Title 21 Food and Drugs Part 500 to 599

Revised as of April 1, 2014

Containing a codification of documents of general applicability and future effect

As of April 1, 2014

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 Printing Office Official Edi- tions only. The Superintendent of Documents of the U.S. Govern- ment Printing Office requests that any reprinted edition clearly be labeled as a copy of the authentic work with a new ISBN.

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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 ...... 549

Alphabetical List of Agencies Appearing in the CFR ...... 569

List of CFR Sections Affected ...... 579

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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, 2014), 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 Mar<15>2010 09:09 Aug 04, 2014 Jkt 232075 PO 00000 Frm 00005 Fmt 8008 Sfmt 8092 Y:\SGML\232075.XXX 232075 wreier-aviles on DSK5TPTVN1PROD with CFR 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 Mar<15>2010 09:09 Aug 04, 2014 Jkt 232075 PO 00000 Frm 00006 Fmt 8008 Sfmt 8092 Y:\SGML\232075.XXX 232075 wreier-aviles on DSK5TPTVN1PROD with CFR 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 Printing 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 Printing 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 Printing 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 Printing Office. It is available at www.ecfr.gov.

CHARLES A. BARTH, Director, Office of the Federal Register. April 1, 2014.

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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, 2014.

For this volume, Michele Bugenhagen was Chief Editor. The Code of Federal Regulations publication program is under the direction of the Managing Editor, assisted by Ann Worley.

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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 ...... 32 509 Unavoidable contaminants in animal food and food-packaging material ...... 34 510 New animal drugs ...... 38 511 New animal drugs for investigational use ...... 48 514 New animal drug applications ...... 53 515 Medicated feed mill license ...... 89 516 New animal drugs for minor use and minor species 93 520 Oral dosage form new animal drugs ...... 118 522 Implantation or injectable dosage form new animal drugs ...... 240 524 Ophthalmic and topical dosage form new animal drugs ...... 318 526 Intramammary dosage form new animal drugs ...... 342 528 New animal drugs in genetically engineered animals ...... 348 529 Certain other dosage form new animal drugs ...... 348 530 Extralabel drug use in animals ...... 354 556 Tolerances for residues of new animal drugs in food 360 558 New animal drugs for use in animal feeds ...... 374 564 [Reserved] 570 Food additives...... 479 571 Food additive petitions ...... 487 573 Food additives permitted in feed and drinking water of animals ...... 492

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Part Page 579 Irradiation in the production, processing, and handling of animal feed and pet food ...... 512 582 Substances generally recognized as safe ...... 513 584 Food substances affirmed as generally recognized as safe in feed and drinking water of animals ...... 538 589 Substances prohibited from use in animal food or feed ...... 539 590–599 [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 Used in Food-Producing Animals Subpart B—Specific Administrative Rulings 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 ani- Subpart A [Reserved] mals. 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. The provisions of part 113 of this 500.46 Hexachlorophene in animal drugs. chapter shall apply to the manufac- 500.50 Propylene glycol in or on cat food. ture, processing or packing of low-acid foods in hermetically sealed con- Subpart C—Animal Drug Labeling tainers, and intended for use as food for Requirements animals. 500.51 Labeling of animal drugs; mis- [61 FR 37681, July 19, 1996] branding. 500.52 Use of terms such as ‘‘tonic’’, ‘‘tone’’, § 500.24 Emergency permit control. ‘‘toner’’, or ‘‘conditioner’’ in the labeling The provisions of part 108 of this of preparations intended for use in or on chapter shall apply to the issuance of animals. emergency control permits for the 500.55 Exemption from certain drug-labeling manufacturer or packer of thermally requirements. processed low-acid foods packaged in Subpart D—Requirements for Specific hermetically sealed containers, and in- Animal Drugs tended for use as food for animals. [61 FR 37681, July 19, 1996] 500.65 Epinephrine injection 1:1,000 in 10- milliliter containers for emergency § 500.25 Anthelmintic drugs for use in treatment of anaphylactoid shock in cat- animals. tle, horses, sheep, and swine. (a) The Commissioner of Food and Subpart E—Regulation of Carcinogenic Drugs has determined that, in order to Compounds Used in Food-Producing assure that anthelmintic drugs, includ- Animals ing animal feeds bearing or containing such drugs, which do not carry the pre- 500.80 Scope of this subpart. scription statement are labeled to pro- 500.82 Definitions. vide adequate directions for their effec- 500.84 Conditions for approval of the spon- tive use, labeling of these anthelmintic sored compound. drugs shall bear, in addition to other 500.86 Marker residue and target tissue. required information, a statement that 500.88 Regulatory method. a veterinarian should be consulted for 500.90 Waiver of requirements. assistance in the diagnosis, treatment, and control of parasitism.

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(b) The label and any labeling fur- index, as required by paragraph (a) of nishing or purporting to furnish direc- this section. tions for use, shall bear conspicuously (c) The fact that the labeling of this the following statement: ‘‘Consult your kind of drug may claim delayed, pro- veterinarian for assistance in the diag- longed, controlled, or sustained-release nosis, treatment, and control of para- of all or only some of the active ingre- sitism.’’ dients does not affect the new animal (c) For drugs covered by approved drug status of such articles. A new ani- new animal drug applications, the la- mal drug application or index listing is beling revisions required for compli- required in any such case. ance with this section may be placed (d) New animal drug applications for into effect without prior approval, as timed-release dosage form animal provided for in § 514.8(c)(3) of this chap- drugs must contain, among other ter. For drugs listed in the index, the things, data to demonstrate safety and labeling revisions required for compli- effectiveness by establishing that the ance with this section may be placed article is manufactured using proce- into effect without prior granting of a dures and controls to ensure release of request for a modification, as provided the total dosage at a safe and effective for in § 516.161(b)(1) of this chapter. rate. Data submitted in the new animal (d) Labeling revisions required for drug application must demonstrate compliance with this section shall be that the formulation of the drug and placed into effect by February 25, 1975, the procedures used in its manufacture following which, any such drugs that will ensure release of the active ingre- are introduced into interstate com- dient(s) of the drug at a safe and effec- merce and not in compliance with this tive rate and that these release charac- section will be subject to regulatory teristics will be maintained until the proceedings. expiration date of the drug. When the [40 FR 13802, Mar. 27, 1975, as amended at 71 drug is intended for use in food-pro- FR 74782, Dec. 13, 2006; 72 FR 69120, Dec. 6, ducing animals, data submitted must 2007] also demonstrate that, with respect to possible residues of the drug, food de- § 500.26 Timed-release dosage form rived from treated animals is safe for drugs. consumption. (a) Drugs are being offered in dosage forms that are designed to release the [42 FR 8635, Feb. 11, 1977, as amended at 60 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 unsafe overdosage or ineffective dosage § 500.27 Methylene blue-containing if such products are improperly made drugs for use in animals. and the active ingredients are released at one time, over too short or too long (a) New information requires a re- a period of time, or not released at all. evaluation of the status of drugs con- Drugs marketed in this form, which are taining methylene blue referred to by such terms as timed-re- (tetramethylthionine chloride) for oral lease, controlled-release, prolonged-re- use in cats or dogs. lease, sustained-release, or delayed-re- (1)(i) It has been demonstrated that lease drugs, are regarded as new animal two orally administered urinary anti- drugs within the meaning of section septic-antispasmodic preparations that 201(v) of the Federal Food, Drug, and contained methylene blue cause Heinz Cosmetic Act. body hemolytic anemia in cats when (b) Timed-release dosage form animal used according to label directions. The drugs that are introduced into inter- specific cause of the reaction was de- state commerce are deemed to be adul- termined to be the methylene blue con- terated within the meaning of section tained in the preparations. The reac- 501(a)(5) of the act and subject to regu- tion can be severe enough to cause latory action, unless such animal drug death of treated animals. is the subject of an approved new ani- (ii) The Heinz body hemolytic anemia mal drug application, or listed in the 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 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 AB Science, 3 Avenue George V, 75008 Paris, France ...... 052913 Abbott Laboratories, North Chicago, IL 60064 ...... 000044 Accord Healthcare, Inc., 1009 Slater Rd., suite 210–B, Durham, NC 27703 ...... 016729 ADM Alliance 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 Alaco, Inc., 1500 North Wilmot Rd., suite 290–C, Tucson, AZ 85712 ...... 064146 Alpharma, LLC, a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017 ...... 046573 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 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 B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756 ...... 067188 Baxter Healthcare Corp., One Baxter Pkwy., Deerfield, IL 60015...... 010019 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 Bioniche Animal Health USA, Inc., 119 Rowe Rd., Athens, GA 30601 ...... 064847 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 ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, NE 68105 ...... 021091 Contemporary Products, Inc., 3788 Elm Springs Rd., Springdale, AR 72764–6067 ...... 055462 Cooperative Research Farms, Box 69, Charlotteville, NY 12036 ...... 051267 Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland ...... 061623 Dechra, Ltd., Dechra House, Jamage Industrial Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW, United Kingdom ...... 043264 ECO LLC, 344 Nassau St., Princeton, NJ 08540 ...... 066916 Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285 ...... 000986 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 Fort Dodge Animal Health, Division of Wyeth, a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017 ...... 000856 Fort Dodge Animal Health, Division of Wyeth Holdings Corp., a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017 ...... 053501 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 Gossett Nutrition, Inc., 1676 Cascade Dr., Marion, OH 43302 ...... 050972 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 Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525 ...... 063604 Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY 40511 ...... 050749 Hikma Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118 ...... 059115 Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045 ...... 000409 HQ Specialty Pharma Corp., 120 Rte. 17 North, Suite 130, Paramus, NJ 07652 ...... 042791 Huvepharma AD, 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 International Nutrition, Inc., 7706 ‘I’ Plaza, Omaha, NE 68127 ...... 043733 Intervet, Inc., 556 Morris Ave., Summit, NJ 07901 ...... 000061 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 Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601 ...... 061690 Luitpold Pharmaceuticals, Inc., Animal Health Division, Shirley, NY 11967 ...... 010797 Macleod Pharmaceuticals, Inc., 2600 Canton Ct., Fort Collins, CO 80525 ...... 058711 Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767–1861 ...... 054925 Medicis Dermatologics, Inc., 8125 North Hayden Rd., Scottsdale, AZ 85258 ...... 099207 Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096–4640...... 050604 Micro Beef Technologies LTD, P.O. Box 9262, Amarillo, TX 79105 ...... 047126 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 Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland ...... 055529 Novartis Animal Health US, Inc., 3200 Northline Ave., suite 300, Greensboro, NC 27408 ...... 058198 NutriBasics Co., North Highway 71, P.O. Box 1014, WIllmar, MN 56201 ...... 053740

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(1) ALPHABETICAL LISTING OF SPONSORS—Continued

Drug labeler Firm name and address code

Oasmia Pharmaceutical AB, Vallongatan 1, 75228 Uppsala, Sweden ...... 052818 Orion Corp., Orionintie 1, 02200 Espoo, Finland ...... 052483 OPK Biotech, LLC, 11 and 39 Hurley St., Cambridge, MA 02141 ...... 063075 OXIS International, Inc., 6040 N. Cutter Circle, Suite 317, Portland, OR 97217–3935 ...... 024991 Paladin Labs (USA), Inc., 160 Greentree Dr., suite 101, Dover, DE 19904 ...... 046129 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 Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144 ...... 048164 Pfizer, Inc., 235 East 42d St., New York, NY 10017 ...... 000069 Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona, NY 10970 ...... 050057 Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017 ...... 000009 Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ 07069 ...... 042552 Pharmaq AS, Skogmo Industriomrade, N–7863 Overhalla, Norway...... 015331 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 Provimi North America, Inc., 6531 State Rte. 503, Lewisburg, OH 45338 ...... 017790 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 Seeco Inc., Box 1014, North Highway 71, Willmar, MN 56201 ...... 011749 Sioux Biochemical, Inc., 204 Third St. NW., Sioux Center, IA 51250 ...... 063112 SmartVet USA, Inc., 22201 West Innovation Dr., Suite 170A, Olathe, KS 66061–1304 ...... 086001 Sogeval S.A., 200 Avenue de Mayenne, 53000 Laval, France ...... 059120 Southern Micro-Blenders, Inc., 3801 North Hawthorne St., Chattanooga, TN 37406 ...... 049685 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 Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532 ...... 051672 Teva Canada Ltd., 30 Novopharm Ct., Toronto, Ontario, Canada M1B 2K9 ...... 043806 Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503 ...... 052923 Thorn Bioscience LLC, 1044 East Chestnut St., Louisville, KY 40204 ...... 051330 Veterinary Service, Inc., 4100 Bangs Ave., Modesto, CA 95356 ...... 033008 Ve´toquinol N.–A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5 ...... 059320 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 Wayne Feed Division, Continental Grain Co., P.O. Box 459, Libertyville, IL 60048 ...... 034936 Wellmark International, 1501 East Woodfield Rd., suite 200 West, Schaumburg, IL 60173 ...... 011536 Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA 98248 ...... 050378 Wildlife Laboratories, Inc., 1401 Duff Dr., Suite 600, Fort Collins, CO 80524 ...... 053923 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 ...... 054771

(2) NUMERICAL LISTING OF SPONSORS

Drug labeler code Firm name and address

000008 Wyeth Laboratories, Division American Home Products Corp., P.O. Box 8299, Philadelphia, PA 19101. 000009 Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017. 000010 Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506–2002. 000044 Abbott Laboratories, North Chicago, IL 60064 000061 Intervet, Inc., 556 Morris Ave., Summit, NJ 07901. 000069 Pfizer, Inc., 235 East 42d St., New York, NY 10017. 000115 IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544 000402 Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880. 000409 Hospira Inc., 275 North Field Dr., Lake Forest, IL 60045. 000856 Fort Dodge Animal Health, Division of Wyeth, a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017 000859 Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201. 000986 Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285. 010019 Baxter Healthcare Corp., One Baxter Pkwy., Deerfield, IL 60015. 010515 G. C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 13201.

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(2) NUMERICAL LISTING OF SPONSORS—Continued

Drug labeler code Firm name and address

010797 Luitpold Pharmaceuticals, Inc., Animal Health Division, Shirley, NY 11967. 011536 Wellmark International, 1501 East Woodfield Rd., suite 200 West, Schaumburg, IL 60173. 012164 Halocarbon Products Corp., 887 Kinderkamack Rd., River Edge, NJ 07661. 012286 ADM Alliance 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. 016592 Huvepharma AD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria. 016729 Accord Healthcare, Inc., 1009 Slater Rd., suite 210–B, Durham, NC 27703 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. 017790 Provimi North America, Inc., 6531 State Rte. 503, Lewisburg, OH 45338. 017800 Purina Animal Nutrition, 1080 County Road F West, Shoreview, MN 55126–2910. 021091 ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, NE 68105. 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. 033008 Veterinary Service, Inc., 4100 Bangs Ave., Modesto, CA 95356. 034936 Wayne Feed Division, Continental Grain Co., P.O. Box 459, Libertyville, IL 60048. 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., Dechra House, Jamage Industrial Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW, United Kingdom. 043733 International Nutrition, Inc., 7706 ‘I’ Plaza, Omaha, NE 68127. 043806 Teva Canada Ltd., 30 Novopharm Ct., Toronto, Ontario, Canada M1B 2K9. 046129 Paladin Labs (USA), Inc., 160 Greentree Dr., suite 101, Dover, DE 19904. 046573 Alpharma, LLC, a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017 047126 Micro Beef Technologies LTD, P.O. Box 9262, Amarillo, TX 79105. 048164 Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144. 049185 Walco International, Inc., 15 West Putnam, Porterville, CA 93257. 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 Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA 98248. 050604 Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096–4640. 050749 Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY 40511. 050972 Gossett Nutrition, Inc., 1676 Cascade Dr., Marion, OH 43302. 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. 052913 AB Science, 3 Avenue George V, 75008 Paris, France. 052923 Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503 053501 Fort Dodge Animal Health, Division of Wyeth Holdings Corp., a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017 053923 Wildlife Laboratories, Inc., 1401 Duff Dr., Suite 600, Fort Collins, CO 80524. 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. 055462 Contemporary Products, Inc., 3788 Elm Springs Rd., Springdale, AR 72764–6067. 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 Novartis Animal Health US, Inc., 3200 Northline Ave., suite 300, Greensboro, NC 27408. 058670 RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620. 058711 Macleod Pharmaceuticals, Inc., 2600 Canton Ct., Fort Collins, CO 80525. 058829 First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123. 059115 Hikma Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118.

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(2) NUMERICAL LISTING OF SPONSORS—Continued

Drug labeler code Firm name and address

059120 Sogeval S.A., 200 Avenue de Mayenne, 53000 Laval, France. 059320 Ve´toquinol N.–A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5. 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 OPK Biotech, LLC, 11 and 39 Hurley St., Cambridge, MA 02141 063112 Sioux Biochemical, Inc., 204 Third St. NW., Sioux Center, IA 51250. 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. 064847 Bioniche Animal Health USA, Inc., 119 Rowe Rd., Athens, GA 30601. 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 076175 Ark Sciences, Inc., 1101 East 33rd St., suite B304, Baltimore, MD 21218. 076475 Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349 086001 SmartVet USA, Inc., 22201 West Innovation Dr., Suite 170A, Olathe, KS 66061–1304 099207 Medicis Dermatologics, Inc., 8125 North Hayden Rd., Scottsdale, AZ 85258.

[40 FR 13807, Mar. 27, 1975]

EDITORIAL NOTE: 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.

EDITORIAL NOTE: At 72 FR 36595, July 5, 2007, § 510.600, in the table in paragraph (c)(2), was amended by removing the entry for ‘‘062749’’; however, the amendment could not be incorporated because the entry does not exist.

EDITORIAL NOTE: 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’’ doesn’t exist.

PART 511—NEW ANIMAL DRUGS animal drug or animal feed bearing or FOR INVESTIGATIONAL USE containing a new animal drug intended solely for tests in vitro or in animals Sec. used only for laboratory research pur- 511.1 New animal drugs for investigational poses shall be exempt from section 512 use exempt from section 512(a) of the act. (a) and (m) of the act if it is labeled as 511.3 Definitions. follows:

AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 360b, Caution. Contains a new animal drug for 371. investigational use only in laboratory research animals or for tests in vitro. Not for § 511.1 New animal drugs for inves- use in humans. tigational use exempt from section 512(a) of the act. (2) The person distributing or causing the distribution of new animal drugs (a) New animal drugs for tests in vitro for tests in vitro or in animals used and in laboratory research animals. (1) A shipment or other delivery of a new only for laboratory research purposes

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under this exemption shall use due dili- in the package from which the new ani- gence to assure that the consignee is mal drug is to be dispensed. regularly engaged in conducting such (2) The person or firm distributing or tests and that the shipment of the new causing the distribution of the new ani- animal drug will actually be used for mal drug or animal feed containing a tests in vitro or in animals used only new animal drug shall use due dili- for laboratory research. gence to assure that the new animal (3) The person who introduced such drug or animal feed containing a new shipment or who delivered the new ani- animal drug will actually be used for mal drug for introduction into inter- tests in animals and is not used in hu- state commerce shall maintain ade- mans. quate records showing the name and (3) The person who introduced such post office address of the expert or ex- shipment or who delivered the new ani- pert organization to whom the new animal drug or animal feed containing a mal drug is shipped and the date, quan- new animal drug for introduction into tity, and batch or code mark of each interstate commerce shall maintain shipment and delivery for a period of 2 adequate records showing the name years after such shipment and delivery. and post office address of the investi- Upon the request of a properly author- gator to whom the new animal drug or ized employee of the Department at animal feed containing a new animal reasonable times, he shall make such drug is shipped and the date, quantity, records available for inspection and and batch or code mark of each ship- copying. ment and delivery for a period of 2 (4) The exemption allowed in this years after such shipment and delivery. paragraph shall not apply to any new Upon the request of a properly author- animal drug intended for in vitro use in ized employee of the Department at the regular course of diagnosing or reasonable times, such records shall be treating disease, including anti- made available for inspection and bacterial sensitivity discs impregnated copying. with any new animal drug or drugs, (4) Prior to shipment of the new ani- which discs are intended for use in de- mal drug for clinical tests in animals, termining susceptibility of microorga- the sponsor of the investigation shall nisms to the new animal drug or drugs. submit in triplicate to FDA a ‘‘Notice (b) New animal drugs for clinical inves- of Claimed Investigational Exemption tigation in animals. A shipment or other for a New Animal Drug’’ including a delivery of a new animal drug or an signed statement containing the fol- animal feed containing a new animal lowing information: drug intended for clinical investiga- (i) The identity of the new animal tional use in animals shall be exempt drug. from section 512(a) and (m) of the act if (ii) All labeling and other pertinent all the following conditions are met: information to be supplied to the inves- (1) The label shall bear the state- tigators. When such pertinent informa- ments: tion includes nonclinical laboratory studies, the information shall include, Caution. Contains a new animal drug for use only in investigational animals in clin- with respect to each nonclinical study, ical trials. Not for use in humans. Edible either a statement that the study was products of investigational animals are not conducted in compliance with the re- to be used for food unless authorization has quirements set forth in part 58 of this been granted by the U.S. Food and Drug Ad- chapter, or, if the study was not con- ministration or by the U.S. Department of ducted in compliance with such regula- Agriculture. tions, a brief statement of the reason In the case of containers too small or for the noncompliance. otherwise unable to accommodate a (iii) The name and address of each label with sufficient space to bear the clinical investigator. caution statements required by para- (iv) The approximate number of ani- graph (a) or (b) of this section, the mals to be treated (or if not available, statements may be included on the car- the amount of new animal drug to be ton label and other labeling on or with- shipped).

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(v) If the new animal drug is given to (b)(4)(v)(c) of this section, will not be food-producing animals, the statement inconsistent with the public health; or shall contain the following additional (ii) Data to show that food derived information: from animals treated at the maximum (a) A commitment that the edible levels and with the minimum with- products from such animals shall not drawal periods, if any, specified in ac- be used for food without prior author- cordance with paragraph (b)(4)(v)(c) of ization in accordance with the provi- this section, does not contain drug res- sions prescribed in this section. idues or metabolites. (b) Approximate dates of the begin- (iii) The name and location of the ning and end of the experiment or se- packing plant where the animals will ries of experiments. be processed, except that this require- (c) The maximum daily dose(s) to be ment may be waived, on request, by administered to a given species, the the terms of the authorization. size of animal, maximum duration of Authorizations granted under this administration, method(s) of adminis- paragraph do not exempt investiga- tration, and proposed withdrawal time, tional animals and their products from if any. compliance with other applicable in- (vi) If a sponsor has transferred any spection requirements. Any person who obligations for the conduct of any clin- contests a refusal to grant such au- ical study to a contract research orga- thorization shall have an opportunity nization, a statement containing the for a regulatory hearing before FDA name and address of the contract re- pursuant to part 16 of this chapter. search organization, identification of (6) On written request of FDA, the the clinical study, and a listing of the sponsor shall submit any additional in- obligations transferred. If all obliga- formation reported to or otherwise re- tions governing the conduct of the ceived by him with respect to the in- study have been transferred, a general vestigation deemed necessary to facili- statement of this transfer—in lieu of a tate a determination whether there are listing of the specific obligations trans- grounds in the interest of public health ferred—may be submitted. for terminating the exemption. (5) Authorization for use of edible products derived from a treated food- (7) The sponsor shall assure himself producing animal may be granted that the new animal drug is shipped under the provisions of this section and only to investigators who: when the following specified conditions (i) Are qualified by scientific training are met, except that in the case of an and/experience to evaluate the safety animal administered any unlicensed and/or effectiveness of the new animal experimental veterinary biological drug. product regulated under the viruses, (ii) Shall maintain complete records serums, toxins statute (21 U.S.C., chap- of the investigations, including com- ter V, sec. 151 et seq. ) the product shall plete records of the receipt and disposi- be exempt from the requirements of tion of each shipment or delivery of the this section when U.S. Department of new animal drug under investigation. Agriculture approval has been obtained Copies of all records of the investiga- as provided in 9 CFR 103.2. Conditional tion shall be retained by the investi- authorization may be granted in ad- gator for 2 years after the termination vance of identification of the name(s) of the investigation or approval of a and address(es) of the clinical investi- new animal drug application. gator(s) as required by paragraph (iii) Shall furnish adequate and time- (b)(4)(iii) of this section. Information ly reports of the investigation to the required for authorization shall in- sponsor. clude, in addition to all other require- (8) The sponsor: ments of this section, the following: (i) Shall retain all reports received (i) Data to show that consumption of from investigators for 2 years after the food derived from animals treated at termination of the investigation or ap- the maximum levels with the min- proval of a new animal drug applica- imum withdrawal periods, if any, speci- tion and make such reports available fied in accordance with paragraph to a duly authorized employee of the

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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 perience to evaluate information ob- the conditions of these exempting regu- tained from the investigation, and lations or has repeatedly or delib- shall promptly investigate and report erately submitted to FDA or to the to FDA and to all investigators any sponsor false information in any re- findings associated with use of the new quired report, the Center for Veteri- animal drug that may suggest signifi- nary Medicine will furnish the investi- cant hazards pertinent to the safety of gator written notice of the matter the new animal drug. complained of and offer the investi- (iii) Shall not unduly prolong dis- gator an opportunity to explain the tribution of the new animal drug for matter in writing, or, at the option of investigational use. the investigator, in an informal con- (iv) Shall not, nor shall any person ference. If an explanation is offered and acting for or on behalf of the sponsor, accepted by the Center for Veterinary represent that the new animal drug is Medicine, the Center will discontinue safe or effective for the purposes for the disqualification proceeding. If an which it is under investigation. This explanation is offered but not accepted requirement is not intended to restrict by the Center for Veterinary Medicine, the full exchange of scientific informa- the investigator will be given an oppor- tion. tunity for a regulatory hearing under (v) Shall not commercially distribute part 16 of this chapter on the question nor test-market the new animal drug of whether the investigator is eligible until a new animal drug application is to receive test articles under this part approved pursuant to section 512(c) of and eligible to conduct any clinical in- the act. vestigation that supports an applica- (9) If the shipment or other delivery tion for a research or marketing per- of the new animal drug is imported or mit for products regulated by FDA. offered for importation into the United (2) After evaluating all available in- States for clinical investigational use formation, including any explanation in animals, it shall also meet the fol- presented by the investigator, if the lowing conditions: Commissioner determines that the in- (i) The importer of all such ship- vestigator has repeatedly or delib- ments or deliveries is an agent of the erately failed to comply with the con- foreign exporter residing in the United ditions of the exempting regulations in States or the ultimate consignee, this subchapter, or has repeatedly or which person has, prior to such ship- deliberately submitted to FDA or to ments and deliveries, informed FDA of the sponsor false information in any his intention to import the new animal required report, the Commissioner will drug as sponsor in compliance with the notify the investigator and the sponsor conditions prescribed in this subdivi- of any investigation in which the in- sion; or vestigator has been named as a partici- (ii) The new animal drug is shipped pant that the investigator is not eligi- directly to a scientific institution with ble to receive test articles under this adequate facilities and qualified per- part. The notification to the investi- sonnel to conduct laboratory or clin- gator and sponsor will provide a state- ical investigations and is intended ment of the basis for such determina- solely for use in such institutions and tion. The notification also will explain which institution has submitted a that an investigator determined to be statement as sponsor of the investiga- ineligible to receive test articles under tion. this part will be ineligible to conduct (10) The sponsor shall submit either a any clinical investigation that sup- claim for categorical exclusion under ports an application for a research or § 25.30 or § 25.33 of this chapter or an en- marketing permit for products regu- vironmental assessment under § 25.40 of lated by FDA, including drugs, bio- this chapter. logics, devices, new animal drugs,

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foods, including dietary supplements, has presented adequate assurances that that bear a nutrient content claim or a the investigator will employ all test health claim, infant formulas, food and articles, and will conduct any clinical color additives, and tobacco products. investigation that supports an applica- (3) Each application or submission to tion for a research or marketing per- FDA under the provisions of this chap- mit for products regulated by FDA, ter containing data reported by an in- solely in compliance with the applica- vestigator who has been determined to ble provisions of this chapter. be ineligible to receive FDA-regulated (d) Termination of exemption. If the test articles is subject to examination Commissioner finds that: to determine whether the investigator (1) The sponsor of the investigation has submitted unreliable data that are has failed to comply with any of the essential to the continuation of an in- conditions for the exemption estab- vestigation or essential to the approval lished under this section, or of a marketing application, or essen- (2) The continuance of the investiga- tial to the continued marketing of an tion is unsafe or otherwise contrary to FDA-regulated product. the public interest or the drug is being (4) If the Commissioner determines, or has been used for purposes other after the unreliable data submitted by than bona fide scientific investigation, the investigator are eliminated from he shall first notify the sponsor and in- consideration, that the data remaining vite his immediate correction. If the are inadequate to support a conclusion conditions of the exemption are not that it is reasonably safe to continue immediately met, the sponsor shall the investigation, the Commissioner have an opportunity for a regulatory will notify the sponsor, who shall have hearing before FDA pursuant of part 16 an opportunity for a regulatory hear- of this chapter on whether the exemp- ing under part 16 of this chapter. If a tion should be terminated. If the ex- danger to the public health exists, how- emption is terminated the sponsor ever, the Commissioner shall termi- shall recall or have destroyed the un- nate the exemption immediately and notify the sponsor of the termination. used supplies of the new animal drug. In such case, the sponsor shall have an (e) Statements and requests. ‘‘Notice(s) opportunity for a regulatory hearing of Claimed Investigational Exemption before FDA under part 16 on the ques- for a New Animal Drug’’ and requests tion of whether the exemption should for authorization to use investigational be reinstated. The determination that animals and their products for food an investigation may not be considered should be addressed to the Department in support of a research or marketing of Health and Human Services, Food application or a notification or peti- and Drug Administration, Center for tion submission does not, however, re- Veterinary Medicine, 7500 Standish Pl., lieve the sponsor of any obligation Rockville, MD 20855. under any other applicable regulation (f) Contract research organizations. (1) to submit to FDA the results of the in- For purposes of this part and part 514, vestigation. contract research organization means a (5) If the Commissioner determines, person that assumes, as an independent after the unreliable data submitted by contractor with the sponsor, one or the investigator are eliminated from more of the obligations of a sponsor, consideration, that the continued ap- e.g., design of a protocol, selection or proval of the product for which the monitoring of investigations, evalua- data were submitted cannot be justi- tion of reports, and preparation of ma- fied, the Commissioner will proceed to terials to be submitted to FDA. withdraw approval of the product in ac- (2) A sponsor may transfer responsi- cordance with the applicable provisions bility for any or all of the obligations of the relevant statutes. set forth in this part to a contract re- (6) An investigator who has been de- search organization. Any such transfer termined to be ineligible under para- shall be in writing and, if not all obli- graph (c)(2) of this section may be rein- gations are transferred, shall describe stated as eligible when the Commis- each of the obligations being assumed sioner determines that the investigator by the contract research organization.

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If all obligations are transferred, a gen- governmental agency, academic insti- eral statement that all obligations tution, private organization, or other have been transferred is acceptable. organization. The sponsor does not ac- Any obligation not covered by the tually conduct the investigation unless written description shall be deemed not the sponsor is a sponsor-investigator. A to have been transferred. person other than an individual that (3) A contract research organization uses one or more of its own employees that assumes any obligation of a spon- to conduct an investigation that it has sor shall comply with the specific regu- initiated is a sponsor, not a sponsor-in- lations in this chapter applicable to vestigator, and the employees are in- this obligation and shall be subject to vestigators. the same regulatory action as a spon- Sponsor-Investigator means an indi- sor for failure to comply with any obli- vidual who both initiates and conducts gation assumed under these regula- an investigation, and under whose im- tions. Thus, all references to sponsor in mediate direction the investigational this part apply to a contract research drug is administered or dispensed. The organization to the extent that it as- term does not include any person other sumes one or more obligations of the than an individual. The requirements sponsor. applicable to a sponsor-investigator (g) Index of legally marketed unap- under this part include both those approved new animal drugs for minor spe- plicable to an investigator and a spon- cies. All provisions of part 511 apply to sor. new animal drugs for investigational [77 FR 25359, Apr. 30, 2012] use in support of indexing, as described in section 572 of the act, subject to the provisions of § 516.125 of this chapter. PART 514—NEW ANIMAL DRUG APPLICATIONS [40 FR 13823, Mar. 27, 1975, as amended at 41 FR 48268, Nov. 2, 1976; 42 FR 15675, Mar. 22, 1977; 50 FR 7517, Feb. 22, 1985; 50 FR 16668, Subpart A—General Provisions Apr. 26, 1985; 52 FR 8847, Mar. 19, 1987; 54 FR Sec. 18280, Apr. 28, 1989; 57 FR 6475, Feb. 25, 1992; 514.1 Applications. 62 FR 40599, July 29, 1997; 72 FR 69121, Dec. 6, 514.3 Definitions. 2007; 77 FR 25359, Apr. 30, 2012] 514.4 Substantial evidence. 514.5 Presubmission conferences. § 511.3 Definitions. 514.6 Amended applications. As used in this part: 514.7 Withdrawal of applications without Contract research organization means a prejudice. person that assumes, as an independent 514.8 Supplements and other changes to an contractor with the sponsor, one or approved application. 514.11 Confidentiality of data and informa- more of the obligations of a sponsor, tion in a new animal drug application e.g., design of a protocol, selection or file. monitoring of investigations, evalua- 514.12 Confidentiality of data and information of reports, and preparation of mation in an investigational new animal terials to be submitted to the Food and drug notice. Drug Administration. 514.15 Untrue statements in applications. Investigator means an individual who actually conducts a clinical investiga- Subpart B—Administrative Actions on tion (i.e., under whose immediate di- Applications rection the drug is administered or dis- 514.80 Records and reports concerning expe- pensed to a subject). In the event an in- rience with approved new animal drugs. vestigation is conducted by a team of 514.100 Evaluation and comment on applica- individuals, the investigator is the re- tions. sponsible leader of the team. ‘‘Sub- 514.105 Approval of applications. investigator’’ includes any other indi- 514.106 Approval of supplemental applica- vidual member of that team. tions. 514.110 Reasons for refusing to file applica- Sponsor means a person who takes re- tions. sponsibility for and initiates a clinical 514.111 Refusal to approve an application. investigation. The sponsor may be an 514.115 Withdrawal of approval of applica- individual or pharmaceutical company, tions.

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514.116 Notice of withdrawal of approval of Any reference to information furnished application. by a person other than the applicant 514.117 Adequate and well-controlled stud- may not be considered unless its use is ies. authorized in a written statement 514.120 Revocation of order refusing to approve an application or suspending or signed by the person who submitted it. withdrawing approval of an application. (b) Applications for new animal drugs 514.121 Service of notices and orders. shall be submitted in triplicate and as- sembled in the manner prescribed by Subpart C—Hearing Procedures paragraph (b)(15) of this section, and 514.200 Contents of notice of opportunity for shall include the following informa- a hearing. tion, as appropriate to support the par- 514.201 Procedures for hearings. ticular submission: (1) Identification. Whether the submis- Subparts D–E [Reserved] sion is an original or supplemental application; the name and the address of Subpart F—Judicial Review the applicant; the date of the applica- 514.235 Judicial review. tion; the trade name(s) (if one has been proposed) and chemical name(s) of the AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 356a, new animal drug. Upon receipt, the ap- 360b, 371, 379e, 381. plication will be assigned a number SOURCE: 40 FR 13825, Mar. 27, 1975, unless NADA ll, which shall be used for all otherwise noted. correspondence with respect to the application. Subpart A—General Provisions (2) Table of contents and summary. The application shall be organized in a co- § 514.1 Applications. hesive fashion, shall contain a table of (a) Applications to be filed under sec- contents which identifies the data and tion 512(b) of the act shall be submitted other material submitted, and shall in the form and contain the informa- contain a well-organized summary and tion described in paragraph (b) of this evaluation of the data in the following section, as appropriate to support the form: particular submission. If any part of (i) Chemistry: the application is in a foreign lan- (a) Chemical structural formula or guage, an accurate and complete description for any new animal drug English translation shall be appended substance. to such part. Translations of literature (b) Relationship to other chemically printed in a foreign language shall be or pharmacologically related drugs. accompanied by copies of the original (c) Description of dosage form and publication. The application must be quantitative composition. signed by the applicant or by an au- (ii) Scientific rationale and purpose thorized attorney, agent, or official. If the new animal drug is to serve: the applicant or such authorized rep- (a) Clinical purpose. resentative does not reside or have a (b) Highlights of laboratory studies: place of business within the United The reasons why certain types of stud- States, the application must also fur- ies were done or omitted as related to nish the name and post office address the proposed conditions of use and to of, and must be countersigned by, an information already known about this authorized attorney, agent, or official class of compounds. Emphasize any un- residing or maintaining a place of busi- usual or particularly significant phar- ness within the United States. Perti- macological effects or toxicological nent information may be incorporated findings. in, and will be considered as part of, an (c) Highlights of clinical studies: The application on the basis of specific ref- rationale of the clinical study plan erence to such information, including showing why types of studies were information submitted under the provi- done, amended, or omitted as related sions of § 511.1 of this chapter, in the to laboratory studies and prior clinical files of the Food and Drug Administra- experience. tion; however, the reference must be (d) Conclusions: A short statement of specific in identifying the information. conclusions combining the major

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points of effectiveness and safety as cluding a full list of the composition of they relate to the use of the new ani- each article: mal drug. (i) A full list of the articles used as (3) Labeling. Three copies of each components of the new animal drug. piece of all labeling to be used for the This list should include all substances article (total of 9). used in the synthesis, extraction, or (i) All labeling should be identified to other method of preparation of any show its position on, or the manner in new animal drug and in the prepara- which it is to accompany the market tion of the finished dosage form, re- package. gardless of whether they undergo (ii) Labeling for nonprescription new chemical change or are removed in the animal drugs should include adequate process. Each component should be directions for use by the layman under identified by its established name, if all conditions of use for which the new any, or complete chemical name, using animal drug is intended, recommended, structural formulas when necessary for or suggested in any of the labeling or specific identification. If any propri- advertising sponsored by the applicant. etary name is used, it should be fol- (iii) Labeling for prescription veteri- lowed by a complete quantitative nary drugs should bear adequate infor- statement of composition. Reasonable mation for use under which veterinar- alternatives for any listed component ians can use the new animal drug safe- may be specified. ly and for the purposes for which it is (ii) A full statement of the composi- intended, including those purposes for tion of the new animal drug. The state- which it is to be advertised or rep- ment shall set forth the name and resented, in accord with § 201.105 of this amount of each ingredient, whether ac- chapter. tive or not, contained in a stated quan- (iv) All labeling for prescription or tity of the new animal drug in the form nonprescription new animal drugs shall in which it is to be distributed (for ex- be submitted with any necessary use ample, amount per tablet or milliliter) restrictions prominently and conspicu- and a batch formula representative of ously displayed. that to be employed for the manufac- (v) Labeling for new animal drugs in- ture of the finished dosage form. All tended for use in the manufacture of components should be included in the medicated feeds shall include: batch formula regardless of whether (a) Specimens of labeling to be used they appear in the finished product. for such new animal drug with ade- Any calculated excess of an ingredient quate directions for the manufacture over the label declaration should be and use of finished feeds for all condi- designated as such and percent excess tions for which the new animal drug is shown. Reasonable variation may be intended, recommended, or suggested specified. 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 other agents used. complete list of all articles used for (f) If the new animal drug is produced production of the new animal drug in- by a catalytic hydrogenation process

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(such as tetracycline from chlortetra- identity, strength, quality, and purity, cycline), a complete description of each the methods should be described in suf- chemical reaction with graphic for- ficient detail, including quantities mulas used to produce the new animal used, times, temperature, pH, solvents, drug, including the names of the cata- etc., to determine these characteris- lyst used, how it is removed, and how tics. Alternative methods or variations the new animal drug is extracted and in methods within reasonable limits purified. that do not affect such characteristics (5) Manufacturing methods, facilities, of the new animal drug may be speci- and controls. A full description of the fied. A flow sheet and indicated equa- methods used in, and the facilities and tions should be submitted when needed controls used for, the manufacture, to explain the process. processing, and packing of the new ani- (v) Precautions to insure proper iden- mal drug. This description should in- tity, strength, quality, and purity of clude full information with respect to the raw materials, whether active or any new animal drug in sufficient de- not, including: tail to permit evaluation of the ade- (a) The specifications for acceptance quacy of the described methods of man- and methods of testing for each lot of ufacture, processing, and packing, and raw material. the described facilities and controls to (b) A statement as to whether or not determine and preserve the identity, each lot of raw materials is given a se- strength, quality, and purity of the rial number to identify it, and the use new animal drug, and the following: made of such numbers in subsequent (i) If the applicant does not himself plant operations. perform all the manufacturing, proc- (vi) The instructions used in the essing, packaging, labeling, and control manufacturing, processing, packaging, operations for any new animal drug, he and labeling of each dosage form of the shall: Identify each person who will new animal drug, including: perform any part of such operations (a) The method of preparation of the and designate the part; and provide a master formula records and individual signed statement from each such per- batch records and the manner in which son fully describing, directly or by ref- these records are used. erence, the methods, facilities, and (b) The number of individuals check- controls he will use in his part of the ing weight or volume of each indi- operation. The statement shall include vidual ingredient entering into each a commitment that no changes will be batch of the new animal drug. made without prior approval by the (c) A statement as to whether or not Food and Drug Administration, unless the total weight or volume of each permitted under § 514.8. batch is determined at any stage of the (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.

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(vii) The analytical controls used way or planned. Stability data for the during the various stages of the manu- finished dosage form of the new animal facturing, processing, packaging, and drug in the container in which it is to labeling of the new animal drug, in- be marketed, including any proposed cluding a detailed description of the multiple dose container, and, if it is to collection of samples and the analyt- be put into solution at the time of dis- ical procedures to which they are sub- pensing, for the solution prepared as jected. The analytical procedures directed. If the new animal drug is in- should be capable of determining the tended for use in the manufacture of active components within a reasonable Type C medicated feed as defined in degree of accuracy and of assuring the § 558.3 of this chapter, stability data de- identity of such components. rived from studies in which representa- (a) A description of practicable meth- tive formulations of the medicated feed ods of analysis of adequate sensitivity articles are used. Similar data may be to determine the amount of the new required for Type B medicated feeds as animal drug in the final dosage form determined by the Food and Drug Ad- should be included. The dosage form ministration on a case-by-case basis. may be a finished pharmaceutical prod- Expiration dates shall be proposed for uct, a Type A medicated article, a Type finished pharmaceutical dosage forms B or a Type C medicated feed, or a and Type A medicated articles. If the product for use in animal drinking data indicate that an expiration date is water. Where two or more active ingre- needed for Type B or Type C medicated dients are included, methods should be feeds, the applicant shall propose such quantitative and specific for each ac- expiration date. If no expiration date is tive ingredient. proposed for Type B or Type C medi- (b) If the article is one that is rep- cated feeds, the applicant shall justify resented to be sterile, the same infor- its absence with data. mation with regard to the manufac- (xi) Additional procedures employed turing, processing, packaging, and the which are designed to prevent contami- collection of samples of the drug nation and otherwise assure proper should be given for sterility controls. control of the product. An application Include the standards used for accept- may be refused unless it includes ade- ance of each lot of the finished drug. quate information showing that the (viii) An explanation of the exact sig- methods used in, and the facilities and nificance of any batch control numbers controls used for, the manufacturing, used in the manufacturing, processing, processing, and packaging of the new packaging, and labeling of the new ani- animal drug are adequate to preserve mal drug, including such control num- its identity, strength, quality, and pu- bers that may appear on the label of rity in conformity with good manufac- 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

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subdivision of the sample, and to iden- methods employed in obtaining the re- tify each subdivision with the name of porting results. the applicant and the new animal drug (7) Analytical methods for residues. Ap- application to which it relates. In- plications shall include a description of cluded are: practicable methods for determining (a) A sample or samples of any ref- the quantity, if any, of the new animal erence standard and blank used in the drug in or on food, and any substance procedures described in the application formed in or on food because of its use, for assaying each new animal drug and and the proposed tolerance or with- other assayed components of the fin- drawal period or other use restrictions ished new animal drug. to ensure that the proposed use of this (b) A representative sample or sam- drug will be safe. When data or other ples of each strength of the finished adequate information establish that it dosage form proposed in the applica- is not reasonable to expect the new tion and employed in the clinical in- animal drug to become a component of vestigations and a representative sam- food at concentrations considered un- ple or samples of each new animal drug safe, a regulatory method is not re- from the batch(es) employed in the quired. production of such dosage form. (i) The kind of information required by this subdivision may include: Com- (c) A representative sample or sam- plete experimental protocols for deter- ples of finished market packages of mining drug residue levels in the edible each strength of the dosage form of the products, and the length of time renew animal drug prepared for initial quired for residues to be eliminated marketing and, if any such sample is from such products following the not from a representative commercial- drug’s use; residue studies conducted scale production batch, such a sample under appropriate (consistent with the from a representative commercial- proposed usage) conditions of dosage, scale production batch, and a rep- time, and route of administration to resentative sample or samples of each show levels, if any, of the drug and/or new animal drug from the batch(es) its metabolites in test animals during employed in the production of such and upon cessation of treatment and at dosage form, provided that in the case intervals thereafter in order to estab- of new animal drugs marketed in large lish a disappearance curve; if the drug packages the sample should contain is to be used in combination with other only three times a sufficient quantity drugs, possible effects of interaction of the new animal drug to allow for demonstrated by the appropriate dis- performing the control tests for drug appearance curve or depletion patterns identity and assays. after drug withdrawal under appro- (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,

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and eggs (yolk and egg white). As a a reprint of a published report that part of the metabolic studies, levels of only supports other data submitted. In- the drug or metabolite should be deter- clude any evaluation of the safety or mined in blood where feasible. Samples effectiveness of the new animal drug may be combined where necessary. that has been made by the applicant’s Where residues are suspected or known veterinary or medical department, ex- to be present in litter from treated ani- pert committee, or consultants. mals, it may be necessary to include (v) If the new animal drug is a com- data with respect to such residues be- bination of active ingredients or ani- coming components of other agricul- mal drugs, an application may be re- tural commodities because of use of lit- fused unless it includes substantial evi- ter from treated animals. dence of the effectiveness of the com- (ii) A new animal drug that has the bination new animal drug as required potential to contaminate human food in § 514.4. with residues whose consumption could (vi) An application shall include a present a risk of cancer to people must complete list of the names and post of- satisfy the requirements of subpart E fice addresses of all investigators who of part 500 of this chapter. received the new animal drug. This (8) Evidence to establish safety and ef- may be incorporated in whole or in fectiveness. (i) An application may be part by reference to information sub- refused unless it contains full reports mitted under the provisions of § 511.1 of of adequate tests by all methods rea- this chapter. sonably applicable to show whether or (vii) Explain any omission of reports not the new animal drug is safe and ef- from any investigator to whom the infective for use as suggested in the pro- vestigational new animal drug has been posed labeling. made available. The unexplained omis- (ii) An application may be refused sion of any reports of investigations unless it includes substantial evidence made with the new animal drug by the of the effectiveness of the new animal applicant or submitted to him by an in- drug as defined in § 514.4. (iii) An application may be refused vestigator or the unexplained omission unless it contains detailed reports of of any pertinent reports of investiga- the investigations, including studies tions or clinical experience received or made on laboratory animals, in which otherwise obtained by the applicant the purpose, methods, and results ob- from published literature or other tained are clearly set forth of acute, sources that would bias an evaluation subacute, and chronic toxicity, and un- of the safety of the new animal drug or less it contains appropriate clinical its effectiveness in use, constitutes laboratory results related to safety and grounds for the refusal or withdrawal efficacy. Such information should in- of the approval of an application. clude identification of the person who (viii) If a sponsor has transferred any conducted each investigation, a state- obligations for the conduct of any clin- ment of where the investigations were ical study to a contract research orga- conducted, and where the raw data are nization, the application is required to available in the application. include a statement containing the (iv) All information pertinent to an name and address of the contract reevaluation of the safety and effective- search organization, identifying the ness of the new animal drug received or clinical study, and listing the obliga- otherwise obtained by the applicant tions transferred. If all obligations gov- from any source, including information erning the conduct of the study have derived from other investigations or been transferred, a general statement commercial marketing (for example, of this transfer—in lieu of a listing of outside the United States), or reports the specific obligations transferred— in the scientific literature, both favor- may be submitted. able and unfavorable, involving the (ix) If original subject records were new animal drug that is the subject of audited or reviewed by the sponsor in the application and related new animal the course of monitoring any clinical drugs shall be submitted. An adequate study to verify the accuracy of the case summary may be acceptable in lieu of reports submitted to the sponsor, a list

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identifying each clinical study so au- brief statement of the reason for the dited or reviewed. noncompliance. (9) Veterinary feed directive. Three (13) [Reserved] copies of a veterinary feed directive (14) Environmental assessment. The ap- (VFD) must be submitted in the format plicant is required to submit either a described under § 558.6(a)(4) of this claim for categorical exclusion under chapter. § 25.30 or § 25.33 of this chapter or an en- (10) Supplemental applications. If it is vironmental assessment under § 25.40 of a supplemental application, full infor- this chapter. mation shall be submitted on each pro- (15) Assembling and binding the appli- posed change concerning any state- cation. Assemble and bind an original ment made in the approved applica- and two copies of the application as tion. follows: (11) Applicant’s commitment. It is un- (i) Bind the original or ribbon copy of derstood that the labeling and adver- the application as copy No. 1. tising for the new animal drug will pre- (ii) Bind two identical copies as copy scribe, recommend, or suggest its use No. 2 and copy No. 3. only under the conditions stated in the (iii) Identify each front cover with labeling which is part of this applica- the name of the applicant, new animal tion and if the article is a prescription drug, and the copy number. (iv) Number each page of the applica- new animal drug, it is understood that tion sequentially in the upper right any labeling which furnishes or pur- hand corner or in another location so ports to furnish information for use or that the page numbers remain legible which prescribes, recommends, or sug- after the application has been bound, gests a dosage for use of the new ani- and organize the application consistent mal drug will also contain, in the same with paragraphs (b) (1) through (14) of language and emphasis, information this section. Each copy should bear the for its use including indications, ef- same page numbering, whether sequen- fects, dosages, routes, methods, and tial in each volume or continuous and frequency and duration of administra- sequential throughout the application. tion, any relevant hazards, contra- (v) Include complete labeling in each indications, side effects, and pre- of the copies. It is suggested that label- cautions contained in the labeling ing be identified by date of printing or which is part of this application. It is date of preparation. understood that all representations in (vi) Submit separate applications for this application apply to the drug pro- each different dosage form of the drug duced until changes are made in con- proposed. Repeating basic information formity with § 514.8. pertinent to all dosage forms in each (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

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that the drug has a potential for abuse, NADA is a new animal drug applica- the Commissioner shall forward that tion including all amendments and sup- information to the Attorney General of plements. the United States. Nonapplicant is any person other than the applicant whose name appears on [40 FR 13825, Mar. 27, 1975] the label and who is engaged in manu- EDITORIAL NOTE: For FEDERAL REGISTER ci- facturing, packing, distribution, or la- tations affecting § 514.1, see the List of CFR beling of the product. Sections Affected, which appears in the Potential applicant means any person: Finding Aids section of the printed volume (1) Intending to investigate a new and at www.fdsys.gov. animal drug under section 512(j) of the Federal Food, Drug, and Cosmetic Act § 514.3 Definitions. (the act), The definition and interpretation of (2) Investigating a new animal drug terms contained in this section apply under section 512(j) of the act, to those terms as used throughout sub- (3) Intending to file a new animal chapter E. drug application (NADA) or supple- Adverse drug experience is any adverse mental NADA under section 512(b)(1) of event associated with the use of a new the act, or animal drug, whether or not considered (4) Intending to file an abbreviated to be drug related, and whether or not new animal drug application (ANADA) the new animal drug was used in ac- under section 512(b)(2) of the act. cordance with the approved labeling Presubmission conference means one or (i.e., used according to label directions more conferences between a potential or used in an extralabel manner, in- applicant and FDA to reach a binding cluding but not limited to different agreement establishing a submission or route of administration, different spe- investigational requirement. cies, different indications, or other Presubmission conference agreement than labeled dosage). Adverse drug ex- means that section of the memo- perience includes, but is not limited to: randum of conference headed ‘‘Pre- (1) An adverse event occurring in ani- submission Conference Agreement’’ mals in the course of the use of an ani- that records any agreement on the sub- mal drug product by a veterinarian or mission or investigational requirement by a livestock producer or other ani- reached by a potential applicant and mal owner or caretaker. FDA during the presubmission con- (2) Failure of a new animal drug to ference. Product defect/manufacturing defect is produce its expected pharmacological the deviation of a distributed product or clinical effect (lack of expected ef- from the standards specified in the ap- fectiveness). proved application, or any significant (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.

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Serious adverse drug experience is an conditions of use for and under which adverse event that is fatal, or life- approval is sought. threatening, or requires professional (i) Dose range labeling. Sponsors intervention, or causes an abortion, or should, to the extent possible, provide stillbirth, or infertility, or congenital for a dose range because it increases anomaly, or prolonged or permanent the utility of the new animal drug by disability, or disfigurement. providing the user flexibility in the se- Unexpected adverse drug experience is lection of a safe and effective dose. In an adverse event that is not listed in general, substantial evidence to sup- the current labeling for the new animal port dose range labeling for a new ani- drug and includes any event that may mal drug intended for use in the diag- be symptomatically and nosis, cure, mitigation, treatment, or pathophysiologically related to an prevention of disease must consist of at event listed on the labeling, but differs least one adequate and well-controlled from the event because of greater se- study on the basis of which qualified verity or specificity. For example, experts could fairly and reasonably under this definition hepatic necrosis conclude that the new animal drug will would be unexpected if the labeling re- be effective for the intended use at the ferred only to elevated hepatic en- lowest dose of the dose range suggested zymes or hepatitis. in the proposed labeling for that in- [68 FR 15365, Mar. 31, 2003, as amended at 69 tended use. Substantial evidence to FR 51170, Aug. 18, 2004] support dose range labeling for a new animal drug intended to affect the § 514.4 Substantial evidence. structure or function of the body of an (a) Definition of substantial evidence. animal generally must consist of at Substantial evidence means evidence least one adequate and well-controlled consisting of one or more adequate and study on the basis of which qualified well-controlled studies, such as a study experts could fairly and reasonably in a target species, study in laboratory conclude that the new animal drug will animals, field study, bioequivalence be effective for the intended use at all study, or an in vitro study, on the basis doses within the range suggested in the of which it could fairly and reasonably proposed labeling for the intended use. be concluded by experts qualified by (ii) [Reserved] scientific training and experience to (3) Studies—(i) Number. Substantial evaluate the effectiveness of the new evidence of the effectiveness of a new animal drug involved that the new ani- animal drug for each intended use and mal drug will have the effect it pur- associated conditions of use shall con- ports or is represented to have under sist of a sufficient number of current the conditions of use prescribed, rec- adequate and well-controlled studies of ommended, or suggested in the labeling sufficient quality and persuasiveness to or proposed labeling thereof. Substan- permit qualified experts: tial evidence shall include such ade- (A) To determine that the param- quate and well-controlled studies that eters selected for measurement and the are, as a matter of sound scientific measured responses reliably reflect the judgment, necessary to establish that a effectiveness of the new animal drug; new animal drug will have its intended (B) To determine that the results ob- effect. tained are likely to be repeatable, and (b) Characteristics of substantial evi- that valid inferences can be drawn to dence(1) Qualifications of experts. Any the target animal population; and study that is intended to be part of (C) To conclude that the new animal substantial evidence of the effective- drug is effective for the intended use at ness of a new animal drug shall be con- the dose or dose range and associated ducted by experts qualified by sci- conditions of use prescribed, rec- entific training and experience. ommended, or suggested in the pro- (2) Intended uses and conditions of use. posed labeling. Substantial evidence of effectiveness of (ii) Types. Adequate and well-con- a new animal drug shall demonstrate trolled studies that are intended to that the new animal drug is effective provide substantial evidence of the ef- for each intended use and associated fectiveness of a new animal drug may

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include, but are not limited to, pub- ingredient or animal drug in the com- lished studies, foreign studies, studies bination makes a contribution to the using models, and studies conducted by effectiveness of the combination new or on behalf of the sponsor. Studies animal drug; using models shall be validated to es- (B) That each active ingredient or tablish an adequate relationship of pa- animal drug intended for at least one rameters measured and effects ob- use that is different from all the other served in the model with one or more active ingredients or animal drugs used significant effects of treatment. in the combination provides appro- (c) Substantial evidence for combination priate concurrent use for the intended new animal drugs(1) Definitions. The fol- target animal population; and lowing definitions of terms apply to (C) That the active ingredients or this section: animal drugs are physically compatible (i) Combination new animal drug and do not have disparate dosing regi- means a new animal drug that contains mens if FDA, based on scientific infor- more than one active ingredient or ani- mation, has reason to believe the ac- mal drug that is applied or adminis- tive ingredients or animal drugs are tered simultaneously in a single dosage physically incompatible or have dis- form or simultaneously in or on animal parate dosing regimens. feed or drinking water. (ii) For combination new animal (ii) Dosage form combination new ani- drugs intended for use in animal feed mal drug means a combination new ani- or drinking water that contain only ac- mal drug intended for use other than in tive ingredients or animal drugs that animal feed or drinking water. have previously been separately ap- (iii) Antibacterial with respect to a proved for the particular uses and con- particular target animal species means ditions of use for which they are in- an active ingredient or animal drug: tended in combination, the sponsor That is approved in that species for the shall demonstrate: diagnosis, cure, mitigation, treatment, or prevention of bacterial disease; or (A) By substantial evidence, as de- that is approved for use in that species fined in this section, that any active for any other use that is attributable ingredient or animal drug intended to its antibacterial properties. But, only for the same use as another active antibacterial does not include ingredient or animal drug in the com- ionophores or arsenicals intended for bination makes a contribution to the use in combination in animal feed or effectiveness of the combination new drinking water. animal drug; (iv) Appropriate concurrent use exists (B) For such combination new animal when there is credible evidence that drugs that contain more than one anti- the conditions for which the combina- bacterial ingredient or animal drug, by tion new animal drug is intended can substantial evidence, as defined in this occur simultaneously. section, that each antibacterial makes (2) Combination new animal drugs that a contribution to labeled effectiveness; contain only active ingredients or animal (C) That each active ingredient or drugs that have previously been sepa- animal drug intended for at least one rately approved. (i) For dosage form use that is different from all other ac- combination new animal drugs, except tive ingredients or animal drugs used for those that contain a nontopical in the combination provides appro- antibacterial, that contain only active priate concurrent use for the intended ingredients or animal drugs that have target animal population; and previously been separately approved (D) That the active ingredients or for the particular uses and conditions animal drugs intended for use in drink- of use for which they are intended in ing water are physically compatible if combination, a sponsor shall dem- FDA, based on scientific information, onstrate: has reason to believe the active ingre- (A) By substantial evidence, as de- dients or animal drugs are physically fined in this section, that any active incompatible. ingredient or animal drug intended (3) Other combination new animal only for the same use as another active drugs. For all other combination new

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animal drugs, the sponsor shall dem- referenced relative to issues listed in onstrate by substantial evidence, as de- the agenda for the conference. If the fined in this section, that the combina- materials are not provided or are not tion new animal drug will have the ef- sufficient to provide the basis for fect it purports or is represented to meaningful discussion, FDA may elect have under the conditions of use pre- to postpone part or all of the meeting scribed, recommended, or suggested in until sufficient materials are provided the proposed labeling and that each ac- to FDA. tive ingredient or animal drug contrib- (e) Conduct of a presubmission con- utes to the effectiveness of the com- ference. The potential applicant and bination new animal drug. FDA may each bring consultants to the [64 FR 40756, July 28, 1999] presubmission conference. The presubmission conference(s) will be di- § 514.5 Presubmission conferences. rected primarily at establishing agree- (a) General principle underlying the ment between FDA and the potential conduct of a presubmission conference. applicant regarding a submission or in- The general principle underlying the vestigational requirement. The submis- conduct of any presubmission con- sion or investigational requirement ference is that there should be candid, may include, among other things, the full, and open communication. number, types, and general design of (b) Requesting a presubmission con- studies that are necessary to dem- ference. A potential applicant is enti- onstrate the safety and effectiveness of tled to one or more conferences prior a new animal drug for the intended to the submission of an NADA, supple- uses and conditions of use prescribed, mental NADA, or an ANADA to reach recommended, or suggested in the pro- an agreement establishing part or all posed labeling for the new animal drug. of a submission or investigational re- (f) Documentation of a presubmission quirement. A potential applicant’s re- conference(1) Memorandum of con- quest for a presubmission conference ference—(i) Preparation. FDA will pre- must be submitted to FDA in a signed pare a memorandum for each pre- letter. The letter must include a pro- submission conference that will in- posed agenda that clearly outlines the clude, among other things, any back- scope, purpose, and objectives of the ground pertinent to the request for presubmission conference and must list meeting; a summary of the key points the names and positions of the rep- of discussion; agreements; and action resentatives who are expected to at- items and assignments of responsi- tend the presubmission conference on bility. That portion of the memo- behalf of the applicant. randum of conference that documents (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

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changes to, or clarification of, the sub- (2) FDA by written order determines stance of the memorandum, the re- that a substantiated scientific require- quest must be sent to FDA within 30 ment essential to the determination of calendar days from the date a copy of safety or effectiveness of the new ani- the memorandum is sent to the appli- mal drug appeared after the con- cant. If the potential applicant reference. quests changes or clarification, FDA (h) When the terms of a presubmission will send the potential applicant a re- conference agreement are not valid(1) A sponse to their request no later than 45 presubmission conference agreement calendar days after the date of receipt will no longer be valid if: of the request. (i) The potential applicant makes to (iv) Administrative record. A copy of FDA, before, during, or after the pre- FDA’s original memorandum of con- submission conference, any untrue ference and, as appropriate, a copy of statement of material fact; or an amended memorandum to correct or (ii) The potential applicant fails to clarify the content of the original follow any material term of the agree- memorandum will be made part of the ment; and administrative file. (2) A presubmission conference may (2) Field studies. If FDA requires more no longer be valid if the potential ap- than one field study to establish by plicant submits false or misleading substantial evidence that the new ani- data relating to a new animal drug to mal drug is effective for its intended FDA. uses under the conditions of use pre- (i) Dispute resolution. FDA is com- scribed, recommended, or suggested in mitted to resolving differences between the proposed labeling, FDA will provide a potential applicant and FDA review- written scientific justification for re- ing divisions with respect to require- quiring more than one field study. ments for the investigation of new ani- Such justification must be provided no mal drugs and for NADAs, supple- later than 25 calendar days after the mental NADAs, and ANADAs as quick- date of the conference at which the rely and amicably as possible through a quirement for more than one field cooperative exchange of information study is established. If FDA does not and views. When administrative or pro- believe more than one field study is re- cedural disputes arise, a potential ap- quired but the potential applicant vol- plicant should first attempt to resolve untarily proposes to conduct more the matter within the appropriate re- than one field study, FDA will not pro- view division beginning with the indi- vide such written justification. If FDA vidual(s) most directly assigned to the requires one field study to be con- review of the application or investiga- ducted at multiple locations, FDA will tional exemption. If the dispute cannot provide justification for requiring mul- be resolved after such attempts, the tiple locations verbally during the pre- dispute shall be evaluated and adminis- submission conference and in writing tered in accordance with applicable as part of the memorandum of con- regulations (21 CFR 10.75). Dispute res- ference. olution procedures may be further ex- (g) Modification of presubmission con- plained by guidance available from the ference agreements. An agreement made Center for Veterinary Medicine. under a presubmission conference requested under section 512(b)(3) of the [69 FR 51170, Aug. 18, 2004] act and documented in a memorandum of conference is binding on the poten- § 514.6 Amended applications. tial applicant and FDA and may only The applicant may submit an amend- be modified if: ment to an application that is pending, (1) FDA and the potential applicant including changes that may alter the mutually agree to modify, in part or in conditions of use, the labeling, safety, whole, the agreement and such modi- effectiveness, identity, strength, qual- fication is documented and provided to ity, or purity of the drug or the ade- the potential applicant as described in quacy of the manufacturing methods, paragraph (f)(1) of this section; or facilities, and controls to preserve

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them, in which case the unamended ap- (iv) Specification means the quality plication may be considered as with- standard (i.e., tests, analytical proce- drawn and the amended application dures, and acceptance criteria) pro- may be considered resubmitted on the vided in an approved application to date on which the amendment is re- confirm the quality of drugs including, ceived by the Food and Drug Adminis- for example, drug substances, Type A tration. The applicant will be notified medicated articles, drug products, of such date. intermediates, raw materials, reagents, components, in-process materials, con- § 514.7 Withdrawal of applications tainer closure systems, and other ma- without prejudice. terials used in the production of a The sponsor may withdraw his pend- drug. For the purpose of this defini- ing application from consideration as a tion, the term ‘‘acceptance criteria’’ new animal drug application upon writ- means numerical limits, ranges, or ten notification to the Food and Drug other criteria for the tests described. Administration. Such withdrawal may (b) Manufacturing changes to an ap- be made without prejudice to a future proved application (1) General provisions. filing. Upon resubmission, the time (i) The applicant must notify FDA limitation will begin to run from the about each change in each condition date the resubmission is received by established in an approved application the Food and Drug Administration. beyond the variations already provided The original application will be re- for in the application. The notice is retained by the Food and Drug Adminis- quired to describe the change fully. De- tration although it is considered with- pending on the type of change, the ap- drawn. The applicant shall be furnished plicant must notify FDA about it in a a copy at cost on request. supplement under paragraph (b)(2) or (b)(3) of this section or by inclusion of § 514.8 Supplements and other changes the information in the annual report to to an approved application. the application under paragraph (b)(4) (a) Definitions. (1) The definitions and of this section. interpretations contained in section 201 (ii) The holder of an approved appli- of the Federal Food, Drug, and Cos- cation under section 512 of the act metic Act (the act) apply to those must assess the effects of the change terms when used in this part. before distributing a drug made with a (2) The following definitions of terms manufacturing change. apply to this part: (iii) Notwithstanding the require- (i) Assess the effects of the change ments of paragraphs (b)(2) and (b)(3) of means to evaluate the effects of a man- this section, an applicant must make a ufacturing change on the identity, change provided for in those para- strength, quality, purity, and potency graphs in accordance with a regulation 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.

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(v) A supplement or annual report de- (2) Changes in the source material or scribed in paragraph (b)(4) of this sec- cell line, and tion must include a list of all changes (3) Establishment of a new master contained in the supplement or annual cell bank or seed; report. For supplements, this list must (G) Changes to a drug under an appli- be provided in the cover letter. cation that is subject to a validity as- (2) Changes requiring submission and sessment because of significant ques- approval of a supplement prior to dis- tions regarding the integrity of the tribution of the drug made using the data supporting that application. change (major changes). (i) A supple- (iii) The applicant must obtain ap- ment must be submitted for any proval of a supplement from FDA prior change in the drug, production process, to distribution of a drug made using a quality controls, equipment, or facili- change under paragraph (b)(2) of this ties that has a substantial potential to section. The supplement must be la- have an adverse effect on the identity, beled ‘‘Prior Approval Supplement.’’ strength, quality, purity, or potency of Except for submissions under para- the drug as these factors may relate to graph (b)(2)(v) of this section, the fol- the safety or effectiveness of the drug. lowing information must be contained (ii) These changes include, but are in the supplement: not limited to: (A) A completed Form FDA 356V; (A) Except those described in para- (B) A detailed description of the pro- graphs (b)(3) and (b)(4) of this section, posed change; changes in the qualitative or quan- (C) The drug(s) involved; titative formulation of the drug, in- (D) The manufacturing site(s) or cluding inactive ingredients, or in the area(s) affected; specifications provided in the approved (E) A description of the methods used application; and studies performed to assess the ef- (B) Changes requiring completion of fects of the change; appropriate clinical studies to dem- (F) The data derived from such stud- onstrate the equivalence of the drug to ies; the drug as manufactured without the (G) Appropriate documentation (for change; example, updated master batch (C) Changes that may affect drug records, specification sheets) including substance or drug product sterility as- previously approved documentation surance, such as changes in drug sub- (with the changes highlighted) or ref- stance, drug product or component erences to previously approved docu- sterilization method(s) or an addition, mentation; deletion, or substitution of steps in an (H) For a natural product, a recom- aseptic processing operation; binant DNA-derived protein/ (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

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making the change described in it (2) Replacement of equipment with would impose an extraordinary hard- that of a different design that does not ship on the applicant. Such a supple- affect the process methodology or proc- ment and its mailing cover must be ess operating parameters. plainly marked: ‘‘Prior Approval Sup- (C) Relaxation of an acceptance cri- plement-Expedited Review Requested.’’ terion or deletion of a test to comply (v) Comparability Protocols. An appli- with an official compendium that is cant may submit one or more protocols consistent with FDA statutory and reg- describing the specific tests and studies ulatory requirements. and acceptance criteria to be achieved (iii) A supplement submitted under to demonstrate the lack of adverse ef- paragraph (b)(3)(i) or (b)(3)(vi) of this fect for specified types of manufac- section is required to give a full expla- turing changes on the identity, nation of the basis for the change and strength, quality, purity, and potency identify the date on which the change of the drug as these factors may relate is made. The supplement submitted to the safety or effectiveness of the under paragraph (b)(3)(i) must be la- drug. Any such protocols, if not in- beled ‘‘Supplement-Changes Being Ef- cluded in the approved application, or fected in 30 Days.’’ changes to an approved protocol, must (iv) Pending approval of the supple- be submitted as a supplement requiring ment by FDA and except as provided in approval from FDA prior to distribu- paragraph (b)(3)(vi) of this section, dis- tion of the drug produced with the tribution of the drug made using the manufacturing change. The supple- change may begin not less than 30 days ment, if approved, may subsequently after receipt of the supplement by justify a reduced reporting category for FDA. The information listed in para- the particular change because the use graphs (b)(2)(iii)(A) through of the protocol for that type of change (b)(2)(iii)(J) of this section must be reduces the potential risk of an adverse contained in the supplement. effect. A comparability protocol supplement must be labeled ‘‘Prior Ap- (v) The applicant must not distribute proval Supplement—Comparability the drug made using the change if Protocol.’’ within 30 days following FDA’s receipt (3) Changes requiring submission of a of the supplement, FDA informs the supplement at least 30 days prior to dis- applicant that either: tribution of the drug made using the (A) The change requires approval change (moderate changes). (i) A supple- prior to distribution of the drug in ac- ment must be submitted for any cordance with paragraph (b)(2) of this change in the drug, production process, section; or 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 sup- (1) An increase or decrease in produc- plement must be labeled ‘‘Supplement- tion scale during finishing steps that Changes Being Effected.’’ These involves different equipment, and changes include, but are not limited to:

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(A) Addition to a specification or equivalency to the approved system changes in the methods or controls to under a protocol approved in the appli- provide increased assurance that the cation or published in an official com- drug will have the characteristics of pendium; identity, strength, quality, purity, or (F) An extension of an expiration potency that it purports or is rep- dating period based upon full shelf-life resented to possess; and data on production batches obtained (B) A change in the size and/or shape from a protocol approved in the appli- of a container for a nonsterile drug cation; product, except for solid dosage forms, (G) The addition or revision of an al- without a change in the labeled ternative analytical procedure that amount of drug product or from one provides the same or increased assur- container closure system to another. ance of the identity, strength, quality, (vii) If the agency disapproves the purity, or potency of the drug being supplemental application, it may order tested as the analytical procedure de- the manufacturer to cease distribution scribed in the approved application, or of the drug(s) made with the manufac- deletion of an alternative analytical turing change. procedure; and (4) Changes and updated stability data (H) The addition by embossing, de- to be described and submitted in an an- bossing, or engraving of a code imprint nual report (minor changes). (i) Changes to a solid oral dosage form drug prod- in the drug, production process, quality uct other than a modified release dos- controls, equipment, or facilities that age form, or a minor change in an ex- have a minimal potential to have an isting code imprint. adverse effect on the identity, (iii) For changes under this category, strength, quality, purity, or potency of the applicant is required to submit in the drug as these factors may relate to the annual report: the safety or effectiveness of the drug (A) A completed Form FDA 356V; must be documented by the applicant (B) A statement by the holder of the in an annual report to the application approved application that the effects of as described under paragraph (a)(2)(iii) the change have been assessed; of this section. The report must be la- (C) A detailed description of the beled ‘‘Minor Changes and Stability change(s); Report.’’ (ii) These changes include but are not (D) The manufacturing site(s) or limited to: area(s) involved; (A) Any change made to comply with (E) The date each change was imple- a change to an official compendium, mented; 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

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according to an approved stability pro- (D) The data derived from studies in tocol or commitment; and support of the change; and (J) Any other information as directed (E) Any other information as di- by FDA. rected by FDA. (c) Labeling and other changes to an (3) Labeling changes to be placed into approved application(1) General provi- effect prior to receipt of a written notice sions. The applicant must notify FDA of approval of a supplemental application. about each change in each condition (i) Labeling changes of the following established in an approved application kinds that increase the assurance of beyond the variations already provided drug safety proposed in supplemental for in the application. The notice is re- applications must be placed into effect quired to describe the change fully. immediately: (2) Labeling changes requiring the sub- (A) The addition to package labeling, mission and approval of a supplement promotional labeling, or prescription prior to distribution of the drug made drug advertising of additional warning, using the change (major changes). (i) Ad- contraindication, adverse reaction, and dition of intended uses and changes to precaution information; package labeling require a supplement. (B) The deletion from package label- These changes include, but are not lim- ing, promotional labeling, or drug ad- ited to: vertising of false, misleading, or unsup- (A) Revision in labeling, such as up- ported intended uses or claims for ef- dating information pertaining to effectiveness; and fects, dosages, adverse reactions, con- (C) Any other changes as directed by traindications, which includes informa- FDA. tion headed ‘‘adverse reactions,’’ (ii) Labeling changes (for example, ‘‘warnings,’’ ‘‘precautions,’’ and ‘‘con- design and style) that do not decrease traindications,’’ except ones described safety of drug use proposed in supple- in (c)(3) of this section; mental applications may be placed into (B) Addition of an intended use; effect prior to written notice of approval from FDA of a supplemental ap- (C) If it is a prescription drug, any plication. mailing or promotional piece used (iii) A supplement submitted under after the drug is placed on the market paragraph (c)(3) of this section must in- is labeling requiring a supplemental clude the following information: application, unless: (A) A full explanation of the basis for (1) The parts of the labeling fur- the changes, the date on which such nishing directions, warnings, and infor- changes are being effected, and plainly mation for use of the drug are the same marked on the mailing cover and on 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

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act. In addition, under section 512(e) of (b) The existence of an NADA file the act, FDA may, after due notice and will not be disclosed by the Food and opportunity for a hearing, issue an Drug Administration before an ap- order withdrawing approval of the approval has been published in the FED- plication. ERAL REGISTER, unless it has pre- (4) Changes providing for additional viously been publicly disclosed or ac- distributors to be reported under Records knowledged. and reports concerning experience with (c) If the existence of an NADA file approved new animal drugs (§ 514.80). has not been publicly disclosed or ac- Supplemental applications as described knowledged, no data or information in under paragraph (c)(2) of this section the NADA file is available for public will not be required for an additional disclosure. distributor to distribute a drug that is (d) If the existence of an NADA file the subject of an approved new animal has been publicly disclosed or acknowl- drug application or abbreviated new edged before an approval has been pub- animal drug application if the condi- lished in the FEDERAL REGISTER, no tions described under § 514.80(b)(5)(iii) data or information contained in the are met. file is available for public disclosure (d) Patent information. The applicant before such approval is published, but must comply with the patent informa- the Commissioner may, in his discretion requirements under section tion, disclose a summary of such se- 512(c)(3) of the act. lected portions of the safety and effec- (e) Claimed exclusivity. If an applicant tiveness data as are appropriate for claims exclusivity under section 512(c)(2)(F) of the act upon approval of public consideration of a specific pend- a supplemental application for a ing issue, e.g., at an open session of a change in its previously approved drug, Food and Drug Administration advi- the applicant must include such a sory committee or pursuant to an ex- statement. change of important regulatory infor- (f) Good laboratory practice for nonclin- mation with a foreign government. ical laboratory studies. A supplemental (e) After an approval has been pub- application that contains nonclinical lished in the FEDERAL REGISTER, the laboratory studies must include, with following data and information in the respect to each nonclinical study, ei- NADA file are immediately available ther a statement that the study was for public disclosure unless extraor- conducted in compliance with the re- dinary circumstances are shown: quirements set forth in part 58 of this (1) All safety and effectiveness data chapter, or, if the study was not con- and information previously disclosed to ducted in compliance with such regula- the public, as defined in § 20.81 of this tions, a brief statement of the reason chapter. for the noncompliance. (2) A summary or summaries of the safety and effectiveness data and infor- [71 FR 74782, Dec. 13, 2006] mation submitted with or incorporated § 514.11 Confidentiality of data and in- by reference in the NADA file. Such formation in a new animal drug ap- summaries do not constitute the full plication file. reports of investigations under section (a) For purposes of this section the 512(b)(1) of the act (21 U.S.C. 360b(b)(1)) NADA file includes all data and infor- on which the safety or effectiveness of mation submitted with or incorporated the drug may be approved. Such sum- by reference in the NADA, INAD’s in- maries shall consist of the following: corporated into the NADA, supple- (i) For an NADA approved prior to mental NADA’s, reports under §§ 514.80 July 1, 1975, internal agency records and 510.301 of this chapter, master files, that describe such data and informa- and other related submissions. The tion, e.g., a summary of basis for ap- availability for public disclosure of any proval or internal reviews of the data record in the NADA file shall be han- and information, after deletion of: dled in accordance with the provisions (a) Names and any information that of this section. would identify the investigators.

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(b) Any inappropriate gratuitous (2) A final determination is made comments unnecessary to an objective that the NADA is not approvable, and analysis of the data and information. all legal appeals have been exhausted. (ii) For an NADA approved on or (3) Approval of the NADA is with- after July 1, 1975, a summary of such drawn, and all legal appeals have been data and information prepared in one exhausted. of the following two alternative ways (4) A final determination has been shall be publicly released when the ap- made that the animal drug is not a new proval is published in the FEDERAL animal drug. REGISTER. (5) A final determination has been (a) The Center for Veterinary Medi- made that the animal drug may be cine may at an appropriate time prior marketed without submission of such to approval of the NADA require the safety and/or effectiveness data and in- applicant to prepare a summary of formation. such data and information, which will be reviewed and, where appropriate, re- (g) The following data and informa- vised by the Center. tion in an NADA file are not available (b) The Center for Veterinary Medi- for public disclosure unless they have cine may prepare its own summary of been previously disclosed to the public such data and information. as defined in § 20.81 of this chapter or (3) A protocol for a test or study, un- they relate to a product or ingredient less it is shown to fall within the ex- that has been abandoned and they no emption established for trade secrets longer represent a trade secret or con- and confidential commercial informa- fidential commercial or financial infor- tion in § 20.61 of this chapter. mation as defined in § 20.61 of this chap- (4) Adverse reaction reports, product ter: experience reports, consumer com- (1) Manufacturing methods or proc- plaints, and other similar data and in- esses, including quality control proce- formation, after deletion of: dures. (i) Names and any information that (2) Production, sales, distribution, would identify the person using the and similar data and information, ex- product. cept that any compilation of such data (ii) Names and any information that and information aggregated and pre- would identify any third party involved pared in a way that does not reveal with the report, such as a physician, data or information which is not avail- hospital, or other institution. able for public disclosure under this (5) A list of all active ingredients and provision is available for public disclo- any inactive ingredients previously sure. disclosed to the public as defined in (3) Quantitative or semiquantitative § 20.81 of this chapter. formulas. (6) An assay method or other analyt- (h) For purposes of this regulation, ical method, unless it serves no regu- safety and effectiveness data include latory or compliance purpose and is all studies and tests of an animal drug shown to fall within the exemption es- on animals and all studies and tests on tablished in § 20.61 of this chapter. the animal drug for identity, stability, (7) All correspondence and written purity, potency, and bioavailability. summaries of oral discussions relating to the NADA, in accordance with the [40 FR 13825, Mar. 27, 1975, as amended at 42 provisions of part 20 of this chapter. FR 3109, Jan. 14, 1977; 42 FR 15675, Mar. 22, (f) All safety and effectiveness data 1977; 54 FR 18280, Apr. 28, 1989; 68 FR 15365, and information not previously dis- Mar. 31, 2003] closed to the public are available for EFFECTIVE DATE NOTE: At 79 FR 14611, Mar. public disclosure at the time any one of 17, 2014, § 514.11 was amended by revising the following events occurs unless ex- paragraphs (b), (d), (e) introductory text, and traordinary circumstances are known: (e)(2)(ii) introductory text, effective July 30, (1) The NADA has been abandoned 2014. For the convenience of the user, the re- and no further work is being under- vised text is set forth as follows: taken with respect to it.

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§ 514.11 Confidentiality of data and informa- feed bearing or containing a new ani- tion in a new animal drug application mal drug may contain an untrue state- file. ment of a material fact are: (a) Differences in: * * * * * (1) Conditions of use prescribed, rec- (b) The existence of an NADA file will not ommended, or suggested by the appli- be disclosed by the Food and Drug Adminis- cant for the product from the condi- tration before the application has been ap- tions of such use stated in the applica- proved, unless it has been previously dis- tion; closed or acknowledged. (2) Articles used as components of the product from those listed in the ap- * * * * * plication; (d) If the existence of an NADA file has (3) Composition of the product from been publicly disclosed or acknowledged be- that stated in the application; fore the application has been approved, no (4) Methods used in or the facilities data or information contained in the file is available for public disclosure, but the Com- and controls used for the manufacture, missioner may, in his discretion, disclose a processing, or packing of the product summary of such selected portions of the from such methods, facilities, and con- safety and effectiveness data as are appro- trols described in the application; priate for public consideration of a specific (5) Labeling from the specimens con- pending issue, i.e., at an open session of a tained in the application; or Food and Drug Administration advisory (b) The unexplained omission in committee or pursuant to an exchange of im- whole or in part from an application or portant regulatory information with a foreign government. from an amendment or supplement to (e) After an application has been approved, an application or from any record or the following data and information in the report required under the provisions of NADA file are immediately available for section 512 of the act and § 514.80 or public disclosure unless extraordinary cir- § 510.301 of this chapter of any informa- cumstances are shown: tion obtained from: (1) Investigations as to the safety, ef- * * * * * fectiveness, identity, strength, quality, (2) * * * or purity of the drug, made by the ap- (ii) For an NADA approved after July 1, plicant on the drug, or 1975, a summary of such data and informa- (2) Investigations or experience with tion prepared in one of the following two al- the product that is the subject of the ternative ways shall be publicly released application, or any related product, when the application is approved. available to the applicant from any source if such information is pertinent * * * * * to an evaluation of the safety, effectiveness, identity, strength, quality, or § 514.12 Confidentiality of data and in- purity of the drug, when such omission formation in an investigational new animal drug notice. would bias an evaluation of the safety or effectiveness of the product. (a) The existence of an INAD notice (c) Any nonclinical laboratory study will not be disclosed by the Food and contained in the application was not Drug Administration unless it has pre- conducted in compliance with the good viously been publicly disclosed or ac- laboratory practice regulations as set knowledged. forth in part 58 of this chapter, and the (b) The availability for public disclo- application fails to include a brief sure of all data and information in an statement of the reason for the non- INAD file shall be handled in accord- compliance. ance with provisions established in § 514.11. [40 FR 13825, Mar. 27, 1975, as amended at 49 FR 7226, Feb. 28, 1984; 50 FR 7517, Feb. 22, § 514.15 Untrue statements in applica- 1985; 68 FR 15365, Mar. 31, 2003] tions. Among the reasons why an applica- Subpart B—Administrative Actions tion for a new animal drug or animal on Applications

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§ 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?

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?

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Purpose 21 CFR Paragraph and Title

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?

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 plete files containing full records of all must establish and maintain indexed information pertinent to safety or ef- and complete files containing full fectiveness of a new animal drug that records of all information pertinent to is received or otherwise obtained by safety or effectiveness of a new animal the nonapplicant. Such records must drug that has not been previously sub- include information from domestic as mitted as part of the NADA or ANADA. well as foreign sources. Such records must include information (2) Each applicant must submit re- from domestic as well as foreign ports of data, studies, and other infor- sources. Each nonapplicant must estab- mation concerning experience with lish and maintain indexed and com- new animal drugs to the Food and Drug

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Administration (FDA) for each ap- of the source of the information. The proved NADA and ANADA, as required applicant (or nonapplicant through the in this section. A nonapplicant must applicant) must submit the report to submit data, studies, and other infor- FDA within 15 working days of first re- mation concerning experience with ceiving the information. The report new animal drugs to the appropriate must be submitted on Form FDA 1932, applicant, as required in this section. and its mailing cover must be plainly The applicant, in turn, must report the marked ‘‘15-Day NADA/ANADA Alert nonapplicant’s data, studies, and other Report.’’ information to FDA. Applicants and (ii) Followup report. The applicant nonapplicants must submit data, stud- must promptly investigate all adverse ies, and other information described in drug events that are the subject of 15- this section from domestic, as well as day NADA/ANADA alert reports. If this foreign sources. investigation reveals significant new (3) FDA reviews the records and re- information, a followup report must be ports required in this section to facili- submitted within 15 working days of tate a determination under section receiving such information. A followup 512(e) of the Federal Food, Drug, and report must be submitted on Form Cosmetic Act (21 U.S.C. 360b(e)) as to FDA 1932, and its mailing cover must whether there may be grounds for sus- be plainly marked ‘‘15-Day NADA/ pending or withdrawing approval of the ANADA Alert Report Followup.’’ The NADA or ANADA. followup report must state the date of (4) The requirements of this section the initial report and provide the addi- also apply to any approved Type A tional information. If additional infor- medicated article. In addition, the re- mation is sought but not obtained quirements contained in § 514.80(b)(1), within 3 months of the initial report, a (b)(2), (b)(4)(iv), and (b)(4)(v) apply to followup report is required describing any approved Type A medicated article the steps taken and why additional in- incorporated in animal feeds. formation was not obtained. (5) The records and reports referred to in this section are in addition to (3) Nonapplicant report. Nonapplicants those required by the current good must forward reports of adverse drug manufacturing practice regulations in experiences to the applicant within 3 parts 211, 225, and 226 of this chapter. working days of first receiving the in- (b) Reporting requirements (1) Three- formation. The applicant must then day NADA/ANADA field alert report. submit the report(s) to FDA as re- This report provides information per- quired in this section. The non- taining to product and manufacturing applicant must maintain records of all defects that may result in serious ad- nonapplicant reports, including the verse drug events. The applicant (or date the nonapplicant received the in- nonapplicant through the applicant) formation concerning adverse drug ex- must submit the report to the appro- periences, the name and address of the priate FDA District Office or local applicant, and a copy of the adverse FDA resident post within 3 working drug experience report including the days of first becoming aware that a de- date such report was submitted to the fect may exist. The information ini- applicant. If the nonapplicant elects to tially may be provided by telephone or also report directly to FDA, the non- other telecommunication means, with applicant should submit the report on prompt written followup using Form Form FDA 1932 within 15 working days FDA 1932 ‘‘Veterinary Adverse Drug of first receiving the information. Reaction, Lack of Effectiveness, Prod- (4) Periodic drug experience report. uct Defect Report.’’ The mailing cover This report must be accompanied by a for these reports must be plainly completed Form FDA 2301 ‘‘Trans- marked ‘‘3-Day NADA/ANADA Field mittal of Periodic Reports and Pro- Alert Report.’’ motional Materials for New Animal (2) Fifteen-day NADA/ANADA alert re- Drugs.’’ It must be submitted every 6 port—(i) Initial report. This report pro- months for the first 2 years following vides information on each serious, un- approval of an NADA or ANADA and expected adverse drug event, regardless yearly thereafter. Reports required by

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this section must contain data and in- them) including clinical trials on safe- formation for the full reporting period. ty and effectiveness, clinical trials on The 6-month periodic drug experience new uses, and reports of clinical experi- reports must be submitted within 30 ence pertinent to safety conducted by days following the end of the 6-month or otherwise obtained by the applicant. reporting period. The yearly periodic Review articles, papers, and abstracts drug experience reports must be sub- in which the drug is used as a research mitted within 60 days of the anniver- tool, promotional articles, press clip- sary date of the approval of the NADA pings, and papers that do not contain or ANADA. Any previously submitted tabulations or summaries of original information contained in the report data are not required to be reported. must be identified as such. For yearly (C) Descriptions of completed clinical (annual) periodic drug experience re- trials conducted by or for the applicant ports, the applicant may petition FDA must be submitted no later than 1 year to change the date of submission or fre- after completion of research. Sup- quency of reporting, and after approval porting information is not to be re- of such petition, file such reports on ported. the new filing date or at the new re- (iv) Adverse drug experiences. (A) porting frequency. Also, FDA may re- Product/manufacturing defects and ad- quire a report at different times or verse drug experiences not previously more frequently. The periodic drug ex- reported under § 514.80(b)(1) and (b)(2) perience report must contain the fol- must be reported individually on Form lowing: FDA 1932. (i) Distribution data. Information (B) Reports of adverse drug experi- about the distribution of each new ani- ences in the literature must be noted mal drug product, including informa- in the periodic drug experience report. tion on any distributor-labeled prod- A bibliography of pertinent references uct. This information must include the must be included with the report. Upon total number of distributed units of FDA’s request, the applicant must pro- each size, strength, or potency (e.g., vide a full text copy of these publica- 100,000 bottles of 100 5-milligram tab- tions. lets; 50,000 10-milliliter vials of 5-per- (C) Reports of previously not re- cent solution). This information must ported adverse drug experiences that be presented in two categories: Quan- occur in postapproval studies must be tities distributed domestically and reported separately from other experi- quantities exported. ences in the periodic drug experience (ii) Labeling. Applicant and dis- report and clearly marked or high- tributor current package labeling, in- lighted. cluding package inserts (if any). For (v) Summary report of increased fre- large-size package labeling or large quency of adverse drug experience. The shipping cartons, a representative copy applicant must periodically review the must be submitted (e.g., a photocopy of incidence of reports of adverse drug ex- pertinent areas of large feed bags). A periences to determine if there has summary of any changes in labeling been an increased frequency of serious 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,

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time period comparisons in deter- (2) That the distributor will dis- mining increased frequency, references tribute the new animal drug only under to any previously submitted Form FDA the approved labeling, 1932, the method of analysis, and the (3) That the distributor will promote interpretation of the results. The sum- the product only for use under the con- maries must be submitted in a separate ditions stated in the approved labeling, section within the periodic drug experi- (4) That the distributor will adhere ence report. to the records and reports require- (5) Other reporting—(i) Special drug ex- ments of this section, and perience report. Upon written request, (5) That the distributor is regularly FDA may require that the applicant and lawfully engaged in the distribu- submit a report required under § 514.80 tion or dispensing of prescription prod- at different times or more frequently ucts if the product is a prescription than the timeframes stated in § 514.80. new animal drug. (ii) Advertisements and promotional la- (c) Multiple applications. Whenever an beling. The applicant must submit at applicant is required to submit a peri- the time of initial dissemination one odic drug experience report under the set of specimens of mailing pieces and provisions of § 514.80(b)(4) with respect other labeling for prescription and to more than one approved NADA or over-the-counter new animal drugs. ANADA for preparations containing For prescription new animal drugs, the the same new animal drug so that the applicant must also submit one set of same information is required to be re- specimens of any advertisement at the ported for more than one application, time of initial publication or broad- the applicant may elect to submit as a cast. Mailing pieces and labeling depart of the report for one such applica- signed to contain product samples tion (the primary application) all the must be complete except that product information common to such applications in lieu of reporting separately samples may be omitted. Each submis- and repetitively on each. If the appli- sion of promotional labeling or adver- cant elects to do this, the applicant tisements must be accompanied by a must do the following: completed Form FDA 2301. (1) State when a report applies to (iii) At the Distributor’s statement. multiple applications and identify all time of initial distribution of a new related applications for which the re- animal drug product by a distributor, port is submitted by NADA or ANADA the applicant must submit a special number. drug experience report accompanied by (2) Ensure that the primary applica- a completed Form FDA 2301 containing tion contains a list of the NADA or the following: ANADA numbers of all related applica- (A) The distributor’s current product tions. labeling. (3) Submit a completed Form FDA (1) The distributor’s labeling must be 2301 to the primary application and identical to that in the approved each related application with reference NADA/ANADA except for a different to the primary application by NADA/ and suitable proprietary name (if used) ANADA number and submission date 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

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by a completed Form FDA 2301 agency shall give the applicant notice ‘‘Transmittal of Periodic Reports and and opportunity for hearing, as pro- Promotional Material for New Animal vided in § 514.200, on the question of Drugs,’’ in accordance with directions whether to withdraw approval of the provided on the forms. Computer-gen- application. erated equivalents of Form FDA 1932 or (i) Disclaimer. Any report or informa- Form FDA 2301, approved by FDA be- tion submitted under this section and fore use, may be used. Form FDA 1932 any release of that report or informa- and Form FDA 2301 may be obtained on tion by FDA will be without prejudice the Internet at http://www.fda.gov/cvm/ and does not necessarily reflect a conforms/forms.html, by telephoning the Di- clusion that the report or information vision of Surveillance (HFV–210), or by constitutes an admission that the drug submitting a written request to the fol- caused or contributed to an adverse lowing address: Food and Drug Admin- event. A person need not admit, and istration, Center for Veterinary Medi- may deny, that the report or informa- cine, Division of Surveillance (HFV– tion constitutes an admission that a 210), 7500 Standish Pl., Rockville, MD drug caused or contributed to an ad- 20855–2764. verse event. (e) Records to be maintained. The applicants and nonapplicants must main- [68 FR 15365, Mar. 31, 2003] tain records and reports of all information required by this section for a pe- § 514.100 Evaluation and comment on riod of 5 years after the date of submis- applications. sion. (a) After the filed application has (f) Access to records and reports. The been evaluated, the applicant will be applicant and nonapplicant must, upon furnished written comment on any ap- request from any authorized FDA offi- parent deficiencies in the application. cer or employee, at all reasonable (b) When the description of the meth- times, permit such officer or employee ods used in, and the facilities and con- to have access to copy and to verify all trols used for, the manufacture, proc- such required records and reports. essing, and packing of such new animal (g) Mailing addresses. Completed 15- drug appears adequate on its face, but day alert reports, periodic drug experi- it is not feasible to reach a conclusion ence reports, and special drug experi- as to the safety and effectiveness of the ence reports must be submitted to the new animal drug solely from consider- following address: Food and Drug Ad- ation of this description, the applicant ministration, Center for Veterinary may be notified that an establishment Medicine, Document Control Unit inspection is required to verify their (HFV–199), 7500 Standish Pl., Rockville, MD 20855–2764. Three-day alert reports adequacy. must be submitted to the appropriate (c) A request for samples of a new FDA district office or local FDA resi- animal drug or any edible tissues and dent post. Addresses for district offices byproducts of animals treated with and resident posts may be obtained such a drug, shall specify the quantity from the Internet at http://www.fda.gov deemed adequate to permit tests of an- (click on ‘‘Contact FDA,’’ then ‘‘FDA alytical methods to determine their Field Offices’’). adequacy for regulatory purposes. The (h) Withdrawal of approval. If FDA request should be made as early in the finds that the applicant has failed to 180-day period as possible to assure establish the required records, or has timely completion. The date used for failed to maintain those records, or computing the 180-day limit for the failed to make the required reports, or purposes of section 512(c) of the act has refused access to an authorized shall be moved forward 1 day for each FDA officer or employee to copy or to day after the mailing date of the re- verify such records or reports, FDA quest until all of the requested samples may withdraw approval of the applica- are received. If the samples are not re- tion to which such records or reports ceived within 90 days after the request, relate. If FDA determines that with- the application will be considered withdrawal of the approval is necessary, the drawn without prejudice.

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(d) The information contained in an inspect the facilities, controls, and application may be insufficient to de- records pertinent to the application. termine whether a new animal drug is (f) On the basis of preliminary con- safe or effective in use if it fails to in- sideration of an application or supple- clude (among other things) a statement mental application containing type- showing whether such drug is to be written or other draft labeling in lieu limited to prescription sale and exempt of final printed labeling, an applicant under section 502(f) of the act from the may be informed that such application requirement that its labeling bear ade- is approvable when satisfactory final quate directions for lay use. If such printed labeling identical in content to drug is to be exempt, the information such draft copy is submitted. may also be insufficient if: (g) When an application has been (1) The specimen labeling proposed found incomplete on the basis of a need fails to bear adequate information for for the kind of information described professional use including indications, in § 514.6, such application shall be con- effects, dosages, routes, methods, and sidered withdrawn without prejudice to frequency and duration of administra- future filing on the date of issuance of tion and any relevant hazards, contra- the letter citing the inadequacies con- indications, side effects, and pre- tained in the application, unless within cautions under which practitioners li- 30 days the sponsor chooses to avail censed by law to administer such drug himself of the opportunity for hearing can use the drug for the purposes for as prescribed by § 514.111. which it is intended, including all purposes for which it is to be advertised, § 514.105 Approval of applications. or represented, in accordance with (a) The Commissioner shall forward § 201.105 of this chapter, and informa- for publication in the FEDERAL REG- tion concerning hazards, contraindica- ISTER a regulation prescribing the con- tions, side effects, and precautions rel- ditions under which the new animal evant with respect to any uses for drug may be used, including the name which such drug is to be prescribed. and address of the applicant; the condi- (2) The application fails to show that tions and indications for use covered the labeling and advertising of such by the application; any tolerance, drug will offer the drug for use only withdrawal period, or other use restric- under those conditions for which it is tions; any tolerance required for the offered in the labeling that is part of new animal drug substance or its me- the application. tabolites in edible products of food-pro- (3) The application fails to show that ducing animals; and, if such new ani- all labeling that furnishes or purports mal drug is intended for use in animal to furnish information for professional feed, appropriate purposes and condi- use of such drug will contain, in the tions of use (including special labeling same language and emphasis, the infor- requirements) applicable to any animal mation for use including indications, feed; and such other information the effects, dosages, routes, methods, and Commissioner deems necessary to as- frequency and duration of administra- sure safe and effective use. tion and any relevant warnings, haz- (b) He shall notify the applicant by ards, contraindications, side effects, sending him a copy of the proposed and precautions, which is contained in publication as described in paragraph the labeling that is part of the applica- (a)(1) of this section. tion in accordance with § 201.105 of this [40 FR 13825, Mar. 27, 1975, as amended at 51 chapter. FR 7392, Mar. 3, 1986; 64 FR 63203, Nov. 19, (e) The information contained in an 1999] application will be considered insufficient to determine whether a new ani- § 514.106 Approval of supplemental ap- mal drug is safe and effective for use plications. when there is a refusal or failure upon (a) Within 180 days after a supple- written notice to furnish inspectors au- ment to an approved application is thorized by the Food and Drug Admin- filed pursuant to § 514.8, the Commis- istration an adequate opportunity to sioner shall approve the supplemental

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application in accordance with proce- (i) A change in the active ingredient dures set forth in § 514.105(a)(1) and (2) concentration or composition of the if he/she determines that the applica- final product. tion satisfies the requirements of ap- (ii) A change in quality, purity, plicable statutory provisions and regu- strength, and identity specifications of lations. the active or inactive ingredients. (b) The Commissioner will assign a (iii) A change in dose (amount of supplemental application to its proper drug administered per dose). category to ensure processing of the (iv) A change in the treatment regi- application. men (schedule of dosing). (1) Category I. Supplements that ordi- (v) Addition of a new therapeutic narily do not require a reevaluation of claim to the approved uses of the prod- any of the safety or effectiveness data uct. in the parent application. Category I (vi) Addition of a new or revised ani- supplements include the following: mal production claim. (i) A corporate change that alters the (vii) Addition of a new species. identity or address of the sponsor of (viii) A change in the prescription or the new animal drug application over-the-counter status of a drug prod- (NADA). uct. (ii) The sale, purchase, or construc- (ix) A change in statements regard- tion of manufacturing facilities. ing side effects, warnings, precautions, (iii) The sale or purchase of an and contraindications, except the addi- NADA. tion of approved statements to con- (iv) A change in container, container tainer, package, and promotional label- style, shape, size, or components. ing, and prescription drug advertising. (v) A change in approved labeling (x) A change in the drug withdrawal (color, style, format, addition, dele- period prior to slaughter or in the milk tion, or revision of certain statements, discard time. e.g., trade name, storage, expiration (xi) A change in the tolerance for dates, etc). drug residues. (vi) A change in promotional mate- (xii) A change in analytical methods rial for a prescription new animal drug for drug residues. not exempted by § 514.8(c)(2)(i)(C)(1) (xiii) A revised method of synthesis through (c)(2)(i)(C)(3). or fermentation of the new drug sub- (vii) Changes in manufacturing proc- stance. esses that do not alter the method of (xiv) Updating or changes in the manufacture or change the final dosage manufacturing process of the new drug form. substance and/or final dosage form (viii) A change in bulk drug ship- (other than a change in equipment that ments. does not alter the method of manufac- (ix) A change in an analytical meth- ture of a new animal drug, or a change od or control procedures that do not from one commercial batch size to an- alter the approved standards. other without any change in manufac- (x) A change in an expiration date. turing procedure), or changes in the (xi) Addition of an alternate manu- methods, facilities, or controls used for facturer, repackager, or relabeler of the manufacture, processing, pack- the drug product. aging, or holding of the new animal (xii) Addition of an alternate supplier drug (other than use of an establish- of the new drug substance. ment not covered by the approval that (xiii) A change permitted in advance is in effect) that give increased assur- of approval as described under ance that the drug will have the char- § 514.8(b)(3). acteristics of identity, strength, qual- (2) Category II. Supplements that may ity, and purity which it purports or is require a reevaluation of certain safety represented to possess. or effectiveness data in the parent ap- [55 FR 46052, Nov. 1, 1990; 55 FR 49973, Dec. 3, plication. Category II supplements in- 1990; 56 FR 12422, Mar. 25, 1991; 71 FR 74785, clude the following: Dec. 13, 2006]

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§ 514.110 Reasons for refusing to file (10) The applicant fails to submit a applications. complete environmental assessment (a) The date of receipt of an applica- under § 25.40 of this chapter or fails to tion for a new animal drug shall be the provide sufficient information to estab- date on which the application shall be lish that the requested action is sub- deemed to be filed. ject to categorical exclusion under (b) An application for a new animal § 25.30 or § 25.33 of this chapter. drug shall not be considered acceptable (c) If an application is determined for filing for any of the following rea- not to be acceptable for filing, the ap- sons: plicant shall be notified within 30 days (1) It does not contain complete and of receipt of the application and shall accurate English translations of any be given the reasons therefore. pertinent part in a foreign language. (d) If the applicant disputes the find- (2) Fewer than three copies are sub- ings that his application is not accept- mitted. able for filing, he may make written (3) It is incomplete on its face in that request that the application be filed it is not properly organized and in- over protest, in which case it will be dexed. filed as of the day originally received. (4) On its face the information concerning required matter is so inad- [40 FR 13825, Mar. 27, 1975, as amended at 50 FR 7517, Feb. 22, 1985; 50 FR 16668, Apr. 26, equate that the application is clearly 1985; 62 FR 40600, July 29, 1997] not approvable. (5) The new animal drug is to be man- § 514.111 Refusal to approve an appli- ufactured, prepared, propagated, com- cation. pounded, or processed in whole or in part in any State in an establishment (a) The Commissioner shall, within that has not been registered or exempt- 180 days after the filing of the applica- ed from registration under the provi- tion, inform the applicant in writing of sions of section 510 of the act. his intention to issue a notice of oppor- (6) The sponsor does not reside or tunity for a hearing on a proposal to maintain a place of business within the refuse to approve the application, if the United States and the application has Commissioner determines upon the not been countersigned by an attorney, basis of the application, or upon the agent, or other representative of the basis of other information before him applicant, which representative resides with respect to a new animal drug, in the United States and has been duly that: authorized to act on behalf of the ap- (1) The reports of investigations re- plicant and to receive communications quired to be submitted pursuant to sec- on all matters pertaining to the appli- tion 512(b) of the act do not include cation. adequate tests by all methods reason- (7) The new animal drug is a drug ably applicable to show whether or not subject to licensing under the animal such drug is safe for use under the con- virus, serum, and toxin law of March 4, ditions prescribed, recommended, or 1913 (37 Stat. 832; 21 U.S.C. 151 et seq. ). suggested in the proposed labeling Such applications will be referred to thereof; or the U.S. Department of Agriculture for (2) The results of such tests show action. that such drug is unsafe for use under (8) It fails to include, with respect to such conditions or do not show that each nonclinical laboratory study con- such drug is safe for use under such tained in the application, either a conditions; or statement that the study was con- (3) The methods used in and the fa- ducted in compliance with the good cilities and controls used for the manu- laboratory practice regulations set facture, processing, and packing of forth in part 58 of this chapter, or, if such drug are inadequate to preserve the study was not conducted in compli- its identity, strength, quality, and pu- ance with such regulations, a brief rity; or statement of the reasons for the non- (4) Upon the basis of the information compliance. submitted to the Food and Drug Ad- (9) [Reserved] ministration as part of the application,

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or upon the basis of any other informa- (ii) No residue of such drug will be tion before it with respect to such found (by methods of examination pre- drug, it has insufficient information to scribed or approved by the Commis- determine whether such drug is safe for sioner by regulations) in any edible use under such conditions. In making portion of such animal after slaughter this determination the Commissioner or in any food yielded by, or derived shall consider, among other relevant from the living animals. factors: (9) The applicant fails to submit an (i) The probable consumption of such adequate environmental assessment drug and of any substance formed in or under § 25.40 of this chapter or fails to on food because of the use of such drug; provide sufficient information to estab- (ii) The cumulative effect on man or lish that the requested action is sub- animal of such drug, taking into ac- ject to categorical exclusion under count any chemically or pharmacologi- § 25.30 or § 25.33 of this chapter. cally related substances; (10) The drug fails to satisfy the re- (iii) Safety factors which, in the quirements of subpart E of part 500 of opinion of experts qualified by sci- this chapter. entific training and experience to (11) Any nonclinical laboratory study evaluate the safety of such drugs, are that is described in the application and appropriate for the use of animal ex- that is essential to show that the drug perimentation data; and is safe for use under the conditions pre- (iv) Whether the conditions of use scribed, recommended, or suggested in prescribed, recommended, or suggested its proposed labeling, was not con- in the proposed labeling are reasonably certain to be followed in practice; or ducted in compliance with the good laboratory practice regulations as set (5) Evaluated on the basis of information submitted as part of the applica- forth in part 58 of this chapter and no tion and any other information before reason for the noncompliance is pro- the Food and Drug Administration vided or, if it is, the differences be- with respect to such drug, there is lack tween the practices used in conducting of substantial evidence as defined in the study and the good laboratory § 514.4. practice regulations do not support the (6) Failure to include an appropriate validity of the study. proposed tolerance for residues in edi- (b) The Commissioner, as provided in ble products derived from animals or a § 514.200 of this chapter, shall expedi- withdrawal period or other restrictions tiously notify the applicant of an op- for use of such drug if any tolerance or portunity for a hearing on the question withdrawal period or other restrictions of whether such application is approv- for use are required in order to assure able, unless by the 30th day following that the edible products derived from the date of issuance of the letter in- animals treated with such drug will be forming the applicant of the intention safe. to issue a notice of opportunity for a (7) Based on a fair evaluation of all hearing the applicant: material facts, the labeling is false or (1) Withdraws the application; or misleading in any particular; or (2) Waives the opportunity for a hear- (8) Such drug induces cancer when in- ing; or gested by man or animal or, after ap- (3) Agrees with the Commissioner on propriate tests for evaluation of the an additional period to precede safety of such drug, induces cancer in issuance of such notice of hearing. man or animal, except that this sub- paragraph shall not apply with respect [40 FR 13825, Mar. 27, 1975, as amended at 43 to such drug if the Commissioner finds FR 22675, May 26, 1978; 44 FR 16007, Mar. 16, that, under the conditions of use speci- 1979; 50 FR 7517, Feb. 22, 1985; 50 FR 16668, fied in proposed labeling and reason- Apr. 26, 1985; 52 FR 49588, Dec. 31, 1987; 54 FR ably certain to be followed in practice: 18280, Apr. 28, 1989; 62 FR 40600, July 29, 1997; (i) Such drug will not adversely af- 63 FR 10770, Mar. 5, 1998; 64 FR 40757, July 28, fect the animal for which it is in- 1999; 64 FR 63204, Nov. 19, 1999] tended; and

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§ 514.115 Withdrawal of approval of (iii) On the basis of new information applications. before him with respect to such drug, (a) The Secretary may suspend ap- evaluated together with the evidence proval of an application approved pur- available to him when the application suant to section 512(c) of the act and was approved, there is a lack of sub- give the applicant prompt notice of his stantial evidence that such drug will action and afford the applicant the op- have the effect it purports or is rep- portunity for an expedited hearing on a resented to have under the conditions finding that there is an imminent haz- of use prescribed, recommended, or ard to the health of man or of the ani- suggested in the labeling thereof. mals for which such new animal drug (4) That any nonclinical laboratory or animal feed is intended. study that is described in the applica- (b) The Commissioner shall notify in tion and that is essential to show that writing the person holding an applica- the drug is safe for use under the condition approved pursuant to section tions prescribed, recommended, or sug- 512(c) of the act and afford an oppor- gested in its proposed labeling, was not tunity for a hearing on a proposal to conducted in compliance with the good withdraw approval of such application laboratory practice regulations as set if he finds: forth in part 58 of this chapter and no (1) That the application contains any reason for the noncompliance is pro- untrue statement of a material fact; or vided or, if it is, the differences be- (2) That the applicant has made any tween the practices used in conducting changes from the standpoint of safety the study and the good laboratory or effectiveness beyond the variations practice regulations do not support the provided for in the application unless validity of the study. he has supplemented the application by (c) The Commissioner may notify in filing with the Secretary adequate in- writing the person holding an applica- formation respecting all such changes tion approved pursuant to section and unless there is in effect an ap- 512(c) of the act and afford an oppor- proval of the supplemental application, tunity for a hearing on a proposal to or such changes are those for which withdraw approval of such application written authorization or approval is if he finds: not required as provided for in § 514.8. (1) That the applicant has failed to The supplemental application shall be establish a system for maintaining retreated in the same manner as the quired records, or has repeatedly or de- original application. liberately failed to maintain such (3) That in the case of an application records or to make required reports in for use of a new animal drug approved accordance with a regulation or order or deemed approved pursuant to sec- under section 512(l)(1) of the act, or the tion 512(c) of the act: applicant has refused to permit access (i) Experience or scientific data show to, or copying, or verification of, such that such drug is unsafe for use under records as required by section 512(l)(2) the conditions of use upon the basis of of the act; or which the application was approved; or (2) That on the basis of new informa- (ii) New evidence not contained in tion before him evaluated together such application or not available to the with the evidence before him when the Secretary until after such application application was approved, the methods was approved, or tests by new methods, used in, or the facilities and controls 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

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application was approved, the labeling trolled studies are required to estab- of such drug, based on a fair evaluation lish, by substantial evidence, that a of all material facts, is false or mis- new animal drug is effective. The char- leading in any particular and was not acteristics described in paragraph (b) corrected within a reasonable time of this section have been developed after receipt of written notice from the over a period of years and are generally Secretary specifying the matter com- recognized as the essentials of an ade- plained of. quate and well-controlled study. Well (d) Approval of an application pursu- controlled, as used in the phrase ade- ant to section 512(c) of the act will be quate and well controlled, emphasizes withdrawn on the basis of a request for an important aspect of adequacy. The its withdrawal submitted in writing by Food and Drug Administration (FDA) a person holding an approved new ani- considers these characteristics in de- mal drug application on the grounds termining whether a study is adequate that the drug subject to such applica- and well controlled for purposes of section is no longer being marketed and tion 512 of the Federal Food, Drug, and information is included in support of Cosmetic Act (the act) (21 U.S.C. 360b). this finding, provided none of the con- Adequate and well-controlled studies, ditions cited in paragraphs (a), (b), and in addition to providing a basis for de- (c) of this section pertain to the sub- termining whether a new animal drug ject drug. A written request for such is effective, may also be relied upon to withdrawal shall be construed as a support target animal safety. The re- waiver of the opportunity for a hearing port of an adequate and well-controlled as otherwise provided for in this sec- study should provide sufficient details tion. Withdrawal of approval of an ap- of study design, conduct, and analysis plication under the provisions of this to allow critical evaluation and a de- paragraph shall be without prejudice. termination of whether the character- (e) On the basis of the withdrawal of istics of an adequate and well-con- approval of an application for a new trolled study are present. animal drug approved pursuant to sec- (b) Characteristics. An adequate and tion 512(c) of the act, the regulation well-controlled study has the following published pursuant to section 512(i) of characteristics: the act covering the conditions of use (1) The protocol for the study (proof such drug as provided for in the ap- tocol) and the report of the study re- plication shall be revoked. sults (study report) must include a [40 FR 13825, Mar. 27, 1975, as amended at 50 clear statement of the study objec- FR 7517, Feb. 22, 1985; 64 FR 63204, Nov. 19, tive(s). 1999] (2) The study is conducted in accordance with an appropriate standard of § 514.116 Notice of withdrawal of ap- conduct that addresses, among other proval of application. issues, study conduct, study personnel, When an approval of an application study facilities, and study documenta- submitted pursuant to section 512 of tion. The protocol contains a state- the act is withdrawn by the Commis- ment acknowledging the applicability sioner, he will give appropriate public of, and intention to follow, a standard notice of such action by publication in of conduct acceptable to FDA. The the FEDERAL REGISTER. study report contains a statement describing adherence to the standard. § 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,

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to permit meaningful evaluations of vious placebo-controlled studies of the and comparisons with other studies active control. conducted with the new animal drug. (iv) Historical control. The results of The physical form of a new animal treatment with the new animal drug drug includes the formulation and are quantitatively compared with expe- physical characterization (including rience historically derived from the delivery systems thereof, if any) of the adequately documented natural history new animal drug as presented to the of the disease or condition, or with a animal. The protocol and study report regimen (therapeutic, diagnostic, pro- must include an identification number phylactic) whose effectiveness is estab- which can be correlated with the spe- lished, in comparable animals. Because cific formulation and production proc- historical control populations usually ess used to manufacture the new ani- cannot be as well assessed with respect mal drug used in the study. to pertinent variables as can concur- (4) The study uses a design that per- rent control populations, historical mits a valid comparison with one or control designs are usually reserved for more controls to provide a quantitative special circumstances. Examples in- evaluation of drug effects. The protocol clude studies in which the effect of the and the study report must describe the new animal drug is self-evident or stud- precise nature of the study design, e.g., ies of diseases with high and predict- duration of treatment periods, whether able mortality, or signs and symptoms treatments are parallel, sequential, or of predictable duration or severity, or, crossover, and the determination of in the case of prophylaxis, predictable sample size. Within the broad range of morbidity. studies conducted to support a determination of the effectiveness of a new (5) The study uses a method of select- animal drug, certain of the controls ing animals that provides adequate as- listed below would be appropriate and surances that the animals are suitable preferred depending on the study con- for the purposes of the study. For ex- ducted: ample, the animals can reasonably be (i) Placebo concurrent control. The new expected to have animal production animal drug is compared with an inac- characteristics typical of the class(es) tive preparation designed to resemble of animals for which the new animal the new animal drug as far as possible. drug is intended, there is adequate as- (ii) Untreated concurrent control. The surance that the animals have the dis- new animal drug is compared with the ease or condition being studied, or, in absence of any treatment. The use of the case of prophylactic agents, evi- this control may be appropriate when dence of susceptibility and exposure to objective measurements of effective- the condition against which prophy- ness, not subject to observer bias, are laxis is desired has been provided. The available. protocol and the study report describe (iii) Active treatment concurrent con- the method of selecting animals for the trol. The new animal drug is compared study. with known effective therapy. The use (6) The study uses a method to assign of this control is appropriate when the a treatment or a control to each exper- use of a placebo control or of an un- imental unit of animals that is random treated concurrent control would un- and minimizes bias. Experimental reasonably compromise the welfare of units of animals are groups of animals the animals. Similarity of the new ani- that are comparable with respect to mal drug and the active control drug pertinent variables such as age, sex, can mean either that both drugs were class of animal, severity of disease, du- effective or that neither was effective. ration of disease, dietary regimen, The study report should assess the level of animal production, and use of ability of the study to have detected a drugs or therapy other than the new difference between treatments. The animal drug. The protocol and the evaluation of the study should explain study report describe the method of as- why the new animal drugs should be signment of animals to an experi- considered effective in the study, for mental unit to account for pertinent example, by reference to results in pre- variables and method of assignment of

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a treatment or a control to the experi- use an appropriate control that per- mental units. When the effect of such mits comparison, employ procedures to variables is accounted for by an appro- minimize bias, and have the character- priate design, and when, within the istics generally described in paragraph same animal, effects due to the test (b) of this section. However, because drug can be obtained free of the effects field studies are conducted under field of such variables, the same animal may conditions, it is recognized that the be used for both the test drug and the level of control over some study condi- control using the controls set forth in tions need not or should not be the paragraph (b)(4) of this section. same as the level of control in labora- (7) The study uses methods to mini- tory studies. While not all conditions mize bias on the part of observers and relating to a field study need to be or analysts of the data that are adequate should be controlled, observations of to prevent undue influences on the re- the conditions under which the new sults and interpretation of the study animal drug is tested shall be recorded data. The protocol and study report ex- in sufficient detail to permit evalua- plain the methods of observation and recording of the animal response vari- tion of the study. Adequate and well- ables and document the methods, such controlled field studies shall balance as ‘‘blinding’’ or ‘‘masking,’’ used in the need to control study conditions the study for excluding or minimizing with the need to observe the true effect bias in the observations. of the new animal drug under closely (8) The study uses methods to assess approximated actual use conditions. animal response that are well defined (d) Waiver. The Director of the Center and reliable. The protocol and study re- for Veterinary Medicine (the Director) port describe the methods for con- may, on the Director’s own initiative ducting the study, including any appro- or on the petition of an interested per- priate analytical and statistical meth- son, waive in whole or in part any of ods, used to collect and analyze the the criteria in paragraph (b) of this sec- data resulting from the conduct of the tion with respect to a specific study. A study, describe the criteria used to as- petition for a waiver is required to set sess response, and, when appropriate, forth clearly and concisely the specific justify the selection of the methods to criteria from which waiver is sought, assess animal response. why the criteria are not reasonably ap- (9) There is an analysis and evalua- plicable to the particular study, what tion of the results of the study in ac- alternative procedures, if any, are to cord with the protocol adequate to as- be, or have been employed, and what sess the effects of the new animal drug. results have been obtained. The peti- The study report evaluates the meth- tion is also required to state why the ods used to conduct, and presents and studies so conducted will yield, or have evaluates the results of, the study as to yielded, substantial evidence of effec- their adequacy to assess the effects of tiveness, notwithstanding nonconform- the new animal drug. This evaluation ance with the criteria for which waiver of the results of the study assesses, is requested. among other items, the comparability of treatment and control groups with (e) Uncontrolled studies. Uncontrolled respect to pertinent variables and the studies or partially controlled studies effects of any interim analyses per- are not acceptable as the sole basis for formed. the approval of claims of effectiveness (c) Field studies. (1) Field conditions or target animal safety. Such studies, as used in this section refers to condi- carefully conducted and documented, tions which closely approximate the may provide corroborative support of conditions under which the new animal adequate and well-controlled studies drug, if approved, is intended to be ap- regarding effectiveness and may yield plied or administered. valuable data regarding safety of the (2) Studies of a new animal drug con- new animal drug. Such studies will be ducted under field conditions shall, considered on their merits in light of consistent with generally recognized the characteristics listed here. Isolated scientific principles and procedures, case reports, random experience, and

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reports lacking the details which per- not to avail himself of the opportunity mit scientific evaluation will not be for the hearing, and the Commissioner considered. without further notice may enter a [63 FR 10770, Mar. 5, 1998] final order. (c) If the applicant elects to avail § 514.120 Revocation of order refusing himself of the opportunity for a hear- to approve an application or sus- ing, he is required to file a written ap- pending or withdrawing approval pearance requesting the hearing within of an application. 30 days after the publication of the no- The Commissioner, upon his own ini- tice, giving the reason why the applica- tiative or upon request of an applicant tion should not be refused or should stating reasonable grounds therefor not be withdrawn, together with a and if he finds that the facts so require, well-organized and full-factual analysis may issue an order approving an appli- of the clinical and other investiga- cation that previously has had its ap- tional data he is prepared to prove in proval refused, suspended, or with- support of his opposition to the Com- drawn. missioner’s proposal. A request for a § 514.121 Service of notices and orders. hearing may not rest upon mere allegations or denials, but must set forth spe- All notices and orders under this sub- cific facts showing there is a genuine chapter E and section 512 of the act and substantial issue of fact that re- pertaining to new animal drug applica- quires a hearing. When it clearly ap- tions shall be served: pears from the data in the application (a) In person by any officer or em- and from the reasons and a factual ployee of the Department designated analysis in the request for the hearing by the Commissioner; or (b) By mailing the order by certified that no genuine and substantial issue mail addressed to the applicant or re- of fact precludes the refusal to approve spondent at his last known address in the application or the withdrawal of the records of the Food and Drug Ad- approval of the application (for exam- ministration. ple, no adequate and well-controlled clinical investigations to support the claims of effectiveness have been iden- Subpart C—Hearing Procedures tified), the Commissioner will enter an § 514.200 Contents of notice of oppor- order on this data, stating his findings tunity for a hearing. and conclusions. If a hearing is re- (a) The notice to the applicant of op- quested and is justified by the appli- portunity for a hearing on a proposal cant’s response to the notice of oppor- by the Commissioner to refuse to ap- tunity for a hearing, the issues will be prove an application or to withdraw defined, an Administrative Law Judge the approval of an application will will be named, and he shall issue a specify the grounds upon which he pro- written notice of the time and place at poses to issue his order. On request of which the hearing will commence. In the applicant, the Commissioner will the case of denial of approval, such explain the reasons for his action. The time shall be not more than 90 days notice of opportunity for a hearing will after the expiration of such 30 days un- be published in the FEDERAL REGISTER less the Administrative Law Judge and and will specify that the applicant has the applicant otherwise agree; and, in 30 days after issuance of the notice the case of withdrawal of approval, within which he is required to file a such time shall be as soon as prac- written appearance electing whether: ticable. (1) To avail himself of the oppor- (d) The hearing will be open to the tunity for a hearing; or public; however, if the Commissioner (2) Not to avail himself of the oppor- finds that portions of the application tunity for a hearing. which serve as a basis for the hearing (b) If the applicant fails to file a contain information concerning a written appearance in answer to the method or process entitled to protec- notice of opportunity for hearing, his tion as a trade secret, the part of the failure will be construed as an election hearing involving such portions will

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not be public, unless the respondent so 515.23 Voluntary revocation of medicated specifies in his appearance. feed mill license. 515.24 Notice of revocation of a medicated [40 FR 13825, Mar. 27, 1975, as amended at 43 feed mill license. FR 1941, Jan. 13, 1978] 515.25 Revocation of order refusing to approve a medicated feed mill license appli- § 514.201 Procedures for hearings. cation or suspending or revoking a license. Hearings relating to new animal 515.26 Services of notices and orders. drugs under section 512(d) and (e) of the act shall be governed by part 12 of this Subpart C—Hearing Procedures chapter. 515.30 Contents of notice of opportunity for [64 FR 63204, Nov. 19, 1999] a hearing. 515.31 Procedures for hearings.

Subparts D–E [Reserved] Subpart D—Judicial Review Subpart F—Judicial Review 515.40 Judicial review. AUTHORITY: 21 U.S.C. 360b, 371. § 514.235 Judicial review. SOURCE: 64 FR 63204, Nov. 19, 1999 unless (a) The transcript and record shall be otherwise noted. certified by the Commissioner. In any case in which the Commissioner enters Subpart A—Applications an order without a hearing pursuant to § 314.200(g) of this chapter, the re- § 515.10 Medicated feed mill license quest(s) for hearing together with the applications. data and information submitted and (a) Medicated feed mill license appli- the Commissioner’s findings and con- cations (Forms FDA 3448) may be ob- clusions shall be included in the record tained from the Public Health Service, certified by the Commissioner. Consolidated Forms and Publications (b) Judicial review of an order with- Distribution Center, Washington Com- drawing approval of a new drug appli- merce Center, 3222 Hubbard Rd., Land- cation, whether or not a hearing has over, MD 20785, or electronically from been held, may be sought by a manu- the Center for Veterinary Medicine facturer or distributor of an identical, home page at http://www.fda.gov/cvm. related, or similar drug product, as de- (b) A completed medicated feed mill fined in § 310.6 of this chapter, in a license must contain the following in- United States court of appeals pursu- formation: ant to section 505(h) of the act. (1) The full business name and ad- [42 FR 4717, Jan. 25, 1977] dress of the facility at which the manufacturing is to take place. (2) The facility’s FDA registration PART 515—MEDICATED FEED MILL number as required by section 510 of LICENSE the Federal Food, Drug, and Cosmetic Act (the act). Subpart A—Applications (3) The name, title, and signature of Sec. the responsible individual or individ- 515.10 Medicated feed mill license applica- uals for that facility. tions. (4) A certification that the animal 515.11 Supplemental medicated feed mill li- feeds bearing or containing new animal cense applications. drugs are manufactured and labeled in accordance with the applicable regula- Subpart B—Administrative Actions on tions published under section 512(i) of Licenses the act or in accordance with the index listing published under section 572(e)(2) 515.20 Approval of medicated feed mill license applications. of the act. 515.21 Refusal to approve a medicated feed (5) A certification that the methods mill license application. used in, and the facilities and controls 515.22 Suspension and/or revocation of ap- used for, manufacturing, processing, proval of a medicated feed mill license. packaging, and holding such animal

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feeds conform to current good manu- provides adequate information respect- facturing practice as described in sec- ing the change in ownership and/or tion 501(a)(2)(B) of the act and in part postal address of the facility site, then 225 of this chapter. an authorized employee of the Food (6) A certification that the facility and Drug Administration designated by will establish and maintain all records the Commissioner shall notify the ap- required by regulation or order issued plicant that it is approved by signing under sections 512(m)(5)(A) or and mailing to the applicant a copy of 504(a)(3)(A) of the act, and will permit the Form FDA 3448. Supplemental ap- access to, or copying or verification of plications that do not provide adequate such records. information shall be returned to the (7) A commitment that current ap- applicant and all reasons for the return proved or index listed Type B and/or of the application shall be made known Type C medicated feed labeling for to the applicant. each Type B and/or Type C medicated feed to be manufactured will be in the possession of the feed manufacturing Subpart B—Administrative Actions facility prior to receiving the Type A on Licenses medicated article containing such § 515.20 Approval of medicated feed drug. mill license applications. (8) A commitment to renew registration every year with FDA as required Within 90 days after an application in §§ 207.20 and 207.21 of this chapter. has been filed under § 515.10, if the Com- (c) Applications must be completed, missioner of Food and Drugs (the Com- signed, and submitted to the Division missioner) determines that none of the of Animal Feeds (HFV–220), Center for grounds for denying approval specified Veterinary Medicine, Food and Drug in section 512(m)(3) of the Federal Administration, 7500 Standish Pl., Food, Drug, and Cosmetic Act (the act) Rockville, MD 20855. applies, an authorized employee of the (d) Applications that are facially de- Food and Drug Administration des- ficient will be returned to the appli- ignated by the Commissioner shall no- cant. All reasons for the return of the tify the applicant that it is approved application will be made known to the by signing and mailing to the applicant applicant. a copy of the Form FDA 3448. (e) Upon approval, the original copy of the application will be signed by an § 515.21 Refusal to approve a medi- authorized employee of FDA des- cated feed mill license application. ignated by the Commissioner of Food (a) The Commissioner of Food and and Drugs, and a copy will be returned Drugs (the Commissioner) shall within to the applicant. 90 days, or such additional period as [64 FR 63204, Nov. 19, 1999, as amended at 72 may be agreed upon by the Commis- FR 69121, Dec. 6, 2007] sioner and the applicant, after the filing of an application under § 515.10, in- § 515.11 Supplemental medicated feed form the applicant in writing of his/her mill license applications. intention to issue a notice of oppor- (a) After approval of a medicated feed tunity for a hearing on a proposal to mill license application to manufac- refuse to approve the application, if the ture animal feed, a supplemental appli- Commissioner determines upon the cation shall be submitted for a change basis of the application, on the basis of in ownership and/or a change in mail- a preapproval inspection, or upon the ing address of the facility site. basis of any other information before (b) Each supplemental application him that: should be accompanied by a fully com- (1) The application is incomplete, pleted Form FDA 3448 and include an false, or misleading in any particular; explanation of the change. or (c) Within 30 working days after a (2) The methods used in and the fa- supplemental application has been cilities and controls used for the manu- filed, if the Commissioner of Food and facturing, processing, and packaging of Drugs determines that the application such animal feed are not adequate to

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preserve the identity, strength, qual- tion to contain any untrue statements ity, and purity of the new animal drug of material fact or that would affect therein; or the safety or effectiveness of the ani- (3) The facility manufactures animal mal feeds manufactured at the facility feeds bearing or containing new animal unless the applicant has supplemented drugs in a manner that does not accord the application by filing a supple- with the specifications for manufac- mental application under § 515.11. ture or labels animal feeds bearing or (c) The Commissioner may notify in containing new animal drugs in a man- writing the person holding an applica- ner that does not accord with the con- tion approved under section 512(m)(2) of ditions or indications of use that are the act and afford an opportunity for a published under section 512(i) or hearing on a proposal to revoke ap- 572(e)(2) of the act. proval of such application if the Com- (b) The Commissioner, as provided in missioner finds: § 515.30, shall expeditiously notify the (1) That the applicant has failed to applicant of an opportunity for a hear- establish a system for maintaining re- ing on the question of whether such ap- quired records, or has repeatedly or de- plication is approvable, unless by the liberately failed to maintain such 30th day following the date of issuance records or to make required reports in of the letter informing the applicant of accordance with a regulation or order the intention to issue a notice of op- under sections 512(m)(5)(A) or portunity for a hearing the applicant: 504(a)(3)(A) of the act, or the applicant (1) Withdraws the application; or has refused to permit access to, or (2) Waives the opportunity for a hear- copying, or verification of, such ing; or records as required by sections (3) Agrees with the Commissioner on 512(m)(5)(B) or 504(a)(3)(B) of the act; or an additional period to precede (2) That on the basis of new informa- issuance of such notice of hearing. tion before him, evaluated together [64 FR 63204, Nov. 19, 1999, as amended at 72 with the evidence before him when FR 69121, Dec. 6, 2007] such license was issued, the methods used in, or the facilities and controls § 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. uation of all material facts, is false or (b) The Commissioner of Food and misleading in any particular and was Drugs (the Commissioner) shall notify not corrected within a reasonable time in writing the person holding an appli- after receipt of written notice from the cation approved under section 512(m)(2) Commissioner specifying the matter of the act and afford an opportunity for complained of; or a hearing on a proposal to revoke ap- (4) That on the basis of new informa- proval of such application if the Com- tion before him, evaluated together missioner finds: with the evidence before him when (1) That the application contains any such license was issued, the facility has untrue statement of a material fact; or manufactured, processed, packed, or (2) That the applicant has made any held animal feed bearing or containing changes that would cause the applica- a new animal drug adulterated under

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section 501(a)(6) of the act, and the fa- taining to medicated feed mill licenses cility did not discontinue the manufac- shall be served: ture, processing, packing, or holding of (a) In person by any officer or em- such animal feed within a reasonable ployee of the Department of Health and time after receipt of written notice Human Services designated by the from the Commissioner specifying the Commissioner of Food and Drugs; or matter complained of. (b) By mailing the order by certified mail addressed to the applicant or re- § 515.23 Voluntary revocation of medi- spondent at the applicant or respond- cated feed mill license. ent’s last known address in the records A license issued under section of the Food and Drug Administration. 512(m)(2) of the Federal Food, Drug, and Cosmetic Act (the act) will be re- Subpart C—Hearing Procedures voked on the basis of a request for its revocation submitted in writing by a § 515.30 Contents of notice of oppor- responsible individual holding such li- tunity for a hearing. cense on the grounds that the facility (a) The notice to the applicant of op- no longer manufactures any animal portunity for a hearing on a proposal feed covered under § 558.4(b) of this by the Commissioner of Food and chapter. A written request for such revocation shall be construed as a Drugs (the Commissioner) to refuse to waiver of the opportunity for a hearing approve a medicated feed mill license as otherwise provided for in this sec- application or to revoke the approval tion. Revocation of approval of a medi- of a medicated feed mill license will cated feed mill license under the provi- specify the grounds upon which the sions of this paragraph shall be with- Commissioner proposes to issue this out prejudice. order. On request of the applicant, the Commissioner will explain the reasons § 515.24 Notice of revocation of a medi- for the action. The notice of oppor- cated feed mill license. tunity for a hearing will be published in the FEDERAL REGISTER and will When a license approved under sec- specify that the applicant has 30 days tion 512 of the Federal Food, Drug, and after issuance of the notice within Cosmetic Act (the act) is revoked by the Commissioner of Food and Drugs which the Commissioner is required to (the Commissioner), the Commissioner file a written appearance electing will give appropriate public notice of whether: such action by publication in the FED- (1) To avail himself of the oppor- ERAL REGISTER. tunity for a hearing; or (2) Not to avail himself of the oppor- § 515.25 Revocation of order refusing tunity for a hearing. to approve a medicated feed mill li- (b) If the applicant fails to file a cense application or suspending or written appearance in answer to the revoking a license. notice of opportunity for hearing, this The Commissioner of Food and Drugs failure will be construed as an election (the Commissioner), upon his/her own not to avail himself of the opportunity initiative or upon request of an appli- for the hearing, and the Commissioner cant stating reasonable grounds there- without further notice may enter a for and if the Commissioner finds that final order. the facts so require, may issue an order (c) If the applicant elects to avail approving a medicated feed mill license himself of the opportunity for a hear- application that previously has had its ing, the applicant is required to file a approval refused, suspended, or re- written appearance requesting the voked. hearing within 30 days after the publication of the notice, giving the reason § 515.26 Services of notices and orders. why the application should not be re- All notices and orders under this part fused or the medicated feed mill license 515 and section 512 of the Federal Food, should not be revoked, together with a Drug, and Cosmetic Act (the act) per- well-organized and full-factual analysis

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of the information the applicant is pre- § 314.200(g) of this chapter, the re- pared to prove in support of his opposi- quest(s) for hearing together with the tion to the Commissioner’s proposal. A data and information submitted and request for a hearing may not rest the Commissioner’s findings and con- upon mere allegations or denials, but clusions shall be included in the record must set forth specific facts showing certified by the Commissioner. there is a genuine and substantial issue of fact that requires a hearing. When it PART 516—NEW ANIMAL DRUGS clearly appears from the information FOR MINOR USE AND MINOR in the application and from the reasons and factual analysis in the request for SPECIES the hearing that no genuine and substantial issue of fact precludes the re- Subpart A—General Provisions fusal to approve the application or the Sec. revocation of approval of the applica- 516.1 Scope. tion, the Commissioner will enter an 516.2 Purpose. order on this information, stating his/ 516.3 Definitions. her findings and conclusions. If a hearing is requested and is justified by the Subpart B—Designation of a Minor Use or applicant’s response to the notice of Minor Species New Animal Drug opportunity for a hearing, the issues 516.11 Scope of this subpart. will be defined, an Administrative Law 516.12 Purpose. Judge will be named, and the Judge 516.13 Definitions. shall issue a written notice of the time 516.14 Submission of requests for designa- and place at which the hearing will tion. commence. In the case of denial of ap- 516.16 Eligibility to request designation. 516.20 Content and format of a request for proval, such time shall be not more MUMS-drug designation. than 90 days after the expiration of 516.21 Documentation of minor use status. such 30 days unless the Administrative 516.22 Permanent-resident U.S. agent for Law Judge and the applicant otherwise foreign sponsor. agree; and, in the case of withdrawal of 516.23 Timing of requests for MUMS-drug approval, such time shall be as soon as designation. practicable. 516.24 Granting MUMS-drug designation. (d) The hearing will be open to the 516.25 Refusal to grant MUMS-drug designation. public; however, if the Commissioner 516.26 Amendment to MUMS-drug designa- finds that portions of the application tion. which serve as a basis for the hearing 516.27 Change in sponsorship. contain information concerning a 516.28 Publication of MUMS-drug designa- method or process entitled to protec- tions. tion as a trade secret, the part of the 516.29 Termination of MUMS-drug designa- hearing involving such portions will tion. not be public, unless the respondent so 516.30 Annual reports for a MUMS-designated drug. specifies in the appearance. 516.31 Scope of MUMS-drug exclusive marketing rights. § 515.31 Procedures for hearings. 516.34 FDA recognition of exclusive mar- Hearings relating to new animal keting rights. drugs under section 512(m)(3) and (m)(4) 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 data and information in requests. by part 12 of this chapter. Subpart C—Index of Legally Marketed Un- Subpart D—Judicial Review approved New Animal Drugs for Minor Species § 515.40 Judicial review. The transcript and record shall be 516.111 Scope of this subpart. 516.115 Definitions. certified by the Commissioner of Food 516.117 Submission of correspondence under and Drugs (the Commissioner). In any this subpart. case in which the Commissioner enters 516.119 Permanent-resident U.S. agent for an order without a hearing under foreign requestors and holders.

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516.121 Meetings. Regulations are to Chapter I of Title 516.123 Informal conferences regarding 21, unless otherwise noted. agency administrative actions. 516.125 Investigational use of minor species § 516.2 Purpose. new animal drugs to support indexing. 516.129 Content and format of a request for This part establishes standards and determination of eligibility for indexing. procedures for implementing section 516.131 Refuse to file a request for deter- 573 of the act, including designation of mination of eligibility for indexing. 516.133 Denying a request for determination minor use or minor species new animal of eligibility for indexing. drugs and associated exclusive mar- 516.135 Granting a request for determina- keting rights. tion of eligibility for indexing. 516.137 Notification of decision regarding § 516.3 Definitions. eligibility for indexing. 516.141 Qualified expert panels. (a) The definitions and interpreta- 516.143 Written report. tions contained in section 201 of the 516.145 Content and format of a request for Federal Food, Drug, and Cosmetic Act addition to the index. (the act) (21 U.S.C. 321) apply to those 516.147 Refuse to file a request for addition terms when used in this part. to the index. 516.149 Denying a request for addition to the (b) The following definitions of terms index. apply to all subparts of part 516: 516.151 Granting a request for addition to Active moiety means the molecule or the index. ion, excluding those appended portions 516.153 Notification of decision regarding of the molecule that cause the drug to index listing. 516.155 Labeling of indexed drugs. be an ester, salt (including a salt with 516.157 Publication of the index and content hydrogen or coordination bonds), or of an index listing. other noncovalent derivative (such as a 516.161 Modifications to indexed drugs. complex, chelate, or clathrate) of the 516.163 Change in ownership of an index file. molecule, responsible for the pharma- 516.165 Records and reports. cological action of the drug substance. 516.167 Removal from the index. 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 conditionally-approved or approved MUMS Subpart E—Conditionally Approved New drug, that is otherwise the same drug, Animal Drugs For Minor Use and Minor in one or more of the following ways: Species (i) The drug has been shown to be 516.1318 xMasitinib. more effective, as assessed by effect on 516.1684 Paclitaxel. a clinically meaningful endpoint in AUTHORITY: 21 U.S.C. 360ccc–1, 360ccc–2, 371. adequate and well-controlled clinical trials, than a conditionally approved or SOURCE: 72 FR 41017, July 26, 2007, unless 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.

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Infrequently, as used in the minor use same, it is considered the same drug; definition, means a disease or condi- except that, if the prior MUMS drug is tion that is uncommon or that occurs conditionally approved or approved and only sporadically on an annualized the second MUMS drug is shown to be basis. functionally superior to the condi- Limited geographical areas, as used in tionally approved or approved MUMS the minor use definition, means re- drug for the same intended use, it is gions of the United States distin- not considered the same drug. guished by physical, chemical, or bio- (ii) If it is a MUMS drug composed of logical factors that limit the distribu- large molecules (macromolecules) and tion of a disease or condition. contains the same principal molecular Major species means cattle, horses, structural features (but not necessarily swine, chickens, turkeys, dogs, and all of the same structural features) as cats. a prior designated, conditionally ap- Minor species means animals, other proved, or approved MUMS drug, it is than humans, that are not major spe- considered the same drug; except that, cies. if the prior MUMS drug is condi- Minor use means the intended use of tionally approved or approved and the a drug in a major species for an indica- second MUMS drug is shown to be function that occurs infrequently and in tionally superior to the conditionally only a small number of animals or in approved or approved MUMS drug for limited geographical areas and in only the same intended use, it is not consid- a small number of animals annually. ered the same drug. This criterion will MUMS drug means a new animal be applied as follows to different kinds drug, as defined in section 201 of the of macromolecules: act, intended for a minor use or for use (A) Two protein drugs would be con- in a minor species. sidered the same if the only differences 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

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same unless the subsequent drug is tion (in this context, the sponsor may shown to be functionally superior. be an individual, partnership, organiza- Same intended use means an intended tion, or association). In all contexts, use of a MUMS drug, for which designa- the sponsor is responsible for compli- tion, indexing, or conditional approval ance with applicable provisions of the is sought, that is determined to be the act and regulations. same as (or not different from) a previously designated, conditionally ap- [72 FR 41017, July 26, 2007, as amended at 74 FR 43050, Aug. 25, 2009; 75 FR 69588, Nov. 15, proved, or approved intended use of a 2010] MUMS drug. Same intended use is established by comparing two intended uses and not by simply comparing the Subpart B—Designation of a Minor specific language by means of which Use or Minor Species New the intent is established in labeling in Animal Drug accordance with the following criteria: (i) Two intended uses are considered § 516.11 Scope of this subpart. the same if one of the intended uses This subpart implements section 573 falls completely within the scope of the of the act. Specifically, this subpart other. sets forth the procedures and require- (ii) For intended uses associated with ments for submissions to FDA of re- diseases or conditions with multiple quests for designation of a new animal causative organisms, two intended uses drug for a minor use or a minor spe- are not considered the same when they cies. involve different causative organisms or different subsets of causative orga- § 516.12 Purpose. nisms of that disease or condition when This subpart establishes standards the causative organisms involved can and procedures for determining eligi- 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. Small number of animals means equal The following definitions of terms to or less than 50,000 horses; 70,000 dogs; apply only in the context of subpart B 120,000 cats; 310,000 cattle; 1,450,000 pigs; of this part: 14,000,000 turkeys; and 72,000,000 chick- Director means the Director of the Of- ens. fice of Minor Use and Minor Species Sponsor means the person requesting Animal Drug Development of the FDA designation for a MUMS drug who Center for Veterinary Medicine. must be the real party in interest of Intended use means the intended the development and the intended or treatment, control or prevention of a actual production and sales of such disease or condition, or the intention drug (in this context, the sponsor may to affect the structure or function of be an individual, partnership, organiza- the body of animals within an identi- tion, or association). Sponsor also fied species, subpopulation of a species, means the person responsible for an in- or collection of species. vestigation of a new animal drug (in MUMS-designated drug means a new this context, the sponsor may be an in- animal drug, as defined in section 201 dividual, partnership, corporation, or of the act, intended for a minor use or Government agency or may be a manu- for use in a minor species that has been facturer, scientific institution, or an designated under section 573 of the act. 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

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for a MUMS-designated drug, no condi- dent U.S. agent including title, ad- tional approval or approval will be dress, and telephone number; the estab- given to a subsequent application for lished name (and proprietary name, if the same drug, in the same dosage any) of the active pharmaceutical inform, for the same intended use for 7 gredient of the drug; and the name and years, except as otherwise provided by address of the source of the active law or in this subpart. pharmaceutical ingredient of the drug. (3) A description of the proposed in- § 516.14 Submission of requests for tended use for which the drug is being designation. or will be investigated. All correspondence relating to a re- (4) A description of the drug and dos- quest for designation of a MUMS drug age form. must be addressed to the Director of (5) A discussion of the scientific ra- the Office of Minor Use and Minor Spe- tionale for the intended use of the cies Animal Drug Development. Sub- drug; specific reference, including missions not including all elements date(s) of submission, to all data from specified in § 516.20 will be returned to nonclinical laboratory studies, clinical the sponsor without review. investigations, copies of pertinent unpublished and published papers, and § 516.16 Eligibility to request designa- other relevant data that are available tion. to the sponsor, whether positive, nega- The person requesting designation tive, or inconclusive. must be the sponsor and the real party (6) A specific description of the prod- in interest of the development and the uct development plan for the drug, its intended or actual production and sales dosage form, and its intended use. of the drug or the permanent-resident (7) If the drug is intended for a minor U.S. agent for such a sponsor. use in a major species, documentation in accordance with § 516.21, with ap- § 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 [72 FR 41017, July 26, 2007, as amended at 75 for an already conditionally approved FR 69588, Nov. 15, 2010; 77 FR 18685, Mar. 28, or approved drug. Only one sponsor 2012] may receive MUMS-drug designation of the same drug, in the same dosage § 516.21 Documentation of minor use form, for the same intended use. status. (b) A sponsor must submit two copies So that FDA can determine whether of a completed, dated, and signed re- a drug qualifies for MUMS-drug des- quest for designation that contains the ignation as a minor use in a major spe- following information: cies under section 573 of the act, the (1) A request for designation of a new sponsor shall include in its request to animal drug for a minor use or use in FDA for MUMS-drug designation under a minor species, which must be spe- § 516.20 documentation demonstrating cific. that the use is limited to a small num- (2) The name and address of the spon- ber of animals (annualized). This docu- sor; the name of the sponsor’s primary mentation must include the following contact person and/or permanent-resi- information:

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(a) The estimated total number of § 516.23 Timing of requests for MUMS- animals to which the drug could poten- drug designation. tially be administered on an annual A sponsor may request MUMS-drug basis for the treatment, control, or pre- designation at any time in the drug de- vention of the disease or condition for velopment process prior to the submis- which the drug is being developed, in- sion of an application for either condi- cluding animals administered the drug tional approval or approval of the as part of herd or flock treatment, to- MUMS drug for which designation is gether with a list of the sources (in- being requested. cluding dates of information provided and literature citations) for the esti- § 516.24 Granting MUMS-drug designa- mate. tion. (b) The estimated total number of (a) FDA may grant the request for animals referred to in paragraph (a) of MUMS-drug designation if none of the this section may be further reduced to reasons described in § 516.25 for refusal only a subset of the estimated total to grant such a request apply. number of animals if administration of (b) When a request for MUMS-drug the drug is only medically justified for designation is granted, FDA will notify the sponsor in writing and will give this subset. To establish this, reques- public notice of the MUMS-drug des- tors must demonstrate that adminis- ignation in accordance with § 516.28. tration of the drug to animals subject to the disease or condition for which § 516.25 Refusal to grant MUMS-drug the drug is being developed other than designation. the subset is not medically justified. (a) FDA will refuse to grant a request The sponsor must also include a list of for MUMS-drug designation if any of the sources (including dates of infor- the following reasons apply: mation provided and literature cita- (1) The drug is not intended for use in tions) for the justification that admin- a minor species or FDA determines istration of the drug to animals other that there is insufficient evidence to than the targeted subset is medically demonstrate that the drug is intended inappropriate. for a minor use in a major species. [72 FR 41017, July 26, 2007, as amended at 74 (2) The drug is the same drug in the FR 43050, Aug. 25, 2009] same dosage form for the same intended use as one that already has a § 516.22 Permanent-resident U.S. agent MUMS-drug designation but has not for foreign sponsor. yet been conditionally approved or approved. Every foreign sponsor that seeks (3) The drug is the same drug in the MUMS-drug designation shall name a same dosage form for the same in- permanent resident of the United tended use as one that is already condi- States as the sponsor’s agent upon tionally approved or approved. A drug whom service of all processes, notices, that FDA has found to be functionally orders, decisions, requirements, and superior is not considered the same other communications may be made on drug as an already conditionally ap- behalf of the sponsor. Notifications of proved or approved drug even if it is changes in such agents or changes of otherwise the same drug in the same address of agents should preferably be dosage form for the same intended use. provided in advance, but not later than (4) The sponsor has failed to provide: 60 days after the effective date of such (i) A credible scientific rationale in changes. The permanent-resident U.S. support of the intended use, agent may be an individual, firm, or (ii) Sufficient information about the domestic corporation and may rep- product development plan for the drug, resent any number of sponsors. The its dosage form, and its intended use to name and address of the permanent- establish that adherence to the plan resident U.S. agent shall be provided to can lead to successful drug develop- the Director of the Office of Minor Use ment in a timely manner, and and Minor Species Animal Drug Devel- (iii) Any other information required opment. under § 516.20.

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(b) FDA may refuse to grant a re- the MUMS-drug designation, has been quest for MUMS-drug designation if provided to the new sponsor. the request for designation contains an (2) The new sponsor shall submit a untrue statement of material fact or letter or other document containing omits material information. the following information: (i) A statement accepting the MUMS- § 516.26 Amendment to MUMS-drug drug designated file or application; designation. (ii) The date that the change in spon- (a) At any time prior to conditional sorship is intended to be effective; approval or approval of an application (iii) A statement that the new spon- for a MUMS-designated drug, the sponsor has a complete copy of the request sor may apply for an amendment to the for MUMS-drug designation, including designated intended use if the proposed any amendments to the request and change is due to new and unexpected any correspondence relevant to the findings in research on the drug, infor- MUMS-drug designation; mation arising from FDA recommenda- (iv) A statement that the new spon- tions, or other unforeseen develop- sor understands and accepts the re- ments. sponsibilities of a sponsor of a MUMS- (b) FDA will grant the amendment if designated drug established elsewhere it finds: in this subpart; (1) That the initial designation re- (v) The name and address of a new quest was made in good faith; primary contact person or permanent (2) That the amendment is intended resident U.S. agent; and to make the MUMS-drug designated in- (vi) Evidence that the new sponsor is tended use conform to the results of capable of actively pursuing approval new and unexpected findings in re- with due diligence. search on the drug, information arising (b) No sponsor may relieve itself of from FDA recommendations, or other responsibilities under the act or under unforeseen developments; and this subpart by assigning rights to an- (3) In the case of a minor use, that as other person without: of the date of the submission of the (1) Assuring that the new sponsor amendment request, the amendment will carry out such responsibilities; would not result in the intended use of and the drug no longer being considered a (2) Obtaining prior permission from minor use. FDA.

§ 516.27 Change in sponsorship. § 516.28 Publication of MUMS-drug (a) A sponsor may transfer sponsor- designations. ship of a MUMS-designated drug to an- FDA will periodically update a pub- other person. A change of sponsorship licly available list of MUMS-designated will also transfer the designation sta- drugs. This list will be placed on file at tus of the drug which will remain in ef- the FDA Division of Dockets Manage- fect for the new sponsor subject to the ment, and will contain the following same conditions applicable to the information for each MUMS-designated former sponsor provided that at the drug: time of a potential transfer, the new (a) The name and address of the spon- and former sponsors submit the fol- sor; lowing information in writing and ob- (b) The established name and trade tain permission from FDA: name, if any, of the drug; (1) The former sponsor shall submit a (c) The dosage form of the drug; letter to FDA that documents the (d) The species and the proposed in- transfer of sponsorship of the MUMS- tended use for which MUMS-drug des- designated drug. This letter shall speci- ignation was granted; and fy the date of the transfer. The former (e) The date designation was granted. sponsor shall also certify in writing to FDA that a complete copy of the re- § 516.29 Termination of MUMS-drug quest for MUMS-drug designation, in- designation. cluding any amendments to the re- (a) The sponsor of a MUMS-des- quest, and correspondence relevant to ignated drug must notify FDA of any

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decision to discontinue active pursuit sponsor’s exclusive marketing rights of conditional approval or approval of for the drug but does not withdraw the such MUMS drug. FDA must terminate conditional approval or approval of the the designation upon such notification. drug’s application. (b) A conditionally-approved or ap- (h) Where a drug has been MUMS-des- proved MUMS-designated drug sponsor ignated for a minor use in a major spe- must notify FDA at least 1 year before cies, its designation will not be termi- it intends to discontinue the manufac- nated on the grounds that the number ture of such MUMS drug. FDA must of animals to which the drug could po- terminate designation upon such noti- tentially be administered on an annual fication. basis for the treatment, control, or pre- (c) MUMS designation shall termi- vention of the disease or condition for nate upon the expiration of any appli- which the drug is being developed, in- cable period of exclusive marketing cluding animals administered the drug rights under this subpart. as part of herd or flock treatment, sub- (d) FDA may terminate designation sequently increases. if it independently determines that the (i) When a MUMS-drug designation is sponsor is not actively pursuing condi- terminated, FDA will notify the spon- tional approval or approval with due sor in writing and will give public no- 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-

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drug designation has been granted, the notice of conditional approval or FDA will not conditionally approve or approval of the application. approve another application or abbreviated application for the same drug in § 516.36 Insufficient quantities of the same dosage form for the same in- MUMS-designated drugs. tended use before the expiration of 7 (a) Under section 573 of the act, years after the date of conditional ap- whenever FDA has reason to believe proval or approval as stated in the ap- that sufficient quantities of a condi- proval letter from FDA, except that tionally-approved or approved, MUMS- such an application can be condi- designated drug to meet the needs for tionally approved or approved sooner which the drug was designated cannot if, and at such time as, any of the fol- be assured by the sponsor, FDA will so lowing occurs: (1) FDA terminates the MUMS-drug notify the sponsor of this possible in- designation and associated exclusive sufficiency and will offer the sponsor marketing rights under § 516.29; or the following options, one of which (2) FDA withdraws the conditional must be exercised by a time that FDA approval or approval of the application specifies: for the drug for any reason; or (1) Provide FDA information and (3) The sponsor with exclusive mar- data regarding how the sponsor can as- keting rights provides written consent sure the availability of sufficient quan- to FDA to conditionally approve or ap- tities of the MUMS-designated drug prove another application before the within a reasonable time to meet the expiration of 7 years; or needs for which the drug was des- (4) The sponsor fails to assure a suffi- ignated; or cient quantity of the drug in accord- (2) Provide FDA in writing the spon- ance with section 573 of the act and sor’s consent for the conditional ap- § 516.36. proval or approval of other applica- (b) If an application for a MUMS drug tions for the same drug before the expi- cannot be approved until the expira- ration of the 7-year period of exclusive tion of the period of exclusive mar- marketing rights. keting of a MUMS-designated drug, (b) If, within the time that FDA FDA will so notify the sponsor in writ- specifies, the sponsor fails to consent ing. to the conditional approval or approval § 516.34 FDA recognition of exclusive of other applications and if FDA finds marketing rights. that the sponsor has not shown that it (a) FDA will send the sponsor (or the can assure the availability of sufficient permanent-resident U.S. agent, if ap- quantities of the MUMS-designated plicable) timely written notice recog- drug to meet the needs for which the nizing exclusive marketing rights when drug was designated, FDA will issue a an application for a MUMS-designated written order terminating designation drug has been conditionally approved of the MUMS drug and the associated or approved. The written notice will in- exclusive marketing rights. This order form the sponsor of the requirements will state FDA’s findings and conclu- for maintaining MUMS-designated sions and will constitute final agency drug exclusive marketing rights for the action. An order terminating designa- full 7-year term. This notice will gen- tion and associated exclusive mar- erally be contained in the letter condi- keting rights may issue whether or not tionally approving or approving the ap- there are other sponsors that can as- plication. sure the availability of alternative (b) When an application is condi- sources of supply. Such an order will tionally approved or approved for a not withdraw the conditional approval MUMS-designated drug that qualifies or approval of an application. Once ter- for exclusive marketing rights, FDA minated under this section, neither will publish this information in the designation, nor exclusive marketing FEDERAL REGISTER at the time of the conditional approval or approval. This rights may be reinstated. notice will generally be contained in

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§ 516.52 Availability for public disclo- ducing minor species, where safety for sure of data and information in re- humans is demonstrated in accordance quests. with the standard of section 512(d) of (a) FDA will not publicly disclose the the act (including, for an antimicrobial existence of a request for MUMS-drug new animal drug, with respect to anti- designation under section 573 of the act microbial resistance). The index shall prior to final FDA action on the re- not include a new animal drug that is quest unless the existence of the re- contained in, or a product of, a quest has been previously publicly dis- transgenic animal. Among its topics, closed or acknowledged. this subpart sets forth the standards (b) Whether or not the existence of a and procedures for: pending request for designation has (a) Investigational exemptions for in- been publicly disclosed or acknowl- dexing purposes; edged, no data or information in the re- (b) Submissions to FDA of requests quest are available for public disclo- for determination of eligibility of a sure prior to final FDA action on the new animal drug for indexing; request. (c) Establishment and operation of (c) Except as provided in paragraph expert panels; (d) of this section, upon final FDA ac- (d) Submissions to FDA of requests tion on a request for designation, the for addition of a new animal drug to public availability of data and informa- the index; tion in the request will be determined (e) Modifications to index listings; in accordance with part 20 of this chap- (f) Publication of the index; and ter and other applicable statutes and (g) Records and reports. regulations. § 516.115 Definitions. (d) In accordance with § 516.28, FDA will make a cumulative list of all (a) The following definitions of terms MUMS-drug designations available to apply only in the context of subpart C the public and update such list periodi- of this part: cally. In accordance with § 516.29, FDA Director OMUMS means the Director will give public notice of the termi- of the Office of Minor Use and Minor nation of all MUMS-drug designations. Species Animal Drug Development of 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. SOURCE: 72 FR 69121, Dec. 6, 2007, unless Index means FDA’s list of legally 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

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animal of which the nucleotide se- discuss the requirements for indexing a quence of the genome has been modi- new animal drug. fied solely by selective breeding. (b) Requests for such meetings should (b) The definitions of the following be in writing, be addressed to the Di- terms are given in § 514.3 of this chap- rector, OMUMS, specify the partici- ter: pants attending on behalf of the re- Adverse drug experience. questor or potential requestor, and Product defect/manufacturing defect. contain a proposed agenda for the Serious adverse drug experience. meeting. Unexpected adverse drug experience. (c) Within 30 days of receiving a re- (c) The definitions of the following quest for a meeting, FDA will attempt terms are given in § 516.3 of this chap- to schedule the meeting at a time ter: agreeable to both FDA and the person Same dosage form. making the request. Same drug. Same intended use. § 516.123 Informal conferences regarding agency administrative actions. § 516.117 Submission of correspond- (a) Should FDA make an initial deci- ence under this subpart. sion denying a request for determina- Unless directed otherwise by FDA, tion of eligibility for indexing, termi- all correspondence relating to any as- nating an investigational exemption, pect of the new animal drug indexing determining that a qualified expert process described in this subpart must panel does not meet the selection cri- 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.

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At the option of the person requesting submission of information at the close an informal conference, such written of the conference, unless the presiding response to FDA’s initial decision may officer specifically permits additional act in lieu of a face-to-face meeting. In time for further submission. this case, the informal conference will (n) The administrative record of the consist of a review by the presiding of- informal conference specified herein ficer of the submitted written response. constitutes the exclusive record for de- (f) The purpose of an informal con- cision. ference is to discuss scientific and factual issues. It will involve a discussion § 516.125 Investigational use of minor of FDA’s initial decision and any writ- species new animal drugs to sup- ten response to that decision. port indexing. (g) Internal agency review of a deci- (a) The investigational use of a new sion must be based on the information animal drug or animal feed bearing or in the administrative file. If the person containing a new animal drug intended requesting an informal conference pre- solely for investigational use in minor sents new information not in the file, species shall meet the requirements of the matter will be returned to the ap- part 511 of this chapter if the investiga- propriate lower level in the agency for tional use is for the purpose of: reevaluation based on the new informa- (1) Demonstrating human food safety tion. under section 572(a)(1)(B) of the act; (h) Informal conferences under this (2) Demonstrating safety with re- part are not subject to the separation spect to individuals exposed to the new 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 objections relating to the admissibility (3) Conducting an environmental as- of information and views will be made sessment under section 572(c)(1)(E) of or considered, but any party to the the act; or conference may comment upon or (4) Obtaining approval of a new ani- rebut all such data, information and mal drug application or abbreviated views. new animal drug application under sec- (j) [Reserved] tion 512(b) of the act. (k) The presiding officer will prepare (b) Correspondence and information a written report regarding the subject associated with investigations de- of the informal conference that states scribed in paragraph (a) of this section and describes the basis for his or her shall not be sent to the Director, findings. Whenever time permits, the OMUMS, but shall be submitted to parties to the informal conference will FDA in accordance with the provisions have 30 days to review and comment on of part 511 of this chapter. the report. (c) The investigational use of a new (l) The administrative record of the animal drug or animal feed bearing or informal conference will consist of: containing a new animal drug intended (1) The notice providing an oppor- solely for investigational use in minor tunity for an informal conference and species, other than for an investiga- the written response to the notice. tional use described in paragraph (a) of (2) All written information and views this section, shall meet the require- submitted to the presiding officer at ments of this section. For such inves- the conference or, at the discretion of tigations, all provisions of part 511 of the presiding officer, thereafter. this chapter apply with the following (3) The presiding officer’s written re- modifications: port. (1) Under § 511.1(a)(1) of this chapter, (4) All correspondence and memo- the label statement is as follows: 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 (m) The administrative record of the in support of index listing. Not for use informal conference is closed to the in humans.’’

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(2) Under § 511.1(b)(1) of this chapter, § 516.129 Content and format of a re- the label statement is as follows: quest for determination of eligi- ‘‘Caution. Contains a new animal bility for indexing. drug for use only in investigational (a) Each request for determination of animals in clinical trials in support of eligibility: index listing. Not for use in humans. (1) May involve only one drug (or one Edible products of investigational ani- combination of drugs) in one dosage mals are not to be used for food for hu- form; mans or other animals unless author- (2) May not involve a new animal ization has been granted by the U.S. drug that is contained in or a product Food and Drug Administration or by of a transgenic animal; the U.S. Department of Agriculture.’’ (3) May not involve the same drug in (3) Under § 511.1(b)(4) of this chapter, the same dosage form for the same in- the notice is titled ‘‘Notice of Claimed tended use as a drug that is already ap- Investigational Exemption for a New proved or conditionally approved; and Animal Drug for Index Listing’’ and is (4) Must be submitted separately. submitted in duplicate to the Director, (b) A request for determination of eli- OMUMS. gibility for indexing may involve mul- (4) Under § 511.1(c)(3) of this chapter, tiple intended uses and/or multiple if an investigator is determined to be minor species. However, if a request for ineligible to receive new animal drugs, determination of eligibility for index- each ‘‘Notice of Claimed Investiga- ing that contains multiple intended tional Exemption for a New Animal uses and/or multiple minor species can- Drug for Index Listing’’ and each re- not be granted in any part, the entire quest for indexing shall be examined request will be denied. with respect to the reliability of infor- (c) A requestor must submit two cop- mation submitted by the investigator. ies of a dated request signed by the au- (5) Under § 511.1(c)(4) and (d)(2) of this thorized contact person for determina- chapter, with respect to termination of tion of eligibility for indexing that exemptions, the sponsor of an inves- contains the following: tigation shall not be granted an oppor- (1) Identification of the minor species tunity for a regulatory hearing before or groups of minor species for which FDA pursuant to part 16 of this chap- the new animal drug is intended; ter. Instead, the sponsor shall have an (2) Information regarding drug com- opportunity for an informal conference ponents and composition; as described in § 516.123. (3) A statement of the intended use(s) (6) Under § 511.1(c)(5) of this chapter, of the new animal drug in the identi- if the Commissioner of Food and Drugs fied minor species or groups of minor determines, after the unreliable data species; submitted by the investigator are (4) A statement of the proposed con- eliminated from consideration, that ditions of use associated with the stat- the data remaining are such that a reed intended use(s) of the new animal quest for addition to the index would drug, including the proposed dosage, have been denied, FDA will remove the route of administration, contraindica- new animal drug from the index in actions, warnings, and any other signifi- cordance with § 516.167. cant limitations associated with the (d) The investigational use of a new intended use(s) of the new animal drug; animal drug or animal feed bearing or (5) A brief discussion of the need for containing a new animal drug subject the new animal drug for the intended to paragraph (c) of this section shall use(s); not be subject to the good laboratory (6) An estimate of the anticipated an- practice requirements in part 58 of this nual distribution of the new animal chapter. drug, in terms of the total quantity of (e) Correspondence and information active ingredient, after indexing; associated with investigations de- (7) Information to establish that the scribed in paragraph (c) of this section new animal drug is intended for use: shall be sent to the Director, OMUMS, (i) In a minor species for which there in accordance with the provisions of is a reasonable certainty that the ani- this section. mal or edible products from the animal

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will not be consumed by humans or determines upon the basis of the re- food-producing animals; or quest evaluated together with any (ii) In a hatchery, tank, pond, or other information before it with re- other similar contained man-made spect to the new animal drug that: structure in (which includes on) an (1) The same drug in the same dosage early, non-food life stage of a food-pro- form for the same intended use is al- ducing minor species, and information ready approved or conditionally ap- to demonstrate food safety in accord- proved; ance with the standards of section (2) There is insufficient information 512(d) of the act and § 514.111 of this to demonstrate that the new animal chapter (including, for an anti- drug is intended for use: microbial new animal drug, with re- (i) In a minor species for which there spect to antimicrobial resistance); is a reasonable certainty that the ani- (8) A description of the methods used mal or edible products from the animal in, and the facilities and controls used will not be consumed by humans or for, the manufacture, processing and food-producing animals, or packing of the new animal drug suffi- (ii) In a hatchery, tank, pond, or cient to demonstrate that the re- other similar contained man-made questor has established appropriate structure in (which includes on) an specifications for the manufacture and early, non-food life stage of a food-pro- control of the new animal drug and ducing minor species, and there is in- 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 to demonstrate that the requestor has manufacture and use; and established appropriate specifications (11) The name and address of the con- for the manufacture and control of the tact person or permanent-resident U.S. new animal drug and that the re- agent. questor has an understanding of current good manufacturing practices; § 516.131 Refuse to file a request for (5) The requester fails to submit an determination of eligibility for inadequate environmental assessment dexing. under § 25.40 of this chapter or fails to (a) If a request for determination of provide sufficient information to estab- eligibility for indexing contains all of lish that the requested action is sub- the information required by § 516.129, ject to categorical exclusion under FDA shall file it, and the filing date § 25.30 or § 25.33 of this chapter; shall be the date FDA receives the re- (6) There is insufficient information quest. to determine that the new animal drug (b) If a request for a determination of is safe with respect to individuals ex- eligibility lacks any of the information posed to the new animal drug through required by § 516.129, FDA will not file its manufacture or use; or it, but will inform the requestor in (7) The request for determination of writing within 30 days of receiving the eligibility for indexing fails to contain request as to what information is lack- any other information required under ing. the provisions of § 516.129. (b) FDA may deny a request for de- § 516.133 Denying a request for deter- termination of eligibility for indexing mination of eligibility for indexing. if it contains any untrue statement of (a) FDA will deny a request for deter- a material fact or omits material infor- mination of eligibility for indexing if it mation.

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(c) When a request for determination (b) Criteria for the selection of a quali- of eligibility for indexing is denied, fied expert panel. (1) A qualified expert FDA will notify the requestor in ac- panel member must be an expert quali- cordance with § 516.137. fied by training and experience to evaluate a significant aspect of target § 516.135 Granting a request for deter- animal safety or effectiveness of the mination of eligibility for indexing. new animal drug under consideration. (a) FDA will grant the request for de- (2) A qualified expert panel member termination of eligibility for indexing must certify that he or she has a work- if none of the reasons described in ing knowledge of section 572 of the act § 516.133 for denying such a request ap- (the indexing provisions of the statute) plies. and this subpart, and that he or she has (b) When a request for determination also read and understood a clear writ- of eligibility for indexing is granted, ten statement provided by the re- FDA will notify the requestor in ac- questor stating his or her duties and cordance with § 516.137. responsibilities with respect to review- ing the new animal drug proposed for § 516.137 Notification of decision regarding eligibility for indexing. addition to the index. (3) A qualified expert panel member (a) Within 90 days after the filing of may not be an FDA employee. a request for a determination of eligi- (4) A qualified expert panel must bility for indexing based on have at least three members. § 516.129(c)(7)(i), or 180 days for a request 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 (b) If FDA denies the request, FDA evaluate the target animal safety and shall provide due notice and an oppor- effectiveness of the new animal drug tunity for an informal conference as under consideration. described in § 516.123 regarding its deci- (6) Unless FDA makes a determina- sion. A decision of FDA to deny a re- tion to allow participation notwith- quest for determination of eligibility standing an otherwise disqualifying fi- for indexing following an informal con- nancial interest, a qualified expert ference shall constitute final agency panel member must not have a conflict action subject to judicial review. of interest or the appearance of a conflict of interest, as described in para- § 516.141 Qualified expert panels. graph (g) of this section. (a) Establishment of a qualified expert (c) Requestor responsibilities. (1) The panel. Establishing a qualified expert requestor must: panel is the first step in the process of (i) Choose members for the qualified requesting the addition of a new ani- expert panel in accordance with selec- mal drug to the index. A qualified ex- tion criteria listed in paragraph (b) of pert panel may not be established until this section. FDA has determined that the new ani- (ii) Provide each potential expert mal drug is eligible for indexing. The panel member a copy of section 572 of requestor must choose members for the the act (the indexing provisions of the qualified expert panel in accordance statute) and this subpart and obtain with selection criteria listed in para- certification that he or she has a work- graph (b) of this section and submit in- ing knowledge of the information. formation about these proposed mem- (iii) Provide each potential expert bers to FDA. FDA must determine panel member a written statement de- whether the proposed qualified expert scribing the purpose and scope of his or panel meets the selection criteria prior her participation on the qualified ex- to the panel beginning its work. Quali- pert panel and obtain certification that fied expert panels operate external to he or she has read and understood the FDA and are not subject to the Federal information. The written statement Advisory Committee Act, as amended, should describe the duties and respon- 5 U.S.C. App. sibilities of qualified expert panels and

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their members established by para- from, qualified expert panel members, graphs (e) and (f) of this section, in- including the written report, for 2 cluding the need to prepare a written years after the completion of the re- report under § 516.143. port, or the product is added to the (iv) Obtain information from each po- index, whichever occurs later, and tential expert panel member dem- make them available to a duly author- onstrating that he or she is qualified ized employee of the agency at all rea- by training and experience to evaluate sonable times. the target animal safety and effective- (d) FDA responsibilities. (1) FDA will ness of the new animal drug under con- determine whether the requestor’s pro- sideration. This information can be ob- posed qualified expert panel meets the tained from a comprehensive cur- selection criteria listed in paragraph riculum vitae or similar document. (b) of this section. FDA will expedi- (v) Notify each potential expert panel tiously inform the requestor, in writ- member that he or she must submit in- ing, of its determination. If FDA deter- formation relating to potential conflict mines that the qualified expert panel of interest directly to FDA in a timely does not meet the selection criteria, 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 leader. tion by FDA, following an informal (4) The requestor must immediately conference, that a qualified expert notify FDA if it believes a qualified ex- panel no longer meets the selection cri- pert panel member no longer meets the teria listed in paragraph (b) of this sec- selection criteria listed in paragraph tion or that the panel or its members (b) of this section or is otherwise not in are not in compliance with the require- compliance with the requirements of ments of this section shall constitute this section. final agency action subject to judicial (5) If a qualified expert panel member review. cannot complete the review for which (e) Responsibilities of a qualified expert he or she was selected, the requestor panel member. A qualified expert panel must either choose a replacement or member must do the following: 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.

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The panel should also consider all rel- that could impair a person’s objec- evant information otherwise known by tivity in serving on the qualified expert the panel members, including anec- panel or could create an unfair com- dotal information. petitive advantage for a person or orga- (4) Participate in the preparation of nization. the written report of the findings of (2) Factors relevant to whether there the qualified expert panel, described in is a conflict of interest or the appear- § 516.143. ance of a conflict of interest include (5) Sign, or otherwise approve in whether the qualified expert panel writing, the written report. Such sig- member, their spouse, their minor chil- nature or other written approval will dren, their general partners, or any or- serve as certification that the written ganizations in which they serve as an report meets the requirements of the officer, director, trustee, general part- written report in § 516.143. ner or employee: (6) Provide the information relating (i) Is currently receiving or seeking to potential conflict of interest de- funding from the requestor through a scribed in paragraph (g) of this section contract or research grant (either di- 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

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

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(e) Be signed, or otherwise approved (7) A written commitment to manu- in writing, by all panel members, in ac- facture the new animal drug and ani- cordance with § 516.141; and mal feeds bearing or containing such (f) If the panel unanimously con- new animal drug according to current cludes that the benefits of using the good manufacturing practices; new animal drug for the proposed use (8) A written commitment to label, in a minor species outweigh its risks to distribute, and promote the new ani- the target animal, taking into account mal drug only in accordance with the the harm being caused by the absence index entry; of an approved or conditionally-ap- (9) The name and address of the con- proved new animal drug for the minor tact person or permanent-resident U.S. species in question, the written report shall: agent; and (1) Provide draft labeling that in- (10) A draft Freedom of Information cludes all conditions of use and limita- summary which includes the following tions of use of the new animal drug information: deemed necessary by the panel to as- (i) A general information section sure that the benefits of use of the new that contains the name and address of animal drug outweigh the risks, or pro- the requestor and a description of the vide narrative information from which drug, route of administration, indica- such labeling can be written by the re- tions, and recommended dosage. questor; and (ii) A list of the names and affili- (2) Include a recommendation regard- ations of the members of the qualified ing whether the new animal drug expert panel, not including their ad- should be limited to use under the pro- dresses or other contact information. fessional supervision of a licensed vet- (iii) A summary of the findings of the erinarian. qualified expert panel concerning the § 516.145 Content and format of a re- target animal safety and effectiveness quest for addition to the index. of the drug. (iv) Citations of all publicly-available (a) A requestor may request addition of a new animal drug to the index only literature considered by the qualified after the new animal drug has been expert panel. granted eligibility for indexing. (v) For an early life stage of a food- (b) A requestor shall submit two cop- producing minor species animal, a ies of a dated request signed by the au- human food safety summary. thorized contact for addition of a new (c) Upon specific request by FDA, the animal drug to the index that contains requestor shall submit the information the following: described in § 516.141 that it submitted (1) A copy of FDA’s determination of to the qualified expert panel. Any such eligibility issued under § 516.137; information not in English should be (2) A copy of FDA’s written deter- accompanied by an English trans- mination that the proposed qualified lation. expert panel meets the selection criteria provided for in § 516.141(b); § 516.147 Refuse to file a request for (3) A written report that meets the addition to the index. requirements of § 516.143; (a) If a request for addition to the (4) A proposed index entry that con- index contains all of the information tains the information described in required by § 516.145(b), FDA shall file § 516.157; it, and the filing date shall be the date (5) Proposed labeling, including representative labeling proposed to be FDA receives the request. used for Type B and Type C medicated (b) If a request for addition to the feeds if the drug is intended for use in index lacks any of the information re- the manufacture of medicated feeds; quired by § 516.145, FDA will not file it, (6) Anticipated annual distribution of but will inform the requestor in writ- the new animal drug, in terms of the ing within 30 days of receiving the re- total quantity of active ingredient, quest as to what information is lack- after indexing; ing.

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§ 516.149 Denying a request for addi- § 516.153 Notification of decision re- tion to the index. garding index listing. (a) FDA will deny a request for addi- (a) Within 180 days after the filing of tion to the index if it finds the fol- a request for addition of a new animal lowing: drug to the index, FDA shall grant or (1) The same drug in the same dosage deny the request and notify the re- form for the same intended use is al- questor of FDA’s decision in writing. ready approved or conditionally ap- (b) If FDA denies the request for ad- proved; dition of a new animal drug to the (2) On the basis of new information, index, FDA shall provide due notice the new animal drug no longer meets and an opportunity for an informal the conditions for eligibility for index- conference as described in § 516.123. A ing; decision of FDA to deny a request to (3) The request for indexing fails to index a new animal drug following an contain information required under the informal conference shall constitute provisions of § 516.145; final agency action subject to judicial (4) The qualified expert panel fails to review. meet any of the selection criteria listed in § 516.141(b); § 516.155 Labeling of indexed drugs. (5) The written report of the qualified (a) The labeling of an indexed drug expert panel and other information that is found to be eligible for indexing available to FDA is insufficient to per- under § 516.129(c)(7)(i) shall state, mit FDA to determine that the bene- prominently and conspicuously: ‘‘NOT fits of using the new animal drug for APPROVED BY FDA.—Legally marketed the proposed use in a minor species as an FDA indexed product. Extra-label outweigh its risks to the target ani- use is prohibited.’’ ‘‘This product is not to mal, taking into account the harm be used in animals intended for use as caused by the absence of an approved food for humans or other animals.’’ or conditionally-approved new animal 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 § 516.157 Publication of the index and statement of a material fact or omits content of an index listing. material information. (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. A printed copy can be obtained by writing to the FDA Division of Free- § 516.151 Granting a request for addi- dom of Information or by visiting tion to the index. FDA’s Division of Freedom of Informa- (a) FDA will grant the request for ad- tion Public Reading Room. dition of a new animal drug to the (b) The list will contain the following index if none of the reasons described information for each indexed drug: in § 516.149 for denying such a request (1) The name and address of the per- applies. son who holds the index listing; (b) When a request for addition of a (2) The name of the drug and the in- new animal drug to the index is grant- tended use and conditions of use for ed, FDA will notify the requestor in ac- which it is indexed; cordance with § 516.153. (3) Product labeling; and

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(4) Conditions and any limitations tice granting the request if all the fol- that FDA deems necessary regarding lowing conditions are met: use of the drug. (A) A request to modify the indexed drug providing a full explanation of the [72 FR 69121, Dec. 6, 2007, 76 FR 31470, June 1, 2011] basis for the modifications has been submitted, plainly marked on the mail- § 516.161 Modifications to indexed ing cover and on the request as follows: drugs. ‘‘Special indexing request— modifications being effected;’’ (a) After a drug is listed in the index, (B) The holder specifically informs certain modifications to the index list- FDA of the date on which such modi- ing may be requested. Any modifica- fications are to be effected and submits tion of an index listing may not cause two printed copies of any revised label- an indexed drug to be a different drug ing to be placed in use, and (or different combination of drugs) or a (C) All promotional labeling and all different dosage form. If such modifica- drug advertising are promptly revised tion is requested, FDA will notify the consistent with modifications made in 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 ad- (ii) Each modification described in vertising of false, misleading, or unsup- paragraph (b)(2)(i) of this section must ported indications for use or claims for go through the same review process as effectiveness. an original index listing and is subject (C) Changes in manufacturing meth- to the same standards for review. ods or controls required to correct (iii) Each submission of a request for product or manufacturing defects that a modification described in paragraph may result in serious adverse drug (b)(2)(i) of this section should contain events. only one type of modification unless (ii) The modifications described in one modification is actually neces- paragraph (b)(1)(i) of this section must sitated by another, such as a modifica- be submitted to the Director, OMUMS, tion of dose necessitated by a modifica- in the form of a request for modification of the concentration of an active tion of an indexed drug, and must con- ingredient. Submissions relating to ad- tain sufficient information to permit dition of an intended use for an exist- FDA to determine the need for the ing species or addition of a species modification and whether the modi- should be submitted separately, but fication appropriately addresses the each such submission may include mul- need. tiple additional intended uses and/or (iii) FDA will take no action against multiple additional species. an indexed drug or index holder solely (3) Minor changes. All modifications because modifications of the kinds de- other than those described in para- scribed in paragraph (b)(1)(i) of this graphs (b)(1) and (b)(2) of this section section are placed into effect by the including, but not limited to, formula- holder prior to receipt of a written no- tion, labeling, and manufacturing

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methods and controls (at the same (b) Upon receiving the necessary in- level of detail that these were de- formation to support a change of own- scribed in the request for determina- ership of a drug’s index file, FDA will tion of eligibility for indexing) must be update its publicly-available listing in submitted as part of the annual in- accordance with § 516.157. dexed drug experience report or as otherwise required by § 516.165. § 516.165 Records and reports. (c) When changes affect the index (a) Scope and purpose. (1) The record- listing, it will be updated accordingly. keeping and reporting requirements of this section apply to all holders of in- § 516.163 Change in ownership of an dexed drugs, including indexed drugs index file. intended for use in medicated feeds. (a) A holder may transfer ownership (2) A holder is not required to report of a drug’s index file to another person. information under this section if the (1) The former owner shall submit in holder has reported the same informa- writing to FDA a statement that all tion under § 514.80 of this chapter. 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 containing full records of all informa- (iv) Any records and reports under tion pertinent to the safety or effec- § 516.165; and tiveness of the indexed drug. Such (v) All correspondence with FDA rel- records must include information from evant to the indexed drug and its index foreign and domestic sources. listing. (2) The holder must, upon request (2) The new owner shall submit the from any authorized FDA officer or following information in writing to employee, at all reasonable times, per- FDA: mit such officer or employee to have (i) The date that the change in own- access to copy and to verify all such ership is effective; records. (ii) A statement that the new owner (c) Reporting requirements. (1) Three- has a complete copy of all documents day indexed drug field alert report. The listed in paragraph (a)(1) of this section holder must inform the appropriate to the extent that they exist at the FDA District Office or local FDA resi- time of the transfer of ownership; dent post of any product or manufac- (iii) A statement that the new owner turing defects that may result in seri- understands and accepts the respon- ous adverse drug events within 3 work- sibilities of a holder of an indexed drug; ing days of first becoming aware that (iv) The name and address of a new such a defect may exist. The holder primary contact person or permanent- may initially provide this information resident U.S. agent; and by telephone or other electronic com- (v) A list of labeling changes associ- munication means, with prompt writ- ated with the change of ownership ten followup. The mailing cover must (e.g., a new trade name) as draft label- be plainly marked ‘‘3–Day Indexed ing, with complete final printed label- Drug Field Alert Report.’’ ing to be submitted in the indexed drug (2) Fifteen-day indexed drug alert re- annual report in accordance with port. The holder must submit a report §§ 516.161 and 516.165. on each serious, unexpected adverse

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drug event, regardless of the source of (vi) Any other information pertinent the information. The holder must sub- to safety or effectiveness of the in- mit the report within 15 working days dexed drug not previously reported of first receiving the information. The under this section. mailing cover must be plainly marked (4) Distributor’s statement. At the time ‘‘15–Day Indexed Drug Alert Report.’’ of initial distribution of an indexed (3) Annual indexed drug experience re- drug by a distributor, the holder must port. The holder must submit this re- submit a report containing the fol- port every year on the anniversary lowing: date of the letter granting the request (i) The distributor’s current product for addition of the new animal drug to labeling. This must be identical to that the index, or within 60 days thereafter. in the index listing except for a dif- The report must contain data and in- ferent and suitable proprietary name formation for the full reporting period. (if used) and the name and address of Any previously submitted information the distributor. The name and address contained in the report must be identi- of the distributor must be preceded by fied as such. The holder may ask FDA an appropriate qualifying phrase such to change the date of submission and, as ‘‘manufactured for’’ or ‘‘distributed after approval of such request, file such by.’’ reports by the new filing date. The re- (ii) A signed statement by the dis- port must contain the following: tributor stating: (i) The number of distributed units of (A) The category of the distributor’s each size, strength, or potency (e.g., operations (e.g., wholesale or retail); (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. (a) After due notice to the holder of (iii) A summary of any changes made the index listing and an opportunity during the reporting period in the for an informal conference as described methods used in, and facilities and con- in § 516.123, FDA shall remove a new trols used for, manufacture, processing, animal drug from the index if FDA and packing. This information must be finds that: presented in the same level of detail (1) The same drug in the same dosage that it was presented in the request for form for the same intended use has determination of eligibility for index- been approved or conditionally ap- ing. Do not include changes that have proved; already been submitted under § 516.161. (2) The expert panel failed to meet (iv) Nonclinical laboratory studies the requirements in § 516.141; and clinical data not previously re- (3) On the basis of new information ported under this section. before FDA, evaluated together with (v) Adverse drug experiences not pre- the evidence available to FDA when viously reported under this section. the new animal drug was listed in the

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index, the benefits of using the new file shall be handled in accordance with animal drug for the indexed use do not the provisions of this section. outweigh its risks to the target ani- (b) The existence of an index file will mal, taking into account the harm not be disclosed by FDA before an caused by the absence of an approved index listing has been made public by or conditionally-approved new animal FDA, unless it has previously been pub- drug for the minor species in question; licly disclosed or acknowledged by the (4) Any of the conditions in requestor. § 516.133(a)(2), (5), or (6) are present; (c) If the existence of an index file (5) The manufacture of the new ani- has not been publicly disclosed or ac- mal drug is not in accordance with cur- knowledged, no data or information in rent good manufacturing practices; the index file are available for public (6) The labeling, distribution, or pro- disclosure. motion of the new animal drug is not (d) If the existence of an index file in accordance with the index listing; has been publicly disclosed or acknowl- (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.

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(4) Adverse reaction reports, product (h) For purposes of this regulation, experience reports, consumer com- safety and effectiveness data include plaints, and other similar data and in- all studies and tests of an animal drug formation, after deletion of the fol- on animals and all studies and tests on lowing: the animal drug for identity, stability, (i) Names and any information that purity, potency, and bioavailability. would identify the person using the (i) Safety and effectiveness data and product. information that have not been pre- (ii) Names and any information that viously disclosed to the public are would identify any third party involved available for public disclosure at the with the report, such as a veterinarian. time any of the following events occurs (5) A list of all active ingredients and unless extraordinary circumstances are any inactive ingredients previously shown: disclosed to the public as defined in (1) No work is being or will be under- § 20.81 of this chapter. taken to have the drug indexed in ac- (6) An assay method or other analyt- cordance with the request. ical method, unless it serves no regu- (2) A final determination is made latory or compliance purpose and is that the drug cannot be indexed and all shown to fall within the exemption es- legal appeals have been exhausted. tablished in § 20.61 of this chapter. (3) The drug has been removed from (7) All correspondence and written the index and all legal appeals have summaries of oral discussions relating been exhausted. to the index file, in accordance with (4) A final determination has been the provisions of part 20 of this chap- made that the animal drug is not a new ter. animal drug. (f) The following data and information in an index file are not available Subpart D [Reserved] for public disclosure unless they have been previously disclosed to the public Subpart E—Conditionally Ap- as defined in § 20.81 of this chapter, or proved New Animal Drugs For 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 confidential commercial or financial infor- SOURCE: 72 FR 57200, Oct. 9, 2007, unless mation as defined in § 20.61 of this chap- otherwise noted. ter: § 516.1318 Masitinib. (1) Manufacturing methods or processes, including quality control proce- (a) Specifications. Each tablet con- dures. tains 50 or 150 milligrams (mg) (2) Production, sales, distribution, masitinib mesylate. and similar data and information, ex- (b) Sponsor. See No. 052913 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. 12.5 mg/kilograms (5.7 mg/lb) data or information which is not avail- of body weight daily. able for public disclosure under this (2) Indications for use. For the treat- provision is available for public disclo- ment of nonresectable Grade II or III sure. cutaneous mast cell tumors in dogs (3) Quantitative or semiquantitative that have not previously received ra- formulas. diotherapy and/or chemotherapy except (g) Subject to the disclosure provi- corticosteroids. sions of this section, the agency shall (3) Limitations. Federal law restricts regard the contents of an index file as this drug to use by or on the order of a confidential information unless specifi- licensed veterinarian. It is a violation cally notified in writing by the holder of Federal law to use this product of the right to disclose, to reference, or other than as directed in the labeling. otherwise utilize such information on [76 FR 6327, Feb. 4, 2011, as amended at 77 FR behalf of another named person. 35837, June 15, 2012]

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§ 516.1684 Paclitaxel. 520.88h Amoxicillin trihydrate and clavulanate potassium for oral suspen- (a) Specifications. Each vial of powder sion. contains 60 milligrams (mg) paclitaxel. 520.90 Ampicillin oral dosage forms. Each milliliter of constituted solution 520.90a Ampicillin capsules. contains 1 mg paclitaxel. 520.90b Ampicillin trihydrate tablets. (b) Sponsor. See No. 052818 in 520.90c Ampicillin trihydrate capsules. 510.600(c) of this chapter. 520.90d Ampicillin trihydrate for oral suspension. (c) Conditions of use in dogs—(1) 520.90e Ampicillin trihydrate soluble pow- Amount. Administer 150 mg per square der. meter of body surface area intra- 520.90f Ampicillin trihydrate boluses. venously over 15 to 30 minutes, once 520.100 Amprolium. every 3 weeks, for up to 4 doses. 520.110 Apramycin sulfate soluble powder. (2) Indications for use. For the treat- 520.154 Bacitracin oral dosage forms. ment of nonresectable stage III, IV, or 520.154a Bacitracin methylene disalicylate. V mammary carcinoma in dogs that 520.154b Bacitracin methylene disalicylate and streptomycin sulfate powder. have not received previous chemo- 520.154c Bacitracin zinc soluble powder. therapy or radiotherapy. For the treat- 520.222 Bunamidine hydrochloride. ment of resectable and nonresectable 520.246 Butorphanol tartrate tablets. squamous cell carcinoma in dogs that 520.260 n-Butyl chloride. have not received previous chemo- 520.300 Cambendazole oral dosage forms. therapy or radiotherapy. 520.300a Cambendazole suspension. (3) Limitations. Federal law restricts 520.300b Cambendazole pellets. 520.300c Cambendazole paste. this drug to use by or on the order of a 520.309 Carprofen. licensed veterinarian. It is a violation 520.310 Caramiphen ethanedisulfonate and of Federal law to use this product ammonium chloride tablets. other than as directed in the labeling. 520.312 Carnidazole tablets. 520.314 Cefadroxil. [79 FR 18158, Apr. 1, 2014] 520.370 Cefpodoxime tablets. 520.376 Cephalexin. PART 520—ORAL DOSAGE FORM 520.390 Chloramphenicol oral dosage forms. 520.390a Chloramphenicol tablets. NEW ANIMAL DRUGS 520.390b Chloramphenicol capsules. 520.390c Chloramphenicol palmitate oral Sec. suspension. 520.23 Acepromazine. 520.420 Chlorothiazide tablets and boluses. 520.28 Acetazolamide sodium soluble pow- 520.434 Chlorphenesin carbamate tablets. der. 520.441 Chlortetracycline powder. 520.38 Albendazole oral dosage forms. 520.443 Chlortetracycline tablets and 520.38a Albendazole suspension. boluses. 520.38b Albendazole paste. 520.445 Chlortetracycline and 520.43 Afoxolaner. sulfamethazine powder. 520.48 Altrenogest. 520.446 Clindamycin capsules and tablets. 520.62 Aminopentamide hydrogen sulphate 520.447 Clindamycin solution. tablets. 520.452 Clenbuterol syrup. 520.82 Aminopropazine fumarate oral dosage 520.455 Clomipramine tablets. forms. 520.462 Clorsulon drench. 520.82a Aminopropazine fumarate tablets. 520.522 Cyclosporine. 520.82b Aminopropazine fumarate, neomy- 520.530 Cythioate oral liquid. cin sulfate tablets. 520.531 Cythioate tablets. 520.88 Amoxicillin oral dosage forms. 520.534 Decoquinate. 520.88a Amoxicillin trihydrate film-coated 520.538 Deracoxib. tablets. 520.540 Dexamethasone oral dosage forms. 520.88b Amoxicillin trihydrate for oral sus- 520.540a Dexamethasone powder. pension. 520.540b Dexamethasone tablets and 520.88c Amoxicillin trihydrate oral suspen- boluses. sion. 520.540c Dexamethasone chewable tablets. 520.88d Amoxicillin trihydrate soluble pow- 520.550 Glucose/glycine/electrolyte. der. 520.563 Diatrizoate meglumine and dia- 520.88e Amoxicillin trihydrate boluses. trizoate sodium oral solution. 520.88f Amoxicillin trihydrate tablets. 520.580 Dichlorophene and toluene. 520.88g Amoxicillin trihydrate and 520.581 Dichlorophene tablets. clavulanate potassium film-coated tab- 520.600 Dichlorvos. lets. 520.606 Diclazuril.

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520.608 Dicloxacillin sodium monohydrate 520.1196 Ivermectin and pyrantel pamoate capsules. chewable tablets. 520.620 Diethylcarbamazine oral dosage 520.1197 Ivermectin sustained-release bolus. forms. 520.1198 Ivermectin and praziquantel paste. 520.622 Diethylcarbamazine citrate oral dos- 520.1199 Ivermectin, pyrantel, and age forms. praziquantel tablets. 520.622a Diethylcarbamazine citrate tablets. 520.1200 Ivermectin, fenbendazole, and 520.622b Diethylcarbamazine citrate syrup. praziquantel tablets. 520.622c Diethylcarbamazine citrate chew- 520.1204 Kanamycin, bismuth subcarbonate, able tablets. activated attapulgite. 520.623 Diethylcarbamazine citrate, 520.1242 Levamisole. oxibendazole chewable tablets. 520.1242a Levamisole powder. 520.645 Difloxacin. 520.1242b Levamisole hydrochloride tablet 520.666 Dirlotapide. or oblet (bolus). 520.763 Dithiazanine iodide oral dosage 520.1242c Levamisole hydrochloride and pi- forms. perazine dihydrochloride. 520.763a Dithiazanine iodide tablets. 520.1242d Levamisole resinate. 520.763b Dithiazanine iodide powder. 520.1242e Levamisole hydrochloride effer- 520.763c Dithiazanine iodide and piperazine vescent tablets. citrate suspension. 520.1242f Levamisole hydrochloride gel. 520.766 Domperidone. 520.1242g Levamisole resinate and famphur 520.784 Doxylamine succinate tablets. paste. 520.804 Enalapril tablets. 520.1263 Lincomycin. 520.812 Enrofloxacin. 520.1263a Lincomycin hydrochloride 520.816 Epsiprantel tablets. monohydrate tablets and sirup. 520.823 Erythromycin phosphate. 520.1263b [Reserved] 520.852 Estriol. 520.1263c Lincomycin powder. 520.863 Ethylisobutrazine hydrochloride 520.1265 Lincomycin and spectinomycin tablets. powder. 520.870 Etodolac. 520.1284 Sodium liothyronine tablets. 520.903 Febantel oral dosage forms. 520.1288 Lufenuron tablets. 520.903a Febantel paste. 520.1289 Lufenuron suspension. 520.903b Febantel suspension. 520.1310 Marbofloxacin tablets. 520.903c [Reserved] 520.1315 Maropitant. 520.903d Febantel-praziquantel paste. 520.1320 Mebendazole oral. 520.903e Febantel tablets. 520.1326 Mebendazole and trichlorfon oral 520.905 Fenbendazole oral dosage forms. dosage forms. 520.905a Fenbendazole suspension. 520.1326a Mebendazole and trichlorfon pow- 520.905b Fenbendazole granules. der. 520.905c Fenbendazole paste. 520.1326b Mebendazole and trichlorfon paste. 520.905d Fenbendazole powder. 520.1330 Meclofenamic acid granules. 520.905e Fenbendazole blocks. 520.1331 Meclofenamic acid tablets. 520.928 Firocoxib tablets. 520.1341 Megestrol acetate tablets. 520.930 Firocoxib paste. 520.1367 Meloxicam. 520.955 Florfenicol. 520.1372 Methimazole. 520.960 Flumethasone tablets. 520.1380 Methocarbamol tablets. 520.970 Flunixin. 520.1408 Methylprednisolone tablets. 520.980 Fluoxetine. 520.1409 Methylprednisolone, aspirin tab- 520.1010 Furosemide. lets. 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. 520.1100 Griseofulvin. 520.1447 Milbemycin oxime, lufenuron, and 520.1120 Haloxon oral dosage forms. praziquantel tablets. 520.1120a Haloxon drench. 520.1450 Morantel tartrate oral dosage 520.1120b Haloxon boluses. forms. 520.1130 Hetacillin. 520.1450a Morantel tartrate bolus. 520.1157 Iodinated casein tablets. 520.1450b Morantel tartrate cartridge. 520.1158 Iodochlorhydroxyquin boluses. 520.1450c Morantel tartrate sustained-re- 520.1182 Iron dextran suspension. lease trilaminate cylinder/sheet. 520.1192 Ivermectin paste. 520.1451 Moxidectin tablets. 520.1193 Ivermectin tablets and chewables. 520.1452 Moxidectin gel. 520.1194 Ivermectin meal. 520.1453 Moxidectin and praziquantel gel. 520.1195 Ivermectin liquid. 520.1454 Moxidectin solution.

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520.1468 Naproxen granules. 520.2002 Propiopromazine hydrochloride. 520.1484 Neomycin. 520.2041 Pyrantel pamoate chewable tablets. 520.1510 Nitenpyram tablets. 520.2042 Pyrantel pamoate tablets. 520.1604 Oclacitinib. 520.2043 Pyrantel pamoate suspension. 520.1615 Omeprazole. 520.2044 Pyrantel pamoate paste. 520.1616 Orbifloxacin tablets.. 520.2045 Pyrantel tartrate powder; pyrantel 520.1618 Orbifloxacin suspension. tartrate pellets. 520.1628 Oxfendazole powder and pellets. 520.2075 Robenacoxib. 520.1629 Oxfendazole paste. 520.2098 Selegiline hydrochloride tablets. 520.1630 Oxfendazole suspension. 520.2100 Selenium, vitamin E capsules. 520.1631 Oxfendazole and trichlorfon paste. 520.2123 Spectinomycin oral dosage forms. 520.1638 Oxibendazole paste. 520.2123a Spectinomycin tablets. 520.1640 Oxibendazole suspension. 520.2123b Spectinomycin powder. 520.1660 Oxytetracycline. 520.2123c Spectinomycin solution. 520.1660a Oxytetracycline and carbomycin 520.2130 Spinosad. in combination. 520.2134 Spinosad and milbemycin. 520.1660b Oxytetracycline hydrochloride 520.2150 Stanozolol oral dosage forms. capsules. 520.2150a Stanozolol tablets. 520.1660c Oxytetracycline hydrochloride 520.2150b Stanozolol chewable tablets. tablets/boluses. 520.2158 Streptomycin/dihydrostreptomycin 520.1660d Oxytetracycline powder. oral dosage forms. 520.1696 Penicillin. 520.2158a Streptomycin sulfate oral solu- 520.1696a [Reserved] tion. 520.1696b Penicillin G powder. 520.2158b Dihydrostreptomycin tablets. 520.1696c Penicillin V powder. 520.2158c Dihydrostreptomycin oral suspen- 520.1696d Penicillin V tablets. sion. 520.1705 Pergolide. 520.2160 Styrylpyridinium, 520.1720 Phenylbutazone oral dosage forms. diethylcarbamazine oral dosage forms. 520.1720a Phenylbutazone tablets and 520.2170 Sulfabromomethazine sodium boluses. boluses. 520.1720b Phenylbutazone granules. 520.2184 Sodium sulfachloropyrazine 520.1720c Phenylbutazone paste. monohydrate. 520.1720d Phenylbutazone gel. 520.2200 Sulfachlorpyridazine. 520.1720e Phenylbutazone powder. 520.2215 Sulfadiazine/pyrimethamine sus- 520.1760 Phenylpropanolamine. pension. 520.1780 Pimobendan. 520.2218 Sulfamerazine, sulfamethazine, and 520.1802 Piperazine-carbon disulfide complex sulfaquinoxaline powder. oral dosage forms. 520.2220 Sulfadimethoxine oral dosage 520.1802a Piperazine-carbon disulfide com- forms. plex suspension. 520.2220a Sulfadimethoxine oral solution 520.1802b Piperazine-carbon disulfide com- and soluble powder. plex boluses. 520.2220b Sulfadimethoxine tablets and 520.1802c Piperazine-carbon disulfide com- boluses. plex with phenothiazine suspension. 520.2220c Sulfadimethoxine oral suspension. 520.1803 Piperazine citrate capsules. 520.2220d Sulfadimethoxine-ormetoprim 520.1804 Piperazine phosphate capsules. tablets. 520.1805 Piperazine phosphate with thenium 520.2240 Sulfaethoxypyridazine. closylate tablets. 520.2240a Sulfaethoxypyridazine drinking 520.1806 Piperazine suspension. water. 520.1807 Piperazine. 520.2240b Sulfaethoxypyridazine tablets. 520.1840 Poloxalene. 520.2260 Sulfamethazine oral dosage forms. 520.1846 Polyoxyethylene (23) lauryl ether 520.2260a Sulfamethazine oblet, tablet, and blocks. bolus. 520.1855 Ponazuril. 520.2260b Sulfamethazine sustained-release 520.1860 Pradofloxacin. boluses. 520.1870 Praziquantel tablets. 520.2260c Sulfamethazine sustained-release 520.1871 Praziquantel and pyrantel. tablets. 520.1872 Praziquantel, pyrantel pamoate, 520.2261 Sulfamethazine sodium oral dosage and febantel tablets. forms. 520.1880 Prednisolone tablets. 520.2261a Sulfamethazine solution. 520.1900 Primidone tablets. 520.2261b Sulfamethazine powder. 520.1920 Prochlorperazine, isopropamide sus- 520.2280 Sulfamethizole and methenamine tained release capsules. mandelate tablets. 520.1921 Prochlorperazine, isopropamide, 520.2325 Sulfaquinoxaline oral dosage forms. with neomycin sustained-release cap- 520.2325a Sulfaquinoxaline drinking water. sules. 520.2325b Sulfaquinoxaline drench. 520.1962 Promazine hydrochloride. 520.2330 Sulfisoxazole tablets.

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520.2340 Tepoxalin. § 520.23 Acepromazine. 520.2345 Tetracycline. 520.2345a Tetracycline hydrochloride cap- (a) Specifications. Each tablet con- sules. tains 5, 10, or 25 milligrams (mg) 520.2345b Tetracycline tablets. acepromazine maleate. 520.2345c Tetracycline boluses. (b) Sponsors. See No. 000010 in 520.2345d Tetracycline powder. § 510.600(c) of this chapter. 520.2345e Tetracycline oral liquid. (c) Conditions of use(1) Dogs—(i) 520.2345f Tetracycline phosphate complex Amount. 0.25 to 1.0 mg per pound (/lb) and sodium novobiocin capsules. body weight orally. 520.2345g Tetracycline hydrochloride and so- (ii) Indications for use. As an aid in dium novobiocin tablets. tranquilization and as a preanesthetic 520.2345h Tetracycline hydrochloride, so- agent. dium novobiocin, and prednisolone tablets. (iii) Limitations. Federal law restricts 520.2362 Thenium closylate tablets. this drug to use by or on the order of a 520.2380 Thiabendazole oral dosage forms. licensed veterinarian. 520.2380a Thiabendazole top dressing and (2) Cats—(i) Amount. 0.5 to 1.0 mg/lb mineral protein block. body weight orally. 520.2380b Thiabendazole drench or oral (ii) Indications for use. As a tranquil- paste. izer. 520.2380c Thiabendazole bolus. (iii) Limitations. Federal law restricts 520.2380d Thiabendazole, piperazine citrate this drug to use by or on the order of a suspension. licensed veterinarian. 520.2380e Thiabendazole with trichlorfon. 520.2380f Thiabendazole, piperazine phos- [75 FR 10165, Mar. 5, 2010] phate powder. 520.2455 Tiamulin. § 520.28 Acetazolamide sodium soluble 520.2471 Tilmicosin. powder. 520.2473 Tioxidazole oral dosage forms. (a) Specifications. The drug is in a 520.2473a Tioxidazole granules. powder form containing acetazolamide 520.2473b Tioxidazole paste. sodium, USP equivalent to 25 percent 520.2475 Toceranib. 520.2481 Triamcinolone acetonide tablets. acetazolamide activity. 520.2482 Triamcinolone acetonide oral pow- (b) Sponsor. See No. 053501 in der. § 510.600(c) of this chapter. 520.2483 Triamcinolone. (c) Conditions of use. (1) It is used in 520.2520 Trichlorfon oral dosage forms. dogs as an aid in the treatment of mild 520.2520b Trichlorfon and atropine. congestive heart failure and for rapid 520.2520e Trichlorofon boluses. reduction of intraocular pressure.1 520.2520f Trichlorofon granules. (2) It is administered orally at a dos- 520.2520g Trichlorfon, phenothiazine, and pi- age level of 5 to 15 milligrams per perazine dihydrochloride powder. pound of body weight daily.1 520.2582 Triflupromazine hydrochloride tab- (3) For use only by or on the order of lets. 1 520.2598 Trilostane. a licensed veterinarian. 520.2604 Trimeprazine tartrate and prednis- [40 FR 13838, Mar. 27, 1975, as amended at 67 olone tablets. FR 78355, Dec. 24, 2002. Redesignated at 78 FR 520.2605 Trimeprazine tartrate and prednis- 66264, Nov. 5, 2013] olone capsules. 520.2610 Trimethoprim and sulfadiazine tab- § 520.38 Albendazole oral dosage lets. forms. 520.2611 Trimethoprim and sulfadiazine paste. § 520.38a Albendazole suspension. 520.2612 Trimethoprim and sulfadiazine sus- (a) Specifications. Each milliliter of pension. 520.2613 Trimethoprim and sulfadiazine suspension contains 45.5 milligrams powder. 520.2640 Tylosin. 1 These conditions are NAS/NRC reviewed 520.2645 Tylvalosin. and deemed effective. Applications for these uses need not include effectiveness data as AUTHORITY: 21 U.S.C. 360b. specified by § 514.111 of this chapter, but may SOURCE: 40 FR 13838, Mar. 27, 1975, unless require bioequivalency and safety informa- otherwise noted. tion.

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(mg) (4.55 percent) or 113.6 mg (11.36 adult and fourth stage larvae of intes- percent) albendazole. tinal worms (thread-necked intestinal (b) Sponsor. See No. 000069 in § 510.600 worm (Nematodirus spathiger and N. of this chapter. filicollis), Cooper’s worm (Cooperia (c) Related tolerances. See § 556.34 of oncophora), bankrupt worm this chapter. (Trichostrongylus colubriformis), nodular (d) Special considerations. See § 500.25 worm (Oesophagostomum columbianum), of this chapter. and large-mouth bowel worm (Chabertia (e) Conditions of use(1) Cattle. Admin- ovina)); adult and larval stages of ister 11.36 percent suspension: lungworms (Dictyocaulus filaria). (i) Amount. 4.54 mg/pound (lb) body (iii) Limitations. Do not slaughter weight (10 mg/kilogram (kg)) as a sin- within 7 days of last treatment. Do not gle oral dose using dosing gun or dos- administer to ewes during first 30 days ing syringe. of pregnancy or for 30 days after re- (ii) Indications for use. For removal moval of rams. and control of adult liver flukes (3) Goats. Administer 11.36 percent (Fasciola hepatica); heads and segments suspension: of tapeworms (Moniezia benedeni and M. (i) Amount. 4.54 mg/lb body weight (10 expansa); adult and 4th stage larvae of mg/kg) as a single oral dose using dos- stomach worms (brown stomach worms ing gun or dosing syringe. including 4th stage inhibited larvae (ii) Indications for use. For the treat- (Ostertagia ostertagi), barberpole worm ment of adult liver flukes (Fasciola he- (Haemonchus contortus and H. placei), patica) in nonlactating goats. small stomach worm (Trichostrongylus (iii) Limitations. Do not slaughter axei)); adult and 4th stage larvae of in- within 7 days of last treatment. Do not testinal worms (thread-necked intes- administer to does during the first 30 tinal worm (Nematodirus spathiger and days of pregnancy or for 30 days after N. helvetianus), small intestinal worm removal of bucks. (Cooperia punctata and C. oncophora)); [73 FR 11027, Feb. 29, 2008. Redesignated at 78 adult stages of intestinal worms FR 66264, Nov. 5, 2013] (hookworm (Bunostomum phlebotomum), bankrupt worm (Trichostrongylus § 520.38b Albendazole paste. colubriformis), nodular worm (a) Specifications. The product con- (Oesophagostomum radiatum)); adult and tains 30 percent albendazole. 4th stage larvae of lungworms (b) Sponsor. See No. 000069 in (Dictyocaulus viviparus). § 510.600(c) of this chapter. (iii) Limitations. Do not slaughter (c) Related tolerances. See § 556.34 of within 27 days of last treatment. Do this chapter. not use in female dairy cattle of breed- (d) Conditions of use in cattle(1) ing age: Do not administer to female Amount. Equivalent to 4.54 milligrams cattle during first 45 days of pregnancy per 1 pound of body weight (10 milli- or for 45 days after removal of bulls. grams per kilogram). (2) Sheep. Administer 4.45 or 11.36 per- (2) Indications for use. For removal cent suspension: and control of the following internal (i) Amount. 3.4 mg/lb body weight (7.5 parasites of cattle: adult liver flukes mg/kg) as a single oral dose using dos- (Fasciola hepatica); heads and segments ing gun or dosing syringe. of tapeworms (Moniezia benedeni, M. (ii) Indications for use. For removal expansa); adult and 4th stage larvae of and control of adult liver flukes stomach worms (brown stomach worms (Fasciola hepatica and Fascioloides including 4th stage inhibited larvae magna); heads and segments of common (Ostertagia ostertagi); barberpole worm tapeworms (Moniezia expansa) and (Haemonchus contortus, H. placei); small fringed tapeworm (Thysanosoma stomach worm (Trichostrongylus axei)); actinioides); adult and fourth stage lar- adult and 4th stages larvae of intes- vae of stomach worms (brown stomach tinal worms (thread-necked intestinal worm (Ostertagia circumcinta and worm (Nematodirus spathiger, N. Marshallagia marshalli), barberpole helvetianus); small intestinal worm worm (Haemonchus contortus), small (Cooperia punctata and C. oncophora)); stomach worm (Trichostrongylus axei)); adult stages of intestinal worms

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(hookworm (Bunostomum phlebotmum); weight (0.044 mg/kg) daily for 15 con- bankrupt worm (Trichostrongylus secutive days. colubriformis), nodular worm (ii) Indications for use. For suppres- (Oesophagostomum radiatum)); adult and sion of estrus in mares. 4th stage larvae of lungworms (iii) Limitations. Do not use in horses (Dictyocaulus viviparus). intended for human consumption. Fed- (3) Limitations. Administer as a single eral law restricts this drug to use by or oral dose. Do not slaughter within 27 on the order of a licensed veterinarian. days of last treatment. Do not use in (2) Swine—(i) Amount. Administer 6.8 female dairy cattle of breeding age. Do mL (15 mg altrenogest) per gilt once not administer to female cattle during daily for 14 consecutive days by top- first 45 days of pregnancy or for 45 days dressing on a portion of each gilt’s after removal of bulls. Consult your daily feed. veterinarian for assistance in the diagnosis, treatment, and control of para- (ii) Indications for use. For synchroni- sitism. zation of estrus in sexually mature gilts that have had at least one estrous [54 FR 51385, Dec. 15, 1989, as amended at 56 cycle. FR 50653, Oct. 8, 1991; 60 FR 55658, Nov. 2, (iii) Limitations. Do not use in gilts 1995. Redesignated at 78 FR 66264, Nov. 5, 2013.] having a previous or current history of uterine inflammation (i.e., acute, § 520.43 Afoxolaner. subacute or chronic endometritis). (a) Specifications. Each chewable tab- Gilts must not be slaughtered for let contains 11.3, 28.3, 68, or 136 milli- human consumption for 21 days after grams (mg) afoxolaner. the last treatment. (b) Sponsor. See No. 050604 in [66 FR 47960, Sept. 17, 2001, as amended at 68 § 510.600(c) of this chapter. FR 62006, Oct. 31, 2003; 72 FR 9455, Feb. 21, (c) Conditions of use(1) Amount. Ad- 2008; 74 FR 61516, Nov. 25, 2009; 77 FR 32012, minister orally once a month at a min- May 31, 2012] imum dosage of 1.14 mg/pound (lb) (2.5 mg/kilogram (kg)). § 520.62 Aminopentamide hydrogen (2) Indications for use. For the treat- sulphate tablets. ment and prevention of flea infesta- (a) Chemical name. 4- tions (Ctenocephalides felis), and the (Dimethylamino)-2,2- treatment and control of American dog diphenylvaleramide hydrogen sulfate. tick (Dermacentor variabilis) infesta- (b) Specifications. Each tablet con- tions in dogs and puppies 8 weeks of tains 0.2 milligram of the drug. age and older, weighing 4 pounds of (c) Sponsor. See No. 000856 in body weight or greater, for 1 month. § 510.600(c) of this chapter. (3) Limitations. Federal law restricts this drug to use by or on the order of a (d) Conditions of use. (1) It is intended licensed veterinarian. for use in dogs and cats only for the treatment of vomiting and/or diarrhea, [78 FR 66264, Nov. 5, 2013] nausea, acute abdominal visceral spasm, pylorospasm, or hypertrophic § 520.48 Altrenogest. gastritis. (a) Specifications. Each milliliter (mL) of solution contains 2.2 milli- NOTE: Not for use in animals with glau- grams (mg) altrenogest. coma because of the occurrence of mydriasis. (b) Sponsors. See sponsor listings in (2) Dosage is administered by oral § 510.600(c) of this chapter: tablet every 8 to 12 hours, as follows: (1) No. 000061 for use as in paragraph (d) of this section. Weight of animal in pounds Dosage in (2) No. 013744 for use as in paragraph milligrams (d)(1) of this section. Up to 10 ...... 0.1 (c) Tolerances. See § 556.36 of this 11 to 20 ...... 0.2 chapter. 21 to 50 ...... 0.3 (d) Conditions of use—(1) Horses—(i) 51 to 100 ...... 0.4 Amount. 1.0 mL per 110 pounds body Over 100 ...... 0.5

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Dosage may be gradually increased up (2) It is administered at a dosage to a maximum of five times the sug- level of one to two tablets per 10 gested dosage. Oral administration of pounds of body weight twice daily for 3 tablets may be preceded by subcuta- days.1 neous or intramuscular use of the (3) Federal law restricts this drug to injectable form of the drug. use by or on the order of a licensed vet- (3) For use only by or on the order of erinarian.1 a licensed veterinarian. [40 FR 13838, Mar. 27, 1975, as amended at 46 [40 FR 13838, Mar. 27, 1975, as amended at 53 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; FR 27851, July 25, 1988] 62 FR 61624, Nov. 19, 1997]

§ 520.82 Aminopropazine fumarate oral § 520.88 Amoxicillin oral dosage forms. dosage forms. § 520.88a Amoxicillin trihydrate film- § 520.82a Aminopropazine fumarate coated tablets. tablets. (a) Specifications. Each tablet con- (a) Specifications. The drug is in tab- tains amoxicillin trihydrate equivalent let form. Each tablet contains to 50, 100, 150, 200, or 400 milligrams of aminopropazine fumarate equivalent to amoxicillin. 25 milligrams of aminopropazine base. (b) Sponsor. See No. 000069 in (b) See No. 000061 in Sponsor. § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) (c) Conditions of use. (1) The drug is Amount. 5 milligrams per pound of body used in dogs and cats for reducing ex- weight, twice a day. cessive smooth muscle contractions, such as occur in urethral spasms asso- (ii) Indications for use. Treatment of ciated with urolithiasis.1 infections of the respiratory tract (ton- (2) It is administered at a dosage sillitis, tracheobronchitis), genito- level of 1 to 2 milligrams per pound of urinary tract (cystitis), gastro- body weight. The dosage can be re- intestinal tract (bacterial peated every 12 hours, as indicated.1 gastroenteritis), and soft tissues (ab- (3) Not for use in animals intended scesses, lacerations, wounds), caused for food purposes. by susceptible strains of Staphylococcus (4) For use only by or on the order of aureus, Streptococcus spp., Escherichia a licensed veterinarian.1 coli, Proteus mirabilis, and bacterial dermatitis caused by S. aureus, Strepto- [40 FR 13838, Mar. 27, 1975, as amended at 46 coccus spp., and P. mirabilis. FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; (iii) Limitations. Administer for 5 to 7 62 FR 61624, Nov. 19, 1997] days or 48 hours after all symptoms § 520.82b Aminopropazine fumarate, have subsided. If no improvement is neomycin sulfate tablets. seen in 5 days, review diagnosis and change therapy. Federal law restricts (a) Specifications. The drug is in tab- this drug to use by or on the order of a let form. Each tablet contains both licensed veterinarian. aminopropazine fumarate equivalent to (2) Cats—(i) Amount. 50 milligrams (5 25 milligrams of aminopropazine base to 10 milligrams per pound of body and neomycin sulfate equivalent to 50 weight) once a day. milligrams of neomycin base. (ii) Treatment of (b) Sponsor. See No. 000061 in Indications for use. § 510.600(c) of this chapter. infections caused by susceptible organisms as follows: upper respiratory (c) Conditions of use. (1) The drug is used in dogs to control bacterial diar- tract due to S. aureus, Streptococcus rhea caused by organisms susceptible spp., and E. coli; genitourinary tract to neomycin and to reduce smooth (cystitis) due to S. aureus, Streptococcus spp., E. coli, and P. mirabilis; gastro- muscle contractions.1 intestinal tract due to E. coli; and skin and soft tissue (abscesses, lacerations, 1 These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as require bioequivalency and safety informa- specified by § 514.111 of this chapter, but may tion.

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and wounds) due to S. aureus, Strepto- spp.; gastrointestinal tract due to E. coccus spp., E. coli, and Pasteurella coli, Proteus spp., Staphylococcus spp., multocida. and Streptococcus spp.; skin and soft tis- (iii) Limitations. Administer for 5 to 7 sue (abscesses, lacerations, and days or 48 hours after all symptoms wounds) due to Staphylococcus spp., have subsided. If no improvement is Streptococcus spp., E. coli, and seen in 5 days, review diagnosis and Pasteurella multocida. change therapy. Federal law restricts (C) Limitations. Use for 5 to 7 days or this drug to use by or on the order of a 48 hours after all symptoms have sub- licensed veterinarian. sided. Federal law restricts this drug to [57 FR 37319, Aug. 18, 1992, as amended at 60 use by or on the order of a licensed vet- FR 55658, Nov. 2, 1995] erinarian. (2) [Reserved] § 520.88b Amoxicillin trihydrate for (c) Sponsors. See Nos. 000856 and oral suspension. 051311 in § 510.600(c) of this chapter. (a) Specifications. When reconstituted, (1) Conditions of use. Dogs—(i) Amount. each milliliter contains amoxicillin 5 milligrams per pound of body weight trihydrate equivalent to 50 milligrams twice daily. of amoxicillin. (ii) Indications for use. Treatment of (b) Sponsor. See No. 000069 in bacterial dermatitis due to S. aureus, § 510.600(c) of this chapter. Streptococcus spp., Staphylococcus spp., (1) Conditions of use—(i) Dogs—(A) and E. coli, and soft tissue infections Amount. 5 milligrams per pound of body (abscesses, wounds, lacerations) due to weight twice daily. S. aureus, Streptococcus spp., E. coli, P. (B) Indications for use. Treatment of mirabilis and Staphylococcus spp. infections caused by susceptible strains (iii) Limitations. Use for 5 to 7 days. of organisms as follows: respiratory Continue for 48 hours after all symp- tract (tonsillitis, tracheobronchitis) toms have subsided. If no improvement caused by Staphylococcus aureus, Strep- is seen in 5 days, review diagnosis and tococcus spp., Escherichia coli, and Pro- change therapy. Federal law restricts teus mirabilis; genitourinary tract (cys- this drug to use by or on the order of a titis) caused by S. aureus, Streptococcus licensed veterinarian. spp., E. coli, and P. mirabilis; gastro- (2) [Reserved] intestinal tract (bacterial gastroenteritis) caused by S. aureus, [57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. Streptococcus spp., E. coli, and P. 15, 1992, as amended at 60 FR 55658, Nov. 2, mirabilis; bacterial dermatitis caused 1995; 62 FR 13302, Mar. 20, 1997; 67 FR 67521, by S. aureus, Streptococcus spp., and P. Nov. 6, 2002; 68 FR 54658, Sept. 18, 2003; 68 FR 55824, Sept. 29, 2003] mirabilis; and soft tissues (abscesses, lacerations, and wounds) caused by S. § 520.88c Amoxicillin trihydrate oral aureus, Streptococcus spp., E. coli, and P. suspension. mirabilis. (C) Limitations. Use for 5 to 7 days or (a) Specifications. Each 0.8-milliliter 48 hours after all symptoms have sub- dose contains amoxicillin trihydrate sided. Federal law restricts this drug to equivalent to 40 milligrams of use by or on the order of a licensed vet- amoxicillin. erinarian. (b) Sponsor. See No. 000069 in (ii) Cats—(A) Amount. 50 milligrams § 510.600(c) of this chapter. (5 to 10 milligrams per pound) once (c) Related tolerances. See § 556.510 of daily. this chapter. (B) Indications for use. Treatment of (d) Conditions of use. Swine(1) Amount. infections caused by susceptible strains 40 milligrams orally, twice a day using of organisms as follows: upper res- a dosing pump. piratory tract due to Staphylococcus (2) Indications for use. Treatment of spp., Streptococcus spp., Hemophilus baby pigs under 10 pounds for porcine spp., E. coli, Pasteurella spp., and P. colibacillosis caused by Escherichia coli mirabilis; genitourinary tract (cystitis) susceptible to amoxicillin. due to S. aureus, Streptococcus spp., E. (3) Limitations. Treat animals for 48 coli, P. mirabilis, and Corynebacterium hours after all symptoms have subsided

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but not beyond 5 days. Do not slaugh- tible Escherichia coli in preruminating ter during treatment or for 15 days calves including veal calves. after latest treatment. Federal law re- (3) Limitations. For oral use in stricts this drug to use by or on the preruminating calves including veal order of a licensed veterinarian. calves only, not for use in other ani- [57 FR 37319, Aug. 18, 1992, as amended at 60 mals which are raised for food produc- FR 55658, Nov. 2, 1995] tion. Treatment should be continued for 48 hours after all symptoms have § 520.88d Amoxicillin trihydrate solu- subsided but not to exceed 5 days. Do ble powder. not slaughter animals during treat- (a) Specifications. Each gram contains ment or for 20 days after the latest amoxicillin trihydrate equivalent to treatment. Federal law restricts this 115.4 milligrams of amoxicillin. drug to use by or on the order of a li- (b) Sponsor. See No. 000069 in censed veterinarian. § 510.600(c) of this chapter. [57 FR 37320, Aug. 18, 1992, as amended at 60 (c) Related tolerances. See § 556.38 of FR 55659, Nov. 2, 1995; 62 FR 5526, Feb. 6, 1997] this chapter. (d) Conditions of use. Preruminating § 520.88f Amoxicillin trihydrate tab- calves including veal calves—(1) Amount. lets. 400 milligrams per 100 pounds of body (a) Specifications. Each tablet con- weight twice daily. tains amoxicillin trihydrate equivalent (2) Indications for use. Treatment of to 50, 100, 200, or 400 milligrams of bacterial enteritis when due to suscep- amoxicillin. tible Escherichia coli in preruminating (b) Sponsors. See Nos. 000856 and calves including veal calves. 051311 in § 510.600(c) of this chapter. (3) Limitations. Administer by drench (c) Conditions of use—(1) Dogs—(i) or by mixing in milk. Treatment should be continued for 48 hours after Amount. 5 milligrams per pound of body all symptoms have subsided but not to weight twice a day. exceed 5 days. For use in (ii) Indications for use. Treatment of preruminating calves including veal bacterial dermatitis due to Staphy- calves only, not for use in other ani- lococcus aureus, Streptococcus spp., mals which are raised for food produc- Staphylococcus spp., and Escherichia tion. Do not slaughter animals during coli; and soft tissue infections (ab- treatment or for 20 days after the lat- scesses, wounds, lacerations) due to S. est treatment. Federal law restricts aureus, Streptococcus spp., E. coli, Pro- this drug to use by or on the order of a teus mirabilis, and Staphylococcus spp. licensed veterinarian. (iii) Limitations. Use for 5 to 7 days or 48 hours after all symptoms have sub- [57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. sided. If no improvement is seen in 5 15, 1992; 58 FR 18304, Apr. 8, 1993, as amended at 60 FR 55658, Nov. 2, 1995; 62 FR 5525, Feb. days, review diagnosis and change ther- 6, 1997] apy. Federal law restricts this drug to use by or on the order of a licensed vet- § 520.88e Amoxicillin trihydrate erinarian. boluses. (2) [Reserved] (a) Specifications. Each bolus contains [57 FR 37320, Aug. 18, 1992, as amended at 62 the equivalent of 400 milligrams of FR 13302, Mar. 20, 1997; 67 FR 67521, Nov. 6, amoxicillin. 2002; 68 FR 54658, Sept. 18, 2003; 68 FR 55824, (b) Sponsor. See No. 000069 in Sept. 29, 2003] § 510.600(c) of this chapter. (c) Related tolerances. See § 556.38 of § 520.88g Amoxicillin trihydrate and this chapter. clavulanate potassium film-coated (d) Conditions of use. Preruminating tablets. calves including veal calves(1) Amount. (a) Specifications. Each tablet con- 400 milligrams per 100 pounds of body tains amoxicillin trihydrate and weight twice daily. clavulanate potassium, equivalent to (2) Indications for use. Treatment of either 50 milligrams of amoxicillin and bacterial enteritis when due to suscep- 12.5 milligrams clavulanic acid, or 100

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milligrams of amoxicillin and 25 milli- tinued and diagnosis reevaluated. Uri- grams clavulanic acid, or 200 milli- nary tract infections may require grams amoxicillin and 50 milligrams treatment for 10 to 14 days or longer. clavulanic acid or 300 milligrams The maximum duration of treatment amoxicillin and 75 milligrams should not exceed 30 days. Safety of use clavulanic acid. in pregnant or breeding animals has (b) Sponsor. See No. 000069 in not been established. Federal law re- § 510.600(c) of this chapter. stricts this drug to use by or on the (c) Conditions of use(1) Dogs—(i) order of a licensed veterinarian. Amount. 6.25 milligrams (equivalent to [57 FR 37320, Aug. 18, 1992, as amended at 60 5 milligrams amoxicillin and 1.25 milli- FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, grams clavulanic acid) per pound of 1998] body weight twice daily. (ii) Indications for use. Treatment of § 520.88h Amoxicillin trihydrate and skin and soft tissue infections such as clavulanate potassium for oral sus- wounds, abscesses, cellulitis, super- pension. ficial/juvenile and deep pyoderma due (a) Specifications. When reconstituted, to susceptible strains of beta- each milliliter contains amoxicillin lactamase (penicillinase) Staphy- trihydrate equivalent to 50 milligrams lococcus aureus, nonbeta-lactamase S. of amoxicillin with clavulanate potas- aureus, Staphylococcus spp., Strepto- sium equivalent to 12.5 milligrams of coccus spp., and Escherichia coli. Treat- clavulanic acid. ment of periodontal infections due to (b) Sponsor. See No. 000069 in susceptible strains of aerobic and an- § 510.600(c) of this chapter. aerobic bacteria. (c) Conditions of use(1) Dogs—(i) (iii) Limitations. Wounds, abscesses, Amount. 6.25 milligrams (equivalent to cellulitis, and superficial/juvenile 5 milligrams amoxicillin and 1.25 milli- pyoderma: Treat for 5 to 7 days or for grams clavulanic acid) per pound of 48 hours after all signs have subsided. body weight twice daily. If no improvement is seen after 5 days (ii) Indications for use. Treatment of of treatment, discontinue therapy and skin and soft tissue infections such as reevaluate diagnosis. Deep pyoderma wounds, abscesses, cellulitis, super- may require treatment for 21 days; do ficial/juvenile and deep pyoderma due not treat for more than 30 days. Not for to susceptible strains of beta- use in dogs maintained for breeding. lactamase (penicillinase) producing Federal law restricts this drug to use Staphylococcus aureus, nonbeta- by or on the order of a licensed veteri- lactamase Staphylococcus aureus, Staph- narian. ylococcus spp., Streptococcus spp., and (2) Cats—(i) Amount. 62.5 milligrams Escherichia coli. Treatment of peri- (1 milliliter) (50 milligrams amoxicillin odontal infections due to susceptible and 12.5 milligrams clavulanic acid) strains of aerobic and anaerobic bac- twice daily. teria. (ii) Indications for use. Treatment of (iii) Limitations. Administer for 5 to 7 skin and soft tissue infections, such as days or 48 hours after all symptoms wounds, abscesses and cellulitis/derma- subsided. Deep pyoderma may require titis due to susceptible strains of beta- 21 days, not to exceed 30 days. If no im- lactamase (penicillinase) producing S. provement is seen in 5 days, dis- aureus, nonbeta-lactamase producing S. continue therapy and reevaluate the aureus, Staphylococcus spp., Strepto- case. Not for use in dogs maintained coccus spp., E. coli, and Pasteurella spp. for breeding. Federal law restricts this Also, treatment of urinary tract infec- drug to use by or on the order of a li- tions (cystitis) due to susceptible censed veterinarian. strains of E. coli. (2) Cats—(i) Amount. 62.5 milligrams (iii) Limitations. Skin and soft tissue (1 milliliter) (50 milligrams of infections: abscesses, cellulitis/derma- amoxicillin and 12.5 milligrams titis should be treated for 5 to 7 days or clavulanic acid) twice daily. for 48 hours after all signs have sub- (ii) Indications for use. Treatment of sided. If no response is seen after 3 days feline skin and soft tissue infections, of treatment, therapy should be discon- such as wounds, abscesses and

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cellulitis/dermatitis due to susceptible this drug to use by or on the order of a strains of beta-lactamase (penicil- licensed veterinarian. linase) producing S. aureus, nonbeta- (2) Cats—(i) Amount. 125 milligrams lactamase S. aureus, Staphylococcus twice daily; in more acute conditions spp., Streptococcus spp., E. coli, three times daily. Pasteurella multocida, and Pasteurella (ii) Indications for use. Treatment of spp. respiratory tract infections (bacterial (iii) Limitations. Administer 48 hours pneumonia) due to alpha and beta he- after all symptoms have subsided. If no molytic streptococci, hemolytic posi- improvement is seen after 3 days of tive staphylococci, E. coli, and Proteus treatment, discontinue therapy and re- spp. In infections associated with ab- evaluate diagnosis. Maximum duration scesses, lacerations, and wounds due to of treatment should not exceed 30 days. Staphylococcus spp. and Streptococcus Not for use in cats maintained for spp. breeding. Federal law restricts this (iii) Limitations. Bacteriologic studies drug to use by or on the order of a li- to determine the causative organisms censed veterinarian. and their susceptibility to ampicillin should be performed. Use of the drug is [57 FR 37320, Aug. 18, 1992, as amended at 60 contraindicated in animals with a his- FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, tory of an allergic reaction to any of 1998] the penicillins. Ampicillin is contra- § 520.90 Ampicillin oral dosage forms. indicated in infections caused by penicillinase-producing organisms. Not for § 520.90a Ampicillin capsules. use in animals which are raised for (a) Specifications. Each capsule con- food production. Federal law restricts tains 125 milligrams or 250 milligrams this drug to use by or on the order of a of ampicillin. licensed veterinarian. (b) Sponsor. See No. 000008 in [57 FR 37321, Aug. 18, 1992] § 510.600(c) of this chapter. (c) Conditions of use(1) Dogs—(i) § 520.90b Ampicillin trihydrate tablets. Amount. 5 to 10 milligrams per pound of (a) Specifications. Each tablet con- body weight, e.g., one 125 mg capsule tains ampicillin trihydrate equivalent per 14 to 25 pounds, given 2 to 4 times to 50 or 100 milligrams of ampicillin. daily; for animals weighing 6 to 14 (b) Sponsor. See No. 000069 in pounds, one capsule twice daily. § 510.600(c) of this chapter. (ii) Indications for use. Treatment of (c) Conditions of use. Dogs(1) Amount. 5 urinary tract infections (cystitis) due milligrams per pound of body weight, to Proteus spp., hemolytic and non- at 8-hour intervals, 1 to 2 hours prior to hemolytic streptococci, beta hemolytic feeding, to be continued 36 to 48 hours streptococci, and Escherichia coli. In after all symptoms have subsided. If no upper respiratory tract infections improvement is seen within 5 days, tracheobronchitis (kennel cough), ton- stop treatment, reevaluate diagnosis, sillitis due to alpha and beta hemolytic and change therapy. streptococci, hemolytic positive (2) Indications for use. Oral treatment staphylococci, E. coli, and Proteus spp. of infections caused by susceptible or- In infections associated with abscesses, ganisms as follows: Upper respiratory lacerations, and wounds due to Staphy- infections, tonsillitis, and bronchitis lococcus spp. and Streptococcus spp. due to Streptococcus spp., Staphylococcus (iii) Limitations. Bacteriologic studies spp., Escherichia coli, Proteus mirabilis, to determine the causative organisms and Pasteurella spp., urinary tract in- and their susceptibility to ampicillin fections (cystitis) due to Streptococcus should be performed. Use of the drug is spp., Staphylococcus spp., E., coli, P. contraindicated in animals with a his- mirabilis, and Enterococcus spp.; gastro- tory of an allergic reaction to any of intestinal infections due to Staphy- the penicillins. Ampicillin is contra- lococcus spp., Streptococcus spp., indicated in infections caused by peni- Enterococcus spp., and E. coli. ; infec- cillinase-producing organisms. Not for tions associated with abscesses, lacera- use in animals which are raised for tions, and wounds caused by Staphy- food production. Federal law restricts lococcus spp., and Streptococcus spp.

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(3) Limitations. Not for use in animals pneumonia); urinary tract infections which have shown hypersensitivity to (cystitis); and generalized infections penicillin or for infections caused by (septicemia) associated with abscesses, penicillinase-producing organisms. Not lacerations, and wounds. for use in animals which are raised for (iii) Limitations. The drug may be food production. Federal law restricts given as an emergency measure; how- this drug to use by or on the order of a ever, in vitro sensitivity tests on sam- licensed veterinarian. ples collected prior to treatment should be made. Ampicillin is contra- [57 FR 37321, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995] indicated for use in infections caused by penicillinase-producing organisms § 520.90c Ampicillin trihydrate cap- and for use in animals known to be al- sules. lergic to any of the penicillins. Not for (a) Specifications. Each capsule con- use in animals raised for food produc- tains ampicillin trihydrate equivalent tion. Federal law restricts this drug to to 125, 250, or 500 milligrams of ampi- use by or on the order of a licensed vet- cillin. erinarian. (b) Sponsor. See No. 055529 in [57 FR 37321, Aug. 18, 1992, as amended at 58 § 510.600(c) of this chapter. FR 61016, Nov. 19, 1993] (c) Conditions of use(1) Dogs—(i) Amount. 5 to 10 milligrams per pound of § 520.90d Ampicillin trihydrate for oral body weight two or three times daily. suspension. In severe or acute conditions, 10 milli- (a) Specifications. When reconstituted grams per pound of body weight, three as directed, each milliliter contains times daily. Administer 1 to 2 hours ampicillin trihydrate equivalent to 25 prior to feeding. milligrams of ampicillin. (ii) Indications for use. Treatment (b) Sponsor. See No. 055529 in against strains of gram-negative and § 510.600(c) of this chapter. gram-positive organisms sensitive to (c) Conditions of use(1) Dogs—(i) ampicillin and associated with res- Amount. 5 to 10 milligrams per pound of piratory tract infections body weight orally, 2 or 3 times daily, (tracheobronchitis and tonsillitis); uri- 1 to 2 hours prior to feeding. In severe nary tract infections (cystitis); bac- or acute conditions, 10 milligrams per terial gastroenteritis; generalized in- pound of body weight 3 times daily. fections (septicemia) associated with (ii) Indications for use. Treatment of abscesses, lacerations, and wounds; and respiratory tract infections bacterial dermatitis. (tracheobronchitis and tonsillitis) due (iii) Limitations. The drug may be to Escherichia coli, Pseudomonas spp., given as an emergency measure; how- Proteus spp., Staphylococcus spp., and ever, in vitro sensitivity tests on sam- Streptococcus spp., urinary tract infec- ples collected prior to treatment tions (cystitis) due to E. coli, Staphy- should be made. Ampicillin is contra- lococcus spp., Streptococcus spp., and indicated for use in infections caused Proteus spp.; bacterial gastroenteritis by penicillinase-producing organisms due to E. coli; generalized infections and for use in animals known to be al- (septicemia) associated with abscesses, lergic to any of the penicillins. Not for lacerations, and wounds, due to Staphy- use in animals raised for food produc- lococcus spp. and Streptococcus spp.; bac- tion. Federal law restricts this drug to terial dermatitis due to Staphylococcus use by or on the order of a licensed vet- spp., Streptococcus spp., Proteus spp., erinarian. and Pseudomonas spp. (2) Cats—(i) Amount. 10 to 30 milli- (iii) Limitations. Duration of treat- grams per pound of body weight or ment is usually 3 to 5 days. Continue three times daily. Administer 1 to 2 treatment 48 hours after the animal’s hours prior to feeding. temperature has returned to normal (ii) Indications for use. Treatment and all other signs of infection have against strains of gram-negative and subsided. If no response is obtained gram-positive organisms sensitive to within 3 to 5 days, reevaluate diagnosis ampicillin and associated with res- and treatment. Appropriate laboratory piratory tract infections (bacterial tests should be conducted, including in

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vitro culturing and susceptibility tests lococcus spp., Streptococcus spp., and on samples collected prior to treat- Salmonella spp. ment. Federal law restricts this drug (3) Limitations. For use in swine only. to use by or on the order of a licensed Not for use in other animals which are veterinarian. raised for food production. Treated (2) Cats—(i) Amount. 10 to 30 milli- swine must not be slaughtered for food grams per pound of body weight orally, during treatment and for 24 hours fol- 2 or 3 times daily, 1 to 2 hours prior to lowing the last treatment. Federal law feeding. restricts this drug to use by or on the (ii) Indications for use. Treatment of order of a licensed veterinarian. respiratory tract infections (bacterial pneumonia) due to Staphylococcus spp., [57 FR 37322, Aug. 18, 1992, as amended at 58 Streptococcus spp., E. coli, and Proteus FR 61016, Nov. 19, 1993] spp.; urinary tract infections (cystitis) due to E. coli, Staphylococcus spp., § 520.90f Ampicillin trihydrate boluses. Streptococcus spp., Proteus spp., and (a) Specifications. Each bolus contains Corynebacterium spp.; generalized infec- ampicillin trihydrate equivalent to 400 tions (septicemia) associated with ab- milligrams of ampicillin. scesses, lacerations, and wounds, due (b) Sponsor. See No. 055529 in to Staphylococcus spp., Streptococcus § 510.600(c) of this chapter for use as in spp., Bacillus spp., and Pasteurella spp. paragraph (d)(1), 000069 for use as in (iii) Limitations. Duration of treat- paragraph (d)(2). ment is usually 3 to 5 days. Continue (c) Related tolerances. See § 556.40 of treatment 48 hours after the animal’s this chapter. temperature has returned to normal (d) Conditions of use. Nonruminating and all other signs of infection have subsided. If no response is obtained calves(1) Amount. 5 milligrams per within 3 to 5 days, reevaluate diagnosis pound of body weight twice daily for up and treatment. Appropriate laboratory to 5 days. tests should be conducted, including in (i) Indications for use. Oral treatment vitro culturing and susceptibility tests of colibacillosis caused by Escherichia on samples collected prior to treat- coli, bacterial enteritis caused by Sal- ment. Federal law restricts this drug monella spp., and bacterial pneumonia to use by or on the order of a licensed caused by Pasteurella spp. veterinarian. (ii) Limitations. Treated calves must not be slaughtered for food during [57 FR 37321, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993] treatment and for 15 days after the last treatment. Not for use in other ani- § 520.90e Ampicillin trihydrate soluble mals raised for food production. Fed- powder. eral law restricts this drug to use by or (a) Specifications. Each gram contains on the order of a licensed veterinarian. ampicillin trihydrate equivalent to 88.2 (2) Amount. 5 milligrams per pound of milligrams of ampicillin. body weight twice daily not to exceed 4 (b) Sponsor. See No. 055529 in days. § 510.600(c) of this chapter. (i) Indications for use. Oral treatment (c) Related tolerances. See § 556.40 of of bacterial enteritis (colibacillosis) this chapter. caused by E. coli. (d) Conditions of use. Swine(1) Amount. (ii) Limitations. Treated calves must 5 milligrams of ampicillin per pound of not be slaughtered for food during body weight twice daily, orally by ga- treatment and for 7 days after the last vage or in drinking water for up to 5 treatment. Not for use in other ani- days. mals raised for food production. Fed- (2) Indications for use. Oral treatment eral law restricts this drug to use by or of porcine colibacillosis (Escherichia on the order of a licensed veterinarian. coli) and salmonellosis (Salmonella spp.) infections in swine up to 75 pounds of [57 FR 37322, Aug. 18, 1992, as amended at 58 body weight, and bacterial pneumonia FR 61016, Nov. 19, 1993; 60 FR 55659, Nov. 2, caused by Pasteurella multocida, Staphy- 1995]

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§ 520.100 Amprolium. (ii) Limitations. Withdraw 24 hours be- (a) Specifications(1) Each milliliter of fore slaughter. A withdrawal period has solution contains 96 milligrams (mg) not been established for this product in amprolium (9.6 percent solution). preruminating calves. Do not use in (2) Each gram of powder contains 200 calves to be processed for veal. Use as mg amprolium (20 percent). the sole source of amprolium. (3) Each ounce (28.4 grams) of crum- [71 FR 56346, Sept. 27, 2006, as amended at 72 bles contains 355 mg amprolium (1.25 FR 60551, Oct. 25, 2007; 73 FR 45611, Aug. 6, percent). 2008; 73 FR 70276, Nov. 20, 2008; 74 FR 10484, (b) Sponsors. See sponsors in 510.600(c) Mar. 11, 2009; 76 FR 38554, July 1, 2011; 76 FR of this chapter. 40808, July 12, 2011; 78 FR 23, Jan. 2, 2013; 78 (1) No. 016592 for use of products de- FR 17596, Mar. 22, 2013; 78 FR 57058, Sept. 17, scribed in paragraph (a) of this section 2013] as in paragraph (d) of this section. (2) No. 066104 for use of product de- § 520.110 Apramycin sulfate soluble scribed in paragraph (a)(1) of this sec- powder. tion as in paragraph (d) of this section. (a) Specifications. A water soluble (3) No. 000859 for use of product de- powder used to make a medicated scribed in paragraph (a)(1) of this sec- drinking water containing apramycin tion as in paragraph (d) of this section. sulfate equivalent to 0.375 gram of (4) No. 061623 for use of products described in paragraphs (a)(1) and (a)(2) of apramycin activity per gallon of drink- this section as in paragraph (d) of this ing water. section. (b) Sponsor. See No. 000986 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 chick- this chapter. ens, turkeys, and laying hens. It is used (d) Conditions of use. (1) In swine for in drinking water as follows: control of porcine colibacillosis (i) Amount. Administer at the 0.012 (weanling pig scours) caused by strains percent level in drinking water as soon of E. coli sensitive to apramycin. as coccidiosis is diagnosed and con- (2) It is administered for 7 days in tinue for 3 to 5 days (in severe out- drinking water at the rate of 12.5 milli- breaks, give amprolium at the 0.024 grams of apramycin per kilogram (5.7 percent level); continue with 0.006 per- milligrams per pound) of body weight cent amprolium-medicated water for per day. Swine will normally consume an additional 1 to 2 weeks. 1 gallon per day of medicated water (ii)Indications for use. For the treat- containing 375 milligrams of ment of coccidiosis. (iii) Limitations. Use as the sole apramycin for each 66 pounds of body source of amprolium. weight. Water consumption should be (2) Calves. Administer crumbles top- monitored to determine that the re- dressed on or thoroughly mixed in the quired amount of apramycin is being daily feed ration; administer con- consumed. The drug concentration centrate solution or soluble powder as should be adjusted according to water a drench or in drinking water as fol- consumption which varies depending lows: on ambient temperature, humidity, (i) Indications for use and amounts— and other factors. (A) As an aid in the prevention of coc- (3) Prepare fresh medicated water cidiosis caused by Eimeria bovis and E. daily. zurnii, administer 5 mg per kilogram (4) Do not slaughter treated swine for (mg/kg) body weight for 21 days during 28 days following treatment periods of exposure or when experience indicates that coccidiosis is likely to [47 FR 15771, Apr. 13, 1982, as amended at 49 be a hazard. FR 19642, May 9, 1984; 53 FR 37753, Sept. 28, (B) As an aid in the treatment of coc- 1988] cidiosis caused by E. bovis and E. zurnii, administer 10 mg/kg body weight for 5 days.

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§ 520.154 Bacitracin oral dosage forms. (ii) Indications for use. For prevention of ulcerative enteritis due to Clos- § 520.154a Bacitracin methylene disa- tridium colinum susceptible to baci- licylate. tracin methylene disalicylate. (a) Specifications. Each pound of solu- (iii) Limitations. Prepare fresh soluble powder contains the equivalent of tion daily. Use as sole source of drink- 50 grams of bacitracin activity for use ing water. as in paragraph (d)(1) or (d)(2) of this [57 FR 37322, Aug. 18, 1992; 57 FR 42623, Sept. section, or the equivalent of 200 grams 15, 1992, as amended at 63 FR 38474, July 17, of bacitracin activity for use as in 1998; 64 FR 13068, Mar. 17, 1999; 76 FR 53050, paragraph (d) of this section. Aug. 25, 2011] (b) Sponsor. See No. 046573 in § 510.600(c) of this chapter. § 520.154b Bacitracin methylene disa- (c) Related tolerances. See § 556.70 of licylate and streptomycin sulfate this chapter. powder. (d) Conditions of use(1) Growing tur- (a) Specifications. Each gram of pow- keys—(i) Amount. 400 milligrams (mg) der contains 200 units bacitracin meth- per gallon (gal) in drinking water. ylene disalicylate and streptomycin (ii) Indications for use. Aid in the con- sulfate equivalent to 20 milligrams of trol of transmissible enteritis com- streptomycin. plicated by organisms susceptible to (b) Sponsor. See No. 046573 in bacitracin methylene disalicylate. § 510.600(c) of this chapter. (iii) Limitations. Prepare a fresh solu- (c) Conditions of use in dogs(1) Amount. tion daily. Administer 1 level teaspoonful per 10 (2) Broiler and replacement chickens— pounds of body weight three times (i) Amount. 100 mg per gal in drinking daily, mixed in a small quantity of liq- water. uid or feed. (A) Indications for use. Aid in the pre- (2) Indications for use. For the treat- vention of necrotic enteritis caused by ment of bacterial enteritis caused by Clostridium perfringens susceptible to pathogens susceptible to bacitracin and bacitracin methylene disalicylate. streptomycin such as Escherichia coli, (B) Limitations. Prepare a fresh solu- Proteus spp., Staphylococcus spp., and tion daily. Streptococcus spp., and for the sympto- (ii) Amount. 200 to 400 mg per gal in matic treatment of associated diar- drinking water. Administer continu- rhea. ously 5 to 7 days or as long as clinical (3) Limitations. Federal law restricts signs persist, then reduce to prevention this drug to use by or on the order of a levels (100 mg/gal). licensed veterinarian. (A) Indications for use. Treatment of necrotic enteritis caused by C. [71 FR 17702, Apr. 7, 2006] perfringens susceptible to bacitracin methylene disalicylate. § 520.154c Bacitracin zinc soluble powder. (B) Limitations. Prepare a fresh solution daily. (a) Specifications. Each pound con- (3) Swine—(i) Amount. 1 gram per gal- tains the equivalent of not less than 5 lon in drinking water. grams of bacitracin. (ii) Indications for use. Treatment of (b) Sponsor. See No. 053501 in swine dysentery associated with § 510.600(c) of this chapter. Treponema hyodysenteriae. Administer (c) Related tolerances. See § 556.70 of continuously for 7 days or until signs this chapter. of dysentery disappear. (d) Conditions of use—(1) Broiler chick- (iii) Limitations. Prepare a fresh solu- ens—(i) Amount. 100 milligrams per gal- tion daily. Treatment not to exceed 14 lon in drinking water. days. If symptoms persist after 4 to 5 (A) Indications for use. Prevention of days consult a veterinarian. Not to be necrotic enteritis caused by Clostridium given to swine that weigh more than perfringens susceptible to bacitracin 250 pounds. zinc. (4) Growing quail—(i) Amount. 400 mg (B) Limitations. Prepare a fresh solu- per gal in drinking water. tion daily.

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(ii) Amount. 200 to 400 milligrams per § 520.246 Butorphanol tartrate tablets. gallon in drinking water. (a) Specifications. Each tablet con- (A) Indications for use. Control of ne- tains 1, 5, or 10 milligrams of crotic enteritis caused by Clostridium butorphanol base activity as perfringens susceptible to bacitracin butorphanol tartrate. zinc. (b) Sponsor. See No. 000856 in (B) Limitations. Prepare a fresh solu- § 510.600(c) of this chapter. tion daily. (c) Conditions of use. The drug is used (2) Growing quail—(i) Amount. 500 mil- for the treatment of dogs as follows: ligrams per gallon in drinking water (1) Amount. 0.25 milligram of for 5 days followed by 165 milligrams butorphanol base activity per pound of per gallon in drinking water for 10 body weight. days. (2) Indications for use. For the relief of (ii) Indications for use. Control of ul- chronic nonproductive cough associ- cerative enteritis caused by Clostridium ated with tracheo-bronchitis, tra- spp. susceptible to bacitracin zinc. cheitis, tonsillitis, laryngitis, and (iii) Limitations. Prepare a fresh solu- pharyngitis associated with inflam- tion daily. matory conditions of the upper res- [57 FR 37322, Aug. 18, 1992, as amended at 67 piratory tract. FR 78355, Dec. 24, 2002] (3) Limitations. For oral use in dogs only. Repeat at intervals of 6 to 12 § 520.222 Bunamidine hydrochloride. hours as required. If necessary, in- (a) Chemical name. N,N-Dibutyl-4- crease dose to a maximum of 0.5 milli- (hexyloxy)-1-naphthamidine hydro- gram per pound of body weight. Treat- chloride. ment should not normally be required (b) Specifications. The drug is an oral for longer than 7 days. Federal law re- tablet containing 100, 200, or 400 milli- stricts this drug to use by or on the grams of bunamidine hydrochloride. order of a licensed veterinarian. (c) Sponsor. See No. 000061 in [47 FR 14702, Apr. 6, 1982, as amended at 53 § 510.600(c) of this chapter. FR 27851, July 25, 1988] (d) Conditions of use. (1) The drug is intended for oral administration to § 520.260 n-Butyl chloride. dogs for the treatment of the tape- (a)(1) Specifications. n-Butyl chloride worms Dipylidium caninum, Taenia capsules, veterinary contain 272 milli- pisiformis, and Echinococcus granulosus, grams or 816 milligrams of n-butyl and to cats for the treatment of the chloride in each capsule. tapeworms Dipylidium caninum and (2) Sponsor. See No. 021091 in Taenia taeniaeformis. § 510.600(c) of this chapter. (2) It is administered to cats and dogs (3) Conditions of use. (i) It is used for at the rate of 25 to 50 milligrams per the removal of ascarids (Toxocara canis kilogram of body weight. The drug and Toxascaris leonina) and hookworms should be given on an empty stomach (Ancylostoma caninum, Ancylostoma and food should not be given for 3 braziliense, and Uncinaria stenocephala) hours following treatment. from dogs and of the ascarid (Toxocara (3) Tablets should not be crushed, cati) and hookworm (Ancylostoma mixed with food, or dissolved in liquid. tubaeforme) from cats. Repeat treatments should not be given (ii)(a) Animals should not be fed for within 14 days. The drug should not be 18 to 24 hours before being given the given to male dogs within 28 days prior drug. Puppies and kittens should be to their use for breeding. Do not ad- wormed at 6 weeks of age. However, if minister to dogs or cats having known heavily infested, they may be wormed heart conditions. at 4 or 5 weeks of age. Administration (4) For use only by or on the order of of the drug should be followed in 1⁄2 to a licensed veterinarian. 1 hour with a teaspoonful to a table- [40 FR 13838, Mar. 27, 1975, as amended at 42 spoonful of milk of magnesia or 1 or 2 FR 13018, Mar. 8, 1977; 46 FR 48642, Oct. 2, milk of magnesia tablets. Normal ra- 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, tions may be resumed 4 to 8 hours after Nov. 19, 1997] treatment. Puppies and kittens should

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be given a repeat treatment in a week braziliense, and Uncinaria stenocephala) or 10 days. After that they should be from dogs. 1 treated every 2 months (or as symp- (ii)(a) Dogs should not be fed for 18 to toms reappear) until a year old. When 24 hours before being given the drug. the puppy or kitten is a year old, one Administration of the drug should be treatment every 3 to 6 months is suffi- followed in 1⁄2 to 1 hour with a mild ca- cient. thartic. Normal feeding may be re- (b) For dogs or cats that have been sumed 4 to 8 hours after treatment. wormed regularly, treatment every 3 to Animals subject to reinfection may be 6 months will be sufficient. If a dog or retreated in 2 weeks. 1 cat has not been wormed previously (b) The drug is administered orally to and has the symptoms of large dogs. Capsules containing 221 milli- roundworms a dose should be given and grams of n-butyl chloride are adminis- repeated in 10 days. Removal of tered to dogs weighing under 5 pounds hookworms may require 3 or 4 doses at at a dosage level of 1 capsule per 11⁄4 10-day intervals. pound of body weight. Capsules con- (c) Puppies, dogs, cats, or kittens taining 442 milligrams of n-butyl chlo- weighing 1 to 3 pounds should be given ride are administered to dogs weighing 2 capsules per dose which contain 272 under 5 pounds at a dosage level of 1 milligrams of n-butyl chloride each. capsule per 21⁄2 pounds body weight. Such animals weighing 4 to 5 pounds Capsules containing 884 milligrams of should be given 3 such capsules. Ani- n-butyl chloride are administered to mals weighing 6 to 7 pounds should be dogs as follows: Weighing under 5 given 4 such capsules and animals pounds, 1 capsule; weighing 5 to 10 weighing 8 to 9 pounds should be given pounds, 2 capsules; weighing 10 to 20 5 such capsules. Animals weighing 10 to pounds, 3 capsules; weighing 20 to 40 20 pounds should be given 3 capsules pounds, 4 capsules; over 40 pounds, 5 which contain 816 milligrams of n- capsules. Capsules containing 1,768 mil- butyl chloride each, animals weighing ligrams of n-butyl chloride are admin- 20 to 40 pounds should be given 4 such istered at a dosage level of 1 capsule capsules and animals weighing over 40 per dog weighing 5 to 10 pounds. Cap- pounds should be given 5 such capsules sules containing 4.42 grams of n-butyl with the maximum dosage being 5 cap- chloride are administered at a dosage sules, each of which contains 816 milli- level of 1 capsule per dog weighing 40 1 grams of n-butyl chloride. pounds or over. (iii) A veterinarian should be con- (iii) A veterinarian should be consulted before using in severely debili- sulted before using in severely debilitated dogs. 1 tated dogs or cats and also prior to repeated use in cases which present signs [40 FR 13838, Mar. 27, 1975, as amended at 40 of persistent parasitism. FR 39858, Aug. 29, 1975; 44 FR 10059, Feb. 16, (b)(1) Specifications. n-Butyl chloride 1979; 54 FR 38515, Sept. 19, 1989; 55 FR 24556, capsules contain 221, 442, 884, or 1,768 June 18, 1990; 64 FR 15684, Apr. 1, 1999; 70 FR 50182, Aug. 26, 2005; 78 FR 14669, Mar. 7, 2013] milligrams or 4.42 grams of n-butyl chloride in each capsule. 1 EDITORIAL NOTE: At 78 FR 14669, Mar. 7, (2) Sponsors. See No. 023851 in 2013, § 520.260 was amended by adding para- § 510.600(c) of this chapter for 221, 442, graphs (b)(1) through (3); however, the amendment could not be incorporated be- 884, or 1,768 milligram or 4.42 gram cap- cause (b)(1) through (3) already exist. sules; No. 038782 for 884 or 1,768 milligram or 4.42 gram capsules; and No. § 520.300 Cambendazole oral dosage 000069 for 221 milligram capsules. forms. (3) Conditions of use. (i) It is used for the removal of ascarids (Toxocara canis § 520.300a Cambendazole suspension. and Toxascaris leonina) and hookworms (a) Specifications. Each fluid ounce (Ancylostoma caninum, Ancylostoma contains 0.9 gram of cambendazole. (b) Sponsor. No. 050604 in § 510.600(c) of 1 These conditions are NAS/NRC reviewed this chapter. and deemed effective. Applications for these (c) Conditions of use. (1) It is used in uses need not include effectiveness data as horses for the control of large specified by § 514.111 of this chapter. strongyles (Strongylus vulgaris, S.

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edentatus, S. equinus); small strongyles (5) Caution: Do not administer to (Trichonema, Poteriostomum, pregnant mares during first 3 months Cylicobrachytus, Craterostomum, of pregnancy. Oesophagodontus); roundworms (6) Consult your veterinarian for as- (Parascaris); pinworms. (Oxyuris); and sistance in the diagnosis, treatment, threadworms (Strongyloides). and control of parasitism. (2) It is administered by stomach tube or as a drench at a dose of 0.9 [41 FR 1276, Jan. 7, 1976, as amended at 42 FR 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997] gram of cambendazole per 100 pounds of body weight (20 milligrams per kilo- § 520.300c Cambendazole paste. gram). (3) For animals maintained on prem- (a) Specifications. The drug is a paste ises where reinfection is likely to containing 45 percent cambendazole. occur, re-treatments may be necessary. (b) Sponsor. No. 050604 in § 510.600(c) of For most effective results, re-treat in 6 this chapter. to 8 weeks. (c) Conditions of use. (1) It is used in (4) Not for use in horses intended for horses for the control of large food. strongyles (Strongylus vulgaris, S. (5) Caution: Do not administer to edentatus, S. equinus); small strongyles pregnant mares during first 3 months (Trichonema, Poteriostomum, of pregnancy. Cylicobrachytus, Craterostomum, (6) Federal law restricts this drug to Oesophagodontus); roundworms use by or on the order of a licensed vet- (Parascaris); pinworms (Oxyuris); and erinarian. threadworms (Strongyloides). (2) Administer 20 milligrams [40 FR 13838, Mar. 27, 1975. Redesignated at 41 cambendazole per kilogram body FR 1276, Jan. 7, 1976, and amended at 42 FR weight (5 grams per 550 pounds (250 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997] kilograms)) by depositing the paste on the back of the tongue using a dosing § 520.300b Cambendazole pellets. gun. (a) Specifications. The drug is in feed (3) For animals maintained on prem- pellets containing 5.3 percent ises where reinfection is likely to cambendazole. occur, re-treatments may be necessary. (b) Sponsor. No. 050604 in § 510.600(c) of For most effective results, re-treat in 6 this chapter. to 8 weeks. (c) Conditions of use. (1) It is used in (4) Not for use in horses intended for horses for the control of large food. strongyles (Strongylus vulgaris, S. (5) Caution: Do not administer to edentatus, S. equinus); small strongyles pregnant mares during first 3 months (Trichonema, Poteriostomum, of pregnancy. Cylicobrachytus, Craterostomum, (6) Consult your veterinarian for as- Oesophagodontus); roundworms sistance in the diagnosis, treatment, (Parascaris); pinworms (Oxyuris); and and control of parasitism. threadworms (Strongyloides). (2) Administer 20 milligrams [41 FR 1276, Jan. 7, 1976, as amended at 42 FR cambendazole per kilogram body 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997] weight (6 ounces per 1,000 pounds) by mixing with normal grain ration given § 520.309 Carprofen. at one feeding. Doses for individual (a) Specifications. (1) Each caplet con- horses should be mixed and fed sepa- tains 25, 75, or 100 milligrams (mg) rately to assure that each horse will carprofen. consume the correct amount. (2) Each chewable tablet contains 25, (3) For animals maintained on prem- 75, or 100 mg carprofen. ises where reinfection is likely to (b) Sponsors. See sponsors in occur, re-treatments may be necessary. § 510.600(c) of this chapter for uses as in For most effective results, re-treat in 6 paragraph (d) of this section. to 8 weeks. (1) No. 000069 for use of products de- (4) Not for use in horses intended for scribed in paragraph (a) of this section food. as in paragraph (d) of this section.

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(2) Nos. 000115, 000859, 055529, and (2) Indications for use. For treating 062250 for use of product described in trichomoniasis (canker) in ornamental paragraph (a)(1) as in paragraph (d) of and homing pigeons. this section. (3) Limitations. Not for use in pigeons (c) [Reserved] intended for human food. Consult your (d) Conditions of use in dogs(1) Amount. veterinarian for assistance in the diag- 2 mg per pound (/lb) of body weight nosis, treatment, and control of para- once daily or 1 mg/lb twice daily. For sitism or when severely ill birds do not the control of postoperative pain, ad- respond to treatment. minister approximately 2 hours before the procedure. [54 FR 32336, Aug. 7, 1989] (2) Indications for use. For the relief of § 520.314 Cefadroxil. pain and inflammation associated with osteoarthritis and for the control of (a) Specifications.(1) Each tablet con- postoperative pain associated with soft tains 50, 100, or 200 milligrams (mg) or tissue and orthopedic surgeries. 1 gram of cefadroxil. (3) Limitations. Federal Law restricts (2) Each milliliter of suspension con- this drug to use by or on the order of a stituted from powder contains 50 mg of licensed veterinarian. cefadroxil. (b) Sponsor. See No. 000010 in [61 FR 66581, Dec. 18, 1996, as amended at 64 § 510.600(c) of this chapter. FR 32181, June 16, 1999; 66 FR 63165, Dec. 5, (c) Conditions of use in dogs and cats— 2001; 67 FR 6866, Feb. 14, 2002; 67 FR 65038, Oct. 23, 2002; 67 FR 65697, Oct. 28, 2002; 70 FR (1) Amount—(i) Dogs. Administer 10 mg 30626, May 27, 2005; 71 FR 51995, Sept. 1, 2006; per pound (/lb) body weight twice daily 72 FR 68478, Dec. 5, 2007; 74 FR 21768, May 11, orally. 2009; 78 FR 52853, Aug. 27, 2013; 78 FR 66264, (ii) Cats. Administer 10 mg/lb body Nov. 5, 2013] weight once daily orally. (2) Indications for use—(i) Dogs. For § 520.310 Caramiphen the treatment of skin and soft tissue ethanedisulfonate and ammonium chloride tablets. infections including cellulitis, pyoderma, dermatitis, wound infec- (a) Specifications. Each tablet con- tions, and abscesses due to susceptible tains 10 milligrams of 5st caramiphen strains of Staphylococcus aureus. For ethanedisulfonate and 80 milligrams of the treatment of genitourinary tract 1 ammonium chloride. infections (cystitis) due to susceptible (b) Sponsor. See No. 000856 in strains of Escherichia coli, Proteus § 510.600(c) of this chapter. mirabilis, and S. aureus. (c) Conditions of use in dogs(1) Amount. (ii) Cats. For the treatment of skin One tablet per 15 to 30 pounds of body and soft tissue infections including ab- 1 weight every 4 to 6 hours. scesses, wound infections, cellulitis, (2) Indications for use. For relief of and dermatitis caused by susceptible cough.1 strains of Pasteurella multocida, S. [43 FR 55385, Nov. 28, 1978] aureus, Staphylococcus epidermidis, and Streptococcus spp. § 520.312 Carnidazole tablets. (3) Limitations. Federal law restricts (a) Specifications. Each tablet con- this drug to use by or on the order of a tains 10 milligrams of carnidazole. licensed veterinarian. (b) Sponsor. See 053923 in § 510.600(c) of [75 FR 10165, Mar. 5, 2010] this chapter. (c) Conditions of use(1) Amount. Adult § 520.370 Cefpodoxime tablets. pigeons: 1 tablet (10 milligrams); newly (a) Specifications. Each tablet con- weaned pigeons: 1⁄2 tablet (5 milligrams). tains cefpodoxime proxetil equivalent to 100 or 200 milligrams (mg) cefpodoxime. 1 These conditions are NAS/NRC reviewed (b) Sponsors. See Nos. 000009 and and deemed effective. Applications for these uses need not include effectiveness data as 026637 in § 510.600(c) of this chapter. specified by § 514.111 of this chapter, but may (c) Conditions of use in dogs(1) Amount. require bioequivalency and safety informa- 5 to 10 mg per kilogram (2.3 to 4.5 mg tion. per pound) body weight daily for 5 to 7

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days, or for 2 to 3 days beyond the ces- (c) Conditions of use in dogs(1) Amount. sation of clinical signs, up to a max- Administer 25 mg per pound of body imum of 28 days. weight by mouth every 6 hours. (2) Indications for use. For the treat- (2) Indications for use—(i) For the ment of skin infections (wounds and treatment of bacterial pulmonary in- abscesses) caused by susceptible strains fections, bacterial infections of the uri- of Staphylococcus intermedius, S. aureus, nary tract, bacterial enteritis, and bac- Streptococcus canis (group G, -hemo- terial infections associated with canine lytic), Escherichia coli, Pasteurella distemper caused by susceptible orga- multocida, and Proteus mirabilis. nisms. (3) Limitations. Federal law restricts (ii) For the treatment of bacterial this drug to use by or on the order of a gastroenteritis associated with bac- licensed veterinarian. terial diarrhea, bacterial pulmonary [69 FR 52815, Aug. 30, 2004, as amended at 78 infections, and bacterial infections of FR 5714, Jan. 28, 2013] 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. [77 FR 4896, Feb. 1, 2012, as amended at 78 FR (c) Conditions of use—(1) Dogs—(i) 21059, Apr. 9, 2013] Amount. Administer 22 mg per kilogram of body weight twice daily for 28 § 520.390b Chloramphenicol capsules. days. (a) Specifications. Each capsule con- (ii) Indications for use. For the treat- tains 50, 100, 250, or 500 milligrams (mg) ment of secondary superficial bacterial chloramphenicol. pyoderma in dogs caused by susceptible (b) Sponsors. See Nos. 000069 and strains of Staphylococcus 050057 in § 510.600(c) of this chapter for pseudintermedius. use as in paragraph (d) of this section. (iii) Limitations. Federal law restricts this drug to use by or on the order of a (c) Special considerations. Federal law licensed veterinarian. prohibits the extralabel use of this (2) [Reserved] product in food-producing animals. (d) Conditions of use in dogs(1) Amount. [77 FR 47512, Aug. 9, 2012] 25 mg per pound of body weight every 6 hours. § 520.390 Chloramphenicol oral dosage (2) Indications for use. For treatment forms. of bacterial pulmonary infections, bac- § 520.390a Chloramphenicol tablets. terial infections of the urinary tract, bacterial enteritis, and bacterial infec- (a) Specifications. Each tablet con- tions associated with canine distemper tains 50, 100, 250, or 500 milligrams caused by susceptible organisms. (mg); 1 or 2.5 grams (g) of chloramphen- (3) Limitations. Federal law restricts icol. this drug to use by or on the order of a (b) Sponsors. See § 510.600(c) of this licensed veterinarian. chapter: (1) For use as in paragraphs (c)(1), [70 FR 75398, Dec. 20, 2005, as amended at 73 (c)(2)(i), and (c)(3) of this section: FR 18442, Apr. 4, 2008; 75 FR 55676, Sept. 14, (i) No. 054628 for 100-, 250-, and 500-mg; 2010] and 1- and 2.5-g tablets; (ii) No. 000856 for 100-, 250-, and 500- § 520.390c Chloramphenicol palmitate mg tablets; oral suspension. (iii) No. 000069 for 250-mg tablets. (a) Specifications. Each milliliter con- (2) For use as in paragraphs (c)(1), tains chloramphenicol palmitate equiv- (c)(2)(ii), and (c)(3) of this section: alent to 30 milligrams of chloramphen- (i) No. 061623 for 50-, 100-, 250-, and icol. 500-mg; and 1-g tablets; (b) Sponsor. See No. 000856 in (ii) [Reserved] § 510.600(c) of this chapter.

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(c) Conditions of use. Dogs(1) Amount. (b) Animals should be regularly and 25 milligrams per pound of body weight carefully observed for early signs of every 6 hours. If no response is ob- fluid and electrolyte imbalance. Take tained in 3 to 5 days, discontinue use appropriate countermeasures if this and reevaluate diagnosis. should occur. In some dogs, (2) Indications for use. Treatment of hypochloremic alkalosis may occur bacterial pulmonary infections, infec- (that is, excretion of chloride in relations of the urinary tract, enteritis, tion to sodium is excessive; the plasma and infections associated with canine bicarbonate level increases and distemper that are caused by orga- alkalosis results). Federal law restricts nisms susceptible to chloramphenicol. this drug to use by or on the order of a 1 (3) Limitations. Not for use in animals licensed veterinarian. that are raised for food production. (b)(1) Specifications. Each bolus con- Must not be used in meat-, egg-, or tains 2 grams of chlorothiazide. milk-producing animals. The length of (2) Sponsor. See No. 000006 in time that residues persist in milk or § 510.600(c) of this chapter. tissues has not been determined. Fed- (3) Conditions of use—(i) Amount. 2 eral law restricts this drug to use by or grams once or twice daily for 3 or 4 1 on the order of a licensed veterinarian. days. (ii) Indications for use. For use in cat- [57 FR 37323, Aug. 18, 1992; 57 FR 42623, Sept. tle as an aid in reduction of 15, 1992] postparturient udder edema. 1 (iii) Limitations. Animals should be § 520.420 Chlorothiazide tablets and regularly and carefully observed for boluses. early signs of fluid and electrolyte im- (a)(1) Specifications. Each tablet con- balance. Take appropriate counter- tains 0.25 gram of chlorothiazide. measures if this should occur. Milk (2) Sponsor. See No. 050604 in taken from dairy animals during treat- § 510.600(c) of this chapter. ment and for 72 hours (six milkings) (3) Conditions of use—(i) Amount. after latest treatment must not be Usual dosage is 5 to 10 milligrams per used for food. Federal law restricts this pound of body weight two or three drug to use by or on the order of a li- times daily. 1 censed veterinarian. 1 (ii) Indications for use. For use in dogs [43 FR 39085, Sept. 1, 1978, as amended at 62 for treatment of congestive heart fail- FR 63270, Nov. 28, 1997] ure and renal edema. 1 (iii) Limitations. (a) Dosage must be § 520.434 Chlorphenesin carbamate adjusted to meet the changing needs of tablets. the individual animal. In mild and re- (a) Specifications. Each tablet con- sponsive cases, it is suggested that a tains 400 milligrams of chlorphenesin dose of 5 milligrams per pound of body carbamate. weight be administered two or three (b) Sponsor. See No. 000009 in times daily. In moderately edematous § 510.600(c) of this chapter. and moderately responsive animals, a (c) Conditions of use in dogs(1) dose of 7.5 to 10 milligrams per pound Amount. 50 milligrams per pound of of body weight may be administered body weight on first day; 25 milligrams three times daily. Severe conditions per pound of body weight each fol- may require higher doses. Certain ani- lowing day. Divide total daily dose into mals may respond adequately to inter- 2 or 3 equal doses—administer at 12- or mittent therapy; in these cases, the 8-hour intervals. drug may be administered either every (2) Indications for use. For use as an other day or for 3 to 5 days each week. adjunct to therapy of acute inflammatory and traumatic conditions of skeletal muscles. The drug provides re- 1 These conditions are NAS/NRC reviewed lief of the signs of discomfort associ- and deemed effective. Applications for these uses need not include effectiveness data as ated with myositis, muscle sprains, specified by § 514.111 of this chapter, but may traumatic injuries, stifle injuries—es- require bioequivalency and safety informa- pecially when administered before or tion. after surgery—and invertebral disc

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syndrome (can be used concurrently chlortetracycline; administer for not with adrenal corticosteroids). more than 5 days. (3) Limitations. Not recommended for (B) [Reserved] pregnant animals or those with a (ii) [Reserved] known hepatic dysfunction. Periodic (2) Use as chlortetracycline hydro- liver function studies are recommended chloride in a drench or drinking water for animals on prolonged treatment. If as follows: no response is evident within 5 days of (i) Calves—(A) Amount. Ten milli- the beginning of treatment, the diag- grams per pound of body weight daily nosis should be redetermined and ap- in divided doses. propriate therapy instituted. Not rec- (1) Control and treatment of bac- ommended for use with general anes- terial enteritis (scours) caused by E. thetics other than the barbiturates. coli and bacterial pneumonia (shipping Federal law restricts this drug to use fever) associated with Pasteurella spp., by or on the order of a licensed veteri- A. pleuropneumoniae (Hemophilus spp.), narian. and Klebsiella spp. (2) Limitations. Prepare fresh solution [44 FR 16009, Mar. 16, 1979] 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. (b) Sponsors. See sponsors in (B) [Reserved] § 510.600(c) of this chapter for use as in (ii) [Reserved] paragraph (d) of this section. (3) [Reserved] (1) No. 048164 for use as in paragraph (4) The following uses of chlortetra- (d) of this section. cycline hydrochloride or chlortetra- (2) Nos. 046573 and 000010 for use as in cycline bisulfate in drinking water or paragraph (d) of this section. drench were reviewed by the National (3) No. 054628 for use as in paragraphs Academy of Sciences/National Re- (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) search Council (NAS/NRC) and found through (d)(4)(iv) of this section. effective: (d)(4)(ii) through (iv) of this section. (i) Chickens—(A) Amount. 200 to 400 (4) Nos. 012286 and 076475 for use as in milligrams per gallon. paragraphs (d)(4)(i)(A), (d)(4)(i)(B), (1) Indications for use. Control of in- (d)(4)(ii), and (d)(4)(iii) of this section. fectious synovitis caused by Myco- (c) Related tolerances. See § 556.150 of plasma synoviae. this chapter. (2) Limitations. Prepare fresh solution (d) Conditions of use. (1) Use as chlor- daily; as sole source of chlortetra- tetracycline hydrochloride in drinking cycline; do not use for more than 14 water as follows: days; do not slaughter animals for food (i) Swine—(A) Amount. Ten milli- within 24 hours of treatment; do not grams per pound of body weight daily use in laying chickens. in divided doses. (B) Amount. 400 to 800 milligrams per (1) Indications for use. Control and gallon. treatment of bacterial enteritis (1) Indications for use. Control of (scours) caused by Escherichia coli and chronic respiratory disease and air-sac bacterial pneumonia associated with infections caused by M. gallisepticum Pasteurella spp., Actinobacillus and E. coli. pleuropneumoniae (Hemophilus spp.), and (2) Limitations. Prepare fresh solution Klebsiella spp. daily; as sole source of chlortetra- (2) Limitations. Prepare a fresh solu- cycline; do not use for more than 14 tion twice daily; as sole source of days; do not slaughter animals for food

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within 24 hours of treatment; do not pleuropneumoniae (Hemophilus spp.), and use in laying chickens. Klebsiella spp. (C) Amount. One thousand milligrams (C) Limitations. Prepare fresh solution per gallon. daily; use as a drench; as sole source of (1) Indications for use. Control of mor- chlortetracycline; do not use for more tality due to fowl cholera caused by than 5 days; do not slaughter animals Pasteurella multocida susceptible to for food within 24 hours of treatment; chlortetracycline. do not use in lactating cattle; do not $(2) Limitations. See paragraph administer this product with milk or (d)(4)(i)(A)(2) of this section. milk replacers; administer 1 hour be- (ii) Growing turkeys—(A) Amount. 400 fore or 2 hours after feeding milk or milligrams per gallon. milk replacers; a withdrawal period has (1) Indications for use. Control of in- not been established in preruminating fectious synovitis caused by M. calves; do not use in calves to be proc- synoviae. essed for veal. (2) Limitations. Prepare fresh solution (5) Use in a drench or drinking water daily; as sole source of chlortetra- as follows: cycline; do not use for more than 14 (i) Chickens—(A) Amount. 200 to 400 days; do not slaughter animals for food mg/gal, for 7 to 14 days. within 24 hours of treatment. (1) Indications for use. Control of in- (B) Amount. 25 milligrams per pound fectious synovitis caused by M. of body weight daily. synoviae susceptible to chlortetra- (1) Indications for use. Control of com- cycline. plicating bacterial organisms associ- (2) Limitations. Prepare fresh solution ated with bluecomb (transmissible en- daily; use as the sole source of chlor- teritis, coronaviral enteritis). tetracycline; do not use for more than (2) Limitations. Prepare fresh solution 14 consecutive days; do not use in lay- daily; as sole source of chlortetra- ing chickens; do not administer to cycline; do not use for more than 14 chickens within 24 hours of slaughter. days; do not slaughter animals for food (B) Amount. 400 to 800 mg/gal, for 7 to within 24 hours of treatment. 14 days. (iii) Swine—(A) Amount. 10 milligrams (1) Indications for use. Control of per pound body weight daily in divided chronic respiratory disease (CRD) and doses. air-sac infections caused by M. (B) Indications for use. Control and gallisepticum and E. coli susceptible to treatment of bacterial enteritis chlortetracycline. (scours) caused by E. coli and Sal- (2) Limitations. As in paragraph monella spp. and bacterial pneumonia (d)(5)(i)(A)(2) of this section. associated with Pasteurella spp., (C) Amount. One thousand mg/gal, for Actinobacillus pleuropneumoniae 7 to 14 days. (Hemophilus spp.), and Klebsiella spp. (1) Indications for use. Control of mor- (C) Limitations. Prepare fresh solution tality due to fowl cholera caused by daily; as sole source of chlortetra- Pasteurella multocida susceptible to cycline; do not use for more than 5 chlortetracycline. days. For Nos. 000010 and 021930, do not (2) Limitations. As in paragraph slaughter animals for food within 5 (d)(5)(i)(A)(2) of this section. days of treatment. For No. 000010, do (ii) Growing Turkeys—(A) Amount. 400 not slaughter animals for food within mg/gal, for 7 to 14 days. 24 hours of treatment. (1) Indications for use. Control of in- (iv) Calves, beef cattle, and nonlac- fectious synovitis caused by Myco- tating dairy cattle—(A) Amount. 10 milli- plasma synoviae susceptible to chlor- grams per pound daily in divided doses. tetracycline. (B) Indications for use. Control and (2) Limitations. Prepare fresh solution treatment of bacterial enteritis daily; use as the sole source of chlor- (scours) caused by E. coli and Sal- tetracycline; do not use for more than monella spp. and bacterial pneumonia 14 consecutive days; do not administer (shipping fever complex) associated to growing turkeys within 24 hours of with Pasteurella spp., A. slaughter.

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(B) Amount. 25 mg/lb body weight (b) Sponsor. See No. 054628 in daily, for 7 to 14 days. § 510.600(c) of this chapter. (1) Indications for use. Control of com- (c) Related tolerances. See § 556.150 of plicating bacterial organisms associ- this chapter. ated with bluecomb (transmissible en- (d) Conditions of use in calves(1) teritis, coronaviral enteritis) suscep- Amount. One 250 milligram bolus per 50 tible to chlortetracycline. pounds of body weight twice a day for (2) Limitations. As in paragraph 3 to 5 days. (d)(5)(ii)(A)(2) of this section. (iii) Swine—(A) Amount. 10 mg/lb body (i) Indications for use. Treatment of weight daily, for 3 to 5 days. bacterial enteritis (scours) caused by (B) Indications for use. Control and Escherichia coli and bacterial pneu- treatment of bacterial enteritis monia associated with Pasteurella spp., (scours) caused by E. coli and Sal- Klesbsiella spp., and Hemophilus spp. monella spp., and bacterial pneumonia (ii) Limitations. Administer bolus di- associated with Pasteurella spp., A. rectly by mouth or crush and dissolve pleuropneumoniae, and Klebsiella spp. in milk or water for drenching or buck- susceptible to chlortetracycline. et feeding; if no improvement is noted (C) Limitations. Prepare fresh solution after 3 days of treatment, consult a daily; use as the sole source of chlor- veterinarian; do not use for more than tetracycline; do not use for more than 5 days; do not administer within 24 5 days; do not administer to swine hours of slaughter. within 24 hours of slaughter. (2) Amount. One 25 milligram tablet (iv) Calves, beef cattle, and nonlac- for each 5 pounds of body weight every —(A) 10 mg/lb tating dairy cattle Amount. 12 hours daily for 3 to 5 days. body weight daily in divided doses, for (i) Indications for use. Control and 3 to 5 days. (B) Indications for use. Control and treatment of bacterial enteritis treatment of bacterial enteritis (scours) caused by E. coli and Sal- (scours) caused by Escherichia coli and monella spp. and bacterial pneumonia Salmonella spp., and bacterial pneu- associated with Pasteurella spp., monia associated with Pasteurella spp., Hemophilus spp., and Klebsiella spp., sus- Histophilus spp., and Klebsiella spp. susceptible to chlortetracycline. ceptible to chlortetracycline. (ii) Limitations. Administer tablet di- (C) Limitations. Prepare fresh solution rectly by mouth or crush and dissolve daily; use as a drench; use as the sole in water for drenching; if no improve- source of chlortetracycline; do not use ment is noted after 3 days of treat- for more than 5 days; do not administer ment, consult a veterinarian; do not to cattle within 24 hours of slaughter; use for more than 5 days; when feeding do not use in lactating dairy cattle; do milk or milk replacer, administration 1 not administer this product with milk hour before or 2 hours after feeding; do or milk replacers; administer 1 hour not administer within 24 hours of before or 2 hours after feeding milk or slaughter. milk replacers; a withdrawal period has (3) Amount. One 500 milligram bolus not been established in preruminating per 100 pounds of body weight twice a calves; do not use in calves to be proc- day for 3 to 5 days. essed for veal. (i) Indications for use. Treatment of [57 FR 37324, Aug. 18, 1992] bacterial enteritis (scours) caused by E. EDITORIAL NOTE: For FEDERAL REGISTER ci- coli and Salmonella spp., and bacterial tations affecting § 520.441, see the List of CFR pneumonia associated with Pasteurella Sections Affected, which appears in the spp., Hemophilus spp., and Klebsiella Finding Aids section of the printed volume spp., susceptible to chlortetracycline. and at www.fdsys.gov. (ii) Limitations. Administer directly § 520.443 Chlortetracycline tablets and by mouth or crush and dissolve in boluses. water for drenching; if no improvement (a) Specifications. Each tablet/bolus is noted after 3 days of treatment, con- contains 25, 250, or 500 milligrams (mg) sult a veterinarian; do not use for more chlortetracycline hydrochloride.

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than 5 days; do not administer within (3) No. 043806 for use of tablets de- 24 hours of slaughter. scribed in paragraph (a)(3) of this section. [57 FR 37325, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002. Redesignated and (c) Conditions of use in dogs(1) Amount. amended at 76 FR 49649, Aug. 11, 2011; 78 FR Wounds, abscesses, and dental infec- 21059, Apr. 9, 2013] tions: 2.5 to 15 mg per pound (/lb) body weight every 12 hours for a maximum § 520.445 Chlortetracycline and of 28 days. Osteomyelitis: 5.0 to 15 mg/ sulfamethazine powder. lb body weight every 12 hours for a (a) Specifications. Each pound of solu- minimum of 28 days. ble powder contains chlortetracycline (2) Indications for use. For the treat- bisulfate equivalent to 102.4 grams (g) ment of skin infections (wounds and of chlortetracycline hydrochloride and abscesses) due to susceptible strains of sulfamethazine bisulfate equivalent to coagulase-positive staphylococci 102.4 g of sulfamethazine. (Staphylococcus aureus or S. (b) Sponsor. See No. 000010 in intermedius), deep wounds and abscesses § 510.600(c) of this chapter. due to susceptible strains of Bacteroides (c) Related tolerances. See §§ 556.150 fragilis, Prevotella melaninogenicus, and 556.670 of this chapter. Fusobacterium necrophorum, and Clos- (d) Conditions of use in swine. Admin- tridium perfringens, dental infections ister in drinking water as follows: due to susceptible strains of S. aureus, (1) Amount. 250 milligrams (mg) of B. fragilis, P. melaninogenicus, F. chlortetracycline and 250 mg of necrophorum, and C. perfringens, and os- sulfamethazine per gallon. teomyelitis due to susceptible strains (2) Indications for use. For the preven- of S. aureus, B. fragilis, P. tion and treatment of bacterial enter- melaninogenicus, F. necrophorum, and C. itis; as an aid in the reduction of the perfringens. incidence of cervical abscesses; and as (3) Limitations. Federal law restricts an aid in the maintenance of weight this drug to use by or on the order of a gains in the presence of bacterial en- licensed veterinarian. teritis and atrophic rhinitis. [67 FR 54954, Aug. 27, 2002, as amended at 68 (3) Limitations. Use as the sole source FR 55824, Sept. 29, 2003; 69 FR 32273, June 9, of chlortetracycline and sulfonamide. 2004; 71 FR 39204, July 12, 2006; 73 FR 4077, Not to be used for more than 28 con- Jan. 24, 2008; 78 FR 17596, Mar. 22, 2013] secutive days. Withdraw 15 days before § 520.447 Clindamycin solution. slaughter. (a) Specifications. Each milliliter of [76 FR 49649, Aug. 11, 2011] solution contains the equivalent of 25 milligrams (mg) clindamycin as the § 520.446 Clindamycin capsules and hydrochloride salt. tablets. (b) Sponsors. See Nos. 000009, 000859, (a) Specifications(1) Each capsule con- 051311, 058829, and 061623 in § 510.600(c) of tains the equivalent of 25, 75, 150, or 300 this chapter. milligrams (mg) clindamycin as the (c) Special considerations. Federal law hydrochloride salt. restricts this drug to use by or on the (2) Each tablet contains the equiva- order of a licensed veterinarian. lent of 25, 75, or 150 mg clindamycin as (d) Conditions of use(1) Dogs—(i) the hydrochloride salt. Amount. Wounds, abscesses, and dental (3) Each capsule contains the equiva- infections: 2.5 to 15 mg per pound (/lb) lent of 25, 75, or 150 mg clindamycin as body weight every 12 hours for a max- the hydrochloride salt. imum of 28 days. Osteomyelitis: 5.0 to (b) Sponsors. See sponsors in 15 mg/lb body weight every 12 hours for § 510.600(c) of this chapter as follows: a minimum of 28 days. (1) Nos. 000009 and 000859 for use of (ii) Indications for use. For the treat- capsules described in paragraph (a)(1) ment of skin infections (wounds and of this section. abscesses) due to susceptible strains of (2) No. 051311 for use of tablets de- coagulase-positive staphylococci scribed in paragraph (a)(2) of this sec- (Staphylococcus aureus or S. tion. intermedius), deep wounds and abscesses

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due to susceptible strains of Bacteroides curs in chronic obstructive pulmonary fragilis, Prevotella melaninogenicus, disease (COPD). Fusobacterium necrophorum, and Clos- (iii) Limitations. Treat at effective tridium perfringens; dental infections dose for 30 days. At the end of the 30- due to susceptible strains of S. aureus, day treatment period, drug should be B. fragilis, P. melaninogenicus, F. withdrawn. If signs return, the 30-day necrophorum, and C. perfringens; and os- treatment period may be repeated. If teomyelitis due to susceptible strains repeating treatment, the step-wise dos- of S. aureus, B. fragilis, P. age schedule should be repeated. The melaninogenicus, F. necrophorum, and C. effect of this drug on breeding stallions perfringens. and brood mares has not been deter- (2) Cats—(i) Amount. 5.0 to 15.0 mg/lb mined. Treatment starting with dos- body weight every 24 hours for a max- ages higher than the initial dose is not imum of 14 days. recommended. Federal law prohibits (ii) Indications for use. For the treat- the extralabel use of this drug in food ment of skin infections (wounds and animals. Federal law restricts this abscesses) due to susceptible strains of drug to use by or on the order of a li- Staphylococcus aureus, S. intermedius, censed veterinarian. Streptococcus spp.; deep wounds and ab- (2) [Reserved] scesses due to susceptible strains of [63 FR 41419, Aug. 4, 1998] Clostridium perfringens and Bacteroides fragilis; and dental infections due to § 520.455 Clomipramine tablets. susceptible strains of S. aureus, S. intermedius, Streptococcus spp., C. (a) Specifications. Each tablet con- perfringens, and B. fragilis. tains 5, 20, 40, or 80 milligrams (mg) clomipramine hydrochloride. [67 FR 54954, Aug. 27, 2002, as amended at 67 (b) Sponsor. See No. 058198 in FR 78684, Dec. 26, 2002; 68 FR 55824, Sept. 29, § 510.600(c) of this chapter. 2003; 69 FR 31734, June 7, 2004; 71 FR 39543, (c) Conditions of use(1) Amount. 2 to 4 July 13, 2006; 72 FR 19796, Apr. 20, 2007; 78 FR 17596, Mar. 22, 2013; 78 FR 30197, May 22, 2013] milligrams of clomipramine hydrochloride per kilogram (0.9 to 1.8 milli- § 520.452 Clenbuterol syrup. grams per pound) of body weight per day, administered as a single daily dose (a) Specifications. Each milliliter con- or divided twice daily. tains 72.5 micrograms of clenbuterol (2) Indications for use. For use as part hydrochloride. of a comprehensive behavioral manage- (b) Sponsor. See 000010 in § 510.600(c) of ment program to treat separation anx- this chapter. iety in dogs greater than 6 months of (c) [Reserved] age. (d) Conditions of use(1) Horses—(i) (3) Limitations. Federal law restricts Amount. Administer orally twice a day this drug to use by or on the order of a (b.i.d.). Initial dose is 0.5 milliliter per licensed veterinarian. 100 pounds body weight (0.8 micrograms per kilogram) for 3 days (6 treatments). [64 FR 1762, Jan. 12, 1999, as amended at 72 If no improvement, administer 1 milli- FR 262, Jan. 4, 2007] liter per 100 pounds (1.6 micrograms per § 520.462 Clorsulon drench. kilogram) for 3 days (6 treatments). If no improvement, administer 1.5 milli- (a) Specifications. The drug is a sus- liters per 100 pounds (2.4 micrograms pension containing 8.5 percent per kilogram) for 3 days (6 treatments). clorsulon (85 milligrams per milliliter). If no improvement, administer 2.0 mil- (b) Sponsor. See No. 050604 in liliters per 100 pounds (3.2 micrograms § 510.600(c) of this chapter. per kilogram) for 3 days (6 treatments). (c) Conditions of use. Cattle(1) Amount. If no improvement, horse is non- One-quarter fluid ounce per 200 pounds responder to clenbuterol and treatment of body weight (7 milligrams per kilo- should be discontinued. gram or 3.2 milligrams per pound of (ii) Indications for use. Indicated for body weight). the management of horses affected (2) Indications for use. For the treat- with airway obstruction, such as oc- ment of immature and adult liver fluke

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(Fasciola hepatica) infestations in cat- least 6 months of age and weighing at tle. least 3 pounds. (3) Limitations. Using dose syringe, (iii) Limitations. Federal law restricts deposit drench over back of tongue. Do this drug to use by or on the order of a not treat cattle within 8 days of licensed veterinarian. slaughter. Because a withdrawal time 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 053501 in § 510.600 of this chapter. § 520.522 Cyclosporine. (c) Special considerations. Cythioate is (a) Specifications(1) Each cyclosporine a cholinesterase inhibitor. Do not use capsule, USP (MODIFIED) contains 10, this product in animals simultaneously 25, 50, or 100 milligrams (mg) with or within a few days before or cyclosporine. after treatment with or exposure to (2) Each milliliter of cyclosporine cholinesterase-inhibiting drugs, insec- oral solution, USP (MODIFIED) con- ticides, pesticides, or chemicals. tains 100 mg cyclosporine. (d) Conditions of use(1) Amount. 15 mil- (b) Sponsor. See No. 058198 in ligrams cythioate per 10 pounds of body § 510.600(c) of this chapter. weight every third day or twice a week. (c) [Reserved] (2) Indications for use. Dogs, for con- (d) Conditions of use(1) Dogs. Use cap- trol of fleas. sules described in paragraph (a)(1) of (3) Limitations. For oral use in dogs this section as follow: only. Do not use in greyhounds or in (i) Amount. Administer 5 mg per kilo- animals that are pregnant, sick, under gram (mg/kg) of body weight given stress, or recovering from surgery. Fed- orally as a single daily dose for 30 days. eral law restricts this drug to use by or Following this initial daily treatment on the order of a licensed veterinarian. period, the dosage may be tapered by decreasing the frequency of adminis- [49 FR 5614, Feb. 14, 1984, as amended at 67 tration to every other day or two times FR 78355, Dec. 24, 2002] a week, until a minimum frequency is reached which will maintain the de- § 520.531 Cythioate tablets. sired therapeutic effect. (a) [Reserved] (ii) Indications for use. For the control (b) Sponsors. See No. 000859 in of atopic dermatitis in dogs weighing § 510.600(c) of this chapter for use of 30- at least 4 pounds. and 90-milligram (mg) tablets and see (iii) Limitations. Federal law restricts No. 053501 in § 510.600(c) of this chapter this drug to use by or on the order of a for use of 30-mg tablet. licensed veterinarian. (2) Cats. Use the solution described in (c) Special considerations. Cythioate is paragraph (a)(2) of this section as fol- a cholinesterase inhibitor. Do not use low: this product in animals simultaneously (i) Amount. Administer 7 mg/kg of with or within a few days before or body weight orally as a single daily after treatment with or exposure to dose for a minimum of 4 to 6 weeks or cholinesterase-inhibiting drugs, insec- until resolution of clinical signs. Fol- ticides, pesticides, or chemicals. lowing this initial daily treatment pe- (d) Conditions of use(1) Amount. 30 mil- riod, the dosage may be tapered by de- ligrams cythioate per 20 pounds of body creasing the frequency of administra- weight every third day or twice a week. tion to every other day or twice weekly (2) Indications for use. Dogs, for con- to maintain the desired therapeutic ef- trol of fleas. fect. (3) Limitations. For oral use in dogs (ii) Indications for use. For the control only. Do not use in greyhounds or in of feline allergic dermatitis in cats at animals that are pregnant, sick, under

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stress, or recovering from surgery. 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. [49 FR 5615, Feb. 14, 1984, as amended at 59 [67 FR 68760, Nov. 13, 2002, as amended at 68 FR 26942, May 25, 1994; 67 FR 78355, Dec. 24, FR 18882, Apr. 17, 2003; 72 FR 37437, July 10, 2002] 2007; 73 FR 33692, June 13, 2008; 77 FR 3928, Jan. 26, 2012] § 520.534 Decoquinate. (a) Specifications. The drug is a pow- § 520.540 Dexamethasone oral dosage der containing 0.8 percent decoquinate. forms. (b) Sponsor. See No. 046573 in § 510.600(c) of this chapter. § 520.540a Dexamethasone powder. (c) Related tolerances. See § 556.170 of (a) Specifications. Dexamethasone this chapter. powder is packaged in packets con- (d) Conditions of use. Calves(1) Amount. taining 10 milligrams of dexametha- Feed 22.7 milligrams per 100 pounds of sone. body weight (0.5 milligram per kilo- (b) Sponsor. See No. 000061 in gram) per day. § 510.600(c) of this chapter. (2) Indications for use. For the preven- (c) Conditions of use. (1) Dexametha- tion of coccidiosis in ruminating and sone powder is indicated in cases where nonruminating calves, including veal cattle and horses require additional calves, caused by Eimeria bovis and E. steroid therapy following its parenteral zuernii. administration. The drug is used as (3) Limitations. Feed in whole milk at supportive therapy for management or the rate of 22.7 milligrams per 100 inflammatory conditions such as acute pounds body weight daily (0.5 milli- arthritic lameness, and for various gram per kilogram) for at least 28 days. stress conditions where corticosteroids [64 FR 10103, Mar. 2, 1999, as amended at 64 are required while the animal is being FR 30386, June 8, 1999] treated for a specific condition. (2) The drug is administered at a dos- § 520.538 Deracoxib. age level of 5 to 10 milligrams per ani- (a) Specifications. Each tablet con- mal the first day then 5 milligrams per tains 12, 25, 50, 75, or 100 milligrams day as required by drench or by sprin- (mg) deracoxib. kling on a small amount of feed. (b) Sponsor. See No. 058198 in (3) Clinical and experimental data § 510.600(c) of this chapter. have demonstrated that corticosteroids (c) [Reserved] administered orally or parenterally to (d) Conditions of use in dogs—(1) animals may induce the first stage of Amount. Administer orally as needed, parturition when administered during as a single daily dose based on body the last trimester of pregnancy and weight: may precipitate premature parturition (i) 1 to 2 mg/kilogram (kg) (0.45 to followed by dystocia, fetal death, re- 0.91 mg/pound (lb)), for use as in para- tained placenta, and metritis. graph (d)(2)(i) of this section. (4) Federal law restricts this drug to (ii) 1 to 2 mg/kg (0.45 to 0.91 mg/lb) for use by or on the order of a licensed vet- 3 days, for use as in paragraph (d)(2)(ii) erinarian. A withdrawal period has not of this section. been established for this product in (iii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for preruminating calves. Do not use in up to 7 days, for use as in paragraph calves to be processed for veal. (d)(2)(iii) of this section. (2) Indications for use. (i) For the con- [40 FR 13838, Mar. 27, 1975; 41 FR 9149, Mar. 3, trol of pain and inflammation associ- 1976; 52 FR 7832, Mar. 13, 1987; 70 FR 16934, ated with osteoarthritis. Apr. 4, 2005] (ii) For the control of postoperative pain and inflammation associated with § 520.540b Dexamethasone tablets and dental surgery. boluses. (iii) For the control of postoperative (a)(1) Specifications. Each bolus is pain and inflammation associated with half-scored and contains 10 milligrams orthopedic surgery. of dexamethasone.

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(2) Sponsor. See No. 000061 in that corticosteriods administered oral- § 510.600(c) of this chapter. ly or by injection to animals may in- (3) Conditions of use. (i) Dexametha- duce the first stage of parturition when sone bolus is indicated in cases where administered during the last trimester cattle and horses require additional of pregnancy; and they may precipitate steroid therapy following its parenteral premature parturition followed by administration. The drug may be used dystocia, fetal death, retained pla- as supportive therapy for management centa, and metritis. of inflammatory conditions such as (b) Do not use in viral infections. acute arthritic lamenesses, and for var- Anti-inflammatory action of ious stress conditions where corticosteroids may mask signs of in- corticosteroids are required while the fections. Do not use in animals with animal is being treated for a specific tuberculosis, chronic nephritis, condition. cushingoid syndrome, or peptic ulcers, (ii) Administered orally, 5 to 10 milli- except for emergency therapy.1 grams for the first day, then 5 milli- (c) Federal law restricts this drug to grams per day as required. use by or on the order of a licensed vet- (iii) Do not use in viral infections erinarian.1 during the viremic stage. With bacterial infections, appropriate anti- [40 FR 26273, June 23, 1975, as amended at 44 bacterial therapy should be used. FR 7130, Feb. 6, 1979; 50 FR 49372, Dec. 2, 1985; 52 FR 7832, Mar. 13, 1987; 55 FR 8461, Mar. 8, (iv) Do not use in animals with 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. chronic nephritis and hypercorticalism 31, 2003; 70 FR 16934, Apr. 4, 2005] (cushingoid syndrome), except for emergency therapy. § 520.540c Dexamethasone chewable (v) Clinical and experimental data tablets. have demonstrated that corticosteroids (a) Specifications. Each half-scored administered orally or by injection to tablet contains 0.25 milligram of dexa- animals may induce the first stage of methasone.1 parturition when administered during (b) Sponsor. See No. 000069 in the last trimester of pregnancy and § 510.600(c) of this chapter. may precipitate premature parturition (c) Conditions of use(1) Amount. 0.25 to followed by dystocia, fetal death, re- 1.25 milligrams per day.1 tained placenta, and metritis. (2) Indications for use. Supportive (vi) Federal law restricts this drug to therapy in nonspecific dermatosis and use by or on the order of a licensed vet- inflammatory conditions in dogs.1 erinarian. A withdrawal period has not (3) Limitations. (i) Administer by free- been established for this product in choice feeding or crumble over food. preruminating calves. Do not use in Administer 0.25 to 1.25 milligrams daily calves to be processed for veal. in single or two divided doses until re- (b)(1) Specifications. Each tablet con- sponse is noted or 7 days have elapsed. tains 0.25 milligram of dexametha- When response is attained, dosage sone.1 (2) Sponsors. See Nos. 000061 and 061623 should be gradually reduced by 0.125 in § 510.600(c) of this chapter. milligram per day until maintenance (3) Conditions of use—(i) Amount. level is achieved. Dogs: Administer orally at 0.25 to 1.25 (ii) Clinical and experimental data milligrams per day for up to 7 days. have demonstrated that corticosteriods Cats: 0.125 to 0.5 milligram per day for administered orally or parenterally to up to 7 days.1 animals may induce the first stage of (ii) Indications for use. In treatment parturition when administered during of dogs and cats as an anti-inflam- the last trimester of pregnancy; and matory agent.1 they may precipitate premature partu- (iii) Limitations. (a) Clinical and ex- rition followed by dystocia, fetal death, perimental data have demonstrated retained placenta, and metritis. (iii) Do not use in viral infections. 1 These conditions are NAS/NRC reviewed Anti-inflammatory action of and deemed effective. Applications for these corticosteriods may mask signs of in- uses need not include effectiveness data as fection. Do not use in animals with tu- specified by § 514.111 of this chapter. berculosis, chronic nephritis,

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cushingoid syndrome, or peptic ulcers, period without the addition of milk or except for emergency therapy.1 milk replacer. (iv) Federal law restricts this drug to [48 FR 38606, Aug. 25, 1983, as amended at 56 use by or on the order of a licensed vet- FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, erinarian. 1995; 76 FR 17336, Mar. 29, 2011] [44 FR 7130, Feb. 6, 1979, as amended at 56 FR § 520.563 Diatrizoate meglumine and 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995] diatrizoate sodium oral solution. (a) Specifications. Diatrizoate § 520.550 Glucose/glycine/electrolyte. meglumine oral solution is a water (a) Specifications. The product is dis- soluble radiopaque medium containing tributed in packets each of which con- 66 percent diatrizoate meglumine and tains the following ingredients: Sodium 10 percent diatrizoate sodium. chloride 8.82 grams, potassium phos- (b) Sponsor. See No. 053501 in phate 4.20 grams, citric acid anhydrous § 510.600(c) of this chapter. 0.5 gram, potassium citrate 0.12 gram, (c) Conditions of use. (1) It is indicated aminoacetic acid (glycine) 6.36 grams, for radiography of the gastrointestinal and glucose 44.0 grams. tract in dogs and cats. (b) Sponsor. See No. 000069 in (2) It is administered orally at a dosage level of 0.5 to 1.0 milliliter per § 510.600(c) of this chapter. pound of body weight by gavage or (c) Conditions of use. (1) Glucose/gly- stomach tube. It is administered rec- cine/electrolyte is indicated for use in tally at a dosage level of 0.5 to 1.0 mil- the control of dehydration associated liliter per pound of body weight diluted with diarrhea (scours) in calves. It is with 1 part of the drug to 5 parts of used as an early treatment at the first water. signs of scouring. It may also be used (3) Federal law restricts this drug to as followup treatment following intra- use by or on the order of a licensed vet- venous fluid therapy. erinarian. (2) Dissolve each packet in two [44 FR 12993, Mar. 9, 1979, as amended at 50 quarts of warm water and administer FR 41489, Oct. 11, 1985] to each calf as follows: (i) Scouring and/or dehydrated calves. § 520.580 Dichlorophene and toluene. Feed 2 quarts of solution, twice daily (a) Specifications. Each capsule con- for 2 days (four feedings). No milk or tains 50 milligrams (mg) of milk replacer should be fed during this dichlorophene and 60 mg of toluene, or period. For the next four feedings (days multiples thereof. 3 and 4), use 1 quart of solution to- (b) Sponsors. See sponsors in gether with 1 quart of milk replacer. § 510.600(c) of this chapter for use as in Thereafter, feed as normal. paragraph (c) of this section: (ii) Newly purchased calves. Feed 2 (1) Nos. 017135, 023851, 051311, and quarts of solution instead of milk as 058670 for use only as a single dose. (2) Nos. 000061 and 054628 for use in a the first feed upon arrival. For the next single dose or divided-dosage regimen. scheduled feeding, use 1 quart of solu- (c) Required statement. Consult your tion mixed together with 1 quart of veterinarian for assistance in the diag- milk or milk replacer. Thereafter, feed nosis, treatment, and control of para- as normal. sitism, and before administering to (3) The product should not be used in weak or debilitated animals. animals with severe dehydration (1) Amount. Administer as follows: (down, comatose, or in a state of (i) Single dose: Administer 100 mg of shock). Such animals need intravenous dicholorophene and 120 mg of toluene therapy. A veterinarian should be con- per pound of body weight. sulted in severely scouring calves. The (ii) Divided dose: Administer 100 mg product is not nutritionally complete if of dichlorophene and 120 mg of toluene administered by itself for long periods per 5 pounds of body weight (20 and 24 of time. It should not be administered mg per pound) daily for 6 days. beyond the recommended treatment (2) Indications for use. For the removal of ascarids (Toxocara canis and

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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. Pounds of Repeat treatment in 2 to 4 weeks in Pounds of mixed feed Number of animals subject to reinfection. feed to be to be admin- pigs to be Weight of ani- mixed with istered to treated per mal in pounds each 0.08 [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 Adult Gilts, § 520.581 Dichlorophene tablets. 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 (c) Required statement. Consult your few days before or after treatment with veterinarian for assistance in the diag- or exposure to cholinesterase inhib- nosis, treatment, and control of para- iting drugs, pesticides, or chemicals. sitism, and before administering to The preparation should be mixed thor- weak or debilitated animals. oughly with the feed on a clean, imper- (d) Conditions of use. Dogs(1) Amount. vious surface. Do not allow swine ac- Single dose of 1 tablet (1 gram of cess to feed other than that containing dichlorophene) for each 10 pounds of the preparation until treatment is body weight. complete. Do not treat pigs with signs (2) Indications for use. It is used as an of scours until these signs subside or aid in the removal of tapeworms are alleviated by proper medication. (Taenia pisiformis and Dipylidium Resume normal feeding schedule after- caninum). wards. Swine may be retreated in 4 to (3) Limitations. Withhold solid foods 5 weeks. (f) Conditions of use in dogs. (1) For re- and milk for at least 12 hours prior to moval of Toxocara canis and Toxascaris medication and for 4 hours afterward. leonina (roundworms), Ancylostoma [45 FR 10333, Feb. 15, 1980] caninum and Uncinaria stenocephala (hookworms), and Trichuris vulpis § 520.600 Dichlorvos. (whipworm) residing in the lumen of (a) Chemical name. 2,2-Dichlorvinyl the gastrointestinal tract. dimethyl phosphate. (2) The drug is in capsule form for di- (b) [Reserved] rect administration and in pellet form (c) Sponsor. See No. 054628 in for administration in about one-third § 510.600(c) of this chapter. of the regular canned dog food ration (d) Related tolerances. See § 556.180 of or in ground meat. Dogs may be treat- this chapter. ed with any combination of capsules (e) Conditions of use in swine. (1) It is and/or pellets so that the animal re- recommended for the removal and con- ceives a single dose equaling 12 to 15 trol of sexually mature (adult), sexu- milligrams of the active ingredient per ally immature and/or 4th stage larvae pound of body weight. One-half of the of the whipworm (Trichuris suis), nod- single recommended dosage may be ular worms (Oesophagostomum spp.), given, and the other half may be ad- large round-worm (Ascaris suum), and ministered 8 to 24 hours later. This the mature thick stomach worm split dosage schedule should be used in (Ascarops strongylina) occurring in the animals which are very old, heavily

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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. esterase-inhibiting drugs, pesticides, or (5) Do not use in animals other than chemicals. horses, ponies, and mules. Do not use (7) Federal law restricts this drug to in horses, ponies, and mules intended use by or on the order of a licensed vet- for food purposes. Do not allow fowl ac- erinarian. cess to feed containing this preparation (g) Conditions of use in horses when ad- or to fecal excrement from treated ani- ministered in grain. (1) It is rec- mals. ommended for the removal and control (h) Conditions of use in horses when of bots (Gastrophilus intestinalis, G. na- administered orally by syringe. (1) It is salis), large strongyles (Strongylus recommended for the removal and con- vulgaris, S. equinus, S. edentatus), small trol of first, second, and third instar strongyles (of the genera bots (Gastrophilus intestinalis and G. na- Cyathostomum, Cylicocercus, salis), sexually mature and sexually im- Cylicocyclus, Cylicodontophorus, mature (4th stage) ascarids (Parascaris Triodontophorus, Poteriostomum, equorum) in horses and foals. Gyalocephalus), pinworms (Oxyuris (2) The product is in the form of a gel equi), and large roundworm (Parascaris which is administered directly from a equorum) in horses including ponies and syringe onto the horse’s tongue. The mules. Not for use in foals (sucklings product is administered at a dosage and young weanlings). level of 20 milligrams of dichlorvos per (2) For a satisfactory diagnosis, a mi- kilogram of body weight for the re- croscopic fecal examination should be moval of bots and ascarids. The same performed by a veterinarian or a diag- dosage level is repeated every 21 to 28 nostic laboratory prior to worming. days for the control of bots and (3) It is administered in the grain ascarids. For the control of bots only, portion of the ration at a dosage of 14.2 the repeat dosage is 10 milligrams per milligrams to 18.5 milligrams per kilogram of body weight every 21 to 28 pound of body weight as a single dose. days during bot fly season. It may be administered at one-half of (3) Do not use this product in animals the single recommended dosage and re- simultaneously or within a few days peated 8 to 12 hours later in the treat- before or after treatment with or expo- ment of very aged, emaciated or debili- sure to cholinesterase-inhibiting drugs, tated subjects or those reluctant to pesticides or chemicals. Do not admin- consume medicated feed. In suspected ister in conjunction with or within 1 cases of severe ascarid infection suffi- week of administration of muscle-re- cient to cause concern over mechanical laxant drugs, phenothiazine derived

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tranquilizers, or central nervous sys- (b) Sponsor. See No. 000061 in tem depressants. § 510.600(c) of this chapter. (4) Do not use in horses which are (c) Conditions of use in horses(1) severly debilitated or suffering from di- Amount. Administer 1 milligram (mg) arrhea or severe constipation, infec- per kilogram (0.45 mg per pound) of tious disease, toxemia, or colic. Do not body weight in the daily grain ration administer to horses affected with for 28 days. chronic alveolar emphysema (heaves) (2) Indications for use. For the treat- or other respiratory conditions. ment of equine protozoal (5) Do not use in horses intended for myeloencephalitis (EPM) caused by food purposes. Sarcocystis neurona. (6) Federal law restricts this drug to (3) Limitations. Do not use in horses use by or on the order of a licensed vet- intended for human consumption. Fed- erinarian. eral law restricts this drug to use by or (i) Conditions of use in dogs, cats, pup- on the order of a licensed veterinarian. pies, and kittens. (1) Each tablet con- [72 FR 20943, Apr. 27, 2007] tains 2, 5, 10, or 20 milligrams of dichlorvos. § 520.608 Dicloxacillin sodium (2) It is administered orally at 5 mil- monohydrate capsules. ligrams of dichlorvos per pound of body (a) Specifications. Each capsule con- weight. tains dicloxacillin sodium (3) Dogs and puppies: Removal and monohydrate equivalent to 50, 100, 200, control of intestinal roundworms or 500 milligrams of dicloxacillin. (Toxocara canis and Toxascaris leonina) (b) Sponsor. See No. 000856 in § 510.600 and hookworms (Ancylostoma caninum (c) of this chapter. and Uncinaria stenocephala). (c) Conditions of use. Dogs(1) Amount. 5 (4) Cats and kittens: Removal and to 10 milligrams per pound of body control of intestinal roundworms weight, three times daily. In severe (Toxocara cati and Toxascaris leonina) cases, up to 25 milligrams per pound of and hookworms (Ancylostoma body weight three times daily. tubaeforme and Uncinaria stenocephala). (2) Indications for use. Treatment of (5) Dichlorvos is a cholinesterase in- pyoderma (pyogenic dermatitis) due to hibitor. Do not use simultaneously penicillinase-producing staphylococci with or within a few days before or sensitive to the drug. after treatment with or exposure to (3) Limitations. For the treatment of cholinesterase-inhibiting drugs, pes- dogs only. Continue treatment for 24 to ticides, or chemicals. 48 hours after the animal has become (6) Do not use in animals under 10 afebrile or asymptomatic, Administer 1 days of age or 1 pound of body weight. to 2 hours before feeding to ensure (7) Do not administer to animals maximum absorption. Not for use in showing signs of constipation, mechan- animals which are raised for food pro- ical blockage of the intestinal tract, duction. Federal law restricts this drug impaired liver function, or recently ex- to use by or on the order of a licensed posed to or showing signs of infectious veterinarian. disease. [57 FR 37325, Aug. 18, 1992] (8) Do not use in dogs or puppies infected with Dirofilaria immitis. § 520.620 Diethylcarbamazine oral dos- (9) Federal law restricts this drug to age forms. use by or on the order of a licensed vet- § 520.622 Diethylcarbamazine citrate erinarian. oral dosage forms. [40 FR 13838, Mar. 27, 1975, as amended at 48 FR 40704, Sept. 9, 1983; 51 FR 28546, Aug. 8, § 520.622a Diethylcarbamazine citrate 1986; 62 FR 35076, June 30, 1997; 64 FR 18571, tablets. Apr. 15, 1999; 78 FR 21059, Apr. 9, 2013] (a) Sponsors. (1) [Reserved] (2) See 053501 in § 510.600(c) of this § 520.606 Diclazuril. chapter for use of 100, 200, and 300 milli- (a) Specifications. Each 100 grams (g) gram tablets for prevention of heart- of pellets contain 1.56 g diclazuril. worm disease in dogs and as an aid in

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the treatment of ascarid infections in (3) Conditions of use. (i) The drug is dogs. indicated for use in dogs for the pre- (3) See 061623 in § 510.600(c) of this vention of infection with Dirofilaria chapter for use of 50, 100, 200, 300, or 400 immitis and T. canis and T. leonina. It is milligram tablets for prevention of also indicated for treatment of ascarid heartworm disease in dogs, as an aid in infections of T. canis and T. leonina in the control of ascarid infections in dogs and T. cati in cats. dogs, and as an aid in the treatment of (ii) For prevention of heartworm and ascarid infections in dogs and cats. ascarid infections in dogs, the drug (4) [Reserved] may be added to the daily diet at a dos- (5) See No. 000061 in § 510.600(c) of this age rate of 3.0 milligrams per pound of chapter for use of 60, 120, or 180 milli- body weight per day or given directly gram tablets for prevention of heart- by mouth at the same dosage rate. For worm disease in dogs, as an aid in the treatment of ascarid infections in dogs control of ascarid infections in dogs, and cats, the drug is administered at a and as an aid in the treatment of asca- dosage level of 25 to 50 milligrams per rid infections in dogs and cats. pound of body weight preferably ad- (6) See No. 054628 in § 510.600(c) of this ministered immediately after feeding. chapter for use of 50, 100, 200, 300, or 400 (iii) Older dogs should be proven neg- milligram tablets for prevention of ative for the presence of Dirofilaria heartworm disease in dogs, as an aid in immitis infection before administration the control of ascarid infections in of the drug. Those with proven infec- dogs, and as an aid in the treatment of tion of Dirofilaria immitis should be ren- ascarid infections in dogs and cats. dered negative using adulticidal and (b) Conditions of use(1) Dosage/indica- microfilaricidal drugs before adminis- tions for use. (i) Three milligrams per pound of body weight daily for preven- tration of this drug. tion of heartworm disease (Dirofilaria (iv) Federal law restricts this drug to immitis) in dogs. use by or on the order of a licensed vet- (ii) Three milligrams per pound of erinarian. body weight daily as an aid in the con- (b) [Reserved] trol of ascarid infections (Toxocara (c)(1) Specifications. Each milliliter of canis) in dogs. syrup contains 60 milligrams of (iii) Twenty-five to 50 milligrams per diethylcarbamazine citrate. pound of body weight as an aid in the (2) Sponsor. See No. 054628 in treatment of ascarid infections in dogs § 510.600(c) of this chapter. (Toxocara canis) and cats (Toxocara (3) Conditions of use. (i) The drug is canis and Toxascaris leonina). used in dogs between 4 weeks and 8 (2) Limitations. Federal law restricts months of age for the removal of this drug to use by or on the order of a ascarids (Toxacara canis) and in ani- licensed veterinarian. mals over 4 weeks of age for the pre- [46 FR 23230, Apr. 24, 1981, as amended at 46 vention of heartworm disease FR 41038, Aug. 14, 1981; 46 FR 46315, Sept. 18, (Dirofilaria immitis). 1981; 46 FR 61653, Dec. 18, 1981; 47 FR 10805, (ii) The drug is administered (a) for Mar. 12, 1982; 47 FR 14150, Apr. 2, 1982; 50 FR removal of ascarids at a dosage of 50 41489, Oct. 11, 1985; 50 FR 49372, Dec. 2, 1985; milligrams per pound of body weight 53 FR 40056, Oct. 13, 1988; 53 FR 40727, Oct. 18, divided into two equal doses and ad- 1988; 55 FR 8461, Mar. 8, 1990; 61 FR 34728, ministered 8 to 12 hours apart (morning July 3, 1996; 62 FR 35076, June 30, 1997; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 76 and night), orally or mixed with either FR 17777, Mar. 31, 2011; 77 FR 4896, Feb. 1, dry or wet food, and (b) for prevention 2012; 78 FR 21059, Apr. 7, 2013] of heartworm disease at a dosage of 3 milligrams per pound of body weight § 520.622b Diethylcarbamazine citrate daily, orally or in food, in heartworm syrup. endemic areas, from the beginning of (a)(1) Specifications. Each milliliter of mosquito activity, during the mosquito syrup contains 60 milligrams of season, and for 2 months following the diethylcarbamazine citrate. end thereof. (2) Sponsor. See No. 053501 in (iii) Dogs older than 8 months of age § 510.600(c) of this chapter. may be infected with Dirofilaria immitis.

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Use of the drug is contraindicated in (3) Limitations. Federal law restricts dogs with active D. immitis infections. this drug to use by or on the order of a (iv) Federal law restricts this drug to licensed veterinarian. use by or on the order of a licensed vet- [43 FR 6941, Feb. 17, 1978] erinarian. EDITORIAL NOTE: For FEDERAL REGISTER ci- [40 FR 13838, Mar. 27, 1975, as amended at 41 tations affecting § 520.622c, see the List of FR 28265, July 9, 1976; 44 FR 3967, Jan. 19, CFR Sections Affected, which appears in the 1979; 47 FR 14150, Apr. 2, 1982; 47 FR 35186, Finding Aids section of the printed volume Aug. 13, 1982; 49 FR 33997, Aug. 28, 1984; 50 FR and at www.fdsys.gov. 41489, Oct. 11, 1985; 53 FR 47027, Oct. 18, 1988; 61 FR 34728, July 3, 1996; 62 FR 35076, June 30, § 520.623 Diethylcarbamazine citrate, 1997; 62 FR 38906, July 21, 1997; 77 FR 4897, oxibendazole chewable tablets. Feb. 1, 2012; 78 FR 21059, Apr. 9, 2013] (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 000069 in § 510.600(c) of rate. 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 000069, 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 (3) For 061690, use of 45 or 150 milli- body weight (2.27 milligrams per pound gram tablets as in paragraph (c)(2)(iii) of body weight). of this section. (2) Indications for use. For prevention (4) For 061133, use of 60-, 120-, or 180- of infection with Dirofilaria immitis milligram tablets as in paragraph (heartworm disease) and Ancylostoma (c)(2)(i) of this section. caninum (hookworm infection) and for (5) For 000061, use of 60-milligram removal and control of Trichuris vulpis tablets as in paragraph (c)(2)(i) of this (whipworm infection) and mature and section. immature stages of intestinal Toxocara (6) For 054628, use of 30, 60, 120, or 180 canis (ascarid infection). milligram tablets as in paragraph (3) Limitations. Orally administer (c)(2)(i) of this section. daily during heartworm season. For (c) Conditions of use(1) Amount. 3 mil- free-choice feeding or broken and ligrams per pound of body weight per placed on or mixed with feed. Do not day for prevention of heartworm dis- use in dogs that may harbor adult ease and control of ascarids; 25 to 50 heartworms. Federal law restricts this milligrams per pound of body weight as drug to use by or on the order of a lian aid in treatment of ascarid infec- censed veterinarian. tions. [50 FR 28768, July 16, 1985, as amended at 53 (2) Indications for use. (i) For preven- FR 45759, Nov. 14, 1988; 54 FR 3776, Jan. 26, tion of heartworm disease (Dirofilaria 1989; 54 FR 6804, Feb. 14, 1989; 56 FR 50653, immitis) in dogs; as an aid in control of Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995] ascarids (Toxocara canis) in dogs; as an aid in treatment of ascarid (Toxocara § 520.645 Difloxacin. canis and Toxascaris leonina) infections (a) Specifications. Each tablet con- in dogs and cats. tains 11.4, 45.4, or 136 milligrams (mg) (ii) For prevention of infection with of difloxacin hydrochloride. Dirofilaria immitis (heartworm disease) (b) Sponsor. See No. 000010 in in dogs; as an aid in treatment of asca- § 510.600(c) of this chapter. rid (Toxocara canis and Toxascaris (c) [Reserved] leonina) infections in dogs. (d) Conditions of use—(i) Amount. Ad- (iii) For prevention of heartworm dis- minister 5 to 10 mg per kilogram (2.3 to ease (Dirofilaria immitis) in dogs. 4.6 mg per pound) of body weight orally

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once a day for 2 to 3 days beyond ces- Milligrams Length of sation of clinical signs of disease up to per pound of body treatment— a maximum of 30 days. weight days (ii) Indications for use. For manage- Large roundworms (Toxocara ment of diseases in dogs associated canis, Toxascaris leonina) ...... 10 3–5 with bacteria susceptible to difloxacin. Hookworms (Ancylostoma (iii) Limitations. Federal law prohibits caninum, Uncinaria the extra-label use of this drug in food- stenocephala) ...... 10 7 producing animals. Federal law re- Whipworms (Trichuris vulpis) ...... 10 Strongyloides (Strongyloides stricts this drug to use by or on the canis, Strongyloides order of a licensed veterinarian. stercoralis) ...... 10 10–12 (2) [Reserved] Heartworm microfilariae (Dirofilaria immitus) ...... 3–5 7–10 [63 FR 8123, Feb. 18, 1998, as amended at 75 Note: Treatment with dithiazanine iodide for heartworm FR 10165, Mar. 5, 2010] microfilariae should follow 6 weeks after therapy for adult worms. § 520.666 Dirlotapide. (2) The drug is contraindicated in (a) Specifications. Each milliliter animals sensitive to dithiazanine io- (mL) of solution contains 5 milligrams dide and should be used cautiously, if (mg) dirlotapide. at all, in dogs with reduced renal func- (b) Sponsor. See No. 000069 in tion. § 510.600(c) of this chapter. (3) Federal law restricts this drug to (c) Conditions of use in dogs—(1) use by or on the order of a licensed vet- Amount. The initial dosage is 0.01 mL/ erinarian. kg (0.0045 mL/lb) body weight for the (e) Use for treating dogs for large first 14 days. After the first 14 days of roundworms, hookworms, whipworms, treatment, the dose volume is doubled and strongyloides as provided for in to 0.02 mL/kg (0.009 mL/lb) body weight this section has been NAS/NRC re- for the next 14 days (days 15 to 28 of viewed and deemed effective. Applica- treatment). Dogs should be weighed tions for these uses need not include ef- monthly and the dose volume adjusted fectiveness data as specified by § 514.111 every month, as necessary, to maintain of this chapter, but may require bio- a target percent weight loss until the equivalency and safety information. desired weight is achieved. (2) Indications for use. For the man- [40 FR 13838, Mar. 27, 1975, as amended at 47 FR 51564, Nov. 16, 1982; 48 FR 32342, July 15, agement of obesity. 1983; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, (3) Limitations. Federal law restricts June 30, 1997; 78 FR 21059, Apr. 9, 2013] this drug to use by or on the order of a licensed veterinarian. § 520.763b Dithiazanine iodide powder. [72 FR 263, Jan. 4, 2007] (a) [Reserved] (b) Specifications. Dithiazanine iodide § 520.763 Dithiazanine iodide oral dos- powder contains 200 milligrams of age forms. dithiazanine iodide per level standard tablespoon. § 520.763a Dithiazanine iodide tablets. (c) Sponsor. See No. 054628 in (a) [Reserved] § 510.600(c) of this chapter. (b) Specifications. Dithiazanine iodide (d) Conditions of use. (1) Dithiazanine tablets contain 10 milligrams, 50 milli- iodide powder is administered to dogs grams, 100 milligrams, or 200 milli- by mixing the proper dosage in the grams of dithiazanine iodide in each dog’s food, using the following dosage tablet. schedule for various parasite infesta- (c) Sponsor. See No. 054628 in tions: § 510.600(c) of this chapter. (d) Conditions of use. (1) The tablets Milligrams Length of per pound treatment— are administered orally to dogs imme- of body days diately after feeding using the fol- weight lowing dosage schedule for various Large roundworms (Toxocara parasite infestations: canis, Toxascaris leonina) ...... 10 3–5

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gle dose. Treatment is recommended in Milligrams Length of per pound spring and fall. In a heavily infested of body treatment— weight days environment, treatment may be repeated every 30 days. Not for use in Hookworms (Ancylostoma caninum, Uncinaria horses intended for food purposes. Se- stenocephala) ...... 10 7 verely debilitated animals should not Whipworms (Trichuris vulpis) ...... 10 7 be wormed except on the advice of a Strongyloides (Strongyloides veterinarian. If the drug is for adminis- canis, Strongyloides stercoralis) ...... 10 10–12 tration by stomach tube, it shall be la- Heartworm microfilariae beled: ‘‘Federal law restricts this drug (Dirofilaria immitus) ...... 3–5 7–10 to use by or on the order of a licensed Note: Treatment with dithiazanine iodide for heartworm veterinarian.’’ microfilariae should follow 6 weeks after therapy for adult worms. [47 FR 52696, Nov. 23, 1982, as amended at 48 FR 32342, July 15, 1983; 53 FR 40727, Oct. 18, (2) The drug is contraindicated in 1988; 62 FR 35076, June 30, 1997; 78 FR 21059, animals sensitive to dithiazanine io- Apr. 9, 2013] dide and should be used cautiously, if at all, in dogs with reduced renal func- § 520.766 Domperidone. tion. (a) Specifications. Each milliliter of (3) Federal law restricts this drug to gel contains 110 milligrams (mg) use by or on the order of a licensed vet- domperidone. erinarian. (b) Sponsor. See No. 043264 in § 510.600 (e) Use for treating dogs for large of this chapter. roundworms, hookworms, whipworms, (c) Conditions of use in horses—(1) and strongyloides as provided for in Amount. Administer 0.5 mg per pound this section has been NAS/NRC re- (mg/lb) (1.1 mg/kilogram (kg)) by viewed and deemed effective. Applica- mouth once daily starting 10 to 15 days tions for these uses need not include ef- prior to the expected foaling date. fectiveness data as specified by § 514.111 Treatment may be continued for up to of this chapter, but may require bio- 5 days after foaling if mares are not equivalency and safety information. producing adequate milk. [40 FR 13838, Mar. 27, 1975, as amended at 47 (2) Indications for use. For prevention FR 51564, Nov. 16, 1982; 48 FR 32342, July 15, of fescue toxicosis in periparturient 1983; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, mares. June 30, 1997; 78 FR 21059, Apr. 9, 2013] (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 [75 FR 67031, Nov. 1, 2010] the drug contains 69 milligrams of dithiazanine iodide and 83 milligrams § 520.784 Doxylamine succinate tab- of piperazine base (as piperazine cit- lets. rate). (a) Specifications. The drug is in tab- (b) Sponsor. See 054628 in § 510.600(c) of let form and contains doxylamine suc- this chapter. cinate as the active drug ingredient. (c) [Reserved] (b) Sponsor. See No. 000061 in (d) Conditions of use—(1) Amount. 1 § 510.600(c) of this chapter. ounce (30 milliliters) per 100 pounds of (c) Conditions of use. (1) The drug is body weight for the first 500 pounds; 3⁄4 used in conditions in which antihis- ounce for each 100 pounds thereafter, taminic therapy may be expected to al- up to 1,200 pounds; 101⁄4 ounces to ani- leviate some signs of disease in horses, mals over 1,200 pounds. dogs, and cats. 1 (2) Indications for use. For control of (2) It is administered orally to horses large roundworms, Parascaris equorum; at a dosage level of 1 to 2 milligrams small strongyles; large strongyles, Strongylus vulgaris; and pinworms, 1 These conditions are NAS/NRC reviewed Oxyuris equi. and deemed effective. Applications for these (3) Limitations. Administer by drench uses need not include effectiveness data as or mixed with the daily ration as a sin- specified by § 514.111 of this chapter.

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per pound of body weight per day di- (b) Sponsors. See sponsor numbers in vided into 3 or 4 equal doses. It is ad- § 510.600(c) of this chapter for use as in ministered orally to dogs and cats at a paragraph (c) of this section. dosage level of 2 to 3 milligrams per (1) Nos. 000859 and 026637 for use of pound of body weight per day divided product described in paragraph (a)(1) of into 3 or 4 equal doses. 1 this section. (3) Not for use in horses intended for (2) No. 058198 for use of product de- food. 1 scribed in paragraph (a)(2) of this sec- (4) Federal law restricts this drug to tion. use by or on the order of a licensed vet- (c) Conditions of use in dogs and cats— 1 erinarian. (1) Amount. Administer orally as a sin- [40 FR 13838, Mar. 27, 1975, as amended at 42 gle, daily dose or divided into two FR 60140, Nov. 25, 1977; 46 FR 48642, Oct. 2, equal doses at 12-hour intervals. 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, (i) Dogs. 5 to 20 mg per kilogram (/kg) Nov. 19, 1997] (2.27 to 9.07 mg per pound (/lb)) of body § 520.804 Enalapril tablets. weight. (ii) Cats. 5 mg/kg (2.27 mg/lb) of body (a) Specifications. Each tablet con- weight. tains either 1.0, 2.5, 5.0, 10.0, or 20.0 mil- (2) Indications for use. For the man- ligrams of enalapril maleate. agement of diseases associated with (b) Sponsor. See 050604 in § 510.600(c) of bacteria susceptible to enrofloxacin. this chapter. (3) Limitations. Federal law restricts (c) Conditions of use—(1) Dogs—(i) Amount. 0.5 to 1.0 milligram of this drug to use by or on the order of a enalapril maleate per kilogram of body licensed veterinarian. Federal law pro- weight per day. hibits the extralabel use of this drug in (ii) Indications for use. Treatment of food-producing animals. mild, moderate, and severe (modified [78 FR 30197, May 22, 2013, as amended at 78 New York Heart Association Class II, FR 52853, Aug. 27, 2013] III, IV) heart failure in dogs. (iii) Limitations. Use 0.5 milligram per § 520.816 Epsiprantel tablets. kilogram once daily. In the absence of (a) Specifications. Each tablet con- adequate clinical response within a 2- tains either 12.5, 25, 50, or 100 milli- week period, use may be increased to grams of epsiprantel. twice daily (a total of 1.0 milligram per (b) Sponsor. See No. 000069 in kilogram). Enalapril maleate is admin- § 510.600(c) of this chapter. istered as conjunctive therapy with furosemide and digoxin in the treat- (c) Conditions of use—(1) Dogs—(i) ment of dilated cardiomyopathy and Amount. 2.5 milligrams per pound of furosemide with or without digoxin in body weight. the treatment of chronic valvular dis- (ii) Indications for use. Removal of ca- ease. The safety of enalapril for use in nine cestodes Dipylidium caninum and breeding dogs has not been established. Taenia pisiformis. Use in pregnant bitches is not rec- (2) Cats—(i) Amount. 1.25 milligrams ommended. Federal law restricts this per pound of body weight. drug to use by or on the order of a li- (ii) Indications for use. Removal of fe- censed veterinarian. line cestodes D. caninum and T. (2) [Reserved] taeniaeformis. [59 FR 17694, Apr. 14, 1994, as amended at 62 (3) Limitations. For oral use only as a FR 63270, Nov. 28, 1997] single dose. Do not use in animals less than 7 weeks of age. Safety of use in § 520.812 Enrofloxacin. pregnant or breeding animals has not (a) Specifications. Each tablet con- been established. Federal law restricts tains: this drug to use by or on the order of a (1) 22.7, 68.0, or 136.0 milligrams (mg) licensed veterinarian. enrofloxacin; or [54 FR 50615, Dec. 8, 1989, as amended at 56 (2) 22.7, 68.0, 136.0, or 272 mg FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, enrofloxacin. 1995]

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§ 520.823 Erythromycin phosphate. sume enough medicated water to pro- (a) Specifications. Erythromycin phos- vide a therapeutic dosage; solutions phate is the phosphate salt of the anti- older than 3 days should not be used; biotic substance produced by the withdraw 1 day before slaughter. growth of Streptomyces erythreus or the [40 FR 13838, Mar. 27, 1975, as amended at 45 same antibiotic substance produced by FR 56798, Aug. 26, 1980; 66 FR 14073, Mar. 9, any other means. One gram of erythro- 2001; 68 FR 4914, Jan. 31, 2003] mycin phosphate is equivalent to 0.89 gram of erythromycin master stand- § 520.852 Estriol. ard. (a) Specifications. Each tablet con- (b) Sponsor. See No. 061623 in § 510.600(c) of this chapter. tains 1 milligram (mg) estriol. (c) Related tolerances. See § 556.230 of (b) Sponsor. See No. 000061 in this chapter. § 510.600(c) of this chapter. (d) Conditions of use. It is used in (c) Conditions of use in dogs—(1) drinking water as follows: Amount. Administer at an initial dose (1) Broiler and replacement chickens— of 2 mg per dog per day. The dosage (i) Amount. 0.500 gram per gallon. may be titrated to as low as 0.5 mg per (ii) Indications for use. As an aid in dog every second day, depending on re- the control of chronic respiratory dis- sponse. ease due to Mycoplasma gallisepticum (2) Indications for use. For the control susceptible to erythromycin. of estrogen-responsive urinary inconti- (iii) Limitations. Administer for 5 nence in ovariohysterectomized female days; do not use in replacement pullets dogs. over 16 weeks of age; do not use in (3) Limitations. Federal law restricts chickens producing eggs for human this drug to use by or on the order of a consumption; to assure effectiveness, treated birds must consume enough licensed veterinarian. medicated water to provide a thera- [76 FR 78150, Dec. 16, 2011] peutic dosage; solutions older than 3 days should not be used; withdraw 1 § 520.863 Ethylisobutrazine hydro- day before slaughter. chloride tablets. (2) Replacement chickens and chicken (a) Specifications. Each tablet con- breeders—(i) Amount. 0.500 gram per gal- tains either 10 milligrams or 50 milli- lon. grams of ethylisobutrazine hydro- (ii) Indications for use. As an aid in chloride. the control of infectious coryza due to Hemophilus gallinarum susceptible to (b) Sponsor. See No. 000061 in erythromycin. § 510.600(c) of this chapter. (iii) Limitations. Administer for 7 (c) Conditions of use. (1) It is adminis- days; do not use in replacement pullets tered orally to dogs as a tranquilizer.1 over 16 weeks of age; do not use in (2) It is administered once daily at a chickens producing eggs for human dosage level of 2 to 5 milligrams of consumption; to assure effectiveness, ethylisobutrazine hydrochloride per treated birds must consume enough pound of body weight.1 medicated water to provide a thera- (3) It is not to be used in conjunction peutic dosage; solutions older than 3 with organophosphates and/or procaine days should not be used; withdraw 1 hydrochloride because phenothiazine day before slaughter. may potentiate the toxicity of (3) Growing turkeys—(i) Amount. 0.500 organophosphates and the activity of gram per gallon. procaine hydrochloride.1 (ii) Indications for use. As an aid in the control of blue comb (nonspecific infectious enteritis) caused by orga- 1 These conditions are NAS/NRC reviewed nisms susceptible to erythromycin. and deemed effective. Applications for these (iii) Limitations. Administer for 7 uses need not include effectiveness data as days; do not use in turkeys producing specified by § 514.111 of this chapter, but may eggs for human consumption; to assure require bioequivalency and safety informa- effectiveness, treated birds must con- tion.

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(4) Federal law restricts this drug to occur, retreatment may be necessary. use by or on the order of a licensed vet- For most effective results, retreat in 6 erinarian.1 to 8 weeks. [40 FR 13838, Mar. 27, 1975, as amended at 46 (iv) Not for use in horses intended for FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; food. 62 FR 61624, Nov. 19, 1997] (v) Consult your veterinarian for assistance in the diagnosis, treatment, § 520.870 Etodolac. and control of parasitism. (a) Specifications. Each tablet contains 150, 300, or 500 milligrams (mg) of [43 FR 8797, Mar. 3, 1978; 43 FR 12311, Mar. 24, etodolac. 1978, as amended at 43 FR 60882, Dec. 29, 1978. Redesignated at 45 FR 8587, Feb. 8, 1980] (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. § 520.903b Febantel suspension. (c) [Reserved] (d) Conditions of use—(i) Amount. Ad- (a) Specifications. The suspension con- minister 10 to 15 mg per kilogram (4.5 tains 9.3 percent (2.75 grams per ounce) to 6.8 mg per pound) of body weight per febantel. day orally. (b) Sponsor. See 000859 in § 510.600(c) of (ii) Indications for use. For the man- this chapter. agement of pain and inflammation as- (c) Conditions of use—(1) Amount. 3 sociated with osteoarthritis in dogs. milliliters per 100 pounds body weight (iii) Limitations. Federal law restricts or 1 fluid ounce per 1000 pounds (6 mil- this drug to use by or on the order of a ligrams per kilogram body weight). licensed veterinarian. (2) Indications for use. For removal of (2) [Reserved] ascarids (Parascaris equorum—adult and [63 FR 51300, Sept. 25, 1998, as amended at 68 sexually immature), pinworms (Oxyuris FR 51705, Aug. 28, 2003; 75 FR 10166, Mar. 5, equi—adult and 4th stage larvae), large 2010] strongyles (Strongylus vulgaris, S. edentatus, S. equinus), and the various § 520.903 Febantel oral dosage forms. small strongyles in horses, breeding § 520.903a Febantel paste. stallions and mares, pregnant mares, foals, and ponies. (a) Chemical name. Dimethyl [[2- [(methoxyacetyl)amino]-4-(phenyl- (3) Limitations. Administer by stom- thio)phenyl] carbonimidoyl]bis [carba- ach tube or drench, or by mixing well mate]. into a portion of the normal grain ra- (b) Specifications. The drug is a paste tion. For animals maintained on prem- containing 45.5 percent febantel. ises where reinfection is likely to (c) Sponsor. See No. 000859 in occur, retreatment may be necessary. § 510.600(c) of this chapter. For most effective results, retreat in 6 (d) Conditions of use—(1) Amount. Six to 8 weeks. Not for use in horses in- milligrams per kilogram (2.73 milli- tended for food. Federal law restricts grams per pound) of body weight in this drug to use by or on the order of a horses. licensed veterinarian. (2) Indications for use. For removal of (d) Special considerations. Febantel large strongyles (Strongylus vulgaris, S. suspension may be used in combination edentatus, S. equinus); ascarids with trichlorfon oral liquid in accord- (Parascaris equorum— sexually mature ance with the provisions of § 520.2520c, and immature); pinworms (Oxyuris this section, and the following condi- equi— adult and 4th stage larva); and tions: the various small strongyles in horses, (1) Combine 1 part febantel suspen- foals, and ponies. sion with 5 parts trichlorfon liquid. (3) Limitations. (i) The paste may be (2) Allow animal to consume a por- administered on the base of the tongue tion of daily grain ration; administer or well mixed into a portion of the nor- mixture by stomach tube at rate of 18 mal grain ration. milliliters per 100 pounds of body (ii) [Reserved] weight. (iii) For animals maintained on premises where reinfection is likely to [45 FR 8587, Feb. 8, 1980]

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§ 520.903c [Reserved] gram body weight. Administer once daily for 3 consecutive days. § 520.903d Febantel-praziquantel (ii) Puppies and kittens fewer than 6 paste. months of age. Fifteen milligrams per (a) Specifications. Each gram of paste kilogram body weight. Administer once contains 34 milligrams of febantel and daily for 3 consecutive days. 3.4 milligrams of praziquantel. (2) Indications for use. (i) For removal (b) Sponsor. See No. 000859 in of hookworms (Ancylostoma caninum § 510.600(c) of this chapter. and Uncinaria stenocephala), ascarids (c) Conditions of use—(1) Amount—(i) (Toxocara canis and Toxascaris leonina) Dogs and cats (over 6 months of age): 10 and whipworms (Trichuris vulpis) in milligrams of febantel and 1 milligram dogs and puppies. of praziquantel per kilogram of body (ii) For removal of hookworms weight (1 gram of paste per 7.5 pounds (Ancylostoma tubaeforme) and ascarids body weight) administered by mouth or (Toxocara cati) in cats and kittens. in the food once daily for 3 days. (3) Limitations. Do not use in preg- (ii) Puppies and kittens (less than 6 nant animals. Consider alternative months of age): 15 milligrams of therapy or use with caution in animals febantel and 1.5 milligrams of with preexisting liver or kidney dys- praziquantel per kilogram of body function. Administer to puppies and weight (1 gram of paste per 5 pounds kittens on a full stomach. Federal law body weight) administered by mouth restricts this drug to use by or on the on a full stomach once daily for 3 days. order of a licensed veterinarian. (2) Indications for use. (i) Dogs and [56 FR 50655, Oct. 8, 1991] puppies: For removal of hookworms (Ancylostoma caninum and Uncinaria § 520.905 Fenbendazole oral dosage stenocephala), whipworms (Trichuris forms. vulpis), ascarids (Toxocara canis and § 520.905a Fenbendazole suspension. Toxascaris leonina), and tapeworms (Dipylidium caninum and Taenia (a) Specifications. Each milliliter of pisiformis). suspension contains 100 milligrams (ii) Cats and kittens: For removal of (mg) fenbendazole. hookworms (Ancylostoma tubaeforme), (b) Sponsor. See No. 000061 in ascarids (Toxocara cati) and tapeworms § 510.600(c) of this chapter. (Dipylidium caninum and Taenia (c) Related tolerances. See § 556.275 of taeniaeformis). this chapter. (3) Limitations. Do not use in preg- (d) Special considerations. (1) See nant animals. Federal law restricts § 500.25 of this chapter. this drug to use by or on the order of a (2) Fenbendazole suspension 10 per- licensed veterinarian. cent and approved forms of trichlorfon, when used concomitantly for treating (4) Special considerations. Consider al- the indications provided in paragraph ternative therapy or use with caution (e) of this section and for treating in- in animals with pre-existing liver or fections of stomach bot as provided in kidney dysfunction. § 520.2520, have been shown to be com- [50 FR 19167, May 7, 1985, as amended at 53 patible and not to interfere with one FR 48533, Dec. 1, 1988; 56 FR 50813, Oct. 9, another. 1991] (e) Conditions of use—(1) Horses—(i) Amount. Administer orally 5 mg per § 520.903e Febantel tablets. kilogram (/kg) (2.3 mg per pound (/lb)) (a) Specifications. Each scored tablet for the control of large strongyles, contains 27.2 milligrams of febantel for small strongyles, and pinworms; 10 mg/ use in dogs, puppies, cats, and kittens kg for the control of ascarids. or 163.3 milligrams of febantel for use (ii) Indications for use. For the control in dogs, puppies, and cats. of large strongyles (Strongylus (b) Sponsor. See 000859 in § 510.600(c)(2) edentatus, S. equinus, S. vulgaris), small of this chapter. strongyles (Cyanthostomum spp., (c) Conditions of use—(1) Amount—(i) Cylicocyclus spp., Cylicostephanus spp., Dogs and cats. Ten milligrams per kilo- Triodontophorus spp.), pinworms

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(Oxyuris equi), and ascarids (Parascaris (adults) Haemonchus contortus and equorum) in horses. Teladorsagia circumcincta. (iii) Limitations. Administer by dose (iii) Limitations. Retreatment may be syringe or suitable plastic syringe. Do needed after 4 to 6 weeks. Goats must not use in horses intended for human not be slaughtered for food within 6 consumption. days following last treatment. Do not (2) Cattle including dairy cows of breed- use in lactating goats. ing age—(i) Amount. Administer orally 5 [42 FR 59069, Nov. 15, 1977; 43 FR 12311, Mar. mg/kg of body weight (2.3 mg/lb). Re- 24, 1978. Redesignated at 44 FR 1375, Jan. 5, treatment may be needed after 4 to 6 1979, and amended at 46 FR 29464, June 2, weeks. 1981; 47 FR 15327, Apr. 9, 1982; 48 FR 42809, (ii) Indications for use. For the re- Sept. 20, 1983; 49 FR 1983, Jan. 17, 1984; 53 FR moval and control of lungworm 40058, Oct. 13, 1988; 59 FR 26943, May 25, 1994; 61 FR 29478, June 11, 1996; 63 FR 63983, Nov. (Dictyocaulus viviparus); stomach worm 18, 1998; 66 FR 47960, Sept. 17, 2001; 68 FR (adults)—brown stomach worm 26205, May 15, 2003; 74 FR 17770, Apr. 17, 2009; (Ostertagia ostertagi); stomach worms 74 FR 61516, Nov. 25, 2009; 76 FR 17336, Mar. (adults and 4th-stage larvae)— 29, 2011] barberpole worm (Haemonchus contortus and H. placei) and small stomach worm § 520.905b Fenbendazole granules. (Trichostongylus axei); intestinal worms (a) Specifications. Each gram of gran- (adults and 4th-stage larvae)— ules contains 222 milligrams (mg) hookworm (Bunostonmum phlebotomum), fenbendazole. threadnecked intestinal worm (b) Sponsor. See No. 000061 in (Nematodirus helvetianus), small intes- § 510.600(c) of this chapter. tinal worm (Cooperia punctata and C. (c) Special considerations. See § 500.25 oncophora), bankrupt worm of this chapter. (Trichostrongylus colubriformis), and (d) Conditions of use—(1) Horses—(i) nodular worm (Oesophagostomum Amount. 5 mg/kilogram (kg) for large radiatum). strongyles, small strongyles, and (iii) Limitations. Cattle must not be pinworms; 10 mg/kg for ascarids. slaughtered within 8 days following (ii) Indications for use. For the control last treatment. A withdrawal period of infections of large strongyles has not been established for this prod- (Strongylus edentatus, S. equinus, S. uct in preruminating calves. Do not vulgaris), small strongyles, pinworms use in calves to be processed for veal. (Oxyuris equi), and ascarids (Parascaris (3) Beef cattle—(i) Amount. Administer equorum). orally 10 mg/kg of body weight (2.3 mg/ (iii) Limitations. Sprinkle the appro- lb). Retreatment may be needed after 4 priate amount of drug on a small to 6 weeks. amount of the usual grain ration. Pre- (ii) Indications for use. For the re- pare for each horse individually. With- moval and control of stomach worm holding feed or water is not necessary. (4th stage inhibited larvae/type II Retreat in 6 to 8 weeks if required. Do ostertagiasis), Ostertagia ostertagi, and not use in horses intended for food. tapeworm, Moniezia benedeni. (2) Dogs—(i) Amount. 50 mg/kg daily (iii) Limitations. Cattle must not be for 3 consecutive days. slaughtered within 8 days following (ii) Indications for use. For the treat- last treatment. A withdrawal period ment and control of ascarids (Toxocara has not been established for this prod- canis, Toxascaris leonina), hookworms uct in preruminating calves. Do not (Ancylostoma caninum, Uncinaria use in calves to be processed for veal. stenocephala), whipworms (Trichuris Federal law restricts this drug to use vulpis), and tapeworms (Taenia by or on the order of a licensed veteri- pisiformis). narian. (iii) Limitations. Mix the appropriate (4) Goats—(i) Amount. Administer amount of drug with a small amount of orally 5 mg/kg of body weight (2.3 mg/ the usual food; dry dog food may re- lb). quire slight moistening to facilitate (ii) Indications for use. For the re- mixing. Medicated food must be fully moval and control of stomach worms consumed.

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(3) Zoo and wildlife animals—(i) weight. Retreatment at intervals of 6 Amount. 10 mg/kg per day for 3 days. to 8 weeks may be required. (ii) Indications for use. For control of (B) For control of arteritis caused by internal parasites of Felidae and the fourth-stage larvae of S. vulgaris: Ursidae as follows: 4.6 mg/lb of body weight daily for 5 (A) Lion (Panthera leo) and Tiger days. Treatment should be initiated in (Panthera tigris): Ascarid (Toxocara cati, the spring and repeated in 6 months. Toxascaris leonina), Hookworm (C) For treatment of encysted (Ancylostoma spp.). mucosal cyathostome (small strongyle) (B) Cheetah (Acinonyx jubatus): Asca- larvae including early third-stage rid (Toxocara cati, Toxascaris leonina). (hypobiotic), late third-stage, and (C) Puma (Felis concolor), Panther fourth-stage larvae: 4.6 mg/lb of body (Panthera spp.), Leopard (Panthera weight daily for 5 consecutive days. pardus), Jaguar (Panthera onca): Asca- (D) Fenbendazole paste 10 percent rid (Toxocara cati, Toxascaris leonina), may be used concomitantly with ap- Hookworm (Ancylostoma spp.), Tape- worm (Taenia hydatigena, T. krabbei, T. proved forms of trichlorfon for the in- taeniaeformis). dications provided in paragraph (D) Black Bear (Ursus americanus): (e)(1)(i)(A) of this section and for treat- Ascarid (Baylisascaris transfuga, ing infections of stomach bots as pro- Toxascaris leonina), Hookworm vided in § 520.2520. (Ancylostoma caninum), Tapeworm (ii) Limitations. Do not use in horses (Taenia hydatigena, T. krabbei). intended for human consumption. (E) Polar Bear (Ursus maritimus) and (2) Cattle—(i) Amount. 2.3 mg/lb of Grizzly Bear (Ursus horribilis): Ascarid body weight. Retreatment may be (Baylisascaris transfuga, Toxascaris needed after 4 to 6 weeks. leonina). (ii) Indications for use. For the re- (iii) Limitations. Top dress or mix moval and control of lungworms with a small portion of food. Must be (Dictyocaulus viviparus), stomach fully consumed prior to feeding. Fed- worms (Haemonchus contortus, eral law restricts this drug to use by or Ostertagia ostertagi, Trichostrongylus on the order of a licensed veterinarian. axei), and intestinal worms Do not use 14 days before or during the (Bunostomum phlebotomum, Nematodirus hunting season. helvetianus, Cooperia punctata, C. [44 FR 1375, Jan. 5, 1979, as amended at 47 FR oncophora, Trichostrongylus 15327, Apr. 9, 1982; 48 FR 50528, Nov. 2, 1983; 59 colubriformis, and Oesophagostomum FR 35252, July 11, 1994; 66 FR 47960, Sept. 17, radiatum). 2001; 67 FR 47450, July 19, 2002; 71 FR 19429, (iii) Limitations. Cattle must not be Apr. 14, 2006; 74 FR 61516, Nov. 25, 2009] slaughtered within 8 days following last treatment. A withdrawal period § 520.905c Fenbendazole paste. has not been established for this prod- (a) Specifications. Each gram of paste uct in preruminating calves. Do not contains 100 milligrams (mg) use in calves to be processed for veal. fenbendazole (10 percent). (b) Sponsor. See No. 000061 in [72 FR 24185, May 2, 2007, as amended at 74 § 510.600(c) of this chapter. FR 61516, Nov. 25, 2009; 76 FR 17337, Mar. 29, 2011] (c) Related tolerances. See § 556.275 of this chapter. § 520.905d Fenbendazole powder. (d) Special considerations. See § 500.25 of this chapter. (a) Specifications. (1) Each 2-ounce (e) Conditions of use—(1) Horses—(i) packet contains 2.27 grams (4 percent) Indications for use and amounts—(A) For of fenbendazole plus other inert ingre- control of large strongyles (Strongylus dients. edentatus, S. equinus, S. vulgaris), small (2) Each 4-ounce packet contains 1.7 strongyles, pinworms (Oxyuris equi), grams (1.5 percent) of fenbendazole plus and ascarids (Parascaris equorum): 2.3 other inert ingredients. mg per pound (/lb) of body weight, or (b) Sponsors. (1) See No. 000061 in for foals and weanlings (less than 18 § 510.600(c) of this chapter for use of the months of age), 4.6 mg/lb of body 4-percent product.

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(2) See No. 051311 in § 510.600(c) of this Trichostrongylus colubriformis, and chapter for use of the 1.5-percent prod- Oesophagostomum radiatum) in beef cat- uct. tle. (c) Related tolerances. See § 556.275 of (3) Limitations. Administer free choice this chapter. of beef cattle on pasture that have be- (d) Conditions of use. It is adminis- come accustomed to nonmedicated tered to swine as follows: block feeding during an adaptation pe- (1) Amount. 3 milligrams fenbendazole riod of 12 to 19 days. Molasses block: per kilogram body weight per day (1.36 Cattle must not be slaughtered within milligrams per pound per day). 11 days following last treatment. Pro- (2) Indications for use. For removal tein block: Cattle must not be slaugh- and control of large roundworms tered within 16 days following last (Ascaris suum); lungworms treatment; do not use in dairy cattle of (Metastrongylus apri); nodular worms breeding age. Animals maintained (Oesophagostomum dentatum, O. under conditions of constant worm ex- quadrispinulatum); small stomach posure may require retreatment within worms (Hyostrongylus rubidus); 6 to 8 weeks. Consult your veterinarian whipworms (Trichuris suis); and for assistance in the diagnosis, treat- kidneyworms (Stephanurus dentatus— ment, and control of parasitism. mature and immature). (3) Limitations. Thoroughly mix the [51 FR 41783, Nov. 19, 1986, as amended at 54 FR 20787, May 15, 1989; 66 FR 47960, Sept. 17, contents of the packet(s) with swine 2001; 74 FR 61516, Nov. 25, 2009] ration and administer according to label directions. Feed as sole ration for § 520.928 Firocoxib tablets. 3 consecutive days. Can be fed to pregnant sows. No prior withdrawal of feed (a) Specifications. Each chewable tab- or water is necessary. Consult your let contains 57 or 227 milligrams (mg) veterinarian for assistance in the diag- firocoxib. nosis, treatment, and control of para- (b) Sponsor. See No. 050604 in sitism. § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) [49 FR 18090, Apr. 27, 1984, as amended at 49 Amount. 5 mg/kg (2.27 mg/lb) body FR 20485, May 15, 1984; 66 FR 47960, Sept. 17, weight. Administer once daily for os- 2001; 70 FR 32489, June 3, 2005; 74 FR 61516, teoarthritis. Administer approximately Nov. 25, 2009] 2 hours before soft-tissue or orthopedic § 520.905e Fenbendazole blocks. surgery. (2) Indications for use. For the control (a) Specifications. (1) Each pound of of pain and inflammation associated molasses block contains 750 milligrams with osteoarthritis; and for the control of fenbendazole. of postoperative pain and inflamma- (2) Each pound of protein block con- tion associated with soft-tissue and or- tains 750 milligrams of fenbendazole. thopedic surgery. (b) Sponsor. See 000061 in § 510.600(c) of (3) 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. (d) Conditions of use—(1) Amount. 0.1 [69 FR 51171, Aug. 18, 2004, as amended at 73 pound of block per 100 pounds of body FR 2808, Jan. 16, 2008; 73 FR 64885, Oct. 31, weight per day for 3 days. Total dose 2008] for the 3-day period is 2.27 milligrams of fenbendazole per pound of body § 520.930 Firocoxib paste. weight for mature cattle. (a) Specifications. Each milligram (2) Indications for use. For removal (mg) of paste contains 0.82 mg and control of infections of lungworms firocoxib. (Dictyocaulus viviparus) and gastro- (b) Sponsors. See No. 050604 in intestinal roundworms (Haemonchus § 510.600(c) of this chapter. contortus, Ostertagia ostertagi, (c) Conditions of use in horses—(1) Trichostrongylus axei, Bunostomum Amount. 0.1 mg per kilogram (0.045 mg phlebotomum, Nematodirus helvetianus, per pound) body weight daily for up to Cooperia oncophora and C. punctata, 14 days.

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(2) Indications for use. For the control (3) Limitations. Do not use in viral in- of pain and inflammation associated fections. Anti-inflammatory action of with osteoarthritis. corticosteroids may mask signs of in- (3) Limitations. Do not use in horses fection. Do not use in animals with tu- intended for human consumption. Fed- berculosis, chronic nephritis, eral law restricts this drug to use by or cushingoid syndrome, or where peptic on the order of a licensed veterinarian. ulcers occur, except for emergency therapy. Clinical and experimental [71 FR 5788, Feb. 3, 2006] data have demonstrated that § 520.955 Florfenicol. corticosteroids administered orally or parenterally to animals may induce (a) Specifications. Each milliliter the first stage of parturition when ad- (mL) contains 23 milligrams (mg) ministered during last trimester of florfenicol. pregnancy and may precipitate pre- (b) Sponsor. See Nos. 000061 and 058198 mature parturition followed by in § 510.600(c) of this chapter. dystocia, fetal death, retained pla- (c) Related tolerances. See § 556.283 of centa, and metritis. Federal law re- this chapter. stricts this drug to use by or on the (d) Conditions of use in swine—(1) order of a licensed veterinarian. Amount. Administer in drinking water ad libitum at 400 mg per gallon (100 [44 FR 7131, Feb. 6, 1979, as amended at 61 FR parts per million (ppm)) for 5 consecu- 5506, Feb. 13, 1996] tive days. (2) Indications for use. For the treat- § 520.970 Flunixin. ment of swine respiratory disease (a) Specifications. (1) Each 10-gram (g) (SRD) associated with Actinobacillus packet of granules contains flunixin pleuropneumoniae, Pasteurella multocida, meglumine equivalent to 250 milli- Salmonella choleraesuis and Strepto- grams (mg) of flunixin. coccus suis. (2) Each 30-g syringe of paste con- (3) Limitations. Do not slaughter with- tains flunixin meglumine equivalent to in 16 days of last treatment. Federal 1,500 mg of flunixin. law restricts this drug to use by or on (b) Sponsor. See No. 000061 in the order of a licensed veterinarian. § 510.600(c) of this chapter. [67 FR 78357, Dec. 24, 2002, as amended at 72 (c) Conditions of use in horses—(1) FR 262, Jan. 4, 2007; 78 FR 52854, Aug. 27, 2013] Amount. 0.5 mg of flunixin per pound of body weight per day. § 520.960 Flumethasone tablets. (2) Indications for use. For alleviation (a) Specifications. Each tablet con- of inflammation and pain associated tains 0.0625 milligram of flumethasone. with musculoskeletal disorders. (b) Sponsor. See No. 000856 in (3) Limitations. Do not use in horses § 510.600(c) of this chapter. intended for human consumption. Fed- (c) Conditions of use—(1) Amount. (i) eral law restricts this drug to use by or Dogs: Administer orally from 0.0625 to on the order of a licensed veterinarian. 0.25 milligram daily in divided doses. (ii) Cats: Administer orally from [76 FR 53051, Aug. 25, 2011] 0.03125 to 0.125 milligram daily in di- § 520.980 Fluoxetine. vided doses. (2) Indications for use. (i) Dogs: It is (a) Specifications. Each chewable tab- used for musculoskeletal conditions let contains 8, 16, 32, or 64 milligrams due to inflammation of muscles or (mg) fluoxetine hydrochloride. joints and accessory structures, where (b) Sponsor. See No. 000986 in § 510.600 permanent structural changes do not of this chapter. exist, such as arthritis, the disc syn- (c) Conditions of use in dogs—(1) drome, and myositis. Amount. 1 to 2 mg per kilogram body (ii) Dogs and cats: It is used in certain weight once daily. acute and chronic dermatoses of vary- (2) Indications for use. For the treating etiology to help control the pru- ment of canine separation anxiety in ritus, irritation, and inflammation as- conjunction with a behavior modifica- sociated with these conditions. tion plan.

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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 treatment of edema (pulmonary congestion, [72 FR 6463, Feb. 12, 2007] ascites) associated with cardiac insuffi- § 520.1010 Furosemide. ciency and acute noninflammatory tissue edema. (a) Specifications. (1) Each tablet con- (B) For treatment of edema (pul- tains 12.5 or 50 milligrams (mg) monary congestion, ascites) associated furosemide. with cardiac insufficiency. (2) Each bolus contains 2 grams (g) (3) Cats—(i) Amount. 1 to 2 mg/lb body furosemide. weight, once or twice daily. (3) Each packet of powder contains 2 (ii) Indications for use. For treatment g furosemide. of edema (pulmonary congestion, asci- (4) Each milliliter of syrup contains tes) associated with cardiac insuffi- 10 mg furosemide. ciency and acute noninflammatory tis- (b) Sponsors. See sponsor numbers in sue edema. § 510.600(c) of this chapter for use of [66 FR 47960, Sept. 17, 2001, as amended at 69 dosage forms and strengths listed in FR 74419, Dec. 14, 2004; 70 FR 50182, Aug. 26, paragraph (a) of this section for uses as 2005; 70 FR 76396, Dec. 27, 2005; 74 FR 61516, in paragraph (d) of this section. Nov. 25, 2009; 78 FR 17596, Mar. 22, 2013] (1) No. 000010 for tablets in paragraph (a)(1) of this section for conditions of § 520.1044 Gentamicin sulfate oral dos- use in paragraphs (d)(2)(i), (d)(2)(ii)(A), age forms. and (d)(3) of this section. § 520.1044a Gentamicin sulfate oral so- (2) No. 000061 for tablets in paragraph lution. (a)(1) of this section for conditions of (a) Each milliliter of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), Specifications. aqueous solution contains gentamicin and (d)(3) of this section; for boluses in sulfate equivalent to 50 milligrams of paragraph (a)(2) of this section and gentamicin. powder in paragraph (a)(3) of this sec- (b) Sponsor. See Nos. 000061 and 054925 tion for conditions of use in paragraph in § 510.600(c) of this chapter. (d)(1) of this section; and for syrup in (c) Related tolerances. See § 556.300 of paragraph (a)(4) of this section for con- this chapter. ditions of use in paragraphs (d)(2)(i) (d) Conditions of use—(1) Amount. and (d)(2)(ii)(A). Colibacillosis: 1 milliliter per 2 gallons (3) Nos. 000859 and 058829 for use of of drinking water for 3 consecutive syrup in paragraph (a)(4) of this section days, to provide 0.5 milligram/pound/ for conditions of use in paragraph day; swine dysentery: 1 milliliter per 1 (d)(2)(i) and (d)(2)(ii)(A) of this section. gallon of drinking water for 3 consecu- (c) Special considerations. Federal law tive days, to provide 1.0 milligram/ restricts this drug to use by or on the pound/day. order of a licensed veterinarian. (2) Indications for use. In weanling (d) Conditions of use. It is used as fol- swine for control and treatment of lows: colibacillosis caused by strains of E. (1) Cattle—(i) Amount. 1 to 2 mg per coli sensitive to gentamicin, and in pound (/lb) body weight using powder, swine for control and treatment of or one 2-g bolus per animal, per day. swine dysentery associated with (ii) Indications for use. For treatment Treponema hyodysenteriae. of physiological parturient edema of (3) Limitations. For use in swine the mammary gland and associated drinking water only. Do not store or structures. offer medicated drinking water in (iii) Limitations. Treatment not to ex- rusty containers since the drug is ceed 48 hours post-parturition. Milk quickly destroyed in such containers. taken during treatment and for 48 Medicated drinking water should be hours after the last treatment must prepared daily and be the sole source of not be used for food. Cattle must not be drinking water for 3 consecutive days. slaughtered for food within 48 hours Treatment may be repeated if dys- following last treatment. entery recurs. Do not slaughter treated

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swine for food for at least 3 days fol- 0.5 mg per pound of body weight per lowing treatment. day; (ii) For swine dysentery: Gentamicin [48 FR 10302, Mar. 11, 1983. Redesignated at 49 sulfate equivalent to 50 mg of FR 572, Jan. 5, 1984, and amended at 49 FR 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] body weight per day. Treatment may be repeated if dysentery recurs. § 520.1044b Gentamicin sulfate pig (2) Indications for use. For control and pump oral solution. 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 000859 hyodysenteriae. in § 510.600(c) of this chapter. (3) Limitations. For use in swine (c) Related tolerances. See § 556.300 of drinking water only. Do not store or this chapter. offer medicated drinking water in rusty containers since the drug is (d) Conditions of use—(1) Amount. Ad- quickly destroyed in such containers. minister 1.15 milliliters of pig pump Medicated drinking water should be oral solution (5 milligrams of prepared daily and be the sole source of gentamicin) orally per pig one time. drinking water. (2) Indications for use. In neonatal (4) Withdrawal period. 10 days. swine 1 to 3 days of age for control and treatment of colibacillosis caused by [77 FR 4226, Jan. 27, 2012] strains of E. coli sensitive to gentamicin. § 520.1100 Griseofulvin. (3) Limitations. For use in neonatal (a) Specifications—(1) The powder swine only. Do not slaughter treated complies with U.S.P. for griseofulvin, swine for food for at least 14 days fol- microsize. lowing treatment. (2) Each bolus contains 2.5 grams griseofulvin. [49 FR 572, Jan. 5, 1984, as amended at 52 FR (3) Each tablet contains 125 or 500 7832, Mar. 13, 1987; 62 FR 29011, May 29, 1997; milligrams griseofulvin. 78 FR 17596, Mar. 22, 2013] (b) Sponsors. See sponsors in § 520.1044c Gentamicin sulfate powder. § 510.600(c) of this chapter. (1) No. 000061 for use of products de- (a) Specifications. Each gram of pow- scribed in paragraph (a) for use as in der contains gentamicin sulfate equiv- paragraph (d) of this section. alent to: (2) No. 061623 for use of the powder de- (1) 16.7, 66.7, or 333.3 milligrams (mg) scribed in paragraph (a)(1) for use as in gentamicin. paragraphs (d)(1)(i)(A) and (d)(1)(ii) of (2) 333.3 mg gentamicin. this section. (b) Sponsors. See sponsors in (c) Special considerations. Federal law § 510.600(c) of this chapter for use as in restricts this drug to use by or on the paragraph (d) of this section as follows: order of a licensed veterinarian. (1) No. 000061 for products described (d) Conditions of use—(1) Horses—(i) in paragraph (a)(1) of this section. Amount and indications for use—(A) For (2) Nos. 057561 and 061623 for product equine ringworm infection caused by described in paragraph (a)(2) of this Trichophyton equinum or Microsporum section. gypseum, administer soluble powder de- (c) Related tolerances. See § 556.300 of scribed in paragraph (a)(1) of this sec- this chapter. tion daily as a drench or as a top dress- (d) Conditions of use in swine—(1) ing on feed for not less than 10 days as Amount. Administer in drinking water follows: adults, 2.5 grams; yearlings, for 3 consecutive days as follows: 1.25 to 2.5 grams; and foals, 1.25 grams. (i) For colibacillosis: Gentamicin sul- (B) For treating ringworm infection fate equivalent to 25 mg of gentamicin caused by T. equinum, administer per gallon of drinking water to provide boluses described in paragraph (a)(2) of

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this section daily for not less than 10 (e) Related tolerances. See § 556.310 of days as follows: adults, 1 bolus; year- this chapter. lings, one-half to 1 bolus; and foals, (f) Conditions of use. It is used as a one-half bolus. drench as follows: (ii) Limitations. Not for use in horses (1) Cattle—(i) Amount. 141.5 grams per intended for food. packet. (2) Dogs and cats: (i) Amount. 125- and (ii) Indications for use. Control of gas- 500-milligram tablets administered trointestinal roundworms of the genera orally as follows: Haemonchus, Ostertagia, (A) Daily (single or divided) dose: Trichostrongylus, and Cooperia. (iii) Limitations. (a) Dissolve each Dosage Body weight (pounds) (milli- packet in 32 fluid ounces of water and grams) administer as follows:

Up to 6 ...... 62.5 Dose (fluid 6 to 18 ...... 125 Weight of animal (pounds) ounces) 18 to 36 ...... 250 36 to 48 ...... 375 Up to 100 ...... 1⁄2 48 to 75 ...... 500 100 to 150 ...... 3⁄4 150 to 200 ...... 1 (B) Weekly (single) dose: If experi- 200 to 300 ...... 11⁄2 300 to 450 ...... 2 ence indicates that treatment is more 450 to 700 ...... 3 effective for the drug given in large 700 to 1,000 ...... 4 doses, administer at intervals of 7 to 10 1,000 to 1,200 ...... 5 days, a dose equal to 10 milligrams/ Over 1,200 ...... 6 pound of body weight × body weight × number of days between treatments. (b) Do not treat within 1 week of Dosage should be adjusted according to slaughter; do not treat dairy animals response. Administer additional dose of breeding age; animals should be re- after the animal is free of infection. treated in 3 to 4 weeks. (ii) Indications for use. For treatment [40 FR 13838, Mar. 27, 1975, as amended at 45 of fungal infections of the skin, hair, FR 10333, Feb. 15, 1980; 46 FR 48642, Oct. 2, and claws caused by Trichophyton 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, mentagrophytes, T. rubrum, T. Nov. 19, 1997] schoenleini, T. sulphurem, T. verrucosum, § 520.1120b Haloxon boluses. T. interdigitale, Epidermophyton floccosum, Microsporum gypseum, M. (a) Chemical name. 3-Chloro-7-hy- canis, M. audouini. droxy-4-methylcoumarin bis (2- chloroethyl) phosphate. [40 FR 13838, Mar. 27, 1975, as amended at 41 (b) Specifications. Each bolus contains FR 42948, Sept. 29, 1976; 43 FR 28458, June 30, 1978; 52 FR 7832, Mar. 13, 1987; 54 FR 30205, 10.1 grams of haloxon. July 19, 1989; 71 FR 38073, July 5, 2006; 77 FR (c) Sponsor. See No. 000061 in 28253, May 14, 2012] § 510.600(c) of this chapter. (d) Related tolerances. See § 556.310 of § 520.1120 Haloxon oral dosage forms. this chapter. (e) Conditions of use. (1) Haloxon bolus § 520.1120a Haloxon drench. is an anthelmintic used in cattle for (a) Chemical name. 3-Choloro-7- the control of gastrointestinal hydoxy-4-methylcoumarin bis (2- roundworms of the genera Haemonchus, chloroethyl) phosphate. Ostertagia, Trichostrongylus and (b) Specifications. Haloxon assay of Cooperia. not less than 96 percent by infrared (2) It is administered by giving one spectrum at 8.62 microns. bolus per approximately 500 pounds (c) Sponsor. See No. 000061 in body weight (35 to 50 milligrams per § 510.600(c) of this chapter. kilogram of body weight). (d) Special considerations. Do not use (3) For most effective results, re- any drug, insecticide, pesticide, or treat animals in 3 to 4 weeks. If rein- other chemical having cholinesterase- fection is likely to occur, additional re- inhibiting activity either simulta- treatments may be necessary. neously or within a few days before or (4) Do not use any drug, pesticide or after treatment with haloxon. other chemical having cholinesterase

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inhibiting activity either simulta- of the skin surface, loss of hair, sebor- neously or within a few days before or rhea, thickening of the skin, after treatment with haloxon. hyperpigmentation, and lethargy. (5) Do not treat animals within one (3) Limitations. If no response is ob- week of slaughter. served in 30 to 45 days, the drug should (6) Do not treat dairy animals of be withdrawn and the diagnosis recon- breeding age or older. sidered. Do not use in the presence of [40 FR 13838, Mar. 27, 1975, as amended at 44 cardiac disease, ischemia, adrenal in- FR 61591, Oct. 29, 1979; 46 FR 48642, Oct. 2, sufficiency, or nephrosis. Federal law 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, restricts this drug to use by or on the Nov. 19, 1997] order of a licensed veterinarian. § 520.1130 Hetacillin. [49 FR 22469, May 30, 1984] (a) Specifications.—(1) Each capsule or § 520.1158 Iodochlorhydroxyquin tablet contains hetacillin potassium boluses. equivalent to 50, 100, or 200 milligrams (mg) of ampicillin. (a) Specifications. Each bolus contains (2) Each milliliter of suspension con- 10 grams of iodochlorhydroxyquin. tains hetacillin potassium equivalent (b) Sponsor. See No. 053501 in to 50 mg of ampicillin. § 510.600(c) of this chapter. (b) Sponsor. See No. 000010 in (c) Conditions of use—(1) Amount. 1 § 510.600(c) of this chapter. bolus (10 grams) daily for a 1,000-pound (c) Conditions of use in dogs and cats— horse. (1) Amount—(i) Dogs. Administer 5 mg (2) Indications for use. For treatment per pound (/lb) of body weight orally, of equine diarrhea. twice daily. In severe infections, ad- (3) Limitations. For horses only; not minister 5 mg/lb three times daily, or to be administered to food-producing up to 10 mg/lb twice daily. For stub- animals. Do not administer to horses born urinary tract infections, admin- intended for use as food. Federal law ister up to 20 mg/lb twice daily. restricts this drug to use by or on the (ii) Cats. Administer 50 mg twice order of a licensed veterinarian. daily. (2) Indications for use. For the treat- [48 FR 8054, Feb. 25, 1983, as amended at 50 ment of respiratory tract infections, FR 41489, Oct. 11, 1985] urinary tract infections, gastrointestinal infections, skin infections, § 520.1182 Iron dextran suspension. soft tissue infections, and postsurgical (a) Specifications. Each milliliter infections associated with strains of or- (mL) of suspension contains 55.56 milli- ganisms susceptible to hetacillin po- grams (mg) iron as ferric hydroxide in tassium. complex with a low molecular weight (3) Limitations. Federal law restricts dextran. this drug to use only by or on the order (b) Sponsor. See No. 051311 in of a licensed veterinarian. § 510.600(c) of this chapter. [75 FR 10166, Mar. 5, 2010] (c) Conditions of use in swine—(1) Amount. Administer 100 mg (1.8 mL) § 520.1157 Iodinated casein tablets. orally by automatic dose dispenser. (a) Specifications. Each 1-gram tablet (2) Indications for use. For the preven- contains 25 milligrams of iodinated cation of iron deficiency anemia in baby sein. pigs. (b) Sponsor. See No. 017762 in (3) Limitations. Treat each pig within § 510.600(c) of this chapter. 24 hours of farrowing. (c) Conditions of use—(1) Amount. 1⁄5 to 1 tablet per 10 pounds of body weight [70 FR 32489, June 3, 2005] (equivalent to 0.5 to 2.5 milligrams of iodinated casein per pound of body § 520.1192 Ivermectin paste. weight). (a) Specifications. Each milligram (2) Indications for use. For dogs for ap- (mg) of paste contains 0.0187 mg (1.87 parent decreased thyroid activity percent) or 0.00153 mg (0.153 percent) of where the signs are alopecia, scaliness ivermectin.

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(b) Sponsors. See sponsors in (iii) Limitations. For oral use only. Do § 510.600(c) of this chapter for use as in not use in horses intended for human paragraph (e) of this section: consumption. (1) No. 050604 for use of a 1.87 percent (2) Cattle—(i) Amount. 23 milligrams paste as in (e)(1) of this section and a per 250 pounds of body weight. 0.153 percent paste for use as in para- (ii) Indications for use. It is used in graph (e)(2) of this section. cattle for the treatment and control of gastrointestinal roundworms (adults (2) Nos. 000859, 051311, 054925, and and fourth-stage larvae) (Ostertagia 061623 for use of a 1.87 percent paste for ostertagi (including inhibited forms), O. use as in paragraph (e)(1) of this sec- lyrata, Haemonchus placei, tion. Trichostrongylus axei, T. colubriformis, (c) Related tolerances. See § 556.344 of Cooperia oncophora, C. punctata, this chapter. Nematodirus helvetianus, Bunostomum (d) Special considerations. See § 500.25 phlebotomum, Strongyloides papillosus of this chapter. (adults only), Oesophagostomum (e) Conditions of use—(1) Horses—(i) radiatum, Trichuris ovis (adults only)); Amount. 200 micrograms per kilogram lungworms (adults and fourth-stage (91 micrograms per pound) of body larvae) (Dictyocaulus viviparus); grubs weight. (first, second, and third instars) (ii) Indications for use. For treatment (Hypoderma bovis, H. lineatum); and and control of Large Strongyles sucking lice (Linognathus vituli, (adults): Strongylus vulgaris (also early Haematopinus eurysternus). forms in blood vessels), S. edentatus (iii) Limitations. For oral use only. Do (also tissue stages), S. equinus, not treat cattle within 24 days of slaughter. Because withdrawal time in Triodontophorus spp. including T. milk has not been established, do not brevicauda and T. serratus, and use in female dairy cattle of breeding Craterostomum acuticaudatum; Small age. Strongyles (adults, including those resistant to some benzimidazole class [49 FR 22275, May 29, 1984, as amended at 50 compounds): Coronocyclus spp. includ- FR 27819, July 8, 1985; 51 FR 44449, Dec. 10, 1986; 53 FR 51273, Dec. 21, 1988; 62 FR 63270, ing C. coronatus, C. labiatus, and C. Nov. 28, 1997; 65 FR 70661, Nov. 27, 2000; 67 FR labratus, Cyathostomum spp. including 71820, Dec. 3, 2002; 68 FR 43294, July 22, 2003; C. catinatum and C. pateratum, 69 FR 59131, Oct. 4, 2004; 70 FR 8514, Feb. 22, Cylicocyclus spp. including C. insigne, C. 2005; 71 FR 40010, July 14, 2006; 71 FR 67298, leptostomum, C. nassatus, and C. Nov. 21, 2006; 73 FR 34184, June 17, 2008; 74 FR brevicapsulatus, Cylicodontophorus spp., 6542, Feb. 10, 2009; 78 FR 17596, Mar. 22, 2013] Cylicostephanus spp. including C. § 520.1193 Ivermectin tablets and calicatus, C. goldi, C. longibursatus, and chewables. C. minutus, and Petrovinema poculatum; (a) Specifications. (1) Each tablet or Small Strongyles (fourth-stage larvae); chewable contains 68, 136, or 272 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 059130 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. order of a licensed veterinarian.

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(d) Conditions of use—(1) Dogs. For use sistant to some benzimidazole class in dogs 6 weeks of age and older as fol- compounds): Coronocyclus spp. includ- lows: ing C. coronatus, C. labiatus, and C. (i) Amount. 6.0 mcg per kilogram (kg) labratus, Cyathostomum spp. including of body weight (2.72 mcg per pound C. catinatum and C. pateratum, (lb)), minimum. Up to 25 lb, 68 mcg; 26 Cylicocyclus spp. including C. insigne, C. to 50 lb, 136 mcg; 51 to 100 lb, 272 mcg; leptostomum, C. nassatus, and C. over 100 lb, a combination of the appro- brevicapsulatus, Cylicodontophorus spp., priate tablets. Administer at monthly Cylicostephanus spp. including C. dosing intervals. calicatus, C. goldi, C. longibursatus, and (ii) Indications for use. To prevent ca- C. minutus, and Petrovinema poculatum; nine heartworm disease by eliminating Small Strongyles (fourth-stage larvae); the tissue stage of heartworm larvae Pinworms (adults and fourth stage lar- (Dirofilaria immitis) for 1 month (30 vae): Oxyuris equi; Ascarids (adults and days) after infection. third- and fourth-stage larvae): (2) Cats. For use in cats 6 weeks of Parascaris equorum; Hairworms (adults): age and older as follows: Trichostrongylus axei; Large Mouth (i) Amount. Up to 2.3 kilograms (up to Stomach Worms (adults): Habronema 5 lb), 55 mcg; 2.3 to 6.8 kilograms (5 to muscae; Bots (oral and gastric stages): 15 lb), 165 mcg; over 6.8 kilograms (15 Gasterophilus spp. including G. lb), a combination of the appropriate intestinalis and G. nasalis; Lungworms chewables (recommended minimum (adults and fourth-stage larvae): dose of 24 mcg/kg of body weight (10.9 Dictyocaulus arnfieldi; Intestinal mcg/lb)). Administer once a month. Threadworms (adults): Strongyloides (ii) Indications for use. To prevent fe- westeri; Summer Sores caused by line heartworm disease by eliminating Habronema and Draschia spp. cutaneous the tissue stage of heartworm larvae third-stage larvae; Dermatitis caused Dirofilaria immitis for a month (30 days) by neck threadworm microfilariae, after infection, and for removal and Onchocerca sp. control of adult and immature (L4) Limitations. Do not use in horses in- hookworms Ancylostoma tubaeforme and tended for human consumption. A. braziliense. [70 FR 1817, Jan. 11, 2005, as amended at 70 [67 FR 11230, Mar. 13, 2002, as amended at 67 FR 19262, Apr. 13, 2005] FR 21996, May 2, 2002; 69 FR 43735, July 22, 2004] § 520.1195 Ivermectin liquid. § 520.1194 Ivermectin meal. (a) Specifications—(1) Each milliliter (a) Specifications. Each gram of meal (mL) contains 10 milligrams (mg) contains 6 milligrams ivermectin (0.6 ivermectin. percent). (2) Each mL of micellar solution con- (b) Sponsor. See No. 017135 in tains 0.8 mg ivermectin. § 510.600(c) of this chapter. (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.

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(d) Special considerations. See § 500.25 (Trichostongylus axei(adult)); Large of this chapter. mouth Stomach Worms (Habronema (e) Conditions of use—(1) Horses—(i) muscae (adult)); Stomach Bots Amount. 200 micrograms (mcg) per kilo- (Gastrophilus spp. (oral and gastric gram (/kg) of body weight as a single stages)); Lungworms (Dictyocaulus dose by stomach tube or as an oral arnfieldi (adult and fourth-stage lar- drench. vae)); intestinal threadworms (ii) Indications for use. For treatment (Strongyloides westeri (adult)); Summer and control of: Sores caused by Habronema and (A) Large Strongyles (adults): Draschia spp. cutaneous third-stage lar- Strongylus vulgaris (also early forms in vae; and Dermatitis caused by neck blood vessels), S. edentatus (also tissue threadworm microfilariae (Onchocerca stages), S. equinus, Triodontophorus spp. spp.). including T. brevicauda and T. serratus, (iii) Limitations. Do not use in horses and Craterostomum acuticaudatum; intended for human consumption. Fed- Small Strongyles (adults, including eral law restricts this drug to use by or those resistant to some benzimidazole on the order of a licensed veterinarian. class compounds): Coronocyclus spp. in- (2) Sheep—(i) Amount. 200 mcg/kg (3 cluding C. coronatus, C. labiatus, and C. mL/26 pounds) of body weight as a sin- labratus, Cyathostomum spp. including gle dose oral drench. C. catinatum and C. pateratum, (ii) Indications for use. For treatment Cylicocyclus spp. including C. insigne, C. and control of the adult and fourth- leptostomum, C. nassatus, and C. stage larvae of gastrointestinal brevicapsulatus, Cylicodontophorus spp., roundworms (Haemonchus contortus, H. Cylicostephanus spp. including C. placei (adults only), Ostertagia calicatus, C. goldi, C. longibursatus, and circumcincta, Trichostrongylus axei, T. C. minutus, and Petrovinema poculatum; colubriformis, Cooperia oncophora Small Strongyles (fourth-stage larvae); (adults only), C. curticei, Pinworms (adults and fourth stage lar- Oesophagostomum columbianum, O. vae): Oxyuris equi; Ascarids (adults and venulosum(adults only), Nematodirus third- and fourth-stage larvae): battus, N. spathiger, S. papillosus (adults Parascaris equorum; Hairworms (adults): only), Chabertia ovina (adult only), Trichostrongylus axei; Large mouth Trichuris ovis (adults only)); lungworms Stomach Worms (adults): Habronema (D. filaria); and all larval stages of the muscae; Bots (oral and gastric stages): nasal bot Oestrus ovis. 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), pamoate chewable 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. A minimum of 6 μg of

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ivermectin and 5 mg of pyrantel (as calves weighing less than 275 lb (125 pamoate salt) per kilogram (2.72 μg and kg). Do not administer a damaged 2.27 mg per pound) of body weight. bolus. Because a milk withdrawal time (ii) Indications for use. To prevent ca- has not been established, do not use in nine heartworm disease by eliminating female dairy cattle of breeding age. Do the tissue larval stages of Dirofilaria not slaughter cattle within 180 days of immitis for up to a month (30 days) after treatment. Consult your veterinarian infection and treatment and control of for assistance in the diagnosis, treat- adult ascarids Toxocara canis and ment, and control of parasitism. Toxascaris leonina, and adult [61 FR 67452, Dec. 23, 1996, as amended at 62 hookworms Ancylostoma caninum, A. FR 63270, Nov. 28, 1997; 65 FR 45876, July 26, braziliense, and Uncinaria stenocephala. 2000] (iii) Limitations. Use monthly. Rec- ommended for dogs 6 weeks of age and § 520.1198 Ivermectin and praziquantel older. Federal law restricts this drug to paste. use by or on the order of a licensed vet- (a) Specifications. Each milligram erinarian. (mg) of paste contains: (2) [Reserved] (1) 0.0155 mg (1.55 percent) ivermectin [58 FR 8542, Feb. 16, 1993, as amended at 61 and 0.0775 mg (7.75 percent) FR 15186, Apr. 5, 1996; 61 FR 59004, Nov. 20, praziquantel. 1996; 62 FR 63270, Nov. 28, 1997; 66 FR 35756, (2) 0.0187 mg (1.87 percent) ivermectin July 9, 2001; 67 FR 21996, May 2, 2002; 68 FR and 0.1403 mg (14.03 percent) 55823, Sept. 29, 2003] praziquantel. (b) Sponsors. See sponsors in § 520.1197 Ivermectin sustained-re- § 510.600(c) of this chapter for uses as in lease bolus. paragraph (d) of this section.— (a) Specifications. Each sustained-re- (1) No. 050604 for use of product de- lease bolus contains 1.72 grams of scribed in paragraph (a)(1) of this sec- ivermectin. tion as in paragraphs (d)(1)(i), (d)(2)(i) (b) Sponsor. See No. 050604 in and (d)(3) of this section. § 510.600(c) of this chapter. (2) No. 051311 for use of product de- (c) Related tolerances. See § 556.344 of scribed in paragraph (a)(2) of this sec- this chapter. tion as in paragraphs (d)(1)(ii), (d) Conditions of use in ruminating (d)(2)(ii), and (d)(3) of this section. calves—(1) Amount. Administer one (c) Special considerations. See § 500.25 bolus per calf weighing at least 275 of this chapter. pounds (lb) (125 kilograms (kg)) and not (d) Conditions of use in horses—(1) more than 660 lb (300 kg) on the day of Amount—(i) 200 micrograms (mcg) per administration. kilogram (/kg) ivermectin (91 mcg per (2) Indications. For treatment and pound (/lb)) and 1 mg/kg praziquantel control, throughout the grazing season (454 mcg/lb) body weight. (approximately 130 days), of gastro- (ii) 200 mcg/kg ivermectin (91 mcg/lb) intestinal roundworms Haemonchus and 1.5 mg/kg praziquantel (681 mcg/lb) placei, Ostertagia ostertagi (including in- body weight. hibited fourth-stage larvae), (2) Indications for use. For treatment Trichostrongylus axei, T. colubriformis, and control of: Cooperia spp., Nematodirus helvetianus, (i) Tapeworms—Anoplocephala Bunostomum phlebotomum, perfoliata; Large strongyles (adults)— Oesophagostomum radiatum; lungworms Strongylus vulgaris (also early forms in Dictyocaulus viviparus; grubs Hypoderma blood vessels), S. edentatus (also tissue spp.; sucking lice Linognathus vituli, stages), S. equinus, Triodontophorus spp. Solenopotes capillatus; mange mites including T. brevicauda and T. serratus, Psoroptes ovis, Sarcoptes scabiei, and and Craterostomum acuticaudatum; ticks Amblyomma americanum. Small Strongyles (adults, including (3) Limitations. The bolus was specifi- those resistant to some benzimidazole cally designed for use in cattle; do not class compounds)—Coronocyclus spp. in- use in other animal species. Calves cluding C. coronatus, C. labiatus, and C. must be ruminating and older than 12 labratus, Cyathostomum spp. including weeks of age. Do not administer to C. catinatum and C. pateratum,

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Cylicocyclus spp. including C. insigne, C. § 520.1199 Ivermectin, pyrantel, and leptostomum, C. nassatus, and C. praziquantel tablets. brevicapsulatus, Cylicodontophorus spp., (a) Specifications. Each chewable tab- Cylicostephanus spp. including C. let contains: calicatus, C. goldi, C. longibursatus, and (1) 34 micrograms (mcg) ivermectin, C. minutus, and Petrovinema poculatum; 28.5 milligrams (mg) pyrantel pamoate, Small Strongyles—fourth-stage larvae; and 28.5 mg praziquantel; Pinworms (adults and fourth-stage lar- (2) 68 mcg ivermectin, 57 mg pyrantel vae)—Oxyuris equi; Ascarids (adults and pamoate, and 57 mg praziquantel; third- and fourth-stage larvae)— (3) 136 mcg ivermectin, 114 mg Parascaris equorum; Hairworms pyrantel pamoate, and 114 mg (adults)—Trichostrongylus axei; Large- praziquantel; or mouth Stomach Worms (adults)— (4) 272 mcg ivermectin, 228 mg Habronema muscae; Bots (oral and gas- pyrantel pamoate, and 228 mg tric stages)—Gasterophilus spp. includ- praziquantel. ing G. intestinalis and G. nasalis; (b) Sponsors. See No. 051311 in Lungworms (adults and fourth-stage § 510.600(c) of this chapter. larvae)—Dictyocaulus arnfieldi; Intes- (c) Conditions of use in dogs—(1) tinal Threadworms (adults)— Amount. Administer monthly according Strongyloides westeri; Summer Sores to body weight as follows: caused by Habronema and Draschia spp. (i) 6 to 12 lb: one tablet as described cutaneous third-stage larvae; Derma- in paragraph (a)(1) of this section. titis caused by neck threadworm (ii) 12.1 to 25 lb: one tablet as de- microfilariae, Onchocerca sp. scribed in paragraph (a)(2) of this sec- (ii) Tapeworms—Anoplocephala tion. perfoliata; Large Strongyles (adults)— (iii) 25.1 to 50 lb: one tablet as described in paragraph (a)(3) of this sec- Strongylus vulgaris (also early forms in tion. blood vessels), S.edentatus (also tissue (iv) 50.1 to 100 lb: one tablet as de- stages), S. equinus, Triodontophorus scribed in paragraph (a)(4) of this sec- spp.; Small Strongyles (adults, includ- tion. ing those resistant to some benzimid- (v) Greater than 100 lb: use the appro- azole class compounds)—Cyathostomum priate combination of tablets. spp., Cylicocyclus spp., Cylicostephanus (2) Indications for use. Prevents ca- spp., Cylicodontophorus spp.; Small nine heartworm disease by eliminating Strongyles—fourth-stage larvae; the tissue stage of heartworm larvae Pinworms (adults and fourth-stage lar- (Dirofilaria immitis) for 1 month (30 vae)—Oxyuris equi; Ascarids (adults and days) after infection and for the treat- third- and fourth-stage larvae)— ment and control of roundworm Parascaris equorum; Hairworms (Toxocara canis, Toxascaris leonina), (adults)—Trichostrongylus axei; Large- hookworm (Ancylostoma caninum, mouth Stomach Worms (adults)— Uncinaria stenocephala, Ancylostoma Habronema muscae; Bots (oral and gas- braziliense) and tapeworm (Dipylidium tric stages)—Gasterophilus spp.; caninum, Taenia pisiformis) infections. Lungworms (adults and fourth-stage (3) Limitations. Federal law restricts larvae)—Dictyocaulus arnfieldi; Intes- this drug to use by or on the order of a tinal Threadworms (adults)— licensed veterinarian. Strongyloides westeri; Summer Sores [71 FR 65052, Nov. 7, 2006] caused by Habronema and Draschia spp. cutaneous third-stage larvae; Derma- § 520.1200 Ivermectin, fenbendazole, titis caused by neck threadworm and praziquantel tablets. microfilariae, Onchocerca sp. (a) Specifications. Each chewable tab- (3) Limitations. For oral use only. Do let contains either: not use in horses intended for human (1) 68 micrograms (μg) ivermectin, consumption. 1.134 grams fenbendazole, and 57 milli- [68 FR 55309, Sept. 25, 2003, as amended at 69 grams (mg) praziquantel; or FR 49808, Aug. 12, 2004; 70 FR 65835, Nov. 1, (2) 27 μg ivermectin, 454 mg 2005] fenbendazole, and 23 mg praziquantel.

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(b) Sponsor. See No. 000061 in § 520.1242 Levamisole. § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) § 520.1242a Levamisole powder. Amount. Administer tablets to provide (a) Specifications. Each package of 6 μg per kilogram (/kg) ivermectin, 100 powder contains 9.075, 11.7, 18.15, 46.8, mg/kg fenbendazole, and 5 mg/kg 362.7, or 544.5 grams (g) levamisole hy- praziquantel. drochloride. (2) Indications for use. For the treat- (b) Sponsors. See sponsors in ment and control of adult Toxocara § 510.600(c) for use as follows: canis (roundworm), Ancylostoma (1) No. 000061 for use of 46.8- and 544.5- caninum (hookworm), Trichuris vulpis g packages as in paragraph (e)(1)(i), (whipworm), and Dipylidium caninum (e)(1)(ii)(B), and (e)(1)(iii) of this section; 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. 053501 for use of a 46.8-g pack- licensed veterinarian. age as in paragraph (e)(1)(i), [73 FR 33692, June 13, 2008, as amended at 74 (e)(1)(ii)(A), and (e)(1)(iii) of this sec- FR 61516, Nov. 25, 2009] tion; for 11.7- and 46.8-g packages as in 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 (a) Specifications—(1) Each 5 milli- (e)(3) of this section. liters (mL) of suspension contains 100 (3) No. 057561 for use of 46.8- and 544.5- g packages as in paragraphs (e)(1)(i), milligrams (mg) kanamycin (as the (e)(1)(ii)(A), and (e)(1)(iii) and (e)(2)(i), sulfate), 250 mg bismuth subcarbonate, (e)(2)(ii)(A), and (e)(2)(iii) of this sec- and 500 mg activated attapulgite (alu- tion. minum magnesium silicate). (4) No. 059130 for use of 46.8-, 362.7-, (2) Each tablet contains 100 mg and 544.5-g packages as in paragraphs kanamycin (as the sulfate), 250 mg bis- (e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i), muth subcarbonate, and 500 mg acti- (e)(2)(ii)(B), and (e)(2)(iii) of this sec- vated attapulgite. tion; and for use of an 18.15-g package (b) Sponsor. See No. 000856 in as in paragraph (e)(3) of this section. § 510.600(c) of this chapter. (c) Related tolerances. See § 556.350 of (c) Conditions of use in dogs—(1) this chapter. Amount. 5 mL of suspension or 1 tablet (d) Special considerations. See § 500.25 per 20 pounds body weight every 8 of this chapter. hours. Maximum dose: 5 mL of suspen- (e) Conditions of use. It is used as an sion or 3 tablets every 8 hours. Dogs anthelmintic as follows: under 10 pounds: 2.5 mL of suspension (1) Cattle—(i) Amount. 8 milligrams or 1⁄2 tablet every 8 hours. A rec- per kilogram (mg/kg) body weight as a ommended initial loading dose should drench. be twice the amount of a single dose. (ii) Indications for use—(A) Effective (2) Indications for use. For the treat- against the following nematode infec- ment of bacterial enteritis caused by tions: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia); intestinal organisms susceptible to kanamycin worms (Trichostrongylus, Cooperia, and the symptomatic relief of the asso- Nematodirus, Bunostomum, ciated diarrhea. Oesophagostomum); and lungworms (3) Limitations. Federal law restricts (Dictyocaulus). this drug to use by or on the order of a (B) Effective against the following licensed veterinarian. adult nematode infections: Stomach [40 FR 13838, Mar. 27, 1975, as amended at 53 worms (Haemonchus placei, Ostertagia FR 27851, July 25, 1988; 56 FR 8710, Mar. 1, ostertagi, Trichostrongylus axei); intes- 1991; 64 FR 403, Jan. 5, 1999; 71 FR 43968, Aug. tinal worms (T. longispicularis, Cooperia 3, 2006] oncophora, C. punctata, Nematodirus

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spathiger, Bunostomum phlebotomum, § 520.1242b Levamisole hydrochloride Oesophagostomum radiatum); and tablet or oblet (bolus). lungworms (Dictyocaulus viviparus). (a) Chemical name. (-)-2,3,5,6- (iii) Limitations. Do not slaughter for Tetrahydro-6-phenylimidazo [2,1-b] thi- food within 48 hours of treatment. Not azole monohydrochloride. for use in dairy animals of breeding (b) Specifications. Assay of not less age. Conditions of constant helminth than 98 percent by nonaqueous titra- exposure may require retreatment 2 to tion with 0.1 N potassium isopropoxide; 4 weeks after the first treatment. Con- 1 isomer minimum 95 percent pure by sult your veterinarian before using in optical rotation. severely debilitated animals. (c) Sponsor. See Nos. 000061 and 053501 (2) Sheep—(i) Amount. 8 mg/kg body in § 510.600(c) of this chapter. weight as a drench. (d) Required labeling. Consult your (ii) Indications for use—(A) Effective veterinarian for assistance in the diag- against the following nematode infec- nosis, treatment, and control of para- tions: Stomach worms (Haemonchus, sitism. Trichostrongylus, Ostertagia); intestinal (e) Related tolerances. See § 556.350 of worms (Trichostrongylus, Cooperia, this chapter. Nematodirus, Bunostomum, (f) Conditions of use. (1) It is used in Oesophagostomum, Chabertia); and an oblet for cattle as follows: lungworms (Dictyocaulus). (i) Amount. 2.19 grams per oblet. (B) Effective against the following (ii) Indications for use. Anthelmintic adult nematode infections: Stomach effective against the following nema- worms (Haemonchus contortus, tode infections: Stomach worms Trichostrongylus axei, Teladorsagia (Haemonchus, Trichostrongylus, circumcincta); intestinal worms Ostertagia), intestinal worms (Trichostrongylus colubriformis, Cooperia (Trichostrongylus, Cooperia, curticei, Nematodirus spathiger, Nematodirus, Bunostomum, Bunostomum trigonocephalum, Oesophagostomum), and lungworms Oesophagostomum columbianum, (Dictyocaulus). Chabertia ovina), and lungworms (iii) Limitations. Administer as a sin- (Dictyocaulus filaria). gle dose as follows: 250 to 450 pounds, 1⁄2 (iii) Limitations. Do not slaughter for oblet; 450 to 750 pounds, 1 oblet; and 750 food within 72 hours of treatment. Con- to 1,050 pounds, 11⁄2 oblets; conditions of ditions of constant helminth exposure constant helminth exposure may re- may require retreatment 2 to 4 weeks quire re-treatment within 2 to 4 weeks after the first treatment. Consult vet- after the first treatment; do not erinarian before using in severely de- slaughter for food within 48 hours of bilitated animals. treatment; not for use in dairy animals (3) Swine—(i) Amount. 8 mg/kg body of breeding age; consult veterinarian weight in drinking water. before using in severely debilitated (ii) Indications for use. Effective animals. against the following nematode infec- (2) It is used in a tablet for sheep as tions: Large roundworms (Ascaris follows: suum), nodular worms (i) Amount. 0.184 gram per tablet. (Oesophagostomum spp.), intestinal (ii) Indications for use. Anthelmintic thread worms (Strongyloides ransomi) effective against the following nema- and lungworms (Metastrongylus spp. ). tode infections: Stomach worms (iii) Limitations. Do not administer (Haemonchus, Trichostrongylus, within 72 hours of slaughter for food. Ostertagia), intestinal worms Pigs maintained under conditions of (Trichostrongylus, Cooperia, constant exposure to worms may re- Nematodirus, Bunostomum, quire retreatment within 4 to 5 weeks Oesophagostomum, Chabertia), and after the first treatment. Consult your lungworms (Dictyocaulus). veterinarian before administering to (iii) Limitations. Administer one tab- sick swine. let for each 50 pounds of body weight; [69 FR 9753, Mar. 2, 2004, as amended at 69 FR conditions of constant helminth expo- 33839, June 17, 2004; 70 FR 2353, Jan. 13, 2005; sure may require re-treatment within 2 77 FR 28253, May 14, 2012] to 4 weeks after the first treatment; do

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not slaughter for food within 72 hours (b) Sponsor. See No. 043781 in of treatment; consult a veterinarian § 510.600(c) of this chapter. before using in severely debilitated (c) Related tolerances. See § 556.350 of animals. this chapter. [40 FR 13838, Mar. 27, 1975, as amended at 44 (d) Conditions of use. In swine it is FR 59507, Oct. 16, 1979; 62 FR 61625, Nov. 19, used as follows: 1997; 67 FR 63055, Oct. 10, 2002] (1) Amount. The equivalent of 8 milligrams per kilogram of body weight, as § 520.1242c Levamisole hydrochloride a single dose, mixed in the animal’s ra- and piperazine dihydrochloride. tion. (a) Specifications. (1) The drug is an (2) Indications for use. For the re- aqueous solution which contains in moval of and control of the following each fluid ounce 0.36 gram of nematode infections: large roundworms levamisole hydrochloride and piper- (Ascaris suum), nodular worms azine dihydrochloride equivalent to 3.98 (Oesophagostomum spp.), lungworms grams of piperazine base. (Metastrongylus spp.), intestinal (2) The drug is a soluble powder threadworms (Strongyloides ransomi), which when reconstituted with water and swine kidney worms (Stephanurus contains in each fluid ounce 0.45 gram dentatum). of levamisole hydrochloride and piper- (3) Limitations. For pigs from weaning azine dihydrochloride equivalent to 5.0 to market weight, mix one 58.1-gram grams of piperazine base. packet of levamisole resinate con- (b) Sponsor. See No. 053501 in taining the equivalent of 10-percent § 510.600(c) of this chapter. levamisole hydrochloride in 40 pounds (c) [Reserved] of feed and administer 1 pound of medi- (d) Conditions of use. It is used as a cated feed per 40 pounds of body weight drench for horses as follows: as sole ration. For breeding swine, mix (1) Indications for use. An anthel- 1 packet of the 10-percent resinate in 16 mintic effective against infections of pounds of feed and administer 1 pound large strongyles (Strongylus vulgaris, S. of medicated feed per 100 pounds of edentatus), small strongyles body weight as sole ration. Administer (Cylicocercus spp., Cylicocylclus spp., as single doses. Withhold regular feed Cylicodontophorus spp., Cylicostephanus overnight and administer medicated spp., Cylicotetrapedon spp. ), ascarids (Parascaris equorum), and pinworms feed the following morning. Do not (Oxyuris equii). withhold water during fasting. Do not (2) Limitations. Aqueous solution: ad- treat within 72 hours of slaughter. Sali- minister by stomach tube or drench 1 vation or muzzle foam may be ob- fluid ounce per 100 pounds of body served. The reaction will disappear a weight. Reconstituted soluble powder: short time after feeding. If pigs are in- administer by stomach tube 1 fluid fected with mature lungworms, ounce per 125 pounds of body weight. If coughing and vomiting may be ob- reinfection occurs, re-treat animals at served. Consult your veterinarian for 6- to 8-week intervals. Do not treat ani- assistance in the diagnosis, treatment, mals intended for food. Federal law re- and control of parasitism. stricts this drug to use by or on the [43 FR 18171, Apr. 28, 1978, as amended at 45 order of a licensed veterinarian. FR 3574, Jan. 18, 1980]

[40 FR 32831, Aug. 5, 1975, as amended at 41 § 520.1242e Levamisole hydrochloride FR 48731, Nov. 5, 1976; 43 FR 11176 Mar. 17, effervescent tablets. 1978; 67 FR 63055, Oct. 10, 2002] (a) Specifications. Each tablet con- § 520.1242d Levamisole resinate. tains 907 milligrams of levamisole hy- (a) Specifications. The drug is drochloride. levamisole adsorbed on a resin, in a (b) Sponsor. See No. 053501 in concentration equivalent to 10 percent § 510.600(c) of this chapter. levamisole hydrochloride. Each 2.05- (c) Related tolerances. See § 556.350 of ounce (58.1 gram) packet contains this chapter. levamisole equivalent to 5.806 grams of (d) Conditions of use. It is used for levamisole hydrochloride. swine as follows:

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(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] [45 FR 6087, Jan. 25, 1980, as amended at 67 § 520.1242g Levamisole resinate and FR 63055, Oct. 10, 2002] famphur paste. § 520.1242f Levamisole hydrochloride (a) Chemical name of famphur. O, O- gel. Dimethyl O-[p-(dimethylsulfamoyl) phenyl] phosphorothioate. (a) Specifications. The drug is a gel (b) Specifications. The drug is a paste containing 11.5 percent levamisole hy- containing 11.6 percent levamisole res- drochloride. inate (50 percent potency) and 23.6 per- (b) Sponsor. See No. 053501 in cent famphur. § 510.600(c) of this chapter. (c) Sponsor. See 000061 in § 510.600(c) of (c) Related tolerances. See § 556.350 of this chapter. this chapter. (d) Special considerations. Do not use (d) Conditions of use—(1) Cattle—(i) any cholinesterase-inhibiting drugs, Amount. Eight milligrams of pesticides, insecticides, or chemicals levamisole hydrochloride per kilogram on cattle simultaneously or within a of body weight, as a single oral dose. few days before or after treatment with (ii) Indications for use. Anthelmintic this product. effective against the following nema- (e) Related tolerances. See § 556.350 of tode infections: Stomach worms this chapter for levamisole and § 556.273 (Haemonchus, Trichostrongylus, of this chapter for famphur. Ostertagia), intestinal worms (f) Conditions of use in cattle—(1) (Trichostrongylus, Cooperia, Amount. 8 milligrams of levamisole hy- Nematodirus, Bunostomum, drochloride (equivalent) and 30 milli- Oesophagostomum), and lungworms grams of famphur activity per kilo- (Dictyocaulus). gram of body weight. (iii) Limitations. Conditions of con- (2) Indications for use. For treatment stant helminth exposure may require of cattle infected with the following re-treatment within 2 to 4 weeks after parasites: Stomach worms the first treatment; do not administer (Haemonchus, Trichostrongylus, to cattle within 6 days of slaughter for Ostertagia), intestinal worms food; do not administer to dairy ani- (Trichostrongylus, Cooperia, mals of breeding age; consult veteri- Nematodirus, Bunostomum, narian before using in severely debili- Oesophagostomum), lungworms tated animals. (Dictyocaulus), cattle grubs

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(Hypoderma), biting lice (Bovicola), and (1) No. 000009 for use as in paragraph sucking lice (Linognathus, Solenoptes). (d) of this section. (3) Limitations. Drug is not effective (2) Nos. 046573, 054925, 061623, and against lice eggs. Conditions of con- 076475 for use as in paragraphs (d)(1) stant helminth and ectoparasitic expo- and (d)(2) of this section. sure may require retreatment within 2 (c) Tolerances. See § 556.360 of this to 4 weeks after first treatment. Do not chapter. administer to cattle within 19 days of (d) Conditions of use—(1) Swine—(i) slaughter. Do not administer to dairy Amount. 250 milligrams per gallon of animals of breeding age. Do not use in drinking water to provide 3.8 milli- calves less than 3 months old, or in de- grams per pound of body weight per bilitated animals. Do not treat Brah- day. man bulls. Consult your veterinarian for assistance in the diagnosis, treat- (ii) Indications for use. For the treatment, and control of parasitism. ment of swine dysentery (bloody scours). [53 FR 23757, June 24, 1988, as amended at 54 (iii) Limitations. Discard medicated FR 1353, Jan. 13, 1989; 57 FR 7652, Mar. 4, 1992; drinking water if not used within 2 62 FR 55160, Oct. 23, 1997; 62 FR 61625, Nov. 19, 1997] days. Prepare fresh stock solution daily. Do not use for more than 10 days. § 520.1263 Lincomycin. If clinical signs of disease have not improved within 6 days, discontinue § 520.1263a Lincomycin hydrochloride treatment and reevaluate diagnosis. monohydrate tablets and sirup. The safety of lincomycin has not been (a) Specifications. The sirup contains demonstrated in pregnant swine or lincomycin hydrochloride equivalent swine intended for breeding. For No. to either 25 milligrams or 50 milli- 051259: Do not slaughter swine for 6 grams of lincomycin. days following last treatment. (b) Sponsor. See No. 000009 in (2) Chickens—(i) Amount. 64 milli- § 510.600(c) of this chapter. grams per gallon of drinking water. (c) Conditions of use. (1) The drug is (ii) Indications for use. For the control indicated in infections caused by gram- of necrotic enteritis caused by Clos- positive organisms which are sensitive tridium perfringens susceptible to linco- to its action, particularly streptococci mycin in broiler chickens. and staphylococci. (iii) Limitations. Discard medicated (2) It is administered orally to dogs drinking water if not used within 2 and cats at a dosage level of 10 mgs per days. Prepare fresh stock solution pound of body weight every 12 hours, or daily. Administer for 7 consecutive 7 mgs per pound of body weight every 8 hours. Treatment may be continued for days. Do not allow rabbits, hamsters, periods as long as 12 days if clinical guinea pigs, horses, or ruminants ac- judgment indicates. cess to water containing lincomycin. (3) Federal law restricts this drug to Not for use in layer and breeder chick- use by or on the order of a licensed vet- ens. erinarian. (3) Honey bees—(i) Amount. Mix 100 milligrams lincomycin with 20 grams [40 FR 13838, Mar. 27, 1975, as amended at 44 confectioners’/powdered sugar and dust FR 7130, Feb. 6, 1979; 64 FR 403, Jan. 5, 1999] over the top bars of the brood chamber § 520.1263b [Reserved] once weekly for 3 weeks. (ii) Indications for use. For the control § 520.1263c Lincomycin powder. of American foulbrood (Paenibacillus (a) Specifications. Each gram of solu- larvae). ble powder contains lincomycin hydro- (iii) Limitations. The drug should be chloride equivalent to 0.4 grams of lin- fed early in the spring or late in the comycin. fall and consumed by the bees before (b) Sponsors. See sponsor numbers in the main honey flow begins to avoid § 510.600(c) of this chapter for use as in contamination of production honey. paragraph (d) of this section.

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Complete treatments at least 4 weeks contain liothyronine at 60 or 120 before main honey flow. micrograms per tablet, as the sodium [48 FR 3966, Jan. 28, 1983, as amended at 55 salt. FR 3209, Jan. 31, 1990; 60 FR 14217, Mar. 16, (b) Sponsor. See No. 000069 in 1995; 62 FR 65020, Dec. 10, 1997; 64 FR 13341, § 510.600(c) of this chapter. Mar. 18, 1999; 64 FR 13508, Mar. 19, 1999; 64 FR (c) Conditions of use. (1) It is indicated 66382, Nov. 26, 1999; 65 FR 10705, Feb. 29, 2000; in cases of hypothyroidism in dogs. 67 FR 17284, Apr. 10, 2002; 67 FR 71819, Dec. 3, 2002; 67 FR 78356, Dec. 24, 2002; 68 FR 3817, (2) It is administered orally to dogs Jan. 27, 2003; 70 FR 1818, Jan. 11, 2005; 77 FR at levels up to 12.8 micrograms per 20988, Apr. 9, 2012; 77 FR 29217, May 17, 2012] kilogram of body weight per day. Dos- age should be adjusted according to the § 520.1265 Lincomycin and severity of the condition and the re- spectinomycin powder. sponse of the patient. Dosage at the (a) Specifications. The following salts total replacement level (12.8μg per kilo- of lincomycin and spectinomycin are gram of body weight) should be consid- present in a soluble powder in the ratio ered for initiating therapy and then of 1 to 2 on the basis of equivalency of titrated downward for optimum main- lincomycin base to equivalency of tenance effect. Twice daily administra- spectinomycin base: tion is recommended. (1) Lincomycin hydrochloride (3) Federal law restricts this drug to monohydrate and spectinomycin sul- use by or on the order of a licensed vet- fate tetrahydrate. erinarian. (2) Lincomycin hydrochloride monohydrate and spectinomycin [40 FR 13838, Mar. 27, 1975, as amended at 56 dihydrochloride pentahydrate. FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, (b) Sponsors. See sponsors in 1995] § 510.600(c) of this chapter for use as in paragraph (d) of this section. § 520.1288 Lufenuron tablets. (1) No. 000009 for use of product de- (a) Specifications—(1) Tablets con- scribed in paragraph (a)(1) of this sec- taining 45, 90, 204.9, or 409.8 milligrams tion. (mg) lufenuron for use as in paragraphs (2) Nos. 057561, 061623, and 066104 for (c)(1)(i), (c)(1)(ii)(A), (c)(1)(iii), (c)(2)(i), use of product described in paragraph (c)(2)(ii)(A), and (c)(2)(iii) of this sec- (a)(2) of this section. tion. (c) Tolerances. See §§ 556.360 and (2) Flavored tablets containing 45, 90, 556.600 of this chapter. 204.9, or 409.8 milligrams (mg) (d) Conditions of use in chickens—(1) lufenuron for use as in paragraphs Amount. 2 grams of antibiotic activity (c)(1)(i), (c)(1)(ii)(A) or (c)(1)(ii)(B), and per gallon of drinking water; admin- (c)(1)(iii) of this section. ister as the sole source of water for the (3) Flavored tablets containing 90 or first 5 to 7 days of life. (2) Indications for use. As an aid in the 204.9 mg lufenuron for use as in para- control of airsacculitis caused by ei- graphs (c)(2)(i), (c)(2)(ii)(A) or ther Mycoplasma synoviae or M. (c)(2)(ii)(B), and (c)(2)(iii) of this sec- gallisepticum susceptible to lincomycin- tion. spectinomycin and complicated chron- (4) Flavored tablets containing 135 or ic respiratory disease (air sac infec- 270 mg lufenuron for use as in para- tion) caused by Escherichia coli and M. graphs (c)(2)(i), (c)(2)(ii)(A), and gallisepticum susceptible to lincomycin- (c)(2)(iii) of this section. spectinomycin. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. [69 FR 13220, Mar. 22, 2004, as amended at 70 FR 40881, July 15, 2005; 71 FR 71038, Dec. 8, (c) Conditions of use—(1) Dogs—(i) 2006; 77 FR 56770, Sept. 14, 2012] Amount. Minimum of 10 mg lufenuron per kilogram (4.5 mg per pound (lb)) of § 520.1284 Sodium liothyronine tablets. body weight, once a month. (a) Specifications. Sodium (ii) Indications for use—(A) For the liothyronine tablets consist of tablets prevention and control of flea popu- intended for oral administration which lations.

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(B) The concurrent use of flavored § 520.1310 Marbofloxacin tablets. 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. 000069 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 [64 FR 39919, July 23, 1999, as amended at 66 adult fleas and prevent flea eggs from FR 46369, Sept. 5, 2001] hatching. (iii) Limitations. For use in cats and § 520.1315 Maropitant. kittens 4 weeks of age and older. (a) Specifications. Each tablet con- [68 FR 51905, Aug. 29, 2003] tains 16, 24, 60, or 160 milligrams (mg) maropitant as maropitant citrate. § 520.1289 Lufenuron suspension. (b) Sponsor. See No. 000069 in § 510.600(c) of this chapter. (a) Specifications. Each individual (c) Conditions of use in dogs—(1) Indi- dose pack contains either 135 or 270 cations for use and amount. For the pre- milligrams of lufenuron. vention of acute vomiting, administer (b) Sponsor. See No. 058198 in a minimum of 2.0 mg per kilogram (/ § 510.600(c) of this chapter. kg) body weight once daily for up to 5 (c) Conditions of use in cats—(1) consecutive days. For the prevention of Amount. Minimum of 13.6 milligrams vomiting due to motion sickness, ad- per pound of body weight (30 milli- minister a minimum of 8.0 mg/kg body grams per kilogram). Recommended weight once daily for up to 2 consecu- dose of 135 milligrams for up to 10 tive days. pounds of body weight or 270 milli- (2) Limitations. Federal law restricts grams for 11 to 20 pounds. Cats over 20 this drug to use by or on the order of a pounds are provided the appropriate licensed veterinarian. combination of packs. [72 FR 9243, Mar. 1, 2007] (2) Indications for use. For control of flea populations. § 520.1320 Mebendazole oral. (3) Limitations. For oral use in cats 6 (a) Chemical name. Methyl 5-benzoyl- weeks of age or older, once a month, benzimindazole-2-carbamate. mixed with food. Administer in con- (b) Specifications. As oral powder: junction with a full meal to ensure ade- Each gram contains either 40 or 166.7 quate absorption. Treat all cats in the milligrams of mebendazole. As oral household to ensure maximum bene- paste: Each gram contains 200 milli- fits. Because the drug has no affect on grams of mebendazole. As oral suspen- adult fleas, the concurrent use of insec- sion: Each milliliter contains 33.3 mil- ticides that kill adults may be nec- ligrams of mebendazole. essary depending on the severity of the (c) Sponsor. See No. 000061 in infestation. § 510.600(c) of this chapter. [60 FR 20402, Apr. 26, 1995, as amended at 62 (d) Conditions of use—(1) Horses—(i) FR 8371, Feb. 25, 1997] Amount. 1 gram of mebendazole per 250

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pounds of body weight per dose, as an drug to use by or on the order of a li- oral powder, paste or suspension. censed veterinarian. (ii) Indications for use. It is used in [42 FR 61255, Dec. 2, 1977, as amended at 43 horses for treatment of infections FR 35686, Aug. 11, 1978; 45 FR 3574, Jan. 18, caused by large roundworms (Parascaris 1980; 46 FR 47218, Sept. 25, 1981; 46 FR 53658, equorum); large strongyles (Strongylus Oct. 30, 1981; 62 FR 61625, Nov. 19, 1997] edentatus, S. equinus, S. vulgaris); small strongyles; and mature and immature § 520.1326 Mebendazole and (4th larval stage pinworms (Oxyuris trichlorfon oral dosage forms. equi)). (iii) Limitations—(a) Oral powder. The § 520.1326a Mebendazole and trichlorfon powder. drug is given by sprinkling directly on the grain portion of the ration or dis- (a) Specifications. Each gram of pow- solving in 2 to 4 pints of water and ad- der contains 83.3 milligrams of ministering by stomach tube. The drug mebendazole and 375.0 milligrams of is compatible with carbon disulfide, trichlorofon. which can be used concurrently for (b) Sponsor. See No. 000061 in both control (Gastrophilus spp. ). Rou- § 510.600(c) of this chapter. tine cautions regarding the use of car- (c) Conditions of use. Horses—(1) bon disulfide must be observed. Do not Amount. 8.8 milligrams of mebendazole administer to horses intended for use and 40 milligrams of trichlorofon per as food. Federal law restricts this drug kilogram of body weight. to use by or on the order of a licensed (2) Indications for use. It is used in veterinarian. horses for the treatment of infections (b) Oral paste. The drug is given by of bots (Gastrophilus intestinalis and G. dosing gun (syringe), inserting the tip nasalis), large roundworms (Parascaris of the gun at the interdental space in equorum), large strongyles (Strongylus the horse’s mouth and depositing the edentatus, S. equinus, S. vulgaris), small paste on the animal’s tongue. The hand strongyles, and pinworms (Oxyuris is placed under the animal’s jaw, and equi.) the head is raised to assure that the (3) Limitations. Administer orally as paste is deposited on the roof of the an individual dose by stomach tube or mouth. Not for use in horses intended throughly mixed in the ground grain for food. Consult your veterinarian for portion of the ration to be consumed in assistance in the diagnosis, treatment, one feeding. Discard treated feed not and control of parasitism. consumed. Do not administer more (c) Oral suspension. The drug is ad- than once every 30 days. Do not treat ministered by stomach tube. Not for sick or debilitated animals, foals under horses intended for food use. Federal 4 months of age, or mares in the last law restricts this drug to use by or on month of pregnancy. Trichlorofon is a the order of a licensed veterinarian. cholinesterase inhibitor. Do not admin- (2) Dogs—(i) Amount. One hundred ister simultaneously or within a few milligrams of mebendazole per 10 days before or after treatment with, or pounds of body weight, once daily for 3 exposure to, cholinesterase-inhibiting days, as an oral powder. drugs, pesticides or chemicals. Do not (ii) Indications for use. The drug is administer intravenous anesthetics, es- used for treatment of infections of pecially muscle relaxants, concur- roundworms (Toxocara canis), rently. Not for horses intended for food hookworms (Ancylostoma caninum, use. Federal law restricts this drug to Uncinaria stenocephala), whipworms use by or on the order of a licensed vet- (Trichuris vulpis), and tapeworms erinarian. (Taenia pisiformis). [45 FR 10759, Feb. 19, 1980, as amended at 46 (iii) Limitations. Administer as an FR 52330, Oct. 27, 1981. Redesignated at 51 FR oral powder by mixing with a small 13212, Apr. 18, 1986, as amended at 62 FR quantity of food, preferably before the 61625, Nov. 19, 1997] regular meal. Federal law restricts this

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§ 520.1326b Mebendazole and tenance dosage level should be individ- trichlorfon paste. ualized for each animal. (a) Specifications. Each gram of paste (4) This drug should not be adminis- contains 100 milligrams of mebendazole tered to horses with active gastro- and 454 milligrams of trichlorfon. intestinal, hepatic, or renal disease. (b) Sponsor. See No. 000061 in (5) Not for use in horses intended for § 510.600(c) of this chapter. food. (c) Conditions of use—(1) Amount. 8.8 (6) Federal law restricts this drug to milligrams of mebendazole and 40 mil- use by or on the order of a licensed vet- ligrams of trichlorfon per kilogram of erinarian. body weight. [41 FR 5632, Feb. 9, 1976, as amended at 53 FR (2) Indications for use. It is used in 23390, June 22, 1988] horses for treatment of infections of bots (Gastrophilus intestinalis and G. na- § 520.1331 Meclofenamic acid tablets. salis), large roundworms (Parascaris (a) Specifications. Each tablet con- equorum), large strongyles (Strongylus tains either 10 or 20 milligrams of edentatus, S. equinus, S. vulgaris), small meclofenamic acid. strongyles, and pinworms (Oxyuris (b) Sponsor. See No. 000856 in equi). § 510.600(c) of this chapter. (3) Limitations. Do not administer (c) Conditions of use in dogs—(1) more than once every 30 days. Do not Amount. 1.1 milligrams per kilogram treat sick or debilitated animals, foals (0.5 milligram per pound) daily for 5 to under 4 months of age, or mares in the 7 days. last month of pregnancy. Trichlorfon is (2) Indications for use. For the relief of a cholinesterase inhibitor. Do not ad- signs and symptoms of chronic inflam- minister simultaneously or within a matory disease involving the musculo- few days before or after treatment skeletal system. with, or exposure to, cholinesterase-in- (3) Limitations. For oral use only. hibiting drugs, pesticides, or chemi- Should not be administered to animals cals. Do not administer intravenous with congestive heart failure or active anesthetics, especially muscle relax- gastrointestinal, hepatic, or renal dis- ants, concurrently. Not for use in ease. Federal law restricts this drug to horses intended for food. Consult your use by or on the order of a licensed vet- veterinarian for assistance in the diag- erinarian. nosis, treatment, and control of parasitism. [50 FR 43385, Oct. 25, 1985, as amended at 53 FR 23390, June 22, 1988] [51 FR 13212, Apr. 18, 1986, as amended at 62 FR 61625, Nov. 19, 1997] § 520.1341 Megestrol acetate tablets. (a) Specifications. Each tablet con- § 520.1330 Meclofenamic acid granules. tains 5 or 20 milligrams of megestrol (a) Chemical name. N-(2,6-Dichlorom- acetate. tolyl) anthranilic acid. (b) Sponsor. No. 000061 in § 510.600(c) of (b) Specifications. The drug is in this chapter. granular form containing 5 percent (c) Conditions of use. (1) The drug is meclofenamic acid. used in female dogs for the postpone- (c) Sponsor. See No. 000856 in ment of estrus and the alleviation of § 510.600(c) of this chapter. false pregnancy. (d) Conditions of use. (1) The drug is (2) It is administered orally, intact, used in horses for the treatment of or crushed and mixed with food as fol- acute or chronic inflammatory diseases lows: involving the musculoskeletal system. (i) For the postponement of estrus by (2) It is administered orally at a dos- proestrus treatment, 1 milligram per age of 1 milligram per pound of body pound of body weight per day for 8 weight (1 gram per 1,000 pounds) once days. daily for 5 to 7 days by addition to the (ii) For the postponement of estrus daily grain ration. by anestrus treatment, 0.25 milligram (3) Treatment beyond the initial 5- to per pound of body weight per day for 32 7-day period may be indicated. A main- days.

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(iii) For alleviation of false preg- (3) Limitations. Federal law restricts nancy, 1 milligram per pound of body this drug to use by or on the order of a weight per day for 8 days. licensed veterinarian. (3) Full dosage regimen must be com- [68 FR 42968, July 21, 2003, as amended at 69 pleted to produce the desired effect. FR 69523, Nov. 30, 2004. Redesignated and (4) Examination of vaginal smears is amended at 78 FR 57058, Sept. 17, 2013] recommended to confirm detection of proestrus. § 520.1372 Methimazole. (5) Do not administer for more than (a) Specifications. Each tablet con- two consecutive treatments. tains 2.5 or 5 milligrams (mg) (6) Once therapy is started, the ani- methimazole. mal should be confined for 3 to 8 days (b) Sponsor. See No. 043264 in § 510.600 or until cessation of bleeding, since of this chapter. dogs in proestrus accept a male. (c) Conditions of use in cats—(1) (7) Do not use prior to or during first Amount. The starting dose is 2.5 mg estrus cycle. every 12 hours. Following 3 weeks of (8) Do not use in pregnant animals. treatment, the dose should be titrated to effect based on individual serum (9) Do not use in the presence of a total T4 levels and clinical response. disease of the reproductive system or (2) Indications for use. For the treat- with mammary tumors. ment of hyperthyroidism. (10) Should estrus occur within 30 (3) Limitations. Federal law restricts days after cessation of treatment, mat- this drug to use by or on the order of a ing should be prevented. licensed veterinarian. (11) Federal law restricts this drug to use by or on the order of a licensed vet- [74 FR 27707, June 11, 2009] erinarian. § 520.1380 Methocarbamol tablets. [40 FR 13838, Mar. 27, 1975, as amended at 52 (a) Chemical name. 3-(O- FR 7832, Mar. 13, 1987] Methoxyphenoxy)-1,2-propanediol 1- carbamate. § 520.1367 Meloxicam. (b) Specifications. Each tablet con- (a) Specifications—(1) Each milliliter tains 500 milligrams of methocarbamol. of suspension contains 0.5 milligrams (c) Sponsor. See No. 000856 in (mg) meloxicam. § 510.600(c) of this chapter. (2) Each milliliter of suspension con- (d) Conditions of use. (1) The drug is tains 1.5 mg meloxicam. administered to dogs and cats as an ad- (b) Sponsors. See sponsors in junct to therapy for acute inflam- § 510.600(c) of this chapter for uses as in matory and traumatic conditions of paragraph (c) of this section: the skeletal muscles in order to reduce (1) No. 000010 for use of the products muscular spasms. described in paragraph (a) of this sec- (2) Dosage is based upon severity of tion; and symptoms and response noted. The usual initial dose in 60 milligrams per (2) No. 013744 for use of the product pound of body weight in two or three described in paragraph (a)(2) of this equally divided doses followed by 30 to section. 60 milligrams per pound of body weight (c) Conditions of use in dogs—(1) each following day, usually not to ex- Amount. Administer orally as a single ceed 14 to 21 days. dose at 0.09 mg per pound (mg/lb) body (3) For use only by or on the order of weight (0.2 mg per kilogram (mg/kg)) a licensed veterinarian. on the first day of treatment. For all treatment after day 1, administer 0.045 [40 FR 13838, Mar. 27, 1975, as amended at 67 FR 67521, Nov. 6, 2002] mg/lb (0.1 mg/kg) body weight once daily. § 520.1408 Methylprednisolone tablets. (2) Indications for use. For the control (a) Specifications. Each table contains of pain and inflammation associated 1, 2, or 4 milligrams of with osteoarthritis. methylprednisolone.

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(b) Sponsor. See No. 000009 in methylprednisolone and 300 milligrams § 510.600(c) of this chapter for use of 1- of aspirin. and 4-milligram tablets; see No. 054628 (b) Sponsor. See No. 000009 in for use of 1- and 2-milligram tablets. § 510.600(c) of this chapter. (c) [Reserved] (c) NAS/NRC status. The conditions of (d) Special consideration. (1) Clinical use have been NAS/NRC reviewed and and experimental data have dem- found effective. New animal drug appli- onstrated that corticosteroids adminis- cations for approval of drugs for these tered orally or parenterally to animals conditions of use need not include ef- may induce the first stage of parturi- fectiveness data specified by § 514.111 of tion when administered during the last this chapter, but may require bio- trimester of pregnancy and may pre- equivalency and safety information. cipitate premature parturition fol- (d) Special considerations. (1) Clinical lowed by dystocia, fetal death, retained and experimental data have dem- placenta, and metritis. onstrated that corticosteroids adminis- (2) Systemic therapy with tered orally or parenterally to animals methylprednisolone is contraindicated may induce the first stage of parturi- in animals with arrested tuberculosis, tion when administered during the last peptic ulcer, acute psychoses, or trimester of pregnancy and may pre- cushingoid syndrome. The presence of cipitate premature parturition fol- active tuberculosis, diabetes, lowed by dystocia, fetal death, retained osteoporosis, chronic psychotic reac- placenta, and metritis. tions, predisposition to (2) Systemic therapy with thrombophlebitis, hypertension, con- methylprednisolone is contraindicated gestive heart failure, or renal insuffi- in animals with tuberculosis, chronic ciency necessitates carefully con- nephritis, peptic ulcer, or Cushingoid trolled use of corticosteroids. Some of syndrome. The presence of diabetes these conditions occur only rarely in mellitus, osteoporosis, predisposition dogs and cats but should be kept in to thrombophlebitis, hypertension, mind. congestive heart failure, or renal insuf- (3) Anti-inflammatory action of ficiency necessitates carefully con- corticosteroids may mask signs of in- trolled use of corticosteroids. fection. (3) Anti-inflammatory action of (e) Conditions of use—(1) Amount. Dogs corticosteroids may mask signs of in- and cats: 5 to 15 pounds, 2 milligrams; fection. 15 to 40 pounds, 2 to 4 milligrams; 40 to (e) Conditions of use—(1) Amount. Dogs 80 pounds, 4 to 8 milligrams. 1 under 15 pounds, ⁄4 to 1 tablet daily; 15 (2) Indications for use. For use in dogs to 60 pounds, 1 to 2 tablets daily; 60 and cats as an anti-inflammatory pounds and over, 2 tablets daily. agent. (2) Indications for use. As an anti-in- (3) Limitations. Administer total daily flammatory and analgesic agent in dose orally in equally divided doses 6 to dogs. 10 hours apart until response is noted (3) Limitations. Administer total daily or 7 days have elapsed. When response dose in divided doses 6 to 10 hours is attained, dosage should be gradually apart, with a light feeding. When re- reduced until maintenance level is sponse is attained, dosage should be achieved. Hazardous for human use. gradually reduced until maintenance Federal law restricts this drug to use level is achieved. Do not administer to by or on the order of a licensed veteri- cats. Do not overdose. Federal law re- narian. stricts this drug to use by or on the [47 FR 52697, Nov. 23, 1982, as amended at 49 order of a licensed veterinarian. FR 20810, May 17, 1984; 50 FR 32844, Aug. 15, 1985; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, [48 FR 21566, May 13, 1983] June 30, 1997; 78 FR 21059, Apr. 9, 2013] § 520.1422 Metoserpate hydrochloride. § 520.1409 Methylprednisolone, aspirin (a) Chemical name. Methyl-o-methyl- tablets. 18-epireserpate hydrochloride. (a) Specifications. Each tablet con- (b) Sponsor. See No. 053501 in tains 0.5 milligram of § 510.600(c) of this chapter.

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(c) Related tolerances. See § 556.410 of (3) Limitations. Administer daily, this chapter. orally or in a small amount of food, at (d) Conditions of use. It is used in least 30 days before expected initiation drinking water for replacement chick- of heat, and continue daily as long as ens as follows: desired, but not for more than 24 (1) Amount. 568.5 milligrams per gal- months. Mibolerone should not be used lon (0.015 percent). in bitches before the first estrous pe- (i) Indications for use. As a tranquil- riod. It is not intended for animals izer for flock treatment of chickens being used primarily for breeding pur- prior to handling. poses. Use orally in adult female dogs (ii) Limitations. To be used one time only. Federal law restricts this drug to as a treatment for replacement chick- use by or on the order of a licensed vet- ens up to 16 weeks of age; usual drink- erinarian. ing water should be withheld prior to [43 FR 15625, Apr. 14, 1978] treatment to provide adequate consumption of medicated drinking water; § 520.1441 Milbemycin oxime. not for use in laying chickens; chick- (a) Specifications—(1) Dogs. Each tab- ens slaughtered within 72 hours fol- let contains 2.3, 5.75, 11.5, or 23.0 milli- lowing treatment must not be used for grams of milbemycin oxime. food. (2) Cats. Each tablet contains 5.75, (2) Amount. 2 to 4 milligrams per 2.2 11.5, or 23.0 milligrams of milbemycin pounds of body weight. oxime. (i) Indications for use. As an aid in (b) Sponsor. See 058198 in § 510.600(c) of control of hysteria. this chapter. (ii) Limitations. To be used as a treat- (c) [Reserved] ment for replacement chickens up to 16 (d) Conditions of use—(1) Dogs and weeks of age; usual drinking water puppies—(i) Amount. For hookworm, should be withheld prior to treatment roundworm, and whipworm, use 0.23 to provide adequate consumption of milligram per pound of body weight (0.5 medicated drinking water; the drug milligram per kilogram). For heart- should be administered at a dosage worm, use 0.05 milligram per pound of level of 4 milligrams per 2.2 pounds of body weight (0.1 milligram per kilo- body weight followed by 2 treatments gram). at 4-day intervals of 2 milligrams per (ii) Indications for use. For prevention 2.2 pounds of body weight; not for use of heartworm disease caused by in laying chickens; chickens slaugh- Dirofilaria immitis, control of hookworm tered within 72 hours following treat- infections caused by Ancylostoma ment must not be used for food. caninum, and removal and control of adult roundworm infections caused by [40 FR 13838, Mar. 27, 1975, as amended at 76 Toxocara canis and Toxascaris leonina FR 17337, Mar. 29, 2011] and whipworm infections caused by Trichuris vulpis in dogs and in puppies 4 § 520.1430 Mibolerone. weeks of age or greater and 2 pounds of (a) Specifications. Each milliliter con- body weight or greater. tains 100 micrograms of mibolerone. (iii) Limitations. Do not use in puppies (b) Sponsor. See No. 000009 in less than 4 weeks of age and less than § 510.600(c) of this chapter. 2 pounds of body weight. Administer (c) Conditions of use—(1) Amount. 30 once a month. First dose given within micrograms for animals weighing 1 to 1 month after first exposure to mosqui- 25 pounds; 60 micrograms for animals toes and continue regular use until at weighing 26 to 50 pounds; 120 least 1 month after end of mosquito micrograms for animals weighing 51 to season. Federal law restricts this drug 100 pounds; 180 micrograms for animals to use by or on the order of a licensed weighing over 100 pounds, German veterinarian. Shepherds, or German Shepherd mix. (2) Cats and kittens—(i) Amount. 0.91 (2) Indications for use. For the preven- milligram per pound of body weight (2.0 tion of estrus (heat) in adult female milligrams per kilogram). dogs not intended primarily for breed- (ii) Indications for use. For prevention ing purposes. of heartworm disease caused by

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Dirofilaria immitis and the removal of indicated to kill adult fleas and pre- adult Toxocara cati (roundworm) and vent flea eggs from hatching. Ancylostoma tubaeforme (hookworm) in- (iii) Limitations. Federal law restricts fections in cats 6 weeks of age or great- this drug to use by or on the order of a er and 1.5 pounds body weight or great- licensed veterinarian. er. (2) [Reserved] (iii) Limitations. Do not use in kittens [62 FR 28629, May 27, 1997, as amended at 63 less than 6 weeks of age or 1.5 pounds FR 41190, Aug. 3, 1998; 68 FR 51905, Aug. 29, body weight. Administer once a month. 2003. Redesignated at 77 FR 47512, Aug. 9, Federal law restricts this drug to use 2012] by or on the order of a licensed veterinarian. § 520.1445 Milbemycin oxime and 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, 1993; 60 FR 50097, Sept. 28, 1995; 61 FR 43654, let contains: Aug. 26, 1996; 63 FR 29352, May 29, 1998; 63 FR (1) 2.3 milligrams (mg) milbemycin 41189, Aug. 3, 1998. Redesignated at 77 FR oxime and 22.8 mg praziquantel; 47512, Aug. 9, 2012] (2) 5.75 mg milbemycin oxime and 57 mg praziquantel; § 520.1443 Milbemycin oxime and (3) 11.5 mg milbemycin oxime and 114 lufenuron. mg praziquantel; or (a) Specifications—(1) Tablets con- (4) 23 mg milbemycin oxime and 228 taining: 2.3 milligrams (mg) mg praziquantel. milbemycin oxime and 46 mg (b) Sponsor. See No. 058198 in lufenuron, 5.75 mg milbemycin oxime § 510.600(c) of this chapter. and 115 mg lufenuron, 11.5 mg (c) Conditions of use—(1) Dogs—(i) milbemycin oxime and 230 mg Amount. Administer orally, once a lufenuron, or 23 mg milbemycin oxime month, a minimum dosage of 0.23 mg and 460 mg lufenuron. per pound (mg/lb) of body weight (0.5 (2) Flavored tablets containing: 2.3 mg per kilogram (mg/kg)) milbemycin mg milbemycin oxime and 46 mg oxime and 2.28 mg/lb of body weight (5 lufenuron, 5.75 mg milbemycin oxime mg/kg) praziquantel. and 115 mg lufenuron, 11.5 mg (ii) Indications for use. For the pre- milbemycin oxime and 230 mg vention of heartworm disease caused lufenuron, or 23 mg milbemycin oxime by Dirofilaria immitis and for the treat- and 460 mg lufenuron. ment and control of adult roundworm (b) Sponsor. See No. 058198 in (Toxocara canis, Toxascaris leonina), § 510.600(c) of this chapter. adult hookworm (Ancylostoma (c) [Reserved] caninum), adult whipworm (Trichuris (d) Conditions of use—(1) Dogs—(i) vulpis), and adult tapeworm (Taenia Amount. 0.5 mg milbemycin oxime and pisiformis, Echinococcus multilocularis, 10 mg lufenuron per kilogram of body and E. granulosus) infections in dogs weight, once a month. and puppies 2 pounds of body weight or (ii) Indications for use—(A) For use in greater and 6 weeks of 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] for removal and control of adult Toxocara canis, Toxascaris leonina § 520.1447 Milbemycin oxime, (roundworm), and Trichuris vulpis lufenuron, and praziquantel tablets. (whipworm) infections. (a) Specifications. Each tablet con- (B) The concurrent use of flavored tains: milbemycin oxime and lufenuron tab- (1) 2.3 milligrams (mg) milbemycin lets described in paragraph (a)(2) of oxime, 46 mg lufenuron, and 22.8 mg this section as in paragraph (d)(1)(ii)(A) praziquantel; of this section with nitenpyram tablets (2) 5.75 mg milbemycin oxime, 115 mg as in § 520.1510(d)(1) of this chapter is lufenuron, and 57 mg praziquantel;

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(3) 11.5 mg milbemycin oxime, 230 mg spp.), and worms of the large intestine lufenuron, and 114 mg praziquantel; or (Oesophagostomum radiatum). (4) 23 mg milbemycin oxime, 460 mg (3) Limitations. Conditions of constant lufenuron, and 228 mg praziquantel. worm exposure may require retreat- (b) Sponsor. See No. 058198 in ment in 2 to 4 weeks. Consult your vet- § 510.600(c) of this chapter. erinarian before administering to se- (c) [Reserved] verely debilitated animals and for as- (d) Conditions of use—(1) Dogs—(i) sistance in the diagnosis, treatment, Amount. 0.5 mg milbemycin oxime, 10 and control of parasitism. Do not treat mg lufenuron, and 5 mg of praziquantel within 14 days of slaughter. per kilogram of body weight, once a month. [46 FR 50949, Oct. 16, 1981. Redesignated at 49 (ii) Indications for use. For the pre- FR 47831, Dec. 7, 1984, and amended at 51 FR vention of heartworm disease caused 9005, Mar. 17, 1986] by Dirofilaria immitis; for the prevention and control of flea populations § 520.1450b Morantel tartrate car- (Ctenocephalides felis); and for the treat- tridge. ment and control of adult roundworm (a) Specifications. The drug product (Toxocara canis, Toxascaris leonina), consists of a stainless-steel cylinder adult hookworm (Ancylostoma having both ends closed with poly- caninum), adult whipworm (Trichuris ethylene diffusing discs and containing vulpis), and adult tapeworm (Taenia a morantel tartrate paste. The paste pisiformis, Echinococcus multilocularis, contains 22.7 grams of morantel tar- and E. granulosus) infections in dogs trate equivalent to 13.5 grams of and puppies 2 pounds of body weight or morantel base. greater and 6 weeks of age and older. (iii) Limitations. Federal law restricts (b) Sponsor. See No. 000069 in this drug to use by or on the order of a § 510.600(c) of this chapter. licensed veterinarian. (c) Related tolerances. See § 556.425 of (2) [Reserved] this chapter. (d) Conditions of use—(1) Amount. [77 FR 4225, Jan. 27, 2012] Grazing cattle: Administer 1 cartridge § 520.1450 Morantel tartrate oral dos- to each animal at the start of the graz- age 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. 000069 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 bolus; 326 to 600 pounds, 1 bolus; 601 to mately 90 days following administration. Therefore, treated cattle should 900 pounds, 11⁄2 boluses; and 901 to 1,200 pounds, 2 boluses. not be moved to pastures grazed in the (2) Indications for use. For removal same grazing season/calendar year by and control of mature gastrointestinal untreated cattle. Do not administer to nematode infections of cattle including cattle within 106 days of slaughter. stomach worms (Haemonchus spp., Ostertagia spp., Trichostrongylus spp.), worms of the small intestine (Cooperia spp., Trichostrongylus spp., Nematodirus

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Consult your veterinarian before ad- (b) Sponsor. See No. 000856 in ministering to severely debilitated ani- § 510.600(c) of this chapter. mals and for assistance in the diag- (c) [Reserved] nosis, treatment, and control of para- (d) Conditions of use—(1) Amount. 3 sitism. micrograms per kilogram (1.36 [49 FR 47831, Dec. 7, 1984, as amended at 51 micrograms per pound) of body weight. FR 23415, June 27, 1986; 51 FR 41081, Nov. 13, (2) Indications for use. To prevent in- 1986] fection by the canine heartworm Dirofilaria immitis and the subsequent § 520.1450c Morantel tartrate sus- development of canine heartworm dis- tained-release trilaminate cylinder/ ease. sheet. (3) Limitations. Use once-a-month in (a) Specifications. The drug product dogs at 8 weeks of age or older. Federal consists of a trilaminated, perforated, law restricts this drug to use by or on plastic sheet formed into a cylinder the order of a licensed veterinarian. having plastic plugs in its ends. The [62 FR 37713, July 15, 1997] core lamina contains 19.8 grams of morantel tartrate equivalent to 11.8 § 520.1452 Moxidectin gel. grams of morantel base. (b) Sponsor. See 000069 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. 000856 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 L4 larval stages); pinworms: Oxyuris [56 FR 13396, Apr. 2, 1991] 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

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instars). One dose also suppresses (3) Limitations. For oral use in horses strongyle egg production for 84 days. and ponies 6 months of age and older. (3) Limitations. For oral use in horses Not for use in horses and ponies in- and ponies 6 months of age and older. tended for food. Not for use in horses and ponies in- [68 FR 51446, Aug. 27, 2003, as amended at 69 tended for food. FR 21956, Apr. 23, 2004; 70 FR 75017, Dec. 19, [62 FR 42902, Aug. 11, 1997, as amended at 64 2005] FR 66105, Nov. 24, 1999; 68 FR 51445, Aug. 27, 2003; 69 FR 24959, May 5, 2004; 70 FR 75017, § 520.1454 Moxidectin solution. Dec. 19, 2005] (a) Specifications. Each milliliter (mL) of solution contains 1 milligram § 520.1453 Moxidectin and (mg) moxidectin. praziquantel gel. (b) Sponsor. See No. 000010 in (a) Specifications. Each milliliter of § 510.600(c) of this chapter. gel contains 20 milligrams (mg) (2.0 (c) Related tolerances. See § 556.426 of percent) moxidectin and 125 mg (12.5 this chapter. percent) praziquantel. (d) Special considerations. See § 500.25 (b) Sponsor. See No. 000856 in of this chapter. § 510.600(c) of this chapter. (e) Conditions of use in sheep—(1) (c) Special considerations. See § 500.25 Amount. Administer 1 mL per 11 pounds of this chapter. body weight (1 mL per 5 kilograms) by (d) Conditions of use in horses and mouth. ponies—(1) Amount. Administer by (2) Indications for use. For the treat- mouth as a single dose: 0.4 mg ment and control of the adult and L4 moxidectin per kilogram and 2.5 mg larval stages of Haemonchus contortus, praziquantel per kilogram (2.2 pounds) Teladorsagia circumcincta, T. trifurcata, body weight. Trichostrongylus axei, T. colubriformis, T. (2) Indications for use. For the treat- vitrinus, Cooperia curticei, C. oncophora, ment and control of large strongyles: Oesophagostomum columbianum, O. Strongylus vulgaris (adults and L4/L5 ar- venulosum, Nematodirus battus, N. terial stages), S. edentatus (adult and filicollis, and N. spathiger. tissue stages), Triodontophorus (3) Limitations. Sheep must not be brevicauda (adults), and T. serratus slaughtered for human consumption (adults); small strongyles (adults): within 7 days of treatment. Because a (Cyathostomum spp., including C. withholding time in milk has not been catinatum and C. pateratum; Cylicocyclus established for this product, do not use spp., including C. insigne, C. in female sheep providing milk for leptostomum, C. nassatus, and C. human consumption. radiatus; Cylicostephanus spp., including [70 FR 76163, Dec. 23, 2005, as amended at 76 C. calicatus, C. goldi, C. longibursatus, FR 48714, Aug. 9, 2011] and C. minutus; Coronocyclus spp., including C. coronatus, C. labiatus, and C. § 520.1468 Naproxen granules. labratus; Gyalocephalus capitatus; and (a) Specifications. Naproxen granules Petrovinema poculatus; small contain 50 percent naproxen. strongyles: undifferentiated lumenal (b) Sponsor. No. 000856 in § 510.600(c) of larvae; encysted cyathostomes (late L3 this chapter. and L4 mucosal cyathostome larvae); (c) Conditions of use—(1) Horses. The ascarids: Parascaris equorum (adults and drug is used for the relief of inflamma- L4 larval stages); pinworms: Oxyuris tion and associated pain and lameness equi (adults and L4 larval stages); exhibited with arthritis, as well as my- hairworms: Trichostrongylus axei ositis and other soft tissue diseases of (adults); large-mouth stomach worms: the musculoskeletal system of the Habronema muscae (adults); horse stom- horse. ach bots: Gasterophilus intestinalis (2nd (2)(i) For oral maintenance therapy and 3rd instars) and G. nasalis (3rd following initial intravenous dosage, instars); and tapeworms: Anoplocephala administer 10 milligrams naproxen per perfoliata (adults). One dose also sup- kilogram of animal body weight twice presses strongyle egg production for 84 daily as top dressing in the animal’s days. feed for up to 14 consecutive days. The

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initial intravenous dosage is 5 milli- terial enteritis) caused by Escherichia grams per kilogram of body weight. coli susceptible to neomycin sulfate. (ii) For oral dosage only, administer (iii) Limitations. Add powder to drink- 10 milligrams naproxen per kilogram of ing water or milk; not for use in liquid animal body weight twice daily as a supplements. Administer solution undi- top dressing in the animal’s feed for up luted or in drinking water. Prepare a to 14 consecutive days. fresh solution in drinking water daily. (3) Not for use in horses intended for If symptoms persist after using this food. preparation for 2 or 3 days, consult a (4) Federal law restricts this drug to veterinarian. Treatment should con- use by or on the order of a licensed vet- tinue 24 to 48 hours beyond remission erinarian. of disease symptoms, but not to exceed a total of 14 consecutive days. Dis- [41 FR 14188, Apr. 2, 1976, as amended at 51 continue treatment prior to slaughter FR 24525, July 7, 1986; 61 FR 5506, Feb. 13, as follows: Cattle, 1 day; sheep, 2 days; 1996] swine and goats, 3 days. § 520.1484 Neomycin. (2) Turkeys—(i) Amount. 10 mg/lb of body weight per day (22 mg/kg) for 5 (a) Specifications—(1) Each ounce of days. powder contains 20.3 grams (g) neomy- (ii) Indications for use. For the control cin sulfate (equivalent to 14.2 g neomy- of mortality associated with E. coli sus- cin base). ceptible to neomycin sulfate in grow- (2) Each milliliter of solution con- ing turkeys. tains 200 milligrams (mg) neomycin (iii) Limitations. Add to drinking sulfate (equivalent to 140 mg neomycin water; not for use in liquid supple- base). ments. Prepare a fresh solution daily. (b) Sponsors. See sponsors in If symptoms persist after using this § 510.600(c) of this chapter for use as in preparation for 2 or 3 days, consult a paragraph (e) of this section. veterinarian. Treatment should con- (1) Nos. 000069 and 054925 for use of tinue 24 to 48 hours beyond remission product described in paragraph (a)(1) as of disease symptoms, but not to exceed in paragraph (e)(1) of this section. a total of 5 consecutive days. (2) Nos. 000009, 046573, 058005, and [71 FR 56866, Sept. 28, 2006, as amended at 71 061623 for use of product described in FR 68738, Nov. 28, 2006; 78 FR 17596, Mar. 22, paragraph (a)(1) as in paragraphs (e)(1) 2013] and (e)(2) of this section. (3) Nos. 000009, 000859, 054925, and § 520.1510 Nitenpyram tablets. 058005 for use of product described in (a) Specifications. Each tablet con- paragraph (a)(2) as in paragraph (e)(1) tains 11.4 or 57 milligrams (mg) of this section. nitenpyram. (c) Related tolerances. See § 556.430 of (b) Sponsor. See No. 058198 in this chapter. § 510.600(c) of this chapter. (d) Special labeling considerations. La- (c) Special considerations. The concur- beling shall bear the following warning rent use of nitenpyram tablets and fla- statements: ‘‘A withdrawal period has vored milbemycin/lufenuron tablets as not been established for use in in paragraph (d)(1)(ii)(B) of this section preruminating calves. Do not use in shall be by or on the order of a licensed calves to be processed for veal. Use of veterinarian. more than one product containing neo- (d) Conditions of use—(1) Dogs—(i) mycin or failure to follow withdrawal Amount—(A) One 11.4-mg tablet for times may result in illegal drug resi- dogs weighing less than 25 pounds (lb) dues.’’ or one 57-mg tablet for dogs weighing (e) Conditions of use—(1) Cattle, swine, more than 25 lb, as needed, for use as in sheep, and goats—(i) Amount. 10 mg per paragraph (d)(1)(ii)(A) of this section. pound (/lb) of body weight per day (22 (B) One 11.4-mg tablet for dogs weigh- mg per kilogram (/kg)) in divided doses ing less than 25 lb or one 57 mg tablet for a maximum of 14 days. for dogs weighing more than 25 lbs, (ii) Indications for use. For the treat- once or twice weekly, for use as in ment and control of colibacillosis (bac- paragraph (d)(1)(ii)(B) of this section.

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(ii) Indications for use—(A) For the (c) Special considerations. When la- treatment of flea infestations on dogs beled for use as in paragraph (d)(2)(i) of and puppies 4 weeks of age and older this section, product labeling shall and 2 lbs of body weight or greater. bear: ‘‘Federal law restricts this drug (B) The concurrent use of nitenpyram to use by or on the order of a licensed tablets as in paragraph (d)(1)(i)(B) of veterinarian.’’ this section with either flavored (d) Conditions of use in horses—(1) lufenuron tablets as in § 520.1288(c)(1) of Amount—(i) For treatment of gastric this chapter or flavored milbemycin ulcers, 1.8 milligrams per pound (mg/lb) and lufenuron tablets as in of body weight (4 milligrams per kilo- § 520.1446(d)(1) of this chapter is indi- gram (mg/kg)) once daily for 4 weeks. cated to kill adult fleas and prevent For prevention of recurrence of gastric flea eggs from hatching. ulcers, 0.9 mg/lb of body weight (2 mg/ (2) Cats—(i) Amount—(A) One 11.4-mg kg) once daily for at least an addi- tablet, as needed, for use as in para- tional 4 weeks. graph (d)(2)(ii)(A) of this section. (ii) For prevention of gastric ulcers (B) One 11.4-mg tablet, once or twice using the premarked syringe, one dose weekly, for use as in paragraph per day for 8 or 28 days. Each dose de- (d)(2)(ii)(B) of this section. livers at least 1 mg/kg of body weight. (ii) Indications for use—(A) For the Horses over 1,200 lb body weight should treatment of flea infestations on cats receive two doses per day. and kittens 4 weeks of age and older (2) Indications for use. (i) For treat- and 2 lbs of body weight or greater. ment and prevention of recurrence of (B) The concurrent use of nitenpyram gastric ulcers in horses and foals 4 tablets as in paragraph (d)(2)(i)(B) of weeks of age and older. this section with flavored lufenuron (ii) For prevention of gastric ulcers tablets as in § 520.1288(c)(2) of this chap- in horses. ter is indicated to kill adult fleas and (3) Limitations. Do not use in horses prevent flea eggs from hatching. intended for human consumption. [68 FR 51906, Aug. 29, 2003] [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 con- (a) Specifications. Each tablet contains 3.6, 5.4, or 16 milligrams (mg) of tains 5.7, 22.7, or 68 milligrams (mg) oclacitinib as oclacitinib maleate. orbifloxacin. (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—(1) Amount. Ad- (c) Conditions of use in dogs and cats— minister orally 0.18 to 0.27 mg/per (1) Amount. 2.5 to 7.5 mg per kilogram pound of body weight (0.4 to 0.6 mg/kg body weight once daily. body weight) twice daily for up to 14 (2) Indications for use. For manage- days; then administered once daily for ment of diseases associated with bac- maintenance therapy. teria susceptible to orbifloxacin. (2) Indications for use. For control of (3) Limitations. Federal law restricts pruritus associated with allergic der- this drug to use by or on the order of a matitis and control of atopic derma- licensed veterinarian. Federal law pro- titis in dogs at least 12 months of age. hibits the extralabel use of this drug in (3) Limitations. Federal law restricts food producing animals. this drug to use by or on the order of a 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.

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(c) Special considerations. Federal law ringe. Discard unused portions of sus- restricts this drug to use by or on the pension after 24 hours. Mix drug ac- order of a licensed veterinarian. Fed- cording to directions prior to use. Ad- eral law prohibits the extralabel use of minister drug with caution to sick or this drug in food-producing animals. debilitated horses. Not for use in (d) Conditions of use—(1) Dogs—(i) horses intended for food. Federal law Amount. 1.1 to 3.4 mg/lb (2.5 to 7.5 mg/ restricts this drug to use by or on the kg) of body weight once daily. order of a licensed veterinarian. (ii) Indications for use. For the treat- (ii) Pellets. The drug is given by sprin- ment of urinary tract infections (cys- kling on the grain portion of the ra- titis) in dogs caused by susceptible tion. Withholding feed or water prior strains of Staphylococcus to administration is not necessary. Ad- pseudintermedius, Proteus mirabilis, Esch- minister drug with caution to sick or erichia coli, and Enterococcus faecalis debilitated horses. Not for use in and skin and soft tissue infections (wounds and abscesses) in dogs caused horses intended for food. Consult your by susceptible strains of Staphylococcus veterinarian for assistance in the diag- pseudintermedius, Staphylococcus aureus, nosis, treatment, and control of para- coagulase-positive staphylococci, sitism. Pasteurella multocida, Proteus mirabilis, [44 FR 35211, June 19, 1979, as amended at 46 Pseudomonas spp., Klebsiella FR 26301, May 12, 1981; 46 FR 60570, Dec. 11, pneumoniae, E. coli, Enterobacter spp., 1981; 49 FR 28549, July 13, 1984; 61 FR 5506, Citrobacter spp., E. faecalis, b-hemolytic Feb. 13, 1996] streptococci (Group G), and Strepto- coccus equisimilis. § 520.1629 Oxfendazole paste. (2) Cats—(i) Amount. 3.4 mg/lb (7.5 mg/ (a)(1) Specifications. Each gram of kg) of body weight once daily. paste contains 0.375 gram oxfendazole (ii) Indications for use. For the treat- (37.5 percent). ment of skin infections (wounds and (2) Sponsor. See No. 000856 in abscesses) in cats caused by susceptible § 510.600(c) of this chapter. strains of S. aureus, E. coli, and P. (3) Conditions of use—(i) Amount. 10 multocida. milligrams per kilogram (2.2 pounds) of [75 FR 26646, May 12, 2010] body weight. (ii) Indications for use. The drug is § 520.1628 Oxfendazole powder and used in horses for removal of the fol- pellets. lowing gastrointestinal worms: Large (a) Specifications—(1) Powder for sus- roundworms (Parascaris equorum), ma- pension. Each gram of powder contains ture and 4th stage larvae pinworms 7.57 percent oxfendazole. (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. 000856 in (iii) Limitations. Horses maintained § 510.600(c) of this chapter. on premises where reinfection is likely (c) Conditions of use—(1) Amount. 10 milligrams per kilogram of body to occur should be retreated in 6 to 8 weight. weeks. Withholding feed or water prior (2) Indications for use. The drug is to use is unnecessary. Administer drug used in horses for removal of the fol- with caution to sick or debilitated lowing gastrointestinal worms: Large horses. Not for use in horses intended roundworms (Parascaris equorum), ma- for food. Consult your veterinarian for ture and immature pinworms (Oxyuris assistance in the diagnosis, treatment, equi), large strongyles (Strongylus and control of parasitism. edentatus, Strongylus vulgaris, and (b)(1) Specifications. Each gram of Strongylus equinus), and small paste contains 185 milligrams of strongyles. oxfendazole (18.5 percent). (3) Limitations—(i) Powder for suspen- (2) Sponsor. See No. 000856 in sion. For gravity administration via § 510.600(c) of this chapter. stomach tube or for positive adminis- (3) Related tolerances. See § 556.495 of tration via stomach tube and dose sy- this chapter.

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(4) Conditions of use—(i) Amount. 4.5 (Strongylus edentatus, S. vulgaris, and S. milligrams per kilogram of body equinus), and small strongyles. weight (2.05 milligrams per pound). (iii) Limitations. Withholding feed or (ii) Indications for use. The drug is water prior to use is unnecessary. Ad- used in cattle for the removal and con- minister drug with caution to sick or trol of the following worms: lungworms debilitated horses. Do not use in horses (Dictyocaulus viviparus—adult, L4); intended for human consumption. stomach worms: barberpole worms (2) Cattle. Use the products described (Haemonchus contortus and H. placei— in paragraphs (a)(1) and (a)(2) of this adult), small stomach worms section as follows: (Trichostrongylus axei—adult), brown (i) Amount. 4.5 mg/kg of body weight stomach worms (Ostertagia ostertagi— by dose syringe. Treatment may be re- adult, L4, inhibited L4); intestinal peated in 4 to 6 weeks. worms; nodular worms (ii) Indications for use. For the re- (Oesophagostomum radiatum—adult), moval and control of: lungworms hookworms (Bunostomum (Dictyocaulus viviparus—adult, L4); phlebotomum—adult), small intestinal stomach worms: barberpole worms worms (Cooperia punctata, C. oncophora, (Haemonchus contortus and H. placei— and C. mcmasteri—adult, L4); and tape- adult), small stomach worms worms (Moniezia benedeni—adult). (Trichostrongylus axei—adult), brown (iii) Limitations. For use in cattle stomach worms (Ostertagia ostertagi— only. Treatment may be repeated in 4 adult, L4, inhibited L4); intestinal to 6 weeks. Cattle must not be slaugh- worms; nodular worms tered until 11 days after treatment. Do (Oesophagostomum radiatum—adult), 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] 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 [55 FR 46943, Nov. 8, 1990, as amended at 56 (9.06 percent). FR 8710, Mar. 1, 1991; 61 FR 5506, Feb. 13, 1996; (2) 225.0 mg oxfendazole (22.5 percent). 72 FR 10596, Mar. 9, 2007; 73 FR 45610, Aug. 6, (b) Sponsor. See No. 000010 in 2008; 75 FR 10166, Mar. 5, 2010] § 510.600(c) of this chapter. (c) Related tolerances. See § 556.495 of § 520.1631 Oxfendazole and trichlorfon this chapter. paste. (d) Special considerations. See § 500.25 (a) Specifications. Each gram of paste of this chapter. If labeled for adminis- contains 28.5 milligrams oxfendazole tration by stomach tube: Federal law and 454.5 milligrams trichlorfon. restricts this drug to use by or on the (b) Sponsor. See 000856 in § 510.600(c) of order of a licensed veterinarian. this chapter. (e) Conditions of use—(1) Horses. Use (c) Conditions of use—(1) Amount. 2.5 the product described in paragraph milligrams of oxfendazole and 40 milli- (a)(1) of this section as follows: grams of trichlorfon per kilogram of (i) Amount. 10 mg per kilogram (/kg) body weight. of body weight by stomach tube or dose (2) Indications for use. The drug is syringe. Horses maintained on prem- used in horses for removal of bots ises where reinfection is likely to occur (Gasterophilus intestinalis, 2nd and 3rd should be retreated in 6 to 8 weeks. instars; G. nasalis, 3rd instar) and the (ii) Indications for use. For removal of following gastrointestinal worms: large roundworms (Parascaris equorum), Large roundworms (Parascaris mature and 4th stage larvae pinworms equorum), pinworms (Oxyuris equi), (Oxyuris equi), large strongyles adult and 4th stage larvae; large

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strongyles (Strongylus edentatus, S. § 520.1640 Oxibendazole suspension. vulgaris, and S. equinus); and small (a) Specifications. The suspension con- strongyles. tains 10 percent oxibendazole. (3) Limitations. Horses maintained on (b) Sponsor. See 000069 in § 510.600(c) of premises where reinfection is likely to this chapter. occur should be retreated in 6 to 8 (c) Conditions of use in horses—(1) weeks. Withholding feed or water be- Amount. For use other than fore use is unnecessary. Administer threadworms (Strongyloides westeri), 10 with caution to sick or debilitated milligrams of oxibendazole per kilo- horses. Not for use in horses intended gram of body weight; for threadworms, for food. Do not administer to mares 15 milligrams per kilogram of body during the last month of pregnancy. weight. Trichlorfon is a cholinesterase inhib- (2) Indications for use. For removal itor. Do not use this product in ani- and control of large strongyles mals simultaneously with, or within a (Strongylus edentatus, S. equinus, S. few days before or after treatment with vulgaris); small strongyles (species of or exposure to, cholinesterase-inhib- the genera Cylicostephanus Cylicocyclus, iting drugs, pesticides, or chemicals. Cyathostomum, Triodontophorus, Consult your veterinarian for assist- Cylicodontophorus, and Gyalocephalus); ance in the diagnosis, treatment, and large roundworms (Parascaris equorum); control of parasitism. pinworms (Oxyuris equi) including var- [50 FR 50291, Dec. 10, 1985, as amended at 61 ious larval stages; and threadworms FR 5506, Feb. 13, 1996] (Strongyloides westeri). (3) Limitations. Administer by stom- § 520.1638 Oxibendazole paste. ach tube in 3 to 4 pints of warm water, (a) Specifications. The paste contains or by top dressing or mixing into a por- 22.7 percent oxibendazole. tion of the normal grain ration. Pre- (b) Sponsor. See 000069 in § 510.600(c) of pare individual doses to ensure that this chapter. each animal receives the correct (c) Conditions of use in horses—(1) amount. Horses maintained on prem- Amount. For uses other than for ises where reinfection is likely to occur threadworms (Strongyloides westeri), 10 should be re-treated in 6 to 8 weeks. milligrams of oxibendazole per kilo- Not for use in horses intended for gram of body weight; for threadworms human consumption. Federal law re- (Strongyloides westeri), 15 milligrams stricts this drug to use by or on the per kilogram. order of a licensed veterinarian. (2) Indications for use. For removal and control of large strongyles [45 FR 78119, Nov. 28, 1980, as amended at 47 (Strongylus edentatus, S. equinus, S. FR 39812, Sept. 10, 1982; 56 FR 50653, Oct. 8, vulgaris); small strongyles (genera 1991; 60 FR 55659, Nov. 2, 1995; 71 FR 33237, June 8, 2006] Cylicostephanus, Cylicocyclus, Cyathostomum, Triodontophorus, § 520.1660 Oxytetracycline. Cylicodontophorus, and Gyalocephalus); large roundworms (Parascaris equorum); § 520.1660a Oxytetracycline and pinworms (Oxyuris equi) including var- carbomycin in combination. ious larval stages; and threadworms (a) Specifications. (1) Oxytetracycline: (Strongyloides westeri). The antibiotic substance produced by (3) Limitations. Administer orally by growth of Streptomyces rimosus or the syringe. Horses maintained on prem- same antibiotic substance produced by ises where reinfection is likely to occur any other means. should be re-treated in 6 to 8 weeks. (2) Carbomycin: The antibiotic sub- Not for use in horses intended for stance produced by growth of human consumption. Consult a veteri- Streptomyces halstedii or the same anti- narian for assistance in the diagnosis, biotic substance produced by any other treatment, and control of parasitism. means. [46 FR 50948, Oct. 16, 1981, as amended at 47 (b) Sponsor. See No. 000069 in FR 36418, Aug. 20, 1982; 56 FR 50653, Oct. 8, § 510.600(c) of this chapter. 1991; 60 FR 55659, Nov. 2, 1995; 71 FR 33237, (c) Special considerations. The quan- June 8, 2006] tities of oxytetracycline in paragraph

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(e) of this section refer to the activity tinuation of compatible antibiotic of oxytetracycline hydrochloride and therapy following parenteral oxytetra- the quantities of carbomycin listed cycline administration where rapidly refer to the activity of an appropriate attained, sustained antibiotic blood standard. levels are required. The duration of (d) Related tolerances. See §§ 556.110 treatment required to obtain favorable and 556.500 of this chapter. response will depend to some extent on (e) Conditions of use. It is used as oxy- the severity and degree of involvement tetracycline hydrochloride plus and the susceptibility of the infectious carbomycin base in drinking water of agent. Clinical response to antibiotic chickens as follows: therapy usually occurs within 48 to 72 (1) Amount. 1.0 gram of oxytetra- hours. If improvement is not observed cycline and 1.0 gram carbomycin per gallon. within that period, the diagnosis and (2) Indications for use. As an aid in the course of treatment should be reconsid- prevention and treatment of com- ered. To assure adequate treatment, plicated chronic respiratory disease administration of the drug should con- (air-sac infection) caused by Myco- tinue for at least 48 hours following fa- plasma gallisepticum and secondary bac- vorable clinical response.1 terial organisms associated with chron- (3) Federal law restricts this drug to ic respiratory disease such as E. coli. use by or on the order of a licensed vet- (3) Limitations. Administer for not erinarian.1 more than 5 days; not for use in chickens producing eggs for human con- § 520.1660c Oxytetracycline hydro- sumption; withdraw 24 hours before chloride tablets/boluses. slaughter. (a) Specifications. Each tablet or bolus contains 250, 500, or 1,000 milligrams of § 520.1660b Oxytetracycline hydrochloride capsules. oxytetracycline hydrochloride. (b) Sponsors. For sponsors in (a) Specifications. The drug is in cap- § 510.600(c) of this chapter: See 000010 sule form with each capsule containing for use of 500 and 1,000 milligram 125 or 250 milligrams of oxytetracycline boluses. See 000069 for use of 250 and 500 hydrochloride. Oxytetracycline is the milligram tablets. antibiotic substance produced by growth of Streptomyces rimosus or the (c) Tolerances. See § 556.500 of this same antibiotic substance produced by chapter. any other means. (d) Conditions of use in beef and dairy (b) Sponsor. See No. 000069 in cattle—(1)(i) Amount. 250 milligrams per § 510.600(c) of this chapter. 100 pounds of body weight every 12 (c) Conditions of use. (1) It is used in hours (5 milligrams per pound of body dogs and cats for the treatment of bac- weight daily in two doses). terial pneumonia caused by Brucella (ii) Indications for use. For control of bronchiseptica, tonsilitis caused by bacterial enteritis caused by Salmonella Streptococcus hemolyticus, bacterial en- typhimurium and Escherichia coli teritis caused by Escherichia coli, uri- (colibacillosis) and bacterial pneu- nary tract infections caused by Esch- monia (shipping fever complex, erichia coli, and wound infections pasteurellosis) caused by Pasteurella caused by Staphylococcus aureus. 1 multocida. (2) The drug is administered orally to (2)(i) Amount. 500 milligrams per 100 dogs and cats at a dosage level of 25–50 pound of body weight every 12 hours (10 milligrams per pound of body weight milligrams per pound of body weight per day in divided doses at 12-hour in- daily in two doses). tervals. The drug can be used for con- (ii) Indications for use. For treatment of bacterial enteritis caused by Sal- 1 These conditions are NAS/NRC reviewed monella typhimurium and Escherichia coli and deemed effective. Applications for these uses need not include effectiveness data as (colibacillosis) and bacterial pneu- specified by § 514.111 of this chapter, but may monia (shipping fever complex, require bioequivalency and safety informa- pasteurellosis) caused by Pasteurella tion. multocida.

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(3) Limitations. Dosage should con- (9) Each 2.73 grams of powder continue until the animal returns to nor- tains 1 gram of OTC HCl (packets: 9.87 mal and for 24 hours to 48 hours after and, 19.75 oz, and 3.91 lb; pails: 3.09 and symptoms have subsided. Treatment 5 lb). should not exceed 4 consecutive days. (10) Each 2.73 grams of powder con- Do not exceed 500 milligrams per 100 tains 1 gram of OTC HCl (packets: 9.87 pounds of body weight every 12 hours and 19.74 oz; pails: 5 lb). (10 milligrams per pound daily). For (b) Sponsor. See sponsor numbers in sponsor 000069: Discontinue treatment 7 § 510.600(c) of this chapter as follows: days prior to slaughter. Not for use in (1) No. 000069 for use of OTC HCl con- lactating dairy cattle. A withdrawal centrations in paragraphs (a)(1), (a)(2), period has not been established for this and (a)(3) of this section in chickens, product in preruminating calves. Do turkeys, swine, cattle, sheep, and not use in calves to be processed for honey bees. veal. (2) No. 046573 for use of OTC HCl concentration in paragraph (a)(4) of this [46 FR 32440, June 23, 1981, as amended at 50 FR 1045, Jan. 9, 1985; 63 FR 70334, Dec. 21, section in chickens, turkeys, and 1998; 70 FR 16394, Apr. 4, 2005] swine. (3) No. 054628 for use of OTC HCl con- § 520.1660d Oxytetracycline powder. centration in paragraph (a)(5) of this section in turkeys and chickens. (a) Specifications. The drug is a solu- (4) No. 057561 for use of OTC HCl con- ble powder distributed in packets or centration in paragraph (a)(6) of this pails having several concentrations of section in chickens, turkeys, and oxytetracycline hydrochloride (inde- swine. pendent of the various net weights) as (5) No. 061623 for use of OTC HCl con- follows: centration in paragraph (a)(7) of this (1) Each 18.14 grams of powder con- section in chickens, turkeys, swine, tains 1 gram of oxytetracycline hydro- cattle, sheep, and honeybees. chloride (OTC HCl) (packets: 4, 6.4, and (6) No. 048164 for use of OTC HCl con- 16 oz.). centrations in paragraph (a)(8) of this (2) Each 4.43 grams of powder con- section in chickens, turkeys, swine, tains 1 gram of OTC HCl (packets: 4 cattle, sheep, and honey bees. and 16 oz.). (7) No. 061623 for use of OTC HCl con- (3) Each 1.32 grams of powder concentration in paragraph (a)(9) of this tains 1 gram of OTC HCl (packets: 2.39, section in chickens, turkeys, and 4.78, and 9.55 oz.; jars: 2.25 lbs.; and swine. pails: 4.5 lbs.). (8) No. 059320 for use of OTC con- (4) Each 2.73 grams of powder concentration in paragraph (a)(10) of this tains 1 gram of OTC HCl (packets: 2.46 section in chickens, turkeys, and swine and 9.87 oz; pail: 3.09 lb). as in paragraph (d) of this section. (5) Each 4.2 grams of powder contains (c) Related tolerances. See § 556.500 of 1 gram of OTC HCl (packets: 3.8 and this chapter. 15.2 oz; pails: 4.74 and 23.7 lb). (d) Conditions of use. (1) It is used in (6) Each 1.32 grams of powder con- drinking water as follows: tains 1 gram of OTC HCl (packet: 4.78 (i) Chickens—(A)(1) Amount per gallon. oz.; pail: 5 lb). Each 2.73 grams of pow- 200 to 400 milligrams. der contains 1 gram of OTC HCl (pack- (2) Indications for use. Control of in- et: 9.87 oz). fectious synovitis caused by Myco- (7) Each 1.32 grams of powder con- plasma synoviae susceptible to oxytet- tains 1 gram of OTC HCl (packet: 4.78 racycline. and 9.6 oz.; pails: 2 and 5 lb); each 18.1 (3) Limitations. Prepare a fresh solu- grams of powder contains 1 gram of tion daily. Administer 7 to 14 days. Not OTC HCl (packet: 6.4 oz.; pails: 2 and 5 to be used for more than 14 consecutive lb). days. Use as sole source of drinking (8) Each 135.5-gram packet (4.78 water. Do not use in birds producing ounce) contains 102.4 grams of OTC eggs for human consumption. HCl. Each 677.5-gram packet (23.9 (B)(1) Amount per gallon. 400 to 800 ounce) contains 512 grams of OTC HCl. milligrams.

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(2) Indications for use. Control of (transmissible enteritis, coronaviral chronic respiratory disease (CRD) and enteritis) susceptible to oxytetra- air sac infections caused by Myco- cycline. plasma gallisepticum and E. coli suscep- (3) Limitations. Prepare a fresh solu- tible to oxytetracycline; control of tion daily. Administer 7 to 14 days. Not fowl cholera caused by Pasteurella to be used for more than 14 consecutive multocida susceptible to oxytetra- days. Use as sole source of drinking cycline. water. Do not use in birds producing (3) Limitations. Prepare a fresh solu- eggs for human consumption. With- tion daily. Administer 7 to 14 days. Not draw 5 days prior to slaughter those to be used for more than 14 consecutive products sponsored by Nos. 000069, and days. Use as sole source of drinking 061623 in § 510.600(c) of this chapter. water. Do not use in birds producing Withdraw 4 days prior to salughter eggs for human consumption. those products sponsored by No. 054628. (ii) Turkeys—(A)(1) Amount per gallon. Zero-day withdrawal for those products 200 to 400 milligrams. sponsored by Nos. 046573, 053389, 057561, (2) Indications for use. Control of 059320, and 061133. hexamitiasis caused by Hexamita (iii) Swine—(A) Amount. 10 milligrams meleagridis susceptible to oxytetra- per pound of body weight daily. cycline. (B) Indications for use. Control and (3) Limitations. Prepare a fresh solu- treatment of bacterial enteritis caused tion daily. Administer 7 to 14 days. Not by Escherichia coli and Salmonella to be used for more than 14 consecutive choleraesuis and bacterial pneumonia days. Use as sole source of drinking caused by Pasteurella multocida suscep- water. Do not use in birds producing tible to oxytetracycline. For breeding eggs for human consumption. With- swine: Control and treatment of lepto- draw 5 days prior to slaughter those spirosis (reducing the incidence of products sponsored by Nos. 000069, and abortions and shedding of leptospira) 061623 in § 510.600(c) of this chapter. caused by Leptospira pomona suscep- Withdraw 4 days prior to slaughter tible to oxytetracycline. those products sponsored by No. 054628. (C) Limitations. Prepare a fresh solu- Zero-day withdrawal for those products tion daily. Use as sole source of OTC. sponsored by Nos. 046573, 053389, 057561, Administer up to 14 days; do not use for 059320, and 061133. more than 14 consecutive days; with- (B)(1) Amount per gallon. 400 milli- draw zero days prior to slaughter those grams. products sponsored by Nos. 000069 and (2) Indications for use. Control of in- 061623. Administer up to 5 days; do not fectious synovitis caused by Myco- use for more than 5 consecutive days; plasma synoviae susceptible to oxytet- withdraw zero days prior to slaughter racycline. those products sponsored by Nos. (3) Limitations. Prepare a fresh solu- 046573, 053389, 057561, 059320, and 061133. tion daily. Administer 7 to 14 days. Not (iv) Calves, beef cattle, and nonlac- to be used for more than 14 consecutive tating dairy cattle—(A) Amount. 10 milli- days. Use as sole source of drinking grams per pound of body weight daily. water. Do not use in birds producing (B) Indications for use. Control and eggs for human consumption. With- treatment of bacterial enteritis caused draw 5 days prior to slaughter those by E. coli and bacterial pneumonia products sponsored by Nos. 000069, and (shipping fever complex) caused by P. 061623 in § 510.600(c) of this chapter. multocida susceptible to oxytetra- Withdraw 4 days prior to slaughter cycline. those products sponsored by No. 054628. (C) Limitations. Prepare a fresh solu- Zero-day withdrawal for those products tion daily. Administer up to 14 days. sponsored by Nos. 046573, 053389, 057561, Do not use for more than 14 consecu- 059320, and 061133. tive days. Use as sole source of oxytet- (C)(1) Amount. 25 milligrams per racycline. Do not administer this prod- pound of body weight. uct with milk or milk replacers. Ad- (2) Indications for use. Growing tur- minister 1 hour before or 2 hours after keys. Control of complicating bacterial feeding milk or milk replacers. With- organisms associated with bluecomb draw 5 days prior to slaughter. A milk

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discard period has not been established (c) Conditions of use in turkeys— (1) for this product in lactating dairy cat- Amount. 1,500,000 units per gallon tle. Do not use in female dairy cattle 20 drinking water for 5 days. months of age or older. (2) Indications for use. Treatment of (v) Sheep—(A) Amount. 10 milligrams erysipelas caused by Erysipelothrix per pound of body weight daily. rhusiopathiae. (B) Indications for use. Control and (3) Limitations. Prepare concentrated treatment of bacterial enteritis caused stock solution for use with medication by E. coli and bacterial pneumonia proportioners fresh every 24 hours. Pre- (shipping fever complex) caused by P. pare recommended use levels for grav- multocida susceptible to oxytetra- ity flow watering system fresh every 12 cycline. hours. For best results, treatment (C) Limitations. Prepare a fresh solu- should be started at the first sign of in- tion daily. Administer up to 14 days. fection. Discontinue treatment at least Do not use for more than 14 consecu- 1 day prior to slaughter. Not for use in tive days. Use as sole source of oxytet- turkeys producing eggs for human con- racycline. Withdraw 5 days prior to sumption. slaughter. [57 FR 37326, Aug. 18, 1992, as amended at 59 (2) It is used in the food of honey bees FR 42493, Aug. 18, 1994; 60 FR 26359, May 17, as follows: 1995; 62 FR 55160, Oct. 23, 1997; 65 FR 10705, (i) Amount. 200 milligrams per colony, Feb. 29, 2000; 66 FR 14073, Mar. 9, 2001; 68 FR administered via either a 1:1 sugar 4914, Jan. 31, 2003; 68 FR 26204, May 15, 2003; syrup (equal parts of sugar and water 69 FR 9946, Mar. 3, 2004; 69 FR 41428, July 9, weight to weight) or dusting with a 2004; 77 FR 20988, Apr. 9, 2012] powdered sugar mixture. § 520.1696c Penicillin V powder. (ii) Indications for use. For control of American foulbrood caused by (a) Specifications. When reconstituted, Paenibacillus larvae and European each milliliter contains 25 milligrams foulbrood caused by Streptococcus (40,000 units) of penicillin V. pluton susceptible to oxytetracycline. (b) Sponsor. See No. 050604 in (iii) Limitations. The drug is adminis- § 510.600(c) of this chapter. tered in 3 applications of sugar syrup (c) [Reserved] or 3 dustings at 4- to 5-day intervals. (d) Conditions of use. Dogs and cats— The drug should be fed early in the (1) Amount. 10 to 15 milligrams per spring or fall and consumed by the bees pound of body weight every 6 to 8 before main honey flow begins to avoid hours. contamination of production honey. (2) Indications for use. Treatment of Remove at least 6 weeks prior to main respiratory, urogenital, skin, and soft honey flow. tissue infections and septicemia caused by pathogens susceptible to penicillin [50 FR 32694, Aug. 14, 1985] V potassium. EDITORIAL NOTE: For FEDERAL REGISTER ci- (3) Limitations. Administer orally 1 to tations affecting § 520.1660d, see the List of 2 hours prior to feeding for maximum CFR Sections Affected, which appears in the absorption. 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. § 520.1696 Penicillin. [57 FR 37326, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 77 FR 20988, Apr. 9, 2012] § 520.1696a [Reserved] § 520.1696d Penicillin V tablets. § 520.1696b Penicillin G powder. (a) Specifications. Each tablet con- (a) Specifications. Each gram of pow- tains penicillin V potassium equivalent der contains penicillin G potassium to 125 milligrams (200,000 units) or 250 equivalent to 1.54 million units of peni- milligrams (400,000 units) of penicillin cillin G. V. (b) Sponsors. See Nos. 010515, 046573, (b) Sponsors. See Nos. 050604 and 053501, 059320, 061623 and 076475 in 053501 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) [Reserved]

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(d) Conditions of use. Dogs and Cats— (5) No. 000143 for use of 1-g tablets in (1) Amount. 10 to 15 milligrams per horses. pound of body weight every 6 to 8 (6) No. 058829 for use of 100-mg or 1-g hours. tablets in dogs and horses. (2) Indications for use. Treatment of (c) Conditions of use—(1) Dogs—(i) respiratory, urogenital, skin and soft Amount. 20 mg per pound of body tissue infections and septicemia caused weight daily. by pathogens susceptible to penicillin (ii) Indications for use. For the relief V potassium. of inflammatory conditions associated (3) Limitations. Administer orally 1 to with the musculoskeletal system. 2 hours prior to feeding for maximum absorption. Federal law restricts this (iii) Limitations. Federal law restricts drug to use by or on the order of a li- this drug to use by or on the order of a censed veterinarian. licensed veterinarian. (2) Horses—(i) Amount. 1 to 2 g per 500 [57 FR 37327, Aug. 18, 1992, as amended at 59 pounds of body weight daily. FR 58775, Nov. 15, 1994] (ii) Indications for use. For the relief § 520.1705 Pergolide. of inflammatory conditions associated with the musculoskeletal system. (a) Specifications. Each tablet contains 1 milligram (mg) pergolide (iii) Limitations. Do not use in horses mesylate. intended for human consumption. Fed- (b) Sponsor. See No. 000010 in eral law prohibits the use of this drug § 510.600(c) of this chapter. in female dairy cattle 20 months of age (c) Conditions of use in horses—(1) or older. Federal law restricts this drug Amount. Administer orally at a start- to use by or on the order of a licensed ing dose of 2 micrograms/kilograms (μ/ veterinarian. kg) once daily. Dosage may be adjusted [73 FR 8192, Feb. 13, 2008, as amended at 74 to effect, not to exceed 4 μg/kg daily. FR 1146, Jan. 12, 2009; 76 FR 11331, Mar. 2, (2) Indications for use. For the control 2011; 76 FR 17777, Mar. 31, 2011; 78 FR 21060, of clinical signs associated with Pitui- Apr. 9, 2013] tary Pars Intermedia Dysfunction (Equine Cushing’s Disease). § 520.1720b Phenylbutazone granules. (3) Limitations. Federal law restricts (a) Specifications. The drug is in this drug to use by or on the order of a granular form. It is packaged to con- licensed veterinarian. tain either 8 grams of phenylbutazone [77 FR 15960, Mar. 19, 2012] per package or 1 gram of phenylbutazone per package. § 520.1720 Phenylbutazone oral dosage (b) Sponsor. See 000061 in § 510.600(c) forms. for 8-gram package, see 059320 for 1- gram package. § 520.1720a Phenylbutazone tablets and boluses. (c) NAS/NRC status. The conditions of use have been NAS/NRC reviewed and (a) Specifications. Each tablet con- found effective. NADA’s for approval of tains 100, 200, or 400 milligrams (mg), or drugs for these conditions of use need 1 gram (g) of phenylbutazone. Each not include effectiveness data specified bolus contains 1, 2, or 4 gram g of by § 514.111 of this chapter, but may re- phenylbutazone. quire bioequivalency and safety infor- (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter, as follows: mation. (1) No. 000061 for use of 100- or 400-mg (d) Conditions of use—(1) Horses—(i) or 1-g tablets, or 2- or 4-g boluses, in Amount. 1 to 2 grams per 500 pounds of dogs and horses. body weight, not to exceed 4 grams, (2) Nos. 000859 and 054628 for use of daily, as required. 100- or 200-mg or 1-g tablets in dogs and (ii) Indications. For the treatment of horses. inflammatory conditions associated (3) Nos. 000856 and 061623 for use of with the musculoskeletal system. 100-mg or 1-g tablets in dogs and (iii) Limitations. Administer orally by horses. adding to a portion of the usual grain (4) [Reserved] ration. Use a relatively high dose for

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the first 48 hours, then gradually re- may require bioequivalency and safety duce to a maintenance level at the low- information. est level capable of producing the de- (d) Conditions of use in horses—(1) sired clinical response. Treated ani- Amount. 1 to 2 grams of phenylbutazone mals should not be slaughtered for food per 500 pounds of body weight, not to use. Federal law restricts this drug to exceed 4 grams daily. use by or on the order of a licensed vet- (2) Indications for use. For relief of in- erinarian. flammatory conditions associated with [46 FR 18960, Mar. 27, 1981, as amended at 46 the musculoskeletal system of horses. FR 48642, Oct. 2, 1981; 57 FR 2836, Jan. 24, 1992; (3) Limitations. Use a relatively high 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, dose for the first 48 hours, then gradu- 1997; 65 FR 20731, Apr. 18, 2000] ally reduce to a maintenance level at the lowest level capable of producing § 520.1720c Phenylbutazone paste. the desired clinical response. Not for (a) Specifications—(1) Each gram of use in horses intended for food. Federal paste contains 0.2 grams law restricts this drug to use by or on phenylbutazone. the order of a licensed veterinarian. (2) Each gram of paste contains 0.35 [50 FR 13561, Apr. 5, 1985, as amended at 50 grams phenylbutazone. FR 49372, Dec. 2, 1985; 55 FR 8462, Mar. 8, 1990; (b) Sponsors. See sponsor numbers in 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, § 510.600(c) of this chapter. 2003] (1) No. 000061 for use of product described in paragraph (a)(1) of this sec- § 520.1720e Phenylbutazone powder. tion. (a) Specifications—(1) Each 1.15 grams (2) No. 064847 for use of product de- (g) of powder contains 1 g scribed in paragraph (a)(2) of this sec- phenylbutazone. tion. (2) Each 10 g of powder contains 1 g (c) Conditions of use in horses—(1) phenylbutazone. Amount. 1 to 2 grams of phenylbutazone (b) Sponsors. See sponsor numbers in per 500 pounds of body weight, not to § 510.600(c) of this chapter. exceed 4 grams daily. (1) No. 027053 for use of product de- (2) Indications for use. For relief of in- scribed in paragraph (a)(1) of this sec- flammatory conditions associated with tion. the musculoskeletal system. (2) No. 057699 for use of product de- (3) Limitations. Use a relatively high scribed in paragraph (a)(2) of this sec- dose for the first 48 hours, then gradu- tion. ally reduce to a maintenance level of (c) Conditions of use in horses—(1) the lowest level capable of producing Amount. Administer 1 to 2 g (1 to 2 level the desired clinical response. Do not scoops, using the scoop provided) per use in horses intended for human con- 500 pounds of body weight on a small sumption. Federal law restricts this amount of palatable feed, not exceed 4 drug to use by or on the order of a li- g per animal daily. censed veterinarian. (2) Indications for use. For the relief of [45 FR 84762, Dec. 23, 1980, as amended at 58 inflammatory conditions associated FR 29777, May 24, 1993; 61 FR 8873, Mar. 6, with the musculosketetal system. 1996; 62 FR 61625, Nov. 19, 1997; 68 FR 43926, (3) Limitations. Do not use in horses July 25, 2003; 72 FR 60550, Oct. 25, 2007; 77 FR intended for human consumption. Fed- 4897, Feb. 1, 2012] eral law prohibits the extralabel use of § 520.1720d Phenylbutazone gel. this product in female cattle 20 months of age or older. Federal law restricts (a) Specifications. Each 30 grams of gel this drug to use by or on the order of a contains 4 grams of phenylbutazone. licensed veterinarian. (b) Sponsor. See No. 061623 in § 510.600(c) of this chapter. [72 FR 27956, May 18, 2007] (c) NAS/NRC status. The conditions of use are NAS/NRC reviewed and found § 520.1760 Phenylpropanolamine. effective. Applications for these uses (a) Specifications. Each chewable tab- need not include effectiveness data as let contains 25, 50, or 75 milligram (mg) specified in § 514.111 of this chapter, but phenylpropanolamine hydrochloride.

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(b) Sponsors. See No. 055246 in (c) Conditions of use. Horses and § 510.600(c) of this chapter. ponies—(1) Amount. One fluid ounce per (c) Conditions of use in dogs—(1) 100 pounds of body weight.1 Amount. Administer 2 mg/kg of body (2) Indications for use. For removing weight twice daily. ascarids (large roundworms, Parascaris (2) Indications for use. For the control equorum), bots (Gastrophilus spp.), small of urinary incontinence due to urethral strongyles, large strongyles (Strongyles sphincter hypotonus in dogs. spp.), and pinworms (Oxyuris equi).1 (3) Limitations. Federal law restricts (3) Limitations. Administer by stom- this drug to use by or on the order of a ach tube or dose syringe after with- licensed veterinarian. holding feed overnight or for 8 to 10 hours. Provide water as usual. Resume [77 FR 15961, Mar. 19, 2012] regular feeding 4 to 6 hours after treat- § 520.1780 Pimobendan. ment. Treatment of debilitated or anemic animals is contraindicated. Do not (a) Specifications. Each chewable tab- administer to animals that are or were let contains 1.25, 2.5, 5, or 10 milligrams recently affected with colic, diarrhea, (mg) pimobendan. or infected with a serious infectious (b) Sponsor. See No. 000010 in disease. As with most anthelmintics, § 510.600(c) of this chapter. drastic cathartics and other gastro- (c) Conditions of use in dogs—(1) intestinal irritants should not be ad- Amount. Administer orally at a total ministered in conjunction with this daily dose of 0.23 mg per pound (0.5 mg drug. Animals in poor condition or per kilogram) body weight, using a heavily parasitized should be given one suitable combination of whole or half half the recommended dose and treated tablets. The total daily dose should be again in 2 or 3 weeks. Federal law re- divided into two portions administered stricts this drug to use by or on the approximately 12 hours apart. order of a licensed veterinarian.1 (2) Indications for use. For the management of the signs of mild, mod- [45 FR 52781, Aug. 8, 1980] erate, or severe (modified New York Heart Association Class II, III, or IV) § 520.1802b Piperazine-carbon disulfide complex boluses. congestive heart failure due to atrio- ventricular valvular insufficiency or (a) Specifications. Each bolus contains dilated cardiomyopathy; for use with 20 grams of piperazine-carbon disulfide concurrent therapy for congestive complex. heart failure as appropriate on a case- (b) Sponsor. See 000009 in § 510.600(c) of by-case basis. this chapter. (3) Limitations. Federal law restricts (c) Conditions of use: Horses and this drug to use by or on the order of a ponies—(1) Amount. For removal of licensed veterinarian. ascarids and small strongyles, 1 bolus (20 grams) per 500 pounds body weight; [72 FR 27733, May 17, 2007, as amended at 79 removal of large strongyles, pinworms, FR 18158, Apr. 1, 2014] and bots, 1 bolus per 250 pounds body weight.1 § 520.1802 Piperazine-carbon disulfide complex oral dosage forms. (2) Indications for use. For removing ascarids (large roundworms, Parascaris § 520.1802a Piperazine-carbon disul- equorum), large strongyles (Strongylus fide complex suspension. spp.) bots (Gastrophilus spp.), small (a) Specifications. Each fluid ounce of strongyles, and pinworms (Oxyuris 1 suspension contains 7.5 grams of piper- equi). azine-carbon disulfide complex. The pi- (3) Limitations. Withhold feed over- perazine-carbon disulfide complex con- night or for 8 to 10 hours. Give water tains equimolar parts of piperazine and carbon disulfide (1 gram contains 530 1 These conditions are NAS/NRC reviewed mgs of piperazine and 470 mgs of carbon and found effective. Applications for these disulfide). uses need not include effectiveness data as specified by § 514.111 of this chapter, but may (b) Sponsor. See 000009 in § 510.600(c) of require bioequivalency and safety informa- this chapter. tion.

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just before and/or after treatment. Re- the animal has finished eating the sume regular feeding 4 to 6 hours after dosed food, the remainder of the food treatment. Treatment of debilitated or may be given. Dogs and cats may be anemic animals is contraindicated. Do wormed at 6 to 8 weeks of age. The first not administer to animals that are or treatment should be repeated 10 days were recently affected with colic, diar- later. Reinfection may occur. Repeat rhea, or infected with a serious infec- treatment if indicated. tious disease. As with most (3) Severely debilitated animals anthelmintics, drastic cathartics or should not be wormed except on the ad- other gastrointestinal irritants should vice of a veterinarian. not be administered in conjunction with this drug. Animals in poor condi- [40 FR 13838, Mar. 27, 1975, as amended at 54 FR 38515, Sept. 19, 1989] tion or heavily parasitized should be given one half the recommended dose § 520.1804 Piperazine phosphate cap- and treated again in 2 or 3 weeks. Con- sules. sult your veterinarian for assistance in the diagnosis, treatment, and control (a) Specifications. Each capsule contains 120, 300, or 600 milligrams of pi- of parasitism.1 perazine phosphate monohydrate. [45 FR 52782, Aug. 8, 1980] (b) Sponsor. See No. 051311 in § 510.600(c) of this chapter. § 520.1802c Piperazine-carbon disul- (c) Conditions of use—(1) Amount. 60 fide complex with phenothiazine suspension. milligrams of piperazine phosphate monohydrate per pound of body (a) Specifications. Each fluid ounce weight.1 contains 5 grams of piperazine-carbon (2) Indications for use—(i) Dogs. It is disulfide complex and 0.83 gram of used for the removal of large phenothiazine. roundworms (ascarids) Toxocara canis (b) Sponsor. See 000009 in § 510.600(c) of and Toxascaris leonina. 1 this chapter. (ii) Cats. It is used for the removal of (c) Conditions of use: Horses and large roundworms (ascarids) Toxocara ponies—(1) Amount. One fluid ounce per mystax and Toxacaris leonina. 1 100 pounds of body weight. (3) Limitations. Administer in ani- (2) Indications for use. For removing mal’s food or milk. For animals up to ascarids (large roundworms, Parascaris 1 year of age administer every 2 or 3 equorum), bots (Gastrophilus spp.), small months; for animals over 1 year old, strongyles, and large strongyles administer periodically as necessary. (Strongylus spp.). Consult your veterinarian for assist- (3) Limitations. See § 520.1802a(c)(3). ance in the diagnosis, treatment, and [45 FR 52782, Aug. 8, 1980] control of parasitism.1

§ 520.1803 Piperazine citrate capsules. [43 FR 6941, Feb. 17, 1978; 43 FR 9804, Mar. 10, 1978, as amended at 46 FR 20158, Apr. 3, 1981; (a) Specifications. Piperazine citrate 69 FR 31878, June 8, 2004] capsules contain piperazine citrate equivalent to 140 milligrams of piper- § 520.1805 Piperazine phosphate with azine base in each capsule. thenium closylate tablets. (b) Sponsor. See No. 021091 in (a) Specifications. Each scored tablet § 510.600(c) of this chapter. contains the equivalent of 250 milli- (c) Conditions of use. (1) It is used in grams piperazine hexahydrate (as pi- dogs and cats for the removal of large perazine phosphate) and 125 milligrams roundworms (Toxocara canis and thenium (as thenium closylate) or 500 Toxascaris leonina). milligrams piperazine hexahydrate (as (2) The contents of 1 capsule should be mixed with the food of the animal 1 for each 5 pounds, or fraction thereof of These conditions are NAS/NRC reviewed and deemed effective. Applications for these body weight, except dogs weighing over uses need not include effectiveness data as 25 pounds should be given the contents specified by § 514.111 of this chapter, but may of 6 capsules. The drug should be mixed require bioequivalency and safety informa- in 1⁄2 of the regular feeding and when tion.

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piperazine phosphate) and 250 milli- (2) Dosage. Administer 20 to 30 mg pi- grams thenium (as thenium closylate). perazine base per pound body weight as (b) Sponsor. See No. 000061 in a single dose. § 510.600(c) of this chapter. (3) Limitations. Administer by mixing (c) Conditions of use—(1) Amount. Ad- into the animal’s ration to be con- minister orally to dogs as follows: sumed at one feeding. For animals in heavily contaminated areas, reworm at NUMBER OF TABLETS AT EACH OF THE TWO monthly intervals. Not for use in DOSES unweaned pups or animals less than 3 weeks of age. Animal weight (lb) 375 mg 750 mg [70 FR 17319, Apr. 6, 2005]

2 but less than 5 ...... 1⁄2 ...... 5 but less than 10 ...... 1 1⁄2 § 520.1807 Piperazine. 10 or heavier ...... 2 1 (a) Specifications. A soluble powder or liquid containing piperazine (2) Indications for use. For removal of dihydrochloride or dipiperazine sulfate, immature (fourth stage larvae) and equivalent to 17, 34, or 230 grams of pi- adult hookworms (Ancylostoma perazine per pound or 100 milliliters. caninum, A. braziliense, and Uncinaria (b) Sponsor. See 015565 in § 510.600(c) of stenocephala) and ascarids (Toxocara this chapter. canis) from weaned pups and adult (c) Related tolerances. See § 556.513 of dogs. this chapter. (3) Limitations. Do not use this prod- (d) Conditions of use—(1) Chickens—(i) uct to treat dogs weighing less than 2 Amount. 50 milligrams per bird under 6 pounds, unweaned pups, or pups under 5 weeks, 100 milligrams per bird over 6 weeks of age. Maximum efficacy weeks. against hookworms necessitates two (ii) Indications for use. For removal of doses in 1 day of treatment. The inter- large roundworm (Ascaridia spp.). val between the doses should be not (iii) Limitations. For use in drinking less than 4 hours or more than 24 water or feed. Use as sole source of hours. Administer the first dose in the drinking water. Prepare fresh solution morning before feeding. Do not permit daily. Use as 1-day single treatment. dog to chew tablet. Feed the dog be- Withdraw 14 days prior to slaughter. tween doses. Do not feed milk or other Do not use for chickens producing eggs fatty foods during treatment. Retreat- for human consumption. Consult your ment may be needed in 7 to 28 days as veterinarian for assistance in the diag- determined by laboratory fecal exami- nosis, treatment, and control of para- nations or in animals kept in known sitism. contaminated quarters. Federal law re- (2) Turkeys—(i) Amount. 100 milli- stricts this drug to use by or on the grams per bird up to 12 weeks and 200 order of a licensed veterinarian. milligrams per bird over 12 weeks. (ii) Indications for use. For removal of [43 FR 32747, July 28, 1978, as amended at 47 large roundworm (Ascaridia spp.). FR 55476, Dec. 10, 1982; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997] (iii) Limitations. For use in drinking water or feed. Use as sole source of § 520.1806 Piperazine suspension. drinking water. Prepare fresh solution daily. Use as 1-day single treatment. (a) Specifications. Each milliliter of Withdraw 14 days prior to slaughter. suspension contains piperazine Consult your veterinarian for assist- monohydrochloride equivalent to 33.5 ance in the diagnosis, treatment, and milligrams (mg) piperazine base. control of parasitism. (b) Sponsor. See No. 017135 in (3) Swine—(i) Amount. 50 milligrams § 510.600(c) of this chapter. per pound of body weight. (c) Special considerations. See (ii) Indications for use. For removal of § 500.25(c) of this chapter. large roundworm (Ascaris suum) and (d) Conditions of use in dogs—(1) Indi- nodular worms (Oesophagostomum spp.). cations for use. For the removal of (iii) Limitations. For use in drinking roundworms (Toxocara canisand water or feed. Use as sole source of Toxascaris leonina). drinking water. Prepare fresh solution

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daily. Use as 1-day single treatment. blocks at least 7 days before exposure Withdraw 21 days prior to slaughter. to bloat-producing conditions. Consult your veterinarian for assist- [40 FR 13838, Mar. 27, 1975, as amended at 40 ance in the diagnosis, treatment, and FR 39857, Aug. 29, 1975; 42 FR 41854, Aug. 19, control of parasitism. 1977; 50 FR 5385, Feb. 8, 1985; 54 FR 33501, Aug. [64 FR 23018, Apr. 29, 1999] 15, 1989; 56 FR 50653, Oct. 8, 1991; 58 FR 26523, May 4, 1993; 60 FR 55659, Nov. 2, 1995; 66 FR § 520.1840 Poloxalene. 47963, Sept. 17, 2001; 69 FR 62811, Oct. 28, 2004; 70 FR 32489, June 3, 2005] (a) Specifications. Polyoxypropylene- polyoxyethylene glycol nonionic block § 520.1846 Polyoxyethylene (23) lauryl polymer. ether blocks. (b) Sponsors. See sponsors in (a) Specifications. Each molasses- § 510.600(c) of this chapter for use as in based block contains 2.2 percent paragraph (d) of this section. polyoxyethylene (23) lauryl ether. (1) No. 000069 for use as in paragraphs (b) Sponsor. See No. 067949 in (d)(1) and (d)(3) of this section. § 510.600(c) of this chapter. (2) No. 051311 for use as in paragraph (c) Conditions of use—(1) Amount. 2 (d)(4) of this section. grams of polyoxyethylene (23) lauryl (3) No. 067949 for use as in paragraph ether per 100 kilograms of body weight (d)(2) of this section. per day (1 pound of block per 500 kilo- (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. 000859 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. 5 mg per kilogram body producing conditions for more than 12 weight, daily for 28 days. hours after the last treatment. Do not (2) Indications for use. For the treat- exceed the double dose in any 24-hour ment of equine protozoal period. myeloencephalitis caused by Sarcocystis (4) For control of legume (alfalfa, clo- neurona. ver) and wheat pasture bloat in cattle. (3) Limitations. Not for use in horses Administer in molasses block con- intended for food. Federal law restricts taining 6.6 percent poloxalene, at the this drug to use by or on the order of a rate of 0.8 ounce of block (1.5 grams of licensed veterinarian. poloxalene) per 100 pounds of body weight per day. Provide access to [66 FR 43774, Aug. 21, 2001]

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§ 520.1860 Pradofloxacin. (iii) Limitations—(A) If labeled only for use as in paragraph (c)(1)(ii)(A) of (a) Specifications. Each milliliter of suspension contains 25 milligrams (mg) this section: Not intended for use in pradofloxacin. puppies less than 4 weeks of age. Con- sult your veterinarian before admin- (b) Sponsor. See No. 000859 in § 510.600(c) of this chapter. istering tablets to weak or debilitated animals and for assistance in the diag- (c) Special considerations. Federal law restricts this drug to use by or on the nosis, treatment, and control of para- order of a licensed veterinarian. Fed- sitism. (B) If labeled for use as in paragraph eral law prohibits the extralabel use of (c)(1)(ii)(B) of this section: Federal law this drug in food-producing animals. restricts this drug to use by or on the (d) Conditions of use in cats—(1) order of a licensed veterinarian. Amount. Administer 3.4 mg/lb (7.5 mg/ (2) Cats—(i) Indications for use. For re- kg) body weight once daily for 7 con- moval of feline cestodes Dipylidium secutive days. caninum and Taenia taeniaeformis. (2) Indications for use. For the treat- (ii) Dosage. Cats 4 pounds and under, ment of skin infections (wounds and 11.5 mg; 5 to 11 pounds, 23 mg; over 11 abscesses) in cats caused by susceptible pounds, 34.5 mg. strains of Pasteurella multocida, Strepto- (iii) Limitations. Administer directly coccus canis, Staphylococcus aureus, by mouth or crumbled and in feed. Not Staphylococcus felis, and Staphylococcus intended for use in kittens less than 6 pseudintermedius. weeks of age. For OTC use: Consult [77 FR 76863, Dec. 31, 2012] your veterinarian before administering tablets to weak or debilitated animals, § 520.1870 Praziquantel tablets. and for assistance in the diagnosis, (a) Specifications. Each tablet con- treatment, and control of parasitism. tains: [46 FR 60570, Dec. 11, 1981, as amended at 47 (1) 34 milligrams (mg) praziquantel. FR 26377, June 18, 1982; 55 FR 2234, Jan. 23, (2) 11.5 or 23 mg praziquantel. 1990; 58 FR 7864, Feb. 10, 1993; 58 FR 42853, (b) Sponsors. See sponsors in Aug. 12, 1993; 68 FR 57351, Oct. 3, 2003; 69 FR § 510.600(c) of this chapter: 62181, Oct. 25, 2004; 78 FR 17596, Mar. 22, 2013] (1) No. 000859 for use of the product described in paragraph (a)(1) of this § 520.1871 Praziquantel and pyrantel. section, as in paragraph (c)(1) of this (a) Specifications. (1) Each tablet con- section; and for use of the product de- tains 13.6 milligrams (mg) praziquantel scribed in paragraph (a)(2) of this sec- and 54.3 mg pyrantel base (as pyrantel tion, as in paragraph (c)(2) of this sec- pamoate), 18.2 mg praziquantel and 72.6 tion. mg pyrantel base (as pyrantel (2) No. 000859 for use of the product pamoate), or 27.2 mg praziquantel and described in paragraph (a)(1) of this 108.6 mg pyrantel base (as pyrantel section, as in paragraph (c)(1) of this pamoate). section. (2) Each chewable tablet contains 30 (c) Conditions of use—(1) Dogs—(i) mg praziquantel and 30 mg pyrantel Amount. 5 pounds (lb) and under, 1⁄2 tab- pamoate or 114 mg praziquantel and 114 let (17 mg); 6 to 10 lb, 1 tablet (34 mg); mg pyrantel pamoate. 11 to 15 lb, 11⁄2 tablets (51 mg); 16 to 30 (b) Sponsors. See sponsors in lb, 2 tablets (68 mg); 31 to 45 lb, 3 tab- § 510.600(c) for use as in paragraph (d) of lets (102 mg); 46 to 60 lb, 4 tablets (136 this chapter. mg); over 60 lb, 5 tablets maximum (170 (1) See No. 000859 for use of tablets mg). Administer directly by mouth or described in paragraph (a)(1) of this crumbled and in feed. section for use as in paragraph (d)(1) of (ii) Indications for use—(A) For re- this section. moval of canine cestodes Dipylidium (2) See No. 051311 for use of tablets caninum and Taenia pisiformis. described in paragraph (a)(2) of this (B) For removal of the canine cestode section for use as in paragraph (d)(2) of Echinococcus granulosus, and for re- this section. moval and control of the canine (c) Special considerations. See § 500.25 cestode Echinococcus multilocularis. of this chapter.

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(d) Conditions of use—(1) Cats—(i) Dos- Weight of animal Number of tablets per dose age. Administer a minimum dose of 2.27 Tablet Tablet Tablet mg praziquantel and 9.2 mg pyrantel Kilograms Pounds no. 1 no. 2 no. 3 pamoate per pound of body weight ac- 0.9 to 1.8 ...... 2 to 4 ...... 1/2. cording to the dosing tables on label- 2.3 to 3.2 ...... 5 to 7 ...... 1. ing. May be given directly by mouth or 3.6 to 5.4 ...... 8 to 12 ..... 1 1/2. in a small amount of food. Do not with- 5.9 to 8.2 ...... 13 to 18 ... 2. 8.6 to 11.4 .... 19 to 25 ... 2 1/2. hold food prior to or after treatment. If 11.8 to 13.6 .. 26 to 30 ...... 1. reinfection occurs, treatment may be 14.1 to 20.0 .. 31 to 44 ...... 1 1/2. repeated. 20.4 to 27.2 .. 45 to 60 ...... 2 ...... 1 27.7 to 40.9 .. 61 to 90 ...... 1 1/2 (ii) Indications for use. For removal of 41.3 to 54.5 .. 91 to 120 ...... 2 tapeworms (Dipylidium caninum and Taenia taeniaeformis), hookworms (ii) Indications for use. For the re- (Ancylostoma tubaeforme), and large moval of tapeworms (Dipylidium roundworms (Toxocara cati) in cats and caninum, Taenia pisiformis, Echinococcus kittens. granulosus); hookworms (Ancylostoma (iii) Limitations. Not for use in kit- caninum, Uncinaria stenocephala); tens less than 2 months of age or ascarids (Toxocara canis, Toxascaris weighing less than 2.0 pounds. Consult leonina); and whipworms (Trichuris your veterinarian before giving to sick vulpis) and for the removal and control or pregnant animals. of tapeworm Echinococcus multilocularis (2) Dogs—(i) Amount. Administer a in dogs. minimum dose of 5 mg praziquantel (iii) Limitations. Do not use in preg- and 5 mg pyrantel pamoate per kilo- nant animals. Do not use in dogs gram body weight (2.27 mg praziquantel weighing less than 0.9 kilogram (2 and 2.27 mg pyrantel pamoate per pounds) or puppies less than 3 weeks of pound body weight) according to the age. Federal law restricts this drug to dosing tables on labeling. use by or on the order of a licensed vet- (ii) Indications for use. For the treat- erinarian. ment and control of roundworms [59 FR 33908, July 1, 1994, as amended at 61 (Toxocara canis and Toxascaris leonina), FR 29651, June 12, 1996; 68 FR 22293, Apr. 28, hookworms (Ancylostoma caninum, 2003; 71 FR 6677, Feb. 9, 2006] Ancylostoma braziliense, and Uncinaria stenocephala), and tapeworms § 520.1880 Prednisolone tablets. (Dipylidium caninum and Taenia (a) Specifications. Each tablet con- pisiformis) in dogs and puppies. tains 5 or 20 milligrams prednisolone. [58 FR 58652, Nov. 3, 1993, as amended at 72 (b) Sponsor. See No. 061690 in FR 16270, Apr. 4, 2007; 75 FR 54018, Sept. 3, § 510.600(c)(2) of this chapter. 2010] (c) Special considerations. (1) Clinical and experimental data have dem- § 520.1872 Praziquantel, pyrantel onstrated that corticosteroids adminis- pamoate, and febantel tablets. tered orally or parenterally to animals (a) Specifications. Each tablet or may induce the first stage of parturi- chewable tablet contains either: tion when administered during the last (1) Tablet No. 1: 22.7 milligrams trimester of pregnancy and may pre- praziquantel, 22.7 milligrams pyrantel cipitate parturition followed by base, and 113.4 milligrams febantel; or dystocia, fetal death, retained pla- (2) Tablet No. 2: 68 milligrams centa, and metritis. praziquantel, 68 milligrams pyrantel (2) Do not use in viral infections. base, and 340.2 milligrams febantel. Systemic therapy with prednisolone is (3) Tablet No. 3: 136 milligrams (mg) contraindicated in animals with peptic praziquantel, 136 mg pyrantel base, and ulcer, corneal ulcer, and Cushingoid 680.4 mg febantel. syndrome. The presence of diabetes, (b) Sponsor. See 000859 in § 510.600(c) of osteoporosis, predisposition to this chapter. thrombophlebitis, hypertension, con- (c) Conditions of use—(1) Dogs—(i) gestive heart failure, renal insuffi- Amount. Administer as a single dose di- ciency, and active tuberculosis neces- rectly by mouth or in a small amount sitates carefully controlled use. Some of food as follows: of the above conditions occur only

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rarely in dogs but should be kept in stricts this drug to use by or on the mind. order of a licensed veterinarian. (3) Anti-inflammatory action of [42 FR 61594, Dec. 6, 1977, as amended at 43 corticosteroids may mask signs of in- FR 55386, Nov. 28, 1978; 46 FR 8467, Jan. 27, fection. 1981; 46 FR 57477, Nov. 24, 1981; 53 FR 40727, (d) Conditions of use—(1) Amount. Oct. 18, 1988; 56 FR 37473, Aug. 7, 1991; 62 FR Dogs: 2.5 milligrams per 4.5 kilograms 35076, June 30, 1997; 78 FR 21060, Apr. 9, 2013] (10 pounds) body weight per day. Ad- § 520.1920 Prochlorperazine, minister total daily dose orally in isopropamide sustained release equally divided doses 6 to 10 hours capsules. apart until response is noted or 7 days (a) Specifications. Prochlorperazine, have elapsed. When response is at- isopropamide sustained release cap- tained, dosage should be gradually re- sules contain either: duced until maintenance level is (1) 3.33 milligrams of achieved. prochlorperazine (as the dimaleate) (2) Indications for use. For use in dogs and 1.67 milligrams of isopropamide (as as an anti-inflammatory agent. the iodide), or (3) Limitations. Federal law restricts (2) 10 milligrams of prochlorperazine this drug to use by or on the order of a (as the dimaleate) and 5 milligrams of licensed veterinarian. isopropamide (as the iodide). [57 FR 4718, Feb. 7, 1992, as amended at 60 FR (b) Sponsor. See No. 000069 in 57832, Nov. 22, 1995; 63 FR 148, Jan. 5, 1998] § 510.600(c) of this chapter. (c) Conditions of use. (1) The drug is § 520.1900 Primidone tablets. used for the treatment of dogs in which (a) Specifications. Each tablet con- gastrointestinal disturbances are asso- tains 50 or 250 milligrams of primidone. ciated with emotional stress. (b) Sponsor. See No. 054628 in (2)(i) Capsules described in paragraph (a)(1) of this section are administered § 510.600(c) of this chapter for use of 250 orally to dogs weighing from 4 to 15 milligram tablets; see No. 000856 in pounds at the rate of 1 capsule twice § 510.600(c) of this chapter for use of 50 daily. These capsules are administered and 250 milligram tablets. orally to dogs weighing from 16 to 30 (c) Conditions of use in dogs—(1) pounds at the rate of 1 or 2 capsules Amount. Twenty-five milligrams of twice daily. For dogs weighing less primidone per pound of body weight (55 than 4 pounds, administer orally an ap- milligrams per kilogram of body propriate fraction of the contents of weight) daily. one of these capsules. (2) Indications for use. For the control (ii) Capsules described in paragraph of convulsions associated with idio- (a)(2) of this section are given to dogs pathic epilepsy, epileptiform convul- weighing 30 pounds and over at the rate sions, viral encephalitis, distemper, of 1 capsule twice daily. and hardpad disease that occurs as a (3) For use only by or on the order of clinically recognizable lesion in certain a licensed veterinarian. entities in dogs. [40 FR 13838, Mar. 27, 1975, as amended at 56 (3) Limitations. The tablets may be FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, administered whole or crushed and 1995] mixed with the food. When convulsions are frequent, the dosage should be di- § 520.1921 Prochlorperazine, vided and administered at intervals. isopropamide, with neomycin sus- Reduction in dosage should be made tained-release capsules. gradually and never be abruptly dis- (a) Specifications. Each capsule con- continued. Do not use in feline species, tains either: as primidone appears to have a specific (1) Capsule No. 1: 3.33 milligrams of neurotoxicity in cats. Federal law re- prochlorperazine (as the dimaleate), 1.67 milligrams of isopropamide (as the iodide), and 25 milligrams of neomycin base (as the sulfate); or

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(2) Capsule No. 3: 10 milligrams of (iii) Federal law restricts this drug to prochlorperazine (as the dimaleate), 5 use by or on the order of a licensed vet- milligrams of isopropamide (as the io- erinarian. dide), and 75 milligrams of neomycin (b) [Reserved] base (as the sulfate). [40 FR 13838, Mar. 27, 1975, as amended at 43 (b) Sponsor. See No. 000069 in FR 55386, Nov. 28, 1978; 59 FR 5705, Feb. 8, § 510.600(c) of this chapter. 1994] (c) Conditions of use—(1) Amount. Ad- minister capsules orally twice daily to § 520.2002 Propiopromazine hydro- dogs as follows: chloride. (a) Chemical name. 1-Propanone, 1-[10- Number of cap- [3-(dimethylamino) propyl] sules per dose Animal weight (pounds) phenothiazine-2-yl]-, Capsule Capsule monohydrochloride. No. 1 No. 3 (b) Specifications. The drug is admin- 10 to 20 ...... 1 istered in a chewable tablet containing 20 to 30 ...... 2 10 to 20 milligrams of propiopromazine Over 30 ...... 3 1 hydrochloride. Over 60 ...... 2 (c) Sponsor. See No. 000856 in § 510.600(c) of this chapter. (2) Indications for use. For treatment (d) Conditions of use. (1) The drug is of dogs in which infectious bacterial intended for oral administration to gastroenteritis is associated with emo- dogs as a tranquilizer. It is used as an tional stress. aid in handling difficult, excited, and (3) Limitations. Do not continue medi- unruly dogs, and in controlling exces- cation longer than 5 days. Overdosage sive kennel barking, car sickness, and or prolonged administration may severe dermatitis. It is also indicated produce nephrotoxicity as manifested for use in minor surgery and prior to by albuminuria, presence of granular routine examinations, laboratory pro- casts and depressed urinary output. If cedures, and diagnostic procedures. it is desirable to administer a vasocon- (2) It is administered at the rate of strictor, norepinephrine is the drug of 0.5 to 2 milligrams of propiopromazine choice. Federal law restricts this drug hydrochloride per pound of body weight to use by or on the order of a licensed once or twice daily depending upon the veterinarian. degree of tranquilization desired. [49 FR 14103, Apr. 10, 1984, as amended at 56 NOTE: Not for use with organophosphates FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, and/or procaine hydrochloride, as 1995] phenothiazine may potentiate the toxicity of organophosphates and the activity of pro- § 520.1962 Promazine hydrochloride. caine hydrochloride. Overdosage may produce significant depression. (a)(1) Chemical name. 10-[3- (3) For use only by or on the order of (Dimethylamino)propyl]phenothiazine a licensed veterinarian. monohydrochloride. (2) Specifications. Conforms to N.F. [40 FR 13838, Mar. 27, 1975, as amended at 46 XII. FR 60570, Dec. 11, 1981; 61 FR 5506, Feb. 13, 1996] (3) Sponsor. See No. 000856 in § 510.600(c) of this chapter. § 520.2041 Pyrantel pamoate chewable (4) [Reserved] tablets. (5) Conditions of use. (i) The drug is (a) Specifications. Each tablet con- used for quieting excitable, unruly, or tains pyrantel pamoate equivalent to intractable horses. It is administered 22.7 or 113.5 milligrams pyrantel base. at a dosage level of 0.45 to 0.9 milli- (b) Sponsor. See Nos. 017135 and 051311 grams of promazine hydrochloride per in § 510.600(c) of this chapter. pound of body weight mixed with an (c) Conditions of use—(1) Amount. Pro- amount of feed that will be readily con- vides at least 2.27 milligrams pyrantel sumed. base per pound body weight for dogs (ii) Do not use in horses intended for weighing more than 5 pounds, and at food. least 4.54 milligrams of pyrantel base

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per pound body weight for dogs weigh- fecal examination should be conducted ing 5 pounds or less. 2 to 4 weeks after first treatment regi- (2) Indications for use—(i) In dogs and men to determine the need for re-treat- puppies. For removal of ascarids ment. Consult your veterinarian for as- (Toxocara canis; Toxascaris leonina) and sistance in the diagnosis, treatment, hookworms (Ancylostoma caninum; and control of parasitism. Uncinaria stenocephala). [43 FR 52700, Nov. 14, 1978, as amended at 49 (ii) In puppies and adult dogs and in FR 22073, May 25, 1984; 57 FR 48163, Oct. 22, lactating bitches after whelping. To 1992; 58 FR 44611, Aug. 24, 1993] prevent reinfection of Toxocara canis. (3) Limitations. Administer to puppies § 520.2043 Pyrantel pamoate suspen- at 2, 3, 4, 6, 8, and 10 weeks of age. Ad- sion. minister to lactating bitches 2 to 3 (a) Specifications. (1) Each milliliter weeks after whelping. Retreatment of (mL) contains pyrantel pamoate equiv- adult dogs may be necessary at month- alent to 50 milligrams (mg) pyrantel ly intervals as determined by labora- base. tory fecal examinations. Consult your (2) Each mL contains pyrantel veterinarian for assistance in the diag- pamoate equivalent to 2.27 or 4.54 mg nosis, treatment, and control of para- pyrantel base. sitism. (3) Each mL contains pyrantel [52 FR 37937, Oct. 13, 1987, as amended at 57 pamoate equivalent to 4.54 mg pyrantel FR 48163, Oct. 22, 1992; 58 FR 44611, Aug. 24, base. 1993; 66 FR 9650, Feb. 9, 2001; 67 FR 21996, May (b) Sponsors. See sponsors in 2, 2002] § 510.600(c) of this chapter for uses as in paragraph (d) of this section. § 520.2042 Pyrantel pamoate tablets. (1) Nos. 000069, 000859, and 058829 for (a) Specifications. Each tablet con- use of the product described in para- tains pyrantel pamoate equivalent to graph (a)(1) as in paragraph (d)(1) of 22.7, 45.4, or 113.5 milligrams of this section. pyrantel base. (2) Nos. 000069, 055246, 058829, and (b) Sponsor. See No. 017135 in 059130 for use of the products described § 510.600(c) of this chapter. in paragraph (a)(2) as in paragraph (c) Conditions of use. It is used for (d)(2) of this section. dogs as follows: (3) No. 023851 for use of the product (1) Amount. For dogs weighing over 5 described in paragraph (a)(3) as in para- pounds, use at least 2.27 milligrams of graph (d)(2) of this section. pyrantel base per pound of body (c) Special considerations. See § 500.25 weight; for dogs weighing 5 pounds or of this chapter. less, use at least 4.54 milligrams of (d) Conditions of use—(1) Horses and pyrantel base per pound of body ponies. It is used as follows: weight. (i) Amount. 3 mg per pound (/lb) body (2) Indications for use. For removal weight as a single dose mixed with the and control of large roundworms usual grain ration, or by stomach tube (ascarids) (Toxocara canis and or dose syringe. Toxascaris leonina), and hookworms (ii) Indications for use. For the re- (Ancylostoma caninum and Uncinaria moval and control of mature infections stenocephala). of large strongyles (Strongylus vulgaris, (3) Limitations. Administer orally di- S. edentatus, S. equinus); pinworms rectly or in a small amount of food. To (Oxyuris equi); large roundworms prevent reinfection of T. canis in pup- (Parascaris equorum); and small pies, lactating bitches after whelping, strongyles. and adult dogs; treat puppies 2, 3, 4, 6, (iii) Limitations. Do not use in horses 8, and 10 weeks of age; treat lactating intended for human consumption. bitches 2 to 3 weeks after whelping; When the drug is for administration by routinely treat adult dogs monthly. Do stomach tube, it shall be labeled: not withhold food prior to or after ‘‘Federal law restricts this drug to use treatment. The presence of these by or on the order of a licensed veteri- parasites should be confirmed by lab- narian.’’ oratory fecal examination. A followup (2) Dogs. It is used as follows:

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(i) Dogs and puppies—(A) Amount. 2.27 parasites: large strongyles (Strongylus mg/lb body weight as a single dose in vulgaris, S. edentatus, S. equinus); small the animal’s feed bowl by itself or strongyles; pinworms (Oxyuris equi); mixed in a small quantity of food. and large roundworms (Parascaris (B) Indications for use. For the re- equorum). moval of large roundworms (Toxocara (ii) 6 mg/lb body weight as single oral canis and Toxascaris leonina) and dose for the removal and control of ma- hookworms (Ancylostoma caninum and ture infections of tapeworms Uncinaria stenocephala). (Anoplocephala perfoliata). (C) Limitations. Additional treatment (2) Limitations. Do not use in horses may be required and should be con- intended for human consumption. firmed by fecal examination within 2 [70 FR 29447, May 23, 2005, as amended at 76 to 4 weeks. FR 17337, Mar. 29, 2011; 78 FR 17596, Mar. 22, (ii) Dogs, puppies, and lactating bitches 2013] after whelping—(A) Amount. 2.27 mg/lb body weight. § 520.2045 Pyrantel tartrate powder; (B) Indications for use. To prevent re- pyrantel tartrate pellets. infections of T. canis. (a) Specifications. (1) Pyrantel tar- (C) Limitations. Administer to puppies trate powder horse wormer contains at 2, 3, 4, 6, 8, and 10 weeks of age. Ad- 11.3 percent and swine wormer 10.6 per- minister to lactating bitches 2 to 3 cent pyrantel tartrate. weeks after whelping. Adult dogs kept (2) Pyrantel tartrate pellets colt and in heavily contaminated quarters may horse wormer contains 1.25 percent be treated at monthly intervals. pyrantel tartrate. [67 FR 43248, June 27, 2002, as amended at 68 (b) Sponsor. (1) See No. 000069 in FR 54803, Sept. 19, 2003; 68 FR 55199, Sept. 23, § 510.600(c) of this chapter for condi- 2003; 68 FR 55825, Sept. 29, 2003; 75 FR 52622, tions of use provided for in paragraphs Aug. 27, 2010; 76 FR 17337, Mar. 29, 2011; 78 FR (d) (1) and (2) of this section. 17596, Mar. 22, 2013] (2) See No. 061623 in § 510.600(c) of this chapter, for conditions of use provided § 520.2044 Pyrantel pamoate paste. for in paragraph (d)(3) of this section. (a) Specifications—(1) Each milliliter (c) Related tolerances. See § 556.560 of (mL) contains 180 milligrams (mg) this chapter. pyrantel base (as pyrantel pamoate). (d) Conditions of use. It is used in: (1) (2) Each mL contains 226 mg pyrantel Horses and ponies: base (as pyrantel pamoate). (i) For the removal and control of in- (3) Each mL contains 171 mg pyrantel fections from the following mature base (as pyrantel pamoate). parasites: Large strongyles (Strongylus (b) Sponsors. See sponsors in vulgaris, Strongylus edentatus, § 510.600(c) of this chapter. Strongylus equinus), small strongyles (1) No. 000069 for use of product de- (Trichonema spp., Triodontophorus), scribed in paragraph (a)(1) of this sec- pinworms (Oxyuris), and large tion as in paragraph (d)(1)(i) and (d)(2) roundworms (Parascaris). of this section. (ii) It is administered as a single dose (2) No. 000859 for use of product de- at 0.57 gram of pyrantel tartrate per 100 scribed in paragraph (a)(2) of this sec- pounds of body weight mixed with the tion as in paragraph (d) of this section. usual grain ration. (3) No. 061623 for use of product de- (iii) It is recommended that severely scribed in paragraph (a)(3) of this sec- debilitated animals not be treated with tion as in paragraph (d)(1)(i) and (d)(2) this drug. Do not administer by stom- of this section. ach tube or dose syringe. The drug (c) Special considerations. See § 500.25 should be used immediately after the of this chapter. package is opened. (d) Conditions of use. It is used in (iv) Warning: Not for use in horses horses and ponies as follows: and ponies to be slaughtered for food (1) Amounts and indications for use—(i) purposes. 3 mg per pound (/lb) body weight as sin- (2) Swine: gle oral dose for removal and control of (i) For the removal and control of infections from the following mature large roundworms (Ascaris suum) and

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nodular worm (Oesophagostomum) infec- (3) Limitations. Federal law restricts tions. this drug to use by or on the order of a (ii) It is added to feed at 0.4 gram licensed veterinarian. pyrantel tartrate per pound of [76 FR 18648, Apr. 5, 2011, as amended at 79 nonpelleted ration. The ration is ad- FR 10964, Feb. 27, 2014] ministered as a single treatment as the sole ration at the rate of 1 pound per 40 § 520.2098 Selegiline hydrochloride pounds of animal weight for animals up tablets. to 200 pounds. Animals 200 pounds and (a) Specifications. Each tablet con- over are administered 5 pounds of ra- tains either 2, 5, 10, 15, or 30 milligrams tion per animal. of selegiline hydrochloride. (iii) Fast pigs over night for optimum (b) Sponsor. See No. 000069 in results. Water should be made avail- § 510.600(c) of this chapter. able to animals during fasting and (c) [Reserved] treatment periods. Consult veteri- (d) Conditions of use—Dogs—(1) Dos- narian before using in severely debili- age. 1 milligram per kilogram (0.45 mil- tated animals. The drug should be used ligram per pound) of body weight. immediately after the package is (i) Indications for use. For control of opened. clinical signs associated with uncom- (iv) Warning: Do not treat within 24 plicated pituitary-dependent hours of slaughter. hyperadrenocorticism in dogs. (3) Horses and colts: (ii) Limitations. Administer orally (i) For the removal and control of in- once daily. If no improvement in clin- fections from the following mature ical signs or physical examination find- parasites: Large strongyles (Strongylus ings after 2 months of therapy, in- vulgaris, Strongylus edentatus, crease dose to a maximum of 2 milli- Strongylus equinus), small strongyles grams per kilogram once daily. Federal (Trichonema spp., Triodontophorus), law restricts this drug to use by or on pinworms (Oxyuris), and large the order of a licensed veterinarian. roundworms (Parascaris). (2) Dosage. 0.5 to 1.0 milligram per (ii) It is administered as a single dose kilogram of body weight once daily. at 12.5 milligrams of pyrantel tartrate (i) Indications for use. For the control per 2.2 pounds of body weight mixed of clinical signs associated with canine with the usual grain ration. cognitive dysfunction syndrome. (iii) It is recommended that severely (ii) Limitations. Federal law restricts debilitated animals not be treated with this drug to use by or on the order of a this drug. licensed veterinarian. (iv) Warning: Do not use in horses or colts intended for food. [62 FR 34632, June 27, 1997; 62 FR 55159, Oct. 23, 1997, as amended at 63 FR 29551, June 1, [40 FR 13838, Mar. 27, 1975, as amended at 59 1998; 64 FR 2122, Jan. 13, 1999] FR 28769, June 3, 1994; 69 FR 41427, July 9, 2004; 76 FR 40229, July 8, 2011] § 520.2100 Selenium, vitamin E capsules. § 520.2075 Robenacoxib. (a) Specifications. The capsules con- (a) Specifications. Each tablet contain 2.19 milligrams of sodium selenite tains 6 milligrams (mg) robenacoxib. (equivalent to 1 milligram of selenium) (b) Sponsors. See No. 058198 in and 56.2 milligrams of vitamin E (68 § 510.600(c) of this chapter. I.U.) (as d-alpha tocopheryl acid succi- (c) Conditions of use in cats—(1) nate) or 0.548 milligram of sodium sele- Amount. Administer 0.45 mg per pound nite (equivalent to .25 milligram of se- (/lb) (1 mg/kilogram (kg)) once daily. lenium and 14 milligrams of vitamin E (2) Indications for use. For the control (17 I.U.) (as d-alpha tocopheryl acid of postoperative pain and inflamma- succinate.) tion associated with orthopedic sur- (b) Sponsor. See No. 000061 in gery, ovariohysterectomy, and castra- § 510.600(c) of this chapter. tion in cats weighing at least 5.5 lb (2.5 (c) Conditions of use. (1) The drug is kg) and at least 4 months of age; for up intended for use as an aid in alleviating to a maximum of 3 days. and controlling inflammation, pain,

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and lameness associated with certain (3) Limitations. Federal law restricts arthropathies in dogs. this drug to use by or on the order of a (2) The capsules are administered licensed veterinarian. orally with the larger capsules admin- [73 FR 6607, Feb. 5, 2008] istered at a dosage level of 1 capsule per 20 pounds of body weight to a max- § 520.2123b Spectinomycin powder. imum of 5 capsules with the dosage re- (a) Specifications. Each gram (g) of peated at 3 day intervals until a satis- powder contains spectinomycin factory therapeutic response is ob- dihydrochloride pentahydrate equiva- served. A maintenance dosage is then lent to 0.5 g spectinomycin. administered consisting of 1 capsule (b) Sponsor. See No. 061623 in per 40 pounds of body weight, with a § 510.600(c) of this chapter. minimum of 1 capsule per 40 pounds of (c) Related tolerances. See § 556.600 of body weight, with a minimum of 1 cap- this chapter. sule, given every 3 days, or 7 days, or (d) Conditions of use in chickens. It is longer, as required to maintain im- administered in the drinking water of provement or an asymptomatic condi- growing chickens as follows: tion. For dogs under 20 pounds of body (1) Indications for use and amounts—(i) weight, the small capsules are adminis- For increased rate of weight gain and tered orally at a dosage level of 1 per 5 improved feed efficiency in broiler chickens, administer 0.5 g per gallon of pounds of body weight with a minimum water as the only source of drinking of 1 capsule which dosage is repeated at water for the first 3 days of life and for 3 day intervals until a satisfactory re- 1 day following each vaccination. sponse is observed then a maintenance (ii) As an aid in controlling infec- regimen is initiated with 1 capsule per tious synovitis due to Mycoplasma 10 pounds of body weight, minimum of synoviae in broiler chickens, admin- 1 capsule, every 3 days, or 7 days, or ister 1 g per gallon of water as the only longer as required to maintain contin- source of drinking water for the first 3 ued improvement or an asymptomatic to 5 days of life. condition. (iii) As an aid in the prevention or (3) Federal law restricts this drug to control of losses due to CRD associated use by or on the order of a licensed vet- with M. gallisepticum (PPLO) in grow- erinarian. ing chickens, administer 2 g per gallon of water as the only source of drinking [40 FR 13838, Mar. 27, 1975, as amended at 52 water for the first 3 days of life and for FR 7832, Mar. 13, 1987; 52 FR 9756, Mar. 26, 1 day following each vaccination. 1987] (2) Limitations. Do not administer to § 520.2123 Spectinomycin oral dosage laying chickens. Do not administer forms. within 5 days of slaughter. [73 FR 6607, Feb. 5, 2008] § 520.2123a Spectinomycin tablets. (a) Specifications. Each tablet con- § 520.2123c Spectinomycin solution. tains spectinomycin dihydrochloride (a) Specifications. Each milliliter of pentahydrate equivalent to 100 milli- solution contains spectinomycin grams (mg) spectinomycin. dihydrochloride pentahydrate equiva- (b) Sponsor. See No. 061623 in lent to 50 milligrams (mg) § 510.600(c) of this chapter. spectinomycin. (c) Conditions of use in dogs—(1) (b) Sponsors. See Nos. 000856, 000859, Amount. Administer orally to provide and 061623 in § 510.600(c) of this chapter. 10 mg per pound (lb) of body weight (c) Related tolerances. See § 556.600 of this chapter. twice daily. Dosage may be continued (d) Conditions of use in swine—(1) for 4 consecutive days. Amount. Administer 5 mg per pound (lb) (2) Indications for use. For the treat- of body weight orally twice daily for 3 ment of infectious diarrhea and to 5 days. gastroenteritis caused by organisms (2) Indications for use. For the treat- susceptible to spectinomycin. ment and control of porcine enteric

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colibacillosis (scours) caused by E. coli spinosad and 0.2 mg/lb (0.5 mg/kg) of susceptible to spectinomycin in pigs body weight milbemycin oxime. under 4 weeks of age. (2) Indications for use. To kill fleas; (3) Limitations. Do not administer to for the prevention and treatment of pigs over 15 lb body weight or over 4 flea infestations (Ctenocephalides felis); weeks of age. Do not administer within for the prevention of heartworm dis- 21 days of slaughter. ease (Dirofilaria immitis); and for the treatment and control of adult [73 FR 6607, Feb. 5, 2008] hookworm (Ancylostoma caninum), adult roundworm (Toxocara canis and § 520.2130 Spinosad. Toxascaris leonina), and adult (a) Specifications. Each chewable tab- whipworm (Trichuris vulpis) infections let contains 90, 140, 270, 560, 810, or 1620 in dogs and puppies 8 weeks of age or milligrams (mg) spinosad. older and 5 lbs of body weight or great- (b) Sponsor. See No. 000986 in § 510.600 er. of this chapter. (3) Limitations. Federal law restricts (c) Special considerations. 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. [76 FR 12563, Mar. 8, 2011] (d) Conditions of use—(1) Dogs—(i) Amount. Administer tablets once a § 520.2150 Stanozolol oral dosage month at a recommended minimum forms. dosage of 13.5 mg per pound (30 mg per kilogram) of body weight. § 520.2150a Stanozolol tablets. (ii) Indications for use. To kill fleas (a) Specifications. Each tablet con- and for the prevention and treatment tains 2 milligrams of stanozolol. of flea infestations (Ctenocephalides (b) Sponsor. No. 000009 in § 510.600(c) of felis) for 1 month on dogs and puppies this chapter. 14 weeks of age and older and 3.3 (c) Conditions of use. (1) Used as an pounds of body weight or greater. anabolic steroid treatment in dogs and (2) Cats—(i) Amount. Administer tab- cats. lets once a month at a minimum dos- (2) Administered orally to cats and age of 22.5 mg per pound (50 mg per small breeds of dogs, 1⁄2 to 1 tablet kilogram) of body weight. twice daily for several weeks; to large (ii) Indications for use. To kill fleas breeds of dogs, 1 to 2 tablets twice and for the prevention and treatment daily for several weeks. The tablets of flea infestations (C. felis) for 1 month may be crushed and administered in on cats and kittens 14 weeks of age and feed. older and 2 pounds of body weight or (3) Federal law restricts this drug to greater. use by or on the order of a licensed veterinarian. [77 FR 60623, Oct. 4, 2012] [40 FR 46101, Oct. 6, 1975, as amended at 42 FR § 520.2134 Spinosad and milbemycin. 36995, July 19, 1977. Redesignated at 50 FR 38114, Sept. 20, 1985, and amended at 55 FR (a) Specifications. Each chewable tab- 23076, June 6, 1990] let contains 140 milligrams (mg) spinosad and 2.3 mg milbemycin oxime, § 520.2150b Stanozolol chewable tab- 270 mg spinosad and 4.5 mg milbemycin lets. oxime, 560 mg spinosad and 9.3 mg (a) Specifications. Each chewable tab- milbemycin oxime, 810 mg spinosad let contains 2 milligrams of stanozolol. and 13.5 mg milbemycin oxime, or 1,620 (b) Sponsor. No. 000009 in § 510.600(c) of mg spinosad and 27 mg milbemycin this chapter. oxime. (c) Conditions of use. (1) Used as an (b) Sponsor. See No. 000986 in § 510.600 anabolic steroid treatment in dogs. of this chapter. (2) Administered orally to small (c) Conditions of use in dogs—(1) breeds of dogs, 1⁄2 to 1 tablet twice daily Amount. Administer once a month at a for several weeks; to large breeds of minimum dosage of 13.5 mg/pound (lb) dogs, 1 to 2 tablets twice daily for sev- (30 mg/kilogram (kg)) of body weight eral weeks.

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(3) Federal law restricts this drug to § 520.2158b Dihydrostreptomycin tab- use by or on the order of a licensed vet- lets. erinarian. (a) Specifications. Each tablet con- [50 FR 38114, Sept. 20, 1985, as amended at 55 tains 37.5 milligrams dihydrostrepto- FR 23076, June 6, 1990] mycin (as the sulfate) with 375 milligrams chlorhexidine dihydrochloride. § 520.2158 Streptomycin/dihydro- (b) Sponsor. See No. 000856 in streptomycin oral dosage forms. § 510.600(c) of this chapter. (c) Related tolerances. See §§ 556.120 § 520.2158a Streptomycin sulfate oral and 556.200 of this chapter. solution. (d) Conditions of use. Calves—(1) (a) Specifications. Solution containing Amount. 150 milligrams of dihydro- 25 percent streptomycin sulfate. streptomycin and 1.5 grams of (b) Sponsor. See Nos. 033008 and 055462 chlorhexidine dihydrochloride per 100 in § 510.600(c) of this chapter. pounds of body weight per day. (c) Related tolerances. See § 556.610 of (2) Indications for use. Treatment of this chapter. bacterial scours in calves. (d) Conditions of use. Use in drinking (3) Limitations. Administer orally water as follows: once a day for 5 days; withdraw 3 days (1) Calves and swine—(i) Amount. 10 to before slaughter. 15 milligrams per pound (mg/pound) of [57 FR 37327, Aug. 18, 1992; 57 FR 42623, Sept. body weight (1.0 to 1.5 grams per gal- 15, 1992] lon). (ii) Indications for use. Treatment of § 520.2158c Dihydrostreptomycin oral suspension. bacterial enteritis caused by Esch- erichia coli and Salmonella spp. suscep- (a) Specifications. Each milliliter con- tible to streptomycin. tains 1.25 milligrams dihydrostrepto- (iii) Limitations. Calves: Do not ad- mycin (as the sulfate) with 12.5 milli- minister for more than 5 days. Swine: grams chlorhexidine dihydrochloride. Do not administer for more than 4 (b) Sponsor. See No. 000856 in days. Prepare fresh solution daily. § 510.600(c) of this chapter. Calves: Withdraw 2 days before slaugh- (c) Related tolerances. See §§ 556.120 ter. As sole source of streptomycin. and 556.200 of this chapter. Warning: Certain strains of bacteria (d) Conditions of use. Calves—(1) may develop a tolerance for strepto- Amount. 150 milligrams of dihydro- mycin. Consult a veterinarian or ani- streptomycin and 1.5 grams of mal pathologist for diagnosis. chlorhexidine dihydrochloride per 100 (2) Chickens—(i) Amount. 10 to 15 mg/ pounds of body weight per day. pound of body weight (0.6 to 0.9 grams (2) Indications for use. Treatment of per gallon). bacterial scours in calves. (3) Limitations. Administer orally (ii) Indications for use. Treatment of once a day for 5 days; withdraw 3 days nonspecific infectious enteritis caused before slaughter. by organisms susceptible to streptomycin. [57 FR 37327, Aug. 18, 1992] (iii) Limitations. Chickens: Do not administer for more than 5 days. With- § 520.2160 Styrylpyridinium, diethylcarbamazine oral dosage draw 4 days before slaughter. Do not forms. administer to chickens producing eggs for human consumption. Prepare fresh § 520.2170 Sulfabromomethazine so- solution daily. As sole source of strep- dium boluses. tomycin. Warning: Certain strains of (a) Specifications. Each bolus contains bacteria may develop a tolerance for 15 grams of sulfabromomethazine so- streptomycin. Consult a veterinarian dium. or animal pathologist for diagnosis. (b) Related tolerance. See § 556.620 of [57 FR 37327, Aug. 18, 1992, as amended at 58 this chapter. FR 47211, Sept. 8, 1993; 63 FR 51821, Sept. 29, (c) Sponsor. See No. 050604 in 1998] § 510.600(c) of this chapter.

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(d) NAS/NRC status. These conditions § 520.2200 Sulfachlorpyridazine. of use are NAS/NRC reviewed and found effective. NADA’s for these uses need (a) Specifications.—(1) Sodium not include effectiveness data as speci- sulfachlorpyridazine powder. fied by § 514.111 of this chapter, but (2) Each bolus contains 2 grams may require bioequivalency and safety sulfachlorpyridazine. information. (3) Each tablet contains 250 milli- (e) Conditions of use. Cattle—(1) grams (mg) sulfachlorpyridazine. Amount. 90 milligrams per pound body (b) Sponsor. See No. 000010 in weight. § 510.600(c) of this chapter. (2) Indications for use. Treatment of (c) Related tolerances. See § 556.630 of necrotic pododermatitis (foot rot) and this chapter. calf diphtheria caused by Fusobacterium (d) Conditions of use. It is used as fol- necrophorum; colibacillosis (scours) lows: caused by Escherichia coli; bacterial (1) Calves—(i) Amount. Administer 30 pneumonia and bovine respiratory dis- to 45 mg sulfachlorpyridazine powder ease complex (shipping fever complex) per pound (/lb) of body weight per day associated with Pasteurella spp.; acute metritis and acute mastitis caused by in milk or milk replacer, or in a bolus, Streptococcus spp. in divided doses twice daily for 1 to 5 (3) Limitations. Administer orally; re- days. peat in 48 hours if necessary; milk (ii) Indications for use. For the treat- taken from animals within 96 hours (8 ment of diarrhea caused or complicated milkings) of latest treatment must not by Escherichia coli (colibacillosis). be used for food; do not administer (iii) Limitations. Treated ruminating within 18 days of slaughter; dis- calves must not be slaughtered for food continue use if hematuria, crystalluria during treatment or for 7 days after or severe depression are noticed; if the last treatment. A withdrawal pe- signs persist after 2 or 3 days consult a riod has not been established for this veterinarian. 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] veal. (2) Swine—(i) Amount. Administer 20 § 520.2184 Sodium sulfachloropyrazine to 35 mg/lb body weight per day, in di- monohydrate. vided doses twice daily for 1 to 5 days: (a) Chemical name. 2-Sulfamido-6- (A) In drinking water or chloroxyrazine, sodium. (B) For individual treatment, in an (b) Sponsor. See Nos. 053501 in oral suspension containing 50 mg per § 510.600(c) of this chapter. milliliter. (c) Related tolerances. See § 556.625 of (ii) Indications for use. For the treat- this chapter. ment of diarrhea caused or complicated (d) Conditions of use. It is used in the by E. coli (colibacillosis). drinking water of broilers, breeder flocks, and replacement chickens as (iii) Limitations. Treated swine must follows: not be slaughtered for food during (1) Amount. 0.03 percent. treatment or for 4 days after the last (2) Indications for use. Treatment of treatment. coccidiosis. (3) Dogs—(i) Amount. Administer tab- (3) Limitations. Administer in drink- lets orally at 500 mg per 10 to 15 lb of ing water for 3 days as sole source of body weight daily, in two or three di- drinking water and sulfonamide medi- vided doses. cation; withdraw 4 days prior to (ii) Indications for use. As an aid in slaughter; not to be administered to the treatment of infectious chickens producing eggs for human tracheobronchitis and infections consumption. caused by E. coli, and in the treatment [40 FR 13838, Mar. 27, 1975, as amended at 50 of infections caused by other Gram- FR 41489, Oct. 11, 1985; 54 FR 12188, Mar. 24, positive and Gram-negative organisms 1989; 55 FR 8460, Mar. 8, 1990; 64 FR 15684, Apr. that are susceptible to sulfonamide 1, 1999; 67 FR 78355, Dec. 24, 2002] therapy.

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(iii) Limitations. Federal law restricts solution) for 2 to 3 days. If disease re- this drug to use only by or on the order curs, repeat treatment. of a licensed veterinarian. (ii) Limitations. Make fresh solution [75 FR 10166, Mar. 5, 2010] daily. Do not treat chickens within 14 days of slaughter for food. Do not § 520.2215 Sulfadiazine/pyrimethamine medicate chickens producing eggs for suspension. human consumption. (a) Specifications. Each milliliter (2) Turkeys—(i) Amounts and indica- (mL) of suspension contains 250 milli- tions for use—(A) As an aid in the con- grams (mg) sulfadiazine (as the sodium trol of coccidiosis caused by Eimeria salt) and 12.5 mg pyrimethamine. meleagrimitis and E. adenoeides suscep- (b) Sponsor. See No. 055246 in tible to sulfamerazine, sulfamethazine, § 510.600(c) of this chapter. and sulfaquinoxaline: provide medi- (c) Conditions of use in horses—(1) cated water (0.25 percent solution) for 2 Amount. Administer orally 20 mg sulfa- days, then plain water for 3 days, then diazine per kilogram (kg) body weight medicated water (0.25 percent solution) and 1 mg/kg pyrimethamine daily. for 2 days, then plain water for 3 days, (2) Indications for use. For the treat- then medicated water (0.25 percent so- ment of equine protozoal lution) for 2 days. Repeat if necessary. myeloencephalitis (EPM) caused by Do not change litter. Sarcocystis neurona. (B) As an aid in the control of acute (3) Limitations. Do not use in horses fowl cholera caused by Pasteurella intended for human consumption. Fed- multocida susceptible to sulfamerazine, eral law restricts this drug to use by or sulfamethazine, and sulfaquinoxaline: on the order of a licensed veterinarian. provide medicated water (0.4 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, curs, repeat treatment. 2010] (ii) Limitations. Make fresh solution daily. Do not treat turkeys within 14 § 520.2218 Sulfamerazine, days of slaughter for food. Do not sulfamethazine, and medicate turkeys producing eggs for sulfaquinoxaline powder. human consumption. (a) Specifications. Each 195-gram (g) packet of powder contains 78 g sulfa- [71 FR 13001, Mar. 14, 2006] merazine, 78 g sulfamethazine, and 39 g § 520.2220 Sulfadimethoxine oral dos- sulfaquinoxaline. age forms. (b) Sponsor. See No. 046573 in § 510.600(c) of this chapter. § 520.2220a Sulfadimethoxine oral so- (c) Related tolerances. See §§ 556.670 lution and soluble powder. and 556.685 of this chapter. (a) Approvals. (1) For oral solution (d) Conditions of use—(1) Chickens—(i) containing 12.5 percent (3.75 grams per Amounts and indications for use—(A) As ounce) sulfadimethoxine, see Nos. an aid in the control of coccidiosis 000069, 000859, 054628, 054925, and 057561 caused by Eimeria tenella and E. necatrix susceptible to sulfamerazine, in § 510.600(c). sulfamethazine, and sulfaquinoxaline: (2) For soluble powder, each 107 provide medicated water (0.4 percent grams contain the equivalent of 94.6 solution) for 2 to 3 days, then plain grams of sulfadimethoxine (as the so- water for 3 days, then medicated water dium salt); see Nos. 000069, 054925, (0.25 percent solution) for 2 days. If 057561, 058829, 061623, and 066104 in bloody droppings appear, repeat at 0.25 § 510.600(c) of this chapter. percent level for 2 more days. Do not (b) Special considerations. Federal law change litter. prohibits the extralabel use of this (B) As an aid in the control of acute product in lactating dairy cattle. fowl cholera caused by Pasteurella (c) Related tolerances. See § 556.640 of multocida susceptible to sulfamerazine, this chapter. sulfamethazine, and sulfaquinoxaline: (d) Conditions of use. The oral solu- provide medicated water (0.4 percent tion is administered as a cattle drench

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or diluted as directed to prepare drink- preruminating calves. Do not use in ing water. The powder is used to pre- calves to be processed for veal. pare a drench or drinking water. The [40 FR 13838, Mar. 27, 1975, as amended at 58 concentrations and uses of the various FR 6092, Jan. 26, 1993; 59 FR 56000, Nov. 10, solutions are as follows: 1994; 61 FR 4875, Feb. 9, 1996; 62 FR 8371, Feb. (1) Broiler and replacement chickens 25, 1997; 62 FR 23357, Apr. 30, 1997; 62 FR 35076, only—(i) Amount. 1.875 (0.05 percent) June 30, 1997; 62 FR 40932, July 31, 1997; 63 FR grams per gallon. 59714, Nov. 5, 1998; 64 FR 18572, Apr. 15, 1999; (ii) Indications for use. Treatment of 70 FR 73137, Dec. 9, 2005; 71 FR 13542, Mar. 16, disease outbreaks of coccidiosis, fowl 2006; 74 FR 60156, Nov. 20, 2009; 76 FR 17337, Mar. 29, 2011; 77 FR 56770, Sept. 14, 2012; 78 FR cholera, and infectious coryza. 17596, Mar. 22, 2013; 78 FR 21060, Apr. 9, 2013] (iii) Limitations. Administer for 6 consecutive days; do not administer to § 520.2220b Sulfadimethoxine tablets chickens over 16 weeks of age; as sole and boluses. source of drinking water and sul- (a) Sponsors. Approval to firms iden- fonamide medication; as tified in § 510.600(c) of this chapter as sulfadimethoxine solution or follows: sulfadimethoxine soluble sodium salt; (1) To 000069, approval for use as in withdraw 5 days before slaughter. paragraphs (d)(1), (d)(2), and (d)(3) of (2) Meat-producing turkeys only—(i) this section. Amount. 0.938 (0.025 percent) grams per (2) To 000061, approval for use as in gallon. paragraph (d)(2). (ii) Indications for use. Treatment of (b) Related tolerances. See § 556.640 of disease outbreaks of coccidiosis and this chapter. fowl cholera. (c) [Reserved] (iii) Limitations. Administer for 6 con- (d) Conditions of use—(1) Cattle—(i) secutive days; do not administer to Amount. Administer 2.5 grams per 100 turkeys over 24 weeks of age; as sole pounds body weight for 1 day followed source of drinking water and sul- by 1.25 grams per 100 pounds body fonamide medication; as weight per day; treat for 4 to 5 days. sulfadimethoxine solution or (ii) Indications for use. For the treat- sulfadimethoxine soluble sodium salt; ment of shipping fever complex and withdraw 5 days before slaughter. bacterial pneumonia associated with (3) Dairy calves, dairy heifers, and beef Pasteurella spp. sensitive to cattle only—(i) Amount. 1.18 to 2.36 (0.031 sulfadimethoxine; and calf diphtheria to 0.062 percent) grams per gallon. and foot rot associated with (ii) Indications for use. For the treat- Fusobacterium necrophorum sensitive to ment of shipping fever complex and sulfadimethoxine. bacterial pneumonia associated with (iii) Limitations. Do not administer Pasteurella spp. sensitive to within 7 days of slaughter; milk that sulfadimethoxine; and calf diphtheria has been taken from animals during and foot rot associated with treatment and 60 hours (5 milkings) Fusobacterium necrophorum after the latest treatment must not be (Sphaerophorus necrophorus) sensitive used for food. A withdrawal period has to sulfadimethoxine. not been established for this product in (iii) Administer 2.5 grams per 100 preruminating calves. Do not use in pounds of body weight for first day, calves to be processed for veal. then 1.25 grams per 100 pounds of body (2) Dogs and cats—(i) Amount. Admin- weight per day for the next 4 consecu- ister 25 milligrams per pound of body tive days; in drinking water or drench; weight on the first day followed by 12.5 available as a sulfadimethoxine soluble milligrams per pound of body weight powder or a 12.5 percent per day until the animal is free of sulfadimethoxine sodium solution (3.75 symptoms for 48 hours. grams sulfadimethoxine per fluid (ii) Indications for use. Treatment of ounce); if no improvement within 2 to 3 sulfadimethoxine-susceptible bacterial days, reevaluate diagnosis; do not treat infections. beyond 5 days; withdraw 7 days before (iii) Limitations. Federal law restricts slaughter. A withdrawal period has not this drug to use by or on the order of a been established for this product in licensed veterinarian.

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(3) Beef cattle and nonlactating dairy § 520.2220d Sulfadimethoxine- cattle—(i) Amount. Administer one 12.5- ormetoprim tablets. gram-sustained-release bolus for the (a) Specifications. Each tablet con- nearest 200 pounds of body weight, i.e., tains 120 milligrams (100 milligrams of 62.5 milligrams per pound of body sulfadimethoxine and 20 milligrams of weight. Do not repeat treatment for 7 ormetoprim), 240 milligrams (200 milli- days. grams of sulfadimethoxine and 40 milli- (ii) Indications for use. Treatment of grams of ormetoprim), 600 milligrams shipping fever complex and bacterial (500 milligrams of sulfadimethoxine pneumonia associated with organisms and 100 milligrams of ormetoprim), or such as Pasteurella spp. sensitive to 1200 milligrams (1,000 milligrams of sulfadimethoxine; calf diphtheria and sulfadimethoxine and 200 milligrams of foot rot associated with Fusobacterium ormetoprim). necrophorum sensitive to (b) Sponsor. See No. 000069 in sulfadimethoxine. § 510.600(c) of this chapter. (iii) Limitations. Do not use in female (c) Conditions of use—(1) Amount. On dairy cattle 20 months of age or older. the first day of treatment, administer Do not administer within 12 days of 25 milligrams per pound (55 milligrams slaughter. Federal law restricts this per kilogram) of body weight. Then fol- drug to use by or on the order of a li- low with a daily dosage of 12.5 milli- censed veterinarian. grams per pound (27.5 milligrams per kilogram) of body weight. [40 FR 13838, Mar. 27, 1975, as amended at 40 (2) Indications of use. Treatment of FR 43488, Sept. 22, 1975; 49 FR 36830, Sept. 20, 1984; 59 FR 56000, Nov. 10, 1994; 61 FR 4875, skin and soft tissue infections (wounds Feb. 9, 1996; 62 FR 61625, Nov. 19, 1997; 64 FR and abscesses) in dogs caused by 15684, Apr. 1, 1999; 70 FR 16934, Apr. 4, 2005; 76 strains of Staphylococcus aureus and FR 17337, Mar. 29, 2011] Escherichia coli and urinary tract infections caused by Escherichia coli, § 520.2220c Sulfadimethoxine oral sus- Staphlococcus spp., and Proteus mirabilus pension. susceptible to ormetoprim-potentiated (a) Chemical name. N′-(2,6-Dimethoxy- sulfadimethoxine. 4-pyrimidinyl) sulfanilamide. (3) Limitations. Continue treatment (b) Specifications. Each milliliter of until patient is asymptomatic for 48 the drug contains 50 milligrams of hours, but do not exceed a total of 21 sulfadimethoxine. consecutive days. Maintain adequate water intake during the treatment pe- (c) Sponsor. See Nos. 000061 and 000069 riod. Safety in breeding animals has in § 510.600(c) of this chapter. not been established. Federal law re- (1) It is intended for use in the treat- stricts this drug to use by or on the ment of sulfonamide susceptible bac- order of a licensed veterinarian. terial infections in dogs and cats and enteritis associated with coccidiosis in [54 FR 48593, Nov. 24, 1989, as amended at 59 dogs. FR 56000, Nov. 10, 1994; 61 FR 4875, Feb. 9, 1996; 61 FR 46719, Sept. 5, 1996] (2) On the first day of treatment administer an oral dose of 25 milligrams § 520.2240 Sulfaethoxypyridazine. per pound of body weight, then follow with a daily dosage of 12.5 milligrams § 520.2240a Sulfaethoxypyridazine per pound of body weight. Length of drinking water. treatment will depend upon clinical re- (a) Chemical name. N′-(6-Ethoxy-3- sponse. Continue treatment until pa- pyridazinyl) sulfanilamide. tient is asymptomatic for 48 hours. (b) Specifications. Melting point range Maintain adequate water intake during of 180 °C. to 186 °C. the treatment period. (c) Sponsor. See No. 053501 in (3) For use only by or on the order of § 510.600(c) of this chapter. a licensed veterinarian. (d) Related tolerances. See § 556.650 of [40 FR 13838, Mar. 27, 1975, as amended at 59 this chapter. FR 56000, Nov. 10, 1994; 61 FR 4875, Feb. 9, (e) Conditions of use. It is used as fol- 1996; 62 FR 61625, Nov. 19, 1997] lows:

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(1) Swine—(i) Amount. 1.9 to 3.8 grams 72 hours (6 milkings) after the latest per gallon (0.05 percent to 0.1 percent). treatment must not be used for food; (ii) Indications for use. Treatment of for use only by or on the order of a li- bacterial scours pneumonia enteritis, censed veterinarian. bronchitis, septicemia accompanying (2) Amount. 15-gram controlled re- Salmonella cholerasuis infection. lease tablets. (iii) Limitations. Administer 3.8 grams (i) Indications for use. Treatment of per gallon for first day followed by 1.9 foot rot and respiratory infections grams per gallon for not less than 3 (shipping fever and pneumonia) caused days nor more than 9 days as sodium by sulfonamide-susceptible pathogens sulfaethoxypyridazine; do not treat (E. coli, streptococci, staphylococci, within 10 days of slaughter; as sole Sphaerophorus necrophorus and Gram- source of sulfonamide; for use by or on negative rods including Pasteurella); for the order of a licensed veterinarian. use prophylactically in cattle during (2) Cattle—(i) Amount. 2.5 grams per periods of stress for reducing losses due gallon (0.066 percent). to sulfonamide sensitive disease condi- (ii) Indications for use. Treatment of tions. respiratory infections (pneumonia, (ii) Limitations. Administer 100 milli- shipping fever), foot rot, calf scours; as grams per pound of body weight; do not adjunctive therapy in septicemia ac- treat within 16 days of slaughter; as companying mastitis and metritis. sole source of sulfonamide; not for use (iii) Limitations. Administer at the in lactating dairy cows; Federal law re- rate of 1 gallon per 100 pounds of body stricts this drug to use by or on the weight per day for 4 days; as sodium order of a licensed veterinarian. sulfaethoxypyridazine; do not treat within 16 days of slaughter; as sole [40 FR 13838, Mar. 27, 1975, as amended at 67 source of sulfonamide; for use by or on FR 78355, Dec. 24, 2002] the order of a licensed veterinarian; milk that has been taken from animals § 520.2260 Sulfamethazine oral dosage during treatment and for 72 hours (6 forms. milkings) after latest treatment must § 520.2260a Sulfamethazine oblet, tab- not be used for food. let, and bolus. [40 FR 13838, Mar. 27, 1975, as amended at 67 (a)(1) Sponsor. See No. 000010 in FR 78355, Dec. 24, 2002] § 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 cattle, and horses. See No. 061690 in (a) Chemical name. N′-(6-Ethoxy-3- § 510.600(c) of this chapter for use of 5- pyridazinyl) sulfanilamide. , 15-, and 25-gram tablet in beef and (b) Specifications. Melting point range nonlactating dairy cattle. of 180 °C to 186 °C. (c) Sponsor. See No. 053501 in (2) Related tolerance in edible products. § 510.600(c) of this chapter. See § 556.670 of this chapter. (d) Related tolerances. See § 556.650 of (3) Conditions of use—(i) Amount. Ad- this chapter. minister as a single dose 100 milligrams (e) Conditions of use. It is used for cat- of sulfamethazine per pound of body tle as follows: weight the first day and 50 milligrams (1) Amount. 2.5 or 15 grams per tablet. per pound of body weight on each fol- (i) Indications for use. Treatment of lowing day. respiratory infections (pneumonia, (ii) Indications for use. For treatment shipping fever), foot rot, calf scours; as of diseases caused by organisms suscep- adjunctive therapy in septicemia ac- tible to sulfamethazine. companying mastitis and metritis. (A) Beef cattle and nonlactating dairy (ii) Limitations. Administer 25 milli- cattle. Treatment of bacterial pneu- grams per pound of animal weight per monia and bovine respiratory disease day for 4 days; do not treat within 16 complex (shipping fever complex) days of slaughter; as sole source of sul- (Pasteurella spp.), colibacillosis (bac- fonamide; milk that has been taken terial scours) (Escherichia coli), necrotic from animals during treatment and for pododermatitis (foot rot)

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(Fusobacterium necrophorum), calf diph- months of age or older; such use may theria (Fusobacterium necrophorum), cause drug residues in milk. Admin- acute mastitis (Streptococcus spp.), ister with adequate supervision. Fol- acute metritis (Streptococcus spp.), coc- lows recomended dosages carefully. cidiosis (Eimeria bovis and Eimeria Fluid intake must be adequate. If zurnii). symptoms persist after 2 or 3 days, con- (B) Horses. Treatment of bacterial sult a veterinarian. pneumonia (secondary infections asso- [54 FR 15751, Apr. 19, 1989; 54 FR 19283, May 4, ciated with Pasteurella spp.), strangles 1989, as amended at 56 FR 50653, Oct. 8, 1991; (Streptococcus equi), and bacterial en- 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, teritis (Escherichia coli). 1996; 64 FR 66383, Nov. 26, 1999; 67 FR 78355, (iii) Limitations. Administer daily Dec. 24, 2002; 75 FR 10166, Mar. 5, 2010; 76 FR until animal’s temperature and appear- 17337, Mar. 29, 2011] ance are normal. If symptoms persist after using for 2 or 3 days consult a § 520.2260b Sulfamethazine sustained- veterinarian. Fluid intake must be ade- release boluses. quate. Treatment should continue 24 to (a)(1) Sponsor. See No. 000859 in 48 hours beyond the remission of dis- § 510.600(c) of this chapter for use of a ease symptoms, but not to exceed 5 22.5-gram sulfamethazine prolonged-re- consecutive days. Follow dosages care- lease bolus. fully. Do not treat cattle within 10 (2) Conditions of use—(i) Amount. De- days of slaughter. Do not use in female pending on the duration of therapeutic dairy cattle 20 months of age or older. levels desired, administer boluses as a Use of sulfamethazine in this class of single dose as follows: 31⁄2 days—1 bolus cattle may cause milk residues. A (22.5 grams) per 200 pounds of body withdrawal period has not been estab- weight; 5 days—1 bolus per 100 pounds lished in preruminating calves. Do not of body weight. use in calves to be processed for veal. (ii) Indications for use. Beef and non- Do not use in horses intended for lactating cattle for sustained treat- human consumption. ment of shipping fever pneumonia (b)(1) Sponsor. See No. 053501 in caused or complicated by Pasteurella § 510.600(c) of this chapter for use of 5- multocida; as an aid in the treatment of gram sulfamethazine bolus. foot rot, mastitis, pneumonia, metritis, (2) Related tolerances in edible prod- bacterial enteritis, calf diphtheria, and ucts. See § 556.670 of this chapter. septicemia when caused or complicated (3) Conditions of use—(i) Amount. Ad- by bacteria susceptible to minister 10 grams (2 boluses) of sulfamethazine. sulfamethazine per 100 pounds of body (iii) Limitations. Cattle that are weight the first day, then 5 grams (1 acutely ill should be treated bolus) of sulfamethazine per 100 pounds parenterally with a suitable anti- of body weight daily for up to 4 addi- bacterial product to obtain immediate tional consecutive days. therapeutic blood levels; do not slaugh- (ii) Indications for use. Ruminating ter animals for food within 16 days of beef and dairy calves. For treatment of treatment; do not use in lactating the following diseases caused by orga- dairy cattle; Federal law restricts this nisms susceptible to sulfamethazine: drug to use by or on the order of a li- bacterial scours (colibacilloosis) caused censed veterinarian. by E. coli; necrotic pododermatitis (foot (b)(1) Sponsor. See No. 053501 in rot) and calf diphtheria caused by F. § 510.600(c) of this chapter for use of a necrophorum; bacterial pneumonia asso- 27-gram sulfamethazine sustained-re- ciated with Pasteurella spp.; and coc- lease bolus. cidiosis caused by E. bovis and E. zurnii. (2) Conditions of use—(i) Amount. 27 (iii) Limitations. Do not administer grams (1 bolus) for each 150 pounds of for more than 5 consecutive days. Do body weight as a single dose. not treat calves within 11 days of (ii) Indications for use. For nonlac- slaughter. Do not use in calves to be tating cattle for the treatment of in- slaughtered under 1 month of age or in fections caused by organisms sensitive calves being fed an all milk diet. Do to sulfamethazine such as hemorrhagic not use in female dairy cattle 20 septicemia (shipping fever complex),

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bacterial pneumonia, foot rot, and calf (d)(1) Sponsor. See 000859 in § 510.600(c) diphtheria and as an aid in the control of this chapter for use of a 22.5-gram of bacterial diseases usually associated sulfamethazine sustained release bolus. with shipping and handling of cattle. (2) Conditions of use—(i) Amount. Ad- (iii) Limitations. If no response within minister 1 bolus (22.5 grams) per 200 2 to 3 days, reevaluate therapy; do not pounds of body weight, as a single dose. crush tablets; treated animals must (ii) Indications for use. Beef and non- not be slaughtered for food within 28 lactating dairy cattle for the prolonged days after the latest treatment; Fed- treatment of the following diseases eral law restricts this drug to use by or when caused by one or more of the list- on the order of a licensed veterinarian. (c)(1) Sponsor. See No. 061623 in ed pathogenic organisms sensitive to § 510.600(c) of this chapter for use of a sulfamethazine: bovine respiratory dis- 32.1-gram sustained-release bolus. ease complex (shipping fever complex) (2) Conditions of use—(i) Amount. 32.1 (Pasteurella spp.), bacterial pneumonia grams (1 bolus) per 200 pounds of body (Pasteurella spp.), necrotic weight.1 pododermatitis (foot rot) (ii) Indications for use. For beef and (Fusobacterium necrophorum), nonlactating dairy cattle for the treat- colibacillosis (bacterial scours) ment of diseases caused by (Escherichia coli), calf diphtheria sulfamethazine-sensitive organisms as (Fusobacterium necrophorum), acute follows: bacterial pneumonia and bo- mastitis (Streptococcus spp.) and acute vine respiratory disease complex (ship- metritis (Streptococcus spp.). ping fever complex) caused by (iii) Limitations. Cattle that are Pasteurella spp., colibacillosis (bac- acutely ill should be treated by injec- terial scours) caused by E. coli, necrotic tion with a suitable antibacterial prod- pododermatitis (foot rot) and calf diph- uct to obtain immediate therapeutic theria caused by Fusobacterium blood levels; do not slaughter animals necrophorum, and acute mastitis and for food within 16 days of treatment; do acute metritis caused by Streptococcus not use in lactating dairy cattle; if spp.)1 treated animals do not respond within (iii) Limitations. After 72 hours, all animals should be reexamined for per- 2 to 3 days, consult a veterinarian. sistence of observable disease signs. If (e)(1) Sponsor. See No. 061623 in signs are present, consult a veteri- § 510.600(c) of this chapter for use of an narian. It is strongly recommended 8.02-gram sulfamethazine sustained-re- that a second dose be given to provide lease bolus. for an additional 72 hours of therapy, (2) Conditions of use—(i) Amount. Ad- particularly in more severe cases. The minister 2 boluses (8.02 grams per dosage schedule should be used at each bolus) per 100 pounds of body weight, as 72-hour interval. Animals should not a single dose. receive more than 2 doses because of (ii) Indications for use. Administer the possibility of incurring residue vio- orally to ruminating calves for the pro- lations. This drug, like all longed treatment of the following dis- sulfonamides, may cause toxic reac- eases when caused by one or more of tions and irreparable injury unless ad- the listed pathogenic organisms sen- ministered with adequate and contin- sitive to sulfamethazine: bacterial uous supervision; follow dosages care- pneumonia (Pasteurella spp.), fully. Fluid intake must be adequate at colibacillosis (bacterial scours) (E. all times throughout the 3-day ther- coli), and calf diptheria (Fusobacterium apy, Do not use in lactating dairy cat- necrophorum). tle. Do not treat animals within 12 (iii) Limitations. For use in rumi- days of slaughter. nating replacement calves only; 72 hours after dosing all animals should 1 These conditions are NAS/NRC reviewed be reexamined for persistence of dis- and found effective. Applications for these uses need not inlcude effectiveness data as ease signs; if signs are present, consult specified by § 514.111 of this chapter, but may a veterinarian; do not slaughter ani- require bioequivalency and safety informa- mals for food for at least 12 days after tion. the last dose; this product has not been

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shown to be effective for nonrumi- ceptible to sulfamethazine: bacterial nating calves; exceeding two consecu- pneumonia associated with Pasteurella tive doses may cause violative tissue spp.; colibacillosis (bacterial scours) residue to remain beyond the with- caused by Escherichia coli; coccidiosis drawal time; do not use in calves under caused by Eimeria bovis and E. zurnii; 1 month of age or calves being fed an and calf diphtheria caused by all milk diet. Fusobacterium necrophorum. (f)(1) Sponsor. See No. 000859 in (iii) Limitations. Do not use in calves § 510.600(c) of this chapter for use of a to be slaughtered under 1 month of age 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 grams per bolus) per 200 pounds of body persist after 3 days, consult a veteri- weight, as a single dose. narian. Do not administer more than 2 (ii) Indications for use. Administer consecutive doses. Do not slaughter orally to beef cattle and nonlactating animals for food for at least 8 days dairy cattle for the treatment of the after the last dose. Do not crush bolus. following diseases when caused by one [46 FR 36132, July 14, 1981, as amended at 48 or more of the listed pathogenic orga- FR 18803, Apr. 26, 1983; 48 FR 32760, July 19, nisms sensitive to sulfamethazine: bo- 1983; 49 FR 29057, July 18, 1984; 50 FR 49372, vine respiratory disease complex (ship- Dec. 2, 1985; 51 FR 30212, Aug. 25, 1986; 53 FR ping fever complex) associated with 40727, Oct. 18, 1988; 54 FR 14341, Apr. 11, 1989; Pasteurella spp.; bacterial pneumonia 55 FR 8462, Mar. 8, 1990; 56 FR 50653, Oct. 8, associated with Pasteurell spp.; necrotic 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. pododermatitis (foot rot) and calf diph- 9, 1996; 62 FR 35076, June 30, 1997; 66 FR 14073, theria caused by Fusobacterium Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 70 FR necrophorum; colibacillosis (bacterial 8290, Feb. 18, 2005; 78 FR 17596, Mar. 22, 2013] scours) caused by Escherichia coli; coccidiosis caused by Eimeria bovis and E. § 520.2260c Sulfamethazine sustained- release tablets. zurnii; acute mastitis and metritis caused by Streptococcus spp. (a) Sponsor. See No. 053501 in (iii) Limitations. For use in beef cattle § 510.600(c) of this chapter for use of an and nonlactating dairy cattle only; if 8-gram sulfamethazine sustained-re- symptoms persist for 2 or 3 days after lease tablet. use, consult a veterinarian; do not (b) Conditions of use—(1) Amount. 8 slaughter animals for food for at least grams (1 tablet) per 45 pounds of body 8 days after the last dose; do not use in weight as a single dose. lactating dairy cattle; do not admin- (2) Indications for use. In calves for ister more than two consecutive doses. sustained treatment of pneumonia (g) Related tolerances. See § 556.670 of caused by Pasteurella spp., this chapter. colibacillosis (bacterial scours) caused (h)(1) Sponsor. See No. 000010 in by Escherichia coli; and calf diptheria § 510.600(c) of this chapter for use of an caused by Fusobacterium necrophorum. 8.25-gram sulfamethazine sustained-release bolus. (3) Limitations. If there is no response (2) Conditions of use—(i) Amount. Ad- within 2 to 3 days, reevaluate therapy. minister at the rate of 1 bolus (8.25 Do not crush tablets. Treated animals grams per bolus) per 50 pounds of body must not be slaughtered for food with- weight, as a single dose. If signs of dis- in 18 days after the latest treatment. ease are significantly reduced, it is rec- Federal law restricts this drug to use ommended that a second dose be given by or on the order of a licensed veteri- to provide an additional 72 hours of narian. therapy. [48 FR 26763, June 10, 1983, as amended at 56 (ii) Indications for use. Administer FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; orally to ruminating beef and dairy 61 FR 4875, Feb. 9, 1996] calves for treatment of the following diseases when caused by one or more of the listed pathogenic organisms sus-

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§ 520.2261 Sulfamethazine sodium oral amount of medication to one-half for 4 dosage forms. additional days. (3) Limitations. Add the required dose § 520.2261a Sulfamethazine solution. to that amount of water that will be (a) Sponsors. See Nos. 000010 and consumed in 1 day. Consumption 061623 in § 510.600(c) of this chapter for should be carefully checked. Have only use of a 12.5-percent sulfamethazine so- medicated water available during dium solution. treatment. Withdraw medication from (b) Related tolerances in edible prod- cattle, chickens, and turkeys 10 days ucts. See § 556.670 of this chapter. prior to slaughter for food. Withdraw (c) 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. bovine respiratory disease complex (d) NAS/NRC status. The conditions of (shipping fever complex) (Pasteurella use specified in this section have been spp.), colibacillosis (bacterial scours) reviewed by NAS/NRC and are found ef- (Escherichia coli), necrotic fective. Applications for these uses pododermatitis (foot rot) need not include effectiveness data as (Fusobacterium necrophorum), calf diph- specified by § 514.111 of this chapter, theria (Fusobacterium necrophorum), but may require bioequivalency and acute mastitis (Streptococcus spp.), and safety information. acute metritis (Streptococcus spp.). [47 FR 25322, June 11, 1982, as amended at 47 (ii) Swine. Treatment of porcine FR 25735, June 15, 1982; 67 FR 78355, Dec. 24, colibacillosis (bacterial scours) 2002; 70 FR 32489, June 3, 2005; 74 FR 36112, (Escherichia coli), and bacterial pneu- July 22, 2009; 75 FR 10166, Mar. 5, 2010; 76 FR monia (Pasteurella spp.). 17337, Mar. 29, 2011] (iii) Chickens and turkeys. In chickens for control of infectious coryza § 520.2261b Sulfamethazine powder. (Avibacterium paragallinarum), coccidi- (a) Specifications. A soluble powder osis (Eimeria tenella, Eimeria necatrix), composed of 100 percent sulfamethazine acute fowl cholera (Pasteurella sodium. multocida), and pullorum disease (b) Sponsors. See Nos. 000010 and (Salmonella pullorum). In turkeys for 061623 in § 510.600(c) of this chapter. control of coccidiosis (Eimeria (c) Related tolerances. See § 556.670 of meleagrimitis, Eimeria adenoeides). Medi- this chapter. cate as follows: Infectious coryza in (d) Conditions of use—(1) Chickens—(i) chickens, medicate for 2 consecutive Amount. Administer in drinking water days; acute fowl cholera and pullorum to provide 58 to 85 milligrams (mg) per disease, in chickens, medicate for 6 pound (/lb) of body weight per day. consecutive days; coccidiosis, in chick- (ii) Indications for use. For control of ens and turkeys, medicate as in para- infectious coryza (Haemophilus graph (c) of this section, then reduce gallinarum), coccidiosis (Eimeria tenella,

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E. necatrix), acute fowl cholera tuted early. Treatment should con- (Pasteurella multocida), and pullorum tinue 24 to 48 hours beyond the remis- disease (Salmonella pullorum). sion of disease symptoms, but not to (iii) Limitations. Add the required exceed a total of 5 consecutive days. dose to that amount of water that will Medicated swine must actually con- be consumed in 1 day. Consumption sume enough medicated water which should be carefully checked. Have only provides the recommended dosages. medicated water available during (4) Cattle—(i) Amount. Administer in treatment. Withdraw medication 10 drinking water, or as a drench, to pro- days prior to slaughter for food. Do not vide 108 mg/lb of body weight on the medicate chickens producing eggs for first day and 54 mg/lb of body weight human consumption. Treatment of all per day on the second, third, and fourth diseases should be instituted early. days of administration. Treatment should continue 24 to 48 (ii) Indications for use in beef and non- hours beyond the remission of disease lactating dairy cattle. Treatment of bac- symptoms. Medicated chickens must terial pneumonia and bovine res- actually consume enough medicated piratory disease complex (shipping water which provides the recommended fever complex) (Pasteurella spp.), dosages. colibacillosis (bacterial scours) (E. (2) Turkeys—(i) Amount. Administer coli), necrotic pododermatitis (foot rot) in drinking water to provide 50 to 124 (Fusobacterium necrophorum), calf diph- mg/lb of body weight per day theria (F. necrophorum), acute mastitis (ii) Indications for use. For control of (Streptococcus spp.), and acute metritis coccidiosis (E. meleagrimitis, E. (Streptococcus spp.) adenoeides). (iii) Limitations. Add the required (iii) Limitations. Add the required dose to that amount of water that will dose to that amount of water that will be consumed in 1 day. Consumption be consumed in 1 day. Consumption should be carefully checked. Have only should be carefully checked. Have only medicated water available during medicated water available during treatment. Withdraw medication 10 treatment. Withdraw medication 10 days prior to slaughter for food. Treat- days prior to slaughter for food. Do not ment of all diseases should be insti- medicate turkeys producing eggs for tuted early. Treatment should con- human consumption. Treatment of all tinue 24 to 48 hours beyond the remis- diseases should be instituted early. sion of disease symptoms, but not to Treatment should continue 24 to 48 exceed a total of 5 consecutive days. hours beyond the remission of disease Medicated cattle must actually con- symptoms. Medicated turkeys must ac- sume enough medicated water which tually consume enough medicated provides the recommended dosages. water which provides the recommended [71 FR 70303, Dec. 4, 2006, as amended at 75 dosages. FR 10166, Mar. 5, 2010] (3) Swine—(i) Amount. Administer in drinking water, or as a drench, to pro- § 520.2280 Sulfamethizole and methe- vide 108 mg/lb of body weight on the namine mandelate tablets. first day and 54 mg/lb of body weight (a) Specifications. Each tablet con- per day on the second, third, and fourth tains 250 milligrams of sulfamethizole days of administration. and 250 milligrams of methenamine (ii) Indications for use. For treatment mandelate. of porcine colibacillosis (bacterial (b) Sponsor. See No. 000856 in scours) (E. coli), and bacterial pneu- § 510.600(c) of this chapter. monia (Pasteurella spp.). (c) Conditions of use. (1) The drug is (iii) Limitations. Add the required indicated for the treatment of urinary dose to that amount of water that will tract infections in dogs and cats such be consumed in 1 day. Consumption as cystitis, nephritis, prostatitis, ure- should be carefully checked. Have only thritis, and pyelonephritis. It is also medicated water available during used as an aid in the management of treatment. Withdraw medication 15 complications resulting from surgical days prior to slaughter for food. Treat- manipulations of the urinary tract ment of all diseases should be insti- such as removal of calculi from the

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bladder, in ureterostomies, and in in- change litter unless absolutely nec- strumentation of the urethra and blad- essary. Do not give flushing mashes. der. (2) Turkeys. (i) As an aid in the con- (2) It is administered at a dosage trol of outbreaks of coccidiosis caused level of one tablet for each 20 pounds of by Eimeria meleagrimitis and E. body weight given three times per day. adenoeides. The drug should be given until all signs (ii) Administer at the 0.025 percent are alleviated. To reduce the possi- level for 2 days, skip 3 days, give for 2 bility of a relapse, it is suggested that days, skip 3 days and give for 2 more therapy be continued for a further pe- days. Repeat if necessary. Do not riod of a week to 10 days. change litter unless absolutely nec- (3) Federal law restricts this drug to essary. Do not give flushing mashes. use by or on the order of a licensed vet- (3) Chickens and turkeys. (i) As an aid erinarian. in the control of acute fowl cholera caused by Pasteurella multocida suscep- [40 FR 13838, Mar. 27, 1975, as amended at 50 tible to sulfaquinoxaline and fowl ty- FR 13561, Apr. 5, 1985] phoid caused by Salmonella gallinarum susceptible to sulfaquinoxaline. § 520.2325 Sulfaquinoxaline oral dosage forms. (ii) Administer at the 0.04 percent level for 2 or 3 days. Move birds to § 520.2325a Sulfaquinoxaline drinking clean ground. If disease recurs, repeat water. treatment. If cholera has become established as the respiratory or chronic (a) Sponsor. See § 510.600(c) of this form, use feed medicated with chapter for identification of the spon- sulfaquinoxaline. Poultry which have sors. survived typhoid outbreaks should not (1) To No. 000859 for use of a 25-per- be kept for laying house replacements cent sulfaquinoxaline soluble powder or breeders unless tests show they are and a 20-percent sulfaquinoxaline so- not carriers. dium solution as provided for in para- (4) Cattle and calves. (i) For the con- graph (c) of this section. trol and treatment of outbreaks of coc- (2) To No. 061623 for use of 3.44- and cidiosis caused by Eimeria bovis or E. 12.85-percent sulfaquinoxaline sodium zurnii. solutions as provided for in paragraphs (ii) Administer at the 0.015-percent (c)(1), (c)(2), (c)(3), (c)(4)(i), and (c)(4)(ii) level for 3 to 5 days in drinking water of this section. medicated with sulfaquinoxaline solu- (3) To No. 046573 for use of a 31.92-per- tion. cent sulfaquinoxaline solution (sodium (iii) In lieu of treatment as provided and potassium salts) as provided for in in paragraph (e)(4)(ii) of this section, paragraphs (c)(1), (c)(2), (c)(3), (c)(4)(i), administer 1 teaspoon of 25-percent and (c)(4)(ii) of this section. sulfaquinoxaline soluble powder per (4) No. 053501 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. Consult a veterinarian (c)(3) of this section. or poultry pathologist for diagnosis. (b) Related tolerances. See § 556.685 of May cause toxic reactions unless the this chapter. drug is evenly mixed in water at dos- (c) Conditions of use. It is used in ages indicated and used according to drinking water as follows: directions. For control of outbreaks of (1) Chickens. (i) As an aid in the con- disease, medication should be initiated trol of outbreaks of coccidiosis caused as soon as the diagnosis is determined. by Eimeria tenella, E. necatrix, E. Medicated chickens, turkeys, cattle, acervulina, E. maxima, and E. brunetti. and calves must actually consume (ii) Administer at the 0.04 percent enough medicated water which pro- level for 2 or 3 days, skip 3 days then vides a recommended dosage of ap- administer at the 0.025 percent level for proximately 10 to 45 milligrams per 2 more days. If bloody droppings ap- pound per day in chickens, 3.5 to 55 pear, repeat treatment at the 0.025 per- milligrams per pound per day in tur- cent level for 2 more days. Do not keys, and approximately 6 milligrams

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per pound per day in cattle and calves § 520.2330 Sulfisoxazole tablets. depending on the age, class of animal, (a) Specifications. Each tablet con- ambient temperature, and other fac- tains 260 milligrams (4 grains) of tors. A withdrawal period has not been sulfisoxazole. established for sulfaquinoxaline in (b) Sponsor. See No. 000856 in preruminating calves. Do not use in § 510.600(c) of this chapter. calves to be processed for veal. Not for (c) Conditions of use—(1) Amount. Ad- use in lactating dairy cattle. Do not minister one tablet orally per 4 pounds give to chickens, turkeys or cattle of body weight. 1 within 10 days of slaughter for food. Do (2) Indications for use. Use in dogs and not medicate chickens or turkeys pro- cats as an aid in treatment of bacterial ducing eggs for human consumption. pneumonia and bacterial enteritis Make fresh drinking water daily. when caused by organisms sensitive to sulfisoxazole. 1 [48 FR 3964, Jan. 28, 1983, as amended at 48 (3) Limitations. Repeat dosage at 24- FR 26762, June 10, 1983; 55 FR 29843, July 23, hour intervals until 2 to 3 days after 1990; 59 FR 28769, June 3, 1994; 59 FR 33197, disappearance of clinical symptoms. June 28, 1994; 61 FR 24443, May 15, 1996; 61 FR 63711, Dec. 2, 1996; 62 FR 37712, July 15, 1997; (Administration of one-half daily dos- 65 FR 10705, Feb. 29, 2000; 69 FR 41427, July 9, age at 12-hour intervals or one-third 2004; 69 FR 60547, Oct. 12, 2004; 74 FR 36112, daily dosage at 8-hour intervals will July 22, 2009; 78 FR 17596, Mar. 22, 2013] provide a more constant blood level.) Provide adequate supply of drinking § 520.2325b Sulfaquinoxaline drench. water. If symptoms persist after using this preparation for 2 or 3 days, consult (a)–(b) [Reserved] a veterinarian. 1 (c) Sponsor. See No. 050749 in § 510.600(c) of this chapter. [43 FR 60895, Dec. 29, 1978] (d) NAS/NRC status. The conditions of § 520.2340 Tepoxalin. use specified in this section have been reviewed by NAS/NRC and are found ef- (a) Specifications. Each tablet con- fective. Applications for these uses tains 30, 50, 100, or 200 milligrams (mg) need not include effectiveness data as tepoxalin. specified by § 514.111 of this chapter, (b) Sponsor. See No. 000061 in but may require bioequivalency infor- § 510.600(c) of this chapter. mation. Applications must be accom- (c) Conditions of use in dogs—(1) panied by a written commitment to un- Amount. 10 mg per kilogram (/kg) daily; or 20 mg/kg on the initial day of treat- dertake the human safety studies re- ment, followed by 10 mg/kg daily. quired by FDA. (2) Indications for use. For the control (e) Conditions of uses. As a 25-percent of pain and inflammation associated sulfaquinoxaline soluble powder. with osteoarthritis. (1) For the control and treatment of (3) Limitations. Federal law restricts outbreaks of coccidiosis in cattle and this drug to use by or on the order of a calves caused by Eimeria bovis or E. licensed veterinarian. zurnii. [68 FR 34795, June 11, 2003] (2) Give one teaspoon of 25 percent sulfaquinoxaline soluble powder for § 520.2345 Tetracycline. each 125 pounds of body weight for 3 to 5 days as a drench. § 520.2345a Tetracycline hydrochloride (f) Limitations. For control of out- capsules. breaks of disease, medication should be (a) Specifications. Each capsule con- initiated as soon as the diagnosis is de- tains 50, 100, 125, 250, or 500 milligrams termined. Consult a veterinarian for di- (mg) tetracycline hydrochloride. agnosis. Do not give to cattle within 10 days of slaughter for food. Not for use 1 These conditions are NAS/NRC reviewed in lactating dairy cattle. and deemed effective. Applications for these uses need not include effectiveness data as [48 FR 3964, Jan. 28, 1983, as amended at 55 specified by § 514.111 of this chapter, but may FR 29843, July 23, 1990; 59 FR 33197, June 28, require bioequivalency and safety informa- 1994] tion.

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(b) Sponsor. See sponsors in 000009 in § 510.600(c) of this chapter for § 510.600(c) of this chapter for use as in use as in paragraph (d)(2) of this sec- paragraph (c) of this section: tion. (1) No. 000009: 250 mg per capsule. (c) Related tolerances. See § 556.720 of (2) No. 000069: 125, 250, or 500 mg per this chapter. capsule. (d) Conditions of use. Calves—(1) (c) Conditions of use in dogs—(1) Amount. 10 milligrams per pound of Amount. 25 mg per pound of body body weight per day in divided doses. weight per day in divided doses every 6 (i) Indications for use. Control and hours. treatment of bacterial enteritis (2) Indications for use. For treatment (scours) caused by E. coli and bacterial of infections caused by organisms sen- pneumonia caused by Pasteurella spp., sitive to tetracycline hydrochloride, Hemophilus spp., and Klebsiella spp. such as bacterial gastroenteritis due to (ii) Limitations. Administer orally for E. coli and urinary tract infections due 3 to 5 days; do not slaughter animals to Staphylococcus spp. and E. coli. for food within 14 days of treatment; (3) Limitations. Federal law restricts use as sole source of tetracycline. this drug to use by or on the order of a (iii) National Academy of Sciences/Na- licensed veterinarian. tional Research Council (NAS/NRC) sta- [70 FR 50182, Aug. 26, 2005, as amended at 73 tus. The conditions of use specified in FR 18442, Apr. 4, 2008] paragraph (d)(1)(i) of this section were NAS/NRC reviewed and found effective. § 520.2345b Tetracycline tablets. Applications for these uses need not in- (a) Specifications. Each tablet conclude effectiveness data as specified in tains 100, 250, or 500 milligrams of tet- § 514.111 of this chapter, but may re- racycline (as the hydrochloride). quire bioequivalency and safety infor- (b) Sponsor. For 100, 250, or 500 milli- mation. grams per tablet, see No. 000069 in (2) Amount. 10 milligrams per pound § 510.600(c) of this chapter. For 250 mil- of body weight per day in two divided ligrams per tablet, see No. 000009 in doses. § 510.600(c) of this chapter. (i) Indications for use. Treatment of (c) Conditions of use. Dogs—(1) bacterial pneumonia caused by orga- Amount. 25 milligrams per pound of nisms susceptible to tetracycline, bac- body weight per day in divided doses terial enteritis caused by E. coli, and every 6 hours. salmonella organisms susceptible to (2) Indications for use. Treatment of tetracycline. infections caused by organisms sen- (ii) Limitations. Administer orally for sitive to tetracycline hydrochloride, not more than 5 days; do not slaughter such as bacterial gastroenteritis due to animals for food within 12 days of E. coli and urinary tract infections due treatment; use as sole source of tetra- to Staphylococcus spp. and E. coli. cycline. (3) Limitations. Administer orally; [57 FR 37328, Aug. 18, 1992, as amended at 67 continue treatment until symptoms of FR 78355, Dec. 24, 2002] the disease have subsided and temperature is normal for 48 hours; not for use § 520.2345d Tetracycline powder. in animals raised for food production; (a) Specifications. Each pound of pow- Federal law restricts this drug to use der contains 25, 102.4, or 324 grams tet- by or on the order of a licensed veteri- racycline hydrochloride. narian. (b) Sponsors. See sponsors listed in [57 FR 37327, Aug. 18, 1992] § 510.600(c) of this chapter for conditions of use as in paragraph (d) of this § 520.2345c Tetracycline boluses. section: (a) Specifications. Each bolus contains (1) No. 000069: 25 grams per pound as 500 milligrams of tetracycline (as the in paragraphs (d)(3) and (d)(4) of this hydrochloride). section. (b) Sponsors. See No. 053501 in (2) No. 054628: 25, 102.4, and 324 grams § 510.600(c) of this chapter for use as in per pound as in paragraph (d) of this paragraph (d)(1) of this section. See No. section.

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(3) No. 046573: 25, 102.4, and 324 grams (iii) Limitations. Administer for 7 to per pound as in paragraph (d) of this 14 days; do not slaughter for food with- section. in 4 days of treatment; not for use in (4) Nos. 054925, 057561, 061623, and chickens producing eggs for human 076475: 324 grams per pound as in para- consumption; prepare a fresh solution graph (d) of this section. daily; use as the sole source of tetra- (c) Related tolerances. See § 556.720 of cycline. this chapter. (4) Turkeys—(i) Amount. For infec- (d) Conditions of use. It is adminis- tious synovitis: 400 milligrams per gal- tered in drinking water as follows: lon. For complicating bacterial orga- (1) Calves—(i) Amount. 10 milligrams nisms associated with bluecomb (trans- per pound of body weight per day in di- missible enteritis or coronaviral enter- vided doses. itis): 25 milligrams per pound of body (ii) Indications for use. Control and weight per day. treatment of bacterial enteritis (ii) Indications for use. Control of in- (scours) caused by and Escherichia coli fectious synovitis caused by M. bacterial pneumonia (shipping fever synoviae; control of bluecomb com- complex) associated with Pasteurella plicated by organisms sensitive to tet- spp., Actinobacillus pleuropneumoniae racycline. (Hemophilus spp.), and Klebsiella spp., susceptible to tetracycline. (iii) Limitations. Administer for 7 to (iii) Limitations. Administer for 3 to 5 14 days; do not slaughter for food with- days; do not slaughter animals for food in 4 days of treatment; not for use in within 4 days of treatment for No. turkeys producing eggs for human con- 000010 and within 5 days of treatment sumption; prepare a fresh solution for Nos. 046573, 054925, 057561, 059130, and daily; use as the sole source of tetra- 061623; prepare a fresh solution daily; cycline. use as the sole source of tetracycline. [59 FR 17693, Apr. 14, 1994, as amended at 59 A withdrawal period has not been es- FR 19133, Apr. 22, 1994; 62 FR 5319, Feb. 5, tablished for this product in 1997; 62 FR 35076, June 30, 1997; 62 FR 46668, preruminating calves. Do not use in Sept. 4, 1997; 62 FR 55160, Oct. 23, 1997; 64 FR calves to be processed for veal. 37673, July 13, 1999; 67 FR 78355, Dec. 24, 2002; (2) Swine—(i) Amount. 10 milligrams 70 FR 16934, Apr. 4, 2005; 70 FR 67353, Nov. 7, per pound of body weight per day in di- 2005; 71 FR 13542, Mar. 16, 2006; 75 FR 10166, Mar. 5, 2010; 75 FR 12981, Mar. 18, 2010; 76 FR vided doses. 17338, Mar. 29, 2011; 77 FR 20988, Apr. 9, 2012; (ii) Indications for use. Control and 78 FR 21060, Apr. 9, 2013] treatment of bacterial enteritis (scours) caused by E. coli and bacterial § 520.2345e Tetracycline oral liquid. pneumonia associated with Pasteurella (a) Specifications. Each milliliter con- spp., A. pleuropneumoniae (Hemophilus spp.), and Klebsiella spp., susceptible to tains the equivalent of either 25 or 100 tetracycline. milligrams of tetracycline hydro- (iii) Limitations. Administer for 3 to 5 chloride. days; do not slaughter animals for food (b) Sponsor. See No. 000069, in within 7 days of treatment for No. § 510.600(c) of this chapter for use of 25 000010 and within 4 days of treatment or 100 milligrams per milliliter liquid for Nos. 046573, 054925, 057561, 059130, and in dogs as in paragraph (c)(1) of this 061623; prepare a fresh solution daily; section; see No. 000009 in § 510.600(c) of use as the sole source of tetracycline. this chapter for use of 100 milligrams (3) Chickens—(i) Amount. Chronic res- per milliliter liquid in dogs and cats as piratory disease: 400 to 800 milligrams in paragraph (c)(2). per gallon. Infectious synovitis: 200 to (c) Conditions of use—(1) Dogs—(i) 400 milligrams per gallon. Amount. 25 milligrams per pound of (ii) Indications for use. Control of body weight per day in divided doses chronic respiratory disease (CRD or every 6 hours. air-sac disease) caused by Mycoplasma (ii) Indications for use. Treatment of gallisepticum and E. coli; control of in- infections caused by organisms sen- fectious synovitis caused by M. sitive to tetracycline hydrochloride, synoviae susceptible to tetracycline. such as bacterial gastroenteritis due to

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Escherichia coli and urinary tract infec- evidence of infection has disappeared. tions due to Staphylococcus spp. and E. As with all antibiotics, appropriate in coli. vitro culturing and susceptibility tests (iii) Limitations. Administer orally; of samples taken before treatment continue treatment until symptoms should be conducted. Federal law re- have subsided and the temperature is stricts this drug to use by or on the normal for 48 hours; not for use in ani- order of a licensed veterinarian. mals which are raised for food production; Federal law restricts this drug to [57 FR 37329, Aug. 18, 1992] use by or on the order of a licensed veterinarian. § 520.2345g Tetracycline hydrochloride and sodium novobiocin tablets. (iv) National Academy of Sciences/Na- tional Research Council (NAS/NRC) sta- (a) Specifications. Each tablet con- tus. These conditions were NAS/NRC tains the equivalent of 60 milligrams of reviewed and found effective. Applica- tetracycline hydrochloride and 60 mil- tions for these uses need not include ef- ligrams of novobiocin, or 180 milli- fectiveness data as specified by § 514.111 grams of tetracycline hydrochloride of this chapter, but may require bio- and 180 milligrams of novobiocin. equivalency and safety information. (b) Sponsor. No. 000009 in § 510.600(c) of (2) Dogs and cats—(i) Amount. 25 milli- this chapter. grams per pound of body weight per (c) Conditions of use. Dogs—(1) day in divided doses every 6 hours. Amount. 10 milligrams of each anti- (ii) Indications for use. Treatment of biotic per pound of body weight (one infections caused by organisms suscep- single-strength tablet for each 6 pounds tible to tetracycline hydrochloride, or one triple-strength tablet for each 18 such as bacterial gastroenteritis due to pounds). E. coli and urinary tract infections due (2) Indications for use. Treatment of to Staphylococcus spp. and E. coli. acute or chronic canine respiratory in- (iii) Limitations. Administer orally; fections such as tonsillitis, bronchitis, continue treatment until the tempera- and tracheobronchitis when caused by ture has been normal for 48 hours; not pathogens susceptible to tetracycline for use in food-producing animals; Fed- and/or novobiocin, such as Staphy- eral law restricts this drug to use by or lococcus spp. and Escherichia coli. on the order of a licensed veterinarian. (3) Limitations. Continue treatment [57 FR 37329, Aug. 18, 1992] for at least 48 hours after the temperature has returned to normal and all § 520.2345f Tetracycline phosphate evidence of infection has disappeared. complex and sodium novobiocin As with all antibiotics, appropriate in capsules. vitro culturing and susceptibility tests (a) Specifications. Each capsule con- of samples taken before treatment tains the equivalent of 60 milligrams of should be conducted. Federal law re- tetracycline hydrochloride and 60 mil- stricts this drug to use by or on the ligrams of novobiocin. order of a licensed veterinarian. (b) Sponsor. No. 000009 in § 510.600(c) of this chapter. [57 FR 37329, Aug. 18, 1992] (c) Conditions of use. Dogs—(1) Amount. 10 milligrams of each anti- § 520.2345h Tetracycline hydro- biotic per pound of body weight (1 cap- chloride, sodium novobiocin, and prednisolone tablets. sule for each 6 pounds) every 12 hours. (2) Indications for use. Treatment of (a) Specifications. Each tablet con- acute or chronic canine respiratory in- tains the equivalent of 60 milligrams of fections such as tonsillitis, bronchitis, tetracycline hydrochloride, 60 milli- and tracheobronchitis when caused by grams of novobiocin, and 1.5 milli- pathogens susceptible to tetracycline grams of prednisolone or 180 milli- and/or novobiocin, such as Staphy- grams of tetracycline hydrochloride, lococcus spp. and Escherichia coli. 180 milligrams of novobiocin, and 4.5 (3) Limitations. Continue treatment milligrams of prednisolone. for at least 48 hours after the tempera- (b) Sponsor. See No. 000009 in ture has returned to normal and all § 510.600(c) of this chapter.

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(c) Conditions of use. Dogs—(1) cies Ancylostoma caninum and Uncinaria Amount. 10 milligrams of each anti- stenocephala (hookworms). Dogs weigh- biotic and 0.25 milligram of prednis- ing 10 pounds and over are adminis- olone per pound of body weight (one tered 1 tablet as a single dose. Dogs single-strength tablet for each 6 pounds weighing 5 to 10 pounds are adminis- or one triple-strength tablet for each 18 tered one-half tablet twice during a pounds) every 12 hours for 48 hours. single day. All dosages are given for 1 Treatment is to be continued with day only. The treatment should be re- novobiocin and tetracycline alone at peated after 2 or 3 weeks. the same dose schedule for an addi- (2) Suckling puppies or recently tional 3 days or longer as needed. weaned puppies weighing less than 5 (2) Indications for use. Treatment of pounds should not be treated with the acute and chronic canine respiratory drug. Animals that are severely in- infections such as tonsillitis, bron- fected, exhibiting evidence of intes- chitis, and tracheobronchitis when tinal hemorrhage, debilitation, and caused by pathogens susceptible to tet- anemia, should be given supportive racycline and/or novobiocin, such as treatment. Staphylococcus spp. and Escherichia coli, (3) Federal law restricts this drug to when it is necessary to initially reduce use by or on the order of a licensed vet- the severity of associated clinical erinarian. signs. (3) Limitations. As with all anti- [40 FR 13838, Mar. 27, 1975, as amended at 41 biotics, appropriate in vitro culturing FR 53477, Dec. 7, 1976; 46 FR 48642, Oct. 2, 1981; and susceptibility tests of samples 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997] taken before treatment should be conducted. Administer for 48 hours only. § 520.2380 Thiabendazole oral dosage Continue treatment if needed with tet- forms. racycline/novobiocin alone. The product is contraindicated in animals with § 520.2380a Thiabendazole top dress- tuberculosis, hyperadrenocorticalism, ing and mineral protein block. or peptic ulcers. Clinical and experi- (a) Chemical name. 2-(4-Thiazolyl)- mental data have demonstrated that benzimidazole. corticosteroids administered orally or (b) Specifications. Conforms to N.F. parenterally to animals may induce XII. the first stage of parturition when ad- (c) Sponsors. See sponsors in ministered during the last trimester of § 510.600(c) of this chapter for use as in pregnancy and may precipitate pre- paragraph (e) of this section. mature parturition followed by (1) No. 051311 for use as in paragraph dystocia, fetal death, retained pla- (e)(1)(i) of this section. centa, and metritis. Federal law re- (2) No. 050604 for use as in paragraph stricts this drug to use by or on the (e)(1)(ii) of this section. order of a licensed veterinarian. (3) No. 012286 for use as in paragraph [57 FR 37329, Aug. 18, 1992] (e)(2) of this section. (d) Related tolerances. See § 556.730 of § 520.2362 Thenium closylate tablets. this chapter. (a) Chemical name. (N,N-Dimethyl-N- (e) Conditions of use. It is used as fol- 2-phenoxyethyl-N-2′-thenylammo- lows: nium)-p-chlorobenzene-sulfonate. (1) Horses—(i) Route of administration. (b) Specifications. Thenium closylate In feed, as a top dressing. tablets contain thenium closylate (a) Amount. 2 grams per 100 pounds of equivalent to 500 milligrams thenium body weight. as base in each tablet. (b) Indications for use. For control of (c) Sponsor. See No. 000061 in large strongyles, small strongyles, § 510.600(c) of this chapter. pinworms, and threadworms (including (d) Conditions of use. (1) The tablets members of the genera Strongylus, are administered orally to dogs as a Cyathostomum, Cylicobrachytus, and re- single day treatment of canine ancylo- lated genera, Craterostomum, stomiasis by the removal from the in- Oesophagodontus, Poteriostomum, testines of the adult forms of the spe- Oxyuris, and Strongyloides).

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(c) Limitations. Add to the usual feed narian consulted for advice concerning of horses mixed into that amount of treatment. the feed normally consumed at one [40 FR 13838, Mar. 27, 1975, as amended at 41 feeding. Warning: Not for use in horses FR 9149, Mar. 3, 1976; 62 FR 63271, Nov. 28, intended for food. 1997; 70 FR 32489, June 3, 2005; 73 FR 35340, (ii) Route of administration. In feed. June 23, 2008] (a) Amount. 2 grams per 100 pounds of body weight. § 520.2380b Thiabendazole drench or oral paste. (1) Indications for use. For control of large and small strongyles, (a) Chemical name. 2-(4-Thiazolyl) Strongyloides, and pinworms of the gen- benzimidazole. era Strongylus, Cyathostomum, (b) Specifications. Conforms to N.F. Cylicobrachytus and related genera, XII. Craterostomum, Oesophagodontus, (c) Sponsor. See No. 050604 in Poteriostomum, Oxyuris, and § 510.600(c) of this chapter for the spon- Strongyloides. sor of the usages provided for by paragraph (e) of this section. (2) Limitations. Administer in a single dosage mixed with the normal grain ra- (d) Related tolerances. See § 556.730 of this chapter. tion given at one feeding. Warning: Not (e) Conditions of use. It is used as fol- for use in horses intended for food. lows: (b) Amount. 4 grams per 100 pounds of (1) Horses. As a single liquid oral body weight. dose, administered as a drench or by (1) Indications for use. For control of stomach tube; or as an oral paste. ascarids of the genus Parascaris. (i) Amount. 2 grams per 100 pounds of (2) Limitations. Administer in a single body weight. dosage mixed with the normal grain ra- (a) Indications for use. For the control tion given at one feeding. Warning: Not of infections of large strongyles for use in horses intended for food. (Strongylus vulgaris, Strongylus (2) Cattle—(i) Route of administration. endentatus), small strongyles In feed block. (Cyathastomum, Cylicobrachytus and re- (ii) Amount. 3.3 percent block con- lated genera, Craterostomum, sumed at the recommended level of 0.11 Oesophagodontus, Poteriostomum), pound per 100 pounds of body weight pinworms (Oxyuris), and threadworms per day. (Strongyloides). (iii) Indications for use. For control of (b) Limitations. Not for use in horses infections of gastrointestinal to be slaughtered for food purposes. roundworms (Trichostrongylus, When administered by stomach tube, Haemonchus, Ostertagia and Cooperia). for use only by or on the order of a li- (iv) Limitations. Administer to cattle censed veterinarian. When for use as a on pasture or range accustomed to liquid oral drench or an oral paste, consult your veterinarian for assistance in mineral protein block feeding for 3 the diagnosis, treatment, and control days. Milk taken from animals during of parasitism. treatment and within 96 hours (8 (ii) Amount. 4 grams per 100 pounds of milkings) after the latest treatment body weight. must not be used for food. Do not treat (a) Indications for use. For control of cattle within 3 days of slaughter. For a infections of ascardis (Parascaris). satisfactory diagnosis, a microscopic (b) Limitations. Not for use in horses fecal examination should be performed to be slaughtered for food purposes. by a veterinarian or diagnostic labora- When administered by stomach tube, tory prior to worming. Animals main- use only by or on the order of a li- tained under conditions of constant censed veterinarian. When for use as a worm exposure may require re-treat- liquid oral drench or an oral paste, con- ment within 2 to 3 weeks. Animals that sult your veterinarian for assistance in are severely parasitized, sick, or off the diagnosis, treatment, and control feed should be isolated and a veteri- of parasitism. (2) Pigs. As an oral paste.

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(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 Ostertagia spp., and Oesophagostomum sheep, treatment should be repeated in radiatum). 2 to 3 weeks. (5) Orally, as a drench. (b) Limitations. For most effective re- Goats. sults, severely parasitized animals or (i) Amount. 3 grams per 100 pounds of those constantly exposed to helminth body weight. infection should be re-treated every 2 (ii) Indications for use. Control of se- to 3 weeks. Milk taken from treated vere infections of gastrointestinal animals within 96 hours (8 milkings) roundworms (Trichostrongylus spp., after the latest treatment must not be Haemonchus spp., Ostertagia spp., used for food. Do not treat cattle with- Cooperia spp., Nematodirus spp., in 3 days of slaughter. For a satisfac- Bunostomum spp., Strongyloides spp., tory diagnosis, a microscopic fecal ex- Chabertia spp., and Oesophagostomum amination should be performed prior to spp. ). worming. (iii) Limitations. As a single oral dose; (ii) Amount. 5 grams per 100 pounds of do not treat animals within 30 days of body weight. slaughter; milk taken from treated animals within 96 hours (8 milkings) (a) Indications for use. Control of in- after the latest treatment must not be fections of Cooperia spp. or severe infec- used for food; treatment should be re- tions of other species in paragraph peated in 2 to 3 weeks. (e)(3)(i)(a) of this section. (b) Limitations. For most effective re- [40 FR 13838, Mar. 27, 1975, as amended at 41 sults, severely parasitized animals or FR 9149, Mar. 3, 1976; 41 FR 47424, Oct. 29, those constantly exposed to helminth 1976; 62 FR 63271, Nov. 28, 1997] infection should be re-treated every 2 to 3 weeks. Milk taken from treated § 520.2380c Thiabendazole bolus. animals within 96 hours (8 milkings) (a) Chemical name. 2-(4-Thiazolyl) after the latest treatment must not be benzimidazole. used for food. Do not treat cattle with- (b) Specifications. Conforms to N.F. in 3 days of slaughter. For a satisfac- XII. tory diagnosis, a microscopic fecal ex- (c) Sponsor. See No. 050604 in amination should be performed prior to § 510.600(c) of this chapter. worming. (d) Related tolerances. See § 556.730 of (4) Sheep and goats. Orally, as a this chapter. drench. (e) Conditions of use. It is used as fol- (i) Amount. 2 grams per 100 pounds of lows: body weight. (1) Cattle. In a bolus.

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(i) Amount. 3 grams per 100 pounds of (i) Amount. 3 grams per 100 pounds of body weight. body weight. (a) Indications for use. Control of in- (ii) Indications for use. Control of se- fections of gastrointestinal vere infections of gastrointestinal roundworms (general Trichostrongylus roundworms (genera Trichostrongylus spp., Haemonchus spp., Nematodirus spp., spp., Haemonchus spp., Ostertagia spp., Ostertagia spp., and Oesophagostomum Cooperia spp., Nematodirus spp., radiatum). Bunostomum spp., Strongyloides spp., (b) Limitations. As a single oral dose; Chabertia spp., and Oesophagostomum may repeat once in 2 to 3 weeks; do not spp. ). treat animals within 3 days of slaugh- (iii) Limitations. As a single oral dose; ter; milk taken from treated animals do not treat animals within 30 days of within 96 hours (8 milkings) after the slaughter; milk taken from treated latest treatment must not be used for animals within 96 hours (8 milkings) food. after the latest treatment must not be (ii) Amount. 5 grams per 100 pounds of used for food; treatment should be re- body weight. peated in 2 to 3 weeks. (a) Indications for use. Control of severe infections of gastrointestinal [40 FR 13838, Mar. 27, 1975, as amended at 41 FR 9149, Mar. 3, 1976; 62 FR 63271, Nov. 28, roundworms (genera Trichostrongylus 1997] spp., Haemonchus spp., Nematodirus spp., Ostertagia spp., and Oesophagostomum § 520.2380d Thiabendazole, piperazine radiatum). Control of infections with citrate suspension. Cooperia spp. (a) Specifications. Each fluid ounce of (b) Limitations. As a single oral dose; suspension contains 2 grams of as a drench or bolus; may repeat once thiabendazole and 2.5 grams of piper- in 2 to 3 weeks; do not treat animals azine (from piperazine citrate). within 3 days of slaughter; milk taken (b) Sponsor. See No. 050604 in from treated animals within 96 hours (8 § 510.600(c) of this chapter. milkings) after the latest treatment (c) Conditions of use. (1) It is adminis- must not be used for food. tered to horses by stomach tube or as a (2) Sheep and goats. In a bolus. drench at the rate of 1 fluid ounce of (i) Amount. 2 grams per 100 pounds of suspension per 100 pounds of body body weight. weight for the control of large (ii) Indications for use. Control of in- strongyles, small strongyles, fections of gastrointestinal pinworms, Strongyloides and ascarids roundworms in sheep and goats (gen- (including members of the genera eral Trichostrongylus spp., Haemonchus Strongylus spp., Cyathostomum spp., spp., Ostertagia spp., Cooperia spp., Cylicobrachytus spp. and related genera Nematodirus spp., Bunostomum spp., Craterostomum spp., Oesophagodontus Strongyloides spp., Chabertia spp., and spp., Poteriostomum spp., Oxyuris spp., Oesophagostomum spp. ); also active Strongyloides spp., and Parascaris spp. ). from 3 hours to 3 days following treat- (2) Do not use in horses intended to ment against ova and larvae passed by be used for food purposes. sheep (good activity against T. (3) For use by or on the order of a li- colubriformis and axei, Ostertagia spp., censed veterinarian. Bunostomum spp., Nematodirus spp., and Strongyloides spp.; less effective against [40 FR 13838, Mar. 27, 1975, as amended at 62 Haemonchus contortus and FR 63271, Nov. 28, 1997] Oesophagostomum spp. ). (iii) Limitations. As a single oral dose; § 520.2380e Thiabendazole with do not treat animals within 30 days of trichlorfon. slaughter; milk taken from treated (a) Specifications. The drug contains 5 animals within 96 hours (8 milkings) grams of thiabendazole with 4.5 grams after the latest treatment must not be of trichlorfon, or 20 grams of used for food; in severe infections in thiabendazole with 18 grams of sheep, treatment should be repeated in trichlorfon. 2 to 3 weeks. (b) Sponsor. See No. 017135 in (3) Goats. In a bolus. § 510.600(c) of this chapter.

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(c) Conditions of use. (1) Used for the (Strongyloides), and ascarids (Parascaris) treatment and control of bots in horses. (Gasterophilus spp. ), large strongyles (3) Limitations. Use a single oral dose. (Strongylus spp. ), small strongyles Administer as a drench or by stomach (genera Cyathostomum, Cylicobrachytus, tube suspended in 1 pint of warm Craterostomum, Oesophagodontus, water; by dose syringe suspended in 1⁄2 Poteriostomum), pinworms (Oxyuris spp., ounce of water for each 100 pounds of Strongyloides spp. ), and ascarids body weight; or sprinkled over a small (Parascaris spp. ) in horses. amount of daily feed. Not for animals (2) Administer 2 grams of intended for food use. If the label bears thiabendazole with 1.8 grams of directions for administration by stom- trichlorfon per 100 pounds of body ach tube or drench, it shall also bear weight sprinkled on the animals’ usual the statement ‘‘Caution: Federal law daily ration of feed, or may be mixed in restricts this drug to use by or on the 5 to 10 fluid ounces of water and admin- order of a licensed veterinarian;’’ if not istered by stomach tube or drench. labeled for use by stomach tube or (3) Do not re-treat more than once drench, the label shall bear the state- every 30 days, preferably every 6 to 8 ment, ‘‘Consult your veterinarian for weeks. assistance in the diagonosis, treat- (4) Do not treat animals if sick or de- ment, and control of parasitism.’’ bilitated; less than 4 months of age; or mares in last month of pregnancy. [46 FR 18963, Mar. 27, 1981, as amended at 46 (5) Do not administer intravenous an- FR 52330, Oct. 27, 1981; 62 FR 63271, Nov. 28, 1997] esthetics, especially muscle relaxants, within 2 weeks of use. § 520.2455 Tiamulin. (6) Not for animals intended for food use. (a) Specifications. (1) Each gram of (7) Do not use within a few days be- soluble powder contains 450 milligrams fore or after treatment with or expo- (mg) tiamulin hydrogen fumarate. sure to cholinesterase-inhibiting drugs, (2) Each milliliter (mL) of solution pesticides, or chemicals. contains 125 mg (12.5 percent) tiamulin (8) If the label bears directions for ad- hydrogen fumarate. ministration of the drug by stomach (3) Each mL of solution contains 123 tube or drench it shall also bear the mg (12.3 percent) tiamulin hydrogen fu- statement: Caution; Federal law re- marate. stricts this drug to use by or on the (b) Sponsors. See sponsor numbers in order of a licensed veterinarian. § 510.600(c) of this chapter for use as in paragraph (d) of this section. [40 FR 23071, May 28, 1975, as amended at 48 FR 48229, Oct. 18, 1983] (1) No. 058198 for products described in paragraphs (a)(1) and (a)(2) of this § 520.2380f Thiabendazole, piperazine section. phosphate powder. (2) No. 066104 for the product de- (a) Specifications. Each ounce of water scribed in paragraph (a)(1) of this sec- dispersible powder contains 6.67 grams tion. of thiabendazole and 8.33 grams of pi- (3) No. 000859 for the product de- perazine (as piperazine phosphate). scribed in paragraph (a)(3) of this sec- (b) Sponsor. See No. 050604 in tion. § 510.600(c) of this chapter. (c) Related tolerances. See § 556.738 of (c) Conditions of use—(1) Amount. 2 this chapter. grams of thiabendazole and 2.5 grams (d) Conditions of use in swine—(1) of piperazine (0.3 ounce of powder) per Amounts and indications for use. Admin- 100 pounds of body weight. ister in drinking water for 5 consecu- (2) Indications for use. Treatment of tive days: infections of large strongyles (genus (i) 3.5 mg per (/) lb of body weight Strongylus), small strongyles (genera daily for treatment of swine dysentery Cyathostomum, Cylicobrachytus, and re- associated with Brachyspira lated genera Craterostomum, hyodysenteriae susceptible to tiamulin. Oesophagodontus, Poteriostomum), (ii) 10.5 mg/lb of body weight daily for pinworms (Oxyuris), threadworms treatment of swine pneumonia due to

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Actinobacillus pleuropneumoniae suscep- (c) Conditions of use—(1) Horses—(i) tible to tiamulin. Amount. 5 milligrams per pound of body (2) Limitations. Use as only source of weight as a single dose. drinking water. Prepare fresh medi- (ii) Indications for use. Removal of cated water daily. Withdraw medica- mature large strongyles (Strongylus tion 3 days before slaughter following edentatus, S. equinus, and S. vulgaris), treatment at 3.5 mg/lb and 7 days be- mature ascarids (Parascaris equorum), fore slaughter following treatment at mature and immature (4th larval 10.5 mg/lb of body weight. Swine being stage) pinworms (Oxyuris equi), and ma- treated with tiamulin should not have ture small strongyles (Triodontophorus access to feeds containing polyether spp.). ionophores (e.g., lasalocid, monensin, (iii) Limitations. For administration narasin, salinomycin, or with feed: Sprinkle required amount of semduramycin) as adverse reactions granules on a small amount of the may occur. The effects of tiamulin on usual grain ration and mix. Prepare for swine reproductive performance, preg- each horse individually. Withholding of nancy, and lactation have not been de- feed or water not necessary. Not for termined. use in horses intended for food. The reproductive safety of tioxidazole in [70 FR 75017, Dec. 19, 2005, as amended at 74 FR 7180, Feb. 13, 2009; 75 FR 54492, Sept. 8, breeding animals has not been deter- 2010; 77 FR 56770, Sept. 14, 2012; 78 FR 17596, mined. Consult your veterinarian for Mar. 22, 2013] assistance in the diagnosis, treatment, and control of parasitism. It is rec- § 520.2471 Tilmicosin. ommended that this drug be adminis- (a) Specifications. Each milliliter of tered with caution to sick or debili- concentrate solution contains 250 milli- tated horses. grams (mg) tilmicosin as tilmicosin (2) [Reserved] phosphate. [50 FR 52772, Dec. 26, 1985; 51 FR 2693, Jan. 21, (b) Sponsor. See No. 000986 in 1986, as amended at 52 FR 7832, Mar. 13, 1987] § 510.600(c) of this chapter. (c) Tolerances. See § 556.735 of this § 520.2473b Tioxidazole paste. chapter. (a) Specifications. Each plastic syringe (d) Conditions of use in swine—(1) contains 6.25 grams of tioxidazole. Amount. Administer in drinking water (b) Sponsor. See No. 000061 in at a concentration of 200 mg per liter § 510.600(c) of this chapter. for 5 consecutive days. (c) Conditions of use—(1) Horses—(i) (2) Indication for use. For the control Amount. 5 milligrams of tioxidazole per of swine respiratory disease associated pound of body weight as a single dose. with Pasteurella multocida and (ii) Indications for use. Removal of Haemophilus parasuis in groups of swine mature large strongyles (Strongylus in buildings where a respiratory dis- edentatus, S. equinus, and S. vulgaris), ease outbreak is diagnosed. mature ascarids (Parascaris equorum), (3) Limitations. Swine intended for mature and immature (4th larval human consumption must not be stage) pinworms (Oxyuris equi), and ma- slaughtered within 7 days of the last ture small strongyles (Triodontophorus treatment with this product. Federal spp.). law restricts this drug to use by or on (iii) Limitations. Administer orally by the order of a licensed veterinarian. inserting the nozzle of the syringe [79 FR 18158, Apr. 1, 2014] through the space between front and back teeth and deposit the required § 520.2473 Tioxidazole oral dosage dose on the base of the tongue. Before forms. dosing, make sure the horse’s mouth contains no feed. Not for use in horses § 520.2473a Tioxidazole granules. intended for food. The reproductive (a) Specifications. Each gram of gran- safety of tioxidazole in breeding ani- ules contains 200 milligrams of mals has not been determined. Consult tioxidazole. your veterinarian for assistance in the (b) Sponsor. See No. 000061 in diagnosis, treatment, and control of § 510.600(c) of this chapter. parasitism. It is recommended that

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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, sprinkled (top-dressed) on a small portion of § 520.2475 Toceranib. 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. 000009 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 in- [75 FR 10166, Mar. 5, 2010] volvement. (iii) Limitations. Federal law restricts § 520.2520 Trichlorfon oral dosage this drug to use by or on the order of a forms. licensed veterinarian. (2) [Reserved] § 520.2520b Trichlorfon and atropine. (a) Chemical name. (1) For trichlorfon: [74 FR 28875, June 18, 2009] O,O-Dimethyl 2,2,2-trichloro-1-hy- § 520.2483 Triamcinolone. droxyethyl phosphonate. (2) For atropine: Atropine N.F. (a) Specifications.—(1) Each tablet (b) Sponsor. See No. 000856 in contains 0.5 milligram (mg) or 1.5 mg § 510.600(c) of this chapter. triamcinolone acetonide. (c) Conditions of use. (1) The drug is (2) Each 15 grams of powder contains used for the treatment of Syphacia 10 mg triamcinolone acetonide. obvelata (pinworm) in laboratory mice. (b) Sponsor. See No. 000010 in (2) It is administered in distilled § 510.600(c) of this chapter. water as sole source of drinking water (c) Special considerations. See § 510.410 continuously for 7 to 14 days at 1.67 of this chapter. grams of trichlorfon and 7.7 milligrams (d) Conditions of use—(1) Dogs and of atropine per liter. cats. Use tablets described in paragraph (3) Prepare fresh solution every 3 (a)(1) of this section as follows: days. Do not use simultaneously with (i) Amount. Administer 0.05 mg per other drugs, insecticides, pesticides, or pound (/lb) of body weight daily by chemicals having cholinesterase activ- mouth; up to 0.1 mg per pound (/lb) of ity, nor within 7 days before or after body weight daily, if response to the treatment with any other cholin- smaller dose is inadequate. Therapy esterase inhibitor. may be initiated with a single injec- (4) Restricted to use by or on the tion of triamcinolone acetonide sus- order of a licensed veterinarian. pension as in § 522.2483 of this chapter, in which case triamcinolone acetonide § 520.2520e Trichlorfon boluses. tablets should be administered begin- (a) Specifications. Each bolus contains ning 5 to 7 days after the injection. either 7.3, 10.9, 14.6, or 18.2 g of (ii) Indications for use. As an anti-in- trichlorfon. flammatory agent. (b) Sponsor. See 000856 in § 510.600(c) of (iii) Limitations. Federal law restricts this chapter. this drug to use by or on the order of a (c) Special considerations. Trichlorfon licensed veterinarian. is a cholinesterase inhibitor. Do not

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use this product on animals simulta- Gastrophilus intestinalis), large neously with, or within 2 weeks, before roundworms (ascarids, Parascaris or after treatment with or exposure to, equorum), and pinworms (Oxyuris equi). neuromuscular depolarizing agents (3) Limitations. Do not fast horses be- (i.e., succinylcholine) or to cholin- fore or after treatment. Treatment of esterase-inhibiting drugs, pesticides, or mares in late pregnancy is not rec- chemicals. ommended. Surgery or any severe (d) NAS/NRC status. Use of this drug stress should be avoided for at least 2 has been NAS/NRC reviewed and found weeks before or after treatment. Do effective. Applications for these uses not administer to sick, toxic, or debili- need not include effectiveness data as tated horses. Not to be used in horses specified by § 514.111 of this chapter. intended for use as food. Federal law (e) Conditions of use—(1) Amount. 18.2 restricts this drug to use by or on the milligrams per pound of body weight, order of a licensed veterinarian. except for strongyles use 36.4 milli- [45 FR 48128, July 18, 1980] grams per pound of body weight. (2) Indications for use. For horses for § 520.2520g Trichlorfon, phenothiazine, removal of bots (Gastrophilus nasalis, and piperazine dihydrochloride Gastrophilus intestinalis), large powder. strongyles (Strongylus vulgaris), small (a) Specifications. Each 54.10 grams strongyles, large roundworms (1.91 ounces) of water dispersible pow- (ascarids, Parascaris equorum), and der contains 9.10 grams of trichlorfon, pinworms (Oxyuris equi). 6.25 grams of phenothiazine, and the (3) Limitations. Do not fast horses be- equivalent of 20.0 grams of piperazine fore or after treatment. Treatment of base (as piperazine dihydrochloride). mares in late pregnancy is not rec- (b) Sponsor. See No. 000856 in ommended. Surgery or any severe § 510.600(c) of this chapter. stress should be avoided for at least 2 (c) Special considerations. Labeling weeks before or after treatment. Do shall bear the following statements: not administer to sick, toxic, or debili- The drug is a cholinesterase inhibitor. tated horses. Not to be used in horses Do not use this product in horses si- intended for use as food. Federal law multaneously with, or within 2 weeks restricts this drug to use by or on the before or after treatment with, or expo- order of a licensed veterinarian. sure to, neuromuscular depolarizing [45 FR 48127, July 18, 1980] agents (e.g., succinylcholine) or to cholinesterase-inhibiting drugs, pesticides, § 520.2520f Trichlorfon granules. or chemicals. (a) Specifications. Each package con- (d) Conditions of use—(1) Amount. 18.2 tains either 18.2 or 36.4 g of trichlorfon. milligrams of trichlorfon, 12.5 milli- (b) Sponsor. See 000856 in § 510.600(c) of grams of phenothiazine, and 40.0 milli- this chapter. grams of piperazine base per pound of (c) Special considerations. Trichlorfon body weight. is a cholinesterase inhibitor. Do not (2) Indications for use. For horses for use this product on animals simulta- removal of bots (Gastrophilus nasalis, neously with, or within 2 weeks before Gastrophilus intestinalis), large or after treatment with or exposure to strongyles (Strongylus vulgaris), small neuromuscular depolarizing agents strongyles, large roundworms (i.e., succinylcholine) or to cholin- (ascarids, Parascaris equorum), and esterase-inhibiting drugs, pesticides, or pinworms (Oxyuris equi). chemicals. (3) Limitations. Mix powder and vial (d) NAS/NRC status. Use of this drug contents together in warm water to has been NAS/NRC reviewed and found form suspension. Administer by stom- effective. Applications for these uses ach tube. Do not fast horses before or need not include effectiveness data as after treatment. Treatment of mares in specified by § 514.111 of this chapter. late pregnancy is not recommended. (e) Conditions of use—(1) Amount. 18.2 Surgery or any severe stress should be milligrams per pound of body weight. avoided for at least 2 weeks before or (2) Indications for use. For horses for after treatment. Do not administer to removal of bots (Gastrophilus nasalis, sick, toxic, or debilitated horses. Not

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to be used in horses intended for use as of hyperadrenocorticism due to food. Federal law restricts this drug to adrenocortical tumor. use by or on the order of a licensed vet- (3) Limitations. Federal law restricts erinarian. this drug to use by or on the order of a licensed veterinarian. [48 FR 2757, Jan. 21, 1983] [74 FR 21767, May 11, 2009, as amended at 74 § 520.2582 Triflupromazine hydro- FR 30464, June 26, 2009] chloride tablets. § 520.2604 Trimeprazine tartrate and (a) Specifications. Each tablet con- prednisolone tablets. tains either 10 milligrams or 25 milli- (a) Specifications. Each tablet con- grams of triflupromazine hydro- tains: trimeprazine tartrate, 5 milli- chloride. grams; and prednisolone, 2 milligrams. (b) Sponsor. See No. 053501 in (b) Sponsor. See No. 000069 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Conditions of use. (1) The drug is (c) Conditions of use. (1) The drug is used in dogs and cats to relieve anxiety administered orally to dogs for the re- and to help control psychomotor over- lief of itching regardless of cause; re- activity as well as to increase the tol- duction of inflammation commonly as- erance of animals to pain and pruritus. sociated with most skin disorders of The drug is indicated in various office dogs such as eczema, caused by inter- and clinical procedures which require nal disorders, otitis, and dermatitis, al- the aid of a tranquilizer, antiemetic, or lergic, parasitic, pustular and nonspe- preanesthetic.1 cific. It is also used in dogs as adjunc- (2) The drug is administered orally to tive therapy in various cough condi- dogs and cats at a dosage level of 1 to tions including treatment of ‘‘kennel 2 milligrams per pound of body weight cough’’ or tracheobronchitis, bron- daily; an initial dosage at the 2-milli- chitis including allergic bronchitis, in grams level is suggested followed by tonsillitis, acute upper respiratory in- daily doses at the 1-milligram level. fections and coughs of nonspecific ori- Frequently, the drug may be with- gin. The product may also be adminis- drawn after 4 to 5 days, with drug ef- tered to dogs suffering from acute or fect continuing after withdrawal.1 chronic bacterial infections, provided (3) Do not use in conjunction with the infection is controlled by appro- organophosphates and/or procaine hy- priate antibiotic or chemotherapeutic drochloride, because phenothiazines agents.1 may potentiate the toxicity of (2) The drug is administered orally at organophosphates and the activity of an initial dosage level of 1⁄2 tablet procaine hydrochloride.1 twice daily to dogs weighing up to 10 (4) Federal law restricts this drug to pounds, one tablet twice daily to dogs use by or on the order of a licensed vet- weighing 11 to 20 pounds, two tablets erinarian.1 twice daily to dogs weighing 21 to 40 pounds, and three tablets twice daily [40 FR 13838, Mar. 27, 1975, as amended at 50 to dogs weighing over 40 pounds. After FR 41489, Oct. 11, 1985] 4 days, the dosage is reduced to ap- 1 § 520.2598 Trilostane. proximately ⁄2 the initial dosage or to an amount just sufficient to maintain (a) Specifications. Each capsule con- remission of symptoms. Dosages in in- tains 10, 30, or 60 milligrams (mg) dividual cases may vary and should be trilostane. adjusted until proper response is ob- (b) Sponsor. See No. 043264 in § 510.600 tained.1 of this chapter. (3) Do not use the drug in cases of (c) Conditions of use in dogs—(1) viral infections involving corneal ul- Amount. The starting dose is 1.0 to 3.0 ceration or dendritic ulceration of the milligrams per pound (2.2 to 6.7 milli- cornea.1 grams per kilogram) once a day. (4) Clinical and experimental data (2) Indications for use. For treatment have demonstrated that corticosteroids of pituitary-dependent administered orally or parenterally to hyperadrenocorticism. For treatment animals may induce the first stage of

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parturition when administered during terial infections, provided the infection the last trimester of pregnancy and is controlled by appropriate antibiotic may precipitate premature parturition or chemotherapeutic agents. followed by dystocia, fetal death, re- (3) Limitations. After 4 days, reduce tained placenta, and metritis.1 dosage to one-half the initial dose or to (5) Federal law restricts this drug to an amount sufficient to maintain re- use by or on the order of a licensed vet- mission of symptoms. Dosages in indi- erinarian.1 vidual cases may vary and should be [40 FR 13838, Mar. 27, 1975, as amended at 56 adjusted until proper response is ob- FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, tained. Do not use the drug in cases of 1995] viral infections involving corneal ulceration or dendritic ulceration of the § 520.2605 Trimeprazine tartrate and cornea. Clinical and experimental data prednisolone capsules. have demonstrated that corticosteroids (a) Specifications. Each capsule con- administered orally or parenterally to tains 3.75 milligrams of trimeprazine in animals may induce the first stage of sustained released form (as the tar- parturition when administered during trate) and 1 milligram of prednisolone the last trimester of pregnancy and (capsule no. 1) or 7.5 milligrams of may precipitate premature parturition trimeprazine in sustained release form followed by dystocia, fetal death, re- (as the tartrate) and 2 milligrams of tained placenta, and metritis. Federal prednisolone (capsule no. 2). law restricts this drug to use by or on (b) Sponsor. See 000069 in § 510.600(c) of the order of a licensed veterinarian. this chapter. (c) Conditions of use—(1) Amount. Ad- [48 FR 19367, Apr. 29, 1983, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, minister either capsule orally once 1995] daily to dogs as follows:

Number of capsules § 520.2610 Trimethoprim and sulfa- per dose diazine tablets. Animal weight (pounds) Capsule Capsule (a) Specifications. Each tablet con- No. 1 No. 2 tains 30 milligrams (5 milligrams of Up to 10 ...... 1 ...... trimethoprim and 25 milligrams of sul- 11 to 20 ...... 2 1 fadiazine), 120 milligrams (20 milli- 21 to 40 ...... 4 2 grams of trimethoprim and 100 milli- Over 40 ...... 6 3 grams of sulfadiazine), 480 milligrams (80 milligrams of trimethoprim and 400 (2) Indications for use. For the relief of milligrams of sulfadiazine) or 960 milli- itching regardless of cause, reduction grams (160 milligrams of trimethoprim of inflammation commonly associated and 800 milligrams of sulfadiazine). with most skin disorders of dogs such as eczema caused by internal disorders, (b) Sponsor. See Nos. 000061 and 000856 otitis, and dermatitis (allergic, para- in § 510.600(c) of this chapter. sitic, pustular, and nonspecific). It is (c) Conditions of use. (1) The drug is also used in dogs as adjunctive therapy used in dogs where systemic anti- in various cough conditions including bacterial action against sensitive orga- treatment of ‘‘kennel cough’’ or nisms is required, either alone or as an tracheobronchitis, bronchitis including adjunct to surgery or debridement with allergic bronchitis, tonsillitis, acute associated infection. The drug is indi- upper respiratory infections, and cated where control of bacterial infec- coughs of nonspecific origin. The prod- tion is required during the treatment uct may also be administered to dogs of acute urinary tract infections, acute suffering from acute or chronic bac- bacterial complications of distemper, acute respiratory tract infections, acute alimentary tract infections, 1 These conditions are NAS/NRC reviewed wound infections, and abscesses. and deemed effective. Applications for these uses need not include effectiveness data as (2) The drug is given orally at 30 mil- specified by § 514.111 of this chapter, but may ligrams per kilogram of body weight require bioequivalency and safety informa- per day (14 milligrams per pound per tion. day), or as follows:

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(2) No. 000061 for product adminis- Animal body weight (pounds) Number of tablets tered as in paragraph (c)(1)(ii) of this

30 MG TABLETS section. (c) Conditions of use in horses—(1) 2.2 ...... 1 Amount. Administer orally as a single 4.4 ...... 2 daily dose for 5 to 7 days: 6.6 ...... 3 (i) 5 g of paste (335 mg trimethoprim 8.8 ...... 4 and 1,665 mg sulfadiazine) per 150 120 MG TABLETS pounds (68 kilograms) of body weight per day. Up to 9 ...... 1 (ii) 3.75 g of paste (250 mg 10 to 19 ...... 2 trimethoprim and 1,250 mg sulfa- 20 to 29 ...... 3 30 to 40 ...... 4 diazine) per 110 pounds (50 kilograms) of body weight per day. 480 MG TABLETS (2) Indications for use. For use where systemic antibacterial action against 30 to 40 ...... 1 40 to 60 ...... 11⁄2 sensitive organisms is required during 60 to 80 ...... 2 treatment of acute strangles, res- 80 to 110 ...... 3 piratory infections, acute urogenital Over 110 ...... 4 infections, and wound infections and abscesses. (3) The drug is given once daily. Al- (3) Limitations. Not for use in horses ternatively, especially in severe infec- intended for human consumption. Fed- tions, the initial dose may be followed eral law restricts this drug to use by or by one-half the recommended daily on the order of a licensed veterinarian. dose every 12 hours. If no improvement is seen in 3 days, discontinue therapy [71 FR 30802, May 31, 2006] and reevaluate diagnosis. § 520.2612 Trimethoprim and sulfa- (4) Administer for 2 to 3 days after diazine suspension. symptoms have subsided. Do not treat for more than 14 consecutive days. (a) Specifications. Each milliliter (mL) of suspension contains: (5) During long term treatment, peri- (1) 10 milligrams (mg) trimethoprim odic platelet counts and white and red and 50 mg sulfadiazine; or blood cell counts are recommended. (2) 400 mg combined active ingredi- (6) The drug should not be used in pa- ents (67 mg trimethoprim and 333 mg tients showing marked liver paren- sulfadiazine). chymal damage or blood dyscrasia, nor (b) Sponsors. See sponsor numbers in in those with a history of sulfonamide § 510.600 of this chapter: sensitivity. (1) No. 000061 for use of product de- (7) Federal law restricts this drug to scribed in paragraph (a)(1) for use as in use by or on the order of a licensed vet- paragraph (c)(1) of this section. erinarian. (2) No. 051072 for use of product de- [41 FR 3853, Jan. 27, 1976, as amended at 44 scribed in paragraph (a)(2) for use as in FR 32214, June 5, 1979; 46 FR 23231, Apr. 24, paragraph (c)(2) of this section. 1981; 47 FR 36814, Aug. 24, 1982; 50 FR 9800, (c) Conditions of use—(1) Dogs—(i) Mar. 12, 1985; 50 FR 11852, Mar. 26, 1985; 61 FR Amount. Administer 1 mL (10 mg 5506, Feb. 13, 1996; 61 FR 8873, Mar. 6, 1996; 62 trimethoprim and 50 mg sulfadiazine) FR 61625, Nov. 19, 1997] per 5 pounds (lb) of body weight once daily, or one-half the recommended § 520.2611 Trimethoprim and sulfadiazine paste. daily dose every 12 hours, for up to 14 consecutive days. (a) Specifications. Each gram (g) of (ii) Indications for use. The drug is paste contains 67 milligrams (mg) used in dogs where systemic anti- trimethoprim and 333 mg sulfadiazine. bacterial action against sensitive orga- (b) Sponsors. See sponsors in nisms is required, either alone or as an § 510.600(c) of this chapter: adjunct to surgery or debridement with (1) No. 000856 for product adminis- associated infection. The drug is indi- tered as in paragraph (c)(1)(i) of this cated where control of bacterial infec- section. tion is required during the treatment

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of acute urinary tract infections, acute trate equivalent to either 100 or 256 bacterial complications of distemper, grams tylosin base. acute respiratory tract infections, (b) Sponsors. See Nos. 000986, 016592, acute alimentary tract infections, and 061623 in § 510.600(c) of this chapter. wound infections, and abscesses. (1) No. 000986 for use of a 100-gram jar (iii) Limitations. Federal law restricts as in paragraph (d) of this section. this drug to use by or on the order of a (2) No. 016592 for use of a 100-gram jar licensed veterinarian. or pouch as in paragraphs (d)(1), (d)(2), (2) Horses—(i) Amount. Administer 24 (d)(3)(i), (d)(3)(ii)(B), (d)(3)(iii), and mg combined active ingredients per (d)(4) of this section. kilogram of body weight (2.7 mL/100 lb) (3) No. 061623 for use of a 100- or 256- twice daily for 10 days. gram jar or pouch as in paragraphs (ii) Indications for use. For the treat- (d)(1), (d)(2), (d)(3)(i), (d)(3)(ii)(B), ment of lower respiratory tract infec- (d)(3)(iii), and (d)(4) of this section. tions in horses caused by susceptible (c) Related tolerances. See § 556.740 of strains of Streptococcus equi subsp. this chapter. zooepidemicus. (d) Conditions of use—(1) Chickens—(i) (iii) Limitations. Do not use in horses Amount. 2 grams per gallon for 1 to 5 intended for human consumption. Fed- days as the sole source of drinking eral law restricts this drug to use by or water. Treated chickens should con- on the order of a licensed veterinarian. sume enough medicated drinking water [78 FR 63872, Oct. 25, 2013] to provide 50 milligrams (mg) tylosin per pound of body weight per day. § 520.2613 Trimethoprim and sulfa- (ii) Indications for use. For maintain- diazine powder. ing weight gain and feed efficiency in the presence of infectious sinusitis as- (a) Specifications. Each gram of pow- sociated with Mycoplasma gallisepticum der contains 67 milligrams of sensitive to tylosin. trimethoprim and 333 milligrams of sulfadiazine. (iii) Limitations. Prepare a fresh solution every 3 days. Do not use in layers (b) Sponsor. See No. 000009 and 058711 producing eggs for human consump- in § 510.600(c) of this chapter. tion. Do not administer within 24 hours (c) Conditions of use: Horses—(1) Dos- of slaughter. age. 3.75 grams of powder per 110 pounds (2) Turkeys—(i) Amount. 2 grams per (50 kilograms) of body weight per day. gallon for 2 to 5 days as the sole source (2) Indications for use. For control of of drinking water. Treated turkeys bacterial infections of horses during should consume enough medicated treatment of acute strangles, res- drinking water to provide 60 mg tylosin piratory tract infections, acute uro- per pound of body weight per day. genital infections, wound infections, (ii) Indications for use. For maintain- and abscesses. ing weight gains and feed efficiency in (3) Limitations. Administer orally in a the presence of infectious sinusitis as- small amount of feed, as a single daily sociated with Mycoplasma gallisepticum dose, for 5 to 7 days. Continue therapy sensitive to tylosin. for 2 to 3 days after clinical signs have (iii) Limitations. Prepare a fresh solu- subsided. If no improvement is seen in tion every 3 days. Do not use in layers 3 to 5 days, reevaluate diagnosis. A producing eggs for human consump- complete blood count should be done tion. Do not administer within 5 days periodically with prolonged use. Not of slaughter. for use in horses intended for food. Fed- eral law restricts this drug to use by or (3) Swine—(i) Amount. 250 mg per gal- on the order of a licensed veterinarian. lon as the only source of drinking water for 3 to 10 days, depending on the [58 FR 36135, July 6, 1993, as amended at 64 severity of the condition being treated. FR 68289, Dec. 7, 1999] (ii) Indications for use. (A) For the treatment and control of swine dys- § 520.2640 Tylosin. entery associated with Brachyspira (a) Specifications. Each container of hyodysenteriae when followed imme- soluble powder contains tylosin tar- diately by tylosin phosphate medicated

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feed; and for the control of porcine pro- (3) Limitations. Federal law restricts liferative enteropathies (PPE, ileitis) this drug to use by or on the order of a associated with Lawsonia intracellularis licensed veterinarian. when followed immediately by tylosin [77 FR 55415, Sept. 10, 2012] phosphate medicated feed. (B) For the treatment and control of PART 522—IMPLANTATION OR swine dysentery associated with Brachyspira hyodysenteriae. INJECTABLE DOSAGE FORM NEW (iii) Limitations. Prepare a fresh solu- ANIMAL DRUGS tion daily. Do not administer within 48 Sec. hours of slaughter. As indicated in 522.23 Acepromazine. paragraph (d)(3)(ii)(A) of this section, 522.52 Alfaxalone. follow with tylosin phosphate medi- 522.56 Amikacin. cated feed as in § 558.625(f)(1)(vi)(c) of 522.62 Aminopentamide. this chapter. 522.82 Aminopropazine. (4) Honey bees—(i) Amount. Mix 200 522.84 Beta-aminopropionitrile. milligrams tylosin in 20 grams confec- 522.88 Amoxicillin. 522.90 Ampicillin injectable dosage forms. tioners’/powdered sugar. Use imme- 522.90a Ampicillin trihydrate suspension. diately. Apply (dust) this mixture over 522.90b Ampicillin trihydrate powder for in- the top bars of the brood chamber once jection. weekly for 3 weeks. 522.90c Ampicillin sodium. (ii) Indications for use. For the control 522.144 Arsenamide. of American foulbrood (Paenibacillus 522.147 Atipamezole. 522.150 Azaperone. larvae). 522.161 Betamethasone. (iii) Limitations. The drug should be 522.163 Betamethasone dipropionate and fed early in the spring or fall and con- betamethasone sodium phosphate aque- sumed by the bees before the main ous suspension. honey flow begins, to avoid contamina- 522.204 Boldenone. tion of production honey. Complete 522.234 Butamisole. 522.246 Butorphanol. treatments at least 4 weeks before 522.275 N-Butylscopolammonium. main honey flow. 522.300 Carfentanil. 522.304 Carprofen. [40 FR 13838, Mar. 27, 1975, as amended at 50 522.311 Cefovecin. FR 49841, Dec. 5, 1985; 59 FR 14365, Mar. 28, 522.313 Ceftiofur injectable dosage forms. 1994; 62 FR 39443, July 23, 1997; 68 FR 24879, 522.313a Ceftiofur crystalline free acid. May 9, 2003; 70 FR 69439, Nov. 16, 2005; 73 FR 522.313b Ceftiofur hydrochloride. 76946, Dec. 18, 2008; 75 FR 76259, Dec. 8, 2010; 522.313c Ceftiofur sodium. 76 FR 59024, Sept. 23, 2011; 77 FR 29217, May 522.380 Chloral hydrate, pentobarbital, and 17, 2012] magnesium sulfate. 522.390 Chloramphenicol. § 520.2645 Tylvalosin. 522.460 Cloprostenol. (a) Specifications. Granules containing 522.468 Colistimethate sodium powder for 62.5 percent tylvalosin (w/w) as injection. 522.480 Corticotropin. tylvalosin tartrate. 522.518 Cupric glycinate injection. (b) Sponsor. See No. 066916 in 522.522 Danofloxacin. § 510.600(c) of this chapter. 522.533 Deslorelin. (c) Related tolerances. See § 556.748 of 522.535 Desoxycorticosterone. this chapter. 522.536 Detomidine. 522.540 Dexamethasone solution. (d) Conditions of use in swine—(1) 522.542 Dexamethasone suspension. Amount. Administer 50 parts per mil- 522.558 Dexmedetomidine. lion tylvalosin in drinking water for 5 522.563 Diatrizoate. consecutive days. 522.650 Dihydrostreptomycin sulfate injec- (2) Indications for use. For the control tion. of porcine proliferative enteropathy 522.690 Dinoprost solution. 522.723 Diprenorphine. (PPE) associated with Lawsonia 522.770 Doramectin. intracellularis infection in groups of 522.775 Doxapram. swine in buildings experiencing an out- 522.784 Doxylamine. break of PPE. 522.800 Droperidol and fentanyl.

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522.810 Embutramide, chloroquine, and lido- 522.1367 Meloxicam. caine solution. 522.1372 Mepivacaine. 522.812 Enrofloxacin. 522.1380 Methocarbamol. 522.814 Eprinomectin. 522.1410 Methylprednisolone. 522.820 Erythromycin. 522.1450 Moxidectin solution. 522.840 Estradiol. 522.1451 Moxidectin microspheres for injec- 522.842 Estradiol benzoate and testosterone tion. propionate. 522.1452 Nalorphine. 522.850 Estradiol valerate and norgestomet 522.1465 Naltrexone. in combination. 522.1468 Naproxen for injection. 522.863 Ethylisobutrazine. 522.1484 Neomycin. 522.870 Etodolac. 522.1503 Neostigmine. 522.883 Etorphine. 522.1610 Oleate sodium. 522.900 Euthanasia solution. 522.1620 Orgotein for injection. 522.914 Fenprostalene. 522.1660 Oxytetracycline injectable dosage 522.930 Firocoxib. forms. 522.955 Florfenicol. 522.1660a Oxytetracycline solution, 200 mil- 522.956 Florfenicol and flunixin. ligrams/milliliter. 522.960 Flumethasone injectable dosage 522.1660b Oxytetracycline solution, 300 mil- forms. ligrams/milliliter. 522.960a Flumethasone suspension. 522.1662 Oxytetracycline hydrochloride im- 522.960b Flumethasone acetate solution. plantation or injectable dosage forms. 522.960c Flumethasone solution. 522.1662a Oxytetracycline hydrochloride in- 522.970 Flunixin. jection. 522.995 Fluprostenol. 522.1662b Oxytetracycline hydrochloride 522.1002 Follicle stimulating hormone. with lidocaine injection. 522.1004 Fomepizole. 522.1662 Oxytetracycline and flunixin. 522.1010 Furosemide. 522.1680 Oxytocin. 522.1014 Gamithromycin. 522.1696 Penicillin G procaine injectable 522.1020 Gelatin. dosage forms. 522.1044 Gentamicin. 522.1696a Penicillin G benzathine and peni- 522.1066 Glycopyrrolate. cillin G procaine suspension. 522.1073 Gonadorelin acetate. 522.1696b Penicillin G procaine aqueous sus- 522.1075 Gonadorelin diacetate tetra- pension. hydrate. 522.1696c Penicillin G procaine in oil. 522.1077 Gonadorelin hydrochloride. 522.1698 Pentazocine. 522.1079 Serum gonadotropin and chorionic 522.1704 Pentobarbital. gonadotropin. 522.1720 Phenylbutazone. 522.1081 Chorionic gonadotropin for injec- 522.1820 Pituitary luteinizing hormone pow- tion; chorionic gonadotropin suspension. der for injection. 522.1083 Gonadotropin releasing factor ana- 522.1850 Polysulfated glycosaminoglycan. log-diphtheria toxoid conjugate. 522.1862 Pralidoxime powder for injection. 522.1085 Guaifenesin powder for injection. 522.1870 Praziquantel. 522.1086 Guaifenesin solution. 522.1881 Prednisolone acetate. 522.1125 Hemoglobin glutamer-200 (bovine). 522.1883 Prednisolone sodium phosphate. 522.1145 Hyaluronate. 522.1884 Prednisolone sodium succinate. 522.1150 Hydrochlorothiazide. 522.1885 Prednisolone tertiary butylacetate. 522.1155 Imidocarb powder for injection. 522.1890 Sterile prednisone suspension. 522.1156 Imidocarb solution. 522.1920 Prochlorperazine and isopropamide. 522.1160 Insulin. 522.1940 Progesterone and estradiol ben- 522.1182 Iron injection. zoate. 522.1185 Isoflupredone. 522.1962 Promazine. 522.1192 Ivermectin. 522.2002 Propiopromazine. 522.1193 Ivermectin and clorsulon. 522.2005 Propofol. 522.1204 Kanamycin. 522.2012 Prostalene. 522.1222 Ketamine. 522.2063 Pyrilamine. 522.1223 Ketamine, promazine, and 522.2076 Romifidine. aminopentamide. 522.2100 Selenium and vitamin E. 522.1225 Ketoprofen. 522.2112 Sometribove zinc suspension. 522.1242 Levamisole. 522.2120 Spectinomycin dihydrochloride in- 522.1260 Lincomycin. jection. 522.1289 Lufenuron. 522.2121 Spectinomycin sulfate. 522.1290 Luprostiol. 522.2150 Stanozolol. 522.1315 Maropitant. 522.2200 Sulfachlorpyridazine. 522.1335 Medetomidine. 522.2220 Sulfadimethoxine. 522.1350 Melatonin implant. 522.2240 Sulfaethoxypyridazine. 522.1362 Melarsomine powder for injection. 522.2260 Sulfamethazine.

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522.2340 Sulfomyxin. venous injection over approximately 60 522.2404 Thialbarbitone sodium for injec- seconds or until clinical signs show the tion. onset of anesthesia, 2.2 to 9.7 mg/kilo- 522.2424 Thiamylal. gram (kg) for cats that did not receive 522.2444 Thiopental injectable dosage forms. 522.2444a Thiopental powder for injection. a preanesthetic or 1.0 to 10.8 mg/kg for 522.2444b Thiopental and pentobarbital pow- cats that received a preanesthetic. der for injection. (B) Maintenance of general anesthesia 522.2460 Tildipirosin. following induction. Administer an in- 522.2470 Tiletamine and zolazepam for injec- travenous bolus containing 1.1 to 1.3 tion. mg/kg to provide an additional 7 to 8 522.2471 Tilmicosin. minutes of anesthesia in 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. 522.2477 Trenbolone acetate and estradiol. 3 to 5 minutes anesthesia in 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. that did not receive a preanesthetic or 522.2640 Tylosin. 0.2 to 3.5 mg/kg for dogs that received 522.2662 Xylazine. 522.2670 Yohimbine. a preanesthetic. 522.2680 Zeranol. (B) Maintenance of general anesthesia 522.2690 Zinc gluconate. following induction. Administer an intravenous bolus containing 1.2 to 1.4 AUTHORITY: 21 U.S.C. 360b. mg/kg to provide an additional 6 to 8 SOURCE: 40 FR 13858, Mar. 27, 1975, unless minutes of anesthesia in otherwise noted. preanesthetized dogs; a dose of 1.5 to 2.2 mg/kg provides an additional 6 to 8 § 522.23 Acepromazine. minutes of anesthesia in (a) Specifications. Each milliliter of unpreanesthetized dogs. solution contains 10 milligrams (mg) (2) Indications for use. For the induc- acepromazine maleate. tion and maintenance of anesthesia (b) Sponsors. See Nos. 000010 and and for induction of anesthesia fol- 000859 in § 510.600(c) of this chapter: lowed by maintenance with an inhalant (c) Conditions of use in dogs, cats, and anesthetic, in dogs and cats. horses—(1) Amount. Dogs: 0.25 to 0.5 mg (3) Limitations. Federal law restricts per pound (/lb) of body weight; Cats: 0.5 this drug to use by or on the order of a to 1.0 mg/lb of body weight; Horses: 2.0 licensed veterinarian. to 4.0 mg per 100 lbs of body weight. [77 FR 64717, Oct. 23, 2012] (2) Indications for use. For use as a tranquilizer and as a preanesthetic § 522.56 Amikacin. agent. (a) Specifications. Each milliliter of (3) Limitations. Do not use in horses solution contains 50 milligrams (mg) of intended for human consumption. Fed- amikacin as amikacin sulfate. eral law restricts this drug to use by or (b) Sponsor. See No. 000859 in on the order of a licensed veterinarian. § 510.600(c) of this chapter. [75 FR 10167, Mar. 5, 2010; 78 FR 17597, Mar. 22, (c) Conditions of use in dogs—(1) 2013; 79 FR 16182, Mar. 25, 2014] Amount. 5 mg/pound (lb) of body weight twice daily by intramuscular or sub- § 522.52 Alfaxalone. cutaneous injection. (a) Specifications. Each milliliter con- (2) Indications for use. For treatment tains 10 milligrams (mg) alfaxalone. of genitourinary tract infections (cys- (b) Sponsor. See No. 049480 in titis) caused by susceptible strains of § 510.600(c) of this chapter. Escherichia coli and Proteus spp. and (c) Conditions of use in cats and dogs— skin and soft tissue infections caused (1) Amount—(i) Cats—(A) Induction of by susceptible strains of Pseudomonas general anesthesia. Administer by intra- spp. and E. coli.

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(3) Limitations. Do not use in horses peated every 12 hours as indicated, by intended for human consumption. Fed- intramuscular or intravenous injec- eral law restricts this drug to use by or tion. on the order of a licensed veterinarian. (ii) Indications for use. For reducing [76 FR 17338, Mar. 29, 2011, as amended at 78 excessive smooth muscle contractions, FR 17597, Mar. 22, 2013; 79 FR 16183, Mar. 25, such as occur in colic spasms. 2014] (iii) Limitations. Do not use in horses intended for human consumption. Fed- § 522.62 Aminopentamide. eral law restricts this drug to use by or (a) Specifications. Each milliliter of on the order of a licensed veterinarian. 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) —(1) mg; For animals weighing 21 to 50 lbs: Conditions of use in horses Administer 7 mg by 0.3 mg; For animals weighing 51 to 100 Amount. 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 times the suggested dosage. Following (2) Indications for use in horses. For parenteral use, dosage may be contin- treatment of tendinitis of the super- ued by oral administration of tablets. ficial digital flexor tendon (SDFT) in (2) Indications for use. For the treat- horses where there is sonographic evi- ment of vomiting and/or diarrhea, nau- dence of fiber tearing. sea, acute abdominal visceral spasm, (3) Limitations. Do not use in horses pylorospasm, or hypertrophic gastritis. 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 16183, Mar. 25, 2014] [79 FR 16183, Mar. 25, 2014] § 522.88 Amoxicillin. § 522.82 Aminopropazine. (a) Specifications—(1) Each vial con- (a) Specifications. Each milliliter of tains 3 grams (g) of amoxicillin tri- solution contains aminopropazine fu- hydrate. Each milliliter of constituted marate equivalent to 25 milligrams suspension contains 100 or 250 milli- (mg) aminopropazine base. grams (mg) amoxicillin trihydrate for (b) Sponsor. See No. 000061 in use as in paragraph (d)(1) of this sec- § 510.600(c) of this chapter. tion. (c) Conditions of use—(1) Dogs and (2) Each vial contains 25 g of cats—(i) Amount. 1 to 2 mg per pound of amoxicillin trihydrate. Each milliliter body weight, repeated every 12 hours as of constituted suspension contains 250 indicated, by intramuscular or intra- mg amoxicillin trihydrate for use as in venous injection. paragraph (d)(2) of this section. (ii) Indications for use. For reducing (b) Sponsor. See No. 054771 in excessive smooth muscle contractions, § 510.600(c) of this chapter. such as occur in urethral spasms asso- (c) Related tolerance. See § 556.38 of ciated with urolithiasis. this chapter. (iii) Limitations. Federal law restricts (d) Conditions of use—(1) Dogs and this drug to use by or on the order of a cats—(i) Amount. Administer 5 mg per licensed veterinarian. pound of body weight daily for up to 5 (2) Horses—(i) Amount. Administer days by intramuscular or subcutaneous 0.25 mg per pound of body weight, re- injection.

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(ii) Indications for use—(A) Dogs. For law restricts this drug to use by or on treatment of infections caused by sus- the order of a licensed veterinarian. ceptible strains of organisms as fol- [79 FR 16183, Mar. 25, 2014] lows: Respiratory infections (tonsillitis, tracheobronchitis) due to Staphy- § 522.90 Ampicillin injectable dosage lococcus aureus, Streptococcus spp., Esch- forms. erichia coli, and Proteus mirabilis; genitourinary infections (cystitis) due to S. [79 FR 16183, Mar. 25, 2014] aureus, Streptococcus spp., E. coli, and P. 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 de- Streptococcus spp., E. coli, P. mirabilis, scribed in paragraph (a)(2) as in para- and Corynebacterium spp.; gastro- graphs (d)(3)(i)(B), (d)(3)(ii)(B), and intestinal infections due to E. coli, Pro- (d)(3)(iii) of this section. teus spp., Staphylococcus spp., and Strep- (c) Related tolerances. See § 556.40 of tococcus spp.; skin and soft tissue infec- this chapter. tions (abscesses, lacerations, and (d) Conditions of use—(1) Cattle—(i) wounds) due to S. aureus, Staphy- Amount. For enteritis: 3 mg per pound lococcus spp., Streptococcus spp., E. coli, of body weight, intramuscularly, once and Pasteurella multocida. or twice daily, for up to 3 days. For (iii) Limitations. Federal law restricts pneumonia: 3 mg per pound of body this drug to use by or on the order of a weight, intramuscularly, twice daily, licensed veterinarian. for up to 3 days. (2) Cattle—(i) Amount. Administer 3 to (ii) Indications for use. For treatment 5 mg per pound of body weight daily for of bacterial enteritis in calves caused up to 5 days by intramuscular or sub- by Escherichia coli and bacterial pneu- cutaneous injection. monia caused by Pasteurella spp. sus- (ii) Indications for use. For treatment ceptible to ampicillin. of diseases due to amoxicillin-suscep- (iii) Limitations. Treated animals tible organisms as follows: Respiratory must not be slaughtered for food use tract infections (shipping fever, pneu- during treatment or for 9 days after monia) due to P. multocida, P. the last treatment. Federal law re- hemolytica, Haemophilus spp., Staphy- stricts this drug to use by or on the lococcus spp., and Streptococcus spp. and order of a licensed veterinarian. acute necrotic pododermatitis (foot (2) Swine—(i) Amount. 3 mg per pound rot) due to Fusobacterium necrophorum. of body weight by intramuscular injec- (iii) Limitations. Treated animals tion, once or twice daily, for up to 3 must not be slaughtered for food dur- days. ing treatment and for 25 days after the (ii) Indications for use. Treatment of last treatment. Milk from treated cows bacterial enteritis (colibacillosis) must not be used for human consump- caused by E. coli and bacterial pneu- tion during treatment or for 96 hours (8 monia caused by Pasteurella spp. sus- milkings) after last treatment. Federal ceptible to ampicillin.

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(iii) Limitations. Treated animals (b) Sponsors. See Nos. 000010 and must not be slaughtered for food use 010515 in § 510.600(c) of this chapter. during treatment or for 15 days after (c) Related tolerances. See § 556.40 of the last treatment. Federal law re- this chapter. stricts this drug to use by or on the (d) Conditions of use—(1) Dogs and order of a licensed veterinarian. cats—(i) Amount. 3 mg/pound (lb) of (3) Dogs—(i) Amount—(A) 3 to 6 mg body weight twice daily by subcuta- per pound of body weight by neous or intramuscular injection. intramuscular injection, once or twice (ii) Indications for use. For treatment daily. Usual treatment is 3 to 5 days. of strains of organisms susceptible to (B) 3 to 5 mg of ampicillin per pound ampicillin and associated with res- of body weight, once a day for up to 4 piratory tract infections, urinary tract days. infections, gastrointestinal infections, (ii) Indications for use—(A) Treatment skin infections, soft tissue infections, of respiratory tract infections due to E. and postsurgical infections. coli, Pseudomonas spp., Proteus spp., (iii) Limitations. Federal law restricts Staphylococcus spp., and Streptococcus this drug to use by or on the order of a spp.; tonsillitis due to E. coli, licensed veterinarian. Pseudomonas spp., Streptococcus spp., (2) Cattle—(i) Amount. 2 to 5 mg/lb of and Staphylococcus spp.; generalized in- body weight once daily by fections (septicemia) associated with intramuscular injection. abscesses, lacerations, and wounds due (ii) Indications for use. For treatment 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 during treatment and for 144 hours (6 (4) Cats—(i) Amount. 5 to 10 mg per days) after the last treatment. Federal pound of body weight by intramuscular law restricts this drug to use by or on or subcutaneous injection, once or the order of a licensed veterinarian. twice daily. Usual treatment is 3 to 5 days. [57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept. (ii) Indications for use. Treatment of 15, 1992; 58 FR 18304, Apr. 8, 1993; 63 FR 41420, generalized infections (septicemia) as- 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., § 522.90c Ampicillin sodium. Streptococcus spp., and Pasteurella spp. (iii) Limitations. Federal law restricts (a) Specifications. Each milliliter of this drug to use by or on the order of a aqueous solution constituted from am- licensed veterinarian. picillin sodium powder contains 300 milligrams (mg) ampicillin equiva- [79 FR 16183, Mar. 25, 2014] lents. (b) Sponsors. See Nos. 010515 and § 522.90b Ampicillin trihydrate powder 054771 in § 510.600(c) of this chapter. for injection. (c) Conditions of use in horses—(1) (a) Specifications. Each milliliter of Amount: 3 mg per pound of body weight aqueous suspension constituted from twice daily by intravenous or ampicillin trihydrate powder contains intramuscular injection. 50, 100, or 250 milligrams (mg) ampi- (2) Indications for use. For the treat- cillin equivalents. ment of respiratory tract infections

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(pneumonia and strangles) due to § 522.150 Azaperone. Staphylococcus spp., Streptococcus spp. (a) Specifications. Each milliliter of (including S. equi), Escherichia coli, and solution contains 40 milligrams (mg) , and skin and soft tis- Proteus mirabilis azaperone. sue infections (abscesses and wounds) (b) Sponsor. See No. 000986 in due to Staphylococcus spp., Streptococcus § 510.600(c) of this chapter. spp., E. coli, and P. mirabilis, when (c) Conditions of use—(1) Indications caused by susceptible organisms. for use. For control of aggressiveness (3) Limitations. Do not use in horses when mixing or regrouping weanling or intended for human consumption. Fed- feeder pigs weighing up to 80 pounds. eral law restricts this drug to use by or (2) Dosage. 2.2 mg per kilogram (1 mg on the order of a licensed veterinarian. per pound) by deep intramuscular in- [72 FR 45158, Aug. 13, 2007, as amended at 79 jection. FR 16184, Mar. 25, 2014] (3) Limitations. Federal law restricts this drug to use by or on the order of a § 522.144 Arsenamide. licensed veterinarian. (a) Specifications. Each milliliter of [74 FR 65689, Dec. 11, 2009, as amended at 77 solution contains 10.0 milligrams FR 46613, Aug. 6, 2012] arsenamide sodium. (b) Sponsor. See No. 050604 in § 522.161 Betamethasone. § 510.600(c) of this chapter. (a) Specifications. Each milliliter of (c) Conditions of use in dogs—(1) suspension contains: Amount. Administer 0.1 milliliter (mL) (1) Betamethasone acetate equivalent 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: [79 FR 16184, Mar. 25, 2014] (1) No. 000061 for product described in paragraph (a)(1) of this section for use § 522.147 Atipamezole. as in paragraphs (c)(1), (c)(2)(i), (a) Specifications. Each milliliter of (c)(2)(ii)(A), and (c)(2)(iii) of this sec- solution contains 5.0 milligrams tion. 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 20 pounds of body weight, depending on (2) Indications for use. For reversal of the severity of the condition. Fre- the sedative and analgesic effects of quency of dosage depends on recurrence dexmedetomidine hydrochloride or of pruritic symptoms. Dosage may be medetomidine hydrochloride. repeated every 3 weeks or when symp- (3) Limitations. Federal law restricts toms recur, not to exceed a total of this drug to use by or on the order of a four injections. licensed veterinarian. (ii) Indications for use. As an aid in [61 FR 48830, Sept. 17, 1996, as amended at 64 the control of pruritus associated with FR 71640, Dec. 22, 1999; 72 FR 264, Jan. 4, 2007] dermatoses.

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(iii) Limitations. Federal law restricts (iii) Not for use in horses intended for this drug to use by or on the order of a food. licensed veterinarian. (3) Clinical and experimental data. It (2) Horses—(i) Amount. Administer 2.5 has been demonstrated that to 5 mL by intra-articular injection. corticosteroids administered orally or (ii) Indications for use—(A) For the parenterally to animals may induce treatment of various inflammatory the first stage of parturition when ad- joint conditions; for example, acute ministered during the last trimester of and traumatic lameness involving the pregnancy and may precipitate pre- carpel and fetlock joints. mature parturition followed by (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 [40 FR 13858, Mar. 27, 1975, as amended at 41 on the order of a licensed veterinarian. FR 27316, July 2, 1976; 52 FR 7832, Mar. 13, 1987] [79 FR 16184, Mar. 25, 2014] § 522.204 Boldenone. § 522.163 Betamethasone dipropionate and betamethasone sodium phos- (a) Specifications. Each milliliter of phate aqueous suspension. solution contains 25 or 50 milligrams (mg) boldenone undecylenate. (a) Specifications. Betamethasone (b) Sponsor. See No. 054771 in dipropionate and betamethasone so- § 510.600(c) of this chapter. dium phosphate aqueous suspension is (c) Conditions of use in horses—(1) a sterile aqueous suspension. Each mil- Amount. 0.5 mg per pound body weight liliter of the suspension contains the by intramuscular injection. Treatment equivalent of 5 milligrams of may be repeated at 3-week intervals. betamethasone as betamethasone (2) Indications for use. As an aid for dipropionate and 2 milligrams of treating debilitated horses when an im- betamethasone as betamethasone so- provement in weight, hair coat, or gen- dium phosphate. eral physical condition is desired. (b) Sponsor. See No. 000061 in (3) Limitations. Do not administer to § 510.600(c) of this chapter. horses intended for human consump- (c) Conditions of use—(1) Dogs. (i) It is tion. Federal law restricts this drug to used as an aid in the control of pru- use by or on the order of a licensed vet- ritus associated with dermatoses. erinarian. (ii) It is administered by [70 FR 70998, Nov. 25, 2005, as amended at 79 intramuscular injection at a dosage of FR 16184, Mar. 25, 2014] 0.25 to 0.5 milliliter per 20 pounds of body weight, depending on the severity § 522.234 Butamisole. of the condition. Frequency of dosage (a) Specifications. Each milliliter of depends on recurrence of pruritic solution contains 11 milligrams (mg) symptoms. Dosage may be repeated butamisole hydrochloride. every 3 weeks or when symptoms recur, (b) Sponsors. See Nos. 000859 and not to exceed a total of 4 injections. 054771 in § 510.600(c) of this chapter. (2) Horses. (i) It is used as an aid in (c) Conditions of use in dogs—(1) the control of inflammation associated Amount. Administer 0.1 mg per pound with various arthropathies. of body weight by subcutaneous injec- (ii) It is administered aseptically by tion. In problem cases, retreatment for intraarticular injection at a dosage of whipworms may be necessary in ap- 2.5 to 5 milliliters per joint, depending proximately 3 months. For hookworms, on the severity of the condition and a second injection should be given 21 the joint size. Dosage may be repeated days after the initial treatment. upon recurrence of clinical signs. Injec- (2) Indications for use. For the treat- tion into the joint cavity should be ment of infections with whipworms preceded by withdrawal of synovial (Trichuris vulpis), and the hookworm fluid. (Ancylostoma caninum).

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(3) Limitations. Federal law restricts (3) Horses—(i) Amount. Administer this drug to use by or on the order of a 0.05 mg per pound of body weight by in- licensed veterinarian. travenous injection. Dose may be repeated within 3 to 4 hours. Treatment [79 FR 16184, Mar. 25, 2014] should not exceed 48 hours. § 522.246 Butorphanol. (ii) Indications for use. For the relief of pain associated with colic and (a) Specifications. Each milliliter of postpartum pain in adult horses and solution contains butorphanol (as yearlings. butorphanol tartrate) in the following (iii) Limitations. Do not use in horses amounts: intended for human consumption. (1) 0.5 milligrams (mg); (2) 2 mg; or [72 FR 27957, May 18, 2007, as amended at 73 (3) 10 mg FR 31358, June 2, 2008; 74 FR 61516, Nov. 25, 2009; 75 FR 22524, Apr. 29, 2010; 77 FR 60302, (b) Sponsors. See sponsors in Oct. 3, 2012; 78 FR 17597, Mar. 22, 2013; 79 FR § 510.600(c) of this chapter as follows: 16184, Mar. 25, 2014] (1) No. 054771 for use of the product described in paragraph (a)(1) as in para- § 522.275 N-Butylscopolammonium. graph (d)(1) of this section; for use of (a) Specifications. Each milliliter of the product described in paragraph solution contains 20 milligrams (mg) (a)(2) as in paragraph (d)(2) of this sec- N-butylscopolammonium bromide. tion; and for use of the product de- (b) Sponsor. See No. 000010 in scribed in paragraph (a)(3) as in para- § 510.600(c) of this chapter. graph (d)(3) of this section. (c) Conditions of use in horses—(1) (2) No. 000859 for use of the product Amount. 0.3 mg per kilogram of body described in paragraph (a)(2) as in para- weight (0.14 mg per pound) slowly in- graph (d)(2) of this section. travenously. (3) Nos. 000061, 000859, and 061690 for (2) Indications for use. For the control use of the product described in para- of abdominal pain (colic) associated graph (a)(3) as in paragraph (d)(3) of with spasmodic colic, flatulent colic, this section. and simple impactions. (c) Special considerations. Federal law (3) Limitations. Federal law restricts restricts this drug to use by or on the this drug to use by or on the order of a order of a licensed veterinarian. licensed veterinarian. (d) Conditions of use—(1) Dogs—(i) Amount. Administer 0.025 mg per pound [69 FR 35512, June 25, 2004] of body weight by subcutaneous injection at intervals of 6 to 12 hours, as re- § 522.300 Carfentanil. quired. If necessary, increase dose to a (a) Specifications. Each milliliter of maximum of 0.05 mg per pound of body solution contains 3 milligrams (mg) weight. Treatment should not nor- carfentanil citrate. mally be required for longer than 7 (b) Sponsor. See No. 053923 in days. § 510.600(c) of this chapter. (ii) Indications for use. For the relief (c) Conditions of use—(1) Amount. Ad- of chronic nonproductive cough associ- minister 5 to 20 micrograms per kilo- ated with tracheo-bronchitis, tra- gram (0.005 to 0.020 mg per kilogram) of cheitis, tonsillitis, laryngitis, and body weight into large muscle of the pharyngitis associated with inflam- neck, shoulder, back, or hindquarter. matory conditions of the upper res- (2) Indications for use. For immo- piratory tract. bilizing free ranging and confined (2) Cats—(i) Amount. Administer 0.2 members of the family Cervidae (deer, mg per pound of body weight by sub- elk, and moose). cutaneous injection. Dose may be re- (3) Limitations. Do not use in domes- peated up to 4 times per day. Do not tic animals intended for food. Do not treat for more than 2 days. use 30 days before or during hunting (ii) Indications for use. For the relief season. Federal law restricts this drug of pain in cats caused by major or to use by or on the order of a licensed minor trauma, or pain associated with veterinarian. The licensed veterinarian surgical procedures. shall be a veterinarian engaged in zoo

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and exotic animal practice, wildlife abscesses) in cats caused by susceptible management programs, or research. strains of Pasteurella multocida. [79 FR 16185, Mar. 25, 2014] [73 FR 29685, May 22, 2008, as amended at 79 FR 16185, Mar. 25, 2014] § 522.304 Carprofen. (a) Specifications. Each milliliter of § 522.313 Ceftiofur injectable dosage solution contains 50 milligrams (mg) forms. carprofen. (b) Sponsor. See No. 054771 in § 522.313a Ceftiofur crystalline free acid. § 510.600(c) of this chapter. (c) [Reserved] (a) Specifications. The product is a (d) Conditions of use in dogs—(1) suspension of ceftiofur crystalline free Amount. 2 mg/lb (4.4 mg/kg) body acid. weight once daily or 1 mg/lb (2.2 mg/kg) (1) Each milliliter (mL) contains 100 twice daily, by subcutaneous injection. milligrams (mg) ceftiofur equivalents. For the control of postoperative pain, (2) Each mL contains 200 mg ceftiofur administer approximately 2 hours be- equivalents. fore the procedure. (b) Sponsor. See No. 054771 in (2) Conditions of use. For the relief of § 510.600(c) of this chapter. pain and inflammation associated with (c) Related tolerances. See § 556.113 of osteoarthritis and for the control of this chapter. postoperative pain associated with soft (d) Special considerations. Federal law tissue and orthopedic surgeries. restricts this drug to use by or on the (3) Limitations. Federal law restricts order of a licensed veterinarian. this drug to use by or on the order of a (e) Conditions of use—(1) Swine. The licensed veterinarian. formulation described in paragraph [68 FR 26205, May 15, 2003, as amended at 68 (a)(1) of this section is used as follows: FR 34796, June 11, 2003; 68 FR 49351, Aug. 18, (i) Amount. 5.0 mg CE per kilogram 2003. Redesignated at 73 FR 29685, May 22, (kg) of body weight by intramuscular 2008, as amended at 79 FR 16185, Mar. 25, 2014] injection in the postauricular region of § 522.311 Cefovecin. the neck. (ii) Indications for use. For the treat- (a) Specifications. Each milliliter of ment of swine respiratory disease constituted solution contains 80 milli- (SRD) associated with Actinobacillus grams (mg) cefovecin as the sodium pleuropneumoniae, Pasteurella multocida, salt. Haemophilus parasuis, and Streptococcus (b) Sponsor. See No. 054771 in suis. For the control of SRD associated § 510.600(c) of this chapter. with A. pleuropneumoniae, P. multocida, (c) Special considerations. Federal law restricts this drug to use by or on the H. parasuis, and S. suis in groups of pigs order of a licensed veterinarian. where SRD has been diagnosed. (d) Conditions of use—(1) Dogs—(i) (iii) Limitations. Following label use Amount. Administer 3.6 mg/pound (lb) (8 as a single treatment, a 14-day pre- mg/kilograms (kg)) body weight as a slaughter withdrawal period is re- single subcutaneous injection. A sec- quired. ond subcutaneous injection of 3.6 mg/lb (2) Cattle. The formulation described (8 mg/kg) may be administered if rein paragraph (a)(2) of this section is sponse to therapy is not complete. used as follows: (ii) Indications for use. For the treat- (i) Amount. For subcutaneous (SC) in- ment of skin infections (secondary su- jection in the posterior aspect of the perficial pyoderma, abscesses, and ear where it attaches to the head (base wounds) in dogs caused by susceptible of the ear) in lactating dairy cattle. strains of Staphylococcus intermedius For SC injection in the middle third of and Streptococcus canis (Group G). the posterior aspect of the ear or in the (2) Cats—(i) Amount. Administer 3.6 base of the ear in beef and non-lac- mg/lb (8 mg/kg) body weight as a sin- tating dairy cattle. gle, one-time subcutaneous injection. (A) Single-dose regimen: 6.6 mg (ii) Indications for use. For the treat- ceftiofur equivalents per kg of body ment of skin infections (wounds and weight as a single injection.

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(B) Two-dose regimen: 6.6 mg tains 50 milligrams (mg) ceftiofur ceftiofur equivalents per kg of body equivalents. weight given as two injections in the (b) Sponsor. See No. 054771 in base of the ear approximately 72 hours § 510.600(c) of this chapter. apart. (c) Related tolerances. See § 556.113 of (ii) Indications for use—(A) Single- this chapter. dose regimen: For the treatment of bo- (d) Special considerations. Federal law vine respiratory disease (BRD, shipping restricts this drug to use by or on the fever, pneumonia) associated with order of a licensed veterinarian. Fed- Mannheimia haemolytica, Pasteurella eral law prohibits extra-label use of multocida, and Histophilus somni in beef, this drug in cattle and swine for dis- non-lactating dairy, and lactating ease prevention purposes; at unap- dairy cattle. For the control of res- proved doses, frequencies, durations, or piratory disease in beef and non-lac- routes of administration; and in unap- tating dairy cattle which are at high proved major food-producing species/ risk of developing BRD associated with production classes. M. haemolytica, P. multocida, and H. (e) Conditions of use. (1) Swine—(i) somni. For the treatment of bovine foot Amount. 3 to 5 mg per kilogram (/kg) of rot (interdigital necrobacillosis) asso- body weight by intramuscular injec- ciated with Fusobacterium necrophorum tion. Treatment should be repeated at and Porphyromonas levii in beef, non- 24-hour intervals for a total of 3 con- lactating dairy, and lactating dairy secutive days. cattle. (ii) Indications for use. For treatment (B) Two-dose regimen: For the treat- and control of swine bacterial res- ment of acute metritis (0-to 10-days piratory disease (swine bacterial pneu- postpartum) associated with bacterial monia) associated with Actinobacillus organisms susceptible to ceftiofur in pleuropneumoniae, Pasteurella multocida, lactating dairy cattle. Salmonella Choleraesuis, and Strepto- (iii) Limitations. Following label use coccus suis. as either a single-dose or 2-dose regimen, a 13-day pre-slaughter withdrawal (iii) Limitations. Treated swine must period is required after the last treat- not be slaughtered for 4 days following ment. A withdrawal period has not the last treatment. been established in preruminating (2) Cattle—(i) Amount. Administer by calves. Do not use in calves to be proc- subcutaneous or intramuscular injec- essed for veal. tion as follows: (3) Horses. The formulation described (A) For bovine respiratory disease in paragraph (a)(2) of this section is and acute bovine interdigital used as follows: necrobacillosis: 1.1 to 2.2 mg/kg of body (i) Amount. Two intramuscular injec- weight at 24-hour intervals for 3 to 5 tions, 4 days apart, at a dose of 3.0 mg/ consecutive days. lb (6.6 mg/kg) body weight. (B) For bovine respiratory disease: 2.2 (ii) Indications for use. For the treat- mg/kg of body weight administered ment of lower respiratory tract infec- twice at a 48 hour interval. tions in horses caused by susceptible (C) For acute metritis: 2.2 mg/kg of strains of Streptococcus equi ssp. body weight at 24-hour intervals for 5 zooepidemicus. consecutive days. (iii) Limitations. Do not use in horses (ii) Indications for use. For treatment intended for human consumption. of bovine respiratory disease (BRD, shipping fever, pneumonia) associated [68 FR 60296, Oct. 22, 2003, as amended at 69 FR 43892, July 23, 2004. Redesignated and with Mannheimia haemolytica, P. amended at 71 FR 39546, July 13, 2006; 73 FR multocida, and Histophilus somni; acute 58872, Oct. 8, 2008; 75 FR 4692, Jan. 29, 2010; 75 bovine interdigital necrobacillosis FR 62468, Oct. 12, 2010; 77 FR 26162, May 3, (foot rot, pododermatitis) associated 2012; 79 FR 16185, Mar. 25, 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.

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(iii) Limitations. Treated cattle must (3) Sheep—(i) Amount. 0.5 to 1.0 mg/lb not be slaughtered for 4 days following body weight by intramuscular injec- the last treatment. A withdrawal pe- tion for 3 days. Additional treatments riod has not been established in may be given on days 4 and 5 for ani- preruminating calves. Do not use in mals which do not show satisfactory calves to be processed for veal. response. [61 FR 29479, June 11, 1996, as amended at 63 (ii) Indications for use. For treatment FR 53578, Oct. 6, 1998; 67 FR 45901, July 11, of sheep respiratory disease (sheep 2002; 69 FR 47362, Aug. 5, 2004. Redesignated pneumonia) associated with and amended at 71 FR 39544, July 13, 2006; 73 Mannheimia haemolytica and Pasteurella FR 45612, Aug. 6, 2008; 76 FR 17338, Mar. 29, multocida. 2011; 78 FR 66264, Nov. 5, 2013] (4) Goats—(i) Amount. 0.5 to 1.0 mg/lb § 522.313c Ceftiofur sodium. body weight by intramuscular injection for 3 days. Additional treatments (a) Specifications. Each milliliter of may be given on days 4 and 5 for ani- aqueous solution constituted from mals which do not show satisfactory ceftiofur sodium powder contains 50 response. milligrams (mg) ceftiofur equivalents. (ii) Indications for use. For treatment (b) Sponsors. See Nos. 000409, 054771, and 068330 in § 510.600(c) of this chapter. of caprine respiratory disease (goat pneumonia) associated with (c) Related tolerances. See § 556.113 of this chapter. Mannheimia haemolytica and Pasteurella multocida. (d) Special considerations. Federal law restricts this drug to use by or on the (5) Chickens—(i) Amount. 0.08 to 0.20 order of a licensed veterinarian. mg as a single subcutaneous injection (e) Conditions of use—(1) Swine—(i) in the neck. Amount. 3 to 5 mg per kilogram (/kg) (ii) Indications for use. For control of body weight by intramuscular injec- early mortality associated with Esch- tion for 3 consecutive days. erichia coli organisms susceptible to (ii) Indications for use. For treatment ceftiofur in day-old chicks. and control of swine bacterial res- (6) Turkeys—(i) Amount. 0.17 to 0.5 mg piratory disease (swine bacterial pneu- as a single subcutaneous injection in monia) associated with Actinobacillus the neck. pleuropneumoniae, Pasteurella multocida, (ii) Indications for use. For control of Salmonella choleraesuis, and Strepto- early mortality associated with E. coli coccus suis. organisms susceptible to ceftiofur in (iii) Limitations. Treated pigs must day-old poults. not be slaughtered for 4 days following (7) Horses—(i) Amount. 2.2 to 4.4 mg/kg the last treatment. (1.0 to 2.0 mg/lb) body weight by (2) Cattle—(i) Amount. 0.5 to 1.0 mg/lb intramuscular injection. Treatment body weight by intramuscular or sub- should be repeated every 24 hours, con- cutaneous injection for 3 days. Addi- tinued for 48 hours after clinical signs tional treatments may be given on have disappeared, and should not ex- days 4 and 5 for animals which do not ceed 10 days. A maximum of 10 mL show satisfactory response. should be administered per injection (ii) Indications for use. For treatment site. of bovine respiratory disease (shipping (ii) Indications for use. For treatment fever, pneumonia) associated with of respiratory infections in horses asso- Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. Also, ciated with Streptococcus zooepidemicus. for the treatment of acute bovine (iii) Limitations. Do not use in horses interdigital necrobacillosis (foot rot, intended for human consumption. pododermatitis) associated with (8) Dogs—(i) Amount. 1.0 mg/lb (2.2 mg/ Fusobacterium necrophorum and kg) body weight by subcutaneous injec- Bacteroides melaninogenicus. tion. Treatment should be repeated at (iii) Limitations. Treated cattle must 24-hour intervals for 5 to 14 days. not be slaughtered for 4 days following the last treatment.

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(ii) Indications for use. For treatment litis caused by organisms susceptible of canine urinary tract infections asso- to chloramphenicol. ciated with E. coli and Proteus mirabilis. (3) Limitations. Federal law restricts [53 FR 5369, Feb. 24, 1988, as amended at 55 this drug to use by or on the order of a FR 13768, Apr. 12, 1990; 56 FR 12119, Mar. 22, licensed veterinarian. Federal law pro- 1991; 57 FR 41862, Sept. 14, 1992; 59 FR 41666, hibits the extralabel use of this drug in Aug. 15, 1994; 59 FR 54518, Nov. 1, 1994; 60 FR food-producing animals. 51719, Oct. 3, 1995; 61 FR 35130, July 5, 1996; 61 FR 66583, Dec. 18, 1996; 66 FR 21283, Apr. 30, [57 FR 37331, Aug. 18, 1992, as amended at 65 2001; 66 FR 32540, June 15, 2001; 69 FR 47362, FR 45877, July 26, 2000; 78 FR 17597, Mar. 22, Aug. 5, 2004. Redesignated and amended at 71 2013; 79 FR 16185, Mar. 25, 2014] FR 39544, July 13, 2006; 74 FR 34236, July 15, 2009; 77 FR 29218, May 17, 2012; 79 FR 16185, § 522.460 Cloprostenol. Mar. 25, 2014] (a) Specifications. Each milliliter of § 522.380 Chloral hydrate, pento- solution contains cloprostenol sodium barbital, and magnesium sulfate. equivalent to: (a) Specifications. Each milliliter of (1) 125 micrograms (μg) of solution contains 42.5 milligrams (mg) cloprostenol; or of chloral hydrate, 8.86 mg of pento- (2) 250 μg of cloprostenol. barbital, and 21.2 mg of magnesium sul- (b) Sponsors. See sponsors in fate. § 510.600(c) of this chapter. (b) Sponsor. See No. 054771 in (1) No. 000061 for use of product de- § 510.600(c) of this chapter. scribed in paragraph (a)(1) of this sec- (c) Conditions of use—(1) Amount. For tion as in paragraphs (c)(1)(i) and (c)(2) general anesthesia: Administer 20 to 50 of this section. milliliters per 100 pounds of body (2) Nos. 000061 and 068504 for use of weight by intravenous injection until product described in paragraph (a)(2) as the desired effect is produced. Cattle in paragraphs (c)(1)(ii), (c)(1)(iii), and usually require a lower dosage on the (c)(2) of this section. basis of body weight. As a sedative-relaxant: Administer at a level of one- (c) Conditions of use in cattle—(1) fourth to one-half of the anesthetic Amount and indications for use—(i) Ad- μ dosage level. minister 375 g by intramuscular injec- (2) Indications for use. For general an- tion to induce abortion in pregnant esthesia and as a sedative-relaxant in feedlot heifers from 1 week after mat- cattle and horses. ing until 4 1/2 months of gestation. (3) Limitations. Federal law restricts (ii) Administer 500 μg by this drug to use by or on the order of a intramuscular injection for termi- licensed veterinarian. nating unwanted pregnancies from mismatings from 1 week after mating [79 FR 16185, Mar. 25, 2014] until 5 months after conception; for § 522.390 Chloramphenicol. treating unobserved (nondetected) estrus, mummified fetus, and luteal (a) Specifications. Each milliliter of solution contains 100 milligrams of cysts; and for the treatment of chloramphenicol. pyometra. (b) Sponsor. See Nos. 000859 and 054771 (iii) Administer 500 μg by in § 510.600(c) of this chapter. intramuscular injection as a single in- (c) Conditions of use. Dogs—(1) jection regimen or double injection Amount. 5 to 15 milligrams per pound of regimen with a second injection 11 days body weight, intramuscularly or intra- after the first, for scheduling estrus venously, every 6 hours. In severe in- and ovulation to control the time at fections, use 4 to 6 hour treatment in- which cycling cows or heifers can be tervals the first day. If no response is bred. obtained in 3 to 5 days, discontinue use (2) Limitations. Federal law restricts and reevaluate diagnosis. this drug to use by or on the order of a (2) Indications for use. Treatment of licensed veterinarian. infections of the respiratory tract, the urinary tract, and enteritis and tonsil- [79 FR 16185, Mar. 25, 2014]

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§ 522.468 Colistimethate sodium pow- is a general deficiency of corticotropin der for injection. (ACTH). (a) Specifications. Each vial contains (iii) Limitations. Federal law restricts colistimethate sodium equivalent to 10 this drug to use by or on the order of a grams colistin activity and mannitol licensed veterinarian. to be reconstituted with 62.5 milliliters (3) Cattle—(i) Amount. Administer 200 sterile saline or sterile water for injec- to 600 units by intramuscular or sub- tion. The resulting solution contains cutaneous injection as an initial dose, colistimethate sodium equivalent to followed by a dose daily or every other 133 milligrams per milliliter colistin day of 200 to 300 units. activity. (ii) Indications for use. As a thera- (b) Sponsor. See 054771 in § 510.600(c) of peutic agent for primary bovine keto- this chapter. sis; and for stimulation of the adrenal (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 colistin. § 522.518 Cupric glycinate injection. (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 [63 FR 13123, Mar. 18, 1998, as amended at 79 and under; 400 milligrams (2 mL) for FR 16185, Mar. 25, 2014] calves over 300 pounds and adult cattle. (2) Indications for use. For beef calves § 522.480 Corticotropin. and beef cattle for the prevention of (a) Specifications. Each milliliter of copper deficiency, or when labeled for aqueous solution contains 40 or 80 veterinary prescription use, for the U.S.P. (I.U.) units of repository prevention and/or treatment of copper corticotropin. deficiency alone or in association with (b) Sponsor. See sponsors in molybdenum toxicity. § 510.600(c) of this chapter. (3) Limitations. For subcutaneous use (1) No. 061623 for use as in paragraphs only; repeat dose in 3 months in young (c)(1) and (2) of this section. calves, in 6 months in cattle; dis- (2) No. 026637 for use as in paragraph continue use 30 days before treated ani- (c)(2) and (3) of this section. mals are slaughtered for food use; Fed- (c) Conditions of use—(1) Dogs—(i) eral law restricts this drug to use by or Amount. Administer one unit per pound on the order of a licensed veterinarian. of body weight by intramuscular injection. [46 FR 20159, Apr. 3, 1981, as amended at 52 (ii) Indications for use. As a diagnostic FR 7832, Mar. 13, 1987; 62 FR 28630, May 27, aid to test for adrenal dysfunction. 1997] (iii) Limitations. Federal law restricts § 522.522 Danofloxacin. this drug to use by or on the order of a licensed veterinarian. (a) Specifications. Each milliliter of (2) Dogs and cats—(i) Amount. Admin- solution contains 180 milligrams (mg) ister one unit per pound of body weight danofloxacin as the mesylate salt. by intramuscular or subcutaneous in- (b) Sponsor. See No. 054771 in jection, to be repeated as indicated. § 510.600(c) of this chapter. (ii) Indications for use. For stimula- (c) Related tolerances. See § 556.169 of tion of the adrenal cortex where there this chapter.

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(d) Conditions of use in cattle— (1) trous mares with an ovarian follicle be- Amount: Administer by subcutaneous tween 30 and 40 mL in diameter. injection either: (iii) Limitations. Do not use in horses (i) 6 mg per kilogram (mg/kg) of body intended for human consumption. Fed- weight, repeated in 48 hours; or eral law restricts this drug to use by or (ii) 8 mg/kg of body weight, as a sin- on the order of a licensed veterinarian. gle dose. (2) Indications for use. For the treat- [75 FR 81456, Dec. 28, 2010, as amended at 79 ment of bovine respiratory disease FR 18158, Apr. 1, 2014] (BRD) associated with Mannheimia § 522.535 Desoxycorticosterone. haemolytica and Pasteurella multocida. (3) Limitations. Animals intended for (a) Specifications. Each milliliter of human consumption should not be suspension contains 25 milligrams of slaughtered within 4 days from the last desoxycorticosterone pivalate. treatment. Do not use in cattle in- (b) Sponsor. See No. 058198 in tended for dairy production. A with- § 510.600(c) of this chapter. drawal period has not been established (c) Conditions of use—(1) Dogs—(i) for this product in pre-ruminating Amount. Dosage requirements are vari- calves. Do not use in calves to be proc- able and must be individualized on the essed for veal. Federal law restricts basis of the response of the patient to this drug to use by or on the order of a therapy. Initial dose of 1 milligram per licensed veterinarian. Federal law pro- pound (0.45 kilogram) of body weight hibits the extra-label use of this drug every 25 days, intramuscularly. Usual in food-producing animals. dose is 0.75 to 1.0 milligram per pound of body weight every 21 to 30 days. [67 FR 78972, Dec. 27, 2002, as amended at 77 FR 4227, Jan. 27, 2012; 79 FR 16185, Mar. 25, (ii) Indications for use. For use as re- 2014] placement therapy for the mineralocorticoid deficit in dogs with § 522.533 Deslorelin. primary adrenocortical insufficiency. (a) Specifications—(1) Each implant (iii) Limitations. Federal law restricts contains 2.1 milligrams (mg) deslorelin this drug to use by or on the order of a acetate. licensed veterinarian. (2) Each milliliter (mL) of suspension (2) [Reserved] contains 1.8 mg deslorelin acetate. (b) Sponsors. See sponsor numbers in [63 FR 13122, Mar. 18, 1998, as amended at 79 FR 16185, Mar. 25, 2014] § 510.600(c) of this chapter as follows: (1) No. 051311 for use of product de- § 522.536 Detomidine. scribed in paragraph (a)(1) as in paragraph (c)(1) of this section. (a) Specification. Each milliliter of so- (2) No. 051330 for use of product de- lution contains 10 milligrams of scribed in paragraph (a)(2) as in para- detomidine hydrochloride. graph (c)(2) of this section. (b) Sponsor. See No. 052483 in (c) Conditions of use—(1) Horses and § 510.600(c) of this chapter. ponies—(i) Amount. One implant per (c) Conditions of use in horses—(1) mare subcutaneously in the neck. Amount. For sedation, analgesia, or se- (ii) Indications for use. For inducing dation and analgesia: 20 or 40 ovulation within 48 hours in estrous micrograms per kilogram (0.2 or 0.4 mares with an ovarian follicle greater milliliter per 100 kilogram or 220 than 30 mL in diameter. pounds) by body weight, depending on (iii) Limitations. Do not use in horses depth and duration required. For seda- or ponies intended for human consumption, administer by intraveneous (IV) tion. Federal law restricts this drug to or intramuscular (IM) injection; for an- use by or on the order of a licensed vet- algesia, administer by IV injection; for erinarian. both sedation and analgesia, admin- (2) Horses—(i) Amount. Administer 1.8 ister by IV injection. mg (1 mL) by intramuscular injection (2) Indication for use. As a sedative in the neck. and analgesic to facilitate minor sur- (ii) Indications for use. For inducing gical and diagnostic procedures in ma- ovulation within 48 hours in cyclic es- ture horses and yearlings.

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(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 therapy before or after surgery to en- [79 FR 16186, Mar. 25, 2014] hance recovery of poor surgical risks, § 522.540 Dexamethasone solution. and as supportive therapy in nonspecific dermatosis. (a)(1) Specifications. Each milliliter of (iii) Limitations. Federal law restricts solution contains 2 milligrams (mg) this drug to use by or on the order of a dexamethasone. licensed veterinarian. (2) Sponsors. See sponsors in (c)(1) Specifications. Each milliliter of § 510.600(c) of this chapter: solution contains 2.0 mg of dexametha- (i) Nos. 000061, 000859, and 061623 for sone or 4.0 mg of dexamethasone so- use as in paragraph (a)(3) of this sec- dium phosphate (equivalent to 3.0 mg tion. of dexamethasone). (ii) Sponsors. See Nos. 054925 and (2) Sponsor. See Nos. 000402 and 061623 058005 for use as in paragraphs in § 510.600(c) of this chapter. (a)(3)(i)(C), (a)(3)(i)(D), (a)(3)(ii)(A), and (3) Conditions of use—(i) Amount. Ad- (a)(3)(iii) of this section. minister 2.5 to 5.0 mg by intravenous (3) Conditions of use—(i) Amount. The injection. drug is administered intravenously or (ii) Indications for use. For use in intramuscularly and dosage may be re- horses as a rapid adrenal peated if necessary, as follows: glucocorticoid and/or anti-inflam- (A) Dogs. 0.25 to 1 mg. matory agent. (B) Cats. 0.125 to 0.5 mg. (iii) Limitations. Do not use in horses (C) Horses. 2.5 to 5 mg. intended for human consumption. Fed- (D) Cattle. 5 to 20 mg, depending on eral law restricts this drug to use by or the severity of the condition. on the order of a licensed veterinarian. (ii) Indications for use. The drug is in- (d)(1) Specifications. Each milliliter of dicated: solution contains 2.0 mg of dexametha- (A) For the treatment of primary bo- sone or 4.0 mg of dexamethasone so- vine ketosis and as an anti-inflam- dium phosphate (equivalent to 3.0 mg matory agent in cattle and horses; of dexamethasone). (B) As an anti-inflammatory agent in (2) Sponsors. See the following num- dogs and cats. bers in § 510.600(c) of this chapter: (iii) Limitations. Do not use in horses (i) Nos. 000859 and 054771 for intra- intended for human consumption. Fed- venous or intramuscular use of 2.0 mil- eral law restricts this drug to use by or ligrams dexamethasone injection. on the order of a licensed veterinarian. (ii) No. 054771 for intravenous use of (b)(1) Specifications. Each milliliter of 2.0 milligrams dexamethasone injec- solution contains 2.0 mg of dexametha- tion. sone or 4.0 mg of dexamethasone so- (3) Conditions of use—(i) Amount. Ad- dium phosphate (equivalent to 3.0 mg minister by intravenous or dexamethasone). intramuscular injection as follows: (2) Sponsor. See number in § 510.600(c) (A) Dogs: 0.25 to 1 mg. of this chapter as follows: (B) Cats: 0.125 to 0.5 mg. (i) No. 061623 for use of 2.0 milligrams (C) Horses: 2.5 to 5 mg. dexamethasone or 4.0 milligrams dexa- (ii) Indications for use. For use in methasone sodium phosphate injec- dogs, cats, and horses as an anti-in- tions. flammatory agent. (ii) No. 000402 for use of 2.0 milli- (iii) Limitations. Do not use in horses grams dexamethasone or 4.0 milligrams intended for human consumption. Fed- dexamethasone sodium phosphate in- eral law restricts this drug to use by or jections. on the order of a licensed veterinarian. (3) Conditions of use—(i) Amount. Ad- (e)(1) Specifications. Each milliliter of minister 0.25 to 1 mg by intravenous in- solution contains 4.0 mg of dexametha- jection, repeated for 3 to 5 days or until sone sodium phosphate (equivalent to a response is noted. 3.0 mg dexamethasone).

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(2) Sponsor. See No. 000859 in travenous injection or 500 μg/m2 of body § 510.600(c) of this chapter. surface area by intramuscular injec- (3) Conditions of use—(i) Amount. Ad- tion. minister by intravenous injection as (B) For use as a preanesthetic to gen- follows: eral anesthesia, administer 125 μg/m2 of (A) Dogs: 0.25 to 1 mg; may be re- body surface area or 375 μg/m2 of body peated for 3 to 5 days. surface area by intramuscular injec- (B) Horses: 2.5 to 5 mg. tion. (ii) Indications for use. For use in dogs (ii) Limitations. Federal law restricts and horses for glucocorticoid and anti- this drug to use by or on the order of a inflammatory effect. licensed veterinarian. (iii) Limitations. Do not use in horses (2) Cats—(i) Amount. 40 μg/killogram intended for human consumption. Fed- by intramuscular injection. eral law restricts this drug to use by or (ii) Indications for use. For use as a on the order of a licensed veterinarian. sedative and analgesic to facilitate [41 FR 28265, July 9, 1976] clinical examinations, clinical procedures, minor surgical procedures, and EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 522.540, see the List of CFR minor dental procedures; and as a Sections Affected, which appears in the preanesthetic to general anesthesia. Finding Aids section of the printed volume (iii) Limitations. Federal law restricts and at www.fdsys.gov. this drug to use by or on the order of a licensed veterinarian. § 522.542 Dexamethasone suspension. [72 FR 263, Jan. 4, 2007, as amended at 72 FR (a) Specifications. Each milliliter of 19797, Apr. 20, 2007; 72 FR 51365, Sept. 7, 2007; suspension contains 1 milligram (mg) 75 FR 60308, Sept. 30, 2010; 78 FR 25183, Apr. of dexamethasone-21-isonicotinate. 30, 2013; 78 FR 33699, June 5, 2013] (b) Sponsor. No. 000010 in § 510.600(c) of this chapter. § 522.563 Diatrizoate. (c) Conditions of use—(1) Amount. Ad- (a) Specifications. Each milliliter of minister by intramuscular injection as solution contains 34.3 percent dia- follows: Dogs: 0.25 to 1 mg; cats: 0.125 to trizoate meglumine and 35 percent dia- 0.5 mg; horses: 5 to 20 mg. Dosage may trizoate sodium, or 66 percent dia- be repeated. trizoate meglumine and 10 percent dia- (2) Indications for use. For the treat- trizoate sodium. ment of various inflammatory condi- (b) Sponsor. See No. 054771 in tions associated with the musculo- § 510.600(c) of this chapter. skeletal system in dogs, cats, and (c) — horses. Conditions of use in dogs and cats (1) Amount. For excretion urography, (3) Limitations. Do not use in horses administer 0.5 to 1.0 milliliter (mL) per intended for human consumption. Fed- pound of body weight to a maximum of eral law restricts this drug to use by or 30 mL intravenously. For cystography, on the order of a licensed veterinarian. remove urine, administer 5 to 25 mL di- [79 FR 16186, Mar. 25, 2014] rectly into the bladder via catheter. For urethrography, administer 1.0 to 5 § 522.558 Dexmedetomidine. mL via catheter into the urethra to (a) Specifications. Each milliliter of provide desired contrasts delineation. solution contains 0.1 or 0.5 milligrams For angiocardiography (including dexmedetomidine hydrochloride. aortography) rapidly inject 5 to 10 mL (b) Sponsor. See No. 052483 in directly into the heart via catheter or § 510.600(c) of this chapter. intraventricular puncture. For cerebral (c) Conditions of use—(1) Dogs—(i) In- angiography, rapid injection of 3 to 10 dications for use and amount. (A) For mL via carotid artery. For peripheral use as a sedative and analgesic to fa- arteriography and/or venography and cilitate clinical examinations, clinical selective coronary arteriography, rap- procedures, minor surgical procedures, idly inject 3 to 10 mL intravascularly and minor dental procedures, admin- into the vascular bed to be delineated. ister 375 micrograms (μg) per square For lymphography, slowly inject 1.0 to meter (/m2) of body surface area by in- 10 mL directly into the lymph vessel to

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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, [57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept. slowly inject 0.5 to 1.0 mL directly into 15, 1992; 79 FR 16187, Mar. 25, 2014] the disc to be delineated. For sialography, slowly inject 0.5 to 1.0 mL into § 522.690 Dinoprost solution. the duct to be delineated. For delinea- (a) Specifications. Each milliliter tion of fistulous tracts, slowly inject (mL) of solution contains dinoprost quantity necessary to fill the tract. tromethamine equivalent to 5 milli- For delineation of peritoneal hernias, grams (mg) dinoprost. inject 0.5 to 1.0 mL per pound of body (b) Sponsors. See Nos. 054771 and weight directly into the peritoneal cav- 059130 in § 510.600(c) of this chapter. ity. (c) Special considerations. (1) Federal (2) Indications for use. For visualiza- law restricts this drug to use by or on tion in excretion urography, including the order of a licensed veterinarian. renal angiography, uretography, (2) Women of child-bearing age, cystography, and urethrography; asthmatics, and persons with bronchial aortography; angiocardiography, pe- and other respiratory problems should ripheral arteriography, and exercise extreme caution when han- venography; selective coronary arteri- dling this product. Dinoprost ography; cerebral angiography; tromethamine is readily absorbed lymphography; arthrography; discog- through the skin and can cause abor- raphy; and sialography; and as an aid tion and bronchiospasms. Accidental in delineating peritoneal hernias and spillage on the skin should be washed fistulous tracts. off immediately with soap and water. (3) Limitations. Federal law restricts (d) Conditions of use—(1) Horses—(i) this drug to use by or on the order of a Amount. 1 mg per 100 pounds of body licensed veterinarian. weight as a single intramuscular injection. [79 FR 16186, Mar. 25, 2014] (ii) Indications. For its luteolytic ef- § 522.650 Dihydrostreptomycin sulfate fect to control timing of estrus in injection. estrus cycling mares and in clinically anestrous mares that have a corpus (a) Specifications. Each milliliter con- luteum. tains dihydrostreptomycin sulfate (iii) Limitations. Not for use in horses equivalent to 500 milligrams of dihy- intended for food. drostreptomycin. (2) Cattle—(i) Beef cattle and nonlac- (b) Sponsors. See Nos. 054771 and tating dairy heifers—(A) Amount. 25 mg 055529 in § 510.600(c) of this chapter. as an intramuscular injection either (c) Related tolerance. See § 556.200 of once or twice at a 10- to 12-day inter- this chapter. val. (d) Conditions of use— (1) Amount. Ad- (B) Indications. For its luteolytic ef- minister 5 milligrams per pound of fect to control timing of estrus and body weight by deep intramuscular in- ovulation in estrous cycling cattle that jection every 12 hours, for 3 to 5 days or have a corpus luteum. until the urine is free of leptospira for (ii) Beef cattle and nonlactating dairy at least 72 hours as measured by heifers—(A) Amount. 25 mg as a single darkfield microscopic examination. intramuscular injection. (2) Indications for use. Treatment of (B) Indications. For treatment of leptospirosis in dogs and horses due to pyometra (chronic endometritis). Leptospira canicola, L. (iii) Nonlactating cattle—(A) Amount. icterohemorrhagiae, and L. pomona; in 25 mg as a single intramuscular injec- cattle due to L. pomona; and in swine tion during the first 100 days of gesta- due to L. pomona; and L. grippotyphosa. tion. (3) Limitations. Discontinue use 30 (B) Indications. For its abortifacient days before slaughter for food. Not for effect in nonlactating cattle. use in animals producing milk because (iv) Lactating dairy cattle—(A) use of the drug will contaminate the Amount. 25 mg as a single milk. Federal law restricts this drug to intramuscular injection.

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(B) Indications. For treatment of (ii) Indications for use. For treatment unobserved (silent) estrus in lactating and control of gastrointestinal dairy cattle that have a corpus luteum. roundworms, lungworms, eyeworms, (v) Dinoprost solution as provided by grubs, sucking lice, and mange mites. No. 000009 in § 510.600(c) of this chapter To control infections and to protect may be used concurrently with pro- from reinfection with Cooperia gesterone intravaginal inserts as in oncophora and Haemonchus placei for 14 § 529.1940 of this chapter. days, Ostertagia ostertagi for 21 days, (3) Swine—(i) Amount. 10 mg as a sin- and C. punctata, Oesophagostomum gle intramuscular injection. radiatum, and Dictyocaulus viviparus for (ii) Indications. For parturition induc- 28 days after treatment. tion in swine when injected within 3 (iii) Limitations. Administer as a sin- days of normal predicted farrowing. gle subcutaneous or intramuscular injection. Do not slaughter cattle within [67 FR 41824, June 20, 2002, as amended at 79 35 days of treatment. Not for use in fe- FR 16187, Mar. 25, 2014] male dairy cattle 20 months of age or § 522.723 Diprenorphine. older. Do not use in calves to be processed for veal. (a) Specifications. Each milliliter of (2) Swine—(i) Amount. 300 micrograms solution contains 2 milligrams of per kilogram (10 milligrams per 75 diprenorphine hydrochloride. pounds). (b) Sponsors. See No. 053923 in (ii) Indications for use. For treatment § 510.600(c) of this chapter. and control of gastrointestinal (c) Conditions of use—(1) Amount. It is roundworms, lungworms, kidney administered intramuscularly or intra- worms, sucking lice, and mange mites. venously at a suitable dosage level de- (iii) Limitations. Administer as a sin- pending upon the species. gle intramuscular injection. Do not (2) Indications for use. The drug is slaughter swine within 24 days of treat- used for reversing the effects of ment. Consult your veterinarian for as- etorphine hydrochloride injection, vet- sistance in the diagnosis, treatment, erinary, the use of which is provided and control of parasitism. for in § 522.883, in wild and exotic animals. [61 FR 53321, Oct. 11, 1996, as amended at 62 (3) Limitations. For use in wild or ex- FR 44410, Aug. 21, 1997; 62 FR 62242, Nov. 21, otic animals only. Do not use in domes- 1997; 63 FR 68183, Dec. 10, 1998; 64 FR 13509, Mar. 19, 1999; 79 FR 16187, Mar. 25, 2014] tic food-producing animals. Do not use 30 days before, or during, the hunting § 522.775 Doxapram. season in free-ranging wild animals that might be used for food. Federal (a) Specifications. Each milliliter of law restricts this drug to use by or on solution contains 20 milligrams (mg) the order of a licensed veterinarian. doxapram hydrochloride. Distribution is restricted to veterinar- (b) Sponsor. See No. 000010 in ians engaged in zoo and exotic animal § 510.600(c) of this chapter. practice, wildlife management pro- (c) Conditions of use—(1) Amount. For grams, and researchers. intravenous use in dogs and cats at a dose of 21⁄2 to 5 mg per pound (/lb) body [79 FR 16187, Mar. 25, 2014] weight in barbiturate anesthesia, 0.5 mg/lb in inhalation anesthesia; for in- § 522.770 Doramectin. travenous use in horses at 0.25 mg/lb (a) Specifications. Each milliliter of body weight in barbiturate anesthesia, solution contains 10 milligrams of 0.2 mg/lb in inhalation anesthesia, 0.25 doramectin. mg/lb with chloral hydrate with or (b) Sponsor. See No. 054771 in § 510.600 without magnesium sulfate; for sub- (c) of this chapter. cutaneous, sublingual, or umbilical (c) Related tolerances. See § 556.225 of vein administration in neonate puppies this chapter. at a dose rate of 1 to 5 mg; for subcuta- (d) Conditions of use—(1) Cattle—(i) neous or sublingual use in neonate kit- Amount. 200 micrograms per kilogram tens at 1 to 2 mg. Dosage may be re- (10 milligrams per 110 pounds). peated in 15 to 20 minutes if necessary.

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(2) Indications for use. Administer to the rate of 0.02 mg per pound of body dogs, cats, and horses to stimulate res- weight; or piration during and after general anes- (B) 1 mL per 25 to 60 lbs of body thesia; or to speed awakening and re- weight by intravenous injection in con- turn of reflexes after anesthesia. Ad- junction with atropine sulfate adminis- minister to neonate dogs and cats to tered at the rate of 0.02 mg per pound initiate respiration following dystocia of body weight. or caesarean section; or to stimulate (ii) For general anesthesia, admin- respiration following dystocia or cae- ister as follows: sarean section. (A) Administer 1 mL per 40 lbs of (3) Limitations. Federal law restricts body weight by intramuscular injec- this drug to use by or on the order of a tion in conjunction with atropine sul- licensed veterinarian. fate administered at the rate of 0.02 mg per pound of body weight and followed [72 FR 261, Jan. 4, 2007, as amended at 75 FR 10167, Mar. 5, 2010; 77 FR 60302, Oct. 3, 2012] in 10 minutes by an intravenous administration of sodium pentobarbital at § 522.784 Doxylamine. the rate of 3 mg per pound of body (a) Specifications. Each milliliter con- weight; or tains 11.36 milligrams (mg) of (B) Administer 1 mL per 25 to 60 lbs doxylamine succinate. of body weight by intravenous injec- (b) Sponsor. See No. 000061 in tion in conjunction with atropine sul- § 510.600(c) of this chapter. fate administered at the rate of 0.02 mg (c) Conditions of use—(1) Amount—(i) per pound of body weight and followed Horses: Administer 25 mg per hundred within 15 seconds by an intravenous ad- pounds of body weight by ministration of sodium pentobarbital intramuscular, subcutaneous, or slow at the rate of 3 mg per pound of body intravenous injection. weight. (ii) Dogs and cats: Administer 0.5 to 1 (2) Indications for use. As an analgesic mg per pound of body weight by and tranquilizer and for general anes- intramuscular or subcutaneous injec- thesia. tion. Doses may be repeated at 8 to 12 (3) Limitations. Federal law restricts hours, if necessary, to produce desired this drug to use by or on the order of a effect. licensed veterinarian. (2) Indications for use. For use in con- [79 FR 16187, Mar. 25, 2014] ditions in which antihistaminic therapy may be expected to alleviate some § 522.810 Embutramide, chloroquine, signs of disease in horses, dogs, and and lidocaine solution. cats. (a) Specifications. Each milliliter (3) Limitations. Do not use in horses (mL) of solution contains 135 milli- intended for human consumption. Fed- grams (mg) embutramide; 45 mg eral law restricts this drug to use by or chloroquine phosphate, U.S.P.; and 1.9 on the order of a licensed veterinarian. mg lidocaine, U.S.P. [79 FR 16187, Mar. 25, 2014] (b) Sponsor. See No. 000859 in § 510.600(c) of this chapter. § 522.800 Droperidol and fentanyl. (c) Conditions of use in dogs—(1) One mL per 5 pounds of body (a) Specifications. Each milliliter of Amount. solution contains 20 milligrams (mg) of weight. droperidol and 0.4 mg of fentanyl cit- (2) Indications for use. For euthanasia. rate. (3) Limitations. Not for use in animals intended for food. Federal law restricts (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. this drug to use by or on the order of a licensed veterinarian. (c) Conditions of use—(1) Amount. (i) For analgesia and tranquilization, [70 FR 36337, June 23, 2005, as amended at 78 administer as follows: FR 17597, Mar. 22, 2013] (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:

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(1) 22.7 milligrams (mg) enrofloxacin of BRD in beef and non-lactating dairy or cattle at high risk of developing BRD (2) 100 mg enrofloxacin. associated with M. haemolytica, P. (b) Sponsors. See sponsor numbers in multocida, H. somni and M. bovis. § 510.600(c) of this chapter: (B) Multiple-day therapy: For the (1) No. 000859 for use of products de- treatment of bovine respiratory disease scribed in paragraph (a) as in para- (BRD) associated with Mannheimia graph (e) of this section; and haemolytica, Pasteurella multocida, and (2) No. 055529 for use of product de- Histophilus somni in beef and non-lac- scribed in paragraph (a)(2) as in para- tating dairy cattle. graphs (e)(2)(i)(B), (e)(2)(ii)(B), (iii) Limitations. Animals intended for (e)(2)(iii), (e)(3)(i), and (e)(3)(iii) of this human consumption must not be section. slaughtered within 28 days from the (c) Related tolerance. See § 556.226 of last treatment. This product is not ap- this chapter. proved for female dairy cattle 20 (d) Special considerations. Federal law months of age or older, including dry restricts this drug to use by or on the dairy cows. Use in these cattle may order of a licensed veterinarian. Fed- cause drug residues in milk and/or in eral law prohibits the extra-label use of calves born to these cows. A with- this drug in food-producing animals. drawal period has not been established (e) Conditions of use—(1) Dogs. Use the for this product in preruminating product described in paragraph (a)(1) of calves. Do not use in calves to be proc- this section as follows: essed for veal. (i) Amount. 2.5 mg per kilogram (/kg) (3) Swine. Use the product described of body weight (1.13 mg per pound) as a in paragraph (a)(2) of this section as single, intramuscular, initial dose fol- follows: lowed by use of tablets twice daily for (i) Amount. Administer 7.5 mg/kg of 2 to 3 days beyond cessation of clinical body weight once, by subcutaneous in- signs to a maximum of 10 days. jection behind the ear. (ii) Indications for use. For the man- (ii) Indications for use—(A) For the agement of diseases associated with treatment and control of swine res- bacteria susceptible to enrofloxacin. piratory disease (SRD) associated with (2) Cattle. Use the product described Actinobacillus pleuropneumoniae, in paragraph (a)(2) of this section as Pasteurella multocida, Haemophilus follows: parasuis, Streptococcus suis, Bordetella (i) Amount—(A) Single-dose therapy: bronchiseptica, and Mycoplasma For treatment of bovine respiratory hyopneumoniae. disease (BRD), administer 7.5 to 12.5 (B) For the treatment and control of mg/kg of body weight (3.4 to 5.7 mL per swine respiratory disease (SRD) associ- 100 pounds (/100 lb)) once by subcuta- ated with Actinobacillus neous injection. For control of BRD, pleuropneumoniae, Pasteurella multocida, administer 7.5 mg/kg of body weight Haemophilus parasuis, and Streptococcus (3.4 mL/100 lb) once by subcutaneous in- suis. jection. (iii) Limitations. Animals intended for (B) Multiple-day therapy: For treat- human consumption must not be ment of BRD, administer 2.5 to 5.0 mg/ slaughtered within 5 days of receiving kg of body weight (1.1 to 2.3 mL/100 lb) a single-injection dose. by subcutaneous injection. Treatment [72 FR 10597, Mar. 9, 2007, as amended at 73 should be repeated at 24-hour intervals FR 17890, Apr. 2, 2008; 73 FR 21819, Apr. 23, for 3 days. Additional treatments may 2008; 76 FR 22611, Apr. 22, 2011; 77 FR 55415, be given on days 4 and 5 to animals Sept. 10, 2012; 77 FR 76863, Dec. 31, 2012; 78 FR that have shown clinical improvement 19987, Apr. 3, 2013] but not total recovery. (ii) Indications for use—(A) Single-dose § 522.814 Eprinomectin. therapy: For the treatment of BRD as- (a) Specifications. Each milliliter of sociated with Mannheimia haemolytica, solution contains 50 milligrams (mg) Pasteurella multocida, Histophilus somni, eprinomectin. and Mycoplasma bovis in beef and non- (b) Sponsor. See No. 050604 in lactating dairy cattle; for the control § 510.600(c) of this chapter.

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(c) Related tolerances. See §§ 500.1410 bronchitis, tracheitis, pharyngitis, and 556.227 of this chapter. pleurisy), endometritis and metritis, (d) Conditions of use in cattle on pas- and bacterial wound infections caused ture—(1) Amount. Administer 1 mg/kilo- by Staphylococcus spp., Streptococcus gram of body weight by subcutaneous spp., and Corynebacterium spp., sen- injection. sitive to erythromycin. (2) Indications for use. For the treat- (iii) Limitations. Federal law restricts ment and control of the following in- this drug to use by or on the order of a ternal and external parasites: Gastro- licensed veterinarian. intestinal roundworms (adults and (2) Cats. Administer product de- fourth-stage larvae) Cooperia scribed in paragraph (a)(1) of this sec- oncophora, C. punctata, C. surnabada, tion as follows: Trichostrongylus axei, Ostertagia (i) Amount. 3 to 5 mg/lb body weight, ostertagi (including inhibited stage); intramuscularly, two to three times (adults) Haemonchus placei, daily, for up to 5 days. Oesophagostomum radiatum, O. lyrata, T. (ii) Indications for use. For the treat- colubriformis; lungworms (adults) ment of bacterial pneumonia, upper Dictyocaulus viviparus; cattle grubs respiratory infections (rhinitis, bron- Hypoderma bovis; mites Sarcoptes scabiei chitis), secondary infections associated var. bovis. Prevents reinfection with C. with panleukopenia, and bacterial oncophora, C. punctata, and T. axei for wound infections caused by Staphy- 100 days following treatment; H. placei, lococcus spp. and Streptococcus spp., sus- O. radiatum, O. lyrata, and O. ostertagi ceptible to erythromycin. for 120 days following treatment; and (iii) Limitations. Federal law restricts D. viviparus for 150 days following this drug to use by or on the order of a treatment. licensed veterinarian. (3) Limitations. Federal law restricts this drug to use by or on the order of a (3) Cattle. Administer products de- licensed veterinarian. Animals in- scribed in paragraph (a) of this section tended for human consumption must as follows: not be slaughtered within 48 days of (i) Amount. 4 mg/lb body weight by the last treatment. Do not use in fe- deep intramuscular injection once male dairy cattle 20 months of age or daily for up to 5 days. older. Use in lactating dairy cows may (ii) Indications for use. For the treat- cause drug residues in milk. A with- ment of bovine respiratory disease drawal period has not been established (shipping fever complex and bacterial for pre-ruminating calves. Do not use pneumonia) associated with Pasteurella in calves to be processed for veal. multocida susceptible to erythromycin. (iii) Limitations. Do not use in female [76 FR 72618, Nov. 25, 2011] 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. (c) Related tolerances. See § 556.230 of [72 FR 69142, Dec. 7, 2007, as amended at 79 this chapter. FR 16187, Mar. 25, 2014] (d) Conditions of use— (1) Dog. Admin- ister product described in paragraph § 522.840 Estradiol. (a)(1) of this section as follows: (a) Specifications. Each silicone rub- (i) Amount. 3 to 5 mg per pound (/lb) ber implant contains 25.7 or 43.9 milli- body weight, intramuscularly, two to grams (mg) estradiol and is coated with three times daily, for up to 5 days. not less than 0.5 mg oxytetracycline (ii) Indications for use. For the treat- powder. ment of bacterial pneumonia, upper (b) Sponsor. See No. 000986 in respiratory infections (tonsillitis, § 510.600(c) of this chapter.

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(c) Related tolerances. See § 556.240 of ear implantation, one dose per animal; this chapter. not for use in dairy or beef replacement (d) Conditions of use. For implanta- heifers. Safety and effectiveness have tion in steers and heifers as follows: not been established in veal calves. A (1) Amount. Insert one 25.7-mg im- withdrawal period has not been estab- plant every 200 days; insert one 43.9-mg lished for this product in implant every 400 days. preruminating calves. Do not use in (2) Indications for use. For increased calves to be processed for veal. rate of weight gain in suckling and 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]] 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. [69 FR 67818, Nov. 22, 2004, as amended at 77 (b) Sponsor. See 050604 in § 510.600(c) of FR 31723, May 30, 2012] this chapter. § 522.842 Estradiol benzoate and tes- (c) Conditions of use—(1) Amount. One tosterone propionate. implant and 2 milliliters of injection at time of implantation. (a) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in (2) Indications for use. For synchroni- paragraph (c) of this section. zation of estrus/ovulation in cycling (1) No. 054771 for use as in paragraph beef cattle and non-lactating dairy (c)(1)(i), (c)(2), and (c)(3) of this section. heifers. (2) No. 000986 for use as in paragraph (3) Limitations. Insert implant (c) of this section. subcutaneously in the ear only; then (b) Related tolerances. See §§ 556.240 immediately inject solution and 556.710 of this chapter. intramuscularly only. Counting the (c) Conditions of use. For implanta- day of implantation as day 1, remove tion in heifers as follows: the implant on day 10. Collect all im- (1) Amount. (i) 20 milligrams (mg) es- plants as they are removed and burn tradiol benzoate and 200 mg testos- them. While animals are restrained for terone propionate (one implant con- artificial insemination, avoid other sisting of 8 pellets, each pellet con- treatments such as vaccinations, dip- taining 2.5 mg estradiol benzoate and ping, pour-on grub and louse preven- 25 mg testosterone propionate) per im- tion, spraying, etc. When inseminating plant dose. without estrus detection, the entire (ii) 20 mg estradiol benzoate and 200 treated group should be started at 48 mg testosterone propionate (one implant consisting of 9 pellets, each of 8 hours after the last implant has been pellets containing 2.5 mg estradiol ben- removed and should be completed with- zoate and 25 mg testosterone propio- in 6 hours. Where estrus detection is nate, and 1 pellet containing 29 mg preferred, insemination should be ap- tylosin tartrate) per implant dose. proximately 12 hours after first detec- (2) Indications for use. For increased tion of estrus. Those that do not con- rate of weight gain and improved feed ceive can be re-bred when they return efficiency. to estrus approximately 17 to 25 days (3) Limitations. For heifers weighing after implant removal. Do not use in 400 pounds or more; for subcutaneous

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cows producing milk for human con- life management programs, and re- sumption. searchers. (d) Conditions of use—(1) Amount. Ad- [47 FR 55477, Dec. 10, 1982, as amended at 48 ministered intramuscularly by hand FR 49656, Oct. 27, 1983; 51 FR 33592, Sept. 22, 1986; 54 FR 1165, Jan. 12, 1989] syringe or syringe dart at a suitable dosage level depending upon the spe- § 522.863 Ethylisobutrazine. cies. (2) Indications for use. For the immo- (a) Specifications. Each milliliter of bilization of wild and exotic animals. solution contains 50 milligrams (mg) of (3) Limitations. Do not use in domes- ethylisobutrazine hydrochloride. tic food-producing animals. Do not use (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. Administer 1 to 2 mg per pound of body [79 FR 16188, Mar. 25, 2014] weight by intravenous injection to ef- § 522.900 Euthanasia solution. fect. (2) Indications for use. For use as a (a) Specifications. Each milliliter tranquilizer. (mL) of solution contains: (3) Limitations. Federal law restricts (1) 390 milligrams (mg) of pento- this drug to use by or on the order of a barbital sodium and 50 mg phenytoin licensed veterinarian. sodium. (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 (3) Limitations. Federal law restricts local laws, to prevent consumption of this drug to use by or on the order of a carcass material by scavenging wild- licensed veterinarian. life.’’ (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]

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§ 522.914 Fenprostalene. (c) Conditions of use in horses—(1) Amount. Administer 0.04 mg/pound (lb) (a) Specifications. (1) Each milliliter (0.09 mg/kilogram (kg)) of body weight of solution contains 0.5 milligram (mg) (BW) intravenously, once daily, for up fenprostalene. to 5 days. If further treatment is need- (2) Each milliliter of solution con- ed, firocoxib oral paste can be adminis- tains 0.25 mg fenprostalene. tered at a dosage of 0.045 mg/lb (0.1 mg/ (b) Sponsor. See No. 054771 in kg) of BW for up to an additional 9 § 510.600(c) of this chapter for use of days of treatment. product described in paragraph (a)(1) as (2) Indications for use. For the control in paragraph (e)(1) of this section; and of pain and inflammation associated for use of product described in para- with osteoarthritis. graph (a)(2) as in paragraph (e)(2) of (3) Limitations. Do not use in horses this section. intended for human consumption. Fed- (c) Related tolerances. See § 556.277 of eral law restricts this drug to use by or this chapter. on the order of a licensed veterinarian. (d) Special considerations. Labeling [75 FR 59611, Sept. 28, 2010] shall bear the following statements: Women of childbearing age, § 522.955 Florfenicol. asthmatics, and persons with bronchial (a) Specifications. Each milliliter and other respiratory problems should (mL) of 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 vehicle n-methyl-2-pyrrolidone. washed off immediately with soap and (b) Sponsor. See No. 000061 in water. § 510.600(c) of this chapter for use of (e) Conditions of use—(1) Cattle—(i) In- product described in paragraph (a)(1) as dications for use and amount—(A) For in paragraph (d)(1)(i) and for use of feedlot heifers to induce abortion when product described in paragraph (a)(2) as pregnant 150 days or less, administer 1 in paragraph (d)(1)(ii). mg (2 milliliter (mL)) subcutaneously. (c) Related tolerance. See § 556.283 of (B) For beef or nonlactating dairy this chapter. cattle for estrus synchronization, ad- (d) Conditions of use—(1) Cattle—(i) 300 minister a single or two 1-mg (2-mL) mg/mL florfenicol in 2-pyrrolidone and doses subcutaneously, 11 to 13 days triacetin (inactive vehicles). apart. (A) Amount. 40 mg/kilogram (kg) body (ii) Limitations. Federal law restricts weight as a single subcutaneous injec- this drug to use by or on the order of a tion. licensed veterinarian. (B) Indications for use. For treatment (2) Swine—(i) Amount. Administer a of bovine respiratory disease (BRD) as- single injection of 0.25 mg (1 mL) sociated with Mannheimia haemolytica, subcutaneously. Pasteurella multocida, Histophilus somni, (ii) Indications for use. For the induc- and Mycoplasma bovis in beef and non- tion of parturition in sows and gilts lactating dairy cattle. pregnant at least 112 days. (C) Limitations. Do not slaughter (iii) Limitations. Federal law restricts within 44 days of treatment. This drug this drug to use by or on the order of a product is not approved for use in fe- licensed veterinarian. male dairy cattle 20 months of age or older, including dry dairy cows. Use in [79 FR 16188, Mar. 25, 2014] these cattle may cause drug residues in milk and/or in calves born to these § 522.930 Firocoxib. cows. A withdrawal period has not been (a) Specifications. Each milliliter of established in preruminating calves. solution contains 20 milligrams (mg) Do not use in calves to be processed for firocoxib. veal. Federal law restricts this drug to (b) Sponsors. See No. 050604 in use by or on the order of a licensed vet- § 510.600(c) of this chapter. erinarian.

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(ii) 300 mg/mL florfenicol in n-meth- 100 lbs) once, by subcutaneous injec- yl-2-pyrrolidone (inactive vehicle). tion. (A)(1) Amount. 20 mg/kg of body (2) Indications for use. For treatment weight as an intramuscular injection. of bovine respiratory disease (BRD) as- A second dose should be administered sociated with Mannheimia haemolytica, 48 hours later. Alternatively, 40 mg/kg Pasteurella multocida, Histophilus somni, of body weight as a single subcuta- and Mycoplasma bovis, and control of neous injection may be used. BRD-associated pyrexia in beef and (2) Indications for use. For treatment non-lactating dairy cattle. of BRD associated with Mannheimia (Pasteurella) haemolytica, P. multocida, (3) Limitations. Animals intended for and Haemophilus somnus. For treatment human consumption must not be of bovine interdigital phlegmon (foot slaughtered within 38 days of treat- rot, acute interdigital necrobacillosis, ment. This drug product is not ap- infectious pododermatitis) associated proved for use in female dairy cattle 20 with Fusobacterium necrophorum and months of age or older, including dry Bacteroides melaninogenicus. dairy cows. Use in these cattle may (B)(1) Amount. 40 mg/kg of body cause drug residues in milk and/or in weight as a single subcutaneous injec- calves born to these cows. A with- tion. drawal period has not been established (2) Indications for use. For control of in preruminating calves. Do not use in respiratory disease in cattle at high calves to be processed for veal. Federal risk of developing BRD associated with law restricts this drug to use by or on Mannheimia (Pasteurella) haemolytica, P. the order of a licensed veterinarian. multocida, and Haemophilus somnus. (C) Limitations. Do not slaughter [75 FR 1275, Jan. 11, 2010, as amended at 75 within 28 days of last intramuscular FR 54018, Sept. 3, 2010; 79 FR 18158, Apr. 1, treatment or within 38 days of subcuta- 2014] neous treatment. This drug product is not approved for use in female dairy § 522.960 Flumethasone injectable dosage forms. cattle 20 months of age or older, including dry dairy cows. Use in these § 522.960a Flumethasone suspension. cattle may cause drug residues in milk and/or in calves born to these cows. A (a) Specifications. Each milliliter of withdrawal period has not been estab- suspension contains 2 milligrams (mg) lished in preruminating calves. Do not of flumethasone. use in calves to be processed for veal. (b) Sponsor. See No. 054771 in Federal law restricts this drug to use § 510.600(c) of this chapter. by or on the order of a licensed veteri- (c) Conditions of use in horses—(1) narian. Amount. Administer 6 to 10 mg by (2) [Reserved] intra-articular injection. Dosage is [73 FR 21041, Apr. 18, 2008, as amended at 74 limited to a single injection per week FR 66574, Dec. 16, 2009; 79 FR 18158, Apr. 1, in any one synovial structure. 2014] (2) Indications for use. For use in the various disease states involving § 522.956 Florfenicol and flunixin. synovial structures (joints) of horses (a) Specifications. Each milliliter where excessive synovial fluid of in- (mL) of solution contains 300 milli- flammatory origin is present and where grams (mg) florfenicol and 16.5 mg permanent structural changes do not flunixin (27.37 mg flunixin meglumine). exist. Such conditions include arthri- (b) Sponsor. See No. 000061 in tis, carpitis, and osselets. § 510.600(c) of this chapter for use as in (3) Limitations. Do not use in horses paragraph (d) of this section. intended for human consumption. Fed- (c) Tolerances. See §§ 556.283 and 556.286 of this chapter. eral law restricts this drug to use by or (d) Conditions for use in cattle—(1) on the order of a licensed veterinarian. Amount. 40 mg florfenicol/kg body [79 FR 16188, Mar. 25, 2014] weight (BW) and 2.2 mg flunixin/kg BW (equivalent to 2 mL/15 kg BW or 6 mL/

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§ 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 joint. (c) Conditions of use in dogs—(1) (ii) Indications for use. For use in the Amount. Administer by intramuscular treatment of musculoskeletal condi- injection as follows: Dogs weighing up tions due to inflammation of muscles to 10 pounds (lbs): 2 mg; dogs weighing or joints and accessory structures 10 to 25 lbs: 4 mg; dogs weighing over 25 where permanent structural changes do lbs: 8 mg. Dosage should be adjusted not exist, e.g., arthritis, osteoarthritis, according to the weight of the animal, disc syndrome, and myositis (in septic the severity of the symptoms, and the arthritis, appropriate antibacterial response noted. Dosage by injection therapy should be concurrently admin- should not exceed 3 days of therapy. istered); certain acute and chronic With chronic conditions intramuscular dermatoses of varying etiology to help therapy may be followed by oral ad- control associated pruritus, irritation, ministration of flumethasone tablets and inflammation; otitis externa in at a daily dose of from 0.0625 to 0.25 mg conjunction with topical medication; per animal. allergic states, e.g., hives, urticaria, (2) Indications for use. For use in cer- and insect bites; and shock and shock- tain acute and chronic canine like states by intravenous administra- dermatoses of varying etiology to help tion. control the pruritus, irritation, and in- (iii) Limitations. Federal law restricts flammation associated with these con- this drug to use by or on the order of a ditions. licensed veterinarian. (3) Limitations. Federal law restricts (3) Cats—(i) Amount. Administer this drug to use by or on the order of a 0.03125 to 0.125 mg daily by intravenous, licensed veterinarian. intramuscular, or subcutaneous injec- [79 FR 16188, Mar. 25, 2014] tion. (ii) Indications for use. For use in the § 522.960c Flumethasone solution. treatment of certain acute and chronic (a) Specifications. Each milliliter of dermatoses of varying etiology to help solution contains 0.5 milligrams (mg) control associated pruritus, irritation, of flumethasone. and inflammation. (b) Sponsor. See No. 054771 in (iii) 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. It is used as fol- licensed veterinarian. lows: [79 FR 16188, Mar. 25, 2014] (1) Horses—(i) Amount. Administer 1.25 to 2.5 milligrams (mg) daily by in- § 522.970 Flunixin. travenous, intramuscular, or intra-ar- (a) Specifications. Each milliliter of ticular injection. solution contains flunixin meglumine (ii) Indications for use. For use in the equivalent to 50 milligrams (mg) treatment of musculoskeletal condi- flunixin. tions due to inflammation, where per- (b) Sponsors. See sponsors in manent structural changes do not § 510.600(c) of this chapter for use as in exist, e.g., bursitis, carpitis, osselets, paragraph (e) of this section. and myositis; and allergic states, e.g., (1) See Nos. 000061, 055529, and 061623 hives, urticaria, and insect bites. for use as in paragraph (e) of this sec- (iii) Limitations. Do not use in horses tion. intended for human consumption. Fed- (2) See No. 054771 for use as in para- eral law restricts this drug to use by or graph (e)(1) of this section. on the order of a licensed veterinarian. (3) See Nos. 057561 and 059130 for use (2) Dogs—(i) Amount. Administer as in paragraphs (e)(1) and (2) of this 0.0625 to 0.25 mg daily by intravenous, section.

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(c) Related tolerances. See § 556.286 of (ii) Indications for use. For the control this chapter. of pyrexia associated with swine res- (d) Special considerations. Federal law piratory disease. restricts this drug to use by or on the (iii) Limitations. Swine must not be order of a licensed veterinarian. slaughtered for human consumption (e) Conditions of use—(1) Horses—(i) within 12 days of last treatment. Amount. 0.5 mg per pound (/lb) of body [42 FR 39103, Aug. 2, 1977, as amended at 52 weight per day, intravenously or FR 7832, Mar. 13, 1987; 60 FR 54942, Oct. 27, intramuscularly, for up to 5 days. 1995; 62 FR 22888, Apr. 28, 1997; 63 FR 38749, (ii) Indications for use. For alleviation July 20, 1998; 67 FR 9400, Mar. 1, 2002; 68 FR of inflammation and pain associated 70701, Dec. 19, 2003; 69 FR 53618, Sept. 2, 2004; with musculoskeletal disorders, and al- 69 FR 60308, Oct. 8, 2004; 70 FR 48868, Aug. 22, leviation of visceral pain associated 2005; 70 FR 70998, Nov. 25, 2005; 71 FR 15564, with colic. Mar. 29, 2006; 71 FR 16222, Mar. 31, 2006; 73 FR 2809, Jan. 16, 2008; 73 FR 28037, May 15, 2008; (iii) Limitations. Do not use in horses 74 FR 6994, Feb. 12, 2009; 74 FR 34236, July 15, intended for human consumption. 2009; 75 FR 13225, Mar. 19, 2010; 75 FR 76260, (2) Cattle—(i) Amounts and indications Dec. 8, 2010; 79 FR 16189, Mar. 25, 2014] for use—(A) Administer 1.1 to 2.2 mg/ kilogram (kg) (0.5 to 1.0 mg/lb) of body § 522.995 Fluprostenol. weight per day intravenously, as a sin- (a) Specifications. Each milliliter of gle dose or divided into two doses ad- solution contains fluprostenol sodium ministered at 12-hour intervals, for up equivalent to 50 micrograms (μg) of to 3 days for control of pyrexia associ- fluprostenol. ated with bovine respiratory disease (b) Sponsor. See No. 000859 in and endotoxemia or for control of in- § 510.600(c) of this chapter. flammation in endotoxemia. (c) Conditions of use in horses—(1) (B) Administer 2.2 mg/kg (1.0 mg/lb) Amount. Administer 0.55 μg fluprostenol of body weight once intravenously for per kilogram of body weight by control of pyrexia associated with intramuscular injection. acute bovine mastitis. (2) Indications for use. For use in (ii) Limitations. Cattle must not be mares for its luteolytic effect to con- slaughtered for human consumption trol the timing of estrus in estrous cy- within 4 days of last treatment. Milk cling and in clinically anestrous mares that has been taken during treatment that have a corpus luteum. and for 36 hours after the last treat- (3) Limitations. Do not use in horses ment must not be used for food. Do not intended for human consumption. Fed- use in dry dairy cows. A withdrawal pe- eral law restricts this drug to use by or riod has not been established for use in on the order of a licensed veterinarian. preruminating calves. Do not use in calves to be processed for veal. [79 FR 16189, Mar. 25, 2014] (B) For control of pyrexia associated with acute bovine mastitis. § 522.1002 Follicle stimulating hormone. (iii) Limitations. Do not slaughter for food use within 4 days of last treat- (a)(1) Specifications. Each package ment. A withdrawal period has not contains 2 vials. One vial contains dry, been established for use in powdered, porcine pituitary gland preruminating calves. Do not use in equivalent to 75 units (NIH-FSH-S1) of calves to be processed for veal. For follicle stimulating hormone. The Nos. 000061, 055529, 059130, and 061623: Do other vial contains 10 milliliters of not use in dry dairy cows. Milk that aqueous diluent. has been taken during treatment and (2) Sponsor. See No. 052923 in for 36 hours after the last treatment § 510.600(c) of this chapter. must not be used for food. For No. (3) Conditions of use. (i) Dosage. 12.5 057561: Not for use in lactating or dry units of follicle stimulating hormone dairy cows. twice a day for 3 days (a total of 75 (3) Swine—(i) Amount. Administer 2.2 units). To effect regression of the cor- mg/kg (1.0 mg/lb) of body weight as a pus luteum, prostaglandin should be single intramuscular injection. given with the 5th dose.

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(ii) Indications for use. For induction (3) Limitations. Federal law restricts of superovulation in cows for proce- this drug to use by or on the order of a dures requiring the production of mul- licensed veterinarian. tiple ova at a single estrus. [61 FR 68147, Dec. 27, 1996, as amended at 71 (iii) Limitations. For intramuscular FR 28266, May 16, 2006; 74 FR 26952, June 5, use in cows that are not pregnant and 2009; 74 FR 47725, Sept. 17, 2009; 77 FR 26697, have a normal corpus luteum. Federal May 7, 2012] law restricts this drug to use by or on the order of a licensed veterinarian. § 522.1010 Furosemide. (b)(1) Specifications. The drug is a (a) Specifications—(1) Each milliliter lyophilized pituitary extract material. (mL) of solution contains 50 milligrams Each 10-milliliter vial contains an (mg) furosemide monoethanolamine. amount equivalent to 50 milligrams of (2) Each mL of solution contains 50 standard porcine follicle stimulating mg furosemide diethanolamine. hormone and is reconstituted for use (b) Sponsors. See sponsors in by addition of 10 milliliters of 0.9 per- § 510.600(c) of this chapter for use of cent aqueous sodium chloride solution. products described in paragraph (a) of (2) Sponsor. See 063112 in § 510.600(c) of this section for use as in paragraph (d) this chapter. of this section. (3) Conditions of use. (i) Dosage. Cattle (1) No. 000010 as described in para- and horses, 10–50 milligrams; sheep and graph (a)(1) of this section for use as in swine, 5–25 milligrams; dogs, 5–15 milli- paragraphs (d)(1) and (d)(2)(ii) of this grams. section. (ii) Indications for use. The drug is (2) No. 061623 as described in para- used as a supplemental source of fol- graph (a)(2) of this section for use as in licle stimulating hormone where there paragraph (d)(2)(ii) of this section. is a general deficiency in cattle, (3) No. 000859 as described in para- horses, sheep, swine, and dogs. graph (a)(2) for use as in paragraphs (iii) Limitations. Administer (d)(1), (d)(2)(i), and (d)(3) of this sec- intramuscularly, subcutaneously, or tion. intravenously. Federal law restricts (4) No. 000061 as described in para- this drug to use by or on the order of a graph (a)(2) for use as in paragraphs licensed veterinarian. (d)(1), (d)(2)(iii), and (d)(3) of this section. [58 FR 47377, Sept. 9, 1993, as amended at 62 (c) Special considerations. Federal law FR 62242, Nov. 21, 1997; 76 FR 2808, Jan. 18, restricts this drug to use by or on the 2011] order of a licensed veterinarian. (d) Conditions of use—(1) Dogs and § 522.1004 Fomepizole. cats—(i) Amount. 1.25 to 2.5 mg per (a) Specifications. Each vial contains pound (/lb) body weight once or twice 1.5 grams fomepizole (1.5 milliliter daily, intramuscularly or intra- (mL) of 1.0 gram per mL solution). venously. (b) Sponsors. See Nos. 046129 and (ii) Indications for use. For the treat- 063286 in § 510.600(c) of this chapter. ment of edema (pulmonary congestion, (c) Conditions of use in dogs—(1) ascites) associated with cardiac insuffi- Amount. 20 milligrams per kilogram ciency and acute noninflammatory tis- (mg/kg) of body weight intravenously sue edema. initially, followed by 15 mg/kg at 12 (2) Horses—(i) Amount. 250 to 500 mg and 24 hours, and 5 mg/kg at 36 hours. per animal once or twice daily, (2) Indications for use. As an antidote intramuscularly or intravenously. for ethylene glycol (antifreeze) poi- (A) Indications for use. For the treat- soning in dogs who have ingested or are ment of edema (pulmonary congestion, suspected of having ingested ethylene ascites) associated with cardiac insuffi- glycol. ciency, and acute noninflammatory tissue edema. (B) Limitations. Do not use in horses intended for human consumption.

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(ii) Amount. 0.5 mg/lb body weight Histophilus somni, and Mycoplasma bovis once or twice daily, intramuscularly or in beef and non-lactating dairy cattle; intravenously. and for the control of respiratory dis- (A) Indications for use. For treatment ease in beef and non-lactating dairy of acute noninflammatory tissue cattle at high risk of developing BRD edema. associated with M. haemolytica and P. (B) Limitations. Do not use in horses multocida. intended for human consumption. (iii) Limitations. Cattle intended for (iii) Amount. 250 to 500 mg/animal human consumption must not be once or twice daily, intramuscularly or slaughtered within 35 days from the intravenously. last treatment. Do not use in female (A) Indications for use. For the treat- dairy cattle 20 months of age or older. ment of edema (pulmonary congestion, A withdrawal period has not been es- ascites) associated with cardiac insuffi- tablished for this product in ciency, and acute noninflammatory tis- preruminating calves. Do not use in sue edema. calves to be processed for veal. Federal (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 intravenously; or 250 mg/animal twice daily [76 FR 57906, Sept. 19, 2011, as amended at 77 at 12-hour intervals, intramuscularly FR 26162, May 3, 2012] or intravenously. § 522.1020 Gelatin. (ii) Indications for use. For the treatment of physiological parturient (a) Specifications. Each 100 milliliters edema of the mammary gland and asso- contains 8 grams of gelatin in a 0.85 ciated structures. percent sodium chloride solution. (iii) Limitations. Treatment not to ex- (b) Sponsor. See No. 054771 in ceed 48 hours post-parturition. Milk § 510.600(c) of this chapter. taken during treatment and for 48 (c) Conditions of use—(1) Amount. The hours (four milkings) after the last exact dosage to be administered must treatment must not be used for food. be determined after evaluating the ani- Cattle must not be slaughtered for food mal’s condition and will vary according within 48 hours following last treat- to the size of the animal and the degree ment. of shock. A suggested dosage range for small animals such as dogs is 4 to 8 [66 FR 47961, Sept. 17, 2001, as amended at 67 FR 18086, Apr. 15, 2002; 68 FR 59881, Oct. 20, cubic centimeters per pound body 2003; 69 FR 17585, Apr. 5, 2004; 71 FR 39548, weight. The suggested dosage range for July 13, 2006; 74 FR 61516, Nov. 25, 2009; 76 FR large animals such as sheep, calves, 17338, Mar. 29, 2011; 78 FR 17597, Mar. 22, 2013; cows, or horses is 2 to 4 cubic centi- 79 FR 16189, Mar. 25, 2014] meters per pound of body weight. (2) Indications for use. For use to re- § 522.1014 Gamithromycin. store circulatory volume and maintain (a) Specifications. Each milliliter blood pressure in animals being treated (mL) of solution contains 150 milli- for shock. grams (mg) gamithromycin. (3) Limitations. Federal law restricts (b) Sponsor. See No. 050604 in this drug to use by or on the order of a § 510.600(c) of this chapter. licensed veterinarian. (c) Related tolerances. See § 556.292 of this chapter. [79 FR 16189, Mar. 25, 2014] (d) Conditions of use—(1) Cattle—(i) Amount. Administer 6 mg/kilogram of § 522.1044 Gentamicin. body weight (2 mL per 110 pounds) one (a) Specifications. Each milliliter of time by subcutaneous injection in the solution contains gentamicin sulfate neck. equivalent to 5, 50, or 100 milligrams (ii) Indications for use. For the treat- (mg) gentamicin. ment of bovine respiratory disease (b) Sponsors. See sponsors in (BRD) associated with Mannheimia § 510.600(c) of this chapter for use as in haemolytica, Pasteurella multocida, paragraph (d) of this section.

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(1) No. 000061 for use of 5 mg per mil- (iii) Limitations. For 1- to 3-day old liliter (/mL) solution in swine as in turkey poults. Administer paragraph (d)(4), 50 mg/mL solution in subcutaneously in the neck. Injected dogs and cats as in paragraph (d)(1), 50 poults must not be slaughtered for food mg/mL and 100 mg/mL solution in for at least 9 weeks after treatment. chickens and turkeys as in paragraphs (3) Chickens—(i) Amount. 0.2 milli- (d)(2) and (d)(3) of this section. gram of gentamicin per 0.2 milliliter (2) No. 058005 for use of 5 mg/mL solu- dose, using the 50- or 100-milligrams- tion in swine as in paragraph (d)(4) of per-milliliter product diluted with this section. sterile saline to a concentration of 1.0 (3) No. 054628 for use of 50 mg/mL so- milligram-per-milliliter. lution in dogs as in paragraph (d)(5) of (ii) Indications for use. In day-old this section. chickens, for prevention of early mor- (4) No. 000859 for use of 100 mg/mL so- tality caused by Escherichia coli. Sal- lution in turkeys as in paragraph (d)(2) monella typhimurium, and Pseudomonas and in chickens as in paragraph (d)(3) aeruginosa that are susceptible to of this section. gentamicin. (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- milliliter solution. (4) Swine—(i) Amount. 5 milligrams of (ii) Indications for use—(a) Dogs. For gentamicin as a single intramuscular the treatment of infections of urinary dose using 5 milligram-per-milliliter tract (cystitis, nephritis), respiratory solution. tract (tonsillitis, pneumonia, (ii) Indications for use. In piglets up to tracheobronchitis), skin and soft tissue 3 days old for treatment of porcine (pyodermatitis, wounds, lacerations, colibacillosis caused by strains of E. peritonitis). coli sensitive to gentamicin. (b) Cats. For the treatment of infec- (iii) Limitations. For single tions of urinary tract (cystitis, nephri- intramuscular dose in pigs up to 3 days tis), respiratory tract (pneumonitis, of age only. Do not slaughter treated pneumonia, upper respiratory tract in- animals for food for at least 40 days fol- fections), skin and soft tissue (wounds, lowing treatment. lacerations, peritonitis), and as sup- (5) Dogs—(i) Amount. 2 milligrams of portive therapy for secondary bacterial gentamicin per pound of body weight, infections associated with twice daily on the first day, then once panleucopenia. daily. (iii) Limitations. Administer (ii) Indications for use. For use in the intramuscularly or subcutaneously. If treatment of urinary tract infections response is not noted after 7 days, the (cystitis) caused by Proteus mirabilis, antibiotic sensitivity of the infecting Escherichia coli, and Staphylococcus organism should be retested. Federal aureus. law restricts this drug to use by or on the order of a licensed veterinarian. (iii) Limitations. Administer intramuscularly or subcutaneously. If (2) Turkeys—(i) Amount. One milligram of gentamicin per 0.2 milliliter no improvement is seen after 3 days, dose, using the 50- or 100-milligrams- treatment should be discontinued and per-milliliter product diluted with the diagnosis reevaluated. Treatment sterile saline to a concentration of 5 milligrams-per-milliliter. (ii) Indications for use. As an aid in the prevention of early mortality due to Arizona paracolon infections susceptible to gentamicin.

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not to exceed 7 days. Federal law re- (2) Limitations. Federal law restricts stricts this drug to use by or on the this drug to use by or on the order of a order of a licensed veterinarian. licensed veterinarian. [43 FR 1942, Jan. 13, 1978, as amended at 48 [78 FR 17867, Mar. 25, 2013] FR 791, Jan. 7, 1983; 51 FR 15606, Apr. 25, 1986; 52 FR 7832, Mar. 13, 1987; 53 FR 40727, Oct. 18, § 522.1075 Gonadorelin diacetate tetra- 1988; 60 FR 29985, June 7, 1995; 61 FR 24441, hydrate. May 15, 1996; 62 FR 45157, Aug. 26, 1997; 63 FR 59714, Nov. 5, 1998; 63 FR 68182, Dec. 10, 1998; (a) Specifications. Each milliliter of 65 FR 45877, July 26, 2000; 71 FR 76901, Dec. 22, solution contains 50 micrograms (μg) of 2006; 78 FR 17597, Mar. 22, 2013; 78 FR 21060, gonadorelin diacetate tetrahydrate. Apr. 9, 2013] (b) Sponsors. See Nos. 000061, 050604, and 059130 in § 510.600(c) of this chapter. § 522.1066 Glycopyrrolate. (c) Conditions of use in cattle. It is (a) Specifications. Each milliliter of used as follows: solution contains 0.2 milligram (1) Amount. 100 μg per cow as a single glycopyrrolate. intramuscular or intravenous injec- (b) Sponsors. See Nos. 000859 and tion. 054771 in § 510.600(c) of this chapter. (2) Indications for use. For the treat- (c) Conditions of use in dogs and cats— ment of ovarian cysts in dairy cattle. (1) Amount. 5 micrograms per pound of body weight (0.25 milliliter per 10 (3) Limitations. Federal law restricts pounds of body weight) by intravenous, this drug to use by or on the order of a intramuscular, or subcutaneous injec- licensed veterinarian. tion in dogs or by intramuscular injec- [67 FR 68759, Nov. 13, 2002, as amended at 74 tion in cats. FR 61516, Nov. 25, 2009. Redesignated at 78 FR (2) Indications for use. As a 17867, Mar. 25, 2013] preanesthetic agent. (3) Limitations. Federal law restricts § 522.1077 Gonadorelin hydrochloride. this drug to use by or on the order of a (a) Specifications. Each milliliter of licensed veterinarian. solution contains 50 micrograms (mcg) [71 FR 64451, Nov. 2, 2006, as amended at 78 of gonadorelin (as hydrochloride). FR 17597, Mar. 22, 2013; 79 FR 16189, Mar. 25, (b) Sponsor. See No. 054771 in 2014] § 510.600(c) of this chapter. (c) Conditions of use in cattle—(1) Indi- § 522.1073 Gonadorelin acetate. cations for use and amounts—(i) For the (a) Specifications. Each milliliter of treatment of ovarian follicular cysts in solution contains 100 micrograms (μg) cattle, administer 100 mcg gonadorelin of gonadorelin as gonadorelin acetate. by intramuscular injection. (b) Sponsor. See No. 068504 in (ii) For use with dinoprost § 510.600(c) of this chapter. tromethamine to synchronize estrous (c) Conditions of use in cattle—(1) Indi- cycles to allow fixed-time artificial in- cations for use and amounts. semination (FTAI) in lactating dairy (i) For the treatment of ovarian fol- cows, administer to each cow 100 to 200 licular cysts in dairy cattle. Admin- mcg gonadorelin by intramuscular in- μ ister 100 g gonadorelin by jection, followed 6 to 8 days later by 25 intramuscular or intravenous injec- mg dinoprost tromethamine by tion. intramuscular injection, followed 30 to (ii) For use with cloprostenol sodium 72 hours later by 100 to 200 mcg to synchronize estrous cycles to allow gonadorelin by intramuscular injec- for fixed-time artificial insemination tion. in lactating dairy cows and beef cows. (2) Limitations. Dinoprost Administer to each cow 100 μg tromethamine as provided by sponsor gonadorelin by intramuscular injec- No. 054771 in § 510.600(c) of this chapter. tion, followed 6 to 8 days later by 500 μg Federal law restricts this drug to use cloprostenol by intramuscular injec- by or on the order of a licensed veteri- tion, followed 30 to 72 hours later by 100 narian. μg gonadorelin by intramuscular injection. [78 FR 63872, Oct. 25, 2013]

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§ 522.1079 Serum gonadotropin and behavior or examination of the ovaries chorionic gonadotropin. per rectum indicates retreatment. (a) Specifications. Each dose consists (A) 10,000 USP units by of 400 international units (I.U.) serum intramuscular injection. gonadotropin and 200 I.U. chorionic (B) 500 to 2,500 USP units by gonadotropin as a freeze-dried powder intrafollicular injection. to be reconstituted with 5 milliliters of (C) 2,500 to 5,000 USP units by intra- sterile aqueous diluent. venous injection. (b) Sponsor. See No. 000061 in (ii) Indications for use. For parenteral § 510.600(c) of this chapter. use in cows for treatment of nympho- 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. 1 female brood finfish. (i) Gilts. For use only in gilts over 5 ⁄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, ditions may farrow smaller than nor- 2012; 79 FR 16189, Mar. 25, 2014] mal litters. § 522.1083 Gonadotropin releasing fac- [55 FR 1405, Jan. 16, 1990, as amended at 58 tor analog-diphtheria toxoid con- FR 52222, Oct. 7, 1993; 74 FR 61516, Nov. 25, jugate. 2009] (a) Specifications. Each milliliter of solution contains 0.2 milligrams (mg) § 522.1081 Chorionic gonadotropin. gonadotropin releasing factor analog- (a) Specifications. Each vial contains diphtheria toxoid conjugate. 5,000, 10,000 or 20,000 USP units of (b) Sponsor. See No. 054771 in lyophilized powder for constitution § 510.600(c) of this chapter. with accompanying diluent to a 10-mil- (c) Conditions of use in swine— (1) liliter solution. Amount. Administer 0.4 mg (2 milliliter (b) Sponsors. See sponsors in (mL)) by subcutaneous injection no § 510.600(c) of this chapter for use as in earlier than 9 weeks of age. A second paragraph (d) of this section. subcutaneous injection of 0.4 mg (2 mL) (1) Nos. 000402 and 054771 for use as in should be administered at least 4 weeks paragraphs (d)(1)(i)(A), (d)(1)(i)(B) and after the first dose. (d)(1)(i)(C) of this section. (2) Indications for use. For the tem- (2) [Reserved] porary immunological castration (sup- (3) No. 000061 for use as in paragraphs pression of testicular function) and re- (d)(1)(i)(A) and (d)(2) of this section. duction of boar taint in intact male (c) Related tolerances. See § 556.304 of pigs intended for slaughter. this chapter. (3) Limitations. Federal law restricts (d) Conditions of use—(1) Cattle—(i) this drug to use by or on the order of a Amount. As a single dose. Dosage may licensed veterinarian. Pigs should be be repeated in 14 days if the animal’s slaughtered no earlier than 3 weeks

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

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(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 of equine carpal and fetlock joint dys- [49 FR 45124, Nov. 15, 1984, as amended at 51 function caused by traumatic and/or FR 11438, Apr. 3, 1986; 51 FR 25032, July 10, 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; (iii) Limitations. Do not use in horses 61 FR 59003, Nov. 20, 1996; 63 FR 59216, Nov. 3, intended for human consumption. Fed- 1998; 71 FR 1689, Jan. 11, 2006; 71 FR 39204, eral law restricts this drug to use by or July 12, 2006; 75 FR 1274, Jan. 11, 2010; 75 FR on the order of a licensed veterinarian. 10167, Mar. 5, 2010; 78 FR 73698, Dec. 9, 2013; 79 (e)(1) Specifications. Each milliliter of FR 16189, Mar. 25, 2014] 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. (2) Sponsors. See sponsors in (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter: § 510.600(c) of this chapter. (i) No. 000859 for use of products de- (c) Conditions of use—(1) Amount. 5 to scribed in paragraph (e)(1) as in para- 10 milliliters (125 to 250 milligrams) in- graph (e)(3) of this section. travenously or intramuscularly once or (ii) No. 064847 for use of product de- twice a day. After onset of diuresis, scribed in paragraph (e)(1)(i) as in para- treatment may be continued with an graph (e)(3) of this section. orally administered maintenance dose. (3) Conditions of use—(i) Amount. 20 (2) Indications for use. For use in cat- mg of the product described in para- tle as an aid in the treatment of graph (e)(1)(i) of this section by intra- postparturient udder edema. articular injection into the carpus or (3) Limitations. Milk taken from dairy fetlock; or 40 mg of the product de- animals during treatment and for 72 scribed in paragraph (e)(1)(i) or (e)(1)(ii) hours (6 milkings) after the latest of this section by slow intravenous in- treatment must not be used for food. jection into the jugular vein. Treat- Federal law restricts this drug to use

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by or on the order of a licensed veteri- (2) Indications for use. For the treat- narian. ment of clinical signs of babesiosis and/ or demonstrated Babesia organisms in [43 FR 59058, Dec. 19, 1978, as amended at 62 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 eral law restricts this drug to use by or percent less than the once daily dose on the order of a licensed veterinarian. required to attain an acceptable nadir. (ii) Indications for use. For the reduc- [79 FR 16190, Mar. 25, 2014] tion of hyperglycemia and hyperglycemia-associated clinical signs in § 522.1156 Imidocarb solution. dogs with diabetes mellitus. (a) Specifications. Each milliliter of (iii) Limitations. Federal law restricts solution contains 120 milligrams (mg) this drug to use by or on the order of a of imidocarb dipropionate. licensed veterinarian. (b) Sponsor. See No. 000061 in (2) Cats—(i) Amount—(A) Porcine insu- § 510.600(c) of this chapter. lin zinc. Administer an initial dose of 1 (c) Conditions of use in dogs—(1) to 2 IU by subcutaneous injection. In- Amount. Administer 6.6 mg per kilo- jections should be given twice daily at gram (3 mg per pound) of body weight approximately 12-hour intervals. For by intramuscular injection. Repeat the cats fed twice daily, the injections dose after 2 weeks for a total of two should be concurrent with or right treatments. after a meal. For cats fed ad libitum,

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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 059120 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 [69 FR 25827, May 10, 2004, as amended at 73 anemia, administer 1 mL by FR 21042, Apr. 18, 2008; 74 FR 61517, Nov. 25, intramuscular injection at 2 to 5 days 2009; 74 FR 66048, Dec. 14, 2009] of age. Dosage may be repeated at 2 weeks of age. § 522.1182 Iron injection. (ii) For treatment of iron deficiency (a) Specifications. See § 510.440 of this anemia, administer 1 to 2 mL by chapter. Each milliliter (mL) of solu- intramuscular injection at 5 to 28 days tion contains the equivalent of: of age. (1) 100 milligrams (mg) of elemental (5) No. 054771 for use of product de- iron derived from: scribed in paragraph (a)(1)(iii) of this (i) Ferric hydroxide; section as follows: (ii) Ferric oxide; or (i) For prevention of anemia due to (iii) Elemental iron. iron deficiency, administer 100 mg by (2) 200 mg of elemental iron derived intramuscular or subcutaneous injec- from ferric hydroxide. tion at 2 to 4 days of age. (b) Sponsors and conditions of use. It is (ii) For treatment of anemia due to used in baby pigs by sponsors in iron deficiency, administer 100 mg by § 510.600(c) of this chapter as follows: intramuscular or subcutaneous injec- (1) Nos. 000859 and 042552 for use of tion up to 4 weeks of age. product described in paragraph (a)(1)(i) (6) Nos. 000859 and 058005 for use of of this section as follows: product described in paragraph (i) For prevention of iron deficiency (a)(1)(iii) of this section as follows: anemia, inject 100 mg (1 mL) by (i) For prevention of anemia due to intramuscular injection at 2 to 4 days iron deficiency, administer 100 mg by of age. intramuscular injection at 2 to 4 days (ii) For treatment of iron deficiency of age. anemia, inject 100 mg (1 mL) by (ii) For treatment of anemia due to intramuscular injection. Dosage may iron deficiency, administer 100 mg by be repeated in approximately 10 days. intramuscular injection. Treatment (2) No. 054771 for use of product de- may be repeated in 10 days. scribed in paragraph (a)(1)(i) of this (7) Nos. 000859 and 042552 for use of section as follows: product described in paragraph (a)(2) of (i) For the prevention of anemia due this section as follows: to iron deficiency, administer an ini- (i) For prevention of baby pig anemia tial intramuscular injection of 100 mg due to iron deficiency, intramuscularly

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inject 200 mg of elemental iron (1 mL) treating acute hypersensitivity reac- at 1 to 3 days of age. tions; and as an aid in correcting cir- (ii) For treatment of baby pig anemia culatory defects associated with severe due to iron deficiency, intramuscularly toxicity and shock. inject 200 mg of elemental iron at the (iii) Limitations. Animals intended for first sign of anemia. human consumption should not be (8) No. 059120 for use of product de- slaughtered within 7 days of last treat- scribed in paragraph (a)(2) of this sec- ment. Federal law restricts this drug tion as follows: to use by or on the order of a licensed (i) For prevention of iron deficiency veterinarian. anemia, administer 200 mg [79 FR 16190, Mar. 25, 2014] intramuscularly on or before 3 days of age. § 522.1192 Ivermectin. (ii) For treatment of iron deficiency (a) Specifications—(1) Each milliliter anemia, administer 200 mg (mL) of solution contains 20 milligrams intramuscularly. (mg) ivermectin. [73 FR 12635, Mar. 10, 2008, as amended at 73 (2) Each mL of solution contains 10 FR 14385, Mar. 18, 2008; 78 FR 17597, Mar. 22, mg ivermectin. 2013; 78 FR 44433, July 24, 2013; 79 FR 16190, (3) Each mL of solution contains 2.7 Mar. 25, 2014] mg ivermectin. (b) Sponsors. See sponsors in § 522.1185 Isoflupredone. § 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. 000859 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 into a joint cavity, tendon sheath, or (adult) (Strongylus vulgaris, S. edentatus, bursa for local effect. Triodontophorus spp.), small strongyles (B) Swine. The usual dose for a 300- (adult and fourth stage larvae) pound animal is 5 mg by intramuscular (Cyathostomum spp., Cylicocyclus spp., injection. Cylicostephanus spp.), pinworms (adult (ii) Indications for use. For alleviation and fourth-stage larvae) (Oxyuris equi), of pain associated with generalized and large roundworms (adult) (Parascaris acute localized arthritic conditions; for equorum), hairworms (adult)

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

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(parasitic stages) (Hypoderma bovis, H. (b) Sponsors. See Nos. 000859, 026637, lineatum); lice (Linognathus vituli, 054628, 054771, 061690, and 063286 in Haematopinus eurysternus, Solenopotes § 510.600(c) of this chapter. capillatus); mites (Psoroptes ovis (syn. P. (c) Special considerations. Federal law communis var. bovis), Sarcoptes scabiei restricts this drug to use by or on the var. bovis); and for control of infections order of a licensed veterinarian. of D. viviparus and O. radiatum for 28 (d) Conditions of use—(1) Cats—(i) days afer treatment; O. ostertagi, T. Amount. 5 to 15 mg/pound body weight axei, and C. punctata for 21 days after intramuscularly, depending on the ef- treatment; and H. placei and C. fect desired. oncophora for 14 days after treatment. (ii) Indications for use. For restraint (3) Limitations. For subcutaneous use or as the sole anesthetic agent in diag- only. Not for intravenous or nostic or minor, brief surgical proce- intramuscular use. Do not treat cattle dures that do not require skeletal mus- within 49 days of slaughter. Because a cle relaxation. withdrawal time in milk has not been (2) Subhuman primates—(i) Amount. 3 established, do not use in female dairy to 15 mg/kilogram body weight cattle of breeding age. Do not use in intramuscularly, depending upon the other animal species because severe ad- species, general condition, and age of verse reactions, including fatalities in the subject. dogs, may result. A withdrawal period (ii) Indications for use. For restraint. has not been established for this prod- [67 FR 17283, Apr. 10, 2002, as amended at 73 uct in preruminating calves. Do not FR 8192, Feb. 13, 2008; 74 FR 36111, July 22, use in calves to be processed for veal. 2009; 74 FR 66573, Dec. 16, 2009; 75 FR 10167, Mar. 5, 2010; 78 FR 21060, Apr. 9, 2013. Redesig- [55 FR 38984, Sept. 24, 1990, as amended at 62 nated and amended at 79 FR 16191] FR 14302, Mar. 26, 1997; 62 FR 63271, Nov. 28, 1997; 64 FR 26671, May 17, 1999; 69 FR 31735, § 522.1223 Ketamine, promazine, and June 7, 2004; 72 FR 27734, May 17, 2007; 77 FR aminopentamide. 64717, Oct. 23, 2012] (a) Specifications. Each milliliter of § 522.1204 Kanamycin. solution contains ketamine hydrochloride equivalent to 100 milligrams (a) Specifications. Each milliliter of (mg) ketamine base activity, 7.5 (mg) solution contains 50 or 200 milligrams of promazine hydrochloride, and 0.0625 (mg) of kanamycin as kanamycin sul- mg of aminopentamide hydrogen sulfate. fate. (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) Conditions of use in dogs and cats— (c) Conditions of use in cats—(1) (1) Amount. Administer by subcuta- Amount. Administer by intramuscular neous or intramuscular injection 5 mg injection 15 to 20 mg ketamine base per per pound of body weight per day in pound of body weight, depending on the equally divided doses at 12-hour inter- effect desired. vals. (2) Indications for use. It is used in (2) Indications for use. For the treat- cats as the sole anesthetic agent for ment of bacterial infections due to ovariohysterectomy and general sur- kanamycin sensitive organisms in dogs gery. and cats. (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. [79 FR 16191, Mar. 25, 2014] [79 FR 16190, Mar. 25, 2014] § 522.1225 Ketoprofen. § 522.1222 Ketamine. (a) Specifications. Each milliliter of (a) Specifications. Each milliliter con- solution contains 100 milligrams (mg) tains ketamine hydrochloride equiva- of ketoprofen. lent to 100 milligrams (mg) ketamine (b) Sponsor. See No. 054771 in base activity. § 510.600(c) of this chapter.

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(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 FR 29289, July 7, 1978; 43 FR 60895, Dec. 29, of inflammation and pain associated 1978; 47 FR 10807, Mar. 12, 1982; 62 FR 61625, with musculoskeletal disorders in Nov. 19, 1997; 65 FR 61090, Oct. 16, 2000; 67 FR horses. 63055, Oct. 10, 2002. Redesignated and amend- (3) Limitations. Do not use in horses ed 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. 000859 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 (Trichostrongylus, Cooperia, tions in paragraph (a)(4) of this section Nematodirus, Bunostomum, as in paragraph (e)(2) of this section. Oesophagostomum, Chabertia), and (c) Special considerations. When com- lungworms (Dictyocaulus). mon labeling for use of the drug in (ii) The 18.2 percent injection is used dogs, cats, and swine is included with as an anthelmintic in cattle for treat- the drug, all such uses are subject to ment of the following parasites: stom- the labeling requirements of § 201.105 of ach worms (Haemonchus, this chapter. Trichostrongylus, Ostertagia), intestinal (d) Related tolerances. See § 556.360 of worms (Trichostrongylus, Cooperia, this chapter. Nematodirus, Bunostomum, (e) Conditions of use. It is used for ani- Oesophagostomum) and lungworms mals as follows: (Dictyocaulus). (1) Dogs and cats—(i) Amount. 5 mg (3) Limitations. Do not administer per pound (/lb) of body weight twice more than 10 milliliters per site. Cattle daily or 10 mg/lb body weight once that are severely parasitized or main- daily by intramuscular injection; 5 to tained under conditions of constant 10 mg/lb body weight one or two times helminth exposure may require re- daily by slow intravenous injection. treatment within 2 to 4 weeks after (ii) Indications for use. Infections first treatment. Consult your veteri- caused by Gram-positive organisms, narian for assistance in the diagnosis, particularly streptococci and treatment, and control of parasitism. staphylococci. Consult your veterinarian before using (iii) Limitations. Federal law restricts in severely debilitated animals or ani- this drug to use by or on the order of a mals under severe stress. Do not ad- licensed veterinarian.

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(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] § 522.1315 Maropitant. (a) Specifications. Each milliliter of § 522.1289 Lufenuron. solution contains 10 milligrams (mg) (a) Specifications. Each milliliter of maropitant as maropitant citrate. suspension contains 10 milligrams (mg) (b) Sponsor. See No. 054771 in 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 injection once daily for up pound) of body weight every 6 months, 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] injection once daily for up to 5 con- § 522.1290 Luprostiol. secutive days. (ii) Indications for use. For the treat- (a) Specifications. Each milliliter of ment of vomiting. 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. (c) Special considerations. Labeling [72 FR 9243, Mar. 1, 2007, as amended at 77 FR shall bear the following statements: 39391, July 3, 2012; 79 FR 16191, Mar. 25, 2014] Warning: Women of childbearing age, § 522.1335 Medetomidine. asthmatics, and persons with bronchial 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. women may be unaware of their preg- (b) Sponsor. See 052483 in § 510.600(c) of nancies. Luprostiol is readily absorbed this chapter. through the skin and can cause abor- (c) Conditions of use—(1) Amount. 750 tion and/or bronchiospasms. Direct micrograms intravenously (IV) or 1,000 contact with the skin should therefore micrograms intramuscularly per be avoided. Accidental spillage on the square meter of body surface. The IV skin should be washed off immediately route is more efficacious for dental with soap and water. care. (d) Conditions of use in horses—(1) (2) Indications for use. As a sedative Amount. 7.5 mg by intramuscular injec- and analgesic in dogs over 12 weeks of tion. age to facilitate clinical examinations,

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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) Sponsor. See Nos. 000010, 016729, cious for dental care. and 055529 in § 510.600(c) of this chapter. (3) Limitations. Federal law restricts (c) Conditions of use—(1) Dogs—(i) this drug to use by or on the order of a Amount. Administer 0.09 mg per pound licensed veterinarian. (mg/lb) body weight (0.2 mg per kilo- [61 FR 21075, May 9, 1996, as amended at 79 gram (mg/kg)) by intravenous or sub- FR 16191, Mar. 25, 2014] 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. (ii) Indications for use. For the control (b) Sponsor. See No. 053923 in of pain and inflammation associated § 510.600(c) of this chapter. with osteoarthritis. (c) Conditions of use—(1) Amount. One (iii) Limitations. Federal law restricts implant per mink. this drug to use by or on the order of a (2) Indications for use. For use in licensed veterinarian. healthy male and female kit and adult (2) Cats—(i) Amount. Administer 0.14 female mink (Mustela vison) to accel- mg/lb (0.3 mg/kg) body weight as a sin- erate the fur priming cycle. gle, one-time subcutaneous injection. (3) Limitations. For subcutaneous im- (ii) Indications for use. For the control plantation in mink only. Do not im- of postoperative pain and inflamma- plant potential breeding stock. Do not tion associated with orthopedic sur- use in food-producing animals. gery, ovariohysterectomy, and castra- [59 FR 37422, July 22, 1994] tion when administered prior to surgery. § 522.1362 Melarsomine powder for in- (iii) Limitations. Federal law restricts jection. this drug to use by or on the order of a licensed veterinarian. (a) Specifications. The drug consists of a vial of lyophilized powder containing [68 FR 68724, Dec. 10, 2003, as amended at 69 50 milligrams of melarsomine FR 69523, Nov. 30, 2004; 78 FR 5715, Jan. 28, dihydrochloride which is reconstituted 2013] with the provided 2 milliliters of ster- § 522.1372 Mepivacaine. ile water for injection. (b) Sponsor. See No. 050604 in (a) Specifications. Each milliliter § 510.600(c) of this chapter. (mL) of solution contains 20 milligrams (c) Conditions of use—(1) Amount. Ad- mepivacaine hydrochloride. minister only by deep intramuscular (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. injection in the lumbar muscles (L3– L ). (c) Conditions of use in horses—(1) 5 Amount. For nerve block, 3 to 5 mL; for (2) Indications. Treatment of sta- epidural anesthesia, 5 to 20 mL; for bilized, class 1, 2, and 3 heartworm dis- intra-articular anesthesia, 10 to 15 mL; ease (asymptomatic to mild, moderate, for infiltration, as required; for anes- and severe, respectively) caused by im- thesia of the laryngeal mucosa prior to mature (4 month-old, stage L ) to ma- 5 ventriculectomy, by topical spray, 25 ture adult infections of Dirofilaria to 40 mL, by infiltration, 20 to 50 mL. immitis in dogs. (2) Indications for use. For use as a (3) Limitations. Federal law restricts local anesthetic for infiltration, nerve this drug to use by or on the order of a block, intra-articular and epidural an- licensed veterinarian. esthesia, and topical and/or infiltration [60 FR 49340, Sept. 25, 1995, as amended at 79 anesthesia of the laryngeal mucosa FR 16191, Mar. 25, 2014] prior to ventriculectomy.

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(3) Limitations. Not for use in horses antibacterial treatment of severe infec- intended for human consumption. Fed- tions. eral law restricts this drug to use by or (iii) Limitations. Federal law restricts on the order of a licensed veterinarian. this drug to use by or on the order of a licensed veterinarian. [71 FR 39547, July 13, 2006, as amended at 79 FR 16191, Mar. 25, 2014] (2) Cats—(i) Amount. Administer 10 to 20 mg by intramuscular injection. § 522.1380 Methocarbamol. (ii) Indications for use. For treatment of inflammation and related disorders; (a) Specifications. Each milliliter of treatment of allergic and dermatologic solution contains 100 milligrams (mg) disorders; and as supportive therapy to of methocarbamol. antibacterial treatment of severe infec- (b) Sponsor. See No. 054771 in tions. § 510.600(c) of this chapter. (iii) Limitations. Federal law restricts (c) Conditions of use—(1) Amount—(i) this drug to use by or on the order of a Dogs and cats. Administer by intra- licensed veterinarian. venous injection 20 mg per pound of (3) Horses—(i) Amount. Administer 200 body weight for moderate conditions or mg by intramuscular injection or 40 to 25 to 100 mg per pound of body weight 240 mg by intrasynovial injection. for severe conditions (tetanus and (ii) Indications for use. For treatment strychnine poisoning). The total cumu- of inflammation and related disorders. lative dose should not to exceed 150 mg (iii) Limitations. Do not use in horses per pound of body weight. intended for human consumption. Fed- (ii) Horses. Administer by intra- eral law restricts this drug to use by or venous injection 2 to 10 mg per pound on the order of a licensed veterinarian. of body weight for moderate conditions or 10 to 25 mg per pound of body weight [43 FR 59058, Dec. 19, 1978, as amended at 51 for severe conditions (tetanus). Addi- FR 741, Jan. 8, 1986; 53 FR 40728, Oct. 18, 1988; tional amounts may be needed to re- 62 FR 35076, June 30, 1997; 76 FR 53051, Aug. lieve residual effects and to prevent re- 25, 2011; 78 FR 21060, Apr. 9, 2013; 79 FR 16191, Mar. 25, 2014] currence of symptoms. (2) Indications for use. As an adjunct § 522.1450 Moxidectin solution. for treating acute inflammatory and (a) Each milliliter of traumatic conditions of the skeletal Specifications. solution contains 10 milligrams (mg) muscles and to reduce muscular moxidectin. spasms. (b) Sponsor. See No. 000010 in (3) Limitations. Do not use in horses § 510.600(c) of this chapter. intended for human consumption. Fed- (c) See § 556.426 of eral law restricts this drug to use by or Related tolerances. this chapter. on the order of a licensed veterinarian. (d) Special considerations. See § 500.25 [79 FR 16191, Mar. 25, 2014] 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. (b) Sponsors. See Nos. 054628 and (2) Indications for use. For treatment 054771 in § 510.600(c) of this chapter. and control of gastrointestinal (c) [Reserved] roundworms: Ostertagia ostertagi (d) Conditions of use—(1) Dogs—(i) (adults, fourth-stage larvae, and inhib- Amount. Administer 2 to 40 mg (up to ited larvae), Haemonchus placei 120 mg in extremely large breeds or (adults), Trichostrongylus axei (adults dogs with severe involvement) by and fourth-stage larvae), intramuscular injection or up to 20 mg Trichostrongylus colubriformis (adults by intrasynovial injection. and fourth-stage larvae), Cooperia (ii) Indications for use. For treatment oncophora (adults), Cooperia pectinata of inflammation and related disorders; (adults), Cooperia punctata (adults and treatment of allergic and dermatologic fourth-stage larvae), Cooperia spatulata disorders; and as supportive therapy to (adults), Cooperia surnabada (adults and

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fourth-stage larvae), Nematodirus § 522.1452 Nalorphine. helvetianus (adults), Oesophagostomum (a) Specifications. Each milliliter of (adults and fourth-stage lar- radiatum solution contains 5 milligrams of vae), Trichuris spp. (adults); nalorphine hydrochloride. lungworms: Dictyocaulus viviparus (b) Sponsor. See No. 050604 in (adults and fourth-stage larvae); grubs: § 510.600(c) of this chapter. Hypoderma bovis and Hypoderma (c) Conditions of use in dogs—(1) lineatum; mites: Psoroptes ovis Amount. One milligram per 5 pounds; (Psoroptes communis var. bovis); lice: intravenously, intramuscularly, or Linognathus vituli and Solenopotes subcutaneously. capillatus; for protection of cattle from (2) Indications for use. Respiratory reinfection with D. viviparus and O. and circulatory depression in dogs re- radiatum for 42 days after treatment, sulting from overdosage of, or unusual with H. placei for 35 days after treat- sensitivity to, morphine and certain ment, and with O. ostertagi and T. axei other narcotics. Not for depression due for 14 days after treatment. to any other cause. (3) Limitations. Do not slaughter cat- (3) Limitations. Federal law restricts tle within 21 days of treatment. Be- cause a withholding time for milk has this drug to use by or on the order of a not been established, do not use in fe- licensed veterinarian. male dairy cattle 20 months of age and [44 FR 6707, Feb. 2, 1979, as amended at 47 FR older. A withdrawal period has not 36418, Aug. 20, 1982; 62 FR 63271, Nov. 28, 1997; been established for pre-ruminating 79 FR 16191, Mar. 25, 2014] calves. Do not use in calves to be processed for veal. § 522.1465 Naltrexone. (a) Specifications. Each milliliter of [70 FR 36337, June 23, 2005, as amended at 71 solution contains 50 milligrams of FR 7414, Feb. 13, 2006; 76 FR 48714, Aug. 9, 2011] naltrexone hydrochloride. (b) Sponsor. See 053923 in § 510.600(c) of § 522.1451 Moxidectin microspheres this chapter. for injection. (c) Conditions of use in elk and moose— (a) Specifications. The drug product (1) Amount. 100 milligrams of consists of two separate vials. One con- naltrexone hydrochloride for each mil- tains 10 percent moxidectin micro- ligram of carfentanil citrate adminis- spheres, and the other contains a vehi- tered. One-quarter of the dose should cle for constitution of the moxidectin be administered intravenously and microspheres. Each milliliter of con- three-quarters of the dose should be ad- stituted, sustained-release suspension ministered subcutaneously. contains 3.4 milligrams (mg) of (2) Indications for use. As an antago- moxidectin. nist to carfentanil citrate immobiliza- (b) Sponsor. See No. 054771 in tion in free-ranging or confined elk and § 510.600(c) of this chapter. moose (Cervidae). (c) [Reserved] (3) Limitations. Do not use in domes- (d) Conditions of use; dogs—(1) Amount. tic food-producing animals. Do not use 0.17 mg per kilogram body weight in free-ranging animals for 45 days be- (0.0773 mg per pound) as a single sub- fore or during hunting season. Federal cutaneous injection. law restricts this drug to use by or on (2) Indications for use. For prevention the order of a licensed veterinarian. of heartworm disease caused by [62 FR 5320, Feb. 5, 1997, as amended at 79 FR Dirofilaria immitis; for treatment of ex- 16191, Mar. 25, 2014] isting larval and adult hookworm (Ancylostoma caninum) and Uncinaria § 522.1468 Naproxen for injection. stenocephala infections. (a) Specifications. The drug is a (3) Limitations. Federal law restricts lyophilized powder which is reconsti- this drug to use by or on the order of a tuted with sterile water for injection licensed veterinarian. to form a 10 percent sterile aqueous so- [66 FR 35756, July 9, 2001, as amended at 67 lution (100 milligrams per milliliter). FR 57944, Sept. 13, 2002; 79 FR 16191, Mar. 25, (b) Sponsor. See 054771 in § 510.600(c) of 2014] this chapter.

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(c) Conditions of use in horses—(1) Dos- subcutaneously. Administer to swine age. Five milligrams per kilogram of at a dosage level of 2 to 3 mg/100 lbs body weight intravenously followed by body weight intramuscularly. These maintenance oral therapy of 10 milli- doses may be repeated as indicated. grams per kilogram of body weight (2) Indications for use. For treating twice daily for up to 14 consecutive rumen atony; initiating peristalsis days. which causes evacuation of the bowel; (2) Indications for use. For the relief of emptying the urinary bladder; and inflammation and associated pain and stimulating skeletal muscle contrac- lameness exhibited with arthritis, as tions. well as myositis and other soft tissue (3) Limitations. Not for use in animals diseases of the musculoskeletal system producing milk, since this use will re- of the horse. sult in contamination of the milk. Fed- (3) Limitations. Not for use in horses eral law restricts this drug to use by or intended for food. Federal law restricts on the order of a licensed veterinarian. this drug to use by or on the order of a [40 FR 13858, Mar. 27, 1975, as amended at 62 licensed veterinarian. FR 61625, Nov. 19, 1997; 79 FR 16192, Mar. 25, 2014] [46 FR 26763, May 15, 1981. Redesignated and amended at 51 FR 24525, July 7, 1986; 61 FR § 522.1610 Oleate sodium. 5507, Feb. 13, 1996; 79 FR 16192, Mar. 25, 2014] (a) Specifications. Each milliliter of § 522.1484 Neomycin. solution contains 50 milligrams (mg) of (a) Specifications. Each milliliter of sodium oleate. solution contains 50 milligrams (mg) of (b) Sponsor. See No. 037990 in neomycin sulfate (equivalent to 35 mg § 510.600(c) of this chapter. of neomycin base). (c) Conditions of use in horses—(1) (b) Sponsor. See No. 054771 in Amount. Administer by parenteral in- § 510.600(c) of this chapter. jection depending on the area of response desired. An injection of 1 milli- (c) Conditions of use in dogs and cats— liter (mL) will produce a response of (1) Amount. Administer 5 mg per pound approximately 15 square centimeters. of body weight daily by intramuscular Do not inject more than 2 mL per in- or intravenous injection, divided into jection site. Regardless of the number portions administered every 6 to 8 of injection sites, the total volume hours for 3 to 5 days. used should not exceed 10 mL. (2) For the treat- Indications for use. (2) Indications for use. It is used in ment of acute and chronic bacterial in- horses to stimulate infiltration of cel- fections due to organisms susceptible lular blood components that subse- to neomycin. quently differentiate into fibrous and/ (3) Limitations. Not for parenteral use or fibrocartilagenous tissue. in food-producing animals because of (3) Limitations. Do not use in horses prolonged residues in edible tissues. intended for human consumption. Fed- Federal law restricts this drug to use eral law restricts this drug to use by or by or on the order of a licensed veteri- on the order of a licensed veterinarian. narian. [41 FR 27034, July 1, 1976, as amended at 50 [79 FR 16192, Mar. 25, 2014] FR 40966, Oct. 8, 1985; 79 FR 16192, Mar. 25, 2014] § 522.1503 Neostigmine. (a) Specifications. Each milliliter of § 522.1620 Orgotein for injection. solution contains 2 milligrams (mg) ne- (a) Specifications. Orgotein for injec- ostigmine methylsulfate. tion is packaged in a vial containing 5 (b) Sponsor. See No. 000061 in milligrams of orgotein and 10 milli- § 510.600(c) of this chapter. grams of sucrose as lyophilized sterile (c) Conditions of use—(1) Amount. Ad- nonpyrogenic powder with directions minister to cattle and horses at a dos- for dissolving the contents of the vial age level of 1 mg per (/) 100 pounds (lbs) in 2 milliliters of diluent which is so- of body weight subcutaneously. Admin- dium chloride injection, U.S.P. ister to sheep at a dosage level of 1 to (b) Sponsor. See No. 024991 in 11⁄2 mg/100 lbs body weight § 510.600(c) of this chapter.

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(c) Conditions of use—(1) Horses—(i) prerumenative (veal) calves—(i) Amounts Amount. Administer by deep and indications for use—(A) 3 to 5 mg intramuscular injection at a dosage per pound of body weight (mg/lb BW) level of 5 milligrams (mg) every other per day (/day) intramuscularly, day for 2 weeks and twice weekly for 2 subcutaneously, or intravenously for to 3 more weeks. Severe cases, both 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) It is used for Indications for use. 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 will occur much more slowly, if at all. by Moraxella bovis, or where retreat- (iii) Limitations. Federal law restricts ment for anaplasmosis is impractical. this drug to use by or on the order of a licensed veterinarian. (ii) Limitations. Exceeding the highest recommended level of drug per pound [40 FR 13858, Mar. 27, 1975, as amended at 41 of bodyweight per day, administering FR 32583, Aug. 4, 1976; 79 FR 16192, Mar. 25, more than the recommended number of 2014] treatments, and/or exceeding 10 mL § 522.1660 Oxytetracycline injectable intramuscularly or subcutaneously per dosage forms. injection site may result in antibiotic residues beyond the withdrawal time. § 522.1660a Oxytetracycline solution, Rapid intravenous administration in 200 milligrams/milliliter. cattle may result in animal collapse. (a) Specifications. Each milliliter of Oxytetracycline should be adminis- sterile solution contains 200 milligrams tered intravenously slowly over a pe- of oxytetracycline base. riod of at least 5 minutes. Discontinue (b) Sponsors. See Nos. 000010, 000859, treatment at least 28 days prior to 048164, 054771, 055529, 057561, and 061623 slaughter. Milk taken from animals in § 510.600(c) of this chapter. during treatment and for 96 hours after (c) Related tolerances. See § 556.500 of the last treatment must not be used for this chapter. food. (d) Special considerations. When la- (2) Swine—(i) Amounts and indications beled for the treatment of for use—(A) Sows: 3 mg/lb BW anaplasmosis or anthrax, labeling shall intramuscularly once, approximately 8 also bear the following: ‘‘Federal law hours before farrowing or immediately restricts this drug to use by or on the after completion of farrowing, as an aid order of a licensed veterinarian.’’ in control of infectious enteritis (baby (e) Conditions of use—(1) Beef cattle, pig scours, colibacillosis) in suckling dairy cattle, and calves including pigs caused by E. coli.

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(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 cluding preruminating (veal) calves—(i) result in animal collapse. Oxytetra- Amounts and indications for use—(A) 3 to cycline should be administered intra- 5 mg per pound of bodyweight (mg/lb venously slowly over a period of at BW) per day (/day) intramuscularly, least 5 minutes. Discontinue treatment subcutaneously, or intravenously for at least 28 days prior to slaughter. Not treatment of pneumonia and shipping for use in lactating dairy animals. fever complex associated with (2) Swine—(i) Amounts and indications Pasteurella spp. and Histophilus spp., for use—(A) Sows: 3 mg/lb BW foot-rot and diphtheria caused by intramuscularly once, approximately 8 Fusobacterium necrophorum, bacterial hours before farrowing or immediately enteritis (scours) caused by Escherichia after completion of farrowing, as an aid coli, wooden tongue caused by in control of infectious enteritis (baby Actinobacillus lignieresii, leptospirosis pig scours, colibacillosis) in suckling caused by Leptospira pomona, wound in- pigs caused by E. coli. fections and acute metritis caused by (B) 3 to 5 mg/lb BW/day Staphylococcus spp. and Streptococcus intramuscularly for treatment of bac- spp. terial enteritis (scours, colibacillosis) (B) 5 mg/lb BW/day intramuscularly, caused by E. coli, pneumonia caused by subcutaneously, or intravenously for Pasteurella multocida, and leptospirosis treatment of severe foot-rot, and ad- caused by Leptospira pomona.

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(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. [68 FR 54805, Sept. 19, 2003. Redesignated and (iv) For use only in beef cattle, beef amended at 69 FR 31879, June 8, 2004; 73 FR calves, nonlactating dairy cattle, and 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). § 522.1662a Oxytetracycline hydro- (2) Sponsor. See 054628 in § 510.600(c) of chloride injection. this chapter. (a)(1) Specifications. The drug con- (3) Conditions of use—(i) Beef cattle tains 50 milligrams of oxytetracycline and nonlactating dairy cattle—(a) hydrochloride in each milliliter of ster- Amount. Three to 5 milligrams of oxy- ile solution. tetracycline per pound of body weight (2) Sponsor. See No. 054628 in per day; 5 milligrams per pound of body § 510.600(c) of this chapter. weight per day for the treatment of (3) Conditions of use. (i) The drug is anaplasmosis, severe foot-rot, and se- intended for use in beef cattle, beef vere cases of other indicated diseases. calves, nonlactating dairy cattle, and (b) Indications for use. Treatment of dairy calves for treatment of disease diseases due to oxytetracycline-suscep- conditions caused by one or more of tible organisms as follows: Pneumonia the following oxytetracycline sensitive and shipping fever complex associated pathogens listed as follows: pneumonia with Pasteurella spp., Hemophilus spp., and shipping fever complex (Pasteurella and Klebsiella spp., foot-rot and diph- spp.; Hemophilis spp.; Klebsiella spp. ), theria caused by Spherophorus bacterial enteritis (scours) (E. coli), necrophorus, bacterial enteritis (scours) foot-rot (Spherophorus necrophorus), caused by Escherichia coli, wooden diphtheria (Spherophorus necrophorus), tongue caused by Actinobacillus wooden tongue (Actinobacillus lignieresi, leptospirosis caused by lignieresi), leptospirosis (Leptospira po- Leptospira pomona, and wound infec- mona), and wound infections; acute me- tions and acute metritis caused by tritis; traumatic injury (caused by a Staphylococcus spp. and Streptococcus variety of bacterial organisms (such as spp. If labeled for use by or on the streptococcal and staphylococcal orga- order of a licensed veterinarian, it may nisms).) be used for the treatment of (ii) It is administered by anaplasmosis caused by Anaplasma intramuscular injection of 3 to 5 milli- marginale. grams of oxytetracycline hydro- (c) Limitations. For 50-milligram-per- chloride per pound of body weight per milliliter solution, administer day. Leptospirosis, severe foot-rot and intramuscularly or intravenously; for severe forms of the indicated diseases 100-milligram-per-milliliter solution, should be treated with 5 milligrams per administer intramuscularly only.

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

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(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 hours before farrowing or immediately no improvement is noted within 24 to after farrowing. 48 hours, diagnosis and therapy should (iii) In poultry (broilers, turkeys, and be reevaluated. breeding chickens) as follows: (v) When injecting intramuscularly (a) It is used for the treatment of air in adult livestock, do not inject more sacculitis (air-sac disease, chronic res- than 10 milliliters at any one site. The piratory disease) caused by Mycoplasma volume administered per injection site gallisepticum and Escherichia coli; fowl should be reduced according to age and cholera caused by Pasteurella multocida; body size so that 1 or 2 milliliters are infectious sinusitis caused by Myco- injected in smaller animals such as plasma gallisepticum; and infectious syn- small calves and young pigs. Intra- ovitis caused by Mycoplasma synoviae. venous administration is recommended (b) Administered subcutaneously to in cattle when daily dosage exceeds 50 chickens 1 day to 2 weeks of age at 6.25 milliliters. milligrams of oxytetracycline per bird (vi) Treatment must be discontinued per day diluted with 1 part of the drug at least 5 days prior to slaughter for to 3 parts of sterile water; to chickens chickens and turkeys and at least 22 2 to 4 weeks of age using the same di- days prior to slaughter for cattle and luted product at 12.5 milligrams of oxy- swine. When administered tetracycline per bird; to chickens 4 to 8 intramuscularly to animals within 30

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

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inject more than 10 milliliters per in- (ii) Indications for use. The drug is jection site intramuscularly in adult used for treatment of bacterial pneu- cattle; no more than 1 milliliter per monia and shipping fever complex asso- site in calves weighing 100 pounds or ciated with Pasteurella spp.; foot-rot less. Do not slaughter cattle for 13 days and calf diphtheria caused by after intramuscular or intravenous Spherophorus necrophorus; bacterial treatment, or 2 days after subcuta- enterities (scours) caused by Esch- neous treatment. Exceeding the high- erichia coli; wooden tongue caused by est recommended dosage or duration of Actinobacillus lignieresi; wound infec- treatment (not more than 4 consecu- tions, acute metrities, and traumatic tive days) may result in residues be- injury caused by staphylococcal and yond the withdrawal period. A with- streptococcal organisms. drawal period has not been established (iii) Limitations. Administer 50-milli- for use of this product in gram-per-milliliter solution preruminating calves. Do not use in intramuscularly; administer 100-milli- calves to be processed for veal. gram-per-milliliter solution intra- (ii) Swine—(a) Amount. 3 to 5 milli- venously. Continue treatment 24 to 48 grams of oxytetracycline per pound of hours following remission of disease body weight per day. Sows: Administer symptoms, not to exceed a total of 4 once 3 milligrams of oxytetracycline consecutive days. If no improvement is per pound of body weight, approxi- noted within 24 to 48 hours, consult a mately 8 hours before farrowing or im- veterinarian for diagnosis and therapy. mediately after completion of When injecting the drug farrowing. intramuscularly, do no inject more (b) Indications for use. For treatment than 10 milliliters per site in adult cat- of bacterial enteritis (scours, tle. Reduce the volume administered 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. noted within 24 hours, consult a veteri- (2) Sponsor. See No. 000859 in narian. Do not inject more than 5 mil- § 510.600(c) of this chapter. liliters per site. Discontinue treatment (3) Conditions of use—(i) Amount. The at least 20 days prior to slaughter. drug is used in beef cattle, beef calves, (h)(1) Specifications. Each milliliter of nonlactating dairy cattle, and dairy sterile solution contains 50 or 100 milli- calves as follows: Administer 3 to 5 grams of oxytetracycline hydro- milligrams of the oxytetracycline hy- chloride. drochloride intramuscularly per pound (2) Sponsors. See No. 054628 in of body weight per day. § 510.600(c) of this chapter for use of 50 (ii) Indications for use. The drug is and 100 milligrams per milliliter solu- used for treatment of bacterial pneu- tion; and Nos. 000859 and 055529 in monia and shipping fever complex asso- § 510.600(c) for use of 100 milligrams per ciated with Pasteurella spp.; foot-rot milliliter solution. and diptheria caused by Spherophorus (3) Conditions of use—(i) Amount. The necrophorus; bacterial enteritis (scours) drug is used in beef cattle, beef calves, caused by Escherichia coli; wooden nonlactating dairy cattle, and dairy tongue caused by Actinobacillus calves as follows: 3 to 5 milligrams of lignieresi; wound infections and acute oxytetracycline hydrochloride per metritis caused by staphylococcal and pound of body weight per day; 5 milli- streptococcal organisms susceptible to grams per pound of body weight per oxytetracycline. day for treatment of severe forms of (iii) Limitations. In severe forms of the indicated diseases. the indicated diseases, administer the

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equivalent of 5 milligrams of oxytetra- EDITORIAL NOTE: For FEDERAL REGISTER ci- cycline hydrochloride per pound of tations affecting § 522.1662a, see the List of body weight per day. Continue treat- CFR Sections Affected, which appears in the ment 24 to 48 hours following remission Finding Aids section of the printed volume and at www.fdsys.gov. of disease symptoms, not to exceed a total of 4 consecutive days. If no im- § 522.1662b Oxytetracycline hydro- provement is noted within 24 to 48 chloride with lidocaine injection. hours, consult a veterinarian for diagnosis and therapy. In adult livestock, (a) Specifications. The drug contains do not inject more than 10 milliliters 50 or 100 milligrams of oxytetracycline at any one site. Reduce the volume ad- hydrochloride and 2 percent lidocaine ministered per injection site according in each milliliter of sterile aqueous so- to age and body size. In calves weigh- lution. ing 100 pounds or less inject only 2 mil- (b) Sponsor. See No. 054771 in liliters per site. Discontinue treatment § 510.600(c) of this chapter. at least 18 days before slaughter. Not (c) Conditions of use. (1) The drug is for use in lactating dairy cattle. indicated for use in the treatment of (j) [Reserved] diseases of dogs caused by pathogens (k)(1) Specifications. Each milliliter of sensitive to oxytetracycline hydro- sterile solution contains either 50 or chloride including treatment for the 100 milligrams of oxytetracycline hy- following conditions in dogs caused by drochloride. susceptible microorganisms: Bacterial (2) Sponsor. See No. 061623 in infections of the urinary tract caused § 510.600(c) of this chapter. by Hemolytic staphylococcus, Strepto- (3) Conditions of use in beef cattle and coccus spp., Bacterial pulmonary infec- nonlactating dairy cattle—(i) Amount. 3 tions caused by Brucella bronchiseptica, to 5 milligrams per pound of body Streptococcus pyogenes, Staphylococcus weight daily, 5 milligrams per pound aureus, secondary bacterial infections for anaplasmosis, severe foot rot, and caused by Micrococcus pyogenes var. severe forms of other diseases. albus, Brucella bronchiseptica, Strepto- (ii) Indications for use. Treatment of coccus spp. diseases due to oxytetracycline-suscep- (2) The drug is administered tible organisms as follows: pneumonia intramuscularly at a recommended and shipping fever complex associated daily dosage to dogs at 5 milligrams with Pasteurella spp. and Hemophilus per pound of body weight administered spp.; foot rot and diphtheria caused by in divided doses at 6 to 12 hour inter- Fusobacterium necrophorum; bacterial vals. Therapy should be continued for enteritis (scours) caused by Escherichia at least 24 hours after all symptoms coli; wooden tongue caused by have subsided. Actinobacillus lignieresii; leptospirosis (3) Federal law restricts this drug to caused by Leptospira pomona; acute me- use by or on the order of a licensed vet- tritis and wound infections caused by erinarian. staphylococcal and streptococcal orga- [40 FR 13858, Mar. 27, 1975, as amended at 48 nisms; if labeled for use by or on the FR 30615, July 5, 1983; 79 FR 16192, Mar. 25, order of a licensed veterinarian, it may 2014] be used for treatment of anaplasmosis caused by Anaplasma marginale and an- § 522.1664 Oxytetracycline and thrax caused by Bacillus anthracis. flunixin. (iii) Limitations. Administer by intra- (a) Specifications. Each milliliter venous injection. Treatment should be (mL) of solution contains 300 milli- continued 24 to 48 hours following re- grams (mg) oxytetracycline base as mission of disease symptoms, but not amphoteric oxytetracycline and 20 mg to exceed a total of 4 consecutive days. flunixin base as flunixin meglumine. If no improvement occurs within 24 to (b) Sponsor. See No. 055529 in 48 hours, reevaluate diagnosis and ther- § 510.600(c) of this chapter. apy. Discontinue use at least 19 days (c) Related tolerances. See §§ 556.286 prior to slaughter. Not for use in lac- and 556.500 of this chapter. tating dairy cattle. (d) Conditions of use cattle—(1) [40 FR 13858, Mar. 27, 1975] Amount. Administer once as an

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intramuscular or subcutaneous injec- (2) Indications for use. Oxytocin may tion of 1 mL per 22 pounds (lb) body be used as a uterine contractor to pre- weight (BW) (13.6 mg oxytetracycline cipitate and accelerate normal parturi- and 0.9 mg flunixin per lb BW) where tion and postpartum evacuation of retreatment of calves and yearlings for uterine debris. In surgery it may be bacterial pneumonia is impractical due used postoperatively following cesar- to husbandry conditions, such as cattle ean section to facilitate involution and on range, or where their repeated re- resistance to the large inflow of blood. straint is inadvisable. It will contract smooth muscle cells of (2) Indications for use. For the treat- the mammary gland for milk letdown ment of bacterial pneumonia associ- if the udder is in proper physiological ated with Pasteurella spp. and for the state. control of associated pyrexia in beef (3) Limitations. Federal law restricts and nonlactating dairy cattle. this drug to use by or on the order of a (3) Limitations. Discontinue treat- licensed veterinarian. ment at least 21 days prior to slaughter of cattle. This drug product is not ap- [44 FR 63097, Nov. 2, 1979; 45 FR 1019, Jan. 4, 1980, as amended at 52 FR 18691, May 19, 1987; proved for use in female dairy cattle 20 52 FR 25212, July 6, 1987; 52 FR 36023, Sept. 25, months of age or older, including dry 1987; 53 FR 32610, Aug. 26, 1988; 53 FR 40728, dairy cows. Use in these cattle may Oct. 18, 1988; 54 FR 41442, Oct. 10, 1989; 55 FR cause drug residues in milk and/or in 8462, Mar. 8, 1990; 56 FR 14642, Apr. 11, 1991, 56 calves born to these cows. A with- FR 16002, Apr. 19, 1991; 59 FR 31139, June 17, drawal period has not been established 1994; 62 FR 35076, June 30, 1997; 62 FR 38906, in preruminating calves. Do not use in July 21, 1997; 65 FR 45877, July 26, 2000; 66 FR calves to be processed for veal. Federal 22117, May 3, 2001; 68 FR 36913, June 20, 2003; 77 FR 55414, Sept. 10, 2012; 78 FR 17597, Mar. law restricts this drug to use by or on 22, 2013; 78 FR 21060, Apr. 9, 2013; 79 FR 16192, the order of a licensed veterinarian. Mar. 25, 2014] [76 FR 3489, Jan. 20, 2011, as amended at 79 FR 16192, Mar. 25, 2014] § 522.1696 Penicillin G procaine injectable dosage forms. § 522.1680 Oxytocin. § 522.1696a Penicillin G benzathine (a) Specifications. Each milliliter and penicillin G procaine suspen- (mL) of solution contains 20 USP units sion. oxytocin. (a) Specifications. Each milliliter of (b) Sponsors. See Nos. , 000859, 054628, aqueous suspension contains penicillin 054771 and 061623 in § 510.600(c) of this G benzathine and penicillin G procaine, chapter. each equivalent to 150,000 units of peni- (c) Conditions of use—(1) Amount—(i) cillin G. Obstetrical. Administer drug intra- (b) Sponsors. See sponsors in venously, intramuscularly, or § 510.600(c) of this chapter for the condi- subcutaneously under aseptic conditions of use in paragraph (d) of this sections as indicated. The following dos- tion as follows: ages are recommended and may be re- (1) Nos. 054771, 055529, and 061623 for peated as conditions require: use as in paragraph (d)(1) of this sec- mL U.S.P. units tion. (2) Nos. 000859, 055529, and 061623 for Cats ...... 0.25 to 0.5 ...... 5 to 10. Dogs ...... 0.25 to 1.5 ...... 5 to 30. use as in paragraphs (d)(2)(i), Ewes, Sows ...... 1.5 to 2.5 ...... 30 to 50. (d)(2)(ii)(A), and (d)(2)(iii) of this sec- Cows, Horses ...... 5.0 ...... 100. tion. (3) No. 054771 for use as in paragraphs (ii) Milk letdown. Intravenous admin- (d)(2)(i), (d)(2)(ii)(B), and (d)(2)(iii) of istration is desirable. The following this section. dosage is recommended and may be re- (c) Related tolerances. See § 556.510 of peated as conditions require: this chapter. mL U.S.P. units (d) Conditions of use—(1) Horses, dogs, and beef cattle—(i) Amount—(A) Beef Cows ...... 0.5 to 1.0 ...... 10 to 20. cattle. 2 milliliters per 150 pounds of Sows ...... 0.25 to 1.0 ...... 5 to 20. body weight intramuscularly or

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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. (ii) Conditions of use. Treatment of (iii) Limitations. Federal law restricts bacterial infections susceptible to peni- this drug to use by or on the order of a cillin G. licensed veterinarian. (iii) Limitations. Not for use in beef cattle within 30 days of slaughter. Do (2) Cattle, sheep, swine, and horses—(i) not use in horses intended for human Amount. 3,000 units per pound body consumption. Federal law restricts this weight (1 milliliter per 100 pounds body drug to use by or on the order of a li- weight) daily by intramuscular injec- censed veterinarian. tion. (2) Beef cattle—(i) Amount. 2 milli- (A) For Nos. 000859, 054771, 055529, and liters per 150 pounds of body weight 061623: Continue treatment at least 48 subcutaneously. Repeat dosage in 48 hours after symptoms disappear. hours. (B) For No. 055529: Continue treat- (ii) Conditions of use. ment at least 1 day after symptoms (A) Treatment of bacterial pneu- disappear (usually 2 or 3 days). monia (Streptococcus spp., Actinomyces (ii) Indications for use. Treatment of pyogenes, Staphylococcus aureus); upper cattle and sheep for bacterial pneu- respiratory infections such as rhinitis monia (shipping fever) caused by or pharyngitis (A. pyogenes); blackleg Pasteurella multocida; swine for erysipe- (Clostridium chauvoei). las caused by Erysipelothrix (B) As in paragraph (d)(2)(ii)(A) of rhusiopathiae; and horses for strangles this section; and prophylaxis of bovine caused by Streptococcus equi. shipping fever in 300- to 500-pound beef (iii) Not for use in horses calves. Limitations. (iii) Limitations. Not for use within 30 intended for food. Milk that has been days of slaughter. For Nos. 000859, taken during treatment and for 48 055529, and 061623: A withdrawal period hours after the last treatment must has not been established for this prod- not be used for food. uct in pre-ruminating calves. Do not (A) For Nos. 054771 and 061623: Do not use in calves to be processed for veal. exceed 7 days of treatment in nonlactating dairy and beef cattle, sheep, and [66 FR 711, Jan. 4, 2001, as amended at 68 FR 34534, June 10, 2003; 70 FR 21947, Apr. 28, 2005; swine, or 5 days in lactating cattle. 70 FR 50182, Aug. 26, 2005; 73 FR 16754, Mar. Discontinue treatment for the fol- 31, 2008; 75 FR 54017, Sept. 3, 2010; 77 FR 4897, lowing number of days before slaugh- Feb. 1, 2012; 78 FR 17597, Mar. 22, 2013; 79 FR ter: Nonruminating cattle (calves)—7; 16192, Mar. 25, 2014] all other cattle—4; sheep—8; and swine—6. § 522.1696b Penicillin G procaine aqueous suspension. (B) For Nos. 000859 and 055529: Con- tinue treatment at least 1 day after (a) Specifications. Each milliliter con- symptoms disappear (usually 2 or 3 tains penicillin G procaine equivalent days). to 300,000 units of penicillin G. (b) Sponsors. See sponsor numbers in [66 FR 712, Jan. 4, 2001, as amended at 68 FR § 510.600(c) of this chapter as follows: 34534, June 10, 2003; 68 FR 42589, July 18, 2003; (1) Nos. 000859, 054771, and 055529 for 69 FR 17586, Apr. 5, 2004; 70 FR 16935, Apr. 4, use as in paragraph (d) of this section. 2005; 73 FR 14177, Mar. 17, 2008; 75 FR 54017, (2) No. 061623 for use as in paragraph Sept. 3, 2010; 78 FR 17597, Mar. 22, 2013; 79 FR (d)(2) of this section. 16192, Mar. 25, 2014] (c) Related tolerances. See § 556.510 of this chapter.

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§ 522.1696c Penicillin G procaine in (iii) Limitations. Federal law restricts oil. this drug to use by or on the order of a licensed veterinarian. (a) Specifications. Each milliliter contains penicillin G procaine equivalent [42 FR 31450, June 21, 1977, as amended at 42 to 300,000 units of penicillin G. FR 36995, July 19, 1977; 47 FR 5409, Feb. 5, 1982; 55 FR 23076, June 6, 1990; 79 FR 16193, (b) Sponsor. See No. 054771 in Mar. 25, 2014] § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Dogs § 522.1704 Pentobarbital. and cats—10,000 units per pound of body (a) Specifications. Each milliliter of weight once daily. Horses—3,000 units solution contains 64.8 milligrams (mg) per pound of body weight once daily. of sodium pentobarbital. (2) Indications for use. Treatment of (b) Sponsor. See No. 000061 in infections of dogs, cats, and horses § 510.600(c) of this chapter. caused by penicillin-susceptible orga- (c) Conditions of use—(1) Amount. The nisms such as Streptococci, drug is administered intravenously ‘‘to Staphylococci, and Corynebacteria. effect’’. For general surgical anes- (3) Limitations. Not for use in food- thesia, the usual dose is 11 to 13 mg per producing animals. Federal law re- pound of body weight. For sedation, stricts this drug to use by or on the the usual dose is approximately 2 mg order of a licensed veterinarian. per pound of body weight. For relieving convulsive seizures caused by strych- [57 FR 37333, Aug. 18, 1992, as amended at 79 nine in dogs, the injection should be FR 16193, Mar. 25, 2014] administered intravenously ‘‘to effect’’. The drug may be administered § 522.1698 Pentazocine. intraperitoneally. When given (a) Specifications. Each milliliter of intraperitoneally, it is administered at solution contains pentazocine lactate the same dosage level as for intra- equivalent to 30 milligrams (mg) of venous administration. (2) The drug is in- pentazocine base. Indications for use. dicated for use as a general anesthetic (b) Sponsor. See No. 054771 in in dogs and cats. Although it may be § 510.600(c) of this chapter. used as a general surgical anesthetic (c) Conditions of use—(1) Horses—(i) for horses, it is usually given at a Amount. Administer 0.15 mg lower dose to cause sedation and hyp- pentazocine base per pound of body nosis and may be supplemented with a weight daily by intravenous or local anesthetic. It may also be used in intramuscular injection. In cases of se- dogs for the symptomatic treatment of vere pain, a second dose is rec- strychnine poisoning. ommended by intramuscular injection (3) Limitations. Do not use in horses 10 to 15 minutes after the initial dose intended for human consumption. Fed- at the same level. eral law restricts this drug to use by or (ii) Indications for use. For sympto- on the order of a licensed veterinarian. matic relief of pain due to colic. [79 FR 16193, Mar. 25, 2014] (iii) Limitations. Do not use in horses intended for human consumption. Fed- § 522.1720 Phenylbutazone. eral law restricts this drug to use by or (a) Specifications—(1) Each milliliter on the order of a licensed veterinarian. of solution contains 100 milligrams (2) Dogs—(i) Amount. Administer 0.75 (mg) of phenylbutazone. to 1.50 mg of pentazocine base per (2) Each milliliter of solution con- pound of body weight by intramuscular tains 200 mg of phenylbutazone. injection. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use as in (ii) Indications for use. For ameliora- paragraph (c) of this section: tion of pain accompanying post- (1) No. 054771 for use of product de- operative recovery, fracture, trauma, scribed in paragraph (a)(1) as in para- and spinal disorders. graph (c) of this section. (2) Nos. 000061, 000859, 054771, and 061623 for use of product described in

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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 ofuse—(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 (iii) Limitations. Federal law restricts contains 100 mg polysulfated this drug to use by or on the order of a glycosaminoglycan. licensed veterinarian. (b) Sponsor. See No. 010797 in (2) Horses—(i) Amount. Administer by § 510.600(c) of this chapter. intravenous injection 1 to 2 grams (g) (c) Special considerations. Federal law per 1,000 pounds of body weight daily in restricts this drug to use by or on the three divided doses, not to exceed 4 g order of a licensed veterinarian. daily. Limit intravenous administra- (d) Conditions of use—(1) Horses—(i) tion to not more than 5 successive Indications for use. For the treatment of days. noninfectious degenerative and/or trau- (ii) Indications for use. For the relief matic joint dysfunction and associated of inflammatory conditions associated lameness of the carpal and hock joints with the musculoskeletal system. in horses. (iii) Limitations. Do not use in horses (ii) Amount—(A) Intra-articular use intended for human consumption. Fed- (carpal): 250 mg once a week for 5 eral law restricts this drug to use by or weeks. on the order of a licensed veterinarian. (B) Intramuscular use (carpal and [79 FR 16193, Mar. 25, 2014] hock): 500 mg every 4 days for 28 days. (iii) Limitations. Do not use in horses § 522.1820 Pituitary luteinizing hor- intended for human consumption. mone powder for injection. (2) Dogs—(i) Indications for use. For (a) Specifications. The drug is a control of signs associated with non- lyophilized pituitary extract. Each 6- infectious degenerative and/or trau- milliliter vial contains an amount matic arthritis of canine synovial equivalent to 25 milligrams of standard joints. pituitary luteinizing hormone and is (ii) Amount. 2 mg per pound of body reconstituted for use by addition of 5 weight by intramuscular injection milliliters of 0.9 percent aqueous so- twice weekly for up to 4 weeks (max- dium chloride solution. imum of 8 injections). (b) Sponsor. No. 000061 in § 510.600(c) of [72 FR 56896, Oct. 5, 2007, as amended at 74 FR this chapter. 67816, Dec. 21, 2009] (c) Conditions of use—(1) Amount. Cat- tle and horses: 25 milligrams; swine: 5 § 522.1862 Pralidoxime powder for in- milligrams; sheep: 2.5 milligrams; and jection. dogs: 1.0 milligram. Preferably given (a) Specifications. Each vial contains 1 by intravenous injection, it may be ad- gram (g) of pralidoxime chloride pow- ministered subcutaneously. Treatment der for mixing with 20 cubic centi- may be repeated in 1 to 4 weeks, or as meters of sterile water for injection. indicated. Each milliliter of constituted solution (2) Indications for use. As an aid in the contains 50 milligrams (mg) treatment of breeding disorders related pralidoxime chloride.

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(b) Sponsor. See No. 054771 in canine cestode Echinococcus § 510.600(c) of this chapter. multilocularis. (c) Conditions of use—(1) Amount. Ad- (iii) Limitations. Federal law restricts minister as soon as possible after expo- this drug to use by or on the order of a sure to the poison. Before administra- licensed veterinarian. tion of the sterile pralidoxime chloride, (2) Cats—(i) Amount. For cats under 5 atropine is administered intravenously pounds, 0.2 milliliter (11.4 milligrams); at a dosage rate of 0.05 mg per pound of 5 to 10 pounds, 0.4 milliliter (22.7 milli- body weight, followed by administra- grams); 11 pounds and over, 0.6 milli- tion of an additional 0.15 mg of atro- liter (34.1 milligrams) maximum. pine per pound of body weight adminis- (ii) For removal of tered intramuscularly. Then the appro- Indications for use. priate dosage of sterile pralidoxime feline cestodes Dipylidium caninum and chloride is administered slowly intra- Taenia taeniaeformis. venously. The dosage rate for sterile (iii) Limitations. Federal law restricts pralidoxime chloride when adminis- this drug to use by or on the order of a tered to horses is 2 g per horse. When licensed veterinarian. administered to dogs and cats, it is 25 [46 FR 10464, Feb. 3, 1981, as amended at 47 mg per pound of body weight. For FR 6617, Feb. 16, 1982; 58 FR 42853, Aug. 12, small dogs and cats, sterile 1993; 67 FR 79853, Dec. 31, 2002; 78 FR 17868, pralidoxime chloride may be adminis- Mar. 25, 2013] tered either intraperitoneally or intramuscularly. A mild degree of § 522.1881 Prednisolone acetate. atropinization should be maintained (a) Specifications. Each milliliter of for at least 48 hours. Following severe suspension contains 25 milligrams (mg) poisoning, a second dose of sterile of prednisolone acetate. pralidoxime chloride may be given after 1 hour if muscle weakness has not (b) Sponsor. See No. 000061 in been relieved. § 510.600(c) of this chapter. (2) Indications for use. It is used in (c) Conditions of use—(1) Amount. The horses, dogs, and cats as an antidote in drug is administered to horses intra- the treatment of poisoning due to articularly at a dosage level of 50 to 100 those pesticides and chemicals of the mg. The dose may be repeated when organophosphate class which have necessary. The drug is administered to anticholinesterase activity in horses, dogs and cats intramuscularly at a dos- dogs, and cats. age level of 10 to 50 mg. The dosage (3) Limitations. Federal law restricts may be repeated when necessary. If the this drug to use by or on the order of a condition is of a chronic nature, an licensed veterinarian. oral corticosteroid may be given as a [79 FR 16193, Mar. 25, 2014] maintenance dosage. The drug may be given intra-articularly to dogs and cats § 522.1870 Praziquantel. at a dosage level of 5 to 25 mg. The dose (a) Specification. Each milliliter con- may be repeated when necessary after 7 tains 56.8 milligrams of praziquantel. days for two or three doses. (b) Sponsors. See Nos. 000859 and (2) Indications for use. The drug is in- 061623 in § 510.600(c) of this chapter. dicated in the treatment of dogs, cats, (c) Conditions of use—(1) Dogs—(i) and horses for conditions requiring an Amount. For dogs 5 pounds and under, anti-inflammatory agent. The drug is 0.3 milliliter (17.0 milligrams); for 6 to indicated for the treatment of acute 10 pounds, 0.5 milliliter (28.4 milli- musculoskeletal inflammations such as grams); for 11 to 25 pounds, 1.0 milli- bursitis, carpitis, and spondylitis. The liter (56.8 milligrams); if over 25 drug is indicated as supportive therapy Pounds, 0.2 milliliter (11.4 milligrams) in nonspecific dermatosis such as sum- per 5 pounds body weight to a max- mer eczema and atopy. The drug may imum of 3 milliliters (170.4 milligrams). be used as supportive therapy pre- and (ii) Indications for use. For removal of postoperatively and for various stress canine cestodes Dipylidium caninum, conditions when corticosteroids are re- Taenia pisiformis, and Echinococcus quired while the animal is being treat- granulosus, and removal and control of ed for a specific condition.

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(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, [79 FR 16194, Mar. 25, 2014] 6, or 10 hour intervals, as determined by the condition of the animal, for § 522.1883 Prednisolone sodium phos- treatment of shock. phate. (iii) Dogs and cats. Administer by (a) Specifications. Each milliliter of intramuscular injection for treatment solution contains 20 milligrams (mg) of inflammatory, allergic, and less se- prednisolone sodium phosphate (equiv- vere stress conditions, where imme- alent to 14.88 mg of prednisolone). diate effect is not required, at 1 to 5 mg (b) Sponsor. See No. 061623 in ranging upward to 30 to 50 mg in large § 510.600(c) of this chapter. breeds of dogs. Dosage may be repeated (c) Conditions of use in dogs—(1) in 12 to 24 hours and continued for 3 to Amount. Administer intravenously in a 5 days if necessary. If permanent dosage of 21⁄2 to 5 mg per pound of body corticosteroid effect is required, oral weight, initially for shock and shock- therapy with prednisolone tablets may like states, followed by equal mainte- be substituted. nance doses at 1-, 3-, 6-, or 10-hour in- (2) Limitations. Do not use in horses tervals as determined by the condition intended for human consumption. Fed- of the animal. eral law restricts this drug to use by or (2) Indications for use. Administer on the order of a licensed veterinarian. when a rapid adrenal glucocorticoid and/or anti-inflammatory effect is nec- [79 FR 16194, Mar. 25, 2014] essary. (3) Limitations. Federal law restricts § 522.1885 Prednisolone tertiary this drug to use by or on the order of a butylacetate. licensed veterinarian. (a) Specifications. Each milliliter of [68 FR 59881, Oct. 20, 2003] suspension contains 20 milligrams (mg) of prednisolone tertiary butylacetate. § 522.1884 Prednisolone sodium succi- (b) Sponsor. See No. 050604 in nate. § 510.600(c) of this chapter. (a) Specifications. Each milliliter of (c) Conditions of use—(1) Amount—(i) prednisolone sodium succinate injec- Horses: Administer by intramuscular tion contains: Prednisolone sodium injection 100 to 300 mg or by succinate equivalent in activity to 10, intrasynovial injection at a dosage 20, or 50 milligrams (mg) of prednis- level of 50 to 100 mg. Retreatment of olone. horses in 24 to 48 hours may be nec- (b) Sponsor. See No. 054771 in essary, depending on the general condi- § 510.600(c) of this chapter for products tion of the animal and the severity and containing 10, 20, and 50 mg equivalent duration of the disease. prednisolone activity per milliliter for use in horses, dogs, and cats as pro- (ii) Dogs and cats: Administer by vided in paragraphs (c)(1)(i), (ii), and intramuscular injection 1 mg per 5 (iii) of this section. pounds of body weight or (c) Conditions of use—(1) Amount and intrasynovially at a dosage level of 10 indications for use—(i) Horses. Admin- to 20 mg. ister 50 to 100 mg as an initial dose by (2) Indications for use. It is used as an intravenous injection over a period of anti-inflammatory agent in horses, one-half to 1 minute, or by dogs, and cats. intramuscular injection, and may be (3) Limitations. Do not use in horses repeated in inflammatory, allergic, or intended for human consumption. Fed- other stress conditions at intervals of eral law restricts this drug to use by or 12, 24, or 48 hours, depending upon the on the order of a licensed veterinarian. size of the animal, the severity of the condition and the response to treat- [79 FR 16194, Mar. 25, 2014] ment.

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§ 522.1890 Sterile prednisone suspen- (3) Limitations. Federal law restricts sion. this drug to use by or on the order of a licensed veterinarian. (a) Specifications. Each milliliter of suspension contains 10 to 40 milligrams [79 FR 16194, Mar. 25, 2014] (mg) of prednisone. (b) Sponsor. See No. 000061 in § 522.1940 Progesterone and estradiol § 510.600(c) of this chapter. benzoate. (c) Conditions of use—(1) Amount—(i) (a) Sponsors. See sponsors in Horses. Administer 100 to 400 mg by § 510.600(c) of this chapter for use as in intramuscular injection, repeating if paragraph (c) of this section: necessary. (1) No. 054771 for use as in paragraphs (ii) Dogs and cats. Administer 0.25 to (c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), 1.0 mg per pound of body weight by (c)(2)(i)(A), (c)(2)(ii), (c)(2)(iii), and intramuscular injection for 3 to 5 days (c)(3) of this section. or until a response is noted. Treatment (2) No. 000986 for use as in paragraphs may be continued with an orally ad- (c)(1) and (c)(2) of this section. ministered dose. (b) Related tolerances. See §§ 556.240 and 556.540 of this chapter. (2) Indications for use. It is used for (c) Conditions of use in cattle. It is conditions requiring an anti-inflam- used for implantation as follows: matory agent. (1) Suckling beef calves—(i) Amount— (3) Limitations. Do not use in horses (A) 100 milligrams (mg) progesterone intended for human consumption. Fed- and 10 mg estradiol benzoate (one im- eral law restricts this drug to use by or plant consisting of 4 pellets, each pel- on the order of a licensed veterinarian. let containing 25 mg progesterone and [79 FR 16194, Mar. 25, 2014] 2.5 mg estradiol benzoate) per implant dose. § 522.1920 Prochlorperazine and (B) 100 mg progesterone and 10 mg es- isopropamide. tradiol benzoate (one implant con- (a) Specifications. Each milliliter of sisting of 5 pellets, each of 4 pellets solution contains prochlorperazine containing 25 mg progesterone and 2.5 edisylate equivalent to 4 milligrams mg estradiol benzoate, and 1 pellet con- (mg) prochlorperazine and taining 29 mg tylosin tartrate) per im- isopropamide iodide equivalent to 0.28 plant dose. mg of isopropamide. (ii) Indications for use. For increased rate of weight gain. (b) Sponsor. See No. 054771 in (iii) For use in suckling § 510.600(c) of this chapter. Limitations. beef calves (at least 45 days of age) up (c) Conditions of use—(1) Amount. (i) to 400 pounds (lb) of body weight. For Dosage is administered by subcuta- subcutaneous ear implantation, one neous injection twice daily as follows: dose per animal. Do not use in bull Dosage in calves intended for reproduction. Safe- Weight of animal in pounds milliliters ty and effectiveness have not been established in veal calves. A withdrawal Up to 4 ...... 0.25 period has not been established for this 5 to 14 ...... 0.5–1 15 to 30 ...... 2–3 product in preruminating calves. Do 30 to 45 ...... 3–4 not use in calves to be processed for 45 to 60 ...... 4–5 veal. Over 60 ...... 6 (2) Steers—(i) Amount—(A) 200 mg progesterone and 20 mg estradiol benzoate (ii) Following the last injection, ad- (one implant consisting of 8 pellets, minister prochlorperazine and each pellet containing 25 mg progester- isopropamide sustained release cap- one and 2.5 mg estradiol benzoate) per sules as indicated. implant dose. (2) Indications for use. For use in dogs (B) 200 mg progesterone and 20 mg es- and cats in which gastrointestinal dis- tradiol benzoate (one implant con- turbances are associated with emo- sisting of 9 pellets, each of 8 pellets tional stress. containing 25 mg progesterone and 2.5

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mg estradiol benzoate, and 1 pellet con- tion with local anesthesia; and as ad- taining 29 mg tylosin tartrate) per im- junctive therapy for tetanus. plant dose. (B) For use as a tranquilizer and (ii) Indications for use. For increased preanesthetic. rate of weight gain and improved feed (iii) Limitations. Do not use in horses efficiency. intended for human consumption. Fed- (iii) Limitations. For animals weigh- eral law restricts this drug to use by or ing 400 lb or more; for subcutaneous ear on the order of a licensed veterinarian. implantation, one dose per animal. (2) Dogs and cats—(i) Amount. 1 to 2 Safety and effectiveness have not been mg/lb body weight intramuscularly or established in veal calves. A with- intravenously every 4 to 6 hours. drawal period has not been established (ii) Indications for use. For use as a for this product in preruminating tranquilizer, preanesthetic, for minor calves. Do not use in calves to be proc- operative procedures in conjunction essed for veal. with local anesthesia, as adjunctive (3) Steers fed in confinement for slaugh- therapy for tetanus, and as an ter—(i) Amount. Reimplant 200 mg pro- antiemetic prior to worming; or to pre- gesterone and 20 mg estradiol benzoate vent motion sickness in dogs. on approximately day 70 following an (iii) Limitations. Federal law restricts initial implant of 100 mg progesterone this drug to use by or on the order of a and 10 mg estradiol benzoate or 200 mg licensed veterinarian. progesterone and 20 mg estradiol benzoate. [46 FR 18962, Mar. 27, 1981, as amended at 68 (ii) Indications for use. For additional FR 59881, Oct. 20, 2003; 70 FR 50183, Aug. 26, improvement in rate of weight gain. 2005; 79 FR 16194, Mar. 25, 2014] (iii) Limitations. For subcutaneous ear implantation. Safety and effectiveness § 522.2002 Propiopromazine. have not been established in veal (a) Specifications. Each milliliter of calves. A withdrawal period has not solution contains 5 or 10 milligrams been established for this product in (mg) propiopromazine hydrochloride. preruminating calves. Do not use in (b) Sponsor. See No. 054771 in calves to be processed for veal. § 510.600(c) of this chapter. [69 FR 70055, Dec. 2, 2004, as amended at 77 (c) Conditions of use in dogs and cats— FR 31723, May 30, 2012; 79 FR 16194, Mar. 25, (1) Amounts and indications for use. Ad- 2014] minister 0.05 to 0.5 mg per pound of body weight by intravenous or § 522.1962 Promazine. intramuscular injection for (a) Specifications. Each milliliter of tranquilization. Administer 0.25 mg per solution contains 50 milligrams (mg) pound of body weight by intravenous promazine hydrochloride. injection as a preanesthetic. (b) Sponsors. See sponsors in (2) Limitations. Federal law restricts § 510.600(c) of this chapter for use as in this drug to use by or on the order of a paragraph (c) of this section: licensed veterinarian. (1) No. 054771 for use as in paragraphs [79 FR 16195, Mar. 25, 2014] (c)(1)(i)(A), (c)(1)(ii)(A), (c)(1)(iii), and (c)(2) of this section. § 522.2005 Propofol. (2) No. 061623 for use as in paragraphs (c)(1)(i)(B), (c)(1)(ii)(B), and (c)(1)(iii) of (a) Specifications. Each milliliter of this section. emulsion contains 10 milligrams (mg) (c) Conditions of use—(1) Horses—(i) propofol. Amount—(A) 0.2 to 0.5 milligrams per (b) Sponsors. See sponsor numbers in pounds (mg/lb) body weight § 510.600(c) of this chapter. intramuscularly or intravenously (1) No. 000859 for use as in paragraphs every 4 to 6 hours. (c)(1), (c)(2)(i), and (c)(3) of this section. (B) 0.2 to 0.5 mg/lb body weight intra- (2) No. 000044 for use as in paragraphs venously as required. (c)(1), (c)(2)(i), and (c)(3) of this section. (ii) Indications for use—(A) For use as (3) No. 054771 for use as in paragraphs a tranquilizer, preanesthetic, or for (c)(1), (c)(2)(ii), and (c)(3) of this sec- minor operative procedures in conjunction.

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(c) Conditions of use in dogs and cats— Dosage may be repeated every 6 to 12 (1) Amount. Administer by intravenous hours whenever necessary. injection according to label directions. (ii) Horses, 40 to 60 mg/100 lbs body The use of preanesthetic medication weight; foals, 20 mg/100 lbs body reduces propofol dose requirements. weight. Administer by slow intra- (2) Indications for use—(i) As a single venous injection. Dosage may be re- injection to provide general anesthesia peated every 6 to 12 hours if necessary. for short procedures; for induction and (2) Indications for use. It is intended maintenance of general anesthesia for treating horses in conditions in using incremental doses to effect; for which antihistaminic therapy may be induction of general anesthesia where expected to lead to alleviation of some maintenance is provided by inhalant signs of disease. anesthetics. (3) Limitations. Do not use in horses (ii) For the induction and mainte- intended for human consumption. Fed- nance of anesthesia and for induction eral law restricts this drug to use by or of anesthesia followed by maintenance on the order of a licensed veterinarian. with an inhalant anesthetic. [79 FR 16195, Mar. 25, 2014] (3) Limitations. Federal law restricts this drug to use by or on the order of a § 522.2076 Romifidine. licensed veterinarian. (a) Specifications. Each milliliter of [75 FR 20269, Apr. 19, 2010, as amended at 75 solution contains 10 milligrams (mg) FR 38700, July 6, 2010; 78 FR 17868, Mar. 25, romifidine hydrochloride. 2013; 79 FR 16195, Mar. 25, 2014] (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. § 522.2012 Prostalene. (c) Conditions of use in horses—(1) (a) Specifications. Each milliliter of Amount. 40 to 120 micrograms per kilo- solution contains 1 milligram of gram of body weight (mcg/kg BW) in- prostalene. travenously for sedation and analgesia; (b) Sponsor. No. 054771 in § 510.600(c) of 100 mcg/kg BW intravenously as a this chapter. preanesthetic. (c) Conditions of use in horses—(1) (2) Indications for use. For use as a Amount. Administer 5 micrograms per sedative and analgesic to facilitate kilogram of body weight as a single handling, clinical examinations, clin- subcutaneous injection. ical procedures, and minor surgical (2) Indications for use. For the control procedures in adult horses; and for use of estrus in mares. as a preanesthetic prior to the induc- (3) Limitations. Do not use in horses tion of general anesthesia in adult intended for human consumption. Fed- horses. eral law restricts this drug to use by or (3) Limitations. Do not use in horses on the order of a licensed veterinarian. intended for human consumption. Fed- [79 FR 16195, Mar. 25, 2014] eral law restricts this drug to use by or on the order of a licensed veterinarian. § 522.2063 Pyrilamine. [69 FR 47363, Aug. 5, 2004, as amended at 79 (a) Specifications. Each milliliter of FR 16195, Mar. 25, 2014] solution contains 20 milligrams (mg) of pyrilamine maleate. § 522.2100 Selenium and vitamin E. (b) Sponsors. See sponsor numbers in (a)(1) Specifications. Each milliliter of § 510.600(c) of this chapter for uses in emulsion contains 5.48 milligrams (mg) paragraph (c) of this section. sodium selenite (equivalent to 2.5 mg (1) No. 000061 for use as in paragraph selenium) and 50 mg of vitamin E (68 (c)(1)(i), (2), and (3) of this section. I.U.) (as d-alpha tocopheryl acetate). (2) No. 061623 for use as in paragraph (2) Sponsor. See No. 000061 in (c)(1)(ii), (2), and (3) of this section. § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount—(i) (3) Conditions of use in horses—(i) Horses, 40 to 60 mg per 100 pounds (lbs) Amount. Administer 1 milliliter (mL) body weight; foals, 20 mg/100 lbs body per (/) 100 pounds (lbs) of body weight weight. Administer by intramuscular, by intravenous injection or by deep subcutaneous, or intravenous injection. intramuscular injection in divided

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doses in two or more sites in the glu- milliliter per 40 pounds, minimum 1 teal or cervical muscles. Administra- milliliter. tion may be repeated at 5 to 10 day in- (ii) Indications for use. Calves, lambs, tervals. and ewes: prevention and treatment of (ii) Indications for use. For the pre- white muscle disease (selenium-tocoph- vention and treatment of selenium-to- erol deficiency syndrome). Sows and copherol deficiency syndrome in weanling pigs: an aid in the prevention horses. and treatment of selenium-tocopherol (iii) Limitations. Do not use in horses deficiency. intended for human consumption. Fed- (iii) Limitations. For subcutaneous or eral law restricts this drug to use by or intramuscular use. Not for use in new- on the order of a licensed veterinarian. born pigs. Do not use in pregnant ewes. (b)(1) Specifications. Each milliliter Calves: Discontinue use 30 days before contains 2.19 mg of sodium selenite treated calves are slaughtered for (equivalent to 1 mg of selenium), 50 mg human consumption. Lambs, ewes, of vitamin E (68 I.U.) (as d-alpha sows, or pigs: Discontinue use 14 days tocopheryl acetate). before treated lambs, ewes, sows, or pigs are slaughtered for human con- (2) Sponsor. See No. 000061 in sumption. Federal law restricts this § 510.600(c) of this chapter. drug to use by or on the order of a li- (3) Conditions of use in dogs—(i) censed veterinarian. Administer by subcutaneous Amount. (d)(1) Specifications. Each milliliter or intramuscular injection in divided contains 10.95 milligrams selenite so- doses in two or more sites at 1 mL/20 dium (equivalent to 5 milligrams sele- lbs of body weight with a minimum nium), 50 milligrams vitamin E (68 1⁄4 mL and a maximum dosage dosage of U.S.P. units). of 5 mL. The dose is repeated at 3-day (2) Sponsors. See Nos. 000061 and 054771 intervals until a satisfactory thera- in § 510.600(c) of this chapter. peutic response is observed. A mainte- (3) Conditions of use—(i) Dosage. nance regimen is then initiated which Breeding beef cows: 1 milliliter per 200 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) Conditions of use—(i) 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

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syndrome). Baby pigs: an aid in the § 522.2120 Spectinomycin prevention and treatment of selenium- dihydrochloride injection. tocopherol deficiency. (a) Specifications. The spectinomycin (iii) Limitations. For subcutaneous or dihydrochloride pentahydrate used in intramuscular use only. Discontinue manufacturing the drug is the anti- use 14 days before treated animals are biotic substance produced by the slaughtered for human consumption. growth of Streptomyces flavopersicus Federal law restricts this drug to use (var. Abbott) or the same antibiotic by or on the order of a licensed veteri- substance produced by any other narian. means. Each milliliter of the drug con- [40 FR 13858, Mar. 27, 1975, as amended at 52 tains the following amount of FR 7832, Mar. 13, 1987; 57 FR 21209, May 19, spectinomycin activity from 1992; 58 FR 57556, Oct. 26, 1993; 60 FR 57833, spectinomycin dihydrochloride Nov. 22, 1995; 64 FR 27916, May 24, 1999; 79 FR pentahydrate: 16195, Mar. 25, 2014] (1) 5 milligrams when used as provided in paragraph (d)(1) of this sec- § 522.2112 Sometribove zinc suspen- tion. sion. (2) [Reserved] (a) Specifications. Each single-dose sy- (3) 100 milligrams when used as pro- ringe contains 500 milligrams (mg) vided in paragraphs (d) (2), (3), and (4) sometribove zinc in a prolonged-release of this section. suspension. (b) Sponsor. In § 510.600 of this chap- (b) Sponsor. See No. 000986 in ter, see No. 000859 for conditions of use § 510.600(c) of this chapter. as in paragraph (d) of this section, and (c) Conditions of use—(1) Amount. In- see No. 054771 for conditions of use as ject 500 mg every 14 days starting dur- in paragraph (d)(2) and (d)(4) of this ing the 9th or 10th week (57 to 70 days) section. after calving and continue until the (c) Special considerations. The quan- end of lactation. tity of spectinomycin referred to in (2) Indications for use. To increase this section refers to the equivalent production of marketable milk in weight of base activity for the drug. healthy lactating dairy cows. (d) Conditions of use. It is adminis- (3) Limitations. Use in lactating dairy tered as spectinomycin dihydrochloride cows only. Safety to replacement bulls pentahydrate as follows: born to treated dairy cows has not been (1) Subcutaneously in the treatment established. Inject subcutaneously. of 1-to-3-day-old turkey poults at the Avoid injections within 2 weeks of ex- rate of 1 to 2 milligrams per poult as an pected slaughter to minimize injection aid in the prevention of mortality asso- site blemishes on carcass. There is no ciated with Arizona group infection. milk discard or preslaughter with- (2) Subcutaneously in the treatment drawal period. Use may reduce preg- of 1-to-3-day old: nancy rates and increase days open. (i) Turkey poults at the rate of 5 mil- Treated cows are at an increased risk ligrams per poult as an aid in the con- for mastitis and higher milk somatic trol of chronic respiratory disease cell counts. Use care to differentiate (CRD) associated with E. coli. increased body temperature due to use (ii) Baby chicks at the rate of 2.5 to of this product from an increased body 5 milligrams per chick as an aid in the temperature that may occur due to ill- control of mortality and to lessen se- ness. Cows treated with this product verity of infections caused by M. may have more enlarged hocks and dis- synoviae, S. typhimurium, S. infantis, orders of the foot region. Use may re- and E. coli. duce hemoglobin and hematocrit val- (3) Intramuscularly in the treatment ues during treatment. Human warning: of dogs: Avoid prolonged or repeated contact (i) At a dosage level of 2.5 milligrams with eyes and skin. to 5.0 milligrams per pound of body [58 FR 59947, Nov. 12, 1993, as amended at 67 weight twice daily. Treatment may be FR 18085, Apr. 15, 2002; 68 FR 62006, Oct. 31, continued for 4 days. For treatment of 2003; 74 FR 53164, Oct. 16, 2009] infections caused by gram-negative and

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gram-positive organisms susceptible to breeds of dogs: 25 mg. For larger dogs: spectinomycin. 50 mg. Administer by deep (ii) Federal law restricts this drug to intramuscular injection in the thigh at use by or on the order of a licensed vet- weekly intervals, for several weeks. erinarian. (ii) Horses. Administer 25 mg per 100 (4) Administer single injection of 0.1 pounds of body weight by deep milliliter (10 milligrams) intramuscular injection in the gluteal subcutaneously in nape of neck of 1- to region at weekly intervals, for not 3-day-old turkey poults as an aid in more than 4 weeks. control of airsacculitis associated with (2) Indications for use. For use as an M. meleagridis sensitive to anabolic steroid treatment. spectinomycin. (3) Limitations. Do not use in horses [40 FR 13858, Mar. 27, 1975, as amended at 43 intended for human consumption. Fed- FR 9273, Mar. 7, 1978; 46 FR 18964, Mar. 27, eral law restricts this drug to use by or 1981; 47 FR 14149, Apr. 2, 1982; 61 FR 5507, Feb. on the order of a licensed veterinarian. 13, 1996; 61 FR 31028, June 19, 1996; 65 FR 45877, July 26, 2000; 66 FR 22118, May 3, 2001; [79 FR 16195, Mar. 25, 2014] 79 FR 16195, Mar. 25, 2014] § 522.2200 Sulfachlorpyridazine. § 522.2121 Spectinomycin sulfate. (a) Specifications. Each milliliter of (a) Specifications. Each milliliter of solution contains sodium solution contains spectinomycin sul- sulfachlorpyridazine equivalent to 200 fate tetrahydrate equivalent to 100 mil- milligrams (mg) sulfachlorpyridazine. ligrams (mg) spectinomycin. (b) Sponsor. See No. 000010 in (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Related tolerances. See § 556.630 of (c) Related tolerances. See § 556.600 of this chapter. this chapter. (d) Conditions of use in calves. It is (d) Conditions of use in cattle—(1) used as follows: Amount. 10 to 15 mg per kilogram of (1) Amount. Administer 30 to 45 mg body weight at 24-hour intervals for 3 per pound (/lb) of body weight in di- to 5 consecutive days. vided doses by twice daily injection for (2) Indications for use. For the treat- 1 to 5 days. ment of bovine respiratory disease (2) Indications for use. For the treat- (pneumonia) associated with ment of diarrhea caused or complicated Mannheimia haemolytica, Pasteurella by Escherichia coli (colibacillosis). multocida, and Histophilus somni. (3) Limitations. Treated calves must (3) Limitations. Do not slaughter with- not be slaughtered for food during in 11 days of last treatment. Do not use treatment or for 5 days after the last in female dairy cattle 20 months of age treatment. A withdrawal period has or older. Use in this class of cattle may not been established for this product in cause residues in milk. A withdrawal preruminating calves. Do not use in period has not been established for this calves to be processed for veal. product in preruminating calves. Do 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 [72 FR 31178, June 6, 2007, as amended at 79 solution contains: FR 16195, Mar. 25, 2014] (1) 100 milligrams (mg) of sulfadimethoxine sodium. § 522.2150 Stanozolol. (2) 400 mg of sulfadimethoxine so- (a) Specifications. Each milliliter of dium. suspension contains 50 milligrams (mg) (b) Sponsors. See sponsor numbers in of stanozolol. § 510.600(c) of this chapter for use as in (b) Sponsor. No. 054771 in § 510.600(c) of paragraph (d) of this section. this chapter. (1) No. 054628 for use of the product (c) Conditions of use—(1) Amount—(i) described in paragraph (a)(1) as in para- Dogs and cats. For cats and small graph (d)(1) of this section.

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(2) No. 054771 for use of the product lowed by 12.5 mg per pound of body described in paragraph (a)(2) as in para- weight every 24 hours until the animal graphs (d)(2), (3), and (4) of this section. is asymptomatic for 48 hours. (3) Nos. 000859, 057561, and 061623 for (ii) Indications for use. For the treat- use of the product described in para- ment of bovine respiratory disease graph (a)(2) as in paragraph (d)(4) of complex (shipping fever complex) and this section. bacterial pneumonia associated with (c) Related tolerances. See § 556.640 of Pasteurella spp. sensitive to this chapter. sulfadimethoxine; necrotic (d) Conditions of use—(1) Dogs—(i) pododermatitis (foot rot) and calf diph- Amount. Administer by subcutaneous, theria caused by Fusobacterium intramuscular, or intravenous injec- necrophorum sensitive to tion at an initial dose of 25 mg per pound of body weight followed by 12.5 sulfadimethoxine. mg per pound of body weight every 24 (iii) Limitations. Milk taken from ani- hours thereafter. Continue treatment mals during treatment and for 60 hours until the animal is free from symptoms (5 milkings) after the latest treatment for 48 hours. must not be used for food. Do not ad- (ii) Indications for use. For use in the minister within 5 days of slaughter. A treatment of sulfadimethoxine-suscep- withdrawal period has not been estab- tible bacterial infections in dogs. lished for this product in (iii) Limitations. Federal law restricts preruminating calves. Do not use in this drug to use by or on the order of a calves to be processed for veal. licensed veterinarian. (2) Dogs and cats—(i) Amount. Admin- [79 FR 16196, Mar. 25, 2014] ister by intravenous or subcutaneous § 522.2240 Sulfaethoxypyridazine. injection at an initial dose of 55 mg per 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 licensed veterinarian. §§ 520.2240a(e) and 520.2240b(e) of this (3) Horses—(i) Amount. Administer by chapter. intravenous injection at an initial dose (2) Indications for use. For treatment of 55 mg per kilogram of body weight of respiratory infection (pneumonia, followed by 27.5 mg per kilogram of shipping fever), foot rot, calf scours; as body weight every 24 hours until the adjunctive therapy in septicemia ac- patient is asymptomatic for 48 hours. companying mastitis and metritis. (ii) Indications for use. For the treat- (3) Limitations. Do not treat within 16 ment of respiratory disease caused by days of slaughter. Milk that has been Streptococcus equi (strangles). taken from animals during treatment (iii) Limitations. Do not use in horses and for 72 hours (6 milkings) after the intended for human consumption. Fed- latest treatment must not be used for eral law restricts this drug to use by or food. Federal law restricts this drug to on the order of a licensed veterinarian. use by or on the order of a licensed vet- (4) Cattle—(i) Amount. Administer an erinarian. initial dose of 25 mg per pound of body weight by intravenous injection fol- [79 FR 16196, Mar. 25, 2014]

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§ 522.2260 Sulfamethazine. such as colibacillosis and complicated (a) Specifications. Each milliliter chronic respiratory disease. (mL) of solution contains 250 milli- (2) It is administered by subcuta- grams (mg) sulfamethazine sodium. neous injection as follows: (b) Sponsor. See No. 000010 in Antibiotic activity § 510.600(c) of this chapter. Age of birds in days Chickens Turkeys (c) Related tolerances. See § 556.670 of (units) (units) this chapter. (d) Conditions of use in cattle—(1) 1 to 14 ...... 12,500 12,500 15 to 28 ...... 25,000 25,000 Amount. Initially administer 20 mL for 29 to 63 ...... 50,000 50,000 each 50 pounds (lb) of body weight (100 Over 63 ...... 50,000 100,000 mg/lb) by intravenous injection, followed by 20 mL per 100 lb of body (3) A second injection may be given 3 weight (50 mg/lb) by intravenous injec- days later if symptoms persist. tion, daily thereafter. Treatment (4) Not for use in laying hens; do not should not exceed a total of 5 consecu- treat chickens within 5 days of slaugh- tive days. ter; do not treat turkeys within 7 days (2) Indications for use. For cattle for of slaughter. treatment of bacterial pneumonia and bovine respiratory disease complex [40 FR 13858, Mar. 27, 1975, as amended at 79 FR 16196, Mar. 25, 2014] (shipping fever complex) (Pasteurella spp.), colibacillosis (bacterial scours) § 522.2404 Thialbarbitone sodium for (Escherichia coli), necrotic injection. pododermatitis (foot rot) (a) Specifications. Thialbarbitone so- (Fusobacterium necrophorum), calf diph- dium for injection when reconstituted theria (Fusobacterium necrophorum), with sterile distilled water provides 94 acute mastitis and acute metritis milligrams of thialbarbitone sodium (Streptococcus spp.) when caused by one or more pathogenic organisms sen- per milliliter of solution. sitive to sulfamethazine. (b) Sponsor. See No. 054771 in (3) Limitations. Withdraw medication § 510.600(c) of this chapter. from cattle 10 days prior to slaughter. (c) Conditions of use. (1) The drug is Do not use in female dairy cattle 20 administered as a general anesthetic in months of age or older. Federal law re- surgical procedures on dogs, cats, stricts this drug to use by or on the swine, sheep, cattle, and horses. The order of a licensed veterinarian. drug is used for procedures of relatively short duration. However, the [46 FR 62055, Dec. 22, 1981, as amended at 67 period of anesthesia can be lengthened FR 78355, Dec. 24, 2002; 75 FR 10167, Mar. 5, by slower initial injection and supple- 2010; 76 FR 53051, Aug. 25, 2011] mental administration during surgery. § 522.2340 Sulfomyxin. (2) It is administered intravenously. The drug is injected slowly to dogs, (a) Specifications. Sulfomyxin for in- cats, cattle, sheep, and swine. For jection is sterile. It is derived from the horses, it is recommended that a pre- antibiotic substance produced by the anesthetic sedation be administered to growth of Bacillus polymyxa or is the the horse 30 minutes before the drug is same substance produced by any other administered. The drug is then injected means. rapidly and completely. The drug is (b) Sponsor. See No. 054771 in used at the following dosage levels: § 510.600(c) of this chapter. (c) Special considerations. The quan- Weight of animal Dosage in tities of antibiotic in paragraph (e) of Species milligrams in pounds per pound this section refer to the activity of the appropriate standard. Dog ...... Over 50 ...... 14.1 (d) Related tolerances. See § 556.700 of Do ...... 30–50 ...... 18.8 Do ...... 10–30 ...... 23.5 this chapter. Do ...... Under 10 ...... 28.2 (e) Conditions of use. (1) It is used or Cat ...... 31.3–37.6 intended for use in chickens and tur- Horse ...... 6.3–7.8 keys as an aid in the treatment of dis- Cattle and swine ...... 6.7–9.4 ease caused or complicated by E. coli, Calves and sheep ...... 9.4–11.8

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(3) Federal law restricts this drug to (ii) 10 to 12 mg per pound of body use by or on the order of a licensed vet- weight for anesthesia of 15 to 25 min- erinarian. utes duration. (2) Indications for use. It is used as an [40 FR 13858, Mar. 27, 1975, as amended at 79 anesthetic for intravenous administra- FR 16196, Mar. 25, 2014] tion to dogs and cats during short to § 522.2424 Thiamylal. moderately long surgical and other procedures. It is also used to induce an- (a) Specifications. The drug is a sterile esthesia in dogs and cats which then powder. It is reconstituted with sterile have surgical anesthesia maintained by distilled water, water for injection, or use of a volatile anesthetic. sodium chloride injection, to a desired (3) Limitations. Federal law restricts concentration of 0.5 to 4 percent so- this drug to use by or on the order of a dium thiamylal. licensed veterinarian. (b) Sponsors. See Nos. 054628 and 054771 in § 510.600(c) of this chapter. [79 FR 16196, Mar. 25, 2014] (c) Conditions of use—(1) Amount. Ad- § 522.2444b Thiopental and pento- minister by intravenous injection to ef- barbital powder for injection. fect. The average single dose is: (a) Specifications. Each gram of pow- (i) Dogs and cats: 8 milligrams (mg) der contains 750 milligrams (mg) of so- per pound of body weight (when used dium thiopental and 250 mg of sodium 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.

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(ii) Indications for use. For the treat- pound of body weight for minor proce- ment of bovine respiratory disease dures requiring mild to moderate anal- (BRD) associated with Mannheimia gesia, such as repair of lacerations, haemolytica, Pasteurella multocida, and castrations, and other procedures of Histophilus somni in beef and non-lac- short duration. Initial dosages of 6.5 to tating dairy cattle; and for the control 7.2 mg per pound of body weight are of respiratory disease in beef and non- recommended for ovariohysterectomy lactating dairy cattle at high risk of and onychectomy. When supplemental developing BRD associated with M. doses are required, such individual sup- haemolytica, P. multocida, and H. somni. plemental doses should be given in in- (iii) Limitations. Cattle intended for crements that are less than the initial human consumption must not be dose, and the total dose given (initial slaughtered within 21 days from the dose plus supplemental doses) should last treatment. Do not use in female not exceed the maximum allowable dairy cattle 20 months of age or older. safe dose of 32.7 mg per pound of body A withdrawal period has not been es- weight. tablished for this product in (2) Indications for use. For restraint or preruminating calves. Do not use in for anesthesia combined with muscle calves to be processed for veal. Federal relaxation in cats and in dogs for re- law restricts this drug to use by or on straint and minor procedures of short the order of a licensed veterinarian. duration (30 minutes) requiring mild to (2) [Reserved] moderate analgesia. (3) Limitations. Federal law restricts [77 FR 39391, July 3, 2012] this drug to use by or on the order of a § 522.2470 Tiletamine and zolazepam licensed veterinarian. for injection. [79 FR 16197, Mar. 25, 2014] (a) Specifications. The drug is a sterile powder. Each milliliter of constituted § 522.2471 Tilmicosin. solution contains tiletamine hydro- (a) Specifications. Each milliliter of chloride equivalent to 50 milligrams solution contains 300 milligrams (mg) (mg) of tiletamine base and zolazepam tilmicosin base as tilmicosin phos- hydrochloride equivalent to 50 mg of phate. zolazepam base. (b) Sponsor. See No. 000986 in (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Related tolerances. See § 556.735 of (c) Conditions of use in dogs and cats— this chapter. (1) Amount. Expressed as milligrams of (d) Special considerations. (1) Not for the drug combination: human use. Use of this antibiotic in (i) Healthy dogs: An initial humans may prove fatal. Do not use in intramuscular dosage of 3 to 4.5 mg per automatically powered syringes. pound of body weight for diagnostic (2) Federal law restricts this drug to purposes; 4.5 to 6 mg per pound of body use by or on the order of a licensed vet- weight for minor procedures of short erinarian. duration such as repair of lacerations (e) Conditions of use—(1) Cattle—(i) and wounds, castrations, and other pro- Amount. 10 to 20 milligrams per kilo- cedures requiring mild to moderate an- grams (mg/kg) of body weight as a sin- algesia. Supplemental doses when re- gle subcutaneous injection. quired should be less than the initial (ii) Indications for use. For the treat- dose and the total dose given should ment of bovine respiratory disease not exceed 12 mg per pound of body (BRD) associated with Mannheimia weight. The maximum total safe dose haemolytica, Pasteurella multocida, and is 13.6 milligrams per pound of body Histophilus somni. For the control of weight. respiratory disease in cattle at high (ii) Healthy cats: An initial risk of developing BRD associated with intramuscular dosage of 4.4 to 5.4 mg M. haemolytica. per pound of body weight for such pro- (iii) Limitations. Do not use in female cedures as dentistry, treatment of ab- dairy cattle 20 months of age or older. scesses, foreign body removal, and re- Use of this antibiotic in this class of lated types of surgery; 4.8 to 5.7 mg per cattle may cause milk residues. Do not

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slaughter within 42 days of last treat- § 522.2476 Trenbolone acetate. ment. (a) Sponsors. See sponsors in (2) Sheep—(i) Amount. 10 mg/kg body § 510.600(c) of this chapter for use as in weight as a single subcutaneous injec- paragraph (d) of this section. tion. (1) No. 021641 for use as in paragraph (ii) Indications for use. For the treat- (c) of this section. ment of ovine respiratory disease (2) No. 000061 for use as in paragraphs (ORD) associated with Mannheimia (P.) (c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), haemolytica. (c)(2)(i)(A), (c)(2)(ii), and (c)(2)(iii) of (iii) Limitations. Do not slaughter this section. within 28 days of last treatment. (b) Related tolerances. See § 556.739 of [67 FR 72367, Dec. 5, 2002, as amended at 75 this chapter. FR 9334, Mar. 2, 2010] (c) Conditions of use—(1) Steers fed in confinement for slaughter—(i) Amount. § 522.2473 Tiludronate. Use 126 days prior to slaughter; should (a) Specifications. Each vial of powder be reimplanted once after 63 days. contains 500 milligrams (mg) (A) 140 milligrams (mg) trenbolone tiludronate disodium. Each milliliter acetate (one implant consisting of 7 of constituted solution contains 20 mg pellets, each pellet containing 20 mg tiludronate disodium. trenbolone acetate) per implant dose. (b) Sponsor. See No. 013744 in (B) 140 mg trenbolone acetate (one § 510.600(c) of this chapter. implant consisting of 8 pellets, each of (c) Conditions of use in horses—(1) 7 pellets containing 20 milligrams Amount. Administer a single dose of 1 trenbolone acetate, and 1 pellet con- mg per kilogram (0.45 mg/pound) of taining 29 mg tylosin tartrate) per im- body weight by intravenous infusion. plant dose. (2) Indication for use. For the control (ii) Indications for use. For improved of clinical signs associated with navic- feed efficiency. ular syndrome. (iii) Limitations. Implant (3) Limitations. Do not use in horses subcutaneously in ear only. Do not use intended for human consumption. Fed- in animals intended for subsequent eral law restricts this drug to use by or breeding or in dairy animals. Safety on the order of a licensed veterinarian. and effectiveness have not been established in veal calves. A withdrawal pe- [79 FR 18159, Apr. 1, 2014] riod has not been established for this § 522.2474 Tolazoline. product in preruminating calves. Do not use in calves to be processed for (a) Specifications. Each milliliter of veal. solution contains tolazoline hydro- (2) Heifers fed in confinement for chloride equivalent to 100 milligrams slaughter—(i) Amount. Use last 63 days (mg) of base activity. prior to slaughter. (b) Sponsor. See No. 061690 in (A) 200 mg trenbolone acetate (one § 510.600(c) of this chapter. implant consisting of 10 pellets, each (c) Conditions of use in horses—(1) pellet containing 20 mg trenbolone ace- Amount. Administer slowly by intra- tate) per implant dose. venous injection 4 mg per kilogram of (B) 200 mg of trenbolone acetate (one body weight or 1.8 mg per pound (4 mil- implant consisting of 11 pellets, each of liliters (mL) per 100 kilograms or 4 mL 10 pellets containing 20 mg of per 220 pounds). trenbolone acetate, and 1 pellet con- (2) Indications for use. For use in taining 29 mg of tylosin tartrate) per horses when it is desirable to reverse implant dose. the effects of sedation and analgesia (ii) Indications for use. For increased caused by xylazine. rate of weight gain and improved feed (3) Limitations. Do not use in horses 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 16197, Mar. 25, 2014] breeding or in dairy animals. Safety

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and effectiveness have not been estab- trenbolone acetate and 4 mg estradiol) lished in veal calves. A withdrawal pe- per implant dose. riod has not been established for this (E) 200 mg trenbolone acetate and 20 product in preruminating calves. Do mg estradiol (one implant consisting of not use in calves to be processed for 11 pellets, each of 10 pellets containing veal. 20 mg trenbolone acetate and 2 mg es- [66 FR 47961, Sept. 17, 2001, as amended at 69 tradiol, and 1 pellet containing 29 mg FR 70056, Dec. 2, 2004; 74 FR 61517, Nov. 25, tylosin tartrate) per implant dose. 2009] (F) 80 mg trenbolone acetate and 16 mg estradiol (one implant consisting of EDITORIAL NOTE: At 77 FR 31723, May 30, 2012, § 522.2476 was amended in paragraph 5 pellets, each of 4 pellets containing 20 (b)(l) by removing ‘‘021641’’ and in its place mg trenbolone acetate and 4 mg estra- adding ‘‘000986’’; however, the amendment diol, and 1 pellet containing 29 mg could not be incorporated because (b)(1) tylosin tartrate) per implant dose. doesn’t exist. (G) 200 milligram (mg) trenbolone acetate and 40 mg estradiol (one implant § 522.2477 Trenbolone acetate and es- consisting of 10 pellets, each pellet con- tradiol. taining 20 mg trenbolone acetate and 4 (a) [Reserved] mg estradiol) per implant dose. (b) Sponsors. See sponsors in (ii) Indications for use. For increased § 510.600(c) of this chapter for uses as in rate of weight gain and improved feed paragraph (d) of this section. efficiency. (1) No. 000986 for use as in paragraphs (iii) Limitations. Implant (d)(1)(i)(A), (d)(1)(i)(B), (d)(1)(i)(C), subcutaneously in ear only. Do not use (d)(1)(i)(D), (d)(1)(i)(E), (d)(1)(i)(F), in animals intended for subsequent (d)(1)(ii), (d)(1)(iii), (d)(2), and (d)(3) of breeding or in dairy animals. Safety this section. and effectiveness have not been estab- (2) No. 000061 for use as in paragraphs lished in veal calves. A withdrawal pe- (d)(1)(i)(A), (d)(1)(i)(C), (d)(1)(i)(D), riod has not been established for this (d)(1)(i)(G), (d)(1)(ii), (d)(1)(iii), product in preruminating calves. Do (d)(2)(i)(A), (d)(2)(i)(C), (d)(2)(i)(D), not use in calves to be processed for (d)(2)(ii), (d)(2)(iii), (d)(3)(i)(A), veal. (d)(3)(ii), and (d)(3)(iii) of this section. (2) Heifers fed in confinement for (3) No. 054771 for use as in paragraphs slaughter—(i) Amount. (A) 140 mg (d)(1)(i)(A), (d)(1)(i)(D), (d)(1)(ii), trenbolone acetate and 14 mg estradiol (d)(1)(iii), (d)(3)(i)(A), (d)(3)(ii), and (one implant consisting of 7 pellets, (d)(3)(iii) of this section. 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 (D) 80 mg trenbolone acetate and 16 mg estradiol (one implant consisting of mg estradiol (one implant consisting of 10 pellets, each pellet containing 20 mg 4 pellets, each pellet containing 20 mg trenbolone acetate and 2 mg estradiol)

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per implant dose for use as in para- Finding Aids section of the printed volume graph (d)(2)(ii)(A) of this section. and at www.fdsys.gov. (E) 80 mg trenbolone acetate and 8 mg estradiol (one implant consisting of § 522.2478 Trenbolone acetate and estradiol benzoate. 5 pellets, each of 4 pellets containing 20 mg trenbolone acetate and 2 mg (a) Specifications. Each implant dose estradiol, and 1 pellet containing 29 mg consists of: tylosin tartrate) per implant dose for (1) 8 pellets, each pellet containing 25 use as in paragraph (d)(2)(ii)(B) of this milligrams (mg) trenbolone acetate section. and 3.5 mg estradiol benzoate. (F) 200 mg trenbolone acetate and 20 (2) 4 pellets, each pellet containing 25 mg estradiol (one implant consisting of mg trenbolone acetate and 3.5 mg es- 11 pellets, each of 10 pellets containing tradiol benzoate. (b) Sponsor. See No. 054771 in 20 mg trenbolone acetate and 2 mg es- § 510.600(c) of this chapter. tradiol, and 1 pellet containing 29 mg (c) Related tolerances. See §§ 556.240 tylosin tartrate) per implant dose. and 556.739 of this chapter. (ii) Indications for use. (A) For in- (d) Conditions of use—(1) Steers fed in creased rate of weight gain and im- confinement for slaughter. (i) For an improved feed efficiency. plant as described in paragraph (a)(1) of (B) For increased rate of weight gain. this section: (iii) Limitations. Implant (A) Amount. 200 mg trenbolone ace- subcutaneously in ear only. Do not use tate and 28 mg estradiol benzoate. in animals intended for subsequent (B) Indications for use. For increased breeding or in dairy animals. Safety rate of weight gain and improved feed and effectiveness have not been estab- efficiency. lished in veal calves. A withdrawal pe- (C) Limitations. Implant riod has not been established for this subcutaneously in ear only. Safety and product in preruminating calves. Do effectiveness have not been established not use in calves to be processed for in veal calves. A withdrawal period has veal. not been established for this product in (3) Pasture cattle (slaughter, stocker, preruminating calves. Do not use in and feeder steers and heifers)—(i) calves to be processed for veal. Amount. (A) 40 mg trenbolone acetate (ii) For an implant as described in and 8 mg estradiol (one implant con- paragraph (a)(2) of this section: sisting of 2 pellets, each pellet con- (A) Amount. 100 mg trenbolone ace- taining 20 mg trenbolone acetate and 4 tate and 14 mg estradiol benzoate. mg estradiol) per implant dose. (B) Indications for use. For increased (B) 40 mg trenbolone acetate and 8 rate of weight gain. mg estradiol (one implant consisting of (C) Limitations. Implant 3 pellets, each of 2 pellets containing 20 subcutaneously in ear only. Safety and mg trenbolone acetate and 4 mg estra- effectiveness have not been established diol, and 1 pellet containing 29 mg in veal calves. A withdrawal period has tylosin tartrate) per implant dose. not been established for this product in (ii) Indications for use. For increased preruminating calves. Do not use in rate of weight gain. calves to be processed for veal. (iii) Limitations. Implant (2) Heifers fed in confinement for subcutaneously in ear only. Do not use slaughter—(i) Amount. 200 mg in animals intended for subsequent trenbolone acetate and 28 mg estradiol breeding or in dairy animals. Safety benzoate (as described in paragraph and effectiveness have not been estab- (a)(1) of this section). lished in veal calves. A withdrawal pe- (ii) Indications for use. For increased riod has not been established for this rate of weight gain. product in preruminating calves. Do (iii) Limitations. Implant not use in calves to be processed for subcutaneously in ear only. Not for veal. subsequent breeding dairy or beef re- [60 FR 4376, Jan. 23, 1995] placement heifers. Safety and effec- EDITORIAL NOTE: For FEDERAL REGISTER ci- tiveness have not been established in tations affecting § 522.2477, see the List of veal calves. A withdrawal period has CFR Sections Affected, which appears in the not been established for this product in

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preruminating calves. Do not use in days, repeat dosage if indicated. If ini- calves to be processed for veal. tial results are inadequate or too tran- sient, dosage may be increased, not to [67 FR 78972, Dec. 27, 2002, as amended at 69 FR 67818, Nov. 22, 2004; 79 FR 16197, Mar. 25, exceed 18 mg. 2014] (ii) Indications for use. For the treatment of inflammation and related dis- § 522.2483 Triamcinolone. orders. (a) Specifications. Each milliliter of (iii) Limitations. Do not use in horses suspension contains 2 or 6 milligrams intended for human consumption. Fed- (mg) triamcinolone acetonide. eral law restricts this drug to use by or (b) Sponsor. See No. 054628 in on the order of a licensed veterinarian. § 510.600(c) of this chapter. [75 FR 10167, Mar. 5, 2010, as amended at 78 (c) Conditions of use—(1) Dogs and FR 21060, Apr. 9, 2013] cats—(i) Amount—(A) Intramuscular or subcutaneous. For inflammatory, ar- § 522.2582 Triflupromazine. thritic, or allergic disorders, admin- (a) Specifications. Each milliliter of ister 0.05 to 0.1 mg per pound (/lb) of solution contains 20 milligrams (mg) of body weight as a single injection. For triflupromazine hydrochloride. dermatologic disorders, administer 0.1 (b) Sponsor. See No. 054771 in mg per pound (/lb) of body weight as a § 510.600(c) of this chapter. single injection. If symptoms recur, the (c) Conditions of use—(1) Amount—(i) dose may be repeated, or oral Dogs. Administer by intravenous injec- corticosteroid therapy may be insti- tion at a dosage of 0.5 to 1 mg per tuted. pound of body weight daily, or by (B) Intralesional. Administer 1.2 to 1.8 intramuscular injection at a dosage of mg, divided in several injections 1 to 2 mg per pound of body weight around the lesion, spaced 0.5 to 2.5 cen- daily. timeters apart, depending on lesion (ii) Cats. Administer by size. At any one site, the dose injected intramuscular injection at a dosage of should not exceed 0.6 mg. and should be 2 to 4 mg per pound of body weight well into the cutis to prevent rupture daily. of the epidermis. When treating ani- (iii) Horses. Administer by intra- mals with multiple lesions, do not ex- venous or intramuscular injection at a ceed a total dose of 6 mg. dosage of 10 to 15 mg per 100 pounds of (C) Intra-articular and intrasynovial. body weight daily to a maximum dose Administer 1 to 3 mg as a single injec- of 100 mg. tion, depending on the size of the joint (2) Indications for use. For use in dogs, and severity of symptoms. After 3 or 4 cats, and horses to relieve anxiety and days, repeat dosage if indicated. If ini- to help control psychomotor over- tial results are inadequate or too tran- activity as well as to increase the tol- sient, dosage may be increased, not to erance of animals to pain and pruritus. exceed 3 mg. The drug is indicated in various office (ii) Indications for use. For the treat- and clinical procedures which require ment of inflammation and related dis- the aid of a tranquilizer, antiemetic, or orders, and the management and treat- preanesthetic. ment of acute arthritis and allergic (3) Limitations. Do not use in horses and dermatologic disorders. intended for human consumption. Fed- (iii) 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. (2) Horses—(i) Amount—(A) [79 FR 16197, Mar. 25, 2014] Intramuscular or subcutaneous. Admin- ister 0.01 to 0.02 mg/lb of body weight as § 522.2610 Trimethoprim and sulfa- a single injection. Usual dose is 12 to 20 diazine. mg. (a) Specifications. Each milliliter (B) Intra-articular and intrasynovial. (mL) contains: Administer 6 to 18 mg as a single injec- (1) 40 milligrams (mg) trimethoprim tion, depending on the size of the joint suspended in a solution containing 200 and severity of symptoms. After 3 or 4 mg sulfadiazine; or

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(2) 80 mg trimethoprim suspended in taminic therapy may be expected to a solution containing 400 mg sulfa- lead to alleviation of some signs of dis- diazine (as the sodium salt). ease. (b) Sponsors. See Nos. 000061 and (iii) Limitations. Federal law restricts 054771 in § 510.600(c) of this chapter. this drug to use by or on the order of a (c) Conditions of use—(1) Dogs—(i) licensed veterinarian. Amount. 1 mL of the product described (2) Horses—(i) Amount. Administer 0.5 in paragraph (a)(1) of this section (40 mg per pound of body weight by mg trimethoprim and 200 mg sulfa- intramuscular injection. diazine) per 20 pounds (9 kilograms) of (ii) Indications for use. For use in body weight per day by subcutaneous treating conditions in which antihis- injection. taminic therapy may be expected to (ii) Indications for use. For the treat- lead to alleviation of some signs of dis- ment of acute urinary tract infections, ease. acute bacterial complications of dis- (iii) Limitations. Do not use in horses temper, acute respiratory tract infec- intended for human consumption. Fed- tions, acute alimentary tract infec- eral law restricts this drug to use by or tions, and acute septicemia due to on the order of a licensed veterinarian. Streptococcus zooepidemicus. (3) Cattle—(i) Amount. Administer 0.5 (iii) Limitations. Federal law restricts mg per pound of body weight by intra- this drug to use by or on the order of a venous or intramuscular injection. licensed veterinarian. (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 (iii) Limitations. Treated cattle must intravenous injection as single, daily not be slaughtered for food during dose for 5 to 7 days. The daily dose may treatment and for 4 days following the also be halved and given morning and last treatment. Milk that has been evening. 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 FR 29480, June 11, 1996; 62 FR 4164, Jan. 29, on the order of a licensed veterinarian. 1997; 78 FR 17597, Mar. 22, 2013; 79 FR 16198, [71 FR 30803, May 31, 2006, as amended at 79 Mar. 25, 2014] FR 16197, Mar. 25, 2014] § 522.2630 Tulathromycin. § 522.2615 Tripelennamine. (a) Specifications. Each milliliter of (a) Specifications. Each milliliter of solution contains: solution contains 20 milligrams (mg) of (1) 100 milligrams (mg) tripelennamine hydrochloride. tulathromycin (b) Sponsors. See Nos. 000859 and (2) 25 mg tulathromycin 054771 in § 510.600(c) of this chapter. (b) Sponsor. See No. 054771 in (c) Related tolerances. See § 556.741 of § 510.600(c) of this chapter for use as in this chapter. paragraph (d) of this section: (d) Conditions of use—(1) Dogs and (1) Product described as in paragraph cats—(i) Amount. Administer 0.5 mg per (a)(1) for use as in paragraph (d). pound of body weight by intramuscular (2) Product described as in paragraph injection. (a)(2) for use as in paragraph (d)(2). (ii) Indications for use. For use in (c) Related tolerances. See § 556.745 of treating conditions in which antihis- this chapter.

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(d) Conditions of use—(1) Beef and non- § 522.2640 Tylosin. lactating dairy cattle—(i) Amount. 2.5 mg (a) Specifications. Each milliliter of per kilogram (/kg) body weight as a solution contains 50 or 200 milligrams single subcutaneous injection in the of tylosin activity (as tylosin base). neck. (b) Sponsors. See sponsor numbers in (ii) Indications for use. For the treat- § 510.600(c) of this chapter for use as in ment of bovine respiratory disease paragraph (d) of this section. (BRD) associated with Mannheimia (1) No. 000986 for use in paragraphs haemolytica, Pasteurella multocida, (d)(1), (2), and (3) of this section. Histophilus somni, and Mycoplasma bovis. (2) No. 000010 for use as in paragraphs For the control of respiratory disease (d)(1) and (2) of this section. in cattle at high risk of developing (c) Related tolerances. See § 556.740 of BRD associated with M. haemolytica, P. this chapter. multocida, H. somni, and M. bovis. For (d) Conditions of use—(1) Beef cattle the treatment of infectious bovine and nonlactating dairy cattle—(i) keratoconjunctivitis associated with Amount. 8 milligrams per pound of body Moraxella bovis. For the treatment of weight once daily. (ii) Treatment of bovine foot rot (interdigital Indications for use. bovine respiratory complex (shipping necrobacillosis) associated with fever, pneumonia) usually associated Fusobacterium necrophorum and with Pasteurella multocida and Porphyromonas levii. Arcanobacterium pyogenes; foot rot (ne- (iii) Limitations. Cattle intended for crotic pododermatitis) and calf diph- human consumption must not be theria caused by Fusobacterium slaughtered within 18 days from the necrophorum and metritis caused by last treatment. Do not use in female Arcanobacterium pyogenes. dairy cattle 20 months of age or older. (iii) Limitations. Administer A withdrawal period has not been es- intramuscularly for not more than 5 tablished for this product in consecutive days. Continue treatment preruminating calves. Do not use in 24 hours after symptoms disappear. Use calves to be processed for veal. Federal a 50-milligram-per-milliliter solution law restricts this drug to use by or on for calves weighing less than 200 the order of a licensed veterinarian. pounds. Do not inject more than 10 mil- (2) Swine—(i) Amount. 2.5 mg/kg body liliters per site. Do not administer weight as a single intramuscular injec- within 21 days of slaughter. This drug tion in the neck. product is not approved for use in fe- (ii) Indications for use. For the treat- male dairy cattle 20 months of age or ment of swine respiratory disease older, including dry dairy cows. Use in (SRD) associated with Actinobacillus these cattle may cause drug residues in pleuropneumoniae, P. multocida, milk and/or in calves born to these Bordetella bronchiseptica, Haemophilus cows. A withdrawal period has not been established for this product in parasuis, and Mycoplasma preruminating calves. Do not use in hyopneumoniae; and for the control of calves to be processed for veal. SRD associated with A. (2) Swine—(i) Amount. 4 milligrams pleuropneumoniae, P. multocida, and M. per pound of body weight twice daily. hyopneumoniae in groups of pigs where (ii) Indications for use. Treatment of SRD has been diagnosed. swine arthritis caused by Mycoplasma (iii) Limitations. Swine intended for hyosynoviae; swine pneumonia caused human consumption must not be by Pasteurella spp.; swine erysipelas slaughtered within 5 days from the last caused by Erysipelothrix rhusiopathiae; treatment. Federal law restricts this swine dysentery associated with drug to use by or on the order of a li- Treponema hyodysenteriae when fol- censed veterinarian. lowed by appropriate medication in the [70 FR 39918, July 12, 2005, as amended at 71 drinking water and/or feed. FR 57416, Sept. 29, 2006; 72 FR 54540, Sept. 26, (iii) Limitations. Administer 2007; 73 FR 6018, Feb. 1, 2008; 73 FR 58872, Oct. intramuscularly for not more than 3 8, 2008; 74 FR 53165, Oct. 16, 2009; 78 FR 63872, consecutive days. Continue treatment Oct. 25, 2013] 24 hours after symptoms disappear. Do

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not inject more than 5 milliliters per (3) Nos. 000859 and 061651 for use of site. Do not administer within 14 days product described in paragraph (a)(1) of of slaughter. If tylosin medicated this section as in paragraph (d)(1); and drinking water is used as followup product described in paragraph (a)(2) of treatment for swine dysentery, the ani- this section as in paragraphs (d)(2), mal should thereafter receive feed con- (d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of taining 40 to 100 grams of tylosin per this section. ton for 2 weeks to assure depletion of (4) No. 061690 for use of product de- tissue residues. scribed in paragraph (a)(1) of this sec- (3) Dogs and cats—(i) Amount. Admin- tion as in paragraph (d)(1) of this sec- ister 3 to 5 milligrams per pound of tion; product described in paragraph body weight by intramuscular injec- (a)(2) of this section as in paragraphs tion at 12- to 24-hour intervals. Use 50 (d)(2), (d)(3)(i), (d)(3)(ii)(A), and milligram per milliliter solution only. (d)(3)(iii) of this section; and product (ii) Indications for use—(a) Dogs. described in paragraph (a)(3) of this Treatment of upper respiratory infec- section as in paragraphs (d)(3)(i), tions such as bronchitis, (d)(3)(ii)(B), and (d)(3)(iii) of this sec- tracheobronchitis, tracheitis, laryn- tion. gitis, tonsillitis, and pneumonia caused (c) Special considerations. Federal law by Staphylococci spp., hemolytic restricts this drug to use by or on the Streptococci spp., and Pasteurella order of a licensed veterinarian. multocida. (d) Conditions of use—(1) Dogs and (b) Cats. Treatment of upper res- cats—(i) Amount. 0.5 mg/pound (lb) in- piratory infections when caused by travenously or 1.0 mg/lb Staphylococci spp. and hemolytic subcutaneously. Streptococci spp. and for feline pneumo- (ii) Indications for use. To produce se- nitis when caused by tylosin suscep- dation, as an analgesic, and as a tible organisms. preanesthetic to local or general anes- (iii) Limitations. Federal law restricts thesia. this drug to use by or on the order of a (2) Horses—(i) Amount. 0.5 mg/lb intra- licensed veterinarian. venously or 1.0 mg/lb intramuscularly. (ii) Indications for use. To produce se- [46 FR 48643, Oct. 2, 1981, as amended at 47 FR dation, as an analgesic, and as a 9398, Mar. 5, 1982; 50 FR 49841, Dec. 5, 1985; 50 FR 50292, Dec. 10, 1985; 53 FR 40728, Oct. 18, preanesthetic to local or general anes- 1988; 59 FR 14365, Mar. 28, 1994; 62 FR 35077, thesia. June 30, 1997; 68 FR 24879, May 9, 2003; 70 FR (iii) Limitations. Do not use in horses 16935, Apr. 4, 2005. Redesignated and amended intended for human consumption. at 74 FR 11644, Mar. 19, 2009; 79 FR 16198, Mar. (3) Elk and deer—(i) Amount. Admin- 25, 2014] ister intramuscularly, by hand syringe, or by syringe dart, in the heavy mus- § 522.2662 Xylazine. cles of the croup or shoulder as follows: (a) Specifications. Each milliliter (A) Elk (Cervus canadensis): 0.25 to 0.5 (mL) of solution contains xylazine hy- mg/lb. drochloride equivalent to: (B) Mule deer (Odocoileus hemionus), (1) 20 milligrams (mg) xylazine. sika deer (Cervus nippon), and white- (2) 100 mg xylazine. tailed deer (Odocoileus virginianus): 1 to (3) 300 mg xylazine. 2 mg/lb. (b) Sponsors. See sponsors in (C) Fallow deer (Dama dama): 2 to 4 § 510.600(c) of this chapter for uses as in mg/lb. paragraph (d) of this section. (ii) Indications for use. (A) To produce (1) No. 054628 for use of product de- sedation, as an analgesic, and as a scribed in paragraph (a)(2) of this sec- preanesthetic to local anesthesia. tion as in paragraph (d)(2) of this sec- (B) To produce sedation, accom- tion. panied by a shorter period of analgesia. (2) No. 000010 for use of product de- May be used to calm and facilitate han- scribed in paragraph (a)(2) of this sec- dling of fractious animals for diag- tion as in paragraphs (d)(2), (d)(3)(i), nostic procedures, for minor surgical (d)(3)(ii)(A), and (d)(3)(iii) of this sec- procedures, for therapeutic medication tion. for sedation and relief of pain following

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injury or surgery, and as a (d) Conditions of use—(1) Beef cattle— preanesthetic to local anesthetic. At (i) Amount. 36 mg zeranol (one implant the recommended dosages, can be used consisting of 3 pellets, each pellet con- in conjunction with local anesthetics, taining 12 mg zeranol) per implant such as procaine or lidocaine. dose. (iii) Limitations. Do not use in domes- (ii) Indications for use—(A) For in- tic food-producing animals. Do not use creased rate of weight gain and im- in Cervidae less than 15 days before or proved feed conversion in weaned beef during the hunting season. calves, growing beef cattle, feedlot [68 FR 26206, May 15, 2003, as amended at 75 steers, and feedlot heifers. FR 10167, Mar. 5, 2010, 78 FR 21060, Apr. 9, (B) For increased rate of weight gain 2013; 79 FR 16198, Mar. 25, 2014] in suckling calves. (iii) Limitations. Implant § 522.2670 Yohimbine. subcutaneously in ear only. Do not use (a) Specifications. Each milliliter of in bulls intended for reproduction or in solution contains either 2 or 5 milli- dairy animals. Do not use before 1 grams of yohimbine (as hydrochloride). month of age or after weaning in heif- (b) Sponsor. See 061690 in § 510.600(c) of ers intended for reproduction. Safety this chapter for use of 2 milligrams per and effectiveness have not been estab- milliliter solution in dogs. lished in veal calves. A withdrawal pe- (1) Amount. 0.05 milligram per pound riod has not been established for this (0.11 milligram per kilogram) of body product in preruminating calves. Do weight. not use in calves to be processed for (2) Indications for use. To reverse the veal. effects of xylazine in dogs. (2) Feedlot lambs—(i) Amount. 12 mg (3) Limitations. For intravenous use in zeranol (one implant consisting of 1 dogs only. Not for use in food-pro- pellet containing 12 mg zeranol) per ducing animals. Safety of use in preg- implant dose. nant dogs or in dogs intended for breed- (ii) Indications for use. For increased ing has not been established. Federal rate of weight gain and improved feed law restricts this drug to use by or on conversion. the order of a licensed veterinarian. (iii) Limitations. Implant (c) Sponsor. See 053923 in § 510.600(c) of subcutaneously in ear only. Do not use this chapter for use of 5 milligrams per in breeding animals. Do not implant milliliter solution in deer and elk. animals within 40 days of slaughter. (1) Amount. 0.2 to 0.3 milligram per Safety and effectiveness have not been kilogram of body weight. established in veal calves. A with- (2) Indications for use. As an antago- drawal period has not been established nist to xylazine sedation in free rang- for this product in preruminating ing or confined members of the family calves. Do not use in calves to be proc- Cervidae (deer and elk). essed for veal. (3) Limitations. For intravenous use (3) Steers fed in confinement for slaugh- only. Do not use in domestic food-pro- ter—(i) Amount. 72 mg zeranol (one im- ducing animals. Do not use for 30 days plant consisting of 6 pellets, each pel- before or during hunting season. Fed- let containing 12 mg zeranol) per im- eral law restricts this drug to use by or plant dose. on the order of a licensed veterinarian. (ii) Indications for use. For increased [58 FR 8543, Feb. 16, 1993, as amended at 60 rate of weight gain and improved feed FR 57832, Nov. 22, 1995; 79 FR 16198, Mar. 25, efficiency. 2014] (iii) Limitations. Implant subcutaneously in ear only. Safety and § 522.2680 Zeranol. effectiveness have not been established (a) Specifications. Each pellet con- in veal calves. A withdrawal period has tains 12, 18, or 20 milligrams (mg) not been established for this product in zeranol. preruminating calves. Do not use in (b) Sponsor. See 000061 in § 510.600(c) of calves to be processed for veal. this chapter. (4) Pasture cattle (slaughter, stocker, (c) Related tolerances. See § 556.760 of feeder steers, and heifers)—(i) Amount. this chapter. 138 mg zeranol (one implant consisting

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of 7 pellets, each of 6 pellets containing 524.775 Emodepside and praziquantel. 20 mg zeranol and a seventh pellet con- 524.802 Enrofloxacin and silver sulfadiazine taining 18 mg zeranol) per implant otic emulsion. dose. 524.814 Eprinomectin. 524.900 Famphur. (ii) Indications for use. For increased 524.920 Fenthion. rate of weight gain. 524.916 Fentanyl. (iii) Limitations. Implant 524.960 Flumethasone, neomycin, and poly- subcutaneously in ear only. Safety and myxin B ophthalmic solution. effectiveness have not been established 524.981 [Reserved] in veal calves. A withdrawal period has 524.981a Fluocinolone cream. not been established for this product in 524.981b Fluocinolone solution. preruminating calves. Do not use in 524.981c Fluocinolone and neomycin cream. calves to be processed for veal. 524.981d Fluocinolone and dimethyl sulfoxide solution. [59 FR 19639, Apr. 25, 1994; 60 FR 26360, May 524.981e Fluocinolone and dimethyl sulf- 17, 1995, as amended at 62 FR 61625, Nov. 19, oxide otic solution. 1997; 64 FR 46840, Aug. 27, 1999; 67 FR 6867, 524.1005 Furazolidone powder. Feb. 14, 2002; 70 FR 6764, Feb. 9, 2005] 524.1044 Gentamicin sophthalmic and topical dosage forms. § 522.2690 Zinc gluconate. 524.1044a Gentamicin ophthalmic solution. (a) Specifications. Each milliliter of 524.1044b Gentamicin and betamethasone otic solution. solution contains 13.1 milligrams zinc 524.1044c Gentamicin ophthalmic ointment. as zinc gluconate neutralized to pH 7.0 524.1044d Gentamicin and betamethasone with L-arginine. ointment. (b) Sponsor. See No. 076175 in 524.1044e Gentamicin spray. § 510.600(c) of this chapter. 524.1044f Gentamicinand betamethasone (c) Conditions of use in dogs—(1) spray. Amount. The volume injected into each 524.1044g Gentamicin, betamethasone, and testicle is based on testicular width as clotrimazole ointment. determined by measuring each testicle 524.1044h Gentamicin, mometasone, and clotrimazole otic suspension. at its widest point using a metric scale 524.1044i Gentamicin and betamethasone (millimeter) caliper. ophthalmic solution. (2) Indications for use. Intratesticular 524.1132 Hydrocortisone, miconazole, and injection for chemical sterilization of gentamicin otic suspension. 3- to 10-month-old male dogs. 524.1140 Imidacloprid and ivermectin. (3) Limitations. Federal law restricts 524.1146 Imidacloprid and moxidectin. this drug to use by or on the order of a 524.1193 Ivermectin topical solution. licensed veterinarian. 524.1195 Ivermectin otic suspension. 524.1200 Kanamycin ophthalmic and topical [68 FR 26995, May 19, 2003, as amended at 76 dosage forms. FR 79064, Dec. 21, 2011] 524.1200a Kanamycin ophthalmic ointment. 524.1200b Kanamycin ophthalmic solution. PART 524—OPHTHALMIC AND TOP- 524.1204 Kanamycin, amphomycin, and hydrocortisone ointment. ICAL DOSAGE FORM NEW ANI- 524.1240 Levamisole. MAL DRUGS 524.1376 2-Mercaptobenzothiazole solution. 524.1443 Miconazole. Sec. 524.1445 Miconazole, polymixin B, and pred- 524.86 Amitraz. nisolone suspension. 524.154 Bacitracin, neomycin, and poly- 524.1446 Milbemycin otic solution. myxin B ophthalmic ointment. 524.1450 Moxidectin. 524.155 Bacitracin, neomycin, polymyxin B, 524.1465 Mupirocin. and hydrocortisone ophthalmic oint- 524.1484 Neomycin ophthalmic and topical ment. dosage forms. 524.390 Chloramphenicol ophthalmic oint- 524.1484b Neomycin, isoflupredone, tetra- ment. caine, and myristyl-gamma-picolinium 524.402 Chlorhexidine. powder. 524.450 Clotrimazole. 524.1484c Neomycin, isoflupredone, and tet- 524.463 Copper naphthenate. racaine ointment. 524.575 Cyclosporine ophthalmic ointment. 524.1484d Neomycin, hydrocortisone, and 524.590 Diclofenac. tetracaine otic ointment. 524.660 Dimethyl sulfoxide. 524.1484e Neomycin and polymyxin B oph- 524.770 Doramectin. thalmic solution.

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524.1484f Neomycin, prednisolone, and tetra- (3) Limitations. Federal law restricts caine otic suspension. this drug to use by or on the order of a 524.1484g Neomycin, thiabendazole, and licensed veterinarian. dexamethasone solution. 524.1484h Neomycin, penicillin, polymyxin [47 FR 18589, Apr. 30, 1982, as amended at 79 B, and hydrocortisone suspension. FR 10967, Feb. 27, 2014] 524.1484i Neomycin and hydrocortisone ointment. § 524.154 Bacitracin, neomycin, and 524.1484j Neomycin and prednisolone oph- polymyxin B ophthalmic ointment. thalmic ointment. 524.1484k Prednisolone and neomycin sus- (a) Specifications. Each gram of oint- pension. ment contains: 524.1580 Nitrofurazone topical dosage forms. (1) 500 units of bacitracin, 3.5 milli- 524.1580a Nitrofurazone ointment. grams of neomycin, and 10,000 units of 524.1580b Nitrofurazone soluble powder. polymyxin B sulfate; or 524.1580c Nitrofurazone and butacaine oint- (2) 400 units of bacitracin zinc, 3.5 ment. 524.1600 Nystatin ophthalmic and topical milligrams of neomycin, and 10,000 dosage forms. units of polymyxin B sulfate. 524.1600a Nystatin, neomycin, thiostrepton, (b) Sponsors. See sponsor numbers in and triamcinolone ointment. § 510.600(c) of this chapter as follows: 524.1600b Nystatin, neomycin, thiostrepton, (1) No. 054771 for use of product de- and triamcinolone ophthalmic ointment scribed in paragraph (a)(1) as in para- 524.1610 Orbifloxacin, mometasone furoate monohydrate, and posaconazole suspen- graph (c) of this section. sion. (2) Nos. 000061 and 043264 for use of 524.1662 Oxytetracycline ophthalmic and product described in paragraph (a)(2) as topical dosage forms. in paragraph (c) of this section. 524.1662a Oxytetracycline and hydro- (c) Conditions of use in dogs and cats.— cortisone spray. (1) Amount. Apply a thin film over the 524.1662b Oxytetracycline and polymyxin B ophthalmic ointment. cornea 3 or 4 times daily. 524.1742 N-(Mercaptomethyl) phthalimide S- (2) Indications for use. Treatment of (O,O-dimethyl phosphorodithioate) emul- superficial bacterial infections of the sifiable liquid. eyelid and conjunctiva of dogs and cats 524.1982 Proparacaine ophthalmic solution. when due to susceptible organisms. 524.2098 Selamectin. (3) Limitations. Federal law restricts 524.2101 Selenium disulfide suspension. this drug to use by or on the order of a 524.2350 Tolnaftate cream. 524.2482 Triamcinolone spray. licensed veterinarian. 524.2483 Triamcinolone cream. [57 FR 37333, Aug. 18, 1992, as amended at 61 524.2620 Liquid crystalline trypsin, Peru FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, balsam, castor oil. 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, AUTHORITY: 21 U.S.C. 360b. Feb. 27, 2014] SOURCE: 40 FR 13873, Mar. 27, 1975, unless § 524.155 Bacitracin, neomycin, poly- otherwise noted. myxin B, and hydrocortisone ophthalmic ointment. § 524.86 Amitraz. (a) Specifications. Each gram of oint- (a) Specifications. Amitraz liquid contains 19.9 percent amitraz in an organic ment contains 400 units of bacitracin solvent. zinc, 5 milligrams (mg) of neomycin (b) Sponsor. See No. 054771 in sulfate (equivalent to 3.5 mg of neomy- § 510.600(c) of this chapter. cin sulfate), 10,000 units of polymyxin B (c) Conditions of use—(1) Indications sulfate, and10 mg of hydrocortisone. for use. For dogs for the treatment of (b) Sponsors. See Nos. 000061 and generalized demodicosis (Demodex 043264 in § 510.600(c) of this chapter. canis). (c) Conditions of use in dogs and cats.— (2) Amount. One 10.6 milliliter bottle (1) Amount. Apply a thin film over the per 2 gallons of warm water (250 parts cornea three or four times daily. per million) for each treatment, for a (2) Indications for use. For treating total of 3 to 6 treatments, 14 days acute or chronic conjunctivitis caused apart. by susceptible organisms.

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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. [57 FR 37333, Aug. 18, 1992, as amended at 61 [40 FR 48128, July 18, 1980, as amended at 79 FR 8873, Mar. 6, 1996; 62 FR 61626, Nov. 19, FR 10967, Feb. 27, 2014] 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014] § 524.463 Copper naphthenate. (a) Amount. The drug is a 37.5 percent § 524.390 Chloramphenicol ophthalmic ointment. solution of copper naphthenate. (b) Sponsors. See Nos. 017135, 054771, (a) Specifications. Each gram contains and 058829 in § 510.600(c) of this chapter. 10 milligrams chloramphenicol. (c) Conditions of use in horses—(1) (b) Sponsors. See Nos. 043264 and Amount. Apply daily to affected hooves 054771 in § 510.600(c) of this chapter. until fully healed. (c) Conditions of use in dogs and cats— (2) Indications for use. As an aid in (1) Amount. Apply every 3 hours around treating horses and ponies for thrush the clock for 48 hours, after which caused by organisms susceptible to night instillations may be omitted. copper naphthenate. (2) Indications for use. For treatment (3) Limitations. Use on horses and of bacterial conjunctivitis caused by ponies only. Avoid contact around pathogens susceptible to chloramphen- eyes. Do not contaminate feed. Do not icol. use in horses intended for human con- (3) Limitations. Federal law restricts sumption. this drug to use by or on the order of a licensed veterinarian. Federal law pro- [47 FR 4250, Jan. 29, 1982, as amended at 68 hibits the use of this drug in food-pro- FR 55825, Sept. 29, 2003; 71 FR 38074, July 5, ducing animals. 2006; 79 FR 10967, Feb. 27, 2014] [77 FR 4897, Feb. 1, 2012, as amended at 77 FR § 524.575 Cyclosporine ophthalmic 64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014] ointment. (a) Specifications. Each gram of oint- § 524.402 Chlorhexidine. ment contains 2 milligrams of (a) Specifications. Each gram of oint- cyclosporine. ment contains 10 milligrams (b) Sponsor. See No. 000061 in chlorhexidine acetate. § 510.600(c) of this chapter. (b) Sponsors. See Nos. 054771 and (c) Conditions of use—(1) Amount. 058829 in § 510.600(c) of this chapter. Apply a 1⁄4-inch strip of ointment di- (c) Conditions of use in dogs, cats, and rectly on the cornea or into the con- horses—(1) Indications for use. For use junctival sac of the affected eye(s) as a topical antiseptic ointment for every 12 hours. surface wounds. (2) Indications for use. For manage- (2) Limitations. Do not use in horses ment of chronic keratoconjunctivitis intended for human consumption. sicca (KCS) and chronic superficial [72 FR 265, Jan. 4, 2007, as amended at 79 FR keratitis (CSK) in dogs. 10967, Feb. 27, 2014] (3) Limitations. Federal law restricts this drug to use by or on the order of a § 524.450 Clotrimazole. licensed veterinarian. (a) Specifications. Each gram of cream [60 FR 48651, Sept. 20, 1995, as amended at 62 contains 10 milligrams of clotrimazole. FR 48940, Sept. 18, 1997; 79 FR 10967, Feb. 27, (b) Sponsors. See No. 000859 in 2014] § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. § 524.590 Diclofenac. Apply 1⁄4-inch ribbon of cream per (a) Specifications. Each gram of cream square inch of lesion once daily for 2 to contains 10 milligrams diclofenac so- 4 weeks. dium. (2) Indications of use. For the treat- (b) Sponsor. See No. 000010 in ment of fungal infections of dogs and § 510.600(c) of this chapter. cats caused by Microsporum canis and (c) Conditions of use in horses—(1) Trichophyton mentagrophytes. Amount. Apply a 5-inch (5″) ribbon of

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cream twice daily over the affected gle dose 0.5 mg (1 mL) per kilogram (1 joint for up to 10 days and rub thor- mL per 22 pounds) body weight. oughly into the hair covering the joint (2) Indications for use. For treatment until it disappears. and control of gastrointestinal (2) Indications for use in horses. For roundworms: Ostertagia ostertagi (adults the control of pain and inflammation and fourth-stage larvae), Ostertagia associated with osteoarthritis in tar- ostertagi (inhibited fourth-stage lar- sal, carpal, metacarpophalangeal, vae), Ostertagia lyrata (adults), metatarsophalangeal, and proximal Haemonchus placei (adults and fourth- interphalangeal (hock, knee, fetlock stage larvae), Trichostrongylus axei and pastern) joints. (adults and fourth-stage larvae), (3) Limitations. Do not use in horses Trichostrongylus colubriformis (adults intended for human consumption. Fed- and fourth-stage larvae), Cooperia eral law restricts this drug to use by or oncophora (adults and fourth-stage lar- on the order of a licensed veterinarian. vae), Cooperia punctata (adults and [69 FR 40767, July 7, 2004, as amended at 74 fourth-stage larvae), Cooperia pectinata FR 26782, June 4, 2009; 74 FR 47436, Sept. 16, (adults), Cooperia surnabada (adults), 2009] Bunostomum phlebotomum (adults), § 524.660 Dimethyl sulfoxide. Oesophagostomum radiatum (adults and fourth-stage larvae), Trichuris spp. (a) Specifications—(1) Each milliliter (adults); lungworms: Dictyocaulus (mL) of solution contains 90 percent di- viviparus (adults and fourth-stage lar- methyl sulfoxide and 10 percent water. vae); eyeworms: Thelazia gulosa (2) Each milliliter (mL) of gel prod- (adults), Thelazia skrjabini (adults); uct contains 90 percent dimethyl sulf- grubs: Hypoderma bovis and Hypoderma oxide. lineatum; sucking lice: Linognathus (b) Sponsor. See No. 054771 in vituli, Haematopinus eurysternus, and § 510.600(c) of this chapter. Solenopotes capillatus; biting lice: (c) Conditions of use in horses and dogs—(1) Amount—(i) Horses. Apply Bovicola (Damalinia) bovis; mange topically two to three times daily in an mites: Chorioptes bovis and Sarcoptes amount not to exceed 100 mL per day. scabiei; horn flies: Haematobia irritans; Total duration of therapy should not and to control infections and to protect exceed 30 days. from reinfection with Cooperia (ii) Dogs. Apply topically three to oncophora, Dictyocaulus viviparus, four times daily in an amount not to Ostertagia ostertagi, and exceed 20 mL per day. Total duration of Oesophagostomum radiatum for 28 days; therapy should not exceed 14 days. and with Cooperia punctata and (2) Indications for use. To reduce acute Haemonchus placei for 35 days after swelling due to trauma. treatment; and to control infestations (3) Limitations. Do not use in horses and to protect from reinfestation with intended for human consumption. Fed- Linognathus vituli for 42 days and with eral law restricts this drug to use by or Bovicola (Damalinia) bovis for 77 days on the order of a licensed veterinarian. after treatment. (3) Limitations. Do not slaughter cat- [79 FR 10967, Feb. 27, 2014] tle within 45 days of latest treatment. § 524.770 Doramectin. This product is not approved for use in female dairy cattle 20 months of age or (a) Specifications. Each milliliter older, including dry dairy cows. Use in (mL) of solution contains 5 milligrams these cattle may cause drug residues in (mg) doramectin. milk and/or in calves born to these (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. cows. A withdrawal period has not been (c) Related tolerances. See § 556.225 of established for this product in this chapter. preruminating calves. Do not use in (d) Special considerations. See § 500.25 calves to be processed for veal. of this chapter. [69 FR 48392, Aug. 10, 2004, as amended at 70 (e) Conditions of use in cattle—(1) FR 43046, July 26, 2005; 79 FR 10967, Feb. 27, Amount. Administer topically as a sin- 2014]

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§ 524.775 Emodepside and (d) Special considerations. See § 500.25 praziquantel. of this chapter. (a) Specifications. Each milliliter of (e) Conditions of use in cattle—(1) solution contains 21.4 milligrams (mg) Amount. Apply 5 mg (1 mL) per 10 kilo- emodepside and 85.7 mg praziquantel. grams (kg) of body weight (500 (b) Sponsor. See No. 000859 in micrograms/kg) applied topically along § 510.600(c) of this chapter. backbone from withers to tailhead. (c) Conditions of use in cats—(1) (2) Indications for use. For treatment Amount. The recommended minimum and control of gastrointestinal dose is 1.36 mg/pound (lb) (3 mg/kilo- roundworms (Haemonchus placei (adult gram (kg)) emodepside and 5.45 mg/lb and L4), Ostertagia ostertagi (adult and (12 mg/kg) praziquantel applied as a L4, including inhibited L4), single topical dose. Trichostrongylus axei (adult and L4), T. (2) Indications for use. For the treat- colubriformis (adult and L4), T. ment and control of hookworm infec- longispicularis (adult), Cooperia oncophora (adult and L4), C. punctata tions caused by Ancylostoma tubaeforme (adult and L4), C. surnabada (adult and (adults, immature adults, and fourth L4), Nematodirus helvetianus (adult and stage larvae), roundworm infections L4), Bunostomum phlebotomum (adult caused by Toxocara cati (adults and and L4), Oesophagostomum radiatum fourth stage larvae), and tapeworm in- (adult and L4), Strongyloides papillosus fections caused by Dipylidium caninum (adults), Trichuris spp. (adults)); (adults) and Taenia taeniaeformis lungworms (Dictyocaulus viviparus, (adults). adult and L4); cattle grubs (all para- (3) Limitations. Federal law restricts sitic stages Hypoderma lineatum, H. this drug to use by or on the order of a bovis); lice (Damalinia bovis, licensed veterinarian. Linognathus vituli, Haematopinus [72 FR 42291, Aug. 2, 2007] eurysternus, Solenopotes capillatus); mange mites (Chorioptes bovis, Sarcoptes § 524.802 Enrofloxacin and silver sulfa- scabiei); and horn flies (Haematobia diazine otic emulsion. irritans). Controls and protects from re- (a) Specifications. Each milliliter con- infection of D. viviparus for 21 days tains 5 milligrams (mg) enrofloxacin after treatment and H. irritans for 7 and 10 mg silver sulfadiazine. days after treatment. (b) Sponsor. See No. 000859 in (3) Limitations. A withdrawal period § 510.600(c) of this chapter. has not been established for (c) Conditions of use—Dogs—(1) preruminating calves. Do not use in Amount. 5 to 10 drops for dogs weighing calves to be processed for veal. 35 pounds (lb) or less and 10 to 15 drops [76 FR 72619, Nov. 25, 2011] for dogs weighing more than 35 lb; applied twice daily for up to 14 days. § 524.900 Famphur. (2) Indications for use. For the treat- (a) Specifications. The drug is in liquid ment of otitis externa in dogs. form containing 13.2 percent famphur. (3) Limitations. Federal law restricts (b) Sponsor. See Nos. 000061 and 051311 this drug to use by or on the order of a in § 510.600(c) of this chapter. licensed veterinarian. Federal law pro- (c) Special considerations. Do not use hibits the extralabel use of this drug in on animals simultaneously or within a food-producing animals. few days before or after treatment with [65 FR 66620, Nov. 7, 2000, as amended at 79 or exposure to cholinesterase-inhib- FR 10967, Feb. 27, 2014] iting drugs, pesticides, or chemicals. (d) Related tolerances. See § 556.273 of § 524.814 Eprinomectin. this chapter. (a) Specifications. Each milliliter (e) Conditions of use—(1) Amount. (mL) contains 5 milligrams (mg) of Apply 1 ounce per 200 pounds body eprinomectin. weight, not to exceed a total dosage of (b) Sponsor. See No. 050604 in 4 ounces, from the shoulder to the tail § 510.600(c) of this chapter. head as a single treatment. Apply as (c) Related tolerances. See § 556.227 of soon as possible after heel fly activity this chapter. ceases.

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(2) Indications for use in beef and non- (b) Sponsor. See sponsors in lactating dairy cattle. For control of cat- § 510.600(c) of this chapter: tle grubs and to reduce cattle lice in- (1) No. 000859 for use of product de- festations. scribed in paragraph (a)(1)(i) as in para- (3) Limitations. Do not slaughter with- graph (d)(1) of this section. in 35 days after treatment. Do not use (2) No. 000859 for use of product de- on lactating dairy cows or dry dairy scribed in paragraph (a)(1)(ii) as in cows within 21 days of freshening, paragraph (d)(2) of this section. calves less than 3 months old, animals (3) No. 000859 for use of products de- stressed from castration, overexcite- scribed in paragraph (a)(2) as in para- ment or dehorning, sick or convales- graph (d)(3) of this section. cent animals. Animals may become de- (c) Related tolerances. See 40 CFR hydrated and under stress following 180.214. shipment. Do not treat until they are (d) Conditions of use—(1) Beef cattle in good condition. Brahman and Brah- and nonlactating dairy cattle—(i) man crossbreeds are less tolerant of Amount. It is used at the rate of one- cholinesterase-inhibiting insecticides half fluid ounce per 100 pounds of body than other breeds. Do not treat Brah- weight applied topically on the man bulls. Swine should be eliminated backline of the animal. Only one appli- from area where runoff occurs. cation per season should be made for [40 FR 13873, Mar. 27, 1975, as amended at 49 grub control and this will also provide FR 34352, Aug. 30, 1984; 57 FR 7652, Mar. 4, initial control of lice. A second appli- 1992; 59 FR 28769, June 3, 1994; 62 FR 55161, cation for lice control may be made if Oct. 23, 1997; 62 FR 61626, Nov. 19, 1997; 69 FR animals become reinfested, but no 41427, July 9, 2004; 79 FR 10968, Feb. 27, 2014] sooner than 35 days after the first treatment. Proper timing of treatment § 524.916 Fentanyl. is important for grub control; cattle (a) Specifications. Each milliliter of should be treated as soon as possible solution contains 50 milligrams (mg) after heel-fly activity ceases. fentanyl. (ii) Indications for use. For the control (b) Sponsor. See No. 000986 in of grubs and lice in beef and nonlac- § 510.600(c) of this chapter. tating cattle. (c) Conditions of use—(1) Dogs—(i) (iii) Limitations. Do not use on ani- Amount. 1.2 mg/lb (2.7 mg/kg) applied mals simultaneously or within a few topically to the dorsal scapular area 2 days before or after treatment with or to 4 hours prior to surgery. exposure to cholinesterase-inhibiting (ii) Indications for use. For the control drugs, pesticides, or chemicals. Cattle of postoperative pain associated with should not be slaughtered within 35 surgical procedures in dogs. days following a single treatment. If a (iii) Limitations. Fentanyl is a Class II second application is made for lice con- controlled substance. Observe all trol, cattle should not be slaughtered ‘‘black-box warnings’’ on product label- within 45 days of the second treatment. ing. Federal law restricts this drug to The drug must not be used within 28 use by or on the order of a licensed vet- days of freshening of dairy cattle. If erinarian. freshening should occur within 28 days (2) [Reserved] after treatment, do not use milk as [77 FR 47512, Aug. 9, 2012, as amended at 78 human food for the balance of the 28- FR 44433, July 24, 2013] day interval. Do not treat lactating dairy cattle; calves less than 3 months § 524.920 Fenthion. old; or sick, convalescent, or stressed (a) Specifications. (1) The drug is a liq- livestock. Do not treat cattle for 10 uid containing: days before or after shipping, weaning, (i) 3 percent of fenthion; or or dehorning or after exposure to con- (ii) 20 percent fenthion. tagious infectious diseases. (2) The drug is a solution containing (2) Beef cattle and dairy cattle not of either 5.6 or 13.8 percent fenthion. Each breeding age—(i) Amount. It is adminis- concentration is available in 2 volumes tered as a single, topical application which are contained in single-dose ap- placed on the backline of animals as plicators. follows: For animals weighing 150 to

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300 pounds, apply 4 milliliters (mL); for (ii) Indications for use. For flea con- animals weighing 301 to 600 pounds, trol on dogs only. apply 8 mL; for animals weighing 601 to (iii) Limitations. Federal law restricts 900 pounds, apply 12 mL; for animals this drug to use by or on the order of a weighing 901 to 1,200 pounds, apply 16 licensed veterinarian. mL; and for animal weighing over 1,200 pounds, apply 20 mL. For most effec- [79 FR 10968, Feb. 27, 2014] tive results, cattle should be treated as § 524.960 Flumethasone, neomycin, soon as possible after heel-fly activity and polymyxin B ophthalmic solu- ceases. A second application is required tion. for animals heavily infested with lice (a) Specifications. Each milliliter of or for those which become reinfested. A ophthalmic preparation contains 0.10 second application should be made no milligram flumethasone, 5.0 milligrams sooner than 35 days after the first neomycin sulfate (3.5 milligrams neo- treatment. mycin base), and 10,000 units of poly- (ii) Indications for use. For control of myxin B sulfate, with or without cattle grubs and as an aid in control- hydroxypropyl methylcellulose. ling lice on beef cattle and on dairy (b) Sponsor. See No. 054771 in cattle not of breeding age. § 510.600(c) of this chapter. (iii) Limitations. Do not use on animals simultaneously or within a few (c) Conditions of use—(1) Amount—(i) days before or after treatment with or Preparation containing hydroxypropyl exposure to cholinesterase-inhibiting methylcellulose. Dogs: 1 to 2 drops per drugs, pesticides, or chemicals. Host- eye, every 6 hours. parasite reactions such as bloat, saliva- (ii) Preparation without hydroxyproply tion, staggering and paralysis may methylcellulose. Dogs and cats: 2 to 3 sometimes occur when cattle are treat- drops per eye, every 4 hours. ed while the common cattle grub (2) Indications for use. Treatment of (Hypoderma lineatum) is in the gullet, the inflammation, edema, and sec- or while the northern cattle grub (H. ondary bacterial infections associated bovis) is in the area of the spinal cord. with topical ophthalmological condi- Cattle should be treated before these tions of the eye such as corneal inju- stages of grub development. Consult ries, incipient pannus, superficial kera- your veterinarian, extension livestock titis, conjunctivitis, acute specialist, or extension entomologist nongranulomatous anterior uveitis, regarding the timing of treatment. If it keratoconjunctivitis, and blepharitis. is impossible to determine the area (3) Limitations. Federal law restricts from which the cattle came and/or this drug to use by or on the order of a exact stage of the grubs, it is rec- licensed veterinarian. ommended that the cattle receive only [44 FR 16012, Mar. 16, 1979, as amended at 61 a maintenance ration of low-energy FR 5507, Feb. 13, 1996; 79 FR 10968, Feb. 27, feed during the treatment period. This 2013] lessens the likelihood of severe bloat which may occur in cattle on full feed § 524.981 [Reserved] when the common grub is killed while in the gullet. Do not treat dairy cattle § 524.981a Fluocinolone cream. of breeding age; calves less than 3 (a) Specifications. The drug contains months old; sick, convalescent, or se- 0.025 percent fluocinolone acetonide. verely stressed livestock. Do not treat (b) Sponsor. See No. 099207 in cattle for 10 days before or after ship- § 510.600(c) of this chapter. ping, weaning, dehorning, or after ex- (c) Conditions of use in dogs—(1) posure to contagious or infectious dis- Amount—A small amount is applied to eases. Do not slaughter within 45 days the affected area two or three times of treatment. daily. (3) Dogs—(i) Amount. Four to 8 milli- (2) Indications for use. For the relief of grams per kilogram of body weight. pruritis and inflammation associated Apply the contents of the proper size, with certain superficial acute and single-dose tube directly to one spot on chronic dermatoses. It is used in the the dog’s skin. treatment of allergic and acute moist

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dermatitis and for the relief of super- (3) Federal law restricts this drug to ficial inflammation caused by chemical use by or on the order of a licensed vet- burns and physical abrasions. erinarian. (3) Federal law restricts this drug to [40 FR 13873, Mar. 27, 1975, as amended at 62 use by or on the order of a licensed vet- FR 40932, July 31, 1997; 79 FR 10969, Feb. 27, erinarian. 2014] [40 FR 13873, Mar. 27, 1975, as amended at 62 § 524.981d Fluocinolone and dimethyl FR 40932, July 31, 1997; 79 FR 10968, Feb. 27, sulfoxide solution. 2014] (a) Specifications. Each milliliter of § 524.981b Fluocinolone solution. solution contains 0.01 percent fluocinolone acetonide and 20 percent (a) Specifications. The drug contains dimethyl sulfoxide. 0.01 percent fluocinolone acetonide. (b) Sponsor. See No. 054771 in (b) Sponsor. See No. 099207 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) (c) Conditions of use in dogs—(1) Amount—Instill 1 to 2 milliliters into Amount—A small amount of solution is each anal sac following expression of applied to the affected area two or anal sac contents. three times daily. (2) Indications for use. For the relief of (2) Indications for use—(i) Dogs. For impaction commonly present in appar- the relief of pruritis and inflammation ently normal anal sacs, for the reversal associated with otitis externa and cer- of inflammatory changes associated with abnormal anal sacs, and to coun- tain superficial acute and chronic teract the offensive odor of anal sac se- dermatoses. cretions. (ii) Cats. For the relief of pruritis and (3) Limitations. Federal law restricts inflammation associated with acute this drug to use by or on the order of a otitis externa and certain superficial licensed veterinarian. acute and chronic dermatoses. (3) Federal law restricts this drug to [79 FR 10969, Feb. 27, 2014] use by or on the order of a licensed vet- § 524.981e Fluocinolone and dimethyl erinarian. sulfoxide otic solution. [40 FR 13873, Mar. 27, 1975, as amended at 62 (a) Specifications. Each milliliter of FR 40932, July 31, 1997; 79 FR 10969, Feb. 27, solution contains 0.01 percent 2014] fluocinolone acetonide and 60 percent dimethyl sulfoxide. § 524.981c Fluocinolone and neomycin (b) Sponsor. See No. 054771 in cream. § 510.600(c) of this chapter. (a) Specifications. The drug contains (c) Conditions of use in dogs—(1) 0.025 percent fluocinolone acetonide Amount—Instill 4 to 6 drops (0.2 milli- and 0.5 percent neomycin sulfate (0.35 liter) twice daily into the ear canal for percent neomycin base). a maximum period of 14 days. The total (b) Sponsor. See No. 099207 in dosage used should not exceed 17 milli- § 510.600(c) of this chapter. liters. (2) Indications for use. For the relief of (c) Conditions of use in dogs—(1) pruritis and inflammation associated Amount—A small amount is applied to with acute and chronic otitis. the affected area two or three times (3) Limitations. Federal law restricts daily. this drug to use by or on the order of a (2) Indications for use—(i) Dogs. For licensed veterinarian. the relief of pruritis and inflammation associated with superficial acute and [79 FR 10969, Feb. 27, 2014] chronic dermatoses. It is used in the § 524.1005 Furazolidone powder. treatment of allergic and acute moist (a) The product con- dermatitis and nonspecific dermatoses. Specifications. tains either 4 or 10 percent furazolidone (ii) Dogs and cats. Used in the treat- in inert dispersing agent and propel- ment of wound infections. lant.

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(b) Sponsors. (1) See No. 054771 in (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter for use as in § 510.600(c) of this chapter. paragraphs (c)(1), (c)(2)(i), (c)(2)(ii), and (c) Conditions of use. (1) The drug is (c)(3) of this section. used in dogs and cats for the topical (2) See No. 017135 for use of the 4 per- treatment of infections of the con- cent product as in paragraph (c)(2)(iv) junctiva caused by susceptible bac- of this section. teria. (c) Conditions of use—(1) Amount. Hold (2) Administer 1 or 2 drops into the container about 6 to 12 inches from the conjunctival sac 2 to 4 times a day. eye or affected area and apply only (3) Federal law restricts this drug to enough powder to impart a light yellow use by or on the order of a licensed vet- color. erinarian. (2) Indications of use—(i) Dogs. For treatment or prevention of bacterial [41 FR 14189, Apr. 2, 1976, as amended at 52 infection of superficial wounds, abra- FR 7832, Mar. 13, 1987] sions, lacerations, and pyogenic derma- § 524.1044b Gentamicin and titis. betamethasone otic solution. (ii) Horses. For treatment or prevention of bacterial infection of superficial (a) Specifications. Each milliliter of wounds, abrasions, lacerations, and fol- solution contains gentamicin sulfate lowing firing (heat or electrocautery). equivalent to 3 milligrams (mg) (iii) [Reserved] gentamicin base and betamethasone (iv) Horses and ponies. For treatment valerate equivalent to 1 mg or prevention of bacterial infection of betamethasone alcohol. superficial wounds, abrasions, and lac- (b) Sponsors. See Nos. 000061 and erations caused by Staphylococcus 054925 in § 510.600(c) of this chapter. aureus, Streptococcus spp. and Proteus (c) Conditions of use—(1) Amounts and spp. sensitive to furazolidone. indications for use—(i) For the treat- (3) Limitations. For topical applica- ment of acute and chronic otitis tion in horses, ponies, and dogs: Clean externa caused by bacteria sensitive to affected area thoroughly, apply drug gentamicin in dogs, instill three to 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 [71 FR 13542, Mar. 16, 2006] use in horses intended for human consumption. § 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, (a) Specifications. Each gram of oint- 1991; 57 FR 31314, July 15, 1992; 60 FR 55659, ment contains gentamicin sulfate Nov. 2, 1995; 65 FR 41588, July 6, 2000; 79 FR equivalent to 3 milligrams of 10969, Feb. 27, 2014] gentamicin. § 524.1044 Gentamicin ophthalmic and (b) Sponsors. See Nos. 000061 and topical dosage forms. 043264 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— § 524.1044a Gentamicin ophthalmic so- (1) Amount. Apply approximately a 1/2- lution. inch strip to the affected eye 2 to 4 (a) Specifications. Each milliliter of times a day. sterile aqueous solution contains (2) Indications for use. For treatment gentamicin sulfate equivalent to 3 mil- of conjunctivitis caused by susceptible ligrams of gentamicin. bacteria.

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(3) Limitations. Federal law restricts increases, discontinue use and consult this drug to use by or on the order of a a veterinarian. licensed veterinarian. [48 FR 41157, Sept. 14, 1983, as amended 52 FR [69 FR 47363, Aug. 5, 2004, as amended at 77 7833, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2014] FR 64717, Oct. 23, 2012] § 524.1044f Gentamicin and § 524.1044d Gentamicin and betamethasone spray. betamethasone ointment. (a) Specifications. Each milliliter of (a) Specifications. Each gram of oint- spray contains gentamicin sulfate ment contains gentamicin sulfate equivalent to 0.57 milligram (mg) equivalent to 3 milligrams of gentamicin base and betamethasone gentamicin base and betamethasone valerate equivalent to 0.284 mg valerate equivalent to 1 milligram of betamethasone. betamethasone. (b) Sponsors. See Nos. 000061, 054925, (b) Sponsor. See No. 000061 in 058005, 058829, and 065531 in § 510.600(c) of § 510.600(c) of this chapter. this chapter. (c) Conditions of use in dogs—(1) (c) Conditions of use in dogs—(1) Amount—(i) Otitis externa. Instill 3 to 8 Amount. Hold bottle upright 3 to 6 drops into the ear canal twice daily for inches from the lesion and depress the 7 days. sprayer head twice. Administer two (ii) Infected superficial lesions. Apply spray actuations two to four times to cover the treatment area twice daily daily for 7 days. for 7 to 14 days. (2) Indications for use. For the treat- (2) Indications for use. For the treatment of infected superficial lesions ment of acute and chronic otitis caused by bacteria susceptible to externa and infected superficial lesions gentamicin. caused by bacteria sensitive to (3) Limitations. Federal law restricts gentamicin. this drug to use by or on the order of a licensed veterinarian. (3) Limitations. Federal law restricts this drug to use by or on the order of a [71 FR 13542, Mar. 16, 2006, as amended at 72 licensed veterinarian. FR 5929, Feb. 8, 2007; 74 FR 22822, May 15, 2009; 77 FR 3598, Jan. 25, 2012] [47 FR 26378, June 18, 1982, as amended at 52 FR 7832, Mar. 13, 1987; 79 FR 10969, Feb. 27, § 524.1044g Gentamicin, 2014] betamethasone, and clotrimazole ointment. § 524.1044e Gentamicin spray. (a) Specifications. Each gram (g) of (a) Specification. Each milliliter of ointment contains gentamicin sulfate sterile aqueous solution contains equivalent to 3 milligrams (mg) gentamicin sulfate equivalent to 1.07 gentamicin base, betamethasone val- milligrams of gentamicin. erate equivalent to 1 mg (b) Sponsor. See No. 000061 in betamethasone, and 10 mg § 510.600(c) of this chapter. clotrimazole. (c) Conditions of use in cattle—(1) (b) Sponsors. See sponsors in Amount. Hold the sprayer upright 3 to 6 § 510.600(c) of this chapter for uses as in inches from the affected eye, with the paragraph (c) of this section. opening directed towards the eye, and (1) No. 000061 for use of 7.5- or 15-gram pump once. Treat once daily for up to (g) tubes, 12.5-, 30-, or 215-g bottles. 3 days. (2) No. 054925 for use of 7.5- or 15-g (2) Indications for use. For the treat- tubes; 10-, 15-, 25-, or 215-g bottles. ment of pinkeye in cattle (infectious (3) No. 000859 for use of 10-, 20-, 40-, or bovine keratoconjunctivitis) caused by 215-g bottles. Moraxella bovis. (4) No. 025463 for use of 7.5- or 15-g (3) Limitations. Conditions other than tubes, or 215-g bottles. bacterial infections of the bovine eye (c) Conditions of use in dogs—(1) and infectious keratoconjunctivitis Amount. Instill ointment twice daily caused by Moraxella bovis may produce into the ear canal for 7 consecutive similar signs. If conditions persists or days.

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(i) From 7.5- or 15-g tubes; 10-, 12.5-, (3) Limitations. Federal law restricts 15-, 25-, or 30-g bottles: 4 drops for dogs this drug to use by or on the order of a weighing less than 30 pounds (lb) or 8 licensed veterinarian. drops for dogs weighing 30 lb or more. [66 FR 712, Jan. 4, 2001, as amended at 68 FR (ii) From 20-, 40-, or 215-g bottles: 2 15370, Mar. 31, 2003; 70 FR 36338, June 23, 2005; drops for dogs weighing less than 30 lb 79 FR 10969, Feb. 27, 2014] or 4 drops for dogs weighing 30 lb or more. § 524.1044i Gentamicin and betamethasone ophthalmic solution. (ii) From 20- or 215-g bottles: 2 drops for dogs weighing less than 30 lb or 4 (a) Specifications. Each milliliter drops for dogs weighing 30 lb or more. (mL) of solution contains gentamicin (2) Indications for use. For the treat- sulfate equivalent to 3 milligrams (mg) ment of acute and chronic canine otitis of gentamicin base and 1 mg externa associated with yeast betamethasone acetate equivalent to 0.89 mg betamethasone alcohol. (Malassezia pachydermatis, formerly (b) Sponsor. See No. 000061 in Pityrosporum canis) and/or bacteria sus- § 510.600(c) of this chapter. ceptible to gentamicin. (c) Conditions of use in dogs—(1) (3) Limitations. Federal law restricts Amount. Instill one or two drops of so- this drug to use by or on the order of a lution in the conjunctival sac three or licensed veterinarian. four times a day. [58 FR 38973, July 21, 1993, as amended at 63 (2) Indications for use. For treatment FR 31932, June 11, 1998; 68 FR 42970, July 21, of external bacterial infections of the 2003; 70 FR 8291, Feb. 18, 2005; 71 FR 13542, eye (conjunctiva and cornea). Mar. 16, 2006; 71 FR 16481, Apr. 3, 2006; 71 FR (3) Limitations. Federal law restricts 38261, July 6, 2006; 71 FR 56867, Sept. 28, 2006; this drug to use by or on the order of a 78 FR 17597, Mar. 22, 2013; 79 FR 10969, Feb. 27, licensed veterinarian. 2014] [75 FR 54492, Sept. 8, 2010] § 524.1044h Gentamicin, mometasone, and clotrimazole otic suspension. § 524.1132 Hydrocortisone, miconazole, and gentamicin otic suspension. (a) Specifications. Each gram contains (a) Specifications. Each milliliter gentamicin sulfate, United States (mL) of suspension contains 1.11 milli- Pharmacopeia (USP) equivalent to 3 grams (mg) of hydrocortisone milligram (mg) gentamicin base, aceponate, 15.1 mg of miconazole ni- mometasone furoate monohydrate trate, and 1,505 micrograms of equivalent to 1 mg mometasone, and 10 gentamicin sulfate. mg clotrimazole, USP. (b) Sponsor. See No.051311 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—(1) (c) Conditions of use in dogs—(1) Amount. Instill 1.0 mL in the affected Amount. For dogs weighing less than 30 ear once daily for 5 days. pounds (lb), instill 4 drops from the 7.5- (2) Indications for use. For the treat- , 15-, or 30-gram (g) bottle into the ear ment of otitis externa in dogs associ- canal (2 drops from the 215-g bottle) or, ated with susceptible strains of yeast for dogs weighing 30 lb or more, instill (Malassezia pachydermatis) and bacteria 8 drops from the 7.5-, 15-, or 30-g bottle (Staphylococcus pseudintermedius). into the ear canal (4 drops from the 215- (3) Limitations. Federal law restricts g bottle), once or twice daily for 7 days. this drug to use by or on the order of a (2) Indications for use. For the treat- licensed veterinarian. ment of otitis externa caused by sus- [76 FR 78150, Dec. 16, 2011] ceptible strains of yeast (Malassezia pachydermatis) and bacteria § 524.1140 Imidacloprid and (Pseudomonas spp. [including P. ivermectin. aeruginosa], coagulase-positive (a) Specifications. The product is staphylococci, Enterococcus faecalis, available in unit applicator tubes con- Proteus mirabilis, and beta-hemolytic taining 0.4, 1.0, 2.5, or 4.0 milliliters streptococci). (mL). Each mL of solution contains 100

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milligrams (mg) imidacloprid and 800 imidacloprid and 0.45 mg/lb (1.0 mg/kg) micrograms (μg) ivermectin. moxidectin, once a month. (b) Sponsor. See No. 000859 in (ii) Indications for use. For the pre- § 510.600(c) of this chapter. vention of heartworm disease caused (c) Conditions of Use in Dogs—(1) by Dirofilaria immitis; for the treatment Amount. The recommended minimum and control of ear mite (Otodectes dosage is 4.5 mg/pound (lb) (10 mg/kilo- cynotis) infestations, intestinal gram (kg)) of imidacloprid and 36.4 μg/ roundworms (Toxocara cati), and lb (80 μg/kg) of ivermectin, topically hookworms (Ancylostoma tubaeforme); once a month. kills adult fleas and treats flea infesta- (2) Indications for Use. For the preven- tions (Ctenocephalides felis). tion of heartworm disease caused by (3) Ferrets—(i) Amount. Topically Dirofilaria immitis; kills adult fleas and apply 9.0 mg/lb body weight (20 mg/kg) is indicated for the treatment of flea imidacloprid and 0.9 mg/lb (2 mg/kg) infestations (Ctenocephalides felis). moxidectin, once a month. (3) Limitations. Federal law restricts (ii) Indications for use. For the pre- this drug to use by or on the order of a vention of heartworm disease caused licensed veterinarian. by Dirofilaria immitis; kills adult fleas (Ctenocephalides felis) and is indicated [67 FR 78685, Dec. 26, 2002] for the treatment of flea infestations on ferrets. § 524.1146 Imidacloprid and moxidectin. [72 FR 10597, Mar. 9, 2007, as amended at 78 FR 73698, Dec. 9, 2013] (a) Specifications—(1) Each milliliter of solution contains 100 milligrams § 524.1193 Ivermectin topical solution. (mg) imidacloprid and 25 mg (a) Specifications. Each milliliter moxidectin for use as in paragraph (mL) of solution contains 5 milligrams (d)(1) of this section. of ivermectin. (2) Each milliliter of solution con- (b) Sponsors. See sponsors in tains 100 mg imidacloprid and 10 mg § 510.600(c) of this chapter for use as in moxidectin for use as in paragraphs paragraph (e) of this section. (d)(2) and (d)(3) of this section. (1) Nos. 050604, 055529, 058829, 061623 (b) Sponsor. See No. 000859 in for use as in paragraphs (e)(1), (e)(2)(i), § 510.600(c) of this chapter. (e)(2)(iii), and (e)(3) of this section. (c) Special considerations. Federal law (2) Nos. 000859, 054925, and 086001 for restricts this drug to use by or on the use as in paragraphs (e)(1), (e)(2)(i), order of a licensed veterinarian. (e)(2)(ii), and (e)(3) of this section. (d) Conditions of use—(1) Dogs—(i) (c) Related tolerances. See § 556.344 of Amount. Topically apply 4.5 mg/lb body this chapter. weight (10 mg/kg) imidacloprid and 1.1 (d) Special considerations. See § 500.25 mg/lb (2.5 mg/kg) moxidectin, once a of this chapter. month. (e) Conditions of use in cattle—(1) (ii) Indications for use—(A) For the Amount. One mL per 22 pounds (0.5 mil- prevention of heartworm disease ligram per kilogram) of body weight caused by Dirofilaria immitis; and the applied topically to the back of the treatment and control of intestinal animal. roundworms (Toxocara canis and (2) Indications for use—(i) It is used Toxascaris leonina), hookworms for the treatment and control of: Gas- (Ancylostoma caninum and Uncinaria trointestinal roundworms (adults and stenocephala), and whipworms (Trichuris fourth-stage larvae) Ostertagia ostertagi vulpis); kills adult fleas and treats flea (including inhibited stage), Haemonchus infestations (Ctenocephalides felis). placei, Trichostrongylus axei, T. (B) For treatment of Dirofilaria colubriformis, Cooperia oncophora, C. immitis circulating microfilariae in punctata, C. surnabada, heartworm-positive dogs and the treat- Oesophagostomum radiatum; (adults) ment and control of sarcoptic mange Strongyloides papillosus, Trichuris spp.; caused by Sarcoptes scabiei var. canis. lungworms (adults and fourth-stage (2) Cats—(i) Amount. Topically apply larvae) Dictyocaulus viviparus; cattle 4.5 mg/lb body weight (10 mg/kg) grubs (parasitic stages) Hypoderma

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bovis, H. lineatum; mites Sarcoptes § 524.1200 Kanamycin ophthalmic and scabiei var. bovis; lice Linognathus vituli, topical dosage forms. Haematopinus eurysternus, Damalinia bovis, Solenoptes capillatus; and horn § 524.1200a Kanamycin ophthalmic flies Haematobia irritans. ointment. (ii) It controls infections and pre- (a) Specifications. Each gram of oint- vents reinfection with O. ostertagi, O. ment contains 3.5 milligrams radiatum, H. placei, T. axei, C. punctata, kanamycin activity as kanamycin sul- and C. oncophora for 14 days after fate. treatment. (b) Sponsor. See No. 054771 in (iii) It controls infections and pre- § 510.600(c) of this chapter. vents reinfection with O. radiatum and (c) Conditions of use in dogs—(1) D. viviparus for 28 days after treatment, Amount. Apply a thin film to the af- and for 21 days after C. punctata T. axei fected eye three or four times daily or treatment, O. ostertagi, H. placei, C. more frequently if deemed advisable. oncophora, and C. surnabada for 14 days Treatment should be continued for at after treatment, and D. bovis for 56 least 48 hours after the eye appears days after treatment. normal. (3) Limitations. Do not treat cattle within 48 days of slaughter. Because a (2) Indications for use. For the treat- withdrawal time in milk has not been ment of various eye infections (con- established, do not use in female dairy junctivitis, blepharitis, dacryocystitis, cattle of breeding age. A withdrawal keratitis, and corneal ulcerations) due period has not been established for this to bacteria sensitive to kanamycin. product on preruminating calves. Do For prophylaxis in traumatic condi- not use on calves to be processed for tions, removal of foreign bodies, and veal. intraocular surgery. (3) Limitations. Federal law restricts [55 FR 50551, Dec. 7, 1990, as amended at 62 this drug to use by or on the order of a FR 38908, July 21, 1997; 62 FR 63271, Nov. 28, licensed veterinarian. 1997; 63 FR 44385, Aug. 19, 1998; 66 FR 13236, Mar. 5, 2001; 66 FR 63165, Dec. 5, 2001; 68 FR [79 FR 10969, Feb. 27, 2014] 3817, Jan. 27, 2003; 68 FR 4713, Jan. 30, 2003; 69 FR 501, Jan. 6, 2004; 69 FR 62181, Oct. 25, 2004; § 524.1200b Kanamycin ophthalmic so- 71 FR 13542, Mar. 16, 2006; 72 FR 6464, Feb. 12, lution. 2007; 74 FR 36112, July 22, 2009; 75 FR 26648, May 12, 2010; 76 FR 81807, Dec. 29, 2011; 78 FR (a) Specifications. Each milliliter of 17597, Mar. 22, 2013; 78 FR 63872, Oct. 25, 2013] solution contains 10 milligrams kanamycin activity as kanamycin sul- § 524.1195 Ivermectin otic suspension. fate. (a) Specifications. Each tube contains (b) Sponsor. See No. 054771 in 0.5 milliliter (mL) of a 0.01 percent sus- § 510.600(c) of this chapter. pension of ivermectin. (c) Conditions of use in dogs—(1) (b) Sponsor. See No. 000010 in Amount. Instill a few drops into the af- § 510.600(c) of this chapter. fected eye every 3 hours or more fre- (c) Conditions of use—(1) Amount. Ad- quently if deemed advisable. Admin- minister the contents of one 0.5-mL ister as frequently as possible for the tube topically into each external ear first 48 hours, after which the fre- canal. quency of applications may be de- (2) Indications for use. For the treat- creased. Treatment should be contin- ment of adult ear mite (Otodectes ued for at least 48 hours after the eye cynotis) infestations in cats and kittens appears normal. 4 weeks of age and older. Effectiveness (2) Indications for use. For the treat- against eggs and immature stages has ment of various eye infections (con- not been proven. junctivitis, blepharitis, dacryocystitis, (3) Limitations. Federal law restricts keratitis, and corneal ulcerations) due this drug to use by or on the order of a to bacteria sensitive to kanamycin. licensed veterinarian. For prophylaxis in traumatic condi- [66 FR 7578, Jan. 24, 2001, as amended at 74 tions, removal of foreign bodies, and FR 26782, June 4, 2009] intraocular surgery.

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(3) Limitations. Federal law restricts (3) Limitations. Conditions of constant this drug to use by or on the order of a helminth exposure may require re- licensed veterinarian. treatment within 2 to 4 weeks after the first treatment. Cattle must not be [79 FR 10970, Feb. 27, 2014] slaughtered within 9 days following § 524.1204 Kanamycin, amphomycin, last treatment. Do not administer to and hydrocortisone ointment. dairy animals of breeding age. Do not treat animals before dipping or prior to (a) Specifications. Each gram of ointment contains 5 milligrams kanamycin exposure to heavy rain. Consult your activity as kanamycin sulfate, 5 milli- veterinarian for assistance in the diag- grams of amphomycin activity as the nosis, treatment, and control of para- calcium salt, and 10 milligrams of hy- sitism, and before using in severely de- drocortisone acetate. bilitated animals. (b) Sponsor. See No. 054771 in [52 FR 10887, Apr. 6, 1987, as amended at 53 § 510.600(c) of this chapter. FR 7504, Mar. 9, 1988; 62 FR 61626, Nov. 19, (c) Conditions of use in dogs—(1) 1997; 67 FR 78355, Dec. 24, 2002; 79 FR 10970, Amount. Apply to the affected areas of Feb. 27, 2014] the skin at least twice daily. In severe or widespread lesions it may be desir- § 524.1376 2-Mercaptobenzothiazole solution. able to apply the ointment more than twice daily. After some improvement is (a) Specifications. The drug contains observed, treatment can usually be re- 1.3 percent 2-mercaptobenzothiazole in duced to once daily. a suitable solvent. (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 veterinarian. [79 FR 10970, Feb. 27, 2014] [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 milli- § 524.1443 Miconazole. liter of diethylene glycol monobutyl 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 chapter for use as in paragraph (c) of topically to the back of the animal. this section: (2) Indications for use. Anthelmintic (1) No. 000061 for use of cream, lotion, effective against stomach worms and spray; (Haemonchus, Trichostrongylus, (2) Nos. 054925 and 058829 for use of lo- Ostertagia), intestinal worms tion and spray. (Trichostrongylus, Cooperia, (c) Conditions of use in dogs and cats— Nematodirus, Bunostomum, (1) Amount. Apply once daily by rub- Oesophagostomum, Chabertia), and bing into or spraying a light covering lungworms (Dictyocaulus). on the infected site and the immediate

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surrounding vicinity. Continue treat- (3) Limitations. Federal law restricts ment for 2 to 4 weeks until infection is this drug to use by or on the order of a completely eradicated as determined licensed veterinarian. by appropriate laboratory examina- [65 FR 13905, Mar. 15, 2000, as amended at 66 tion. FR 13849, Mar. 8, 2001] (2) Indications for use. For topical treatment of infections caused by § 524.1450 Moxidectin. Microsporum canis, Microsporum (a) Specifications. Each milliliter con- gypseum, and Trichophyton tains 5 milligrams (mg) moxidectin (0.5 mentagrophytes. percent solution). (3) Limitations. Federal law restricts (b) Sponsor. See No. 000010 in this drug to use by or on the order of a § 510.600(c) of this chapter. licensed veterinarian. (c) Related tolerances. See § 556.426 of [71 FR 13542, Mar. 16, 2006] this chapter. (d) Special considerations. See § 500.25 § 524.1445 Miconazole, polymixin B, of this chapter. and prednisolone suspension. (e) Conditions of use–(1) Amount. Ad- (a) Specifications. Each milliliter of minister topically 0.5 mg per kilogram suspension contains 23 milligrams (mg) of body weight. miconazole nitrate, 0.5293 mg (2) Indications for use. Beef and dairy polymixin B sulfate, and 5 mg prednis- cattle: For treatment and control of in- olone acetate. ternal and external parasites: gastro- (b) Sponsor. See No. 000986 in intestinal roundworms (Ostertagia § 510.600(c) of this chapter. ostertagi (adult and L4, including inhib- (c) Conditions of use in dogs—(1) ited larvae), Haemonchus placei (adult Amount. Instill five drops in the ear and L4), Trichostrongylus axei (adult canal twice daily for 7 consecutive and L4), T. colubriformis (adult and L4), days. Cooperia oncophora (adult and L4), C. (2) Indications for use. For the treat- pectinata (adult), C. punctata (adult and ment of canine otitis externa associ- L4), C. spatulata (adult), C. surnabada ated with susceptible strains of yeast (adult and L4), Bunostomum (Malassezia pachydermatis) and bacteria phlebotomum (adult), Oesophagostomum (Staphylococcus pseudintermedius). radiatum (adult and L4), Nematodirus (3) Limitations. Federal law restricts helvetianus (adult and L4)); lungworms this drug to use by or on the order of a (Dictyocaulus viviparus, adult and L4); licensed veterinarian. cattle grubs (Hypoderma bovis, H. lineatum); mites (Chorioptes bovis, [ 75 FR 4693, Jan. 29, 2010, as amended at 77 Psoroptes ovis (P. communis var. bovis)); FR 46613, Aug. 6, 2012] lice (Linognathus vituli, Haematopinus § 524.1446 Milbemycin otic solution. eurysternus, Solenopotes capillatus, Bovicola(Damalinia) bovis); and horn (a) Specifications. Each tube contains flies (Haematobia irritans). To control 0.25 milliliter of a 0.1 percent solution infections and to protect from reinfec- of milbemycin oxime. tion with H. placei for 14 days after (b) Sponsor. See No. 058198 in treatment, O. radiatum and O. ostertagi § 510.600(c) of this chapter. for 28 days after treatment, and D. (c) Conditions of use—(1) Amount. One viviparus for 42 days after treatment. tube administered topically into each (3) Limitations. A withdrawal period external ear canal. has not been established for this prod- (2) Indications for use. For the treat- uct on preruminating calves. Do not ment of ear mite (Otodectes cynotis) in- use on calves to be processed for veal. festations in cats and kittens 4 weeks of age and older. Effectiveness is main- [63 FR 14036, Mar. 24, 1998, as amended at 65 tained throughout the life cycle of the FR 36617, June 9, 2000; 66 FR 46370, Sept. 5, ear mite. 2001. Redesignated at 76 FR 48715, Aug. 9, 2011]

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§ 524.1465 Mupirocin. moist dermatitis, and interdigital dermatitis in dogs. (a) Specifications. Each gram of oint- (3) Limitations. Federal law restricts ment contains 20 milligrams this drug to use by or on the order of a mupirocin. licensed veterinarian. (b) Sponsors. See Nos. 025463, 026637, 051672, and 054771 in § 510.600(c) of this [40 FR 13873, Mar. 27, 1975, as amended at 43 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, and tetracaine ointment. (2) Indications for use. For the topical 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 § 510.600(c) of this chapter. [72 FR 18119, Apr. 11, 2007, as amended at 75 (c) Conditions of use in dogs—(1) FR 79296, Dec. 20, 2010; 78 FR 52854, Aug. 27, Amount. In treatment of otitis externa 2013; 79 FR 10970, Feb. 27, 2014] and other inflammatory conditions of § 524.1484 Neomycin ophthalmic and the external ear canal, a quantity of topical dosage forms. ointment sufficient to fill the external 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. perficial dressing applied to minor (3) Limitations. Federal law restricts cuts, wounds, lacerations, abrasions, this drug to use by or on the order of a and for postsurgical application where licensed veterinarian. reduction of pain and inflammatory re- [40 FR 13873, Mar. 27, 1975, as amended at 43 sponse is deemed desirable; as a dust- FR 18172, Apr. 28, 1978; 79 FR 10970, Feb. 27, ing powder following amputation of 2014] tails, claws, and dewclaws and following ear trimming, castrating, and § 524.1484d Neomycin, hydrocortisone, such surgical procedures as and tetracaine otic ointment. ovariohysterectomies. For the treat- (a) Specifications. The product con- ment of acute otitis externa, acute tains 5 milligrams of neomycin sulfate,

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

§ 524.1484f Neomycin, prednisolone, § 524.1484h Neomycin, penicillin, poly- and tetracaine otic suspension. myxin B, and hydrocortisone sus- (a) Specifications. The product con- pension. tains 5 milligrams of neomycin sulfate (a) Specifications. Each milliliter of equivalent to 3.5 milligrams of neomy- suspension contains 25 milligrams of cin base, 2.5 milligrams of prednisolone neomycin sulfate equivalent to 17.5 acetate, and 5 milligrams of tetracaine milligrams of neomycin, 10,000 inter- hydrochloride in each milliliter of ster- national units of penicillin G procaine, ile suspension. 5,000 international units of polymyxin

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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 FR 10971, Feb. 27, 2014] (2) Indications for use. For the treatment of summer eczema, atopic derma- § 524.1484j Neomycin and prednisolone titis, interdigital eczema, and otitis ophthalmic ointment. externa caused by bacteria susceptible 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 those associated with allergic reactions [59 FR 5105, Feb. 3, 1994, as amended at 79 FR or gross irritants. 10971, Feb. 27, 2014] (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 [79 FR 10971, Feb. 27, 2014] milligrams of neomycin sulfate, equivalent to 3.5 milligrams of neomycin § 524.1484k Prednisolone and neomy- base, and 5 milligrams of hydro- cin suspension. cortisone acetate in each gram of oint- (a) Specifications. Each milliliter of ment.1 suspension contains 2.5 milligrams of (b) Sponsor. See No. 054771 in prednisolone acetate and 5 milligrams § 510.600(c) of this chapter. of neomycin sulfate equivalent to 3.5 (c) Conditions of use in dogs and cats— milligrams of neomycin base. (1) Amount. Apply 3 or 4 times daily (b) Sponsor. See No. 054771 in into the conjunctival sac. With im- § 510.600(c) of this chapter. provement, frequency may be reduced (c) Conditions of use in dogs and cats— to 2 or 3 times daily. For treatment of (1) Amount. For beginning treatment of ear canker and other inflammatory acute ocular inflammations place 1 or 2 conditions of the external ear canal, drops in the conjunctival sac 3 to 6 fill external ear canal 1 to 3 times times during a 24 hour period. When daily. improvement occurs, reduce the dosage

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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 No. 054628 in tivitis, acute otitis externa, and chron- § 510.600(c) of this chapter. ic otitis externa. (c) Conditions of use—(1) Amount. (3) Limitations. Federal law restricts this drug to use by or on the order of a Apply several times daily to the lesion licensed veterinarian. or affected area from the plastic squeeze bottle. [79 FR 10971, Feb. 27, 2014] (2) Indications for use. For prevention or treatment of surface bacterial infec- § 524.1580 Nitrofurazone topical dos- tions of wounds, burns, skin ulcers, and age forms. abscesses after incision. § 524.1580a Nitrofurazone ointment. (3) Limitations. In case of deep or puncture wounds or serious burns, use (a) Specifications. The drug contains only as recommended by veterinarian. 0.2 percent nitrofurazone in a water- If redness, irritation, or swelling per- soluble base. sists or increases, discontinue use; con- (b) Sponsors. See sponsors in sult veterinarian. For use only on dogs, § 510.600(c) of this chapter. cats, and horses (not for food use). (1) See Nos. 050749, 054628, 054925, 058005, and 061623 for use on dogs, cats, [45 FR 43402, June 27, 1980, as amended at 47 or horses. FR 43368, Oct. 1, 1982; 48 FR 28984, June 24, (2) See No. 017135 for use on dogs and 1983; 53 FR 40728, Oct. 18, 1988; 54 FR 30542, horses. July 21, 1989; 56 FR 50653, Oct. 8, 1991; 59 FR 33197, June 28, 1994; 60 FR 55659, Nov. 2, 1995; (3) See Nos. 017153 and 058829 for use 62 FR 35077, June 30, 1997; 76 FR 17778, Mar. on horses. 31, 2011; 78 FR 21060, Apr. 9, 2013. Redesig- (c) [Reserved] nated at 79 FR 10971, Feb. 27, 2014] (d) Conditions of use—(1) Amount. Apply directly on the lesion with a § 524.1580c Nitrofurazone and buta- spatula or first place on a piece of caine ointment. gauze. The preparation should remain (a) Specifications. The drug contains on the lesion for at least 24 hours. Use 0.2 percent nitrofurazone and 0.5 per- of a bandage is optional. cent butacaine sulfate in a water-solu- (2) Indications for use. For prevention ble base. or treatment of surface bacterial infec- (b) Sponsor. See No. 054925 in tions of wounds, burns, and cutaneous § 510.600(c) of this chapter. ulcers of dogs, cats, or horses. (c) Conditions of use—(1) Indications (3) Limitations. For use only on dogs, cats, and horses. Do not use in horses for use. For prevention or treatment of intended for human consumption. Fed- surface bacterial infections of ears, eral law prohibits the use of this prod- wounds, burns, and cutaneous ulcers of uct in food-producing animals. In case dogs, cats, and horses. of deep or puncture wounds or serious (2) Limitations. Apply directly on the burns, use only as recommended by lesion with a spatula or first place on a veterinarian. If redness, irritation, or piece of gauze. Use of a bandage is op- swelling persists or increases, dis- tional. The preparation should remain continue use; consult veterinarian. on the lesion for at least 24 hours. The dressing may be changed several times [46 FR 43402, June 27, 1980. Redesignated at 79 FR 10971, Feb. 27, 2014] daily or left on the lesion for a longer period. For use only on dogs, cats, and EDITORIAL NOTE: For FEDERAL REGISTER ci- horses (not for food use). In case of tations affecting § 524.1580a, see the List of deep or puncture wounds or serious CFR Sections Affected, which appears in the Finding Aids section of the printed volume burns, use only as recommended by a and at www.fdsys.gov. veterinarian. If redness, irritation, or

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swelling persists or increases, dis- (3) Limitations. Federal law restricts continue use; consult veterinarian. this drug to use by or on the order of a licensed veterinarian. [49 FR 9417, Mar. 13, 1984, as amended at 71 FR 13542, Mar. 16, 2006. Redesignated at 79 FR [40 FR 13873, Mar. 27, 1975, as amended at 43 10971, Feb. 27, 2014] FR 29770, July 11, 1978; 50 FR 41490, Oct. 11, 1985; 53 FR 39257, Oct. 6, 1988; 54 FR 5431, Feb. § 524.1600 Nystatin ophthalmic and 3, 1989; 54 FR 48090, Nov. 21, 1989; 56 FR 50653, topical dosage forms. 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, § 524.1600a Nystatin, neomycin, 2003; 70 FR 50183, Aug. 26, 2005; 71 FR 13542, thiostrepton, and triamcinolone Mar. 16, 2006; 79 FR 10972, Feb. 27, 2014] ointment. (a) Specifications. Each milliliter of § 524.1600b Nystatin, neomycin, petrolatum base or each gram of van- thiostrepton, and triamcinolone ophthalmic ointment. ishing cream base ointment contains: 100,000 units of nystatin; neomycin sul- (a) Specifications. Each cubic centi- fate equivalent to 2.5 milligrams of ne- meter of ointment contains: 100,000 omycin base; 2,500 units of units of nystatin, neomycin sulfate equivalent to 2.5 milligrams of neomy- thiostrepton; and 1.0 milligram of cin base, 2,500 units of thiostrepton, triamcinolone acetonide. and 1.0 milligram of triamcinolone (b) Sponsors. For petrolatum base acetonide. ointments see Nos. 000856, 025463, 054771, (b) Sponsor. See No. 053501 in and 054925 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. For vanishing cream base ointments (c) Conditions of use—(1) Dogs and see Nos. 025463, 054771, and 054925. cats—(i) Amount. Apply 1 drop of oint- (c) Conditions of use—(1) Amount. (i) ment to the affected eye(s) 2 or 3 times For topical dermatological use: Clean daily. Treatment may be continued for affected areas and remove any en- up to 2 weeks if necessary. crusted discharge or exudate, and apply (ii) Indications for use. For use as an sparingly either ointment in a thin anti-inflammatory, antipruritic, film. antifungal (Candida albicans), and anti- (ii) For otic use: Clean ear canal of bacterial ointment for local therapy in impacted cerumen, remove any foreign keratitis and conjunctivitis. bodies such as grass awns and ticks, (iii) Limitations. Federal law restricts this drug to use by or on the order of a and instill three to five drops of petro- licensed veterinarian. latum base ointment. Preliminary use (2) Cattle—(i) Amount. Apply small of a local anesthetic may be advisable. line of ointment to the affected eye(s) (iii) For infected anal glands and cys- once daily. Treatment may be contin- tic areas: Drain gland or cyst and fill ued for up to 2 weeks if necessary. with petrolatum base ointment. (ii) Indications for use. For infectious (2) Indications for use. (i) Topically: kerato-conjunctivitis (pinkeye). Use either ointment in dogs and cats (iii) Limitations. Federal law restricts for anti-inflammatory, antipruritic, this drug to use by or on the order of a antifungal, and antibacterial treat- licensed veterinarian. ment of superficial bacterial infec- [40 FR 13873, Mar. 27, 1975, as amended at 50 tions, and for dermatologic disorders FR 41490, Oct. 11, 1985; 79 FR 10972, Feb. 27, characterized by inflammation and dry 2014] or exudative dermatitis, particularly associated with bacterial or candidal § 524.1610 Orbifloxacin, mometasone (Candida albicans) infections. furoate monohydrate, and posaconazole suspension. (ii) Otitis, cysts, and anal gland infections: Use petrolatum base ointment (a) Specifications. Each gram of suspension contains 10 milligrams (mg) in dogs and cats for the treatment of orbifloxacin, mometasone furoate acute and chronic otitis and interdig- monohydrate equivalent to 1 mg ital cysts, and in dogs for anal gland mometasone furoate, and 1 mg infections. posaconazole.

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

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

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42 days after the latest infusion. For (2) Indications for use. For the treat- use in dry cows only. ment of mastitis caused by Staphy- lococcus aureus and Streptococcus [43 FR 37174, Aug. 22, 1978, as amended at 53 FR 27851, July 25, 1988; 73 FR 12262, Mar. 7, agalactiae including penicillin resistant 2008; 75 FR 10168, Mar. 5, 2010; 76 FR 17338, strains in dairy cows during the dry pe- Mar. 29, 2011] riod. (3) Limitations. For use in dry cows § 526.365 Cephapirin sodium. only. Not to be used within 30 days of (a) Specifications. Each 10-milliliter calving. Animals infused with this dose contains 200 milligrams of product must not be slaughtered for cephapirin sodium activity in a peanut- food use for 30 days after the latest in- oil gel. fusion. Federal law restricts this drug (b) Sponsor. See No. 000010 in to use by or on the order of a licensed § 510.600(c) of this chapter. veterinarian. (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 § 526.464b Cloxacillin benzathine for after the quarter has been completely 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 the cow. [40 FR 57455, Dec. 10, 1975, as amended at 53 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 calving must not be used for human § 526.464 Cloxacillin intramammary food. Animals infused with this product dosage forms. must not be slaughtered for food from the time of infusion until 72 hours after § 526.464a Cloxacillin benzathine. calving. Federal law restricts this drug (a) Specifications. Each dose contains to use by or on the order of a licensed cloxacillin benzathine equivalent to 500 veterinarian. milligrams of cloxacillin. (d) Sponsor. See No. 000061 in (b) Related tolerances. See § 556.165 of § 510.600(c) of this chapter. this chapter. (1) Amount. One dose per infected (c) Sponsor. See No. 000010 in quarter immediately after last milk- § 510.600(c) of this chapter for use in ing. dairy cows. (2) Indications for use. Treatment and (1) Amount. Administer aseptically prophylaxis of bovine mastitis in non- into each quarter immediately after lactating cows due to Streptococcus last milking. agalactiae and Staphylococcus aureus.

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(3) Limitations. For use in dry cows and 0.90 milligram of butylated hy- only. Not to be used within 4 weeks (28 droxytoluene. days) of calving. Animals infused with (3) The vehicle is triglyceride of satu- this product must not be slaughtered rated fatty acids from coconut oil. for food use for 4 weeks (28 days) after (4) The drug may or may not be ster- the latest infusion. Federal law re- ile. stricts this drug to use by or on the (b) Sponsor. See Nos. 054771 and 061623 order of a licensed veterinarian. in § 510.600(c) of this chapter. (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, 1993; 60 FR 55660, Nov. 2, 1995; 68 FR 44878, ing, and disinfecting, infuse contents of July 31, 2003] a single 6-milliliter syringe into each infected quarter; repeat procedure at § 526.464c Cloxacillin sodium for 12-hour intervals for a maximum of 3 intramammary infusion, sterile. consecutive infusions. (a) Specifications. Each milliliter con- (ii) Dry cows: After milking, clean- tains cloxacillin sodium equivalent to ing, and disinfecting, infuse contents of 20.0 milligrams of cloxacillin. a single 12-milliliter syringe into each 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 strains. [47 FR 15772, Apr. 13, 1982, as amended at 66 (3) Limitations. Administer after FR 14074, Mar. 9, 2001; 68 FR 4915, Jan. 31, milking, cleaning, and disinfecting, 2003; 79 FR 10973, Feb. 27, 2014] and as early as possible after detection. § 526.1130 Hetacillin infusion. Treatment should be repeated at 12- hour intervals for a total of three (a) Specifications. Each 10 milliliter doses. Milk taken from treated animals syringe contains hetacillin potassium within 48 hours (four milkings) after equivalent of 62.5 milligrams of ampi- the latest treatment should not be used cillin. for food. Treated animals should not be (b) Sponsor. See No. 000010 in slaughtered for food within 10 days § 510.600(c) of this chapter. after the latest treatment. Federal law (c) Conditions of use. Lactating cows— restricts this drug to use by or on the (1) Amount. 10 milliliters of hetacillin order of a licensed veterinarian. potassium equivalent to 62.5 milligrams 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. butylated hydroxyanisole, and 0.45 mil- (3) Limitations. Milk that has been ligram of butylated hydroxytoluene. taken from animals during treatment (2) Each 12-milliliter, single-dose, dis- and for 72 hours (6 milkings) after the posable syringe contains 600 milligrams latest treatment must not be used for of erythromycin (as the base), 0.90 mil- food. Treated animals must not be ligram of butylated hydroxyanisole, slaughtered for food until 10 days after

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

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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- § 528.1070 Bc6 recombinant lowing udder infusion. deoxyribonucleic acid construct. [57 FR 37336, Aug. 18, 1992; 57 FR 42623, Sept. (a) Specifications and indications for 15, 1992; 79 FR 10973, Feb. 27, 2014] use. Five copies of a human Bc6 recombinant deoxyribonucleic acid (rDNA) § 526.1810 Pirlimycin. construct located at the GTC 155–92 (a) Specifications. Each 10-milliliter site in a specific hemizygous diploid syringe contains 50 milligrams (mg) line of dairy breeds of domestic goats (Capra aegagrus hircus) directing the pirlimycin (as pirlimycin hydro- expression of the human gene for chloride). antithrombin (which is intended for (b) Sponsor. See No. 054771 in the treatment of humans) in the mam- § 510.600(c) of this chapter. mary gland of goats derived from lin- (c) Related tolerances. See § 556.515 of eage progenitor 155–92. this chapter. (b) Sponsor. See No. 042976 in § 510.600 (d) Conditions of use in cattle—(1) of this chapter. Amount. Infuse 50 mg into each infected (c) Limitations. Food or feed from quarter. Repeat treatment after 24 GTC–155–92 goats is not permitted in hours. Daily treatment may be re- the food or feed supply. peated at 24-hour intervals for up to 8 consecutive days. PART 529—CERTAIN OTHER DOS- (2) Indications for use. For the treat- AGE FORM NEW ANIMAL ment of clinical and subclinical mas- DRUGS titis in lactating dairy cattle associated with Staphylococcus species such Sec. as Staphylococcus aureus and Strepto- 529.40 Albuterol. coccus species such as Streptococcus 529.56 Amikacin. agalactiae, Streptococcus dysgalactiae, 529.400 Chlorhexidine tablets and suspen- and Streptococcus uberis. sion. (3) Limitations. Milk taken from ani- 529.536 Detomidine. mals during treatment and for 36 hours 529.778 Doxycycline. following the last treatment must not 529.1030 Formalin. be used for food regardless of treat- 529.1044 Gentamicin in certain other dosage ment duration. Following infusion forms. 529.1044a Gentamicin solution for infusion. twice at a 24-hour interval, treated ani- 529.1044b Gentamicin solution for dipping mals must not be slaughtered for 9 eggs. days. Following any extended duration 529.1115 Halothane. of therapy (infusion longer than twice 529.1150 Hydrogen peroxide. at a 24-hour interval, up to 8 consecu- 529.1186 Isoflurane. tive days), animals must not be slaugh- 529.1350 Meloxicam. tered for 21 days. Federal law restricts 529.1660 Oxytetracycline. this drug to use by or on the order of a 529.1940 Progesterone intravaginal inserts. licensed veterinarian. 529.2150 Sevoflurane. 529.2464 Ticarcillin. [58 FR 58486, Nov. 2, 1993, as amended at 65 529.2503 Tricaine methanesulfonate. FR 61091, Oct. 16, 2000; 73 FR 811, Jan. 4, 2008; 529.2620 Triptorelin. 79 FR 10973, Feb. 27, 2014] AUTHORITY: 21 U.S.C. 360b.

SOURCE: 40 FR 13881, Mar. 27, 1975, unless PART 528—NEW ANIMAL DRUGS IN otherwise noted. GENETICALLY ENGINEERED ANI- MALS § 529.40 Albuterol. (a) Specifications. A net weight of 6.7 AUTHORITY: 21 U.S.C. 360b. grams of formulated albuterol sulfate is supplied in a pressurized aluminum SOURCE: 74 FR 6823, Feb. 11, 2009, unless canister within an actuator system otherwise noted. equipped with a detachable nasal delivery bulb.

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(b) Approvals. See No. 000010 in (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter for uses as in § 510.600(c) of this chapter. paragraph (d) of this section. (c) Conditions of use—(1) Amount. (c) Conditions of use—(1) Amount. Place 1 or 2 tablets deep in each uter- Each valve actuation (puff) of the de- ine horn; or infuse a solution of 1 tab- vice delivers 120 micrograms (mcg) of let disolved in an appropriate amount albuterol sulfate. One dose is three (3) of clean boiled water; or infuse one sy- puffs, totaling 360 mcg. ringe of suspension into the uterus. (2) Indications for use. For the imme- (2) Indications for use. For prevention diate relief of bronchospasm and or treatment of metritis and vaginitis bronchoconstriction associated with in cows and mares when caused by reversible airway obstruction in pathogens sensitive to chlorhexidine horses. dihydrochloride. (3) Not for use in horses intended for (3) Limitations. Prior to administra- food. Federal law restricts this drug to tion, remove any unattached placental use by or on the order of a licensed vet- membranes, any excess uterine fluid or erinarian. debris, and carefully clean external genitalia. Use a clean, sterile insemi- [67 FR 7072, Feb. 15, 2002, as amended at 79 nating pipette for administrating solu- FR 10973, Feb. 27 , 2014] tions and suspensions. Treatment may § 529.56 Amikacin. be repeated in 48 to 72 hours. (a) Specifications. Each milliliter [43 FR 10705, Feb. 23, 1979, as amended at 79 (mL) of solution contains 250 milli- FR 10973, Feb. 27, 2014] grams of amikacin as amikacin sulfate. EDITORIAL NOTE: At 79 FR 10973, Feb. 27, (b) Sponsors. See Nos. 000859 and 2014, § 529.400 was amended to revise the sec- 054771 in § 510.600(c) of this chapter. tion heading, however, the section heading (c) Conditions of use in horses—(1) was not provided, therefore, the amendment Amount. Administer 2 grams (8 mL) di- could not be incorporated due to inaccurate amendatory instruction. luted with 200 mL of sterile physiological saline by intrauterine infusion § 529.536 Detomidine. daily for 3 consecutive days. (a) Each milliliter of (2) Indications for use. For treating Specifications. genital tract infections (endometritis, gel contains 7.6 milligrams (mg) of metritis, and pyometra) in mares detomidine hydrochloride. caused by susceptible organisms in- (b) Sponsor. See No. 052483 in cluding Escherichia coli, Pseudomonas § 510.600(c) of this chapter. spp., and Klebsiella spp. (c) Conditions of use in horses—(1) Administer 0.018 mg per pound (3) Limitations. Do not use in horses Amount. intended for human consumption. Fed- (mg/lb) (0.040 mg/kilogram (kg) sublin- eral law restricts this drug to use by or gually. on the order of a licensed veterinarian. (2) Indications for use. For sedation and restraint. [76 FR 17339, Mar. 29, 2011, as amended at 78 (3) Limitations. Federal law restricts FR 17597, Mar. 22, 2013; 79 FR 10973, Feb. 27, this drug to use by or on the order of a 2014] licensed veterinarian. Do not use in horses intended for human consump- § 529.400 Chlorhexidine tablets and suspension. tion. (a) Specification. Each tablet and each [75 FR 21163, Apr. 23, 2010, as amended at 76 28-milliliter syringe of suspension con- FR 16533, Mar. 24, 2011] tain 1 gram of chlorhexidine § 529.778 Doxycycline. dihydrochloride.1 (a) Specifications. Doxycycline hyclate solution contains 8.5 percent 1 These conditions are NAS/NRC reviewed doxycycline activity. A syringe of N- and deemed effective. Applications for these uses need not include effectiveness data as methyl-2-pyrrolidone and poly (DL- specified by § 514.111 of this chapter, but may lactide) mixed with a syringe of require bioequivalency and safety informa- doxycycline produces 0.5 milliliter of tion. solution.

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(b) Sponsor. See 054771 in § 510.600(c) of Administer in tanks this chapter. and raceways for Administer in up to 1 hour earthen ponds in- (c) Conditions of use in dogs—(1) Aquatic species (microliter/liter or definitely (μL/L or Amount. Apply subgingivally to peri- part per million ppm) (μL/L or ppm)) odontal pocket(s) of affected teeth. (2) Indications for use. For treatment Below 50 °F Up to 250 15 to 25 12 and control of periodontal disease. All other finfish Up to 250 15 to 25 12 (3) Limitations. Federal law restricts 1 Use the lower concentration when ponds, tanks, or raceways are heavily loaded with phytoplankton or fish to avoid this drug to use by or on the order of a oxygen depletion due to the biological oxygen demand by licensed veterinarian. decay of dead phytoplankton. Alternatively, a higher concentration may be used if dissolved oxygen is strictly mon- [79 FR 10973, Feb. 27, 2014] itored. 2 Although the indicated concentrations are considered safe for cold and warm water finfish, a small number of each lot or § 529.1030 Formalin. pond to be treated should always be used to check for any (a) Specifications. Formalin is an unusual sensitivity to formalin before proceeding. aqueous solution containing approxi- (iii) For control of fungi of the fam- mately 37 percent by weight of form- ily Saprolegniaceae on finfish eggs: aldehyde gas, U.S.P. Eggs of all finfish except (b) Sponsors. See Nos. 049968, 050378, Acipenseriformes, 1,000 to 2,000 μL/L and 067188 in § 510.600(c) of this chapter. (ppm) for 15 minutes; eggs of (c) [Reserved] Acipenseriformes, up to 1,500 μL/L (d) Conditions of use. It is added to en- (ppm) for 15 minutes. vironmental water as follows: (3) Limitations. Fish tanks and race- (1) Indications for use. (i) Penaeid ways may be treated daily until para- shrimp. For control of external proto- site control is achieved. Pond treat- zoan parasites Bodo spp., Epistylis spp., ment may be repeated in 5 to 10 days if and Zoothamnium spp. needed. However, pond treatments for (ii) All finfish. For control of exter- Ichthyophthirius should be made at 2- nal protozoa Ichthyophthirius spp., day intervals until control is achieved. Chilodonella spp., Ichthyobodo spp., Egg tanks may be treated as often as Ambiphrya spp., Epistylis spp., and necessary to prevent growth of fungi. Trichodina spp., and monogenetic Do not use formalin which has been trematodes Cleidodiscus spp., subjected to temperatures below 40 °F, Gyrodactylus spp., and Dactylogyrus spp. or allowed to freeze. Do not treat ponds (iii) All finfish eggs: For control of containing striped bass. Treatments in fungi of the family Saprolegniaceae. tanks should never exceed 1 hour even (2) Amount. The drug concentrations if fish show no signs of stress. Do not required are as follows: apply formalin to ponds with water (i) For control of external protozoan warmer than 27 °C (80 °F), when a parasites on shrimp: heavy bloom of phytoplankton is present, or when the concentration of Concentration of formalin (microliters per liter) dissolved oxygen is less than 5 milli- Shrimp grams per liter. Tanks and race- Earthen ponds ways (up to 4 [51 FR 11441, Apr. 3, 1986, as amended at 58 hours daily) (single treatment) FR 59169, Nov. 8, 1993; 59 FR 60076, Nov. 22, Penaeid Shrimp ... 50 to 100 1 ...... 25 2 1994; 63 FR 38304, July 16, 1998; 68 FR 5563; Feb. 4, 2003; 72 FR 45158, Aug. 13, 2007; 76 FR 1 Treat for up to 4 hours daily. Treatment may be repeated daily until parasite control is achieved. Use the lower con- 17339, Mar. 29, 2011; 79 FR 2786, Jan. 16, 2014] centration when the tanks and raceways are heavily loaded. 2 Single treatment. Treatment may be repeated in 5 to 10 days if needed. § 529.1044 Gentamicin in certain other dosage forms. (ii) For control of external parasites on finfish: § 529.1044a Gentamicin solution for infusion. Administer in tanks and raceways for Administer in (a) Specifications. Each milliliter of up to 1 hour earthen ponds in- solution contains 50 or 100 milligrams Aquatic species (microliter/liter or definitely (μL/L or part per million ppm) gentamicin sulfate. (μL/L or ppm)) (b) Sponsors. See Nos. 000061, 000859, Salmon and trout: 054628, 054771, 057561, 058005, and 061623 Above 50 °F Up to 170 15 to 25 12 in § 510.600(c) of this chapter.

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(c) Conditions of use in horses—(1) § 529.1115 Halothane. Amount. Infuse 2 to 2.5 grams per day (a) Specifications. The drug is a color- for 3 to 5 days during estrus. less, odorless, nonflammable, nonexplo- (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. [46 FR 27915, May 22, 1981, as amended at 62 (a) Specifications. Each milliliter of FR 29014, May 29, 1997; 79 FR 10973, Feb. 27, solution contains gentamicin sulfate 2014] equivalent to 50 milligrams of gentamicin base. § 529.1150 Hydrogen peroxide. (b) Sponsors. See Nos. 000061 and (a) Specifications. Each milliliter of 054925 in § 510.600(c) of this chapter. solution contains 396.1 milligrams (mg) (c) Conditions of use in turkeys—(1) hydrogen peroxide (a 35% w/w solu- Amount. The drug is added to clean tion). water to provide a dip solution with a (b) Sponsor. See No. 050378 in gentamicin concentration of 250 to § 510.600(c) of this chapter. 1,000 parts per million. A concentration (c) Conditions of use in finfish—(1) of 500 parts per million is rec- Amount—(i) Freshwater-reared finfish ommended. Clean eggs should be held eggs: 500 to 1,000 mg per liter (/L) of submerged in the gentamicin solution culture water for 15 minutes in a con- under a vacuum of about 27.5 to 38 cen- tinuous flow system once per day on timeters of mercury for 5 minutes fol- consecutive or alternate days until lowed by additional soaking in hatch for all coldwater and coolwater gentamicin solution for approximately species of freshwater-reared finfish 10 minutes at atmospheric pressure. eggs or 750 to 1,000 mg/L for 15 minutes Eggs can also be treated by warming in a continuous flow system once per them for 3 to 6 hours at approximately day on consecutive or alternate days 100 °F then immediately submerging until hatch for all warmwater species them in gentamicin solution main- of freshwater-reared finfish eggs. tained at about 40 °F, keeping the eggs (ii) Freshwater-reared salmonids: 100 submerged for 10 to 15 minutes. mg/L for 30 minutes or 50 to 100 mg/L (2) Indications for use. As an aid in the for 60 minutes once per day on alter- reduction or elimination of the fol- nate days for three treatments in a lowing microorganisms from turkey- continuous flow water supply or as a hatching eggs: Arizona hinshawii static bath. (paracolon), Salmonella Saintpaul, and (iii) Coolwater species of freshwater- Mycoplasma meleagridis. reared finfish fingerlings and adults (3) Limitations. For use in the dipping (except northern pike & paddlefish) and treatment of turkey-hatching eggs channel catfish fingerlings and adults: only. Eggs which have been dipped in 50 to 75 mg/L for 60 minutes once per the drug shall not be used for food. day on alternate days for three treat- [40 FR 13881, Mar. 27, 1975, as amended at 52 ments in continuous flow water supply FR 7833, Mar. 13, 1987; 62 FR 22889, Apr. 28, or as a static bath. Coolwater species 1997; 71 FR 13543, Mar. 16, 2006; 79 FR 10973, of freshwater-reared finfish fry (except Feb. 27, 2014] northern pike, pallid sturgeon &

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paddlefish) and channel catfish fry: 50 eral law restricts this drug to use by or mg/L for 60 minutes once per day on al- on the order of a licensed veterinarian. ternate days for three treatments in [51 FR 594, Jan. 7, 1986, as amended at 54 FR continuous flow water supply or as a 23472, June 1, 1989; 58 FR 17346, Apr. 2, 1993; 59 static bath. FR 44315, Aug. 29, 1994; 60 FR 40456, Aug. 9, (2) Indications for use. For control of 1995; 63 FR 8122, Feb. 18, 1998; 63 FR 24106, mortality in freshwater-reared finfish May 1, 1998; 66 FR 17510, Apr. 2, 2001; 71 FR eggs due to saprolegniasis; for control 43967, Aug. 3, 2006; 74 FR 68530, Dec. 28, 2009; of mortality in freshwater-reared 76 FR 16533, Mar. 24, 2011; 78 FR 14669, Mar. 7, salmonids due to bacterial gill disease 2013; 78 FR 17868, Mar. 25, 2013] associated with Flavobacterium § 529.1350 Meloxicam. branchiophilum; and for control of mortality in freshwater-reared coolwater (a) Specifications. Each milliliter of finfish and channel catfish due to ex- solution contains 5 milligrams (mg) ternal columnaris disease associated meloxicam. with Flavobacterium columnare (b) Sponsor. See No. 000074 in (Flexibacter columnaris). § 510.600(c) of this chapter. (3) Limitations. Initial bioassay on a (c) Conditions of use in dogs—(1) small number is recommended before Amount. Administer 0.1 mg per kilo- treating the entire group. Eggs: Some gram of body weight once daily using strains of rainbow trout eggs are sen- the metered dose pump. sitive to hydrogen peroxide treatment (2) Indications for use. For the control at a time during incubation concurrent of pain and inflammation associated with blastopore formation through clo- with osteoarthritis in dogs. sure, about 70 to 140 Daily Temperature (3) Limitations. Federal law restricts Units, °C. Consider withholding treat- this drug to use by or on the order of a ment or using an alternate licensed veterinarian. therapeutant during that sensitive [77 FR 76863, Dec. 31, 2012] time to reduce egg mortalities due to drug toxicity. Finfish: Use with cau- § 529.1660 Oxytetracycline. tion on walleye. Preharvest withdrawal (a) Specifications—(1) Each gram of time: zero days. powder contains 366 milligrams (mg) [72 FR 5330, Feb. 6, 2007, as amended at 78 FR oxytetracycline hydrochloride. 73698, Dec. 9, 2013] (2) Each gram of powder contains 753 mg oxytetracycline hydrochloride. § 529.1186 Isoflurane. (b) Sponsors. See sponsors in (a) Specifications. The drug is a clear, § 510.600(c) of this chapter for use of colorless, stable liquid. products described in paragraph (a) of (b) Sponsors. See Nos. 000044, 010019, this section as in paragraph (d) of this 012164, 065085, and 066794 in § 510.600(c) of section. this chapter. (1) Nos. 054771 and 061623 for use of (c) Conditions of use. Administer by product in paragraph (a)(1) of this sec- inhalation: tion. (1) Amount—(i) Horses: For induction (2) Nos. 048164, 054771, and 061623 for of surgical anesthesia: 3 to 5 percent use of product described in paragraph isoflurane (with oxygen) for 5 to 10 (a)(2) of this section. minutes. For maintenance of surgical (c) Related tolerances. See § 556.500 of anesthesia: 1.5 to 1.8 percent isoflurane this chapter. (with oxygen). (d) Conditions of use in finfish—(1) (ii) Dogs: For induction of surgical Amount. Immerse fish in a solution anesthesia: 2 to 2.5 percent isoflurane containing 200 to 700 mg oxytetra- (with oxygen) for 5 to 10 minutes. For cycline hydrochloride (buffered) per maintenance of surgical anesthesia: 1.5 liter of water for 2 to 6 hours. to 1.8 percent isoflurane (with oxygen). (2) Indications for use. For skeletal (2) Indications for use. For induction marking of finfish fry and fingerlings. and maintenance of general anesthesia [69 FR 6557, Feb. 11, 2004, as amended at 69 in horses and dogs. FR 61999, Oct. 22, 2004; 70 FR 41140, July 18, (3) Limitations. Do not use in horses 2005; 72 FR 26289, May 9, 2007; 76 FR 17026, intended for human consumption. Fed- Mar. 28, 2011; 79 FR 10973, Feb. 27, 2014]

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§ 529.1940 Progesterone intravaginal seminated at the immediately pre- inserts. ceding estrus. (a) Specifications. Each insert con- (D) For induction of estrous cycles in tains: anestrous lactating dairy cows. (1) 1.38 grams (g) progesterone in (iii) Limitations. Do not use in beef or molded silicone over a nylon spine. dairy heifers of insufficient size or age (2) 0.3 g progesterone in molded sili- for breeding or in animals with abnor- cone over a flexible nylon spine. mal, immature, or infected genital (b) Sponsor. See No. 054771 in tracts. Do not use in beef cows that are § 510.600(c) of this chapter for use of the fewer than 20 days postpartum. Do not product described in paragraph (a)(1) of use an insert more than once. To pre- this section as in paragraph (e)(1) of vent the potential transmission of ve- this section; and the product described nereal and bloodborne diseases, the in- in paragraph (a)(2) of this section as in serts should be disposed after a single paragraph (e)(2) of this section. use. Administration of vaginal inserts (c) Related tolerances. See § 556.540 of for periods greater than 7 days may re- this chapter. sult in reduced fertility. Dinoprost so- (d) Special considerations—(1) Cows lution provided by No. 054771 in and ewes. Product labeling shall bear § 510.600(c) of this chapter. the following warnings: ‘‘Avoid contact (2) Ewes—(i) Amount. Administer one with skin by wearing protective gloves intravaginal insert per animal for 5 when handling inserts. Store removed days. inserts in a sealable container until (ii) Indications for use. For induction they can be disposed of in accordance of estrus in ewes (sheep) during sea- with applicable local, state, and Fed- sonal anestrus. eral regulations.’’ (iii) Limitations. Do not use in ani- (2) Cows. This product is approved mals with abnormal, immature, or in- with the concurrent use of dinoprost fected genital tracts; or in ewes that solution when used for indications list- have never lambed. Do not use an in- ed in paragraphs (e)(1)(ii)(A) and sert more than once. To prevent the (e)(1)(ii)(B) of this section. See potential transmission of venereal and § 522.690(c) of this chapter. bloodborne diseases, the inserts should (e) Conditions of use—(1) Cows—(i) be disposed after a single use. Amount. Administer one intravaginal insert per animal for 7 days. When used [74 FR 59074, Nov. 17, 2009, as amended at 75 for indications listed in paragraph FR 63085, Oct. 14, 2010; 79 FR 10965, 10974, Feb. 27, 2014] (e)(1)(ii)(A) of this section, administer 25 milligrams (mg) dinoprost (5 milli- § 529.2150 Sevoflurane. liters (mL) of 5 mg/mL solution as in § 522.690(a) of this chapter) as a single (a) Specifications. Sevoflurane liquid. intramuscular injection 1 day prior to (b) Sponsors. See Nos. 000044, 012164, insert removal (Day 6). When used for and 066794 in § 510.600(c) of this chapter. indications listed in paragraph (c) Conditions of use—(1) Amount. For (e)(1)(ii)(B) of this section, administer induction of surgical anesthesia: up to 25 mg dinoprost as a single 7 percent sevoflurane. For maintenance intramuscular injection on the day of of surgical anesthesia: 3.7 to 4 percent insert removal (Day 7). sevoflurane with oxygen in the absence (ii) Indications for use—(A) For syn- of premedication and 3.3 to 3.6 percent chronization of estrus in suckled beef in the presence of premedication. cows and replacement beef and dairy (2) Indications for use. For induction heifers; for advancement of first and maintenance of general anesthesia postpartum estrus in suckled beef in dogs. cows; and for advancement of first pu- (3) Limitations. Federal law restricts bertal estrus in replacement beef heif- this drug to use by or on the order of a ers. licensed veterinarian. (B) For synchronization of estrus in [64 FR 71640, Dec. 22, 1999, as amended at 73 lactating dairy cows. FR 25508, May 7, 2008; 74 FR 10484, Mar. 11, (C) For synchronization of the return 2009, 75 FR 1021, Jan. 8, 2010; 76 FR 16533, Mar. to estrus in lactating dairy cows in- 24, 2011; 78 FR 17868, Mar. 25, 2013]‘

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§ 529.2464 Ticarcillin. stricted to Ictaluridae, Salmonidae, Esocidae, and Percidae, and water tem- (a) Specifications. Each vial contains ° ° ticarcillin disodium powder equivalent perature exceeding 10 C (50 F). In 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) (a) Specifications. Each milliliter of Amount. Administer 6 grams daily by gel contains 100 micrograms (mcg) intrauterine infusion for 3 consecutive triptorelin as triptorelin acetate. days during estrus. (b) Sponsor. See No. 051233 in (2) Indications for use. For the treat- § 510.600(c) of this chapter. ment of endometritis caused by beta- (c) Conditions of use in swine—(1) hemolytic streptococci. Amount. Administer 200 mcg (3) Limitations. Do not use in horses intravaginally approximately 96 hours intended for human consumption. Fed- after weaning. eral law restricts this drug to use by or (2) Indications for use. For the syn- on the order of a licensed veterinarian. chronization of time of insemination in [79 FR 10974, Feb. 27, 2014] weaned sows to facilitate a single fixed-time artificial insemination. § 529.2503 Tricaine methanesulfonate. (3) Limitations. Not approved for use (a) Specifications. The drug is ethyl-m- in gilts. Safety and effectiveness have amino-benzoate methanesulfonate. not been evaluated in these animals. (b) Sponsor. See Nos. 050378 and 051212 Should not be used in sows with obvi- in § 510.600(c) of this chapter. ous reproductive tract abnormalities. (c) Conditions of use—(1) Amount. It is [77 FR 64717, Oct. 23, 2012] used as follows: (i) Fish. The drug is added to ambient PART 530—EXTRALABEL DRUG USE water at a concentration of from 15 to IN ANIMALS 330 milligrams per liter depending upon the degree of anesthetization or seda- Subpart A—General Provisions tion desired, the species and size of the fish, and the temperature and softness Sec. of the water. Preliminary tests of solu- 530.1 Scope. tions must be made with small num- 530.2 Purpose. bers of fish to determine the desired 530.3 Definitions. rates of sedation or anesthesia and the 530.4 Advertising and promotion. 530.5 Veterinary records. appropriate exposure times for the specific lots of fish under prevailing condi- Subpart B—Rules and Provisions for tions. Extralabel Uses of Drugs in Animals (ii) Amphibians and other aquatic coldblooded animals. The drug is added to 530.10 Provision permitting extralabel use ambient water in concentrations of of animal drugs. from 1:1000 to 1:20,000 depending upon 530.11 Limitations. 530.12 Labeling. species and stage of development. 530.13 Extralabel use from compounding of (2) Indications for use. For the tem- approved new animal and approved porary immobilization of fish, amphib- human drugs. ians, and other aquatic coldblooded animals (poikilotherms) as an aid in Subpart C—Specific Provisions Relating to handling during manual spawning (fish Extralabel Use of Animal and Human stripping), weighing, measuring, mark- Drugs in Food-Producing Animals ing, surgical operations, transport, 530.20 Conditions for permitted extralabel photography, and research. animal and human drug use in food-pro- (3) Limitations. Do not use within 21 ducing animals. days of harvesting fish for food. Use in 530.21 Prohibitions for food-producing ani- fish intended for food should be re- mals.

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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 cies not listed in the labeling, use for safe levels. 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 in the labeling, and deviation from the Subpart D—Extralabel Use of Human and labeled withdrawal time based on these Animal Drugs in Animals Not Intended different uses. for Human Consumption (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 that a drug’s use may present a risk to the Subpart E—Safe Levels for Extralabel Use of public health means that FDA has rea- Drugs in Animals and Drugs Prohibited son to believe that use of a drug may From Extralabel Use in Animals be likely to cause a potential adverse event. 530.40 Safe levels and availability of analyt- (d) The phrase use of a drug may ical methods. 530.41 Drugs prohibited for extralabel use in present a risk to the public health means animals. that FDA has information that indicates that use of a drug may cause an AUTHORITY: 15 U.S.C. 1453, 1454, 1455; 21 adverse event. U.S.C. 321, 331, 351, 352, 353, 355, 357, 360b, 371, 379e. (e) The phrase use of a drug presents a risk to the public health means that FDA SOURCE: 61 FR 57743, Nov. 7, 1996, unless has evidence that demonstrates that otherwise noted. the use of a drug has caused or likely will cause an adverse event. Subpart A—General Provisions (f) A residue means any compound present in edible tissues that results § 530.1 Scope. from the use of a drug, and includes the This part applies to the extralabel drug, its metabolites, and any other use in an animal of any approved new substance formed in or on food because animal drug or approved new human of the drug’s use. drug by or on the lawful order of a li- (g) A safe level is a conservative esti- censed veterinarian within the context mate of a drug residue level in edible of a valid veterinary-client-patient re- animal tissue derived from food safety lationship. data or other scientific information. Concentrations of residues in tissue § 530.2 Purpose. below the safe level will not raise The purpose of this part is to estab- human food safety concerns. A safe lish conditions for extralabel use or in- level is not a safe concentration or a tended extralabel use in animals by or tolerance and does not indicate that an on the lawful order of licensed veteri- approval exists for the drug in that narians of Food and Drug Administra- species or category of animal from tion approved new animal drugs and which the food is derived. approved new human drugs. Such use is (h) Veterinarian means a person li- limited to treatment modalities when censed by a State or Territory to prac- the health of an animal is threatened tice veterinary medicine. or suffering or death may result from (i) A valid veterinarian-client-patient failure to treat. This section imple- relationship is one in which: ments the Animal Medicinal Drug Use (1) A veterinarian has assumed the Clarification Act of 1994 (the AMDUCA) responsibility for making medical (Pub. L. 103–396). judgments regarding the health of (an) animal(s) and the need for medical § 530.3 Definitions. treatment, and the client (the owner of (a) Extralabel use means actual use or the animal or animals or other care- intended use of a drug in an animal in taker) has agreed to follow the instruc- a manner that is not in accordance tions of the veterinarian;

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(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); lated from more than one ingredient, (b) Extralabel use of an approved new the established name of each ingre- animal drug or human drug in or on an dient; animal feed; (2) The condition treated; (c) Extralabel use resulting in any (3) The species of the treated ani- residue which may present a risk to mal(s); the public health; and (4) The dosage administered; (d) Extralabel use resulting in any (5) The duration of treatment; residue above an established safe level, (6) The numbers of animals treated; safe concentration or tolerance. and (7) The specified withdrawal, with- § 530.12 Labeling. holding, or discard time(s), if applica- Any human or animal drug pre- ble, for meat, milk, eggs, or any food scribed and dispensed for extralabel use

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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) Any directions for use specified by (c) Guidance on the subject of the veterinarian, including the class/ compounding may be found in guidance species or identification of the animal documents issued by FDA. 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 for meat, milk, eggs, or any other food use in food-producing animals. 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 compounding of approved new ani- new animal and human drugs: mal and approved human drugs. (1) There is no approved new animal (a) This part applies to compounding drug that is labeled for such use and of a product from approved animal or that contains the same active ingre- human drugs by a veterinarian or a dient which is in the required dosage pharmacist on the order of a veteri- form and concentration, except where a narian within the practice of veteri- veterinarian finds, within the context nary medicine. Nothing in this part of a valid veterinarian-client-patient shall be construed as permitting relationship, that the approved new compounding from bulk drugs. animal drug is clinically ineffective for (b) Extralabel use from compounding its intended use. of approved new animal or human (2) Prior to prescribing or dispensing drugs is permitted if: an approved new animal or human drug (1) All relevant portions of this part for an extralabel use in food animals, have been complied with; the veterinarian must: (2) There is no approved new animal (i) Make a careful diagnosis and eval- or approved new human drug that, uation of the conditions for which the when used as labeled or in conformity drug is to be used; with criteria established in this part, (ii) Establish a substantially ex- will, in the available dosage form and tended withdrawal period prior to mar- concentration, appropriately treat the keting of milk, meat, eggs, or other ed- condition diagnosed. Compounding ible products supported by appropriate from a human drug for use in food-pro- scientific information, if applicable;

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(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: (b) FDA may require the develop- (1) Such use must be accomplished in ment of an acceptable analytical meth- accordance with an appropriate med- od for the quantification of residues ical rationale; and above any safe level established under (2) If scientific information on the this part. If FDA requires the develop- human food safety aspect of the use of ment of such an acceptable analytical the drug in food-producing animals is method, the agency will publish notice not available, the veterinarian must of that requirement in the FEDERAL take appropriate measures to assure REGISTER. that the animal and its food products (c) The extralabel use of an animal will not enter the human food supply. drug or human drug that results in res- (c) Extralabel use of an approved idues exceeding a safe level established human drug in a food-producing animal under this part is an unsafe use of such is not permitted under this part if an drug. animal drug approved for use in food- (d) If the agency establishes a safe producing animals can be used in an level for a particular species or cat- extralabel manner for the particular egory of animals and a tolerance or use. safe concentration is later established through an approval for that particular § 530.21 Prohibitions for food-pro- species or category of animals, for that ducing animals. species or category of animals, the safe (a) FDA may prohibit the extralabel level is superseded by the tolerance or use of an approved new animal or safe concentration for that species or human drug or class of drugs in food- category of animals. producing animals if FDA determines that: § 530.23 Procedure for setting and an- (1) An acceptable analytical method nouncing safe levels. needs to be established and such meth- (a) FDA may issue an order estab- od has not been established or cannot lishing a safe level for a residue of an be established; or extralabel use of an approved human (2) The extralabel use of the drug or drug or an approved animal drug. The class of drugs presents a risk to the agency will publish in the FEDERAL public health. REGISTER a notice of the order. The no- (b) A prohibition may be a general tice will include: ban on the extralabel use of the drug or (1) A statement setting forth the class of drugs or may be limited to a agency’s finding that there is a reason- specific species, indication, dosage able probability that extralabel use in form, route of administration, or com- animals of the human drug or animal bination of factors. drug may present a risk to the public health; § 530.22 Safe levels and analytical (2) A statement of the basis for that methods for food-producing ani- finding; and mals. (3) A request for public comments. (a) FDA may establish a safe level for (b) A current listing of those drugs extralabel use of an approved human for which a safe level for extralabel

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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 ducing animals if the agency finds, of prohibition, the agency will specify after providing an opportunity for pub- in the modified order of prohibition the lic comment, that: nature and extent of the modified pro- (1) An acceptable analytical method hibition, the reasons for it, and the required under § 530.22 has not been de- agency’s response to any comments on veloped, submitted, and found to be ac- the original order of prohibition. ceptable by FDA or that such method (f) A current listing of drugs prohib- cannot be established; or ited for extralabel use in animals will (2) The extralabel use in animals pre- be codified in § 530.41. sents a risk to the public health. (g) After the submission of appro- (b) After making a determination priate information (i.e., adequate data, that the analytical method required an acceptable method, approval of a under § 530.22 has not been developed new animal drug application for the

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prohibited extralabel use, or informa- § 530.41 Drugs prohibited for tion demonstrating that the prohibi- extralabel use in animals. tion was based on incorrect data), FDA (a) The following drugs, families of may, by publication of an appropriate drugs, and substances are prohibited notice in the FEDERAL REGISTER, re- for extralabel animal and human drug move a drug from the list of human uses in food-producing animals. and animal drugs prohibited for (1) Chloramphenicol; extralabel use in animals, or may mod- (2) Clenbuterol; ify a prohibition. (3) Diethylstilbestrol (DES); (h) FDA may prohibit extralabel use (4) Dimetridazole; of a drug in food-producing animals (5) Ipronidazole; without establishing a safe level. (6) Other nitroimidazoles; (7) Furazolidone. (8) Nitrofurazone. Subpart D—Extralabel Use of (9) Sulfonamide drugs in lactating Human and Animal Drugs in dairy cattle (except approved use of Animals Not Intended for sulfadimethoxine, Human Consumption sulfabromomethazine, and sulfaethoxypyridazine); § 530.30 Extralabel drug use in (10) Fluoroquinolones; and nonfood animals. (11) Glycopeptides. (a) Because extralabel use of animal (12) Phenylbutazone in female dairy and human drugs in nonfood-producing cattle 20 months of age or older. (13) Cephalosporins (not including animals does not ordinarily pose a cephapirin) in cattle, swine, chickens, threat to the public health, extralabel or turkeys: use of animal and human drugs is per- (i) For disease prevention purposes; mitted in nonfood-producing animal (ii) At unapproved doses, frequencies, practice except when the public health durations, or routes of administration; is threatened. In addition, the provi- or sions of § 530.20(a)(1) will apply to the (iii) If the drug is not approved for use of an approved animal drug. that species and production class. (b) If FDA determines that an (b) The following drugs, families of extralabel drug use in animals not in- drugs, and substances are prohibited tended for human consumption pre- for extralabel animal and human drug sents a risk to the public health, the uses in nonfood-producing animals: agency may publish in the FEDERAL [Reserved] REGISTER a notice prohibiting such use (c) [Reserved] following the procedures in § 530.25. The (d) The following drugs, or classes of prohibited extralabel drug use will be drugs, that are approved for treating or codified in § 530.41. preventing influenza A, are prohibited from extralabel use in chickens, turkeys, and ducks: Subpart E—Safe Levels for (1) Adamantanes. Extralabel Use of Drugs in Ani- (2) Neuraminidase inhibitors. mals and Drugs Prohibited [62 FR 27947, May 22, 1997, as amended at 67 From Extralabel Use in Ani- FR 5471, Feb. 6, 2002; 68 FR 9530, Feb. 28, 2003; mals 68 FR 14134, Mar. 24, 2003; 71 FR 14377, Mar. 22, 2006; 77 FR 745, Jan. 6, 2012] § 530.40 Safe levels and availability of analytical methods. PART 556—TOLERANCES FOR RESI- (a) In accordance with § 530.22, the DUES OF NEW ANIMAL DRUGS IN following safe levels for extralabel use FOOD of an approved animal drug or human drug have been established: [Reserved] Subpart A—General Provisions (b) In accordance with § 530.22, the Sec. following analytical methods have 556.1 General considerations; tolerances for been accepted by FDA: [Reserved] residues of new animal drugs in food.

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Subpart B—Specific Tolerances for 556.540 Progesterone. Residues of New Animal Drugs 556.560 Pyrantel tartrate. 556.570 Ractopamine. 556.34 Albendazole. 556.580 Robenidine hydrochloride. 556.36 Altrenogest. 556.592 Salinomycin. 556.38 Amoxicillin. 556.597 Semduramicin. 556.40 Ampicillin. 556.600 Spectinomycin. 556.50 Amprolium. 556.610 Streptomycin. 556.52 Apramycin. 556.620 Sulfabromomethazine sodium. 556.60 Arsenic. 556.625 Sodium sulfachloropyrazine 556.70 Bacitracin. monohydrate. 556.100 Carbadox. 556.630 Sulfachlorpyridazine. 556.110 Carbomycin. 556.640 Sulfadimethoxine. 556.113 Ceftiofur. 556.650 Sulfaethoxypyridazine. 556.115 Cephapirin. 556.660 Sulfamerazine. 556.120 Chlorhexidine. 556.670 Sulfamethazine. 556.150 Chlortetracycline. 556.685 Sulfaquinoxaline. 556.160 Clopidol. 556.690 Sulfathiazole. 556.163 Clorsulon. 556.700 Sulfomyxin. 556.165 Cloxacillin. 556.710 Testosterone propionate. 556.167 Colistimethate. 556.720 Tetracycline. 556.169 Danofloxacin. 556.730 Thiabendazole. 556.170 Decoquinate. 556.733 Tildipirosin. 556.180 Dichlorvos. 556.735 Tilmicosin. 556.185 Diclazuril. 556.738 Tiamulin. 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 556.360 Lincomycin. edible products of food-producing ani- 556.375 Maduramicin ammonium. mals treated with such drugs. Consid- 556.380 Melengestrol acetate. eration of an appropriate tolerance for 556.410 Metoserpate hydrochloride. a drug shall result in a conclusion ei- 556.420 Monensin. ther that: 556.425 Morantel tartrate. 556.426 Moxidectin. (1) Finite residues will be present in 556.428 Narasin. the edible products—in which case a fi- 556.430 Neomycin. nite tolerance is required; or 556.440 Nequinate. (2) It is not possible to determine 556.445 Nicarbazin. whether finite residues will be incurred 556.460 Novobiocin. but there is reasonable expectation 556.470 Nystatin. that they may be present—in which 556.480 Oleandomycin. case a tolerance for negligible residue 556.490 Ormetoprim. is required; or 556.495 Oxfendazole. 556.500 Oxytetracycline. (3) The drug induces cancer when in- 556.510 Penicillin. gested by man or animal or, after tests 556.513 Piperazine. which are appropriate for the evalua- 556.515 Pirlimycin. tion of the safety of such drug, has

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been shown to induce cancer in man or (2) Sheep—(i) Liver (target tissue): 0.25 animal; however, such drug will not ad- ppm. versely affect the animals for which it (ii) Muscle: 0.05 ppm. is intended, and no residue of such drug (3) Goat—(i) Liver (target tissue): 0.25 will be found by prescribed methods of ppm. analysis in any edible portion of such (ii) [Reserved] animals after slaughter or in any food (c) Related conditions of use. See yielded by or derived from the living § 520.45 of this chapter. animal—in which case the accepted [64 FR 1504, Jan. 11, 1999, as amended at 73 method of analysis shall be published FR 11027, Feb. 29, 2008] or cited, if previously published and available elsewhere, in this part; or § 556.36 Altrenogest. (4) It may or may not be possible to (a) Acceptable Daily Intake (ADI). The determine whether finite residues will ADI for total residues of altrenogest is be incurred but there is no reasonable 0.04 micrograms per kilogram of body expectation that they may be present— weight per day. in which case the establishment of a (b) Tolerances—(1) Swine—(i) Liver (the tolerance is not required; or target tissue). The tolerance for (5) The drug is such that it may be altrenogest (the marker residue) is 4 metabolized and/or assimilated in such parts per billion (ppb). form that any possible residue would (ii) Muscle. The tolerance for be indistinguishable from normal tis- altrenogest (the marker residue) is 1 sue constituents—in which case the es- ppb. tablishment of a tolerance is not re- (2) [Reserved] quired. (b) No tolerance established pursuant [68 FR 62007, Oct. 31, 2003] to paragraph (a)(1) of this section will be set at any level higher than that re- § 556.38 Amoxicillin. flected by the permitted use of the A tolerance of 0.01 part per million is drug. established for negligible residues of (c) Any tolerance required pursuant amoxicillin in milk and in the to this section will, in addition to the uncooked edible tissues of cattle. toxicological considerations, be condi- [49 FR 45422, Nov. 16, 1984] tioned on the availability of a practicable analytical method to determine § 556.40 Ampicillin. the quantity of residue. Such method A tolerance of 0.01 p/m is established must be sensitive to and reliable at the for negligible residues of ampicillin in established tolerance level or, in cer- the uncooked edible tissues of swine tain instances, may be sensitive at a and cattle and in milk. higher level where such level is also deemed satisfactory and safe in light of § 556.50 Amprolium. the toxicity of the drug residue and of Tolerances are established as follows the unlikelihood of such residue’s ex- for residues of amprolium (1-(4-amino- ceeding the tolerance. 2-n- propyl-5-pyrimidinylmethyl)-2- picolinium chloride hydrochloride): Subpart B—Specific Tolerances for (a) In the edible tissues and in eggs of Residues of New Animal Drugs chickens and turkeys: (1) 1 part per million in uncooked § 556.34 Albendazole. liver and kidney. (a) Acceptable daily intake (ADI). The (2) 0.5 part per million in uncooked ADI for total residues of albendazole is muscle tissue. 5 micrograms per kilogram of body (3) In eggs: weight per day. (i) 8 parts per million in egg yolks. (b) Tolerances. The tolerances for (ii) 4 parts per million in whole eggs. albendazole 2-aminosulfone (marker (b) In the edible tissues of calves: residue) are: (1) 2.0 parts per million in uncooked (1) Cattle—(i) Liver (target tissue): 0.2 fat. parts per million (ppm). (2) 0.5 part per million in uncooked (ii) Muscle: 0.05 ppm. muscle tissue, liver, and kidney.

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(c) In the edible tissues of pheasants: § 556.113 Ceftiofur. (1) 1 part per million in uncooked (a) Acceptable daily intake and accept- liver. able single-dose intake—(1) Acceptable (2) 0.5 part per million in uncooked daily intake (ADI). The ADI for total muscle. residues of ceftiofur is 30 micrograms [40 FR 13942, Mar. 27, 1975, as amended at 50 per kilogram of body weight per day. FR 18472, May 1, 1985] (2) Acceptable single-dose intake (ASDI). The ASDI total residues of § 556.52 Apramycin. ceftiofur is 0.830 milligrams per kilo- A tolerance of 0.1 part per million is gram of body weight. The ASDI is the established for parent apramycin amount of total residues of ceftiofur (marker residue) in kidney (target tis- that may safely be consumed in a sin- sue) of swine. The acceptable daily in- gle meal. The ASDI is used to derive take (ADI) for total residues of the tolerance for residues of apramycin is 25 micrograms per kilo- desfuroylceftiofur at the injection site. gram of body weight per day. (b) Tolerances—(1) Poultry, and sheep. A tolerance for residues of ceftiofur in [62 FR 40933, July 31, 1997] edible tissue is not required. (2) Swine. The tolerances for § 556.60 Arsenic. desfuroylceftiofur (marker residue) (a) [Reserved] are: (b) Tolerances. The tolerances for (i) Kidney (target tissue). 0.25 parts per total residue of combined arsenic (cal- million (ppm). culated as As) are: (ii)Liver. 3 ppm. (1) Turkeys—(i) Muscle and eggs: 0.5 (iii) Muscle. 2 ppm. parts per million (ppm). (3) Cattle. The tolerances for (ii) Other edible tissues: 2 ppm. desfuroylceftiofur (marker residue) (2) [Reserved] are: (c) Related conditions of use. See (i) Kidney (target tissue). 0.4 ppm. § 558.369 of this chapter. (ii) Liver. 2 ppm. (iii)Muscle. 1 ppm. [79 FR 10979, Feb. 27, 2014] (iv) Milk. 0.1 ppm. § 556.70 Bacitracin. [63 FR 53579, Oct. 6, 1998, as amended at 68 FR (a) Acceptable daily intake (ADI). The 60296, Oct. 22, 2003; 69 FR 43892, July 23, 2004; ADI for total residues of bacitracin is 71 FR 39546, July 13, 2006] 0.05 milligram per kilogram of body § 556.115 Cephapirin. weight per day. (b) Tolerances. The tolerance for resi- A tolerance of 0.02 parts per million dues of bacitracin from zinc bacitracin (ppm) is established for residues of or bacitracin methylene disalicylate in cephapirin in the milk and 0.1 ppm in uncooked edible tissues of cattle, the uncooked edible tissues of dairy swine, chickens, turkeys, pheasants, cattle. and quail, and in milk and eggs is 0.5 [40 FR 57454, Dec. 10, 1975] part per million. § 556.120 Chlorhexidine. [65 FR 70791, Nov. 28, 2000] A tolerance of zero is established for § 556.100 Carbadox. residues of chlorhexidine in the uncooked edible tissues of calves. A tolerance of 30 parts per billion is established for residues of quinoxaline- § 556.150 Chlortetracycline. 2-carboxylic acid (marker residue) in liver (target tissue) of swine. (a) Acceptable daily intake (ADI). The ADI for total residues of tetracyclines [63 FR 13337, Mar. 19, 1998] including chlortetracycline, oxytetracycline, and tetracycline is 25 § 556.110 Carbomycin. micrograms per kilogram of body A tolerance of zero is established for weight per day. residues of carbomycin in the uncooked (b) Tolerances. (1) Tolerances are es- edible tissues of chickens. tablished for the sum of tetracycline

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residues in tissues of beef cattle, non- § 556.167 Colistimethate. lactating dairy cows, calves, swine, A tolerance for residues of sheep, chickens, turkeys, and ducks, of colistimethate in the edible tissues of 2 parts per million (ppm) in muscle, 6 chickens is not required. ppm in liver, and 12 ppm in fat and kidney. [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 ADI for total residues of danofloxacin [63 FR 52158, Sept. 30, 1998, as amended at 63 is 2.4 micrograms per kilogram of body FR 57246, Oct. 27, 1998] weight per day. § 556.160 Clopidol. (b) Tolerances—(1) Cattle—(i) Liver (the target tissue). The tolerance for par- Tolerances for residues of clopidol ent danofloxacin (the marker residue) (3,5-dichloro-2,6-dimethyl-4-pyridinol) is 0.2 part per million (ppm). in food are established as follows: (ii) Muscle. The tolerance for parent (a) In cereal grains, vegetables, and danofloxacin (the marker residue) is 0.2 fruits: 0.2 part per million. ppm. (b) In chickens and turkeys: (2) [Reserved] (1) 15 parts per million in uncooked [67 FR 78973, Dec. 27, 2002] liver and kidney. (2) 5 parts per million in uncooked § 556.170 Decoquinate. muscle. (a) Acceptable daily intake (ADI). The (c) In cattle, sheep, and goats: ADI for total residues of decoquinate is (1) 3 parts per million in uncooked 75 micrograms per kilogram of body kidney. weight per day. (2) 1.5 parts per million in uncooked (b) Tolerances. Tolerances are estab- liver. lished for residues of decoquinate in (3) 0.2 part per million in uncooked the uncooked, edible tissues of chick- muscle. ens, cattle, and goats as follows: (d) In swine: 0.2 part per million in (1) 1 part per million (ppm) in skel- uncooked edible tissues. etal muscle. (e) In milk: 0.02 part per million (neg- (2) 2 ppm in other tissues. ligible residue). [64 FR 10103, Mar. 2, 1999]

§ 556.163 Clorsulon. § 556.180 Dichlorvos. (a) Acceptable daily intake (ADI). The A tolerance of 0.1 part per million is ADI for total residues of clorsulon is 8 established for negligible residues of micrograms per kilogram of body dichlorvos (2,2-dichlorovinyl dimethyl weight per day. phosphate) in the edible tissues of (b) Tolerances—(1) Cattle—(i) Kidney swine. (the target tissue). The tolerance for parent clorsulon (the marker residue) is § 556.185 Diclazuril. 1.0 part per million. (a) Acceptable daily intake (ADI). The (ii) Muscle. The tolerance for parent ADI for total residues of diclazuril is 25 clorsulon (the marker residue) is 0.1 micrograms per kilogram of body part per million. weight per day. (2) [Reserved] (b) Tolerances—(1) Chickens—(i) Liver. [66 FR 35544, July 6, 2001] The tolerance for parent diclazuril (the marker residue) is 3 parts per million § 556.165 Cloxacillin. (ppm). (ii) Muscle. The tolerance for parent A tolerance of 0.01 part per million is diclazuril (the marker residue) is 0.5 established for negligible residues of ppm. cloxacillin in the uncooked edible tis- (iii) Skin/fat. The tolerance for parent sues of cattle and in milk. diclazuril (the marker residue) is 1 [40 FR 28792, July 9, 1975] ppm.

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(2) Turkeys—(i) Liver. The tolerance § 556.227 Eprinomectin. for parent diclazuril (the marker res- (a) Acceptable daily intake (ADI). The idue) is 3 ppm. ADI for total residues of eprinomectin (ii) Muscle. The tolerance for parent is 10 micrograms per kilogram of body diclazuril (the marker residue) is 0.5 weight per day. ppm. (b) Tolerances. The tolerances for (iii) Skin/fat. The tolerance for parent eprinomectin B1a (marker residue) are: diclazuril (the marker residue) is 1 (1) Cattle—(i) Liver (target tissue): 1.5 ppm. parts per million. [64 FR 35923, July 2, 1999. Redesignated and (ii) Muscle: 100 parts per billion (ppb). amended at 66 FR 62917, Dec. 4, 2001] (iii) Milk: 12 ppb. (2) [Reserved] § 556.200 Dihydrostreptomycin. (c) Related conditions of use. See Tolerances are established for resi- §§ 522.814 and 524.814 of this chapter. dues of dihydrostreptomycin in [63 FR 59715, Nov. 5, 1998, as amended at 76 uncooked, edible tissues of cattle and FR 72619, Nov. 25, 2011] swine of 2.0 parts per million (ppm) in kidney and 0.5 ppm in other tissues, § 556.230 Erythromycin. and 0.125 ppm in milk. Tolerances for residues of erythromycin in food are established as fol- [59 FR 41977, Aug. 16, 1994] lows: § 556.225 Doramectin. (a) 0.1 part per million in uncooked edible tissues of beef cattle and swine. (a) Acceptable daily intake (ADI). The (b) Zero in milk. ADI for total residues of doramectin is (c) 0.025 part per million in uncooked 0.75 microgram per kilogram of body eggs. weight per day. (d) 0.125 part per million (negligible (b) Tolerances—(1) Cattle. A tolerance residue) in uncooked edible tissues of of 100 parts per billion is established chickens and turkeys. for parent doramectin (marker residue) in liver (target tissue) and of 30 parts [40 FR 13942, Mar. 27, 1975, as amended at 58 FR 43795, Aug. 18, 1993] per billion for parent doramectin in muscle. § 556.240 Estradiol and related esters. (2) Swine. A tolerance is established No residues of estradiol, resulting for parent doramectin (marker residue) from the use of estradiol or any of the in liver (target tissue) of 160 parts per related esters, are permitted in excess billion. of the following increments above the [63 FR 68184, Dec. 10, 1998] concentrations of estradiol naturally present in untreated animals: § 556.226 Enrofloxacin. (a) In uncooked edible tissues of heif- (a) Acceptable daily intake (ADI). The ers, steers, and calves: ADI for total residues of enrofloxacin (1) 120 parts per trillion for muscle. is 3 micrograms per kilogram of body (2) 480 parts per trillion for fat. weight per day. (3) 360 parts per trillion for kidney. (b) Tolerances. The tolerances for (4) 240 parts per trillion for liver. enrofloxacin are: (b) [Reserved] (1) Cattle—(i) Liver (target tissue). 0.1 [49 FR 13873, Apr. 9, 1984, as amended at 56 part per million (ppm) desethylene FR 67175, Dec. 30, 1991; 76 FR 16291, Mar. 23, ciprofloxacin (the marker residue). 2011] (ii) [Reserved] § 556.260 Ethopabate. (2) Swine—(i) Liver (target tissue). 0.5 ppm enrofloxacin (the marker residue). Tolerance for residues of ethopabate (ii) [Reserved] converted to metaphenetidine are established in the edible tissues of chick- (c) Related conditions of use. See ens as follows: § 522.812 of this chapter. (a) 1.5 parts per million in uncooked [73 FR 21819, Apr. 23, 2008] liver and kidney.

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(b) 0.5 part per million in uncooked 100 parts per billion in the injection muscle. site. As used in this section ‘‘tolerance’’ refers to a concentration of a § 556.273 Famphur. marker residue in the target tissue se- Tolerances are established for resi- lected to monitor for total residues of dues of famphur including its oxygen the drug in the target animal, and analog in or on meat, fat, or meat by- ‘‘safe concentrations’’ refer to the con- products of cattle at 0.1 part per mil- centrations of total residues considered lion. safe in edible tissues. [62 FR 55161, Oct. 23, 1997] [49 FR 26716, June 29, 1984]

§ 556.275 Fenbendazole. § 556.283 Florfenicol. (a) Acceptable daily intake (ADI). The (a) Acceptable daily intake (ADI). The ADI for total residues of fenbendazole ADI for total residues of florfenicol is is 40 micrograms per kilogram of body 10 micrograms per kilogram of body weight per day. weight per day. (b) Tolerances—(1) Cattle—(i) Liver (b) Tolerances—(1) Cattle—(i) Liver (the target tissue). The tolerance for par- (the target tissue). The tolerance for ent fenbendazole (the marker residue) florfenicol amine (the marker residue) is 0.8 part per million (ppm). is 3.7 parts per million (ppm). (ii) Muscle. The tolerance for parent (ii) Muscle. The tolerance for fenbendazole (the marker residue) is 0.4 florfenicol amine (the marker residue) ppm. is 0.3 ppm. (iii) Milk. The tolerance for (2) Swine—(i) Liver (the target tissue). fenbendazole sulfoxide metabolite (the The tolerance for parent florfenicol marker residue in cattle milk) is 0.6 (the marker residue) is 2.5 ppm. ppm. (ii) Muscle. The tolerance for parent (2) Swine—(i) Liver (the target tissue). florfenicol (the marker residue) is 0.2 The tolerance for parent fenbendazole ppm. (the marker residue) is 6 ppm. (3) Catfish. The tolerance for (ii) Muscle. The tolerance for parent florfenicol amine (the marker residue) fenbendazole (the marker residue) is 2 in muscle (the target tissue) is 1 ppm. ppm. (4) Salmonids. The tolerance for (3) Turkeys—(i) Liver (the target tis- florfenicol amine (the marker residue) sue). The tolerance for fenbendazole in muscle/skin (the target tissues) is 1 sulfone (the marker residue) is 6 ppm. ppm. (ii) Muscle. The tolerance for (c) Related conditions of use. See fenbendazole sulfone (the marker res- §§ 520.955, 522.955, 522.956, and 558.261 of idue) is 2 ppm. this chapter. (4) Goats—(i) Liver (the target tissue). The tolerance for parent fenbendazole [76 FR 16291, Mar. 23, 2011] (the marker residue) is 0.8 ppm. (ii) Muscle. The tolerance for parent § 556.286 Flunixin. fenbendazole (the marker residue) is 0.4 (a) Acceptable daily intake (ADI). The ppm. ADI for total residues of flunixin is 0.72 micrograms per kilogram of body [65 FR 20733, Apr. 18, 2000, as amended at 65 FR 41588, July 6, 2000; 65 FR 50914, Aug. 22, weight per day. 2000] (b) Tolerances—(1) Cattle. The tolerance for flunixin free acid (the marker § 556.277 Fenprostalene. residue) is: A tolerance for marker residue of (i) Liver (the target tissue). 125 parts fenprostalene in cattle is not needed. per billion (ppb). The safe concentrations for the total (ii) Muscle. 25 ppb. residues of fenprostalene in the (iii) Milk: 2 ppb 5-hydroxy flunixin. uncooked edible tissues of cattle are 10 (2) Swine. The tolerance for flunixin parts per billion in muscle, 20 parts per free acid (the marker residue) is: billion in liver, 30 parts per billion in (i) Liver (the target tissue). 30 ppb. kidney, 40 parts per billion in fat, and (ii) Muscle. 25 ppb.

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(c) Related conditions of use. See § 556.308 Halofuginone hydrobromide. §§ 522.956 and 522.970 of this chapter. The marker residue selected to mon- [63 FR 38750, July 20, 1998, as amended at 69 itor for total residues of halofuginone FR 60309, Oct. 8, 2004; 70 FR 70999, Nov. 25, hydrobromide in broilers and turkeys 2005; 76 FR 16291, Mar. 23, 2011] is parent halofuginone hydrobromide and the target tissue selected is liver. § 556.292 Gamithromycin. A tolerance is established in broilers of (a) Acceptable Daily Intake (ADI). The 0.16 part per million and in turkeys of ADI for total residues of 0.13 part per million for parent gamithromycin is 10 micrograms per halofuginone hydrobromide in liver. kilogram of body weight per day. These marker residue concentrations (b) Tolerances. The tolerances for in liver correspond to total residue gamithromycin (the marker residue) concentrations of 0.3 part per million are: in liver. The safe concentrations for (1) Cattle—(i) Liver (the target tissue): total residues of halofuginone 500 parts per billion (ppb). hydrobromide in the uncooked edible (ii) Muscle. 150 ppb. tissues of broilers and turkeys are 0.1 (2) [Reserved] part per million in muscle, 0.3 part per (c) Related conditions of use. See million in liver, and 0.2 part per mil- § 522.1014 of this chapter. lion in skin with adhering fat. As used in this section, ‘‘tolerance’’ refers to a [76 FR 57907, Sept. 19, 2011] concentration of a marker residue in § 556.300 Gentamicin sulfate. the target tissue selected to monitor for total residues of the drug in the (a) A tolerance of 0.1 part per million target animal, and ‘‘safe concentra- is established for negligible residues of tions’’ refers to the concentrations of gentamicin sulfate in the uncooked ed- total residues considered safe in edible ible tissues of chickens and turkeys. tissues. (b) Tolerances are established for total residues of gentamicin in edible [54 FR 28052, July 5, 1989, as amended at 56 tissues of swine as follows: 0.1 part per FR 8711, Mar. 1, 1991; 57 FR 21209, May 19, 1992] million in muscle, 0.3 part per million in liver, and 0.4 part per million in fat § 556.310 Haloxon. and kidney. A microbiological deter- minative procedure and an HPLC con- A tolerance of 0.1 part per million is firmatory procedure for gentamicin established for negligible residues of have been developed to assay haloxon (3-chloro-7-hydroxy-4-methyl- gentamicin in kidney at 0.4 ppm. Since coumarin bis(2-chloroethyl) phosphate) residues of gentamicin as the parent in the edible tissues of cattle. compound and total residues are equal, [40 FR 13942, Mar. 27, 1975, as amended at 45 the marker (parent drug) residue con- FR 10333, Feb. 15, 1980] centration of 0.4 ppm in kidney corresponds to 0.4 ppm of total residue. § 556.330 Hygromycin B. A tolerance of zero is established for [48 FR 791, Jan. 7, 1983, as amended at 61 FR 24441, May 15, 1996] residues of hygromycin B in or on eggs and the uncooked edible tissues of § 556.304 Gonadotropin. swine and poultry. (a) Acceptable daily intake (ADI). The § 556.344 Ivermectin. ADI for residues of total gonadotropins (a) Acceptable daily intake (ADI). The (human chorionic gonadotropin and ADI for total residues of ivermectin is pregnant mare serum gonadotropin) is 1 microgram per kilogram of body 42.25 I.U. per kilogram of body weight weight per day. per day. (b) Tolerances—(1) Liver. A tolerance (b) Tolerances. A tolerance for resi- is established for 22,23- dues of gonadotropin in uncooked edi- dihydroavermectin B a (marker res- ble tissues of cattle or of fish is not re- 1 idue) in liver (target tissue) as follows: quired. (i) Cattle. 100 parts per billion. [64 FR 48545, Sept. 7, 1999] (ii) Swine. 20 parts per billion.

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(iii) Sheep. 30 parts per billion. levamisole hydrochloride in the edible (iv) Reindeer. 15 parts per billion. tissues of cattle, sheep, and swine. (v) American bison. 15 parts per billion. § 556.360 Lincomycin. (2) Muscle. Muscle residues are not in- (a) Acceptable daily intake (ADI). The dicative of the safety of other edible ADI for total residues of lincomycin is tissues. A tolerance is established for 25 micrograms per kilogram of body 22,23-dihydroavermectin B1a (marker weight per day. residue) in muscle as follows: (b) Chickens. A tolerance for residues (i) Swine. 20 parts per billion. of lincomycin in chickens is not re- (ii) Cattle. 10 parts per billion. quired. [63 FR 54352, Oct. 9, 1998, as amended at 64 FR (c) Swine. Tolerances for lincomycin 26671, May 17, 1999] of 0.6 part per million in liver and 0.1 part per million in muscle are estab- § 556.346 Laidlomycin. lished. (a) Acceptable daily intake (ADI). The ADI for total residues of laidlomycin is [64 FR 13342, Mar. 18, 1999] 7.5 micrograms per kilogram of body weight per day. § 556.375 Maduramicin ammonium. (b) Tolerance. The tolerance for par- A tolerance is established for resi- ent laidlomycin (the marker residue) dues of maduramicin ammonium in in the liver (the target tissue) of cattle chickens as follows: is 0.2 part per million (ppm). (a) A tolerance for maduramicin am- [68 FR 42590, July 18, 2003] monium (marker residue) in chickens is 0.38 parts per million in fat (target § 556.347 Lasalocid. tissue). A tolerance refers to the concentration of marker residues in the (a) Acceptable daily intake (ADI). The target tissue used to monitor for total ADI for total residues of lasalocid is 10 drug residues in the target animals. micrograms per kilogram of body weight per day. (b) The safe concentrations for total (b) Tolerances—(1) Cattle. The toler- maduramicin ammonium residues in ance for parent lasalocid (the marker uncooked edible chicken tissues are: residue) in liver (the target tissue) is 0.24 parts per million in muscle; 0.72 0.7 part per million (ppm). parts per million in liver; 0.48 parts per (2) Chickens—(i) Skin with adhering fat million in skin; and 0.48 parts per mil- (the target tissue). The tolerance for par- lion in fat. A safe concentration refers ent lasalocid (the marker residue) is 1.2 to the total residue concentration con- ppm. sidered safe in edible tissues. (ii) Liver. The tolerance for parent [54 FR 5229, Feb. 2, 1989] lasalocid (the marker residue) is 0.4 ppm. § 556.380 Melengestrol acetate. (3) Turkeys—(i) Liver (the target tis- A tolerance of 25 parts per billion is sue). The tolerance for parent lasalocid established for residues of the parent (the marker residue) is 0.4 ppm. compound, melengestrol acetate, in fat (ii) Skin with adhering fat. The toler- of cattle. ance for parent lasalocid (the marker residue) is 0.4 ppm. [59 FR 41241, Aug. 11, 1994] (4) Rabbits. The tolerance for parent lasalocid (the marker residue) in liver § 556.410 Metoserpate hydrochloride. (the target tissue) is 0.7 ppm. A tolerance of 0.02 part per million is (5) Sheep. The tolerance for parent established for negligible residues of lasalocid (the marker residue) in liver metoserpate hydrochloride (methyl-o- (the target tissue) is 1.0 ppm. methyl-18-epireserpate hydrochloride) [66 FR 19854, Apr. 18, 2001] in uncooked edible tissues of chickens.

§ 556.350 Levamisole hydrochloride. § 556.420 Monensin. A tolerance of 0.1 part per million is (a) Acceptable daily intake (ADI). The established for negligible residues of ADI for total residues of monensin is

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12.5 micrograms per kilogram of body (c) Related conditions of use. See weight per day. §§ 520.1454 and 522.1450 of this chapter. (b) Tolerances. The tolerances for res- [65 FR 36617, June 9, 2000, as amended at 65 idues of monensin are: FR 76930, Dec. 8, 2000; 70 FR 36338, June 23, (1) Cattle—(i) Liver. 0.10 part per mil- 2005; 70 FR 76163, Dec. 23, 2005] lion (ppm). (ii) Muscle, kidney, and fat. 0.05 ppm. § 556.428 Narasin. (iii) Milk. Not required. (a) Acceptable daily intake (ADI). The (2) Goats—(i) Edible tissues. 0.05 ppm. ADI for total residues of narasin is 5 (ii) [Reserved] micrograms per kilogram of body (3) Chickens, turkeys, and quail. A tol- weight per day. erance for residues of monensin in (b) Tolerances—(1) Chickens (abdominal chickens, turkeys, and quail is not re- fat). The tolerance for parent narasin quired. (the marker residue) is 480 parts per (c) Related conditions of use. See billion. §§ 520.1448 and 558.355 of this chapter. (2) [Reserved] [64 FR 5159, Feb. 3, 1999, as amended at 69 FR [66 FR 23589, May 9, 2001] 68783, Nov. 26, 2004; 72 FR 56897, Oct. 5, 2007]

§ 556.425 Morantel tartrate. § 556.430 Neomycin. A tolerance of 0.7 part per million is (a) Acceptable daily intake (ADI). The established for N-methyl-1,3- ADI for total residues of neomycin is 6 propanediamine (MAPA, marker res- micrograms per kilogram of body idue) in the liver (target tissue) of cat- weight per day. tle and goats. A tolerance for residues (b) Tolerances. Tolerances are estab- of morantel tartrate in milk is not re- lished for residues of parent neomycin quired. in uncooked edible tissues as follows: (1) Cattle, swine, sheep, and goats. 7.2 [59 FR 17922, Apr. 15, 1994] parts per million (ppm) in kidney (target tissue) and fat, 3.6 ppm in liver, and § 556.426 Moxidectin. 1.2 ppm in muscle. (a) Acceptable daily intake (ADI). The (2) Turkeys. 7.2 ppm in skin with ADI for total residues of moxidectin is adhearing fat, 3.6 ppm in liver, and 1.2 4 micrograms per kilogram of body ppm in muscle. weight per day. (3) Milk. A tolerance is established (b) Tolerances—(1) Cattle—(i) Fat (the for residues of parent neomycin of 0.15 target tissue). The tolerance for parent ppm. moxidectin (the marker residue) is 900 parts per billion (ppb). [64 FR 31498, June 11, 1999] (ii) Liver. The tolerance for parent moxidectin (the marker residue) is 200 § 556.440 Nequinate. ppb. A tolerance of 0.1 part per million is (iii) Muscle. The tolerance for parent established for negligible residues of moxidectin (the marker residue) is 50 nequinate in the uncooked edible tis- ppb. sues of chickens. (iv) Milk. The tolerance for parent moxidectin (the marker residue) is 40 § 556.445 Nicarbazin. ppb. A tolerance of 4 parts per million is (2) Sheep—(i) Fat (the target tissue). established for residues of nicarbazin in The tolerance for parent moxidectin uncooked chicken muscle, liver, skin, (the marker residue) is 900 parts per and kidney. billion (ppb). (ii) Liver. The tolerance for parent [42 FR 56729, Oct. 28, 1977] moxidectin (the marker residue) is 200 ppb. § 556.460 Novobiocin. (iii) Muscle. The tolerance for parent Tolerances for residues of novobiocin moxidectin (the marker residue) is 50 are established at 0.1 part per million ppb. in milk from dairy animals and 1 part

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per million in the uncooked edible tis- (b) Beef cattle, dairy cattle, calves, sues of cattle, chickens, turkeys, and swine, sheep, chickens, turkeys, finfish, ducks. and lobster. Tolerances are established for the sum of residues of the [47 FR 18590, Apr. 30, 1982] tetracyclines including chlortetracycline, oxytetracycline, and tetra- § 556.470 Nystatin. cycline, in tissues and milk as follows: A tolerance of zero is established for (1) 2 parts per million (ppm) in mus- residues of nystatin in or on eggs and cle. the uncooked edible tissues of swine (2) 6 ppm in liver. and poultry. (3) 12 ppm in fat and kidney. (4) 0.3 ppm in milk. § 556.480 Oleandomycin. Tolerances are established for neg- [63 FR 57246, Oct. 27, 1998, as amended at 66 ligible residues of oleandomycin in FR 46370, Sept. 5, 2001; 69 FR 6557, Feb. 11, 2004] uncooked edible tissues of chickens, turkeys, and swine at 0.15 part per mil- § 556.510 Penicillin. lion. Tolerances are established for resi- § 556.490 Ormetoprim. dues of penicillin and the salts of penicillin in food as follows: (a) [Reserved] (a) 0.05 part per million (negligible (b) Tolerances. A tolerance of 0.1 part residue) in the uncooked edible tissues per million (ppm) is established for of cattle. negligible residues of ormetoprim in (b) Zero in the uncooked edible tis- uncooked edible tissues of chickens, sues of chickens, pheasants, quail, turkeys, ducks, salmonids, catfish, and swine, and sheep; in eggs; and in milk chukar partridges. or in any processed food in which such [64 FR 26672, May 17, 1999] milk has been used. (c) 0.01 part per million in the § 556.495 Oxfendazole. uncooked edible tissues of turkeys. Cattle: A tolerance is established for [40 FR 13942, Mar. 27, 1975, as amended at 43 total oxfendazole residues in edible FR 32749, July 28, 1978] cattle tissues based on a marker residue concentration of 0.8 part per mil- § 556.513 Piperazine. lion (ppm) fenbendazole in the target A tolerance of 0.1 part per million pi- liver tissue. A fenbendazole concentra- perazine base is established for edible tion of 0.8 ppm in liver corresponds to tissues of poultry and swine. a total safe concentration of oxfendazole residues of 1.7 ppm in liver. [64 FR 23019, Apr. 29, 1999] The safe concentrations of total oxfendazole residues in other uncooked § 556.515 Pirlimycin. edible cattle tissues are: muscle, 0.84 (a) Acceptable daily intake (ADI). The ppm; kidney, 2.5 ppm; and fat, 3.3 ppm. ADI for total residues of pirlimycin is A tolerance refers to the concentration 0.01 milligrams per kilogram of body of marker residue in the target tissue weight per day. selected to monitor for total drug res- (b) Tolerances—(1) Cattle—(i) Liver idue in the target animal. A safe con- (the target tissue). The tolerance for par- centration is the total residue consid- ent pirlimycin (the marker residue) is ered safe in edible tissue. 0.5 part per million (ppm). [55 FR 46943, Nov. 8, 1990] (ii) Muscle. The tolerance for parent pirlimycin (the marker residue) is 0.3 § 556.500 Oxytetracycline. ppm. (iii) Milk. The tolerance for parent (a) The Acceptable daily intake (ADI). pirlimycin (the marker residue in cat- ADI for total tetracycline residues tle milk) is 0.4 ppm. (chlortetracycline, oxytetracycline, (2) [Reserved] and tetracycline) is 25 micrograms per kilogram of body weight per day. [65 FR 61091, Oct. 16, 2000]

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§ 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 (ii) Liver: 15 ppb. 0.005 milligram per kilogram of body (iii) Kidney: 30 ppb. weight per day. (iv) Fat: 30 ppb. (b) [Reserved] (2) [Reserved] (c) Related conditions of use. See [65 FR 70791, Nov. 28, 2000] §§ 522.1940 and 529.1940 of this chapter. § 556.597 Semduramicin. [76 FR 57907, Sept. 19, 2011] (a) Acceptable daily intake (ADI). The § 556.560 Pyrantel tartrate. ADI for total residues of semduramicin Tolerances are established for resi- is 180 micrograms per kilogram of body dues of pyrantel tartrate in edible tis- weight per day. sues of swine as follows: (b) Tolerances—(1) Broiler chickens. (a) 10 parts per million in liver and Tolerances are established for residues kidney. of parent semduramicin in uncooked (b) 1 part per million in muscle. edible tissues of 400 parts per billion (ppb) in liver and 130 ppb in muscle. § 556.570 Ractopamine. (2) [Reserved] (a) Acceptable Daily Intake (ADI). The ADI for total residues of ractopamine [64 FR 48296, Sept. 3, 1999] hydrochloride is 1.25 micrograms per kilogram of body weight per day. § 556.600 Spectinomycin. (b) Tolerances—(1) Cattle—(i) Liver (a) Acceptable daily intake (ADI). The (the target tissue). The tolerance for ADI for total residues of spectinomycin ractopamine hydrochloride (the mark- is 25 micrograms per kilogram of body er residue) is 0.09 parts per million weight per day. (ppm). (b) Chickens and turkeys. A tolerance (ii) Muscle. The tolerance for of 0.1 part per million (ppm) for neg- ractopamine hydrochloride (the mark- ligible residues of spectinomycin in er residue) is 0.03 ppm. uncooked edible tissues of chickens (2) Swine—(i) Liver (the target tissue). The tolerance for ractopamine hydro- and turkeys is established. chloride (the marker residue) is 0.15 (c) Cattle. A tolerance of 4 ppm for ppm. parent spectinomycin (marker residue) (ii) Muscle. The tolerance for in kidney (target tissue) is established. ractopamine hydrochloride (the mark- A tolerance of 0.25 ppm for parent er residue) is 0.05 ppm. spectinomycin in cattle muscle is es- (3) Turkeys—(i) Liver (the target tis- tablished. sue). The tolerance for ractopamine [63 FR 24107, May 1, 1998; 63 FR 38304, July 16, (the marker residue) is 0.45 ppm. 1998] (ii) Muscle. The tolerance for ractopamine (the marker residue) is 0.1 § 556.610 Streptomycin. ppm. Tolerances are established for resi- [68 FR 54659, Sept. 18, 2003, as amended at 73 dues of streptomycin in uncooked, edi- FR 72715, Dec. 1, 2008] ble tissues of chickens, swine, and § 556.580 Robenidine hydrochloride. calves of 2.0 parts per million (ppm) in kidney and 0.5 ppm in other tissues. Tolerances are established for residues of robenidine hydrochloride in ed- [58 FR 47211, Sept. 8, 1993] ible tissues of chickens as follows:

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§ 556.620 Sulfabromomethazine so- sulfamethazine in the uncooked edible dium. tissues of chickens, turkeys, cattle, Tolerances for residues of and swine. sulfabromomethazine sodium in food [47 FR 25323, June 11, 1982] are established as follows: (a) In the uncooked edible tissues of § 556.685 Sulfaquinoxaline. cattle at 0.1 part per million (negligible residue). A tolerance of 0.1 part per million is (b) In milk at 0.01 part per million established for negligible residues of (negligible residue). sulfaquinoxaline in the uncooked edible tissues of chickens, turkeys, calves, [47 FR 30244, July 13, 1982] and cattle. § 556.625 Sodium sulfachloropyrazine [61 FR 24443, May 15, 1996] monohydrate. A tolerance of zero is established for § 556.690 Sulfathiazole. residues of sodium sulfachloropyrazine A tolerance of 0.1 part per million is monohydrate in the uncooked edible established for negligible residues of tissues of chickens. sulfathiazole in the uncooked edible tissues of swine. § 556.630 Sulfachlorpyridazine. A tolerance of 0.1 part per million is § 556.700 Sulfomyxin. established for negligible residues of A tolerance of zero is established for sulfachlorpyridazine in uncooked edi- residues of sulfomyxin (N-sulfomethyl- ble tissues of calves and swine. polymyxin B sodium salt) in uncooked edible tissues from chickens and tur- § 556.640 Sulfadimethoxine. keys. (a) [Reserved] (b) Tolerances. (1) A tolerance of 0.1 § 556.710 Testosterone propionate. part per million (ppm) is established for negligible residues of No residues of testosterone, resulting sulfadimethoxine in uncooked edible from the use of testosterone propio- tissues of chickens, turkeys, cattle, nate, are permitted in excess of the fol- ducks, salmonids, catfish, and chukar lowing increments above the con- partridges. centrations of testosterone naturally (2) A tolerance of 0.01 ppm is estab- present in untreated animals: lished for negligible residues of (a) In uncooked edible tissues of heif- sulfadimethoxine in milk. ers: (1) 0.64 part per billion in muscle. [64 FR 26672, May 17, 1999] (2) 2.6 parts per billion in fat. § 556.650 Sulfaethoxypyridazine. (3) 1.9 parts per billion in kidney. (4) 1.3 parts per billion in liver. Tolerances for residues of sulfaethoxypyridazine in food are es- (b) [Reserved] tablished as follows: [52 FR 27683, July 23, 1987] (a) Zero in the uncooked edible tissues of swine and in milk. § 556.720 Tetracycline. (b) 0.1 part per million (negligible (a) Acceptable daily intake (ADI). The residue) in uncooked edible tissues of ADI for total tetracycline residues cattle. (chlortetracycline, oxytetracycline, § 556.660 Sulfamerazine. and tetracycline) is 25 micrograms per kilogram of body weight per day. A tolerance of zero is established for (b) Tolerances. Tolerances are estab- residues of sulfamerazine (N1-[4-meth- lished for the sum of tetracycline resi- yl-2-pyrimidinyl]sulfanilamide) in the dues in tissues of calves, swine, sheep, uncooked edible tissues of trout. chickens, and turkeys, of 2 parts per § 556.670 Sulfamethazine. million (ppm) in muscle, 6 ppm in liver, and 12 ppm in fat and kidney. A tolerance of 0.1 part per million is established for negligible residues of [63 FR 57246, Oct. 27, 1998]

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§ 556.730 Thiabendazole. (marker compound) in liver (target tissue) of swine. Tolerances are established at 0.1 part per million for negligible residues of [62 FR 12086, Mar. 14, 1997] 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 0.4 microgram per kilogram of body [40 FR 13942, Mar. 27, 1975, as amended at 49 FR 29958, July 25, 1984] weight per day. (b) Tolerances. A tolerance for total § 556.733 Tildipirosin. trenbolone residues in uncooked edible tissues of cattle is not needed. (a) Acceptable Daily Intake (ADI). The ADI for total residues of tildipirosin is [64 FR 18574, Apr. 15, 1999] 50 micrograms per kilogram of body weight per day. § 556.740 Tylosin. (b) Tolerances. The tolerances for Tolerances are established for resi- tildipirosin (the marker residue) are: dues of tylosin in edible products of (1) Cattle—(i) Liver (the target tissue): animals as follows: 10 parts per million. (a) In chickens and turkeys: 0.2 part (ii) [Reserved] per million (negligible residue) in (2) [Reserved] uncooked fat, muscle, liver, and kid- (c) Related conditions of use. See ney. § 522.2460 of this chapter. (b) In cattle: 0.2 part per million (negligible residue) in uncooked fat, [77 FR 39391, July 3, 2012] muscle, liver, and kidney. (c) In swine: 0.2 part per million (neg- § 556.735 Tilmicosin. ligible residue) in uncooked fat, mus- (a) Acceptable daily intake (ADI). The cle, liver, and kidney. ADI for total residues of tilmicosin is (d) In milk: 0.05 part per million (neg- 25 micrograms per kilogram of body ligible residue). weight per day. (e) In eggs: 0.2 part per million (neg- (b) Tolerances—(1) Cattle—(i) Liver ligible residue). (the target tissue). The tolerance for parent tilmicosin (the marker residue) is § 556.741 Tripelennamine. 1.2 parts per million (ppm). A tolerance of 200 parts per billion (ii) Muscle. The tolerance for parent (ppb) is established for residues of tilmicosin (the marker residue) is 0.1 tripelennamine in uncooked edible tis- ppm. sues of cattle and 20 ppb in milk. (2) Swine—(i) Liver (the target tissue). [62 FR 4164, Jan. 29, 1997] The tolerance for parent tilmicosin (the marker residue) is 7.5 ppm. § 556.745 Tulathromycin. (ii) Muscle. The tolerance for parent (a) Acceptable daily intake (ADI). The tilmicosin (the marker residue) is 0.1 ADI for total residues of tulathromycin ppm. is 15 micrograms per kilogram of body (3) Sheep—(i) Liver (the target tissue). weight per day. The tolerance for parent tilmicosin (b) Tolerances—(1) Cattle—(i) Liver (the marker residue) is 1.2 ppm. (the target tissue). The tolerance for CP– (ii) Muscle. The tolerance for parent 60,300 (the marker residue) is 5.5 parts tilmicosin (the marker residue) is 0.1 per million (ppm). ppm. (ii) [Reserved] (2) Swine—(i) Kidney (the target tis- [64 FR 13679, Mar. 22, 1999, as amended at 67 FR 72368, Dec. 5, 2002; 78 FR 52854, Aug. 27, sue). The tolerance for CP–60,300 (the 2013] marker residue) is 15 ppm. (ii) [Reserved] § 556.738 Tiamulin. (c) Related conditions of use. See § 522.2630 of this chapter. A tolerance of 0.6 part per million is established for 8-alpha-hydroxymutilin [70 FR 39918, July 12, 2005]

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§ 556.748 Tylvalosin. § 556.770 Zoalene. (a) Acceptable Daily Intake (ADI). The Tolerances are established for resi- ADI for total residues of tylvalosin is dues of zoalene (3,5-dinitro-o- 47.7 micrograms per kilogram of body toluamide) and its metabolite 3-amino- weight per day. 5-nitro-o-toluamide in food as follows: (b) Tolerances. A tolerance for (a) In edible tissues of chickens: tylvalosin in edible tissues of swine is (1) 6 parts per million in uncooked not required. liver and kidney. (c) Related conditions of use. See (2) 3 parts per million in uncooked § 520.2645 of this chapter. muscle tissue. (3) 2 parts per million in uncooked [77 FR 55415, Sept. 10, 2012] fat. (b) In edible tissues of turkeys: 3 § 556.750 Virginiamycin. parts per million in uncooked muscle (a) Acceptable daily intake (ADI). The tissue and liver. ADI for total residues of virginiamycin is 250 micrograms per kilogram of body PART 558—NEW ANIMAL DRUGS weight per day. FOR USE IN ANIMAL FEEDS (b) Tolerances—(1) Swine. Tolerances are established for residues of Subpart A—General Provisions virginiamycin in uncooked edible tissues of 0.4 part per million (ppm) in Sec. 558.3 Definitions and general considerations kidney, skin, and fat, 0.3 ppm in liver, applicable to this part. and 0.1 ppm in muscle. 558.4 Requirement of a medicated feed mill (2) Broiler chickens and cattle. A toler- license. ance for residues of virginiamycin is 558.5 Requirements for liquid medicated not required. feed. 558.6 Veterinary feed directive drugs. [64 FR 48296, Sept. 3, 1999] 558.15 Antibiotic, nitrofuran, and sulfonamide drugs in the feed of animals. § 556.760 Zeranol. Subpart B—Specific New Animal Drugs For (a) Acceptable daily intake (ADI). The Use in Animal Feeds ADI for total residues of zeranol is 0.00125 milligrams per kilogram of body 558.55 Amprolium. weight per day. 558.58 Amprolium and ethopabate. (b) Tolerances. The tolerances for res- 558.59 Apramycin. idues of zeranol in edible tissues are: 558.76 Bacitracin methylene disalicylate. 558.78 Bacitracin zinc. (1) Cattle. A tolerance is not needed. 558.95 Bambermycins. (2) Sheep. 20 parts per billion. 558.105 [Reserved] (c) Related conditions of use. See 558.115 Carbadox. § 522.2680 of this chapter. 558.128 Chlortetracycline. 558.140 Chlortetracycline and [40 FR 13942, Mar. 27, 1975, as amended at 54 sulfamethazine. FR 31950, Aug. 3, 1989; 67 FR 6867, Feb. 14, 558.145 Chlortetracycline, procaine peni- 2002; 70 FR 15759, Mar. 29, 2005] cillin, and sulfamethazine. 558.175 Clopidol. § 556.765 Zilpaterol. 558.185 Coumaphos. 558.195 Decoquinate. (a) Acceptable daily intake (ADI). The 558.198 Diclazuril. ADI for total residues of zilpaterol is 558.205 Dichlorvos. 0.083 micrograms per kilogram of body 558.235 Efrotomycin. weight per day. 558.248 Erythromycin. (b) Tolerances—(1) Cattle—(i) Liver 558.254 Famphur. 558.258 Fenbendazole. (the target tissue). The tolerance for 558.261 Florfenicol. zilpaterol freebase (the marker residue) 558.265 Halofuginone hydrobromide. is 12 parts per billion (ppb). 558.274 Hygromycin B. (ii) [Reserved] 558.295 Iodinated casein. (2) [Reserved] 558.300 Ivermectin. 558.305 Laidlomycin. [71 FR 53005, Sept. 8, 2006] 558.311 Lasalocid.

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558.325 Lincomycin. (ii) Category II—These drugs require 558.340 Maduramicin. a withdrawal period at the lowest use 558.342 Melengestrol. level for at least one species for which 558.348 Mibolerone. they are approved, or are regulated on 558.355 Monensin. 558.360 Morantel tartrate. a ‘‘no-residue’’ basis or with a zero tol- 558.363 Narasin. erance because of a carcinogenic con- 558.364 Neomycin sulfate. cern regardless of whether a with- 558.365 Nequinate. drawal period is required, or are a vet- 558.366 Nicarbazin. erinary feed directive drug. 558.369 Nitarsone. (2) A ‘‘Type A medicated article’’ is 558.415 Novobiocin. intended solely for use in the manufac- 558.430 Nystatin. ture of another Type A medicated arti- 558.435 Oleandomycin. cle or a Type B or Type C medicated 558.450 Oxytetracycline. 558.455 Oxytetracycline and neomycin. feed. It consists of a new animal 558.460 Penicillin. drug(s), with or without carrier (e.g., 558.464 Poloxalene. calcium carbonate, rice hull, corn, glu- 558.465 Poloxalene free-choice liquid Type C ten) with or without inactive ingredi- feed. ents. The manufacture of a Type A 558.485 Pyrantel. medicated article requires an applica- 558.500 Ractopamine. tion approved under § 514.105 of this 558.515 Robenidine. chapter or an index listing granted 558.550 Salinomycin. under § 516.151 of this chapter. 558.555 Semduramicin. 558.575 Sulfadimethoxine, ormetoprim. (3) A ‘‘Type B medicated feed’’ is in- 558.582 Sulfamerazine. tended solely for the manufacture of 558.586 Sulfaquinoxaline. other medicated feeds (Type B or Type 558.600 Tiamulin. C). It contains a substantial quantity 558.615 Thiabendazole. of nutrients including vitamins and/or 558.618 Tilmicosin. minerals and/or other nutritional in- 558.625 Tylosin. gredients in an amount not less than 25 558.630 Tylosin and sulfamethazine. percent of the weight. It is manufac- 558.635 Virginiamycin. 558.665 Zilpaterol. tured by diluting a Type A medicated 558.680 Zoalene. article or another Type B medicated feed. The maximum concentration of AUTHORITY: 21 U.S.C. 360b, 371. animal drug(s) in a Type B medicated SOURCE: 40 FR 13959, Mar. 27, 1975, unless feed is 200 times the highest continuous otherwise noted. use level for Category I drugs and 100 times the highest continuous use level Subpart A—General Provisions for Category II drugs. The term ‘‘highest continuous use level’’ means the § 558.3 Definitions and general consid- highest dosage at which the drug is ap- erations applicable to this part. proved for continuous use (14 days or (a) Regulations in this part provide more), or, if the drug is not approved for approved uses of drugs and com- for continuous use, it means the high- binations of drugs in animal feeds. Ap- est level used for disease prevention or proved combinations of such drugs are control. If the drug is approved for specifically identified or incorporated multiple species at different use levels, by cross-reference. Unless specifically the highest approved level of use would provided for by the regulations, a com- govern under this definition. The man- bination of two or more drugs is not ufacture of a Type B medicated feed approved. from a Category II, Type A medicated (b) The following definitions apply to article requires a medicated feed mill terms used in this part: license application approved under (1) New animal drugs approved for § 515.20 of this chapter. use in animal feed are placed in two (4) A ‘‘Type C medicated feed’’ is in- categories as follows: tended as the complete feed for the ani- (i) Category I—These drugs require mal or may be fed ‘‘top dressed’’ (added no withdrawal period at the lowest use on top of usual ration) on or offered level in each species for which they are ‘‘free-choice’’ (e.g., supplement) in con- approved. junction with other animal feed. It

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contains a substantial quantity of nu- a VFD drug to another distributor or trients including vitamins, minerals, to the client-recipient of the VFD. and/or other nutritional ingredients. It (10) An ‘‘animal production facility’’ is manufactured by diluting a Type A is a location where animals are raised medicated article or a Type B medi- for any purpose, but does not include cated feed. A Type C medicated feed the specific location where medicated may be further diluted to produce an- feed is made. other Type C medicated feed. The man- (11) An ‘‘acknowledgment letter’’ is a ufacture of a Type C medicated feed written communication provided to a from a Category II, Type A medicated distributor by a consignee who is not article requires a medicated feed mill the ultimate user of medicated feed license application approved under containing a VFD drug. An acknowl- § 515.20 of this chapter. edgment letter affirms that the con- (5) A Type B or Type C medicated signee will not ship such medicated feed manufactured from a drug compo- animal feed to an animal production nent (bulk or ‘‘drum-run’’ (dried crude facility that does not have a VFD, and fermentation product)) requires an ap- will not ship such feed to another dis- plication approved under § 514.105 of tributor without receiving a similar this chapter or an index listing granted written acknowledgment letter. under § 516.151 of this chapter. [51 FR 7392, Mar. 3, 1986, as amended at 52 FR (6) A ‘‘veterinary feed directive 2682, Jan. 26, 1987; 54 FR 51386, Dec. 15, 1989; (VFD) drug’’ is a new animal drug ap- 56 FR 19268, Apr. 26, 1991; 64 FR 63206, Nov. 19, proved under section 512(b) of the Fed- 1999; 65 FR 76929, Dec. 8, 2000; 72 FR 69130, eral Food, Drug, and Cosmetic Act (the Dec. 6, 2007] act) or listed in the index under section 572 of the act for use in or on animal § 558.4 Requirement of a medicated feed. Use of a VFD drug must be under feed mill license. the professional supervision of a li- (a) A feed manufacturing facility censed veterinarian. must possess a medicated feed mill li- (7) A ‘‘veterinary feed directive’’ is a cense in order to manufacture a Type B written statement issued by a licensed or Type C medicated feed from a Cat- veterinarian in the course of the vet- egory II, Type A medicated article. erinarian’s professional practice that (b) The manufacture of the following orders the use of a VFD drug in or on types of feed are exempt from the re- an animal feed. This written statement quired license, unless otherwise speci- authorizes the client (the owner of the fied: animal or animals or other caretaker) (1) Type B or Type C medicated feed to obtain and use the VFD drug in or using Category I, Type A medicated ar- on an animal feed to treat the client’s ticles or Category I, Type B or Type C animals only in accordance with the di- medicated feeds; and rections for use approved or indexed by (2) Type B or Type C medicated feed the Food and Drug Administration using Category II, Type B or Type C (FDA). A veterinarian may issue a VFD medicated feeds. only if a valid veterinarian-client-pa- (c) The use of Type B and Type C tient relationship exists, as defined in medicated feeds shall also conform to § 530.3(i) of this chapter. the conditions of use provided for in (8) A ‘‘medicated feed’’ means a Type subpart B of this part and in § 558.15 of B medicated feed as defined in para- this chapter. graph (b)(3) of this section or a Type C (d) This paragraph identifies each medicated feed as defined in paragraph drug by category, the maximum level (b)(4) of this section. of drug in Type B medicated feeds, and (9) For the purposes of this part, a the assay limits for the drug in Type A ‘‘distributor’’ means any person who medicated articles and Type B and distributes a medicated feed containing Type C medicated feeds, as follows:

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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. Bacitracin methylene disalicylate 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. Erythromycin (thiocyanate salt) .... 85–115 9.25 g/lb (2.04%) ...... <20g/ton 70–115/150–50:>20g/ton 75– 125. 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. 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. Niclosamide ...... 85–120 225g/lb (49.5%)...... 80–120. Nystatin ...... 85–125 5.0 g/lb (1.1%) ...... 75–125. Oleandomycin ...... 85–120 1.125 g/lb (0.25%) ...... <11.25 g/ton 70–130; >11.25 g/ton 75– 125. Oxytetracycline ...... 90–120 20.0 g/lb (4.4%) ...... 75–125/65–135. Penicillin ...... 80–120 10.0 g/lb (2.2%) ...... 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 ...... 95–115 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. 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. 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 7.0 g/lb (1.54%) ...... 70–125. Oxytetracycline ...... 80–120 10.0 g/lb (2.2%) ...... 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

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CATEGORY II—Continued

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

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 Nitarsone ...... 90–110 8.5 g/lb (1.87%) ...... 85–120. 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. Ronnel ...... 85–115 27.2 g/lb (6.0%) ...... 80–120. Sulfadimethoxine ...... 90–110 5.675 g/lb (1.25%) ...... 85–115/75–125. Ormetoprim (5/3) ...... 90–110 3.405 g/lb (0.75%) ...... 85–115. Ormetoprim (5/1) ...... 90–110 17.0 g/lb (3.75%) ...... 85–115. Sulfaethoxypyridazine ...... 95–105 50.0 g/lb (11.0%) ...... 85–115. 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. Penicillin ...... 85–115 5.0 g/lb (1.1%) ...... 85–125/70–130. 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. 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 cated feed is covered by this section are in combination, the Category II re- and by § 510.455. quirements will apply to the combina- (c) What is required for new animal tion drug product. drugs intended for use in liquid feed? Any new animal drug intended for use in [51 FR 7392, Mar. 3, 1986] liquid feed must be approved for such EDITORIAL NOTE: For FEDERAL REGISTER ci- use under section 512 of the Federal tations affecting § 558.4, see the List of CFR Food, Drug, and Cosmetic Act (the act) Sections Affected, which appears in the or index listed under section 572 of the Finding Aids section of the printed volume and at www.fdsys.gov. act. Such approvals under section 512 of the act must be: § 558.5 Requirements for liquid medi- (1) An original NADA, cated feed. (2) A supplemental NADA, or (a) What types of liquid medicated feeds (3) An abbreviated NADA. are covered by this section? This section (d) What are the approval requirements covers the following types of liquid under section 512 of the act for new ani- medicated feed: mal drugs intended for use in liquid feed? (1) Type B feed that is intended for An approval under section 512 of the further manufacture of other medi- act for a new animal drug intended for cated feeds (§ 558.3(b)(3)) or: use in liquid feed must contain the fol- (2) Type C feed that is intended for lowing information: the following: (1) Data, or a reference to data in a (i) Further manufacture of another master file (MF), that shows the rel- Type C feed, or evant ranges of conditions under which (ii) Top-dressing (adding on top of the the drug will be chemically stable in usual ration) (§ 558.3(b)(4)). liquid feed under field use conditions; (b) How is liquid free-choice medicated and feed regulated? Liquid free-choice medi-

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(2) Data, or a reference to data in an to use in liquid feeds? Any product con- MF, that shows that the drug is phys- taining any form of bacitracin, oxytet- ically stable in liquid feed under field racycline, or chlortetracycline, in- conditions; or tended for oral administration via ani- (3) Feed labeling with recirculation mal feed and/or drinking water, and or agitation directions as follows: not approved for use in a liquid medi- (i) For liquid feeds stored in recircu- cated feed must include in its labeling lating tank systems: Recirculate im- the following statement: ‘‘FOR USE IN mediately prior to use for not less than lll ONLY. NOT FOR USE IN LIQ- 10 minutes, moving not less than 1 per- UID MEDICATED FEEDS.’’ The blank cent of the tank contents per minute may be filled in with the words: ‘‘DRY from the bottom of the tank to the top. FEEDS’’, ‘‘DRINKING WATER’’, or Recirculate daily as described even ‘‘DRY FEEDS AND DRINKING when not used. WATER’’. (ii) For liquid feeds stored in me- (i) Can the labeling provisions of para- chanical, air, or other agitation-type graph (h) of this section be waived, and tank systems: Agitate immediately how can I apply for a waiver? (1) The la- prior to use for not less than 10 min- beling provisions of paragraph (h) of utes, creating a turbulence at the bot- this section may be waived if there is tom of the tank that is visible at the evidence to indicate that it is unlikely top. Agitate daily as described even a new animal drug would be used in the when not used. manufacture of a liquid medicated (e) How are chemical and physical sta- feed. bility data to be submitted? The data (2) To obtain a waiver, you must sub- must be submitted as follows: mit a letter requesting a waiver to the (1) Directly in the NADA, Office of New Animal Drug Evaluation (2) By a sponsor, or (HFV–100), Center for Veterinary Medi- (3) To an MF that a sponsor may then cine, Food and Drug Administration, reference in its NADA with written 7500 Standish Pl., Rockville, MD 20855. consent of the MF holder. (3) The letter must include a copy of (f) What will be stated in the published the product label; a description of the approval for a new animal drug intended formulation; and information to estab- for use in liquid feed? The approval of a lish that the physical, chemical, or new animal drug intended for use in other properties of the new animal liquid feed as published in this sub- drug are such that diversion to use in chapter will include the following re- liquid medicated feed is unlikely. quirements: (j) What else do I need to know about (1) The formula and/or specifications the labeling provisions of paragraph (h) of of the liquid medicated feed, where the this section? The labeling provisions of owner of this information requests paragraph (h) of this section may be such publication; and/or implemented without prior approval as (2) A statement that the approval has provided for in § 514.8(c)(3) of this chap- been granted for a proprietary formula ter. and/or specifications. (g) When is a medicated feed mill license [69 FR 30197, May 27, 2004, as amended at 71 required for the manufacture of a liquid FR 74785, Dec. 13, 2006; 72 FR 69131, Dec. 6, medicated feed? An approved medicated 2007] feed mill license is required for the manufacture of the following types of § 558.6 Veterinary feed directive drugs. feeds: (1) All liquid medicated feeds that (a) What conditions must I meet if I contain a Category II drug, and am a veterinarian issuing a veterinary (2) Liquid medicated feeds that con- feed directive (VFD)? tain a Category I drug and use a propri- (1) You must be appropriately li- etary formula and/or specifications. censed. (h) What measures are in place to pre- (2) You must issue a VFD only within vent certain drugs, approved for use in the confines of a valid veterinarian-cli- animal feed or drinking water but not in ent-patient relationship (see definition liquid medicated feed, from being diverted at § 530.3(i) of this chapter).

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(3) You must complete the VFD in of receipt of the facsimile or other writing and sign it or it will be invalid. electronic order. (4) You must include all of the fol- (5) You may not transmit a VFD by lowing information in the VFD or it telephone. will be invalid: (c) What are the VFD recordkeeping (i) You and your client’s name, ad- requirements? dress and telephone and, if the VFD is (1) The VFD feed distributor must faxed, facsimile number. keep the VFD original for 2 years from (ii) Identification and number of ani- the date of issuance. The veterinarian mals to be treated/fed the medicated and the client must keep their copies feed, including identification of the for the same period of time. species of animals, and the location of (2) All involved parties must make the animals. the VFD available for inspection and (iii) Date of treatment, and, if dif- copying by FDA. ferent, date of prescribing the VFD (3) All involved parties (the VFD feed drug. distributor, the veterinarian, and the (iv) Approved or index listed indica- client) must keep VFD’s transmitted tions for use. by facsimile or other electronic means (v) Name of the animal drug. for a period of 2 years from date of (vi) Level of animal drug in the feed, issuance. and the amount of feed required to (4) All involved parties must have a treat the animals in paragraph (a)(4)(ii) copy of the VFD before distribution of of this section. a VFD feed to the ultimate user. (vii) Feeding instructions with the (d) What are the notification require- withdrawal time. ments if I am a distributor of animal (viii) Any special instructions and feed containing a VFD drug? cautionary statements necessary for use of the drug in conformance with (1) You must notify FDA only once, the approval. by letter, that you intend to distribute (ix) Expiration date of the VFD. animal feed containing a VFD drug. (x) Number of refills (reorders) if nec- (i) The notification letter must in- essary and permitted by the approval. clude the complete name and address (xi) Your license number and the of each business site from which dis- name of the State issuing the license. tribution will occur. (xii) The statement: ‘‘Extra-label use, (ii) A responsible person from your (i.e., use of this VFD feed in a manner firm must sign and date the notifica- other than as provided for in the VFD tion letter. drug approval) is strictly prohibited.’’ (iii) You must submit the notifica- (xiii) Any other information required tion letter to the Center for Veterinary by the VFD drug approval regulation. Medicine, Division of Animal Feeds (5) You must produce the VFD in (HFV–220), 7500 Standish Pl., Rockville, triplicate. MD 20855, prior to beginning your first (6) You must issue a VFD only for the distribution. approved or indexed conditions and in- (iv) You must notify the Center for dications for use of the VFD drug. Veterinary Medicine at the above ad- (b) What must I do with the VFD if I dress within 30 days of any change in am a veterinarian? name or business address. (1) You must give the original VFD (2) If you are a distributor who ships to the feed distributor (directly or an animal feed containing a VFD drug through the client). to another consignee-distributor in the (2) You must keep one copy of the absence of a valid VFD, you must ob- VFD. tain an ‘‘acknowledgment letter,’’ as (3) You must give the client a copy of defined in § 558.3(b)(11), from the con- the VFD. signee-distributor. The letter must in- (4) You may send a VFD to the client clude a statement affirming that the or distributor by facsimile or other consignee-distributor has complied electronic means provided you assure with ‘‘distributor notification’’ re- that the distributor receives the origi- quirements of paragraph (d)(1) of this nal signed VFD within 5 working days section.

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(e) What are the additional record- if marketing is to continue during the keeping requirements if I am a dis- interim. New animal drug entities with tributor? antibacterial activity not previously (1) You must keep records of receipt marketed, now pending approval or and distribution of all medicated ani- submitted for approval prior to, on, or mal feed containing a VFD drug. following the effective date of this pub- (2) You must keep these records for 2 lication, shall satisfy such criteria years from date of receipt and distribu- prior to approval. tion. (b) Any person interested in devel- (3) You must make records available oping data which will support retaining for inspection and copying by FDA. approval for such uses of such anti- (f) What cautionary statements are required for VFD drugs and animal biotic, nitrofuran, and sulfonamide feeds containing VFD drugs? All label- drugs pursuant to section 512(l) of the ing and advertising must prominently Federal Food, Drug, and Cosmetic Act and conspicuously display the fol- shall submit to the Commissioner the lowing cautionary statement: ‘‘Cau- following: tion: Federal law limits this drug to (1) By July 19, 1973, records and re- use under the professional supervision ports of completed, ongoing, or planned of a licensed veterinarian. Animal feed studies, including protocols, on the bearing or containing this veterinary tetracyclines, streptomycin, dihydro- feed directive drug shall be fed to ani- streptomycin, penicillin, and the mals only by or upon a lawful veteri- sulfonamides; for all other antibiotics nary feed directive issued by a licensed by October 17, 1973; and for the veterinarian in the course of the vet- nitrofuran drugs by March 4, 1974. The erinarian’s professional practice.’’ Food and Drug Administration encour- [65 FR 76929, Dec. 8, 2000, as amended at 72 ages sponsors to consult with the Cen- FR 69131, Dec. 6, 2007] ter for Veterinary Medicine on protocol design and plans for future studies. § 558.15 Antibiotic, nitrofuran, and sul- (2) By April 20, 1974, data from com- fonamide drugs in the feed of ani- pleted studies on the tetracyclines, mals. streptomycin, dihydrostreptomycin, (a) The Commissioner of Food and the sulfonamides, and penicillin assess- Drugs will propose to revoke currently ing the effect of the subtherapeutic use approved subtherapeutic (increased of the drug in feed on the salmonella rate of gain, disease prevention. etc.) reservoir in the target animal as com- uses in animal feed of antibiotic and pared to that in nonmedicated con- sulfonamide drugs whether granted by trols. Failure to complete the sal- approval of new animal drug applica- monella studies for any of these drugs tions, master files and/or antibiotic or by that time will be grounds for pro- food additive regulations, by no later ceeding to immediately withdraw ap- than April 20, 1975, or the nitrofuran proval. drugs by no later than September 5, 1975, unless data are submitted which (3) By April 20, 1975, data satisfying resolve conclusively the issues con- all other specified criteria for safety cerning their safety to man and ani- and effectiveness, including the effect mals and their effectiveness under spe- on the salmonella reservoir for any an- cific criteria established by the Food tibiotic or sulfonamide drugs and by and Drug Administration based on the September 5, 1975, for the nitrofuran guidelines included in the report of the drugs, approved for subtherapeutic use FDA task force on the use of anti- in animal feeds. Drug efficacy data biotics in animal feeds. All persons or shall be submitted for any feed-use firms previously marketing identical, combination product containing such related, or similar products except the drug and any feed-use single ingredient nitrofuran drugs not the subject of an antibiotic, nitrofuran, or sulfonamide approved new animal drug application not reviewed by the National Academy must submit a new animal drug appli- of Sciences—National Research Coun- cation by July 19, 1973, or by December cil, Drug Efficacy Study covering drugs 4, 1973, in the case of nitrofuran drugs, marketed between 1938 and 1962.

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(4) Progress reports on studies under- (1) Those antibiotic, nitrofuran, and way every January 1 and July 1 until sulfonamide drugs which fail to meet completion. the prescribed criteria for subthera- (c) Failure on the part of any sponsor peutic uses but which are found to be to comply with any of the provisions of effective for the therapeutic purposes paragraph (b) of this section for any of will be permitted in feed only for high- the antibacterial drugs included in level, short-term therapeutic use and paragraph (b)(1) of this section, or in- only by or on the order of a licensed terim results indicating a health haz- veterinarian. ard, will be considered as grounds for (2) Animal feeds containing anti- immediately proceeding to withdraw bacterial drugs permitted to remain in approval of that drug for use in animal use for subtherapeutic purposes shall feeds under section 512(l) of the act in be labeled to include a statement of the case of failure to submit required the quantity of such drugs. records and reports and under section (g) The submission of applications 512(e) where new information shows and data required by paragraphs (a) and (b) of this section is not required that such drug is not shown to be safe. for the continued manufacture of any (d) Criteria based upon the guidelines Type A medicated article which is pro- laid down by the task force may be ob- duced solely from a Type A article that tained from the Food and Drug Admin- is in compliance with the requirements istration, Center for Veterinary Medi- of this section: Provided, That the Type cine, 7500 Standish Pl., Rockville, MD A medicated article contains no drug 20855. ingredient whose use in or on animal (e) Reports as specified in this sec- feed requires an approved application tion shall be submitted to: Food and pursuant to section 512(m) of the act Drug Administration, Center for Vet- and/or where the Type A article is ap- erinary Medicine, Office of New Animal proved by regulation in this part. Drug Evaluation (HFV–100), 7500 Stand- (1) The following antibacterial Type ish Pl., Rockville, MD 20855. A articles manufactured by the des- (f) Following the completion of the ignated sponsors are eligible for in- requirements of paragraphs (a) and (b) terim marketing based on their com- of this section and the studies provided pliance with the requirements of this for therein: section:

Drug sponsor Type A article Species Use levels Indications for use

Fermenta Animal Health Co. .... Bacitracin meth- Chicken turkeys, Sec. 558.76 ...... Sec. 558.76. ylene disalicy- swine, and cat- late. tle.

(2) [Reserved]

[51 FR 8811, Mar. 14, 1986; 51 FR 11014, Apr. 1, 1986, as amended at 51 FR 28547, Aug. 8, 1986; 53 FR 20843, June 7, 1988; 54 FR 37098, Sept. 7, 1989; 54 FR 51386, Dec. 15, 1989; 55 FR 8460, 8462, Mar. 8, 1990; 56 FR 41912, Aug. 23, 1991; 56 FR 64702, Dec. 12, 1991; 57 FR 6476, Feb. 25, 1992; 57 FR 8577, Mar. 11, 1992; 57 FR 14639, Apr. 22, 1992; 58 FR 17515, Apr. 5, 1993; 58 FR 30119, May 26, 1993; 61 FR 51589, Oct. 3, 1996; 64 FR 992, Jan. 7, 1999; 64 FR 37673, July 13, 1999; 71 FR 16221, Mar. 31, 2006; 75 FR 16002, Mar. 31, 2010]

Subpart B—Specific New Animal § 510.600(c) of this chapter for use as in Drugs for Use in Animal Feeds paragraph (d) of this section. (b) Special considerations. Do not use § 558.55 Amprolium. in Type B or Type C medicated feeds containing bentonite. (a) Approvals. Type A medicated arti- (c) Related tolerances. See § 556.50 of cles: 25 percent to No. 016592 in this chapter. (d) Conditions of use—

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(1) Cattle. It is used as follows:

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 meth- Replacement chickens: For devel- Feed according to subtable in 054771 ylene disalicylate opment of active immunity to item (i). Bacitracin methylene 4 to 50. coccidiosis; and for increased disalicylate as provided by No. rate of weight gain and im- 054771 in § 510.600(c) of this proved feed efficiency. 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. § 558.58 Amprolium and ethopabate. (c) Special considerations. Do not use (a) Specifications. Type A medicated in Type B or Type C medicated feeds articles containing: containing bentonite. (1) 25 percent amprolium and 8 per- (d) Related tolerances. See §§ 556.50 and cent ethopabate or 5 percent 556.260 of this chapter. amprolium and 1.6 percent ethopabate;

(e) Conditions of use. It is used in 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.

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

(2) Amprolium 113.5 Lincomycin 2 to 4 ... Broiler chickens: As an aid in the Feed continuously as sole ration; 054771 and ethopabate prevention of coccidiosis; for in- as sole source of amprolium. 3.6. creased rate of weight gain and Not for laying chickens. improved feed efficiency. Lincomycin as provided by No. 054771 in § 510.600(c) of this chapter. (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. methylene disalicylate 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 3.6. 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) Amprolium 113.5 Virginiamycin 15 ..... Broiler chickens; as an aid in the Feed continuously as the sole ra- 066104 and ethopabate prevention of coccidiosis where tion; as sole source of 36.3. severe exposure to coccidiosis amprolium. Do not feed to lay- from Eimeria acervulina, E. ing chickens. Not for chickens maxima, and E. brunetti is likely over 16 weeks of age. to occur; for increased rate of Virginiamycin as provided by No. weight gain and improved feed 066104 in § 510.600(c) of this efficiency. chapter. (8) Amprolium 113.5 Virginiamycin 5 to Broiler chickens; as an aid in the Feed continuously as the sole ra- 066104 and ethopabate 15. prevention of coccidiosis where tion; as sole source of 36.3. severe exposure to coccidiosis amprolium. Do not feed to lay- from Eimeria acervulina, E. ing chickens. Not for chickens maxima, and E. brunetti is likely over 16 weeks of age. to occur; for increased rate of Virginiamycin as provided by No. weight gain. 066104 in § 510.600(c) of this chapter. (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. (10) Amprolium 227 Chlortetracycline For chickens where immunity to Do not feed to chickens pro- 054771 and ethopabate 100 to 200. coccidiosis is not desired; pre- ducing eggs for human con- 3.6. vention of coccidiosis; control of sumption. Feed for 7 to 14 infectious synovitis caused by days. Mycoplasma synoviae susceptible to chlortetracycline.

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

(11) Amprolium 227 Chlortetracycline For chickens where immunity to In low calcium feed containing 054771 and ethopabate 200 to 400. coccidiosis is not desired; pre- 0.8% dietary calcium and 1.5% 3.6. vention of coccidiosis; control of sodium sulfate; feed continu- chronic respiratory disease ously as sole ration for 7 to 14 (CRD) and air sac infection days; do not feed to chickens caused by M. gallisepticum and producing eggs for human con- E. coli susceptible to chlortetra- sumption. cycline.

[41 FR 10990, Mar. 15, 1976]

EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 558.58, see the List of CFR Sec- tions Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§ 558.59 Apramycin. (2) [Reserved] (a) Approvals. Type A articles to [51 FR 9190, Mar. 18, 1986] sponsors identified in § 510.600(c) of this chapter as follows: § 558.76 Bacitracin methylene disalicy- (1) 000986 for 75 grams apramycin (as late. apramycin sulfate) per pound for use as (a) Approvals. Type A medicated arti- in paragraph (d)(1) of this section. cles: 10, 25, 30, 40, 50, 60, or 75 grams per (2) [Reserved] pound to 054771 in § 510.600(c) of this (b) [Reserved] (c) Related tolerances. See § 556.52 of chapter. this chapter. (b) Special considerations. The quan- (d) Conditions of use—(1) Swine—(i) tities of antibiotics are expressed in Amount. 150 grams per ton. terms of the equivalent amount of an- (ii) Indications for use. For control of tibiotic standard. porcine colibacillosis (weanling pig (c) Related tolerances. See § 556.70 of scours) caused by susceptible strains of this chapter. Escherichia coli. (d) Conditions of use. (1) It is used as (iii) Limitations. Use for 14 days. follows: Withdraw 28 days before slaughter.

Bacitracin methylene Combination in disalicylate in grams grams Indications for use Limitations Sponsor per ton per ton

(i) 4 to 50 ...... Chickens, turkeys, and pheas- ...... 054771 ants; increased rate of weight gain and improved feed efficiency 1. (ii) 5 to 20 ...... Quail not over 5 weeks of age; ...... 054771 increased rate of weight gain and improved feed efficiency 1. (iii) 10 to 25 ...... Chickens; for increased egg pro- For first 7 months of production 054771 duction and improved feed efficiency for egg production. (iv) 10 to 30...... Swine: for increased rate of For growing and finishing swine 054771 weight gain and improved feed efficiency. Chlortetracycline ap- Swine; for increased rate of Feed for not more than 14 days; 054771 proximately 400, weight gain and improved bacitracin methylene disalicy- 048164 varying with body feed efficiency; for treatment late provided by No. 054771; weight and food of bacterial enteritis caused by chlortetracycline provided by consumption to Escherichia coli and Sal- Nos. 054771 and 048164 in provide 10 milli- monella choleraesuis and bac- § 510.600(c) of this chapter. grams per pound terial pneumonia caused by of body weight per Pasteurella multocida suscep- day. tible to chlortetracycline.

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Bacitracin methylene Combination in disalicylate in grams grams Indications for use Limitations Sponsor per ton per ton

Swine; for control of porcine pro- Feed for not more than 14 days; 054771 liferative enteropathies (ileitis) chlortetracycline and BMD as caused by Lawsonia provided by 054771 in intracellularis susceptible to § 510.600(c) of this chapter. chlortetracycline. (v) [Reserved] (vi) 50 ...... Broiler chickens; as an aid in the ...... 054771 prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Replacement chickens; as an Feed continuously as sole ration 054771 aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. (vii)–(viii) [Reserved] (ix) 100 to 200 ...... Broiler chickens; as an aid in the ...... 054771 control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Replacement chickens; as an Feed continuously as sole ra- 054771 aid in the control of necrotic tion. Start at first clinical signs enteritis caused or com- of disease, vary dosage based plicated by Clostridium spp. or on severity of infection, admin- other organisms susceptible to ister continuously for 5 to 7 bacitracin. days or as long as clinical signs persist, then reduce medication to prevention level (50 g/t). (x) 200 ...... Turkeys; as an aid in the control ...... 054771 of transmissible enteritis in growing turkeys complicated by organisms susceptible to bacitracin methylene disalicylate. Quail; for the prevention of ul- From Type A medicated articles 054771 cerative enteritis in growing containing 25, 40, or 50 grams quail due to Clostridium of bacitracin methylene disa- colinum susceptible to baci- licylate. Feed continuously as tracin methylene disalicylate. the sole ration. (xi) 250 ...... 1. Growing/Finishing Swine: For As the sole ration. Not for use in 054771 control of swine dysentery as- swine weighing more than 250 sociated with Treponema pounds. Diagnosis should be hyodysenteriae on premises confirmed by a veterinarian with a history of swine dys- when results are not satisfac- entery but where signs of the tory. disease have not yet occurred; or following an approved treatment of the disease condition. 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 a veterinarian when results are not satisfactory. 1 These conditions are NAS/NRC reviewed and found effective. Applications for these uses may not require effectiveness data as specified by § 514.111 of this chapter, but may require bioequivalency and safety information.

(2) It is used as bacitracin methylene (i) Amount. 70 milligrams per head disalicylate in feed for animals as fol- per day. lows:

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(a) Indications for use. Feedlot beef (xi) Narasin as in § 558.363. cattle; reduction in the number of liver (xii) Nicarbazin alone and with condemnations due to abscesses. narasin as in § 558.366. (b) Limitations. Administer continu- (xiii) Nitarsone as in § 558.369. ously throughout the feeding period. (xiv) Robenidine as in § 558.515. (ii) Amount. 250 milligrams per head (xv) Salinomycin as in § 558.550. per day. (xvi) Semduramicin as in § 558.555. (a) Indications for use. Feedlot beef (xvii) Zoalene as in § 558.680. cattle; reduction in the number of liver condemnations due to abscesses. [41 FR 10993, Mar. 15, 1976] (b) Limitations. Administer continu- EDITORIAL NOTE: For FEDERAL REGISTER ci- ously for 5 days then discontinue for tations affecting § 558.76, see the List of CFR subsequent 25 days, repeat the pattern Sections Affected, which appears in the during the feeding period. Finding Aids section of the printed volume (3) Bacitracin methylene disalicylate and at www.fdsys.gov. may also be used in combination with: § 558.78 Bacitracin zinc. (i) Amprolium as in § 558.55. (ii) Amprolium and ethopabate as in (a) Specifications. Type A medicated § 558.58. articles containing bacitracin zinc (iii) Decoquinate as in § 558.195. equivalent to 10, 25, 40, or 50 grams per (iv) Diclazuril as in § 558.198. pound bacitracin. (v) Fenbendazole as in § 588.258. (b) Approvals. See No. 054771 in (vi) Halofuginone as in § 558.265. § 510.600(c) of this chapter. (vii) Hygromycin B as in § 588.274. (c) Related tolerances. See § 556.70 of (viii) Ivermectin as in § 558.300. this chapter. (ix) Lasalocid sodium as in § 558.311. (d) Conditions of use. (1) It is used as (x) Monensin as in § 588.355. follows:

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. (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- (ii) Clopidol as in § 558.175. tle at 35 to 70 milligrams per head per (iii) Decoquinate as in § 558.195. day as follows: (iv) Lasalocid as in § 558.311. (i) To aid in stimulating growth and (v) Monensin as in § 558.355. improving feed efficiency. (vi) Naracin as in § 558.363. (ii) For increased rate of weight gain (vii) Nitarsone as in § 558.369. and improved feed efficiency; see spon- (viii) Robenidine as in § 558.515. sor 054771. (ix) Salinomycin as in § 558.550. (3) Bacitracin zinc may also be used in combination with: [41 FR 10994, Mar. 15, 1976] (i) Amprolium and ethopabate as in EDITORIAL NOTE: For FEDERAL REGISTER ci- § 558.58. tations affecting § 558.78, see the List of CFR

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Sections Affected, which appears in the (b) Special considerations. (1) Finding Aids section of the printed volume Bambermycins liquid Type B feeds may and at www.fdsys.gov. be manufactured from dry bambermycins Type A articles. The § 558.95 Bambermycins. liquid Type B feeds must have a pH of (a) Approvals. See sponsors in 3.8 to 7.5, moisture content of 30 to 45 § 510.600(c) of this chapter for use of percent. Type A medicated articles as in para- (2) The expiration date for the liquid graph (d) of this section: Type B feed is 8 weeks after date of (1) No. 016592: 2, 4, and 10 grams per manufacture. The expiration date for pound for use as in paragraphs (d)(1), the dry Type C feed made from the liq- (d)(2), (d)(3), and (d)(4) of this section. uid Type B feed is 1 week after date of (2) Nos. 012286 and 017790: 2 grams for manufacture. use as in paragraph (d)(2) of this sec- (c) [Reserved] tion and 0.4 and 2 grams per pound for (d) Conditions of use—(1) Chickens. Use use as in paragraph (d)(3). 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, 017790. feed efficiency. ration. (ii) 2 ...... Growing turkeys: For in- Feed continuously as the sole 012286, 016592, 017790. creased rate of weight gain ration. and improved feed efficiency.

(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, 017790. 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, 017790. 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.

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Bambermycins in grams/ton Indications for use Limitations Sponsor

(ii) 2 to 40 ...... Pasture cattle (slaughter, Feed continuously at a rate of 016592. stocker, and feeder cattle, 10 to 40 milligrams per head and dairy and beef replace- per day in at least 1 pound ment heifers): For increased and not more than 10 rate of weight gain. pounds of feed. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/ head/day.

(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. (c) Limitations. Each use in a free- (c)Indications for use. For increased choice Type C medicated feed must be rate of weight gain. the subject of an approved new animal (d) Limitations. For free-choice feed- drug application (NADA) or supple- ing to pasture cattle (slaughter, stock- mental NADA as required by 21 CFR er, and feeder cattle; and beef replace- 510.455. Daily bambermycins intakes in ment heifers). Feed a nonmedicated excess of 20 mg/head/day have not been commercial mineral product for 6 shown to be more effective than 20 mg/ head/day. weeks to stabilize consumption between 2.66 and 10.66 ounces per head per (5) Bambermycins may also be used in combination with: day. Feed continuously to provide 10 to 40 milligrams bambermycins per head (i) Amprolium as in § 558.55. per day. Daily bambermycins intakes (ii) Amprolium and ethopabate as in in excess of 20 mg/head/day have not § 558.58. been shown to be more effective than 20 (iii) Clopidal as in § 558.175. mg/head/day. (iv) Diclazuril as in § 558.198. (iv) Use free-choice Type C medicated (v) Halofuginone as in § 558.265. feeds for pasture cattle (slaughter, (vi) Lasalocid as in § 558.311. stocker, and feeder cattle; and beef re- (vii) Monensin as in § 558.355. placement heifers) as follows: (viii) Narasin alone or with (a) Amount. Feed continuously to pro- nicarbazin as in § 558.363. vide 10 to 40 milligrams of (ix) Nicarbazin as in § 558.366. bambermycins per head per day. (x) Salinomycin as in § 558.550. (b) Indications for use. For increased (xi) Zoalene as in § 558.680. rate of weight gain. [40 FR 13959, Mar. 27, 1975]

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EDITORIAL NOTE: For FEDERAL REGISTER ci- bilitated animals; feed continuously as tations affecting § 558.95, see the List of CFR sole ration. Do not use in complete Sections Affected, which appears in the feeds containing less than 15 percent Finding Aids section of the printed volume and at www.fdsys.gov. crude protein. (4) Amount. Carbadox, 10 to 25 grams § 558.105 [Reserved] per ton of feed; plus oxytetracycline, 10 milligrams per pound of body weight. § 558.115 Carbadox. (i) Indications for use. For treatment (a) Approvals. Type A medicated arti- of bacterial enteritis caused by Esch- cles: 2.2. percent (10 grams per pound) erichia coli and S. choleraesuis suscep- to 066104 in § 510.600(c) of this chapter. tible to oxytetracycline, for treatment (b) Related tolerances. See § 556.100 of of bacterial pneumonia caused by this chapter. Pasteurella multocida susceptible to ox- (c) Special considerations. Do not use ytetracycline; and for increased rate of in Type B or Type C medicated feeds weight gain and improved feed effi- containing bentonite. ciency. (d) Conditions of use. It is used for swine as follows: (ii) Limitations. Feed continuously for (1) Amount per ton. 10–25 grams 7 to 14 days. Not for use in pregnant (0.0011–0.00275 percent). swine or swine intended for breeding (i) Indications for use. For increase in purposes. Do not feed to swine within rate of weight gain and improvement of 42 days of slaughter. feed efficiency. [40 FR 13959, Mar. 27, 1975, as amended at 40 (ii) Limitations. Not for use in preg- FR 45164, Oct. 1, 1975; 40 FR 57798, Dec. 12, nant swine or swine intended for breed- 1975; 42 FR 761, Jan. 4, 1977; 51 FR 7396, Mar. ing purposes. Do not feed to swine 3, 1986; 63 FR 59216, Nov. 3, 1998; 66 FR 47963, within 42 days of slaughter. Sept. 17, 2001; 69 FR 51173, Aug. 18, 2004] (2) Amount per ton. 50 grams (0.0055 percent). § 558.128 Chlortetracycline. (i) Indications for use. For control of (a) Specifications. Type A medicated swine dysentery (vibrionic dysentery, articles containing either chlortetra- bloody scours, or hemorrhagic dysentery); control of bacterial swine en- cycline calcium complex equivalent to teritis (salmonellosis or necrotic enter- chlortetracycline hydrochloride or, for itis caused by Salmonella choleraesuis); products intended for use in milk re- increased rate of weight gain and im- placer, chlortetracycline hydro- proved feed efficiency. chloride. (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, 048164, and 066104: 50 to (3) Amount per ton. Carbadox 50 grams 100 grams per pound (g/lb) of Type A (0.0055 percent) plus pyrantel tartrate, medicated article. 96 grams (0.0106 percent). (2) No. 012286: 50, 90, or 100 grams per (i) Indications for use. For control of pound of Type A medicated article. swine dysentery (vibrionic dysentery, (c) Related tolerances. See § 556.150 of bloody scours, or hemorrhagic dys- this chapter. entery); control of bacterial swine en- (d) Special considerations. (1) In milk teritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis); replacers or starter feed; include on la- aid in the prevention of migration and beling the warning: ‘‘A withdrawal pe- establishment of large roundworm riod has not been established for this (Ascaris suum) infections; aid in the product in preruminating calves. Do prevention of establishment of nodular not use in calves to be processed for worm (Oesophagostomum) infections. veal.’’ (ii) Limitations. Do not feed to swine (2) Manufacture for use in free-choice over 75 pounds; do not feed within 10 feeds as in paragraph (e)(4)(iii) of this weeks of slaughter; consult a veteri- section must conform to § 510.455 of this narian before feeding to severely de- chapter.

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(3) When manufactured for use as in domestic birds, other animals, and paragraph (e)(5)(iv) of this section, in- man. Contact appropriate public health clude on labeling the warning: ‘‘Psit- and regulatory officials.’’ tacosis, avian chlamydiosis, or orni- (e) Conditions of use—(1) Chickens. It thosis is a reportable communicable is used as follows: disease, transmissible between wild and

Chlortetracycline amount Indications for use Limitations Sponsor

(i) 10 to 50 g/ton...... Chickens: For increased rate of weight ...... 054771 gain and improved feed efficiency...... Do not feed to chickens producing eggs 012286, for human consumption.. 054771, 048164, 066104. (ii) 100 to 200 g/ton ...... Chickens: For control of infectious syno- 1. Feed continuously for 7 to 14 d...... 054771. vitis caused by Mycoplasma synoviae ...... susceptible to chlortetracycline.. 2. Feed continuously for 7 to 14 d; do not 012286, feed to chickens producing eggs for 054771, human consumption.. 048164, 066104. (iii) 200 to 400 g/ton ...... Chickens: For the control of chronic res- 1. Feed continuously for 7 to 14 d...... 054771. piratory disease (CRD) and air sac in- ...... fection caused by M. gallisepticum and 2. Feed continuously for 7 to 14 d; do not 012286, Escherichia coli susceptible to chlor- feed to chickens producing eggs for 054771, tetracycline.. human consumption.. 048164, 066104. (iv) 500 g/ton ...... Chickens: For the reduction of mortality 1. Feed for 5 d; 0-day withdrawal time 054771. due to E. coli infections susceptible to when formulated from AUREOMYCIN chlortetracycline.. Type A medicated articles or Type B medicated feeds under NADA 48–761.. 2. Feed for 5 d; withdraw 24 h prior to 012286, slaughter; do not feed to chickens pro- 054771, ducing eggs for human consumption.. 048164, 066104.

(2) Turkeys. It is used as follows:

Chlortetracycline amount Indications for use Limitations Sponsor

(i) 10 to 50 g/ton ...... Growing turkeys: For increased rate of weight Do not feed to turkeys producing eggs 012286, gain and improved feed efficiency.. for human consumption.. 054771, 048164, 066104. (ii) 200 g/ton...... Turkeys: For control of infectious synovitis Feed continuously for 7 to 14 d; do 012286, caused by M. synoviae susceptible to chlor- not feed to turkeys producing eggs 054771, tetracycline.. for human consumption.. 048164, 066104. (iii) 400 g/ton ...... 1. Turkeys: For control of hexamitiasis caused Feed continuously for 7 to 14 d; do 012286, by Hexamita meleagridis susceptible to not feed to turkeys producing eggs 054771, chlortetracycline.. for human consumption.. 048164, 066104...... 2. Turkey poults not over 4 weeks of age: For 012286, reduction of mortality due to paratyphoid 054771, caused by Salmonella typhimurium suscep- 048164, tible to chlortetracycline.. 066104. (iv) 25 mg/lb of body Turkeys: For control of complicating bacterial Feed continuously for 7 to 14 d; do 012286, weight. organisms associated with bluecomb (trans- not feed to turkeys producing eggs 054771, missible enteritis; coronaviral enteritis) sus- for human consumption.. 048164, ceptible to chlortetracycline.. 066104.

(3) Swine. It is used as follows:

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Chlortetracycline amount Indications for use Limitations Sponsor

(i) 10 to 50 g/ton ...... Growing swine: For increased rate of weight ...... 012286, gain and improved feed efficiency.. 054771, 048164, 066104. (ii) 50 to 100 g/ton ...... Swine: For reducing the incidence of cervical ...... 012286, lymphadenitis (jowl abscesses) caused by 054771, Group E. Streptococci susceptible to chlor- 048164, tetracycline.. 066104. (iii) 400 g/ton...... Breeding swine: For the control of lepto- Feed continuously for not more than 012286, spirosis (reducing the incidence of abortion 14 d.. 054771, and shedding of leptospirae) caused by 048164, Leptospira pomona susceptible to chlor- 066104. tetracycline.. (iv) 10 mg/lb of body 1. Swine: For the treatment of bacterial enter- Feed approximately 400 g/t, varying 012286, weight. itis caused by E. coli and S. choleraesuis with body weight and feed con- 054771, and bacterial pneumonia caused by sumption to provide 10 mg/lb per 048164, Pasteurella multocida susceptible to chlor- day. Feed for not more than 14 d; 066104. tetracycline.. withdraw 5 d prior to slaughter for sponsor 012286...... 2. Swine: For the control of porcine prolif- Feed for not more than 14 d...... 054771. erative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline..

(4) Cattle. It is used as follows:

Chlortetracycline amount Indications for use Limitations Sponsor

(i) 0.1 mg/lb of body Calves (up to 250 lb): For increased rate of See paragraph (d)(1) of this section. .. 012286, weight daily.. weight gain and improved feed efficiency.. 054771, 048164, 066104. (ii) 0.5 mg/lb of body Beef cattle (over 700 lb); control of active in- Withdraw 48 h prior to slaughter. To 012286, weight daily.. fection of anaplasmosis caused by sponsor Nos. 054771 and 048164: 054771, Anaplasma marginale susceptible to chlor- zero withdrawal time.. 048164, tetracycline.. 066104. (iii) 0.5 to 2.0 mg/lb of Beef cattle and nonlactating dairy cattle: As In free-choice cattle feeds such as 054771. body weight daily.. an aid in the control of active infection of feed blocks or salt-mineral mixes anaplsmosis caused by A. marginale sus- manufactured from approved Type ceptible to chlortetracycline.. A articles. See paragraph (d)(2) of this section.. (iv) 10 mg/lb of body 1. Calves, beef and nonlactating dairy cattle; Feed approximately 400 g/ton, varying 012286, weight daily. treatment of bacterial enteritis caused by E. with body weight and feed con- 048164, coli and bacterial pneumonia caused by P. sumption to provide 10 mg/lb per 066104. multocida organisms susceptible to chlor- day. Treat for not more than 5 d; in tetracycline.. feed including milk replacers; withdraw 10 d prior to slaughter. To sponsor No. 048164: zero withdrawal time. See paragraph (d)(1) of this section...... 2. Calves (up to 250 lb): For the treatment See paragraph (d)(1) of this section. .. 012286, of bacterial enteritis caused by E. coli sus- 054771, ceptible to chlortetracycline.. 048164, 066104. (v) 500 to 4,000 g/ton ...... Calves, beef and nonlactating dairy cattle; Feed continuously for not more than 5 054771. treatment of bacterial enteritis caused by E. days to provide 10 mg/lb body coli and bacterial pneumonia caused by P. weight per day. To sponsor No. multocida organisms susceptible to chlor- 054771 under NADA 046–699: 24-h tetracycline.. withdrawal time. To sponsor No. 054771 under NADA 048–761: zero withdrawal time.. (vi) 4,000 to 20,000 g/ton Calves, beef and nonlactating dairy cattle; As a top dress, varying with body 054771. treatment of bacterial enteritis caused by E. weight and feed consumption, to coli and bacterial pneumonia caused by P. provide 10 mg/lb per day. Treat for multocida organisms susceptible to chlor- not more than 5 days. See para- tetracycline.. graph (d)(1) of this section.. (vii) 25 to 70 mg/head/day Calves (250 to 400 lb): For increased rate of See paragraph (d)(1) of this section. .. 012286, weight gain and improved feed efficiency.. 054771, 048164, 066104.

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Chlortetracycline amount Indications for use Limitations Sponsor

(viii) 70 mg/head/day ...... Growing cattle (over 400 lb): For increased See paragraph (d)(1) of this section. .. 012286, rate of weight gain, improved feed effi- 054771, ciency, and reduction of liver condemnation 048164, due to liver abscesses.. 066104. (ix) 350 mg/head/day ...... 1. Beef cattle: For control of bacterial pneu- Withdraw 48 h prior to slaughter. To 012286, monia associated with shipping fever com- sponsor No. 054771 under NADA 054771, plex caused by Pasteurella spp. susceptible 046–699: 48-h withdrawal time. To 048164, to chlortetracycline.. sponsor No. 054771 under NADA 066104. 048–761 and No. 048164: zero withdrawal time...... 2. Beef cattle (under 700 lb): For control of Withdraw 48 h prior to slaughter. To 012286, active infection of anaplasmosis caused by sponsor No. 054771 under NADA 054771, A. marginale susceptible to chlortetra- 046–699: 48-h withdrawal time. To 048164, cycline.. sponsor No. 054771 under NADA 066104. 048–761 and No. 048164: zero withdrawal time..

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

Chlortetracycline amount Indications for use Limitations Sponsor

(i) 20 to 50 g/ton ...... Growing sheep; increased rate of weight gain ...... 054771, and improved feed efficiency.. 048164, 066104. (ii) 80 mg/head/day...... Breeding sheep; reducing the incidence of ...... 054771, (vibrionic) abortion caused by 048164, Campylobacter fetus infection susceptible to 066104. chlortetracycline.. (iii) 200 to 400 g/ton ...... Ducks: For the control and treatment of fowl Feed in complete ration to provide 054771. cholera caused by P. multocida susceptible from 8 to 28 mg/lb of body weight to chlortetracycline.. per day depending upon age and severity of disease, for not more than 21 d. Do not feed to ducks producing eggs for human consumption.. (iv) 10 mg/g of finished Psittacine birds (cockatoos, macaws, and par- Feed continuously for 45 d; each bird 054771. feed daily.. rots) suspected or known to be infected should consume daily an amount of with psittacosis caused by Chlamydia medicated feed equal to one fifth of psittaci sensitive to chlortetracycline.. its body weight...... See paragraph (d)(3) of this section. ..

(6) It is used as a free-choice, loose (ii) Amount. 6,000 grams per ton. mineral Type C feed as follows: (iii) Indications for use. Beef and non- (i) Specifications. lactating dairy cattle: As an aid in the control of active infection of International Ingredient Percent Feed No. anaplasmosis caused by Anaplasma marginale susceptible to chlortetra- Dicalcium Phosphate 46.20 6–26–335 cycline. Sodium Chloride (Salt) 15.00 6–04–152 (iv) Limitations. Feed continuously on Magnesium Oxide 10.67 6–02–756 Cottonseed Meal 10.00 5–01–625 a free-choice basis at a rate of 0.5 to 2.0 Trace Mineral/Vitamin Premix1 3.80 mg chlortetracycline per pound of body Calcium Carbonate 3.50 6–01–069 weight per day. Dried Cane Molasses 3.00 4–04–695 (v) Sponsor. See No. 054771 in Potassium Chloride 2.00 6–03–755 § 510.600(c) of this chapter. Mineral Oil 2.00 8–03–123 Iron Oxide 0.50 6–02–431 (7) Chlortetracycline may also be Chlortetracycline Type A medi- 3.33 used in combination with: cated article (90 gram/lb) (i) Amprolium and ethopabate as in 1Content of vitamin and trace mineral premixes may be var- § 558.58. ied. However, they should be comparable to those used for (ii) Bacitracin methylene disalicylate other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with as in § 558.76. 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. (iii) Clopidol as in § 558.175. 651.100 (CPG 7125.18). (iv) Decoquinate as in § 558.195.

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(v) Hygromycin B as in § 558.274. (2) 40 grams of chlortetracycline per (vi) Laidlomycin as in § 558.305. pound, 8.8 percent of sulfamethazine, (vii) Lasalocid as in § 558.311. and penicillin procaine equivalent in (viii) Monensin as in § 558.355. activity to 20 grams of penicillin per (ix) Robenidine as in § 558.515. pound to Nos. 048164 and 054771 in (x) Salinomycin as in § 558.550. § 510.600(c) of this chapter. (xi) Tiamulin as in § 558.600. (b) Specifications. (1) The antibiotic [41 FR 10995, Mar. 15, 1976] substance refers to the antibiotic or feed-grade antibiotic. EDITORIAL NOTE: For FEDERAL REGISTER ci- (2) The antibiotic activities are ex- tations affecting § 558.128, see the List of CFR Sections Affected, which appears in the pressed in terms of the appropriate an- Finding Aids section of the printed volume tibiotic standards. and at www.fdsys.gov. (3) Type C medicated feed contains in each ton, 100 grams of chlortetra- § 558.140 Chlortetracycline and cycline, 50 grams of penicillin as pro- sulfamethazine. caine penicillin, and 100 grams of (a) Approvals. Type A medicated arti- sulfamethazine. cles: 35 grams of chlortetracycline per (c) Related tolerances. See §§ 556.150, pound with 7.7 percent (35 grams) of 556.510, and 556.670 of this chapter. sulfamethazine to Nos. 054771 and 048164 (d) Conditions of use. (1) It is adminis- in § 510.600(c) of this chapter. tered to swine in a Type C feed for re- (b) Related tolerances. See §§ 556.150 duction of the incidence of cervical ab- and 556.670 of this chapter. scesses; treatment of bacterial swine (c) It is used in feed for beef cattle as enteritis (salmonellosis or necrotic en- follows: teritis caused by Salmonella choleraesuis (1) Amount per head per day. Chlor- and vibrionic dysentery); prevention of tetracycline, 350 milligrams plus these diseases during times of stress; sulfamethazine, 350 milligrams. maintenance of weight gains in the (2) Indications for use. Aid in the presence of atrophic rhinitis; growth maintenance of weight gains in the promotion and increased feed effi- presence of respiratory disease such as ciency in swine weighing up to 75 shipping fever. pounds. (3) Limitations. Feed for 28 days, with- (2) Withdraw 15 days prior to slaugh- draw 7 days prior to slaughter. A with- ter. drawal period has not been established for this product in pre-ruminating [40 FR 13959, Mar. 27, 1975, as amended at 43 calves. Do not use in calves to be proc- FR 19385, May 5, 1978; 47 FR 39814, Sept. 10, 1982; 48 FR 30615, July 5, 1983; 51 FR 7396, essed for veal. Mar. 3, 1986; 52 FR 2684, Jan. 26, 1987; 56 FR [61 FR 35954, July 9, 1996, as amended at 64 14019, Apr. 5, 1991; 61 FR 18082, Apr. 24, 1996; FR 15684, Apr. 1, 1999; 66 FR 46706, Sept. 7, 62 FR 14300, Mar. 26, 1997; 63 FR 27845, May 21, 2001; 68 FR 22294, Apr. 28, 2003; 69 FR 62407, 1998; 66 FR 46706, Sept. 7, 2001; 68 FR 47237, Oct. 26, 2004; 79 FR 13544, Mar. 11, 2014] Aug. 8, 2003; 69 FR 62407, Oct. 26, 2004; 79 FR 13544, Mar. 11, 2014] § 558.145 Chlortetracycline, procaine penicillin, and sulfamethazine. § 558.175 Clopidol. (a) Approvals. Type A medicated arti- (a) Specifications. Type A medicated cles: (1) 20 grams of chlortetracycline article containing 25 percent clopidol. per pound, 4.4 percent (20 grams) of (b) Approvals. See No. 016592 in sulfamethazine, and procaine penicillin § 510.600(c) of this chapter. equivalent in activity to 10 grams of (c) [Reserved] penicillin per pound to 054771 in (d) Conditions of use. It is used as fol- § 510.600(c) of this chapter. lows:

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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 methylene Broiler chickens: As in paragraph Feed continuously as the sole 016592 disalicylate 4 to 50. (d)(1) of this section; for increased ration from the time chicks rate of weight gain. are placed in floor pens until slaughter. Do not feed to chickens over 16 weeks of age; bacitracin methylene disalicylate 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) 113.5 ...... Chlortetracycline 100 Broiler and replacement chickens: As Feed continuously as sole ra- 016592 to 200. in paragraph (d)(1) of this section; tion from the time chicks are for control of infectious synovitis placed in floor pens for 7 to caused by Mycoplasma synoviae 14 days. susceptible to chlortetracycline. (6) 113.5 ...... Lincomycin 2 to 4 .... Broiler chickens: As in paragraph Do not feed to chickens over 054771 (d)(1) of this section; for increased 16 weeks of age; as linco- rate of weight gain and improved mycin hydrochloride feed efficiency. monohydrate. (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 (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.

[68 FR 17882, Apr. 14, 2003, as amended at 72 § 558.185 Coumaphos. FR 60551, Oct. 25, 2007; 74 FR 61028, Nov. 23, 2009; 79 FR 10965, 10982, Feb. 27, 2014; 79 FR (a) Specifications. Type A medicated 13545, Mar. 11, 2014] articles containing 1.12, 2.0, 11.2, or 50 percent coumaphos.

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(b) Approvals. See sponsors in to chickens within 10 days of vaccina- § 510.600(c) of this chapter for use as in tion or other conditions of stress; paragraph (e) of this section. treatment of colored breeds of commer- (1) No. 000859 for use of Type A medi- cial layers should be avoided while in cated articles containing 1.12, 2.0, 11.2, production since these breeds appear to or 50 percent coumaphos as in para- be more sensitive to coumaphos than graphs (e)(2) and (e)(3) of this section. white breeds; as sole medication; medi- (2) No. 051311 for use of Type A medi- cations in general should be avoided cated articles containing 1.12 percent while birds are approaching peak pro- coumaphos as in paragraph (e)(1) of duction; such interruption of normal this section. feeding practices may upset the flock (c) Related tolerances. See 40 CFR and lower egg production; diagnosis by 180.189. competent personnel is essential; flock (d) Special considerations. Labeling condition and production records shall bear the following caution state- should be carefully evaluated prior to ment: ‘‘The active ingredient treatment. coumaphos is a cholinesterase inhib- (3) Replacement pullets—(i) Amount. itor. Do not use this product on ani- Coumaphos 36.3 grams per ton (0.004 mals simultaneously or within a few percent). days before or after treatment with or (ii) Indications for use. For control of exposure to cholinesterase-inhibiting capillary worm (Capillaria obsignata) drugs, pesticides, or chemicals.’’ Also, and as an aid in control of common see § 500.25 of this chapter. roundworm (Ascaridia galli) and cecal (e) Conditions of use—(1) Beef and worm (Heterakis gallinae). dairy cattle—(i) Amount. 0.0002 lb. (0.091 (iii) Limitations. In Type C feed; ad- gram) per 100 lb. body weight per day minister before the onset of produc- for 6 consecutive days. Should condition; diagnosis by competent personnel tions warrant, repeat treatment at 30- is essential; administer continuously day intervals. as total feed ration for from 10 to 14 (ii) Indications for use. Control of gas- days; do not feed to chickens under 8 trointestinal roundworms (Haemonchus weeks of age nor within 10 days of vac- spp., Ostertagia spp., Cooperia spp., cination or other conditions of stress; Nematodirus spp., Trichostrongylus spp.). if birds are maintained on contami- (iii) Limitations. Feed in the normal nated litter or exposed to infected grain ration to which the animals are birds, a second 10 to 14 day treatment accustomed, but not in rations con- is recommended but not sooner than 3 taining more than 0.1 percent weeks after the end of the previous coumaphos. Do not feed to animals less treatment; as sole medication; if rein- than 3 months old. Do not feed to sick fection occurs after production begins, animals or animals under stress, such repeat treatment as recommended for as those just shipped, dehorned, cas- laying flocks. trated, or weaned within the last 3 weeks. Do not feed in conjunction with [40 FR 13959, Mar. 27, 1975, as amended at 42 oral drenches or with feeds containing FR 1463, Jan. 7, 1977; 51 FR 7397, Mar. 3, 1986; phenothiazine. 52 FR 2684, Jan. 26, 1987; 61 FR 34729, July 3, (2) Laying chickens—(i) Amount. 1996; 69 FR 70056, Dec. 2, 2004; 70 FR 32489, June 3, 2005; 75 FR 24394, May 5, 2010] Coumaphos 27.2 grams per ton (0.003 percent). § 558.195 Decoquinate. (ii) Indications for use. For control of capillary worm (Capillaria obsignata) (a) Specifications. Type A medicated and as an aid in control of common article containing 6 percent round worm (Ascaridia galli) and cecal decoquinate. worm (Heterakis gallinae). (b) Approvals. See No. 054771 in (iii) Limitations. In Type C feed; ad- § 510.600(c) of this chapter. minister continuously as the total feed (c) Related tolerances. See § 556.170 of ration for 14 days; when reinfection oc- this chapter. curs, treatment may be repeated but (d) Special considerations. (1) Ben- not sooner than 3 weeks after the end tonite should not be used in of the previous treatment; do not feed decoquinate feeds.

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(2) Type A medicated articles may be B feeds having a pH between 5.0 to 6.5 used to manufacture dry or liquid Type and containing a suspending agent to B cattle (including veal calf), sheep, maintain a viscosity of not less than and goat feeds as in paragraphs (e)(2) 500 centipoises. and (e)(3) of this section. (e) Conditions of use. It is used as fol- (3) Type C cattle feeds may be manu- lows: factured from decoquinate liquid Type (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 chickens. 054771 coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti.. (ii) 27.2 ...... Bacitracin methylene Broiler chickens: As in paragraph Feed continuously as sole ra- 054771 disalicylate 4 to 50. (e)(1)(i) of this section; and for in- tion; do not feed to laying creased rate of weight gain and im- chickens. Bacitracin meth- proved feed efficiency.. ylene disalicylate 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) 27.2 ...... Chlortetracycline 100 Chickens: As in paragraph (e)(1)(i) of Feed continuously for 7 to 14 054771 to 200. this section; control of infectious days; do not feed to chickens synovitis caused by Mycoplasma producing eggs for human synoviae susceptible to chlortetra- consumption.. cycline.. (v) 27.2 ...... Chlortetracycline 200 Chickens: As in paragraph (e)(1)(i) of As in paragraph (e)(1)(vi) of 054771 to 400. this section; and for control of this section.. chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and Escherichia coli susceptible to chlortetracycline.. (vi) 27.2...... Lincomycin 2...... Broiler chickens: As in paragraph Feed as sole ration; do not 054771 (e)(1)(ii) of this section.. feed to laying chickens; linco- 054771 mycin provided by No. 000009 in § 510.600(c) of this chapter..

(2) Cattle.

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 food. See paragraph (d)(3) of this section..

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

(ii) 12.9 to 90.8 ... Chlortetracycline 500 Calves, beef, and nonlactating dairy Feed Type C feed to provide 054771 to 4,000.. cattle: As in paragraph (e)(2)(i) of 22.7 mg decoquinate and 1 this section; for treatment of bac- gram chlortetracycline per terial enteritis caused by Esch- 100 lb body weight per day erichia coli; and for treatment of for not more than 5 days. bacterial pneumonia caused by When consumed, feed 22.7 Pasteurella multocida organisms mg decoquinate per 100 lb susceptible to chlortetracycline.. body weight/day for a total of 28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter when manufactured from CTC (chlortetracycline) Type A medicated articles under NADA 141– 147. Zero withdrawal time when manufactured from AU- REOMYCIN (chlortetracycline) Type A medicated articles under NADA 141– 185. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Chlortetra- cycline as provided by No. 054771 in § 510.600(c) of this chapter.. (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. 000986 in § 510.600(c) of this chapter..

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

(iv) 13.6 to 27.2 .. Chlortetracycline ap- Calves, beef and nonlactating dairy Feed Type C feed to provide 054771 proximately 400 cattle: As in paragraph (e)(2)(i) of 22.7 mg decoquinate and 1 048164 (varying with body this section; for treatment of bac- gram (g) chlortetracycline per weight and feed terial enteritis caused by E. coli; 100 lb body weight (0.5 mg/ consumption to and for treatment of bacterial pneu- kg) per day for not more than provide 10 mg/lb monia caused by Pasteurella 5 days. Type C feed may be of body weight per multocida organisms susceptible to prepared from Type B feed day). chlortetracycline.. containing 535.8 to 5,440 g/ ton decoquinate and 6,700 to 80,000 g/ton chlortetracycline. When consumed, feed 22.7 mg decoquinate per 100 lb body weight/day for a total of 28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter when manufactured from chlortetracycline Type A medicated articles under NADA 141–147 and ANADA 200–359. Zero withdrawal time when manufactured from AUREOMYCIN (chlortetracycline) Type A medicated articles under NADA 141–185. Do not feed to calves to be processed for veal. Do not feed to animals producing milk for food. Chlortetracycline as provided by Nos. 054771 and 048164 in § 510.600(c) of this chapter.. (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. 000986, and tylosin as provided by Nos. 000986 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..

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

(vii) 90.9 to 535.7 Chlortetracycline Calves, beef, and nonlactating dairy Feed Type C medicated feed 054771 4,000 to 20,000.. cattle: As in paragraph (e)(2)(i) of supplements as a top dress this section; for treatment of bac- or mix into the daily ration to terial enteritis caused by Esch- provide 22.7 mg decoquinate erichia coli; and for treatment of and 1 gram chlortetracycline bacterial pneumonia caused by per 100 lb body weight per Pasteurella multocida organisms day for not more than 5 days. susceptible to chlortetracycline.. When consumed, feed 22.7 mg decoquinate per 100 lb body weight per day for a total of 28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter when manufactured from CTC (chlortetracycline) Type A medicated articles under NADA 141–147. Zero withdrawal time when manufactured from AUREOMYCIN (chlortetracycline) Type A medicated articles under NADA 141–185. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Chlortetracycline as provided by No. 054771 in § 510.600(c) of this chapter..

(3) Minor species.

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 food...... 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 food.. (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 food..

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

...... 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 food..

[67 FR 72370, Dec. 5, 2002; 68 FR 15372, Mar. 31, 2003; 69 FR 26499, May 13, 2004; 69 FR 52816, Aug. 30, 2004; 69 FR 62407, Oct. 26, 2004; 69 FR 67264, Nov. 17, 2004; 70 FR 2567, Jan. 14, 2005; 78 FR 25183, Apr. 30, 2013; 79 FR 10982, Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014; 79 FR 17860, Mar. 31, 2014]

§ 558.198 Diclazuril. (b) Approvals. See No. 016592 in § 510.600(c) of this chapter. (a) Specifications. Type A medicated (c) Related tolerances. See § 556.185 of article containing 0.2 percent this chapter. diclazuril. (d) Conditions of use. (1) Chickens. For chickens it is used as follows:

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 methylene Broiler chickens: As in item (i) of this As in item (i) of this table. Baci- 016592 disalicylate 4 to 50. table; for increased rate of weight tracin methylene disalicylate 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) 0.91 (1 ppm) Virginiamycin 5 ...... Broiler chickens: As in item (i) of this As in item (i) of this table; 016592 table; for increased rate of weight Virginiamycin provided by gain and improved feed efficiency.. 066104.. (v) 0.91 (1 ppm) Virginiamycin 5 to 15 Broiler chickens: As in item (i) of this As in item (i) of this table. 016592 table; for increased rate of weight Virginiamycin provided by gain.. 066104..

(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 methylene Growing turkeys: As in paragraph As in paragraph (d)(2)(i) of this 016592 disalicylate 4 to (d)(2)(i) of this section; for in- section. Bacitracin methylene 50.. creased rate of weight gain and im- disalicylate provided by No. proved feed efficiency.. 054771 in § 510.600(c) of this chapter..

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

(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..

[64 FR 35923, July 2, 1999, as amended at 65 FR 50134, Aug. 17, 2000; 66 FR 47962, 47963, Sept. 17, 2001; 66 FR 62917, Dec. 4, 2001; 67 FR 34830, May 16, 2002; 67 FR 47257, July 18, 2002; 67 FR 48549, July 25, 2002; 69 FR 9947, Mar. 3, 2004; 72 FR 60552, Oct. 25, 2007; 79 FR 10982, Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014]

§ 558.205 Dichlorvos. ture, and/or fourth-stage larvae of the whipworm (Trichuris suis), nodular (a) Approvals. Type A medicated arti- worm (Oesophagostomum sp. ), large cles: 3.1 and 9.6 percent to 054628 in roundworm (Ascaris suum) and the § 510.600(c) of this chapter. thick stomach worm (Ascarops (b) Special considerations. (1) strongylina) of the gastrointestinal Dichlorvos is to be included in meal or tract. mash or mixed with feed in crumble (ii) Limitations. For swine up to 70 form only after the crumble feed has pounds body weight, feed as sole ration been manufactured. Do not mix in for 2 consecutive days. For swine from feeds to be pelleted nor with pelleted 70 pounds to market weight, feed as feed. Do not soak the feed or admin- sole ration at the rate of 8.4 pounds of ister as wet mash. Feed must be dry feed per head until the medicated feed when administered. Do not use in ani- has been consumed. For boars, open or mals other than swine. Do not allow bred gilts, and sows, feed as sole ration fowl access to feed containing this at the rate of 4.2 pounds per head per preparation or to feces from treated day for 2 consecutive days. animals. (2) Amount per ton. Dichlorvos, 479 (2) Dichlorvos is a cholinesterase in- grams (0.0528 percent). hibitor. Do not use this product in ani- (i) Indications for use. For the re- mals simultaneously or within a few moval and control of mature, imma- days before or after treatment with or ture, and/or fourth-stage larvae of the exposure to cholinesterase-inhibiting whipworm (Trichuris suis), nodular drugs, pesticides, or chemicals. If worm (Oesophagostomum sp. ), large human or animal poisoning should roundworm (Ascaris suum), and the occur, immediately consult a physician thick stomach worm (Ascarops or a veterinarian. Atropine is anti- strongylina) of the gastrointestinal dotal. tract. (3) Labeling for Type A articles and (ii) Limitations. For boars, open or Type B feeds must include a statement bred gilts, and sows, feed as sole ration that containers or materials used in at the rate of 6 pounds per head for one packaging such Type A articles and feeding. Type B feeds are not to be reused and (3) Amount per ton. Dichlorvos, 334–500 all such packaging materials must be grams (0.0366–0.0550 percent). destroyed after the product has been (i) Indications for use. An aid in im- used. proving litter production efficiency by (c) Related tolerances. See § 556.180 of increasing pigs born alive, birth this chapter. weights, survival to market, and rate (d) Conditions of use. It is used in feed of weight gain. Treatment also re- for swine as follows: moves and controls mature, immature (1) Amount per ton. Dichlorvos, 348 and/or fourth stage larvae of whipworm grams (0.0384 percent). (Trichuris suis), nodular worm (i) Indications for use. For the re- (Oesophagostomum supp. ) large moval and control of mature, imma- roundworm (Ascaris suum), and the

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thick stomach worm (Ascarops (B) Limitations. Feed continuously as strongylina) occurring in the gastro- sole ration. Not to be used in swine intestinal tract of the sow or gilt. weighing more than 250 pounds. (ii) Limitations. For pregnant swine; (2) [Reserved] mix into a gestation feed to provide 1,000 milligrams per head daily during [57 FR 38442, Aug. 25, 1992, as amended at 62 last 30 days of gestation. FR 63271, Nov. 28, 1997] [40 FR 13959, Mar. 27, 1975, as amended at 40 § 558.248 Erythromycin. FR 50258, Oct. 29, 1975; 48 FR 46515, Oct. 13, 1983; 51 FR 7397, Mar. 3, 1986; 51 FR 28547, (a) Approvals. Type A medicated arti- Aug. 8, 1986; 52 FR 2684, Jan. 26, 1987; 62 FR cles: (1) 2.2 percent to 061623 in 35077, June 30, 1997; 78 FR 21060, Apr. 9, 2013] § 510.600(c) of this chapter for use as in paragraph (d) of this section. § 558.235 Efrotomycin. (2) 5 and 10 percent to 061623 for use (a) Approvals. Type A medicated arti- in paragraphs (d)(1)(i) and (ii) of this cle: 14.5 grams per pound to 050604 in section. § 510.600(c) of this chapter. (b) Special considerations. The levels (b) Conditions of use—(1) Swine—(i) of antibiotic are expressed in terms of Amount. 3.6 grams per ton. (A) Indications for use. For improved erythromycin master standard. One feed efficiency. gram of erythromycin thiocyanate is (B) Limitations. Feed continuously as equivalent to 0.925 gram of erythro- sole ration. Not to be used in swine mycin master standard. weighing more than 250 pounds. (c) Related tolerances. See § 556.230 of (ii) Amount. 3.6 to 14.5 grams per ton. this chapter. (A) Indications for use. For increased (d) Condition of use. (1) It is used as rate of weight gain. follows:

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

(i) 4.6 to 18.5 ...... Chickens; growth promotion and feed ...... , efficiency. 061623 (ii) 9.25 to 18.5 ...... Turkeys; growth promotion and feed For turkeys not over 12 weeks , efficiency. of age. 061623 (iii) 9.25 to 64.75 ...... Swine; increase in weight gain, im- Starter ration for animals up to 061623 proved feed efficiency in starter 35 lb body weight. pigs (9.25 to 64.75) and grower-finishing pigs (9.25). (iv) 18.5 ...... Laying chickens; aids in increasing ...... 061623 egg production. (v) 92.5 ...... 1. Chickens; as an aid in the preven- Feed for 2 d before stress and 061623 tion of chronic respiratory disease 3 to 6 d after stress; with- during periods of stress. draw 24 h before slaughter. 2. Chickens; as an aid in the preven- Feed for 7 to 14 d; withdraw 24 tion of infectious coryza. h before slaughter. 3. Turkeys; as an aid in the preven- Feed for 2 d before stress and tion of chronic respiratory disease 3 to 6 d after stress. during periods of stress. (vi) 185 ...... 1. Chickens; as an aid in the preven- Feed for 5 to 8 d; do not use in 061623 tion and reduction of lesions and in birds producing eggs for food lowering severity of chronic res- purposes; withdraw 48 h be- piratory disease. fore slaughter. 2. Turkeys; as an aid in the preven- Feed for 5 to 8 d; do not use in 061623 tion and reduction of lesions and in birds producing eggs for food lowering severity of chronic res- purposes. piratory disease.

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(2) In feed for feedlot beef cattle at 37 (ii) Limitations. For beef cattle and milligrams per head per day as an aid nonlactating dairy cows; feed for 30 in stimulating growth and improving days; withdraw from dry dairy cows feed efficiency. and heifers 21 days prior to freshening; withdraw 4 days prior to slaughter. [41 FR 10999, Mar. 15, 1976, as amended at 45 FR 56799, Aug. 26, 1980; 49 FR 31281, Aug. 6, (2) Amount. 2.3 milligrams per pound 1984; 51 FR 7397, Mar. 3, 1986; 52 FR 2684, Jan. body weight per day. 26, 1987; 54 FR 12189, Mar. 24, 1989; 66 FR 14074, (i) Indications for use. For control of Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 79 FR grubs. 10982, Feb. 27, 2014] (ii) Limitations. For beef cattle and nonlactating dairy cows; feed for 10 § 558.254 Famphur. days; withdraw from dry dairy cows (a) Approvals. Type A medicated arti- and heifers 21 days prior to freshening; cles: 13.2 and 33.3 percent to 000061 in withdraw 4 days prior to slaughter. § 510.600(c) of this chapter. [41 FR 11000, Mar. 15, 1976, as amended at 51 (b) Special considerations. Famphur is FR 7397, Mar. 3, 1986; 57 FR 7652, Mar. 4, 1992; a cholinesterase inhibitor. Do not use 62 FR 55161, Oct. 23, 1997; 62 FR 61626, Nov. 19, this product in animals simultaneously 1997] or within a few days before or after treatment with or exposure to cholin- § 558.258 Fenbendazole. esterase-inhibiting drugs, pesticides, or (a) Specifications. Type A medicated chemicals. articles: 4 percent (18.1 grams per (c) Related tolerances. See § 556.273 of pound (g/lb)), 8 percent (36.2 g/lb), and this chapter. 20 percent (90.7 g/lb) fenbendazole. (d) Conditions of use. It is used in the (b) Approvals. See No. 000061 in feed for cattle as follows: § 510.600(c) of this chapter. (1) Amount. 1.1 milligrams per pound (c) Related tolerances. See § 556.275 of body weight per day. this chapter. (i) Indications for use. For control of (d) Special considerations. See § 500.25 grubs and as an aid in control of suck- of this chapter. ing lice. (e) Conditions of use—(1) Turkeys.

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.

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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) 10 to 80 (to Lincomycin 20 ...... As in paragraph (e)(2)(i) of this sec- Feed as sole ration. Do not 000061 provide 9 mg/ tion; for increased rate of gain in feed to swine that weigh kg of body growing-finishing swine. more than 250 pounds (lbs); weight). lincomycin as provided by 054771 in § 510.600(c) of this chapter. (iii) 10 to 80 (to Lincomycin 40 ...... As in paragraph (e)(2)(i) of this sec- Feed as sole ration. Do not 000061 provide 9 mg/ tion; for control of swine dysentery feed to swine that weigh kg of body in animals on premises with a his- more than 250 lbs.; linco- weight). tory of swine dysentery, but where mycin as provided by 054771 symptoms have not yet occurred. in § 510.600(c) of this chapter. (iv) 10 to 80 (to Lincomycin 100 ...... As in paragraph (e)(2)(i) of this sec- Feed as sole ration. Do not use 000061 provide 9 mg/ tion; for the treatment of swine dys- within 6 days of slaughter. kg of body entery. Do not feed to swine that weight). weigh more than 250 lbs.; lincomycin as provided by 054771 in § 510.600(c) of this chapter. (v) 10 to 80 (to Lincomycin 200 ...... As in paragraph (e)(2)(i) of this sec- Feed as sole ration. Do not use 000061 provide 9 mg/ tion; for reduction in the severity of within 6 days of slaughter. kg of body swine mycoplasmal pneumonia Do not feed to swine that weight). caused by Mycoplasma weigh more than 250 pound hyopneumoniae. (lb); lincomycin as provided by 054771 in § 510.600(c) of this chapter. (vi) 10 to 300 (to Bacitracin methylene Growing/finishing swine: As in para- Feed as sole ration. Under con- 054771 provide 9 mg/ disalicylate 10 to graph (e)(2)(i) of this section; for in- ditions of continued exposure kg of body 30. creased rate of weight gain and im- to parasites, retreatment may weight). proved feed efficiency. be needed after 4 to 6 weeks. Bacitracin methylene disalicylate as provided by 054771 in § 510.600(c) of this chapter. (vii) 10 to 300 (to Bacitracin methylene 1. Growing/finishing swine: As in 1. Growing/finishing swine: 054771 provide 9 mg/ disalicylate 250. paragraph (e)(2)(i) of this section; Feed as sole ration. Not for kg of body 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 methylene disalicylate as provided by 054771 in § 510.600(c) of this chapter.

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

...... 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 methylene disalicylate as provided by 054771 in § 510.600(c) of this chapter.

(3) Cattle.

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

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Ingredient1 Percent International Feed No.

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.

(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.

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Amount Species/Class fenbendazole Indications for use Limitations Sponsor

(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.

[66 FR 58935, Nov. 26, 2001, as amended at 68 FR 34534, June 10, 2003; 72 FR 66046, Nov. 27, 2007; 73 FR 58873, Oct. 8, 2008; 74 FR 61517, Nov. 25, 2009; 79 FR 13545, Mar. 11, 2014]

§ 558.261 Florfenicol. veterinarian. See § 558.6 of this chapter for additional requirements. (a) Specifications. Type A medicated (2) The expiration date of veterinary articles containing florfenicol in the feed directives (VFDs) for florfenicol following concentrations: medicated feeds: (1) 40 grams per kilogram for use as (i) For freshwater-reared finfish, in paragraph (e)(1) of this section. must not exceed 15 days from the date (2) 500 grams per kilogram for use as of issuance. in paragraph (e)(2) of this section. (ii) For swine must not exceed 90 (b) Sponsor. See No. 000061 in days from the date of issuance. § 510.600(c) of this chapter. (3) VFDs for florfenicol shall not be (c) Special considerations—(1) Federal refilled. law limits this drug to use under the (d) Related tolerances. See § 556.283 of professional supervision of a licensed this chapter. (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.

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Florfenicol in grams/ton of feed Indications for use Limitations

(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.

(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]

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

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(A) Indications for use. For the pre- eyes, or clothing; keep out of lakes, vention of coccidiosis caused by Eimeria ponds, or streams. tenella, E. necatrix, E. acervulina, E. (ii) Amount per ton. Halofuginone brunetti, E. mivati, and E. maxima; for hydrobromide 1.36 to 2.72 grams plus increased rate of weight gain and im- bacitracin methylene disalicylate 10 to proved feed efficiency. 50 grams. (B) Limitations. Feed continuously as (A) Indications for use. For prevention sole ration; withdraw 6 days before of coccidiosis caused by Eimeria slaughter; do not feed to layers. adenoeides, E. meleagrimitis., and E. (iv) Amount per ton. Halofuginone 2.72 gallopavonis, and for increased rate of grams (0.0003 percent) plus weight gain in growing turkeys. virginiamycin 5 to 15 grams. (B) Limitations. Feed continuously as (A) Indications for use. For the pre- sole ration. Withdraw 7 days before vention of coccidiosis caused by Eimeria slaughter. Do not feed to laying chick- tenella, E. necatrix, E. acervulina, E. ens or water fowl. Keep out of lakes, brunetti, E. mevati, and E. maxima; for ponds, and streams. Halofuginone is increased rate of weight gain. toxic to fish and aquatic life. (B) Limitations. Feed continuously as Halofuginone is an irritant to eyes and sole ration; withdraw 6 days before skin. Avoid contact with skin, eyes, or slaughter; do not feed to layers. clothing. (v) [Reserved] (iii) Amount per ton. 1.36 to 2.72 grams (vi) Amount per ton. Halofuginone 2.72 of halofuginone hydrobromide plus 2 grams (0.0003 percent) plus bacitracin grams of bambermycins. methylene disalicylate 10 to 50 grams. (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 adenoides, E. meleagrimitis, and E. tenella, E. necatrix, E. acervulina, E. gallopavonis, and for increased rate of brunetti, E. mevati, E. maxima and for weight gain in growing turkeys. improved feed efficiency. (B) Limitations. Feed continuously as (B) Limitations. Feed continuously as sole ration. Withdraw 7 days before sole ration; withdraw 5 days before slaughter. Do not feed to laying chick- slaughter; do not feed to layers; avoid ens or waterfowl. Halofuginone contact with skin, eyes, or clothing; hydrobromide is toxic to fish and other keep out of lakes, ponds, or streams. aquatic life. Keep out of lakes, ponds, (vii) Amount per ton. Halofuginone and streams. Halofuginone 2.72 grams (0.0003 percent) plus linco- hydrobromide is an eye and skin irri- mycin 2 to 4 grams. tant. Avoid contact with skin, eyes, (A) Indications for use. For the pre- and clothing. vention of coccidiosis caused by Eimeria (3) It is used in feed for replacement tenella, E. necatrix, E. acervulina, E. cage laying chickens and replacement brunetti, E. mivati, and E. maxima and broiler breeder chickens as follows: for improved feed efficiency. (i) Amount per ton. 2.72 grams. (B) Limitations. Feed continuously as (A) Indications for use. For the pre- sole ration; withdraw 4 days before vention of coccidiosis caused by Eimeria slaughter; do not feed to layers; avoid tenella, E. necatrix, E. acervulina, E. contact with skin, eyes, or clothing; maxima, E. mivati/E. mitis, and E. keep out of lakes, ponds, or streams. brunetti. (viii) [Reserved] (B) Limitations. Feed continuously as (2) It is used in feed for turkeys as sole ration to replacement cage laying follows: chickens until 20 weeks of age. Feed (i) Amount per ton. 1.36 to 2.72 grams. continuously as sole ration to replace- (A) Indications for use. For the pre- ment broiler breeder chickens until 16 vention of coccidiosis in growing tur- weeks of age. Withdraw 4 days before keys caused by Eimeria adenoeides, E. slaughter. Do not feed to laying chick- meleagrimitis, and E. gallopavonis. ens or water fowl. Halofuginone (B) Limitations. Feed continuously as hydrobromide is toxic to fish and sole ration; withdraw 7 days before aquatic life. Keep out of lakes, ponds, slaughter; do not feed to layers or and streams. Halofuginone water fowl; avoid contact with skin, hydrobromide is an irritant to eyes and

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skin. Avoid contact with skin, eyes, § 558.274 Hygromycin B. and clothing. (a) Approvals. See sponsor numbers in (ii) [Reserved] § 510.600(c) of this chapter for Type A [50 FR 33719, Aug. 21, 1985, as amended at 50 medicated articles or Type B medi- FR 42518, Oct. 21, 1985; 51 FR 7397, Mar. 3, cated feeds as follow: 1986; 51 FR 11439, Apr. 3, 1986; 51 FR 14989, (1) No. 000986: 2.4 and 8 grams per Apr. 22, 1986; 51 FR 23737, July 1, 1986; 53 FR pound (g/lb). 1018, Jan. 15, 1988; 53 FR 11065, Apr. 5, 1988; 54 (2) Nos. 012286 and 051311: 2.4 g/lb. FR 11519, Mar. 21, 1989; 54 FR 28052, July 5, (3) No. 017790: 0.6 g/lb. 1989; 59 FR 51498, Oct. 12, 1994; 61 FR 21076, (4) No. 054771: 0.6 and 1.6 g/lb. May 9, 1996; 61 FR 24694, May 16, 1996; 64 FR (b) Related tolerances. See § 556.330 of 42597, Aug. 5, 1999; 65 FR 45712, July 25, 2000; this chapter. 66 FR 47962, Sept. 17, 2001; 71 FR 27956, May (c) Conditions of use. It is used in feed 15, 2006; 79 FR 10982, Feb. 27, 2014] as follows: (1) Chickens—

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

(i) 8 to 12 ...... Chickens: For control of infesta- Withdraw 3 days before slaughter 000986 tion of large roundworms 012286 (Ascaris galli), cecal worms 017790 (Heterakis gallinae), and cap- 054771 illary worms (Capillaria obsignata). (ii) 8 to 12 ...... Tylosin 4 to 50 ...... Chickens: For control of infesta- Withdraw 3 days before slaugh- 000986 tions of large roundworms ter. Tylosin as tylosin phos- (Ascaris galli), cecal worms phate as provided by No. (Heterakis gallinae), and cap- 000986 in § 510.600 of this illary worms (Capillaria chapter. obsignata); growth promotion and feed efficiency.

(2) Swine—

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

(i) 12 ...... Swine: For control of infestation Withdraw 15 days before slaugh- 000986 of large roundworms (Ascaris ter. 012286 suis), nodular worms 017790 (Oesophagostomum dentatum), 054771 and whipworms (Trichuris suis). (ii) 12 ...... Tylosin 10 to 100 ... Swine: For control of infestations Feed continuously as follows: Ani- 000986 of large roundworms (Ascaris mal weight (lbs.): suis), nodular worms Up to 40...20 to 1001 (Oesophagostomum dentatum), 41 to 100...20 to 401 and whipworms (Trichuris suis); 101 to market weight...10 growth promotion and feed effi- to 20 1 ciency. Withdraw 15 days before slaughter. Tylosin as tylosin phosphate as provided by No. 000986 in § 510.600 of this chapter. 1 Amount of Tylosin (g/t).

[79 FR 10982, Feb. 27, 2014] need not include efficacy data as required by § 514.111 of this chapter but § 558.295 Iodinated casein. may require bioequivalency or safety (a) Approvals. See 017762 in § 510.600(c) data. of this chapter. (c) Conditions of use—(1) Ducks—(i) (b) NAS/NRC status. The use of this Amount per ton. 100 to 200 grams. drug is NAS/NRC reviewed and found effective. Applications for these uses

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

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).

(2) 1.8 (to Bacitracin meth- Weaned, growing-finishing swine: For use in swine feed only. Feed as 050604 provide 0.1 ylene disalicylate, As in paragraph (e)(1) of this sec- the only feed for 7 consecutive mg/kg of 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 meth- Weaned, growing-finishing swine: For use in swine feed only. Feed as 050604 provide 0.1 ylene disalicylate, As in paragraph (e)(1) of this sec- the only feed for 7 consecutive mg/kg of 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.

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

(4) 1.8 (to Lincomycin, 20 Weaned, growing-finishing swine: Feed as the only feed for 7 con- 050604 provide 0.1 For treatment and control of gas- secutive days. Not to be fed to mg/kg of trointestinal roundworms (Ascaris swine that weigh more than 250 body suum, adults and fourth-stage lar- lbs. Withdraw 5 days before weight per vae; Ascarops strongylina, adults; slaughter. Also see paragraphs day) Hyostrongylus rubidus, adults and (c)(1) and (c)(2) in § 558.325 of fourth-stage larvae; this chapter. Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis); and for increased rate of weight gain.

(5) 1.8 (to Lincomycin, 40 Weaned, growing-finishing swine: Feed as the only feed for 7 con- 050604 provide 0.1 As in paragraph (e)(4) of this sec- secutive days. Not to be fed to mg/kg of tion; and for control of swine dys- swine that weigh more than 250 body entery on premises with a history lbs. Also see paragraphs (c)(1) weight per of swine dysentery, but where and (c)(2) in § 558.325 of this day) symptoms have not yet occurred. chapter. Withdraw 5 days before slaughter. A separate feed containing 40 g/ton lincomycin may be continued to complete the lincomycin treatment.

(6) 1.8 (to Lincomycin, 100 Weaned, growing-finishing swine: Feed as the only feed for 7 con- 050604 provide 0.1 As in paragraph (e)(4) of this sec- secutive days followed by a sepa- mg/kg of tion; and for treatment of swine rate feed containing 100 g/ton lin- body dysentery. comycin for an additional 14 days weight per to complete the lincomycin treat- day) ment. Withdraw 6 days before slaughter. Not to be fed to swine that weigh more than 250 lbs. Also see paragraphs (c)(1) and (c)(2) in § 558.325 of this chapter.

(7) 1.8 (to Lincomycin, 200 Weaned, growing-finishing swine: Feed as the only feed for 7 con- 050604 provide 0.1 As in paragraph (e)(4) of this sec- secutive days followed by a sepa- mg/kg of tion; and for reduction in severity rate feed containing 200 g/ton lin- body of swine mycoplasmal pneumonia comycin for an additional 14 days weight per caused by Mycoplasma to complete the lincomycin treat- day) hyopneumoniae. ment. Withdraw 6 days before slaughter. Not to be fed to swine that weigh more than 250 lbs. Also see paragraphs (c)(1) and (c)(2) in § 558.325 of this chapter.

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

(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 meth- Pregnant sows: As in paragraph Feed as the only feed for 7 con- 050604 11.8 (to ylene disalicylate, (e)(8) of this section; and for consecutive days. Withdraw 5 days provide 0.1 250 trol of clostridial enteritis caused before slaughter. Feed bacitracin mg/kg of by Clostridium perfringens in methylene disalicylate 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)

[72 FR 37437, July 10, 2007] Recirculate daily as described even when not used. § 558.305 Laidlomycin. (ii) For liquid feeds stored in me- (a) Specifications. Type A medicated chanical, air, or other agitation type articles containing 50 grams tank systems: Agitate immediately laidlomycin propionate potassium per prior to use for not less than 10 min- pound. utes, creating a turbulence at the bot- (b) Approvals. See No. 054771 in tom of the tank that is visible at the § 510.600(c) of this chapter. top. Agitate daily as described even (c) Tolerances. See § 556.346 of this when not used. chapter. (2) The expiration date for the liquid (d) Special considerations. (1) Type B feed is 21 days after date of Laidlomycin liquid Type B feeds may manufacture. The expiration date for be manufactured from dry laidlomycin 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.

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(ii) The safety of laidlomycin propio- (e) Conditions of use. It is used in cat- nate potassium in unapproved species tle being fed in confinement for slaugh- has not been established. ter as follows: (iii) Not for use in animals intended for breeding.

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 ...... Chlortetracycline10 For improved feed efficiency and in- Feed continuously at a rate of 054771 mg/lb body weight. creased rate of weight gain; and for 30 to 75 mg laidlomycin pro- treatment of bacterial enteritis pionate potassium per head caused by Echerichia coli and bac- per day for not more than 5 terial pneumonia caused by days. A withdrawal period Pasteurella multocida organisms has not been established for susceptible to chlortetracycline.. this product in pre-ruminating calves. Do not use in calves to be processed for veal.. (3) 5 ...... Chlortetracycline 350 For improved feed efficiency and in- Feed continuously at a rate of 054771 mg/head/day. creased rate of weight gain; and for 30 to 75 mg laidlomycin pro- control of bacterial pneumonia as- pionate potassium per head sociated with shipping fever com- per day. A withdrawal period plex caused by Pasteurella spp. has not been established for susceptible to chlortetracycline.. this product in pre-ruminating calves. Do not use in calves to be processed for veal.. (4) 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.. (5) 5 to 10 ...... Chlortetracycline 10 For improved feed efficiency; and for Feed continuously at a rate of 054771 mg/pound body treatment of bacterial enteritis 30 to 150 mg laidlomycin weight. caused by E. coli and bacterial propionate potassium per pneumonia caused by P. multocida head per day for not more organisms susceptible to chlortetra- than 5 days. A withdrawal cycline.. period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.. (6) 5 to 10 ...... Chlortetracycline 350 For improved feed efficiency; and for Feed continuously at a rate of 054771 mg/head/day. control of bacterial pneumonia as- 30 to 150 mg laidlomycin sociated with shipping fever com- propionate potassium per plex caused by Pasteurella spp. head per day. A withdrawal susceptible to chlortetracycline.. period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal..

[59 FR 18297, Apr. 18, 1994, as amended at 60 FR 53509, Oct. 16, 1995; 62 FR 9929, Mar. 5, 1997; 63 FR 27845, May 21, 1998; 66 FR 46706, Sept. 7, 2001; 68 FR 13839, Mar. 21, 2003; 68 FR 42590, July 18, 2003; 69 FR 30198, May 27, 2004; 79 FR 13545, Mar. 11, 2014]

§ 558.311 Lasalocid. 054771 for use as in paragraphs (e)(1) (i), (ii), (iii), (iv), and (x) of this section. (a) Specifications. A minimum of 90 percent of lasalocid activity is derived (2) 15 percent activity to No. 066104 as from lasalocid A. provided by No. 054771 for use as in paragraph (e)(1)(v) of this section. (b) Approvals. Type A medicated articles approved for sponsors identified in (3) 15, 20, 33.1, and 50 percent activity § 510.600(c) of this chapter for use as in to No. 054771 for use in cattle feeds as paragraph (e) of this section as follows: in paragraphs (e)(1)(vi), (vii), (ix), (xi), (xii), and (xv) of this section, and for (1) 3.0, 3.3, 3.8, 4.0, 4.3, 4.4, 5.0, 5.1, 5.5, use in sheep as in paragraph (e)(1)(viii) 5.7, 6.0, 6.3, 6.7, 7.2, 7.5, 8.0, 8.3, 10.0, 12.5, of this section. 15, 20, and 50 percent activity to No.

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(4) 15 percent activity to No. 054771 and contains a suspending agent(s) suf- for use in Type C rabbit feeds as in ficient to maintain a viscosity of not paragraph (e)(1)(xvi) of this section and less than 300 centipoises per second for for use in ruminant free-choice Type C 3 months. feeds as in paragraphs (e)(2), (e)(3), and (3) If a manufacturer is unable to (e)(4) of this section. meet the requirements of paragraph (5) 15 and 20 percent activity to Nos. (d)(1) or (d)(2) of this section, the man- 012286 and 017800 for use in free-choice ufacturer may secure approval of a mineral feeds for cattle as in paragraph positionally stable liquid feed by: (e)(1)(xviii) of this section. (i) Either filing a new animal drug (6) 20 percent activity as a liquid application for the product or estab- Type A article to No. 054771 for use in lishing a master file containing data to cattle feeds as in paragraphs (e)(1)(vi), support the stability of its product; (e)(1)(vii), (e)(1)(ix), (e)(1)(xi), (e)(1)(xii), (ii) Authorizing the agency to ref- and (e)(3) of this section, and for use in erence and rely upon the data in the sheep feeds as in paragraph (e)(1)(viii) master file to support approval of a of this section. supplemental new animal drug applica- (7) 20 percent activity to No. 054771 tion to establish physical stability; and for use as follows: (iii) Requesting the sponsor of an ap- (i) Chukar partridges as in paragraph proved new animal drug application to (e)(1)(xiii). file a supplement to provide for use of (ii) Turkeys as in paragraph its lasalocid Type A article in the man- (e)(1)(xiv). ufacture of the liquid feed specified in (iii) Rabbits as in paragraph the appropriate master file. If the data (e)(1)(xvi). demonstrate the stability of the liquid (8) [Reserved] feed described in the master file, the (9) 15 percent activity to No. 068287 supplemental new animal drug applica- for use in free-choice protein blocks for tion will be approved. The approval cattle as in paragraphs (e)(1)(xix) of will provide a basis for the individual this section. liquid feed manufacturer to manufac- (c) Related tolerance. See § 556.347 of ture under a medicated feed license the this chapter. liquid mediated feed described in the (d) Special considerations. (1) Type C master file. A manufacturer who seeks cattle and sheep feeds may be manufac- to market a physically unstable tured from lasalocid liquid Type B lasalocid liquid feed with mixing direc- feeds which have a pH of 4.0 to 8.0 and tions different from the standard direc- bear appropriate mixing directions as tions established in paragraph (d)(1) of follows: this section may also follow this proce- (i) For liquid feeds stored in recircu- dure. lating tank systems: Recirculate im- (4) If adequate information is sub- mediately prior to use for no less than mitted to show that a particular liquid 10 minutes, moving not less than 1 per- feed containing lasalocid is stable out- cent of the tank contents per minute side the pH of 4.0 to 8.0, the pH restric- from the bottom of the tank to the top. tion described in paragraphs (d)(1) and Recirculate daily as described even (d)(2) of this section may be waived. when not used. (5) Required label statements: (ii) For liquid feeds stored in me- (i) For liquid Type B feed (cattle and chanical, air, or other agitation-type sheep): Mix thoroughly with grain and/ tank systems: Agitate immediately or roughage prior to feeding. Feeding prior to use for not less than 10 min- undiluted, mixing errors, or inadequate utes, creating a turbulence at the bot- mixing (recirculation or agitation) tom of the tank that is visible at the may result in an excess lasalocid con- top. Agitate daily as described even centration which could be fatal to cat- when not used. tle and sheep. Do not allow horses or (2) A physically stable lasalocid liq- other equines access to Type A articles uid feed will not be subject to the re- or Type B feeds containing lasalocid as quirements for mixing directions pre- ingestion may be fatal. Safety of scribed in paragraph (d)(1) of this sec- lasalocid for use in unapproved species tion provided it has a pH of 4.0 to 8.0 has not been established.

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(ii) For Type A articles or Type B not use in calves to be processed for feeds (cattle and sheep): Feeding undi- veal. luted or mixing errors may result in an (6) Lasalocid Type A medicated arti- excess lasalocid concentration which cles containing lasalocid dried fer- could be fatal to cattle and sheep. Do mentation residue are for use in cattle not allow horses or other equines ac- and sheep feed only. cess to Type A articles or Type B feeds (7) Each use in a free-choice Type C containing lasalocid as ingestion may cattle feed as in paragraphs (e)(1)(xii) be fatal. Safety of lasalocid for use in and (e)(1)(xviii) of this section must be unapproved species has not been established. the subject of an approved NADA or (iii) For Type A articles, Type B or supplemental NADA as provided in Type C feeds (cattle): A withdrawal pe- § 510.455 of this chapter. riod has not been established for this (e)(1) Conditions of use. It is used as product in preruminating calves. Do follows:

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. 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.. (iii) 68 (0.0075 Lincomycin 2 Broiler or fryer chickens; for the pre- For broiler and fryer chickens 054771 pct). (0.00022 pct). vention of coccidiosis caused by only; feed continuously as Eimeria mivati, E. brunetti, E. sole ration; withdraw 5 d be- tenella, E. acervulina, E. maxima, fore slaughter; Type C feed and E. necatrix; for increased rate must be used within 4 weeks of weight gain and improved feed of manufacture; as linco- efficiency. mycin hydrochloride monohydrate. (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 methylene disalicylate pro- rate of weight gain and improved vided by No. 054771 in feed efficiency. § 510.600(c) of this chapter. (v) 68 (0.0075 Virginiamycin 20 ...... For prevention of coccidiosis caused For broiler and fryer chickens 054771 pct) to 113 by Eimeria tenella E. necatrix, E. only; feed continuously as (0.0125 pct). acervulina, E. brunetti, E. mivati, sole ration; do not feed to and E. maxima, and for increased laying chickens; lasalocid so- rate of weight gain and improved dium provided by No. 054771 feed efficiency. in § 510.600(c) of this chapter. (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. Oxytetracycline 7.5 .. Cattle: for improved feed efficiency In Type C feeds, for beef cattle 054771 and reduction of incidence and se- fed in confinement for verity of liver abscesses. slaughter; feed continuously at 100 to 360 mg/head/day lasalocid and 75 mg/head/ day oxytetracycline. As monoalkyl (C8¥C18) trimethyl ammonium oxytetracycline.

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

(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. Oxytetracycline 7.5 .. Cattle: for improved feed efficiency, In Type C feeds, for beef cattle 054771 increased rate of weight gain, and fed in confinement for reduction of incidence and severity slaughter; feed continuously of liver abscesses. at 250 to 360 mg/head/day lasalocid and 75 mg/head/ day oxytetracycline. As monoalkyl (C8¥C18) trimethyl ammonium oxytetracycline. (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 methylene di- E. brunetti, E. mivati, and E. maxi- salicylate provided by No. ma; and for improved feed effi- 054771 in § 510.600(c) of this ciency. chapter. (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..

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

...... 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 methylene Growing turkeys; for prevention of Feed continuously as sole ra- 054771 disalicylate 4 to 50. coccidiosis caused by E. tion. Bacitracin methylene di- meleagrimitis, E. gallopavonis, and salicylate as provided by No. E. adenoeides; for increased rate of 054771 in § 510.600(c) of this weight gain and improved feed effi- chapter.. ciency...... Virginiamycin 10 to Growing turkeys; for prevention of Feed continuously as sole ra- 054771 20. coccidiosis caused by E. tion. As lasalocid sodium pro- meleagrimitis, E. gallopavonis, and vided by 063238 and E. adenoeides, and for increased virginiamycin provided by rate of weight gain and improved 066104.. feed efficiency.. (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) 10 to 30 ...... Chlortetracycline 25 1. Cattle fed in confinement for Feed continuously in complete 054771 to 100. slaughter: For improved feed effi- feed at a rate of 350 mg ciency; and for control of bacterial chlortetracycline and not less pneumonia associated with ship- than 100 mg nor more than ping fever complex caused by 360 mg of lasalocid sodium Pasteurella spp. susceptible to activity per head per day.. chlortetracycline...... 2. Cattle under 700 pounds fed in Feed continuously in complete 054771 confinement for slaughter: For im- feed at a rate of 350 mg proved feed efficiency; and for con- chlortetracycline and not less trol of active infection of than 100 mg nor more than anaplasmosis caused by 360 mg of lasalocid sodium Anaplasma marginale susceptible activity per head per day.. to chlortetracycline.. (xxi) 10 to 30 ...... Chlortetracycline 500 Cattle fed in confinement for slaugh- Feed continuously in complete 054771 to 2000. ter: For improved feed efficiency; feed for not more than 5 and for treatment of bacterial enter- days to provide 10 mg chlor- itis caused by E. coli and bacterial tetracycline per lb body pneumonia caused by P. multocida weight per day and not less organisms susceptible to chlortetra- than 100 mg nor more than cycline.. 360 mg of lasalocid sodium activity per head per day.. (xxii) 25 to 30 ..... Chlortetracycline 25 1. Cattle fed in confinement for Feed continuously in complete 054771 to 42.2. slaughter: For increased rate of feed at a rate of 350 mg weight gain and improved feed effi- chlortetracycline and not less ciency; and for control of bacterial than 250 mg nor more than pneumonia associated with ship- 360 mg of lasalocid sodium ping fever complex caused by activity per head per day.. Pasteurella spp. susceptible to chlortetracycline..

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

...... 2. Cattle under 700 pounds fed in Feed continuously in complete 054771 confinement for slaughter: For in- feed at a rate of 350 mg creased rate of weight gain and im- chlortetracycline and not less proved feed efficiency; and for con- than 250 mg nor more than trol of active infection of 360 mg of lasalocid sodium anaplasmosis caused by activity per head per day.. Anaplasma marginale susceptible to chlortetracycline.. (xxiii) 25 to 30 .... Chlortetracycline 500 Cattle fed in confinement for slaugh- Feed continuously in complete 054771 to 1200. ter: For increased rate of weight feed for not more than 5 gain and improved feed efficiency; days to provide 10 mg chlor- and for treatment of bacterial enter- tetracycline per lb body itis caused by E. coli and bacterial weight per day and not less pneumonia caused by P. multocida than 250 mg nor more than organisms susceptible to chlortetra- 360 mg of lasalocid sodium cycline.. activity per head per day.. (xxiv) 30 to 181.8 Chlortetracycline 25 1. Beef cattle under 700 pounds: For Hand feed continuously at a 054771 to 2800. control of coccidiosis caused by rate of 350 mg chlortetra- Eimeria bovis and E. zuernii; and cycline per head per day and for control of active infection of 1 mg lasalocid per 2.2 lb anaplasmosis caused by body weight per day with a Anaplasma marginale susceptible maximum of 360 mg to chlortetracycline.. lasalocid per head per day...... 2. Beef cattle up to 800 pounds: For Hand feed continuously at a 054771 control of coccidiosis caused by rate of 350 mg chlortetra- Eimeria bovis and E. zuernii; and cycline per head per day and for control of bacterial pneumonia 1 mg lasalocid per 2.2 lb associated with shipping fever com- body weight per day with a plex caused by Pasteurella spp. maximum of 360 mg susceptible to chlortetracycline.. lasalocid per head per day.. (xxv) 30 to 181.8 Chlortetracycline 500 Cattle up to 800 pounds: For control Hand feed continuously for not 054771 to 4000. of coccidiosis caused by Eimeria more than 5 days to provide bovis and E. zuernii; and for treat- 10 mg chlortetracycline per lb ment of bacterial enteritis caused body weight per day and 1 by E. coli and bacterial pneumonia mg lasalocid per 2.2 lb body caused by P. multocida organisms weight per day with a max- susceptible to chlortetracycline.. imum of 360 mg lasalocid per head per day.. (xxvi) 30 to 600 .. Chlortetracycline 25 1. Pasture cattle (slaughter, stocker, Hand feed continuously at a 054771 to 700. feeder cattle, and beef replacement rate of 350 mg chlortetra- heifers): for increased rate of cycline and not less than 60 weight gain; and for control of bac- mg or more than 300 mg terial pneumonia associated with lasalocid per head daily in at shipping fever complex caused by least 1 lb of feed. Intakes of Pasteurella spp. susceptible to lasalocid in excess of 200 chlortetracycline.. mg/head/day have not been shown to be more effective than 200 mg/head/day...... 2. Pasture cattle under 700 pounds Hand feed continuously at a 054771 (slaughter, stocker, feeder cattle, rate of 350 mg chlortetra- and beef replacement heifers): for cycline and not less than 60 increased rate of weight gain; and mg or more than 300 mg for control of active infection of lasalocid per head daily in at anaplasmosis caused by least 1 lb of feed. Intakes of Anaplasma marginale susceptible lasalocid in excess of 200 to chlortetracycline.. mg/head/day have not been shown to be more effective than 200 mg/head/day.. (xxvii) 30 to 600 .. Chlortetracycline 25 Pasture cattle over 700 pounds Hand feed continuously at a 054771 to 1100. (slaughter, stocker, feeder cattle, rate of 0.5 mg chlortetra- and beef replacement heifers): For cycline per lb body weight increased rate of weight gain; and per day and not less than 60 for control of active infection of mg or more than 300 mg anaplasmosis caused by lasalocid per head daily in at Anaplasma marginale susceptible least 1 lb of feed. Intakes of to chlortetracycline.. lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day..

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

(xxviii) 30 to 600. Chlortetracycline 500 Pasture cattle (slaughter, stocker, Hand feed continuously for not 054771 to 4000.. feeder cattle, and dairy and beef re- more than 5 days to provide placement heifers): For increased 10 mg chlortetracycline per lb rate of weight gain; and for treat- body weight per day and not ment of bacterial enteritis caused less than 60 mg or more than by E. coli and bacterial pneumonia 300 mg lasalocid per head caused by P. multocida organisms daily in at least 1 lb of feed. susceptible to chlortetracycline.. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/ day..

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

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).

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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 (slaughter, stocker, feeder cattle, and (i) Specifications.

Ingredient Percent International feed No.

Monocalcium phosphate (21% P) ...... 57 .70 6–01–082 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. amendment could not be incorporated due to (iii) Indications for use. Pasture cattle inaccurate amendatory instruction. (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): § 558.325 Lincomycin. For increased rate of weight gain. In- (a) Approvals. Type A articles and takes of lasalocid in excess of 200 mg/ Type B feeds approved for sponsors in head/day have not been shown to be § 510.600(c) of this chapter for specific more effective than 200 mg/head/day. uses as in paragraph (d) of this section (iv) Limitations. Feed continuously on as follows: a free-choice basis at a rate of 60 to 300 (1) No. 054771 for 20 and 50 grams per mg lasalocid per head per day. pound. (v) Sponsor. See No. 054771 in (2) No. 051311 for 2.5 and 8 grams per § 510.600(c) of this chapter. pound. (5) Lasalocid may also be used in (b) Related tolerances. See § 556.360 of combination with: this chapter. (i) Melengestrol acetate alone or in (c) Special considerations—(1) Labeling combination with tylosin as in § 558.342. of Type A medicated articles and Type (ii) [Reserved] B and Type C medicated feeds containing lincomycin shall bear the fol- [41 FR 44382, Oct. 8, 1976] lowing directions: ‘‘CAUTION: Do not EDITORIAL NOTE: For FEDERAL REGISTER ci- allow rabbits, hamsters, guinea pigs, tations affecting § 558.311, see the List of CFR horses, or ruminants access to feeds Sections Affected, which appears in the containing lincomycin. Ingestion by Finding Aids section of the printed volume and at www.fdsys.gov. these species may result in severe gastrointestinal effects.’’ EDITORIAL NOTE: At 79 FR 13545, Mar. 11, 2014, § 558.311 was amended; however, the

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(2) Labeling of Type A medicated ar- Type C medicated feeds containing lin- ticles and Type B and Type C medi- comycin intended for use in swine shall cated feeds containing lincomycin in- bear the following directions: tended for use in swine shall bear the (i) No. 054771: ‘‘CAUTION: The effects following directions: ‘‘CAUTION: Occa- of lincomycin on swine reproductive sionally, swine fed lincomycin may performance, pregnancy, and lactation within the first 2 days after the onset have not been determined. Not for use of treatment develop diarrhea and/or in swine intended for breeding when swelling of the anus. On rare occasions, lincomycin is fed at 20 grams per ton of some pigs may show reddening of the complete feed.’’ skin and irritable behavior. These conditions have been self-correcting with- (ii) No. 051311:‘‘CAUTION: Not to be in 5 to 8 days without discontinuing fed to swine that weigh more than 250 the lincomycin treatment.’’ lb.’’ (3) Labeling of Type A medicated ar- (d) Conditions of use—(1) Chickens. It ticles and single-ingredient Type B and is used in feed as follows:

Lincomycin grams/ ton Indications for use Limitations Sponsor

(i) 2...... Broilers: For control of necrotic enteritis As lincomycin hydrochloride monohydrate...... 054771 caused by Clostridium spp. or other susceptible organisms.. (ii) 2 to 4 ...... Broilers: For increased rate of weight gain and As lincomycin hydrochloride monohydrate...... 054771 improved feed efficiency..

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

Lincomycin grams/ ton Indications for use Limitations Sponsor

(i) 20 ...... Growing-finishing swine: For increased rate of Feed as sole ration...... 054771 weight gain.. (ii) 40 ...... 1. For control of swine dysentery...... Feed as sole ration; for use in swine on prem- 054771 ises with a history of swine dysentery but 051311 where symptoms have not yet occurred, or following use of lincomycin at 100 grams (g)/ton for treatment of swine dysentery...... 2. For control of porcine proliferative Feed as sole ration, or following use of linco- 054771 enteropathies (ileitis) caused by Lawsonia mycin at 100 g/ton for control of porcine intracellularis.. proliferative enteropathies (ileitis).. (iii) 100 ...... 1. For treatment of swine dysentery...... Feed as sole ration for 3 weeks or until signs 054771 of disease disappear.. 051311 ...... 2. For control of porcine proliferative Feed as sole ration for 3 weeks or until signs 054771 enteropathies (ileitis) caused by Lawsonia of disease disappear.. intracellularis.. (iv) 200 ...... For reduction in the severity of swine Feed as sole ration for 3 weeks...... 054771 mycoplasmal pneumonia caused by Myco- 051311 plasma hyopneumoniae..

(3) Lincomycin may also be used in (x) Pyrantel as in § 558.485. combination with: (xi) Robenidine as in § 558.515. (i) Amprolium and ethopabate as in (xii) Salinomycin as in § 558.550. § 558.58. (xiii) Zoalene as in § 558.680. (ii) Clopidol as in § 558.175. (iii) Decoquinate as in § 558.195. [40 FR 13959, Mar. 27, 1975] (iv) Fenbendazole as in § 588.258. EDITORIAL NOTE: For FEDERAL REGISTER ci- (v) Halofuginone as in § 558.265. tations affecting § 558.325, see the List of CFR (vi) Ivermectin as in § 558.300. Sections Affected, which appears in the (vii) Lasalocid sodium as in § 558.311. Finding Aids section of the printed volume and at www.fdsys.gov. (viii) Monensin as in § 588.355. (ix) Nicarbazin alone and with narasin as in § 558.366.

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§ 558.340 Maduramicin. (i) For liquid feeds stored in recircu- (a) Approvals. Type A medicated arti- lating tank systems: Recirculate im- cles: 4.54 grams per pound to 054771 in mediately prior to use for no less than § 510.600(c) of this chapter. 10 minutes, moving not less than 1 per- (b) Tolerances. See § 556.375 of this cent of the tank contents per minute chapter. from the bottom of the tank to the top. (c) Conditions of use—(1) Amount. 4.54 Recirculate daily as described even to 5.45 grams per ton (5 to 6 parts per when not used. million) (1 to 1.2 pounds per ton). (ii) For liquid feeds stored in me- (i) Indications for use. For prevention chanical, air, or other agitation type of coccidiosis caused by Eimeria tank systems: Agitate immediately acervulina, E. tenella, E. brunetti, E. prior to use for not less than 10 min- maxima, E. necatrix, and E. mivati. utes, creating a turbulence at the bot- (ii) Limitations. For broiler chickens tom of the tank that is visible at the only. Feed continuously as sole ration. top. Agitate daily as described even Do not feed to laying hens. Withdraw 5 when not used. days before slaughter. (2) A physically stable melengestrol (2) [Reserved] acetate liquid Type B or C feed will not be subject to the requirements for mix- [54 FR 5229, Feb. 2, 1989, as amended at 54 FR ing directions prescribed in paragraph 26732, June 26, 1989; 54 FR 32635, Aug. 9, 1989; (d)(1) of this section provided it has a 54 FR 33885, Aug. 17, 1989; 55 FR 23, Jan. 2, pH of 4.0 to 8.0 and contains a sus- 1990; 55 FR 8460, Mar. 8, 1990; 55 FR 49616, Nov. 30, 1990; 59 FR 8134, Feb. 18, 1994; 61 FR pending agent(s) sufficient to maintain 18082, Apr. 24, 1996; 63 FR 27845, May 21, 1998; a viscosity of not less than 300 centi- 66 FR 46706, Sept. 7, 2001; 79 FR 13545, Mar. 11, poises per second for 3 months. 2014] (3) Combination Type B or C medicated feeds containing lasalocid must § 558.342 Melengestrol. be labeled in accordance with (a) Specifications. (1) Dry Type A § 558.311(d)(5) of this chapter. medicated articles containing 100 or 200 (4) Liquid combination Type B or C milligrams (mg) melengestrol acetate medicated feeds containing per pound. melengestrol acetate and lasalocid (2) Liquid Type A medicated article must be manufactured in accordance containing 500 mg melengestrol acetate with § 558.311(d) of this chapter. per pound. (5) Combination Type B or C medi- (b) Approvals. See sponsors in cated feeds containing monensin must § 510.600(c) of this chapter for use as in be labeled in accordance with paragraph (e) of this section. § 558.355(d) of this chapter. (1) No. 054771 for use of products de- (6) Liquid combination Type B or C scribed in paragraph (a) of this section. medicated feeds containing (2) No. 000986 for use of product de- melengestrol acetate and monensin scribed in paragraph (a)(2) of this sec- must be manufactured in accordance tion. with § 558.355(f)(3)(i) of this chapter. (c) Related tolerances. See § 556.380 of (7) Liquid combination Type B or C this chapter. medicated feeds containing (d) Special considerations. (1) Type B melengestrol acetate and tylosin must or C medicated feeds may be manufac- be manufactured in accordance with tured from melengestrol acetate liquid § 558.625(c) of this chapter. Type A articles or Type B or C medi- (8) Liquid melengestrol acetate may cated feeds which have a pH of 4.0 to 8.0 not be mixed with oxytetracycline in a and bear appropriate mixing directions common liquid feed supplement. as follows: (e) Conditions of use—(1) Cattle.

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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 000986 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- 000986 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.. (iii) 0.25 to 0.5 .... Lasalocid 100 to 360 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 000986 section.. (liquid or dry) containing 0.125 to 1.0 mg melengestrol acetate/lb to a feed containing 10 to 30 grams (g) of lasalocid per ton; or add at the rate of 0.5 to 2.0 lb/head/ day a medicated feed (liquid or dry) containing 0.125 to 1.0 mg melengestrol acetate plus 50 to 720 mg lasalocid/ lb to a ration of nonmedicated feed to provide 0.25 to 0.5 mg melengestrol acetate and 100 to 360 mg lasalocid/ head/day. . Lasalocid provided by No. 054771 in § 510.600(c) of this chapter.. (iv) 0.25 to 0.5 .... Lasalocid 100 to 360 Heifers fed in confinement for slaugh- To administer 0.25 to 0.5 mg 054771, plus tylosin 90.. ter: As in paragraph (e)(1)(i) of this melengestrol acetate plus 000986, section; and for reduced incidence 100 to 360 mg lasalocid plus 016592 of liver abscesses caused by 90 mg tylosin/head/day:. Fusobacterium necrophorum and 1. Add 0.5 to 2.0 lb/head/day of Actinomyces (Corynebacterium) a liquid or dry medicated pyogenes.. feed containing 0.125 to 1.0 mg melengestrol acetate/lb to a medicated feed containing 10 to 30 g lasalocid and 8 to 10 g tylosin per ton; or. 2. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate plus 50 to 720 mg lasalocid/lb to 4.5 to 18 lb of a dry medicated feed containing 10 to 40 g tylosin per ton; or. 3. Add 0.5 to 2.0 lb/head/day of a dry pelleted medicated feed containing 0.125 to 1.0 mg melengestrol acetate (from a dry Type A article), 50 to 720 mg lasalocid, and 45 to 180 mg tylosin/lb to a ration of nonmedicated feed.. Lasalocid provided by No. 054771, and tylosin provided by Nos. 000986 and 016592 in § 510.600(c) of this chapter. (v) [Reserved]. (vi)–(vii) [Re- served].

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

(viii) 0.25 to 0.5 .. Oxytetracycline 75 ... 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 section; and for reduction of liver (liquid or dry) containing condemnation due to liver ab- 0.125 to 1.0 mg melengestrol scesses.. acetate/lb per pound to a feed containing 6 to 10 g oxytetracycline per ton; or add at the rate of 0.5 to 2.0 lb/ head/day a dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate plus 37.5 to 150 mg oxytetracycline/lb to provide 0.25 to 0.5 mg melengestrol acetate and 75 mg oxytetracycline/ head/day.. Oxytetracycline as provided by No. 066104 in § 510.600(c) of this chapter.. (ix) 0.25 to 0.5 .... Tylosin 60 to 90 ...... Heifers fed in confinement for slaugh- To administer 0.25 to 0.5 mg 054771 ter: As in paragraph (e)(1)(i) of this melengestrol acetate with 60 000986 section; and for reduced incidence to 90 mg tylosin/head/day:. 016592 of liver abscesses caused by F. 1. Add 0.5 to 2.0 lb/head/day of necrophorum and Actinomyces a liquid or dry medicated (Corynebacterium) pyogenes.. feed containing 0.125 to 1.0 mg melengestrol acetate/lb to a medicated feed containing 8 to 10 g tylosin per ton; or. 2. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate/lb to 4.5 to 18 pounds of a dry medicated feed containing 10 to 40 g tylosin per ton; or. 3. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate (from a dry Type A article) plus 45 to 180 mg tylosin/lb to a ration of nonmedicated feed.. Tylosin provided by Nos. 000986 and 016592 in § 510.600(c) of this chapter. (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 000986 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. 000986 in § 510.600(c) of this chapter..

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

(xi) 0.25 to 0.5 .... Monensin 50 to 480, Heifers fed in confinement for slaugh- Feed continuously as sole ra- 054771 plus tylosin 60 to ter: As in paragraph (e)(1)(i) of this tion (liquid or dry) at a rate of 016592 90. section; for the prevention and con- 0.5 to 2.0 lb/head/day to pro- trol of coccidiosis due to Eimeria vide 0.25 to 0.5 mg/head/day bovis and E. zuernii; and for reduc- melengestrol acetate; 0.14 to tion of incidence of liver abscesses 0.42 mg monensin/lb body caused by Fusobacterium weight/day, depending on the necrophorum and Arcanobacterium severity of the coccidiosis pyogenes.. challenge, up to 480 mg/ head/day; and 60 to 90 mg/ head/day tylosin. The melengestrol acetate portion of this Type C medicated feed must be mixed into a complete feed containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin in the amount of complete feed consumed by an animal per day...... Monensin provided by No. 000986 and tylosin provided by Nos. 000986 and 016592 in § 510.600(c) of this chapter..

(2) Melengestrol may also be used of heat and continue as long as desired, with: but for not more than 12 months. (i) Ractopamine as in § 558.500 of this Mibolerone should not be used in chapter. bitches before first estrous period or in (ii) Zilpaterol as in § 558.665 of this purebred Bedlington terriers. It is not chapter. intended for animals being used pri- [42 FR 28535, June 3, 1977] marily for breeding purposes. Use orally in adult female dogs only. Federal EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 558.342, see the List of CFR law restricts this drug to use by or on Section Affected, which appears in the Find- the order of a licensed veterinarian. ing Aids section of the printed volume and at www.fdsys.gov. [47 FR 6617, Feb. 16, 1982, as amended at 79 FR 13545, Mar. 11, 2014] § 558.348 Mibolerone. § 558.355 Monensin. (a) Approvals. To No. 054771in § 510.600(c) of this chapter for a canned (a) Specifications. Type A medicated dog food, each 61⁄2 ounce can containing articles containing monensin, USP. 30 or 60 micrograms of mibolerone. (b) Approvals. Approvals for Type A (b) Conditions of use—(1) Amount. 30 medicated articles containing the spec- micrograms for animals weighing up to ified levels of monensin activity grant- 25 pounds; 60 micrograms for animals ed to firms identified by sponsor num- weighing 26 to 50 pounds; 120 bers in § 510.600(c) of this chapter for micrograms for animals weighing 51 to the conditions of use indicated in para- 100 pounds; 180 micrograms for animals graph (f) of this section are as follows: weighing over 100 pounds, or German (1) To No. 000986: 36.3 (for export Shepherds or German Shepherd mix only), 44, 45, 60, or 90.7 grams per pound weighing 30 to 80 pounds. for use as in paragraphs (f)(1)(i) and (2) Indications for use. For the preven- (f)(4) of this section. tion of estrus (heat) in adult female (2) To 000986: 110 grams per lb., para- dogs not intended primarily for breeding purposes. graphs (f)(1) (i), (iii), (iv), (v), (ix), and (3) Limitations. Administer daily at (x). least 30 days before expected initiation (3) [Reserved]

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(4) To No. 000986: 45, 60, or 90.7 grams immediately rinse thoroughly with per pound for use as in paragraph (f)(2) water. of this section. (6) All formulations containing (5) To 066104: 45 and 60 grams per monensin shall bear the following cau- pound, as monensin sodium provided by tion statement: Do not allow horses or No. 000986, paragraphs (f)(1)(xiii), (xx), other equines access to feed containing and (xxi) of this section. monensin. Ingestion of monensin by (6) To No. 000986: 45, 60, or 90.7 grams horses has been fatal. per pound for use as in paragraph (f)(5) (7) Type A medicated articles con- of this section. taining monensin intended for use in (7) To 000986: 20, 30, 45, 60, 80, and 90.7 cattle and goats shall bear, in addition grams per pound, as monensin sodium, to the caution statement in paragraph paragraph (f)(3) of this section. (d)(6) of this section, the following (8) To 054771: 45 and 60 grams per statements: pound, as monensin sodium provided by (i) Monensin medicated cattle and No. 000986, paragraph (f)(1)(xiv) of this goat feeds are safe for use in cattle and section. goats only. Consumption by unap- (9) To 054771: 45 and 60 grams per proved species may result in toxic re- pound, as monensin sodium provided by actions. No. 000986, paragraphs (f)(1)(xv) and (ii) Feeding undiluted or mixing er- (xvi) of this section. rors resulting in high concentrations of (10) To 016592: 45 and 60 grams per monensin has been fatal to cattle and pound, as monensin sodium, paragraph could be fatal to goats. (f)(1)(xvii) of this section. (iii) Must be thoroughly mixed in feeds before use. (11) To 054771: 45 and 60 grams per (iv) Do not feed undiluted. pound, as monensin sodium provided by (v) Do not exceed the levels of No. 000986, paragraphs (f)(1)(xiv), monensin recommended in the feeding (xviii), (xix), (xxiii), (xxiv), (xxv), directions, as reduced average daily (xxvi), and (xxvii) of this section. gains may result. (12) To 066104: 45 and 60 grams per (vi) Do not feed to lactating goats. pound, as monensin sodium provided by (vii) If feed refusals containing No. 000986, paragraph (f)(1)(xxii) of this monensin are fed to other groups of section. cattle, the concentration of monensin (13) To No. 012286: 60 and 80 grams per in the refusals and amount of refusals pound, paragraph (f)(3)(v) of this sec- fed should be taken into consideration tion. to prevent monensin overdosing (see (14) To 000986: 60, 80, and 90.7 grams paragraphs (d)(10)(i) and (d)(10)(ii) of per pound, as monensin sodium, para- this section). graph (f)(6) of this section. (viii) A withdrawal period has not (c) [Reserved] been established for this product in (d) Special considerations. (1) Type C pre-ruminating calves. Do not use in chicken feed containing monensin as calves to be processed for veal. the mycelial cake shall bear an expira- (ix) You may notice the following: tion date of 90 days after its date of Reduced voluntary feed intake in dairy manufacture. cows fed monensin. This reduction in- (2)–(3) [Reserved] creases with higher doses of monensin (4) Liquid Type B feeds shall bear an fed. Rule out monensin as the cause of expiration date of 8 weeks after its reduced feed intake before attributing date of manufacture. to other causes such as illness, feed (5) All Type A medicated articles management, or the environment. Re- containing monensin shall bear the fol- duced milk fat percentage in dairy lowing warning statement: When mix- cows fed monensin. This reduction in- ing and handling monensin Type A creases with higher doses of monensin 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

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calving intervals in dairy cows fed (v) Turkeys: See paragraphs (d)(8)(i), monensin. Have a comprehensive and (d)(8)(ii), (d)(8)(iii), and (d)(8)(vii) of ongoing nutritional, reproductive, and this section. herd health program in place when (vi) Quail: See paragraphs (d)(8)(i), feeding monensin to dairy cows. (d)(8)(ii), and (d)(8)(iii) of this section. (x) Inadequate mixing (recirculation (10) Type C feeds containing or agitation) of monensin liquid Type B monensin shall bear the statements or Type C medicated feeds has resulted specified in the following paragraphs of in increased monensin concentration this section when intended for use in: which has been fatal to cattle and (i) Cattle (as described in paragraphs could be fatal to goats. (f)(3)(i) through (f)(3)(xii) of this section): (8) Type A medicated articles con- See paragraphs (d)(6), (d)(7)(i), (d)(7)(v), taining monensin intended for use in (d)(7)(vii), and (d)(7)(viii) of this sec- chickens, turkeys, and quail shall bear tion. Paragraph (d)(7)(vii) of this sec- the following statements: tion does not apply to free-choice Type (i) Do not allow horses, other C medicated feeds as defined in § 510.455 equines, mature turkeys, or guinea of this chapter. fowl access to feed containing (ii) Dairy cows (as described in para- monensin. Ingestion of monensin by graphs (f)(3)(xiii) and (f)(3)(xiv) of this horses and guinea fowl has been fatal. section): See paragraphs (d)(6), (d)(7)(i), (ii) Must be thoroughly mixed in (d)(7)(vii), (d)(7)(viii), and (d)(7)(ix) of feeds before use. this section. Paragraph (d)(7)(vii) of (iii) Do not feed undiluted. this section does not apply to free- (iv) Do not feed to laying chickens. choice Type C medicated feeds as de- (v) Do not feed to chickens over 16 fined in § 510.455 of this chapter. weeks of age. (iii) Goats: See paragraphs (d)(6), (vi) For replacement chickens in- (d)(7)(i), (d)(7)(v), and (d)(7)(vi) of this tended for use as cage layers only. section. (vii) Some strains of turkey coccidia (iv) Chickens: See paragraphs (d)(8)(i), may be monensin tolerant or resistant. (d)(8)(iv), (d)(8)(v), (d)(8)(vi), and Monensin may interfere with develop- (d)(8)(viii) of this section. ment of immunity to turkey coccidi- (v) Turkeys: See paragraphs (d)(8)(i) osis. and (d)(8)(vii) of this section. (viii) In the absence of coccidiosis in (vi) Quail: See paragraph (d)(8)(i) of broiler chickens the use of monensin this section. with no withdrawal period may limit (11) Type B and Type C liquid feeds feed intake resulting in reduced weight requiring recirculation or agitation gain. that contain monensin and are in- (9) Type B feeds containing monensin tended for use in cattle (including shall bear the statements specified in dairy cows) and goats shall bear the the following paragraphs of this sec- caution statement specified in para- tion when intended for use in: graph (d)(7)(x) of this section. (i) Cattle (as described in paragraphs (12) Mixing directions for liquid feeds (f)(3)(i) through (f)(3)(xii) of this section): requiring recirculation or agitation: See paragraphs (d)(6), (d)(7)(i) through (i) For liquid feeds stored in recircu- (d)(7)(v), (d)(7)(vii), and (d)(7)(viii) of lating tank systems: Recirculate im- this section. mediately prior to use for not less than (ii) Dairy cows (as described in para- 10 minutes, moving not less than 1 per- graphs (f)(3)(xiii) and (f)(3)(xiv) of this cent of the tank contents per minute section): See paragraphs (d)(6), (d)(7)(i) from the bottom of the tank to the top. through (d)(7)(iv), (d)(7)(vii), (d)(7)(viii), Recirculate daily as described even and (d)(7)(ix) of this section. when not used. (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

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top. Agitate daily as described even necatrix, E. tenella, E. acervulina, E. when not used. brunetti, E. mivati, and E. maxima. (e) Related tolerances. See § 556.420 of (b) Limitations. Do not feed to laying this chapter. chickens; feed continuously as sole ra- (f) Conditions of use. It is used as fol- tion; in the absence of coccidiosis, the lows: use of monensin with no withdrawal (1) Broiler chickens—(i) Amount per period may limit feed intake resulting ton. Monensin, 90–110 grams. in reduced weight gain; as zinc baci- (a) Indications for use. As an aid in tracin provided by No. 054771 in the prevention of coccidiosis caused by § 510.600(c) of this chapter; as monensin E. necatrix, E. tenella, E. acervulina, E. sodium. brunetti, E. mivati, and E. maxima. (vi) Amount per ton. Monensin, 90 to (b) Limitations. Feed continuously as 110 grams; plus bambermycins, 1 to 2 the sole ration. In the absence of coc- grams. cidiosis, the use of monensin with no (a) Indications for use. For increased withdrawal period may limit feed in- rate of weight gain and improved feed take resulting in reduced weight gain. efficiency; and as an aid in the preven- Do not feed to laying chickens. tion of coccidiosis caused by E. necatrix, E. tenella,E. acervulina, E. (ii) [Reserved] brunetti, E. mivati, and E. maxima. (iii) Amount per ton. Monensin, 90–110 (b) Limitations. Feed continuously as grams plus bacitracin, 5–25 grams. sole ration; do not feed to laying chick- (a) Indications for use. For increased ens. Bambermycins provided by No. rate of weight gain and improved feed 016592 in § 510.600(c) of this chapter. efficiency; as an aid in the prevention (vii) [Reserved] of coccidiosis caused by E. necatrix, E. (viii) Amount per ton. Monensin, 90 to tenella, E. acervulina, E. brunetti, E. 110 grams plus oxytetracycline, 200 mivati, and E. maxima. grams. (b) Limitations. Do not feed to laying (a) Indications for use. As an aid in chickens; feed continuously as sole ra- the prevention of coccidiosis caused by tion; in the absence of coccidiosis, the Eimeria necatrix, E. tenella, E. use of monensin with no withdrawal acervulina, E. brunetti, E. mivati, and E. period may limit feed intake resulting maxima; and for the control of com- in reduced weight gain; as bacitracin plicated chronic respiratory disease methylene disalicylate provided by No. (CRD or air-sac infection) caused by 054771 in § 510.600(c) of this chapter; as Mycoplasma gallisepticum and Esch- monensin sodium. erichia coli. (iv) Amount per ton. Monensin, 90–110 (b) Limitations. In the absence of coc- grams plus bacitracin, 10 grams. cidiosis, the use of monensin with no (a) Indications for use. For increased withdrawal period may limit feed in- rate of weight gain and improved feed take resulting in reduced weight gain; efficiency; as an aid in the prevention do not feed to laying chickens; feed of coccidiosis caused by E. necatrix, E. continuously as sole ration; as tenella, E. acervulina, E. brunetti, E. monensin sodium. mivati, and E. maxima. (ix) Amount per ton. Monensin, 90–110 (b) Limitations. Do not feed to laying grams plus lincomycin, 2 grams. chickens; feed continuously as sole ra- (a) Indications for use. For increase in tion; in the absence of coccidiosis, the rate of weight gain and improved feed use of monensin with no withdrawal efficiency; as an aid in the prevention period may limit feed intake resulting of coccidiosis caused by E. necatrix, E. in reduced weight gain; as zinc baci- tenella, E. acervulina, E. brunetti, E. tracin provided by No. 054771 in mivati, and E. maxima. § 510.600(c) of this chapter; as monensin (b) Limitations. Do not feed to laying sodium. chickens; to be fed as a sole ration; in (v) Amount per ton. Monensin, 90–110 the absence of coccidiosis, the use of grams plus bacitracin, 10–30 grams. monensin with no withdrawal period (a) Indications for use. For improved may limit feed intake resulting in re- feed efficiency; as an aid in the preven- duced weight gain; as monensin so- tion of coccidiosis caused by E. dium.

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(x)–(xii) [Reserved] maxima; as an aid in the reduction of (xiii) Amount per ton. Monensin, 90 to mortality due to air-sacculities (air- 110 grams, plus 5 grams virginiamycin. sac infection) caused by Escherichia coli (a) Indications for use. As an aid in sensitive to oxytetracycline. the prevention of coccidiosis caused by (b) Limitations. Feed for 5 days as sole E. necatrix, E. tenella, E. acervulina, E. ration. Do not feed to laying chickens. brunetti, E. maxima, and E. mivati; for Withdraw 24 hours before slaughter. As increased rate of weight gain and im- monensin sodium provided by No. proved feed efficiency. 000986 in § 510.600(c) of this chapter. As (b) Limitations. Do not feed to laying mono-alkyl (C8-C18) chickens; feed continuously as sole ra- trimethylammonium oxytetracycline tion; as monensin sodium provided by provided by No. 066104 in § 510.600(c) of No. 000986 in § 510.600 of this chapter; this chapter. virginiamycin provided by No. 066104 in (xxiii) [Reserved] § 510.600 of this chapter. (xxiv) Amount per ton. Monensin, 90 to (xiv) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin methylene 110 grams, plus 500 grams chlortetra- disalicylate, 4 to 50 grams. cycline. (xxv) Amount per ton. Monensin, 90 to (a) Indications for use. As an aid in 110 grams plus bacitracin, 4 to 50 the reduction of mortality due to Esch- grams. erichia coli infections susceptible to (a) Indications for use. For increased such treatment. As an aid in the pre- rate of weight gain and improved feed vention of coccidiosis caused by Eimeria efficiency; as an aid in the prevention necatrix, E. tenella, E. acervulina, E. of coccidiosis caused by Eimeria brunetti, E. mivati, and E. maxima. necatrix, E. tenella, E. acervulina, E. (b) Limitations. Do not feed to laying brunetti, E. mivati, and E. maxima. chickens; feed for 5 days as the sole ra- (b) Limitations. Do not feed to laying tion; withdraw 24 hours before slaugh- chickens; feed continuously as sole ra- ter; in the absence of coccidiosis, the tion; in the absence of coccidiosis, the use of monensin with no withdrawal use of monensin with no withdrawal period may limit feed intake resulting period may limit feed intake resulting in reduced weight gain; not to be fed in reduced weight gain; as bacitracin continuously for more than 5 days; as zinc provided by No. 054771 in monensin sodium; as chlortetracycline § 510.600(c) of this chapter, as monensin hydrochloride provided by Nos. 054771 sodium. and 048164 in § 510.600(c) of this chapter. (xxvi)–(xxvii) [Reserved] (xv)–(xx) [Reserved] (xxviii) Amount per ton. Monensin, 90 (xxi) Amount per ton. Monensin, 90 to to 110 grams, plus tylosin phosphate, 4 110 grams, plus virginiamycin, 5 to 15 to 50 grams. grams. (a) Indications for use. As an aid in (a) Indications for use. For increase in the prevention of coccidiosis caused by rate of weight gain; as an aid in the Eimeria necatrix, E. tenella, E. prevention of coccidiosis caused by acervulina, E. brunetti, E. mivati, and E. Eimeria necatrix, E. tenella, E. maxima, for increased rate of weight acervulina, E. maxima, E. brunetti, and gain, and improved feed efficiency. E. mivati. (b) Limitations. Feed continuously as (b) Limitations. Do not feed to laying sole ration. In the absence of coccidi- chickens; feed continuously as sole ra- osis, the use of monensin with no with- tion; as monensin sodium provided by drawal period may limit feed intake re- No. 000986 in § 510.600 of this chapter; sulting in reduced weight gain. Do not virginiamycin provided by No. 066104 in feed to laying chickens. As monensin § 510.600 of this chapter. sodium and tylosin phosphate provided (xxii) Amount per ton. Monensin, 90 to by No. 000986 in § 510.600(c) of this chap- 110 grams plus oxytetracycline, 500 ter. grams. (xxix) Amount per ton. Monensin, 90 to (a) Indications for use. As an aid in 110 grams; plus bacitracin methylene the prevention of coccidiosis caused by disalicylate, 50 grams. Eimeria necatrix, E. tenella, E. (a) Indications for use. As an aid in acervulina, E. brunetti, E. Mivati, and E. the prevention of coccidiosis caused by

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E. necatrix, E. tenella, E. acervulina, E. (a) Indications for use. For prevention brunetti, E. mivati, and E. maxima; and of coccidiosis caused by Eimeria as an aid in the prevention of necrotic adenoeides, E. meleagrimitis, and E. enteritis caused or complicated by gallopavonis, for increased rate of Clostridium spp. or other organisms sus- weight gain, and for improved feed effi- ceptible to bacitracin. ciency. (b) Limitations. Feed continuously as (b) Limitations. For growing turkeys sole ration. Do not feed to chickens only; as monensin sodium; feed con- over 16 weeks of age. Do not feed to tinuously as sole ration. Do not allow laying chickens. As monensin sodium horses, other equines, mature turkeys provided by 000986; bacitracin meth- or guinea fowl access to feed con- ylene disalicylate as provided by 054771 taining monensin. Ingestion of in § 510.600(c) of this chapter. monensin by horses and guinea fowl (xxx) Amount per ton. Monensin, 90 to has been fatal. Some strains of turkey 110 grams; plus bacitracin methylene coccidia may be monensin tolerant or disalicylate, 100 to 200 grams. resistant. Monensin may interfere with (a) Indications for use. As an aid in development of immunity to turkey the prevention of coccidiosis caused by coccidiosis. Bacitracin methylene disa- E. necatrix, E. tenella, E. acervulina, E. licylate as provided by No. 054771 in brunetti, E. mivati, and E. maxima; and § 510.600(c) of this chapter. as an aid in the control of necrotic en- (iii) Amount per ton. Monensin, 54 to teritis caused or complicated by Clos- 90 grams, and bacitracin methylene di- tridium spp. or other organisms suscep- salicylate, 200 grams. tible to bacitracin. (a) Indications for use. For the preven- (b) Limitations. Feed continuously as tion of coccidiosis caused by Eimeria sole ration. Do not feed to chickens adenoides, E. meleagrimitis, and E. over 16 weeks of age. Do not feed to gallopavonis, and as an aid in the con- laying chickens. To control necrotic trol of transmissible enteritis com- enteritis, start medication at first clin- plicated by organisms susceptible to ical signs of disease; vary dosage based bacitracin methylene disalicylate. on the severity of infection; administer (b) Limitations. For growing turkeys continuously for 5 to 7 days or as long only; as monensin sodium; feed con- as clinical signs persist, then reduce tinuously as sole ration. Do not allow bacitracin to prevention level (50 horses, other equines, mature turkeys grams per ton). As monensin sodium or guinea fowl access to feed con- provided by 000986; bacitracin meth- taining monensin. Ingestion of ylene disalicylate as provided by 054771 monensin by horses and guinea fowl in § 510.600(c) of this chapter. has been fatal. Some strains of turkey (2) Turkeys—(i) Amount per ton. coccidia may be monensin tolerant or Monensin, 54 to 90 grams. resistant. Monensin may interfere with (a) Indications for use. For the preven- development of immunity to turkey tion of coccidiosis in turkeys caused by coccidiosis. Bacitracin methylene disa- E. adenoeides, E. meleagrimitis, and E. licylate as provided by No. 054771 in gallopavonis. § 510.600(c) of this chapter. (b) Limitations. For growing turkeys (iv) Amount per ton. Monensin, 54 to only; as monensin sodium; feed con- 90 grams, with virginiamycin, 10 to 20 tinuously as sole ration. Do not allow grams. horses, other equines, mature turkeys, (a) Indications for use. For the preven- or guinea fowl access to feed con- tion of coccidiosis caused by Eimeria taining monensin. Ingestion of adenoeides, E. meleagrimitis, and E. monensin by horses and guinea fowl gallopavonis, and for increased rate of has been fatal. Some strains of turkey weight gain and improved feed effi- coccidia may be monensin tolerant or ciency in growing turkeys. resistant. Monensin may interfere with (b) Limitations. For growing turkeys development of immunity to turkey only. Feed continuously as sole ration. coccidiosis. Do not allow horses, other equines, ma- (ii) Amount per ton. Monensin, 54 to 90 ture turkeys, or guinea fowl access to grams, and bacitracin methylene disa- feed containing monensin. Ingestion of licylate, 4 to 50 grams. monensin by horses, mature turkeys,

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and guinea fowl has been fatal. Some follows: Inadequate mixing, (recircula- strains of turkey coccidia may be tion or agitation), of liquid feeds has monensin tolerant or resistant. resulted in increased monensin con- Monensin may interfere with develop- centration which has been fatal to cat- ment of immunity to turkey coccidi- tle. osis. Virginiamycin as provided by No. (2) An approved physically stable 066104 in § 510.600(c) of this chapter. monensin liquid feed will not be sub- (v) Amount per ton. Monensin, 54 to 90 ject to the requirements for mixing di- grams, plus bambermycins, 1 to 2 rections defined in paragraph (d)(12) of grams. this section. A manufacturer may se- (a) Indications for use. For the preven- cure approval of a physically stable liq- tion of coccidiosis in turkeys caused by uid feed by: E. adenoeides, E. meleagrimitis, and E. (i) Either filing an NADA for the gallopavonis, and for improved feed effi- product or by establishing a master file ciency in growing turkeys. containing data to support the sta- (b) Limitations. For growing turkeys bility of its product; only. Feed continuously as sole ration. (ii) Authorizing the agency to ref- Some strains of turkey coccidia may be erence and rely upon the data in the monensin tolerant or resistant. master file to support approval of a Monensin may interfere with develop- supplemental NADA to establish phys- ment of immunity to turkey coccidi- ical stability; and osis. Bambermycins as provided by No. (iii) Requesting No. 000986 in 016592 in § 510.600(c) of this chapter. § 510.600(c) of this chapter to file a sup- (vi) Amount per ton. Monensin, 54 to plemental NADA to provide for the use 90 grams, plus bambermycins, 2 grams. of its monensin Type A article in the (a) Indications for use. For the preven- manufacture of the liquid feed specified tion of coccidiosis in turkeys caused by in the appropriate master file. If the E. adenoeides, E. meleagrimitis, and E. data demonstrate the stability of the gallopavonis, and for increased rate of liquid feed described in the master file, weight gain and improved feed effi- the agency will approve the supple- ciency in growing turkeys. mental NADA. The approval will pro- (b) Limitations. For growing turkeys vide a basis for the individual liquid only. Feed continuously as sole ration. feed manufacturer to manufacture the Some strains of turkey coccidia may be liquid medicated feed under a medi- monensin tolerant or resistant. cated feed mill license described in the Monensin may interfere with develop- master file. A manufacturer who seeks ment of immunity to turkey coccidi- to market a physically unstable osis. Bambermycins as provided by No. monensin liquid feed with mixing di- 016592 in § 510.600(c) of this chapter. rections different from the standard es- (3) Cattle—(i) Amount per ton. tablished in paragraph (d)(12) of this Monensin, 5–40 grams. section may also follow this procedure. (a) Indications for use. Improved feed (ii) Amount per ton. Monensin, 5 to 40 efficiency. grams; plus tylosin, 8 to 10 grams. (b) Limitations. (1) Feed only to cattle (a) Indications for use. Cattle fed in being fed in confinement for slaughter. confinement for slaughter: For im- Feed continuously in complete feed at proved feed efficiency; and reduction of a rate of 50 to 480 milligrams of incidence of liver abscesses caused by monensin per head per day. No addi- Fusobacterium necrophorum and tional improvement in feed efficiency Arcanobacterium (Actinomyces) pyogenes. has been shown from feeding monensin (b) Limitations. Feed only to cattle at levels greater than 30 grams per ton being fed in confinement for slaughter. (360 milligrams per head per day). Com- Feed continuously as sole ration at the plete feeds may be manufactured from rate of 50 to 480 milligrams of monensin liquid Type B feeds. The liq- monensin and 60 to 90 milligrams of uid Type B feeds have a pH of 4.3 to 7.1 tylosin per head per day. Combination and their labels must bear appropriate drug liquid Type B medicated feeds mixing directions as defined in para- may be used to manufacture dry Type graph (d)(12) of this section. The liquid C medicated feeds and shall conform to feed must bear caution statement as mixing instructions as in 558.625(c) of

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this chapter. Tylosin provided by Nos. tiveness in cull cows and bulls has not 000986 and 016592 in § 510.600(c) of this been established. See paragraph (d) of chapter. this section for other required label (iii) Amount per ton. Monensin, 15 to warnings. 400 grams. (v) [Reserved] (a) Indications for use. Growing cattle (vi) Amount per ton. Monensin, 25 to on pasture or in dry lot (stocker and 400 grams. feeder cattle and dairy and beef re- (a) Indications for use. For improved placement heifers): For increased rate feed efficiency; for prevention and con- of weight gain; for prevention and control of coccidiosis due to E. bovis and E. trol of coccidiosis due to Eimeria bovis zuernii. and E. zuernii. (b) Limitations. Feed to mature repro- (b) Limitations. For increased rate of ducing beef cows. Feed as supplemental weight gain, feed at a rate of 50 to 200 feed, either hand-fed in a minimum of milligrams monensin per head per day 1 pound of feed or mixed in a total rain not less than 1 pound of feed or, tion. For improved feed efficiency, feed after the 5th day, feed at a rate of 400 continuously at a rate of 50 to 200 mil- milligrams per head per day every ligrams monensin per head per day. other day in not less than 2 pounds of For prevention and control of coccidi- feed. For prevention and control of coc- osis, feed at a rate of 0.14 to 0.42 milli- cidiosis, feed at a rate of 0.14 to 0.42 gram per pound of body weight per day, milligram per pound of body weight per depending upon severity of challenge, day, depending on severity of chal- up to a maximum of 200 milligrams per lenge, up to 200 milligrams per head per head per day. During first 5 days of day. During first 5 days of feeding, cat- feeding, cattle should receive no more tle should receive no more than 100 than 100 milligrams per head per day. milligrams per day in not less than 1 pound of feed. (vii) Amount per ton. Monensin, 10 to (iv) Amount. Monensin at concentra- 40 grams. tions in free-choice Type C medicated (a) Indications for use. For prevention feeds to provide 50 to 200 mg per head and control of coccidiosis due to E. per day. bovis and E. zuernii. (a) Indications for use. Growing cattle (b) Limitations. For cattle fed in con- on pasture or in dry lot (stocker and finement for slaughter, feed at a rate of feeder cattle and dairy and beef re- 0.14 to 0.42 milligram per pound of body placement heifers): For increased rate weight per day, depending upon the se- of weight gain; for prevention and con- verity of challenge, up to maximum of trol of coccidiosis due to Eimeria bovis 480 milligrams per head per day. and E. zuernii. (ix) [Reserved] (b) Limitations. During the first 5 days (x) Amount per ton. 1,620 grams of feeding, cattle should receive no monensin, USP. more than 100 milligrams per day. Do (a) Indications for use. Growing cattle not feed additional salt or minerals. Do on pasture or in dry lot (stocker and not mix with grain or other feeds. feeder cattle and dairy and beef re- Monensin is toxic to cattle when con- placement heifers): For increased rate sumed at higher than approved levels. of weight gain; for prevention and con- Stressed and/or feed- and/or water-de- trol of coccidiosis due to Eimeria bovis prived cattle should be adapted to the and E. zuernii. pasture and to unmedicated supple- (b) Specifications. Use as free-choice ment before using the monensin medi- Type C medicated feed formulated as cated supplement. The product’s effec- 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 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

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International feed Ingredient Percent No.

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 (A) Indications for use. For increased 200 milligrams per head per day. Dur- milk production efficiency (production ing the first 5 days of feeding, cattle of marketable solids-corrected milk should receive no more than 100 milli- per unit of feed intake) in dairy cows. grams per day. Do not feed additional (B) Limitations. Feed continuously to salt or minerals. Do not mix with grain dry and lactating dairy cows in a total or other feeds. Monensin is toxic to mixed ration (‘‘complete feed’’). See cattle when consumed at higher than special labeling considerations in para- approved levels. Stressed and/or feed- graph (d) of this section. and/or water-deprived cattle should be (xiv) Amount per ton. Monensin, 11 to adapted to the pasture and to 400 grams. unmedicated mineral supplement be- (A) Indications for use. For increased fore using the monensin mineral sup- milk production efficiency (production plement. The product’s effectiveness in of marketable solids-corrected milk cull cows and bulls has not been estab- per unit of feed intake) in dairy cows. lished. (B) Limitations. Feed continuously to (xi) Amount per ton. Monensin, 10 to dry and lactating dairy cows in a com- 200 grams. ponent feeding system (including top (a) Indications for use. For prevention dress). The Type C medicated feed must and control of coccidiosis due to E. be fed in a minimum of 1 lb of feed to bovis and E. zuernii. provide 185 to 660 mg/head/day (b) Limitations. For calves excluding monensin to lactating cows or 115 to veal calves. Feed at a rate of 0.14 to 1.0 410 mg/head/day monensin to dry cows. milligram monensin per pound of body See special labeling considerations in weight per day, depending upon the se- paragraph (d) of this section. verity of challenge, up to maximum of 200 milligrams per head per day. (4) Replacement chickens intended for use as cage layers—(i) Amount per ton. (xii) Amount per ton. Monensin, 10 to Monensin, 90 to 110 grams. 40 grams; plus tylosin, 8 to 10 grams. (i)(a) Indications for use. As an aid in (a) Indications for use. Cattle fed in confinement for slaughter: For preven- the prevention of coccidiosis caused by tion and control of coccidiosis due to E. E. necatrix, E. tenella, E. acervulina, E. bovis and E. zuernii; and reduction of in- brunetti, E. mivati, and E. maxima. cidence of liver abscesses caused by (ii) Amount per ton. Monensin, 90 to Fusobacterium necrophorum and 110 grams; plus bacitracin methylene Arcanobacterium (Actinomyces) pyogenes. disalicylate, 4 to 50 grams. (b) Limitations. Feed only to cattle (a) Indications for use. As an aid in being fed in confinement for slaughter. the prevention of coccidiosis caused by For prevention and control of coccidi- E. necatrix, E. tenella, E. acervulina, E. osis, feed at a rate of 0.14 to 0.42 milli- brunetti, E. mivati, and E. maxima; for grams monensin per pound of body increased rate of weight gain, and im- weight per day, depending upon the se- proved feed efficiency. verity of challenge, up to maximum of (b) Limitations. Feed continuously as 480 milligrams per head per day; and 60 sole ration. Do not feed to chickens to 90 milligrams of tylosin per head per over 16 weeks of age. Do not feed to day. Tylosin provided by Nos. 000986 laying chickens. As monensin sodium and 016592 in § 510.600(c) of this chapter. provided by 000986; bacitracin meth- (xiii) Amount per ton. Monensin, 11 to ylene disalicylate as provided by 054771 22 grams. in § 510.600(c) of this chapter.

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(iii) Amount per ton. Monensin, 90 to (6) Goats—(i) Amount per ton. 110 grams; plus bacitracin methylene Monensin, 20 grams. disalicylate, 50 grams. (a) Indications for use. For the preven- (a) Indications for use. As an aid in tion of coccidiosis caused by Eimeria the prevention of coccidiosis caused by crandallis, E. christenseni, and E. E. necatrix, E. tenella, E. acervulina, E. ninakohlyakimovae. brunetti, E. mivati, and E. maxima; and (b) Limitations. (1) Feed continuously. as an aid in the prevention of necrotic Feed only to goats being fed in confine- enteritis caused or complicated by ment. Do not feed to lactating goats. Clostridium spp. or other organisms sus- Type C feeds may be manufactured ceptible to bacitracin. from monensin liquid Type B feeds. (b) Limitations. Feed continuously as The liquid Type B feeds have a pH of 4.3 sole ration. Do not feed to chickens to 7.1 and their labels must bear appro- over 16 weeks of age. Do not feed to priate mixing directions, as defined in laying chickens. As monensin sodium paragraph (d)(12) of this section. See provided by 000986; bacitracin meth- special labeling considerations in para- ylene disalicylate as provided by 054771 graph (d) of this section. in § 510.600(c) of this chapter. (2) An approved physically stable (iv) Limitations. Do not feed to laying monensin liquid feed will not be sub- chickens; feed continuously as sole ra- ject to the requirements for mixing dition; as monensin sodium; do not feed rections defined in paragraph (d)12) of to chickens over 16 weeks of age. this section. A manufacturer may se- (v) Amount per ton. Monensin, 90 to cure approval of a physically stable liq- 110 grams; plus bacitracin methylene uid feed by: disalicylate, 100 to 200 grams. ( ) Either filing an NADA for the (a) Indications for use. As an aid in i the prevention of coccidiosis caused by product or by establishing a master file containing data to support the sta- E. necatrix, E. tenella, E. acervulina, E. bility of its product; brunetti, E. mivati, and E. maxima; and as an aid in the control of necrotic en- (ii) Authorizing the agency to ref- teritis caused or complicated by Clos- erence and rely upon the data in the tridium spp. or other organisms suscep- master file to support approval of a tible to bacitracin. supplemental NADA to establish phys- (b) Limitations. Feed continuously as ical stability; and sole ration. Do not feed to chickens (iii) Requesting No. 000986 in over 16 weeks of age. Do not feed to § 510.600(c) of this chapter to file a sup- laying chickens. To control necrotic plemental NADA to provide for the use enteritis, start medication at first clin- of its monensin Type A article in the ical signs of disease; vary dosage based manufacture of the liquid feed specified on the severity of infection; administer in the appropriate master file. If the continuously for 5 to 7 days or as long data demonstrate the stability of the as clinical signs persist, then reduce liquid feed described in the master file, bacitracin to prevention level (50 the agency will approve the supple- grams per ton). As monensin sodium mental NADA. The approval will pro- provided by 000986; bacitracin meth- vide a basis for the individual liquid ylene disalicylate as provided by 054771 feed manufacturer to manufacture the in § 510.600(c) of this chapter. liquid medicated feed under a medi- (vi)–(vii) [Reserved] cated feed mill license described in the (5) Bobwhite quail—(i) Amount per ton. master file. A manufacturer who seeks Monensin, 73 grams. to market a physically unstable (ii) Indications for use. For the pre- monensin liquid feed with mixing di- vention of coccidiosis in growing bob- rections different from the standard es- white quail caused by Eimeria dispersa tablished in paragraph (d)(12) of this and E. Lettyae. section may also follow this procedure. (iii) Limitations. Feed continuously as (ii) [Reserved] the sole ration; do not allow horses, (7) Free-choice feeds—(i) Amount. 150 other equines, mature turkeys, or guin- milligrams per pound of protein-min- ea fowl access to feed containing eral block (0.033 percent). monensin. (a) [Reserved]

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(b) Conditions of use—(1) Indications (iv) Amount. 400 milligrams per pound for use. For increased rate of weight of block (0.088 percent). gain; and for prevention and control of (a) Sponsor. See No. 051267 in coccidiosis caused by Eimeria bovis and § 510.600(c) of this chapter. E. zuernii in pasture cattle (slaughter, (b) Conditions of use—(1) Indications stocker, feeder, and dairy and beef re- for use. For increased rate of weight placement heifers) which may require gain in pasture cattle (slaughter, supplemental feed. stocker, feeder, and dairy and beef re- (2) Limitations. Provide 50 to 200 milli- placement heifers). grams of monensin (0.34 to 1.33 pounds (2) Limitations. Provide 50 to 200 milli- of block) per head per day, at least 1 grams of monensin (2 to 8 ounces of block per 10 to 12 head of cattle. block) per head per day, at least 1 Roughage must be available at all block per 5 head of cattle. Feed blocks times. Do not allow animals access to continuously. Do not feed salt or min- other protein blocks, salt or mineral, eral supplements in addition to the while being fed this product. The effec- blocks. Ingestion by cattle of monensin tiveness of this block in cull cows and at levels of 600 milligrams per head per bulls has not been established. See day and higher has been fatal. The ef- paragraph (d)(10)(i) of this section. fectiveness of this block in cull cows (ii) Amount. 400 milligrams per pound and bulls has not been established. See of protein-mineral block (0.088 per- paragraph (d)(10)(i) of this section. cent). (8) Monensin may also be used in (a) Sponsor. See No. 067949 in combination with: § 510.600(c) of this chapter. (i) Decoquinate alone or with tylosin (b) Conditions of use—(1) Indications as in § 558.195. for use. For increased rate of weight gain in pasture cattle (slaughter, (ii) Melengestrol acetate alone or stocker, feeder, and dairy and beef re- with tylosin as in § 558.342. placement heifers). (iii) Ractopamine alone or in com- (2) Limitations. Provide 80 to 200 milli- bination as in § 558.500. grams of monensin (0.2 to 0.5 pounds of (iv) Tilmicosin alone or in combina- block) per head per day, at least 1 tion as in § 558.618. block per 5 head of cattle. Feed blocks (v) Zilpaterol alone or in combina- continuously. Do not feed salt or min- tion as in § 558.665. erals containing salt. The effectiveness [40 FR 13959, Mar. 27, 1975] of this block in cull cows and bulls has not been established. See paragraph EDITORIAL NOTE: For FEDERAL REGISTER ci- (d)(10)(i) of this section. tations affecting § 558.355, see the List of CFR (iii) Amount. 175 milligrams per Sections Affected, which appears in the Finding Aids section of the printed volume pound of protein-mineral block (0.038 and at www.fdsys.gov. percent). (a) Sponsor. See No. 017800 in EDITORIAL NOTE: At 79 FR 13545, Mar. 11, § 510.600(c) of this chapter. 2014, § 558.355 was amended; however, the (b) Conditions of use—(1) Indications amendment could not be incorporated due to inaccurate amendatory instruction. for use. For increased rate of weight gain in pasture cattle (slaughter, § 558.360 Morantel tartrate. stocker, and feeder). (2) Limitations. Provide 40 to 200 milli- (a) Approvals. Type A medicated arti- grams of monensin (0.25 to 1.13 pounds cles: 88 grams per pound to 066104 in or 4 to 18 ounces of block) per head per § 510.600(c) of this chapter. day, at least 1 block per 4 head of cat- (b) Related tolerances. See § 556.425 of tle. Do not allow cattle access to salt this chapter. or mineral while being fed this product. (c) Special considerations. (1) Do not Ingestion by cattle of monensin at lev- use in Type B or Type C medicated els of 600 milligrams per head per day feeds containing bentonite. and higher has been fatal. The effec- (2) Consult your veterinarian before tiveness of this block in cull cows and using in severely debilitated animals bulls has not been established. See and for assistance in the diagnosis, paragraph (d)(10)(i) of this section. treatment, and control of parasitism.

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(d) Conditions of use—(1) Amount. 0.44 (8) To 000986: 45.4 grams per pound for to 4.4 grams of morantel tartrate per use as in paragraph (d)(2) of this sec- pound of feed. tion. (2) Indications for use—(i) Cattle. For (b) Tolerances. See § 556.428 of this removal and control of mature gastro- chapter. intestinal nematode infections of cat- (c) Special considerations. An expira- tle including stomach worms tion date of 2 months (8 weeks) is re- (Haemonchus spp., Ostertagia spp., quired for narasin Type C medicated Trichostrongylus spp.), worms of the swine feeds. small intestine (Cooperia spp., (d) Conditions of use. It is used as fol- Trichostrongylus spp., Nematodirus spp.), lows: and worms of the large intestine (1) Broiler chickens—(i) Amount per (Oesophagostomum radiatum). ton. Narasin, 54 to 90 grams. (ii) Goats. For removal and control of (A) Indications for use. For prevention mature gastrointestinal nematode in- of coccidiosis caused by Eimeria fections of goats including Haemonchus necatrix, E. tenella, E. acervulina, E. contortus, Ostertagia (Teladorsagia) brunetti, E. mivati, and E. maxima. circumcincta, and Trichostrongylus axei. (B) Limitations. For broiler chickens (3) Limitations. Feed as a single thera- only. Feed continuously as sole ration. peutic treatment at 0.44 gram of Do not allow adult turkeys, horses, or morantel tartrate per 100 pounds of other equines access to narasin formu- body weight. Fresh water should be lations. Ingestion of narasin by these available at all times. When medicated species has been fatal. feed is consumed, resume normal feed- (ii) Amount per ton. Narasin, 27 to 45 ing. Conditions of constant worm expo- grams, plus nicarbazin, 27 to 45 grams. sure may require retreatment in 2 to 4 (A) Indications for use. For the pre- weeks. Do not treat cattle within 14 vention of coccidiosis caused by Eimeria days of slaughter; do not treat goats necatrix, E. tenella, E. acervulina, E. within 30 days of slaughter. brunetti, E. mivati, and E. maxima. (B) Limitations. For broiler chickens [46 FR 50950, Oct. 16, 1981, as amended at 47 only. Feed continuously as the sole ra- FR 53352, Nov. 26, 1982; 51 FR 7399, Mar. 3, tion. Do not feed to laying hens. Do not 1986; 51 FR 9005, Mar. 17, 1986; 52 FR 11642, allow adult turkeys, horses, or other Apr. 10, 1987; 59 FR 17922, Apr. 15, 1994; 66 FR 47963, Sept. 17, 2001] equines access to formulations containing narasin. Ingestion of narasin § 558.363 Narasin. by these animals has been fatal. With- draw 5 days before slaughter. The 2 (a) Approvals. Type A medicated arti- drugs can be combined only at a 1:1 cles containing specified levels of ratio for the 27 to 45 grams per ton narasin approved for sponsors identi- range. Only granular nicarbazin as pro- fied in § 510.600(c) of this chapter for use vided by No. 000986 in § 510.600(c) of this as in paragraph (d) of this section are chapter may be used in the combina- as follows: tion. (1) To 000986: 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 000986: 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. 000986; per pound bacitracin zinc, paragraph bambermycins by No. 016592 in (d)(1)(x) of this section. § 510.600(c) of this chapter.

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(iv) Amount per ton. Narasin 54 to 72 (B) Limitations. Feed continuously for grams, and bacitracin methylene disa- at least 4 weeks to swine during the licylate 10 to 50 grams. growing-finishing period as the sole ra- (A) Indications for use. For the pre- tion. No increased benefit in rate of vention of coccidiosis caused by Eimeria weight gain has been shown when acervulina, E. brunetti, E. maxima, E. narasin concentrations in the diet are mivati, E. necatrix, and E. tenella, for in- greater than 13.6 g/ton. Effectiveness creased rate of weight gain, and for im- has not been demonstrated when fed proved feed efficiency. for durations less than 4 weeks. Do not (B) Limitations. For broiler chickens allow adult turkeys, horses, or other only. Feed continuously as sole ration. equines access to narasin formulations. Do not feed to laying hens. Do not Ingestion of narasin by these species allow adult turkeys, horses, or other has been fatal. Not approved for use in equines access to narasin formulations. breeding animals because safety and ef- Ingestion of narasin by these species fectiveness have not been evaluated in has been fatal. Narasin as provided by these animals. Swine being fed with 000986, bacitracin methylene disalicy- narasin should not have access to feeds late by 046573 in § 510.600(c) of this chap- containing pleuromutilins (e.g., ter. tiamulin) as adverse reactions may (v) Amount per ton. Narasin, 54 to 72 occur. If signs of toxicity occur, dis- grams and bacitracin zinc, 4 to 50 continue use. grams. (ii) Amount per ton. Narasin, 18.1 to (A) Indications for use. For the pre- 27.2 grams. vention of coccidiosis caused by Eimeria (A) Indications for use. For increased necatrix, E. tenella, E. acervulina, E. rate of weight gain and improved feed brunetti, E. mivati, and E. maxima, and efficiency when fed for at least 4 weeks. for increased rate of weight gain and (B) Limitations. Feed continuously for improved feed efficiency. at least 4 weeks to swine during the (B) Limitations. For broiler chickens growing-finishing period as the sole ra- only. Feed continuously as sole ration. tion. No increased benefit in rate of Do not allow adult turkeys, horses, or weight gain has been shown when other equines access to formulations narasin concentrations in the diet are containing narasin. Ingestion of greater than 13.6 g/ton. Effectiveness narasin by these species has been fatal. has not been demonstrated when fed Narasin as provided by 000986, baci- for durations less than 4 weeks. Do not tracin zinc by 046573 in § 510.600(c) of allow adult turkeys, horses, or other this chapter. equines access to narasin formulations. (vi) Amount per ton. Narasin, 54 to 72 Ingestion of narasin by these species grams, plus tylosin, 4 to 50 grams. has been fatal. Not approved for use in (A) Indications for use. As an aid in breeding animals because safety and ef- the prevention of coccidiosis caused by fectiveness have not been evaluated in Eimeria necatrix, E. tenella, E. these animals. Swine being fed with acervulina, E. brunetti, E. mivati, and E. narasin should not have access to feeds maxima, for increased rate of weight containing pleuromutilins (e.g., gain, and improved feed efficiency. tiamulin) as adverse reactions may (B) Limitations. For broiler chickens occur. If signs of toxicity occur, dis- only. Feed continuously as sole ration. continue use. Do not allow adult turkeys, horses, or (3) Narasin may also be used for other equines access to formulations broilers in combination with: containing narasin. Ingestion of (i) Nicarbazin with lincomycin as in narasin by these species has been fatal. § 558.366. Narasin and tylosin as provided by (ii) Nicarbazin and bacitracin meth- 000986 in § 510.600(c) of this chapter. ylene disalicylate as in § 558.366. (2) Growing-finishing swine—(i) [51 FR 29098, Aug. 14, 1986] Amount per ton. Narasin, 13.6 to 27.2 EDITORIAL NOTE: For FEDERAL REGISTER ci- grams. tations affecting § 558.363, see the List of CFR (A) Indications for use. For increased Sections Affected, which appears in the rate of weight gain when fed for at Finding Aids section of the printed volume least 4 weeks. and at www.fdsys.gov.

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EDITORIAL NOTE: At 79 FR 13545, Mar. 11, (b) Related tolerances. See § 556.430 of 2014, § 558.363 was amended; however, the this chapter. amendment could not be incorporated due to (c) [Reserved] inaccurate amendatory instruction. (d) Conditions of use. Neomycin sul- § 558.364 Neomycin sulfate. fate is used as follows: (a) Approvals. Type A medicated article: 325 grams per pound to 054771 in § 510.600(c) of this chapter.

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..

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Neomycin Sulfate Combination Indications for Use Limitations Sponsor

(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]

§ 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. 000986, 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:

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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) ...... 000986 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- 000986 bacitracin meth- cidiosis caused by Eimeria tenella, tion. Withdraw 5 days before ylene disalicylate 4 E. necatrix, E. acervulina, E. maxi- slaughter. Do not allow tur- 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 000986, bacitracin methylene disalicylate by 054771. Narasin 27 to 45 and Broiler chickens: For prevention of Feed continuously as sole ra- 054771 bacitracin meth- coccidiosis caused by Eimeria tion. Do not feed to laying ylene disalicylate tenella, E. necatrix, E. acervulina, hens. Withdraw 5 days be- 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. 000986, bacitracin methylene disalicylate by No. 054771 in § 510.600(c) of this chapter.. Narasin 27 to 45 and Broiler chickens: For prevention of To control necrotic enteritis, 054771 bacitracin meth- coccidiosis caused by Eimeria start medication at first clin- ylene disalicylate tenella, E. necatrix, E. acervulina, ical signs of disease; vary 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. 000986, bacitracin methylene disalicylate 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- 000986 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.

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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; prevention of coc- Feed continuously as sole ra- 000986 Lincomycin 2 to 4. cidiosis caused by Eimeria tenella, tion. Withdraw 5 days before E. necatrix, E. acervulina, E. maxi- slaughter. Do not allow tur- 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. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Inges- tion by these species may result in severe gastrointestinal effects. Narasin and nicarbazin as provided by 000986, lincomycin by 054771. 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 methylene Broiler chickens: As an aid in pre- Feed continuously as sole ra- 054771 disalicylate 4 to 50. venting outbreaks of cecal (Eimeria tion from time chicks are 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 methylene disalicylate as provided by No. 054771 in § 510.600(c) of this chapter. Bacitracin methylene Broiler chickens: As an aid in pre- Feed continuously as sole ra- 066104 disalicylate 30. venting outbreaks of cecal (Eimeria tion from time chicks are 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 methylene disalicylate 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 methylene Broiler chickens: As an aid in pre- Feed continuously as sole ra- 054771 disalicylate 50. venting outbreaks of cecal (Eimeria tion from time chicks are 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 methylene disalicylate 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- 000986 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 methylene Broiler chickens; aid in preventing ...... do ...... 060728 disalicylate 30. outbreaks of cecal (Eimeria tenella) 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.. 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..

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

Lincomycin 2 Broiler chickens; aid in preventing Feed continuously as sole ra- 060728 (0.00044 pct). outbreaks of secal (Eimeria tenella) tion from time chicks are 066104 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.. as a treatment for coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter..

[42 FR 56729, Oct. 28, 1977; 43 FR 1942, Jan. 13, 1978, as amended at 44 FR 40887, July 13, 1979; 50 FR 13562, Apr. 5, 1985; 51 FR 7399, Mar. 3, 1986; 54 FR 1928, Jan. 18, 1989; 60 FR 29483, June 5, 1995; 61 FR 1832, Jan. 24, 1996; 61 FR 14021, Mar. 29, 1996; 61 FR 14483, Apr. 2, 1996; 62 FR 29011, May 29, 1997; 63 FR 13124, Mar. 18, 1998; 63 FR 57248, Oct. 27, 1998; 64 FR 4966, Feb. 2, 1999; 64 FR 18574, Apr. 15, 1999; 64 FR 20164, Apr. 26, 1999; 64 FR 49384, Sept. 13, 1999; 65 FR 11889, Mar. 7, 2000; 66 FR 46706, Sept. 7, 2001; 66 FR 47962, Sept. 17, 2001; 66 FR 63500, Dec. 7, 2001; 67 FR 30327, May 6, 2002; 71 FR 16224, Mar. 31, 2006; 71 FR 27957, May 15, 2006; 73 FR 15884, Mar. 26, 2008; 75 FR 7555, Feb. 22, 2010; 79 FR 42007, July 15, 2013; 78 FR 52429, Aug. 23, 2013; 79 FR 10983, Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014]

§ 558.369 Nitarsone. medication is essential to prevent spread of disease. Adequate drinking (a) Approvals. Type A medicated arti- water must be provided near feeders at cles: 50 percent to 054771 in § 510.600(c) all times. Overdosage or lack of water of this chapter. may result in leg weakness or paral- (b) Related tolerances. See § 556.60 of ysis. The drug is not effective in pre- this chapter. venting blackhead in birds infected (c) [Reserved] more than 4 or 5 days. Discontinue use (d) Conditions of use. It is used as fol- 5 days before slaughtering animals for lows: human consumption to allow elimi- (1) Chickens and turkeys—(i) Amount. nation of the drug from edible tissues. Nitarsone, 0.01875 percent. The drug is dangerous for ducks, geese, (ii) Indications for use. As an aid in and dogs. Use as sole source of arsenic. the prevention of blackhead. (iii) Limitations. Early medication is [46 FR 47535, Sept. 29, 1981, as amended at 47 essential to prevent spread of disease. FR 14152, Apr. 2, 1982; 51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 55 FR 8460, Mar. 8, Adequate drinking water must be pro- 1990; 57 FR 8578, Mar. 11, 1992; 63 FR 39028, vided near feeder at all times. The drug July 21, 1998; 71 FR 16223, Mar. 31, 2006; 79 FR is not effective in preventing black- 13545, Mar. 11, 2014] head in birds infected more than 4 or 5 days. Discontinue use 5 days before § 558.415 Novobiocin. slaughtering animals for human con- (a) Specifications. Type A medicated sumption to allow elimination of the article containing 25 grams of drug from edible tissues. The drug is novobiocin activity per pound. dangerous for ducks, geese, and dogs. (b) Sponsor. See No. 054771 in Overdosage or lack of water may result § 510.600(c) of this chapter. in leg weakness or paralysis. Use as (c) Related tolerances. See § 556.460 of sole source of arsenic. this chapter. (2) Turkeys—(i) Amount. Nitarsone (d) Conditions of use. It is used in ani- 0.01875 percent, plus bacitracin meth- mal feeds as follows: ylene disalicylate or bacitracin zinc 4 (1) Chickens—(i) Amount. Novobiocin, to 50 grams per ton. 6–7 mgs. per lb. body weight per day. (ii) Indications for use. As an aid in (a) Indications for use. Aid in the the prevention of blackhead, and for in- treatment of breast blisters associated creased rate of weight gain and im- with staphylococcal infections suscep- proved feed efficiency. tible to novobiocin. (iii) Limitations. For growing turkeys. (b) Limitations. Administer, as sole ra- Feed continuously as sole ration. Early tion, feed which contains not less than

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200 grams of novobiocin activity per (ii) Indications for use. For treatment ton of feed; not for laying chickens; of generalized infections, abscesses, or feed 5 to 7 days; withdraw 4 days before urinary infections caused by staphy- slaughter. lococcal or other novobiocin sensitive (ii) Amount. Novobiocin, 10–14 mgs. organisms. per lb. body weight per day. (iii) Limitations. Administer, as sole (a) Indications for use. Treatment of ration, feed which contains not less staphylococcal synovitis and general- than 200 grams of novobiocin activity ized staphylococcal infections suscep- per ton of feed; feed for 7 days. tible to novobiocin. (4) Ducks—(i) Amount. Novobiocin, 350 (b) Limitations. Administer, as sole ra- grams per ton. tion, feed which contains not less than 350 grams of novobiocin activity per (ii) Indications for use. Control of in- ton of feed; not for laying chickens; fectious serositis and fowl cholera in feed 5 to 7 days; withdraw 4 days before ducks caused by Pasteurella slaughter. anatipestifer and P. multocida, suscep- (2) Turkeys—(i) Amount. Novobiocin, tible to novobiocin. 4–5 mgs. per lb. body weight per day. (iii) Limitations. Administer, as sole (a) Indications for use. Aid in the ration, for 5 to 7 days, continue medi- treatment of breast blisters associated cation for 14 days if necessary, repeat if with staphylococcal infections suscep- reinfection occurs; discontinue use at tible to novobiocin. least 3 days before slaughter; not for (b) Limitations. Administer, as sole ra- use in laying ducks. tion, feed which contains not less than [40 FR 13959, Mar. 27, 1975, as amended at 45 200 grams of novobiocin activity per FR 42263, June 24, 1980; 51 FR 7399, Mar. 3, ton of feed; not for laying turkeys; feed 1986; 52 FR 36402, Sept. 29, 1987; 79 FR 13545, 5 to 7 days; withdraw 4 days before Mar. 11, 2014] slaughter. (ii) Amount. Novobiocin, 5–8 mgs. per § 558.430 Nystatin. lb. body weight per day. (a) Specifications. Type A medicated (a) Indications for use. Aid in the control of recurring outbreaks of fowl article containing 20 grams of nystatin cholera caused by strains of Pasteurella activity per pound. multocida susceptible to novobiocin fol- (b) Sponsor. See No. 054771 in lowing initial treatment with 7–8 mgs. § 510.600(c) of this chapter. per pound body weight per day. (c) Related tolerances. See § 556.470 of (b) Limitations. Administer, as sole ra- this chapter. tion, feed which contains not less than (d) Conditions of use. It is used for 200 grams of novobiocin activity per chickens and turkeys as follows: ton of feed; feed 5 to 7 days; not for lay- (1) Amount. 50 grams per ton. ing turkeys; withdraw 4 days before (i) Indications for use. Chickens and slaughter. turkeys; aid in control of crop mycosis (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 outbreaks of fowl cholera caused by (i) Indications for use. Chickens and strains of Pasteurella multocida suscep- turkeys; treatment of crop mycosis and tible to novobiocin. mycotic diarrhea (Candida albicans). (b) Limitations. Administer, as sole ra- (ii) Limitations. Growing and laying tion, feed which contains not less than chickens; growing turkeys; to be fed 350 grams of novobiocin activity per for 7 to 10 days. ton of feed; feed 5 to 7 days; not for lay- [41 FR 11002, Mar. 15, 1976, as amended at 51 ing turkeys; withdraw 4 days before FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; slaughter. 53 FR 40729, Oct. 18, 1988; 55 FR 8461, Mar. 8, (3) Mink—(i) Amount. 20 mgs. per lb. 1990; 57 FR 8578, Mar. 11, 1992; 79 FR 13545, body weight per day. Mar. 11, 2014]

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§ 558.435 Oleandomycin. (1) 10, 20, 30, 50, 100, and 200 grams per (a) Approvals. Type A medicated arti- pound to No. 066104 in § 510.600(c) of this cles: 5 grams of activity per pound to chapter. 066104 in § 510.600(c) of this chapter. (2) 50, 100, and 200 grams per pound to (b) Related tolerances. See § 556.480 of No. 048164 in § 510.600(c) of this chapter. this chapter. (b) Special considerations. (1) In ac- (c) Special considerations. Do not use cordance with § 558.5 labeling shall bear bentonite in Type B or Type C medi- the statement: ‘‘FOR USE IN DRY cated feeds containing oleandomycin. ANIMAL FEED ONLY. NOT FOR USE Oleandomycin refers to oleandomycin IN LIQUID FEED SUPPLEMENTS.’’ or feed-grade oleandomycin. (2) The articles in paragraph (a)(1) of (d) Conditions of use. It is used in ani- this section contain an amount of mal feed as follows: mono-alkyl (C8–C18) (1) Chickens and turkeys—(i) Amount trimethylammonium oxytetracycline per ton. Oleandomycin, 1 to 2 grams. expressed in terms of an equivalent (ii) Indications for use. For increased amount of oxytetracycline hydro- rate of weight gain and improved feed chloride or an amount of oxytetra- efficiency for broiler chickens and cycline dihydrate base expressed in growing turkeys. terms of an equivalent amount of oxy- (2) Swine—(i) Amount per ton. tetracycline hydrochloride. Oleandomycin, 5 to 11.25 grams. (3) 50-, 100-, and 200-gram per pound (ii) Indications for use. For increased articles in paragraph (a)(2) of this sec- rate of weight gain and improved feed tion contain oxytetracycline dihydrate efficiency in growing-finishing swine. expressed in terms of an equivalent [40 FR 13959, Mar. 27, 1975, as amended at 44 amount of oxytetracycline hydro- FR 40283, July 10, 1979; 51 FR 7399, Mar. 3, chloride. Another 100-gram per pound 1986; 52 FR 2686, Jan. 26, 1987; 66 FR 47963, article in paragraph (a)(2) of this sec- Sept. 17, 2001] tion contains oxytetracycline hydrochloride. § 558.450 Oxytetracycline. (c) Related tolerances. See § 556.500 of (a) Approvals. Type A medicated arti- this chapter. cles: (d) Conditions of use—(1) Chickens—

Oxytetracycline amount Indications for use Limitations Sponsor

(i) 10 to 50 grams per Chickens: For increased rate of weight gain Feed continuously; do not feed to chickens 066104, ton (g/ton). and improved feed efficiency.. producing eggs for human consumption.. 048164

(ii) 100 to 200 g/ton ...... Chickens: For control of infectious synovitis Feed continuously for 7 to 14 days (d); do 066104, caused by Mycoplasma synoviae and not feed to chickens producing eggs for 048164 control of fowl cholera caused by human consumption; in low calcium Pasteurella multocida susceptible to oxy- feeds, withdraw 3 d before slaughter.. tetracycline..

(iii) 400 g/ton ...... 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 048164 caused by Mycoplasma gallisepticum and human consumption; in low calcium Escherichia coli susceptible to oxytetra- feeds, withdraw 3 d before slaughter.. cycline..

(iv) 500 g/ton ...... Chickens: For reduction of mortality due to Feed continuously for 5 d; do not feed to 066104, air sacculitis (air sac infection) caused by chickens producing eggs for human con- 048164 E. coli susceptible to oxytetracycline.. sumption; withdraw 24 hours before slaughter; in low calcium feeds, withdraw 3 d before slaughter..

(2) Turkeys—

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Oxytetracycline amount Indications for use Limitations Sponsor

(i) 10 to 50 g/ton ... Growing turkeys: For Feed continuously; do not feed to turkeys 066104, increased rate of producing eggs for human consumption.. 048164 weight gain and improved feed efficiency..

(ii) 100 g/ton ...... Turkeys: For control of Feed continuously for 7 to 14 d; do not 066104, hexamitiasis caused feed to turkeys producing eggs for 048164 by Hexamita human consumption.. meleagridis susceptible to oxytetracycline..

(iii) 200 g/ton ...... Turkeys: For control of Feed continuously for 7 to 14 d; for No. 066104, infectious synovitis 066104 withdraw 5 d before slaughter; 048164 caused by M. for No. 048164 zero-day withdrawal synoviae susceptible time; do not feed to turkeys producing to oxytetracycline.. eggs for human consumption..

(iv) 25 milligrams/ Turkeys: For control of Feed continuously for 7 to 14 d; for No. 066104, pound (mg/lb) of complicating bacterial 066104 withdraw 5 d before slaughter; 048164 body weight organisms associated for No. 048164 zero-day withdrawal daily. with bluecomb (trans- time; do not feed to turkeys producing missible enteritis; eggs for human consumption.. coronaviral enteritis) susceptible to oxytetracycline..

(3) Swine—

Oxytetracycline amount Indications for use Limitations Sponsor

(i) 10 to 50 g/ton ... Swine: For increased Feed continuously...... 066104, rate of weight gain 048164 and improved feed efficiency..

(ii) 10 mg/lb of 1. Swine: For treatment Feed continuously for 7 to 14 d...... 066104, body weight of bacterial enteritis 048164 daily. caused by E. coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by P. multocida susceptible to oxytetracycline...... 2. Breeding swine: For Feed continuously for 14 d...... 066104, control and treatment 048164 of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline..

(4) Cattle—

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Oxytetracycline amount Indications for use Limitations Sponsor

(i) 0.05 to 0.1 mg/ Calves (up to 250 lb): Feed continuously in milk replacer or start- 066104, lb of body weight For increased rate of er feed.. 048164 daily. weight gain and improved feed efficiency..

(ii) 10 mg/lb of 1. Calves and beef and Feed continuously for 7 to 14 d; for No. 066104, body weight nonlactating dairy 048164, withdraw 5 d before slaughter; 048164 daily. cattle: For treatment for No. 066104, zero-day withdrawal of bacterial enteritis time.. caused by E. coli and bacterial pneumonia (shipping fever complex) caused by P. multocida susceptible to oxytetracycline...... 2. Calves: For treat- Feed continuously for 7 to 14 d in milk re- 066104, ment of bacterial en- placer or starter feed; for No. 048164, 048164 teritis caused by E. withdraw 5 d before slaughter; for No. coli susceptible to ox- 066104, zero-day withdrawal time.. ytetracycline..

(iii) 25 mg/head/ Calves (250 to 400 lb): Feed continuously...... 066104, day. For increased rate of 048164 weight gain and improved feed efficiency..

(iv) 75 mg/head/ Growing cattle (over Feed continuously...... 066104, day. 400 lb): For in- 048164 creased rate of weight gain, improved feed efficiency, and reduction of liver condemnation due to liver abscesses..

(v) 0.5 to 2.0 g/ Cattle: For prevention Feed 3 to 5 d before and after arrival in 066104, head/day. and treatment of the feedlots.. 048164 early stages of shipping fever complex..

(5) Minor species—

Oxytetracycline amount Indications for use Limitations Sponsor

(i) 10 to 20 g/ton ... Sheep: For increased Feed continuously...... 066104, rate of weight gain 048164 and improved feed efficiency..

(ii) 10 mg/lb of Sheep: For treatment of Feed continuously for 7 to 14 d; withdraw 066104, body weight bacterial enteritis 5 d before slaughter.. 048164 daily. caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to oxytetracycline..

(iii) 200 mg/colony Honey bees: For con- Remove at least 6 weeks prior to main 066104, trol of American honey flow.. 048164 foulbrood caused by Paenibacillus larvae and European foulbrood caused by Streptococcus pluton susceptible to oxytetracycline..

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Oxytetracycline amount Indications for use Limitations Sponsor

(iv) 250 mg/kilo- Pacific salmon: For For salmon not over 30 g body weight; ad- 066104 gram of fish/day marking of skeletal minister as sole ration for 4 consecutive (11.35 g/100 lb tissue.. days; fish not to be liberated for at least of fish/day). 7 d following the last administration of medicated feed..

(v) 2.5 to 3.75 g/ 1. Salmonids: For con- Administer in mixed ration for 10 d; do not 066104 100 lb of fish/ trol of ulcer disease liberate fish or slaughter fish for food for day. caused by 21 d following the last administration of Hemophilus piscium, medicated feed.. furunculosis caused by Aeromonas salmonicida, bacterial hemorrhagic septicemia caused by A. liquefaciens, and pseudomonas disease...... 2. Catfish: For control Administer in mixed ration for 10 d; do not 066104 of bacterial hemor- liberate fish or slaughter fish for food for rhagic septicemia 21 d following the last administration of caused by A. medicated feed; do not administer when liquefaciens and water temperature is below 16.7 °C (62 pseudomonas dis- °F).. ease..

(vi) 3.75 g/100 lb 1. Freshwater-reared Administer in mixed ration for 10 d; do not 066104 of fish/day. salmonids: For con- liberate fish or slaughter fish for food for trol of mortality due 21 d following the last administration of to coldwater disease medicated feed.. associated with Flavobacterium psychrophilum...... 2. Freshwater-reared Administer in mixed ration for 10 d; do not 066104 Oncorhynchus liberate fish or slaughter fish for food for mykiss: For control of 21 d following the last administration of mortality due to medicated feed.. columnaris disease associated with Flavobacterium columnare..

(vii) 1 g/lb of medi- Lobsters: For control of Administer as sole ration for 5 consecutive 066104 cated feed. gaffkemia caused by days; withdraw medicated feed 30 d be- Aerococcus viridans.. fore harvesting lobsters..

(6) Oxytetracycline may be used in § 558.455 Oxytetracycline and neomy- accordance with the provisions of this cin. section in the combinations as follows: (a) Specifications. Type A medicated (i) Carbadox as in § 558.115. articles containing oxytetracycline (ii) Lasalocid as in § 558.311. equivalent to 50 grams per pound (g/lb) (iii) Melengestrol acetate as in oxytetracycline hydrochloride and 50 g/ § 558.342. lb neomycin sulfate or oxytetracycline (iv) Robenidine hydrochloride as in equivalent to 100 g/lb oxytetracycline § 558.515. hydrochloride and 100 g/lb neomycin (v) Salinomycin as in § 558.550. sulfate. [61 FR 51590, Oct. 3, 1996, as amended at 63 FR (b) Sponsors. See Nos. 048164 and 41192, Aug. 3, 1998; 66 FR 32740, June 18, 2001; 066104 in § 510.600(c) of this chapter. 66 FR 45167, Aug. 28, 2001; 66 FR 47963, Sept. (c) Related tolerances. See §§ 556.430 17, 2001; 67 FR 51081, Aug. 7, 2002; 69 FR 28821, and 556.500 of this chapter. May 19, 2004; 69 FR 51173, Aug. 18, 2004; 69 FR (d) Special considerations. Cattle feeds 62407, Oct. 26, 2004; 71 FR 27958, May 15, 2006; 71 FR 44887, Aug. 8, 2006; 71 FR 53006, Sept. 8, shall bear the following warning state- 2006; 72 FR 70774, Dec. 13, 2007; 73 FR 45875, ment: ‘‘Use of more than one product Aug. 7, 2008]

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containing neomycin or failure to fol- (e) Indications for use—(1) Chickens. It low withdrawal times may result in il- is used in feed as follows: legal drug residues.’’

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

(i) 10 to 50 ...... Chickens: For increased rate of weight gain Feed continuously; do not feed to chickens 048164 and improved feed efficiency.. producing eggs for human consumption; 066104 in low calcium feeds withdraw 3 days before slaughter..

(ii) 100 to 200 ...... Chickens: For control of infectious synovitis Feed continuously for 7 to 14 d; do not 048164 caused by Mycoplasma synoviae; control feed to chickens producing eggs for 066104 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 048164 disease (CRD) and air sac infection feed to chickens producing eggs for 066104 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 048164 air sacculitis (air-sac- infection) caused chickens producing eggs for human con- 066104 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) 10 to 50 grams per Growing turkeys: For increased rate of Feed continuously; do not feed to turkeys 048164 ton (g/ton) of feed. weight gain and improved feed efficiency.. producing eggs for human consumption.. 066104

(ii) 100 g/ton of feed ..... Turkeys: For control of hexamitiasis caused Feed continuously for 7 to 14 d; do not 048164 by Hexamita meleagridis susceptible to feed to turkeys producing eggs for 066104 oxytetracycline.. human consumption..

(iii) 200 g/ton of feed .... Turkeys: For control of infectious synovitis Feed continuously for 7 to 14 d; withdraw 5 048164 caused by M. synoviae susceptible to ox- d before slaughter; do not feed to turkeys 066104 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 048164 grams per pound terial organisms associated with d before slaughter; do not feed to turkeys 066104 (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) 10 to 50 g/ton of Swine: For increased rate of weight gain Feed continuously...... 048164 feed. and improved feed efficiency.. 066104

(ii) To provide 10 mg/lb 1. Swine: For treatment of bacterial enteritis Feed continuously for 7 to 14 d; withdraw 5 048164 of body weight daily.. caused by E. coli and Salmonella d before slaughter.. 066104 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; 048164 ment of leptospirosis (reducing the inci- withdraw 5 d before slaughter.. 066104 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:

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Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors

(i) 10 to 20 g/ton of Sheep: For increased rate of weight gain Feed continuously...... 048164 feed. and improved feed efficiency.. 066104

(ii) To provide 0.05 to Calves (up to 250 lb): For increased rate of Feed continuously; in milk replacers or 048164 0.1 mg/lb of body weight gain and improved feed efficiency.. starter feed.. 066104 weight daily..

(iii) To provide 10 mg/lb 1. Calves and beef and nonlactating dairy Feed continuously for 7 to 14 d; in feed or 048164 of body weight daily.. cattle: For treatment of bacterial enteritis milk replacers. If symptoms persist after 066104 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- 048164 bacterial enteritis caused by E. coli sus- placers or starter feed. If symptoms per- 066104 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- 048164 itis caused by E. coli and bacterial pneu- toms persist after using for 2 or 3 days, 066104 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) To provide 25 mg/ Calves (250 to 400 lb): For increased rate Feed continuously...... 048164 head/day. of weight gain and improved feed effi- 066104 ciency..

(v) To provide 75 mg/ Growing cattle (over 400 lb): For increased Feed continuously...... 048164 head/day. rate of weight gain; improved feed effi- 066104 ciency, and reduction of liver condemnation due to liver abscesses..

(vi) To provide 0.5 to Cattle: For prevention and treatment of the Feed 3 to 5 d before and after arrival in 048164 2.0 g/head/ day. early stages of shipping fever complex.. feedlots. A withdrawal period has not 066104 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]

§ 558.460 Penicillin. pound. To 054771, 100 and 227 grams per (a) Specifications. As penicillin pro- pound. caine G or feed grade penicillin pro- (c) Related tolerances. See § 556.510 of caine. this chapter. (b) Sponsors. Type A medicated arti- (d) Conditions of use. (1) It is used as cles: To 066104, 100 and 227 grams per follows:

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

(i) 2.4 to 50 ...... Chickens, turkeys, and pheasants; for Do not feed to poultry pro- 054771, increased rate of weight gain and ducing eggs for human con- 066104. improved feed efficiency.. sumption.. (ii) 5 to 20...... Quail; for increased rate of weight Quail; not over 5 weeks of age. 054771, gain and improved feed efficiency.. 066104. (iii) 10 to 50 ...... Swine; for increased rate of weight ...... 054771, gain and improved feed efficiency.. 066104.

(2) [Reserved] § 558.465 Poloxalene free-choice liquid Type C feed. [41 FR 11004, Mar. 15, 1976, as amended at 42 FR 18618, Apr. 8, 1977; 42 FR 36995, July 19, (a) Approvals. Type A medicated arti- 1977; 47 FR 42103, Sept. 24, 1982; 51 FR 7399, cles: 99.5 percent to 066104 in § 510.600(c) Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 58 FR of this chapter. 30120, May 26, 1993; 60 FR 39847, Aug. 4, 1995; (b) Conditions of use. (1) For control of 63 FR 36179, July 2, 1998; 65 FR 45880, July 26, legume (alfalfa, clover) and wheat pas- 2000; 66 FR 47963, Sept. 17, 2001; 71 FR 16227, ture bloat in cattle, use 7.5 grams of Mar. 31, 2006; 78 FR 52430, Aug. 23, 2013; 79 FR poloxalene per pound of liquid Type C 10983, Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014] feed (1.65 percent weight/weight). Each § 558.464 Poloxalene. animal must consume 0.2 pound of Type C feed per 100 pounds of body (a) Approvals. (1) Dry Type A medi- weight daily for adequate protection. cated articles: 53 percent to 054771 in (2) For control of legume (alfalfa, clo- § 510.600(c) of this chapter. ver) bloat in cattle grazing of prebloom (2) Liquid Type A medicated articles: legumes, use 10.00 grams of poloxalene 99.5 percent to 054771 in § 510.600(c) of per pound of liquid Type C feed (2.2 per- this chapter. cent weight/weight). Each animal must (b) Conditions of use. (1) For preven- consume 0.15 pound of Type C feed per tion of legume (alfalfa, clover) and 100 pounds of body weight daily for ade- wheat pasture bloat in cattle. quate protection. If consumption ex- (2) Poloxalene dry Type A article and ceeds 0.2 pound of Type C feed per 100 liquid Type A article must be thor- pounds of body weight daily, cattle oughly blended and evenly distributed should be changed to a Type C feed in feed prior to use. This may be ac- containing 7.5 grams of poloxalene per complished by adding the Type A arti- pound. cle to a small quantity of feed, mixing (3) Poloxalene liquid Type A article thoroughly, then adding this mixture must be thoroughly blended and evenly to the remaining feed and again mixing distributed into a liquid Type C feed and offered to cattle in a covered liquid thoroughly. Dosage is 1 gram of Type C feed feeder with lick wheels. poloxalene per 100 pounds of body The formula for the liquid Type C feed, weight daily and continued during ex- on a weight/weight basis, is as follows: posure to bloat producing conditions. If Ammonium polyphosphate 2.66 percent, bloating conditions are severe, the dose phosphoric acid (75 percent) 3.37 per- is doubled. Treatment should be start- cent, sulfuric acid 1.00 percent, water ed 2 to 3 days before exposure to bloat- 10.00 percent, and molasses sufficient producing conditions. Repeat dosage if to make 100.00 percent, vitamins A and animals are exposed to bloat-producing D and/or trace minerals may be added. conditions more than 12 hours after the One free-turning lick wheel per 25 head last treatment. Do not exceed the high- of cattle must be provided. er dosage levels in any 24-hour period. (4) The medicated liquid Type C feed must be introduced at least 2 to 5 days [40 FR 39857, Aug. 29, 1975, as amended at 51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; before legume consumption to accus- 56 FR 50654, Oct. 8, 1991; 60 FR 55660, Nov. 2, tom the cattle to the medicated liquid 1995; 79 FR 13545, Mar. 11, 2014] Type C feed and to lick wheel feedings. If the medicated liquid wheel Type C feed feeding is interrupted, this 2- to 5-

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day introductory feeding should be re- (B) Limitations. Feed for 3 days as the peated. sole ration in a Type C feed; withdraw 24 hours prior to slaughter. [40 FR 13959, Mar. 27, 1975, as amended at 42 FR 21281, Apr. 26, 1977; 51 FR 7399, Mar. 3, (iii) Amount per ton. 800 grams (0.0881 1986; 52 FR 2686, Jan. 26, 1987; 56 FR 50654, percent). Oct. 8, 1991; 60 FR 55660, Nov. 2, 1995; 66 FR (A) Indications for use. For the re- 47963, Sept. 17, 2001] moval and control of large roundworm (Ascaris suum) and nodular worm § 558.485 Pyrantel. (Oesophagostomum) infections. (a) Specifications. Type A medicated (B) Limitations. As sole ration for a articles containing 9.6, 19.2, 48, or 80 single therapeutic treatment in Type C grams per pound pyrantel tartrate. feed; feed at the rate of 1 lb of feed per (b) Approvals. See sponsors in 40 lb of body weight for animals up to § 510.600(c) of this chapter for uses as in 200 lb, and 5 lb of feed per head for ani- paragraph (e) of this section: mals 200 lb or over; withdraw 24 hours (1) No. 066104: 9.6, 19.2, 48, and 80 prior to slaughter. grams per pound for use as in para- (iv) Amount per ton. Pyrantel tar- graph (e)(1) of this section. trate, 96 grams (0.0106 percent) and (2) [Reserved] carbadox, 50 grams (0.0055 percent). (3) No. 017790: 9.6 and 19.2 grams per (A) Indications for use. For control of pound for use as in paragraphs (e)(1)(i) swine dysentery (vibrionic dysentery, through (e)(1)(iii) of this section. bloody scours or hemorrhagic dysentery); control of bacterial swine en- (4) [Reserved] teritis (salmonellosis or necrotic enter- (5) No. 051311: 19.2 and 48 grams per itis caused by Salmonella choleraesuis); pound for use as in paragraphs (e)(1)(i) aid in the prevention of migration and through (e)(1)(iii) of this section. establishment of large roundworm (6) No. 034936: 9.6 and 19.2 grams per (Ascaris suum) infections; aid in the pound for use as in paragraphs (e)(1)(i) prevention of establishment of nodular and (e)(1)(ii) of this section. worm (Oesophagostomum) infections. (7) Nos. 017135 and 054771: 48 grams (B) Limitations. Do not feed to swine per pound for use as in paragraph (e)(2) weighing over 75 pounds; do not feed of this section. within 10 weeks of slaughter; consult a (c) Related tolerances. See § 556.560 of veterinarian before feeding to severely this chapter. debilitated animals; feed continuously (d) Special considerations. (1) See as sole ration. Do not use in Type C § 500.25 of this chapter. Consult a vet- feeds containing less than 15 percent erinarian before using in severely de- crude protein. bilitated animals. (v) Amount per ton. Pyrantel tartrate, (2) Do not mix in Type B or Type C 96 grams (0.0106 percent) and tylosin, 40 medicated feeds containing bentonite. to 100 grams, as tylosin phosphate. (e) Conditions of use. It is used as fol- (A) Indications for use. For prevention lows: of swine dysentery (vibrionic); aid in (1) Swine—(i) Amount per ton. 96 the prevention of migration and estab- grams (0.0106 percent). lishment of large roundworms (Ascaris (A) Indications for use. Aid in the pre- suum) infections; aid in the prevention vention of migration and establish- of establishment of nodular worm ment of large roundworm (Ascaris (Oesophagostomum spp. ) infections. suum) infections; aid in the prevention (B) Limitations. Use 100 grams tylosin of establishment of nodular worm per ton for at least 3 weeks followed by (Oesophagostomum) infections. 40 grams tylosin per ton until market (B) Limitations. Feed continuously as weight; withdraw 24 hours before the sole ration in a Type C feed; with- slaughter. Consult your veterinarian draw 24 hours prior to slaughter. before feeding to severely debilitated (ii) Amount per ton. 96 grams (0.0106 animals and for assistance in the diag- percent). nosis, treatment, and control of para- (A) Indications for use. For the re- sitism. moval and control of large roundworm (vi) Amount per ton. Pyrantel tar- (Ascaris suum) infections. trate, 96 grams (0.0106 percent) and

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tylosin 40 to 100 grams, as tylosin phos- ton; feed as sole ration; not to be fed to phate. swine that weigh more than 250 pounds; (A) Indications for use. Treatment and withdraw 6 days before slaughter. Con- control of swine dysentery (vibrionic); sult your veterinarian before feeding to aid in the prevention of migration and severely debilitated animals and for as- establishment of large roundworm sistance in the diagnosis, treatment, (Ascaris suum) infections; aid in the and control of parasitism. prevention of establishment of nodular (ix) Amount per ton. Pyrantel tar- worm (Oesophagostomum spp. ) infec- trate, 96 grams (0.0106 percent) and lin- tions. comycin, 100 grams, as lincomycin hy- (B) Limitations. Administer tylosin in drochloride monohydrate. feed as tylosin phosphate after treat- (A) Indications for use. For treatment ment with tylosin in drinking water as of swine dysentery; aid in the preven- tylosin base; 0.25 grams per gallon in tion of migration and establishment of drinking water for 3 to 10 days, 40 to large roundworm (Ascaris suum) infec- 100 grams tylosin per ton in feed for 2 tions; aid in the prevention of estab- to 6 weeks; withdraw 24 hours before lishment of nodular worm slaughter. Consult your veterinarian (Oesophagostomum spp.) infections. before feeding to severely debilitated (B) Limitations. Feed 100 grams per animals and for assistance in the diag- ton 3 weeks or until signs of disease nosis, treatment, and control of para- disappear, followed by 40 grams per sitism. ton; feed as sole ration; not to be fed to (vii) Amount per ton. Pyrantel tar- swine that weigh more than 250 pounds; trate, 96 grams (0.0106 percent) and lin- withdraw 6 days before slaughter. Con- comycin, 40 grams, as lincomycin hy- sult your veterinarian before feeding to drochloride monohydrate. severely debilitated animals and for as- (A) Indications for use. For control of sistance in the diagnosis, treatment, swine dysentery; aid in the prevention and control of parasitism. of migration and establishment of (x) Amount per ton. Pyrantel tartrate, large roundworm (Ascaris suum) infec- 96 grams (0.0106 percent) and linco- tions; aid in the prevention of estab- mycin, 100 or 40 grams. lishment of nodular worm (A) Indications for use. For treatment (Oesophagostomum spp.) infections. and/or control of swine dysentery; for (B) Limitations. Feed as sole ration; removal and control of large for use in swine on premises with a his- roundworm (Ascaris suum) infections. tory of swine dysentery but where (B) Limitations. Administer in accord- symptoms have not yet occurred; not ance with paragraph (c)(2)(i), (c)(2)(ii), to be fed to swine that weigh more or (c)(2)(iii) of § 558.325 and paragraph than 250 pounds; withdraw 6 days be- (e)(1)(ii)(B) of this section. fore slaughter. Consult your veteri- (xi) Amount per ton. Pyrantel tar- narian before feeding to severely de- trate, 800 grams (0.0881 percent) and bilitated animals and for assistance in lincomycin, 100 or 40 grams. the diagnosis, treatment, and control (A) Indications for use. For treatment of parasitism. and/or control of swine dysentery; for (viii) Amount per ton. Pyrantel tar- removal and control of large trate, 96 grams (0.0106 percent) and lin- roundworm (Ascaris suum) and nodular comycin, 100 grams, then 40 grams, as worm (Oesophagostomum spp.) infec- lincomycin hydrochloride tions. monohydrate. (B) Limitations. Administer in accord- (A) Indications for use. For treatment ance with paragraph (c)(2)(i), (c)(2)(ii), and control of swine dysentery; aid in or (c)(2)(iii) of § 558.325 and paragraph the prevention of migration and estab- (e)(1)(iii)(B) of this section. lishment of large roundworm (Ascaris (xii) Amount per ton. Pyrantel tar- suum) infections; aid in the prevention trate, 96 grams (0.0106 percent) and lin- of establishment of nodular worm comycin, 200 grams as lincomycin hy- (Oesophagostomum spp.) infections. drochloride monohydrate. (B) Limitations. Feed 100 grams per (A) Indications for use. For the reduc- ton for 3 weeks or until signs of disease tion in severity of swine mycoplasma disappear, followed by 40 grams per pneumonia caused by Mycoplasma

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hyopneumoniae; aid in the prevention of Sections Affected, which appears in the migration and establishment of large Finding Aids section of the printed volume roundworms (Ascaris suum) infections; and at www.fdsys.gov. aid in the prevention of establishment § 558.500 Ractopamine. of nodular worm (Oesophagostomum spp.) infections. (a) Specifications. Type A medicated (B) Limitations. Feed as sole ration articles containing 9 or 45.4 grams of for 21 days; not to be fed to swine that ractopamine hydrochloride per pound. weigh more than 250 pounds; withdraw (b) Approvals. See Nos. 000986 and 6 days before slaughter; consult your 054771 in § 510.600(c) of this chapter. veterinarian before feeding to severely (c) Related tolerances. See § 556.570 of debilitated animals and for assistance this chapter. in the diagnosis, treatment, and con- (d) Special considerations. (1) Labeling trol of parasitism. of Type B and Type C feeds shall bear (C) Sponsor. See No. 054771 in the following: ‘‘Not for animals in- § 510.600(c) of this chapter. tended for breeding.’’ (2) Horses—(i) Amount. Feed continu- (2) Labeling of Type B and Type C ously at the rate of 1.2 milligrams per swine feeds shall bear the following: pound (2.64 milligrams per kilogram) of (i) ‘‘No increased benefit has been body weight. shown when ractopamine concentra- (A) Indications for use. Prevention of tions in the diet are greater than 4.5 g/ Strongylus vulgaris larval infections; ton.’’ control of adult large strongyles (S. (ii) ‘‘Ractopamine may increase the vulgaris, and S. edentatus), adult and number of injured and/or fatigued pigs 4th stage larvae small strongyles during marketing.’’ (Cyathostomum spp., Cylicocyclus spp., (3) Labeling of Type B and Type C Cylicostephanus spp., Cylicodontophorus tom turkey feeds shall bear the fol- spp., Poteriostomum spp., and lowing: ‘‘No increased benefit has been Triodontophorus spp.), adult and 4th shown when ractopamine concentra- stage larvae pinworms (Oxyuris equi), tions in the diet are greater than 4.6 g/ and adult and 4th stage larvae ascarids ton.’’ (Parascaris equorum). (4) Tylosin in combinations as (B) Limitations. Administer either as tylosin phosphate. a top-dress (not to exceed 20,000 grams (5) Ractopamine liquid Type B cattle per ton) or mixed in the horse’s daily feeds may be manufactured from dry grain ration (not to exceed 1,200 grams ractopamine Type A articles. The liq- per ton) during the time that the ani- uid Type B feeds must be maintained mal is at risk of exposure to internal at a pH of 4.5 to 7.5 or, if in combina- parasites. Not for use in horses in- tion with monensin and/or tylosin, at a tended for food. Consult your veteri- pH of 4.5 to 6.0. Mixing directions for narian before using in severely debili- liquid Type B feeds requiring recircula- tated animals and for assistance in the tion or agitation: Recirculate imme- diagnosis, treatment, and control of diately prior to use for not less than 10 parasitism. minutes, moving not less than 1 per- (ii) [Reserved] cent of the tank contents per minute from the bottom of the tank to the top. [40 FR 13959, Mar. 27, 1975] Recirculate daily as described even EDITORIAL NOTE: For FEDERAL REGISTER ci- when not used. tations affecting § 558.485, see the List of CFR (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- 000986, 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.

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

(ii) 4.5 to 9.0 ...... Tylosin ...... Finishing swine: As in paragraph Feed 100 grams per tons (g/ 000986 40 or 100 ...... (e)(1)(i) of this section; and for con- ton) continuously as sole ra- trol of swine dysentery associated tion for at least 3 weeks fol- with Brachyspira hyodysenteriae lowed by 40 g/ton until mar- and porcine proliferative ket weight.. enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.. (iii) 4.5 to 9.0 ...... Tylosin ...... Finishing swine: As in paragraph Feed continuously as sole ra- 000986 100 ...... (e)(1)(i) of this section; and for con- tion for 21 days.. trol of porcine proliferative enteropathies (PPE, ileitis) associated with L. intracellularis.. (iv) 4.5 to 9.0 ...... Tylosin ...... Finishing swine: As in paragraph Feed continuously as sole ra- 000986 40 to 100 ...... (e)(1)(i) of this section; for treat- tion for 2 to 6 weeks, imme- ment and control of swine dys- diately after treatment with entery associated with B. tylosin tartrate in drinking hyodysenteriae and for control of water as in § 520.2640(d)(3) porcine proliferative enteropathies of this chapter.. (PPE, ileitis) associated with L. intracellularis..

(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- 000986, 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 000986 provide 0.14 to ter: As in paragraph (e)(2)(i) of this section; see paragraph 0.42 mg section; for prevention and control §§ 558.355(d) of this chapter.. monensin/lb of of coccidiosis due to Eimeria bovis body weight, de- and E zuernii.. pending on severity of coccidiosis challenge, up to 480 mg/head/day. (iii) [Reserved]. (iv) 8.2 to 24.6 .... Monensin 10 to 40 to Cattle fed in confinement for slaugh- As in paragraph (e)(2)(i) of this 000986, provide 0.14 to ter: As in paragraph (e)(2)(i) of this section; see §§ 558.355(d) 054771 0.42 mg section; for prevention and control and 558.625(c) of this chap- monensin/lb of of coccidiosis due to Eimeria bovis ter.. body weight, de- and E. zuernii; and for reduction of pending on sever- incidence of liver abscesses caused ity of coccidiosis by Fusobacterium necrophorum challenge, up to and Arcanobacterium 480 mg/head/day, (Actinomyces) pyogenes.. plus tylosin 8 to 10. (v) [Reserved]. (vi) 9.8 to 24.6 ...... Cattle fed in confinement for slaugh- Feed continuously as sole ra- 000986 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 000986 provide 0.14 to ter: As in paragraph (e)(2)(vi) of this this section; see paragraph 0.42 mg section; for prevention and control §§ 558.355(d) of this chapter.. monensin/lb of of coccidiosis due to Eimeria bovis body weight, de- and E zuernii.. pending on severity of coccidiosis challenge, up to 480 mg/head/day.

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

(viii) 9.8 to 24.6 .. Monensin 10 to 40 to Heifers fed in confinement for slaugh- As in paragraph (e)(2)(vi) of 000986 provide 0.14 to ter: As in paragraph (e)(2)(vi) of this this section; see 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 No. pending on sever- of estrus (heat).. 054771 or 021641 in ity of coccidiosis § 510.600(c) of this chapter.. challenge, up to 480 mg/head/day, plus melengestrol acetate to provide 0.25 to 0.5 mg/ head/day. (ix) 9.8 to 24.6 .... Monensin 10 to 40 to Cattle fed in confinement for slaugh- As in paragraph (e)(2)(vi) of 000986 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 §§ 558.355(d) and 558.625(c) monensin/lb of of coccidiosis due to Eimeria bovis of this chapter.. body weight, de- and E. zuernii; and for reduction of pending on sever- incidence of liver abscesses caused ity of coccidiosis by Fusobacterium necrophorum challenge, up to and Arcanobacterium 480 mg/head/day, (Actinomyces) pyogenes.. plus tylosin 8 to 10. (x) 9.8 to 24.6 ..... Monensin 10 to 40 to Heifers fed in confinement for slaugh- As in paragraph (e)(2)(vi) of 000986 provide 0.14 to ter: As in paragraph (e)(2)(vi) of this this section; see paragraphs 0.42 mg section; for prevention and control §§ 558.342(d), 558.355(d) monensin/lb of of coccidiosis due to Eimeria bovis and 558.625(c) of this chap- body weight, de- and E. zuernii; for reduction of inci- ter. Melengestrol acetate as pending on sever- dence of liver abscesses caused by provided by Nos. 054771 and ity of coccidiosis Fusobacterium necrophorum and 021641 in § 510.600(c) of this challenge, up to Arcanobacterium (Actinomyces) chapter.. 480 mg/head/day, pyogenes; and for suppression of plus tylosin 8 to estrus (heat).. 10, plus melengestrol acetate to provide 0.25 to 0.5 mg/ head/day. (xi) Not to exceed ...... Cattle fed in confinement for slaugh- Top dress in a minimum of 1.0 000986, 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 000986 ceed 800; to provide 0.14 to ter: As in paragraph (e)(2)(i) of this minimum of 1.0 lb of medi- 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 challenge, up to 480 mg/head/day.. (xiii) Not to ex- Monensin 10 to 40 to Cattle fed in confinement for slaugh- Top dress ractopamine in a 000986 ceed 800; to provide 0.14 to ter: As in paragraph (e)(2)(i) of this minimum of 1.0 lb of medi- 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; and for reduction of animals intended for breed- pending on sever- incidence of liver abscesses caused ing. See §§ 558.355(d) and ity of coccidiosis by Fusobacterium necrophorum 558.625(c).. challenge, up to and Arcanobacterium 480 mg/head/day, (Actinomyces) pyogenes.. plus tylosin 8 to 10..

(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- 000986 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- 000986 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- 000986 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- 000986 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)..

[67 FR 71820, Dec. 3, 2002, as amended at 68 FR 54659, Sept. 18, 2003; 69 FR 12068, Mar. 15, 2004; 69 FR 51174, Aug. 18, 2004; 71 FR 31074, June 1, 2006; 71 FR 67301, Nov. 21, 2006; 72 FR 10358, Mar. 8, 2007; 72 FR 41619, July 31, 2007; 72 FR 56897, Oct. 5, 2007; 72 FR 62571, Nov. 6, 2007; 72 FR 65667, Nov. 23, 2007; 72 FR 70777, Dec. 13, 2007; 73 FR 72715, Dec. 1, 2008; 73 FR 75323, Dec. 11, 2008; 74 FR 66914, Dec. 17, 2009; 75 FR 1276, Jan. 11, 2010; 75 FR 5888, Feb. 5, 2010; 75 FR 20917, Apr. 22, 2010; 75 FR 54018, Sept. 3, 2010; 77 FR 31724, May 30, 2012; 78 FR 63872, Oct. 25, 2013; 79 FR 13546, Mar. 11, 2014]

§ 558.515 Robenidine. date of manufacture. Do not use in (a) Approvals. Type A medicated arti- Type B or Type C medicated feeds con- cles: 30 grams per pound to 054771 in taining bentonite. § 510.600(c) of this chapter. (c) Related tolerances. See § 556.580 of (b) Special considerations. Type C feed this chapter. containing robenidine hydrochloride (d) Conditions of use. It is used in feed must be fed within 50 days from the for chickens as follows:

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

30 (0.0033 pct) ...... For broiler and fryer chickens: As an Feed continuously as sole ra- 054771 aid in the prevention of coccidiosis tion. Do not feed to layers. caused by E. mivati, E. brunetti, E. Withdraw 5 days prior to tenella, E. acervulina, E. maxima, slaughter.. and E. necatrix...... Bacitracin (as baci- For broiler and fryer chickens: As an Feed continuously as sole ra- 054771 tracin methylene aid in the prevention of coccidiosis tion. Do not feed to laying disalicylate) 4 to caused by E. mivati, E. brunetti, E. chickens. Withdraw 5 days 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 methylene aid in the prevention of coccidiosis tion. Do not feed to laying disalicylate) 27 to caused by E. mivati, E. brunetti, E. chickens. Withdraw 5 days 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 methylene aid in the prevention of necrotic en- tion. Do not feed to laying disalicylate) 50. teritis caused or complicated by hens. Withdraw 5 days be- 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 methylene aid in the control of necrotic enter- outbreak, start medication at disalicylate) 100 to itis caused or complicated by Clos- first clinical signs of disease; 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 methylene disalicylate to prevention level (50 g/ton). Do not feed to laying hens. Withdraw 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...... Chlortetracycline 100 For broiler and fryer chickens: As an Feed continuously as sole ra- to 200. aid in the prevention of coccidiosis tion up to 14 days. Do not caused by E. mivati, E. brunetti, E. feed to chickens producing tenella, E. acervulina, E. maxima, eggs for human consump- and E. necatrix. For control of infection. Withdraw 5 days prior to tious synovitis caused by Myco- slaughter.. plasma synoviae susceptible to chlortetracycline...... Chlortetracycline 200 For broiler and fryer chickens: As an Feed continuously as sole ra- to 400. aid in the prevention of coccidiosis tion up to 14 days. Do not caused by E. mivati, E. brunetti, E. feed to chickens producing tenella, E. acervulina, E. maxima, eggs for human consump- and E. necatrix. For control of tion. Withdraw 5 days prior to chronic respiratory disease (CRD) slaughter.. and air sac infection caused by M. gallisepticum and E. coli susceptible to chlortetracycline...... Chlortetracycline 500 For broiler and fryer chickens: As an Feed continuously as sole ra- 054771 aid in the prevention of coccidiosis tion up to 5 days. Do not caused by E. mivati, E. brunetti, E. feed to chickens producing tenella, E. acervulina, E. maxima, eggs for human consump- and E. necatrix. As an aid in the re- tion. Withdraw 5 days prior to duction of mortality due to E. coli slaughter.. susceptible to chlortetracycline...... Lincomycin 2 ...... For broiler and fryer chickens: As an Feed continuously as the sole 054771 aid in the prevention of coccidiosis ration. Do not feed to laying caused by E. mivati, E. brunetti, E. hens. Withdraw 5 days be- tenella, E. acervulina, E. maxima, fore slaughter.. and E. necatrix. For increase in rate of weight gain and improved feed efficiency...... Oxytetracycline 400 For broiler chickens: As an aid in the Feed continuously for 7 to 14 066104 prevention of coccidiosis caused by days. Do not feed to chick- E. mivati, E. brunetti, E. tenella, E. ens producing eggs for acervulina, E. maxima, and E. human consumption. With- necatrix. For control of CRD and air draw 5 days before slaugh- sac infection caused by Myco- ter.. plasma gallisepticum and E. coli susceptible to oxytetracycline..

[40 FR 13959, Mar. 27, 1975]

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EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 558.515, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§ 558.550 Salinomycin. tenella, E. necatrix, E. acervulina, E. (a) Specifications. Type A medicated maxima, E. brunetti, and E. mivati, and articles containing 30 or 60 grams of for improved feed efficiency. salinomycin activity per pound (as (c) Limitations. Feed continuously as salinomycin sodium biomass). sole ration. Not approved for use with (b) Approvals. See sponsors in pellet binders. Do not feed to layers. § 510.600(c) of this chapter for use as in May be fatal if accidentally fed to paragraph (d) of this section: adult turkeys or horses. Bacitracin MD (1) No. 054771 for use as in paragraph as provided by No. 054771 in § 510.600(c) (d) of this section. of this chapter. (2) No. 016592 for use as in paragraphs (vii)(a) Amount per ton. Salinomycin (d)(1)(i), (d)(1)(iii) through (d)(1)(xvi), 40 to 60 grams and bacitracin zinc 10 to (d)(1)(xxiii) and (d)(1)(xxiv), (d)(2)(i), 50 grams. (d)(3)(i), and (d)(4) of this section. (b) Indications for use. For the preven- (3) No. 048164 for use as in paragraphs tion of coccidiosis caused by Eimeria (d)(1)(xv) and (d)(1)(xvi) of this section. tenella, E. necatrix, E. acervulina, E. (c) [Reserved] maxima, E. brunetti, and E. mivati, and (d) Conditions of use. (1) Broilers: It is for increased rate of weight gain. used as follows: (c) Limitations. Feed continuously as (i)(a) Amount per ton. Salinomycin 40 sole ration. Not approved for use with to 60 grams. pellet binders. Do not feed to layers. (b) Indications for use. For the preven- May be fatal if accidentally fed to tion of coccidiosis caused by Eimeria adult turkeys or horses. Bacitracin tenella, E. necatrix, E. acervulina, E. zinc as provided by No. 054771 in maxima, E. brunetti, and E. mivati. § 510.600(c) of this chapter. (c) Limitations. Feed continuously as (viii)–(ix) [Reserved] sole ration. Do not feed to laying hens (x)(a) Amount per ton. Salinomycin 40 producing eggs for human consump- to 60 grams and virginiamycin 5 grams. tion. Not approved for use with pellet (b) Indications for use. For the preven- binders. May be fatal if accidentally tion of coccidiosis caused by Eimeria fed to adult turkeys or horses. tenella, E. necatrix, E. acervulina, E. (ii) [Reserved] maxima, E. brunetti, and E. mivati, and (iii)(a) Amount per ton. Salinomycin for increased rate of weight gain and 40 to 60 grams and bacitracin meth- improved feed efficiency. ylene disalicylate 4 to 30 grams. ( ) Feed continuously as (b) Indications for use. For the preven- c Limitations. tion of coccidiosis caused by Eimeria sole ration. Not approved for use with tenella, E. necatrix, E. acervulina, E. pellet binders. Do not feed to layers or maxima, E. brunetti, and E. mivati for to chickens over 16 weeks of age. May incresed rate of weight gain and im- be fatal if accidentally fed to adult tur- proved feed efficiency. keys or horses. Virginiamycin as pro- (c) Limitation. Feed continuously as vided by No. 066104 in § 510.600(c) of this sole ration. Not approved for use with chapter. pellet binders. Do not feed to layers. (xi)(a) Amount per ton. Salinomycin May be fatal if accidentially fed to 40 to 60 grams and virginiamycin 5 to adult turkeys or horses. Bacitracin 15 grams. methylene disalicylate as provided by (b) Indications for use. For the preven- No. 054771 in § 510.600(c) of this chapter. tion of coccidiosis caused by Eimeria (iv)–(v) [Reserved] tenella, E. necatrix, E. acervulina, E. (vi)(a) Amount per ton. Salinomycin maxima, E. brunetti, and E. mivati, and 40 to 60 grams and bacitracin meth- for increased rate of weight gain. ylene disalicylate 4 to 50 grams. (c) Limitations. See paragraph (b) Indications for use. For the preven- (d)(1)(x)(c) of this section. tion of coccidiosis caused by Eimeria (xii) [Reserved]

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(xiii)(a) Amount per ton. Salinomycin ylene disalicylate as provided by 054771 40 to 60 grams and lincomycin 2 to 4 in § 510.600(c) in this chapter. grams. (xxi)(A) Amount per ton. Salinomycin, (b) Indications for use. For the preven- 40 to 60 grams; and bacitracin meth- tion of coccidiosis caused by Eimeria ylene disalicylate, 100 to 200 grams. tenella, E. necatrix, E. acervulina, E. (B) Indications for use. For the pre- maxima, E. brunetti, and E. mivati and vention of coccidiosis caused by Eimeria for improved feed efficiency. tenella, E. necatrix, E. acervulina, E. (c) Limitations. Feed continuously as maxima, E. brunetti, and E. mivati, and sole ration. Not approved for use with as an aid in the control of necrotic en- pellet binders. Do not feed to layers. teritis caused or complicated by Clos- Do not allow horses, adult turkeys, tridium spp. or other organisms suscep- guinea pigs, rabbits, hamsters, or tible to bacitracin. ruminants access to this feed. Inges- (C) Limitations. Feed continuously as tion by these species may result in se- sole ration. To control necrotic enter- vere gastrointestinal effects or may be itis, start medication at first clinical fatal. Lincomycin hydrochloride signs of disease; vary dosage based on monohydrate as provided by No. 054771 the severity of infection; administer in § 510.600(c) of this chapter. continuously for 5 to 7 days or as long (xiv)–(xv) [Reserved] as clinical signs persist, then reduce bacitracin to prevention level (50 (xvi)(a) Amount per ton. Salinomycin grams per ton). Do not feed to laying 40 to 60 grams and chlortetracycline 500 chickens. May be fatal if fed to adult grams. turkeys or to horses. Salinomycin as ( ) For the preven- b Indications for use. provided by 054771; bacitracin meth- tion of coccidiosis caused by Eimeria ylene disalicylate as provided by 054771 tenella, E., necatrix, E. acervulina, E. in § 510.600(c) in this chapter. maxima, E. brunetti, and E. mivati, and (xxii) Amount per ton. Salinomycin, 40 as an aid in the reduction of mortality to 60 grams; plus tylosin, 4 to 50 grams. due to infections susceptible to E. coli (A) Indications for use. As an aid in such treatment. the prevention of coccidiosis caused by (c) Limitations. Do not feed to layers. Eimeria tenella, E. necatrix, E. In feeds containing 0.8 percent dietary acervulina, E. maxima, E. brunetti, and calcium. Not to be fed for more than 5 E. mivati, and for increased rate of days. Not approved for use with pellet weight gain and improved feed effi- binders. Withdraw 24 hours before ciency. slaughter. May be fatal if accidentally (B) Limitations. For broiler chickens fed to adult turkeys or horses. Chlor- only. Feed continuously as sole ration. tetracycline as provided by Nos. 054771 Do not feed to laying hens. Not ap- and 048164; salinomycin as provided by proved for use with pellet binders. May Nos. 054771 and 016592 in § 510.600(c) of be fatal if accidentally fed to adult tur- this chapter. keys or horses. Salinomycin as pro- (xvii)–(xix) [Reserved] vided by 054771; tylosin phosphate as (xx)(A) Amount per ton. Salinomycin, provided by 000986 in § 510.600(c) of this 40 to 60 grams; and bacitracin meth- chapter. ylene disalicylate, 50 grams. (xxiii) Amount per ton. Salinomycin, (B) Indications for use. For the pre- 40 to 60 grams; plus bambermycins, 1 to vention 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 as an aid in the prevention of necrotic caused by Eimeria tenella, E. necatrix, E. enteritis caused or complicated by acervulina, E. maxima, E. brunetti, and Clostridium spp. or other organisms sus- E. mivati; and for improved feed effi- ceptible to bacitracin. ciency. (C) Limitations. Feed continuously as (b) Limitations. Feed continuously as sole ration. Do not feed to laying sole ration. Do not feed to laying chickens. May be fatal if fed to adult chickens; not approved for use with turkeys or to horses. Salinomycin as pellet binders; may be fatal if acciden- provided by 054771; bacitracin meth- tally fed to adult turkeys or horses.

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Salinomycin as provided by Nos. 054771 (B) Limitations. Feed continuously as and 016592; bambermycins by No. 016592 sole ration. Discontinue use prior to in § 510.600(c) of this chapter. sexual maturity. Do not feed to laying (xxiv) [Reserved] chickens. May be fatal if fed to adult (2) Quail—(i)(a) Amount per ton. turkeys or to horses. Salinomycin as Salinomycin 50 grams. provided by 054771; bacitracin meth- (b) Indications for use. For the preven- ylene disalicylate as provided by 054771 tion of coccidiosis caused by E. dispersa in § 510.600(c) of this chapter. and E. lettyae. (iv) [Reserved] (c) Limitations. Feed continuously as (v) Amount per ton. Salinomycin, 40 to sole ration. Not approved for use with 60 grams, and bacitracin methylene di- pellet binders. May be fatal if acciden- salicylate, 100 to 200 grams. tally fed to adult turkeys or horses. Do (A) Indications for use. For the pre- not feed to laying hens producing eggs vention of coccidiosis caused by Eimeria for human consumption. tenella, E. necatrix, E. acervulina, E. (ii) [Reserved] maxima, E. brunetti, and E. mivati, and (3) Roaster and replacement (breeder as an aid in the control of necrotic en- and layer) chickens: It is used as fol- teritis caused or complicated by Clos- lows: tridium spp. or other organisms suscep- (i)(A) Amount per ton. Salinomycin 40 tible to bacitracin. to 60 grams. (B) Limitations. Feed continuously as (B) Indications for use. For prevention sole ration. To control necrotic enter- of coccidiosis caused by Eimeria tenella, itis, start medication at first clinical E. necatrix, E. acervulina, E. maxima, E. signs of disease; vary dosage based on brunetti, and E. mivati. the severity of infection; administer (C) Limitations. Feed continuously as continuously for 5 to 7 days or as long sole ration. Do not feed to laying hens as clinical signs persist, then reduce producing eggs for human consump- bacitracin to prevention level (50 tion. Not approved for use with pellet grams per ton). Discontinue use prior binders. May be fatal if accidentally to sexual maturity. Do not feed to lay- fed to horses or adult turkeys. ing chickens. May be fatal if fed to (ii) Amount per ton. Salinomycin, 40 adult turkeys or to horses. to 60 grams, and bacitracin methylene Salinomycin as provided by 054771 ; disalicylate, 4 to 50 grams. bacitracin methylene disalicylate as (A) Indications for use. For the pre- provided by 054771 in § 510.600(c) of this vention of coccidiosis caused by Eimeria chapter. tenella, E. necatrix, E. acervulina, E. (vi)–(vii) [Reserved] maxima, E. brunetti, and E. mivati, and (4) Chickens: It is used in chicken feed for increased rate of weight gain and as follows: improved feed efficiency. (i) Amount per ton. Salinomycin, 40 to (B) Limitations. Feed continuously as 60 grams; plus oxytetracycline, 500 sole ration. Discontinue use prior to grams. sexual maturity. Do not feed to laying (a) Indications for use. For prevention chickens. May be fatal if fed to adult of coccidiosis caused by Eimeria tenella, turkeys or to horses. Salinomycin as E. necatrix, E. acervulina, E. maxima, E. provided by 054771; bacitracin meth- brunetti, and E. mivati; and for reduc- ylene disalicylate as provided by 054771 tion of mortality due to air sacculitis in § 510.600(c) of this chapter. (air-sac-infection) caused by Esch- (iii) Amount per ton. Salinomycin, 40 erichia coli susceptible to oxytetra- to 60 grams, and bacitracin methylene cycline. disalicylate, 50 grams. (b) Limitations. Feed continuously for (A) Indications for use. For the pre- 5 days; do not feed to chickens pro- vention of coccidiosis caused by Eimeria ducing eggs for human consumption; tenella, E. necatrix, E. acervulina, E. withdraw 24 hours before slaughter; in maxima, E. brunetti, and E. mivati, and low calcium feeds withdraw 3 d before as an aid in the prevention of necrotic slaughter. Salinomycin as provided by enteritis caused or complicated by Nos. 054771 and 016592; oxytetracycline Clostridium spp. or other organisms sus- as provided by No. 066104 in § 510.600(c) ceptible to bacitracin. of this chapter.

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(ii) [Reserved] (2) 22.7 g/lb (50 g/kg) semduramicin [48 FR 30616, July 5, 1983] (as semduramicin sodium biomass). (b) Approvals. See No. 066104 in EDITORIAL NOTE: For FEDERAL REGISTER ci- § 510.600(c) of this chapter for use of tations affecting § 558.550, see the List of CFR Sections Affected, which appears in the product described in paragraph (a)(1) as Finding Aids section of the printed volume in paragraph (d) of this section; for use and at www.fdsys.gov. of product described in paragraph (a)(2) as in paragraph (e) of this section. § 558.555 Semduramicin. (c) Related tolerances. See § 556.597 of (a) Specifications. Type A medicated this chapter. article containing: (d) Conditions of use in chickens. It is (1) 22.7 grams (g) per pound (lb) (50 g/ used in chicken feed as follows: kilogram (kg)) semduramicin (as semduramicin sodium).

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 methylene graph (d)(1) of this section; Do not feed to laying hens. disalicylate for improved feed effi- Bacitracin methylene disalicy- 10 to 50 ciency. late as provided by No. 054771 in § 510.600(c) of this chapter.

(3) 22.7 Virginiamycin 5 Broiler chickens: As in para- Feed continuously as sole ration. 066104 graph (d)(1) of this section; Do not feed to laying hens. for increased rate of Virginiamycin as provided by weight gain and improved No. 066104 in § 510.600(c) of feed efficiency. this chapter.

(4) 22.7 Virginiamycin 5 Broiler chickens: As in para- Feed continuously as sole ration. 066104 to 15 graph (d)(1) of this section; Do not feed to laying hens. for increased rate of Virginiamycin as provided by weight gain. No. 066104 in § 510.600(c) of this chapter.

(5) 22.7 Virginiamycin Broiler chickens: As in para- Feed continuously as sole ration. 066104 20 graph (d)(1) of this section; Do not feed to laying hens. for prevention of necrotic Virginiamycin as provided by enteritis caused by Clos- No. 066104 in § 510.600(c) of tridium perfringens suscep- this chapter. tible to virginiamycin.

(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) 22.7 Virginiamycin 5 Broiler chickens: As in para- Feed continuously as sole ration. 066104 graph (e)(1) of this section; Withdraw 1 day before slaugh- for increased rate of ter. Do not feed to laying hens. weight gain and improved Virginiamycin provided by No. feed efficiency. 066104 in § 510.600(c) of this chapter.

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

(3) 22.7 Virginiamycin 5 Broiler chickens: As in para- Feed continuously as sole ration. 066104 to 15 graph (e)(1) of this section; Withdraw 1 day before slaugh- for increased rate of ter. Do not feed to laying hens. weight gain. Virginiamycin provided by No. 066104 in § 510.600(c) of this chapter. (4) 22.7 Virginiamycin Broiler chickens: As in para- Feed continuously as sole ration. 066104 20 graph (e)(1) of this section; Withdraw 1 day before slaugh- for prevention of necrotic ter. Do not feed to laying hens. enteritis caused by C. Virginiamycin provided by No. perfringens susceptible to 066104 in § 510.600(c) of this virginiamycin. chapter.

[59 FR 17477, Apr. 13, 1994, as amended at 60 FR 57928, Nov. 24, 1995; 61 FR 29481, June 11, 1996; 61 FR 43451, Aug. 23, 1996; 61 FR 66584, Dec. 18, 1996; 62 FR 66985, Dec. 23, 1997; 64 FR 48296, Sept. 3, 1999; 66 FR 47964, Sept. 17, 2001; 69 FR 13221, Mar. 22, 2004; 70 FR 41961, July 21, 2005; 73 FR 812, Jan. 4, 2008; 74 FR 41631, Aug. 18, 2009; 79 FR 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, 2014]

EDITORIAL NOTE: At 79 FR 13546, Mar. 11, (2) Replacement chickens—(i) Amount 2014, § 558.555 was amended; however, the per ton. Sulfadimethoxine, 113.5 grams amendment could not be incorporated due to (0.0125 percent) plus ormetoprim, 68.1 inaccurate amendatory instruction. grams (0.0075 percent). § 558.575 Sulfadimethoxine, (ii) Indications for use. As an aid in ormetoprim. the prevention of coccidiosis caused by (a) Approvals. Type A medicated arti- all Eimeria species known to be patho- cles to sponsors as identified in genic to chickens, namely E. tenella, E. § 510.600(c) of this chapter for uses as in necatrix, E. acervulina, E. brunetti, E. paragraph (d) of this section as follows: mivati, and E. maxima, and bacterial in- (1) 25 percent sufadimethoxine and 15 fections due to H. galmaxima, and bac- percent ormetoprim to 054771 for use terial infections due to H. gallinarum for poultry as in paragraphs (d)(1), (infectious coryza), E. coli (d)(2), (d)(3), (d)(4), and (d)(7) of this (colibacillosis) and P. multocida (fowl section. cholera). (2) 25 percent sulfadimethoxine and 5 (iii) Limitations. Feed as a sole ration; percent ormetoprim to No. 015331 for do not feed to chickens over 16 weeks use for fish as in paragraphs (d)(5) and (112 days) of age; withdraw 5 days be- (d)(6) of this section. fore slaughter. (b) Related tolerances. See §§ 556.490 (3) Turkeys—(i) Amount per ton. and 556.640 of this chapter. Sulfadimethoxine, 56.75 grams (0.00625 (c) [Reserved] percent) plus ormetoprim, 34.05 grams (d) Conditions -of use. It is used in (0.00375 percent). feeds for animals as follows: (ii) Indications for use. As an aid in (1) Broiler chickens—(i) Amount per the prevention of coccidiosis caused by ton. Sulfadimethoxine, 113.5 grams all Eimeria species known to be patho- (0.0125 percent) plus ormetoprim, 68.1 genic to turkeys, namely, E. grams (0.0075 percent). adenoeides, E. gallopavonis, and E. (a) Indications for use. As an aid in the prevention of coccidiosis caused by meleagrimitis and bacterial infection all Eimeria species known to be patho- due to P. multocida (fowl cholera). genic to chickens, namely, E. tenella, E. (iii) Limitations. Do not feed to tur- necatrix, E. acervulina, E. brunetti, E. keys producing eggs for food; withdraw mivati, and E. maxima, and bacterial in- 5 days before slaughter. fections due to H. gallinarum (infec- (4) Ducks—(i) Amount per ton. tious coryza), E. coli (colibacillosis) and Sulfadimethoxine, 227 grams (0.025 per- P. multocida (fowl cholera). cent) plus ormetoprim, 136.2 grams (b) Limitations. Feed as sole ration; (0.015 percent). withdraw 5 days before slaughter. (a) Indications for use. As an aid in (ii) [Reserved] the control of bacterial infections due

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to P. multocida (fowl cholera) in ducks, (iii) Limitations. Feed continuously to including breeding ducks. young birds up to 8 weeks of age as sole (b) Limitations. Feed as sole ration for ration. 7 days; withdraw 5 days before slaugh- [40 FR 13959, Mar. 27, 1975, as amended at 42 ter; medication should be started at FR 13550, Mar. 11, 1977; 49 FR 33442, Aug. 23, the first signs of infection; do not feed 1984; 49 FR 46371, Nov. 26, 1984; 51 FR 7400, to ducks producing eggs for food. Mar. 3, 1986; 51 FR 18884, May 23, 1986; 52 FR (ii) Amount per ton. 2686, Jan. 26, 1987; 54 FR 1686, Jan. 17, 1989; 63 Sulfadimethoxine, 454 grams (0.05 per- FR 27846, May 21, 1998; 64 FR 26672, May 17, 1999; 64 FR 43910, Aug. 12, 1999; 66 FR 46707, cent) plus ormetoprim, 272.4 grams (0.03 Sept. 7, 2001; 70 FR 52292, Sept. 2, 2005; 79 FR percent). 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, 2014] (a) Indications for use. As an aid in the control of bacterial infections due § 558.582 Sulfamerazine. to E. coli, Riemerella anatipestifer, and (a) Approvals. Type A medicated arti- severe challenge of P. multocida (fowl cles: 99 percent to 054771 in § 510.600(c) cholera) in ducks. of this chapter. (b) Limitations. Feed as a sole ration (b) Related tolerances. See § 556.660 of for 7 days; withdraw 5 days before this chapter. slaughter; medication should be start- (c) Conditions of use. It is used in fish ed at the first signs of infection; not feed for rainbow trout, brook trout, for breeding ducks; do not feed to and brown trout as follows: ducks producing eggs for food. (1) Amount. 10 grams of sulfamerazine (5) Salmonids—(i) Amount. 50 milli- per 100 pounds of fish per day. grams of active ingredients per kilo- (2) Indications for use. Control of fu- gram of body weight per day. runculosis. (ii) Indications of use. For the control (3) Limitations. Treat for not more of furunculosis in salmonids (trout and than 14 days; do not treat within 3 salmon) caused by Aeromonas weeks of marketing or stocking in salmonicida strains susceptible to stream open to fishing. sulfadimethoxine and ormetoprim com- [41 FR 11005, Mar. 15, 1976, as amended at 51 bination. FR 7400, Mar. 3, 1986; 61 FR 18082, Apr. 24, (iii) Limitations. Administer for 5 con- 1996; 63 FR 27846, May 21, 1998; 66 FR 46707, secutive days; withdraw 42 days before Sept. 7, 2001; 79 FR 13546, Mar. 11, 2014] release as stocker fish or slaughter. § 558.586 Sulfaquinoxaline. (6) Catfish—(i) Amount. 50 milligrams of active ingredients per kilogram of (a) Specifications. Type A medicated body weight per day. articles containing 40 percent (ii) Indications for use. For control of sulfaquinoxaline. enteric septicemia of catfish caused by (b) Approvals. See No. 000859 in Edwardsiella ictaluri strains susceptible § 510.600(c) of this chapter. to sulfadimethoxine and ormetoprim (c) Special considerations. (1) For con- combination. trol of outbreaks of disease, medica- (iii) Limitations. Administer for 5 con- tion should be initiated as soon as the secutive days; withdraw 3 days before diagnosis is determined. Medicated chickens, turkeys, and rabbits must ac- slaughter or release as stocker fish. tually consume enough medicated feed (7) Chukar partridges—(i) Amount per which provides a recommended dose of ton. Sulfadimethoxine 113.5 grams approximately 3.5 to 60 milligrams per (0.0125 percent) plus ormetoprim 68.1 pound per day in chickens, 2.5 to 100 grams (0.0075 percent). milligrams per pound per day in tur- (ii) Indications for use. For prevention keys, and 2.8 to 68 milligrams per of coccidiosis caused by Eimeria kofoidi pound per day in rabbits depending and E. legionensis. upon age and class of animal, ambient temperature, and other factors. Con- sult a veterinarian or poultry pathologist for diagnosis. (2) [Reserved]

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(d) Conditions of use. It is used as fol- (a) Indications for use. As an aid in lows: controlling outbreaks of coccidiosis (1) Chickens—(i) Amount. 0.015 per- caused by Eimeria tenella, E. necatrix, E. cent. acervulina, E. maxima, and E. brunetti. (a) Indications for use. As an aid in (b) Limitations. Feed at 0.1 percent preventing outbreaks of coccidiosis level for first 48 to 72 hours. Skip 3 caused by Eimeria tenella, E. necatrix, E. days; 0.05 percent for 2 days, skip 3 acervulina, E. maxima, and E. brunetti days; 0.05 percent for 2 days. If bloody under average conditions of exposure. droppings recur, give 0.05 percent for (b) Limitations. Feed continuously another 2 days. Do not treat chickens from the time birds are placed on litter within 10 days of slaughter. Do not and continue past the age when coc- medicate chickens producing eggs for cidiosis is ordinarily a hazard. If death human consumption. losses exceed 0.5 percent in a 2-day pe- (2) Turkeys—(i) Amount. 0.0175 per- riod, obtain a laboratory diagnosis. If cent. coccidiosis is the cause, use the (a) Indications for use. As an aid in sulfaquinoxaline levels recommended preventing outbreaks of coccidiosis for control of outbreaks, returning to caused by Eimeria meleagrimitis and E. the original dosage schedule after the adenoeides. outbreak has subsided. Losses may re- (b) Limitations. Feed 0.0175 percent continuously during time birds are sult from intercurrent disease, other closely confined. May be continued for conditions affecting drug intake, or week to 10 days after flock is trans- variant strains of coccidia species ferred to range to reduce danger of an which can contribute to the virulence outbreak following moving of the of coccidiosis under field conditions. flock. Do not treat turkeys within 10 Do not treat chickens within 10 days of days of slaughter. Do not medicate tur- slaughter. Do not medicate chickens keys producing eggs for human con- producing eggs for human consump- sumption. tion. (ii) Amount. 0.05 percent. (ii) Amount. 0.0175 percent. (a) Indications for use. As an aid in (a) Indications for use. As an aid in controlling outbreaks of coccidiosis preventing outbreaks of coccidiosis caused by Eimeria meleagrimitis, and E. caused by Eimeria tenella, E. necatrix, E. adenoeides. acervulina, E. maxima, and E. brunetti (b) Limitations. Feed 0.05 percent for 2 where excessive exposure to coccidia is days. Follow with 3 days on regular increased due to overcrowding or other feed and 2 more days on 0.05 percent management factors. sulfaquinoxaline feed. Again follow (b) Limitations. Feed continuously with 3 days on regular feed and 2 more from the time birds are placed on litter days on 0.05 percent sulfaquinoxaline and continue past the age when coc- feed. Continue this schedule if nec- cidiosis is ordinarily a hazard. If death essary till all signs of the outbreaks losses exceed 0.5 percent in a 2-day pe- have subsided. Do not treat turkeys riod, obtain a laboratory diagnosis. If within 10 days of slaughter. Do not coccidiosis is the cause, use the medicate turkeys producing eggs for sulfaquinoxaline levels recommended human consumption. for control of outbreaks, returning to (3) Chickens and turkeys—(i) Amount. the original dosage schedule after the 0.05 or 0.1 percent. outbreak has subsided. Losses may re- (a) Indications for use. As an aid in sult from intercurrent disease, other the control of acute fowl cholera conditions affecting drug intake, or caused by Pasteurella multocida suscep- variant strains of coccidia species tible to sulfaquinoxaline and fowl ty- which can contribute to the virulence phoid caused by Salmonella gallinarum of coccidiosis under field conditions. susceptible to sulfaquinoxaline. Do not treat chickens within 10 days of (b) Limitations. Feed 0.1 percent for 48 slaughter. Do not medicate chickens to 72 hours. Mortality should be producing eggs for human consump- brought under control. After medication. tion, move birds to clean ground or to (iii) Amount. 0.1 to 0.05 percent. a clean house. If disease recurs, use 0.05

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percent in feed again for 2 days. Do not § 558.600 Tiamulin. treat chickens or turkeys within 10 days of slaughter for food. Do not (a) Specifications. Type A article con- medicate chickens or turkeys pro- taining 363.2 grams of tiamulin hydro- ducing eggs for human consumption. gen fumarate per pound. (ii) [Reserved] (b) Approvals. See No. 058198 in (4) Rabbits—(i) Amount. 0.025 percent. § 510.600(c) of this chapter. $(a) Indications for use. As an aid in (c) Related tolerances. See § 556.738 of preventing coccidiosis caused by this chapter. Eimeria stiedae. (d) Special considerations—(1) Swine $(b) Limitations. Treatment to be being treated with tiamulin should not started after weaning. Feed continu- have access to feeds containing ously for 30 days or feed medicated feed polyether ionophores (e.g., lasalocid, for 2 days out of every week until mar- monensin, narasin, salinomycin, or keting. Do not treat within 10 days of semduramycin) as adverse reactions slaughter. may occur. If signs of toxicity occur, (ii) Amount. 0.1 percent. discontinue use. (a) Indications for use. As an aid in controlling outbreaks of coccidiosis (2) The effects of tiamulin on swine caused by Eimeria stiedae. reproductive performance, pregnancy, $(b) Limitations. Feed for 2 weeks. Do and lactation have not been deter- not treat within 10 days of slaughter. mined. (3) Use as sole source of tiamulin. [48 FR 3965, Jan. 28, 1983, as amended at 51 FR 7400, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; (e) Conditions of use—(1) Swine. It is 55 FR 29843, July 23, 1990; 59 FR 33197, June used as follows: 28, 1994; 69 FR 60547, Oct. 12, 2004; 78 FR 17597, Mar. 22, 2013]

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

(i) [Reserved] ...... (ii) 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. (iii) 35 ...... Chlortetracycline, approxi- For treatment of swine bacterial Feed continuously as sole ra- 048164, mately 400 (varying with enteritis caused by Escherichia tion for 14 days. Use as 058198 body weight and feed coli and Salmonella choleraesuis only source of chlortetra- consumption to provide and bacterial pneumonia caused cycline. Withdraw 2 days 10 milligrams of chlor- by Pasteurella multocida sen- before slaughter. tetracycline per pound of sitive to chlortetracycline, and As chlortetracycline calcium body weight daily). control of swine dysentery asso- complex, Type A medi- ciated with Brachyspira (formerly cated articles containing Serpulina or Treponema) the equivalent of 50 to 100 hyodysenteriae sensitiveto grams per pound of chlor- tiamulin. tetracycline hydrochloride provided by 054771 and 048164 in § 510.600(c) of this chapter. Use as only source of tiamulin. (iv) 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.

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(2) [Reserved] (ii) Indications for use. Control of severe infections of gastrointestinal [67 FR 7268, Feb. 19, 2002, as amended at 69 FR 62407, Oct. 26, 2004; 70 FR 75018, Dec. 19, roundworms (Trichostrongylus spp., 2005; 74 FR 6, Jan. 2, 2009; 77 FR 24139, Apr. 23, Haemonchus spp., Ostertagia spp., 2012; 79 FR 13546, Mar. 11, 2014] Cooperia spp., Nematodirus spp., Bunostomum spp., Strongyloides spp., § 558.615 Thiabendazole. Chabertia spp., and Oesophagostomum (a) Approvals. Dry Type A medicated spp. ). articles: 22, 44.1, 66.1, and 88.2 percent (iii) Limitations. 3 grams per 100 lb. to 050604 in § 510.600(c) of this chapter. body weight at a single dose; do not The 66.1 percent Type A is solely for treat animals within 30 days of slaugh- the manufacture of cane molasses liq- ter; milk taken from treated animals uid Type B feed which is mixed in dry within 96 hours (8 milkings) after the feeds. The 88.2 percent Type A is used latest treatment must not be used for solely for the manufacture of an aque- food. ous slurry for adding to a Type C dry (3) Sheep and goats—(i) Amount. 2 cattle feed. grams per 100 lb. body weight. (b) Special considerations. Do not use (ii) Indications for use. Control of in- in Type B or Type C medicated feed fections of gastrointestinal containing bentonite. roundworms (Trichostrongylus spp., (c) Related tolerances. See § 556.730 of Haemonchus spp., Ostertagia spp., this chapter. Cooperia spp.; Nematodirus spp., (d) Conditions of use. It is used in feed Bunostomum spp., Strongyloides spp., for animals as follows: Chabertia spp., and Oesophagostomum (1) Cattle—(i) Amount. 3 grams per 100 spp. ); also active against ova and lar- lb. body weight. vae passed by sheep from 3 hours to 3 (a) Indications for use. Control of in- days after the feed is consumed (good fections of gastrointestinal activity against ova and larvae of T. roundworms (Trichostrongylus spp., colubriformis and axei, Ostertagia spp., Haemonchus spp., Ostertagia spp., Nematodirus spp., Strongyloides spp.; less Nematodirus spp., Oesophagostomum effective against those of Haemonchus radiatum). contortus and Oesophagostomum spp. ). (b) Limitations. Use 3 grams per 100 lb. (iii) Limitations. Use 2 grams per 100 body weight at a single dose; may re- lb. body weight at a single dose; do not peat once in 2 to 3 weeks; do not treat treat animals within 30 days of slaugh- animals within 3 days of slaughter; ter; milk taken from treated animals milk taken from treated animals with- within 96 hours (8 milkings) after the in 96 hours (8 milkings) after the latest latest treatment must not be used for treatment must not be used for food. food. (ii) Amount. 5 grams per 100 lb. body (4) For swine—(i) Amount. 45.4–908 weight. grams per ton (0.005–0.1 percent). (a) Indications for use. Control of se- (ii) Indications for use. Aid in the pre- vere infections of gastrointestinal vention of infections of large roundworms (Trichostrongylus spp., roundworms (genus Ascaris). Haemonchus spp., Ostertagia spp., (iii) Limitations. Administer continu- Nematodirus spp., Oesophagostomum ously feed containing 0.05–0.1 percent radiatum); control of infections of thiabendazole per ton for 2 weeks fol- Cooperia spp. lowed by feed containing 0.005–0.02 per- (b) Limitations. 5 grams per 100 lb. cent thiabendazole per ton for 8–14 body weight at a single dose or divided weeks; do not treat animals within 30 into 3 equal doses, administered 1 dose days of slaughter. each day, on succeeding days; may re- (5) Pheasants—(i) Amount. 454 grams peat once in 2 to 3 weeks; do not treat per ton (0.05 percent) continuously for 2 animals within 3 days of slaughter; weeks (14 days). milk taken from treated animals with- (ii) Indications for use. For the treat- in 96 hours (8 milkings) after the latest ment of gapeworms (Syngamus trachea) treatment must not be used for food. in pheasants. (2) Goats—(i) Amount. 3 grams per 100 (iii) Limitations. Do not use treated lb. body weight. pheasants for food for 21 days after last

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day of treatment. Fertility, hatch- during each phase of production with- ability, and other reproductive data out ceasing administration for reevalu- are not available on use in breeding ation of antimicrobial use by a licensed animals. veterinarian before reinitiating a fur- [40 FR 13959, Mar. 27, 1975, as amended at 47 ther course of therapy with an appro- FR 49641, Nov. 2, 1982; 49 FR 29958, July 25, priate antimicrobial. 1984; 51 FR 7400, Mar. 3, 1986; 52 FR 2686, Jan. (5) Special consideration for use of 26, 1987; 62 FR 63271, Nov. 28, 1997] tilmicosin medicated cattle feeds include the following: § 558.618 Tilmicosin. (i) The expiration date of VFDs for (a) Specifications. Type A medicated cattle must not exceed 45 days from article containing 90.7 grams (g) per the time of issuance. pound tilmicosin as tilmicosin phos- (ii) Labeling of tilmicosin Type B or phate (200 g per kilogram). Type C medicated feeds for cattle must (b) Approvals. See Nos. 000986 and bear the following warning: ‘‘Do not 016592 in § 510.600(c) of this chapter. use in any feeds containing bentonite, (c) Special considerations—(1) cottonseed meal, or cottonseed hulls. Tilmicosin medicated feeds are re- Bentonite, cottonseed meal, or cotton- stricted to use under a veterinary feed seed hulls in feeds may affect the effi- directive (VFD). See § 558.6 of this chap- cacy of tilmicosin.’’ ter for required label statements and (iii) To assure both food safety and other limitations. responsible use in cattle, administra- (2) VFDs for tilmicosin phosphate tion of feed containing tilmicosin to shall not be refilled. cattle experiencing an outbreak of (3) Labeling of tilmicosin Type B or BRD must be initiated during the first Type C medicated feeds must bear the 45 days of the production period, shall following warnings: not exceed a single 14-consecutive-day (i) Do not allow horses or other treatment, should not occur concur- equines access to feeds containing rent with or following administration tilmicosin. of an injectable macrolide, and should (ii) [Reserved] (4) Special considerations for use of not occur within 3 days following ad- tilmicosin medicated swine feeds in- ministration of a nonmacrolide clude the following: injectable BRD therapy. Tilmicosin (i) The expiration date of VFDs for medicated feed treatment has not been tilmicosin must not exceed 90 days evaluated in cattle with severe clinical from the time of issuance. disease. Cattle with severe clinical ill- (ii) Labeling of tilmicosin Type B or ness should be evaluated for individual Type C medicated feeds for swine must treatment with an alternative non- bear the following warning: ‘‘Do not macrolide therapy. use in any feeds containing bentonite. (d) Related tolerances. See § 556.735 of Bentonite in feeds may affect the effi- this chapter. cacy of tilmicosin.’’ (e) Conditions of use. It is used in feed (iii) Feed containing tilmicosin shall as follows: not be fed to pigs for more than 21 days (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 000986, 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] ......

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(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- 000986 dairy cattle: For the vide 12.5 mg tilmicosin/kg of body- 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- 000986 ment for slaughter: vide 12.5 mg tilmicosin/kg of body- 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. (iii) 568 to 757 ...... Monensin, 10 to 40 ... Cattle fed in confine- Feed continuously for 14 days to pro- 000986 ment for slaughter: vide 12.5 mg tilmicosin/kg of body- 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 in the group.

[61 FR 68148, Dec. 27, 1996; 62 FR 15391, Apr. 1, § 558.625 Tylosin. 1997, as amended at 64 FR 13679, Mar. 22, 1999; 65 FR 76930, Dec. 8, 2000; 67 FR 21997, May 2, (a) Specifications. Type A medicated 2002; 69 FR 78306, Dec. 30, 2004; 76 FR 76894, articles containing tylosin phosphate. Dec. 9, 2011; 77 FR 60623, Oct. 4, 2012; 78 FR (b) Approvals. Type A medicated arti- 19987, Apr. 3, 2013] cle levels of tylosin granted to firms as

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sponsor(s) and identified by drug list- (89) To 048164: 5, 10, 20, and 40 grams ing numbers in § 510.600(c) of this chap- per pound, paragraph (f)(1) (i) through ter for the specific usage indicated in (vi) of this section. paragraph (f) of this section. (90) No. 016592: 100 grams per pound (1) To 000986: 10, 40, 100 grams per for use as in paragraph (f) of this sec- pound, paragraphs (f)(1) (i) through (vi) tion. of this section. (c) Special considerations. (1) Type C (2)–(4) [Reserved] medicated feeds for cattle may be man- (5) To No. 051311: 0.4, 0.8, 1, and 8 ufactured from tylosin liquid Type B grams per pound, paragraph (f)(1)(vi)(a) medicated feeds which have a pH be- of this section; 10 and 40 grams per tween 4.5 and 6.0 and which bear appro- pound, paragraphs (f)(1) (i) through (vi) priate mixing directions as follows: of this section. (i) For liquid feeds stored in recircu- (6)–(9) [Reserved] lating tank systems: Recirculate im- (10) To No. 012286: 0.4, 0.8, and 1.6 mediately prior to use for not less than grams per pound, paragraph (f)(1)(vi)(a) 10 minutes, moving not less than 1 per- of this section; 20, 40, and 100 grams per cent of the tank contents per minute pound, paragraphs (f)(1)(i) through (vi) from the bottom of the tank to the top. of this section. Recirculate daily as described even (11)–(24) [Reserved] when not used. (25) To 066104: 4, 8, and 10 grams per (ii) For liquid feeds stored in me- pound, paragraph (f)(1)(vi)(a) of this chanical, air, or other agitation-type section; 20 and 40 grams per pound, tank systems: Agitate immediately paragraphs (f)(1) (i) through (vi) of this prior to use for not less than 10 min- section. utes, creating a turbulence at the bot- (26)–(32) [Reserved] tom of the tank that is visible at the (33) To 034936: 0.8 and 2 grams per top. Agitate daily as described even pound, paragraph (f)(1)(vi)(a) of this when not used. section; 4, 8, and 10 grams per pound, (2) Tylosin liquid Type B medicated paragraphs (f)(1)(i), (iii), (iv), and (vi) of feeds used to make Type C medicated this section; 40 grams per pound, para- feeds for cattle may be manufactured graphs (f)(1) (i) through (vi) of this sec- from tylosin Type A medicated articles tion; 100 grams per pound, paragraphs according to the following mixing di- (f)(1) (i), (ii), (iii), (iv), and (vi) of this rections: section. (i) [Reserved] (34) [Reserved] (ii) Maintain a pH between 4.5 and (35)–(38) [Reserved] 6.0. (39) To 061623: 10 grams per pound, (3) Tylosin liquid Type B medicated paragraph (f)(1)(vi)(a) of this section. feeds must bear an expiration date of 31 (40)–(47) [Reserved] days after the date of manufacture. (48) To 017790: 5, 10, 20, and 40 grams (d) [Reserved] per pound, paragraphs (f)(1) (i) through (e) Related tolerances. See § 556.740 of (vi) of this section. this chapter. (49)–(53) [Reserved] (f) Conditions of use. (1) It is used in (54) To 054771: 5, 10, 20, and 40 grams animal feeds as follows: per pound, paragraphs (f)(1) (i) through (i) For beef cattle—(a) Amount per ton. (vi) of this section. 8–10 grams. (55)–(77) [Reserved] (b) Indications for use. For reduction (78) To 050972: 0.36, 0.4, 0.72, and 0.8 of incidence of liver abscesses caused gram per pound, paragraph (f)(1)(vi)(a) by Fusobacterium necrophorum and of this section; 1 gram per pound, para- Arcanobacterium (Actinomyces) pyogenes. graphs (f)(1)(vi) (a), (b), and (d) of this (c) Limitations. As tylosin phosphate; section. each animal must receive not more (79)–(84) [Reserved] than 90 milligrams per day and not less (85) To 047126: 10, 40, and 100 grams than 60 milligrams per day; feed con- per pound, paragraphs (f)(1) (i) through tinuously as sole ration. (vi) of this section. (ii) Broiler chickens—(a) Amount per (86)–(88) [Reserved] ton. Tylosin, 800–1000 grams.

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(b) Indications for use. To aid in the (PPE, ileitis) associated with Lawsonia control of chronic respiratory disease intracellularis. caused by Mycoplasma gallisepticum. (2) Limitations. Administer as tylosin (c) Limitations. As tylosin phosphate; phosphate in feed for 2 to 6 weeks, im- withdraw 5 days before slaughter; ad- mediately after treatment with tylosin minister in feed to chickens 0 to 5 days tartrate in drinking water as in of age, follow with second administra- § 520.2640(d)(3) of this chapter. tion in feed for 24–48 hours at 3 to 5 (d) Amount per ton. Tylosin, 100 weeks of age. grams. (iii) Chickens—(a) Amount per ton. (1) Indications for use. Maintaining Tylosin, 4–50 grams. weight gains and feed efficiency in (1) Indications for use. For increased presence of atrophic rhinitis. rate of weight gain and improved feed (2) Limitations. As tylosin phosphate. efficiency. (vi) Pyrantel tartrate in accordance (2) Limitations. As tylosin phosphate. with § 558.485. (iv) Laying chickens—(a) Amount per (e) Amount per ton. Tylosin 100 grams. ton. Tylosin, 20–50 grams. (1) Indications for use. For the control (b) Indications for use. For improved of porcine proliferative enteropathies feed efficiency. (PPE, ileitis) associated with Lawsonia (c) Limitations. As tylosin phosphate. intracellularis. (v) Replacement chickens—(a) Amount (2) Limitations. As tylosin phosphate, per ton. Tylosin, 1,000 grams. administer for 21 days. (b) Indications for use. To aid in the (2) Tylosin may also be used in com- control of chronic respiratory disease bination with: caused by Mycoplasma gallisepticum. (i) Decoquinate and monensin as in (c) Limitations. As tylosin phosphate; § 558.195. withdraw 5 days before slaughter; ad- (ii) Hygromycin B as in § 558.274. minister in feed to chickens 0 to 5 days (iii) Melengestrol acetate alone or in of age, follow with second administra- combination with certain ionophores tion in feed for 24 to 48 hours at 3 to 5 as in § 558.342. weeks of age. (iv) Monensin as in § 558.355. (vi) Swine—(a) Amount per ton. (v) Narasin as in § 558.363. Tylosin, 10–100 grams. (vi) Pyrantel tartrate as in § 558.485. (1) Indications for use. For increased (vii) Ractopamine alone or in com- rate of weight gain and improved feed bination as in § 558.500. efficiency. (viii) Salinomycin as in § 558.550. (2) Limitations. As tylosin phosphate; (ix) Zilpaterol alone or in combina- continuous use as follows: Grams per tion as in § 558.665. ton: 20–100, prestarter or starter; 20–40, grower; 10–20, finisher. [40 FR 13959, Mar. 27, 1975] (b) Amount per ton. Tylosin, 40 or 100 EDITORIAL NOTE: For FEDERAL REGISTER ci- grams. tations affecting § 558.625, see the List of CFR (1) Indications for use. For control of Sections Affected, which appears in the swine dysentery associated with Finding Aids section of the printed volume Brachyspira hyodysenteriae, and for con- and at www.fdsys.gov. trol of porcine proliferative enteropathies (ileitis) associated with § 558.630 Tylosin and sulfamethazine. Lawsonia intracellularis. (a) Specifications. Type A medicated (2) Limitations. Use 100 grams per ton articles containing equal amounts of for at least 3 weeks followed by 40 tylosin phosphate and sulfamethazine, grams per ton until market weight; as available in concentrations of 4, 5, 10, tylosin phosphate. 20, or 40 grams each, per pound. (c) Amount per ton. Tylosin, 40–100 (b) Approvals. See sponsor numbers in grams. § 510.600(c) of this chapter for use as in (1) Indications for use. For the treat- paragraph (e) of this section. ment and control of swine dysentery (1) No. 000986: 10 or 40 grams per associated with Brachyspira pound each for use as in paragraph hyodysenteriae and for the control of (e)(2)(i) of this section. porcine proliferative enteropathies (2) [Reserved]

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(3) No. 051311: 40 grams per pound (3) Limitations. Withdraw 15 days be- each for use as in paragraph (e)(2)(ii) of fore swine are slaughtered. this section. [73 FR 34185, June 17, 2008, as amended at 73 (4) [Reserved] FR 35341, June 23, 2008; 75 FR 55677, Sept. 14, (5) Nos. 000986, 012286, 034936, and 2010; 76 FR 17778, Mar. 31, 2011; 77 FR 4897, 054771: 5, 10, 20, or 40 grams per pound Feb. 1, 2012; 78 FR 14669, Mar. 7, 2013; 79 FR each for use as in paragraph (e)(2)(ii) of 13546, Mar. 11, 2014] this section. § 558.635 Virginiamycin. (6) No. 000986: 40 grams per pound (a) Approvals. Type A medicated arti- each for use as in paragraph (e)(2)(iii) cles. (1) 1.1 percent activity (5 grams of this section. per pound), 2.2 percent activity (10 (c) Special considerations. Labeling grams per pound), 4.4 percent activity shall bear the statement: ‘‘Do not use (20 grams per pound), 11 percent activ- in medicated feeds containing in excess ity (50 grams per pound), and 50 percent of 2% bentonite.’’ activity (227 grams per pound) used as (d) Related tolerances. See §§ 556.670 in paragraph (d) of this section; and 30 and 556.740 of this chapter. percent activity (136.2 grams per (e) Conditions of use. It is used in feed pound) for the manufacture of Type C for swine as follows: medicated feed for cattle used as in (1) Amount per ton. 100 grams tylosin paragraph (d)(3); to 066104 in § 510.600(c) and 100 grams sulfamethazine. of this chapter. (2) Indications for use–(i) Maintaining (2) 2.2 percent activity (10 grams per weight gains and feed efficiency in the pound) to 054771 and 017790 in § 510.600(c) presence of atrophic rhinitis; lowering of this chapter for use as in paragraphs the incidence and severity of Bordetella (d)(1)(iv) and (d)(1)(v) of this section. bronchiseptica rhinitis; prevention of (b) Related tolerances. See § 556.750 of this chapter. swine dysentery (vibrionic); control of (c) Special considerations. (1) Not for swine pneumonias caused by bacterial use in breeding swine over 120 pounds. pathogens (Pasteurella multocida and/or (2) Dilute Type A article with at Corynebacterium pyogenes); for reducing least 10 pounds of a feed ingredient the incidence of cervical lymphadenitis prior to final mixing in 1 ton of Type C (jowl abscesses) caused by Group E feed. Streptococci. Only the sulfamethazine (d) Conditions of use—(1) Swine. It is portion of this combination is active in used as follows: controlling jowl abscesses. (i) 100 grams per ton for 2 weeks, for (ii) Maintaining weight gains and treatment of swine dysentery in non- feed efficiency in the presence of breeding swine over 120 pounds. atrophic rhinitis; lowering the inci- (ii) 100 grams per ton for 2 weeks, 50 dence and severity of Bordetella grams per ton thereafter, for treatment bronchiseptica rhinitis; prevention of and control of swine dysentery in swine swine dysentery (vibrionic); control of up to 120 pounds. swine pneumonias caused by bacterial (iii) 25 grams per ton, as an aid in pathogens (Pasteurella multocida and/or control of dysentery in swine up to 120 Corynebacterium pyogenes). pounds. For use in animals or on prem- (iii) For maintaining weight gains ises with a history of swine dysentery and feed efficiency in the presence of but where symptoms have not yet occurred. atrophic rhinitis; lowering the inci- (iv) 10 grams per ton from weaning up dence and severity of Bordetella to 120 pounds for increased rate of bronchiseptica rhinitis; prevention of weight gain and improved feed effi- swine dysentery associated with ciency, followed by 5 grams per ton to Brachyspira hyodysenteriae; and control market weight for increased rate of of swine pneumonias caused by bac- weight gain and improved feed effi- terial pathogens (Pasteurella multocida ciency. For continuous use from and/or Arcanobacterium pyogenes). weaning to market weight. (v) 10 grams per ton from weaning up to 120 pounds for increased rate of

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weight gain and improved feed effi- (vii) Semduramicin as in § 558.555. ciency, followed by 5 to 10 grams per [40 FR 13959, Mar. 27, 1975] ton to market weight for increased rate of weight gain. For continuous use EDITORIAL NOTE: For FEDERAL REGISTER ci- from weaning to market weight. tations affecting § 558.635, see the List of CFR (2) Poultry. It is used as follows: Sections Affected, which appears in the Finding Aids section of the printed volume (i) 5 to 15 grams per ton for increased and at www.fdsys.gov. rate of weight gain, for use in broiler chickens, not for use in layers. § 558.665 Zilpaterol. (ii) 5 grams per ton for increased rate (a) Specifications. Type A medicated of weight gain and improved feed effi- articles containing 21.77 grams (g) ciency in broiler chickens, not for use zilpaterol hydrochloride per pound. in layers. (b) Approvals. See No. 000061 in (iii) 20 grams per ton for prevention § 510.600(c) of this chapter. of necrotic enteritis caused by Clos- (c) Tolerances. See § 556.765 of this tridium perfringens susceptible to chapter. virginiamycin in broiler chickens; not (d)Special considerations—(1) Labeling for use in layers. of Type B and Type C cattle feeds shall (iv) 10 to 20 grams per ton for in- bear the following: creased rate of weight gain and im- (i) Do not allow horses or other proved feed efficiency in growing tur- equines access to feed containing keys. zilpaterol. (3) Cattle. It is used as follows: (ii) Not for use in animals intended (i) 16.0 to 22.5 grams per ton to pro- for breeding. vide 100 to 340 milligrams per head per (iii) Do not use in veal calves. day for increased rate of weight gain. (2) Type B Liquid Feeds can be manu- (ii) 13.5 to 16.0 grams per ton to pro- factured containing 68 to 680 g vide 85 to 240 milligrams per head per zilpaterol hydrochloride/ton. The liquid day for reduction of incidence of liver Type B feeds must be maintained at a abscesses. pH of 3.8 to 7.5. For liquid feeds stored (iii) 11.0 to 16.0 grams per ton to pro- in recirculating tank systems: Recircu- vide 70 to 240 milligrams per head per late immediately prior to use for not day for improved feed efficiency. less than 10 minutes, moving not less (iv) Feed continuously as sole ration than 1 percent of the tank contents per to cattle fed in confinement for slaugh- minute from the bottom of the tank to ter. Not for use in animals intended for the top. Recirculate daily as described breeding. even when not used. For liquid feeds (4) Virginiamycin may be used in stored in mechanical, air or other agi- combination with: tation-type tank systems: Agitate im- (i) Amprolium and ethopabate as in mediately prior to use for not less than § 558.58. 10 minutes, creating a turbulence at (ii) Diclazuril as in § 558.198. the bottom of the tank that is visible (iii) Halofuginone as in § 558.265. at the top. Agitate daily as described (iv) Lasalocid as in § 558.311. even when not used. (v) Monensin as in § 558.355. (e) Conditions of use in cattle. It is ad- (vi) Salinomycin as in § 558.550. ministered in feed as follows:

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

(1) 6.8 to provide 60 to 90 Cattle fed in confinement Feed continuously as the 000061 mg/head/day for slaughter: For in- sole ration during the creased rate of weight last 20 to 40 days on gain, improved feed effi- feed. Withdrawal period: ciency, and increased 3 days. carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed.

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

(2) 6.8 to provide 60 to 90 Melengestrol acetate to Heifers fed in confinement As in paragraph (e)(1) of 000061 mg/head/day provide 0.25 to 0.5 mg/ for slaughter: As in this section; see para- 000986 head/day paragraph (e)(1) of this graph §§ 558.342(d) of section; and for sup- this chapter. pression of estrus Melengestrol acetate as (heat). provided by Nos. 000986 or 054771 in § 510.600(c) of this chapter

(3) 6.8 to provide 60 to 90 Monensin 10 to 40 Cattle fed in confinement As in paragraph (e)(1) of 000061 mg/head/day for slaughter: As in this section; see para- paragraph (e)(1) of this graph § 558.355(d) of section; and for preven- this chapter. Monensin tion and control of coc- as provided by No. cidiosis due to Eimeria 000986 in § 510.600(c) bovis and E. zuernii. of this chapter.

(4) 6.8 to provide 60 to 90 Melengestrol acetate to Heifers fed in confinement As in paragraph (e)(1) of 000061 mg/head/day provide 0.25 to 0.5 mg/ for slaughter: As in this section; see 000986 head/day paragraph (e)(1) of this §§ 558.342(d) and section; for prevention 558.355(d) of this chap- and control of coccidi- ter. Monensin as pro- osis due to Eimeria vided by No. 000986; bovis and E. zuernii; and melengestrol ace- and for suppression of tate as provided by estrus (heat). Nos. 000986 or 054771 in § 510.600(c) of this chapter

(5) 6.8 to provide 60 to 90 Monensin 10 to 40, plus Cattle fed in confinement As in paragraph (e)(1) of 000061 mg/head/day tylosin 8 to 10 for slaughter: As in this section; see 016592 paragraph (e)(1) of this §§ 558.355(d) and section; for prevention 558.625(c) of this chap- and control of coccidi- ter. Monensin as pro- osis due to Eimeria vided by No. 000986; bovis and E. zuernii; tylosin as provided by and for reduction of in- Nos. 000986 or 016592 cidence of liver ab- in § 510.600(c) of this scesses caused by chapter Fusobacterium necrophorum and Arcanobacterum (Actinomyces) pyogenes

(6) 6.8 to provide 60 to 90 Monensin 10 to 40, plus Heifers fed in confinement As in paragraph (e)(1) of 000061 mg/head/day. tylosin 8 to 10, plus for slaughter: As in this section; see 000986 melengestrol acetate to paragraph (e)(1) of this §§ 558.342(d), 016592 provide 0.25 to 0.5 mg/ section; for prevention 558.355(d), and head/day. and control of coccidi- 558.625(c) of this chap- osis due to Eimeria ter. Monensin as pro- bovis and E. zuernii; for vided by No. 000986; reduction of incidence tylosin as provided by of liver abscesses Nos. 000986 or 016592; caused by and melengestrol ace- Fusobacterium tate as provided by necrophorum and Nos. 000986 or 054771 Arcanobacterium in § 510.600(c) of this (Actinomyces) chapter pyogenes; and for suppression of estrus (heat).

[71 FR 53006, Sept. 8, 2006, as amended at 72 FR 9245, Mar. 1, 2007; 72 FR 6019, Feb. 1, 2008; 73 FR 14385, Mar. 18, 2008; 73 FR 16755, Mar. 31, 2008; 73 FR 18959, Apr. 8, 2008; 73 FR 19432, Apr. 10, 2008; 74 FR 61517, Nov. 25, 2009; 75 FR 11451, Mar. 11, 2010; 77 FR 31724, May 30, 2012; 78 FR 42008, July 15, 2013]

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§ 558.680 Zoalene. (b) Approvals. See No. 054771 in § 510.600(c) of this chapter. (a) Specifications. Type A medicated (c) Related tolerances. See § 556.770 of article containing 25 percent zoalene. this chapter. (d) Conditions of use—(1) Chickens—

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%)

Zoalene in grams/ Combination in ton grams per ton Indications for use Limitations Sponsor

(ii) 36.3–113.5 ...... Bacitracin meth- Replacement chickens: For devel- Feed continuously as sole ration 054771 ylene disalicylate opment of active immunity to as in subtable in item (i). Grow- 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 methylene disalicylate as provided by No. 054771 in § 510.600(c) of this chapter. (iii) 36.3–113.5 ...... Bacitracin meth- Replacement chickens: For devel- Feed continuously as sole ration 054771 ylene disalicylate opment of active immunity to as in subtable in item (i). Grow- 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 methylene disalicylate 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 meth- Replacement chickens: For devel- Feed continuously as sole ration 054771 ylene disalicylate opment of active immunity to as in subtable in item (i). To 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 methylene disalicylate 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 meth- Broiler chickens: As an aid in the Feed continuously as sole ration. 054771 ylene disalicylate prevention and control of coc- Bacitracin methylene disalicy- 4 to 50. cidiosis; and for increased rate late as provided by No. 054771 of weight gain and improved in § 510.600(c) of this chapter. feed efficiency. (vii) 113.5 ...... Bacitracin meth- Broiler chickens: For prevention Feed continuously as sole ration. 054771 ylene disalicylate and control of coccidiosis; and Bacitracin methylene disalicy- 50. as an aid in the prevention of late as provided by No. 054771 necrotic enteritis caused or in § 510.600(c) of this chapter. complicated by Clostridium spp. or other organisms susceptible to bacitracin.

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Zoalene in grams/ Combination in ton grams per ton Indications for use Limitations Sponsor

(viii) 113.5 ...... Bacitracin meth- Broiler chickens: For prevention Feed continuously as sole ration. 054771 ylene disalicylate and control of coccidiosis; and To control necrotic enteritis, 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 methylene disalicylate 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. (x) 113.5 ...... Lincomycin 2 ...... Broiler chickens: As an aid in the Feed continuously as sole ration. 054771 prevention and control of coc- Do not feed to laying chickens. cidiosis; and for increased rate As lincomycin hydrochloride of weight gain and improved monohydrate provided by No. feed efficiency. 054771 in § 510.600(c) of this chapter.

(2) Turkeys—

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 meth- Growing turkeys: For prevention Feed continuously as sole ration 054771 ylene disalicylate and control of coccidiosis; and until 14 to 16 weeks of age. For 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.

[41 FR 11005, Mar. 15, 1976, as amended at 42 570.13 Indirect food additives resulting from FR 18618, Apr. 8, 1977; 42 FR 20817, Apr. 22, packaging materials prior sanctioned for 1977; 42 FR 36995, July 19, 1977; 51 FR 7401, animal feed and pet food. Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 55 FR 570.14 Indirect food additives resulting from 8461, Mar. 8, 1990; 57 FR 8403, Mar. 10, 1992; 57 packaging materials for animal feed and FR 8578, Mar. 11, 1992; 61 FR 35957, July 9, pet food. 1996; 63 FR 38750, July 20, 1998; 67 FR 6868, 570.15 Adoption of regulation on initiative Feb. 14, 2002; 71 FR 16223, Mar. 31, 2006; 71 FR of Commissioner. 27958, May 15, 2006; 76 FR 17027, Mar. 28, 2011; 570.17 Exemption for investigational use 79 FR 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, and procedure for obtaining authoriza- 2014] tion to market edible products from experimental animals. 570.18 Tolerances for related food additives. PART 564 [RESERVED] 570.19 Pesticide chemicals in processed foods. PART 570—FOOD ADDITIVES Subpart B—Food Additive Safety Subpart A—General Provisions 570.20 General principles for evaluating the safety of food additives. Sec. 570.30 Eligibility for classification as gen- 570.3 Definitions. erally recognized as safe (GRAS). 570.6 Opinion letters on food additive sta- 570.35 Affirmation of generally recognized tus. as safe (GRAS) status.

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570.38 Determination of food additive sta- (h) Scientific procedures include those tus. human, animal, analytical, and other AUTHORITY: 21 U.S.C. 321, 341, 342, 346a, 348, scientific studies, whether published or 371. unpublished, appropriate to establish SOURCE: 41 FR 38644, Sept. 10, 1976, unless the safety of a substance. otherwise noted. (i) Safe or safety means that there is a reasonable certainty in the minds of Subpart A—General Provisions competent scientists that the substance is not harmful under the in- § 570.3 Definitions. tended conditions of use. It is impos- (a) Secretary means the Secretary of sible in the present state of scientific Health and Human Services. knowledge to establish with complete (b) Department means the Department certainty the absolute harmlessness of of Health and Human Services. the use of any substance. Safety may (c) Commissioner means the Commis- be determined by scientific procedures sioner of Food and Drugs. or by general recognition of safety. In (d) As used in this part, the term act determining safety, the following fac- means the Federal Food, Drug, and tors shall be considered: Cosmetic Act approved June 25, 1936 (52 (1) The probable consumption of the Stat. 1040 et seq., as amended; 21 U.S.C. substance and of any substance formed 301–392). in or on food because of its use; (e) Food additives includes all sub- (2) The cumulative effect of the substances not exempted by section 201(s) stance in the diet, taking into account of the act, the intended use of which any chemically or pharmacologically results or may reasonably be expected related substance or substances in such to result, directly or indirectly, either diet; in their becoming a component of food (3) Safety factors which, in the opin- or otherwise affecting the characteris- ion of experts qualified by scientific tics of food. A material used in the pro- training and experience to evaluate the duction of containers and packages is safety of food and food ingredients, are subject to the definition if it may reasonably be expected to become a com- generally recognized as appropriate. ponent, or to affect the characteristics, (j) The term nonperishable processed directly or indirectly, of food packed in food means any processed food not sub- the container. Affecting the characteris- ject to rapid decay or deterioration tics of food does not include such phys- that would render it unfit for consump- ical effects, as protecting contents of tion. Not included are hermetically packages, preserving shape, and pre- sealed foods and other processed foods venting moisture loss. If there is no requiring refrigeration. migration of a packaging component (k) General recognition of safety shall from the package to the food, it does be determined in accordance with not become a component of the food § 570.30. and thus is not a food additive. A sub- (l) Prior sanction means an explicit stance that does not become a compo- approval granted with respect to use of nent of food, but that is used, for exam- a substance in food prior to September ple, in preparing an ingredient of the 6, 1958, by the Food Drug and Adminis- food to give a different flavor, texture, tration or the United States Depart- or other characteristic in the food, ment of Agriculture pursuant to the may be a food additive. Federal Food, Drug, and Cosmetic Act, (f) Common use in food means a sub- the Poultry Products Inspection Act, stantial history of consumption of a or the Meat Inspection Act. substance by a significant number of (m) Food includes human food, sub- animals in the United States. stances migrating to food from food- (g) The word substance in the defini- contact articles, pet food, and animal tion of the term food additive includes a feed. food or feed or a component of a food or feed consisting of one or more ingredi- [41 FR 38644, Sept. 10, 1976, as amended at 42 ents. FR 55206, Oct. 14, 1977]

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§ 570.6 Opinion letters on food addi- Drug Administration are hereby re- tive status. voked. (a) Over the years the Food and Drug (e) The prior opinions of the kind de- Administration has given informal scribed in paragraph (c) of this section written opinions to inquirers as to the will be replaced by qualified and cur- safety of articles intended for use as rent opinions if the recipient of each components of, or in contact with, such letter forwards a copy of each to food. Prior to the enactment of the the Department of Health and Human Food Additives Amendment of 1958 Services, Food and Drug Administra- (Pub. L. 85–929, Sept. 6, 1958), these tion, Center for Veterinary Medicine, opinions were given pursuant to sec- Office of Surveillance and Compliance tion 402(a)(1) of the Federal Food, (HFV–200), 7500 Standish Pl., Rockville, Drug, and Cosmetic Act, which reads in MD 20855, along with a copy of his let- part: ‘‘A food shall be deemed to be ter of inquiry, on or before July 23, adulterated if it bears or contains any 1970. poisonous or deleterious substance (f) This section does not apply to food which may render it injurious to additive status opinion letters per- health’’. taining to articles that were considered (b) Since enactment of the Food Ad- by the Food and Drug Administration ditives Amendment, the Food and Drug to be food additives nor to articles in- Administration has advised such included in regulations in this Sub- quirers 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 sanctioned for animal feed and pet (c) In the interest of the public food. health, such articles which have been 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 in- [42 FR 14091, Mar. 15, 1977] tended use, must be reexamined in the light of current scientific information § 570.14 Indirect food additives result- and current principles for evaluating ing from packaging materials for the safety of food additives if their use animal feed and pet food. is to be continued. Regulations providing for the use of (d) Because of the time span in- food packaging materials in parts 174 volved, copies of many of the letters in through 179 of this chapter are incor- which the Food and Drug Administra- porated in Subchapter E as applicable tion has expressed an informal opinion to packaging materials used for animal concerning the status of such articles feed and pet food. may no longer be in the file of the Food and Drug Administration. In the ab- [42 FR 14091, Mar. 15, 1977] sence of information concerning the 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 (a) The Commissioner upon his own reason all food additive status opinions initiative may propose the issuance of of the kind described in paragraph (c) a regulation prescribing, with respect of this section given by the Food and to any particular use of a food additive,

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the conditions under which such addi- with the regulations set forth in part 58 tive may be safely used. Notice of such of this chapter. proposal shall be published in the FED- [41 FR 38644, Sept. 10, 1976, as amended at 43 ERAL REGISTER and shall state the rea- FR 60023, Dec. 22, 1978] sons for the proposal. (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 § 570.17 Exemption for investigational having additive toxic effects and will use and procedure for obtaining au- be considered as related food additives. thorization to market edible prod- (b) Tolerances established for such ucts from experimental animals. related food additives may limit the A food additive or food containing a amount of a common component that food additive intended for investiga- may be present, or may limit the tional use by qualified experts shall be amount of biological activity (such as exempt from the requirements of sec- cholinesterase inhibition) that may be tion 409 of the act under the following present or may limit the total amount conditions: of related food additives that may be (a) If intended for investigational use present. in vitro or in laboratory research ani- (c) Where food additives from two or mals, it bears a label which states more chemicals in the same class are prominently, in addition to the other present in or on a food, the tolerance information required by the act, the for the total of such additives shall be warning: the same as that for the additive hav- Caution. Contains a new food additive for ing the lowest numerical tolerance in investigational use only in laboratory re- this class, unless there are available search animals or for tests in vitro. Not for methods that permit quantitative de- use in humans. termination of the amount of each food additive present or unless it is shown (b) If intended for use in animals that a higher tolerance is reasonably other than laboratory research animals and if the edible products of the ani- required for the combined additives to mals are to be marketed as food, per- accomplish the physical or technical mission for the marketing of the edible effect for which such combined addi- products as food has been requested by tives are intended and that the higher the sponsor, and authorization has tolerance will be safe. been granted by the Food and Drug Ad- (d) Where residues from two or more ministration in accordance with § 511.1 additives in the same class are present of this chapter or by the Department of in or on a food and there are available Agriculture in accordance with 9 CFR methods that permit quantitative de- 309.17, and it bears a label which states termination of each residue, the quan- prominently, in addition to the other tity of combined residues that are information required by the act, the within the tolerance may be deter- warning: mined as follows: (1) Determine the quantity of each Caution. Contains a new food additive for residue present. use only in investigational animals. Not for use in humans. (2) Divide the quantity of each res- Edible products of investigational animals idue by the tolerance that would apply are not to be used for food unless authoriza- if it occurred alone, and multiply by tion has been granted by the U.S. Food and 100 to determine the percentage of the Drug Administration or by the U.S. Depart- permitted amount of residue present. ment of Agriculture. (3) Add the percentages so obtained (c) If intended for nonclinical labora- for all residues present. tory studies in food-producing animals, (4) The sum of the percentages shall the study is conducted in compliance not exceed 100 percent.

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§ 570.19 Pesticide chemicals in proc- the National Academy of Sciences-Na- essed foods. tional Research Council. A petition When pesticide chemical residues will not be denied, however, by reason occur in processed foods due to the use of the petitioner’s having followed proof raw agricultural commodities that cedures other than those outlined in bore or contained a pesticide chemical the publications of the National Acad- 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 in the processed food when ready to eat set forth in the above-mentioned publi- is higher than the tolerance prescribed cations will apply to any substance for the raw agricultural commodity, that may properly be classified as a the processed food is adulterated unless food additive as defined in section the higher concentration is permitted 201(s) of the act. by a tolerance obtained under section (b) Upon written request describing 409 of the act. For example, if fruit the proposed use of an additive and the bearing a residue of 7 parts per million proposed experiments to determine its of DDT permitted on the raw agricul- safety, the Commissioner will advise a tural commodity is dried and a residue person who wishes to establish the in excess of 7 parts per million of DDT safety of a food additive whether he be- results on the dried fruit, the dehy- lieves the experiments planned will drated fruit is adulterated unless the yield data adequate for an evaluation higher tolerance for DDT is authorized of the safety of the additive. by the regulations in this part. Food that is itself ready to eat, and which § 570.30 Eligibility for classification as contains a higher residue than allowed generally recognized as safe for the raw agricultural commodity, (GRAS). may not be legalized by blending or (a) General recognition of safety may mixing with other foods to reduce the be based only on the views of experts residue in the mixed food below the tol- qualified by scientific training and ex- erance prescribed for the raw agricul- perience to evaluate the safety of sub- tural commodity. stances directly or indirectly added to food. The basis of such views may be ei- Subpart B—Food Additive Safety ther (1) scientific procedures or (2) in § 570.20 General principles for evalu- the case of a substance used in food ating the safety of food additives. prior to January 1, 1958, through expe- (a) In reaching a decision on any perience based on common use in food. tition filed under section 409 of the act, General recognition of safety requires the Commissioner will give full consid- common knowledge about the sub- eration to the specific biological prop- stance throughout the scientific com- erties of the compound and the ade- munity knowledgeable about the safety quacy of the methods employed to of substances directly or indirectly demonstrate safety for the proposed added to food. use, and the Commissioner will be (b) General recognition of safety guided by the principles and procedures based upon scientific procedures shall for establishing the safety of food addi- require the same quantity and quality tives stated in current publications of of scientific evidence as is required to

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obtain approval of a food additive regu- specifications, shall be of a purity suit- lation for the ingredient. General rec- able for its intended use. ognition of safety through scientific (2) It performs an appropriate func- procedures shall ordinarily be based tion in the food or food-contact article upon published studies which may be in which it is used. corroborated by unpublished studies (3) It is used at a level no higher than and other data and information. necessary to achieve its intended pur- (c) General recognition of safety pose in that food or, if used as a compo- through experience based on common nent of a food-contact article, at a use in food prior to January 1, 1958, level no higher than necessary to may be determined without the quan- achieve its intended purpose in that ar- tity or quality of scientific procedures ticle. required for approval of a food additive (g) New information may at any time regulation. General recognition of safe- require reconsideration of the GRAS ty through experience based on com- status of a food ingredient. Any change mon use in food prior to January 1, in status shall be accomplished pursu- 1958, shall ordinarily be based upon ant to § 570.38. generally available data and informa- (h) If a substance is affirmed as tion. An ingredient not in common use GRAS pursuant to § 570.35 and listed in in food prior to January 1, 1958, may a regulation with no limitation other achieve general recognition of safety than good manufacturing practice, it only through scientific procedures. shall be regarded as GRAS if its condi- (d) The food ingredients listed as tions of use are not significantly dif- GRAS in part 582 of this chapter do not ferent from those reported in the regu- include all substances that are gen- lation as the basis on which the GRAS erally recognized as safe for their in- status of the substance was affirmed. If tended use in food. Because of the large the conditions of use are significantly number of substances the intended use different, such use of the substance of which results or may reasonably be may not be GRAS. In such case a man- expected to result, directly or indi- ufacturer may not rely on the regula- rectly, in their becoming a component tion as authorizing the use but must or otherwise affecting the characteris- independently establish that the use is tics of food, it is impracticable to list GRAS or must use the substance in ac- all such substances that are GRAS. A cordance with a food additive regula- food ingredient of natural biological tion. origin that has been widely consumed (i) If an ingredient is affirmed as for its nutrient properties in the GRAS pursuant to § 570.35 and listed in United States prior to January 1, 1958, a regulation with specific limitation(s), without known detrimental effects, it may be used in food only within such which is subject only to conventional limitation(s) (including the category of processing as practiced prior to Janu- food(s), the functional use(s) of the in- ary 1, 1958, and for which no known gredient, and the level(s) of use). Any safety hazard exists, will ordinarily be use of such and ingredient not in full regarded as GRAS without specific in- compliance with each such established clusion in part 582 of this chapter. limitation shall require a food additive (e) A food ingredient that is not regulation. GRAS or subject to a prior sanction re- (j) Pursuant to § 570.35, a food ingre- quires a food additive regulation pro- dient may be affirmed as GRAS and mulgated under section 409 of the act listed in a regulation for a specific before it may be directly or indirectly use(s) without a general evaluation of added to food. use of the ingredient. In addition to the (f) A food ingredient that is listed as use(s) specified in the regulation, other GRAS in part 582 of this chapter shall uses of such an ingredient may also be be regarded as GRAS only if, in addi- GRAS. Any affirmation of GRAS status tion to all the requirements in the ap- for a specific use(s), without a general plicable regulation, it also meets all of evaluation of use of the ingredient, is the following requirements: subject to reconsideration upon such (1) It complies with any applicable evaluation. specifications, or in the absence of such [42 FR 55206, Oct. 14, 1977]

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§ 570.35 Affirmation of generally recog- (c) Chemical Abstract Service (CAS) nized as safe (GRAS) status. registry number. (a) The Commissioner, either on his (d) Empirical formula. initiative or on the petition of an in- (e) Structural formula. terested person, may affirm the GRAS (f) Specifications for food grade ma- status of substances that directly or terial, including arsenic and heavy indirectly become components of food. metals. (Recommendation for any change in the Food Chemicals Codex (b)(1) If the Commissioner proposes monograph should be included where on his own initiative that a substance applicable.) is entitled to affirmation as GRAS, he (g) Quantitative compositions. will place all of the data and informa- (h) Manufacturing process (excluding tion on which he relies on public file in any trade secrets). the office of the Division of Dockets (ii) Use of the substance, including: Management and will publish in the (a) Date when use began. FEDERAL REGISTER a notice giving the (b) Information and reports or other name of the substance, its proposed data on past uses in food. uses, and any limitations proposed for (c) Foods in which used, and levels of purposes other than safety. use in such foods, and for what pur- (2) The FEDERAL REGISTER notice will poses. allow a period of 60 days during which (iii) Methods for detecting the sub- any interested person may review the stance in food, including: data and information and/or file com- (a) References to qualitative and ments with the Division of Dockets quantitative methods for determining Management. Copies of all comments the substance(s) in food, including the received shall be made available for ex- type of analytical procedures used. amination in the Division of Dockets (b) Sensitivity and reproducibility of Management’s office. such method(s). (3) The Commissioner will evaluate (iv) Information to establish the safe- all comments received. If he concludes ty and functionality of the substance that there is convincing evidence that in food. Published scientific literature, the substance is GRAS as defined in evidence that the substance is identical § 570.3(k), he will publish a notice in the to a GRAS counterpart of natural bio- FEDERAL REGISTER listing the sub- logical origin, and other data may be stance in this subchapter E as GRAS. submitted to support safety. Any ad- (4) If, after evaluation of the com- verse information or consumer comments, the Commissioner concludes plaints shall be included. Complete bib- that there is a lack of convincing evi- liographic references shall be provided dence that the substance is GRAS and where a copy of the article is not pro- that it should be considered a food ad- vided. ditive subject to section 409 of the act, (v) A statement signed by the person he shall publish a notice thereof in the responsible for the petition that to the FEDERAL REGISTER in accordance with best of his knowledge it is a represent- § 570.38. ative and balanced submission that in- (c)(1) Persons seeking the affirmation cludes unfavorable information, as well of GRAS status of substances as pro- as favorable information, known to vided for in § 570.30(e), except those sub- him pertinent to the evaluation of the ject to the NAS-NRC GRAS list survey safety and functionality of the sub- (36 FR 20546), shall submit a petition stance. for GRAS affirmation pursuant to part (vi) If nonclinical laboratory studies 10 of this chapter. Such petition shall are involved, additional information contain information to establish that and data submitted in support of filed the GRAS criteria as set forth in petitions shall include, with respect to § 570.30(b) have been met, in the fol- each nonclinical study, either a state- lowing form: ment that the study was conducted in (i) Description of the substance, in- compliance with the requirements set cluding: forth in part 58 of this chapter, or, if (a) Common or usual name. the study was not conducted in compli- (b) Chemical name. ance with such regulations, a brief

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statement of the reason for the non- at any later time. The notice of filing compliance. will also constitute a proposal to estab- (vii) [Reserved] lish a regulation under this subchapter (viii) A claim for categorical exclu- E, incorporating the same provisions, sion under § 25.30 or 25.32 of this chapter in the event that such a regulation is or an environmental assessment under determined to be appropriate as a re- § 25.40 of this chapter. sult of submission of proof of such an (2) Within 30 days after the date of applicable prior sanction in response to filing the petition, the Commissioner the notice of filing. will place the petition on public file in the Division of Dockets Management [41 FR 38644, Sept. 10, 1976, as amended at 42 and will publish a notice of filing in the FR 4717, Jan. 25, 1977; 42 FR 15675, Mar. 22, FEDERAL REGISTER giving the name of 1977; 42 FR 55207, Oct. 10, 1977; 50 FR 7517, the petitioner and a brief description of Feb. 22, 1985; 50 FR 16668, Apr. 26, 1985; 54 FR 18281, Apr. 28, 1989; 62 FR 40600, July 29, 1997] the petition including the name of the substance, its proposed use, and any § 570.38 Determination of food addi- limitations proposed for reasons other tive status. than safety. A copy of the notice will be mailed to the petitioner at the time (a) The Commissioner may, in ac- the original is sent to the FEDERAL cordance with § 570.35 (b)(4) or (c)(5), REGISTER. publish a notice in the FEDERAL REG- (3) The notice of filing in the FED- ISTER determining that a substance is ERAL REGISTER will allow a period of 60 not GRAS and is a food additive sub- days during which any interested per- ject to section 409 of the act. son may review the petition and/or file (b)(1) The Commissioner, on his own comments with the Division of Dockets initiative or on the petition of any in- Management. Copies of all comments terested person, pursuant to part 10 of received shall be made available for ex- this chapter, may issue a notice in the amination in the Division of Dockets FEDERAL REGISTER proposing to deter- Management. mine that a substance is not GRAS and (4) The Commissioner will evaluate is a food additive subject to section 409 the petition and all available informa- of the act. Any petition shall include tion including all comments received. all relevant data and information of If the petition and such information the type described in § 571.130(b) of this provide convincing evidence that the chapter. The Commissioner will place substance is GRAS as defined in § 570.3, all of the data and information on he will publish an order in the FEDERAL which he relies on public file in the Di- REGISTER listing the substance in this vision of Dockets Management and will subchapter E as GRAS. include in the FEDERAL REGISTER no- (5) If, after evaluation of the petition tice the name of the substance, its and all available information, the Com- known uses, and a summary of the missioner concludes that there is a basis for the determination. lack of convincing evidence that the substance is GRAS and that it should (2) The FEDERAL REGISTER notice will be considered a food additive subject to allow a period of 60 days during which section 409 of the act, he shall publish any interested person may review the a notice thereof in the FEDERAL REG- data and information and/or file com- ISTER in accordance with § 570.38. ments with the Division of Dockets (6) The notice of filing in the FED- Management. Copies of all comments ERAL REGISTER will request submission shall be made available for examina- of proof of any applicable prior sanction in the Division of Dockets Man- tion for use of the ingredient under agement. conditions different from those pro- (3) The Commissioner will evaluate posed to be determined to be GRAS. all comments received. If he concludes The failure of any person to come for- that there is a lack of convincing evi- ward with proof of such an applicable dence that the substance is GRAS or is prior sanction in response to the notice otherwise exempt from the definition of filing will constitute a waiver of the of a food additive in section 201(s) of right to assert or rely on such sanction the act, he will publish a notice thereof

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in the FEDERAL REGISTER. If he con- PART 571—FOOD ADDITIVE cludes that there is convincing evi- PETITIONS dence that the substance is GRAS, he will publish an order in the FEDERAL Subpart A—General Provisions REGISTER listing the substance in this subchapter E as GRAS. Sec. 571.1 Petitions. (c) A FEDERAL REGISTER notice deter- 571.6 Amendment of petition. mining that a substance is a food addi- 571.7 Withdrawal of petition without preju- tive shall provide for the use of the ad- dice. ditive in food or food-contact surfaces as follows: Subpart B—Administrative Actions on (1) It may promulgate a food additive Applications regulation governing use of the addi- 571.100 Regulation based on petition. tive. 571.102 Effective date of regulation. (2) It may promulgate an interim 571.110 Procedure for objections and hear- food additive regulation governing use ings. of the additive. 571.115 Application of the cancer clause of (3) It may require discontinuation of section 409 of the act. the use of the additive. 571.130 Procedure for amending and repealing tolerances or exemptions from toler- (4) It may adopt any combination of ances. the above three approaches for dif- AUTHORITY: 21 U.S.C. 321, 342, 348, 371; 42 ferent uses or levels of use of the addi- U.S.C. 241. tive. (d) If the Commissioner of Food and SOURCE: 41 FR 38647, Sept. 10, 1976, unless otherwise noted. Drugs is aware of any prior sanction for use of the substance, he will concurrently propose a separate regulation Subpart A—General Provisions covering such use of the ingredient § 571.1 Petitions. under this subchapter E. If the Com- missioner is unaware of any such appli- (a) Petitions to be filed with the cable prior sanction, the proposed regu- Commissioner under the provisions of lation will so state and will require any section 409(b) of the act shall be sub- person who intends to assert or rely on mitted in triplicate. If any part of the such sanction to submit proof of its ex- material submitted is in a foreign lan- istence. Any regulation promulgated guage, it shall be accompanied by an pursuant to this section constitutes a accurate and complete English trans- determination that excluded uses lation. The petition shall state peti- would result in adulteration of the food tioner’s post office address to which in violation of section 402 of the act, published notices or orders issued or objections filed pursuant to section 409 and the failure of any person to come of the act may be sent. forward with proof of such an applica- (b) Pertinent information may be in- ble prior sanction in response to the corporated in, and will be considered as proposal will constitute a waiver of the part of, a petition on the basis of spe- right to assert or rely on such sanction cific reference to such information sub- at any later time. The notice will also mitted to and retained in the files of constitute a proposal to establish a the Food and Drug Administration. regulation under this subchapter E., in- However, any reference to unpublished corporating the same provisions, in the information furnished by a person event that such a regulation is deter- other than the applicant will not be mined to be appropriate as a result of considered unless use of such informa- submission of proof of such an application is authorized in a written state- ble prior sanction in response to the ment signed by the person who sub- proposal. mitted it. Any reference to published [41 FR 38644, Sept. 10, 1976, as amended at 42 information offered in support of a FR 4717, Jan. 25, 1977; 42 FR 15675, Mar. 22, food-additive petition should be accom- 1977; 42 FR 55207, Oct. 14, 1977; 54 FR 18281, panied by reprints or photostatic cop- Apr. 28, 1989] 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 573.310 Crambe meal, heat toasted. have the potential to contaminate 573.320 Diammonium phosphate. human food with residues whose con- 573.340 Diatomaceous earth. sumption could present a risk of cancer 573.360 Disodium EDTA. 573.380 Ethoxyquin in animal feeds. to people must satisfy the require- 573.400 Ethoxyquin in certain dehydrated ments of subpart E of part 500 of this forage crops. chapter. 573.420 Ethyl cellulose. 573.440 Ethylene dichloride. [52 FR 49588, Dec. 31, 1987] 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. 573.500 Condensed, extracted glutamic acid (a) The Commissioner, on his own fermentation product. initiative or on the petition of any in- 573.520 Hemicellulose extract. terested person, pursuant to part 10 of 573.530 Hydrogenated corn syrup. this chapter, may propose the issuance 573.540 Hydrolyzed leather meal. of a regulation amending or repealing a 573.560 Iron ammonium citrate. regulation pertaining to a food additive 573.580 Iron-choline citrate complex. 573.600 Lignin sulfonates. or granting or repealing an exception 573.620 Menadione dimethylpyrimidinol bi- for such additive. sulfite. (b) Any such petition shall include an 573.625 Menadione nicotinamide bisulfite. assertion of facts, supported by data, 573.637 Methyl esters of conjugated linoleic showing that new information exists acid (cis-9, trans-11 and trans-10, cis-12- with respect to the food additive or octadecadienoic acids). that new uses have been developed or 573.640 Methyl esters of higher fatty acids. old uses abandoned, that new data are 573.660 Methyl glucoside-coconut oil ester. 573.680 Mineral oil. available as to toxicity of the chem- 573.685 Natamycin. ical, or that experience with the exist- 573.700 Sodium nitrite. ing regulation or exemption may jus- 573.720 Petrolatum. tify its amendment or repeal. New data 573.740 Odorless light petroleum hydro- shall be furnished in the form specified carbons. in § 571.1 for submitting petitions. 573.750 Pichia pastoris dried yeast. 573.760 Poloxalene. [42 FR 4717, Jan. 25, 1977; 42 FR 15676, Mar. 22, 573.780 Polyethylene. 1977] 573.800 Polyethylene glycol (400) mono- and dioleate. PART 573—FOOD ADDITIVES PER- 573.820 Polyoxyethylene glycol (400) mono- and dioleates. MITTED IN FEED AND DRINKING 573.840 Polysorbate 60. WATER OF ANIMALS 573.860 Polysorbate 80. 573.870 Poly(2-vinylpyridine-co-styrene). Subpart A [Reserved] 573.880 Normal propyl alcohol. 573.900 Pyrophyllite. Subpart B—Food Additive Listing 573.914 Salts of volatile fatty acids. 573.920 Selenium. Sec. 573.940 Silicon dioxide. 573.120 Acrylamide-acrylic acid resin. 573.960 Sorbitan monostearate. 573.130 Aminoglycoside 3′-phospho- trans- 573.980 Taurine. ferase II. 573.1000 Verxite. 573.140 Ammoniated cottonseed meal. 573.1010 Xanthan gum. 573.160 Ammoniated rice hulls. 573.1020 Yellow prussiate of soda. 573.170 Ammonium formate. 573.180 Anhydrous ammonia. AUTHORITY: 21 U.S.C. 321, 342, 348. 573.200 Condensed animal protein hydroly- SOURCE: 41 FR 38652, Sept. 10, 1976, unless sate. otherwise noted. 573.210 Benzoic acid. 573.220 Feed-grade biuret. 573.225 1,3-Butylene glycol. Subpart A [Reserved] 492

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Subpart B—Food Additive Listing kanr gene along with the genetic material of interest. § 573.120 Acrylamide-acrylic acid [59 FR 26711, May 23, 1994] resin. Acrylamide-acrylic acid resin § 573.140 Ammoniated cottonseed (hydrolized polyacrylamide), only for meal. the purposes of this section as de- The food additive ammoniated cot- scribed below, may be safely used in ac- tonseed meal may be safely used in accordance with the following prescribed cordance with the following conditions: conditions: (a) The food additive is the product (a) The additive is produced by po- obtained by the treatment of cotton- lymerization of acrylamide with par- seed meal with anhydrous ammonia tial hydrolysis, or by copolymerization until a pressure of 50 pounds per square of acrylamide and acrylic acid with the inch gauge is reached. greater part of the polymer being com- (b) It is used or intended for use in posed of acrylamide units. the feed of ruminants as a source of 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. (4) A statement: [41 FR 38652, Sept. 10, 1976, as amended at 45 (i) That not more than one-third of FR 38058, June 6, 1980] the total protein in the feed should come from nonprotein nitrogen § 573.130 Aminoglycoside 3′-phosphotransferase II. sources. (ii) That the additive is not to be The food additive aminoglycoside 3′- given to debilitated or starved animals. phosphotransferase II may be safely (iii) ‘‘Warning—This feed should be used in the development of genetically used only in accordance with directions modified cotton, oilseed rape, and to- furnished on the label.’’ matoes in accordance with the following prescribed conditions: [41 FR 38652, Sept. 10, 1976, as amended at 42 FR 52397, Sept. 30, 1977] (a) The food additive is the enzyme aminoglycoside 3′-phosphotransferase § 573.160 Ammoniated rice hulls. II (CAS Reg. No. 58943–39–8) which cata- The food additive ammoniated rice lyzes the phosphorylation of certain hulls may be safely used in accordance aminoglycoside antibiotics, including with the following prescribed condi- kanamycin, neomycin, and gentamicin. tions: (b) Aminoglycoside 3′- (a) The food additive is the product phosphotransferase II is encoded by the obtained by the treatment of ground kanr gene originally isolated from rice hulls with monocalcium phosphate transposon Tn5 of the bacterium Esch- and anhydrous ammonia at a tempera- erichia coli. ture of 350 °F and a pressure of 175 (c) The level of the additive does not pounds per square inch. exceed the amount reasonably required (b) It is used or intended for use in for selection of plant cells carrying the the feed of beef cattle as a source of

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crude fiber and as the sole source of mate (37 percent ammonium salt of for- nonprotein nitrogen in an amount not mic acid and 62 percent formic acid). to exceed 20 percent of the total ration. (2) Statements identifying ammo- (c) To assure safe use of the additive, nium formate in formic acid (37 per- the label and labeling of the additive cent ammonium salt of formic acid and and of any feed additive supplement, 62 percent formic acid) as a corrosive feed additive concentrate, or feed addi- and possible severe irritant. tive premix prepared therefrom, shall (3) Information about emergency aid contain, in addition to other informa- in case of accidental exposure as fol- tion required by the act, the following: lows: (1) The name of the additive. (2) The maximum percentage of (i) Statements reflecting require- equivalent crude protein from the non- ments of applicable sections of the protein nitrogen. Superfund Amendments and Reauthor- (3) Directions for use to provide not ization Act (SARA), and the Occupa- more than 20 percent of the additive in tional Safety and Health Administra- the total ration, and a prominent tion’s (OSHA) human safety guidance statement: ‘‘Warning—This feed should regulations. be used only in accordance with the di- (ii) Contact address and telephone rections furnished on the label.’’ number for reporting adverse reactions or to request a copy of the Material § 573.170 Ammonium formate. Safety Data Sheet (MSDS). The food additive, ammonium formate, may be safely used in the manu- [75 FR 41725, July 19, 2010, as amended at 78 FR 42692, July 17, 2013] facture of complete swine feeds in accordance with the following prescribed § 573.180 Anhydrous ammonia. conditions: (a) The additive is manufactured by (a) The food additive anhydrous am- the reaction of 99.5 percent ammonia monia is applied directly to corn plant gas and 99 percent formic acid in a con- material and thoroughly blended prior tinuous loop reactor to produce a solu- to ensiling. It is used or intended for tion made up of 37 percent ammonium use as a source of nonprotein nitrogen salt of formic acid and 62 percent for- in cattle feed in accordance with para- mic acid. graphs (a)(1), (2), or (3) as follows: (b) The additive is used or intended (1)(i) The food additive anhydrous for use as a feed acidifying agent, to ammonia is applied as a component of lower the pH, in complete swine feeds an aqueous premix containing 16 to 17 at levels not to exceed 1.2 percent of percent ammonia, with molasses, min- the complete feed. erals, and not less than 83 percent (c) To assure safe use of the additive, crude protein. The premix is a source in addition to the other information re- of nonprotein nitrogen and minerals. quired by the Federal Food, Drug, and (ii) In addition to the requirements of Cosmetic Act (the act), the label and paragraph (b) of this section, the label- labeling shall contain: ing shall bear an expiration date of not (1) The name of the additive. more than 10 weeks after date of manu- (2) Adequate directions for use in- facture; a statement that additional cluding a statement that ammonium formate must be uniformly applied and protein should not be fed to lactating thoroughly mixed into complete swine dairy cows producing less than 32 feeds and that the complete swine feeds pounds of milk per day nor beef cattle so treated shall be labeled as con- consuming less than 1 percent of body taining ammonium formate. weight daily in shelled corn; and a (d) To assure safe use of the additive, warning not to use additional trace in addition to the other information re- mineral supplementation with treated quired by the act and paragraph (c) of silage. this section, the label and labeling (2)(i) The food additive anhydrous shall contain: ammonia is applied directly to corn (1) Appropriate warnings and safety plant material for use in dairy or beef precautions concerning ammonium for- cattle rations.

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(ii) The anhydrous ammonia is ap- (2) In feed concentrates for cattle in plied at a rate not to exceed the equiv- an amount not to exceed 10 percent by alent of 0.35 percent of the corn plant weight of the concentrate. material. (d) Labeling. The label and labeling (iii) It is applied to corn plant mate- shall bear, in addition to the other in- rial containing 30 to 35 percent dry formation required by the act: matter. (1) The name of the additive, con- (iv) It is applied so that 75 to 85 per- densed animal protein hydrolysate. cent of the additive is liquid at ambi- (2) Adequate directions for use in- ent pressure. cluding maximum quantities permitted (3)(i) The food additive anhydrous for each species and a guaranteed anal- ammonia is applied after being diluted ysis of the additive. to a 15 to 30 percent aqueous ammonia solution (by weight). § 573.210 Benzoic acid. (ii) The anhydrous ammonia solution is applied at a rate not to exceed anhy- The food additive, benzoic acid, may drous ammonia equivalent to 0.3 per- be safely used in the manufacture of cent of the corn plant material. complete swine feeds in accordance (iii) It is applied to corn plant mate- with the following prescribed condi- rial containing 28 to 38 percent dry tions: matter. (a) The additive is used or intended (iv) The silage treated with aqueous for use as a feed acidifying agent, to ammonia is to be fed to dairy cattle lower the pH, in complete swine feeds only. at levels not to exceed 0.5 percent of (b) Its labeling shall bear, in addition the complete feed. to the other requirements of the act, (b) The additive consists of not less the name of the additive, the con- than 99.5 percent benzoic acid (CAS 65– centration of ammonia, the maximum 85–0) by weight with the sum of 2- percentage of equivalent crude protein methylbiphenyl, 3-methylbiphenyl, 4- from nonprotein nitrogen, and direc- methylbiphenyl, benzyl benzoate, and tions for use consistent with this sec- isomers of dimethylbiphenyl not to ex- tion. ceed 0.01 percent by weight. (c) To assure safe use of the additive, [44 FR 40284, July 10, 1979] in addition to the other information re- § 573.200 Condensed animal protein quired by the Federal Food, Drug, and hydrolysate. Cosmetic Act and paragraph (b) of this section, the label and labeling shall (a) Identity. The condensed animal protein hydrolysate is produced from contain: the meat byproducts scraped from (1) The name of the additive. cured (salted) hides taken from cattle (2) Adequate directions for use in- slaughtered for food consumption. The cluding a statement that benzoic acid meat byproduct is hydrolyzed with must be uniformly applied and thor- heat and phosphoric acid. oughly mixed into complete swine (b) Specifications. The additive shall feeds and that the complete swine feeds conform to the following percent-by- so treated shall be labeled as con- weight specifications: taining benzoic acid. (3) Appropriate warnings and safety Moisture, not less than 45 percent nor more precautions concerning benzoic acid. than 50 percent. Protein, not less than 24 percent. (4) A warning statement identifying Salt (NaCl), not more than 15 percent. benzoic acid as a possible irritant. Phosphorus, not less than 2.25 percent. (5) Information about emergency aid in case of accidental exposure. (c) Uses. It is used or intended for use (6) Contact address and telephone as a source of animal protein, phos- number for reporting adverse reactions phorus, and salt (NaCl) as follows: or to request a copy of the Material (1) In poultry and swine feed in an Safety Data Sheet (MSDS). amount not to exceed 5 percent by weight of the feed. [79 FR 14176, Mar. 13, 2014]

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§ 573.220 Feed-grade biuret. § 573.240 Calcium periodate. The food additive feed grade biuret The food additive calcium periodate may be safely used in ruminant feed in may be safely used in accordance with accordance with the following pre- the following prescribed conditions: scribed conditions: (a) The additive is produced by react- (a) The food additive is the product ing calcium iodate with calcium hy- resulting from the controlled pyrolysis droxide or calcium oxide to form a sub- of urea conforming to the following stance consisting of not less than 60 specifications: percent by weight of penta calcium Percent orthoperiodate containing 28 to 31 percent by weight of iodine. Biuret ...... 55 minimum. Urea ...... 15 maximum. (b) It is used or intended for use in Cyanuric acid and triuret ...... 30 maximum. salt for livestock as a source of iodine. Mineral oil ...... 0.5 maximum. Total nitrogen (equivalent to 218.75 pct 35 minimum. crude protein). § 573.260 Calcium silicate. Calcium silicate, including synthetic (b) It is used in ruminant feeds as a calcium silicate, may be safely used as source of nonprotein nitrogen. an anticaking agent in animal feed, (c) To assure safe use of the additive: provided that the amount of calcium (1) The label and labeling of the addi- silicate does not exceed 2 percent. tive and that of any feed additive supplement, 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 [41 FR 38652, Sept. 10, 1976, as amended at 68 contained in the mixture, but such as- FR 27904, May 22, 2003] sociated fatty acids in aggregate do not exceed 35 percent by weight of the mix- § 573.225 1,3-Butylene glycol. ture. The fatty acids may be derived The food additive 1,3-butylene glycol from feed-grade fats or oils. (1,3-butanediol) may be safely used in (b) The additives meet the following accordance with the following pre- specifications: scribed conditions: (1) Unsaponifiable matter does not (a) It complies with the specifica- exceed 2 percent. tions in § 173.220(a) of this chapter. (2) They are free of chick-edema fac- (b) It is intended for use in swine feed tor. as a source of energy. (c) The additives are manufactured so (c) It is to be thoroughly mixed into feed at levels not to exceed 9 percent of that in aqueous solution they are ex- the dry matter of the total ration. posed for 1 hour or longer to tempera- ° (d) 1,3-Butylene glycol should be ture in excess of 180 F. mixed in feed with equipment adapted (d) They are used as anticaking for the addition of liquids, and the feed agents in animal feeds in accordance should be mixed not less than 5 min- with current good manufacturing prac- utes after its addition. tices. [53 FR 40061, Oct. 13, 1988] [63 FR 8573, Feb. 20, 1998]

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§ 573.300 Choline xanthate. 2 percent of equivalent crude protein in Choline xanthate may be safely used the total daily ration. as a component of animal feed as an (c) To assure safe use of the additive, added source of choline to supplement the label and labeling of the additive the diets of poultry, ruminants, and and that of any feed additive supple- swine in accordance with good feeding ment, feed additive concentrate, feed practice. additive premix, or complete feed prepared therefrom shall contain, in addi- § 573.310 Crambe meal, heat toasted. tion to other information required by (a) The additive is the seed meal of the act, the following: Crambe abyssinica obtained after the re- (1) The name of the additive. moval of oil from the seed and hull. (2) The maximum percentage of The oil may be removed by pre-press equivalent crude protein from the non- solvent extraction or by solvent ex- protein nitrogen. traction alone. The resulting seed meal (3) If the feed additive premix, feed is heat toasted. additive concentrate, or feed additive (b) The additive conforms to the fol- supplement contains more than 2 per- lowing percent-by-weight specifica- cent equivalent crude protein from tions: moisture, not more than 11 per- diammonium phosphate, adequate di- cent; oil, not more than 4 percent; rections for use and a prominent state- crude protein, not less than 24 percent; ment, ‘‘Warning—This feed should be crude fiber, not more than 26 percent; used only in accordance with directions glucosinolate calculated as epi- furnished on the label.’’ progoitrin, not more than 4 percent; goitrin, not more than 0.1 percent; § 573.340 Diatomaceous earth. nitrile calculated as 1-cyano-2-hy- (a) Identity. The additive consists of droxy-3-butene, not more than 1.4 per- siliceous skeletal material derived cent. At least 50 percent of the nitro- from various species of diatoms. gen shall be soluble in 0.5 M sodium (b) Specifications. The additive shall chloride. Myrosinase enzyme activity conform to the following specifica- shall be absent. tions: (c) The additive is used or intended for use in the feed of feedlot cattle as Lead, not more than 15 parts per million. Arsenic (as As), not more than 20 parts per a source of protein in an amount not to million exceed 4.2 percent of the total ration. Fluorine, not more than 600 parts per mil- [46 FR 30082, June 5, 1981] lion. (c) Uses. It is used or intended for use § 573.320 Diammonium phosphate. 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. (b) It is used in ruminant feeds as a (c) It is used or intended for use in an source of phosphorus and nitrogen in amount not to exceed 240 parts per mil- an amount that supplies not more than lion of the additive in finished feed.

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(d) To assure safe use of the additive (a) It may be added to dehydrated the label and labeling shall bear: forage prepared from: (1) The name of the additive; and Alfalfa ...... Medicago sativa. (2) Adequate mixing directions to en- Barley ...... Hordeum vulgare. Clovers: sure that the chelated trace-mineral Alsike clover ...... Trifolium hybridum. mix is uniformly blended throughout Crimson clover ...... Trifolium incarnatum. the feed. Red clover ...... Trifolium pratense. White clover (including La- Trifolium repens. dino). § 573.380 Ethoxyquin in animal feeds. White sweetclover ...... Melilotus alba. Ethoxyquin (1,2-dihydro-6-ethoxy- Yellow sweetclover ...... Melilotus officinalis. Coastal Bermudagrass ...... Cynodon dactylon. 2,2,4-trimethylquinoline) may be safely Corn ...... Zea mays. used in animal feeds, when incor- Fescue ...... Festuca sp. porated therein in accordance with the Oats ...... Avena sativa. Orchardgrass ...... Dactylis glomerata. following prescribed conditions. Reed canarygrass ...... Pharlaris arundinacea. (a) It is intended for use only: (1) As Ryegrass (annual and peren- Elymus sp. and Lolium a chemical preservative for retarding nial). perenne. Sorghums ...... Sorghum vulgare vars, fete- oxidation of carotene, xanthophylls, rita, shallu, kaoliang, and vitamins A and E in animal feed broomcorn. and fish food and, (2) as an aid in pre- Sudan grass ...... Sorghum vulgare sudanense. venting the development of organic Wheat ...... Triticum aestivum. peroxides in canned pet food. or any mixture of such forage crops, for (b) The maximum quantity of the ad- use only as an animal feed. ditive permitted to be used and to re- (b) Such additive is used only as a main in or on the treated article shall chemical preservative for the purpose not exceed 150 parts per million. of retarding oxidative destruction of (c) To assure safe use of the additive, naturally occurring carotenes and vita- the label and labeling of the food addi- min E in the forage crops. tive container and that of any inter- (c) It is added to the dehydrated for- mediate premixes prepared therefrom age crops in an oil mixture containing 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.’’

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(2) The statement ‘‘For use in animal and equivalent crude protein from all feed only.’’ other added forms of nonprotein nitrogen shall not exceed 30 percent of the § 573.420 Ethyl cellulose. dietary crude protein. The food additive ethyl cellulose may (3) The additive may be used as fol- be safely used in animal feed in accord- lows: ance with the following prescribed con- (i) Mixed with grain, roughage, or ditions: grain and roughage prior to feeding. (a) The food additive is a cellulose (ii) As a component of free-choice liq- ether containing ethoxy (OC2H5) groups uid feeds, used to supplement the diets attached by an ether linkage and con- of cattle fed other sources of nutrients, taining on an anhydrous basis not more fermented ammoniated condensed than 2.6 ethoxy groups per whey shall not exceed 80 percent of the anhydroglucose unit. free-choice liquid feed. (b) It is used or intended for use as a (e) Labeling. The label shall bear, in binder or filler in dry vitamin prepara- addition to other information required tions to be incorporated into animal by the act: feed. (1) The name of the additive. (2) The maximum percentage of § 573.440 Ethylene dichloride. equivalent crude protein from non- The food additive ethylene dichloride protein nitrogen. may be safely used in the manufacture (3) Adequate directions for use in ac- of animal feeds in accordance with the cordance with the provisions in para- following prescribed conditions: graph (d) of this section. (a) It is used as a solvent in the ex- [43 FR 33708, July 1, 1978, as amended at 46 traction processing of animal byprod- FR 49115, Oct. 6, 1981] ucts for use in animal feeds. (b) The maximum quantity of the ad- § 573.460 Formaldehyde. ditive permitted to remain in or on the The food additive formaldehyde may extracted byproducts shall not exceed be safely used in the manufacture of 300 parts per million. animal feeds in accordance with the (c) The extracted animal byproduct is following conditions: added as a source of protein to a total (a) The additive is used, or intended ration at levels consistent with good for use, to improve the handling char- feeding practices, but in no event at acteristics of fat by producing a dry, levels exceeding 13 percent of the total free-flowing product, as follows: ration. (1) For animal fat in combination with certain oilseed meals, as a compo- § 573.450 Fermented ammoniated con- nent of dry, nonpelletted feeds for beef densed whey. and nonlactating dairy cattle. (a) Identity. The product is produced (i) An aqueous blend of soybean and by the Lactobacillus bulgaricus fer- sunflower meals in a ratio of 3:1, re- mentation of whey with the addition of spectively, is mixed with animal fat ammonia. such that the oilseed meals and animal (b) Specifications. The product con- fat are in a ratio of 3:2. The feed ingre- tains 35 to 55 percent crude protein and dients are those defined by the ‘‘Offi- not more than 42 percent equivalent cial Publication’’ of the Association of crude protein from nonprotein nitrogen American Feed Control Officials, Inc., sources. 2003 ed., pp. 303, 308, and 309, which is (c) Uses. The product is used as a incorporated by reference. The Direc- source of protein and nonprotein nitro- tor of the Office of the Federal Register gen for cattle. approves this incorporation by ref- (d) Limitations. (1) Store in a closed erence in accordance with 5 U.S.C. vented tank equipped for agitation. 552(a) and 1 CFR part 51. You may ob- Agitate 5 minutes before using. Do not tain copies from the Assistant Sec- store at temperature above 110 °F (43 retary-Treasurer, Association of Amer- °C). ican Feed Control Officials Inc., P.O. (2) The maximum level of use of fer- Box 478, Oxford, IN 47971, or you may mented ammoniated condensed whey examine a copy at the Division of

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Dockets Management, Food and Drug NARA, call 202–741–6030, or go to: http:// Administration, 5630 Fishers Lane, rm. www.archives.gov/federallregister/ 1061, Rockville, MD 20852, or at the Na- codeloflfederallregulations/ tional Archives and Records Adminis- ibrllocations.html. tration (NARA). For information on (ii) Formaldehyde (37 percent solu- the availability of this material at tion) is added to the mixture at a level NARA, call 202–741–6030, or go to: http:// of 2.7 percent of the dry matter weight www.archives.gov/federallregister/ basis of the oilseeds and/or meals and codeloflfederallregulations/ the vegetable oil. This mixture, upon ibrllocations.html. drying, contains not more than 0.5 per- (ii) Formaldehyde (37 percent solu- cent formaldehyde and not more than tion) is added to the mixture at a level 12 percent moisture. of 4 percent of the dry matter weight of (iii) To assure the safe use of the ad- the oilseed meals and animal fat. This ditive, in addition to the other infor- mixture, upon drying, contains not mation required by the act, the label more than 1 percent formaldehyde and and labeling of the dried mixture shall not more than 12 percent moisture. bear: (iii) To assure the safe use of the ad- (A) The name of the additive. ditive, in addition to the other infor- (B) The statement, ‘‘This supplement mation required by the Federal Food, is not to exceed 12.5% of the total ra- Drug, and Cosmetic Act (the act), the tion. Dietary calcium and magnesium label and labeling of the dried mixture levels should be considered when shall bear: supplementing the diet with fat.’’ (A) The name of the additive. (C) The minimum and maximum lev- (B) Adequate directions for use pro- els of crude fat must be guaranteed and viding that the feed as consumed does must be between -5 percent and +5 per- not contain more than 25 percent of the cent 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.’’

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(iv) The labeling for feed or feed in- (i) Free methyl alcohol not to exceed gredients to which formaldehyde has 1,000 parts per million (ppm); been added under the provisions of (ii) Methyl formate not to exceed paragraph (b)(1) of this section is re- 1,000 ppm; and quired to carry the following state- (iii) Moisture not to exceed 15 per- ment: ‘‘Treated with formaldehyde to cent. maintain feed Salmonella negative. Use (3) To assure safe use of the additive, within 21 days.’’ in addition to the other information re- (3) 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, the label and label- shall contain: ing shall contain: (i) The name of the additive. (i) Appropriate warnings and safety (ii) Adequate directions for use in- precautions concerning formaldehyde. cluding a statement that formic acid (ii) Statements identifying formalde- must be uniformly applied and thor- hyde as a poison with potentials for ad- oughly mixed into complete swine verse respiratory effects. feeds and that the complete swine feeds (iii) Information about emergency so treated shall be labeled as con- aid in case of accidental inhalation. taining formic acid. (iv) Statements reflecting require- (4) To assure safe use of the additive, ments of applicable sections of the in addition to the other information re- Superfund Amendments and Reauthor- quired by the Federal Food, Drug, and ization Act (SARA), and the Occupa- Cosmetic Act and paragraph (b)(3) of tional Safety and Health Administra- this section, the label and labeling tion’s (OSHA) human safety guidance shall contain: regulations. (i) Appropriate warnings and safety (v) Contact address and phone num- precautions concerning formic acid (85 ber for reporting adverse reactions or percent formic acid). to request a copy of the Materials Safe- (ii) Statements identifying formic ty Data Sheet (MSDS). acid (85 percent formic acid) as a corrosive and possible severe irritant. [41 FR 38652, Sept. 10, 1976, as amended at 54 FR 18281, Apr. 28, 1989; 61 FR 15704, Apr. 9, (iii) Information about emergency 1996; 63 FR 53580, Oct. 6, 1998; 68 FR 65633, aid in case of accidental exposure. Nov. 21, 2003] (A) Statements reflecting requirements of applicable sections of the § 573.480 Formic acid. Superfund Amendments and Reauthor- The food additive, formic acid, may ization Act (SARA), and the Occupa- be safely used in accordance with the tional Safety and Health Administra- following conditions: tion’s (OSHA) human safety guidance (a) The additive is used as a preserva- regulations. tive in hay crop silage in an amount (B) Contact address and telephone not to exceed 2.25 percent of the silage number for reporting adverse reactions on a dry weight basis or 0.45 percent or to request a copy of the Material when direct cut, as follows: Safety Data Sheet (MSDS). (1) The top foot of silage stored [76 FR 7106, Feb. 9, 2011] should not contain formic acid and (2) Silage should not be fed to live- § 573.500 Condensed, extracted glu- stock within 4 weeks of treatment. tamic acid fermentation product. (b) The additive is used or intended Condensed, extracted glutamic acid for use as a feed acidifying agent, to fermentation product may be safely lower the pH, in complete swine feeds used in animal feed under the following at levels not to exceed 1.2 percent of conditions: the complete feed. (a) The additive is a concentrated (1) The additive consists of not less mixture of the liquor remaining from than 85 percent formic acid (CAS 64–18– the extraction of glutamic acid, com- 6). bined with the cells of Corynebacterium (2) The additive meets the following lilium used to produce the glutamic specifications: acid.

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(b) It is used or intended for use as 15 percent of the total weight of the pet follows: food formulation. (1) In poultry feed as a source of pro- (e) Labeling. The labeling shall bear, tein in an amount not to exceed 5 per- in addition to other information re- cent of the total ration. quired by the Act: (2) In cattle feed as a source of pro- (1) The name of the additive. tein in an amount not to exceed 10 per- (2) Adequate directions for use in ac- cent of the feed. cordance with the provisions in para- (c) In order to assure safe use, the graph (d) of this section. label and labeling of the additive shall bear, in addition to the other informa- [45 FR 22920, Apr. 4, 1980] tion required by the Act, the following: § 573.540 Hydrolyzed leather meal. (1) The name of the additive. (2) A statement of the concentration (a) Identity. Hydrolyzed leather meal of the additive contained in any mix- is produced from leather scraps that ture. are treated with steam for not less (3) Adequate directions for use. than 33 minutes at a pressure of not less than 125 pounds per square inch. § 573.520 Hemicellulose extract. (b) Specifications. The additive shall conform to the following percent-by- Hemicellulose extract may be safely weight specifications: used in animal feed when incorporated therein in accordance with the fol- Moisture, not less than 5 percent nor more lowing conditions: than 10 percent. (a) The additive is produced from the Crude protein, not less than 60 percent. aqueous extract obtained by the treat- Crude fat, not less than 5 percent. ment of wood with water at elevated Crude fiber, not more than 6 percent. temperatures (325 degrees–535 degrees Chromium, not more than 2.75 percent. F) and pressure (80 to 900 pounds per (c) Use. It is used or intended for use square inch) and contains primarily as a source of protein in swine feeds in pentose and hexose sugars. an amount not to exceed 1.0 percent by (b) The additive may be used in a liq- weight of the finished feed. uid or dry state with the liquid product (d) Labeling. The labels and labeling containing not less than 55 percent car- shall bear, in addition to the other in- bohydrate and the dry product con- formation required by the Act: taining not less than 84 percent carbo- (1) The name of the additive, hydrate. hydrolyzed leather meal. (c) The additive is used as a source of (2) Adequate directions to provide metabolizable energy in animal feed in finished feeds complying with para- accordance with good manufacturing graph (c) of this section. and feeding practices. [41 FR 38652, Sept. 10, 1976, as amended at 43 § 573.560 Iron ammonium citrate. FR 11181, Mar. 17, 1978] Iron ammonium citrate may be safely used in animal feed in accordance § 573.530 Hydrogenated corn syrup. with the following prescribed condi- (a) Identity. The product is produced tions: by hydrogenation of corn syrup over a (a) The additive is the chemical nickel catalyst. green ferric ammonium citrate. (b) Specifications. The product con- (b) The additive is used or intended tains 70 percent hydrogenated corn for use as an anticaking agent in salt syrup and a maximum of 0.5 percent re- for animal consumption so that the ducing sugars. level of iron ammonium citrate does (c) Uses. The product is used as a hu- not exceed 25 parts per million (0.0025 mectant and plasticizer in preparation percent) in the finished salt. of soft-moist dog and cat foods. (c) To assure safe use of the additive (d) Limitations. The product is pref- the label or labeling of the additive erably stored in a closed, stainless shall bear, in addition to the other in- steel or aluminum container. The level formation required by the Act: of use of the product shall not exceed (1) The name of the additive.

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(2) Adequate directions to provide a (1) In chicken and turkey feed at a final product that complies with the level not to exceed 2 grams per ton of limitations prescribed in paragraph (b) complete feed. of this section. (2) In the feed of growing and finishing swine at a level not to exceed 10 § 573.580 Iron-choline citrate complex. grams per ton of feed. Iron-choline citrate complex made by (c) To assure safe use, the label and reacting approximately equimolecular labeling of the additive shall bear ade- quantities of ferric hydroxide, choline, quate directions for use. and citric acid may be safely used as a source of iron in animal feed. § 573.625 Menadione nicotinamide bisulfite. § 573.600 Lignin sulfonates. The food additive may be safely used Lignin sulfonates may be safely used as follows: in animal feeds in accordance with the (a) The additive is 1,2,3,4-tetrahydro- following prescribed conditions: 2-methyl-1,4-dioxo-2-naphthalene sul- (a) For the purpose of this section, fonic acid with 3-pyridine carboxylic the food additive is either one, or a acid amine (CAS No. 73581–79–0). combination of, the ammonium, cal- (b) The additive is used or intended cium, magnesium, or sodium salts of for use as a nutritional supplement for the extract of spent sulfite liquor de- both the prevention of vitamin K defi- rived from the sulfite digestion of wood ciency and as a source of supplemental or of abaca (Musa textilis) or of sisal niacin as follows: (Agave sisalana) in either a liquid form (1) In chicken and turkey feeds at a (moisture not to exceed 50 percent by level not to exceed 2 grams per ton of weight) or dry form (moisture not to complete feed. exceed 6 percent by weight). (2) In growing and finishing swine (b) It is used or intended for use in an feeds at a level not to exceed 10 grams amount calculated on a dry weight per ton of complete feed. basis, as follows: (c) To assure safe use, the label and (1) As a pelleting aid in the liquid or labeling of the additive shall bear ade- dry form in an amount not to exceed 4 quate directions for use. percent of the finished pellets. [64 FR 46840, Aug. 27, 1999] (2) As a binding aid in the liquid form in the flaking of feed grains in an § 573.637 Methyl esters of conjugated amount not to exceed 4 percent of the linoleic acid (cis-9, trans-11 and flaked grain. trans-10, cis-12-octadecadienoic (3) As a surfactant in molasses used acids). in feeds, as liquid lignin sulfonate, in The food additive, methyl esters of an amount not to exceed 11 percent of conjugated linoleic acid (cis-9, trans-11 the molasses. and trans-10, cis-12 octadecadienoic (4) As a source of metabolizable en- acids), may be safely used in swine feed ergy, in the liquid or dry form, in an in accordance with the prescribed con- amount not to exceed 4 percent of the ditions: finished feed. (a) The food additive is manufactured by the reaction of refined sunflower oil § 573.620 Menadione with methanol to produce fatty acid dimethylpyrimidinol bisulfite. methyl esters, which then undergo con- The food additive, menadione jugation to yield methyl esters of octa- dimethylpyrimidinol bisulfite, may be decadienoic acid. The additive consists safely used in accordance with the fol- of not less than 28 percent methyl ester lowing conditions: of cis-9, trans-11-octadecadienoic acid, (a) The additive is the 2-hydroxy-4,6- and not less than 28 percent methyl dimethylpyrimidinol salt of menadione ester of trans-10, cis-12-octadecadienoic (C17H18O6N2S). acid with the sum of the other methyl (b) The additive is used or intended esters of octadecadienoic acid not to for use as a nutritional supplement for exceed 4 percent. The additive shall the prevention of vitamin K deficiency contain not less than 35 percent of as follows: other fatty acid esters composed of

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oleic acid, palmitic acid, stearic acid, (3) It is free of chick-edema factor or linoleic acid, and other associated acid other factors toxic to chicks, as evi- esters. denced during the bioassay method for (b) The additive is used or intended determining the chick-edema factor as for use in the feed of growing and fin- prescribed in paragraph (b)(4)(ii) of this ishing swine as a source of fatty acids section. at levels not to exceed 0.6% in the fin- (4) For the purposes of this section: ished feed. (i) Unsaponifiable matter shall be de- (c) The additive meets the following termined by the method described in specifications: Section 28.081, ‘‘Unsaponifiable Residue (1) Free methyl alcohol not to exceed (20)—Official Final Action’’ of the ‘‘Of- 0.015%. ficial Methods of Analysis of the Asso- (2) Insoluble impurities not to exceed ciation of Official Analytical Chem- 0.1%. ists,’’ 13th Ed., 1980, p. 451, which is in- (3) Moisture not to exceed 0.5%. corporated by reference. Copies are (4) Unsaponifiable matter not to ex- available from the AOAC INTER- ceed 1.0%. NATIONAL, 481 North Frederick Ave., (d) To assure safe use of the additive, suite 500, Gaithersburg, MD 20877, or in addition to the other information re- available for inspection at the National quired by the act: Archives and Records Administration (1) The label and labeling of the addi- (NARA). For information on the avail- tive and any feed premix shall bear the ability of this material at NARA, call following: 202–741–6030, or go to: http:// (i) The name of the additive. www.archives.gov/federallregister/ (ii) A statement to indicate that codeloflfederallregulations/ methyl esters of conjugated linoleic ibrllocations.html. acid (cis-9, trans-11 and trans-10, cis-12 (ii) The chick-edema factor bioassay octadecadienoic acids) must not be method described under ‘‘26. Oils, Fats, added to vitamin or mineral premixes. and Waxes’’ in the Journal of the Asso- (2) The label and labeling of the addi- ciation of Official Agricultural Chemists, tive, any feed premix, or complete feed Vol. 44, Page 146 (1961), or the method prepared therefrom shall bear adequate described under ‘‘Chick-Edema Fac- directions for use. tor—Bioassay Method (34)—Official [73 FR 64198, Oct. 29, 2008] Final Action’’ in §§ 28.113–28.117, ‘‘Offi- cial Methods of Analysis of the Asso- § 573.640 Methyl esters of higher fatty ciation of Official Analytical Chem- acids. ists,’’ 12th Ed., 1975, pp. 509–511, which The food additive methyl esters of is incorporated by reference, shall be higher fatty acids may be safely used employed. (Copies of the methods are in animal feeds in accordance with the available from the AOAC INTER- following prescribed conditions: NATIONAL, 481 North Frederick Ave., (a) The food additive is manufactured suite 500, Gaithersburg, MD 20877, or by reaction of methyl alcohol with available for inspectionat the National feed-grade fats or oils and consists of Archives and Records Administration not less than 70 percent methyl esters (NARA). For information on the avail- of the following straight-chain ability of this material at NARA, call monocarboxylic acids: Docosahexanoic 202–741–6030, or go to: http:// acid, eicosapentanoic acid, linoleic www.archives.gov/federallregister/ acid, myristic acid, oleic acid, palmitic codeloflfederallregulations/ acid, palmitoleic acid, and stearic acid, ibrllocations.html. ) The presence of and lesser amounts of the associated chick-edema factor shall be determined acid esters. by a comparison between the mean log (b) The food additive meets the fol- of the pericardial fluid volumes of a lowing specifications: test group and of a concurrent negative (1) Free methyl alcohol not to exceed control group. The significance of the 150 parts per million. difference in pericardial fluid volumes (2) Unsaponifiable matter not to ex- between the test group and the nega- ceed 2 percent. tive control group is determined by

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calculating a ‘‘t’’ value according to therefrom shall bear adequate direc- the formula: tions for use. xx− [41 FR 38652, Sept. 10, 1976, as amended at 47 t = tc FR 9397, Mar. 5, 1982; 54 FR 18281, Apr. 28, 22+ 1989; 70 FR 40880, July 15, 2005; 70 FR 67651, ()sntt//() sn cc Nov. 8, 2005] where: § 573.660 Methyl glucoside-coconut oil x¯ t and x¯ c are the means of the logs of the ester. pericardial fluid volumes of the test and control groups, respectively; Methyl glucoside-coconut oil ester nt and nc are the number of chicks in the re- may be safely used in accordance with spective groups; the following conditions: 2 2 st and sc are the variances of the test and (a) The additive meets the specifica- control groups, respectively. tions prescribed in § 172.816 of this The variances are calculated as follows: chapter. (b) It is used as a surfactant in mo- nx()(∑−∑22 x) s2 = lasses intended for use in animal feed − at a level not to exceed 320 parts per nn( 1) million. where: Sx is the sum of the logs of the pericardial § 573.680 Mineral oil. fluid volumes; Mineral oil may be safely used in ani- Sx2 is the sum of the squares of the logs of the pericardial fluid volumes for either mal feed, subject to the provisions of the test t or control c group data. this section. (a) Mineral oil, for the purpose of this The test sample is judged to contain section, is that complying with the def- chick-edema factor if the calculated inition and specifications contained in ‘‘t’’ exceeds +1.3 and the mean log of § 172.878 (a) and (b) or in § 178.3620(b)(1) the pericardial fluid volume obtained (i) and (ii) of this chapter. from the negative control group multi- (b) It is used in animal feeds for the plied by 100 is less than 1.1461. following purposes: (iii) ‘‘Other factors toxic to chicks’’ (1) To reduce dustiness of feeds or referred to in paragraph (b)(3) of this mineral supplements. section shall be determined during the (2) To serve as a lubricant in the course of the bioassay test described in preparation of pellets, cubes, or blocks paragraph (b)(4)(ii) of this section, on and to improve resistance to moisture the basis of chick deaths or other ab- of such pellets, cubes, or blocks. normalities not attributable to chick- (3) To prevent the segregation of edema factor or to the experimental trace minerals in mineralized salt. conditions of the test. (4) To serve as a diluent carrier in (c) It is used or intended for use as a the manufacture of feed grade biuret in supplementary source of fat for animal accordance with good manufacturing feed. practice. (d) To assure safe use of the additive, (5) For the removal of water from in addition to the other information re- substances intended as ingredients of quired by the act: animal feed. (1) The label and labeling of the addi- (c) The quantity of mineral oil used tive, and any feed additive supplement, in animal feed shall not exceed 3.0 per- feed additive concentrate, feed additive cent in mineral supplements, nor shall premix, or complete feed prepared it exceed 0.06 percent of the total ra- therefrom shall bear: tion when present in feed or feed con- (i) The name of the additive. centrates. (ii) The designation ‘‘feed grade’’ in juxtaposition with the name and equal- [41 FR 38652, Sept. 10, 1976, as amended at 47 ly as prominent. FR 41106, Sept. 17, 1982] (2) The label or labeling of the additive and any feed additive supplement, § 573.685 Natamycin. feed additive concentrate, feed additive The food additive natamycin (CAS premix, or complete feed prepared No. 7681–93–8) may be safely used in

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broiler chicken feeds in accordance copy of the Material Safety Data Sheet with the following specifications: for natamycin. (a) The additive is a stereoisomer of [69 FR 19321, Apr. 13, 2004] 22-[(3-amino-3,6,dideoxy-b-D- mannopyranosyl)oxy]-1,3,26- § 573.700 Sodium nitrite. trihydroxy-12-methyl-10-oxo-6,11,28- Sodium nitrite may be safely used in trioxatricyclo[22.3.1.05, 7] octacosa- canned pet food containing meat and 8,14,16,18,20-pentaene-25-carboxylic acid fish in accordance with the following with the empirical formula C H NO 33 47 13. prescribed conditions: (b) The additive shall conform to (a) It is used or intended for use U.S.P. specifications. alone as a preservative and color fixa- (c) The additive (as part of a premix tive in canned pet food containing fish, composed of calcium carbonate, meat, and fish and meat byproducts so natamycin, and lactose) is used for re- that the level of sodium nitrite does tarding the growth of Aspergillus not exceed 20 parts per million. in broiler chicken feeds for parasiticus (b) To assure safe use of the additive, up to 14 days after the addition of in addition to the other information re- natamycin. quired by the act: (d) Each pound (454 grams (g)) of the (1) The label of the additive shall premix shall contain 434 (g) of calcium bear: carbonate, 10 g of natamycin activity, (i) The name of the additive. and 10 g of lactose. The premix shall be (ii) A statement of the concentration mixed into broiler chicken feed at the of the additive in any mixture. rate of 1 pound (0.454 kilograms (kg)) (2) The label or labeling shall bear per ton (908 kg) of feed to provide adequate directions to provide a final natamycin at a level of 11 parts per product that complies with the limita- million (ppm). The premix shall be tions prescribed in paragraph (a) of this thoroughly mixed into the dry compo- section. nents of the broiler chicken feed before adding the liquid components. Broiler § 573.720 Petrolatum. feeds to which the natamycin premix is Petrolatum may be safely used in or added shall be used within 4 weeks of on animal feed, subject to the fol- addition of the premix. lowing prescribed conditions: (e) To assure the safe use of the addi- (a) Petrolatum complies with the tive, the label or labeling of the addi- specifications set forth in the U.S. tive shall bear, in addition to other in- Pharmacopeia XVI for white petro- formation required by the Federal latum or in The National Formulary Food, Drug, and Cosmetic Act, the fol- XII for yellow petrolatum. lowing: (b) Petrolatum meets the following (1) The name and CAS number of the ultraviolet absorbance limits when additive, and its purpose. subjected to the analytical procedure (2) A listing of ingredients consisting described in § 172.886(b) of this chapter. of calcium carbonate, the additive, and lactose and their proportions in the Ultraviolet absorbance per centimeter premix as prescribed under paragraph path length: (d) of this section. Millimicrons Maximum (3) Adequate directions for use to ensure a broiler chicken feed that is in 280 to 289 ...... 0.25 290 to 299 ...... 20 compliance with the limitations pre- 300 to 359 ...... 14 scribed in paragraph (d) of this section. 360 to 400 ...... 04 (4) An appropriate cautionary statement: ‘‘Caution: Store in a tightly- (c) It is used in animal feed for the closed, light-resistant container in a following purposes: cool, dry place.’’ (1) To reduce dustiness of feeds or (5) An expiration date of 1 year from mineral supplements. the date of manufacture. (2) To serve as a lubricant in the (6) A contact address and telephone preparation of pellets, cubes, or blocks, number for reporting adverse reactions and to improve resistance to moisture experienced by users, or to request a of such pellets, cubes, or blocks.

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(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. (3) Crude fiber, not more than 2 per- (2) The polyethylene is designed in a cent. pellet form in a configuration pre- (4) Ash, not more than 13 percent. senting maximum angular surface having the following dimensions in centi- (5) Moisture, not more than 6 per- meters: cent. (c) Use. To ensure safe use, the label- 0.9 ±0.1 × 0.8 ±0.1 × 1.2 ±0.1 ing of the additive and any feed addi- (c) Use. It is used as a replacement tive supplement, concentrate, or pre- for roughage in feedlot rations for fin- mix prepared therefrom shall bear, in ishing slaughter cattle. addition to other required information, (d) Labeling. The labels and labeling the name of the additive, directions for shall bear in addition to the other in- use to provide not more than 10 percent formation required by the Act: by weight of the total ration, and the (1) The name of the additive ‘‘poly- statement ‘‘Caution: Not to be used in ethylene roughage replacement.’’

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(2) Adequate directions for use which for beef cattle and dairy cattle and re- shall provide for the administration of placement dairy heifers when used in one-half pound of polyethylene pellets accordance with the following condi- per head per day for 6 successive days. tions: All natural roughage should be re- (a) The additive meets the following moved for a minimum of 12 hours prior specifications: to administration of polyethylene roughage replacement. Roughage re- Component/property Limitation placement must be adequately mixed Inherent viscosity ...... 1.0-1.6 deciliter per gram.1 in the ration for uniform distribution. Styrene moiety ...... 40 percent maximum. 2-Vinylpyridine moiety...... 90 percent maximum. [41 FR 38652, Sept. 10, 1976, as amended at 54 Residual styrene ...... 200 parts per billion max- FR 18282, Apr. 28, 1989] imum. Residual 2-vinylstyrene ...... 200 parts per billion maximum. § 573.800 Polyethylene glycol (400) Heavy metals such as lead .... 10 parts per million max- mono- and dioleate. imum. (a) The food additive polyethylene Arsenic ...... 3 parts per million maximum. glycol (400) mono- and dioleate meets 1 Inherent viscosity of a 0.25 percent (weight/volume) solu- the following specifications: Saponi- tion in dimethylformamide. fication number, 80–88; acid number, 5.0 (b) The additive is used in the manu- maximum; and average molecular facture of rumen-stable, abomasum- weight range, 640–680. dispersible nutrient(s) for beef cattle (b) It is used as a processing aid in and dairy cattle and replacement dairy the production of animal feeds when heifers such that the maximum use of present as a result of its addition to the additive from all sources does not molasses in an amount not to exceed exceed 5.1 grams per head per day. The 250 parts per million of the molasses. additive may be used to protect the following nutrients: § 573.820 Polyoxyethylene glycol (400) (1) Methionine. The resulting product mono- and dioleates. must contain a maximum of 10 percent The food additive polyoxyethylene poly(2-vinylpyridine-co-styrene) by glycol (400) mono- and dioleates may be weight and a minimum of 55 percent safely used as an emulsifier in calf- methionine by weight. The coated me- milk replacer formulations. thionine must be established through in vitro tests to be at least 90 percent § 573.840 Polysorbate 60. rumen-stable, of which at least 90 per- The food additive polysorbate 60 cent is subsequently dispersible under (polyoxyethylene (20) sorbitan mono- abomasal conditions. stearate) may be safely used in animal (2) Methionine and lysine. The result- feeds in accordance with the following ing product must contain a maximum prescribed conditions: of 10 percent poly(2-vinylpyridine-co- (a) It is used alone or in combination styrene) by weight and a minimum of a with sorbitan monostearate as an combined total of 55 percent methio- emulsifier in mineral premixes and die- nine and lysine by weight. The coated tary supplements for animal feeds. methionine and lysine must be estab- (b) It is used as an emulsifier in milk- lished through in vitro tests to be at replacer formulations for calves. least 90 percent rumen-stable, of which at least 90 percent is subsequently dis- § 573.860 Polysorbate 80. persible under abomasal conditions. The food additive polysorbate 80 (c) Label and labeling. To ensure safe (polyoxyethylene (20) sorbitan use of the additive, the label and label- monooleate) may be safely used as an ing of the additive and of any feed addi- emulsifier in milk-replacer formula- tive supplement, feed additive con- tions for calves. centrate, feed additive premix, or liquid feed supplement prepared there- § 573.870 Poly(2-vinylpyridine-co-sty- from, shall bear, in addition to the rene). other information required by the Fed- The food additive poly(2- eral Food, Drug, and Cosmetic Act, the vinylpyridine-co-styrene) may be safe- following: ly used as nutrient protectant in feed (1) The name of the additive.

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(2) A statement of the concentration Components Amount of poly(2-vinylpyridine-co-styrene) in any product or mixture. Calcium salts of mixed 5-carbon 58 to 72 percent. acids (as identified in paragraph (3) Adequate directions for the use of (a) of this section). the rumen-stable, abomasum-dispers- Calcium salt of isobutyric acid ...... 26 to 34 percent. ible nutrient(s) products. Calcium hydroxide ...... 3 percent maximum. (4) The following statement: ‘‘Warn- Water ...... 14 percent maximum. Arsenic ...... 3 parts per million max- ing: Maximum use of poly(2- imum. vinylpyridine-co-styrene) from all Heavy metals such as lead ...... 10 parts per million max- sources is not to exceed 5.1 grams per imum. 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 § 573.880 Normal propyl alcohol. the additive in any feed, feed supplement, 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 volatile fatty acids and shall conform the 1987 amendments and any modifica- to the following specifications: tion of such rule issued after enact- (1) Ammonium salts: ment of the 1994 Act; unless the Com- Components Amount missioner of Food and Drugs makes a determination that: Ammonium salts of mixed 5-car- 48 to 54 percent. (1) Selenium additives are not essen- bon acids (as identified in para- tial at levels authorized in the absence graph (a) of this section). Ammonium salt of isobutyric acid 22 to 26 percent. of such final rule, to maintain animal Water ...... 28 percent maximum. nutrition and protect animal health; Ammonia ...... 0.3 percent maximum. (2) selenium at such levels is not safe Arsenic ...... 3 parts per million max- to the animals consuming the additive; imum. Heavy metals such as lead ...... 10 parts per million max- (3) selenium at such levels is not safe imum. to individuals consuming edible portions of animals that receive the addi- (2) Calcium salts: tive;

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(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 or in a controlled-release sodium sele- (g) The additive is orally adminis- nite bolus, as provided in paragraphs (f) tered to beef and dairy cattle as an os- and (g) of this section, or as selenium motically controlled, constant release yeast, as provided in paragraph (h) of bolus containing sodium selenite. Each this section. bolus contains 360 milligrams of sele- (c) It is added to feed as follows: nium as sodium selenite, and delivers 3 (1) In complete feed for chickens, milligrams of selenium per day for 120 swine, turkeys, sheep, cattle, and days. To ensure safe use of the addi- ducks at a level not to exceed 0.3 part tive: per million. (1) The osmotically controlled, con- (2) In feed supplements for limit feed- stant release bolus is for use only in ing as follows: beef and dairy cattle more than 3 (i) Sheep: At a level not to exceed an months of age or over 200 pounds body intake of 0.7 milligram per head per weight. day. (2) Only one bolus containing 360 mil- (ii) Beef cattle: At a level not to ex- ligrams of selenium as sodium selenite ceed an intake of 3 milligrams per head is administered orally to each animal per day. in 120 days. (3) In salt-mineral mixtures for free- (3) The labeling shall bear the fol- choice feeding as follows: lowing: ‘‘This bolus delivers the max- (i) Sheep: Up to 90 parts per million in imum daily allowable amount of sele- a mixture for free-choice feeding at a nium and shall be the sole source of rate not to exceed an intake of 0.7 mil- supplementation. Do not use in areas ligram per head per day. containing excess selenium. Do not (ii) Beef cattle: Up to 120 parts per rebolus within 4 months.’’ million in a mixture for free-choice feeding at a rate not to exceed an in- (h) Selenium yeast is a dried, non- take of 3 milligrams per head per day. viable yeast (Saccharomyces cerevisiae) (d) The additive shall be incorporated cultivated in a fed-batch fermentation into feed as follows: which provides incremental amounts of (1) It shall be incorporated into each cane molasses and selenium salts in a ton of complete feed by adding no less manner which minimizes the detri- than 1 pound of a premix containing no mental effects of selenium salts on the more than 272.4 milligrams of added se- growth rate of the yeast and allows for lenium per pound. optimal incorporation of inorganic se- (2) It shall be incorporated into each lenium into cellular organic material. ton of salt-mineral mixture for sheep Residual inorganic selenium is elimi- or beef cattle from a premix containing nated in a rigorous washing process no more than 4.5 grams of added sele- and must not exceed 2 percent of the nium per pound. total selenium content in the final se- (e) The premix manufacturer shall lenium yeast product. follow good manufacturing practices in (1) Selenium, as selenium yeast, is the production of selenium premixes. added to feed as follows:

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(i) In complete feed for chickens, tur- Feed component Limitations keys, swine, beef cattle, and dairy cat- (percent) tle at a level not to exceed 0.3 part per BHT (butylated hydroxytoluene) ...... 2 million. Methionine hydroxy analog and its calcium salts 1 (ii) In feed supplements for limit Piperazine, piperazine salts ...... 0.8 feeding for beef cattle at a level not to Sodium propionate ...... 1 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 content from selenium yeast must be de- § 573.960 Sorbitan monostearate. clared on the selenium yeast product The food additive sorbitan monostea- label. rate may be safely used alone or in (3) The additive, as selenium yeast, combination with polysorbate 60 as an shall be incorporated into feed as fol- emulsifier in mineral premixes and die- lows: tary supplements for animal feeds. (i) It shall be incorporated into each ton of complete feed by adding no less § 573.980 Taurine. than 1 pound of a premix containing no The food additive taurine (2-amino- more than 272.4 milligrams of added se- ethanesulfonic acid) may be safely used lenium per pound. in feed in accordance with the fol- (ii) It shall be incorporated into each lowing prescribed conditions: ton of salt-mineral mixture for beef (a) It is used as a nutritional supple- cattle from a premix containing no ment in the feed of growing chickens. more than 4.5 grams of added selenium (b) It is added to complete feeds so per pound. that the total taurine content does not (4) Usage of this additive must con- exceed 0.054 percent of the feed. form to the requirements of paragraphs (c) To assure safe use of the additive, (e) and (f) of this section. the label and labeling shall bear in ad- [52 FR 10888, Apr. 6, 1987; 52 FR 21001, June 4, dition to the other information re- 1987, as amended at 54 FR 14215, Apr. 10, 1989; quired by the Act: 54 FR 15874, Apr. 19, 1989; 60 FR 53703, Oct. 17, (1) The name of the additive. 1995; 65 FR 35824, June 6, 2000; 65 FR 53167, (2) The quantity of the additive con- Sept. 1, 2000; 67 FR 46851, July 17, 2002; 68 FR tained therein. 52340, Sept. 3, 2003; 72 FR 39561, July 19, 2007] (3) Adequate directions for use. EFFECTIVE DATE NOTE: At 58 FR 47973, Sept. 13, 1993, the amendments to § 573.920 § 573.1000 Verxite. that were published at 52 FR 10887, Apr. 6, 1987; 52 FR 21001, June 4, 1987; and 54 FR The food additive verxite may be 14214, Apr. 10, 1989 were stayed until further safely used in animal feed in accord- notice. At 59 FR 45973, Sept. 6, 1994, the stay ance with the following prescribed con- was confirmed. ditions: (a) The additive is a magnesium-alu- § 573.940 Silicon dioxide. minum-iron silicate conforming to one The food additive silicon dioxide may of the following: be safely used in animal feed in accord- (1)(i) Verxite granules: The additive ance with the following conditions: contains a minimum of 98 percent of (a) The food additive is manufactured hydrobiotite; it is thermally expanded by vapor phase hydrolysis or by other and has a bulk density of from 5 to 9 means whereby the particle size is such pounds per cubic foot. as to accomplish the intended effect. (ii) It is used or intended for use: (b) It is used or intended for use in (a) In poultry feed at a level not to feed components as an anticaking exceed 5 percent of the weight of the agent, and/or grinding aid, as follows: finished feed as a nonnutritive bulking

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agent for restricting calorie intake in (1) In calf milk replacers at a max- pullet replacement feeds. imum use level of 0.1 percent, as fed. (b) As an anticaking or blending (2) In liquid feed supplements for ru- agent, pelleting aid, or nonnutritive minant animals at a maximum use carrier for the incorporation of nutri- level of 0.25 percent (5 pounds per ton). ents in poultry, swine, dog, or rumi- (c) To assure safe use of the additive: nant feeds, in an amount not to exceed (1) The label of its container shall that necessary to accomplish its in- bear, in addition to other information tended effect and in no case to exceed required by the act, the name of the 1.5 percent of the dog feed or 5 percent additive. of the final feed for other animals. (2)(i) Verxite flakes: The additive (2) The label or labeling of the addi- contains a minimum of 98 percent of tive container shall bear adequate di- hydrobiotite; it has a bulk density of rections for use. from 20 to 30 pounds per cubic foot. [49 FR 44630, Nov. 8, 1984] (ii) It is used or intended for use as an anticaking or blending agent in ru- § 573.1020 Yellow prussiate of soda. minant feeds in an amount not to exceed that necessary to accomplish its Yellow prussiate of soda (sodium fer- ° intended effect and in no case to exceed rocyanide decahydrate: Na4Fe(Cn)6 - 1 percent by weight of the final feed for 10H2O) may be safely used as an ruminants. 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 drate. partial roughage replacement in rumi- [41 FR 38657, Sept. 10, 1976; 41 FR 48100, Nov. nant feeds in an amount not to exceed 2, 1976] that necessary to accomplish its intended effect and in no case to exceed 1 percent by weight of the final feed. PART 579—IRRADIATION IN THE (b) To assure safe use of the additive, PRODUCTION, PROCESSING, the label of any feed additive supple- AND HANDLING OF ANIMAL ment, feed additive concentrate, feed FEED AND PET FOOD additive premix, or complete feed prepared therefrom shall bear, in addition Subpart A—General Provisions to the other information required by the Act, the name of the additive Sec. (verxite granules, verxite flakes, or 579.12 Incorporation of regulations in part verxite grits), adequate directions for 179. use, and, when the additive is present in excess of 1 percent, a statement of Subpart B—Radiation and Radiation the quantity of the additive contained Sources therein and the term ‘‘nonnutritive’’ in 579.22 Ionizing radiation for treatment of juxtaposition therewith. animal diets. 579.40 Ionizing radiation for the treatment § 573.1010 Xanthan gum. of poultry feed and poultry feed ingredi- The food additive xanthan gum may ents. be safely used in animal feed as fol- AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 371. lows: (a) The food additive is xanthan gum as defined in § 172.695 of this chapter Subpart A—General Provisions and meets all of the specifications thereof. § 579.12 Incorporation of regulations (b) It is used or intended for use as a in part 179. stabilizer, emulsifier, thickener, sus- Regulations providing for irradiation pending agent, or bodying agent in ani- in the production, processing, and han- mal feed as follows: dling of food in part 179 of this chapter

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are incorporated in subchapter E as ap- (1) Gamma rays from sealed units of plicable to use in the production, proc- cobalt-60 or cesium-137; essing, handling, and labeling of ani- (2) Electrons generated from machine mal feed and pet food, except where sources at energy levels not to exceed specifically provided for in this part. 10 million electron volts (MeV); (3) X-rays generated from machine [51 FR 5993, Feb. 19, 1986] sources at energies not to exceed 5 MeV, except as permitted by Subpart B—Radiation and § 179.26(a)(4) of this chapter; or Radiation Sources (4) X-rays generated from machine sources using tantalum or gold as the § 579.22 Ionizing radiation for treat- target material and using energies not ment of animal diets. to exceed 7.5 MeV. Ionizing radiation for treatment of (b) Limitation. The ionizing radiation complete diets for animals may be is used for feed or feed ingredients that safely used under the following condi- do not contain drugs. tions: (c) Use. Ionizing radiation is used as (a) Energy sources. Ionizing radiation a single treatment for rendering com- is limited to: plete poultry diets or poultry feed in- (1) Gamma rays for sealed units of gredients salmonella negative as fol- the radionuclides cobalt-60 or cesium- lows: 137. (1) Minimum dose 2.0 kiloGrays (kGy) (2) Electrons generated from machine (0.2 megarad (Mrad)); maximum dose 25 sources at energy levels not to exceed kGy (2.5 megarads Mrad). The absorbed 10 million electron volts. dose of irradiation is to be based on ini- (b) Uses. (1) The ionizing radiation is tial concentration of salmonella using used or intended for use in single treat- the relationship that 1.0 kGy (0.1 Mrad) ment as follows: reduces salmonella concentration by one log cycle (one decimal reduction). Food for irradiation Limitations Use (2) Feeds treated by irradiation Bagged complete Absorbed dose: Microbial disinfec- should be formulated to account for diets, packaged Not to exceed tion, control or nutritional loss. feeds, feed ingre- 50 kiloGrays. elimination (3) If an irradiated feed ingredient is dients, bulk feeds, Feeds and animal treats and feed ingredi- less than 5 percent of the final product, chews. ents treated the final product can be irradiated by irradiation without being considered to be re- should be formulated to irradiated. account for [60 FR 50099, Sept. 28, 1995, as amended at 78 nutritional loss. FR 27304, May 10, 2013; 78 FR 34565, June 10, 2013] (2) If an irradiated feed ingredient is less than 5 percent of the final product, PART 582—SUBSTANCES the final product can be irradiated GENERALLY RECOGNIZED AS SAFE without being considered to be re-irradiated. Subpart A—General Provisions [51 FR 5993, Feb. 19, 1986; 51 FR 8315, Mar. 11, Sec. 1986, as amended at 58 FR 18148, Apr. 8, 1993; 582.1 Substances that are generally recog- 66 FR 18540, Apr. 10, 2001] nized as safe. 582.10 Spices and other natural seasonings § 579.40 Ionizing radiation for the and flavorings. treatment of poultry feed and poul- 582.20 Essential oils, oleoresins (solvent- try feed ingredients. free), and natural extractives (including Ionizing radiation for the treatment distillates). of complete poultry diets and poultry 582.30 Natural substances used in conjunction with spices and other natural feed ingredients may be safely used as seasonings and flavorings. follows: 582.40 Natural extractives (solvent-free) (a) Energy sources. Ionizing radiation used in conjunction with spices, is limited to: seasonings, and flavorings.

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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. adjuvants. 582.1748 Sodium caseinate. 582.80 Trace minerals added to animal feeds. 582.1751 Sodium citrate. 582.99 Adjuvants for pesticide chemicals. 582.1763 Sodium hydroxide. 582.1775 Sodium pectinate. Subpart B—General Purpose Food 582.1778 Sodium phosphate. Additives 582.1781 Sodium aluminum phosphate. 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. 582.1091 Succinic acid. 582.2122 Aluminum calcium silicate. 582.1095 Sulfuric acid. 582.2227 Calcium silicate. 582.1099 Tartaric acid. 582.2437 Magnesium silicate. 582.1125 Aluminum sulfate. 582.2727 Sodium aluminosilicate. 582.1127 Aluminum ammonium sulfate. 582.2729 Hydrated sodium calcium 582.1129 Aluminum potassium sulfate. aluminosilicate. 582.1131 Aluminum sodium sulfate. 582.2906 Tricalcium silicate. 582.1135 Ammonium bicarbonate. 582.1137 Ammonium carbonate. Subpart D—Chemical Preservatives 582.1139 Ammonium hydroxide. 582.3013 Ascorbic acid. 582.1141 Ammonium phosphate. 582.3021 Benzoic acid. 582.1143 Ammonium sulfate. 582.3041 Erythorbic acid. 582.1155 Bentonite. 582.3081 Propionic acid. 582.1165 Butane. 582.3089 Sorbic acid. 582.1191 Calcium carbonate. 582.3109 Thiodipropionic acid. 582.1193 Calcium chloride. 582.3149 Ascorbyl palmitate. 582.1195 Calcium citrate. 582.3169 Butylated hydroxyanisole. 582.1199 Calcium gluconate. 582.3173 Butylated hydroxytoluene. 582.1205 Calcium hydroxide. 582.3189 Calcium ascorbate. 582.1207 Calcium lactate. 582.3221 Calcium propionate. 582.1210 Calcium oxide. 582.3225 Calcium sorbate. 582.1217 Calcium phosphate. 582.3280 Dilauryl thiodipropionate. 582.1235 Caramel. 582.3336 Gum guaiac. 582.1240 Carbon dioxide. 582.3490 Methylparaben. 582.1275 Dextrans. 582.3616 Potassium bisulfite. 582.1320 Glycerin. 582.3637 Potassium metabisulfite. 582.1324 Glyceryl monostearate. 582.3640 Potassium sorbate. 582.1355 Helium. 582.3660 Propyl gallate. 582.1366 Hydrogen peroxide. 582.3670 Propylparaben. 582.1400 Lecithin. 582.3731 Sodium ascorbate. 582.1425 Magnesium carbonate. 582.3733 Sodium benzoate. 582.1428 Magnesium hydroxide. 582.3739 Sodium bisulfite. 582.1431 Magnesium oxide. 582.3766 Sodium metabisulfite. 582.1480 Methylcellulose. 582.3784 Sodium propionate. 582.1500 Monoammonium glutamate. 582.3795 Sodium sorbate. 582.1516 Monopotassium glutamate. 582.3798 Sodium sulfite. 582.1540 Nitrogen. 582.3845 Stannous chloride. 582.1585 Papain. 582.3862 Sulfur dioxide. 582.1613 Potassium bicarbonate. 582.3890 Tocopherols. 582.1619 Potassium carbonate. 582.1625 Potassium citrate. Subpart E—Emulsifying Agents 582.1631 Potassium hydroxide. 582.1643 Potassium sulfate. 582.4101 Diacetyl tartaric acid esters of 582.1655 Propane. mono- and diglycerides of edible fats or 582.1666 Propylene glycol. oils, or edible fat-forming fatty acids. 582.1685 Rennet. 582.4505 Mono- and diglycerides of edible 582.1711 Silica aerogel. fats or oils, or edible fat-forming acids.

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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. 582.5304 Ferric pyrophosphate. 582.6195 Calcium citrate. 582.5306 Ferric sodium pyrophosphate. 582.6197 Calcium diacetate. 582.5308 Ferrous gluconate. 582.6199 Calcium gluconate. 582.5311 Ferrous lactate. 582.6203 Calcium hexametaphosphate. 582.5315 Ferrous sulfate. 582.6215 Monobasic calcium phosphate. 582.5361 Histidine. 582.6219 Calcium phytate. 582.5370 Inositol. 582.6285 Dipotassium phosphate. 582.5375 Iron reduced. 582.6290 Disodium phosphate. 582.5381 Isoleucine. 582.6386 Isopropyl citrate. 582.5406 Leucine. 582.6511 Monoisopropyl citrate. 582.5411 Lysine. 582.6625 Potassium citrate. 582.5431 Magnesium oxide. 582.6751 Sodium citrate. 582.5434 Magnesium phosphate. 582.6754 Sodium diacetate. 582.5443 Magnesium sulfate. 582.6757 Sodium gluconate. 582.5446 Manganese chloride. 582.6760 Sodium hexametaphosphate. 582.5449 Manganese citrate. 582.6769 Sodium metaphosphate. 582.5452 Manganese gluconate. 582.6778 Sodium phosphate. 582.5455 Manganese glycerophosphate. 582.6787 Sodium pyrophosphate. 582.5458 Manganese hypophosphite. 582.6789 Tetra sodium pyrophosphate. 582.5461 Manganese sulfate. 582.6801 Sodium tartrate. 582.5464 Manganous oxide. 582.6804 Sodium potassium tartrate. 582.5470 Mannitol. 582.6807 Sodium thiosulfate. 582.5475 Methionine. 582.6810 Sodium tripolyphosphate. 582.5477 Methionine hydroxy analog and its 582.6851 Stearyl citrate. calcium salts. 582.5530 Niacin. Subpart H—Stabilizers 582.5535 Niacinamide. 582.5580 D-Pantothenyl alcohol. 582.7115 Agar-agar. 582.5590 Phenylalanine. 582.7133 Ammonium alginate. 582.5622 Potassium chloride. 582.7187 Calcium alginate. 582.5628 Potassium glycerophosphate. 582.7255 Chondrus extract. 582.5634 Potassium iodide. 582.7330 Gum arabic. 582.5650 Proline. 582.7333 Gum ghatti. 582.5676 Pyridoxine hydrochloride. 582.7339 Guar gum. 582.5695 Riboflavin. 582.7343 Locust bean gum. 582.5697 Riboflavin-5-phosphate. 582.7349 Sterculia gum. 582.5701 Serine. 582.7351 Gum tragacanth.

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582.7610 Potassium alginate. food ingredient. Upon request the Com- 582.7724 Sodium alginate. missioner will offer an opinion, based AUTHORITY: 21 U.S.C. 321, 342, 348, 371. on specifications and intended use, as SOURCE: 41 FR 38657, Sept. 10, 1976, unless to whether or not a particular grade or otherwise noted. lot of the substance is of suitable purity for use in food and would generally Subpart A—General Provisions be regarded as safe for the purpose intended, by experts qualified to evaluate § 582.1 Substances that are generally its safety. recognized as safe. (c) The inclusion of substances in the (a) It is impracticable to list all sub- list of nutrients does not constitute a stances that are generally recognized finding on the part of the Department as safe for their intended use. However, that the substance is useful as a sup- by way of illustration, the Commis- plement to the diet for animals. sioner regards such common food in- (d) Substances that are generally rec- gredients as salt, pepper, sugar, vin- ognized as safe for their intended use egar, baking powder, and monosodium within the meaning of section 409 of glutamate as safe for their intended the Act are listed in subparts B use. The lists in subparts B through H of this part include additional sub- through H of this part. When the status stances that, when used for the pur- of a substance has been reevaluated poses indicated, in accordance with and affirmed as GRAS or deleted from good manufacturing or feeding prac- subparts B through H of this part, an tice, are regarded by the Commissioner appropriate explanation will be noted, as generally recognized as safe for such e.g., ‘‘affirmed as GRAS,’’ ‘‘food addi- uses. tive regulation,’’ ‘‘interim food addi- (b) For the purposes of this section, tive regulation,’’ or ‘‘prohibited from good manufacturing or feeding practice use in food,’’ with a reference to the shall be defined to include the fol- appropriate new regulation. Such nota- lowing restrictions: tion will apply only to the specific use (1) The quantity of a substance added covered by the review, e.g., direct ani- to animal food does not exceed the mal food use and/or indirect animal amount reasonably required to accom- food use and/or animal feed use and plish its intended physical, nutritional, will not affect its status for other uses or other technical effect in food; and not specified in the referenced regula- (2) The quantity of a substance that tion, pending a specific review of such becomes a component of animal food as a result of its use in the manufac- other uses. turing, processing, or packaging of § 582.10 Spices and other natural food, and which is not intended to ac- seasonings and flavorings. complish any physical or other technical effect in the food itself, shall be Spices and other natural seasonings reduced to the extent reasonably pos- and flavorings that are generally rec- sible. ognized as safe for their intended use, (3) The substance is of appropriate within the meaning of section 409 of grade and is prepared and handled as a the act, are as follows:

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.

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Common name Botanical name of plant source

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. 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.

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Common name Botanical name of plant source

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. 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.

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Common name Botanical name of plant source

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. 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.

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Common name Botanical name of plant source

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.

§ 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.

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Common name Botanical name of plant source

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 1-Malic acid. and adjuvants. Methyl anthranilate (methyl-2- aminobenzoate). Synthetic flavoring substances and Piperonal (3,4-methylenedioxy-benzaldehyde, adjuvants that are generally recog- heliotropin). nized as safe for their intended use, Vanillin. within the meaning of section 409 of the act, are as follows: § 582.80 Trace minerals added to animal feeds. Acetaldehyde (ethanal). Acetoin (acetyl methylcarbinol). These substances added to animal Aconitic acid (equisetic acid, citridic acid, feeds as nutritional dietary supple- achilleic acid). ments are generally recognized as safe Anethole (parapropenyl anisole). when added at levels consistent with Benzaldehyde (benzoic aldehyde). good feeding practice. 1 N-Butyric acid (butanoic acid). d- or l-Carvone (carvol). Element Source compounds Cinnamaldehyde (cinnamic aldehyde). Citral (2,6-dimethyloctadien-2,6-al-8, Cobalt ...... Cobalt acetate. geranial, neral). Cobalt carbonate. Cobalt chloride. Decanal (N-decylaldhehyde, capraldehyde, Cobalt oxide. capric aldehyde, caprinaldehyde, aldehyde Cobalt sulfate. C-10). Copper ...... Copper carbonate. Diacetyl (2,3-butandeione). Ethyl acetate. Copper chloride. Ethyl butyrate. Copper gluconate. 3-Methyl-3-phenyl glycidic acid ethyl ester Copper hydroxide. (ethyl-methyl-phenyl-glycidate, so-called Copper orthophosphate. Copper oxide. strawberry aldehyde, C-16 aldehyde). Copper pyrophosphate. Ethyl vanillin. Copper sulfate. Eugenol. Iodine ...... Calcium iodate. Geranoil (3,7-dimethyl-2,6 and 3,6-octadien-1- Calcium iodobehenate. ol). Cuprous iodide. Geranyl acetate (geraniol acetate). 3,5-Diiodosalicylic acid. Glycerol (glyceryl) tributyrate (tributyrin, Ethylenediamine dihydroiodide. butyrin). Potassium iodate. Limonene (d-, l-, and dl-). Potassium iodide. Linalool (linalol, 3,7-dimethyl-1,6-octadien-3- ol). 1 All substances listed may be in anhydrous Linalyl acetate (bergamol). or hydrated form.

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Element Source compounds used in accordance with good manufacturing or feeding practice. Sodium iodate. Sodium iodide. Thymol iodide. § 582.1057 Hydrochloric acid. Iron ...... Iron ammonium citrate. (a) Product. Hydrochloric acid. Iron carbonate. Iron chloride. (b) [Reserved] Iron gluconate. (c) Limitations, restrictions, or expla- Iron oxide. nation. This substance is generally rec- Iron phosphate. Iron pyrophosphate. ognized as safe when used as a buffer Iron sulfate. and neutralizing agent in accordance Reduced iron. with good manufacturing or feeding Manganese ...... Manganese acetate. practice. Manganese carbonate. Manganese citrate (soluble). Manganese chloride. § 582.1061 Lactic acid. Manganese gluconate. Manganese orthophosphate. (a) Product. Lactic acid. Manganese phosphate (dibasic). (b) Conditions of use. This substance Manganese sulfate. is generally recognized as safe when Manganous oxide. used in accordance with good manufac- Zinc ...... Zinc acetate. Zinc carbonate. turing or feeding practice. Zinc chloride. Zinc oxide. § 582.1069 Malic acid. Zinc sulfate. (a) Product. Malic acid. (b) Conditions of use. This substance § 582.99 Adjuvants for pesticide chemi- is generally recognized as safe when cals. used in accordance with good manufac- Adjuvants, identified and used in ac- turing or feeding practice. cordance with 40 CFR 180.1001(c) and (d), which are added to pesticide use di- § 582.1073 Phosphoric acid. lutions by a grower or applicator prior (a) Product. Phosphoric acid. to application to the raw agricultural (b) Conditions of use. This substance commodity, are exempt from the re- is generally recognized as safe when quirement of tolerances under section used in accordance with good manufac- 409 of the act. turing or feeding practice. Subpart B—General Purpose Food § 582.1077 Potassium acid tartrate. Additives (a) Product. Potassium acid tartrate. (b) Conditions of use. This substance § 582.1005 Acetic acid. is generally recognized as safe when (a) Product. Acetic acid. 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- § 582.1087 Sodium acid pyrophosphate. turing or feeding practice. (a) Product. Sodium acid pyrophosphate. § 582.1009 Adipic acid. (b) Conditions of use. This substance (a) Product. Adipic acid. is generally recognized as safe when (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 buffer § 582.1091 Succinic acid. and neutralizing agent in accordance (a) Product. Succinic acid. with good manufacturing or feeding (b) Conditions of use. This substance practice. is generally recognized as safe when used in accordance with good manufac- § 582.1033 Citric acid. turing or feeding practice. (a) Product. Citric acid. (b) Conditions of use. This substance § 582.1095 Sulfuric acid. is generally recognized as safe when (a) Product. Sulfuric acid.

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(b) Conditions of use. This substance § 582.1139 Ammonium hydroxide. is generally recognized as safe when (a) Product. Ammonium hydroxide. used in accordance with good manufacturing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.1099 Tartaric acid. used in accordance with good manufacturing or feeding practice. (a) Product. Tartaric acid. (b) Conditions of use. This substance § 582.1141 Ammonium phosphate. is generally recognized as safe when used in accordance with good manufac- (a) Product. Ammonium phosphate turing or feeding practice. (mono- and dibasic). (b) Conditions of use. This substance § 582.1125 Aluminum sulfate. is generally recognized as safe when (a) Product. Aluminum sulfate. used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when § 582.1143 Ammonium sulfate. used in accordance with good manufacturing or feeding practice. (a) Product. Ammonium sulfate. (b) Conditions of use. This substance § 582.1127 Aluminum ammonium sul- is generally recognized as safe when fate. used in accordance with good manufac- (a) Product. Aluminum ammonium turing or feeding practice. sulfate. (b) Conditions of use. This substance § 582.1155 Bentonite. is generally recognized as safe when (a) Product. Bentonite. 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- § 582.1129 Aluminum potassium sul- turing or feeding practice. fate. (a) Product. Aluminum potassium sul- § 582.1165 Butane. fate. (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. § 582.1131 Aluminum sodium sulfate. § 582.1191 Calcium carbonate. (a) Product. Aluminum sodium sulfate. (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.

§ 582.1135 Ammonium bicarbonate. § 582.1193 Calcium chloride. (a) Product. Ammonium bicarbonate. (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.

§ 582.1137 Ammonium carbonate. § 582.1195 Calcium citrate. (a) Product. Ammonium carbonate. (a) Product. Calcium citrate. (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.

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§ 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. (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 as a bleach- ing agent in accordance with good § 582.1217 Calcium phosphate. manufacturing or feeding practice. (a) Product. Calcium phosphate (mono-, di-, and tribasic). § 582.1400 Lecithin. (b) Conditions of use. This substance (a) Product. Lecithin. 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. § 582.1235 Caramel. (a) Product. Caramel. § 582.1425 Magnesium carbonate. (b) Conditions of use. This substance (a) Product. Magnesium carbonate. 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. § 582.1240 Carbon dioxide. (a) Product. Carbon dioxide. § 582.1428 Magnesium hydroxide. (b) Conditions of use. This substance (a) Product. Magnesium hydroxide. 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. § 582.1275 Dextrans. (a) Product. Dextrans of average mo- § 582.1431 Magnesium oxide. lecular weight below 100,000. (a) Product. Magnesium 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.

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§ 582.1480 Methylcellulose. (b) Conditions of use. This substance 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 more than 31.5 percent on a dry-weight § 582.1631 Potassium hydroxide. 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. used in accordance with good manufacturing or feeding practice. § 582.1666 Propylene glycol. (a) Product. Propylene glycol. § 582.1540 Nitrogen. (b) Conditions of use. This substance (a) Product. Nitrogen. is generally recognized as safe (except (b) Conditions of use. This substance in cat food) when used in accordance is generally recognized as safe when with good manufacturing or feeding used in accordance with good manufac- practice. turing or feeding practice. [41 FR 38657, Sept. 10, 1976, as amended at 61 § 582.1585 Papain. FR 19544, May 2, 1996] (a) Product. Papain. § 582.1685 Rennet. (b) Conditions of use. This substance (a) Product. Rennet (rennin). 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. § 582.1613 Potassium bicarbonate. (a) Product. Potassium bicarbonate. § 582.1711 Silica aerogel. (b) Conditions of use. This substance (a) Product. Silica aerogel as a finely is generally recognized as safe when powdered microcellular silica foam used in accordance with good manufac- having a minimum silica content of turing or feeding practice. 89.5 percent. (b) [Reserved] § 582.1619 Potassium carbonate. (c) Limitations, restrictions, or expla- (a) Product. Potassium carbonate. nation. This substance is generally rec- (b) Conditions of use. This substance ognized as safe when used as a compo- is generally recognized as safe when nent of antifoaming agents in accord- used in accordance with good manufac- ance with good manufacturing or feed- turing or feeding practice. ing practice.

§ 582.1625 Potassium citrate. § 582.1721 Sodium acetate. (a) Product. Potassium citrate. (a) Product. Sodium acetate.

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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.

§ 582.1736 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 carboxymethyl groups per used in accordance with good manufac- anhydroglucose unit, and with a min- turing or feeding practice. imum viscosity of 25 centipoises for 2 percent by weight aqueous solution at § 582.1804 Sodium potassium tartrate. 25 °C. (a) Product. Sodium potassium tar- (b) Conditions of use. This substance trate. 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. § 582.1748 Sodium caseinate. (a) Product. Sodium caseinate. § 582.1810 Sodium tripolyphosphate. (b) Conditions of use. This substance (a) Product. Sodium is generally recognized as safe when tripolyphosphate. 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- § 582.1751 Sodium citrate. turing or feeding practice. (a) Product. Sodium citrate. (b) Conditions of use. This substance § 582.1901 Triacetin. is generally recognized as safe when (a) Product. Triacetin (glyceryl used in accordance with good manufac- triacetate). turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.1763 Sodium hydroxide. used in accordance with good manufac- (a) Product. Sodium hydroxide. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.1973 Beeswax. used in accordance with good manufac- (a) Product. Beeswax (yellow wax). turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.1775 Sodium pectinate. used in accordance with good manufac- (a) Product. Sodium pectinate. turing or feeding practice.

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§ 582.1975 Bleached beeswax. § 582.2729 Hydrated sodium calcium aluminosilicate. (a) Product. Bleached beeswax (white wax). (a) Product. Hydrated sodium calcium (b) Conditions of use. This substance aluminosilicate (sodium calcium is generally recognized as safe when silicoaluminate). used in accordance with good manufac- (b) Tolerance. This substance is generally recognized as safe for use at a turing or feeding practice. level not exceeding 2 percent in accord- § 582.1978 Carnauba wax. ance with good manufacturing or feeding practice. (a) Product. Carnauba wax. (b) Conditions of use. This substance § 582.2906 Tricalcium silicate. 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 expla- § 582.3013 Ascorbic acid. nation. This substance is generally recognized as safe when used in table salt (a) Product. Ascorbic acid. (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- § 582.2227 Calcium silicate. turing or feeding practice. (a) Product. Calcium silicate. § 582.3021 Benzoic acid. (b) Tolerance. 2 percent and 5 percent. (a) Product. Benzoic acid. (c) Limitations, restrictions, or expla- (b) Tolerance. This substance is gen- nation. This substance is generally rec- erally recognized as safe for use at a ognized as safe when used at levels not level not exceeding 0.1 percent in ac- exceeding 2 percent in table salt and 5 cordance with good manufacturing or percent in baking powder in accordance feeding practice. with good manufacturing or feeding practice. § 582.3041 Erythorbic acid. (a) Product. Erythorbic acid. § 582.2437 Magnesium silicate. (b) Conditions of use. This substance (a) Product. Magnesium silicate. is generally recognized as safe when (b) Tolerance. 2 percent. used in accordance with good manufacturing or feeding practice. (c) Limitations, restrictions, or explanation. This substance is generally rec- § 582.3081 Propionic acid. ognized as safe when used in table salt (a) Product. Propionic acid. in accordance with good manufacturing (b) Conditions of use. This substance or feeding practice. is generally recognized as safe when used in accordance with good manufac- § 582.2727 Sodium aluminosilicate. turing or feeding practice. (a) Product. Sodium aluminosilicate (sodium silicoaluminate). § 582.3089 Sorbic acid. (b) Tolerance. This substance is gen- (a) Product. Sorbic acid. erally recognized as safe for use at a (b) Conditions of use. This substance level not exceeding 2 percent 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.

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§ 582.3109 Thiodipropionic acid. § 582.3225 Calcium sorbate. (a) Product. Thiodipropionic acid. (a) Product. Calcium sorbate. (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) § 582.3280 Dilauryl thiodipropionate. oil content of the food, provided the substance is used in accordance with (a) Product. Dilauryl good manufacturing or feeding prac- thiodipropionate. tice. (b) Tolerance. This substance is generally recognized as safe for use in food § 582.3149 Ascorbyl palmitate. when the total content of antioxidants is not over 0.02 percent of fat or oil (a) Product. Ascorbyl palmitate. content, including essential (volatile) (b) Conditions of use. This substance oil content of the food, provided the is generally recognized as safe when substance is used in accordance with used in accordance with good manufac- good manufacturing or feeding prac- turing or feeding practice. tice.

§ 582.3169 Butylated hydroxyanisole. § 582.3336 Gum guaiac. (a) Product. Butylated hydroxy- (a) Product. Gum guaiac. anisole. (b) Tolerance. 0.1 percent (equivalent (b) Tolerance. This substance is gen- antioxidant activity 0.01 percent). erally recognized as safe for use in food (c) Limitations, restrictions, or expla- when the total content of antioxidants nation. This substance is generally rec- is not over 0.02 percent of fat or oil ognized as safe when used in edible fats content, including essential (volatile) or oils in accordance with good manu- oil content of food provided the sub- facturing or feeding practice. stance is used in accordance with good manufacturing or feeding practice. § 582.3490 Methylparaben. (a) Product. Methylparaben (methyl § 582.3173 Butylated hydroxytoluene. p-hydroxybenzoate). (a) Product. Butylated hydroxytol- (b) Tolerance. This substance is gen- uene. erally recognized as safe for use at a (b) Tolerance. This substance is gen- level not exceeding 0.1 percent in ac- erally recognized as safe for use in food cordance with good manufacturing or when the total content of antioxidants feeding practice. is not over 0.02 percent of fat or oil § 582.3616 Potassium bisulfite. content, including essential (volatile) oil content of food provided the sub- (a) Product. Potassium bisulfite. stance is used in accordance with good (b) [Reserved] manufacturing or feeding practice. (c) Limitations, restrictions, or explanation. This substance is generally rec- § 582.3189 Calcium ascorbate. ognized as safe when used in accordance with good manufacturing or feed- (a) Product. Calcium ascorbate. ing practice, except that it is not used (b) Conditions of use. This substance in meats or in food recognized as is generally recognized as safe when source of vitamin B used in accordance with good manufac- 1. turing or feeding practice. § 582.3637 Potassium metabisulfite. (a) Product. Potassium metabisulfite. § 582.3221 Calcium propionate. (b) [Reserved] (a) Product. Calcium propionate. (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 accord- used in accordance with good manufac- ance with good manufacturing or feed- turing or feeding practice. ing practice, except that it is not used

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in meats or in food recognized as (b) [Reserved] source of vitamin B1. (c) Limitations, restrictions, or explanation. This substance is generally rec- § 582.3640 Potassium sorbate. ognized as safe when used in accord- (a) Product. Potassium sorbate. ance with good manufacturing or feed- (b) Conditions of use. This substance ing practice, except that it is not used is generally recognized as safe when in meats or in food recognized as used in accordance with good manufac- source of vitamin B1. turing or feeding practice. § 582.3784 Sodium propionate. § 582.3660 Propyl gallate. (a) Product. Sodium propionate. (a) Product. Propyl gallate. (b) Conditions of use. This substance (b) Tolerance. This substance is gen- is generally recognized as safe when erally recognized as safe for use in food used in accordance with good manufac- when the total content of antioxidants turing or feeding practice. is not over 0.02 percent of fat or oil content, including essential (volatile) § 582.3795 Sodium sorbate. oil content of the food, provided the (a) Product. Sodium sorbate. substance is used in accordance with (b) Conditions of use. This substance good manufacturing or feeding prac- is generally recognized as safe when tice. used in accordance with good manufacturing or feeding practice. § 582.3670 Propylparaben. (a) Product. Propylparaben (propyl p- § 582.3798 Sodium sulfite. hydroxybenzoate). (a) Product. Sodium sulfite. (b) Tolerance. This substance is gen- (b) [Reserved] erally recognized as safe for use at a (c) Limitations, restrictions, or expla- level not exceeding 0.1 percent in ac- nation. This substance is generally rec- cordance with good manufacturing or ognized as safe when used in accord- feeding practice. ance with good manufacturing or feeding practice, except that it is not used § 582.3731 Sodium ascorbate. in meats or in food recognized as (a) Product. Sodium ascorbate. source of vitamin B1. (b) Conditions of use. This substance is generally recognized as safe when § 582.3845 Stannous chloride. used in accordance with good manufac- (a) Product. Stannous chloride. turing or feeding practice. (b) Tolerance. This substance is generally recognized as safe for use at a § 582.3733 Sodium benzoate. level not exceeding 0.0015 percent cal- (a) Product. Sodium benzoate. culated as tin in accordance with good (b) Tolerance. This substance is gen- manufacturing or feeding practice. erally recognized as safe for use at a level not exceeding 0.1 percent in ac- § 582.3862 Sulfur dioxide. cordance with good manufacturing or (a) Product. Sulfur dioxide. feeding practice. (b) [Reserved] (c) Limitations, restrictions, or expla- § 582.3739 Sodium bisulfite. nation. This substance is generally rec- (a) Product. Sodium bisulfite. 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 § 582.3890 Tocopherols. in meats or in food recognized as (a) Product. Tocopherols. source of vitamin B1. (b) Conditions of use. This substance is generally recognized as safe when § 582.3766 Sodium metabisulfite. used in accordance with good manufac- (a) Product. Sodium metabisulfite. turing or feeding practice.

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Subpart E—Emulsifying Agents § 582.5017 Aspartic acid. (a) Product. Aspartic acid (L- and DL- § 582.4101 Diacetyl tartaric acid esters of mono- and diglycerides of edible forms). fats or oils, or edible fat-forming (b) Conditions of use. This substance fatty acids. is generally recognized as safe when (a) Product. Diacetyl tartaric acid used in accordance with good manufac- esters of mono- and diglycerides of edi- turing or feeding practice. ble fats or oils, or edible fat-forming fatty acids. § 582.5049 Aminoacetic acid. (b) Conditions of use. This substance (a) Product. Glycine (aminoacetic is generally recognized as safe when acid). used in accordance with good manufac- (b) [Reserved] turing or feeding practice. (c) Limitations, restrictions, or explanation. This substance is generally rec- § 582.4505 Mono- and diglycerides of ognized as safe when used in animal edible fats or oils, or edible fat- feeds in accordance with good manu- forming acids. facturing or feeding practice. (a) Product. Mono- and diglycerides of edible fats or oils, or edible fat-forming § 582.5065 Linoleic acid. acids. (b) Conditions of use. This substance (a) Product. Linoleic acid prepared is generally recognized as safe when from edible fats and oils and free from used in accordance with good manufac- chick-edema factor. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.4521 Monosodium phosphate de- used in accordance with good manufac- rivatives of mono- and diglycerides turing or feeding practice. of edible fats or oils, or edible fat- forming fatty acids. § 582.5118 Alanine. (a) Product. Monosodium phosphate (a) Product. Alanine (L- and DL- derivatives of mono- and diglycerides forms). of edible fats or oils, or edible fat-form- (b) Conditions of use. This substance ing fatty acids. 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. § 582.5145 Arginine. § 582.4666 Propylene glycol. (a) Product. Arginine (L- and DL- forms). (a) Product. Propylene glycol. (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. § 582.5159 Biotin. Subpart F—Nutrients and/or Dietary Supplements 1 (a) Product. Biotin. (b) Conditions of use. This substance § 582.5013 Ascorbic acid. is generally recognized as safe when (a) Product. Ascorbic acid. used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when § 582.5191 Calcium carbonate. used in accordance with good manufacturing or feeding practice. (a) Product. Calcium carbonate. (b) Conditions of use. This substance 1 Amino acids listed in this subpart may be is generally recognized as safe when free hydrochloride salt, hydrated, or anhy- used in accordance with good manufac- drous form, where applicable. turing or feeding practice.

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§ 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). (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.

§ 582.5217 Calcium phosphate. § 582.5273 Cystine. (a) Product. Calcium phosphate (a) Product. Cystine (L- and DL- (mono-, di-, and tribasic). 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.

§ 582.5223 Calcium pyrophosphate. § 582.5301 Ferric phosphate. (a) Product. Calcium pyrophosphate. (a) Product. Ferric 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.

§ 582.5230 Calcium sulfate. § 582.5304 Ferric pyrophosphate. (a) Product. Calcium sulfate. (a) Product. Ferric pyrophosphate. (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.

§ 582.5245 Carotene. § 582.5306 Ferric sodium (a) Product. Carotene. pyrophosphate. (b) Conditions of use. This substance (a) Product. Ferric sodium is generally recognized as safe when pyrophosphate. 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- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when used in accordance with good manufac- § 582.5308 Ferrous gluconate. turing or feeding practice. (a) Product. Ferrous gluconate. (b) Conditions of use. This substance § 582.5411 Lysine. is generally recognized as safe when (a) Product. Lysine (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 § 582.5311 Ferrous lactate. used in accordance with good manufac- (a) Product. Ferrous lactate. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.5431 Magnesium oxide. used in accordance with good manufac- (a) Product. Magnesium oxide. turing or feeding practice. (b) Conditions of use. This substance § 582.5315 Ferrous sulfate. is generally recognized as safe when used in accordance with good manufac- (a) Product. Ferrous sulfate. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.5434 Magnesium phosphate. used in accordance with good manufacturing or feeding practice. (a) Product. Magnesium phosphate (di- and tribasic). § 582.5361 Histidine. (b) Conditions of use. This substance (a) Product. Histidine (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- § 582.5443 Magnesium sulfate. turing or feeding practice. (a) Product. Magnesium sulfate. (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- § 582.5446 Manganese chloride. turing or feeding practice. (a) Product. Manganese chloride. (b) Conditions of use. This substance § 582.5375 Iron reduced. 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- § 582.5449 Manganese citrate. turing or feeding practice. (a) Product. Manganese citrate. § 582.5381 Isoleucine. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Isoleucine (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 § 582.5452 Manganese gluconate. used in accordance with good manufacturing or feeding practice. (a) Product. Manganese gluconate. (b) Conditions of use. This substance § 582.5406 Leucine. is generally recognized as safe when (a) Product. Leucine (L- and DL- used in accordance with good manufac- forms). turing or feeding practice.

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§ 582.5455 Manganese § 582.5530 Niacin. 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 manufacturing or feeding practice. § 582.5535 Niacinamide. (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 § 582.5590 Phenylalanine. used in accordance with good manufacturing or feeding practice. (a) Product. Phenylalanine (L- and DL-forms). § 582.5464 Manganous oxide. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Manganous oxide. 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- § 582.5622 Potassium chloride. turing or feeding practice. (a) Product. Potassium chloride. § 582.5470 Mannitol. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Mannitol. 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- § 582.5628 Potassium turing or feeding practice. glycerophosphate. (a) Product. Potassium § 582.5475 Methionine. glycerophosphate. (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 feeds in accordance with good manu- § 582.5634 Potassium iodide. facturing or feeding practice. (a) Product. Potassium iodide. (b) Tolerance. 0.01 percent. § 582.5477 Methionine hydroxy analog (c) Limitations, restrictions, or expla- and its calcium salts. nation. This substance is generally rec- (a) Product. Methionine hydroxy ana- ognized as safe when used in table salt log and its calcium salts. as a source of dietary iodine in accord- (b) [Reserved] ance with good manufacturing or feed- (c) Limitations, restrictions, or expla- ing practice. nation. This substance is generally recognized as safe when used in animal § 582.5650 Proline. feeds in accordance with good manu- (a) Product. Proline (L- and DL- facturing or feeding practice. forms).

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§ 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) -Tocopherol acetate. (b) Conditions of use. This substance Product. a 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. § 582.5772 Sodium pantothenate. § 582.5915 Tryptophane. (a) Product. Sodium pantothenate. (b) Conditions of use. This substance (a) Product. Tryptophane (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- § 582.5778 Sodium phosphate. turing or feeding practice. (a) Product. Sodium phosphate § 582.5920 Tyrosine. (mono-, di-, and tribasic). (b) Conditions of use. This substance (a) Product. Tyrosine (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- § 582.5835 Sorbitol. turing or feeding practice. (a) Product. Sorbitol. (b) Conditions of use. This substance § 582.5925 Valine. is generally recognized as safe when (a) Product. Valine (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 § 582.5875 Thiamine hydrochloride. used in accordance with good manufac- (a) Product. Thiamine hydrochloride. turing or feeding practice.

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§ 582.5930 Vitamin A. (b) Conditions of use. This substance (a) Product. Vitamin A. 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- § 582.5994 Zinc stearate. turing or feeding practice. (a) Product. Zinc stearate prepared § 582.5933 Vitamin A acetate. from stearic acid free from chick- (a) Product. Vitamin A acetate. edema factor. (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.

§ 582.5936 Vitamin A palmitate. § 582.5997 Zinc sulfate. (a) Product. Vitamin A palmitate. (a) Product. Zinc sulfate. (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.

2 § 582.5945 Vitamin B 12. Subpart G—Sequestrants

(a) Product. Vitamin B12. (b) Conditions of use. This substance § 582.6033 Citric acid. is generally recognized as safe when (a) Product. Citric acid. 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- § 582.5950 Vitamin D 2. turing or feeding practice.

(a) Product. Vitamin D2. (b) Conditions of use. This substance § 582.6085 Sodium acid phosphate. is generally recognized as safe when (a) Product. Sodium acid phosphate. 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- § 582.5953 Vitamin D 3. turing or feeding practice.

(a) Product. Vitamin D3. (b) Conditions of use. This substance § 582.6099 Tartaric acid. is generally recognized as safe when (a) Product. Tartaric acid. 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- § 582.5985 Zinc chloride. turing or feeding practice. (a) Product. Zinc chloride. (b) Conditions of use. This substance § 582.6185 Calcium acetate. is generally recognized as safe when (a) Product. Calcium acetate. 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- § 582.5988 Zinc gluconate. turing or feeding practice. (a) Product. Zinc gluconate. (b) Conditions of use. This substance § 582.6193 Calcium chloride. is generally recognized as safe when (a) Product. Calcium chloride. used in accordance with good manufacturing or feeding practice. 2 For the purpose of this subpart, no attempt has been made to designate those § 582.5991 Zinc oxide. sequestrants that may also function as (a) Product. Zinc oxide. chemical preservatives.

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(b) Conditions of use. This substance § 582.6290 Disodium phosphate. is generally recognized as safe when (a) Product. Disodium phosphate. 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- § 582.6195 Calcium citrate. turing or feeding practice. (a) Product. Calcium citrate. (b) Conditions of use. This substance § 582.6386 Isopropyl citrate. is generally recognized as safe when (a) Product. Isopropyl citrate. used in accordance with good manufac- (b) Tolerance. This substance is gen- turing or feeding practice. erally recognized as safe for use at a level not exceeding 0.02 percent in ac- § 582.6197 Calcium diacetate. cordance with good manufacturing or (a) Product. Calcium diacetate. feeding practice. (b) Conditions of use. This substance § 582.6511 Monoisopropyl citrate. is generally recognized as safe when used in accordance with good manufac- (a) Product. Monoisopropyl citrate. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.6199 Calcium gluconate. used in accordance with good manufacturing or feeding practice. (a) Product. Calcium gluconate. (b) Conditions of use. This substance § 582.6625 Potassium citrate. is generally recognized as safe when (a) Product. Potassium 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- § 582.6203 Calcium hexametaphosphate. turing or feeding practice. (a) Product. Calcium [41 FR 38657, Sept. 10, 1976. Redesignated at hexametaphosphate. 42 FR 14091, Mar. 15, 1977] (b) Conditions of use. This substance § 582.6751 Sodium citrate. is generally recognized as safe when used in accordance with good manufac- (a) Product. Sodium citrate. (b) This substance turing or feeding practice. Conditions of use. is generally recognized as safe when § 582.6215 Monobasic calcium phos- used in accordance with good manufac- phate. turing or feeding practice. (a) Product. Monobasic calcium phos- [41 FR 38657, Sept. 10, 1976. Redesignated at phate. 42 FR 14091, Mar. 15, 1977] (b) Conditions of use. This substance § 582.6754 Sodium diacetate. is generally recognized as safe when used in accordance with good manufac- (a) Product. Sodium diacetate. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.6219 Calcium phytate. used in accordance with good manufacturing or feeding practice. (a) Product. Calcium phytate. (b) Conditions of use. This substance § 582.6757 Sodium gluconate. is generally recognized as safe when (a) Product. Sodium gluconate. 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- § 582.6285 Dipotassium phosphate. turing or feeding practice. (a) Product. Dipotassium phosphate. (b) Conditions of use. This substance § 582.6760 Sodium is generally recognized as safe when hexametaphosphate. used in accordance with good manufac- (a) Product. Sodium turing or feeding practice. hexametaphosphate.

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(b) Conditions of use. This substance § 582.6810 Sodium tripolyphosphate. is generally recognized as safe when (a) Product. Sodium used in accordance with good manufac- tripolyphosphate. turing or feeding practice. (b) Conditions of use. This substance § 582.6769 Sodium metaphosphate. is generally recognized as safe when used in accordance with good manufac- (a) Product. Sodium metaphosphate. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.6851 Stearyl citrate. used in accordance with good manufac- (a) Product. Stearyl citrate. turing or feeding practice. (b) Tolerance. This substance is gen- § 582.6778 Sodium phosphate. erally recognized as safe for use at a level not exceeding 0.15 percent in ac- (a) Product. Sodium phosphate cordance with good manufacturing or (mono-, di-, and tribasic). feeding practice. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufac- Subpart H—Stabilizers turing or feeding practice. § 582.7115 Agar-agar. § 582.6787 Sodium pyrophosphate. (a) Product. Agar-agar. (a) Product. Sodium pyrophosphate. (b) Conditions of use. This substance (b) Condition of use. This substance is is generally recognized as safe when generally recognized as safe when used used in accordance with good manufac- in accordance with good manufacturing turing or feeding practice. or feeding practice. § 582.7133 Ammonium alginate. § 582.6789 Tetra sodium (a) Product. Ammonium alginate. pyrophosphate. (b) Conditions of use. This substance (a) Product. Tetra sodium is generally recognized as safe when pyrophosphate. 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- § 582.7187 Calcium alginate. turing or feeding practice. (a) Product. Calcium alginate. (b) Conditions of use. This substance § 582.6801 Sodium tartrate. is generally recognized as safe when (a) Product. Sodium tartrate. 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- § 582.7255 Chondrus extract. turing or feeding practice. (a) Product. Chondrus extract (carrageenin). § 582.6804 Sodium potassium tartrate. (b) Conditions of use. This substance (a) Product. Sodium potassium tar- is generally recognized as safe when trate. 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- § 582.7330 Gum arabic. turing or feeding practice. (a) Product. Acacia (gum arabic). (b) Conditions of use. This substance § 582.6807 Sodium thiosulfate. is generally recognized as safe when (a) Product. Sodium thiosulfate. used in accordance with good manufac- (b) Tolerance. 0.1 percent. turing or feeding practice. (c) Limitations, restrictions, or explanation. This substance is generally rec- § 582.7333 Gum ghatti. ognized as safe when used in salt in ac- (a) Product. Gum ghatti. cordance with good manufacturing or (b) Conditions of use. This substance feeding practice. is generally recognized as safe when

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used in accordance with good manufac- Subpart B—Listing of Specific Substances turing or feeding practice. Affirmed as GRAS

§ 582.7339 Guar gum. Sec. 584.200 Ethyl alcohol containing ethyl ace- (a) Product. Guar gum. tate. (b) Conditions of use. This substance 584.700 Hydrophobic silicas.

is generally recognized as safe when 584.725 25–Hydroxyvitamin D3. used in accordance with good manufac- AUTHORITY: 21 U.S.C. 321, 342, 348, 371. turing or feeding practice.

§ 582.7343 Locust bean gum. Subpart A [Reserved] (a) Product. Locust (carob) bean gum. (b) Conditions of use. This substance Subpart B—Listing of Specific is generally recognized as safe when Substances Affirmed as GRAS used in accordance with good manufac- § 584.200 Ethyl alcohol containing turing or feeding practice. ethyl acetate. § 582.7349 Sterculia gum. The feed additive ethyl alcohol containing ethyl acetate meets the re- (a) Product. Sterculia gum (karaya quirement of 27 CFR 21.62, being not gum). less than 92.5 percent ethyl alcohol, (b) Conditions of use. This substance each 100 gallons having had added the is generally recognized as safe when equivalent of 4.25 gallons of 100 percent used in accordance with good manufac- ethyl acetate. It is used in accordance turing or feeding practice. with good feeding practices in ruminant feed supplements as a source of § 582.7351 Gum tragacanth. added energy. (a) Product. Tragacanth (gum [46 FR 52333, Oct. 27, 1981, as amended at 72 tragacanth). FR 41620, July 31, 2007] (b) Conditions of use. This substance is generally recognized as safe when § 584.700 Hydrophobic silicas. used in accordance with good manufac- (a) Product. Amorphous fumed hydro- turing or feeding practice. phobic silica or precipitated hydro- § 582.7610 Potassium alginate. phobic silica (CAS Reg. No. 68611–0944– 099, silane, dichlorodimethyl-, reaction (a) Product. Potassium alginate. products with silica). (b) Conditions of use. This substance (b) Conditions of use. An anticaking/ is generally recognized as safe when free-flow agent in vitamin preparations used in accordance with good manufac- for animal feed. turing or feeding practice. (c) Limitations. Not to exceed 5 percent in the vitamin preparation. It § 582.7724 Sodium alginate. shall be used in accordance with good (a) Product. Sodium alginate. manufacturing or feeding practices. It (b) Conditions of use. This substance must be of purity suitable for intended is generally recognized as safe when use, and it must comply with the fol- used in accordance with good manufac- lowing specifications: turing or feeding practice. (i) Amorphous fumed hydrophobic silica: Not less than 99.0 percent silicon dioxide after ignition. Not more than 3 PART 584—FOOD SUBSTANCES AF- ppm arsenic. Not more than 0.003 per- FIRMED AS GENERALLY RECOG- cent heavy metals (as lead). Not more NIZED AS SAFE IN FEED AND than 10 ppm lead. Not more than 2.5 DRINKING WATER OF ANIMALS percent loss on drying. Not more than 2 percent loss on ignition after drying. Subpart A [Reserved] Not more than 1 percent insoluble substances. Not more than 50 parts per million dichlorodimethylsilane.

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(ii) Precipated hydrophobic silica: be used simultaneously in both feed Not less than 94.0 percent silicon diox- and water. ide after ignition. Not more than 3 ppm 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 per- ITED FROM USE IN ANIMAL FOOD cent loss on ignition after drying. Not OR FEED more than 5 percent soluble ionizable salts (as sodium sulfate). Not more Subpart A—General Provisions than 1 percent insoluble substances. 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 D3. 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. 589.1001 Propylene glycol in or on cat food. (b) Conditions of use. This substance 589.2000 Animal proteins prohibited in rumi- is generally recognized as safe as a nant 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. (c) Limitations. (1) Not to exceed 69 AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 371. parts per billion (ppb) in feed or 34.5 ppb in drinking water. It shall be used in accordance with good manufacturing Subpart A—General Provisions and feeding practices. § 589.1 Substances prohibited from use (2) The product must comply with in animal food or feed. the following specifications: (i) Not less than 94.0 percent 25- (a) The substances listed in this part have been prohibited from use in ani- hydroxyvitamin D3. (ii) Not more than 1 percent of any mal food or feed by the Food and Drug individual sterol. Administration because of a deter- (iii) Not more than 5 percent water. mination that they present a potential (iv) Not more than 20 parts per mil- risk to the public health or have not lion (ppm) lead. been shown by adequate scientific data (v) Not more than 20 ppm aluminum. to be safe for use in such food or feed. (vi) Not more than 1.0 percent sol- Use of any of these substances in viola- vents and non-detectable levels of 2’, 4’, tion of this part causes the animal food 5’, 7’-tetraiodofluorescin. or feed involved to be adulterated and (3) Product labeling shall bear the in violation of the Act. following: (b) This part includes only a partial (i) A statement to indicate that the list of substances prohibited from use maximum use level of 25- in animal food or feed; it is for easy hydroxyvitamin D3 must not exceed 69 reference purposes and is not a com- ppb in feed or 34.5 ppb in drinking plete list of substances that may not water. lawfully be used in such animal food or (ii) Adequate use directions to ensure feed. No substance may be used in ani- that 25-hydroxyvitamin D3 (and all pre- mal food or feed unless it meets all ap- mixes) is uniformly blended through- plicable requirements of the Act. out the feed or drinking water. (c) The Food and Drug Administra- (iii) An expiration date on all premix tion either on its own initiative or on labeling. behalf of any interested person who has (iv) A statement on all premix label- submitted a petition, may publish a ing (feed and drinking water forms) proposal to establish, amend, or repeal that 25-hydroxyvitamin D3 should not a regulation under this part on the 539

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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- [61 FR 19544, May 2, 1996] ISTER for comment if it contains reasonable 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 impurities and tallow derivatives as speci- The Food and Drug Administration fied in § 589.2001; inspected meat prod- has determined that gentian violet has ucts which have been cooked and of- not been shown by adequate scientific fered for human food and further heat data to be safe for use in animal feed. processed for feed (such as plate waste Use of gentian violet in animal feed and used cellulosic food casings); milk causes the feed to be adulterated and in products (milk and milk proteins); and violation of the Federal Food, Drug, any product whose only mammalian and Cosmetic Act (the act), in the ab- protein consists entirely of porcine or sence of a regulation providing for its equine protein. safe use as a food additive under sec- (2) Renderer means any firm or indi- tion 409 of the act, unless it is subject vidual that processes slaughter byprod- to an effective notice of claimed inves- ucts, animals unfit for human con- tigational exemption for a food addi- sumption, or meat scraps. The term in- tive under § 570.17 of this chapter, or cludes persons who collect such mate- unless the substance is intended for use rials and subject them to minimal as a new animal drug and is subject to processing, or distribute them to firms an approved application under section other than renderers (as defined here) 512 of the act, or an index listing under whose intended use for the products section 572 of the act, or an effective may include animal feed. The term in- notice of claimed investigational ex- cludes renderers that also blend animal emption for a new animal drug under protein products. part 511 of this chapter or § 516.125 of (3) Blender means any firm or indi- this chapter. vidual which obtains processed animal [72 FR 69131, Dec. 6, 2007] protein from more than one source or from more than one species, and subse- § 589.1001 Propylene glycol in or on quently mixes (blends) or redistributes cat food. an animal protein product. The Food and Drug Administration (4) Feed manufacturer includes manu- has determined that propylene glycol facturers of complete and intermediate in or on cat food has not been shown by feeds intended for animals, and inadequate scientific data to be safe for cludes on-farm in addition to off-farm use. Use of propylene glycol in or on feed manufacturing and mixing oper- cat food causes the feed to be adulter- ations. ated and in violation of the Federal (5) Nonmammalian protein includes Food, Drug, and Cosmetic Act (the proteins from nonmammalian animals. act), in the absence of a regulation pro- (6) Distributor includes persons who viding for its safe use as a food additive distribute or transport feeds or feed in- under section 409 of the act, unless it is gredients intended for animals. subject to an effective notice of (7) Ruminant includes any member of claimed investigational exemption for the order of animals which has a stom- a food additive under § 570.17 of this ach with four chambers (rumen, reticu- chapter, or unless the substance is in- lum, omasum, and abomasum) through tended for use as a new animal drug which feed passes in digestion. The

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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 measures to ensure that materials whose design has been made available identified in paragraph (b) of this sec- to the public. tion are not used in the feed of (4) Renderers shall comply with all ruminants: applicable requirements under (i) Label the materials as follows: § 589.2001. ‘‘Do not feed to cattle or other (d) Requirements for protein blenders, ruminants’’; and feed manufacturers, and distributors that (ii) Maintain records sufficient to are not included in paragraph (e) of this track the materials throughout their section. (1) Protein blenders, feed manu- receipt, processing, and distribution, facturers, and distributors that manu- and make the copies available for in- facture, blend, process, and distribute spection and copying by the Food and products that contain or may contain Drug Administration. protein derived from mammalian tis- (2) Renderers described in paragraph sues shall comply with paragraph (c)(1) (c)(1) of this section will be exempted of this section. from the requirements of paragraphs (2) Protein blenders, feed manufac- (c)(1)(i) and (c)(1)(ii) of this section if turers, and distributors, shall be ex- they: empt from paragraphs (d)(1) of this sec- (i) Use exclusively a manufacturing tion if they: method that has been validated by the (i) Purchase animal products from Food and Drug Administration to de- renderers that certified compliance activate the agent that causes trans- with paragraph (c)(2) of this section or missible spongiform encephalopathy purchase such materials from parties (TSE) and whose design has been made that certify that the materials were available to the public; purchased from renderers that certified (ii) Use routinely a test method that compliance with paragraph (c)(2) of has been validated by the Food and this section; or Drug Administration to detect the (ii) Comply with the requirements of presence of the agent that causes paragraph (c)(2) of this section where TSE’s and whose design has been made appropriate. available to the public. Renderers (3) Protein blenders, feed manufac- whose products test positive for agents turers, and distributors, shall be ex- that cause TSE’s must comply with empt from paragraph (c)(1)(ii) of this paragraphs (c)(1)(i) and (c)(1)(ii) of this section if they:

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(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. accordance with paragraph (c) or (d) of this section, as appropriate. (3) 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 (f) Requirements for establishments and for inspection and copying by the Food individuals that are responsible for feed- and Drug Administration. ing ruminant animals. Establishments (e) Requirements for persons that intend and individuals that are responsible for to separate mammalian and nonmamma- feeding ruminant animals shall main- lian materials. (1) Renderers, protein tain copies of purchase invoices and la- blenders, feed manufacturers, distribu- beling for all feeds containing animal tors, and others that manufacture, protein products received, and make process, blend and distribute both prod- the copies available for inspection and ucts that contain or may contain pro- copying by the Food and Drug Admin- tein derived from mammalian tissues istration. or feeds containing such products, and (g) Adulteration and misbranding. (1) protein products from other animal tis- Animal protein products, and feeds sues or feeds containing such products, containing such products, that are not and that intend to keep those products in compliance with paragraphs (c) separate shall: through (f) of this section, excluding (i) Comply with paragraphs (c)(1) or labeling requirements, will be deemed (d)(1) of this section as appropriate ex- adulterated under section 402(a)(2)(C) cept that the labeling requirement or 402(a)(4) of the act. shall apply only to products that con- (2) Animal protein products, and tain or may contain protein derived feeds containing such products, that from mammalian tissues or feeds con- are not in compliance with the labeling taining such products; requirements of paragraphs (c) through (ii) In the case of a renderer, obtain (f) of this section will be deemed mis- nonmammalian or pure porcine or pure branded under section 403(a)(1) or 403(f) equine materials only from single-spe- of the act. cies slaughter facilities; (h) Inspection; records retention. (1) (iii) Provide for measures to avoid Records that are to be made available commingling or cross-contamination; for inspection and copying, as required (A) Maintain separate equipment or by this section, shall be kept for a min- facilities for the manufacture, proc- imum of 1 year.

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(2) Written procedures required by impurities must be measured by the this section shall be made available for method entitled ‘‘Insoluble Impurities’’ inspection and copying by the Food (AOCS Method Ca 3a–46), American Oil and Drug Administration. 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 part 51, or another method equivalent EFFECTIVE DATE NOTE: At 62 FR 30976, June in accuracy, precision, and sensitivity 5, 1997, § 589.2000 was added. Paragraph (e)(1)(iv) of this section contains information to AOCS Official Method Ca 3a–46. You collection and recordkeeping requirements may obtain copies of the method from and will not become effective until approval the AOCS (http://www.aocs.org), 2211 W. has been given by the Office of Management Bradley Ave., Champaign, IL 61821. and Budget. Copies may be examined at the Center for Food Safety and Applied Nutri- § 589.2001 Cattle materials prohibited tion’s Library, 5100 Paint Branch in animal food or feed to prevent the transmission of bovine Pkwy., College Park, MD 20740, or at spongiform encephalopathy. the National Archives and Records Ad- ministration (NARA). For information (a) Purpose—The purpose of this sec- on the availability of this material at tion is to prohibit the use of certain NARA, call 202–741–6030, or go to: http:// cattle origin materials in the food or www.archives.gov/federallregister/ feed of all animals to further reduce codeloflfederallregulations/ the risk of the spread of bovine ibrllocations.html. spongiform encephalopathy (BSE) (C) Materials as defined in para- within the United States. graphs (b)(1)(ii), (b)(1)(iii), (b)(1)(iv) (b) Definitions—(1) Cattle materials pro- (other than mechanically separated hibited in animal feed include: (i) The entire carcass of BSE-positive beef from the carcass of a BSE-positive cattle; cattle), and (b)(1)(v) of this section (ii) The brains and spinal cords of from cattle from a country that has cattle 30 months of age and older; been designated under paragraph (f) of (iii) The entire carcass of cattle not this section. inspected and passed for human con- (2) Cattle not inspected and passed for sumption as defined in paragraph (b)(2) human consumption means cattle that of this section that are 30 months of did not pass antemortem inspection by age or older from which brains and spi- the appropriate regulatory authority. nal cords were not effectively removed This term includes nonambulatory dis- or otherwise effectively excluded from abled cattle. Nonambulatory disabled animal feed; cattle are cattle that cannot rise from (iv) Mechanically separated beef as a recumbent position or that cannot defined in paragraph (b)(3) of this sec- walk, including, but not limited to, tion that is derived from materials those with broken appendages, severed specified in paragraphs (b)(1)(i), tendons or ligaments, nerve paralysis, (b)(1)(ii), and (b)(1)(iii) of this section; fractured vertebral column, or meta- and bolic conditions. (v) Tallow as defined in paragraph (3) Mechanically separated beef means (b)(5) of this section that is derived a finely comminuted meat food prod- from materials specified in paragraphs uct, resulting from the mechanical sep- (b)(1)(i), (b)(1)(ii), and (b)(1)(iii) of this aration and removal of most of the section. bone from attached skeletal muscle of (vi) Cattle materials prohibited in cattle carcasses and parts of carcasses. animal feed do not include: (4) Renderer means any firm or indi- (A) Tallow derivatives as defined in vidual that processes slaughter byprod- paragraph (b)(6) of this section; ucts, animals unfit for human con- (B) Tallow as defined in paragraph sumption, or meat scraps. The term in- (b)(5) of this section that is derived cludes persons who collect such mate- from materials specified in paragraphs rials and subject them to minimal (b)(1)(ii) and (b)(1)(iii) of this section processing, or distribute them to firms and that contains no more than 0.15 other than renderers (as defined in this percent insoluble impurities. Insoluble paragraph) whose intended use for the

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products may include animal feed, infor measures to avoid cross-contamina- dustrial use, or other uses. The term tion; includes renderers that also blend ani- (A) Use separate equipment while mal protein products. handling cattle materials prohibited in (5) Tallow means the rendered fat of animal feed; or cattle obtained by pressing or by ap- (B) Use separate containers that ade- plying any other extraction process to quately prevent contact with animal tissues derived directly from discrete feed, animal feed ingredients, or equip- adipose tissue masses or to other car- ment surfaces; cass parts and tissues. (iv) Label the cattle materials pro- (6) Tallow derivative means any prod- hibited in animal feed and products uct obtained through initial hydrol- that contain or may contain cattle ma- ysis, saponification, or trans- terials prohibited in animal feed in a esterification of tallow; chemical con- conspicuous manner as follows: ‘‘Do version of material obtained by hydrol- not feed to animals’’; ysis, saponification, or trans- (v) Mark the cattle materials prohib- esterification may be applied to obtain ited in animal feed and products that the desired product. contain or may contain cattle mate- (c) Requirements. (1) No animal feed or rials prohibited in animal feed with an feed ingredient shall be manufactured agent that can be readily detected on visual inspection; and from, processed with, or otherwise con- (vi) Establish and maintain records tain, cattle materials prohibited in sufficient to track cattle materials animal feed as defined in paragraph prohibited in animal feed to ensure (b)(1) of this section. such material is not introduced into (2) Renderers that receive, manufac- animal feed, and make the records ture, process, blend, or distribute cat- available for inspection and copying by tle materials prohibited in animal feed the Food and Drug Administration. as defined in paragraph (b)(1) of this (3) Renderers that receive, manufac- section, or products that contain or ture, process, blend, or distribute any may contain cattle materials prohib- cattle materials shall take the fol- ited in animal feed, shall take the following measures to ensure that mate- lowing measures to ensure that materials prohibited as defined in paragraph rials prohibited as defined in paragraph (b)(1) of this section are not used in (b)(1) of this section are not introduced animal feed: into animal feed: (i) Establish and maintain records (i) Exclude from use in animal feed sufficient to demonstrate that material the entire carcass of cattle not in- rendered for use in animal feed was not spected and passed for human con- manufactured from, processed with, or sumption as defined in paragraph (b)(2) does not otherwise contain, cattle ma- of this section if: terials prohibited in animal feed and (A) The brain and spinal cord are not make copies of all records available for effectively removed from such cattle or inspection and copying by the Food the brain and spinal cord from such and Drug Administration. With respect cattle are not otherwise effectively ex- to cattle materials obtained from es- cluded from animal feed; and tablishments which have segregated (B) Such cattle are 30 months of age cattle materials prohibited in animal or older. feed, such records must demonstrate (ii) If renderers remove brain and spi- that establishments supplying cattle nal cord from cattle not inspected and materials to the renderers have ade- passed for human consumption, or sep- quate procedures in place to effectively arate such animals based on whether or exclude cattle materials prohibited in not they are 30 months of age or older, animal feed; and these records shall be renderers must maintain adequate considered sufficient to meet this re- written procedures specifying how quirement if they include either: these processes are carried out. (A) Certification or other documenta- (iii) Once cattle materials prohibited tion from the supplier that material in animal feed have been separated supplied to the renderer does not in- from other cattle materials, provide clude cattle materials prohibited in

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animal feed; such certification or docu- (4) Failure of a renderer to comply mentation is acceptable, provided that with the requirements in paragraph (e) it includes a description of the segrega- of this section will render the animal tion procedures used, documentation feed or feed ingredients adulterated that the supplier confirms that its seg- under section 402(a)(4) of the act. regation procedures are in place prior (e) Inspection; records retention. to supplying any cattle material to the Records required to be made available renderer, and records of the renderer’s for inspection and copying by the Food periodic review of the suppliers’ certifi- and Drug Administration, as required cation or other documentation; or by this section, shall be kept for a min- (B) Documentation of another meth- imum of 1 year. od acceptable to FDA, such as third- (f) Process for designating countries. A party certification, for verifying that country seeking designation must send suppliers have effectively excluded cattle materials prohibited in animal feed. a written request to the Director, Of- (ii) Comply with all applicable re- fice of the Center Director, Center for quirements under § 589.2000 regarding Veterinary Medicine, at the address animal proteins prohibited in ruminant designated in § 5.1100 of this chapter. feed. The request shall include information (d) Adulteration and misbranding. (1) about that country’s BSE case history, Failure of a renderer to comply with risk factors, measures to prevent the the requirements in paragraphs (c)(2)(i) introduction and transmission of BSE, through (c)(2)(iii), (c)(2)(v) and and any other information relevant to (c)(2)(vi), or (c)(3)(i) of this section will determining whether the cattle mate- render the animal feed or feed ingredi- rials from the requesting country do or ents adulterated under section 402(a)(4) do not meet the definitions set forth in of the Federal Food, Drug, and Cos- paragraph (b)(1) of this section. FDA metic Act (the act). shall respond in writing to any such re- (2) Animal feed or feed ingredients quest and may impose conditions in that are not in compliance with para- granting any such request. Any grant graph (c)(1) of this section are adulter- by FDA of such a request under this ated under section 402(a)(2), 402(a)(3), or paragraph will be subject to future re- 402(a)(5) of the act. view by FDA and may be revoked if (3) Animal feed or feed ingredients FDA determines that the granted re- that are not in compliance with the la- quest is no longer appropriate. beling requirements of paragraph (c)(2)(iv) of this section are misbranded [73 FR 22756, Apr. 25, 2008] under section 403(a)(1) or 403(f) of the act. PARTS 590–599 [RESERVED]

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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

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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—500)

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) 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 Housing and Urban Development (Parts 2400—2499) XXV National Science Foundation (Parts 2500—2599) XXVI National Archives and Records Administration (Parts 2600—2699) XXVII Small Business Administration (Parts 2700—2799) XXVIII Department of Justice (Parts 2800—2899)

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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) XXXVII Peace Corps (Parts 3700—3799) LVIII Election Assistance Commission (Parts 5800—5899)

Title 3—The President

I Executive Office of the President (Parts 100—199)

Title 4—Accounts

I Government Accountability Office (Parts 1—199) II Recovery Accountability and Transparency Board (Parts 200— 299)

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) 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) XV Office of Administration, Executive Office of the President (Parts 2500—2599) 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) 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)

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XXXIII Overseas Private Investment Corporation (Parts 4300—4399) XXXIV Securities and Exchange Commission (Parts 4400—4499) XXXV Office of Personnel Management (Parts 4500—4599) 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) 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)

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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) XCVII Council of the Inspectors General on Integrity and Efficiency (Parts 9800—9899)

Title 6—Domestic Security

I Department of Homeland Security, Office of the Secretary (Parts 1—99) 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) 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)

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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)

Title 8—Aliens and Nationality

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)

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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) 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)

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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) XI Technology Administration, Department of Commerce (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)

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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)

Title 20—Employees’ Benefits

I Office of Workers’ Compensation Programs, Department of Labor (Parts 1—199) II Railroad Retirement Board (Parts 200—399) 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)

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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) 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)

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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) XX Office of Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Develop- ment (Parts 3200—3899) XXIV Board of Directors of the HOPE for Homeowners Program (Parts 4000—4099) 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—799) V Bureau of Indian Affairs, Department of the Interior, and Indian Health Service, Department of Health and Human Services (Part 900)

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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)

Title 29—Labor

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)

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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) 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 International Investment, 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)

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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 (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) 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 Vocational and Adult Education, Department of Edu- cation (Parts 400—499) V Office of Bilingual Education and Minority Languages Affairs, Department of Education (Parts 500—599) 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 National Institute for Literacy (Parts 1100—1199) XII National Council on Disability (Parts 1200—1299)

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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 Assistant Secretary for Technology Policy, Department of Com- merce (Parts 400—599)

Title 38—Pensions, Bonuses, and Veterans’ Relief

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)

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VII Environmental Protection Agency and Department of Defense; Uniform National Discharge Standards for Vessels of the Armed Forces (Parts 1700—1799)

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] 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) IV Centers for Medicare & Medicaid Services, Department of Health and Human Services (Parts 400—599)

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V Office of Inspector General-Health Care, Department of Health and Human Services (Parts 1000—1999)

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) 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) 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 Office of Human Development Services, Department of Health and Human Services (Parts 1300—1399)

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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 on Fine Arts (Parts 2100—2199) XXIII Arctic Research Commission (Part 2301) 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) IV National Telecommunications and Information Administration, Department of Commerce, and National Highway Traffic Safe- ty Administration, Department of Transportation (Parts 400— 499)

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 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)

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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] 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) 63 Department of Transportation Board of Contract Appeals (Parts 6300—6399) 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)

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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, Department of Transportation (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) 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 22, 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, L Rural Development Administration 7, XLII Rural Housing Service 7, XVIII, XXXV, L Rural Telephone Bank 7, XVI Rural Utilities Service 7, XVII, XVIII, XLII, L 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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2009 21 CFR—Continued 74 FR Page 21 CFR 74 FR Chapter I—Continued Page 520.2325a (a)(2) amended...... 36112 Chapter I 520.2455 (d) removed; (e) redesig- 510.600 (c)(1) table and (2) table nated as new (d); new (d)(2) re- amended...... 6823, 9767 vised ...... 7180 514.1 (a) amended; (b) introduc- 520.2475 Added ...... 28875 tory text revised ...... 54751 520.2598 Added ...... 21767 516.3 (b) amended ...... 43050 (a) amended ...... 30464 516.21 (c) removed ...... 43050 522.150 Revised ...... 65689 520.48 (b) amended...... 61516 522.246 (b) amended ...... 61516 520.100 (b)(3) revised...... 10484 522.313c (b) revised ...... 34236 520.309 (b)(2) amended ...... 21768 522.480 (a)(2) amended ...... 20582 520.445b (b)(2) revised ...... 62491 522.955 (d)(1)(i)(B) revised; 520.905a (e) removed; (d) redesig- (d)(1)(i)(C) amended ...... 66574 nated as new (e); new (d) added; 522.970 (b)(2) and (4) revised...... 6994 (a), new (e)(1)(i), (iii), (2)(i), (b)(1) and (4) revised...... 34236 (iii), (3)(i), (ii) and (4)(i) re- 522.1004 (b) amended...... 26952 vised...... 17770 (b) amended ...... 61516 (b) revised ...... 47725 520.905b (b) amended ...... 61516 522.1010 (b)(4) amended...... 61516 520.905c (b) amended ...... 61516 522.1078 (b) amended...... 61516 520.905d (b)(1) amended ...... 61516 522.1079 (b) amended...... 61516 520.905e (b) amended ...... 61516 522.1081 Revised ...... 61516 520.1010 (b)(2) amended...... 61516 522.1160 (b) amended...... 61517 520.1192 (b)(3), (e)(1)(ii)(A) and (B) (a), (b) and (c)(2)(i) revised ...... 66048 removed; (b)(1), (2) and (e)(1)(ii) 522.1192 (b)(2) amended ...... 9049 revised ...... 6542 522.1222a (b) amended...... 36111, 66573 520.1200 (b) amended...... 61516 522.1290 Heading, (a), (b) and (d) 520.1372 Added ...... 27707 amended...... 25146 520.1390 Removed...... 36111 522.1850 (a) revised ...... 67816 520.1498 Removed...... 36111 522.2112 (b) amended...... 53164 520.1720a (a) and (b)(3) revised; 522.2476 (a)(2) amended...... 61517 (b)(6) added...... 1146 522.2477 (b)(2) amended...... 61517 520.2220a (a)(2) amended...... 60156 522.2630 (d)(1)(ii) and (2)(ii) re- 520.2261a (a) amended...... 36112 vised...... 53165

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21 CFR—Continued 74 FR 21 CFR—Continued 74 FR Page Page Chapter I—Continued Chapter I—Continued 522.2640 Removed; new 522.2640 re- 589.2001 Regulation at 73 FR 22756 designated from 522.2640a; confirmed...... 18626 heading and (e)(1)(ii) amended; Technical correction ...... 20583 (c) removed...... 11644 522.2640a Redesignated as 2010 522.2640 ...... 11644 21 CFR 75 FR 524.590 (b) amended ...... 26782 Page (c)(3) amended...... 47436 Chapter I 524.1044f (b) amended ...... 22822 510.600 (c)(1) table and (2) table 524.1193 (b) amended...... 36112 amended ...... 3159 524.1195 (b) amended...... 26782 514.1 Regulation at 74 FR 54751 524.1580b (b)(3) added; (d)(3) re- confirmed...... 10413 vised...... 38342 516.3 (b) amended ...... 69588 524.2098 (d)(2) amended...... 19878 516.20 (b)(2) revised ...... 69588 526.1696a (c) amended...... 18990 520.23 Revised ...... 10165 528 Added ...... 6823 520.314 Revised ...... 10165 Heading corrected; CFR correc- 520.315 Removed ...... 10165 tion...... 58205 520.390b (b) revised...... 55676 529.1186 (b) amended...... 68530 520.580 (b)(1) amended ...... 52622 529.1455 Added ...... 9767 520.645 (b) amended; (d)(1)(i) and 529.1940 Revised ...... 59074 (iii) revised ...... 10165 529.2150 (c)(1) amended...... 10484 520.766 Added ...... 67031 558.55 (d)(2)(iv) table amended...... 61028 520.870 (b) amended; (d)(1)(i) and 558.58 (e)(1)(iii) table corrected; (iii) revised ...... 10166 CFR correction...... 13114 520.1130 Revised ...... 10166 (a)(3), (b)(1) and (2) removed; (b) 520.1130a Removed ...... 10166 revised; (e)(1)(i), (ii) and (iii) 520.1130b Removed ...... 10166 amended ...... 61028 520.1130c Removed ...... 10166 558.128 (e)(2)(iii) table amend- 520.1448a (c)(2) amended ...... 66305 ed ...... 27920 520.1616 Heading revised...... 26646 558.175 (b) and (d) table amend- 520.1618 Added ...... 26646 ed ...... 61028 520.1630 (b) amended...... 10166 558.258 (b) and (e)(1) table through 520.1871 (a)(1), (d)(1)(i) and (iii) re- (5) table amended...... 61517 vised; (b)(1) amended...... 54018 520.2043 (b)(2) amended...... 52622 558.311 (e)(1)(xv) amended ...... 34237 520.2200 Revised ...... 10166 558.342 (e)(1)(x) added ...... 59911 520.2200a Removed ...... 10166 (e)(1)(xi) added ...... 61029 520.2200b Removed ...... 10166 558.355 (f)(3)(ii)(b) revised...... 52885 520.2200c Removed ...... 10166 558.455 (d) redesignated as (e); new 520.2215 (b) amended...... 69586 (d) added; (b) and new (e) re- 520.2260a (a)(1) amended...... 10166 vised...... 40724 520.2261a (a) amended; (d) re- 558.500 (e)(1)(ii) and (iii) revised; moved ...... 10166 (e)(1)(iv) added...... 66914 520.2261b (b) amended...... 10166 558.555 (e)(2), (3) and (4) added ...... 41631 520.2320 Removed...... 65565 558.600 (d)(2) and (e)(1)(i) re- 520.2345d (b)(3), (d)(1)(iii) and vised...... 6 (2)(iii) amended ...... 10166 558.625 (c)(2)(i) removed; (c)(3) (b)(2) and (3) revised; (b)(4) re- amended...... 52885 moved; (b)(5) redesignated as 558.625 (f)(1)(vi)(b) amended; new (b)(4) ...... 12981 (f)(1)(vi)(d)(vi) removed...... 66915 520.2455 (a) and (b) revised ...... 54492 558.665 (b) and (e) table amend- 520.2481 Removed...... 10166 ed ...... 61517 520.2482 Removed...... 10166 589.2000 Regulation at 73 FR 22756 520.2483 Added ...... 10166 confirmed...... 18626 520.2640 (a), (b) and (d)(3)(ii) re- Technical correction ...... 20583 vised...... 76259

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21 CFR—Continued 75 FR 21 CFR—Continued 75 FR Page Page Chapter I—Continued Chapter I—Continued 522.23 Revised ...... 10167 529.2150 (b) amended ...... 1021 522.90b Heading and (b)(1) amend- 556.30 Removed...... 65565 ed ...... 10167 556.90 Removed...... 24394 522.246 (b)(2) amended ...... 22524 556.220 Removed ...... 65566 522.313a (e)(3) added...... 4692 556.680 Removed ...... 65566 (e)(1)(ii) amended; (e)(3) revised 558.4 (d) table amended ...... 24394, 34361, ...... 62468 65566 522.533 Heading and (b) revised; 558.15 (g)(2) removed; eff. 4–30– (c) added; (d) removed ...... 52622 10...... 16002 Revised...... 81456 558.35 Removed...... 65566 522.558 (c)(2)(ii) revised ...... 60308 558.55 (d)(2) table footnote 1 cor- 522.775 (b) amended ...... 10167 rectly reinstated; CFR correc- 522.870 (b) amended ...... 10167 tion ...... 15610 522.930 Added ...... 59611 558.128 (b)(2) revised ...... 9334 522.956 Added ...... 1275 558.185 (b)(2) removed; (b)(3) re- (d)(2) revised ...... 54019 designated as new (b)(2)...... 24394 522.970 (b)(1) and (4) revised ...... 13225 558.315 Removed ...... 65566 (b), (e)(1)(iii) and (2) revised ...... 76260 558.325 (a) and (c)(3)(ii) revised; 522.1145 (f)(3)(iii) amended...... 1274 (d)(2)(i) table and (iii) table (c)(2) amended...... 10167 amended...... 55676 522.1192 (b)(1), (2) and (e)(2)(ii) re- 558.342 (e)(1)(v), (vi) and (vii) vised...... 26647 amended...... 60309 522.1222a (b) amended...... 10167 558.366 (d) table amended ...... 7555 522.1696a (b)(1), (2), (d)(2)(ii)(A) 558.376 Removed ...... 65566 and (iii) revised...... 54017 558.485 (b)(3) amended ...... 55677 522.1696b (b)(1), (2), (d)(2)(i)(A) and 558.500 (e)(2) table amended; (iii)(B) revised ...... 54017 (e)(2)(xi) added ...... 1276 522.2005 Revised ...... 20269 (e)(3)(iii) and (iv) added ...... 5888 (b) and (c) revised ...... 38700 (e)(2)(viii) amended; (e)(2)(xii) 522.2200 Revised ...... 10167 removed...... 20917 522.2260 (d) removed; (e) redesig- (e)(2)(xii) and (xiii) added ...... 54019 nated as new (d); heading, (a), 558.630 (b)(5) amended ...... 55677 (b), new (d) introductory text 558.665 (e)(2) table, (4) table and (6) and (1) revised...... 10167 table amended ...... 11451 522.2471 (e)(1)(i), (ii) and (iii) re- 573.170 Added ...... 41725 vised ...... 9334 522.2483 Revised ...... 10167 2011 522.2662 (b)(2) amended...... 10167 524.1044i Added ...... 54492 21 CFR 76 FR 524.1193 (b) and (e)(2) revised...... 26648 Page 524.1445 Added ...... 4693 Chapter I 524.1465 (b) amended...... 79296 500.1410 (Subpart F) Added ...... 72618 524.1610 Added ...... 16346 501.22 (k) added ...... 71254 524.2481 Redesignated as 510.600 (c)(1) table and (2) table 524.2483 ...... 10168 amended ...... 2807, 2808, 6327, 11331 524.2483 Bedesignated from (c)(1) table and (2) table correctly 524.2481; (b) amended ...... 10168 amended ...... 16532 526 Heading revised...... 71017 (c)(1) table and (2) table amend- 526.363 (b) amended ...... 10168 ed; eff. 4–11–11 ...... 17777, 39278, 40612, 526.365 (b) amended ...... 10168 79064 526.464a Heading and (c) re- 516.3 Regulation at 75 FR 69588 eff. vised...... 10168 date confirmed ...... 11331 (c) revised ...... 71017 516.20 Regulation at 75 FR 69588 526.1130 (b) and (c)(3) amended ...... 10168 eff. date confirmed...... 11331 529.536 Added ...... 21163 516.157 (a) amended ...... 31470 529.1940 (d)(2) and (e)(1) revised; 516.1318 Added ...... 6327 (e)(2)(iii) amended ...... 63085 520.100 (b)(4) added ...... 38554

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21 CFR—Continued 76 FR 21 CFR—Continued 76 FR Page Page Chapter I—Continued Chapter I—Continued (b)(4) revised ...... 40808 520.2345d (b)(2) and (d)(2)(iii) cor- 520.154a Heading, (d)(1)(i), (2)(i), rectly revised; (d)(1)(iii) cor- (ii), (A) and (4)(i) correctly re- rectly amended...... 17338 vised...... 53050 520.2640 (a), (b)(1), (2), (d)(2)(ii), 520.441 Redesignated from (3)(ii)(A), (B) and (iii) revised; 520.445b; (b)(2) and (3) revised; (b)(3) added ...... 59024 (d)(4)(iii)(C) amended...... 49963 522.56 Correctly revised ...... 17338 520.443 Redesignated from 522.90b Heading, (a), (b) and (d) 520.445c; (d) removed; (e) redes- correctly revised ...... 17338 ignated as new (d); (a), (b) and (d)(2)(iii) correctly revised ...... 53051 new (d) introductory text re- 522.313b (a) correctly revised...... 17338 vised...... 49963 522.812 (e)(2)(ii) revised ...... 22611 520.445 Revised ...... 49649 522.814 Added ...... 72618 520.445a Removed ...... 49649 522.1002 (a)(2) amended ...... 2808 520.445b Redesignated as 522.1010 (d)(3)(iii) correctly redes- 520.441...... 49649 ignated as (d)(2)(iii); new 520.445c Redesignated as (d)(3)(iii) correctly added ...... 17338 520.443...... 49649 522.1014 Added ...... 57906 522.1081 (b)(2) amended; eff. 4–11– 520.522 (a) and (d) revised...... 78815 11...... 17778 520.550 Heading, (a) AND (c)(3) 522.1083 Added ...... 27889 correctly revised; (c)(1) cor- Heading and (a) correctly revised rectly amended...... 17336 ...... 53051 520.622a (a)(1) removed; (a)(5) 522.1192 (b)(2) revised ...... 57906 amended; (b)(2) revised; eff. 4– 522.1410 Heading, (a) and (d) cor- 11–11 ...... 17777 rectly revised; (c) correctly re- 520.622c (b)(1) and (7) removed; moved ...... 53051 (c)(3) revised; eff. 4–11–11 ...... 17777 522.1450 (d) redesignated as (e); 520.852 Added ...... 78150 new (d) added; (b) and new (e)(1) 520.905a (e)(2)(i), (iii), (3)(i) and and (3) revised...... 48714 (iii) correctly revised...... 17336 522.1664 Added ...... 3489 520.905c (e)(2)(iii) correctly re- 522.2240 (e)(3) correctly revised .....17027 vised...... 17337 522.2260 (a), (d)(1) and (3) correctly 520.970 Correctly revised...... 53051 revised ...... 53051 520.970a Correctly removed...... 53051 522.2690 (b) amended...... 79064 520.970b Correctly removed...... 53051 524.520 Removed; eff. 4–11–11...... 17778 520.1422 (b) correctly revised ...... 17337 524.814 Revised ...... 72619 520.1660d (b)(6) amended...... 17026 524.1132 Added ...... 78150 520.1720a (b)(6) revised ...... 11331 524.1193 (b)(1) and (2) amended ...... 81807 (b)(4) removed; eff. 4–11–11 ...... 17777 524.1450 Redesignated from 520.2043 (d)(1)(iii) correctly re- 524.1451; (a), (b) and (e)(1) revised...... 17337 vised...... 48715 520.2044 (d)(2) correctly revised .....17337 524.1451 Redesignated as 520.2045 (b)(2) amended...... 40229 524.1450 ...... 48715 520.2075 Added ...... 18648 524.1580c (b) amended; eff. 4–11– 520.2134 Added ...... 12563 11...... 17778 520.2220a (d)(3)(ii) correctly re- 556.227 (b) revised; (c) added...... 72619 vised...... 17337 556.292 Added ...... 57907 520.2220b (d) correctly revised ...... 17337 526.363 (d)(1) correctly revised; 520.2260a (a)(3)(iii) correctly re- (d)(3) correctly amended ...... 17338 vised...... 17337 529.536 (c)(3) correctly amend- 520.2261a Heading and (c)(3) cor- ed ...... 16533 rectly revised; (c)(2)(iii) cor- 529.50 Correctly redesignated as rectly amended...... 17337 529.56 and revised ...... 17339 520.2261b (d)(1)(ii) and (4)(iii) cor- 529.56 Correctly redesignated rectly revised ...... 17338 from 529.50 and revised ...... 17339

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21 CFR—Continued 76 FR 2012 Page 21 CFR 77 FR Chapter I—Continued Page 529.1030 (d)(1)(i) and (iv) correctly Chapter I revised ...... 17339 500 Authority citation revised ...... 50593 529.1186 (b) correctly amended ...... 16533 500.82 (b) amended ...... 50593 529.1660 (b)(2) amended...... 17026 500.84 (c) introductory text re- 529.2150 (b) correctly amended ...... 16533 vised...... 50593 556.20 Removed...... 16291 500.1410 (a) correctly amended ...... 9528 556.140 Removed ...... 16291 510.600 (c)(1) table and (2) table 556.240 Removed ...... 16291 amended ...... 4224, 4896, 5700, 26697, 556.270 Removed ...... 16291 29217, 31723, 32012, 32898, 46613, 47512, 556.283 Revised ...... 16291 55414, 56769, 60302, 60623, 64716 556.286 (b)(1)(iii) and (c) re- 511.1 (b)(4) introductory text, vised...... 16291 (5)(iii), (6), (8)(ii), (9)(i), (d)(2) and (f)(1) amended; (c) re- 556.290 Removed ...... 16291 vised...... 25359 556.320 Removed ...... 16291 511.3 Added ...... 25360 556.390 Removed ...... 16291 516.20 (b)(2) correctly revised; 556.400 Removed ...... 16291 CFR correction...... 18685 556.520 Removed ...... 16291 516.1215 Removed...... 32012 556.530 Removed ...... 16291 516.1318 (c)(2) revised ...... 35837 556.540 (b) removed...... 16291 520.48 (b) revised ...... 32012 Revised...... 57907 520.100 (b)(4) revised...... 55415 556.550 Removed ...... 16291 520.376 Added ...... 47512 520.390a Revised ...... 4896 556.590 Removed ...... 16291 520.441 (b)(4) amended...... 5700 558.4 (d) table correctly amend- 520.538 (a), (d)(1) and (2) reed ...... 16534, 17027 vised ...... 3928 (d) table amended...... 76894 520.622a (a)(4) removed ...... 4896 558.55 (d)(2)(i) table, (ii) table and 520.622b (b) removed ...... 4897 (iv) table correctly amend- 520.1044c Revised...... 4226 ed ...... 17027 520.1100 (b)(2) amended...... 28253 558.60 Correctly removed ...... 17027 520.1242 Heading revised ...... 28253 558.342 (d)(2) revised; (e)(1) table 520.1242a Heading(V); (b)(4) amended...... 60721 amended...... 28253 520.1263 Heading revised ...... 20988 (e)(1) table amended ...... 65110 520.1263c Heading and (b) re- 558.355 (f)(3)(x) introductory text vised...... 20988 and (b) revised...... 79065 (b) revised; (d)(3) added ...... 29217 558.485 Heading and (b)(3) re- 520.1265 (b)(2) amended...... 56770 vised...... 11331 520.1441 Redesignated from (b)(3) amended; eff. 4–11–11 ...... 17778 52.1445; heading revised ...... 47512 558.530 (d)(4)(i) and (xvii) cor- 520.1443 Redesignated from rectly removed ...... 16534 52.1446; heading revised ...... 47512 558.579 Correctly removed...... 17027 520.1445 Redesignated as 520.1441; 558.618 (a), (c) and (e) revised ...... 76894 new 520.1445 added ...... 47512 558.625 (b)(8), (38) and (80) re- 520.1446 Redesignated as moved ...... 11331 520.1443 ...... 47512 520.1447 Added ...... 4225 (b)(42) and (45) removed; eff. 4–11– 520.1448 Removed...... 58021 11 ...... 17778 520.1448a Removed...... 58021 558.630 (b)(4) removed; (b)(5) 520.1660d (b)(5), (d)(1)(ii)(A)(3), amended; eff. 4–11–11 ...... 17778 (B)(3), (C)(3) and (iii)(C) amend- 558.680 (d)(1)(i) table, (ii) table ed ...... 28253 and (iii) table correctly amend- 520.1696 Heading revised...... 20988 ed ...... 17027 520.1696a Removed ...... 20988 573.480 Revised ...... 7106 520.1696b Heading, (a), (b) and (c) heading revised ...... 20988

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21 CFR—Continued 77 FR 21 CFR—Continued 77 FR Page Page Chapter I—Continued Chapter I—Continued 520.1696c Heading revised; (c) re- 524.916 Added ...... 47512 moved ...... 20988 524.1044c (b) amended...... 64717 520.1696d Heading and (b) revised; 524.1044f (b) and (c)(2) revised ...... 3598 (c) removed...... 20988 524.1445 (b) revised ...... 46613 520.1705 Added ...... 15960 524.1484a Removed ...... 4897 520.1720c (b)(1) amended ...... 4897 524.1484j Removed ...... 4897 520.1760 Added ...... 15961 524.1484k Removed ...... 4897 520.1860 Added ...... 76863 524.1880 Removed ...... 4897 520.2130 Revised ...... 60623 524.2483 (b) amended...... 60302 520.2220a (a)(2) amended...... 56770 529.1350 Added ...... 76863 520.2345 Heading revised ...... 20988 529.1455 Removed ...... 4897 520.2345d (b)(4) revised ...... 20988 529.2620 Added ...... 64717 520.2455 (b)(2) amended...... 56770 530.41 (a)(13) added; eff. 4-5-12...... 745 520.2640 (b) introductory text re- 556.733 Added ...... 39391 vised...... 29217 556.748 Added ...... 55415 520.2645 Added ...... 55415 558.4 (d) Category I table and Cat- 522.52 Added ...... 64717 egory II table amended...... 22668 522.150 (b) amended ...... 46613 522.246 (b)(2) amended ...... 60302 (d) Category II table amended...... 24138 522.313a (e)(2)(i), (ii) and (iii) re- 558.261 (a)(2), (c)(2)(1) and (e)(2) vised...... 26162 table revised...... 32012 522.313c (b), (e)(2)(ii), (3)(ii), (4)(ii) 558.274 (a)(7) removed; (c)(1)(i) and (8)(i) revised ...... 29218 table and (ii) table amended...... 4897 522.522 (d)(1) and (2) revised...... 4227 558.342 (b)(2) and (e)(1) table 522.540 Heading, (a)(2)(ii) and amended...... 31723 (3)(iii) revised ...... 32012 (e)(1) table amended ...... 76864 522.1083 (c)(1) and (3) revised ...... 4227 558.355 (f)(3)(iv) added; (f)(3)(x)(c) 522.775 (b) amended ...... 60302 amended ...... 4228 522.812 (e)(2)(i), (ii)(A) and (iii) re- (d)(7)(vii), (10)(i) and (ii) revised; vised...... 55415 (f)(3)(v) removed; (f)(7) redesig- (e)(3)(ii) revised...... 76863 nated as (f)(8); new (f)(7) added 522.840 (b) amended ...... 31723 ...... 58021 522.842 (a)(2) amended ...... 31723 (f)(8)(iv) redesignated as (f)(8)(v); 522.1004 (b) revised ...... 26697 new (f)(8)(iv) added ...... 60623 522.1014 (d)(1)(ii) revised...... 26162 558.363 (d)(1)(i) introductory text 522.1081 (b)(2) removed ...... 55414 revised ...... 29218 522.1193 (b) revised ...... 64717 (d)(1)(xi)(B) revised; (d)(2) redes- 522.1315 (c) revised ...... 39391 ignated as (d)(3); (a)(8), (c) and 522.1462 Removed...... 55414 new (d)(2) added...... 64717 522.1642 Removed...... 55414 558.485 (b)(3) amended...... 4897 522.1680 (b) amended...... 55414 558.500 (e)(1)(i) correctly rein- 522.1696a (b)(1), (3), (d)(1)(iii) and stated; CFR correction ...... 14272 (2)(iii) revised...... 4897 (e)(2)(viii) and (x) amended ...... 31724 522.1940 (a)(2) amended...... 31723 558.600 (e)(1)(i) removed ...... 22668 522.2460 Added ...... 39391 (a) revised; (e)(1) table amended 522.2476 (b)(1) amended...... 31723 ...... 24139 522.2477 (b)(1) amended...... 31723 558.618 (c)(3)(ii) removed; (e) re- 524.154 (a)(2) and (b)(3) amend- vised...... 60623 ed ...... 64717 558.625 (b)(10), (12) and (67) re- 524.155 (a)(2) and (b)(3) amend- moved ...... 4897 ed ...... 64717 (b)(90) added ...... 26162 524.390 Revised ...... 4897 (b)(40) removed...... 60302 (b) amended ...... 64717 558.630 (b)(2) removed; (b)(5) 524.390a Removed...... 4897 amended ...... 4897 524.390b Removed...... 4897 558.665 (e)(2), (4) and (6) amend- 524.390d Removed...... 4897 ed ...... 31724

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2013 21 CFR—Continued 78 FR Page 21 CFR 78 FR Chapter I—Continued Page 520.1010 (b)(3) amended...... 17596 Chapter I 520.1044b (b) amended...... 17596 500.35 Removed...... 42451 520.1192 (b)(2) amended...... 17596 501 Small entity compliance 520.1193 (b)(2) amended...... 17596 guide ...... 59624 520.1195 (b)(1) amended...... 17596 510.600 (c)(1) table and (2) table 520.1350 Redesignated as amended ...... 5714, 17596, 17867 520.1367 ...... 57058 (c)(1) table amended ...... 14668 520.1367 Redesignated from (c)(1) table and (2) table amended 520.1350; (a) and (b) revised...... 57058 ... 19987, 21059, 27859, 44433, 52429, 52430, 520.1408 (b) amended; (c) re- 52853, 63871, 66264, 73698 moved ...... 21060 520 Drug application approvals 520.1484 (b)(3) amended...... 17596 withdrawn...... 78716 520.1604 Added ...... 42007 520.28 Redesignated from 520.1660d (b)(3), (d)(1)(ii)(A)(3), 520.44 ...... 66264 (B)(3) and (C)(3) amended ...... 21060 520.38 Redesignated from 520.1720a (b)(2) amended...... 17596 520.45 ...... 66264 (b)(2) amended...... 21060 520.38a Redesignated from 520.1870 (b)(2) amended...... 17596 520.45a ...... 66264 520.1900 (b) amended; (c)(1) foot- 520.38b Redesignated from note, (2) footnote and (3) foot- 520.45b ...... 66264 note removed...... 21060 520.43 Added ...... 66264 520.2043 (b)(1) amended...... 17596 520.44 Redesignated as 520.28 ...... 66264 520.2044 (b)(2) amended...... 17596 520.45 Redesignated as 520.38 ...... 66264 520.2087 Removed...... 78716 520.45a Redesignated as 520.38a...... 66264 520.2088 Removed...... 78716 520.45b Redesignated as 520.38b...... 66264 520.2089 Removed...... 78716 520.100 (b)(4) and (d)(1) introduc- 520.2123c (b) amended...... 17596 tory text revised...... 23 520.2220a (a)(1) amended...... 17596 (b)(3) amended...... 17596 (a)(1) amended...... 21060 (b)(2) revised ...... 57058 520.2260b (f)(1) amended ...... 17596 520.182 Removed ...... 14669 520.2325a (a)(1) amended...... 17596 520.260 Heading revised; (b)(1) and 520.2345d (b)(2) amended...... 21060 (3) revised ...... 14669 520.2612 Revised ...... 63872 520.309 (b)(2) amended ...... 52853, 66264 520.2455 (b)(2) revised; (b)(3) 520.370 (b) amended ...... 5714 added...... 17596 520.390a (b)(1)(i) amended...... 21059 522.23 (b)(2) amended...... 17597 520.441 (b)(3) amended ...... 21059 522.46 Removed...... 14669 520.443 (b) amended ...... 21059 522.56 (b) amended...... 17597 520.446 (b)(1) amended ...... 17596 522.246 (b)(2) and (3) amended...... 17597 520.447 (b) amended ...... 17596, 30197 522.313b (b), (d), (e)(2)(i) and (iii) 520.580 Heading, (a), (b), (d)(1) and revised ...... 66264 (2) revised ...... 14669 522.390 (b) amended ...... 17597 (b)(2) amended ...... 21059 522.540 (a)(2)(i), (b)(3)(i), (ii), 520.600 (c) amended ...... 21059 (c)(3)(i), (ii), (d)(2)(i) and (e)(2) 520.622a (a)(6) amended ...... 21059 amended...... 17597 520.622b (c)(2) amended ...... 21059 522.558 (a) revised...... 25183 520.622c (b)(6) amended ...... 21059 (a) correctly revised ...... 33699 520.763a (a) and (e) removed; (c) 522.810 (b) amended ...... 17597 amended...... 21059 522.812 (b) and (e)(3)(ii) revised; 520.763b (a) removed; (c) amend- (e)(2) introductory text ed ...... 21059 added...... 19987 520.763c (b) amended; (c) re- 522.1010 (b)(3) amended...... 17597 moved ...... 21059 522.1044 (b)(4) amended...... 17597 520.812 Revised ...... 30197 (b)(3) amended...... 21060 (a) and (b) revised ...... 52853 522.1066 (b) amended...... 17597 520.955 (b) amended ...... 52854 522.1073 Added ...... 17867

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21 CFR—Continued 78 FR 21 CFR—Continued 78 FR Page Page Chapter I—Continued Chapter I—Continued 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- 556.665 (e)(5) table amended...... 52854 vised...... 73698 556.733 (a) amended ...... 52854 522.1182 (b)(1), (6) and (7) amend- 558.62 (a)(1), (2), (c)(1)(i) and (ii) ed ...... 17597 removed; (c)(1)(iii), (iv), (v), (b)(3) and (8) amended ...... 44433 (vi) and (vii) amended...... 70496 522.1192 (b)(2) amended...... 17597 558.95 (a), (d)(1), (2), (3), (4)(i) and 522.1222a (b) amended...... 17597 (ii) revised ...... 52430 (b) amended ...... 21060 (d)(4)(iii) introductory text and 522.1260 (b)(2) amended...... 17597 (iv) introductory text revised; 522.1367 (b) amended ...... 5715 (d)(4)(iii)(d) amended ...... 76060 522.1410 (b) amended...... 21060 Technical correction ...... 79299 522.1660a (b) amended...... 17597 558.120 (a)(1) and (d)(1)(i) re- 522.1662a (i)(2) amended ...... 17597 moved ...... 69993 (a)(2), (b)(2), (g)(2) and (h)(2) 558.195 (e)(2)(v) table amended ...... 25183 amended ...... 21060 558.205 (a) amended ...... 21060 522.1680 (b) amended...... 17597 558.342 (e)(1)(iv) table and Heading revised; (b) amended ...... 21060 (e)(1)(ix) table amended ...... 25183 522.1696a (b)(2) amended...... 17597 558.355 (f)(3)(ix) removed; 522.1696b (b)(1), (d)(2)(i)(A) and (f)(3)(ii)(b) and (xii)(b) amend- (iii)(B) amended...... 17597 ed ...... 19987 522.1720 (b)(1) amended...... 17597 (f)(7)(iii)(a) amended ...... 27859 Heading revised; (b)(2) amended (f)(3)(iii) introductory text ...... 21060 amended ...... 66265 522.1870 Heading, (b), (c)(1)(iii) 558.366 (d) table amended ...... 23, 42007, and (2)(iii) revised ...... 17868 52429 522.2005 (b)(1) amended...... 17597 558.460 (d)(2)(iv) removed ...... 52430 (b)(2) amended...... 17868 558.485 (b)(6) amended ...... 14669 522.2120 (b) amended ...... 17597 (b)(3) amended ...... 52431 522.2220 (a)(2)(iii) amended...... 17597 558.500 (a), (b), (e)(1) table, (i) Heading revised; (c)(2) amended table, (2)(i) table, (vi) table and ...... 21060 (xi) table amended ...... 63872 522.2424 Heading revised; (b) 558.530 (a) and (b) removed; (d)(1), amended; (c)(4) removed ...... 21060 (2) and (3) tables revised ...... 69993 522.2483 (b) amended...... 21060 558.586 (b) amended ...... 17597 522.2615 (b) amended...... 17597 558.618 (b), (e)(1)(i) table, (ii) 522.2630 (a) and (b) revised ...... 63872 table, (2)(i) table, (ii) table and 522.2662 (b)(1) amended...... 21060 (iii) table amended...... 19987 524.916 (b) amended ...... 44433 558.625 (b)(35), (63), (66) and (77) re- 524.1044g (b)(3) amended...... 17597 moved ...... 14669 524.1146 (a)(2) and (d)(1)(ii) re- (b)(14) removed...... 52431 vised; (d)(3) added ...... 73698 558.630 (b)(5) added ...... 14669 524.1193 (b)(2) amended...... 17597 558.635 (a)(2) amended ...... 52431 b)(2) amended...... 63872 558.665 (e) table amended...... 42008 524.1465 (b) amended...... 52854 573.170 Introductory text cor- 524.1580b (b)(1) amended...... 21060 rectly revised ...... 42692 524.1580c (b) amended...... 21060 579.40 (a) revised ...... 27304 524.2482 (b) amended...... 17868 (a)(2), (3) and (4) correctly revised 526.1696b (b) amended...... 21060 ...... 34565

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2014 21 CFR—Continued 79 FR Page (Regulations published from January 1, Chapter I—Continued 2014, through April 1, 2014) 522.540 Heading, (a)(3)(iii), (b)(1), (3), (c)(1), (3), (d)(1), (3), (e)(1) 21 CFR 79 FR Page and (3) revised; (d)(2)(i) and (ii) amended...... 16186 Chapter I 522.542 Revised ...... 16186 510 Drug application approvals 522.563 Revised ...... 16186 withdrawn ...... 2786 522.650 (b), (c), (d)(1) and (3) re- 510.600 (c)(1) table and (2) table vised...... 16187 amended ...... 2786, 10964, 18157 522.690 (b) amended ...... 16187 514.11 (b), (d), (e) introductory 522.723 Revised ...... 16187 text and (e)(2)(ii) introductory 522.770 (a) and (b) amended ...... 16187 text revised; eff. 7-30-14 ...... 14611 522.778 Removed ...... 16187 516.1684 Added ...... 18158 522.784 Revised ...... 16187 520.1195 (b)(1) and (2) revised...... 10964 522.800 Revised ...... 16187 520.1780 (a) amended ...... 18158 522.820 (a) and (b) redesignated as 520.2075 (c)(2) amended...... 10964 (b) and (a); (d)(1) introductory 520.2220 (a)(1), (2) and (3)(iii) re- text, (2) introductory text and vised...... 10964 (3) introductory text re- 520.2471 Added ...... 18158 vised...... 16187 522.23 (b) and (c) revised; (d) and 522.842 (a)(1) amended ...... 16187 (e) removed...... 16182 522.863 Revised ...... 16187 522.44 Removed...... 16182 522.883 Revised ...... 16188 522.56 (b) revised ...... 16183 522.900 (b)(2) amended ...... 16188 522.62 Revised ...... 16183 522.914 Revised ...... 16188 522.82 Revised ...... 16183 522.955 (d)(1)(i)(C) and (ii)(C) re- 522.84 Revised ...... 16183 vised...... 18158 522.88 Revised ...... 16183 522.956 (d)(3) revised...... 18158 522.90 Revised ...... 16183 522.960 Revised ...... 16188 522.90a Revised ...... 16183 522.960a Revised...... 16188 522.90b Heading revised...... 16184 522.960b Revised...... 16188 522.90c (b) amended...... 16184 522.960c Revised...... 16188 522.144 Revised ...... 16184 522.970 (b)(2) amended ...... 16189 522.161 Revised ...... 16184 522.995 Revised ...... 16189 522.204 (b) amended ...... 16184 522.1010 (d)(2)(i)(B) and (ii)(B) re- 522.234 Revised ...... 16184 vised...... 16189 522.1020 Revised ...... 16189 522.246 (b)(1) amended ...... 16184 522.1066 (b) amended...... 16189 522.275 Heading revised ...... 16184 522.1081 (b)(1) amended...... 16189 522.300 Revised ...... 16185 522.1083 (b) and (c)(3) amended ...... 16189 522.304 (b) amended ...... 16185 522.1085 Revised ...... 16189 522.311 (b) amended ...... 16185 522.1086 Revised ...... 16189 522.313a (b) amended ...... 16185 522.1125 (d)(3) amended...... 16189 522.313c (b) amended ...... 16185 522.1145 Heading, (a)(3)(i), (iii), 522.380 Revised ...... 16185 (b)(3)(i), (iii), (c)(3), (d)(3)(iii), 522.390 Heading, (a), (b) and (c)(3) (f)(3)(i) and (iii) revised; (a)(2) revised ...... 16185 and (b)(2) amended ...... 16189 522.460 Revised ...... 16185 522.1150 Heading, (a) and (c)(3) re- 522.468 (b) amended ...... 16185 vised; footnote 1 removed...... 16190 522.480 Revised ...... 16185 522.1155 Revised ...... 16190 522.522 (b) amended ...... 16185 522.1156 Revised ...... 16190 522.533 (b)(1) amended ...... 18158 522.1182 (b)(2), (4) introductory 522.535 (d) redesignated as (c); text and (5) introductory text heading, (a) and new (c)(1)(iii) amended...... 16190 revised ...... 16185 522.1185 Added ...... 16190 522.536 Revised ...... 16186 522.1204 Revised ...... 16190

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21 CFR—Continued 79 FR 21 CFR—Continued 79 FR Page Page Chapter I—Continued Chapter I—Continued 522.1222 Removed; redesignated 522.1720 Revised ...... 16193 from 522.1222a; (b) amended ...... 16190 522.1820 Heading and (c) re- 522.1222a Redesignated as new vised...... 16193 522.1222 ...... 16191 522.1862 Revised ...... 16193 522.1222b Redesignated as 522.1881 Revised ...... 16194 522.1223 ...... 16191 522.1884 Revised ...... 16194 522.1223 Redesignated from 522.1885 Revised ...... 16194 522.1222b and revised ...... 16191 522.1890 Revised ...... 16194 522.1225 Revised ...... 16191 522.1920 Revised ...... 16194 522.1228 Removed...... 16191 522.1940 (a)(1) amended...... 16194 522.1242 Redesignated from 522.1962 Heading and (c)(1)(iii) re- 522.1244; heading revised; (a) vised; (b)(1) amended...... 16194 and (b) amended...... 16191 522.2002 Revised ...... 16195 522.1244 Redesignated as 522.2005 (b)(3) amended; (c)(3) 522.1242 ...... 16191 added...... 16195 522.1260 (b)(1) and (3) amended ...... 16191 522.2012 Revised ...... 16195 522.1289 Revised ...... 16191 522.2063 Revised ...... 16195 522.1315 (b) amended...... 16191 522.2076 (c)(3) revised ...... 16195 522.1335 Heading, (a) and (c)(3) re- 522.2100 Heading, (a)(1), (3), (b)(1), vised...... 16191 (3) and (d)(2) revised ...... 16195 522.1362 Heading, (c)(1) and (3) re- 522.2120 (b) amended...... 16195 vised...... 16191 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 522.2473 Added ...... 18159 522.1503 Heading, (a) and (c) re- 522.2474 Revised ...... 16197 vised...... 16192 522.2477 (b)(3) amended...... 16197 522.1610 Heading, (a) and (c) re- 522.2478 (b) amended...... 16197 vised...... 16192 522.2582 Revised ...... 16197 522.1620 (c) revised ...... 16192 522.2610 (b) amended; (c) removed; 522.1660a (b) and (e)(1)(ii) amend- (d) redesignated as new (c); new ed ...... 16192 (c)(1)(iii) added; new (c)(2)(iii) 522.1662a (c)(2), (d)(2), (e)(2) and revised ...... 16197 (h)(2) amended ...... 16192 522.2615 Heading, (a), (b) and (d) 522.1662b (b) amended...... 16192 revised ...... 16198 522.1664 (d)(3) revised ...... 16192 522.2640 (d) and (e) redesignated as 522.1680 (b) amended...... 16192 (c) and (d); (a), (b), new 522.1696 Revised ...... 16192 (d)(1)(iii), (3)(i) and (iii) re- 522.1696a (b)(1), (3) and (d)(2)(iii) vised...... 16198 amended...... 16192 522.2662 (d)(2)(iii) revised ...... 16198 522.1696b (b)(1), (d)(2)(i)(A) and 522.2670 Heading and (a) re- (iii)(A) amended ...... 16192 vised...... 16198 522.1696c (b) amended; (c) re- 524.86 Heading, (b) and (c)(3) removed; (d) redesignated as new vised...... 10967 (c)...... 16193 524.154 (a) and (b) redesignated as 522.1698 Heading, (a), (b), (c)(1)(i), (b) and (c); new (a) added; head- (iii), (2)(i) and (iii) revised ...... 16193 ing, (b) and (c) introductory 522.1704 Revised ...... 16193 text revised ...... 10967

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21 CFR—Continued 79 FR 21 CFR—Continued 79 FR Page Page Chapter I—Continued Chapter I—Continued 524.155 (a) and (b) redesignated as 524.1484c Heading, (b) and (c) re- (b) and (c); new (a) added; head- vised...... 10970 ing, (b) and (c) introductory 524.1484d Heading, (b) and (c) re- text revised ...... 10967 vised...... 10970 524.390 (b) and (c)(3) revised ...... 10967 524.1484e Heading, (b) and (c) re- 524.402 (b) amended ...... 10967 vised...... 10970 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 524.1580b Redesignated as 524.960 (b) amended; heading and 524.1580a; new section redesig- (c) revised...... 10968 nated from 524.1580c; (b) 524.981 Removed ...... 10968 amended; (c)(2) footnote 1 and 524.981a Heading, (c) introduc- (3) footnote 1 removed ...... 10971 tory text, (1) and (2) revised ...... 10968 524.1580c Redesignated as 524.981b Heading, (a), (c) intro- 524.1580b; new section redesig- ductory text, (1) and (2) re- nated from 524.1580e; heading vised...... 10969 revised; (c)(2) footnote 1 and (3) 524.981c Heading, (a), (c) intro- footnote 1 removed ...... 10971 ductory text, (1) and (2) re- 524.1580d Removed...... 10971 vised...... 10969 524.1580e Redesignated as 524.981d Revised...... 10969 524.1580c ...... 10971 524.981e Revised...... 10969 524.1600a Heading, (b) and (c)(3) 524.1005 (b)(1) and (c)(3) amend- revised ...... 10972 ed ...... 10969 524.1600b Heading and (c) re- 524.1044 Heading revised ...... 10969 vised...... 10972 524.1044b Heading revised...... 10969 524.1662 Heading revised...... 10972 524.1044c Heading revised...... 10969 524.1662a (b) amended; heading 524.1044d Heading and (c) re- and (c) revised...... 10972 vised...... 10969 524.1662b (b) amended; heading 524.1044e Heading and (c) re- and (c) revised...... 10972 vised...... 10969 524.1881 Removed...... 10972 524.1044g Second (b)(3) removed; 524.1881a Removed...... 10972 heading revised ...... 10969 524.1881b Removed...... 10972 524.1044h Heading revised; (c)(3) 524.1883 Removed...... 10972 added...... 10969 524.1982 (b) amended; heading and 524.1132 Heading revised ...... 10969 (c) revised...... 10972 524.1200a Revised ...... 10969 524.2098 (b) amended ...... 10972 524.1200b Revised ...... 10970 524.2350 Revised ...... 10972 524.1204 Revised ...... 10970 524.2620 Revised ...... 10973 524.1240 (b) revised ...... 10970 526.313 (b) amended ...... 10973 524.1446 Heading revised ...... 10970 (d) removed; (e) redesignated as 524.1465 (b) amended...... 10970 new (d); new (d)(1)(iii) and 524.1484b Heading, (b) and (c) re- (2)(iii) revised ...... 18159 vised...... 10970 526.464a (d) removed...... 10973

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21 CFR—Continued 79 FR 21 CFR—Continued 79 FR Page Page Chapter I—Continued Chapter I—Continued 526.464d Removed ...... 10973 558.95 (d)(5)(iii) through (x) redes- 526.820 (b) removed...... 10973 ignated as (d)(5)(iv) through 526.1130 Heading revised ...... 10973 (xi); new (d)(5)(iii) added ...... 10965 526.1590 (a)(2) and (b)(2) amended; (d)(5) revised ...... 10982 heading revised ...... 10973 558.120 Removed ...... 10982 526.1696c (b) amended...... 10965 558.128 (e)(7) revised ...... 10982 (b)(1), (e)(1) through (5) tables, 526.1696d (b) amended...... 10973 (6)(iv) and (5) amended...... 13544 526.1810 (b) amended...... 10973 558.140 (a) amended; (c)(3) re- 529 Drug application approvals vised...... 13544 withdrawn ...... 2786 558.145 (a)(1) and (2) amended...... 13544 529.40 (c) removed; (d) redesig- 558.155 (a)(1) and (2) amended...... 13545 nated as (c); new (c)(3) re- Removed...... 15541 vised...... 10973 558.175 (d)(9) redesignated as 529.56 (b) amended...... 10973 (d)(11); (d)(5) through (8) redes- 529.400 Heading revised; (b) ignated as (d)(6) through (9); amended; (c)(1) footnote, (2) new (d)(5) and (10) added ...... 10965 footnote and (3) footnote re- (d)(3) and (8) removed; (d)(4) moved ...... 10973 through (7) redesignated as 529.778 Added ...... 10973 (d)(3) through (6); (d)(9), (10) 529.1030 (d)(1)(i), (ii), (2)(i) and (ii) and (11) redesignated as (d)(7), removed; (d)(1)(iii), (iv), (v), (8) and (9)...... 10982 (2)(iii), (iv) and (v) redesig- (d) table and (6) amended ...... 13545 nated as (d)(1)(i), (ii), (iii), 558.195 (e)(1)(iv) and (v) removed; (2)(i), (ii) and (iii); new (d)(2)(ii) (e)(1)(vi) through (ix) redesig- and new (iii) revised...... 2786 nated as (e)(1)(iv) through 529.1044 Amended...... 10973 (vii) ...... 10982 529.1044a Heading and (b) re- (b), (e)(1) table, (2) table and (3) vised...... 10973 table amended...... 13545 529.1044b Heading and (c) re- (e)(1)(vii) correctly removed ...... 17860 vised...... 10973 558.198 (d)(1)(iii), (iv) and (vi) re- 529.1115 (b) and (c)(3) revised; moved; (d)(1)(v), (vii) and (viii) (c)(1) footnote, (2) footnote and redesignated as (d)(1)(iii), (iv) (3) footnote removed ...... 10973 and (v) ...... 10982 529.1660 (b)(1) and (2) amended ...... 10973 (d)(1) table and (2) table amended 529.1940 (b), (c) and (e)(1)(iii) ...... 13545 amended; (e)(1)(ii)(D) added ...... 10965 558.248 (d)(3) removed; heading re- Amended ...... 10974 vised...... 10982 529.2464 Revised ...... 10974 558.258 (e)(2)(ii) through (vii) ta- 529.2503 Revised ...... 2786, 10974 bles amended ...... 13545 558.261 (e)(2)(ii) and (iii) amend- 556 Drug application approvals ed ...... 18159 withdrawal...... 10974 558.265 (d)(1)(v), (viii) and (3)(ii) 556.60 Revised ...... 10979 removed ...... 10982 558 Drug application approvals 558.274 Revised ...... 10982 withdrawl...... 10974 558.305 (b) and (e) table amend- 558.4 (d) table amended ...... 10979, 15541 ed ...... 13545 558.55 (d)(1), (2) and (3) revised; 558.311 (e)(1)(ii) and (xv) amended; (d)(4) added ...... 10979 (e)(5) revised ...... 10983 558.58 (e) revised ...... 10980 (b)(1) through (4), (6), (7), (e)(1) 558.62 Removed...... 10982 table, (2)(v), (3)(v) and (4)(v) 558.76 (d)(3) revised ...... 10982 amended ...... 13545 (a) and (d)(1) table amended ...... 13544 558.325 (d)(3) revised...... 10983 558.78 (d)(3) revised ...... 10982 (a)(1), (c)(3)(i), (d)(1) table and (2) (b), (d)(1) table and (2)(ii) amend- table amended...... 13545 ed...... 13544 558.340 Heading revised ...... 10983

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21 CFR—Continued 79 FR 21 CFR—Continued 79 FR Page Page Chapter I—Continued Chapter I—Continued (a) amended ...... 13545 558.464 (a)(1) and (2) amended...... 13545 558.342 (b)(1) and (e)(1) table 558.485 (b)(7) and (e)(1)(xii)(C) amended...... 13545 amended...... 13546 558.348 (a) amended ...... 13545 558.500 (e)(2)(viii) and (x) amend- 558.355 (f)(1)(ii), (vii), (x), (xi), ed ...... 13546 (xii), (xv), (xvi), (xvii), (xviii), 558.515 (d) amended ...... 10983 (xix), (xx), (xxiii), (xxvi), (xxvii), second (4)(iv), (vi) and (a) and (d) table amended ...... 13546 (vii) removed ...... 10983 558.530 Removed ...... 10983 (b)(8), (9), (11), (f)(1)(iii)(b), 558.550 (d)(1)(ii), (iv), (v), (viii), (iv)(b), (v)(b), (vii)(b), (xiv)(b), (ix), (xii), (xiv), (xv), (xvii), (xxv)(b), (xxix)(b), (xxx)(b), (xviii), (xix), (xxiv), (3)(iv), (vi) (2)(ii)(b), (iii)(b), (4)(ii)(b), and (vii) removed ...... 10983 (iii)(b), (iv)(b) and (v)(b) (b)(1), (d)(1)(iii)(c), (vi)(c), amended; (f)(1)(i)(b) revised...... 13545 (vii)(c), (xiii)(c), (xvi)(c), (b)(3) correctly removed ...... 17860 (xx)(c), (xxi)(C), (xxii)(B), 558.363 (a)(2), (5), (6), (d)(1)(ii), (v), (xxiii)(b), (3)(ii)(B), (iii)(B), (vii), (viii), (ix), (3)(iii) and (iv) (v)(B) and (4)(i)(b) amended ...... 13546 removed; (d)(1)(iii) and (iv) re- (d)(1)(i)(c) and (2)(i)(c) amended designated as (d)(1)(ii) and (iii); ...... 18159 (d)(1)(vi) redesignated as 558.555 (d)(3), (4) and (8) removed; (d)(1)(iv); (d)(1)(x) and (xi) re- (d)(5), (6) and (7) redesignated designated as (d)(1)(v) and as (d)(3), (4) and (5)...... 10983 (vi) ...... 10983 (d)(2), (3), (4) and (8) amended ...... 13546 (a)(6), (7), (d)(1)(vi)(B) and (x)(B) 558.575 (d)(1)(ii) removed...... 10983 amended ...... 13545 (a)(1) amended...... 13546 558.364 (a) and (d) table amend- 558.582 (a) amended ...... 13546 ed ...... 13545 558.600 (e)(1)(iii) amended ...... 13546 558.366 (d) table amended .....10983, 13545 558.369 (a) amended ...... 13545 558.625 (b)(10) added; (b)(54) 558.415 (a) revised; (b) and (c) re- amended; (b)(57) and (83) redesignated as (c) and (d); new moved ...... 13546 (b) added ...... 13545 558.630 (b)(5) amended ...... 13546 558.430 (a) revised; (b) and (c) re- 558.635 (a)(2) amended ...... 13546 designated as (c) and (d); new (d)(4)(v), (vi) and (vii) correctly (b) added ...... 13545 revised...... 17860 558.460 (d)(2) removed...... 10983 558.680 (d) revised...... 10983 (b), (d)(1)(i) table, (ii) and (iii) (b) amended ...... 13546 amended ...... 13545 573.210 Added ...... 14176 Æ

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