses—(1) (b) Sponsor. See No. 000061 in Amount. 1 ounce (30 milliliters) per 100 § 510.600(c) of this chapter. pounds of body weight for the first 500 (c) Conditions of use—(1) Amount. 3 pounds; ⁄4 ounce for each 100 pounds Horses: Administer orally 1 to 2 milli- 1 thereafter, up to 1,200 pounds; 10 ⁄4 grams (mg) per pound (/lb) of body ounces to animals over 1,200 pounds. weight per day divided into 3 or 4 equal (2) Indications for use. For control of doses. Dogs and cats: Administer orally large roundworms, Parascaris equorum; 2 to 3 mg/lb of body weight per day di- small strongyles; large strongyles, vided into 3 or 4 equal doses. Strongylus vulgaris; and pinworms, (2) Indications for use. For use when Oxyuris equi. antihistaminic therapy may be ex- (3) Limitations. Administer by drench pected to alleviate some signs of dis- or mixed with the daily ration as a sin- ease in horses, dogs, and cats. gle dose. Treatment is recommended in (3) Limitations. Do not use in horses spring and fall. In a heavily infested intended for human consumption. Fed- environment, treatment may be re- eral law restricts this drug to use by or peated every 30 days. Not for use in on the order of a licensed veterinarian. horses intended for food purposes. Se- [40 FR 13838, Mar. 27, 1975, as amended at 42 verely debilitated animals should not FR 60140, Nov. 25, 1977; 46 FR 48642, Oct. 2, be wormed except on the advice of a 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, veterinarian. If the drug is for adminis- Nov. 19, 1997; 79 FR 28821, May 20, 2014] tration by stomach tube, it shall be labeled: ‘‘Federal law restricts this drug § 520.804 Enalapril. to use by or on the order of a licensed (a) Specifications. Each tablet con- veterinarian.’’ tains 1.0, 2.5, 5.0, 10, or 20 milligrams (mg) of enalapril maleate. [47 FR 52696, Nov. 23, 1982, as amended at 48 (b) Sponsor. See No. 050604 in FR 32342, July 15, 1983; 53 FR 40727, Oct. 18, § 510.600(c) of this chapter. 1988; 62 FR 35076, June 30, 1997; 78 FR 21059, Apr. 9, 2013; 79 FR 28820, May 20, 2014] (c) Conditions of use in dogs—(1) Amount. Administer orally 0.5 to 1.0 mg

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of enalapril maleate per kilogram of (ii) Indications for use. Removal of ca- body weight per day. nine cestodes Dipylidium caninum and (2) Indications for use. For the treat- Taenia pisiformis. ment of mild, moderate, and severe (2) Cats—(i) Amount. 1.25 milligrams (modified New York Heart Association per pound of body weight. Class II, III, IV) heart failure in dogs. (ii) Indications for use. Removal of fe- (3) Limitations. Federal law restricts line cestodes D. caninum and T. this drug to use by or on the order of a taeniaeformis. licensed veterinarian. (3) Limitations. Federal law restricts this drug to use by or on the order of a [79 FR 28821, May 20, 2014, as amended at 80 licensed veterinarian. FR 34278, June 16, 2015] [54 FR 50615, Dec. 8, 1989, as amended at 56 § 520.812 Enrofloxacin. FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR 28821, May 20, 2014] (a) Specifications. Each tablet contains: § 520.823 Erythromycin. (1) 22.7, 68.0, or 136.0 milligrams (mg) (a) Specifications. Each gram of pow- enrofloxacin; or der contains erythromycin phosphate (2) 22.7, 68.0, 136.0, or 272 mg equivalent to 0.89 gram of erythro- enrofloxacin. mycin master standard. (b) Sponsors. See sponsor numbers in (b) Sponsor. See No. 061623 in § 510.600(c) of this chapter for use as in § 510.600(c) of this chapter. paragraph (c) of this section. (c) Related tolerances. See § 556.230 of (1) Nos. 000859 and 026637 for use of this chapter. product described in paragraph (a)(1) of (d) Conditions of use. It is used in this section. drinking water as follows: (2) No. 058198 for use of product de- (1) Broiler and replacement chickens— scribed in paragraph (a)(2) of this sec- (i) Amount. Administer 0.500 gram per tion. gallon for 5 days. (c) Conditions of use in dogs and cats— (ii) Indications for use. As an aid in (1) Amount. Administer orally as a sin- the control of chronic respiratory dis- gle, daily dose or divided into two ease due to Mycoplasma gallisepticum equal doses at 12-hour intervals. susceptible to erythromycin. (i) Dogs. 5 to 20 mg per kilogram (/kg) (iii) Limitations. Do not use in re- (2.27 to 9.07 mg per pound (/lb)) of body placement pullets over 16 weeks of age. weight. Do not use in chickens producing eggs (ii) Cats. 5 mg/kg (2.27 mg/lb) of body for human consumption. Withdraw 1 weight. day before slaughter. Federal law re- (2) Indications for use. For the man- stricts this drug to use by or on the agement of diseases associated with order of a licensed veterinarian. bacteria susceptible to enrofloxacin. (2) Replacement chickens and chicken (3) Limitations. Federal law restricts breeders—(i) Amount. Administer 0.500 this drug to use by or on the order of a gram per gallon for 7 days. licensed veterinarian. Federal law pro- (ii) Indications for use. As an aid in hibits the extralabel use of this drug in the control of infectious coryza due to food-producing animals. Haemophilus gallinarum susceptible to erythromycin. [78 FR 30197, May 22, 2013, as amended at 78 (iii) Limitations. Do not use in re- FR 52853, Aug. 27, 2013] placement pullets over 16 weeks of age. Do not use in chickens producing eggs § 520.816 Epsiprantel. for human consumption. Withdraw 1 (a) Specifications. Each tablet con- day before slaughter. Federal law re- tains either 12.5, 25, 50, or 100 milli- stricts this drug to use by or on the grams of epsiprantel. order of a licensed veterinarian. (b) Sponsor. See No. 050604 in (3) Growing turkeys—(i) Amount. Ad- § 510.600(c) of this chapter. minister 0.500 gram per gallon for 7 (c) Conditions of use—(1) Dogs—(i) days. Amount. 2.5 milligrams per pound of (ii) Indications for use. As an aid in body weight. the control of blue comb (nonspecific

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infectious enteritis) caused by orga- § 520.870 Etodolac. nisms susceptible to erythromycin. (a) Specifications. Each tablet con- (iii) Limitations. Do not use in tur- tains 150, 300, or 500 milligrams (mg) of keys producing eggs for human con- etodolac. sumption. Withdraw 1 day before (b) Sponsor. See No. 000010 in slaughter. Federal law restricts this § 510.600(c) of this chapter. drug to use by or on the order of a li- (c) Conditions of use in dogs—(1) censed veterinarian. Amount. Administer 10 to 15 mg per [40 FR 13838, Mar. 27, 1975, as amended at 45 kilogram (4.5 to 6.8 mg per pound) of FR 56798, Aug. 26, 1980; 66 FR 14073, Mar. 9, body weight per day orally. 2001; 68 FR 4914, Jan. 31, 2003; 79 FR 28821, (2) Indications for use. For the man- May 20, 2014; 81 FR 17607, Mar. 30, 2016; 81 FR agement of pain and inflammation as- 94989, Dec. 27, 2016] sociated with osteoarthritis. (3) Limitations. Federal law restricts § 520.852 Estriol. this drug to use by or on the order of a (a) Specifications. Each tablet con- licensed veterinarian. tains 1 milligram (mg) estriol. [63 FR 51300, Sept. 25, 1998, as amended at 68 (b) Sponsor. See No. 000061 in FR 51705, Aug. 28, 2003; 75 FR 10166, Mar. 5, § 510.600(c) of this chapter. 2010; 79 FR 28821, May 20, 2014] (c) Conditions of use in dogs—(1) Amount. Administer at an initial dose § 520.903 Febantel oral dosage forms. of 2 mg per dog per day. The dosage § 520.903a Febantel paste. may be titrated to as low as 0.5 mg per dog every second day, depending on re- (a) Specifications. Each gram of paste sponse. contains 455 milligrams (45.5 percent) (2) Indications for use. For the control febantel. of estrogen-responsive urinary inconti- (b) Sponsor. See No. 000859 in § 510.600(c) of this chapter. nence in ovariohysterectomized female (c) Conditions of use in horses—(1) dogs. Amount. Administer paste orally at 6 (3) Limitations. Federal law restricts milligrams per kilogram (2.73 milli- this drug to use by or on the order of a grams per pound) of body weight on the licensed veterinarian. base of the tongue or well mixed into a [76 FR 78150, Dec. 16, 2011] portion of the normal grain ration. For animals maintained on premises where § 520.863 Ethylisobutrazine. reinfection is likely to occur, retreatment may be necessary. For most ef- (a) Specifications. Each tablet con- fective results, retreat in 6 to 8 weeks. tains either 10 milligrams or 50 milli- (2) Indications for use. For removal of grams of ethylisobutrazine hydro- large strongyles (Strongylus vulgaris, S. chloride. edentatus, S. equinus); ascarids (b) Sponsor. See No. 000061 in (Parascaris equorum—sexually mature § 510.600(c) of this chapter. and immature); pinworms (Oxyuris (c) Conditions of use in dogs—(1) equi—adult and 4th stage larva); and Amount. Administer orally 2 to 5 milli- various small strongyles in horses, grams per pound of body weight once foals, and ponies. daily. (3) Limitations. Do not use in horses (2) Indications for use. As a tranquil- intended for human consumption. Con- izer. sult your veterinarian for assistance in (3) Limitations. Federal law restricts the diagnosis, treatment, and control this drug to use by or on the order of a of parasitism. licensed veterinarian. [79 FR 28821, May 20, 2014] [40 FR 13838, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; § 520.903b Febantel suspension. 62 FR 61624, Nov. 19, 1997; 79 FR 28821, May 20, (a) Specifications. Each ounce of sus- 2014] pension contains 2.75 grams (9.3 percent ounce) febantel.

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(b) Sponsor. See No. 000859 in (ii) Puppies and kittens (less than 6 § 510.600(c) of this chapter. months of age): 15 milligrams of (c) Conditions of use in horses—(1) febantel and 1.5 milligrams of Amount. 3 milliliters per 100 pounds praziquantel per kilogram of body body weight or 1 fluid ounce per 1000 weight (1 gram of paste per 5 pounds pounds (6 milligrams per kilogram body weight) administered by mouth body weight). Administer by stomach on a full stomach once daily for 3 days. tube or drench, or by mixing well into (2) Indications for use. (i) Dogs and a portion of the normal grain ration. puppies: For removal of hookworms For animals maintained on premises (Ancylostoma caninum and Uncinaria where reinfection is likely to occur, re- stenocephala), whipworms (Trichuris treatment may be necessary. For most vulpis), ascarids (Toxocara canis and effective results, retreat in 6 to 8 Toxascaris leonina), and tapeworms weeks. (Dipylidium caninum and Taenia (2) Indications for use. For removal of pisiformis). ascarids (Parascaris equorum—adult and (ii) Cats and kittens: For removal of sexually immature), pinworms (Oxyuris hookworms (Ancylostoma tubaeforme), equi—adult and 4th stage larvae), large ascarids (Toxocara cati) and tapeworms strongyles (Strongylus vulgaris, S. (Dipylidium caninum and Taenia edentatus, S. equinus), and various taeniaeformis). small strongyles in horses, breeding (3) Limitations. Federal law restricts stallions and mares, pregnant mares, this drug to use by or on the order of a foals, and ponies. licensed veterinarian. (3) Limitations. Do not use in horses intended for human consumption. Fed- [50 FR 19167, May 7, 1985, as amended at 53 eral law restricts this drug to use by or FR 48533, Dec. 1, 1988; 56 FR 50813, Oct. 9, 1991; on the order of a licensed veterinarian. 79 FR 28821, May 20, 2014] (d) Special considerations. Febantel suspension may be used in combination § 520.903e Febantel tablets. with trichlorfon oral liquid in accord- (a) Specifications. Each scored tablet ance with the provisions of § 520.2520c, contains 27.2 milligrams of febantel for this section, and the following condi- use in dogs, puppies, cats, and kittens tions: or 163.3 milligrams of febantel for use (1) Combine 1 part febantel suspen- in dogs, puppies, and cats. sion with 5 parts trichlorfon liquid. (b) Sponsor. See No. 000859 in (2) Allow animal to consume a por- § 510.600(c) of this chapter. tion of daily grain ration; administer (c) Conditions of use—(1) Amount—(i) mixture by stomach tube at rate of 18 Dogs and cats. Ten milligrams per kilo- milliliters per 100 pounds of body gram body weight. Administer once weight. daily for 3 consecutive days. [45 FR 8587, Feb. 8, 1980, as amended at 79 FR (ii) Puppies and kittens fewer than 6 28821, May 20, 2014] months of age. Fifteen milligrams per kilogram body weight. Administer once § 520.903c [Reserved] daily for 3 consecutive days. § 520.903d Febantel and praziquantel (2) Indications for use. (i) For removal paste. of hookworms (Ancylostoma caninum and Uncinaria stenocephala), ascarids (a) Specifications. Each gram of paste (Toxocara canis and Toxascaris leonina) contains 34 milligrams of febantel and and whipworms (Trichuris vulpis) in 3.4 milligrams of praziquantel. dogs and puppies. (b) Sponsor. See No. 000859 in (ii) For removal of hookworms § 510.600(c) of this chapter. (Ancylostoma tubaeforme) and ascarids (c) Conditions of use—(1) Amount—(i) (Toxocara cati) in cats and kittens. Dogs and cats (over 6 months of age): 10 milligrams of febantel and 1 milligram (3) Limitations. Federal law restricts of praziquantel per kilogram of body this drug to use by or on the order of a weight (1 gram of paste per 7.5 pounds licensed veterinarian. body weight) administered by mouth or [56 FR 50655, Oct. 8, 1991, as amended at 79 FR in the food once daily for 3 days. 28821, May 20, 2014]

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§ 520.905 Fenbendazole oral dosage hookworm (Bunostonmum phlebotomum), forms. threadnecked intestinal worm (Nematodirus helvetianus), small intes- § 520.905a Fenbendazole suspension. tinal worm (Cooperia punctata and C. (a) Specifications. Each milliliter of oncophora), bankrupt worm suspension contains 100 milligrams (Trichostrongylus colubriformis), and (mg) fenbendazole for use as in para- nodular worm (Oesophagostomum graphs (e)(1), (2), (3), and (4) of this sec- radiatum). tion; or 200 mg fenbendazole for use as (iii) Limitations. Cattle must not be in paragraphs (e)(5) and (6) of this sec- slaughtered within 8 days following tion. last treatment. A withdrawal period (b) Sponsor. See No. 000061 in has not been established for this prod- § 510.600(c) of this chapter. uct in preruminating calves. Do not (c) Related tolerances. See § 556.275 of use in calves to be processed for veal. this chapter. (3) Beef cattle—(i) Amount. Administer (d) Special considerations. (1) See orally 10 mg/kg of body weight (2.3 mg/ § 500.25 of this chapter. lb). Retreatment may be needed after 4 (2) Fenbendazole suspension 10 per- to 6 weeks. cent and approved forms of trichlorfon, (ii) Indications for use. For the re- when used concomitantly for treating moval and control of stomach worm the indications provided in paragraph (4th stage inhibited larvae/type II (e) of this section and for treating in- ostertagiasis), Ostertagia ostertagi, and fections of stomach bot as provided in tapeworm, Moniezia benedeni. § 520.2520, have been shown to be com- (iii) Limitations. Cattle must not be patible and not to interfere with one slaughtered within 8 days following another. last treatment. A withdrawal period (e) Conditions of use—(1) Horses—(i) has not been established for this prod- Amount. Administer orally 5 mg per uct in preruminating calves. Do not kilogram (/kg) (2.3 mg per pound (/lb)) use in calves to be processed for veal. for the control of large strongyles, Federal law restricts this drug to use small strongyles, and pinworms; 10 mg/ by or on the order of a licensed veteri- kg for the control of ascarids. narian. (ii) Indications for use. For the control (4) Goats—(i) Amount. Administer of large strongyles (Strongylus orally 5 mg/kg of body weight (2.3 mg/ edentatus, S. equinus, S. vulgaris), small lb). Retreatment may be needed after 4 strongyles (Cyanthostomum spp., to 6 weeks. Cylicocyclus spp., Cylicostephanus spp., (ii) Indications for use. For the re- Triodontophorus spp.), pinworms moval and control of stomach worms (Oxyuris equi), and ascarids (Parascaris (adults) Haemonchus contortus and equorum) in horses. Teladorsagia circumcincta. (iii) Limitations. Administer by dose (iii) Limitations. Goats must not be syringe or suitable plastic syringe. Do slaughtered for food within 6 days fol- not use in horses intended for human lowing last treatment. Do not use in consumption. lactating goats. (2) Cattle including dairy cows of breed- (5) Chickens—(i) Amount. Administer ing age—(i) Amount. Administer orally 5 orally via drinking water at a daily mg/kg of body weight (2.3 mg/lb). Re- dose of 1 mg/kg body weight (0.454 mg/ treatment may be needed after 4 to 6 lb) for 5 consecutive days. weeks. (ii) Indications for use. For the treat- (ii) Indications for use. For the re- ment and control of adult Ascaridia moval and control of lungworm galli in broiler chickens and replace- (Dictyocaulus viviparus); stomach worm ment chickens intended to become (adults)—brown stomach worm breeding chickens, and for the treat- (Ostertagia ostertagi); stomach worms ment and control of adult A. galli and (adults and 4th-stage larvae)— Heterakis gallinarum in breeding chick- barberpole worm (Haemonchus contortus ens. and H. placei) and small stomach worm (iii) Limitations. Not for use in laying (Trichostongylus axei); intestinal worms hens and replacement chickens in- (adults and 4th-stage larvae)— tended to become laying hens.

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(6) Swine, except for nursing piglets—(i) Retreat in 6 to 8 weeks if required. Do Amount. Administer orally via the not use in horses intended for food. drinking water at a daily dose of 2.2 (2) Dogs—(i) Amount. 50 mg/kg daily mg/kg of body weight (1.0 mg/lb) for 3 for 3 consecutive days. consecutive days. (ii) Indications for use. For the treat- (ii) Indications for use. For the treatment and control of ascarids (Toxocara ment and control of lungworms: Adult canis, Toxascaris leonina), hookworms Metastrongylus apri, adult M. (Ancylostoma caninum, Uncinaria pudendotectus; gastrointestinal worms: stenocephala), whipworms (Trichuris Adult and larvae (L3, L4 stages, liver, vulpis), and tapeworms (Taenia lung, intestinal forms) large pisiformis). roundworms (Ascaris suum); nodular (iii) Limitations. Mix the appropriate worms (Oesophagostomum dentatum, O. quadrispinulatum); small stomach amount of drug with a small amount of worms (Hyostrongylus rubidus): Adult the usual food; dry dog food may re- and larvae (L2, L3, L4 stages—intes- quire slight moistening to facilitate tinal mucosal forms) whipworms mixing. Medicated food must be fully (Trichuris suis); and kidney worms: consumed. Adult and larvae Stephanurus dentatus. (3) Zoo and wildlife animals—(i) (iii) Limitations. Swine intended for Amount. 10 mg/kg per day for 3 days. human consumption must not be (ii) Indications for use. For control of slaughtered within 2 days from the last internal parasites of Felidae and treatment. Ursidae as follows: [42 FR 59069, Nov. 15, 1977; 43 FR 12311, Mar. (A) Lion (Panthera leo) and Tiger 24, 1978. Redesignated at 44 FR 1375, Jan. 5, (Panthera tigris): Ascarid (Toxocara cati, 1979, and amended at 46 FR 29464, June 2, Toxascaris leonina), Hookworm 1981; 47 FR 15327, Apr. 9, 1982; 48 FR 42809, (Ancylostoma spp.). Sept. 20, 1983; 49 FR 1983, Jan. 17, 1984; 53 FR (B) Cheetah (Acinonyx jubatus): Asca- 40058, Oct. 13, 1988; 59 FR 26943, May 25, 1994; rid (Toxocara cati, Toxascaris leonina). 61 FR 29478, June 11, 1996; 63 FR 63983, Nov. 18, 1998; 66 FR 47960, Sept. 17, 2001; 68 FR (C) Puma (Felis concolor), Panther 26205, May 15, 2003; 74 FR 17770, Apr. 17, 2009; (Panthera spp.), Leopard (Panthera 74 FR 61516, Nov. 25, 2009; 76 FR 17336, Mar. pardus), Jaguar (Panthera onca): Asca- 29, 2011; 80 FR 76386, Dec. 9, 2015; 81 FR 22523, rid (Toxocara cati, Toxascaris leonina), Apr. 18, 2016] Hookworm (Ancylostoma spp.), Tape- worm (Taenia hydatigena, T. krabbei, T. § 520.905b Fenbendazole granules. taeniaeformis). (a) Specifications. Each gram of gran- (D) Black Bear (Ursus americanus): ules contains 222 milligrams (mg) Ascarid (Baylisascaris transfuga, fenbendazole. Toxascaris leonina), Hookworm (b) Sponsor. See No. 000061 in (Ancylostoma caninum), Tapeworm § 510.600(c) of this chapter. (Taenia hydatigena, T. krabbei). (c) Special considerations. See § 500.25 (E) Polar Bear (Ursus maritimus) and of this chapter. Grizzly Bear (Ursus horribilis): Ascarid (d) —(1) —(i) Conditions of use Horses (Baylisascaris transfuga, Toxascaris Amount. 5 mg/kilogram (kg) for large leonina). strongyles, small strongyles, and pinworms; 10 mg/kg for ascarids. (iii) Limitations. Top dress or mix with a small portion of food. Must be (ii) Indications for use. For the control of infections of large strongyles fully consumed prior to feeding. Fed- (Strongylus edentatus, S. equinus, S. eral law restricts this drug to use by or vulgaris), small strongyles, pinworms on the order of a licensed veterinarian. (Oxyuris equi), and ascarids (Parascaris Do not use 14 days before or during the equorum). hunting season. (iii) Limitations. Sprinkle the appro- [44 FR 1375, Jan. 5, 1979, as amended at 47 FR priate amount of drug on a small 15327, Apr. 9, 1982; 48 FR 50528, Nov. 2, 1983; 59 amount of the usual grain ration. Pre- FR 35252, July 11, 1994; 66 FR 47960, Sept. 17, pare for each horse individually. With- 2001; 67 FR 47450, July 19, 2002; 71 FR 19429, holding feed or water is not necessary. Apr. 14, 2006; 74 FR 61516, Nov. 25, 2009]

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§ 520.905c Fenbendazole paste. uct in preruminating calves. Do not (a) Specifications. Each gram of paste use in calves to be processed for veal. contains 100 milligrams (mg) [72 FR 24185, May 2, 2007, as amended at 74 fenbendazole (10 percent). FR 61516, Nov. 25, 2009; 76 FR 17337, Mar. 29, (b) Sponsor. See No. 000061 in 2011] § 510.600(c) of this chapter. (c) Related tolerances. See § 556.275 of § 520.905d Fenbendazole powder. this chapter. (a) Specifications. (1) Each 2-ounce (d) Special considerations. See § 500.25 packet contains 2.27 grams (4 percent) of this chapter. of fenbendazole plus other inert ingre- (e) Conditions of use—(1) Horses—(i) dients. Indications for use and amounts—(A) For (2) Each 4-ounce packet contains 1.7 control of large strongyles (Strongylus grams (1.5 percent) of fenbendazole plus edentatus, S. equinus, S. vulgaris), small other inert ingredients. strongyles, pinworms (Oxyuris equi), (b) Sponsors. (1) See No. 000061 in and ascarids (Parascaris equorum): 2.3 § 510.600(c) of this chapter for use of the mg per pound (/lb) of body weight, or 4-percent product. for foals and weanlings (less than 18 (2) See No. 051311 in § 510.600(c) of this months of age), 4.6 mg/lb of body chapter for use of the 1.5-percent prod- weight. Retreatment at intervals of 6 uct. to 8 weeks may be required. (c) Related tolerances. See § 556.275 of (B) For control of arteritis caused by this chapter. the fourth-stage larvae of S. vulgaris: (d) Conditions of use. It is adminis- 4.6 mg/lb of body weight daily for 5 tered to swine as follows: days. Treatment should be initiated in (1) Amount. 3 milligrams fenbendazole the spring and repeated in 6 months. per kilogram body weight per day (1.36 (C) For treatment of encysted milligrams per pound per day). mucosal cyathostome (small strongyle) larvae including early third-stage (2) Indications for use. For removal (hypobiotic), late third-stage, and and control of large roundworms fourth-stage larvae: 4.6 mg/lb of body (Ascaris suum); lungworms weight daily for 5 consecutive days. (Metastrongylus apri); nodular worms (D) Fenbendazole paste 10 percent (Oesophagostomum dentatum, O. may be used concomitantly with ap- quadrispinulatum); small stomach proved forms of trichlorfon for the in- worms (Hyostrongylus rubidus); dications provided in paragraph whipworms (Trichuris suis); and (e)(1)(i)(A) of this section and for treat- kidneyworms (Stephanurus dentatus— ing infections of stomach bots as pro- mature and immature). vided in § 520.2520. (3) Limitations. Thoroughly mix the (ii) Limitations. Do not use in horses contents of the packet(s) with swine intended for human consumption. ration and administer according to (2) Cattle—(i) Amount. 2.3 mg/lb of label directions. Feed as sole ration for body weight. Retreatment may be 3 consecutive days. Can be fed to preg- needed after 4 to 6 weeks. nant sows. No prior withdrawal of feed (ii) Indications for use. For the re- or water is necessary. Consult your moval and control of lungworms veterinarian for assistance in the diag- (Dictyocaulus viviparus), stomach nosis, treatment, and control of para- worms (Haemonchus contortus, sitism. Ostertagia ostertagi, Trichostrongylus [49 FR 18090, Apr. 27, 1984, as amended at 49 axei), and intestinal worms FR 20485, May 15, 1984; 66 FR 47960, Sept. 17, (Bunostomum phlebotomum, Nematodirus 2001; 70 FR 32489, June 3, 2005; 74 FR 61516, helvetianus, Cooperia punctata, C. Nov. 25, 2009] oncophora, Trichostrongylus colubriformis, and Oesophagostomum § 520.905e Fenbendazole blocks. radiatum). (a) Specifications. (1) Each pound of (iii) Limitations. Cattle must not be molasses block contains 750 milligrams slaughtered within 8 days following of fenbendazole. last treatment. A withdrawal period (2) Each pound of protein block con- has not been established for this prod- tains 750 milligrams of fenbendazole.

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(b) Sponsor. See 000061 in § 510.600(c) of (iii) Limitations. Federal law restricts this chapter. this drug to use by or on the order of a (c) Related tolerances. See § 556.275 of licensed veterinarian. this chapter. (2) Horses—(i) Amount. Administer (d) Conditions of use—(1) Amount. 0.1 one 57-mg tablet to horses weighing 800 pound of block per 100 pounds of body to 1,300 lb once daily for up to 14 days. weight per day for 3 days. Total dose (ii) Indications for use. For the control for the 3-day period is 2.27 milligrams of pain and inflammation associated of fenbendazole per pound of body with osteoarthritis. weight for mature cattle. (iii) Limitations. Do not use in horses (2) Indications for use. For removal intended for human consumption. Fed- and control of infections of lungworms eral law restricts this drug to use by or (Dictyocaulus viviparus) and gastro- on the order of a licensed veterinarian. intestinal roundworms (Haemonchus contortus, Ostertagia ostertagi, [69 FR 51171, Aug. 18, 2004, as amended at 73 Trichostrongylus axei, Bunostomum FR 2808, Jan. 16, 2008; 73 FR 64885, Oct. 31, phlebotomum, Nematodirus helvetianus, 2008; 81 FR 67151, Sept. 30, 2016] Cooperia oncophora and C. punctata, Trichostrongylus colubriformis, and § 520.930 Firocoxib paste. Oesophagostomum radiatum) in beef cat- (a) Specifications. Each milligram tle. (mg) of paste contains 0.82 mg (3) Limitations. Administer free choice firocoxib. of beef cattle on pasture that have be- (b) Sponsors. See No. 050604 in come accustomed to nonmedicated § 510.600(c) of this chapter. block feeding during an adaptation pe- (c) Conditions of use in horses—(1) riod of 12 to 19 days. Molasses block: Amount. 0.1 mg per kilogram (0.045 mg Cattle must not be slaughtered within per pound) body weight daily for up to 11 days following last treatment. Pro- 14 days. tein block: Cattle must not be slaugh- (2) Indications for use. For the control tered within 16 days following last of pain and inflammation associated treatment; do not use in dairy cattle of with osteoarthritis. breeding age. Animals maintained (3) Limitations. Do not use in horses under conditions of constant worm ex- intended for human consumption. Fed- posure may require retreatment within eral law restricts this drug to use by or 6 to 8 weeks. Consult your veterinarian on the order of a licensed veterinarian. for assistance in the diagnosis, treatment, and control of parasitism. [71 FR 5788, Feb. 3, 2006] [51 FR 41783, Nov. 19, 1986, as amended at 54 § 520.955 Florfenicol. FR 20787, May 15, 1989; 66 FR 47960, Sept. 17, 2001; 74 FR 61516, Nov. 25, 2009] (a) Specifications. Each milliliter (mL) contains 23 milligrams (mg) § 520.928 Firocoxib tablets. florfenicol. (a) Specifications. Each chewable tab- (b) Sponsors. See Nos. 000061, 054925, let contains 57 or 227 milligrams (mg) and 058198 in § 510.600(c) of this chapter. firocoxib. (c) Related tolerances. See § 556.283 of (b) Sponsor. See No. 050604 in this chapter. § 510.600(c) of this chapter. (d) Conditions of use in swine—(1) (c) Conditions of use—(1) Dogs—(i) Amount. Administer in drinking water Amount. 5 mg/kg (2.27 mg/lb) body ad libitum at 400 mg per gallon (100 weight. Administer once daily for os- parts per million (ppm)) for 5 consecu- teoarthritis. Administer approximately tive days. 2 hours before soft tissue or orthopedic (2) Indications for use. For the treat- surgery. ment of swine respiratory disease (ii) Indications for use. For the control (SRD) associated with Actinobacillus of pain and inflammation associated pleuropneumoniae, Pasteurella multocida, with osteoarthritis; and for the control Salmonella choleraesuis and Strepto- of postoperative pain and inflamma- coccus suis. tion associated with soft-tissue and or- (3) Limitations. Do not slaughter with- thopedic surgery. in 16 days of last treatment. Federal

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law restricts this drug to use by or on eral law restricts this drug to use by or the order of a licensed veterinarian. on the order of a licensed veterinarian. [67 FR 78357, Dec. 24, 2002, as amended at 72 [76 FR 53051, Aug. 25, 2011, as amended at 79 FR 262, Jan. 4, 2007; 78 FR 52854, Aug. 27, 2013; FR 74020, Dec. 15, 2014] 82 FR 12169, Mar. 1, 2017] § 520.980 Fluoxetine. § 520.960 Flumethasone. (a) Specifications. Each chewable tab- (a) Specifications. Each tablet con- let contains 8, 16, 32, or 64 milligrams tains 0.0625 milligram of flumethasone. (mg) fluoxetine hydrochloride. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (b) Sponsor. See No. 055246 in § 510.600 (c) Conditions of use—(1) Amount—(i) of this chapter. Dogs: Administer orally from 0.0625 to (c) Conditions of use in dogs—(1) 0.25 milligram daily in divided doses. Amount. 1 to 2 mg per kilogram body (ii) Cats: Administer orally from weight once daily. 0.03125 to 0.125 milligram daily in di- (2) Indications for use. For the treat- vided doses. ment of canine separation anxiety in (2) Indications for use—(i) Dogs: It is conjunction with a behavior modifica- used for musculoskeletal conditions tion plan. due to inflammation of muscles or (3) Limitations. Federal law restricts joints and accessory structures, where this drug to use by or on the order of a permanent structural changes do not licensed veterinarian. exist, such as arthritis, the disc syndrome, and myositis. [72 FR 6463, Feb. 12, 2007, as amended at 79 (ii) Dogs and cats: It is used in certain FR 74020, Dec. 15, 2014; 82 FR 21690, May 10, acute and chronic dermatoses of vary- 2017] ing etiology to help control the pru- § 520.998 Fluralaner. ritus, irritation, and inflammation associated with these conditions. (a) Specifications. Each chewable tab- (3) Limitations. Federal law restricts let contains 112.5, 250, 500, 1000, or 1400 this drug to use by or on the order of a milligrams (mg) fluralaner. licensed veterinarian. (b) Sponsor. See No. 000061 in [44 FR 7131, Feb. 6, 1979, as amended at 61 FR § 510.600(c) of this chapter. 5506, Feb. 13, 1996; 79 FR 28821, May 20, 2014] (c) Conditions of use in dogs—(1) Amount. Administer orally as a single § 520.970 Flunixin. dose every 12 weeks according to the (a) Specifications. (1) Each 10-gram (g) label dosage schedule to provide a min- packet of granules contains flunixin imum dose of 11.4 mg per pound (/lb) (25 meglumine equivalent to 250 milli- mg per kilogram) body weight. May be grams (mg) of flunixin. administered every 8 weeks in case of (2) Each 30-g syringe of paste con- potential exposure to Amblyomma tains flunixin meglumine equivalent to americanum ticks. 1,500 mg of flunixin. (2) Indications for use. Kills adult (b) Sponsors. See sponsors in fleas; for the treatment and prevention § 510.600(c) of this chapter for use as in of flea infestations (Ctenocephalides paragraph (c) of this section. felis), and the treatment and control of (1) No. 000061 for use of products de- tick infestations [Ixodes scapularis scribed in paragraph (a). (black-legged tick), Dermacentor (2) No. 061623 for use of the product variabilis (American dog tick), and described in paragraph (a)(2). Rhipicephalus sanguineus (brown dog (c) Conditions of use in horses—(1) tick)] for 12 weeks in dogs and puppies Amount. 0.5 mg per pound of body 6 months of age and older, and weigh- weight per day for up to 5 days. ing 4.4 lb or greater; for the treatment (2) Indications for use. For alleviation and control of A. americanum (lone star of inflammation and pain associated with musculoskeletal disorders. tick) infestations for 8 weeks in dogs (3) Limitations. Do not use in horses and puppies 6 months of age and older, intended for human consumption. Fed- and weighing 4.4 lb or greater.

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(3) Limitations. Federal law restricts (2) Dogs—(i) Amount. 1 to 2 mg/lb body this drug to use by or on the order of a weight, once or twice daily. licensed veterinarian. (ii) Indications for use—(A) For treat- [79 FR 37619, July 2, 2014] ment of edema (pulmonary congestion, ascites) associated with cardiac insuffi- § 520.1010 Furosemide. ciency and acute noninflammatory tis- (a) Specifications. (1) Each tablet con- sue edema. tains 12.5 or 50 milligrams (mg) (B) For treatment of edema (pul- furosemide. monary congestion, ascites) associated (2) Each bolus contains 2 grams (g) with cardiac insufficiency. furosemide. (3) Cats—(i) Amount. 1 to 2 mg/lb body (3) Each packet of powder contains 2 weight, once or twice daily. g furosemide. (ii) Indications for use. For treatment (4) Each milliliter of syrup contains of edema (pulmonary congestion, asci- 10 mg furosemide. tes) associated with cardiac insuffi- (b) Sponsors. See sponsor numbers in ciency and acute noninflammatory tis- § 510.600(c) of this chapter for use of sue edema. dosage forms and strengths listed in paragraph (a) of this section for uses as [66 FR 47960, Sept. 17, 2001, as amended at 69 in paragraph (d) of this section. FR 74419, Dec. 14, 2004; 70 FR 50182, Aug. 26, 2005; 70 FR 76396, Dec. 27, 2005; 74 FR 61516, (1) No. 000010 for tablets in paragraph Nov. 25, 2009; 78 FR 17596, Mar. 22, 2013; 81 FR (a)(1) of this section for conditions of 17607, Mar. 30, 2016] use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of this section. § 520.1044 Gentamicin sulfate oral dos- (2) No. 000061 for tablets in paragraph age forms. (a)(1) of this section for conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), § 520.1044a Gentamicin sulfate oral so- and (d)(3) of this section; for boluses in lution. paragraph (a)(2) of this section and (a) Specifications. Each milliliter of powder in paragraph (a)(3) of this sec- aqueous solution contains gentamicin tion for conditions of use in paragraph sulfate equivalent to 50 milligrams of (d)(1) of this section; and for syrup in gentamicin. paragraph (a)(4) of this section for con- (b) Sponsor. See Nos. 000061 and 054925 ditions of use in paragraphs (d)(2)(i) and (d)(2)(ii)(A). in § 510.600(c) of this chapter. (3) Nos. 058829 and 069043 for use of (c) Related tolerances. See § 556.300 of syrup in paragraph (a)(4) of this section this chapter. for conditions of use in paragraph (d) Conditions of use—(1) Amount. (d)(2)(i) and (d)(2)(ii)(A) of this section. Colibacillosis: 1 milliliter per 2 gallons (c) Special considerations. Federal law of drinking water for 3 consecutive restricts this drug to use by or on the days, to provide 0.5 milligram/pound/ order of a licensed veterinarian. day; swine dysentery: 1 milliliter per 1 (d) Conditions of use. It is used as fol- gallon of drinking water for 3 consecu- lows: tive days, to provide 1.0 milligram/ (1) Cattle—(i) Amount. 1 to 2 mg per pound/day. pound (/lb) body weight using powder, (2) Indications for use. In weanling or one 2-g bolus per animal, per day. swine for control and treatment of (ii) Indications for use. For treatment colibacillosis caused by strains of E. of physiological parturient edema of coli sensitive to gentamicin, and in the mammary gland and associated swine for control and treatment of structures. swine dysentery associated with (iii) Limitations. Treatment not to ex- Treponema hyodysenteriae. ceed 48 hours post-parturition. Milk (3) Limitations. Do not slaughter taken during treatment and for 48 treated swine for food for at least 3 hours after the last treatment must days following treatment. Federal law not be used for food. Cattle must not be slaughtered for food within 48 hours following last treatment.

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restricts this drug to use by or on the 0.5 mg per pound of body weight per order of a licensed veterinarian. day; [48 FR 10302, Mar. 11, 1983. Redesignated at 49 (ii) For swine dysentery: Gentamicin FR 572, Jan. 5, 1984, and amended at 49 FR sulfate equivalent to 50 mg of 14332, Apr. 11, 1984; 52 FR 7832, Mar. 13, 1987; gentamicin per gallon of drinking 62 FR 34169, June 25, 1997; 71 FR 13542, Mar. water to provide 1 mg per pound of 16, 2006; 81 FR 94989, Dec. 27, 2016] body weight per day. Treatment may be repeated if dysentery recurs. § 520.1044b Gentamicin sulfate pig pump oral solution. (2) Indications for use. For control and treatment of colibacillosis in weanling (a) Specifications. Each milliliter of swine caused by strains of Escherichia pig pump oral solution contains coli sensitive to gentamicin, and for gentamicin sulfate equivalent to 4.35 control and treatment of swine dys- milligrams of gentamicin. entery associated with Treponema (b) Sponsor. See Nos. 000061 and 016592 hyodysenteriae. in § 510.600(c) of this chapter. (3) Limitations. Withdrawal period: 10 (c) Related tolerances. See § 556.300 of this chapter. days. Federal law restricts this drug to (d) Conditions of use—(1) Amount. Ad- use by or on the order of a licensed vet- minister 1.15 milliliters of pig pump erinarian. oral solution (5 milligrams of [77 FR 4226, Jan. 27, 2012, as amended at 81 gentamicin) orally per pig one time. FR 94989, Dec. 27, 2016] (2) Indications for use. In neonatal swine 1 to 3 days of age for control and § 520.1060 Glucose and glycine. treatment of colibacillosis caused by (a) Specifications. Each packet of pow- strains of E. coli sensitive to der contains 8.82 grams sodium chlo- gentamicin. ride, 4.20 grams potassium phosphate, (3) Limitations. For use in neonatal 0.5 gram citric acid anhydrous, 0.12 swine only. Do not slaughter treated gram potassium citrate, 6.36 grams swine for food for at least 14 days fol- aminoacetic acid (glycine), and 44.0 lowing treatment. grams glucose. [49 FR 572, Jan. 5, 1984, as amended at 52 FR (b) Sponsor. See No. 054771 in 7832, Mar. 13, 1987; 62 FR 29011, May 29, 1997; § 510.600(c) of this chapter. 78 FR 17596, Mar. 22, 2013; 81 FR 22523, Apr. 18, (c) Conditions of use in calves—(1) 2016] Amount. Dissolve each packet in 2 § 520.1044c Gentamicin sulfate powder. quarts of warm water and administer to each calf as follows: (a) Specifications. Each gram of pow- (i) Scouring and/or dehydrated calves. der contains gentamicin sulfate equiv- Feed 2 quarts of solution, twice daily alent to: (1) 16.7, 66.7, or 333.3 milligrams (mg) for 2 days (four feedings). No milk or gentamicin. milk replacer should be fed during this (2) 333.3 mg gentamicin. period. For the next four feedings (days (b) Sponsors. See sponsors in 3 and 4), use 1 quart of solution to- § 510.600(c) of this chapter for use as in gether with 1 quart of milk replacer. paragraph (d) of this section as follows: Thereafter, feed as normal. (1) No. 000061 for products described (ii) Newly purchased calves. Feed 2 in paragraph (a)(1) of this section. quarts of solution instead of milk as (2) Nos. 057561 and 061623 for product the first feed upon arrival. For the next described in paragraph (a)(2) of this scheduled feeding, use 1 quart of solu- section. tion mixed together with 1 quart of (c) Related tolerances. See § 556.300 of milk or milk replacer. Thereafter, feed this chapter. as normal. (d) Conditions of use in swine—(1) (2) Indications for use. For control of Amount. Administer in drinking water dehydration associated with diarrhea for 3 consecutive days as follows: (scours); and as an early treatment at (i) For colibacillosis: Gentamicin sul- the first signs of scouring. It may also fate equivalent to 25 mg of gentamicin be used as followup treatment fol- per gallon of drinking water to provide lowing intravenous fluid therapy.

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(3) Limitations. The product should ing on feed for not less than 10 days as not be used in animals with severe de- follows: adults, 2.5 grams; yearlings, hydration (down, comatose, or in a 1.25 to 2.5 grams; and foals, 1.25 grams. state of shock). Such animals need in- (B) For treating ringworm infection travenous therapy. A veterinarian caused by T. equinum, administer should be consulted in severely scour- boluses described in paragraph (a)(2) of ing calves. The product is not nutri- this section daily for not less than 10 tionally complete if administered by days as follows: adults, 1 bolus; year- itself for long periods of time. It should lings, one-half to 1 bolus; and foals, not be administered beyond the rec- one-half bolus. ommended treatment period without (ii) Limitations. Do not use in horses the addition of milk or milk replacer. intended for human consumption. [79 FR 28821, May 20, 2014] (2) Dogs and cats: (i) Amount. 125- and 500-milligram tablets administered § 520.1084 Grapiprant. orally as follows: (a) Specifications. Each tablet con- (A) Daily (single or divided) dose as tains 20, 60, or 100 milligrams (mg) follows: For animals weighing up to 6 grapiprant. pounds: 62.5 milligrams; for animals (b) Sponsor. See No. 086026 in weighing 6 to 18 pounds: 125 milli- § 510.600(c) of this chapter. grams; for animals weighing 18 to 36 (c) Conditions of use in dogs—(1) pounds: 250 milligrams; for animals Amount. Administer 0.9 mg/lb (2 mg/kg) weighing 36 to 48 pounds: 375 milli- once daily by mouth. grams; for animal weighing 48 to 75 (2) Indications for use. For the control pounds: 500 milligrams. of pain and inflammation associated (B) Weekly (single) dose: If experi- with osteoarthritis in dogs. ence indicates that treatment is more (3) Limitations. Federal law restricts effective for the drug given in large this drug to use by or on the order of a doses, administer at intervals of 7 to 10 licensed veterinarian. days, a dose equal to 10 milligrams/ pound of body weight × body weight × [81 FR 36789, June 8, 2016] number of days between treatments. § 520.1100 Griseofulvin. Dosage should be adjusted according to response. Administer additional dose (a) Specifications—(1) The powder after the animal is free of infection. complies with U.S.P. for griseofulvin, microsize. (ii) Indications for use. For treatment (2) Each bolus contains 2.5 grams of fungal infections of the skin, hair, griseofulvin. and claws caused by Trichophyton (3) Each tablet contains 125 or 500 mentagrophytes, T. rubrum, T. milligrams griseofulvin. schoenleini, T. sulphurem, T. verrucosum, (b) Sponsors. See sponsors in T. interdigitale, Epidermophyton § 510.600(c) of this chapter. floccosum, Microsporum gypseum, M. (1) No. 000061 for use of products de- canis, M. audouini. scribed in paragraph (a) for use as in [40 FR 13838, Mar. 27, 1975, as amended at 41 paragraph (d) of this section. FR 42948, Sept. 29, 1976; 43 FR 28458, June 30, (2) No. 061623 for use of the powder de- 1978; 52 FR 7832, Mar. 13, 1987; 54 FR 30205, scribed in paragraph (a)(1) for use as in July 19, 1989; 71 FR 38073, July 5, 2006; 77 FR paragraphs (d)(1)(i)(A) and (d)(1)(ii) of 28253, May 14, 2012; 78 FR 28822, May 20, 2014] this section. (c) Special considerations. Federal law § 520.1120 Haloxon oral dosage forms. restricts this drug to use by or on the § 520.1120a Haloxon drench. order of a licensed veterinarian. (d) Conditions of use—(1) Horses—(i) (a) Specifications. Each packet con- Amount and indications for use—(A) For tains 141.5 grams haloxon. equine ringworm infection caused by (b) Sponsor. See No. 000061 in Trichophyton equinum or Microsporum § 510.600(c) of this chapter. gypseum, administer soluble powder de- (c) Special considerations. Do not use scribed in paragraph (a)(1) of this sec- any drug, insecticide, pesticide, or tion daily as a drench or as a top dress- other chemical having cholinesterase-

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inhibiting activity either simulta- § 520.1130 Hetacillin. neously or within a few days before or (a) Specifications. (1) Each capsule or after treatment with haloxon. tablet contains hetacillin potassium (d) Related tolerances. See § 556.310 of this chapter. equivalent to 50, 100, or 200 milligrams (mg) of ampicillin. (e) Conditions of use in cattle—(1) Amount. Dissolve each packet in 32 (2) Each milliliter of suspension con- fluid ounces of water and administer as tains hetacillin potassium equivalent follows: For animals weighing up to 100 to 50 mg of ampicillin. pounds: 1⁄2 fluid ounce; for animals (b) Sponsor. See No. 000010 in weighing 100 to 150 pounds: 3⁄4 fluid § 510.600(c) of this chapter. ounce; for animals weighing 150 to 200 (c) Conditions of use in dogs and cats— pounds: 1 fluid ounce; for animals (1) Amount—(i) Dogs. Administer 5 mg weighing 200 to 300 pounds: 1 1⁄2 fluid per pound (/lb) of body weight orally, ounces; for animals weighing 300 to 450 twice daily. In severe infections, ad- pounds: 2 fluid ounces; for animals minister 5 mg/lb three times daily, or weighing 450 to 700 pounds: 3 fluid up to 10 mg/lb twice daily. For stub- ounces; for animals weighing 700 to born urinary tract infections, admin- 1,000 pounds: 4 fluid ounces; for animals ister up to 20 mg/lb twice daily. weighing 1,000 to 1,200 pounds: 5 fluid (ii) Cats. Administer 50 mg twice ounces; for animals weighing over 1,200 daily. pounds: 6 fluid ounces. Retreat in 3 to (2) Indications for use. For the treat- 4 weeks. ment of respiratory tract infections, (2) Indications for use. For control of urinary tract infections, gastro- gastrointestinal roundworms of the genera Haemonchus, Ostertagia, intestinal infections, skin infections, Trichostrongylus, and Cooperia. soft tissue infections, and postsurgical (3) Limitations. Do not treat dairy infections associated with strains of or- animals of breeding age. Do not treat ganisms susceptible to hetacillin po- within 1 week of slaughter. tassium. (3) Limitations. Federal law restricts [40 FR 13838, Mar. 27, 1975, as amended at 45 this drug to use only by or on the order FR 10333, Feb. 15, 1980; 46 FR 48642, Oct. 2, of a licensed veterinarian. 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997; 78 FR 28822, May 20, 2014] [75 FR 10166, Mar. 5, 2010]

§ 520.1120b Haloxon boluses. § 520.1156 Imidacloprid. (a) Specifications. Each bolus contains (a) Specifications. Each chewable tab- 10.1 grams of haloxon. let contains 7.5 or 37.5 milligrams (mg) (b) Sponsor. See No. 000061 in imidacloprid. § 510.600(c) of this chapter. (b) Sponsor. See No. 000859 in (c) Related tolerances. See § 556.310 of § 510.600(c) of this chapter. this chapter. (c) Conditions of use in dogs—(1) (d) Conditions of use in cattle—(1) Amount. Administer daily one 7.5-mg Amount. Administered one bolus per 500 chewable tablet to dogs weighing 4 to pounds body weight (35 to 50 milligrams per kilogram of body weight). 22 pounds (lb) or one 37.5-mg chewable Retreat in 3 to 4 weeks. table to dogs weighing 23 to 110 lb. (2) Indications for use. For control of (2) Indications for use. Kills adult fleas gastrointestinal roundworms of the and is indicated for the treatment of genera Haemonchus, Ostertagia, flea infestations on dogs and puppies 10 Trichostrongylus, and Cooperia. weeks of age and older and weighing 4 (3) Limitations. Do not treat dairy lb or greater. animals of breeding age or older. Do (3) Limitations. Do not give to puppies not treat within 1 week of slaughter. younger than 10 weeks of age or to dogs weighing less than 4 lb. Do not give [40 FR 13838, Mar. 27, 1975, as amended at 44 FR 61591, Oct. 29, 1979; 46 FR 48642, Oct. 2, more than one tablet a day. 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, [80 FR 18775, Apr. 8, 2015] Nov. 19, 1997; 78 FR 28822, May 20, 2014]

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§ 520.1157 Iodinated casein. § 520.1189 Itraconazole. (a) Specifications. Each 1-gram tablet (a) Specifications. Each milliliter contains 25 milligrams of iodinated ca- (mL) of solution contains 10 milligrams sein. (mg) of itraconazole. (b) Sponsor. See No. 017762 in (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. 1⁄5 to (c) Conditions of use—(1) Amount. Ad- 1 tablet per 10 pounds of body weight minister 5 mg/kilogram (kg) (0.5 mL/ (equivalent to 0.5 to 2.5 milligrams of kg) of body weight once daily on alter- iodinated casein per pound of body nating weeks for 3 treatment cycles. weight). (2) Indications for use. For the treat- (2) Indications for use. For dogs for ap- ment of dermatophytosis caused by parent decreased thyroid activity Microsporum canis in cats. where the signs are alopecia, scaliness (3) Limitations. Federal law restricts of the skin surface, loss of hair, sebor- this drug to use by or on the order of a rhea, thickening of the skin, licensed veterinarian. hyperpigmentation, and lethargy. (3) Limitations. Federal law restricts [82 FR 12169, Mar. 1, 2017] this drug to use by or on the order of a § 520.1192 Ivermectin paste. licensed veterinarian. (a) Specifications. Each milligram [49 FR 22469, May 30, 1984, as amended at 78 (mg) of paste contains 0.0187 mg (1.87 FR 28822, May 20, 2014] percent) or 0.00153 mg (0.153 percent) of § 520.1158 Iodochlorhydroxyquin. ivermectin. (b) Sponsors. See sponsors in (a) Specifications. Each bolus contains § 510.600(c) of this chapter for use as in 10 grams of iodochlorhydroxyquin. paragraph (e) of this section: (b) Sponsor. See No. 054771 in § 510.600 (1) No. 050604 for use of a 1.87 percent (c) of this chapter. paste as in (e)(1) of this section and a (c) Conditions of use—(1) Amount. 1 0.153 percent paste for use as in para- bolus (10 grams) daily for a 1,000-pound graph (e)(2) of this section. horse. (2) Indications for use. For treatment (2) Nos. 000859, 051311, 054925, and of equine diarrhea. 061623 for use of a 1.87 percent paste for (3) Limitations. Do not use in horses use as in paragraph (e)(1) of this sec- intended for human consumption. Fed- tion. eral law restricts this drug to use by or (c) Related tolerances. See § 556.344 of on the order of a licensed veterinarian. this chapter. (d) Special considerations. See § 500.25 [48 FR 8054, Feb. 25, 1983, as amended at 50 of this chapter. FR 41489, Oct. 11, 1985; 78 FR 28822, May 20, (e) Conditions of use—(1) Horses—(i) 2014] Amount. 200 micrograms per kilogram § 520.1182 Iron dextran suspension. (91 micrograms per pound) of body weight. (a) Specifications. Each milliliter (ii) Indications for use. For treatment (mL) of suspension contains 55.56 milli- and control of Large Strongyles grams (mg) iron as ferric hydroxide in (adults): Strongylus vulgaris (also early complex with a low molecular weight forms in blood vessels), S. edentatus dextran. (also tissue stages), S. equinus, (b) Sponsor. See No. 051311 in Triodontophorus spp. including T. § 510.600(c) of this chapter. brevicauda and T. serratus, and (c) Conditions of use in swine—(1) Craterostomum acuticaudatum; Small Amount. Administer 100 mg (1.8 mL) Strongyles (adults, including those re- orally by automatic dose dispenser. sistant to some benzimidazole class (2) Indications for use. For the preven- compounds): Coronocyclus spp. includ- tion of iron deficiency anemia in baby ing C. coronatus, C. labiatus, and C. pigs. labratus, Cyathostomum spp. including (3) Limitations. Treat each pig within C. catinatum and C. pateratum, 24 hours of farrowing. Cylicocyclus spp. including C. insigne, C. [70 FR 32489, June 3, 2005] leptostomum, C. nassatus, and C.

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brevicapsulatus, Cylicodontophorus spp., § 520.1193 Ivermectin tablets and Cylicostephanus spp. including C. chewables. calicatus, C. goldi, C. longibursatus, and (a) Specifications. (1) Each tablet or C. minutus, and Petrovinema poculatum; chewable contains 68, 136, or 272 Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth-stage lar- micrograms (mcg) ivermectin. vae): Oxyuris equi; Ascarids (adults and (2) Each chewable contains 55 or 165 third- and fourth-stage larvae): mcg ivermectin. Parascaris equorum; Hairworms (adults): (b) Sponsors. See sponsors in Trichostrongylus axei; Large mouth § 510.600(c) of this chapter for use as in Stomach Worms (adults): Habronema paragraph (d) of this section. muscae; Bots (oral and gastric stages): (1) No. 050604 for use of tablets or Gasterophilus spp. including G. chewables described in paragraph (a)(1) intestinalis and G. nasalis; Lungworms as in paragraph (d)(1) and chewables de- (adults and fourth-stage larvae): scribed in paragraph (a)(2) as in para- Dictyocaulus arnfieldi; Intestinal graph (d)(2) of this section. Threadworms (adults): Strongyloides (2) Nos. 051311 and 069043 for use of westeri; Summer Sores caused by tablets described in paragraph (a)(1) as Habronema and Draschia spp. cutaneous in paragraph (d)(1) of this section. third-stage larvae; Dermatitis caused (c) Special considerations. Federal law by neck threadworm microfilariae, restricts this drug to use by or on the Onchocerca sp. (iii) Limitations. For oral use only. Do order of a licensed veterinarian. not use in horses intended for human (d) Conditions of use—(1) Dogs. For use consumption. in dogs 6 weeks of age and older as fol- (2) Cattle—(i) Amount. 23 milligrams lows: per 250 pounds of body weight. (i) Amount. 6.0 mcg per kilogram (kg) (ii) Indications for use. It is used in of body weight (2.72 mcg per pound cattle for the treatment and control of (lb)), minimum. Up to 25 lb, 68 mcg; 26 gastrointestinal roundworms (adults to 50 lb, 136 mcg; 51 to 100 lb, 272 mcg; and fourth-stage larvae) (Ostertagia over 100 lb, a combination of the appro- ostertagi (including inhibited forms), O. priate tablets. Administer at monthly lyrata, Haemonchus placei, dosing intervals. Trichostrongylus axei, T. colubriformis, (ii) Indications for use. To prevent ca- Cooperia oncophora, C. punctata, nine heartworm disease by eliminating Nematodirus helvetianus, Bunostomum the tissue stage of heartworm larvae phlebotomum, Strongyloides papillosus (Dirofilaria immitis) for 1 month (30 (adults only), Oesophagostomum days) after infection. radiatum, Trichuris ovis (adults only)); lungworms (adults and fourth-stage (2) Cats. For use in cats 6 weeks of larvae) (Dictyocaulus viviparus); grubs age and older as follows: (first, second, and third instars) (i) Amount. Up to 2.3 kilograms (up to (Hypoderma bovis, H. lineatum); and 5 lb), 55 mcg; 2.3 to 6.8 kilograms (5 to sucking lice (Linognathus vituli, 15 lb), 165 mcg; over 6.8 kilograms (15 Haematopinus eurysternus). lb), a combination of the appropriate (iii) Limitations. For oral use only. Do chewables (recommended minimum not treat cattle within 24 days of dose of 24 mcg/kg of body weight (10.9 slaughter. Because withdrawal time in mcg/lb)). Administer once a month. milk has not been established, do not (ii) Indications for use. To prevent fe- use in female dairy cattle of breeding line heartworm disease by eliminating age. the tissue stage of heartworm larvae [49 FR 22275, May 29, 1984, as amended at 50 Dirofilaria immitis for a month (30 days) FR 27819, July 8, 1985; 51 FR 44449, Dec. 10, after infection, and for removal and 1986; 53 FR 51273, Dec. 21, 1988; 62 FR 63270, control of adult and immature (L4) Nov. 28, 1997; 65 FR 70661, Nov. 27, 2000; 67 FR hookworms Ancylostoma tubaeforme and 71820, Dec. 3, 2002; 68 FR 43294, July 22, 2003; A. braziliense. 69 FR 59131, Oct. 4, 2004; 70 FR 8514, Feb. 22, 2005; 71 FR 40010, July 14, 2006; 71 FR 67298, [67 FR 11230, Mar. 13, 2002, as amended at 67 Nov. 21, 2006; 73 FR 34184, June 17, 2008; 74 FR FR 21996, May 2, 2002; 69 FR 43735, July 22, 6542, Feb. 10, 2009; 78 FR 17596, Mar. 22, 2013] 2004; 81 FR 17607, Mar. 30, 2016]

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§ 520.1194 Ivermectin meal. § 520.1195 Ivermectin liquid. (a) Specifications. Each gram of meal (a) Specifications—(1) Each milliliter contains 6 milligrams ivermectin (0.6 (mL) contains 10 milligrams (mg) percent). ivermectin. (b) Sponsor. See No. 017135 in (2) Each mL of micellar solution con- § 510.600(c) of this chapter. tains 0.8 mg ivermectin. (b) Sponsors. See sponsor numbers in (c) Special considerations. See § 500.25 § 510.600(c) of this chapter. of this chapter. (1) Nos. 000859, 050604, 054925, and (d) Conditions of use in horses—(1) 058005 for use of product described in Amount. Administer 136 micrograms paragraph (a)(1) of this section as in (mcg) ivermectin per pound (/lb) body paragraphs (e)(1)(i), (e)(1)(ii)(A), and weight (300 mcg/kilogram) as a single (e)(1)(iii) of this section. dose on approximately 2 lb grain or (2) No. 058829 for use of product de- sweet feed. scribed in paragraph (a)(1) of this sec- (2) Indications for use. For treatment tion as in paragraphs (e)(1)(i), and control of Large Strongyles (e)(1)(ii)(B), and (e)(1)(iii) of this sec- (adults): Strongylus vulgaris (also early tion. forms in blood vessels), S. edentatus (3) Nos. 050604 and 058829 for use of (also tissue stages), S. equinus, product described in paragraph (a)(2) of Triodontophorus spp. including T. this section as in paragraph (e)(2) of brevicauda and T. serratus, and this section. Craterostomum acuticaudatum; Small (c) Related tolerances. See § 556.344 of Strongyles (adults, including those re- this chapter. sistant to some benzimidazole class (d) Special considerations. See § 500.25 of this chapter. compounds): Coronocyclus spp. includ- (e) Conditions of use—(1) Horses—(i) ing C. coronatus, C. labiatus, and C. Amount. 200 micrograms (mcg) per kilo- labratus, Cyathostomum spp. including gram (/kg) of body weight as a single C. catinatum and C. pateratum, dose by stomach tube or as an oral Cylicocyclus spp. including C. insigne, C. drench. leptostomum, C. nassatus, and C. (ii) Indications for use. For treatment brevicapsulatus, Cylicodontophorus spp., and control of: Cylicostephanus spp. including C. (A) Large Strongyles (adults): calicatus, C. goldi, C. longibursatus, and Strongylus vulgaris (also early forms in C. minutus, and Petrovinema poculatum; blood vessels), S. edentatus (also tissue Small Strongyles (fourth-stage larvae); stages), S. equinus, Triodontophorus spp. Pinworms (adults and fourth stage lar- including T. brevicauda and T. serratus, vae): Oxyuris equi; Ascarids (adults and and Craterostomum acuticaudatum; third- and fourth-stage larvae): Small Strongyles (adults, including Parascaris equorum; Hairworms (adults): those resistant to some benzimidazole Trichostrongylus axei; Large Mouth class compounds): Coronocyclus spp. in- Stomach Worms (adults): Habronema cluding C. coronatus, C. labiatus, and C. muscae; Bots (oral and gastric stages): labratus, Cyathostomum spp. including Gasterophilus spp. including G. C. catinatum and C. pateratum, intestinalis and G. nasalis; Lungworms Cylicocyclus spp. including C. insigne, C. (adults and fourth-stage larvae): leptostomum, C. nassatus, and C. Dictyocaulus arnfieldi; Intestinal brevicapsulatus, Cylicodontophorus spp., Threadworms (adults): Strongyloides Cylicostephanus spp. including C. westeri; Summer Sores caused by calicatus, C. goldi, C. longibursatus, and Habronema and Draschia spp. cutaneous C. minutus, and Petrovinema poculatum; third-stage larvae; Dermatitis caused Small Strongyles (fourth-stage larvae); by neck threadworm microfilariae, Pinworms (adults and fourth stage lar- Onchocerca sp. vae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Limitations. Do not use in horses in- Parascaris equorum; Hairworms (adults): tended for human consumption. Trichostrongylus axei; Large mouth [70 FR 1817, Jan. 11, 2005, as amended at 70 Stomach Worms (adults): Habronema FR 19262, Apr. 13, 2005] muscae; Bots (oral and gastric stages):

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Gasterophilus spp. including G. (iii) Limitations. For use in sheep intestinalis and G. nasalis; Lungworms only. Do not use in other animal spe- (adults and fourth-stage larvae): cies as severe adverse reactions, in- Dictyocaulus arnfieldi; Intestinal cluding fatalities in dogs, may result. Threadworms (adults), Strongyloides Do not treat sheep within 11 days of westeri; Summer Sores caused by slaughter. Habronema and Draschia spp. cutaneous [67 FR 50597, Aug. 5, 2002, as amended at 69 third-stage larvae; Dermatitis caused FR 57173, Sept. 24, 2004; 71 FR 13542, Mar. 16, by neck threadworm microfilariae, 2006; 71 FR 38072, July 5, 2006; 72 FR 9456, Feb. Onchocerca sp. 21, 2008; 78 FR 17596, Mar. 22, 2013; 79 FR 10964, (B) Large Strongyles (Strongylus Feb. 27, 2014] equinus (adult), S. vulgaris (adult and arterial larval stages), S. endentatus § 520.1196 Ivermectin and pyrantel (adult and migrating tissue stages), tablets. Triodontophorus spp. (adult)); Small (a) Specifications. Each chewable tab- Strongyles including those resistant to let contains either 68 micrograms (μg) some benzimidazole class compounds of ivermectin and 57 milligrams (mg) of (Cyathostomum spp. (adult and fourth- pyrantel (as pamoate salt), or 136 μg stage larvae), Cylicocyclus spp., and 114 mg, or 272 μg and 227 mg, re- Cylicodontophorus spp., Cylicostephanus spectively. spp.); Pinworms (Oxyuris equi (adult (b) Sponsors. See Nos. 050604, 051311, and fourth-stage larvae)); Ascarids and 063604 in § 510.600(c) of this chapter. (Parascaris equorum (adult and third- (c) Conditions of use—(1) Dogs—(i) and fourth-stage larvae)); Hairworms Amount. Administer a minimum of 6 μg (Trichostongylus axei ( adult)); Large of ivermectin and 5 mg of pyrantel per mouth Stomach Worms (Habronema kilogram (2.72 μg and 2.27 mg per muscae (adult)); Stomach Bots pound) of body weight monthly. (Gastrophilus spp. (oral and gastric (ii) Indications for use. To prevent ca- stages)); Lungworms (Dictyocaulus nine heartworm disease by eliminating arnfieldi (adult and fourth-stage lar- the tissue larval stages of Dirofilaria vae)); intestinal threadworms immitis for up to a month (30 days) after (Strongyloides westeri (adult)); Summer infection and treatment and control of Sores caused by Habronema and adult ascarids Toxocara canis and Draschia spp. cutaneous third-stage lar- Toxascaris leonina, and adult vae; and Dermatitis caused by neck hookworms Ancylostoma caninum, A. threadworm microfilariae (Onchocerca braziliense, and Uncinaria stenocephala. spp.). (iii) Limitations. Federal law restricts (iii) Limitations. Do not use in horses this drug to use by or on the order of a intended for human consumption. Fed- licensed veterinarian. eral law restricts this drug to use by or (2) [Reserved] on the order of a licensed veterinarian. [58 FR 8542, Feb. 16, 1993, as amended at 61 (2) Sheep—(i) Amount. 200 mcg/kg (3 FR 15186, Apr. 5, 1996; 61 FR 59004, Nov. 20, mL/26 pounds) of body weight as a sin- 1996; 62 FR 63270, Nov. 28, 1997; 66 FR 35756, gle dose oral drench. July 9, 2001; 67 FR 21996, May 2, 2002; 68 FR (ii) Indications for use. For treatment 55823, Sept. 29, 2003; 78 FR 28822, May 20, 2014] and control of the adult and fourth- stage larvae of gastrointestinal § 520.1197 Ivermectin sustained-re- roundworms (Haemonchus contortus, H. lease bolus. placei (adults only), Ostertagia (a) Specifications. Each sustained-re- circumcincta, Trichostrongylus axei, T. lease bolus contains 1.72 grams of colubriformis, Cooperia oncophora ivermectin. (adults only), C. curticei, (b) Sponsor. See No. 050604 in Oesophagostomum columbianum, O. § 510.600(c) of this chapter. venulosum (adults only), Nematodirus (c) Related tolerances. See § 556.344 of battus, N. spathiger, S. papillosus (adults this chapter. only), Chabertia ovina (adult only), (d) Conditions of use in ruminating Trichuris ovis (adults only)); lungworms calves—(1) Amount. Administer one (D. filaria); and all larval stages of the bolus per calf weighing at least 275 nasal bot Oestrus ovis. pounds (lb) (125 kilograms (kg)) and not

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more than 660 lb (300 kg) on the day of (3) No. 050604 for use of products de- administration. scribed in paragraph (a)(3) of this sec- (2) Indications. For treatment and tion as in paragraphs (d)(1)(iii), control, throughout the grazing season (d)(2)(iii) and (d)(3) of this section. (approximately 130 days), of gastro- (c) Special considerations. See § 500.25 intestinal roundworms Haemonchus of this chapter. placei, Ostertagia ostertagi (including in- (d) Conditions of use in horses—(1) hibited fourth-stage larvae), Amount—(i) 200 micrograms (mcg) per Trichostrongylus axei, T. colubriformis, kilogram (/kg) ivermectin (91 mcg per Cooperia spp., Nematodirus helvetianus, pound (/lb)) and 1 mg/kg praziquantel Bunostomum phlebotomum, (454 mcg/lb) body weight. Oesophagostomum radiatum; lungworms (ii) 200 mcg/kg ivermectin (91 mcg/lb) Dictyocaulus viviparus; grubs Hypoderma and 1.5 mg/kg praziquantel (681 mcg/lb) spp.; sucking lice Linognathus vituli, body weight. Solenopotes capillatus; mange mites (iii) 200 mcg/kg ivermectin (91 mcg/lb) Psoroptes ovis, Sarcoptes scabiei, and and 2.5 mg/kg praziquantel (1.14 mg/lb). ticks Amblyomma americanum. (2) Indications for use—(i) For treat- (3) Limitations. The bolus was specifi- ment and control of the following cally designed for use in cattle; do not parasites: Tapeworms—Anoplocephala use in other animal species. Calves perfoliata; Large Strongyles (adults)— must be ruminating and older than 12 Strongylus vulgaris (also early forms in weeks of age. Do not administer to blood vessels), S. edentatus (also tissue calves weighing less than 275 lb (125 stages), S. equinus, Triodontophorus spp. kg). Do not administer a damaged including T. brevicauda and T. serratus, bolus. Because a milk withdrawal time and Craterostomum acuticaudatum; has not been established, do not use in Small Strongyles (adults, including female dairy cattle of breeding age. Do those resistant to some benzimidazole not slaughter cattle within 180 days of class compounds)—Coronocyclus spp. in- treatment. Consult your veterinarian cluding C. coronatus, C. labiatus, and C. for assistance in the diagnosis, treat- labratus; Cyathostomum spp. including ment, and control of parasitism. C. catinatum and C. pateratum; [61 FR 67452, Dec. 23, 1996, as amended at 62 Cylicocyclus spp. including C. insigne, C. FR 63270, Nov. 28, 1997; 65 FR 45876, July 26, leptostomum, C. nassatus, and C. 2000] brevicapsulatus; Cylicodontophorus spp.; Cylicostephanus spp. including C. § 520.1198 Ivermectin and praziquantel calicatus, C. goldi, C. longibursatus, and paste. C. minutus, and Petrovinema poculatum; (a) Specifications. Each milligram Small Strongyles—fourth-stage larvae; (mg) of paste contains: Pinworms (adults and fourth-stage lar- (1) 0.0155 mg (1.55 percent) ivermectin vae)—Oxyuris equi; Ascarids (adults and and 0.0775 mg (7.75 percent) third- and fourth-stage larvae)— praziquantel. Parascaris equorum; Hairworms (2) 0.0187 mg (1.87 percent) ivermectin (adults)—Trichostrongylus axei; Large- and 0.1403 mg (14.03 percent) mouth Stomach Worms (adults)— praziquantel. Habronema muscae; Bots (oral and gas- (3) 0.0187 mg (1.87 percent) ivermectin tric stages)—Gasterophilus spp. includ- and 0.2338 mg (23.38 percent) ing G. intestinalis and G. nasalis; praziquantel. Lungworms (adults and fourth-stage (b) Sponsors. See sponsors in larvae)—Dictyocaulus arnfieldi; Intes- § 510.600(c) of this chapter for uses as in tinal Threadworms (adults)— paragraph (d) of this section.— Strongyloides westeri; Summer Sores (1) No. 050604 for use of product de- caused by Habronema and Draschia spp. scribed in paragraph (a)(1) of this sec- cutaneous third-stage larvae; Derma- tion as in paragraphs (d)(1)(i), (d)(2)(i) titis caused by neck threadworm and (d)(3) of this section. microfilariae of Onchocerca sp. (2) No. 051311 for use of product de- (ii) For treatment and control of the scribed in paragraph (a)(2) of this sec- following parasites: Tapeworms— tion as in paragraphs (d)(1)(ii), Anoplocephala perfoliata; Large (d)(2)(ii), and (d)(3) of this section. Strongyles (adults)—Strongylus vulgaris

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(also early forms in blood vessels), S. tinal Threadworms (adults)— edentatus (also tissue stages), S. Strongyloides westeri; Summer Sores equinus, Triodontophorus spp.; Small caused by Habronema and Draschia spp. Strongyles (adults, including those re- cutaneous third-stage larvae; Derma- sistant to some benzimidazole class titis caused by neck threadworm compounds)—Cyathostomum spp.; microfilariae of Onchocerca sp. Cylicocyclus spp.; Cylicostephanus spp., (3) Limitations. For oral use only. Do Cylicodontophorus spp.; Small not use in horses intended for human Strongyles—fourth-stage larvae; consumption. Pinworms (adults and fourth-stage larvae)—Oxyuris equi; Ascarids (adults and [68 FR 55309, Sept. 25, 2003, as amended at 69 third- and fourth-stage larvae)— FR 49808, Aug. 12, 2004; 70 FR 65835, Nov. 1, 2005; 79 FR 37619, July 2, 2014] Parascaris equorum; Hairworms (adults)—Trichostrongylus axei; Large- § 520.1199 Ivermectin, pyrantel, and mouth Stomach Worms (adults)— praziquantel tablets. Habronema muscae; Bots (oral and gastric stages)—Gasterophilus spp.; (a) Specifications. Each chewable tab- Lungworms (adults and fourth-stage let contains: larvae)—Dictyocaulus arnfieldi; Intes- (1) 34 micrograms (mcg) ivermectin, tinal Threadworms (adults)— 28.5 milligrams (mg) pyrantel pamoate, Strongyloides westeri; Summer Sores and 28.5 mg praziquantel; caused by Habronema and Draschia spp. (2) 68 mcg ivermectin, 57 mg pyrantel cutaneous third-stage larvae; Derma- pamoate, and 57 mg praziquantel; titis caused by neck threadworm (3) 136 mcg ivermectin, 114 mg microfilariae, Onchocerca sp. pyrantel pamoate, and 114 mg (iii) For treatment and control of the praziquantel; or following parasites in horses over 5 (4) 272 mcg ivermectin, 228 mg months of age: Tapeworms— pyrantel pamoate, and 228 mg Anoplocephala perfoliata; Large praziquantel. Strongyles (adults)—Strongylus vulgaris (b) Sponsor. See No. 051311 in (also early forms in blood vessels), S. § 510.600(c) of this chapter. edentatus (also tissue stages), S. (c) Conditions of use in dogs—(1) equinus, Triodontophorus spp. including Amount. Administer monthly according T. brevicauda and T. serratus, and to body weight as follows: Craterostomum acuticaudatum; Small (i) 6 to 12 lb: one tablet as described Strongyles (adults, including those rein paragraph (a)(1) of this section. sistant to some benzimidazole class (ii) 12.1 to 25 lb: one tablet as de- compounds)—Coronocyclus spp. includ- scribed in paragraph (a)(2) of this sec- ing C. coronatus, C. labiatus, and C. tion. labratus; Cyathostomum spp. including C. catinatum and C. pateratum; (iii) 25.1 to 50 lb: one tablet as de- Cylicocyclus spp. including C. insigne, C. scribed in paragraph (a)(3) of this sec- leptostomum, C. nassatus, and C. tion. brevicapsulatus; Cylicodontophorus spp.; (iv) 50.1 to 100 lb: one tablet as de- Cylicostephanus spp. including C. scribed in paragraph (a)(4) of this sec- calicatus, C. goldi, C. longibursatus, and tion. C. minutus, and Petrovinema poculatum; (v) Greater than 100 lb: use the appro- Small Strongyles—fourth-stage larvae; priate combination of tablets. Pinworms (adults and fourth-stage lar- (2) Indications for use. Prevents ca- vae)—Oxyuris equi; Ascarids (adults and nine heartworm disease by eliminating third- and fourth-stage larvae)— the tissue stage of heartworm larvae Parascaris equorum; Hairworms (Dirofilaria immitis) for 1 month (30 (adults)—Trichostrongylus axei; Large- days) after infection and for the treat- mouth Stomach Worms (adults)— ment and control of roundworm Habronema muscae; Bots (oral and gas- (Toxocara canis, Toxascaris leonina), tric stages)—Gasterophilus spp. includ- hookworm (Ancylostoma caninum, ing G. intestinalis and G. nasalis; Uncinaria stenocephala, Ancylostoma Lungworms (adults and fourth-stage braziliense) and tapeworm (Dipylidium larvae)—Dictyocaulus arnfieldi; Intes- caninum, Taenia pisiformis) infections.

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(3) Limitations. Federal law restricts (2) Indications for use. For the treat- this drug to use by or on the order of a ment of bacterial enteritis caused by licensed veterinarian. organisms susceptible to kanamycin [71 FR 65052, Nov. 7, 2006, as amended at 78 and the symptomatic relief of the asso- FR 28822, May 20, 2014] ciated diarrhea. (3) Limitations. Federal law restricts § 520.1200 Ivermectin, fenbendazole, this drug to use by or on the order of a and praziquantel tablets. licensed veterinarian. (a) Specifications. Each chewable tab- [40 FR 13838, Mar. 27, 1975, as amended at 53 let contains either: FR 27851, July 25, 1988; 56 FR 8710, Mar. 1, (1) 68 micrograms (μg) ivermectin, 1991; 64 FR 403, Jan. 5, 1999; 71 FR 43968, Aug. 1.134 grams fenbendazole, and 57 milli- 3, 2006; 78 FR 28822, May 20, 2014] grams (mg) praziquantel; or (2) 27 μg ivermectin, 454 mg § 520.1242 Levamisole. fenbendazole, and 23 mg praziquantel. (b) Sponsor. See No. 000061 in § 520.1242a Levamisole powder. § 510.600(c) of this chapter. (a) Specifications. Each package of (c) Conditions of use in dogs—(1) powder contains 9.075, 11.7, 18.15, 46.8, Amount. Administer tablets to provide 362.7, or 544.5 grams (g) levamisole hy- μ 6 g per kilogram (/kg) ivermectin, 100 drochloride. mg/kg fenbendazole, and 5 mg/kg (b) Sponsors. See sponsors in praziquantel. § 510.600(c) for use as follows: (2) Indications for use. For the treat- (1) No. 000061 for use of 46.8- and 544.5- ment and control of adult Toxocara g packages as in paragraph (e)(1)(i), canis (roundworm), Ancylostoma (e)(1)(ii)(B), and (e)(1)(iii) of this sec- caninum (hookworm), Trichuris vulpis (whipworm), and Dipylidium caninum tion; for 11.7-, 46.8-, and 544.5-g pack- (tapeworm), and for the prevention of ages as in paragraph (e)(2)(i), heartworm disease caused by Dirofilaria (e)(2)(ii)(B), and (e)(2)(iii) of this sec- immitis in adult dogs. tion; and for an 18.15-g package as in (3) Limitations. Federal law restricts paragraph (e)(3) of this section. this drug to use by or on the order of a (2) No. 054771 for use of a 46.8-g pack- licensed veterinarian. age as in paragraph (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this sec- [73 FR 33692, June 13, 2008, as amended at 74 tion; for 11.7- and 46.8-g packages as in FR 61516, Nov. 25, 2009] paragraph (e)(2)(i), (e)(2)(ii)(A), and § 520.1204 Kanamycin, bismuth subcar- (e)(2)(iii) of this section; and for 9.075- bonate, activated attapulgite. and 18.15-g packages as in paragraph (e)(3) of this section. (a) Specifications—(1) Each 5 milli- (3) No. 057561 for use of 46.8- and 544.5- liters (mL) of suspension contains 100 milligrams (mg) kanamycin (as the g packages as in paragraphs (e)(1)(i), sulfate), 250 mg bismuth subcarbonate, (e)(1)(ii)(A), and (e)(1)(iii) and (e)(2)(i), and 500 mg activated attapulgite (alu- (e)(2)(ii)(A), and (e)(2)(iii) of this sec- minum magnesium silicate). tion. (2) Each tablet contains 100 mg (4) No. 059130 for use of 46.8-, 362.7-, kanamycin (as the sulfate), 250 mg bis- and 544.5-g packages as in paragraphs muth subcarbonate, and 500 mg acti- (e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i), vated attapulgite. (e)(2)(ii)(B), and (e)(2)(iii) of this sec- (b) Sponsor. See No. 054771 in tion; and for use of an 18.15-g package § 510.600(c) of this chapter. as in paragraph (e)(3) of this section. (c) Conditions of use in dogs—(1) (c) Related tolerances. See § 556.350 of Amount. 5 mL of suspension or 1 tablet this chapter. per 20 pounds body weight every 8 (d) Special considerations. See § 500.25 hours. Maximum dose: 5 mL of suspen- of this chapter. sion or 3 tablets every 8 hours. Dogs (e) Conditions of use. It is used as an under 10 pounds: 2.5 mL of suspension anthelmintic as follows: or 1⁄2 tablet every 8 hours. A rec- (1) Cattle—(i) Amount. 8 milligrams ommended initial loading dose should per kilogram (mg/kg) body weight as a be twice the amount of a single dose. drench.

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(ii) Indications for use—(A) Effective (Oesophagostomum spp.), intestinal against the following nematode infec- thread worms (Strongyloides ransomi) tions: Stomach worms (Haemonchus, and lungworms (Metastrongylus spp. ). Trichostrongylus, Ostertagia); intestinal (iii) Limitations. Do not administer worms (Trichostrongylus, Cooperia, within 72 hours of slaughter for food. Nematodirus, Bunostomum, Pigs maintained under conditions of Oesophagostomum); and lungworms constant exposure to worms may re- (Dictyocaulus). quire retreatment within 4 to 5 weeks (B) Effective against the following after the first treatment. Consult your adult nematode infections: Stomach veterinarian before administering to worms (Haemonchus placei, Ostertagia sick swine. ostertagi, Trichostrongylus axei); intes- [69 FR 9753, Mar. 2, 2004, as amended at 69 FR tinal worms (T. longispicularis, Cooperia 33839, June 17, 2004; 70 FR 2353, Jan. 13, 2005; oncophora, C. punctata, Nematodirus 77 FR 28253, May 14, 2012; 78 FR 28822, May 20, spathiger, Bunostomum phlebotomum, 2014] Oesophagostomum radiatum); and lungworms (Dictyocaulus viviparus). § 520.1242b Levamisol boluses or (iii) Limitations. Do not slaughter for oblets. food within 48 hours of treatment. Not (a) Specifications. Each bolus contains for use in dairy animals of breeding 2.19 grams levamisol hydrochloride. age. Conditions of constant helminth Each oblet contains 0.184 grams exposure may require retreatment 2 to levamisol hydrochloride. 4 weeks after the first treatment. Con- (b) Sponsors. See Nos. 000061 and sult your veterinarian before using in 054771 in § 510.600(c) of this chapter. severely debilitated animals. (c) Required labeling. Consult your (2) Sheep—(i) Amount. 8 mg/kg body veterinarian for assistance in the diag- weight as a drench. nosis, treatment, and control of para- (ii) Indications for use—(A) Effective sitism. against the following nematode infec- (d) Related tolerances. See § 556.350 of tions: Stomach worms (Haemonchus, this chapter. Trichostrongylus, Ostertagia); intestinal (e) Conditions of use—(1) Cattle—(i) worms (Trichostrongylus, Cooperia, Amount. Administer orally 2.19-gram Nematodirus, Bunostomum, boluses as a single dose as follows: 250 Oesophagostomum, Chabertia); and to 450 pounds, 1⁄2 bolus; 450 to 750 lungworms (Dictyocaulus). pounds, 1 bolus; and 750 to 1,050 pounds, (B) Effective against the following 11⁄2 boluses. adult nematode infections: Stomach (ii) Indications for use. Anthelmintic worms (Haemonchus contortus, effective against the following nema- Trichostrongylus axei, Teladorsagia tode infections: Stomach worms circumcincta); intestinal worms (Haemonchus, Trichostrongylus, (Trichostrongylus colubriformis, Cooperia Ostertagia), intestinal worms curticei, Nematodirus spathiger, (Trichostrongylus, Cooperia, Bunostomum trigonocephalum, Nematodirus, Bunostomum, Oesophagostomum columbianum, Oesophagostomum), and lungworms Chabertia ovina), and lungworms (Dictyocaulus). (Dictyocaulus filaria). (iii) Limitations. Conditions of con- (iii) Limitations. Do not slaughter for stant helminth exposure may require food within 72 hours of treatment. Con- re-treatment within 2 to 4 weeks after ditions of constant helminth exposure the first treatment. Do not slaughter may require retreatment 2 to 4 weeks for food within 48 hours of treatment. after the first treatment. Consult vet- Not for use in dairy animals of breed- erinarian before using in severely de- ing age. Consult veterinarian before bilitated animals. using in severely debilitated animals. (3) Swine—(i) Amount. 8 mg/kg body (2) Sheep—(i) Amount. Administer weight in drinking water. orally one 0.184-gram oblet for each 50 (ii) Indications for use. Effective pounds of body weight. against the following nematode infec- (ii) Indications for use. Anthelmintic tions: Large roundworms (Ascaris effective against the following nema- suum), nodular worms tode infections: Stomach worms

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(Haemonchus, Trichostrongylus, ounce (58.1 gram) packet contains Ostertagia), intestinal worms levamisole equivalent to 5.806 grams of (Trichostrongylus, Cooperia, levamisole hydrochloride. Nematodirus, Bunostomum, (b) Sponsor. See No. 043781 in Oesophagostomum, Chabertia), and § 510.600(c) of this chapter. lungworms (Dictyocaulus). (c) Related tolerances. See § 556.350 of (iii) Limitations. Conditions of con- this chapter. stant helminth exposure may require (d) Conditions of use. In swine it is re-treatment within 2 to 4 weeks after used as follows: the first treatment. Do not slaughter (1) Amount. The equivalent of 8 milli- for food within 72 hours of treatment. grams per kilogram of body weight, as Consult a veterinarian before using in a single dose, mixed in the animal’s ra- severely debilitated animals. tion. (2) Indications for use. For the re- [78 FR 28822, May 20, 2014] moval of and control of the following § 520.1242c Levamisol and piperazine. nematode infections: large roundworms (Ascaris suum), nodular worms (a) Specifications. (1) Each ounce of (Oesophagostomum spp.), lungworms solution contains 0.36 gram of (Metastrongylus spp.), intestinal levamisole hydrochloride and piper- threadworms (Strongyloides ransomi), azine dihydrochloride equivalent to 3.98 and swine kidney worms (Stephanurus grams of piperazine base. dentatum). (2) A soluble powder which when con- (3) Limitations. For pigs from weaning stituted with water contains in each to market weight, mix one 58.1-gram fluid ounce 0.45 gram of levamisole hy- packet of levamisole resinate con- drochloride and piperazine taining the equivalent of 10-percent dihydrochloride equivalent to 5.0 grams levamisole hydrochloride in 40 pounds of piperazine base. of feed and administer 1 pound of medi- (b) Sponsor. See No. 054771 in cated feed per 40 pounds of body weight § 510.600(c) of this chapter. as sole ration. For breeding swine, mix (c) Conditions of use in horses—(1) 1 packet of the 10-percent resinate in 16 Amount. Aqueous solution: administer pounds of feed and administer 1 pound by stomach tube or drench 1 fluid of medicated feed per 100 pounds of ounce per 100 pounds of body weight. body weight as sole ration. Administer Reconstituted soluble powder: admin- as single doses. Withhold regular feed ister by stomach tube 1 fluid ounce per overnight and administer medicated 125 pounds of body weight. If reinfec- feed the following morning. Do not tion occurs, re-treat animals at 6- to 8- withhold water during fasting. Do not week intervals. treat within 72 hours of slaughter. Sali- (2) Indications for use. An anthel- vation or muzzle foam may be ob- mintic effective against infections of served. The reaction will disappear a large strongyles (Strongylus vulgaris, S. short time after feeding. If pigs are in- edentatus), small strongyles fected with mature lungworms, (Cylicocercus spp., Cylicocyclus spp., coughing and vomiting may be ob- Cylicodontophorus spp., Cylicostephanus served. Consult your veterinarian for spp., Cylicotetrapedon spp.), ascarids assistance in the diagnosis, treatment, (Parascaris equorum), and pinworms and control of parasitism. (Oxyuris equi). (3) Limitations. Do not use in horses [43 FR 18171, Apr. 28, 1978, as amended at 45 intended for human consumption. Fed- FR 3574, Jan. 18, 1980] eral law restricts this drug to use by or § 520.1242e Levamisole hydrochloride on the order of a licensed veterinarian. effervescent tablets. [78 FR 28823, May 20, 2014] (a) Specifications. Each tablet contains 907 milligrams of levamisole hy- § 520.1242d Levamisole resinate. drochloride. (a) Specifications. The drug is (b) Sponsor. See No. 054771 in levamisole adsorbed on a resin, in a § 510.600(c) of this chapter. concentration equivalent to 10 percent (c) Related tolerances. See § 556.350 of levamisole hydrochloride. Each 2.05- this chapter.

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(d) Conditions of use. It is used for narian before using in severely debili- swine as follows: tated animals. (1) Amount. The equivalent of 8 milli- (2) Breeding swine—(i) Amount. Eight grams of levamisole hydrochloride per milligrams per kilogram of body kilogram of body weight, as a single weight (3.6 milligrams per pound) as a dose. single oral dose. (2) Indications for use. See (ii) Conditions of use. For treating § 520.1242a(f)(3)(ii). breeding swine infected with the fol- (3) Limitations. Withholding water lowing nematodes: Large roundworms from pigs before treatment is not nec- (Ascaris suum), nodular worms essary. Add one tablet for each 21⁄2 gal- (Oesophagostomum spp.), lungworms lons of water; mix thoroughly. Allow 1 (Metastrongylus spp.), intestinal gallon of medicated water for each 100 threadworms (Strongyloides ransomi), pounds body weight of pigs to be treat- and kidney worms (Stephanurus ed. No other source of water should be dentatus). offered. After pigs have consumed (iii) Limitations. May require retreat- medicated water, resume use of regular ment in 4 to 5 weeks. Do not use within water. Pigs maintained under condi- 11 days of slaughter for food. Consult tions of constant worm exposure may your veterinarian for assistance before require re-treatment within 4 to 5 using in severely debilitated animals weeks. Consult your veterinarian be- and in the diagnosis, treatment, and fore administering to sick swine. Con- control of parasitism. sult your veterinarian for assistance in [47 FR 22517, May 25, 1982; 47 FR 30242, July the diagnosis, treatment, and control 13, 1982, as amended at 48 FR 11429, Mar. 18, of parasitism. Do not administer with- 1983; 51 FR 29215, Aug. 15, 1986; 67 FR 63055, in 72 hours of slaughter for food. Oct. 10, 2002; 78 FR 28823, May 20, 2014] [45 FR 6087, Jan. 25, 1980, as amended at 67 § 520.1242g Levamisole resinate and FR 63055, Oct. 10, 2002; 78 FR 28823, May 20, famphur paste. 2014] (a) Specifications. The drug is a paste § 520.1242f Levamisol gel. containing 11.6 percent levamisole resinate (50 percent potency) and 23.6 per- (a) Specifications. Each gram of gel cent famphur. contains 115 milligrams (11.5 percent) (b) Sponsor. See 000061 in § 510.600(c) of levamisol hydrochloride. this chapter. (b) Sponsor. See No. 054771 in (c) Special considerations. Do not use § 510.600(c) of this chapter. any cholinesterase-inhibiting drugs, (c) Related tolerances. See § 556.350 of pesticides, insecticides, or chemicals this chapter. on cattle simultaneously or within a (d) Conditions of use—(1) Cattle—(i) few days before or after treatment with Amount. Eight milligrams of this product. levamisole hydrochloride per kilogram (d) Related tolerances. See §§ 556.273 of body weight, as a single oral dose. and 556.350 of this chapter. (ii) Indications for use. Anthelmintic (e) Conditions of use in cattle—(1) effective against the following nema- Amount. 8 milligrams of levamisole hy- tode infections: Stomach worms drochloride (equivalent) and 30 milli- (Haemonchus, Trichostrongylus, grams of famphur activity per kilo- Ostertagia), intestinal worms gram of body weight. (Trichostrongylus, Cooperia, (2) Indications for use. For treatment Nematodirus, Bunostomum, of cattle infected with the following Oesophagostomum), and lungworms parasites: Stomach worms (Dictyocaulus). (Haemonchus, Trichostrongylus, (iii) Limitations. Conditions of con- Ostertagia), intestinal worms stant helminth exposure may require (Trichostrongylus, Cooperia, re-treatment within 2 to 4 weeks after Nematodirus, Bunostomum, the first treatment; do not administer Oesophagostomum), lungworms to cattle within 6 days of slaughter for (Dictyocaulus), cattle grubs food; do not administer to dairy ani- (Hypoderma), biting lice (Bovicola), and mals of breeding age; consult veteri- sucking lice (Linognathus, Solenoptes).

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(3) Limitations. Drug is not effective ticularly streptococci and against lice eggs. Conditions of con- staphylococci. stant helminth and ectoparasitic expo- (3) Limitations. Federal law restricts sure may require retreatment within 2 this drug to use by or on the order of a to 4 weeks after first treatment. Do not licensed veterinarian. administer to cattle within 19 days of slaughter. Do not administer to dairy [78 FR 28823, May 20, 2014] animals of breeding age. Do not use in § 520.1263b [Reserved] calves less than 3 months old, or in debilitated animals. Do not treat Brah- § 520.1263c Lincomycin powder. man bulls. Consult your veterinarian for assistance in the diagnosis, treat- (a) Specifications. Each gram of solu- ment, and control of parasitism. ble powder contains lincomycin hydrochloride equivalent to 0.4 grams of lin- [53 FR 23757, June 24, 1988, as amended at 54 comycin. FR 1353, Jan. 13, 1989; 57 FR 7652, Mar. 4, 1992; (b) Sponsors. See sponsor numbers in 62 FR 55160, Oct. 23, 1997; 62 FR 61625, Nov. 19, 1997; 78 FR 28823, May 20, 2014] § 510.600(c) of this chapter as follows: (1) Nos. 016592 and 054771 for use as in § 520.1248 Levothyroxine. paragraph (d) of this section. (a) Specifications. Each tablet con- (2) Nos. 054925, 061623, and 076475 for tains 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, or use as in paragraphs (d)(1) and (d)(2) of 1.0 milligrams (mg) levothyroxine so- this section. dium. (c) Tolerances. See § 556.360 of this (b) Sponsor. See No. 061690 in chapter. § 510.600(c) of this chapter. (d) Conditions of use—(1) Swine—(i) (c) Conditions of use—(1) Amount. Ad- Amount. 250 milligrams per gallon of minister by mouth 0.1 mg/10 pounds of drinking water to provide 3.8 milli- body weight (0.022 mg/kilogram) as a grams per pound of body weight per single dose every 24 hours or as a di- day. vided dose every 12 hours. (ii) Indications for use. For the treat- (2) Indications for use. For replacement of swine dysentery (bloody ment therapy for diminished thyroid scours). function in dogs. (iii) Limitations. Discard medicated (3) Limitations. Federal law restricts drinking water if not used within 2 this drug to use by or on the order of a days. Prepare fresh stock solution licensed veterinarian. daily. Do not use for more than 10 days. If clinical signs of disease have not im- [81 FR 22523, Apr. 18, 2016] proved within 6 days, discontinue § 520.1263 Lincomycin. treatment and reevaluate diagnosis. The safety of lincomycin has not been § 520.1263a Lincomycin tablets and demonstrated in pregnant swine or syrup. swine intended for breeding. For No. (a) Specifications. (1) Each ounce of 054925: Do not slaughter swine for 6 syrup contains lincomycin hydro- days following last treatment. Federal chloride equivalent to either 25 or 50 law restricts this drug to use by or on milligrams (mg) lincomycin. the order of a licensed veterinarian. (2) Each tablet contains lincomycin (2) Chickens—(i) Amount. 64 milli- hydrochloride equivalent to either 25 grams per gallon of drinking water. or 50 mg lincomycin. (ii) Indications for use. For the control (b) Sponsor. See No. 054771 in of necrotic enteritis caused by Clos- § 510.600(c) of this chapter. tridium perfringens susceptible to linco- (c) Conditions of use in dogs and cats— mycin in broiler chickens. (1) Amount. Administer orally 10 mg per (iii) Limitations. Discard medicated pound of body weight every 12 hours, or drinking water if not used within 2 7 mg per pound of body weight every 8 days. Prepare fresh stock solution hours, for up to 12 days. daily. Administer for 7 consecutive (2) Indications for use. For infections days. Do not allow rabbits, hamsters, caused by gram-positive organisms guinea pigs, horses, or ruminants ac- which are sensitive to its action, par- cess to water containing lincomycin.

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Not for use in layer and breeder chick- per gallon of drinking water; admin- ens. Federal law restricts this drug to ister as the sole source of water for the use by or on the order of a licensed vet- first 5 to 7 days of life. erinarian. (2) Indications for use. As an aid in the (3) Honey bees—(i) Amount. Mix 100 control of airsacculitis caused by ei- milligrams lincomycin with 20 grams ther Mycoplasma synoviae or M. confectioners’/powdered sugar and dust gallisepticum susceptible to lincomycin- over the top bars of the brood chamber spectinomycin and complicated chron- once weekly for 3 weeks. ic respiratory disease (air sac infec- (ii) Indications for use. For the control tion) caused by Escherichia coli and M. of American foulbrood (Paenibacillus gallisepticum susceptible to lincomycin- larvae). spectinomycin. (iii) Limitations. The drug should be (3) Limitations. Federal law restricts fed early in the spring or late in the this drug to use by or on the order of a fall and consumed by the bees before licensed veterinarian. the main honey flow begins to avoid contamination of production honey. [69 FR 13220, Mar. 22, 2004, as amended at 70 Complete treatments at least 4 weeks FR 40881, July 15, 2005; 71 FR 71038, Dec. 8, before main honey flow. Federal law re- 2006; 77 FR 56770, Sept. 14, 2012; 78 FR 28823, stricts this drug to use by or on the May 20, 2014; 81 FR 94989, Dec. 27, 2016] order of a licensed veterinarian. § 520.1284 Liothyronine. [48 FR 3966, Jan. 28, 1983, as amended at 55 (a) Specifications. Each tablet con- FR 3209, Jan. 31, 1990; 60 FR 14217, Mar. 16, μ 1995; 62 FR 65020, Dec. 10, 1997; 64 FR 13341, tains 60 or 120 micrograms ( g) Mar. 18, 1999; 64 FR 13508, Mar. 19, 1999; 64 FR liothyronine as the sodium salt. 66382, Nov. 26, 1999; 65 FR 10705, Feb. 29, 2000; (b) Sponsor. See No. 054771 in 67 FR 17284, Apr. 10, 2002; 67 FR 71819, Dec. 3, § 510.600(c) of this chapter. 2002; 67 FR 78356, Dec. 24, 2002; 68 FR 3817, (c) Conditions of use in dogs—(1) Jan. 27, 2003; 70 FR 1818, Jan. 11, 2005; 77 FR Amount. Administer orally to dogs at 20988, Apr. 9, 2012; 77 FR 29217, May 17, 2012; μ 78 FR 28823, May 20, 2014; 81 FR 22523, Apr. 18, levels up to 12.8 g per kilogram (/kg) 2016; 81 FR 94989, Dec. 27, 2016] of body weight per day. Dosage should be adjusted according to the severity of § 520.1265 Lincomycin and the condition and the response of the spectinomycin powder. patient. Dosage at the total replace- (a) Specifications. The following salts ment level (12.8 μg/kg of body weight) of lincomycin and spectinomycin are should be considered for initiating present in a soluble powder in the ratio therapy and then titrated downward of 1 to 2 on the basis of equivalency of for optimum maintenance effect. Twice lincomycin base to equivalency of daily administration is recommended. spectinomycin base: (2) Indications for use. For treatment (1) Lincomycin hydrochloride of hypothyroidism in dogs. monohydrate and spectinomycin sul- (3) Limitations. Federal law restricts fate tetrahydrate. this drug to use by or on the order of a (2) Lincomycin hydrochloride licensed veterinarian. monohydrate and spectinomycin [78 FR 28823, May 20, 2014] dihydrochloride pentahydrate. (b) Sponsors. See sponsors in § 520.1288 Lufenuron tablets. § 510.600(c) of this chapter for use as in paragraph (d) of this section. (a) Specifications—(1) Tablets con- (1) No. 054771 for use of product de- taining 45, 90, 204.9, or 409.8 milligrams scribed in paragraph (a)(1) of this sec- (mg) lufenuron for use as in paragraphs tion. (c)(1)(i), (c)(1)(ii)(A), (c)(1)(iii), (c)(2)(i), (2) Nos. 057561, 061623, and 066104 for (c)(2)(ii)(A), and (c)(2)(iii) of this sec- use of product described in paragraph tion. (a)(2) of this section. (2) Flavored tablets containing 45, 90, (c) Tolerances. See §§ 556.360 and 204.9, or 409.8 milligrams (mg) 556.600 of this chapter. lufenuron for use as in paragraphs (d) Conditions of use in chickens—(1) (c)(1)(i), (c)(1)(ii)(A) or (c)(1)(ii)(B), and Amount. 2 grams of antibiotic activity (c)(1)(iii) of this section.

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(3) Flavored tablets containing 90 or pounds are provided the appropriate 204.9 mg lufenuron for use as in para- combination of packs. graphs (c)(2)(i), (c)(2)(ii)(A) or (2) Indications for use. For control of (c)(2)(ii)(B), and (c)(2)(iii) of this sec- flea populations. tion. (3) Limitations. For oral use in cats 6 (4) Flavored tablets containing 135 or weeks of age or older, once a month, 270 mg lufenuron for use as in para- mixed with food. Administer in con- graphs (c)(2)(i), (c)(2)(ii)(A), and junction with a full meal to ensure ade- (c)(2)(iii) of this section. quate absorption. Treat all cats in the (b) Sponsor. See No. 058198 in household to ensure maximum bene- § 510.600(c) of this chapter. fits. Because the drug has no affect on (c) Conditions of use—(1) Dogs—(i) adult fleas, the concurrent use of insec- Amount. Minimum of 10 mg lufenuron ticides that kill adults may be nec- per kilogram (4.5 mg per pound (lb)) of essary depending on the severity of the body weight, once a month. infestation. (ii) Indications for use—(A) For the [60 FR 20402, Apr. 26, 1995, as amended at 62 prevention and control of flea popu- FR 8371, Feb. 25, 1997] lations. (B) The concurrent use of flavored § 520.1310 Marbofloxacin. lufenuron tablets described in para- (a) Specifications. Each tablet con- graph (a)(2) of this section as in para- tains 25, 50, 100, or 200 milligrams (mg) graph (c)(1)(ii)(A) of this section with marbofloxacin. nitenpyram tablets as in § 520.1510(d)(1) (b) Sponsor. See No. 054771 in of this chapter is indicated to kill § 510.600(c) of this chapter. adult fleas and prevent flea eggs from (c) [Reserved] hatching. (d) Conditions of use—(1) Amount. 1.25 (iii) Limitations. For use in dogs and mg per pound (/lb) of body weight once puppies 4 weeks of age and older. daily, but may be increased to 2.5 mg/ (2) Cats—(i) Amount. Minimum of 30 lb of body weight once daily. mg lufenuron per kilogram (13.6 mg/lb) (2) Indications for use. For the treat- of body weight, once a month. ment of infections in dogs and cats as- (ii) Indications for use—(A) For the sociated with bacteria susceptible to control of flea populations. marbofloxacin. (B) The concurrent use of flavored (3) Limitations. Federal law restricts lufenuron tablets described in para- this drug to use by or on the order of a graph (a)(3) of this section as in para- licensed veterinarian. Federal law pro- graph (c)(2)(ii)(A) of this section with hibits the extralabel use of this drug in nitenpyram tablets as in § 520.1510(d)(2) food-producing animals. of this chapter is indicated to kill adult fleas and prevent flea eggs from [64 FR 39919, July 23, 1999, as amended at 66 hatching. FR 46369, Sept. 5, 2001; 78 FR 28823, May 20, 2014] (iii) Limitations. For use in cats and kittens 4 weeks of age and older. § 520.1315 Maropitant. [68 FR 51905, Aug. 29, 2003] (a) Specifications. Each tablet contains 16, 24, 60, or 160 milligrams (mg) § 520.1289 Lufenuron suspension. maropitant as maropitant citrate. (a) Specifications. Each individual (b) Sponsor. See No. 054771 in dose pack contains either 135 or 270 § 510.600(c) of this chapter. milligrams of lufenuron. (c) Conditions of use in dogs—(1) Indi- (b) Sponsor. See No. 058198 in cations for use and amount. (i) For pre- § 510.600(c) of this chapter. vention of acute vomiting in dogs 2 to (c) Conditions of use in cats—(1) 7 months of age, administer a min- Amount. Minimum of 13.6 milligrams imum dose of 2.0 mg per kilogram (/kg) per pound of body weight (30 milli- body weight once daily for up to 5 con- grams per kilogram). Recommended secutive days. dose of 135 milligrams for up to 10 (ii) For prevention of acute vomiting pounds of body weight or 270 milli- in dogs 7 months of age and older, ad- grams for 11 to 20 pounds. Cats over 20 minister a minimum dose of 2.0 mg/kg

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body weight once daily until resolution § 520.1326 Mebendazole and of acute vomiting. trichlorfon oral dosage forms. (iii) For prevention of vomiting due to motion sickness in dogs 4 months of § 520.1326a Mebendazole and age and older, administer a minimum trichlorfon powder. of 8.0 mg/kg body weight once daily for (a) Specifications. Each gram of pow- up to 2 consecutive days. der contains 83.3 milligrams of (2) Limitations. Federal law restricts mebendazole and 375.0 milligrams of this drug to use by or on the order of a trichlorofon. licensed veterinarian. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. [72 FR 9243, Mar. 1, 2007, as amended at 78 FR (c) Conditions of use in horses—(1) 28823, May 20, 2014; 80 FR 53459, Sept. 4, 2015] Amount. 8.8 milligrams of mebendazole and 40 milligrams of trichlorofon per § 520.1320 Mebendazole. kilogram of body weight. (a) Specifications. (1) Each gram of (2) Indications for use. It is used in powder contains either 40 or 166.7 milli- horses for the treatment of infections grams of mebendazole. of bots (Gastrophilus intestinalis and G. (2) Each gram of paste contains 200 nasalis), large roundworms (Parascaris milligrams of mebendazole. equorum), large strongyles (Strongylus (3) Each milliliter of suspension con- edentatus, S. equinus, S. vulgaris), small tains 33.3 milligrams of mebendazole. strongyles, and pinworms (Oxyuris (b) Sponsor. See No. 000061 in equi.) § 510.600(c) of this chapter. (3) Limitations. Do not use in horses (c) Conditions of use—(1) Horses—(i) intended for human consumption. Fed- Amount. 1 gram of mebendazole per 250 eral law restricts this drug to use by or pounds of body weight per dose, as an on the order of a licensed veterinarian. oral powder, paste or suspension. [45 FR 10759, Feb. 19, 1980, as amended at 46 (ii) Indications for use. For treatment FR 52330, Oct. 27, 1981. Redesignated at 51 FR of infections caused by large 13212, Apr. 18, 1986, as amended at 62 FR roundworms (Parascaris equorum); large 61625, Nov. 19, 1997; 78 FR 28824, May 20, 2014] strongyles (Strongylus edentatus, S. equinus, S. vulgaris); small strongyles; § 520.1326b Mebendazole and trichlorfon paste. and mature and immature (4th larval stage) pinworms (Oxyuris equi). (a) Specifications. Each gram of paste (iii) Limitations. The drug is compat- contains 100 milligrams of mebendazole ible with carbon disulfide. Do not use and 454 milligrams of trichlorfon. in horses intended for human consump- (b) Sponsor. See No. 000061 in tion. Federal law restricts this drug to § 510.600(c) of this chapter. use by or on the order of a licensed vet- (c) Conditions of use in horses—(1) erinarian. Amount. 8.8 milligrams of mebendazole (2) Dogs—(i) Amount. Administer 100 and 40 milligrams of trichlorfon per milligrams of mebendazole per 10 kilogram of body weight. pounds of body weight, once daily for 3 (2) Indications for use. It is used in days, as an oral powder by mixing with horses for treatment of infections of a small quantity of food, preferably be- bots (Gastrophilus intestinalis and G. na- fore the regular meal. salis), large roundworms (Parascaris (ii) Indications for use. The drug is equorum), large strongyles (Strongylus used for treatment of infections of edentatus, S. equinus, S. vulgaris), small roundworms (Toxocara canis), strongyles, and pinworms (Oxyuris hookworms (Ancylostoma caninum, equi). Uncinaria stenocephala), whipworms (3) Limitations. Do not administer (Trichuris vulpis), and tapeworms more than once every 30 days. Do not (Taenia pisiformis). treat sick or debilitated animals, foals under 4 months of age, or mares in the (iii) Limitations. Federal law restricts last month of pregnancy. Trichlorfon is this drug to use by or on the order of a a cholinesterase inhibitor. Do not ad- licensed veterinarian. minister simultaneously or within a [78 FR 28823, May 20, 2014] few days before or after treatment

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with, or exposure to, cholinesterase-in- § 520.1341 Megestrol. hibiting drugs, pesticides, or chemi- (a) Specifications. Each tablet con- cals. Do not administer intravenous tains 5 or 20 milligrams of megestrol anesthetics, especially muscle relax- acetate. ants, concurrently. Not for use in (b) Sponsor. See No. 000061 in horses intended for food. Consult your § 510.600(c) of this chapter. veterinarian for assistance in the diag- (c) Conditions of use in dogs—(1) nosis, treatment, and control of para- Amount. Administer orally, intact, or sitism. crushed and mixed with food as follows: [51 FR 13212, Apr. 18, 1986, as amended at 62 (i) For the postponement of estrus by FR 61625, Nov. 19, 1997; 78 FR 28824, May 20, proestrus treatment: 1 milligram per 2014] pound of body weight per day for 8 days. § 520.1330 Meclofenamic acid granules. (ii) For the postponement of estrus (a) Specifications. Each gram of gran- by anestrus treatment: 0.25 milligram ules contains 5 milligrams (5 percent) per pound of body weight per day for 32 meclofenamic acid. days. (b) Sponsor. See No. 054771 in (iii) For alleviation of false preg- § 510.600(c) of this chapter. nancy: 1 milligram per pound of body (c) Conditions of use in horses—(1) weight per day for 8 days. Amount. Administer 1 milligram per (2) Indications for use. For the post- pound of body weight (1 gram per 1000 ponement of estrus and the alleviation pounds) once daily for 5 to 7 days by of false pregnancy in female dogs. addition to the daily grain ration. (3) Limitations. Federal law restricts (2) Indications for use. For the treat- this drug to use by or on the order of a ment of acute or chronic inflammatory licensed veterinarian. diseases involving the musculoskeletal [40 FR 13838, Mar. 27, 1975, as amended at 52 system. FR 7832, Mar. 13, 1987; 78 FR 28824, May 20, (3) Limitations. Do not use in horses 2014] intended for human consumption. Fed- eral law restricts this drug to use by or § 520.1367 Meloxicam. on the order of a licensed veterinarian. (a) Specifications—(1) Each milliliter [78 FR 28824, May 20, 2014] of suspension contains 0.5 milligrams (mg) meloxicam. § 520.1331 Meclofenamic acid tablets. (2) Each milliliter of suspension contains 1.5 mg meloxicam. (a) Specifications. Each tablet contains either 10 or 20 milligrams of (b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in meclofenamic acid. paragraph (c) of this section: (b) Sponsor. See No. 054771 in (1) No. 000010 for use of the products § 510.600(c) of this chapter. described in paragraph (a) of this sec- (c) Conditions of use in dogs—(1) tion; and Amount. 1.1 milligrams per kilogram (2) Nos. 013744 and 055529 for use of (0.5 milligram per pound) daily for 5 to the product described in paragraph 7 days. (a)(2) of this section. (2) Indications for use. For the relief of (c) Conditions of use in dogs—(1) signs and symptoms of chronic inflam- Amount. Administer orally as a single matory disease involving the musculo- dose at 0.09 mg per pound (mg/lb) body skeletal system. weight (0.2 mg per kilogram (mg/kg)) (3) Limitations. Federal law restricts on the first day of treatment. For all this drug to use by or on the order of a treatment after day 1, administer 0.045 licensed veterinarian. mg/lb (0.1 mg/kg) body weight once [50 FR 43385, Oct. 25, 1985, as amended at 53 daily. FR 23390, June 22, 1988; 78 FR 28824, May 20, (2) Indications for use. For the control 2014] of pain and inflammation associated with osteoarthritis.

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(3) Limitations. Federal law restricts (2) No. 054771 for use of 1- and 4-mg this drug to use by or on the order of a tablets. licensed veterinarian. (c) Conditions of use in dogs and cats— [68 FR 42968, July 21, 2003, as amended at 69 (1) Amount. 5 to 15 pounds (lbs): 2 mg; 15 FR 69523, Nov. 30, 2004. Redesignated and to 40 lbs: 2 to 4 mg; 40 to 80 lbs: 4 to 8 amended at 78 FR 57058, Sept. 17, 2013; 80 FR mg. Administer total daily dose orally 53459, Sept. 4, 2015] in equally divided doses 6 to 10 hours apart until response is noted or 7 days § 520.1372 Methimazole. have elapsed. (a) Specifications. Each tablet con- (2) Indications for use. As an anti-in- tains 2.5 or 5 milligrams (mg) flammatory agent. methimazole. (3) Limitations. Federal law restricts (b) Sponsor. See No. 043264 in § 510.600 this drug to use by or on the order of a of this chapter. licensed veterinarian. (c) Conditions of use in cats—(1) Amount. The starting dose is 2.5 mg [78 FR 28824, May 20, 2014] every 12 hours. Following 3 weeks of § 520.1409 Methylprednisolone and as- treatment, the dose should be titrated pirin. to effect based on individual serum total T4 levels and clinical response. (a) Specifications. Each tablet con- (2) Indications for use. For the treat- tains 0.5 milligram of ment of hyperthyroidism. methylprednisolone and 300 milligrams (3) Limitations. Federal law restricts of aspirin. this drug to use by or on the order of a (b) Sponsor. See No. 054771 in licensed veterinarian. § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) [74 FR 27707, June 11, 2009] Amount. Under 15 pounds, 1⁄4 to 1 tablet § 520.1380 Methocarbamol. daily; 15 to 60 pounds, 1 to 2 tablets daily; 60 pounds and over, 2 tablets (a) Specifications. Each tablet con- daily. Administer total daily dose in tains 500 milligrams (mg) of divided doses 6 to 10 hours apart, with methocarbamol. a light feeding. When response is at- (b) Sponsor. See No. 054771 in tained, dosage should be gradually re- § 510.600(c) of this chapter. duced until maintenance level is (c) Conditions of use in dogs and cats— achieved. (1) Amount. Administer 60 mg per pound (2) Indications for use. As an anti-in- of body weight in two or three equally flammatory and analgesic agent. divided doses, followed each following day by 30 to 60 mg per pound of body (3) Limitations. Federal law restricts weight, usually not to exceed 14 to 21 this drug to use by or on the order of a days. licensed veterinarian. (2) Indications for use. As an adjunct [48 FR 21566, May 13, 1983, as amended at 78 to therapy for acute inflammatory and FR 28824, May 20, 2014] traumatic conditions of the skeletal muscles in order to reduce muscular § 520.1422 Metoserpate hydrochloride. spasms. (a) Chemical name. Methyl-o-methyl- (3) Limitations. Federal law restricts 18-epireserpate hydrochloride. this drug to use by or on the order of a (b) Sponsor. See No. 054771 in licensed veterinarian. § 510.600(c) of this chapter. [78 FR 28824, May 20, 2014] (c) Related tolerances. See § 556.410 of this chapter. § 520.1408 Methylprednisolone. (d) Conditions of use. It is used in (a) Specifications. Each tablet con- drinking water for replacement chick- tains 1, 2, or 4 milligrams (mg) of ens as follows: methylprednisolone. (1) Amount. 568.5 milligrams per gal- (b) Sponsors. See sponsors in lon (0.015 percent). § 510.600(c) of this chapter. (i) Indications for use. As a tranquil- (1) No. 054628 for use of 1- and 2-mg izer for flock treatment of chickens tablets. prior to handling.

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(ii) Limitations. To be used one time § 520.1441 Milbemycin oxime. as a treatment for replacement chickens up to 16 weeks of age; usual drink- (a) Specifications—(1) Dogs. Each tab- ing water should be withheld prior to let contains 2.3, 5.75, 11.5, or 23.0 milli- treatment to provide adequate con- grams of milbemycin oxime. sumption of medicated drinking water; (2) Cats. Each tablet contains 5.75, not for use in laying chickens; chick- 11.5, or 23.0 milligrams of milbemycin ens slaughtered within 72 hours fol- oxime. lowing treatment must not be used for (b) Sponsor. See 058198 in § 510.600(c) of food. this chapter. (2) Amount. 2 to 4 milligrams per 2.2 (c) [Reserved] pounds of body weight. (d) Conditions of use—(1) Dogs and (i) Indications for use. As an aid in puppies—(i) Amount. For hookworm, control of hysteria. roundworm, and whipworm, use 0.23 (ii) Limitations. To be used as a treat- milligram per pound of body weight (0.5 ment for replacement chickens up to 16 milligram per kilogram). For heart- weeks of age; usual drinking water should be withheld prior to treatment worm, use 0.05 milligram per pound of to provide adequate consumption of body weight (0.1 milligram per kilo- medicated drinking water; the drug gram). should be administered at a dosage (ii) Indications for use. For prevention level of 4 milligrams per 2.2 pounds of of heartworm disease caused by body weight followed by 2 treatments Dirofilaria immitis, control of hookworm at 4-day intervals of 2 milligrams per infections caused by Ancylostoma 2.2 pounds of body weight; not for use caninum, and removal and control of in laying chickens; chickens slaugh- adult roundworm infections caused by tered within 72 hours following treat- Toxocara canis and Toxascaris leonina ment must not be used for food. and whipworm infections caused by [40 FR 13838, Mar. 27, 1975, as amended at 76 Trichuris vulpis in dogs and in puppies 4 FR 17337, Mar. 29, 2011; 78 FR 28824, May 20, weeks of age or greater and 2 pounds of 2014] body weight or greater. (iii) Limitations. Do not use in puppies § 520.1430 Mibolerone. less than 4 weeks of age and less than (a) Specifications. Each milliliter con- 2 pounds of body weight. Administer tains 100 micrograms of mibolerone. once a month. First dose given within (b) Sponsor. See No. 054771 in 1 month after first exposure to mosqui- § 510.600(c) of this chapter. toes and continue regular use until at (c) Conditions of use in dogs—(1) least 1 month after end of mosquito Amount. 30 micrograms for animals season. Federal law restricts this drug weighing 1 to 25 pounds; 60 micrograms for animals weighing 26 to 50 pounds; to use by or on the order of a licensed 120 micrograms for animals weighing 51 veterinarian. to 100 pounds; 180 micrograms for ani- (2) Cats and kittens—(i) Amount. 0.91 mals weighing over 100 pounds, German milligram per pound of body weight (2.0 Shepherds, or German Shepherd mix. milligrams per kilogram). Administer daily, orally or in a small (ii) Indications for use. For prevention amount of food, at least 30 days before of heartworm disease caused by expected initiation of heat, and con- Dirofilaria immitis and the removal of tinue daily as long as desired, but not adult Toxocara cati (roundworm) and for more than 24 months. Ancylostoma tubaeforme (hookworm) in- (2) Indications for use. For the preven- fections in cats 6 weeks of age or great- tion of estrus (heat) in adult female er and 1.5 pounds body weight or great- dogs not intended primarily for breeder. ing purposes. (iii) Limitations. Do not use in kittens (3) Limitations. Federal law restricts less than 6 weeks of age or 1.5 pounds this drug to use by or on the order of a body weight. Administer once a month. licensed veterinarian. Federal law restricts this drug to use [43 FR 15625, Apr. 14, 1978, as amended at 78 FR 28824, May 20, 2014]

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by or on the order of a licensed veteri- § 520.1445 Milbemycin oxime and narian. praziquantel. [55 FR 25301, June 21, 1990, as amended at 55 (a) Specifications. Each chewable tab- FR 49888, Dec. 3, 1990; 58 FR 5608, Jan. 22, let contains: 1993; 60 FR 50097, Sept. 28, 1995; 61 FR 43654, (1) 2.3 milligrams (mg) milbemycin Aug. 26, 1996; 63 FR 29352, May 29, 1998; 63 FR oxime and 22.8 mg praziquantel; 41189, Aug. 3, 1998. Redesignated at 77 FR (2) 5.75 mg milbemycin oxime and 57 47512, Aug. 9, 2012] mg praziquantel; (3) 11.5 mg milbemycin oxime and 114 § 520.1443 Milbemycin oxime and lufenuron. mg praziquantel; or (4) 23 mg milbemycin oxime and 228 (a) Specifications—(1) Tablets con- mg praziquantel. taining: 2.3 milligrams (mg) (b) Sponsor. See No. 058198 in milbemycin oxime and 46 mg § 510.600(c) of this chapter. lufenuron, 5.75 mg milbemycin oxime (c) Conditions of use—(1) Dogs—(i) and 115 mg lufenuron, 11.5 mg Amount. Administer orally, once a milbemycin oxime and 230 mg month, a minimum dosage of 0.23 mg lufenuron, or 23 mg milbemycin oxime per pound (mg/lb) of body weight (0.5 and 460 mg lufenuron. mg per kilogram (mg/kg)) milbemycin (2) Flavored tablets containing: 2.3 oxime and 2.28 mg/lb of body weight (5 mg milbemycin oxime and 46 mg mg/kg) praziquantel. lufenuron, 5.75 mg milbemycin oxime (ii) Indications for use. For the pre- and 115 mg lufenuron, 11.5 mg vention of heartworm disease caused milbemycin oxime and 230 mg by Dirofilaria immitis and for the treat- lufenuron, or 23 mg milbemycin oxime ment and control of adult roundworm and 460 mg lufenuron. (Toxocara canis, Toxascaris leonina), (b) Sponsor. See No. 051311 in adult hookworm (Ancylostoma § 510.600(c) of this chapter. caninum), adult whipworm (Trichuris (c) [Reserved] vulpis), and adult tapeworm (Taenia (d) Conditions of use—(1) Dogs—(i) pisiformis, Echinococcus multilocularis, E. Amount. 0.5 mg milbemycin oxime and granulosus, and Dipylidium caninum) in- 10 mg lufenuron per kilogram of body fections in dogs and puppies 2 pounds of weight, once a month. body weight or greater and 6 weeks of (ii) Indications for use—(A) For use in age and older. dogs and puppies for the prevention of (iii) Limitations. Federal law restricts heartworm disease caused by Dirofilaria this drug to use by or on the order of a immitis, for prevention and control of licensed veterinarian. flea populations, for control of adult (2) [Reserved] Ancylostoma caninum (hookworm), and [77 FR 47512, Aug. 9, 2012, as amended at 82 for removal and control of adult FR 58556, Dec. 13, 2017] Toxocara canis, Toxascaris leonina (roundworm), and Trichuris vulpis § 520.1447 Milbemycin oxime, (whipworm) infections. lufenuron, and praziquantel tablets. (B) The concurrent use of flavored (a) Specifications. Each tablet con- milbemycin oxime and lufenuron tab- tains: lets described in paragraph (a)(2) of (1) 2.3 milligrams (mg) milbemycin this section as in paragraph (d)(1)(ii)(A) oxime, 46 mg lufenuron, and 22.8 mg of this section with nitenpyram tablets praziquantel; as in § 520.1510(d)(1) of this chapter is (2) 5.75 mg milbemycin oxime, 115 mg indicated to kill adult fleas and pre- lufenuron, and 57 mg praziquantel; vent flea eggs from hatching. (3) 11.5 mg milbemycin oxime, 230 mg (iii) Limitations. Federal law restricts lufenuron, and 114 mg praziquantel; or this drug to use by or on the order of a (4) 23 mg milbemycin oxime, 460 mg licensed veterinarian. lufenuron, and 228 mg praziquantel. (2) [Reserved] (b) Sponsor. See No. 051311 in [62 FR 28629, May 27, 1997, as amended at 63 § 510.600(c) of this chapter. FR 41190, Aug. 3, 1998; 68 FR 51905, Aug. 29, (c) [Reserved] 2003. Redesignated at 77 FR 47512, Aug. 9, (d) Conditions of use—(1) Dogs—(i) 2012, as amended at 80 FR 18776, Apr. 8, 2015] Amount. 0.5 mg milbemycin oxime, 10

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mg lufenuron, and 5 mg of praziquantel verely debilitated animals and for as- per kilogram of body weight, once a sistance in the diagnosis, treatment, month. and control of parasitism. Do not treat (ii) Indications for use. For the pre- within 14 days of slaughter. vention of heartworm disease caused by Dirofilaria immitis; for the prevention [46 FR 50949, Oct. 16, 1981. Redesignated at 49 and control of flea populations FR 47831, Dec. 7, 1984, and amended at 51 FR (Ctenocephalides felis); and for the treat- 9005, Mar. 17, 1986; 78 FR 28825, May 20, 2014] ment and control of adult roundworm § 520.1450b Morantel tartrate car- (Toxocara canis, Toxascaris leonina), tridge. adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris (a) Specifications. The drug product vulpis), and adult tapeworm (Dipylidium consists of a stainless-steel cylinder caninum, Taenia pisiformis, Echinococcus having both ends closed with poly- multilocularis, and E. granulosus) infec- ethylene diffusing discs and containing tions in dogs and puppies 2 pounds of a morantel tartrate paste. The paste body weight or greater and 6 weeks of contains 22.7 grams of morantel tar- age and older. trate equivalent to 13.5 grams of (iii) Limitations. Federal law restricts morantel base. this drug to use by or on the order of a (b) Sponsor. See No. 054771 in licensed veterinarian. § 510.600(c) of this chapter. (2) [Reserved] (c) Related tolerances. See § 556.425 of [77 FR 4225, Jan. 27, 2012, as amended at 80 this chapter. FR 18776, Apr. 8, 2015; 83 FR 13635, Mar. 30, (d) Conditions of use—(1) Amount. 2018] Grazing cattle: Administer 1 cartridge to each animal at the start of the graz- § 520.1450 Morantel tartrate oral dosage forms. ing season. (2) Indications for use. For control of § 520.1450a Morantel tartrate bolus. the adult stage of the following gastro- (a) Specifications. Each bolus contains intestinal nematode infections in 2.2 grams morantel tartrate equivalent weaned calves and yearling cattle to 1.3 grams of morantel base. weighing a minimum of 200 pounds: (b) Sponsor. See No. 054771 in Ostertagia spp., Trichostrongylus axei, § 510.600(c) of this chapter. Cooperia spp., and Oesophagostomum (c) Related tolerances. See § 556.425 of radiatum. this chapter. (3) Limitations. Administer orally (d) Conditions of use—(1) Amount. One with the dosing gun to all cattle that bolus per 500 pounds of body weight (4.4 will be grazing the same pasture. Effec- milligrams per pound of body weight) tiveness of the drug product is depend- as a single oral dose. Boluses may be ent upon continuous control of the gas- divided in half for more accurate dos- trointestinal parasites for approxi- ing as follows: up to 325 pounds, 1⁄2 mately 90 days following administra- bolus; 326 to 600 pounds, 1 bolus; 601 to tion. Therefore, treated cattle should 1 900 pounds, 1 ⁄2 boluses; and 901 to 1,200 not be moved to pastures grazed in the pounds, 2 boluses. same grazing season/calendar year by (2) Indications for use. For removal untreated cattle. Do not administer to and control of mature gastrointestinal cattle within 106 days of slaughter. nematode infections of cattle including stomach worms (Haemonchus spp., Consult your veterinarian before ad- Ostertagia spp., Trichostrongylus spp.), ministering to severely debilitated ani- worms of the small intestine (Cooperia mals and for assistance in the diag- spp., Trichostrongylus spp., Nematodirus nosis, treatment, and control of para- spp.), and worms of the large intestine sitism. (Oesophagostomum radiatum). [49 FR 47831, Dec. 7, 1984, as amended at 51 (3) Limitations. Conditions of constant FR 23415, June 27, 1986; 51 FR 41081, Nov. 13, worm exposure may require retreat- 1986; 78 FR 28825, May 20, 2014] ment in 2 to 4 weeks. Consult your veterinarian before administering to se-

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§ 520.1450c Morantel tartrate sus- development of canine heartworm dis- tained-release trilaminate cylinder/ ease. sheet. (3) Limitations. Federal law restricts (a) Specifications. The drug product this drug to use by or on the order of a consists of a trilaminated, perforated, licensed veterinarian. plastic sheet formed into a cylinder [62 FR 37713, July 15, 1997, as amended at 78 having plastic plugs in its ends. The FR 28825, May 20, 2014] core lamina contains 19.8 grams of morantel tartrate equivalent to 11.8 § 520.1452 Moxidectin gel. grams of morantel base. (b) Sponsor. See 054771 in § 510.600(c) of (a) Specifications. Each milliliter of this chapter. gel contains 20 milligrams (2 percent) (c) Related tolerances. See § 556.425 of moxidectin. this chapter. (b) Sponsor. See No. 054771 in (d) Conditions of use—(1) Amount. § 510.600(c) of this chapter. Grazing cattle: Administer 1 cartridge (c) Special considerations. See § 500.25 to each animal at the start of the graz- of this chapter. ing season. (d) Conditions of use in horses and (2) Indications for use. For control of ponies—(1) Amount. 0.4 milligram the adult stage of the following gastro- moxidectin per kilogram (2.2 pounds) of intestinal nematode infections in body weight. weaned calves and yearling cattle (2) Indications for use. For the treat- weighing a minimum of 200 pounds: ment and control of large strongyles: Ostertagia spp., Trichostrongylus axei, Strongylus vulgaris (adults and L4/L5 ar- Cooperia spp., and Oesophagostomum terial stages), S. edentatus (adult and radiatum. tissue stages), Triodontophorus (3) Limitations. Administer orally brevicauda (adults), and T. serratus with the dosing gun to all cattle that (adults); small strongyles (adults): will be grazing the same pasture. Effec- Cyathostomum spp., including C. tiveness of the drug product is depend- catinatum and C. pateratum; ent upon continuous control of the gas- Cylicocyclus. spp., including C. insigne, trointestinal parasites for approxi- C. leptostomum, C. nassatus, and C. mately 90 days following administra- radiatus; Cyliocostephanus spp., includ- tion. Therefore, treated cattle should ing C. calicatus, C. goldi, C. not be moved to pastures grazed in the longibursatus, and C. minutus; same grazing season/calendar year by Coronocyclus spp., including C. untreated cattle. Do not administer to coronatus, C. labiatus, and C. labratus; cattle within 102 days of slaughter. Gyalocephalus capitatus; and Consult your veterinarian before ad- Petrovinema poculatus; small ministering to severely debilitated ani- strongyles: undifferentiated lumenal mals and for assistance in the diag- larvae; encysted cyathostomes (late L3 nosis, treatment, and control of para- and L4 mucosal cyathostome larvae); sitism. ascarids: Parascaris equorum (adults and [56 FR 13396, Apr. 2, 1991, as amended at 78 L4 larval stages); pinworms: Oxyuris FR 28825, May 20, 2014] equi (adults and L4 larval stages); hairworms: Trichostrongylus axei § 520.1451 Moxidectin tablets. (adults); large-mouth stomach worms: (a) Specifications. Each tablet con- Habronema muscae (adults); and horse tains 30, 68, or 136 micrograms of stomach bots: Gasterophilus intestinalis moxidectin. (2nd and 3rd instars) and G. nasalis (3rd (b) Sponsor. See No. 054771 in instars). One dose also suppresses § 510.600(c) of this chapter. strongyle egg production for 84 days. (c) Conditions of use—(1) Amount. 3 (3) Limitations. Do not use in horses micrograms per kilogram (1.36 intended for human consumption. micrograms per pound) of body weight. [62 FR 42902, Aug. 11, 1997, as amended at 64 (2) Indications for use. To prevent in- FR 66105, Nov. 24, 1999; 68 FR 51445, Aug. 27, fection by the canine heartworm 2003; 69 FR 24959, May 5, 2004; 70 FR 75017, Dirofilaria immitis and the subsequent Dec. 19, 2005; 78 FR 28825, May 20, 2014]

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§ 520.1453 Moxidectin and (b) Sponsor. See No. 000859 in praziquantel gel. § 510.600(c) of this chapter. (a) Specifications. Each milliliter of (c) Related tolerances. See § 556.426 of gel contains 20 milligrams (mg) (2.0 this chapter. percent) moxidectin and 125 mg (12.5 (d) Special considerations. See § 500.25 percent) praziquantel. of this chapter. (b) Sponsor. See No. 054771 in (e) Conditions of use in sheep—(1) § 510.600(c) of this chapter. Amount. Administer 1 mL per 11 pounds (c) Special considerations. See § 500.25 body weight (1 mL per 5 kilograms) by of this chapter. mouth. (d) Conditions of use in horses and (2) Indications for use. For the treat- ponies—(1) Amount. Administer by ment and control of the adult and L4 mouth as a single dose: 0.4 mg larval stages of Haemonchus contortus, moxidectin per kilogram and 2.5 mg Teladorsagia circumcincta, T. trifurcata, praziquantel per kilogram (2.2 pounds) Trichostrongylus axei, T. colubriformis, T. body weight. vitrinus, Cooperia curticei, C. oncophora, (2) Indications for use. For the treat- Oesophagostomum columbianum, O. ment and control of large strongyles: venulosum, Nematodirus battus, N. Strongylus vulgaris (adults and L4/L5 ar- filicollis, and N. spathiger. terial stages), S. edentatus (adult and (3) Limitations. Sheep must not be tissue stages), Triodontophorus slaughtered for human consumption brevicauda (adults), and T. serratus within 7 days of treatment. Because a (adults); small strongyles (adults): withholding time in milk has not been (Cyathostomum spp., including C. established for this product, do not use catinatum and C. pateratum; Cylicocyclus in female sheep providing milk for spp., including C. insigne, C. human consumption. leptostomum, C. nassatus, and C. [70 FR 76163, Dec. 23, 2005, as amended at 76 radiatus; Cylicostephanus spp., including FR 48714, Aug. 9, 2011; 82 FR 21690, May 10, C. calicatus, C. goldi, C. longibursatus, 2017] and C. minutus; Coronocyclus spp., including C. coronatus, C. labiatus, and C. § 520.1468 Naproxen. labratus; Gyalocephalus capitatus; and (a) Specifications. Each gram of gran- Petrovinema poculatus; small ules contains 500 milligrams (mg) (50 strongyles: undifferentiated lumenal percent) naproxen. larvae; encysted cyathostomes (late L3 (b) Sponsor. See No. 054771 in and L4 mucosal cyathostome larvae); § 510.600(c) of this chapter. ascarids: Parascaris equorum (adults and L4 larval stages); pinworms: Oxyuris (c) Conditions of use in horses—(1) equi (adults and L4 larval stages); Amount. 10 mg per kilogram of body hairworms: Trichostrongylus axei weight twice daily top dressed on feed (adults); large-mouth stomach worms: for up to 14 consecutive days. Habronema muscae (adults); horse stom- (2) Indications for use. For the relief of ach bots: Gasterophilus intestinalis (2nd inflammation and associated pain and and 3rd instars) and G. nasalis (3rd lameness exhibited with arthritis, as instars); and tapeworms: Anoplocephala well as myositis and other soft tissue perfoliata (adults). One dose also sup- diseases of the musculoskeletal sys- presses strongyle egg production for 84 tem. days. (3) Limitations. Do not use in horses (3) Limitations. Do not use in horses intended for human consumption. Fed- intended for human consumption. eral law restricts this drug to use by or on the order of a licensed veterinarian. [68 FR 51446, Aug. 27, 2003, as amended at 69 FR 21956, Apr. 23, 2004; 70 FR 75017, Dec. 19, [78 FR 28825, May 20, 2014] 2005; 78 FR 28825, May 20, 2014] § 520.1484 Neomycin. § 520.1454 Moxidectin solution. (a) Specifications—(1) Each ounce of (a) Specifications. Each milliliter powder contains 20.3 grams (g) neomy- (mL) of solution contains 1 milligram cin sulfate (equivalent to 14.2 g neomy- (mg) moxidectin. cin base).

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(2) Each milliliter of solution con- § 520.1510 Nitenpyram. tains 200 milligrams (mg) neomycin (a) Specifications. Each tablet con- sulfate (equivalent to 140 mg neomycin base). tains 11.4 or 57 milligrams (mg) (b) Sponsors. See sponsors in nitenpyram. § 510.600(c) of this chapter for use as in (b) Sponsors. See sponsor numbers in paragraph (e) of this section. § 510.600(c) of this chapter: (1) Nos. 054771 and 054925 for use of (1) No. 058198 for use as in paragraphs product described in paragraph (a)(1) as (d)(1)(i)(A), (d)(1)(ii)(A), and (d)(2) of in paragraph (e)(1) of this section. this section. (2) Nos. 016592, 054771, 058005, and (2) No. 051311 for use as in paragraphs 061623 for use of product described in (d)(1)(i)(B) and (d)(1)(ii)(B) of this sec- paragraph (a)(1) as in paragraphs (e)(1) tion. and (e)(2) of this section. (c) Special considerations. The concur- (3) Nos. 016592, 054771, 054925, and rent use of nitenpyram tablets and fla- 058005 for use of product described in vored milbemycin/lufenuron tablets as paragraph (a)(2) as in paragraph (e)(1) in paragraph (d)(1)(ii)(B) of this section of this section. shall be by or on the order of a licensed (c) Related tolerances. See § 556.430 of veterinarian. this chapter. (d) Special labeling considerations. La- (d) Conditions of use—(1) Dogs—(i) beling shall bear the following warning Amount—(A) One 11.4-mg tablet for statements: ‘‘A withdrawal period has dogs weighing less than 25 pounds (lb) not been established for use in or one 57-mg tablet for dogs weighing preruminating calves. Do not use in more than 25 lb, as needed, for use as in calves to be processed for veal. Use of paragraph (d)(1)(ii)(A) of this section. more than one product containing neo- (B) One 11.4-mg tablet for dogs weigh- mycin or failure to follow withdrawal ing less than 25 lb or one 57 mg tablet times may result in illegal drug resi- for dogs weighing more than 25 lbs, dues.’’ once or twice weekly, for use as in (e) Conditions of use—(1) Cattle, swine, paragraph (d)(1)(ii)(B) of this section. sheep, and goats—(i) Amount. 10 mg per (ii) Indications for use—(A) For the pound (/lb) of body weight per day (22 treatment of flea infestations on dogs mg per kilogram (/kg)) in divided doses and puppies 4 weeks of age and older for a maximum of 14 days. and 2 lbs of body weight or greater. (ii) Indications for use. For the treat- (B) The concurrent use of nitenpyram ment and control of colibacillosis (bac- tablets as in paragraph (d)(1)(i)(B) of terial enteritis) caused by Escherichia this section with either flavored coli susceptible to neomycin sulfate. lufenuron tablets as in § 520.1288(c)(1) of (iii) Limitations. Discontinue treatment prior to slaughter as follows: Cat- this chapter or flavored milbemycin tle, 1 day; sheep, 2 days; swine and and lufenuron tablets as in goats, 3 days. Federal law restricts this § 520.1443(d)(1) is indicated to kill adult drug to use by or on the order of a li- fleas and prevent flea eggs from hatch- censed veterinarian. ing. (2) Turkeys—(i) Amount. 10 mg/lb of (2) Cats—(i) Amount—(A) One 11.4-mg body weight per day (22 mg/kg) for 5 tablet, as needed, for use as in para- days. graph (d)(2)(ii)(A) of this section. (ii) Indications for use. For the control (B) One 11.4-mg tablet, once or twice of mortality associated with E. coli sus- weekly, for use as in paragraph ceptible to neomycin sulfate in grow- (d)(2)(ii)(B) of this section. ing turkeys. (ii) Indications for use—(A) For the (iii) Limitations. Federal law restricts treatment of flea infestations on cats this drug to use by or on the order of a and kittens 4 weeks of age and older licensed veterinarian. and 2 lbs of body weight or greater. [71 FR 56866, Sept. 28, 2006, as amended at 71 (B) The concurrent use of nitenpyram FR 68738, Nov. 28, 2006; 78 FR 17596, Mar. 22, tablets as in paragraph (d)(2)(i)(B) of 2013; 78 FR 28825, May 20, 2014; 81 FR 22523, this section with flavored lufenuron Apr. 18, 2016; 81 FR 94989, Dec. 27, 2016]

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tablets as in § 520.1288(c)(2) of this chap- (ii) For prevention of gastric ulcers ter is indicated to kill adult fleas and in horses. prevent flea eggs from hatching. (3) Limitations. Do not use in horses intended for human consumption. [68 FR 51906, Aug. 29, 2003, as amended at 80 FR 18776, Apr. 8, 2015] [69 FR 13220, Mar. 22, 2004, as amended at 71 FR 59374, Oct. 10, 2006] § 520.1604 Oclacitinib. § 520.1616 Orbifloxacin tablets. (a) Specifications. Each tablet contains 3.6, 5.4, or 16 milligrams (mg) of (a) Specifications. Each tablet con- oclacitinib as oclacitinib maleate. tains 5.7, 22.7, or 68 milligrams (mg) (b) Sponsor. See No. 054771 in orbifloxacin. § 510.600(c) of this chapter. (b) Sponsor. See No. 000061 in (c) Conditions of use—(1) Amount. Ad- § 510.600(c) of this chapter. minister orally 0.18 to 0.27 mg/per (c) Conditions of use in dogs and cats— pound of body weight (0.4 to 0.6 mg/kg (1) Amount. 2.5 to 7.5 mg per kilogram body weight) twice daily for up to 14 body weight once daily. days; then administered once daily for (2) Indications for use. For manage- maintenance therapy. ment of diseases associated with bac- (2) Indications for use. For control of teria susceptible to orbifloxacin. pruritus associated with allergic der- (3) Limitations. Federal law restricts matitis and control of atopic derma- this drug to use by or on the order of a titis in dogs at least 12 months of age. licensed veterinarian. Federal law pro- (3) Limitations. Federal law restricts hibits the extralabel use of this drug in this drug to use by or on the order of a food producing animals. licensed veterinarian. [71 FR 14643, Mar. 23, 2006, as amended at 75 FR 26646, May 12, 2010] [78 FR 42007, July 15, 2013] § 520.1618 Orbifloxacin suspension. § 520.1615 Omeprazole. (a) Specifications. Each milliliter of (a) Specifications. Each gram of paste suspension contains 30 milligrams (mg) contains 0.37 gram omeprazole. orbifloxacin. (b) Sponsor. See No. 050604 in (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. 510.600(c) of this chapter. (c) Special considerations. When la- (c) Special considerations. Federal law beled for use as in paragraph (d)(2)(i) of restricts this drug to use by or on the this section, product labeling shall order of a licensed veterinarian. Fed- bear: ‘‘Federal law restricts this drug eral law prohibits the extralabel use of to use by or on the order of a licensed this drug in food-producing animals. veterinarian.’’ (d) Conditions of use—(1) Dogs—(i) (d) Conditions of use in horses—(1) Amount. 1.1 to 3.4 mg/lb (2.5 to 7.5 mg/ Amount—(i) For treatment of gastric kg) of body weight once daily. ulcers, 1.8 milligrams per pound (mg/lb) (ii) Indications for use. For the treat- of body weight (4 milligrams per kilo- ment of urinary tract infections (cys- gram (mg/kg)) once daily for 4 weeks. titis) in dogs caused by susceptible For prevention of recurrence of gastric strains of Staphylococcus ulcers, 0.9 mg/lb of body weight (2 mg/ pseudintermedius, Proteus mirabilis, Esch- kg) once daily for at least an addi- erichia coli, and Enterococcus faecalis tional 4 weeks. and skin and soft tissue infections (ii) For prevention of gastric ulcers (wounds and abscesses) in dogs caused using the premarked syringe, one dose by susceptible strains of Staphylococcus per day for 8 or 28 days. Each dose de- pseudintermedius, Staphylococcus aureus, livers at least 1 mg/kg of body weight. coagulase-positive staphylococci, Horses over 1,200 lb body weight should Pasteurella multocida, Proteus mirabilis, receive two doses per day. Pseudomonas spp., Klebsiella (2) Indications for use. (i) For treat- pneumoniae, E. coli, Enterobacter spp., ment and prevention of recurrence of Citrobacter spp., E. faecalis, b-hemolytic gastric ulcers in horses and foals 4 streptococci (Group G), and Strepto- weeks of age and older. coccus equisimilis.

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(2) Cats—(i) Amount. 3.4 mg/lb (7.5 mg/ § 520.1629 Oxfendazole paste. kg) of body weight once daily. (a)(1) Specifications. Each gram of (ii) Indications for use. For the treat- paste contains 0.375 gram oxfendazole ment of skin infections (wounds and (37.5 percent). abscesses) in cats caused by susceptible (2) Sponsor. See No. 054771 in strains of S. aureus, E. coli, and P. § 510.600(c) of this chapter. multocida. (3) Conditions of use—(i) Amount. 10 [75 FR 26646, May 12, 2010] milligrams per kilogram (2.2 pounds) of body weight. § 520.1628 Oxfendazole powder and (ii) Indications for use. The drug is pellets. used in horses for removal of the fol- (a) Specifications—(1) Powder for sus- lowing gastrointestinal worms: Large pension. Each gram of powder contains roundworms (Parascaris equorum), ma- 7.57 percent oxfendazole. ture and 4th stage larvae pinworms (Oxyuris equi), large strongyles (2) Pellets. Each gram of pellets con- (Strongylus edentatus, S. vulgaris, and S. tains 6.49 percent oxfendazole. equinus), and small strongyles. (b) Sponsor. See No. 054771 in (iii) Limitations. Horses maintained § 510.600(c) of this chapter. on premises where reinfection is likely (c) Conditions of use—(1) Amount. 10 to occur should be retreated in 6 to 8 milligrams per kilogram of body weeks. Withholding feed or water prior weight. to use is unnecessary. Administer drug (2) Indications for use. The drug is with caution to sick or debilitated used in horses for removal of the fol- horses. Not for use in horses intended lowing gastrointestinal worms: Large for food. Consult your veterinarian for roundworms (Parascaris equorum), ma- assistance in the diagnosis, treatment, ture and immature pinworms (Oxyuris and control of parasitism. equi), large strongyles (Strongylus (b)(1) Specifications. Each gram of edentatus, Strongylus vulgaris, and paste contains 185 milligrams of Strongylus equinus), and small oxfendazole (18.5 percent). strongyles. (2) Sponsor. See No. 054771 in (3) Limitations—(i) Powder for suspen- § 510.600(c) of this chapter. sion. For gravity administration via (3) Related tolerances. See § 556.495 of stomach tube or for positive adminis- this chapter. tration via stomach tube and dose sy- (4) Conditions of use—(i) Amount. 4.5 ringe. Discard unused portions of sus- milligrams per kilogram of body pension after 24 hours. Mix drug ac- weight (2.05 milligrams per pound). cording to directions prior to use. Ad- (ii) Indications for use. The drug is minister drug with caution to sick or used in cattle for the removal and con- debilitated horses. Not for use in trol of the following worms: lungworms horses intended for food. Federal law (Dictyocaulus viviparus—adult, L4); restricts this drug to use by or on the stomach worms: barberpole worms order of a licensed veterinarian. (Haemonchus contortus and H. placei— adult), small stomach worms (ii) Pellets. The drug is given by sprin- (Trichostrongylus axei—adult), brown kling on the grain portion of the ra- stomach worms (Ostertagia ostertagi— tion. Withholding feed or water prior adult, L4, inhibited L4); intestinal to administration is not necessary. Ad- worms; nodular worms minister drug with caution to sick or (Oesophagostomum radiatum—adult), debilitated horses. Not for use in hookworms (Bunostomum horses intended for food. Consult your phlebotomum—adult), small intestinal veterinarian for assistance in the diag- worms (Cooperia punctata, C. oncophora, nosis, treatment, and control of para- and C. mcmasteri—adult, L4); and tape- sitism. worms (Moniezia benedeni—adult). [44 FR 35211, June 19, 1979, as amended at 46 (iii) Limitations. For use in cattle FR 26301, May 12, 1981; 46 FR 60570, Dec. 11, only. Treatment may be repeated in 4 1981; 49 FR 28549, July 13, 1984; 61 FR 5506, to 6 weeks. Cattle must not be slaugh- Feb. 13, 1996; 78 FR 28825, May 20, 2014] tered until 11 days after treatment. Do

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not use in female dairy cattle of breed- hookworms (Bunostomum ing age. Consult a veterinarian for as- phlebotomum—adult), small intestinal sistance in the diagnosis, treatment, worms (Cooperia punctata, C. oncophora, and control of parasitism. and C. surnabada—adult, L4), and tape- [49 FR 38250, Sept. 28, 1984, as amended at 58 worms (Moniezia benedeni—adult). FR 39443, July 23, 1993; 61 FR 5506, Feb. 13, (iii) Limitations. Cattle must not be 1996; 78 FR 28825, May 20, 2014] slaughtered until 7 days after treatment. Because a withdrawal time in § 520.1630 Oxfendazole suspension. milk has not been established, do not (a) Specifications. Each milliliter of use in female dairy cattle of breeding suspension contains: age. (1) 90.6 milligrams (mg) oxfendazole (9.06 percent). [55 FR 46943, Nov. 8, 1990, as amended at 56 (2) 225.0 mg oxfendazole (22.5 percent). FR 8710, Mar. 1, 1991; 61 FR 5506, Feb. 13, 1996; (b) Sponsor. See Nos. 000010 and 054771 72 FR 10596, Mar. 9, 2007; 73 FR 45610, Aug. 6, in § 510.600(c) of this chapter. 2008; 75 FR 10166, Mar. 5, 2010; 78 FR 28825, (c) Related tolerances. See § 556.495 of May 20, 2014] this chapter. § 520.1631 Oxfendazole and trichlorfon (d) Special considerations. See § 500.25 paste. of this chapter. If labeled for administration by stomach tube: Federal law (a) Specifications. Each gram of paste restricts this drug to use by or on the contains 28.5 milligrams oxfendazole order of a licensed veterinarian. and 454.5 milligrams trichlorfon. (e) Conditions of use—(1) Horses. Use (b) Sponsor. See 054771 in § 510.600(c) of the product described in paragraph this chapter. (a)(1) of this section as follows: (c) Conditions of use—(1) Amount. 2.5 (i) Amount. 10 mg per kilogram (/kg) milligrams of oxfendazole and 40 milli- of body weight by stomach tube or dose grams of trichlorfon per kilogram of syringe. Horses maintained on prem- body weight. ises where reinfection is likely to occur (2) Indications for use. The drug is should be retreated in 6 to 8 weeks. used in horses for removal of bots (ii) Indications for use. For removal of (Gasterophilus intestinalis, 2nd and 3rd large roundworms (Parascaris equorum), instars; 3rd instar) and the mature and 4th stage larvae pinworms G. nasalis, (Oxyuris equi), large strongyles following gastrointestinal worms: (Strongylus edentatus, S. vulgaris, and S. Large roundworms (Parascaris equinus), and small strongyles. equorum), pinworms (Oxyuris equi), (iii) Limitations. Withholding feed or adult and 4th stage larvae; large water prior to use is unnecessary. Ad- strongyles (Strongylus edentatus, S. minister drug with caution to sick or vulgaris, and S. equinus); and small debilitated horses. Do not use in horses strongyles. intended for human consumption. (3) Limitations. Horses maintained on (2) Cattle. Use the products described premises where reinfection is likely to in paragraphs (a)(1) and (a)(2) of this occur should be retreated in 6 to 8 section as follows: weeks. Withholding feed or water be- (i) Amount. 4.5 mg/kg of body weight fore use is unnecessary. Administer by dose syringe. Treatment may be re- with caution to sick or debilitated peated in 4 to 6 weeks. horses. Not for use in horses intended (ii) Indications for use. For the re- for food. Do not administer to mares moval and control of: lungworms during the last month of pregnancy. (Dictyocaulus viviparus—adult, L4); Trichlorfon is a cholinesterase inhib- stomach worms: barberpole worms itor. Do not use this product in ani- (Haemonchus contortus and H. placei— mals simultaneously with, or within a adult), small stomach worms (Trichostrongylus axei—adult), brown few days before or after treatment with stomach worms (Ostertagia ostertagi— or exposure to, cholinesterase-inhib- adult, L4, inhibited L4); intestinal iting drugs, pesticides, or chemicals. worms; nodular worms (Oesophagostomum radiatum—adult),

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Consult your veterinarian for assist- (2) Carbomycin: The antibiotic sub- ance in the diagnosis, treatment, and stance produced by growth of control of parasitism. Streptomyces halstedii or the same anti- [50 FR 50291, Dec. 10, 1985, as amended at 61 biotic substance produced by any other FR 5506, Feb. 13, 1996; 78 FR 28825, May 20, means. 2014] (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 520.1638 Oxibendazole. (c) Special considerations. The quan- (a) Specifications—(1) Each gram of tities of oxytetracycline in paragraph paste contains 227 milligrams (mg) (22.7 (e) of this section refer to the activity percent) oxibendazole. of oxytetracycline hydrochloride and (2) Each milliliter of suspension con- the quantities of carbomycin listed tains 100 mg (10 percent) oxibendazole. refer to the activity of an appropriate (b) Sponsor. See No. 054771 in standard. § 510.600(c) of this chapter. (d) Related tolerances. See §§ 556.110 (c) Special considerations—(1) See and 556.500 of this chapter. § 500.25 of this chapter. (e) Conditions of use. It is used as oxy- (2) Suspension product described in paragraph (a)(2) of this section shall be tetracycline hydrochloride plus labeled: ‘‘Federal law restricts this carbomycin base in drinking water of drug to use by or on the order of a li- chickens as follows: censed veterinarian.’’ (1) Amount. Administer 1.0 gram of (d) Conditions of use in horses—(1) oxytetracycline and 1.0 gram Amount. For uses other than for carbomycin per gallon for not more threadworms (Strongyloides westeri), 10 than 5 days. mg oxibendazole per kilogram (/kg) (2) Indications for use. As an aid in the body weight; for threadworms prevention and treatment of com- (Strongyloides westeri), 15 mg/kg. Horses plicated chronic respiratory disease maintained on premises where reinfec- (air-sac infection) caused by Myco- tion is likely to occur should be re- plasma gallisepticum and secondary bac- treated in 6 to 8 weeks. Administer sus- terial organisms associated with chron- pension product by stomach tube in 3 ic respiratory disease such as E. coli. to 4 pints of warm water, or by top (3) Limitations. Not for use in chick- dressing or mixing into a portion of the ens producing eggs for human con- normal grain ration. sumption. Withdraw 24 hours before (2) Indications for use. For removal slaughter. Federal law restricts this and control of large strongyles drug to use by or on the order of a li- (Strongylus edentatus, S. equinus, S. censed veterinarian. vulgaris); small strongyles (genera Cylicostephanus, Cylicocyclus, [40 FR 13838, Mar. 27, 1975, as amended at 78 Cyathostomum, Triodontophorus, FR 28825, May 20, 2014; 81 FR 94989, Dec. 27, Cylicodontophorus, and Gyalocephalus); 2016] large roundworms (Parascaris equorum); § 520.1660b Oxytetracycline hydro- pinworms (Oxyuris equi) including var- chloride capsules. ious larval stages; and threadworms (Strongyloides westeri). (a) Specifications. The drug is in cap- (3) Limitations. Do not use in horses sule form with each capsule containing intended for human consumption. 125 or 250 milligrams of oxytetracycline hydrochloride. Oxytetracycline is the [78 FR 28825, May 20, 2014] antibiotic substance produced by § 520.1660 Oxytetracycline. growth of Streptomyces rimosus or the same antibiotic substance produced by § 520.1660a Oxytetracycline and any other means. carbomycin. (b) Sponsor. See No. 054771 in (a) Specifications. (1) Oxytetracycline: § 510.600(c) of this chapter. The antibiotic substance produced by (c) Conditions of use. (1) It is used in growth of Streptomyces rimosus or the dogs and cats for the treatment of bac- same antibiotic substance produced by terial pneumonia caused by Brucella any other means. bronchiseptica, tonsilitis caused by

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Streptococcus hemolyticus, bacterial en- (2)(i) Amount. 500 milligrams per 100 teritis caused by Escherichia coli, uri- pound of body weight every 12 hours (10 nary tract infections caused by Esch- milligrams per pound of body weight erichia coli, and wound infections daily in two doses). caused by Staphylococcus aureus. (ii) Indications for use. For treatment (2) The drug is administered orally to of bacterial enteritis caused by Sal- dogs and cats at a dosage level of 25–50 monella typhimurium and Escherichia coli milligrams per pound of body weight (colibacillosis) and bacterial pneu- per day in divided doses at 12-hour in- monia (shipping fever complex, tervals. The drug can be used for con- pasteurellosis) caused by Pasteurella tinuation of compatible antibiotic multocida. therapy following parenteral oxytetra- (3) Limitations. Dosage should con- cycline administration where rapidly tinue until the animal returns to nor- attained, sustained antibiotic blood mal and for 24 hours to 48 hours after levels are required. The duration of symptoms have subsided. Treatment treatment required to obtain favorable should not exceed 4 consecutive days. response will depend to some extent on Do not exceed 500 milligrams per 100 the severity and degree of involvement pounds of body weight every 12 hours and the susceptibility of the infectious (10 milligrams per pound daily). For agent. Clinical response to antibiotic sponsor No. 054771: Discontinue treat- therapy usually occurs within 48 to 72 ment 7 days prior to slaughter. Not for hours. If improvement is not observed use in lactating dairy cattle. A with- within that period, the diagnosis and drawal period has not been established course of treatment should be reconsid- ered. To assure adequate treatment, for this product in preruminating administration of the drug should con- calves. Do not use in calves to be proc- tinue for at least 48 hours following fa- essed for veal. vorable clinical response. [46 FR 32440, June 23, 1981, as amended at 50 (3) Federal law restricts this drug to FR 1045, Jan. 9, 1985; 63 FR 70334, Dec. 21, use by or on the order of a licensed vet- 1998; 70 FR 16394, Apr. 4, 2005; 78 FR 28825, erinarian. May 20, 2014] [40 FR 13838, Mar. 27, 1975, as amended at 78 § 520.1660d Oxytetracycline powder. FR 28825, May 20, 2014] (a) Specifications. The drug is a solu- § 520.1660c Oxytetracycline hydro- ble powder distributed in packets or chloride tablets/boluses. pails having several concentrations of (a) Specifications. Each tablet or bolus oxytetracycline hydrochloride (inde- contains 250, 500, or 1,000 milligrams of pendent of the various net weights) as oxytetracycline hydrochloride. follows: (b) Sponsors. For sponsors in (1) Each 18.14 grams of powder con- § 510.600(c) of this chapter: See 000010 tains 1 gram of oxytetracycline hydro- for use of 500 and 1,000 milligram chloride (OTC HCl) (packets: 4, 6.4, and boluses. See No. 054771 for use of 250 16 oz.). and 500 milligram tablets. (2) Each 4.43 grams of powder con- (c) Tolerances. See § 556.500 of this tains 1 gram of OTC HCl (packets: 4 chapter. and 16 oz.). (d) Conditions of use in beef and dairy (3) Each 1.32 grams of powder con- cattle—(1)(i) Amount. 250 milligrams per tains 1 gram of OTC HCl (packets: 2.39, 100 pounds of body weight every 12 4.78, and 9.55 oz.; jars: 2.25 lbs.; and hours (5 milligrams per pound of body pails: 4.5 lbs.). weight daily in two doses). (4) Each 2.73 grams of powder con- (ii) Indications for use. For control of tains 1 gram of OTC HCl (packets: 2.46 bacterial enteritis caused by Salmonella and 9.87 oz, 3.09 and 3.91 lb; pail: 3.09 lb). typhimurium and Escherichia coli (5) Each 4.2 grams of powder contains (colibacillosis) and bacterial pneu- 1 gram of OTC HCl (packets: 3.8 and monia (shipping fever complex, 15.2 oz; pails: 4.74 and 23.7 lb). pasteurellosis) caused by Pasteurella (6) Each 1.32 grams of powder con- multocida. tains 1 gram of OTC HCl (packet: 4.78

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oz.; pail: 5 lb). Each 2.73 grams of pow- (2) Indications for use. Control of in- der contains 1 gram of OTC HCl (pack- fectious synovitis caused by Myco- et: 9.87 oz). plasma synoviae susceptible to oxytet- (7) Each 1.32 grams of powder con- racycline. tains 1 gram of OTC HCl (packet: 4.78 (3) Do not use in birds producing eggs and 9.6 oz.; pails: 2 and 5 lb); each 18.1 for human consumption. Federal law grams of powder contains 1 gram of restricts this drug to use by or on the OTC HCl (packet: 6.4 oz.; pails: 2 and 5 order of a licensed veterinarian. lb). (B)(1) Amount. Administer 400 to 800 (8) Each 135.5-gram packet (4.78 milligrams/gallon for 7 to 14 days. Not ounce) contains 102.4 grams of OTC to be used for more than 14 consecutive HCl. Each 677.5-gram packet (23.9 days. ounce) contains 512 grams of OTC HCl. (2) Indications for use. Control of (9) Each 2.73 grams of powder con- chronic respiratory disease (CRD) and tains 1 gram of OTC HCl (packets: 9.87 air sac infections caused by Myco- and, 19.75 oz, and 3.91 lb; pails: 3.09 and plasma gallisepticum and E. coli suscep- 5 lb). tible to oxytetracycline; control of (10) Each 2.73 grams of powder con- fowl cholera caused by Pasteurella tains 1 gram of OTC HCl (packets: 9.87 multocida susceptible to oxytetra- and 19.74 oz; pails: 5 lb). cycline. (b) Sponsor. See sponsor numbers in (3) Do not use in birds producing eggs § 510.600(c) of this chapter as follows: for human consumption. Federal law (1) No. 054771 for use of OTC HCl con- restricts this drug to use by or on the centrations in paragraphs (a)(1), (a)(2), order of a licensed veterinarian. and (a)(3) of this section in chickens, (ii) Turkeys—(A)(1) Amount. Admin- turkeys, swine, cattle, sheep, and ister 200 to 400 milligrams/gallon for 7 honey bees. to 14 days. Not to be used for more (2) No. 016592 for use of OTC HCl con- than 14 consecutive days. centration in paragraph (a)(4) of this (2) Indications for use. Control of section in chickens, turkeys, and hexamitiasis caused by Hexamita swine. meleagridis susceptible to oxytetra- (3) No. 066104 for use of OTC HCl con- cycline. centration in paragraph (a)(5) of this (3) Do not use in birds producing eggs section in turkeys and chickens. for human consumption. Withdraw 5 (4) No. 057561 for use of OTC HCl con- days prior to slaughter those products centration in paragraph (a)(6) of this sponsored by Nos. 054771 and 061623 in section in chickens, turkeys, and § 510.600(c) of this chapter. Withdraw 4 swine. days prior to slaughter those products (5) No. 061623 for use of OTC HCl con- sponsored by No. 054628. Zero-day with- centration in paragraph (a)(7) of this drawal for those products sponsored by section in chickens, turkeys, swine, Nos. 057561 and 069254. Federal law re- cattle, sheep, and honeybees. stricts this drug to use by or on the (6) No. 069254 for use of OTC HCl con- order of a licensed veterinarian. centrations in paragraph (a)(8) of this (B)(1) Amount. Administer 400 milli- section in chickens, turkeys, swine, grams/gallon for 7 to 14 days. Not to be cattle, sheep, and honey bees. used for more than 14 consecutive days. (7) No. 061623 for use of OTC HCl con- (2) Indications for use. Control of in- centration in paragraph (a)(9) of this fectious synovitis caused by Myco- section in chickens, turkeys, and plasma synoviae susceptible to oxytet- swine. racycline. (c) Related tolerances. See § 556.500 of (3) Do not use in birds producing eggs this chapter. for human consumption. Withdraw 5 (d) Conditions of use. (1) It is used in days prior to slaughter those products drinking water as follows: sponsored by Nos. 054771 and 061623 in (i) Chickens—(A)(1) Amount. Admin- § 510.600(c) of this chapter. Withdraw 4 ister 200 to 400 milligrams/gallon for 7 days prior to slaughter those products to 14 days. Not to be used for more sponsored by No. 054628. Zero-day with- than 14 consecutive days. drawal for those products sponsored by

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Nos. 057561 and 069254. Federal law re- (C) Withdraw 5 days prior to slaugh- stricts this drug to use by or on the ter. A milk discard period has not been order of a licensed veterinarian. established for this product in lac- (C)(1) Amount. Administer 25 milli- tating dairy cattle. Do not use in fe- grams per pound of body weight daily male dairy cattle 20 months of age or for 7 to 14 days. Not to be used for more older. Federal law restricts this drug to than 14 consecutive days. use by or on the order of a licensed vet- (2) Indications for use. Growing tur- erinarian. keys. Control of complicating bacterial (v) Sheep—(A) Amount. Administer 10 organisms associated with bluecomb milligrams per pound of body weight (transmissible enteritis, coronaviral daily for up to 14 days. Not to be used enteritis) susceptible to oxytetra- for more than 14 consecutive days. cycline. (B) Indications for use. Control and (3) Do not use in birds producing eggs treatment of bacterial enteritis caused for human consumption. Withdraw 5 by E. coli and bacterial pneumonia days prior to slaughter those products (shipping fever complex) caused by P. sponsored by Nos. 054771 and 061623 in multocida susceptible to oxytetra- § 510.600(c) of this chapter. Withdraw 4 cycline. days prior to slaughter those products (C) Withdraw 5 days prior to slaugh- sponsored by No. 054628. Zero-day with- ter. Federal law restricts this drug to use by or on the order of a licensed vet- drawal for those products sponsored by erinarian. Nos. 057561 and 069254. Federal law re- (2) It is used in the food of honey bees stricts this drug to use by or on the as follows: order of a licensed veterinarian. (i) Amount. 200 milligrams per colony, (iii) Swine—(A) Amount. Administer administered via either a 1:1 sugar 10 milligrams per pound of body weight syrup (equal parts of sugar and water daily for up to 14 days. Do not use for weight to weight) or dusting with a more than 14 consecutive days. powdered sugar mixture. The drug is (B) Indications for use. Control and administered in 3 applications of sugar treatment of bacterial enteritis caused syrup or 3 dustings at 4- to 5-day inter- by Escherichia coli and Salmonella vals. choleraesuis and bacterial pneumonia (ii) Indications for use. For control of caused by Pasteurella multocida suscep- American foulbrood caused by tible to oxytetracycline. For breeding Paenibacillus larvae and European swine: Control and treatment of lepto- foulbrood caused by Streptococcus spirosis (reducing the incidence of pluton susceptible to oxytetracycline. abortions and shedding of leptospira) (iii) The drug should be fed early in caused by Leptospira pomona suscep- the spring or fall and consumed by the tible to oxytetracycline. bees before main honey flow begins to (C) Withdraw zero days prior to avoid contamination of production slaughter those products sponsored by honey. Remove at least 6 weeks prior Nos. 054771, 057561, 061623, and 069254 in to main honey flow. Federal law re- § 510.600(c) of this chapter. Withdraw 4 stricts this drug to use by or on the days prior to slaughter those products order of a licensed veterinarian. sponsored by No. 054628. Federal law restricts this drug to use by or on the [40 FR 13838, Mar. 27, 1975] order of a licensed veterinarian. EDITORIAL NOTE: For FEDERAL REGISTER ci- (iv) Calves, beef cattle, and nonlac- tations affecting § 520.1660d, see the List of tating dairy cattle—(A) Amount. Admin- CFR Sections Affected, which appears in the ister 10 milligrams per pound of body Finding Aids section of the printed volume and at www.fdsys.gov. weight daily for up to 14 days. Do not use for more than 14 consecutive days. § 520.1696 Penicillin. (B) Indications for use. Control and treatment of bacterial enteritis caused § 520.1696a [Reserved] by E. coli and bacterial pneumonia (shipping fever complex) caused by P. § 520.1696b Penicillin G powder. multocida susceptible to oxytetra- (a) Specifications. Each gram of pow- cycline. der contains penicillin G potassium

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equivalent to 1.54 million units of peni- (c) Conditions of use in dogs and cats— cillin G. (1) Amount. 10 to 15 milligrams per (b) Sponsors. See Nos. 010515, 016592, pound of body weight every 6 to 8 054771, 061623 and 076475 in § 510.600(c) of hours. this chapter. (2) Indications for use. Treatment of (c) Related tolerances. See § 556.510 of respiratory, urogenital, skin and soft this chapter. tissue infections and septicemia caused (d) Conditions of use in turkeys— (1) by pathogens susceptible to penicillin Amount. 1,500,000 units per gallon V potassium. drinking water for 5 days. (3) Limitations. Federal law restricts (2) Indications for use. Treatment of this drug to use by or on the order of a erysipelas caused by Erysipelothrix licensed veterinarian. rhusiopathiae. [57 FR 37327, Aug. 18, 1992, as amended at 59 (3) Limitations. Discontinue treat- FR 58775, Nov. 15, 1994; 78 FR 28826, May 20, ment at least 1 day prior to slaughter. 2014] Not for use in turkeys producing eggs for human consumption. Federal law § 520.1705 Pergolide. restricts this drug to use by or on the (a) Specifications. Each tablet con- order of a licensed veterinarian. tains 1 milligram (mg) peroglide (as [57 FR 37326, Aug. 18, 1992, as amended at 59 pergolide mesylate). FR 42493, Aug. 18, 1994; 60 FR 26359, May 17, (b) Sponsor. See No. 000010 in 1995; 62 FR 55160, Oct. 23, 1997; 65 FR 10705, § 510.600(c) of this chapter. Feb. 29, 2000; 66 FR 14073, Mar. 9, 2001; 68 FR (c) Conditions of use in horses—(1) 4914, Jan. 31, 2003; 68 FR 26204, May 15, 2003; Amount. Administer orally at a start- 69 FR 9946, Mar. 3, 2004; 69 FR 41428, July 9, ing dose of 2 micrograms/kilograms (μ/ 2004; 77 FR 20988, Apr. 9, 2012; 78 FR 28825, kg) once daily. Dosage may be adjusted May 20, 2014; 81 FR 22523, Apr. 18, 2016; 81 FR μ 36789, June 8, 2016; 81 FR 94990, Dec. 27, 2016] to effect, not to exceed 4 g/kg daily. (2) Indications for use. For the control § 520.1696c Penicillin V powder. of clinical signs associated with Pitui- tary Pars Intermedia Dysfunction (a) Specifications. When reconstituted, (Equine Cushing’s Disease). each milliliter contains 25 milligrams (3) Limitations. Federal law restricts (40,000 units) of penicillin V. this drug to use by or on the order of a (b) Sponsor. See No. 050604 in licensed veterinarian. § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— [77 FR 15960, Mar. 19, 2012, as amended at 81 (1) Amount. 10 to 15 milligrams per FR 22523, Apr. 18, 2016] pound of body weight every 6 to 8 hours. § 520.1720 Phenylbutazone oral dosage forms. (2) Indications for use. Treatment of respiratory, urogenital, skin, and soft § 520.1720a Phenylbutazone tablets tissue infections and septicemia caused and boluses. by pathogens susceptible to penicillin (a) Specifications. Each tablet con- V potassium. tains 100, 200, or 400 milligrams (mg), or (3) Limitations. Federal law restricts 1 gram (g) of phenylbutazone. Each this drug to use by or on the order of a bolus contains 1, 2, or 4 gram g of licensed veterinarian. phenylbutazone. [57 FR 37326, Aug. 18, 1992; 57 FR 42623, Sept. (b) Sponsors. See sponsor numbers in 15, 1992; 77 FR 20988, Apr. 9, 2012; 78 FR 28826, § 510.600(c) of this chapter, as follows: May 20, 2014] (1) No. 000061 for use of 100- or 400-mg or 1-g tablets, or 2- or 4-g boluses, in § 520.1696d Penicillin V tablets. dogs and horses. (a) Specifications. Each tablet con- (2) Nos. 054628 and 069043 for use of tains penicillin V potassium equivalent 100- or 200-mg or 1-g tablets in dogs and to 125 milligrams (200,000 units) or 250 horses. milligrams (400,000 units) of penicillin (3) Nos. 054771 and 061623 for use of V. 100-mg or 1-g tablets in dogs and (b) Sponsors. See Nos. 050604 and horses. 054771 in § 510.600(c) of this chapter. (4) [Reserved]

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(5) No. 000143 for use of 1-g tablets in § 520.1720c Phenylbutazone paste. horses. (a) Specifications—(1) Each gram of (6) No. 058829 for use of 100-mg or 1-g paste contains 0.2 grams tablets in dogs and horses. phenylbutazone. (c) Conditions of use—(1) Dogs—(i) (2) Each gram of paste contains 0.35 Amount. 20 mg per pound of body grams phenylbutazone. weight daily. (b) Sponsors. See sponsor numbers in (ii) Indications for use. For the relief § 510.600(c) of this chapter. of inflammatory conditions associated (1) No. 000061 for use of product de- with the musculoskeletal system. scribed in paragraph (a)(1) of this sec- (iii) Limitations. Federal law restricts tion. this drug to use by or on the order of a (2) No. 017030 for use of product de- licensed veterinarian. scribed in paragraph (a)(2) of this sec- (2) Horses—(i) Amount. 1 to 2 g per 500 tion. pounds of body weight daily. (c) Conditions of use in horses—(1) (ii) Indications for use. For the relief Amount. 1 to 2 grams of phenylbutazone of inflammatory conditions associated per 500 pounds of body weight, not to with the musculoskeletal system. exceed 4 grams daily. (2) Indications for use. For relief of in- (iii) Limitations. Do not use in horses flammatory conditions associated with intended for human consumption. Fed- the musculoskeletal system. eral law prohibits the use of this drug (3) Limitations. Do not use in horses in female dairy cattle 20 months of age intended for human consumption. Fed- or older. Federal law restricts this drug eral law prohibits the use of this drug to use by or on the order of a licensed in female dairy cattle 20 months of age veterinarian. or older. Federal law restricts this drug [73 FR 8192, Feb. 13, 2008, as amended at 74 to use by or on the order of a licensed FR 1146, Jan. 12, 2009; 76 FR 11331, Mar. 2, veterinarian. 2011; 76 FR 17777, Mar. 31, 2011; 78 FR 21060, Apr. 9, 2013; 78 FR 28826, May 20, 2014; 81 FR [45 FR 84762, Dec. 23, 1980, as amended at 58 17607, Mar. 30, 2016] FR 29777, May 24, 1993; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 68 FR 43926, § 520.1720b Phenylbutazone granules. July 25, 2003; 72 FR 60550, Oct. 25, 2007; 77 FR 4897, Feb. 1, 2012; 78 FR 28826, May 20, 2014; 79 (a) Specifications. Each package of FR 74020, Dec. 15, 2014] granules contains 1 or 8 grams of phenylbutazone. § 520.1720d Phenylbutazone gel. (b) Sponsors. See sponsors in (a) Specifications. Each 30 grams of gel § 510.600(c) of this chapter. contains 4 grams of phenylbutazone. (1) No. 000061 for 8-gram package. (b) Sponsor. See No. 061623 in (2) No. 059320 for 1-gram package. § 510.600(c) of this chapter. require bio- (c) Conditions of use in horses—(1) equivalency and safety information. Amount. Administer 1 to 2 grams per (c) Conditions of use in horses—(1) 500 pounds of body weight, not to ex- Amount. 1 to 2 grams of phenylbutazone ceed 4 grams, daily as required. by add- per 500 pounds of body weight, not to ing to a portion of the usual grain ra- exceed 4 grams daily. tion. (2) Indications for use. For relief of inflammatory conditions associated with (2) Indications for use. For the treat- the musculoskeletal system of horses. ment of inflammatory conditions asso- (3) Limitations. Do not use in horses ciated with the musculoskeletal sys- intended for human consumption. Fed- tem. eral law prohibits the use of this drug (3) Limitations. Do not use in horses in female dairy cattle 20 months of age intended for human consumption. Fed- or older. Federal law restricts this drug eral law prohibits the use of this drug to use by or on the order of a licensed in female dairy cattle 20 months of age veterinarian. or older. Federal law restricts this drug to use by or on the order of a licensed [50 FR 13561, Apr. 5, 1985, as amended at 50 veterinarian. FR 49372, Dec. 2, 1985; 55 FR 8462, Mar. 8, 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, [78 FR 28826, May 20, 2014] 2003; 78 FR 28826, May 20, 2014]

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§ 520.1720e Phenylbutazone powder. per kilogram) body weight, using a (a) Specifications—(1) Each 1.15 grams suitable combination of whole or half (g) of powder contains 1 g tablets. The total daily dose should be phenylbutazone. divided into two portions administered (2) Each 10 g of powder contains 1 g approximately 12 hours apart. phenylbutazone. (2) Indications for use. For the man- (b) Sponsors. See sponsor numbers in agement of the signs of mild, mod- § 510.600(c) of this chapter. erate, or severe (modified New York (1) No. 027053 for use of product de- Heart Association Class II, III, or IV) scribed in paragraph (a)(1) of this sec- congestive heart failure due to atrio- tion. ventricular valvular insufficiency or (2) No. 057699 for use of product de- dilated cardiomyopathy; for use with scribed in paragraph (a)(2) of this sec- concurrent therapy for congestive tion. heart failure as appropriate on a case- (c) Conditions of use in horses—(1) by-case basis. Amount. Administer 1 to 2 g (1 to 2 level (3) Limitations. Federal law restricts scoops, using the scoop provided) per this drug to use by or on the order of a 500 pounds of body weight on a small licensed veterinarian. amount of palatable feed, not exceed 4 [72 FR 27733, May 17, 2007, as amended at 79 g per animal daily. FR 18158, Apr. 1, 2014] (2) Indications for use. For the relief of inflammatory conditions associated § 520.1802 Piperazine-carbon disulfide with the musculosketetal system. complex oral dosage forms. (3) Limitations. Do not use in horses § 520.1802a Piperazine-carbon disul- intended for human consumption. Fed- fide complex suspension. eral law prohibits the extralabel use of this product in female cattle 20 months (a) Specifications. Each fluid ounce of of age or older. Federal law restricts suspension contains 7.5 grams of piper- this drug to use by or on the order of a azine-carbon disulfide complex. The pi- licensed veterinarian. perazine-carbon disulfide complex contains equimolar parts of piperazine and [72 FR 27956, May 18, 2007] carbon disulfide (1 gram contains 530 mgs of piperazine and 470 mgs of carbon § 520.1760 Phenylpropanolamine. disulfide). (a) Specifications. Each chewable tab- (b) Sponsor. See No. 054771 in let contains 25, 50, or 75 milligram (mg) § 510.600(c) of this chapter. phenylpropanolamine hydrochloride. (c) Conditions of use in horses and (b) Sponsors. See No. 055246 in ponies—(1) Amount. Administer 1 fluid § 510.600(c) of this chapter. ounce per 100 pounds of body weight by (c) Conditions of use in dogs—(1) stomach tube or dose syringe after Amount. Administer 2 mg/kg of body withholding feed overnight or for 8 to weight twice daily. 10 hours. (2) Indications for use. For the control (2) Indications for use. For removing of urinary incontinence due to urethral ascarids (large roundworms, Parascaris sphincter hypotonus in dogs. equorum), bots (Gastrophilus spp.), small (3) Limitations. Federal law restricts strongyles, large strongyles (Strongyles this drug to use by or on the order of a spp.), and pinworms (Oxyuris equi). licensed veterinarian. (3) Limitations. Do not use in horses [77 FR 15961, Mar. 19, 2012] intended for human consumption. Fed- eral law restricts this drug to use by or § 520.1780 Pimobendan. on the order of a licensed veterinarian. (a) Specifications. Each chewable tab- [45 FR 52781, Aug. 8, 1980, as amended at 78 let contains 1.25, 2.5, 5, or 10 milligrams FR 28826, May 20, 2014] (mg) pimobendan. (b) Sponsor. See No. 000010 in § 520.1802b Piperazine-carbon disul- § 510.600(c) of this chapter. fide complex boluses. (c) Conditions of use in dogs—(1) (a) Specifications. Each bolus contains Amount. Administer orally at a total 20 grams of piperazine-carbon disulfide daily dose of 0.23 mg per pound (0.5 mg complex.

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(b) Sponsor. See No. 054771 in (3) Limitations. Do not use in horses § 510.600(c) of this chapter. intended for human consumption. Fed- (c) Conditions of use in horses and eral law restricts this drug to use by or ponies—(1) Amount. For removal of on the order of a licensed veterinarian. ascarids and small strongyles, 1 bolus [45 FR 52782, Aug. 8, 1980, as amended at 78 (20 grams) per 500 pounds body weight; FR 28826, May 20, 2014] removal of large strongyles, pinworms, and bots, 1 bolus per 250 pounds body § 520.1803 Piperazine citrate capsules. weight. (a) Specifications. Each capsule con- (2) Indications for use. For removing tains piperazine citrate equivalent to ascarids (large roundworms, Parascaris 140 milligrams of piperazine base. equorum), large strongyles (Strongylus (b) Sponsor. See No. 021091 in spp.) bots (Gastrophilus spp.), small § 510.600(c) of this chapter. strongyles, and pinworms (Oxyuris (c) Conditions of use in dogs and cats— equi). (1) Amount. The contents of 1 capsule (3) Limitations. Withhold feed over- should be mixed with the food of the night or for 8 to 10 hours. Give water animal for each 5 pounds, or fraction just before and/or after treatment. Re- thereof of body weight, except dogs sume regular feeding 4 to 6 hours after weighing over 25 pounds should be treatment. Treatment of debilitated or given the contents of 6 capsules. The anemic animals is contraindicated. Do drug should be mixed in 1/2 of the reg- not administer to animals that are or ular feeding and when the animal has were recently affected with colic, diar- finished eating the dosed food, the re- rhea, or infected with a serious infec- mainder of the food may be given. Dogs tious disease. As with most and cats may be wormed at 6 to 8 anthelmintics, drastic cathartics or weeks of age. The first treatment other gastrointestinal irritants should should be repeated 10 days later. Rein- not be administered in conjunction fection may occur. Repeat treatment if with this drug. Animals in poor condi- indicated. tion or heavily parasitized should be (2) Indications for use. For the re- given one half the recommended dose moval of large roundworms (Toxocara and treated again in 2 or 3 weeks. Con- canis and Toxascaris leonina). sult your veterinarian for assistance in (3) Limitations. Severely debilitated the diagnosis, treatment, and control animals should not be treated except of parasitism. on the advice of a veterinarian. [45 FR 52782, Aug. 8, 1980, as amended at 78 [40 FR 13838, Mar. 27, 1975, as amended at 54 FR 38515, Sept. 19, 1989; 78 FR 28826, May 20, FR 28826, May 20, 2014] 2014]

§ 520.1802c Piperazine-carbon disul- § 520.1804 Piperazine phosphate cap- fide complex with phenothiazine sules. suspension. (a) Specifications. Each capsule con- (a) Specifications. Each fluid ounce tains 120, 300, or 600 milligrams of pi- contains 5 grams of piperazine-carbon perazine phosphate monohydrate. disulfide complex and 0.83 gram of (b) Sponsor. See No. 054771 in phenothiazine. § 510.600(c) of this chapter. (b) Sponsor. See No. 054771 in (c) Conditions of use—(1) Amount. 60 § 510.600(c) of this chapter. milligrams of piperazine phosphate (c) Conditions of use in horses and monohydrate per pound of body weight. ponies—(1) Amount. Administer 1 fluid (2) Indications for use—(i) Dogs. It is ounce per 100 pounds of body weight by used for the removal of large stomach tube or dose syringe after roundworms (ascarids) Toxocara canis withholding feed overnight or for 8 to and Toxascaris leonina. 10 hours. (ii) Cats. It is used for the removal of (2) Indications for use. For removing large roundworms (ascarids) Toxocara ascarids (large roundworms, Parascaris mystax and Toxacaris leonina. equorum), bots (Gastrophilus spp.), small (3) Limitations. Administer in ani- strongyles, and large strongyles mal’s food or milk. For animals up to (Strongylus spp.). 1 year of age administer every 2 or 3

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months; for animals over 1 year old, roundworms (Toxocara canisand administer periodically as necessary. Toxascaris leonina). Consult your veterinarian for assist- (2) Dosage. Administer 20 to 30 mg pi- ance in the diagnosis, treatment, and perazine base per pound body weight as control of parasitism. a single dose. [43 FR 6941, Feb. 17, 1978; 43 FR 9804, Mar. 10, (3) Limitations. Administer by mixing 1978, as amended at 46 FR 20158, Apr. 3, 1981; into the animal’s ration to be con- 69 FR 31878, June 8, 2004; 78 FR 28826, May 20, sumed at one feeding. For animals in 2014] heavily contaminated areas, reworm at monthly intervals. Not for use in § 520.1805 Piperazine phosphate with unweaned pups or animals less than 3 thenium closylate tablets. weeks of age. (a) Specifications. Each scored tablet [70 FR 17319, Apr. 6, 2005] contains the equivalent of 250 milligrams piperazine hexahydrate (as pi- § 520.1807 Piperazine. perazine phosphate) and 125 milligrams (a) Specifications. A soluble powder or thenium (as thenium closylate) or 500 liquid containing piperazine milligrams piperazine hexahydrate (as dihydrochloride or dipiperazine sulfate, piperazine phosphate) and 250 milli- equivalent to 17, 34, or 230 grams of pi- grams thenium (as thenium closylate). perazine per pound or 100 milliliters. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (b) Sponsor. See No. 015565 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Ad- minister orally to dogs as follows: (c) Related tolerances. See § 556.513 of this chapter. NUMBER OF TABLETS AT EACH OF THE TWO (d) Conditions of use—(1) Chickens—(i) DOSES Amount. 50 milligrams per bird under 6 weeks, 100 milligrams per bird over 6 Animal weight (lb) 375 mg 750 mg weeks. (ii) Indications for use. For removal of 2 but less than 5 ...... 1⁄2 ...... 5 but less than 10 ...... 1 1⁄2 large roundworm (Ascaridia spp.). 10 or heavier ...... 2 1 (iii) Limitations. For use in drinking water or feed. Use as sole source of (2) Indications for use. For removal of drinking water. Prepare fresh solution immature (fourth stage larvae) and daily. Use as 1-day single treatment. adult hookworms (Ancylostoma Withdraw 14 days prior to slaughter. caninum, A. braziliense, and Uncinaria Do not use for chickens producing eggs stenocephala) and ascarids (Toxocara for human consumption. Consult your canis) from weaned pups and adult veterinarian for assistance in the diag- dogs. nosis, treatment, and control of para- (3) Limitations. Federal law restricts sitism. this drug to use by or on the order of a (2) Turkeys—(i) Amount. 100 milli- licensed veterinarian. grams per bird up to 12 weeks and 200 [43 FR 32747, July 28, 1978, as amended at 47 milligrams per bird over 12 weeks. FR 55476, Dec. 10, 1982; 61 FR 8873, Mar. 6, (ii) Indications for use. For removal of 1996; 62 FR 61625, Nov. 19, 1997; 78 FR 28826, large roundworm (Ascaridia spp.). May 20, 2014] (iii) Limitations. For use in drinking water or feed. Use as sole source of § 520.1806 Piperazine suspension. drinking water. Prepare fresh solution (a) Specifications. Each milliliter of daily. Use as 1-day single treatment. suspension contains piperazine Withdraw 14 days prior to slaughter. monohydrochloride equivalent to 33.5 Consult your veterinarian for assist- milligrams (mg) piperazine base. ance in the diagnosis, treatment, and (b) Sponsor. See No. 017135 in control of parasitism. § 510.600(c) of this chapter. (3) Swine—(i) Amount. 50 milligrams (c) Special considerations. See per pound of body weight. § 500.25(c) of this chapter. (ii) Indications for use. For removal of (d) Conditions of use in dogs—(1) Indi- large roundworm (Ascaris suum) and cations for use. For the removal of nodular worms (Oesophagostomum spp.).

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(iii) Limitations. For use in drinking poloxalene) per 100 pounds of body water or feed. Use as sole source of weight per day. Provide access to drinking water. Prepare fresh solution blocks at least 7 days before exposure daily. Use as 1-day single treatment. to bloat-producing conditions. Withdraw 21 days prior to slaughter. [40 FR 13838, Mar. 27, 1975, as amended at 40 Consult your veterinarian for assist- FR 39857, Aug. 29, 1975; 42 FR 41854, Aug. 19, ance in the diagnosis, treatment, and 1977; 50 FR 5385, Feb. 8, 1985; 54 FR 33501, Aug. control of parasitism. 15, 1989; 56 FR 50653, Oct. 8, 1991; 58 FR 26523, [64 FR 23018, Apr. 29, 1999, as amended at 79 May 4, 1993; 60 FR 55659, Nov. 2, 1995; 66 FR FR 28827, May 20, 2014] 47963, Sept. 17, 2001; 69 FR 62811, Oct. 28, 2004; 70 FR 32489, June 3, 2005; 78 FR 28826, May 20, § 520.1840 Poloxalene. 2014] (a) Specifications. Polyoxypropylene- § 520.1846 Polyoxyethylene (23) lauryl polyoxyethylene glycol nonionic block ether blocks. polymer. (a) Specifications. Each molasses- (b) Sponsors. See sponsors in based block contains 2.2 percent § 510.600(c) of this chapter for use as in polyoxyethylene (23) lauryl ether. paragraph (d) of this section. (b) Sponsor. See No. 067949 in (1) No. 054771 for use as in paragraphs § 510.600(c) of this chapter. (d)(1) and (d)(3) of this section. (c) Conditions of use—(1) Amount. 2 (2) No. 051311 for use as in paragraph grams of polyoxyethylene (23) lauryl (d)(4) of this section. ether per 100 kilograms of body weight (3) No. 067949 for use as in paragraph per day (1 pound of block per 500 kilo- (d)(2) of this section. (4) No. 066104 for use as in paragraph gram (1,100 pound) animal per day). (d)(3) of this section. (2) Indications for use. For reduction (c) [Reserved] of the incidence of bloat (alfalfa and (d) Conditions of use. (1) For treat- clover) in pastured cattle. ment of legume (alfalfa, clover) bloat (3) Limitations. Administer free- in cattle. Administer as a drench at the choice to beef cattle and nonlactating rate of 25 grams for animals up to 500 dairy cattle only. Initially, provide one pounds and 50 grams for animals over block per five head of cattle. Start 500 pounds of body weight. treatment 10 to 14 days before exposure (2) For control of legume (alfalfa, clo- to bloat-producing pastures. Do not ver) bloat in cattle. Administer, in mo- allow cattle access to other sources of lasses block containing 6.6 percent salt while being fed this product. Do poloxalene, at the rate of 0.8 oz. of not feed this product to animals with- block (1.5 grams poloxalene) per 100 lbs. out adequate forage/roughage consump- of body weight per day. tion. (3) For prevention of legume (alfalfa, [50 FR 48189, Nov. 22, 1985, as amended at 56 clover) and wheat pasture bloat in cat- FR 9841, Mar. 8, 1991; 69 FR 62811, Oct. 28, tle. A 53-percent poloxalene top dress- 2004] ing on individual rations of ground feed. Dosage is 1 gram of poloxalene § 520.1855 Ponazuril. per 100 pounds of body weight daily. If (a) Specifications. Each gram of paste bloating conditions are severe, the dose contains 150 milligrams (mg) ponazuril. is doubled. Treatment should be start- (b) Sponsor. See No. 050604 in ed 2 to 3 days before exposure to bloat- § 510.600(c) of this chapter. producing conditions. Repeat use of the (c) Conditions of use in horses—(1) drug if animals are exposed to bloat- Amount. Administer orally 15 mg per producing conditions for more than 12 kilogram (kg) (6.81 mg per pound (lb)) hours after the last treatment. Do not body weight as the first dose, followed exceed the double dose in any 24-hour by 5 mg/kg (2.27 mg/lb) body weight period. once daily for a period of 27 additional (4) For control of legume (alfalfa, clo- days. ver) and wheat pasture bloat in cattle. (2) Indications for use. For the treat- Administer in molasses block con- ment of equine protozoal taining 6.6 percent poloxalene, at the myeloencephalitis caused by Sarcocystis rate of 0.8 ounce of block (1.5 grams of neurona.

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(3) Limitations. Do not use in horses (B) For removal of the canine cestode intended for human consumption. Fed- Echinococcus granulosus, and for re- eral law restricts this drug to use by or moval and control of the canine on the order of a licensed veterinarian. cestode Echinococcus multilocularis. [66 FR 43774, Aug. 21, 2001, as amended at 79 (iii) Limitations—(A) If labeled only FR 28827, May 20, 2014; 80 FR 34278, June 16, for use as in paragraph (c)(1)(ii)(A) of 2015; 80 FR 53459, Sept. 4, 2015] this section: Not intended for use in puppies less than 4 weeks of age. Con- § 520.1860 Pradofloxacin. sult your veterinarian before admin- (a) Specifications. Each milliliter of istering tablets to weak or debilitated suspension contains 25 milligrams (mg) animals and for assistance in the diag- pradofloxacin. nosis, treatment, and control of para- (b) Sponsor. See No. 000859 in sitism. § 510.600(c) of this chapter. (B) If labeled for use as in paragraph (c) Conditions of use in cats—(1) (c)(1)(ii)(B) of this section: Federal law Amount. Administer 3.4 mg/lb (7.5 mg/ restricts this drug to use by or on the kg) body weight once daily for 7 con- order of a licensed veterinarian. secutive days. (2) Cats—(i) Indications for use. For re- (2) Indications for use. For the treat- moval of feline cestodes Dipylidium ment of skin infections (wounds and caninum and Taenia taeniaeformis. abscesses) in cats caused by susceptible (ii) Dosage. Cats 4 pounds and under, strains of Pasteurella multocida, Strepto- 11.5 mg; 5 to 11 pounds, 23 mg; over 11 coccus canis, Staphylococcus aureus, pounds, 34.5 mg. Staphylococcus felis, and Staphylococcus (iii) Limitations. Administer directly pseudintermedius. by mouth or crumbled and in feed. Not (3) Limitations. Federal law prohibits intended for use in kittens less than 6 the extralabel use of this drug in food- weeks of age. For OTC use: Consult producing animals. Federal law re- your veterinarian before administering stricts this drug to use by or on the tablets to weak or debilitated animals, order of a licensed veterinarian. and for assistance in the diagnosis, treatment, and control of parasitism. [77 FR 76863, Dec. 31, 2012, as amended at 79 FR 28827, May 20, 2014] [46 FR 60570, Dec. 11, 1981, as amended at 47 FR 26377, June 18, 1982; 55 FR 2234, Jan. 23, § 520.1870 Praziquantel tablets. 1990; 58 FR 7864, Feb. 10, 1993; 58 FR 42853, (a) Specifications. Each tablet con- Aug. 12, 1993; 68 FR 57351, Oct. 3, 2003; 69 FR tains: 62181, Oct. 25, 2004; 78 FR 17596, Mar. 22, 2013; 81 FR 17607, Mar. 30, 2016] (1) 34 milligrams (mg) praziquantel. (2) 11.5 or 23 mg praziquantel. § 520.1871 Praziquantel and pyrantel. (b) Sponsor. See No. 069043 in § 510.600(c) of this chapter for use of the (a) Specifications. (1) Each tablet con- product described in paragraph (a)(1) of tains 13.6 milligrams (mg) praziquantel this section as in paragraph (c)(1) of and 54.3 mg pyrantel base (as pyrantel this section; and for use of the product pamoate), 18.2 mg praziquantel and 72.6 described in paragraph (a)(2) of this mg pyrantel base (as pyrantel section as in paragraph (c)(2) of this pamoate), or 27.2 mg praziquantel and section. 108.6 mg pyrantel base (as pyrantel (c) Conditions of use—(1) Dogs—(i) pamoate). Amount. 5 pounds (lb) and under, 1⁄2 tab- (2) Each chewable tablet contains 30 let (17 mg); 6 to 10 lb, 1 tablet (34 mg); mg praziquantel and 30 mg pyrantel 11 to 15 lb, 11⁄2 tablets (51 mg); 16 to 30 pamoate or 114 mg praziquantel and 114 lb, 2 tablets (68 mg); 31 to 45 lb, 3 tab- mg pyrantel pamoate. lets (102 mg); 46 to 60 lb, 4 tablets (136 (b) Sponsors. See sponsors in mg); over 60 lb, 5 tablets maximum (170 § 510.600(c) for use as in paragraph (d) of mg). Administer directly by mouth or this chapter. crumbled and in feed. (1) See No. 000859 for use of tablets (ii) Indications for use—(A) For re- described in paragraph (a)(1) of this moval of canine cestodes Dipylidium section for use as in paragraph (d)(1) of caninum and Taenia pisiformis. this section.

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(2) See No. 051311 for use of tablets (b) Sponsor. See 000859 in § 510.600(c) of described in paragraph (a)(2) of this this chapter. section for use as in paragraph (d)(2) of (c) Conditions of use—(1) Dogs—(i) this section. Amount. Administer as a single dose di- (c) Special considerations. See § 500.25 rectly by mouth or in a small amount of this chapter. of food as follows: (d) Conditions of use—(1) Cats—(i) Dos- age. Administer a minimum dose of 2.27 Weight of animal Number of tablets per dose mg praziquantel and 9.2 mg pyrantel Tablet Tablet Tablet pamoate per pound of body weight ac- Kilograms Pounds no. 1 no. 2 no. 3 cording to the dosing tables on label- 0.9 to 1.8 ...... 2 to 4 ...... 1/2. ing. May be given directly by mouth or 2.3 to 3.2 ...... 5 to 7 ...... 1. in a small amount of food. Do not with- 3.6 to 5.4 ...... 8 to 12 ..... 1 1/2. hold food prior to or after treatment. If 5.9 to 8.2 ...... 13 to 18 ... 2. reinfection occurs, treatment may be 8.6 to 11.4 .... 19 to 25 ... 2 1/2. repeated. 11.8 to 13.6 .. 26 to 30 ...... 1. (ii) Indications for use. For removal of 14.1 to 20.0 .. 31 to 44 ...... 1 1/2. 20.4 to 27.2 .. 45 to 60 ...... 2 ...... 1 tapeworms (Dipylidium caninum and 27.7 to 40.9 .. 61 to 90 ...... 1 1/2 Taenia taeniaeformis), hookworms 41.3 to 54.5 .. 91 to 120 ...... 2 (Ancylostoma tubaeforme), and large roundworms (Toxocara cati) in cats and (ii) Indications for use. For the re- kittens. moval of tapeworms (Dipylidium (iii) Limitations. Not for use in kit- caninum, Taenia pisiformis, Echinococcus tens less than 2 months of age or granulosus); hookworms (Ancylostoma weighing less than 2.0 pounds. Consult caninum, Uncinaria stenocephala); your veterinarian before giving to sick ascarids (Toxocara canis, Toxascaris or pregnant animals. leonina); and whipworms (Trichuris (2) Dogs—(i) Amount. Administer a vulpis) and for the removal and control minimum dose of 5 mg praziquantel of tapeworm Echinococcus multilocularis and 5 mg pyrantel pamoate per kilo- in dogs. gram body weight (2.27 mg praziquantel (iii) Limitations. Do not use in preg- and 2.27 mg pyrantel pamoate per nant animals. Do not use in dogs pound body weight) according to the weighing less than 0.9 kilogram (2 dosing tables on labeling. pounds) or puppies less than 3 weeks of (ii) Indications for use. For the treat- age. Federal law restricts this drug to ment and control of roundworms use by or on the order of a licensed vet- (Toxocara canis and Toxascaris leonina), erinarian. hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria [59 FR 33908, July 1, 1994, as amended at 61 stenocephala), and tapeworms FR 29651, June 12, 1996; 68 FR 22293, Apr. 28, (Dipylidium caninum and Taenia 2003; 71 FR 6677, Feb. 9, 2006] pisiformis) in dogs and puppies. § 520.1880 Prednisolone. [58 FR 58652, Nov. 3, 1993, as amended at 72 (a) Specifications. Each tablet con- FR 16270, Apr. 4, 2007; 75 FR 54018, Sept. 3, 2010] tains 5 or 20 milligrams prednisolone. (b) Sponsor. See No. 061690 in § 520.1872 Praziquantel, pyrantel § 510.600(c)(2) of this chapter. pamoate, and febantel tablets. (c) Conditions of use in dogs—(1) (a) Specifications. Each tablet or Amount. Administer 2.5 milligrams per chewable tablet contains either: 4.5 kilograms (10 pounds) body weight (1) Tablet No. 1: 22.7 milligrams per day. Administer total daily dose praziquantel, 22.7 milligrams pyrantel orally in equally divided doses 6 to 10 base, and 113.4 milligrams febantel; or hours apart until response is noted or 7 (2) Tablet No. 2: 68 milligrams days have elapsed. When response is at- praziquantel, 68 milligrams pyrantel tained, dosage should be gradually re- base, and 340.2 milligrams febantel. duced until maintenance level is (3) Tablet No. 3: 136 milligrams (mg) achieved. praziquantel, 136 mg pyrantel base, and (2) Indications for use. For use as an 680.4 mg febantel. anti-inflammatory agent.

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(3) Limitations. Federal law restricts twice daily. For dogs weighing less this drug to use by or on the order of a than 4 pounds, administer orally an ap- licensed veterinarian. propriate fraction of the contents of one of these capsules. [57 FR 4718, Feb. 7, 1992, as amended at 60 FR 57832, Nov. 22, 1995; 63 FR 148, Jan. 5, 1998; 79 (ii) Capsules described in paragraph FR 28827, May 20, 2014] (a)(2) of this section are given to dogs weighing 30 pounds and over at the rate § 520.1900 Primidone. of 1 capsule twice daily. (a) Specifications. Each tablet con- (2) Indications for use. For the treat- tains 50 or 250 milligrams of primidone. ment of gastrointestinal disturbances (b) Sponsors. See sponsor numbers in associated with emotional stress. § 510.600(c) of this chapter. (3) Limitations. Federal law restricts (1) No. 054628 for use of 250 milligram this drug to use by or on the order of a tablets. licensed veterinarian. (2) No. 054771 for use of 50 and 250 mil- [79 FR 28827, May 20, 2014] ligram tablets. (c) Conditions of use in dogs—(1) § 520.1921 Prochlorperazine, Amount. Twenty-five milligrams of isopropamide, and neomycin. primidone per pound of body weight (55 (a) Specifications. Each capsule con- milligrams per kilogram of body tains either: weight) daily. (1) Capsule No. 1: 3.33 milligrams of (2) Indications for use. For the control prochlorperazine (as the dimaleate), of convulsions associated with idio- 1.67 milligrams of isopropamide (as the pathic epilepsy, epileptiform convul- iodide), and 25 milligrams of neomycin sions, viral encephalitis, distemper, base (as the sulfate); or and hardpad disease that occurs as a (2) Capsule No. 3: 10 milligrams of clinically recognizable lesion in certain prochlorperazine (as the dimaleate), 5 entities in dogs. milligrams of isopropamide (as the io- (3) Limitations. Federal law restricts dide), and 75 milligrams of neomycin this drug to use by or on the order of a base (as the sulfate). licensed veterinarian. (b) Sponsor. See No. 054771 in [42 FR 61594, Dec. 6, 1977, as amended at 43 § 510.600(c) of this chapter. FR 55386, Nov. 28, 1978; 46 FR 8467, Jan. 27, (c) Conditions of use in dogs—(1) 1981; 46 FR 57477, Nov. 24, 1981; 53 FR 40727, Amount. Administer capsules orally Oct. 18, 1988; 56 FR 37473, Aug. 7, 1991; 62 FR twice daily to dogs as follows: 35076, June 30, 1997; 78 FR 21060, Apr. 9, 2013; 79 FR 28827, May 20, 2014] Number of capsules per dose Animal weight (pounds) § 520.1920 Prochlorperazine and Capsule Capsule isopropamide. No. 1 No. 3

(a) Specifications. Each capsules con- 10 to 20 ...... 1 tains either: 20 to 30 ...... 2 (1) 3.33 milligrams of Over 30 ...... 3 1 prochlorperazine (as the dimaleate) Over 60 ...... 2 and 1.67 milligrams of isopropamide (as (2) For the treat- the iodide); or Indications for use. (2) 10 milligrams of prochlorperazine ment infectious bacterial (as the dimaleate) and 5 milligrams of gastroenteritis associated with emo- isopropamide (as the iodide). tional stress. (b) Sponsor. See No. 054771 in (3) Limitations. Federal law restricts § 510.600(c) of this chapter. this drug to use by or on the order of a (c) Conditions of use in dogs—(1) licensed veterinarian. Amount. (i) Capsules described in para- [49 FR 14103, Apr. 10, 1984, as amended at 56 graph (a)(1) of this section are adminis- FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, tered orally to dogs weighing from 4 to 1995; 79 FR 28827, May 20, 2014] 15 pounds at the rate of 1 capsule twice daily. These capsules are administered § 520.1962 Promazine. orally to dogs weighing from 16 to 30 (a) Specifications. Conforms to N.F. pounds at the rate of 1 or 2 capsules XII for promazine hydrochloride.

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(b) Sponsor. See No. 054771 in hookworms (Ancylostoma caninum; § 510.600(c) of this chapter. Uncinaria stenocephala). (c) Conditions of use in horses—(1) (ii) In puppies and adult dogs and in Amount. Administer 0.45 to 0.9 milli- lactating bitches after whelping. To grams per pound of body weight mixed prevent reinfection of Toxocara canis. with an amount of feed that will be (3) Limitations. Administer to puppies readily consumed. at 2, 3, 4, 6, 8, and 10 weeks of age. Ad- (2) Indications for use. For quieting minister to lactating bitches 2 to 3 excitable, unruly, or intractable weeks after whelping. Retreatment of horses. adult dogs may be necessary at month- (3) Limitations. Do not use in horses ly intervals as determined by labora- intended for human consumption. Fed- eral law restricts this drug to use by or tory fecal examinations. Consult your on the order of a licensed veterinarian. veterinarian for assistance in the diagnosis, treatment, and control of para- [79 FR 28827, May 20, 2014] sitism. § 520.2002 Propiopromazine. [52 FR 37937, Oct. 13, 1987, as amended at 57 (a) Specifications. Each chewable tab- FR 48163, Oct. 22, 1992; 58 FR 44611, Aug. 24, let contains 10 or 20 milligrams of 1993; 66 FR 9650, Feb. 9, 2001; 67 FR 21996, May 2, 2002; 81 FR 22523, Apr. 18, 2016; 82 FR 12169, propiopromazine hydrochloride. Mar. 1, 2017] (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 520.2042 Pyrantel pamoate tablets. (c) Conditions of use in dogs—(1) Amount. Administer 0.5 to 2.0 milli- (a) Specifications. Each tablet con- grams per pound of body weight once tains pyrantel pamoate equivalent to or twice daily, depending upon the de- 22.7, 45.4, or 113.5 milligrams of gree of tranquilization desired. pyrantel base. (2) Indications for use. For oral admin- (b) Sponsor. See No. 017135 in istration as a tranquilizer. As an aid in § 510.600(c) of this chapter. handling difficult, excited, and unruly (c) Conditions of use. It is used for dogs, and in controlling excessive ken- dogs as follows: nel barking, car sickness, and severe (1) Amount. For dogs weighing over 5 dermatitis. It is also indicated for use pounds, use at least 2.27 milligrams of in minor surgery and prior to routine pyrantel base per pound of body examinations, laboratory procedures, weight; for dogs weighing 5 pounds or and diagnostic procedures. less, use at least 4.54 milligrams of (3) Limitations. Federal law restricts pyrantel base per pound of body this drug to use by or on the order of a weight. licensed veterinarian. (2) Indications for use. For removal [79 FR 28827, May 20, 2014] and control of large roundworms (ascarids) (Toxocara canis and § 520.2041 Pyrantel pamoate chewable Toxascaris leonina), and hookworms tablets. (Ancylostoma caninum and Uncinaria (a) Specifications. Each tablet con- stenocephala). tains pyrantel pamoate equivalent to (3) Limitations. Administer orally di- 22.7 or 113.5 milligrams pyrantel base. rectly or in a small amount of food. To (b) Sponsor. See Nos. 066916, 017135, prevent reinfection of T. canis in pup- and 051311 in § 510.600(c) of this chapter. pies, lactating bitches after whelping, (c) Conditions of use—(1) Amount. Pro- vides at least 2.27 milligrams pyrantel and adult dogs; treat puppies 2, 3, 4, 6, base per pound body weight for dogs 8, and 10 weeks of age; treat lactating weighing more than 5 pounds, and at bitches 2 to 3 weeks after whelping; least 4.54 milligrams of pyrantel base routinely treat adult dogs monthly. Do per pound body weight for dogs weigh- not withhold food prior to or after ing 5 pounds or less. treatment. The presence of these (2) Indications for use—(i) In dogs and parasites should be confirmed by lab- puppies. For removal of ascarids oratory fecal examination. A followup (Toxocara canis; Toxascaris leonina) and fecal examination should be conducted

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2 to 4 weeks after first treatment regi- (i) Dogs and puppies—(A) Amount. 2.27 men to determine the need for re-treat- mg/lb body weight as a single dose in ment. Consult your veterinarian for as- the animal’s feed bowl by itself or sistance in the diagnosis, treatment, mixed in a small quantity of food. and control of parasitism. (B) Indications for use. For the re- [43 FR 52700, Nov. 14, 1978, as amended at 49 moval of large roundworms (Toxocara FR 22073, May 25, 1984; 57 FR 48163, Oct. 22, canis and Toxascaris leonina) and 1992; 58 FR 44611, Aug. 24, 1993] hookworms (Ancylostoma caninum and Uncinaria stenocephala). § 520.2043 Pyrantel pamoate suspen- (C) Limitations. Additional treatment sion. may be required and should be con- (a) Specifications. (1) Each milliliter firmed by fecal examination within 2 (mL) contains pyrantel pamoate equiv- to 4 weeks. alent to 50 milligrams (mg) pyrantel (ii) Dogs, puppies, and lactating bitches base. after whelping—(A) Amount. 2.27 mg/lb (2) Each mL contains pyrantel body weight. pamoate equivalent to 2.27 or 4.54 mg (B) Indications for use. To prevent re- pyrantel base. infections of T. canis. (3) Each mL contains pyrantel (C) Limitations. Administer to puppies pamoate equivalent to 4.54 mg pyrantel at 2, 3, 4, 6, 8, and 10 weeks of age. Ad- base. minister to lactating bitches 2 to 3 (b) Sponsors. See sponsors in weeks after whelping. Adult dogs kept § 510.600(c) of this chapter for uses as in in heavily contaminated quarters may paragraph (d) of this section. be treated at monthly intervals. (1) Nos. 054771, 058829, and 069043 for use of the product described in para- [67 FR 43248, June 27, 2002, as amended at 68 graph (a)(1) as in paragraph (d)(1) of FR 54803, Sept. 19, 2003; 68 FR 55199, Sept. 23, this section. 2003; 68 FR 55825, Sept. 29, 2003; 75 FR 52622, Aug. 27, 2010; 76 FR 17337, Mar. 29, 2011; 78 FR (2) Nos. 000859, 054771, and 058829 for 17596, Mar. 22, 2013; 79 FR 28827, May 20, 2014; use of the products described in para- 80 FR 76386, Dec. 9, 2015; 81 FR 17607, Mar. 30, graph (a)(2) as in paragraph (d)(2) of 2016] this section. (3) No. 023851 for use of the product § 520.2044 Pyrantel pamoate paste. described in paragraph (a)(3) as in para- (a) Specifications—(1) Each milliliter graph (d)(2) of this section. (mL) contains 180 milligrams (mg) (c) Special considerations. See § 500.25 pyrantel base (as pyrantel pamoate). of this chapter. (2) Each mL contains 226 mg pyrantel (d) Conditions of use—(1) Horses and base (as pyrantel pamoate). ponies. It is used as follows: (3) Each mL contains 171 mg pyrantel (i) Amount. 3 mg per pound (/lb) body base (as pyrantel pamoate). weight as a single dose mixed with the usual grain ration, or by stomach tube (b) Sponsors. See sponsors in or dose syringe. § 510.600(c) of this chapter. (ii) Indications for use. For the re- (1) No. 054771 for use of product de- moval and control of mature infections scribed in paragraph (a)(1) of this sec- of large strongyles (Strongylus vulgaris, tion as in paragraph (d)(1)(i) and (d)(2) S. edentatus, S. equinus); pinworms of this section. (Oxyuris equi); large roundworms (2) No. 017135 for use of product de- (Parascaris equorum); and small scribed in paragraph (a)(2) of this sec- strongyles. tion as in paragraph (d) of this section. (iii) Limitations. Do not use in horses (3) No. 061623 for use of product de- intended for human consumption. scribed in paragraph (a)(3) of this sec- When the drug is for administration by tion as in paragraph (d)(1)(i) and (d)(2) stomach tube, it shall be labeled: of this section. ‘‘Federal law restricts this drug to use (c) Special considerations. See § 500.25 by or on the order of a licensed veteri- of this chapter. narian.’’ (d) Conditions of use. It is used in (2) Dogs. It is used as follows: horses and ponies as follows:

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(1) Amounts and indications for use—(i) (ii) Indications for use. For the re- 3 mg per pound (/lb) body weight as sin- moval and control of large roundworms gle oral dose for removal and control of (Ascaris suum) and nodular worm infections from the following mature (Oesophagostomum) infections. parasites: large strongyles (Strongylus (iii) Limitations. Consult veterinarian vulgaris, S. edentatus, S. equinus); small before using in severely debilitated strongyles; pinworms (Oxyuris equi); animals. Do not treat within 24 hours and large roundworms (Parascaris of slaughter. equorum). (ii) 6 mg/lb body weight as single oral [79 FR 28827, May 20, 2014] dose for the removal and control of ma- § 520.2046 Pyrantel tartrate pellets. ture infections of tapeworms (Anoplocephala perfoliata). (a) Specifications. (1) Each gram of (2) Limitations. Do not use in horses pellets contains 12.5 milligrams (mg) intended for human consumption. (1.25 percent) pyrantel tartrate; or (2) Each gram of pellets contains 21.1 [70 FR 29447, May 23, 2005, as amended at 76 mg (2.11 percent) pyrantel tartrate. FR 17337, Mar. 29, 2011; 78 FR 17596, Mar. 22, 2013; 79 FR 28827, May 20, 2014; 81 FR 17607, (b) Sponsors. See sponsor numbers in Mar. 30, 2016] § 510.600(c) of this chapter: (1) No. 054771 for use of products de- § 520.2045 Pyrantel tartrate powder. scribed in paragraph (a) as in para- (a) Specifications. Each gram of pow- graph (c) of this section. der contains 106 milligrams (10.6 per- (2) No. 061623 for use of product de- cent) or 113 milligrams (11.3 percent) scribed in paragraph (a)(1) as in para- pyrantel tartrate. graph (c) of this section. (b) Sponsor. See No. 054771 in (c) Conditions of use in horses—(1) § 510.600(c) of this chapter for use of 11.3 Amount. Administer as a single dose at percent powder as in paragraph (d)(1) 12.5 mg per 2.2 pounds of body weight and 10.6 percent powder as in paragraph mixed with the usual grain ration. (d)(2) and of this section. (2) Indications for use. For the re- (c) Related tolerances. See § 556.560 of moval and control of infections from this chapter. the following mature parasites: Large (d) Conditions of use—(1) Horses—(i) strongyles (Strongylus vulgaris, S. Amount. Administer as a single dose at edentatus, S. equinus), small strongyles 0.57 gram of pyrantel tartrate per 100 (Trichonema spp., Triodontophorus), pounds of body weight mixed with the pinworms (Oxyuris), and large usual grain ration. Do not administer roundworms (Parascaris). by stomach tube or dose syringe. (3) Limitations. Do not treat severely (ii) Indications for use. For the re- debilitated animals with this drug. Do moval and control of infections from not use in horses intended for human the following mature parasites: Large consumption. strongyles (Strongylus vulgaris, S. edentatus, S. equinus), small strongyles [79 FR 28828, May 20, 2014] (Trichonema spp., Triodontophorus), § 520.2075 Robenacoxib. pinworms (Oxyuris), and large roundworms (Parascaris). (a) Specifications. Each tablet con- (iii) Limitations. Do not treat severely tains 10, 20, or 40 milligrams (mg) debilitated animals with this drug. Do robenacoxib for use in dogs, or 6 mg not use in horses intended for human robenacoxib for use in cats. consumption. (b) Sponsors. See No. 058198 in (2) Swine—(i) Amount. Add to feed at § 510.600(c) of this chapter. 0.4 gram pyrantel tartrate per pound of (c) Conditions of use—(1) Dogs—(i) non-pelleted ration. The ration is ad- Amount. Administer 0.91 mg/lb (2 mg/ ministered as a single treatment as the kg) orally, once daily, for a maximum sole ration at the rate of 1 pound per 40 of 3 days. pounds of animal weight for animals up (ii) Indications for use. For the control to 200 pounds. Animals 200 pounds and of postoperative pain and inflamma- over are administered 5 pounds of ration associated with soft tissue surgery tion per animal. in dogs weighing at least 5.5 lb (2.5 kg)

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and at least 4 months of age for a max- minister 1 mg per kilogram (0.45 mg imum of 3 days. per pound) of body weight once daily (iii) Limitations. Federal law restricts for control of clinical signs associated this drug to use by or on the order of a with uncomplicated pituitary-depend- licensed veterinarian. ent hyperadrenocorticism in dogs. (2) Cats—(i) Amount. Administer 0.45 (ii) Administer 0.5 to 1.0 mg per kilo- mg/lb (1 mg/kg) orally, once daily, for a gram of body weight once daily for the maximum of 3 days. control of clinical signs associated (ii) Indications for use. For the control with canine cognitive dysfunction syn- of postoperative pain and inflammation associated with orthopedic sur- drome. gery, ovariohysterectomy, and castra- (2) Limitations. Federal law restricts tion in cats weighing at least 5.5 lb (2.5 this drug to use by or on the order of a kg) and at least 4 months of age for a licensed veterinarian. maximum of 3 days. [79 FR 28828, May 20, 2014] (iii) Limitations. Federal law restricts this drug to use by or on the order of a § 520.2100 Selenium and vitamin E. licensed veterinarian. (a) Specifications. Each capsule con- [76 FR 18648, Apr. 5, 2011, as amended at 79 tains: FR 10964, Feb. 27, 2014; 81 FR 59133, Aug. 29, 2016] (1) 2.19 milligrams (mg) sodium selenite (equivalent to 1 mg selenium) and § 520.2086 Sarolaner. 56.2 mg (68 I.U.) vitamin E as d-alpha (a) Specifications. Each chewable tab- tocopheryl acid succinate; or let contains 5, 10, 20, 40, 80, or 120 milli- (2) 0.548 mg sodium selenite (equiva- grams (mg) sarolaner. lent to 0.25 mg selenium) and 14 mg (17 (b) Sponsor. See No. 054771 in I.U.) vitamin E as d-alpha tocopheryl § 510.600(c) of this chapter. acid succinate. (c) Conditions of use in dogs—(1) (b) Sponsor. See No. 000061 in Amount. Administer orally once a § 510.600(c) of this chapter. month at the recommended minimum (c) Conditions of use in dogs—(1) dosage of 0.9 mg/lb (2 mg/kg). Amount. (i) Dogs over 20 pounds: Ad- (2) Indications for use. Kills adult minister 1 capsule described in para- fleas, and for the treatment and pre- graph (a)(1) per 20 pounds of body vention of flea infestations weight to a maximum of 5 capsules. Re- (Ctenocephalides felis), and the treat- peat at 3 day intervals until a satisfac- ment and control of tick infestations [Amblyomma americanum (lone star tory therapeutic response is observed. tick), Amblyomma maculatum (Gulf Maintenance dosage is 1 capsule per 40 Coast tick), Dermacentor variabilis pounds of body weight every 3 to 7 (American dog tick), Ixodes scapularis days, or longer, as required. (black-legged tick), and Rhipicephalus (ii) Dogs under 20 pounds: Administer sanguineus (brown dog tick)] for 1 1 capsule described in paragraph (a)(2) month in dogs 6 months of age or older per 5 pounds of body weight with a and weighing 2.8 pounds or greater. minimum of 1 capsule. Repeat at 3-day (3) Limitations. Federal law restricts intervals until a satisfactory response this drug to use by or on the order of a is observed. Maintenance dosage is 1 licensed veterinarian. capsule per 10 pounds of body weight [81 FR 22523, Apr. 18, 2016, as amended at 82 every 3 to 7 days, or longer, as re- FR 12169, Mar. 1, 2017] quired. (2) Indications for use. As an aid in al- § 520.2098 Selegiline. leviating and controlling inflamma- (a) Specifications. Each tablet con- tion, pain, and lameness associated tains 2, 5, 10, 15, or 30 milligrams (mg) with certain arthropathies. selegiline hydrochloride. (3) Limitations. Federal law restricts (b) Sponsor. See No. 054771 in this drug to use by or on the order of a § 510.600(c) of this chapter. licensed veterinarian. (c) Conditions of use in dogs—(1) Amounts and indications for use. (i) Ad- [79 FR 28828, May 20, 2014]

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§ 520.2123 Spectinomycin oral dosage § 520.2123c Spectinomycin solution. forms. (a) Specifications. Each milliliter of § 520.2123a Spectinomycin tablets. solution contains spectinomycin dihydrochloride pentahydrate equiva- (a) Specifications. Each tablet con- lent to 50 milligrams (mg) tains spectinomycin dihydrochloride equivalent to 100 milligrams (mg) spectinomycin. spectinomycin. (b) Sponsors. See Nos. 016592, 054771, (b) Sponsors. See Nos. 054771 and and 061623 in § 510.600(c) of this chapter. 061623 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.600 of (c) Conditions of use in dogs—(1) this chapter. Amount. Administer orally to provide (d) Conditions of use in swine—(1) 10 mg per pound (lb) of body weight Amount. Administer 5 mg per pound (lb) twice daily. Dosage may be continued of body weight orally twice daily for 3 for 4 consecutive days. to 5 days. (2) Indications for use. For the treat- (2) Indications for use. For the treatment of infectious diarrhea and ment and control of porcine enteric gastroenteritis caused by organisms colibacillosis (scours) caused by E. coli susceptible to spectinomycin. susceptible to spectinomycin in pigs (3) Limitations. Federal law restricts under 4 weeks of age. this drug to use by or on the order of a (3) Limitations. Do not administer to licensed veterinarian. pigs over 15 lb body weight or over 4 [73 FR 6607, Feb. 5, 2008, as amended at 79 FR weeks of age. Do not administer within 28828, May 20, 2014] 21 days of slaughter. § 520.2123b Spectinomycin powder. [73 FR 6607, Feb. 5, 2008, as amended at 78 FR 17596, Mar. 22, 2013; 79 FR 28828, May 20, 2014; (a) Specifications. Each gram (g) of 81 FR 22523, Apr. 18, 2016] powder contains spectinomycin dihydrochloride pentahydrate equiva- § 520.2130 Spinosad. lent to 0.5 g spectinomycin. (b) Sponsor. See No. 061623 in (a) Specifications. Each chewable tab- § 510.600(c) of this chapter. let contains 90, 140, 270, 560, 810, or 1620 (c) Related tolerances. See § 556.600 of milligrams (mg) spinosad. this chapter. (b) Sponsor. See No. 058198 in § 510.600 (d) Conditions of use in chickens. It is of this chapter. administered in the drinking water of (c) Special considerations. Federal law growing chickens as follows: restricts this drug to use by or on the (1) Indications for use and amounts—(i) order of a licensed veterinarian. As an aid in controlling infectious syn- (d) Conditions of use—(1) Dogs—(i) ovitis due to Mycoplasma synoviae in Amount. Administer tablets once a broiler chickens, administer 1 g per month at a recommended minimum gallon of water as the only source of dosage of 13.5 mg per pound (30 mg per drinking water for the first 3 to 5 days kilogram) of body weight. of life. (ii) Indications for use. To kill fleas (ii) As an aid in the prevention or and for the prevention and treatment control of losses due to CRD associated of flea infestations (Ctenocephalides with M. gallisepticum (PPLO) in growing chickens, administer 2 g per gallon felis) for 1 month on dogs and puppies of water as the only source of drinking 14 weeks of age and older and 3.3 water for the first 3 days of life and for pounds of body weight or greater. 1 day following each vaccination. (2) Cats—(i) Amount. Administer tab- (2) Limitations. Do not administer to lets once a month at a minimum dos- laying chickens. Do not administer age of 22.5 mg per pound (50 mg per within 5 days of slaughter. Federal law kilogram) of body weight. restricts this drug to use by or on the (ii) Indications for use. To kill fleas order of a licensed veterinarian. and for the prevention and treatment [73 FR 6607, Feb. 5, 2008, as amended at 81 FR of flea infestations (C. felis) for 1 month 94990, Dec. 27, 2016] on cats and kittens 14 weeks of age and

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older and 2 pounds of body weight or (2) Indications for use. As an anabolic greater. steroid treatment. (3) Limitations. Federal law restricts [77 FR 60623, Oct. 4, 2012, as amended at 81 FR 48702, July 26, 2016] this drug to use by or on the order of a licensed veterinarian. § 520.2134 Spinosad and milbemycin. [79 FR 28828, May 20, 2014] (a) Specifications. Each chewable tablet contains 140 milligrams (mg) § 520.2158 Streptomycin. spinosad and 2.3 mg milbemycin oxime, (a) Specifications. Each milliliter of 270 mg spinosad and 4.5 mg milbemycin solution contains 250 milligrams (25 oxime, 560 mg spinosad and 9.3 mg percent) streptomycin sulfate. milbemycin oxime, 810 mg spinosad (b) Sponsor. See No. 016592 in and 13.5 mg milbemycin oxime, or 1,620 § 510.600(c) of this chapter. mg spinosad and 27 mg milbemycin (c) Related tolerances. See § 556.610 of oxime. this chapter. (b) Sponsor. See No. 058198 in § 510.600 (d) Conditions of use. Use in drinking of this chapter. water as follows: (c) Conditions of use in dogs—(1) (1) Calves—(i) Amount. 10 to 15 milli- Amount. Administer once a month at a grams per pound (mg/pound) of body minimum dosage of 13.5 mg/pound (lb) weight (1.0 to 1.5 grams per gallon) for (30 mg/kilogram (kg)) of body weight up to 5 days. spinosad and 0.2 mg/lb (0.5 mg/kg) of (ii) Indications for use. For the treat- body weight milbemycin oxime. ment of bacterial enteritis caused by (2) Indications for use. To kill fleas; Escherichia coli and Salmonella spp. sus- for the prevention and treatment of ceptible to streptomycin. flea infestations (Ctenocephalides felis); (iii) Limitations. Federal law restricts for the prevention of heartworm dis- this drug to use by or on the order of a ease (Dirofilaria immitis); and for the licensed veterinarian. treatment and control of adult hookworm (Ancylostoma caninum), (2) Swine—(i) Amount. 10 to 15 mg/ adult roundworm (Toxocara canis and pound of body weight (1.0 to 1.5 grams Toxascaris leonina), and adult per gallon) for up to 4 days. whipworm (Trichuris vulpis) infections (ii) Indications for use. For the treat- in dogs and puppies 8 weeks of age or ment of bacterial enteritis caused by older and 5 lbs of body weight or great- Escherichia coli and Salmonella spp. sus- er. ceptible to streptomycin. (3) Limitations. Federal law restricts (iii) Limitations. Federal law restricts this drug to use by or on the order of a this drug to use by or on the order of a licensed veterinarian. licensed veterinarian. (3) Chickens—(i) Amount. 10 to 15 mg/ [76 FR 12563, Mar. 8, 2011, as amended at 81 pound of body weight (0.6 to 0.9 grams FR 48702, July 26, 2016] per gallon) for up to 5 days. (ii) Indications for use. For the treat- § 520.2150 Stanozolol. ment of nonspecific infectious enteritis (a) Specifications. Each tablet or caused by organisms susceptible to chewable tablet contains 2 milligrams streptomycin. stanozolol. (iii) Limitations. Withdraw 4 days be- (b) Sponsor. No. 054771 in § 510.600(c) of fore slaughter. Do not administer to this chapter. chickens producing eggs for human (c) Conditions of use in dogs and cats— consumption. Federal law restricts this (1) Amount—(i) Dogs: Administered drug to use by or on the order of a li- orally to small breeds, 1⁄2 to 1 tablet censed veterinarian. twice daily for several weeks; to large breeds, 1 to 2 tablets twice daily for [57 FR 37327, Aug. 18, 1992, as amended at 58 several weeks. The tablets may be FR 47211, Sept. 8, 1993; 63 FR 51821, Sept. 29, 1998. Redesignated and amended at 79 FR crushed and administered in feed. 28828, May 20, 2014; 79 FR 74020, Dec. 15, 2014; (ii) Cats: Administered orally 1⁄2 to 1 80 FR 18776, Apr. 8, 2015; 80 FR 61296, Oct. 13, tablet twice daily for several weeks. 2015]

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§ 520.2170 Sulfabromomethazine. § 520.2200 Sulfachlorpyridazine. (a) Specifications. Each bolus contains (a) Specifications. (1) Sodium 15 grams of sulfabromomethazine so- sulfachlorpyridazine powder. dium. (2) Each bolus contains 2 grams (b) Sponsor. See No. 050604 in sulfachlorpyridazine. § 510.600(c) of this chapter. (3) Each tablet contains 250 milli- (c) Related tolerance. See § 556.620 of grams (mg) sulfachlorpyridazine. this chapter. (b) Sponsor. See No. 016592 in (d) Conditions of use in cattle—(1) § 510.600(c) of this chapter. Amount. Administer 90 milligrams per (c) Related tolerances. See § 556.630 of pound body weight orally. Repeat in 48 this chapter. hours if necessary (d) Conditions of use. It is used as fol- (2) Indications for use. Treatment of lows: necrotic pododermatitis (foot rot) and (1) Calves—(i) Amount. Administer 30 calf diphtheria caused by Fusobacterium to 45 mg sulfachlorpyridazine powder necrophorum; colibacillosis (scours) per pound (/lb) of body weight per day caused by Escherichia coli; bacterial in milk or milk replacer, or in a bolus, pneumonia and bovine respiratory dis- in divided doses twice daily for 1 to 5 ease complex (shipping fever complex) days. associated with Pasteurella spp.; acute (ii) Indications for use. For the treat- metritis and acute mastitis caused by ment of diarrhea caused or complicated Streptococcus spp. by Escherichia coli (colibacillosis). (3) Limitations. Milk taken from ani- (iii) Limitations. Treated ruminating calves must not be slaughtered for food mals within 96 hours (8 milkings) of during treatment or for 7 days after latest treatment must not be used for the last treatment. A withdrawal pe- food. Do not administer within 18 days riod has not been established for this of slaughter. product in preruminating calves. Do [47 FR 30243, July 13, 1982, as amended at 62 not use in calves to be processed for FR 63270, Nov. 28, 1997; 79 FR 28829, May 20, veal. Federal law restricts this drug to 2014] use by or on the order of a licensed veterinarian. § 520.2184 Sulfachloropyrazine. (2) Swine—(i) Amount. Administer 20 (a) Specifications. Each gram of pow- to 35 mg/lb body weight per day, in di- der contains 476 milligrams of sodium vided doses twice daily for 1 to 5 days: sulfachloropyrazine monohydrate. (A) In drinking water or (b) Sponsor. See No. 054771 in (B) For individual treatment, in an § 510.600(c) of this chapter. oral suspension containing 50 mg per (c) Related tolerance. See § 556.625 of milliliter. this chapter. (ii) Indications for use. For the treat- (d) Conditions of use in chickens. It is ment of diarrhea caused or complicated used in the drinking water of broilers, by E. coli (colibacillosis). breeder flocks, and replacement chick- (iii) Limitations. Treated swine must ens as follows: not be slaughtered for food during (1) Amount. Administer in drinking treatment or for 4 days after the last water as 0.03 percent solution for 3 treatment. Federal law restricts this days. drug to use by or on the order of a licensed veterinarian. (2) Indications for use. For the treat- (3) Dogs—(i) Amount. Administer tab- ment of coccidiosis. lets orally at 500 mg per 10 to 15 lb of (3) Limitations. Withdraw 4 days prior body weight daily, in two or three di- to slaughter. Do not use in chickens vided doses. producing eggs for human consump- (ii) Indications for use. As an aid in tion. Federal law restricts this drug to the treatment of infectious use by or on the order of a licensed vet- tracheobronchitis and infections erinarian. caused by E. coli, and in the treatment [79 FR 28829, May 20, 2014, as amended at 81 of infections caused by other Gram- FR 94990, Dec. 27, 2016] positive and Gram-negative organisms

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that are susceptible to sulfonamide (B) As an aid in the control of acute therapy. fowl cholera caused by Pasteurella (iii) Limitations. Federal law restricts multocida susceptible to sulfamerazine, this drug to use by or on the order of a sulfamethazine, and sulfaquinoxaline: licensed veterinarian. Provide medicated water (0.04 percent solution) for 2 to 3 days. If disease re- [75 FR 10166, Mar. 5, 2010, as amended at 79 FR 28829, May 20, 2014; 81 FR 17607, Mar. 30, curs, repeat treatment. 2016; 81 FR 94990, Dec. 27, 2016] (ii) Limitations. Do not treat chickens within 14 days of slaughter for food. Do not medicate chickens producing eggs § 520.2215 Sulfadiazine/pyrimethamine for human consumption. Federal law suspension. restricts this drug to use by or on the (a) Specifications. Each milliliter order of a licensed veterinarian. (mL) of suspension contains 250 milli- (2) Turkeys—(i) Amounts and indica- grams (mg) sulfadiazine (as the sodium tions for use—(A) As an aid in the con- salt) and 12.5 mg pyrimethamine. trol of coccidiosis caused by Eimeria (b) Sponsor. See No. 055246 in meleagrimitis and E. adenoeides suscep- § 510.600(c) of this chapter. tible to sulfamerazine, sulfamethazine, (c) Conditions of use in horses—(1) and sulfaquinoxaline: Provide medi- Amount. Administer orally 20 mg sulfa- cated water (0.025 percent solution) for diazine per kilogram (kg) body weight 2 days, then plain water for 3 days, and 1 mg/kg pyrimethamine daily. then medicated water (0.025 percent so- (2) Indications for use. For the treat- lution) for 2 days, then plain water for ment of equine protozoal 3 days, then medicated water (0.025 per- myeloencephalitis (EPM) caused by cent solution) for 2 days. Repeat if nec- Sarcocystis neurona. essary. Do not change litter. (3) Limitations. Do not use in horses (B) As an aid in the control of acute intended for human consumption. Fed- fowl cholera caused by Pasteurella eral law restricts this drug to use by or multocida susceptible to sulfamerazine, on the order of a licensed veterinarian. sulfamethazine, and sulfaquinoxaline: Provide medicated water (0.04 percent [69 FR 70054, Dec. 2, 2004, as amended at 73 solution) for 2 to 3 days. If disease re- FR 53686, Sept. 17, 2008; 75 FR 69586, Nov. 15, 2010] curs, repeat treatment. (ii) Limitations. Do not treat turkeys § 520.2218 Sulfamerazine, within 14 days of slaughter for food. Do sulfamethazine, and not medicate turkeys producing eggs sulfaquinoxaline powder. for human consumption. Federal law (a) Specifications. Each 195-gram (g) restricts this drug to use by or on the packet of powder contains 78 g sulfa- order of a licensed veterinarian. merazine, 78 g sulfamethazine, and 39 g [71 FR 13001, Mar. 14, 2006, as amended at 79 sulfaquinoxaline. FR 28829, May 20, 2014; 80 FR 34278, June 16, (b) Sponsor. See No. 016592 in 2015; 81 FR 22523, Apr. 18, 2016; 81 FR 94990, § 510.600(c) of this chapter. Dec. 27, 2016] (c) Related tolerances. See §§ 556.670 and 556.685 of this chapter. § 520.2220 Sulfadimethoxine oral dos- (d) Conditions of use—(1) Chickens—(i) age forms. Amounts and indications for use—(A) As an aid in the control of coccidiosis § 520.2220a Sulfadimethoxine oral solution and soluble powder. caused by Eimeria tenella and E. necatrix susceptible to sulfamerazine, (a) Specifications. (1) Each ounce of sulfamethazine, and sulfaquinoxaline: solution contains 3.75 grams (12.5 per- Provide medicated water (0.04 percent cent) sulfadimethoxine. solution) for 2 to 3 days, then plain (2) Each 107 grams of powder contains water for 3 days, then medicated water the equivalent of 94.6 grams (0.025 percent solution) for 2 days. If sulfadimethoxine as sulfadimethoxine bloody droppings appear, repeat at 0.025 sodium. percent level for 2 more days. Do not (b) Sponsors. See sponsor numbers in change litter. § 510.600(c) of this chapter:

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(1) Nos. 016592, 054628, 054771, 054925, Federal law prohibits the extralabel and 057561 for use of the product de- use of this product in lactating dairy scribed in paragraph (a)(1) of this sec- cattle. tion. [79 FR 28829, May 20, 2014, as amended at 81 (2) Nos. 054771, 054925, 057561, 058829, FR 22523, Apr. 18, 2016; 81 FR 94990, Dec. 27, 061623, and 066104 for use of the product 2016] described in paragraph (a)(2) of this section. § 520.2220b Sulfadimethoxine suspen- (c) Related tolerances. See § 556.640 of sion. this chapter. (a) Specifications. Each milliliter of (d) Conditions of use—(1) Broiler and suspension contains 50 milligrams (mg) replacement chickens—(i) Amount. Ad- sulfadimethoxine. minister 1.875 grams per gallon (0.05 (b) Sponsors. See Nos. 000061 and percent) of drinking water for 6 con- 054771 in § 510.600(c) of this chapter. secutive days. (c) Conditions of use in dogs and cats— (ii) Indications for use. For treatment (1) Amount. Administer orally 25 mg per of outbreaks of coccidiosis, fowl chol- pound of body weight, followed by 12.5 era, and infectious coryza. mg per pound of body weight daily. (iii) Limitations. Withdraw 5 days be- (2) Indications for use. For the treat- fore slaughter. Federal law restricts ment of sulfonamide susceptible bac- this drug to use by or on the order of a terial infections in dogs and cats and licensed veterinarian. enteritis associated with coccidiosis in (2) Turkeys—(i) Amount. Administer dogs. 0.938 grams per gallon (0.025 percent) of (3) Limitations. Federal law restricts drinking water for 6 consecutive days. this drug to use by or on the order of a (ii) Indications for use. Growing tur- licensed veterinarian. keys: For treatment of disease outbreaks of coccidiosis and fowl cholera. [79 FR 28829, May 20, 2014] (iii) Limitations. Withdraw 5 days before slaughter. Federal law restricts § 520.2220c Sulfadimethoxine tablet. this drug to use by or on the order of a (a) Specifications. Each tablet con- licensed veterinarian. tains 125, 250, or 500 milligrams (mg) (3) Cattle—(i) Amount. 1.18 to 2.36 sulfadimethoxine. grams per gallon (0.031 to 0.062 percent) (b) Sponsors. See Nos. 000061 and of drinking water. As a drench, admin- 054771 in § 510.600(c) of this chapter. ister 2.5 grams per 100 pounds of body (c) [Reserved] weight for first day, then 1.25 grams (d) Conditions of use in dogs and cats— per 100 pounds of body weight per day (1) Amount. Administer 25 milligrams for the next 4 consecutive days. If no (mg) per pound of body weight on the improvement within 2 to 3 days, re- first day followed by 12.5 milligrams evaluate diagnosis. Do not treat be- (mg) per pound of body weight per day yond 5 days. until the animal is free of symptoms (ii) Indications for use. Dairy calves, for 48 hours. dairy heifers, and beef cattle: For the (2) Indications for use. Treatment of treatment of shipping fever complex sulfadimethoxine-susceptible bacterial and bacterial pneumonia associated infections. with Pasteurella spp. sensitive to (3) Limitations. Federal law restricts sulfadimethoxine; and calf diphtheria this drug to use by or on the order of a and foot rot associated with licensed veterinarian. Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive [79 FR 28829, May 20, 2014] to sulfadimethoxine. (iii) Limitations. Withdraw 7 days be- § 520.2220d Sulfadimethoxine bolus. fore slaughter. A withdrawal period has (a) Specifications. Each bolus contains not been established for this product in 2.5, 5, or 15 grams sulfadimethoxine. preruminating calves. Do not use in (b) Sponsor. See No. 054771 in calves to be processed for veal. Federal § 510.600(c) of this chapter. law restricts this drug to use by or on (c) Related tolerances. See § 556.640 of the order of a licensed veterinarian. this chapter.

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(d) Conditions of use in cattle—(1) § 520.2220f Sulfadimethoxine and Amount. Administer 2.5 grams per 100 ormetoprim tablet. pounds body weight for 1 day followed (a) Specifications. Each tablet con- by 1.25 grams per 100 pounds body tains 120 milligrams (mg) (100 mg weight per day; treat for 4 to 5 days. sulfadimethoxine and 20 mg (2) Indications for use. For the treat- ormetoprim), 240 mg (200 mg ment of shipping fever complex and sulfadimethoxine and 40 mg bacterial pneumonia associated with ormetoprim), 600 mg (500 mg Pasteurella spp. sensitive to sulfadimethoxine and 100 mg sulfadimethoxine; and calf diphtheria ormetoprim), or 1200 mg (1000 mg and foot rot associated with sulfadimethoxine and 200 mg Fusobacterium necrophorum sensitive to ormetoprim). sulfadimethoxine. (b) Sponsor. See No. 054771 in (3) Limitations. Do not administer § 510.600(c) of this chapter. within 7 days of slaughter; milk that (c) Conditions of use in dogs—(1) has been taken from animals during Amount. On the first day of treatment, treatment and 60 hours (5 milkings) administer 25 mg per pound (55 mg per after the latest treatment must not be kilogram) of body weight. Then follow used for food. A withdrawal period has with a daily dosage of 12.5 mg per pound (27.5 mg per kilogram) of body not been established for this product in weight. Do not exceed a total of 21 con- preruminating calves. Do not use in secutive days. calves to be processed for veal. (2) Indications of use. Treatment of [79 FR 28829, May 20, 2014] skin and soft tissue infections (wounds and abscesses) in dogs caused by § 520.2220e Sulfadimethoxine ex- strains of Staphylococcus aureus and tended-release bolus. Escherichia coli and urinary tract infec- (a) Specifications. Each extended-re- tions caused by E. coli, Staphylococcus lease bolus contains 12.5 grams spp., and Proteus mirabilus susceptible sulfadimethoxine. to ormetoprim-potentiated sulfadimethoxine. (b) Sponsor. See No. 054771 in (3) Limitations. Federal law restricts § 510.600(c) of this chapter. this drug to use by or on the order of a (c) Related tolerances. See § 556.640 of licensed veterinarian. this chapter. (d) Conditions of use in beef cattle and [79 FR 28830, May 20, 2014] non-lactating dairy cattle—(1) Amount. § 520.2240 Sulfaethoxypyridazine. Administer one 12.5-gram-sustained-release bolus for the nearest 200 pounds § 520.2240a Sulfaethoxypyridazine so- of body weight, i.e., 62.5 milligrams per lution. pound of body weight. Do not repeat (a) Specifications. Each milliliter of treatment for 7 days. solution contains 62.5 milligrams (mg) (2) Indications for use. For the treat- sodium sulfaethoxypyridazine. ment of shipping fever complex and (b) Sponsor. See No. 054771 § 510.600(c) bacterial pneumonia associated with of this chapter. Pasteurella spp. sensitive to (c) Related tolerances. See § 556.650 of sulfadimethoxine; and calf diphtheria this chapter. and foot rot associated with (d) Conditions of use—(1) Swine—(i) Fusobacterium necrophorum sensitive to Amount. Administer 3.8 grams per gal- sulfadimethoxine. lon for first day followed by 1.9 grams (3) Limitations. Do not use in female per gallon for not less than 3 days nor dairy cattle 20 months of age or older. more than 9 days. Use as the sole Do not administer within 12 days of source of sulfonamide. slaughter. Federal law restricts this (ii) Indications for use. For treatment drug to use by or on the order of a li- of bacterial scours pneumonia enter- censed veterinarian. itis, bronchitis, septicemia accompanying Salmonella choleraesuis infec- [79 FR 28830, May 20, 2014] tion.

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(iii) Limitations. Do not treat within (ii) Indications for use. For treatment 10 days of slaughter. Federal law re- of foot rot and respiratory infections stricts this drug to use by or on the (shipping fever and pneumonia) caused order of a licensed veterinarian. by sulfonamide-susceptible pathogens (2) Cattle—(i) Amount. For use at 2.5 (E. coli, Streptococci, Staphylococci, grams per gallon. Administer at the Sphaerophorus necrophorus and Gram- rate of 1 gallon per 100 pounds of body negative rods including Pasteurella); weight per day for 4 days. Use as the and for use prophylactically during pe- sole source of sulfonamide. riods of stress for reducing losses due (ii) Indications for use. For treatment to sulfonamide sensitive disease condi- of respiratory infections (pneumonia, tions. shipping fever), foot rot, calf scours; (iii) Limitations. Do not treat within and as adjunctive therapy in septi- 16 days of slaughter. Not for use in lac- cemia accompanying mastitis and me- tating dairy cows. Federal law restricts tritis. this drug to use by or on the order of a (iii) Limitations. Do not treat within licensed veterinarian. 16 days of slaughter. Milk that has [79 FR 28830, May 20, 2014] been taken from animals during treatment and for 72 hours (6 milkings) after § 520.2260 Sulfamethazine oral dosage latest treatment must not be used for forms. food. Federal law restricts this drug to use by or on the order of a licensed vet- § 520.2260a Sulfamethazine oblet, tab- erinarian. let, and bolus. [79 FR 28830, May 20, 2014] (a)(1) Sponsor. See No. 016592 in § 510.600(c) of this chapter for use of 2.5- § 520.2240b Sulfaethoxypyridazine tab- , 5-, and 15-gram sulfamethazine oblet lets. in beef cattle, nonlactating dairy cat- (a) Specifications—(1) Each tablet con- tle, and horses. See No. 061690 in tains 2.5 or 15 grams § 510.600(c) of this chapter for use of 5- sulfaethoxypyridazine. , 15-, and 25-gram tablet in beef and (2) Each extended-release tablet con- nonlactating dairy cattle. tains 5 grams sulfaethoxypyridazine. (2) Related tolerance in edible products. (b) Sponsor. See No. 054771 § 510.600(c) See § 556.670 of this chapter. of this chapter. (3) Conditions of use—(i) Amount. Ad- (c) Related tolerances. See § 556.650 of minister as a single dose 100 milligrams this chapter. of sulfamethazine per pound of body (d) Conditions of use in cattle—(1) 2.5- weight the first day and 50 milligrams or 15-gram tablets—(i) Amount. Admin- per pound of body weight on each fol- ister 25 milligrams per pound of body lowing day. weight per day for 4 days. Use as the (ii) Indications for use. For treatment sole source of sulfonamide. of diseases caused by organisms suscep- (ii) Indications for use. For treatment tible to sulfamethazine. of respiratory infections (pneumonia, (A) Beef cattle and nonlactating dairy shipping fever), foot rot, calf scours; as cattle. Treatment of bacterial pneu- adjunctive therapy in septicemia ac- monia and bovine respiratory disease companying mastitis and metritis. complex (shipping fever complex) (iii) Limitations. Do not treat within (Pasteurella spp.), colibacillosis (bac- 16 days of slaughter. Milk that has terial scours) (Escherichia coli), necrotic been taken from animals during treat- pododermatitis (foot rot) ment and for 72 hours (6 milkings) after (Fusobacterium necrophorum), calf diph- latest treatment must not be used for theria (Fusobacterium necrophorum), food. Federal law restricts this drug to acute mastitis (Streptococcus spp.), use by or on the order of a licensed vet- acute metritis (Streptococcus spp.), coc- erinarian. cidiosis (Eimeria bovis and Eimeria (2) 15-gram extended-release tablets—(i) zurnii). Amount. Administer 100 milligrams per (B) Horses. Treatment of bacterial pound of body weight. Use as the sole pneumonia (secondary infections asso- source of sulfonamide. ciated with Pasteurella spp.), strangles

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(Streptococcus equi), and bacterial en- symptoms persist after 2 or 3 days, con- teritis (Escherichia coli). sult a veterinarian. (iii) Limitations. Administer daily [54 FR 15751, Apr. 19, 1989; 54 FR 19283, May 4, until animal’s temperature and appear- 1989, as amended at 56 FR 50653, Oct. 8, 1991; ance are normal. If symptoms persist 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, after using for 2 or 3 days consult a 1996; 64 FR 66383, Nov. 26, 1999; 67 FR 78355, veterinarian. Fluid intake must be ade- Dec. 24, 2002; 75 FR 10166, Mar. 5, 2010; 76 FR quate. Treatment should continue 24 to 17337, Mar. 29, 2011; 79 FR 28830, May 20, 2014; 81 FR 17607, Mar. 30, 2016] 48 hours beyond the remission of disease symptoms, but not to exceed 5 § 520.2260b Sulfamethazine sustained- consecutive days. Follow dosages care- release boluses. fully. Do not treat cattle within 10 (a)(1) Sponsor. See No. 000859 in days of slaughter. Do not use in female § 510.600(c) of this chapter for use of a dairy cattle 20 months of age or older. 22.5-gram sulfamethazine prolonged-re- Use of sulfamethazine in this class of lease bolus. cattle may cause milk residues. A (2) Conditions of use—(i) Amount. De- withdrawal period has not been estab- pending on the duration of therapeutic lished in preruminating calves. Do not levels desired, administer boluses as a use in calves to be processed for veal. single dose as follows: 31⁄2 days—1 bolus Do not use in horses intended for (22.5 grams) per 200 pounds of body human consumption. weight; 5 days—1 bolus per 100 pounds (b)(1) Sponsor. See No. 054771 in of body weight. § 510.600(c) of this chapter for use of 5- (ii) Indications for use. Beef and non- gram sulfamethazine bolus. lactating cattle for sustained treat- (2) Related tolerances in edible prod- ment of shipping fever pneumonia ucts. See § 556.670 of this chapter. caused or complicated by Pasteurella (3) Conditions of use—(i) Amount. Ad- multocida; as an aid in the treatment of foot rot, mastitis, pneumonia, metritis, minister 10 grams (2 boluses) of bacterial enteritis, calf diphtheria, and sulfamethazine per 100 pounds of body septicemia when caused or complicated weight the first day, then 5 grams (1 by bacteria susceptible to bolus) of sulfamethazine per 100 pounds sulfamethazine. of body weight daily for up to 4 addi- (iii) Limitations. Cattle that are tional consecutive days. acutely ill should be treated (ii) Indications for use. Ruminating parenterally with a suitable anti- beef and dairy calves. For treatment of bacterial product to obtain immediate the following diseases caused by orga- therapeutic blood levels; do not slaugh- nisms susceptible to sulfamethazine: ter animals for food within 16 days of bacterial scours (colibacilloosis) caused treatment; do not use in lactating by E. coli; necrotic pododermatitis (foot dairy cattle; Federal law restricts this rot) and calf diphtheria caused by F. drug to use by or on the order of a li- necrophorum; bacterial pneumonia asso- censed veterinarian. ciated with Pasteurella spp.; and coc- (b)(1) Sponsor. See No. 054771 in cidiosis caused by E. bovis and E. zurnii. § 510.600(c) of this chapter for use of a (iii) Limitations. Do not administer 27-gram sulfamethazine sustained-re- for more than 5 consecutive days. Do lease bolus. not treat calves within 11 days of (2) Conditions of use—(i) Amount. 27 slaughter. Do not use in calves to be grams (1 bolus) for each 150 pounds of slaughtered under 1 month of age or in body weight as a single dose. calves being fed an all milk diet. Do (ii) Indications for use. For nonlactating cattle for the treatment of in- not use in female dairy cattle 20 fections caused by organisms sensitive months of age or older; such use may to sulfamethazine such as hemorrhagic cause drug residues in milk. Admin- septicemia (shipping fever complex), ister with adequate supervision. Fol- bacterial pneumonia, foot rot, and calf lows recomended dosages carefully. diphtheria and as an aid in the control Fluid intake must be adequate. If of bacterial diseases usually associated with shipping and handling of cattle.

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(iii) Limitations. If no response within treatment of the following diseases 2 to 3 days, reevaluate therapy; do not when caused by one or more of the list- crush tablets; treated animals must ed pathogenic organisms sensitive to not be slaughtered for food within 28 sulfamethazine: bovine respiratory dis- days after the latest treatment; Fed- ease complex (shipping fever complex) eral law restricts this drug to use by or (Pasteurella spp.), bacterial pneumonia on the order of a licensed veterinarian. (Pasteurella spp.), necrotic (c)(1) Sponsor. See No. 061623 in pododermatitis (foot rot) § 510.600(c) of this chapter for use of a (Fusobacterium necrophorum), 32.1-gram sustained-release bolus. colibacillosis (bacterial scours) (2) Conditions of use—(i) Amount. 32.1 (Escherichia coli), calf diphtheria grams (1 bolus) per 200 pounds of body (Fusobacterium necrophorum), acute weight. mastitis (Streptococcus spp.) and acute (ii) Indications for use. For beef and metritis (Streptococcus spp.). nonlactating dairy cattle for the treat- (iii) Limitations. Cattle that are ment of diseases caused by acutely ill should be treated by injec- sulfamethazine-sensitive organisms as tion with a suitable antibacterial prod- follows: bacterial pneumonia and bo- uct to obtain immediate therapeutic vine respiratory disease complex (ship- blood levels; do not slaughter animals ping fever complex) caused by for food within 16 days of treatment; do Pasteurella spp., colibacillosis (bac- not use in lactating dairy cattle; if terial scours) caused by E. coli, necrotic treated animals do not respond within pododermatitis (foot rot) and calf diph- 2 to 3 days, consult a veterinarian. theria caused by Fusobacterium (e)(1) Sponsor. See No. 061623 in necrophorum, and acute mastitis and § 510.600(c) of this chapter for use of an acute metritis caused by Streptococcus 8.02-gram sulfamethazine sustained-re- spp.) lease bolus. (iii) Limitations. After 72 hours, all (2) Conditions of use—(i) Amount. Ad- animals should be reexamined for per- minister 2 boluses (8.02 grams per sistence of observable disease signs. If signs are present, consult a veteri- bolus) per 100 pounds of body weight, as narian. It is strongly recommended a single dose. that a second dose be given to provide (ii) Indications for use. Administer for an additional 72 hours of therapy, orally to ruminating calves for the pro- particularly in more severe cases. The longed treatment of the following dis- dosage schedule should be used at each eases when caused by one or more of 72-hour interval. Animals should not the listed pathogenic organisms sen- receive more than 2 doses because of sitive to sulfamethazine: bacterial the possibility of incurring residue vio- pneumonia (Pasteurella spp.), lations. This drug, like all colibacillosis (bacterial scours) (E. sulfonamides, may cause toxic reac- coli), and calf diptheria (Fusobacterium tions and irreparable injury unless ad- necrophorum). ministered with adequate and contin- (iii) Limitations. For use in rumi- uous supervision; follow dosages care- nating replacement calves only; 72 fully. Fluid intake must be adequate at hours after dosing all animals should all times throughout the 3-day ther- be reexamined for persistence of dis- apy, Do not use in female dairy cattle ease signs; if signs are present, consult 20 months of age or older. Use of a veterinarian; do not slaughter ani- sulfamethazine in this class of cattle mals for food for at least 12 days after may cause milk residues. Do not treat the last dose; this product has not been animals within 12 days of slaughter. shown to be effective for nonrumi- (d)(1) Sponsor. See 000859 in § 510.600(c) nating calves; exceeding two consecu- of this chapter for use of a 22.5-gram tive doses may cause violative tissue sulfamethazine sustained release bolus. residue to remain beyond the with- (2) Conditions of use—(i) Amount. Ad- drawal time; do not use in calves under minister 1 bolus (22.5 grams) per 200 1 month of age or calves being fed an pounds of body weight, as a single dose. all milk diet. (ii) Indications for use. Beef and non- (f)(1) Sponsor. See No. 016592 in lactating dairy cattle for the prolonged § 510.600(c) of this chapter for use of a

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30-gram sulfamethazine sustained-re- or calves being fed an all milk diet. Do lease bolus. not use in female dairy cattle 20 (2) Conditions of use—(i) Amount. Ad- months of age or older. If symptoms minister at the rate of 1 bolus (30 persist after 3 days, consult a veteri- grams per bolus) per 200 pounds of body narian. Do not administer more than 2 weight, as a single dose. consecutive doses. Do not slaughter (ii) Indications for use. Administer animals for food for at least 8 days orally to beef cattle and nonlactating after the last dose. Do not crush bolus. dairy cattle for the treatment of the [46 FR 36132, July 14, 1981, as amended at 48 following diseases when caused by one FR 18803, Apr. 26, 1983; 48 FR 32760, July 19, or more of the listed pathogenic orga- 1983; 49 FR 29057, July 18, 1984; 50 FR 49372, nisms sensitive to sulfamethazine: bo- Dec. 2, 1985; 51 FR 30212, Aug. 25, 1986; 53 FR vine respiratory disease complex (ship- 40727, Oct. 18, 1988; 54 FR 14341, Apr. 11, 1989; ping fever complex) associated with 55 FR 8462, Mar. 8, 1990; 56 FR 50653, Oct. 8, Pasteurella spp.; bacterial pneumonia 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. associated with Pasteurell spp.; necrotic 9, 1996; 62 FR 35076, June 30, 1997; 66 FR 14073, pododermatitis (foot rot) and calf diph- Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 70 FR 8290, Feb. 18, 2005; 78 FR 17596, Mar. 22, 2013; theria caused by Fusobacterium 79 FR 28830, May 20, 2014; 81 FR 22523, Apr. 18, necrophorum; colibacillosis (bacterial 2016] scours) caused by Escherichia coli; coccidiosis caused by Eimeria bovis and E. § 520.2260c Sulfamethazine sustained- zurnii; acute mastitis and metritis release tablets. caused by Streptococcus spp. (a) Specifications. Each extended-re- (iii) Limitations. For use in beef cattle lease tablet contains 8 grams and nonlactating dairy cattle only; if sulfamethazine. symptoms persist for 2 or 3 days after (b) Sponsor. See No. 054771 in use, consult a veterinarian; do not § 510.600(c) of this chapter. slaughter animals for food for at least (c) Related tolerances. See § 556.670 of 8 days after the last dose; do not use in this chapter. lactating dairy cattle; do not admin- (d) Conditions of use—(1) Amount. 8 ister more than two consecutive doses. grams (1 tablet) per 45 pounds of body (g) Related tolerances. See § 556.670 of weight as a single dose. this chapter. (2) Indications for use. In calves for (h)(1) Sponsor. See No. 000010 in sustained treatment of pneumonia § 510.600(c) of this chapter for use of an caused by Pasteurella spp., 8.25-gram sulfamethazine sustained-re- colibacillosis (bacterial scours) caused lease bolus. by Escherichia coli; and calf diptheria (2) Conditions of use—(i) Amount. Ad- caused by Fusobacterium necrophorum. minister at the rate of 1 bolus (8.25 (3) Limitations. Treated animals must grams per bolus) per 50 pounds of body not be slaughtered for food within 18 weight, as a single dose. If signs of dis- days after the latest treatment. Fed- ease are significantly reduced, it is rec- eral law restricts this drug to use by or ommended that a second dose be given on the order of a licensed veterinarian. to provide an additional 72 hours of therapy. [48 FR 26763, June 10, 1983, as amended at 56 FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; (ii) Indications for use. Administer 61 FR 4875, Feb. 9, 1996; 79 FR 28830, May 20, orally to ruminating beef and dairy 2014] calves for treatment of the following diseases when caused by one or more of § 520.2261 Sulfamethazine sodium oral the listed pathogenic organisms sus- dosage forms. ceptible to sulfamethazine: bacterial pneumonia associated with Pasteurella § 520.2261a Sulfamethazine solution. spp.; colibacillosis (bacterial scours) (a) Specifications. Each milliliter of caused by Escherichia coli; coccidiosis solution contains 125 milligrams (12.5 caused by Eimeria bovis and E. zurnii; percent) sulfamethazine sodium. and calf diphtheria caused by (b) Sponsors. See No. 016592 in Fusobacterium necrophorum. § 510.600(c) of this chapter. (iii) Limitations. Do not use in calves (c) Related tolerances. See § 556.670 of to be slaughtered under 1 month of age this chapter.

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(d) Conditions of use—(1) Amount. Ad- medication from swine 15 days before minister in drinking water to provide: slaughter for food. Do not medicate Cattle and swine 112.5 milligrams of chickens or turkeys producing eggs for sulfamethazine sodium per pound of human consumption. Treatment of all body weight per day on the first day diseases should be instituted early. and 56.25 milligrams per pound of body Treatment should continue 24 to 48 weight on subsequent days; Chickens, hours beyond the remission of disease 61 to 89 milligrams of sulfamethazine symptoms, but not to exceed a total of sodium per pound of body weight per 5 consecutive days in cattle or swine. day, and turkeys 53 to 130 milligrams Medicated cattle, swine, chickens, and of sulfamethazine sodium per pound of turkeys must actually consume enough body weight per day, depending upon medicated water which provides the the dosage, age, and class of chickens recommended dosages. Do not use in fe- or turkeys, ambient temperature, and male dairy cattle 20 months of age or other factors. older. Use of sulfamethazine in this (2) Indications for use. For treatment class of cattle may cause milk resi- and control of diseases caused by orga- dues. A withdrawal period has not been nisms sensitive to sulfamethazine. established in preruminating calves. (i) Beef and nonlactating dairy cattle. Do not use in calves to be processed for Treatment of bacterial pneumonia and veal. Federal law restricts this drug to bovine respiratory disease complex use by or on the order of a licensed vet- (shipping fever complex) (Pasteurella erinarian. spp.), colibacillosis (bacterial scours) [47 FR 25322, June 11, 1982, as amended at 47 (Escherichia coli), necrotic FR 25735, June 15, 1982; 67 FR 78355, Dec. 24, pododermatitis (foot rot) 2002; 70 FR 32489, June 3, 2005; 74 FR 36112, (Fusobacterium necrophorum), calf diph- July 22, 2009; 75 FR 10166, Mar. 5, 2010; 76 FR theria (Fusobacterium necrophorum), 17337, Mar. 29, 2011; 79 FR 28831, May 20, 2014; acute mastitis (Streptococcus spp.), and 81 FR 17607, Mar. 30, 2016; 81 FR 36789, June acute metritis (Streptococcus spp.). 8, 2016; 81 FR 94990, Dec. 27, 2016] (ii) Swine. Treatment of porcine colibacillosis (bacterial scours) § 520.2261b Sulfamethazine powder. (Escherichia coli), and bacterial pneu- (a) Specifications. A soluble powder monia (Pasteurella spp.). composed of 100 percent sulfamethazine (iii) Chickens and turkeys. In chickens sodium. for control of infectious coryza (b) Sponsors. See Nos. 016592 and (Avibacterium paragallinarum), coccidi- 061623 in § 510.600(c) of this chapter. osis (Eimeria tenella, Eimeria necatrix), (c) Related tolerances. See § 556.670 of acute fowl cholera (Pasteurella this chapter. multocida), and pullorum disease (d) Conditions of use—(1) Chickens—(i) (Salmonella Pullorum). In turkeys for Amount. Administer in drinking water control of coccidiosis (Eimeria to provide 58 to 85 milligrams (mg) per meleagrimitis, Eimeria adenoeides). Medi- pound (/lb) of body weight per day. cate as follows: Infectious coryza in (ii) Indications for use. For control of chickens, medicate for 2 consecutive infectious coryza (Avibacterium days; acute fowl cholera and pullorum paragallinarum), coccidiosis (Eimeria disease, in chickens, medicate for 6 tenella, E. necatrix), acute fowl cholera consecutive days; coccidiosis, in chick- (Pasteurella multocida), and pullorum ens and turkeys, medicate as in para- disease (Salmonella Pullorum). graph (c) of this section, then reduce (iii) Limitations. Add the required amount of medication to one-half for 4 dose to that amount of water that will additional days. be consumed in 1 day. Consumption (3) Limitations. Add the required dose should be carefully checked. Have only to that amount of water that will be medicated water available during consumed in 1 day. Consumption treatment. Withdraw medication 10 should be carefully checked. Have only days prior to slaughter for food. Do not medicated water available during medicate chickens producing eggs for treatment. Withdraw medication from human consumption. Treatment of all cattle, chickens, and turkeys 10 days diseases should be instituted early. prior to slaughter for food. Withdraw Treatment should continue 24 to 48

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hours beyond the remission of disease (4) Cattle—(i) Amount. Administer in symptoms. Medicated chickens must drinking water, or as a drench, to pro- actually consume enough medicated vide 108 mg/lb of body weight on the water which provides the recommended first day and 54 mg/lb of body weight dosages. Federal law restricts this drug per day on the second, third, and fourth to use by or on the order of a licensed days of administration. veterinarian. (ii) Indications for use in beef and non- (2) Turkeys—(i) Amount. Administer lactating dairy cattle. Treatment of bac- in drinking water to provide 50 to 124 terial pneumonia and bovine res- mg/lb of body weight per day piratory disease complex (shipping (ii) Indications for use. For control of fever complex) (Pasteurella spp.), coccidiosis (E. meleagrimitis, E. colibacillosis (bacterial scours) (E. adenoeides). coli), necrotic pododermatitis (foot rot) (iii) Limitations. Add the required (Fusobacterium necrophorum), calf diph- dose to that amount of water that will theria (F. necrophorum), acute mastitis be consumed in 1 day. Consumption (Streptococcus spp.), and acute metritis should be carefully checked. Have only (Streptococcus spp.) medicated water available during (iii) Limitations. Add the required treatment. Withdraw medication 10 dose to that amount of water that will days prior to slaughter for food. Do not be consumed in 1 day. Consumption medicate turkeys producing eggs for should be carefully checked. Have only human consumption. Treatment of all medicated water available during diseases should be instituted early. treatment. Withdraw medication 10 Treatment should continue 24 to 48 days prior to slaughter for food. Treat- hours beyond the remission of disease ment of all diseases should be insti- symptoms. Medicated turkeys must ac- tuted early. Treatment should con- tually consume enough medicated tinue 24 to 48 hours beyond the remis- water which provides the recommended sion of disease symptoms, but not to dosages. Federal law restricts this drug exceed a total of 5 consecutive days. to use by or on the order of a licensed Medicated cattle must actually con- veterinarian. sume enough medicated water which (3) Swine—(i) Amount. Administer in provides the recommended dosages. Do drinking water, or as a drench, to pro- not use in female dairy cattle 20 vide 108 mg/lb of body weight on the months of age or older. Use of first day and 54 mg/lb of body weight sulfamethazine in this class of cattle per day on the second, third, and fourth may cause milk residues. Do not use in days of administration. calves under one (1) month of age or (ii) Indications for use. For treatment calves being fed an all-milk diet. Use in of porcine colibacillosis (bacterial these classes of calves may cause viola- scours) (E. coli), and bacterial pneu- tive residues to remain beyond the monia (Pasteurella spp.). withdrawal time. Federal law restricts (iii) Limitations. Add the required this drug to use by or on the order of a dose to that amount of water that will licensed veterinarian. be consumed in 1 day. Consumption [71 FR 70303, Dec. 4, 2006, as amended at 75 should be carefully checked. Have only FR 10166, Mar. 5, 2010; 79 FR 28831, May 20, medicated water available during 2014; 80 FR 61296, Oct. 13, 2015; 81 FR 17607, treatment. Withdraw medication 15 Mar. 30, 2016; 81 FR 94990, Dec. 27, 2016] days prior to slaughter for food. Treat- ment of all diseases should be insti- § 520.2280 Sulfamethizole and methe- tuted early. Treatment should con- namine. tinue 24 to 48 hours beyond the remis- (a) Specifications. Each tablet con- sion of disease symptoms, but not to tains 250 milligrams of sulfamethizole exceed a total of 5 consecutive days. and 250 milligrams of methenamine Medicated swine must actually con- mandelate. sume enough medicated water which (b) Sponsor. See No. 054771 in provides the recommended dosages. § 510.600(c) of this chapter. Federal law restricts this drug to use (c) Conditions of use in dogs and cats— by or on the order of a licensed veteri- (1) Amount. Administer orally 1 tablet narian. per 20 pounds of body weight 3 times

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per day until clinical signs are allevi- change litter unless absolutely nec- ated. To reduce the possibility of re- essary. Do not give flushing mashes. lapse, continue therapy for a week to (2) Turkeys. (i) As an aid in the con- 10 days. trol of outbreaks of coccidiosis caused (2) Indications for use. For treatment by Eimeria meleagrimitis and E. of urinary tract infections such as cys- adenoeides. titis, nephritis, prostatitis, urethritis, (ii) Administer at the 0.025 percent and pyelonephritis. As an aid in the level for 2 days, skip 3 days, give for 2 management of complications result- days, skip 3 days and give for 2 more ing from surgical manipulations of the days. Repeat if necessary. Do not urinary tract such as removal of change litter unless absolutely nec- calculi from the bladder, in essary. Do not give flushing mashes. ureterostomies, and in instrumenta- (3) Chickens and turkeys. (i) As an aid tion of the urethra and bladder. in the control of acute fowl cholera (3) Limitations. Federal law restricts caused by Pasteurella multocida suscep- this drug to use by or on the order of a tible to sulfaquinoxaline and fowl ty- licensed veterinarian. phoid caused by Salmonella gallinarum susceptible to sulfaquinoxaline. [40 FR 13838, Mar. 27, 1975, as amended at 50 (ii) Administer at the 0.04 percent FR 13561, Apr. 5, 1985; 79 FR 28831, May 20, level for 2 or 3 days. Move birds to 2014] clean ground. If disease recurs, repeat § 520.2325 Sulfaquinoxaline oral dos- treatment. If cholera has become es- age forms. tablished as the respiratory or chronic form, use feed medicated with § 520.2325a Sulfaquinoxaline powder sulfaquinoxaline. Poultry which have and solution. survived typhoid outbreaks should not (a) Sponsor. See § 510.600(c) of this be kept for laying house replacements chapter for identification of the spon- or breeders unless tests show they are sors. not carriers. (4) Cattle and calves. (i) For the con- (1) To No. 016592 for use of a 25-per- trol and treatment of outbreaks of coc- cent sulfaquinoxaline soluble powder cidiosis caused by Eimeria bovis or E. and a 20-percent sulfaquinoxaline so- zurnii. dium solution as provided for in para- (ii) Administer at the 0.015-percent graph (c) of this section. level for 3 to 5 days in drinking water (2) To Nos. 016592 and 054771 for use of medicated with sulfaquinoxaline solu- a 31.92-percent sulfaquinoxaline solution. tion (sodium and potassium salts) as (iii) In lieu of treatment as provided provided for in paragraphs (c)(1), (c)(2), in paragraph (e)(4)(ii) of this section, (c)(3), (c)(4)(i), and (c)(4)(ii) of this sec- administer 1 teaspoon of 25-percent tion. sulfaquinoxaline soluble powder per (3) No. 054771 for use of a 28.62-percent day for each 125 pounds of body weight sulfaquinoxaline sodium solution as for 3 to 5 days in drinking water. provided in paragraphs (c)(1), (c)(2), and (d) Limitations. May cause toxic reac- (c)(3) of this section. tions unless the drug is evenly mixed (b) Related tolerances. See § 556.685 of in water at dosages indicated and used this chapter. according to directions. For control of (c) Conditions of use. It is used in outbreaks of disease, medication drinking water as follows: should be initiated as soon as the diag- (1) Chickens. (i) As an aid in the con- nosis is determined. Medicated chick- trol of outbreaks of coccidiosis caused ens, turkeys, cattle, and calves must by Eimeria tenella, E. necatrix, E. actually consume enough medicated acervulina, E. maxima, and E. brunetti. water which provides a recommended (ii) Administer at the 0.04 percent dosage of approximately 10 to 45 milli- level for 2 or 3 days, skip 3 days then grams per pound per day in chickens, administer at the 0.025 percent level for 3.5 to 55 milligrams per pound per day 2 more days. If bloody droppings ap- in turkeys, and approximately 6 milli- pear, repeat treatment at the 0.025 per- grams per pound per day in cattle and cent level for 2 more days. Do not calves depending on the age, class of

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animal, ambient temperature, and when caused by organisms sensitive to other factors. A withdrawal period has sulfisoxazole. not been established for (3) Limitations. Repeat dosage at 24- sulfaquinoxaline in preruminating hour intervals until 2 to 3 days after calves. Do not use in calves to be proc- disappearance of clinical symptoms. essed for veal. Not for use in lactating (Administration of one-half daily dos- dairy cattle. Do not give to chickens, age at 12-hour intervals or one-third turkeys or cattle within 10 days of daily dosage at 8-hour intervals will slaughter for food. Do not medicate provide a more constant blood level.) chickens or turkeys producing eggs for Provide adequate supply of drinking human consumption. Make fresh drink- water. If symptoms persist after using ing water daily. Federal law restricts this preparation for 2 or 3 days, consult this drug to use by or on the order of a a veterinarian. licensed veterinarian. [43 FR 60895, Dec. 29, 1978, as amended at 79 [48 FR 3964, Jan. 28, 1983, as amended at 48 FR 28831, May 20, 2014] FR 26762, June 10, 1983; 55 FR 29843, July 23, 1990; 59 FR 28769, June 3, 1994; 59 FR 33197, § 520.2340 Tepoxalin. June 28, 1994; 61 FR 24443, May 15, 1996; 61 FR (a) Specifications. Each tablet con- 63711, Dec. 2, 1996; 62 FR 37712, July 15, 1997; tains 30, 50, 100, or 200 milligrams (mg) 65 FR 10705, Feb. 29, 2000; 69 FR 41427, July 9, tepoxalin. 2004; 69 FR 60547, Oct. 12, 2004; 74 FR 36112, July 22, 2009; 78 FR 17596, Mar. 22, 2013; 79 FR (b) Sponsor. See No. 000061 in 28831, May 20, 2014; 81 FR 22523, Apr. 18, 2016; § 510.600(c) of this chapter. 81 FR 36789, June 8, 2016; 81 FR 59134, Aug. 29, (c) Conditions of use in dogs—(1) 2016; 81 FR 94990, Dec. 27, 2016] Amount. 10 mg per kilogram (/kg) daily; or 20 mg/kg on the initial day of treat- § 520.2325b Sulfaquinoxaline drench. ment, followed by 10 mg/kg daily. (a) Specifications. A soluble powder (2) Indications for use. For the control containing 25 percent sulfaquinoxaline. of pain and inflammation associated (b) Sponsor. See No. 016592 in with osteoarthritis. § 510.600(c) of this chapter. (3) Limitations. Federal law restricts this drug to use by or on the order of a (c) Conditions of use in cattle—(1) licensed veterinarian. Amount. Administer 1 teaspoon of 25 percent sulfaquinoxaline soluble pow- [68 FR 34795, June 11, 2003] der for each 125 pounds of body weight for 3 to 5 days as a drench. § 520.2345 Tetracycline. (2) Indications for use. For the control § 520.2345a Tetracycline capsules. and treatment of outbreaks of coccidiosis in cattle and calves caused by (a) Specifications. Each capsule con- Eimeria bovis or E. zuernii. tains 50, 100, 125, 250, or 500 milligrams (3) Limitations. Do not give to cattle (mg) tetracycline hydrochloride. within 10 days of slaughter for food. (b) Sponsor. See No. 054771 in Not for use in lactating dairy cattle. § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) [79 FR 28831, May 20, 2014, as amended at 82 Amount. 25 mg per pound of body FR 12169, Mar. 1, 2017] weight per day in divided doses every 6 hours. § 520.2330 Sulfisoxazole tablets. (2) Indications for use. For treatment (a) Specifications. Each tablet con- of infections caused by organisms sen- tains 260 milligrams (4 grains) of sitive to tetracycline hydrochloride, sulfisoxazole. such as bacterial gastroenteritis due to (b) Sponsor. See No. 054771 in E. coli and urinary tract infections due § 510.600(c) of this chapter. to Staphylococcus spp. and E. coli. (c) Conditions of use—(1) Amount. Ad- (3) Limitations. Federal law restricts minister one tablet orally per 4 pounds this drug to use by or on the order of a of body weight. licensed veterinarian. (2) Indications for use. Use in dogs and [70 FR 50182, Aug. 26, 2005, as amended at 73 cats as an aid in treatment of bacterial FR 18442, Apr. 4, 2008; 79 FR 28831, May 20, pneumonia and bacterial enteritis 2014]

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§ 520.2345b Tetracycline tablets. animals for food within 12 days of treatment; use as sole source of tetra- (a) Specifications. Each tablet con- cycline. tains 100, 250, or 500 milligrams of tetracycline (as the hydrochloride). [57 FR 37328, Aug. 18, 1992, as amended at 67 (b) Sponsor. See No. 054771 in FR 78355, Dec. 24, 2002; 79 FR 28831, May 20, § 510.600(c) of this chapter. 2014; 81 FR 67151, Sept. 30, 2016] (c) Conditions of use. Dogs—(1) Amount. 25 milligrams per pound of § 520.2345d Tetracycline powder. body weight per day in divided doses (a) Specifications. Each pound of pow- every 6 hours. der contains 25, 102.4, or 324 grams tet- (2) Indications for use. Treatment of racycline hydrochloride. infections caused by organisms sen- (b) Sponsors. See sponsors listed in sitive to tetracycline hydrochloride, § 510.600(c) of this chapter for condi- such as bacterial gastroenteritis due to tions of use as in paragraph (d) of this E. coli and urinary tract infections due section: to Staphylococcus spp. and E. coli. (1) No. 054771: 25 grams per pound as (3) Limitations. Administer orally; in paragraphs (d)(3) and (d)(4) of this continue treatment until symptoms of section. the disease have subsided and tempera- (2) No. 066104: 25, 102.4, and 324 grams ture is normal for 48 hours; not for use per pound as in paragraph (d) of this in animals raised for food production; section. Federal law restricts this drug to use (3) Nos. 016592 and 054771: 25, 102.4, and by or on the order of a licensed veteri- 324 grams per pound as in paragraph (d) narian. of this section. [57 FR 37327, Aug. 18, 1992, as amended at 79 (4) Nos. 054925, 057561, 061623, and FR 28831, May 20, 2014] 076475: 324 grams per pound as in paragraph (d) of this section. § 520.2345c Tetracycline boluses. (5) No. 016592: 25 grams per pound as (a) Specifications. Each bolus contains in paragraphs (d)(1) and (d)(2) of this 500 milligrams of tetracycline (as the section. hydrochloride). (c) Related tolerances. See § 556.720 of (b) Sponsor. See No. 054771 in this chapter. § 510.600(c) of this chapter. (d) Conditions of use. It is adminis- (c) Related tolerances. See § 556.720 of tered in drinking water as follows: this chapter. (1) Calves—(i) Amount. 10 milligrams (d) Conditions of use. Calves—(1) per pound of body weight per day in di- Amount. 10 milligrams per pound of vided doses. body weight per day in divided doses. (ii) Indications for use. Control and (i) Indications for use. Control and treatment of bacterial enteritis treatment of bacterial enteritis (scours) caused by Escherichia coli and (scours) caused by E. coli and bacterial bacterial pneumonia (shipping fever pneumonia caused by Pasteurella spp., complex) associated with Pasteurella Hemophilus spp., and Klebsiella spp. spp., Actinobacillus pleuropneumoniae (ii) Limitations. Administer orally for (Haemophilus spp.), and Klebsiella spp., 3 to 5 days; do not slaughter animals susceptible to tetracycline. for food within 14 days of treatment; (iii) Limitations. Administer for 3 to 5 use as sole source of tetracycline. days; do not slaughter animals for food (2) Amount. 10 milligrams per pound within 4 days of treatment for No. of body weight per day in two divided 066104 and within 5 days of treatment doses. for Nos. 016592, 054771, 054925, 057561, (i) Indications for use. Treatment of 059130, and 061623; prepare a fresh solu- bacterial pneumonia caused by orga- tion daily; use as the sole source of tet- nisms susceptible to tetracycline, bac- racycline. A withdrawal period has not terial enteritis caused by E. coli, and been established for this product in salmonella organisms susceptible to preruminating calves. Do not use in tetracycline. calves to be processed for veal. Federal (ii) Limitations. Administer orally for law restricts this drug to use by or on not more than 5 days; do not slaughter the order of a licensed veterinarian.

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(2) Swine—(i) Amount. 10 milligrams to use by or on the order of a licensed per pound of body weight per day in di- veterinarian. vided doses. [59 FR 17693, Apr. 14, 1994, as amended at 59 (ii) Indications for use. Control and FR 19133, Apr. 22, 1994; 62 FR 5319, Feb. 5, treatment of bacterial enteritis 1997; 62 FR 35076, June 30, 1997; 62 FR 46668, (scours) caused by E. coli and bacterial Sept. 4, 1997; 62 FR 55160, Oct. 23, 1997; 64 FR pneumonia associated with Pasteurella 37673, July 13, 1999; 67 FR 78355, Dec. 24, 2002; spp., A. pleuropneumoniae (Haemophilus 70 FR 16934, Apr. 4, 2005; 70 FR 67353, Nov. 7, spp.), and Klebsiella spp., susceptible to 2005; 71 FR 13542, Mar. 16, 2006; 75 FR 10166, tetracycline. Mar. 5, 2010; 75 FR 12981, Mar. 18, 2010; 76 FR 17338, Mar. 29, 2011; 77 FR 20988, Apr. 9, 2012; (iii) Limitations. Administer for 3 to 5 78 FR 21060, Apr. 9, 2013; 79 FR 28831, May 20, days; do not slaughter animals for food 2014; 81 FR 17607, Mar. 30, 2016; 81 FR 22523, within 7 days of treatment for No. Apr. 18, 2016; 81 FR 94990, Dec. 27, 2016] 066104 and within 4 days of treatment for Nos. 016592, 054771, 054925, 057561, § 520.2345e Tetracycline solution. 059130, and 061623; prepare a fresh solu- (a) Specifications. Each milliliter con- tion daily; use as the sole source of tet- tains the equivalent of either 25 or 100 racycline. Federal law restricts this milligrams of tetracycline hydro- drug to use by or on the order of a li- chloride. censed veterinarian. (b) Sponsor. See No. 054771 in (3) Chickens—(i) Amount. Chronic res- § 510.600(c) of this chapter. piratory disease: 400 to 800 milligrams (c) Conditions of use—(1) Dogs—(i) per gallon. Infectious synovitis: 200 to Amount. 25 milligrams per pound of 400 milligrams per gallon. body weight per day in divided doses (ii) Indications for use. Control of every 6 hours. chronic respiratory disease (CRD or (ii) Indications for use. Treatment of air-sac disease) caused by Mycoplasma infections caused by organisms sen- gallisepticum and E. coli; control of in- sitive to tetracycline hydrochloride, fectious synovitis caused by M. such as bacterial gastroenteritis due to synoviae susceptible to tetracycline. Escherichia coli and urinary tract infec- (iii) Limitations. Administer for 7 to tions due to Staphylococcus spp. and E. 14 days; do not slaughter for food with- coli. in 4 days of treatment; not for use in (iii) Limitations. Administer orally; chickens producing eggs for human continue treatment until symptoms consumption; prepare a fresh solution have subsided and the temperature is daily; use as the sole source of tetra- normal for 48 hours; not for use in ani- cycline. Federal law restricts this drug mals which are raised for food produc- to use by or on the order of a licensed tion; Federal law restricts this drug to veterinarian. use by or on the order of a licensed vet- (4) Turkeys—(i) Amount. For infec- erinarian. tious synovitis: 400 milligrams per gallon. For complicating bacterial orga- (2) Dogs and cats—(i) Amount. 25 milli- nisms associated with bluecomb (trans- grams per pound of body weight per missible enteritis or coronaviral enter- day in divided doses every 6 hours. itis): 25 milligrams per pound of body (ii) Indications for use. Treatment of weight per day. infections caused by organisms suscep- (ii) Indications for use. Control of in- tible to tetracycline hydrochloride, fectious synovitis caused by M. such as bacterial gastroenteritis due to synoviae; control of bluecomb com- E. coli and urinary tract infections due plicated by organisms sensitive to tet- to Staphylococcus spp. and E. coli. racycline. (iii) Limitations. Administer orally; (iii) Limitations. Administer for 7 to continue treatment until the tempera- 14 days; do not slaughter for food with- ture has been normal for 48 hours; not in 4 days of treatment; not for use in for use in food-producing animals; Fed- turkeys producing eggs for human con- eral law restricts this drug to use by or sumption; prepare a fresh solution on the order of a licensed veterinarian. daily; use as the sole source of tetra- [57 FR 37329, Aug. 18, 1992, as amended at 79 cycline. Federal law restricts this drug FR 28831, May 20, 2014]

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§ 520.2345f Tetracycline phosphate § 520.2345h Tetracycline hydro- complex and sodium novobiocin chloride, sodium novobiocin, and capsules. prednisolone tablets. (a) Specifications. Each capsule con- (a) Specifications. Each tablet contains the equivalent of 60 milligrams of tains the equivalent of 60 milligrams of tetracycline hydrochloride and 60 mil- tetracycline hydrochloride, 60 milli- ligrams of novobiocin. grams of novobiocin, and 1.5 milli- (b) Sponsor. No. 054771 in § 510.600(c) of grams of prednisolone or 180 milli- this chapter. grams of tetracycline hydrochloride, (c) Conditions of use in dogs—(1) 180 milligrams of novobiocin, and 4.5 Amount. 10 milligrams of each anti- milligrams of prednisolone. biotic per pound of body weight (1 cap- (b) Sponsor. See No. 054771 in sule for each 6 pounds) every 12 hours. § 510.600(c) of this chapter. (2) Indications for use. Treatment of (c) Conditions of use in dogs—(1) acute or chronic canine respiratory in- Amount. 10 milligrams of each anti- fections such as tonsillitis, bronchitis, biotic and 0.25 milligram of prednisolone per pound of body weight (one and tracheobronchitis when caused by single-strength tablet for each 6 pounds pathogens susceptible to tetracycline or one triple-strength tablet for each 18 and/or novobiocin, such as Staphy- pounds) every 12 hours for 48 hours. lococcus spp. and Escherichia coli. Treatment is to be continued with (3) Limitations. Federal law restricts novobiocin and tetracycline alone at this drug to use by or on the order of a the same dose schedule for an addi- licensed veterinarian. tional 3 days or longer as needed. [57 FR 37329, Aug. 18, 1992, as amended at 79 (2) Indications for use. Treatment of FR 28831, May 20, 2014] acute and chronic canine respiratory infections such as tonsillitis, bron- § 520.2345g Tetracycline hydrochloride chitis, and tracheobronchitis when and sodium novobiocin tablets. caused by pathogens susceptible to tet- (a) Specifications. Each tablet con- racycline and/or novobiocin, such as tains the equivalent of 60 milligrams of Staphylococcus spp. and Escherichia coli, tetracycline hydrochloride and 60 mil- when it is necessary to initially reduce ligrams of novobiocin, or 180 milli- the severity of associated clinical grams of tetracycline hydrochloride signs. and 180 milligrams of novobiocin. (3) Limitations. Federal law restricts (b) Sponsor. See No. 054771 in this drug to use by or on the order of a licensed veterinarian. § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) [57 FR 37329, Aug. 18, 1992, as amended at 79 Amount. 10 milligrams of each anti- FR 28832, May 20, 2014] biotic per pound of body weight (one single-strength tablet for each 6 pounds § 520.2362 Thenium closylate. or one triple-strength tablet for each 18 (a) Specifications. Each tablet con- pounds). tains thenium closylate equivalent to (2) Indications for use. Treatment of 500 milligrams thenium base. acute or chronic canine respiratory in- (a) Specifications. Thenium closylate fections such as tonsillitis, bronchitis, tablets contain thenium closylate and tracheobronchitis when caused by equivalent to 500 milligrams thenium pathogens susceptible to tetracycline as base in each tablet. and/or novobiocin, such as Staphy- (b) Sponsor. See No. 000061 in lococcus spp. and Escherichia coli. § 510.600(c) of this chapter. (3) Limitations. Federal law restricts (c) Conditions of use in dogs—(1) this drug to use by or on the order of a Amount. Dogs weighing over 10 pounds: licensed veterinarian. Administer 1 tablet as a single dose. Dogs weighing 5 to 10 pounds: Adminis- [57 FR 37329, Aug. 18, 1992, as amended at 79 tered one-half tablet twice during a FR 28831, May 20, 2014] single day. Repeat treatment after 2 or 3 weeks.

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(2) Indications for use. For treatment Poteriostomum, Oxyuris, and of canine ancylostomiasis by the re- Strongyloides. moval from the intestines of the adult (2) Limitations. Administer in a single forms of the species Ancylostoma dosage mixed with the normal grain ra- caninum and Uncinaria stenocephala tion given at one feeding. Warning: Not (hookworms). for use in horses intended for food. (3) Limitations. Federal law restricts (b) Amount. 4 grams per 100 pounds of this drug to use by or on the order of a body weight. licensed veterinarian. (1) Indications for use. For control of [40 FR 13838, Mar. 27, 1975, as amended at 41 ascarids of the genus Parascaris. FR 53477, Dec. 7, 1976; 46 FR 48642, Oct. 2, 1981; (2) Limitations. Administer in a single 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, dosage mixed with the normal grain ra- 1997; 79 FR 28832, May 20, 2014] tion given at one feeding. Warning: Not for use in horses intended for food. § 520.2380 Thiabendazole oral dosage forms. (2) Cattle—(i) Route of administration. In feed block. § 520.2380a Thiabendazole top dress- (ii) Amount. 3.3 percent block con- ing and mineral protein block. sumed at the recommended level of 0.11 (a) Specifications. Conforms to N.F. pound per 100 pounds of body weight XII. per day. (b) Sponsors. See sponsors in (iii) Indications for use. For control of § 510.600(c) of this chapter for use as in infections of gastrointestinal paragraph (d) of this section. roundworms (Trichostrongylus, (1) No. 051311 for use as in paragraph Haemonchus, Ostertagia and Cooperia). (d)(1)(i) of this section. (iv) Limitations. Administer to cattle (2) No. 050604 for use as in paragraph on pasture or range accustomed to (d)(1)(ii) of this section. mineral protein block feeding for 3 (3) No. 012286 for use as in paragraph days. Milk taken from animals during (d)(2) of this section. treatment and within 96 hours (8 (c) Related tolerances. See § 556.730 of milkings) after the latest treatment this chapter. must not be used for food. Do not treat (d) Conditions of use. It is used as fol- cattle within 3 days of slaughter. For a lows: satisfactory diagnosis, a microscopic (1) Horses—(i) Route of administration. fecal examination should be performed In feed, as a top dressing. by a veterinarian or diagnostic labora- (a) Amount. 2 grams per 100 pounds of tory prior to worming. Animals main- body weight. tained under conditions of constant (b) Indications for use. For control of worm exposure may require re-treat- large strongyles, small strongyles, ment within 2 to 3 weeks. Animals that pinworms, and threadworms (including are severely parasitized, sick, or off members of the genera Strongylus, feed should be isolated and a veteri- Cyathostomum, Cylicobrachytus, and re- narian consulted for advice concerning lated genera, Craterostomum, treatment. Oesophagodontus, Poteriostomum, Oxyuris, and Strongyloides). [40 FR 13838, Mar. 27, 1975, as amended at 41 (c) Limitations. Add to the usual feed FR 9149, Mar. 3, 1976; 62 FR 63271, Nov. 28, of horses mixed into that amount of 1997; 70 FR 32489, June 3, 2005; 73 FR 35340, the feed normally consumed at one June 23, 2008; 79 FR 28832, May 20, 2014] feeding. Warning: Not for use in horses § 520.2380b Thiabendazole drench or intended for food. paste. (ii) Route of administration. In feed. (a) Amount. 2 grams per 100 pounds of (a) Specifications. Conforms to N.F. body weight. XII. (1) Indications for use. For control of (b) Sponsor. See No. 050604 in large and small strongyles, § 510.600(c) of this chapter. Strongyloides, and pinworms of the gen- (c) Related tolerances. See § 556.730 of era Strongylus, Cyathostomum, this chapter. Cylicobrachytus and related genera, (d) Conditions of use. It is used as fol- Craterostomum, Oesophagodontus, lows:

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(1) Horses. As a single liquid oral Ostertagia spp., and Oesophagostomum dose, administered as a drench or by radiatum). stomach tube; or as an oral paste. (b) Limitations. For most effective re- (i) Amount. 2 grams per 100 pounds of sults, severely parasitized animals or body weight. those constantly exposed to helminth (a) Indications for use. For the control infection should be re-treated every 2 of infections of large strongyles to 3 weeks. Milk taken from treated (Strongylus vulgaris, Strongylus animals within 96 hours (8 milkings) endentatus), small strongyles after the latest treatment must not be (Cyathastomum, Cylicobrachytus and reused for food. Do not treat cattle with- lated genera, Craterostomum, in 3 days of slaughter. For a satisfac- Oesophagodontus, Poteriostomum), tory diagnosis, a microscopic fecal ex- pinworms (Oxyuris), and threadworms amination should be performed prior to (Strongyloides). worming. (b) Limitations. Not for use in horses (ii) Amount. 5 grams per 100 pounds of to be slaughtered for food purposes. body weight. When administered by stomach tube, (a) Indications for use. Control of infor use only by or on the order of a li- fections of Cooperia spp. or severe infec- censed veterinarian. When for use as a tions of other species in paragraph liquid oral drench or an oral paste, con- (e)(3)(i)(a) of this section. sult your veterinarian for assistance in (b) Limitations. For most effective re- the diagnosis, treatment, and control sults, severely parasitized animals or of parasitism. those constantly exposed to helminth (ii) Amount. 4 grams per 100 pounds of body weight. infection should be re-treated every 2 (a) Indications for use. For control of to 3 weeks. Milk taken from treated infections of ascardis (Parascaris). animals within 96 hours (8 milkings) (b) Limitations. Not for use in horses after the latest treatment must not be to be slaughtered for food purposes. used for food. Do not treat cattle with- When administered by stomach tube, in 3 days of slaughter. For a satisfac- use only by or on the order of a li- tory diagnosis, a microscopic fecal ex- censed veterinarian. When for use as a amination should be performed prior to liquid oral drench or an oral paste, con- worming. sult your veterinarian for assistance in (4) Sheep and goats. Orally, as a the diagnosis, treatment, and control drench. of parasitism. (i) Amount. 2 grams per 100 pounds of (2) Pigs. As an oral paste. body weight. (i) Amount. 200 milligrams for each 5 (ii) Indications for use. Control of in- to 7 pounds of body weight per dose. fections of gastrointestinal (ii) Indications for use. For control of roundworms in sheep and goats. infections with Strongyloides ransomi. (Trichostrongylus spp., Haemonchus spp., These infections are commonly found Ostertagia spp., Cooperia spp., in Southeastern United States. Nematodirus spp., Bunostomum spp., (iii) Limitations. Administer to baby Strongyloides spp., Chabertia spp., and pigs (1 to 8 weeks of age). Treatment Oesophagostomum spp.); also active may be repeated in 5 to 7 days if nec- from 3 hours to 3 days following treat- essary. Before treatment, obtain an ac- ment against ova and larvae passed by curate diagnosis from a veterinarian or sheep (good activity against diagnostic laboratory. Do not treat Trichostrongylus colubriformis and axei, within 30 days of slaughter. Ostertagia spp., Bunostomum spp., (3) Cattle. Orally as a drench and in Nematodirus spp., and Strongyloides spp.; paste form using a dosing gun designed less effective against Haemonchus for the product. contortus and Oesophagostomum spp.). (i) Amount. 3 grams per 100 pounds of (iii) Limitations. As a single oral dose; body weight. do not treat animals within 30 days of (a) Indications for use. Control of in- slaughter; milk taken from treated fections of gastrointestinal animals within 96 hours (8 milkings) roundworms (Trichostrongylus spp., after the latest treatment must not be Haemonchus spp., Nematodirus spp., used for food; in severe infections in

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sheep, treatment should be repeated in (b) Limitations. As a single oral dose; 2 to 3 weeks. as a drench or bolus; may repeat once (5) Goats. Orally, as a drench. in 2 to 3 weeks; do not treat animals (i) Amount. 3 grams per 100 pounds of within 3 days of slaughter; milk taken body weight. from treated animals within 96 hours (8 (ii) Indications for use. Control of se- milkings) after the latest treatment vere infections of gastrointestinal must not be used for food. roundworms (Trichostrongylus spp., (2) Sheep and goats. In a bolus. Haemonchus spp., Ostertagia spp., (i) Amount. 2 grams per 100 pounds of Cooperia spp., Nematodirus spp., body weight. Bunostomum spp., Strongyloides spp., Chabertia spp., and Oesophagostomum (ii) Indications for use. Control of in- spp.). fections of gastrointestinal (iii) Limitations. As a single oral dose; roundworms in sheep and goats (gen- do not treat animals within 30 days of eral Trichostrongylus spp., Haemonchus slaughter; milk taken from treated spp., Ostertagia spp., Cooperia spp., animals within 96 hours (8 milkings) Nematodirus spp., Bunostomum spp., after the latest treatment must not be Strongyloides spp., Chabertia spp., and used for food; treatment should be re- Oesophagostomum spp.); also active peated in 2 to 3 weeks. from 3 hours to 3 days following treat- [40 FR 13838, Mar. 27, 1975, as amended at 41 ment against ova and larvae passed by FR 9149, Mar. 3, 1976; 41 FR 47424, Oct. 29, sheep (good activity against T. 1976; 62 FR 63271, Nov. 28, 1997; 79 FR 28832, colubriformis and axei, Ostertagia spp., May 20, 2014] Bunostomum spp., Nematodirus spp., and Strongyloides spp.; less effective against § 520.2380c Thiabendazole bolus. Haemonchus contortus and (a) Specifications. Conforms to N.F. Oesophagostomum spp.). XII. (iii) Limitations. As a single oral dose; (b) Sponsor. See No. 050604 in do not treat animals within 30 days of § 510.600(c) of this chapter. slaughter; milk taken from treated (c) Related tolerances. See § 556.730 of animals within 96 hours (8 milkings) this chapter. after the latest treatment must not be (d) Conditions of use. It is used as fol- used for food; in severe infections in lows: sheep, treatment should be repeated in (1) Cattle. In a bolus. (i) Amount. 3 grams per 100 pounds of 2 to 3 weeks. body weight. (3) Goats. In a bolus. (a) Indications for use. Control of in- (i) Amount. 3 grams per 100 pounds of fections of gastrointestinal body weight. roundworms (general Trichostrongylus (ii) Indications for use. Control of se- spp., Haemonchus spp., Nematodirus spp., vere infections of gastrointestinal Ostertagia spp., and Oesophagostomum roundworms (genera Trichostrongylus radiatum). spp., Haemonchus spp., Ostertagia spp., (b) Limitations. As a single oral dose; Cooperia spp., Nematodirus spp., may repeat once in 2 to 3 weeks; do not Bunostomum spp., Strongyloides spp., treat animals within 3 days of slaugh- Chabertia spp., and Oesophagostomum ter; milk taken from treated animals spp.). within 96 hours (8 milkings) after the (iii) Limitations. As a single oral dose; latest treatment must not be used for do not treat animals within 30 days of food. slaughter; milk taken from treated (ii) Amount. 5 grams per 100 pounds of animals within 96 hours (8 milkings) body weight. after the latest treatment must not be (a) Indications for use. Control of severe infections of gastrointestinal used for food; treatment should be re- roundworms (genera Trichostrongylus peated in 2 to 3 weeks. spp., Haemonchus spp., Nematodirus spp., [40 FR 13838, Mar. 27, 1975, as amended at 41 Ostertagia spp., and Oesophagostomum FR 9149, Mar. 3, 1976; 62 FR 63271, Nov. 28, radiatum). Control of infections with 1997; 79 FR 28832, May 20, 2014] Cooperia spp.

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§ 520.2380d Thiabendazole and piper- eral law restricts this drug to use by or azine citrate. on the order of a licensed veterinarian. (a) Specifications. Each fluid ounce of [40 FR 23071, May 28, 1975, as amended at 48 suspension contains 2 grams of FR 48229, Oct. 18, 1983; 79 FR 28832, May 20, thiabendazole and 2.5 grams of piper- 2014] azine (from piperazine citrate). (b) Sponsor. See No. 050604 in § 520.2380f Thiabendazole and piper- § 510.600(c) of this chapter. azine phosphate. (c) Conditions of use in horses—(1) (a) Specifications. Each ounce of water Amount. Administer 1 ounce of suspen- dispersible powder contains 6.67 grams sion per 100 pounds of body weight by of thiabendazole and 8.33 grams of pi- stomach tube or as a drench. perazine (as piperazine phosphate). (2) Indications for use. For the control (b) Sponsor. See No. 050604 in of large strongyles, small strongyles, § 510.600(c) of this chapter. pinworms, Strongyloides and ascarids (c) Conditions of use in horses—(1) (including members of the genera Amount. 2 grams of thiabendazole and Strongylus spp., Cyathostomum spp., 2.5 grams of piperazine (0.3 ounce of Cylicobrachytus spp. and related genera powder) per 100 pounds of body weight. Craterostomum spp., Oesophagodontus Use a single oral dose. Administer as a spp., Poteriostomum spp., Oxyuris spp., drench or by stomach tube suspended Strongyloides spp., and Parascaris spp.). in 1 pint of warm water; by dose sy- (3) Limitations. Do not use in horses ringe suspended in 1⁄2 ounce of water for intended for human consumption. Fed- each 100 pounds of body weight; or eral law restricts this drug to use by or sprinkled over a small amount of daily on the order of a licensed veterinarian. feed. (2) Indications for use. Treatment of [40 FR 13838, Mar. 27, 1975, as amended at 62 infections of large strongyles (genus FR 63271, Nov. 28, 1997; 79 FR 28832, May 20, 2014] Strongylus), small strongyles (genera Cyathostomum, Cylicobrachytus, and re- § 520.2380e Thiabendazole and lated genera Craterostomum, triclorfon. Oesophagodontus, Poteriostomum), pinworms (Oxyuris), threadworms (a) Specifications. The drug contains 5 (Strongyloides), and ascarids (Parascaris) grams of thiabendazole with 4.5 grams in horses. of trichlorfon, or 20 grams of thiabendazole with 18 grams of (3) Limitations. Do not use in horses trichlorfon. intended for human consumption. If the label bears directions for adminis- (b) Sponsor. See No. 017135 in tration by stomach tube or drench, it § 510.600(c) of this chapter. shall also bear the statement ‘‘Caution: (c) Conditions of use in horses—(1) Federal law restricts this drug to use Amount. Administer 2 grams of by or on the order of a licensed veteri- thiabendazole with 1.8 grams of narian.’’; if not labeled for use by stom- trichlorfon per 100 pounds of body ach tube or drench, the label shall bear weight sprinkled on the animals’ usual the statement, ‘‘Consult your veteri- daily ration of feed, or may be mixed in narian for assistance in the diagnosis, 5 to 10 fluid ounces of water and admin- treatment, and control of parasitism.’’ istered by stomach tube or drench. (2) Indications for use. For the treat- [46 FR 18963, Mar. 27, 1981, as amended at 46 ment and control of bots (Gasterophilus FR 52330, Oct. 27, 1981; 62 FR 63271, Nov. 28, spp.), large strongyles (Strongylus spp.), 1997; 79 FR 28832, May 20, 2014] small strongyles (genera Cyathostomum, Cylicobrachytus, § 520.2455 Tiamulin. Craterostomum, Oesophagodontus, (a) Specifications. (1) Each gram of Poteriostomum), pinworms (Oxyuris spp., soluble powder contains 450 milligrams Strongyloides spp.), and ascarids (mg) tiamulin hydrogen fumarate. (Parascaris spp.). (2) Each milliliter (mL) of solution (3) Limitations. Do not use in horses contains 125 mg (12.5 percent) tiamulin intended for human consumption. Fed- hydrogen fumarate.

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(3) Each mL of solution contains 123 (d) Conditions of use in swine—(1) mg (12.3 percent) tiamulin hydrogen fu- Amount. Administer in drinking water marate. at a concentration of 200 mg per liter (b) Sponsors. See sponsor numbers in for 5 consecutive days. § 510.600(c) of this chapter for use as in (2) Indications for use—(i) For the con- paragraph (d) of this section. trol of swine respiratory disease associ- (1) No. 058198 for products described ated with Pasteurella multocida and in paragraphs (a)(1) and (a)(2) of this Haemophilus parasuis in groups of swine section. in buildings where a respiratory dis- (2) No. 066104 for the product de- ease outbreak is diagnosed. scribed in paragraph (a)(1) of this sec- (ii) For the control of swine res- tion. piratory disease associated with Myco- (3) No. 054771 for the product de- plasma hyopneumoniae in the presence scribed in paragraph (a)(3) of this sec- of Porcine Reproductive and Res- tion. piratory Syndrome Virus (PRRSV) in (c) Related tolerances. See § 556.732 of groups of swine in buildings where a this chapter. respiratory disease outbreak is diag- (d) Conditions of use in swine—(1) nosed. Amounts and indications for use. Admin- (3) Limitations. Swine intended for ister in drinking water for 5 consecu- human consumption must not be tive days: slaughtered within 7 days of the last (i) 3.5 mg per (/) lb of body weight treatment with this product. Federal daily for treatment of swine dysentery law restricts this drug to use by or on associated with Brachyspira the order of a licensed veterinarian. hyodysenteriae susceptible to tiamulin. (ii) 10.5 mg/lb of body weight daily for [79 FR 18158, Apr. 1, 2014, as amended at 81 FR 17608, Mar. 30, 2016; 81 FR 48702, July 26, treatment of swine pneumonia due to 2016] Actinobacillus pleuropneumoniae susceptible to tiamulin. § 520.2473 Tioxidazole oral dosage (2) Limitations. Use as only source of forms. drinking water. Prepare fresh medicated water daily. Withdraw medica- § 520.2473a Tioxidazole granules. tion 3 days before slaughter following (a) Specifications. Each gram of gran- treatment at 3.5 mg/lb and 7 days be- ules contains 200 milligrams of fore slaughter following treatment at tioxidazole. 10.5 mg/lb of body weight. Swine being (b) Sponsor. See No. 000061 in treated with tiamulin should not have § 510.600(c) of this chapter. access to feeds containing polyether (c) Conditions of use—(1) Horses—(i) ionophores (e.g., lasalocid, monensin, Amount. 5 milligrams per pound of body narasin, salinomycin, or weight as a single dose. semduramycin) as adverse reactions (ii) Indications for use. Removal of may occur. The effects of tiamulin on mature large strongyles (Strongylus swine reproductive performance, preg- edentatus, S. equinus, and S. vulgaris), nancy, and lactation have not been de- mature ascarids (Parascaris equorum), termined. mature and immature (4th larval [70 FR 75017, Dec. 19, 2005, as amended at 74 stage) pinworms (Oxyuris equi), and ma- FR 7180, Feb. 13, 2009; 75 FR 54492, Sept. 8, ture small strongyles (Triodontophorus 2010; 77 FR 56770, Sept. 14, 2012; 78 FR 17596, spp.). Mar. 22, 2013; 80 FR 13229, Mar. 13, 2015] (iii) Limitations. For administration with feed: Sprinkle required amount of § 520.2471 Tilmicosin. granules on a small amount of the (a) Specifications. Each milliliter of usual grain ration and mix. Prepare for concentrate solution contains 250 milli- each horse individually. Withholding of grams (mg) tilmicosin as tilmicosin feed or water not necessary. Not for phosphate. use in horses intended for food. The re- (b) Sponsor. See No. 058198 in productive safety of tioxidazole in § 510.600(c) of this chapter. breeding animals has not been deter- (c) Tolerances. See § 556.735 of this mined. Consult your veterinarian for chapter. assistance in the diagnosis, treatment,

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and control of parasitism. It is rec- (iii) Limitations. Federal law restricts ommended that this drug be adminis- this drug to use by or on the order of a tered with caution to sick or debili- licensed veterinarian. tated horses. (2) [Reserved] (2) [Reserved] [74 FR 28875, June 18, 2009, as amended at 79 [50 FR 52772, Dec. 26, 1985; 51 FR 2693, Jan. 21, FR 28832, May 20, 2014] 1986, as amended at 52 FR 7832, Mar. 13, 1987] § 520.2483 Triamcinolone. § 520.2473b Tioxidazole paste. (a) Specifications. (1) Each tablet con- (a) Specifications. Each plastic syringe tains 0.5 milligram (mg) or 1.5 mg contains 6.25 grams of tioxidazole. triamcinolone acetonide. (b) Sponsor. See No. 000061 in (2) Each 15 grams of powder contains § 510.600(c) of this chapter. 10 mg triamcinolone acetonide. (c) Conditions of use—(1) Horses—(i) (b) Sponsor. See No. 000010 in 5 milligrams of tioxidazole per Amount. § 510.600(c) of this chapter. pound of body weight as a single dose. (c) Special considerations. See § 510.410 (ii) Indications for use. Removal of of this chapter. mature large strongyles (Strongylus edentatus, S. equinus, and S. vulgaris), (d) Conditions of use—(1) Dogs and mature ascarids (Parascaris equorum), cats. Use tablets described in paragraph mature and immature (4th larval (a)(1) of this section as follows: stage) pinworms (Oxyuris equi), and ma- (i) Amount. Administer 0.05 mg per ture small strongyles (Triodontophorus pound (/lb) of body weight daily by spp.). mouth; up to 0.1 mg per pound (/lb) of (iii) Limitations. Administer orally by body weight daily, if response to the inserting the nozzle of the syringe smaller dose is inadequate. Therapy through the space between front and may be initiated with a single injec- back teeth and deposit the required tion of triamcinolone acetonide sus- dose on the base of the tongue. Before pension as in § 522.2483 of this chapter, dosing, make sure the horse’s mouth in which case triamcinolone acetonide contains no feed. Not for use in horses tablets should be administered begin- intended for food. The reproductive ning 5 to 7 days after the injection. safety of tioxidazole in breeding ani- (ii) Indications for use. As an anti-in- mals has not been determined. Consult flammatory agent. your veterinarian for assistance in the (iii) Limitations. Federal law restricts diagnosis, treatment, and control of this drug to use by or on the order of a parasitism. It is recommended that licensed veterinarian. this drug be administered with caution (2) Horses. Use oral powder described to sick or debilitated horses. in paragraph (a)(2) of this section as (2) [Reserved] follows: (i) Amount. Administer 0.005 to 0.01 [52 FR 43059, Nov. 9, 1987] mg/lb of body weight twice daily, sprin- § 520.2475 Toceranib. kled (top-dressed) on a small portion of feed. Therapy may be initiated with a (a) Specifications. Each tablet con- single injection of triamcinolone tains 10, 15, or 50 milligrams (mg) acetonide suspension as in § 522.2483 of toceranib as toceranib phosphate. this chapter, in which case (b) Sponsor. See No. 054771 in § 510.600 triamcinolone acetonide oral powder of this chapter. should be administered beginning 3 or 4 (c) Conditions of use—(1) Dogs—(i) days after the injection. Amount. Administer an initial dose of (ii) Indications for use. As an anti-in- 3.25 mg per kilogram (1.48 mg per flammatory agent. pound) body weight, orally every other (iii) Limitations. Federal law restricts day. this drug to use by or on the order of a (ii) Indications for use. For the treat- licensed veterinarian. Do not use in ment of Patnaik grade II or III, recur- horses intended for human consump- rent, cutaneous mast cell tumors with tion. or without regional lymph node involvement. [75 FR 10166, Mar. 5, 2010]

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§ 520.2520 Trichlorfon oral dosage (2) Indications for use. For horses for forms. removal of bots (Gastrophilus nasalis, Gastrophilus intestinalis), large § 520.2520a Trichlorfon and atropine. roundworms (ascarids, Parascaris (a) Specifications. (1) For trichlorfon: equorum), and pinworms (Oxyuris equi). O,O-Dimethyl 2,2,2-trichloro-1-hydroxy- (3) Limitations. Do not use in horses ethyl phosphonate. intended for human consumption. Fed- (2) For atropine: Atropine N.F. eral law restricts this drug to use by or (b) Sponsor. See No. 054771 in on the order of a licensed veterinarian. § 510.600(c) of this chapter. [45 FR 48128, July 18, 1980. Redesignated and (c) Conditions of use in mice—(1) amended at 79 FR 28833, May 20, 2014] Amount. Administer 1.67 grams of trichlorfon and 7.7 milligrams of atro- § 520.2520d Trichlorfon, pine per liter continuously for 7 to 14 phenothiazine, and piperazine days as the sole source of drinking dihydrochloride powder. water. (a) Specifications. Each 54.10 grams (2) Indications for use. For the treat- (1.91 ounces) of water dispersible pow- ment of Syphacia obvelata (pinworm) in der contains 9.10 grams of trichlorfon, laboratory mice. 6.25 grams of phenothiazine, and the (3) Limitations. Federal law restricts equivalent of 20.0 grams of piperazine this drug to use by or on the order of a base (as piperazine dihydrochloride). licensed veterinarian. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. [79 FR 28832, May 20, 2014] [48 FR 2757, Jan. 21, 1983. Redesignated and § 520.2520b Trichlorfon boluses. amended at 79 FR 28833, May 20, 2014]

(a) Specifications. Each bolus contains EDITORIAL NOTE: At 79 FR 28833, May 20, either 7.3, 10.9, 14.6, or 18.2 g of 2014, § 520.2520d was amended in part by redes- trichlorfon. ignating paragraph (e) as (c). This action (b) Sponsor. See No. 054771 in could not be performed because paragraph (e) § 510.600(c) of this chapter. did not exist. (c) Conditions of use in horses—(1) § 520.2582 Triflupromazine. Amount. 18.2 milligrams per pound of body weight, except for strongyles use (a) Specifications. Each tablet con- 36.4 milligrams per pound of body tains 10 or 25 milligrams (mg) weight. triflupromazine hydrochloride. (2) Indications for use. For horses for (b) Sponsor. See No. 054771 in removal of bots (Gastrophilus nasalis, § 510.600(c) of this chapter. Gastrophilus intestinalis), large (c) Conditions of use in dogs and cats— strongyles (Strongylus vulgaris), small (1) Amount. Administer orally 1 to 2 mg strongyles, large roundworms per pound of body weight daily, fol- (ascarids, Parascaris equorum), and lowed by 1 mg daily. pinworms (Oxyuris equi). (2) Indications for use. For relief of (3) Limitations. Do not use in horses anxiety, to help control psychomotor intended for human consumption. Fed- over-activity, and to increase the toler- eral law restricts this drug to use by or ance of animals to pain and pruritus. on the order of a licensed veterinarian. For use in various clinical procedures which require the aid of a tranquilizer, [45 FR 48127, July 18, 1980. Redesignated and antiemetic, or preanesthetic. amended at 79 FR 28833, May 20, 2014] (3) Limitations. Federal law restricts § 520.2520c Trichlorfon granules. this drug to use by or on the order of a licensed veterinarian. (a) Specifications. Each package contains either 18.2 or 36.4 g of trichlorfon. [79 FR 28833, May 20, 2014] (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 520.2598 Trilostane. (c) Conditions of use in horses—(1) (a) Specifications. Each capsule con- Amount. 18.2 milligrams per pound of tains 5, 10, 30, 60, or 120 milligrams body weight. (mg) trilostane.

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(b) Sponsor. See No. 043264 in § 510.600 § 520.2605 Trimeprazine and prednis- of this chapter. olone capsules. (c) Conditions of use in dogs—(1) (a) Specifications. Each capsule con- Amount. The starting dose is 1.0 to 3.0 tains: milligrams per pound (2.2 to 6.7 milli- (1) 3.75 milligrams (mg) trimeprazine grams per kilogram) once a day. in sustained released form (as (2) Indications for use. For treatment trimeprazine tartrate) and 1 mg pred- of pituitary-dependent nisolone (Capsule No. 1); or hyperadrenocorticism. For treatment (2) 7.5 mg trimeprazine in sustained of hyperadrenocorticism due to release form (as trimeprazine tartrate) adrenocortical tumor. and 2 mg prednisolone (Capsule No. 2). (b) Sponsor. See No. 054771 in (3) Limitations. Federal law restricts § 510.600(c) of this chapter. this drug to use by or on the order of a (c) Conditions of use in dogs—(1) licensed veterinarian. Amount. Administer orally once daily [74 FR 21767, May 11, 2009, as amended at 74 an initial dosage: FR 30464, June 26, 2009; 80 FR 53460, Sept. 4, (i) For dogs weighing up to 10 pounds: 2015] one Capsule No. 1; (ii) For dogs weighing 11 to 20 § 520.2604 Trimeprazine and prednis- pounds, one Capsule No. 2 or two Cap- olone tablets. sule No. 1; (a) Specifications. Each tablet con- (iii) For dogs weighing 21 to 40 tains 5 milligrams (mg) trimeprazine pounds, two Capsule No. 2 or four Cap- tartrate and 2 mg prednisolone. sule No. 1; and (iv) For dogs weighing over 40 (b) Sponsor. See No. 054771 in pounds, three Capsule No. 2 or six Cap- § 510.600(c) of this chapter. sule No. 1. After 4 days, the dosage is (c) Conditions of use in dogs—(1) reduced to approximately 1⁄2 the initial Amount. Administer orally an initial dosage or to an amount just sufficient dosage: for dogs weighing up to 10 to maintain remission of symptoms. pounds, 1⁄2 tablet twice daily; for dogs (2) Indications for use. For the relief of weighing 11 to 20 pounds, 1 tablet twice itching regardless of cause; and for re- daily; for dogs weighing 21 to 40 duction of inflammation commonly as- pounds, 2 tablets twice daily; and for sociated with most skin disorders of dogs weighing over 40 pounds, 3 tablets dogs such as eczema, caused by inter- twice daily. After 4 days, reduce dosage nal disorders, otitis, and dermatitis, al- to one-half the initial dose or to an lergic, parasitic, pustular and nonspe- amount sufficient to maintain remis- cific. As adjunctive therapy in various sion of symptoms. cough conditions including treatment (2) Indications for use. For the relief of of ‘‘kennel cough’’ or tracheobronchitis, bronchitis including itching regardless of cause; and for re- allergic bronchitis, in tonsillitis, acute duction of inflammation commonly as- upper respiratory infections and sociated with most skin disorders of coughs of nonspecific origin. dogs such as eczema, caused by inter- (3) Limitations. Federal law restricts nal disorders, otitis, and dermatitis, al- this drug to use by or on the order of a lergic, parasitic, pustular and nonspe- licensed veterinarian. cific. As adjunctive therapy in various cough conditions including treatment [79 FR 28833, May 20, 2014] of ‘‘kennel cough’’ or § 520.2610 Trimethoprim and sulfa- tracheobronchitis, bronchitis including diazine tablets. allergic bronchitis, in tonsillitis, acute (a) Specifications. Each tablet con- upper respiratory infections and tains 30 milligrams (mg) (5 mg coughs of nonspecific origin. trimethoprim and 25 mg sulfadiazine), (3) Limitations. Federal law restricts 120 mg (20 mg trimethoprim and 100 mg this drug to use by or on the order of a sulfadiazine), 480 mg (80 mg licensed veterinarian. trimethoprim and 400 mg sulfadiazine) or 960 mg (160 mg trimethoprim and 800 [79 FR 28833, May 20, 2014] mg sulfadiazine).

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(b) Sponsors. See Nos. 000061 and infections, and wound infections and 054771 in § 510.600(c) of this chapter. abscesses. (c) Conditions of use in dogs—(1) (3) Limitations. Not for use in horses Amount. Administer orally at 30 mg per intended for human consumption. Fed- kilogram of body weight (14 milligrams eral law restricts this drug to use by or per pound) once daily. Alternatively, on the order of a licensed veterinarian. especially in severe infections, the initial dose may be followed by one-half [71 FR 30802, May 31, 2006, as amended at 79 the recommended daily dose every 12 FR 28834, May 20, 2014] hours. Administer for 2 to 3 days after § 520.2612 Trimethoprim and sulfa- symptoms have subsided. Do not treat diazine suspension. for more than 14 consecutive days. (2) Indications for use. The drug is (a) Specifications. Each milliliter used in dogs where systemic anti- (mL) of suspension contains: bacterial action against sensitive orga- (1) 10 milligrams (mg) trimethoprim nisms is required, either alone or as an and 50 mg sulfadiazine; or adjunct to surgery or debridement with (2) 400 mg combined active ingredi- associated infection. The drug is indi- ents (67 mg trimethoprim and 333 mg cated where control of bacterial infec- sulfadiazine). tion is required during the treatment (b) Sponsors. See sponsor numbers in of acute urinary tract infections, acute § 510.600 of this chapter: bacterial complications of distemper, (1) No. 000061 for use of product de- acute respiratory tract infections, scribed in paragraph (a)(1) for use as in acute alimentary tract infections, paragraph (c)(1) of this section. wound infections, and abscesses. (2) No. 051072 for use of product de- (3) Limitations. Federal law restricts scribed in paragraph (a)(2) for use as in this drug to use by or on the order of a paragraph (c)(2) of this section. licensed veterinarian. (c) Conditions of use—(1) Dogs—(i) [79 FR 28833, May 20, 2014] Amount. Administer 1 mL (10 mg trimethoprim and 50 mg sulfadiazine) § 520.2611 Trimethoprim and sulfa- per 5 pounds (lb) of body weight once diazine paste. daily, or one-half the recommended (a) Specifications. Each gram (g) of daily dose every 12 hours, for up to 14 paste contains 67 milligrams (mg) consecutive days. trimethoprim and 333 mg sulfadiazine. (ii) Indications for use. The drug is (b) Sponsors. See sponsors in used in dogs where systemic anti- § 510.600(c) of this chapter: bacterial action against sensitive orga- (1) No. 054771 for product adminis- nisms is required, either alone or as an tered as in paragraph (c)(1)(i) of this adjunct to surgery or debridement with section. associated infection. The drug is indi- (2) No. 000061 for product adminis- cated where control of bacterial infec- tered as in paragraph (c)(1)(ii) of this tion is required during the treatment section. of acute urinary tract infections, acute (c) Conditions of use in horses—(1) bacterial complications of distemper, Amount. Administer orally as a single acute respiratory tract infections, daily dose for 5 to 7 days: acute alimentary tract infections, (i) 5 g of paste (335 mg trimethoprim wound infections, and abscesses. and 1,665 mg sulfadiazine) per 150 (iii) Limitations. Federal law restricts pounds (68 kilograms) of body weight this drug to use by or on the order of a per day. licensed veterinarian. (ii) 3.75 g of paste (250 mg (2) Horses—(i) Amount. Administer 24 trimethoprim and 1,250 mg sulfa- mg combined active ingredients per diazine) per 110 pounds (50 kilograms) kilogram of body weight (2.7 mL/100 lb) of body weight per day. twice daily for 10 days. (2) Indications for use. For use where (ii) Indications for use. For the treat- systemic antibacterial action against ment of lower respiratory tract infec- sensitive organisms is required during tions in horses caused by susceptible treatment of acute strangles, res- strains of Streptococcus equi subsp. piratory infections, acute urogenital zooepidemicus.

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(iii) Limitations. Do not use in horses sociated with Mycoplasma synoviae in intended for human consumption. Fed- broiler chickens. Treated chickens eral law restricts this drug to use by or should consume enough medicated on the order of a licensed veterinarian. drinking water to provide 50 milli- [78 FR 63872, Oct. 25, 2013] grams (mg) tylosin per pound of body weight per day. § 520.2613 Trimethoprim and sulfa- (B) Administer 851 to 1,419 mg/gallon diazine powder. (225 to 375 ppm) for 5 days for the con- (a) Specifications. Each gram of pow- trol of mortality caused by necrotic en- der contains 67 milligrams (mg) teritis associated with Clostridium trimethoprim and 333 mg sulfadiazine. perfringens in broiler chickens. (b) Sponsors. See Nos. 054771 and (ii) Limitations. Do not use in layers 059051 in § 510.600(c) of this chapter. producing eggs for human consump- (c) Conditions of use in horses—(1) tion. Do not administer within 24 hours Amount. Administer orally 3.75 grams of slaughter. of powder per 110 pounds (50 kilograms) (2) Turkeys—(i) Amount. 2 grams per of body weight in a small amount of gallon for 2 to 5 days as the sole source feed, as a single daily dose, for 5 to 7 of drinking water. Treated turkeys days. should consume enough medicated (2) Indications for use. For control of drinking water to provide 60 mg tylosin bacterial infections of horses during per pound of body weight per day. treatment of acute strangles, res- (ii) Indications for use. For the reduc- piratory tract infections, acute uro- tion in severity of effects of infectious genital infections, wound infections, sinusitis associated with Mycoplasma and abscesses. gallisepticum. (3) Limitations. Do not use in horses (iii) Limitations. Do not use in layers intended for human consumption. Fed- producing eggs for human consump- eral law restricts this drug to use by or tion. Do not administer within 5 days on the order of a licensed veterinarian. of slaughter. [58 FR 36135, July 6, 1993, as amended at 64 (3) Swine—(i) Amount. 250 mg per gal- FR 68289, Dec. 7, 1999; 79 FR 28834, May 20, lon as the only source of drinking 2014; 79 FR 64116, Oct. 28, 2014] water for 3 to 10 days, depending on the § 520.2640 Tylosin. severity of the condition being treated. (ii) Indications for use. (A) For the (a) Specifications. Each container of treatment and control of swine dys- soluble powder contains tylosin tar- entery associated with Brachyspira trate equivalent to either 100 or 256 hyodysenteriae when followed imme- grams tylosin base. diately by tylosin phosphate medicated (b) Sponsors—(1) No. 058198 for use as feed; and for the control of porcine pro- in paragraph (e) of this section. liferative enteropathies (PPE, ileitis) (2) Nos. 016592 and 061623 for use as in associated with Lawsonia intracellularis paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2), when followed immediately by tylosin (e)(3), and (e)(4) of this section. phosphate medicated feed. (c) Related tolerances. See § 556.740 of this chapter. (B) For the treatment and control of (d) Special considerations. Federal law swine dysentery associated with restricts this drug to use by or on the Brachyspira hyodysenteriae. order of a licensed veterinarian. (iii) Limitations. Do not administer (e) Conditions of use—(1) Chickens—(i) within 48 hours of slaughter. As indi- Amounts and indications for use. (A) Ad- cated in paragraph (d)(3)(ii)(A) of this minister 2 grams per gallon (528 parts section, follow with tylosin phosphate per million (ppm)) for 1 to 5 days as an medicated feed as in § 558.625(f)(1)(vi)(c) aid in the treatment of chronic res- of this chapter. piratory disease (CRD) associated with (4) Honey bees—(i) Amount. Mix 200 Mycoplasma gallisepticum in broiler and milligrams tylosin in 20 grams confec- replacement chickens. For the control tioners’/powdered sugar. Use imme- of CRD associated with M. gallisepticum diately. Apply (dust) this mixture over at time of vaccination or other stress the top bars of the brood chamber once in chickens. For the control of CRD as- weekly for 3 weeks.

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(ii) Indications for use. For the control 522.82 Aminopropazine. of American foulbrood (Paenibacillus 522.84 Beta-aminopropionitrile. larvae). 522.88 Amoxicillin. 522.90 Ampicillin injectable dosage forms. (iii) Limitations. The drug should be 522.90a Ampicillin trihydrate suspension. fed early in the spring or fall and con- 522.90b Ampicillin trihydrate powder for in- sumed by the bees before the main jection. honey flow begins, to avoid contamina- 522.90c Ampicillin sodium. tion of production honey. Complete 522.144 Arsenamide. treatments at least 4 weeks before 522.147 Atipamezole. main honey flow. 522.150 Azaperone. 522.161 Betamethasone. [40 FR 13838, Mar. 27, 1975, as amended at 50 522.163 Betamethasone dipropionate and FR 49841, Dec. 5, 1985; 59 FR 14365, Mar. 28, betamethasone sodium phosphate aque- 1994; 62 FR 39443, July 23, 1997; 68 FR 24879, ous suspension. May 9, 2003; 70 FR 69439, Nov. 16, 2005; 73 FR 522.167 Betamethasone sodium phosphate 76946, Dec. 18, 2008; 75 FR 76259, Dec. 8, 2010; and betamethasone acetate. 76 FR 59024, Sept. 23, 2011; 77 FR 29217, May 522.204 Boldenone. 17, 2012; 79 FR 37620, July 2, 2014; 79 FR 53136, 522.224 Bupivacaine. Sept. 8, 2014; 79 FR 64116, Oct. 28, 2014; 80 FR 522.230 Buprenorphine. 34278, June 16, 2015; 81 FR 48702, July 26, 2016] 522.234 Butamisole. 522.246 Butorphanol. § 520.2645 Tylvalosin. 522.275 N-Butylscopolammonium. 522.300 Carfentanil. (a) Specifications. Granules containing 522.304 Carprofen. 62.5 percent tylvalosin (w/w) as 522.311 Cefovecin. tylvalosin tartrate. 522.313 Ceftiofur injectable dosage forms. (b) Sponsor. See No. 066916 in 522.313a Ceftiofur crystalline free acid. § 510.600(c) of this chapter. 522.313b Ceftiofur hydrochloride. (c) Related tolerances. See § 556.748 of 522.313c Ceftiofur sodium. this chapter. 522.380 Chloral hydrate, pentobarbital, and magnesium sulfate. (d) Conditions of use in swine—(1) 522.390 Chloramphenicol. Amount. Administer 50 parts per mil- 522.454 Clodronate. lion (ppm) tylvalosin continuously in 522.460 Cloprostenol. drinking water for 5 consecutive days. 522.468 Colistimethate sodium powder for (2) Indications for use. For control of injection. porcine proliferative enteropathy 522.480 Corticotropin. (PPE) associated with Lawsonia 522.518 Cupric glycinate injection. 522.522 Danofloxacin. intracellularis infection in groups of 522.533 Deslorelin. swine in buildings experiencing an out- 522.535 Desoxycorticosterone. break of PPE; and for control of swine 522.536 Detomidine. respiratory disease (SRD) associated 522.540 Dexamethasone solution. with Bordetella bronchiseptica, 522.542 Dexamethasone suspension. Haemophilus parasuis, Pasteurella 522.558 Dexmedetomidine. multocida, and Streptococcus suis in 522.563 Diatrizoate. groups of swine in buildings experi- 522.650 Dihydrostreptomycin sulfate injection. encing an outbreak of SRD. 522.690 Dinoprost. (3) Limitations. Federal law restricts 522.723 Diprenorphine. this drug to use by or on the order of a 522.770 Doramectin. licensed veterinarian. 522.775 Doxapram. 522.784 Doxylamine. [77 FR 55415, Sept. 10, 2012, as amended at 83 522.800 Droperidol and fentanyl. FR 13635, Mar. 30, 2018] 522.810 Embutramide, chloroquine, and lidocaine solution. PART 522—IMPLANTATION OR 522.812 Enrofloxacin. 522.814 Eprinomectin. INJECTABLE DOSAGE FORM NEW 522.820 Erythromycin. ANIMAL DRUGS 522.840 Estradiol. 522.842 Estradiol benzoate and testosterone Sec. propionate. 522.23 Acepromazine. 522.850 Estradiol valerate and norgestomet 522.52 Alfaxalone. in combination. 522.56 Amikacin. 522.863 Ethylisobutrazine. 522.62 Aminopentamide. 522.870 Etodolac.

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522.883 Etorphine. 522.1660 Oxytetracycline injectable dosage 522.900 Euthanasia solution. forms. 522.914 Fenprostalene. 522.1660a Oxytetracycline solution, 200 mil- 522.930 Firocoxib. ligrams/milliliter. 522.955 Florfenicol. 522.1660b Oxytetracycline solution, 300 mil- 522.956 Florfenicol and flunixin. ligrams/milliliter. 522.960 Flumethasone injectable dosage 522.1662 Oxytetracycline hydrochloride im- forms. plantation or injectable dosage forms. 522.960a Flumethasone suspension. 522.1662a Oxytetracycline hydrochloride in- 522.960b Flumethasone acetate solution. jection. 522.960c Flumethasone solution. 522.1662b Oxytetracycline hydrochloride 522.970 Flunixin. with lidocaine injection. 522.995 Fluprostenol. 522.1662 Oxytetracycline and flunixin. 522.1002 Follicle stimulating hormone. 522.1680 Oxytocin. 522.1010 Furosemide. 522.1684 Pegbovigrastim. 522.1014 Gamithromycin. 522.1696 Penicillin G procaine injectable 522.1020 Gelatin. dosage forms. 522.1044 Gentamicin. 522.1696a Penicillin G benzathine and peni- 522.1055 Gleptoferron. cillin G procaine suspension. 522.1066 Glycopyrrolate. 522.1696b Penicillin G procaine aqueous sus- 522.1077 Gonadorelin. pension. 522.1079 Serum gonadotropin and chorionic 522.1696c Penicillin G procaine in oil. gonadotropin. 522.1698 Pentazocine. 522.1081 Chorionic gonadotropin for injec- 522.1704 Pentobarbital. 522.1720 Phenylbutazone. tion; chorionic gonadotropin suspension. 522.1820 Pituitary luteinizing hormone pow- 522.1083 Gonadotropin releasing factor ana- der for injection. log-diphtheria toxoid conjugate. 522.1850 Polysulfated glycosaminoglycan. 522.1085 Guaifenesin powder for injection. 522.1862 Pralidoxime powder for injection. 522.1086 Guaifenesin solution. 522.1870 Praziquantel. 522.1125 Hemoglobin glutamer-200 (bovine). 522.1881 Prednisolone acetate. 522.1145 Hyaluronate. 522.1883 Prednisolone sodium phosphate. 522.1150 Hydrochlorothiazide. 522.1884 Prednisolone sodium succinate. 522.1155 Imidocarb powder for injection. 522.1885 Prednisolone tertiary butylacetate. 522.1156 Imidocarb solution. 522.1890 Sterile prednisone suspension. 522.1160 Insulin. 522.1920 Prochlorperazine and isopropamide. 522.1182 Iron injection. 522.1940 Progesterone and estradiol ben- 522.1185 Isoflupredone. zoate. 522.1192 Ivermectin. 522.1962 Promazine. 522.1193 Ivermectin and clorsulon. 522.2002 Propiopromazine. 522.1204 Kanamycin. 522.2005 Propofol. 522.1222 Ketamine. 522.2012 Prostalene. 522.1223 Ketamine, promazine, and 522.2063 Pyrilamine. aminopentamide. 522.2075 Robenacoxib. 522.1225 Ketoprofen. 522.2076 Romifidine. 522.1242 Levamisole. 522.2100 Selenium and vitamin E. 522.1260 Lincomycin. 522.2112 Sometribove zinc suspension. 522.1289 Lufenuron. 522.2120 Spectinomycin dihydrochloride in- 522.1290 Luprostiol. jection. 522.1315 Maropitant. 522.2121 Spectinomycin sulfate. 522.1335 Medetomidine. 522.2150 Stanozolol. 522.1350 Melatonin implant. 522.2200 Sulfachlorpyridazine. 522.1362 Melarsomine powder for injection. 522.2220 Sulfadimethoxine. 522.1367 Meloxicam. 522.2240 Sulfaethoxypyridazine. 522.1372 Mepivacaine. 522.2260 Sulfamethazine. 522.1380 Methocarbamol. 522.2340 Sulfomyxin. 522.1410 Methylprednisolone. 522.2404 Thialbarbitone sodium for injec- 522.1450 Moxidectin solution. tion. 522.1451 Moxidectin microspheres for injec- 522.2424 Thiamylal. tion. 522.2444 Thiopental injectable dosage forms. 522.1452 Nalorphine. 522.2444a Thiopental powder for injection. 522.1465 Naltrexone. 522.2444b Thiopental and pentobarbital pow- 522.1468 Naproxen for injection. der for injection. 522.1484 Neomycin. 522.2460 Tildipirosin. 522.1503 Neostigmine. 522.2470 Tiletamine and zolazepam for injec- 522.1610 Oleate sodium. tion. 522.1620 Orgotein for injection. 522.2471 Tilmicosin.

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522.2473 Tiludronate. preanesthetized cats; a dose containing 522.2474 Tolazoline. 1.4 to 1.5 mg/kg provides an additional 522.2476 Trenbolone acetate. 3 to 5 minutes anesthesia in 522.2477 Trenbolone acetate and estradiol. 522.2478 Trenbolone acetate and estradiol unpreanesthetized cats. benzoate. (ii) Dogs—(A) Induction of general an- 522.2483 Triamcinolone. esthesia. Administer by intravenous in- 522.2582 Triflupromazine. jection over approximately 60 seconds 522.2610 Trimethoprim and sulfadiazine. or until clinical signs show the onset of 522.2615 Tripelennamine. anesthesia, 1.5 to 4.5 mg/kg for dogs 522.2630 Tulathromycin. 522.2640 Tylosin. that did not receive a preanesthetic or 522.2662 Xylazine. 0.2 to 3.5 mg/kg for dogs that received 522.2670 Yohimbine. a preanesthetic. 522.2680 Zeranol. (B) Maintenance of general anesthesia 522.2690 Zinc gluconate. following induction. Administer an in- AUTHORITY: 21 U.S.C. 360b. travenous bolus containing 1.2 to 1.4 mg/kg to provide an additional 6 to 8 SOURCE: 40 FR 13858, Mar. 27, 1975, unless otherwise noted. minutes of anesthesia in preanesthetized dogs; a dose of 1.5 to § 522.23 Acepromazine. 2.2 mg/kg provides an additional 6 to 8 (a) Specifications. Each milliliter of minutes of anesthesia in solution contains 10 milligrams (mg) unpreanesthetized dogs. acepromazine maleate. (2) Indications for use. For the induc- (b) Sponsors. See Nos. 000010 and tion and maintenance of anesthesia 000859 in § 510.600(c) of this chapter: and for induction of anesthesia fol- (c) Conditions of use in dogs, cats, and lowed by maintenance with an inhalant horses—(1) Amount. Dogs: 0.25 to 0.5 mg anesthetic, in dogs and cats. per pound (/lb) of body weight; Cats: 0.5 (3) Limitations. Federal law restricts to 1.0 mg/lb of body weight; Horses: 2.0 this drug to use by or on the order of a to 4.0 mg per 100 lbs of body weight. licensed veterinarian. Alfaxalone is a (2) Indications for use. For use as a Class IV controlled substance. tranquilizer and as a preanesthetic agent. [77 FR 64717, Oct. 23, 2012, as amended at 79 FR 64116, Oct. 28, 2014] (3) Limitations. Do not use in horses intended for human consumption. Fed- § 522.56 Amikacin. eral law restricts this drug to use by or on the order of a licensed veterinarian. (a) Specifications. Each milliliter of solution contains 50 milligrams (mg) of [75 FR 10167, Mar. 5, 2010; 78 FR 17597, Mar. 22, amikacin as amikacin sulfate. 2013; 79 FR 16182, Mar. 25, 2014] (b) Sponsor. See No. 069043 in § 522.52 Alfaxalone. § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) (a) Specifications. Each milliliter con- Amount. 5 mg/pound (lb) of body weight tains 10 milligrams (mg) alfaxalone. twice daily by intramuscular or sub- (b) Sponsor. See No. 049480 in cutaneous injection. § 510.600(c) of this chapter. (c) Conditions of use in cats and dogs— (2) Indications for use. For treatment (1) Amount—(i) Cats—(A) Induction of of genitourinary tract infections (cys- general anesthesia. Administer by intra- titis) caused by susceptible strains of venous injection over approximately 60 Escherichia coli and Proteus spp. and seconds or until clinical signs show the skin and soft tissue infections caused onset of anesthesia, 2.2 to 9.7 mg/kilo- by susceptible strains of Pseudomonas gram (kg) for cats that did not receive spp. and E. coli. a preanesthetic or 1.0 to 10.8 mg/kg for (3) Limitations. Do not use in horses cats that received a preanesthetic. intended for human consumption. Fed- (B) Maintenance of general anesthesia eral law restricts this drug to use by or following induction. Administer an in- on the order of a licensed veterinarian. travenous bolus containing 1.1 to 1.3 [76 FR 17338, Mar. 29, 2011, as amended at 78 mg/kg to provide an additional 7 to 8 FR 17597, Mar. 22, 2013; 79 FR 16183, Mar. 25, minutes of anesthesia in 2014; 81 FR 17608, Mar. 30, 2016]

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§ 522.62 Aminopentamide. eral law restricts this drug to use by or on the order of a licensed veterinarian. (a) Specifications. Each milliliter of solution contains 0.5 milligram (mg) [79 FR 16183, Mar. 25, 2014] aminopentamide hydrogen sulfate. (b) Sponsor. See No. 054771 in § 522.84 Beta-aminopropionitrile. § 510.600(c) of this chapter. (a) Specifications. The drug is a sterile (c) Conditions of use in dogs and cats— powder. Each milliliter of constituted (1) Amount. Administer by subcuta- solution contains 0.7 milligrams (mg) neous or intramuscular injection every beta-aminopropionitrile fumarate. 8 to 12 hours as follows: For animals (b) Sponsor. See No. 064146 in weighing up to 10 pounds (lbs): 0.1 mg; § 510.600(c) of this chapter. For animals weighing 11 to 20 lbs: 0.2 (c) Conditions of use in horses—(1) mg; For animals weighing 21 to 50 lbs: Amount. Administer 7 mg by 0.3 mg; For animals weighing 51 to 100 intralesional injection every other day lbs: 0.4 mg; For animals weighing over for five treatments beginning about 30 100 lbs: 0.5 mg. Dosage may be gradu- days after initial injury. ally increased up to a maximum of five (2) Indications for use in horses. For times the suggested dosage. Following treatment of tendinitis of the super- parenteral use, dosage may be contin- ficial digital flexor tendon (SDFT) in ued by oral administration of tablets. horses where there is sonographic evi- (2) Indications for use. For the treat- dence of fiber tearing. ment of vomiting and/or diarrhea, nau- (3) Limitations. Do not use in horses sea, acute abdominal visceral spasm, intended for human consumption. Fed- pylorospasm, or hypertrophic gastritis. eral law restricts this drug to use by or (3) Limitations. Federal law restricts on the order of a licensed veterinarian. this drug to use by or on the order of a [79 FR 16183, Mar. 25, 2014] licensed veterinarian. [79 FR 16183, Mar. 25, 2014] § 522.88 Amoxicillin. (a) Specifications—(1) Each vial con- § 522.82 Aminopropazine. tains 3 grams (g) of amoxicillin tri- (a) Specifications. Each milliliter of hydrate. Each milliliter of constituted solution contains aminopropazine fu- suspension contains 100 or 250 milli- marate equivalent to 25 milligrams grams (mg) amoxicillin trihydrate for (mg) aminopropazine base. use as in paragraph (d)(1) of this sec- (b) Sponsor. See No. 000061 in tion. § 510.600(c) of this chapter. (2) Each vial contains 25 g of (c) Conditions of use—(1) Dogs and amoxicillin trihydrate. Each milliliter cats—(i) Amount. 1 to 2 mg per pound of of constituted suspension contains 250 body weight, repeated every 12 hours as mg amoxicillin trihydrate for use as in indicated, by intramuscular or intra- paragraph (d)(2) of this section. venous injection. (b) Sponsor. See No. 054771 in (ii) Indications for use. For reducing § 510.600(c) of this chapter. excessive smooth muscle contractions, (c) Related tolerance. See § 556.38 of such as occur in urethral spasms asso- this chapter. ciated with urolithiasis. (d) Conditions of use—(1) Dogs and (iii) Limitations. Federal law restricts cats—(i) Amount. Administer 5 mg per this drug to use by or on the order of a pound of body weight daily for up to 5 licensed veterinarian. days by intramuscular or subcutaneous (2) Horses—(i) Amount. Administer injection. 0.25 mg per pound of body weight, re- (ii) Indications for use—(A) Dogs. For peated every 12 hours as indicated, by treatment of infections caused by sus- intramuscular or intravenous injec- ceptible strains of organisms as fol- tion. lows: Respiratory infections (tonsil- (ii) Indications for use. For reducing litis, tracheobronchitis) due to Staphy- excessive smooth muscle contractions, lococcus aureus, Streptococcus spp., Esch- such as occur in colic spasms. erichia coli, and Proteus mirabilis; geni- (iii) Limitations. Do not use in horses tourinary infections (cystitis) due to S. intended for human consumption. Fed- aureus, Streptococcus spp., E. coli, and P.

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mirabilis; gastrointestinal infections § 522.90a Ampicillin trihydrate suspen- (bacterial gastroenteritis) due to S. sion. aureus, Streptococcus spp., E. coli, and P. (a) Specifications. (1) Each milliliter mirabilis; bacterial dermatitis due to S. contains ampicillin trihydrate equiva- aureus, Streptococcus spp., and P. lent to 200 milligrams (mg) of ampi- mirabilis; soft tissue infections (ab- cillin. scesses, lacerations, and wounds), due (2) Each milliliter contains ampi- to S. aureus, Streptococcus spp., E. coli, cillin trihydrate equivalent to 150 mg and P. mirabilis. of ampicillin. (B) Cats. For treatment of infections (b) Sponsors. See sponsor numbers in caused by susceptible strains of orga- § 510.600(c) of this chapter. nisms as follows: Upper respiratory in- (1) No. 054771 for use of product de- fections due to S. aureus, Staphy- scribed in paragraph (a)(1) as in para- lococcus spp., Streptococcus spp., graphs (d)(1), (d)(2), (d)(3)(i)(A), Haemophilus spp., E. coli, Pasteurella (d)(3)(ii)(A), (d)(3)(iii), and (d)(4) of this spp., and P. mirabilis; genitourinary in- section. fections (cystitis) due to S. aureus, (2) No. 054771 for use of product described in paragraph (a)(2) as in para- Streptococcus spp., E. coli, P. mirabilis, graphs (d)(3)(i)(B), (d)(3)(ii)(B), and and Corynebacterium spp.; gastro- (d)(3)(iii) of this section. intestinal infections due to E. coli, Pro- (c) Related tolerances. See § 556.40 of teus spp., Staphylococcus spp., and Strep- this chapter. tococcus spp.; skin and soft tissue infec- (d) Conditions of use—(1) Cattle—(i) tions (abscesses, lacerations, and Amount. For enteritis: 3 mg per pound wounds) due to S. aureus, Staphy- of body weight, intramuscularly, once lococcus spp., Streptococcus spp., E. coli, or twice daily, for up to 3 days. For and Pasteurella multocida. pneumonia: 3 mg per pound of body (iii) Limitations. Federal law restricts weight, intramuscularly, twice daily, this drug to use by or on the order of a for up to 3 days. licensed veterinarian. (ii) Indications for use. For treatment (2) Cattle—(i) Amount. Administer 3 to of bacterial enteritis in calves caused 5 mg per pound of body weight daily for by Escherichia coli and bacterial pneu- up to 5 days by intramuscular or sub- monia caused by Pasteurella spp. sus- cutaneous injection. ceptible to ampicillin. (ii) Indications for use. For treatment (iii) Limitations. Treated animals of diseases due to amoxicillin-suscep- must not be slaughtered for food use tible organisms as follows: Respiratory during treatment or for 9 days after tract infections (shipping fever, pneu- the last treatment. Federal law re- monia) due to P. multocida, P. stricts this drug to use by or on the hemolytica, Haemophilus spp., Staphy- order of a licensed veterinarian. (2) Swine—(i) Amount. 3 mg per pound lococcus spp., and Streptococcus spp. and of body weight by intramuscular injec- acute necrotic pododermatitis (foot tion, once or twice daily, for up to 3 rot) due to Fusobacterium necrophorum. days. (iii) Limitations. Treated animals (ii) Indications for use. Treatment of must not be slaughtered for food dur- bacterial enteritis (colibacillosis) ing treatment and for 25 days after the caused by E. coli and bacterial pneu- last treatment. Milk from treated cows monia caused by Pasteurella spp. sus- must not be used for human consump- ceptible to ampicillin. tion during treatment or for 96 hours (8 (iii) Limitations. Treated animals milkings) after last treatment. Federal must not be slaughtered for food use law restricts this drug to use by or on during treatment or for 15 days after the order of a licensed veterinarian. the last treatment. Federal law re- [79 FR 16183, Mar. 25, 2014] stricts this drug to use by or on the order of a licensed veterinarian. § 522.90 Ampicillin injectable dosage (3) Dogs—(i) Amount—(A) 3 to 6 mg forms. per pound of body weight by intramuscular injection, once or twice [79 FR 16183, Mar. 25, 2014] daily. Usual treatment is 3 to 5 days.

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(B) 3 to 5 mg of ampicillin per pound piratory tract infections, urinary tract of body weight, once a day for up to 4 infections, gastrointestinal infections, days. skin infections, soft tissue infections, (ii) Indications for use—(A) Treatment and postsurgical infections. of respiratory tract infections due to E. (iii) Limitations. Federal law restricts coli, Pseudomonas spp., Proteus spp., this drug to use by or on the order of a Staphylococcus spp., and Streptococcus licensed veterinarian. spp.; tonsillitis due to E. coli, (2) Cattle—(i) Amount. 2 to 5 mg/lb of Pseudomonas spp., Streptococcus spp., body weight once daily by and Staphylococcus spp.; generalized in- intramuscular injection. fections (septicemia) associated with (ii) For treatment abscesses, lacerations, and wounds due Indications for use. to Staphylococcus spp. and Streptococcus of respiratory tract infections caused spp. by organisms susceptible to ampicillin, (B) Treatment of bacterial infections bacterial pneumonia (shipping fever, of the upper respiratory tract (tonsil- calf pneumonia, and bovine pneu- litis) due to Streptococcus spp., Staphy- monia) caused by Aerobacter spp., lococcus spp., E. coli, Proteus spp., and Klebsiella spp., Staphylococcus spp., Pasteurella spp., and soft tissue infec- Streptococcus spp., Pasteurella multocida, tions (abscesses, lacerations, and and Escherichia coli. wounds) due to Staphylococcus spp., (iii) Limitations. Do not treat cattle Streptococcus spp., and E. coli, when for more than 7 days. Milk from treat- caused by susceptible organisms. ed cows must not be used for food dur- (iii) Limitations. Federal law restricts ing treatment and for 48 hours (4 this drug to use by or on the order of a milkings) after the last treatment. licensed veterinarian. Cattle must not be slaughtered for food (4) Cats—(i) Amount. 5 to 10 mg per during treatment and for 144 hours (6 pound of body weight by intramuscular days) after the last treatment. Federal or subcutaneous injection, once or law restricts this drug to use by or on twice daily. Usual treatment is 3 to 5 the order of a licensed veterinarian. days. (ii) Indications for use. Treatment of [57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept. generalized infections (septicemia) as- 15, 1992; 58 FR 18304, Apr. 8, 1993; 63 FR 41420, Aug. 4, 1998; 75 FR 10167, Mar. 5, 2010; 76 FR sociated with abscesses, lacerations, 17338, Mar. 29, 2011; 76 FR 53051, Aug. 25, 2011; and wounds due to Staphylococcus spp., 82 FR 21690, May 10, 2017] Streptococcus spp., and Pasteurella spp. (iii) Limitations. Federal law restricts § 522.90c Ampicillin sodium. this drug to use by or on the order of a licensed veterinarian. (a) Specifications. Each milliliter of aqueous solution constituted from am- [79 FR 16183, Mar. 25, 2014] picillin sodium powder contains 300 milligrams (mg) ampicillin equiva- § 522.90b Ampicillin trihydrate powder for injection. lents. (b) Sponsors. See Nos. 010515 and (a) Specifications. Each milliliter of 054771 in § 510.600(c) of this chapter. aqueous suspension constituted from (c) —(1) ampicillin trihydrate powder contains Conditions of use in horses 200, 250, or 400 milligrams (mg) ampi- Amount: 3 mg per pound of body weight cillin equivalents. twice daily by intravenous or (b) Sponsors. See Nos. 000010 and intramuscular injection. 010515 in § 510.600(c) of this chapter. (2) Indications for use. For the treat- (c) Related tolerances. See § 556.40 of ment of respiratory tract infections this chapter. (pneumonia and strangles) due to (d) Conditions of use—(1) Dogs and Staphylococcus spp., Streptococcus spp. cats—(i) Amount. 3 mg/pound (lb) of (including S. equi), Escherichia coli, and body weight twice daily by subcuta- Proteus mirabilis, and skin and soft tis- neous or intramuscular injection. sue infections (abscesses and wounds) (ii) Indications for use. For treatment due to Staphylococcus spp., Streptococcus of strains of organisms susceptible to spp., E. coli, and P. mirabilis, when ampicillin and associated with res- caused by susceptible organisms.

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(3) Limitations. Do not use in horses (2) Dosage. 2.2 mg per kilogram (1 mg intended for human consumption. Fed- per pound) by deep intramuscular in- eral law restricts this drug to use by or jection. on the order of a licensed veterinarian. (3) Limitations. Federal law restricts [72 FR 45158, Aug. 13, 2007, as amended at 79 this drug to use by or on the order of a FR 16184, Mar. 25, 2014] licensed veterinarian.

§ 522.144 Arsenamide. [74 FR 65689, Dec. 11, 2009, as amended at 77 FR 46613, Aug. 6, 2012; 81 FR 48702, July 26, (a) Specifications. Each milliliter of 2016] solution contains 10.0 milligrams arsenamide sodium. § 522.161 Betamethasone. (b) Sponsor. See No. 050604 in (a) Specifications. Each milliliter of § 510.600(c) of this chapter. suspension contains: (c) Conditions of use in dogs—(1) (1) Betamethasone acetate equivalent Amount. Administer 0.1 milliliter (mL) per pound of body weight (1.0 mL for to 10.8 milligrams (mg) betamethasone every 10 pounds) by intravenous injec- and betamethasone disodium phos- tion twice a day for 2 days. phate equivalent to 3 mg of (2) Indications for use. For the treat- betamethasone. ment and prevention of canine heart- (2) Betamethasone dipropionate worm disease caused by Dirofilaria equivalent to 5 mg betamethasone and immitis. betamethasone sodium phosphate (3) Limitations. Federal law restricts equivalent to 2 mg of betamethasone. this drug to use by or on the order of a (b) Sponsor. See sponsor numbers in licensed veterinarian. § 510.600(c) of this chapter: (1) No. 000061 for product described in [79 FR 16184, Mar. 25, 2014] paragraph (a)(1) of this section for use § 522.147 Atipamezole. as in paragraphs (c)(1), (c)(2)(i), (c)(2)(ii)(A), and (c)(2)(iii) of this sec- (a) Specifications. Each milliliter of tion. solution contains 5.0 milligrams atipamezole hydrochloride. (2) No. 000061 for product described in (b) Sponsor. See No. 052483 in paragraph (a)(2) of this section for use § 510.600(c) of this chapter. as in paragraphs (c)(1), (c)(2)(i), (c) Conditions of use in dogs—(1) (c)(2)(ii)(B), and (c)(2)(iii) of this sec- Amount. Inject intramuscularly the tion. same volume as that of (c) Conditions of use—(1) Dogs—(i) dexmedetomidine or medetomidine Amount. Administer by intramuscular used. injection 0.25 to 0.5 milliliter (mL) per (2) Indications for use. For reversal of 20 pounds of body weight, depending on the sedative and analgesic effects of the severity of the condition. Fre- dexmedetomidine hydrochloride or quency of dosage depends on recurrence medetomidine hydrochloride. of pruritic symptoms. Dosage may be (3) Limitations. Federal law restricts repeated every 3 weeks or when symp- this drug to use by or on the order of a toms recur, not to exceed a total of licensed veterinarian. four injections. (ii) Indications for use. As an aid in [61 FR 48830, Sept. 17, 1996, as amended at 64 FR 71640, Dec. 22, 1999; 72 FR 264, Jan. 4, 2007] the control of pruritus associated with dermatoses. § 522.150 Azaperone. (iii) Limitations. Federal law restricts (a) Specifications. Each milliliter of this drug to use by or on the order of a solution contains 40 milligrams (mg) licensed veterinarian. azaperone. (2) Horses—(i) Amount. Administer 2.5 (b) Sponsor. See No. 058198 in to 5 mL by intra-articular injection. § 510.600(c) of this chapter. (ii) Indications for use—(A) For the (c) Conditions of use—(1) Indications treatment of various inflammatory for use. For control of aggressiveness joint conditions; for example, acute when mixing or regrouping weanling or and traumatic lameness involving the feeder pigs weighing up to 80 pounds. carpel and fetlock joints.

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(B) As an aid in the control of inflam- dystocia, fetal death, retained pla- mation associated with various centa, and metritis. arthropathies. (4) Restrictions. Federal law restricts (iii) Limitations. Do not use in horses this drug to use by or on the order of a intended for human consumption. Fed- licensed veterinarian. eral law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13858, Mar. 27, 1975, as amended at 41 FR 27316, July 2, 1976; 52 FR 7832, Mar. 13, [79 FR 16184, Mar. 25, 2014] 1987]

§ 522.163 Betamethasone dipropionate § 522.167 Betamethasone sodium phos- and betamethasone sodium phosphate and betamethasone acetate. phate aqueous suspension. (a) Specifications. Each milliliter (a) Specifications. Betamethasone (mL) of suspension contains 6 milli- dipropionate and betamethasone so- grams (mg) betamethasone (3.15 mg dium phosphate aqueous suspension is betamethasone sodium phosphate and a sterile aqueous suspension. Each mil- 2.85 mg betamethasone acetate). liliter of the suspension contains the (b) Sponsor. See No. 010797 in equivalent of 5 milligrams of § 510.600(c) of this chapter. betamethasone as betamethasone dipropionate and 2 milligrams of (c) Conditions of use in horses—(1) betamethasone as betamethasone so- Amount. Administer 1.5 mL (9 mg total dium phosphate. betamethasone) per joint by intra-ar- (b) Sponsor. See No. 000061 in ticular injection. May be administered § 510.600(c) of this chapter. concurrently in up to two joints per (c) Conditions of use—(1) Dogs. (i) It is horse. used as an aid in the control of pru- (2) Indications for use. For the control ritus associated with dermatoses. of pain and inflammation associated (ii) It is administered by with osteoarthritis in horses. intramuscular injection at a dosage of (3) Limitations. Do not use in horses 0.25 to 0.5 milliliter per 20 pounds of intended for human consumption. Fed- body weight, depending on the severity eral law restricts this drug to use by or of the condition. Frequency of dosage on the order of a licensed veterinarian. depends on recurrence of pruritic symptoms. Dosage may be repeated [80 FR 18776, Apr. 8, 2015] every 3 weeks or when symptoms recur, § 522.204 Boldenone. not to exceed a total of 4 injections. (2) Horses. (i) It is used as an aid in (a) Specifications. Each milliliter of the control of inflammation associated solution contains 25 or 50 milligrams with various arthropathies. (mg) boldenone undecylenate. (ii) It is administered aseptically by (b) Sponsor. See No. 054771 in intraarticular injection at a dosage of § 510.600(c) of this chapter. 2.5 to 5 milliliters per joint, depending (c) Conditions of use in horses—(1) on the severity of the condition and Amount. 0.5 mg per pound body weight the joint size. Dosage may be repeated by intramuscular injection. Treatment upon recurrence of clinical signs. Injec- may be repeated at 3-week intervals. tion into the joint cavity should be (2) Indications for use. As an aid for preceded by withdrawal of synovial treating debilitated horses when an im- fluid. provement in weight, hair coat, or gen- (iii) Not for use in horses intended for eral physical condition is desired. food. (3) Limitations. Do not administer to (3) Clinical and experimental data. It horses intended for human consump- has been demonstrated that tion. Federal law restricts this drug to corticosteroids administered orally or parenterally to animals may induce use by or on the order of a licensed vet- the first stage of parturition when ad- erinarian. ministered during the last trimester of [70 FR 70998, Nov. 25, 2005, as amended at 79 pregnancy and may precipitate pre- FR 16184, Mar. 25, 2014] mature parturition followed by

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§ 522.224 Bupivacaine. (Trichuris vulpis), and the hookworm (a) Specifications. Each milliliter (Ancylostoma caninum). (mL) of liposomal suspension contains (3) Limitations. Federal law restricts 13.3 milligrams (mg) bupivacaine. this drug to use by or on the order of a (b) Sponsor. See No. 086026 in licensed veterinarian. § 510.600(c) of this chapter. [79 FR 16184, Mar. 25, 2014] (c) Conditions of use in dogs—(1) Amount. Administer 5.3 mg/kg (0.4 mL/ § 522.246 Butorphanol. kg) by infiltration injection into the (a) Specifications. Each milliliter of tissue layers at the time of incisional solution contains butorphanol (as closure. butorphanol tartrate) in the following (2) Indications for use. For single-dose amounts: infiltration into the surgical site to (1) 0.5 milligrams (mg); provide local postoperative analgesia (2) 2 mg; or for cranial cruciate ligament surgery (3) 10 mg in dogs. (b) Sponsors. See sponsors in (3) Limitations. Federal law restricts § 510.600(c) of this chapter as follows: this drug to use by or on the order of a licensed veterinarian. (1) No. 054771 for use of the product described in paragraph (a)(1) as in para- [81 FR 67151, Sept. 30, 2016] graph (d)(1) of this section; for use of the product described in paragraph § 522.230 Buprenorphine. (a)(2) as in paragraph (d)(2) of this sec- (a) Specifications. Each milliliter of tion; and for use of the product de- solution contains 1.8 milligrams (mg) scribed in paragraph (a)(3) as in para- buprenorphine. graph (d)(3) of this section. (b) Sponsor. See No. 054771 in (2) No. 000859 for use of the product § 510.600(c) of this chapter. described in paragraph (a)(2) as in para- (c) Conditions of use in cats—(1) graph (d)(2) of this section. Amount. Administer 0.24 mg per kilo- (3) Nos. 000061, 000859, and 059399 for gram (0.11 mg per pound) by subcuta- use of the product described in para- neous injection once daily, for up to 3 graph (a)(3) as in paragraph (d)(3) of days. Administer the first dose ap- this section. proximately 1 hour prior to surgery. (c) Special considerations. Federal law (2) Indications for use. For the control restricts this drug to use by or on the of postoperative pain associated with order of a licensed veterinarian. surgical procedures in cats. (d) Conditions of use—(1) Dogs—(i) (3) Limitations. Federal law restricts Amount. Administer 0.025 mg per pound this drug to use by or on the order of a of body weight by subcutaneous injec- licensed veterinarian. tion at intervals of 6 to 12 hours, as re- [79 FR 53136, Sept. 8, 2014, as amended at 80 quired. If necessary, increase dose to a FR 18776, Apr. 8, 2015] maximum of 0.05 mg per pound of body weight. Treatment should not nor- § 522.234 Butamisole. mally be required for longer than 7 (a) Specifications. Each milliliter of days. solution contains 11 milligrams (mg) (ii) Indications for use. For the relief butamisole hydrochloride. of chronic nonproductive cough associ- (b) Sponsors. See Nos. 000859 and ated with tracheo-bronchitis, tra- 054771 in § 510.600(c) of this chapter. cheitis, tonsillitis, laryngitis, and (c) Conditions of use in dogs—(1) pharyngitis associated with inflam- Amount. Administer 0.1 mg per pound matory conditions of the upper res- of body weight by subcutaneous injec- piratory tract. tion. In problem cases, retreatment for (2) Cats—(i) Amount. Administer 0.2 whipworms may be necessary in ap- mg per pound of body weight by sub- proximately 3 months. For hookworms, cutaneous injection. Dose may be re- a second injection should be given 21 peated up to 4 times per day. Do not days after the initial treatment. treat for more than 2 days. (2) Indications for use. For the treat- (ii) Indications for use. For the relief ment of infections with whipworms of pain in cats caused by major or

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minor trauma, or pain associated with veterinarian. The licensed veterinarian surgical procedures. shall be a veterinarian engaged in zoo (3) Horses—(i) Amount. Administer and exotic animal practice, wildlife 0.05 mg per pound of body weight by in- management programs, or research. travenous injection. Dose may be re- [79 FR 16185, Mar. 25, 2014] peated within 3 to 4 hours. Treatment should not exceed 48 hours. EFFECTIVE DATE NOTE: At 83 FR 13635, Mar. (ii) Indications for use. For the relief 30, 2018, § 522.300 was removed, effective Apr. of pain associated with colic and 9, 2018. postpartum pain in adult horses and § 522.304 Carprofen. yearlings. (iii) Limitations. Do not use in horses (a) Specifications. Each milliliter of intended for human consumption. solution contains 50 milligrams (mg) carprofen. [72 FR 27957, May 18, 2007, as amended at 73 (b) Sponsors. See Nos. 016729, 026637, FR 31358, June 2, 2008; 74 FR 61516, Nov. 25, 054771, and 055529 in § 510.600(c) of this 2009; 75 FR 22524, Apr. 29, 2010; 77 FR 60302, chapter. Oct. 3, 2012; 78 FR 17597, Mar. 22, 2013; 79 FR 16184, Mar. 25, 2014; 79 FR 74020, Dec. 15, 2014; (c) [Reserved] 80 FR 13229, Mar. 13, 2015] (d) Conditions of use in dogs—(1) Amount. 2 mg/lb (4.4 mg/kg) body § 522.275 N-Butylscopolammonium. weight once daily or 1 mg/lb (2.2 mg/kg) (a) Specifications. Each milliliter of twice daily, by subcutaneous injection. solution contains 20 milligrams (mg) For the control of postoperative pain, N-butylscopolammonium bromide. administer approximately 2 hours be- (b) Sponsor. See No. 000010 in fore the procedure. § 510.600(c) of this chapter. (2) Conditions of use. For the relief of (c) Conditions of use in horses—(1) pain and inflammation associated with Amount. 0.3 mg per kilogram of body osteoarthritis and for the control of weight (0.14 mg per pound) slowly in- postoperative pain associated with soft travenously. tissue and orthopedic surgeries. (2) Indications for use. For the control (3) Limitations. Federal law restricts of abdominal pain (colic) associated this drug to use by or on the order of a with spasmodic colic, flatulent colic, licensed veterinarian. and simple impactions. [68 FR 26205, May 15, 2003, as amended at 68 (3) Limitations. Federal law restricts FR 34796, June 11, 2003; 68 FR 49351, Aug. 18, this drug to use by or on the order of a 2003. Redesignated at 73 FR 29685, May 22, licensed veterinarian. 2008, as amended at 79 FR 74020, Dec. 15, 2014; 82 FR 43484, Sept. 18, 2017] [69 FR 35512, June 25, 2004] § 522.311 Cefovecin. § 522.300 Carfentanil. (a) Specifications. Each milliliter of (a) Specifications. Each milliliter of constituted solution contains 80 milli- solution contains 3 milligrams (mg) grams (mg) cefovecin as the sodium carfentanil citrate. salt. (b) Sponsor. See No. 053923 in (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Ad- (c) Special considerations. Federal law minister 5 to 20 micrograms per kilo- restricts this drug to use by or on the gram (0.005 to 0.020 mg per kilogram) of order of a licensed veterinarian. body weight into large muscle of the (d) Conditions of use—(1) Dogs—(i) neck, shoulder, back, or hindquarter. Amount. Administer 3.6 mg/pound (lb) (8 (2) Indications for use. For immo- mg/kilograms (kg)) body weight as a bilizing free ranging and confined single subcutaneous injection. A sec- members of the family Cervidae (deer, ond subcutaneous injection of 3.6 mg/lb elk, and moose). (8 mg/kg) may be administered if re- (3) Limitations. Do not use in domes- sponse to therapy is not complete. tic animals intended for food. Do not (ii) Indications for use. For the treat- use 30 days before or during hunting ment of skin infections (secondary su- season. Federal law restricts this drug perficial pyoderma, abscesses, and to use by or on the order of a licensed wounds) in dogs caused by susceptible

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strains of Staphylococcus intermedius (i) Amount. For subcutaneous (SC) in- and Streptococcus canis (Group G). jection in the posterior aspect of the (2) Cats—(i) Amount. Administer 3.6 ear where it attaches to the head (base mg/lb (8 mg/kg) body weight as a sin- of the ear) in lactating dairy cattle. gle, one-time subcutaneous injection. For SC injection in the middle third of (ii) Indications for use. For the treat- the posterior aspect of the ear or in the ment of skin infections (wounds and base of the ear in beef and non-lac- abscesses) in cats caused by susceptible tating dairy cattle. strains of Pasteurella multocida. (A) Single-dose regimen: 6.6 mg [73 FR 29685, May 22, 2008, as amended at 79 ceftiofur equivalents per kg of body FR 16185, Mar. 25, 2014] weight as a single injection. (B) Two-dose regimen: 6.6 mg § 522.313 Ceftiofur injectable dosage ceftiofur equivalents per kg of body forms. weight given as two injections in the base of the ear approximately 72 hours § 522.313a Ceftiofur crystalline free acid. apart. (ii) Indications for use—(A) Single- (a) Specifications. The product is a dose regimen: For the treatment of bo- suspension of ceftiofur crystalline free vine respiratory disease (BRD, shipping acid. fever, pneumonia) associated with (1) Each milliliter (mL) contains 100 Mannheimia haemolytica, Pasteurella milligrams (mg) ceftiofur equivalents. multocida, and Histophilus somni in beef, (2) Each mL contains 200 mg ceftiofur non-lactating dairy, and lactating equivalents. dairy cattle. For the control of res- (b) Sponsor. See No. 054771 in piratory disease in beef and non-lac- § 510.600(c) of this chapter. tating dairy cattle which are at high (c) Related tolerances. See § 556.113 of risk of developing BRD associated with this chapter. M. haemolytica, P. multocida, and H. (d) Conditions of use—(1) Swine. The somni. For the treatment of bovine foot formulation described in paragraph (a)(1) of this section is used as follows: rot (interdigital necrobacillosis) asso- (i) Amount. 5.0 mg CE per kilogram ciated with Fusobacterium necrophorum (kg) of body weight by intramuscular and Porphyromonas levii in beef, non- injection in the postauricular region of lactating dairy, and lactating dairy the neck. cattle. (ii) Indications for use. For the treat- (B) Two-dose regimen: For the treatment of swine respiratory disease ment of acute metritis (0-to 10-days (SRD) associated with Actinobacillus postpartum) associated with bacterial pleuropneumoniae, Pasteurella multocida, organisms susceptible to ceftiofur in Haemophilus parasuis, and Streptococcus lactating dairy cattle. suis. For the control of SRD associated (iii) Limitations. Following label use with A. pleuropneumoniae, P. multocida, as either a single-dose or 2-dose regi- H. parasuis, and S. suis in groups of pigs men, a 13-day pre-slaughter withdrawal where SRD has been diagnosed. period is required after the last treat- (iii) Limitations. Following label use ment. A withdrawal period has not as a single treatment, a 14-day pre- been established in preruminating slaughter withdrawal period is re- calves. Do not use in calves to be proc- quired. Federal law restricts this drug essed for veal. Federal law restricts to use by or on the order of a licensed this drug to use by or on the order of a veterinarian. Federal law prohibits licensed veterinarian. Federal law pro- extra-label use of this drug in swine for hibits extra-label use of this drug in disease prevention purposes; at unap- cattle for disease prevention purposes; proved doses, frequencies, durations, or at unapproved doses, frequencies, dura- routes of administration; and in unap- tions, or routes of administration; and proved, major food-producing species/ in unapproved, major food-producing production classes. species/production classes. (2) Cattle. The formulation described (3) Horses. The formulation described in paragraph (a)(2) of this section is in paragraph (a)(2) of this section is used as follows: used as follows:

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(i) Amount. Two intramuscular injec- (A) For bovine respiratory disease tions, 4 days apart, at a dose of 3.0 mg/ and acute bovine interdigital lb (6.6 mg/kg) body weight. necrobacillosis: 1.1 to 2.2 mg/kg of body (ii) Indications for use. For the treat- weight at 24-hour intervals for 3 to 5 ment of lower respiratory tract infec- consecutive days. tions in horses caused by susceptible (B) For bovine respiratory disease: 2.2 strains of Streptococcus equi ssp. mg/kg of body weight administered zooepidemicus. twice at a 48 hour interval. (iii) Limitations. Do not use in horses (C) For acute metritis: 2.2 mg/kg of intended for human consumption. Fed- body weight at 24-hour intervals for 5 eral law restricts this drug to use by or consecutive days. on the order of a licensed veterinarian. (ii) Indications for use. For treatment of bovine respiratory disease (BRD, [68 FR 60296, Oct. 22, 2003, as amended at 69 FR 43892, July 23, 2004. Redesignated and shipping fever, pneumonia) associated amended at 71 FR 39546, July 13, 2006; 73 FR with Mannheimia haemolytica, P. 58872, Oct. 8, 2008; 75 FR 4692, Jan. 29, 2010; 75 multocida, and Histophilus somni; acute FR 62468, Oct. 12, 2010; 77 FR 26162, May 3, bovine interdigital necrobacillosis 2012; 79 FR 16185, Mar. 25, 2014; 79 FR 37620, (foot rot, pododermatitis) associated July 2, 2014] with Fusobacterium necrophorum and Bacteroides melaninogenicus; and acute § 522.313b Ceftiofur hydrochloride. metritis (0 to 14 days post-partum) as- (a) Specifications. Each milliliter of sociated with bacteria susceptible to ceftiofur hydrochloride suspension con- ceftiofur. tains 50 milligrams (mg) ceftiofur (iii) Limitations. Treated cattle must equivalents. not be slaughtered for 4 days following (b) Sponsor. See No. 054771 in the last treatment. A withdrawal pe- § 510.600(c) of this chapter. riod has not been established in (c) Related tolerances. See § 556.113 of preruminating calves. Do not use in this chapter. calves to be processed for veal. (d) Special considerations. Federal law [61 FR 29479, June 11, 1996, as amended at 63 restricts this drug to use by or on the FR 53578, Oct. 6, 1998; 67 FR 45901, July 11, order of a licensed veterinarian. Fed- 2002; 69 FR 47362, Aug. 5, 2004. Redesignated eral law prohibits extra-label use of and amended at 71 FR 39544, July 13, 2006; 73 this drug in cattle and swine for dis- FR 45612, Aug. 6, 2008; 76 FR 17338, Mar. 29, ease prevention purposes; at unap- 2011; 78 FR 66264, Nov. 5, 2013] proved doses, frequencies, durations, or routes of administration; and in unap- § 522.313c Ceftiofur sodium. proved major food-producing species/ (a) Specifications. Each milliliter of production classes. aqueous solution constituted from (e) Conditions of use—(1) Swine—(i) ceftiofur sodium powder contains 50 Amount. 3 to 5 mg per kilogram (/kg) of milligrams (mg) ceftiofur equivalents. body weight by intramuscular injec- (b) Sponsors. See Nos. 054771 and tion. Treatment should be repeated at 068330 in § 510.600(c) of this chapter. 24-hour intervals for a total of 3 con- (c) Related tolerances. See § 556.113 of secutive days. this chapter. (ii) Indications for use. For treatment (d) Special considerations. Federal law and control of swine bacterial res- restricts this drug to use by or on the piratory disease (swine bacterial pneu- order of a licensed veterinarian. Fed- monia) associated with Actinobacillus eral law prohibits extra-label use of pleuropneumoniae, Pasteurella multocida, this drug in cattle, swine, chickens, Salmonella Choleraesuis, and Strepto- and turkeys for disease prevention pur- coccus suis. poses; at unapproved doses, fre- (iii) Limitations. Treated swine must quencies, durations, or routes of ad- not be slaughtered for 4 days following ministration; and in unapproved major the last treatment. food-producing species/production (2) Cattle—(i) Amount. Administer by classes. subcutaneous or intramuscular injec- (e) Conditions of use—(1) Swine—(i) tion as follows: Amount. 3 to 5 mg per kilogram (/kg)

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body weight by intramuscular injec- erichia coli organisms susceptible to tion for 3 consecutive days. ceftiofur in day-old chicks. (ii) Indications for use. For treatment (6) Turkeys—(i) Amount. 0.17 to 0.5 mg and control of swine bacterial res- as a single subcutaneous injection in piratory disease (swine bacterial pneu- the neck. monia) associated with Actinobacillus (ii) Indications for use. For control of pleuropneumoniae, Pasteurella multocida, early mortality associated with E. coli Salmonella choleraesuis, and Strepto- organisms susceptible to ceftiofur in coccus suis. day-old poults. (iii) Limitations. Treated pigs must (7) Horses—(i) Amount. 2.2 to 4.4 mg/kg not be slaughtered for 4 days following (1.0 to 2.0 mg/lb) body weight by the last treatment. intramuscular injection. Treatment (2) Cattle—(i) Amount. 0.5 to 1.0 mg/lb should be repeated every 24 hours, con- body weight by intramuscular or sub- tinued for 48 hours after clinical signs cutaneous injection for 3 days. Addi- have disappeared, and should not ex- tional treatments may be given on ceed 10 days. A maximum of 10 mL days 4 and 5 for animals which do not should be administered per injection show satisfactory response. site. (ii) Indications for use. For treatment (ii) Indications for use. For treatment of respiratory infections in horses asso- of bovine respiratory disease (shipping ciated with Streptococcus zooepidemicus. fever, pneumonia) associated with (iii) Limitations. Do not use in horses Mannheimia haemolytica, Pasteurella intended for human consumption. multocida, and Histophilus somni. Also, (8) Dogs—(i) Amount. 1.0 mg/lb (2.2 mg/ for the treatment of acute bovine kg) body weight by subcutaneous injec- interdigital necrobacillosis (foot rot, tion. Treatment should be repeated at pododermatitis) associated with 24-hour intervals for 5 to 14 days. Fusobacterium necrophorum and (ii) Indications for use. For treatment Bacteroides melaninogenicus. of canine urinary tract infections asso- (iii) Limitations. Treated cattle must ciated with E. coli and Proteus mirabilis. not be slaughtered for 4 days following the last treatment. [53 FR 5369, Feb. 24, 1988, as amended at 55 (3) Sheep—(i) Amount. 0.5 to 1.0 mg/lb FR 13768, Apr. 12, 1990; 56 FR 12119, Mar. 22, 1991; 57 FR 41862, Sept. 14, 1992; 59 FR 41666, body weight by intramuscular injec- Aug. 15, 1994; 59 FR 54518, Nov. 1, 1994; 60 FR tion for 3 days. Additional treatments 51719, Oct. 3, 1995; 61 FR 35130, July 5, 1996; 61 may be given on days 4 and 5 for ani- FR 66583, Dec. 18, 1996; 66 FR 21283, Apr. 30, mals which do not show satisfactory 2001; 66 FR 32540, June 15, 2001; 69 FR 47362, response. Aug. 5, 2004. Redesignated and amended at 71 (ii) Indications for use. For treatment FR 39544, July 13, 2006; 74 FR 34236, July 15, of sheep respiratory disease (sheep 2009; 77 FR 29218, May 17, 2012; 79 FR 16185, Mar. 25, 2014; 79 FR 21127, Apr. 15, 2014; 82 FR pneumonia) associated with 12169, Mar. 1, 2017] Mannheimia haemolytica and Pasteurella multocida. § 522.380 Chloral hydrate, pento- (4) Goats—(i) Amount. 0.5 to 1.0 mg/lb barbital, and magnesium sulfate. body weight by intramuscular injec- (a) Specifications. Each milliliter of tion for 3 days. Additional treatments solution contains 42.5 milligrams (mg) may be given on days 4 and 5 for ani- of chloral hydrate, 8.86 mg of pento- mals which do not show satisfactory barbital, and 21.2 mg of magnesium sul- response. fate. (ii) Indications for use. For treatment (b) Sponsor. See No. 054771 in of caprine respiratory disease (goat § 510.600(c) of this chapter. pneumonia) associated with (c) Conditions of use—(1) Amount. For Mannheimia haemolytica and Pasteurella general anesthesia: Administer 20 to 50 multocida. milliliters per 100 pounds of body (5) Chickens—(i) Amount. 0.08 to 0.20 weight by intravenous injection until mg as a single subcutaneous injection the desired effect is produced. Cattle in the neck. usually require a lower dosage on the (ii) Indications for use. For control of basis of body weight. As a sedative-re- early mortality associated with Esch- laxant: Administer at a level of one-

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fourth to one-half of the anesthetic § 522.460 Cloprostenol. dosage level. (a) Specifications. Each milliliter of (2) Indications for use. For general an- solution contains cloprostenol sodium esthesia and as a sedative-relaxant in equivalent to: cattle and horses. (1) 125 micrograms (μg) of (3) Limitations. Federal law restricts cloprostenol; or this drug to use by or on the order of a (2) 250 μg of cloprostenol. licensed veterinarian. (b) Sponsors. See sponsors in [79 FR 16185, Mar. 25, 2014] § 510.600(c) of this chapter. (1) No. 000061 for use of product de- § 522.390 Chloramphenicol. scribed in paragraph (a)(1) of this sec- (a) Specifications. Each milliliter of tion as in paragraphs (c)(1)(i) and (c)(2) solution contains 100 milligrams of of this section. chloramphenicol. (2) Nos. 000061 and 068504 for use of (b) Sponsor. See Nos. 054771 and 069043 product described in paragraph (a)(2) as in § 510.600(c) of this chapter. in paragraphs (c)(1)(ii), (c)(1)(iii), and (c) Conditions of use. Dogs—(1) (c)(2) of this section. Amount. 5 to 15 milligrams per pound of (c) Conditions of use in cattle—(1) body weight, intramuscularly or intra- Amount and indications for use—(i) Ad- venously, every 6 hours. In severe in- minister 375 μg by intramuscular injec- fections, use 4 to 6 hour treatment in- tion to induce abortion in pregnant tervals the first day. If no response is feedlot heifers from 1 week after mat- obtained in 3 to 5 days, discontinue use ing until 41⁄2 months of gestation. and reevaluate diagnosis. (ii) Administer 500 μg by (2) Indications for use. Treatment of intramuscular injection for termi- infections of the respiratory tract, the nating unwanted pregnancies from urinary tract, and enteritis and tonsil- mismatings from 1 week after mating litis caused by organisms susceptible until 5 months after conception; for to chloramphenicol. treating unobserved (nondetected) (3) Limitations. Federal law restricts estrus, mummified fetus, and luteal this drug to use by or on the order of a cysts; and for the treatment of licensed veterinarian. Federal law pro- pyometra. hibits the extralabel use of this drug in (iii) Administer 500 μg by food-producing animals. intramuscular injection as a single in- [57 FR 37331, Aug. 18, 1992, as amended at 65 jection regimen or double injection FR 45877, July 26, 2000; 78 FR 17597, Mar. 22, regimen with a second injection 11 days 2013; 79 FR 16185, Mar. 25, 2014; 81 FR 17608, after the first, for scheduling estrus Mar. 30, 2016] and ovulation to control the time at which cycling cows or heifers can be § 522.454 Clodronate. bred. (a) Specifications. Each milliliter of (2) Limitations. Federal law restricts solution contains 60 milligrams (mg) this drug to use by or on the order of a clodronate disodium. licensed veterinarian. (b) Sponsor. See No. 043264 in [79 FR 16185, Mar. 25, 2014] § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) § 522.468 Colistimethate sodium pow- Amount. Administer 1.8 mg per kilo- der for injection. gram of body weight by intramuscular (a) Specifications. Each vial contains injection up to a maximum dose of 900 colistimethate sodium equivalent to 10 mg per horse. grams colistin activity and mannitol (2) Indications for use. For the control to be reconstituted with 62.5 milliliters of clinical signs associated with navic- sterile saline or sterile water for injec- ular syndrome. tion. The resulting solution contains (3) Limitations. Do not use in horses colistimethate sodium equivalent to intended for human consumption. Fed- 133 milligrams per milliliter colistin eral law restricts this drug to use by or activity. on the order of a licensed veterinarian. (b) Sponsor. See 054771 in § 510.600(c) of [79 FR 37620, July 2, 2014] this chapter.

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(c) [Reserved] cortex where there is a general defi- (d) Conditions of use. (1) 1- to 3-day- ciency of ACTH. old chickens. (iii) Limitations. Federal law restricts (i) Dosage. 0.2 milligram colistin ac- this drug to use by or on the order of a tivity per chicken. licensed veterinarian. (ii) Indications for use. Control of early mortality associated with Esch- [79 FR 16185, Mar. 25, 2014] erichia coli organisms susceptible to § 522.518 Cupric glycinate injection. colistin. (iii) Limitations. For subcutaneous in- (a) Specifications. Each milliliter jection in the neck of 1- to 3-day-old (mL) of sterile aqueous suspension con- chickens. Not for use in laying hens tains 200 milligrams of cupric glycinate producing eggs for human consump- (equivalent to 60 milligrams of copper). tion. Do not use in turkeys. Federal (b) Sponsor. See No. 049185 in law restricts this drug to use by or on § 510.600(c) of this chapter. the order of a licensed veterinarian. (c) Conditions of use—(1) Amount. 200 (2) [Reserved] milligrams (1 mL) for calves 300 pounds and under; 400 milligrams (2 mL) for [63 FR 13123, Mar. 18, 1998, as amended at 79 calves over 300 pounds and adult cattle. FR 16185, Mar. 25, 2014] (2) Indications for use. For beef calves § 522.480 Corticotropin. and beef cattle for the prevention of copper deficiency, or when labeled for (a) Specifications. Each milliliter of veterinary prescription use, for the aqueous solution contains 40 or 80 prevention and/or treatment of copper U.S.P. (I.U.) units of repository deficiency alone or in association with corticotropin. molybdenum toxicity. (b) Sponsor. See sponsors in (3) Limitations. For subcutaneous use § 510.600(c) of this chapter. only; repeat dose in 3 months in young (1) No. 061623 for use as in paragraphs calves, in 6 months in cattle; dis- (c)(1) and (2) of this section. continue use 30 days before treated ani- (2) No. 026637 for use as in paragraph mals are slaughtered for food use; Fed- (c)(2) and (3) of this section. eral law restricts this drug to use by or (c) Conditions of use—(1) Dogs—(i) on the order of a licensed veterinarian. Amount. Administer one unit per pound of body weight by intramuscular injec- [46 FR 20159, Apr. 3, 1981, as amended at 52 tion. FR 7832, Mar. 13, 1987; 62 FR 28630, May 27, (ii) Indications for use. As a diagnostic 1997] aid to test for adrenal dysfunction. (iii) Limitations. Federal law restricts § 522.522 Danofloxacin. this drug to use by or on the order of a (a) Specifications. Each milliliter of licensed veterinarian. solution contains 180 milligrams (mg) (2) Dogs and cats—(i) Amount. Admin- danofloxacin as the mesylate salt. ister one unit per pound of body weight (b) Sponsor. See No. 054771 in by intramuscular or subcutaneous in- § 510.600(c) of this chapter. jection, to be repeated as indicated. (c) Related tolerances. See § 556.169 of (ii) Indications for use. For stimula- this chapter. tion of the adrenal cortex where there (d) Conditions of use in cattle—(1) is a general deficiency of corticotropin Amount and indications for use. Admin- (ACTH). ister by subcutaneous injection either: (iii) Limitations. Federal law restricts (i) 6 mg per kilogram (/kg) of body this drug to use by or on the order of a weight, repeated in 48 hours, for the licensed veterinarian. treatment of bovine respiratory disease (3) Cattle—(i) Amount. Administer 200 (BRD) associated with Mannheimia to 600 units by intramuscular or sub- haemolytica and Pasteurella multocida; cutaneous injection as an initial dose, or followed by a dose daily or every other (ii) 8 mg/kg of body weight as a single day of 200 to 300 units. dose for the treatment of BRD associ- (ii) Indications for use. As a thera- ated with M. haemolytica and P. peutic agent for primary bovine keto- multocida and for the control of BRD in sis; and for stimulation of the adrenal beef cattle at high risk of developing

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BRD associated with M. haemolytica § 522.535 Desoxycorticosterone. and P. multocida. (a) Specifications. Each milliliter of (2) Limitations. Animals intended for suspension contains 25 milligrams (mg) human consumption should not be of desoxycorticosterone pivalate. slaughtered within 4 days from the last treatment. Do not use in cattle in- (b) Sponsors. See sponsor numbers in tended for dairy production. A with- § 510.600(c) of this chapter. drawal period has not been established (1) No. 043264 for use as in paragraphs for this product in pre-ruminating (c)(1)(i), (c)(2)(i), and (c)(3) of this sec- calves. Do not use in calves to be proc- tion. essed for veal. Federal law restricts (2) No. 058198 for use as in paragraphs this drug to use by or on the order of a (c)(1)(ii), (c)(2)(ii), and (c)(3) of this sec- licensed veterinarian. Federal law pro- tion. hibits the extra-label use of this drug (c) Conditions of use—(1) Amount. (i) in food-producing animals. Administer an initial dose of 2.2 mg/ kilogram (1 mg/lb) of body weight by [67 FR 78972, Dec. 27, 2002, as amended at 77 subcutaneous injection. Subsequent FR 4227, Jan. 27, 2012; 79 FR 16185, Mar. 25, dosages should be individualized ac- 2014; 79 FR 53136, Sept. 8, 2014] cording to label instructions based on § 522.533 Deslorelin. patient response to therapy. (ii) Dosage requirements are variable (a) Specifications—(1) Each implant and must be individualized on the basis contains 2.1 milligrams (mg) deslorelin of the response of the patient to ther- acetate. apy. Initial dose of 1 milligram per (2) Each milliliter (mL) of suspension pound (0.45 kilogram) of body weight contains 1.8 mg deslorelin acetate. every 25 days, intramuscularly. Usual (b) Sponsors. See sponsor numbers in dose is 0.75 to 1.0 milligram per pound § 510.600(c) of this chapter as follows: of body weight every 21 to 30 days. (1) No. 051311 for use of product de- (2) Indications for use—(i) For use as scribed in paragraph (a)(1) as in para- replacement therapy for graph (c)(1) of this section. mineralocorticoid deficiency in dogs (2) No. 051330 for use of product de- with primary hypoadrenocorticism scribed in paragraph (a)(2) as in para- (Addison’s Disease). graph (c)(2) of this section. (ii) For use as replacement therapy (c) Conditions of use—(1) Horses and for the mineralocorticoid deficit in ponies—(i) Amount. One implant per dogs with primary adrenocortical in- mare subcutaneously in the neck. sufficiency. (ii) Indications for use. For inducing ovulation within 48 hours in estrous (3) Limitations. Federal law restricts mares with an ovarian follicle greater this drug to use by or on the order of a than 30 mL in diameter. licensed veterinarian. (iii) Limitations. Do not use in horses [81 FR 22524, Apr. 18, 2016] or ponies intended for human consumption. Federal law restricts this drug to § 522.536 Detomidine. use by or on the order of a licensed vet- (a) Specification. Each milliliter of so- erinarian. lution contains 10 milligrams of (2) Horses—(i) Amount. Administer 1.8 detomidine hydrochloride. mg (1 mL) by intramuscular injection (b) Sponsor. See No. 052483 in in the neck. § 510.600(c) of this chapter. (ii) Indications for use. For inducing (c) Conditions of use in horses—(1) ovulation within 48 hours in cyclic es- Amount. For sedation, analgesia, or se- trous mares with an ovarian follicle be- dation and analgesia: 20 or 40 tween 30 and 40 mL in diameter. micrograms per kilogram (0.2 or 0.4 (iii) Limitations. Do not use in horses milliliter per 100 kilogram or 220 intended for human consumption. Fed- pounds) by body weight, depending on eral law restricts this drug to use by or depth and duration required. For seda- on the order of a licensed veterinarian. tion, administer by intraveneous (IV) [75 FR 81456, Dec. 28, 2010, as amended at 79 or intramuscular (IM) injection; for an- FR 18158, Apr. 1, 2014] algesia, administer by IV injection; for

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both sedation and analgesia, admin- dexamethasone sodium phosphate in- ister by IV injection. jections. (2) Indication for use. As a sedative (3) Conditions of use—(i) Amount. Ad- and analgesic to facilitate minor sur- minister 0.25 to 1 mg by intravenous in- gical and diagnostic procedures in ma- jection, repeated for 3 to 5 days or until ture horses and yearlings. a response is noted. (3) Limitations. Do not use in horses (ii) Indications for use. For use in dogs intended for human consumption. Fed- for the treatment of inflammatory con- eral law restricts this drug to use by or ditions, as supportive therapy in ca- on the order of a licensed veterinarian. nine posterior paresis, as supportive [79 FR 16186, Mar. 25, 2014] therapy before or after surgery to enhance recovery of poor surgical risks, § 522.540 Dexamethasone solution. and as supportive therapy in nonspe- (a)(1) Specifications. Each milliliter of cific dermatosis. solution contains 2 milligrams (mg) (iii) Limitations. Federal law restricts dexamethasone. this drug to use by or on the order of a (2) Sponsors. See sponsors in licensed veterinarian. § 510.600(c) of this chapter: (c)(1) Specifications. Each milliliter of (i) Nos. 000061, 016592, and 061623 for solution contains 2.0 mg of dexametha- use as in paragraph (a)(3) of this sec- sone or 4.0 mg of dexamethasone so- tion. dium phosphate (equivalent to 3.0 mg (ii) Sponsors. See Nos. 054925 and of dexamethasone). 058005 for use as in paragraphs (2) Sponsor. See Nos. 000402 and 061623 (a)(3)(i)(C), (a)(3)(i)(D), (a)(3)(ii)(A), and in § 510.600(c) of this chapter. (a)(3)(iii) of this section. (3) Conditions of use—(i) Amount. Ad- (3) Conditions of use—(i) Amount. The minister 2.5 to 5.0 mg by intravenous drug is administered intravenously or injection. intramuscularly and dosage may be re- (ii) Indications for use. For use in peated if necessary, as follows: horses as a rapid adrenal (A) Dogs. 0.25 to 1 mg. glucocorticoid and/or anti-inflam- (B) Cats. 0.125 to 0.5 mg. matory agent. (C) Horses. 2.5 to 5 mg. (iii) Limitations. Do not use in horses (D) Cattle. 5 to 20 mg, depending on intended for human consumption. Fed- the severity of the condition. eral law restricts this drug to use by or (ii) Indications for use. The drug is in- on the order of a licensed veterinarian. dicated: (d)(1) Specifications. Each milliliter of (A) For the treatment of primary bo- solution contains 2.0 mg of dexametha- vine ketosis and as an anti-inflam- sone or 4.0 mg of dexamethasone so- matory agent in cattle and horses; dium phosphate (equivalent to 3.0 mg (B) As an anti-inflammatory agent in of dexamethasone). dogs and cats. (2) Sponsors. See the following num- (iii) Limitations. Do not use in horses bers in § 510.600(c) of this chapter: intended for human consumption. Fed- (i) Nos. 016592 and 051031 for intra- eral law restricts this drug to use by or venous or intramuscular use of 2.0 mil- on the order of a licensed veterinarian. ligrams dexamethasone injection. (b)(1) Specifications. Each milliliter of (ii) No. 054771 for intravenous use of solution contains 2.0 mg of dexametha- 2.0 milligrams dexamethasone injec- sone or 4.0 mg of dexamethasone so- tion. dium phosphate (equivalent to 3.0 mg dexamethasone). (3) Conditions of use—(i) Amount. Ad- (2) Sponsor. See number in § 510.600(c) minister by intravenous or of this chapter as follows: intramuscular injection as follows: (i) No. 061623 for use of 2.0 milligrams (A) Dogs: 0.25 to 1 mg. dexamethasone or 4.0 milligrams dexa- (B) Cats: 0.125 to 0.5 mg. methasone sodium phosphate injec- (C) Horses: 2.5 to 5 mg. tions. (ii) Indications for use. For use in (ii) No. 000402 for use of 2.0 milli- dogs, cats, and horses as an anti-in- grams dexamethasone or 4.0 milligrams flammatory agent.

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(iii) Limitations. Do not use in horses 0.5 mg; horses: 5 to 20 mg. Dosage may intended for human consumption. Fed- be repeated. eral law restricts this drug to use by or (2) Indications for use. For the treat- on the order of a licensed veterinarian. ment of various inflammatory condi- (e)(1) Specifications. Each milliliter of tions associated with the musculo- solution contains 4.0 mg of dexametha- skeletal system in dogs, cats, and sone sodium phosphate (equivalent to horses. 3.0 mg dexamethasone). (3) Limitations. Do not use in horses (2) Sponsor. See No. 069043 in intended for human consumption. Fed- § 510.600(c) of this chapter. eral law restricts this drug to use by or (3) Conditions of use—(i) Amount. Ad- on the order of a licensed veterinarian. minister by intravenous injection as follows: [79 FR 16186, Mar. 25, 2014] (A) Dogs: 0.25 to 1 mg; may be repeated for 3 to 5 days. § 522.558 Dexmedetomidine. (B) Horses: 2.5 to 5 mg. (a) Specifications. Each milliliter of (ii) Indications for use. For use in dogs solution contains: and horses for glucocorticoid and anti- (1) 0.1 milligrams (mg) inflammatory effect. dexmedetomidine hydrochloride; or (iii) Limitations. Do not use in horses (2) 0.5 mg dexmedetomidine hydro- intended for human consumption. Fed- eral law restricts this drug to use by or chloride. on the order of a licensed veterinarian. (b) Sponsors. See sponsors in in § 510.600(c) of this chapter for use as in [41 FR 28265, July 9, 1976] paragraph (c) of this section: EDITORIAL NOTE: For FEDERAL REGISTER ci- (1) No. 026637 for use of product de- tations affecting § 522.540, see the List of CFR scribed in paragraph (a)(2) of this sec- Sections Affected, which appears in the tion; Finding Aids section of the printed volume and at www.fdsys.gov. (2) No. 052483 for use of products described in paragraph (a) of this section. EFFECTIVE DATE NOTE: At 83 FR 13635, Mar. (c) Conditions of use—(1) Dogs—(i) In- 30, 2018, § 522.540 was amended by revising paragraphs (b)(2) and (c)(2), effective Apr. 9, dications for use and amount. (A) For 2018. For the convenience of the user, the re- use as a sedative and analgesic to fa- vised text is set forth as follows: cilitate clinical examinations, clinical procedures, minor surgical procedures, § 522.540 Dexamethasone solution. and minor dental procedures, administer 375 micrograms (μg) per square * * * * * meter (/m2) of body surface area by in- (b) * * * travenous injection or 500 μg/m2 of body (2) Sponsor. See No. 061623 in § 510.600(c) of surface area by intramuscular injec- this chapter. tion. (B) For use as a preanesthetic to gen- * * * * * eral anesthesia, administer 125 μg/m2 of (c) * * * body surface area or 375 μg/m2 of body (2) Sponsor. See No. 061623 in § 510.600(c) of surface area by intramuscular injec- this chapter. tion. (ii) Limitations. Federal law restricts * * * * * this drug to use by or on the order of a licensed veterinarian. § 522.542 Dexamethasone suspension. (2) Cats—(i) Amount. 40 μg/killogram (a) Specifications. Each milliliter of by intramuscular injection. suspension contains 1 milligram (mg) (ii) Indications for use. For use as a of dexamethasone-21-isonicotinate. sedative and analgesic to facilitate (b) Sponsor. No. 000010 in § 510.600(c) of clinical examinations, clinical proce- this chapter. dures, minor surgical procedures, and (c) Conditions of use—(1) Amount. Ad- minor dental procedures; and as a minister by intramuscular injection as follows: Dogs: 0.25 to 1 mg; cats: 0.125 to preanesthetic to general anesthesia.

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(iii) Limitations. Federal law restricts venography; selective coronary arteri- this drug to use by or on the order of a ography; cerebral angiography; licensed veterinarian. lymphography; arthrography; discography; and sialography; and as an aid [72 FR 263, Jan. 4, 2007, as amended at 72 FR 19797, Apr. 20, 2007; 72 FR 51365, Sept. 7, 2007; in delineating peritoneal hernias and 75 FR 60308, Sept. 30, 2010; 78 FR 25183, Apr. fistulous tracts. 30, 2013; 78 FR 33699, June 5, 2013; 80 FR 13229, (3) Limitations. Federal law restricts Mar. 13, 2015] this drug to use by or on the order of a licensed veterinarian. § 522.563 Diatrizoate. (a) Specifications. Each milliliter of [79 FR 16186, Mar. 25, 2014] solution contains 34.3 percent dia- § 522.650 Dihydrostreptomycin sulfate trizoate meglumine and 35 percent dia- injection. trizoate sodium, or 66 percent diatrizoate meglumine and 10 percent dia- (a) Specifications. Each milliliter con- trizoate sodium. tains dihydrostreptomycin sulfate (b) Sponsor. See No. 054771 in equivalent to 500 milligrams of dihy- § 510.600(c) of this chapter. drostreptomycin. (c) Conditions of use in dogs and cats— (b) Sponsors. See Nos. 054771 and (1) Amount. For excretion urography, 055529 in § 510.600(c) of this chapter. administer 0.5 to 1.0 milliliter (mL) per (c) Related tolerance. See § 556.200 of pound of body weight to a maximum of this chapter. 30 mL intravenously. For cystography, (d) Conditions of use—(1) Amount. Ad- remove urine, administer 5 to 25 mL di- minister 5 milligrams per pound of rectly into the bladder via catheter. body weight by deep intramuscular in- For urethrography, administer 1.0 to 5 jection every 12 hours, for 3 to 5 days or mL via catheter into the urethra to until the urine is free of leptospira for provide desired contrasts delineation. at least 72 hours as measured by For angiocardiography (including darkfield microscopic examination. aortography) rapidly inject 5 to 10 mL (2) Indications for use. Treatment of directly into the heart via catheter or leptospirosis in dogs and horses due to intraventricular puncture. For cerebral Leptospira canicola, L. angiography, rapid injection of 3 to 10 icterohemorrhagiae, and L. pomona; in mL via carotid artery. For peripheral cattle due to L. pomona; and in swine arteriography and/or venography and due to L. pomona; and L. grippotyphosa. selective coronary arteriography, rap- (3) Limitations. Discontinue use 30 idly inject 3 to 10 mL intravascularly days before slaughter for food. Not for into the vascular bed to be delineated. use in animals producing milk because For lymphography, slowly inject 1.0 to use of the drug will contaminate the 10 mL directly into the lymph vessel to milk. Federal law restricts this drug to be delineated. For arthrography, slow- use by or on the order of a licensed vet- ly inject 1.0 to 5 mL directly into the erinarian. joint to be delineated. For discography, slowly inject 0.5 to 1.0 mL directly into [57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept. the disc to be delineated. For sialog- 15, 1992; 79 FR 16187, Mar. 25, 2014] raphy, slowly inject 0.5 to 1.0 mL into § 522.690 Dinoprost. the duct to be delineated. For delineation of fistulous tracts, slowly inject (a) Specifications. Each milliliter quantity necessary to fill the tract. (mL) of solution contains dinoprost For delineation of peritoneal hernias, tromethamine equivalent to 5 milli- inject 0.5 to 1.0 mL per pound of body grams (mg) or 12.5 mg dinoprost. weight directly into the peritoneal cav- (b) Sponsors. See sponsors in ity. § 510.600(c) of this chapter. (2) Indications for use. For visualiza- (1) No. 054771 for use of the 12.5 mg/ tion in excretion urography, including mL product as in paragraph (d)(1) of renal angiography, uretography, this section. cystography, and urethrography; (2) No. 054771 for use of the 5 mg/mL aortography; angiocardiography, pe- product as in paragraphs (d)(1), (2), and ripheral arteriography, and (3) of this section.

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(3) No. 061623 for use of the 5 mg/mL within 3 days of normal predicted product as in paragraphs (d)(2), (3), and farrowing. (4) of this section. (4) Cattle. Administer product de- (c) Special considerations. Federal law scribed in paragraph (b)(2) of this sec- restricts this drug to use by or on the tion as follows: order of a licensed veterinarian. (i) Beef cattle and nonlactating dairy (d) Conditions of use—(1) Cattle. Ad- heifers—(A) Amount. 25 mg as an minister product described in para- intramuscular injection either once or graph (b)(1) of this section as follows: twice at a 10- to 12-day interval. (i) Amount. 25 mg as a single (B) Indications. For its luteolytic ef- intramuscular or subcutaneous injec- fect to control timing of estrus and tion. ovulation in estrous cycling cattle that (ii) Indications for use. As a luteolytic have a corpus luteum. agent; effective only in those cattle (ii) Beef cattle and nonlactating dairy having a corpus luteum, i.e., those heifers—(A) Amount. 25 mg as a single which ovulated at least 5 days prior to intramuscular injection. treatment. (B) Indications. For treatment of (A) For estrus synchronization in pyometra (chronic endometritis). beef cows, beef heifers and replacement (iii) Nonlactating cattle—(A) Amount. dairy heifers. 25 mg as a single intramuscular injection during the first 100 days of gesta- (B) For unobserved (silent) estrus in tion. lactating dairy cows with a corpus (B) Indications. For its abortifacient luteum. effect in nonlactating cattle. (C) For treatment of pyometra (iv) Lactating dairy cattle—(A) (chronic endometritis) in cattle. Amount. 25 mg as a single (D) For abortion in beef cows, beef intramuscular injection. heifers and replacement dairy heifers. (B) Indications. For treatment of (E) For use with gonadorelin injec- unobserved (silent) estrus in lactating tion as in § 522.1077 of this chapter to dairy cattle that have a corpus luteum. synchronize estrous cycles to allow (v) Dinoprost injection as provided by fixed-time artificial insemination No. 054771 in § 510.600(c) of this chapter (FTAI) in lactating dairy cows. may also be used concurrently with (F) For use with progesterone gonadorelin hydrochloride injection as intravaginal inserts as in § 529.1940 of in § 522.1077 and with progesterone this chapter for synchronization of intravaginal inserts as in § 529.1940 of estrus in lactating dairy cows. this chapter. (G) For use with progesterone intravaginal inserts as in § 529.1940 of [67 FR 41824, June 20, 2002, as amended at 79 FR 16187, Mar. 25, 2014; 79 FR 44278, July 31, this chapter for synchronization of 2014; 79 FR 64116, Oct. 28, 2014; 80 FR 61296, estrus in suckled beef cows and re- Oct. 13, 2015; 80 FR 76386, Dec. 9, 2015; 81 FR placement beef and dairy heifers, ad- 36789, June 8, 2016] vancement of first postpartum estrus in suckled beef cows, and advancement § 522.723 Diprenorphine. of first pubertal estrus in beef heifers. (a) Specifications. Each milliliter of (2) Horses—(i) Amount. 1 mg per 100 solution contains 2 milligrams of pounds of body weight as a single diprenorphine hydrochloride. intramuscular injection. (b) Sponsors. See No. 053923 in (ii) Indications for use. For its § 510.600(c) of this chapter. luteolytic effect to control timing of (c) Conditions of use—(1) Amount. It is estrus in estrus cycling mares and in administered intramuscularly or intra- clinically anestrous mares that have a venously at a suitable dosage level de- corpus luteum. pending upon the species. (iii) Limitations. Do not use in horses (2) Indications for use. The drug is intended for human consumption. used for reversing the effects of (3) Swine—(i) Amount. 10 mg as a sin- etorphine hydrochloride injection, vet- gle intramuscular injection. erinary, the use of which is provided (ii) Indications for use. For parturi- for in § 522.883, in wild and exotic ani- tion induction in swine when injected mals.

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(3) Limitations. For use in wild or ex- sistance in the diagnosis, treatment, otic animals only. Do not use in domes- and control of parasitism. tic food-producing animals. Do not use [61 FR 53321, Oct. 11, 1996, as amended at 62 30 days before, or during, the hunting FR 44410, Aug. 21, 1997; 62 FR 62242, Nov. 21, season in free-ranging wild animals 1997; 63 FR 68183, Dec. 10, 1998; 64 FR 13509, that might be used for food. Federal Mar. 19, 1999; 79 FR 16187, Mar. 25, 2014] law restricts this drug to use by or on the order of a licensed veterinarian. § 522.775 Doxapram. Distribution is restricted to veterinar- (a) Specifications. Each milliliter of ians engaged in zoo and exotic animal solution contains 20 milligrams (mg) practice, wildlife management pro- doxapram hydrochloride. grams, and researchers. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. [79 FR 16187, Mar. 25, 2014] (c) Conditions of use—(1) Amount. For intravenous use in dogs and cats at a § 522.770 Doramectin. dose of 21⁄2 to 5 mg per pound (/lb) body (a) Specifications. Each milliliter of weight in barbiturate anesthesia, 0.5 solution contains 10 milligrams of mg/lb in inhalation anesthesia; for in- doramectin. travenous use in horses at 0.25 mg/lb (b) Sponsor. See No. 054771 in § 510.600 body weight in barbiturate anesthesia, (c) of this chapter. 0.2 mg/lb in inhalation anesthesia, 0.25 (c) Related tolerances. See § 556.225 of mg/lb with chloral hydrate with or this chapter. without magnesium sulfate; for sub- (d) Conditions of use—(1) Cattle—(i) cutaneous, sublingual, or umbilical Amount. 200 micrograms per kilogram vein administration in neonate puppies at a dose rate of 1 to 5 mg; for subcuta- (10 milligrams per 110 pounds). neous or sublingual use in neonate kit- (ii) For treatment Indications for use. tens at 1 to 2 mg. Dosage may be re- and control of gastrointestinal peated in 15 to 20 minutes if necessary. roundworms, lungworms, eyeworms, (2) Indications for use. Administer to grubs, sucking lice, and mange mites. dogs, cats, and horses to stimulate res- To control infections and to protect piration during and after general anes- from reinfection with Cooperia thesia; or to speed awakening and re- oncophora and Haemonchus placei for 14 turn of reflexes after anesthesia. Ad- days, Ostertagia ostertagi for 21 days, minister to neonate dogs and cats to and C. punctata, Oesophagostomum initiate respiration following dystocia radiatum, and Dictyocaulus viviparus for or caesarean section; or to stimulate 28 days after treatment. respiration following dystocia or cae- (iii) Limitations. Administer as a sin- sarean section. gle subcutaneous or intramuscular in- (3) Limitations. Federal law restricts jection. Do not slaughter cattle within this drug to use by or on the order of a 35 days of treatment. Not for use in fe- licensed veterinarian. male dairy cattle 20 months of age or [72 FR 261, Jan. 4, 2007, as amended at 75 FR older. Do not use in calves to be proc- 10167, Mar. 5, 2010; 77 FR 60302, Oct. 3, 2012] essed for veal. (2) Swine—(i) Amount. 300 micrograms § 522.784 Doxylamine. per kilogram (10 milligrams per 75 (a) Specifications. Each milliliter con- pounds). tains 11.36 milligrams (mg) of (ii) Indications for use. For treatment doxylamine succinate. and control of gastrointestinal (b) Sponsor. See No. 000061 in roundworms, lungworms, kidney § 510.600(c) of this chapter. worms, sucking lice, and mange mites. (c) Conditions of use—(1) Amount—(i) (iii) Limitations. Administer as a sin- Horses: Administer 25 mg per hundred gle intramuscular injection. Do not pounds of body weight by slaughter swine within 24 days of treat- intramuscular, subcutaneous, or slow ment. Consult your veterinarian for as- intravenous injection. (ii) Dogs and cats: Administer 0.5 to 1 mg per pound of body weight by

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intramuscular or subcutaneous injec- (3) Limitations. Federal law restricts tion. Doses may be repeated at 8 to 12 this drug to use by or on the order of a hours, if necessary, to produce desired licensed veterinarian. effect. [79 FR 16187, Mar. 25, 2014] (2) Indications for use. For use in conditions in which antihistaminic ther- § 522.810 Embutramide, chloroquine, apy may be expected to alleviate some and lidocaine solution. signs of disease in horses, dogs, and (a) Specifications. Each milliliter cats. (mL) of solution contains 135 milli- (3) Do not use in horses Limitations. grams (mg) embutramide; 45 mg intended for human consumption. Fed- chloroquine phosphate, U.S.P.; and 1.9 eral law restricts this drug to use by or mg lidocaine, U.S.P. on the order of a licensed veterinarian. (b) Sponsor. See No. 069043 in [79 FR 16187, Mar. 25, 2014] § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) § 522.800 Droperidol and fentanyl. Amount. One mL per 5 pounds of body (a) Specifications. Each milliliter of weight. solution contains 20 milligrams (mg) of (2) Indications for use. For euthanasia. droperidol and 0.4 mg of fentanyl cit- (3) Limitations. Not for use in animals rate. intended for food. Federal law restricts (b) Sponsor. See No. 000061 in this drug to use by or on the order of a § 510.600(c) of this chapter. licensed veterinarian. (c) Conditions of use—(1) Amount. [70 FR 36337, June 23, 2005, as amended at 78 (i) For analgesia and tranquilization, FR 17597, Mar. 22, 2013; 81 FR 17608, Mar. 30, administer as follows: 2016] (A) 1 milliliter (mL) per 15 to 20 pounds (lbs) of body weight by § 522.812 Enrofloxacin. intramuscular injection in conjunction (a) Specifications. Each milliliter with atropine sulfate administered at (mL) of solution contains: the rate of 0.02 mg per pound of body (1) 22.7 milligrams (mg) enrofloxacin weight; or or (B) 1 mL per 25 to 60 lbs of body (2) 100 mg enrofloxacin. weight by intravenous injection in con- (b) Sponsors. See sponsor numbers in junction with atropine sulfate adminis- § 510.600(c) of this chapter: tered at the rate of 0.02 mg per pound (1) No. 000859 for use of products de- of body weight. scribed in paragraph (a) as in para- (ii) For general anesthesia, admin- graph (e) of this section; and ister as follows: (2) No. 055529 for use of product de- (A) Administer 1 mL per 40 lbs of scribed in paragraph (a)(1) of this sec- body weight by intramuscular injection as in paragraph (e)(1) of this section in conjunction with atropine sul- tion, and use of product described in fate administered at the rate of 0.02 mg paragraph (a)(2) in this section as in per pound of body weight and followed paragraphs (e)(2), (e)(3)(i)(B), and in 10 minutes by an intravenous admin- (e)(3)(ii) of this section. istration of sodium pentobarbital at (3) No. 026637 for use of product de- the rate of 3 mg per pound of body scribed in paragraph (a)(1) as in para- weight; or graph (e)(1) of this section. (B) Administer 1 mL per 25 to 60 lbs (c) Related tolerance. See § 556.226 of of body weight by intravenous injec- this chapter. tion in conjunction with atropine sul- (d) Special considerations. Federal law fate administered at the rate of 0.02 mg restricts this drug to use by or on the per pound of body weight and followed order of a licensed veterinarian. Fed- within 15 seconds by an intravenous ad- eral law prohibits the extra-label use of ministration of sodium pentobarbital this drug in food-producing animals. at the rate of 3 mg per pound of body (e) Conditions of use—(1) Dogs. Use the weight. product described in paragraph (a)(1) of (2) Indications for use. As an analgesic this section as follows: and tranquilizer and for general anes- (i) Amount. 2.5 mg per kilogram (/kg) thesia. of body weight (1.13 mg per pound) as a

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single, intramuscular, initial dose fol- (3) Swine. Use the product described lowed by use of tablets twice daily for in paragraph (a)(2) of this section as 2 to 3 days beyond cessation of clinical follows: signs to a maximum of 10 days. (i) Amounts and indications for use. (A) (ii) Indications for use. For the man- Administer, either by intramuscular or agement of diseases associated with subcutaneous (behind the ear) injec- bacteria susceptible to enrofloxacin. tion, a single dose of 7.5 mg/kg of body (2) Cattle. Use the product described weight for the treatment and control of in paragraph (a)(2) of this section as swine respiratory disease (SRD) associ- follows: ated with Actinobacillus pleuropneumoniae, Pasteurella multocida, (i) Amount—(A) Single-dose therapy: Haemophilus parasuis, Streptococcus suis, For treatment of bovine respiratory Bordetella bronchiseptica, and Myco- disease (BRD), administer 7.5 to 12.5 plasma hyopneumoniae. mg/kg of body weight (3.4 to 5.7 mL per (B) Administer, by subcutaneous (be- 100 pounds (/100 lb)) once by subcuta- hind the ear) injection, a single dose of neous injection. For control of BRD, 7.5 mg/kg of body weight for the treat- administer 7.5 mg/kg of body weight ment and control of swine respiratory (3.4 mL/100 lb) once by subcutaneous in- disease (SRD) associated with jection. Actinobacillus pleuropneumoniae, (B) Multiple-day therapy: For treat- Pasteurella multocida, Haemophilus ment of BRD, administer 2.5 to 5.0 mg/ parasuis, and Streptococcus suis. kg of body weight (1.1 to 2.3 mL/100 lb) (C) Administer, either by by subcutaneous injection. Treatment intramuscular or subcutaneous (behind should be repeated at 24-hour intervals the ear) injection, a single dose of 7.5 for 3 days. Additional treatments may mg/kg of body weight for the control of be given on days 4 and 5 to animals colibacillosis in groups or pens of that have shown clinical improvement weaned pigs where colibacillosis associ- but not total recovery. ated with Escherichia coli has been diag- (ii) Indications for use—(A) Single-dose nosed. therapy: For the treatment of BRD as- (ii) Limitations. Animals intended for sociated with Mannheimia haemolytica, human consumption must not be Pasteurella multocida, Histophilus somni, slaughtered within 5 days of receiving and Mycoplasma bovis in beef and non- a single-injection dose. lactating dairy cattle; for the control [72 FR 10597, Mar. 9, 2007, as amended at 73 of BRD in beef and non-lactating dairy FR 17890, Apr. 2, 2008; 73 FR 21819, Apr. 23, cattle at high risk of developing BRD 2008; 76 FR 22611, Apr. 22, 2011; 77 FR 55415, associated with M. haemolytica, P. Sept. 10, 2012; 77 FR 76863, Dec. 31, 2012; 78 FR multocida, H. somni and M. bovis. 19987, Apr. 3, 2013; 79 FR 37620, July 2, 2014; 80 FR 13229, Mar. 13, 2015; 80 FR 18776, Apr. 8, (B) Multiple-day therapy: For the 2015; 80 FR 61296, Oct. 13, 2015] treatment of bovine respiratory disease (BRD) associated with Mannheimia § 522.814 Eprinomectin. haemolytica, Pasteurella multocida, and (a) Specifications. Each milliliter of Histophilus somni in beef and non-lac- solution contains 50 milligrams (mg) tating dairy cattle. eprinomectin. (iii) Limitations. Animals intended for (b) Sponsor. See No. 050604 in human consumption must not be § 510.600(c) of this chapter. slaughtered within 28 days from the (c) Related tolerances. See §§ 500.1410 last treatment. This product is not ap- and 556.227 of this chapter. proved for female dairy cattle 20 (d) Conditions of use in cattle on pas- months of age or older, including dry ture—(1) Amount. Administer 1 mg/kilo- dairy cows. Use in these cattle may gram of body weight by subcutaneous cause drug residues in milk and/or in injection. calves born to these cows. A with- (2) Indications for use. For the treat- drawal period has not been established ment and control of the following infor this product in preruminating ternal and external parasites: Gastro- calves. Do not use in calves to be proc- intestinal roundworms (adults and essed for veal. fourth-stage larvae) Bunostomum

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phlebotomum, Cooperia oncophora, C. (iii) Limitations. Federal law restricts punctata, C. surnabada, Trichostrongylus this drug to use by or on the order of a axei, Ostertagia ostertagi (including in- licensed veterinarian. hibited stage); (adults) Haemonchus (2) Cats. Administer product de- placei, Oesophagostomum radiatum, O. scribed in paragraph (a)(1) of this sec- lyrata, T. colubriformis; lungworms tion as follows: (adults) Dictyocaulus viviparus; cattle (i) Amount. 3 to 5 mg/lb body weight, grubs Hypoderma bovis; mites Sarcoptes intramuscularly, two to three times scabiei var. bovis. Prevents reinfection daily, for up to 5 days. with C. oncophora, C. punctata, and T. (ii) Indications for use. For the treat- axei for 100 days following treatment; ment of bacterial pneumonia, upper H. placei, O. radiatum, O. lyrata, and O. respiratory infections (rhinitis, bron- ostertagi for 120 days following treat- chitis), secondary infections associated ment; and B. phlebotomum and D. with panleukopenia, and bacterial viviparus for 150 days following treat- wound infections caused by Staphy- ment. lococcus spp. and Streptococcus spp., sus- (3) Limitations. Federal law restricts ceptible to erythromycin. this drug to use by or on the order of a (iii) Limitations. Federal law restricts licensed veterinarian. Animals in- this drug to use by or on the order of a tended for human consumption must licensed veterinarian. not be slaughtered within 48 days of (3) Cattle. Administer products de- the last treatment. This drug product scribed in paragraph (a) of this section is not approved for use in female dairy as follows: cattle 20 months of age or older, in- (i) Amount. 4 mg/lb body weight by cluding dry dairy cows. Use in these deep intramuscular injection once cattle may cause drug residues in milk daily for up to 5 days. and/or in calves born to these cows. A (ii) Indications for use. For the treat- withdrawal period has not been estab- ment of bovine respiratory disease lished for pre-ruminating calves. Do (shipping fever complex and bacterial not use in calves to be processed for pneumonia) associated with Pasteurella veal. multocida susceptible to erythromycin. (iii) Limitations. Do not use in female [76 FR 72618, Nov. 25, 2011, as amended at 79 FR 37620, July 2, 2014] dairy cattle over 20 months of age. Do not slaughter treated animals within 6 § 522.820 Erythromycin. days of last treatment. A withdrawal (a) Specifications—(1) Each milliliter period has not been established for this (mL) of solution contains 100 milli- product in pre-ruminating calves. Do grams (mg) erythromycin base. not use in calves to be processed for (2) Each mL of solution contains 200 veal. To avoid excess trim, do not mg erythromycin base. slaughter within 21 days of last injec- (b) Sponsor. See No. 061623 in tion. § 510.600(c) of this chapter. [72 FR 69142, Dec. 7, 2007, as amended at 79 (c) Related tolerances. See § 556.230 of FR 16187, Mar. 25, 2014] this chapter. (d) Conditions of use—(1) Dog. Admin- § 522.840 Estradiol. ister product described in paragraph (a) Specifications. Each silicone rub- (a)(1) of this section as follows: ber implant contains 25.7 or 43.9 milli- (i) Amount. 3 to 5 mg per pound (/lb) grams (mg) estradiol and is coated with body weight, intramuscularly, two to not less than 0.5 mg oxytetracycline three times daily, for up to 5 days. powder. (ii) Indications for use. For the treat- (b) Sponsor. See No. 058198 in ment of bacterial pneumonia, upper § 510.600(c) of this chapter. respiratory infections (tonsillitis, (c) Related tolerances. See § 556.240 of bronchitis, tracheitis, pharyngitis, this chapter. pleurisy), endometritis and metritis, (d) Conditions of use. For implanta- and bacterial wound infections caused tion in steers and heifers as follows: by Staphylococcus spp., Streptococcus (1) Amount. Insert one 25.7-mg im- spp., and Corynebacterium spp., sen- plant every 200 days; insert one 43.9-mg sitive to erythromycin. implant every 400 days.

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(2) Indications for use. For increased preruminating calves. Do not use in rate of weight gain in suckling and calves to be processed for veal. pastured growing steers; for improved [69 FR 68252, Nov. 24, 2004, as amended at 77 feed efficiency and increased rate of FR 31723, May 30, 2012; 79 FR 16187, Mar. 25, weight gain in confined steers and heif- 2014; 81 FR 48702, July 26, 2016] ers. No additional effectiveness may be expected from reimplanting in less § 522.850 Estradiol valerate and than 200 days for the 25.7-mg implant norgestomet in combination. or 400 days for the 43.9-mg implant. (a) Specifications. The product is a (3) Limitations. For subcutaneous ear two-component drug consisting of the implantation in steers and heifers only. following: Safety and effectiveness have not been (1) An implant containing 6.0 milli- established in veal calves. A with- grams of norgestomet. drawal period has not been established (2) An injectable solution (sesame for this product in preruminating oil) containing 3.0 milligrams of calves. Do not use in calves to be proc- norgestomet and 5.0 milligrams of es- essed for veal. tradiol valerate per 2 milliliters. (b) Sponsor. See 050604 in § 510.600(c) of [69 FR 67818, Nov. 22, 2004, as amended at 77 FR 31723, May 30, 2012; 81 FR 48702, July 26, this chapter. 2016] (c) Conditions of use—(1) Amount. One implant and 2 milliliters of injection at § 522.842 Estradiol benzoate and tes- time of implantation. tosterone propionate. (2) Indications for use. For synchroni- (a) Sponsors. See sponsors in zation of estrus/ovulation in cycling § 510.600(c) of this chapter for use as in beef cattle and non-lactating dairy paragraph (c) of this section. heifers. (1) No. 054771 for use as in paragraph (3) Limitations. Insert implant (c)(1)(i), (c)(2), and (c)(3) of this section. subcutaneously in the ear only; then (2) No. 058198 for use as in paragraph immediately inject solution (c) of this section. intramuscularly only. Counting the (b) Related tolerances. See §§ 556.240 day of implantation as day 1, remove and 556.710 of this chapter. the implant on day 10. Collect all im- (c) Conditions of use. For implanta- plants as they are removed and burn tion in heifers as follows: them. While animals are restrained for (1) Amount. (i) 20 milligrams (mg) es- artificial insemination, avoid other tradiol benzoate and 200 mg testos- treatments such as vaccinations, dip- terone propionate (one implant con- ping, pour-on grub and louse preven- sisting of 8 pellets, each pellet con- tion, spraying, etc. When inseminating taining 2.5 mg estradiol benzoate and without estrus detection, the entire 25 mg testosterone propionate) per im- treated group should be started at 48 plant dose. hours after the last implant has been (ii) 20 mg estradiol benzoate and 200 removed and should be completed with- mg testosterone propionate (one im- in 6 hours. Where estrus detection is plant consisting of 9 pellets, each of 8 preferred, insemination should be ap- pellets containing 2.5 mg estradiol ben- proximately 12 hours after first detec- zoate and 25 mg testosterone propio- tion of estrus. Those that do not con- nate, and 1 pellet containing 29 mg ceive can be re-bred when they return tylosin tartrate) per implant dose. to estrus approximately 17 to 25 days (2) Indications for use. For increased after implant removal. Do not use in rate of weight gain and improved feed cows producing milk for human con- efficiency. sumption. (3) Limitations. For heifers weighing [47 FR 55477, Dec. 10, 1982, as amended at 48 400 pounds or more; for subcutaneous FR 49656, Oct. 27, 1983; 51 FR 33592, Sept. 22, ear implantation, one dose per animal; 1986; 54 FR 1165, Jan. 12, 1989] not for use in dairy or beef replacement heifers. Safety and effectiveness have § 522.863 Ethylisobutrazine. not been established in veal calves. A (a) Specifications. Each milliliter of withdrawal period has not been estab- solution contains 50 milligrams (mg) of lished for this product in ethylisobutrazine hydrochloride.

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(b) Sponsor. See No. 000061 in 30 days before, or during, the hunting § 510.600(c) of this chapter. season in free-ranging wild animals (c) Conditions of use in dogs—(1) that might be used for food. Federal Amount. Administer 2 to 5 mg per law restricts this drug to use by or on pound of body weight by intramuscular the order of a licensed veterinarian. injection for profound tranquilization. [79 FR 16188, Mar. 25, 2014] Administer 1 to 2 mg per pound of body weight by intravenous injection to ef- § 522.900 Euthanasia solution. fect. (a) Specifications. Each milliliter (2) Indications for use. For use as a (mL) of solution contains: tranquilizer. (1) 390 milligrams (mg) of pento- (3) Limitations. Federal law restricts barbital sodium and 50 mg phenytoin this drug to use by or on the order of a sodium. licensed veterinarian. (2) 400 mg secobarbital sodium and 25 [79 FR 16187, Mar. 25, 2014] mg dibucaine hydrochloride. (b) Sponsors. See sponsors in § 522.870 Etodolac. § 510.600(c) of this chapter: (a) Specifications. Each milliliter con- (1) Nos. 000061, 051311, and 054925 for tains 100 milligrams (mg) etodolac. use of product described in paragraph (b) Sponsor. See No. 000010 in § 510.600 (a)(1) of this section. of this chapter. (2) No. 054771 for use of product de- (c) Conditions of use in dogs—(1) scribed in paragraph (a)(2) of this sec- Amount. Administer 4.5 to 6.8 mg/pound tion. (10 to 15 mg/kilogram) body weight as a (c) Special considerations. Product la- single, dorsoscapular subcutaneous in- beling shall bear the following warning jection. If needed, the daily dose of statements: ‘‘ENVIRONMENTAL HAZ- etodolac tablets as in § 520.870 of this ARD: This product is toxic to wildlife. chapter may be given 24 hours after the Birds and mammals feeding on treated injection. animals may be killed. Euthanized ani- (2) Indications for use. For the control mals must be properly disposed of by of pain and inflammation associated deep burial, incineration, or other with osteoarthritis. method in compliance with state and local laws, to prevent consumption of (3) Limitations. Federal law restricts carcass material by scavenging wild- this drug to use by or on the order of a life.’’ licensed veterinarian. (d) Conditions of use in dogs—(1) Indi- [72 FR 51365, Sept. 7, 2007, as amended at 75 cations for use. For humane, painless, FR 10167, Mar. 5, 2010] and rapid euthanasia. (2) Amount. One mL per 10 pounds of § 522.883 Etorphine. body weight. (a) Specifications. Each milliliter of (3) Limitations. Do not use in animals solution contains 1 milligram of intended for food. Federal law restricts etorphine hydrochloride. this drug to use by or on the order of a (b) Sponsor. See No. 053923 in licensed veterinarian. § 510.600(c) of this chapter. [68 FR 42969, July 21, 2003, as amended at 68 (c) Special considerations. Distribution FR 55824, Sept. 29, 2003; 70 FR 8929, Feb. 24, is restricted to veterinarians engaged 2005; 71 FR 13542, Mar. 16, 2006; 79 FR 16188, in zoo and exotic animal practice, wild- Mar. 25, 2014] life management programs, and researchers. § 522.914 Fenprostalene. (d) Conditions of use—(1) Amount. Ad- (a) Specifications. (1) Each milliliter ministered intramuscularly by hand of solution contains 0.5 milligram (mg) syringe or syringe dart at a suitable fenprostalene. dosage level depending upon the spe- (2) Each milliliter of solution con- cies. tains 0.25 mg fenprostalene. (2) Indications for use. For the immo- (b) Sponsor. See No. 054771 in bilization of wild and exotic animals. § 510.600(c) of this chapter for use of (3) Limitations. Do not use in domes- product described in paragraph (a)(1) as tic food-producing animals. Do not use in paragraph (e)(1) of this section; and

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for use of product described in para- (3) Limitations. Do not use in horses graph (a)(2) as in paragraph (e)(2) of intended for human consumption. Fed- this section. eral law restricts this drug to use by or (c) Related tolerances. See § 556.277 of on the order of a licensed veterinarian. this chapter. (d) Special considerations. Labeling [75 FR 59611, Sept. 28, 2010] shall bear the following statements: § 522.955 Florfenicol. Women of childbearing age, asthmatics, and persons with bronchial (a) Specifications. Each milliliter of and other respiratory problems should solution contains: exercise extreme caution when han- (1) 300 milligrams (mg) florfenicol in dling this product. It is readily ab- the inactive vehicles 2-pyrrolidone and sorbed through the skin and may cause triacetin. abortion and/or bronchiospasms. Acci- (2) 300 mg florfenicol in the inactive dental spillage on the skin should be vehicles n-methyl-2-pyrrolidone, pro- washed off immediately with soap and pylene glycol, and polyethylene glycol. water. (3) 300 mg florfenicol in the inactive (e) Conditions of use—(1) Cattle—(i) In- vehicles 2-pyrrolidone and glycerol for- dications for use and amount—(A) For mal. feedlot heifers to induce abortion when (b) Sponsors. See sponsor numbers in pregnant 150 days or less, administer 1 § 510.600(c) of this chapter: mg (2 milliliter (mL)) subcutaneously. (1) No. 000061 for use of product de- (B) For beef or nonlactating dairy scribed in paragraph (a)(1) as in para- cattle for estrus synchronization, ad- graph (d)(1)(i); and minister a single or two 1-mg (2-mL) (2) Nos. 000061 and 000859 for use of doses subcutaneously, 11 to 13 days product described in paragraph (a)(2) as apart. in paragraph (d)(1)(ii). (ii) Limitations. Federal law restricts (3) No. 055529 for use of product de- this drug to use by or on the order of a scribed in paragraph (a)(3) as in para- licensed veterinarian. graph (d)(1)(ii). (2) Swine—(i) Amount. Administer a (c) Related tolerances. See §§ 500.1410 single injection of 0.25 mg (1 mL) and 556.283 of this chapter. subcutaneously. (d) Conditions of use—(1) Beef and non- (ii) Indications for use. For the induc- lactating dairy cattle—(i) 300 mg per mil- tion of parturition in sows and gilts liliter (mL) florfenicol in the inactive pregnant at least 112 days. vehicles 2-pyrrolidone and triacetin: (iii) Limitations. Federal law restricts (A) Amount. 40 mg/kilogram (kg) body this drug to use by or on the order of a weight as a single subcutaneous injec- licensed veterinarian. tion. [79 FR 16188, Mar. 25, 2014] (B) Indications for use. For treatment of bovine respiratory disease (BRD) as- § 522.930 Firocoxib. sociated with Mannheimia haemolytica, (a) Specifications. Each milliliter of Pasteurella multocida, Histophilus somni, solution contains 20 milligrams (mg) and Mycoplasma bovis in beef and non- firocoxib. lactating dairy cattle. (b) Sponsors. See No. 050604 in (C) Limitations. Animals intended for § 510.600(c) of this chapter. human consumption must not be (c) Conditions of use in horses—(1) slaughtered within 44 days of treat- Amount. Administer 0.04 mg/pound (lb) ment. Do not use in female dairy cattle (0.09 mg/kilogram (kg)) of body weight 20 months of age or older. Use of (BW) intravenously, once daily, for up florfenicol in this class of cattle may to 5 days. If further treatment is need- cause milk residues. A withdrawal pe- ed, firocoxib oral paste can be adminis- riod has not been established in pre-ru- tered at a dosage of 0.045 mg/lb (0.1 mg/ minating calves. Do not use in calves kg) of BW for up to an additional 9 to be processed for veal. Federal law re- days of treatment. stricts this drug to use by or on the (2) Indications for use. For the control order of a licensed veterinarian. of pain and inflammation associated (ii) 300 mg/mL florfenicol in the inac- with osteoarthritis. tive vehicles n-methyl-2- pyrrolidone,

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propylene glycol, and polyethylene gly- (c) Tolerances. See §§ 556.283 and col, or in 2-pyrrolidone and glycerol 556.286 of this chapter. formal: (d) Conditions for use in cattle—(1) (A)(1) Amount. 20 mg/kg of body Amount. 40 mg florfenicol/kg body weight as an intramuscular injection. weight (BW) and 2.2 mg flunixin/kg BW A second dose should be administered (equivalent to 2 mL/15 kg BW or 6 mL/ 48 hours later. Alternatively, 40 mg/kg 100 lbs) once, by subcutaneous injec- of body weight as a single subcuta- tion. neous injection may be used. (2) Indications for use. For treatment (2) Indications for use. For treatment of bovine respiratory disease (BRD) as- of BRD associated with Mannheimia sociated with Mannheimia haemolytica, (Pasteurella) haemolytica, P. multocida, Pasteurella multocida, Histophilus somni, and Haemophilus somnus. For treatment and Mycoplasma bovis, and control of of bovine interdigital phlegmon (foot BRD-associated pyrexia in beef and rot, acute interdigital necrobacillosis, non-lactating dairy cattle. infectious pododermatitis) associated with Fusobacterium necrophorum and (3) Limitations. Animals intended for Bacteroides melaninogenicus. human consumption must not be (B)(1) Amount. 40 mg/kg of body slaughtered within 38 days of treat- weight as a single subcutaneous injec- ment. This drug product is not ap- tion. proved for use in female dairy cattle 20 (2) Indications for use. For control of months of age or older, including dry respiratory disease in cattle at high dairy cows. Use in these cattle may risk of developing BRD associated with cause drug residues in milk and/or in Mannheimia (Pasteurella) haemolytica, P. calves born to these cows. A with- multocida, and Haemophilus somnus. drawal period has not been established (C) Limitations. Animals intended for in preruminating calves. Do not use in human consumption must not be calves to be processed for veal. Federal slaughtered within 28 days of the last law restricts this drug to use by or on intramuscular treatment. Animals in- the order of a licensed veterinarian. tended for human consumption must not be slaughtered within 33 days of [75 FR 1275, Jan. 11, 2010, as amended at 75 FR 54018, Sept. 3, 2010; 79 FR 18158, Apr. 1, subcutaneous treatment. This product 2014] is not approved for use in female dairy cattle 20 months of age or older, in- § 522.960 Flumethasone injectable dos- cluding dry dairy cows. Use in these age forms. cattle may cause drug residues in milk and/or in calves born to these cows. A § 522.960a Flumethasone suspension. withdrawal period has not been estab- (a) Specifications. Each milliliter of lished in pre-ruminating calves. Do not suspension contains 2 milligrams (mg) use in calves to be processed for veal. Federal law restricts this drug to use of flumethasone. by or on the order of a licensed veteri- (b) Sponsor. See No. 054771 in narian. § 510.600(c) of this chapter. (2) [Reserved] (c) Conditions of use in horses—(1) Amount. Administer 6 to 10 mg by [73 FR 21041, Apr. 18, 2008, as amended at 74 intra-articular injection. Dosage is FR 66574, Dec. 16, 2009; 79 FR 18158, Apr. 1, limited to a single injection per week 2014; 79 FR 53136, Sept. 8, 2014; 80 FR 61296, Oct. 13, 2015; 80 FR 76386, Dec. 9, 2015] in any one synovial structure. (2) Indications for use. For use in the § 522.956 Florfenicol and flunixin. various disease states involving (a) Specifications. Each milliliter synovial structures (joints) of horses (mL) of solution contains 300 milli- where excessive synovial fluid of in- grams (mg) florfenicol and 16.5 mg flammatory origin is present and where flunixin (27.37 mg flunixin meglumine). permanent structural changes do not (b) Sponsor. See No. 000061 in exist. Such conditions include arthri- § 510.600(c) of this chapter for use as in tis, carpitis, and osselets. paragraph (d) of this section.

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(3) Limitations. Do not use in horses (iii) Limitations. Do not use in horses intended for human consumption. Fed- intended for human consumption. Fed- eral law restricts this drug to use by or eral law restricts this drug to use by or on the order of a licensed veterinarian. on the order of a licensed veterinarian. [79 FR 16188, Mar. 25, 2014] (2) Dogs—(i) Amount. Administer 0.0625 to 0.25 mg daily by intravenous, § 522.960b Flumethasone acetate solu- intramuscular, or subcutaneous injection. tion; 0.125 to 1.0 mg daily by intra- (a) Specifications. Each milliliter of lesional injection, depending on the solution contains 2 milligrams (mg) of size and location of the lesion; or 0.166 flumethasone acetate. to 1.0 mg daily by intra-articular injec- (b) Sponsor. See No. 054771 in tion, depending on the severity of the § 510.600(c) of this chapter. condition and the size of the involved (c) Conditions of use in dogs—(1) joint. Amount. Administer by intramuscular (ii) Indications for use. For use in the injection as follows: Dogs weighing up treatment of musculoskeletal condi- to 10 pounds (lbs): 2 mg; dogs weighing tions due to inflammation of muscles 10 to 25 lbs: 4 mg; dogs weighing over 25 or joints and accessory structures lbs: 8 mg. Dosage should be adjusted where permanent structural changes do according to the weight of the animal, not exist, e.g., arthritis, osteoarthritis, the severity of the symptoms, and the disc syndrome, and myositis (in septic response noted. Dosage by injection arthritis, appropriate antibacterial should not exceed 3 days of therapy. therapy should be concurrently admin- With chronic conditions intramuscular istered); certain acute and chronic therapy may be followed by oral ad- dermatoses of varying etiology to help ministration of flumethasone tablets control associated pruritus, irritation, at a daily dose of from 0.0625 to 0.25 mg and inflammation; otitis externa in per animal. conjunction with topical medication; (2) Indications for use. For use in cer- allergic states, e.g., hives, urticaria, tain acute and chronic canine and insect bites; and shock and shock- dermatoses of varying etiology to help like states by intravenous administra- control the pruritus, irritation, and in- tion. flammation associated with these con- (iii) Limitations. Federal law restricts ditions. this drug to use by or on the order of a (3) Limitations. Federal law restricts licensed veterinarian. this drug to use by or on the order of a (3) Cats—(i) Amount. Administer licensed veterinarian. 0.03125 to 0.125 mg daily by intravenous, [79 FR 16188, Mar. 25, 2014] intramuscular, or subcutaneous injection. § 522.960c Flumethasone solution. (ii) Indications for use. For use in the (a) Specifications. Each milliliter of treatment of certain acute and chronic solution contains 0.5 milligrams (mg) dermatoses of varying etiology to help of flumethasone. control associated pruritus, irritation, (b) Sponsor. See No. 054771 in and inflammation. § 510.600(c) of this chapter. (iii) Limitations. Federal law restricts (c) Conditions of use. It is used as fol- this drug to use by or on the order of a lows: licensed veterinarian. (1) Horses—(i) Amount. Administer 1.25 to 2.5 milligrams (mg) daily by in- [79 FR 16188, Mar. 25, 2014] travenous, intramuscular, or intra-ar- § 522.970 Flunixin. ticular injection. (ii) Indications for use. For use in the (a) Specifications. Each milliliter of treatment of musculoskeletal condi- solution contains flunixin meglumine tions due to inflammation, where per- equivalent to 50 milligrams (mg) manent structural changes do not flunixin. exist, e.g., bursitis, carpitis, osselets, (b) Sponsors. See sponsors in and myositis; and allergic states, e.g., § 510.600(c) of this chapter for use as in hives, urticaria, and insect bites. paragraph (e) of this section.

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(1) See Nos. 000061, 000859, 055529, (iii) Limitations. Swine must not be 057561, and 061623 for use as in para- slaughtered for human consumption graph (e) of this section. within 12 days of last treatment. (2) See No. 054771 for use as in para- [42 FR 39103, Aug. 2, 1977, as amended at 52 graph (e)(1) of this section. FR 7832, Mar. 13, 1987; 60 FR 54942, Oct. 27, (c) Related tolerances. See § 556.286 of 1995; 62 FR 22888, Apr. 28, 1997; 63 FR 38749, this chapter. July 20, 1998; 67 FR 9400, Mar. 1, 2002; 68 FR (d) Special considerations. Federal law 70701, Dec. 19, 2003; 69 FR 53618, Sept. 2, 2004; 69 FR 60308, Oct. 8, 2004; 70 FR 48868, Aug. 22, restricts this drug to use by or on the 2005; 70 FR 70998, Nov. 25, 2005; 71 FR 15564, order of a licensed veterinarian. Mar. 29, 2006; 71 FR 16222, Mar. 31, 2006; 73 FR (e) Conditions of use—(1) Horses—(i) 2809, Jan. 16, 2008; 73 FR 28037, May 15, 2008; Amount. 0.5 mg per pound (/lb) of body 74 FR 6994, Feb. 12, 2009; 74 FR 34236, July 15, weight per day, intravenously or 2009; 75 FR 13225, Mar. 19, 2010; 75 FR 76260, Dec. 8, 2010; 79 FR 16189, Mar. 25, 2014; 82 FR intramuscularly, for up to 5 days. 43484, Sept. 18, 2017] (ii) Indications for use. For alleviation of inflammation and pain associated § 522.995 Fluprostenol. with musculoskeletal disorders, and al- (a) Specifications. Each milliliter of leviation of visceral pain associated solution contains fluprostenol sodium with colic. equivalent to 50 micrograms (μg) of (iii) Limitations. Do not use in horses fluprostenol. intended for human consumption. (b) Sponsor. See No. 000859 in (2) Cattle—(i) Amounts and indications § 510.600(c) of this chapter. for use—(A) Administer 1.1 to 2.2 mg/ (c) Conditions of use in horses—(1) kilogram (kg) (0.5 to 1.0 mg/lb) of body Amount. Administer 0.55 μg fluprostenol weight per day intravenously, as a sin- per kilogram of body weight by gle dose or divided into two doses ad- intramuscular injection. ministered at 12-hour intervals, for up (2) Indications for use. For use in to 3 days for control of pyrexia associ- mares for its luteolytic effect to con- ated with bovine respiratory disease trol the timing of estrus in estrous cy- and endotoxemia or for control of in- cling and in clinically anestrous mares flammation in endotoxemia. that have a corpus luteum. (B) Administer 2.2 mg/kg (1.0 mg/lb) (3) Limitations. Do not use in horses intended for human consumption. Fed- of body weight once intravenously for eral law restricts this drug to use by or control of pyrexia associated with on the order of a licensed veterinarian. acute bovine mastitis. (ii) Limitations. Approved only for in- [79 FR 16189, Mar. 25, 2014] travenous administration in cattle. § 522.1002 Follicle stimulating hor- Intramuscular administration has re- mone. sulted in violative residues in the edible tissues of cattle sent to slaughter. (a)(1) Specifications. Each package Cattle must not be slaughtered for contains 2 vials. One vial contains dry, human consumption within 4 days of powdered, porcine pituitary gland equivalent to 75 units (NIH-FSH-S1) of last treatment. Milk that has been follicle stimulating hormone. The taken during treatment and for 36 other vial contains 10 milliliters of hours after the last treatment must aqueous diluent. not be used for food. Do not use in dry (2) Sponsor. See No. 052923 in dairy cows. A withdrawal period has § 510.600(c) of this chapter. not been established for use in (3) Conditions of use. (i) Dosage. 12.5 preruminating calves. Do not use in units of follicle stimulating hormone calves to be processed for veal. twice a day for 3 days (a total of 75 (B) [Reserved] units). To effect regression of the cor- (3) Swine—(i) Amount. Administer 2.2 pus luteum, prostaglandin should be mg/kg (1.0 mg/lb) of body weight as a given with the 5th dose. single intramuscular injection. (ii) Indications for use. For induction (ii) Indications for use. For the control of superovulation in cows for proce- of pyrexia associated with swine res- dures requiring the production of mul- piratory disease. tiple ova at a single estrus.

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(iii) Limitations. For intramuscular (b) Sponsors. See sponsors in use in cows that are not pregnant and § 510.600(c) of this chapter for use of have a normal corpus luteum. Federal products described in paragraph (a) of law restricts this drug to use by or on this section for use as in paragraph (d) the order of a licensed veterinarian. of this section. (b)(1) Specifications—(i) Single pack. (1) No. 000010 as described in para- Each package contains 2 vials. One vial graph (a)(1) of this section for use as in contains 700 international units (IU) paragraphs (d)(1) and (d)(2)(ii) of this porcine-pituitary-derived follicle stim- section. ulating hormone (FSH) equivalent to (2) No. 061623 as described in para- 400 milligrams NIH–FSH–P1, as a dry graph (a)(2) of this section for use as in powder. The other vial contains 20 mil- paragraph (d)(2)(ii) of this section. liliters (mL) of bacteriostatic sodium (3) No. 000859 as described in para- chloride injection. When constituted, graph (a)(2) for use as in paragraphs each milliliter of solution contains 35 (d)(1), (d)(2)(i), and (d)(3) of this sec- IU FSH. tion. (ii) Dual pack. Each package contains (4) No. 000061 as described in para- 2 vials. Each vial contains 700 inter- graph (a)(2) for use as in paragraphs national units (IU) porcine-pituitary- (d)(1), (d)(2)(iii), and (d)(3) of this sec- derived FSH equivalent to 400 milli- tion. grams NIH–FSH–P1, as a dry powder. (c) Special considerations. Federal law Constitute with 20 mL bacteriostatic restricts this drug to use by or on the sodium chloride injection, using strict order of a licensed veterinarian. aseptic technique. When constituted, (d) Conditions of use—(1) Dogs and each milliliter of solution contains 35 cats—(i) Amount. 1.25 to 2.5 mg per IU FSH. pound (/lb) body weight once or twice (2) Sponsor. See No. 017030 in daily, intramuscularly or intra- § 510.600(c) of this chapter. venously. (3) Conditions of use—(i) Dosage. Ad- (ii) Indications for use. For the treat- minister 2.5 mL (87.5 IU) ment of edema (pulmonary congestion, intramuscularly, twice daily at 12-hour ascites) associated with cardiac insuffi- intervals, for 4 consecutive days. In ciency and acute noninflammatory tis- conjunction with the 6th dose, admin- sue edema. ister an approved prostaglandin prod- (2) Horses—(i) Amount. 250 to 500 mg uct for cattle (cloprostenol sodium or per animal once or twice daily, dinoprost tromethamine), using the la- intramuscularly or intravenously. beled dosage and administration in- (A) Indications for use. For the treat- structions to cause luteolysis and in- ment of edema (pulmonary congestion, duce estrus. See § 522.460 for use of ascites) associated with cardiac insuffi- cloprostenol sodium or § 522.690 for use ciency, and acute noninflammatory tis- of dinoprost tromethamine. sue edema. (ii) Indications for use. For the induc- (B) Limitations. Do not use in horses tion of superovulation in beef and dairy intended for human consumption. heifers and cows. (ii) Amount. 0.5 mg/lb body weight (iii) Limitations. Federal law restricts once or twice daily, intramuscularly or this drug to use by or on the order of a intravenously. licensed veterinarian. (A) Indications for use. For treatment [58 FR 47377, Sept. 9, 1993, as amended at 62 of acute noninflammatory tissue FR 62242, Nov. 21, 1997; 76 FR 2808, Jan. 18, edema. 2011; 79 FR 53136, Sept. 8, 2014; 79 FR 74020, (B) Limitations. Do not use in horses Dec. 15, 2014; 82 FR 21690, May 10, 2017; 82 FR intended for human consumption. 43484, Sept. 18, 2017] (iii) Amount. 250 to 500 mg/animal once or twice daily, intramuscularly or § 522.1010 Furosemide. intravenously. (a) Specifications—(1) Each milliliter (A) Indications for use. For the treat- (mL) of solution contains 50 milligrams ment of edema (pulmonary congestion, (mg) furosemide monoethanolamine. ascites) associated with cardiac insuffi- (2) Each mL of solution contains 50 ciency, and acute noninflammatory tis- mg furosemide diethanolamine. sue edema.

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(B) Limitations. Do not use in horses law restricts this drug to use by or on intended for human consumption. the order of a licensed veterinarian. (3) Cattle—(i) Amount. 500 mg/animal (2) [Reserved] once daily, intramuscularly or intra- [76 FR 57906, Sept. 19, 2011, as amended at 77 venously; or 250 mg/animal twice daily FR 26162, May 3, 2012] at 12-hour intervals, intramuscularly or intravenously. § 522.1020 Gelatin. (ii) For the treat- Indications for use. (a) Specifications. Each 100 milliliters ment of physiological parturient contains 8 grams of gelatin in a 0.85 edema of the mammary gland and asso- percent sodium chloride solution. ciated structures. (b) Sponsor. See No. 054771 in (iii) Limitations. Treatment not to ex- § 510.600(c) of this chapter. ceed 48 hours post-parturition. Milk (c) Conditions of use—(1) Amount. The taken during treatment and for 48 exact dosage to be administered must hours (four milkings) after the last be determined after evaluating the ani- treatment must not be used for food. mal’s condition and will vary according Cattle must not be slaughtered for food to the size of the animal and the degree within 48 hours following last treat- of shock. A suggested dosage range for ment. small animals such as dogs is 4 to 8 [66 FR 47961, Sept. 17, 2001, as amended at 67 cubic centimeters per pound body FR 18086, Apr. 15, 2002; 68 FR 59881, Oct. 20, weight. The suggested dosage range for 2003; 69 FR 17585, Apr. 5, 2004; 71 FR 39548, large animals such as sheep, calves, July 13, 2006; 74 FR 61516, Nov. 25, 2009; 76 FR cows, or horses is 2 to 4 cubic centi- 17338, Mar. 29, 2011; 78 FR 17597, Mar. 22, 2013; meters per pound of body weight. 79 FR 16189, Mar. 25, 2014] (2) Indications for use. For use to re- § 522.1014 Gamithromycin. store circulatory volume and maintain blood pressure in animals being treated (a) Specifications. Each milliliter for shock. (mL) of solution contains 150 milli- (3) Limitations. Federal law restricts grams (mg) gamithromycin. this drug to use by or on the order of a (b) Sponsor. See No. 050604 in licensed veterinarian. § 510.600(c) of this chapter. (c) Related tolerances. See § 556.292 of [79 FR 16189, Mar. 25, 2014] this chapter. (d) Conditions of use—(1) Cattle—(i) § 522.1044 Gentamicin. Amount. Administer 6 mg/kilogram of (a) Specifications. Each milliliter of body weight (2 mL per 110 pounds) one solution contains gentamicin sulfate time by subcutaneous injection in the equivalent to 5, 50, or 100 milligrams neck. (mg) gentamicin. (ii) Indications for use. For the treat- (b) Sponsors. See sponsors in ment of bovine respiratory disease § 510.600(c) of this chapter for use as in (BRD) associated with Mannheimia paragraph (d) of this section. haemolytica, Pasteurella multocida, (1) No. 000061 for use of 5 mg per mil- Histophilus somni, and Mycoplasma bovis liliter (/mL) solution in swine as in in beef and non-lactating dairy cattle; paragraph (d)(4), 50 mg/mL solution in and for the control of respiratory dis- dogs and cats as in paragraph (d)(1), 50 ease in beef and non-lactating dairy mg/mL and 100 mg/mL solution in cattle at high risk of developing BRD chickens and turkeys as in paragraphs associated with M. haemolytica and P. (d)(2) and (d)(3) of this section. multocida. (2) No. 058005 for use of 5 mg/mL solu- (iii) Limitations. Cattle intended for tion in swine as in paragraph (d)(4) of human consumption must not be this section. slaughtered within 35 days from the (3) No. 054628 for use of 50 mg/mL so- last treatment. Do not use in female lution in dogs as in paragraph (d)(5) of dairy cattle 20 months of age or older. this section. A withdrawal period has not been es- (4) Nos. 016592 and 061623 for use of 100 tablished for this product in mg/mL solution in turkeys as in para- preruminating calves. Do not use in graph (d)(2) and in chickens as in para- calves to be processed for veal. Federal graph (d)(3) of this section.

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(c) Related tolerances. See § 556.300 of (iii) Limitations. For use in day-old this chapter. chickens only. Administer aseptically, (d) Conditions of use—(1) Dogs and injecting the diluted product cats—(i) Amount. Two milligrams of subcutaneously in the neck. Do not gentamicin per pound of body weight, slaughter treated animals for food for twice daily on the first day, once daily at least 5 weeks after treatment. thereafter, using a 50 milligram-per- (4) Swine—(i) Amount. 5 milligrams of milliliter solution. gentamicin as a single intramuscular (ii) Indications for use—(a) Dogs. For dose using 5 milligram-per-milliliter the treatment of infections of urinary solution. tract (cystitis, nephritis), respiratory (ii) Indications for use. In piglets up to tract (tonsillitis, pneumonia, 3 days old for treatment of porcine tracheobronchitis), skin and soft tissue colibacillosis caused by strains of E. coli sensitive to gentamicin. (pyodermatitis, wounds, lacerations, (iii) Limitations. For single peritonitis). intramuscular dose in pigs up to 3 days (b) Cats. For the treatment of infec- of age only. Do not slaughter treated tions of urinary tract (cystitis, nephri- animals for food for at least 40 days fol- tis), respiratory tract (pneumonitis, lowing treatment. pneumonia, upper respiratory tract in- (5) Dogs—(i) Amount. 2 milligrams of fections), skin and soft tissue (wounds, gentamicin per pound of body weight, lacerations, peritonitis), and as sup- twice daily on the first day, then once portive therapy for secondary bacterial daily. infections associated with (ii) Indications for use. For use in the panleucopenia. treatment of urinary tract infections (iii) Limitations. Administer (cystitis) caused by Proteus mirabilis, intramuscularly or subcutaneously. If Escherichia coli, and Staphylococcus response is not noted after 7 days, the aureus. antibiotic sensitivity of the infecting (iii) Limitations. Administer organism should be retested. Federal intramuscularly or subcutaneously. If law restricts this drug to use by or on no improvement is seen after 3 days, the order of a licensed veterinarian. treatment should be discontinued and (2) Turkeys—(i) Amount. One milli- the diagnosis reevaluated. Treatment gram of gentamicin per 0.2 milliliter not to exceed 7 days. Federal law re- dose, using the 50- or 100-milligrams- stricts this drug to use by or on the per-milliliter product diluted with order of a licensed veterinarian. sterile saline to a concentration of 5 [43 FR 1942, Jan. 13, 1978, as amended at 48 milligrams-per-milliliter. FR 791, Jan. 7, 1983; 51 FR 15606, Apr. 25, 1986; (ii) Indications for use. As an aid in 52 FR 7832, Mar. 13, 1987; 53 FR 40727, Oct. 18, the prevention of early mortality due 1988; 60 FR 29985, June 7, 1995; 61 FR 24441, to Arizona paracolon infections suscep- May 15, 1996; 62 FR 45157, Aug. 26, 1997; 63 FR tible to gentamicin. 59714, Nov. 5, 1998; 63 FR 68182, Dec. 10, 1998; 65 FR 45877, July 26, 2000; 71 FR 76901, Dec. 22, (iii) Limitations. For 1- to 3-day old 2006; 78 FR 17597, Mar. 22, 2013; 78 FR 21060, turkey poults. Administer Apr. 9, 2013; 79 FR 21127, Apr. 15, 2014; 81 FR subcutaneously in the neck. Injected 22524, Apr. 18, 2016] poults must not be slaughtered for food for at least 9 weeks after treatment. § 522.1055 Gleptoferron. (3) Chickens—(i) Amount. 0.2 milli- (a) Specifications. Each milliliter gram of gentamicin per 0.2 milliliter (mL) contains the equivalent of 200 dose, using the 50- or 100-milligrams- milligrams of elemental iron as per-milliliter product diluted with gleptoferron, a complex of ferric hy- sterile saline to a concentration of 1.0 droxide and dextran glucoheptonic milligram-per-milliliter. acid. (ii) Indications for use. In day-old (b) Sponsors. See No. 013744 in chickens, for prevention of early mor- § 510.600(c) of this chapter. tality caused by Escherichia coli. Sal- (c) Conditions of use in swine—(1) Indi- monella typhimurium, and Pseudomonas cations for use and amounts. (i) Preven- aeruginosa that are susceptible to tion of anemia due to iron deficiency: gentamicin. Administer 1 mL (200 mg iron) per pig

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by intramuscular injection on or before (4) No. 054771 for use of the 50-μg/mL 3 days of age. product described in paragraph (a)(4) as (ii) Treatment of anemia due to iron in paragraphs (d)(1)(iii), (d)(1)(vi), and deficiency: Administer 1 mL (200 mg (d)(2) of this section. iron) per pig by intramuscular injec- (c) Special considerations. Concurrent tion as soon as signs of deficiency ap- luteolytic drug use is approved as fol- pear. lows: (2) [Reserved] (1) Cloprostenol injection for use as [81 FR 59134, Aug. 29, 2016, as amended at 82 in paragraph (d)(1)(iv) of this section as FR 11508, Feb. 24, 2017; 82 FR 21690, May 10, provided by No. 000061 in § 510.600(c) of 2017] this chapter. (2) Cloprostenol injection for use as § 522.1066 Glycopyrrolate. in paragraph (d)(1)(v) of this section as (a) Specifications. Each milliliter of provided by No. 000061 or No. 068504 in solution contains 0.2 milligram § 510.600(c) of this chapter. glycopyrrolate. (3) Dinoprost injection for use as in (b) Sponsors. See Nos. 054771 and paragraph (d)(1)(vi) of this section as 069043 in § 510.600(c) of this chapter. provided by No. 054771 in § 510.600(c) of (c) Conditions of use in dogs and cats— this chapter. (1) Amount. 5 micrograms per pound of (d) Conditions of use in cattle—(1) Indi- body weight (0.25 milliliter per 10 cations for use and amounts—(i) For the pounds of body weight) by intravenous, treatment of ovarian follicular cysts in intramuscular, or subcutaneous injec- dairy cattle: Administer 86 μg tion in dogs or by intramuscular injec- gonadorelin by intramuscular or intra- tion in cats. venous injection. (2) Indications for use. As a (ii) For the treatment of ovarian fol- preanesthetic agent. licular cysts in dairy cattle: Admin- (3) Limitations. Federal law restricts ister 100 μg gonadorelin by this drug to use by or on the order of a intramuscular or intravenous injec- licensed veterinarian. tion. [71 FR 64451, Nov. 2, 2006, as amended at 78 (iii) For the treatment of ovarian fol- FR 17597, Mar. 22, 2013; 79 FR 16189, Mar. 25, licular cysts in cattle: Administer 100 2014; 81 FR 17608, Mar. 30, 2016] μg gonadorelin by intramuscular injection. § 522.1077 Gonadorelin. (iv) For use with cloprostenol injec- (a) Specifications. Each milliliter tion to synchronize estrous cycles to (mL) of solution contains: allow for fixed-time artificial insemi- (1) 43 micrograms (μg) of gonadorelin nation (FTAI) in lactating dairy cows: as gonadorelin acetate; Administer to each cow 86 μg (2) 100 μg of gonadorelin as gonadorelin by intramuscular injec- gonadorelin acetate; tion, followed 6 to 8 days later by 500 μg (3) 50 μg of gonadorelin as cloprostenol by intramuscular injec- gonadorelin diacetate tetrahydrate; or tion, followed 30 to 72 hours later by 86 (4) 50 μg of gonadorelin as μg gonadorelin by intramuscular injec- gonadorelin hydrochloride. tion. (b) Sponsors. See sponsor numbers in (v) For use with cloprostenol injec- § 510.600(c) of this chapter. tion to synchronize estrous cycles to (1) No. 000061 for use of the 43-μg/mL allow for fixed-time artificial insemi- product described in paragraph (a)(1) as nation (FTAI) in lactating dairy cows in paragraphs (d)(1)(i), (d)(1)(iv), and and beef cows: Administer to each cow (d)(2) of this section. 100 μg gonadorelin by intramuscular in- (2) No. 068504 for use of the 100-μg/mL jection, followed 6 to 8 days later by 500 product described in paragraph (a)(2) as μg cloprostenol by intramuscular injec- in paragraphs (d)(1)(ii), (d)(1)(v), and tion, followed 30 to 72 hours later by 100 (d)(2) of this section. μg gonadorelin by intramuscular injec- (3) Nos. 050604 and 061623 for use of tion. the 50-μg/mL product described in para- (vi) For use with dinoprost injection graph (a)(3) as in paragraphs (d)(1)(ii) to synchronize estrous cycles to allow and (d)(2) of this section. fixed-time artificial insemination

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(FTAI) in lactating dairy cows: Admin- (b) Sponsors. See sponsors in ister to each cow 100 to 200 μg § 510.600(c) of this chapter for use as in gonadorelin by intramuscular injec- paragraph (d) of this section. tion, followed 6 to 8 days later by 25 mg (1) Nos. 000402 and 054771 for use as in dinoprost by intramuscular injection, paragraphs (d)(1)(i)(A), (d)(1)(i)(B) and followed 30 to 72 hours later by 100 to (d)(1)(i)(C) of this section. 200 μg gonadorelin by intramuscular in- (2) [Reserved] jection. (3) No. 000061 for use as in paragraphs (2) Limitations. Federal law restricts (d)(1)(i)(A) and (d)(2) of this section. this drug to use by or on the order of a (c) Related tolerances. See § 556.304 of licensed veterinarian. this chapter. (d) Conditions of use—(1) Cattle—(i) [80 FR 34279, June 16, 2015, as amended at 81 Amount. As a single dose. Dosage may FR 36789, June 8, 2016] be repeated in 14 days if the animal’s § 522.1079 Serum gonadotropin and behavior or examination of the ovaries chorionic gonadotropin. per rectum indicates retreatment. (A) 10,000 USP units by (a) Specifications. Each dose consists intramuscular injection. of 400 international units (I.U.) serum (B) 500 to 2,500 USP units by gonadotropin and 200 I.U. chorionic intrafollicular injection. gonadotropin as a freeze-dried powder (C) 2,500 to 5,000 USP units by intra- to be reconstituted with 5 milliliters of venous injection. sterile aqueous diluent. (ii) Indications for use. For parenteral (b) Sponsor. See No. 000061 in use in cows for treatment of nympho- § 510.600(c) of this chapter. mania (frequent or constant heat) due (c) Conditions of use in swine—(1) to cystic ovaries. Amount. 400 I.U. serum gonadotropin (iii) Limitations. Federal law restricts with 200 I.U. chorionic gonadotropin this drug to use by or on the order of a per 5 milliliters dose per animal. licensed veterinarian. (2) Indications for use. (i) Gilts. For in- (2) Finfish—(i) Amount. 50 to 510 IU duction of fertile estrus (heat) in per pound of body weight for males, 67 healthy prepuberal (noncycling) gilts. to 1,816 IU per pound of body weight for (ii) Sows. For induction of estrus in females, by intramuscular injection. healthy weaned sows experiencing de- Up to three doses may be administered. layed return to estrus. (ii) Indications for use. An aid in im- (3) Limitations. For subcutaneous use proving spawning function in male and only. female brood finfish. (i) Gilts. For use only in gilts over 51⁄2 (iii) Limitations. In fish intended for months of age and weighing at least 85 human consumption, the total dose ad- kilograms (187 pounds). ministered per fish (all injections com- (ii) Sows. Delayed return to estrus is bined) should not exceed 25,000 IU most prevalent after the first litter. chorionic gonadotropin. Federal law re- The effectiveness has not been estab- stricts this drug to use by or on the lished after later litters. Delayed re- order of a licensed veterinarian. turn to estrus often occurs during periods of adverse environmental condi- [74 FR 61516, Nov. 25, 2009, as amended at 76 tions, and sows mated under such con- FR 17778, Mar. 31, 2011; 77 FR 55414, Sept. 10, 2012; 79 FR 16189, Mar. 25, 2014] ditions may farrow smaller than normal litters. EFFECTIVE DATE NOTE: At 83 FR 13635, Mar. 30, 2018, § 522.1081 was amended by removing [55 FR 1405, Jan. 16, 1990, as amended at 58 ‘‘Nos. 000402 and 054771’’ and in its place add- FR 52222, Oct. 7, 1993; 74 FR 61516, Nov. 25, ing ‘‘No. 054771’’, effective Apr. 9, 2018. 2009] § 522.1083 Gonadotropin releasing fac- § 522.1081 Chorionic gonadotropin. tor analog-diphtheria toxoid con- (a) Specifications. Each vial contains jugate. 5,000, 10,000 or 20,000 USP units of (a) Specifications. Each milliliter of lyophilized powder for constitution solution contains 0.2 milligrams (mg) with accompanying diluent to a 10-mil- gonadotropin releasing factor analog- liliter solution. diphtheria toxoid conjugate.

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(b) Sponsor. See No. 054771 in (3) Limitations. Do not use in horses § 510.600(c) of this chapter. intended for human consumption. Fed- (c) Conditions of use in swine—(1) eral law restricts this drug to use by or Amount. Administer 0.4 mg (2 milliliter on the order of a licensed veterinarian. (mL)) by subcutaneous injection no [79 FR 16189, Mar. 25, 2014] earlier than 9 weeks of age. A second subcutaneous injection of 0.4 mg (2 mL) § 522.1125 Hemoglobin glutamer-200 should be administered at least 4 weeks (bovine). after the first dose. (a) Specifications. Each 125 milliliter (2) Indications for use. For the tem- bag contains 13 grams per deciliter of porary immunological castration (sup- polymerized hemoglobin of bovine ori- pression of testicular function) and re- gin in modified Lactated Ringer’s Solu- duction of boar taint in intact male tion. It is a sterile, clear, dark purple pigs intended for slaughter. solution. (3) Federal law restricts Limitations. (b) Sponsor. See No. 063075 in this drug to use by or on the order of a § 510.600(c) of this chapter. licensed veterinarian. Pigs should be (c) [Reserved] slaughtered no earlier than 3 weeks (d) Conditions of use—(1) Amount. One- and no later than 10 weeks after the time dose of 10 to 30 milliliters per second dose. kilogram of body weight administered [76 FR 27889, May 13, 2011, as amended at 77 intravenously at a rate of up to 10 mil- FR 4227, Jan. 27, 2012; 79 FR 16189, Mar. 25, liliters per kilogram per hour. 2014] (2) Indications for use. For the treatment of anemia in dogs by increasing § 522.1085 Guaifenesin powder for in- systemic oxygen content (plasma he- jection. moglobin concentration) and improv- (a) Specifications. The product is a ing the clinical signs associated with sterile powder containing guaifenesin. anemia, regardless of the cause of ane- A solution is prepared by dissolving the mia (hemolysis, blood loss, or ineffec- drug in sterile water for injection to tive erythropoiesis). make a solution containing 50 milli- (3) Limitations. Federal law restricts grams of guaifenesin per milliliter of this drug to use by or on the order of a solution. licensed veterinarian. (b) Sponsors. See Nos. 037990 and 054771 in § 510.600(c) of this chapter. [63 FR 11598, Mar. 10, 1998, as amended at 65 (c) Conditions of use in horses—(1) FR 20732, Apr. 18, 2000; 79 FR 16189, Mar. 25, 2014] Amount. Administer 1 milliliter of prepared solution per pound of body § 522.1145 Hyaluronate. weight by rapid intravenous infusion. (a)(1) Specifications. Each milliliter of (2) Indications for use. For use as a sterile aqueous solution contains 10 muscle relaxant. (3) Limitations. Do not use in horses milligrams of hyaluronate sodium. (2) See 054771 in § 510.600(c). intended for human consumption. Fed- Sponsor. (3) Conditions of use—(i) Amount. eral law restricts this drug to use by or Small and medium-size joints (carpal, on the order of a licensed veterinarian. fetlock): 20 mg; larger joint (hock): 40 [79 FR 16189, Mar. 25, 2014] mg. Treatment may be repeated at weekly intervals for a total of three § 522.1086 Guaifenesin solution. treatments. (a) Specifications. Each milliliter of (ii) Indications for use. Treatment of solution contains 50 milligrams (mg) of joint dysfunction in horses due to non- guaifenesin and 50 mg of dextrose. infectious synovitis associated with (b) Sponsors. See Nos. 000859 and equine osteoarthritis. 037990 in § 510.600(c) of this chapter. (iii) Limitations. Do not use in horses (c) Conditions of use in horses—(1) intended for human consumption. Fed- Amount. Administer 1 milliliter per eral law restricts this drug to use by or pound of body weight by rapid intra- on the order of a licensed veterinarian. venous infusion. (b)(1) Specifications. Each milliliter of (2) Indications for use. For use as a sterile aqueous solution contains 5 mil- skeletal muscle relaxant. ligrams of hyaluronate sodium.

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(2) Sponsor. See 054771 in § 510.600(c) of (2) Sponsors. See sponsors in this chapter. § 510.600(c) of this chapter: (3) Conditions of use—(i) Amount. (i) No. 050604 for use of products de- Small and medium-size joints (carpal, scribed in paragraph (e)(1) as in para- fetlock): 10 mg; larger joint (hock): 20 graph (e)(3) of this section. mg. Treatment may be repeated at (ii) No. 017030 for use of product de- weekly intervals for a total of four scribed in paragraph (e)(1)(i) as in para- treatments. graph (e)(3) of this section. (ii) Indications for use. Treatment of (3) Conditions of use—(i) Amount. 20 joint dysfunction in horses due to non- mg of the product described in para- infectious synovitis associated with graph (e)(1)(i) of this section by intra- equine osteoarthritis. articular injection into the carpus or (iii) Limitations. Do not use in horses fetlock; or 40 mg of the product de- intended for human consumption. Fed- scribed in paragraph (e)(1)(i) or (e)(1)(ii) eral law restricts this drug to use by or of this section by slow intravenous in- on the order of a licensed veterinarian. jection into the jugular vein. Treat- (c)(1) Specifications. Each milliliter of ment may be repeated at weekly inter- sterile aqueous solution contains 10 vals for a total of three treatments. milligrams of hyaluronate sodium. (ii) Indications for use. For treatment (2) Sponsor. See No. 000010 in of carpal or fetlock joint dysfunction § 510.600(c) of this chapter. due to noninfectious synovitis associ- (3) Conditions of use—(i) Amount. ated with equine osteoarthritis. Small and medium-size joints (carpal, (iii) Limitations. Do not use in horses fetlock): 20 mg. Treatment may be re- intended for human consumption. Fed- peated after 1 or more weeks but not to eral law restricts this drug to use by or exceed 2 injections per week for a total on the order of a licensed veterinarian. of 4 weeks. (f)(1) Specifications. Each milliliter of (ii) Indications for use. For the intra- sterile aqueous solution contains 11 articular treatment of carpal or fet- milligrams of hyaluronate sodium. lock joint dysfunction in horses due to (2) Sponsor. See 060865 in § 510.600(c). acute or chronic, non-infectious syno- (3) Conditions of use—(i) Amount. vitis associated with equine osteo- Small and medium-size joints (carpal, arthritis. fetlock): 22 mg; larger joint (hock): 44 (iii) Limitations. Do not use in horses mg. Treatment may be repeated at intended for human consumption. Fed- weekly intervals for a total of three eral law restricts this drug to use by or treatments. on the order of a licensed veterinarian. (ii) Indications for use. Treatment of (d)(1) Specifications. Each milliliter of joint dysfunction in horses due to nonsterile aqueous solution contains 10 infectious synovitis associated with milligrams of hyaluronate sodium. equine osteoarthritis. (2) Sponsor. See 000061 in § 510.600(c) of (iii) Limitations. Do not use in horses this chapter. intended for human consumption. Fed- (3) Conditions of use—(i) Amount. 50 eral law restricts this drug to use by or milligrams in carpal and fetlock joints. on the order of a licensed veterinarian. (ii) Indications for use. For treatment [49 FR 45124, Nov. 15, 1984, as amended at 51 of equine carpal and fetlock joint dys- FR 11438, Apr. 3, 1986; 51 FR 25032, July 10, function caused by traumatic and/or 1986; 53 FR 19773, May 31, 1988; 53 FR 22297, degenerative joint disease of mild to June 15, 1988; 56 FR 50814, Oct. 9, 1991; 57 FR moderate severity. 2837, Jan. 24, 1992; 59 FR 33198, June 28, 1994; 61 FR 59003, Nov. 20, 1996; 63 FR 59216, Nov. 3, (iii) Limitations. Do not use in horses 1998; 71 FR 1689, Jan. 11, 2006; 71 FR 39204, intended for human consumption. Fed- July 12, 2006; 75 FR 1274, Jan. 11, 2010; 75 FR eral law restricts this drug to use by or 10167, Mar. 5, 2010; 78 FR 73698, Dec. 9, 2013; 79 on the order of a licensed veterinarian. FR 16189, Mar. 25, 2014; 79 FR 74020, Dec. 15, (e)(1) Specifications. Each milliliter of 2014; 80 FR 34279, June 16, 2015] solution contains: (i) 10 milligrams (mg) hyaluronate § 522.1150 Hydrochlorothiazide. sodium; or (a) Specifications. Each milliliter of (ii) 10 mg hyaluronate sodium with solution contains 25 milligrams of benzyl alcohol as a preservative. hydrochlorothiazide.

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(b) Sponsor. See No. 050604 in eral law restricts this drug to use by or § 510.600(c) of this chapter. on the order of a licensed veterinarian. (c) Conditions of use—(1) Amount. 5 to [79 FR 16190, Mar. 25, 2014] 10 milliliters (125 to 250 milligrams) intravenously or intramuscularly once or § 522.1156 Imidocarb solution. twice a day. After onset of diuresis, (a) Specifications. Each milliliter of treatment may be continued with an solution contains 120 milligrams (mg) orally administered maintenance dose. of imidocarb dipropionate. (2) Indications for use. For use in cat- (b) Sponsor. See No. 000061 in tle as an aid in the treatment of § 510.600(c) of this chapter. postparturient udder edema. (c) Conditions of use in dogs—(1) (3) Limitations. Milk taken from dairy Amount. Administer 6.6 mg per kilo- animals during treatment and for 72 gram (3 mg per pound) of body weight hours (6 milkings) after the latest by intramuscular injection. Repeat the treatment must not be used for food. dose after 2 weeks for a total of two Federal law restricts this drug to use treatments. by or on the order of a licensed veteri- (2) Indications for use. For the treat- narian. ment of clinical signs of babesiosis and/ [43 FR 59058, Dec. 19, 1978, as amended at 62 or demonstrated Babesia organisms in FR 63271, Nov. 28, 1997; 79 FR 16190, Mar. 25, the blood. 2014] (3) Limitations. Federal law restricts this drug to use by or on the order of a § 522.1155 Imidocarb powder for injec- licensed veterinarian. tion. [79 FR 16190, Mar. 25, 2014] (a) Specifications. The product is a sterile powder containing imidocarb § 522.1160 Insulin. dipropionate. Each milliliter of con- (a) Specifications—(1) Each milliliter stituted solution contains 100 milli- (mL) of porcine insulin zinc suspension grams (mg) of imidocarb base. contains 40 international units (IU) of (b) Sponsor. See No. 000061 in insulin. § 510.600(c) of this chapter. (2) Each mL of protamine zinc recom- (c) Special considerations. Imidocarb binant human insulin suspension con- dipropionate is sold only under permit tains 40 IU of insulin. issued by the Director of the National (b) Sponsors. See sponsors in § 510.600 Program Planning Staff, Veterinary of this chapter for use as in paragraph Services, Animal and Plant Health In- (c) of this section. spection Service, U.S. Department of (1) No. 000061 for use of product de- Agriculture, to licensed or full-time scribed in paragraph (a)(1) of this sec- State, Federal, or military veterinar- tion as in paragraphs (c)(1), (c)(2)(i)(A), ians. (c)(2)(ii), and (c)(2)(iii) of this section. (d) Conditions of use in horses and ze- (2) No. 000010 for use of product de- bras—(1) Amount. For Babesia caballi in- scribed in paragraph (a)(2) of this sec- fections, administer 2 mg of imidocarb tion as in paragraphs (c)(2)(i)(B), base per kilogram of body weight by (c)(2)(ii), and (c)(2)(iii) of this section. intramuscular injection in the neck re- (c) Conditions of use—(1) Dogs—(i) gion, repeating dosage once after 24 Amount. Administer an initial once- hours. For Babesia equi infections, ad- daily dose of 0.5 IU per kilogram of minister 4 mg of imidocarb base per body weight by subcutaneous injection kilogram of body weight by concurrently with or right after a intramuscular injection in the neck re- meal. Adjust this once-daily dose at ap- gion, repeating dosage four times at 72- propriate intervals based on clinical hour intervals. signs, urinalysis results, and glucose (2) Indications for use. For the treat- curve values until adequate glycemic ment of babesiosis (piroplasmosis) control has been attained. Twice-daily caused by Babesia caballi and Babesia therapy should be initiated if the dura- equi. tion of insulin action is determined to (3) Limitations. Do not use in horses be inadequate. If twice-daily treatment intended for human consumption. Fed- is initiated, the two doses should be 25

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percent less than the once daily dose (1) Nos. 000859 and 042552 for use of required to attain an acceptable nadir. product described in paragraph (a)(1)(i) (ii) Indications for use. For the reduc- of this section as follows: tion of hyperglycemia and hyper- (i) For prevention of iron deficiency glycemia-associated clinical signs in anemia, inject 100 mg (1 mL) by dogs with diabetes mellitus. intramuscular injection at 2 to 4 days (iii) Limitations. Federal law restricts of age. this drug to use by or on the order of a (ii) For treatment of iron deficiency licensed veterinarian. anemia, inject 100 mg (1 mL) by (2) Cats—(i) Amount—(A) Porcine insu- intramuscular injection. Dosage may lin zinc. Administer an initial dose of 1 be repeated in approximately 10 days. to 2 IU by subcutaneous injection. In- (2) No. 054771 for use of product de- jections should be given twice daily at scribed in paragraph (a)(1)(i) of this approximately 12-hour intervals. For section as follows: cats fed twice daily, the injections (i) For the prevention of anemia due should be concurrent with or right to iron deficiency, administer an ini- after a meal. For cats fed ad libitum, tial intramuscular injection of 100 mg no change in feeding is needed. Adjust at 2 to 4 days of age. Dosage may be re- the dose at appropriate intervals based peated in 14 to 21 days. on clinical signs, urinalysis results, (ii) For the treatment of anemia due and glucose curve values until ade- to iron deficiency, administer an quate glycemic control has been at- intramuscular injection of 200 mg. tained. (3) Nos. 000061 and 013744 for use of (B) Protamine zinc recombinant human product described in paragraph (a)(1)(i) insulin. Administer an initial dose of of this section as follows: 0.1 to 0.3 IU/pound of body weight (0.2 (i) For the prevention of iron defi- to 0.7 IU/kilogram) every 12 hours. The ciency anemia, administer dose should be given concurrently with intramuscularly an amount of drug or right after a meal. Re-evaluate the containing 100 to 150 mg of elemental cat at appropriate intervals and adjust iron to animals from 1 to 3 days of age. the dose based on both clinical signs (ii) For the treatment of iron defi- and glucose nadirs until adequate gly- ciency anemia, administer cemic control has been attained. intramuscularly an amount of drug (ii) Indications for use. For the reduc- containing 100 to 200 mg of elemental tion of hyperglycemia and hyper- iron per animal. Dosage may be re- glycemia-associated clinical signs in peated in 10 days to 2 weeks. cats with diabetes mellitus. (4) Nos. 051311 and 054771 for use of (iii) Limitations. Federal law restricts product described in paragraph this drug to use by or on the order of a (a)(1)(ii) of this section as follows: licensed veterinarian. (i) For prevention of iron deficiency anemia, administer 1 mL by [69 FR 25827, May 10, 2004, as amended at 73 intramuscular injection at 2 to 5 days FR 21042, Apr. 18, 2008; 74 FR 61517, Nov. 25, of age. Dosage may be repeated at 2 2009; 74 FR 66048, Dec. 14, 2009] weeks of age. § 522.1182 Iron injection. (ii) For treatment of iron deficiency anemia, administer 1 to 2 mL by (a) Specifications. See § 510.440 of this intramuscular injection at 5 to 28 days chapter. Each milliliter (mL) of solu- of age. tion contains the equivalent of: (5) No. 054771 for use of product de- (1) 100 milligrams (mg) of elemental scribed in paragraph (a)(1)(iii) of this iron derived from: section as follows: (i) Ferric hydroxide; (i) For prevention of anemia due to (ii) Ferric oxide; or iron deficiency, administer 100 mg by (iii) Elemental iron. intramuscular or subcutaneous injec- (2) 200 mg of elemental iron derived tion at 2 to 4 days of age. from ferric hydroxide. (ii) For treatment of anemia due to (b) Sponsors and conditions of use. It is iron deficiency, administer 100 mg by used in young piglets by sponsors in intramuscular or subcutaneous injec- § 510.600(c) of this chapter as follows: tion up to 4 weeks of age.

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(6) Nos. 016592 and 058005 for use of into a joint cavity, tendon sheath, or product described in paragraph bursa for local effect. (a)(1)(iii) of this section as follows: (B) Swine. The usual dose for a 300- (i) For prevention of anemia due to pound animal is 5 mg by intramuscular iron deficiency, administer 100 mg by injection. intramuscular injection at 2 to 4 days (ii) Indications for use. For alleviation of age. of pain associated with generalized and (ii) For treatment of anemia due to acute localized arthritic conditions; for iron deficiency, administer 100 mg by treating acute hypersensitivity reac- intramuscular injection. Treatment tions; and as an aid in correcting cir- may be repeated in 10 days. culatory defects associated with severe (7) Nos. 016592 and 042552 for use of toxicity and shock. product described in paragraph (a)(2) of (iii) Limitations. Animals intended for this section as follows: human consumption should not be slaughtered within 7 days of last treat- (i) For prevention of anemia due to ment. Federal law restricts this drug iron deficiency, intramuscularly inject to use by or on the order of a licensed 200 mg of elemental iron (1 mL) at 1 to veterinarian. 3 days of age. (ii) For treatment of anemia due to [79 FR 16190, Mar. 25, 2014] iron deficiency, intramuscularly inject 200 mg of elemental iron at the first § 522.1192 Ivermectin. sign of anemia. (a) Specifications—(1) Each milliliter (mL) of solution contains 20 milligrams [73 FR 12635, Mar. 10, 2008, as amended at 73 (mg) ivermectin. FR 14385, Mar. 18, 2008; 78 FR 17597, Mar. 22, (2) Each mL of solution contains 10 2013; 78 FR 44433, July 24, 2013; 79 FR 16190, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; 81 FR mg ivermectin. 59134, Aug. 29, 2016; 82 FR 11508, Feb. 24, 2017] (3) Each mL of solution contains 2.7 mg ivermectin. § 522.1185 Isoflupredone. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in (a) Specifications. Each milliliter of paragraph (e) of this section. suspension contains 2 milligrams (mg) (1) No. 050604 for use of the product of isoflupredone acetate. described in paragraph (a)(1) of this (b) Sponsor. See No. 054771 in section as in paragraph (e)(1) of this § 510.600(c) of this chapter. section; the product described in para- (c) Conditions of use—(1) Cattle—(i) graph (a)(2) of this section as in para- Amount. Administer 10 to 20 mg by graphs (e)(2), (e)(3), (e)(4), and (e)(5) of intramuscular injection. this section; and the product described (ii) Indications for use. For use in the in paragraph (a)(3) of this section as in treatment of bovine ketosis. For allevi- paragraphs (e)(3) and (e)(6) of this sec- ation of pain associated with general- tion. ized and acute localized arthritic con- (2) Nos. 016592, 055529, 058005, and ditions; for treating acute hyper- 061623 for use of the product described sensitivity reactions; and as an aid in in paragraph (a)(2) of this section as in correcting circulatory defects associ- paragraphs (e)(2), (e)(3), (e)(4), and (e)(5) ated with severe toxicity and shock. of this section. (iii) Limitations. Animals intended for (d) Special considerations—(1) See human consumption should not be § 500.25 of this chapter. slaughtered within 7 days of last treat- (2) Labeling shall bear the following ment. A withdrawal period has not precaution: ‘‘This product should not been established for this product in be used in other animal species as se- preruminating calves. Do not use in vere adverse reactions, including fa- calves to be processed for veal. Federal talities in dogs, may result.’’ law restricts this drug to use by or on (e) Conditions of use—(1) Horses—(i) the order of a licensed veterinarian. Amount. 200 micrograms per kilogram (2) Horses and swine—(i) Amount—(A) (μg/kg) of body weight by Horses. Administer 5 to 20 mg by intramuscular injection. intramuscular injection for systemic (ii) Indications for use. For the treat- effect or by intrasynovial injection ment and control of large strongyles

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(adult) (Strongylus vulgaris, S. edentatus, larvae) (large roundworm, Ascaris suum; Triodontophorus spp.), small strongyles red stomach worm, Hyostrongylus (adult and fourth stage larvae) rubidus; nodular worm, (Cyathostomum spp., Cylicocyclus spp., Oesophagostomum spp.; threadworm, Cylicostephanus spp.), pinworms (adult Strongyloides ransomi (adults only)); so- and fourth-stage larvae) (Oxyuris equi), matic roundworm larvae (threadworm, large roundworms (adult) (Parascaris S. ransomi (somatic larvae)); lungworms equorum), hairworms (adult) (Metastrongylus spp. (adults only)); lice (Trichostrongylus axei), large mouth (H. suis); and mites (S. scabiei var. suis). stomach worms (adult) (Habronema (iii) Limitations. Do not treat swine muscae), neck threadworms within 18 days of slaughter. (microfilariae) (Onchocerca spp.), and (4) American bison—(i) Amount. 200 μg/ stomach bots (Gastrophilus spp.). kg of body weight by subcutaneous in- (iii) Limitations. Not for use in horses jection. intended for human consumption. Fed- (ii) Indications for use. For the treat- eral law restricts this drug to use by or ment and control of grubs (H. bovis). on the order of a licensed veterinarian. (iii) Limitations. Do not slaughter (2) Cattle—(i) Amount. 200 μg/kg of within 56 days of last treatment. body weight by subcutaneous injection. (5) Reindeer—(i) Amount. 200 μg/kg of (ii) Indications for use. For the treat- body weight by subcutaneous injection. ment and control of gastrointestinal (ii) Indications for use. For the treat- nematodes (adults and fourth-stage lar- ment and control of warbles vae) (Haemonchus placei, Ostertagia (Oedemagena tarandi). ostertagi (including inhibited larvae), O. (iii) Limitations. Do not treat reindeer lyrata, Trichostrongylus axei, T. within 56 days of slaughter. colubriformis, Cooperia oncophora, C. (6) Ranch-raised foxes—(i) Amount. 200 punctata, C. pectinata, Oesophagostomum μg/kg of body weight by subcutaneous radiatum, Nematodirus helvetianus injection. Repeat in 3 weeks. (adults only), N. spathiger (adults only), (ii) Indications for use. For treatment Bunostomum phlebotomum); lungworms and control of ear mites (Otodectes (adults and fourth-stage larvae) cynotis). (Dictyocaulus viviparus); grubs (para- [72 FR 27735, May 17, 2007, as amended at 72 sitic stages) (Hypoderma bovis, H. FR 62771, Nov. 7, 2007; 74 FR 9049, Mar. 2, 2009; lineatum); sucking lice (Linognathus 75 FR 26647, May 12, 2010; 76 FR 57906, Sept. vituli, Haematopinus eurysternus, 19, 2011; 78 FR 17597, Mar. 22, 2013; 81 FR 59134, Solenopotes capillatus); mites (scabies) Aug. 29, 2016] (Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. bovis). For § 522.1193 Ivermectin and clorsulon. control of infections and to protect (a) Specifications. Each milliliter from reinfection with D. viviparus and (mL) of solution contains 10 milligrams O. radiatum for 28 days after treatment; (mg) (1 percent) ivermectin and 100 mg O. ostertagi, T. axei, and C. punctata for (10 percent) clorsulon. 21 days after treatment; H. placei and (b) Sponsors. See Nos. 050604, 055529, C. oncophora for 14 days after treat- and 058005 in § 510.600(c) of this chapter. ment. (c) Related tolerances. See §§ 556.163 (iii) Limitations. Do not treat cattle and 556.344 of this chapter. within 35 days of slaughter. Because a (d) Special considerations. See § 500.25 withdrawal time in milk has not been of this chapter. established, do not use in female dairy (e) Conditions of use in cattle—(1) cattle of breeding age. A withdrawal Amount. Administer 1 mL (10 mg period has not been established for this ivermectin and 100 mg clorsulon) per 50 product in pre-ruminating calves. Do kilograms (110 pounds) by subcuta- not use in calves to be processed for neous injection. veal. (2) Indications for use. For the treat- (3) Swine—(i) Amount. 300 μg/kg of ment and control of gastrointestinal body weight by subcutaneous injection. nematodes (adults and fourth-stage lar- (ii) Indications for use. For the treat- vae) (Haemonchus placei, Ostertagia ment and control of gastrointestinal ostertagi (including inhibited larvae), O. roundworms (adults and fourth-stage lyrata, Trichostrongylus axei, T.

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colubriformis, Cooperia oncophora, C. (3) Limitations. Federal law restricts punctata, C. pectinata, Oesophagostomum this drug to use by or on the order of a radiatum, Nematodirus helvetianus licensed veterinarian. (adults only), N. spathiger (adults only), [79 FR 16190, Mar. 25, 2014] Bunostomum phlebotomum; lungworms (adults and fourth-stage larvae) § 522.1222 Ketamine. (Dictyocaulus viviparus); liver flukes (adults only) (Fasciola hepatica); grubs (a) Specifications. Each milliliter con- (parasitic stages) (Hypoderma bovis, H. tains ketamine hydrochloride equivalent to 100 milligrams (mg) ketamine lineatum); lice (Linognathus vituli, base activity. Haematopinus eurysternus, Solenopotes capillatus); mites (Psoroptes ovis (syn. P. (b) Sponsors. See Nos. 000859, 026637, communis var. bovis), Sarcoptes scabiei 054628, 054771, 059399, and 063286 in var. bovis); and for control of infections § 510.600(c) of this chapter. of D. viviparus and O. radiatum for 28 (c) Special considerations. Federal law days afer treatment; O. ostertagi, T. restricts this drug to use by or on the axei, and C. punctata for 21 days after order of a licensed veterinarian. treatment; and H. placei and C. (d) Conditions of use—(1) Cats—(i) oncophora for 14 days after treatment. Amount. 5 to 15 mg/pound body weight (3) Limitations. For No. 050604: Do not intramuscularly, depending on the ef- treat cattle within 21 days of slaugh- fect desired. ter. For Nos. 055529 and 058005: Do not (ii) Indications for use. For restraint treat cattle within 49 days of slaugh- or as the sole anesthetic agent in diag- ter. Because a withdrawal time in milk nostic or minor, brief surgical proce- has not been established, do not use in dures that do not require skeletal muscle relaxation. female dairy cattle of breeding age. A withdrawal period has not been estab- (2) Subhuman primates—(i) Amount. 3 lished for preruminating calves. Do not to 15 mg/kilogram body weight intramuscularly, depending upon the use in calves to be processed for veal. species, general condition, and age of [55 FR 38984, Sept. 24, 1990, as amended at 62 the subject. FR 14302, Mar. 26, 1997; 62 FR 63271, Nov. 28, (ii) Indications for use. For restraint. 1997; 64 FR 26671, May 17, 1999; 69 FR 31735, June 7, 2004; 72 FR 27734, May 17, 2007; 77 FR [67 FR 17283, Apr. 10, 2002, as amended at 73 64717, Oct. 23, 2012; 79 FR 64116, Oct. 28, 2014] FR 8192, Feb. 13, 2008. Redesignated at 79 FR 16191, Mar. 25, 2014, as amended at 80 FR EDITORIAL NOTE: At 81 FR 22524, Apr. 18, 13229, Mar. 13, 2015] 2016, § 522.1193 was amended; however, the amendment could not be incorporated due to § 522.1223 Ketamine, promazine, and inaccurate amendatory instruction. aminopentamide. § 522.1204 Kanamycin. (a) Specifications. Each milliliter of solution contains ketamine hydro- (a) Specifications. Each milliliter of chloride equivalent to 100 milligrams solution contains 50 or 200 milligrams (mg) ketamine base activity, 7.5 (mg) (mg) of kanamycin as kanamycin sul- of promazine hydrochloride, and 0.0625 fate. mg of aminopentamide hydrogen sul- (b) Sponsor. See No. 054771 in fate. § 510.600(c) of this chapter. (b) Sponsor. See No. 054771 in (c) Conditions of use in dogs and cats— § 510.600(c) of this chapter. (1) Amount. Administer by subcuta- (c) Conditions of use in cats—(1) neous or intramuscular injection 5 mg Amount. Administer by intramuscular per pound of body weight per day in injection 15 to 20 mg ketamine base per equally divided doses at 12-hour inter- pound of body weight, depending on the vals. effect desired. (2) Indications for use. For the treat- (2) Indications for use. It is used in ment of bacterial infections due to cats as the sole anesthetic agent for kanamycin sensitive organisms in dogs ovariohysterectomy and general sur- and cats. gery.

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(3) Limitations. Federal law restricts (3) Limitations. Do not administer this drug to use by or on the order of a more than 10 milliliters per site. Cattle licensed veterinarian. that are severely parasitized or maintained under conditions of constant [79 FR 16191, Mar. 25, 2014] helminth exposure may require re- § 522.1225 Ketoprofen. treatment within 2 to 4 weeks after first treatment. Consult your veteri- (a) Specifications. Each milliliter of narian for assistance in the diagnosis, solution contains 100 milligrams (mg) treatment, and control of parasitism. of ketoprofen. Consult your veterinarian before using (b) Sponsor. See No. 054771 in in severely debilitated animals or ani- § 510.600(c) of this chapter. mals under severe stress. Do not ad- (c) Conditions of use in horses—(1) minister to cattle within 7 days of Amount. Administer by intravenous in- slaughter. Do not administer to dairy jection 1.0 mg per pound of body weight animals of breeding age. once daily for up to 5 days. (2) Indications for use. For alleviation [43 FR 20489, May 12, 1978, as amended at 43 of inflammation and pain associated FR 29289, July 7, 1978; 43 FR 60895, Dec. 29, with musculoskeletal disorders in 1978; 47 FR 10807, Mar. 12, 1982; 62 FR 61625, horses. Nov. 19, 1997; 65 FR 61090, Oct. 16, 2000; 67 FR (3) Limitations. Do not use in horses 63055, Oct. 10, 2002. Redesignated and amended at 79 FR 16191, Mar. 25, 2014] intended for human consumption. Fed- eral law restricts this drug to use by or § 522.1260 Lincomycin. on the order of a licensed veterinarian. (a) Specifications. Each milliliter of [79 FR 16191, Mar. 25, 2014] solution contains lincomycin hydrochloride monohydrate equivalent to: § 522.1242 Levamisole. (1) 25, 50, 100, or 300 milligrams (mg) (a) Specifications. Each milliliter of lincomycin. solution contains levamisole phosphate (2) 25, 100, or 300 mg lincomycin. equivalent to 136.5 or 182 milligrams of (3) 300 mg lincomycin. levamisole hydrochloride (13.65 or 18.2 (4) 100 or 300 mg lincomycin. percent). (b) Sponsors. See sponsors in (b) Sponsor. See Nos. 000061 and 057561 § 510.600(c) of this chapter for uses as in in § 510.600 of this chapter for use of paragraph (e) of this section. 13.65 percent injection, and see No. (1) No. 054771 for use of concentra- 054771 for use of 13.65 and 18.2 percent tions in paragraph (a)(1) of this section injection. as in paragraph (e) of this section. (c) Conditions of use—(1) Amount. 2 (2) Nos. 016592 and 058005 for use of milliliters per 100 pounds of body concentrations in paragraph (a)(2) of weight, subcutaneously in the neck. this section as in paragraph (e)(2) of (2) Indications for use. (i) The 13.65 this section. percent injection is used as an anthel- (3) No. 054771 for use of concentration mintic in cattle for treatment of the in paragraph (a)(3) of this section as in following parasites: stomach worms paragraph (e)(2) of this section. (Haemonchus, Trichostrongylus, (4) No. 061623 for use of concentra- Ostertagia), intestinal worms tions in paragraph (a)(4) of this section (Trichostrongylus, Cooperia, as in paragraph (e)(2) of this section. Nematodirus, Bunostomum, (c) Special considerations. When com- Oesophagostomum, Chabertia), and mon labeling for use of the drug in lungworms (Dictyocaulus). dogs, cats, and swine is included with (ii) The 18.2 percent injection is used the drug, all such uses are subject to as an anthelmintic in cattle for treat- the labeling requirements of § 201.105 of ment of the following parasites: stom- this chapter. ach worms (Haemonchus, (d) Related tolerances. See § 556.360 of Trichostrongylus, Ostertagia), intestinal this chapter. worms (Trichostrongylus, Cooperia, (e) Conditions of use. It is used for ani- Nematodirus, Bunostomum, mals as follows: Oesophagostomum) and lungworms (1) Dogs and cats—(i) Amount. 5 mg (Dictyocaulus). per pound (/lb) of body weight twice

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daily or 10 mg/lb body weight once women may be unaware of their preg- daily by intramuscular injection; 5 to nancies. Luprostiol is readily absorbed 10 mg/lb body weight one or two times through the skin and can cause abor- daily by slow intravenous injection. tion and/or bronchiospasms. Direct (ii) Indications for use. Infections contact with the skin should therefore caused by Gram-positive organisms, be avoided. Accidental spillage on the particularly streptococci and skin should be washed off immediately staphylococci. with soap and water. (iii) Limitations. Federal law restricts (d) Conditions of use in horses—(1) this drug to use by or on the order of a Amount. 7.5 mg by intramuscular injec- licensed veterinarian. tion. (2) Swine—(i) Amount. 5 mg/lb body (2) Indications for use. For estrus weight once daily by intramuscular in- control and termination of pregnancy jection for 3 to 7 days. in mares. (ii) Indications for use. Treatment of (3) Limitations. Federal law restricts infectious arthritis and mycoplasma this drug to use by or on the order of a pneumonia. licensed veterinarian. Do not use in (iii) Limitations. Do not treat within horses intended for human consump- 48 hours of slaughter. tion. [40 FR 13858, Mar. 27, 1975, as amended at 50 [55 FR 1185, Jan. 12, 1990, as amended at 56 FR 31351, Aug. 2, 1985; 67 FR 34388, May 14, FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 2002; 68 FR 51705, Aug. 28, 2003; 69 FR 11507, 1995; 61 FR 66582, Dec. 18, 1996; 74 FR 25146, Mar. 11, 2004; 69 FR 47361, Aug. 5, 2004; 71 FR May 27, 2009] 51996, Sept. 1, 2006; 78 FR 17597, Mar. 22, 2013; 79 FR 16191, Mar. 25, 2014; 81 FR 59134, Aug. § 522.1315 Maropitant. 29, 2016] (a) Specifications. Each milliliter of § 522.1289 Lufenuron. solution contains 10 milligrams (mg) (a) Specifications. Each milliliter of maropitant as maropitant citrate. suspension contains 100 milligrams (b) Sponsor. See No. 054771 in (mg) of lufenuron. § 510.600(c) of this chapter. (b) Sponsor. See No. 058198 in (c) Conditions of use—(1) Dogs—(i) § 510.600(c) of this chapter. Amount. Administer 1.0 mg per kilo- (c) Conditions of use in cats—(1) gram (mg/kg) of body weight by sub- Amount. 10 mg per kilogram (4.5 mg per cutaneous or intravenous injection pound) of body weight every 6 months, once daily for up to 5 consecutive days. by subcutaneous injection. (ii) Indications for use. For the pre- (2) Indications for use. For control of vention and treatment of acute vom- flea populations in cats 6 weeks of age iting. and older. (iii) Limitations. Federal law restricts (3) Limitations. Federal law restricts this drug to use by or on the order of a this drug to use by or on the order of a licensed veterinarian. licensed veterinarian. (2) Cats—(i) Amount. Administer 1.0 mg/kg of body weight by subcutaneous [79 FR 16191, Mar. 25, 2014, as amended at 80 FR 61297, Oct. 13, 2015] or intravenous injection once daily for up to 5 consecutive days. § 522.1290 Luprostiol. (ii) Indications for use. For the treatment of vomiting. (a) Specifications. Each milliliter of solution contains 7.5 milligrams (mg) (iii) Limitations. Federal law restricts luprostiol. this drug to use by or on the order of a (b) Sponsor. See No. 051311 in licensed veterinarian. § 510.600(c) of this chapter. [72 FR 9243, Mar. 1, 2007, as amended at 77 FR (c) Special considerations. Labeling 39391, July 3, 2012; 79 FR 16191, Mar. 25, 2014; shall bear the following statements: 81 FR 22524, Apr. 18, 2016] Warning: Women of childbearing age, asthmatics, and persons with bronchial § 522.1335 Medetomidine. and other respiratory problems should (a) Specifications. Each milliliter of exercise extreme caution when han- solution contains 1.0 milligrams of dling this product. In the early stages, medetomidine hydrochloride.

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(b) Sponsor. See Nos. 015914 and 052483 and severe, respectively) caused by im- in § 510.600(c) of this chapter. mature (4 month-old, stage L5) to ma- (c) Conditions of use—(1) Amount. 750 ture adult infections of Dirofilaria micrograms intravenously (IV) or 1,000 immitis in dogs. micrograms intramuscularly per (3) Limitations. Federal law restricts square meter of body surface. The IV this drug to use by or on the order of a route is more efficacious for dental licensed veterinarian. care. [60 FR 49340, Sept. 25, 1995, as amended at 79 (2) Indications for use. As a sedative FR 16191, Mar. 25, 2014; 82 FR 21690, May 10, and analgesic in dogs over 12 weeks of 2017] age to facilitate clinical examinations, clinical procedures, minor surgical pro- § 522.1367 Meloxicam. cedures not requiring muscle relax- (a) Specifications. Each milliliter of ation, and minor dental procedures not solution contains 5.0 milligrams (mg) requiring intubation. The intravenous meloxicam. route of administration is more effica- (b) Sponsors. See Nos. 000010, 016729, cious for dental care. 026637, and 055529 in § 510.600(c) of this (3) Limitations. Federal law restricts chapter. this drug to use by or on the order of a (c) Conditions of use—(1) Dogs—(i) licensed veterinarian. Amount. Administer 0.09 mg per pound [61 FR 21075, May 9, 1996, as amended at 79 (mg/lb) body weight (0.2 mg per kilo- FR 16191, Mar. 25, 2014; 82 FR 58556, Dec. 13, gram (mg/kg)) by intravenous or sub- 2017] cutaneous injection on the first day of treatment. For treatment after day 1, § 522.1350 Melatonin implant. administer meloxicam suspension oral- (a) Specifications. The drug is a sili- ly at 0.045 mg/lb (0.1 mg/kg) body cone rubber elastomer implant con- weight once daily as in § 520.1350(c) of taining 2.7 milligrams of melatonin. this chapter. (b) Sponsor. See No. 053923 in (ii) Indications for use. For the control § 510.600(c) of this chapter. of pain and inflammation associated (c) Conditions of use—(1) Amount. One with osteoarthritis. implant per mink. (iii) Limitations. Federal law restricts (2) Indications for use. For use in this drug to use by or on the order of a healthy male and female kit and adult licensed veterinarian. female mink (Mustela vison) to accel- (2) Cats—(i) Amount. Administer 0.14 erate the fur priming cycle. mg/lb (0.3 mg/kg) body weight as a sin- (3) Limitations. For subcutaneous im- gle, one-time subcutaneous injection. plantation in mink only. Do not im- (ii) Indications for use. For the control plant potential breeding stock. Do not of postoperative pain and inflamma- use in food-producing animals. tion associated with orthopedic surgery, ovariohysterectomy, and castra- [59 FR 37422, July 22, 1994] tion when administered prior to sur- § 522.1362 Melarsomine powder for in- gery. jection. (iii) Limitations. Federal law restricts (a) Specifications. The drug consists of this drug to use by or on the order of a a vial of lyophilized powder containing licensed veterinarian. 50 milligrams of melarsomine [68 FR 68724, Dec. 10, 2003, as amended at 69 dihydrochloride which is reconstituted FR 69523, Nov. 30, 2004; 78 FR 5715, Jan. 28, with the provided 2 milliliters of ster- 2013; 79 FR 74020, Dec. 15, 2014] ile water for injection. (b) Sponsor. See Nos. 050604 and 086073 § 522.1372 Mepivacaine. in § 510.600(c) of this chapter. (a) Specifications. Each milliliter (c) Conditions of use—(1) Amount. Ad- (mL) of solution contains 20 milligrams minister only by deep intramuscular mepivacaine hydrochloride. injection in the lumbar muscles (L3– (b) Sponsor. See No. 054771 in L5). § 510.600(c) of this chapter. (2) Indications. Treatment of sta- (c) Conditions of use in horses—(1) bilized, class 1, 2, and 3 heartworm dis- Amount. For nerve block, 3 to 5 mL; for ease (asymptomatic to mild, moderate, epidural anesthesia, 5 to 20 mL; for

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intra-articular anesthesia, 10 to 15 mL; (b) Sponsors. See Nos. 054628 and for infiltration, as required; for anes- 054771 in § 510.600(c) of this chapter. thesia of the laryngeal mucosa prior to (c) [Reserved] ventriculectomy, by topical spray, 25 (d) Conditions of use—(1) Dogs—(i) to 40 mL, by infiltration, 20 to 50 mL. Amount. Administer 2 to 40 mg (up to (2) Indications for use. For use as a 120 mg in extremely large breeds or local anesthetic for infiltration, nerve dogs with severe involvement) by block, intra-articular and epidural an- intramuscular injection or up to 20 mg esthesia, and topical and/or infiltration by intrasynovial injection. anesthesia of the laryngeal mucosa (ii) Indications for use. For treatment prior to ventriculectomy. of inflammation and related disorders; (3) Limitations. Not for use in horses treatment of allergic and dermatologic intended for human consumption. Fed- disorders; and as supportive therapy to eral law restricts this drug to use by or antibacterial treatment of severe infec- on the order of a licensed veterinarian. tions. (iii) Limitations. Federal law restricts [71 FR 39547, July 13, 2006, as amended at 79 this drug to use by or on the order of a FR 16191, Mar. 25, 2014] licensed veterinarian. (2) Cats—(i) Amount. Administer 10 to § 522.1380 Methocarbamol. 20 mg by intramuscular injection. (a) Specifications. Each milliliter of (ii) Indications for use. For treatment solution contains 100 milligrams (mg) of inflammation and related disorders; of methocarbamol. treatment of allergic and dermatologic (b) Sponsor. See No. 051031 in disorders; and as supportive therapy to § 510.600(c) of this chapter. antibacterial treatment of severe infec- (c) Conditions of use—(1) Amount—(i) tions. Dogs and cats. Administer by intra- (iii) Limitations. Federal law restricts venous injection 20 mg per pound of this drug to use by or on the order of a body weight for moderate conditions or licensed veterinarian. 25 to 100 mg per pound of body weight (3) Horses—(i) Amount. Administer 200 for severe conditions (tetanus and mg by intramuscular injection or 40 to strychnine poisoning). The total cumu- 240 mg by intrasynovial injection. lative dose should not to exceed 150 mg (ii) Indications for use. For treatment per pound of body weight. of inflammation and related disorders. (ii) Horses. Administer by intra- (iii) Limitations. Do not use in horses venous injection 2 to 10 mg per pound intended for human consumption. Fed- of body weight for moderate conditions eral law restricts this drug to use by or or 10 to 25 mg per pound of body weight on the order of a licensed veterinarian. for severe conditions (tetanus). Addi- [43 FR 59058, Dec. 19, 1978, as amended at 51 tional amounts may be needed to re- FR 741, Jan. 8, 1986; 53 FR 40728, Oct. 18, 1988; lieve residual effects and to prevent re- 62 FR 35076, June 30, 1997; 76 FR 53051, Aug. currence of symptoms. 25, 2011; 78 FR 21060, Apr. 9, 2013; 79 FR 16191, (2) Indications for use. As an adjunct Mar. 25, 2014] for treating acute inflammatory and § 522.1450 Moxidectin solution. traumatic conditions of the skeletal muscles and to reduce muscular (a) Specifications. Each milliliter of spasms. solution contains 10 milligrams (mg) (3) Limitations. Do not use in horses moxidectin. intended for human consumption. Fed- (b) Sponsor. See No. 000859 in eral law restricts this drug to use by or § 510.600(c) of this chapter. on the order of a licensed veterinarian. (c) Related tolerances. See § 556.426 of this chapter. [79 FR 16191, Mar. 25, 2014, as amended at 82 (d) Special considerations. See § 500.25 FR 11508, Feb. 24, 2017] of this chapter. (e) Conditions of use in beef and non- § 522.1410 Methylprednisolone. lactating dairy cattle—(1) Amount. Ad- (a) Specifications. Each milliliter of minister 0.2 mg/kg of body weight (0.2 suspension contains 20 or 40 milligrams mg/2.2 pound) as a single, subcutaneous (mg) of methylprednisolone acetate. injection.

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(2) Indications for use. For treatment (0.0773 mg per pound) as a single sub- and control of gastrointestinal cutaneous injection. roundworms: Ostertagia ostertagi (2) Indications for use. For prevention (adults, fourth-stage larvae, and inhib- of heartworm disease caused by ited larvae), Haemonchus placei Dirofilaria immitis; for treatment of ex- (adults), Trichostrongylus axei (adults isting larval and adult hookworm and fourth-stage larvae), (Ancylostoma caninum) and Uncinaria Trichostrongylus colubriformis (adults stenocephala infections. and fourth-stage larvae), Cooperia (3) Limitations. Federal law restricts oncophora (adults), Cooperia pectinata this drug to use by or on the order of a (adults), Cooperia punctata (adults and licensed veterinarian. fourth-stage larvae), Cooperia spatulata [66 FR 35756, July 9, 2001, as amended at 67 (adults), Cooperia surnabada (adults and FR 57944, Sept. 13, 2002; 79 FR 16191, Mar. 25, fourth-stage larvae), Nematodirus 2014] helvetianus (adults), Oesophagostomum radiatum (adults and fourth-stage lar- § 522.1452 Nalorphine. vae), Trichuris spp. (adults); (a) Specifications. Each milliliter of lungworms: Dictyocaulus viviparus solution contains 5 milligrams of (adults and fourth-stage larvae); grubs: nalorphine hydrochloride. Hypoderma bovis and Hypoderma (b) Sponsor. See No. 050604 in lineatum; mites: Psoroptes ovis § 510.600(c) of this chapter. (Psoroptes communis var. bovis); lice: (c) Conditions of use in dogs—(1) Linognathus vituli and Solenopotes Amount. One milligram per 5 pounds; capillatus; for protection of cattle from intravenously, intramuscularly, or reinfection with D. viviparus and O. subcutaneously. radiatum for 42 days after treatment, (2) Indications for use. Respiratory with H. placei for 35 days after treat- and circulatory depression in dogs re- ment, and with O. ostertagi and T. axei sulting from overdosage of, or unusual for 14 days after treatment. sensitivity to, morphine and certain (3) Limitations. Do not slaughter cat- other narcotics. Not for depression due tle within 21 days of treatment. Be- to any other cause. cause a withholding time for milk has (3) Limitations. Federal law restricts not been established, do not use in fe- this drug to use by or on the order of a male dairy cattle 20 months of age and licensed veterinarian. older. A withdrawal period has not been established for pre-ruminating [44 FR 6707, Feb. 2, 1979, as amended at 47 FR calves. Do not use in calves to be proc- 36418, Aug. 20, 1982; 62 FR 63271, Nov. 28, 1997; essed for veal. 79 FR 16191, Mar. 25, 2014] [70 FR 36337, June 23, 2005, as amended at 71 § 522.1465 Naltrexone. FR 7414, Feb. 13, 2006; 76 FR 48714, Aug. 9, (a) Specifications. Each milliliter of 2011; 82 FR 21690, May 10, 2017] solution contains 50 milligrams of naltrexone hydrochloride. § 522.1451 Moxidectin microspheres for injection. (b) Sponsor. See 053923 in § 510.600(c) of this chapter. (a) Specifications. The drug product (c) Conditions of use in elk and moose— consists of two separate vials. One con- (1) Amount. 100 milligrams of tains 10 percent moxidectin micro- naltrexone hydrochloride for each mil- spheres, and the other contains a vehi- ligram of carfentanil citrate adminis- cle for constitution of the moxidectin tered. One-quarter of the dose should microspheres. Each milliliter of con- be administered intravenously and stituted, sustained-release suspension three-quarters of the dose should be ad- contains 3.4 milligrams (mg) of ministered subcutaneously. moxidectin. (2) Indications for use. As an antago- (b) Sponsor. See No. 054771 in nist to carfentanil citrate immobiliza- § 510.600(c) of this chapter. tion in free-ranging or confined elk and (c) [Reserved] moose (Cervidae). (d) Conditions of use; dogs—(1) Amount. (3) Limitations. Do not use in domes- 0.17 mg per kilogram body weight tic food-producing animals. Do not use

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in free-ranging animals for 45 days be- by or on the order of a licensed veteri- fore or during hunting season. Federal narian. law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 16192, Mar. 25, 2014] [62 FR 5320, Feb. 5, 1997, as amended at 79 FR § 522.1503 Neostigmine. 16191, Mar. 25, 2014] (a) Specifications. Each milliliter of solution contains 2 milligrams (mg) ne- § 522.1468 Naproxen for injection. ostigmine methylsulfate. (a) Specifications. The drug is a (b) Sponsor. See No. 000061 in lyophilized powder which is reconsti- § 510.600(c) of this chapter. tuted with sterile water for injection (c) Conditions of use—(1) Amount. Ad- to form a 10 percent sterile aqueous so- minister to cattle and horses at a dos- lution (100 milligrams per milliliter). age level of 1 mg per (/) 100 pounds (lbs) (b) Sponsor. See 054771 in § 510.600(c) of of body weight subcutaneously. Admin- this chapter. ister to sheep at a dosage level of 1 to (c) Conditions of use in horses—(1) Dos- 11⁄2 mg/100 lbs body weight age. Five milligrams per kilogram of subcutaneously. Administer to swine body weight intravenously followed by at a dosage level of 2 to 3 mg/100 lbs maintenance oral therapy of 10 milli- body weight intramuscularly. These grams per kilogram of body weight doses may be repeated as indicated. twice daily for up to 14 consecutive (2) For treating days. Indications for use. rumen atony; initiating peristalsis (2) Indications for use. For the relief of which causes evacuation of the bowel; inflammation and associated pain and emptying the urinary bladder; and lameness exhibited with arthritis, as stimulating skeletal muscle contrac- well as myositis and other soft tissue diseases of the musculoskeletal system tions. of the horse. (3) Limitations. Not for use in animals (3) Limitations. Not for use in horses producing milk, since this use will re- intended for food. Federal law restricts sult in contamination of the milk. Fed- this drug to use by or on the order of a eral law restricts this drug to use by or licensed veterinarian. on the order of a licensed veterinarian. [46 FR 26763, May 15, 1981. Redesignated and [40 FR 13858, Mar. 27, 1975, as amended at 62 amended at 51 FR 24525, July 7, 1986; 61 FR FR 61625, Nov. 19, 1997; 79 FR 16192, Mar. 25, 5507, Feb. 13, 1996; 79 FR 16192, Mar. 25, 2014] 2014]

§ 522.1484 Neomycin. § 522.1610 Oleate sodium. (a) Specifications. Each milliliter of (a) Specifications. Each milliliter of solution contains 50 milligrams (mg) of solution contains 50 milligrams (mg) of neomycin sulfate (equivalent to 35 mg sodium oleate. of neomycin base). (b) Sponsor. See No. 037990 in (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) (c) Conditions of use in dogs and cats— Amount. Administer by parenteral in- (1) Amount. Administer 5 mg per pound jection depending on the area of re- of body weight daily by intramuscular sponse desired. An injection of 1 milli- or intravenous injection, divided into liter (mL) will produce a response of portions administered every 6 to 8 approximately 15 square centimeters. hours for 3 to 5 days. Do not inject more than 2 mL per in- (2) Indications for use. For the treat- jection site. Regardless of the number ment of acute and chronic bacterial in- of injection sites, the total volume fections due to organisms susceptible used should not exceed 10 mL. to neomycin. (2) Indications for use. It is used in (3) Limitations. Not for parenteral use horses to stimulate infiltration of cel- in food-producing animals because of lular blood components that subse- prolonged residues in edible tissues. quently differentiate into fibrous and/ Federal law restricts this drug to use or fibrocartilagenous tissue.

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(3) Limitations. Do not use in horses § 522.1660 Oxytetracycline injectable intended for human consumption. Fed- dosage forms. eral law restricts this drug to use by or on the order of a licensed veterinarian. § 522.1660a Oxytetracycline solution, 200 milligrams/milliliter. [41 FR 27034, July 1, 1976, as amended at 50 (a) Specifications. Each milliliter of FR 40966, Oct. 8, 1985; 79 FR 16192, Mar. 25, sterile solution contains 200 milligrams 2014] of oxytetracycline base. § 522.1620 Orgotein for injection. (b) Sponsors. See Nos. 000010, 016592, 048164, 054771, 055529, 057561, and 061623 (a) Specifications. Orgotein for injec- in § 510.600(c) of this chapter. tion is packaged in a vial containing 5 (c) Related tolerances. See § 556.500 of milligrams of orgotein and 10 milli- this chapter. grams of sucrose as lyophilized sterile (d) Special considerations. When la- nonpyrogenic powder with directions beled for the treatment of for dissolving the contents of the vial anaplasmosis or anthrax, labeling shall in 2 milliliters of diluent which is so- also bear the following: ‘‘Federal law dium chloride injection, U.S.P. restricts this drug to use by or on the (b) Sponsor. See No. 024991 in order of a licensed veterinarian.’’ § 510.600(c) of this chapter. (e) Conditions of use—(1) Beef cattle, (c) Conditions of use—(1) Horses—(i) dairy cattle, and calves including Amount. Administer by deep prerumenative (veal) calves—(i) Amounts intramuscular injection at a dosage and indications for use—(A) 3 to 5 mg level of 5 milligrams (mg) every other per pound of body weight (mg/lb BW) day for 2 weeks and twice weekly for 2 per day (/day) intramuscularly, to 3 more weeks. Severe cases, both subcutaneously, or intravenously for treatment of pneumonia and shipping acute and chronic, may benefit more fever complex associated with from daily therapy initially. Dosage Pasteurella spp. and Haemophilus spp., may be continued beyond 5 weeks if foot-rot and diphtheria caused by satisfactory improvement has not been Fusobacterium necrophorum, bacterial achieved. enteritis (scours) caused by Escherichia (ii) Indications for use. It is used in coli, wooden tongue caused by the treatment of soft tissue inflamma- Actinobacillus lignieresii, leptospirosis tion associated with the musculo- caused by Leptospira pomona, wound in- skeletal system. fections and acute metritis caused by (iii) Limitations. Do not use in horses Staphylococcus spp. and Streptococcus intended for human consumption. Fed- spp., and anthrax caused by Bacillus eral law restricts this drug to use by or anthracis. on the order of a licensed veterinarian. (B) 5 mg/lb BW/day intramuscularly (2) Dogs—(i) Amount. Administer by or intravenously for treatment of subcutaneous injection 5 mg daily for 6 anaplasmosis caused by Anaplasma days, and thereafter, every other day marginale, severe foot-rot, and ad- for 8 days. In less severe conditions, vanced cases of other indicated dis- shorter courses of therapy may be indi- eases. cated. (C) 9 mg/lb BW intramuscularly or (ii) Indications for use. It is used for subcutaneously as single dosage where the relief of inflammation associated retreatment of calves and yearlings for with ankylosing spondylitis, bacterial pneumonia is impractical, for spondylosis, and disc disease. When se- treatment of infectious bovine vere nerve damage is present, response keratoconjunctivitis (pinkeye) caused by Moraxella bovis, or where retreat- will occur much more slowly, if at all. ment for anaplasmosis is impractical. (iii) Federal law restricts Limitations. (ii) Limitations. Exceeding the highest this drug to use by or on the order of a recommended level of drug per pound licensed veterinarian. of bodyweight per day, administering [40 FR 13858, Mar. 27, 1975, as amended at 41 more than the recommended number of FR 32583, Aug. 4, 1976; 79 FR 16192, Mar. 25, treatments, and/or exceeding 10 mL 2014] intramuscularly or subcutaneously per

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injection site in adult beef and dairy cluding preruminating (veal) calves—(i) cattle may result in antibiotic residues Amounts and indications for use—(A) 3 to beyond the withdrawal time. Rapid in- 5 mg per pound of bodyweight (mg/lb travenous administration in cattle BW) per day (/day) intramuscularly, may result in animal collapse. Oxytet- subcutaneously, or intravenously for racycline should be administered intra- treatment of pneumonia and shipping venously slowly over a period of at fever complex associated with least 5 minutes. Discontinue treatment Pasteurella spp. and Histophilus spp., at least 28 days prior to slaughter. foot-rot and diphtheria caused by Milk taken from animals during treat- Fusobacterium necrophorum, bacterial ment and for 96 hours after the last enteritis (scours) caused by Escherichia treatment must not be used for food. coli, wooden tongue caused by (2) Swine—(i) Amounts and indications Actinobacillus lignieresii, leptospirosis for use—(A) Sows: 3 mg/lb BW caused by Leptospira pomona, wound in- intramuscularly once, approximately 8 fections and acute metritis caused by hours before farrowing or immediately Staphylococcus spp. and Streptococcus after completion of farrowing, as an aid spp. in control of infectious enteritis (baby (B) 5 mg/lb BW/day intramuscularly, pig scours, colibacillosis) in suckling subcutaneously, or intravenously for pigs caused by E. coli. treatment of severe foot-rot, and ad- (B) 3 to 5 mg/lb BW/day vanced cases of other indicated dis- intramuscularly for treatment of bac- eases. terial enteritis (scours, colibacillosis) (C) 9 mg/lb BW intramuscularly or caused by E. coli, pneumonia caused by subcutaneously as single dosage where Pasteurella multocida, and leptospirosis retreatment of calves and yearlings for caused by Leptospira pomona. bacterial pneumonia is impractical or (C) 9 mg/lb BW as a single dosage for treatment of infectious bovine where retreatment for pneumonia is keratoconjunctivitis (pinkeye) caused impractical. by Moraxella bovis. (ii) Limitations. Administer (D) 9 to 13.6 mg/lb BW intramuscularly. Do not inject more intramuscularly or subcutaneously as than 5 mL per site in adult swine. Dis- single dosage where retreatment of continue treatment at least 28 days calves and yearlings for bacterial pneu- prior to slaughter. monia is impractical or for treatment [45 FR 16479, Mar. 14, 1980. Redesignated and of infectious bovine amended at 69 FR 31879, June 8, 2004] keratoconjunctivitis (pinkeye) caused by Moraxella bovis. EDITORIAL NOTE: For FEDERAL REGISTER ci- (E) 13.6 mg/lb BW intramuscularly or tations affecting § 522.1660a, see the List of CFR Sections Affected, which appears in the subcutaneously as a single dosage for Finding Aids section of the printed volume control of respiratory disease in cattle and at www.fdsys.gov. at high risk of developing BRD associated with Mannheimia (Pasteurella) § 522.1660b Oxytetracycline solution, haemolytica. 300 milligrams/milliliter. (ii) Limitations. Treatment should be (a) Specifications. Each milliliter continued 24 to 48 hours following re- (mL) of solution contains 300 milli- mission of disease signs, however, not grams (mg) oxytetracycline base. to exceed a total of four consecutive (b) Sponsor. See No. 055529 in days. Do not inject more than 10 mL § 510.600(c) of this chapter. per site in adult cattle, reducing the (c) Related tolerances. See § 556.500 of volume according to age and body size this chapter. to 1 to 2 mL in small calves. Exceeding (d) Special considerations. When la- the highest recommended level of drug/ beled for use as in paragraph (e)(1)(i)(D) lb BW/day, administering more than or (e)(1)(i)(E) of this section, labeling the recommended number of treat- shall also bear the following: ‘‘Federal ments, and/or exceeding 10 mL law restricts this drug to use by or on intramuscularly or subcutaneously per the order of a licensed veterinarian.’’. injection site may result in antibiotic (e) Conditions of use—(1) Beef cattle, residues beyond the withdrawal time. nonlactating dairy cattle, and calves in- Rapid intravenous administration may

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result in animal collapse. Oxytetra- pathogens listed as follows: pneumonia cycline should be administered intra- and shipping fever complex (Pasteurella venously slowly over a period of at spp.; Hemophilis spp.; Klebsiella spp. ), least 5 minutes. Discontinue treatment bacterial enteritis (scours) (E. coli), at least 28 days prior to slaughter. Not foot-rot (Spherophorus necrophorus), for use in lactating dairy animals. diphtheria (Spherophorus necrophorus), (2) Swine—(i) Amounts and indications wooden tongue (Actinobacillus for use—(A) Sows: 3 mg/lb BW lignieresi), leptospirosis (Leptospira po- intramuscularly once, approximately 8 mona), and wound infections; acute me- hours before farrowing or immediately tritis; traumatic injury (caused by a after completion of farrowing, as an aid variety of bacterial organisms (such as in control of infectious enteritis (baby streptococcal and staphylococcal orga- pig scours, colibacillosis) in suckling nisms).) pigs caused by E. coli. (ii) It is administered by (B) 3 to 5 mg/lb BW/day intramuscular injection of 3 to 5 milli- intramuscularly for treatment of bac- grams of oxytetracycline hydro- terial enteritis (scours, colibacillosis) chloride per pound of body weight per caused by E. coli, pneumonia caused by day. Leptospirosis, severe foot-rot and Pasteurella multocida, and leptospirosis severe forms of the indicated diseases caused by Leptospira pomona. should be treated with 5 milligrams per (C) 9 mg/lb BW as a single dosage pound of body weight per day. Treat- where retreatment for pneumonia is ment should be continued for 24 to 48 impractical. hours following remission of disease (ii) Limitations. Administer symptoms; however, not to exceed a intramuscularly. Treatment should be total of 4 consecutive days. Only 2 mil- continued 24 to 48 hours beyond remis- liliters of the drug should be injected sion of disease signs, however, not to per site in case of calves weighing 100 exceed a total of 4 consecutive days. pounds or less and not more than 10 Exceeding the highest recommended milliliters should be injected per site level of drug/lb BW/day, administering in adult cattle. more than the recommended number of (iii) Discontinue treatment with the treatments, and/or exceeding 5 mL drug at least 20 days prior to slaughter intramuscularly per injection site may of the animal. When administered to result in antibiotic residues beyond the animals within 30 days of slaughter, withdrawal time. Discontinue treat- muscle discoloration may necessitate ment at least 28 days prior to slaugh- trimming of injection site and sur- ter. rounding tissues. (iv) For use only in beef cattle, beef [68 FR 54805, Sept. 19, 2003. Redesignated and calves, nonlactating dairy cattle, and amended at 69 FR 31879, June 8, 2004; 73 FR 14926, Mar. 20, 2008] dairy calves. (b)(1) Specifications. Each milliliter of § 522.1662 Oxytetracycline hydro- sterile solution contains 50 or 100 milli- chloride implantation or injectable grams of oxytetracycline (as oxytetra- dosage forms. cycline hydrochloride). (2) Sponsor. See 054628 in § 510.600(c) of § 522.1662a Oxytetracycline hydro- this chapter. chloride injection. (3) Conditions of use—(i) Beef cattle (a)(1) Specifications. The drug con- and nonlactating dairy cattle—(a) tains 50 milligrams of oxytetracycline Amount. Three to 5 milligrams of oxy- hydrochloride in each milliliter of ster- tetracycline per pound of body weight ile solution. per day; 5 milligrams per pound of body (2) Sponsor. See No. 054628 in weight per day for the treatment of § 510.600(c) of this chapter. anaplasmosis, severe foot-rot, and se- (3) Conditions of use. (i) The drug is vere cases of other indicated diseases. intended for use in beef cattle, beef (b) Indications for use. Treatment of calves, nonlactating dairy cattle, and diseases due to oxytetracycline-suscep- dairy calves for treatment of disease tible organisms as follows: Pneumonia conditions caused by one or more of and shipping fever complex associated the following oxytetracycline sensitive with Pasteurella spp., Haemophilus spp.,

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and Klebsiella spp., foot-rot and diph- for more than 4 consecutive days. Dis- theria caused by Spherophorus continue treatment at least 26 days be- necrophorus, bacterial enteritis (scours) fore slaughter. caused by Escherichia coli, wooden (c)(1) Specifications. The drug con- tongue caused by Actinobacillus tains 50 or 100 milligrams of oxytetra- lignieresi, leptospirosis caused by cycline hydrochloride in each milliliter Leptospira pomona, and wound infec- of sterile solution. tions and acute metritis caused by (2) Sponsor. See No. 054771 in Staphylococcus spp. and Streptococcus § 510.600(c) of this chapter. spp. If labeled for use by or on the (3) Conditions of use. (i) The drug is order of a licensed veterinarian, it may intended for use in the treatment of be used for the treatment of disease due to oxytetracycline-suscep- anaplasmosis caused by Anaplasma tible organisms in beef cattle and non- marginale. lactating dairy cattle. It is indicated in (c) Limitations. For 50-milligram-per- the treatment of pneumonia and ship- milliliter solution, administer ping fever complex associated with intramuscularly or intravenously; for Pasteurella spp., Haemophilus spp., 100-milligram-per-milliliter solution, Klebsiella spp., foot-rot and diphtheria administer intramuscularly only. caused by Spherophorus necrophorus, Treatment of all diseases should be in- bacterial enteritis (scours) caused by stituted early and continue for 24 to 48 Escherichia coli, wooden tongue caused hours beyond remission of disease by Actinobacillus lignieresi, acute metri- symptoms, but not to exceed a total of tis, and wound infections caused by 4 consecutive days. Consult your vet- staphylococcal and streptococcal orga- erinarian if no improvement is noted nisms. within 48 hours. Do not inject more than 10 milliliters per site in adult cat- (ii) It is administered to cattle at a tle, reducing the volume according to dosage level of 3 to 5 milligrams per age and body size to 0.5 to 2 milliliters pound of body weight per day. It may in small calves. Exceeding the highest be administered intramuscularly or in- recommended dose of 5 milligrams per travenously from a 50 milligram per pound of body weight, administering at milliliter solution. It is administered recommended levels for more than 4 intravenously from a 100 milligram per consecutive days, and/or exceeding 10 milliliter solution. Severe foot-rot and milliliters intramuscularly per injec- the severe forms of the indicated dis- tion site may result in antibiotic resi- eases should be treated with 5 milli- dues beyond the withdrawal time. Dis- grams per pound of body weight. Treat- continue treatment at least 18 days ment should be continued 24 to 48 prior to slaughter. Not for use in lac- hours following remission of disease tating dairy cattle. symptoms, however, not to exceed a (ii) Swine—(a) Amount. Three to 5 total of 4 consecutive days. If no im- milligrams of oxytetracycline per provement is noted within 24 hours, pound of body weight per day. Sows: 3 consult a veterinarian. When injecting milligrams of oxytetracycline per the drug intramuscularly, do not inject pound of body weight, approximately 8 more than 10 milliliters per site in hours before farrowing or immediately adult cattle. Reduce the amount in- after completion of farrowing. jected at each site according to the size (b) Indications for use. For treatment of the animal. For very small calves do of bacterial enteritis (scours, not use more than 2 milliliters per in- colibacillosis) caused by Escherichia jection site. coli, pneumonia caused by Pasteurella (iii) Not for use in lactating dairy multocida, and leptospirosis caused by cattle. Discontinue treatment at least Leptospira pomona. Sows: as an aid in 19 days prior to slaughter. When ad- control of infectious enteritis (baby pig ministered intramuscularly within 30 scours, colibacillosis) in suckling pigs days of slaughter, muscle discoloration caused by Escherichia coli. may necessitate trimming of the injec- (c) Limitations. Administer tion site and surrounding tissues. intramuscularly. Do not inject more (d)(1) Specifications. The drug con- than 5 milliliters per site. Do not use tains 50 milligrams of oxytetracycline

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hydrochloride in each milliliter of ster- hours before farrowing or immediately ile solution. after farrowing. (2) Sponsor. See No. 054771 in (iii) In poultry (broilers, turkeys, and § 510.600(c) of this chapter. breeding chickens) as follows: (3) Conditions of use. (i) In beef cattle (a) It is used for the treatment of air and nonlactating dairy cattle as fol- sacculitis (air-sac disease, chronic res- lows: piratory disease) caused by Mycoplasma (a) It is used for the treatment of gallisepticum and Escherichia coli; fowl pneumonia and shipping fever complex cholera caused by Pasteurella multocida; associated with Pasteurella spp. and infectious sinusitis caused by Myco- Haemophilus spp.; foot-rot and diph- plasma gallisepticum; and infectious syn- theria caused by Spherophorus ovitis caused by Mycoplasma synoviae. necrophorus; bacterial enteritis (scours) (b) Administered subcutaneously to caused by Escherichia coli; wooden chickens 1 day to 2 weeks of age at 6.25 tongue caused by Actinobacillus milligrams of oxytetracycline per bird lignieresi; leptospirosis caused by per day diluted with 1 part of the drug Leptospira pomona; wound infections to 3 parts of sterile water; to chickens and acute metritis caused by staphy- 2 to 4 weeks of age using the same di- lococcal and streptococcal organisms. luted product at 12.5 milligrams of oxytetracycline per bird; to chickens 4 to 8 (b) Administer by intravenous or weeks of age without dilution at 25 intramuscular injection at 3 to 5 milli- milligrams of oxytetracycline per bird; grams of oxytetracycline per pound of to chickens 8 weeks of age (broilers and body weight per day. In the treatment light pullets) at 50 milligrams of oxy- of severe foot-rot and severe forms of tetracycline per bird; to adult chickens the indicated diseases, a dosage level of at 100 milligrams of oxytetracycline 5 milligrams per pound of body weight per bird. per day is recommended. (c) Administered subcutaneously to (c) If the labeling of the drug bears turkeys 1 day to 2 weeks of age and 2 to the statement ‘‘Federal law restricts 4 weeks of age at the same dosage as this drug to use by or on the order of a chickens; to turkeys 4 to 6 weeks of age licensed veterinarian,’’ it may include at 50 milligrams of oxytetracycline as additional directions for use in beef the undiluted product per bird; to tur- cattle and nonlactating dairy cattle for keys 6 to 9 weeks of age at 100 milli- the treatment of anaplasmosis caused grams of oxytetracycline per bird; to by Anaplasma marginale, and anthrax turkeys 9 to 12 weeks of age at 150 mil- caused by Bacillus anthracis in which ligrams of oxytetracycline per bird; to case the drug is given at 3 to 5 milli- turkeys 12 weeks of age and older at 200 grams of oxytetracycline per pound of milligrams of oxytetracycline per bird. body weight per day for anthrax, and at In light turkey breeds, no more than 25 5 milligrams per pound of body weight milligrams per pound of body weight is per day for anaplasmosis. administered. For the treatment of in- (ii) In swine as follows: fectious sinusitis in turkeys, 1⁄4 to 1⁄2 (a) It is used for the treatment of milliliter of the drug is injected di- bacterial enteritis (scours, rectly into each swollen sinus depend- colibacillosis) caused by Escherichia ing upon the age of the bird and the se- coli; pneumonia caused by Pasteurella verity of the condition. At the time multocida; and leptospirosis caused by that the sinuses are treated, the drug Leptospira pomona. Administered to should also be administered sows as an aid in the control of infec- subcutaneously to the birds according tious enteritis (baby pig scours, to the dosage schedule given in para- colibacillosis) in suckling pigs caused graph (d)(3)(iii)(c) of this section. If re- by Escherichia coli. filling of the sinuses occurs, the treat- (b) Administer by intramuscular in- ment may be repeated in 5 to 7 days. jection at 3 to 5 milligrams of oxytet- (iv) Treatment of all diseases should racycline per pound of body weight per be instituted early. Treatment should day to swine. Administered to sows at continue for 24 to 48 hours beyond the 3 milligrams of oxytetracycline per remission of disease symptoms, but not pound of body weight approximately 8 exceed a total of 4 consecutive days. If

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no improvement is noted within 24 to marginale and anthrax caused by Bacil- 48 hours, diagnosis and therapy should lus anthracis. be reevaluated. (c) Limitations. Administer (v) When injecting intramuscularly intramuscularly. Treatment of all dis- in adult livestock, do not inject more eases should be instituted early and than 10 milliliters at any one site. The continue for 24 to 48 hours beyond re- volume administered per injection site mission of disease symptoms, but not should be reduced according to age and to exceed a total of 4 consecutive days. body size so that 1 or 2 milliliters are Consult your veterinarian if no im- injected in smaller animals such as provement is noted within 48 hours. Do small calves and young pigs. Intra- not inject more than 10 milliliters per venous administration is recommended site in adult cattle, reducing the vol- in cattle when daily dosage exceeds 50 ume according to age and body size to milliliters. 1 to 2 milliliters in small calves. Ex- (vi) Treatment must be discontinued ceeding the highest recommended dose at least 5 days prior to slaughter for of 5 milligrams per pound of body chickens and turkeys and at least 22 weight per day, administering more days prior to slaughter for cattle and than the recommended number of swine. When administered treatments, and/or exceeding 10 milli- intramuscularly to animals within 30 liters intramuscularly or days of slaughter, muscle discoloration subcutaneously per injection site in may necessitate trimming of the injec- adult beef and dairy cattle may result tion site(s) and surrounding tissues in antibiotic residues beyond the with- during the dressing procedure. drawal period. Discontinue treatment (vii) Not for use in lactating dairy at least 15 days prior to slaughter. Not animals. Do not administer to laying for use in lactating dairy cattle. hens unless the eggs are used for hatch- (ii) Swine—(a) Amount. 3 to 5 milli- ing only. grams of oxytetracycline per pound of (e)(1) Specifications. Each milliliter of body weight per day. Sows: 3 milli- solution contains 100 milligrams of ox- grams of oxytetracycline per pound of ytetracycline hydrochloride. body weight, administered once, ap- (2) Sponsor. See No. 054771 in proximately 8 hours before farrowing § 510.600(c) of this chapter. or immediately after completion of (3) Conditions of use—(i) Beef cattle farrowing. and nonlactating dairy cattle—(a) (b) Indications for use. For treatment Amount. 3 to 5 milligrams of oxytetra- of bacterial enteritis (scours, cycline per pound of body weight per colibacillosis) caused by Escherichia day; 5 milligrams per pound of body coli, pneumonia caused by Pasteurella weight per day for treatment of multocida, and leptospirosis caused by anaplasmosis, severe foot-rot, and se- Leptospira pomona. Sows: as an aid in vere cases of other indicated diseases. control of infections enteritis (baby pig (b) Indications for use. Treatment of scours, colibacillosis) in suckling pigs diseases due to oxytetracycline-suscep- caused by Escherichia coli. tible organisms as follows: Pneumonia (c) Limitations. Administer and shipping fever complex associated intramuscularly. Do not inject more with Pasteurella spp. and Haemophilus spp., foot-rot and diphtheria caused by than 5 milliliters per site in adult Fusobacterium necrophorum, bacterial swine, reducing the volume according enteritis (scours) caused by Escherichia to age and body size to 1 to 2 milliliters coli, wooden tongue caused by in young pigs. Discontinue treatment Actinobacillus lignieresii, leptospirosis at least 22 days prior to slaughter. caused by Leptospira pomona, and (f) [Reserved] wound infections and acute metritis (g)(1) Specifications. Each milliliter of caused by Staphylococcus spp. and Strep- sterile solution contains 100 milligrams tococcus spp. If labeled for use by or on of oxytetracycline as oxytetracycline the order of a licensed veterinarian, it hydrochloride. may be used for the treatment of (2) Sponsor. See No. 054628 in anaplasmosis caused by Anaplasma § 510.600(c) of this chapter.

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(3) Conditions of use. The drug is used noted within 24 hours, consult a veteri- for the treatment of diseases due to ox- narian. Do not inject more than 5 mil- ytetracycline-susceptible organisms as liliters per site. Discontinue treatment follows: at least 20 days prior to slaughter. (i) Beef cattle, beef calves, nonlactating (h)(1) Specifications. Each milliliter of dairy cattle, and dairy calves—(a) sterile solution contains 50 or 100 milli- Amount. 3 to 5 milligrams of oxytetra- grams of oxytetracycline hydro- cycline per pound of body weight per chloride. day. (2) Sponsors. See No. 054628 in (b) Indications for use. For the treat- § 510.600(c) of this chapter for use of 50 ment of pneumonia and shipping fever and 100 milligrams per milliliter solu- complex associated with Pasteurella tion; and Nos. 016592 and 055529 in spp., Haemophilus spp., or Klebsiella spp. § 510.600(c) for use of 100 milligrams per (c) Limitations. Administer by milliliter solution. intramuscular, intravenous, or sub- (3) Conditions of use—(i) Amount. The cutaneous injection. In severe forms of drug is used in beef cattle, beef calves, the indicated diseases, administer 5 nonlactating dairy cattle, and dairy milligrams of oxytetracycline per calves as follows: 3 to 5 milligrams of pound of body weight per day. Continue oxytetracycline hydrochloride per treatment 24 to 48 hours following re- pound of body weight per day; 5 milli- mission of disease symptoms, not to grams per pound of body weight per exceed a total of 4 consecutive days. If day for treatment of severe forms of no improvement is noted within 48 the indicated diseases. hours, consult a veterinarian. Do not (ii) Indications for use. The drug is inject more than 10 milliliters per in- used for treatment of bacterial pneu- jection site intramuscularly in adult monia and shipping fever complex asso- cattle; no more than 1 milliliter per ciated with Pasteurella spp.; foot-rot site in calves weighing 100 pounds or and calf diphtheria caused by less. Do not slaughter cattle for 13 days Fusobacterium necrophorum bacterial after intramuscular or intravenous enterities (scours) caused by Esch- treatment, or 2 days after subcuta- erichia coli; wooden tongue caused by neous treatment. Exceeding the high- Actinobacillus lignieresi; wound infec- est recommended dosage or duration of tions, acute metrities, and traumatic treatment (not more than 4 consecu- injury caused by staphylococcal and tive days) may result in residues be- streptococcal organisms. yond the withdrawal period. A with- (iii) Limitations. Administer 50-milli- drawal period has not been established gram-per-milliliter solution for use of this product in intramuscularly; administer 100-milli- preruminating calves. Do not use in gram-per-milliliter solution intra- calves to be processed for veal. venously. Continue treatment 24 to 48 (ii) Swine—(a) Amount. 3 to 5 milli- hours following remission of disease grams of oxytetracycline per pound of symptoms, not to exceed a total of 4 body weight per day. Sows: Administer consecutive days. If no improvement is once 3 milligrams of oxytetracycline noted within 24 to 48 hours, consult a per pound of body weight, approxi- veterinarian for diagnosis and therapy. mately 8 hours before farrowing or im- When injecting the drug mediately after completion of intramuscularly, do no inject more farrowing. than 10 milliliters per site in adult cat- (b) Indications for use. For treatment tle. Reduce the volume administered of bacterial enteritis (scours, per injection site according to age and colibacillosis) caused by Escherichia body size. In calves weighing 100 coli, pneumonia caused by Pasteurella pounds or less, do no inject more than multocida, and leptospirosis caused by 2 milliliters intramuscularly per site. Leptospira pomona. Sows: As an aid in Discontinue treatment at least 22 days control of infectious enteritis (baby pig before slaughter. Not for use in lac- scours, colibacillosis) in suckling pigs tating dairy animals. caused by Escherichia coli. (i)(1) Specifications. Each milliliter of (c) Limitations. Administer sterile solution contains 50 milligrams intramuscularly. If no improvement is of oxytetracycline hydrochloride.

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(2) Sponsor. See No. 016592 in Fusobacterium necrophorum; bacterial § 510.600(c) of this chapter. enteritis (scours) caused by Escherichia (3) Conditions of use—(i) Amount. The coli; wooden tongue caused by drug is used in beef cattle, beef calves, Actinobacillus lignieresii; leptospirosis nonlactating dairy cattle, and dairy caused by Leptospira pomona; acute me- calves as follows: Administer 3 to 5 tritis and wound infections caused by milligrams of the oxytetracycline hy- staphylococcal and streptococcal orga- drochloride intramuscularly per pound nisms; if labeled for use by or on the of body weight per day. order of a licensed veterinarian, it may (ii) Indications for use. The drug is be used for treatment of anaplasmosis used for treatment of bacterial pneu- caused by Anaplasma marginale and an- monia and shipping fever complex asso- thrax caused by Bacillus anthracis. ciated with Pasteurella spp.; foot-rot (iii) Limitations. Administer by intra- and diptheria caused by Spherophorus venous injection. Treatment should be necrophorus; bacterial enteritis (scours) continued 24 to 48 hours following re- caused by Escherichia coli; wooden mission of disease symptoms, but not tongue caused by Actinobacillus to exceed a total of 4 consecutive days. lignieresi; wound infections and acute If no improvement occurs within 24 to metritis caused by staphylococcal and 48 hours, reevaluate diagnosis and ther- streptococcal organisms susceptible to apy. Discontinue use at least 19 days oxytetracycline. prior to slaughter. Not for use in lac- (iii) Limitations. In severe forms of tating dairy cattle. the indicated diseases, administer the equivalent of 5 milligrams of oxytetra- [40 FR 13858, Mar. 27, 1975] cycline hydrochloride per pound of EDITORIAL NOTE: For FEDERAL REGISTER ci- body weight per day. Continue treat- tations affecting § 522.1662a, see the List of ment 24 to 48 hours following remission CFR Sections Affected, which appears in the of disease symptoms, not to exceed a Finding Aids section of the printed volume total of 4 consecutive days. If no im- and at www.fdsys.gov. provement is noted within 24 to 48 § 522.1662b Oxytetracycline hydro- hours, consult a veterinarian for diag- chloride with lidocaine injection. nosis and therapy. In adult livestock, do not inject more than 10 milliliters (a) Specifications. The drug contains at any one site. Reduce the volume ad- 50 or 100 milligrams of oxytetracycline ministered per injection site according hydrochloride and 2 percent lidocaine to age and body size. In calves weigh- in each milliliter of sterile aqueous so- ing 100 pounds or less inject only 2 mil- lution. liliters per site. Discontinue treatment (b) Sponsor. See No. 054771 in at least 18 days before slaughter. Not § 510.600(c) of this chapter. for use in lactating dairy cattle. (c) Conditions of use. (1) The drug is (j) [Reserved] indicated for use in the treatment of (k)(1) Specifications. Each milliliter of diseases of dogs caused by pathogens sterile solution contains either 50 or sensitive to oxytetracycline hydro- 100 milligrams of oxytetracycline hy- chloride including treatment for the drochloride. following conditions in dogs caused by (2) Sponsor. See No. 061623 in susceptible microorganisms: Bacterial § 510.600(c) of this chapter. infections of the urinary tract caused (3) Conditions of use in beef cattle and by Hemolytic staphylococcus, Strepto- nonlactating dairy cattle—(i) Amount. 3 coccus spp., Bacterial pulmonary infec- to 5 milligrams per pound of body tions caused by Brucella bronchiseptica, weight daily, 5 milligrams per pound Streptococcus pyogenes, Staphylococcus for anaplasmosis, severe foot rot, and aureus, secondary bacterial infections severe forms of other diseases. caused by Micrococcus pyogenes var. (ii) Indications for use. Treatment of albus, Brucella bronchiseptica, Strepto- diseases due to oxytetracycline-suscep- coccus spp. tible organisms as follows: pneumonia (2) The drug is administered and shipping fever complex associated intramuscularly at a recommended with Pasteurella spp. and Haemophilus daily dosage to dogs at 5 milligrams spp.; foot rot and diphtheria caused by per pound of body weight administered

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in divided doses at 6 to 12 hour inter- (b) Sponsors. See Nos. 054771 and vals. Therapy should be continued for 061623 in § 510.600(c) of this chapter. at least 24 hours after all symptoms (c) Conditions of use—(1) Amount—(i) have subsided. Obstetrical. Administer drug intra- (3) Federal law restricts this drug to venously, intramuscularly, or use by or on the order of a licensed vet- subcutaneously under aseptic condi- erinarian. tions as indicated. The following dosages are recommended and may be re- [40 FR 13858, Mar. 27, 1975, as amended at 48 peated as conditions require: FR 30615, July 5, 1983; 79 FR 16192, Mar. 25, 2014] mL U.S.P. units § 522.1664 Oxytetracycline and Cats ...... 0.25 to 0.5 ...... 5 to 10. flunixin. Dogs ...... 0.25 to 1.5 ...... 5 to 30. Ewes, Sows ...... 1.5 to 2.5 ...... 30 to 50. (a) Specifications. Each milliliter Cows, Horses ...... 5.0 ...... 100. (mL) of solution contains 300 milligrams (mg) oxytetracycline base as (ii) Milk letdown. Intravenous admin- amphoteric oxytetracycline and 20 mg istration is desirable. The following flunixin base as flunixin meglumine. dosage is recommended and may be re- (b) Sponsor. See No. 055529 in peated as conditions require: § 510.600(c) of this chapter. mL U.S.P. units (c) Related tolerances. See §§ 556.286 and 556.500 of this chapter. Cows ...... 0.5 to 1.0 ...... 10 to 20. Sows ...... 0.25 to 1.0 ...... 5 to 20. (d) Conditions of use cattle—(1) Amount. Administer once as an (2) Indications for use. Oxytocin may intramuscular or subcutaneous injec- be used as a uterine contractor to pre- tion of 1 mL per 22 pounds (lb) body cipitate and accelerate normal parturi- weight (BW) (13.6 mg oxytetracycline tion and postpartum evacuation of and 0.9 mg flunixin per lb BW) where uterine debris. In surgery it may be retreatment of calves and yearlings for used postoperatively following cesar- bacterial pneumonia is impractical due ean section to facilitate involution and to husbandry conditions, such as cattle resistance to the large inflow of blood. on range, or where their repeated re- It will contract smooth muscle cells of straint is inadvisable. the mammary gland for milk letdown (2) Indications for use. For the treat- if the udder is in proper physiological ment of bacterial pneumonia associ- state. ated with Pasteurella spp. and for the (3) Limitations. Federal law restricts control of associated pyrexia in beef this drug to use by or on the order of a and nonlactating dairy cattle. licensed veterinarian. (3) Limitations. Discontinue treatment at least 21 days prior to slaughter [44 FR 63097, Nov. 2, 1979; 45 FR 1019, Jan. 4, of cattle. This drug product is not ap- 1980] proved for use in female dairy cattle 20 EDITORIAL NOTE: For FEDERAL REGISTER ci- months of age or older, including dry tations affecting § 522.1680, see the List of dairy cows. Use in these cattle may CFR Sections Affected, which appears in the cause drug residues in milk and/or in Finding Aids section of the printed volume and at www.fdsys.gov. calves born to these cows. A withdrawal period has not been established § 522.1684 Pegbovigrastim. in preruminating calves. Do not use in (a) Specifications. Each pre-filled, sin- calves to be processed for veal. Federal gle-dose syringe contains 15 milligrams law restricts this drug to use by or on of pegbovigrastim. the order of a licensed veterinarian. (b) Sponsor. See No. 058198 in [76 FR 3489, Jan. 20, 2011, as amended at 79 § 510.600(c) of this chapter. FR 16192, Mar. 25, 2014] (c) Conditions of use in cattle—(1) Amount. Administer the first dose (sy- § 522.1680 Oxytocin. ringe) by subcutaneous injection 7 days (a) Specifications. Each milliliter prior to the cow’s or heifer’s antici- (mL) of solution contains 20 USP units pated calving date. If necessary, the oxytocin. first dose may be administered within

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a range of 4 to 10 days prior to the an- (ii) Conditions of use. Treatment of ticipated calving date to accommodate bacterial infections susceptible to peni- management schedules. Administer the cillin G. second dose (syringe) by subcutaneous (iii) Limitations. Not for use in beef injection within 24 hours after calving. cattle within 30 days of slaughter. Do (2) Indications for use. For the reduc- not use in horses intended for human tion in the incidence of clinical mas- consumption. Federal law restricts this titis in the first 30 days of lactation in drug to use by or on the order of a li- periparturient dairy cows and censed veterinarian. periparturient replacement dairy heif- (2) Beef cattle—(i) Amount. 2 milli- ers. liters per 150 pounds of body weight (3) Limitations. Federal law restricts subcutaneously. Repeat dosage in 48 this drug to use by or on the order of a hours. licensed veterinarian. (ii) Conditions of use. (A) Treatment of bacterial pneumonia (Streptococcus [81 FR 36789, June 8, 2016, as amended at 81 spp., Actinomyces pyogenes, Staphy- FR 48702, July 26, 2016] lococcus aureus); upper respiratory infections such as rhinitis or pharyngitis § 522.1696 Penicillin G procaine (A. pyogenes); blackleg (Clostridium injectable dosage forms. chauvoei). (B) As in paragraph (d)(2)(ii)(A) of § 522.1696a Penicillin G benzathine and penicillin G procaine suspen- this section; and prophylaxis of bovine sion. shipping fever in 300- to 500-pound beef calves. (a) Specifications. Each milliliter of (iii) Limitations. Not for use within 30 aqueous suspension contains penicillin days of slaughter. For Nos. 000859, G benzathine and penicillin G procaine, 055529, and 061623: A withdrawal period each equivalent to 150,000 units of peni- has not been established for this prod- cillin G. uct in pre-ruminating calves. Do not (b) Sponsors. See sponsors in use in calves to be processed for veal. § 510.600(c) of this chapter for the conditions of use in paragraph (d) of this sec- [66 FR 711, Jan. 4, 2001, as amended at 68 FR 34534, June 10, 2003; 70 FR 21947, Apr. 28, 2005; tion as follows: 70 FR 50182, Aug. 26, 2005; 73 FR 16754, Mar. (1) Nos. 054771, 055529, and 061623 for 31, 2008; 75 FR 54017, Sept. 3, 2010; 77 FR 4897, use as in paragraph (d)(1) of this sec- Feb. 1, 2012; 78 FR 17597, Mar. 22, 2013; 79 FR tion. 16192, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016] (2) Nos. 016592, 055529, and 061623 for § 522.1696b Penicillin G procaine aque- use as in paragraphs (d)(2)(i), ous suspension. (d)(2)(ii)(A), and (d)(2)(iii) of this section. (a) Specifications. Each milliliter con- (3) No. 054771 for use as in paragraphs tains penicillin G procaine equivalent (d)(2)(i), (d)(2)(ii)(B), and (d)(2)(iii) of to 300,000 units of penicillin G. this section. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter as follows: (c) Related tolerances. See § 556.510 of (1) Nos. 016592, 054771, and 055529 for this chapter. use as in paragraph (d) of this section. (d) Conditions of use—(1) Horses, dogs, (2) No. 061623 for use as in paragraph and beef cattle—(i) Amount—(A) Beef (d)(2) of this section. cattle. 2 milliliters per 150 pounds of (c) Related tolerances. See § 556.510 of body weight intramuscularly or this chapter. subcutaneously. Repeat dosage in 48 (d) Conditions of use—(1) Dogs and hours. cats—(i) Amount. 10,000 units per pound (B) Horses. 2 milliliters per 150 pounds body weight daily by intramuscular in- of body weight intramuscularly. Re- jection at 24-hour intervals. Continue peat dosage in 48 hours. treatment at least 48 hours after symp- (C) Dogs. 1 milliliter per 10 to 25 toms disappear. pounds of body weight intramuscularly (ii) Indications for use. Treatment of or subcutaneously. Repeat dosage in 48 infections caused by penicillin-sen- hours. sitive organisms.

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(iii) Limitations. Federal law restricts caused by penicillin-susceptible orga- this drug to use by or on the order of a nisms such as Streptococci, licensed veterinarian. Staphylococci, and Corynebacteria. (2) Cattle, sheep, swine, and horses—(i) (3) Limitations. Not for use in food- Amount. 3,000 units per pound body producing animals. Federal law re- weight (1 milliliter per 100 pounds body stricts this drug to use by or on the weight) daily by intramuscular injec- order of a licensed veterinarian. tion. [57 FR 37333, Aug. 18, 1992, as amended at 79 (A) For Nos. 000859, 054771, 055529, and FR 16193, Mar. 25, 2014] 061623: Continue treatment at least 48 hours after symptoms disappear. § 522.1698 Pentazocine. (B) For No. 055529: Continue treat- (a) Specifications. Each milliliter of ment at least 1 day after symptoms solution contains pentazocine lactate disappear (usually 2 or 3 days). equivalent to 30 milligrams (mg) of (ii) Indications for use. Treatment of pentazocine base. cattle and sheep for bacterial pneu- (b) Sponsor. See No. 054771 in monia (shipping fever) caused by § 510.600(c) of this chapter. Pasteurella multocida; swine for erysipe- (c) Conditions of use—(1) Horses—(i) las caused by Erysipelothrix Amount. Administer 0.15 mg rhusiopathiae; and horses for strangles pentazocine base per pound of body caused by Streptococcus equi. weight daily by intravenous or (iii) Limitations. Not for use in horses intramuscular injection. In cases of se- intended for food. Milk that has been vere pain, a second dose is rec- taken during treatment and for 48 ommended by intramuscular injection hours after the last treatment must 10 to 15 minutes after the initial dose not be used for food. at the same level. (A) For Nos. 054771 and 061623: Do not (ii) Indications for use. For sympto- exceed 7 days of treatment in nonlac- matic relief of pain due to colic. tating dairy and beef cattle, sheep, and (iii) Limitations. Do not use in horses swine, or 5 days in lactating cattle. intended for human consumption. Fed- Discontinue treatment for the fol- eral law restricts this drug to use by or lowing number of days before slaugh- on the order of a licensed veterinarian. ter: Nonruminating cattle (calves)—7; (2) Dogs—(i) Amount. Administer 0.75 all other cattle—4; sheep—8; and to 1.50 mg of pentazocine base per swine—6. pound of body weight by intramuscular (B) For Nos. 000859 and 055529: Con- injection. tinue treatment at least 1 day after (ii) Indications for use. For ameliora- symptoms disappear (usually 2 or 3 tion of pain accompanying post- days). operative recovery, fracture, trauma, and spinal disorders. [66 FR 712, Jan. 4, 2001, as amended at 68 FR (iii) Limitations. Federal law restricts 34534, June 10, 2003; 68 FR 42589, July 18, 2003; this drug to use by or on the order of a 69 FR 17586, Apr. 5, 2004; 70 FR 16935, Apr. 4, 2005; 73 FR 14177, Mar. 17, 2008; 75 FR 54017, licensed veterinarian. Sept. 3, 2010; 78 FR 17597, Mar. 22, 2013; 79 FR [42 FR 31450, June 21, 1977, as amended at 42 16192, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016] FR 36995, July 19, 1977; 47 FR 5409, Feb. 5, 1982; 55 FR 23076, June 6, 1990; 79 FR 16193, § 522.1696c Penicillin G procaine in Mar. 25, 2014] oil. (a) Specifications. Each milliliter con- § 522.1704 Pentobarbital. tains penicillin G procaine equivalent (a) Specifications. Each milliliter of to 300,000 units of penicillin G. solution contains 64.8 milligrams (mg) (b) Sponsor. See No. 054771 in of sodium pentobarbital. § 510.600(c) of this chapter. (b) Sponsor. See No. 000061 in (c) Conditions of use—(1) Amount. Dogs § 510.600(c) of this chapter. and cats—10,000 units per pound of body (c) Conditions of use—(1) Amount. The weight once daily. Horses—3,000 units drug is administered intravenously ‘‘to per pound of body weight once daily. effect’’. For general surgical anes- (2) Indications for use. Treatment of thesia, the usual dose is 11 to 13 mg per infections of dogs, cats, and horses pound of body weight. For sedation,

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the usual dose is approximately 2 mg (iii) Limitations. Federal law restricts per pound of body weight. For relieving this drug to use by or on the order of a convulsive seizures caused by strych- licensed veterinarian. nine in dogs, the injection should be (2) Horses—(i) Amount. Administer by administered intravenously ‘‘to ef- intravenous injection 1 to 2 grams (g) fect’’. The drug may be administered per 1,000 pounds of body weight daily in intraperitoneally. When given three divided doses, not to exceed 4 g intraperitoneally, it is administered at daily. Limit intravenous administra- the same dosage level as for intra- tion to not more than 5 successive venous administration. days. (2) Indications for use. The drug is in- (ii) Indications for use. For the relief dicated for use as a general anesthetic of inflammatory conditions associated in dogs and cats. Although it may be with the musculoskeletal system. used as a general surgical anesthetic (iii) Limitations. Do not use in horses for horses, it is usually given at a intended for human consumption. Fed- lower dose to cause sedation and hyp- eral law restricts this drug to use by or nosis and may be supplemented with a on the order of a licensed veterinarian. local anesthetic. It may also be used in [79 FR 16193, Mar. 25, 2014] dogs for the symptomatic treatment of strychnine poisoning. § 522.1820 Pituitary luteinizing hor- (3) Limitations. Do not use in horses mone powder for injection. intended for human consumption. Fed- (a) Specifications. The drug is a eral law restricts this drug to use by or lyophilized pituitary extract. Each 6- on the order of a licensed veterinarian. milliliter vial contains an amount [79 FR 16193, Mar. 25, 2014] equivalent to 25 milligrams of standard pituitary luteinizing hormone and is § 522.1720 Phenylbutazone. reconstituted for use by addition of 5 milliliters of 0.9 percent aqueous so- (a) Specifications—(1) Each milliliter dium chloride solution. of solution contains 100 milligrams (b) Sponsor. No. 000061 in § 510.600(c) of (mg) of phenylbutazone. this chapter. (2) Each milliliter of solution con- (c) Conditions of use—(1) Amount. Cat- tains 200 mg of phenylbutazone. tle and horses: 25 milligrams; swine: 5 (b) Sponsors. See sponsor numbers in milligrams; sheep: 2.5 milligrams; and § 510.600(c) of this chapter for use as in dogs: 1.0 milligram. Preferably given paragraph (c) of this section: by intravenous injection, it may be ad- (1) No. 054771 for use of product de- ministered subcutaneously. Treatment scribed in paragraph (a)(1) as in para- may be repeated in 1 to 4 weeks, or as graph (c) of this section. indicated. (2) Nos. 000061, 000859, 054771, and (2) Indications for use. As an aid in the 061623 for use of product described in treatment of breeding disorders related paragraph (a)(2) as in paragraph (c) of to pituitary hypofunction in cattle, this section. horses, swine, sheep, and dogs. (3) Nos. 054628 and 058005 for use of (3) Limitations. Federal law restricts product described in paragraph (a)(2) as this drug to use by or on the order of a in paragraph (c)(2) of this section. licensed veterinarian. (c) Conditions of use—(1) Dogs—(i) [40 FR 13858, Mar. 27, 1975, as amended at 52 Amount. Administer by intravenous in- FR 7832, Mar. 13, 1987; 79 FR 16193, Mar. 25, jection 10 mg per pound of body weight 2014] daily in three divided doses, not to exceed 800 mg daily regardless of weight. § 522.1850 Polysulfated Limit intravenous administration to 2 glycosaminoglycan. successive days. Oral medication may (a) Specifications. (1) Each 1-milliliter follow. (mL) ampule of solution contains 250 (ii) Indications for use. It is used for milligrams (mg) polysulfated the relief of inflammatory conditions glycosaminoglycan. associated with the musculoskeletal (2) Each mL of solution packaged in system. 5-mL ampules or 20-, 30-, or 50-mL vials

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contains 100 mg polysulfated mg per pound of body weight. For glycosaminoglycan. small dogs and cats, sterile (b) Sponsor. See No. 010797 in pralidoxime chloride may be adminis- § 510.600(c) of this chapter. tered either intraperitoneally or (c) Special considerations. Federal law intramuscularly. A mild degree of restricts this drug to use by or on the atropinization should be maintained order of a licensed veterinarian. for at least 48 hours. Following severe (d) Conditions of use—(1) Horses—(i) poisoning, a second dose of sterile Indications for use. For the treatment of pralidoxime chloride may be given noninfectious degenerative and/or trau- after 1 hour if muscle weakness has not matic joint dysfunction and associated been relieved. lameness of the carpal and hock joints in horses. (2) Indications for use. It is used in (ii) Amount—(A) Intra-articular use horses, dogs, and cats as an antidote in (carpal): 250 mg once a week for 5 the treatment of poisoning due to weeks. those pesticides and chemicals of the (B) Intramuscular use (carpal and organophosphate class which have hock): 500 mg every 4 days for 28 days. anticholinesterase activity in horses, (iii) Limitations. Do not use in horses dogs, and cats. intended for human consumption. (3) Limitations. Federal law restricts (2) Dogs—(i) Indications for use. For this drug to use by or on the order of a control of signs associated with non- licensed veterinarian. infectious degenerative and/or traumatic arthritis of canine synovial [79 FR 16193, Mar. 25, 2014] joints. (ii) Amount. 2 mg per pound of body § 522.1870 Praziquantel. weight by intramuscular injection (a) Specifications. Each milliliter twice weekly for up to 4 weeks (max- (mL) of solution contains 56.8 milli- imum of 8 injections). grams of praziquantel. [72 FR 56896, Oct. 5, 2007, as amended at 74 FR (b) Sponsors. See Nos. 000859 and 67816, Dec. 21, 2009] 061623 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) § 522.1862 Pralidoxime powder for in- Amount. Administer by subcutaneous jection. or intramuscular injection for dogs and (a) Specifications. Each vial contains 1 puppies 5 pounds (lb) and under, 0.3 mL; gram (g) of pralidoxime chloride pow- for 6 to 10 lb, 0.5 mL; for 11 to 25 lb, 1.0 der for mixing with 20 cubic centi- mL; if over 25 lb, 0.2 mL/5 lb body meters of sterile water for injection. weight to a maximum of 3 mL. Each milliliter of constituted solution (ii) Indications for use. For removal of contains 50 milligrams (mg) canine cestodes Dipylidium caninum, pralidoxime chloride. Taenia pisiformis, and Echinococcus (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. granulosus, and removal and control of (c) Conditions of use—(1) Amount. Ad- canine cestode Echinococcus minister as soon as possible after expo- multilocularis. sure to the poison. Before administra- (iii) Limitations. Federal law restricts tion of the sterile pralidoxime chloride, the drug to use by or on the order of a atropine is administered intravenously licensed veterinarian. at a dosage rate of 0.05 mg per pound of (2) Cats—(i) Amount. Administer by body weight, followed by administra- subcutaneous or intramuscular injection of an additional 0.15 mg of atro- tion for cats and kittens under 5 lb, 0.2 pine per pound of body weight adminis- mL; 5 to 10 lb, 0.4 mL; 11 lb and over, tered intramuscularly. Then the appro- 0.6 mL maximum. priate dosage of sterile pralidoxime (ii) Indications for use. For removal of chloride is administered slowly intra- feline cestodes Dipylidium caninum and venously. The dosage rate for sterile Taenia taeniaeformis. pralidoxime chloride when administered to horses is 2 g per horse. When administered to dogs and cats, it is 25

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(iii) Limitations. Federal law restricts (c) Conditions of use in dogs—(1) the drug to use by or on the order of a Amount. Administer intravenously in a licensed veterinarian. dosage of 21⁄2 to 5 mg per pound of body weight, initially for shock and shock- [46 FR 10464, Feb. 3, 1981, as amended at 47 like states, followed by equal mainte- FR 6617, Feb. 16, 1982; 58 FR 42853, Aug. 12, 1993; 67 FR 79853, Dec. 31, 2002; 78 FR 17868, nance doses at 1-, 3-, 6-, or 10-hour in- Mar. 25, 2013; 81 FR 67151, Sept. 30, 2016] tervals as determined by the condition of the animal. § 522.1881 Prednisolone acetate. (2) Indications for use. Administer (a) Specifications. Each milliliter of when a rapid adrenal glucocorticoid and/or anti-inflammatory effect is nec- suspension contains 25 milligrams (mg) essary. of prednisolone acetate. (3) Limitations. Federal law restricts (b) Sponsor. See No. 000061 in this drug to use by or on the order of a § 510.600(c) of this chapter. licensed veterinarian. (c) Conditions of use—(1) Amount. The drug is administered to horses intra- [68 FR 59881, Oct. 20, 2003] articularly at a dosage level of 50 to 100 mg. The dose may be repeated when § 522.1884 Prednisolone sodium succinate. necessary. The drug is administered to dogs and cats intramuscularly at a dos- (a) Specifications. Each milliliter of age level of 10 to 50 mg. The dosage prednisolone sodium succinate injec- may be repeated when necessary. If the tion contains: Prednisolone sodium condition is of a chronic nature, an succinate equivalent in activity to 10, oral corticosteroid may be given as a 20, or 50 milligrams (mg) of prednis- maintenance dosage. The drug may be olone. given intra-articularly to dogs and cats (b) Sponsor. See No. 054771 in at a dosage level of 5 to 25 mg. The dose § 510.600(c) of this chapter for products may be repeated when necessary after 7 containing 10, 20, and 50 mg equivalent days for two or three doses. prednisolone activity per milliliter for (2) Indications for use. The drug is in- use in horses, dogs, and cats as pro- dicated in the treatment of dogs, cats, vided in paragraphs (c)(1)(i), (ii), and and horses for conditions requiring an (iii) of this section. anti-inflammatory agent. The drug is (c) Conditions of use—(1) Amount and indicated for the treatment of acute indications for use—(i) Horses. Admin- musculoskeletal inflammations such as ister 50 to 100 mg as an initial dose by bursitis, carpitis, and spondylitis. The intravenous injection over a period of drug is indicated as supportive therapy one-half to 1 minute, or by in nonspecific dermatosis such as sum- intramuscular injection, and may be mer eczema and atopy. The drug may repeated in inflammatory, allergic, or be used as supportive therapy pre- and other stress conditions at intervals of postoperatively and for various stress 12, 24, or 48 hours, depending upon the conditions when corticosteroids are re- size of the animal, the severity of the quired while the animal is being treat- condition and the response to treated for a specific condition. ment. (3) Limitations. Do not use in horses (ii) Dogs. Administer by intravenous intended for human consumption. Fed- injection at a range of 2.5 to 5 mg per eral law restricts this drug to use by or pound of body weight as an initial dose on the order of a licensed veterinarian. followed by maintenance doses at 1, 3, 6, or 10 hour intervals, as determined [79 FR 16194, Mar. 25, 2014] by the condition of the animal, for treatment of shock. § 522.1883 Prednisolone sodium phos- (iii) Dogs and cats. Administer by phate. intramuscular injection for treatment (a) Specifications. Each milliliter of of inflammatory, allergic, and less se- solution contains 20 milligrams (mg) vere stress conditions, where imme- prednisolone sodium phosphate (equiv- diate effect is not required, at 1 to 5 mg alent to 14.88 mg of prednisolone). ranging upward to 30 to 50 mg in large (b) Sponsor. See No. 061623 in breeds of dogs. Dosage may be repeated § 510.600(c) of this chapter. in 12 to 24 hours and continued for 3 to

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5 days if necessary. If permanent (2) Indications for use. It is used for corticosteroid effect is required, oral conditions requiring an anti-inflam- therapy with prednisolone tablets may matory agent. be substituted. (3) Limitations. Do not use in horses (2) Limitations. Do not use in horses intended for human consumption. Fed- intended for human consumption. Fed- eral law restricts this drug to use by or eral law restricts this drug to use by or on the order of a licensed veterinarian. on the order of a licensed veterinarian. [79 FR 16194, Mar. 25, 2014] [79 FR 16194, Mar. 25, 2014] § 522.1920 Prochlorperazine and § 522.1885 Prednisolone tertiary isopropamide. butylacetate. (a) Specifications. Each milliliter of (a) Specifications. Each milliliter of solution contains prochlorperazine suspension contains 20 milligrams (mg) edisylate equivalent to 4 milligrams of prednisolone tertiary butylacetate. (mg) prochlorperazine and isopropamide iodide equivalent to 0.28 (b) Sponsor. See No. 050604 in mg of isopropamide. § 510.600(c) of this chapter. (b) Sponsor. See No. 054771 in (c) Conditions of use—(1) Amount—(i) § 510.600(c) of this chapter. Horses: Administer by intramuscular (c) Conditions of use—(1) Amount. (i) injection 100 to 300 mg or by Dosage is administered by subcuta- intrasynovial injection at a dosage neous injection twice daily as follows: level of 50 to 100 mg. Retreatment of horses in 24 to 48 hours may be nec- Weight of animal in pounds Dosage in essary, depending on the general condi- milliliters tion of the animal and the severity and Up to 4 ...... 0.25 duration of the disease. 5 to 14 ...... 0.5–1 15 to 30 ...... 2–3 (ii) Dogs and cats: Administer by 30 to 45 ...... 3–4 intramuscular injection 1 mg per 5 45 to 60 ...... 4–5 pounds of body weight or Over 60 ...... 6 intrasynovially at a dosage level of 10 to 20 mg. (ii) Following the last injection, ad- (2) Indications for use. It is used as an minister prochlorperazine and anti-inflammatory agent in horses, isopropamide sustained release cap- dogs, and cats. sules as indicated. (2) Indications for use. For use in dogs (3) Limitations. Do not use in horses and cats in which gastrointestinal dis- intended for human consumption. Fed- turbances are associated with emo- eral law restricts this drug to use by or tional stress. on the order of a licensed veterinarian. (3) Limitations. Federal law restricts [79 FR 16194, Mar. 25, 2014] this drug to use by or on the order of a licensed veterinarian. § 522.1890 Sterile prednisone suspension. [79 FR 16194, Mar. 25, 2014] (a) Specifications. Each milliliter of § 522.1940 Progesterone and estradiol suspension contains 10 to 40 milligrams benzoate. (mg) of prednisone. (a) Sponsors. See sponsors in (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter for use as in § 510.600(c) of this chapter. paragraph (c) of this section: (c) Conditions of use—(1) Amount—(i) (1) No. 054771 for use as in paragraphs Horses. Administer 100 to 400 mg by (c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), intramuscular injection, repeating if (c)(2)(i)(A), (c)(2)(ii), (c)(2)(iii), and necessary. (c)(3) of this section. (ii) Dogs and cats. Administer 0.25 to (2) No. 058198 for use as in paragraphs 1.0 mg per pound of body weight by (c)(1) and (c)(2) of this section. intramuscular injection for 3 to 5 days (b) Related tolerances. See §§ 556.240 or until a response is noted. Treatment and 556.540 of this chapter. may be continued with an orally ad- (c) Conditions of use in cattle. It is ministered dose. used for implantation as follows:

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(1) Suckling beef calves—(i) Amount— progesterone and 20 mg estradiol ben- (A) 100 milligrams (mg) progesterone zoate. and 10 mg estradiol benzoate (one im- (ii) Indications for use. For additional plant consisting of 4 pellets, each pel- improvement in rate of weight gain. let containing 25 mg progesterone and (iii) Limitations. For subcutaneous ear 2.5 mg estradiol benzoate) per implant implantation. Safety and effectiveness dose. have not been established in veal (B) 100 mg progesterone and 10 mg es- calves. A withdrawal period has not tradiol benzoate (one implant con- been established for this product in sisting of 5 pellets, each of 4 pellets preruminating calves. Do not use in containing 25 mg progesterone and 2.5 calves to be processed for veal. mg estradiol benzoate, and 1 pellet containing 29 mg tylosin tartrate) per im- [69 FR 70055, Dec. 2, 2004, as amended at 77 plant dose. FR 31723, May 30, 2012; 79 FR 16194, Mar. 25, (ii) Indications for use. For increased 2014; 81 FR 48702, July 26, 2016] rate of weight gain. (iii) Limitations. For use in suckling § 522.1962 Promazine. beef calves (at least 45 days of age) up (a) Specifications. Each milliliter of to 400 pounds (lb) of body weight. For solution contains 50 milligrams (mg) subcutaneous ear implantation, one promazine hydrochloride. dose per animal. Do not use in bull (b) Sponsors. See sponsors in calves intended for reproduction. Safe- § 510.600(c) of this chapter for use as in ty and effectiveness have not been es- paragraph (c) of this section: tablished in veal calves. A withdrawal (1) No. 054771 for use as in paragraphs period has not been established for this (c)(1)(i)(A), (c)(1)(ii)(A), (c)(1)(iii), and product in preruminating calves. Do (c)(2) of this section. not use in calves to be processed for veal. (2) No. 061623 for use as in paragraphs (2) Steers—(i) Amount—(A) 200 mg pro- (c)(1)(i)(B), (c)(1)(ii)(B), and (c)(1)(iii) of gesterone and 20 mg estradiol benzoate this section. (one implant consisting of 8 pellets, (c) Conditions of use—(1) Horses—(i) each pellet containing 25 mg progester- Amount—(A) 0.2 to 0.5 milligrams per one and 2.5 mg estradiol benzoate) per pounds (mg/lb) body weight implant dose. intramuscularly or intravenously (B) 200 mg progesterone and 20 mg es- every 4 to 6 hours. tradiol benzoate (one implant con- (B) 0.2 to 0.5 mg/lb body weight intra- sisting of 9 pellets, each of 8 pellets venously as required. containing 25 mg progesterone and 2.5 (ii) Indications for use—(A) For use as mg estradiol benzoate, and 1 pellet con- a tranquilizer, preanesthetic, or for taining 29 mg tylosin tartrate) per im- minor operative procedures in conjunc- plant dose. tion with local anesthesia; and as ad- (ii) Indications for use. For increased junctive therapy for tetanus. rate of weight gain and improved feed (B) For use as a tranquilizer and efficiency. preanesthetic. (iii) Limitations. For animals weigh- (iii) Limitations. Do not use in horses ing 400 lb or more; for subcutaneous ear intended for human consumption. Fed- implantation, one dose per animal. eral law restricts this drug to use by or Safety and effectiveness have not been established in veal calves. A with- on the order of a licensed veterinarian. drawal period has not been established (2) Dogs and cats—(i) Amount. 1 to 2 for this product in preruminating mg/lb body weight intramuscularly or calves. Do not use in calves to be proc- intravenously every 4 to 6 hours. essed for veal. (ii) Indications for use. For use as a (3) Steers fed in confinement for slaugh- tranquilizer, preanesthetic, for minor ter—(i) Amount. Reimplant 200 mg pro- operative procedures in conjunction gesterone and 20 mg estradiol benzoate with local anesthesia, as adjunctive on approximately day 70 following an therapy for tetanus, and as an initial implant of 100 mg progesterone antiemetic prior to worming; or to pre- and 10 mg estradiol benzoate or 200 mg vent motion sickness in dogs.

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(iii) Limitations. Federal law restricts (3) Limitations. Federal law restricts this drug to use by or on the order of a this drug to use by or on the order of a licensed veterinarian. licensed veterinarian. [46 FR 18962, Mar. 27, 1981, as amended at 68 [75 FR 20269, Apr. 19, 2010, as amended at 75 FR 59881, Oct. 20, 2003; 70 FR 50183, Aug. 26, FR 38700, July 6, 2010; 78 FR 17868, Mar. 25, 2005; 79 FR 16194, Mar. 25, 2014] 2013; 79 FR 16195, Mar. 25, 2014; 80 FR 18776, Apr. 8, 2015; 81 FR 36789, June 8, 2016] § 522.2002 Propiopromazine. (a) Specifications. Each milliliter of § 522.2012 Prostalene. solution contains 5 or 10 milligrams (a) Specifications. Each milliliter of (mg) propiopromazine hydrochloride. solution contains 1 milligram of (b) Sponsor. See No. 054771 in prostalene. § 510.600(c) of this chapter. (b) Sponsor. No. 054771 in § 510.600(c) of (c) Conditions of use in dogs and cats— this chapter. (1) Amounts and indications for use. Ad- (c) Conditions of use in horses—(1) minister 0.05 to 0.5 mg per pound of Amount. Administer 5 micrograms per body weight by intravenous or kilogram of body weight as a single intramuscular injection for subcutaneous injection. tranquilization. Administer 0.25 mg per (2) Indications for use. For the control pound of body weight by intravenous of estrus in mares. injection as a preanesthetic. (3) Limitations. Do not use in horses (2) Limitations. Federal law restricts intended for human consumption. Fed- this drug to use by or on the order of a eral law restricts this drug to use by or licensed veterinarian. on the order of a licensed veterinarian. [79 FR 16195, Mar. 25, 2014] [79 FR 16195, Mar. 25, 2014]

§ 522.2005 Propofol. § 522.2063 Pyrilamine. (a) Specifications. Each milliliter of (a) Specifications. Each milliliter of emulsion contains 10 milligrams (mg) solution contains 20 milligrams (mg) of propofol. pyrilamine maleate. (b) Sponsors. See sponsor numbers in (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter. § 510.600(c) of this chapter for uses in (1) No. 086064 for use as in paragraphs paragraph (c) of this section. (c)(1), (c)(2)(i), and (c)(3) of this section. (1) No. 000061 for use as in paragraph (2) No. 054771 for use as in paragraph (c)(1)(i), (2), and (3) of this section. (c) of this section. (2) No. 061623 for use as in paragraph (c) Conditions of use in dogs and cats— (c)(1)(ii), (2), and (3) of this section. (1) Amount. Administer by intravenous (c) Conditions of use—(1) Amount—(i) injection according to label directions. Horses, 40 to 60 mg per 100 pounds (lbs) The use of preanesthetic medication body weight; foals, 20 mg/100 lbs body reduces propofol dose requirements. weight. Administer by intramuscular, (2) Indications for use—(i) As a single subcutaneous, or intravenous injection. injection to provide general anesthesia Dosage may be repeated every 6 to 12 for short procedures; for induction and hours whenever necessary. maintenance of general anesthesia (ii) Horses, 40 to 60 mg/100 lbs body using incremental doses to effect; for weight; foals, 20 mg/100 lbs body induction of general anesthesia where weight. Administer by slow intra- maintenance is provided by inhalant venous injection. Dosage may be re- anesthetics. peated every 6 to 12 hours if necessary. (ii) For the induction and mainte- (2) Indications for use. It is intended nance of anesthesia and for induction for treating horses in conditions in of anesthesia followed by maintenance which antihistaminic therapy may be with an inhalant anesthetic. expected to lead to alleviation of some signs of disease.

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(3) Limitations. Do not use in horses 100 mcg/kg BW intravenously as a intended for human consumption. Fed- preanesthetic. eral law restricts this drug to use by or (2) Indications for use. For use as a on the order of a licensed veterinarian. sedative and analgesic to facilitate handling, clinical examinations, clin- [79 FR 16195, Mar. 25, 2014] ical procedures, and minor surgical § 522.2075 Robenacoxib. procedures in adult horses; and for use as a preanesthetic prior to the induc- (a) Specifications. Each milliliter of tion of general anesthesia in adult solution contains 20 milligrams (mg) horses. robenacoxib. (3) Limitations. Do not use in horses (b) Sponsor. See No. 058198 in intended for human consumption. Fed- § 510.600(c) of this chapter. eral law restricts this drug to use by or (c) Conditions of use—(1) Dogs—(i) on the order of a licensed veterinarian. Amount. Administer 0.91 mg per pound (2 mg/kilogram (kg)) by subcutaneous [69 FR 47363, Aug. 5, 2004, as amended at 79 injection, once daily, for a maximum of FR 16195, Mar. 25, 2014] 3 days. After the initial subcutaneous § 522.2100 Selenium and vitamin E. dose, subsequent doses can be given by subcutaneous injection or as the oral (a)(1) Specifications. Each milliliter of tablet in dogs weighing at least 5.5 emulsion contains 5.48 milligrams (mg) pounds (2.5 kg) and at least 4 months of sodium selenite (equivalent to 2.5 mg age, for a maximum of 3 total doses selenium) and 50 mg of vitamin E (68 over 3 days, not to exceed 1 dose per I.U.) (as d-alpha tocopheryl acetate). day. See § 520.2075(c)(1) of this chapter. (2) Sponsor. See No. 000061 in (ii) Indications for use. For the control § 510.600(c) of this chapter. (3) —(i) of postoperative pain and inflamma- Conditions of use in horses Administer 1 milliliter (mL) tion associated with soft tissue surgery Amount. per (/) 100 pounds (lbs) of body weight in dogs at least 4 months of age for a by intravenous injection or by deep maximum of 3 days. intramuscular injection in divided (iii) Limitations. Federal law restricts doses in two or more sites in the glu- this drug to use by or on the order of a teal or cervical muscles. Administra- licensed veterinarian. tion may be repeated at 5 to 10 day in- (2) Cats—(i) Amount. Administer 0.91 tervals. mg per pound (2 mg/kg) by subcuta- (ii) Indications for use. For the pre- neous injection, once daily, for a max- vention and treatment of selenium-to- imum of 3 days. copherol deficiency syndrome in (ii) Indications for use. For the control horses. of postoperative pain and inflamma- (iii) Limitations. Do not use in horses tion associated with orthopedic sur- intended for human consumption. Fed- gery, ovariohysterectomy, and castra- eral law restricts this drug to use by or tion in cats at least 4 months of age for on the order of a licensed veterinarian. a maximum of 3 days. (b)(1) Specifications. Each milliliter (iii) Limitations. Federal law restricts contains 2.19 mg of sodium selenite this drug to use by or on the order of a (equivalent to 1 mg of selenium), 50 mg licensed veterinarian. of vitamin E (68 I.U.) (as d-alpha [80 FR 61297, Oct. 13, 2015, as amended at 82 tocopheryl acetate). FR 12170, Mar. 1, 2017] (2) Sponsor. See No. 000061 in § 510.600(c) of this chapter. § 522.2076 Romifidine. (3) Conditions of use in dogs—(i) (a) Specifications. Each milliliter of Amount. Administer by subcutaneous solution contains 10 milligrams (mg) or intramuscular injection in divided romifidine hydrochloride. doses in two or more sites at 1 mL/20 (b) Sponsor. See No. 000010 in lbs of body weight with a minimum § 510.600(c) of this chapter. dosage of 1⁄4 mL and a maximum dosage (c) Conditions of use in horses—(1) of 5 mL. The dose is repeated at 3-day Amount. 40 to 120 micrograms per kilo- intervals until a satisfactory thera- gram of body weight (mcg/kg BW) in- peutic response is observed. A mainte- travenously for sedation and analgesia; nance regimen is then initiated which

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consists of 1 mL per 40 lbs of body pounds of body weight during the mid- weight with a minimum dosage of 1⁄4 dle third of gestation, and 30 days be- mL which is repeated every 3 days or 7 fore calving. Weanling calves: 1 milli- days, or longer, as required to main- liter per 200 pounds of body weight. tain continued improvement or an (ii) Indications for use. Weanling asymptomatic condition; or the drug calves and breeding beef cows: For the may be used in capsule form for oral prevention and treatment of selenium- maintenance therapy. tocopherol deficiency syndrome. (ii) Indications for use. As an aid in al- (iii) Limitations. For subcutaneous or leviating and controlling inflamma- intramuscular use. Discontinue use 30 tion, pain, and lameness associated days before treated cattle are slaugh- with certain arthropathies in dogs. tered for human consumption. Federal (iii) Limitations. Federal law restricts law restricts this drug to use by or on this drug to use by or on the order of a the order of a licensed veterinarian. licensed veterinarian. (e)(1) Specifications. Each milliliter (c)(1) Specifications. Each milliliter contains 0.55 milligram selenite sodium contains 2.19 milligrams of selenite so- (equivalent to 0.25 milligram sele- dium (equivalent to 1 milligram selenium), 50 milligrams (68 U.S.P. units) nium), 50 milligrams vitamin E (68 vitamin E. U.S.P. units). (2) Sponsor. See No. 000061 in (2) Sponsor. See No. 000061 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (3) Conditions of use—(i) Dosage. New- (3) —(i) Conditions of use Dosage. born lambs: 1 milliliter. Lambs 2 weeks Calves: 2.5 to 3.75 milliliters per 100 of age or older: 4 milliliters. Baby pigs: pounds of body weight. Lambs 2 weeks 1 milliliter (or treat the sow during the of age or older: 1 milliliter per 40 last week of pregnancy). pounds, minimum 1 milliliter. Ewes: 2.5 (ii) Indications for use. Lambs: for pre- milliliters per 100 pounds. Sows: 1 mil- vention and treatment of white muscle liliter per 40 pounds. Weanling pigs: 1 disease (selenium-tocopherol deficiency milliliter per 40 pounds, minimum 1 syndrome). Baby pigs: an aid in the milliliter. prevention and treatment of selenium- (ii) Indications for use. Calves, lambs, tocopherol deficiency. and ewes: prevention and treatment of white muscle disease (selenium-tocoph- (iii) Limitations. For subcutaneous or erol deficiency syndrome). Sows and intramuscular use only. Discontinue weanling pigs: an aid in the prevention use 14 days before treated animals are and treatment of selenium-tocopherol slaughtered for human consumption. deficiency. Federal law restricts this drug to use (iii) Limitations. For subcutaneous or by or on the order of a licensed veteri- intramuscular use. Not for use in new- narian. born pigs. Do not use in pregnant ewes. [40 FR 13858, Mar. 27, 1975, as amended at 52 Calves: Discontinue use 30 days before FR 7832, Mar. 13, 1987; 57 FR 21209, May 19, treated calves are slaughtered for 1992; 58 FR 57556, Oct. 26, 1993; 60 FR 57833, human consumption. Lambs, ewes, Nov. 22, 1995; 64 FR 27916, May 24, 1999; 79 FR sows, or pigs: Discontinue use 14 days 16195, Mar. 25, 2014] before treated lambs, ewes, sows, or pigs are slaughtered for human con- § 522.2112 Sometribove zinc suspension. sumption. Federal law restricts this drug to use by or on the order of a li- (a) Specifications. Each single-dose sy- censed veterinarian. ringe contains 500 milligrams (mg) (d)(1) Specifications. Each milliliter sometribove zinc in a prolonged-release contains 10.95 milligrams selenite so- suspension. dium (equivalent to 5 milligrams sele- (b) Sponsor. See No. 058198 in nium), 50 milligrams vitamin E (68 § 510.600(c) of this chapter. U.S.P. units). (c) Conditions of use—(1) Amount. In- (2) Sponsors. See Nos. 000061 and 054771 ject 500 mg every 14 days starting dur- in § 510.600(c) of this chapter. ing the 9th or 10th week (57 to 70 days) (3) Conditions of use—(i) Dosage. after calving and continue until the Breeding beef cows: 1 milliliter per 200 end of lactation.

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(2) Indications for use. To increase (c) Special considerations. The quan- production of marketable milk in tity of spectinomycin referred to in healthy lactating dairy cows. this section refers to the equivalent (3) Limitations. Use in lactating dairy weight of base activity for the drug. cows only. Safety to replacement bulls (d) Conditions of use. It is adminis- born to treated dairy cows has not been tered as spectinomycin dihydrochloride established. Inject subcutaneously. pentahydrate as follows: Avoid injections within 2 weeks of ex- (1) Subcutaneously in the treatment pected slaughter to minimize injection of 1-to-3-day-old turkey poults at the site blemishes on carcass. There is no rate of 1 to 2 milligrams per poult as an milk discard or preslaughter with- aid in the prevention of mortality asso- drawal period. Use may reduce preg- ciated with Arizona group infection. nancy rates and increase days open. (2) Subcutaneously in the treatment Treated cows are at an increased risk of 1-to-3-day old: for mastitis and higher milk somatic (i) Turkey poults at the rate of 5 mil- cell counts. Use care to differentiate ligrams per poult as an aid in the con- increased body temperature due to use trol of chronic respiratory disease of this product from an increased body (CRD) associated with E. coli. temperature that may occur due to ill- (ii) Baby chicks at the rate of 2.5 to ness. Cows treated with this product 5 milligrams per chick as an aid in the may have more enlarged hocks and dis- control of mortality and to lessen se- orders of the foot region. Use may re- verity of infections caused by M. duce hemoglobin and hematocrit val- synoviae, S. typhimurium, S. infantis, ues during treatment. Human warning: and E. coli. Avoid prolonged or repeated contact (3) Intramuscularly in the treatment with eyes and skin. of dogs: [58 FR 59947, Nov. 12, 1993, as amended at 67 (i) At a dosage level of 2.5 milligrams FR 18085, Apr. 15, 2002; 68 FR 62006, Oct. 31, to 5.0 milligrams per pound of body 2003; 74 FR 53164, Oct. 16, 2009; 81 FR 48702, weight twice daily. Treatment may be July 26, 2016] continued for 4 days. For treatment of infections caused by gram-negative and § 522.2120 Spectinomycin gram-positive organisms susceptible to dihydrochloride injection. spectinomycin. (a) Specifications. The spectinomycin (ii) Federal law restricts this drug to dihydrochloride pentahydrate used in use by or on the order of a licensed vet- manufacturing the drug is the anti- erinarian. biotic substance produced by the (4) Administer single injection of 0.1 growth of Streptomyces flavopersicus milliliter (10 milligrams) (var. Abbott) or the same antibiotic subcutaneously in nape of neck of 1- to substance produced by any other 3-day-old turkey poults as an aid in means. Each milliliter of the drug con- control of airsacculitis associated with tains the following amount of M. meleagridis sensitive to spectinomycin activity from spectinomycin. spectinomycin dihydrochloride pentahydrate: [40 FR 13858, Mar. 27, 1975, as amended at 43 FR 9273, Mar. 7, 1978; 46 FR 18964, Mar. 27, (1) 5 milligrams when used as pro- 1981; 47 FR 14149, Apr. 2, 1982; 61 FR 5507, Feb. vided in paragraph (d)(1) of this sec- 13, 1996; 61 FR 31028, June 19, 1996; 65 FR tion. 45877, July 26, 2000; 66 FR 22118, May 3, 2001; (2) [Reserved] 79 FR 16195, Mar. 25, 2014; 81 FR 22524, Apr. 18, (3) 100 milligrams when used as pro- 2016] vided in paragraphs (d) (2), (3), and (4) of this section. § 522.2121 Spectinomycin sulfate. (b) Sponsor. In § 510.600 of this chap- (a) Specifications. Each milliliter of ter, see No. 016592 for conditions of use solution contains spectinomycin sul- as in paragraph (d) of this section, and fate tetrahydrate equivalent to 100 mil- see No. 054771 for conditions of use as ligrams (mg) spectinomycin. in paragraph (d)(2) and (d)(4) of this (b) Sponsor. See No. 054771 in section. § 510.600(c) of this chapter.

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(c) Related tolerances. See § 556.600 of (c) Related tolerances. See § 556.630 of this chapter. this chapter. (d) Conditions of use in cattle—(1) (d) Conditions of use in calves. It is Amount. 10 to 15 mg per kilogram of used as follows: body weight at 24-hour intervals for 3 (1) Amount. Administer 30 to 45 mg to 5 consecutive days. per pound (/lb) of body weight in di- (2) Indications for use. For the treat- vided doses by twice daily injection for ment of bovine respiratory disease 1 to 5 days. (pneumonia) associated with (2) Indications for use. For the treat- Mannheimia haemolytica, Pasteurella ment of diarrhea caused or complicated multocida, and Histophilus somni. by Escherichia coli (colibacillosis). (3) Limitations. Do not slaughter with- (3) Limitations. Treated calves must in 11 days of last treatment. Do not use not be slaughtered for food during in female dairy cattle 20 months of age treatment or for 5 days after the last or older. Use in this class of cattle may treatment. A withdrawal period has cause residues in milk. A withdrawal not been established for this product in period has not been established for this preruminating calves. Do not use in product in preruminating calves. Do calves to be processed for veal. not use in calves to be processed for [75 FR 10167, Mar. 5, 2010] veal. Federal law restricts this drug to use by or on the order of a licensed vet- § 522.2220 Sulfadimethoxine. erinarian. (a) Specifications. Each milliliter of solution contains: [72 FR 31178, June 6, 2007, as amended at 79 FR 16195, Mar. 25, 2014] (1) 100 milligrams (mg) of sulfadimethoxine sodium. § 522.2150 Stanozolol. (2) 400 mg of sulfadimethoxine sodium. (a) Specifications. Each milliliter of (b) Sponsors. See sponsor numbers in suspension contains 50 milligrams (mg) § 510.600(c) of this chapter for use as in of stanozolol. paragraph (d) of this section. (b) Sponsor. No. 054771 in § 510.600(c) of (1) No. 054628 for use of the product this chapter. described in paragraph (a)(1) as in para- (c) Conditions of use—(1) Amount—(i) graph (d)(1) of this section. Dogs and cats. For cats and small (2) No. 054771 for use of the product breeds of dogs: 25 mg. For larger dogs: described in paragraph (a)(2) as in para- 50 mg. Administer by deep graphs (d)(2), (3), and (4) of this section. intramuscular injection in the thigh at (3) Nos. 016592, 057561, and 061623 for weekly intervals, for several weeks. use of the product described in para- (ii) Horses. Administer 25 mg per 100 graph (a)(2) as in paragraph (d)(4) of pounds of body weight by deep this section. intramuscular injection in the gluteal (c) Related tolerances. See § 556.640 of region at weekly intervals, for not this chapter. more than 4 weeks. (d) Conditions of use—(1) Dogs—(i) (2) Indications for use. For use as an Amount. Administer by subcutaneous, anabolic steroid treatment. intramuscular, or intravenous injec- (3) Limitations. Do not use in horses tion at an initial dose of 25 mg per intended for human consumption. Fed- pound of body weight followed by 12.5 eral law restricts this drug to use by or mg per pound of body weight every 24 on the order of a licensed veterinarian. hours thereafter. Continue treatment until the animal is free from symptoms [79 FR 16195, Mar. 25, 2014] for 48 hours. (ii) Indications for use. For use in the § 522.2200 Sulfachlorpyridazine. treatment of sulfadimethoxine-suscep- (a) Specifications. Each milliliter of tible bacterial infections in dogs. solution contains sodium (iii) Limitations. Federal law restricts sulfachlorpyridazine equivalent to 200 this drug to use by or on the order of a milligrams (mg) sulfachlorpyridazine. licensed veterinarian. (b) Sponsor. See No. 000010 in (2) Dogs and cats—(i) Amount. Admin- § 510.600(c) of this chapter. ister by intravenous or subcutaneous

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injection at an initial dose of 55 mg per § 522.2240 Sulfaethoxypyridazine. kilogram of body weight followed by (a) Specifications. The drug is an aque- 27.5 mg per kilogram of body weight ous solution of sulfaethoxypyridazine. every 24 hours. (b) Sponsor. See No. 054771 in (ii) Indications for use. For the treat- § 510.600(c) of this chapter. ment of respiratory, genitourinary (c) Related tolerances. See § 556.650 of tract, enteric, and soft tissue infec- this chapter. tions when caused by Streptococci, (d) Conditions of use in cattle—(1) Staphylococci, Escherichia, Salmonella, Amount. Administer 2.5 grams per 100 Klebsiella, Proteus, or Shigella orga- pounds of body weight per day by in- nisms sensitive to sulfadimethoxine, travenous injection for not more than 4 and in the treatment of canine bac- days; or first treatment may be fol- terial enteritis associated with coccidi- lowed by 3 days of treatment with osis and canine Salmonellosis. sulfaethoxypyridazine in drinking (iii) Limitations. Federal law restricts water or tablets in accordance with this drug to use by or on the order of a §§ 520.2240a(e) and 520.2240b(e) of this licensed veterinarian. chapter. (3) Horses—(i) Amount. Administer by (2) Indications for use. For treatment intravenous injection at an initial dose of respiratory infection (pneumonia, of 55 mg per kilogram of body weight shipping fever), foot rot, calf scours; as followed by 27.5 mg per kilogram of adjunctive therapy in septicemia ac- body weight every 24 hours until the companying mastitis and metritis. patient is asymptomatic for 48 hours. (3) Limitations. Do not treat within 16 (ii) Indications for use. For the treat- days of slaughter. Milk that has been ment of respiratory disease caused by taken from animals during treatment Streptococcus equi (strangles). and for 72 hours (6 milkings) after the latest treatment must not be used for (iii) Limitations. Do not use in horses food. Federal law restricts this drug to intended for human consumption. Fed- use by or on the order of a licensed vet- eral law restricts this drug to use by or erinarian. on the order of a licensed veterinarian. (4) Cattle—(i) Amount. Administer an [79 FR 16196, Mar. 25, 2014] initial dose of 25 mg per pound of body weight by intravenous injection fol- § 522.2260 Sulfamethazine. lowed by 12.5 mg per pound of body (a) Specifications. Each milliliter weight every 24 hours until the animal (mL) of solution contains 250 milli- is asymptomatic for 48 hours. grams (mg) sulfamethazine sodium. (ii) Indications for use. For the treat- (b) Sponsor. See No. 016592 in ment of bovine respiratory disease § 510.600(c) of this chapter. complex (shipping fever complex) and (c) Related tolerances. See § 556.670 of bacterial pneumonia associated with this chapter. Pasteurella spp. sensitive to (d) Conditions of use in cattle—(1) sulfadimethoxine; necrotic Amount. Initially administer 20 mL for pododermatitis (foot rot) and calf diph- each 50 pounds (lb) of body weight (100 theria caused by Fusobacterium mg/lb) by intravenous injection, fol- necrophorum sensitive to lowed by 20 mL per 100 lb of body sulfadimethoxine. weight (50 mg/lb) by intravenous injection, daily thereafter. Treatment (iii) Limitations. Milk taken from ani- should not exceed a total of 5 consecu- mals during treatment and for 60 hours tive days. (5 milkings) after the latest treatment (2) Indications for use. For cattle for must not be used for food. Do not ad- treatment of bacterial pneumonia and minister within 5 days of slaughter. A bovine respiratory disease complex withdrawal period has not been estab- (shipping fever complex) (Pasteurella lished for this product in spp.), colibacillosis (bacterial scours) preruminating calves. Do not use in (Escherichia coli), necrotic calves to be processed for veal. pododermatitis (foot rot) [79 FR 16196, Mar. 25, 2014, as amended at 81 (Fusobacterium necrophorum), calf diph- FR 22524, Apr. 18, 2016] theria (Fusobacterium necrophorum),

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acute mastitis and acute metritis § 522.2404 Thialbarbitone sodium for (Streptococcus spp.) when caused by one injection. or more pathogenic organisms sen- (a) Specifications. Thialbarbitone so- sitive to sulfamethazine. dium for injection when reconstituted (3) Limitations. Withdraw medication with sterile distilled water provides 94 from cattle 10 days prior to slaughter. milligrams of thialbarbitone sodium Do not use in female dairy cattle 20 per milliliter of solution. months of age or older. Federal law re- (b) Sponsor. See No. 054771 in stricts this drug to use by or on the § 510.600(c) of this chapter. order of a licensed veterinarian. (c) Conditions of use. (1) The drug is administered as a general anesthetic in [46 FR 62055, Dec. 22, 1981, as amended at 67 surgical procedures on dogs, cats, FR 78355, Dec. 24, 2002; 75 FR 10167, Mar. 5, swine, sheep, cattle, and horses. The 2010; 76 FR 53051, Aug. 25, 2011; 81 FR 17608, Mar. 30, 2016] drug is used for procedures of relatively short duration. However, the § 522.2340 Sulfomyxin. period of anesthesia can be lengthened by slower initial injection and supple- (a) Specifications. Sulfomyxin for in- mental administration during surgery. jection is sterile. It is derived from the (2) It is administered intravenously. antibiotic substance produced by the The drug is injected slowly to dogs, growth of Bacillus polymyxa or is the cats, cattle, sheep, and swine. For same substance produced by any other horses, it is recommended that a pre- means. anesthetic sedation be administered to (b) Sponsor. See No. 054771 in the horse 30 minutes before the drug is § 510.600(c) of this chapter. administered. The drug is then injected (c) Special considerations. The quan- rapidly and completely. The drug is tities of antibiotic in paragraph (e) of used at the following dosage levels: this section refer to the activity of the Dosage in appropriate standard. Weight of animal Species in pounds milligrams (d) Related tolerances. See § 556.700 of per pound this chapter. Dog ...... Over 50 ...... 14.1 (e) Conditions of use. (1) It is used or Do ...... 30–50 ...... 18.8 intended for use in chickens and tur- Do ...... 10–30 ...... 23.5 Do ...... Under 10 ...... 28.2 keys as an aid in the treatment of dis- Cat ...... 31.3–37.6 ease caused or complicated by E. coli, Horse ...... 6.3–7.8 such as colibacillosis and complicated Cattle and swine ...... 6.7–9.4 Calves and sheep ...... 9.4–11.8 chronic respiratory disease. (2) It is administered by subcuta- (3) Federal law restricts this drug to neous injection as follows: use by or on the order of a licensed veterinarian. Antibiotic activity [40 FR 13858, Mar. 27, 1975, as amended at 79 Age of birds in days Chickens Turkeys (units) (units) FR 16196, Mar. 25, 2014]

1 to 14 ...... 12,500 12,500 § 522.2424 Thiamylal. 15 to 28 ...... 25,000 25,000 29 to 63 ...... 50,000 50,000 (a) Specifications. The drug is a sterile Over 63 ...... 50,000 100,000 powder. It is reconstituted with sterile distilled water, water for injection, or (3) A second injection may be given 3 sodium chloride injection, to a desired days later if symptoms persist. concentration of 0.5 to 4 percent so- (4) Not for use in laying hens; do not dium thiamylal. treat chickens within 5 days of slaugh- (b) Sponsors. See Nos. 054628 and ter; do not treat turkeys within 7 days 054771 in § 510.600(c) of this chapter. of slaughter. (c) Conditions of use—(1) Amount. Ad- minister by intravenous injection to ef- [40 FR 13858, Mar. 27, 1975, as amended at 79 fect. The average single dose is: FR 16196, Mar. 25, 2014] (i) Dogs and cats: 8 milligrams (mg) per pound of body weight (when used

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with a preanesthetic, generally one- pentobarbital powder for dilution with half the normal dose). sterile water for injection. (ii) Swine: 40 mg per 5 pounds (lbs) of (b) Sponsor. See No. 061623 in body weight. § 510.600(c) of this chapter. (iii) Horses: Light anesthesia, 1 gram (c) Conditions of use—(1) Amount. For per 500 lbs to 1,100 lbs of body weight; total anesthesia, it is given at approxi- deep anethesia, 1 gram per 300 lbs of mately 10 to 12 mg per pound of body body weight (40 mg/12 lbs of body weight over a period of 3.5 to 5 min- weight). utes. When preanesthetic medication is (iv) Cattle: Short duration, 20 mg/5 lbs used, wait at least an hour before ad- of body weight; longer duration, 40 mg/ ministering thiopental and sodium pen- 7 lbs of body weight. tobarbital for injection, and the dosage (2) Indications for use. It is used as an necessary for anesthesia is reduced. ultra-short-acting anesthetic in dogs, Usually 1⁄2 to 2⁄3 the normal amount is cats, swine, horses, and cattle. adequate. (3) Limitations. Do not use in horses (2) Indications for use. It is used as an intended for human consumption. Fed- anesthetic for intravenous administra- eral law restricts this drug to use by or tion to dogs and cats during short to on the order of a licensed veterinarian. moderately long surgical procedures. (3) Limitations. Federal law restricts [79 FR 16196, Mar. 25, 2014] this drug to use by or on the order of a § 522.2444 Thiopental injectable dos- licensed veterinarian. age forms. [79 FR 16197, Mar. 25, 2014]

§ 522.2444a Thiopental powder for in- § 522.2460 Tildipirosin. jection. (a) Specifications. Each milliliter of (a) Specifications. The drug contains solution contains: sodium thiopental powder for constitu- (1) 180 milligrams (mg) tildipirosin. tion with sterile water for injection. (2) [Reserved] (b) Sponsor. See No. 054771 in (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (c) Related tolerances. See § 556.733 of (1) Amount. Administer by intravenous this chapter. injection as follows: (d) Conditions of use—(1) Cattle—(i) (i) 6 to 9 milligrams (mg) per pound Amount. Administer 4 mg/kg of body- of body weight for brief anesthesia (6 to weight one time by subcutaneous injec- 10 minutes). tion in the neck. (ii) 10 to 12 mg per pound of body (ii) Indications for use. For the treat- weight for anesthesia of 15 to 25 min- ment of bovine respiratory disease utes duration. (BRD) associated with Mannheimia (2) Indications for use. It is used as an haemolytica, Pasteurella multocida, and anesthetic for intravenous administra- Histophilus somni in beef and non-lac- tion to dogs and cats during short to tating dairy cattle; and for the control moderately long surgical and other of respiratory disease in beef and non- procedures. It is also used to induce an- lactating dairy cattle at high risk of esthesia in dogs and cats which then developing BRD associated with M. have surgical anesthesia maintained by haemolytica, P. multocida, and H. somni. use of a volatile anesthetic. (iii) Limitations. Cattle intended for (3) Limitations. Federal law restricts human consumption must not be this drug to use by or on the order of a slaughtered within 21 days from the licensed veterinarian. last treatment. Do not use in female [79 FR 16196, Mar. 25, 2014] dairy cattle 20 months of age or older. A withdrawal period has not been es- § 522.2444b Thiopental and pento- tablished for this product in barbital powder for injection. preruminating calves. Do not use in (a) Specifications. Each gram of pow- calves to be processed for veal. Federal der contains 750 milligrams (mg) of so- law restricts this drug to use by or on dium thiopental and 250 mg of sodium the order of a licensed veterinarian.

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(2) [Reserved] (3) Limitations. Federal law restricts this drug to use by or on the order of a [77 FR 39391, July 3, 2012] licensed veterinarian. § 522.2470 Tiletamine and zolazepam [79 FR 16197, Mar. 25, 2014, as amended at 80 for injection. FR 34279, June 16, 2015; 82 FR 58556, Dec. 13, (a) Specifications. The drug is a sterile 2017] powder. Each milliliter of constituted § 522.2471 Tilmicosin. solution contains tiletamine hydrochloride equivalent to 50 milligrams (a) Specifications. Each milliliter of (mg) of tiletamine base and zolazepam solution contains 300 milligrams (mg) hydrochloride equivalent to 50 mg of tilmicosin base as tilmicosin phos- zolazepam base. phate. (b) Sponsors. See Nos. 026637, 051311, (b) Sponsor. See No. 058198 in and 054771 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (c) Related tolerances. See § 556.735 of (1) Amount. Expressed as milligrams of this chapter. the drug combination: (d) Special considerations. (1) Not for (i) Healthy dogs. An initial human use. Use of this antibiotic in intramuscular dosage of 3 to 4.5 milli- humans may prove fatal. Do not use in grams per pound (mg/lb) of body weight automatically powered syringes. for diagnostic purposes; 4.5 to 6 mg/lb (2) Federal law restricts this drug to of body weight for minor procedures of use by or on the order of a licensed vet- short duration such as repair of lacera- erinarian. tions and wounds, castrations, and (e) Conditions of use—(1) Cattle—(i) other procedures requiring mild to Amount. 10 to 20 milligrams per kilo- moderate analgesia. Supplemental grams (mg/kg) of body weight as a sin- doses when required should be less than gle subcutaneous injection. the initial dose and the total dose (ii) Indications for use. For the treat- given should not exceed 12 mg/lb of ment of bovine respiratory disease body weight. The maximum total safe (BRD) associated with Mannheimia dose is 13.6 mg/lb of body weight. haemolytica, Pasteurella multocida, and (ii) Healthy cats. An initial Histophilus somni. For the control of intramuscular dosage of 4.4 to 5.4 mg/lb respiratory disease in cattle at high of body weight is recommended for risk of developing BRD associated with such procedures as dentistry, treat- M. haemolytica. ment of abscesses, foreign body re- (iii) Limitations. Do not use in female moval, and related types of surgery; 4.8 dairy cattle 20 months of age or older. to 5.7 mg/lb of body weight for minor Use of this antibiotic in this class of procedures requiring mild to moderate cattle may cause milk residues. Do not analgesia, such as repair of lacerations, slaughter within 42 days of last treat- castrations, and other procedures of ment. short duration. Initial dosages of 6.5 to (2) Sheep—(i) Amount. 10 mg/kg body 7.2 mg/lb of body weight are rec- weight as a single subcutaneous injec- ommended for ovariohysterectomy and tion. onychectomy. When supplemental (ii) Indications for use. For the treat- doses are required, such individual sup- ment of ovine respiratory disease plemental doses should be given in in- (ORD) associated with Mannheimia (P.) crements that are less than the initial haemolytica. dose, and the total dose given (initial (iii) Limitations. Do not slaughter dose plus supplemental doses) should within 28 days of last treatment. not exceed the maximum allowable [67 FR 72367, Dec. 5, 2002, as amended at 75 safe dose of 32.7 mg/lb of body weight. FR 9334, Mar. 2, 2010; 81 FR 48703, July 26, (2) Indications for use. For restraint or 2016] for anesthesia combined with muscle relaxation in cats and in dogs for re- § 522.2473 Tiludronate. straint and minor procedures of short (a) Specifications. Each vial of powder duration (30 minutes average) requiring contains 500 milligrams (mg) mild to moderate analgesia. tiludronate disodium. Each milliliter

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of constituted solution contains 20 mg (A) 140 milligrams (mg) trenbolone tiludronate disodium. acetate (one implant consisting of 7 (b) Sponsor. See No. 061623 in pellets, each pellet containing 20 mg § 510.600(c) of this chapter. trenbolone acetate) per implant dose. (c) Conditions of use in horses—(1) (B) 140 mg trenbolone acetate (one Amount. Administer a single dose of 1 implant consisting of 8 pellets, each of mg per kilogram (0.45 mg/pound) of 7 pellets containing 20 milligrams body weight by intravenous infusion. trenbolone acetate, and 1 pellet con- (2) Indication for use. For the control taining 29 mg tylosin tartrate) per im- of clinical signs associated with navic- plant dose. ular syndrome. (ii) Indications for use. For improved (3) Limitations. Do not use in horses feed efficiency. intended for human consumption. Fed- (iii) Limitations. Implant eral law restricts this drug to use by or subcutaneously in ear only. Do not use on the order of a licensed veterinarian. in animals intended for subsequent [79 FR 18159, Apr. 1, 2014, as amended at 82 breeding or in dairy animals. Safety FR 21691, May 10, 2017] and effectiveness have not been established in veal calves. A withdrawal pe- § 522.2474 Tolazoline. riod has not been established for this (a) Specifications. Each milliliter of product in preruminating calves. Do solution contains tolazoline hydro- not use in calves to be processed for chloride equivalent to 100 milligrams veal. (mg) of base activity. (2) Heifers fed in confinement for (b) Sponsor. See No. 059399 in slaughter—(i) Amount. Use last 63 days § 510.600(c) of this chapter. prior to slaughter. (c) Conditions of use in horses—(1) (A) 200 mg trenbolone acetate (one Amount. Administer slowly by intra- implant consisting of 10 pellets, each venous injection 4 mg per kilogram of pellet containing 20 mg trenbolone ace- body weight or 1.8 mg per pound (4 mil- tate) per implant dose. liliters (mL) per 100 kilograms or 4 mL (B) 200 mg of trenbolone acetate (one per 220 pounds). implant consisting of 11 pellets, each of (2) Indications for use. For use in 10 pellets containing 20 mg of horses when it is desirable to reverse trenbolone acetate, and 1 pellet con- the effects of sedation and analgesia taining 29 mg of tylosin tartrate) per caused by xylazine. implant dose. (3) Limitations. Do not use in horses (ii) Indications for use. For increased intended for human consumption. Fed- rate of weight gain and improved feed eral law restricts this drug to use by or efficiency. on the order of a licensed veterinarian. (iii) Limitations. Implant [79 FR 16197, Mar. 25, 2014, as amended at 79 subcutaneously in ear only. Do not use FR 74020, Dec. 15, 2014; 80 FR 13230, Mar. 13, in animals intended for subsequent 2015] breeding or in dairy animals. Safety § 522.2476 Trenbolone acetate. and effectiveness have not been established in veal calves. A withdrawal pe- (a) Sponsors. See sponsors in riod has not been established for this § 510.600(c) of this chapter for use as in product in preruminating calves. Do paragraph (d) of this section. not use in calves to be processed for (1) No. 058198 for use as in paragraph veal. (c) of this section. (2) No. 000061 for use as in paragraphs [66 FR 47961, Sept. 17, 2001, as amended at 69 (c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), FR 70056, Dec. 2, 2004; 74 FR 61517, Nov. 25, (c)(2)(i)(A), (c)(2)(ii), and (c)(2)(iii) of 2009; 81 FR 48703, July 26, 2016] this section. (b) Related tolerances. See § 556.739 of § 522.2477 Trenbolone acetate and es- this chapter. tradiol. (c) Conditions of use—(1) Steers fed in (a) [Reserved] confinement for slaughter—(i) Amount. (b) Sponsors. See sponsors in Use 126 days prior to slaughter; should § 510.600(c) of this chapter for uses as in be reimplanted once after 63 days. paragraph (d) of this section.

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(1) No. 058198 for use as in paragraphs (ii) Indications for use. For increased (d)(1)(i)(A), (d)(1)(i)(B), (d)(1)(i)(C), rate of weight gain and improved feed (d)(1)(i)(D), (d)(1)(i)(E), (d)(1)(i)(F), efficiency. (d)(1)(ii), (d)(1)(iii), (d)(2), and (d)(3) of (iii) Limitations. Administer implant this section. subcutaneously in the ear only. Do not (2) No. 000061 for use as in paragraphs use in animals intended for subsequent (d)(1)(i)(A), (d)(1)(i)(C), (d)(1)(i)(D), breeding or in dairy animals. Safety (d)(1)(i)(G), (d)(1)(ii), (d)(1)(iii), and effectiveness have not been estab- (d)(2)(i)(A), (d)(2)(i)(C), (d)(2)(i)(D), lished in veal calves. A withdrawal pe- (d)(2)(ii), (d)(2)(iii), (d)(3)(i)(A), riod has not been established for this (d)(3)(ii), (d)(3)(iii), (d)(4), and (d)(5) of product in preruminating calves. Do this section. not use in calves to be processed for veal. (3) No. 054771 for use as in paragraphs (2) Heifers fed in confinement for (d)(1)(i)(A), (d)(1)(i)(D), (d)(1)(ii), slaughter—(i) Amount. (A) 140 mg (d)(1)(iii), (d)(3)(i)(A), (d)(3)(ii), and trenbolone acetate and 14 mg estradiol (d)(3)(iii) of this section. (one implant consisting of 7 pellets, (c) [Reserved] each pellet containing 20 mg (d) Conditions of use—(1) Steers fed in trenbolone acetate and 2 mg estradiol) confinement for slaughter—(i) Amount. per implant dose for use as in para- (A) 120 milligrams (mg) trenbolone ace- graph (d)(2)(ii)(A) of this section. tate and 24 mg estradiol (one implant (B) 140 mg trenbolone acetate and 14 consisting of 6 pellets, each pellet con- mg estradiol (one implant consisting of taining 20 mg trenbolone acetate and 4 8 pellets, each of 7 pellets containing 20 mg estradiol) per implant dose. mg trenbolone acetate and 2 mg estra- (B) 120 mg trenbolone acetate and 24 diol, and 1 pellet containing 29 mg mg estradiol (one implant consisting of tylosin tartrate) per implant dose for 7 pellets, each of 6 pellets containing 20 use as in paragraphs (d)(2)(ii)(A) of this mg trenbolone acetate and 4 mg estra- section. diol, and 1 pellet containing 29 mg (C) 80 mg trenbolone acetate and 8 tylosin tartrate) per implant dose. mg estradiol (one implant consisting of (C) 200 mg trenbolone acetate and 20 4 pellets, each pellet containing 20 mg mg estradiol (one implant consisting of trenbolone acetate and 2 mg estradiol) 10 pellets, each pellet containing 20 mg per implant dose for use as in para- trenbolone acetate and 2 mg estradiol) graph (d)(2)(ii)(B) of this section. per implant dose. (D) 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of (D) 80 mg trenbolone acetate and 16 10 pellets, each pellet containing 20 mg mg estradiol (one implant consisting of trenbolone acetate and 2 mg estradiol) 4 pellets, each pellet containing 20 mg per implant dose for use as in para- trenbolone acetate and 4 mg estradiol) graph (d)(2)(ii)(A) of this section. per implant dose. (E) 80 mg trenbolone acetate and 8 (E) 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of mg estradiol (one implant consisting of 5 pellets, each of 4 pellets containing 20 11 pellets, each of 10 pellets containing mg trenbolone acetate and 2 mg 20 mg trenbolone acetate and 2 mg es- estradiol, and 1 pellet containing 29 mg tradiol, and 1 pellet containing 29 mg tylosin tartrate) per implant dose for tylosin tartrate) per implant dose. use as in paragraph (d)(2)(ii)(B) of this (F) 80 mg trenbolone acetate and 16 section. mg estradiol (one implant consisting of (F) 200 mg trenbolone acetate and 20 5 pellets, each of 4 pellets containing 20 mg estradiol (one implant consisting of mg trenbolone acetate and 4 mg estra- 11 pellets, each of 10 pellets containing diol, and 1 pellet containing 29 mg 20 mg trenbolone acetate and 2 mg es- tylosin tartrate) per implant dose. tradiol, and 1 pellet containing 29 mg (G) 200 milligram (mg) trenbolone ac- tylosin tartrate) per implant dose. etate and 40 mg estradiol (one implant (ii) Indications for use. (A) For in- consisting of 10 pellets, each pellet con- creased rate of weight gain and im- taining 20 mg trenbolone acetate and 4 proved feed efficiency. mg estradiol) per implant dose. (B) For increased rate of weight gain.

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(iii) Limitations. Administer implant proved for repeated implantation (re- subcutaneously in the ear only. Do not implantation) with this or any other use in animals intended for subsequent cattle ear implant during the produc- breeding or in dairy animals. Safety tion phase(s) identified on labeling and effectiveness have not been estab- (beef steers and heifers fed in confine- lished in veal calves. A withdrawal pe- ment for slaughter) unless otherwise riod has not been established for this indicated on labeling because safety product in preruminating calves. Do and effectiveness have not been evalu- not use in calves to be processed for ated. veal. (5) Beef heifers fed in confinement for (3) Pasture cattle (slaughter, stocker, slaughter—(i) Amount. Each extended- and feeder steers and heifers)—(i) release implant contains 200 mg Amount. (A) 40 mg trenbolone acetate trenbolone acetate and 20 mg estradiol and 8 mg estradiol (one implant con- (one implant consisting of 6 coated and sisting of 2 pellets, each pellet con- 4 uncoated pellets, each pellet containing 20 mg trenbolone acetate and 4 taining 20 mg trenbolone acetate and 2 mg estradiol) per implant dose. mg estradiol). (B) 40 mg trenbolone acetate and 8 (ii) Indications for use. For increased mg estradiol (one implant consisting of rate of weight gain and improved feed 3 pellets, each of 2 pellets containing 20 efficiency for up to 200 days after im- mg trenbolone acetate and 4 mg estra- plantation. diol, and 1 pellet containing 29 mg (iii) Limitations. Administer implant tylosin tartrate) per implant dose. subcutaneously in the ear only. Do not (ii) Indications for use. For increased use in lactating dairy cows or in ani- rate of weight gain. mals intended for subsequent breeding. (iii) Limitations. Administer implant Use in these cattle may cause drug res- subcutaneously in the ear only. Do not idues in milk and/or in calves born to use in animals intended for subsequent these cows. Do not use in calves to be breeding or in dairy animals. Safety processed for veal. A withdrawal period and effectiveness have not been estab- has not been established for this prod- lished in veal calves. A withdrawal pe- uct in pre-ruminating calves. Effective- riod has not been established for this ness and animal safety in veal calves product in preruminating calves. Do have not been established. Not ap- not use in calves to be processed for proved for repeated implantation (reveal. implantation) with this or any other (4) Beef steers and heifers fed in con- cattle ear implant during the produc- finement for slaughter—(i) Amount. Each tion phase(s) identified on labeling extended- and delayed-release implant (beef heifers fed in confinement for contains 200 mg trenbolone acetate and slaughter) unless otherwise indicated 20 mg estradiol (one implant consisting on labeling because safety and effec- of 10 pellets, each pellet containing 20 tiveness have not been evaluated. mg trenbolone acetate and 2 mg estradiol) per implant dose. [60 FR 4376, Jan. 23, 1995] (ii) Indications for use. For increased EDITORIAL NOTE: For FEDERAL REGISTER ci- rate of weight gain and improved feed tations affecting § 522.2477, see the List of efficiency during 70 to 200 days after CFR Sections Affected, which appears in the implantation. Finding Aids section of the printed volume (iii) Limitations. Administer implant and at www.fdsys.gov. subcutaneously in the ear only. Do not use in lactating dairy cows or in ani- § 522.2478 Trenbolone acetate and estradiol benzoate. mals intended for subsequent breeding. Use in these cattle may cause drug res- (a) Specifications—(1) Each implant idues in milk and/or in calves born to consists of: these cows. Do not use in calves to be (i) 8 pellets, each pellet containing 25 processed for veal. A withdrawal period milligrams (mg) trenbolone acetate has not been established for this prod- and 3.5 mg estradiol benzoate. uct in pre-ruminating calves. Effective- (ii) 4 pellets, each pellet containing ness and animal safety in veal calves 25 mg trenbolone acetate and 3.5 mg es- have not been established. Not ap- tradiol benzoate.

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(2) Each extended release implant (2) Heifers fed in confinement for consists of: slaughter—(i) For an implant as de- (i) 8 pellets with a porous polymer scribed in paragraph (a)(1)(i) of this film coating, each pellet containing 25 section: mg trenbolone acetate and 3.5 mg es- (A) Amount. 200 mg trenbolone ace- tradiol benzoate. tate and 28 mg estradiol benzoate. (ii) 6 pellets with a porous polymer (B) Indications for use. For increased film coating, each pellet containing 25 rate of weight gain. mg trenbolone acetate and 3.5 mg es- (C) Limitations. Implant tradiol benzoate. subcutaneously in ear only. Not for use (b) Sponsor. See No. 054771 in in dairy or beef replacement heifers. § 510.600(c) of this chapter. Safety and effectiveness have not been (c) Related tolerances. See §§ 556.240 established in veal calves. A with- and 556.739 of this chapter. drawal period has not been established (d) Conditions of use—(1) Steers fed in for this product in preruminating confinement for slaughter. (i) For an im- calves. Do not use in calves to be proc- plant as described in paragraph (a)(1)(i) essed for veal. of this section: (ii) For an implant as described in (A) Amount. 200 mg trenbolone ace- paragraph (a)(1)(ii) of this section: tate and 28 mg estradiol benzoate. (A) Amount. 100 mg trenbolone acetate and 14 mg estradiol benzoate. (B) Indications for use. For increased (B) Indications for use. For increased rate of weight gain and improved feed rate of weight gain and improved feed efficiency. efficiency. (C) Limitations. Implant (C) Limitations. Implant subcutaneously in ear only. Safety and subcutaneously in ear only. Not for use effectiveness have not been established in dairy or beef replacement heifers. in veal calves. A withdrawal period has Safety and effectiveness have not been not been established for this product in established in veal calves. A with- preruminating calves. Do not use in drawal period has not been established calves to be processed for veal. for this product in preruminating (ii) For an implant as described in calves. Do not use in calves to be proc- paragraph (a)(1)(ii) of this section: essed for veal. (A) Amount. 100 mg trenbolone ace- (iii) For an implant as described in tate and 14 mg estradiol benzoate. paragraph (a)(2)(i) of this section: (B) Indications for use. For increased (A) Amount. 200 mg trenbolone ace- rate of weight gain. tate and 28 mg estradiol benzoate in an (C) Limitations. Implant extended release implant. subcutaneously in ear only. Safety and (B) Indications for use. For increased effectiveness have not been established rate of weight gain and improved feed in veal calves. A withdrawal period has efficiency for up to 200 days. not been established for this product in (C) Limitations. Implant preruminating calves. Do not use in subcutaneously in ear only. Not for use calves to be processed for veal. in dairy or beef replacement heifers. (iii) For an implant as described in Safety and effectiveness have not been paragraph (a)(2)(i) of this section: established in veal calves. A with- (A) Amount. 200 mg trenbolone ace- drawal period has not been established tate and 28 mg estradiol benzoate in an for this product in preruminating extended release implant. calves. Do not use in calves to be proc- (B) Indications for use. For increased essed for veal. rate of weight gain and improved feed (3) Pasture steers and heifers (slaugh- efficiency for up to 200 days. ter, stocker, and feeder)—(i) For an im- (C) Limitations. Implant plant as described in paragraph subcutaneously in ear only. Safety and (a)(2)(ii) of this section: effectiveness have not been established (A) Amount. 150 mg trenbolone ace- in veal calves. A withdrawal period has tate and 21 mg estradiol benzoate in an not been established for this product in extended release implant. preruminating calves. Do not use in (B) Indications for use. For increased calves to be processed for veal. rate of weight gain for up to 200 days.

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(C) Limitations. Implant (2) Horses—(i) Amount—(A) subcutaneously in ear only. Not for use Intramuscular or subcutaneous. Admin- in dairy or beef replacement heifers. ister 0.01 to 0.02 mg/lb of body weight as Safety and effectiveness have not been a single injection. Usual dose is 12 to 20 established in veal calves. A with- mg. drawal period has not been established (B) Intra-articular and intrasynovial. for this product in preruminating Administer 6 to 18 mg as a single injec- calves. Do not use in calves to be proc- tion, depending on the size of the joint essed for veal. and severity of symptoms. After 3 or 4 (ii) [Reserved] days, repeat dosage if indicated. If ini- [67 FR 78972, Dec. 27, 2002, as amended at 69 tial results are inadequate or too tran- FR 67818, Nov. 22, 2004; 79 FR 16197, Mar. 25, sient, dosage may be increased, not to 2014; 79 FR 64116, Oct. 28, 2014] exceed 18 mg. (ii) Indications for use. For the treat- § 522.2483 Triamcinolone. ment of inflammation and related dis- (a) Specifications. Each milliliter of orders. suspension contains 2 or 6 milligrams (iii) Limitations. Do not use in horses (mg) triamcinolone acetonide. intended for human consumption. Fed- (b) Sponsors. See Nos. 000010 and eral law restricts this drug to use by or 054628 in § 510.600(c) of this chapter. on the order of a licensed veterinarian. (c) Conditions of use—(1) Dogs and cats—(i) Amount—(A) Intramuscular or [75 FR 10167, Mar. 5, 2010, as amended at 78 subcutaneous. For inflammatory, ar- FR 21060, Apr. 9, 2013; 80 FR 34279, June 16, thritic, or allergic disorders, admin- 2015] ister 0.05 to 0.1 mg per pound (/lb) of body weight as a single injection. For § 522.2582 Triflupromazine. dermatologic disorders, administer 0.1 (a) Specifications. Each milliliter of mg per pound (/lb) of body weight as a solution contains 20 milligrams (mg) of single injection. If symptoms recur, the triflupromazine hydrochloride. dose may be repeated, or oral (b) Sponsor. See No. 054771 in corticosteroid therapy may be insti- § 510.600(c) of this chapter. tuted. (c) Conditions of use—(1) Amount—(i) (B) Intralesional. Administer 1.2 to 1.8 Dogs. Administer by intravenous injec- mg, divided in several injections tion at a dosage of 0.5 to 1 mg per around the lesion, spaced 0.5 to 2.5 cen- pound of body weight daily, or by timeters apart, depending on lesion intramuscular injection at a dosage of size. At any one site, the dose injected 1 to 2 mg per pound of body weight should not exceed 0.6 mg. and should be daily. well into the cutis to prevent rupture (ii) Cats. Administer by of the epidermis. When treating animals with multiple lesions, do not ex- intramuscular injection at a dosage of ceed a total dose of 6 mg. 2 to 4 mg per pound of body weight (C) Intra-articular and intrasynovial. daily. Administer 1 to 3 mg as a single injec- (iii) Horses. Administer by intra- tion, depending on the size of the joint venous or intramuscular injection at a and severity of symptoms. After 3 or 4 dosage of 10 to 15 mg per 100 pounds of days, repeat dosage if indicated. If ini- body weight daily to a maximum dose tial results are inadequate or too tran- of 100 mg. sient, dosage may be increased, not to (2) Indications for use. For use in dogs, exceed 3 mg. cats, and horses to relieve anxiety and (ii) Indications for use. For the treat- to help control psychomotor over- ment of inflammation and related dis- activity as well as to increase the tol- orders, and the management and treat- erance of animals to pain and pruritus. ment of acute arthritis and allergic The drug is indicated in various office and dermatologic disorders. and clinical procedures which require (iii) Limitations. Federal law restricts the aid of a tranquilizer, antiemetic, or this drug to use by or on the order of a preanesthetic. licensed veterinarian.

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(3) Limitations. Do not use in horses § 522.2615 Tripelennamine. intended for human consumption. Fed- (a) Specifications. Each milliliter of eral law restricts this drug to use by or solution contains 20 milligrams (mg) of on the order of a licensed veterinarian. tripelennamine hydrochloride. [79 FR 16197, Mar. 25, 2014] (b) Sponsors. See Nos. 016592 and 051031 in § 510.600(c) of this chapter. § 522.2610 Trimethoprim and sulfa- (c) Related tolerances. See § 556.741 of diazine. this chapter. (a) Specifications. Each milliliter (d) Conditions of use—(1) Dogs and (mL) contains: cats—(i) Amount. Administer 0.5 mg per (1) 40 milligrams (mg) trimethoprim pound of body weight by intramuscular suspended in a solution containing 200 injection. mg sulfadiazine; or (ii) Indications for use. For use in (2) 80 mg trimethoprim suspended in treating conditions in which antihis- a solution containing 400 mg sulfa- taminic therapy may be expected to diazine (as the sodium salt). lead to alleviation of some signs of dis- (b) Sponsors. See Nos. 000061 and ease. 054771 in § 510.600(c) of this chapter. (iii) Limitations. Federal law restricts (c) Conditions of use—(1) Dogs—(i) this drug to use by or on the order of a Amount. 1 mL of the product described licensed veterinarian. in paragraph (a)(1) of this section (40 (2) Horses—(i) Amount. Administer 0.5 mg trimethoprim and 200 mg sulfa- mg per pound of body weight by diazine) per 20 pounds (9 kilograms) of intramuscular injection. body weight per day by subcutaneous (ii) Indications for use. For use in injection. treating conditions in which antihis- (ii) Indications for use. For the treat- taminic therapy may be expected to ment of acute urinary tract infections, lead to alleviation of some signs of dis- acute bacterial complications of disease. temper, acute respiratory tract infec- (iii) Limitations. Do not use in horses tions, acute alimentary tract infec- intended for human consumption. Fed- tions, and acute septicemia due to eral law restricts this drug to use by or Streptococcus zooepidemicus. on the order of a licensed veterinarian. (iii) Limitations. Federal law restricts (3) Cattle—(i) Amount. Administer 0.5 this drug to use by or on the order of a mg per pound of body weight by intra- licensed veterinarian. venous or intramuscular injection. (ii) Indications for use. For use in (2) Horses—(i) Amount. 2 mL of the treating conditions in which antihis- product described in paragraph (a)(2) of taminic therapy may be expected to this section (160 mg trimethoprim and lead to alleviation of some signs of dis- 800 mg sulfadiazine) per 100 pounds (45 ease. kilograms) of body weight per day by intravenous injection as single, daily (iii) Limitations. Treated cattle must dose for 5 to 7 days. The daily dose may not be slaughtered for food during also be halved and given morning and treatment and for 4 days following the evening. last treatment. Milk that has been taken during treatment and for 24 (ii) Indications for use. For use where hours (two milkings) after the last systemic antibacterial action against treatment must not be used for food. A sensitive organisms is required during withdrawal period has not been estab- treatment of acute strangles, res- lished for this product in piratory tract infections, acute uro- preruminating calves. Do not use in genital infections, and wound infec- calves to be processed for veal. Federal tions and abscesses. law restricts this drug to use by or on (iii) Limitations. Do not use in horses the order of a licensed veterinarian. intended for human consumption. Fed- eral law restricts this drug to use by or [51 FR 44450, Dec. 10, 1986, as amended at 61 on the order of a licensed veterinarian. FR 29480, June 11, 1996; 62 FR 4164, Jan. 29, 1997; 78 FR 17597, Mar. 22, 2013; 79 FR 16198, [71 FR 30803, May 31, 2006, as amended at 79 Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; 82 FR FR 16197, Mar. 25, 2014] 11508, Feb. 24, 2017]

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§ 522.2630 Tulathromycin. within 22 days from the last treatment. (a) Specifications. Each milliliter of Not for use in ruminating cattle. Fed- solution contains: eral law restricts this drug to use by or (1) 100 milligrams (mg) on the order of a licensed veterinarian. tulathromycin (2) Swine—(i) Amount. 2.5 mg/kg body (2) 25 mg tulathromycin weight as a single intramuscular injec- (b) Sponsor. See No. 054771 in tion in the neck. § 510.600(c) of this chapter for use as in (ii) Indications for use. For the treat- paragraph (d) of this section: ment of swine respiratory disease (1) Product described as in paragraph (SRD) associated with Actinobacillus (a)(1) of this section for use as in para- pleuropneumoniae, P. multocida, graphs (d)(1)(i), (d)(1)(ii), (d)(1)(iii)(A), Bordetella bronchiseptica, Haemophilus and (d)(2) of this section. parasuis, and Mycoplasma (2) Product described as in paragraph hyopneumoniae; and for the control of (a)(2) of this section for use as in para- SRD associated with A. graphs (d)(1)(i), (d)(1)(ii)(B), pleuropneumoniae, P. multocida, and M. (d)(1)(iii)(B), and (d)(2) of this section. hyopneumoniae in groups of pigs where (c) Related tolerances. See § 556.745 of SRD has been diagnosed. this chapter. (iii) Limitations. Swine intended for (d) Conditions of use—(1) Cattle—(i) human consumption must not be Amount. 2.5 mg per kilogram (/kg) body slaughtered within 5 days from the last weight as a single subcutaneous injec- treatment. Federal law restricts this tion in the neck. drug to use by or on the order of a li- (ii) Indications for use—(A) Beef and censed veterinarian. non-lactating dairy cattle. For the treat- [70 FR 39918, July 12, 2005, as amended at 71 ment of bovine respiratory disease FR 57416, Sept. 29, 2006; 72 FR 54540, Sept. 26, (BRD) associated with Mannheimia 2007; 73 FR 6018, Feb. 1, 2008; 73 FR 58872, Oct. haemolytica, Pasteurella multocida, 8, 2008; 74 FR 53165, Oct. 16, 2009; 78 FR 63872, Histophilus somni, and Mycoplasma bovis. Oct. 25, 2013; 79 FR 74020, Dec. 15, 2014; 80 FR For the control of respiratory disease 13230, Mar. 13, 2015; 81 FR 67151, Sept. 30, 2016] in cattle at high risk of developing BRD associated with M. haemolytica, P. § 522.2640 Tylosin. multocida, H. somni, and M. bovis. For (a) Specifications. Each milliliter the treatment of infectious bovine (mL) of solution contains 50 or 200 mil- keratoconjunctivitis (IBK) associated ligrams (mg) of tylosin activity (as with Moraxella bovis. For the treatment tylosin base). of bovine foot rot (interdigital (b) Sponsors. See sponsors in necrobacillosis) associated with § 510.600(c) of this chapter as follows: Fusobacterium necrophorum and (1) No. 000986 for use of 50- or 200-mg/ Porphyromonas levii. mL solutions as in paragraph (e) of this (B) Suckling calves, dairy calves, and section. veal calves. For the treatment of bovine (2) Nos. 000010 and 061623 for use of a respiratory disease (BRD) associated 200-mg/mL solution as in paragraphs with Mannheimia haemolytica, (e)(1) and (2) of this section. Pasteurella multocida, Histophilus somni, (c) Related tolerances. See § 556.740 of and Mycoplasma bovis. this chapter. (iii) Limitations. (A) Cattle intended (d) Special considerations. Labeling for human consumption must not be must bear the warning statements: slaughtered within 18 days from the ‘‘Do not administer to horses or other last treatment. This drug is not ap- equines. Injection of tylosin in equines proved for use in female dairy cattle 20 has been fatal.’’ months of age or older, including dry (e) Conditions of use—(1) Beef cattle dairy cows. Use in these cattle may and nonlactating dairy cattle—(i) cause drug residues in milk and/or in Amount. Administer 8 mg per pound calves born to these cows. Federal law (mg/lb) of body weight by restricts this drug to use by or on the intramuscular injection once daily for order of a licensed veterinarian. not more than 5 consecutive days. Con- (B) Calves intended for human continue treatment 24 hours after symp- sumption must not be slaughtered toms disappear.

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(ii) Indications for use. Treatment of (ii) Indications for use—(A) Dogs. bovine respiratory complex (shipping Treatment of upper respiratory infec- fever, pneumonia) usually associated tions such as bronchitis, with Pasteurella multocida and tracheobronchitis, tracheitis, laryn- Arcanobacterium pyogenes; foot rot (ne- gitis, tonsillitis, and pneumonia caused crotic pododermatitis) and calf diph- by Staphylococci spp., hemolytic theria caused by Fusobacterium Streptococci spp., and Pasteurella necrophorum and metritis caused by A. multocida. pyogenes. (B) Cats. Treatment of upper res- (iii) Limitations. Do not inject more piratory infections when caused by than 10 mL per site. Use a 50-mg/mL so- Staphylococci spp. and hemolytic lution for calves weighing less than 200 Streptococci spp. and for feline pneumo- pounds. Cattle intended for human con- nitis when caused by tylosin-suscep- sumption must not be slaughtered tible organisms. within 21 days of the last use of this (iii) Limitations. Federal law restricts drug product. This drug product is not this drug to use by or on the order of a approved for use in female dairy cattle licensed veterinarian. 20 months of age or older, including dry [81 FR 67151, Sept. 30, 2016] dairy cows. Use in these cattle may cause drug residues in milk and/or in § 522.2662 Xylazine. calves born to these cows. This product (a) Specifications. Each milliliter is not approved for use in calves in- (mL) of solution contains xylazine hy- tended to be processed for veal. A with- drochloride equivalent to: drawal period has not been established (1) 20 milligrams (mg) xylazine. in preruminating calves. (2) 100 mg xylazine. (2) Swine—(i) Amount. Administer 4 (3) 300 mg xylazine. mg/lb of body weight by intramuscular (b) Sponsors. See sponsors in injection twice daily for not more than § 510.600(c) of this chapter for uses as in 3 consecutive days. Continue treatment paragraph (d) of this section. 24 hours after symptoms disappear. If (1) No. 054628 for use of product de- tylosin medicated drinking water is scribed in paragraph (a)(2) of this sec- used as a followup treatment for swine tion as in paragraph (d)(2) of this sec- dysentery, the animal should there- tion. after receive feed containing 40 to 100 (2) Nos. 000010 and 061623 for use of grams of tylosin per ton for 2 weeks to product described in paragraph (a)(2) of assure depletion of tissue residues. this section as in paragraphs (d)(2), (ii) Indications for use. Treatment of (d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of swine arthritis caused by Mycoplasma this section. hyosynoviae; swine pneumonia caused (3) Nos. 000859 and 061651 for use of by Pasteurella spp.; swine erysipelas product described in paragraph (a)(1) of caused by Erysipelothrix rhusiopathiae; this section as in paragraph (d)(1); and swine dysentery associated with product described in paragraph (a)(2) of Treponema hyodysenteriae when fol- this section as in paragraphs (d)(2), lowed by appropriate medication in the (d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of drinking water and/or feed. this section. (iii) Limitations. Do not inject more (4) No. 059399 for use of product de- than 5 mL per site. Adverse reactions, scribed in paragraph (a)(1) of this sec- including shock and death may result tion as in paragraph (d)(1) of this sec- from overdosage in baby pigs. It is rection; product described in paragraph ommended that tylosin 50-mg/mL in- (a)(2) of this section as in paragraphs jection be used in pigs weighing less (d)(2), (d)(3)(i), (d)(3)(ii)(A), and than 25 lbs. Swine intended for human (d)(3)(iii) of this section; and product consumption must not be slaughtered described in paragraph (a)(3) of this within 14 days of the last use of this section as in paragraphs (d)(3)(i), drug product. (d)(3)(ii)(B), and (d)(3)(iii) of this sec- (3) Dogs and cats—(i) Amount. Admin- tion. ister 3 to 5 mg/lb of body weight by (c) Special considerations. Federal law intramuscular injection at 12- to 24- restricts this drug to use by or on the hour intervals. order of a licensed veterinarian.

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(d) Conditions of use—(1) Dogs and (b) Sponsors. See sponsors in cats—(i) Amount. 0.5 mg/pound (lb) in- § 510.600(c) of this chapter for use as in travenously or 1.0 mg/lb paragraph (c) of this section. subcutaneously. (1) No. 059399 for use of in 2 mg/mL (ii) Indications for use. To produce se- solution as in paragraph (c)(1) of this dation, as an analgesic, and as a section. preanesthetic to local or general anes- (2) No. 053923 for use of in 5 mg/mL thesia. solution as in paragraph (c)(2) of this (2) Horses—(i) Amount. 0.5 mg/lb intra- section. venously or 1.0 mg/lb intramuscularly. (c) Conditions of use—(1) Dogs—(i) (ii) Indications for use. To produce se- Amount. Administer 0.05 mg per pound dation, as an analgesic, and as a (0.11 mg per kilogram) of body weight preanesthetic to local or general anes- by intravenous injection. thesia. (ii) Indications for use. To reverse the (iii) Limitations. Do not use in horses effects of xylazine in dogs. (iii) Not for use in food- intended for human consumption. Limitations. producing animals. Federal law re- (3) Elk and deer—(i) Amount. Admin- stricts this drug to use by or on the ister intramuscularly, by hand syringe, order of a licensed veterinarian. or by syringe dart, in the heavy mus- (2) Deer and elk—(i) Amount. Admin- cles of the croup or shoulder as follows: ister 0.2 to 0.3 mg per kilogram of body (A) Elk (Cervus canadensis): 0.25 to 0.5 weight by intravenous injection. mg/lb. (ii) Indications for use. A s an antago- (B) Mule deer (Odocoileus hemionus), nist to xylazine sedation in free rang- sika deer (Cervus nippon), and white- ing or confined members of the family tailed deer (Odocoileus virginianus): 1 to Cervidae (deer and elk). 2 mg/lb. (iii) Limitations. Do not use in domes- (C) Fallow deer (Dama dama): 2 to 4 tic food-producing animals. Do not use mg/lb. for 30 days before or during hunting (ii) Indications for use. (A) To produce season. Federal law restricts this drug sedation, as an analgesic, and as a to use by or on the order of a licensed preanesthetic to local anesthesia. veterinarian. (B) To produce sedation, accom- [79 FR 74020, Dec. 15, 2014, as amended at 80 panied by a shorter period of analgesia. FR 13230, Mar. 13, 2015] May be used to calm and facilitate handling of fractious animals for diag- § 522.2680 Zeranol. nostic procedures, for minor surgical (a) Specifications. Each pellet con- procedures, for therapeutic medication tains 12, 18, or 20 milligrams (mg) for sedation and relief of pain following zeranol. injury or surgery, and as a (b) Sponsor. See 000061 in § 510.600(c) of preanesthetic to local anesthetic. At this chapter. the recommended dosages, can be used (c) Related tolerances. See § 556.760 of in conjunction with local anesthetics, this chapter. such as procaine or lidocaine. (d) Conditions of use—(1) Beef cattle— (iii) Limitations. Do not use in domes- (i) Amount. 36 mg zeranol (one implant tic food-producing animals. Do not use consisting of 3 pellets, each pellet con- in Cervidae less than 15 days before or taining 12 mg zeranol) per implant during the hunting season. dose. [68 FR 26206, May 15, 2003, as amended at 75 (ii) Indications for use—(A) For in- FR 10167, Mar. 5, 2010, 78 FR 21060, Apr. 9, creased rate of weight gain and im- 2013; 79 FR 16198, Mar. 25, 2014; 79 FR 21127, proved feed conversion in weaned beef Apr. 15, 2014; 79 FR 74020, Dec. 15, 2014; 80 FR calves, growing beef cattle, feedlot 13230, Mar. 13, 2015] steers, and feedlot heifers. (B) For increased rate of weight gain § 522.2670 Yohimbine. in suckling calves. (a) Specifications. Each milliliter (iii) Limitations. Implant (mL) of solution contains 2 or 5 milli- subcutaneously in ear only. Do not use grams (mg) of yohimbine (as hydro- in bulls intended for reproduction or in chloride). dairy animals. Do not use before 1

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month of age or after weaning in heif- preruminating calves. Do not use in ers intended for reproduction. Safety calves to be processed for veal. and effectiveness have not been estab- [59 FR 19639, Apr. 25, 1994; 60 FR 26360, May lished in veal calves. A withdrawal pe- 17, 1995, as amended at 62 FR 61625, Nov. 19, riod has not been established for this 1997; 64 FR 46840, Aug. 27, 1999; 67 FR 6867, product in preruminating calves. Do Feb. 14, 2002; 70 FR 6764, Feb. 9, 2005] not use in calves to be processed for § 522.2690 Zinc gluconate. veal. (2) Feedlot lambs—(i) Amount. 12 mg (a) Specifications. Each milliliter of zeranol (one implant consisting of 1 solution contains 13.1 milligrams zinc pellet containing 12 mg zeranol) per as zinc gluconate neutralized to pH 7.0 with L-arginine. implant dose. (b) Sponsor. See No. 076175 in (ii) Indications for use. For increased § 510.600(c) of this chapter. rate of weight gain and improved feed (c) Conditions of use in dogs—(1) conversion. Amount. The volume injected into each (iii) Limitations. Implant testicle is based on testicular width as subcutaneously in ear only. Do not use determined by measuring each testicle in breeding animals. Do not implant at its widest point using a metric scale animals within 40 days of slaughter. (millimeter) caliper. Safety and effectiveness have not been (2) Indications for use. Intratesticular established in veal calves. A with- injection for chemical sterilization of drawal period has not been established 3- to 10-month-old male dogs. for this product in preruminating (3) Limitations. Federal law restricts calves. Do not use in calves to be proc- this drug to use by or on the order of a essed for veal. licensed veterinarian. (3) Steers fed in confinement for slaugh- [68 FR 26995, May 19, 2003, as amended at 76 ter—(i) Amount. 72 mg zeranol (one im- FR 79064, Dec. 21, 2011] plant consisting of 6 pellets, each pellet containing 12 mg zeranol) per im- PART 524—OPHTHALMIC AND TOP- plant dose. ICAL DOSAGE FORM NEW ANI- (ii) Indications for use. For increased MAL DRUGS rate of weight gain and improved feed efficiency. Sec. (iii) Limitations. Implant 524.86 Amitraz. 524.154 Bacitracin, neomycin, and poly- subcutaneously in ear only. Safety and myxin B ophthalmic ointment. effectiveness have not been established 524.155 Bacitracin, neomycin, polymyxin B, in veal calves. A withdrawal period has and hydrocortisone ophthalmic oint- not been established for this product in ment. preruminating calves. Do not use in 524.390 Chloramphenicol ophthalmic oint- calves to be processed for veal. ment. 524.402 Chlorhexidine. (4) Pasture cattle (slaughter, stocker, 524.450 Clotrimazole. feeder steers, and heifers)—(i) Amount. 524.463 Copper naphthenate. 138 mg zeranol (one implant consisting 524.575 Cyclosporine ophthalmic ointment. of 7 pellets, each of 6 pellets containing 524.590 Diclofenac. 524.660 Dimethyl sulfoxide. 20 mg zeranol and a seventh pellet con- 524.770 Doramectin. taining 18 mg zeranol) per implant 524.775 Emodepside and praziquantel. dose. 524.802 Enrofloxacin and silver sulfadiazine (ii) Indications for use. For increased otic emulsion. rate of weight gain. 524.814 Eprinomectin. 524.900 Famphur. (iii) Limitations. Implant 524.920 Fenthion. subcutaneously in ear only. Safety and 524.916 Fentanyl. effectiveness have not been established 524.955 Florfenicol, terbinafine, and in veal calves. A withdrawal period has betamethasone acetate otic gel. not been established for this product in 524.957 Florfenicol, terbinafine, and mometasone otic solution. 524.960 Flumethasone, neomycin, and polymyxin B ophthalmic solution.

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524.970 Flunixin. 524.1484j Neomycin and prednisolone oph- 524.981 [Reserved] thalmic ointment. 524.981a Fluocinolone cream. 524.1484k Neomycin and prednisolone sus- 524.981b Fluocinolone solution. pension. 524.981c Fluocinolone and neomycin cream. 524.1580 Nitrofurazone topical dosage forms. 524.981d Fluocinolone and dimethyl sulf- 524.1580a Nitrofurazone ointment. oxide solution. 524.981e Fluocinolone and dimethyl sulf- 524.1580b Nitrofurazone soluble powder. oxide otic solution. 524.1580c Nitrofurazone and butacaine oint- 524.998 Fluralaner. ment. 524.1005 Furazolidone powder. 524.1600 Nystatin ophthalmic and topical 524.1044 Gentamicin sophthalmic and top- dosage forms. ical dosage forms. 524.1600a Nystatin, neomycin, thiostrepton, 524.1044a Gentamicin ophthalmic solution. and triamcinolone ointment. 524.1044b Gentamicin and betamethasone 524.1600b Nystatin, neomycin, thiostrepton, otic solution. and triamcinolone ophthalmic ointment 524.1044c Gentamicin ophthalmic ointment. 524.1610 Orbifloxacin, mometasone furoate 524.1044d Gentamicin and betamethasone monohydrate, and posaconazole suspen- ointment. sion. 524.1044e Gentamicin spray. 524.1662 Oxytetracycline ophthalmic and 524.1044f Gentamicinand betamethasone topical dosage forms. spray. 524.1662a Oxytetracycline and hydro- 524.1044g Gentamicin, betamethasone, and cortisone spray. clotrimazole ointment. 524.1044h Gentamicin, mometasone, and 524.1662b Oxytetracycline and polymyxin B clotrimazole otic suspension. ophthalmic ointment. 524.1044i Gentamicin and betamethasone 524.1742 N-(Mercaptomethyl) phthalimide S- ophthalmic solution. (O,O-dimethyl phosphorodithioate) emul- 524.1132 Hydrocortisone, miconazole, and sifiable liquid. gentamicin otic suspension. 524.1982 Proparacaine ophthalmic solution. 524.1140 Imidacloprid and ivermectin. 524.2098 Selamectin. 524.1146 Imidacloprid and moxidectin. 524.2101 Selenium disulfide suspension. 524.1193 Ivermectin topical solution. 524.2350 Tolnaftate cream. 524.1195 Ivermectin otic suspension. 524.2482 Triamcinolone spray. 524.1200 Kanamycin ophthalmic and topical 524.2483 Triamcinolone cream. dosage forms. 524.2620 Liquid crystalline trypsin, Peru 524.1200a Kanamycin ophthalmic ointment. 524.1200b Kanamycin ophthalmic solution. balsam, castor oil. 524.1204 Kanamycin, amphomycin, and hy- AUTHORITY: 21 U.S.C. 360b. drocortisone ointment. 524.1240 Levamisole. SOURCE: 40 FR 13873, Mar. 27, 1975, unless 524.1376 2-Mercaptobenzothiazole solution. otherwise noted. 524.1443 Miconazole. 524.1445 Miconazole, polymixin B, and pred- § 524.86 Amitraz. nisolone suspension. 524.1446 Milbemycin otic solution. (a) Specifications. Amitraz liquid con- 524.1450 Moxidectin. tains 19.9 percent amitraz in an organic 524.1465 Mupirocin. solvent. 524.1484 Neomycin ophthalmic and topical (b) Sponsor. See No. 054771 in dosage forms. § 510.600(c) of this chapter. 524.1484b Neomycin, isoflupredone, tetra- (c) Conditions of use—(1) Indications caine, and myristyl-gamma-picolinium powder. for use. For dogs for the treatment of 524.1484c Neomycin, isoflupredone, and tet- generalized demodicosis (Demodex racaine ointment. canis). 524.1484d Neomycin, hydrocortisone, and (2) Amount. One 10.6 milliliter bottle tetracaine otic ointment. per 2 gallons of warm water (250 parts 524.1484e Neomycin and polymyxin B oph- per million) for each treatment, for a thalmic solution. 524.1484f Neomycin, prednisolone, and tetra- total of 3 to 6 treatments, 14 days caine otic suspension. apart. 524.1484g Neomycin, thiabendazole, and (3) Limitations. Federal law restricts dexamethasone solution. this drug to use by or on the order of a 524.1484h Neomycin, penicillin, polymyxin licensed veterinarian. B, and hydrocortisone suspension. 524.1484i Neomycin and hydrocortisone oint- [47 FR 18589, Apr. 30, 1982, as amended at 79 ment. FR 10967, Feb. 27, 2014]

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§ 524.154 Bacitracin, neomycin, and (3) Limitations. Federal law restricts polymyxin B ophthalmic ointment. this drug to use by or on the order of a licensed veterinarian. (a) Specifications. Each gram of ointment contains: [57 FR 37333, Aug. 18, 1992, as amended at 61 (1) 500 units bacitracin, 3.5 milli- FR 8873, Mar. 6, 1996; 62 FR 61626, Nov. 19, grams (mg) neomycin sulfate (equiva- 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014] lent to 3.5 mg neomycin base), and 10,000 units polymyxin B sulfate; or § 524.390 Chloramphenicol ophthalmic (2) 400 units bacitracin zinc, 5 mg ne- ointment. omycin sulfate (equivalent to 3.5 mg (a) Specifications. Each gram contains neomycin base), and 10,000 units poly- 10 milligrams chloramphenicol. myxin B sulfate. (b) Sponsors. See Nos. 043264 and (b) Sponsors. See sponsor numbers in 054771 in § 510.600(c) of this chapter. § 510.600(c) of this chapter as follows: (c) Conditions of use in dogs and cats— (1) No. 054771 for use of product de- (1) Amount. Apply every 3 hours around scribed in paragraph (a)(1) as in para- the clock for 48 hours, after which graph (c) of this section. night instillations may be omitted. (2) Nos. 000061, 043264, and 059399 for (2) Indications for use. For treatment use of product described in paragraph of bacterial conjunctivitis caused by (a)(2) as in paragraph (c) of this sec- pathogens susceptible to chloramphen- tion. icol. (3) Limitations. Federal law restricts (c) Conditions of use in dogs and cats— this drug to use by or on the order of a (1) Amount. Apply a thin film over the licensed veterinarian. Federal law pro- cornea 3 or 4 times daily. hibits the use of this drug in food-pro- (2) Indications for use. Treatment of ducing animals. superficial bacterial infections of the eyelid and conjunctiva of dogs and cats [77 FR 4897, Feb. 1, 2012, as amended at 77 FR when due to susceptible organisms. 64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014] (3) Limitations. Federal law restricts § 524.402 Chlorhexidine. this drug to use by or on the order of a (a) Specifications. Each gram of oint- licensed veterinarian. ment contains 10 milligrams [57 FR 37333, Aug. 18, 1992, as amended at 61 chlorhexidine acetate. FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, (b) Sponsors. See Nos. 054771 and 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, 058829 in § 510.600(c) of this chapter. Feb. 27, 2014; 80 FR 61297, Oct. 13, 2015] (c) Conditions of use in dogs, cats, and horses—(1) Indications for use. For use § 524.155 Bacitracin, neomycin, poly- as a topical antiseptic ointment for myxin B, and hydrocortisone oph- surface wounds. thalmic ointment. (2) Limitations. Do not use in horses (a) Specifications. Each gram of oint- intended for human consumption. ment contains 400 units of bacitracin [72 FR 265, Jan. 4, 2007, as amended at 79 FR zinc, 5 milligrams (mg) of neomycin 10967, Feb. 27, 2014] sulfate (equivalent to 3.5 mg of neomycin sulfate), 10,000 units of polymyxin B § 524.450 Clotrimazole. sulfate, and10 mg of hydrocortisone. (a) Specifications. Each gram of cream (b) Sponsors. See Nos. 000061 and contains 10 milligrams of clotrimazole. 043264 in § 510.600(c) of this chapter. (b) Sponsors. See No. 000859 in (c) Conditions of use in dogs and cats— § 510.600(c) of this chapter. (1) Amount. Apply a thin film over the (c) Conditions of use—(1) Amount. cornea three or four times daily. Apply 1⁄4-inch ribbon of cream per (2) Indications for use. For treating square inch of lesion once daily for 2 to acute or chronic conjunctivitis caused 4 weeks. by susceptible organisms. (2) Indications of use. For the treatment of fungal infections of dogs and cats caused by Microsporum canis and Trichophyton mentagrophytes.

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(3) Limitations. Federal law restricts cream twice daily over the affected this drug to use by or on the order of a joint for up to 10 days and rub thor- licensed veterinarian. oughly into the hair covering the joint [40 FR 48128, July 18, 1980, as amended at 79 until it disappears. FR 10967, Feb. 27, 2014] (2) Indications for use in horses. For the control of pain and inflammation § 524.463 Copper naphthenate. associated with osteoarthritis in tar- (a) Amount. The drug is a 37.5 percent sal, carpal, metacarpophalangeal, solution of copper naphthenate. metatarsophalangeal, and proximal (b) Sponsors. See Nos. 017135, 054771, interphalangeal (hock, knee, fetlock and 058829 in § 510.600(c) of this chapter. and pastern) joints. (c) Conditions of use in horses—(1) (3) Limitations. Do not use in horses Amount. Apply daily to affected hooves intended for human consumption. Fed- until fully healed. eral law restricts this drug to use by or (2) Indications for use. As an aid in on the order of a licensed veterinarian. treating horses and ponies for thrush caused by organisms susceptible to [69 FR 40767, July 7, 2004, as amended at 74 FR 26782, June 4, 2009; 74 FR 47436, Sept. 16, copper naphthenate. 2009] (3) Limitations. Use on horses and ponies only. Avoid contact around § 524.660 Dimethyl sulfoxide. eyes. Do not contaminate feed. Do not use in horses intended for human con- (a) Specifications—(1) Each milliliter sumption. (mL) of solution contains 90 percent dimethyl sulfoxide and 10 percent water. [47 FR 4250, Jan. 29, 1982, as amended at 68 (2) Each milliliter (mL) of gel prod- FR 55825, Sept. 29, 2003; 71 FR 38074, July 5, uct contains 90 percent dimethyl sulf- 2006; 79 FR 10967, Feb. 27, 2014] oxide. § 524.575 Cyclosporine ophthalmic (b) Sponsor. See No. 054771 in ointment. § 510.600(c) of this chapter. (a) Specifications. Each gram of oint- (c) Conditions of use in horses and ment contains 2 milligrams of dogs—(1) Amount—(i) Horses. Apply cyclosporine. topically two to three times daily in an (b) Sponsor. See No. 000061 in amount not to exceed 100 mL per day. § 510.600(c) of this chapter. Total duration of therapy should not (c) Conditions of use—(1) Amount. exceed 30 days. Apply a 1⁄4-inch strip of ointment di- (ii) Dogs. Apply topically three to rectly on the cornea or into the con- four times daily in an amount not to junctival sac of the affected eye(s) exceed 20 mL per day. Total duration of every 12 hours. therapy should not exceed 14 days. (2) Indications for use. For manage- (2) Indications for use. To reduce acute ment of chronic keratoconjunctivitis swelling due to trauma. sicca (KCS) and chronic superficial (3) Limitations. Do not use in horses keratitis (CSK) in dogs. intended for human consumption. Fed- (3) Limitations. Federal law restricts eral law restricts this drug to use by or this drug to use by or on the order of a on the order of a licensed veterinarian. licensed veterinarian. [79 FR 10967, Feb. 27, 2014] [60 FR 48651, Sept. 20, 1995, as amended at 62 FR 48940, Sept. 18, 1997; 79 FR 10967, Feb. 27, § 524.770 Doramectin. 2014] (a) Specifications. Each milliliter § 524.590 Diclofenac. (mL) of solution contains 5 milligrams (a) Specifications. Each gram of cream (mg) doramectin. contains 10 milligrams diclofenac so- (b) Sponsor. See No. 054771 in dium. § 510.600(c) of this chapter. (b) Sponsor. See No. 000010 in (c) Related tolerances. See § 556.225 of § 510.600(c) of this chapter. this chapter. (c) Conditions of use in horses—(1) (d) Special considerations. See § 500.25 Amount. Apply a 5-inch (5″) ribbon of of this chapter.

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(e) Conditions of use in cattle—(1) § 524.775 Emodepside and Amount. Administer topically as a sin- praziquantel. gle dose 0.5 mg (1 mL) per kilogram (1 (a) Specifications. Each milliliter of mL per 22 pounds) body weight. solution contains 21.4 milligrams (mg) (2) Indications for use. For treatment emodepside and 85.7 mg praziquantel. and control of gastrointestinal (b) Sponsor. See No. 000859 in roundworms: Ostertagia ostertagi (adults § 510.600(c) of this chapter. and fourth-stage larvae), Ostertagia (c) Conditions of use in cats—(1) ostertagi (inhibited fourth-stage lar- Amount. The recommended minimum vae), Ostertagia lyrata (adults), dose is 1.36 mg/pound (lb) (3 mg/kilo- Haemonchus placei (adults and fourth- gram (kg)) emodepside and 5.45 mg/lb stage larvae), Trichostrongylus axei (12 mg/kg) praziquantel applied as a (adults and fourth-stage larvae), single topical dose. Trichostrongylus colubriformis (adults (2) Indications for use. For the treat- and fourth-stage larvae), Cooperia ment and control of hookworm infec- oncophora (adults and fourth-stage lar- tions caused by Ancylostoma tubaeforme vae), Cooperia punctata (adults and (adults, immature adults, and fourth fourth-stage larvae), Cooperia pectinata stage larvae), roundworm infections (adults), Cooperia surnabada (adults), caused by Toxocara cati (adults and Bunostomum phlebotomum (adults), fourth stage larvae), and tapeworm in- Oesophagostomum radiatum (adults and fections caused by Dipylidium caninum fourth-stage larvae), Trichuris spp. (adults) and Taenia taeniaeformis (adults); lungworms: Dictyocaulus (adults). viviparus (adults and fourth-stage lar- (3) Limitations. Federal law restricts vae); eyeworms: Thelazia gulosa this drug to use by or on the order of a (adults), Thelazia skrjabini (adults); licensed veterinarian. grubs: Hypoderma bovis and Hypoderma lineatum; sucking lice: Linognathus [72 FR 42291, Aug. 2, 2007] vituli, Haematopinus eurysternus, and Solenopotes capillatus; biting lice: § 524.802 Enrofloxacin and silver sulfa- Bovicola (Damalinia) bovis; mange diazine otic emulsion. mites: Chorioptes bovis and Sarcoptes (a) Specifications. Each milliliter con- scabiei; horn flies: Haematobia irritans; tains 5 milligrams (mg) enrofloxacin and to control infections and to protect and 10 mg silver sulfadiazine. from reinfection with Cooperia (b) Sponsor. See No. 000859 in oncophora, Dictyocaulus viviparus, § 510.600(c) of this chapter. Ostertagia ostertagi, and (c) Conditions of use—Dogs—(1) Oesophagostomum radiatum for 28 days; Amount. 5 to 10 drops for dogs weighing and with Cooperia punctata and 35 pounds (lb) or less and 10 to 15 drops Haemonchus placei for 35 days after for dogs weighing more than 35 lb; ap- treatment; and to control infestations plied twice daily for up to 14 days. and to protect from reinfestation with (2) Indications for use. For the treat- Linognathus vituli for 42 days and with ment of otitis externa in dogs. Bovicola (Damalinia) bovis for 77 days (3) Limitations. Federal law restricts after treatment. this drug to use by or on the order of a (3) Limitations. Do not slaughter cat- licensed veterinarian. Federal law pro- tle within 45 days of latest treatment. hibits the extralabel use of this drug in This product is not approved for use in food-producing animals. female dairy cattle 20 months of age or [65 FR 66620, Nov. 7, 2000, as amended at 79 older, including dry dairy cows. Use in FR 10967, Feb. 27, 2014] these cattle may cause drug residues in milk and/or in calves born to these § 524.814 Eprinomectin. cows. A withdrawal period has not been (a) Specifications. Each milliliter established for this product in (mL) contains 5 milligrams (mg) of preruminating calves. Do not use in eprinomectin. calves to be processed for veal. (b) Sponsor. See No. 050604 in [69 FR 48392, Aug. 10, 2004, as amended at 70 § 510.600(c) of this chapter. FR 43046, July 26, 2005; 79 FR 10967, Feb. 27, (c) Related tolerances. See § 556.227 of 2014] this chapter.

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(d) Special considerations. See § 500.25 (2) Indications for use in beef and non- of this chapter. lactating dairy cattle. For control of cat- (e) Conditions of use in cattle—(1) tle grubs and to reduce cattle lice in- Amount. Apply 5 mg (1 mL) per 10 kilo- festations. grams (kg) of body weight (500 (3) Limitations. Do not slaughter with- micrograms/kg) applied topically along in 35 days after treatment. Do not use backbone from withers to tailhead. on lactating dairy cows or dry dairy (2) Indications for use. For treatment cows within 21 days of freshening, and control of gastrointestinal calves less than 3 months old, animals roundworms (Haemonchus placei (adult stressed from castration, overexcite- and L4), Ostertagia ostertagi (adult and ment or dehorning, sick or convales- L4, including inhibited L4), cent animals. Animals may become de- Trichostrongylus axei (adult and L4), T. hydrated and under stress following colubriformis (adult and L4), T. shipment. Do not treat until they are longispicularis (adult), Cooperia in good condition. Brahman and Brah- oncophora (adult and L4), C. punctata man crossbreeds are less tolerant of (adult and L4), C. surnabada (adult and cholinesterase-inhibiting insecticides L4), Nematodirus helvetianus (adult and than other breeds. Do not treat Brah- L4), Bunostomum phlebotomum (adult man bulls. Swine should be eliminated and L4), Oesophagostomum radiatum from area where runoff occurs. (adult and L4), Strongyloides papillosus (adults), Trichuris spp. (adults)); [40 FR 13873, Mar. 27, 1975, as amended at 49 lungworms (Dictyocaulus viviparus, FR 34352, Aug. 30, 1984; 57 FR 7652, Mar. 4, adult and L4); cattle grubs (all para- 1992; 59 FR 28769, June 3, 1994; 62 FR 55161, Oct. 23, 1997; 62 FR 61626, Nov. 19, 1997; 69 FR sitic stages Hypoderma lineatum, H. 41427, July 9, 2004; 79 FR 10968, Feb. 27, 2014] bovis); lice (Damalinia bovis, Linognathus vituli, Haematopinus § 524.916 Fentanyl. eurysternus, Solenopotes capillatus); mange mites (Chorioptes bovis, Sarcoptes (a) Specifications. Each milliliter of scabiei); and horn flies (Haematobia solution contains 50 milligrams (mg) irritans). Controls and protects from re- fentanyl. infection of D. viviparus for 21 days (b) Sponsor. See No. 058198 in after treatment and H. irritans for 7 § 510.600(c) of this chapter. days after treatment. (c) Conditions of use—(1) Dogs—(i) (3) Limitations. A withdrawal period Amount. 1.2 mg/lb (2.7 mg/kg) applied has not been established for topically to the dorsal scapular area 2 preruminating calves. Do not use in to 4 hours prior to surgery. calves to be processed for veal. (ii) Indications for use. For the control of postoperative pain associated with [76 FR 72619, Nov. 25, 2011] surgical procedures in dogs. § 524.900 Famphur. (iii) Limitations. Fentanyl is a Class II controlled substance. Observe all (a) Specifications. The drug is in liquid ‘‘black-box warnings’’ on product label- form containing 13.2 percent famphur. ing. Federal law restricts this drug to (b) Sponsor. See Nos. 000061 and 051311 use by or on the order of a licensed vet- in § 510.600(c) of this chapter. erinarian. (c) Special considerations. Do not use (2) [Reserved] on animals simultaneously or within a few days before or after treatment with [77 FR 47512, Aug. 9, 2012, as amended at 79 or exposure to cholinesterase-inhib- FR 44433, July 24, 2013; 81 FR 48703, July 26, iting drugs, pesticides, or chemicals. 2016] (d) Related tolerances. See § 556.273 of this chapter. § 524.920 Fenthion. (e) Conditions of use—(1) Amount. (a) Specifications. (1) The drug is a liq- Apply 1 ounce per 200 pounds body uid containing: weight, not to exceed a total dosage of (i) 3 percent of fenthion; or 4 ounces, from the shoulder to the tail (ii) 20 percent fenthion. head as a single treatment. Apply as (2) The drug is a solution containing soon as possible after heel fly activity either 5.6 or 13.8 percent fenthion. Each ceases. concentration is available in 2 volumes

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which are contained in single-dose ap- placed on the backline of animals as plicators. follows: For animals weighing 150 to (b) Sponsor. See sponsors in 300 pounds, apply 4 milliliters (mL); for § 510.600(c) of this chapter: animals weighing 301 to 600 pounds, (1) No. 000859 for use of product de- apply 8 mL; for animals weighing 601 to scribed in paragraph (a)(1)(i) as in para- 900 pounds, apply 12 mL; for animals graph (d)(1) of this section. weighing 901 to 1,200 pounds, apply 16 (2) No. 000859 for use of product de- mL; and for animal weighing over 1,200 scribed in paragraph (a)(1)(ii) as in pounds, apply 20 mL. For most effec- paragraph (d)(2) of this section. tive results, cattle should be treated as (3) No. 000859 for use of products de- soon as possible after heel-fly activity scribed in paragraph (a)(2) as in para- ceases. A second application is required graph (d)(3) of this section. for animals heavily infested with lice (c) Related tolerances. See 40 CFR or for those which become reinfested. A 180.214. second application should be made no (d) Conditions of use—(1) Beef cattle sooner than 35 days after the first and nonlactating dairy cattle—(i) treatment. Amount. It is used at the rate of one- (ii) Indications for use. For control of half fluid ounce per 100 pounds of body cattle grubs and as an aid in control- weight applied topically on the ling lice on beef cattle and on dairy backline of the animal. Only one appli- cattle not of breeding age. cation per season should be made for (iii) Limitations. Do not use on ani- grub control and this will also provide mals simultaneously or within a few initial control of lice. A second appli- days before or after treatment with or cation for lice control may be made if exposure to cholinesterase-inhibiting animals become reinfested, but no drugs, pesticides, or chemicals. Host- sooner than 35 days after the first parasite reactions such as bloat, saliva- treatment. Proper timing of treatment tion, staggering and paralysis may is important for grub control; cattle sometimes occur when cattle are treat- should be treated as soon as possible ed while the common cattle grub after heel-fly activity ceases. (Hypoderma lineatum) is in the gullet, (ii) Indications for use. For the control or while the northern cattle grub (H. of grubs and lice in beef and nonlac- bovis) is in the area of the spinal cord. tating cattle. Cattle should be treated before these (iii) Limitations. Do not use on ani- stages of grub development. Consult mals simultaneously or within a few your veterinarian, extension livestock days before or after treatment with or specialist, or extension entomologist exposure to cholinesterase-inhibiting regarding the timing of treatment. If it drugs, pesticides, or chemicals. Cattle is impossible to determine the area should not be slaughtered within 35 from which the cattle came and/or days following a single treatment. If a exact stage of the grubs, it is rec- second application is made for lice con- ommended that the cattle receive only trol, cattle should not be slaughtered a maintenance ration of low-energy within 45 days of the second treatment. feed during the treatment period. This The drug must not be used within 28 lessens the likelihood of severe bloat days of freshening of dairy cattle. If which may occur in cattle on full feed freshening should occur within 28 days when the common grub is killed while after treatment, do not use milk as in the gullet. Do not treat dairy cattle human food for the balance of the 28- of breeding age; calves less than 3 day interval. Do not treat lactating months old; sick, convalescent, or se- dairy cattle; calves less than 3 months verely stressed livestock. Do not treat old; or sick, convalescent, or stressed cattle for 10 days before or after ship- livestock. Do not treat cattle for 10 ping, weaning, dehorning, or after ex- days before or after shipping, weaning, posure to contagious or infectious dis- or dehorning or after exposure to con- eases. Do not slaughter within 45 days tagious infectious diseases. of treatment. (2) Beef cattle and dairy cattle not of (3) Dogs—(i) Amount. Four to 8 milli- breeding age—(i) Amount. It is adminis- grams per kilogram of body weight. tered as a single, topical application Apply the contents of the proper size,

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single-dose tube directly to one spot on § 524.960 Flumethasone, neomycin, the dog’s skin. and polymyxin B ophthalmic solu- (ii) Indications for use. For flea con- tion. trol on dogs only. (a) Specifications. Each milliliter of (iii) Limitations. Federal law restricts ophthalmic preparation contains 0.10 this drug to use by or on the order of a milligram flumethasone, 5.0 milligrams licensed veterinarian. neomycin sulfate (3.5 milligrams neomycin base), and 10,000 units of poly- [79 FR 10968, Feb. 27, 2014] myxin B sulfate, with or without hydroxypropyl methylcellulose. § 524.955 Florfenicol, terbinafine, and (b) Sponsor. See No. 054771 in betamethasone acetate otic gel. § 510.600(c) of this chapter. (a) Specifications. Each milliliter of (c) Conditions of use—(1) Amount—(i) gel contains 10 milligrams (mg) Preparation containing hydroxypropyl florfenicol, 10 mg terbinafine, and 1 mg methylcellulose. Dogs: 1 to 2 drops per betamethasone acetate. eye, every 6 hours. (b) Sponsor. See No. 058198 in (ii) Preparation without hydroxyproply § 510.600(c) of this chapter. methylcellulose. Dogs and cats: 2 to 3 drops per eye, every 4 hours. (c) Conditions of use in dogs—(1) (2) Indications for use. Treatment of Amount. Administer one dose (1 tube) the inflammation, edema, and sec- per affected ear(s) and repeat adminis- ondary bacterial infections associated tration in 7 days. with topical ophthalmological condi- (2) Indications for use. For the treat- tions of the eye such as corneal inju- ment of otitis externa in dogs associ- ries, incipient pannus, superficial kera- ated with susceptible strains of bac- titis, conjunctivitis, acute teria (Staphylococcus pseudintermedius) nongranulomatous anterior uveitis, and yeast (Malassezia pachydermatis). keratoconjunctivitis, and blepharitis. (3) Limitations. Federal law restricts (3) Limitations. Federal law restricts this drug to use by or on the order of a this drug to use by or on the order of a licensed veterinarian. licensed veterinarian. [80 FR 13230, Mar. 13, 2015] [44 FR 16012, Mar. 16, 1979, as amended at 61 FR 5507, Feb. 13, 1996; 79 FR 10968, Feb. 27, § 524.957 Florfenicol, terbinafine, and 2013] mometasone otic solution. § 524.970 Flunixin. (a) Specifications. Each single-dose, (a) Specifications. Each milliliter of prefilled dropperette contains 1 milli- solution contains 50 milligrams (mg) liter (mL) of a solution containing 15 flunixin (equivalent to 83 mg flunixin milligrams (mg) florfenicol, 13.3 mg meglumine). terbinafine, and 2 mg mometasone (b) Sponsor. See No. 000061 in furoate. § 510.600(c) of this chapter. (b) Sponsor. See No. 000859 in (c) Related tolerances. See § 556.286 of § 510.600(c) of this chapter. this chapter. (c) Conditions of use in dogs—(1) (d) Conditions of use—(1) Amount. Amount. Administer one dropperette (1 Apply only once at a dose of 3.3 mg mL) per affected ear(s). flunixin per kg body weight (1.5 mg/lb; (2) Indications for use. For the treat- 3 mL per 100 lbs) topically in a narrow ment of otitis externa in dogs associ- strip along the dorsal midline from the withers to the tailhead. ated with susceptible strains of yeast (2) Indications for use. For the control (Malassezia pachydermatis) and bacteria of pyrexia associated with bovine res- (Staphylococcus pseudintermedius). piratory disease and the control of pain (3) Limitations. Federal law restricts associated with foot rot in steers, beef this drug to use by or on the order of a heifers, beef cows, beef bulls intended licensed veterinarian. for slaughter, and replacement dairy [80 FR 76387, Dec. 9, 2015] heifers under 20 months of age. (3) Limitations. Federal law restricts this drug to use by or on the order of a

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licensed veterinarian. Cattle must not (3) Federal law restricts this drug to be slaughtered for human consumption use by or on the order of a licensed vet- within 8 days of the last treatment. erinarian. Not for use in female dairy cattle 20 months of age or older, including dry [40 FR 13873, Mar. 27, 1975, as amended at 62 FR 40932, July 31, 1997; 79 FR 10969, Feb. 27, dairy cows; use in these cattle may 2014] cause drug residues in milk and/or in calves born to these cows or heifers. § 524.981c Fluocinolone and neomycin Not for use in suckling beef calves, cream. dairy calves, and veal calves. A withdrawal period has not been established (a) Specifications. The drug contains for this product in pre-ruminating 0.025 percent fluocinolone acetonide calves. and 0.5 percent neomycin sulfate (0.35 percent neomycin base). [83 FR 13635, Mar. 30, 2018] (b) Sponsor. See No. 099207 in § 510.600(c) of this chapter. § 524.981 [Reserved] (c) Conditions of use in dogs—(1) § 524.981a Fluocinolone cream. Amount—A small amount is applied to the affected area two or three times (a) Specifications. The drug contains daily. 0.025 percent fluocinolone acetonide. (b) Sponsor. See No. 099207 in (2) Indications for use—(i) Dogs. For § 510.600(c) of this chapter. the relief of pruritis and inflammation (c) Conditions of use in dogs—(1) associated with superficial acute and Amount—A small amount is applied to chronic dermatoses. It is used in the the affected area two or three times treatment of allergic and acute moist daily. dermatitis and nonspecific dermatoses. (2) Indications for use. For the relief of (ii) Dogs and cats. Used in the treat- pruritis and inflammation associated ment of wound infections. with certain superficial acute and (3) Federal law restricts this drug to chronic dermatoses. It is used in the use by or on the order of a licensed vet- treatment of allergic and acute moist erinarian. dermatitis and for the relief of super- [40 FR 13873, Mar. 27, 1975, as amended at 62 ficial inflammation caused by chemical FR 40932, July 31, 1997; 79 FR 10969, Feb. 27, burns and physical abrasions. 2014] (3) Federal law restricts this drug to use by or on the order of a licensed vet- § 524.981d Fluocinolone and dimethyl erinarian. sulfoxide solution. [40 FR 13873, Mar. 27, 1975, as amended at 62 (a) Specifications. Each milliliter of FR 40932, July 31, 1997; 79 FR 10968, Feb. 27, solution contains 0.01 percent 2014] fluocinolone acetonide and 20 percent dimethyl sulfoxide. § 524.981b Fluocinolone solution. (b) Sponsor. See No. 054771 in (a) Specifications. The drug contains § 510.600(c) of this chapter. 0.01 percent fluocinolone acetonide. (c) Conditions of use in dogs—(1) (b) Sponsor. See No. 099207 in Amount—Instill 1 to 2 milliliters into § 510.600(c) of this chapter. each anal sac following expression of (c) Conditions of use in dogs—(1) anal sac contents. Amount—A small amount of solution is (2) Indications for use. For the relief of applied to the affected area two or impaction commonly present in appar- three times daily. ently normal anal sacs, for the reversal (2) Indications for use—(i) Dogs. For of inflammatory changes associated the relief of pruritis and inflammation with abnormal anal sacs, and to coun- associated with otitis externa and cer- teract the offensive odor of anal sac se- tain superficial acute and chronic cretions. dermatoses. (3) Limitations. Federal law restricts (ii) Cats. For the relief of pruritis and this drug to use by or on the order of a inflammation associated with acute licensed veterinarian. otitis externa and certain superficial acute and chronic dermatoses. [79 FR 10969, Feb. 27, 2014]

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§ 524.981e Fluocinolone and dimethyl lb (40 mg/kg) body weight. May be ad- sulfoxide otic solution. ministered every 8 weeks in case of po- (a) Specifications. Each milliliter of tential exposure to D. variabilis ticks. solution contains 0.01 percent (ii) Indications for use. Kills adult fluocinolone acetonide and 60 percent fleas; for the treatment and prevention dimethyl sulfoxide. of flea infestations (C. felis) and the (b) Sponsor. See No. 054771 in treatment and control of I. scapularis § 510.600(c) of this chapter. (black-legged tick) infestations for 12 (c) Conditions of use in dogs—(1) weeks in cats and kittens 6 months of Amount—Instill 4 to 6 drops (0.2 milli- age and older, and weighing 2.6 lb or liter) twice daily into the ear canal for greater; for the treatment and control a maximum period of 14 days. The total of D. variabilis (American dog tick) in- dosage used should not exceed 17 milli- festations for 8 weeks in cats and kit- liters. tens 6 months of age and older, and (2) Indications for use. For the relief of weighing 2.6 lb or greater. pruritis and inflammation associated (iii) Limitations. Federal law restricts with acute and chronic otitis. this drug to use by or on the order of a (3) Limitations. Federal law restricts licensed veterinarian. this drug to use by or on the order of a [81 FR 67152, Sept. 30, 2016, as amended at 82 licensed veterinarian. FR 43485, Sept. 18, 2017] [79 FR 10969, Feb. 27, 2014] § 524.1005 Furazolidone powder. § 524.998 Fluralaner. (a) Specifications. The product con- (a) Specifications. Each milliliter of tains either 4 or 10 percent furazolidone solution contains 280 milligrams (mg) in inert dispersing agent and propel- fluralaner. lant. (b) Sponsor. See No. 000061 in (b) Sponsors. (1) See No. 051031 in § 510.600(c) of this chapter. § 510.600(c) of this chapter for use as in (c) Conditions of use—(1) Dogs—(i) paragraphs (c)(1), (c)(2)(i), (c)(2)(ii), and Amount. Administer topically as a sin- (c)(3) of this section. gle dose every 12 weeks according to (2) See No. 017135 for use of the 4 per- the label dosage schedule to provide a cent product as in paragraph (c)(2)(iv) minimum dose of 11.4 mg/lb (25 mg/kg) of this section. body weight. May be administered (c) Conditions of use—(1) Amount. Hold every 8 weeks in case of potential expo- container about 6 to 12 inches from the sure to ticks. Amblyomma americanum eye or affected area and apply only (ii) Indications for use. Kills adult enough powder to impart a light yellow fleas; for the treatment and prevention color. of flea infestations (Ctenocephalides (2) —(i) For felis) and the treatment and control of Indications of use Dogs. tick infestations (Ixodes scapularis treatment or prevention of bacterial (black-legged tick), Dermacentor infection of superficial wounds, abra- variabilis (American dog tick), and sions, lacerations, and pyogenic derma- Rhipicephalus sanguineus (brown dog titis. tick)) for 12 weeks in dogs and puppies (ii) Horses. For treatment or preven- 6 months of age and older, and weigh- tion of bacterial infection of superficial ing 4.4 lb or greater; for the treatment wounds, abrasions, lacerations, and fol- and control of A. americanum (lone star lowing firing (heat or electrocautery). tick) infestations for 8 weeks in dogs (iii) [Reserved] and puppies 6 months of age and older, (iv) Horses and ponies. For treatment and weighing 4.4 lb or greater. or prevention of bacterial infection of (iii) Limitations. Federal law restricts superficial wounds, abrasions, and lac- this drug to use by or on the order of a erations caused by Staphylococcus licensed veterinarian. aureus, Streptococcus spp. and Proteus (2) Cats—(i) Amount. Administer topi- spp. sensitive to furazolidone. cally as a single dose every 12 weeks (3) Limitations. For topical applica- according to the label dosage schedule tion in horses, ponies, and dogs: Clean to provide a minimum dose of 18.2 mg/ affected area thoroughly, apply drug

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once or twice daily, and repeat treat- eight drops of solution into the ear ment as required. Use only as rec- canal twice daily for 7 to 14 days. ommended by a veterinarian in treat- (ii) For the treatment of infected su- ment of puncture wounds, wounds re- perficial lesions caused by bacteria quiring surgical debridement or sutur- sensitive to gentamicin in dogs and ing, those of a chronic nature involving cats, apply a sufficient amount of the proud flesh, generalized and chronic in- drug to cover the treatment area twice fections of the skin, and those skin daily for 7 to 14 days. conditions associated with intense (2) Limitations. Federal law restricts itching. If redness, irritation, or swell- this drug to use by or on the order of a ing persists or increases, discontinue licensed veterinarian. use and consult a veterinarian. Do not use in horses intended for human con- [71 FR 13542, Mar. 16, 2006] sumption. § 524.1044c Gentamicin ophthalmic [45 FR 49543, July 25, 1980, as amended at 50 ointment. FR 30153, July 24, 1985; 56 FR 50653, Oct. 8, 1991; 57 FR 31314, July 15, 1992; 60 FR 55659, (a) Specifications. Each gram of oint- Nov. 2, 1995; 65 FR 41588, July 6, 2000; 79 FR ment contains gentamicin sulfate 10969, Feb. 27, 2014; 82 FR 11508, Feb. 24, 2017] equivalent to 3 milligrams of gentamicin. § 524.1044 Gentamicin ophthalmic and (b) Sponsors. See Nos. 000061 and topical dosage forms. 043264 in § 510.600(c) of this chapter. § 524.1044a Gentamicin ophthalmic so- (c) Conditions of use in dogs and cats— lution. (1) Amount. Apply approximately a 1/2- inch strip to the affected eye 2 to 4 (a) Specifications. Each milliliter of times a day. solution contains gentamicin sulfate equivalent to 3 milligrams of (2) Indications for use. For treatment gentamicin. of conjunctivitis caused by susceptible bacteria. (b) Sponsors. See Nos. 000061 and 059399 in § 510.600(c) of this chapter. (3) Limitations. Federal law restricts (c) Conditions of use in dogs and cats— this drug to use by or on the order of a (1) Amount. Administer 1 or 2 drops into licensed veterinarian. the conjunctival sac 2 to 4 times a day. [69 FR 47363, Aug. 5, 2004, as amended at 77 (2) Indications for use. For the topical FR 64717, Oct. 23, 2012] treatment of infections of the conjunctiva caused by susceptible bac- § 524.1044d Gentamicin and teria. betamethasone ointment. (3) Limitations. Federal law restricts (a) Specifications. Each gram of oint- this drug to use by or on the order of a ment contains gentamicin sulfate licensed veterinarian. equivalent to 3 milligrams of [80 FR 18776, Apr. 8, 2015] gentamicin base and betamethasone valerate equivalent to 1 milligram of § 524.1044b Gentamicin and betamethasone. betamethasone otic solution. (b) Sponsor. See No. 000061 in (a) Specifications. Each milliliter of § 510.600(c) of this chapter. solution contains gentamicin sulfate (c) Conditions of use in dogs—(1) equivalent to 3 milligrams (mg) Amount—(i) Otitis externa. Instill 3 to 8 gentamicin base and betamethasone drops into the ear canal twice daily for valerate equivalent to 1 mg 7 days. betamethasone alcohol. (ii) Infected superficial lesions. Apply (b) Sponsors. See Nos. 000061 and to cover the treatment area twice daily 054925 in § 510.600(c) of this chapter. for 7 to 14 days. (c) Conditions of use—(1) Amounts and (2) Indications for use. For the treat- indications for use—(i) For the treatment of acute and chronic otitis ment of acute and chronic otitis externa and infected superficial lesions externa caused by bacteria sensitive to caused by bacteria sensitive to gentamicin in dogs, instill three to gentamicin.

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(3) Limitations. Federal law restricts (3) Limitations. Federal law restricts this drug to use by or on the order of a this drug to use by or on the order of a licensed veterinarian. licensed veterinarian. [47 FR 26378, June 18, 1982, as amended at 52 [71 FR 13542, Mar. 16, 2006, as amended at 72 FR 7832, Mar. 13, 1987; 79 FR 10969, Feb. 27, FR 5929, Feb. 8, 2007; 74 FR 22822, May 15, 2014] 2009; 77 FR 3598, Jan. 25, 2012]

§ 524.1044e Gentamicin spray. § 524.1044g Gentamicin, betamethasone, and clotrimazole (a) Specification. Each milliliter of ointment. sterile aqueous solution contains (a) Specifications. Each gram (g) of gentamicin sulfate equivalent to 1.07 ointment contains gentamicin sulfate milligrams of gentamicin. equivalent to 3 milligrams (mg) (b) Sponsor. See No. 000061 in gentamicin base, betamethasone val- § 510.600(c) of this chapter. erate equivalent to 1 mg (c) Conditions of use in cattle—(1) betamethasone, and 10 mg Amount. Hold the sprayer upright 3 to 6 clotrimazole. inches from the affected eye, with the (b) Sponsors. See sponsors in opening directed towards the eye, and § 510.600(c) of this chapter for uses as in pump once. Treat once daily for up to paragraph (c) of this section. 3 days. (1) No. 000061 for use of 7.5- or 15-gram (2) Indications for use. For the treat- (g) tubes, 12.5-, 30-, or 215-g bottles. ment of pinkeye in cattle (infectious (2) No. 054925 for use of 7.5- or 15-g bovine keratoconjunctivitis) caused by tubes; 10-, 15-, 25-, or 215-g bottles. Moraxella bovis. (3) No. 069043 for use of 10-, 20-, 40-, or 215-g bottles. (3) Limitations. Conditions other than (4) No. 025463 for use of 7.5- or 15-g bacterial infections of the bovine eye tubes, or 215-g bottles. and infectious keratoconjunctivitis (c) Conditions of use in dogs—(1) caused by Moraxella bovis may produce Amount. Instill ointment twice daily similar signs. If conditions persists or into the ear canal for 7 consecutive increases, discontinue use and consult days. a veterinarian. (i) From 7.5- or 15-g tubes; 10-, 12.5-, [48 FR 41157, Sept. 14, 1983, as amended 52 FR 15-, 25-, or 30-g bottles: 4 drops for dogs 7833, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2014] weighing less than 30 pounds (lb) or 8 drops for dogs weighing 30 lb or more. § 524.1044f Gentamicin and (ii) From 20-, 40-, or 215-g bottles: 2 betamethasone spray. drops for dogs weighing less than 30 lb (a) Specifications. Each milliliter of or 4 drops for dogs weighing 30 lb or spray contains gentamicin sulfate more. (ii) From 20- or 215-g bottles: 2 drops equivalent to 0.57 milligram (mg) for dogs weighing less than 30 lb or 4 gentamicin base and betamethasone drops for dogs weighing 30 lb or more. valerate equivalent to 0.284 mg (2) Indications for use. For the treat- betamethasone. ment of acute and chronic canine otitis (b) Sponsors. See Nos. 000061, 054925, externa associated with yeast 058005, 058829, and 065531 in § 510.600(c) of (Malassezia pachydermatis, formerly this chapter. Pityrosporum canis) and/or bacteria sus- (c) Conditions of use in dogs—(1) ceptible to gentamicin. Amount. Hold bottle upright 3 to 6 (3) Limitations. Federal law restricts inches from the lesion and depress the this drug to use by or on the order of a sprayer head twice. Administer two licensed veterinarian. spray actuations two to four times [58 FR 38973, July 21, 1993, as amended at 63 daily for 7 days. FR 31932, June 11, 1998; 68 FR 42970, July 21, (2) Indications for use. For the treat- 2003; 70 FR 8291, Feb. 18, 2005; 71 FR 13542, ment of infected superficial lesions Mar. 16, 2006; 71 FR 16481, Apr. 3, 2006; 71 FR caused by bacteria susceptible to 38261, July 6, 2006; 71 FR 56867, Sept. 28, 2006; gentamicin. 78 FR 17597, Mar. 22, 2013; 79 FR 10969, Feb. 27, 2014; 81 FR 17608, Mar. 30, 2016]

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§ 524.1044h Gentamicin, mometasone, (3) Limitations. Federal law restricts and clotrimazole otic suspension. this drug to use by or on the order of a (a) Specifications. Each gram of sus- licensed veterinarian. pension contains gentamicin sulfate, [75 FR 54492, Sept. 8, 2010, as amended at 80 United States Pharmacopeia (USP) FR 13230, Mar. 13, 2015] equivalent to 3 milligram (mg) gentamicin base, mometasone furoate § 524.1132 Hydrocortisone, miconazole, monohydrate or mometasone furoate and gentamicin otic suspension. anhydrous, USP, equivalent to 1 mg (a) Specifications. Each milliliter mometasone, and 10 mg clotrimazole, (mL) of suspension contains 1.11 milli- USP. grams (mg) hydrocortisone aceponate, (b) Sponsors. See Nos. 000061 and 17.4 mg miconazole nitrate, and 1.5 mg 054925 in § 510.600(c) of this chapter. gentamicin (as gentamicin sulfate). (c) Conditions of use in dogs—(1) (b) Sponsor. See No.051311 in Amount. For dogs weighing less than 30 § 510.600(c) of this chapter. pounds (lb), instill 4 drops from the 7.5- (c) Conditions of use in dogs—(1) , 15-, or 30-gram (g) bottle into the ear Amount. Instill 1.0 mL in the affected canal (2 drops from the 215-g bottle) or, ear once daily for 5 days. for dogs weighing 30 lb or more, instill (2) Indications for use. For the treat- 8 drops from the 7.5-, 15-, or 30-g bottle ment of otitis externa in dogs associ- into the ear canal (4 drops from the 215- ated with susceptible strains of yeast g bottle), once or twice daily for 7 days. (Malassezia pachydermatis) and bacteria (2) Indications for use. For the treat- (Staphylococcus pseudintermedius). ment of otitis externa caused by sus- (3) Limitations. Federal law restricts ceptible strains of yeast (Malassezia this drug to use by or on the order of a pachydermatis) and bacteria licensed veterinarian. (Pseudomonas spp. [including P. aeruginosa], coagulase-positive [76 FR 78150, Dec. 16, 2011, as amended at 83 staphylococci, Enterococcus faecalis, FR 13635, Mar. 30, 2018] Proteus mirabilis, and beta-hemolytic § 524.1140 Imidacloprid and streptococci). ivermectin. (3) Limitations. Federal law restricts this drug to use by or on the order of a (a) Specifications. The product is licensed veterinarian. available in unit applicator tubes containing 0.4, 1.0, 2.5, or 4.0 milliliters [66 FR 712, Jan. 4, 2001, as amended at 68 FR (mL). Each mL of solution contains 100 15370, Mar. 31, 2003; 70 FR 36338, June 23, 2005; milligrams (mg) imidacloprid and 800 79 FR 10969, Feb. 27, 2014; 81 FR 59134, Aug. 29, micrograms (μg) ivermectin. 2016] (b) Sponsor. See No. 000859 in § 524.1044i Gentamicin and § 510.600(c) of this chapter. betamethasone ophthalmic solution. (c) Conditions of Use in Dogs—(1) Amount. The recommended minimum (a) Specifications. Each milliliter dosage is 4.5 mg/pound (lb) (10 mg/kilo- (mL) of solution contains gentamicin gram (kg)) of imidacloprid and 36.4 μg/ sulfate equivalent to 3 milligrams (mg) lb (80 μg/kg) of ivermectin, topically of gentamicin base and 1 mg betamethasone acetate equivalent to once a month. 0.89 mg betamethasone alcohol. (2) Indications for Use. For the preven- (b) Sponsor. See No. 000061 in tion of heartworm disease caused by § 510.600(c) of this chapter. Dirofilaria immitis; kills adult fleas and is indicated for the treatment of flea (c) Conditions of use in dogs—(1) infestations (Ctenocephalides felis). Amount. Instill one or two drops of solution in the conjunctival sac three or (3) Limitations. Federal law restricts four times a day. this drug to use by or on the order of a (2) Indications for use. For treatment licensed veterinarian. of external eye infections and inflam- [67 FR 78685, Dec. 26, 2002] mation.

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§ 524.1146 Imidacloprid and for the treatment of flea infestations moxidectin. on ferrets. (a) Specifications—(1) Each milliliter [72 FR 10597, Mar. 9, 2007, as amended at 78 of solution contains 100 milligrams FR 73698, Dec. 9, 2013] (mg) imidacloprid and 25 mg moxidectin for use as in paragraph § 524.1193 Ivermectin topical solution. (d)(1) of this section. (a) Specifications. Each milliliter (2) Each milliliter of solution con- (mL) of solution contains 5 milligrams tains 100 mg imidacloprid and 10 mg of ivermectin. moxidectin for use as in paragraphs (b) Sponsors. See sponsors in (d)(2) and (d)(3) of this section. § 510.600(c) of this chapter for use as in (b) Sponsor. See No. 000859 in paragraph (e) of this section. § 510.600(c) of this chapter. (1) Nos. 050604, 055529, 058829, 061623 (c) Special considerations. Federal law for use as in paragraphs (e)(1), (e)(2)(i), restricts this drug to use by or on the (e)(2)(iii), and (e)(3) of this section. order of a licensed veterinarian. (2) Nos. 016592, 054925, and 058005 for (d) Conditions of use—(1) Dogs—(i) use as in paragraphs (e)(1), (e)(2)(i), Amount. Topically apply 4.5 mg/lb body (e)(2)(ii), and (e)(3) of this section. weight (10 mg/kg) imidacloprid and 1.1 (c) Related tolerances. See § 556.344 of mg/lb (2.5 mg/kg) moxidectin, once a this chapter. month. (d) Special considerations. See § 500.25 (ii) Indications for use—(A) For the of this chapter. prevention of heartworm disease (e) Conditions of use in cattle—(1) caused by Dirofilaria immitis; and the Amount. One mL per 22 pounds (0.5 mil- treatment and control of intestinal ligram per kilogram) of body weight roundworms (Toxocara canis and applied topically to the back of the Toxascaris leonina), hookworms animal. (Ancylostoma caninum and Uncinaria (2) Indications for use—(i) It is used stenocephala), and whipworms (Trichuris for the treatment and control of: Gas- vulpis); kills adult fleas and treats flea trointestinal roundworms (adults and infestations (Ctenocephalides felis). fourth-stage larvae) Ostertagia ostertagi (including inhibited stage), Haemonchus (B) For treatment of Dirofilaria placei, Trichostrongylus axei, T. immitis circulating microfilariae in colubriformis, Cooperia oncophora, C. heartworm-positive dogs and the treat- punctata, C. surnabada, ment and control of sarcoptic mange Oesophagostomum radiatum; (adults) caused by Sarcoptes scabiei var. canis. Strongyloides papillosus, Trichuris spp.; (2) Cats—(i) Amount. Topically apply lungworms (adults and fourth-stage 4.5 mg/lb body weight (10 mg/kg) larvae) Dictyocaulus viviparus; cattle imidacloprid and 0.45 mg/lb (1.0 mg/kg) grubs (parasitic stages) Hypoderma moxidectin, once a month. bovis, H. lineatum; mites Sarcoptes (ii) Indications for use. For the pre- scabiei var. bovis; lice Linognathus vituli, vention of heartworm disease caused Haematopinus eurysternus, Damalinia by Dirofilaria immitis; for the treatment bovis, Solenoptes capillatus; and horn and control of ear mite (Otodectes flies Haematobia irritans. cynotis) infestations, intestinal (ii) It controls infections and pre- roundworms (Toxocara cati), and vents reinfection with O. ostertagi, O. hookworms (Ancylostoma tubaeforme); radiatum, H. placei, T. axei, C. punctata, kills adult fleas and treats flea infesta- and C. oncophora for 14 days after tions (Ctenocephalides felis). treatment. (3) Ferrets—(i) Amount. Topically (iii) It controls infections and pre- apply 9.0 mg/lb body weight (20 mg/kg) vents reinfection with O. radiatum and imidacloprid and 0.9 mg/lb (2 mg/kg) D. viviparus for 28 days after treatment, moxidectin, once a month. C. punctata and T. axei for 21 days after (ii) Indications for use. For the pre- treatment, O. ostertagi, H. placei, C. vention of heartworm disease caused oncophora, and C. surnabada for 14 days by Dirofilaria immitis; kills adult fleas after treatment, and D. bovis for 56 (Ctenocephalides felis) and is indicated days after treatment.

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(3) Limitations. Do not treat cattle least 48 hours after the eye appears within 48 days of slaughter. Because a normal. withdrawal time in milk has not been (2) Indications for use. For the treat- established, do not use in female dairy ment of various eye infections (con- cattle of breeding age. A withdrawal junctivitis, blepharitis, dacryocystitis, period has not been established for this keratitis, and corneal ulcerations) due product on preruminating calves. Do to bacteria sensitive to kanamycin. not use on calves to be processed for For prophylaxis in traumatic condi- veal. tions, removal of foreign bodies, and [55 FR 50551, Dec. 7, 1990, as amended at 62 intraocular surgery. FR 38908, July 21, 1997; 62 FR 63271, Nov. 28, (3) Limitations. Federal law restricts 1997; 63 FR 44385, Aug. 19, 1998; 66 FR 13236, this drug to use by or on the order of a Mar. 5, 2001; 66 FR 63165, Dec. 5, 2001; 68 FR licensed veterinarian. 3817, Jan. 27, 2003; 68 FR 4713, Jan. 30, 2003; 69 FR 501, Jan. 6, 2004; 69 FR 62181, Oct. 25, 2004; [79 FR 10969, Feb. 27, 2014] 71 FR 13542, Mar. 16, 2006; 72 FR 6464, Feb. 12, 2007; 74 FR 36112, July 22, 2009; 75 FR 26648, § 524.1200b Kanamycin ophthalmic so- May 12, 2010; 76 FR 81807, Dec. 29, 2011; 78 FR lution. 17597, Mar. 22, 2013; 78 FR 63872, Oct. 25, 2013; (a) Specifications. Each milliliter of 81 FR 25328, Apr. 28, 2016; 83 FR 13635, Mar. 30, solution contains 10 milligrams 2018] kanamycin activity as kanamycin sulfate. § 524.1195 Ivermectin otic suspension. (b) Sponsor. See No. 054771 in (a) Specifications. Each tube contains § 510.600(c) of this chapter. 0.5 milliliter (mL) of a 0.01 percent sus- (c) Conditions of use in dogs—(1) pension of ivermectin. Amount. Instill a few drops into the af- (b) Sponsor. See No. 000010 in fected eye every 3 hours or more fre- § 510.600(c) of this chapter. quently if deemed advisable. Admin- (c) Conditions of use—(1) Amount. Ad- ister as frequently as possible for the minister the contents of one 0.5-mL first 48 hours, after which the fre- tube topically into each external ear quency of applications may be decanal. creased. Treatment should be contin- (2) Indications for use. For the treat- ued for at least 48 hours after the eye ment of adult ear mite (Otodectes appears normal. cynotis) infestations in cats and kittens (2) Indications for use. For the treat- 4 weeks of age and older. Effectiveness ment of various eye infections (con- against eggs and immature stages has junctivitis, blepharitis, dacryocystitis, not been proven. keratitis, and corneal ulcerations) due (3) Limitations. Federal law restricts to bacteria sensitive to kanamycin. this drug to use by or on the order of a For prophylaxis in traumatic condi- licensed veterinarian. tions, removal of foreign bodies, and [66 FR 7578, Jan. 24, 2001, as amended at 74 intraocular surgery. FR 26782, June 4, 2009] (3) Limitations. Federal law restricts this drug to use by or on the order of a § 524.1200 Kanamycin ophthalmic and licensed veterinarian. topical dosage forms. [79 FR 10970, Feb. 27, 2014] § 524.1200a Kanamycin ophthalmic ointment. § 524.1204 Kanamycin, amphomycin, (a) Specifications. Each gram of oint- and hydrocortisone ointment. ment contains 3.5 milligrams (a) Specifications. Each gram of oint- kanamycin activity as kanamycin sul- ment contains 5 milligrams kanamycin fate. activity as kanamycin sulfate, 5 milli- (b) Sponsor. See No. 054771 in grams of amphomycin activity as the § 510.600(c) of this chapter. calcium salt, and 10 milligrams of hy- (c) Conditions of use in dogs—(1) drocortisone acetate. Amount. Apply a thin film to the af- (b) Sponsor. See No. 054771 in fected eye three or four times daily or § 510.600(c) of this chapter. more frequently if deemed advisable. (c) Conditions of use in dogs—(1) Treatment should be continued for at Amount. Apply to the affected areas of

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the skin at least twice daily. In severe § 524.1376 2-Mercaptobenzothiazole so- or widespread lesions it may be desir- lution. able to apply the ointment more than (a) Specifications. The drug contains twice daily. After some improvement is 1.3 percent 2-mercaptobenzothiazole in observed, treatment can usually be re- a suitable solvent. duced to once daily. (2) Indications for use. For the treat- (b) Sponsor. See 017135 in § 510.600(c) of ment of acute otitis externa, furuncu- this chapter. losis, folliculitis, pruritus, anal gland (c) Conditions of use—(1) Amount. infections, erythema, decubital ulcers, Apply twice daily to affected area. superficial wounds, and superficial ab- (2) Indications for use. For dogs as an scesses associated with bacterial infec- aid in the treatment of hot spots tions caused by organisms susceptible (moist dermatitis) and as first aid for to one or both antibiotics. scrapes and abrasions. (3) Limitations. Federal law restricts (3) Limitations. Clip hair from affected this drug to use by or on the order of a area before applying. If no improve- licensed veterinarian. ment is seen within 1 week, consult a [79 FR 10970, Feb. 27, 2014] veterinarian. [48 FR 15618, Apr. 12, 1983, as amended at 65 § 524.1240 Levamisole. FR 50913, Aug. 22, 2000; 68 FR 33381, June 4, (a) Specifications. The drug contains 2003] 200 milligrams of levamisole per milliliter of diethylene glycol monobutyl § 524.1443 Miconazole. ether (DGME) solution. (a) Specifications—(1) Each gram of (b) Sponsors. See Nos. 000061 and cream contains miconazole nitrate 054771 in § 510.600(c) of this chapter. equivalent to 20 milligrams miconazole (c) Related tolerances. See § 556.350 of base. this chapter. (2) Each gram of lotion or spray con- (d) Conditions of use. Cattle—(1) tains miconazole nitrate equivalent to Amount. 2.5 milliliters per 110 pounds 1 percent miconazole base. (10 milligrams of levamisole per kilo- (b) Sponsors. See § 510.600(c) of this gram) of body weight as a single dose topically to the back of the animal. chapter for use as in paragraph (c) of (2) Indications for use. Anthelmintic this section: effective against stomach worms (1) No. 000061 for use of cream, lotion, (Haemonchus, Trichostrongylus, and spray; Ostertagia), intestinal worms (2) Nos. 054925 and 058829 for use of lo- (Trichostrongylus, Cooperia, tion and spray. Nematodirus, Bunostomum, (c) Conditions of use in dogs and cats— Oesophagostomum, Chabertia), and (1) Amount. Apply once daily by rub- lungworms (Dictyocaulus). bing into or spraying a light covering (3) Limitations. Conditions of constant on the infected site and the immediate helminth exposure may require re- surrounding vicinity. Continue treat- treatment within 2 to 4 weeks after the ment for 2 to 4 weeks until infection is first treatment. Cattle must not be completely eradicated as determined slaughtered within 9 days following by appropriate laboratory examina- last treatment. Do not administer to tion. dairy animals of breeding age. Do not (2) Indications for use. For topical treat animals before dipping or prior to treatment of infections caused by exposure to heavy rain. Consult your Microsporum canis, Microsporum veterinarian for assistance in the diag- gypseum, and Trichophyton nosis, treatment, and control of parasitism, and before using in severely de- mentagrophytes. bilitated animals. (3) Limitations. Federal law restricts this drug to use by or on the order of a [52 FR 10887, Apr. 6, 1987, as amended at 53 licensed veterinarian. FR 7504, Mar. 9, 1988; 62 FR 61626, Nov. 19, 1997; 67 FR 78355, Dec. 24, 2002; 79 FR 10970, [71 FR 13542, Mar. 16, 2006] Feb. 27, 2014]

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§ 524.1445 Miconazole, polymixin B, tion as in paragraph (d)(1) of this sec- and prednisolone suspension. tion; (a) Specifications. Each milliliter of (2) No. 000859 for use of product de- suspension contains 23 milligrams (mg) scribed in paragraph (a)(2) of this sec- miconazole nitrate, 0.5293 mg tion as in paragraph (d)(2) of this sec- polymixin B sulfate, and 5 mg prednis- tion. olone acetate. (c) Related tolerances. See § 556.426 of this chapter. (b) Sponsor. See No. 058198 in (d) —(1) —(i) § 510.600(c) of this chapter. Conditions of use Cattle Amount. Administer topically 0.5 mg (c) Conditions of use in dogs—(1) per kilogram (kg) of body weight. Amount. Instill five drops in the ear (ii) Indications for use. Beef and dairy canal twice daily for 7 consecutive cattle: For treatment and control of in- days. ternal and external parasites: gastro- (2) For the treat- Indications for use. intestinal roundworms (Ostertagia ment of canine otitis externa associ- ostertagi (adult and L4, including inhib- ated with susceptible strains of yeast ited larvae), Haemonchus placei (adult ( ) and bacteria Malassezia pachydermatis and L4), Trichostrongylus axei (adult ( ). Staphylococcus pseudintermedius and L4), T. colubriformis (adult and L4), (3) Limitations. Federal law restricts Cooperia oncophora (adult and L4), C. this drug to use by or on the order of a pectinata (adult), C. punctata (adult and licensed veterinarian. L4), C. spatulata (adult), C. surnabada [ 75 FR 4693, Jan. 29, 2010, as amended at 77 (adult and L4), Bunostomum FR 46613, Aug. 6, 2012; 81 FR 48703, July 26, phlebotomum (adult), Oesophagostomum 2016] radiatum (adult and L4), Nematodirus helvetianus (adult and L4)); lungworms § 524.1446 Milbemycin otic solution. (Dictyocaulus viviparus (adult and L4)); (a) Specifications. Each tube contains cattle grubs (Hypoderma bovis, H. 0.25 milliliter of a 0.1 percent solution lineatum); mites (Chorioptes bovis, of milbemycin oxime. Psoroptes ovis (P. communis var. bovis)); (b) Sponsor. See No. 058198 in lice (Linognathus vituli, Haematopinus § 510.600(c) of this chapter. eurysternus, Solenopotes capillatus, (c) Conditions of use—(1) Amount. One Bovicola (Damalinia) bovis); and horn tube administered topically into each flies (Haematobia irritans). To control external ear canal. infections and to protect from reinfec- (2) Indications for use. For the treat- tion with H. placei for 14 days after ment of ear mite (Otodectes cynotis) in- treatment, O. radiatum and O. ostertagi festations in cats and kittens 4 weeks for 28 days after treatment, and D. of age and older. Effectiveness is main- viviparus for 42 days after treatment. tained throughout the life cycle of the (iii) Limitations. A withdrawal period ear mite. has not been established for this prod- (3) Limitations. Federal law restricts uct on preruminating calves. Do not this drug to use by or on the order of a use on calves to be processed for veal. licensed veterinarian. See § 500.25 of this chapter. (2) Dogs—(i) Amount. Administer topi- [65 FR 13905, Mar. 15, 2000, as amended at 66 cally a minimum of 1.1 mg per pound FR 13849, Mar. 8, 2001] (lb) (2.5 mg/kg) of body weight, once monthly using the appropriate pre- § 524.1450 Moxidectin. loaded applicator tube. (a) Specifications. Each milliliter of (ii) Indications for use. For the pre- solution contains: vention of heartworm disease caused (1) 5 milligrams (mg) moxidectin (0.5 by Dirofilaria immitis, as well as the percent solution). treatment and control of intestinal (2) 25 mg moxidectin (2.5 percent so- hookworm (Ancylostoma caninum lution). (adult, immature adult, and L4 larvae) (b) Sponsors. See sponsor numbers in and Uncinaria stenocephala (adult, im- § 510.600 of this chapter: mature adult, and L4 larvae)), (1) No. 000859 for use of product de- roundworm (Toxocara canis (adult and scribed in paragraph (a)(1) of this sec- L4 larvae) and Toxascaris leonina

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(adult)), and whipworm (Trichuris vulpis perficial dressing applied to minor (adult)) infections in dogs and puppies cuts, wounds, lacerations, abrasions, that are at least 7 weeks of age and and for postsurgical application where that weigh at least 3 lbs. reduction of pain and inflammatory re- (iii) Limitations. Federal law restricts sponse is deemed desirable; as a dust- this drug to use by or on the order of a ing powder following amputation of licensed veterinarian. tails, claws, and dewclaws and fol- [63 FR 14036, Mar. 24, 1998, as amended at 65 lowing ear trimming, castrating, and FR 36617, June 9, 2000; 66 FR 46370, Sept. 5, such surgical procedures as 2001. Redesignated at 76 FR 48715, Aug. 9, ovariohysterectomies. For the treat- 2011, as amended at 80 FR 53460, Sept. 4, 2015; ment of acute otitis externa, acute 82 FR 21691, May 10, 2017] moist dermatitis, and interdigital dermatitis in dogs. § 524.1465 Mupirocin. (3) Limitations. Federal law restricts (a) Specifications. Each gram of oint- this drug to use by or on the order of a ment contains 20 milligrams licensed veterinarian. mupirocin. (b) Sponsors. See Nos. 025463, 051672, [40 FR 13873, Mar. 27, 1975, as amended at 43 and 054771 in § 510.600(c) of this chapter. FR 18172, Apr. 28, 1978; 79 FR 10970, Feb. 27, (c) Conditions of use in dogs—(1) 2014] Amount. Apply twice daily. Treatment should not exceed 30 days. § 524.1484c Neomycin, isoflupredone, (2) Indications for use. For the topical and tetracaine ointment. treatment of bacterial infections of the (a) Specifications. The drug contains 5 skin, including superficial pyoderma, milligrams of neomycin sulfate (equiv- caused by susceptible strains of Staphy- alent to 3.5 milligrams of neomycin lococcus aureus and S. intermedius. base), 1 milligram of isoflupredone ace- (3) Limitations. Federal law restricts tate, and 5 milligrams of tetracaine hy- this drug to use by or on the order of a drochloride in each gram of ointment. licensed veterinarian. (b) Sponsor. See No. 054771 in [72 FR 18119, Apr. 11, 2007, as amended at 75 § 510.600(c) of this chapter. FR 79296, Dec. 20, 2010; 78 FR 52854, Aug. 27, (c) Conditions of use in dogs—(1) 2013; 79 FR 10970, Feb. 27, 2014; 82 FR 11508, Amount. In treatment of otitis externa Feb. 24, 2017] and other inflammatory conditions of the external ear canal, a quantity of § 524.1484 Neomycin ophthalmic and ointment sufficient to fill the external topical dosage forms. ear canal; may be applied one to three § 524.1484b Neomycin, isoflupredone, times daily. When used on the skin or tetracaine, and myristyl-gamma- mucous membranes, the affected area picolinium powder. should be cleansed, and a small amount (a) Specifications. The product con- of the ointment applied and spread or tains 5 milligrams of neomycin sulfate, rubbed in gently. The involved area equivalent to 3.5 milligrams of neomy- may be treated one to three times a cin base, 1 milligram of isoflupredone day and these daily applications con- acetate, 5 milligrams of tetracaine hy- tinued in accordance with the clinical drochloride and .2 milligram of response. myristyl-gamma-picolinium chloride (2) Indications for use. For the treat- in each gram of the product in a special ment of acute otitis externa in dogs adherent powder base. and to a lesser degree, chronic otitis (b) Sponsor. See No. 054771 in externa in dogs. It also is effective in § 510.600(c) of this chapter. treating anal gland infections and (c) Conditions of use in horses, dogs, moist dermatitis in the dog and is a and cats—(1) Amount. Apply to affected useful dressing for minor cuts, lacera- areas as a dusting powder. tions, abrasions, and post-surgical (2) Indications for use. For the treat- therapy in the horse, cat, and dog. It ment or as adjunctive therapy of cer- may also be used following amputation tain ear and skin conditions caused by of dewclaws, tails and claws, following or associated with neomycin-suscep- ear trimming and castrating oper- tible organisms and/or allergy; as a su- ations.

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(3) Limitations. Federal law restricts § 524.1484f Neomycin, prednisolone, this drug to use by or on the order of a and tetracaine otic suspension. licensed veterinarian. (a) Specifications. The product con- [40 FR 13873, Mar. 27, 1975, as amended at 43 tains 5 milligrams of neomycin sulfate FR 18172, Apr. 28, 1978; 79 FR 10970, Feb. 27, equivalent to 3.5 milligrams of neomy- 2014] cin base, 2.5 milligrams of prednisolone § 524.1484d Neomycin, hydrocortisone, acetate, and 5 milligrams of tetracaine and tetracaine otic ointment. hydrochloride in each milliliter of ster- (a) Specifications. The product con- ile suspension. tains 5 milligrams of neomycin sulfate, (b) Sponsor. See No. 054771 in equivalent to 3.5 milligrams of neomy- § 510.600(c) of this chapter. cin base, 5 milligrams of hydro- (c) Conditions of use in dogs and cats— cortisone acetate, and 5 milligrams of (1) Amount. Instill 2 to 6 drops in the tetracaine hydrochloride in each gram external ear canal 2 or 3 times daily. of ointment. (2) Indications for use. For the treat- (b) Sponsor. See No. 054771 in ment of acute otitis externa and, to a § 510.600(c) of this chapter. lesser degree, chronic otitis externa; as (c) Conditions of use in dogs and cats— treatment or adjunctive therapy of cer- (1) Amount. Instill a quantity of oint- tain ear conditions caused by or associ- ment sufficient to fill the external ear ated with neomycin-susceptible orga- canal; may be applied one to three nisms and/or allergy. times daily. (2) Indications for use. For the treat- (3) Limitations. Federal law restricts ment of ear canker and other inflam- this drug to use by or on the order of a matory conditions of the external ear licensed veterinarian. canal, acute otitis externa and, to a [40 FR 13873, Mar. 27, 1975, as amended at 79 lesser degree, chronic otitis externa. FR 10971, Feb. 27, 2014] (3) Limitations. Federal law restricts this drug to use by or on the order of a § 524.1484g Neomycin, thiabendazole, licensed veterinarian. and dexamethasone solution. [40 FR 13873, Mar. 27, 1975, as amended at 49 (a) Specifications. Each milliliter of FR 21922, May 24, 1984; 79 FR 10970, Feb. 27, solution contains 40 milligrams (mg) 2014] thiabendazole, 3.2 mg neomycin (from § 524.1484e Neomycin and polymyxin B neomycin sulfate), and 1 mg dexa- ophthalmic solution. methasone. (a) Specifications. Each milliliter of (b) Sponsors. See Nos. 026637 and the ophthalmic preparation contains 050604 in § 510.600(c) of this chapter. 5.0 milligrams neomycin sulfate (3.5 (c) Conditions of use in dogs and cats— milligrams neomycin base), and 10,000 (1) Amount. In treating dermatoses af- Units of polymyxin B sulfate. fecting areas other than the ear, the (b) Sponsor. See No. 054771 in surface of the lesions should be well § 510.600(c) of this chapter. moistened (2 to 4 drops per square inch) (c) Conditions of use in dogs—(1) twice daily. In treating otitis externa, Amount. Instill 1 to 2 drops per eye instill 5 to 15 drops in the ear twice every 6 hours. daily. Treat for up to 7 days. (2) Indications for use. For the treat- (2) Indications for use. As an aid in the ment of bacterial infections associated treatment of bacterial, mycotic, and with topical ophthalmological condi- inflammatory dermatoses and otitis tions such as corneal injuries, super- externa. ficial keratitis, conjunctivitis, (3) Limitations. Federal law restricts keratoconjunctivitis, and blepharitis. this drug to use by or on the order of a (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. licensed veterinarian. [40 FR 13873, Mar. 27, 1975, as amended at 62 [40 FR 13873, Mar. 27, 1975, as amended at 61 FR 63271, Nov. 28, 1997; 79 FR 10971, Feb. 27, FR 5507, Feb. 13, 1996; 79 FR 10970, Feb. 27, 2014; 80 FR 61297, Oct. 13, 2015] 2014]

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§ 524.1484h Neomycin, penicillin, poly- (c) Conditions of use in dogs and cats— myxin B, and hydrocortisone sus- (1) Amount. Apply 3 or 4 times daily pension. into the conjunctival sac. With im- (a) Specifications. Each milliliter of provement, frequency may be reduced suspension contains 25 milligrams of to 2 or 3 times daily. For treatment of neomycin sulfate equivalent to 17.5 ear canker and other inflammatory milligrams of neomycin, 10,000 inter- conditions of the external ear canal, national units of penicillin G procaine, fill external ear canal 1 to 3 times 5,000 international units of polymyxin daily. B sulfate, 2 milligrams of hydro- (2) Indications for use. For the treat- cortisone acetate, and 1.25 milligrams ment of infections, allergic and trau- of hydrocortisone sodium succinate. matic keratitis, conjunctivitis, acute (b) Sponsor. See No. 054771 in otitis externa and, to a lesser degree, § 510.600(c) of this chapter. chronic otitis externa. (c) Conditions of use in dogs—(1) (3) Limitations. Federal law restricts Amount. Rub a small amount into the this drug to use by or on the order of a affected area 1 to 3 times a day. After licensed veterinarian. definite improvement, apply once daily or every other day. [43 FR 40456, Sept. 12, 1978, as amended at 79 (2) Indications for use. For the treat- FR 10971, Feb. 27, 2014] ment of summer eczema, atopic dermatitis, interdigital eczema, and otitis § 524.1484j Neomycin and prednisolone externa caused by bacteria susceptible ophthalmic ointment. to neomycin, penicillin, and polymyxin (a) Specifications. Each gram of oint- B. ment contains prednisolone sodium (3) Limitations. Federal law restricts phosphate equivalent to 2.5 milligrams this drug to use by or on the order of a prednisolone 21-phosphate and 5 milli- licensed veterinarian. grams neomycin sulfate equivalent to (d) Conditions of use—dogs—(1) 3.5 milligrams neomycin base. Amount. Rub a small amount into the (b) Sponsor. See No. 050604 in involved area 1 to 3 times a day. After § 510.600(c) of this chapter. definite improvement, it may be ap- (c) Conditions of use in dogs and cats— plied once a day or every other day. (1) Amount. A small quantity of the (2) Indications for use. Treatment of ointment should be expressed into the summer eczema, atopic dermatitis, conjunctival sac 4 times a day (at in- interdigital eczema, and otitis externa tervals of 1 to 8 hours) for a few days caused by bacteria susceptible to neo- until there is a favorable response, mycin, penicillin, and polymyxin B. then the frequency of application may (3) Limitations. For use in dogs only. be reduced to twice daily as long as the Shake drug thoroughly and clean le- condition remains under control. sion before using. If redness, irritation, Treatment may require from a few or swelling persists or increases, dis- days to several weeks. continue use and reevaluate diagnosis. (2) Indications for use. For use in su- Federal law restricts this drug to use perficial ocular inflammations or infec- by or on the order of a licensed veteri- tions limited to the conjunctiva or the narian. anterior segment of the eye, such as [59 FR 5105, Feb. 3, 1994, as amended at 79 FR those associated with allergic reactions 10971, Feb. 27, 2014] or gross irritants. (3) Limitations. Federal law restricts § 524.1484i Neomycin and hydro- this drug to use by or on the order of a cortisone ointment. licensed veterinarian. (a) Specifications. The drug contains 5 milligrams of neomycin sulfate, equiv- [79 FR 10971, Feb. 27, 2014] alent to 3.5 milligrams of neomycin base, and 5 milligrams of hydro- § 524.1484k Neomycin and prednis- cortisone acetate in each gram of oint- olone suspension. ment.1 (a) Specifications. Each milliliter of (b) Sponsor. See No. 054771 in suspension contains 2.5 milligrams of § 510.600(c) of this chapter. prednisolone acetate and 5 milligrams

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of neomycin sulfate equivalent to 3.5 swelling persists or increases, dis- milligrams of neomycin base. continue use; consult veterinarian. (b) Sponsor. See No. 054771 in [46 FR 43402, June 27, 1980. Redesignated at 79 § 510.600(c) of this chapter. FR 10971, Feb. 27, 2014] (c) Conditions of use in dogs and cats— EDITORIAL NOTE: For FEDERAL REGISTER ci- (1) Amount. For beginning treatment of tations affecting § 524.1580a, see the List of acute ocular inflammations place 1 or 2 CFR Sections Affected, which appears in the drops in the conjunctival sac 3 to 6 Finding Aids section of the printed volume times during a 24 hour period. When and at www.fdsys.gov. improvement occurs, reduce the dosage to 1 drop 2 to 4 times daily. For otitis § 524.1580b Nitrofurazone soluble pow- externa, place 2 to 6 drops in the exter- der. nal ear canal 2 or 3 times daily. (a) Specifications. The drug contains (2) Indications for use. For the treat- 0.2 percent nitrofurazone in a water- ment of treating infectious, allergic soluble base. and traumatic keratitis and conjunc- (b) Sponsor. See Nos. 054628 and 059051 tivitis, acute otitis externa, and chron- in § 510.600(c) of this chapter. ic otitis externa. (c) Conditions of use—(1) Amount. (3) Limitations. Federal law restricts Apply several times daily to the lesion this drug to use by or on the order of a or affected area from the plastic licensed veterinarian. squeeze bottle. (2) Indications for use. For prevention [79 FR 10971, Feb. 27, 2014] or treatment of surface bacterial infections of wounds, burns, skin ulcers, and § 524.1580 Nitrofurazone topical dos- abscesses after incision. age forms. (3) Limitations. In case of deep or puncture wounds or serious burns, use § 524.1580a Nitrofurazone ointment. only as recommended by veterinarian. (a) Specifications. The drug contains If redness, irritation, or swelling per- 0.2 percent nitrofurazone in a water- sists or increases, discontinue use; con- soluble base. sult veterinarian. For use only on dogs, (b) Sponsors. See sponsors in cats, and horses (not for food use). § 510.600(c) of this chapter. [45 FR 43402, June 27, 1980, as amended at 47 (1) See Nos. 054628, 054925, 058005, FR 43368, Oct. 1, 1982; 48 FR 28984, June 24, 059051, and 061623 for use on dogs, cats, 1983; 53 FR 40728, Oct. 18, 1988; 54 FR 30542, or horses. July 21, 1989; 56 FR 50653, Oct. 8, 1991; 59 FR (2) See No. 017135 for use on dogs and 33197, June 28, 1994; 60 FR 55659, Nov. 2, 1995; horses. 62 FR 35077, June 30, 1997; 76 FR 17778, Mar. (3) See Nos. 017153 and 058829 for use 31, 2011; 78 FR 21060, Apr. 9, 2013. Redesig- on horses. nated at 79 FR 10971, Feb. 27, 2014, as amended at 79 FR 64117, Oct. 28, 2014] (c) [Reserved] (d) Conditions of use—(1) Amount. § 524.1580c Nitrofurazone and buta- Apply directly on the lesion with a caine ointment. spatula or first place on a piece of (a) Specifications. The drug contains gauze. The preparation should remain 0.2 percent nitrofurazone and 0.5 per- on the lesion for at least 24 hours. Use cent butacaine sulfate in a water-solu- of a bandage is optional. ble base. (2) Indications for use. For prevention (b) Sponsor. See No. 054925 in or treatment of surface bacterial infec- § 510.600(c) of this chapter. tions of wounds, burns, and cutaneous (c) Conditions of use—(1) Indications ulcers of dogs, cats, or horses. for use. For prevention or treatment of (3) Limitations. For use only on dogs, surface bacterial infections of ears, cats, and horses. Do not use on horses wounds, burns, and cutaneous ulcers of intended for human consumption. Fed- dogs, cats, and horses. eral law prohibits the use of this prod- (2) Limitations. Apply directly on the uct in food-producing animals. In case lesion with a spatula or first place on a of deep or puncture wounds or serious piece of gauze. Use of a bandage is op- burns, use only as recommended by tional. The preparation should remain veterinarian. If redness, irritation, or on the lesion for at least 24 hours. The

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dressing may be changed several times in dogs and cats for the treatment of daily or left on the lesion for a longer acute and chronic otitis and interdig- period. For use only on dogs, cats, and ital cysts, and in dogs for anal gland horses (not for food use). In case of infections. deep or puncture wounds or serious (3) Limitations. Federal law restricts burns, use only as recommended by a this drug to use by or on the order of a veterinarian. If redness, irritation, or licensed veterinarian. swelling persists or increases, dis- [40 FR 13873, Mar. 27, 1975, as amended at 43 continue use; consult veterinarian. FR 29770, July 11, 1978; 50 FR 41490, Oct. 11, [49 FR 9417, Mar. 13, 1984, as amended at 71 1985; 53 FR 39257, Oct. 6, 1988; 54 FR 5431, Feb. FR 13542, Mar. 16, 2006. Redesignated at 79 FR 3, 1989; 54 FR 48090, Nov. 21, 1989; 56 FR 50653, 10971, Feb. 27, 2014; 79 FR 10971, Feb. 27, 2014] Oct. 8, 1991; 60 FR 55660, Nov. 2, 1995; 61 FR 63712, Dec. 2, 1996; 64 FR 42831, Aug. 6, 1999; 67 FR 67521, Nov. 6, 2002; 68 FR 55201, Sept. 23, § 524.1600 Nystatin ophthalmic and 2003; 70 FR 50183, Aug. 26, 2005; 71 FR 13542, topical dosage forms. Mar. 16, 2006; 79 FR 10972, Feb. 27, 2014]

§ 524.1600a Nystatin, neomycin, § 524.1600b Nystatin, neomycin, thiostrepton, and triamcinolone thiostrepton, and triamcinolone ointment. ophthalmic ointment. (a) Specifications. Each milliliter of (a) Specifications. Each cubic centi- petrolatum base or each gram of van- meter of ointment contains: 100,000 ishing cream base ointment contains: units of nystatin, neomycin sulfate 100,000 units of nystatin; neomycin sul- equivalent to 2.5 milligrams of neomy- fate equivalent to 2.5 milligrams of ne- cin base, 2,500 units of thiostrepton, omycin base; 2,500 units of and 1.0 milligram of triamcinolone thiostrepton; and 1.0 milligram of acetonide. triamcinolone acetonide. (b) Sponsor. See No. 053501 in (b) Sponsors. For petrolatum base § 510.600(c) of this chapter. ointments see Nos. 000856, 025463, 054771, (c) Conditions of use—(1) Dogs and and 054925 in § 510.600(c) of this chapter. cats—(i) Amount. Apply 1 drop of oint- For vanishing cream base ointments ment to the affected eye(s) 2 or 3 times see Nos. 025463, 054771, and 054925. daily. Treatment may be continued for (c) Conditions of use—(1) Amount. (i) up to 2 weeks if necessary. For topical dermatological use: Clean (ii) Indications for use. For use as an affected areas and remove any en- anti-inflammatory, antipruritic, crusted discharge or exudate, and apply antifungal (Candida albicans), and anti- sparingly either ointment in a thin bacterial ointment for local therapy in film. keratitis and conjunctivitis. (ii) For otic use: Clean ear canal of (iii) Limitations. Federal law restricts impacted cerumen, remove any foreign this drug to use by or on the order of a bodies such as grass awns and ticks, licensed veterinarian. and instill three to five drops of petro- (2) Cattle—(i) Amount. Apply small latum base ointment. Preliminary use line of ointment to the affected eye(s) of a local anesthetic may be advisable. once daily. Treatment may be contin- (iii) For infected anal glands and cys- ued for up to 2 weeks if necessary. tic areas: Drain gland or cyst and fill (ii) Indications for use. For infectious with petrolatum base ointment. kerato-conjunctivitis (pinkeye). (2) Indications for use. (i) Topically: (iii) Limitations. Federal law restricts Use either ointment in dogs and cats this drug to use by or on the order of a for anti-inflammatory, antipruritic, licensed veterinarian. antifungal, and antibacterial treat- [40 FR 13873, Mar. 27, 1975, as amended at 50 ment of superficial bacterial infec- FR 41490, Oct. 11, 1985; 79 FR 10972, Feb. 27, tions, and for dermatologic disorders 2014] characterized by inflammation and dry or exudative dermatitis, particularly § 524.1610 Orbifloxacin, mometasone associated with bacterial or candidal furoate monohydrate, and (Candida albicans) infections. posaconazole suspension. (ii) Otitis, cysts, and anal gland in- (a) Specifications. Each gram of sus- fections: Use petrolatum base ointment pension contains 10 milligrams (mg)

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orbifloxacin, mometasone furoate after the initial favorable response has monohydrate equivalent to 1 mg been obtained. mometasone furoate, and 1 mg (2) Indications for use. For the relief of posaconazole. discomfort and continued treatment of (b) Sponsor. See No. 000061 in many allergic, infectious, and trau- § 510.600(c) of this chapter. matic skin conditions; for the preven- (c) Conditions of use in dogs—(1) tion of bacterial infections in super- Amount. For dogs weighing less than 30 ficial wounds, cuts, and abrasions, lbs. instill 4 drops once daily into the treatment of allergic dermatoses, in- ear canal. For dogs weighing 30 lbs. or cluding urticaria, eczemas, insect more, instill 8 drops into the ear canal. bites, and cutaneous drug reactions, in- Therapy should continue for 7 consecu- fections associated with minor burns tive days. and wounds, and nonspecific pruritus. (2) Indications for use. For the treat- (3) Limitations. Keep away from eyes ment of otitis externa associated with or other mucous membranes; avoid in- susceptible strains of yeast (Malassezia haling; use with adequate ventilation; pachydermatis) and bacteria (coagulase- in case of deep or puncture wounds or positive staphylococci, Pseudomonas serious burns, consult a veterinarian. aeruginosa, and Enterococcus faecalis). [40 FR 13873, Mar. 27, 1975, as amended at 79 (3) Limitations. Federal law restricts FR 10972, Feb. 27, 2014] this drug to use by or on the order of a licensed veterinarian. § 524.1662b Oxytetracycline and polymyxin B ophthalmic ointment. [75 FR 16346, Apr. 1, 2010] (a) Specifications. Each gram of the § 524.1662 Oxytetracycline ophthalmic ointment contains oxytetracycline hy- and topical dosage forms. drochloride equivalent to 5 milligrams of oxytetracycline and 10,000 units of § 524.1662a Oxytetracycline and hydro- polymyxin B sulfate. cortisone spray. (b) Sponsor. See No. 054771 in (a) Specifications. Each 3-ounce unit § 510.600(c) of this chapter. of oxytetracycline hydrochloride and (c) Conditions of use in dogs and cats— hydrocortisone spray contains 300 mil- (1) Amount. Administer topically to the ligrams of oxytetracycline hydro- eye two to four times daily. chloride and 100 milligrams of hydro- (2) Indications for use. For the prophy- cortisone with an inert freon propel- laxis and local treatment of superficial lant such that a 1-second spray treat- ocular infections due to ment will deliver approximately 2.5 oxytetracycline- and polymyxin-sen- milligrams of oxytetracycline hydro- sitive organisms including ocular in- chloride and 0.8 milligram of hydro- fections due to streptococci, cortisone. rickettsiae, E. coli, and A. aerogenes (b) Sponsor. See No. 054771 in (such as conjunctivitis, keratitis, pink- § 510.600(c) of this chapter. eye, corneal ulcer, and blepharitis in (c) Conditions of use in dogs and cats— dogs, cats, cattle, sheep, and horses); (1) Amount. A small quantity should be ocular infections due to secondary bac- sprayed on the affected surface by terial complications associated with holding the container about 6 inches distemper in dogs; and ocular infec- from the area to be treated and press- tions due to bacterial inflammatory ing the nozzle for 1 or 2 seconds. Only conditions which may occur secondary sufficient spray to coat the skin thinly to other infectious diseases in dogs, is necessary. The application of small cats, cattle, sheep, and horses. amounts at frequent intervals will give (3) Limitations. Allergic reactions best results. Before treating animals may occasionally occur. Treatment with long or matted hair, it may be should be discontinued if reactions are necessary to clip the affected area or severe. If new infections due to nonsen- spread the hairs to allow the medica- sitive bacteria or fungi appear during tion to contact the skin surface. Relief therapy, appropriate measures should may be noted following the first or sec- be taken. ond treatment; however, treatment [40 FR 13873, Mar. 27, 1975, as amended at 79 should not be discontinued too soon FR 10972, Feb. 27, 2014]

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§ 524.1742 N-(Mercaptomethyl) phthal- phosphate as necessary to maintain pH imide S-(O,O-dimethyl between 4.5 and 6.5. Stir well and re- phosphorodithioate) emulsifiable sume dipping. Repeat replenishment liquid. process as necessary. For evaportion, (a) Specifications. The emulsifiable add additional water accordingly. For liquid contains 11.6 percent N- added water due to rainfall, merely re- (mercaptomethyl) phthalimide S-(O,O- plenish dip with the product according dimethyl phosphorodithioate). to directions. If overflow occurs, either (b) Sponsor. See No. 000061 in analyze for drug concentration and ad- § 510.600(c) of this chapter. just accordingly or dispose of vat con- (c) Conditions of use—(1) Methods of tents and recharge. Check pH after application. Methods of application to each addition of water or super phos- control the following conditions on phate to assure proper pH controls. beef cattle: (b) Dip maintenance. (1) With use of Dilution rate dip vat tester, dipping may continue as To control/method of use (gal. drug: gal. of water) long as the drug concentration is maintained between 0.15 and 0.25 percent, Grubs: and the dip is not too foul for satisfac- Dip ...... 1:60 Pour-on ...... 1:2 tory use as indicated by foul odor or Spray ...... 1:49 excessive darkening (i.e., color changes Lice: Dip ...... 1:60 from beige to very dark brown). Pour-on ...... 1:2 or 1:5 (2) Without use of dip vat tester, vat Spray ...... 1:49 or 1:100 should be emptied, cleaned, and re- Hornflies: Dip ...... 1:60 charged each time one of the following Spray ...... 1:49 or 1:100 occurs: When the dip has been charged Cattle Ticks: for 120 days; when the dip becomes too Dip ...... 1:60 or 1:240 Spray ...... 1:49 foul for satisfactory use, within the Southern cattle ticks: 120-day limit; if the number of animals Dip ...... 1:60 or 1:240 Spray ...... 1:49 dipped equals twice the number of gal- Scabies mites:. lons of the initial dip volume, within Dip ...... 1:60 the 120-day limit. Lone Star Ticks: Dip ...... 1:60 (ii) Spray method. To prepare the Spray ...... 1:49 or 1:100 spray, mix drug with water according to table and stir thoroughly. Apply the (i) Dip vat procedure. (a) Prior to fresh mixture as a high-pressure spray, charging vat, empty old contents and taking care to wet the skin, not just thoroughly clean the vat. Dip vats the hair. Apply to the point of ‘‘run- should be calibrated to maintain an ac- off,’’ about 1 gallon of diluted spray per curate dilution. Add water, then drug adult animal. Lesser amounts will per- to the vat according to the dilution mit runoff for younger animals. rate indicated in the table. Add super phosphate at a rate of 100 pounds per (iii) Pour-on method. Dilute the drug 1,000 gallons of vat solution. Super with water according to table by slow- phosphate is added to control the pH of ly adding water to the product while the solution and ensure vat stability. stirring. Apply 1 ounce of the diluted Super phosphate is usually available at mixture per 100 pounds of body weight most fertilizer dealers as 0–45–0 or 0–46– (to a maximum of 8 ounces per head) 0. Stir the dip thoroughly, preferably down the center line of the back. with a compressed air device; however, (2) Timing of applications for cattle any form of thorough mixing is ade- grub control. For optimum cattle grub quate. Re-stir vat contents prior to control, it is important to treat as each use. During the dipping operation, soon as possible after the heel fly sea- each time the dip’s volume is reduced son, before the grub larvae reach the by 1⁄8 to 1⁄4 of its initial volume, replen- gullet or spinal canal, as the rapid kill ish with water and add the drug at a of large numbers of larvae in these tis- rate of 1 gallon for each 50 or 200 gal- sues may cause toxic side effects, such lons water added—depending on dilu- as bloat, salivation, staggering, and pa- tion rate 1:60 or 1:240. Also add super ralysis.

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(3) Treatment regimens. (i) Control of (b) Sponsor. See No. 054771 in scabies mites requires two treatments, § 510.600(c) of this chapter. 10 to 14 days apart. (c) Conditions of use in dogs and cats— (ii) Control of Lone Star Ticks and (1) Amount. It is administered as fol- hornflies requires two treatments, 7 lows: days apart. (i) For removal of sutures: Instill one (4) Warnings. The drug is a cholin- to two drops 2 or 3 minutes before re- esterase inhibitor. Do not use this drug moval of stitches. on animals simultaneously or within a (ii) For removal of foreign bodies few days before or after treatment with from eye, ear, and nose: For oph- or exposure to cholinesterase-inhib- thalmic use, instill three to five drops iting drugs, pesticides, or chemicals. in the eye prior to examination; for Do not apply within 21 days of slaugh- otic use, instill five to ten drops in the ter. For use on beef cattle only. Do not ear; for nasal use, instill five to ten treat sick, convalescent, or stressed drops in each nostril every 3 minutes cattle, or calves less than 3 months old for three doses. except in Federal or State eradication (iii) For tonometry: Instill one to programs where immediate treatment two drops immediately before measure- of all animals in an infested herd is ment. mandatory. Be sure free access to (iv) As an aid in treatment of otitis: drinking water is available to cattle Instill two drops into the ear every 5 prior to dipping. Do not dip excessively minutes for three doses. thirsty animals. Do not dip animals (v) For minor surgery: Instill one or when overheated. Repeat treatment as more drops as required. necessary but not more often than (vi) For catheterization: Instill two every 7 to 10 days. Treatment for lice, to three drops with a blunt 20-gauge ticks, hornflies, and scabies mites may needle immediately before inserting be made any time of the year except catheter. when cattle grub larvae are in the gul- (2) Indications for use. For use as a let or spinal canal. Treatment for lice, topical ophthalmic anesthetic. It is ticks, and scabies mites may be made used as an anesthetic in cauterization any time 7 to 10 days following treat- of corneal ulcers, removal of foreign ment for grubs. Do not treat grubs bodies and sutures from the cornea, when the grub larvae are in the gullet and measurement of intraocular pres- or spinal canal. Do not get in eyes, on sure (tonometry) when glaucoma is skin, or on clothing. Do not breathe suspected; as an aid in the removal of spray mist. Wear rubber gloves, gog- foreign bodies from the nose and ear gles, and protective clothing. In case of canal; as an accessory in the examina- skin contact, wash immediately with tion and treatment of painful otitis, in soap and water; for eyes, flush with minor surgery, and prior to catheter- water. Wash all contaminated clothing ization. with soap and hot water before re-use. (3) Limitations. Keep away from eyes (d) Related tolerances. See 40 CFR or other mucous membranes; avoid in- 180.261. haling; use with adequate ventilation; in case of deep or puncture wounds or [40 FR 13873, Mar. 27, 1975, as amended at 46 FR 27914, May 22, 1981; 48 FR 39607, Sept. 1, serious burns, consult a veterinarian. 1983; 54 FR 51021, Dec. 12, 1989; 61 FR 8873, (d) Conditions of use. (1) The drug is Mar. 6, 1996; 62 FR 61626, Nov. 19, 1997; 63 FR indicated for use as a topical oph- 5255, Feb. 2, 1998] thalmic anesthetic in animals. It is used as an anesthetic in cauterization § 524.1982 Proparacaine ophthalmic of corneal ulcers, removal of foreign solution. bodies and sutures from the cornea, (a) Specifications. The drug is an aque- and measurement of intraocular pres- ous solution containing 0.5 percent sure (tonometry) when glaucoma is proparacaine hydrochloride, 2.45 per- suspected. Local applications may also cent glycerin as a stabilizer, and 0.2 be used as an aid in the removal of for- percent chlorobutanol (choral deriva- eign bodies from the nose and ear tive) and 1:10,000 benzalkonium chlo- canal, as an accessory in the examina- ride as preservatives. tion and treatment of painful otitis, in

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minor surgery, and prior to catheter- weeks of age and older, and cats 8 ization. weeks of age and older. (2) It is administered as follows: (3) Limitations. Federal law restricts (i) For removal of sutures: Instill one this drug to use by or on the order of a to two drops 2 or 3 minutes before re- licensed veterinarian. moval of stitches. (ii) For removal of foreign bodies [64 FR 37401, July 12, 1999, as amended at 64 from eye, ear, and nose: For oph- FR 48707, Sept. 8, 1999; 65 FR 45282, July 21, 2000; 74 FR 19878, Apr. 30, 2009; 79 FR 10972, thalmic use, instill three to five drops Feb. 27, 2014] in the eye prior to examination; for otic use, instill five to 10 drops in the § 524.2101 Selenium disulfide suspen- ear; for nasal use, instill five to 10 sion. drops in each nostril every 3 minutes (a) Specifications. The product con- for three doses. tains 0.9-percent weight in weight (w/w) (iii) For tonometry: Instill one to selenium disulfide (1-percent weight in two drops immediately before measure- volume (w/v)). ment. (iv) As an aid in treatment of otitis: (b) Sponsors. See Nos. 000061, 017135, Instill two drops into the ear every 5 and 050604 in § 510.600(c) of this chapter. minutes for three doses. (c) Conditions of use on dogs—(1) Indi- (v) For minor surgery: Instill one or cations for use. For use as a cleansing more drops as required. shampoo and as an agent for removing (vi) For catheterization: Instill two skin debris associated with dry eczema, to three drops with a blunt 20-gauge seborrhea, and nonspecific dermatoses. needle immediately before inserting (2) Amount. One to 2 ounces per appli- catheter. cation. (3) For use only by or on the order of (3) Limitations. Use carefully around a licensed veterinarian. scrotum and eyes, covering scrotum with petrolatum. Allow the shampoo to [40 FR 13873, Mar. 27, 1975, as amended at 50 FR 41490, Oct. 11, 1985; 79 FR 10972, Feb. 27, remain for 5 to 15 minutes before thor- 2014] ough rinsing. Repeat treatment once or twice a week. If conditions persist or if § 524.2098 Selamectin. rash or irritation develops, discontinue (a) Specifications. Each milliliter con- use and consult a veterinarian. tains 60 or 120 milligrams of [47 FR 53351, Nov. 26, 1982, as amended at 48 selamectin. FR 32762, July 19, 1983; 54 FR 36962, Sept. 6, (b) Sponsor. See 054771 in § 510.600(c) of 1989; 56 FR 9623, Mar. 7, 1991; 58 FR 41025, this chapter. Aug. 2, 1993; 63 FR 26981, May 15, 1998; 70 FR (c) [Reserved] 50183, Aug. 26, 2005] (d) Conditions of use—(1) Amount. 2.7 milligrams of selamectin, topically, § 524.2350 Tolnaftate cream. per pound (6 milligrams per kilogram) (a) Specifications. The drug contains 1 of body weight. percent tolnaftate in an anhydrous (2) Indications for use. Kills adult fleas cream base. and prevents flea eggs from hatching (b) Sponsor. See No. 000061 in for 1 month, and it is indicated for the § 510.600(c) of this chapter. prevention and control of flea infesta- (c) Conditions of use—(1) Amount. tions (Ctenocephalides felis), prevention Apply a small amount of the cream to of heartworm disease caused by the affected areas once or twice a day Dirofilaria immitis, and treatment and for 2 to 4 weeks. control of ear mite (Otodectes cynotis) (2) Indications for use. For the treat- infestations in dogs and cats. Treat- ment of ringworm lesions due to ment and control of sarcoptic mange Microsporum canis and Microsporum (Sarcoptes scabiei) and control of tick gypseum. (Dermacentor variabilis) infestations in (3) Limitations. Federal law restricts dogs. Treatment and control of intes- this drug to use by or on the order of a tinal hookworm (Ancylostoma licensed veterinarian. tubaeforme) and roundworm (Toxocara cati) infections in cats. For dogs 6 [79 FR 10972, Feb. 27, 2014]

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§ 524.2482 Triamcinolone spray. (1) No. 051079 for use of product described in paragraph (a)(1). (a) Specifications. Each milliliter of (2) No. 017135 for use of product de- solution contains 0.15 milligrams scribed in paragraph (a)(2). triamcinolone acetonide. (c) Conditions of use—(1) Amount. (b) Sponsor. See No. 051311 in Apply directly to the wound site. § 510.600(c) of this chapter. (2) Indications for use. As an aid in the (c) Conditions of use in dogs—(1) treatment of external wounds and as- Amount. Apply sufficient pump sprays sists healing by facilitating the re- to uniformly and thoroughly wet the moval of necrotic tissue, exudate, and affected areas while avoiding run off of organic debris. excess product. Administer twice daily for 7 days, then once daily for 7 days, [79 FR 10973, Feb. 27, 2014] then every other day for an additional 14 days (28 days total). PART 526—INTRAMAMMARY DOS- (2) Indications for use. For the control AGE FORM NEW ANIMAL of pruritus associated with allergic der- DRUGS matitis. (3) Limitations. Federal law restricts Sec. this drug to use by or on the order of a 526.88 Amoxicillin trihydrate for licensed veterinarian. intramammary infusion. 526.313 Ceftiofur. [68 FR 4916, Jan. 31, 2003, as amended at 78 526.363 Cephapirin benzathine. FR 17868, Mar. 25, 2013] 526.365 Cephapirin sodium. 526.464 Cloxacillin intramammary dosage § 524.2483 Triamcinolone cream. forms. 526.464a Cloxacillin benzathine. (a) Specifications. The vanishing 526.464b Cloxacillin benzathine for cream contains 0.1 percent intramammary infusion, sterile. triamcinolone acetonide. 526.464c Cloxacillin sodium for (b) Sponsor. See Nos. 000010 and 054925 intramammary infusion, sterile. in § 510.600(c) of this chapter. 526.820 Erythromycin. (c) Conditions of use in dogs—(1) 526.1130 Hetacillin infusion. Amount. Rub into affected areas two to 526.1590 Novobiocin infusion. 526.1696 Penicillin intramammary dosage four times daily for 4 to 10 days. forms. (2) Indications for use. For topical 526.1696a Penicillin G procaine. treatment of allergic dermatitis and 526.1696b Penicillin G procaine-dihydro- summer eczema. streptomycin in soybean oil for (3) Limitations. Federal law restricts intramammary infusion (dry cows). this drug to use by or on the order of a 526.1696c Penicillin G procaine-dihydrostreptomycin sulfate for intramammary licensed veterinarian. infusion (dry cows). [71 FR 13542, Mar. 16, 2006, as amended at 73 526.1696d Penicillin G procaine-novobiocin FR 79318, Dec. 29, 2008. Redesignated and for intramammary infusion. amended at 75 FR 10168, Mar. 5, 2010; 77 FR 526.1810 Pirlimycin. 60302, Oct. 3, 2012] AUTHORITY: 21 U.S.C. 360b.

§ 524.2620 Liquid crystalline trypsin, § 526.88 Amoxicillin trihydrate for Peru balsam, castor oil. intramammary infusion. (a) Specifications—(1) Each gram of (a) Specifications. Each single dose sy- liquid or aerosol contains 0.12 milli- ringe contains amoxicillin trihydrate gram of crystalline trypsin, 87.0 milli- equivalent to 62.5 milligrams of grams of Peru balsam, and 788.0 milli- amoxicillin. grams of castor oil. (b) Sponsor. See No. 000061 in (2) Each gram of liquid or aerosol § 510.600(c) of this chapter. contains 0.1 milligram of crystalline (c) Related tolerances. See § 556.38 of trypsin, 72.5 milligrams of Peru bal- this chapter. sam, and 800 milligrams of castor oil. (d) Conditions of use—Lactating cows— (b) Sponsors. See sponsor numbers in (1) Amount. One syringe (equivalent to § 510.600(c) of this chapter for use as in 62.5 milligrams amoxicillin) per quar- paragraph (c) in this section: ter.

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(2) Indications for use. For the treat- vention purposes; at unapproved doses; ment of subclinical infectious bovine frequencies, durations, or routes of ad- mastitis due to Streptococcus agalactiae ministration; and in unapproved major and Straphylococcus aureus (penicillin food producing species/production sensitive). classes. (3) Limitations. Administer after (2) Dry cows—(i) Amount. Infuse 500 milking. Clean and disinfect the teat. mg per affected quarter at the time of Use one syringe per infected quarter dry off. every 12 hours for a maximum of 3 (ii) Indications for use. For the treat- doses. Do not use milk taken from ment of subclinical mastitis in dairy treated animals for food purposes with- cattle at the time of dry off associated in 60 hours (5 milkings) after last treat- with Staphylococcus aureus, Strepto- ment. Do not slaughter treated ani- coccus dysgalactiae, and Streptococcus mals for food purposes within 12 days uberis. after the last treatment. Federal law (iii) Limitations. Milk taken from restricts this drug to use by or on the cows completing a 30-day dry-off period order of a licensed veterinarian. may be used for food with no milk dis- [57 FR 37334, Aug. 18, 1992, as amended at 60 card due to ceftiofur residues. Fol- FR 55660, Nov. 2, 1995; 68 FR 44878, July 31, lowing intramammary infusion, a 16- 2003] day preslaughter withdrawal period is required for treated cows. Following § 526.313 Ceftiofur. label use, no preslaughter withdrawal (a) Specifications. Each single-use, 10- period is required for neonatal calves milliliter syringe of ceftiofur hydro- from treated cows regardless of colos- chloride suspension contains 125 milli- trum consumption. Federal law re- grams (mg) or 500 mg ceftiofur equiva- stricts this drug to use by or on the lents. order of a licensed veterinarian. Fed- (b) Sponsor. See No. 054771 in eral law prohibits extra-label use of § 510.600(c) of this chapter. this drug in dry dairy cattle for disease (c) Related tolerances. See § 556.113 of prevention purposes; at unapproved this chapter. doses; frequencies, durations, or routes (d) Conditions of use in cattle—(1) Lac- of administration; and in unapproved tating cows—(i) Amount. Infuse 125 mg major food producing species/produc- per affected quarter. Repeat treatment tion classes. in 24 hours. Once daily treatment may be repeated for up to 8 consecutive [70 FR 9516, Feb. 28, 2005, as amended at 70 days. FR 20048, Apr. 18, 2005. Redesignated and amended at 71 FR 39545, July 13, 2006; 79 FR (ii) Indications for use. For use in lac- 10973, Feb. 27, 2013; 79 FR 18159, Apr. 1, 2014; tating dairy cattle: 80 FR 34279, June 16, 2015] (A) For the treatment of clinical mastitis associated with coagulase- § 526.363 Cephapirin benzathine. negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli; and (a) Specifications. Each 10 milliliter (B) For the treatment of diagnosed disposable syringe contains 300 milli- subclinical mastitis associated with grams of cephapirin activity (as coagulase-negative staphylococci and cephapirin benzathine) in a peanut-oil S. dysgalactiae. gel. (iii) Limitations. Milk taken from (b) Sponsor. See No. 000010 in cows during treatment (a maximum of § 510.600(c) of this chapter. eight daily infusions) and for 72 hours (c) Related tolerances. See § 556.115 of after the last treatment must not be this chapter. used for human consumption. Fol- (d) Conditions of use—(1) Amount. In- lowing label use for up to 8 consecutive fuse the contents of one syringe into days, a 2-day preslaughter withdrawal each quarter. period is required. Federal law restricts (2) Indications for use. Use in dry cows this drug to use by or on the order of a for treatment of mastitis caused by licensed veterinarian. Federal law pro- susceptible strains of Streptococcus hibits extra-label use of this drug in agalactiae and Staphylococcus aureus, lactating dairy cattle for disease pre- including penicillin-resistant strains.

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(3) Limitations. Infuse each quarter (c) Sponsor. See No. 000010 in following last milking, but no later § 510.600(c) of this chapter for use in than 30 days before calving. Milk from dairy cows. treated cows must not be used for food (1) Amount. Administer aseptically during the first 72 hours after calving. into each quarter immediately after Animals infused with this product last milking. must not be slaughtered for food until (2) Indications for use. For the treat- 42 days after the latest infusion. For ment of mastitis caused by Staphy- use in dry cows only. lococcus aureus and Streptococcus [43 FR 37174, Aug. 22, 1978, as amended at 53 agalactiae including penicillin resistant FR 27851, July 25, 1988; 73 FR 12262, Mar. 7, strains in dairy cows during the dry pe- 2008; 75 FR 10168, Mar. 5, 2010; 76 FR 17338, riod. Mar. 29, 2011] (3) Limitations. For use in dry cows only. Not to be used within 30 days of § 526.365 Cephapirin sodium. calving. Animals infused with this (a) Specifications. Each 10-milliliter product must not be slaughtered for dose contains 200 milligrams of food use for 30 days after the latest in- cephapirin sodium activity in a peanut- fusion. Federal law restricts this drug oil gel. to use by or on the order of a licensed (b) Sponsor. See No. 000010 in veterinarian. § 510.600(c) of this chapter. (c) Related tolerances. See § 556.115 of [57 FR 37334, Aug. 18, 1992; 57 FR 42623, Sept. this chapter. 15, 1992, as amended at 60 FR 55660, Nov. 2, (d) Conditions of use in lactating 1995; 75 FR 10168, Mar. 5, 2010; 75 FR 71017, cows—(1) Amount. Infuse one dose into Nov. 22, 2010; 79 FR 10973, Feb. 27, 2014] each infected quarter immediately after the quarter has been completely § 526.464b Cloxacillin benzathine for intramammary infusion, sterile. milked out. Do not milk out for 12 hours. Repeat once only in 12 hours. (a) Specifications. Each 6 milliliter (2) Indications for use. For the treat- dose contains cloxacillin benzathine ment of mastitis in lactating cows equivalent to 500 milligrams of caused by susceptible strains of Strepto- cloxacillin. coccus agalactiae and Staphylococcus (b) Related tolerances. See § 556.165 of aureus including strains resistant to this chapter. penicillin. (c) Sponsor. See No. 055529 in (3) Limitations. If improvement is not § 510.600(c) of this chapter. noted within 48 hours after treatment, (1) Amount. 6 milliliters per infected consult your veterinarian. Milk that quarter aseptically immediately after has been taken from animals during last milking at the time of drying-off treatment and for 96 hours after the of the cow. last treatment must not be used for (2) Indications for use. Treatment of food. Treated animals must not be mastitis caused by Staphylococcus slaughtered for food until 4 days after aureus and Streptococus agalactiae in the last treatment. dairy cows at the time of drying-off of [40 FR 57455, Dec. 10, 1975, as amended at 53 the cow. FR 27852, July 25, 1988. Redesignated at 63 FR (3) Limitations. For use in dry cows 8349, Feb. 19, 1998; 65 FR 20733, Apr. 18, 2000; only. Not to be used within 30 days of 73 FR 3181, Jan. 17, 2008; 75 FR 10168, Mar. 5, calving. Milk taken from treated cows 2010] prior to 72 hours (6 milkings) after § 526.464 Cloxacillin intramammary calving must not be used for human dosage forms. food. Animals infused with this product must not be slaughtered for food from § 526.464a Cloxacillin benzathine. the time of infusion until 72 hours after (a) Specifications. Each dose contains calving. Federal law restricts this drug cloxacillin benzathine equivalent to 500 to use by or on the order of a licensed milligrams of cloxacillin. veterinarian. (b) Related tolerances. See § 556.165 of (d) Sponsor. See No. 000061 in this chapter. § 510.600(c) of this chapter.

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(1) Amount. One dose per infected butylated hydroxyanisole, and 0.45 mil- quarter immediately after last milk- ligram of butylated hydroxytoluene. ing. (2) Each 12-milliliter, single-dose, dis- (2) Indications for use. Treatment and posable syringe contains 600 milligrams prophylaxis of bovine mastitis in non- of erythromycin (as the base), 0.90 mil- lactating cows due to Streptococcus ligram of butylated hydroxyanisole, agalactiae and Staphylococcus aureus. and 0.90 milligram of butylated hy- (3) Limitations. For use in dry cows droxytoluene. only. Not to be used within 4 weeks (28 (3) The vehicle is triglyceride of satu- days) of calving. Animals infused with rated fatty acids from coconut oil. this product must not be slaughtered (4) The drug may or may not be ster- for food use for 4 weeks (28 days) after ile. the latest infusion. Federal law re- (b) Sponsor. See Nos. 054771 and 061623 stricts this drug to use by or on the in § 510.600(c) of this chapter. order of a licensed veterinarian. (c) Conditions of use—(1) Amount. (i) [57 FR 37334, Aug. 18, 1992; 57 FR 42623, Sept. Lactating cows: After milking, clean- 15, 1992, as amended at 58 FR 61016, Nov. 19, ing, and disinfecting, infuse contents of 1993; 60 FR 55660, Nov. 2, 1995; 68 FR 44878, a single 6-milliliter syringe into each July 31, 2003] infected quarter; repeat procedure at 12-hour intervals for a maximum of 3 § 526.464c Cloxacillin sodium for consecutive infusions. intramammary infusion, sterile. (ii) Dry cows: After milking, clean- (a) Specifications. Each milliliter con- ing, and disinfecting, infuse contents of tains cloxacillin sodium equivalent to a single 12-milliliter syringe into each 20.0 milligrams of cloxacillin. infected quarter at the time of drying (b) Sponsor. See No. 000061 in off. § 510.600(c) of this chapter. (2) Indications for use. Treatment of (c) Related tolerances. See § 556.165 of mastitis due to Staphylococcus aureus, this chapter. Streptococcus agalactiae, Streptococcus (d) Conditions of use. Lactating cows— dysgalactiae, and Streptococcus uberis in (1) Amount. 10 milliliters (one dose of lactating or dry cows. 200 milligrams) per infected quarter. (3) Limitations. Milk taken from ani- (2) Indications for use. Treatment of mals during treatment and for 36 hours mastitis in lactating cows due to Strep- (3 milkings) after the latest treatment tococcus agalactiae and Staphylococcus must not be used for food. aureus, nonpenicillinase-producing [47 FR 15772, Apr. 13, 1982, as amended at 66 strains. FR 14074, Mar. 9, 2001; 68 FR 4915, Jan. 31, (3) Limitations. Administer after 2003; 79 FR 10973, Feb. 27, 2014] milking, cleaning, and disinfecting, and as early as possible after detection. § 526.1130 Hetacillin infusion. Treatment should be repeated at 12- (a) Specifications. Each 10 milliliter hour intervals for a total of three syringe contains hetacillin potassium doses. Milk taken from treated animals equivalent of 62.5 milligrams of ampi- within 48 hours (four milkings) after cillin. the latest treatment should not be used (b) Sponsor. See No. 000010 in for food. Treated animals should not be § 510.600(c) of this chapter. slaughtered for food within 10 days (c) Conditions of use. Lactating cows— after the latest treatment. Federal law (1) Amount. 10 milliliters of hetacillin restricts this drug to use by or on the potassium equivalent to 62.5 milli- order of a licensed veterinarian. grams ampicillin into each infected [57 FR 37335, Aug. 18, 1992, as amended at 60 quarter. Repeat at 24-hour intervals FR 55660, Nov. 2, 1995; 68 FR 44878, July 31, until a maximum of three treatments 2003] has been given. (2) Indications for use. Treating acute, § 526.820 Erythromycin. chronic, or subclinical bovine mastitis (a) Specifications. (1) Each 6-milliliter, in lactating cows caused by susceptible single-dose, disposable syringe con- strains of Streptococcus agalactiae, tains 300 milligrams of erythromycin Streptococcus dysgalactiae, Staphy- (as the base), 0.45 milligram of lococcus aureus, and Escherichia coli.

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(3) Limitations. Milk that has been taken from treated animals within 72 taken from animals during treatment hours (6 milkings) after latest treat- and for 72 hours (6 milkings) after the ment must not be used for food. Do not latest treatment must not be used for slaughter treated animals for food for food. Treated animals must not be 15 days following latest treatment. If slaughtered for food until 10 days after redness, swelling, or abnormal milk the latest treatment. Federal law re- persists or increases after treatment, stricts this drug to use by or on the discontinue use and consult a veteri- order of a licensed veterinarian. narian. For udder instillation in lactating cattle only. Federal law re- [57 FR 37335, Aug. 18, 1992, as amended at 75 FR 10168, Mar. 5, 2010] stricts this drug to use by or on the order of a licensed veterinarian. § 526.1590 Novobiocin infusion. [43 FR 10554, Mar. 14, 1978, as amended at 79 (a)(1) Specifications. Each 10 milli- FR 10973, Feb. 27, 2014] liters of oil suspension contains the equivalent of 400 milligrams of § 526.1696 Penicillin intramammary novobiocin (present as sodium dosage forms. novobiocin). § 526.1696a Penicillin G procaine. (2) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (a) Specifications. Each 10-milliliter (3) Related tolerances. See § 556.460 of single-dose syringe contains penicillin this chapter. G procaine equivalent to 100,000 units (4) Conditions of use—(i) Amount. Ten of penicillin G. milliliters (equivalent to 400 milli- (b) Related tolerances. See § 556.510 of grams of novobiocin) infused in each this chapter. quarter. (c) Sponsors. See Nos. 010515 and (ii) Indications for use. It is used in 061623 in § 510.600(c) of this chapter. dry cows for the treatment of mastitis (d) Conditions of use in lactating caused by susceptible strains of Staphy- cows—(1) Amount. Infuse one 10-milli- lococcus aureus and Streptococcus liter dose into each infected quarter. agalactiae. Treatment may be repeated at 12-hour (iii) Limitations. Infuse each quarter intervals for not more than three at the time of drying off, but not less doses, as indicated by clinical response. than 30 days prior to calving. Do not (2) Indications for use. For the treat- slaughter treated animals for food use ment of mastitis caused by Strepto- for 30 days following udder infusion. coccus agalactiae, S. dysgalactiae, and S. For udder installation for the treat- uberus in lactating cows. ment of mastitis in dry cows only. (3) Limitations. Milk that has been (b)(1) Specifications. Each 10 milli- taken from animals during treatment liters of oil suspension contains the and for 60 hours after the latest treat- equivalent of 150 milligrams of ment must not be used for food. Ani- novobiocin (present as sodium mals must not be slaughtered for food novobiocin). during treatment or within 3 days after (2) Sponsor. See No. 054771 in the latest treatment. § 510.600(c) of this chapter. (e) Conditions of use in dry cows—(1) (3) Related tolerances. See § 556.460 of Amount. Infuse one 10-milliliter dose this chapter. into each infected quarter at time of (4) Conditions of use—(i) Amount. In- drying-off. fuse 10 milliliters (equivalent to 150 (2) Indications of use. For the treat- milligrams of novobiocin) in each quar- ment of mastitis caused by Strepto- ter after milking. Repeat treatment coccus agalactiae in dry cows. once after 24 hours. (3) Limitations. Discard all milk for 72 (ii) Indications for use. Use in lac- hours (6 milkings) following calving, or tating cows for treatment of mastitis later as indicated by the marketable caused by susceptible strains of Staphy- quality of the milk. Animals must not lococcus aureus. be slaughtered for food within 14 days (iii) Limitations. Do not milk for at postinfusion. least 6 hours after treatment; after- [73 FR 18442, Apr. 4, 2008, as amended at 74 wards, milk at regular intervals. Milk FR 18990, Apr. 27, 2009]

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§ 526.1696b Penicillin G procaine-dihy- be slaughtered for food within 60 days drostreptomycin in soybean oil for from the time of infusion nor within 96 intramammary infusion (dry cows). hours after calving. Federal law re- (a) Specifications. Each 10 milliliters stricts this drug to use by or on the of suspension contains penicillin G pro- order of a licensed veterinarian. caine equivalent to 200,000 units of pen- [57 FR 37336, Aug. 18, 1992; 57 FR 42623, Sept. icillin G and dihydrostreptomycin sul- 15, 1992; 79 FR 10965, Feb. 27, 2014] fate equivalent to 300 milligrams of dihydrostreptomycin. § 526.1696d Penicillin G procaine- (b) Sponsor. See No. 054628 in novobiocin for intramammary infu- § 510.600(c) of this chapter. sion. (c) Related tolerances. See §§ 556.200 and 556.510 of this chapter. (a) Specifications. For lactating cat- (d) Conditions of use. Dairy cows—(1) tle: each 10-milliliter dose contains Amount. One syringe into each quarter 100,000 units of penicillin G procaine at the last milking prior to drying off. and 150 milligrams of novobiocin as (2) Indications for use. Intramammary novobiocin sodium. For dry cows: treatment of subclinical mastitis in 200,000 units of penicillin G procaine dairy cows at the time of drying off, and 400 milligrams of novobiocin as specifically against infections caused novobiocin sodium. by Staphylococcus aureus and Strepto- (b) Sponsor. See No. 054771 in coccus agalactiae. § 510.600(c) of this chapter. (3) Limitations. Not to be used within (c) Conditions of use—(1) Lactating 6 weeks of calving. For use in dry cows cows—(i) Amount. 10 milliliters in each only. Milk taken from cows within 24 infected quarter after milking. Repeat hours (2 milkings) after calving must once after 24 hours. not be used for food. Animals infused (ii) Indications for use. Treating lac- with this drug must not be slaughtered tating cows for mastitis caused by sus- for food within 60 days of treatment ceptible strains of Staphylococcus nor within 24 hours after calving. aureus, Streptococcus agalactiae, Strepto- [57 FR 37336, Aug. 18, 1992, as amended at 78 coccus dysgalactiae, and Streptococcus FR 21060, Apr. 9, 2013] uberis. (iii) Limitations. For udder instilla- § 526.1696c Penicillin G procaine-dihy- tion in lactating cattle only. Do not drostreptomycin sulfate for milk for at least 6 hours after treat- intramammary infusion (dry cows). ment; thereafter, milk at regular inter- (a) Specifications. Each 10 milliliters vals. Milk taken from treated animals of suspension contains penicillin G pro- within 72 hours (6 milkings) after the caine equivalent to 1 million units of latest treatment must not be used for penicillin G and dihydrostreptomycin food. Treated animals must not be sulfate equivalent to 1 gram of dihy- slaughtered for food for 15 days fol- drostreptomycin. lowing the latest treatment. If redness, (b) Sponsor. See No. 042791 in swelling, or abnormal milk persists, § 510.600(c) of this chapter. discontinue use and consult a veteri- (c) Related tolerances. See §§ 556.200 narian. and 556.510 of this chapter. (d) Conditions of use. Dairy cows—(1) (2) Dry cows—(i) Amount. 10 milli- Amount. One syringe per quarter at the liters in each quarter at time of drying last milking prior to drying off. off. (2) Indications for use. Intramammary (ii) Indications for use. Treatment of use to reduce the frequency of existing subclinical mastitis caused by suscep- infection and to prevent new infections tible strains of Staphylococcus aureus with Staphylococcus aureus in dry cows. and Streptococcus agalactiae. (3) Limitations. Not to be used within (iii) Limitations. For udder instilla- 6 weeks of freshening. Not for use in tion in dry cows only. Do not use less lactating cows. Milk taken from ani- than 30 days prior to calving. Milk mals within 96 hours (8 milkings) after from treated cows must not be used for calving must not be used for feed. Ani- food during the first 72 hours after mals infused with this drug must not calving. Treated animals must not be

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slaughtered for food for 30 days fol- SOURCE: 74 FR 6823, Feb. 11, 2009, unless lowing udder infusion. otherwise noted. [57 FR 37336, Aug. 18, 1992; 57 FR 42623, Sept. § 528.1070 Bc6 recombinant 15, 1992; 79 FR 10973, Feb. 27, 2014] deoxyribonucleic acid construct. § 526.1810 Pirlimycin. (a) Specifications and indications for use. Five copies of a human Bc6 recom- (a) Specifications. Each 10-milliliter binant deoxyribonucleic acid (rDNA) syringe contains 50 milligrams (mg) construct located at the GTC 155–92 pirlimycin (as pirlimycin hydro- site in a specific hemizygous diploid chloride). line of dairy breeds of domestic goats (b) Sponsor. See No. 054771 in (Capra aegagrus hircus) directing the § 510.600(c) of this chapter. expression of the human gene for (c) Related tolerances. See § 556.515 of antithrombin (which is intended for this chapter. the treatment of humans) in the mam- (d) Conditions of use in cattle—(1) mary gland of goats derived from lin- Amount. Infuse 50 mg into each infected eage progenitor 155–92. quarter. Repeat treatment after 24 (b) Sponsor. See No. 086047 in § 510.600 hours. Daily treatment may be re- of this chapter. peated at 24-hour intervals for up to 8 (c) Limitations. Food or feed from consecutive days. GTC–155–92 goats is not permitted in (2) Indications for use. For the treat- the food or feed supply. ment of clinical and subclinical mastitis in lactating dairy cattle associ- [74 FR 6823, Feb. 11, 2009, as amended at 80 ated with Staphylococcus species such FR 34279, June 16, 2015] as Staphylococcus aureus and Strepto- § 528.1092 opAFP–GHc2 recombinant coccus species such as Streptococcus deoxyribonucleic acid construct. agalactiae, Streptococcus dysgalactiae, and Streptococcus uberis. (a) Specifications. A single copy of the (3) Limitations. Milk taken from ani- a-form of the opAFP–GHc2 recombinant mals during treatment and for 36 hours deoxyribonucleic acid (rDNA) con- following the last treatment must not struct at the a-locus in the EO–1 a lin- be used for food regardless of treat- eage of triploid, hemizygous, all-female ment duration. Following infusion Atlantic salmon (Salmo salar). twice at a 24-hour interval, treated ani- (b) Sponsor. See No. 086053 in § 510.600 mals must not be slaughtered for 9 of this chapter. days. Following any extended duration (c) Indications for use. Significantly of therapy (infusion longer than twice more of these Atlantic salmon grow to at a 24-hour interval, up to 8 consecu- at least 100 grams within 2,700 Celsius tive days), animals must not be slaugh- degree-days than their comparators. tered for 21 days. Federal law restricts (d) Limitations. These Atlantic salm- this drug to use by or on the order of a on are produced as eyed-eggs and licensed veterinarian. grown-out only in physically-contained, freshwater culture facilities [58 FR 58486, Nov. 2, 1993, as amended at 65 specified in an FDA-approved applica- FR 61091, Oct. 16, 2000; 73 FR 811, Jan. 4, 2008; 79 FR 10973, Feb. 27, 2014] tion. [80 FR 73104, Nov. 24, 2015] PART 528—NEW ANIMAL DRUGS IN § 528.2010 Human lysosomal acid GENETICALLY ENGINEERED ANI- lipase recombinant MALS deoxyribonucleic acid construct. (a) Specifications. A single copy of a Sec. 528.1070 Bc6 recombinant deoxyribonucleic human lysosomal acid lipase (hLAL) acid construct. recombinant deoxyribonucleic acid 528.1092 opAFP–GHc2 recombinant (rDNA) gene construct located at the deoxyribonucleic acid construct. SYN LAL–C site in chromosome 6 in a 528.2010 Human lysosomal acid lipase re- specific, diploid line (SBC LAL–C) of combinant deoxyribonucleic acid con- hemizygous and homozygous domestic struct. chickens (Gallus gallus), derived from AUTHORITY: 21 U.S.C. 360b. the lineage progenitor XLL 109.

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(b) Sponsor. See No. 069334 in § 510.600 albuterol sulfate. One dose is three (3) of this chapter. puffs, totaling 360 mcg. (c) Conditions of use—(1) Intended use. (2) Indications for use. For the imme- The gene construct directs the expres- diate relief of bronchospasm and sion of that encoding gene such that bronchoconstriction associated with recombinant, human lysosomal acid reversible airway obstruction in lipase (rhLAL) protein intended for the horses. treatment of human disease is present (3) Not for use in horses intended for in SBC LAL–C chicken egg whites. food. Federal law restricts this drug to (2) Limitations. Food or feed from use by or on the order of a licensed vet- XLL 109 chickens is not permitted in erinarian. the food or feed supply. [67 FR 7072, Feb. 15, 2002, as amended at 79 [81 FR 17608, Mar. 30, 2016] FR 10973, Feb. 27 , 2014]

PART 529—CERTAIN OTHER DOS- § 529.56 Amikacin. AGE FORM NEW ANIMAL (a) Specifications. Each milliliter DRUGS (mL) of solution contains 250 milligrams of amikacin as amikacin sulfate. Sec. (b) Sponsors. See Nos. 000859 and 529.40 Albuterol. 054771 in § 510.600(c) of this chapter. 529.56 Amikacin. (c) Conditions of use in horses—(1) 529.382 Chloramine-T. Amount. Administer 2 grams (8 mL) di- 529.400 Chlorhexidine tablets and suspen- luted with 200 mL of sterile physio- sion. 529.536 Detomidine. logical saline by intrauterine infusion 529.539 Dexmedetomidine. daily for 3 consecutive days. 529.778 Doxycycline. (2) Indications for use. For treating 529.1030 Formalin. genital tract infections (endometritis, 529.1044 Gentamicin in certain other dosage metritis, and pyometra) in mares forms. caused by susceptible organisms in- 529.1044a Gentamicin solution for infusion. cluding Escherichia coli, Pseudomonas 529.1044b Gentamicin solution for dipping eggs. spp., and Klebsiella spp. 529.1115 Halothane. (3) Limitations. Do not use in horses 529.1150 Hydrogen peroxide. intended for human consumption. Fed- 529.1186 Isoflurane. eral law restricts this drug to use by or 529.1350 Meloxicam. on the order of a licensed veterinarian. 529.1660 Oxytetracycline. 529.1940 Progesterone intravaginal inserts. [76 FR 17339, Mar. 29, 2011, as amended at 78 529.2150 Sevoflurane. FR 17597, Mar. 22, 2013; 79 FR 10973, Feb. 27, 529.2464 Ticarcillin. 2014] 529.2503 Tricaine methanesulfonate. 529.2620 Triptorelin. § 529.382 Chloramine-T. AUTHORITY: 21 U.S.C. 360b. (a) Specifications. Chloramine-T tri- SOURCE: 40 FR 13881, Mar. 27, 1975, unless hydrate powder for solution. otherwise noted. (b) Sponsor. See No. 086009 in § 510.600(c) of this chapter. § 529.40 Albuterol. (c) Related tolerances. See § 556.118 of (a) Specifications. A net weight of 6.7 this chapter. grams of formulated albuterol sulfate (d) Conditions of use—(1) Freshwater- is supplied in a pressurized aluminum reared salmonids—(i) Amount. 12 to 20 canister within an actuator system milligrams per liter (mg/L) water in a equipped with a detachable nasal deliv- continuous flow water supply or as a ery bulb. static bath once per day for 60 minutes (b) Approvals. See No. 000010 in on consecutive or alternative days for § 510.600(c) of this chapter for uses as in three treatments. paragraph (d) of this section. (ii) Indications for use. For the control (c) Conditions of use—(1) Amount. of mortality in freshwater-reared Each valve actuation (puff) of the de- salmonids due to bacterial gill disease vice delivers 120 micrograms (mcg) of associated with Flavobacterium spp.

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(2) Walleye—(i) Amount. 10 to 20 mg/L § 529.536 Detomidine. water in a continuous flow water sup- (a) Specifications. Each milliliter of ply or as a static bath once per day for gel contains 7.6 milligrams (mg) of 60 minutes on consecutive or alter- detomidine hydrochloride. native days for three treatments. (b) Sponsor. See No. 052483 in (ii) Indications for use. For the control § 510.600(c) of this chapter. of mortality in walleye due to external (c) Conditions of use in horses—(1) columnaris disease associated with Amount. Administer 0.018 mg per pound Flavobacterium columnare. (mg/lb) (0.040 mg/kilogram (kg) sublin- (3) Freshwater-reared warmwater gually. finfish—(i) Amount. 20 mg/L water in a (2) Indications for use. For sedation continuous flow water supply or as a and restraint. static bath once per day for 60 minutes (3) Limitations. Federal law restricts on consecutive or alternative days for this drug to use by or on the order of a three treatments. licensed veterinarian. Do not use in (ii) Indications for use. For the control horses intended for human consump- of mortality in freshwater-reared tion. warmwater finfish due to external columnaris disease associated with F. [75 FR 21163, Apr. 23, 2010, as amended at 76 columnare. FR 16533, Mar. 24, 2011] [79 FR 37621, July 2, 2014] § 529.539 Dexmedetomidine. (a) Specifications. Each milliliter of § 529.400 Chlorhexidine tablets and suspension. gel contains 0.09 milligrams (mg) dexmedetomidine (equivalent to 0.1 mg (a) Specification. Each tablet and each dexmedetomidine hydrochloride). 28-milliliter syringe of suspension con- (b) Sponsor. See No. 052483 in tain 1 gram of chlorhexidine § 510.600(c) of this chapter. dihydrochloride. (c) Conditions of use—(1) Amount. Ad- (b) Sponsor. See No. 054771 in minister onto the oral mucosa between § 510.600(c) of this chapter. the dog’s cheek and gum at a dose of (c) Conditions of use—(1) Amount. 125 micrograms per square meter. Place 1 or 2 tablets deep in each uter- (2) Indications for use. For the treat- ine horn; or infuse a solution of 1 tab- ment of noise aversion in dogs. let disolved in an appropriate amount (3) Limitations. Federal law restricts of clean boiled water; or infuse one sy- this drug to use by or on the order of a ringe of suspension into the uterus. licensed veterinarian. (2) Indications for use. For prevention or treatment of metritis and vaginitis [81 FR 17608, Mar. 30, 2016] in cows and mares when caused by § 529.778 Doxycycline. pathogens sensitive to chlorhexidine dihydrochloride. (a) Specifications. Doxycycline (3) Limitations. Prior to administra- hyclate solution contains 8.5 percent tion, remove any unattached placental doxycycline activity. A syringe of N- membranes, any excess uterine fluid or methyl-2-pyrrolidone and poly (DL- debris, and carefully clean external lactide) mixed with a syringe of genitalia. Use a clean, sterile insemi- doxycycline produces 0.5 milliliter of nating pipette for administrating solu- solution. tions and suspensions. Treatment may (b) Sponsor. See 054771 in § 510.600(c) of be repeated in 48 to 72 hours. this chapter. (c) Conditions of use in dogs—(1) [43 FR 10705, Feb. 23, 1979, as amended at 79 Amount. Apply subgingivally to peri- FR 10973, Feb. 27, 2014; 81 FR 67152, Sept. 30, odontal pocket(s) of affected teeth. 2016] (2) Indications for use. For treatment EDITORIAL NOTE: At 79 FR 10973, Feb. 27, and control of periodontal disease. 2014, § 529.400 was amended by revising the (3) Limitations. Federal law restricts section heading, however, the section head- this drug to use by or on the order of a ing was not provided, therefore, the amend- licensed veterinarian. ment could not be incorporated because of an inaccurate amendatory instruction. [79 FR 10973, Feb. 27, 2014]

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§ 529.1030 Formalin. (iii) For control of fungi of the fam- (a) Specifications. Formalin is an ily Saprolegniaceae on finfish eggs: aqueous solution containing approxi- Eggs of all finfish except μ mately 37 percent by weight of form- Acipenseriformes, 1,000 to 2,000 L/L aldehyde gas, U.S.P. (ppm) for 15 minutes; eggs of (b) Sponsors. See Nos. 049968, 050378, Acipenseriformes, up to 1,500 μL/L and 067188 in § 510.600(c) of this chapter. (ppm) for 15 minutes. A preliminary (c) [Reserved] bioassay should be conducted on a (d) Conditions of use. It is added to en- small subsample of fish eggs to deter- vironmental water as follows: mine sensitivity before treating an en- (1) Indications for use. (i) Penaeid tire group. This is necessary for all spe- shrimp. For control of external proto- cies because egg sensitivity can vary zoan parasites Bodo spp., Epistylis spp., with species or strain and the unique and Zoothamnium spp. conditions at each facility. (ii) All finfish. For control of exter- (3) Limitations. Fish tanks and race- nal protozoa Ichthyophthirius spp., ways may be treated daily until para- Chilodonella spp., Ichthyobodo spp., site control is achieved. Pond treat- Ambiphrya spp., Epistylis spp., and ment may be repeated in 5 to 10 days if Trichodina spp., and the monogeneans needed. However, pond treatments for Cleidodiscus spp., Gyrodactylus spp., and Ichthyophthirius spp. should be made at Dactylogyrus spp. 2-day intervals until control is (iii) All finfish eggs: For control of achieved. Egg tanks may be treated as fungi of the family Saprolegniaceae. often as necessary to prevent growth of (2) Amount. The drug concentrations fungi. Do not use formalin which has required are as follows: (i) For control of external protozoan been subjected to temperatures below ° parasites on shrimp: 40 F, or allowed to freeze. Treatments in tanks and raceways should never ex- Concentration of formalin (microliters ceed 1 hour for fish or 4 hours for per liter) penaeid shrimp (even if they show no Shrimp Tanks and race- sign of distress), nor should it exceed 15 ways (up to 4 Earthen ponds hours daily) (single treatment) minutes for fish eggs. Do not apply formalin to ponds with water warmer Penaeid Shrimp ... 50 to 100 1 ...... 25 2 than 27 °C (80 °F), when a heavy bloom 1 Treat for up to 4 hours daily. Treatment may be repeated of phytoplankton is present, or when daily until parasite control is achieved. Use the lower concentration when tanks or raceways are heavily loaded with the concentration of dissolved oxygen phytoplankton or shrimp, to avoid oxygen depletion due to the is less than 5 milligrams per liter. biological oxygen demand created by decay of dead phytoplankton. Alternatively, a higher concentration might be used if dissolved oxygen is strictly monitored. [51 FR 11441, Apr. 3, 1986, as amended at 58 2 Single treatment. Treatment may be repeated in 5 to 10 FR 59169, Nov. 8, 1993; 59 FR 60076, Nov. 22, days if needed. 1994; 63 FR 38304, July 16, 1998; 68 FR 5563; (ii) For control of external parasites Feb. 4, 2003; 72 FR 45158, Aug. 13, 2007; 76 FR on finfish: 17339, Mar. 29, 2011; 79 FR 2786, Jan. 16, 2014; 82 FR 58556, Dec. 13, 2017] Administer in tanks and raceways for Administer in § 529.1044 Gentamicin in certain other up to 1 hour earthen ponds sin- Aquatic species (microliter/liter or gle treatment (μL/L dosage forms. part per million or ppm) μ ( L/L or ppm)) § 529.1044a Gentamicin solution for in- Salmon and trout: fusion. Above 50 °F Up to 170 15 to 25 12 Below 50 °F Up to 250 15 to 25 12 (a) Specifications. Each milliliter of All other finfish Up to 250 15 to 25 12 solution contains 50 or 100 milligrams 1 Use the lower concentration when ponds, tanks, or race- gentamicin sulfate. ways are heavily loaded with phytoplankton or fish to avoid (b) Sponsors. See Nos. 000061, 000859, oxygen depletion due to the biological oxygen demand by decay of dead phytoplankton. Alternatively, a higher con- 054628, 054771, 057561, 058005, and 061623 centration may be used if dissolved oxygen is strictly mon- in § 510.600(c) of this chapter. itored. 2 Although the indicated concentrations are considered safe (c) Conditions of use in horses—(1) for cold and warm water finfish, a small number of each lot or pond to be treated should always be used to check for any Amount. Infuse 2 to 2.5 grams per day unusual sensitivity to formalin before proceeding. for 3 to 5 days during estrus.

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(2) Indications for use. For control of sive, heavy liquid containing 0.01 per- bacterial infections of the uterus (me- cent thymol as a preservative. tritis) and as an aid in improving con- (b) Sponsor. See Nos. 012164 and 054771 ception in mares with uterine infec- in § 510.600(c) of this chapter. tions caused by bacteria sensitive to (c) Conditions of use—(1) Amount. Two gentamicin. to 5 percent of inhaled atmosphere for (3) Limitations. Do not use in horses induction of anesthesia; 0.5 to 2 percent intended for human consumption. Fed- for maintenance of anesthesia. eral law restricts this drug to use by or (2) Indications for use. For nonfood on the order of a licensed veterinarian. animals for the induction and mainte- [71 FR 51727, Aug. 31, 2006, as amended at 78 nance of anesthesia. FR 17597, Mar. 22, 2013; 78 FR 21060, Apr. 9, (3) Limitations. Not for use in animals 2013; 79 FR 10973, Feb. 27, 2014] intended for food. Federal law restricts this drug to use by or on the order of a § 529.1044b Gentamicin solution for licensed veterinarian. dipping eggs. (a) Specifications. Each milliliter of [46 FR 27915, May 22, 1981, as amended at 62 solution contains gentamicin sulfate FR 29014, May 29, 1997; 79 FR 10973, Feb. 27, equivalent to 50 milligrams of 2014] gentamicin base. § 529.1150 Hydrogen peroxide. (b) Sponsors. See Nos. 000061 and 054925 in § 510.600(c) of this chapter. (a) Specifications. Each milliliter of (c) Conditions of use in turkeys—(1) solution contains 396.1 milligrams (mg) Amount. The drug is added to clean hydrogen peroxide (a 35% w/w solu- water to provide a dip solution with a tion). gentamicin concentration of 250 to (b) Sponsor. See No. 050378 in 1,000 parts per million. A concentration § 510.600(c) of this chapter. of 500 parts per million is rec- (c) Conditions of use in finfish—(1) ommended. Clean eggs should be held Amount—(i) Freshwater-reared finfish submerged in the gentamicin solution eggs: 500 to 1,000 mg per liter (/L) of under a vacuum of about 27.5 to 38 cen- culture water for 15 minutes in a con- timeters of mercury for 5 minutes fol- tinuous flow system once per day on lowed by additional soaking in consecutive or alternate days until gentamicin solution for approximately hatch for all coldwater and coolwater 10 minutes at atmospheric pressure. species of freshwater-reared finfish Eggs can also be treated by warming eggs or 750 to 1,000 mg/L for 15 minutes them for 3 to 6 hours at approximately in a continuous flow system once per 100 °F then immediately submerging day on consecutive or alternate days them in gentamicin solution main- until hatch for all warmwater species tained at about 40 °F, keeping the eggs of freshwater-reared finfish eggs. submerged for 10 to 15 minutes. (ii) Freshwater-reared salmonids: 100 (2) Indications for use. As an aid in the mg/L for 30 minutes or 50 to 100 mg/L reduction or elimination of the fol- for 60 minutes once per day on alter- lowing microorganisms from turkey- nate days for three treatments in a hatching eggs: Arizona hinshawii continuous flow water supply or as a (paracolon), Salmonella Saintpaul, and static bath. Mycoplasma meleagridis. (iii) Coolwater species of freshwater- (3) Limitations. For use in the dipping reared finfish fingerlings and adults treatment of turkey-hatching eggs (except northern pike & paddlefish) and only. Eggs which have been dipped in channel catfish fingerlings and adults: the drug shall not be used for food. 50 to 75 mg/L for 60 minutes once per [40 FR 13881, Mar. 27, 1975, as amended at 52 day on alternate days for three treat- FR 7833, Mar. 13, 1987; 62 FR 22889, Apr. 28, ments in continuous flow water supply 1997; 71 FR 13543, Mar. 16, 2006; 79 FR 10973, or as a static bath. Coolwater species Feb. 27, 2014] of freshwater-reared finfish fry (except northern pike, pallid sturgeon & § 529.1115 Halothane. paddlefish) and channel catfish fry: 50 (a) Specifications. The drug is a color- mg/L for 60 minutes once per day on al- less, odorless, nonflammable, nonexplo- ternate days for three treatments in

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continuous flow water supply or as a eral law restricts this drug to use by or static bath. on the order of a licensed veterinarian. (2) Indications for use. For control of [51 FR 594, Jan. 7, 1986, as amended at 54 FR mortality in freshwater-reared finfish 23472, June 1, 1989; 58 FR 17346, Apr. 2, 1993; 59 eggs due to saprolegniasis; for control FR 44315, Aug. 29, 1994; 60 FR 40456, Aug. 9, of mortality in freshwater-reared 1995; 63 FR 8122, Feb. 18, 1998; 63 FR 24106, salmonids due to bacterial gill disease May 1, 1998; 66 FR 17510, Apr. 2, 2001; 71 FR associated with Flavobacterium 43967, Aug. 3, 2006; 74 FR 68530, Dec. 28, 2009; branchiophilum; and for control of mor- 76 FR 16533, Mar. 24, 2011; 78 FR 14669, Mar. 7, 2013; 78 FR 17868, Mar. 25, 2013; 80 FR 18776, tality in freshwater-reared coolwater Apr. 8, 2015; 82 FR 12170, Mar. 1, 2017] finfish and channel catfish due to external columnaris disease associated § 529.1350 Meloxicam. with Flavobacterium columnare (a) Specifications. Each milliliter of (Flexibacter columnaris). solution contains 5 milligrams (mg) (3) Limitations. Initial bioassay on a meloxicam. small number is recommended before (b) Sponsor. See No. 054771 in treating the entire group. Eggs: Some § 510.600(c) of this chapter. strains of rainbow trout eggs are sen- (c) Conditions of use in dogs—(1) sitive to hydrogen peroxide treatment Amount. Administer 0.1 mg per kilo- at a time during incubation concurrent gram of body weight once daily using with blastopore formation through clo- the metered dose pump. sure, about 70 to 140 Daily Temperature (2) Indications for use. For the control ° Units, C. Consider withholding treat- of pain and inflammation associated ment or using an alternate with osteoarthritis in dogs. therapeutant during that sensitive (3) Limitations. Federal law restricts time to reduce egg mortalities due to this drug to use by or on the order of a drug toxicity. Finfish: Use with cau- licensed veterinarian. tion on walleye. Preharvest withdrawal time: zero days. [77 FR 76863, Dec. 31, 2012, as amended at 80 FR 18776, Apr. 8, 2015] [72 FR 5330, Feb. 6, 2007, as amended at 78 FR 73698, Dec. 9, 2013] § 529.1660 Oxytetracycline. § 529.1186 Isoflurane. (a) Specifications—(1) Each gram of powder contains 366 milligrams (mg) (a) Specifications. The drug is a clear, oxytetracycline hydrochloride. colorless, stable liquid. (2) Each gram of powder contains 753 (b) Sponsors. See Nos. 012164, 054771, mg oxytetracycline hydrochloride. 065085, and 066794 in § 510.600(c) of this (b) Sponsors. See sponsors in chapter. § 510.600(c) of this chapter for use of (c) Conditions of use. Administer by products described in paragraph (a) of inhalation: this section as in paragraph (d) of this (1) Amount—(i) Horses: For induction section. of surgical anesthesia: 3 to 5 percent (1) Nos. 054771 and 061623 for use of isoflurane (with oxygen) for 5 to 10 product in paragraph (a)(1) of this sec- minutes. For maintenance of surgical tion. anesthesia: 1.5 to 1.8 percent isoflurane (2) Nos. 054771, 061623, and 069254 for (with oxygen). use of product described in paragraph (ii) Dogs: For induction of surgical (a)(2) of this section. anesthesia: 2 to 2.5 percent isoflurane (c) Related tolerances. See § 556.500 of (with oxygen) for 5 to 10 minutes. For this chapter. maintenance of surgical anesthesia: 1.5 (d) Conditions of use in finfish—(1) to 1.8 percent isoflurane (with oxygen). Amount. Immerse fish in a solution (2) Indications for use. For induction containing 200 to 700 mg oxytetra- and maintenance of general anesthesia cycline hydrochloride (buffered) per in horses and dogs. liter of water for 2 to 6 hours. (3) Limitations. Do not use in horses (2) Indications for use. For skeletal intended for human consumption. Fed- marking of finfish fry and fingerlings.

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(3) Limitations. Federal law restricts seminated at the immediately pre- this drug to use by or on the order of a ceding estrus. licensed veterinarian. (D) For induction of estrous cycles in [69 FR 6557, Feb. 11, 2004, as amended at 69 anestrous lactating dairy cows. FR 61999, Oct. 22, 2004; 70 FR 41140, July 18, (iii) Limitations. Do not use in beef or 2005; 72 FR 26289, May 9, 2007; 76 FR 17026, dairy heifers of insufficient size or age Mar. 28, 2011; 79 FR 10973, Feb. 27, 2014; 81 FR for breeding or in animals with abnor- 22524, Apr. 18, 2016; 81 FR 94991, Dec. 27, 2016] mal, immature, or infected genital § 529.1940 Progesterone intravaginal tracts. Do not use in beef cows that are inserts. fewer than 20 days postpartum. Do not use an insert more than once. To pre- (a) Specifications. Each insert contains: vent the potential transmission of ve- (1) 1.38 grams (g) progesterone in nereal and bloodborne diseases, the in- molded silicone over a nylon spine. serts should be disposed after a single (2) 0.3 g progesterone in molded sili- use. Administration of vaginal inserts cone over a flexible nylon spine. for periods greater than 7 days may re- (b) Sponsor. See No. 054771 in sult in reduced fertility. Dinoprost in- § 510.600(c) of this chapter for use of the jection for use in paragraphs product described in paragraph (a)(1) of (e)(1)(ii)(A) and (e)(1)(ii)(B) of this sec- this section as in paragraph (e)(1) of tion as in § 522.690 of this chapter, pro- this section; and the product described vided by No. 054771 in § 510.600(c) of this in paragraph (a)(2) of this section as in chapter. paragraph (e)(2) of this section. (2) Ewes—(i) Amount. Administer one (c) Related tolerances. See § 556.540 of intravaginal insert per animal for 5 this chapter. days. (d) Special considerations. Product la- (ii) Indications for use. For induction beling shall bear the following warn- of estrus in ewes (sheep) during sea- ing: ‘‘Avoid contact with skin by wear- sonal anestrus. ing protective gloves when handling in- (iii) Limitations. Do not use in ani- serts. Store removed inserts in a seal- mals with abnormal, immature, or in- able container until they can be dis- fected genital tracts; or in ewes that posed of in accordance with applicable local, state, and Federal regulations.’’ have never lambed. Do not use an in- (e) Conditions of use—(1) Cows—(i) sert more than once. To prevent the Amount. Administer one intravaginal potential transmission of venereal and insert per animal for 7 days. When used bloodborne diseases, the inserts should for indications listed in paragraph be disposed after a single use. (e)(1)(ii)(A) of this section, administer [74 FR 59074, Nov. 17, 2009, as amended at 75 25 mg dinoprost as a single FR 63085, Oct. 14, 2010; 79 FR 10965, 10974, Feb. intramuscular injection 1 day prior to 27, 2014; 79 FR 44278, July 31, 2014] insert removal (Day 6). When used for indications listed in paragraph § 529.2150 Sevoflurane. (e)(1)(ii)(B) of this section, administer (a) Specifications. Sevoflurane liquid. 25 mg dinoprost as a single (b) See Nos. 012164, 054771, intramuscular injection on the day of Sponsors. insert removal (Day 7). and 066794 in § 510.600(c) of this chapter. (ii) Indications for use—(A) For syn- (c) Conditions of use—(1) Amount. For chronization of estrus in suckled beef induction of surgical anesthesia: up to cows and replacement beef and dairy 7 percent sevoflurane. For maintenance heifers; for advancement of first of surgical anesthesia: 3.7 to 4 percent postpartum estrus in suckled beef sevoflurane with oxygen in the absence cows; and for advancement of first pu- of premedication and 3.3 to 3.6 percent bertal estrus in replacement beef heif- in the presence of premedication. ers. (2) Indications for use. For induction (B) For synchronization of estrus in and maintenance of general anesthesia lactating dairy cows. in dogs. (C) For synchronization of the return to estrus in lactating dairy cows in-

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(3) Limitations. Federal law restricts animals (poikilotherms) as an aid in this drug to use by or on the order of a handling during manual spawning (fish licensed veterinarian. stripping), weighing, measuring, mark- [64 FR 71640, Dec. 22, 1999, as amended at 73 ing, surgical operations, transport, FR 25508, May 7, 2008; 74 FR 10484, Mar. 11, photography, and research. 2009, 75 FR 1021, Jan. 8, 2010; 76 FR 16533, Mar. (3) Limitations. Do not use within 21 24, 2011; 78 FR 17868, Mar. 25, 2013; 80 FR 18776, days of harvesting fish for food. Use in Apr. 8, 2015] fish intended for food should be re- § 529.2464 Ticarcillin. stricted to Ictaluridae, Salmonidae, Esocidae, and Percidae, and water tem- (a) Specifications. Each vial contains perature exceeding 10 °C (50 °F). In ticarcillin disodium powder equivalent to 6 grams of ticarcillin for reconstitu- other fish and in coldblooded animals, tion with 25 milliliters of sterile water the drug should be limited to hatchery for injection or sterile physiological or laboratory use. saline. [79 FR 10974, Feb. 27, 2014] (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 529.2620 Triptorelin. (c) Conditions of use in horses—(1) Amount. Administer 6 grams daily by (a) Specifications. Each milliliter of intrauterine infusion for 3 consecutive gel contains 100 micrograms (mcg) days during estrus. triptorelin as triptorelin acetate. (2) Indications for use. For the treat- (b) Sponsor. See No. 051233 in ment of endometritis caused by beta- § 510.600(c) of this chapter. hemolytic streptococci. (c) Conditions of use in swine—(1) (3) Limitations. Do not use in horses Amount. Administer 200 mcg intended for human consumption. Fed- intravaginally approximately 96 hours eral law restricts this drug to use by or after weaning. on the order of a licensed veterinarian. (2) Indications for use. For the syn- [79 FR 10974, Feb. 27, 2014] chronization of time of insemination in weaned sows to facilitate a single § 529.2503 Tricaine methanesulfonate. fixed-time artificial insemination. (a) Specifications. The drug is ethyl-m- (3) Limitations. Not approved for use amino-benzoate methanesulfonate. in gilts. Safety and effectiveness have (b) Sponsor. See Nos. 050378 and 051212 not been evaluated in these animals. in § 510.600(c) of this chapter. Should not be used in sows with obvi- (c) Conditions of use—(1) Amount. It is ous reproductive tract abnormalities. used as follows: (i) Fish. The drug is added to ambient [77 FR 64717, Oct. 23, 2012] water at a concentration of from 15 to 330 milligrams per liter depending upon PART 530—EXTRALABEL DRUG USE the degree of anesthetization or seda- IN ANIMALS tion desired, the species and size of the fish, and the temperature and softness Subpart A—General Provisions of the water. Preliminary tests of solutions must be made with small num- Sec. bers of fish to determine the desired 530.1 Scope. rates of sedation or anesthesia and the 530.2 Purpose. appropriate exposure times for the spe- 530.3 Definitions. cific lots of fish under prevailing condi- 530.4 Advertising and promotion. tions. 530.5 Veterinary records. (ii) Amphibians and other aquatic coldblooded animals. The drug is added to Subpart B—Rules and Provisions for ambient water in concentrations of Extralabel Uses of Drugs in Animals from 1:1000 to 1:20,000 depending upon 530.10 Provision permitting extralabel use species and stage of development. of animal drugs. (2) Indications for use. For the tem- 530.11 Limitations. porary immobilization of fish, amphib- 530.12 Labeling. ians, and other aquatic coldblooded

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530.13 Extralabel use from compounding of the health of an animal is threatened approved new animal and approved or suffering or death may result from human drugs. failure to treat. This section imple- Subpart C—Specific Provisions Relating to ments the Animal Medicinal Drug Use Extralabel Use of Animal and Human Clarification Act of 1994 (the AMDUCA) Drugs in Food-Producing Animals (Pub. L. 103–396). 530.20 Conditions for permitted extralabel § 530.3 Definitions. animal and human drug use in food-producing animals. (a) Extralabel use means actual use or 530.21 Prohibitions for food-producing ani- intended use of a drug in an animal in mals. a manner that is not in accordance 530.22 Safe levels and analytical methods with the approved labeling. This infor food-producing animals. cludes, but is not limited to, use in spe- 530.23 Procedure for setting and announcing safe levels. cies not listed in the labeling, use for 530.24 Procedure for announcing analytical indications (disease or other condi- methods for drug residue quantification. tions) not listed in the labeling, use at 530.25 Orders prohibiting extralabel uses for dosage levels, frequencies, or routes of drugs in food-producing animals. administration other than those stated Subpart D—Extralabel Use of Human and in the labeling, and deviation from the Animal Drugs in Animals Not Intended labeled withdrawal time based on these for Human Consumption different uses. (b) FDA means the U.S. Food and 530.30 Extralabel drug use in nonfood ani- Drug Administration. mals. (c) The phrase a reasonable probability Subpart E—Safe Levels for Extralabel Use of that a drug’s use may present a risk to the Drugs in Animals and Drugs Prohibited public health means that FDA has rea- From Extralabel Use in Animals son to believe that use of a drug may be likely to cause a potential adverse 530.40 Safe levels and availability of analyt- event. ical methods. (d) The phrase use of a drug may 530.41 Drugs prohibited for extralabel use in animals. present a risk to the public health means that FDA has information that indi- AUTHORITY: 15 U.S.C. 1453, 1454, 1455; 21 cates that use of a drug may cause an U.S.C. 321, 331, 351, 352, 353, 355, 357, 360b, 371, 379e. adverse event. (e) The phrase use of a drug presents a SOURCE: 61 FR 57743, Nov. 7, 1996, unless otherwise noted. risk to the public health means that FDA has evidence that demonstrates that Subpart A—General Provisions the use of a drug has caused or likely will cause an adverse event. § 530.1 Scope. (f) A residue means any compound This part applies to the extralabel present in edible tissues that results use in an animal of any approved new from the use of a drug, and includes the animal drug or approved new human drug, its metabolites, and any other drug by or on the lawful order of a li- substance formed in or on food because censed veterinarian within the context of the drug’s use. of a valid veterinary-client-patient re- (g) A safe level is a conservative esti- lationship. mate of a drug residue level in edible animal tissue derived from food safety § 530.2 Purpose. data or other scientific information. The purpose of this part is to estab- Concentrations of residues in tissue lish conditions for extralabel use or in- below the safe level will not raise tended extralabel use in animals by or human food safety concerns. A safe on the lawful order of licensed veteri- level is not a safe concentration or a narians of Food and Drug Administra- tolerance and does not indicate that an tion approved new animal drugs and approval exists for the drug in that approved new human drugs. Such use is species or category of animal from limited to treatment modalities when which the food is derived.

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(h) Veterinarian means a person li- lated from more than one ingredient, censed by a State or Territory to prac- the established name of each ingre- tice veterinary medicine. dient; (i) A valid veterinarian-client-patient (2) The condition treated; relationship is one in which: (3) The species of the treated ani- (1) A veterinarian has assumed the mal(s); responsibility for making medical (4) The dosage administered; judgments regarding the health of (an) (5) The duration of treatment; animal(s) and the need for medical (6) The numbers of animals treated; treatment, and the client (the owner of and the animal or animals or other care- (7) The specified withdrawal, with- taker) has agreed to follow the instruc- holding, or discard time(s), if applications of the veterinarian; ble, for meat, milk, eggs, or any food (2) There is sufficient knowledge of which might be derived from any food the animal(s) by the veterinarian to animals treated. initiate at least a general or prelimi- (b) A veterinarian shall keep all re- nary diagnosis of the medical condition quired records for 2 years or as other- of the animal(s); and wise required by Federal or State law, (3) The practicing veterinarian is whichever is greater. readily available for followup in case of (c) Any person who is in charge, con- adverse reactions or failure of the regi- trol, or custody of such records shall, men of therapy. Such a relationship upon request of a person designated by can exist only when the veterinarian FDA, permit such person designated by has recently seen and is personally ac- FDA to, at all reasonable times, have quainted with the keeping and care of access to, permit copying, and verify the animal(s) by virtue of examination such records. of the animal(s), and/or by medically appropriate and timely visits to the Subpart B—Rules and Provisions premises where the animal(s) are kept. for Extralabel Uses of Drugs in Animals § 530.4 Advertising and promotion. Nothing in this part shall be con- § 530.10 Provision permitting strued as permitting the advertising or extralabel use of animal drugs. promotion of extralabel uses in ani- An approved new animal drug or mals of approved new animal drugs or human drug intended to be used for an approved human drugs. extralabel purpose in an animal is not unsafe under section 512 of the act and § 530.5 Veterinary records. is exempt from the labeling require- (a) As a condition of extralabel use ments of section 502(f) of the act if such permitted under this part, to permit use is: FDA to ascertain any extralabel use or (a) By or on the lawful written or intended extralabel use of drugs that oral order of a licensed veterinarian the agency has determined may within the context of a valid veteri- present a risk to the public health, vet- narian-client-patient relationship; and erinarians shall maintain the following (b) In compliance with this part. records of extralabel uses. Such records shall be legible, documented in an ac- § 530.11 Limitations. curate and timely manner, and be read- In addition to uses which do not com- ily accessible to permit prompt re- ply with the provision set forth in trieval of information. Such records § 530.10, the following specific shall be adequate to substantiate the extralabel uses are not permitted and identification of the animals and shall result in the drug being deemed unsafe be maintained either as individual within the meaning of section 512 of records or, in food animal practices, on the act: a group, herd, flock, or per-client basis. (a) Extralabel use in an animal of an Records shall be adequate to provide approved new animal drug or human the following information: drug by a lay person (except when (1) The established name of the drug under the supervision of a licensed vet- and its active ingredient, or if formu- erinarian);

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(b) Extralabel use of an approved new (b) Extralabel use from compounding animal drug or human drug in or on an of approved new animal or human animal feed; drugs is permitted if: (c) Extralabel use resulting in any (1) All relevant portions of this part residue which may present a risk to have been complied with; the public health; and (2) There is no approved new animal (d) Extralabel use resulting in any or approved new human drug that, residue above an established safe level, when used as labeled or in conformity safe concentration or tolerance. with criteria established in this part, will, in the available dosage form and § 530.12 Labeling. concentration, appropriately treat the Any human or animal drug pre- condition diagnosed. Compounding scribed and dispensed for extralabel use from a human drug for use in food-pro- by a veterinarian or dispensed by a ducing animals will not be permitted if pharmacist on the order of a veteri- an approved animal drug can be used narian shall bear or be accompanied by for the compounding; labeling information adequate to as- (3) The compounding is performed by sure the safe and proper use of the a licensed pharmacist or veterinarian product. Such information shall in- within the scope of a professional prac- clude the following: tice; (a) The name and address of the pre- (4) Adequate procedures and proc- scribing veterinarian. If the drug is dis- esses are followed that ensure the safe- pensed by a pharmacy on the order of a ty and effectiveness of the compounded veterinarian, the labeling shall include product; the name of the prescribing veteri- (5) The scale of the compounding op- narian and the name and address of the eration is commensurate with the es- dispensing pharmacy, and may include tablished need for compounded prod- the address of the prescribing veteri- ucts (e.g., similar to that of com- narian; parable practices); and (b) The established name of the drug (6) All relevant State laws relating to or, if formulated from more than one the compounding of drugs for use in active ingredient, the established name animals are followed. of each ingredient; (c) Guidance on the subject of (c) Any directions for use specified by compounding may be found in guidance the veterinarian, including the class/ documents issued by FDA. species or identification of the animal or herd, flock, pen, lot, or other group of animals being treated, in which the Subpart C—Specific Provisions Re- drug is intended to be used; the dosage, lating to Extralabel Use of Ani- frequency, and route of administration; mal and Human Drugs in and the duration of therapy; Food-Producing Animals (d) Any cautionary statements; and (e) The veterinarian’s specified with- § 530.20 Conditions for permitted drawal, withholding, or discard time extralabel animal and human drug use in food-producing animals. for meat, milk, eggs, or any other food which might be derived from the treat- (a) The following conditions must be ed animal or animals. met for a permitted extralabel use in food-producing animals of approved § 530.13 Extralabel use from new animal and human drugs: compounding of approved new ani- (1) There is no approved new animal mal and approved human drugs. drug that is labeled for such use and (a) This part applies to compounding that contains the same active ingre- of a product from approved animal or dient which is in the required dosage human drugs by a veterinarian or a form and concentration, except where a pharmacist on the order of a veteri- veterinarian finds, within the context narian within the practice of veteri- of a valid veterinarian-client-patient nary medicine. Nothing in this part relationship, that the approved new shall be construed as permitting animal drug is clinically ineffective for compounding from bulk drugs. its intended use.

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(2) Prior to prescribing or dispensing (b) A prohibition may be a general an approved new animal or human drug ban on the extralabel use of the drug or for an extralabel use in food animals, class of drugs or may be limited to a the veterinarian must: specific species, indication, dosage (i) Make a careful diagnosis and eval- form, route of administration, or com- uation of the conditions for which the bination of factors. drug is to be used; (ii) Establish a substantially ex- § 530.22 Safe levels and analytical tended withdrawal period prior to mar- methods for food-producing ani- keting of milk, meat, eggs, or other ed- mals. ible products supported by appropriate (a) FDA may establish a safe level for scientific information, if applicable; extralabel use of an approved human (iii) Institute procedures to assure drug or an approved new animal drug that the identity of the treated animal when the agency finds that there is a or animals is carefully maintained; and reasonable probability that an (iv) Take appropriate measures to as- extralabel use may present a risk to sure that assigned timeframes for with- the public health. FDA may: drawal are met and no illegal drug resi- (1) Establish a finite safe level based dues occur in any food-producing ani- on residue and metabolism information mal subjected to extralabel treatment. from available sources; (b) The following additional condi- (2) Establish a safe level based on the tions must be met for a permitted lowest level that can be measured by a extralabel use of in food-producing ani- practical analytical method; or mals an approved human drug, or of an (3) Establish a safe level based on animal drug approved only for use in other appropriate scientific, technical, animals not intended for human con- or regulatory criteria. sumption: (1) Such use must be accomplished in (b) FDA may require the develop- accordance with an appropriate med- ment of an acceptable analytical meth- ical rationale; and od for the quantification of residues (2) If scientific information on the above any safe level established under human food safety aspect of the use of this part. If FDA requires the develop- the drug in food-producing animals is ment of such an acceptable analytical not available, the veterinarian must method, the agency will publish notice take appropriate measures to assure of that requirement in the FEDERAL that the animal and its food products REGISTER. will not enter the human food supply. (c) The extralabel use of an animal (c) Extralabel use of an approved drug or human drug that results in res- human drug in a food-producing animal idues exceeding a safe level established is not permitted under this part if an under this part is an unsafe use of such animal drug approved for use in food- drug. producing animals can be used in an (d) If the agency establishes a safe extralabel manner for the particular level for a particular species or cat- use. egory of animals and a tolerance or safe concentration is later established § 530.21 Prohibitions for food-pro- through an approval for that particular ducing animals. species or category of animals, for that (a) FDA may prohibit the extralabel species or category of animals, the safe use of an approved new animal or level is superseded by the tolerance or human drug or class of drugs in food- safe concentration for that species or producing animals if FDA determines category of animals. that: (1) An acceptable analytical method § 530.23 Procedure for setting and an- needs to be established and such meth- nouncing safe levels. od has not been established or cannot (a) FDA may issue an order estab- be established; or lishing a safe level for a residue of an (2) The extralabel use of the drug or extralabel use of an approved human class of drugs presents a risk to the drug or an approved animal drug. The public health. agency will publish in the FEDERAL

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REGISTER a notice of the order. The no- ducing animals if the agency finds, tice will include: after providing an opportunity for pub- (1) A statement setting forth the lic comment, that: agency’s finding that there is a reason- (1) An acceptable analytical method able probability that extralabel use in required under § 530.22 has not been de- animals of the human drug or animal veloped, submitted, and found to be ac- drug may present a risk to the public ceptable by FDA or that such method health; cannot be established; or (2) A statement of the basis for that (2) The extralabel use in animals pre- finding; and sents a risk to the public health. (3) A request for public comments. (b) After making a determination (b) A current listing of those drugs that the analytical method required for which a safe level for extralabel under § 530.22 has not been developed drug use in food-producing animals has and submitted, or that such method been established, the specific safe lev- cannot be established, or that an els, and the availability, if any, of a extralabel use in animals of a par- specific analytical method or methods ticular human drug or animal drug pre- for drug residue detection will be codi- sents a risk to the public health, FDA fied in § 530.40. will publish in the FEDERAL REGISTER, with a 90-day delayed effective date, an § 530.24 Procedure for announcing an- order of prohibition for an extralabel alytical methods for drug residue use of a drug in food-producing ani- quantification. mals. Such order shall state that an ac- (a) FDA may issue an order announc- ceptable analytical method required ing a specific analytical method or under § 530.22 has not been developed, methods for the quantification of submitted, and found to be acceptable extralabel use drug residues above the by FDA; that such method cannot be safe levels established under § 530.22 for established; or that the extralabel use extralabel use of an approved human in animals presents a risk to the public drug or an approved animal drug. The health; and shall: agency will publish in the FEDERAL (1) Specify the nature and extent of REGISTER a notice of the order, includ- the order of prohibition and the rea- ing the name of the specific analytical sons for the prohibition; method or methods and the drug or (2) Request public comments; and drugs for which the method is applica- (3) Provide a period of not less than ble. 60 days for comments. (b) Copies of analytical methods for (c) The order of prohibition will be- the quantification of extralabel use come effective 90 days after date of drug residues above the safe levels es- publication of the order unless FDA tablished under § 530.22 will be available publishes a notice in the FEDERAL REG- upon request from the Communications ISTER prior to that date, that revokes and Education Branch (HFV–12), Divi- the order of prohibition, modifies it, or sion of Program Communication and extends the period of public comment. Administrative Management, Center (d) The agency may publish an order for Veterinary Medicine, 7500 Standish of prohibition with a shorter comment Pl., Rockville, MD 20855. When an ana- period and/or delayed effective date lytical method for the detection of than specified in paragraph (b) of this extralabel use drug residues above the section in exceptional circumstances safe levels established under § 530.22 is (e.g., where there is immediate risk to developed, and that method is accept- the public health), provided that the able to the agency, FDA will incor- order of prohibition states that the porate that method by reference. comment period and/or effective date have been abbreviated because there § 530.25 Orders prohibiting extralabel are exceptional circumstances, and the uses for drugs in food-producing order of prohibition sets forth the animals. agency’s rationale for taking such ac- (a) FDA may issue an order prohib- tion. iting extralabel use of an approved new (e) If FDA publishes a notice in the animal or human drug in food-pro- FEDERAL REGISTER modifying an order

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of prohibition, the agency will specify Subpart E—Safe Levels for in the modified order of prohibition the Extralabel Use of Drugs in Ani- nature and extent of the modified pro- mals and Drugs Prohibited hibition, the reasons for it, and the From Extralabel Use in Ani- agency’s response to any comments on mals the original order of prohibition. (f) A current listing of drugs prohib- § 530.40 Safe levels and availability of ited for extralabel use in animals will analytical methods. be codified in § 530.41. (a) In accordance with § 530.22, the (g) After the submission of appro- following safe levels for extralabel use priate information (i.e., adequate data, of an approved animal drug or human an acceptable method, approval of a drug have been established: [Reserved] new animal drug application for the (b) In accordance with § 530.22, the prohibited extralabel use, or informa- following analytical methods have tion demonstrating that the prohibi- been accepted by FDA: [Reserved] tion was based on incorrect data), FDA § 530.41 Drugs prohibited for may, by publication of an appropriate extralabel use in animals. notice in the FEDERAL REGISTER, re- (a) The following drugs, families of move a drug from the list of human drugs, and substances are prohibited and animal drugs prohibited for for extralabel animal and human drug extralabel use in animals, or may mod- uses in food-producing animals. ify a prohibition. (1) Chloramphenicol; (h) FDA may prohibit extralabel use (2) Clenbuterol; of a drug in food-producing animals (3) Diethylstilbestrol (DES); without establishing a safe level. (4) Dimetridazole; (5) Ipronidazole; Subpart D—Extralabel Use of (6) Other nitroimidazoles; Human and Animal Drugs in (7) Furazolidone. (8) Nitrofurazone. Animals Not Intended for (9) Sulfonamide drugs in lactating Human Consumption dairy cattle (except approved use of sulfadimethoxine, § 530.30 Extralabel drug use in sulfabromomethazine, and nonfood animals. sulfaethoxypyridazine); (a) Because extralabel use of animal (10) Fluoroquinolones; and and human drugs in nonfood-producing (11) Glycopeptides. animals does not ordinarily pose a (12) Phenylbutazone in female dairy threat to the public health, extralabel cattle 20 months of age or older. use of animal and human drugs is per- (13) Cephalosporins (not including mitted in nonfood-producing animal cephapirin) in cattle, swine, chickens, practice except when the public health or turkeys: is threatened. In addition, the provi- (i) For disease prevention purposes; (ii) At unapproved doses, frequencies, sions of § 530.20(a)(1) will apply to the durations, or routes of administration; use of an approved animal drug. or (b) If FDA determines that an (iii) If the drug is not approved for extralabel drug use in animals not in- that species and production class. tended for human consumption pre- (b) The following drugs, families of sents a risk to the public health, the drugs, and substances are prohibited agency may publish in the FEDERAL for extralabel animal and human drug REGISTER a notice prohibiting such use uses in nonfood-producing animals: following the procedures in § 530.25. The [Reserved] prohibited extralabel drug use will be (c) [Reserved] codified in § 530.41. (d) The following drugs, or classes of drugs, that are approved for treating or preventing influenza A, are prohibited from extralabel use in chickens, turkeys, and ducks:

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(1) Adamantanes. 556.360 Lincomycin. (2) Neuraminidase inhibitors. 556.375 Maduramicin ammonium. 556.380 Melengestrol acetate. [62 FR 27947, May 22, 1997, as amended at 67 556.410 Metoserpate hydrochloride. FR 5471, Feb. 6, 2002; 68 FR 9530, Feb. 28, 2003; 556.420 Monensin. 68 FR 14134, Mar. 24, 2003; 71 FR 14377, Mar. 556.425 Morantel tartrate. 22, 2006; 77 FR 745, Jan. 6, 2012] 556.426 Moxidectin. 556.428 Narasin. PART 556—TOLERANCES FOR RESI- 556.430 Neomycin. DUES OF NEW ANIMAL DRUGS IN 556.440 Nequinate. 556.445 Nicarbazin. FOOD 556.460 Novobiocin. 556.470 Nystatin. Subpart A—General Provisions 556.490 Ormetoprim. 556.495 Oxfendazole. Sec. 556.1 General considerations; tolerances for 556.500 Oxytetracycline. residues of new animal drugs in food. 556.510 Penicillin. 556.513 Piperazine. Subpart B—Specific Tolerances for 556.515 Pirlimycin. Residues of New Animal Drugs 556.540 Progesterone. 556.560 Pyrantel tartrate. 556.34 Albendazole. 556.570 Ractopamine. 556.36 Altrenogest. 556.580 Robenidine hydrochloride. 556.38 Amoxicillin. 556.592 Salinomycin. 556.40 Ampicillin. 556.597 Semduramicin. 556.50 Amprolium. 556.600 Spectinomycin. 556.52 Apramycin. 556.610 Streptomycin. 556.68 Avilamycin. 556.620 Sulfabromomethazine sodium. 556.70 Bacitracin. 556.625 Sodium sulfachloropyrazine 556.100 Carbadox. monohydrate. 556.110 Carbomycin. 556.630 Sulfachlorpyridazine. 556.113 Ceftiofur. 556.640 Sulfadimethoxine. 556.115 Cephapirin. 556.650 Sulfaethoxypyridazine. 556.118 Chloramine-T. 556.660 Sulfamerazine. 556.120 Chlorhexidine. 556.670 Sulfamethazine. 556.150 Chlortetracycline. 556.685 Sulfaquinoxaline. 556.160 Clopidol. 556.700 Sulfomyxin. 556.163 Clorsulon. 556.710 Testosterone propionate. 556.165 Cloxacillin. 556.720 Tetracycline. 556.167 Colistimethate. 556.730 Thiabendazole. 556.169 Danofloxacin. 556.170 Decoquinate. 556.732 Tiamulin. 556.180 Dichlorvos. 556.733 Tildipirosin. 556.185 Diclazuril. 556.735 Tilmicosin. 556.200 Dihydrostreptomycin. 556.739 Trenbolone. 556.225 Doramectin. 556.740 Tylosin. 556.226 Enrofloxacin. 556.741 Tripelennamine. 556.227 Eprinomectin. 556.745 Tulathromycin. 556.230 Erythromycin. 556.748 Tylvalosin. 556.240 Estradiol and related esters. 556.750 Virginiamycin. 556.260 Ethopabate. 556.760 Zeranol. 556.273 Famphur. 556.765 Zilpaterol. 556.275 Fenbendazole. 556.770 Zoalene. 556.277 Fenprostalene. AUTHORITY: 21 U.S.C. 342, 360b, 371. 556.283 Florfenicol. 556.286 Flunixin. SOURCE: 40 FR 13942, Mar. 27, 1975, unless 556.292 Gamithromycin. otherwise noted. 556.300 Gentamicin sulfate. 556.304 Gonadotropin. Subpart A—General Provisions 556.308 Halofuginone hydrobromide. 556.310 Haloxon. § 556.1 General considerations; toler- 556.330 Hygromycin B. ances for residues of new animal 556.344 Ivermectin. drugs in food. 556.346 Laidlomycin. 556.347 Lasalocid. (a) Tolerances established in this 556.350 Levamisole hydrochloride. part are based upon residues of drugs in

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edible products of food-producing ani- the toxicity of the drug residue and of mals treated with such drugs. Consid- the unlikelihood of such residue’s ex- eration of an appropriate tolerance for ceeding the tolerance. a drug shall result in a conclusion either that: Subpart B—Specific Tolerances for (1) Finite residues will be present in Residues of New Animal Drugs the edible products—in which case a finite tolerance is required; or § 556.34 Albendazole. (2) It is not possible to determine whether finite residues will be incurred (a) Acceptable daily intake (ADI). The but there is reasonable expectation ADI for total residues of albendazole is that they may be present—in which 5 micrograms per kilogram of body case a tolerance for negligible residue weight per day. is required; or (b) Tolerances. The tolerances for (3) The drug induces cancer when in- albendazole 2-aminosulfone (marker gested by man or animal or, after tests residue) are: which are appropriate for the evalua- (1) Cattle—(i) Liver (target tissue): 0.2 tion of the safety of such drug, has parts per million (ppm). been shown to induce cancer in man or (ii) Muscle: 0.05 ppm. animal; however, such drug will not ad- (2) Sheep—(i) Liver (target tissue): 0.25 versely affect the animals for which it ppm. is intended, and no residue of such drug (ii) Muscle: 0.05 ppm. will be found by prescribed methods of (3) Goat—(i) Liver (target tissue): 0.25 analysis in any edible portion of such ppm. animals after slaughter or in any food (ii) [Reserved] yielded by or derived from the living (c) Related conditions of use. See animal—in which case the accepted § 520.45 of this chapter. method of analysis shall be published [64 FR 1504, Jan. 11, 1999, as amended at 73 or cited, if previously published and FR 11027, Feb. 29, 2008] available elsewhere, in this part; or (4) It may or may not be possible to § 556.36 Altrenogest. determine whether finite residues will (a) Acceptable Daily Intake (ADI). The be incurred but there is no reasonable ADI for total residues of altrenogest is expectation that they may be present— 0.04 micrograms per kilogram of body in which case the establishment of a weight per day. tolerance is not required; or (b) —(1) —(i) (5) The drug is such that it may be Tolerances Swine Liver (the The tolerance for metabolized and/or assimilated in such target tissue). altrenogest (the marker residue) is 4 form that any possible residue would parts per billion (ppb). be indistinguishable from normal tissue constituents—in which case the es- (ii) Muscle. The tolerance for tablishment of a tolerance is not re- altrenogest (the marker residue) is 1 quired. ppb. (b) No tolerance established pursuant (2) [Reserved] to paragraph (a)(1) of this section will [68 FR 62007, Oct. 31, 2003] be set at any level higher than that reflected by the permitted use of the § 556.38 Amoxicillin. drug. A tolerance of 0.01 part per million is (c) Any tolerance required pursuant established for negligible residues of to this section will, in addition to the amoxicillin in milk and in the toxicological considerations, be condi- uncooked edible tissues of cattle. tioned on the availability of a practicable analytical method to determine [49 FR 45422, Nov. 16, 1984] the quantity of residue. Such method must be sensitive to and reliable at the § 556.40 Ampicillin. established tolerance level or, in cer- A tolerance of 0.01 p/m is established tain instances, may be sensitive at a for negligible residues of ampicillin in higher level where such level is also the uncooked edible tissues of swine deemed satisfactory and safe in light of and cattle and in milk.

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§ 556.50 Amprolium. swine, chickens, turkeys, pheasants, Tolerances are established as follows and quail, and in milk and eggs is 0.5 for residues of amprolium (1-(4-amino- part per million. 2-n- propyl-5-pyrimidinylmethyl)-2- (c) Related conditions of use. See picolinium chloride hydrochloride): §§ 520.154a, 520.154c, 558.76, and 558.78 of (a) In the edible tissues and in eggs of this chapter. chickens and turkeys: [65 FR 70791, Nov. 28, 2000, as amended at 81 (1) 1 part per million in uncooked FR 17608, Mar. 30, 2016] liver and kidney. (2) 0.5 part per million in uncooked § 556.100 Carbadox. muscle tissue. A tolerance of 30 parts per billion is (3) In eggs: established for residues of quinoxaline- (i) 8 parts per million in egg yolks. 2-carboxylic acid (marker residue) in (ii) 4 parts per million in whole eggs. liver (target tissue) of swine. (b) In the edible tissues of calves: (1) 2.0 parts per million in uncooked [63 FR 13337, Mar. 19, 1998] fat. (2) 0.5 part per million in uncooked § 556.110 Carbomycin. muscle tissue, liver, and kidney. A tolerance of zero is established for (c) In the edible tissues of pheasants: residues of carbomycin in the uncooked (1) 1 part per million in uncooked edible tissues of chickens. liver. (2) 0.5 part per million in uncooked § 556.113 Ceftiofur. muscle. (a) Acceptable daily intake and accept- [40 FR 13942, Mar. 27, 1975, as amended at 50 able single-dose intake—(1) Acceptable FR 18472, May 1, 1985] daily intake (ADI). The ADI for total residues of ceftiofur is 30 micrograms § 556.52 Apramycin. per kilogram of body weight per day. A tolerance of 0.1 part per million is (2) Acceptable single-dose intake established for parent apramycin (ASDI). The ASDI total residues of (marker residue) in kidney (target tis- ceftiofur is 0.830 milligrams per kilo- sue) of swine. The acceptable daily in- gram of body weight. The ASDI is the take (ADI) for total residues of amount of total residues of ceftiofur apramycin is 25 micrograms per kilo- that may safely be consumed in a sin- gram of body weight per day. gle meal. The ASDI is used to derive the tolerance for residues of [62 FR 40933, July 31, 1997] desfuroylceftiofur at the injection site. § 556.68 Avilamycin. (b) Tolerances—(1) Poultry, and sheep. A tolerance for residues of ceftiofur in (a) Acceptable Daily Intake (ADI). The ADI for total residues of avilamycin is edible tissue is not required. 1.1 milligram per kilogram of body (2) Swine. The tolerances for weight per day. desfuroylceftiofur (marker residue) (b) Tolerances. A tolerance for are: avilamycin is not required. (i) Kidney (target tissue). 0.25 parts per (c) Related conditions of use. See million (ppm). § 558.68 of this chapter. (ii) Liver. 3 ppm. (iii) Muscle. 2 ppm. [80 FR 61297, Oct. 13, 2015] (3) Cattle. The tolerances for § 556.70 Bacitracin. desfuroylceftiofur (marker residue) are: (a) Acceptable daily intake (ADI). The (i) Kidney (target tissue). 0.4 ppm. ADI for total residues of bacitracin is (ii) Liver. 2 ppm. 0.05 milligram per kilogram of body weight per day. (iii) Muscle. 1 ppm. (b) Tolerances. The tolerance for resi- (iv) Milk. 0.1 ppm. dues of bacitracin from zinc bacitracin [63 FR 53579, Oct. 6, 1998, as amended at 68 FR or bacitracin methylenedisalicylate in 60296, Oct. 22, 2003; 69 FR 43892, July 23, 2004; uncooked edible tissues of cattle, 71 FR 39546, July 13, 2006]

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§ 556.115 Cephapirin. (1) 15 parts per million in uncooked liver and kidney. A tolerance of 0.02 parts per million (ppm) is established for residues of (2) 5 parts per million in uncooked cephapirin in the milk and 0.1 ppm in muscle. the uncooked edible tissues of dairy (c) In cattle, sheep, and goats: cattle. (1) 3 parts per million in uncooked kidney. [40 FR 57454, Dec. 10, 1975] (2) 1.5 parts per million in uncooked liver. § 556.118 Chloramine-T. (3) 0.2 part per million in uncooked (a) Acceptable Daily Intake (ADI). The muscle. ADI for total residues of chloramine-T (d) In swine: 0.2 part per million in is 5 micrograms per kilogram of body uncooked edible tissues. weight per day. (e) In milk: 0.02 part per million (neg- (b) Tolerances—(1) Fish—(i) Muscle/ ligible residue). skin (target tissue). The tolerance for para-toluenesulfonamide (marker res- § 556.163 Clorsulon. idue) is 0.90 parts per million. (a) Acceptable daily intake (ADI). The (ii) [Reserved] ADI for total residues of clorsulon is 8 (2) [Reserved] micrograms per kilogram of body (c) Related conditions of use. See weight per day. § 529.382 of this chapter. (b) Tolerances—(1) Cattle—(i) Kidney [79 FR 37621, July 2, 2014] (the target tissue). The tolerance for parent clorsulon (the marker residue) is § 556.120 Chlorhexidine. 1.0 part per million. A tolerance of zero is established for (ii) Muscle. The tolerance for parent residues of chlorhexidine in the clorsulon (the marker residue) is 0.1 uncooked edible tissues of calves. part per million. (2) [Reserved] § 556.150 Chlortetracycline. [66 FR 35544, July 6, 2001] (a) Acceptable daily intake (ADI). The ADI for total residues of tetracyclines § 556.165 Cloxacillin. including chlortetracycline, oxytetra- A tolerance of 0.01 part per million is cycline, and tetracycline is 25 established for negligible residues of micrograms per kilogram of body cloxacillin in the uncooked edible tis- weight per day. sues of cattle and in milk. (b) Tolerances. (1) Tolerances are established for the sum of tetracycline [40 FR 28792, July 9, 1975] residues in tissues of beef cattle, nonlactating dairy cows, calves, swine, § 556.167 Colistimethate. sheep, chickens, turkeys, and ducks, of A tolerance for residues of 2 parts per million (ppm) in muscle, 6 colistimethate in the edible tissues of ppm in liver, and 12 ppm in fat and kid- chickens is not required. ney. [63 FR 13123, Mar. 18, 1998] (2) A tolerance is established for residues of chlortetracycline in eggs of 0.4 § 556.169 Danofloxacin. ppm. (a) Acceptable daily intake (ADI). The [63 FR 52158, Sept. 30, 1998, as amended at 63 ADI for total residues of danofloxacin FR 57246, Oct. 27, 1998] is 2.4 micrograms per kilogram of body weight per day. § 556.160 Clopidol. (b) Tolerances—(1) Cattle—(i) Liver Tolerances for residues of clopidol (the target tissue). The tolerance for par- (3,5-dichloro-2,6-dimethyl-4-pyridinol) ent danofloxacin (the marker residue) in food are established as follows: is 0.2 part per million (ppm). (a) In cereal grains, vegetables, and (ii) Muscle. The tolerance for parent fruits: 0.2 part per million. danofloxacin (the marker residue) is 0.2 (b) In chickens and turkeys: ppm.

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(2) [Reserved] kidney and 0.5 ppm in other tissues, and 0.125 ppm in milk. [67 FR 78973, Dec. 27, 2002] [59 FR 41977, Aug. 16, 1994] § 556.170 Decoquinate. (a) Acceptable daily intake (ADI). The § 556.225 Doramectin. ADI for total residues of decoquinate is (a) Acceptable daily intake (ADI). The 75 micrograms per kilogram of body ADI for total residues of doramectin is weight per day. 0.75 microgram per kilogram of body (b) Tolerances. Tolerances are estab- weight per day. lished for residues of decoquinate in (b) Tolerances—(1) Cattle. A tolerance the uncooked, edible tissues of chick- of 100 parts per billion is established ens, cattle, and goats as follows: for parent doramectin (marker residue) (1) 1 part per million (ppm) in skel- in liver (target tissue) and of 30 parts etal muscle. per billion for parent doramectin in (2) 2 ppm in other tissues. muscle. (2) Swine. A tolerance is established [64 FR 10103, Mar. 2, 1999] for parent doramectin (marker residue) § 556.180 Dichlorvos. in liver (target tissue) of 160 parts per billion. A tolerance of 0.1 part per million is established for negligible residues of [63 FR 68184, Dec. 10, 1998] dichlorvos (2,2-dichlorovinyl dimethyl phosphate) in the edible tissues of § 556.226 Enrofloxacin. swine. (a) Acceptable daily intake (ADI). The ADI for total residues of enrofloxacin § 556.185 Diclazuril. is 3 micrograms per kilogram of body (a) Acceptable daily intake (ADI). The weight per day. ADI for total residues of diclazuril is 25 (b) Tolerances. The tolerances for micrograms per kilogram of body enrofloxacin are: weight per day. (1) Cattle—(i) Liver (target tissue). 0.1 (b) Tolerances—(1) Chickens—(i) Liver. part per million (ppm) desethylene The tolerance for parent diclazuril (the ciprofloxacin (the marker residue). marker residue) is 3 parts per million (ii) [Reserved] (ppm). (2) Swine—(i) Liver (target tissue). 0.5 (ii) Muscle. The tolerance for parent ppm enrofloxacin (the marker residue). diclazuril (the marker residue) is 0.5 (ii) [Reserved] ppm. (c) Related conditions of use. See (iii) Skin/fat. The tolerance for parent § 522.812 of this chapter. diclazuril (the marker residue) is 1 ppm. [73 FR 21819, Apr. 23, 2008] (2) Turkeys—(i) Liver. The tolerance § 556.227 Eprinomectin. for parent diclazuril (the marker residue) is 3 ppm. (a) Acceptable daily intake (ADI). The (ii) Muscle. The tolerance for parent ADI for total residues of eprinomectin diclazuril (the marker residue) is 0.5 is 10 micrograms per kilogram of body ppm. weight per day. (iii) Skin/fat. The tolerance for parent (b) Tolerances. The tolerances for diclazuril (the marker residue) is 1 eprinomectin B1a (marker residue) are: ppm. (1) Cattle—(i) Liver (target tissue): 1.5 parts per million. [64 FR 35923, July 2, 1999. Redesignated and amended at 66 FR 62917, Dec. 4, 2001] (ii) Muscle: 100 parts per billion (ppb). (iii) Milk: 12 ppb. § 556.200 Dihydrostreptomycin. (2) [Reserved] Tolerances are established for resi- (c) Related conditions of use. See dues of dihydrostreptomycin in §§ 522.814 and 524.814 of this chapter. uncooked, edible tissues of cattle and [63 FR 59715, Nov. 5, 1998, as amended at 76 swine of 2.0 parts per million (ppm) in FR 72619, Nov. 25, 2011]

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§ 556.230 Erythromycin. (b) Tolerances—(1) Cattle—(i) Liver (the target tissue). The tolerance for par- Tolerances for residues of erythro- ent fenbendazole (the marker residue) mycin in food are established as fol- is 0.8 part per million (ppm). lows: (ii) Muscle. The tolerance for parent (a) 0.1 part per million in uncooked fenbendazole (the marker residue) is 0.4 edible tissues of beef cattle and swine. ppm. (b) Zero in milk. (iii) Milk. The tolerance for (c) 0.025 part per million in uncooked fenbendazole sulfoxide metabolite (the eggs. marker residue in cattle milk) is 0.6 (d) 0.125 part per million (negligible ppm. residue) in uncooked edible tissues of (2) Swine—(i) Liver (the target tissue). chickens and turkeys. The tolerance for parent fenbendazole [40 FR 13942, Mar. 27, 1975, as amended at 58 (the marker residue) is 3.2 ppm. FR 43795, Aug. 18, 1993] (ii) Muscle. The tolerance for parent fenbendazole (the marker residue) is 2 § 556.240 Estradiol and related esters. ppm. (3) Chickens—(i) Liver (the target tis- No residues of estradiol, resulting sue). The tolerance for fenbendazole from the use of estradiol or any of the sulfone (the marker residue) is 5.2 ppm. related esters, are permitted in excess (ii) [Reserved] of the following increments above the (4) Turkeys—(i) Liver (the target tis- concentrations of estradiol naturally sue). The tolerance for fenbendazole present in untreated animals: sulfone (the marker residue) is 6 ppm. (a) In uncooked edible tissues of heif- (ii) Muscle. The tolerance for ers, steers, and calves: fenbendazole sulfone (the marker res- (1) 120 parts per trillion for muscle. idue) is 2 ppm. (2) 480 parts per trillion for fat. (5) Goats—(i) Liver (the target tissue). (3) 360 parts per trillion for kidney. The tolerance for parent fenbendazole (4) 240 parts per trillion for liver. (the marker residue) is 0.8 ppm. (b) [Reserved] (ii) Muscle. The tolerance for parent fenbendazole (the marker residue) is 0.4 [49 FR 13873, Apr. 9, 1984, as amended at 56 FR 67175, Dec. 30, 1991; 76 FR 16291, Mar. 23, ppm. 2011] (c) Related conditions of use. See §§ 520.905a, 520.905c, 520.905d, 520.905e, § 556.260 Ethopabate. and 558.258 of this chapter. Tolerance for residues of ethopabate [65 FR 20733, Apr. 18, 2000, as amended at 65 converted to metaphenetidine are es- FR 41588, July 6, 2000; 65 FR 50914, Aug. 22, tablished in the edible tissues of chick- 2000; 81 FR 22524, Apr. 18, 2016] ens as follows: § 556.277 Fenprostalene. (a) 1.5 parts per million in uncooked liver and kidney. A tolerance for marker residue of (b) 0.5 part per million in uncooked fenprostalene in cattle is not needed. muscle. The safe concentrations for the total residues of fenprostalene in the § 556.273 Famphur. uncooked edible tissues of cattle are 10 parts per billion in muscle, 20 parts per Tolerances are established for resi- billion in liver, 30 parts per billion in dues of famphur including its oxygen kidney, 40 parts per billion in fat, and analog in or on meat, fat, or meat by- 100 parts per billion in the injection products of cattle at 0.1 part per mil- site. As used in this section ‘‘toler- lion. ance’’ refers to a concentration of a [62 FR 55161, Oct. 23, 1997] marker residue in the target tissue selected to monitor for total residues of § 556.275 Fenbendazole. the drug in the target animal, and (a) Acceptable daily intake (ADI). The ‘‘safe concentrations’’ refer to the con- ADI for total residues of fenbendazole centrations of total residues considered is 40 micrograms per kilogram of body safe in edible tissues. weight per day. [49 FR 26716, June 29, 1984]

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§ 556.283 Florfenicol. § 556.292 Gamithromycin. (a) Acceptable daily intake (ADI). The (a) Acceptable Daily Intake (ADI). The ADI for total residues of florfenicol is ADI for total residues of 10 micrograms per kilogram of body gamithromycin is 10 micrograms per weight per day. kilogram of body weight per day. (b) Tolerances—(1) Cattle—(i) Liver (b) Tolerances. The tolerances for (the target tissue). The tolerance for gamithromycin (the marker residue) florfenicol amine (the marker residue) are: is 3.7 parts per million (ppm). (1) Cattle—(i) Liver (the target tissue): 500 parts per billion (ppb). (ii) Muscle. The tolerance for (ii) Muscle. 150 ppb. florfenicol amine (the marker residue) (2) [Reserved] is 0.3 ppm. (c) Related conditions of use. See (2) Swine—(i) Liver (the target tissue). § 522.1014 of this chapter. The tolerance for parent florfenicol (the marker residue) is 2.5 ppm. [76 FR 57907, Sept. 19, 2011] (ii) Muscle. The tolerance for parent § 556.300 Gentamicin sulfate. florfenicol (the marker residue) is 0.2 ppm. (a) A tolerance of 0.1 part per million is established for negligible residues of (3) Freshwater-reared finfish (other gentamicin sulfate in the uncooked ed- than catfish) and salmonids. The toler- ible tissues of chickens and turkeys. ance for florfenicol amine (the marker (b) Tolerances are established for residue) in muscle/skin (the target tis- total residues of gentamicin in edible sues) is 1 ppm. tissues of swine as follows: 0.1 part per (4) Catfish. The tolerance for million in muscle, 0.3 part per million florfenicol amine (the marker residue) in liver, and 0.4 part per million in fat in muscle (the target tissues) is 1 ppm. and kidney. A microbiological deter- (c) Related conditions of use. See minative procedure and an HPLC con- §§ 520.955, 522.955, 522.956, and 558.261 of firmatory procedure for gentamicin this chapter. have been developed to assay gentamicin in kidney at 0.4 ppm. Since [76 FR 16291, Mar. 23, 2011, as amended at 81 FR 17608, Mar. 30, 2016] residues of gentamicin as the parent compound and total residues are equal, § 556.286 Flunixin. the marker (parent drug) residue concentration of 0.4 ppm in kidney cor- (a) Acceptable daily intake (ADI). The responds to 0.4 ppm of total residue. ADI for total residues of flunixin is 0.72 micrograms per kilogram of body [48 FR 791, Jan. 7, 1983, as amended at 61 FR weight per day. 24441, May 15, 1996] (b) Tolerances—(1) Cattle. The toler- § 556.304 Gonadotropin. ance for flunixin free acid (the marker (a) Acceptable daily intake (ADI). The residue) is: ADI for residues of total gonadotropins (i) Liver (the target tissue). 125 parts (human chorionic gonadotropin and per billion (ppb). pregnant mare serum gonadotropin) is (ii) Muscle. 25 ppb. 42.25 I.U. per kilogram of body weight (iii) Milk: 2 ppb 5-hydroxy flunixin. per day. (2) Swine. The tolerance for flunixin (b) Tolerances. A tolerance for resi- free acid (the marker residue) is: dues of gonadotropin in uncooked edi- (i) Liver (the target tissue). 30 ppb. ble tissues of cattle or of fish is not re- (ii) Muscle. 25 ppb. quired. (c) Related conditions of use. See [64 FR 48545, Sept. 7, 1999] §§ 522.956, 522.970, and 524.970 of this chapter. § 556.308 Halofuginone hydrobromide. [63 FR 38750, July 20, 1998, as amended at 69 The marker residue selected to mon- FR 60309, Oct. 8, 2004; 70 FR 70999, Nov. 25, itor for total residues of halofuginone 2005; 76 FR 16291, Mar. 23, 2011; 83 FR 13635, hydrobromide in broilers and turkeys Mar. 30, 2018] is parent halofuginone hydrobromide

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and the target tissue selected is liver. (2) Muscle. Muscle residues are not in- A tolerance is established in broilers of dicative of the safety of other edible 0.16 part per million and in turkeys of tissues. A tolerance is established for 0.13 part per million for parent 22,23-dihydroavermectin B1a (marker halofuginone hydrobromide in liver. residue) in muscle as follows: These marker residue concentrations (i) Swine. 20 parts per billion. in liver correspond to total residue (ii) Cattle. 650 parts per billion. concentrations of 0.3 part per million (c) Related conditions of use. See in liver. The safe concentrations for §§ 520.1192, 520.1195, 520.1197, 522.1192, total residues of halofuginone 522.1193, 524.1193, and 558.300 of this hydrobromide in the uncooked edible chapter. tissues of broilers and turkeys are 0.1 [63 FR 54352, Oct. 9, 1998, as amended at 64 FR part per million in muscle, 0.3 part per 26671, May 17, 1999; 79 FR 64117, Oct. 28, 2014] million in liver, and 0.2 part per million in skin with adhering fat. As used § 556.346 Laidlomycin. in this section, ‘‘tolerance’’ refers to a (a) Acceptable daily intake (ADI). The concentration of a marker residue in ADI for total residues of laidlomycin is the target tissue selected to monitor 7.5 micrograms per kilogram of body for total residues of the drug in the weight per day. target animal, and ‘‘safe concentra- (b) Tolerance. The tolerance for par- tions’’ refers to the concentrations of ent laidlomycin (the marker residue) total residues considered safe in edible in the liver (the target tissue) of cattle tissues. is 0.2 part per million (ppm). [54 FR 28052, July 5, 1989, as amended at 56 [68 FR 42590, July 18, 2003] FR 8711, Mar. 1, 1991; 57 FR 21209, May 19, 1992] § 556.347 Lasalocid. (a) Acceptable daily intake (ADI). The § 556.310 Haloxon. ADI for total residues of lasalocid is 10 A tolerance of 0.1 part per million is micrograms per kilogram of body established for negligible residues of weight per day. haloxon (3-chloro-7-hydroxy-4-methyl- (b) Tolerances—(1) Cattle. The toler- coumarin bis(2-chloroethyl) phosphate) ance for parent lasalocid (the marker in the edible tissues of cattle. residue) in liver (the target tissue) is 0.7 part per million (ppm). [40 FR 13942, Mar. 27, 1975, as amended at 45 FR 10333, Feb. 15, 1980] (2) Chickens—(i) Skin with adhering fat (the target tissue). The tolerance for par- § 556.330 Hygromycin B. ent lasalocid (the marker residue) is 1.2 ppm. A tolerance of zero is established for (ii) Liver. The tolerance for parent residues of hygromycin B in or on eggs lasalocid (the marker residue) is 0.4 and the uncooked edible tissues of ppm. swine and poultry. (3) Turkeys—(i) Liver (the target tissue). The tolerance for parent lasalocid § 556.344 Ivermectin. (the marker residue) is 0.4 ppm. (a) Acceptable Daily Intake (ADI). The (ii) Skin with adhering fat. The toler- ADI for total residues of ivermectin is ance for parent lasalocid (the marker 5 micrograms per kilogram of body residue) is 0.4 ppm. weight per day. (4) Rabbits. The tolerance for parent (b) Tolerances—(1) Liver. A tolerance lasalocid (the marker residue) in liver is established for 22,23- (the target tissue) is 0.7 ppm. dihydroavermectin B1a (marker res- (5) Sheep. The tolerance for parent idue) in liver (target tissue) as follows: lasalocid (the marker residue) in liver (i) Cattle. 1.6 parts per million. (the target tissue) is 1.0 ppm. (ii) Swine. 20 parts per billion. [66 FR 19854, Apr. 18, 2001] (iii) Sheep. 30 parts per billion. (iv) Reindeer. 15 parts per billion. § 556.350 Levamisole hydrochloride. (v) American bison. 15 parts per bil- A tolerance of 0.1 part per million is lion. established for negligible residues of

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levamisole hydrochloride in the edible 12.5 micrograms per kilogram of body tissues of cattle, sheep, and swine. weight per day. (b) Tolerances. The tolerances for res- § 556.360 Lincomycin. idues of monensin are: (a) Acceptable daily intake (ADI). The (1) Cattle—(i) Liver. 0.10 part per mil- ADI for total residues of lincomycin is lion (ppm). 25 micrograms per kilogram of body (ii) Muscle, kidney, and fat. 0.05 ppm. weight per day. (iii) Milk. Not required. (b) Chickens. A tolerance for residues (2) Goats—(i) Edible tissues. 0.05 ppm. of lincomycin in chickens is not re- (ii) [Reserved] quired. (3) Chickens, turkeys, and quail. A tol- (c) Swine. Tolerances for lincomycin erance for residues of monensin in of 0.6 part per million in liver and 0.1 chickens, turkeys, and quail is not re- part per million in muscle are estab- quired. lished. (c) Related conditions of use. See §§ 520.1448 and 558.355 of this chapter. [64 FR 13342, Mar. 18, 1999] [64 FR 5159, Feb. 3, 1999, as amended at 69 FR § 556.375 Maduramicin ammonium. 68783, Nov. 26, 2004; 72 FR 56897, Oct. 5, 2007] A tolerance is established for resi- § 556.425 Morantel tartrate. dues of maduramicin ammonium in chickens as follows: A tolerance of 0.7 part per million is (a) A tolerance for maduramicin am- established for N-methyl-1,3- monium (marker residue) in chickens propanediamine (MAPA, marker res- is 0.38 parts per million in fat (target idue) in the liver (target tissue) of cat- tissue). A tolerance refers to the con- tle and goats. A tolerance for residues centration of marker residues in the of morantel tartrate in milk is not re- target tissue used to monitor for total quired. drug residues in the target animals. [59 FR 17922, Apr. 15, 1994] (b) The safe concentrations for total maduramicin ammonium residues in § 556.426 Moxidectin. uncooked edible chicken tissues are: (a) Acceptable daily intake (ADI). The 0.24 parts per million in muscle; 0.72 ADI for total residues of moxidectin is parts per million in liver; 0.48 parts per 4 micrograms per kilogram of body million in skin; and 0.48 parts per mil- weight per day. lion in fat. A safe concentration refers (b) Tolerances—(1) Cattle—(i) Fat (the to the total residue concentration con- target tissue). The tolerance for parent sidered safe in edible tissues. moxidectin (the marker residue) is 900 [54 FR 5229, Feb. 2, 1989] parts per billion (ppb). (ii) Liver. The tolerance for parent § 556.380 Melengestrol acetate. moxidectin (the marker residue) is 200 A tolerance of 25 parts per billion is ppb. established for residues of the parent (iii) Muscle. The tolerance for parent compound, melengestrol acetate, in fat moxidectin (the marker residue) is 50 of cattle. ppb. (iv) Milk. The tolerance for parent [59 FR 41241, Aug. 11, 1994] moxidectin (the marker residue) is 40 ppb. § 556.410 Metoserpate hydrochloride. (2) Sheep—(i) Fat (the target tissue). A tolerance of 0.02 part per million is The tolerance for parent moxidectin established for negligible residues of (the marker residue) is 900 parts per metoserpate hydrochloride (methyl-o- billion (ppb). methyl-18-epireserpate hydrochloride) (ii) Liver. The tolerance for parent in uncooked edible tissues of chickens. moxidectin (the marker residue) is 200 ppb. § 556.420 Monensin. (iii) Muscle. The tolerance for parent (a) Acceptable daily intake (ADI). The moxidectin (the marker residue) is 50 ADI for total residues of monensin is ppb.

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(c) Related conditions of use. See sues of cattle, chickens, turkeys, and §§ 520.1454 and 522.1450 of this chapter. ducks. [65 FR 36617, June 9, 2000, as amended at 65 [47 FR 18590, Apr. 30, 1982] FR 76930, Dec. 8, 2000; 70 FR 36338, June 23, 2005; 70 FR 76163, Dec. 23, 2005] § 556.470 Nystatin. A tolerance of zero is established for § 556.428 Narasin. residues of nystatin in or on eggs and (a) Acceptable daily intake (ADI). The the uncooked edible tissues of swine ADI for total residues of narasin is 5 and poultry. micrograms per kilogram of body weight per day. § 556.490 Ormetoprim. (b) Tolerances—(1) Chickens (abdominal (a) [Reserved] fat). The tolerance for parent narasin (b) Tolerances. A tolerance of 0.1 part (the marker residue) is 480 parts per per million (ppm) is established for billion. negligible residues of ormetoprim in (2) [Reserved] uncooked edible tissues of chickens, [66 FR 23589, May 9, 2001] turkeys, ducks, salmonids, catfish, and chukar partridges. § 556.430 Neomycin. [64 FR 26672, May 17, 1999] (a) Acceptable daily intake (ADI). The ADI for total residues of neomycin is 6 § 556.495 Oxfendazole. micrograms per kilogram of body Cattle: A tolerance is established for weight per day. total oxfendazole residues in edible (b) Tolerances. Tolerances are estab- cattle tissues based on a marker res- lished for residues of parent neomycin idue concentration of 0.8 part per mil- in uncooked edible tissues as follows: lion (ppm) fenbendazole in the target (1) Cattle, swine, sheep, and goats. 7.2 liver tissue. A fenbendazole concentra- parts per million (ppm) in kidney (tar- tion of 0.8 ppm in liver corresponds to get tissue) and fat, 3.6 ppm in liver, and a total safe concentration of 1.2 ppm in muscle. oxfendazole residues of 1.7 ppm in liver. (2) Turkeys. 7.2 ppm in skin with The safe concentrations of total adhearing fat, 3.6 ppm in liver, and 1.2 oxfendazole residues in other uncooked ppm in muscle. edible cattle tissues are: muscle, 0.84 (3) Milk. A tolerance is established ppm; kidney, 2.5 ppm; and fat, 3.3 ppm. for residues of parent neomycin of 0.15 A tolerance refers to the concentration ppm. of marker residue in the target tissue selected to monitor for total drug res- [64 FR 31498, June 11, 1999] idue in the target animal. A safe con- § 556.440 Nequinate. centration is the total residue considered safe in edible tissue. A tolerance of 0.1 part per million is established for negligible residues of [55 FR 46943, Nov. 8, 1990] nequinate in the uncooked edible tissues of chickens. § 556.500 Oxytetracycline. (a) Acceptable daily intake (ADI). The § 556.445 Nicarbazin. ADI for total tetracycline residues A tolerance of 4 parts per million is (chlortetracycline, oxytetracycline, established for residues of nicarbazin in and tetracycline) is 25 micrograms per uncooked chicken muscle, liver, skin, kilogram of body weight per day. and kidney. (b) Beef cattle, dairy cattle, calves, swine, sheep, chickens, turkeys, finfish, [42 FR 56729, Oct. 28, 1977] and lobster. Tolerances are established for the sum of residues of the § 556.460 Novobiocin. tetracyclines including chlortetra- Tolerances for residues of novobiocin cycline, oxytetracycline, and tetra- are established at 0.1 part per million cycline, in tissues and milk as follows: in milk from dairy animals and 1 part (1) 2 parts per million (ppm) in mus- per million in the uncooked edible tis- cle.

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(2) 6 ppm in liver. (ii) Liver: 15 ppb. (3) 12 ppm in fat and kidney. (iii) Kidney: 30 ppb. (4) 0.3 ppm in milk. (iv) Fat: 30 ppb. (2) [Reserved] [63 FR 57246, Oct. 27, 1998, as amended at 66 (c) Related conditions of use. See FR 46370, Sept. 5, 2001; 69 FR 6557, Feb. 11, 2004] §§ 522.1940 and 529.1940 of this chapter. [76 FR 57907, Sept. 19, 2011] § 556.510 Penicillin. Tolerances are established for resi- § 556.560 Pyrantel tartrate. dues of penicillin and the salts of peni- Tolerances are established for resi- cillin in food as follows: dues of pyrantel tartrate in edible tis- (a) 0.05 part per million (negligible sues of swine as follows: residue) in the uncooked edible tissues (a) 10 parts per million in liver and of cattle. kidney. (b) Zero in the uncooked edible tis- (b) 1 part per million in muscle. sues of chickens, pheasants, quail, swine, and sheep; in eggs; and in milk § 556.570 Ractopamine. or in any processed food in which such (a) Acceptable Daily Intake (ADI). The milk has been used. ADI for total residues of ractopamine (c) 0.01 part per million in the hydrochloride is 1.25 micrograms per uncooked edible tissues of turkeys. kilogram of body weight per day. [40 FR 13942, Mar. 27, 1975, as amended at 43 (b) Tolerances—(1) Cattle—(i) Liver FR 32749, July 28, 1978] (the target tissue). The tolerance for ractopamine hydrochloride (the mark- § 556.513 Piperazine. er residue) is 0.09 parts per million A tolerance of 0.1 part per million pi- (ppm). perazine base is established for edible (ii) Muscle. The tolerance for tissues of poultry and swine. ractopamine hydrochloride (the marker residue) is 0.03 ppm. [64 FR 23019, Apr. 29, 1999] (2) Swine—(i) Liver (the target tissue). The tolerance for ractopamine hydro- § 556.515 Pirlimycin. chloride (the marker residue) is 0.15 (a) Acceptable daily intake (ADI). The ppm. ADI for total residues of pirlimycin is (ii) Muscle. The tolerance for 0.01 milligrams per kilogram of body ractopamine hydrochloride (the mark- weight per day. er residue) is 0.05 ppm. (b) Tolerances—(1) Cattle—(i) Liver (3) Turkeys—(i) Liver (the target tis- (the target tissue). The tolerance for par- sue). The tolerance for ractopamine ent pirlimycin (the marker residue) is (the marker residue) is 0.45 ppm. 0.5 part per million (ppm). (ii) Muscle. The tolerance for (ii) Muscle. The tolerance for parent ractopamine (the marker residue) is 0.1 pirlimycin (the marker residue) is 0.3 ppm. ppm. [68 FR 54659, Sept. 18, 2003, as amended at 73 (iii) Milk. The tolerance for parent FR 72715, Dec. 1, 2008] pirlimycin (the marker residue in cattle milk) is 0.4 ppm. § 556.580 Robenidine hydrochloride. (2) [Reserved] Tolerances are established for resi- [65 FR 61091, Oct. 16, 2000] dues of robenidine hydrochloride in edible tissues of chickens as follows: § 556.540 Progesterone. (a) 0.2 part per million in skin and (a) [Reserved] fat. (b) Tolerances. Residues of progester- (b) 0.1 part per million (negligible one are not permitted in excess of the residue) in edible tissues other than following increments above the con- skin and fat. centrations of progesterone naturally present in untreated animals: § 556.592 Salinomycin. (1) Cattle and sheep—(i) Muscle: 5 (a) Acceptable daily intake (ADI). The parts per billion (ppb). ADI for total residues of salinomycin is

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0.005 milligram per kilogram of body § 556.625 Sodium sulfachloropyrazine weight per day. monohydrate. (b) [Reserved] A tolerance of zero is established for [65 FR 70791, Nov. 28, 2000] residues of sodium sulfachloropyrazine monohydrate in the uncooked edible § 556.597 Semduramicin. tissues of chickens. (a) Acceptable daily intake (ADI). The ADI for total residues of semduramicin § 556.630 Sulfachlorpyridazine. is 180 micrograms per kilogram of body A tolerance of 0.1 part per million is weight per day. established for negligible residues of (b) Tolerances—(1) Broiler chickens. sulfachlorpyridazine in uncooked edi- Tolerances are established for residues ble tissues of calves and swine. of parent semduramicin in uncooked edible tissues of 400 parts per billion § 556.640 Sulfadimethoxine. (ppb) in liver and 130 ppb in muscle. (a) [Reserved] (2) [Reserved] (b) Tolerances. (1) A tolerance of 0.1 [64 FR 48296, Sept. 3, 1999] part per million (ppm) is established for negligible residues of § 556.600 Spectinomycin. sulfadimethoxine in uncooked edible (a) Acceptable daily intake (ADI). The tissues of chickens, turkeys, cattle, ADI for total residues of spectinomycin ducks, salmonids, catfish, and chukar is 25 micrograms per kilogram of body partridges. weight per day. (2) A tolerance of 0.01 ppm is estab- (b) Chickens and turkeys. A tolerance lished for negligible residues of of 0.1 part per million (ppm) for neg- sulfadimethoxine in milk. ligible residues of spectinomycin in uncooked edible tissues of chickens [64 FR 26672, May 17, 1999] and turkeys is established. (c) Cattle. A tolerance of 4 ppm for § 556.650 Sulfaethoxypyridazine. parent spectinomycin (marker residue) Tolerances for residues of in kidney (target tissue) is established. sulfaethoxypyridazine in food are es- A tolerance of 0.25 ppm for parent tablished as follows: spectinomycin in cattle muscle is es- (a) Zero in the uncooked edible tis- tablished. sues of swine and in milk. [63 FR 24107, May 1, 1998; 63 FR 38304, July 16, (b) 0.1 part per million (negligible 1998] residue) in uncooked edible tissues of cattle. § 556.610 Streptomycin. Tolerances are established for resi- § 556.660 Sulfamerazine. dues of streptomycin in uncooked, edi- A tolerance of zero is established for ble tissues of chickens, swine, and residues of sulfamerazine (N1-[4-meth- calves of 2.0 parts per million (ppm) in yl-2-pyrimidinyl]sulfanilamide) in the kidney and 0.5 ppm in other tissues. uncooked edible tissues of trout. [58 FR 47211, Sept. 8, 1993] § 556.670 Sulfamethazine. § 556.620 Sulfabromomethazine sodium. A tolerance of 0.1 part per million is established for negligible residues of Tolerances for residues of sulfamethazine in the uncooked edible sulfabromomethazine sodium in food tissues of chickens, turkeys, cattle, are established as follows: and swine. (a) In the uncooked edible tissues of cattle at 0.1 part per million (negligible [47 FR 25323, June 11, 1982] residue). (b) In milk at 0.01 part per million § 556.685 Sulfaquinoxaline. (negligible residue). A tolerance of 0.1 part per million is [47 FR 30244, July 13, 1982] established for negligible residues of

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sulfaquinoxaline in the uncooked edi- (marker compound) in liver (target tis- ble tissues of chickens, turkeys, calves, sue) of swine. and cattle. [62 FR 12086, Mar. 14, 1997. Redesignated at 80 [61 FR 24443, May 15, 1996] FR 13230, Mar. 13, 2015]

§ 556.700 Sulfomyxin. § 556.733 Tildipirosin. (a) Acceptable Daily Intake (ADI). The A tolerance of zero is established for ADI for total residues of tildipirosin is residues of sulfomyxin (N-sulfomethyl- 50 micrograms per kilogram of body polymyxin B sodium salt) in uncooked weight per day. edible tissues from chickens and tur- (b) Tolerances. The tolerances for keys. tildipirosin (the marker residue) are: (1) Cattle—(i) Liver (the target tissue): § 556.710 Testosterone propionate. 10 parts per million. No residues of testosterone, resulting (ii) [Reserved] from the use of testosterone propio- (2) [Reserved] nate, are permitted in excess of the fol- (c) Related conditions of use. See lowing increments above the con- § 522.2460 of this chapter. centrations of testosterone naturally [77 FR 39391, July 3, 2012, as amended at 78 present in untreated animals: FR 52854, Aug. 27, 2013] (a) In uncooked edible tissues of heifers: § 556.735 Tilmicosin. (1) 0.64 part per billion in muscle. (a) Acceptable daily intake (ADI). The (2) 2.6 parts per billion in fat. ADI for total residues of tilmicosin is (3) 1.9 parts per billion in kidney. 25 micrograms per kilogram of body (4) 1.3 parts per billion in liver. weight per day. (b) [Reserved] (b) Tolerances—(1) Cattle—(i) Liver (the target tissue). The tolerance for par- [52 FR 27683, July 23, 1987] ent tilmicosin (the marker residue) is 1.2 parts per million (ppm). § 556.720 Tetracycline. (ii) Muscle. The tolerance for parent (a) Acceptable daily intake (ADI). The tilmicosin (the marker residue) is 0.1 ADI for total tetracycline residues ppm. (chlortetracycline, oxytetracycline, (2) Swine—(i) Liver (the target tissue). and tetracycline) is 25 micrograms per The tolerance for parent tilmicosin kilogram of body weight per day. (the marker residue) is 7.5 ppm. (b) Tolerances. Tolerances are estab- (ii) Muscle. The tolerance for parent lished for the sum of tetracycline resi- tilmicosin (the marker residue) is 0.1 dues in tissues of calves, swine, sheep, ppm. chickens, and turkeys, of 2 parts per (3) Sheep—(i) Liver (the target tissue). million (ppm) in muscle, 6 ppm in liver, The tolerance for parent tilmicosin and 12 ppm in fat and kidney. (the marker residue) is 1.2 ppm. (ii) Muscle. The tolerance for parent [63 FR 57246, Oct. 27, 1998] tilmicosin (the marker residue) is 0.1 ppm. § 556.730 Thiabendazole. [64 FR 13679, Mar. 22, 1999, as amended at 67 Tolerances are established at 0.1 part FR 72368, Dec. 5, 2002; 78 FR 52854, Aug. 27, per million for negligible residues of 2013] thiabendazole in uncooked edible tissues of cattle, goats, sheep, pheasants, § 556.739 Trenbolone. and swine, and at 0.05 part per million (a) Acceptable daily intake (ADI). The for negligible residues in milk. ADI for total residues of trenbolone is [40 FR 13942, Mar. 27, 1975, as amended at 49 0.4 microgram per kilogram of body FR 29958, July 25, 1984] weight per day. (b) Tolerances. A tolerance for total § 556.732 Tiamulin. trenbolone residues in uncooked edible A tolerance of 0.6 part per million is tissues of cattle is not needed. established for 8-alpha-hydroxymutilin [64 FR 18574, Apr. 15, 1999]

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§ 556.740 Tylosin. § 556.750 Virginiamycin. Tolerances are established for resi- (a) Acceptable daily intake (ADI). The dues of tylosin in edible products of ADI for total residues of virginiamycin animals as follows: is 250 micrograms per kilogram of body (a) In chickens and turkeys: 0.2 part weight per day. per million (negligible residue) in (b) Tolerances—(1) Swine. Tolerances uncooked fat, muscle, liver, and kid- are established for residues of ney. virginiamycin in uncooked edible tis- (b) In cattle: 0.2 part per million sues of 0.4 part per million (ppm) in (negligible residue) in uncooked fat, kidney, skin, and fat, 0.3 ppm in liver, muscle, liver, and kidney. and 0.1 ppm in muscle. (c) In swine: 0.2 part per million (neg- (2) Broiler chickens and cattle. A toler- ligible residue) in uncooked fat, mus- ance for residues of virginiamycin is cle, liver, and kidney. not required. (d) In milk: 0.05 part per million (neg- [64 FR 48296, Sept. 3, 1999] ligible residue). (e) In eggs: 0.2 part per million (neg- § 556.760 Zeranol. ligible residue). (a) Acceptable daily intake (ADI). The ADI for total residues of zeranol is § 556.741 Tripelennamine. 0.00125 milligrams per kilogram of body A tolerance of 200 parts per billion weight per day. (ppb) is established for residues of (b) Tolerances. The tolerances for res- tripelennamine in uncooked edible tis- idues of zeranol in edible tissues are: sues of cattle and 20 ppb in milk. (1) Cattle. A tolerance is not needed. [62 FR 4164, Jan. 29, 1997] (2) Sheep. 20 parts per billion. (c) Related conditions of use. See § 556.745 Tulathromycin. § 522.2680 of this chapter. (a) Acceptable daily intake (ADI). The [40 FR 13942, Mar. 27, 1975, as amended at 54 ADI for total residues of tulathromycin FR 31950, Aug. 3, 1989; 67 FR 6867, Feb. 14, is 15 micrograms per kilogram of body 2002; 70 FR 15759, Mar. 29, 2005] weight per day. § 556.765 Zilpaterol. (b) Tolerances—(1) Cattle—(i) Liver (the target tissue). The tolerance for CP– (a) Acceptable daily intake (ADI). The 60,300 (the marker residue) is 5.5 parts ADI for total residues of zilpaterol is per million (ppm). 0.083 micrograms per kilogram of body (ii) [Reserved] weight per day. (2) Swine—(i) Kidney (the target tis- (b) Tolerances—(1) Cattle—(i) Liver sue). The tolerance for CP–60,300 (the (the target tissue). The tolerance for marker residue) is 15 ppm. zilpaterol (the marker residue) is 12 (ii) [Reserved] parts per billion (ppb). (c) Related conditions of use. See (ii) Muscle. The tolerance for § 522.2630 of this chapter. zilpaterol (the marker residue) is 10 ppb. [70 FR 39918, July 12, 2005] (2) [Reserved] (c) Related conditions of use. See § 556.748 Tylvalosin. § 558.665 of this chapter. (a) Acceptable Daily Intake (ADI). The [71 FR 53005, Sept. 8, 2006, as amended at 81 ADI for total residues of tylvalosin is FR 17608, Mar. 30, 2016] 47.7 micrograms per kilogram of body weight per day. § 556.770 Zoalene. (b) Tolerances. A tolerance for Tolerances are established for resi- tylvalosin in edible tissues of swine is dues of zoalene (3,5-dinitro-o- not required. toluamide) and its metabolite 3-amino- (c) Related conditions of use. See 5-nitro-o-toluamide in food as follows: §§ 520.2645 and 558.633 of this chapter. (a) In edible tissues of chickens: [77 FR 55415, Sept. 10, 2012, as amended at 81 (1) 6 parts per million in uncooked FR 36789, June 8, 2016] liver and kidney.

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(2) 3 parts per million in uncooked 558.455 Oxytetracycline and neomycin. muscle tissue. 558.464 Poloxalene. (3) 2 parts per million in uncooked 558.465 Poloxalene free-choice liquid Type C fat. feed. (b) In edible tissues of turkeys: 3 558.485 Pyrantel. parts per million in uncooked muscle 558.500 Ractopamine. tissue and liver. 558.515 Robenidine. 558.550 Salinomycin. 558.555 Semduramicin. PART 558—NEW ANIMAL DRUGS 558.575 Sulfadimethoxine and ormetoprim. FOR USE IN ANIMAL FEEDS 558.582 Sulfamerazine. 558.586 Sulfaquinoxaline. Subpart A—General Provisions 558.600 Thiabendazole. Sec. 558.612 Tiamulin. 558.3 Definitions and general considerations 558.618 Tilmicosin. applicable to this part. 558.625 Tylosin. 558.4 Requirement of a medicated feed mill 558.630 Tylosin and sulfamethazine. license. 558.633 Tylvalosin. 558.5 Requirements for liquid medicated 558.635 Virginiamycin. feed. 558.665 Zilpaterol. 558.6 Veterinary feed directive drugs. 558.680 Zoalene.

Subpart B—Specific New Animal Drugs For AUTHORITY: 21 U.S.C. 354, 360b, 360ccc, Use in Animal Feeds 360ccc–1, 371. 558.55 Amprolium. SOURCE: 40 FR 13959, Mar. 27, 1975, unless 558.58 Amprolium and ethopabate. otherwise noted. 558.59 Apramycin. 558.68 Avilamycin. Subpart A—General Provisions 558.76 Bacitracin methylenedisalicylate. 558.78 Bacitracin zinc. § 558.3 Definitions and general consid- 558.95 Bambermycins. erations applicable to this part. 558.115 Carbadox. 558.128 Chlortetracycline. (a) Regulations in this part provide 558.140 Chlortetracycline and for approved uses of drugs and com- sulfamethazine. binations of drugs in animal feeds. Ap- 558.175 Clopidol. proved combinations of such drugs are 558.185 Coumaphos. 558.195 Decoquinate. specifically identified or incorporated 558.198 Diclazuril. by cross-reference. Unless specifically 558.205 Dichlorvos. provided for by the regulations, a com- 558.235 Efrotomycin. bination of two or more drugs is not 558.248 Erythromycin. approved. 558.254 Famphur. (b) The following definitions apply to 558.258 Fenbendazole. terms used in this part: 558.261 Florfenicol. 558.265 Halofuginone hydrobromide. (1) New animal drugs approved for 558.274 Hygromycin B. use in animal feed are placed in two 558.295 Iodinated casein. categories as follows: 558.300 Ivermectin. (i) Category I—These drugs require 558.305 Laidlomycin. no withdrawal period at the lowest use 558.311 Lasalocid. level in each major species for which 558.325 Lincomycin. 558.340 Maduramicin. they are approved or are approved for 558.342 Melengestrol. use only in minor species. 558.348 Mibolerone. (ii) Category II—These drugs require 558.355 Monensin. a withdrawal period at the lowest use 558.360 Morantel tartrate. level for at least one major species for 558.363 Narasin. which they are approved, or are regu- 558.364 Neomycin sulfate. lated on a ‘‘no-residue’’ basis or with a 558.365 Nequinate. 558.366 Nicarbazin. zero tolerance because of carcinogenic 558.415 Novobiocin. concern regardless of whether a with- 558.430 Nystatin. drawal period is required in any spe- 558.450 Oxytetracycline. cies.

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(2) A ‘‘Type A medicated article’’ is from a Category II, Type A medicated intended solely for use in the manufac- article requires a medicated feed mill ture of another Type A medicated arti- license application approved under cle or a Type B or Type C medicated § 515.20 of this chapter. feed. It consists of a new animal (5) A Type B or Type C medicated drug(s), with or without carrier (e.g., feed manufactured from a drug compo- calcium carbonate, rice hull, corn, glu- nent (bulk or ‘‘drum-run’’ (dried crude ten) with or without inactive ingredi- fermentation product)) requires an ap- ents. The manufacture of a Type A plication approved under § 514.105 of medicated article requires an applica- this chapter or an index listing granted tion approved under § 514.105 of this under § 516.151 of this chapter. chapter or an index listing granted (6) A ‘‘veterinary feed directive under § 516.151 of this chapter. (VFD) drug’’ is a drug intended for use (3) A ‘‘Type B medicated feed’’ is in- in or on animal feed which is limited tended solely for the manufacture of by an approved application filed pursu- other medicated feeds (Type B or Type ant to section 512(b) of the Federal C). It contains a substantial quantity Food, Drug, and Cosmetic Act, a condi- of nutrients including vitamins and/or tionally approved application filed pur- minerals and/or other nutritional in- suant to section 571 of the Federal gredients in an amount not less than 25 Food, Drug, and Cosmetic Act, or an percent of the weight. It is manufac- index listing under section 572 of the tured by diluting a Type A medicated Federal Food, Drug, and Cosmetic Act article or another Type B medicated to use under the professional super- feed. The maximum concentration of vision of a licensed veterinarian. Use of animal drug(s) in a Type B medicated animal feed bearing or containing a feed is 200 times the highest continuous VFD drug must be authorized by a law- use level for Category I drugs and 100 ful veterinary feed directive. times the highest continuous use level (7) A ‘‘veterinary feed directive’’ is a for Category II drugs. The term ‘‘high- written (nonverbal) statement issued est continuous use level’’ means the highest dosage at which the drug is ap- by a licensed veterinarian in the course proved for continuous use (14 days or of the veterinarian’s professional prac- more), or, if the drug is not approved tice that orders the use of a VFD drug for continuous use, it means the high- or combination VFD drug in or on an est level used for disease prevention or animal feed. This written statement control. If the drug is approved for authorizes the client (the owner of the multiple species at different use levels, animal or animals or other caretaker) the highest approved level of use would to obtain and use animal feed bearing govern under this definition. The man- or containing a VFD drug or combina- ufacture of a Type B medicated feed tion VFD drug to treat the client’s ani- from a Category II, Type A medicated mals only in accordance with the con- article requires a medicated feed mill ditions for use approved, conditionally license application approved under approved, or indexed by the Food and § 515.20 of this chapter. Drug Administration. (4) A ‘‘Type C medicated feed’’ is in- (8) A ‘‘medicated feed’’ means a Type tended as the complete feed for the ani- B medicated feed as defined in para- mal or may be fed ‘‘top dressed’’ (added graph (b)(3) of this section or a Type C on top of usual ration) on or offered medicated feed as defined in paragraph ‘‘free-choice’’ (e.g., supplement) in con- (b)(4) of this section. junction with other animal feed. It (9) For the purposes of this part, a contains a substantial quantity of nu- ‘‘distributor’’ means any person who trients including vitamins, minerals, distributes a medicated feed containing and/or other nutritional ingredients. It a VFD drug to another person. Such is manufactured by diluting a Type A other person may be another dis- medicated article or a Type B medi- tributor or the client-recipient of a cated feed. A Type C medicated feed VFD. may be further diluted to produce an- (10) An ‘‘animal production facility’’ other Type C medicated feed. The man- is a location where animals are raised ufacture of a Type C medicated feed for any purpose, but does not include

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the specific location where medicated (13) ‘‘Major species’’ means cattle, feed is made. horses, swine, chickens, turkeys, dogs, (11) An ‘‘acknowledgment letter’’ is a and cats. written (nonverbal) communication (14) ‘‘Minor species’’ means animals, provided to a distributor (consignor) other than humans, that are not major from another distributor (consignee). species. An acknowledgment letter must be [51 FR 7392, Mar. 3, 1986, as amended at 52 FR provided either in hardcopy or through 2682, Jan. 26, 1987; 54 FR 51386, Dec. 15, 1989; electronic media and must affirm: 56 FR 19268, Apr. 26, 1991; 64 FR 63206, Nov. 19, (i) That the distributor will not ship 1999; 65 FR 76929, Dec. 8, 2000; 72 FR 69130, Dec. 6, 2007; 80 FR 31733, June 3, 2015; 81 FR such VFD feed to an animal production 57800, Aug. 24, 2016] facility that does not have a VFD, (ii) That the distributor will not ship § 558.4 Requirement of a medicated such VFD feed to another distributor feed mill license. without receiving a similar written ac- (a) A feed manufacturing facility knowledgment letter, and must possess a medicated feed mill li- (iii) That the distributor has com- cense in order to manufacture a Type B plied with the distributor notification or Type C medicated feed from a Cat- requirements of § 558.6(c)(5). egory II, Type A medicated article. (12) A ‘‘combination veterinary feed (b) The manufacture of the following directive (VFD) drug’’ is a combination types of feed are exempt from the renew animal drug (as defined in quired license, unless otherwise speci- § 514.4(c)(1)(i) of this chapter) intended fied: for use in or on animal feed which is (1) Type B or Type C medicated feed limited by an approved application using Category I, Type A medicated ar- filed under section 512(b) of the Federal ticles or Category I, Type B or Type C medicated feeds; and Food, Drug, and Cosmetic Act, a condi- (2) Type B or Type C medicated feed tionally approved application filed using Category II, Type B or Type C under section 571 of the Federal Food, medicated feeds. Drug, and Cosmetic Act, or an index (c) The use of Type B and Type C listing under section 572 of the Federal medicated feeds shall also conform to Food, Drug, and Cosmetic Act to use the conditions of use provided for in under the professional supervision of a subpart B of this part. licensed veterinarian, and at least one (d) This paragraph identifies each of the new animal drugs in the com- drug by category, the maximum level bination is a VFD drug. Use of animal of drug in Type B medicated feeds, and feed bearing or containing a combina- the assay limits for the drug in Type A tion VFD drug must be authorized by a medicated articles and Type B and lawful VFD. Type C medicated feeds, as follows:

CATEGORY I

Assay limits Drug percent 1 Type B maximum (200x) Assay limits percent 1 Type B/C 2 Type A

Amprolium with Ethopabate ...... 94–114 22.75 g/lb (5.0%) ...... 80–120. Avilamycin ...... 90–110 7.3 g/lb (1.6%) ...... 80–110. Bacitracin methylenedisalicylate .. 85–115 25.0 g/lb (5.5%) ...... 70–130. Bacitracin zinc ...... 84–115 5.0 g/lb (1.1%) ...... 70–130. Bambermycins ...... 90–110 800 g/ton (0.09%) ...... 80–120/70–130. Chlortetracycline ...... 85–115 40.0 g/lb (8.8%) ...... 80–115/70–130. Coumaphos ...... 95–115 6.0 g/lb (1.3%) ...... 80–120. Decoquinate ...... 90–105 2.72 g/lb (0.6%) ...... 80–120. Dichlorvos ...... 100–115 33.0 g/lb (7.3%) ...... 90–120/80–130. Diclazuril ...... 90–110 182 g/t (0.02%) ...... 85–115/70–120. Efrotomycin ...... 94–113 1.45 g/lb (0.32%) ...... 80–120. Iodinated casein ...... 85–115 20.0 g/lb (4.4%) ...... 75–125. Laidlomycin propionate potassium 90–110 1 g/lb (0.22%) ...... 90–115/85–115. Lasalocid ...... 95–115 40.0 g/lb (8.8%) ...... Type B (cattle and sheep): 80–120; Type C (all): 75–125. Lincomycin ...... 90–115 20.0 g/lb (4.4%) ...... 80–130. Melengestrol acetate ...... 90–110 10.0 g/ton (0.0011%) ...... 70–120.

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CATEGORY I—Continued

Assay limits Drug percent 1 Type B maximum (200x) Assay limits percent 1 Type B/C 2 Type A

Monensin ...... 85–115 40.0 g/lb (8.8%) ...... Chickens, turkeys, and quail: 75–125; Cattle: 5–10 g/ton 80–120; Cattle: 10– 30 g/ton 85–115; Goats: 20 g/ton 85– 115; Liq. feed: 80–120. Narasin ...... 90–110 7.2 g/lb (1.6%) ...... 85–115/75–125. Nequinate ...... 95–112 1.83 g/lb (0.4%) ...... 80–120. Nystatin ...... 85–125 5.0 g/lb (1.1%) ...... 75–125. Oxytetracycline ...... 90–120 20.0 g/lb (4.4%) ...... 75–125/65–135. Poloxalene ...... 90–110 54.48 g/lb (12.0%) ...... Liq. feed: 85–115. Ractopamine ...... 85–105 2.46 g/lb (0.54%) ...... 80–110/75–125. Salinomycin ...... 90–110 6.0 g/lb (1.3%) ...... 80–120. Semduramicin (as semduramicin 90–110 2.27 g/lb (0.50%) ...... 80–110 sodium). Semduramicin (as semduramicin 90–110 2.27 g/lb (0.50%) ...... 80–120 sodium biomass). Tylosin ...... 80–120 10.0 g/lb (2.2%) ...... 75–125. Tylvalosin ...... 90–110 3.86 g/lb...... 85–115. Virginiamycin ...... 85–115 10.0 g/lb (2.2%) ...... 70–130. Zoalene ...... 92–104 11.35 g/lb (2.5%) ...... 85–115. 1 Percent of labeled amount. 2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make Type C medicated feed.

CATEGORY II

Assay limits Drug percent 1 Type B maximum (100x) Assay limits percent 1 Type B/C 2 Type A

Amprolium ...... 94–114 11.35 g/lb (2.5%) ...... 80–120. Apramycin ...... 88–112 7.5 g/lb (1.65%) ...... 80–120. Carbadox ...... 90–110 2.5 g/lb (0.55%) ...... 75–125. Clopidol ...... 94–106 11.4 g/lb (2.5%) ...... 90–115/80–120. Erythromycin ...... 85–115 4.625 g/lb (1.02%) ...... 75–125. Famphur ...... 100–110 5.5 g/lb (1.21%) ...... 90–115/80–120. Fenbendazole ...... 93–113 8.87 g/lb (1.96%) ...... 75–125. Florfenicol ...... 90–110 9.1 g/lb (2.0%) ...... Swine feed: 85–115 Catfish feed: 80–110. Salmonid feed: 80–110. Halofuginone hydrobromide ...... 90–115 272.0 g/ton (.03%) ...... 75–125. Hygromycin B ...... 90–110 1,200 g/ton (0.13%) ...... 75–125. Ivermectin ...... 95–105 1,180 g/ton (0.13%) ...... 80–110. Maduramicin ammonium ...... 90–110 545 g/ton (.06%) ...... 80–120. Morantel tartrate ...... 90–110 66.0 g/lb (14.52%) ...... 85–115. Neomycin ...... 80–120 20 g/lb (4.4%) ...... 70–125. Oxytetracycline ...... 80–120 20 g/lb (4.4%) ...... 65–135. Neomycin sulfate ...... 80–120 100 g/lb (22.0%) ...... 70–125. Nicarbazin (granular) ...... 90–110 5.675 g/lb (1.25%) ...... 85–115/75–125. Narasin ...... 90–110 5.675 g/lb (1.25%) ...... 85–115/75–125. Nicarbazin (powder) ...... 98–106 5.675 g/lb (1.25%) ...... 85–115/80–120. Novobiocin ...... 85–115 17.5 g/lb (3.85%) ...... 80–120. Pyrantel tartrate ...... 90–110 36 g/lb (7.9%) ...... 75–125. Robenidine ...... 95–115 1.5 g/lb (0.33%) ...... 80–120. Sulfadimethoxine ...... 90–110 Poultry: 5.675 g/lb ...... 80–115/75–125. Fish: 85.1 g/lb ...... Ormetoprim ...... 90–110 Poultry: 3.405 g/lb ...... 80–115. Fish: 17.0 g/lb ...... Sulfamerazine ...... 85–115 18.6 g/lb (4.0%) ...... 85–115. Sulfamethazine ...... 85–115 10.0 g/lb (2.2%) ...... 80–120. Chlortetracycline ...... 85–115 10.0 g/lb (2.2%) ...... 85–125/70–130. Sulfamethazine ...... 85–115 10.0 g/lb (2.2%) ...... 80–120. Tylosin ...... 80–120 10.0 g/lb (2.2%) ...... 75–125. Sulfaquinoxaline ...... 98–106 11.2 g/lb (2.5%) ...... 85–115. Thiabendazole ...... 94–106 45.4 g/lb (10.0%) ...... >7% 85–115; <7% 90–110. Tiamulin hydrogen fumarate ...... 90–115 10 g/lb ...... 90–115/70–130. Tilmicosin ...... 90–110 37.9 g/lb (8.35%) ...... 85–115. Zilpaterol ...... 90–110 680 g/t (0.075%) ...... 80–110/75–115. 1 Percent of labeled amount.

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2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limit, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C medicated feed.

(e) When drugs from both categories liquid feed under field use conditions; are in combination, the Category II re- and quirements will apply to the combina- (2) Data, or a reference to data in an tion drug product. MF, that shows that the drug is physically stable in liquid feed under field [51 FR 7392, Mar. 3, 1986] conditions; or EDITORIAL NOTE: For FEDERAL REGISTER ci- (3) Feed labeling with recirculation tations affecting § 558.4, see the List of CFR or agitation directions as follows: Sections Affected, which appears in the (i) For liquid feeds stored in recircu- Finding Aids section of the printed volume and at www.fdsys.gov. lating tank systems: Recirculate immediately prior to use for not less than § 558.5 Requirements for liquid medi- 10 minutes, moving not less than 1 per- cated feed. cent of the tank contents per minute from the bottom of the tank to the top. (a) What types of liquid medicated feeds Recirculate daily as described even are covered by this section? This section when not used. covers the following types of liquid (ii) For liquid feeds stored in me- medicated feed: chanical, air, or other agitation-type (1) Type B feed that is intended for tank systems: Agitate immediately further manufacture of other medi- prior to use for not less than 10 min- cated feeds (§ 558.3(b)(3)) or: utes, creating a turbulence at the bot- (2) Type C feed that is intended for tom of the tank that is visible at the the following: top. Agitate daily as described even (i) Further manufacture of another when not used. Type C feed, or (e) How are chemical and physical sta- (ii) Top-dressing (adding on top of the bility data to be submitted? The data usual ration) (§ 558.3(b)(4)). must be submitted as follows: (b) How is liquid free-choice medicated (1) Directly in the NADA, feed regulated? Liquid free-choice medi- (2) By a sponsor, or cated feed is covered by this section (3) To an MF that a sponsor may then and by § 510.455. reference in its NADA with written (c) What is required for new animal consent of the MF holder. drugs intended for use in liquid feed? Any (f) What will be stated in the published new animal drug intended for use in approval for a new animal drug intended liquid feed must be approved for such for use in liquid feed? The approval of a use under section 512 of the Federal new animal drug intended for use in Food, Drug, and Cosmetic Act (the act) liquid feed as published in this sub- or index listed under section 572 of the chapter will include the following react. Such approvals under section 512 quirements: of the act must be: (1) The formula and/or specifications (1) An original NADA, of the liquid medicated feed, where the (2) A supplemental NADA, or owner of this information requests (3) An abbreviated NADA. such publication; and/or (d) What are the approval requirements (2) A statement that the approval has under section 512 of the act for new ani- been granted for a proprietary formula mal drugs intended for use in liquid feed? and/or specifications. An approval under section 512 of the (g) When is a medicated feed mill license act for a new animal drug intended for required for the manufacture of a liquid use in liquid feed must contain the fol- medicated feed? An approved medicated lowing information: feed mill license is required for the (1) Data, or a reference to data in a manufacture of the following types of master file (MF), that shows the rel- feeds: evant ranges of conditions under which (1) All liquid medicated feeds that the drug will be chemically stable in contain a Category II drug, and

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(2) Liquid medicated feeds that con- VFD drug or a combination VFD drug tain a Category I drug and use a propri- (a VFD feed or combination VFD feed) etary formula and/or specifications. may be fed to animals only by or upon (h) What measures are in place to pre- a lawful VFD issued by a licensed vet- vent certain drugs, approved for use in erinarian. animal feed or drinking water but not in (2) A VFD feed or combination VFD liquid medicated feed, from being diverted feed must not be fed to animals after to use in liquid feeds? Any product con- the expiration date on the VFD. taining any form of bacitracin, oxytet- (3) Use and labeling of a VFD drug or racycline, or chlortetracycline, in- a combination VFD drug in feed is lim- tended for oral administration via ani- ited to the approved, conditionally ap- mal feed and/or drinking water, and proved, or indexed conditions of use. not approved for use in a liquid medi- Use of feed containing this veterinary cated feed must include in its labeling feed directive (VFD) drug in a manner the following statement: ‘‘FOR USE IN other than as directed on the labeling lll ONLY. NOT FOR USE IN LIQ- (extralabel use) is not permitted. UID MEDICATED FEEDS.’’ The blank (4) All involved parties (the veteri- may be filled in with the words: ‘‘DRY narian, the distributor, and the client) FEEDS’’, ‘‘DRINKING WATER’’, or must retain a copy of the VFD for 2 ‘‘DRY FEEDS AND DRINKING years. The veterinarian must retain WATER’’. the original VFD in its original form (i) Can the labeling provisions of para- (electronic or hardcopy). The dis- graph (h) of this section be waived, and tributor and client copies may be kept how can I apply for a waiver? (1) The la- as an electronic copy or hardcopy. beling provisions of paragraph (h) of (5) All involved parties must make this section may be waived if there is the VFD and any other records speci- evidence to indicate that it is unlikely fied in this section available for inspec- a new animal drug would be used in the tion and copying by FDA upon request. manufacture of a liquid medicated (6) All labeling and advertising for feed. VFD drugs, combination VFD drugs, (2) To obtain a waiver, you must sub- and feeds containing VFD drugs or mit a letter requesting a waiver to the combination VFD drugs must promi- Office of New Animal Drug Evaluation nently and conspicuously display the (HFV–100), Center for Veterinary Medi- following cautionary statement: ‘‘Cau- cine, Food and Drug Administration, tion: Federal law restricts medicated 7500 Standish Pl., Rockville, MD 20855. feed containing this veterinary feed di- (3) The letter must include a copy of rective (VFD) drug to use by or on the the product label; a description of the order of a licensed veterinarian.’’ formulation; and information to estab- (b) Responsibilities of the veterinarian lish that the physical, chemical, or issuing the VFD. (1) In order for a VFD other properties of the new animal to be lawful, the veterinarian issuing drug are such that diversion to use in the VFD must: liquid medicated feed is unlikely. (i) Be licensed to practice veterinary (j) What else do I need to know about medicine; and the labeling provisions of paragraph (h) of (ii) Be operating in the course of the this section? The labeling provisions of veterinarian’s professional practice paragraph (h) of this section may be and in compliance with all applicable implemented without prior approval as veterinary licensing and practice re- provided for in § 514.8(c)(3) of this chap- quirements, including issuing the VFD ter. in the context of a veterinarian-client- [69 FR 30197, May 27, 2004, as amended at 71 patient relationship (VCPR) as defined FR 74785, Dec. 13, 2006; 72 FR 69131, Dec. 6, by the State. If applicable VCPR re- 2007] quirements as defined by such State do not include the key elements of a valid § 558.6 Veterinary feed directive VCPR as defined in § 530.3(i) of this drugs. chapter, the veterinarian must issue (a) General requirements related to vet- the VFD in the context of a valid erinary feed directive (VFD) drugs. (1) VCPR as defined in § 530.3(i) of this Animal feed bearing or containing a chapter.

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(2) The veterinarian must only issue (xiv) An affirmation of intent for a VFD that is in compliance with the combination VFD drugs as described in conditions for use approved, condi- paragraph (6) of this section; and tionally approved, or indexed for the (xv) The veterinarian’s electronic or VFD drug or combination VFD drug. written signature. (3) The veterinarian must ensure that (4) The veterinarian may, at his or the following information is fully and her discretion, enter the following in- accurately included on the VFD: formation on the VFD to more specifi- (i) The veterinarian’s name, address, cally identify the animals authorized and telephone number; to be treated/fed the VFD feed: (ii) The client’s name, business or (i) A more specific description of the home address, and telephone number; location of animals (e.g., by site, pen, (iii) The premises at which the ani- barn, stall, tank, or other descriptor mals specified in the VFD are located; that the veterinarian deems appro- (iv) The date of VFD issuance; priate); (v) The expiration date of the VFD. (ii) The approximate age range of the This date must not extend beyond the animals; expiration date specified in the ap- (iii) The approximate weight range of proval, conditional approval, or index the animals; and listing, if such date is specified. In (iv) Any other information the vet- cases where the expiration date is not erinarian deems appropriate to identify specified in the approval, conditional the animals specified in the VFD. approval, or index listing, the expira- (5) For VFDs intended to authorize tion date of the VFD must not exceed the use of an approved, conditionally 6 months after the date of issuance; approved, or indexed combination VFD (vi) The name of the VFD drug(s); drug that includes more than one VFD (vii) The species and production class drug, the veterinarian must include the of animals to be fed the VFD feed; drug-specific information required in (viii) The approximate number of paragraphs (b)(3)(vi), (ix), (x), and (xi) animals to be fed the VFD feed by the of this section for each VFD drug in expiration date of the VFD. The ap- the combination. proximate number of animals is the po- (6) The veterinarian may restrict tential number of animals of the spe- VFD authorization to only include the cies and production class identified on VFD drug(s) cited on the VFD or may the VFD that will be fed the VFD feed expand such authorization to allow the or combination VFD feed at the speci- use of the cited VFD drug(s) along with fied premises by the expiration date of one or more over-the-counter (OTC) the VFD; animal drugs in an approved, condi- (ix) The indication for which the tionally approved, or indexed combina- VFD is issued; tion VFD drug. The veterinarian must (x) The level of VFD drug in the VFD affirm his or her intent regarding com- feed and duration of use; bination VFD drugs by including one of (xi) The withdrawal time, special in- the following statements on the VFD: structions, and cautionary statements (i) ‘‘This VFD only authorizes the use necessary for use of the drug in con- of the VFD drug(s) cited in this order formance with the approval; and is not intended to authorize the (xii) The number of reorders (refills) use of such drug(s) in combination with authorized, if permitted by the drug any other animal drugs.’’ approval, conditional approval, or (ii) ‘‘This VFD authorizes the use of index listing. In cases where reorders the VFD drug(s) cited in this order in (refills) are not specified on the label- the following FDA-approved, condi- ing for an approved, conditionally ap- tionally approved, or indexed combina- proved, or index listed VFD drug, reor- tion(s) in medicated feed that contains ders (refills) are not permitted; the VFD drug(s) as a component.’’ [List (xiii) The statement: ‘‘Use of feed specific approved, conditionally ap- containing this veterinary feed direc- proved, or indexed combination medi- tive (VFD) drug in a manner other cated feeds following this statement.] than as directed on the labeling (iii) ‘‘This VFD authorizes the use of (extralabel use) is not permitted.’’; the VFD drug(s) cited in this order in

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any FDA-approved, conditionally ap- per distributor and must include the proved, or indexed combination(s) in following information: medicated feed that contains the VFD (i) The distributor’s complete name drug(s) as a component.’’ and business address; (7) The veterinarian must issue a (ii) The distributor’s signature or the written (nonverbal) VFD. signature of the distributor’s author- (8) The veterinarian must send a copy ized agent; and of the VFD to the distributor via (iii) The date the notification was hardcopy, facsimile (fax), or electroni- signed. cally. If in hardcopy, the veterinarian (6) A distributor must also notify must send the copy of the VFD to the FDA within 30 days of any change in distributor either directly or through ownership, business name, or business the client. address. (9) The veterinarian must provide a (7) The notifications cited in para- copy of the VFD to the client. graphs (c)(5) and (c)(6) of this section (c) Responsibilities of any person who must be submitted to the Food and distributes an animal feed containing a Drug Administration, Center for Vet- VFD drug or a combination VFD drug. (1) erinary Medicine, Division of Animal The distributor is permitted to fill a Feeds (HFV–220), 7519 Standish Pl., VFD only if the VFD contains all the Rockville, MD 20855, FAX: 240–453–6882. information required in paragraph (8) A distributor is permitted to dis- (b)(3) of this section. tribute a VFD feed to another dis- (2) The distributor is permitted to tributor only if the originating dis- distribute an animal feed containing a tributor (consignor) first obtains a VFD drug or combination VFD drug written (nonverbal) acknowledgment only if it complies with the terms of letter, as defined in § 558.3(b)(11), from the VFD and is manufactured and la- the receiving distributor (consignee) beled in conformity with the approved, before the feed is shipped. Consignor conditionally approved, or indexed con- distributors must retain a copy of each ditions of use for such drug. consignee distributor’s acknowledg- (3) The distributor must keep records ment letter for 2 years. of the receipt and distribution of all medicated animal feed containing a [80 FR 31733, June 3, 2015; 80 FR 35841, June 23, 2015] VFD drug for 2 years. (4) In addition to other applicable recordkeeping requirements found in Subpart B—Specific New Animal this section, if the distributor manu- Drugs for Use in Animal Feeds factures the animal feed bearing or containing the VFD drug, the dis- § 558.55 Amprolium. tributor must also keep VFD feed man- (a) Approvals. Type A medicated arti- ufacturing records for 1 year in accord- cles: 25 percent to No. 016592 in ance with part 225 of this chapter. Such § 510.600(c) of this chapter for use as in records must be made available for in- paragraph (d) of this section. spection and copying by FDA upon re- (b) Special considerations. Do not use quest. in Type B or Type C medicated feeds (5) A distributor of animal feed con- containing bentonite. taining a VFD drug must notify FDA (c) Related tolerances. See § 556.50 of prior to the first time it distributes this chapter. animal feed containing a VFD drug. (d) Conditions of use—(1) Cattle. It is The notification is required one time used as follows:

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Amprolium in grams per ton Indications for use Limitations Sponsor

(i) 113.5 to 11, 350; to Calves: As an aid in the prevention of coc- Top-dress on or mix in the daily ration. Feed 016592 provide 5 milligrams cidiosis caused by Eimeria bovis and E. for 21 days when experience indicates per kilogram of zuernii. that coccidiosis is likely to be a hazard, as body weight per the sole source of amprolium. Withdraw day. 24 hours before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. (ii) 113.5 to 11, 350; Calves: As an aid in the treatment of coc- Top-dress on or mix in the daily ration. Feed 016592 to provide 10 milli- cidiosis caused by Eimeria bovis and E. for 5 days as the sole source of grams per kilogram zuernii. amprolium. Withdraw 24 hours before of body weight per slaughter. A withdrawal period has not day. been established for this product in preruminating calves. Do not use in calves to be processed for veal.

(2) Chickens. It is used as follows:

Amprolium in grams Combination in per ton grams per ton Indications for use Limitations Sponsor

(i) 36.3 to 113.5 ...... Replacement chickens: For devel- Feed continuously until onset of 016592 opment of active immunity to production as follows: coccidiosis.

Up to 5 weeks of age From 5 to 8 weeks of Over 8 weeks of age age Growing conditions Amprolium in grams Amprolium in grams Amprolium in grams per ton per ton per ton

Severe exposure to coccidiosis ...... 113.5 72.6–113.5 36.3–113.5 (0.0125%) (0.008%–0.0125%) (0.004%–0.0125%) Moderate exposure to coccidiosis ...... 72.6–113.5 54.5–113.5 36.3–113.5 (0.008%–0.0125%) (0.006%–0.0125%) (0.004%–0.0125%) Slight exposure to coccidiosis ...... 36.3–113.5 36.3–113.5 36.3–113.5 (0.004%–0.0125%) (0.004%–0.0125%) (0.004%–0.0125%)

Amprolium in grams Combination in per ton grams per ton Indications for use Limitations Sponsor

(ii) 36.3 to 113.5 ..... Bacitracin Replacement chickens: For devel- Feed according to subtable in 054771 methylenedisalicy- opment of active immunity to item (i). Bacitracin late 4 to 50. coccidiosis; and for increased methylenedisalicylate as pro- rate of weight gain and im- vided by No. 054771 in proved feed efficiency. § 510.600(c) of this chapter. (iii) 72.6 to 113.5 ...... Broiler chickens: For prevention Feed continuously as the sole ra- 016592 of coccidiosis caused by tion; as sole source of Eimeria tenella only. amprolium. (iv) 72.6 to 113.5 .... Bambermycins 1 to Broiler chickens: For prevention Feed continuously as the sole ra- 016592 2. of coccidiosis caused by tion; as sole source of Eimeria tenella only; and for in- amprolium. Bambermycins as creased rate of weight gain and provided by No. 016592 in improved feed efficiency. § 510.600(c) of this chapter. (v) 113.5 ...... 1. Laying chickens: For preven- Feed continuously as the sole ra- 016592 tion of coccidiosis. tion; as the sole source of amprolium. 2. Laying chickens: For treatment Feed for 2 weeks. of coccidiosis in moderate outbreaks. (vi) 113.5 to 227 ...... 1. Replacement chickens: For Feed continuously from day-old 016592 prevention of coccidiosis where until onset of production; as the immunity to coccidiosis is not sole source of amprolium. desired. 2. Broiler chickens: For preven- Feed continuously as the sole ration of coccidiosis where immu- tion; as sole source of nity to coccidiosis is not desired. amprolium.

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Amprolium in grams Combination in per ton grams per ton Indications for use Limitations Sponsor

(vii) 113.5 to 227 .... Bambermycins 1 to Broiler chickens: For prevention Feed continuously as the sole ra- 016592 2. of coccidiosis where immunity tion; as sole source of to coccidiosis is not desired; amprolium. Bambermycins as and for increased rate of weight provided by No. 016592 in gain and improved feed effi- § 510.600(c) of this chapter. ciency. (viii) 227 ...... Laying chickens: For treatment of Feed for 2 weeks ...... 016592 coccidiosis in severe outbreaks..

(3) Turkeys. It is used as follows:

Amprolium in grams Combination in per ton grams per ton Indications for use Limitations Sponsor

(i) 113.5 ...... Bambermycins 1 to Growing turkeys: For prevention Feed continuously as the sole 016592 4. of coccidiosis; and for in- source of amprolium; creased rate of weight gain and bambermycins as provided by improved feed efficiency. No. 016592 in § 510.600(c) of this chapter. (ii) 113.5 to 227 ...... Turkeys: For prevention of coc- Feed continuously as the sole ra- 016592 cidiosis. tion; as sole source of amprolium.

(4) Pheasants. It is used as follows:

Amprolium in grams Combination in per ton grams per ton Indications for use Limitations Sponsor

(i) 159 ...... Growing pheasants: For the pre- Feed continuously as sole ration. 016592 vention of coccidiosis caused Use as sole source of by Eimeria colchici, E. amprolium. duodenalis, and E. phasiani. (ii) [Reserved]

[41 FR 10985, Mar. 15, 1976] (2) 25 percent amprolium and 0.8 per- EDITORIAL NOTE: For FEDERAL REGISTER ci- cent ethopabate or 5 percent tations affecting § 558.55, see the List of CFR amprolium and 0.16 percent Sections Affected, which appears in the ethopabate. Finding Aids section of the printed volume (b) Approvals. See No. 016592 in and at www.fdsys.gov. § 510.600(c) of this chapter. (c) Special considerations. Do not use § 558.58 Amprolium and ethopabate. in Type B or Type C medicated feeds (a) Specifications. Type A medicated containing bentonite. articles containing: (d) Related tolerances. See §§ 556.50 and (1) 25 percent amprolium and 8 per- 556.260 of this chapter. cent ethopabate or 5 percent (e) Conditions of use. It is used in amprolium and 1.6 percent ethopabate; chicken feed as follows:

Amprolium and ethopabate in grams Combination in Indications for use Limitations Sponsor per ton grams per ton

(1) Amprolium 113.5 ...... Broiler chickens: As an aid in the Feed continuously as sole ration; 016592 and ethopabate prevention of coccidiosis. as sole source of amprolium. 3.6. Not for laying chickens. (2) [Reserved].

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Amprolium and ethopabate in grams Combination in Indications for use Limitations Sponsor per ton grams per ton

(3) Amprolium 113.5 ...... Broiler chickens and replacement Feed continuously as sole ration; 016592 and ethopabate chickens: where immunity to as sole source of amprolium. 36.3. coccidiosis is not desired: As Not for chickens over 16 weeks an aid in the prevention of coc- of age. cidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur. (4) Amprolium 113.5 Bacitracin 4 to 50 ... 1. Broiler chickens and replace- Feed as the sole ration from the 016592 and ethopabate ment chickens: where immunity time chickens are placed on lit- 36.3. to coccidiosis is not desired; to ter until past the time when aid in prevention of coccidiosis coccidiosis is ordinarily a haz- where severe exposure to coc- ard. Not for chickens over 16 cidiosis from Eimeria weeks of age; do not feed to acervulina, E. maxima, and E. laying chickens; as sole source brunetti is likely to occur; for in- of amprolium; not for use as a creased rate of weight gain in treatment for outbreaks of coc- broiler chickens raised in floor cidiosis. Bacitracin as bacitracin pens. methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. (5) Amprolium 113.5 Bacitracin 4 to 50 ... 2. Broiler chickens: As an aid in Feed as the sole ration from the 054771 and ethopabate prevention of coccidiosis where time chickens are placed on lit- 36.3. severe exposure to coccidiosis ter until market weight. Not for from Eimeria acervulina, E. chickens over 16 weeks of age; maxima, and E. brunetti is likely do not feed to laying chickens; to occur; for improved feed effi- as sole source of amprolium; ciency. not for use as a treatment for coccidiosis. Bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter. (6) Amprolium 113.5 Bambermycins 1 to Broiler chickens: As an aid in the Feed continuously as the sole ra- 016592 and ethopabate 3. prevention of coccidiosis where tion; as sole source of 36.6. severe exposure to coccidiosis amprolium. from Eimeria acervulina, E. Bambermycins as provided by maxima, and E. brunetti is likely No. 016592 in § 510.600(c) of to occur; for increased rate of this chapter. weight gain, improved feed efficiency. (7)–(8) [Reserved]. (9) Amprolium 227 ...... For broiler chickens and replace- Not for laying chickens ...... 016592 and ethopabate ment chickens where immunity 3.6. to coccidiosis is not desired; prevention of coccidiosis.

(f) Amprolium and ethopabate may § 558.59 Apramycin. also be used in combination with: (1)–(2) [Reserved] (a) Specifications. Type A articles con- (3) Chlortetracycline as in § 558.128. taining 75 grams apramycin (as apramycin sulfate) per pound. [41 FR 10990, Mar. 15, 1976] (b) Sponsor. See No. 058198 in EDITORIAL NOTE: For FEDERAL REGISTER ci- § 510.600(c) of this chapter. tations affecting § 558.58, see the List of CFR (c) Related tolerances. See § 556.52 of Sections Affected, which appears in the this chapter. Finding Aids section of the printed volume and at www.fdsys.gov. (d) Conditions of use in swine—

Apramycin Combination in grams/ton grams/ton Indications for use Limitations Sponsor

(1) 150...... For control of porcine colibacillosis Feed as the sole ration for 058198 (weanling pig scours) caused by sus- 14 consecutive days. ceptible strains of Escherichia coli. Withdraw 28 days before slaughter. (2) [Reserved].

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[81 FR 94995, Dec. 27, 2016] this veterinary feed directive (VFD) drug to use by or on the order of a li- § 558.68 Avilamycin. censed veterinarian. See § 558.6 for addi- (a) Each pound of Type A medicated tional requirements. article contains 45.4 or 90.7 grams of (2) The expiration date of VFDs for avilamycin. avilamycin medicated feeds must not (b) Sponsor. See No. 058198 in exceed 90 days from the date of § 510.600(c) of this chapter. issuance. VFDs for avilamycin shall (c) Related tolerances. See § 556.68 of not be refilled. this chapter. (e) Conditions of use. Administer in (d) Special considerations—(1) Federal feed as follows: law restricts medicated feed containing (1) Chickens—

Avilamycin in Combination in grams/ton grams/ton Indications for use Limitations Sponsor

(i) 13.6 to 40.9 ...... Broiler chickens: For the preven- Feed as the sole ration for 21 con- 058198 tion of mortality caused by ne- secutive days. To assure re- crotic enteritis associated with sponsible antimicrobial drug use Clostridium perfringens in broiler in broiler chickens, treatment ad- chickens. ministration must begin on or before 10 days of age. (ii) 13.6 to 40.9 ..... Monensin 90 Broiler chickens: For the preven- Feed as the sole ration for 21 con- 058198 to 110; as tion of mortality caused by ne- secutive days. To assure re- provided by crotic enteritis associated with sponsible antimicrobial drug use No. 058198 in Clostridium perfringens in broiler in broiler chickens, treatment ad- § 510.600(c) of chickens; and as an aid in the ministration must begin on or this chapter prevention of coccidiosis caused before 10 days of age. See by Eimeria necatrix, E. tenella, § 558.355(d) of this chapter for E. acervulina, E. brunetti, E. additional required labeling. mivati, and E. maxima.

(2) Swine—

Avilamycin in Combinationin grams/ton grams/ton Indications for use Limitations Sponsor

(i) 73 ...... Weaned pigs less than 14 weeks Feed as the sole ration for 21 con- 058198 of age: For the reduction in inci- secutive days. To assure re- dence and overall severity of di- sponsible antimicrobial drug use arrhea in the presence of patho- in pigs, do not administer to pigs genic Escherichia coli in groups 14 weeks of age or older. of weaned pigs. (ii) [Reserved].

[80 FR 61297, Oct. 13, 2015, as amended at 80 (1) No. 054771 for use of products in FR 76387, Dec. 9, 2015; 81 FR 17609, Mar. 30, paragraph (a)(1) of this section as in 2016; 81 FR 48703, July 26, 2016; 81 FR 59134, paragraphs (e)(1)(i), (e)(1)(iii), (e)(1)(v) Aug. 29, 2016; 81 FR 67152, Sept. 30, 2016; 82 FR through (xiii), and (e)(1)(xv) of this sec- 11509, Feb. 24, 2017] tion. (2) No. 069254 for use of products in § 558.76 Bacitracin paragraph (a)(2) of this section as in methylenedisalicylate. paragraphs (e)(1)(ii), (e)(1)(iv), (a) Specifications. (1) Type A medi- (e)(1)(xiv), and (e)(1)(xvi) of this sec- cated articles containing 10, 25, 30, 40, tion. 50, 60, or 75 grams bacitracin (c) Special considerations. The quan- methylenedisalicylate per pound. tities of antibiotics are expressed in (2) Type A medicated article con- terms of the equivalent amount of an- taining 50 grams bacitracin tibiotic standard. methylenedisalicylate per pound. (d) Related tolerances. See § 556.70 of (b) Sponsors. See sponsors in this chapter. § 510.600(c) of this chapter: (e) Conditions of use. (1) It is used as follows:

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Bacitracin Combination in methylenedisalicylate grams per ton Indications for use Limitations Sponsor amount (g/ton)

(i) 4 to 50 g/ton ...... Chickens, turkeys, and pheas- ...... 054771 ants: For increased rate of weight gain and improved feed efficiency. (ii) 4 to 50 g/ton ...... Broiler and replacement chick- ...... 069254 ens, growing turkeys, and growing pheasants: For increased rate of weight gain and improved feed efficiency. (iii) 5 to 20 g/ton ...... Quail not over 5 weeks of age: ...... 054771 For increased rate of weight gain and improved feed efficiency. (iv) 5 to 20 g/ton ...... Growing quail: For increased For use in quail not over 5 069254 rate of weight gain and im- weeks of age. proved feed efficiency. (v) 10 to 25 g/ton ...... Chickens: For increased egg For first 7 months of production 054771 production and improved feed efficiency for egg production. (vi) 10 to 30 g/ton ...... Swine: For increased rate of For growing and finishing swine 054771 weight gain and improved feed efficiency. (vii) [Reserved]. (viii) 10 to 30 g/ton ...... Swine: For control of porcine Feed for not more than 14 days; 054771 proliferative enteropathies (ilei- chlortetracycline and baci- tis) caused by Lawsonia tracin methylenedisalicylate as intracellularis susceptible to provided by No. 054771 in chlortetracycline. § 510.600(c) of this chapter. (ix) 50 g/ton ...... Broiler chickens: As an aid in Feed continuously as sole ration 054771 the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Replacement chickens: As an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. (x) 100 to 200 g/ton...... Broiler chickens: As an aid in Feed continuously as sole ra- 054771 the control of necrotic enteritis tion. Start at first clinical signs caused or complicated by of disease, vary dosage based Clostridium spp. or other orga- on severity of infection, admin- nisms susceptible to baci- ister continuously for 5 to 7 tracin. Replacement chickens: days or as long as clinical As an aid in the control of ne- signs persist, then reduce crotic enteritis caused or com- medication to prevention level plicated by Clostridium spp. or (50 g/ton). other organisms susceptible to bacitracin. (xi) 200 g/ton ...... Turkeys: As an aid in the control Feed continuously as the sole 054771 of transmissible enteritis in ration. growing turkeys complicated by organisms susceptible to bacitracin methylenedisalicylate. Quail: For the prevention of ulcerative enteritis in growing quail due to Clostridium colinum susceptible to bacitracin methylenedisalicylate. (xii) 250 g/ton ...... 1. Growing/finishing swine: For As the sole ration. Not for use in 054771 control of swine dysentery swine weighing more than 250 Treponema hyodysenteriae on pounds. Diagnosis should be premises with history of swine confirmed by a veterinarian a dysentery but where signs of when results are not satisfac- the disease have not yet oc- tory. curred; or following an approved treatment of the disease condition.

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Bacitracin Combination in methylenedisalicylate grams per ton Indications for use Limitations Sponsor amount (g/ton)

2. Pregnant sows: For control of As the sole ration. Feed to sows clostridial enteritis caused by from 14 days before through C. perfringens in suckling pig- 21 days after farrowing on lets. premises with a history of clostridial scours. Diagnosis should be confirmed by veterinarian when results are not satisfactory. (xiii) To provide 70 mg ...... Feedlot beef cattle: For reduc- Administer continuously through- 054771 per head per day. tion in the number of liver con- out the feeding period. demnations due to abscesses. (xiv) To provide 70 ...... Beef steers and heifers fed in Administer continuously through- 069254 mg per head per confinement for slaughter: For out the feeding period. day. reduction in the number of liver condemnations due to abscesses. (xv) To provide 250 ...... Feedlot beef cattle: For reduc- Administer continuously for 5 054771 mg per head per tion in the number of liver con- days then discontinue for sub- day. demnations due to abscesses. sequent 25 days, repeat the pattern during the feeding period. (xvi) To provide 250 ...... Beef steers and heifers fed in Administer continuously for 5 069254 mg per head per confinement for slaughter: For days then discontinue for sub- day. reduction in the number of sequent 25 days, repeat the liver condemnations due to pattern during the feeding pe- abscesses. riod.

(2) Bacitracin methylenedisalicylate EDITORIAL NOTES 1. For FEDERAL REGISTER may also be used in combination with: citations affecting § 558.76, see the List of (i) Amprolium as in § 558.55. CFR Sections Affected, which appears in the (ii) Amprolium and ethopabate as in Finding Aids section of the printed volume § 558.58. and at www.fdsys.gov. (iii) Chlortetracycline as in § 558.128. 2. At 80 FR 78970, Dec. 18, 2015, § 558.76 was (iv) Clopidol as in § 558.175. amended by removing and reserving para- (v) Decoquinate as in § 558.195. graph (d)(3)(xiii); however, the amendment (vi) Diclazuril as in § 558.198. could not be incorporated because the para- (vii) Fenbendazole as in § 588.258. graph did not exist. (viii) Halofuginone hydrobromide as in § 558.265. § 558.78 Bacitracin zinc. (ix) Ivermectin as in § 558.300. (a) Specifications. Type A medicated (x) Lasalocid as in § 558.311. articles containing bacitracin zinc (xi) Monensin as in § 588.355. equivalent to 10, 25, 40, or 50 grams per (xii) Narasin as in § 558.363. pound bacitracin. (xiii) Nicarbazin alone and with (b) Approvals. See No. 054771 in narasin as in § 558.366. § 510.600(c) of this chapter. (xiv) Robenidine as in § 558.515. (xv) Salinomycin as in § 558.550. (c) Related tolerances. See § 556.70 of (xvi) Semduramicin as in § 558.555. this chapter. (xvii) Zoalene as in § 558.680. (d) Conditions of use. (1) It is used as follows: [41 FR 10993, Mar. 15, 1976]

Bacitracin zinc in Combinations in grams per ton grams per ton Indications for use Limitations Sponsor

(i) 4 to 50 ...... Chickens: for increased rate of Growing chickens ...... 054771 weight gain and improved feed efficiency. (ii) 4 to 50 ...... Turkeys and pheasants: for in- Growing turkeys and pheasants 054771 creased rate of weight gain and improved feed efficiency. (iii) 5 to 20...... Quail; for increased rate of Growing quail; feed as the Type 054771 weight gain and improved C feed to starting quail feed efficiency. through 5 weeks of age.

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Bacitracin zinc in Combinations in grams per ton grams per ton Indications for use Limitations Sponsor

(iv) 10 to 25 ...... Laying chickens; improved feed ...... 054771 efficiency and increased egg production. (v) 10 to 50 ...... Swine; increased rate of weight Growing and finishing swine ...... 054771 gain and improved feed efficiency. (vi) 20...... Growing-finishing swine; in- In Type C feed ...... 054771 creased rate of weight gain. (vii) 20 to 40 ...... Growing-finishing swine; im- ...... do ...... 054771 proved feed efficiency.

(2) It is used in feed for growing cat- § 558.95 Bambermycins. tle at 35 to 70 milligrams per head per (a) Approvals. See sponsors in day as follows: § 510.600(c) of this chapter for use of (i) To aid in stimulating growth and Type A medicated articles as in para- improving feed efficiency. graph (d) of this section: (ii) For increased rate of weight gain (1) No. 016592: 2, 4, and 10 grams per and improved feed efficiency; see spon- pound for use as in paragraphs (d)(1), sor 054771. (d)(2), (d)(3), and (d)(4) of this section. (3) Bacitracin zinc may also be used (2) No. 012286: 2 grams for use as in in combination with: paragraph (d)(2) of this section and 0.4 (i) Amprolium and ethopabate as in and 2 grams per pound for use as in § 558.58. paragraph (d)(3). (ii) Clopidol as in § 558.175. (b) Special considerations. (1) (iii) Decoquinate as in § 558.195. Bambermycins liquid Type B feeds may be manufactured from dry (iv) Lasalocid as in § 558.311. bambermycins Type A articles. The (v) Monensin as in § 558.355. liquid Type B feeds must have a pH of (vi) Naracin as in § 558.363. 3.8 to 7.5, moisture content of 30 to 45 (vii) [Reserved] percent. (viii) Robenidine as in § 558.515. (2) The expiration date for the liquid (ix) Salinomycin as in § 558.550. Type B feed is 8 weeks after date of manufacture. The expiration date for [41 FR 10994, Mar. 15, 1976] the dry Type C feed made from the liq- EDITORIAL NOTE: For FEDERAL REGISTER ci- uid Type B feed is 1 week after date of tations affecting § 558.78, see the List of CFR manufacture. Sections Affected, which appears in the (c) [Reserved] Finding Aids section of the printed volume (d) Conditions of use—(1) Chickens. Use and at www.fdsys.gov. in medicated feed as follows:

Bambermycins in grams/ton Indications for use Limitations Sponsor

(i) 1 to 2 ...... Broiler chickens: For increased Feed continuously as the sole 016592. rate of weight gain and im- ration. proved feed efficiency. (ii) [Reserved].

(2) Turkeys. Use in medicated feed as follows:

Bambermycins in grams/ton Indications for use Limitations Sponsor

(i) 1 to 2 ...... Growing turkeys: For improved Feed continuously as the sole 012286, 016592. feed efficiency. ration. (ii) 2 ...... Growing turkeys: For in- Feed continuously as the sole 012286, 016592. creased rate of weight gain ration. and improved feed efficiency.

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(3) Swine. Use in medicated feed as follows:

Bambermycins in grams/ton Indications for use Limitations Sponsor

(i) 2 ...... Growing-finishing swine: For Feed continuously as the sole 012286, 016592. increased rate of weight ration. gain and improved feed efficiency. (ii) 2 to 4 ...... Growing-finishing swine: For Feed continuously as the sole 012286, 016592. increased rate of weight. ration.

(4) Cattle.

Bambermycins in grams/ton Indications for use Limitations Sponsor

(i) 1 to 4 ...... Cattle fed in confinement for Feed continuously at a rate of 016592. slaughter: For increased 10 to 20 milligrams per head rate of weight gain and imper day. proved feed efficiency. (ii) 2 to 80 ...... Pasture cattle (slaughter, Feed continuously on a hand- 016592. stocker, and feeder cattle, fed basis at a rate of 10 to and dairy and beef replace- 40 milligrams per head per ment heifers): For increased day in 1 to 10 pounds of rate of weight gain. supplemental Type C medicated feed.

(iii) Used as a free-choice Type C feeder cattle; and beef replacement medicated loose-mineral feed for pas- heifers) as follows: ture cattle (slaughter, stocker, and (a) Specifications.

Ingredient International Feed No. Percent

Deflorinated phosphate (20.5% calcium, 18.5% phosphorus) ...... 6–01–080 ...... 42.50 Sodium chloride (salt) ...... 6–04–152 ...... 20.10 Calcium carbonate (38% calcium) ...... 6–01–069 ...... 15.24 Corn distillers dried grains w/solubles ...... 5–28–236 ...... 9.57 Magnesium oxide ...... 6–02–756 ...... 5.15 Vitamin and trace mineral premix * ...... 3.72 Mineral oil ...... 1.00 Yeast (primary dehydrated yeast) ...... 7–05–533 ...... 0.75 Bambermycins Type A article (10 g/lb) ...... 0.60 Iron oxide ...... 6–02–431 ...... 0.50 Magnesium sulfate (67%) ...... 6–02–758 ...... 0.32 Selenium premix (270 mg/lb) * ...... 0.21 Copper sulfate ...... 6–01–720 ...... 0.18 Potassium sulfate (0.33%) ...... 6–06–098 ...... 0.16 *Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free- choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).

(b) Amount per ton. 120 grams. in excess of 20 mg/head/day have not (c)Indications for use. For increased been shown to be more effective than 20 rate of weight gain. mg/head/day. (d) Limitations. For free-choice feed- (iv) Use free-choice Type C medicated ing to pasture cattle (slaughter, stock- feeds for pasture cattle (slaughter, er, and feeder cattle; and beef replace- stocker, and feeder cattle; and beef re- ment heifers). Feed a nonmedicated placement heifers) as follows: commercial mineral product for 6 (a) Amount. Feed continuously to pro- weeks to stabilize consumption be- vide 10 to 40 milligrams of tween 2.66 and 10.66 ounces per head per bambermycins per head per day. day. Feed continuously to provide 10 to (b) Indications for use. For increased 40 milligrams bambermycins per head rate of weight gain. per day. Daily bambermycins intakes

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(c) Limitations. Each use in a free- shown to be more effective than 20 mg/ choice Type C medicated feed must be head/day. the subject of an approved new animal (v) Used as a free-choice Type C drug application (NADA) or supple- medicated loose mineral feed for pas- mental NADA as required by 21 CFR ture cattle (slaughter, stocker, and 510.455. Daily bambermycins intakes in feeder cattle; and dairy and beef re- excess of 20 mg/head/day have not been placement heifers) as follows: (A) Specifications.

Ingredient International Feed No. Percent

Deflorinated phosphate (20.5% calcium, 18.5% phosphorus) ...... 6–01–080 ...... 42.50 Sodium chloride (salt) ...... 6–04–152 ...... 20.10 Calcium carbonate (38% calcium) ...... 6–01–069 ...... 15.45 Corn distillers dried grains w/solubles ...... 5–28–236 ...... 9.57 Magnesium oxide ...... 6–02–756 ...... 5.15 Vitamin and trace mineral premix * ...... 3.72 Mineral oil ...... 1.00 Yeast (primary dehydrated yeast) ...... 7–05–533 ...... 0.75 Bambermycins Type A article (10 g/lb) ...... 0.60 Iron oxide ...... 6–02–431 ...... 0.50 Magnesium sulfate (67%) ...... 6–02–758 ...... 0.32 Copper sulfate ...... 6–01–720 ...... 0.18 Potassium sulfate (0.33%) ...... 6–06–098 ...... 0.16 * Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free- choice feeds. Formulation modifications require FDA approval prior to marketing. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).

(B) Amount per ton. 120 grams. Sections Affected, which appears in the (C) Indications for use. For increased Finding Aids section of the printed volume rate of weight gain. and at www.fdsys.gov. (D) Limitations. For free-choice feeding to pasture cattle (slaughter, stock- § 558.115 Carbadox. er, and feeder cattle; and dairy and beef (a) Approvals. Type A medicated arti- replacement heifers). Feed a non-medi- cles: 2.2. percent (10 grams per pound) cated commercial mineral product for 6 to 066104 in § 510.600(c) of this chapter. weeks to stabilize consumption be- (b) Related tolerances. See § 556.100 of tween 2.66 and 10.66 ounces per head per this chapter. day. Feed continuously to provide 10 to (c) Special considerations. Do not use 40 milligrams bambermycins per head in Type B or Type C medicated feeds per day. Daily bambermycins intakes containing bentonite. in excess of 20 mg/head/day have not (d) Conditions of use. It is used for been shown to be more effective than 20 swine as follows: mg/head/day. (1) Amount per ton. 10–25 grams (5) Bambermycins may also be used (0.0011–0.00275 percent). in combination with: (i) Indications for use. For increase in (i) Amprolium as in § 558.55. rate of weight gain and improvement of (ii) Amprolium and ethopabate as in feed efficiency. § 558.58. (ii) Limitations. Not for use in preg- (iii) Clopidal as in § 558.175. nant swine or swine intended for breed- (iv) Diclazuril as in § 558.198. ing purposes. Do not feed to swine (v) Halofuginone as in § 558.265. within 42 days of slaughter. (vi) Lasalocid as in § 558.311. (2) Amount per ton. 50 grams (0.0055 (vii) Monensin as in § 558.355. percent). (viii) Narasin alone or with nicarbazin as in § 558.363. (i) Indications for use. For control of (ix) Nicarbazin as in § 558.366. swine dysentery (vibrionic dysentery, (x) Salinomycin as in § 558.550. bloody scours, or hemorrhagic dys- (xi) Zoalene as in § 558.680. entery); control of bacterial swine enteritis (salmonellosis or necrotic enter- [40 FR 13959, Mar. 27, 1975] itis caused by Salmonella choleraesuis); EDITORIAL NOTE: For FEDERAL REGISTER ci- increased rate of weight gain and im- tations affecting § 558.95, see the List of CFR proved feed efficiency.

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(ii) Limitations. Not for use in preg- (b) Approvals. See sponsors in nant swine or swine intended for breed- § 510.600(c) of this chapter for use as in ing purposes. Do not feed to swine paragraph (e) of this section. within 42 days of slaughter. (1) Nos. 054771: 50, 90, or 100 grams per (3) Amount per ton. Carbadox 50 grams pound (g/lb) Type A medicated article. (0.0055 percent) plus pyrantel tartrate, (2) No. 066104: 10, 20, 30, 50, 70, or 100 96 grams (0.0106 percent). g/lb of Type A medicated article. (i) Indications for use. For control of (3) No. 069254: 50, 90, or 100 g/lb of swine dysentery (vibrionic dysentery, Type A medicated article. bloody scours, or hemorrhagic dys- (c) Related tolerances. See § 556.150 of entery); control of bacterial swine en- this chapter. teritis (salmonellosis or necrotic enter- (d) Special considerations. (1) Federal itis caused by Salmonella choleraesuis); law restricts medicated feed containing aid in the prevention of migration and this veterinary feed directive (VFD) establishment of large roundworm drug to use by or on the order of a li- (Ascaris suum) infections; aid in the censed veterinarian. See § 558.6 for addi- prevention of establishment of nodular tional requirements. worm (Oesophagostomum) infections. (2) The expiration date of VFDs for (ii) Limitations. Do not feed to swine over 75 pounds; do not feed within 10 chlortetracycline medicated feeds must weeks of slaughter; consult a veteri- not exceed 6 months from the date of narian before feeding to severely de- issuance. VFDs for chlortetracycline bilitated animals; feed continuously as shall not be refilled. sole ration. Do not use in complete (3) In milk replacers or starter feed; feeds containing less than 15 percent include on labeling the warning: ‘‘A crude protein. withdrawal period has not been estab- (4) Carbadox may also be used in lished for this product in combination with oxytetracycline as in preruminating calves. Do not use in § 558.450. calves to be processed for veal.’’ (4) Manufacture for use in free-choice [40 FR 13959, Mar. 27, 1975, as amended at 40 feeds as in paragraph (e)(4)(iii) of this FR 45164, Oct. 1, 1975; 40 FR 57798, Dec. 12, section must conform to § 510.455 of this 1975; 42 FR 761, Jan. 4, 1977; 51 FR 7396, Mar. 3, 1986; 63 FR 59216, Nov. 3, 1998; 66 FR 47963, chapter. Sept. 17, 2001; 69 FR 51173, Aug. 18, 2004; 82 FR (5) When manufactured for use as in 21691, May 10, 2017] paragraph (e)(5)(iii) of this section, include on labeling the warning: ‘‘Psit- § 558.128 Chlortetracycline. tacosis, avian chlamydiosis, or orni- (a) Specifications. Type A medicated thosis is a reportable communicable articles containing either chlortetra- disease, transmissible between wild and cycline calcium complex equivalent to domestic birds, other animals, and chlortetracycline hydrochloride, or for man. Contact appropriate public health products intended for use in milk re- and regulatory officials.’’ placer, chlortetracycline hydro- (e) Conditions of use—(1) Chickens. It chloride. is used as follows:

Chlortetracycline Combination in amount grams/ton Indications for use Limitations Sponsor

(i) 100 to 200 g/ton ...... Chickens: For control of infec- Feed continuously for 7 to 14 054771 tious synovitis caused by days. For No. 066104: Do not 066104 Mycoplasma synoviae suscep- feed to chickens producing 069254 tible to chlortetracycline. eggs for human consumption. (ii) 100 to 200 g/ton ... Clopidol, 113.5 ...... Broiler and replacement chick- Feed continuously as the sole 016592 ens: As an aid in the preven- ration from the time chicks are tion of coccidiosis caused by placed in floor pens for 7 to Eimeria tenella, E. necatrix, E. 14 days. Do not feed to chick- acervulina, E. maxima, E. ens over 16 weeks of age. Do mivati, and E. brunetti; and for not feed to chickens producing control of infectious synovitis eggs for human consumption. caused by M. synoviae sus- Chlortetracycline as provided ceptible to chlortetracycline. by No. 054771; clopidol as provided by No. 016592 in § 510.600(c) of this chapter.

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Chlortetracycline Combination in amount grams/ton Indications for use Limitations Sponsor

(iii) 100 to 200 g/ton .. Decoquinate, 27.2 ... Chickens: For prevention of coc- Feed continuously for 7 to 14 054771 cidiosis caused by Eimeria days. Bentonite should not be tenella, E. necatrix, E. mivati, used in decoquinate feeds. Do E. acervulina, E. maxima, and not feed to chickens producing E. brunetti; and for control of eggs for human consumption. infectious synovitis caused by Chlortetracycline and M, synoviae susceptible to decoquinate as provided by chlortetracycline. No. 054771 in § 510.600(c) of this chapter. (iv) 100 g/ton ...... Robenidine, 30 ...... Broiler and fryer chickens: As an Feed continuously as sole ra- 054771 aid in the prevention of coc- tion. Do not use this product cidiosis caused by E. mivati, in feeds conta. E. brunetti, E. tenella, E. Chlortetracycline and robenidine acervulina, E. maxima, and E. as provided by No. 054771 in necatrix; as an aid in the con- § 510.600(c) of this chapter. trol of chronic respiratory disease (CRD) caused by Myco- plasma gallisepticum susceptible to chlortetracycline; and as an aid in the control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline. (v) 200 to 400 g/ton ...... Chickens: For the control of Feed continuously for 7 to 14 054771 chronic respiratory disease days. For No. 066104: Do not 066104 (CRD) and air sac infection feed to chickens producing 069254 caused by M. gallisepticum eggs for human consumption. and Escherichia coli susceptible to chlortetracycline. (vi) 200 g/ton ...... Amprolium, 227 and For chickens where immunity to Use in low calcium feed con- 054771 ethopabate, 3.6. coccidiosis is not desired: For taining 0.8% dietary calcium prevention of coccidiosis; and and 1.5% sodium sulfate; feed for treatment of chronic res- continuously as sole ration for piratory disease (CRD) 7 to 14 days; do not feed to caused by M. gallisepticum chickens producing eggs for susceptible to chlortetracycline. human consumption. Chlor- tetracycline as provided by No. 054771; amprolium and ethopabate as provided by No. 016592 in § 510.600(c) of this chapter. (vii) 200 g/ton ...... Decoquinate, 27.2 ... Broilers: As an aid in the pre- Feed continuously as the sole 054771 vention of coccidiosis caused ration for no more than 8 by Eimeria tenella, E. necatrix, weeks. Use in low calcium E. acervulina, E. mivati, E. feed containing 0.8% dietary maxima, and E. brunetti; and calcium. Bentonite should not for the treatment of chronic be used in decoquinate feeds. respiratory disease (air sac in- Do not feed to chickens pro- fection) and the prevention of ducing eggs for human con- synovitis. sumption. Chlortetracycline and decoquinate as provided by No. 054771 in § 510.600(c) of this chapter. (viii) 200 g/ton ...... Robenidine 30 ...... Broiler and fryer chickens: As an Feed continuously as sole ra- 054771 aid in the prevention of coc- tion. Do not use this product cidiosis caused by E. mivati, in feeds containing bentonite. E. brunetti, E. tenella, E. Do not feed to chickens pro- acervulina, E. maxima, and E. ducing eggs for human con- necatrix; as an aid in the consumption. Withdraw 5 days trol of chronic respiratory dis- prior to slaughter. ease (CRD) caused by M. Chlortetracycline and robenidine gallisepticum susceptible to as provided by No. 054771 in chlortetracycline; and as an § 510.600(c) of this chapter. aid in the control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline.

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Chlortetracycline Combination in amount grams/ton Indications for use Limitations Sponsor

(ix) 500 g/ton ...... Chickens: For the reduction of 1. Feed for 5 days. To sponsor 054771 mortality due to E. coli infec- No. 054771 under NADA 048– 069254 tions susceptible to chlortetra- 761 and No. 069254 under cycline. ANADA 200–510: zero withdrawal time. 2. Feed for 5 days; withdraw 24 054771 hours prior to slaughter. Do 066104 not feed to chickens producing 069254 eggs for human consumption. (x) 500 g/ton ...... Monensin, 90 to 110 Chickens: As an aid in the re- Feed for 5 days as the sole ra- 054771 duction of mortality due to E. tion. Do not feed to laying 069254 coli infections susceptible to chickens. Not to be fed con- chlortetracycline; and as an tinuously for more than 5 aid in the prevention of coc- days. Do not feed to chickens cidiosis caused by Eimeria over 16 weeks of age. With- tenella, E. necatrix, E. draw 24 hours before slaugh- acervulina, E. maxima, E. ter. See § 558.355(d) of this brunetti, and E. mivati. chapter. Chlortetracycline as provided by No. 054771; monensin as provided by No. 058198 in § 510.600(c) of this chapter. (xi) 500 g/ton ...... Robenidine, 30 ...... Broiler and fryer chickens: As an Feed continuously as sole ration 054771 aid in the prevention of coc- for up to 5 days. Do not use cidiosis caused by Eimeria this product in feeds con- mivati, E. brunetti, E. tenella, taining bentonite. Do not feed E. acervulina, E. maxima, and to chickens producing eggs for E. necatrix; as an aid in the human consumption. With- reduction of mortality due to draw 5 days prior to slaughter. E. coli susceptible to chlor- Chlortetracycline and robenidine tetracycline. as provided by No. 054771 in § 510.600(c) of this chapter. (xii) 500 g/ton ...... Salinomycin, 40 to Broiler chickens: As an aid in For use in low calcium feeds 016592 60. the prevention of coccidiosis containing 0.8% calcium. Not 054771 caused by Eimeria tenella, E. approved for use with pellet 069254 necatrix, E. acervulina, E. binders. Not to be fed continu- maxima, E. brunetti, and E. ously for more than 5 days. mivati; and as an aid in the re- Do not feed to laying chickens duction of mortality due to E. producing eggs for human coli susceptible to chlortetra- consumption. Withdraw 24 cycline. hours before slaughter. May be fatal if accidentally fed to adult turkeys or horses. Chlor- tetracycline as provided by Nos. 054771 or 069254; salinomycin as provided by Nos. 054771 or 016592 in § 510.600(c) of this chapter.

(2) Turkeys. It is used as follows:

Chlortetracycline Combination in amount grams/ton Indications for use Limitations Sponsor

(i) 200 g/ton ...... Turkeys: For control of infectious Feed continuously for 7 to 14 054771 synovitis caused by M. days. Do not feed to turkeys 066104 synoviae susceptible to chlor- producing eggs for human 069254 tetracycline. consumption. (ii) 400 g/ton...... 1. Turkeys: For control of Feed continuously for 7 to 14 054771 hexamitiasis caused by days. Do not feed to turkeys 066104 Hexamita meleagridis suscep- producing eggs for human 069254 tible to chlortetracycline. consumption...... 2. Turkey poults not over 4 ...... 054771 weeks of age: For reduction of 066104 mortality due to paratyphoid 069254 caused by Salmonella typhimurium susceptible to chlortetracycline.

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Chlortetracycline Combination in amount grams/ton Indications for use Limitations Sponsor

(iii) 25 mg/lb of body ...... Turkeys: For control of compli- Feed continuously for 7 to 14 054771 weight. cating bacterial organisms as- days. Do not feed to turkeys 066104 sociated with bluecomb (trans- producing eggs for human 069254 missible enteritis; coronaviral consumption. enteritis) susceptible to chlortetracycline.

(3) Swine. It is used as follows:

Chlortetracycline Combination in amount grams/ton Indications for use Limitations Sponsor

(i) 50 to 100 g/ton ...... Swine: For reducing the inci- ...... 054771 dence of cervical lymphade- 066104 nitis (jowl abscesses) caused 069254 by Group E Streptococci susceptible to chlortetracycline. (ii) 400 g/ton ...... Breeding swine: For the control Feed continuously for not more 054771 of leptospirosis (reducing the than 14 days. 066104 incidence of abortion and 069254 shedding of leptospirae) caused by Leptospira pomona susceptible to chlortetracycline. (iii) 10 mg/lb of body ...... Swine: For treatment of bacterial Feed approximately 400 g/ton, 054771 weight. enteritis caused by Esch- varying with body weight and 066104 erichia coli and S. feed consumption to provide 069254 choleraesuis and bacterial 10 mg/lb per day. Feed for not pneumonia caused by more than 14 days. Withdraw Pasteurella multocida suscep- 5 d prior to slaughter for spon- tible to chlortetracycline; for sor No. 069254 in the control of porcine prolif- § 510.600(c) of this chapter. erative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline. (iv) 10 mg/lb of body Bacitracin Swine: For treatment of bacterial Feed approximately 400 g/ton, 054771 weight. methylenedisalicyl- enteritis caused by E. coli and varying with body weight and ate, 10 to 30. S. choleraesuis and bacterial feed consumption to provide pneumonia caused by P. 10 mg/lb per day. Feed for not multocida susceptible to chlor- more than 14 days. tetracycline; for the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency. (v) 10 mg/lb of body Bacitracin Swine: For treatment of bacterial Feed chlortetracycline at ap- 054771 weight. methylenedisalicyl- enteritis caused by E. coli and proximately 400 g/ton of feed, 069254 ate, 10 to 30. S. choleraesuis and bacterial varying with body weight and pneumonia caused by P. food consumption, to provide multocida susceptible to chlor- 10 mg/lb of body weight. Feed tetracycline; and for increased for not more than 14 days. rate of weight gain and im- Withdraw 5 d prior to slaugh- proved feed efficiency. ter for sponsor No. 069254. Bacitracin methylenedisalicylate provided by No. 054771; chlortetracycline provided by Nos. 054771 and 069254 in § 510.600(c) of this chapter.

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Chlortetracycline Combination in amount grams/ton Indications for use Limitations Sponsor

(vi) 10 mg/lb of body Tiamulin hydrogen For control of swine dysentery Feed chlortetracycline at ap- 058198 weight. fumarate, 35. associated with Brachyspira proximately 400 g/ton of feed, 069254 (formerly Serpulina or varying with body weight and Treponema) hyodysenteriae food consumption, to provide susceptible to tiamulin and for 10 mg/lb of body weight. Feed treatment of swine bacterial continuously as the sole ration enteritis caused by E. coli and for 14 days. Withdraw medi- Salmonella choleraesuis sen- cated feed 2 days before sitive to chlortetracycline and slaughter. Tiamulin as pro- treatment of bacterial pneu- vided by Nos. 058198 or monia caused by P. multocida 069254 in § 510.600(c) of this sensitive to chlortetracycline. chapter.

(4) Cattle. It is used as follows:

Combination in Chlortetracycline amount grams/ton Indications for use Limitations Sponsor

(i) 0.5 mg/lb of body weight ...... Beef cattle (over 700 lb): For Withdraw 48 hours prior to 054771 daily. control of active infection of slaughter. To sponsor Nos. 066104 anaplasmosis caused by 054771 and 069254: Zero 069254 Anaplasma marginale sus- withdrawal time. ceptible to chlortetracycline. (ii) 25 to 1,100 to provide Lasalocid, 30 to Pasture cattle (slaughter, Feed continuously on a hand- 054771 0.5 mg/lb of body weight 600. stocker, feeder cattle, beef fed basis 0.5 mg chlortetra- daily. replacement heifers) over cycline per lb. body weight 700 pounds: For control of per day and not less than active infection of 60 mg or more than 300 mg anaplasmosis caused by A. lasalocid per head daily in marginale susceptible to at least 1 pound of feed. chlortetracycline; and for in- Daily lasalocid intakes in ex- creased rate of weight gain. cess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/ day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. (iii) 0.5 to 2.0 mg/lb of body ...... Beef cattle and nonlactating In free-choice cattle feeds 054771 weight daily. dairy cattle: As an aid in the such as feed blocks or salt- 069254 control of active infection of mineral mixes manufactured anaplasmosis caused by A. from approved Type A arti- marginale susceptible to cles. See paragraph (d)(4) chlortetracycline. of this section. (iv) 10 mg/lb of body weight ...... 1. Calves, beef and nonlac- Feed approximately 400 g/ton, 054771 daily. tating dairy cattle: For treat- varying with body weight 066104 ment of bacterial enteritis and feed consumption to 069254 caused by Escherichia coli provide 10 mg/lb per day. and bacterial pneumonia Treat for not more than 5 caused by Pasteurella days. In feed including milk multocida organisms sus- replacers withdraw 10 days ceptible to chlortetracycline. prior to slaughter. To sponsor No. 069254: zero withdrawal time. See paragraph (d)(3) of this section. 2. Calves (up to 250 lb): For See paragraph (d)(3) of this 054771 the treatment of bacterial section. 066104 enteritis caused by E. coli 069254 susceptible to chlortetracycline.

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Combination in Chlortetracycline amount grams/ton Indications for use Limitations Sponsor

(v) 10 mg/lb of body weight Laidlomycin, 5 ...... Cattle fed in confinement for Feed continuously at a rate of 054771 daily. slaughter: For treatment of 30 to 75 mg laidlomycin pro- bacterial enteritis caused by pionate potassium per head E. coli and bacterial pneu- per day for not more than 5 monia caused by P. days. A withdrawal period multocida organisms sus- has not been established for ceptible to chlortetracycline; this product in pre-rumi- and for increased rate of nating calves. Do not use in weight and improved feed calves to be processed for efficiency. veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter. (vi) 10 mg/lb of body weight Laidlomycin, 5 to Cattle fed in confinement for Feed continuously at a rate of 054771 daily. 10. slaughter: For treatment of 30 to 75 mg laidlomycin pro- bacterial enteritis caused by pionate potassium per head E. coli and bacterial pneu- per day for not more than 5 monia caused by P. days. A withdrawal period multocida organisms sus- has not been established for ceptible to chlortetracycline; this product in pre-rumi- and for improved feed effi- nating calves. Do not use in ciency. calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter. (vii) 500 to 2,000 to provide Lasalocid, 10 to 30 Cattle fed in confinement for Feed continuously in complete 054771 10 mg/lb of body weight slaughter: For treatment of feed for not more than 5 daily. bacterial enteritis caused by days to provide 10 mg E. coli and bacterial pneu- chlortetracycline per lb. monia caused by P. body weight per day and not multocida organisms sus- less than 100 mg or more ceptible to chlortetracycline; than 360 mg lasalocid per and for improved feed effi- head per day. Do not allow ciency. horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. (viii) 500 to 1,200 to pro- Lasalocid, 25 to 30 Cattle fed in confinement for Feed continuously in complete 054771 vide 10 mg/lb of body slaughter: For treatment of feed for not more than 5 weight daily. bacterial enteritis caused by days to provide 10 mg E. coli and bacterial pneu- chlortetracycline per lb. monia caused by P. body weight per day and not multocida organisms sus- less than 250 mg or more ceptible to chlortetracycline; than 360 mg lasalocid per and for increased rate of head per day. Do not allow weight gain and improved horses or other equines ac- feed efficiency. cess to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter.

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Combination in Chlortetracycline amount grams/ton Indications for use Limitations Sponsor

(ix) 500 to 4,000 to provide Lasalocid, 30 to Pasture cattle (slaughter, Feed continuously on a hand- 054771 10 mg/lb of body weight 600. stocker, feeder cattle, dairy fed basis for not more than daily. and beef replacement heif- 5 days to provide 10 mg ers): For treatment of bac- chlortetracycline per lb. terial enteritis caused by E. body weight per day and not coli and bacterial pneu- less than 60 mg or more monia caused by P. than 300 mg lasalocid per multocida organisms sus- head per day in at least 1 ceptible to chlortetracycline; pound of feed. Daily and for increased rate of lasalocid intakes in excess weight gain. of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/ day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. (x) 500 to 4,000 g/ton ...... Calves, beef and nonlactating Feed continuously for not 054771 dairy cattle: For the treat- more than 5 days to provide 069254 ment of bacterial enteritis 10 mg/lb body weight per caused by E. coli and bac- day. To sponsor No. 054771 terial pneumonia caused by under NADA 046–699: 24- P. multocida susceptible to hour withdrawal period. To chlortetracycline. sponsor No. 054771 under NADA 048–761 and No. 069254 under ANADA 200– 510: Zero withdrawal period. (xi) 500 to 4,000 ...... Decoquinate, 12.9 Calves, beef and non-lactating Feed at a rate of 1g chlortetra- 054771 to 90.8. dairy cattle: For the treat- cycline per 100 lb body 069254 ment of bacterial enteritis weight/day and 22.7 mg caused by E. coli and bac- decoquinate per 100 lb of terial pneumonia caused by body weight/day for not P. multocida susceptible to more than 5 days. When it chlortetracycline; and for the is fully consumed, resume prevention of coccidiosis feeding 22.7 mg caused by Eimeria bovis decoquinate per 100 lb of and E. zuernii. body weight/day for a total of 28 days to prevent coccidiosis. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in § 510.600(c) of this chapter. (xii) 4,000 to 20,000 g/ton ...... Calves, beef and nonlactating As a top dress, varying with 054771 dairy cattle: For the treat- body weight and feed con- 069254 ment of bacterial enteritis sumption, to provide 10 mg/ caused by E. coli and bac- lb per day. Treat for not terial pneumonia caused by more than 5 days. See P. multocida organisms sus- paragraph (d)(3) of this sec- ceptible to chlortetracycline. tion.

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Combination in Chlortetracycline amount grams/ton Indications for use Limitations Sponsor

(xiii) 4,000 to 20,000 g/ton Decoquinate, 90.8 Calves, beef and non-lactating Administer as a top dress sup- 054771 to 535.7. dairy cattle: For the treat- plement or mix into the daily ment of bacterial enteritis ration to provide 22.7 mg caused by E. coli and bac- decoquinate per 100 lb of terial pneumonia caused by body weight per day and 1 P. multocida susceptible to g chlortetracycline per 100 chlortetracycline; and for the lb body weight/day for not prevention of coccidiosis more than 5 days. When it caused by E. bovis and E. is fully consumed, resume zuernii. feeding 22.7 mg decoquinate per 100 lb of body weight/day for a total of 28 days to prevent coccidiosis. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in § 510.600(c) of this chapter. (xiv) 70 mg/head/day ...... Growing cattle (over 400 lb): See paragraph (d)(3) of this 054771 For reduction of incidence of section. 066104 liver abscesses. 069254 (xv) 350 mg/head/day ...... 1. Beef cattle: For control of Withdraw 48 h prior to slaugh- 054771 bacterial pneumonia associ- ter. To sponsor No. 054771 066104 ated with shipping fever under NADA 046–699: 48- 069254 complex caused by hour withdrawal time. To Pasteurella spp. susceptible sponsor No. 054771 under to chlortetracycline. NADA 048–761 and No. 069254 under ANADA 200– 510: zero withdrawal period. 2. Beef cattle (under 700 lb): Withdraw 48 h prior to slaugh- 054771 For control of active infec- ter. To sponsor No. 054771 066104 tion of anaplasmosis caused under NADA 046–699: 48- 069254 by A. marginale susceptible hour withdrawal time. To to chlortetracycline. sponsor No. 054771 under NADA 048–761 and No. 069254 under ANADA 200– 510: zero withdrawal time. (xvi) 350 mg/head/day ...... Laidlomycin, 5 ...... Cattle fed in confinement for Feed continuously at a rate of 054771 slaughter: For control of 30 to 75 mg laidlomycin pro- bacterial pneumonia associ- pionate potassium per head ated with shipping fever per day. A withdrawal period complex caused by has not been established for Pasteurella spp. susceptible this product in pre-rumi- to chlortetracycline; and for nating calves. Do not use in increased rate of weight and calves to be processed for improved feed efficiency. veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter. (xvii) 350 mg/head/day ...... Laidlomycin, 5 to Cattle fed in confinement for Feed continuously at a rate of 054771 10. slaughter: For control of 30 to 75 mg laidlomycin pro- bacterial pneumonia associ- pionate potassium per head ated with shipping fever per day. A withdrawal period complex caused by has not been established for Pasteurella spp. susceptible this product in pre-rumi- to chlortetracycline; and for nating calves. Do not use in improved feed efficiency. calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter.

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Combination in Chlortetracycline amount grams/ton Indications for use Limitations Sponsor

(xviii) 25 to 42.2 g/ton to Lasalocid, 25 to 30 Cattle under 700 pounds fed Feed continuously in complete 054771 provide 350 mg/head/day. in confinement for slaughter: feed at a rate of 350 mg For control of active infec- chlortetracycline and not tion of anaplasmosis caused less than 250 mg nor more by A. marginale susceptible than 360 mg lasalocid per to chlortetracycline; and for head daily. Do not allow increased rate of weight horses or other equines ac- gain and improved feed effi- cess to feeds containing ciency. lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. (xix) 25 to 42.2 g/ton to Lasalocid, 25 to 30 Cattle fed in confinement for Feed continuously in complete 054771 provide 350 mg/head/day. slaughter: For control of feed at a rate of 350 mg bacterial pneumonia associ- chlortetracycline and not ated with shipping fever less than 250 mg nor more complex caused by P. than 360 mg lasalocid per multocida organisms sus- head daily. Do not allow ceptible to chlortetracycline; horses or other equines ac- and for increased rate of cess to feeds containing weight gain and improved lasalocid. No withdrawal pe- feed efficiency. riod is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. (xx) 25 to 100 g/ton to pro- Lasalocid, 10 to 30 Cattle under 700 pounds fed Feed continuously in complete 054771 vide 350 mg/head/day. in confinement for slaughter: feed at a rate of 350 mg For control of active infec- chlortetracycline and not tion of anaplasmosis caused less than 100 mg nor more by A. marginale susceptible than 360 mg lasalocid per to chlortetracycline; and for head daily. Do not allow improved feed efficiency. horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter.

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Combination in Chlortetracycline amount grams/ton Indications for use Limitations Sponsor

(xxi) 25 to 100 g/ton to pro- Lasalocid, 10 to 30 Cattle fed in confinement for Feed continuously in complete 054771 vide 350 mg/head/day. slaughter: For control of feed at a rate of 350 mg bacterial pneumonia associ- chlortetracycline and not ated with shipping fever less than 100 mg nor more complex caused by P. than 360 mg lasalocid per multocida organisms sus- head daily. Do not allow ceptible to chlortetracycline; horses or other equines ac- and for improved feed effi- cess to feeds containing ciency. lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. (xxii) 25 to 700 to provide Lasalocid, 30 to Pasture cattle (slaughter, Feed continuously on a hand- 054771 350 mg/head/day. 600. stocker, feeder cattle, dairy fed basis at a rate of 350 and beef replacement heif- mg chlortetracycline and not ers): For control of bacterial less than 60 mg nor more pneumonia associated with than 300 mg lasalocid per shipping fever complex head per day in at least 1 caused by P. multocida or- pound of feed. Daily ganisms susceptible to lasalocid intakes in excess chlortetracycline; and for in- of 200 mg/head/day in pas- creased rate of weight gain. ture cattle have not been shown to be more effective than 200 mg lasalocid/head/ day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. (xxiii) 25 to 700 to provide Lasalocid, 30 to Pasture cattle (slaughter, Feed continuously on a hand- 054771 350 mg/head/day. 600. stocker, feeder cattle, beef fed basis at a rate of 350 replacement heifers) under mg chlortetracycline and not 700 pounds: For control of less than 60 mg nor more active infection of than 300 mg lasalocid per anaplasmosis caused by A. head per day in at least 1 marginale susceptible to pound of feed. Daily chlortetracycline; and for in- lasalocid intakes in excess creased rate of weight gain. of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/ day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter.

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Combination in Chlortetracycline amount grams/ton Indications for use Limitations Sponsor

(xxiv) 25 to 2,800 to pro- Lasalocid, 30 to Beef cattle weighing under Hand feed continuously at a 054771 vide 350 mg/head/day. 181.8. 700 pounds: For control of rate of 350 mg chlortetra- active infection of cycline and 1 mg lasalocid anaplasmosis caused by per 2.2 lb. body weight daily Anaplasma marginale sus- to cattle with a maximum of ceptible to chlortetracycline; 360 mg of lasalocid per and for the control of coc- head per day. Do not allow cidiosis caused by Eimeria horses or other equines ac- bovis and E. zuernii. cess to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Chlortetracycline and lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. (xxv) 25 to 2,800 to provide Lasalocid, 30 to Beef cattle weighing up to 800 Hand feed continuously at a 054771 350 mg/head/day. 181.8. pounds: For control of bac- rate of 350 mg chlortetra- terial pneumonia associated cycline and 1 mg lasalocid with shipping fever complex per 2.2 lb. body weight daily caused by Pasteurella spp. to cattle with a maximum of susceptible to chlortetra- 360 mg of lasalocid per cycline; and for the control head per day. Do not allow of coccidiosis caused by E. horses or other equines ac- bovis and E. zuernii. cess to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. (xxvi) 500 to 4,000 to pro- Lasalocid, 30 to Cattle weighing up to 800 Hand feed continuously for not 054771 vide 10 mg/head/day. 181.8. pounds: For the treatment of more than 5 days at a rate bacterial enteritis caused by of 10 mg chlortetracycline E. coli and bacterial pneu- and 1 mg lasalocid per 2.2 monia caused by P. lb. body weight daily to cat- multocida susceptible to tle with a maximum of 360 chlortetracycline; and for the mg of lasalocid per head control of coccidiosis per day. Do not allow caused by Eimeria bovis horses or other equines ac- and E. zuernii. cess to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter.

(5) Minor species. It is used as follows:

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Chlortetracycline amount Indications for use Limitations Sponsor

(i) 80 mg/head/day...... Breeding sheep; reducing the inci- ...... 054771 dence of (vibrionic) abortion caused 066104 by Campylobacter fetus infection 069254 susceptible to chlortetracycline. (ii) 200 to 400 g/ton ...... Ducks: For the control and treatment of Feed in complete ration to provide from 054771 fowl cholera caused by Pasteurella 8 to 28 mg/lb of body weight per 069254 multocida susceptible to chlortetra- day, depending upon age and sever- cycline. ity of disease, for not more than 21 days. Do not feed to ducks producing eggs for human consumption. (iii) 10 mg/g of finished feed Psittacine birds (cockatoos, macaws, Feed continuously for 45 days. Each 054771 daily. and parrots) suspected or known to bird should consume daily an 069254 be infected with psittacosis caused amount of medicated feed equal to by Chlamydia psittaci sensitive to one fifth of its body weight. See chlortetracycline. paragraph (d)(5) of this section.

(6) It is used as a free-choice, loose § 558.140 Chlortetracycline and mineral Type C feed as follows: sulfamethazine. (i) Specifications. (a) Specifications. Type A medicated International feed articles containing: Ingredient Percent No. (1) 35 grams (g) per pound (/lb) each, chlortetracycline and sulfamethazine. Dicalcium Phos- phate ...... 46.20 6–26–335 (2) 40 g/lb each, chlortetracycline and Sodium Chloride sulfamethazine. (Salt) ...... 15.00 6–04–152 (b) Sponsors. See sponsors numbers in Magnesium Oxide 10.67 6–02–756 Cottonseed Meal ... 10.00 5–01–625 § 510.600(c) of this chapter as follow: Trace Mineral/Vita- (1) Nos. 054771 and 069254 for use of min Premix 1 ...... 3.80 product described in paragraph (a)(1) as Calcium Carbonate 3.50 6–01–069 in paragraph (e)(1) of this section. Dried Cane Molas- ses ...... 3.00 4–04–695 (2) Nos. 054771 and 069254 for use of Potassium Chloride 2.00 6–03–755 product described in paragraph (a)(2) as Mineral Oil ...... 2.00 8–03–123 in paragraph (e)(2) of this section. Iron Oxide ...... 0.50 6–02–431 Chlortetracycline (c) Related tolerances. See §§ 556.150 Type A medi- and 556.670 of this chapter. cated article (90 (d) Special considerations. (1) Federal gram/lb) ...... 3.33 law restricts medicated feed containing 1 Content of vitamin and trace mineral premixes may be this veterinary feed directive (VFD) varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require drug to use by or on the order of a li- FDA approval prior to marketing. Selenium must comply with censed veterinarian. See § 558.6 for addi- 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. tional requirements. 651.100 (CPG 7125.18). (2) The expiration date of VFDs for (ii) Amount. 6,000 grams per ton. chlortetracycline and sulfamethazine (iii) Indications for use. Beef and medicated feeds must not exceed 6 nonlactating dairy cattle: As an aid in months from the date of issuance. the control of active infection of VFDs for chlortetracycline and anaplasmosis caused by Anaplasma sulfamethazine shall not be refilled. marginale susceptible to chlortetra- (e) Conditions of use—(1) Cattle. It is cycline. used in feed for beef cattle as follows: (iv) Limitations. Feed continuously on (i) Amount. 350 milligrams per head a free-choice basis at a rate of 0.5 to 2.0 per day each, chlortetracycline and mg chlortetracycline per pound of body sulfamethazine. weight per day. (ii) Indications for use. Aid in the (v) Sponsors. See Nos. 054771 and maintenance of weight gains in the 069254 in § 510.600(c) of this chapter. presence of respiratory disease such as [81 FR 94995, Dec. 27, 2016, as amended at 82 shipping fever. FR 21691, May 10, 2017; 82 FR 43485, Sept. 18, (iii) Limitations. Feed for 28 days; 2017; 83 FR 13636, Mar. 30, 2018] withdraw 7 days prior to slaughter. A

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withdrawal period has not been estab- (iii) Limitations. Feed as the sole ra- lished for this product in pre-rumi- tion. Withdraw 15 days prior to slaugh- nating calves. Do not use in calves to ter. be processed for veal. [79 FR 37622, July 2, 2014, as amended at 80 (2) Swine. It is used in swine feed as FR 13231, Mar. 13, 2015; 81 FR 63054, Sept. 14, follows: 2016; 81 FR 95004, Dec. 27, 2016; 82 FR 21691, (i) Amount. 100 g/ton each, chlortetra- May 10, 2017] cycline and sulfamethazine. (ii) Indications for use. For reduction § 558.175 Clopidol. of the incidence of cervical abscesses; (a) Specifications. Type A medicated treatment of bacterial swine enteritis article containing 25 percent clopidol. (salmonellosis or necrotic enteritis (b) Sponsor. See No. 016592 in caused by Salmonella choleraesuis and § 510.600(c) of this chapter. vibrionic dysentery); prevention of (c) Related tolerances. See § 556.160 of these diseases during times of stress; this chapter. and maintenance of weight gains in the (d) Conditions of use. It is used as fol- presence of atrophic rhinitis. lows:

Clopidol in grams Combination in per ton grams per ton Indications for use Limitations Sponsor

(1) 113.5...... Broiler chickens and re-placement Do not feed to chickens over 016592 chickens intended for use as caged 16 weeks of age. layers: As an aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati. (2) 113.5 ...... Bacitracin Broiler chickens: As in paragraph Feed continuously as the sole 016592 methylenedisalicyl- (d)(1) of this section; for increased ration from the time chicks ate 4 to 50. rate of weight gain. are placed in floor pens until slaughter. Do not feed to chickens over 16 weeks of age; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. (3) 113.5 ...... Bacitracin zinc 5 to Broiler chickens: As in paragraph Feed continuously as sole ra- 054771 25. (d)(1) of this section; for increased tion; bacitracin zinc as pro- 016592 rate of weight gain and improved vided by No. 054771 in feed efficiency. § 510.600(c) of this chapter. (4) 113.5 ...... Bambermycins 1 to 2 Broiler chickens: As an aid in preven- Feed continuously as the sole 016592 tion of coccidiosis caused by ration. Do not feed to chick- Eimeria tenella, E. necatrix, E. ens over 16 weeks of age acervulina, E. maxima, E. brunetti, and E. mivati; and for increased rate of weight gain and improved feed efficiency (5)–(6) [Re- served]. (7) 227 ...... Broiler and replacement chickens in- Feed continuously as the sole 016592 tended for use as caged layers: As ration; feed up to 16 weeks in paragraph (d)(1) of this section. of age if intended for use as caged layers; withdraw 5 days before slaughter if given at the level of 0.025 percent in feed or reduce level to 0.0125 percent 5 days before slaughter. (8) 227 ...... Bambermycins 1 to 2 Broiler chickens: As an aid in preven- Feed continuously as sole ra- 016592 tion of coccidiosis caused by tion until 5 days before Eimeria tenella, E. necatrix, E. slaughter. Withdraw 5 days acervulina, E. maxima, E. brunetti, before slaughter or feed and E. mivati; and for increased 113.5 g/ton clopidol and 1 to rate of weight gain and improved 2 g/ton bambermycins during feed efficiency those 5 days before slaughter. Do not feed to chickens over 16 weeks of age

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Clopidol in grams Combination in per ton grams per ton Indications for use Limitations Sponsor

(9) 113.5 or 227 ...... Turkeys: As an aid in the prevention For turkeys grown for meat pur- 016592 of leucocytozoonosis caused by poses only; feed continuously Leucocytozoon smithi. as the sole ration at 0.0125 or 0.025 percent clopidol depending on management practices, degree of exposure, and amount of feed eaten; withdraw 5 days before slaughter.

(e) Clopidol may also be used in com- spp., Ostertagia spp., Cooperia spp., bination with: Nematodirus spp., Trichostrongylus spp.). (1)–(2) [Reserved] (iii) Limitations. Feed in the normal (3) Chlortetracycline as in § 558.128. grain ration to which the animals are (4) Lincomycin as in § 558.325. accustomed, but not in rations containing more than 0.1 percent [68 FR 17882, Apr. 14, 2003, as amended at 72 coumaphos. Do not feed to animals less FR 60551, Oct. 25, 2007; 74 FR 61028, Nov. 23, than 3 months old. Do not feed to sick 2009; 79 FR 10965, 10982, Feb. 27, 2014; 79 FR animals or animals under stress, such 13545, Mar. 11, 2014; 81 FR 17609, Mar. 30, 2016; 81 FR 95004, Dec. 27, 2016] as those just shipped, dehorned, cas- trated, or weaned within the last 3 § 558.185 Coumaphos. weeks. Do not feed in conjunction with oral drenches or with feeds containing (a) Specifications. Type A medicated phenothiazine. articles containing 1.12, 2.0, 11.2, or 50 (2) Laying chickens—(i) Amount. percent coumaphos. Coumaphos 27.2 grams per ton (0.003 (b) Approvals. See sponsors in percent). § 510.600(c) of this chapter for use as in (ii) Indications for use. For control of paragraph (e) of this section. capillary worm (Capillaria obsignata) (1) No. 000859 for use of Type A medi- and as an aid in control of common cated articles containing 1.12, 2.0, 11.2, round worm (Ascaridia galli) and cecal or 50 percent coumaphos as in para- worm (Heterakis gallinae). graphs (e)(2) and (e)(3) of this section. (iii) Limitations. In Type C feed; ad- (2) No. 051311 for use of Type A medi- minister continuously as the total feed cated articles containing 1.12 percent ration for 14 days; when reinfection oc- coumaphos as in paragraph (e)(1) of curs, treatment may be repeated but this section. not sooner than 3 weeks after the end (c) Related tolerances. See 40 CFR of the previous treatment; do not feed 180.189. to chickens within 10 days of vaccina- (d) Special considerations. Labeling tion or other conditions of stress; shall bear the following caution state- treatment of colored breeds of commer- ment: ‘‘The active ingredient cial layers should be avoided while in coumaphos is a cholinesterase inhib- production since these breeds appear to itor. Do not use this product on ani- be more sensitive to coumaphos than mals simultaneously or within a few white breeds; as sole medication; medi- days before or after treatment with or cations in general should be avoided exposure to cholinesterase-inhibiting while birds are approaching peak pro- drugs, pesticides, or chemicals.’’ Also, duction; such interruption of normal see § 500.25 of this chapter. feeding practices may upset the flock (e) Conditions of use—(1) Beef and and lower egg production; diagnosis by dairy cattle—(i) Amount. 0.0002 lb. (0.091 competent personnel is essential; flock gram) per 100 lb. body weight per day condition and production records for 6 consecutive days. Should condi- should be carefully evaluated prior to tions warrant, repeat treatment at 30- treatment. day intervals. (3) Replacement pullets—(i) Amount. (ii) Indications for use. Control of gas- Coumaphos 36.3 grams per ton (0.004 trointestinal roundworms (Haemonchus percent).

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(ii) Indications for use. For control of § 558.195 Decoquinate. capillary worm (Capillaria obsignata) and as an aid in control of common (a) Specifications. Type A medicated roundworm (Ascaridia galli) and cecal article containing 6 percent worm (Heterakis gallinae). decoquinate. (iii) Limitations. In Type C feed; ad- (b) Approvals. See No. 054771 in minister before the onset of produc- § 510.600(c) of this chapter. tion; diagnosis by competent personnel (c) Related tolerances. See § 556.170 of is essential; administer continuously this chapter. as total feed ration for from 10 to 14 (d) Special considerations. (1) Ben- days; do not feed to chickens under 8 tonite should not be used in weeks of age nor within 10 days of vac- decoquinate feeds. cination or other conditions of stress; (2) Type A medicated articles may be if birds are maintained on contami- used to manufacture dry or liquid Type nated litter or exposed to infected B cattle (including veal calf), sheep, birds, a second 10 to 14 day treatment and goat feeds as in paragraphs (e)(2) is recommended but not sooner than 3 and (e)(3) of this section. weeks after the end of the previous treatment; as sole medication; if rein- (3) Type C cattle feeds may be manu- fection occurs after production begins, factured from decoquinate liquid Type repeat treatment as recommended for B feeds having a pH between 5.0 to 6.5 laying flocks. and containing a suspending agent to maintain a viscosity of not less than [40 FR 13959, Mar. 27, 1975, as amended at 42 500 centipoises. FR 1463, Jan. 7, 1977; 51 FR 7397, Mar. 3, 1986; 52 FR 2684, Jan. 26, 1987; 61 FR 34729, July 3, (e) Conditions of use. It is used as fol- 1996; 69 FR 70056, Dec. 2, 2004; 70 FR 32489, lows: June 3, 2005; 75 FR 24394, May 5, 2010] (1) Chickens.

Decoquinate in Combination in grams/ton grams/ton Indications for use Limitations Sponsor

(i) 27.2...... Broiler chickens: For prevention of Do not feed to laying hens pro- 054771 coccidiosis caused by Eimeria ducing eggs for human con- tenella, E. necatrix, E. mivati, E. sumption.. acervulina, E. maxima, and E. brunetti.. (ii) 27.2 ...... Bacitracin Broiler chickens: As in paragraph Feed continuously as sole ra- 054771 methylenedisalicyl- (e)(1)(i) of this section; and for in- tion; do not feed to laying ate 4 to 50. creased rate of weight gain and im- chickens. Bacitracin proved feed efficiency.. methylenedisalicylate as provided by No. 054771in § 510.600(c) of this chapter.. (iii) 27.2 ...... Bacitracin zinc 10 to Broiler chickens: As in paragraph Feed continuously as sole ra- 054771 50. (e)(1)(ii) of this section.. tion; do not feed to laying chickens. Bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter.. (iv)–(vi) [Re- served].

(2) Cattle.

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Decoquinate in Combination in grams/ton grams/ton Indications for use Limitations Sponsor

(i) 12.9 to 90.8 ...... Cattle (including ruminating and non- Feed Type C feed or milk re- 054771 ruminating calves and veal calves): placer to provide 22.7 milli- For prevention of coccidiosis grams (mg) per 100 pounds caused by Eimeria bovis and E. (lb) of body weight (0.5 mg/ zuernii. kg) per day. Feed at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to cows producing milk for human consumption. See paragraph (d)(3) of this section.. (ii) [Reserved]. (iii) 12.9 to 90.8 .. Monensin 5 to 30 ..... Cattle fed in confinement for slaugh- Feed only to cattle fed in con- 054771 ter: As in paragraph (e)(2)(i) of this finement for slaughter. Feed section; and for improved feed effi- continuously as the sole ra- ciency.. tion to provide 22.7 mg of decoquinate per 100 lb body weight per day and 50 to 360 mg of monensin per head per day. Feed at least 28 days during period of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to animals producing milk for food. Do not feed to lactating dairy cattle. Also see paragraph (d)(1) of this section and § 558.355(d)(8). Monensin as provided by No. 058198 in § 510.600(c) of this chapter.. (iv) [Reserved]. (v) 13.6 to 27.2 ... Monensin 5 to 30 Cattle fed in confinement for slaugh- Feed only to cattle fed in con- 016592, plus tylosin 8 to 10. ter: As in paragraph (e)(2)(i) of this finement for slaughter. Feed 054771 section; for improved feed effi- continuously as the sole ra- ciency; and for reduction of inci- tion to provide 22.7 mg of dence of liver abscesses caused by decoquinate per 100 lb body Fusobacterium necrophorum and weight per day, 50 to 360 mg Actinomyces (Corynebacterium) of monensin per head per pyogenes.. day, and 60 to 90 mg of tylosin per head per day. Feed at least 28 days during period of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to animals producing milk for food. Also see paragraph (d)(1) of this section and § 558.355(d)(8). Monensin as provided by No. 058198, and tylosin as provided by Nos. 058198 and 016592 in § 510.600(c) of this chapter. (vi) 90.9 to 535.7 ...... Cattle (including ruminating and non- Feed Type C medicated feed 054771 ruminating calves and veal calves): supplements as a top dress As in paragraph (e)(2)(i) of this sec- or mix into the daily ration to tion.. provide 22.7 mg per 100 lb of body weight (0.5 mg/kg) per day. Feed at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to cows producing milk for food. See paragraph (d)(3) of this section.. (vii) [Reserved].

(3) Minor species.

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Decoquinate in Combination in grams/ton grams/ton Indications for use Limitations Sponsor

(i) 12.9 to 90.8 ...... 1. Young sheep: For the prevention of Feed Type C feed or milk re- 054771 coccidiosis caused by Eimeria placer at a rate to provide ovinoidalis, E. crandallis, E. parva, 22.7 mg per 100 lb of body and E. bakuensis.. weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to sheep producing milk for human consumption...... 2. Young goats: For the prevention of Feed Type C feed or milk re- coccidiosis caused by E. placer at a rate to provide christenseni and E. 22.7 mg per 100 lb of body ninakohlyakimovae.. weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to goats producing milk for human consumption.. (ii) 90.9 to 535.7 ...... 1. Young sheep: As in item 1 of para- Feed Type C medicated feed 054771 graph (e)(3)(i) of this section.. supplements as a top dress or mix into the daily ration to provide 22.7 mg per 100 lbs of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to sheep producing milk for human consumption...... 2. Young goats: As in item 2 of para- Feed Type C medicated feed graph (e)(3)(i) of this section.. supplements as a top dress or mix into the daily ration to provide 22.7 mg per 100 lbs of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to goats producing milk for human consumption..

(4) Decoquinate may also be used in § 558.198 Diclazuril. combination with: (i)–(ii) [Reserved] (a) Specifications. Type A medicated (iii) Chlortetracycline as in § 558.128. article containing 0.2 percent (iv) Lincomycin as in § 558.325. diclazuril. (b) Approvals. See No. 016592 in [67 FR 72370, Dec. 5, 2002; 68 FR 15372, Mar. 31, § 510.600(c) of this chapter. 2003; 69 FR 26499, May 13, 2004; 69 FR 52816, Aug. 30, 2004; 69 FR 62407, Oct. 26, 2004; 69 FR (c) Related tolerances. See § 556.185 of 67264, Nov. 17, 2004; 70 FR 2567, Jan. 14, 2005; this chapter. 78 FR 25183, Apr. 30, 2013; 79 FR 10982, Feb. 27, (d) Conditions of use—(1) Chickens. For 2014; 79 FR 13545, Mar. 11, 2014; 79 FR 17860, chickens it is used as follows: Mar. 31, 2014; 80 FR 13231, Mar. 13, 2015; 81 FR 17609, Mar. 30, 2016; 81 FR 22525, Apr. 18, 2016; 81 FR 67152, Sept. 30, 2016; 81 FR 95004, Dec. 27, 2016]

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Diclazuril grams/ Combination grams/ ton ton Indications for use Limitations Sponsor

(i) 0.91 (1 part ...... Broiler chickens: For the prevention of Feed continuously. Not for use 016592 per million coccidiosis caused by Eimeria in hens producing eggs for (ppm)). tenella, E. necatrix, E. acervulina, human food.. E. brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima.. (ii) 0.91 (1 ppm) .. Bacitracin Broiler chickens: As in item (i) of this As in item (i) of this table. Baci- 016592 methylenedisalicyl- table; for increased rate of weight tracin methylenedisalicylate ate 4 to 50. gain and improved feed efficiency.. provided by 054771.. (iii) 0.91 (1 ppm) Bambermycins 1 to 2 Broiler chickens: As in item (i) of this As in item (i) of this table. 016592 table); for increased rate of weight Bambermycins provided by gain and improved feed efficiency.. 057926.. (iv)–(v) [Re- served].

(2) Turkeys. For turkeys it is used as follows:

Diclazuril grams/ Combination grams/ ton ton Indications for use Limitations Sponsor

(i) 0.91 (1 ppm) ...... Growing turkeys: For the prevention Feed continuously as the sole 016592 of coccidiosis caused by E. ration. Do not feed to breed- adenoeides, E. gallopavonis and E. ing turkeys. Not for use in meleagrimitis.. hens producing eggs for human consumption.. (ii) 0.91 (1 ppm). Bacitracin Growing turkeys: As in paragraph As in paragraph (d)(2)(i) of this 016592 methylenedisalicyl- (d)(2)(i) of this section; for in- section. Bacitracin ate 4 to 50.. creased rate of weight gain and im- methylenedisalicylate pro- proved feed efficiency.. vided by No. 054771 in § 510.600(c) of this chapter.. (iii) 0.91 (1 ppm). Bambermycins 1 to 2 Growing turkeys: As in paragraph As in paragraph (d)(2)(i) of this 016592 (d)(2)(i) of this section; for improved section. Bambermycins pro- feed efficiency.. vided by No. 057926 in § 510.600(c) of this chapter.. (iv) 0.91 (1 ppm). Bambermycins 2 ...... Growing turkeys: As in paragraph As in paragraph (d)(2)(i) of this 016592 (d)(2)(i) of this section; for in- section. Bambermycins pro- creased rate of weight gain and im- vided by No. 057926 in proved feed efficiency.. § 510.600(c) of this chapter..

(3) Diclazuril may also be used in form only after the crumble feed has combination with virginiamycin as in been manufactured. Do not mix in § 558.635. feeds to be pelleted nor with pelleted [64 FR 35923, July 2, 1999, as amended at 65 feed. Do not soak the feed or admin- FR 50134, Aug. 17, 2000; 66 FR 47962, 47963, ister as wet mash. Feed must be dry Sept. 17, 2001; 66 FR 62917, Dec. 4, 2001; 67 FR when administered. Do not use in ani- 34830, May 16, 2002; 67 FR 47257, July 18, 2002; mals other than swine. Do not allow 67 FR 48549, July 25, 2002; 69 FR 9947, Mar. 3, fowl access to feed containing this 2004; 72 FR 60552, Oct. 25, 2007; 79 FR 10982, preparation or to feces from treated Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014; 81 FR 17609, Mar. 30, 2016; 81 FR 95004, Dec. 27, 2016] animals. (2) Dichlorvos is a cholinesterase in- § 558.205 Dichlorvos. hibitor. Do not use this product in ani- (a) Approvals. Type A medicated arti- mals simultaneously or within a few cles: 3.1 and 9.6 percent to 054628 in days before or after treatment with or § 510.600(c) of this chapter. exposure to cholinesterase-inhibiting (b) Special considerations. (1) drugs, pesticides, or chemicals. If Dichlorvos is to be included in meal or human or animal poisoning should mash or mixed with feed in crumble occur, immediately consult a physician

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or a veterinarian. Atropine is anti- (Trichuris suis), nodular worm dotal. (Oesophagostomum supp. ) large (3) Labeling for Type A articles and roundworm (Ascaris suum), and the Type B feeds must include a statement thick stomach worm (Ascarops that containers or materials used in strongylina) occurring in the gastro- packaging such Type A articles and intestinal tract of the sow or gilt. Type B feeds are not to be reused and (ii) Limitations. For pregnant swine; all such packaging materials must be mix into a gestation feed to provide destroyed after the product has been 1,000 milligrams per head daily during used. last 30 days of gestation. (c) Related tolerances. See § 556.180 of this chapter. [40 FR 13959, Mar. 27, 1975, as amended at 40 FR 50258, Oct. 29, 1975; 48 FR 46515, Oct. 13, (d) Conditions of use. It is used in feed 1983; 51 FR 7397, Mar. 3, 1986; 51 FR 28547, for swine as follows: Aug. 8, 1986; 52 FR 2684, Jan. 26, 1987; 62 FR (1) Amount per ton. Dichlorvos, 348 35077, June 30, 1997; 78 FR 21060, Apr. 9, 2013] grams (0.0384 percent). (i) Indications for use. For the re- § 558.235 Efrotomycin. moval and control of mature, imma- (a) Approvals. Type A medicated arti- ture, and/or fourth-stage larvae of the cle: 14.5 grams per pound to 050604 in whipworm (Trichuris suis), nodular § 510.600(c) of this chapter. worm (Oesophagostomum sp. ), large (b) Conditions of use—(1) Swine—(i) roundworm (Ascaris suum) and the Amount. 3.6 grams per ton. thick stomach worm (Ascarops (A) Indications for use. For improved strongylina) of the gastrointestinal feed efficiency. tract. (B) Limitations. Feed continuously as (ii) Limitations. For swine up to 70 sole ration. Not to be used in swine pounds body weight, feed as sole ration weighing more than 250 pounds. for 2 consecutive days. For swine from (ii) Amount. 3.6 to 14.5 grams per ton. 70 pounds to market weight, feed as (A) Indications for use. For increased sole ration at the rate of 8.4 pounds of rate of weight gain. feed per head until the medicated feed (B) Limitations. Feed continuously as has been consumed. For boars, open or sole ration. Not to be used in swine bred gilts, and sows, feed as sole ration weighing more than 250 pounds. at the rate of 4.2 pounds per head per (2) [Reserved] day for 2 consecutive days. (2) Amount per ton. Dichlorvos, 479 [57 FR 38442, Aug. 25, 1992, as amended at 62 grams (0.0528 percent). FR 63271, Nov. 28, 1997] (i) Indications for use. For the removal and control of mature, imma- § 558.248 Erythromycin. ture, and/or fourth-stage larvae of the (a) Specifications. Type A medicated whipworm (Trichuris suis), nodular articles containing 92.5 grams per worm (Oesophagostomum sp. ), large pound erythromycin (as the roundworm (Ascaris suum), and the thiocyanate salt). thick stomach worm (Ascarops (b) Sponsor. See No. 061623 in strongylina) of the gastrointestinal § 510.600(c) of this chapter. tract. (c) Related tolerances. See § 556.230 of (ii) Limitations. For boars, open or this chapter. bred gilts, and sows, feed as sole ration (d) Special considerations. (1) Federal at the rate of 6 pounds per head for one law restricts medicated feed containing feeding. this veterinary feed directive (VFD) (3) Amount per ton. Dichlorvos, 334–500 drug to use by or on the order of a ligrams (0.0366–0.0550 percent). censed veterinarian. See § 558.6 for addi- (i) Indications for use. An aid in im- tional requirements. proving litter production efficiency by (2) The expiration date of VFDs for increasing pigs born alive, birth erythromycin medicated feeds must weights, survival to market, and rate not exceed 6 months from the date of of weight gain. Treatment also re- issuance. VFDs for erythromycin shall moves and controls mature, immature not be refilled. and/or fourth stage larvae of whipworm (e) Conditions of use—(1) Chickens—

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Erythromycin in Combination in grams/ton grams/ton Indications for use Limitations Sponsor

(i) 92.5 ...... Chickens: As an aid in the preven- Feed for 2 days before stress 061623 tion of chronic respiratory disease and 3 to 6 days after during periods of stress. stress. Withdraw 24 hours before slaughter. (ii) 92.5 ...... Chickens: As an aid in the preven- Feed for 7 to 14 days. With- 061623 tion of infectious coryza. draw 24 hours before slaughter. (iii) 185 ...... Chickens: As an aid in the preven- Feed for 5 to 8 days. With- 061623 tion and reduction of lesions and draw 48 hours before in lowering severity of chronic slaughter. Do not use in respiratory disease (CRD). birds producing eggs for food.

(2) Turkeys—

Erythromycin thiocyanate in Combination in Indications for use Limitations Sponsor grams/ton grams/ton

(i) 92.5 ...... Turkeys: As an aid in the prevention Feed for 2 days before stress 061623 of chronic respiratory disease and 3 to 6 days after stress. during periods of stress. (ii) 185 ...... Turkeys: As an aid in the prevention Feed for 5 to 8 days. Do not 061623 and reduction of lesions and in use in birds producing eggs lowering severity of chronic res- for food. piratory disease (CRD).

[41 FR 10999, Mar. 15, 1976, as amended at 45 days; withdraw from dry dairy cows FR 56799, Aug. 26, 1980; 49 FR 31281, Aug. 6, and heifers 21 days prior to freshening; 1984; 51 FR 7397, Mar. 3, 1986; 52 FR 2684, Jan. withdraw 4 days prior to slaughter. 26, 1987; 54 FR 12189, Mar. 24, 1989; 66 FR 14074, (2) Amount. 2.3 milligrams per pound Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 79 FR 10982, Feb. 27, 2014; 81 FR 36790, June 8, 2016; body weight per day. 81 FR 95004, Dec. 27, 2016] (i) Indications for use. For control of grubs. § 558.254 Famphur. (ii) Limitations. For beef cattle and (a) Approvals. Type A medicated arti- nonlactating dairy cows; feed for 10 cles: 13.2 and 33.3 percent to 000061 in days; withdraw from dry dairy cows § 510.600(c) of this chapter. and heifers 21 days prior to freshening; (b) Special considerations. Famphur is withdraw 4 days prior to slaughter. a cholinesterase inhibitor. Do not use [41 FR 11000, Mar. 15, 1976, as amended at 51 this product in animals simultaneously FR 7397, Mar. 3, 1986; 57 FR 7652, Mar. 4, 1992; or within a few days before or after 62 FR 55161, Oct. 23, 1997; 62 FR 61626, Nov. 19, treatment with or exposure to cholin- 1997] esterase-inhibiting drugs, pesticides, or chemicals. § 558.258 Fenbendazole. (c) Related tolerances. See § 556.273 of (a) Specifications. Type A medicated this chapter. articles: 4 percent (18.1 grams per (d) Conditions of use. It is used in the pound (g/lb)), 8 percent (36.2 g/lb), and feed for cattle as follows: 20 percent (90.7 g/lb) fenbendazole. (1) Amount. 1.1 milligrams per pound (b) Approvals. See No. 000061 in body weight per day. § 510.600(c) of this chapter. (i) Indications for use. For control of (c) Related tolerances. See § 556.275 of grubs and as an aid in control of suck- this chapter. ing lice. (d) Special considerations. See § 500.25 (ii) Limitations. For beef cattle and of this chapter. nonlactating dairy cows; feed for 30 (e) Conditions of use—(1) Turkeys.

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Amount fenbendazole in Combination in Indications for use Limitations Sponsor grams per ton grams per ton

14.5 (16 parts per ...... Growing turkeys: For the removal and Feed continuously as the sole 000061 million). control of gastrointestinal worms: ration for 6 days. For growing roundworms, adult and larvae turkeys only. (Ascaridia dissimilis); cecal worms, adult and larvae (Heterakis gallinarum), an important vector of Histomonas meleagridis (Black- head).

(2) Swine.

Amount fenbendazole in Combination in Indications for use Limitations Sponsor grams per ton grams per ton

(i) 10 to 300 (to ...... For the removal and control of: Adult Feed as sole ration ...... 000061 provide 9 milli- stage lungworms (Metastrongylus grams per kilo- apri and M. pudendotectus); adult gram (mg/kg) and larvae (L3, 4 stages—liver, of body weight) lung, intestinal forms) large given over a 3- roundworms (Ascaris suum); adult to 12-day pe- stage nodular worms riod. (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus). (ii)–(v) [Reserved]. (vi) 10 to 300 (to Bacitracin Growing/finishing swine: As in para- Feed as sole ration. Under con- 054771 provide 9 mg/ methylenedisalicyl- graph (e)(2)(i) of this section; for in- ditions of continued exposure kg of body ate 10 to 30. creased rate of weight gain and im- to parasites, retreatment may weight). proved feed efficiency. be needed after 4 to 6 weeks. Bacitracin methylenedisalicylate as provided by 054771 in § 510.600(c) of this chapter. (vii) 10 to 300 (to Bacitracin 1. Growing/finishing swine: As in 1. Growing/finishing swine: 054771 provide 9 mg/ methylenedisalicyl- paragraph (e)(2)(i) of this section; Feed as sole ration. Not for kg of body ate 250. for control of swine dysentery asso- use in growing and finishing weight). ciated with Treponema swine that weigh more than hyodysenteriae on premises with a 250 lbs. Diagnosis of swine history of swine dysentery, but dysentery should be con- where signs of disease have not firmed by a veterinarian when yet occurred; or following an ap- results are not satisfactory. proved treatment of the disease Under conditions of contin- condition. ued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylenedisalicylate as provided by 054771 in § 510.600(c) of this chapter. 2. Pregnant sows: As in paragraph 2. Pregnant sows: Feed as sole (e)(2)(i) of this section; for control of ration. Diagnosis of clostridial clostridial enteritis in suckling pigs enteritis should be confirmed caused by Clostridium perfringens. by a veterinarian when results are not satisfactory. Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylenedisalicylate as provided by 054771 in § 510.600(c) of this chapter.

(3) Cattle.

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Amount fenbendazole Indications for use Limitations Sponsor

(i) 5 mg/kg Dairy and beef cat- Feed as the sole ration or as a top dress 000061 body weight tle: For the removal for one day. Retreatment may be needed (2.27 mg/lb) and control of: after 4 to 6 weeks. Cattle must not be Lungworms slaughtered within 13 days following last (Dictyocaulus treatment. For dairy cattle the milk discard viviparus); Stomach time is zero hours. A withdrawal period worms: barberpole has not been established for this product worms (Haemonchus in pre-ruminating calves. Do not use in contortus), brown calves to be processed for veal.. stomach worms (Ostertagia ostertagi), small stomach worms (Trichostrongylus axei); Intestinal worms: hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia oncophora and C. punctata); Bankrupt worms (Trichostrongylus colubriformis); and Nodular worms (Oesophagostomum radiatum). (ii) [Reserved]

(iii) Free-choice feeds—(A) Amount. 5 mg/kg body weight (2.27 mg/lb), including the following formulations:

Ingredient1 Percent International Feed No.

(1) Free-choice, dry Type C feed: Salt (sodium chloride) 59.00 6–04–152 Monosodium phosphate 31.16 6–04–288 Dried cane molasses 3.12 4–04–695 Zinc sulfate 0.76 6–05–556 Copper sulfate 0.45 6–01–720 Fenbendazole 20% Type A article 5.51 n/a (2) Free-choice, dry Type C feed: Salt (sodium chloride) 35.93 6–04–152 Dicalcium phosphate (18.5% P) 32.44 6–00–080 Calcium carbonate (38% Ca) 15.93 6–01–069 Magnesium oxide (56% Mg) 10.14 6–02–756 Zinc sulfate 1.47 6–05–556 Mineral oil 1.00 8–03–123 Dried cane molasses (46% sugars) 0.98 4–04–695 Potassium iodide 0.01 6–03–759 Fenbendazole 20% Type A article 2.10 n/a (3) Free-choice, liquid Type C feed: Cane molasses2 80.902 4–13–251 Water 9.36 n/a Urea solution, 55% 7.05 5–05–707 Phosphoric acid 75% (feed grade) 2.00 6–03–707 Xantham gum 0.20 8–15–818 Trace minerals 0.20 n/a Vitamin premix 0.01 n/a Fenbendazole 20% Type A article 0.278 n/a 1The content of any added vitamin and trace mineral may be varied; however, they should be comparable to those used by the manufacturer for other free-choice cattle feeds. Formulation modifications require FDA approval prior to marketing. Selenium is not approved for the free-choice formulations described in paragraph (e)(3)(iii) of this section. Free-choice cattle feeds containing selenium must comply with published regulations (see 21 CFR 573.920). 2The percentage of cane molasses and water in the formulation may be adjusted as needed in order to bring the brix value of the molasses to the industry standard of 79.5 brix.

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(B) Indications for use. As in para- slaughtered within 13 days following graph (e)(3)(i) of this section. last treatment. For dairy cattle the (C) Limitations. Feed a total of 5 mg milk discard time is zero hours. A of fenbendazole per kg (2.27 mg/lb) of withdrawal period has not been estab- body weight to cattle over a 3- to 6-day lished for this product in pre-rumi- period. Retreatment may be needed nating calves. Do not use in calves to after 4 to 6 weeks. Cattle must not be be processed for veal.

(4) Horses.

Amount fenbendazole in Indications for use Limitations Sponsor grams per ton

(i) 4,540 ...... 5 mg/kg body weight (2.27 mg/lb) for the con- Feed at the rate of 0. 1lb of feed per 100 lb of 000061 trol of large strongyles (Strongylus body weight to provide 2.27 mg edentatus, S. equinus, S. vulgaris, fenbendazole/lb of body weight in a 1-day Triodontophorus spp.), small strongyles treatment or 0.2 lb of feed per 100 lb of (Cyathostomum spp., Cylicocyclus spp., body weight to provide 4.54 mg Cylicostephanus spp.), and pinworms fenbendazole/lb of body weight in a 1-day (Oxyuris equi); 10 mg/kg body weight (4.54 treatment. All horses must be eating nor- mg/lb) for the control of ascarids mally to ensure that each animal consumes (Parascaris equorum).. an adequate amount of the medicated feed. Regular deworming at intervals of 6 to 8 weeks may be required due to the possibility of reinfection. Do not use in horses intended for human consumption.. (ii) [Reserved] ......

(5) Zoo and wildlife animals.

Amount Species/Class fenbendazole Indications for use Limitations Sponsor

(i) Feral swine 3 mg/kg/day for 3 For the removal and control of kidney Use as complete feed. Prior 000061 (Sus scrofa). days.. worm (Stephanurus dentatus), withdrawal of feed or water is roundworm (Ascaris suum), nodular not necessary. Retreatment worm (Oesophagostomum may be required in 6 weeks. dentatum). Do not use 14 days before or during the hunting season. (ii) Ruminants 2.5 mg/kg/day for 3 For the removal and control of small Use as complete feed. Prior 000061 (subfamily days.. stomach worm (Trichostrongylus withdrawal of feed or water is Antilopinae, spp.), thread necked intestinal not necessary. Retreatment Hippotraginae, worm (Nematodirus spp.), may be required in 6 weeks. Caprinae). barberpole worm (Haemonchus Do not use 14 days before or spp.), whipworm (Trichuris spp.). during the hunting season. (iii) Rocky moun- 10 mg/kg/day for 3 For the removal and control of Use as complete feed. Prior 000061 tain bighorn days.. Protostrongylus spp. withdrawal of feed or water is sheep (Ovis c. not necessary. Retreatment canadensis). may be required in 6 weeks. Do not use 14 days before or during the hunting season.

(6) Fenbendazole may also be used in § 558.261 Florfenicol. combination with: (a) Specifications. Type A medicated (i) [Reserved] articles containing florfenicol in the (ii) Lincomycin as in § 558.325. following concentrations: [66 FR 58935, Nov. 26, 2001, as amended at 68 (1) 40 grams per kilogram for use as FR 34534, June 10, 2003; 72 FR 66046, Nov. 27, in paragraph (e)(1) of this section. 2007; 73 FR 58873, Oct. 8, 2008; 74 FR 61517, (2) 500 grams per kilogram for use as Nov. 25, 2009; 79 FR 13545, Mar. 11, 2014; 81 FR in paragraph (e)(2) of this section. 17609, Mar. 30, 2016; 81 FR 95005, Dec. 27, 2016] (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

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(c) Related tolerances. See § 556.283 of (3) VFDs for florfenicol shall not be this chapter. refilled. (d) Special considerations—(1) Federal (4) Type A medicated articles and law restricts medicated feed containing medicated feeds intended for use in fish this veterinary feed directive (VFD) shall bear the following: ‘‘Not for use drug to use by or on the order of a li- in animals intended for breeding pur- censed veterinarian. See § 558.6 for addi- poses. The effects of florfenicol on re- tional requirements. productive performance have not been (2) The expiration date of VFDs for determined. Toxicity studies in dogs, florfenicol medicated feeds: rats, and mice have associated the use (i) For swine must not exceed 90 days from the date of issuance. of florfenicol with testicular degenera- (ii) For fish must not exceed 6 tion and atrophy.’’ months from the date of issuance. (e) Conditions of use—(1) Swine—

Florfenicol in grams/ton of feed Indications for use Limitations

182 ...... For the control of swine respiratory disease Feed continuously as a sole ration for 5 con- (SRD) associated with Actinobacillus secutive days. The safety of florfenicol on pleuropneumoniae, Pasteurella multocida, swine reproductive performance, pregnancy, Streptococcus suis, and Bordetella and lactation have not been determined. bronchiseptica in groups of swine in buildings Feeds containing florfenicol must be withdrawn experiencing an outbreak of SRD.. 13 days prior to slaughter.

(2) Fish—

Florfenicol in grams/ton of feed Indications for use Limitations

(i) 182 to 2,724 ...... Catfish: For the control of mortality due to enteric Feed as a sole ration for 10 consecutive days to septicemia of catfish associated with deliver 10 to 15 milligrams (mg) florfenicol per Edwardsiella ictaluri. kilogram (kg) of fish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. A dose- related decrease in hematopoietic/ lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter.

(ii) 182 to 1,816 ...... Freshwater-reared salmonids: For the control of Feed as a sole ration for 10 consecutive days to mortality due to coldwater disease associated deliver 10 to 15 mg florfenicol per kg of fish. with Flavobacterium psychrophilum and furun- Feed containing florfenicol shall not be fed for culosis associated with Aeromonas more than 10 days. Following administration, salmonicida. fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter.

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Florfenicol in grams/ton of feed Indications for use Limitations

(iii) 182 to 2,724 ...... Freshwater-reared finfish: For the control of mor- Feed as a sole ration for 10 consecutive days to tality due to columnaris disease associated deliver 10 to 15 mg florfenicol per kg of fish for with Flavobacterium columnare. freshwater-reared warmwater finfish and other freshwater-reared finfish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, a dose-related decrease in hematopoietic/ lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter.

(iv) 273 to 2,724 ...... Freshwater-reared warmwater finfish: For the Feed as a sole ration for 10 consecutive days to control of mortality due to streptococcal septi- deliver 15 mg florfenicol per kg of fish. Feed cemia associated with Streptococcus iniae. containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/ lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter.

[70 FR 70047, Nov. 21, 2005, as amended at 71 FR 70304, Dec. 4, 2006; 72 FR 19798, Apr. 20, 2007; 72 FR 65885, Nov. 26, 2007; 77 FR 32012, May 31, 2012; 79 FR 18159, Apr. 1, 2014; 80 FR 76387, Dec. 9, 2015; 81 FR 17609, Mar. 30, 2016; 81 FR 67152, Sept. 30, 2016]

§ 558.265 Halofuginone. tenella, E. necatrix, E. acervulina, E. (a) Specifications. Type A medicated brunetti, E. mivati, and E. maxima; for articles containing 6 grams of increased rate of weight gain and im- halofuginone hydrobromide per kilo- proved feed efficiency. gram. (B) Limitations. Feed continuously as (b) Approvals. See No. 016592 in sole ration; withdraw 5 days before § 510.600(c) of this chapter. slaughter; do not feed to layers. (c) Related tolerances. See § 556.308 of (iii)–(v) [Reserved] this chapter. (vi) Amount per ton. Halofuginone 2.72 (d) Conditions of use. (1) It is used in grams (0.0003 percent) plus bacitracin feed for broiler chickens as follows: methylenedisalicylate 10 to 50 grams. (i) Amount. 2.72 grams per ton. (A) Indications for use. For the pre- (A) Indications for use. For the prevention of coccidiosis caused by Eimeria vention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mevati, E. maxima and for brunetti, E. mivati, and E. maxima. improved feed efficiency. (B) Limitations. Feed continuously as (B) Limitations. Feed continuously as sole ration; withdraw 4 days before sole ration; withdraw 5 days before slaughter; do not feed to layers; avoid slaughter; do not feed to layers; avoid contact with skin, eyes, or clothing; contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams. keep out of lakes, ponds, or streams. (ii) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus (vii)–(viii) [Reserved] bambermycins 1 to 2 grams. (2) It is used in feed for turkeys as (A) Indications for use. For the pre- follows: vention of coccidiosis caused by Eimeria (i) Amount per ton. 1.36 to 2.72 grams.

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(A) Indications for use. For the pre- (B) Limitations. Feed continuously as vention of coccidiosis in growing tur- sole ration to replacement cage laying keys caused by Eimeria adenoeides, E. chickens until 20 weeks of age. Feed meleagrimitis, and E. gallopavonis. continuously as sole ration to replace- (B) Limitations. Feed continuously as ment broiler breeder chickens until 16 sole ration; withdraw 7 days before weeks of age. Withdraw 4 days before slaughter; do not feed to layers or slaughter. Do not feed to laying chick- water fowl; avoid contact with skin, ens or water fowl. Halofuginone eyes, or clothing; keep out of lakes, hydrobromide is toxic to fish and ponds, or streams. aquatic life. Keep out of lakes, ponds, (ii) Amount per ton. Halofuginone and streams. Halofuginone hydrobromide 1.36 to 2.72 grams plus hydrobromide is an irritant to eyes and bacitracin methylenedisalicylate 10 to skin. Avoid contact with skin, eyes, 50 grams. and clothing. (A) Indications for use. For prevention (ii) [Reserved] of coccidiosis caused by Eimeria (4) Halofuginone may also be used in adenoeides, E. meleagrimitis., and E. combination with: gallopavonis, and for increased rate of (i) [Reserved] weight gain in growing turkeys. (ii) Lincomycin as in § 558.325. (B) Limitations. Feed continuously as (iii) Virginiamycin as in § 558.635. sole ration. Withdraw 7 days before [50 FR 33719, Aug. 21, 1985, as amended at 50 slaughter. Do not feed to laying chick- FR 42518, Oct. 21, 1985; 51 FR 7397, Mar. 3, ens or water fowl. Keep out of lakes, 1986; 51 FR 11439, Apr. 3, 1986; 51 FR 14989, ponds, and streams. Halofuginone is Apr. 22, 1986; 51 FR 23737, July 1, 1986; 53 FR toxic to fish and aquatic life. 1018, Jan. 15, 1988; 53 FR 11065, Apr. 5, 1988; 54 Halofuginone is an irritant to eyes and FR 11519, Mar. 21, 1989; 54 FR 28052, July 5, skin. Avoid contact with skin, eyes, or 1989; 59 FR 51498, Oct. 12, 1994; 61 FR 21076, clothing. May 9, 1996; 61 FR 24694, May 16, 1996; 64 FR 42597, Aug. 5, 1999; 65 FR 45712, July 25, 2000; (iii) Amount per ton. 1.36 to 2.72 grams 66 FR 47962, Sept. 17, 2001; 71 FR 27956, May of halofuginone hydrobromide plus 2 15, 2006; 79 FR 10982, Feb. 27, 2014; 81 FR 17609, grams of bambermycins. Mar. 30, 2016; 81 FR 95005, Dec. 27, 2016] (A) Indications for use. For the prevention of coccidiosis caused by Eimeria § 558.274 Hygromycin B. adenoides, E. meleagrimitis, and E. (a) Specifications. Type A medicated gallopavonis, and for increased rate of articles containing 2.4 or 8 grams weight gain in growing turkeys. hygromycin B per pound (g/lb). (B) Limitations. Feed continuously as (b) Sponsor. See No. 058198 in sole ration. Withdraw 7 days before § 510.600(c) of this chapter for as fol- slaughter. Do not feed to laying chick- lows: ens or waterfowl. Halofuginone (c) Related tolerances. See § 556.330 of hydrobromide is toxic to fish and other this chapter. aquatic life. Keep out of lakes, ponds, (d) Special considerations. (1) Federal and streams. Halofuginone law restricts medicated feed containing hydrobromide is an eye and skin irri- this veterinary feed directive (VFD) tant. Avoid contact with skin, eyes, drug to use by or on the order of a li- and clothing. censed veterinarian. See § 558.6 for addi- (3) It is used in feed for replacement tional requirements. cage laying chickens and replacement (2) The expiration date of VFDs for broiler breeder chickens as follows: hygromycin B medicated feeds must (i) Amount per ton. 2.72 grams. not exceed 6 months from the date of (A) Indications for use. For the pre- issuance. VFDs for hygromycin B shall vention of coccidiosis caused by Eimeria not be refilled. tenella, E. necatrix, E. acervulina, E. (e) Conditions of use. It is used in feed maxima, E. mivati/E. mitis, and E. as follows: brunetti. (1) Chickens—

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Hygromycin B grams/ Combination in ton grams/ton Indications for use Limitations Sponsor

(i) 8 to 12 ...... Chickens: For control of infec- Use in complete feed. Withdraw 058198 tions of large roundworms 3 days before slaughter. (Ascaris galli), cecal worms (Heterakis gallinae), and capillary worms (Capillaria obsignata). (ii) [Reserved]

(2) Swine—

Hygromycin B grams/ Combination in ton grams/ton Indications for use Limitations Sponsor

(i) 12 ...... Swine: For control of infections In market hogs, use in complete 058198 of large roundworms (A. suis), feed for 8 weeks during the nodular worms (O. dentatum), growing period. Withdraw 15 and whipworms (Trichuris days before slaughter. suis). (ii) [Reserved]

[81 FR 95005, Dec. 27, 2016] phase of lactation. Administration must be accompanied with increased § 558.295 Iodinated casein. feed intake; administration may in- (a) Approvals. See 017762 in § 510.600(c) crease heat sensitivity of the animal. of this chapter. [45 FR 41631, June 20, 1980, as amended at 81 (b) [Reserved] FR 67152, Sept. 30, 2016] (c) Conditions of use—(1) Ducks—(i) Amount per ton. 100 to 200 grams. § 558.300 Ivermectin. (ii) Indications for use. For increased (a) Specifications. Type A medicated rate of weight gain and improved feath- article containing 2.72 grams ering in growing ducks. ivermectin per pound (g/lb). (2) Dairy cows—(i) Amount per pound. (b) Sponsor. See No. 050604 in 1⁄2 to 11⁄2 grams per 100 lb of body § 510.600(c) of this chapter. weight. (c) Related tolerances. See § 556.344 of (ii) Indications for use. For increased this chapter. milk production in dairy cows. (d) Special considerations. See § 500.25 (iii) Limitations. This drug is effective of this chapter. for limited periods of time, and the ef- (e) Conditions of use in swine. It is fectiveness is limited to the declining used in feed as follows:

Ivermectin in Combination in g/ g/ton of feed ton of feed Indications for use Limitations Sponsor

(1) 1.8 (to Weaned, growing-finishing swine: Feed as the only feed for 7 con- 050604 provide 0.1 For treatment and control of gas- secutive days. Withdraw 5 days milligram trointestinal roundworms (Ascaris before slaughter. per kilo- suum, adults and fourth-stage lar- gram (mg/ vae; Ascarops strongylina, adults; kg) of body Hyostrongylus rubidus, adults and weight per fourth-stage larvae; day) Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis).

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Ivermectin in Combination in g/ g/ton of feed ton of feed Indications for use Limitations Sponsor

(2) 1.8 (to Bacitracin Weaned, growing-finishing swine: For use in swine feed only. Feed as 050604 provide 0.1 methylenedisalicy- As in paragraph (e)(1) of this sec- the only feed for 7 consecutive mg/kg of late, 10 to 30 tion; and for increased rate of days. Withdraw 5 days before body weight gain and improved feed ef- slaughter. weight per ficiency. day)

(3) 1.8 (to Bacitracin Weaned, growing-finishing swine: For use in swine feed only. Feed as 050604 provide 0.1 methylenedisalicy- As in paragraph (e)(1) of this sec- the only feed for 7 consecutive mg/kg of late, 250 tion; and for control of swine dys- days. Withdraw 5 days before body entery associated with slaughter. weight per Treponema hyodysenteriae on day) premises with a history of swine dysentery, but where symptoms have not yet occurred, or following an approved treatment of disease condition.

(4)–(7) [Re- served]

(8) 1.8 to Adult and breeding swine: For treat- Feed as the only feed for 7 con- 050604 11.8 (to ment and control of gastro- secutive days. Withdraw 5 days provide 0.1 intestinal roundworms (Ascaris before slaughter. mg/kg of suum, adults and fourth-stage lar- body vae; Ascarops strongylina, adults; weight per Hyostrongylus rubidus, adults and day) fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis).

(9) 1.8 to Bacitracin Pregnant sows: As in paragraph Feed as the only feed for 7 con- 050604 11.8 (to methylenedisalicy- (e)(8) of this section; and for consecutive days. Withdraw 5 days provide 0.1 late, 250 trol of clostridial enteritis caused before slaughter. Feed bacitracin mg/kg of by Clostridium perfringens in methylenedisalicylate Type C body suckling piglets. medicated feed to sows from 14 weight per days before through 21 days after day) farrowing on premises with a history of clostridial scours.

(10) 18.2 to Adult and breeding swine: As in Top dress on daily ration for indi- 050604 120 (to paragraph (e)(8) of this section. vidual treatment for 7 consecutive provide 0.1 days. Withdraw 5 days before mg/kg of slaughter. body weight per day)

(f) Ivermectin may also be used in § 558.305 Laidlomycin. combination with: (a) Specifications. Type A medicated (1) [Reserved] articles containing 50 grams (2) Lincomycin as in § 558.325. laidlomycin propionate potassium per [72 FR 37437, July 10, 2007, as amended at 81 pound. FR 17609, Mar. 30, 2016; 81 FR 95005, Dec. 27, (b) Approvals. See No. 054771 in 2016] § 510.600(c) of this chapter.

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(c) Tolerances. See § 556.346 of this top. Agitate daily as described even chapter. when not used. (d) Special considerations. (1) (2) The expiration date for the liquid Laidlomycin liquid Type B feeds may Type B feed is 21 days after date of be manufactured from dry laidlomycin manufacture. The expiration date for Type A articles. The liquid Type B the dry Type C feed made from the liq- feeds must have a pH of 6.0 to 8.0, dry uid Type B feed is 7 days after date of matter of 62 to 75 percent, and bear ap- manufacture. propriate mixing directions as follows: (3) Labeling for all Type B feeds (liq- (i) For liquid feeds stored in recircu- uid and dry) and Type C feeds con- lating tank systems: Recirculate im- taining laidlomycin shall bear the fol- mediately prior to use for no less than lowing statements: 10 minutes, moving not less than 1 per- (i) Do not allow horses or other cent of the tank contents per minute equines access to feeds containing from the bottom of the tank to the top. laidlomycin propionate potassium. Recirculate daily as described even (ii) The safety of laidlomycin propio- when not used. nate potassium in unapproved species (ii) For liquid feeds stored in me- has not been established. chanical, air, or other agitation type (iii) Not for use in animals intended tank systems: Agitate immediately for breeding. prior to use for not less than 10 min- (e) Conditions of use. It is used in cat- utes, creating a turbulence at the bottle being fed in confinement for slaugh- tom of the tank that is visible at the ter as follows:

Laidlomycin in Combination in grams per ton grams per ton Indications for use Limitations Sponsor

(1) 5 ...... For improved feed efficiency and in- Feed continuously in a Type C 054771 creased rate of weight gain.. feed at a rate of 30 to 75 mg/ head/day.. (2) 5 to 10 ...... For improved feed efficiency...... Feed continuously in a Type C 054771 feed at a rate of 30 to 150 milligrams/head/day..

(f) Laidlomycin may also be used in (2) 15 percent activity to No. 066104 as combination with chlortetracycline as provided by No. 054771 for use as in in § 558.128. paragraph (e)(1)(v) of this section. (3) 15, 20, 33.1, and 50 percent activity [59 FR 18297, Apr. 18, 1994, as amended at 60 to No. 054771 for use in cattle feeds as FR 53509, Oct. 16, 1995; 62 FR 9929, Mar. 5, in paragraphs (e)(1)(vi), (vii), (ix), (xi), 1997; 63 FR 27845, May 21, 1998; 66 FR 46706, (xii), and (xv) of this section, and for Sept. 7, 2001; 68 FR 13839, Mar. 21, 2003; 68 FR 42590, July 18, 2003; 69 FR 30198, May 27, 2004; use in sheep as in paragraph (e)(1)(viii) 79 FR 13545, Mar. 11, 2014; 81 FR 95005, Dec. 27, of this section. 2016] (4) 15 percent activity to No. 054771 for use in Type C rabbit feeds as in § 558.311 Lasalocid. paragraph (e)(1)(xvi) of this section and for use in ruminant free-choice Type C (a) Specifications. A minimum of 90 feeds as in paragraphs (e)(2), (e)(3), and percent of lasalocid activity is derived (e)(4) of this section. from lasalocid A. (5) 15 and 20 percent activity to Nos. (b) Approvals. Type A medicated arti- 012286 and 017800 for use in free-choice cles approved for sponsors identified in mineral feeds for cattle as in paragraph § 510.600(c) of this chapter for use as in (e)(1)(xviii) of this section. paragraph (e) of this section as follows: (6) 20 percent activity as a liquid (1) 3.0, 3.3, 3.8, 4.0, 4.3, 4.4, 5.0, 5.1, 5.5, Type A article to No. 054771 for use in 5.7, 6.0, 6.3, 6.7, 7.2, 7.5, 8.0, 8.3, 10.0, 12.5, cattle feeds as in paragraphs (e)(1)(vi), 15, 20, and 50 percent activity to No. (e)(1)(vii), (e)(1)(ix), (e)(1)(xi), (e)(1)(xii), 054771 for use as in paragraphs (e)(1) (i), and (e)(3) of this section, and for use in (ii), (iii), (iv), and (x) of this section. sheep feeds as in paragraph (e)(1)(viii) of this section.

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(7) 20 percent activity to No. 054771 supplemental new animal drug applica- for use as follows: tion to establish physical stability; and (i) Chukar partridges as in paragraph (iii) Requesting the sponsor of an ap- (e)(1)(xiii). proved new animal drug application to (ii) Turkeys as in paragraph file a supplement to provide for use of (e)(1)(xiv). its lasalocid Type A article in the man- (iii) Rabbits as in paragraph ufacture of the liquid feed specified in (e)(1)(xvi). the appropriate master file. If the data (8) [Reserved] demonstrate the stability of the liquid (9) 15 percent activity to No. 068287 feed described in the master file, the for use in free-choice protein blocks for supplemental new animal drug applica- cattle as in paragraphs (e)(1)(xix) of tion will be approved. The approval this section. will provide a basis for the individual (c) Related tolerance. See § 556.347 of liquid feed manufacturer to manufac- this chapter. ture under a medicated feed license the (d) Special considerations. (1) Type C liquid mediated feed described in the cattle and sheep feeds may be manufac- master file. A manufacturer who seeks tured from lasalocid liquid Type B to market a physically unstable feeds which have a pH of 4.0 to 8.0 and lasalocid liquid feed with mixing direc- bear appropriate mixing directions as tions different from the standard direc- follows: tions established in paragraph (d)(1) of (i) For liquid feeds stored in recircu- this section may also follow this proce- lating tank systems: Recirculate im- dure. mediately prior to use for no less than (4) If adequate information is sub- 10 minutes, moving not less than 1 permitted to show that a particular liquid cent of the tank contents per minute feed containing lasalocid is stable out- from the bottom of the tank to the top. side the pH of 4.0 to 8.0, the pH restric- Recirculate daily as described even tion described in paragraphs (d)(1) and when not used. (d)(2) of this section may be waived. (ii) For liquid feeds stored in me- (5) Required label statements: chanical, air, or other agitation-type (i) For liquid Type B feed (cattle and tank systems: Agitate immediately sheep): Mix thoroughly with grain and/ prior to use for not less than 10 min- or roughage prior to feeding. Feeding utes, creating a turbulence at the bot- undiluted, mixing errors, or inadequate tom of the tank that is visible at the mixing (recirculation or agitation) top. Agitate daily as described even may result in an excess lasalocid con- when not used. centration which could be fatal to cat- (2) A physically stable lasalocid liq- tle and sheep. Do not allow horses or uid feed will not be subject to the re- other equines access to Type A articles quirements for mixing directions pre- or Type B feeds containing lasalocid as scribed in paragraph (d)(1) of this sec- ingestion may be fatal. Safety of tion provided it has a pH of 4.0 to 8.0 lasalocid for use in unapproved species and contains a suspending agent(s) suf- has not been established. ficient to maintain a viscosity of not (ii) For Type A articles or Type B less than 300 centipoises per second for feeds (cattle and sheep): Feeding undi- 3 months. luted or mixing errors may result in an (3) If a manufacturer is unable to excess lasalocid concentration which meet the requirements of paragraph could be fatal to cattle and sheep. Do (d)(1) or (d)(2) of this section, the man- not allow horses or other equines ac- ufacturer may secure approval of a cess to Type A articles or Type B feeds positionally stable liquid feed by: containing lasalocid as ingestion may (i) Either filing a new animal drug be fatal. Safety of lasalocid for use in application for the product or estab- unapproved species has not been establishing a master file containing data to lished. support the stability of its product; (iii) For Type A articles, Type B or (ii) Authorizing the agency to ref- Type C feeds (cattle): A withdrawal pe- erence and rely upon the data in the riod has not been established for this master file to support approval of a product in preruminating calves. Do

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not use in calves to be processed for and (e)(1)(xviii) of this section must be veal. the subject of an approved NADA or (6) Lasalocid Type A medicated arti- supplemental NADA as provided in cles containing lasalocid dried fer- § 510.455 of this chapter. mentation residue are for use in cattle (e)(1) Conditions of use. It is used as and sheep feed only. follows: (7) Each use in a free-choice Type C cattle feed as in paragraphs (e)(1)(xii)

Lasalocid sodium activity in grams Combination in Indications for use Limitations Sponsor per ton grams per ton

(i) 68 (0.0075 pct) ...... For the prevention of coccidiosis For broiler or fryer chickens 054771 to 113 (0.0125 caused by Eimeria tenella, E. only; feed continuously as pct). necatrix, E. acervulina, E. brunetti, the sole ration. E. mivati, and E. maxima. (ii) 68 (0.0075 Bambermycins 1 to 2 Broiler chickens: For prevention of Feed continuously as sole ra- 016592 pct) to 113 coccidiosis caused by Eimeria tion. Bambermycins provided (0.0125 pct). tenella, E. necatrix, E. acervulina, by No. 016592 in E. brunetti, E. mivati, and E. maxi- § 510.600(c) of this chapter.. ma; and for increased rate of weight gain and improved feed efficiency.. (iii) [Reserved]. (iv) 68 (0.0075 Bacitracin 10 to 50 .. For prevention of coccidiosis caused For broiler or fryer chickens 054771 percent). by Eimeria tenella, E. necatrix, E. only; feed continuously as acervulina, E. brunetti, E. mivati, the sole ration; bacitracin and E. maxima, and for increased methylenedisalicylate pro- rate of weight gain and improved vided by No. 054771 in feed efficiency. § 510.600(c) of this chapter. (v) [Reserved]. (vi) 10 (0.0011 ...... Cattle; for improved feed efficiency .... In Type C feeds; for cattle fed 054771 pct) to 30 in confinement for slaughter (0.0033 pct). only; feed continuously in complete feed to provide not less than 100 mg nor more than 360 mg of lasalocid sodium activity per head per day. (vii) 25 (0.0027 ...... Cattle; for improved feed efficiency In Type C feeds; for cattle fed 054771 pct) to 30 and increased rate of weight gain. in confinement for slaughter (0.0033 pct). only; feed continuously in complete feed to provide not less than 250 mg nor more than 360 mg of lasalocid sodium activity per head per day. (viii) 20 (0.0022 ...... Sheep; for the prevention of coccidi- In Type C feeds; for sheep 054771 pct) to 30 osis caused by Eimeria ovina, E. maintained in confinement; (0.0033 pct). crandallis, E. ovinoidalis (E. feed continuously in complete ninakohlyakimovae), E. parva, and feed to provide not less than E. intricata. 15 mg nor more than 70 mg of lasalocid sodium activity per head per day depending on body weight. (ix) ...... Pasture cattle (slaughter, stocker, Feed continuously at a rate of 054771 feeder cattle, and dairy and beef re- not less than 60 mg or more placement heifers): for increased than 300 mg of lasalocid per rate of weight gain. Intakes of head per day when on pas- lasalocid in excess of 200 mg/head/ ture; the drug must be con- day have not been shown to be tained in at least 1 pound of more effective than 200 mg/head/ feed.. day.. (x) 68 (0.0075 Bacitracin 4 to 50.... Broiler chickens; for prevention of For broiler chickens only; feed 054771 pct) to 113 coccidiosis caused by Eimeria continuously as the sole ra- (0.0125 pct). tenella, E. necatrix, E. acervulina, tion; bacitracin E. brunetti, E. mivati, and E. maxi- methylenedisalicylate pro- ma; and for improved feed effi- vided by No. 054771 in ciency. § 510.600(c) of this chapter.

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Lasalocid sodium activity in grams Combination in Indications for use Limitations Sponsor per ton grams per ton

(xi) 68 (0.0075 Bacitracin zinc 4 to Broiler chickens. For prevention of Feed continuously as sole ra- 054771 pct) to 113 50. coccidiosis caused by Eimeria tion. Bacitracin zinc and (0.0125 pct). tenella, E. necatrix, E. acervulina, lasalocid sodium as provided E. brunetti, E. mivati, and E. maxi- by No. 054771 in ma, and for increased rate of § 510.600(c) of this chapter.. weight gain and improved feed efficiency.. (xii) ...... Pasture cattle (slaughter, stocker, Feed continuously on a free- 054771 feeder cattle, and dairy and beef re- choice basis at a rate of not placement heifers): For increased less than 60 mg or more than rate of weight gain. Intakes of 300 mg of lasalocid per head lasalocid in excess of 200 mg/head/ per day.. day have not been shown to be more effective than 200 mg/head/ day.. (xiii) ...... Cattle; for control of coccidiosis For cattle; hand feed at a rate 054771 caused by Eimeria bovis and of 1 mg of lasalocid per 2.2 Eimeria zuernii. pounds body weight per day to cattle weighing up to 800 pounds with a maximum of 360 mg of lasalocid per head per day. (xiv) 113 (0.0125 ...... Chukar partridges; for prevention of Feed continuously as sole ra- 054771 pct). coccidiosis caused by Eimeria tion up to 8 weeks of age. legionensis. (xv) 68 (0.0075 ...... Growing turkeys; for prevention of Feed continuously as sole ra- 054771 pct) to 113 coccidiosis caused by E. tion. (0.0125 pct). meleagrimitis, E. gallopavonis, and E. adenoeides...... Bacitracin 4 to 50 .... Growing turkeys; for prevention of Feed continuously as sole ra- 054771 coccidiosis caused by E. tion. meleagrimitis, E. gallopavonis, and E. adenoeides; for increased rate of weight gain and improved feed efficiency...... Bacitracin Growing turkeys; for prevention of Feed continuously as sole ra- 054771 methylenedisalicyl- coccidiosis caused by E. tion. Bacitracin ate 4 to 50. meleagrimitis, E. gallopavonis, and methylenedisalicylate as pro- E. adenoeides; for increased rate of vided by No. 054771 in weight gain and improved feed effi- § 510.600(c) of this chapter.. ciency.. (xvi) ...... Replacement calves; for control of In milk replacer powder; hand 054771 coccidiosis caused by E. bovis and feed at a rate of 1 mg of E. zuernii.. lasalocid per 2.2 lb body weight per day; include on labeling warning: ‘‘A withdrawal period has not been established for lasalocid in pre-ruminating calves. Do not use in calves to be processed for veal’’. (xvii) 113 (0.0125 ...... Rabbits; for prevention of coccidiosis Feed continuously as sole ra- 054771 pct). caused by Eimeria stiedae. tion up to 61⁄2 weeks of age. (xviii) 1440...... Pasture cattle (slaughter, stocker, Feed continuously on a free- 021930 feeder cattle, and dairy and beef re- choice basis at a rate of not 017800 placement heifers): For increased less than 60 mg nor more rate of weight gain.. than 200 mg of lasalocid per head per day.. (xix) 300...... Pasture cattle (slaughter, stocker, Feed continuously on a free- 068287 feeder cattle, and dairy and beef re- choice basis at a rate of not placement heifers): for increased less than 60 mg nor more rate of weight gain.. than 200 mg of lasalocid per head per day.. (xx)–(xxviii) [Re- served].

(2) It is used as a free-choice mineral (i) Specifications. Type C feed as follows:

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Ingredient Percent International feed No.

Defluorinated phosphate (20.5% Ca, 18.5% P) ...... 35 .9 6–01–080 Sodium chloride (salt) ...... 20 .0 6–04–152 Calcium carbonate (38% Ca) ...... 18.0 6–01–069 Cottonseed meal ...... 10 .0 5–01–621 Potassium chloride ...... 3.0 6–03–755 Selenium premix (0.02 percent Se)1 ...... 3 .0 Dried cane molasses (46% sugars) ...... 2.5 4–04–695 Magnesium sulfate ...... 1 .7 6–02–758 Vitamin premix1 ...... 1 .4 Magnesium oxide (58% Mg) ...... 1 .2 6–02–756 Potassium sulfate ...... 1 .2 6–06–098 Trace mineral premix1 ...... 1 .04 Lasalocid Type A medicated article (68 g/lb)2 ...... 1 .06 1 Content of the vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the firm for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18). 2 To provide 1,440 g lasalocid per ton, use 21.2 lbs (1.06%) of a lasalocid Type A medicated article containing 68 g/lb. If using a lasalocid Type A medicated article containing 90.7 g/lb, use 15.88 lbs per ton (0.794%), adding molasses.

(ii) Amount. 1,440 grams per ton. dairy and beef replacement heifers); (iii) Indications for use. Pasture cattle feed continuously on a free-choice (slaughter, stocker, feeder cattle, and basis at a rate of 60 to 300 milligrams dairy and beef replacement heifers): for lasalocid per head per day. increased rate of weight gain. Intakes (v) Sponsor. See No. 054771 in of lasalocid in excess of 200 mg/head/ § 510.600(c) of this chapter. day have not been shown to be more ef- (3) It is used as a ruminant free- fective than 200 mg/head/day. choice liquid Type C feed as follows: (iv) Limitations. For pasture cattle (slaughter, stocker, feeder cattle, and (i) Specifications.

Ingredient Percent International feed No.

Cane molasses ...... 55.167 4–13–241 Condensed molasses fermentation solubles ...... 24.0 50% Urea Solution (23% N) ...... 12 .0 Ammonium polyphosphate solution ...... 1.0 6–08–42 Phosphoric acid (54%) ...... 3 .0 6–03–707 Xanthan gum ...... 0 .05 8–15–818 Water ...... 4.0 Trace mineral premix1 ...... 0 .5 Vitamin premix1 ...... 0 .2 Lasalocid Type A medicated article (90.7 g/lb)2 ...... 0 .083 1 Content of the vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the firm for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18). 2 To provide 150 gm lasalocid per ton, use 1.652 lb (0.083%) of a lasalocid liquid Type A medicated article containing 90.7 g/ lb. If using a dry lasalocid Type A medicated article containing 68 g/lb, use, use 2.206 lbs per ton (0.111%), replacing molasses. If using a dry lasalocid Type A medicated article containing 90.7 g/lb, use 1.652 lbs per ton (0.083%), adding molasses.

(ii) Amount. 150 grams per ton. dairy and beef replacement heifers). (iii) Indications for use. Pasture cattle Feed continuously on a free-choice (slaughter, stocker, feeder cattle, and basis at a rate of 60 to 300 milligrams dairy and beef replacement heifers): for lasalocid per head per day. increased rate of weight gain. Intakes (v) Sponsor. See No. 054771 in of lasalocid in excess of 200 mg/head/ § 510.600(c) of this chapter. day have not been shown to be more ef- (4) It is used as a free-choice, loose fective than 200 mg/head/day. mineral Type C feed as follows: (iv) Limitations. For pasture cattle (i) Specifications. (slaughter, stocker, feeder cattle, and

Ingredient Percent International feed No.

Monocalcium phosphate (21% P) ...... 57 .70 6–01–082

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Ingredient Percent International feed No.

Salt ...... 17 .55 6–04–152 Distillers dried grains w/ solubles ...... 5 .40 5–28–236 Dried cane molasses (46% Sugars) ...... 5.20 4–04–695 Potassium chloride ...... 4.90 6–03–755 Trace mineral/vitamin premix1 ...... 3.35 Calcium carbonate (38% Ca) ...... 2.95 6–01–069 Mineral oil ...... 1 .05 8–03–123 Magnesium oxide (58% Mg) ...... 1 .00 6–02–756 Iron oxide (52% Fe) ...... 0 .10 6–02–431 Lasalocid Type A medicated article (68 g/lb)2 ...... 0 .80 1 Content of the vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the firm for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18). 2 To provide 1,088 g lasalocid per ton, use 16 lbs (0.80%) of a lasalocid Type A medicated article containing 68 g/lb. If using a lasalocid Type A medicated article containing 90.7 g/lb, use 12 lbs per ton (0.6%), adding molasses.

(ii) Amount. 1,088 grams per ton. (d) Special considerations. (1) Federal (iii) Indications for use. Pasture cattle law restricts medicated feed containing (slaughter, stocker, feeder cattle, and this veterinary feed directive (VFD) dairy and beef replacement heifers): drug to use by or on the order of a li- For increased rate of weight gain. In- censed veterinarian. See § 558.6 for addi- takes of lasalocid in excess of 200 mg/ tional requirements. head/day have not been shown to be (2) The expiration date of VFDs for more effective than 200 mg/head/day. lincomycin medicated feeds must not (iv) Limitations. Feed continuously on exceed 6 months from the date of a free-choice basis at a rate of 60 to 300 issuance. VFDs for lincomycin shall mg lasalocid per head per day. not be refilled. (v) Sponsor. See No. 054771 in (3) Labeling of Type A medicated ar- § 510.600(c) of this chapter. ticles and Type B and Type C medi- (5) Lasalocid may also be used in cated feeds containing lincomycin combination with: shall bear the following: (i) Chlortetracycline as in § 558.128. (i) ‘‘CAUTION: Do not allow rabbits, (ii) Melengestrol acetate alone or in hamsters, guinea pigs, horses, or combination with tylosin as in § 558.342. ruminants access to feeds containing (iii) Virginiamycin as in § 558.635. lincomycin. Ingestion by these species may result in severe gastrointestinal [41 FR 44382, Oct. 8, 1976] effects.’’ EDITORIAL NOTES: 1. For FEDERAL REGISTER (ii) [Reserved] citations affecting § 558.311, see the List of (4) Labeling of medicated feeds con- CFR Sections Affected, which appears in the taining lincomycin intended for use in Finding Aids section of the printed volume swine shall bear the following: and at www.fdsys.gov. (i) ‘‘CAUTION: Occasionally, swine 2. At 79 FR 13545, Mar. 11, 2014, § 558.311 was fed lincomycin may within the first 2 amended; however, the amendment could not days after the onset of treatment de- be incorporated because of the inaccurate velop diarrhea and/or swelling of the amendatory instruction. anus. On rare occasions, some pigs may show reddening of the skin and irri- § 558.325 Lincomycin. table behavior. These conditions have (a) Specifications. Type A medicated been self-correcting within 5 to 8 days articles containing 20 or 50 grams of without discontinuing the lincomycin lincomycin (as lincomycin hydro- treatment.’’ chloride) per pound. (ii) ‘‘CAUTION: The effects of linco- (b) Sponsors. See No. 054771 in mycin on swine reproductive perform- § 510.600(c) of this chapter. ance, pregnancy, and lactation have (c) Related tolerances. See § 556.360 of not been determined.’’ this chapter. (e) Conditions of use—(1) Chickens—

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Lincomycin Combination in grams/ton grams/ton Indications for use Limitations Sponsors

(i) 2 ...... Broilers: For the control of necrot- Feed as the sole ration. Not for 054771 ic enteritis caused or com- use in layers, breeders, or tur- plicated by Clostridium spp. or keys. other organisms susceptible to lincomycin. (ii) 2 ...... Halofuginone 2.72 .... Broiler chickens: For the control of Feed continuously as sole ration. 016592 necrotic enteritis caused or Withdraw 4 days before slaugh- complicated by Clostridium spp. ter. Do not feed to laying chick- or other organisms susceptible ens or waterfowl. Halofuginone to lincomycin; and the preven- hydrobromide as provided by tion of coccidiosis caused by No. 016592 in § 510.600 of this Eimeria tenella, E. necatrix, E. chapter. acervulina, E. brunetti, E. mivati, and E. maxima.

(2) Swine—

Lincomycin Combination in grams/ton grams/ton Indications for use Limitations Sponsors

(i) 40...... For control of swine dysentery Feed as sole ration. For use in 054771 and the control of porcine prolif- swine on premises with a his- erative enteropathies (ileitis) tory of swine dysentery but caused by Lawsonia where symptoms have not yet intracellularis. occurred, or following use of lincomycin at 100 grams (g)/ton for the treatment of swine dysentery and the control of porcine proliferative enteropathies (ileitis). (ii) 40 ...... Fenbendazole, 10 to For control of swine dysentery in Feed as sole ration to provide a 000061 80. animals on premises with a his- total dose of 9 mg tory of swine dysentery, but fenbendazole/kg of body weight where symptoms have not yet within 3 to 12 days. Do not feed occurred; and for the removal to swine that weigh more than of: Adult stage lungworms 250 pounds. Lincomycin as pro- (Metastrongylus apri and M. vided by No. 054771; pudendotectus); adult and lar- fenbendazole as provided by vae (L3, 4 stages—liver, lung, No. 000061 in § 510.600(c) of intestinal forms) large this chapter. roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus).

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Lincomycin Combination in grams/ton grams/ton Indications for use Limitations Sponsors

(iii) 40...... Ivermectin, 1.8...... Weaned, growing and finishing Feed as the only feed for 7 con- 050604 swine: For control of swine dys- secutive days to provide 0.1 mg entery on premises with a his- ivermectin/kg of body weight tory of swine dysentery, but per day. A separate feed con- where symptoms have not yet taining 40 g/ton lincomycin may occurred; and for treatment and be continued to complete the control of gastrointestinal lincomycin treatment. Not to be roundworms (Ascaris suum, fed to swine that weigh more adults and fourth-stage larvae; than 250 lbs. Withdraw 5 days Ascarops strongylina, adults; before slaughter. Lincomycin as Hyostrongylus rubidus, adults provided by No. 054771; and fourth-stage larvae; ivermectin as provided by No. Oesophagostomum spp., adults 050604 in § 510.600(c) of this and fourth-stage larvae); kidney chapter. worms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis). (iv) 40 ...... Pyrantel, 96 ...... For control of swine dysentery on Feed as the sole ration. Not to be 066104 premises with a history of swine fed to swine that weigh more dysentery, but where symptoms than 250 pounds. Withdraw 6 have not yet occurred; as an days prior to slaughter. Linco- aid in the prevention of migra- mycin as provided by No. tion and establishment of large 054771; pyrantel as provided by roundworm (Ascaris suum) in- No. 066104 in § 510.600(c) of fections; and as an aid in the this chapter. prevention of establishment of nodular worm (Oesophagostomum spp.) infections. (v) 40 ...... Pyrantel, 96 ...... For the treatment and/or control of Feed for 3 days as the sole ration. 066104 swine dysentery; for removal Not to be fed to swine that and control of large roundworm weigh more than 250 pounds. (Ascaris suum) infections. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. (vi) 40 or 100 Pyrantel, 96 ...... For the treatment and/or control of For treatment of swine dysentery, 066104 swine dysentery; as an aid in feed 100 grams of lincomycin the prevention of migration and and 96 grams of pyrantel tar- establishment of large trate per ton of complete feed roundworm (Ascaris suum) infor 3 weeks or until clinical fections; and as an aid in the signs of the disease disappear, prevention of establishment of following with 40 grams of linco- nodular worm mycin and 96 grams of pyrantel (Oesophagostomum spp.) infec- tartrate per ton of complete feed tions. as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. (vii) 40 ...... Pyrantel, 800 ...... For the treatment and/or control of Feed as a single therapeutic treat- 066104 swine dysentery; for removal ment at a rate of 1 lb of feed and control of large roundworm per 40 lb of body weight for ani- (Ascaris suum) and nodular mals up to 200 lb and 5 lb of worm (Oesophagostomum spp.) feed per head for animals over infections. 200 lb. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. See paragraph (d) of this section. Linco- mycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter.

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Lincomycin Combination in grams/ton grams/ton Indications for use Limitations Sponsors

(viii) 100 ...... For treatment of swine dysentery Feed as the sole ration for 3 054771 and the control of porcine prolif- weeks or until clinical signs of erative enteropathies (ileitis) the disease disappear. caused by Lawsonia intracellularis. (ix) 100 ...... Fenbendazole, 10 to For the treatment of swine dys- Feed as sole ration to provide a 000061 80. entery; and for the removal of: total dose of 9 mg Adult stage lungworms fenbendazole/kg of body weight (Metastrongylus apri and M. within 3 to 12 days. Do not feed pudendotectus); adult and lar- to swine that weigh more than vae (L3, 4 stages—liver, lung, 250 pounds. Do not use within intestinal forms) large 6 days of slaughter. Lincomycin roundworms (Ascaris suum); as provided by No. 054771; adult stage nodular worms fenbendazole as provided by (Oesophagostomum dentatum, No. 000061 in § 510.600(c) of O. quadrispinulatum); adult this chapter. stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus). (x) 100...... Ivermectin, 1.8...... Weaned, growing and finishing Feed as the only feed for 7 con- 050604 swine: For the treatment of secutive days to provide 0.1 mg swine dysentery; and for treat- ivermectin/kg of body weight ment and control of gastro- per day. A separate feed con- intestinal roundworms (Ascaris taining 100 g/ton lincomycin suum, adults and fourth-stage may be continued to complete larvae; Ascarops strongylina, the lincomycin treatment. Not to adults; Hyostrongylus rubidus, be fed to swine that weigh more adults and fourth-stage larvae; than 250 lbs. Withdraw 6 days Oesophagostomum spp., adults before slaughter. Lincomycin as and fourth-stage larvae); provided by No. 054771; kidneyworms (Stephanurus ivermectin as provided by No. dentatus, adults and fourth- 050604 in § 510.600(c) of this stage larvae); lungworms chapter. (Metastrongylus spp., adults); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis). (xi) 100 ...... Pyrantel, 96 ...... For the treatment of swine dys- Feed as the sole ration for 3 066104 entery; as an aid in the preven- weeks or until clinical signs of tion of migration and establish- the disease disappear. Not to ment of large roundworm be fed to swine that weigh more (Ascaris suum) infections; and than 250 pounds. Withdraw 6 as an aid in the prevention of days prior to slaughter. Linco- establishment of nodular worm mycin as provided by No. (Oesophagostomum spp.) infec- 054771; pyrantel as provided by tions. No. 066104 in § 510.600(c) of this chapter. (xii) 100 ...... Pyrantel, 96 ...... For the treatment and/or control of Feed for 3 days as the sole ration. 066104 swine dysentery; for removal Not to be fed to swine that and control of large roundworm weigh more than 250 pounds. (Ascaris suum) infections. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. (xiii) 100 ...... Pyrantel, 800 ...... For the treatment and/or control of Feed as a single therapeutic treat- 066104 swine dysentery; for removal ment. Not to be fed to swine and control of large roundworm that weigh more than 250 (Ascaris suum) and nodular pounds. Withdraw 24 hours worm (Oesophagostomum spp.) prior to slaughter. Lincomycin infections. as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. (xiv) 200 ...... For reduction in the severity of Feed as sole ration for 21 days .... 054771 swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae.

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Lincomycin Combination in grams/ton grams/ton Indications for use Limitations Sponsors

(xv) 200 ...... Fenbendazole, 10 to For reduction in the severity of Feed as sole ration to provide a 000061 80. swine mycoplasmal pneumonia total dose of 9 mg caused by Mycoplasma fenbendazole/kg of body weight hyopneumoniae; and for the re- within 3 to 12 days. Do not feed moval of: Adult stage to swine that weigh more than lungworms (Metastrongylus apri 250 pounds. Do not use within and M. pudendotectus); adult 6 days of slaughter. Lincomycin and larvae (L3, 4 stages—liver, as provided by No. 054771; lung, intestinal forms) large fenbendazole as provided by roundworms (Ascaris suum); No. 000061 in § 510.600(c) of adult stage nodular worms this chapter. (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus). (xvi) 200 ...... Ivermectin, 1.8...... For reduction in the severity of Feed as the only feed for 7 con- 050604 swine mycoplasmal pneumonia secutive days to provide 0.1 mg caused by Mycoplasma ivermectin/kg of body weight hyopneumoniae; and for treat- per day. A separate feed con- ment and control of gastro- taining 200 g/ton lincomycin intestinal roundworms (Ascaris may be continued for an addi- suum, adults and fourth-stage tional 14 days to complete the larvae; Ascarops strongylina, lincomycin treatment. Not to be adults; Hyostrongylus rubidus, fed to swine that weigh more adults and fourth-stage larvae; than 250 lbs. Withdraw 6 days Oesophagostomum spp., adults before slaughter. Lincomycin as and fourth-stage larvae); provided by No. 054771; kidneyworms (Stephanurus ivermectin as provided by No. dentatus, adults and fourth- 050604 in § 510.600(c) of this stage larvae); lungworms chapter. (Metastrongylus spp., adults); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis). (xvii) 200...... Pyrantel, 96 ...... For reduction in the severity of Feed as the sole ration for 21 054771 swine mycoplasmal pneumonia days. Not for use in swine that caused by Mycoplasma weigh more than 250 pounds. hyopneumoniae; and as an aid Withdraw 6 days before slaugh- in the prevention of migration ter. Lincomycin as provided by and establishment of large No. 054771; pyrantel as pro- roundworm (Ascaris suum) in- vided by No. 066104 in fections; aid in the prevention of § 510.600(c) of this chapter. establishment of nodular worm (Oesophagostomum spp.) infections.

[81 FR 95005, Dec. 27, 2016, as amended at 82 FR 12170, Mar. 1, 2017; 82 FR 21691, May 10, 2017; 83 FR 13637, Mar. 30, 2018]

§ 558.340 Maduramicin. E. brunetti, E. maxima, E. necatrix, and E. mivati. (a) Approvals. Type A medicated articles: 4.54 grams per pound to 054771 in (3) Limitations. For broiler chickens § 510.600(c) of this chapter. only. Feed continuously as sole ration. (b) Tolerances. See § 556.375 of this chapter. (c) Conditions of use—(1) Amount. 4.54 to 5.45 grams per ton (5 to 6 parts per million) (1 to 1.2 pounds per ton). (2) Indications for use. Broiler chickens: For prevention of coccidiosis caused by Eimeria acervulina, E. tenella,

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Do not feed to laying hens. Withdraw 5 (ii) For liquid feeds stored in me- days before slaughter. chanical, air, or other agitation type tank systems: Agitate immediately [54 FR 5229, Feb. 2, 1989, as amended at 54 FR 26732, June 26, 1989; 54 FR 32635, Aug. 9, 1989; prior to use for not less than 10 min- 54 FR 33885, Aug. 17, 1989; 55 FR 23, Jan. 2, utes, creating a turbulence at the bot- 1990; 55 FR 8460, Mar. 8, 1990; 55 FR 49616, tom of the tank that is visible at the Nov. 30, 1990; 59 FR 8134, Feb. 18, 1994; 61 FR top. Agitate daily as described even 18082, Apr. 24, 1996; 63 FR 27845, May 21, 1998; when not used. 66 FR 46706, Sept. 7, 2001; 79 FR 13545, Mar. 11, (2) A physically stable melengestrol 2014; 81 FR 22525, Apr. 18, 2016] acetate liquid Type B or C feed will not be subject to the requirements for mix- § 558.342 Melengestrol. ing directions prescribed in paragraph (a) Specifications. (1) Dry Type A (d)(1) of this section provided it has a medicated articles containing 100 or 200 pH of 4.0 to 8.0 and contains a sus- milligrams (mg) melengestrol acetate pending agent(s) sufficient to maintain per pound. a viscosity of not less than 300 centi- (2) Liquid Type A medicated article poises per second for 3 months. containing 500 mg melengestrol acetate (3) Combination Type B or C medi- per pound. cated feeds containing lasalocid must (b) Approvals. See sponsors in be labeled in accordance with § 510.600(c) of this chapter for use as in § 558.311(d)(5) of this chapter. paragraph (e) of this section. (4) Liquid combination Type B or C (1) No. 054771 for use of products de- medicated feeds containing scribed in paragraph (a) of this section. melengestrol acetate and lasalocid (2) No. 058198 for use of product de- must be manufactured in accordance scribed in paragraph (a)(2) of this sec- with § 558.311(d) of this chapter. tion. (5) Combination Type B or C medi- (c) Related tolerances. See § 556.380 of cated feeds containing monensin must this chapter. be labeled in accordance with (d) Special considerations. (1) Type B § 558.355(d) of this chapter. or C medicated feeds may be manufac- (6) Liquid combination Type B or C tured from melengestrol acetate liquid medicated feeds containing Type A articles or Type B or C medi- melengestrol acetate and monensin cated feeds which have a pH of 4.0 to 8.0 must be manufactured in accordance and bear appropriate mixing directions with § 558.355(f)(3)(i) of this chapter. as follows: (7) Liquid combination Type B or C (i) For liquid feeds stored in recircu- medicated feeds containing lating tank systems: Recirculate im- melengestrol acetate and tylosin must mediately prior to use for no less than be manufactured in accordance with 10 minutes, moving not less than 1 per- § 558.625(c) of this chapter. cent of the tank contents per minute (8) Liquid melengestrol acetate may from the bottom of the tank to the top. not be mixed with oxytetracycline in a Recirculate daily as described even common liquid feed supplement. when not used. (e) Conditions of use—(1) Cattle.

Melengestrol acetate in mg/head/ Combination in mg/ Indications for use Limitations Sponsor day head/day

(i) 0.25 to 0.5 ...... Heifers fed in confinement for slaugh- Administer 0.5 to 2.0 pounds 054771, ter: For increased rate of weight (lb)/head/day of medicated 058198 gain, improved feed efficiency, and feed containing 0.125 to 1.0 suppression of estrus (heat).. mg melengestrol acetate/lb to provide 0.25 to 0.5 mg melengestrol acetate/head/ day.. (ii) 0.5...... Heifers intended for breeding: For Administer 0.5 to 2.0 lb/head/ 054771, suppression of estrus (heat).. day of Type C feed con- 058198 taining 0.25 to 1.0 mg melengestrol acetate/lb to provide 0.5 mg melengestrol acetate/head/day. Do not exceed 24 days of feeding..

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Melengestrol acetate in mg/head/ Combination in mg/ Indications for use Limitations Sponsor day head/day

(iii)–(ix) [Re- served]. (x) 0.25 to 0.5 ..... Monensin 50 to 480. Heifers fed in confinement for slaugh- Add at the rate of 0.5 to 2.0 lb/ 054771 ter: As in paragraph (e)(1)(i) of this head/day a medicated feed 058198 section; and for the prevention and (liquid or dry) containing control of coccidiosis due to 0.125 to 1.0 mg melengestrol Eimeria bovis and E. zuernii.. acetate/lb to a feed containing 10 to 40 g of monensin per ton to provide 0.25 to 0.5 mg melengestrol acetate/head/day and 0.14 to 0.42 mg monensin/lb body weight, depending on severity of coccidiosis challenge, up to 480 mg monensin/ head/day...... Monensin provided by No. 058198 in § 510.600(c) of this chapter.. (xi) [Reserved].

(2) Melengestrol may also be used in intended for animals being used pri- combination with: marily for breeding purposes. Use oral- (i) Ractopamine as in § 558.500. ly in adult female dogs only. Federal (ii) Tylosin as in § 558.625. law restricts this drug to use by or on (iii) Zilpaterol as in § 558.665. the order of a licensed veterinarian. [42 FR 28535, June 3, 1977] [47 FR 6617, Feb. 16, 1982, as amended at 79 FR 13545, Mar. 11, 2014] EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 558.342, see the List of CFR Sections Affected, which appears in the § 558.355 Monensin. Finding Aids section of the printed volume (a) Specifications. Type A medicated and at www.fdsys.gov. articles containing 45, 60, 90.7, or 110 grams monensin, USP, per pound. § 558.348 Mibolerone. (b) Approvals. See sponsor numbers in (a) Approvals. To No. 054771in § 510.600(c) of this chapter for condi- § 510.600(c) of this chapter for a canned tions of use as in paragraph (f) of this dog food, each 61⁄2 ounce can containing section: 30 or 60 micrograms of mibolerone. (1) No. 058198 for use as in paragraph (b) Conditions of use—(1) Amount. 30 (f) of this section. micrograms for animals weighing up to (2) No. 054771 for use as in paragraphs 25 pounds; 60 micrograms for animals (f)(1)(xxiv) and (xxv) of this section. weighing 26 to 50 pounds; 120 (3) No. 058198 for use as in paragraphs micrograms for animals weighing 51 to (f)(1)(i), (iii), (iv), and (v) of this sec- 100 pounds; 180 micrograms for animals tion. weighing over 100 pounds, or German (c) [Reserved] Shepherds or German Shepherd mix (d) Special considerations. (1) Type C weighing 30 to 80 pounds. chicken feed containing monensin as (2) Indications for use. For the preven- the mycelial cake shall bear an expiration of estrus (heat) in adult female tion date of 90 days after its date of dogs not intended primarily for breed- manufacture. ing purposes. (2)–(3) [Reserved] (3) Limitations. Administer daily at (4) Liquid Type B feeds shall bear an least 30 days before expected initiation expiration date of 8 weeks after its of heat and continue as long as desired, date of manufacture. but for not more than 12 months. (5) All Type A medicated articles Mibolerone should not be used in containing monensin shall bear the fol- bitches before first estrous period or in lowing warning statement: When mix- purebred Bedlington terriers. It is not ing and handling monensin Type A

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medicated articles, use protective fed. Increased incidence of cystic ova- clothing, impervious gloves, and a dust ries and metritis in dairy cows fed mask. Operators should wash thor- monensin. Reduced conception rates, oughly with soap and water after han- increased services per animal, and ex- dling. If accidental eye contact occurs, tended days open and corresponding immediately rinse thoroughly with calving intervals in dairy cows fed water. monensin. Have a comprehensive and (6) All formulations containing ongoing nutritional, reproductive, and monensin shall bear the following cau- herd health program in place when tion statement: Do not allow horses or feeding monensin to dairy cows. other equines access to feed containing (x) Inadequate mixing (recirculation monensin. Ingestion of monensin by or agitation) of monensin liquid Type B horses has been fatal. or Type C medicated feeds has resulted (7) Type A medicated articles con- in increased monensin concentration taining monensin intended for use in which has been fatal to cattle and cattle and goats shall bear, in addition could be fatal to goats. to the caution statement in paragraph (8) Type A medicated articles con- (d)(6) of this section, the following taining monensin intended for use in statements: chickens, turkeys, and quail shall bear (i) Monensin medicated cattle and the following statements: goat feeds are safe for use in cattle and goats only. Consumption by unap- (i) Do not allow horses, other proved species may result in toxic re- equines, mature turkeys, or guinea actions. fowl access to feed containing (ii) Feeding undiluted or mixing er- monensin. Ingestion of monensin by rors resulting in high concentrations of horses and guinea fowl has been fatal. monensin has been fatal to cattle and (ii) Must be thoroughly mixed in could be fatal to goats. feeds before use. (iii) Must be thoroughly mixed in (iii) Do not feed undiluted. feeds before use. (iv) Do not feed to laying chickens. (iv) Do not feed undiluted. (v) Do not feed to chickens over 16 (v) Do not exceed the levels of weeks of age. monensin recommended in the feeding (vi) For replacement chickens in- directions, as reduced average daily tended for use as cage layers only. gains may result. (vii) Some strains of turkey coccidia (vi) Do not feed to lactating goats. may be monensin tolerant or resistant. (vii) If feed refusals containing Monensin may interfere with develop- monensin are fed to other groups of ment of immunity to turkey coccidi- cattle, the concentration of monensin osis. in the refusals and amount of refusals (viii) In the absence of coccidiosis in fed should be taken into consideration broiler chickens the use of monensin to prevent monensin overdosing (see with no withdrawal period may limit paragraphs (d)(10)(i) and (d)(10)(ii) of this section). feed intake resulting in reduced weight (viii) A withdrawal period has not gain. been established for this product in (9) Type B feeds containing monensin pre-ruminating calves. Do not use in shall bear the statements specified in calves to be processed for veal. the following paragraphs of this sec- (ix) You may notice the following: tion when intended for use in: Reduced voluntary feed intake in dairy (i) Cattle (as described in paragraphs cows fed monensin. This reduction in- (f)(3)(i) through (f)(3)(xii) of this section): creases with higher doses of monensin See paragraphs (d)(6), (d)(7)(i) through fed. Rule out monensin as the cause of (d)(7)(v), (d)(7)(vii), and (d)(7)(viii) of reduced feed intake before attributing this section. to other causes such as illness, feed (ii) Dairy cows (as described in para- management, or the environment. Re- graphs (f)(3)(xiii) and (f)(3)(xiv) of this duced milk fat percentage in dairy section): See paragraphs (d)(6), (d)(7)(i) cows fed monensin. This reduction in- through (d)(7)(iv), (d)(7)(vii), (d)(7)(viii), creases with higher doses of monensin and (d)(7)(ix) of this section.

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(iii) Goats: See paragraphs (d)(6) and (ii) For liquid feeds stored in me- (d)(7)(i) through (d)(7)(vi) of this sec- chanical, air, or other agitation-type tion. tank systems: Agitate immediately (iv) Chickens: See paragraphs (d)(8)(i) prior to use for not less than 10 min- through (d)(8)(vi), and (d)(8)(viii) of this utes, creating a turbulence at the bot- section. tom of the tank that is visible at the (v) Turkeys: See paragraphs (d)(8)(i), top. Agitate daily as described even (d)(8)(ii), (d)(8)(iii), and (d)(8)(vii) of when not used. this section. (e) Related tolerances. See § 556.420 of (vi) Quail: See paragraphs (d)(8)(i), this chapter. (d)(8)(ii), and (d)(8)(iii) of this section. (f) Conditions of use. It is used as fol- (10) Type C feeds containing lows: monensin shall bear the statements (1) Broiler chickens—(i) Amount per specified in the following paragraphs of ton. Monensin, 90–110 grams. this section when intended for use in: (a) Indications for use. As an aid in (i) Cattle (as described in paragraphs the prevention of coccidiosis caused by (f)(3)(i) through (f)(3)(xii) of this section): E. necatrix, E. tenella, E. acervulina, E. See paragraphs (d)(6), (d)(7)(i), (d)(7)(v), brunetti, E. mivati, and E. maxima. (d)(7)(vii), and (d)(7)(viii) of this sec- (b) Limitations. Feed continuously as tion. Paragraph (d)(7)(vii) of this sec- the sole ration. In the absence of coc- tion does not apply to free-choice Type cidiosis, the use of monensin with no C medicated feeds as defined in § 510.455 withdrawal period may limit feed in- of this chapter. take resulting in reduced weight gain. Do not feed to laying chickens. (ii) Dairy cows (as described in para- (ii) [Reserved] graphs (f)(3)(xiii) and (f)(3)(xiv) of this (iii) Amount per ton. Monensin, 90–110 section): See paragraphs (d)(6), (d)(7)(i), grams plus bacitracin, 5–25 grams. (d)(7)(vii), (d)(7)(viii), and (d)(7)(ix) of (a) Indications for use. For increased this section. Paragraph (d)(7)(vii) of rate of weight gain and improved feed this section does not apply to free- efficiency; as an aid in the prevention choice Type C medicated feeds as de- of coccidiosis caused by E. necatrix, E. fined in § 510.455 of this chapter. tenella, E. acervulina, E. brunetti, E. (iii) Goats: See paragraphs (d)(6), mivati, and E. maxima. (d)(7)(i), (d)(7)(v), and (d)(7)(vi) of this (b) Limitations. Do not feed to laying section. chickens; feed continuously as sole ra- (iv) Chickens: See paragraphs (d)(8)(i), tion; in the absence of coccidiosis, the (d)(8)(iv), (d)(8)(v), (d)(8)(vi), and use of monensin with no withdrawal (d)(8)(viii) of this section. period may limit feed intake resulting (v) Turkeys: See paragraphs (d)(8)(i) in reduced weight gain; as bacitracin and (d)(8)(vii) of this section. methylenedisalicylate provided by No. (vi) Quail: See paragraph (d)(8)(i) of 054771 in § 510.600(c) of this chapter; as this section. monensin sodium. (11) Type B and Type C liquid feeds (iv) Amount per ton. Monensin, 90–110 requiring recirculation or agitation grams plus bacitracin, 10 grams. that contain monensin and are in- (a) Indications for use. For increased tended for use in cattle (including rate of weight gain and improved feed dairy cows) and goats shall bear the efficiency; as an aid in the prevention caution statement specified in para- of coccidiosis caused by E. necatrix, E. graph (d)(7)(x) of this section. tenella, E. acervulina, E. brunetti, E. (12) Mixing directions for liquid feeds mivati, and E. maxima. requiring recirculation or agitation: (b) Limitations. Do not feed to laying (i) For liquid feeds stored in recircu- chickens; feed continuously as sole ra- lating tank systems: Recirculate im- tion; in the absence of coccidiosis, the mediately prior to use for not less than use of monensin with no withdrawal 10 minutes, moving not less than 1 per- period may limit feed intake resulting cent of the tank contents per minute in reduced weight gain; as zinc baci- from the bottom of the tank to the top. tracin provided by No. 054771 in Recirculate daily as described even § 510.600(c) of this chapter; as monensin when not used. sodium.

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(v) Amount per ton. Monensin, 90–110 period may limit feed intake resulting grams plus bacitracin, 10–30 grams. in reduced weight gain; as bacitracin (a) Indications for use. For improved zinc provided by No. 054771 in feed efficiency; as an aid in the preven- § 510.600(c) of this chapter, as monensin tion of coccidiosis caused by E. sodium. necatrix, E. tenella, E. acervulina, E. (xxvi)–(xxviii) [Reserved] brunetti, E. mivati, and E. maxima. (xxix) Amount per ton. Monensin, 90 to (b) Limitations. Do not feed to laying 110 grams; plus bacitracin chickens; feed continuously as sole ra- methylenedisalicylate, 50 grams. tion; in the absence of coccidiosis, the (a) Indications for use. As an aid in use of monensin with no withdrawal the prevention of coccidiosis caused by period may limit feed intake resulting E. necatrix, E. tenella, E. acervulina, E. in reduced weight gain; as zinc baci- brunetti, E. mivati, and E. maxima; and tracin provided by No. 054771 in as an aid in the prevention of necrotic § 510.600(c) of this chapter; as monensin enteritis caused or complicated by sodium. Clostridium spp. or other organisms sus- (vi) Amount per ton. Monensin, 90 to ceptible to bacitracin. 110 grams; plus bambermycins, 1 to 2 (b) Limitations. Feed continuously as grams. sole ration. Do not feed to chickens (a) Indications for use. For increased over 16 weeks of age. Do not feed to rate of weight gain and improved feed laying chickens. As monensin sodium efficiency; and as an aid in the preven- provided by 058198; bacitracin tion of coccidiosis caused by E. methylenedisalicylate as provided by necatrix, E. tenella,E. acervulina, E. 054771 in § 510.600(c) of this chapter. brunetti, E. mivati, and E. maxima. (xxx)–(xxxi) [Reserved] (b) Limitations. Feed continuously as (2) Turkeys—(i) Amount per ton. sole ration; do not feed to laying chick- Monensin, 54 to 90 grams. ens. Bambermycins provided by No. (a) Indications for use. For the preven- 016592 in § 510.600(c) of this chapter. tion of coccidiosis in turkeys caused by (vii)–(xxiii) [Reserved] E. adenoeides, E. meleagrimitis, and E. (xxiv) Amount per ton. Monensin, 90 to gallopavonis. 110 grams, plus bacitracin (b) Limitations. For growing turkeys methylenedisalicylate, 4 to 50 grams. only; as monensin sodium; feed con- (a) Indications for use. For improved tinuously as sole ration. Do not allow feed efficiency; as an aid in the preven- horses, other equines, mature turkeys, tion of coccidiosis caused by Eimeria or guinea fowl access to feed con- necatrix, E. tenella, E. acervulina, E. taining monensin. Ingestion of maxima, E. brunetti, and E. mivati. monensin by horses and guinea fowl (b) Limitations. Do not feed to laying has been fatal. Some strains of turkey chickens; feed continuously as sole ra- coccidia may be monensin tolerant or tion; in the absence of coccidiosis, the resistant. Monensin may interfere with use of monensin with no withdrawal development of immunity to turkey period may limit feed intake resulting coccidiosis. in reduced weight gain; as bacitracin (ii) Amount per ton. Monensin, 54 to 90 methylenedisalicylate provided by No. grams, and bacitracin 054771 in § 510.600(c) of this chapter. methylenedisalicylate, 4 to 50 grams. (xxv) Amount per ton. Monensin, 90 to (a) Indications for use. For prevention 110 grams, plus bacitracin zinc, 4 to 50 of coccidiosis caused by Eimeria grams. adenoeides, E. meleagrimitis, and E. (a) Indications for use. For increased gallopavonis, for increased rate of rate of weight gain and improved feed weight gain, and for improved feed effi- efficiency; as an aid in the prevention ciency. of coccidiosis caused by Eimeria (b) Limitations. For growing turkeys necatrix, E. tenella, E. acervulina, E. only; as monensin sodium; feed con- brunetti, E. mivati, and E. maxima. tinuously as sole ration. Do not allow (b) Limitations. Do not feed to laying horses, other equines, mature turkeys chickens; feed continuously as sole ra- or guinea fowl access to feed con- tion; in the absence of coccidiosis, the taining monensin. Ingestion of use of monensin with no withdrawal monensin by horses and guinea fowl

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has been fatal. Some strains of turkey monensin tolerant or resistant. coccidia may be monensin tolerant or Monensin may interfere with develop- resistant. Monensin may interfere with ment of immunity to turkey coccidi- development of immunity to turkey osis. Bambermycins as provided by No. coccidiosis. Bacitracin 016592 in § 510.600(c) of this chapter. methylenedisalicylate as provided by (3) Cattle—(i) Amount per ton. No. 054771 in § 510.600(c) of this chapter. Monensin, 5–40 grams. (iii) Amount per ton. Monensin, 54 to (a) Indications for use. Improved feed 90 grams, and bacitracin efficiency. methylenedisalicylate, 200 grams. (b) Limitations. (1) Feed only to cattle (a) Indications for use. For the preven- being fed in confinement for slaughter. tion of coccidiosis caused by Eimeria Feed continuously in complete feed at adenoides, E. meleagrimitis, and E. a rate of 50 to 480 milligrams of gallopavonis, and as an aid in the con- monensin per head per day. No addi- trol of transmissible enteritis com- tional improvement in feed efficiency plicated by organisms susceptible to has been shown from feeding monensin bacitracin methylenedisalicylate. at levels greater than 30 grams per ton (b) Limitations. For growing turkeys (360 milligrams per head per day). Com- only; as monensin sodium; feed con- plete feeds may be manufactured from tinuously as sole ration. Do not allow monensin liquid Type B feeds. The liq- horses, other equines, mature turkeys uid Type B feeds have a pH of 4.3 to 7.1 or guinea fowl access to feed con- and their labels must bear appropriate taining monensin. Ingestion of mixing directions as defined in para- monensin by horses and guinea fowl graph (d)(12) of this section. The liquid has been fatal. Some strains of turkey feed must bear caution statement as coccidia may be monensin tolerant or follows: Inadequate mixing, (recircula- resistant. Monensin may interfere with tion or agitation), of liquid feeds has development of immunity to turkey resulted in increased monensin con- coccidiosis. Bacitracin centration which has been fatal to cat- methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. tle. (iv) [Reserved] (2) An approved physically stable (v) Amount per ton. Monensin, 54 to 90 monensin liquid feed will not be sub- grams, plus bambermycins, 1 to 2 ject to the requirements for mixing di- grams. rections defined in paragraph (d)(12) of (a) Indications for use. For the preven- this section. A manufacturer may se- tion of coccidiosis in turkeys caused by cure approval of a physically stable liq- E. adenoeides, E. meleagrimitis, and E. uid feed by: gallopavonis, and for improved feed effi- (i) Either filing an NADA for the ciency in growing turkeys. product or by establishing a master file (b) Limitations. For growing turkeys containing data to support the sta- only. Feed continuously as sole ration. bility of its product; Some strains of turkey coccidia may be (ii) Authorizing the agency to ref- monensin tolerant or resistant. erence and rely upon the data in the Monensin may interfere with develop- master file to support approval of a ment of immunity to turkey coccidi- supplemental NADA to establish phys- osis. Bambermycins as provided by No. ical stability; and 016592 in § 510.600(c) of this chapter. (iii) Requesting No. 058198 in (vi) Amount per ton. Monensin, 54 to § 510.600(c) of this chapter to file a sup- 90 grams, plus bambermycins, 2 grams. plemental NADA to provide for the use (a) Indications for use. For the preven- of its monensin Type A article in the tion of coccidiosis in turkeys caused by manufacture of the liquid feed specified E. adenoeides, E. meleagrimitis, and E. in the appropriate master file. If the gallopavonis, and for increased rate of data demonstrate the stability of the weight gain and improved feed effi- liquid feed described in the master file, ciency in growing turkeys. the agency will approve the supple- (b) Limitations. For growing turkeys mental NADA. The approval will pro- only. Feed continuously as sole ration. vide a basis for the individual liquid Some strains of turkey coccidia may be feed manufacturer to manufacture the

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liquid medicated feed under a medi- pasture and to unmedicated supple- cated feed mill license described in the ment before using the monensin medi- master file. A manufacturer who seeks cated supplement. The product’s effec- to market a physically unstable tiveness in cull cows and bulls has not monensin liquid feed with mixing di- been established. See paragraph (d) of rections different from the standard es- this section for other required label tablished in paragraph (d)(12) of this warnings. section may also follow this procedure. (v) [Reserved] (ii) [Reserved] (vi) Amount per ton. Monensin, 25 to (iii) Amount per ton. Monensin, 15 to 400 grams. 400 grams. (a) Indications for use. For improved (a) Indications for use. Growing cattle feed efficiency; for prevention and con- on pasture or in dry lot (stocker and trol of coccidiosis due to E. bovis and E. feeder cattle and dairy and beef re- zuernii. placement heifers): For increased rate (b) Limitations. Feed to mature repro- of weight gain; for prevention and con- ducing beef cows. Feed as supplemental trol of coccidiosis due to Eimeria bovis feed, either hand-fed in a minimum of and E. zuernii. 1 pound of feed or mixed in a total ra- (b) Limitations. For increased rate of tion. For improved feed efficiency, feed weight gain, feed at a rate of 50 to 200 continuously at a rate of 50 to 200 mil- milligrams monensin per head per day ligrams monensin per head per day. in not less than 1 pound of feed or, For prevention and control of coccidi- after the 5th day, feed at a rate of 400 osis, feed at a rate of 0.14 to 0.42 milli- milligrams per head per day every gram per pound of body weight per day, other day in not less than 2 pounds of depending upon severity of challenge, feed. For prevention and control of coc- up to a maximum of 200 milligrams per cidiosis, feed at a rate of 0.14 to 0.42 head per day. During first 5 days of milligram per pound of body weight per feeding, cattle should receive no more day, depending on severity of chal- than 100 milligrams per head per day. lenge, up to 200 milligrams per head per day. During first 5 days of feeding, cat- (vii) Amount per ton. Monensin, 10 to tle should receive no more than 100 40 grams. milligrams per day in not less than 1 (a) Indications for use. For prevention pound of feed. and control of coccidiosis due to E. (iv) Amount. Monensin at concentra- bovis and E. zuernii. tions in free-choice Type C medicated (b) Limitations. For cattle fed in con- feeds to provide 50 to 200 mg per head finement for slaughter, feed at a rate of per day. 0.14 to 0.42 milligram per pound of body (a) Indications for use. Growing cattle weight per day, depending upon the se- on pasture or in dry lot (stocker and verity of challenge, up to maximum of feeder cattle and dairy and beef re- 480 milligrams per head per day. placement heifers): For increased rate (viii)–(ix) [Reserved] of weight gain; for prevention and con- (x) Amount per ton. 1,620 grams trol of coccidiosis due to Eimeria bovis monensin, USP. and E. zuernii. (a) Indications for use. Growing cattle (b) Limitations. During the first 5 days on pasture or in dry lot (stocker and of feeding, cattle should receive no feeder cattle and dairy and beef re- more than 100 milligrams per day. Do placement heifers): For increased rate not feed additional salt or minerals. Do of weight gain; for prevention and con- not mix with grain or other feeds. trol of coccidiosis due to Eimeria bovis Monensin is toxic to cattle when con- and E. zuernii. sumed at higher than approved levels. (b) Specifications. Use as free-choice Stressed and/or feed- and/or water-de- Type C medicated feed formulated as prived cattle should be adapted to the mineral granules as follows:

International feed Ingredient Percent No.

Monocalcium phosphate (21% phosphorus, 15% calcium) ...... 29.49 6–01–082 Sodium chloride (salt) ...... 24 .37 6–04–152 Dried cane molasses ...... 20 .0 4–04–695

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International feed Ingredient Percent No.

Ground limestone (33% calcium) or calcium carbonate (38% calcium) ...... 13 .75 6–02–632 Cane molasses ...... 3 .0 4–04–696 Processed grain by-products (as approved by AAFCO) ...... 5.0 Vitamin/trace mineral premix 1 ...... 2 .5 Monensin Type A article, 90.7 grams per pound ...... 0.89 Antidusting oil ...... 1 .0 1 Content of the vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free- choice feeds. Formulation modifications require FDA approval prior to marketing. The amount of selenium and ethylenediamine dihydroiodide (EDDI) must comply with the published requirements. (For selenium see 21 CFR 573.920; for EDDI see 51 FR 11483 (April 3, 1986).)

(c) Limitations. Feed at a rate of 50 to ponent feeding system (including top 200 milligrams per head per day. Dur- dress). The Type C medicated feed must ing the first 5 days of feeding, cattle be fed in a minimum of 1 lb of feed to should receive no more than 100 milli- provide 185 to 660 mg/head/day grams per day. Do not feed additional monensin to lactating cows or 115 to salt or minerals. Do not mix with grain 410 mg/head/day monensin to dry cows. or other feeds. Monensin is toxic to See special labeling considerations in cattle when consumed at higher than paragraph (d) of this section. approved levels. Stressed and/or feed- (4) Replacement chickens intended for and/or water-deprived cattle should be use as cage layers—(i) Amount per ton. adapted to the pasture and to Monensin, 90 to 110 grams. unmedicated mineral supplement be- (i)(a) Indications for use. As an aid in fore using the monensin mineral sup- the prevention of coccidiosis caused by plement. The product’s effectiveness in E. necatrix, E. tenella, E. acervulina, E. cull cows and bulls has not been estab- brunetti, E. mivati, and E. maxima. lished. (ii) Amount per ton. Monensin, 90 to (xi) Amount per ton. Monensin, 10 to 110 grams; plus bacitracin 200 grams. methylenedisalicylate, 4 to 50 grams. (a) Indications for use. For prevention (a) Indications for use. As an aid in and control of coccidiosis due to E. the prevention of coccidiosis caused by bovis and E. zuernii. E. necatrix, E. tenella, E. acervulina, E. (b) Limitations. For calves excluding brunetti, E. mivati, and E. maxima; for veal calves. Feed at a rate of 0.14 to 1.0 increased rate of weight gain, and im- milligram monensin per pound of body proved feed efficiency. weight per day, depending upon the se- (b) Limitations. Feed continuously as verity of challenge, up to maximum of sole ration. Do not feed to chickens 200 milligrams per head per day. over 16 weeks of age. Do not feed to (xii) [Reserved] laying chickens. As monensin sodium (xiii) Amount per ton. Monensin, 11 to provided by 058198; bacitracin 22 grams. methylenedisalicylate as provided by (A) Indications for use. For increased 054771 in § 510.600(c) of this chapter. milk production efficiency (production (iii) Amount per ton. Monensin, 90 to of marketable solids-corrected milk 110 grams; plus bacitracin per unit of feed intake) in dairy cows. methylenedisalicylate, 50 grams. (B) Limitations. Feed continuously to (a) Indications for use. As an aid in dry and lactating dairy cows in a total the prevention of coccidiosis caused by mixed ration (‘‘complete feed’’). See E. necatrix, E. tenella, E. acervulina, E. special labeling considerations in para- brunetti, E. mivati, and E. maxima; and graph (d) of this section. as an aid in the prevention of necrotic (xiv) Amount per ton. Monensin, 11 to enteritis caused or complicated by 400 grams. Clostridium spp. or other organisms sus- (A) Indications for use. For increased ceptible to bacitracin. milk production efficiency (production (b) Limitations. Feed continuously as of marketable solids-corrected milk sole ration. Do not feed to chickens per unit of feed intake) in dairy cows. over 16 weeks of age. Do not feed to (B) Limitations. Feed continuously to laying chickens. As monensin sodium dry and lactating dairy cows in a com- provided by 058198; bacitracin

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methylenedisalicylate as provided by liquid medicated feed under a medi- 054771 in § 510.600(c) of this chapter. cated feed mill license described in the (iv)–(vii) [Reserved] master file. A manufacturer who seeks (5) Bobwhite quail—(i) Amount per ton. to market a physically unstable Monensin, 73 grams. monensin liquid feed with mixing di- (ii) Indications for use. For the pre- rections different from the standard es- vention of coccidiosis in growing bob- tablished in paragraph (d)(12) of this white quail caused by Eimeria dispersa section may also follow this procedure. and E. Lettyae. (ii) [Reserved] (iii) Limitations. Feed continuously as (7) Free-choice feeds—(i) Amount. 150 the sole ration; do not allow horses, milligrams per pound of protein-min- other equines, mature turkeys, or guin- eral block (0.033 percent). ea fowl access to feed containing (a) [Reserved] monensin. (b) Conditions of use—(1) Indications (6) Goats—(i) Amount per ton. for use. For increased rate of weight Monensin, 20 grams. gain; and for prevention and control of (a) Indications for use. For the preven- coccidiosis caused by Eimeria bovis and tion of coccidiosis caused by Eimeria E. zuernii in pasture cattle (slaughter, crandallis, E. christenseni, and E. stocker, feeder, and dairy and beef re- ninakohlyakimovae. placement heifers) which may require (b) Limitations—(1) Feed continuously. supplemental feed. Feed only to goats being fed in confine- (2) Limitations. Provide 50 to 200 milli- ment. Do not feed to lactating goats. grams of monensin (0.34 to 1.33 pounds Type C feeds may be manufactured of block) per head per day, at least 1 from monensin liquid Type B feeds. block per 10 to 12 head of cattle. The liquid Type B feeds have a pH of 4.3 Roughage must be available at all to 7.1 and their labels must bear appro- times. Do not allow animals access to priate mixing directions, as defined in other protein blocks, salt or mineral, paragraph (d)(12) of this section. See while being fed this product. The effec- special labeling considerations in para- tiveness of this block in cull cows and graph (d) of this section. bulls has not been established. See ( ) An approved physically stable 2 paragraph (d)(10)(i) of this section. monensin liquid feed will not be sub- (ii) Amount. 400 milligrams per pound ject to the requirements for mixing di- of protein-mineral block (0.088 per- rections defined in paragraph (d)12) of cent). this section. A manufacturer may secure approval of a physically stable liq- (a) Sponsor. See No. 067949 in uid feed by: § 510.600(c) of this chapter. (i) Either filing an NADA for the (b) Conditions of use—(1) Indications product or by establishing a master file for use. For increased rate of weight containing data to support the sta- gain in pasture cattle (slaughter, bility of its product; stocker, feeder, and dairy and beef re- (ii) Authorizing the agency to ref- placement heifers). erence and rely upon the data in the (2) Limitations. Provide 80 to 200 milli- master file to support approval of a grams of monensin (0.2 to 0.5 pounds of supplemental NADA to establish phys- block) per head per day, at least 1 ical stability; and block per 5 head of cattle. Feed blocks (iii) Requesting No. 058198 in continuously. Do not feed salt or min- § 510.600(c) of this chapter to file a sup- erals containing salt. The effectiveness plemental NADA to provide for the use of this block in cull cows and bulls has of its monensin Type A article in the not been established. See paragraph manufacture of the liquid feed specified (d)(10)(i) of this section. in the appropriate master file. If the (iii) Amount. 175 milligrams per data demonstrate the stability of the pound of protein-mineral block (0.038 liquid feed described in the master file, percent). the agency will approve the supple- (a) Sponsor. See No. 017800 in mental NADA. The approval will pro- § 510.600(c) of this chapter. vide a basis for the individual liquid (b) Conditions of use—(1) Indications feed manufacturer to manufacture the for use. For increased rate of weight

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gain in pasture cattle (slaughter, corporated because those paragraphs did not stocker, and feeder). exist. (2) Limitations. Provide 40 to 200 milligrams of monensin (0.25 to 1.13 pounds § 558.360 Morantel tartrate. or 4 to 18 ounces of block) per head per (a) Approvals. Type A medicated arti- day, at least 1 block per 4 head of cat- cles: 88 grams per pound to 066104 in tle. Do not allow cattle access to salt § 510.600(c) of this chapter. or mineral while being fed this product. (b) Related tolerances. See § 556.425 of Ingestion by cattle of monensin at lev- this chapter. els of 600 milligrams per head per day (c) Special considerations. (1) Do not and higher has been fatal. The effec- use in Type B or Type C medicated tiveness of this block in cull cows and feeds containing bentonite. bulls has not been established. See (2) Consult your veterinarian before paragraph (d)(10)(i) of this section. using in severely debilitated animals (iv) Amount. 400 milligrams per pound and for assistance in the diagnosis, of block (0.088 percent). treatment, and control of parasitism. (a) Sponsor. See No. 051267 in (d) Conditions of use—(1) Amount. 0.44 § 510.600(c) of this chapter. to 4.4 grams of morantel tartrate per (b) Conditions of use—(1) Indications pound of feed. for use. For increased rate of weight gain in pasture cattle (slaughter, (2) Indications for use—(i) Cattle. For stocker, feeder, and dairy and beef re- removal and control of mature gastro- placement heifers). intestinal nematode infections of cat- (2) Limitations. Provide 50 to 200 milli- tle including stomach worms grams of monensin (2 to 8 ounces of (Haemonchus spp., Ostertagia spp., block) per head per day, at least 1 Trichostrongylus spp.), worms of the block per 5 head of cattle. Feed blocks small intestine (Cooperia spp., continuously. Do not feed salt or min- Trichostrongylus spp., Nematodirus spp.), eral supplements in addition to the and worms of the large intestine blocks. Ingestion by cattle of monensin (Oesophagostomum radiatum). at levels of 600 milligrams per head per (ii) Goats. For removal and control of day and higher has been fatal. The ef- mature gastrointestinal nematode in- fectiveness of this block in cull cows fections of goats including Haemonchus and bulls has not been established. See contortus, Ostertagia (Teladorsagia) paragraph (d)(10)(i) of this section. circumcincta, and Trichostrongylus axei. (8) Monensin may also be used in (3) Limitations. Feed as a single thera- combination with: peutic treatment at 0.44 gram of (i) Chlortetracycline as in § 558.128. morantel tartrate per 100 pounds of (ii) Decoquinate as in § 558.195. body weight. Fresh water should be (iii) Lincomycin as in § 558.325. available at all times. When medicated (iv) Melengestrol acetate as in feed is consumed, resume normal feed- § 558.342. ing. Conditions of constant worm expo- (v) Oxytetracycline as in § 558.128. sure may require retreatment in 2 to 4 (vi) Ractopamine alone or in com- weeks. Do not treat cattle within 14 bination as in § 558.500. days of slaughter; do not treat goats (vii) Tilmicosin as in § 558.618. within 30 days of slaughter. (viii) Tylosin as in § 558.625. [46 FR 50950, Oct. 16, 1981, as amended at 47 (ix) Virginiamycin as in § 558.635. FR 53352, Nov. 26, 1982; 51 FR 7399, Mar. 3, (x) Zilpaterol alone or in combina- 1986; 51 FR 9005, Mar. 17, 1986; 52 FR 11642, tion as in § 558.665. Apr. 10, 1987; 59 FR 17922, Apr. 15, 1994; 66 FR 47963, Sept. 17, 2001] [40 FR 13959, Mar. 27, 1975] EDITORIAL NOTES: 1. For FEDERAL REGISTER § 558.363 Narasin. citations affecting § 558.355, see the List of CFR Sections Affected, which appears in the (a) Approvals. Type A medicated arti- Finding Aids section of the printed volume cles containing specified levels of and at www.fdsys.gov. narasin approved for sponsors identi- 2. At 79 FR 13545, Mar. 11, 2014, § 558.355 was fied in § 510.600(c) of this chapter for use amended; however, the amendments to as in paragraph (d) of this section are (f)(1)(vii)(b) and (f)(4)(iv)(b) could not be in- as follows:

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(1) To 058198: 36, 45, 54, 72, and 90 (iii) Amount per ton. Narasin, 54 to 72 grams per pound, paragraph (d)(1)(i) of grams, plus bambermycins, 1 to 2 this section. grams. (2) [Reserved] (A) Indications for use. For prevention (3) To 058198: 36 grams per pound, of coccidiosis caused by Eimeria with 36 grams per pound nicarbazin, necatrix, E. tenella, E. acervulina, E. paragraph (d)(1)(iii) of this section. brunetti, E. mivati, and E. maxima, and (4) To 016592: 36, 45, 54, 72, and 90 for increased rate of weight gain and grams per pound, with 2 and 10 grams improved feed efficiency. per pound bambermycins, paragraph (B) Limitations. For broiler chickens (d)(1)(iv) of this section. only. Feed continuously as the sole ra- (5)–(6) [Reserved] tion. May be fatal if fed to adult tur- (7) To 054771: 36, 45, 54, 72, or 90 grams keys, horses, or other equines. Narasin per pound, with 10, 25, 40, or 50 grams as provided by No. 058198; per pound bacitracin zinc, paragraph bambermycins by No. 016592 in (d)(1)(x) of this section. (8) To 058198: 45.4 grams per pound for § 510.600(c) of this chapter. use as in paragraph (d)(2) of this sec- (iv) Amount per ton. Narasin 54 to 72 tion. grams, and bacitracin (b) Tolerances. See § 556.428 of this methylenedisalicylate 10 to 50 grams. chapter. (A) Indications for use. For the pre- (c) Special considerations. An expira- vention of coccidiosis caused by Eimeria tion date of 2 months (8 weeks) is re- acervulina, E. brunetti, E. maxima, E. quired for narasin Type C medicated mivati, E. necatrix, and E. tenella, for in- swine feeds. creased rate of weight gain, and for im- (d) Conditions of use. It is used as fol- proved feed efficiency. lows: (B) Limitations. For broiler chickens (1) Broiler chickens—(i) Amount per only. Feed continuously as sole ration. ton. Narasin, 54 to 90 grams. Do not feed to laying hens. Do not (A) Indications for use. For prevention allow adult turkeys, horses, or other of coccidiosis caused by Eimeria equines access to narasin formulations. necatrix, E. tenella, E. acervulina, E. Ingestion of narasin by these species brunetti, E. mivati, and E. maxima. has been fatal. Narasin as provided by (B) Limitations. For broiler chickens 058198, bacitracin only. Feed continuously as sole ration. methylenedisalicylate by 046573 in Do not allow adult turkeys, horses, or § 510.600(c) of this chapter. other equines access to narasin formu- (v) Amount per ton. Narasin, 54 to 72 lations. Ingestion of narasin by these grams and bacitracin zinc, 4 to 50 species has been fatal. grams. (ii) Amount per ton. Narasin, 27 to 45 (A) Indications for use. For the pre- grams, plus nicarbazin, 27 to 45 grams. vention of coccidiosis caused by Eimeria (A) For the pre- Indications for use. necatrix, E. tenella, E. acervulina, E. vention of coccidiosis caused by Eimeria brunetti, E. mivati, and E. maxima, and necatrix, E. tenella, E. acervulina, E. for increased rate of weight gain and brunetti, E. mivati, and E. maxima. improved feed efficiency. (B) Limitations. For broiler chickens only. Feed continuously as the sole ra- (B) Limitations. For broiler chickens tion. Do not feed to laying hens. Do not only. Feed continuously as sole ration. allow adult turkeys, horses, or other Do not allow adult turkeys, horses, or equines access to formulations con- other equines access to formulations taining narasin. Ingestion of narasin containing narasin. Ingestion of by these animals has been fatal. With- narasin by these species has been fatal. draw 5 days before slaughter. The 2 Narasin as provided by 058198, baci- drugs can be combined only at a 1:1 tracin zinc by 046573 in § 510.600(c) of ratio for the 27 to 45 grams per ton this chapter. range. Only granular nicarbazin as pro- (vi) [Reserved] vided by No. 058198 in § 510.600(c) of this (2) Growing-finishing swine—(i) chapter may be used in the combina- Amount per ton. Narasin, 13.6 to 27.2 tion. grams.

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(A) Indications for use. For increased these animals. Swine being fed with rate of weight gain when fed for at narasin should not have access to feeds least 4 weeks. containing pleuromutilins (e.g., (B) Limitations. Feed continuously for tiamulin) as adverse reactions may at least 4 weeks to swine during the occur. If signs of toxicity occur, dis- growing-finishing period as the sole ra- continue use. tion. No increased benefit in rate of (3) Narasin may also be used for weight gain has been shown when broilers in combination with: narasin concentrations in the diet are (i) Nicarbazin with lincomycin as in greater than 13.6 g/ton. Effectiveness § 558.366. has not been demonstrated when fed (ii) Nicarbazin and bacitracin for durations less than 4 weeks. Do not methylenedisalicylate as in § 558.366. allow adult turkeys, horses, or other [51 FR 29098, Aug. 14, 1986] equines access to narasin formulations. Ingestion of narasin by these species EDITORIAL NOTES: 1. For FEDERAL REGISTER has been fatal. Not approved for use in citations affecting § 558.363, see the List of CFR Sections Affected, which appears in the breeding animals because safety and ef- Finding Aids section of the printed volume fectiveness have not been evaluated in and at www.fdsys.gov. these animals. Swine being fed with 2. At 79 FR 13545, Mar. 11, 2014, § 558.363 was narasin should not have access to feeds amended; however, the amendment could not containing pleuromutilins (e.g., be incorporated because of an inaccurate tiamulin) as adverse reactions may amendatory instruction. occur. If signs of toxicity occur, discontinue use. § 558.364 Neomycin sulfate. (ii) Amount per ton. Narasin, 18.1 to (a) Specifications. Type A medicated 27.2 grams. article containing 325 grams neomycin (A) Indications for use. For increased sulfate per pound. rate of weight gain and improved feed (b) Sponsor. See No. 054771 in efficiency when fed for at least 4 weeks. § 510.600(c) of this chapter. (B) Limitations. Feed continuously for (c) Related tolerances. See § 556.430 of at least 4 weeks to swine during the this chapter. growing-finishing period as the sole ra- (d) Special considerations. (1) Federal tion. No increased benefit in rate of law restricts medicated feed containing weight gain has been shown when this veterinary feed directive (VFD) narasin concentrations in the diet are drug to use by or on the order of a li- greater than 13.6 g/ton. Effectiveness censed veterinarian. See § 558.6 for addi- has not been demonstrated when fed tional requirements. for durations less than 4 weeks. Do not (2) The expiration date of VFDs for allow adult turkeys, horses, or other neomycin medicated feeds must not ex- equines access to narasin formulations. ceed 6 months from the date of Ingestion of narasin by these species issuance. VFDs for neomycin shall not has been fatal. Not approved for use in be refilled. breeding animals because safety and ef- (e) Conditions of use. Neomycin sul- fectiveness have not been evaluated in fate is used as follows:

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Neomycin Sulfate Combination Indications for Use Limitations Sponsor

(1) 250 to 2,250 ...... Cattle, swine, sheep, and goats. For To provide 10 milligrams (mg) 054771 grams per ton treatment and control of of neomycin sulfate per (g/t) of dry type colibacillosis (bacterial enteritis) pound of body weight per C feed.. caused by Escherichia coli suscep- day for a maximum of 14 tible to neomycin.. days. The concentration of neomycin sulfate required in medicated feed must be adjusted to compensate for variation in age and weight of animal, the nature and severity of disease signs, and environmental temperature and humidity, each of which af- fects feed consumption. If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. Discontinue treatment prior to slaughter as follows: Cattle 1 day, swine 3 days, sheep 2 days, and goats 3 days. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle or lactating dairy goats. Do not use in female dairy cattle 20 months of age or older or female dairy goats 12 months of age or older. For use in dry feeds only. Not for use in liquid feed supplements.. (2) 400 to 2,000 ...... Do...... To provide 10 mg of neomycin 054771 g/t of type C sulfate per pound of body milk replacer.. weight per day for a maximum of 14 days. Amount consumed will vary depending on animal’s consumption and weight. If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. Discontinue treatment prior to slaughter as follows: Cattle 1 day, swine 3 days, sheep 2 days, and goats 3 days. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle or lactating dairy goats. Do not use in female dairy cattle 20 months of age or older or female dairy goats 12 months of age or older. For use in milk replacers only..

[64 FR 70576, Dec. 17, 1999, as amended at 65 FR 45881, July 26, 2000; 79 FR 13545, Mar. 11, 2014; 81 FR 95009, Dec. 27, 2016]

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§ 558.365 Nequinate. (ii) Indications for use. An aid in the prevention of coccidiosis caused by E. (a) Approvals. Type A medicated arti- tenella, E. necatrix, E. acervulina, E. cles: 4 percent to No. 051311 in maxima, E. brunetti, and E. mivati. § 510.600(c) of this chapter. (iii) Limitations. Feed continuously as (b) Related tolerances. See § 556.440 of the sole ration; do not feed to chickens this chapter. over 16 weeks of age. (c) Special considerations. Do not use in Type B or Type C medicated feeds [40 FR 13959, Mar. 27, 1975, as amended at 51 containing bentonite. FR 7399, Mar. 3, 1986; 52 FR 2685, Jan. 26, 1987; 66 FR 45167, Aug. 28, 2001; 70 FR 32489, June 3, (d) Conditions of use. It is used as fol- 2005] lows: (1) Broiler or fryer chickens—(i) § 558.366 Nicarbazin. Amount per ton. Nequinate, 18.16 grams. (a) Specifications. Type A medicated (ii) Indications for use. An aid in the articles containing 25 percent prevention of coccidiosis caused by E. nicarbazin. tenella, E. necatrix, E. acervulina, E. (b) Approvals. See Nos. 058198, 060728, maxima, E. brunetti, and E. mivati. and 066104 in § 510.600(c) of this chapter (iii) Limitations. Feed continuously as for use as in paragraph (d) of this sec- the sole ration. tion. (2) Roaster chickens or replacement (c) Related tolerances. See § 556.445 of chickens for caged layers—(i) Amount per this chapter. ton. Nequinate, 18.16 grams (0.002 per- (d) Conditons of use. It is used in cent). chicken feed as follows:

Nicarbazin in Combination in grams per ton grams per ton Indications for use Limitations Sponsor

27 to 45 ...... Narasin 27 to 45 ...... Broiler chickens; prevention of coc- Sec. 558.363(d)(1)(iii) ...... 058198 cidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati.. Narasin 27 to 45 and Broiler chickens; prevention of coc- Feed continuously as sole ra- 058198 bacitracin cidiosis caused by Eimeria tenella, tion. Withdraw 5 days before methylenedisalicyl- E. necatrix, E. acervulina, E. maxi- slaughter. Do not allow tur- ate 4 to 50. ma, E. brunetti, E. mivati; for in- keys, horses, or other creased rate of weight gain and im- equines access to formula- proved feed efficiency. tions containing narasin. In- gestion of narasin by these species has been fatal. Do not feed to laying hens. Narasin and nicarbazin as provided by 058198, bacitracin methylenedisalicylate by 054771. Narasin 27 to 45 and Broiler chickens: For prevention of Feed continuously as sole ra- 054771 bacitracin coccidiosis caused by Eimeria tion. Do not feed to laying methylenedisalicyl- tenella, E. necatrix, E. acervulina, hens. Withdraw 5 days be- ate 50.. E. maxima, E. brunetti, and E. fore slaughter. Do not allow mivati; as an aid in the prevention turkeys, horses or other of necrotic enteritis caused or com- equines access to formula- plicated by Clostridium spp. or tions containing narasin. In- other organisms susceptible to bac- gestion of narasin by these itracin.. species has been fatal. Narasin and nicarbazin as provided by No. 058198, bacitracin methylenedisalicylate by No. 054771 in § 510.600(c) of this chapter..

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Nicarbazin in Combination in grams per ton grams per ton Indications for use Limitations Sponsor

Narasin 27 to 45 and Broiler chickens: For prevention of To control necrotic enteritis, 054771 bacitracin coccidiosis caused by Eimeria start medication at first clin- methylenedisalicyl- tenella, E. necatrix, E. acervulina, ical signs of disease; vary ate 100 to 200.. E. maxima, E. brunetti, and E. dosage based on the severity mivati; as an aid in the control of of infection; administer con- necrotic enteritis caused or com- tinuously for 5 to 7 days or plicated by Clostridium spp. or as long as clinical signs per- other organisms susceptible to bac- sist, then reduce bacitracin to itracin.. prevention level (50 g/ton). Do not feed to laying hens. Withdraw 5 days before slaughter. Do not allow turkeys, horses or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Narasin and nicarbazin as provided by No. 058198, bacitracin methylenedisalicylate by No. 054771 in § 510.600(c) of this chapter.. Narasin 27 to 45, Broiler chickens: As an aid in pre- Feed continuously as sole ra- 058198 and bambermycins venting outbreaks of cecal (Eimeria tion from time chicks are 1 to 2. tenella) and intestinal (E. placed on litter until past the acervulina, E. maxima, E. necatrix, time when coccidiosis is ordi- and E. brunetti) coccidiosis; and for narily a hazard; do not use increased rate of weight gain and as a treatment for coccidi- improved feed efficiency.. osis; do not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter. Bambermycins provided by No. 016592; nicarbazin and narasin by No. 066104 in § 510.600(c) of this chapter. 90.8 to 181.6 ...... Broiler chickens: As an aid in pre- Feed continuously as sole ra- 066104 (0.01 to 0.02 venting outbreaks of cecal (Eimeria tion from time chicks are pct). tenella) and intestinal (E. placed on litter until past the acervulina, E. maxima, E. necatrix, time when coccidiosis is ordi- and E. brunetti) coccidiosis. narily a hazard. Do not use as a treatment for coccidiosis. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. With- draw 5 days before slaughter for use levels above 113.5 g/ ton. Bacitracin Broiler chickens: As an aid in pre- Feed continuously as sole ra- 054771 methylenedisalicyl- venting outbreaks of cecal (Eimeria tion from time chicks are ate 4 to 50. tenella) and intestinal (E. placed on litter until past the acervulina, E. maxima, E. necatrix, time when coccidiosis is ordi- and E. brunetti) coccidiosis; for in- narily a hazard. Do not use creased rate of weight gain and im- as a treatment for coccidi- proved feed efficiency. osis. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. With- draw 5 days before slaughter for use levels above 113.5 g/ ton. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter.

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Nicarbazin in Combination in grams per ton grams per ton Indications for use Limitations Sponsor

Bacitracin Broiler chickens: As an aid in pre- Feed continuously as sole ra- 066104 methylenedisalicyl- venting outbreaks of cecal (Eimeria tion from time chicks are ate 30. tenella) and intestinal (E. placed on litter until past the acervulina, E. maxima, E. necatrix, time when coccidiosis is ordi- and E. brunetti) coccidiosis; for in- narily a hazard. Do not use creased rate of weight gain and im- as a treatment for coccidi- proved feed efficiency. osis. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. With- draw 5 days before slaughter for use levels above 113.5 g/ ton. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. Bacitracin Broiler chickens: As an aid in pre- Feed continuously as sole ra- 054771 methylenedisalicyl- venting outbreaks of cecal (Eimeria tion from time chicks are ate 50. tenella) and intestinal (E. placed on litter until past the acervulina, E. maxima, E. necatrix, time when coccidiosis is ordi- and E. brunetti) coccidiosis; as an narily a hazard. Do not use aid in the prevention of necrotic en- as a treatment for coccidi- teritis caused or complicated by osis. Do not feed to laying Clostridium spp. or other organisms hens. Withdraw 4 days be- susceptible to bacitracin. fore slaughter for use levels at or below 113.5 g/ton. With- draw 5 days before slaughter for use levels above 113.5 g/ ton. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. 113.5 (0.0125 ...... Chickens; aid in preventing outbreaks Feed continuously as sole ra- 058198 pct). of cecal (Eimeria tenella) and intes- tion from time chicks are 060728 tinal (E. acervulina, E. maxima, E. placed on litter until past the necatrix, and E. brunetti) coccidi- time when coccidiosis is ordi- osis. narily a hazard; do not use as a treatment for coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter. Bacitracin Broiler chickens; aid in preventing ...... do ...... 060728 methylenedisalicyl- outbreaks of cecal (Eimeria tenella) ate 30. and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; for increased rate of weight gain and improved feed efficiency. Bacitracin zinc 4 to Broiler chickens; aid in preventing For broiler chickens only. Feed 066104 50.. outbreaks of cecal (Eimeria tenella) continuously as sole ration 054771 and intestinal (E. acervulina, E. from time chicks are placed maxima, E. necatrix, and E. on litter until past the time brunetti) coccidiosis, and for in- when coccidiosis is ordinarily creased rate of weight gain and im- a hazard. Discontinue medi- proved feed efficiency.. cation 4 days before marketing the birds for human consumption to allow for elimination of the drug from edible tissue. Do not feed to laying hens in production. Nicarbazin as provided by 066104, bacitracin zinc by 054771..

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Nicarbazin in Combination in grams per ton grams per ton Indications for use Limitations Sponsor

Bambermycins 1 to 2 Broiler chickens; aid in preventing Feed continuously as sole ra- 057926 outbreaks of cecal (Eimeria tenella) tion from time chicks are and intestinal (E. acervulina, E. placed on litter until past the maxima, E. necatrix, and E. time when coccidiosis is ordi- brunetti) coccidiosis, for increased narily a hazard; do not use rate of weight gain and improved as a treatment for coccidi- feed efficiency.. osis; do not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter. Nicarbazin as provided by 066104.. Bambermycins 1 to 2 Broiler chickens: For prevention of Feed continuously as sole ra- 016592 coccidiosis caused by Eimeria tion. Bambermycins provided tenella, E. necatrix, E. acervulina, by No. 016592 in E. brunetti, E. mivati, and E. maxi- § 510.600(c) of this chapter. ma; and for increased rate of weight gain and improved feed efficiency..

[42 FR 56729, Oct. 28, 1977; 43 FR 1942, Jan. 13, feed 5 to 7 days; withdraw 4 days before 1978, as amended at 44 FR 40887, July 13, 1979; slaughter. 50 FR 13562, Apr. 5, 1985; 51 FR 7399, Mar. 3, (ii) Amount. Novobiocin, 10–14 mgs. 1986; 54 FR 1928, Jan. 18, 1989; 60 FR 29483, per lb. body weight per day. June 5, 1995; 61 FR 1832, Jan. 24, 1996; 61 FR 14021, Mar. 29, 1996; 61 FR 14483, Apr. 2, 1996; (a) Indications for use. Treatment of 62 FR 29011, May 29, 1997; 63 FR 13124, Mar. 18, staphylococcal synovitis and general- 1998; 63 FR 57248, Oct. 27, 1998; 64 FR 4966, ized staphylococcal infections suscep- Feb. 2, 1999; 64 FR 18574, Apr. 15, 1999; 64 FR tible to novobiocin. 20164, Apr. 26, 1999; 64 FR 49384, Sept. 13, 1999; (b) Limitations. Administer, as sole ra- 65 FR 11889, Mar. 7, 2000; 66 FR 46706, Sept. 7, tion, feed which contains not less than 2001; 66 FR 47962, Sept. 17, 2001; 66 FR 63500, 350 grams of novobiocin activity per Dec. 7, 2001; 67 FR 30327, May 6, 2002; 71 FR 16224, Mar. 31, 2006; 71 FR 27957, May 15, 2006; ton of feed; not for laying chickens; 73 FR 15884, Mar. 26, 2008; 75 FR 7555, Feb. 22, feed 5 to 7 days; withdraw 4 days before 2010; 78 FR 23, Jan. 2, 2013; 78 FR 42007, July slaughter. 15, 2013; 78 FR 52429, Aug. 23, 2013; 79 FR 10983, (2) Turkeys—(i) Amount. Novobiocin, Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014; 81 FR 4–5 mgs. per lb. body weight per day. 17609, Mar. 30, 2016; 81 FR 48703, July 26, 2016; (a) Indications for use. Aid in the 81 FR 67153, Sept. 30, 2016; 81 FR 95009, Dec. treatment of breast blisters associated 27, 2016; 82 FR 58557, Dec. 13, 2017] with staphylococcal infections suscep- § 558.415 Novobiocin. tible to novobiocin. (b) Limitations. Administer, as sole ra- (a) Specifications. Type A medicated tion, feed which contains not less than article containing 25 grams of 200 grams of novobiocin activity per novobiocin activity per pound. ton of feed; not for laying turkeys; feed (b) Sponsor. See No. 054771 in 5 to 7 days; withdraw 4 days before § 510.600(c) of this chapter. slaughter. (c) Related tolerances. See § 556.460 of (ii) Amount. Novobiocin, 5–8 mgs. per this chapter. lb. body weight per day. (d) Conditions of use. It is used in ani- (a) Indications for use. Aid in the con- mal feeds as follows: trol of recurring outbreaks of fowl (1) Chickens—(i) Amount. Novobiocin, cholera caused by strains of Pasteurella 6–7 mgs. per lb. body weight per day. multocida susceptible to novobiocin fol- (a) Indications for use. Aid in the lowing initial treatment with 7–8 mgs. treatment of breast blisters associated per pound body weight per day. with staphylococcal infections suscep- (b) Limitations. Administer, as sole ra- tible to novobiocin. tion, feed which contains not less than (b) Limitations. Administer, as sole ra- 200 grams of novobiocin activity per tion, feed which contains not less than ton of feed; feed 5 to 7 days; not for lay- 200 grams of novobiocin activity per ing turkeys; withdraw 4 days before ton of feed; not for laying chickens; slaughter.

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(iii) Amount. Novobiocin, 7–8 mgs. per and mycotic diarrhea (Candida lb. body weight per day. albicans). (a) Indications for use. Treatment of (ii) Limitations. Growing and laying staphylococcal synovitis and general- chickens; growing turkeys. ized staphylococcal infection suscep- (2) Amount. 100 grams per ton. tible to novobiocin; treatment of acute (i) Indications for use. Chickens and outbreaks of fowl cholera caused by turkeys; treatment of crop mycosis and strains of Pasteurella multocida suscep- mycotic diarrhea (Candida albicans). tible to novobiocin. (ii) Limitations. Growing and laying (b) Limitations. Administer, as sole ra- chickens; growing turkeys; to be fed tion, feed which contains not less than for 7 to 10 days. 350 grams of novobiocin activity per [41 FR 11002, Mar. 15, 1976, as amended at 51 ton of feed; feed 5 to 7 days; not for lay- FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; ing turkeys; withdraw 4 days before 53 FR 40729, Oct. 18, 1988; 55 FR 8461, Mar. 8, slaughter. 1990; 57 FR 8578, Mar. 11, 1992; 79 FR 13545, (3) Mink—(i) Amount. 20 mgs. per lb. Mar. 11, 2014] body weight per day. (ii) Indications for use. For treatment § 558.450 Oxytetracycline. of generalized infections, abscesses, or (a) Specifications. Each pound of Type urinary infections caused by staphy- A medicated article contains: lococcal or other novobiocin sensitive (1) Oxytetracycline (from oxytetra- organisms. cycline quaternary salt) equivalent to (iii) Limitations. Administer, as sole 50 or 100 grams oxytetracycline hydro- ration, feed which contains not less chloride; or oxytetracycline (from oxy- than 200 grams of novobiocin activity tetracycline dihydrate base) equivalent per ton of feed; feed for 7 days. to 10, 30, 50, 100, or 200 grams oxytetra- (4) Ducks—(i) Amount. Novobiocin, 350 cycline hydrochloride. grams per ton. (2) Oxytetracycline (from oxytetra- (ii) Indications for use. Control of in- cycline dihydrate base) equivalent to fectious serositis and fowl cholera in 50, 100, or 200 grams oxytetracycline ducks caused by Pasteurella hydrochloride; or 100 grams oxytetra- anatipestifer and P. multocida, suscep- cycline hydrochloride. tible to novobiocin. (b) Sponsors. See sponsors in (iii) Limitations. Administer, as sole § 510.600(c) of this chapter as follows: ration, for 5 to 7 days, continue medi- (1) No. 066104: Type A medicated arti- cation for 14 days if necessary, repeat if cles as in paragraph (a)(1) of this sec- reinfection occurs; discontinue use at tion. least 3 days before slaughter; not for (2) No. 069254: Type A medicated arti- use in laying ducks. cles as in paragraph (a)(2) of this section. [40 FR 13959, Mar. 27, 1975, as amended at 45 (c) Related tolerances. See § 556.500 of FR 42263, June 24, 1980; 51 FR 7399, Mar. 3, this chapter. 1986; 52 FR 36402, Sept. 29, 1987; 79 FR 13545, (d) Special considerations. (1) Federal Mar. 11, 2014] law restricts medicated feed containing § 558.430 Nystatin. this veterinary feed directive (VFD) drug to use by or on the order of a li- (a) Specifications. Type A medicated censed veterinarian. See § 558.6 for addi- article containing 20 grams of nystatin tional requirements. activity per pound. (2) The expiration date of VFDs for (b) Sponsor. See No. 054771 in oxytetracycline medicated feeds must § 510.600(c) of this chapter. not exceed 6 months from the date of (c) Related tolerances. See § 556.470 of issuance. VFDs for oxytetracycline this chapter. shall not be refilled. (d) Conditions of use. It is used for (3) In accordance with § 558.5, labeling chickens and turkeys as follows: shall bear the statement: ‘‘For use in (1) Amount. 50 grams per ton. dry animal feed only. Not for use in liq- (i) Indications for use. Chickens and uid feed supplements.’’ turkeys; aid in control of crop mycosis (e) Conditions of use—(1) Chickens—

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Oxytetracycline Combination in amount grams/ton Indications for use Limitations Sponsor

(i) 100 to 200 g/ ...... Chickens: For control of infec- Feed continuously for 7 to 14 066104 ton. tious synovitis caused by days. Do not feed to chickens 069254 Mycoplasma synoviae and producing eggs for human control of fowl cholera caused consumption. Do not use in by Pasteurella multocida sus- feed containing less than ceptible to oxytetracycline. 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Zero-day withdrawal period. (ii) 200 g/ton ...... Monensin, 90 to 110 Broiler chickens: As an aid in Feed continuously as the sole 066104 the prevention of coccidiosis ration. Do not feed to laying caused by Eimeria necatrix, E. chickens. Do not feed to tenella, E. acervulina, E. chickens over 16 weeks of brunetti, E. mivati, and E. age. Do not use in feed con- maxima; and for the control of taining less than 0.55% die- complicated chronic res- tary calcium. Use in such low piratory disease (CRD or air calcium feeds may result in sac infection) caused by violative residues. Withdraw Mycoplasma gallisepticum and 72 hours before slaughter. Escherichia coli. See § 558.355(d) of this chapter Oxytetracycline as provided by No. 066104; monensin as provided by No. 058198 in § 510.600(c) of this chapter. (iii) 400 g/ton ...... Chickens: For control of chronic Feed continuously for 7 to 14 066104 respiratory disease (CRD) and days. Do not feed to chickens 069254 air sac infection caused by producing eggs for human Mycoplasma gallisepticum and consumption. Do not use in Escherichia coli susceptible to feed containing less than oxytetracycline. 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Zero-day withdrawal period. (iv) 400 g/ton...... Robenidine, 30 ...... Broiler chickens: As an aid in Feed continuously for 7 to 14 066104 the prevention of coccidiosis days. Do not feed to chickens caused by Eimeria necatrix, E. producing eggs for human tenella, E. acervulina, E. consumption. Do not use in brunetti, E. mivati, and E. feed containing less than maxima; and for the control of 0.55% dietary calcium. Use in chronic respiratory disease such low calcium feeds may (CRD) and air sac infection result in violative residues. caused by Mycoplasma Withdraw 5 days before gallisepticum and Escherichia slaughter. Oxytetracycline as coli susceptible to oxytetra- provided by No. 066104; cycline. robenidine as provided by No. 054771 in § 510.600(c) of this chapter. (v) 500 g/ton ...... Chickens: For reduction of mor- Feed continuously for 5 days. 066104 tality due to air sacculitis (air Do not feed to chickens pro- 069254 sac infection) caused by E. ducing eggs for human con- coli susceptible to oxytetra- sumption. Do not use in feed cycline. containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 24 hours before slaughter.

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Oxytetracycline Combination in amount grams/ton Indications for use Limitations Sponsor

(vi) 500 g/ton ...... Monensin, 90 to 100 Broiler chickens: As an aid in Feed for 5 days as the sole ra- 066104 the prevention of coccidiosis tion. Treat at first clinical signs caused by Eimeria necatrix, E. of the disease. Do not feed to tenella, E. acervulina, E. laying chickens. Do not feed brunetti, E. mivati, and E. to chickens over 16 weeks of maxima; and as an aid in the age. Do not use in feed con- reduction of mortality due to taining less than 0.55% die- air-sacculitis (air sac infection) tary calcium. Use in such low caused by Escherichia coli calcium feeds may result in sensitive to oxytetracycline. violative residues. Withdraw 72 hours before slaughter. See § 558.355(d) of this chapter. Oxytetracycline as provided by No. 066104; monensin as provided by No. 058198 in § 510.600(c) of this chapter. (vii) 500 g/ton ...... Salinomycin, 40 to Chickens: For the prevention of Feed for 5 days as the sole ra- 066104 60. coccidiosis caused by Eimeria tion. Treat at first clinical signs 016592 necatrix, E. tenella, E. of the disease. Do not feed to acervulina, E. brunetti, E. laying chickens. Do not use in mivati, and E. maxima; and as feed containing less than an aid in the reduction of mor- 0.55% dietary calcium. Use in tality due to air-sacculitis (air such low calcium feeds may sac infection) caused by E. result in violative residues. coli sensitive to oxytetra- Withdraw 24 hours before cycline. slaughter. Oxytetracycline as provided by No. 066104; salinomycin as provided by No. 016592 in § 510.600(c) of this chapter.

(2) Turkeys—

Oxytetracycline amount Indications for use Limitations Sponsor

(i) 100 g/ton...... Turkeys: For control of hexamitiasis Feed continuously for 7 to 14 days. Do 066104 caused by Hexamita meleagridis sus- not feed to turkeys producing eggs for 069254 ceptible to oxytetracycline. human consumption. Zero-day withdrawal period. (ii) 200 g/ton ...... Turkeys: For control of infectious synovitis Feed continuously for 7 to 14 days. Do 066104 caused by M. synoviae susceptible to not feed to turkeys producing eggs for 069254 oxytetracycline. human consumption. For No. 066104, withdraw 5 days before slaughter. For No. 069254, zero-day withdrawal period. (iii) 25 mg/lb of body Turkeys: For control of complicating bac- Feed continuously for 7 to 14 days. Do 066104 weight daily. terial organisms associated with not feed to turkeys producing eggs for 069254 bluecomb (transmissible enteritis; human consumption. For No. 066104, coronaviral enteritis) susceptible to oxy- withdraw 5 days before slaughter. For tetracycline. No. 069254, zero-day withdrawal period.

(3) Swine—

Oxytetracycline Combination in amount grams/ton Indications for use Limitations Sponsor

(i) 10 mg/lb of ...... 1. Swine: For treatment of bac- Feed continuously for 7 to 14 066104 body weight terial enteritis caused by days. 069254 daily. Escherichia coli and Sal- monella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline.

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Oxytetracycline Combination in amount grams/ton Indications for use Limitations Sponsor

2. Breeding swine: For control Feed continuously for 14 days ... 066104 and treatment of leptospirosis 069254 (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline. (ii) 10 mg/lb of Carbadox, 10 to 25 Swine: For treatment of bacterial Feed continuously as the sole 066104 body weight enteritis caused by E. coli and ration for 7 to 14 days. Not for daily. Salmonella choleraesuis sus- use in pregnant swine or ceptible to oxytetracycline and swine intended for breeding treatment of bacterial pneu- purposes. Do not mix in feeds monia caused by Pasteurella containing bentonite. Do not multocida susceptible to oxy- feed to swine within 42 days tetracycline; and for increased of slaughter. Oxytetracycline rate of weight gain and im- and carbadox as provided by proved feed efficiency. No. 066104 in § 510.600(c) of this chapter.

(4) Cattle—

Oxytetracycline Combination in amount grams/ton Indications for use Limitations Sponsor

(i) 10 mg/lb of ...... 1. Calves and beef and nonlac- Feed continuously for 7 to 14 066104 body weight tating dairy cattle: For treat- days. For No. 069254, with- 069254 daily. ment of bacterial enteritis draw 5 days before slaughter. caused by Escherichia coli For No. 066104, zero-day and bacterial pneumonia withdrawal period. (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline. 2. Calves: For treatment of bac- Feed continuously for 7 to 14 066104 terial enteritis caused by E. days in milk replacer or starter 069254 coli susceptible to oxytetra- feed. This product is not ap- cycline. proved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. For No. 069254, withdraw 5 days before slaughter. For No. 066104, zero-day withdrawal period. (ii) 75 mg/head/ ...... Growing cattle (over 400 lb): For Feed continuously ...... 066104 day. reduction of incidence of liver 069254 abscesses. (iii) 75 mg/head/ Lasalocid 25 to 30.. Heifers fed in confinement for Feed continuously to provide 054771 day. slaughter (over 400 lb): For 250 to 360 mg lasalocid and reduction of incidence of liver 75 mg of oxytetracycline per abscesses; and for increased head per day. Lasalocid as rate of weight gain and im- provided by No. 054771 in proved feed efficiency. § 510.600(c) of this chapter. (iv) 75 mg/head/ Melengestrol ace- Heifers fed in confinement for Feed continuously to provide 054771 day. tate, 0.25 to 2.0. slaughter (over 400 lb): For 0.25 to 0.5 mg of reduction of incidence of liver melengestrol acetate and 75 abscesses; and for increased mg of oxytetracycline per rate of weight gain, improved head per day. Melengestrol as feed efficiency, and suppres- provided by No. 054771 in sion of estrus (heat). § 510.600(c) of this chapter. (v) 0.5 to 2.0 g/ ...... Cattle: For prevention and treat- Feed 3 to 5 days before and 066104 head/day. ment of the early stages of after arrival in feedlots. 069254 shipping fever complex.

(5) Minor species—

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Oxytetracycline amount Indications for use Limitations Sponsor

(i) 10 mg/lb of body Sheep: For treatment of bacterial enter- Feed continuously for 7 to 14 days; 066104 weight daily. itis caused by E. coli and bacterial withdraw 5 days before slaughter. 069254 pneumonia caused by P. multocida susceptible to oxytetracycline. (ii) 200 mg/colony ...... Honey bees: For control of American Remove at least 6 weeks prior to main 066104 foulbrood caused by Paenibacillus lar- honey flow. 069254 vae and European foulbrood caused by Streptococcus pluton susceptible to oxytetracycline. (iii) 250 mg/kilogram of Pacific salmon: For marking of skeletal For salmon not over 30 g body weight; 066104 fish/day (11.35 g/100 lb tissue. administer as sole ration for 4 con- of fish/day). secutive days; fish not to be liberated for at least 7 days following the last administration of medicated feed. (iv) 2.5 to 3.75 g/100 lb 1. Salmonids: For control of ulcer dis- Administer in mixed ration for 10 days; 066104 of fish/day. ease caused by Haemophilus do not liberate fish or slaughter fish piscium, furunculosis caused by for food for 21 days following the last Aeromonas salmonicida, bacterial administration of medicated feed. hemorrhagic septicemia caused by A. liquefaciens, and pseudomonas disease. 2. Catfish: For control of bacterial hem- Administer in mixed ration for 10 days; 066104 orrhagic septicemia caused by A. do not liberate fish or slaughter fish liquefaciens and pseudomonas dis- for food for 21 days following the last ease. administration of medicated feed; do not administer when water temperature is below 16.7 °C (62 °F). (v) 3.75 g/100 lb of fish/ 1. Freshwater-reared salmonids: For Administer in mixed ration for 10 days; 066104 day. control of mortality due to coldwater do not liberate fish or slaughter fish disease associated with for food for 21 days following the last Flavobacterium psychrophilum. administration of medicated feed. 2. Freshwater-reared Oncorhynchus Administer in mixed ration for 10 days; 066104 mykiss: For control of mortality due to do not liberate fish or slaughter fish columnaris disease associated with for food for 21 days following the last Flavobacterium columnare. administration of medicated feed. (vi) 1 g/lb of medicated Lobsters: For control of gaffkemia Administer as sole ration for 5 consecu- 066104 feed. caused by Aerococcus viridans. tive days; withdraw medicated feed 30 days before harvesting lobsters.

[81 FR 95009, Dec. 27, 2016, as amended at 82 FR 11512, Feb. 24, 2017]

§ 558.455 Oxytetracycline and neomy- drug to use by or on the order of a li- cin. censed veterinarian. See § 558.6 for addi- (a) Specifications. Type A medicated tional requirements. articles containing oxytetracycline (2) The expiration date of VFDs for equivalent to 50 grams per pound (g/lb) oxytetracycline and neomycin medi- oxytetracycline hydrochloride and 50 g/ cated feeds must not exceed 6 months lb neomycin sulfate or oxytetracycline from the date of issuance. VFDs for ox- equivalent to 100 g/lb oxytetracycline ytetracycline and neomycin shall not hydrochloride and 100 g/lb neomycin be refilled. sulfate. (3) Cattle feeds shall bear the fol- (b) Sponsors. See Nos. 066104 and lowing warning statement: ‘‘Use of 069254 in § 510.600(c) of this chapter. more than one product containing neo- (c) Related tolerances. See §§ 556.430 mycin or failure to follow withdrawal and 556.500 of this chapter. times may result in illegal drug resi- (d) Special considerations. (1) Federal dues.’’ law restricts medicated feed containing (e) Indications for use—(1) Chickens. It this veterinary feed directive (VFD) is used in feed as follows:

Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors in grams per ton of feed

(i) [Reserved].

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Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors in grams per ton of feed

(ii) 100 to 200 ...... Chickens: For control of infectious synovitis Feed continuously for 7 to 14 d; do not 066104 caused by Mycoplasma synoviae; control feed to chickens producing eggs for 069254 of fowl cholera caused by Pasteurella human consumption; in low calcium feed, multocida susceptible to oxytetracycline.. withdraw 3 d before slaughter..

(iii) 400 ...... Chickens: For control of chronic respiratory Feed continuously for 7 to 14 d; do not 066104 disease (CRD) and air sac infection feed to chickens producing eggs for 069254 caused by M. gallisepticum and Esch- human consumption; in low calcium erichia coli susceptible to oxytetracycline.. feeds, withdraw 3 d before slaughter..

(iv) 500 ...... Chickens: For reduction of mortality due to Feed continuously for 5 d; do not feed to 066104 air sacculitis (air-sac- infection) caused chickens producing eggs for human con- 069254 by E. coli susceptible to oxytetracycline.. sumption; withdraw 24 hours before slaughter; in low calcium feeds withdraw 3 d before slaughter..

(2) Turkeys. It is used in feed as follows:

Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors

(i) [Reserved].

(ii) 100 g/ton of feed ..... Turkeys: For control of hexamitiasis caused Feed continuously for 7 to 14 d; do not 066104 by Hexamita meleagridis susceptible to feed to turkeys producing eggs for 069254 oxytetracycline.. human consumption..

(iii) 200 g/ton of feed .... Turkeys: For control of infectious synovitis Feed continuously for 7 to 14 d; withdraw 5 066104 caused by M. synoviae susceptible to ox- d before slaughter; do not feed to turkeys 069254 ytetracycline.. producing eggs for human consumption..

(iv) To provide 25 milli- Turkeys: For control of complicating bac- Feed continuously for 7 to 14 d; withdraw 5 066104 grams per pound terial organisms associated with d before slaughter; do not feed to turkeys 069254 (mg/lb) of body bluecomb (transmissible enteritis; producing eggs for human consumption.. weight daily.. coronaviral enteritis) susceptible to oxytetracycline..

(3) Swine. It is used in feed as follows:

Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors

(i) [Reserved].

(ii) To provide 10 mg/lb 1. Swine: For treatment of bacterial enteritis Feed continuously for 7 to 14 d; withdraw 5 066104 of body weight daily.. caused by E. coli and Salmonella d before slaughter.. 069254 choleraesuis and treatment of bacterial pneumonia caused by P. multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin.. 2. Breeding swine: For control and treat- Feed continuously for not more than 14 d; 066104 ment of leptospirosis (reducing the inci- withdraw 5 d before slaughter.. 069254 dence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline..

(4) Cattle and sheep. It is used in feed as follows:

Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors

(i)–(ii) [Reserved].

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Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors

(iii) To provide 10 mg/lb 1. Calves and beef and nonlactating dairy Feed continuously for 7 to 14 d; in feed or 066104 of body weight daily.. cattle: For treatment of bacterial enteritis milk replacers. If symptoms persist after 069254 caused by E. coli and bacterial pneu- using for 2 or 3 days, consult a veteri- monia (shipping fever complex) caused narian. Treatment should continue 24 to by P. multocida susceptible to oxytetra- 48 hours beyond remission of disease cycline; treatment and control of symptoms. A withdrawal period has not colibacillosis (bacterial enteritis) caused been established for use in preruminating by E. coli susceptible to neomycin.. calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. With- draw 5 d before slaughter.. 2. Calves (up to 250 lb): For treatment of Feed continuously for 7 to 14 d; in milk re- 066104 bacterial enteritis caused by E. coli sus- placers or starter feed. If symptoms per- 069254 ceptible to oxytetracycline; treatment and sist after using for 2 or 3 days, consult a control of colibacillosis (bacterial enteritis) veterinarian. Treatment should continue caused by E. coli susceptible to neomy- 24 to 48 hours beyond remission of dis- cin.. ease symptoms. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Withdraw 5 d before slaughter.. 3. Sheep: For treatment of bacterial enter- Feed continuously for 7 to 14 d. If symp- 066104 itis caused by E. coli and bacterial pneu- toms persist after using for 2 or 3 days, 069254 monia caused by P. multocida suscep- consult a veterinarian. Treatment should tible to oxytetracycline; treatment and continue 24 to 48 hours beyond remis- control of colibacillosis (bacterial enteritis) sion of disease symptoms. Withdraw 5 d caused by E. coli susceptible to neomy- before slaughter.. cin..

(iv) [Reserved].

(v) To provide 75 mg/ Growing cattle (over 400 lb): For reduction Feed continuously...... 066104 head/day. of liver condemnation due to liver ab- 069254 scesses..

(vi) To provide 0.5 to Cattle: For prevention and treatment of the Feed 3 to 5 d before and after arrival in 066104 2.0 g/head/ day. early stages of shipping fever complex.. feedlots. A withdrawal period has not 069254 been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older..

[71 FR 16225, Mar. 31, 2006, as amended at 74 FR 40724, Aug. 13, 2009; 80 FR 13232, Mar. 13, 2015; 81 FR 95012, Dec. 27, 2016]

§ 558.464 Poloxalene. complished by adding the Type A arti- (a) Approvals. (1) Dry Type A medi- cle to a small quantity of feed, mixing cated articles: 53 percent to 054771 in thoroughly, then adding this mixture § 510.600(c) of this chapter. to the remaining feed and again mixing (2) Liquid Type A medicated articles: thoroughly. Dosage is 1 gram of 99.5 percent to 054771 in § 510.600(c) of poloxalene per 100 pounds of body this chapter. weight daily and continued during ex- (b) Conditions of use. (1) For preven- posure to bloat producing conditions. If tion of legume (alfalfa, clover) and bloating conditions are severe, the dose wheat pasture bloat in cattle. is doubled. Treatment should be start- (2) Poloxalene dry Type A article and ed 2 to 3 days before exposure to bloat- liquid Type A article must be thor- producing conditions. Repeat dosage if oughly blended and evenly distributed animals are exposed to bloat-producing in feed prior to use. This may be ac- conditions more than 12 hours after the

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last treatment. Do not exceed the high- day introductory feeding should be re- er dosage levels in any 24-hour period. peated. [40 FR 39857, Aug. 29, 1975, as amended at 51 [40 FR 13959, Mar. 27, 1975, as amended at 42 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; FR 21281, Apr. 26, 1977; 51 FR 7399, Mar. 3, 56 FR 50654, Oct. 8, 1991; 60 FR 55660, Nov. 2, 1986; 52 FR 2686, Jan. 26, 1987; 56 FR 50654, 1995; 79 FR 13545, Mar. 11, 2014] Oct. 8, 1991; 60 FR 55660, Nov. 2, 1995; 66 FR 47963, Sept. 17, 2001] § 558.465 Poloxalene free-choice liquid Type C feed. § 558.485 Pyrantel. (a) Specifications. Type A medicated (a) Approvals. Type A medicated arti- articles containing 9.6, 19.2, 48, or 80 cles: 99.5 percent to 066104 in § 510.600(c) grams per pound pyrantel tartrate. of this chapter. (b) Approvals. See sponsors in (b) Conditions of use. (1) For control of § 510.600(c) of this chapter for uses as in legume (alfalfa, clover) and wheat pas- paragraph (e) of this section: ture bloat in cattle, use 7.5 grams of (1) No. 066104: 9.6, 19.2, 48, and 80 poloxalene per pound of liquid Type C grams per pound for use as in para- feed (1.65 percent weight/weight). Each graph (e)(1) of this section. animal must consume 0.2 pound of (2)–(4) [Reserved] Type C feed per 100 pounds of body (5) No. 051311: 19.2 and 48 grams per weight daily for adequate protection. pound for use as in paragraphs (e)(1)(i) (2) For control of legume (alfalfa, clo- through (e)(1)(iii) of this section. ver) bloat in cattle grazing of prebloom (6) [Reserved] legumes, use 10.00 grams of poloxalene (7) Nos. 017135 and 054771: 48 grams per pound of liquid Type C feed (2.2 per- per pound for use as in paragraph (e)(2) cent weight/weight). Each animal must of this section. consume 0.15 pound of Type C feed per (c) Related tolerances. See § 556.560 of 100 pounds of body weight daily for ade- this chapter. (d) Special considerations. (1) See quate protection. If consumption ex- § 500.25 of this chapter. Consult a vet- ceeds 0.2 pound of Type C feed per 100 erinarian before using in severely de- pounds of body weight daily, cattle bilitated animals. should be changed to a Type C feed (2) Do not mix in Type B or Type C containing 7.5 grams of poloxalene per medicated feeds containing bentonite. pound. (e) Conditions of use. It is used as fol- (3) Poloxalene liquid Type A article lows: must be thoroughly blended and evenly (1) Swine—(i) Amount per ton. 96 distributed into a liquid Type C feed grams (0.0106 percent). and offered to cattle in a covered liquid (A) Indications for use. Aid in the pre- Type C feed feeder with lick wheels. vention of migration and establish- The formula for the liquid Type C feed, ment of large roundworm (Ascaris on a weight/weight basis, is as follows: suum) infections; aid in the prevention Ammonium polyphosphate 2.66 percent, of establishment of nodular worm phosphoric acid (75 percent) 3.37 per- (Oesophagostomum) infections. cent, sulfuric acid 1.00 percent, water (B) Limitations. Feed continuously as 10.00 percent, and molasses sufficient the sole ration in a Type C feed; with- to make 100.00 percent, vitamins A and draw 24 hours prior to slaughter. D and/or trace minerals may be added. (ii) Amount per ton. 96 grams (0.0106 One free-turning lick wheel per 25 head percent). of cattle must be provided. (A) Indications for use. For the removal and control of large roundworm (4) The medicated liquid Type C feed (Ascaris suum) infections. must be introduced at least 2 to 5 days (B) Limitations. Feed for 3 days as the before legume consumption to accus- sole ration in a Type C feed; withdraw tom the cattle to the medicated liquid 24 hours prior to slaughter. Type C feed and to lick wheel feedings. (iii) Amount per ton. 800 grams (0.0881 If the medicated liquid wheel Type C percent). feed feeding is interrupted, this 2- to 5- (A) Indications for use. For the removal and control of large roundworm

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(Ascaris suum) and nodular worm § 558.500 Ractopamine. (Oesophagostomum) infections. (B) Limitations. As sole ration for a (a) Specifications. Type A medicated single therapeutic treatment in Type C articles containing 9 or 45.4 grams of feed; feed at the rate of 1 lb of feed per ractopamine hydrochloride per pound. 40 lb of body weight for animals up to (b) Approvals. See Nos. 054771 and 200 lb, and 5 lb of feed per head for ani- 058198 in § 510.600(c) of this chapter. mals 200 lb or over; withdraw 24 hours (c) Related tolerances. See § 556.570 of prior to slaughter. this chapter. (2) Horses—(i) Amount. Feed continu- (d) Special considerations. (1) Labeling ously at the rate of 1.2 milligrams per of Type B and Type C feeds shall bear pound (2.64 milligrams per kilogram) of the following: ‘‘Not for animals in- body weight. tended for breeding.’’ (A) Indications for use. Prevention of (2) Labeling of Type B and Type C Strongylus vulgaris larval infections; swine feeds shall bear the following: control of adult large strongyles (S. (i) ‘‘No increased benefit has been vulgaris, and S. edentatus), adult and 4th stage larvae small strongyles shown when ractopamine concentra- (Cyathostomum spp., Cylicocyclus spp., tions in the diet are greater than 4.5 g/ Cylicostephanus spp., Cylicodontophorus ton.’’ spp., Poteriostomum spp., and (ii) ‘‘Ractopamine may increase the Triodontophorus spp.), adult and 4th number of injured and/or fatigued pigs stage larvae pinworms (Oxyuris equi), during marketing.’’ and adult and 4th stage larvae ascarids (3) Labeling of Type B and Type C (Parascaris equorum). tom turkey feeds shall bear the fol- (B) Limitations. Administer either as lowing: ‘‘No increased benefit has been a top-dress (not to exceed 20,000 grams shown when ractopamine concentra- per ton) or mixed in the horse’s daily tions in the diet are greater than 4.6 g/ grain ration (not to exceed 1,200 grams ton.’’ per ton) during the time that the ani- (4) Tylosin in combinations as mal is at risk of exposure to internal tylosin phosphate. parasites. Not for use in horses intended for food. Consult your veteri- (5) Ractopamine liquid Type B cattle narian before using in severely debili- feeds may be manufactured from dry tated animals and for assistance in the ractopamine Type A articles. The liq- diagnosis, treatment, and control of uid Type B feeds must be maintained parasitism. at a pH of 4.5 to 7.5 or, if in combina- (ii) [Reserved] tion with monensin and/or tylosin, at a (3) Pyrantel may also be used in com- pH of 4.5 to 6.0. Mixing directions for bination with: liquid Type B feeds requiring recircula- (i) Lincomycin as in § 558.325. tion or agitation: Recirculate imme- (ii) Tylosin as in § 558.325. diately prior to use for not less than 10 [40 FR 13959, Mar. 27, 1975] minutes, moving not less than 1 percent of the tank contents per minute EDITORIAL NOTE: For FEDERAL REGISTER ci- from the bottom of the tank to the top. tations affecting § 558.485, see the List of CFR Sections Affected, which appears in the Recirculate daily as described even Finding Aids section of the printed volume when not used. and at www.fdsys.gov. (e) Conditions of use—(1) Swine—

Ractopamine in Combination in grams/ton grams/ton Indications for use Limitations Sponsor

(i) 4.5 to 9.0 ...... For increased rate of weight gain, im- Feed continuously as sole ra- 058198, proved feed efficiency, and in- tion. 054771 creased carcass leanness in finishing swine, weighing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter. (ii)–(iv) [Re- served].

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(2) Cattle—

Ractopamine in Combination in grams/ton grams/ton Indications for use Limitations Sponsor

(i) 8.2 to 24.6 ...... Cattle fed in confinement for slaugh- Feed continuously as sole ra- 058198, ter: For increased rate of weight tion during the last 28 to 42 054771 gain and improved feed efficiency days on feed.. during the last 28 to 42 days on feed. (ii) 8.2 to 24.6 ..... Monensin 10 to 40 to Cattle fed in confinement for slaugh- As in paragraph (e)(2)(i) of this 058198, provide 0.14 to ter: As in paragraph (e)(2)(i) of this section; see paragraph 054771 0.42 mg section; for prevention and control § 558.355(d) of this chapter. monensin/lb of of coccidiosis due to Eimeria bovis Ractopamine as provided by body weight, de- and E zuernii. Nos. 058198 or 054771 in pending on sever- § 510.600(c) of this chapter; ity of coccidiosis monensin as provided by No. challenge, up to 058198 in § 510.600(c) of this 480 mg/head/day. chapter. (iii)–(v) [Re- served]. (vi) 9.8 to 24.6 ...... Cattle fed in confinement for slaugh- Feed continuously as sole ra- 058198, ter: For increased rate of weight tion during the last 28 to 42 054771 gain, improved feed efficiency, and days on feed. Not for animals increased carcass leanness during intended for breeding. the last 28 to 42 days on feed. (vii) 9.8 to 24.6 ... Monensin 10 to 40 to Cattle fed in confinement for slaugh- As in paragraph (e)(2)(vi) of 058198, provide 0.14 to ter: As in paragraph (e)(2)(vi) of this this section; see paragraph 054771 0.42 mg section; for prevention and control § 558.355(d) of this chapter. monensin/lb of of coccidiosis due to Eimeria bovis Ractopamine as provided by body weight, de- and E zuernii. Nos. 058198 or 054771 in pending on sever- § 510.600(c) of this chapter; ity of coccidiosis monensin as provided by No. challenge, up to 058198 in § 510.600(c) of this 480 mg/head/day. chapter. (viii) 9.8 to 24.6 .. Monensin 10 to 40 to Heifers fed in confinement for slaugh- As in paragraph (e)(2)(vi) of 058198, provide 0.14 to ter: As in paragraph (e)(2)(vi) of this this section; see 054771 0.42 mg section; for prevention and control §§ 558.342(d) and 558.355(d) monensin/lb of of coccidiosis due to Eimeria bovis of this chapter. Melengestrol body weight, de- and E. zuernii; and for suppression acetate as provided by Nos. pending on sever- of estrus (heat).. 058198 and 054771 or ity of coccidiosis 021641 in § 510.600(c) of this challenge, up to chapter.. 480 mg/head/day, plus melengestrol acetate to provide 0.25 to 0.5 mg/ head/day. (ix)–(x) [Re- served]. (xi) Not to exceed ...... Cattle fed in confinement for slaugh- Top dress in a minimum of 1.0 058198, 800; to provide ter: As in paragraph (e)(2)(i) of this lb of medicated feed.. 054771 70 to 400 mg/ section.. head/day.. (xii) Not to ex- Monensin 10 to 40 to Cattle fed in confinement for slaugh- Top dress ractopamine in a 058198, ceed 800; to provide 0.14 to ter: As in paragraph (e)(2)(i) of this minimum of 1.0 lb of medi- 054771 provide 70 to 0.42 mg section; for prevention and control cated feed during the last 28 400 mg/head/ monensin/lb of of coccidiosis due to Eimeria bovis to 42 days on feed. Not for day. body weight, de- and E zuernii. animals intended for breed- pending on sever- ing. See § 558.355(d). ity of coccidiosis Ractopamine as provided by challenge, up to Nos. 058198 or 054771 in 480 mg/head/day. § 510.600(c) of this chapter; monensin as provided by No. 058198 in § 510.600(c) of this chapter.

(3) Turkeys—

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Ractopamine in Combination in grams/ton grams/ton Indications for use Limitations Sponsor

(i) 4.6 to 11.8 (5 ...... Finishing hen turkeys: For increased Feed continuously as sole ra- 058198 to 13 ppm). rate of weight gain and improved tion during the last 7 to 14 feed efficiency when fed for the last days prior to slaughter.. 7 to 14 days prior to slaughter.. (ii) 4.6 to 11.8 (5 ...... Finishing tom turkeys: For increased Feed continuously as sole ra- 058198 to 13 ppm). rate of weight gain and improved tion during the last 14 days feed efficiency when fed for the last prior to slaughter. Feeding 14 days prior to slaughter.. ractopamine to tom turkeys during periods of excessive heat can result in increased mortality.. (iii) 4.6 to 11.8 (5 Monensin 54 to 90... Finishing hen turkeys: As in para- Feed continuously as sole ra- 058198 to 13 ppm). graph (e)(3)(i) of this section; and tion during the last 7 to 14 for the prevention of coccidiosis in days prior to slaughter. See growing turkeys caused by Eimeria § 558.355(d).. adenoeides, E. meleagrimitis and E. gallopavonis.. (iv) 4.6 to 11.8 (5 Monensin 54 to 90... Finishing tom turkeys: As in para- Feed continuously as sole ra- 058198 to 13 ppm). graph (e)(3)(ii) of this section; and tion during the last 14 days for the prevention of coccidiosis in prior to slaughter. Feeding growing turkeys caused by Eimeria ractopamine to tom turkeys adenoeides, E. meleagrimitis and during periods of excessive E. gallopavonis.. heat can result in increased mortality. See § 558.355(d)..

(4) Ractopamine may also be used in § 558.515 Robenidine. combination with tylosin in as in (a) Approvals. Type A medicated arti- § 558.625. cles: 30 grams per pound to 054771 in [67 FR 71820, Dec. 3, 2002, as amended at 68 § 510.600(c) of this chapter. FR 54659, Sept. 18, 2003; 69 FR 12068, Mar. 15, (b) Special considerations. Type C feed 2004; 69 FR 51174, Aug. 18, 2004; 71 FR 31074, June 1, 2006; 71 FR 67301, Nov. 21, 2006; 72 FR containing robenidine hydrochloride 10358, Mar. 8, 2007; 72 FR 41619, July 31, 2007; must be fed within 50 days from the 72 FR 56897, Oct. 5, 2007; 72 FR 62571, Nov. 6, date of manufacture. Do not use in 2007; 72 FR 65667, Nov. 23, 2007; 72 FR 70777, Type B or Type C medicated feeds con- Dec. 13, 2007; 73 FR 72715, Dec. 1, 2008; 73 FR taining bentonite. 75323, Dec. 11, 2008; 74 FR 66914, Dec. 17, 2009; (c) Related tolerances. See § 556.580 of 75 FR 1276, Jan. 11, 2010; 75 FR 5888, Feb. 5, 2010; 75 FR 20917, Apr. 22, 2010; 75 FR 54018, this chapter. Sept. 3, 2010; 77 FR 31724, May 30, 2012; 78 FR (d) Conditions of use. It is used in feed 63872, Oct. 25, 2013; 79 FR 13546, Mar. 11, 2014; for chickens as follows: 79 FR 37621, July 2, 2014; 79 FR 44278, July 31, 2014; 79 FR 53136, Sept. 8, 2014; 80 FR 61298, Oct. 13, 2015; 81 FR 48703, July 26, 2016; 81 FR 95013, Dec. 27, 2016]

Robenidine hydrochloride in Combination in Indications for use Limitations Sponsor grams/ton grams/ton

30 (0.0033 pct) ...... Broiler chickens: As an aid in the pre- Feed continuously as sole ra- 054771 vention of coccidiosis caused by E. tion. Do not feed to chickens mivati, E. brunetti, E. tenella, E. producing eggs for food. acervulina, E. maxima, and E. Withdraw 5 days prior to necatrix.. slaughter...... Bacitracin (as baci- For broiler and fryer chickens: As an Feed continuously as sole ra- 054771 tracin aid in the prevention of coccidiosis tion. Do not feed to laying methylenedisalicyl- caused by E. mivati, E. brunetti, E. chickens. Withdraw 5 days ate) 4 to 30. tenella, E. acervulina, E. maxima, prior to slaughter.. and E. necatrix. For increased rate of weight gain...... Bacitracin (as baci- For broiler and fryer chickens: As an Feed continuously as sole ra- 054771 tracin aid in the prevention of coccidiosis tion. Do not feed to laying methylenedisalicyl- caused by E. mivati, E. brunetti, E. chickens. Withdraw 5 days ate) 27 to 50. tenella, E. acervulina, E. maxima, prior to slaughter.. and E. necatrix. For improved feed efficiency..

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Robenidine hydrochloride in Combination in Indications for use Limitations Sponsor grams/ton grams/ton

...... Bacitracin (as baci- For broiler and fryer chickens: As an Feed continuously as sole ra- 054771 tracin aid in the prevention of necrotic en- tion. Do not feed to laying methylenedisalicyl- teritis caused or complicated by hens. Withdraw 5 days be- ate) 50. Clostridium spp. or other organisms fore slaughter.. susceptible to bacitracin...... Bacitracin (as baci- For broiler and fryer chickens: As an To control a necrotic enteritis 054771 tracin aid in the control of necrotic enter- outbreak, start medication at methylenedisalicyl- itis caused or complicated by Clos- first clinical signs of disease; ate) 100 to 200. tridium spp. or other organisms administer continuously for 5 susceptible to bacitracin.. to 7 days or as long as clinical signs persist, then reduce bacitracin methylenedisalicylate to prevention level (50 g/ton). Do not feed to laying hens. With- draw 5 days before slaughter...... Bacitracin (as baci- For broiler and fryer chickens: As an Feed continuously as sole ra- 054771 tracin zinc) 4 to 30. aid in the prevention of coccidiosis tion. Do not feed to laying 054771 caused by E. mivati, E. brunetti, E. chickens. Withdraw 5 days tenella, E. acervulina, E. maxima, prior to slaughter.. and E. necatrix. For increased rate of weight gain...... Bacitracin (as baci- For broiler and fryer chickens: As an Feed continuously as sole ra- 054771 tracin zinc) 27 to aid in the prevention of coccidiosis tion. Do not feed to laying 054771 50. caused by E. mivati, E. brunetti, E. chickens. Withdraw 5 days tenella, E. acervulina, E. maxima, prior to slaughter.. and E. necatrix. For improved feed efficiency..

(e) Robenidine may also be used in tenella, E. necatrix, E. acervulina, E. combination with: maxima, E. brunetti, and E. mivati. (1) Chlortetracycline as in § 558.128. (c) Limitations. Feed continuously as (2) Lincomycin as in § 558.325. sole ration. Do not feed to laying hens (3) Oxytetracycline as in § 558.450. producing eggs for human consump- [40 FR 13959, Mar. 27, 1975] tion. Not approved for use with pellet binders. May be fatal if accidentally EDITORIAL NOTE: For FEDERAL REGISTER ci- fed to adult turkeys or horses. tations affecting § 558.515, see the List of CFR (ii) [Reserved] Sections Affected, which appears in the Finding Aids section of the printed volume (iii)(a) Amount per ton. Salinomycin and at www.fdsys.gov. 40 to 60 grams and bacitracin methylenedisalicylate 4 to 30 grams. § 558.550 Salinomycin. (b) Indications for use. For the preven- (a) Specifications. Type A medicated tion of coccidiosis caused by Eimeria articles containing 30 or 60 grams of tenella, E. necatrix, E. acervulina, E. salinomycin activity per pound (as maxima, E. brunetti, and E. mivati for salinomycin sodium biomass). incresed rate of weight gain and im- (b) Approvals. See sponsors in proved feed efficiency. § 510.600(c) of this chapter for use as in (c) Limitation. Feed continuously as paragraph (d) of this section: sole ration. Not approved for use with (1) No. 016592 for use as in paragraph pellet binders. Do not feed to layers. (d) of this section. May be fatal if accidentially fed to (2) No. 069254 for use as in paragraphs adult turkeys or horses. Bacitracin (d)(1)(xv) and (d)(1)(xvi) of this section. methylenedisalicylate as provided by (c) [Reserved] No. 054771 in § 510.600(c) of this chapter. (d) Conditions of use. (1) Broilers: It is (iv)–(v) [Reserved] used as follows: (vi)(a) Amount per ton. Salinomycin (i)(a) Amount per ton. Salinomycin 40 40 to 60 grams and bacitracin to 60 grams. methylenedisalicylate 4 to 50 grams. (b) Indications for use. For the preven- (b) Indications for use. For the prevention of coccidiosis caused by Eimeria tion of coccidiosis caused by Eimeria

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tenella, E. necatrix, E. acervulina, E. signs of disease; vary dosage based on maxima, E. brunetti, and E. mivati, and the severity of infection; administer for improved feed efficiency. continuously for 5 to 7 days or as long (c) Limitations. Feed continuously as as clinical signs persist, then reduce sole ration. Not approved for use with bacitracin to prevention level (50 pellet binders. Do not feed to layers. grams per ton). Do not feed to laying May be fatal if accidentally fed to chickens. May be fatal if fed to adult adult turkeys or horses. Bacitracin turkeys or to horses. Salinomycin as methylenedisalicylate as provided by provided by 016592; bacitracin No. 054771 in § 510.600(c) of this chapter. methylenedisalicylate as provided by (vii)(a) Amount per ton. Salinomycin 054771 in § 510.600(c) in this chapter. 40 to 60 grams and bacitracin zinc 10 to (xxii) [Reserved] 50 grams. (xxiii) Amount per ton. Salinomycin, (b) Indications for use. For the preven- 40 to 60 grams; plus bambermycins, 1 to tion of coccidiosis caused by Eimeria 3 grams. tenella, E. necatrix, E. acervulina, E. (a) Indications for use. Broiler chick- maxima, E. brunetti, and E. mivati, and ens: For prevention of coccidiosis for increased rate of weight gain. (c) Limitations. Feed continuously as caused by Eimeria tenella, E. necatrix, E. sole ration. Not approved for use with acervulina, E. maxima, E. brunetti, and pellet binders. Do not feed to layers. E. mivati; and for improved feed effi- May be fatal if accidentally fed to ciency. adult turkeys or horses. Bacitracin (b) Limitations. Feed continuously as zinc as provided by No. 054771 in sole ration. Do not feed to laying § 510.600(c) of this chapter. chickens; not approved for use with (viii)–(xix) [Reserved] pellet binders; may be fatal if acciden- (xx)(A) Amount per ton. Salinomycin, tally fed to adult turkeys or horses. 40 to 60 grams; and bacitracin Salinomycin and bambermycins as pro- methylenedisalicylate, 50 grams. vided by No. 016592in § 510.600(c) of this (B) Indications for use. For the pre- chapter. vention of coccidiosis caused by Eimeria (xxiv) [Reserved] tenella, E. necatrix, E. acervulina, E. (2) Quail—(i)(a) Amount per ton. maxima, E. brunetti, and E. mivati, and Salinomycin 50 grams. as an aid in the prevention of necrotic (b) Indications for use. For the preven- enteritis caused or complicated by tion of coccidiosis caused by E. dispersa Clostridium spp. or other organisms sus- and E. lettyae. ceptible to bacitracin. (c) Limitations. Feed continuously as (C) Limitations. Feed continuously as sole ration. Not approved for use with sole ration. Do not feed to laying pellet binders. May be fatal if acciden- chickens. May be fatal if fed to adult tally fed to adult turkeys or horses. Do turkeys or to horses. Salinomycin as not feed to laying hens producing eggs provided by No. 016592; bacitracin for human consumption. methylenedisalicylate as provided by (ii) [Reserved] No. 054771 in § 510.600(c) in this chapter. (xxi)(A) Amount per ton. Salinomycin, (3) Roaster and replacement (breeder 40 to 60 grams; and bacitracin and layer) chickens: It is used as fol- methylenedisalicylate, 100 to 200 lows: grams. (i)(A) Amount per ton. Salinomycin 40 (B) Indications for use. For the pre- to 60 grams. vention of coccidiosis caused by Eimeria (B) Indications for use. For prevention tenella, E. necatrix, E. acervulina, E. of coccidiosis caused by Eimeria tenella, maxima, E. brunetti, and E. mivati, and E. necatrix, E. acervulina, E. maxima, E. as an aid in the control of necrotic en- brunetti, and E. mivati. teritis caused or complicated by Clos- (C) Limitations. Feed continuously as tridium spp. or other organisms suscep- sole ration. Do not feed to laying hens tible to bacitracin. producing eggs for human consump- (C) Limitations. Feed continuously as tion. Not approved for use with pellet sole ration. To control necrotic enter- binders. May be fatal if accidentally itis, start medication at first clinical fed to horses or adult turkeys.

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(ii) Amount per ton. Salinomycin, 40 ing chickens. May be fatal if fed to to 60 grams, and bacitracin adult turkeys or to horses. methylenedisalicylate, 4 to 50 grams. Salinomycin as provided by No. 016592; (A) Indications for use. For the pre- bacitracin methylenedisalicylate as vention of coccidiosis caused by Eimeria provided by No. 054771 in § 510.600(c) of tenella, E. necatrix, E. acervulina, E. this chapter. maxima, E. brunetti, and E. mivati, and (vi)–(vii) [Reserved] for increased rate of weight gain and (4) Chickens: It is used in chicken feed improved feed efficiency. as follows: (B) Limitations. Feed continuously as (i) Amount per ton. Salinomycin, 40 to sole ration. Discontinue use prior to 60 grams; plus oxytetracycline, 500 sexual maturity. Do not feed to laying grams. chickens. May be fatal if fed to adult (a) Indications for use. For prevention turkeys or to horses. Salinomycin as of coccidiosis caused by Eimeria tenella, provided by No. 016592; bacitracin E. necatrix, E. acervulina, E. maxima, E. methylenedisalicylate as provided by brunetti, and E. mivati; and for reduc- No. 054771 in § 510.600(c) of this chapter. tion of mortality due to air sacculitis (iii) Amount per ton. Salinomycin, 40 (air-sac-infection) caused by Esch- to 60 grams, and bacitracin erichia coli susceptible to oxytetra- methylenedisalicylate, 50 grams. cycline. (A) Indications for use. For the pre- (b) Limitations. Feed continuously for vention of coccidiosis caused by Eimeria 5 days; do not feed to chickens pro- tenella, E. necatrix, E. acervulina, E. ducing eggs for human consumption; maxima, E. brunetti, and E. mivati, and withdraw 24 hours before slaughter; in as an aid in the prevention of necrotic low calcium feeds withdraw 3 d before enteritis caused or complicated by slaughter. Salinomycin as provided by Clostridium spp. or other organisms sus- No. 016592; oxytetracycline as provided ceptible to bacitracin. by No. 066104 in § 510.600(c) of this chap- (B) Limitations. Feed continuously as ter. sole ration. Discontinue use prior to (ii) [Reserved] sexual maturity. Do not feed to laying (5) Salinomycin may also be used in chickens. May be fatal if fed to adult combination with: turkeys or to horses. Salinomycin as (i)–(ii) [Reserved] provided by No. 016592; bacitracin (iii) Chlortetracycline as in § 558.128. methylenedisalicylate as provided by (iv) Lincomycin as in § 558.325. No. 054771 in § 510.600(c) of this chapter. [48 FR 30616, July 5, 1983] (iv) [Reserved] (v) Amount per ton. Salinomycin, 40 to EDITORIAL NOTES: 1. For FEDERAL REGISTER 60 grams, and bacitracin citations affecting § 558.550, see the List of CFR Sections Affected, which appears in the methylenedisalicylate, 100 to 200 Finding Aids section of the printed volume grams. and at www.fdsys.gov. (A) Indications for use. For the pre- 2. At 81 FR 95013, Dec. 27, 2016, § 558.550 was vention of coccidiosis caused by Eimeria amended in part by revising paragraph (d)(4); tenella, E. necatrix, E. acervulina, E. however, the amendment could not be incor- maxima, E. brunetti, and E. mivati, and porated because no revised text for (d)(4) was as an aid in the control of necrotic en- set out. teritis caused or complicated by Clos- tridium spp. or other organisms suscep- § 558.555 Semduramicin. tible to bacitracin. (a) Specifications. Type A medicated (B) Limitations. Feed continuously as article containing: sole ration. To control necrotic enter- (1) 22.7 grams (g) per pound (lb) (50 g/ itis, start medication at first clinical kilogram (kg)) semduramicin (as signs of disease; vary dosage based on semduramicin sodium). the severity of infection; administer (2) 22.7 g/lb (50 g/kg) semduramicin continuously for 5 to 7 days or as long (as semduramicin sodium biomass). as clinical signs persist, then reduce (b) Approvals. See No. 066104 in bacitracin to prevention level (50 § 510.600(c) of this chapter for use of grams per ton). Discontinue use prior product described in paragraph (a)(1) as to sexual maturity. Do not feed to lay- in paragraph (d) of this section; for use

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of product described in paragraph (a)(2) (d) Conditions of use in chickens. It is as in paragraph (e) of this section. used in chicken feed as follows: (c) Related tolerances. See § 556.597 of this chapter.

Combinations Semduramicin in grams per in grams per Indications for use Limitations Sponsor ton ton

(1) 22.7 (25 ppm) Broiler chickens: For the pre- Do not feed to laying hens. 066104 vention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/E. mitis, E. necatrix, and E. tenella.

(2) 22.7 Bacitracin Broiler chickens: As in para- Feed continuously as sole ration. 066104 methylenedi- graph (d)(1) of this section; Do not feed to laying hens. salicylate 10 for improved feed effi- Bacitracin to 50 ciency. methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter.

(e) Conditions of use in chickens. It is used in chicken feed as follows:

Semduramicin in grams per Combination in ton grams per ton Indications for use Limitations Sponsor

(1) 22.7 (25 ppm) Broiler chickens: For the pre- Do not feed to laying hens. 066104 vention of coccidiosis caused by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, and E. mitis. (2) [Reserved]

(f) Semduramycin may also be used graphs (e)(1), (e)(2), (e)(3), (e)(4), and in combination with virginiamycin as (e)(7) of this section. in § 558.635. (2) No. 015331 for use of the product described in paragraph (a)(2) as in para- [59 FR 17477, Apr. 13, 1994, as amended at 60 FR 57928, Nov. 24, 1995; 61 FR 29481, June 11, graphs (e)(5) and (e)(6) of this section. 1996; 61 FR 43451, Aug. 23, 1996; 61 FR 66584, (c) Related tolerances. See §§ 556.490 Dec. 18, 1996; 62 FR 66985, Dec. 23, 1997; 64 FR and 556.640 of this chapter. 48296, Sept. 3, 1999; 66 FR 47964, Sept. 17, 2001; (d) Special considerations. (1) Federal 69 FR 13221, Mar. 22, 2004; 70 FR 41961, July law restricts medicated feed containing 21, 2005; 73 FR 812, Jan. 4, 2008; 74 FR 41631, this veterinary feed directive (VFD) Aug. 18, 2009; 79 FR 10983, Feb. 27, 2014; 79 FR drug to use by or on the order of a li- 13546, Mar. 11, 2014; 81 FR 17609, Mar. 30, 2016; censed veterinarian. See § 558.6 for addi- 81 FR 95013, Dec. 27, 2016] tional requirements. (2) The expiration date of VFDs for § 558.575 Sulfadimethoxine and ormetoprim. sulfadimethoxine and ormetoprim medicated feeds must not exceed 6 (a) Specifications. Type A medicated months from the date of issuance. articles containing either: VFDs for sulfadimethoxine and (1) 25 percent sulfadimethoxine and 15 ormetoprim shall not be refilled. percent ormetoprim; or (e) Conditions of use. It is used in (2) 25 percent sulfadimethoxine and 5 feeds for animals as follows: percent ormetoprim. (1) Broiler chickens—(i) Amount per (b) Sponsors. See sponsors in ton. Sulfadimethoxine, 113.5 grams § 510.600(c) of this chapter for use as in (0.0125 percent) plus ormetoprim, 68.1 paragraph (d) of this section: grams (0.0075 percent). (1) No. 054771 for use of the product (a) Indications for use. As an aid in described in paragraph (a)(1) as in para- the prevention of coccidiosis caused by

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all Eimeria species known to be patho- (a) Indications for use. As an aid in genic to chickens, namely, E. tenella, E. the control of bacterial infections due necatrix, E. acervulina, E. brunetti, E. to E. coli, Riemerella anatipestifer, and mivati, and E. maxima, and bacterial in- severe challenge of P. multocida (fowl fections due to H. gallinarum (infec- cholera) in ducks. tious coryza), E. coli (colibacillosis) and (b) Limitations. Feed as a sole ration P. multocida (fowl cholera). for 7 days; withdraw 5 days before (b) Limitations. Feed as sole ration; slaughter; medication should be start- withdraw 5 days before slaughter. ed at the first signs of infection; not (ii) [Reserved] for breeding ducks; do not feed to (2) Replacement chickens—(i) Amount ducks producing eggs for food. per ton. Sulfadimethoxine, 113.5 grams (5) Salmonids—(i) Amount. 50 milli- (0.0125 percent) plus ormetoprim, 68.1 grams of active ingredients per kilograms (0.0075 percent). gram of body weight per day. (ii) Indications of use. For the control (ii) Indications for use. As an aid in of furunculosis in salmonids (trout and the prevention of coccidiosis caused by salmon) caused by Aeromonas all Eimeria species known to be patho- salmonicida strains susceptible to genic to chickens, namely E. tenella, E. sulfadimethoxine and ormetoprim com- necatrix, E. acervulina, E. brunetti, E. bination. mivati, and E. maxima, and bacterial in- (iii) Limitations. Administer for 5 con- fections due to H. gallinarum (infec- secutive days; withdraw 42 days before tious coryza), E. coli (colibacillosis) and release as stocker fish or slaughter. P. multocida (fowl cholera). (6) Catfish—(i) Amount. 50 milligrams (iii) Limitations. Feed as a sole ration; of active ingredients per kilogram of do not feed to chickens over 16 weeks body weight per day. (112 days) of age; withdraw 5 days be- (ii) Indications for use. For control of fore slaughter. enteric septicemia of catfish caused by (3) Turkeys—(i) Amount per ton. Edwardsiella ictaluri strains susceptible Sulfadimethoxine, 56.75 grams (0.00625 to sulfadimethoxine and ormetoprim percent) plus ormetoprim, 34.05 grams combination. (0.00375 percent). (iii) Limitations. Administer for 5 con- (ii) Indications for use. As an aid in secutive days; withdraw 3 days before the prevention of coccidiosis caused by slaughter or release as stocker fish. all Eimeria species known to be patho- (7) Chukar partridges—(i) Amount per genic to turkeys, namely, E. ton. Sulfadimethoxine 113.5 grams adenoeides, E. gallopavonis, and E. (0.0125 percent) plus ormetoprim 68.1 meleagrimitis and bacterial infection grams (0.0075 percent). due to P. multocida (fowl cholera). (ii) Indications for use. For prevention (iii) Limitations. Do not feed to tur- of coccidiosis caused by Eimeria kofoidi keys producing eggs for food; withdraw and E. legionensis. 5 days before slaughter. (iii) Limitations. Feed continuously to (4) Ducks—(i) Amount per ton. young birds up to 8 weeks of age as sole Sulfadimethoxine, 227 grams (0.025 per- ration. cent) plus ormetoprim, 136.2 grams [40 FR 13959, Mar. 27, 1975, as amended at 42 (0.015 percent). FR 13550, Mar. 11, 1977; 49 FR 33442, Aug. 23, (a) Indications for use. As an aid in 1984; 49 FR 46371, Nov. 26, 1984; 51 FR 7400, the control of bacterial infections due Mar. 3, 1986; 51 FR 18884, May 23, 1986; 52 FR to P. multocida (fowl cholera) in ducks, 2686, Jan. 26, 1987; 54 FR 1686, Jan. 17, 1989; 63 including breeding ducks. FR 27846, May 21, 1998; 64 FR 26672, May 17, 1999; 64 FR 43910, Aug. 12, 1999; 66 FR 46707, (b) Limitations. Feed as sole ration for Sept. 7, 2001; 70 FR 52292, Sept. 2, 2005; 79 FR 7 days; withdraw 5 days before slaugh- 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, 2014; ter; medication should be started at 81 FR 95013, Dec. 27, 2016; 83 FR 13637, Mar. 30, the first signs of infection; do not feed 2018] to ducks producing eggs for food. (ii) Amount per ton. § 558.582 Sulfamerazine. Sulfadimethoxine, 454 grams (0.05 per- (a) Specifications. Type A medicated cent) plus ormetoprim, 272.4 grams (0.03 articles containing 99 percent sulfa- percent). merazine.

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(b) Sponsor. See No. 054771 in censed veterinarian. See § 558.6 for addi- § 510.600(c) of this chapter. tional requirements. (c) Related tolerances. See § 556.660 of (2) The expiration date of VFDs for this chapter. sulfamerazine medicated feeds must (d) Special considerations. (1) Federal not exceed 6 months from the date of law restricts medicated feed containing issuance. VFDs for sulfamerazine shall this veterinary feed directive (VFD) not be refilled. drug to use by or on the order of a li- (e) Conditions of use. It is used in fish feed for as follows:

Sulfamerazine Combination in grams/ton grams/ton Indications for use Limitations Sponsor

(1) To deliver 10 ...... Rainbow trout, brook trout, and Formulate to deliver 10 grams of 054771 grams of sulfa- brown trout: For control of fu- sulfamerazine per 100 pounds merazine per runculosis. of fish per day. Treat for not 100 pounds of more than 14 days. Do not fish per day. treat within 3 weeks of marketing or stocking in stream open to fishing. (2) [Reserved].

[81 FR 95013, Dec. 27, 2016]

§ 558.586 Sulfaquinoxaline. this veterinary feed directive (VFD) (a) Specifications. Type A medicated drug to use by or on the order of a li- articles containing 40 percent censed veterinarian. See § 558.6 for addi- sulfaquinoxaline. tional requirements. (b) Sponsor. See No. 016592 in (2) The expiration date of VFDs for § 510.600(c) of this chapter. sulfaquinoxaline medicated feeds must (c) Related tolerances. See § 556.685 of not exceed 6 months from the date of this chapter. issuance. VFDs for sulfaquinoxaline (d) Special considerations. (1) Federal shall not be refilled. law restricts medicated feed containing (e) Conditions of use—(1) Chickens—

Sulfaquinoxaline Combination in in grams/ton grams/ton Indications for use Limitations Sponsor

(i) 0.015 percent ...... As an aid in preventing out- Feed continuously from the time 016592 breaks of coccidiosis caused birds are placed on litter and by Eimeria tenella, E. necatrix, continue past the age when E. acervulina, E. maxima, and coccidiosis is ordinarily a haz- E. brunetti under average con- ard. If death losses exceed ditions of exposure. 0.5 percent in a 2-day period, obtain a laboratory diagnosis. If coccidiosis is the cause, use the sulfaquinoxaline levels recommended for control of outbreaks, returning to the original dosage schedule after the outbreak has subsided. Losses may result from inter- current disease, other conditions affecting drug intake, or variant strains of coccidia species which can contribute to the virulence of coccidiosis under field conditions. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption.

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Sulfaquinoxaline Combination in in grams/ton grams/ton Indications for use Limitations Sponsor

(ii) 0.0175 percent ...... As an aid in preventing out- Feed continuously from the time 016592 breaks of coccidiosis caused birds are placed on litter and by Eimeria tenella, E. necatrix, continue past the age when E. acervulina, E. maxima, and coccidiosis is ordinarily a haz- E. brunetti where excessive ard. If death losses exceed exposure to coccidia is in- 0.5 percent in a 2-day period, creased due to overcrowding obtain a laboratory diagnosis. or other management factors. If coccidiosis is the cause, use the sulfaquinoxaline levels recommended for control of outbreaks, returning to the original dosage schedule after the outbreak has subsided. Losses may result from inter- current disease, other conditions affecting drug intake, or variant strains of coccidia species which can contribute to the virulence of coccidiosis under field conditions. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption. (iii) 0.1 to 0.05 ...... As an aid in controlling out- Feed at 0.1 percent level for first 016592 percent. breaks of coccidiosis caused 48 to 72 hours. Skip 3 days; by Eimeria tenella, E. necatrix, 0.05 percent for 2 days, skip 3 E. acervulina, E. maxima, and days; 0.05 percent for 2 days. E. brunetti. If bloody droppings recur, give 0.05 percent for another 2 days. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption. (iv) 0.05 or 0.1 ...... As an aid in the control of acute Feed 0.1 percent for 48 to 72 016592 percent. fowl cholera caused by hours. Mortality should be Pasteurella multocida suscep- brought under control. After tible to sulfaquinoxaline and medication, move birds to fowl typhoid caused by Sal- clean ground or to a clean monella gallinarum suscep- house. If disease recurs, use tible to sulfaquinoxaline. 0.05 percent in feed again for 2 days. Do not treat chickens or turkeys within 10 days of slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption.

(2) Turkeys—

Sulfaquinoxaline Combination in in grams/ton grams/ton Indications for use Limitations Sponsor

(i) 0.0175 percent ...... As an aid in preventing out- Feed continuously during time 016592 breaks of coccidiosis caused birds are closely confined. by Eimeria meleagrimitis and May be continued for a week E. adenoeides. to 10 days after flock is transferred to range to reduce danger of an outbreak following moving of the flock. Do not treat turkeys within 10 days of slaughter. Do not medicate turkeys producing eggs for human consumption.

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Sulfaquinoxaline Combination in in grams/ton grams/ton Indications for use Limitations Sponsor

(ii) 0.05 percent...... As an aid in controlling out- Feed for 2 days. Follow with 3 016592 breaks of coccidiosis caused days on regular feed and 2 by Eimeria meleagrimitis and more days on 0.05 percent E. adenoeides. sulfaquinoxaline feed. Again follow with 3 days on regular feed and 2 more days on 0.05 percent sulfaquinoxaline feed. Continue this schedule if necessary until all signs of the outbreaks have subsided. Do not treat turkeys within 10 days of slaughter. Do not medicate turkeys producing eggs for human consumption. (iii) 0.05 or 0.1 ...... As an aid in the control of acute Feed 0.1 percent for 48 to 72 016592 percent. fowl cholera caused by hours. Mortality should be Pasteurella multocida suscep- brought under control. After tible to sulfaquinoxaline and medication, move birds to fowl typhoid caused by Sal- clean ground or to a clean monella gallinarum suscep- house. If disease recurs, use tible to sulfaquinoxaline. 0.05 percent in feed again for 2 days. Do not treat chickens or turkeys within 10 days of slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption.

(3) Rabbits—

Sulfaquinoxaline Combination in in grams/ton grams/ton Indications for use Limitations Sponsor

(i) 0.025 percent ...... As an aid in preventing coccidi- Treatment to be started after 016592 osis caused by Eimeria weaning. Feed continuously stiedae. for 30 days or feed medicated feed for 2 days out of every week until marketing. Do not treat within 10 days of slaughter. (ii) 0.1 percent...... As an aid in controlling out- Feed for 2 weeks. Do not treat 016592 breaks of coccidiosis caused within 10 days of slaughter. by Eimeria stiedae.

[81 FR 95013, Dec. 27, 2016]

§ 558.600 Thiabendazole. (d) Conditions of use. It is used in feed for animals as follows: (a) Approvals. Dry Type A medicated (1) Cattle—(i) Amount. 3 grams per 100 articles: 22, 44.1, 66.1, and 88.2 percent lb. body weight. to 050604 in § 510.600(c) of this chapter. (a) Indications for use. Control of in- The 66.1 percent Type A is solely for fections of gastrointestinal the manufacture of cane molasses liq- roundworms (Trichostrongylus spp., uid Type B feed which is mixed in dry Haemonchus spp., Ostertagia spp., feeds. The 88.2 percent Type A is used Nematodirus spp., Oesophagostomum solely for the manufacture of an aque- radiatum). ous slurry for adding to a Type C dry (b) Limitations. Use 3 grams per 100 lb. cattle feed. body weight at a single dose; may re- (b) Special considerations. Do not use peat once in 2 to 3 weeks; do not treat in Type B or Type C medicated feed animals within 3 days of slaughter; containing bentonite. milk taken from treated animals with- (c) Related tolerances. See § 556.730 of in 96 hours (8 milkings) after the latest this chapter. treatment must not be used for food.

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(ii) Amount. 5 grams per 100 lb. body within 96 hours (8 milkings) after the weight. latest treatment must not be used for (a) Indications for use. Control of se- food. vere infections of gastrointestinal (4) For swine—(i) Amount. 45.4–908 roundworms (Trichostrongylus spp., grams per ton (0.005–0.1 percent). Haemonchus spp., Ostertagia spp., (ii) Indications for use. Aid in the pre- Nematodirus spp., Oesophagostomum vention of infections of large radiatum); control of infections of roundworms (genus Ascaris). Cooperia spp. (iii) Limitations. Administer continu- (b) Limitations. 5 grams per 100 lb. ously feed containing 0.05–0.1 percent body weight at a single dose or divided thiabendazole per ton for 2 weeks fol- into 3 equal doses, administered 1 dose lowed by feed containing 0.005–0.02 per- each day, on succeeding days; may re- cent thiabendazole per ton for 8–14 peat once in 2 to 3 weeks; do not treat weeks; do not treat animals within 30 animals within 3 days of slaughter; days of slaughter. milk taken from treated animals with- (5) Pheasants—(i) Amount. 454 grams in 96 hours (8 milkings) after the latest per ton (0.05 percent) continuously for 2 treatment must not be used for food. weeks (14 days). (2) Goats—(i) Amount. 3 grams per 100 (ii) Indications for use. For the treat- lb. body weight. ment of gapeworms (Syngamus trachea) (ii) Indications for use. Control of sein pheasants. vere infections of gastrointestinal (iii) Limitations. Do not use treated roundworms (Trichostrongylus spp., pheasants for food for 21 days after last Haemonchus spp., Ostertagia spp., day of treatment. Fertility, hatch- Cooperia spp., Nematodirus spp., ability, and other reproductive data Bunostomum spp., Strongyloides spp., are not available on use in breeding Chabertia spp., and Oesophagostomum animals. spp.). [40 FR 13959, Mar. 27, 1975, as amended at 47 (iii) Limitations. 3 grams per 100 lb. FR 49641, Nov. 2, 1982; 49 FR 29958, July 25, body weight at a single dose; do not 1984; 51 FR 7400, Mar. 3, 1986; 52 FR 2686, Jan. treat animals within 30 days of slaugh- 26, 1987; 62 FR 63271, Nov. 28, 1997. Redesig- ter; milk taken from treated animals nated at 80 FR 13232, Mar. 13, 2015] within 96 hours (8 milkings) after the latest treatment must not be used for § 558.612 Tiamulin. food. (a) Specifications. Type A article con- (3) Sheep and goats—(i) Amount. 2 taining 363.2 grams of tiamulin hydro- grams per 100 lb. body weight. gen fumarate per pound. (ii) Indications for use. Control of in- (b) Approvals. See No. 058198 in fections of gastrointestinal § 510.600(c) of this chapter. roundworms (Trichostrongylus spp., (c) Related tolerances. See § 556.732 of Haemonchus spp., Ostertagia spp., this chapter. Cooperia spp.; Nematodirus spp., (d) Special considerations—(1) Swine Bunostomum spp., Strongyloides spp., being treated with tiamulin should not Chabertia spp., and Oesophagostomum have access to feeds containing spp.); also active against ova and lar- polyether ionophores (e.g., lasalocid, vae passed by sheep from 3 hours to 3 monensin, narasin, salinomycin, or days after the feed is consumed (good semduramycin) as adverse reactions activity against ova and larvae of T. may occur. If signs of toxicity occur, colubriformis and axei, Ostertagia spp., discontinue use. Nematodirus spp., Strongyloides spp.; less (2) The effects of tiamulin on swine effective against those of Haemonchus reproductive performance, pregnancy, contortus and Oesophagostomum spp.). and lactation have not been deter- (iii) Limitations. Use 2 grams per 100 mined. lb. body weight at a single dose; do not (3) Use as sole source of tiamulin. treat animals within 30 days of slaugh- (e) Conditions of use—(1) Swine. It is ter; milk taken from treated animals used as follows:

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Tiamulin hydrogen fumarate in Combination in grams per Indications for use Limitations Sponsor grams per ton ton

(i) 35 ...... 1. For control of swine dysentery Feed continuously as sole ra- 058198 associated with Brachyspira (for- tion on premises with a merly Serpulina or Treponema) history of swine dysentery hyodysenteriae susceptible to but where signs of disease tiamulin. have not yet occurred or following approved treatment of disease. Withdraw 2 days before slaughter. 2. For control of porcine prolif- Feed continuously as the 058198 erative enteropathies (ileitis) as- sole ration for not less than sociated with Lawsonia 10 days. Withdraw 2 days intracellularis. before slaughter. (ii) 200 ...... For treatment of swine dysentery Feed continuously as the 058198 associated with Brachyspira (for- sole feed for 14 consecu- merly Serpulina or Treponema) tive days. Withdraw feed 7 hyodysenteriae susceptible to days before slaughter. tiamulin.

(2) Tiamulin may also be used in (ii) Labeling of tilmicosin Type B or combination with chlortetracycline as Type C medicated feeds for swine must in § 558.128. bear the following warning: ‘‘Do not use in any feeds containing bentonite. [67 FR 7268, Feb. 19, 2002, as amended at 69 FR 62407, Oct. 26, 2004; 70 FR 75018, Dec. 19, Bentonite in feeds may affect the effi- 2005; 74 FR 6, Jan. 2, 2009; 77 FR 24139, Apr. 23, cacy of tilmicosin.’’ 2012; 79 FR 13546, Mar. 11, 2014. Redesignated (iii) Feed containing tilmicosin shall and amended at 80 FR 13232, Mar. 13, 2015; 81 not be fed to pigs for more than 21 days FR 95015, Dec. 27, 2016] during each phase of production without ceasing administration for reevalu- § 558.618 Tilmicosin. ation of antimicrobial use by a licensed (a) Specifications. Type A medicated veterinarian before reinitiating a fur- article containing 90.7 grams (g) per ther course of therapy with an appro- pound tilmicosin as tilmicosin phos- priate antimicrobial. phate (200 g per kilogram). (5) Special consideration for use of (b) Approvals. See Nos. 016592 and tilmicosin medicated cattle feeds in- 058198 in § 510.600(c) of this chapter. clude the following: (c) Related tolerances. See § 556.735 of (i) The expiration date of VFDs for this chapter. cattle must not exceed 45 days from (d) Special considerations—(1) Federal the time of issuance. law restricts medicated feed containing (ii) Labeling of tilmicosin Type B or this veterinary feed directive (VFD) Type C medicated feeds for cattle must drug to use by or on the order of a li- bear the following warning: ‘‘Do not censed veterinarian. See § 558.6 for addi- use in any feeds containing bentonite, tional requirements. cottonseed meal, or cottonseed hulls. (2) VFDs for tilmicosin phosphate Bentonite, cottonseed meal, or cotton- shall not be refilled. seed hulls in feeds may affect the effi- (3) Labeling of tilmicosin Type B or cacy of tilmicosin.’’ Type C medicated feeds must bear the (iii) To assure both food safety and following warnings: responsible use in cattle, administra- (i) Do not allow horses or other tion of feed containing tilmicosin to equines access to feeds containing cattle experiencing an outbreak of tilmicosin. BRD must be initiated during the first (ii) [Reserved] 45 days of the production period, shall (4) Special considerations for use of not exceed a single 14-consecutive-day tilmicosin medicated swine feeds in- treatment, should not occur concur- clude the following: rent with or following administration (i) The expiration date of VFDs for of an injectable macrolide, and should tilmicosin must not exceed 90 days not occur within 3 days following ad- from the time of issuance. ministration of a nonmacrolide

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injectable BRD therapy. Tilmicosin treatment with an alternative nonmedicated feed treatment has not been macrolide therapy. evaluated in cattle with severe clinical (e) Conditions of use. It is used in feed disease. Cattle with severe clinical ill- as follows: ness should be evaluated for individual (1) Swine—

Tilmicosin phosphate Combination in Indications for use Limitations Sponsor in grams/ton grams/ton

(i) 181 to 363 ...... Swine: For the control of Feed continuously as the sole ration 058198, swine respiratory dis- for 21-day period, beginning ap- 016592 ease associated with proximately 7 days before an antici- Actinobacillus pated disease outbreak. The safety pleuropneumoniae and of tilmicosin has not been estab- Pasteurella multocida. lished in male swine intended for breeding purposes. Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this drug product. (ii) [Reserved] ......

(2) Cattle—

Tilmicosin phosphate Combination in Indications for use Limitations Sponsor in grams/ton grams/ton

(i) 568 to 757 ...... Beef and nonlactating Feed continuously for 14 days to pro- 058198, dairy cattle: For the vide 12.5 mg tilmicosin/kg of body- 016592 control of bovine res- weight/day. The safety of tilmicosin piratory disease has not been established in cattle in- (BRD) associated with tended for breeding purposes. This Mannheimia drug product is not approved for use haemolytica, in female dairy cattle 20 months of Pasteurella multocida, age or older. Use in these cattle may and Histophilus somni cause drug residues in milk. This in groups of beef and drug product is not approved for use nonlactating dairy cat- in calves intended to be processed tle, where active BRD for veal. A withdrawal period has not has been diagnosed been established in preruminating in at least 10 percent calves. Cattle intended for human of the animals in the consumption must not be slaugh- group. tered within 28 days of the last treatment with this drug product. (ii) 568 to 757 ...... Monensin, 5 to 40 ..... Cattle fed in confine- Feed continuously for 14 days to pro- 016952, ment for slaughter: vide 12.5 mg tilmicosin/kg of body- 058198 For improved feed ef- weight/day. The safety of tilmicosin ficiency; and for the has not been established in cattle in- control of bovine res- tended for breeding purposes. This piratory disease drug product is not approved for use (BRD) associated with in female dairy cattle 20 months of Mannheimia age or older. Use in these cattle may haemolytica, cause drug residues in milk. This Pasteurella multocida, drug product is not approved for use and Histophilus somni in calves intended to be processed in groups of cattle fed for veal. A withdrawal period has not in confinement for been established in pre-ruminating slaughter, where ac- calves. Cattle intended for human tive BRD has been di- consumption must not be slaugh- agnosed in at least 10 tered within 28 days of the last treat- percent of the animals ment with this drug product. See in the group. § 558.355(d) of this chapter. Tilmicosin as provided by Nos. 000986 or 016952; monensin as provided by No. 000986 in § 510.600(c) of this chapter..

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Tilmicosin phosphate Combination in Indications for use Limitations Sponsor in grams/ton grams/ton

(iii) 568 to 757 ...... Monensin, 10 to 40 ... Cattle fed in confine- Feed continuously for 14 days to pro- 016952, ment for slaughter: vide 12.5 mg tilmicosin/kg of body- 058198 For prevention and weight/day. The safety of tilmicosin control of coccidiosis has not been established in cattle in- due to Eimeria bovis tended for breeding purposes. This and E. zuernii; and for drug product is not approved for use the control of bovine in female dairy cattle 20 months of respiratory disease age or older. Use in these cattle may (BRD) associated with cause drug residues in milk. This Mannheimia drug product is not approved for use haemolytica, in calves intended to be processed Pasteurella multocida, for veal. A withdrawal period has not and Histophilus somni been established in pre-ruminating in groups of cattle fed calves. Cattle intended for human in confinement for consumption must not be slaugh- slaughter, where ac- tered within 28 days of the last treat- tive BRD has been di- ment with this drug product. See agnosed in at least 10 § 558.355(d) of this chapter. percent of the animals Tilmicosin as provided by Nos. in the group. 000986 or 016952; monensin as provided by No. 000986 in § 510.600(c) of this chapter..

[61 FR 68148, Dec. 27, 1996; 62 FR 15391, Apr. 1, issuance. VFDs for tylosin shall not be 1997, as amended at 64 FR 13679, Mar. 22, 1999; refilled. 65 FR 76930, Dec. 8, 2000; 67 FR 21997, May 2, (3) Type C medicated feeds for cattle 2002; 69 FR 78306, Dec. 30, 2004; 76 FR 76894, may be manufactured from tylosin liq- Dec. 9, 2011; 77 FR 60623, Oct. 4, 2012; 78 FR 19987, Apr. 3, 2013; 80 FR 61298, Oct. 13, 2015; uid Type B medicated feeds which have 80 FR 76387, Dec. 9, 2015; 81 FR 48703, July 26, a pH between 4.5 and 6.0 and which bear 2016; 81 FR 59135, Aug. 29, 2016; 81 FR 67153, appropriate mixing directions as fol- Sept. 30, 2016] lows: (i) For liquid feeds stored in recircu- § 558.625 Tylosin. lating tank systems: Recirculate im- (a) Specifications. Type A medicated mediately prior to use for not less than articles containing tylosin phosphate. 10 minutes, moving not less than 1 per- (b) Sponsors. See sponsor numbers in cent of the tank contents per minute § 510.600(c) of this chapter. from the bottom of the tank to the top. (1) No. 016592: Type medicated article Recirculate daily as described even containing 100 grams per pound. when not used. (2) No. 054771: Type medicated article (ii) For liquid feeds stored in me- containing 40 grams per pound. chanical, air, or other agitation-type (3) No. 058198: Type medicated article tank systems: Agitate immediately containing 10, 40, or 100 grams per prior to use for not less than 10 min- pound. utes, creating a turbulence at the bot- (4) No. 066104: Type medicated article tom of the tank that is visible at the containing 20 or 40 grams per pound. top. Agitate daily as described even (c) Related tolerances. See § 556.740 of when not used. this chapter. (4) Tylosin liquid Type B medicated (d) Special considerations. (1) Federal feeds must bear an expiration date of 31 law restricts medicated feed containing days after the date of manufacture. this veterinary feed directive (VFD) (5) Do not use tylosin liquid Type B drug to use by or on the order of a li- medicated feeds in any liquid feed con- censed veterinarian. See § 558.6 for addi- taining sodium metabisulfite or in any tional requirements. finished feed (supplement, concentrate, (2) The expiration date of VFDs for or complete feed) containing in excess tylosin medicated feeds must not ex- of 2 percent bentonite. ceed 6 months from the date of (e) Conditions of use—(1) Swine—

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Tylosin Combination in grams/ton grams/ton Indications for use Limitations Sponsors

(i) 40 or 100 ...... For control of swine dysentery Feed as the sole ration 100 g of 016592 associated with Brachyspira tylosin per ton of complete 054771 hyodysenteriae. feed for at least 3 weeks. Fol- 058198 low with 40 grams per ton of 066104 complete feed until market weight. (ii) 40 or 100 ...... Pyrantel, 96 ...... For control of swine dysentery Feed as the sole ration 100 g of 066104 associated with Brachyspira tylosin per ton of complete hyodysenteriae; and as an aid feed for at least 3 weeks. Fol- in the prevention of migration low with 40 grams per ton of and establishment of large complete feed until market roundworm (Ascaris suum) in- weight. Tylosin phosphate and fections; aid in the prevention pyrantel as provided by No. of establishment of nodular 066104 in § 510.600(c) of this worm (Oesophagostomum chapter. spp.) infections. (iii) 40 or 100...... For control of porcine prolif- Feed as the sole ration 100 g of 016592 erative enteropathies (ileitis) tylosin per ton of complete 054771 associated with Lawsonia feed for at least 3 weeks. Fol- 058198 intracellularis. low with 40 grams per ton of 066104 complete feed until market weight. (iv) 40 or 100 ...... Pyrantel, 96 ...... For control of porcine prolif- Feed as the sole ration 100 g of 066104 erative enteropathies (ileitis) tylosin per ton of complete associated with Lawsonia feed for at least 3 weeks. Fol- intracellularis; and as an aid in low with 40 grams per ton of the prevention of migration complete feed until market and establishment of large weight. Tylosin phosphate and roundworm (Ascaris suum) in- pyrantel as provided by No. fections; aid in the prevention 066104 in § 510.600(c) of this of establishment of nodular chapter. worm (Oesophagostomum spp.) infections. (v) 40 or 100 ...... Ractopamine, 4.5 to Finishing swine: For the control Feed continuously as the sole 016592 9.0. of swine dysentery associated ration to finishing swine 054771 with Brachyspira weighing not less than 150 lbs 058198 hyodysenteriae; for control of for the last 45 to 90 lbs (group porcine proliferative average) of weight gain prior enteropathies (ileitis) associ- to slaughter. Include 100 g/ton ated with Lawsonia of tylosin for at least 3 weeks, intracellularis; and for in- followed by 40 g/ton until mar- creased rate of weight gain, ket weight. Tylosin phosphate improved feed efficiency, and as provided by Nos. 058198 increased carcass leanness in and 016592; ractopamine as finishing swine weighing not provided by Nos. 058198 and less than 150 lbs, fed a com- 054771 in § 510.600(c) of this plete ration containing at least chapter. 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter. (vi) 40 to 100 ...... For the treatment and control of Administer as tylosin phosphate 016592 swine dysentery associated in feed continuously as the 054771 with Brachyspira sole ration for 2 to 6 weeks, 058198 hyodysenteriae immediately immediately after treatment 066104 after medicating with tylosin in with tylosin tartrate in drinking drinking water. water for 3 to 10 days as in § 520.2640(d)(3) of this chapter. (vii) 40 or 100 ..... Pyrantel, 96 ...... For the treatment and control of Administer as tylosin phosphate 066104 swine dysentery associated in feed continuously as the with Brachyspira sole ration for 2 to 6 weeks, hyodysenteriae immediately immediately after treatment after medicating with tylosin in with tylosin tartrate in drinking drinking water; and as an aid water for 3 to 10 days as in in the prevention of migration § 520.2640(d)(3) of this chap- and establishment of large ter. Tylosin phosphate and roundworm (Ascaris suum) in- pyrantel as provided by No. fections; aid in the prevention 066104 in § 510.600(c) of this of establishment of nodular chapter. worm (Oesophagostomum spp.) infections.

505

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Tylosin Combination in grams/ton grams/ton Indications for use Limitations Sponsors

(viii) 40 to 100 ...... For the control of porcine prolif- Administer as tylosin phosphate 016592 erative enteropathies (PPE, il- in feed continuously as the 054771 eitis) associated with sole ration for 2 to 6 weeks, 058198 Lawsonia intracellularis imme- immediately after treatment 066104 diately after medicating with with tylosin tartrate in drinking tylosin in drinking water. water for 3 to 10 days as in § 520.2640(d)(3) of this chapter. (ix) 40 or 100 ...... Pyrantel, 96 ...... For the control of porcine prolif- Administer as tylosin phosphate 066104 erative enteropathies (PPE, il- in feed continuously as the eitis) associated with sole ration for 2 to 6 weeks, Lawsonia intracellularis imme- immediately after treatment diately after medicating with with tylosin tartrate in drinking tylosin in drinking water; and water for 3 to 10 days as in as an aid in the prevention of § 520.2640(d)(3) of this chap- migration and establishment ter. Tylosin phosphate and of large roundworm (Ascaris pyrantel as provided by No. suum) infections; aid in the 066104 in § 510.600(c) of this prevention of establishment of chapter. nodular worm (Oesophagostomum spp.) infections. (x) 40 to 100 ...... Ractopamine, 4.5 to Finishing swine: For the treat- Feed continuously as the sole 016592 9.0. ment and control of swine ration to finishing swine 054771 dysentery associated with weighing not less than 150 lbs 058198 Brachyspira hyodysenteriae, for the last 45 to 90 lbs (group for control of porcine prolif- average) of weight gain prior erative enteropathies (PPE, il- to slaughter. Include 40 to 100 eitis) associated with grams of tylosin phosphate Lawsonia intracellularis; and per ton of complete feed for 2 for increased rate of weight to 6 weeks, immediately after gain, improved feed efficiency, treatment with tylosin tartrate and increased carcass lean- in drinking water for 3 to 10 ness in finishing swine weigh- days as in § 520.2640(d)(3) of ing not less than 150 lbs, fed this chapter. Tylosin phos- a complete ration containing phate as provided by Nos. at least 16% crude protein for 058198 and 016592; the last 45 to 90 lbs of gain ractopamine as provided by prior to slaughter. Nos. 058198 and 054771 in § 510.600(c) of this chapter. (xi) 100 ...... For reduction in severity of ef- Feed continuously as the sole 016592 fects of atrophic rhinitis. ration. 054771 058198 066104 (xii) 100 ...... Pyrantel, 96 ...... For reduction in severity of ef- Feed continuously as the sole 066104 fects of atrophic rhinitis; aid as ration. Tylosin phosphate and an aid in the prevention of mi- pyrantel as provided by No. gration and establishment of 066104 in § 510.600(c) of this large roundworm (Ascaris chapter. Tylosin phosphate suum) infections; aid in the and pyrantel as provided by prevention of establishment of No. 066104 in § 510.600(c) of nodular worm this chapter. (Oesophagostomum spp.) infections. (xiii) 100 ...... Ractopamine, 4.5 to For the control of porcine prolif- Feed continuously as the sole 016592 9.0. erative enteropathies (PPE, il- ration to finishing swine 054771 eitis) associated with weighing not less than 150 lbs 058198 Lawsonia intracellularis; and for the last 45 to 90 lbs (group for increased rate of weight average) of weight gain prior gain, improved feed efficiency, to slaughter. Include 100 g/ton and increased carcass lean- of tylosin for 3 weeks. Tylosin ness in finishing swine weigh- phosphate as provided by ing not less than 150 lbs, fed Nos. 058198 and 016592; a complete ration containing ractopamine as provided by at least 16% crude protein for Nos. 058198 and 054771 in the last 45 to 90 lbs of gain § 510.600(c) of this chapter. prior to slaughter.

(2) Cattle—

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Tylosin Combination in grams/ton grams/ton Indications for use Limitations Sponsors

(i) 8 to 10 ...... Beef cattle: For reduction of inci- Feed continuously as the sole 016592, dence of liver abscesses ration to provide 60 to 90 mg/ 054771, caused by Fusobacterium head/day tylosin. 058198, necrophorum and 066104 Arcanobacterium (Actinomyces) pyogenes. (ii) 90 to 360 ...... Lasalocid, 100 to Heifers fed in confinement for Feed continuously as sole ra- 054771 1440 plus slaughter: For reduction of in- tion. Feed to heifers at the 016592 melengestrol, cidence of liver abscesses rate of 0.5 to 2.0 pound(s) per 0.25 to 2.0. caused by Fusobacterium head per day (specify one necrophorum and level) to provide 0.25 to 0.5 Arcanobacterium pyogenes; mg melengestrol acetate per and for increased rate of head per day (specify one weight gain, improved feed ef- level), 100 to 360 mg ficiency, and suppression of lasalocid per head per day estrus (heat). (specify one level), and 90 mg tylosin per head per day. This Type C product may be top dressed onto or mixed into a complete feed prior to feeding. Tylosin as provided by Nos. 058198 and 016592; lasalocid as provided by No. 054771; melengestrol as provided by Nos. 054771 and 058198 in § 510.600(c) of this chapter. See §§ 558.311(d) and 558.342(d) in this chapter. (iii) 90 to 360 ...... Melengestrol, 0.25 Heifers fed in confinement for Feed continuously as sole ra- 054771 to 2.0. slaughter: For reduction of in- tion. Each pound contains cidence of liver abscesses 0.125 to 1.0 mg melengestrol caused by Fusobacterium acetate and 45 to 180 mg of necrophorum and tylosin. Feed to heifers at a Arcanobacterium pyogenes; rate of 0.5 to 2.0 pounds per and for increased rate of head per day to provide 0.25 weight gain, improved feed ef- to 0.5 mg melengestrol ace- ficiency, and suppression of tate and 60 to 90 mg tylosin estrus (heat). per head per day. Prior to feeding, this Type C product must be top-dressed onto a complete feed or mixed into the amount of complete feed consumed by an animal per day. Tylosin provided by No. 058198; melengestrol provided by No. 054771 in § 510.600(c) of this chapter. See § 558.342(d) in this chapter. (iv) 8 to 10 ...... Monensin, 5 to 40 .. Cattle fed in confinement for Feed continuously as sole ration 016592 slaughter: For reduction of in- to provide 50 to 480 monensin 058198 cidence of liver abscesses mg/head/day and 60 to 90 caused by Fusobacterium mg/head/day tylosin. A with- necrophorum and drawal time has not been es- Arcanobacterium tablished for pre-ruminating (Actinomyces) pyogenes; and calves. Do not use in calves for improved feed efficiency. to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198 in § 510.600(c) of this chapter. See § 558.355(d) in this chapter.

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Tylosin Combination in grams/ton grams/ton Indications for use Limitations Sponsors

(v) 8 to 10 ...... Monensin, 10 to 40 Cattle fed in confinement for Feed continuously as sole ration 016592 slaughter: For reduction of in- to provide 0.14 to 0.42 mg 058198 cidence of liver abscesses monensin/lb body weight per caused by Fusobacterium day, depending on the sever- necrophorum and ity of the coccidiosis chal- Arcanobacterium lenge, up to 480 mg/head/day (Actinomyces) pyogenes; and and 60 to 90 mg/head/day for prevention of coccidiosis tylosin. A withdrawal time has caused by Eimeria bovis and not been established for pre- E zuernii. ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198 in § 510.600(c) of this chapter. See § 558.355(d) in this chapter. (vi) 8 to 10 ...... Monensin, 5 to 30 Cattle fed in confinement for Feed continuously as the sole 016592 plus decoquinate, slaughter: For reduction of in- ration to provide 22.7 mg of 054771 13.6 to 22.7. cidence of liver abscesses decoquinate per 100 lb body caused by Fusobacterium weight per day, 50 to 360 mg necrophorum and of monensin/head/day, and 60 Arcanobacterium pyogenes; to 90 mg of tylosin/head/day. for the prevention of coccidi- Feed at least 28 days during osis caused by Eimeria bovis period of exposure to coccidi- and E. zuernii; and for im- osis or when it is likely to be a proved feed efficiency. hazard. Do not feed to animals producing milk for food. Do not feed to lactating dairy cattle. A withdrawal time has not been established for preruminating calves. Do not use in calves to be processed for veal. Tylosin as provided by Nos. 016592 and 058198; monensin as provided by No. 058198; decoquinate as provided by No. 058198 in § 510.600(c) of this chapter. See §§ 558.311(d) and 558.355(d) in this chapter.

508

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Tylosin Combination in grams/ton grams/ton Indications for use Limitations Sponsors

(vii) 8 to 10 ...... Monensin, 10 to 40 Heifers fed in confinement for Feed continuously as sole ration 016592 plus melengestrol, slaughter: For reduction of in- to heifers at a rate of 0.5 to 054771 0.25 to 2.0. cidence of liver abscesses 2.0 pounds per head per day 058198 caused by Fusobacterium to provide 0.25 to 0.5 mg/ necrophorum and head/day melengestrol ace- Arcanobacterium tate and 0.14 to 0.42 mg (Actinomyces) pyogenes; for monensin/lb body weight per prevention and control of coc- day, depending on the sever- cidiosis caused by Eimeria ity of the coccidiosis chal- bovis and E zuernii; and for lenge, up to 480 mg/head/day increased rate of weight gain, and 60 to 90 mg/head/day improved feed efficiency, and tylosin. The melengestrol ace- suppression of estrus (heat). tate portion of this Type C medicated feed must be mixed into the complete feed containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin at feeding into the amount of complete feed consumed by an animal per day. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; melengestrol provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.342(d) and 558.355(d) in this chapter. (viii) 8 to 10 ...... Monensin, 10 to 40 Cattle fed in confinement for Feed continuously as sole ration 054771 plus ractopamine, slaughter: For reduction of in- to provide 70 to 430 mg/head/ 058198 8.2 to 24.6. cidence of liver abscesses day ractopamine and 0.14 to caused by Fusobacterium 0.42 mg monensin/lb body necrophorum and weight per day, depending on Arcanobacterium pyogenes; the severity of the coccidiosis for prevention and control of challenge, up to 480 mg/head/ coccidiosis caused by Eimeria day and 60 to 90 mg/head/ bovis and E zuernii; and for day tylosin for the last 28 to increased rate of weight gain 42 days on feed. A withdrawal and improved feed efficiency time has not been established in cattle fed in confinement for for pre-ruminating calves. Do slaughter for the last 28 to 42 not use in calves to be proc- days on feed. essed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; ractopamine provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.355(d) and 558.500(d) in this chapter.

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Tylosin Combination in grams/ton grams/ton Indications for use Limitations Sponsors

(ix) 8 to 10 ...... Monensin, 10 to 40 Cattle fed in confinement for Feed a minimum of 1.0 lb/head/ 054771 plus ractopamine, slaughter: For reduction of in- day ractopamine Type C top 058198 not to exceed 800. cidence of liver abscesses dress feed continuously to caused by Fusobacterium cattle fed in confinement for necrophorum and slaughter, to provide 70 to Arcanobacterium pyogenes; 400 mg/head/day ractopamine for prevention and control of for the last 28 to 42 days on coccidiosis caused by Eimeria feed. Feed on top of a ration bovis and E zuernii; and for containing 10 to 40 g/ton increased rate of weight gain monensin and 8 to 10 g/ton and improved feed efficiency tylosin phosphate, to provide in cattle fed in confinement for 0.14 to 0.42 mg monensin/lb slaughter for the last 28 to 42 body weight/day, depending days on feed. on the severity of the coccidiosis challenge, up to 480 mg/ head/day and 60 to 90 mg/ head/day tylosin. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; ractopamine provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.355(d) and 558.500(d) in this chapter. (x) 8 to 10 ...... Monensin 10 to 40 Cattle fed in confinement for Feed continuously as sole ration 054771 plus ractopamine slaughter: For reduction of in- to provide 90 to 430 mg/head/ 058198 9.8 to 24.6. cidence of liver abscesses day ractopamine and 0.14 to caused by Fusobacterium 0.42 mg monensin/lb body necrophorum and weight per day, depending on Arcanobacterium pyogenes; the severity of the coccidiosis for prevention and control of challenge, up to 480 mg/head/ coccidiosis caused by Eimeria day and 60 to 90 mg/head/ bovis and E zuernii; and for day tylosin for the last 28 to increased rate of weight gain, 42 days on feed. A withdrawal improved feed efficiency, and time has not been established increased carcass leanness in for pre-ruminating calves. Do cattle fed in confinement for not use in calves to be proc- slaughter for the last 28 to 42 essed for veal. Tylosin pro- days on feed. vided by Nos. 016592 or 058198; monensin as provided by No. 058198; ractopamine as provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.355(d) and 558.500(d) in this chapter.

510

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Tylosin Combination in grams/ton grams/ton Indications for use Limitations Sponsors

(xi) 8 to 10 ...... Monensin, 10 to 40 Heifers fed in confinement for Feed continuously as sole ration 054771 plus ractopamine, slaughter: For reduction of in- to provide 90 to 430 mg/head/ 058198 9.8 to 24.6 plus cidence of liver abscesses day ractopamine and 0.14 to melengestrol, caused by Fusobacterium 0.42 mg monensin/lb body 0.125 to 1 mg/lb. necrophorum and weight per day, depending on Arcanobacterium the severity of the coccidiosis (Actinomyces) pyogenes; for challenge, up to 480 mg/head/ prevention and control of coc- day and 60 to 90 mg/head/ cidiosis caused by Eimeria day tylosin for the last 28 to bovis and E zuernii; for in- 42 days on feed. Feed creased rate of weight gain, melengestrol as a top dress or improved feed efficiency, and mixed with a complete ration increased carcass leanness; at the rate of 0.5 to 2.0 and suppression of estrus pound/head/day (specify one (heat). level) to provide 0.25 to 0.5 mg melengestrol acetate/ head/day (specify one level). A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; ractopamine as provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.342(d), 558.355(d), and 558.500(d) in this chapter. (xii) 8 to 10 ...... Monensin, 10 to 40 Cattle fed in confinement for Feed continuously as the sole 000061 plus zilpaterol, 6.8. slaughter: For reduction of in- ration to cattle during the last 016592 cidence of liver abscesses 20 to 40 days on feed to pro- caused by Fusobacterium vide 60 to 90 mg/head/day necrophorum and zilpaterol, 0.14 to 0.42 mg/lb Arcanobacterium pyogenes; body weight/day monensin, for prevention and control of depending on the severity of coccidiosis caused by Eimeria the coccidiosis challenge, up bovis and E zuernii; and for to 480 mg/head/day increased rate of weight gain, monensin, and 60 to 90 mg/ improved feed efficiency, and head/day tylosin. Do not use increased carcass leanness in in veal calves. Withdrawal pe- cattle fed in confinement for riod 3 days. Tylosin provided slaughter for the last 20 to 40 by Nos. 016592 or 058198; days on feed. monensin as provided by No. 058198; zilpaterol as provided by No. 000061 in § 510.600(c) of this chapter. See §§ 558.355(d) and 558.665(d) in this chapter. (xiii) 8 to 10 ...... Monensin, 10 to 40 Cattle fed in confinement for Feed this component feed con- 000061 plus zilpaterol, 6.8 slaughter: For reduction of in- tinuously to cattle during the 016592 to 24. cidence of liver abscesses last 20 to 40 days on feed to caused by Fusobacterium provide 60 mg/head/day necrophorum and zilpaterol, 0.14 to 0.42 mg/lb Arcanobacterium pyogenes; body weight/day monensin, for prevention and control of depending on the severity of coccidiosis caused by Eimeria the coccidiosis challenge, up bovis and E zuernii; and for to 480 mg/head/day increased rate of weight gain, monensin, and 60 to 90 mg/ improved feed efficiency, and head/day tylosin. Do not use increased carcass leanness in in veal calves. Withdrawal pe- cattle fed in confinement for riod 3 days. Tylosin provided slaughter for the last 20 to 40 by Nos. 016592 or 058198; days on feed. monensin as provided by No. 058198; zilpaterol as provided by No. 000061 in § 510.600(c) of this chapter. See §§ 558.355(d) and 558.665(d) in this chapter.

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Tylosin Combination in grams/ton grams/ton Indications for use Limitations Sponsors

(xiv) 8 to 10 ...... Monensin, 10 to 40 Heifers fed in confinement for Feed continuously as the sole 000061 plus zilpaterol, 6.8 slaughter: For reduction of in- ration to cattle during the last 016592 plus melengestrol, cidence of liver abscesses 20 to 40 days on feed to pro- 058198 0.125 to 1 mg/lb. caused by Fusobacterium vide 60 to 90 mg/head/day necrophorum and zilpaterol, 0.14 to 0.42 mg/lb Arcanobacterium body weight/day monensin, (Actinomyces) pyogenes; for depending on the severity of prevention and control of coc- the coccidiosis challenge, up cidiosis caused by Eimeria to 480 mg/head/day bovis and E zuernii; and for monensin, and 60 to 90 mg/ increased rate of weight gain, head/day tylosin. Feed improved feed efficiency, and melengestrol as a top dress or increased carcass leanness in mixed with a complete ration cattle fed in confinement for at the rate of 0.5 to 2.0 slaughter for the last 20 to 40 pound/head/day (specify one days on feed; and for sup- level) to provide 0.25 to 0.5 pression of estrus (heat). mg melengestrol acetate/ head/day (specify one level). Do not use in veal calves. Withdrawal period 3 days. Tylosin as provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061; melengestrol provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.342(d), 558.355(d) and 558.665(d) in this chapter. (xv) 8 to 10 ...... Monensin, 10 to 40 Heifers fed in confinement for Feed this component feed con- 000061 plus zilpaterol, 6.8 slaughter: For reduction of in- tinuously to cattle during the 016592 to 24 plus cidence of liver abscesses last 20 to 40 days on feed to 058198 melengestrol, caused by Fusobacterium provide 60 mg/head/day 0.125 to 1 mg/lb. necrophorum and zilpaterol, 0.14 to 0.42 mg/lb Arcanobacterium body weight/day monensin, (Actinomyces) pyogenes; for depending on the severity of prevention and control of coc- the coccidiosis challenge, up cidiosis caused by Eimeria to 480 mg/head/day bovis and E zuernii; and for monensin, and 60 to 90 mg/ increased rate of weight gain, head/day tylosin. Feed improved feed efficiency, and melengestrol as a top dress or increased carcass leanness in mixed with a complete ration cattle fed in confinement for at the rate of 0.5 to 2.0 slaughter for the last 20 to 40 pound/head/day (specify one days on feed; and for sup- level) to provide 0.25 to 0.5 pression of estrus (heat). mg melengestrol acetate/ head/day (specify one level). Do not use in veal calves. Withdrawal period 3 days. Tylosin as provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061; melengestrol provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.342(d), 558.355(d) and 558.665(d) in this chapter.

[40 FR 13959, Mar. 27, 1975] § 558.630 Tylosin and sulfamethazine. EDITORIAL NOTE: For FEDERAL REGISTER ci- (a) Specifications. Type A medicated tations affecting § 558.625, see the List of CFR articles containing equal amounts of Sections Affected, which appears in the tylosin phosphate and sulfamethazine, Finding Aids section of the printed volume and at www.fdsys.gov. available in concentrations of 5, 10, 20, or 40 grams each, per pound.

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(b) Sponsors. See sponsor numbers in censed veterinarian. See § 558.6 for addi- § 510.600(c) of this chapter. tional requirements. (1) No. 058198 for use as in paragraph (2) The expiration date of VFDs for (e)(1) of this section. tylosin and sulfamethazine medicated (2) No. 054771: 10 or 40 grams per feeds must not exceed 6 months from pound each for use as in paragraph the date of issuance. VFDs for tylosin (e)(2) of this section. and sulfamethazine shall not be re- (c) Related tolerances. See §§ 556.670 filled. and 556.740 of this chapter. (3) Labeling shall bear the statement: (d) Special considerations. (1) Federal ‘‘Do not use in medicated feeds con- law restricts medicated feed containing taining in excess of 2% bentonite.’’ this veterinary feed directive (VFD) (e) Conditions of use. It is used in feed drug to use by or on the order of a li- for swine as follows:

Tylosin phosphate and Combination in sulfamethazine grams/ton Indications for use Limitations Sponsors in grams/ton

(1) 100 each ...... For reduction in the severity of Withdraw 15 days before swine 058198 effects of atrophic rhinitis; low- are slaughtered. ering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery associated with Brachyspira hyodysenteriae; control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Arcanobacterium pyogenes); reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci. Only the sulfamethazine portion of this combination is active in controlling jowl abscesses. (2) 100 each ...... For reduction in the severity of Withdraw 15 days before swine 054771 effects of atrophic rhinitis; low- are slaughtered. ering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery associated with Brachyspira hyodysenteriae; and control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Arcanobacterium pyogenes).

[81 FR 95021, Dec. 27, 2016]

§ 558.633 Tylvalosin. censed veterinarian. See § 558.6 for addi- (a) Specifications. Type A medicated tional requirements. articles containing 77.12 grams (2) VFDs for tylvalosin shall not be tylvalosin per pound as tylvalosin tar- refilled. trate. (3) An expiration date of 1 week is re- (b) Sponsor. See No. 066916 in quired for tylvalosin Type C medicated § 510.600(c) of this chapter. swine feeds in pelleted or crumbled (c) Related tolerances. See § 556.748 of form. this chapter. (e) Conditions of use in swine—(1) (d) Special considerations—(1) Federal Amount. Administer 38.6 grams law restricts medicated feed containing tylvalosin per ton of Type C medicated this veterinary feed directive (VFD) feed (42.5 ppm) as the sole ration for 14 drug to use by or on the order of a li- consecutive days.

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(2) Indications for use. For the control (d) Special considerations. (1) Federal of porcine proliferative enteropathy law restricts medicated feed containing (PPE) associated with Lawsonia this veterinary feed directive (VFD) intracellularis infection in groups of drug to use by or on the order of a li- swine in buildings experiencing an out- censed veterinarian. See § 558.6 for addi- break of PPE. tional requirements. (2) The expiration date of VFDs for [81 FR 36790, June 8, 2016, as amended at 81 virginiamycin medicated feeds must FR 67153, Sept. 30, 2016] not exceed 6 months from the date of § 558.635 Virginiamycin. issuance. VFDs for virginiamycin shall not be refilled. (a) Specifications. Type A medicated (3) Not for use in breeding swine over articles containing 10, 20, 50, or 227 120 pounds. grams virginiamycin per pound. (4) Dilute Type A article with at (b) Sponsors. See No. 066104 in least 10 pounds of a feed ingredient § 510.600(c) of this chapter. prior to final mixing in 1 ton of Type C (c) Related tolerances. See § 556.750 of feed. this chapter. (e) Conditions of use—(1) Chickens—

Virginiamycin Combination in grams/ton grams/ton Indications for use Limitations Sponsors

(i) 20 ...... Broiler chickens: For prevention Not for use in layers ...... 066104 of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin. (ii) 20 ...... Amprolium 72.6 to Broiler chickens: For prevention For field conditions where only 066104 113.5. of necrotic enteritis caused by E. tenella is the major prob- Clostridium perfringens sus- lem, feed continuously as the ceptible to virginiamycin; and sole ration. Use as the sole for the prevention of coccidi- source of amprolium. Do not osis caused by Eimeria tenella. use in feeds containing bentonite. Not for use in laying chickens. Amprolium as provided by No. 016592 in § 510.600(c) of this chapter. (iii) 20 ...... Amprolium 113.5 to Broiler chickens: For prevention For most field conditions as they 066104 227. of necrotic enteritis caused by exist under modern manage- Clostridium perfringens sus- ment practices, feed 113.5 g/ ceptible to virginiamycin; and ton amprolium continuously. for the prevention of coccidi- Where severe coccidiosis con- osis where immunity to coc- ditions exist, feed 227 g/ton. cidiosis is not desired. Use as the sole source of amprolium. Do not use in feeds containing bentonite. Not for use in laying chickens. Amprolium as provided by No. 016592 in § 510.600(c) of this chapter. (iv) 20 ...... Diclazuril 0.91 ...... Broiler chickens: For prevention Feed continuously as the sole 016592 of necrotic enteritis caused by ration. Do not use in hens Clostridium perfringens sus- producing eggs for human ceptible to virginiamycin; and food. Diclazuril as provided by for the prevention of coccidi- No. 016592 in § 510.600(c) of osis caused by Eimeria this chapter. tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Be- cause diclazuril is effective against E. maxima late in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesions scores and improve performance and health of birds challenged with E. maxima.

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Virginiamycin Combination in grams/ton grams/ton Indications for use Limitations Sponsors

(v) 20 ...... Lasalocid 68 to 113 Broiler chickens: For prevention Feed continuously as the sole 066104 of necrotic enteritis caused by ration. Do not feed to laying Clostridium perfringens sus- chickens. For broiler or fryer ceptible to virginiamycin; and chickens only. Lasalocid as for the prevention of coccidi- provided by No. 054771 in osis caused by Eimeria § 510.600(c) of this chapter. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima. (vi) 20 ...... Monensin 90 to 110 Broiler chickens: For prevention Feed continuously as the sole 066104 of necrotic enteritis caused by ration. Do not feed to laying Clostridium perfringens sus- chickens. See § 558.355(d) in ceptible to virginiamycin; and this chapter. Monensin as pro- as an aid in the prevention of vided by No. 058198 in coccidiosis caused by Eimeria § 510.600(c) of this chapter. necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati. (vii) 20 ...... Salinomycin 40 to Broiler chickens: For prevention Feed continuously as the sole 60. of necrotic enteritis caused by ration. Do not feed to chick- Clostridium perfringens sus- ens over 16 weeks of age. Do ceptible to virginiamycin; and not feed to laying chickens. for the prevention of coccidi- Not approved for use with pel- osis caused by Eimeria let binders. May be fatal if ac- tenella, E. necatrix, E. cidentally fed to adult turkeys acervulina, E. maxima, E. or horses. Salinomycin as pro- brunetti, and E. mivati. vided by No. 016592 in § 510.600(c) of this chapter. (viii) 20 ...... Semduramicin 22.7 Broiler chickens: For prevention Feed continuously as the sole 066104 of necrotic enteritis caused by ration. Do not feed to laying Clostridium perfringens sus- hens. Semduramicin as pro- ceptible to virginiamycin; and vided by No. 066104 in for the prevention of coccidi- § 510.600(c) of this chapter. osis caused by Eimeria acervulina, E. brunetti, E. maxima, E mivati/mitis, E. necatrix, and E. tenella. (ix) 20 ...... Semduramicin (bio- Broiler chickens: For prevention Feed continuously as the sole 066104 mass) 22.7. of necrotic enteritis caused by ration. Withdraw 1 day before Clostridium perfringens sus- slaughter. Do not feed to lay- ceptible to virginiamycin; and ing hens. Semduramicin as for the prevention of coccidi- provided by No. 066104 in osis caused by Eimeria § 510.600(c) of this chapter. acervulina, E. brunetti, E. maxima, E mivati/mitis, E. necatrix, and E. tenella.

(2) Swine—

Virginiamycin Combination in grams/ton grams/ton Indications for use Limitations Sponsor

(i) 25...... Growing-finishing swine: As an ...... 066104 aid in control of dysentery in swine up to 120 pounds in animals or on premises with a history of swine dysentery but where symptoms have not yet occurred. (ii) 50 or 100 ...... Growing-finishing swine: For Feed 100 grams per ton for 2 066104 treatment and control of swine weeks, 50 grams per ton dysentery in swine up to 120 thereafter. pounds. (iii) 100...... Growing-finishing swine: For Feed for 2 weeks ...... 066104 treatment of swine dysentery in nonbreeding swine over 120 pounds.

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(3) Cattle—

Virginiamycin Combination in grams/ton grams/ton Indications for use Limitations Sponsor

(i) 13.5 to 16.0...... Cattle fed in confinement for Feed continuously as the sole 066104 slaughter: For reduction of in- ration to provide 85 to 240 cidence of liver abscesses. milligrams per head per day. Not for use in animals intended for breeding. (ii) [Reserved]

[81 FR 95022, Dec. 27, 2016, as amended at 82 FR 11512, Feb. 24, 2017; 82 FR 21692, May 10, 2017]

§ 558.665 Zilpaterol. zilpaterol/head/day in complete feed. If pen consumption of complete feed ex- (a) Specifications. Type A medicated ceeds 26.5 lb/head/day (90 percent dry articles containing 21.77 grams (g) matter basis), zilpaterol should not be zilpaterol hydrochloride per pound. fed in complete feed.’’ (b) Approvals. See No. 000061 in (4) Type B Liquid Feeds can be manu- § 510.600(c) of this chapter. factured containing 68 to 680 g (c) Tolerances. See § 556.765 of this zilpaterol hydrochloride/ton. The liquid chapter. Type B feeds must be maintained at a (d) Special considerations—(1) Labeling pH of 3.8 to 7.5. For liquid feeds stored shall bear the following caution state- in recirculating tank systems: Recircu- ments: ‘‘Zilpaterol hydrochloride is not late immediately prior to use for not for use in animals intended for breed- less than 10 minutes, moving not less ing. Do not allow horses or other than 1 percent of the tank contents per equines access to feed containing minute from the bottom of the tank to zilpaterol. Do not use in veal calves.’’ the top. Recirculate daily as described (2) Labeling of Type A medicated ar- even when not used. For liquid feeds ticles and Type B medicated feeds used stored in mechanical, air or other agi- to manufacture complete Type C medi- tation-type tank systems: Agitate im- cated feeds shall bear the caution mediately prior to use for not less than statement in paragraph (d)(3) of this 10 minutes, creating a turbulence at section. the bottom of the tank that is visible (3) Labeling of complete Type C at the top. Agitate daily as described medicated feeds shall bear the fol- even when not used. lowing caution statements: ‘‘Not to be (e) Conditions of use in cattle. It is ad- fed to cattle in excess of 90 mg ministered in feed as follows:

Zilpaterol hydrochloride Combination in Indications for use Limitations Sponsor in grams/ton grams/ton

(1) 6.8...... Cattle fed in confinement for Feed continuously as the sole ra- 000061 slaughter: For increased rate of tion during the last 20 to 40 weight gain, improved feed effi- days on feed to provide 60 to ciency, and increased carcass 90 mg zilpaterol hydrochloride leanness in cattle fed in con- per head per day. Withdrawal finement for slaughter during period: 3 days. See paragraph the last 20 to 40 days on feed. (d) of this section.

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Zilpaterol hydrochloride Combination in Indications for use Limitations Sponsor in grams/ton grams/ton

(2) 6.8 ...... Monensin 10 to 40 Cattle fed in confinement for Feed continuously as the sole ra- 000061 slaughter: For increased rate of tion during the last 20 to 40 058198 weight gain, improved feed effi- days on feed to provide 60 to ciency, and increased carcass 90 mg zilpaterol hydrochloride leanness in cattle fed in con- per head per day and 0.14 to finement for slaughter during 0.42 mg monensin per pound the last 20 to 40 days on feed; of body weight per day depend- for prevention and control of ing on the severity of the coc- coccidiosis due to Eimeria cidiosis challenge, up to 480 bovis and E. zuernii. mg/head/day monensin. With- drawal period: 3 days. See paragraph (d) of this section. See paragraph § 558.355(d) of this chapter Monensin as provided by No. 058198 in § 510.600(c) of this chapter. (3) 6.8 ...... Melengestrol ace- Heifers fed in confinement for Feed continuously as the sole ra- 000061 tate to provide slaughter: For increased rate of tion during the last 20 to 40 058198 0.25 to 0.5 mg/ weight gain, improved feed effi- days on feed to provide 60 to head/day. ciency, and increased carcass 90 mg zilpaterol hydrochloride leanness in cattle fed in con- per head per day. Withdrawal finement for slaughter during period: 3 days. See paragraph the last 20 to 40 days on feed; (d) of this section. and for suppression of estrus Melengestrol acetate as provided (heat). by Nos. 058198 or 054771 in § 510.600(c) of this chapter. (4) 6.8 ...... Monensin 10 to 40 Heifers fed in confinement for Feed continuously as the sole ra- 000061 plus melengestrol slaughter: For increased rate of tion during the last 20 to 40 058198 acetate to provide weight gain, improved feed effi- days on feed to provide 60 to 0.25 to 0.5 mg/ ciency, and increased carcass 90 mg zilpaterol hydrochloride head/day. leanness in cattle fed in con- per head per day and 0.14 to finement for slaughter during 0.42 mg monensin per pound the last 20 to 40 days on feed; of body weight per day depend- for prevention and control of ing on the severity of the coc- coccidiosis due to Eimeria cidiosis challenge, up to 480 bovis and E. zuernii; and for mg/head/day monensin. With- suppression of estrus (heat). drawal period: 3 days. See paragraph (d) of this section. See paragraphs §§ 558.342(d) and 558.355(d) of this chapter. Monensin as provided by No. 058198; melengestrol acetate as provided by Nos. 058198 or 054771 in § 510.600(c) of this chapter. (5)–(6) [Reserved]. (7) 6.8 to 24...... Cattle fed in confinement for Feed continuously during the last 000061 slaughter: For increased rate of 20 to 40 days on feed to pro- weight gain, improved feed effi- vide 60 mg zilpaterol hydro- ciency, and increased carcass chloride per head per day. leanness in cattle fed in con- Withdrawal period: 3 days. See finement for slaughter during paragraph (d) of this section. the last 20 to 40 days on feed. (8) 6.8 to 24 ...... Monensin 10 to 40 Cattle fed in confinement for Feed continuously during the last 000061 slaughter: For increased rate of 20 to 40 days on feed to pro- weight gain, improved feed effi- vide 60 mg zilpaterol hydro- ciency, and increased carcass chloride per head per day and leanness in cattle fed in con- 0.14 to 0.42 mg monensin per finement for slaughter during pound of body weight per day the last 20 to 40 days on feed; depending on the severity of and for prevention and control the coccidiosis challenge, up to of coccidiosis due to Eimeria 480 mg/head/day monensin. bovis and E. zuernii. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraph § 558.355(d) of this chapter. Monensin as provided by No. 058198 in § 510.600(c) of this chapter.

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Zilpaterol hydrochloride Combination in Indications for use Limitations Sponsor in grams/ton grams/ton

(9) 6.8 to 24 ...... Melengestrol ace- Heifers fed in confinement for Feed continuously during the last 000061 tate to provide slaughter: For increased rate of 20 to 40 days on feed to pro- 0.25 to 0.5 mg/ weight gain, improved feed effi- vide 60 mg zilpaterol hydro- head/day. ciency, and increased carcass chloride per head per day. leanness in cattle fed in con- Withdrawal period: 3 days. See finement for slaughter during paragraph (d) of this section. the last 20 to 40 days on feed; See paragraph § 558.342(d) of and for suppression of estrus this part. (heat). Melengestrol acetate as provided by No. 054771 in § 510.600(c) of this chapter. (10) 6.8 to 24 ...... Monensin 10 to 40, Heifers fed in confinement for Feed continuously during the last 000061 plus melengestrol slaughter: For increased rate of 20 to 40 days on feed to pro- acetate to provide weight gain, improved feed effi- vide 60 mg zilpaterol hydro- 0.25 to 0.5 mg/ ciency, and increased carcass chloride per head per day and head/day. leanness in cattle fed in con- 0.14 to 0.42 mg monensin per finement for slaughter during pound of body weight per day the last 20 to 40 days on feed; depending on the severity of for prevention and control of the coccidiosis challenge, up to coccidiosis due to Eimeria 480 mg/head/day monensin. bovis and E. zuernii; and for Withdrawal period: 3 days. See suppression of estrus (heat). paragraph (d) of this section. See paragraphs §§ 558.342(d) and 558.355(d) of this chapter. Monensin as provided by No. 058198; melengestrol acetate as provided by No. 054771 in § 510.600(c) of this chapter.

(f) Zilpaterol may also be used in § 558.680 Zoalene. combination with tylosin as in § 558.625. (a) Specifications. Type A medicated [71 FR 53006, Sept. 8, 2006, as amended at 72 article containing 25 percent zoalene. FR 9245, Mar. 1, 2007; 72 FR 6019, Feb. 1, 2008; (b) Approvals. See No. 054771 in 73 FR 14385, Mar. 18, 2008; 73 FR 16755, Mar. 31, 2008; 73 FR 18959, Apr. 8, 2008; 73 FR 19432, § 510.600(c) of this chapter. Apr. 10, 2008; 74 FR 61517, Nov. 25, 2009; 75 FR (c) Related tolerances. See § 556.770 of 11451, Mar. 11, 2010; 77 FR 31724, May 30, 2012; this chapter. 78 FR 42008, July 15, 2013; 78 FR 52852, Aug. (d) Conditions of use—(1) Chickens— 27, 2013; 80 FR 13232, Mar. 13, 2015; 80 FR 53460, Sept. 4, 2015; 81 FR 48703, July 26, 2016; 81 FR 95025, Dec. 27, 2016]

Zoalene in grams/ Combination in ton grams per ton Indications for use Limitations Sponsor

(i) 36.3 to 113.5 ...... Replacement chickens: For devel- Grower ration not to be fed to 054771 opment of active immunity to birds over 14 weeks of age; as coccidiosis. follows:

Starter ration Grower ration Growing conditions Grams per ton Grams per ton

Severe exposure ...... 113.5 (0.0125%) 75.4–113.5 (0.0083%–0.0125%) Light to moderate exposure ...... 75.4–113.5 36.3–75.4 (0.0083%–0.0125%) (0.004%–0.0083%)

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Zoalene in grams/ Combination in ton grams per ton Indications for use Limitations Sponsor

(ii) 36.3–113.5 ...... Bacitracin Replacement chickens: For devel- Feed continuously as sole ration 054771 methylenedisalicy- opment of active immunity to as in subtable in item (i). Grow- late 4 to 50. coccidiosis; and for increased er ration not to be fed to birds rate of weight gain and im- over 14 weeks of age. Baci- proved feed efficiency. tracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. (iii) 36.3–113.5 ...... Bacitracin Replacement chickens: For devel- Feed continuously as sole ration 054771 methylenedisalicy- opment of active immunity to as in subtable in item (i). Grow- late 50. coccidiosis; and as an aid in er ration not to be fed to birds the prevention of necrotic enter- over 14 weeks of age. Baci- itis caused or complicated by tracin methylenedisalicylate as Clostridium spp. or other orga- provided by No. 054771 in nisms susceptible to bacitracin. § 510.600(c) of this chapter. (iv) 36.3–113.5 ...... Bacitracin Replacement chickens: For devel- Feed continuously as sole ration 054771 methylenedisalicy- opment of active immunity to as in subtable in item (i). To late 100 to 200. coccidiosis; and as an aid in control necrotic enteritis, start the control of necrotic enteritis medication at first clinical signs caused or complicated by Clos- of disease; vary bacitracin dos- tridium spp. or other organisms age based on the severity of in- susceptible to bacitracin. fection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ton). Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. (v) 113.5 ...... Broiler chickens: For prevention Feed continuously as sole ration 054771 and control of coccidiosis. (vi) 113.5 ...... Bacitracin Broiler chickens: As an aid in the Feed continuously as sole ration. 054771 methylenedisalicy- prevention and control of coc- Bacitracin methylenedisalicylate late 4 to 50. cidiosis; and for increased rate as provided by No. 054771 in of weight gain and improved § 510.600(c) of this chapter. feed efficiency. (vii) 113.5 ...... Bacitracin Broiler chickens: For prevention Feed continuously as sole ration. 054771 methylenedisalicy- and control of coccidiosis; and Bacitracin methylenedisalicylate late 50. as an aid in the prevention of as provided by No. 054771 in necrotic enteritis caused or § 510.600(c) of this chapter. complicated by Clostridium spp. or other organisms susceptible to bacitracin. (viii) 113.5 ...... Bacitracin Broiler chickens: For prevention Feed continuously as sole ration. 054771 methylenedisalicy- and control of coccidiosis; and To control necrotic enteritis, late 100 to 200. as an aid in the control of ne- start medication at first clinical crotic enteritis caused or com- signs of disease; vary baci- plicated by Clostridium spp. or tracin dosage based on the se- other organisms susceptible to verity of infection; administer bacitracin. continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ton). Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. (ix) 113.5 ...... Bambermycins 1 ..... Broiler chickens: As an aid in the Feed continuously as sole ration. 016592 prevention and control of coc- Do not feed to chickens over cidiosis; and for increased rate 14 weeks of age. of weight gain and improved Bambermycins as provided by feed efficiency. No. 016592 in § 510.600(c) of this chapter.

(2) Turkeys—

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Zoalene in grams/ Combination in ton grams per ton Indications for use Limitations Sponsor

(i) 113.5 to 170.3 ...... Growing turkeys: For prevention Feed continuously as sole ration. 054771 and control of coccidiosis. For turkeys grown for meat purposes only. Do not feed to laying birds. (ii) 113.5 to 170.3 ... Bacitracin Growing turkeys: For prevention Feed continuously as sole ration 054771 methylenedisalicy- and control of coccidiosis; and until 14 to 16 weeks of age. For late 4 to 50. for increased rate of weight turkeys grown for meat pur- gain and improved feed effi- poses only. Do not feed to lay- ciency. ing birds.

(3) Zoalene may also be used in com- 570.38 Determination of food additive sta- bination with: tus. (i)–(ii) [Reserved] Subparts C–D [Reserved] (iii) Lincomycin as in § 558.325. [41 FR 11005, Mar. 15, 1976, as amended at 42 Subpart E—Generally Recognized as Safe FR 18618, Apr. 8, 1977; 42 FR 20817, Apr. 22, (GRAS) Notice 1977; 42 FR 36995, July 19, 1977; 51 FR 7401, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 55 FR 570.203 Definitions. 8461, Mar. 8, 1990; 57 FR 8403, Mar. 10, 1992; 57 570.205 Opportunity to submit a GRAS no- FR 8578, Mar. 11, 1992; 61 FR 35957, July 9, tice. 1996; 63 FR 38750, July 20, 1998; 67 FR 6868, 570.210 How to send your GRAS notice to Feb. 14, 2002; 71 FR 16223, Mar. 31, 2006; 71 FR FDA. 570.215 Incorporation into a GRAS notice. 27958, May 15, 2006; 76 FR 17027, Mar. 28, 2011; 570.220 General requirements applicable to a 79 FR 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, GRAS notice. 2014; 81 FR 17610, Mar. 30, 2016; 81 FR 95025, 570.225 Part 1 of a GRAS notice: Signed Dec. 27, 2016; 82 FR 21693, May 10, 2017] statements and certification. 570.230 Part 2 of a GRAS notice: Identity, PART 564 [RESERVED] method of manufacture, specifications, and physical or technical effect. 570.235 Part 3 of a GRAS notice: Target ani- PART 570—FOOD ADDITIVES mal and human exposures. 570.240 Part 4 of a GRAS notice: Self-lim- Subpart A—General Provisions iting levels of use. 570.245 Part 5 of a GRAS notice: Experience Sec. based on common use in food before 1958. 570.3 Definitions. 570.250 Part 6 of a GRAS notice: Narrative. 570.6 Opinion letters on food additive sta- 570.255 Part 7 of a GRAS notice: List of sup- tus. porting data and information in your 570.13 Indirect food additives resulting from GRAS notice. packaging materials prior sanctioned for 570.260 Steps you may take before FDA re- animal feed and pet food. sponds to your GRAS notice. 570.14 Indirect food additives resulting from 570.265 What FDA will do with a GRAS no- packaging materials for animal feed and tice. pet food. 570.275 Public disclosure of a GRAS notice. 570.15 Adoption of regulation on initiative 570.280 Submission of a supplement. of Commissioner. 570.17 Exemption for investigational use AUTHORITY: 21 U.S.C. 321, 341, 342, 346a, 348, and procedure for obtaining authoriza- 371. tion to market edible products from ex- SOURCE: 41 FR 38644, Sept. 10, 1976, unless perimental animals. otherwise noted. 570.18 Tolerances for related food additives. 570.19 Pesticide chemicals in processed foods. Subpart A—General Provisions

Subpart B—Food Additive Safety § 570.3 Definitions. (a) Secretary means the Secretary of 570.20 General principles for evaluating the safety of food additives. Health and Human Services. 570.30 Eligibility for classification as gen- (b) Department means the Department erally recognized as safe (GRAS). of Health and Human Services. 570.35 Affirmation of generally recognized (c) Commissioner means the Commis- as safe (GRAS) status. sioner of Food and Drugs.

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(d) As used in this part, the term act (i) Safe or safety means that there is means the Federal Food, Drug, and a reasonable certainty in the minds of Cosmetic Act approved June 25, 1936 (52 competent scientists that the sub- Stat. 1040 et seq., as amended; 21 U.S.C. stance is not harmful under the condi- 301–392). tions of its intended use. It is impos- (e) Food additives includes all sub- sible in the present state of scientific stances not exempted by section 201(s) knowledge to establish with complete of the act, the intended use of which certainty the absolute harmlessness of results or may reasonably be expected the use of any substance. Safety may to result, directly or indirectly, either be determined by scientific procedures in their becoming a component of food or by general recognition of safety. In or otherwise affecting the characteris- determining safety, the following fac- tics of food. A material used in the pro- tors shall be considered: duction of containers and packages is (1) The probable consumption of the subject to the definition if it may rea- substance and of any substance formed sonably be expected to become a com- in or on food because of its use; ponent, or to affect the characteristics, (2) The cumulative effect of the sub- directly or indirectly, of food packed in stance in the diet, taking into account the container. Affecting the characteris- any chemically or pharmacologically tics of food does not include such phys- related substance or substances in such ical effects, as protecting contents of diet; packages, preserving shape, and pre- (3) Safety factors which, in the opin- venting moisture loss. If there is no ion of experts qualified by scientific migration of a packaging component training and experience to evaluate the from the package to the food, it does safety of food and food ingredients, are not become a component of the food generally recognized as appropriate. and thus is not a food additive. A sub- (j) The term nonperishable processed stance that does not become a compo- food means any processed food not sub- nent of food, but that is used, for exam- ject to rapid decay or deterioration ple, in preparing an ingredient of the that would render it unfit for consump- food to give a different flavor, texture, tion. Not included are hermetically or other characteristic in the food, sealed foods and other processed foods may be a food additive. requiring refrigeration. (f) Common use in food means a sub- (k) General recognition of safety shall stantial history of consumption of a be in accordance with § 570.30. substance by a significant number of (l) Prior sanction means an explicit animals of the species to which the approval granted with respect to use of substance is intended to be fed (and, for a substance in food prior to September food-producing animals fed with such 6, 1958, by the Food Drug and Adminis- substance, also means a substantial tration or the United States Depart- history of consumption by humans con- ment of Agriculture pursuant to the suming human foods derived from Federal Food, Drug, and Cosmetic Act, those food-producing animals), prior to the Poultry Products Inspection Act, January 1, 1958. or the Meat Inspection Act. (g) The word substance in the defini- (m) Food includes human food, sub- tion of the term food additive includes a stances migrating to food from food- food or feed or a component of a food or contact articles, pet food, and animal feed consisting of one or more ingredi- feed. ents. (n) Food-producing animal means an (h) Scientific procedures include the animal used to produce human food. application of scientific data (includ- [41 FR 38644, Sept. 10, 1976, as amended at 42 ing, as appropriate, data from human, FR 55206, Oct. 14, 1977; 81 FR 55051, Aug. 17, animal, analytical, or other scientific 2016] studies), information, and methods, whether published or unpublished, as § 570.6 Opinion letters on food addi- well as the application of scientific tive status. principles, appropriate to establish the (a) Over the years the Food and Drug safety of a substance under the condi- Administration has given informal tions of its intended use. written opinions to inquirers as to the

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safety of articles intended for use as such letter forwards a copy of each to components of, or in contact with, the Department of Health and Human food. Prior to the enactment of the Services, Food and Drug Administra- Food Additives Amendment of 1958 tion, Center for Veterinary Medicine, (Pub. L. 85–929, Sept. 6, 1958), these Office of Surveillance and Compliance opinions were given pursuant to sec- (HFV–200), 7500 Standish Pl., Rockville, tion 402(a)(1) of the Federal Food, MD 20855, along with a copy of his let- Drug, and Cosmetic Act, which reads in ter of inquiry, on or before July 23, part: ‘‘A food shall be deemed to be 1970. adulterated if it bears or contains any (f) This section does not apply to food poisonous or deleterious substance additive status opinion letters per- which may render it injurious to taining to articles that were considered health’’. by the Food and Drug Administration (b) Since enactment of the Food Ad- to be food additives nor to articles in- ditives Amendment, the Food and Drug cluded in regulations in this Sub- Administration has advised such inquirers that an article: chapter E if the articles are used in ac- (1) Is a food additive within the cordance with the requirements of such meaning of section 201(s) of the act; or regulations. (2) Is generally recognized as safe [41 FR 38644, Sept. 10, 1976, as amended at 54 (GRAS); or FR 18281, Apr. 28, 1989; 57 FR 6476, Feb. 25, (3) Has prior sanction or approval 1992] under that amendment; or (4) Is not a food additive under the § 570.13 Indirect food additives result- conditions of intended use. ing from packaging materials prior (c) In the interest of the public sanctioned for animal feed and pet health, such articles which have been food. considered in the past by the Food and Regulations providing for the use of Drug Administration to be safe under food packaging materials as prior sanc- the provisions of section 402(a)(1), or to tioned in part 181 of this chapter are be generally recognized as safe for incorporated in Subchapter E as appli- their intended use, or to have prior cable to packaging materials used for sanction or approval, or not to be food animal feed and pet food. additives under the conditions of intended use, must be reexamined in the [42 FR 14091, Mar. 15, 1977] light of current scientific information and current principles for evaluating § 570.14 Indirect food additives result- the safety of food additives if their use ing from packaging materials for animal feed and pet food. is to be continued. (d) Because of the time span in- Regulations providing for the use of volved, copies of many of the letters in food packaging materials in parts 174 which the Food and Drug Administra- through 179 of this chapter are incor- tion has expressed an informal opinion porated in Subchapter E as applicable concerning the status of such articles to packaging materials used for animal may no longer be in the file of the Food feed and pet food. and Drug Administration. In the absence of information concerning the [42 FR 14091, Mar. 15, 1977] names and uses made of all the articles § 570.15 Adoption of regulation on ini- referred to in such letters, their safety tiative of Commissioner. of use cannot be reexamined. For this reason all food additive status opinions (a) The Commissioner upon his own of the kind described in paragraph (c) initiative may propose the issuance of of this section given by the Food and a regulation prescribing, with respect Drug Administration are hereby re- to any particular use of a food additive, voked. the conditions under which such addi- (e) The prior opinions of the kind de- tive may be safely used. Notice of such scribed in paragraph (c) of this section proposal shall be published in the FED- will be replaced by qualified and cur- ERAL REGISTER and shall state the rea- rent opinions if the recipient of each sons for the proposal.

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(b) Action upon a proposal made by § 570.18 Tolerances for related food ad- the Commissioner shall proceed as pro- ditives. vided in part 10 of this chapter. (a) Food additives that cause similar [41 FR 38644, Sept. 10, 1976, as amended at 42 or related pharmacological effects will FR 4717, Jan. 25, 1977; 42 FR 15675, Mar. 22, be regarded as a class, and in the ab- 1977] sence of evidence to the contrary, as having additive toxic effects and will § 570.17 Exemption for investigational be considered as related food additives. use and procedure for obtaining au- (b) Tolerances established for such thorization to market edible prod- related food additives may limit the ucts from experimental animals. amount of a common component that A food additive or food containing a may be present, or may limit the food additive intended for investiga- amount of biological activity (such as tional use by qualified experts shall be cholinesterase inhibition) that may be exempt from the requirements of sec- present or may limit the total amount tion 409 of the act under the following of related food additives that may be conditions: present. (a) If intended for investigational use (c) Where food additives from two or in vitro or in laboratory research ani- more chemicals in the same class are mals, it bears a label which states present in or on a food, the tolerance prominently, in addition to the other for the total of such additives shall be information required by the act, the the same as that for the additive hav- warning: ing the lowest numerical tolerance in this class, unless there are available Caution. Contains a new food additive for methods that permit quantitative de- investigational use only in laboratory re- termination of the amount of each food search animals or for tests in vitro. Not for additive present or unless it is shown use in humans. that a higher tolerance is reasonably (b) If intended for use in animals required for the combined additives to other than laboratory research animals accomplish the physical or technical and if the edible products of the ani- effect for which such combined addi- mals are to be marketed as food, per- tives are intended and that the higher mission for the marketing of the edible tolerance will be safe. products as food has been requested by (d) Where residues from two or more the sponsor, and authorization has additives in the same class are present been granted by the Food and Drug Ad- in or on a food and there are available ministration in accordance with § 511.1 methods that permit quantitative de- of this chapter or by the Department of termination of each residue, the quan- Agriculture in accordance with 9 CFR tity of combined residues that are 309.17, and it bears a label which states within the tolerance may be deter- prominently, in addition to the other mined as follows: information required by the act, the (1) Determine the quantity of each warning: residue present. (2) Divide the quantity of each res- Caution. Contains a new food additive for idue by the tolerance that would apply use only in investigational animals. Not for if it occurred alone, and multiply by use in humans. Edible products of investigational animals 100 to determine the percentage of the are not to be used for food unless authoriza- permitted amount of residue present. tion has been granted by the U.S. Food and (3) Add the percentages so obtained Drug Administration or by the U.S. Depart- for all residues present. ment of Agriculture. (4) The sum of the percentages shall not exceed 100 percent. (c) If intended for nonclinical laboratory studies in food-producing animals, § 570.19 Pesticide chemicals in proc- the study is conducted in compliance essed foods. with the regulations set forth in part 58 When pesticide chemical residues of this chapter. occur in processed foods due to the use [41 FR 38644, Sept. 10, 1976, as amended at 43 of raw agricultural commodities that FR 60023, Dec. 22, 1978] bore or contained a pesticide chemical

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in conformity with an exemption emy of Sciences-National Research granted or a tolerance prescribed under Council if, from available evidence, the section 408 of the act, the processed Commissioner finds that the proce- food will not be regarded as adulter- dures used give results as reliable as, ated so long as good manufacturing or more reliable than, those reasonably practice has been followed in removing to be expected from the use of the out- any residue from the raw agricultural lined procedures. In reaching a deci- commodity in the processing (such as sion, the Commissioner will give due by peeling or washing) and so long as weight to the anticipated levels and the concentration of the residue in the patterns of consumption of the additive processed food when ready to eat is not specified or reasonably inferable. For greater than the tolerance prescribed the purposes of this section, the prin- for the raw agricultural commodity. ciples for evaluating safety of additives But when the concentration of residue set forth in the above-mentioned publi- in the processed food when ready to eat cations will apply to any substance is higher than the tolerance prescribed that may properly be classified as a for the raw agricultural commodity, food additive as defined in section the processed food is adulterated unless 201(s) of the act. the higher concentration is permitted (b) Upon written request describing by a tolerance obtained under section the proposed use of an additive and the 409 of the act. For example, if fruit proposed experiments to determine its bearing a residue of 7 parts per million safety, the Commissioner will advise a of DDT permitted on the raw agricul- person who wishes to establish the tural commodity is dried and a residue safety of a food additive whether he be- in excess of 7 parts per million of DDT lieves the experiments planned will results on the dried fruit, the dehy- yield data adequate for an evaluation drated fruit is adulterated unless the of the safety of the additive. higher tolerance for DDT is authorized by the regulations in this part. Food § 570.30 Eligibility for classification as that is itself ready to eat, and which generally recognized as safe contains a higher residue than allowed (GRAS). for the raw agricultural commodity, (a) General recognition of safety may may not be legalized by blending or be based only on the views of experts mixing with other foods to reduce the qualified by scientific training and ex- residue in the mixed food below the tol- perience to evaluate the safety of sub- erance prescribed for the raw agricul- stances directly or indirectly added to tural commodity. food. The basis of such views may be either (1) scientific procedures or (2) in Subpart B—Food Additive Safety the case of a substance used in food prior to January 1, 1958, through expe- § 570.20 General principles for evalu- rience based on common use in food. ating the safety of food additives. General recognition of safety requires (a) In reaching a decision on any pe- common knowledge throughout the sci- tition filed under section 409 of the act, entific community knowledgeable the Commissioner will give full consid- about the safety of substances directly eration to the specific biological prop- or indirectly added to food that there erties of the compound and the ade- is reasonable certainty that the sub- quacy of the methods employed to stance is not harmful to either the tar- demonstrate safety for the proposed get animal or to humans consuming use, and the Commissioner will be human food derived from food-pro- guided by the principles and procedures ducing animals under the conditions of for establishing the safety of food addi- its intended use (see § 570.3(i)). tives stated in current publications of (b) General recognition of safety the National Academy of Sciences-Na- based upon scientific procedures shall tional Research Council. A petition require the same quantity and quality will not be denied, however, by reason of scientific evidence as is required to of the petitioner’s having followed pro- obtain approval of a food additive. Gen- cedures other than those outlined in eral recognition of safety through sci- the publications of the National Acad- entific procedures shall address safety

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for both the target animal and for hu- the country in which the history of use mans consuming human food derived has occurred and readily available to from food-producing animals and shall interested qualified experts in the be based upon the application of gen- United States. A person who concludes erally available and accepted scientific that a use of a substance is GRAS data, information, or methods, which through experience based on its com- ordinarily are published, as well as the mon use in food outside of the United application of scientific principles, and States should notify FDA of that view may be corroborated by the application in accordance with subpart E of this of unpublished scientific data, informa- part. tion, or methods. (d) The food ingredients listed as (c)(1) General recognition of safety GRAS in part 582 of this chapter or af- through experience based on common firmed as GRAS in part 584 of this use in food prior to January 1, 1958, chapter do not include all substances shall address safety for both the target that are generally recognized as safe animal and for humans consuming for their intended use in food. Because human food derived from food-proof the large number of substances the ducing animals and may be achieved intended use of which results or may without the quantity or quality of sci- reasonably be expected to result, di- entific procedures required for ap- rectly or indirectly, in their becoming proval of a food additive. General rec- a component or otherwise affecting the ognition of safety through experience characteristics of food, it is impracti- based on common use in food prior to cable to list all such substances that January 1, 1958, shall be based solely on are GRAS. A food ingredient of natural food use of the substance in the same biological origin that has been widely animal species prior to January 1, 1958, consumed for its nutrient properties in and shall ordinarily be based upon gen- the United States prior to January 1, erally available data and information. 1958, without known detrimental ef- An ingredient not in common use in fects, which is subject only to conven- food prior to January 1, 1958, may tional processing as practiced prior to achieve general recognition of safety January 1, 1958, and for which no only through scientific procedures. known safety hazard exists, will ordi- (2) A substance used in food prior to narily be regarded as GRAS without January 1, 1958, may be generally rec- specific inclusion in part 582 or part 584 ognized as safe through experience of this chapter. based on its common use in food when (e) A food ingredient that is not that use occurred exclusively or pri- GRAS or subject to a prior sanction re- marily outside of the United States if quires a food additive regulation pro- the information about the experience mulgated under section 409 of the act establishes that the substance is safe before it may be directly or indirectly under the conditions of its intended use added to food. within the meaning of section 201(u) of (f) A food ingredient that is listed as the Federal Food, Drug, and Cosmetic GRAS in part 582 of this chapter shall Act (see also § 570.3(i)) for both the tar- be regarded as GRAS only if, in addi- get animal and for humans consuming tion to all the requirements in the ap- human food derived from food-pro- plicable regulation, it also meets all of ducing animals. Common use in food the following requirements: prior to January 1, 1958, that occurred (1) It complies with any applicable outside of the United States shall be specifications, or in the absence of such documented by published or other in- specifications, shall be of a purity suit- formation and shall be corroborated by able for its intended use. information from a second, inde- (2) It performs an appropriate func- pendent source that confirms the his- tion in the food or food-contact article tory and circumstances of use of the in which it is used. substance. The information used to (3) It is used at a level no higher than document and to corroborate the his- necessary to achieve its intended pur- tory and circumstances of use of the pose in that food or, if used as a compo- substance must be generally available; nent of a food-contact article, at a that is, it must be widely available in level no higher than necessary to

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achieve its intended purpose in that ar- (b)(1) If the Commissioner proposes ticle. on his own initiative that a substance (g) New information may at any time is entitled to affirmation as GRAS require reconsideration of the GRAS under the conditions of its intended status of a food ingredient. Any change use, he will place all of the data and in- in status shall be accomplished pursu- formation on which he relies on public ant to § 570.38. file in the office of the Division of (h) If a substance is affirmed as Dockets Management and will publish GRAS pursuant to § 570.35 and listed in in the FEDERAL REGISTER a notice giv- a regulation with no limitation other ing the name of the substance, its pro- than good manufacturing practice, it posed uses, and any limitations pro- shall be regarded as GRAS if its condi- posed for purposes other than safety. tions of use are not significantly dif- (2) The FEDERAL REGISTER notice will ferent from those reported in the regu- allow a period of 60 days during which lation as the basis on which the GRAS any interested person may review the status of the substance was affirmed. If data and information and/or file com- the conditions of use are significantly ments with the Division of Dockets different, such use of the substance Management. Copies of all comments may not be GRAS. In such case a man- received shall be made available for ex- ufacturer may not rely on the regula- amination in the Division of Dockets tion as authorizing the use but must Management’s office. independently establish that the use is (3) The Commissioner will evaluate GRAS or must use the substance in ac- all comments received. If he concludes cordance with a food additive regula- that there is convincing evidence that tion. the substance is GRAS under the con- (i) If an ingredient is affirmed as ditions of its intended use as described GRAS pursuant to § 570.35 and listed in in § 570.30, he will publish a notice in a regulation with specific limitation(s), the FEDERAL REGISTER listing the it may be used in food only within such GRAS conditions of use in this sub- limitation(s) (including the category of chapter E. food(s), the functional use(s) of the in- (4) If, after evaluation of the com- gredient, and the level(s) of use). Any ments, the Commissioner concludes use of such an ingredient not in full that there is a lack of convincing evi- compliance with each such established dence that the substance is GRAS limitation shall require a food additive under the conditions of its intended use regulation. and that it should be considered a food (j) Pursuant to § 570.35, a food ingre- additive subject to section 409 of the dient may be affirmed as GRAS and Federal Food, Drug, and Cosmetic Act, listed in a regulation for a specific he shall publish a notice thereof in the use(s) without a general evaluation of FEDERAL REGISTER in accordance with use of the ingredient. In addition to the § 570.38. use(s) specified in the regulation, other uses of such an ingredient may also be [41 FR 38644, Sept. 10, 1976, as amended at 42 GRAS. Any affirmation of GRAS status FR 4717, Jan. 25, 1977; 42 FR 15675, Mar. 22, for a specific use(s), without a general 1977; 42 FR 55207, Oct. 10, 1977; 50 FR 7517, evaluation of use of the ingredient, is Feb. 22, 1985; 50 FR 16668, Apr. 26, 1985; 54 FR 18281, Apr. 28, 1989; 62 FR 40600, July 29, 1997; subject to reconsideration upon such 81 FR 55052, Aug. 17, 2016] evaluation. [42 FR 55206, Oct. 14, 1977, as amended at 81 § 570.38 Determination of food addi- FR 55052, Aug. 17, 2016] tive status. (a) The Commissioner may, in ac- § 570.35 Affirmation of generally recog- cordance with § 570.35(b)(4), publish a nized as safe (GRAS) status. notice in the FEDERAL REGISTER deter- (a) The Commissioner, on his own mining that a substance is not GRAS initiative, may affirm that a substance under the conditions of its intended use that directly or indirectly becomes a and is a food additive subject to section component of food is GRAS under the 409 of the Federal Food, Drug, and Cos- conditions of its intended use. metic Act.

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(b)(1) The Commissioner, on his own for use of the substance, he will con- initiative or on the petition of any in- currently propose a separate regulation terested person, pursuant to part 10 of covering such use of the ingredient this chapter, may issue a notice in the under this subchapter E. If the Com- FEDERAL REGISTER proposing to deter- missioner is unaware of any such appli- mine that a substance is not GRAS and cable prior sanction, the proposed regu- is a food additive subject to section 409 lation will so state and will require any of the act. Any petition shall include person who intends to assert or rely on all relevant data and information of such sanction to submit proof of its ex- the type described in § 571.130(b) of this istence. Any regulation promulgated chapter. The Commissioner will place pursuant to this section constitutes a all of the data and information on determination that excluded uses which he relies on public file in the Di- would result in adulteration of the food vision of Dockets Management and will in violation of section 402 of the act, include in the FEDERAL REGISTER no- and the failure of any person to come tice the name of the substance, its forward with proof of such an applica- known uses, and a summary of the ble prior sanction in response to the basis for the determination. proposal will constitute a waiver of the (2) The FEDERAL REGISTER notice will right to assert or rely on such sanction allow a period of 60 days during which at any later time. The notice will also any interested person may review the constitute a proposal to establish a data and information and/or file com- regulation under this subchapter E., in- ments with the Division of Dockets corporating the same provisions, in the Management. Copies of all comments event that such a regulation is deter- shall be made available for examina- mined to be appropriate as a result of tion in the Division of Dockets Man- submission of proof of such an applica- agement. ble prior sanction in response to the (3) The Commissioner will evaluate proposal. all comments received. If he concludes [41 FR 38644, Sept. 10, 1976, as amended at 42 that there is a lack of convincing evi- FR 4717, Jan. 25, 1977; 42 FR 15675, Mar. 22, dence that the substance is GRAS or is 1977; 42 FR 55207, Oct. 14, 1977; 54 FR 18281, otherwise exempt from the definition Apr. 28, 1989; 81 FR 55052, Aug. 17, 2016] of a food additive in section 201(s) of the act, he will publish a notice thereof Subparts C–D [Reserved] in the FEDERAL REGISTER. If he concludes that there is convincing evidence that the substance is GRAS, he Subpart E—Generally Recognized will publish an order in the FEDERAL as Safe (GRAS) Notice REGISTER listing the substance in this subchapter E as GRAS. SOURCE: 81 FR 55052, Aug. 17, 2016, unless (c) A FEDERAL REGISTER notice deter- otherwise noted. mining that a substance is a food additive shall provide for the use of the ad- § 570.203 Definitions. ditive in food or food-contact surfaces The definitions and interpretations as follows: of terms in § 570.3 apply to such terms (1) It may promulgate a food additive when used in this subpart. The fol- regulation governing use of the addi- lowing definitions also apply: tive. Amendment means any data and infor- (2) It may promulgate an interim mation that you submit regarding a food additive regulation governing use filed GRAS notice before we respond to of the additive. your notice by letter in accordance (3) It may require discontinuation of with § 570.265(b)(1) or cease to evaluate the use of the additive. your notice in accordance with (4) It may adopt any combination of § 570.265(b)(3). the above three approaches for dif- GRAS means generally recognized as ferent uses or levels of use of the addi- safe. tive. GRAS notice means a submission that (d) If the Commissioner of Food and informs us of your view that a sub- Drugs is aware of any prior sanction stance is not subject to the premarket

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approval requirements of the Federal § 570.215 Incorporation into a GRAS Food, Drug, and Cosmetic Act based on notice. your conclusion that the substance is You may incorporate into your GRAS under the conditions of its in- GRAS notice either specifically identi- tended use in accordance with § 570.30. fied data and information that you pre- Notified substance means the sub- viously submitted to the Center for stance that is the subject of your Veterinary Medicine (CVM), or specifi- GRAS notice. cally identified publicly available data Notifier means the person (e.g., an in- and information submitted by another dividual, partnership, corporation, as- party, when such data and information sociation, or other legal entity) who is remain in CVM’s records, such as data responsible for the GRAS notice, even and information contained in a pre- if another person (such as an attorney, vious GRAS notice or a food additive agent, or qualified expert) prepares or petition. submits the notice or provides an opinion about the basis for a conclusion of § 570.220 General requirements appli- GRAS status. cable to a GRAS notice. Qualified expert means an individual (a) A GRAS notice has seven parts as who is qualified by scientific training required by §§ 570.225 through 570.255. and experience to evaluate the safety You must submit the data and infor- of substances under the conditions of mation specified in each of these parts their intended use in animal food. on separate pages or sets of pages. Supplement means any data and infor- (b) You must include each of the mation that you submit regarding a seven parts in your GRAS notice. If filed GRAS notice after we respond to you do not include a part, you must in- your notice by letter in accordance clude with your GRAS notice an expla- with § 570.265(b)(1) or cease to evaluate nation of why that part does not apply your notice in accordance with to your GRAS notice. § 570.265(b)(3). We, our, and us refer to the United § 570.225 Part 1 of a GRAS notice: States Food and Drug Administration Signed statements and certification. (FDA). (a) Part 1 of your GRAS notice must You and your refer to a notifier. be dated and signed by a responsible official of your organization, or by your § 570.205 Opportunity to submit a attorney or agent. GRAS notice. (b) Except as required by paragraph Any person may notify FDA of a view (c)(8) of this section, you must not in- that a substance is not subject to the clude any information that is trade se- premarket approval requirements of cret or confidential commercial infor- section 409 of the Federal Food, Drug, mation in Part 1 of your GRAS notice. and Cosmetic Act based on that per- (c) In Part 1 of your GRAS notice, son’s conclusion that the substance is you must: GRAS under the conditions of its in- (1) Inform us that you are submitting tended use. a GRAS notice in accordance with this subpart; § 570.210 How to send your GRAS no- (2) Provide the name and address of tice to FDA. your organization; (a) Send your GRAS notice to the Di- (3) Provide the name of the notified vision of Animal Feeds (HFV–220), Cen- substance, using an appropriately deter for Veterinary Medicine, Food and scriptive term; Drug Administration, 7519 Standish (4) Describe the intended conditions Pl., Rockville, MD 20855. of use of the notified substance, includ- (b) When you submit your GRAS no- ing stating whether the substance will tice, you may do so either in an elec- be added to food (including drinking tronic format that is accessible for our water) for animals in which the sub- evaluation or on paper. If you send stance will be used; identifying the your GRAS notice on paper, a single foods to which it will be added, the lev- paper copy is sufficient. els of use in such foods, and the animal

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species for which these foods are in- (10) State both the name and the po- tended (including, when appropriate, a sition or title of the person who signs description of a subpopulation expected the GRAS notice. to consume the notified substance); and the purposes for which the sub- § 570.230 Part 2 of a GRAS notice: Identity, method of manufacture, stance will be used; specifications, and physical or tech- (5) Inform us of the statutory basis nical effect. for your conclusion of GRAS status In Part 2 of your GRAS notice, you (i.e., through scientific procedures in must include: accordance with § 570.30(a) and (b) or (a) Scientific data and information through experience based on common that identifies the notified substance. use in animal food in accordance with (1) Examples of appropriate data and § 570.30(a) and (c)); information include the chemical (6) State your view that the notified name, applicable registry numbers substance is not subject to the pre- (such as a Chemical Abstracts Service market approval requirements of the (CAS) registry number or an Enzyme Federal Food, Drug, and Cosmetic Act Commission (EC) number), empirical based on your conclusion that the noti- formula, structural formula, quan- fied substance is GRAS under the con- titative composition, and char- ditions of its intended use; acteristic properties. (7) State that, if we ask to see the (2) When the source of a notified sub- data and information that are the basis stance is a biological material, you for your conclusion of GRAS status, ei- must include data and information suf- ther during or after our evaluation of ficient to identify: (i) The taxonomic source ( genus, your notice, you will: e.g., species), including as applicable data (i) Agree to make the data and infor- and information at the sub-species mation available to us; and level (e.g., variety, strain); (ii) Agree to both of the following (ii) The part of any plant or animal procedures for making the data and in- used as the source; and formation available to us: (iii) Any known toxicants that could (A) Upon our request, you will allow be in the source; us to review and copy the data and in- (b) A description of the method of formation during customary business manufacture of the notified substance hours at the address you specify for in sufficient detail to evaluate the where these data and information will safety of the notified substance as be available to us; and manufactured; (B) Upon our request, you will pro- (c) Specifications for material that is vide us with a complete copy of the of appropriate grade for use in animal data and information either in an elec- food; and tronic format that is accessible for our (d) When necessary to demonstrate evaluation or on paper; safety, relevant data and information (8) State your view as to whether any bearing on the physical or other technical effect the notified substance is of the data and information in Parts 2 intended to produce, including the through 7 of your GRAS notice are ex- quantity of the notified substance re- empt from disclosure under the Free- quired to produce such effect. dom of Information Act, 5 U.S.C. 552 (e.g., as trade secret or as commercial § 570.235 Part 3 of a GRAS notice: Tar- or financial information that is privi- get animal and human exposures. leged or confidential); In part 3 of your GRAS notice, you (9) Certify that, to the best of your must provide data and information knowledge, the GRAS notice is a com- about exposure to the target animal plete, representative, and balanced and to humans consuming human food submission that includes unfavorable derived from food-producing animals, information, as well as favorable infor- regardless of whether your conclusion mation, known to you and pertinent to of GRAS status is through scientific the evaluation of the safety and GRAS procedures or through experience based status of the use of the substance; and on common use in food, as follows:

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(a) For exposure to the target ani- added to animal food is limited because mal, you must provide: animal food containing levels of the (1) The amount of the notified sub- notified substance above a particular stance that different target animal spe- level would become unpalatable or cies are likely to consume in the ani- technologically impractical, in Part 4 mal food (including drinking water) as of your GRAS notice you must include part of the animal’s total diet, includ- data and information on such self-lim- ing the intended use and all other iting levels of use. sources in the total diet; and (2) When applicable, the amount of § 570.245 Part 5 of a GRAS notice: Ex- any other substance that is expected to perience based on common use in be formed in or on food because of the food before 1958. use of the notified substance (e.g., If the statutory basis for your con- hydrolytic products or reaction prod- clusion of GRAS status is through ex- ucts); perience based on common use in ani- (3) When applicable, the amount of mal food, in Part 5 of your GRAS no- any other substance that is present tice you must include evidence of a with the notified substance either nat- substantial history of consumption of urally or due to its manufacture (e.g., the notified substance for food use by a contaminants or by-products); significant number of animals of the (4) The data and information you rely species to which the substance is in- on to establish the amount of the noti- tended to be fed prior to January 1, fied substance and the amounts of any 1958, and evidence of a substantial his- other substance in accordance with tory of consumption by humans con- paragraphs (a)(1) through (a)(3) of this suming human foods derived from food- section that different target animal producing animals prior to January 1, species are likely to consume in the 1958. animal food (including drinking water) as part of the animal’s total diet; and § 570.250 Part 6 of a GRAS notice: Nar- (b) When the intended use is in food rative. for food-producing animals, you must In Part 6 of your GRAS notice, you provide: must include a narrative that provides (1) The potential quantities of any the basis for your conclusion of GRAS residues that humans may be exposed status, in which: to in edible animal tissues, including: (a)(1) You must explain why the data (i) Residues of the notified substance; and information in your notice provide (ii) Residues of any other substance a basis for your view that the notified that is expected to be formed in or on substance is safe under the conditions the animal food because of the use of of its intended use for both the target the notified substance; and animal and for humans consuming (iii) Residues from any other subhuman food derived from food-pro- stance that is present with the notified ducing animals. In your explanation, substance whether naturally, due to its you must address the safety of the no- manufacture (e.g., contaminants or by- tified substance, considering all animal products), or produced as a metabolite food (including drinking water) as part in edible animal tissues when the noti- of the animal’s total diet, taking into fied substance is consumed by a food- account any chemically or pharma- producing animal; and cologically related substances in such (2) The data and information you rely diet. In your explanation, you must on to establish, in accordance with also address the safety of the notified paragraph (b)(1) of this section, the po- substance in regard to human expo- tential quantities of any residues that sure, considering all dietary sources humans may be exposed to in edible and taking into account any chemi- animal tissues. cally or pharmacologically related substances; § 570.240 Part 4 of a GRAS notice: Self- (2) In your explanation, you must limiting levels of use. identify what specific data and infor- In circumstances where the amount mation that you discuss in accordance of the notified substance that can be with paragraph (a)(1) of this section are

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generally available, and what specific with paragraph (a) of this section are data and information that you discuss generally available, and which data in accordance with paragraph (a)(1) of and information are not generally this section are not generally avail- available. able, by providing citations to the list of data and information that you in- § 570.260 Steps you may take before clude in Part 7 of your GRAS notice in FDA responds to your GRAS notice. accordance with § 570.255; (a) You may submit a timely amend- (b) You must explain how the gen- ment to your filed GRAS notice, to up- erally available data and information date your GRAS notice or in response that you rely on to establish safety in to a question from us, before we re- accordance with paragraph (a) of this spond to your notice by letter in ac- section provide a basis for your conclu- cordance with § 570.265(b)(1) or cease to sion that the notified substance is gen- evaluate your notice in accordance erally recognized, among qualified ex- with § 570.265(b)(3). perts, to be safe under the conditions of (b) At any time before we respond to its intended use for both the target your notice by letter in accordance animal and for humans consuming with § 570.265(b)(1), you may request in human food derived from food-pro- writing that we cease to evaluate your ducing animals; GRAS notice. Your request does not (c) You must either: preclude you from submitting a future (1) Identify, discuss, and place in con- GRAS notice in accordance with this text, data and information that are, or subpart with respect to the notified may appear to be, inconsistent with substance. your conclusion of GRAS status, regardless of whether those data and in- § 570.265 What FDA will do with a formation are generally available; or GRAS notice. (2) State that you have reviewed the (a)(1) We will conduct an initial eval- available data and information and are uation of your submission to determine not aware of any data and information whether to file it as a GRAS notice for that are, or may appear to be, incon- evaluation of your view that the noti- sistent with your conclusion of GRAS fied substance is GRAS under the con- status; ditions of its intended use. (d) If you view any of the data and in- (2) If we file your submission as a formation in your notice as exempt GRAS notice, we will send you a letter from disclosure under the Freedom of that informs you of the date of filing. Information Act, you must identify the (3) If we do not file your submission specific data and information; and as a GRAS notice, we will send you a (e) For non-public, safety-related letter that informs you of that fact and data and information considered in provide our reasons for not filing the reaching a conclusion of GRAS status, submission as a GRAS notice. you must explain how there could be a (4) We will consider any timely basis for a conclusion of GRAS status amendment that you submit to a filed if qualified experts do not have access GRAS notice, to update your GRAS no- to such data and information. tice or in response to a question from us, before we respond to you by letter § 570.255 Part 7 of a GRAS notice: List in accordance with paragraph (b)(1) of of supporting data and information this section, if we deem that doing so is in your GRAS notice. feasible within the timeframes estab- (a) In part 7 of your GRAS notice, lished in paragraph (b) of this section. you must include a list of all of the If we deem that considering your data and information that you discuss amendment is not feasible within the in Part 6 of your GRAS notice to pro- timeframes established in paragraph vide a basis for your view that the no- (b) of this section or if we have granted tified substance is safe under the condi- your request to cease to evaluate your tions of its intended use as described in notice, we will inform you that we are accordance with § 570.250(a)(1). not considering your amendment. (b) You must specify which data and (b)(1) Within 180 days of filing, we information that you list in accordance will respond to you by letter based on

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our evaluation of your notice. We may PART 571—FOOD ADDITIVE extend the 180 day timeframe by 90 PETITIONS days on an as needed basis. (2) If we extend the timeframe, we Subpart A—General Provisions will inform you in writing of the extension as soon as practicable but no later Sec. than within 180 days of filing. 571.1 Petitions. 571.6 Amendment of petition. (3) If you ask us to cease to evaluate 571.7 Withdrawal of petition without preju- your GRAS notice in accordance with dice. § 570.260(b), we will send you a letter informing you of our decision regarding Subpart B—Administrative Actions on your request. Applications (c) If circumstances warrant, we will 571.100 Regulation based on petition. send you a subsequent letter about the 571.102 Effective date of regulation. notice. 571.110 Procedure for objections and hearings. § 570.275 Public disclosure of a GRAS 571.115 Application of the cancer clause of notice. section 409 of the act. (a) The data and information in a 571.130 Procedure for amending and repealing tolerances or exemptions from toler- GRAS notice (including data and infor- ances. mation submitted in any amendment or supplement to your GRAS notice, or AUTHORITY: 21 U.S.C. 321, 342, 348, 371; 42 incorporated into your GRAS notice) U.S.C. 241. are: SOURCE: 41 FR 38647, Sept. 10, 1976, unless (1) Considered a mandatory, rather otherwise noted. than voluntary, submission for purposes of their status under the Free- Subpart A—General Provisions dom of Information Act and our public information requirements in part 20 of § 571.1 Petitions. this chapter; and (a) Petitions to be filed with the (2) Available for public disclosure in Commissioner under the provisions of accordance with part 20 of this chapter section 409(b) of the act shall be sub- as of the date that we receive your mitted in triplicate. If any part of the GRAS notice. material submitted is in a foreign lan- (b) We will make the following read- guage, it shall be accompanied by an ily accessible to the public: accurate and complete English trans- (1) A list of filed GRAS notices, in- lation. The petition shall state peti- cluding the information described in tioner’s post office address to which § 570.225(c)(2) through (c)(5); published notices or orders issued or (2) The text of any letter that we objections filed pursuant to section 409 issue under § 570.265(b)(1) or (c); and of the act may be sent. (b) Pertinent information may be in- (3) The text of any letter that we corporated in, and will be considered as issue under § 570.265(b)(3) if we grant part of, a petition on the basis of spe- your request that we cease to evaluate cific reference to such information sub- your notice. mitted to and retained in the files of (c) We will disclose all remaining the Food and Drug Administration. data and information that are not ex- However, any reference to unpublished empt from public disclosure in accord- information furnished by a person ance with part 20 of this chapter. other than the applicant will not be considered unless use of such informa- § 570.280 Submission of a supplement. tion is authorized in a written state- If circumstances warrant, you may ment signed by the person who sub- submit a supplement to a filed GRAS mitted it. Any reference to published notice after we respond to your notice information offered in support of a by letter in accordance with food-additive petition should be accom- § 570.265(b)(1) or cease to evaluate your panied by reprints or photostatic cop- notice in accordance with § 570.265(b)(3). ies of such references.

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(c) Petitions shall include the fol- If the petitioner does not himself perform lowing data and be submitted in the all the manufacturing, processing, and pack- following form: ing operations for a food additive, the petition shall identify each person who will per- (Date) form a part of such operations and designate Name of petitioner lllllllllllll the part. Post office address lllllllllllll The petition shall include stability data, Date lllllllllllllllllllll and, if the data indicate that it is needed to Name of food additive and proposed use ll ensure the identity, strength, quality, or purity of the additive, the expiration date that will be employed. B. The amount of the food additive pro- Food and Drug Administration posed for use and the purposes for which it is CENTER FOR VETERINARY MEDICINE, proposed, together with all directions, rec- Director, Division of Animal Feeds (HFV–220), ommendations, and suggestions regarding 7500 Standish Pl., Rockville, MD 20855. the proposed use, as well as specimens of the DEAR SIRS: The undersigned, llll labeling proposed for the food additive and any labeling that will be required by applica- submits this petition pursuant to section ble provisions of the Federal Food, Drug, and 409(b)(1) of the Federal Food, Drug, and Cosmetic Act on the finished food by reason Cosmetic Act with respect to llllllll of the use of the food additive. If the additive results or may reasonably be expected to re- (Name of the food additive and proposed use) sult from the use of packaging material, the Attached hereto, in triplicate, and consti- petitioner shall show how this may occur tuting a part of this petition, are the fol- and what residues may reasonably be antici- lowing: pated. A. The name and all pertinent information (Typewritten or other draft-labeling copy concerning the food additive, including will be accepted for consideration of the pe- chemical identity and composition of the tition, provided a statement is made that food additive, its physical, chemical, and bi- final printed labeling identical in content to ological properties, and specifications pre- the draft copy will be submitted as soon as scribing the minimum content of the desired available and prior to the marketing of the component(s) and identifying and limiting food additive. the reaction byproducts and other impuri- If the food additive is one for which a tol- ties. Where such information is not avail- erance limitation is required to assure its able, a statement as to the reasons why it is safety, the level of use proposed should be no not should be submitted. higher than the amount reasonably required When the chemical identity and composi- to accomplish the intended physical or other tion of the food additive is not known, the technical effect, even though the safety data petition shall contain information in suffi- may support a higher tolerance.) cient detail to permit evaluation regarding the method of manufacture and the analyt- C. Data establishing that the food additive ical controls used during the various stages will have the intended physical or other of manufacturing, processing, or packing of technical effect or that it may reasonably be the food additive which are relied upon to es- expected to become a component, or to affect tablish that it is a substance of reproducible the characteristics, directly or indirectly, of composition. Alternative methods and con- food and the amount necessary to accom- trols and variations in methods and controls plish this. These data should include infor- within reasonable limits that do not affect mation in sufficient detail to permit evalua- the characteristics of the substance or the tion with control data. reliability of the controls may be specified. D. A description of practicable methods to If the food additive is a mixture of chemi- determine the amount of the food additive in cals, the petition shall supply a list of all the raw, processed, and/or finished food and substances used in the synthesis, extraction, of any substance formed in or on such food or other method of preparation, regardless of because of its use. The test proposed shall be whether they undergo chemical change in one that can be used for food-control pur- the process. Each substance should be identi- poses and that can be applied with consistent fied by its common English name and com- results by any properly equipped and trained plete chemical name, using structural for- laboratory personnel. mulas when necessary for specific identifica- E. Full reports of investigations made with tion. If any proprietary preparation is used respect to the safety of the food additive. as a component, the proprietary name should (A petition may be regarded as incomplete be followed by a complete quantitative unless it includes full reports of adequate statement of composition. Reasonable alter- tests reasonably applicable to show whether natives for any listed substance may be spec- or not the food additive will be safe for its ified. intended use. The reports ordinarily should

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include detailed data derived from appro- (g) A petition shall be retained but priate animal and other biological experi- shall not be filed if any of the data pre- ments in which the methods used and the re- scribed by section 409(b) of the act are sults obtained are clearly set forth. The peti- lacking or are not set forth so as to be tion shall not omit without explanation any reports of investigations that would bias an readily understood. evaluation of the safety of the food additive.) (h)(1) The following data and infor- F. Proposed tolerances for the food addi- mation in a food additive petition are tive, if tolerances are required in order to en- available for public disclosure, unless sure its safety. A petitioner may include a extraordinary circumstances are proposed regulation. shown, after the notice of filing of the G. If submitting petition to modify an existing regulation issued pursuant to section petition is published in the FEDERAL 409(c)(1)(A) of the act, full information on REGISTER or, if the petition is not each proposed change that is to be made in promptly filed because of deficiencies the original regulation must be submitted. in it, after the petitioner is informed The petition may omit statements made in that it will not be filed because of the the original petition concerning which no deficiencies involved: change is proposed. A supplemental petition (i) All safety and functionality data must be submitted for any change beyond the variations provided for in the original and information submitted with or in- petition and the regulation issued on the corporated by reference in the petition. basis of the original petition. (ii) A protocol for a test or study, un- H. The petitioner is required to submit ei- less it is shown to fall within the ex- ther a claim for categorical exclusion under emption established for trade secrets § 25.30 or § 25.32 of this chapter or an environ- and confidential commercial informa- mental assessment under § 25.40 of this chap- tion in § 20.61 of this chapter. ter. Yours very truly, (iii) Adverse reaction reports, prod- Petitioner llll uct experience reports, consumer com- By llll plaints, and other similar data and in- (Indicate authority) formation, after deletion of: (d) The petitioner will be notified of (a) Names and any information that the date on which his petition is filed, would identify the person using the and an incomplete petition, or one that product. has not been submitted in triplicate, (b) Names and any information that will usually be retained but not filed as would identify any third party involved a petition under section 409 of the act. with the report, such as a physician or The petitioner will be notified in what hospital or other institution. respects his petition is incomplete. (iv) A list of all ingredients contained (e) The petition must be signed by in a food additive, whether or not it is the petitioner or by his attorney or in descending order of predominance. A agent, or (if a corporation) by an au- particular ingredient or group of ingre- thorized official. dients shall be deleted from any such (f) The data specified under the sev- list prior to public disclosure if it is eral lettered headings should be sub- shown to fall within the exemption es- mitted on separate sheets or sets of tablished in § 20.61 of this chapter, and sheets, suitably identified. If such data a notation shall be made that any such have already been submitted with an ingredient list is incomplete. earlier application, the present peti- (v) An assay method or other analyt- tion may incorporate it by specific ref- ical method, unless it serves no regu- erence to the earlier. If part of the data latory or compliance purpose and is have been submitted by the manufac- shown to fall within the exemption es- turer of the food additive as a master tablished in § 20.61 of this chapter. file, the petitioner may refer to the (2) The following data and informa- master file if and to the extent he ob- tion in a food additive petition are not tains the manufacturer’s written per- available for public disclosure unless mission to do so. The manufacturer they have been previously disclosed to may authorize specific reference to the the public as defined in § 20.81 of this data without disclosure to the peti- chapter or they relate to a product or tioner. Nothing herein shall prevent ingredient that has been abandoned reference to published data. and they no longer represent a trade

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secret or confidential commercial or fi- the proposal in general terms. In the nancial information as defined in § 20.61 case of a food additive which becomes a of this chapter: component of food by migration from (i) Manufacturing methods or proc- packaging material, the notice shall esses, including quality control proce- include the name of the migratory sub- dures. stance, and where it is different from (ii) Production, sales, distribution, that of one of the original components, and similar data and information, ex- the name of the parent component, the cept that any compilation of such data maximum quantity of the migratory and information aggregated and pre- substance that is proposed for use in pared in a way that does not reveal food, and the physical or other tech- data or information which is not avail- nical effect which the migratory sub- able for public disclosure under this stance or its parent component is in- provision is available for public disclo- tended to have in the packaging mate- sure. rial. A copy of the notice will be (iii) Quantitative or semiquantita- mailed to the petitioner when the tive formulas. original is forwarded to the FEDERAL (3) All correspondence and written REGISTER for publication. summaries of oral discussions relating (j) The Commissioner may request a to a food additive petition are avail- full description of the methods used in, able for public disclosure in accordance and the facilities and controls used for, with the provisions of part 20 of this the production of the food additive, or chapter when the food additive regula- a sample of the food additive, articles tion is published in the FEDERAL REG- used as components thereof, or of the ISTER. food in which the additive is proposed (4) For purposes of this regulation, to be used, at any time while a petition safety and functionality data include is under consideration. The Commis- all studies and tests of a food additive sioner shall specify in the request for a on animals and humans and all studies sample of the food additive, or articles and tests on a food additive for iden- used as components thereof, or of the tity, stability, purity, potency, per- food in or on which the additive is pro- formance, and usefulness. posed to be used, a quantity deemed (i)(1) Within 15 days after receipt, the adequate to permit tests of analytical Commissioner will notify the peti- methods to determine quantities of the tioner of acceptance or nonacceptance food additive present in foods for which of a petition, and if not accepted the it is intended to be used or adequate reasons therefor. If accepted, the date for any study or investigation reason- of the notification letter sent to peti- ably required with respect to the safety tioner becomes the date of filing for of the food additive or the physical or the purposes of section 409(b)(5) of the technical effect it produces. The date act. If the petitioner desires, he may used for computing the 90-day limit for supplement a deficient petition after the purposes of section 409(c)(2) of the being notified regarding deficiencies. If act shall be moved forward 1 day for the supplementary material or expla- each day after the mailing date of the nation of the petition is deemed ac- request taken by the petitioner to sub- ceptable, petitioner shall be notified. mit the sample. If the information or The date of such notification becomes sample is requested a reasonable time the date of filing. If the petitioner does in advance of the 180 days, but is not not wish to supplement or explain the submitted within such 180 days after petition and requests in writing that it filing of the petition, the petition will be filed as submitted, the petition shall be considered withdrawn without prej- be filed and the petitioner so notified. udice. The date of such notification becomes (k) If nonclinical laboratory studies the date of filing. are involved, petitions filed with the (2) The Commissioner will publish in Commissioner under section 409(b) of the FEDERAL REGISTER within 30 days the act shall include, with respect to from the date of filing of such petition, each study, either a statement that the a notice of the filing, the name of the study was conducted in compliance petitioner, and a brief description of with the requirements set forth in part

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58 of this chapter, or, if the study was a future filing. Upon refiling the time not conducted in compliance with such limitation will begin to run anew. regulations, a brief statement of the reason for the noncompliance. Subpart B—Administrative Actions [41 FR 38647, Sept. 10, 1976, as amended at 42 on Applications FR 15675, Mar. 22, 1977; 50 FR 7518, Feb. 22, 1985; 50 FR 16668, Apr. 26, 1985; 52 FR 8583, § 571.100 Regulation based on petition. Mar. 19, 1987; 57 FR 6476, Feb. 25, 1992; 62 FR 40600, July 29, 1997] (a) The Commissioner will forward for publication in the FEDERAL REG- § 571.6 Amendment of petition. ISTER, within 90 days after filing of the petition (or within 180 days if the time After a petition has been filed, the is extended as provided for in section petitioner may submit additional in- 409(c)(2) of the act), a regulation pre- formation or data in support thereof. In such cases, if the Commissioner describing the conditions under which termines that the additional informa- the food additive may be safely used tion or data amounts to a substantive (including, but not limited to, speci- amendment, the petition as amended fications as to the particular food or will be given a new filing date, and the classes of food in or on which such ad- time limitation will begin to run anew. ditive may be used, the maximum If nonclinical laboratory studies are in- quantity that may be used or per- volved, additional information and mitted to remain in or on such food, data submitted in support of filed peti- the manner in which such additive may tions shall include, with respect to be added to or used in or on such food, each such study, either a statement and any directions or other labeling or that the study was conducted in com- packaging requirements for such addi- pliance with the requirements set forth tive deemed necessary by him to assure in part 58 of this chapter, or, if the the safety of such use), and prior to the study was not conducted in compliance forwarding of the order to the FEDERAL with such regulations, a brief state- REGISTER for publication shall notify ment of the reason or the noncompli- the petitioner of such order and the ance. reasons for such action; or by order [41 FR 38647, Sept. 10, 1976, as amended at 50 deny the petition, and shall notify the FR 7518, Feb. 22, 1985; 50 FR 16668, Apr. 26, petitioner of such order and of the rea- 1985] sons for such action. (b) If the Commissioner determines § 571.7 Withdrawal of petition without that additional time is needed to study prejudice. and investigate the petition, he shall (a) In some cases the Commissioner by written notice to the petitioner ex- will notify the petitioner that the peti- tend the 90-day period for not more tion, while technically complete, is in- than 180 days after the filing of the pe- adequate to justify the establishment tition. of a regulation or the regulation requested by petitioner. This may be due § 571.102 Effective date of regulation. to the fact that the data are not suffi- A regulation published in accordance ciently clear or complete. In such with § 571.100(a) shall become effective cases, the petitioner may withdraw the upon publication in the FEDERAL REG- petition pending its clarification or the ISTER. obtaining of additional data. This withdrawal will be without prejudice to a § 571.110 Procedure for objections and future filing. Upon refiling, the time hearings. limitation will begin to run anew from the date of refiling. Objections and hearings relating to food additive regulations under section (b) At any time before the order pro- 409(c), (d), or (h) of the act shall be gov- vided for in § 571.100(a) has been for- erned by part 12 of this chapter. warded to the FEDERAL REGISTER for publication, the petitioner may with- [42 FR 4717, Jan. 25, 1977, as amended at 42 draw the petition without prejudice to FR 15676, Mar. 22, 1977]

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§ 571.115 Application of the cancer 573.240 Calcium periodate. clause of section 409 of the act. 573.260 Calcium silicate. 573.280 Feed-grade calcium stearate and so- Food additives intended for use as an dium stearate. ingredient in food for animals that are 573.300 Choline xanthate. raised for food production and that 573.304 Chromium propionate. have the potential to contaminate 573.310 Crambe meal, heat toasted. human food with residues whose con- 573.320 Diammonium phosphate. 573.340 Diatomaceous earth. sumption could present a risk of cancer 573.360 Disodium EDTA. to people must satisfy the require- 573.380 Ethoxyquin in animal feeds. ments of subpart E of part 500 of this 573.400 Ethoxyquin in certain dehydrated chapter. forage crops. 573.420 Ethyl cellulose. [52 FR 49588, Dec. 31, 1987] 573.440 Ethylene dichloride. 573.450 Fermented ammoniated condensed § 571.130 Procedure for amending and whey. repealing tolerances or exemptions 573.460 Formaldehyde. from tolerances. 573.480 Formic acid. (a) The Commissioner, on his own 573.490 Gamma-linolenic acid safflower initiative or on the petition of any in- meal. terested person, pursuant to part 10 of 573.492 Gamma-linolenic acid safflower oil. 573.496 Guanidinoacetic acid. this chapter, may propose the issuance 573.500 Condensed, extracted glutamic acid of a regulation amending or repealing a fermentation product. regulation pertaining to a food additive 573.520 Hemicellulose extract. or granting or repealing an exception 573.530 Hydrogenated corn syrup. for such additive. 573.540 Hydrolyzed leather meal. (b) Any such petition shall include an 573.560 Iron ammonium citrate. assertion of facts, supported by data, 573.580 Iron-choline citrate complex. 573.600 Lignin sulfonates. showing that new information exists 573.620 Menadione dimethylpyrimidinol bi- with respect to the food additive or sulfite. that new uses have been developed or 573.625 Menadione nicotinamide bisulfite. old uses abandoned, that new data are 573.637 Methyl esters of conjugated linoleic available as to toxicity of the chem- acid (cis-9, trans-11 and trans-10, cis-12- ical, or that experience with the exist- octadecadienoic acids). ing regulation or exemption may jus- 573.640 Methyl esters of higher fatty acids. 573.660 Methyl glucoside-coconut oil ester. tify its amendment or repeal. New data 573.680 Mineral oil. shall be furnished in the form specified 573.685 Natamycin. in § 571.1 for submitting petitions. 573.696 Feed grade sodium formate. 573.700 Sodium nitrite. [42 FR 4717, Jan. 25, 1977; 42 FR 15676, Mar. 22, 573.720 Petrolatum. 1977] 573.740 Odorless light petroleum hydro- carbons. PART 573—FOOD ADDITIVES PER- 573.750 Pichia pastoris dried yeast. MITTED IN FEED AND DRINKING 573.760 Poloxalene. 573.780 Polyethylene. WATER OF ANIMALS 573.800 Polyethylene glycol (400) mono- and dioleate. Subpart A [Reserved] 573.820 Polyoxyethylene glycol (400) mono- and dioleates. Subpart B—Food Additive Listing 573.840 Polysorbate 60. 573.860 Polysorbate 80. Sec. 573.870 Poly(2-vinylpyridine-co-styrene). 573.120 Acrylamide-acrylic acid resin. 573.880 Normal propyl alcohol. ′ 573.130 Aminoglycoside 3 -phospho- trans- 573.900 Pyrophyllite. ferase II. 573.914 Salts of volatile fatty acids. 573.140 Ammoniated cottonseed meal. 573.920 Selenium. 573.160 Ammoniated rice hulls. 573.940 Silicon dioxide. 573.170 Ammonium formate. 573.960 Sorbitan monostearate. 573.180 Anhydrous ammonia. 573.980 Taurine. 573.200 Condensed animal protein hydroly- 573.1000 Verxite. sate. 573.1010 Xanthan gum. 573.210 Benzoic acid. 573.1020 Yellow prussiate of soda. 573.220 Feed-grade biuret. 573.225 1,3-Butylene glycol. AUTHORITY: 21 U.S.C. 321, 342, 348.

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SOURCE: 41 FR 38652, Sept. 10, 1976, unless (c) The level of the additive does not otherwise noted. exceed the amount reasonably required for selection of plant cells carrying the Subpart A [Reserved] kanr gene along with the genetic material of interest. Subpart B—Food Additive Listing [59 FR 26711, May 23, 1994]

§ 573.120 Acrylamide-acrylic acid § 573.140 Ammoniated cottonseed resin. meal. Acrylamide-acrylic acid resin The food additive ammoniated cot- (hydrolized polyacrylamide), only for tonseed meal may be safely used in ac- the purposes of this section as de- cordance with the following conditions: scribed below, may be safely used in accordance with the following prescribed (a) The food additive is the product conditions: obtained by the treatment of cotton- (a) The additive is produced by po- seed meal with anhydrous ammonia lymerization of acrylamide with par- until a pressure of 50 pounds per square tial hydrolysis, or by copolymerization inch gauge is reached. of acrylamide and acrylic acid with the (b) It is used or intended for use in greater part of the polymer being com- the feed of ruminants as a source of posed of acrylamide units. protein and/or as a source of non- (b) The additive meets the following protein nitrogen in an amount not to specifications: exceed 20 percent of the total ration. (1) A minimum molecular weight of 3 (c) To assure safe use, the label and million. labeling of the additive and of any feed (2) Viscosity range: 3,000 to 6,000 cen- additive supplement, concentrate, or tipoises at 77 °F in a 1 percent aqueous premix prepared therefrom shall bear, solution as determined by LVF Brook- in addition to the other information re- field Viscometer or equivalent using a quired by the act, the following: number 6 spindle at 20 r.p.m. (1) The name of the additive. (3) Residual acrylamide: Not more (2) The maximum percentage of than 0.05 percent. equivalent crude protein from the non- (c) It is used as a thickener and sus- protein nitrogen. pending agent in nonmedicated aque- (3) Directions for use to provide not ous suspensions intended for addition more than 20 percent of the additive in to animal feeds. the total ration. [41 FR 38652, Sept. 10, 1976, as amended at 45 (4) A statement: FR 38058, June 6, 1980] (i) That not more than one-third of the total protein in the feed should § 573.130 Aminoglycoside 3′-phospho- come from nonprotein nitrogen transferase II. sources. The food additive aminoglycoside 3′- (ii) That the additive is not to be phosphotransferase II may be safely given to debilitated or starved animals. used in the development of genetically (iii) ‘‘Warning—This feed should be modified cotton, oilseed rape, and to- used only in accordance with directions matoes in accordance with the fol- furnished on the label.’’ lowing prescribed conditions: (a) The food additive is the enzyme [41 FR 38652, Sept. 10, 1976, as amended at 42 aminoglycoside 3′-phosphotransferase FR 52397, Sept. 30, 1977] II (CAS Reg. No. 58943–39–8) which cata- § 573.160 Ammoniated rice hulls. lyzes the phosphorylation of certain aminoglycoside antibiotics, including The food additive ammoniated rice kanamycin, neomycin, and gentamicin. hulls may be safely used in accordance (b) Aminoglycoside 3′- with the following prescribed condi- phosphotransferase II is encoded by the tions: kanr gene originally isolated from (a) The food additive is the product transposon Tn5 of the bacterium Esch- obtained by the treatment of ground erichia coli. rice hulls with monocalcium phosphate

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and anhydrous ammonia at a tempera- thoroughly mixed into complete swine ture of 350 °F and a pressure of 175 feeds and that the complete swine feeds pounds per square inch. so treated shall be labeled as con- (b) It is used or intended for use in taining ammonium formate. the feed of beef cattle as a source of (3) Cautions for use including this crude fiber and as the sole source of statement: Caution: Follow label direc- nonprotein nitrogen in an amount not tions. Formic acid and formate salts to exceed 20 percent of the total ration. from all added sources cannot exceed (c) To assure safe use of the additive, 1.2 percent of complete feed when mul- the label and labeling of the additive tiple sources of formic acid and its and of any feed additive supplement, salts are used in combination. feed additive concentrate, or feed addi- (e) To ensure safe use of the additive, tive premix prepared therefrom, shall in addition to the other information re- contain, in addition to other informa- quired by the Federal Food, Drug, and tion required by the act, the following: Cosmetic Act and paragraph (d) of this (1) The name of the additive. section, the label and labeling shall (2) The maximum percentage of contain: equivalent crude protein from the non- (1) Appropriate warnings and safety protein nitrogen. precautions concerning ammonium for- (3) Directions for use to provide not mate (37 percent ammonium salt of for- more than 20 percent of the additive in mic acid and 62 percent formic acid). the total ration, and a prominent (2) Statements identifying ammo- statement: ‘‘Warning—This feed should nium formate in formic acid (37 per- be used only in accordance with the di- cent ammonium salt of formic acid and rections furnished on the label.’’ 62 percent formic acid) as a corrosive and possible severe irritant. § 573.170 Ammonium formate. (3) Information about emergency aid The food additive, ammonium for- in case of accidental exposure as fol- mate, may be safely used in the manu- lows: facture of complete swine feeds in ac- (i) Statements reflecting require- cordance with the following prescribed ments of applicable sections of the conditions: Superfund Amendments and Reauthor- (a) The additive is manufactured by ization Act (SARA), and the Occupa- the reaction of 99.5 percent ammonia tional Safety and Health Administra- gas and 99 percent formic acid in a con- tion’s (OSHA) human safety guidance tinuous loop reactor to produce a solu- regulations. tion made up of 37 percent ammonium (ii) Contact address and telephone salt of formic acid and 62 percent for- number for reporting adverse reactions mic acid. or to request a copy of the Material (b) The additive is used or intended Safety Data Sheet (MSDS). for use as a feed acidifying agent, to [75 FR 41725, July 19, 2010, as amended at 78 lower the pH, in complete swine feeds FR 42692, July 17, 2013; 82 FR 52209, Nov. 13, at levels not to exceed 1.2 percent of 2017] the complete feed. (c) To ensure safe use of the additive, § 573.180 Anhydrous ammonia. formic acid and formate salts from all (a) The food additive anhydrous am- added sources cannot exceed 1.2 percent monia is applied directly to corn plant of complete feed when multiple sources material and thoroughly blended prior of formic acid and its salts are used in to ensiling. It is used or intended for combination. use as a source of nonprotein nitrogen (d) To assure safe use of the additive, in cattle feed in accordance with para- in addition to the other information re- graphs (a)(1), (2), or (3) as follows: quired by the Federal Food, Drug, and (1)(i) The food additive anhydrous Cosmetic Act (the act), the label and ammonia is applied as a component of labeling shall contain: an aqueous premix containing 16 to 17 (1) The name of the additive. percent ammonia, with molasses, min- (2) Adequate directions for use in- erals, and not less than 83 percent cluding a statement that ammonium crude protein. The premix is a source formate must be uniformly applied and of nonprotein nitrogen and minerals.

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(ii) In addition to the requirements of meat byproduct is hydrolyzed with paragraph (b) of this section, the label- heat and phosphoric acid. ing shall bear an expiration date of not (b) Specifications. The additive shall more than 10 weeks after date of manu- conform to the following percent-by- facture; a statement that additional weight specifications: protein should not be fed to lactating Moisture, not less than 45 percent nor more dairy cows producing less than 32 than 50 percent. pounds of milk per day nor beef cattle Protein, not less than 24 percent. consuming less than 1 percent of body Salt (NaCl), not more than 15 percent. weight daily in shelled corn; and a Phosphorus, not less than 2.25 percent. warning not to use additional trace (c) Uses. It is used or intended for use mineral supplementation with treated as a source of animal protein, phos- silage. phorus, and salt (NaCl) as follows: (2)(i) The food additive anhydrous (1) In poultry and swine feed in an ammonia is applied directly to corn amount not to exceed 5 percent by plant material for use in dairy or beef weight of the feed. cattle rations. (2) In feed concentrates for cattle in (ii) The anhydrous ammonia is ap- an amount not to exceed 10 percent by plied at a rate not to exceed the equiv- weight of the concentrate. alent of 0.35 percent of the corn plant (d) Labeling. The label and labeling material. shall bear, in addition to the other in- (iii) It is applied to corn plant mate- formation required by the act: rial containing 30 to 35 percent dry (1) The name of the additive, con- matter. densed animal protein hydrolysate. (iv) It is applied so that 75 to 85 per- (2) Adequate directions for use in- cent of the additive is liquid at ambi- cluding maximum quantities permitted ent pressure. for each species and a guaranteed anal- (3)(i) The food additive anhydrous ysis of the additive. ammonia is applied after being diluted to a 15 to 30 percent aqueous ammonia § 573.210 Benzoic acid. solution (by weight). The food additive, benzoic acid, may (ii) The anhydrous ammonia solution be safely used in the manufacture of is applied at a rate not to exceed anhy- complete swine feeds in accordance drous ammonia equivalent to 0.3 per- with the following prescribed condi- cent of the corn plant material. tions: (iii) It is applied to corn plant mate- (a) The additive is used or intended rial containing 28 to 38 percent dry for use as a feed acidifying agent, to matter. lower the pH, in complete swine feeds (iv) The silage treated with aqueous at levels not to exceed 0.5 percent of ammonia is to be fed to dairy cattle the complete feed. only. (b) The additive consists of not less (b) Its labeling shall bear, in addition than 99.5 percent benzoic acid (CAS 65– to the other requirements of the act, 85–0) by weight with the sum of 2- the name of the additive, the con- methylbiphenyl, 3-methylbiphenyl, 4- centration of ammonia, the maximum methylbiphenyl, benzyl benzoate, and percentage of equivalent crude protein isomers of dimethylbiphenyl not to ex- from nonprotein nitrogen, and direc- ceed 0.01 percent by weight. tions for use consistent with this sec- (c) To assure safe use of the additive, tion. in addition to the other information required by the Federal Food, Drug, and [44 FR 40284, July 10, 1979] Cosmetic Act and paragraph (b) of this section, the label and labeling shall § 573.200 Condensed animal protein contain: hydrolysate. (1) The name of the additive. (a) Identity. The condensed animal (2) Adequate directions for use in- protein hydrolysate is produced from cluding a statement that benzoic acid the meat byproducts scraped from must be uniformly applied and thor- cured (salted) hides taken from cattle oughly mixed into complete swine slaughtered for food consumption. The feeds and that the complete swine feeds

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so treated shall be labeled as con- accordance with the following pre- taining benzoic acid. scribed conditions: (3) Appropriate warnings and safety (a) It complies with the specifica- precautions concerning benzoic acid. tions in § 173.220(a) of this chapter. (4) A warning statement identifying (b) It is intended for use in swine feed benzoic acid as a possible irritant. as a source of energy. (5) Information about emergency aid (c) It is to be thoroughly mixed into in case of accidental exposure. feed at levels not to exceed 9 percent of (6) Contact address and telephone the dry matter of the total ration. number for reporting adverse reactions (d) 1,3-Butylene glycol should be or to request a copy of the Material mixed in feed with equipment adapted Safety Data Sheet (MSDS). for the addition of liquids, and the feed should be mixed not less than 5 min- [79 FR 14176, Mar. 13, 2014] utes after its addition. § 573.220 Feed-grade biuret. [53 FR 40061, Oct. 13, 1988] The food additive feed grade biuret § 573.240 Calcium periodate. may be safely used in ruminant feed in accordance with the following pre- The food additive calcium periodate scribed conditions: may be safely used in accordance with (a) The food additive is the product the following prescribed conditions: resulting from the controlled pyrolysis (a) The additive is produced by react- of urea conforming to the following ing calcium iodate with calcium hy- specifications: droxide or calcium oxide to form a substance consisting of not less than 60 Percent percent by weight of penta calcium orthoperiodate containing 28 to 31 per- Biuret ...... 55 minimum. Urea ...... 15 maximum. cent by weight of iodine. Cyanuric acid and triuret ...... 30 maximum. (b) It is used or intended for use in Mineral oil ...... 0.5 maximum. salt for livestock as a source of iodine. Total nitrogen (equivalent to 218.75 pct 35 minimum. crude protein). § 573.260 Calcium silicate. (b) It is used in ruminant feeds as a Calcium silicate, including synthetic source of nonprotein nitrogen. calcium silicate, may be safely used as (c) To assure safe use of the additive: an anticaking agent in animal feed, (1) The label and labeling of the addi- provided that the amount of calcium tive and that of any feed additive sup- silicate does not exceed 2 percent. plement, feed additive concentrate, § 573.280 Feed-grade calcium stearate feed additive premix, or complete feed and sodium stearate. prepared therefrom shall contain, in addition to other information required Feed-grade calcium stearate and so- by the act, the following: dium stearate may be safely used in an (i) The name of the additive. animal feed in accordance with the fol- (ii) The maximum percentage of lowing prescribed conditions: equivalent crude protein from non- (a) Feed-grade calcium stearate and protein nitrogen. sodium stearate are the calcium or so- (2) The label shall recommend that dium salts of a fatty acid mixture that the diet be balanced to provide ade- is predominately stearic acid. Associ- quate nutrients when equivalent crude ated fatty acids, including palmitic protein from all forms of nonprotein acid and minor amounts of lauric, nitrogen exceed one-third of the total myristic, pentadecanoic, margaric, crude protein in the total daily ration. arachidic, and other fatty acids may be contained in the mixture, but such as- [41 FR 38652, Sept. 10, 1976, as amended at 68 sociated fatty acids in aggregate do not FR 27904, May 22, 2003] exceed 35 percent by weight of the mixture. The fatty acids may be derived § 573.225 1,3-Butylene glycol. from feed-grade fats or oils. The food additive 1,3-butylene glycol (b) The additives meet the following (1,3-butanediol) may be safely used in specifications:

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(1) Unsaponifiable matter does not (1) It shall be incorporated into each exceed 2 percent. ton of complete feed by adding no less (2) They are free of chick-edema fac- than one pound of a premix containing tor. no more than 181.4 milligrams of added (c) The additives are manufactured so chromium from chromium propionate that in aqueous solution they are exper pound. posed for 1 hour or longer to tempera- (2) The premix manufacturer shall ture in excess of 180 °F. follow good manufacturing practices in (d) They are used as anticaking the production of chromium propionate agents in animal feeds in accordance premixes. Inventory, production, and with current good manufacturing prac- distribution records must provide a tices. complete and accurate history of prod- [63 FR 8573, Feb. 20, 1998] uct production. (3) Chromium from all sources of sup- § 573.300 Choline xanthate. plemental chromium cannot exceed 0.2 Choline xanthate may be safely used parts per million of the complete feed. as a component of animal feed as an (e) To assure safe use of the additive added source of choline to supplement in addition to the other information re- the diets of poultry, ruminants, and quired by the Federal Food, Drug, and swine in accordance with good feeding Cosmetic Act: practice. (1) The label and labeling of the additive, any feed premix, and complete § 573.304 Chromium Propionate. feed shall contain the name of the ad- The food additive chromium propio- ditive. nate may be safely used in animal feed (2) The label and labeling of the addi- as a source of supplemental chromium tive and any feed premix shall also con- in accordance with the following pre- tain: scribed conditions: (i) A guarantee for added chromium (a) The additive is manufactured by content. the reaction of a chromium salt with (ii) Adequate directions for use and propionic acid, at an appropriate stoi- cautions for use including this state- chiometric ratio, to produce triaqua- ment: Caution: Follow label directions. (mu3-oxo) hexakis (mu2-propionato- Chromium from all sources of supple- O,O′) trichromium propionate with the mental chromium cannot exceed 0.2 empirical formula, parts per million of the complete feed. [Cr3(O)(CH3CH2CO2)6(H2O)3]CH3CH2CO2. (b) The additive shall be incorporated [81 FR 35611, June 3, 2016] at a level not to exceed 0.2 milligrams § 573.310 Crambe meal, heat toasted. of chromium from chromium propionate per kilogram feed in broiler chick- (a) The additive is the seed meal of en complete feed. Crambe abyssinica obtained after the re- (c) The additive meets the following moval of oil from the seed and hull. specifications: The oil may be removed by pre-press (1) Total chromium content, 8 to 10 solvent extraction or by solvent ex- percent. traction alone. The resulting seed meal (2) Hexavalent chromium content, is heat toasted. less than 2 parts per million. (b) The additive conforms to the fol- (3) Arsenic, less than 1 part per mil- lowing percent-by-weight specifica- lion. tions: moisture, not more than 11 per- (4) Cadmium, less than 1 part per mil- cent; oil, not more than 4 percent; lion. crude protein, not less than 24 percent; (5) Lead, less than 0.5 part per mil- crude fiber, not more than 26 percent; lion. glucosinolate calculated as epi- (6) Mercury, less than 0.5 part per progoitrin, not more than 4 percent; million. goitrin, not more than 0.1 percent; (7) Viscosity, not more than 2,000 nitrile calculated as 1-cyano-2-hy- centipoise. droxy-3-butene, not more than 1.4 per- (d) The additive shall be incorporated cent. At least 50 percent of the nitro- into feed as follows: gen shall be soluble in 0.5 M sodium

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chloride. Myrosinase enzyme activity (b) Specifications. The additive shall shall be absent. conform to the following specifica- (c) The additive is used or intended tions: for use in the feed of feedlot cattle as Lead, not more than 15 parts per million. a source of protein in an amount not to Arsenic (as As), not more than 20 parts per exceed 4.2 percent of the total ration. million Fluorine, not more than 600 parts per mil- [46 FR 30082, June 5, 1981] lion. § 573.320 Diammonium phosphate. (c) Uses. It is used or intended for use as an inert carrier or anticaking agent The food additive diammonium phos- in animal feeds in an amount not to ex- phate may be safely used in ruminant ceed 2 percent by weight of the total feed in accordance with the following ration. prescribed conditions: (a) The food additive is the product § 573.360 Disodium EDTA. resulting from the neutralization of The food additive disodium EDTA feeding-phosphoric-acid or (disodium ethylenediaminetetraace- defluorinated wet-process phosphoric tate) may be safely used in animal acid with anhydrous ammonia. It con- feeds, in accordance with the following tains not less than 106.25 percent equiv- × prescribed conditions: alent crude protein (nitrogen 6.25) (a) The food additive contains a min- and 20 percent phosphorus. It contains imum of 99 percent disodium ethylene- not more than the following: diaminetetraacetate dihydrate 1 part fluorine to 100 parts phosphorus. (C10H14O8N2Na2 · 2H2O). 75 parts per million or arsenic (as As). (b) It is used to solubilize trace min- 30 parts per million of heavy metals, as lead erals in aqueous solutions, which are (Pb). then added to animal feeds. (c) It is used or intended for use in an (b) It is used in ruminant feeds as a amount not to exceed 240 parts per mil- source of phosphorus and nitrogen in lion of the additive in finished feed. an amount that supplies not more than (d) To assure safe use of the additive 2 percent of equivalent crude protein in the label and labeling shall bear: the total daily ration. (1) The name of the additive; and (c) To assure safe use of the additive, (2) Adequate mixing directions to en- the label and labeling of the additive sure that the chelated trace-mineral and that of any feed additive supple- mix is uniformly blended throughout ment, feed additive concentrate, feed the feed. additive premix, or complete feed prepared therefrom shall contain, in addi- § 573.380 Ethoxyquin in animal feeds. tion to other information required by Ethoxyquin (1,2-dihydro-6-ethoxy- the act, the following: 2,2,4-trimethylquinoline) may be safely (1) The name of the additive. used in animal feeds, when incor- (2) The maximum percentage of porated therein in accordance with the equivalent crude protein from the non- following prescribed conditions. protein nitrogen. (a) It is intended for use only: (1) As (3) If the feed additive premix, feed a chemical preservative for retarding additive concentrate, or feed additive oxidation of carotene, xanthophylls, supplement contains more than 2 per- and vitamins A and E in animal feed cent equivalent crude protein from and fish food and, (2) as an aid in pre- diammonium phosphate, adequate di- venting the development of organic rections for use and a prominent state- peroxides in canned pet food. ment, ‘‘Warning—This feed should be (b) The maximum quantity of the ad- used only in accordance with directions ditive permitted to be used and to re- furnished on the label.’’ main in or on the treated article shall not exceed 150 parts per million. § 573.340 Diatomaceous earth. (c) To assure safe use of the additive, (a) Identity. The additive consists of the label and labeling of the food addi- siliceous skeletal material derived tive container and that of any inter- from various species of diatoms. mediate premixes prepared therefrom

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shall contain, in addition to other in- only suitable animal or suitable vege- formation required by the act: table oil, prior to grinding and mixing. (1) The name of the additive, (d) The maximum quantity of the ad- ethoxyquin. ditive permitted to be used and to re- (2) A statement of the concentration main in or on the dehydrated forage or strength contained therein. crop shall not exceed 150 parts per mil- (3) Adequate use directions to provide lion. for a finished article with the proper (e) To assure the safe use of the addi- concentration of the additive as pro- tive, the label of the market package vided in paragraph (b) of this section, shall contain, in addition to other in- whether or not intermediate premixes formation required by the act: are to be used. (1) The name of the additive as speci- (d) The label of any animal feed con- fied in this section. taining the additive shall, in addition (2) Directions for the incorporation of to the other information required by the additive in the forage crops, as the act, bear the statement specified in paragraph (c) of this sec- ‘‘Ethoxyquin, a preservative’’ or tion, with the directive that only suit- ‘‘Ethoxyquin added to retard the able animal or suitable vegetable oils oxidative destruction of carotene, are to be used in the oil mix. xanthophylls, and vitamins A and E.’’ (f) The label of any dehydrated forage crops treated with the additive or the § 573.400 Ethoxyquin in certain dehy- label of an animal-feed supplement drated forage crops. containing such treated forage crops, Ethoxyquin (1,2-dihydro-6-ethoxy- shall, in addition to other information 2,2,4-trimethylquinoline) may be safely required by the act, bear the following used in the dehydrated forage crops statements: listed in paragraph (a) of this section (1) ‘‘Ethoxyquin, a preservative,’’ or when incorporated therein in accord- ‘‘Ethoxyquin added to retard the ance with the conditions prescribed in oxidative destruction of carotene and this section: vitamin E.’’ (a) It may be added to dehydrated (2) The statement ‘‘For use in animal forage prepared from: feed only.’’ Alfalfa ...... Medicago sativa. Barley ...... Hordeum vulgare. § 573.420 Ethyl cellulose. Clovers: Alsike clover ...... Trifolium hybridum. The food additive ethyl cellulose may Crimson clover ...... Trifolium incarnatum. be safely used in animal feed in accord- Red clover ...... Trifolium pratense. White clover (including La- Trifolium repens. ance with the following prescribed con- dino). ditions: White sweetclover ...... Melilotus alba. (a) The food additive is a cellulose Yellow sweetclover ...... Melilotus officinalis. Coastal Bermudagrass ...... Cynodon dactylon. ether containing ethoxy (OC2H5) groups Corn ...... Zea mays. attached by an ether linkage and con- Fescue ...... Festuca sp. taining on an anhydrous basis not more Oats ...... Avena sativa. than 2.6 ethoxy groups per Orchardgrass ...... Dactylis glomerata. Reed canarygrass ...... Pharlaris arundinacea. anhydroglucose unit. Ryegrass (annual and peren- Elymus sp. and Lolium (b) It is used or intended for use as a nial). perenne. binder or filler in dry vitamin prepara- Sorghums ...... Sorghum vulgare vars, fete- rita, shallu, kaoliang, tions to be incorporated into animal broomcorn. feed. Sudan grass ...... Sorghum vulgare sudanense. Wheat ...... Triticum aestivum. § 573.440 Ethylene dichloride. or any mixture of such forage crops, for The food additive ethylene dichloride use only as an animal feed. may be safely used in the manufacture (b) Such additive is used only as a of animal feeds in accordance with the chemical preservative for the purpose following prescribed conditions: of retarding oxidative destruction of (a) It is used as a solvent in the ex- naturally occurring carotenes and vita- traction processing of animal byprod- min E in the forage crops. ucts for use in animal feeds. (c) It is added to the dehydrated for- (b) The maximum quantity of the ad- age crops in an oil mixture containing ditive permitted to remain in or on the

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extracted byproducts shall not exceed § 573.460 Formaldehyde. 300 parts per million. The food additive formaldehyde may (c) The extracted animal byproduct is be safely used in the manufacture of added as a source of protein to a total animal feeds in accordance with the ration at levels consistent with good following conditions: feeding practices, but in no event at (a) The additive is used, or intended levels exceeding 13 percent of the total for use, to improve the handling char- ration. acteristics of fat by producing a dry, free-flowing product, as follows: § 573.450 Fermented ammoniated con- (1) For animal fat in combination densed whey. with certain oilseed meals, as a compo- (a) Identity. The product is produced nent of dry, nonpelletted feeds for beef by the Lactobacillus bulgaricus fer- and nonlactating dairy cattle. mentation of whey with the addition of (i) An aqueous blend of soybean and ammonia. sunflower meals in a ratio of 3:1, re- (b) Specifications. The product con- spectively, is mixed with animal fat tains 35 to 55 percent crude protein and such that the oilseed meals and animal not more than 42 percent equivalent fat are in a ratio of 3:2. The feed ingre- crude protein from nonprotein nitrogen dients are those defined by the ‘‘Offi- sources. cial Publication’’ of the Association of (c) Uses. The product is used as a American Feed Control Officials, Inc., source of protein and nonprotein nitro- 2003 ed., pp. 303, 308, and 309, which is gen for cattle. incorporated by reference. The Direc- (d) Limitations. (1) Store in a closed tor of the Office of the Federal Register vented tank equipped for agitation. approves this incorporation by ref- Agitate 5 minutes before using. Do not erence in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may ob- store at temperature above 110 °F (43 tain copies from the Assistant Sec- °C). retary-Treasurer, Association of Amer- (2) The maximum level of use of fer- ican Feed Control Officials Inc., P.O. mented ammoniated condensed whey Box 478, Oxford, IN 47971, or you may and equivalent crude protein from all examine a copy at the Division of other added forms of nonprotein nitro- Dockets Management, Food and Drug gen shall not exceed 30 percent of the Administration, 5630 Fishers Lane, rm. dietary crude protein. 1061, Rockville, MD 20852, or at the Na- (3) The additive may be used as fol- tional Archives and Records Adminis- lows: tration (NARA). For information on (i) Mixed with grain, roughage, or the availability of this material at grain and roughage prior to feeding. NARA, call 202–741–6030, or go to: http:// (ii) As a component of free-choice liq- www.archives.gov/federallregister/ uid feeds, used to supplement the diets codeloflfederallregulations/ of cattle fed other sources of nutrients, ibrllocations.html. fermented ammoniated condensed (ii) Formaldehyde (37 percent solu- whey shall not exceed 80 percent of the tion) is added to the mixture at a level free-choice liquid feed. of 4 percent of the dry matter weight of (e) Labeling. The label shall bear, in the oilseed meals and animal fat. This addition to other information required mixture, upon drying, contains not by the act: more than 1 percent formaldehyde and (1) The name of the additive. not more than 12 percent moisture. (iii) To assure the safe use of the ad- (2) The maximum percentage of ditive, in addition to the other infor- equivalent crude protein from non- mation required by the Federal Food, protein nitrogen. Drug, and Cosmetic Act (the act), the (3) Adequate directions for use in ac- label and labeling of the dried mixture cordance with the provisions in para- shall bear: graph (d) of this section. (A) The name of the additive. [43 FR 33708, July 1, 1978, as amended at 46 (B) Adequate directions for use pro- FR 49115, Oct. 6, 1981] viding that the feed as consumed does

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not contain more than 25 percent of the percent of the analyzed fat content for mixture. each batch. (2) For soybean and canola seeds and/ (b)(1) The food additive is formalde- or meals to which there may be added hyde (CAS No. 50–00–0; 37 percent aque- vegetable oil as a component of dry, ous solution). It is used at a rate of 5.4 nonpelleted feeds for beef and dairy pounds (2.5 kilograms) per ton of ani- cattle, including lactating dairy cattle. mal feed or feed ingredient. It is an (i) An aqueous blend of oilseed and/or antimicrobial agent used to maintain meals, with or without added vegetable complete animal feeds or feed ingredi- oil, in a ratio such that, on a dry mat- ents Salmonella negative for up to 21 ter basis, the final protein level will be days. 25 to 35 percent and the fat content will (2) To assure safe use of the additive, be 20 to 45 percent. The feed ingredi- in addition to the other information re- ents are those defined by the ‘‘Official quired by the Act, the label and label- Publication’’ of the Association of ing shall contain: American Feed Control Officials, Inc., (i) The name of the additive. 2003 ed., pp. 301, 307, 308, and 309, which (ii) A statement that formaldehyde is incorporated by reference. The Di- solution which has been stored below 40 rector of the Office of the Federal Reg- °F or allowed to freeze should not be ister approves this incorporation by applied to complete animal feeds or reference in accordance with 5 U.S.C. feed ingredients. 552(a) and 1 CFR part 51. You may ob- (iii) Adequate directions for use in- tain copies from the Assistant Sec- cluding a statement that formaldehyde retary-Treasurer, Association of Amer- should be uniformly sprayed on and ican Feed Control Officials Inc., P.O. thoroughly mixed into the complete Box 478, Oxford, IN 47971, or you may animal feeds or feed ingredients and examine a copy at the Division of that the complete animal feeds or feed Dockets Management, Food and Drug ingredients so treated shall be labeled Administration, 5630 Fishers lane, rm. as containing formaldehyde. The label 1061, Rockville, MD 20852, or at the Na- must prominently display the state- tional Archives and Records Adminis- ment: ‘‘Treated with formaldehyde to tration (NARA). For information on maintain feed Salmonella negative. Use the availability of this material at within 21 days.’’ NARA, call 202–741–6030, or go to: http:// (iv) The labeling for feed or feed in- www.archives.gov/federallregister/ gredients to which formaldehyde has codeloflfederallregulations/ been added under the provisions of ibrllocations.html. paragraph (b)(1) of this section is re- (ii) Formaldehyde (37 percent solu- quired to carry the following state- tion) is added to the mixture at a level ment: ‘‘Treated with formaldehyde to of 2.7 percent of the dry matter weight maintain feed Salmonella negative. Use basis of the oilseeds and/or meals and within 21 days.’’ the vegetable oil. This mixture, upon (3) To assure safe use of the additive, drying, contains not more than 0.5 per- in addition to the other information re- cent formaldehyde and not more than quired by the Act, the label and label- 12 percent moisture. ing shall contain: (iii) To assure the safe use of the ad- (i) Appropriate warnings and safety ditive, in addition to the other infor- precautions concerning formaldehyde. mation required by the act, the label (ii) Statements identifying formalde- and labeling of the dried mixture shall hyde as a poison with potentials for ad- bear: verse respiratory effects. (A) The name of the additive. (iii) Information about emergency (B) The statement, ‘‘This supplement aid in case of accidental inhalation. is not to exceed 12.5% of the total ra- (iv) Statements reflecting require- tion. Dietary calcium and magnesium ments of applicable sections of the levels should be considered when Superfund Amendments and Reauthor- supplementing the diet with fat.’’ ization Act (SARA), and the Occupa- (C) The minimum and maximum lev- tional Safety and Health Administra- els of crude fat must be guaranteed and tion’s (OSHA) human safety guidance must be between ¥5 percent and +5 regulations.

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(v) Contact address and phone num- tions. Formic acid and formate salts ber for reporting adverse reactions or from all added sources cannot exceed to request a copy of the Materials Safe- 1.2 percent of complete feed when mul- ty Data Sheet (MSDS). tiple sources of formic acid and its salts are used in combination. [41 FR 38652, Sept. 10, 1976, as amended at 54 FR 18281, Apr. 28, 1989; 61 FR 15704, Apr. 9, (5) To ensure safe use of the additive, 1996; 63 FR 53580, Oct. 6, 1998; 68 FR 65633, in addition to the other information re- Nov. 21, 2003] quired by the Federal Food, Drug, and Cosmetic Act and paragraph (b)(4) of § 573.480 Formic acid. this section, the label and labeling The food additive, formic acid, may shall contain: be safely used in accordance with the (i) Appropriate warnings and safety following conditions: precautions concerning formic acid (85 (a) The additive is used as a preserva- percent formic acid). tive in hay crop silage in an amount (ii) Statements identifying formic not to exceed 2.25 percent of the silage acid (85 percent formic acid) as a corro- on a dry weight basis or 0.45 percent sive and possible severe irritant. when direct cut, as follows: (iii) Information about emergency (1) The top foot of silage stored aid in case of accidental exposure. should not contain formic acid and (A) Statements reflecting require- (2) Silage should not be fed to live- ments of applicable sections of the stock within 4 weeks of treatment. Superfund Amendments and Reauthor- (b) The additive is used or intended ization Act (SARA), and the Occupa- for use as a feed acidifying agent, to tional Safety and Health Administra- lower the pH, in complete swine and tion’s (OSHA) human safety guidance poultry feeds at levels not to exceed 1.2 regulations. percent of the complete feed. (B) Contact address and telephone (1) The additive consists of not less number for reporting adverse reactions than 85 percent formic acid (CAS 64–18– or to request a copy of the Safety Data 6). Sheet (SDS). (2) The additive meets the following specifications: [76 FR 7106, Feb. 9, 2011, as amended at 82 FR (i) Free methyl alcohol not to exceed 52209, Nov. 13, 2017; 83 FR 20, Jan. 2, 2018] 1,000 parts per million (ppm); (ii) Methyl formate not to exceed § 573.490 Gamma-linolenic acid safflower meal. 1,000 ppm; and (iii) Moisture not to exceed 15 per- The food additive consists of the cent. meal obtained after the removal of (3) To ensure safe use of the additive, most of the oil from whole seeds or par- formic acid and formate salts from all tially dehulled seeds or both obtained added sources cannot exceed 1.2 percent from a Carthamus tinctorius L. safflower of complete feed when multiple sources Centennial variety genetically engi- of formic acid and its salts are used in neered to express the delta-6- combination. desaturase gene from Saprolegnia (4) To assure safe use of the additive, diclina Humphrey. The 453 amino acid, in addition to the other information re- delta-6-desaturase enzyme converts the quired by the Federal Food, Drug and fatty acid linoleic acid to gamma-lino- Cosmetic Act, the label and labeling lenic acid during seed development. shall contain: The resulting additive may be safely (i) The name of the additive. used in cattle and poultry feeds in ac- (ii) Adequate directions for use in- cordance with the following prescribed cluding a statement that formic acid conditions: must be uniformly applied and thor- (a) The additive shall contain not oughly mixed into complete swine less than 20 percent crude protein, not feeds and that the complete swine feeds more than 40 percent crude fiber, not so treated shall be labeled as con- more than 10 percent moisture, and not taining formic acid. more than 2 percent crude fat. (iii) Cautions for use including this (b) The crude fat in the additive statement: Caution: Follow label direc- meets the following specifications:

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(1) Gamma-linolenic acid content not specifications required for the additive to exceed 55 percent. or the blend in paragraph (a)(2) of this (2) Total content of stearidonic acid section. and cis, cis-6, 9-octadecadienoic acid (2) The additive or a safflower oil not to exceed a total of 0.5 percent. blend containing the additive for use in (3) Total content of palmitic, stearic, animal food meets the following speci- oleic, linoleic, and other associated fications: fatty acids to exceed a total of 40 per- (i) Crude fat content of the GLA saf- cent. flower oil or its blend is not less than (c) The additive is used or intended 99.5 percent. for use in cattle and poultry feeds as a (ii) GLA content is between 400 and source of protein in accordance with 450 milligrams (mg) GLA per gram of good manufacturing and feeding prac- the GLA safflower oil or its blend. tices. (iii) Total content of stearidonic acid (d) To assure safe use of the additive, and cis, cis-6,9-octadecadienoic acid in in addition to the other information re- the GLA safflower oil or its blend must quired by the Food, Drug, and Cos- not exceed a total of 0.3 percent. metic Act, the label and labeling of the (3) Addition of GLA safflower oil, or additive, any feed premix, or complete its blend, to complete dry adult main- feed shall bear the following: tenance dog food must meet the fol- (1) The name of the additive or the lowing: common name, safflower meal. (i) Addition of the oil or its blend (2) Adequate directions for use in cat- cannot provide more than 36 mg GLA tle and poultry feeds. per kilogram body weight of the dog (e) The additive may be identified by per day in more than 86 mg of the GLA the common or usual name, safflower safflower oil or its blend. This max- meal. imum addition rate of the GLA safflower oil, or its blend, is 0.3 percent of [80 FR 35569, June 22, 2015] a complete dry adult maintenance dog § 573.492 Gamma-linolenic acid saf- food containing 3,600 kilocalories of flower oil. metabolizable energy per kilogram of The food additive gamma-linolenic food as-fed. (ii) Adjustments must be made for acid (all-cis-6,9,12-octadecatrienoic dog food formulas of different caloric acid) (GLA) safflower oil contains an density and/or that are fed to specific omega-6 fatty acid that may be safely weights, breeds, or dogs of different ac- used in animal food in accordance with tivity levels to meet the requirements the following conditions: (a) The additive GLA safflower oil is of this paragraph. (b) To assure safe use of the additive, produced in the oil obtained from in addition to other information re- whole seeds or partially dehulled seeds quired by the Federal Food, Drug, and or both obtained from a Carthamus Cosmetic Act, the label and labeling of tinctorius L. safflower Centennial vari- the additive shall bear the following: ety genetically engineered to express (1) The name, gamma-linolenic acid the delta-6-desaturase gene from (GLA) safflower oil. Saprolegnia diclina Humphrey. The 453 (2) A guarantee for the minimum amino acid, delta-6-desaturase enzyme content of gamma-linolenic acid. converts the fatty acid linoleic acid to (3) Adequate directions for use such GLA during seed development. This that the finished animal food complies GLA safflower oil may be safely used in with the provisions of paragraph (a)(3) complete dry adult maintenance dog of this section. food as a source of GLA and other omega-6 fatty acids in accordance with [82 FR 38596, Aug. 15, 2017] the following prescribed conditions: (1) The GLA safflower oil obtained § 573.496 Guanidinoacetic acid. from the seeds of the genetically engi- The food additive, guanidinoacetic neered safflower Centennial variety acid, may be safely used in broiler may be blended with oil obtained from chicken and turkey feeds in accordance seeds of non-engineered oleic acid saf- with the following prescribed condi- flower varieties in order to meet the tions:

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(a) The additive is manufactured by (2) In cattle feed as a source of pro- reacting glycine with cyanamide in an tein in an amount not to exceed 10 per- aqueous solution. cent of the feed. (b) The additive is used or intended (c) In order to assure safe use, the for use to spare arginine and as a pre- label and labeling of the additive shall cursor of creatine in broiler chicken bear, in addition to the other informa- and turkey feeds at levels not to exceed tion required by the Act, the following: 0.12 percent of the complete feed. (1) The name of the additive. (c) The additive consists of not less (2) A statement of the concentration than 97 percent guanidinoacetic acid of the additive contained in any mix- [N-(aminoiminomethyl)-glycine] (CAS ture. 352–97–6) by weight. (3) Adequate directions for use. (d) The additive meets the following specifications: § 573.520 Hemicellulose extract. (1) Dicyandiamide not to exceed 0.5 Hemicellulose extract may be safely percent; used in animal feed when incorporated (2) Cyanamide not to exceed 0.01 per- therein in accordance with the fol- cent; lowing conditions: (3) Melamine not to exceed 15 parts (a) The additive is produced from the per million (ppm); aqueous extract obtained by the treat- (4) Sum of ammeline, ammelide, and ment of wood with water at elevated cyanuric acid not to exceed 35 ppm; and temperatures (325 degrees–535 degrees (5) Water not to exceed 1 percent. F) and pressure (80 to 900 pounds per (e) To assure safe use of the additive square inch) and contains primarily in addition to the other information re- pentose and hexose sugars. quired by the Federal Food, Drug, and (b) The additive may be used in a liq- Cosmetic Act: uid or dry state with the liquid product (1) The label and labeling of the addi- containing not less than 55 percent car- tive, any feed premix, and complete bohydrate and the dry product con- feed shall contain the name of the ad- taining not less than 84 percent carbo- ditive. hydrate. (2) The label and labeling of the addi- (c) The additive is used as a source of tive and any feed premix shall also con- metabolizable energy in animal feed in tain: accordance with good manufacturing (i) A statement to indicate that the and feeding practices. maximum use level of guanidinoacetic [41 FR 38652, Sept. 10, 1976, as amended at 43 acid must not exceed 0.12 percent of the FR 11181, Mar. 17, 1978] complete feed for broiler chickens and turkeys; and § 573.530 Hydrogenated corn syrup. (ii) Adequate directions for use. (a) Identity. The product is produced [81 FR 86269, Nov. 30, 2016] by hydrogenation of corn syrup over a nickel catalyst. § 573.500 Condensed, extracted glu- (b) Specifications. The product con- tamic acid fermentation product. tains 70 percent hydrogenated corn Condensed, extracted glutamic acid syrup and a maximum of 0.5 percent re- fermentation product may be safely ducing sugars. used in animal feed under the following (c) Uses. The product is used as a hu- conditions: mectant and plasticizer in preparation (a) The additive is a concentrated of soft-moist dog and cat foods. mixture of the liquor remaining from (d) Limitations. The product is pref- the extraction of glutamic acid, com- erably stored in a closed, stainless bined with the cells of Corynebacterium steel or aluminum container. The level lilium used to produce the glutamic of use of the product shall not exceed acid. 15 percent of the total weight of the pet (b) It is used or intended for use as food formulation. follows: (e) Labeling. The labeling shall bear, (1) In poultry feed as a source of pro- in addition to other information re- tein in an amount not to exceed 5 per- quired by the Act: cent of the total ration. (1) The name of the additive.

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(2) Adequate directions for use in ac- § 573.580 Iron-choline citrate complex. cordance with the provisions in para- Iron-choline citrate complex made by graph (d) of this section. reacting approximately equimolecular [45 FR 22920, Apr. 4, 1980] quantities of ferric hydroxide, choline, and citric acid may be safely used as a § 573.540 Hydrolyzed leather meal. source of iron in animal feed. (a) Identity. Hydrolyzed leather meal § 573.600 Lignin sulfonates. is produced from leather scraps that are treated with steam for not less Lignin sulfonates may be safely used than 33 minutes at a pressure of not in animal feeds in accordance with the less than 125 pounds per square inch. following prescribed conditions: (b) Specifications. The additive shall (a) For the purpose of this section, conform to the following percent-by- the food additive is either one, or a weight specifications: combination of, the ammonium, calcium, magnesium, or sodium salts of Moisture, not less than 5 percent nor more the extract of spent sulfite liquor de- than 10 percent. rived from the sulfite digestion of wood Crude protein, not less than 60 percent. or of abaca (Musa textilis) or of sisal Crude fat, not less than 5 percent. (Agave sisalana) in either a liquid form Crude fiber, not more than 6 percent. (moisture not to exceed 50 percent by Chromium, not more than 2.75 percent. weight) or dry form (moisture not to (c) Use. It is used or intended for use exceed 6 percent by weight). as a source of protein in swine feeds in (b) It is used or intended for use in an an amount not to exceed 1.0 percent by amount calculated on a dry weight weight of the finished feed. basis, as follows: (d) Labeling. The labels and labeling (1) As a pelleting aid in the liquid or shall bear, in addition to the other in- dry form in an amount not to exceed 4 formation required by the Act: percent of the finished pellets. (1) The name of the additive, (2) As a binding aid in the liquid form hydrolyzed leather meal. in the flaking of feed grains in an (2) Adequate directions to provide amount not to exceed 4 percent of the finished feeds complying with para- flaked grain. graph (c) of this section. (3) As a surfactant in molasses used in feeds, as liquid lignin sulfonate, in § 573.560 Iron ammonium citrate. an amount not to exceed 11 percent of the molasses. Iron ammonium citrate may be safe- (4) As a source of metabolizable en- ly used in animal feed in accordance ergy, in the liquid or dry form, in an with the following prescribed condi- amount not to exceed 4 percent of the tions: finished feed. (a) The additive is the chemical green ferric ammonium citrate. § 573.620 Menadione (b) The additive is used or intended dimethylpyrimidinol bisulfite. for use as an anticaking agent in salt The food additive, menadione for animal consumption so that the dimethylpyrimidinol bisulfite, may be level of iron ammonium citrate does safely used in accordance with the fol- not exceed 25 parts per million (0.0025 lowing conditions: percent) in the finished salt. (a) The additive is the 2-hydroxy-4,6- (c) To assure safe use of the additive dimethylpyrimidinol salt of menadione the label or labeling of the additive (C17H18O6N2S). shall bear, in addition to the other in- (b) The additive is used or intended formation required by the Act: for use as a nutritional supplement for (1) The name of the additive. the prevention of vitamin K deficiency (2) Adequate directions to provide a as follows: final product that complies with the (1) In chicken and turkey feed at a limitations prescribed in paragraph (b) level not to exceed 2 grams per ton of of this section. complete feed.

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(2) In the feed of growing and fin- (b) The additive is used or intended ishing swine at a level not to exceed 10 for use in the feed of growing and fin- grams per ton of feed. ishing swine as a source of fatty acids (c) To assure safe use, the label and at levels not to exceed 0.6% in the fin- labeling of the additive shall bear ade- ished feed. quate directions for use. (c) The additive meets the following specifications: § 573.625 Menadione nicotinamide bi- (1) Free methyl alcohol not to exceed sulfite. 0.015%. The food additive may be safely used (2) Insoluble impurities not to exceed as follows: 0.1%. (a) The additive is 1,2,3,4-tetrahydro- (3) Moisture not to exceed 0.5%. 2-methyl-1,4-dioxo-2-naphthalene sul- (4) Unsaponifiable matter not to ex- fonic acid with 3-pyridine carboxylic ceed 1.0%. acid amine (CAS No. 73581–79–0). (d) To assure safe use of the additive, (b) The additive is used or intended in addition to the other information re- for use as a nutritional supplement for quired by the act: both the prevention of vitamin K defi- (1) The label and labeling of the addi- ciency and as a source of supplemental tive and any feed premix shall bear the niacin as follows: following: (1) In chicken and turkey feeds at a (i) The name of the additive. level not to exceed 2 grams per ton of (ii) A statement to indicate that complete feed. methyl esters of conjugated linoleic (2) In growing and finishing swine acid (cis-9, trans-11 and trans-10, cis-12 feeds at a level not to exceed 10 grams octadecadienoic acids) must not be per ton of complete feed. added to vitamin or mineral premixes. (c) To assure safe use, the label and (2) The label and labeling of the addi- labeling of the additive shall bear ade- tive, any feed premix, or complete feed quate directions for use. prepared therefrom shall bear adequate directions for use. [64 FR 46840, Aug. 27, 1999] [73 FR 64198, Oct. 29, 2008] § 573.637 Methyl esters of conjugated linoleic acid (cis-9, trans-11 and § 573.640 Methyl esters of higher fatty trans-10, cis-12-octadecadienoic acids. acids). The food additive methyl esters of The food additive, methyl esters of higher fatty acids may be safely used conjugated linoleic acid (cis-9, trans-11 in animal feeds in accordance with the and trans-10, cis-12 octadecadienoic following prescribed conditions: acids), may be safely used in swine feed (a) The food additive is manufactured in accordance with the prescribed con- by reaction of methyl alcohol with ditions: feed-grade fats or oils and consists of (a) The food additive is manufactured not less than 70 percent methyl esters by the reaction of refined sunflower oil of the following straight-chain with methanol to produce fatty acid monocarboxylic acids: Docosahexanoic methyl esters, which then undergo con- acid, eicosapentanoic acid, linoleic jugation to yield methyl esters of octa- acid, myristic acid, oleic acid, palmitic decadienoic acid. The additive consists acid, palmitoleic acid, and stearic acid, of not less than 28 percent methyl ester and lesser amounts of the associated of cis-9, trans-11-octadecadienoic acid, acid esters. and not less than 28 percent methyl (b) The food additive meets the fol- ester of trans-10, cis-12-octadecadienoic lowing specifications: acid with the sum of the other methyl (1) Free methyl alcohol not to exceed esters of octadecadienoic acid not to 150 parts per million. exceed 4 percent. The additive shall (2) Unsaponifiable matter not to ex- contain not less than 35 percent of ceed 2 percent. other fatty acid esters composed of (3) It is free of chick-edema factor or oleic acid, palmitic acid, stearic acid, other factors toxic to chicks, as evi- linoleic acid, and other associated acid denced during the bioassay method for esters. determining the chick-edema factor as

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prescribed in paragraph (b)(4)(ii) of this xx− section. t = tc (4) For the purposes of this section: ()sn22+ () sn (i) Unsaponifiable matter shall be de- tt// cc termined by the method described in where: Section 28.081, ‘‘Unsaponifiable Residue x¯ t and x¯ c are the means of the logs of the (20)—Official Final Action’’ of the ‘‘Of- pericardial fluid volumes of the test and ficial Methods of Analysis of the Asso- control groups, respectively;

ciation of Official Analytical Chem- nt and nc are the number of chicks in the re- ists,’’ 13th Ed., 1980, p. 451, which is in- spective groups; 2 2 corporated by reference. Copies are st and sc are the variances of the test and available from the AOAC INTER- control groups, respectively. NATIONAL, 481 North Frederick Ave., The variances are calculated as follows: suite 500, Gaithersburg, MD 20877, or nx()(∑−∑22 x) available for inspection at the National s2 = Archives and Records Administration nn( −1) (NARA). For information on the availability of this material at NARA, call where: 202–741–6030, or go to: http:// Sx is the sum of the logs of the pericardial www.archives.gov/federallregister/ fluid volumes; codeloflfederallregulations/ Sx2 is the sum of the squares of the logs of the pericardial fluid volumes for either ibrllocations.html. the test t or control c group data. (ii) The chick-edema factor bioassay method described under ‘‘26. Oils, Fats, The test sample is judged to contain and Waxes’’ in the Journal of the Asso- chick-edema factor if the calculated ciation of Official Agricultural Chemists, ‘‘t’’ exceeds +1.3 and the mean log of Vol. 44, Page 146 (1961), or the method the pericardial fluid volume obtained described under ‘‘Chick-Edema Fac- from the negative control group multi- tor—Bioassay Method (34)—Official plied by 100 is less than 1.1461. Final Action’’ in §§ 28.113–28.117, ‘‘Offi- (iii) ‘‘Other factors toxic to chicks’’ cial Methods of Analysis of the Asso- referred to in paragraph (b)(3) of this ciation of Official Analytical Chem- section shall be determined during the ists,’’ 12th Ed., 1975, pp. 509–511, which course of the bioassay test described in is incorporated by reference, shall be paragraph (b)(4)(ii) of this section, on employed. (Copies of the methods are the basis of chick deaths or other ab- available from the AOAC INTER- normalities not attributable to chick- NATIONAL, 481 North Frederick Ave., edema factor or to the experimental suite 500, Gaithersburg, MD 20877, or conditions of the test. available for inspectionat the National (c) It is used or intended for use as a Archives and Records Administration supplementary source of fat for animal (NARA). For information on the avail- feed. ability of this material at NARA, call (d) To assure safe use of the additive, 202–741–6030, or go to: http:// in addition to the other information re- www.archives.gov/federallregister/ quired by the act: codeloflfederallregulations/ (1) The label and labeling of the addi- ibrllocations.html. ) The presence of tive, and any feed additive supplement, chick-edema factor shall be determined feed additive concentrate, feed additive premix, or complete feed prepared by a comparison between the mean log therefrom shall bear: of the pericardial fluid volumes of a (i) The name of the additive. test group and of a concurrent negative control group. The significance of the (ii) The designation ‘‘feed grade’’ in juxtaposition with the name and equal- difference in pericardial fluid volumes ly as prominent. between the test group and the nega- (2) The label or labeling of the additive control group is determined by tive and any feed additive supplement, calculating a ‘‘t’’ value according to feed additive concentrate, feed additive the formula: premix, or complete feed prepared

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therefrom shall bear adequate direc- broiler chicken feeds in accordance tions for use. with the following specifications: (a) The additive is a stereoisomer of [41 FR 38652, Sept. 10, 1976, as amended at 47 FR 9397, Mar. 5, 1982; 54 FR 18281, Apr. 28, 22-[(3-amino-3,6,dideoxy-b-D- 1989; 70 FR 40880, July 15, 2005; 70 FR 67651, mannopyranosyl)oxy]-1,3,26- Nov. 8, 2005] trihydroxy-12-methyl-10-oxo-6,11,28- trioxatricyclo[22.3.1.05, 7] octacosa- § 573.660 Methyl glucoside-coconut oil 8,14,16,18,20-pentaene-25-carboxylic acid ester. with the empirical formula C33H47NO13. Methyl glucoside-coconut oil ester (b) The additive shall conform to may be safely used in accordance with U.S.P. specifications. the following conditions: (c) The additive (as part of a premix (a) The additive meets the specifica- composed of calcium carbonate, tions prescribed in § 172.816 of this natamycin, and lactose) is used for re- chapter. tarding the growth of Aspergillus (b) It is used as a surfactant in mo- parasiticus in broiler chicken feeds for lasses intended for use in animal feed up to 14 days after the addition of at a level not to exceed 320 parts per natamycin. million. (d) Each pound (454 grams (g)) of the premix shall contain 434 (g) of calcium § 573.680 Mineral oil. carbonate, 10 g of natamycin activity, Mineral oil may be safely used in ani- and 10 g of lactose. The premix shall be mal feed, subject to the provisions of mixed into broiler chicken feed at the this section. rate of 1 pound (0.454 kilograms (kg)) (a) Mineral oil, for the purpose of this per ton (908 kg) of feed to provide section, is that complying with the def- natamycin at a level of 11 parts per inition and specifications contained in million (ppm). The premix shall be § 172.878 (a) and (b) or in § 178.3620(b)(1) thoroughly mixed into the dry compo- (i) and (ii) of this chapter. nents of the broiler chicken feed before (b) It is used in animal feeds for the adding the liquid components. Broiler following purposes: feeds to which the natamycin premix is (1) To reduce dustiness of feeds or added shall be used within 4 weeks of mineral supplements. addition of the premix. (e) To assure the safe use of the addi- (2) To serve as a lubricant in the tive, the label or labeling of the addi- preparation of pellets, cubes, or blocks tive shall bear, in addition to other in- and to improve resistance to moisture formation required by the Federal of such pellets, cubes, or blocks. Food, Drug, and Cosmetic Act, the fol- (3) To prevent the segregation of lowing: trace minerals in mineralized salt. (1) The name and CAS number of the (4) To serve as a diluent carrier in additive, and its purpose. the manufacture of feed grade biuret in (2) A listing of ingredients consisting accordance with good manufacturing of calcium carbonate, the additive, and practice. lactose and their proportions in the (5) For the removal of water from premix as prescribed under paragraph substances intended as ingredients of (d) of this section. animal feed. (3) Adequate directions for use to en- (c) The quantity of mineral oil used sure a broiler chicken feed that is in in animal feed shall not exceed 3.0 per- compliance with the limitations pre- cent in mineral supplements, nor shall scribed in paragraph (d) of this section. it exceed 0.06 percent of the total ra- (4) An appropriate cautionary state- tion when present in feed or feed con- ment: ‘‘Caution: Store in a tightly- centrates. closed, light-resistant container in a [41 FR 38652, Sept. 10, 1976, as amended at 47 cool, dry place.’’ FR 41106, Sept. 17, 1982] (5) An expiration date of 1 year from the date of manufacture. § 573.685 Natamycin. (6) A contact address and telephone The food additive natamycin (CAS number for reporting adverse reactions No. 7681–93–8) may be safely used in experienced by users, or to request a

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copy of the Material Safety Data Sheet (3) Information about emergency aid for natamycin. in case of accidental exposure as follows: [69 FR 19321, Apr. 13, 2004] (i) Statements reflecting require- § 573.696 Feed grade sodium formate. ments of applicable sections of the The food additive, feed grade sodium Superfund Amendments and Reauthor- formate, may be safely used in the ization Act (SARA), and the Occupa- manufacture of complete swine and tional Safety and Health Administra- poultry feeds in accordance with the tion (OSHA) human safety guidance following prescribed conditions: regulations. (a) The additive is manufactured by (ii) Contact address and telephone the reaction of 99 percent formic acid number for reporting adverse reactions and 50 percent sodium hydroxide in or to request a copy of the Material water to produce a solution made up of Safety Data Sheet (MSDS). at least 20.5 percent sodium salt of for- [81 FR 67154, Sept. 30, 2016, as amended at 81 mic acid and not more than 61 percent FR 95027, Dec. 27, 2016] formic acid. (b) The additive is used or intended § 573.700 Sodium nitrite. for use as a feed acidifying agent, to Sodium nitrite may be safely used in lower the pH, in complete swine and canned pet food containing meat and poultry feeds at levels not to exceed 1.2 fish in accordance with the following percent of the complete feed. (c) To assure safe use of the additive, prescribed conditions: formic acid and formate salts from all (a) It is used or intended for use added sources cannot exceed 1.2 percent alone as a preservative and color fixa- of complete feed when multiple sources tive in canned pet food containing fish, of formic acid and its salts are used in meat, and fish and meat byproducts so combination. that the level of sodium nitrite does (d) To assure safe use of the additive, not exceed 20 parts per million. in addition to the other information re- (b) To assure safe use of the additive, quired by the Federal Food, Drug, and in addition to the other information re- Cosmetic Act, the label and labeling quired by the act: shall contain: (1) The label of the additive shall (1) The name of the additive. bear: (2) Adequate directions for use, in- (i) The name of the additive. cluding a statement that feed grade so- (ii) A statement of the concentration dium formate must be uniformly ap- of the additive in any mixture. plied and thoroughly mixed into com- (2) The label or labeling shall bear plete feeds and that the complete feeds adequate directions to provide a final so treated shall be labeled as con- product that complies with the limita- taining feed grade sodium formate. tions prescribed in paragraph (a) of this (3) Cautions for use including this section. statement: Caution: Follow label directions. Formic acid and formate salts § 573.720 Petrolatum. from all added sources cannot exceed Petrolatum may be safely used in or 1.2 percent of complete feed when mul- on animal feed, subject to the fol- tiple sources of formic acid and its lowing prescribed conditions: salts are used in combination. (a) Petrolatum complies with the (e) To assure safe use of the additive, specifications set forth in the U.S. in addition to the other information re- Pharmacopeia XVI for white petro- quired by the act and paragraph (d) of latum or in The National Formulary this section, the label and labeling XII for yellow petrolatum. shall contain: (1) Appropriate warnings and safety (b) Petrolatum meets the following precautions concerning feed grade so- ultraviolet absorbance limits when dium formate. subjected to the analytical procedure (2) Statements identifying feed grade described in § 172.886(b) of this chapter. sodium formate as a corrosive and pos- Ultraviolet absorbance per centimeter sible severe irritant. path length:

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Millimicrons Maximum (3) Crude fiber, not more than 2 percent. 280 to 289 ...... 0.25 (4) Ash, not more than 13 percent. 290 to 299 ...... 20 300 to 359 ...... 14 (5) Moisture, not more than 6 per- 360 to 400 ...... 04 cent. (c) Use. To ensure safe use, the label- (c) It is used in animal feed for the ing of the additive and any feed addi- following purposes: tive supplement, concentrate, or pre- (1) To reduce dustiness of feeds or mix prepared therefrom shall bear, in mineral supplements. addition to other required information, (2) To serve as a lubricant in the the name of the additive, directions for preparation of pellets, cubes, or blocks, use to provide not more than 10 percent and to improve resistance to moisture by weight of the total ration, and the of such pellets, cubes, or blocks. statement ‘‘Caution: Not to be used in (d) The quantity of petrolatum layers or other poultry intended for present in animal feeds from the uses breeding.’’ specified in paragraph (c) of this sec- [58 FR 59170, Nov. 8, 1993] tion shall not exceed 3 percent in mineral supplements nor shall it exceed § 573.760 Poloxalene. 0.06 percent of the total ration when The food additive poloxalene may be present in feed or feed concentrates. safely used in accordance with the fol- (e) When used in combination with lowing prescribed conditions: technical white mineral oil for the uses (a) The additive consists of polyoxy- described in paragraph (c) of this sec- propylene-polyoxyethylene glycol non- tion, the total quantity of combined ionic block polymer meeting the fol- petrolatum and technical white min- lowing specifications: eral oil shall not exceed the limits pre- (1) Molecular weight range: 2,850– scribed in paragraph (d) of this section. 3,150. (f) Petrolatum may contain any anti- (2) Hydroxyl number: 35.7–39.4. oxidant permitted in food by regula- (3) Cloud point (10 percent solution): tions issued in accordance with section 42 °C–46 °C. 409 of the act, in an amount not greater (4) Structural formula: than that required to produce its in- ⎯⎯ tended effect. HO(CH2211 CH O)( -13) ⎯⎯ ⎯⎯ CHCH2 O(32-36) ( CH2211 CH O)( -13) H § 573.740 Odorless light petroleum hy- drocarbons. CH3 Odorless light petroleum hydro- (b) In feed as a surfactant for the carbons complying with § 172.884(a) and flaking of feed grains when added to (b) of this chapter may be safely used liquid grain conditioner in an amount in an amount not in excess of that re- not to exceed 1.0 percent of the condi- quired as a component of insecticide tioner. The conditioner is added to the formulations used in compliance with feed at a rate of 1 quart per ton of feed. regulations issued in this part. (c) The label and labeling shall bear, in addition to the other information re- § 573.750 Pichia pastoris dried yeast. quired by the Act: (a) Identity. The food additive Pichia (1) The name of the additive. pastoris dried yeast may be used in feed (2) Adequate directions and warnings formulations of broiler chickens as a for use. source of protein not to exceed 10 percent by weight of the total formula- § 573.780 Polyethylene. tion. (a) Identity. Polyethylene consists of (b) Specifications. The additive shall basic polymers manufactured by the conform to the following percent-by- catalytic polymerization of ethylene. weight specifications: (b) Specifications. (1) For the purposes (1) Crude protein, not less than 60 of this section, polyethylene shall meet percent. the specifications in item 2.1 of (2) Crude fat, not less than 2 percent. § 177.1520(c) of this chapter.

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(2) The polyethylene is designed in a (b) It is used as an emulsifier in milk- pellet form in a configuration pre- replacer formulations for calves. senting maximum angular surface having the following dimensions in centi- § 573.860 Polysorbate 80. meters: The food additive polysorbate 80 0.9 ±0.1 × 0.8 ±0.1 × 1.2 ±0.1 (polyoxyethylene (20) sorbitan monooleate) may be safely used as an (c) Use. It is used as a replacement emulsifier in milk-replacer formula- for roughage in feedlot rations for fin- tions for calves. ishing slaughter cattle. (d) Labeling. The labels and labeling § 573.870 Poly(2-vinylpyridine-co-sty- shall bear in addition to the other in- rene). formation required by the Act: (1) The name of the additive ‘‘poly- The food additive poly(2- ethylene roughage replacement.’’ vinylpyridine-co-styrene) may be safe- (2) Adequate directions for use which ly used as nutrient protectant in feed shall provide for the administration of for beef cattle and dairy cattle and re- one-half pound of polyethylene pellets placement dairy heifers when used in per head per day for 6 successive days. accordance with the following condi- All natural roughage should be re- tions: moved for a minimum of 12 hours prior (a) The additive meets the following to administration of polyethylene specifications: roughage replacement. Roughage re- Component/property Limitation placement must be adequately mixed in the ration for uniform distribution. Inherent viscosity ...... 1.0-1.6 deciliter per gram.1 Styrene moiety ...... 40 percent maximum. [41 FR 38652, Sept. 10, 1976, as amended at 54 2-Vinylpyridine moiety...... 90 percent maximum. FR 18282, Apr. 28, 1989] Residual styrene ...... 200 parts per billion maximum. § 573.800 Polyethylene glycol (400) Residual 2-vinylstyrene ...... 200 parts per billion maximum. mono- and dioleate. Heavy metals such as lead .... 10 parts per million max- (a) The food additive polyethylene imum. glycol (400) mono- and dioleate meets Arsenic ...... 3 parts per million maximum. the following specifications: Saponi- 1 Inherent viscosity of a 0.25 percent (weight/volume) solu- fication number, 80–88; acid number, 5.0 tion in dimethylformamide. maximum; and average molecular (b) The additive is used in the manu- weight range, 640–680. facture of rumen-stable, abomasum- (b) It is used as a processing aid in dispersible nutrient(s) for beef cattle the production of animal feeds when and dairy cattle and replacement dairy present as a result of its addition to heifers such that the maximum use of molasses in an amount not to exceed the additive from all sources does not 250 parts per million of the molasses. exceed 5.1 grams per head per day. The additive may be used to protect the fol- § 573.820 Polyoxyethylene glycol (400) lowing nutrients: mono- and dioleates. (1) Methionine. The resulting product The food additive polyoxyethylene must contain a maximum of 10 percent glycol (400) mono- and dioleates may be poly(2-vinylpyridine-co-styrene) by safely used as an emulsifier in calf- weight and a minimum of 55 percent milk replacer formulations. methionine by weight. The coated methionine must be established through § 573.840 Polysorbate 60. in vitro tests to be at least 90 percent The food additive polysorbate 60 rumen-stable, of which at least 90 per- (polyoxyethylene (20) sorbitan mono- cent is subsequently dispersible under stearate) may be safely used in animal abomasal conditions. feeds in accordance with the following (2) Methionine and lysine. The result- prescribed conditions: ing product must contain a maximum (a) It is used alone or in combination of 10 percent poly(2-vinylpyridine-co- with sorbitan monostearate as an styrene) by weight and a minimum of a emulsifier in mineral premixes and die- combined total of 55 percent methio- tary supplements for animal feeds. nine and lysine by weight. The coated

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methionine and lysine must be estab- volatile fatty acids and shall conform lished through in vitro tests to be at to the following specifications: least 90 percent rumen-stable, of which (1) Ammonium salts: at least 90 percent is subsequently dispersible under abomasal conditions. Components Amount (c) Label and labeling. To ensure safe Ammonium salts of mixed 5-car- 48 to 54 percent. use of the additive, the label and label- bon acids (as identified in para- ing of the additive and of any feed addi- graph (a) of this section). Ammonium salt of isobutyric acid 22 to 26 percent. tive supplement, feed additive con- Water ...... 28 percent maximum. centrate, feed additive premix, or liq- Ammonia ...... 0.3 percent maximum. uid feed supplement prepared there- Arsenic ...... 3 parts per million max- from, shall bear, in addition to the imum. Heavy metals such as lead ...... 10 parts per million max- other information required by the Fed- imum. eral Food, Drug, and Cosmetic Act, the following: (2) Calcium salts: (1) The name of the additive. (2) A statement of the concentration Components Amount of poly(2-vinylpyridine-co-styrene) in Calcium salts of mixed 5-carbon 58 to 72 percent. any product or mixture. acids (as identified in paragraph (3) Adequate directions for the use of (a) of this section). Calcium salt of isobutyric acid ...... 26 to 34 percent. the rumen-stable, abomasum-dispers- Calcium hydroxide ...... 3 percent maximum. ible nutrient(s) products. Water ...... 14 percent maximum. (4) The following statement: ‘‘Warn- Arsenic ...... 3 parts per million max- ing: Maximum use of poly(2- imum. Heavy metals such as lead ...... 10 parts per million max- vinylpyridine-co-styrene) from all imum. sources is not to exceed 5.1 grams per head per day.’’ (c) Use. The additive is used or in- [57 FR 7875, Mar. 5, 1992, as amended at 57 FR tended for use as a source of energy in 24187, June 8, 1992; 61 FR 11547, Mar. 21, 1996; dairy cattle feed. 70 FR 13100, Mar. 18, 2005] (d) Labeling. The label and labeling of the additive in any feed, feed supple- § 573.880 Normal propyl alcohol. ment, feed concentrate, feed premix, or Normal propyl alcohol may be safely liquid feed supplement prepared there- used in feeds and feed supplements for from shall bear, in addition to other in- cattle as a source of metabolizable en- formation required by the act, the fol- ergy. It is incorporated in the feed or lowing: feed supplement in an amount which (1) The name of the additive. provides not more than 54.5 grams of (2) Adequate directions for use, in- the additive per head per day. cluding statements expressing maximum use levels. For ammonium salts § 573.900 Pyrophyllite. of volatile fatty acids, the statements: Pyrophyllite (aluminum silicate ‘‘Not to exceed 160 grams per head per monohydrate) may be safely used as day thoroughly mixed in dairy cattle the sole anticaking aid, blending agent, feed as a source of energy.’’ For cal- pelleting aid, or carrier in animal feed cium salts of volatile fatty acids, the when incorporated therein in an statement: ‘‘Not to exceed 135 grams amount not to exceed 2 percent in com- per head per day thoroughly mixed in plete animal feed. dairy cattle feed as a source of energy.’’ § 573.914 Salts of volatile fatty acids. [49 FR 45125, Nov. 15, 1984; 50 FR 8606, Mar. 4, (a) Identity. The food additive is a 1985, as amended at 70 FR 13100, Mar. 18, 2005] blend containing the ammonium or calcium salt of isobutyric acid and the § 573.920 Selenium. ammonium or calcium salts of a mix- (a) Public Law 103–354 enacted Octo- ture of 5-carbon acids—isovaleric, 2- ber 13, 1994 (the 1994 Act), states that methylbutyric, and n-valeric. FDA shall not implement or enforce (b) Specifications. The additive con- the final rule issued on September 13, tains ammonium or calcium salts of 1993 (58 FR 47962), in which FDA stayed

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the 1987 amendments and any modifica- (d) The additive shall be incorporated tion of such rule issued after enact- into feed as follows: ment of the 1994 Act; unless the Com- (1) It shall be incorporated into each missioner of Food and Drugs makes a ton of complete feed by adding no less determination that: than 1 pound of a premix containing no (1) Selenium additives are not essen- more than 272.4 milligrams of added se- tial at levels authorized in the absence lenium per pound. of such final rule, to maintain animal (2) It shall be incorporated into each nutrition and protect animal health; ton of salt-mineral mixture for sheep (2) selenium at such levels is not safe or beef cattle from a premix containing to the animals consuming the additive; no more than 4.5 grams of added sele- (3) selenium at such levels is not safe nium per pound. to individuals consuming edible por- (e) The premix manufacturer shall tions of animals that receive the addi- follow good manufacturing practices in tive; the production of selenium premixes. (4) selenium at such levels does not Inventory, production, and distribution achieve its intended effect of pro- records must provide a complete and moting normal growth and reproduc- accurate history of product production. tion of livestock and poultry; and Production controls must assure prod- (5) the manufacture and use of sele- ucts to be what they are purported and nium at such levels cannot reasonably labeled. Production controls shall in- be controlled by adherence to current clude analysis sufficient to adequately good manufacturing practice require- monitor quality. ments. (f) The label or labeling of any sele- (6) Paragraphs (b) through (g) of this nium premix shall bear adequate direc- section provide the currently accept- tions and cautions for use including able levels of selenium supplemen- this statement: ‘‘Caution: Follow label tation. directions. The addition to feed of (b) The food additive selenium is a higher levels of this premix containing nutrient administered in animal feed selenium is not permitted.’’ as sodium selenite or sodium selenate (g) The additive is orally adminis- or in a controlled-release sodium sele- tered to beef and dairy cattle as an os- nite bolus, as provided in paragraphs (f) motically controlled, constant release and (g) of this section, or as selenium bolus containing sodium selenite. Each yeast, as provided in paragraph (h) of bolus contains 360 milligrams of sele- this section. nium as sodium selenite, and delivers 3 (c) It is added to feed as follows: milligrams of selenium per day for 120 (1) In complete feed for chickens, days. To ensure safe use of the addi- swine, turkeys, sheep, cattle, and tive: ducks at a level not to exceed 0.3 part (1) The osmotically controlled, con- per million. stant release bolus is for use only in (2) In feed supplements for limit feed- beef and dairy cattle more than 3 ing as follows: months of age or over 200 pounds body (i) Sheep: At a level not to exceed an weight. intake of 0.7 milligram per head per (2) Only one bolus containing 360 mil- day. ligrams of selenium as sodium selenite (ii) Beef cattle: At a level not to ex- is administered orally to each animal ceed an intake of 3 milligrams per head in 120 days. per day. (3) The labeling shall bear the fol- (3) In salt-mineral mixtures for free- lowing: ‘‘This bolus delivers the max- choice feeding as follows: imum daily allowable amount of sele- (i) Sheep: Up to 90 parts per million in nium and shall be the sole source of a mixture for free-choice feeding at a supplementation. Do not use in areas rate not to exceed an intake of 0.7 mil- containing excess selenium. Do not ligram per head per day. rebolus within 4 months.’’ (ii) Beef cattle: Up to 120 parts per (h) Selenium yeast is a dried, non- million in a mixture for free-choice viable yeast (Saccharomyces cerevisiae) feeding at a rate not to exceed an in- cultivated in a fed-batch fermentation take of 3 milligrams per head per day. which provides incremental amounts of

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cane molasses and selenium salts in a § 573.940 Silicon dioxide. manner which minimizes the detri- The food additive silicon dioxide may mental effects of selenium salts on the be safely used in animal feed in accord- growth rate of the yeast and allows for ance with the following conditions: optimal incorporation of inorganic selenium into cellular organic material. (a) The food additive is manufactured Residual inorganic selenium is elimi- by vapor phase hydrolysis or by other nated in a rigorous washing process means whereby the particle size is such and must not exceed 2 percent of the as to accomplish the intended effect. total selenium content in the final se- (b) It is used or intended for use in lenium yeast product. feed components as an anticaking (1) Selenium, as selenium yeast, is agent, and/or grinding aid, as follows: added to feed as follows: Limitations (i) In complete feed for chickens, tur- Feed component (percent) keys, swine, beef cattle, and dairy cattle at a level not to exceed 0.3 part per BHT (butylated hydroxytoluene) ...... 2 Methionine hydroxy analog and its calcium salts 1 million. Piperazine, piperazine salts ...... 0.8 (ii) In feed supplements for limit Sodium propionate ...... 1 feeding for beef cattle at a level not to Urea ...... 1 exceed an intake of 3 milligrams per Vitamins ...... 3 head per day. (iii) In salt-mineral mixtures for free- (c) It is used in feed as an anticaking choice feeding for beef cattle up to 120 agent in an amount not to exceed that parts per million in a mixture for free- reasonably required to accomplish its choice feeding at a rate not to exceed intended effect and in no case in an an intake of 3 milligrams per head per amount to exceed 2 percent by weight day. of the finished feed. (2) Guaranteed organic selenium con- (d) It is used or intended for use in tent from selenium yeast must be de- feed components, as a carrier as fol- clared on the selenium yeast product lows: label. Limitations (3) The additive, as selenium yeast, Feed component (percent) shall be incorporated into feed as follows: Flavors ...... 50 (i) It shall be incorporated into each ton of complete feed by adding no less (e) To ensure safe use of the additive, than 1 pound of a premix containing no silicon dioxide is to be used in an more than 272.4 milligrams of added se- amount not to exceed that reasonably lenium per pound. required to accomplish its intended ef- (ii) It shall be incorporated into each fect, and silicon dioxide from all ton of salt-mineral mixture for beef sources cannot exceed 2 percent by cattle from a premix containing no weight of the complete feed. more than 4.5 grams of added selenium [41 FR 38652, Sept. 10, 1976, as amended at 83 per pound. FR 8930, Mar. 2, 2018] (4) Usage of this additive must conform to the requirements of paragraphs § 573.960 Sorbitan monostearate. (e) and (f) of this section. The food additive sorbitan monostea- [52 FR 10888, Apr. 6, 1987; 52 FR 21001, June 4, rate may be safely used alone or in 1987, as amended at 54 FR 14215, Apr. 10, 1989; combination with polysorbate 60 as an 54 FR 15874, Apr. 19, 1989; 60 FR 53703, Oct. 17, emulsifier in mineral premixes and die- 1995; 65 FR 35824, June 6, 2000; 65 FR 53167, tary supplements for animal feeds. Sept. 1, 2000; 67 FR 46851, July 17, 2002; 68 FR 52340, Sept. 3, 2003; 72 FR 39561, July 19, 2007] § 573.980 Taurine. EFFECTIVE DATE NOTE: At 58 FR 47973, The food additive taurine (2-amino- Sept. 13, 1993, the amendments to § 573.920 ethanesulfonic acid) may be safely used that were published at 52 FR 10887, Apr. 6, in feed in accordance with the fol- 1987; 52 FR 21001, June 4, 1987; and 54 FR 14214, Apr. 10, 1989 were stayed until further lowing prescribed conditions: notice. At 59 FR 45973, Sept. 6, 1994, the stay (a) It is used as a nutritional supple- was confirmed. ment in the feed of growing chickens.

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(b) It is added to complete feeds so tended effect and in no case to exceed that the total taurine content does not 1 percent by weight of the final feed. exceed 0.054 percent of the feed. (b) To assure safe use of the additive, (c) To assure safe use of the additive, the label of any feed additive supple- the label and labeling shall bear in ad- ment, feed additive concentrate, feed dition to the other information re- additive premix, or complete feed pre- quired by the Act: pared therefrom shall bear, in addition (1) The name of the additive. to the other information required by (2) The quantity of the additive con- the Act, the name of the additive tained therein. (verxite granules, verxite flakes, or (3) Adequate directions for use. verxite grits), adequate directions for use, and, when the additive is present § 573.1000 Verxite. in excess of 1 percent, a statement of The food additive verxite may be the quantity of the additive contained safely used in animal feed in accord- therein and the term ‘‘nonnutritive’’ in ance with the following prescribed con- juxtaposition therewith. ditions: (a) The additive is a magnesium-alu- § 573.1010 Xanthan gum. minum-iron silicate conforming to one of the following: The food additive xanthan gum may (1)(i) Verxite granules: The additive be safely used in animal feed as fol- contains a minimum of 98 percent of lows: hydrobiotite; it is thermally expanded (a) The food additive is xanthan gum and has a bulk density of from 5 to 9 as defined in § 172.695 of this chapter pounds per cubic foot. and meets all of the specifications (ii) It is used or intended for use: thereof. (a) In poultry feed at a level not to (b) It is used or intended for use as a exceed 5 percent of the weight of the stabilizer, emulsifier, thickener, sus- finished feed as a nonnutritive bulking pending agent, or bodying agent in ani- agent for restricting calorie intake in mal feed as follows: pullet replacement feeds. (1) In calf milk replacers at a max- (b) As an anticaking or blending imum use level of 0.1 percent, as fed. agent, pelleting aid, or nonnutritive (2) In liquid feed supplements for ru- carrier for the incorporation of nutri- minant animals at a maximum use ents in poultry, swine, dog, or rumi- level of 0.25 percent (5 pounds per ton). nant feeds, in an amount not to exceed (c) To assure safe use of the additive: that necessary to accomplish its in- (1) The label of its container shall tended effect and in no case to exceed bear, in addition to other information 1.5 percent of the dog feed or 5 percent required by the act, the name of the of the final feed for other animals. additive. (2)(i) Verxite flakes: The additive contains a minimum of 98 percent of (2) The label or labeling of the addi- hydrobiotite; it has a bulk density of tive container shall bear adequate di- from 20 to 30 pounds per cubic foot. rections for use. (ii) It is used or intended for use as [49 FR 44630, Nov. 8, 1984] an anticaking or blending agent in ruminant feeds in an amount not to ex- § 573.1020 Yellow prussiate of soda. ceed that necessary to accomplish its Yellow prussiate of soda (sodium fer- intended effect and in no case to exceed rocyanide decahydrate: Na Fe(Cn) °- 1 percent by weight of the final feed for 4 6 10H O) may be safely used as an ruminants. 2 anticaking agent in salt for animal (3)(i) Verxite grits: The additive con- consumption at a level not to exceed 13 tains a minimum of 80 percent of parts per million. The additive con- hydrobiotite; it has a bulk density of tains a minimum of 99.0 percent by from 40 to 50 pounds per cubic foot. weight of sodium ferrocyanide decahy- (ii) It is used or intended for use as a partial roughage replacement in rumi- drate. nant feeds in an amount not to exceed [41 FR 38657, Sept. 10, 1976; 41 FR 48100, Nov. that necessary to accomplish its in- 2, 1976]

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PART 579—IRRADIATION IN THE (b) Uses. (1) The ionizing radiation is PRODUCTION, PROCESSING, used or intended for use in single treat- AND HANDLING OF ANIMAL ment as follows: FEED AND PET FOOD Food for irradiation Limitations Use

Bagged complete Absorbed dose: Microbial disinfec- Subpart A—General Provisions diets, packaged Not to exceed tion, control or feeds, feed ingre- 50 kiloGrays. elimination Sec. dients, bulk feeds, Feeds and 579.12 Incorporation of regulations in part animal treats and feed ingredi- 179. chews. ents treated by irradiation should be for- Subpart B—Radiation and Radiation mulated to Sources account for nutritional 579.22 Ionizing radiation for treatment of loss. animal diets. 579.40 Ionizing radiation for the treatment (2) If an irradiated feed ingredient is of poultry feed and poultry feed ingredi- less than 5 percent of the final product, ents. the final product can be irradiated AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 371. without being considered to be re-irradiated. Subpart A—General Provisions [51 FR 5993, Feb. 19, 1986; 51 FR 8315, Mar. 11, 1986, as amended at 58 FR 18148, Apr. 8, 1993; § 579.12 Incorporation of regulations 66 FR 18540, Apr. 10, 2001] in part 179. § 579.40 Ionizing radiation for the Regulations providing for irradiation treatment of poultry feed and poul- in the production, processing, and han- try feed ingredients. dling of food in part 179 of this chapter Ionizing radiation for the treatment are incorporated in subchapter E as ap- of complete poultry diets and poultry plicable to use in the production, proc- feed ingredients may be safely used as essing, handling, and labeling of ani- follows: mal feed and pet food, except where (a) Energy sources. Ionizing radiation specifically provided for in this part. is limited to: Any facility that treats animal feed (1) Gamma rays from sealed units of and pet food with ionizing radiation cobalt-60 or cesium-137; must comply with the requirements of (2) Electrons generated from machine part 507 of this chapter and other appli- sources at energy levels not to exceed cable regulations. 10 million electron volts (MeV); [51 FR 5993, Feb. 19, 1986, as amended at 80 (3) X-rays generated from machine FR 56356, Sept. 17, 2015] sources at energies not to exceed 5 MeV, except as permitted by Subpart B—Radiation and § 179.26(a)(4) of this chapter; or (4) X-rays generated from machine Radiation Sources sources using tantalum or gold as the target material and using energies not § 579.22 Ionizing radiation for treatment of animal diets. to exceed 7.5 MeV. (b) Limitation. The ionizing radiation Ionizing radiation for treatment of is used for feed or feed ingredients that complete diets for animals may be do not contain drugs. safely used under the following condi- (c) Use. Ionizing radiation is used as tions: a single treatment for rendering com- (a) Energy sources. Ionizing radiation plete poultry diets or poultry feed in- is limited to: gredients salmonella negative as fol- (1) Gamma rays for sealed units of lows: the radionuclides cobalt-60 or cesium- (1) Minimum dose 2.0 kiloGrays (kGy) 137. (0.2 megarad (Mrad)); maximum dose 25 (2) Electrons generated from machine kGy (2.5 megarads Mrad). The absorbed sources at energy levels not to exceed dose of irradiation is to be based on ini- 10 million electron volts. tial concentration of salmonella using

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the relationship that 1.0 kGy (0.1 Mrad) 582.1141 Ammonium phosphate. reduces salmonella concentration by 582.1143 Ammonium sulfate. one log cycle (one decimal reduction). 582.1155 Bentonite. 582.1165 Butane. (2) Feeds treated by irradiation 582.1191 Calcium carbonate. should be formulated to account for 582.1193 Calcium chloride. nutritional loss. 582.1195 Calcium citrate. (3) If an irradiated feed ingredient is 582.1199 Calcium gluconate. less than 5 percent of the final product, 582.1205 Calcium hydroxide. the final product can be irradiated 582.1207 Calcium lactate. without being considered to be re- 582.1210 Calcium oxide. 582.1217 Calcium phosphate. irradiated. 582.1235 Caramel. [60 FR 50099, Sept. 28, 1995, as amended at 78 582.1240 Carbon dioxide. FR 27304, May 10, 2013; 78 FR 34565, June 10, 582.1275 Dextrans. 2013] 582.1320 Glycerin. 582.1324 Glyceryl monostearate. 582.1355 Helium. PART 582—SUBSTANCES 582.1366 Hydrogen peroxide. GENERALLY RECOGNIZED AS SAFE 582.1400 Lecithin. 582.1425 Magnesium carbonate. Subpart A—General Provisions 582.1428 Magnesium hydroxide. 582.1431 Magnesium oxide. Sec. 582.1480 Methylcellulose. 582.1 Substances that are generally recog- 582.1500 Monoammonium glutamate. nized as safe. 582.1516 Monopotassium glutamate. 582.10 Spices and other natural seasonings 582.1540 Nitrogen. and flavorings. 582.1585 Papain. 582.20 Essential oils, oleoresins (solvent- 582.1613 Potassium bicarbonate. free), and natural extractives (including 582.1619 Potassium carbonate. distillates). 582.1625 Potassium citrate. 582.30 Natural substances used in conjunc- 582.1631 Potassium hydroxide. tion with spices and other natural 582.1643 Potassium sulfate. seasonings and flavorings. 582.1655 Propane. 582.40 Natural extractives (solvent-free) 582.1666 Propylene glycol. used in conjunction with spices, 582.1685 Rennet. seasonings, and flavorings. 582.1711 Silica aerogel. 582.50 Certain other spices, seasonings, es- 582.1721 Sodium acetate. sential oils, oleoresins, and natural ex- 582.1736 Sodium bicarbonate. tracts. 582.1742 Sodium carbonate. 582.60 Synthetic flavoring substances and 582.1745 Sodium carboxymethylcellulose. 582.1748 Sodium caseinate. adjuvants. 582.1751 Sodium citrate. 582.80 Trace minerals added to animal feeds. 582.1763 Sodium hydroxide. 582.99 Adjuvants for pesticide chemicals. 582.1775 Sodium pectinate. Subpart B—General Purpose Food 582.1778 Sodium phosphate. 582.1781 Sodium aluminum phosphate. Additives 582.1792 Sodium sesquicarbonate. 582.1005 Acetic acid. 582.1804 Sodium potassium tartrate. 582.1009 Adipic acid. 582.1810 Sodium tripolyphosphate. 582.1033 Citric acid. 582.1901 Triacetin. 582.1057 Hydrochloric acid. 582.1973 Beeswax. 582.1061 Lactic acid. 582.1975 Bleached beeswax. 582.1069 Malic acid. 582.1978 Carnauba wax. 582.1073 Phosphoric acid. 582.1077 Potassium acid tartrate. Subpart C—Anticaking Agents 582.1087 Sodium acid pyrophosphate. 582.2122 Aluminum calcium silicate. 582.1091 Succinic acid. 582.2227 Calcium silicate. 582.1095 Sulfuric acid. 582.2437 Magnesium silicate. 582.1099 Tartaric acid. 582.2727 Sodium aluminosilicate. 582.1125 Aluminum sulfate. 582.2729 Hydrated sodium calcium 582.1127 Aluminum ammonium sulfate. aluminosilicate. 582.1129 Aluminum potassium sulfate. 582.2906 Tricalcium silicate. 582.1131 Aluminum sodium sulfate. 582.1135 Ammonium bicarbonate. Subpart D—Chemical Preservatives 582.1137 Ammonium carbonate. 582.1139 Ammonium hydroxide. 582.3013 Ascorbic acid.

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582.3021 Benzoic acid. 582.5304 Ferric pyrophosphate. 582.3041 Erythorbic acid. 582.5306 Ferric sodium pyrophosphate. 582.3081 Propionic acid. 582.5308 Ferrous gluconate. 582.3089 Sorbic acid. 582.5311 Ferrous lactate. 582.3109 Thiodipropionic acid. 582.5315 Ferrous sulfate. 582.3149 Ascorbyl palmitate. 582.5361 Histidine. 582.3169 Butylated hydroxyanisole. 582.5370 Inositol. 582.3173 Butylated hydroxytoluene. 582.5375 Iron reduced. 582.3189 Calcium ascorbate. 582.5381 Isoleucine. 582.3221 Calcium propionate. 582.5406 Leucine. 582.3225 Calcium sorbate. 582.5411 Lysine. 582.3280 Dilauryl thiodipropionate. 582.5431 Magnesium oxide. 582.3336 Gum guaiac. 582.5434 Magnesium phosphate. 582.3490 Methylparaben. 582.5443 Magnesium sulfate. 582.3616 Potassium bisulfite. 582.5446 Manganese chloride. 582.3637 Potassium metabisulfite. 582.5449 Manganese citrate. 582.3640 Potassium sorbate. 582.5452 Manganese gluconate. 582.3660 Propyl gallate. 582.5455 Manganese glycerophosphate. 582.3670 Propylparaben. 582.5458 Manganese hypophosphite. 582.3731 Sodium ascorbate. 582.5461 Manganese sulfate. 582.3733 Sodium benzoate. 582.5464 Manganous oxide. 582.3739 Sodium bisulfite. 582.5470 Mannitol. 582.3766 Sodium metabisulfite. 582.5475 Methionine. 582.3784 Sodium propionate. 582.5477 Methionine hydroxy analog and its 582.3795 Sodium sorbate. calcium salts. 582.3798 Sodium sulfite. 582.5530 Niacin. 582.3845 Stannous chloride. 582.5535 Niacinamide. 582.3862 Sulfur dioxide. 582.5580 D-Pantothenyl alcohol. 582.3890 Tocopherols. 582.5590 Phenylalanine. 582.5622 Potassium chloride. Subpart E—Emulsifying Agents 582.5628 Potassium glycerophosphate. 582.5634 Potassium iodide. 582.4101 Diacetyl tartaric acid esters of 582.5650 Proline. mono- and diglycerides of edible fats or 582.5676 Pyridoxine hydrochloride. oils, or edible fat-forming fatty acids. 582.5695 Riboflavin. 582.4505 Mono- and diglycerides of edible 582.5697 Riboflavin-5-phosphate. fats or oils, or edible fat-forming acids. 582.5701 Serine. 582.4521 Monosodium phosphate derivatives 582.5772 Sodium pantothenate. of mono- and diglycerides of edible fats 582.5778 Sodium phosphate. or oils, or edible fat-forming fatty acids. 582.5835 Sorbitol. 582.4666 Propylene glycol. 582.5875 Thiamine hydrochloride. 582.5878 Thiamine mononitrate. Subpart F—Nutrients and/or Dietary 582.5881 Threonine. Supplements 582.5890 Tocopherols. 582.5892 a-Tocopherol acetate. 582.5013 Ascorbic acid. 582.5915 Tryptophane. 582.5017 Aspartic acid. 582.5920 Tyrosine. 582.5049 Aminoacetic acid. 582.5925 Valine. 582.5065 Linoleic acid. 582.5930 Vitamin A. 582.5118 Alanine. 582.5933 Vitamin A acetate. 582.5145 Arginine. 582.5936 Vitamin A palmitate. 582.5159 Biotin. 582.5945 Vitamin B12. 582.5191 Calcium carbonate. 582.5950 Vitamin D2. 582.5195 Calcium citrate. 582.5953 Vitamin D3. 582.5201 Calcium glycerophosphate. 582.5985 Zinc chloride. 582.5210 Calcium oxide. 582.5988 Zinc gluconate. 582.5212 Calcium pantothenate. 582.5991 Zinc oxide. 582.5217 Calcium phosphate. 582.5994 Zinc stearate. 582.5223 Calcium pyrophosphate. 582.5997 Zinc sulfate. 582.5230 Calcium sulfate. 582.5245 Carotene. Subpart G—Sequestrants 582.5250 Choline bitartrate. 582.5252 Choline chloride. 582.6033 Citric acid. 582.5260 Copper gluconate. 582.6085 Sodium acid phosphate. 582.5271 Cysteine. 582.6099 Tartaric acid. 582.5273 Cystine. 582.6185 Calcium acetate. 582.5301 Ferric phosphate. 582.6193 Calcium chloride.

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582.6195 Calcium citrate. (b) For the purposes of this section, 582.6197 Calcium diacetate. good manufacturing or feeding practice 582.6199 Calcium gluconate. shall be defined to include the fol- 582.6203 Calcium hexametaphosphate. 582.6215 Monobasic calcium phosphate. lowing restrictions: 582.6219 Calcium phytate. (1) The quantity of a substance added 582.6285 Dipotassium phosphate. to animal food does not exceed the 582.6290 Disodium phosphate. amount reasonably required to accom- 582.6386 Isopropyl citrate. plish its intended physical, nutritional, 582.6511 Monoisopropyl citrate. 582.6625 Potassium citrate. or other technical effect in food; and 582.6751 Sodium citrate. (2) The quantity of a substance that 582.6754 Sodium diacetate. becomes a component of animal food as 582.6757 Sodium gluconate. a result of its use in the manufac- 582.6760 Sodium hexametaphosphate. turing, processing, or packaging of 582.6769 Sodium metaphosphate. 582.6778 Sodium phosphate. food, and which is not intended to ac- 582.6787 Sodium pyrophosphate. complish any physical or other tech- 582.6789 Tetra sodium pyrophosphate. nical effect in the food itself, shall be 582.6801 Sodium tartrate. reduced to the extent reasonably pos- 582.6804 Sodium potassium tartrate. sible. 582.6807 Sodium thiosulfate. 582.6810 Sodium tripolyphosphate. (3) The substance is of appropriate 582.6851 Stearyl citrate. grade and is prepared and handled as a food ingredient. Upon request the Com- Subpart H—Stabilizers missioner will offer an opinion, based 582.7115 Agar-agar. on specifications and intended use, as 582.7133 Ammonium alginate. to whether or not a particular grade or 582.7187 Calcium alginate. lot of the substance is of suitable pu- 582.7255 Chondrus extract. rity for use in food and would generally 582.7330 Gum arabic. be regarded as safe for the purpose in- 582.7333 Gum ghatti. tended, by experts qualified to evaluate 582.7339 Guar gum. 582.7343 Locust bean gum. its safety. 582.7349 Sterculia gum. (c) The inclusion of substances in the 582.7351 Gum tragacanth. list of nutrients does not constitute a 582.7610 Potassium alginate. finding on the part of the Department 582.7724 Sodium alginate. that the substance is useful as a sup- AUTHORITY: 21 U.S.C. 321, 342, 348, 371. plement to the diet for animals. SOURCE: 41 FR 38657, Sept. 10, 1976, unless (d) Substances that are generally rec- otherwise noted. ognized as safe for their intended use within the meaning of section 409 of Subpart A—General Provisions the Act are listed in subparts B through H of this part. When the status § 582.1 Substances that are generally of a substance has been reevaluated recognized as safe. and affirmed as GRAS or deleted from (a) It is impracticable to list all sub- subparts B through H of this part, an stances that are generally recognized appropriate explanation will be noted, as safe for their intended use. However, e.g., ‘‘affirmed as GRAS,’’ ‘‘food addi- by way of illustration, the Commis- tive regulation,’’ ‘‘interim food addi- sioner regards such common food in- tive regulation,’’ or ‘‘prohibited from gredients as salt, pepper, sugar, vin- use in food,’’ with a reference to the egar, baking powder, and monosodium appropriate new regulation. Such nota- glutamate as safe for their intended tion will apply only to the specific use use. The lists in subparts B through H covered by the review, e.g., direct ani- of this part include additional sub- mal food use and/or indirect animal stances that, when used for the pur- food use and/or animal feed use and poses indicated, in accordance with will not affect its status for other uses good manufacturing or feeding practice, are regarded by the Commissioner not specified in the referenced regula- as generally recognized as safe for such tion, pending a specific review of such uses. other uses.

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§ 582.10 Spices and other natural ognized as safe for their intended use, seasonings and flavorings. within the meaning of section 409 of Spices and other natural seasonings the act, are as follows: and flavorings that are generally rec-

Common name Botanical name of plant source

Alfalfa herb and seed ...... Medicago sativa L. Allspice ...... Pimenta officinalis Lindl. Ambrette seed ...... Hibiscus abelmoschus L. Angelica ...... Angelica archangelica L. or other spp. of Angelica. Angelica root ...... Do. Angelica seed ...... Do. Angostura (cusparia bark) ...... Galipea officinalis Hancock. Anise ...... Pimpinella anisum L. Anise, star ...... Illicium verum Hook. f. Balm (lemon balm) ...... Melissa officinalis L. Basil, bush ...... Ocimum minimum L. Basil, sweet ...... Ocimum basilicum L. Bay ...... Laurus nobilis L. Calendula ...... Calendula officinalis L. Camomile (chamomile), English or Roman ...... Anthemis nobilis L. Camomile (chamomile), German or Hungarian ...... Matricaria chamomilla L. Capers ...... Capparis spinosa L. Capsicum ...... Capsicum frutescens L. or Capsicum annuum L. Caraway ...... Carum carvi L. Caraway, black (black cumin) ...... Nigella sativa L. Cardamom (cardamon) ...... Elettaria cardamomum Maton. Cassia, Chinese ...... Cinnamomum cassia Blume. Cassia, Padang or Batavia ...... Cinnamomum burmanni Blume. Cassia, Saigon ...... Cinnamomum loureirii Nees. Cayenne pepper ...... Capsicum frutescens L. or Capsicum annuum L. Celery seed ...... Apium graveolens L. Chervil ...... Anthriscus cerefolium (L.) Hoffm. Chives ...... Allium schoenoprasum L. Cinnamon, Ceylon ...... Cinnamomum zeylanicum Nees. Cinnamon, Chinese ...... Cinnamomum cassia Blume. Cinnamon, Saigon ...... Cinnamomum loureirii Nees. Clary (clary sage) ...... Salvia sclarea L. Clover ...... Trifolium spp. Cloves ...... Eugenia caryophyllata Thunb. Coriander ...... Coriandrum sativum L. Cumin (cummin) ...... Cuminum cyminum L. Cumin, black (black caraway) ...... Nigella sativa L. Dill ...... Anethum graveolens L. Elder flowers ...... Sambucus canadensis L. Fennel, common ...... Foeniculum vulgare Mill. Fennel, sweet (finocchio, Florence fennel) ...... Foeniculum vulgare Mill. var. duice (DC.) Alex. Fenugreek ...... Trigonella foenum-graecum L. Galanga (galangal) ...... Alpina officinarum Hance. Garlic ...... Allium sativum L. Geranium ...... Pelargonium spp. Ginger ...... Zingiber officinale Rosc. Glycyrrhiza ...... Glycyrrhiza glabra L. and other spp. of Glycyrrhiza. Grains of paradise ...... Amomum melegueta Rosc. Horehound (hoarhound) ...... Marrubium vulgare L. Horseradish ...... Armoracia lapathifolia Gilib. Hyssop ...... Hyssopus officinalis L. Lavender ...... Lavandula officinalis Chaix. Licorice ...... Glycyrrhiza glabra L. and other spp. of Glycyrrhiza. Linden flowers ...... Tilia spp. Mace ...... Myristica fragrans Houtt. Marigold, pot ...... Calendula officinalis L. Marjoram, pot ...... Majorana onites (L.) Benth. Marjoram, sweet ...... Majorana hortensis Moench. Mustard, black or brown ...... Brassica nigra (L.) Koch. Mustard, brown ...... Brassica juncea (L.) Coss. Mustard, white or yellow ...... Brassica hirta Moench. Nutmeg ...... Myristica fragrans Houtt. Oregano (oreganum, Mexican oregano, Mexican sage, origan) Lippia spp. Paprika ...... Capsicum annuum L. Parsley ...... Petroselinum crispum (Mill.) Mansf. Pepper, black ...... Piper nigrum L. Pepper, cayenne ...... Capsicum frutescens L. or Capsicum annuum L. Pepper, red ...... Do.

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Common name Botanical name of plant source

Pepper, white ...... Piper nigrum L. Peppermint ...... Mentha piperita L. Poppy seed ...... Papaver somniferum L. Pot marigold ...... Calendula officinalis L. Pot marjoram ...... Majorana onites (L.) Benth. Rosemary ...... Rosmarinus officinalis L. Rue ...... Ruta graveolens L. Saffron ...... Crocus sativus L. Sage ...... Salvia officinalis L. Sage, Greek ...... Salvia triloba L. Savory, summer ...... Satureia hortensis L. (Satureja). Savory, winter ...... Satureia montana L. (Satureja). Sesame ...... Sesamum indicum L. Spearmint ...... Mentha spicata L. Star anise ...... Illicium verum Hook. f. Tarragon ...... Artemisia dracunculus L. Thyme ...... Thymus vulgaris L. Thyme, wild or creeping ...... Thymus serpyllum L. Turmeric ...... Curcuma longa L. Vanilla ...... Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore. Zedoary ...... Curcuma zedoaria Rosc.

§ 582.20 Essential oils, oleoresins (sol- ing distillates) that are generally rec- vent-free), and natural extractives ognized as safe for their intended use, (including distillates). within the meaning of section 409 of Essential oils, oleoresins (solvent- the act, are as follows: free), and natural extractives (includ-

Common name Botanical name of plant source

Alfalfa ...... Medicago sativa L. Allspice ...... Pimenta officinalis Lindl. Almond, bitter (free from prussic acid) ...... Prunus amygdalus Batsch, Prunus armeniaca L. or Prunus persica (L.) Batsch. Ambrette (seed) ...... Hibiscus moschatus Moench. Angelica root ...... Angelica archangelica L. Angelica seed ...... Do. Angelica stem ...... Do. Angostura (cusparia bark) ...... Galipea officinalis Hancock. Anise ...... Pimpinella anisum L. Asafetida ...... Ferula assa-foetida L. and related spp. of Ferula. Balm (lemon balm) ...... Melissa officinalis L. Balsam of Peru ...... Myroxylon pereirae Klotzsch. Basil ...... Ocimum basilicum L. Bay leaves ...... Laurus nobilis L. Bay (myrcia oil) ...... Pimenta racemosa (Mill.) J. W. Moore. Bergamot (bergamot orange) ...... Citrus aurantium L. subsp. bergamia Wright et Arn. Bitter almond (free from prussic acid) ...... Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus persica (L.) Batsch. Bois de rose ...... Aniba rosaeodora Ducke. Cacao ...... Theobroma cacao L. Camomile (chamomile) flowers, Hungarian ...... Matricaria chamomilla L. Camomile (chamomile) flowers, Roman or English ...... Anthemis nobilis L. Cananga ...... Cananga odorata Hook. f. and Thoms. Capsicum ...... Capsicum frutescens L. and Capsicum annuum L. Caraway ...... Carum carvi L. Cardamom seed (cardamon) ...... Elettaria cardamomum Maton. Carob bean ...... Ceratonia siliqua L. Carrot ...... Daucus carota L. Cascarilla bark ...... Croton eluteria Benn. Cassia bark, Chinese ...... Cinnamomum cassia Blume. Cassia bark, Padang or Batavia ...... Cinnamomum burmanni Blume. Cassia bark, Saigon ...... Cinnamomum loureirii Nees. Celery seed ...... Apium graveolens L. Cherry, wild, bark ...... Prunus serotina Ehrh. Chervil ...... Anthriscus cerefolium (L.) Hoffm. Chicory ...... Cichorium intybus L. Cinnamon bark, Ceylon ...... Cinnamomum zeylanicum Nees. Cinnamon bark, Chinese ...... Cinnamomum cassia Blume. Cinnamon bark, Saigon ...... Cinnamomum loureirii Nees.

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Common name Botanical name of plant source

Cinnamon leaf, Ceylon ...... Cinnamomum zeylanicum Nees. Cinnamon leaf, Chinese ...... Cinnamomum cassia Blume. Cinnamon leaf, Saigon ...... Cinnamomum loureirii Nees. Citronella ...... Cymbopogon nardus Rendle. Citrus peels ...... Citrus spp. Clary (clary sage) ...... Salvia sclarea L. Clove bud ...... Eugenia caryophyllata Thunb. Clove leaf ...... Do. Clove stem ...... Do. Clover ...... Trifolium spp. Coca (decocainized) ...... Erythroxylum coca Lam. and other spp. of Erythroxylum. Coffee ...... Coffea spp. Cola nut ...... Cola acuminata Schott and Endl., and other spp. of Cola. Coriander ...... Coriandrum sativum L. Corn silk ...... Zea mays L. Cumin (cummin) ...... Cuminum cyminum L. Curacao orange peel (orange, bitter peel) ...... Citrus aurantium L. Cusparia bark ...... Galipea officinalis Hancock. Dandelion ...... Taraxacum officinale Weber and T. laevigatum DC. Dandelion root ...... Do. Dill ...... Anethum graveolens L. Dog grass (quackgrass, triticum) ...... Agropyron repens (L.) Beauv. Elder flowers ...... Sambucus canadensis L. and S. nigra L. Estragole (esdragol, esdragon, tarragon) ...... Artemisia dracunculus L. Estragon (tarragon) ...... Do. Fennel, sweet ...... Foeniculum vulgare Mill. Fenugreek ...... Trigonella foenum-graecum L. Galanga (galangal) ...... Alpinia officinarum Hance. Garlic ...... Allium sativum L. Geranium ...... Pelargonium spp. Geranium, East Indian ...... Cymbopogon martini Stapf. Geranium, rose ...... Pelargonium graveolens L’Her. Ginger ...... Zingiber officinale Rosc. Glycyrrhiza ...... Glycyrrhiza glabra L. and other spp. of Glycyrrhiza. Glycyrrhizin, ammoniated ...... Do. Grapefruit ...... Citrus paradisi Macf. Guava ...... Psidium spp. Hickory bark ...... Carya spp. Horehound (hoarhound) ...... Marrubium vulgare L. Hops ...... Humulus lupulus L. Horsemint ...... Monarda punctata L. Hyssop ...... Hyssopus officinalis L. Immortelle ...... Helichrysum augustifolium DC. Jasmine ...... Jaminum officinale L. and other spp. of Jasminum. Juniper (berries) ...... Juniperus communis L. Kola nut ...... Cola acuminata Schott and Endl., and other spp. of Cola. Laurel berries ...... Laurus nobilis L. Laurel leaves ...... Laurus spp. Lavender ...... Lavandula officinalis Chaix. Lavender, spike ...... Lavandula latifolia Vill. Lavandin ...... Hybrids between Lavandula officinalis Chaix and Lavandula latifolin Vill. Lemon ...... Citrus limon (L.) Burm. f. Lemon balm (see balm). Lemon grass ...... Cymbopogon citratus DC. and Cymbopogon flexuosus Stapf. Lemon peel ...... Citrus limon (L.) Burm. f. Licorice ...... Glycyrrhiza glabra L. and other spp. of Glycyrrhiza. Lime ...... Citrus aurantifolia Swingle. Linden flowers ...... Tilia spp. Locust bean ...... Ceratonia siliqua L. Lupulin ...... Humulus lupulus L. Mace ...... Myristica fragrans Houtt. Malt (extract) ...... Hordeum vulgare L., or other grains. Mandarin ...... Citrus reticulata Blanco. Marjoram, sweet ...... Majorana hortensis Moench. Mate 1 ...... Ilex paraguariensis St. Hil. Melissa (see balm). Menthol ...... Mentha spp. Menthyl acetate ...... Do. Molasses (extract) ...... Saccharum officinarum L. Mustard ...... Brassica spp. Naringin ...... Citrus paradisi Macf. Neroli, bigarade ...... Citrus aurantium L. Nutmeg ...... Myristica fragrans Houtt.

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Common name Botanical name of plant source

Onion ...... Allium cepa L. Orange, bitter, flowers ...... Citrus aurantium L. Orange, bitter, peel ...... Do. Orange leaf ...... Citrus sinensis (L.) Osbeck. Orange, sweet ...... Do. Orange, sweet, flowers ...... Do. Orange, sweet, peel ...... Do. Origanum ...... Origanum spp. Palmarosa ...... Cymbopogon martini Stapf. Paprika ...... Capsicum annuum L. Parsley ...... Petroselinum crispum (Mill.) Mansf. Pepper, black ...... Piper nigrum L. Pepper, white ...... Piper nigrum L. Peppermint ...... Mentha piperita L. Peruvian balsam ...... Myroxylon pereirae Klotzsch. Petitgrain ...... Citrus aurantium L. Petitgrain lemon ...... Citrus limon (L.) Burm. f. Petitgrain mandarin or tangerine ...... Citrus reticulata Blanco. Pimenta ...... Pimenta officinalis Lindl. Pimenta leaf ...... Primenta officinalis Lindl. Pipsissewa leaves ...... Chimaphila umbellata Nutt. Pomegranate ...... Punica granatum L. Prickly ash bark ...... Xanthoxylum (or Zanthoxylum) Americanum Mill. or Xanthoxylum clava-herculis L. Rose absolute ...... Rosa alba L., Rosa centifolia L., Rosa damascena Mill., Rosa gallica L., and vars. of these spp. Rose (otto of roses, attar of roses) ...... Do. Rose buds ...... Do. Rose flowers ...... Do. Rose fruit (hips) ...... Do. Rose geranium ...... Pelargonium graveolens L’Her. Rose leaves ...... Rosa spp. Rosemary ...... Rosmarinus officinalis L. Rue ...... Ruta graveolens L. Saffron ...... Crocus sativus L. Sage ...... Salvia officinalis L. Sage, Greek ...... Salvia triloba L. Sage, Spanish ...... Salvia lavandulaefolia Vahl. St. John’s bread ...... Ceratonia siliqua L. Savory, summer ...... Satureia hortensis L. Savory, winter ...... Satureia montana L. Schinus molle ...... Schinus molle L. Sloe berries (blackthorn berries) ...... Prunus spinosa L. Spearmint ...... Mentha spicata L. Spike lavender ...... Lavandula latifolia Vill. Tamarind ...... Tamarindus indica L. Tangerine ...... Citrus reticulata Blanco. Tannic acid ...... Nutgalls of Quercus infectoria Oliver and related spp. of Quercus. Also in many other plants. Tarragon ...... Artemisia dracunculus L. Tea ...... Thea sinensis L. Thyme ...... Thymus vulgaris L. and Thymus zygis var. gracilis Boiss. Thyme, white ...... Do. Thyme, wild or creeping ...... Thymus serpyllum L. Triticum (see dog grass). Tuberose ...... Polianthes tuberosa L. Turmeric ...... Curcuma longa L. Vanilla ...... Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore. Violet flowers ...... Viola odorata L. Violet leaves ...... Do. Violet leaves absolute ...... Do. Wild cherry bark ...... Prunus serotina Ehrh. Ylang-ylang ...... Cananga odorata Hook. f. and Thoms. Zedoary bark ...... Curcuma zedoaria Rosc.

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§ 582.30 Natural substances used in seasonings and flavorings that are gen- conjunction with spices and other erally recognized as safe for their in- natural seasonings and flavorings. tended use, within the meaning of sec- Natural substances used in conjunction 409 of the act, are as follows: tion with spices and other natural

Common name Botanical name of plant source

Algae, brown (kelp) ...... Laminaria spp. and Nereocystis spp. Algae, red ...... Porphyra spp. and Rhodymenia palmata (L.) Grev. Dulse ...... Rhodymenia palmata (L.)

§ 582.40 Natural extractives (solvent- seasonings, and flavorings that are free) used in conjunction with generally recognized as safe for their spices, seasonings, and flavorings. intended use, within the meaning of Natural extractives (solvent-free) section 409 of the act, are as follows: used in conjunction with spices,

Common name Botanical name of plant source

Algae, brown ...... Laminaria spp. and Nereocystis spp. Algae, red ...... Porphyra spp. and Rhodymenia palmata (L.) Grev. Apricot kernel (persic oil) ...... Prunus armeniaca L. Dulse ...... Rhodymenia palmata (L.) Grev. Kelp (see algae, brown). Peach kernel (persic oil) ...... Prunus persica Sieb. et Zucc. Peanut stearine ...... Arachis hypogaea L. Persic oil (see apricot kernel and peach kernel). Quince seed ...... Cydonia oblonga Miller.

§ 582.50 Certain other spices, tracts that are generally recognized as seasonings, essential oils, safe for their intended use, within the oleoresins, and natural extracts. meaning of section 409 of the act, are Certain other spices, seasonings, es- as follows: sential oils, oleoresins, and natural ex-

Common name Derivation

Ambergris ...... Physeter macrocephalus L. Castoreum ...... Castor fiber L. and C. canadensis Kuhl. Civet (zibeth, zibet, zibetum) ...... Civet cats, Viverra civetta Schreber and Viverra zibetha Schreber. Cognac oil, white and green ...... Ethyl oenanthate, so-called. Musk (Tonquin musk) ...... Musk deer, Moschus moschiferus L.

§ 582.60 Synthetic flavoring substances Cinnamaldehyde (cinnamic aldehyde). and adjuvants. Citral (2,6-dimethyloctadien-2,6-al-8, geranial, neral). Synthetic flavoring substances and Decanal (N-decylaldhehyde, capraldehyde, adjuvants that are generally recog- capric aldehyde, caprinaldehyde, aldehyde nized as safe for their intended use, C-10). within the meaning of section 409 of Diacetyl (2,3-butandeione). Ethyl acetate. the act, are as follows: Ethyl butyrate. Acetaldehyde (ethanal). 3-Methyl-3-phenyl glycidic acid ethyl ester Acetoin (acetyl methylcarbinol). (ethyl-methyl-phenyl-glycidate, so-called Aconitic acid (equisetic acid, citridic acid, strawberry aldehyde, C-16 aldehyde). achilleic acid). Ethyl vanillin. Anethole (parapropenyl anisole). Eugenol. Benzaldehyde (benzoic aldehyde). Geranoil (3,7-dimethyl-2,6 and 3,6-octadien-1- N-Butyric acid (butanoic acid). ol). d- or l-Carvone (carvol). Geranyl acetate (geraniol acetate).

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Glycerol (glyceryl) tributyrate (tributyrin, § 582.99 Adjuvants for pesticide chemi- butyrin). cals. Limonene (d-, l-, and dl-). Linalool (linalol, 3,7-dimethyl-1,6-octadien-3- Adjuvants, identified and used in ac- ol). cordance with 40 CFR 180.1001(c) and Linalyl acetate (bergamol). (d), which are added to pesticide use di- 1-Malic acid. lutions by a grower or applicator prior Methyl anthranilate (methyl-2- to application to the raw agricultural aminobenzoate). Piperonal (3,4-methylenedioxy-benzaldehyde, commodity, are exempt from the re- heliotropin). quirement of tolerances under section Vanillin. 409 of the act.

§ 582.80 Trace minerals added to ani- Subpart B—General Purpose Food mal feeds. Additives These substances added to animal feeds as nutritional dietary supple- § 582.1005 Acetic acid. ments are generally recognized as safe (a) Product. Acetic acid. when added at levels consistent with (b) Conditions of use. This substance good feeding practice. 1 is generally recognized as safe when Element Source compounds used in accordance with good manufacturing or feeding practice. Cobalt ...... Cobalt acetate. Cobalt carbonate. Cobalt chloride. § 582.1009 Adipic acid. Cobalt oxide. (a) Product. Adipic acid. Cobalt sulfate. Copper ...... Copper carbonate. (b) [Reserved] Copper chloride. (c) Limitations, restrictions, or expla- Copper gluconate. Copper hydroxide. nation. This substance is generally rec- Copper orthophosphate. ognized as safe when used as a buffer Copper oxide. and neutralizing agent in accordance Copper pyrophosphate. Copper sulfate. with good manufacturing or feeding Iodine ...... Calcium iodate. practice. Calcium iodobehenate. Cuprous iodide. § 582.1033 Citric acid. 3,5-Diiodosalicylic acid. Ethylenediamine dihydroiodide. (a) Product. Citric acid. Potassium iodate. (b) Conditions of use. This substance Potassium iodide. Sodium iodate. is generally recognized as safe when Sodium iodide. used in accordance with good manufac- Thymol iodide. turing or feeding practice. Iron ...... Iron ammonium citrate. Iron carbonate. Iron chloride. § 582.1057 Hydrochloric acid. Iron gluconate. Iron oxide. (a) Product. Hydrochloric acid. Iron phosphate. (b) [Reserved] Iron pyrophosphate. (c) Limitations, restrictions, or expla- Iron sulfate. Reduced iron. nation. This substance is generally rec- Manganese ...... Manganese acetate. ognized as safe when used as a buffer Manganese carbonate. and neutralizing agent in accordance Manganese citrate (soluble). Manganese chloride. with good manufacturing or feeding Manganese gluconate. practice. Manganese orthophosphate. Manganese phosphate (dibasic). § 582.1061 Lactic acid. Manganese sulfate. Manganous oxide. (a) Product. Lactic acid. Zinc ...... Zinc acetate. Zinc carbonate. (b) Conditions of use. This substance Zinc chloride. is generally recognized as safe when Zinc oxide. used in accordance with good manufac- Zinc sulfate. turing or feeding practice.

§ 582.1069 Malic acid. 1 All substances listed may be in anhydrous or hydrated form. (a) Product. Malic acid.

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(b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.1073 Phosphoric acid. § 582.1129 Aluminum potassium sul- (a) Product. Phosphoric acid. fate. (b) Conditions of use. This substance (a) Product. Aluminum potassium sul- is generally recognized as safe when fate. used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when used in accordance with good manufac- § 582.1077 Potassium acid tartrate. turing or feeding practice. (a) Product. Potassium acid tartrate. (b) Conditions of use. This substance § 582.1131 Aluminum sodium sulfate. is generally recognized as safe when (a) Product. Aluminum sodium sul- used in accordance with good manufac- fate. turing or feeding practice. (b) Conditions of use. This substance § 582.1087 Sodium acid pyrophosphate. is generally recognized as safe when used in accordance with good manufac- (a) Product. Sodium acid turing or feeding practice. pyrophosphate. (b) Conditions of use. This substance § 582.1135 Ammonium bicarbonate. is generally recognized as safe when used in accordance with good manufac- (a) Product. Ammonium bicarbonate. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.1091 Succinic acid. used in accordance with good manufac- (a) Product. Succinic acid. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.1137 Ammonium carbonate. used in accordance with good manufac- (a) Product. Ammonium carbonate. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.1095 Sulfuric acid. used in accordance with good manufac- (a) Product. Sulfuric acid. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.1139 Ammonium hydroxide. used in accordance with good manufac- (a) Product. Ammonium hydroxide. turing or feeding practice. (b) Conditions of use. This substance § 582.1099 Tartaric acid. is generally recognized as safe when used in accordance with good manufac- (a) Product. Tartaric acid. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.1141 Ammonium phosphate. used in accordance with good manufacturing or feeding practice. (a) Product. Ammonium phosphate (mono- and dibasic). § 582.1125 Aluminum sulfate. (b) Conditions of use. This substance (a) Product. Aluminum sulfate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufacturing or feeding practice. § 582.1143 Ammonium sulfate. (a) Product. Ammonium sulfate. § 582.1127 Aluminum ammonium sul- (b) Conditions of use. This substance fate. is generally recognized as safe when (a) Product. Aluminum ammonium used in accordance with good manufac- sulfate. turing or feeding practice.

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§ 582.1155 Bentonite. (b) Conditions of use. This substance (a) Product. Bentonite. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufac- § 582.1217 Calcium phosphate. turing or feeding practice. (a) Product. Calcium phosphate § 582.1165 Butane. (mono-, di-, and tribasic). (a) Product. Butane. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice. § 582.1235 Caramel. § 582.1191 Calcium carbonate. (a) Product. Caramel. (a) Product. Calcium carbonate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice. § 582.1240 Carbon dioxide. § 582.1193 Calcium chloride. (a) Product. Carbon dioxide. (a) Product. Calcium chloride. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice. § 582.1275 Dextrans. § 582.1195 Calcium citrate. (a) Product. Dextrans of average mo- (a) Product. Calcium citrate. lecular weight below 100,000. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.1199 Calcium gluconate. § 582.1320 Glycerin. (a) Product. Calcium gluconate. (a) Product. Glycerin. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.1205 Calcium hydroxide. § 582.1324 Glyceryl monostearate. (a) Product. Calcium hydroxide. (a) Product. Glyceryl monostearate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.1207 Calcium lactate. § 582.1355 Helium. (a) Product. Calcium lactate. (a) Product. Helium. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.1210 Calcium oxide. § 582.1366 Hydrogen peroxide. (a) Product. Calcium oxide. (a) Product. Hydrogen peroxide.

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(b) [Reserved] used in accordance with good manufac- (c) Limitations, restrictions, or expla- turing or feeding practice. nation. This substance is generally recognized as safe when used as a bleach- § 582.1540 Nitrogen. ing agent in accordance with good (a) Product. Nitrogen. manufacturing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.1400 Lecithin. used in accordance with good manufac- (a) Product. Lecithin. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.1585 Papain. used in accordance with good manufac- (a) Product. Papain. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.1425 Magnesium carbonate. used in accordance with good manufac- (a) Product. Magnesium carbonate. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.1613 Potassium bicarbonate. used in accordance with good manufac- (a) Product. Potassium bicarbonate. turing or feeding practice. (b) Conditions of use. This substance § 582.1428 Magnesium hydroxide. is generally recognized as safe when used in accordance with good manufac- (a) Product. Magnesium hydroxide. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.1619 Potassium carbonate. used in accordance with good manufacturing or feeding practice. (a) Product. Potassium carbonate. (b) Conditions of use. This substance § 582.1431 Magnesium oxide. is generally recognized as safe when used in accordance with good manufac- (a) Product. Magnesium oxide. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.1625 Potassium citrate. used in accordance with good manufacturing or feeding practice. (a) Product. Potassium citrate. (b) Conditions of use. This substance § 582.1480 Methylcellulose. is generally recognized as safe when (a) Product. U.S.P. methylcellulose, used in accordance with good manufac- except that the methoxy content shall turing or feeding practice. not be less than 27.5 percent and not § 582.1631 Potassium hydroxide. more than 31.5 percent on a dry-weight basis. (a) Product. Potassium hydroxide. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.1500 Monoammonium glutamate. § 582.1643 Potassium sulfate. (a) Product. Monoammonium glu- (a) Product. Potassium sulfate. tamate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice. § 582.1655 Propane. § 582.1516 Monopotassium glutamate. (a) Product. Propane. (a) Product. Monopotassium glu- (b) Conditions of use. This substance tamate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice.

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§ 582.1666 Propylene glycol. carboxymethyl groups per (a) Product. Propylene glycol. anhydroglucose unit, and with a min- (b) Conditions of use. This substance imum viscosity of 25 centipoises for 2 is generally recognized as safe (except percent by weight aqueous solution at 25 °C. in cat food) when used in accordance (b) Conditions of use. This substance with good manufacturing or feeding is generally recognized as safe when practice. used in accordance with good manufac- [41 FR 38657, Sept. 10, 1976, as amended at 61 turing or feeding practice. FR 19544, May 2, 1996] § 582.1748 Sodium caseinate. § 582.1685 Rennet. (a) Product. Sodium caseinate. (a) Product. Rennet (rennin). (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice. § 582.1751 Sodium citrate. § 582.1711 Silica aerogel. (a) Product. Sodium citrate. (a) Product. Silica aerogel as a finely (b) Conditions of use. This substance powdered microcellular silica foam is generally recognized as safe when having a minimum silica content of used in accordance with good manufac- 89.5 percent. turing or feeding practice. (b) [Reserved] (c) Limitations, restrictions, or expla- § 582.1763 Sodium hydroxide. nation. This substance is generally rec- (a) Product. Sodium hydroxide. ognized as safe when used as a compo- (b) Conditions of use. This substance nent of antifoaming agents in accord- is generally recognized as safe when ance with good manufacturing or feed- used in accordance with good manufac- ing practice. turing or feeding practice.

§ 582.1721 Sodium acetate. § 582.1775 Sodium pectinate. (a) Product. Sodium acetate. (a) Product. Sodium pectinate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.1736 Sodium bicarbonate. § 582.1778 Sodium phosphate. (a) Product. Sodium bicarbonate. (a) Product. Sodium phosphate (b) Conditions of use. This substance (mono-, di-, and tribasic). is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufacturing or feeding practice. § 582.1742 Sodium carbonate. (a) Product. Sodium carbonate. § 582.1781 Sodium aluminum phos- (b) Conditions of use. This substance phate. is generally recognized as safe when (a) Product. Sodium aluminum phos- used in accordance with good manufac- phate. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.1745 Sodium used in accordance with good manufac- carboxymethylcellulose. turing or feeding practice. (a) Product. Sodium carboxymethylcellulose is the sodium salt of § 582.1792 Sodium sesquicarbonate. carboxymethylcellulose not less than (a) Product. Sodium sesquicarbonate. 99.5 percent on a dry-weight basis, with (b) Conditions of use. This substance maximum substitution of 0.95 is generally recognized as safe when

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used in accordance with good manufac- in accordance with good manufacturing turing or feeding practice. or feeding practice.

§ 582.1804 Sodium potassium tartrate. § 582.2227 Calcium silicate. (a) Product. Sodium potassium tar- (a) Product. Calcium silicate. trate. (b) Tolerance. 2 percent and 5 percent. (b) Conditions of use. This substance (c) Limitations, restrictions, or expla- is generally recognized as safe when nation. This substance is generally rec- used in accordance with good manufac- ognized as safe when used at levels not turing or feeding practice. exceeding 2 percent in table salt and 5 percent in baking powder in accordance § 582.1810 Sodium tripolyphosphate. with good manufacturing or feeding (a) Product. Sodium practice. tripolyphosphate. (b) Conditions of use. This substance § 582.2437 Magnesium silicate. is generally recognized as safe when (a) Product. Magnesium silicate. used in accordance with good manufac- (b) Tolerance. 2 percent. turing or feeding practice. (c) Limitations, restrictions, or expla- § 582.1901 Triacetin. nation. This substance is generally recognized as safe when used in table salt (a) Product. Triacetin (glyceryl in accordance with good manufacturing triacetate). or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.2727 Sodium aluminosilicate. used in accordance with good manufacturing or feeding practice. (a) Product. Sodium aluminosilicate (sodium silicoaluminate). § 582.1973 Beeswax. (b) Tolerance. This substance is generally recognized as safe for use at a (a) Product. Beeswax (yellow wax). level not exceeding 2 percent in accord- (b) Conditions of use. This substance ance with good manufacturing or feed- is generally recognized as safe when ing practice. used in accordance with good manufacturing or feeding practice. § 582.2729 Hydrated sodium calcium aluminosilicate. § 582.1975 Bleached beeswax. (a) Product. Hydrated sodium calcium (a) Product. Bleached beeswax (white aluminosilicate (sodium calcium wax). silicoaluminate). (b) Conditions of use. This substance is generally recognized as safe when (b) Tolerance. This substance is gen- used in accordance with good manufac- erally recognized as safe for use at a turing or feeding practice. level not exceeding 2 percent in accordance with good manufacturing or feed- § 582.1978 Carnauba wax. ing practice. (a) Product. Carnauba wax. § 582.2906 Tricalcium silicate. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Tricalcium silicate. used in accordance with good manufac- (b) Tolerance. 2 percent. turing or feeding practice. (c) Limitations, restrictions, or explanation. This substance is generally rec- Subpart C—Anticaking Agents ognized as safe when used in table salt in accordance with good manufacturing § 582.2122 Aluminum calcium silicate. or feeding practice. (a) Product. Aluminum calcium silicate. Subpart D—Chemical (b) Tolerance. 2 percent. Preservatives (c) Limitations, restrictions, or explanation. This substance is generally rec- § 582.3013 Ascorbic acid. ognized as safe when used in table salt (a) Product. Ascorbic acid.

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(b) Conditions of use. This substance is not over 0.02 percent of fat or oil is generally recognized as safe when content, including essential (volatile) used in accordance with good manufac- oil content of food provided the sub- turing or feeding practice. stance is used in accordance with good manufacturing or feeding practice. § 582.3021 Benzoic acid. (a) Product. Benzoic acid. § 582.3173 Butylated hydroxytoluene. (b) Tolerance. This substance is gen- (a) Product. Butylated hydroxytol- erally recognized as safe for use at a uene. level not exceeding 0.1 percent in ac- (b) Tolerance. This substance is gen- cordance with good manufacturing or erally recognized as safe for use in food feeding practice. when the total content of antioxidants is not over 0.02 percent of fat or oil § 582.3041 Erythorbic acid. content, including essential (volatile) (a) Product. Erythorbic acid. oil content of food provided the sub- (b) Conditions of use. This substance stance is used in accordance with good is generally recognized as safe when manufacturing or feeding practice. used in accordance with good manufacturing or feeding practice. § 582.3189 Calcium ascorbate. (a) Product. Calcium ascorbate. § 582.3081 Propionic acid. (b) Conditions of use. This substance (a) Product. Propionic acid. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufacturing or feeding practice. § 582.3221 Calcium propionate. (a) Product. Calcium propionate. § 582.3089 Sorbic acid. (b) Conditions of use. This substance (a) Product. Sorbic acid. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufacturing or feeding practice. § 582.3225 Calcium sorbate. (a) Product. Calcium sorbate. § 582.3109 Thiodipropionic acid. (b) Conditions of use. This substance (a) Product. Thiodipropionic acid. is generally recognized as safe when (b) Tolerance. This substance is gen- used in accordance with good manufac- erally recognized as safe for use in food turing or feeding practice. when the total content of antioxidants is not over 0.02 percent of fat or oil § 582.3280 Dilauryl thiodipropionate. content including essential (volatile) (a) Product. Dilauryl oil content of the food, provided the thiodipropionate. substance is used in accordance with (b) Tolerance. This substance is gen- good manufacturing or feeding prac- erally recognized as safe for use in food tice. when the total content of antioxidants is not over 0.02 percent of fat or oil § 582.3149 Ascorbyl palmitate. content, including essential (volatile) (a) Product. Ascorbyl palmitate. oil content of the food, provided the (b) Conditions of use. This substance substance is used in accordance with is generally recognized as safe when good manufacturing or feeding prac- used in accordance with good manufac- tice. turing or feeding practice. § 582.3336 Gum guaiac. § 582.3169 Butylated hydroxyanisole. (a) Product. Gum guaiac. (a) Product. Butylated hydroxy- (b) Tolerance. 0.1 percent (equivalent anisole. antioxidant activity 0.01 percent). (b) Tolerance. This substance is gen- (c) Limitations, restrictions, or expla- erally recognized as safe for use in food nation. This substance is generally rec- when the total content of antioxidants ognized as safe when used in edible fats

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or oils in accordance with good manu- cordance with good manufacturing or facturing or feeding practice. feeding practice.

§ 582.3490 Methylparaben. § 582.3731 Sodium ascorbate. (a) Product. Methylparaben (methyl (a) Product. Sodium ascorbate. p-hydroxybenzoate). (b) Conditions of use. This substance (b) Tolerance. This substance is gen- is generally recognized as safe when erally recognized as safe for use at a used in accordance with good manufac- level not exceeding 0.1 percent in ac- turing or feeding practice. cordance with good manufacturing or feeding practice. § 582.3733 Sodium benzoate. § 582.3616 Potassium bisulfite. (a) Product. Sodium benzoate. (b) Tolerance. This substance is gen- (a) Product. Potassium bisulfite. erally recognized as safe for use at a (b) [Reserved] level not exceeding 0.1 percent in ac- (c) Limitations, restrictions, or explanation. This substance is generally rec- cordance with good manufacturing or ognized as safe when used in accord- feeding practice. ance with good manufacturing or feed- § 582.3739 Sodium bisulfite. ing practice, except that it is not used in meats or in food recognized as (a) Product. Sodium bisulfite. source of vitamin B1. (b) [Reserved] (c) Limitations, restrictions, or expla- § 582.3637 Potassium metabisulfite. nation. This substance is generally rec- (a) Product. Potassium metabisulfite. ognized as safe when used in accord- (b) [Reserved] ance with good manufacturing or feed- (c) Limitations, restrictions, or expla- ing practice, except that it is not used nation. This substance is generally rec- in meats or in food recognized as ognized as safe when used in accord- source of vitamin B1. ance with good manufacturing or feeding practice, except that it is not used § 582.3766 Sodium metabisulfite. in meats or in food recognized as (a) Product. Sodium metabisulfite. source of vitamin B1. (b) [Reserved] (c) Limitations, restrictions, or expla- § 582.3640 Potassium sorbate. nation. This substance is generally rec- (a) Product. Potassium sorbate. ognized as safe when used in accord- (b) Conditions of use. This substance ance with good manufacturing or feed- is generally recognized as safe when ing practice, except that it is not used used in accordance with good manufac- in meats or in food recognized as turing or feeding practice. source of vitamin B1.

§ 582.3660 Propyl gallate. § 582.3784 Sodium propionate. (a) Product. Propyl gallate. (a) Product. Sodium propionate. (b) Tolerance. This substance is gen- (b) Conditions of use. This substance erally recognized as safe for use in food is generally recognized as safe when when the total content of antioxidants used in accordance with good manufac- is not over 0.02 percent of fat or oil turing or feeding practice. content, including essential (volatile) oil content of the food, provided the § 582.3795 Sodium sorbate. substance is used in accordance with good manufacturing or feeding prac- (a) Product. Sodium sorbate. tice. (b) Conditions of use. This substance is generally recognized as safe when § 582.3670 Propylparaben. used in accordance with good manufac- (a) Product. Propylparaben (propyl p- turing or feeding practice. hydroxybenzoate). (b) Tolerance. This substance is gen- § 582.3798 Sodium sulfite. erally recognized as safe for use at a (a) Product. Sodium sulfite. level not exceeding 0.1 percent in ac- (b) [Reserved]

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(c) Limitations, restrictions, or expla- § 582.4521 Monosodium phosphate de- nation. This substance is generally rec- rivatives of mono- and diglycerides ognized as safe when used in accord- of edible fats or oils, or edible fat- ance with good manufacturing or feed- forming fatty acids. ing practice, except that it is not used (a) Product. Monosodium phosphate in meats or in food recognized as derivatives of mono- and diglycerides source of vitamin B1. of edible fats or oils, or edible fat-forming fatty acids. § 582.3845 Stannous chloride. (b) Conditions of use. This substance (a) Product. Stannous chloride. is generally recognized as safe when (b) Tolerance. This substance is gen- used in accordance with good manufac- erally recognized as safe for use at a turing or feeding practice. level not exceeding 0.0015 percent calculated as tin in accordance with good § 582.4666 Propylene glycol. manufacturing or feeding practice. (a) Product. Propylene glycol. (b) Conditions of use. This substance § 582.3862 Sulfur dioxide. is generally recognized as safe when (a) Product. Sulfur dioxide. used in accordance with good manufac- (b) [Reserved] turing or feeding practice. (c) Limitations, restrictions, or explanation. This substance is generally rec- Subpart F—Nutrients and/or ognized as safe when used in accord- Dietary Supplements 1 ance with good manufacturing or feeding practice, except that it is not used § 582.5013 Ascorbic acid. in meats or in food recognized as source of vitamin B . (a) Product. Ascorbic acid. 1 (b) Conditions of use. This substance § 582.3890 Tocopherols. is generally recognized as safe when used in accordance with good manufac- (a) Product. Tocopherols. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.5017 Aspartic acid. used in accordance with good manufacturing or feeding practice. (a) Product. Aspartic acid (L- and DL- forms). (b) Conditions of use. This substance Subpart E—Emulsifying Agents is generally recognized as safe when § 582.4101 Diacetyl tartaric acid esters used in accordance with good manufac- of mono- and diglycerides of edible turing or feeding practice. fats or oils, or edible fat-forming fatty acids. § 582.5049 Aminoacetic acid. (a) Product. Diacetyl tartaric acid (a) Product. Glycine (aminoacetic esters of mono- and diglycerides of edi- acid). ble fats or oils, or edible fat-forming (b) [Reserved] fatty acids. (c) Limitations, restrictions, or expla- (b) Conditions of use. This substance nation. This substance is generally rec- is generally recognized as safe when ognized as safe when used in animal used in accordance with good manufac- feeds in accordance with good manu- turing or feeding practice. facturing or feeding practice.

§ 582.4505 Mono- and diglycerides of § 582.5065 Linoleic acid. edible fats or oils, or edible fat- (a) Product. Linoleic acid prepared forming acids. from edible fats and oils and free from (a) Product. Mono- and diglycerides of chick-edema factor. edible fats or oils, or edible fat-forming (b) Conditions of use. This substance acids. is generally recognized as safe when (b) Conditions of use. This substance is generally recognized as safe when 1 Amino acids listed in this subpart may be used in accordance with good manufac- free hydrochloride salt, hydrated, or anhy- turing or feeding practice. drous form, where applicable.

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used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when used in accordance with good manufac- § 582.5118 Alanine. turing or feeding practice. (a) Product. Alanine (L- and DL- forms). § 582.5217 Calcium phosphate. (b) Conditions of use. This substance (a) Product. Calcium phosphate is generally recognized as safe when (mono-, di-, and tribasic). used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when used in accordance with good manufac- § 582.5145 Arginine. turing or feeding practice. (a) Product. Arginine (L- and DL- § 582.5223 Calcium pyrophosphate. forms). (b) Conditions of use. This substance (a) Product. Calcium pyrophosphate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufacturing or feeding practice. § 582.5159 Biotin. § 582.5230 Calcium sulfate. (a) Product. Biotin. (b) Conditions of use. This substance (a) Product. Calcium sulfate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufacturing or feeding practice. § 582.5191 Calcium carbonate. § 582.5245 Carotene. (a) Product. Calcium carbonate. (a) Product. Carotene. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice. § 582.5195 Calcium citrate. § 582.5250 Choline bitartrate. (a) Product. Calcium citrate. (a) Product. Choline bitartrate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.5201 Calcium glycerophosphate. § 582.5252 Choline chloride. (a) Product. Calcium (a) Product. Choline chloride. glycerophosphate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice. § 582.5260 Copper gluconate. § 582.5210 Calcium oxide. (a) Product. Copper gluconate. (a) Product. Calcium oxide. (b) Tolerance. This substance is gen- (b) Conditions of use. This substance erally recognized as safe for use at a is generally recognized as safe when level not exceeding 0.005 percent in ac- used in accordance with good manufac- cordance with good manufacturing or turing or feeding practice. feeding practice.

§ 582.5212 Calcium pantothenate. § 582.5271 Cysteine. (a) Product. Calcium pantothenate. (a) Product. Cysteine (L-forms).

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(b) Conditions of use. This substance § 582.5361 Histidine. is generally recognized as safe when (a) Product. Histidine (L- and DL- used in accordance with good manufac- forms). turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.5273 Cystine. used in accordance with good manufac- (a) Product. Cystine (L- and DL- turing or feeding practice. forms). (b) Conditions of use. This substance § 582.5370 Inositol. is generally recognized as safe when (a) Product. Inositol. used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when used in accordance with good manufac- § 582.5301 Ferric phosphate. turing or feeding practice. (a) Product. Ferric phosphate. § 582.5375 Iron reduced. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Iron reduced. used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when used in accordance with good manufac- § 582.5304 Ferric pyrophosphate. turing or feeding practice. (a) Product. Ferric pyrophosphate. § 582.5381 Isoleucine. (b) Conditions of use. This substance (a) Product. Isoleucine (L- and DL- is generally recognized as safe when forms). used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when used in accordance with good manufac- § 582.5306 Ferric sodium turing or feeding practice. pyrophosphate. (a) Product. Ferric sodium § 582.5406 Leucine. pyrophosphate. (a) Product. Leucine (L- and DL- (b) Conditions of use. This substance forms). is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufacturing or feeding practice. § 582.5308 Ferrous gluconate. § 582.5411 Lysine. (a) Product. Ferrous gluconate. (b) Conditions of use. This substance (a) Product. Lysine (L- and DL- is generally recognized as safe when forms). used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when used in accordance with good manufac- § 582.5311 Ferrous lactate. turing or feeding practice. (a) Product. Ferrous lactate. § 582.5431 Magnesium oxide. (b) Conditions of use. This substance (a) Product. Magnesium oxide. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufacturing or feeding practice. § 582.5315 Ferrous sulfate. (a) Product. Ferrous sulfate. § 582.5434 Magnesium phosphate. (b) Conditions of use. This substance (a) Product. Magnesium phosphate is generally recognized as safe when (di- and tribasic). used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when

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used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.5443 Magnesium sulfate. § 582.5470 Mannitol. (a) Product. Magnesium sulfate. (a) Product. Mannitol. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.5446 Manganese chloride. § 582.5475 Methionine. (a) Product. Manganese chloride. (a) Product. Methionine. (b) Conditions of use. This substance (b) [Reserved] is generally recognized as safe when (c) Limitations, restrictions, or expla- used in accordance with good manufac- nation. This substance is generally rec- turing or feeding practice. ognized as safe when used in animal § 582.5449 Manganese citrate. feeds in accordance with good manufacturing or feeding practice. (a) Product. Manganese citrate. (b) Conditions of use. This substance § 582.5477 Methionine hydroxy analog is generally recognized as safe when and its calcium salts. used in accordance with good manufac- (a) Product. Methionine hydroxy ana- turing or feeding practice. log and its calcium salts. § 582.5452 Manganese gluconate. (b) [Reserved] (c) Limitations, restrictions, or expla- (a) Product. Manganese gluconate. nation. This substance is generally rec- (b) Conditions of use. This substance ognized as safe when used in animal is generally recognized as safe when feeds in accordance with good manu- used in accordance with good manufac- facturing or feeding practice. turing or feeding practice. § 582.5530 Niacin. § 582.5455 Manganese glycerophosphate. (a) Product. Niacin. (a) Product. Manganese (b) Conditions of use. This substance glycerophosphate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufac- § 582.5535 Niacinamide. turing or feeding practice. (a) Product. Niacinamide. § 582.5458 Manganese hypophosphite. (b) Conditions of use. This substance (a) Product. Manganese is generally recognized as safe when hypophosphite. used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when used in accordance with good manufac- § 582.5580 D-Pantothenyl alcohol. turing or feeding practice. (a) Product. D-Pantothenyl alcohol. (b) Conditions of use. This substance § 582.5461 Manganese sulfate. is generally recognized as safe when (a) Product. Manganese sulfate. used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when used in accordance with good manufac- § 582.5590 Phenylalanine. turing or feeding practice. (a) Product. Phenylalanine (L- and DL-forms). § 582.5464 Manganous oxide. (b) Conditions of use. This substance (a) Product. Manganous oxide. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice.

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§ 582.5622 Potassium chloride. (b) Conditions of use. This substance (a) Product. Potassium chloride. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufac- § 582.5772 Sodium pantothenate. turing or feeding practice. (a) Product. Sodium pantothenate. § 582.5628 Potassium (b) Conditions of use. This substance glycerophosphate. is generally recognized as safe when (a) Product. Potassium used in accordance with good manufac- glycerophosphate. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.5778 Sodium phosphate. used in accordance with good manufac- (a) Product. Sodium phosphate turing or feeding practice. (mono-, di-, and tribasic). (b) Conditions of use. This substance § 582.5634 Potassium iodide. is generally recognized as safe when (a) Product. Potassium iodide. used in accordance with good manufac- (b) Tolerance. 0.01 percent. turing or feeding practice. (c) Limitations, restrictions, or explanation. This substance is generally rec- § 582.5835 Sorbitol. ognized as safe when used in table salt (a) Product. Sorbitol. as a source of dietary iodine in accord- (b) Conditions of use. This substance ance with good manufacturing or feed- is generally recognized as safe when ing practice. used in accordance with good manufacturing or feeding practice. § 582.5650 Proline. (a) Product. Proline (L- and DL- § 582.5875 Thiamine hydrochloride. forms). (a) Product. Thiamine hydrochloride. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.5676 Pyridoxine hydrochloride. § 582.5878 Thiamine mononitrate. (a) Product. Pyridoxine hydro- (a) Product. Thiamine mononitrate. chloride. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice. § 582.5881 Threonine. § 582.5695 Riboflavin. (a) Product. Threonine (L- and DL- (a) Product. Riboflavin. forms). (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.5697 Riboflavin-5-phosphate. § 582.5890 Tocopherols. (a) Product. Riboflavin-5-phosphate. (a) Product. Tocopherols. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.5701 Serine. § 582.5892 a-Tocopherol acetate. (a) Product. Serine (L- and DL-forms). (a) Product. a-Tocopherol acetate.

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(b) Conditions of use. This substance § 582.5950 Vitamin D 2. is generally recognized as safe when (a) Product. Vitamin D . used in accordance with good manufac- 2 turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.5915 Tryptophane. used in accordance with good manufacturing or feeding practice. (a) Product. Tryptophane (L- and DL- forms). § 582.5953 Vitamin D 3. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Vitamin D3. used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when used in accordance with good manufac- § 582.5920 Tyrosine. turing or feeding practice. (a) Product. Tyrosine (L- and DL- § 582.5985 Zinc chloride. forms). (b) Conditions of use. This substance (a) Product. Zinc chloride. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufacturing or feeding practice. § 582.5925 Valine. § 582.5988 Zinc gluconate. (a) Product. Valine (L- and DL- forms). (a) Product. Zinc gluconate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.5930 Vitamin A. § 582.5991 Zinc oxide. (a) Product. Vitamin A. (a) Product. Zinc oxide. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.5933 Vitamin A acetate. § 582.5994 Zinc stearate. (a) Product. Vitamin A acetate. (a) Product. Zinc stearate prepared (b) Conditions of use. This substance from stearic acid free from chick- is generally recognized as safe when edema factor. used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when used in accordance with good manufac- § 582.5936 Vitamin A palmitate. turing or feeding practice. (a) Product. Vitamin A palmitate. (b) Conditions of use. This substance § 582.5997 Zinc sulfate. is generally recognized as safe when (a) Product. Zinc sulfate. used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when used in accordance with good manufac- § 582.5945 Vitamin B 12. turing or feeding practice. (a) Product. Vitamin B12. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

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Subpart G—Sequestrants 2 (b) Conditions of use. This substance is generally recognized as safe when § 582.6033 Citric acid. used in accordance with good manufac- (a) Product. Citric acid. turing or feeding practice. (b) Conditions of use. This substance § 582.6203 Calcium is generally recognized as safe when hexametaphosphate. used in accordance with good manufacturing or feeding practice. (a) Product. Calcium hexametaphosphate. § 582.6085 Sodium acid phosphate. (b) Conditions of use. This substance (a) Product. Sodium acid phosphate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufac- § 582.6215 Monobasic calcium phos- turing or feeding practice. phate. § 582.6099 Tartaric acid. (a) Product. Monobasic calcium phosphate. (a) Product. Tartaric acid. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.6185 Calcium acetate. § 582.6219 Calcium phytate. (a) Product. Calcium acetate. (a) Product. Calcium phytate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.6193 Calcium chloride. § 582.6285 Dipotassium phosphate. (a) Product. Calcium chloride. (a) Product. Dipotassium phosphate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.6195 Calcium citrate. § 582.6290 Disodium phosphate. (a) Product. Calcium citrate. (a) Product. Disodium phosphate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.6197 Calcium diacetate. § 582.6386 Isopropyl citrate. (a) Product. Calcium diacetate. (a) Product. Isopropyl citrate. (b) Conditions of use. This substance (b) Tolerance. This substance is gen- is generally recognized as safe when erally recognized as safe for use at a used in accordance with good manufac- level not exceeding 0.02 percent in ac- turing or feeding practice. cordance with good manufacturing or feeding practice. § 582.6199 Calcium gluconate. (a) Product. Calcium gluconate. § 582.6511 Monoisopropyl citrate. (a) Product. Monoisopropyl citrate. 2 For the purpose of this subpart, no at- (b) Conditions of use. This substance tempt has been made to designate those is generally recognized as safe when sequestrants that may also function as used in accordance with good manufac- chemical preservatives. turing or feeding practice.

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§ 582.6625 Potassium citrate. (b) Condition of use. This substance is (a) Product. Potassium citrate. generally recognized as safe when used (b) Conditions of use. This substance in accordance with good manufacturing is generally recognized as safe when or feeding practice. used in accordance with good manufac- § 582.6789 Tetra sodium turing or feeding practice. pyrophosphate. [41 FR 38657, Sept. 10, 1976. Redesignated at (a) Product. Tetra sodium 42 FR 14091, Mar. 15, 1977] pyrophosphate. § 582.6751 Sodium citrate. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Sodium citrate. used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when used in accordance with good manufac- § 582.6801 Sodium tartrate. turing or feeding practice. (a) Product. Sodium tartrate. [41 FR 38657, Sept. 10, 1976. Redesignated at (b) Conditions of use. This substance 42 FR 14091, Mar. 15, 1977] is generally recognized as safe when used in accordance with good manufac- § 582.6754 Sodium diacetate. turing or feeding practice. (a) Product. Sodium diacetate. (b) Conditions of use. This substance § 582.6804 Sodium potassium tartrate. is generally recognized as safe when (a) Product. Sodium potassium tar- used in accordance with good manufac- trate. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.6757 Sodium gluconate. used in accordance with good manufac- (a) Product. Sodium gluconate. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.6807 Sodium thiosulfate. used in accordance with good manufac- (a) Product. Sodium thiosulfate. turing or feeding practice. (b) Tolerance. 0.1 percent. § 582.6760 Sodium (c) Limitations, restrictions, or expla- hexametaphosphate. nation. This substance is generally recognized as safe when used in salt in ac- (a) Product. Sodium cordance with good manufacturing or hexametaphosphate. feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.6810 Sodium tripolyphosphate. used in accordance with good manufacturing or feeding practice. (a) Product. Sodium tripolyphosphate. § 582.6769 Sodium metaphosphate. (b) Conditions of use. This substance (a) Product. Sodium metaphosphate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufac- § 582.6851 Stearyl citrate. turing or feeding practice. (a) Product. Stearyl citrate. § 582.6778 Sodium phosphate. (b) Tolerance. This substance is gen- (a) Product. Sodium phosphate erally recognized as safe for use at a (mono-, di-, and tribasic). level not exceeding 0.15 percent in ac- (b) Conditions of use. This substance cordance with good manufacturing or is generally recognized as safe when feeding practice. used in accordance with good manufacturing or feeding practice. Subpart H—Stabilizers § 582.6787 Sodium pyrophosphate. § 582.7115 Agar-agar. (a) Product. Sodium pyrophosphate. (a) Product. Agar-agar.

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§ 582.7133 Ammonium alginate. § 582.7351 Gum tragacanth. (a) Product. Ammonium alginate. (a) Product. Tragacanth (gum (b) Conditions of use. This substance tragacanth). is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufacturing or feeding practice. § 582.7187 Calcium alginate. (a) Product. Calcium alginate. § 582.7610 Potassium alginate. (b) Conditions of use. This substance (a) Product. Potassium alginate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufacturing or feeding practice. § 582.7255 Chondrus extract. (a) Product. Chondrus extract § 582.7724 Sodium alginate. (carrageenin). (a) Product. Sodium alginate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.7330 Gum arabic. PART 584—FOOD SUBSTANCES AF- (a) Product. Acacia (gum arabic). FIRMED AS GENERALLY RECOG- (b) Conditions of use. This substance NIZED AS SAFE IN FEED AND is generally recognized as safe when used in accordance with good manufac- DRINKING WATER OF ANIMALS turing or feeding practice. Subpart A [Reserved] § 582.7333 Gum ghatti. Subpart B—Listing of Specific Substances (a) Product. Gum ghatti. Affirmed as GRAS (b) Conditions of use. This substance is generally recognized as safe when Sec. used in accordance with good manufac- 584.200 Ethyl alcohol containing ethyl ace- turing or feeding practice. tate. 584.700 Hydrophobic silicas. § 582.7339 Guar gum. 584.725 25–Hydroxyvitamin D3. (a) Product. Guar gum. AUTHORITY: 21 U.S.C. 321, 342, 348, 371. (b) Conditions of use. This substance is generally recognized as safe when Subpart A [Reserved] used in accordance with good manufacturing or feeding practice. Subpart B—Listing of Specific Substances Affirmed as GRAS § 582.7343 Locust bean gum. (a) Product. Locust (carob) bean gum. § 584.200 Ethyl alcohol containing (b) Conditions of use. This substance ethyl acetate. is generally recognized as safe when The feed additive ethyl alcohol con- used in accordance with good manufac- taining ethyl acetate meets the re- turing or feeding practice. quirement of 27 CFR 21.62, being not less than 92.5 percent ethyl alcohol, § 582.7349 Sterculia gum. each 100 gallons having had added the (a) Product. Sterculia gum (karaya equivalent of 4.25 gallons of 100 percent gum). ethyl acetate. It is used in accordance

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with good feeding practices in rumi- (c) Limitations. (1) Not to exceed 69 nant feed supplements as a source of parts per billion (ppb) in feed or 34.5 added energy. ppb in drinking water. It shall be used in accordance with good manufacturing [46 FR 52333, Oct. 27, 1981, as amended at 72 FR 41620, July 31, 2007] and feeding practices. (2) The product must comply with § 584.700 Hydrophobic silicas. the following specifications: (a) Product. Amorphous fumed hydro- (i) Not less than 94.0 percent 25- phobic silica or precipitated hydro- hydroxyvitamin D3. phobic silica (CAS Reg. No. 68611–0944– (ii) Not more than 1 percent of any 099, silane, dichlorodimethyl-, reaction individual sterol. products with silica). (iii) Not more than 5 percent water. (b) Conditions of use. An anticaking/ (iv) Not more than 20 parts per mil- free-flow agent in vitamin preparations lion (ppm) lead. for animal feed. (v) Not more than 20 ppm aluminum. (c) Limitations. Not to exceed 5 per- (vi) Not more than 1.0 percent sol- ′ ′ cent in the vitamin preparation. It vents and non-detectable levels of 2 . 4 . ′ ′ shall be used in accordance with good 5 . 7 -tetraiodofluorescin. manufacturing or feeding practices. It (3) Product labeling shall bear the must be of purity suitable for intended following: use, and it must comply with the fol- (i) A statement to indicate that the lowing specifications: maximum use level of 25- (i) Amorphous fumed hydrophobic hydroxyvitamin D3 must not exceed 69 silica: Not less than 99.0 percent silicon ppb in feed or 34.5 ppb in drinking dioxide after ignition. Not more than 3 water. ppm arsenic. Not more than 0.003 per- (ii) Adequate use directions to ensure cent heavy metals (as lead). Not more that 25-hydroxyvitamin D3 (and all pre- than 10 ppm lead. Not more than 2.5 mixes) is uniformly blended through- percent loss on drying. Not more than out the feed or drinking water. 2 percent loss on ignition after drying. (iii) An expiration date on all premix Not more than 1 percent insoluble sub- labeling. stances. Not more than 50 parts per (iv) A statement on all premix label- million dichlorodimethylsilane. ing (feed and drinking water forms) (ii) Precipated hydrophobic silica: that 25-hydroxyvitamin D3 should not Not less than 94.0 percent silicon diox- be used simultaneously in both feed ide after ignition. Not more than 3 ppm and water. arsenic. Not more than 0.003 percent [72 FR 12564, Mar. 16, 2007] heavy metals (as lead). Not more than 10 ppm lead. Not more than 7 percent PART 589—SUBSTANCES PROHIB- loss on drying. Not more than 8.5 percent loss on ignition after drying. Not ITED FROM USE IN ANIMAL FOOD more than 5 percent soluble ionizable OR FEED salts (as sodium sulfate). Not more than 1 percent insoluble substances. Subpart A—General Provisions Not more than 50 parts per million Sec. dichlorodimethylsilane. 589.1 Substances prohibited from use in animal food or feed. [61 FR 43453, Aug. 23, 1996] Subpart B—Listing of Specific Substances § 584.725 25–Hydroxyvitamin D . 3 Prohibited From Use in Animal Food or (a) Product. 25–Hydroxyvitamin D3 Feed (9,10-secocholesta-5,7,10(19)-triene-3b, 25-diol). 589.1000 Gentian violet. (b) Conditions of use. This substance 589.1001 Propylene glycol in or on cat food. is generally recognized as safe as a 589.2000 Animal proteins prohibited in ruminant feed. source of vitamin D3 activity in feed or 589.2001 Cattle materials prohibited in ani- drinking water of broiler chickens mal food or feed to prevent the trans- when used in accordance with the limi- mission of bovine spongiform tations in paragraph (c) of this section. encephalopathy.

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AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 371. tion 409 of the act, unless it is subject to an effective notice of claimed inves- Subpart A—General Provisions tigational exemption for a food additive under § 570.17 of this chapter, or § 589.1 Substances prohibited from use unless the substance is intended for use in animal food or feed. as a new animal drug and is subject to (a) The substances listed in this part an approved application under section have been prohibited from use in ani- 512 of the act, or an index listing under mal food or feed by the Food and Drug section 572 of the act, or an effective Administration because of a deter- notice of claimed investigational ex- mination that they present a potential emption for a new animal drug under risk to the public health or have not part 511 of this chapter or § 516.125 of been shown by adequate scientific data this chapter. to be safe for use in such food or feed. [72 FR 69131, Dec. 6, 2007] Use of any of these substances in violation of this part causes the animal food § 589.1001 Propylene glycol in or on or feed involved to be adulterated and cat food. in violation of the Act. The Food and Drug Administration (b) This part includes only a partial has determined that propylene glycol list of substances prohibited from use in or on cat food has not been shown by in animal food or feed; it is for easy adequate scientific data to be safe for reference purposes and is not a com- use. Use of propylene glycol in or on plete list of substances that may not cat food causes the feed to be adulter- lawfully be used in such animal food or ated and in violation of the Federal feed. No substance may be used in ani- Food, Drug, and Cosmetic Act (the mal food or feed unless it meets all ap- act), in the absence of a regulation pro- plicable requirements of the Act. viding for its safe use as a food additive (c) The Food and Drug Administra- under section 409 of the act, unless it is tion either on its own initiative or on subject to an effective notice of behalf of any interested person who has claimed investigational exemption for submitted a petition, may publish a a food additive under § 570.17 of this proposal to establish, amend, or repeal chapter, or unless the substance is in- a regulation under this part on the tended for use as a new animal drug basis of new scientific evaluation or in- and is subject to an approved applica- formation. Any such petition shall in- tion under section 512 of the act or an clude an adequate scientific basis to effective notice of claimed investiga- support the petition, shall be the form tional exemption for a new animal drug set forth in § 571.1 of this chapter, and under part 511 of this chapter. will be published in the FEDERAL REG- ISTER for comment if it contains rea- [61 FR 19544, May 2, 1996] sonable ground. § 589.2000 Animal proteins prohibited [45 FR 28319, Apr. 29, 1980] in ruminant feed. (a) Definitions—(1) Protein derived from Subpart B—Listing of Specific Sub- mammalian tissues means any protein- stances Prohibited From Use containing portion of mammalian ani- in Animal Food or Feed mals, excluding: Blood and blood products; gelatin; tallow containing no § 589.1000 Gentian violet. more than 0.15 percent insoluble impu- The Food and Drug Administration rities and tallow derivatives as speci- has determined that gentian violet has fied in § 589.2001; inspected meat prod- not been shown by adequate scientific ucts which have been cooked and of- data to be safe for use in animal feed. fered for human food and further heat Use of gentian violet in animal feed processed for feed (such as plate waste causes the feed to be adulterated and in and used cellulosic food casings); milk violation of the Federal Food, Drug, products (milk and milk proteins); and and Cosmetic Act (the act), in the ab- any product whose only mammalian sence of a regulation providing for its protein consists entirely of porcine or safe use as a food additive under sec- equine protein.

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(2) Renderer means any firm or indi- measures to ensure that materials vidual that processes slaughter byprod- identified in paragraph (b) of this sec- ucts, animals unfit for human con- tion are not used in the feed of sumption, or meat scraps. The term in- ruminants: cludes persons who collect such mate- (i) Label the materials as follows: rials and subject them to minimal ‘‘Do not feed to cattle or other processing, or distribute them to firms ruminants’’; and other than renderers (as defined here) (ii) Maintain records sufficient to whose intended use for the products track the materials throughout their may include animal feed. The term in- receipt, processing, and distribution, cludes renderers that also blend animal and make the copies available for in- protein products. spection and copying by the Food and (3) Blender means any firm or indi- Drug Administration. vidual which obtains processed animal (2) Renderers described in paragraph protein from more than one source or (c)(1) of this section will be exempted from more than one species, and subse- from the requirements of paragraphs quently mixes (blends) or redistributes (c)(1)(i) and (c)(1)(ii) of this section if an animal protein product. they: (4) Feed manufacturer includes manu- (i) Use exclusively a manufacturing facturers of complete and intermediate method that has been validated by the feeds intended for animals, and in- Food and Drug Administration to de- cludes on-farm in addition to off-farm activate the agent that causes trans- feed manufacturing and mixing oper- missible spongiform encephalopathy ations. (TSE) and whose design has been made (5) Nonmammalian protein includes available to the public; proteins from nonmammalian animals. (ii) Use routinely a test method that (6) Distributor includes persons who has been validated by the Food and distribute or transport feeds or feed in- Drug Administration to detect the gredients intended for animals. presence of the agent that causes (7) Ruminant includes any member of TSE’s and whose design has been made the order of animals which has a stom- available to the public. Renderers ach with four chambers (rumen, reticu- whose products test positive for agents lum, omasum, and abomasum) through that cause TSE’s must comply with which feed passes in digestion. The paragraphs (c)(1)(i) and (c)(1)(ii) of this order includes, but is not limited to, section. Records of the test results cattle, buffalo, sheep, goats, deer, elk, shall be made available for inspection and antelopes. by the Food and Drug Administration; (b) Food additive status. The Food and or Drug Administration has determined (iii) Use exclusively a method for that protein derived from mammalian controlling the manufacturing process tissues for use in ruminant feed is a that minimizes the risk of the TSE food additive subject to section 409 of agent entering the product and whose the Federal Food, Drug, and Cosmetic design has been made available to the Act (the act). The use or intended use public and validated by the Food and in ruminant feed of any material that Drug Administration. contains protein derived from mamma- (3) Renderers described in paragraph lian tissues causes the feed to be adul- (c)(1) of this section will be exempted terated and in violation of the act, un- from the requirements of paragraph less it is the subject of an effective no- (c)(1)(ii) of this section if they use a tice of claimed investigational exemp- permanent method, approved by FDA, tion for a food additive under § 570.17 of to make a mark indicating that the this chapter. product contains or may contain pro- (c) Requirements for renderers that are tein derived from mammalian tissue. If not included in paragraph (e) of this sec- the marking is by the use of an agent tion. (1) Renderers that manufacture that cannot be detected on visual in- products that contain or may contain spection, the renderer must use an protein derived from mammalian tis- agent whose presence can be detected sues and that are intended for use in by a method that has been validated by animal feed shall take the following the Food and Drug Administration and

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whose design has been made available accordance with paragraph (c) or (d) of to the public. this section, as appropriate. (4) Renderers shall comply with all (5) Copies of certifications as de- applicable requirements under scribed in paragraphs (d)(2) and (d)(3) of § 589.2001. this section, shall be made available (d) Requirements for protein blenders, for inspection and copying by the Food feed manufacturers, and distributors that and Drug Administration. are not included in paragraph (e) of this (e) Requirements for persons that intend section. (1) Protein blenders, feed manu- to separate mammalian and nonmamma- facturers, and distributors that manu- lian materials. (1) Renderers, protein facture, blend, process, and distribute blenders, feed manufacturers, distribu- products that contain or may contain tors, and others that manufacture, protein derived from mammalian tis- process, blend and distribute both prod- sues shall comply with paragraph (c)(1) ucts that contain or may contain proof this section. tein derived from mammalian tissues (2) Protein blenders, feed manufac- or feeds containing such products, and turers, and distributors, shall be ex- protein products from other animal tis- empt from paragraphs (d)(1) of this sec- sues or feeds containing such products, tion if they: and that intend to keep those products separate shall: (i) Purchase animal products from (i) Comply with paragraphs (c)(1) or renderers that certified compliance (d)(1) of this section as appropriate ex- with paragraph (c)(2) of this section or cept that the labeling requirement purchase such materials from parties shall apply only to products that con- that certify that the materials were tain or may contain protein derived purchased from renderers that certified from mammalian tissues or feeds con- compliance with paragraph (c)(2) of taining such products; this section; or (ii) In the case of a renderer, obtain (ii) Comply with the requirements of nonmammalian or pure porcine or pure paragraph (c)(2) of this section where equine materials only from single-spe- appropriate. cies slaughter facilities; (3) Protein blenders, feed manufac- (iii) Provide for measures to avoid turers, and distributors, shall be ex- commingling or cross-contamination; empt from paragraph (c)(1)(ii) of this (A) Maintain separate equipment or section if they: facilities for the manufacture, proc- (i) Purchase animal protein products essing, or blending of such materials; that are marked in accordance with or paragraph (c)(3) of this section or pur- (B) Use clean-out procedures or other chase such materials from renderers means adequate to prevent carry-over that certified compliance with para- of products that contain or may con- graph (c)(3) of this section, or purchase tain protein derived from mammalian such materials from parties that cer- tissues into animal protein or feeds tify that the materials were purchased that may be used for ruminants; and from renderers that certified compli- (iv) Maintain written procedures ance with paragraph (c)(3) of this sec- specifying the clean-out procedures or tion; or other means, and specifying the proce- (ii) Comply with the requirements of dures for separating products that con- paragraph (c)(3) of this section where tain or may contain protein derived appropriate. from mammalian tissue from all other (4) Pet food products that are sold or protein products from the time of re- are intended for sale at retail and feeds ceipt until the time of shipment. for nonruminant laboratory animals (2) Renderers, blenders, feed manu- are exempt from the labeling require- facturers, and distributors will be ex- ments in paragraphs (c) and (d) of this empted from applicable requirements section. However, if the pet food prod- of paragraph (e)(1) of this section, if ucts or feeds for nonruminant labora- they meet the criteria for exemption tory animals are sold or are intended under paragraphs (c)(2) or (c)(3) of this for sale as distressed or salvage items, section, and (d)(2) or (d)(3) of this sec- then such products shall be labeled in tion.

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(3) Renderers shall comply with all (b) Definitions—(1) Cattle materials pro- applicable requirements under hibited in animal feed include: § 589.2001. (i) The entire carcass of BSE-positive (f) Requirements for establishments and cattle; individuals that are responsible for feed- (ii) The brains and spinal cords of ing ruminant animals. Establishments cattle 30 months of age and older; and individuals that are responsible for (iii) The entire carcass of cattle not feeding ruminant animals shall main- inspected and passed for human contain copies of purchase invoices and la- sumption as defined in paragraph (b)(2) beling for all feeds containing animal of this section that are 30 months of protein products received, and make age or older from which brains and spi- the copies available for inspection and nal cords were not effectively removed copying by the Food and Drug Admin- or otherwise effectively excluded from istration. animal feed; (g) Adulteration and misbranding. (1) (iv) Mechanically separated beef as Animal protein products, and feeds defined in paragraph (b)(3) of this sec- containing such products, that are not tion that is derived from materials in compliance with paragraphs (c) specified in paragraphs (b)(1)(i), through (f) of this section, excluding (b)(1)(ii), and (b)(1)(iii) of this section; labeling requirements, will be deemed and adulterated under section 402(a)(2)(C) (v) Tallow as defined in paragraph or 402(a)(4) of the act. (b)(5) of this section that is derived (2) Animal protein products, and from materials specified in paragraphs feeds containing such products, that (b)(1)(i), (b)(1)(ii), and (b)(1)(iii) of this are not in compliance with the labeling section. requirements of paragraphs (c) through (vi) Cattle materials prohibited in (f) of this section will be deemed mis- animal feed do not include: branded under section 403(a)(1) or 403(f) (A) Tallow derivatives as defined in of the act. paragraph (b)(6) of this section; (h) Inspection; records retention. (1) (B) Tallow as defined in paragraph Records that are to be made available (b)(5) of this section that is derived for inspection and copying, as required from materials specified in paragraphs by this section, shall be kept for a min- (b)(1)(ii) and (b)(1)(iii) of this section imum of 1 year. and that contains no more than 0.15 (2) Written procedures required by percent insoluble impurities. Insoluble this section shall be made available for impurities must be measured by the inspection and copying by the Food method entitled ‘‘Insoluble Impurities’’ and Drug Administration. (AOCS Method Ca 3a–46), American Oil Chemists’ Society (AOCS), 5th Edition, [62 FR 30976, June 5, 1997, as amended at 73 1997, incorporated by reference in ac- FR 22756, Apr. 25, 2008] cordance with 5 U.S.C. 552(a) and 1 CFR EFFECTIVE DATE NOTE: At 62 FR 30976, June part 51, or another method equivalent 5, 1997, § 589.2000 was added. Paragraph in accuracy, precision, and sensitivity (e)(1)(iv) of this section contains information to AOCS Official Method Ca 3a–46. You collection and recordkeeping requirements and will not become effective until approval may obtain copies of the method from has been given by the Office of Management the AOCS (http://www.aocs.org), 2211 W. and Budget. Bradley Ave., Champaign, IL 61821. Copies may be examined at the Food § 589.2001 Cattle materials prohibited and Drug Administration’s Main Li- in animal food or feed to prevent brary, 10903 New Hampshire Ave., Bldg. the transmission of bovine 2, Third Floor, Silver Spring, MD 20993, spongiform encephalopathy. 301–796–2039, or at the National Ar- (a) Purpose—The purpose of this sec- chives and Records Administration tion is to prohibit the use of certain (NARA). For information on the avail- cattle origin materials in the food or ability of this material at NARA, call feed of all animals to further reduce 202–741–6030, or go to: http:// the risk of the spread of bovine www.archives.gov/federallregister/ spongiform encephalopathy (BSE) codeloflfederallregulations/ within the United States. ibrllocations.html.

591

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(C) Materials as defined in para- animal feed as defined in paragraph graphs (b)(1)(ii), (b)(1)(iii), (b)(1)(iv) (b)(1) of this section. (other than mechanically separated (2) Renderers that receive, manufac- beef from the carcass of a BSE-positive ture, process, blend, or distribute cat- cattle), and (b)(1)(v) of this section tle materials prohibited in animal feed from cattle from a country that has as defined in paragraph (b)(1) of this been designated under paragraph (f) of section, or products that contain or this section. may contain cattle materials prohib- (2) Cattle not inspected and passed for ited in animal feed, shall take the fol- human consumption means cattle that lowing measures to ensure that mate- did not pass antemortem inspection by rials prohibited as defined in paragraph the appropriate regulatory authority. (b)(1) of this section are not introduced This term includes nonambulatory dis- into animal feed: abled cattle. Nonambulatory disabled (i) Exclude from use in animal feed cattle are cattle that cannot rise from the entire carcass of cattle not in- a recumbent position or that cannot spected and passed for human con- walk, including, but not limited to, sumption as defined in paragraph (b)(2) those with broken appendages, severed of this section if: tendons or ligaments, nerve paralysis, (A) The brain and spinal cord are not fractured vertebral column, or meta- effectively removed from such cattle or bolic conditions. the brain and spinal cord from such (3) Mechanically separated beef means cattle are not otherwise effectively ex- a finely comminuted meat food prod- cluded from animal feed; and uct, resulting from the mechanical sep- (B) Such cattle are 30 months of age aration and removal of most of the or older. bone from attached skeletal muscle of (ii) If renderers remove brain and spi- cattle carcasses and parts of carcasses. nal cord from cattle not inspected and passed for human consumption, or sep- (4) Renderer means any firm or indi- arate such animals based on whether or vidual that processes slaughter byprod- not they are 30 months of age or older, ucts, animals unfit for human con- renderers must maintain adequate sumption, or meat scraps. The term in- written procedures specifying how cludes persons who collect such mate- these processes are carried out. rials and subject them to minimal (iii) Once cattle materials prohibited processing, or distribute them to firms in animal feed have been separated other than renderers (as defined in this from other cattle materials, provide paragraph) whose intended use for the for measures to avoid cross-contamina- products may include animal feed, in- tion; dustrial use, or other uses. The term (A) Use separate equipment while includes renderers that also blend ani- handling cattle materials prohibited in mal protein products. animal feed; or (5) Tallow means the rendered fat of (B) Use separate containers that ade- cattle obtained by pressing or by ap- quately prevent contact with animal plying any other extraction process to feed, animal feed ingredients, or equip- tissues derived directly from discrete ment surfaces; adipose tissue masses or to other car- (iv) Label the cattle materials pro- cass parts and tissues. hibited in animal feed and products (6) Tallow derivative means any prod- that contain or may contain cattle ma- uct obtained through initial hydrol- terials prohibited in animal feed in a ysis, saponification, or trans- conspicuous manner as follows: ‘‘Do esterification of tallow; chemical con- not feed to animals’’; version of material obtained by hydrol- (v) Mark the cattle materials prohib- ysis, saponification, or trans- ited in animal feed and products that esterification may be applied to obtain contain or may contain cattle mate- the desired product. rials prohibited in animal feed with an (c) Requirements. (1) No animal feed or agent that can be readily detected on feed ingredient shall be manufactured visual inspection; and from, processed with, or otherwise con- (vi) Establish and maintain records tain, cattle materials prohibited in sufficient to track cattle materials

592

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prohibited in animal feed to ensure (c)(2)(vi), or (c)(3)(i) of this section will such material is not introduced into render the animal feed or feed ingredi- animal feed, and make the records ents adulterated under section 402(a)(4) available for inspection and copying by of the Federal Food, Drug, and Cos- the Food and Drug Administration. metic Act (the act). (3) Renderers that receive, manufac- (2) Animal feed or feed ingredients ture, process, blend, or distribute any that are not in compliance with para- cattle materials shall take the fol- graph (c)(1) of this section are adulter- lowing measures to ensure that mate- ated under section 402(a)(2), 402(a)(3), or rials prohibited as defined in paragraph 402(a)(5) of the act. (b)(1) of this section are not used in (3) Animal feed or feed ingredients animal feed: (i) Establish and maintain records that are not in compliance with the la- sufficient to demonstrate that material beling requirements of paragraph rendered for use in animal feed was not (c)(2)(iv) of this section are misbranded manufactured from, processed with, or under section 403(a)(1) or 403(f) of the does not otherwise contain, cattle ma- act. terials prohibited in animal feed and (4) Failure of a renderer to comply make copies of all records available for with the requirements in paragraph (e) inspection and copying by the Food of this section will render the animal and Drug Administration. With respect feed or feed ingredients adulterated to cattle materials obtained from es- under section 402(a)(4) of the act. tablishments which have segregated (e) Inspection; records retention. cattle materials prohibited in animal Records required to be made available feed, such records must demonstrate for inspection and copying by the Food that establishments supplying cattle and Drug Administration, as required materials to the renderers have ade- by this section, shall be kept for a min- quate procedures in place to effectively imum of 1 year. exclude cattle materials prohibited in (f) Process for designating countries. A animal feed; and these records shall be country seeking designation must send considered sufficient to meet this re- a written request to the Director, Of- quirement if they include either: fice of the Center Director, Center for (A) Certification or other documentation from the supplier that material Veterinary Medicine, at the address supplied to the renderer does not in- designated in § 5.1100 of this chapter. clude cattle materials prohibited in The request shall include information animal feed; such certification or docu- about that country’s BSE case history, mentation is acceptable, provided that risk factors, measures to prevent the it includes a description of the segrega- introduction and transmission of BSE, tion procedures used, documentation and any other information relevant to that the supplier confirms that its seg- determining whether the cattle mate- regation procedures are in place prior rials from the requesting country do or to supplying any cattle material to the do not meet the definitions set forth in renderer, and records of the renderer’s paragraph (b)(1) of this section. FDA periodic review of the suppliers’ certifi- shall respond in writing to any such re- cation or other documentation; or quest and may impose conditions in (B) Documentation of another meth- granting any such request. Any grant od acceptable to FDA, such as third- by FDA of such a request under this party certification, for verifying that paragraph will be subject to future re- suppliers have effectively excluded cat- view by FDA and may be revoked if tle materials prohibited in animal feed. FDA determines that the granted re- (ii) Comply with all applicable request is no longer appropriate. quirements under § 589.2000 regarding animal proteins prohibited in ruminant [73 FR 22756, Apr. 25, 2008, as amended at 81 feed. FR 5596, Feb. 3, 2016] (d) Adulteration and misbranding. (1) Failure of a renderer to comply with PARTS 590–599 [RESERVED] the requirements in paragraphs (c)(2)(i) through (c)(2)(iii), (c)(2)(v) and

593

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A list of CFR titles, subtitles, chapters, subchapters and parts and an alphabetical list of agencies publishing in the CFR are included in the CFR Index and Finding Aids volume to the Code of Federal Regulations which is published separately and revised annually. Table of CFR Titles and Chapters Alphabetical List of Agencies Appearing in the CFR List of CFR Sections Affected

595

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Title 1—General Provisions

I Administrative Committee of the Federal Register (Parts 1—49) II Office of the Federal Register (Parts 50—299) III Administrative Conference of the United States (Parts 300—399) IV Miscellaneous Agencies (Parts 400—599) VI National Capital Planning Commission (Parts 600—699)

Title 2—Grants and Agreements

SUBTITLE A—OFFICE OF MANAGEMENT AND BUDGET GUIDANCE FOR GRANTS AND AGREEMENTS I Office of Management and Budget Governmentwide Guidance for Grants and Agreements (Parts 2—199) II Office of Management and Budget Guidance (Parts 200—299) SUBTITLE B—FEDERAL AGENCY REGULATIONS FOR GRANTS AND AGREEMENTS III Department of Health and Human Services (Parts 300—399) IV Department of Agriculture (Parts 400—499) VI Department of State (Parts 600—699) VII Agency for International Development (Parts 700—799) VIII Department of Veterans Affairs (Parts 800—899) IX Department of Energy (Parts 900—999) X Department of the Treasury (Parts 1000—1099) XI Department of Defense (Parts 1100—1199) XII Department of Transportation (Parts 1200—1299) XIII Department of Commerce (Parts 1300—1399) XIV Department of the Interior (Parts 1400—1499) XV Environmental Protection Agency (Parts 1500—1599) XVIII National Aeronautics and Space Administration (Parts 1800— 1899) XX United States Nuclear Regulatory Commission (Parts 2000—2099) XXII Corporation for National and Community Service (Parts 2200— 2299) XXIII Social Security Administration (Parts 2300—2399) XXIV Department of Housing and Urban Development (Parts 2400— 2499) XXV National Science Foundation (Parts 2500—2599) XXVI National Archives and Records Administration (Parts 2600—2699)

597

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XXVII Small Business Administration (Parts 2700—2799) XXVIII Department of Justice (Parts 2800—2899) XXIX Department of Labor (Parts 2900—2999) XXX Department of Homeland Security (Parts 3000—3099) XXXI Institute of Museum and Library Services (Parts 3100—3199) XXXII National Endowment for the Arts (Parts 3200—3299) XXXIII National Endowment for the Humanities (Parts 3300—3399) XXXIV Department of Education (Parts 3400—3499) XXXV Export-Import Bank of the United States (Parts 3500—3599) XXXVI Office of National Drug Control Policy, Executive Office of the President (Parts 3600—3699) XXXVII Peace Corps (Parts 3700—3799) LVIII Election Assistance Commission (Parts 5800—5899) LIX Gulf Coast Ecosystem Restoration Council (Parts 5900—5999)

Title 3—The President

I Executive Office of the President (Parts 100—199)

Title 4—Accounts

I Government Accountability Office (Parts 1—199)

Title 5—Administrative Personnel

I Office of Personnel Management (Parts 1—1199) II Merit Systems Protection Board (Parts 1200—1299) III Office of Management and Budget (Parts 1300—1399) IV Office of Personnel Management and Office of the Director of National Intelligence (Parts 1400—1499) V The International Organizations Employees Loyalty Board (Parts 1500—1599) VI Federal Retirement Thrift Investment Board (Parts 1600—1699) VIII Office of Special Counsel (Parts 1800—1899) IX Appalachian Regional Commission (Parts 1900—1999) XI Armed Forces Retirement Home (Parts 2100—2199) XIV Federal Labor Relations Authority, General Counsel of the Fed- eral Labor Relations Authority and Federal Service Impasses Panel (Parts 2400—2499) XVI Office of Government Ethics (Parts 2600—2699) XXI Department of the Treasury (Parts 3100—3199) XXII Federal Deposit Insurance Corporation (Parts 3200—3299) XXIII Department of Energy (Parts 3300—3399) XXIV Federal Energy Regulatory Commission (Parts 3400—3499) XXV Department of the Interior (Parts 3500—3599) XXVI Department of Defense (Parts 3600—3699)

598

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XXVIII Department of Justice (Parts 3800—3899) XXIX Federal Communications Commission (Parts 3900—3999) XXX Farm Credit System Insurance Corporation (Parts 4000—4099) XXXI Farm Credit Administration (Parts 4100—4199) XXXIII Overseas Private Investment Corporation (Parts 4300—4399) XXXIV Securities and Exchange Commission (Parts 4400—4499) XXXV Office of Personnel Management (Parts 4500—4599) XXXVI Department of Homeland Security (Parts 4600—4699) XXXVII Federal Election Commission (Parts 4700—4799) XL Interstate Commerce Commission (Parts 5000—5099) XLI Commodity Futures Trading Commission (Parts 5100—5199) XLII Department of Labor (Parts 5200—5299) XLIII National Science Foundation (Parts 5300—5399) XLV Department of Health and Human Services (Parts 5500—5599) XLVI Postal Rate Commission (Parts 5600—5699) XLVII Federal Trade Commission (Parts 5700—5799) XLVIII Nuclear Regulatory Commission (Parts 5800—5899) XLIX Federal Labor Relations Authority (Parts 5900—5999) L Department of Transportation (Parts 6000—6099) LII Export-Import Bank of the United States (Parts 6200—6299) LIII Department of Education (Parts 6300—6399) LIV Environmental Protection Agency (Parts 6400—6499) LV National Endowment for the Arts (Parts 6500—6599) LVI National Endowment for the Humanities (Parts 6600—6699) LVII General Services Administration (Parts 6700—6799) LVIII Board of Governors of the Federal Reserve System (Parts 6800— 6899) LIX National Aeronautics and Space Administration (Parts 6900— 6999) LX United States Postal Service (Parts 7000—7099) LXI National Labor Relations Board (Parts 7100—7199) LXII Equal Employment Opportunity Commission (Parts 7200—7299) LXIII Inter-American Foundation (Parts 7300—7399) LXIV Merit Systems Protection Board (Parts 7400—7499) LXV Department of Housing and Urban Development (Parts 7500— 7599) LXVI National Archives and Records Administration (Parts 7600—7699) LXVII Institute of Museum and Library Services (Parts 7700—7799) LXVIII Commission on Civil Rights (Parts 7800—7899) LXIX Tennessee Valley Authority (Parts 7900—7999) LXX Court Services and Offender Supervision Agency for the District of Columbia (Parts 8000—8099) LXXI Consumer Product Safety Commission (Parts 8100—8199) LXXIII Department of Agriculture (Parts 8300—8399)

599

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LXXIV Federal Mine Safety and Health Review Commission (Parts 8400—8499) LXXVI Federal Retirement Thrift Investment Board (Parts 8600—8699) LXXVII Office of Management and Budget (Parts 8700—8799) LXXX Federal Housing Finance Agency (Parts 9000—9099) LXXXIII Special Inspector General for Afghanistan Reconstruction (Parts 9300—9399) LXXXIV Bureau of Consumer Financial Protection (Parts 9400—9499) LXXXVI National Credit Union Administration (Parts 9600—9699) XCVII Department of Homeland Security Human Resources Manage- ment System (Department of Homeland Security—Office of Personnel Management) (Parts 9700—9799) XCVIII Council of the Inspectors General on Integrity and Efficiency (Parts 9800—9899) XCIX Military Compensation and Retirement Modernization Commis- sion (Parts 9900—9999) C National Council on Disability (Parts 10000—10049)

Title 6—Domestic Security

I Department of Homeland Security, Office of the Secretary (Parts 1—199) X Privacy and Civil Liberties Oversight Board (Parts 1000—1099)

Title 7—Agriculture

SUBTITLE A—OFFICE OF THE SECRETARY OF AGRICULTURE (PARTS 0—26) SUBTITLE B—REGULATIONS OF THE DEPARTMENT OF AGRICULTURE I Agricultural Marketing Service (Standards, Inspections, Mar- keting Practices), Department of Agriculture (Parts 27—209) II Food and Nutrition Service, Department of Agriculture (Parts 210—299) III Animal and Plant Health Inspection Service, Department of Ag- riculture (Parts 300—399) IV Federal Crop Insurance Corporation, Department of Agriculture (Parts 400—499) V Agricultural Research Service, Department of Agriculture (Parts 500—599) VI Natural Resources Conservation Service, Department of Agri- culture (Parts 600—699) VII Farm Service Agency, Department of Agriculture (Parts 700— 799) VIII Grain Inspection, Packers and Stockyards Administration (Fed- eral Grain Inspection Service), Department of Agriculture (Parts 800—899) IX Agricultural Marketing Service (Marketing Agreements and Or- ders; Fruits, Vegetables, Nuts), Department of Agriculture (Parts 900—999)

600

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X Agricultural Marketing Service (Marketing Agreements and Or- ders; Milk), Department of Agriculture (Parts 1000—1199) XI Agricultural Marketing Service (Marketing Agreements and Or- ders; Miscellaneous Commodities), Department of Agriculture (Parts 1200—1299) XIV Commodity Credit Corporation, Department of Agriculture (Parts 1400—1499) XV Foreign Agricultural Service, Department of Agriculture (Parts 1500—1599) XVI Rural Telephone Bank, Department of Agriculture (Parts 1600— 1699) XVII Rural Utilities Service, Department of Agriculture (Parts 1700— 1799) XVIII Rural Housing Service, Rural Business-Cooperative Service, Rural Utilities Service, and Farm Service Agency, Depart- ment of Agriculture (Parts 1800—2099) XX Local Television Loan Guarantee Board (Parts 2200—2299) XXV Office of Advocacy and Outreach, Department of Agriculture (Parts 2500—2599) XXVI Office of Inspector General, Department of Agriculture (Parts 2600—2699) XXVII Office of Information Resources Management, Department of Agriculture (Parts 2700—2799) XXVIII Office of Operations, Department of Agriculture (Parts 2800— 2899) XXIX Office of Energy Policy and New Uses, Department of Agri- culture (Parts 2900—2999) XXX Office of the Chief Financial Officer, Department of Agriculture (Parts 3000—3099) XXXI Office of Environmental Quality, Department of Agriculture (Parts 3100—3199) XXXII Office of Procurement and Property Management, Department of Agriculture (Parts 3200—3299) XXXIII Office of Transportation, Department of Agriculture (Parts 3300—3399) XXXIV National Institute of Food and Agriculture (Parts 3400—3499) XXXV Rural Housing Service, Department of Agriculture (Parts 3500— 3599) XXXVI National Agricultural Statistics Service, Department of Agri- culture (Parts 3600—3699) XXXVII Economic Research Service, Department of Agriculture (Parts 3700—3799) XXXVIII World Agricultural Outlook Board, Department of Agriculture (Parts 3800—3899) XLI [Reserved] XLII Rural Business-Cooperative Service and Rural Utilities Service, Department of Agriculture (Parts 4200—4299)

601

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I Department of Homeland Security (Immigration and Naturaliza- tion) (Parts 1—499) V Executive Office for Immigration Review, Department of Justice (Parts 1000—1399)

Title 9—Animals and Animal Products

I Animal and Plant Health Inspection Service, Department of Ag- riculture (Parts 1—199) II Grain Inspection, Packers and Stockyards Administration (Packers and Stockyards Programs), Department of Agri- culture (Parts 200—299) III Food Safety and Inspection Service, Department of Agriculture (Parts 300—599)

Title 10—Energy

I Nuclear Regulatory Commission (Parts 0—199) II Department of Energy (Parts 200—699) III Department of Energy (Parts 700—999) X Department of Energy (General Provisions) (Parts 1000—1099) XIII Nuclear Waste Technical Review Board (Parts 1300—1399) XVII Defense Nuclear Facilities Safety Board (Parts 1700—1799) XVIII Northeast Interstate Low-Level Radioactive Waste Commission (Parts 1800—1899)

Title 11—Federal Elections

I Federal Election Commission (Parts 1—9099) II Election Assistance Commission (Parts 9400—9499)

Title 12—Banks and Banking

I Comptroller of the Currency, Department of the Treasury (Parts 1—199) II Federal Reserve System (Parts 200—299) III Federal Deposit Insurance Corporation (Parts 300—399) IV Export-Import Bank of the United States (Parts 400—499) V Office of Thrift Supervision, Department of the Treasury (Parts 500—599) VI Farm Credit Administration (Parts 600—699) VII National Credit Union Administration (Parts 700—799) VIII Federal Financing Bank (Parts 800—899) IX Federal Housing Finance Board (Parts 900—999) X Bureau of Consumer Financial Protection (Parts 1000—1099) XI Federal Financial Institutions Examination Council (Parts 1100—1199) XII Federal Housing Finance Agency (Parts 1200—1299)

602

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XIII Financial Stability Oversight Council (Parts 1300—1399) XIV Farm Credit System Insurance Corporation (Parts 1400—1499) XV Department of the Treasury (Parts 1500—1599) XVI Office of Financial Research (Parts 1600—1699) XVII Office of Federal Housing Enterprise Oversight, Department of Housing and Urban Development (Parts 1700—1799) XVIII Community Development Financial Institutions Fund, Depart- ment of the Treasury (Parts 1800—1899)

Title 13—Business Credit and Assistance

I Small Business Administration (Parts 1—199) III Economic Development Administration, Department of Com- merce (Parts 300—399) IV Emergency Steel Guarantee Loan Board (Parts 400—499) V Emergency Oil and Gas Guaranteed Loan Board (Parts 500—599)

Title 14—Aeronautics and Space

I Federal Aviation Administration, Department of Transportation (Parts 1—199) II Office of the Secretary, Department of Transportation (Aviation Proceedings) (Parts 200—399) III Commercial Space Transportation, Federal Aviation Adminis- tration, Department of Transportation (Parts 400—1199) V National Aeronautics and Space Administration (Parts 1200— 1299) VI Air Transportation System Stabilization (Parts 1300—1399)

Title 15—Commerce and Foreign Trade

SUBTITLE A—OFFICE OF THE SECRETARY OF COMMERCE (PARTS 0— 29) SUBTITLE B—REGULATIONS RELATING TO COMMERCE AND FOREIGN TRADE I Bureau of the Census, Department of Commerce (Parts 30—199) II National Institute of Standards and Technology, Department of Commerce (Parts 200—299) III International Trade Administration, Department of Commerce (Parts 300—399) IV Foreign-Trade Zones Board, Department of Commerce (Parts 400—499) VII Bureau of Industry and Security, Department of Commerce (Parts 700—799) VIII Bureau of Economic Analysis, Department of Commerce (Parts 800—899) IX National Oceanic and Atmospheric Administration, Department of Commerce (Parts 900—999)

603

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XI National Technical Information Service, Department of Com- merce (Parts 1100—1199) XIII East-West Foreign Trade Board (Parts 1300—1399) XIV Minority Business Development Agency (Parts 1400—1499) SUBTITLE C—REGULATIONS RELATING TO FOREIGN TRADE AGREE- MENTS XX Office of the United States Trade Representative (Parts 2000— 2099) SUBTITLE D—REGULATIONS RELATING TO TELECOMMUNICATIONS AND INFORMATION XXIII National Telecommunications and Information Administration, Department of Commerce (Parts 2300—2399) [Reserved]

Title 16—Commercial Practices

I Federal Trade Commission (Parts 0—999) II Consumer Product Safety Commission (Parts 1000—1799)

Title 17—Commodity and Securities Exchanges

I Commodity Futures Trading Commission (Parts 1—199) II Securities and Exchange Commission (Parts 200—399) IV Department of the Treasury (Parts 400—499)

Title 18—Conservation of Power and Water Resources

I Federal Energy Regulatory Commission, Department of Energy (Parts 1—399) III Delaware River Basin Commission (Parts 400—499) VI Water Resources Council (Parts 700—799) VIII Susquehanna River Basin Commission (Parts 800—899) XIII Tennessee Valley Authority (Parts 1300—1399)

Title 19—Customs Duties

I U.S. Customs and Border Protection, Department of Homeland Security; Department of the Treasury (Parts 0—199) II United States International Trade Commission (Parts 200—299) III International Trade Administration, Department of Commerce (Parts 300—399) IV U.S. Immigration and Customs Enforcement, Department of Homeland Security (Parts 400—599) [Reserved]

Title 20—Employees’ Benefits

I Office of Workers’ Compensation Programs, Department of Labor (Parts 1—199) II Railroad Retirement Board (Parts 200—399)

604

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III Social Security Administration (Parts 400—499) IV Employees’ Compensation Appeals Board, Department of Labor (Parts 500—599) V Employment and Training Administration, Department of Labor (Parts 600—699) VI Office of Workers’ Compensation Programs, Department of Labor (Parts 700—799) VII Benefits Review Board, Department of Labor (Parts 800—899) VIII Joint Board for the Enrollment of Actuaries (Parts 900—999) IX Office of the Assistant Secretary for Veterans’ Employment and Training Service, Department of Labor (Parts 1000—1099)

Title 21—Food and Drugs

I Food and Drug Administration, Department of Health and Human Services (Parts 1—1299) II Drug Enforcement Administration, Department of Justice (Parts 1300—1399) III Office of National Drug Control Policy (Parts 1400—1499)

Title 22—Foreign Relations

I Department of State (Parts 1—199) II Agency for International Development (Parts 200—299) III Peace Corps (Parts 300—399) IV International Joint Commission, United States and Canada (Parts 400—499) V Broadcasting Board of Governors (Parts 500—599) VII Overseas Private Investment Corporation (Parts 700—799) IX Foreign Service Grievance Board (Parts 900—999) X Inter-American Foundation (Parts 1000—1099) XI International Boundary and Water Commission, United States and Mexico, United States Section (Parts 1100—1199) XII United States International Development Cooperation Agency (Parts 1200—1299) XIII Millennium Challenge Corporation (Parts 1300—1399) XIV Foreign Service Labor Relations Board; Federal Labor Relations Authority; General Counsel of the Federal Labor Relations Authority; and the Foreign Service Impasse Disputes Panel (Parts 1400—1499) XV African Development Foundation (Parts 1500—1599) XVI Japan-United States Friendship Commission (Parts 1600—1699) XVII United States Institute of Peace (Parts 1700—1799)

Title 23—Highways

I Federal Highway Administration, Department of Transportation (Parts 1—999)

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II National Highway Traffic Safety Administration and Federal Highway Administration, Department of Transportation (Parts 1200—1299) III National Highway Traffic Safety Administration, Department of Transportation (Parts 1300—1399)

Title 24—Housing and Urban Development

SUBTITLE A—OFFICE OF THE SECRETARY, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (PARTS 0—99) SUBTITLE B—REGULATIONS RELATING TO HOUSING AND URBAN DE- VELOPMENT I Office of Assistant Secretary for Equal Opportunity, Department of Housing and Urban Development (Parts 100—199) II Office of Assistant Secretary for Housing-Federal Housing Com- missioner, Department of Housing and Urban Development (Parts 200—299) III Government National Mortgage Association, Department of Housing and Urban Development (Parts 300—399) IV Office of Housing and Office of Multifamily Housing Assistance Restructuring, Department of Housing and Urban Develop- ment (Parts 400—499) V Office of Assistant Secretary for Community Planning and De- velopment, Department of Housing and Urban Development (Parts 500—599) VI Office of Assistant Secretary for Community Planning and De- velopment, Department of Housing and Urban Development (Parts 600—699) [Reserved] VII Office of the Secretary, Department of Housing and Urban Devel- opment (Housing Assistance Programs and Public and Indian Housing Programs) (Parts 700—799) VIII Office of the Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Develop- ment (Section 8 Housing Assistance Programs, Section 202 Di- rect Loan Program, Section 202 Supportive Housing for the El- derly Program and Section 811 Supportive Housing for Persons With Disabilities Program) (Parts 800—899) IX Office of Assistant Secretary for Public and Indian Housing, De- partment of Housing and Urban Development (Parts 900—1699) X Office of Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Develop- ment (Interstate Land Sales Registration Program) (Parts 1700—1799) XII Office of Inspector General, Department of Housing and Urban Development (Parts 2000—2099) XV Emergency Mortgage Insurance and Loan Programs, Depart- ment of Housing and Urban Development (Parts 2700—2799) [Reserved] XX Office of Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Develop- ment (Parts 3200—3899)

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XXIV Board of Directors of the HOPE for Homeowners Program (Parts 4000—4099) [Reserved] XXV Neighborhood Reinvestment Corporation (Parts 4100—4199)

Title 25—Indians

I Bureau of Indian Affairs, Department of the Interior (Parts 1— 299) II Indian Arts and Crafts Board, Department of the Interior (Parts 300—399) III National Indian Gaming Commission, Department of the Inte- rior (Parts 500—599) IV Office of Navajo and Hopi Indian Relocation (Parts 700—899) V Bureau of Indian Affairs, Department of the Interior, and Indian Health Service, Department of Health and Human Services (Parts 900—999) VI Office of the Assistant Secretary, Indian Affairs, Department of the Interior (Parts 1000—1199) VII Office of the Special Trustee for American Indians, Department of the Interior (Parts 1200—1299)

Title 26—Internal Revenue

I Internal Revenue Service, Department of the Treasury (Parts 1— End)

Title 27—Alcohol, Tobacco Products and Firearms

I Alcohol and Tobacco Tax and Trade Bureau, Department of the Treasury (Parts 1—399) II Bureau of Alcohol, Tobacco, Firearms, and Explosives, Depart- ment of Justice (Parts 400—699)

Title 28—Judicial Administration

I Department of Justice (Parts 0—299) III Federal Prison Industries, Inc., Department of Justice (Parts 300—399) V Bureau of Prisons, Department of Justice (Parts 500—599) VI Offices of Independent Counsel, Department of Justice (Parts 600—699) VII Office of Independent Counsel (Parts 700—799) VIII Court Services and Offender Supervision Agency for the District of Columbia (Parts 800—899) IX National Crime Prevention and Privacy Compact Council (Parts 900—999) XI Department of Justice and Department of State (Parts 1100— 1199)

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SUBTITLE A—OFFICE OF THE SECRETARY OF LABOR (PARTS 0—99) SUBTITLE B—REGULATIONS RELATING TO LABOR I National Labor Relations Board (Parts 100—199) II Office of Labor-Management Standards, Department of Labor (Parts 200—299) III National Railroad Adjustment Board (Parts 300—399) IV Office of Labor-Management Standards, Department of Labor (Parts 400—499) V Wage and Hour Division, Department of Labor (Parts 500—899) IX Construction Industry Collective Bargaining Commission (Parts 900—999) X National Mediation Board (Parts 1200—1299) XII Federal Mediation and Conciliation Service (Parts 1400—1499) XIV Equal Employment Opportunity Commission (Parts 1600—1699) XVII Occupational Safety and Health Administration, Department of Labor (Parts 1900—1999) XX Occupational Safety and Health Review Commission (Parts 2200—2499) XXV Employee Benefits Security Administration, Department of Labor (Parts 2500—2599) XXVII Federal Mine Safety and Health Review Commission (Parts 2700—2799) XL Pension Benefit Guaranty Corporation (Parts 4000—4999)

Title 30—Mineral Resources

I Mine Safety and Health Administration, Department of Labor (Parts 1—199) II Bureau of Safety and Environmental Enforcement, Department of the Interior (Parts 200—299) IV Geological Survey, Department of the Interior (Parts 400—499) V Bureau of Ocean Energy Management, Department of the Inte- rior (Parts 500—599) VII Office of Surface Mining Reclamation and Enforcement, Depart- ment of the Interior (Parts 700—999) XII Office of Natural Resources Revenue, Department of the Interior (Parts 1200—1299)

Title 31—Money and Finance: Treasury

SUBTITLE A—OFFICE OF THE SECRETARY OF THE TREASURY (PARTS 0—50) SUBTITLE B—REGULATIONS RELATING TO MONEY AND FINANCE I Monetary Offices, Department of the Treasury (Parts 51—199) II Fiscal Service, Department of the Treasury (Parts 200—399) IV Secret Service, Department of the Treasury (Parts 400—499) V Office of Foreign Assets Control, Department of the Treasury (Parts 500—599)

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VI Bureau of Engraving and Printing, Department of the Treasury (Parts 600—699) VII Federal Law Enforcement Training Center, Department of the Treasury (Parts 700—799) VIII Office of Investment Security, Department of the Treasury (Parts 800—899) IX Federal Claims Collection Standards (Department of the Treas- ury—Department of Justice) (Parts 900—999) X Financial Crimes Enforcement Network, Department of the Treasury (Parts 1000—1099)

Title 32—National Defense

SUBTITLE A—DEPARTMENT OF DEFENSE I Office of the Secretary of Defense (Parts 1—399) V Department of the Army (Parts 400—699) VI Department of the Navy (Parts 700—799) VII Department of the Air Force (Parts 800—1099) SUBTITLE B—OTHER REGULATIONS RELATING TO NATIONAL DE- FENSE XII Defense Logistics Agency (Parts 1200—1299) XVI Selective Service System (Parts 1600—1699) XVII Office of the Director of National Intelligence (Parts 1700—1799) XVIII National Counterintelligence Center (Parts 1800—1899) XIX Central Intelligence Agency (Parts 1900—1999) XX Information Security Oversight Office, National Archives and Records Administration (Parts 2000—2099) XXI National Security Council (Parts 2100—2199) XXIV Office of Science and Technology Policy (Parts 2400—2499) XXVII Office for Micronesian Status Negotiations (Parts 2700—2799) XXVIII Office of the Vice President of the United States (Parts 2800— 2899)

Title 33—Navigation and Navigable Waters

I Coast Guard, Department of Homeland Security (Parts 1—199) II Corps of Engineers, Department of the Army, Department of De- fense (Parts 200—399) IV Saint Lawrence Seaway Development Corporation, Department of Transportation (Parts 400—499)

Title 34—Education

SUBTITLE A—OFFICE OF THE SECRETARY, DEPARTMENT OF EDU- CATION (PARTS 1—99) SUBTITLE B—REGULATIONS OF THE OFFICES OF THE DEPARTMENT OF EDUCATION I Office for Civil Rights, Department of Education (Parts 100—199)

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II Office of Elementary and Secondary Education, Department of Education (Parts 200—299) III Office of Special Education and Rehabilitative Services, Depart- ment of Education (Parts 300—399) IV Office of Career, Technical and Adult Education, Department of Education (Parts 400—499) V Office of Bilingual Education and Minority Languages Affairs, Department of Education (Parts 500—599) [Reserved] VI Office of Postsecondary Education, Department of Education (Parts 600—699) VII Office of Educational Research and Improvement, Department of Education (Parts 700—799) [Reserved] SUBTITLE C—REGULATIONS RELATING TO EDUCATION XI (Parts 1100—1199) [Reserved] XII National Council on Disability (Parts 1200—1299)

Title 35 [Reserved]

Title 36—Parks, Forests, and Public Property

I National Park Service, Department of the Interior (Parts 1—199) II Forest Service, Department of Agriculture (Parts 200—299) III Corps of Engineers, Department of the Army (Parts 300—399) IV American Battle Monuments Commission (Parts 400—499) V Smithsonian Institution (Parts 500—599) VI [Reserved] VII Library of Congress (Parts 700—799) VIII Advisory Council on Historic Preservation (Parts 800—899) IX Pennsylvania Avenue Development Corporation (Parts 900—999) X Presidio Trust (Parts 1000—1099) XI Architectural and Transportation Barriers Compliance Board (Parts 1100—1199) XII National Archives and Records Administration (Parts 1200—1299) XV Oklahoma City National Memorial Trust (Parts 1500—1599) XVI Morris K. Udall Scholarship and Excellence in National Environ- mental Policy Foundation (Parts 1600—1699)

Title 37—Patents, Trademarks, and Copyrights

I United States Patent and Trademark Office, Department of Commerce (Parts 1—199) II U.S. Copyright Office, Library of Congress (Parts 200—299) III Copyright Royalty Board, Library of Congress (Parts 300—399) IV National Institute of Standards and Technology, Department of Commerce (Parts 400—599)

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I Department of Veterans Affairs (Parts 0—199) II Armed Forces Retirement Home (Parts 200—299)

Title 39—Postal Service

I United States Postal Service (Parts 1—999) III Postal Regulatory Commission (Parts 3000—3099)

Title 40—Protection of Environment

I Environmental Protection Agency (Parts 1—1099) IV Environmental Protection Agency and Department of Justice (Parts 1400—1499) V Council on Environmental Quality (Parts 1500—1599) VI Chemical Safety and Hazard Investigation Board (Parts 1600— 1699) VII Environmental Protection Agency and Department of Defense; Uniform National Discharge Standards for Vessels of the Armed Forces (Parts 1700—1799) VIII Gulf Coast Ecosystem Restoration Council (Parts 1800—1899)

Title 41—Public Contracts and Property Management

SUBTITLE A—FEDERAL PROCUREMENT REGULATIONS SYSTEM [NOTE] SUBTITLE B—OTHER PROVISIONS RELATING TO PUBLIC CONTRACTS 50 Public Contracts, Department of Labor (Parts 50–1—50–999) 51 Committee for Purchase From People Who Are Blind or Severely Disabled (Parts 51–1—51–99) 60 Office of Federal Contract Compliance Programs, Equal Employ- ment Opportunity, Department of Labor (Parts 60–1—60–999) 61 Office of the Assistant Secretary for Veterans’ Employment and Training Service, Department of Labor (Parts 61–1—61–999) 62—100 [Reserved] SUBTITLE C—FEDERAL PROPERTY MANAGEMENT REGULATIONS SYSTEM 101 Federal Property Management Regulations (Parts 101–1—101–99) 102 Federal Management Regulation (Parts 102–1—102–299) 103—104 [Reserved] 105 General Services Administration (Parts 105–1—105–999) 109 Department of Energy Property Management Regulations (Parts 109–1—109–99) 114 Department of the Interior (Parts 114–1—114–99) 115 Environmental Protection Agency (Parts 115–1—115–99) 128 Department of Justice (Parts 128–1—128–99) 129—200 [Reserved] SUBTITLE D—OTHER PROVISIONS RELATING TO PROPERTY MANAGE- MENT [RESERVED]

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SUBTITLE E—FEDERAL INFORMATION RESOURCES MANAGEMENT REGULATIONS SYSTEM [RESERVED] SUBTITLE F—FEDERAL TRAVEL REGULATION SYSTEM 300 General (Parts 300–1—300–99) 301 Temporary Duty (TDY) Travel Allowances (Parts 301–1—301–99) 302 Relocation Allowances (Parts 302–1—302–99) 303 Payment of Expenses Connected with the Death of Certain Em- ployees (Part 303–1—303–99) 304 Payment of Travel Expenses from a Non-Federal Source (Parts 304–1—304–99)

Title 42—Public Health

I Public Health Service, Department of Health and Human Serv- ices (Parts 1—199) ii—III [Reserved] IV Centers for Medicare & Medicaid Services, Department of Health and Human Services (Parts 400—699) V Office of Inspector General-Health Care, Department of Health and Human Services (Parts 1000—1099)

Title 43—Public Lands: Interior

SUBTITLE A—OFFICE OF THE SECRETARY OF THE INTERIOR (PARTS 1—199) SUBTITLE B—REGULATIONS RELATING TO PUBLIC LANDS I Bureau of Reclamation, Department of the Interior (Parts 400— 999) II Bureau of Land Management, Department of the Interior (Parts 1000—9999) III Utah Reclamation Mitigation and Conservation Commission (Parts 10000—10099)

Title 44—Emergency Management and Assistance

I Federal Emergency Management Agency, Department of Home- land Security (Parts 0—399) IV Department of Commerce and Department of Transportation (Parts 400—499)

Title 45—Public Welfare

SUBTITLE A—DEPARTMENT OF HEALTH AND HUMAN SERVICES (PARTS 1—199) SUBTITLE B—REGULATIONS RELATING TO PUBLIC WELFARE II Office of Family Assistance (Assistance Programs), Administra- tion for Children and Families, Department of Health and Human Services (Parts 200—299)

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III Office of Child Support Enforcement (Child Support Enforce- ment Program), Administration for Children and Families, Department of Health and Human Services (Parts 300—399) IV Office of Refugee Resettlement, Administration for Children and Families, Department of Health and Human Services (Parts 400—499) V Foreign Claims Settlement Commission of the United States, Department of Justice (Parts 500—599) VI National Science Foundation (Parts 600—699) VII Commission on Civil Rights (Parts 700—799) VIII Office of Personnel Management (Parts 800—899) IX Denali Commission (Parts 900—999) X Office of Community Services, Administration for Children and Families, Department of Health and Human Services (Parts 1000—1099) XI National Foundation on the Arts and the Humanities (Parts 1100—1199) XII Corporation for National and Community Service (Parts 1200— 1299) XIII Administration for Children and Families, Department of Health and Human Services (Parts 1300—1399) XVI Legal Services Corporation (Parts 1600—1699) XVII National Commission on Libraries and Information Science (Parts 1700—1799) XVIII Harry S. Truman Scholarship Foundation (Parts 1800—1899) XXI Commission of Fine Arts (Parts 2100—2199) XXIII Arctic Research Commission (Parts 2300—2399) XXIV James Madison Memorial Fellowship Foundation (Parts 2400— 2499) XXV Corporation for National and Community Service (Parts 2500— 2599)

Title 46—Shipping

I Coast Guard, Department of Homeland Security (Parts 1—199) II Maritime Administration, Department of Transportation (Parts 200—399) III Coast Guard (Great Lakes Pilotage), Department of Homeland Security (Parts 400—499) IV Federal Maritime Commission (Parts 500—599)

Title 47—Telecommunication

I Federal Communications Commission (Parts 0—199) II Office of Science and Technology Policy and National Security Council (Parts 200—299) III National Telecommunications and Information Administration, Department of Commerce (Parts 300—399)

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IV National Telecommunications and Information Administration, Department of Commerce, and National Highway Traffic Safe- ty Administration, Department of Transportation (Parts 400— 499) V The First Responder Network Authority (Parts 500—599)

Title 48—Federal Acquisition Regulations System

1 Federal Acquisition Regulation (Parts 1—99) 2 Defense Acquisition Regulations System, Department of Defense (Parts 200—299) 3 Department of Health and Human Services (Parts 300—399) 4 Department of Agriculture (Parts 400—499) 5 General Services Administration (Parts 500—599) 6 Department of State (Parts 600—699) 7 Agency for International Development (Parts 700—799) 8 Department of Veterans Affairs (Parts 800—899) 9 Department of Energy (Parts 900—999) 10 Department of the Treasury (Parts 1000—1099) 12 Department of Transportation (Parts 1200—1299) 13 Department of Commerce (Parts 1300—1399) 14 Department of the Interior (Parts 1400—1499) 15 Environmental Protection Agency (Parts 1500—1599) 16 Office of Personnel Management, Federal Employees Health Benefits Acquisition Regulation (Parts 1600—1699) 17 Office of Personnel Management (Parts 1700—1799) 18 National Aeronautics and Space Administration (Parts 1800— 1899) 19 Broadcasting Board of Governors (Parts 1900—1999) 20 Nuclear Regulatory Commission (Parts 2000—2099) 21 Office of Personnel Management, Federal Employees Group Life Insurance Federal Acquisition Regulation (Parts 2100—2199) 23 Social Security Administration (Parts 2300—2399) 24 Department of Housing and Urban Development (Parts 2400— 2499) 25 National Science Foundation (Parts 2500—2599) 28 Department of Justice (Parts 2800—2899) 29 Department of Labor (Parts 2900—2999) 30 Department of Homeland Security, Homeland Security Acquisi- tion Regulation (HSAR) (Parts 3000—3099) 34 Department of Education Acquisition Regulation (Parts 3400— 3499) 51 Department of the Army Acquisition Regulations (Parts 5100— 5199) 52 Department of the Navy Acquisition Regulations (Parts 5200— 5299) 53 Department of the Air Force Federal Acquisition Regulation Supplement (Parts 5300—5399) [Reserved]

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54 Defense Logistics Agency, Department of Defense (Parts 5400— 5499) 57 African Development Foundation (Parts 5700—5799) 61 Civilian Board of Contract Appeals, General Services Adminis- tration (Parts 6100—6199) 99 Cost Accounting Standards Board, Office of Federal Procure- ment Policy, Office of Management and Budget (Parts 9900— 9999)

Title 49—Transportation

SUBTITLE A—OFFICE OF THE SECRETARY OF TRANSPORTATION (PARTS 1—99) SUBTITLE B—OTHER REGULATIONS RELATING TO TRANSPORTATION I Pipeline and Hazardous Materials Safety Administration, De- partment of Transportation (Parts 100—199) II Federal Railroad Administration, Department of Transportation (Parts 200—299) III Federal Motor Carrier Safety Administration, Department of Transportation (Parts 300—399) IV Coast Guard, Department of Homeland Security (Parts 400—499) V National Highway Traffic Safety Administration, Department of Transportation (Parts 500—599) VI Federal Transit Administration, Department of Transportation (Parts 600—699) VII National Railroad Passenger Corporation (AMTRAK) (Parts 700—799) VIII National Transportation Safety Board (Parts 800—999) X Surface Transportation Board (Parts 1000—1399) XI Research and Innovative Technology Administration, Depart- ment of Transportation (Parts 1400—1499) [Reserved] XII Transportation Security Administration, Department of Home- land Security (Parts 1500—1699)

Title 50—Wildlife and Fisheries

I United States Fish and Wildlife Service, Department of the Inte- rior (Parts 1—199) II National Marine Fisheries Service, National Oceanic and Atmos- pheric Administration, Department of Commerce (Parts 200— 299) III International Fishing and Related Activities (Parts 300—399) IV Joint Regulations (United States Fish and Wildlife Service, De- partment of the Interior and National Marine Fisheries Serv- ice, National Oceanic and Atmospheric Administration, De- partment of Commerce); Endangered Species Committee Reg- ulations (Parts 400—499) V Marine Mammal Commission (Parts 500—599)

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VI Fishery Conservation and Management, National Oceanic and Atmospheric Administration, Department of Commerce (Parts 600—699)

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CFR Title, Subtitle or Agency Chapter Administrative Committee of the Federal Register 1, I Administrative Conference of the United States 1, III Advisory Council on Historic Preservation 36, VIII Advocacy and Outreach, Office of 7, XXV Afghanistan Reconstruction, Special Inspector General for 5, LXXXIII African Development Foundation 22, XV Federal Acquisition Regulation 48, 57 Agency for International Development 2, VII; 22, II Federal Acquisition Regulation 48, 7 Agricultural Marketing Service 7, I, IX, X, XI Agricultural Research Service 7, V Agriculture Department 2, IV; 5, LXXIII Advocacy and Outreach, Office of 7, XXV Agricultural Marketing Service 7, I, IX, X, XI Agricultural Research Service 7, V Animal and Plant Health Inspection Service 7, III; 9, I Chief Financial Officer, Office of 7, XXX Commodity Credit Corporation 7, XIV Economic Research Service 7, XXXVII Energy Policy and New Uses, Office of 2, IX; 7, XXIX Environmental Quality, Office of 7, XXXI Farm Service Agency 7, VII, XVIII Federal Acquisition Regulation 48, 4 Federal Crop Insurance Corporation 7, IV Food and Nutrition Service 7, II Food Safety and Inspection Service 9, III Foreign Agricultural Service 7, XV Forest Service 36, II Grain Inspection, Packers and Stockyards Administration 7, VIII; 9, II Information Resources Management, Office of 7, XXVII Inspector General, Office of 7, XXVI National Agricultural Library 7, XLI National Agricultural Statistics Service 7, XXXVI National Institute of Food and Agriculture 7, XXXIV Natural Resources Conservation Service 7, VI Operations, Office of 7, XXVIII Procurement and Property Management, Office of 7, XXXII Rural Business-Cooperative Service 7, XVIII, XLII Rural Development Administration 7, XLII Rural Housing Service 7, XVIII, XXXV Rural Telephone Bank 7, XVI Rural Utilities Service 7, XVII, XVIII, XLII Secretary of Agriculture, Office of 7, Subtitle A Transportation, Office of 7, XXXIII World Agricultural Outlook Board 7, XXXVIII Air Force Department 32, VII Federal Acquisition Regulation Supplement 48, 53 Air Transportation Stabilization Board 14, VI Alcohol and Tobacco Tax and Trade Bureau 27, I Alcohol, Tobacco, Firearms, and Explosives, Bureau of 27, II AMTRAK 49, VII American Battle Monuments Commission 36, IV American Indians, Office of the Special Trustee 25, VII

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2013 21 CFR—Continued 78 FR Page 21 CFR 78 FR Chapter I—Continued Page 520.370 (b) amended ...... 5714 Chapter I 520.390a (b)(1)(i) amended...... 21059 500.35 Removed...... 42451 520.441 (b)(3) amended ...... 21059 501 Small entity compliance 520.443 (b) amended ...... 21059 guide ...... 59624 520.446 (b)(1) amended ...... 17596 510.600 (c)(1) table and (2) table 520.447 (b) amended ...... 17596, 30197 amended ...... 5714, 17596, 17867 520.580 Heading, (a), (b), (d)(1) and (c)(1) table amended ...... 14668 (2) revised ...... 14669 (c)(1) table and (2) table amended (b)(2) amended ...... 21059 ... 19987, 21059, 27859, 44433, 52429, 52430, 520.600 (c) amended ...... 21059 52853, 63871, 66264, 73698 520.622a (a)(6) amended ...... 21059 520 Drug application approvals 520.622b (c)(2) amended ...... 21059 withdrawn...... 78716 520.622c (b)(6) amended ...... 21059 520.28 Redesignated from 520.763a (a) and (e) removed; (c) 520.44 ...... 66264 amended...... 21059 520.38 Redesignated from 520.763b (a) removed; (c) amend- 520.45 ...... 66264 ed ...... 21059 520.38a Redesignated from 520.763c (b) amended; (c) re- 520.45a ...... 66264 moved ...... 21059 520.38b Redesignated from 520.812 Revised ...... 30197 520.45b ...... 66264 (a) and (b) revised ...... 52853 520.43 Added ...... 66264 520.955 (b) amended ...... 52854 520.44 Redesignated as 520.28 ...... 66264 520.1010 (b)(3) amended...... 17596 520.45 Redesignated as 520.38 ...... 66264 520.1044b (b) amended...... 17596 520.45a Redesignated as 520.38a...... 66264 520.1192 (b)(2) amended...... 17596 520.45b Redesignated as 520.38b...... 66264 520.1193 (b)(2) amended...... 17596 520.100 (b)(4) and (d)(1) introduc- 520.1195 (b)(1) amended...... 17596 tory text revised...... 23 520.1350 Redesignated as (b)(3) amended...... 17596 520.1367 ...... 57058 (b)(2) revised ...... 57058 520.1367 Redesignated from 520.182 Removed ...... 14669 520.1350; (a) and (b) revised...... 57058 520.260 Heading revised; (b)(1) and 520.1408 (b) amended; (c) re- (3) revised ...... 14669 moved ...... 21060 520.309 (b)(2) amended ...... 52853, 66264 520.1484 (b)(3) amended...... 17596

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21 CFR—Continued 78 FR 21 CFR—Continued 78 FR Page Page Chapter I—Continued Chapter I—Continued 520.1604 Added ...... 42007 (b)(3) and (8) amended ...... 44433 520.1660d (b)(3), (d)(1)(ii)(A)(3), 522.1192 (b)(2) amended...... 17597 (B)(3) and (C)(3) amended ...... 21060 522.1222a (b) amended...... 17597 520.1720a (b)(2) amended...... 17596 (b) amended ...... 21060 (b)(2) amended...... 21060 522.1260 (b)(2) amended...... 17597 520.1870 (b)(2) amended...... 17596 522.1367 (b) amended ...... 5715 520.1900 (b) amended; (c)(1) foot- 522.1410 (b) amended...... 21060 note, (2) footnote and (3) foot- 522.1660a (b) amended...... 17597 note removed...... 21060 522.1662a (i)(2) amended ...... 17597 520.2043 (b)(1) amended...... 17596 (a)(2), (b)(2), (g)(2) and (h)(2) 520.2044 (b)(2) amended...... 17596 amended ...... 21060 520.2087 Removed...... 78716 522.1680 (b) amended...... 17597 520.2088 Removed...... 78716 Heading revised; (b) amended ...... 21060 520.2089 Removed...... 78716 522.1696a (b)(2) amended...... 17597 520.2123c (b) amended...... 17596 522.1696b (b)(1), (d)(2)(i)(A) and 520.2220a (a)(1) amended...... 17596 (iii)(B) amended...... 17597 (a)(1) amended...... 21060 522.1720 (b)(1) amended...... 17597 520.2260b (f)(1) amended ...... 17596 Heading revised; (b)(2) amended 520.2325a (a)(1) amended...... 17596 ...... 21060 520.2345d (b)(2) amended...... 21060 522.1870 Heading, (b), (c)(1)(iii) 520.2612 Revised ...... 63872 and (2)(iii) revised ...... 17868 520.2455 (b)(2) revised; (b)(3) 522.2005 (b)(1) amended...... 17597 added...... 17596 (b)(2) amended...... 17868 522.23 (b)(2) amended...... 17597 522.2120 (b) amended ...... 17597 522.46 Removed...... 14669 522.2220 (a)(2)(iii) amended...... 17597 522.56 (b) amended...... 17597 Heading revised; (c)(2) amended 522.246 (b)(2) and (3) amended...... 17597 ...... 21060 522.313b (b), (d), (e)(2)(i) and (iii) 522.2424 Heading revised; (b) revised ...... 66264 amended; (c)(4) removed ...... 21060 522.390 (b) amended ...... 17597 522.2483 (b) amended...... 21060 522.540 (a)(2)(i), (b)(3)(i), (ii), 522.2615 (b) amended...... 17597 (c)(3)(i), (ii), (d)(2)(i) and (e)(2) 522.2630 (a) and (b) revised ...... 63872 amended...... 17597 522.2662 (b)(1) amended...... 21060 522.558 (a) revised...... 25183 524.916 (b) amended ...... 44433 (a) correctly revised ...... 33699 524.1044g (b)(3) amended...... 17597 522.810 (b) amended ...... 17597 524.1146 (a)(2) and (d)(1)(ii) re- 522.812 (b) and (e)(3)(ii) revised; vised; (d)(3) added ...... 73698 (e)(2) introductory text 524.1193 (b)(2) amended...... 17597 added...... 19987 b)(2) amended...... 63872 522.1010 (b)(3) amended...... 17597 524.1465 (b) amended...... 52854 522.1044 (b)(4) amended...... 17597 524.1580b (b)(1) amended...... 21060 (b)(3) amended...... 21060 524.1580c (b) amended...... 21060 522.1066 (b) amended...... 17597 524.2482 (b) amended...... 17868 522.1073 Added ...... 17867 526.1696b (b) amended...... 21060 522.1075 Redesignated from 529.56 (b) amended...... 17597 522.1078 ...... 17868 529.469 Removed ...... 14669 522.1077 Heading revised; (c)(3) 529.1003 Removed...... 14669 amended...... 17868 529.1044a (b) amended...... 17597 Revised...... 63872 (b) amended ...... 21060 522.1078 Redesignated as 529.1150 (b) amended...... 73698 522.1075 ...... 17868 529.1186 (b) amended...... 14669, 17868 522.1086 (b) amended...... 17597 529.2150 (b) amended...... 17868 522.1145 (e)(2) and (3) heading re- 556.733 (a) amended ...... 52854 vised...... 73698 558.62 (a)(1), (2), (c)(1)(i) and (ii) 522.1182 (b)(1), (6) and (7) amend- removed; (c)(1)(iii), (iv), (v), ed ...... 17597 (vi) and (vii) amended...... 70496

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21 CFR—Continued 78 FR 21 CFR—Continued 79 FR Page Page Chapter I—Continued Chapter I—Continued 558.95 (a), (d)(1), (2), (3), (4)(i) and Regulation at 79 FR 14611 eff. (ii) revised ...... 52430 date confirmed...... 37175 (d)(4)(iii) introductory text and 516.157 (a) revised...... 68115 (iv) introductory text revised; 516.1684 Added ...... 18158 (d)(4)(iii)(d) amended ...... 76060 520 Drug application approvals Technical correction ...... 79299 withdrawn...... 74021 558.120 (a)(1) and (d)(1)(i) re- 520.28 Revised ...... 28816 moved ...... 69993 520.38a (b) amended...... 28816 558.195 (e)(2)(v) table amended ...... 25183 520.38b (b) amended...... 28816 558.205 (a) amended ...... 21060 520.43 (c)(3) revised ...... 37619 558.342 (e)(1)(iv) table and 520.62 Revised ...... 28816 (e)(1)(ix) table amended ...... 25183 520.82 Revised ...... 28816 558.355 (f)(3)(ix) removed; 520.82a Revised ...... 28816 (f)(3)(ii)(b) and (xii)(b) amended ...... 19987 520.82b Revised ...... 28816 (f)(7)(iii)(a) amended ...... 27859 520.88a (a), (b), (c)(1)(i), (iii), (2)(i) (f)(3)(iii) introductory text and (iii) revised...... 28816 amended ...... 66265 520.88b (a), (b), (1)(i)(A), (C), 558.366 (d) table amended ...... 23, 42007, (ii)(A), (C), (c)(1)(i) and (iii) re- 52429 vised...... 28816 558.460 (d)(2)(iv) removed ...... 52430 520.88c (a), (b), (d) heading, (1) and 558.485 (b)(6) amended ...... 14669 (3) revised ...... 28817 (b)(3) amended ...... 52431 520.88d (a), (b), (d) heading, (1) and 558.500 (a), (b), (e)(1) table, (i) (3) revised ...... 28817 table, (2)(i) table, (vi) table and 520.88e (a), (b), (d) heading, (1) and (xi) table amended ...... 63872 (3) revised ...... 28817 558.530 (a) and (b) removed; (d)(1), 520.88f Revised...... 28817 (2) and (3) tables revised ...... 69993 520.88g (b), (c)(1)(i), (iii), (2)(i) and 558.586 (b) amended ...... 17597 (iii) revised ...... 28817 558.618 (b), (e)(1)(i) table, (ii) 520.88h (b), (c)(1)(i), (iii), (2)(i) and table, (2)(i) table, (ii) table and (iii) revised ...... 28817 (iii) table amended...... 19987 520.90a Removed...... 28818 558.625 (b)(35), (63), (66) and (77) re- 520.90b Heading, (b), (c) heading moved ...... 14669 and (3) revised...... 28818 (b)(14) removed...... 52431 520.90c Heading, (b), (c)(1)(iii) and 558.630 (b)(5) added ...... 14669 (2)(iii) revised ...... 28818 558.635 (a)(2) amended ...... 52431 520.90d Heading, (c)(1)(i), (iii), 558.665 (e) table amended...... 42008, 52854 (2)(i) and (iii) revised...... 28818 573.170 Introductory text cor- 520.90e Heading and (d)(3) re- rectly revised ...... 42692 vised...... 28818 579.40 (a) revised ...... 27304 520.90f Heading and (b) revised; (a)(2), (3) and (4) correctly revised (d)(1)(ii) and (2)(ii) amended ...... 28818 ...... 34565 520.110 (d) revised...... 28818 520.154a (b) amended ...... 28818 2014 520.154b (b) amended ...... 28818 21 CFR 79 FR 520.154c (b) amended ...... 28818 Page 520.246 Revised ...... 28818 Chapter I 520.260 Footnote 1 removed; (b)(2) 510 Drug application approvals amended...... 28818 withdrawn ...... 2786, 19816 520.300a (c) revised ...... 28818 510.600 (c)(1) table and (2) table 520.300b (c) revised ...... 28818 amended ...... 2786, 10964, 18157, 19815, 520.300c (c) revised ...... 28819 28816, 37619, 64115, 74019 520.309 (b)(1) amended ...... 28819 514.11 (b), (d), (e) introductory 520.310 (b) amended; footnote 1 re- text and (e)(2)(ii) introductory moved ...... 28819 text revised; eff. 7-30-14 ...... 14611 520.370 (b) amended ...... 28819

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21 CFR—Continued 79 FR 21 CFR—Continued 79 FR Page Page Chapter I—Continued Chapter I—Continued 520.390a (b)(1)(ii) amended; 520.1100 (d)(1)(ii) and (2)(1)(A) re- (b)(1)(iii) removed...... 28819 vised...... 28822 520.390b (b) amended ...... 28819 520.1120a (a) removed; (b) through 520.390c (b) amended ...... 28819 (f) redesignated as new (a) 520.420 Footnote 1 removed ...... 28819 through (e); new (a) and (e) re- 520.434 (b) and (c)(3) amended ...... 28819 vised...... 28822 520.441 (b)(2) amended ...... 28819 520.1120b (a) removed; (b) through 520.446 (b)(1) amended ...... 28819 (e) redesignated as (a) through 520.447 (b) amended ...... 28819 (d); new (d) revised ...... 28822 520.530 (b) and (d)(3) amended ...... 28819 520.1157 Heading and (c)(3) re- 520.531 (a) added; (c) removed; (d) vised...... 28822 redesignated as new (c); (b) and 520.1158 Heading, (b) and (c)(3) renew (c)(3) revised ...... 28819 vised...... 28822 520.534 (a) revised; (b) amended...... 28819 520.1195 (b)(1) and (2) revised...... 10964 520.540a Revised...... 28819 520.1196 Heading, (c)(1)(i) and (iii) 520.540b Footnote 1 removed; revised ...... 28822 (a)(3) and (b)(3) revised ...... 28819 520.1198 (a)(3), (b)(3) and (d)(1)(iii) 520.540c Footnote 1 removed; (b) added; (d)(2) revised ...... 37619 amended; (c) revised ...... 28820 520.1199 (b) amended ...... 28822 520.550 Removed ...... 28820 520.1204 (b) amended ...... 28822 520.563 Heading and (c) revised; 520.1242a (b)(2) amended...... 28822 (b) amended ...... 28820 520.1242b Revised ...... 28822 520.580 (b)(2) amended ...... 28820 520.1242c Revised ...... 28823 520.608 Heading, (b) and (c) re- 520.1242e (b) amended...... 28823 vised...... 28820 520.1242f Heading, (a) and (b) re- 520.622a (a)(2) amended ...... 28820 vised...... 28823 520.622b (a)(2) amended ...... 28820 520.1242g (a) removed; (b) through 520.622c (b)(2) amended ...... 28820 (f) redesignated as new (a) 520.623 Heading, (b) and (c)(3) re- through (e); new (d) revised ...... 28823 vised...... 28820 520.1263a Revised ...... 28823 520.666 (b) amended ...... 28820 520.1263c (b)(1) and (2) amend- 520.763 Revised ...... 28820 ed ...... 28823 520.763a Revised...... 28820 520.1265 (b)(1) amended...... 28823 520.763b Revised...... 28820 520.1284 Revised ...... 28823 520.763c (d) redesignated as (c); 520.1310 Heading revised; (b) (a), (b) and new (c) heading re- amended...... 28823 vised...... 28820 520.1315 (b) amended ...... 28823 520.784 Heading and (c) revised ...... 28821 520.1320 Revised ...... 28823 520.804 Revised ...... 28821 520.1326a (c) heading and (3) re- 520.816 Heading, (b) and (c)(3) revised...... 28824 vised...... 28821 520.1326b (c) heading revised...... 28824 520.823 Heading and (a) revised ...... 28821 520.1330 Revised ...... 28824 520.863 Heading and (c) revised; 520.1331 (b) and (c)(3) revised...... 28824 footnote 1 removed ...... 28821 520.1341 Heading, (b) and (c) re- 520.870 (c) added; (d) removed ...... 28821 vised...... 28824 520.903a Revised...... 28821 520.1380 Revised ...... 28824 520.903b (a), (b) and (c) revised ...... 28821 520.1408 Revised ...... 28824 520.903d Heading and (c)(3) re- 520.1409 (c) and (d) removed; (e) revised; (c)(4) removed ...... 28821 designated as new (c); heading, 520.903e (b) and (c)(3) revised ...... 28821 (b) and new (c) revised ...... 28824 520.960 Heading, (b) and (c)(3) re- 520.1422 (b) amended ...... 28824 vised...... 28821 520.1430 Heading, (b) and (c) re- 520.970 (b) and (c)(1) revised ...... 74020 vised...... 28824 520.980 (b) amended ...... 74020 520.1450a (b) amended...... 28825 520.998 Added ...... 37619 520.1450b (b) amended...... 28825 520.1060 Added ...... 28821 520.1450c (b) amended...... 28825

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21 CFR—Continued 79 FR 21 CFR—Continued 79 FR Page Page Chapter I—Continued Chapter I—Continued 520.1451 (c) removed; (d) redesig- 520.1855 (c)(3) revised ...... 28827 nated as new (c); (b) and new 520.1860 (c) removed; (d) redesig- (c)(3) amended ...... 28825 nated as new (c); (c)(3) 520.1452 (b) amended; (d)(3) re- added...... 28827 vised...... 28825 520.1880 (c) removed; (d) redesig- 520.1453 (b) amended; (d)(3) re- nated as new (c); heading, new vised...... 28825 (c) heading, (1) and (2) re- 520.1468 Revised ...... 28825 vised...... 28827 520.1484 (b)(1), (2) and (3) amend- 520.1900 Heading, (b) and (c)(3) reed ...... 28825 vised...... 28827 520.1628 (b) amended...... 28825 520.1920 Revised ...... 28827 520.1629 (a)(2) and (b)(2) amend- 520.1921 Heading, (b), (c) heading, ed ...... 28825 (2) and (3) revised ...... 28827 520.1630 (b) revised ...... 28825 520.1962 Revised ...... 28827 520.1631 (b) amended...... 28825 520.2002 Revised ...... 28827 520.1638 Revised ...... 28825 520.2043 (b)(1) and (2) amended ...... 28827 520.1640 Removed...... 28825 520.2044 (b)(1) amended...... 28827 520.1660a (b) amended...... 28825 520.2045 Revised ...... 28827 520.1660b (b) and (c) amended ...... 28825 520.2046 Added ...... 28828 520.1660c (b) and (d)(3) amend- 520.2075 (c)(2) amended...... 10964 ed ...... 28825 520.2098 Revised ...... 28828 520.1660d (b)(1), (2), (d)(1)(ii)(A)(3), 520.2100 Revised ...... 28828 (B)(3), (C)(3) and (iii)(C) amend- 520.2123a (a) and (b) revised ...... 28828 ed ...... 28825 520.2123c (b) amended...... 28828 (b)(8) removed; (d)(1)(ii)(A)(3), 520.2150 Revised ...... 28828 (B)(3), (C)(3) and (iii)(C) amend- 520.2150a Removed...... 28828 ed...... 74020 520.2150b Removed...... 28828 520.2158 Removed; redesignated 520.1696b (b) amended...... 28825 from 520.2158a; heading and (a) 520.1696c (c) removed; (d) redesig- revised ...... 28828 nated as new (c); new (c) head- (b) amended ...... 74020 ing and (3) revised ...... 28826 520.2158a Redesignated as 520.1696d (c) removed; (d) redesig- 520.2158 ...... 28828 nated as new (c); (b) and new (c) 520.2158b Removed...... 28828 heading and (3) revised ...... 28826 520.2158c Removed ...... 28828 520.1720a (b)(3) amended...... 28826 520.2160 Removed...... 28828 520.1720b Revised ...... 28826 520.2170 (d) removed; (b), (c) and 520.1720c (c)(3) revised...... 28826 (e) redesignated as new (c), (b) (b)(2) amended ...... 74020 and (d); heading, new (d) head- 520.1720d (c) removed; (d) redesig- ing, (1) and (3) revised ...... 28829 nated as new (c); new (c)(3) re- 520.2184 Revised ...... 28829 vised...... 28826 520.2200 (d)(3)(iii) revised ...... 28829 520.1780 (a) amended ...... 18158 520.2218 (b) amended ...... 28829 520.1802a (b) amended; (c) foot- 520.2220 (a)(1), (2) and (3)(iii) re- note 1 removed; (c) heading, (1) vised...... 10964 and (3) revised...... 28826 520.2220a Revised ...... 28829 520.1802b (b) amended; (c) heading 520.2220b Revised ...... 28829 revised; (c) footnote 1 re- 520.2220c Revised ...... 28829 moved ...... 28826 520.2220d Revised ...... 28829 520.1802c (b) amended; (c) head- 520.2220e Added...... 28830 ing, (1) and (3) revised ...... 28826 520.2220f Added ...... 28830 520.1803 (a) and (c) revised ...... 28826 520.2240a Revised ...... 28830 520.1804 (b) amended; (c) footnote 520.2240b Revised ...... 28830 1 removed ...... 28826 520.2260a (b)(1) amended...... 28830 520.1805 (c)(3) revised ...... 28826 520.2260b (b)(1) and (c)(2)(iii) 520.1807 (b) amended ...... 28827 amended; (c)(2) footnote 1 re- 520.1840 (b)(1) amended...... 28827 moved ...... 28830

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21 CFR—Continued 79 FR 21 CFR—Continued 79 FR Page Page Chapter I—Continued Chapter I—Continued 520.2260c (a) and (b) redesignated 520.2520a Redesignated from as new (b) and (d); new (a) and 520.2520b and revised ...... 28832 (c) added; new (b) and (d)(3) re- 520.2520b Redesignated as vised...... 28830 520.2520a ...... 28832 520.2261a (d) removed; (a), (b) and Redesignated from 520.2520e; (c) (c) redesignated as (b), (c) and and (d) removed; (e) redesig- new (d); new (a) added; new (b) nated as new (c); (b) and new (c) and (c) revised; new (d)(2)(iii) heading and (3) revised ...... 28833 amended...... 28831 520.2520c Redesignated from 520.2261b (d)(1)(ii) revised; 520.2520f; (c) and (d) removed; (d)(4)(iii) amended ...... 28831 (e) redesignated as new (c); (b) 520.2280 Heading, (b) and (c) and new (c) heading and (3) re- amended...... 28831 vised...... 28833 520.2325a Heading revised; (a)(3) 520.2520d Redesignated from amended...... 28831 520.2520g; (c) and (d) removed; 520.2325b Revised ...... 28831 (e) redesignated as new (c); (b), 520.2330 (b) amended; (c) footnote (c) heading and (3) revised ...... 28833 1 removed ...... 28831 520.2520e Redesignated as new 520.2345a Heading and (b) re- 520.2520b ...... 28833 520.2520f Redesignated as vised...... 28831 520.2520c ...... 28833 520.2345b (b) revised ...... 28831 520.2520g Redesignated as 520.2345c (b) revised...... 28831 520.2520d ...... 28833 520.2345d (b)(1), (3), (d)(1)(iii) and 520.2582 Revised ...... 28833 (2)(iii) amended; (b)(5) 520.2604 Revised ...... 28833 added...... 28831 520.2605 Revised ...... 28833 520.2345e Heading and (b) revised; 520.2610 Revised ...... 28833 (c)(1)(iv) removed ...... 28831 520.2611 (b)(1) amended...... 28834 520.2345f (b) amended; (c) heading 520.2613 (a), (b), (c) heading, (1) and (3) revised...... 28831 and (3) revised...... 28834 520.2345g (b) amended; (c) heading (b) amended ...... 64116 and (3) revised...... 28831 520.2640 (d) redesignated as (e); 520.2345h (b) amended; (c) heading new (d) added; (b) and new and (3) revised...... 28832 (e)(2)(ii) revised ...... 37620 520.2362 (a) removed; (b), (c) and (b)(1), (2) and (d) amended ...... 44278 (d) redesignated as new (a), (b) (b) and (e)(1) revised ...... 53136 and (c); heading and new (a) and (b), (d) and (e)(2)(ii) revised ...... 64116 (c) revised...... 28832 522.23 (b) and (c) revised; (d) and 520.2380a (a) removed; (b) through (e) removed...... 16182 (e) redesignated as new (a) 522.44 Removed...... 16182 through (d); new (b) revised ...... 28832 522.52 (c)(3) amended...... 64116 520.2380b (a) removed; (b) through 522.56 (b) revised ...... 16183 (e) redesignated as new (a) 522.62 Revised ...... 16183 through (d); heading and new 522.82 Revised ...... 16183 (b) revised...... 28832 522.84 Revised ...... 16183 520.2380c (a) removed; (b) through 522.88 Revised ...... 16183 (e) redesignated as new (a) 522.90 Revised ...... 16183 through (d) ...... 28832 522.90a Revised ...... 16183 520.2380d Heading and (c) re- 522.90b Heading revised...... 16184 vised...... 28832 522.90c (b) amended...... 16184 520.2380e Heading and (c) re- 522.144 Revised ...... 16184 vised...... 28832 522.161 Revised ...... 16184 520.2380f Heading, (c) heading, (1) 522.204 (b) amended ...... 16184 and (3) revised...... 28832 522.230 Added ...... 53136 520.2471 Added ...... 18158 522.234 Revised ...... 16184 520.2475 (b) amended ...... 28832 522.246 (b)(1) amended ...... 16184

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21 CFR—Continued 79 FR 21 CFR—Continued 79 FR Page Page Chapter I—Continued Chapter I—Continued (b)(3) amended ...... 74020 522.955 (d)(1)(i)(C) and (ii)(C) re- 522.275 Heading revised ...... 16184 vised...... 18158 522.300 Revised ...... 16185 (c) revised ...... 53136 522.304 (b) amended ...... 16185, 53136 522.956 (d)(3) revised...... 18158 (b) revised ...... 74020 522.960 Revised ...... 16188 522.311 (b) amended ...... 16185 522.960a Revised...... 16188 522.313a (b) amended ...... 16185 522.960b Revised...... 16188 (d) removed; (e) redesignated as 522.960c Revised...... 16188 new (d); new (d)(1)(iii), (2)(iii) 522.970 (b)(2) amended ...... 16189 and (e)(iii) revised ...... 37620 522.995 Revised ...... 16189 522.313c (b) amended ...... 16185 522.1002 (c) added...... 53136 (d) revised ...... 21127 (c)(2) amended...... 74020 522.380 Revised ...... 16185 522.1010 (d)(2)(i)(B) and (ii)(B) re- 522.390 Heading, (a), (b) and (c)(3) vised...... 16189 revised ...... 16185 522.1020 Revised ...... 16189 522.454 Added ...... 37620 522.1044 (b)(4) amended...... 21127 522.460 Revised ...... 16185 522.1066 (b) amended...... 16189 522.468 (b) amended ...... 16185 522.1077 (c)(1)(ii) revised...... 44278 522.480 Revised ...... 16185 522.1081 (b)(1) amended...... 16189 522.522 (b) amended ...... 16185 522.1083 (b) and (c)(3) amended ...... 16189 (d)(1) revised; (d)(2) removed; 522.1085 Revised ...... 16189 (d)(3) redesignated as new (d)(2) 522.1086 Revised ...... 16189 ...... 53136 522.1125 (d)(3) amended...... 16189 522.533 (b)(1) amended ...... 18158 522.1145 Heading, (a)(3)(i), (iii), 522.535 (d) redesignated as (c); (b)(3)(i), (iii), (c)(3), (d)(3)(iii), heading, (a) and new (c)(1)(iii) (f)(3)(i) and (iii) revised; (a)(2) revised ...... 16185 and (b)(2) amended ...... 16189 522.536 Revised ...... 16186 (e)(2)(ii) amended ...... 74020 522.540 Heading, (a)(3)(iii), (b)(1), 522.1150 Heading, (a) and (c)(3) re- (3), (c)(1), (3), (d)(1), (3), (e)(1) vised; footnote 1 removed...... 16190 and (3) revised; (d)(2)(i) and (ii) 522.1155 Revised ...... 16190 amended...... 16186 522.1156 Revised ...... 16190 522.542 Revised ...... 16186 522.1182 (b)(2), (4) introductory 522.563 Revised ...... 16186 text and (5) introductory text 522.650 (b), (c), (d)(1) and (3) re- amended...... 16190 vised...... 16187 522.1185 Added ...... 16190 522.690 (b) amended ...... 16187 522.1193 (e)(3) revised ...... 64116 Heading and (d)(2)(v) revised ...... 44278 522.1204 Revised ...... 16190 (d)(1)(iii) revised ...... 64116 522.1222 Removed; redesignated 522.723 Revised ...... 16187 from 522.1222a; (b) amended ...... 16190 522.770 (a) and (b) amended ...... 16187 (b) revised ...... 74020 522.778 Removed ...... 16187 522.1222a Redesignated as new 522.784 Revised ...... 16187 522.1222 ...... 16191 522.800 Revised ...... 16187 522.1222b Redesignated as 522.812 (b)(2) revised...... 37620 522.1223 ...... 16191 522.814 (d)(2) and (3) revised ...... 37620 522.1223 Redesignated from 522.820 (a) and (b) redesignated as 522.1222b and revised ...... 16191 (b) and (a); (d)(1) introductory 522.1225 Revised ...... 16191 text, (2) introductory text and 522.1228 Removed...... 16191 (3) introductory text re- 522.1242 Redesignated from vised...... 16187 522.1244; heading revised; (a) 522.842 (a)(1) amended ...... 16187 and (b) amended...... 16191 522.863 Revised ...... 16187 522.1244 Redesignated as 522.883 Revised ...... 16188 522.1242 ...... 16191 522.900 (b)(2) amended ...... 16188 522.1260 (b)(1) and (3) amended ...... 16191 522.914 Revised ...... 16188 522.1289 Revised ...... 16191

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21 CFR—Continued 79 FR 21 CFR—Continued 79 FR Page Page Chapter I—Continued Chapter I—Continued 522.1315 (b) amended...... 16191 522.2063 Revised ...... 16195 522.1335 Heading, (a) and (c)(3) re- 522.2076 (c)(3) revised ...... 16195 vised...... 16191 522.2100 Heading, (a)(1), (3), (b)(1), 522.1362 Heading, (c)(1) and (3) re- (3) and (d)(2) revised ...... 16195 vised...... 16191 522.2120 (b) amended...... 16195 522.1367 (b) revised ...... 74020 522.2121 (b) amended...... 16195 522.1372 (b) amended...... 16191 522.2150 Revised ...... 16195 522.1380 Revised ...... 16191 522.2220 Revised ...... 16196 522.1410 (b) amended...... 16191 522.2240 Revised ...... 16196 522.1451 Heading revised; (b) 522.2340 (b) amended...... 16196 amended...... 16191 522.2404 (b) amended...... 16196 522.1452 Heading, (a), (c) heading 522.2424 Revised ...... 16196 and (3) revised...... 16191 522.2444 Revised ...... 16196 522.1465 Heading and (a) revised; 522.2444a Revised ...... 16196 (c)(3) amended ...... 16191 522.2444b Revised ...... 16197 522.1468 (b) amended...... 16192 522.2470 Revised ...... 16197 522.1484 Revised ...... 16192 522.1503 Heading, (a) and (c) re- 522.2473 Added ...... 18159 vised...... 16192 522.2474 Revised ...... 16197 522.1610 Heading, (a) and (c) re- (b) amended ...... 74020 vised...... 16192 522.2477 (b)(3) amended...... 16197 522.1620 (c) revised ...... 16192 522.2478 (b) amended...... 16197 522.1660a (b) and (e)(1)(ii) amend- (a), (d)(1)(i) introductory text, ed ...... 16192 (ii) introductory text and (2) 522.1662a (c)(2), (d)(2), (e)(2) and revised; (d)(1)(iii) and (3) added (h)(2) amended ...... 16192 ...... 64116 522.1662b (b) amended...... 16192 522.2582 Revised ...... 16197 522.1664 (d)(3) revised ...... 16192 522.2610 (b) amended; (c) removed; 522.1680 (b) amended...... 16192 (d) redesignated as new (c); new 522.1696 Revised ...... 16192 (c)(1)(iii) added; new (c)(2)(iii) 522.1696a (b)(1), (3) and (d)(2)(iii) revised ...... 16197 amended...... 16192 522.2615 Heading, (a), (b) and (d) 522.1696b (b)(1), (d)(2)(i)(A) and revised ...... 16198 (iii)(A) amended ...... 16192 522.2630 (d)(1) revised ...... 74020 522.1696c (b) amended; (c) re- 522.2640 (d) and (e) redesignated as moved; (d) redesignated as new (c) and (d); (a), (b), new (c)...... 16193 (d)(1)(iii), (3)(i) and (iii) re- 522.1698 Heading, (a), (b), (c)(1)(i), vised...... 16198 (iii), (2)(i) and (iii) revised ...... 16193 522.2662 (d)(2)(iii) revised ...... 16198 522.1704 Revised ...... 16193 (b)(2) amended ...... 21127 522.1720 Revised ...... 16193 (b)(4) amended ...... 74020 522.1820 Heading and (c) re- 522.2670 Heading and (a) revised...... 16193 vised...... 16198 522.1862 Revised ...... 16193 Revised...... 74020 522.1881 Revised ...... 16194 524.86 Heading, (b) and (c)(3) re- 522.1884 Revised ...... 16194 vised...... 10967 522.1885 Revised ...... 16194 524.154 (a) and (b) redesignated as 522.1890 Revised ...... 16194 (b) and (c); new (a) added; head- 522.1920 Revised ...... 16194 ing, (b) and (c) introductory 522.1940 (a)(1) amended...... 16194 text revised ...... 10967 522.1962 Heading and (c)(1)(iii) re- 524.155 (a) and (b) redesignated as vised; (b)(1) amended...... 16194 (b) and (c); new (a) added; head- 522.2002 Revised ...... 16195 ing, (b) and (c) introductory 522.2005 (b)(3) amended; (c)(3) text revised ...... 10967 added...... 16195 524.390 (b) and (c)(3) revised ...... 10967 522.2012 Revised ...... 16195 524.402 (b) amended ...... 10967

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21 CFR—Continued 79 FR 21 CFR—Continued 79 FR Page Page Chapter I—Continued Chapter I—Continued 524.450 Heading, (b) and (c) intro- 524.1484f Heading, (b) and (c) re- ductory text revised...... 10967 vised...... 10971 524.463 (b) amended ...... 10967 524.1484g Heading and (c) re- 524.575 (c)(1) and (3) revised ...... 10967 vised...... 10971 524.660 Revised ...... 10967 524.1484h Heading, (b) and (c) re- 524.660a Removed ...... 10967 vised...... 10971 524.660b Removed ...... 10967 524.1484i Heading, (b) and (c) re- 524.770 (b) amended; (e)(3) revised...... 10971 vised...... 10967 524.1484j Added ...... 10971 524.802 Heading and (c)(3) re- 524.1484k Added ...... 10971 vised...... 10967 524.1580 Heading revised ...... 10971 524.900 (a) removed; (b) through 524.1580a Removed; new section (f) redesignated as (a) through redesignated from 524.1580b; (e); new (e) revised...... 10968 new (b)(1) revised ...... 10971 524.920 Revised ...... 10968 (b)(1) amended...... 64117 524.960 (b) amended; heading and 524.1580b Redesignated as (c) revised...... 10968 524.1580a; new section redesig- 524.981 Removed ...... 10968 nated from 524.1580c; (b) 524.981a Heading, (c) introduc- amended; (c)(2) footnote 1 and tory text, (1) and (2) revised ...... 10968 (3) footnote 1 removed ...... 10971 524.981b Heading, (a), (c) intro- (b) amended ...... 64117 ductory text, (1) and (2) re- 524.1580c Redesignated as vised...... 10969 524.1580b; new section redesig- 524.981c Heading, (a), (c) intro- nated from 524.1580e; heading ductory text, (1) and (2) re- revised; (c)(2) footnote 1 and (3) vised...... 10969 footnote 1 removed ...... 10971 524.981d Revised...... 10969 524.981e Revised...... 10969 524.1580d Removed...... 10971 524.1005 (b)(1) and (c)(3) amend- 524.1580e Redesignated as ed ...... 10969 524.1580c ...... 10971 524.1044 Heading revised ...... 10969 524.1600a Heading, (b) and (c)(3) 524.1044b Heading revised...... 10969 revised ...... 10972 524.1044c Heading revised...... 10969 524.1600b Heading and (c) re- 524.1044d Heading and (c) revised...... 10972 vised...... 10969 524.1662 Heading revised...... 10972 524.1044e Heading and (c) re- 524.1662a (b) amended; heading vised...... 10969 and (c) revised...... 10972 524.1044g Second (b)(3) removed; 524.1662b (b) amended; heading heading revised ...... 10969 and (c) revised...... 10972 524.1044h Heading revised; (c)(3) 524.1881 Removed...... 10972 added...... 10969 524.1881a Removed...... 10972 524.1132 Heading revised ...... 10969 524.1881b Removed...... 10972 524.1200a Revised ...... 10969 524.1883 Removed...... 10972 524.1200b Revised ...... 10970 524.1982 (b) amended; heading and 524.1204 Revised ...... 10970 (c) revised...... 10972 524.1240 (b) revised ...... 10970 524.2098 (b) amended ...... 10972 524.1446 Heading revised ...... 10970 524.2350 Revised ...... 10972 524.1465 (b) amended...... 10970 524.2620 Revised ...... 10973 524.1484b Heading, (b) and (c) re- 526.313 (b) amended ...... 10973 vised...... 10970 (d) removed; (e) redesignated as 524.1484c Heading, (b) and (c) renew (d); new (d)(1)(iii) and vised...... 10970 (2)(iii) revised ...... 18159 524.1484d Heading, (b) and (c) re- 526.464a (d) removed...... 10973 vised...... 10970 526.464d Removed ...... 10973 524.1484e Heading, (b) and (c) re- 526.820 (b) removed...... 10973 vised...... 10970 526.1130 Heading revised ...... 10973

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21 CFR—Continued 79 FR 21 CFR—Continued 79 FR Page Page Chapter I—Continued Chapter I—Continued 526.1590 (a)(2) and (b)(2) amended; 558.62 Removed...... 10982 heading revised ...... 10973 558.76 (d)(3) revised ...... 10982 526.1696c (b) amended...... 10965 (a) and (d)(1) table amended ...... 13544 526.1696d (b) amended...... 10973 (d)(3)(vii) removed ...... 44278 526.1810 (b) amended...... 10973 (d)(1)(x) amended ...... 74021 529 Drug application approvals 558.78 (d)(3) revised ...... 10982 withdrawn ...... 2786 (b), (d)(1) table and (2)(ii) amend- 529.40 (c) removed; (d) redesig- ed...... 13544 nated as (c); new (c)(3) re- 558.95 (d)(5)(iii) through (x) redes- vised...... 10973 ignated as (d)(5)(iv) through 529.56 (b) amended...... 10973 (xi); new (d)(5)(iii) added ...... 10965 529.382 Added ...... 37621 (d)(5) revised ...... 10982 529.400 Heading revised; (b) (a)(2), (d)(2)(i), (ii), (3)(i) and (ii) amended; (c)(1) footnote, (2) amended ...... 19815 footnote and (3) footnote re- 558.105 Removed ...... 74021 moved ...... 10973 558.120 Removed ...... 10982 529.778 Added ...... 10973 529.1030 (d)(1)(i), (ii), (2)(i) and (ii) 558.128 (e)(7) revised ...... 10982 removed; (d)(1)(iii), (iv), (v), (b)(1), (e)(1) through (5) tables, (2)(iii), (iv) and (v) redesig- (6)(iv) and (5) amended...... 13544 nated as (d)(1)(i), (ii), (iii), 558.140 (a) amended; (c)(3) re- (2)(i), (ii) and (iii); new (d)(2)(ii) vised...... 13544 and new (iii) revised...... 2786 Revised...... 37622 529.1044 Amended...... 10973 558.145 (a)(1) and (2) amended...... 13544 529.1044a Heading and (b) re- (a)(2) amended...... 37623 vised...... 10973 558.155 (a)(1) and (2) amended...... 13545 529.1044b Heading and (c) re- Removed...... 15541 vised...... 10973 558.175 (d)(9) redesignated as 529.1115 (b) and (c)(3) revised; (d)(11); (d)(5) through (8) redes- (c)(1) footnote, (2) footnote and ignated as (d)(6) through (9); (3) footnote removed ...... 10973 new (d)(5) and (10) added ...... 10965 529.1660 (b)(1) and (2) amended ...... 10973 (d)(3) and (8) removed; (d)(4) 529.1940 (b), (c) and (e)(1)(iii) through (7) redesignated as amended; (e)(1)(ii)(D) added ...... 10965 (d)(3) through (6); (d)(9), (10) Amended ...... 10974 and (11) redesignated as (d)(7), (d) revised; (e)(1)(i) and (iii) (8) and (9)...... 10982 amended ...... 44278 (d) table and (6) amended ...... 13545 529.2464 Revised ...... 10974 558.195 (e)(1)(iv) and (v) removed; 529.2503 Revised ...... 2786, 10974 (e)(1)(vi) through (ix) redesig- 556 Drug application approvals nated as (e)(1)(iv) through withdrawal...... 10974 (vii) ...... 10982 Technical correction ...... 18990 (b), (e)(1) table, (2) table and (3) 556.60 Revised ...... 10979 table amended...... 13545 556.118 Added ...... 37621 (e)(1)(vii) correctly removed ...... 17860 556.344 (a), (b)(1)(i) and (2)(ii) re- 558.198 (d)(1)(iii), (iv) and (vi) revised; (c) added ...... 64117 moved; (d)(1)(v), (vii) and (viii) 558 Drug application approvals redesignated as (d)(1)(iii), (iv) withdrawal...... 10974 and (v) ...... 10982 Technical correction ...... 18990 (d)(1) table and (2) table amended Drug application approvals with- ...... 13545 drawn ...... 19816, 37621 558.248 (d)(3) removed; heading re- 558.4 (d) table amended ...... 10979, 15541, vised...... 10982 37621, 44278 558.258 (e)(2)(ii) through (vii) ta- 558.55 (d)(1), (2) and (3) revised; bles amended ...... 13545 (d)(4) added ...... 10979 558.261 (e)(2)(ii) and (iii) amend- 558.58 (e) revised ...... 10980 ed ...... 18159

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21 CFR—Continued 79 FR 21 CFR—Continued 79 FR Page Page Chapter I—Continued Chapter I—Continued 558.265 (d)(1)(v), (viii) and (3)(ii) 558.430 (a) revised; (b) and (c) re- removed ...... 10982 designated as (c) and (d); new 558.274 Revised ...... 10982 (b) added ...... 13545 (a) introductory text, (c)(1)(i) 558.460 (d)(2) removed...... 10983 and (2)(i) amended; (a)(2) and (b), (d)(1)(i) table, (ii) and (iii) (3) removed; (a)(4) redesig- amended ...... 13545 nated as new (a)(2) ...... 19815 558.464 (a)(1) and (2) amended...... 13545 558.305 (b) and (e) table amend- 558.485 (b)(7) and (e)(1)(xii)(C) ed ...... 13545 amended...... 13546 558.311 (e)(1)(ii) and (xv) amended; (b)(3) and (6) removed ...... 19815 (e)(5) revised ...... 10983 558.500 (e)(2)(viii) and (x) amend- (b)(1) through (4), (6), (7), (e)(1) ed ...... 13546 table, (2)(v), (3)(v) and (4)(v) (e)(1)(ii), (iii), (iv), (2)(viii), (ix), amended ...... 13545 (x) and (xiii) amended ...... 37621 558.325 (d)(3) revised...... 10983 (e)(2)(viii) table and (x) table (a)(1), (c)(3)(i), (d)(1) table and (2) amended ...... 44278 table amended...... 13545 (e)(2)(ii), (iv), (vii), (ix), (x), (xii) (a) through (d) redesignated as and (xiii) revised ...... 53136 (b) through (e); new (a) added; 558.515 (d) amended ...... 10983 new (b) revised; new (e)(2) (a) and (d) table amended ...... 13546 amended ...... 19815 558.530 Removed ...... 10983 558.340 Heading revised ...... 10983 558.550 (d)(1)(ii), (iv), (v), (viii), (a) amended ...... 13545 (ix), (xii), (xiv), (xv), (xvii), 558.342 (b)(1) and (e)(1) table (xviii), (xix), (xxiv), (3)(iv), (vi) amended...... 13545 and (vii) removed ...... 10983 558.348 (a) amended ...... 13545 (b)(1), (d)(1)(iii)(c), (vi)(c), 558.355 (f)(1)(ii), (vii), (x), (xi), (vii)(c), (xiii)(c), (xvi)(c), (xii), (xv), (xvi), (xvii), (xviii), (xx)(c), (xxi)(C), (xxii)(B), (xix), (xx), (xxiii), (xxvi), (xxiii)(b), (3)(ii)(B), (iii)(B), (xxvii), second (4)(iv), (vi) and (v)(B) and (4)(i)(b) amended ...... 13546 (vii) removed ...... 10983 (d)(1)(i)(c) and (2)(i)(c) amended (b)(8), (9), (11), (f)(1)(iii)(b), ...... 18159 (iv)(b), (v)(b), (vii)(b), (xiv)(b), (d)(1)(xxii)(B) amended ...... 53138 (xxv)(b), (xxix)(b), (xxx)(b), 558.555 (d)(3), (4) and (8) removed; (2)(ii)(b), (iii)(b), (4)(ii)(b), (d)(5), (6) and (7) redesignated (iii)(b), (iv)(b) and (v)(b) as (d)(3), (4) and (5)...... 10983 amended; (f)(1)(i)(b) revised...... 13545 (d)(2), (3), (4) and (8) amended ...... 13546 (b)(3) correctly removed ...... 17860 558.575 (d)(1)(ii) removed...... 10983 (f)(1)(xxxi) added ...... 74021 (a)(1) amended...... 13546 558.363 (a)(2), (5), (6), (d)(1)(ii), (v), 558.582 (a) amended ...... 13546 (vii), (viii), (ix), (3)(iii) and (iv) 558.600 (e)(1)(iii) amended ...... 13546 removed; (d)(1)(iii) and (iv) re- 558.625 (b)(10) added; (b)(54) designated as (d)(1)(ii) and (iii); amended; (b)(57) and (83) re- (d)(1)(vi) redesignated as moved ...... 13546 (d)(1)(iv); (d)(1)(x) and (xi) re- (b)(2) through (24), (26) through designated as (d)(1)(v) and (38), (40) through (53) and (55) (vi) ...... 10983 through (88) removed; (b)(25), (a)(6), (7), (d)(1)(vi)(B) and (x)(B) (39), (54), (89) and (90) redesig- amended ...... 13545 nated as new (b)(2) through (6) 558.364 (a) and (d) table amend- ...... 19815 ed ...... 13545 558.630 (b)(5) amended ...... 13546 558.366 (d) table amended .....10983, 13545 (b) revised ...... 19815 558.369 (a) amended ...... 13545 558.635 (a)(2) amended ...... 13546 558.415 (a) revised; (b) and (c) re- (d)(4)(v), (vi) and (vii) correctly designated as (c) and (d); new revised...... 17860 (b) added ...... 13545 (a) revised ...... 19815

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21 CFR—Continued 79 FR 21 CFR—Continued 80 FR Page Page Chapter I—Continued Chapter I—Continued 558.680 (d) revised...... 10983 520.312 Redesignated as 520.302 ...... 13229 (b) amended ...... 13546 520.370 (a) and (b) revised; (c)(2) 573.210 Added ...... 14176 amended...... 13229 520.441 (b)(1) amended ...... 13229 2015 (b)(4) amended ...... 18775 520.446 (b)(1) amended ...... 76386 21 CFR 80 FR Page 520.580 (d) heading restored; CFR correction ...... 12081 Chapter I 520.804 (c)(i), (ii) and (iii) redesig- 500.23 Revised ...... 56337 nated as (c)(1), (2) and (3)...... 34278 507 Added ...... 56337 520.905a (a) and (e)(4)(i) revised; Policy statement ...... 56360 (e)(4)(iii) amended; (e)(5) 507.3 Eff. date pending in part...... 56337 added...... 76386 507.12 Eff. date pending in part ...... 56337 520.1156 Added ...... 18775 Regulation at 80 FR 56145 eff. 520.1193 (b)(2) corrected; CFR cor- date confirmed in part...... 74354 rection ...... 12081 507.105 Eff. date pending in 520.1315 (c)(1) revised ...... 53459 part ...... 56337 520.1367 (b)(2) amended...... 53459 Regulation at 80 FR 56145 eff. 520.1443 (b) amended...... 18776 date confirmed in part...... 74354 520.1447 (b) amended...... 18776 507.110 Eff. date pending in 520.1510 Heading and (b) revised; part ...... 56337 (d)(1)(ii)(B) amended...... 18776 Regulation at 80 FR 56145 eff. 520.1660d (b)(6), (d)(1)(ii)(A)( ), date confirmed in part...... 74354 3 507.130 Eff. date pending in (B)(3) and (C)(3) amended ...... 13229 part ...... 56337 (a)(4) revised ...... 34278 Regulation at 80 FR 56145 eff. 520.1855 (b) amended ...... 34278 date confirmed in part...... 74354 (c)(1) revised ...... 53459 507.135 Eff. date pending in 520.2043 (b)(2) amended...... 76386 part ...... 56337 520.2158 (b) amended...... 18776 507.175 Eff. date pending in (d)(1) and (2) revised; (d)(3) added part ...... 56337 ...... 61296 Regulation at 80 FR 56145 eff. 520.2218 (d)(1)(i)(A), (B), (2)(i)(A) date confirmed in part...... 74354 and (B) revised ...... 34278 510.600 (c)(1) table and (2) table 520.2261b (d)(4)(iii) amended...... 61296 amended...... 13228, 18775, 34278, 61295, 520.2455 (b)(3) and (c) revised...... 13229 73104, 76386 520.2598 (a) amended...... 53460 514 Authority citation revised ...... 31733 520.2640 (e)(2)(iii) and (3)(iii) 514.1 (b)(9) revised...... 31733 amended...... 34278 520 Drug application approvals 522 Drug application approval withdrawn...... 76387 withdrawn...... 18777 520.43 (c)(2) revised ...... 18775 522.167 Added ...... 18776 520.48 (b) revised ...... 34278 522.230 (b) amended ...... 18776 520.88g (c)(2)(i) amended ...... 34278 522.246 (b)(3) amended ...... 13229 520.154a Heading revised; 522.558 (a) and (b) revised...... 13229 (d)(1)(ii), (2)(i)(A), (ii)(A), (3)(ii) 522.690 (d)(1) and (2) redesignated and (4)(ii) amended ...... 34278 as (d)(2) and (4); new (d)(1) 520.301 Redesignated from added; new (d)(2)(ii) and (3)(ii) 520.310...... 13229 amended; (a), (b), (c) and new 520.302 Redesignated from (d)(4) introductory text re- 520.312...... 13229 vised...... 61296 520.304 Redesignated from 520.309; (b)(2) and (d)(1)(i) revised; (b)(3) (b)(3) added ...... 13229 added ...... 76386 (b)(3) amended ...... 34278 522.812 (e)(3)(i) removed; (e)(3)(ii) (b)(2) amended...... 61296 and (iii) redesignated as new 520.309 Redesignated as 520.304 ...... 13229 (e)(3)(i) and (ii); (b)(2) and new 520.310 Redesignated as 520.301 ...... 13229 (e)(3)(i) revised ...... 13229

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21 CFR—Continued 80 FR 21 CFR—Continued 80 FR Page Page Chapter I—Continued Chapter I—Continued (b)(3) added ...... 18776 558.76 (d)(1)(iv) amended ...... 13230 (b)(2) revised ...... 61296 (d)(3)(xiii) removed ...... 78970 522.955 (a), (b), (d)(1) heading, (i) (b), (c) and (d) redesignated as (c), introductory text, (C), (ii) in- (d) and (e); new (b) added; head- troductory text and (C) re- ing, (a) and new (e)(1) revised vised...... 61296 ...... 79474 (b)(2) amended...... 76386 558.95 (d)(4)(v) added ...... 13230 522.1004 Removed...... 18776 (d)(4)(ii) table amended ...... 53460 522.1073 Removed...... 34278 558.128 (b)(1), (e)(1)(i), (ii), (iii), 522.1075 Removed...... 34278 (2)(i) through (iv), (3)(i) 522.1077 Revised ...... 34279 through (iv), (4)(i), (ii), (iv), 522.1145 (e)(2)(i) amended ...... 34279 (vii), (viii) and (5)(i) amended; 522.1222 (b) revised ...... 13229 (e)(1)(iv), (4)(v) and (ix) re- 522.1289 (a) amended...... 61297 vised...... 13231 522.2005 (b)(2) revised; (b)(3) re- (b)(2), (e)(1) table, (2) table, (3) moved ...... 18776 table, (iv) and (4) table amend- 522.2075 Added ...... 61297 ed...... 18776 522.2470 (b) revised ...... 34279 558.140 (b)(1) amended ...... 13231 522.2474 (b) amended ...... 13230 558.145 (a)(2) amended ...... 13231 522.2483 (b) revised ...... 34279 558.195 (e)(2)(iv) amended...... 13231 522.2630 (b)(1), (2), (d)(1)(ii)(A), (B) 558.261 (c)(1) and (2) revised ...... 76387 and (iii) revised...... 13230 558.355 (f)(1)(xiv)(b) amended ...... 13231 522.2662 (b)(4) amended...... 13230 522.2670 (b)(1) amended...... 13230 558.369 Removed ...... 78970 524.154 (a)(1), (2) and (b)(2) re- 558.450 (a)(2), (d)(1)(i) through vised...... 61297 (iv), (2)(i) through (iv), (3)(i), 524.955 Added ...... 13230 (ii), (4)(i) through (v), (5)(i), (ii) 524.957 Added ...... 76387 and (iii) amended ...... 13232 524.1044a Revised ...... 18776 558.455 (b), (e)(1)(i) through (iv), 524.1044i (c)(2) revised ...... 13230 (2)(i) through (iv), (3)(i), (ii) and 524.1450 (a), (b) and (d) revised; (e) (4)(i) through (vi) amended...... 13232 removed ...... 53460 558.460 (a) and (b) revised...... 61298 524.1484g (a) and (b) revised ...... 61297 558.500 (e)(1)(ii), (iii), (iv), (2)(iv), 526.313 (d)(1)(ii) revised ...... 34279 (ix), (x) and (xiii) amended...... 61298 528.1070 (b) amended ...... 34279 558.550 (b)(3) and (d)(1)(xvi)(c) 528.1092 Added ...... 73104 amended...... 13232 529.1186 (b) amended...... 18776 558.600 Redesignated as 558.612; 529.1350 (b) amended...... 18776 redesignated from 558.615 ...... 13232 529.2150 (b) amended...... 18776 558.612 Redesignated from 558.600; 556.60 Removed...... 78970 (c) and (e)(1)(iii) amended...... 13232 556.68 Added ...... 61297 558.615 Redesignated as 558.600 ...... 13232 556.732 Redesignated from 558.618 (e)(2)(i) amended...... 61298 556.738...... 13230 (c)(1) revised ...... 76387 556.738 Redesignated as 556.732 ...... 13230 558.625 (b)(5) amended ...... 13232 558 Authority citation revised ...... 31733 (b)(5) removed; (b)(6) redesig- Policy statement ...... 58602 nated as new (b)(5) ...... 76387 Drug application approvals with- 558.630 (b)(2) amended ...... 13232, 76387 drawn ...... 61298, 76387, 78970 558.665 (d)(1) and (e)(1) revised; 558.3 (b)(1)(ii), (6), (7), (9) and (11) (d)(2) redesignated as (d)(4); revised; (b)(12) added...... 31733 new (d)(2), (3), (e)(7) and (8) 558.4 (d) table amended ...... 61297, 78970 added...... 13232 558.6 Revised ...... 31733 (e)(9) added...... 18776 (b)(5) and (c) introductory text (d)(2) and (e) revised ...... 53460 corrected ...... 35841 573.490 Added ...... 35569 558.68 Added ...... 61297 578.3 Amended ...... 75804 (c)(1) revised ...... 76387 578.87 (b)(4) amended...... 75804

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21 CFR—Continued 80 FR 21 CFR—Continued 81 FR Page Page Chapter I—Continued Chapter I—Continued 578.103 (a)(4) through (17) redesig- 520.284b Redesignated from nated as (a)(5) through (18); 520.300b...... 59133 new (a)(4) added ...... 75804 520.284c Redesignated from 579.12 Amended...... 56356 520.300c ...... 59133 520.292 Added ...... 59133 2016 520.300 Redesignated as 520.284 ...... 59133 21 CFR 81 FR 520.300a Redesignated as Page 520.284a...... 59133 Chapter I 520.300b Redesignated as 507 Nomenclature change ...... 49897 520.284b...... 59133 Policy statement ...... 57784, 75693 520.300c Redesignated as 507.3 Amended...... 3717 520.284c ...... 59133 Regulation at 80 FR 56337 eff. 520.441 (b)(2), (d)(1)(i)(A)(1), date confirmed in part...... 64060 (2)(i)(A)(1), (4)(iii)(B), (C) and 507.5 (e)(5) revised ...... 3717 (iv)(B) amended ...... 17607 507.7 (b)(2)(i)(B) and (ii) re- (b)(2) removed; (b)(3) and (4) revised ...... 3717 designated as new (b)(2) and (3); 507.19 (b)(2) revised...... 3717 (b)(1) and new (2) revised ...... 22523 507.27 (b) revised...... 3717 (d)(1)(i)(A)(2), (2)(i)(A)(2), 507.33 (c)(1) revised ...... 3717 (4)(i)(A)(2), (B)(2), (ii)(A)(2), 507.36 (a)(2) introductory text, (3) (B)(2), (iii)(C), (iv)(C), introductory text, (5) and (b)(5) (5)(i)(A)(2), (ii)(A)(2), (iii)(C) revised ...... 3717 and (iv)(C) amended ...... 94989 507.47 (b)(1)(i)(A) and (B)(1) re- 520.443 (b), (d)(1)(i), (2)(i) and (3)(i) vised ...... 3718 amended...... 17607 507.50 (c)(1) revised ...... 3718 520.445 (b) amended ...... 17607 507.51 (a)(4)(iii) revised...... 3718 (d)(3) amended ...... 94989 507.65 (e) revised...... 3718 520.446 (b)(1) amended ...... 17607 507.69 (a)(1) revised...... 3718 520.447 (b) amended ...... 17607 510.600 (c)(1) table and (2) table amended ...... 3324, 17606, 36788, 48702, 520.823 (d)(2)(ii) amended ...... 17607 59133, 67151 (d)(1)(i), (iii), (2)(i), (iii), (3)(i) and 514 Authority citation revised ...... 29141 (iii) revised ...... 94989 Technical correction ...... 89848 520.905a (a) amended ...... 22523 514.80 (b)(4) introductory text 520.928 (c) revised...... 67151 amended; (b)(4)(i) revised...... 29141 520.1010 (b)(3) amended...... 17607 514.87 Added ...... 29141 520.1044a (d)(3) revised ...... 94989 514.111 (a)(12) added...... 60221 520.1044b (b) Amended ...... 22523 514.200 Revised ...... 52997 520.1044c (d)(3) revised; (d)(4) re- 515 Technical correction...... 89848 moved ...... 94989 515.10 (b)(8) amended...... 60221 520.1084 Added ...... 36789 516.1318 Removed ...... 3324 520.1193 (b)(2) amended...... 17607 520 Drug application approvals 520.1248 Added ...... 22523 withdrawn...... 36790 520.1263c (b) revised...... 22523 520.88b (b)(1)(ii)(B) amended ...... 17607 (b)(1), (d)(1)(iii), (2)(iii) and 520.100 (b)(3) removed...... 22523 (3)(iii) amended...... 94989 (b)(3) and (4) removed ...... 59133 520.110 (b) amended ...... 48702 520.1265 (d)(3) added...... 94989 (d)(3) amended ...... 94989 520.1430 Heading revised ...... 36789 520.154b Heading revised; (a) 520.1484 (b)(2) and (3) amended ...... 22523 amended...... 17607 (e)(1)(iii) and (2)(iii) revised ...... 94989 520.284 Redesignated from 520.1660a Heading, (e)(1) and (3) 520.300...... 59133 revised ...... 94989 520.284a Redesignated from 520.1660d (b)(2) and (3) amend- 520.300a...... 59133 ed ...... 22523

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21 CFR—Continued 81 FR 21 CFR—Continued 81 FR Page Page Chapter I—Continued Chapter I—Continued (d)(1)(i)(A)(1), (3), (B)(1), (3), 522.150 (b) amended ...... 48702 (ii)(A)(1), (3), (B)(1), (3), (C)(1), 522.224 Added ...... 67151 (3), (iii)(A), (C), (iv)(A), (iv)(C), 522.390 (b) amended ...... 17608 (v)(A), (v)(C), (2)(i) and (iii) re- 522.535 Revised ...... 22524 vised ...... 94989 522.540 (e)(2) amended ...... 17608 520.1696b (b) amended...... 22523, 36789 (a)(2)(i) and (d)(2)(i) amended...... 22524 (c) redesignated as (d); new (c) 522.690 (b)(3) amended ...... 36789 added; new (d)(3) revised ...... 94990 522.810 (b) amended ...... 17608 520.1705 (a) amended ...... 22523 522.840 (b) amended ...... 48702 520.1720a (b)(2) amended...... 17607 522.842 (a)(2) amended ...... 48702 520.1870 (b) revised ...... 17607 522.1044 (b)(4) amended...... 22524 520.2041 (b) amended ...... 22523 522.1055 Added ...... 22524 520.2043 (b)(1) amended...... 17607 Revised...... 59134 520.2044 (b)(2) amended...... 17607 522.1066 (b) amended...... 17608 520.2075 (a) and (c) revised ...... 59133 522.1077 (b)(3) amended...... 36789 520.2086 Added ...... 22523 522.1182 (b)(6) amended; (b)(8) re- 520.2123b (d)(1)(i) removed; moved ...... 22524 (d)(1)(ii) and (iii) redesignated (b) introductory text, (7) intro- as new (d)(1)(i) and (ii); (d)(2) ductory text, (i) and (ii) amend- amended...... 94990 ed...... 59134 520.2123c (b) amended...... 22523 522.1192 (b)(2) amended...... 59134 520.2130 (b) amended ...... 48702 522.1260 (b)(2) amended...... 59134 520.2134 (b) amended ...... 48702 522.1315 (c)(1)(i) and (2)(i) amend- 520.2184 (d)(3) amended...... 94990 ed ...... 22524 520.2200 (b) amended...... 17607 522.1660a (b) amended...... 22524 (d)(1)(iii) and (2)(iii) amended ...... 94990 522.1662a (b)(3)(i)(b), (c)(3)(i), 520.2218 (b) amended ...... 22523 (d)(3)(i)(a), (e)(3)(i)(b), (d)(1)(ii) and (2)(ii) amended ...... 94990 (g)(3)(i)(b) and (k)(3)(ii) amend- 520.2220a (b)(1) amended...... 22523 ed ...... 17608 Heading, (d)(1)(iii), (2)(iii) and (h)(2) and (i)(2) amended ...... 22524 (3)(iii) revised ...... 94990 522.1680 (b) amended...... 36789 520.2260a (a)(1) amended...... 17607 522.1684 Added ...... 36789 520.2260b (f)(1) amended ...... 22523 (b) amended ...... 48702 520.2261a (b) amended...... 17607, 36789 522.1696a (b)(2) amended...... 22524 (d)(3) amended ...... 94990 522.1696b (b)(1) amended...... 22524 520.2261b (b) amended...... 17607 522.1870 (a), (c)(1)(i), (iii), (2)(i) (d)(1)(iii), (2)(iii), (3)(iii) and and (iii) revised...... 67151 (4)(iii) amended...... 94990 522.1940 (a)(2) amended...... 48702 520.2325a (a)(1) and (3) amend- 522.2005 (b)(1) amended...... 36789 ed ...... 22523 522.2112 (b) amended ...... 48702 (a)(2) removed; (a)(3) and (4) re- 522.2120 (b) amended ...... 22524 designated as new (a)(2) and (3) 522.2220 (b)(3) amended...... 22524 ...... 36789 522.2260 (b) amended...... 17608 (a)(3) amended ...... 59134 522.2471 (b) amended ...... 48703 (d) amended ...... 94990 522.2476 (a)(1) amended...... 48703 520.2345c (d)(1)(iii) removed ...... 67151 522.2477 (b)(1) amended...... 48703 520.2345d (b)(5), (d)(1)(ii), (iii), 522.2615 (b) amended...... 22524 (2)(ii) and (iii) amended ...... 17607 522.2630 (d)(1)(iii)(A) revised ...... 67151 (b)(2), (3), (d)(1)(iii) and (2)(iii) 522.2640 (b)(1) amended...... 48703 amended ...... 22523 Revised...... 67151 (d)(1)(iii), (2)(iii), (3)(iii) and 524.916 (b) amended ...... 48703 (4)(iii) amended...... 94990 524.998 Added ...... 67152 520.2471 (d)(2) revised ...... 17608 524.1044g (b)(3) amended...... 17608 (b) amended ...... 48702 (b)(3) correctly amended ...... 18749 520.2640 (b)(1) amended...... 48702 524.1044h (a) and (b) revised ...... 59134 522.56 (b) amended...... 17608 524.1193 (b)(2) amended...... 22524

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21 CFR—Continued 81 FR 21 CFR—Continued 81 FR Page Page Chapter I—Continued Chapter I—Continued (b)(2) correctly amended ...... 25328 558.175 (d)(2) amended ...... 17609 524.1445 (b) amended ...... 48703 (b) amended; (c) and (e) added; 524.1484k Heading revised ...... 22524 (d)(5) and (6) removed ...... 95004 Heading correctly revised ...... 25328 558.195 (e)(1)(ii) amended...... 17609 528.2010 Added ...... 17608 (e)(1)(i) table, (2)(i) table, (3)(i)1 529.400 (a) footnote 1 removed...... 67152 table, (ii)1 table, (i)2 table and 529.539 Added ...... 17608 (ii)2 table amended...... 22525 529.1660 (b)(2) amended...... 22524 (e)(1)(vi), (2)(iii) and (v) amended (d)(3) added ...... 94991 ...... 67152 556.70 (b) amended; (c) added ...... 17608 (e)(1)(iv), (v), (vi), (2)(ii), (iv) and 556.275 (b)(2)(i) amended; (b)(3) (vii) removed; (e)(4) added ...... 95004 and (4) redesignated as (b)(4) 558.198 (d)(1)(ii) and (2)(ii) amend- and (5); new (b)(3) and (c) ed ...... 17609 added...... 22524 (d)(1)(iv) and (v) removed; (d)(3) 556.283 (b)(3) and (4) revised ...... 17608 added ...... 95004 556.480 Removed ...... 94994 558.248 (a) and (b) revised; 556.690 Removed ...... 17608 (d)(1)(iii) removed...... 36790 556.748 (c) revised...... 36789 (d) redesignated as (e); new (d) 556.765 (b)(1)(i) revised; (b)(1)(ii) added; (a) and new (e) revised and (c) added...... 17608 ...... 95004 558 Drug application approvals 558.258 (e)(2)(vi) and (vii) amend- withdrawn...... 36790, 59135, 95025 ed ...... 17609 558.3 (b)(1)(i) and (ii) revised; (e)(2)(ii) through (v) removed; (b)(13) and (14) added ...... 57800 (e)(6) added...... 95005 Regulation at 81 FR 57800 eff. 558.261 (c)(2)(i) and (ii) redesig- date confirmed...... 85873 nated as (c)(2)(ii) and (i); new 558.4 (c) amended; eff. 4-6-16...... 11665 (c)(2)(ii) revised; (c)(4) (d) table amended...... 17608, 36790, 59134, added...... 17609 94995 (c) and (d) redesignated as (d) and 558.15 Removed...... 11665 (c) ...... 67152 558.55 (d)(2)(ii) amended...... 17609 558.265 (d)(1)(vi) and (2)(ii) amend- 558.58 (e)(4) amended...... 17609 ed ...... 17609 (e)(6) amended...... 67152 (d)(1)(iii), (iv) and (vii) removed; (e)(2), (7), (8), (10) and (11) re- (d)(4) added ...... 95005 moved; (f) added ...... 94995 558.274 (a)(1), (c)(1)(i), (ii), (2)(i) 558.59 Revised ...... 67152, 94995 and (ii) amended ...... 48703 558.68 (e)(3) removed ...... 17609 (c)(1)(ii) and (2)(ii) removed ...... 59135 (b) amended ...... 48703 Revised...... 95005 (a) and (e) revised ...... 59134 558.295 (b) removed...... 67152 (c) and (d) redesignated as (d) and 558.300 (e)(2), (3) and (9) amend- (c); (e)(1)(i) and (2)(i) amended ed ...... 17609 ...... 67152 (e)(4) through (7) removed; (f) 558.76 (e)(2) removed; (e)(3) redes- added ...... 95005 ignated as new (e)(2) and re- 558.305 (e)(2), (3), (5) and (6) revised...... 17609 moved; (e)(4) redesignated as (e)(2)(iii) through (xvi) redesig- new (e)(2); (f) added ...... 95005 nated as (e)(2)(iv) through 558.311 (e)(1)(iv), (x) and (xv) (xvii); new (e)(2)(iii) added ...... 94995 amended...... 17609 558.128 (e)(7)(ii) amended...... 17609 (e)(1)(i), (vi), (vii) and (xv) (e)(7)(xi) amended ...... 67152 amended; (e)(1)(iii), (v) and (xx) Revised...... 94995 through (xxviii) removed; 558.140 (b)(2) amended ...... 63054 (e)(5)(i) redesignated as (d) redesignated as (e); new (d) (e)(5)(ii); new (e)(5)(i) and (iii) added ...... 95004 added ...... 95005 558.145 (a)(2) removed...... 63054 558.325 (d)(3) revised...... 67152 Removed...... 95004 Revised...... 95005

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21 CFR—Continued 81 FR 21 CFR—Continued 81 FR Page Page Chapter I—Continued Chapter I—Continued 558.340 (c)(1)(i) and (ii) redesig- (e)(1)(ii), (iii), (iv), (2)(iv), (ix), (x) nated as (c)(2) and (3); new (c)(2) and (xiii) removed; (e)(4) added revised ...... 22525 ...... 95013 558.342 (b)(2), (e)(1)(i) through 558.515 (d) amended ...... 17609 (iv), (ix) and (x) amended ...... 48703 (d) table amended...... 22525 (e)(1)(iv), (ix), (x) and (xi) amend- (d) table amended; (e) added...... 95013 ed...... 67152 558.550 (d)(1)(iii)(a), (c), (vi)(a), (e)(1)(iii), (iv), (viii), (ix) and (xi) (c), (xx)(A), (C), (xxi)(A), (C), removed; (e)(2) revised ...... 95009 (3)(ii) introductory text, (B), 558.355 (f)(1)(iii)(b), (xxiv), (xxix) (iii) introductory text, (B), (v) introductory text, (b), (xxx) in- introductory text and (B) troductory text, (b), (2)(ii) in- amended...... 17609 troductory text, (b), (iii) intro- (b)(1), (d)(1)(xvi)(c), (xx)(C), ductory text, (a), (b), (4)(ii) in- (xxii)(B), (xxiii)(b), (3)(ii)(B), troductory text, (b), (iii) intro- (iii)(B), (v)(B) and (4)(i)(b) ductory text, (b), (v) introduc- amended; (b)(2) removed; (b)(3) tory text and (b) amended...... 17609 redesignated as new (2) ...... 22525 (f)(1)(xxiv) and (xxv) introduc- (d)(1)(xxii)(B) amended ...... 48703 tory text revised; (f)(1)(xxx), (d)(1)(xxii) removed...... 59135 (4)(iv) and (v) removed ...... 22525 (d)(1)(x), (xi), (xiii) and (xvi) re- (b)(1), (2), (4) through (9), (11), moved; (d)(4) revised ...... 95013 (12), (14), (f)(1)(xiii)(b), (xxi)(b), 558.555 (d)(2) amended ...... 17609 (xxii)(b), (xxviii)(b), (xxix)(b), (d)(3), (4), (5), (e)(2), (3) and (4) re- (xxxi)(b), (3)(i)(b)(2)(iii), (ii)(b), moved; (f) added ...... 95013 (xii)(b), (4)(ii)(b), (iii)(b) and 558.575 Heading and (a) revised; (6)(i)(b)(2)(iii) amended...... 48703 (b), (c) and (d) redesignated as (f)(1)(xxviii) removed; (f)(8)(i) (c), (d) and (e); new (b) and (d) and (ii) revised ...... 59135 added...... 95013 (a) and (b) and (f)(8) revised; 558.582 Revised ...... 95013 (f)(1)(viii), (ix), (xiii), (xiv), 558.586 (b) amended ...... 22525 (xxi), (xxii), (xxxi), (2)(iv), Revised...... 95013 (3)(ii) and (xii) removed ...... 95009 558.612 (e)(1)(i) and (iii) removed; 558.363 (d)(1)(iv) introductory (e)(1)(ii) and (iv) redesignated text, (B) and (3)(ii) amended ...... 17609 as new (e)(1)(i) and (ii); (e)(2) (a)(1), (3), (8), (d)(1)(ii)(B), added...... 95015 (iii)(B), (iv)(B), (v)(B) and 558.618 (b), (e)(1)(i) and (2)(i) (vi)(B) amended ...... 48703 through (iii) amended ...... 48703 (d)(1)(vi) removed...... 59135 (e)(2)(ii) and (iii) amended ...... 59135 558.364 (d) redesignated as (e); (a) (c) and (d) redesignated as (d) and through (d) revised ...... 95009 (c) ...... 67153 558.366 (d) amended ...... 17609 558.625 (b)(3) removed; (b)(4) and (b) and (d) amended ...... 48703 (5) redesignated as new (b)(3) (d) amended ...... 67153 and (4)...... 36790 (d) table amended; (e) added...... 95009 (b)(1), (f)(2)(i), (iii) and (vii) re- 558.435 Removed ...... 95009 vised; (f)(2)(viii) and (ix) re- 558.450 (d)(5)(v) amended ...... 17609 moved...... 59135 Revised...... 95009 (b)(1) amended ...... 48703 558.455 (d) revised; (e)(1)(i), (2)(i), (d) removed; (c), (e) and (f) redes- (3)(i), (4)(i), (ii) and (iv) re- ignated as (d), (c) and (e); (b), moved; (e)(4)(v) amended ...... 95012 new (d) and new (e) revised ...... 95015 558.460 Removed ...... 95013 558.630 (b)(1) amended ...... 48703 558.485 (e)(1)(v) through (xii) re- (b)(1) revised ...... 59135 moved; (e)(3) added ...... 95013 Revised...... 95021 558.500 (b), (e)(1)(i) through (iv), 558.633 Added ...... 36790 (2)(i) through (xiii) and (3)(i) (d)(1) revised ...... 67153 through (iv) amended...... 48703 558.635 Revised ...... 95022

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21 CFR—Continued 81 FR 21 CFR—Continued 82 FR Page Page Chapter I—Continued Chapter I—Continued 558.665 (e)(2) through (6), (8), (10), 520.304 (b)(1) and (2) revised; (b)(3) (11) and (12) amended...... 48703 removed ...... 43484 (e)(5), (6), (11) and (12) removed; 520.370 (c)(2) amended ...... 12169 (f) added ...... 95025 520.540c (b) amended ...... 11508 558.680 (d)(1)(ii), (iii), (iv), (vi), 520.955 (b) revised...... 12169 (vii), (viii) and (2)(ii) amend- 520.980 (b) amended ...... 21690 ed ...... 17609 520.1189 Added ...... 12169 (d)(1)(x) removed; (e)(3) added...... 95025 520.1445 (c)(1)(ii) revised...... 58556 570.3 (f), (h) and (k) revised; (i) 520.1454 (b) amended...... 21690 amended; (n) added ...... 55051 520.2041 (b) amended...... 12169 Regulation at 81 FR 55051 eff. 520.2086 (c)(2) revised ...... 12169 date corrected...... 62004 520.2325b (b) amended...... 12169 570.30 (a) and (i) amended; (b), (c) 522 Drug application approvals and (d) revised...... 55052 withdrawn...... 12170, 21694 Regulation at 81 FR 55052 eff. 522.90b (a) amended...... 21690 date corrected...... 62004 522.304 (b) revised...... 43484 570.35 (a), (b)(1), (3) and (4) revised; 522.313c (b) amended ...... 12169 (c) removed...... 55052 522.540 (d)(2)(i) amended...... 11508 Regulation at 81 FR 55052 eff. 522.970 (b)(1) revised; (b)(3), date corrected...... 62004 (e)(2)(ii)(B) and (iii) removed; 570.38 (a) revised ...... 55052 (e)(2)(ii) amended...... 43484 Regulation at 81 FR 55052 eff. 522.1002 (b) removed; (c) redesig- date corrected...... 62004 nated as new (b)...... 21690 570.203—570.280 (Subpart E) (b)(1) revised ...... 43484 Added ...... 55052 522.1055 (b) amended...... 11508, 21690 Regulation at 81 FR 55052 eff. 522.1182 (b)(3) amended...... 11508 date corrected...... 62004 522.1335 (b) amended...... 58556 573.304 Added ...... 35611 522.1362 (b) amended...... 21690 Regulation at 81 FR 35611 eff. 522.1380 (b) amended ...... 11508 date confirmed; comment pe- 522.1450 (b) amended...... 21690 riod extended ...... 41441 522.1660a (e)(1)(ii) amended ...... 43484 573.496 Added ...... 86269 522.1662a (e)(1) revised; (e)(3)(i)(c) 573.696 Added ...... 67154 amended...... 21690 Introductory text and (b) revised 522.2075 (c) revised ...... 12170 ...... 95027 522.2470 (b), (c)(1)(i), (ii), and (2) 589.2001 (b)(1)(vi)(B) amended ...... 5596 revised ...... 58556 522.2473 (b) amended...... 21691 2017 522.2477 (b)(2) revised; (d)(4) added...... 21691 21 CFR 82 FR (b)(2) revised; (d)(1)(iii) through Page (4)(iii) amended; (d)(5) added...... 43484 Chapter I 522.2615 (b) amended...... 11508 507 Policy statement ...... 51345 524 Drug application approvals 507.75 Revised ...... 14147 withdrawn...... 11509 510 Drug application approvals 524.998 (c)(2) added ...... 43485 withdrawn...... 12170 524.1005 (b)(1) amended...... 11508 510.600 (c)(1) table and (2) table 524.1450 (b)(1) amended...... 21691 amended...... 11508, 12168, 21690, 43484, 524.1465 (b) amended...... 11508 58555 524.1580a (d)(3) amended...... 58556 511.1 Heading and (c)(6) revised; 529 Drug application approvals (c)(1) and (2) amended; (c)(1)(i), withdrawn...... 12170 (ii), (2)(i) and (ii) added ...... 61446 529.1030 (d)(1)(ii), (2)(iii), and (3) 516.2065 Added ...... 12169 revised; (d)(2)(i) table and (ii) 520.48 (b) amended...... 21690 table amended ...... 58556 520.88g (b) amended...... 11508 529.1186 (b) amended...... 12170 (c)(1)(ii) and (2)(ii) amended...... 43484 558 Drug application approvals Heading, (a), and (b) revised...... 58556 withdrawn...... 11509

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21 CFR—Continued 82 FR 21 CFR—Continued 82 FR Page Page Chapter I—Continued Chapter I—Continued 558.4 (d) table amended ...... 21691, 43485 573.492 Added ...... 38596 558.58 (f)(4) and (5) removed ...... 58557 558.68 (e)(1)(ii) revised...... 11509 558.76 (e)(1)(vii) removed...... 21691 2018 558.115 (d)(4) revised...... 21691 (Regulations published from January 1, 558.128 (b)(1), (e)(1)(i), (v), (3)(v), 2018, through April 1, 2018) (4)(iii) amended; (e)(4)(xxiv) and (xxv) redesignated as 21 CFR 83 FR (e)(4)(xxv) and (xxvi); new Page (e)(4)(xxiv) added ...... 21691 Chapter I (e)(4)(iii), (xi), (xii), (xiii), (5)(ii), 507 Policy statement ...... 598 (iii) and (6)(v) amended...... 43485 510.600 (c)(1) table and (2) table 558.140 (b)(1) amended ...... 21691 amended...... 13634 558.325 (e)(1)(ii) revised ...... 12170 (e)(2)(vii) and (viii) redesignated (c)(1) table and (2) table amend- as (xvi) and (xvii); new ed; eff. 4-9-18 ...... 13635 (e)(2)(vii) added ...... 21691 520.48 (b) amended...... 13635 558.366 (e) revised...... 21692 520.1447 (d)(1)(ii) amended...... 13635 (e) removed ...... 58557 520.2645 (d)(1) and (2) revised...... 13635 558.450 (e)(4)(iii) redesignated as 522 Drug application approval (e)(4)(v); new (e)(4)(iii) and (iv) withdrawn...... 13637 added...... 11512 522.300 Removed; eff. 4-9-18...... 13635 558.485 (e)(1)(iv) removed ...... 21692 522.540 (b)(2) and (c)(2) revised; 558.550 (d)(5) added ...... 21692 eff. 4-9-18...... 13635 558.625 (d)(2) revised; (d)(4) and (5) added; (e)(2)(iv), (v), (vi), (vii), 522.1081 (b)(1) amended; eff. 4-9- (viii), (ix), (x), (xi), (xii), (xiii), 18...... 13635 (xiv) and (xv) amended ...... 21692 522.1662a (h)(3)(ii) amended...... 13635 (e)(1)(vii), (ix), (2)(ii), (iii), (vi) 522.1680 (b) amended...... 13635 through (xv) amended ...... 43485 524.970 Added ...... 13635 558.635 (a) and (e) revised; (d)(1) 524.1132 (a) revised ...... 13635 and (2) added ...... 11512 524.1193 (b)(2) amended...... 13635 (e)(1) revised ...... 21692 556.286 (c) amended ...... 13635 558.680 (e) removed; (d)(3) 558.4 (d) table amended ...... 13635 added...... 21693 558.128 (e)(3) table and (4) table 573.170 (c) and (d) redesignated as amended...... 13636 (d) and (e); new (c) and new (d)(3) added; new (e) introduc- 558.325 (d)(2) revised...... 13637 tory text revised ...... 52209 558.575 (e)(2)(ii) amended...... 13637 573.480 (b)(3) and (4) redesignated 573.480 (b) introductory text and as (b)(4) and (5); new (b)(3) and (5)(iii)(B) revised...... 20 (b)(4)(iii) added; new (b)(5) in- 573.940 (d) and (e) added...... 8930 troductory text revised...... 52209 Æ

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