Title 21—Food and Drugs

(This book contains parts 500 to 599)

Part

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

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

SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

Part Page 500 General ...... 5 501 Animal food labeling ...... 15 502 Common or usual names for nonstandardized animal foods ...... 32 507 Current good manufacturing practice, hazard analysis, and risk-based preventive controls for food for animals ...... 34 509 Unavoidable contaminants in animal food and food-packaging material ...... 68 510 New animal drugs ...... 72 511 New animal drugs for investigational use ...... 82 514 New animal drug applications ...... 87 515 Medicated feed mill license ...... 123 516 New animal drugs for minor use and minor species 128 520 Oral dosage form new animal drugs ...... 153 522 Implantation or injectable dosage form new animal drugs ...... 266 524 Ophthalmic and topical dosage form new animal drugs ...... 350 526 Intramammary dosage form new animal drugs ...... 377 528 New animal drugs in genetically engineered animals ...... 382 529 Certain other dosage form new animal drugs ...... 383 530 Extralabel drug use in animals ...... 391 556 Tolerances for residues of new animal drugs in food 397 558 New animal drugs for use in animal feeds ...... 412 564 [Reserved] 570 Food additives...... 533 571 Food additive petitions ...... 545 3

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Part Page 573 Food additives permitted in feed and drinking water of animals ...... 550 579 Irradiation in the production, processing, and handling of animal feed and pet food ...... 576 582 Substances generally recognized as safe ...... 577 584 Food substances affirmed as generally recognized as safe in feed and drinking water of animals ...... 601 589 Substances prohibited from use in animal food or feed ...... 603 590–599 [Reserved]

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

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

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

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

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

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

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

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

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

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purpose of § 500.84(c)(1), FDA will as- mainder of the requirements of this sume that this Sm will correspond to subpart. the concentration of residue in a spe- (c) For each sponsored compound cific edible tissue that corresponds to a that FDA decides should be regulated maximum lifetime risk of cancer in the as a carcinogen, FDA will either ana- test animals of 1 in 1 million. lyze the data from the bioassays using

So means the concentration of a res- a statistical extrapolation procedure as idue of carcinogenic concern in the outlined in paragraph (c)(1) of this sec- total human diet that represents no tion or evaluate an alternate procedure significant increase in the risk of can- proposed by the sponsor as provided in cer to the human consumer. For the § 500.90. In either case, paragraphs (c)(2) purpose of § 500.84(c)(1), FDA will as- and (3) of this section apply. sume that this So will correspond to (1) For each substance tested in sepa- the concentration of test compound in rate bioassays, FDA will calculate the the total diet of test animals that cor- concentration of the residue of carcino- responds to a maximum lifetime risk of genic concern that corresponds to a cancer in the test animals of 1 in 1 mil- maximum lifetime risk to the test ani- lion. mal of 1 in 1 million. FDA will des- Sponsor means the person or organi- ignate the lowest value obtained as So. zation proposing or holding an ap- Because the total diet is not derived proval by FDA for the use of a spon- from food-producing animals, FDA will sored compound. make corrections for food intake. FDA Sponsored compound means any drug will designate as Sm the concentration or food additive or color additive proof residue in a specific edible tissue posed for use, or used, in food-pro- corresponding to a maximum lifetime ducing animals or in their feed. risk of cancer in test animals of 1 in 1 Target animals means the production million. class of animals in which a sponsored (2) From the appropriate residue compound is proposed or intended for chemistry data FDA will calculate the use. Rm as described in § 500.86(c). The sponsor 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; 84 FR 32992, July 11, 2019] 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

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residue of carcinogenic concern is at or the requirements to a particular com- below Sm. pound. The petition shall explain and (c) From these data, FDA will select document why the requirements from a target tissue and a marker residue which a waiver is requested are not and designate the concentration of reasonably applicable to the com- 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 or eggs must be the target tissue in ad- (Approved by the Office of Management and 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 § 500.88 Regulatory method. petitions, and color additive petitions 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 R . FDA will deter- m 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 409(c)(3)(A), 512(d)(1)(I), and 721(b)(5)(B) Subpart F—Methods for Detection of the act. of Residues of Carcinogenic (Approved by the Office of Management and Compounds Used in Food- Budget under control number 0910–0228) Producing Animals [52 FR 49586, Dec. 31, 1987, as amended at 67 FR 78174, Dec. 23, 2002] SOURCE: 76 FR 72618, Nov. 25, 2011, unless otherwise noted. § 500.90 Waiver of requirements. In response to a petition or on the § 500.1410 N-methyl-2-pyrrolidone. Commissioner’s own initiative, the (a) Standard for residues. No residues Commissioner may waive, in whole or of n-methyl-2-pyrrolidone may be in part, the requirements of this sub- found in the uncooked edible tissues of part except those provided under cattle as determined by a method enti- § 500.88. A petition for this waiver may tled ‘‘Method of Analysis: N-methyl-2- be filed by any person who would be ad- pyrrolidone,’’ September 26, 2011, Cen- versely affected by the application of ter for Veterinary Medicine, Food and

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Drug Administration, which is incor- Subparts C–E [Reserved] porated by reference with the approval of the Director of the Federal Register Subpart F—Exemptions From Animal Food under 5 U.S.C. 522(a) and 1 CFR part 51. Labeling Requirements To obtain a copy of the analytical 501.100 Animal food; exemptions from label- method, please submit a Freedom of In- ing. formation request to: https:// 501.103 Petitions requesting exemptions www.accessdata.fda.gov/scripts/foi/ from or special requirements for label FOIRequest/requestinfo.cfm; or go to: declaration of ingredients. https://www.fda.gov/about-fda/center-vet- 501.105 Declaration of net quantity of con- erinary-medicine/cvm-foia-electronic-read- tents when exempt. 501.110 Animal feed labeling; collective ing-room. You may inspect a copy at names for feed ingredients. the office of the Dockets Management Staff (HFA–305), Food and Drug Admin- AUTHORITY: 15 U.S.C. 1453, 1454, 1455; 21 istration, 5630 Fishers Lane, Rm. 1061, U.S.C. 321, 331, 342, 343, 348, 371. Rockville, MD 20852, 301–827–6860, be- SOURCE: 41 FR 38619, Sept. 10, 1976, unless tween 9 a.m. and 4 p.m., Monday otherwise noted. through Friday or at the National Ar- chives and Records Administration Subpart A—General Provisions (NARA). For information on the availability of this material at NARA, email § 501.1 Principal display panel of pack- [email protected], or go to: age form animal food. www.archives.gov/federal-register/cfr/ibr- The term principal display panel as it locations.html. applies to food in package form and as (b) Related conditions of use. See used in this part, means the part of a §§ 522.814 and 522.955 of this chapter. label that is most likely to be displayed, presented, shown, or examined [76 FR 72618, Nov. 25, 2011, as amended at 77 under customary conditions of display FR 9528, Feb. 17, 2012; 85 FR 18117, Apr. 1, 2020] for retail sale. The principal display panel shall be large enough to accommodate all the mandatory label infor- PART 501—ANIMAL FOOD mation required to be placed thereon LABELING by this part with clarity and conspicuousness and without obscuring design, Subpart A—General Provisions vignettes, or crowding. Where packages Sec. bear alternate principal display panels, 501.1 Principal display panel of package information required to be placed on form animal food. the principal display panel shall be du- 501.2 Information panel of package for ani- plicated on each principal display mal food. panel. For the purpose of obtaining 501.3 Identity labeling of animal food in uniform type size in declaring the package form. quantity of contents for all packages of 501.4 Animal food; designation of ingredi- substantially the same size, the term ents. area of the principal display panel means 501.5 Animal food; name and place of busi- the area of the side or surface that ness of manufacturer, packer, or distributor. bears the principal display panel, 501.8 Labeling of animal food with number which area shall be: of servings. (a) In the case of a rectangular pack- 501.15 Animal food; prominence of required age where one entire side properly can statements. be considered to be the principal dis- 501.17 Animal food labeling warning state- play panel side, the product of the ments. height times the width of that side; 501.18 Misbranding of animal food. (b) In the case of a cylindrical or nearly cylindrical container, 40 percent Subpart B—Specific Animal Food Labeling of the product of the height of the con- Requirements tainer times the circumference; 501.22 Animal foods; labeling of spices, (c) In the case of any otherwise flavorings, colorings, and chemical pre- shaped container, 40 percent of the servatives. total surface of the container: Provided,

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however, That where such container ously, but in no case may the letters presents an obvious principal display and/or numbers be less than 1⁄16 inch in panel such as the top of a triangular or height unless an exemption pursuant circular package, the area shall consist to paragraph (f) of this section is estab- 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 in § 501.1 is less than 10 square inches. § 501.2 Information panel of package (iii) The label information includes a for animal food. full list of ingredients in accordance (a) The term information panel as it with regulations in this part. applies to packaged food means that (iv) The information required by part of the label immediately contig- paragraph (b) of this section appears on uous and to the right of the principal the principal display panel or informa- display panel as observed by an indi- tion panel label in accordance with the vidual facing the principal display provisions of this paragraph (c) except panel with the following exceptions: that the type size is not less than 3⁄64 (1) If the part of the label imme- inch in height. diately contiguous and to the right of (2) Packaged foods are exempt from the principal display panel is too small the type size requirements of this para- to accommodate the necessary infor- graph: Provided, That: mation or is otherwise unusable label (i) The package is designed such that space, e.g., folded flaps or can ends, the it has a single obvious principal display panel immediately contiguous and to panel as this term is defined in § 501.1 the right of this part of the label may and has no other available surface area be used. for an information panel or alternate (2) If the package has one or more al- principal display panel. ternate principal display panels, the in- (ii) The area of surface available for formation panel is immediately contig- labeling on the principal display panel uous and to the right of any principal of the package as this term is defined display panel. in § 501.1 is less than 12 square inches (3) If the top of the container is the and bears all labeling appearing on the principal display panel and the pack- package. age has no alternate principal display (iii) The label information includes a panel, the information panel is any full list of ingredients in accordance panel adjacent to the principal display with regulations in this part. panel. (iv) The information required by (b) All information required to ap- paragraph (b) of this section appears on pear on the label of any package of the single, obvious principal display food pursuant to §§ 501.4, 501.5, 501.8 and panel in accordance with the provisions 501.17 shall appear either on the prin- of this paragraph (c) except that the cipal display panel or on the informa- type size is not less than 1⁄32 inch in tion panel, unless otherwise specified height. by regulations in this chapter. (3) Packaged foods are exempt from (c) All information appearing on the the type size requirements of this para- principal display panel or the informa- graph: Provided, That: tion panel pursuant to this section (i) The package is designed such that shall appear prominently and conspicu- it has a total surface area available to

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bear labeling of less than 12 square § 501.3 Identity labeling of animal food inches. in package form. (ii) The label information includes a (a) The principal display panel of a full list of ingredients in accordance food in package form shall bear as one with regulations in this part. of its principal features a statement of (iii) The information required by the identity of the commodity. paragraph (b) of this section appears on (b) Such statement of identity shall the principal display panel or informa- be in terms of: tion panel label in accordance with the (1) The name now or hereafter speci- provisions of this paragraph (c) except fied in or required by any applicable Federal law or regulation; or, in the that the type size is not less than 1⁄32 inch in height. absence thereof, (2) The common or usual name of the (d) All information required to ap- food; or, in the absence thereof, pear on the principal display panel or (3) An appropriately descriptive on the information panel pursuant to term, or when the nature of the food is this section shall appear on the same obvious, a fanciful name commonly panel unless there is insufficient space. used by the public for such food. In determining the sufficiency of the (c) Where a food is marketed in var- available space, any vignettes, design, ious optional forms (whole, slices, and other nonmandatory label informa- diced, etc.), the particular form shall tion shall not be considered. If there is be considered to be a necessary part of insufficient space for all of this infor- the statement of identity and shall be mation to appear on a single panel, it declared in letters of a type size bear- may be divided between these two pan- ing a reasonable relation to the size of els except that the information re- the letters forming the other compo- quired pursuant to any given section or nents of the statement of identity; ex- part shall all appear on the same panel. cept that if the optional form is visible A food whose label is required to bear through the container or is depicted by the ingredient statement on the prin- an appropriate vignette, the particular cipal display panel may bear all other form need not be included in the state- information specified in paragraph (b) ment. This specification does not affect of this section on the information the required declarations of identity 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. (1) A food shall be deemed to be an chapter. imitation and thus subject to the re- [41 FR 38619, Sept. 10, 1976, as amended at 42 quirements of section 403(c) of the act FR 4716, Jan. 25, 1977; 42 FR 15675, Mar. 22, if it is a substitute for and resembles 1977] another food but is nutritionally inferior to that food.

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(2) A food that is a substitute for and identity that require labeling in com- resembles another food shall not be pliance with this part 501, except those deemed to be an imitation provided it exempted by § 501.100, shall be listed by 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 pursuant to part 502 of this chapter), standard of identity established pursu- and which complies with all of the ap- ant to section 401 of the Federal Food, plicable requirements of such regula- Drug, and Cosmetic Act, shall be des- tion(s), shall not be deemed to be an ignated in the statement of ingredients imitation. on the label of such food by either of (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.

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(6) Sweetcream buttermilk, con- the unreconstituted ingredient plus the centrated sweetcream buttermilk, re- weight of the quantity of water added constituted sweetcream buttermilk, to reconstitute that ingredient, up to 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 [41 FR 38619, Sept. 10, 1976, as amended at 42 be declared as cream. 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 (b) The requirement for declaration egg yolks. of the name of the manufacturer, pack- (13) A livestock or poultry feed may er, or distributor shall be deemed to be be declared by a collective name listed satisfied, in the case of a corporation, in § 501.110 if it is an animal feed within only by the actual corporate name, the meaning of section 201(w) of the act which may be preceded or followed by and meets the requirements for the use the name of the particular division of of a collective name as prescribed in the corporation. In the case of an indi- § 501.110 for certain feed ingredients. vidual, partnership, or association, the (14) [Reserved] name under which the business is con- (15) When all the ingredients of a ducted shall be used. wheat flour are declared in an ingre- (c) Where the food is not manufac- dient statement, the principal ingre- tured by the person whose name ap- dient of the flour shall be declared by pears on the label, the name shall be the name(s) specified in §§ 137.105, qualified by a phrase that reveals the 137.200, 137.220, 137.225 of this chapter, connection such person has with such i.e., the first ingredient designated in food; such as ‘‘Manufactured for the ingredient list of flour, or llllll,’’ ‘‘Distributed by bromated flour, or enriched flour, or llllll,’’ or any other wording self-rising flour is flour, white flour, that expresses the facts. wheat flour, or plain flour; the first in- (d) The statement of the place of gredient designated in the ingredient business shall include the street ad- list of durum flour is durum flour; the dress, city, state, and ZIP Code; how- first ingredient designated in the ingre- ever, the street address may be omitted dient list of whole wheat flour, or if it is shown in a current city direc- bromated whole wheat flour is whole tory or telephone directory. The re- wheat flour, graham flour, or entire quirement for inclusion of the ZIP wheat flour; and the first ingredient Code shall apply only to consumer designated in the ingredient list of commodity labels developed or revised whole durum wheat flour is whole after the effective date of this section. durum wheat flour. In the case of nonconsumer packages, (c) When water is added to reconsti- the ZIP Code shall appear either on the tute, completely or partially, an ingre- label or the labeling (including in- dient permitted by paragraph (b) of voice). this section to be declared by a class (e) If a person manufactures, packs, name, the position of the ingredient or distributes a food at a place other class name in the ingredient statement than his principal place of business, the shall be determined by the weight of label may state the principal place of

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business in lieu of the actual place or more parts or panels of the label, where such food was manufactured or each of which has sufficient space 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

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

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geographical words shall not be consid- Rosemary, Saffron, Sage, Savory, Star ani- ered deceptively misdescriptive if it: seed, Tarragon, Thyme, Turmeric. (i) Has been so long and exclusively Paprika, turmeric, and saffron or other used by a manufacturer or distributor spices which are also colors, shall be 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 subpart A of part 582 of this chapter, spices, flavorings, colorings, and and the substances listed in § 172.510 of chemical preservatives. 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 compliance with the requirements of sec- Allspice, Anise, Basil, Bay leaves, Caraway tion 403(k) of the act if it is not in seed, Cardamon, Celery seed, Chervil, Cin- package form and the units thereof are namon, Cloves, Coriander, Cumin seed, Dill 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; cannot be placed on such units with

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such conspicuousness as to render it the flavor shall be so labeled, e.g., arti- likely to be read by the ordinary indi- ficial strawberry flavor. vidual under customary conditions of (h) The label of a food to which flavor purchase and use. is added shall declare the flavor in the (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 pesticide chemical prior to harvest. monly understood by consumers to be 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 manufacturer or processor (but not a (4) Any salt (sodium chloride) used as consumer) for use in the manufacture an ingredient in food shall be declared of a fabricated food, unless it is a fla- by its common or usual name salt. vor for which a standard of identity (5) Any monosodium glutamate used has been promulgated, in which case it as an ingredient in food shall be de- shall be labeled as provided in the clared by its common or usual name standard: monosodium glutamate. (1) If the flavor consists of one ingre- (6) Any pyroligneous acid or other ar- dient, it shall be declared by its com- tificial smoke flavors used as an ingre- mon or usual name. dient in a food may be declared as arti- (2) If the flavor consists of two or ficial flavor or artificial smoke flavor. No more ingredients, the label either may representation may be made, either di- declare each ingredient by its common rectly or implied, that a food flavored or usual name or may state ‘‘All flavor with pyroligneous acid or other artifi- ingredients contained in this product cial smoke flavor has been smoked or are approved for use in a regulation of has a true smoked flavor, or that a sea- the Food and Drug Administration.’’ soning sauce or similar product con- Any flavor ingredient not contained in taining pyroligneous acid or other arti- one of these regulations, and any non- ficial smoke flavor and used to season flavor ingredient, shall be separately or flavor other foods will result in a listed on the label. smoked product or one having a true (3) In cases where the flavor contains smoked flavor. a solely natural flavor(s), the flavor (i) If the label, labeling, or adver- shall be so labeled, e.g., strawberry fla- tising of a food makes any direct or in- vor, banana flavor, or natural strawberry direct representations with respect to flavor. In cases where the flavor con- the primary recognizable flavor(s), by tains both a natural flavor and an arti- word, vignette, e.g., depiction of a fruit, ficial flavor, the flavor shall be so la- or other means, or if for any other rea- beled, e.g., natural and artificial straw- son the manufacturer or distributor of berry flavor. In cases where the flavor a food wishes to designate the type of contains a solely artificial flavor(s), flavor in the food other than through

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the statement of ingredients, such fla- name of the food and the name of the vor shall be considered the character- characterizing flavor shall be accom- izing flavor and shall be declared in the panied by the word(s) artificial or artifi- following way: cially flavored, in letters not less than (1) If the food contains no artificial one-half the height of the letters in the flavor which simulates, resembles or name of the characterizing flavor. 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 in the food is derived from the product need appear only once in each state- whose flavor is simulated, the food in ment of characterizing flavors present which the flavor is used shall be la- in such food. beled 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.

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All such certifications shall be re- expected to enable the Secretary’s rep- tained by the certifying party through- resentatives to determine which rel- out the period in which the flavor is evant raw and finished materials and supplied and for a minimum of 3 years flavor ingredient records are reason- thereafter, and shall be subject to the ably necessary to verify the certifi- following conditions: cations. The examination conducted by (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 provide such information is reasonably (j) A food to which a chemical pre- available at the time of inspection, the servative(s) is added shall, except when certifying party shall arrange to have exempt pursuant to § 501.100, bear a 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

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

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(2) Section 403(g)(2) of the act (requir- food will not be adulterated or mis- ing the label of a food which purports branded within the meaning of the act to be or is represented as one for which upon completion of such processing, la- a definition and standard of identity beling, or repacking. Such person and has been prescribed to bear the name of such operator shall each keep a copy of the food specified in the definition and such agreement until 2 years after the standard and, insofar as may be re- final shipment or delivery of such food quired by the regulation establishing from such establishment, and shall 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 ap- is adulterated or misbranded within propriate device bearing prominently the meaning of the act when so re- and conspicuously the common or moved. usual name of the food, or if the com- (2) An exemption of a shipment or mon or usual name of the food is clear- other delivery of a food under para- ly revealed by its appearance. graph (d)(2) of this section shall be- (c) [Reserved] come void ab initio with respect to the (d) Except as provided by paragraphs (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 (f) [Reserved] such person and such operator, and (g) The label declaration of a harm- containing such specifications for the less marker used to identify a par- processing, labeling, or repacking, as ticular manufacturer’s product may re- the case may be, of such food in such sult in unfair competition through re- establishment as will ensure, if such vealing a trade secret. Exemption from specifications are followed, that such the label declaration of such a marker

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is granted, therefore, provided that the weight, measure, numerical count, or a following conditions are met: combination in the case of a specific (1) The person desiring to use the packaged food does not facilitate value marker without label declaration of its comparisons by consumers and offers presence has submitted to the Commis- opportunity for consumer confusion, he sioner of Food and Drugs full informa- will by regulation designate the appro- tion concerning the proposed usage and priate term or terms to be used for the reasons why he believes label dec- such commodity. laration of the marker should be sub- (b)(1) Statements of weight shall be ject to this exemption; and in terms of avoirdupois pound and (2) The person requesting the exemp- ounce. tion has received from the Commis- (2) Statements of fluid measure shall sioner of Food and Drugs a finding that be in terms of the U.S. gallon of 231 the marker is harmless and that the cubic inches and quart, pint, and fluid exemption has been granted. ounce subdivisions thereof, and shall: (i) In the case of frozen food that is § 501.103 Petitions requesting exemp- sold and consumed in a frozen state, tions from or special requirements express the volume at the frozen tem- for label declaration of ingredients. perature. The Commissioner of Food and (ii) In the case of refrigerated food Drugs, either on his own initiative or that is sold in the refrigerated state, on behalf of any interested person who express the volume at 40 °F (4 °C). has submitted a petition pursuant to (iii) In the case of other foods, ex- part 10 of this chapter may issue a pro- press the volume at 68 °F (20 °C). posal to amend § 501.4 to specify the (3) Statements of dry measure shall manner in which an ingredient(s) shall be in terms of the U.S. bushel of be declared, i.e., by specific or class 2,150.42 cubic inches and peck, dry name, or § 501.100 to exempt an ingre- quart, and dry pint subdivisions there- dient(s) from the requirements for of. label declaration. (c) When the declaration of quantity [41 FR 38619, Sept. 10, 1976, as amended at 42 of contents by numerical count does FR 15675, Mar. 22, 1977] not give adequate information as to the quantity of food in the package, it § 501.105 Declaration of net quantity shall be combined with such statement of contents when exempt. of weight, measure, or size of the indi- (a) The principal display panel of a vidual units of the foods as will provide food in package form shall bear a dec- such information. laration of the net quantity of con- (d) The declaration may contain tents. This shall be expressed in the common or decimal fractions. A com- terms of weight, measure, numerical mon fraction shall be in terms of count, or a combination of numerical halves, quarters, eighths, sixteenths, or count and weight or measure. The thirty-seconds; except that if there ex- statement shall be in terms of fluid ists a firmly established general con- measure if the food is liquid, or in sumer usage and trade custom of em- terms of weight if the food is solid, ploying different common fractions in semisolid, or viscous, or a mixture of the net quantity declaration of a par- solid and liquid; except that such state- ticular commodity, they may be em- ment may be in terms of dry measure ployed. A common fraction shall be re- if the food is a fresh fruit, fresh vege- duced to its lowest terms; a decimal table, or other dry commodity that is fraction shall not be carried out to customarily sold by dry measure. If more than two places. A statement there is a firmly established general that includes small fractions of an consumer usage and trade custom of ounce shall be deemed to permit small- declaring the contents of a liquid by er variations than one which does not weight, or a solid, semisolid, or viscous include such fractions. product by fluid measure, it may be (e) The declaration shall be located used. Whenever the Commissioner de- on the principal display panel of the termines that an existing practice of label, and with respect to packages declaring net quantity of contents by bearing alternate principal panels it

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shall be duplicated on each principal tial of 3 units to 1 unit (no more than display panel. 3 times as high as it is wide). (f) The declaration shall appear as a (2) Letter heights pertain to upper distinct item on the principal display case or capital letters. When upper and panel, shall be separated (by at least a lower case or all lower case letters are 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. 3 the requirement for placement within (3) Not less than ⁄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,

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or pints, as appropriate) with any re- (3) A declaration of 1 quart liquid mainder in terms of fluid ounces or measure shall be expressed as Net 32 fl. common or decimal fractions of the oz. (1 qt.). pint or quart (see examples in para- (4) A declaration of 13⁄4 quarts liquid graphs (m) (3) and (4) of this section). measure shall be expressed as Net con- (2) If the net quantity of contents tents 56 fluid ounces (1 quart 11⁄2 pints) or declaration appears on a random pack- as Net 56 fluid oz. (1 qt. 1 pt. 8 oz.), but age, that is a package which is one of not in terms of quart and ounce such as a lot, shipment, or delivery of packages Net 56 fluid oz. (1 quart 24 ounces). (5) On a random package, declaration of the same consumer commodity with of 3⁄4 pound avoirdupois may be ex- varying weights and with no fixed pressed as Net Wt. .75 lb. weight pattern, it may, when the net (6) A declaration of 21⁄2 gallons liquid weight exceeds 1 pound, be expressed in measure shall be expressed as Net con- terms of pounds and decimal fractions tents 21⁄2 gallons, Net contents 2.5 gallons, of the pound carried out to not more or Net contents 2 gallons 2 quarts and not than two decimal places. When the net as 2 gallons 4 pints. weight does not exceed 1 pound, the (n) For quantities, the following ab- declaration on the random package breviations and none other may be em- may be in decimal fractions of the ployed (periods and plural forms are pound in lieu of ounces (see example in optional): paragraph (m)(5) of this section). weight wt. gallon gal. (3) The declaration may appear in ounce oz. pint pt. more than one line. The term net pound lb. quart qt. weight shall be used when stating the fluid fl. 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 concentrate, etc.) are not regarded as sup- (gallons followed by common or dec- plemental net quantity statements and imal fraction of a gallon or by the next may be located on the principal display smaller whole unit or units (quarts, or panel. quarts and pints)) with any remainder (p) A separate statement of the net in terms of fluid ounces or common or quantity of contents in terms of the decimal fractions of the pint or quart metric system is not regarded as a sup- (see paragraph (m)(6) of this section). plemental statement and an accurate (l) [Reserved] statement of the net quantity of con- (m) Examples: (1) A declaration of 11⁄2 tents in terms of the metric system of pounds weight shall be expressed as Net weight or measure may also appear on Wt. 24 oz. (1 lb. 8 oz.), Net Wt. 24 oz. (11⁄2 the principal display panel or on other lb.), or Net Wt. 24 oz. (1.5 lb.). panels. (2) A declaration of 3⁄4 pound avoirdu- (q) The declaration of net quantity of pois weight shall be expressed as Net contents shall express an accurate Wt. 12 oz. statement of the quantity of contents

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of the package. Reasonable variations § 564.14(b) of this chapter), the mis- caused by loss or gain of moisture dur- labeled food product, including any ing the course of good distribution food product that fails to bear the gen- practice or by unavoidable deviations eral statement of substandard fill spec- in good manufacturing practice will be ified in § 564.14(b) of this chapter, may recognized. Variations from stated be sold by the manufacturer or proc- 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]

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

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contains) ll percent (or %) ll’’ or (1) The presence or absence of a char- ‘‘ll percent (or %) ll’’ with the first acterizing ingredient or component blank filled in with the percentage ex- shall be declared by the words ‘‘con- pressed as a whole number not greater taining (or contains) llll’’ or ‘‘con- 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 fol- tion shall appear following or directly lowing or directly below the word below the part of the common or usual ‘‘containing’’ (or ‘‘contains’’), or di- name of the food required by para- rectly below the part of the common or graphs (a) and (b) of this section, in usual name of the food required by easily legible boldface print or type in paragraph (a) of this section when the distinct contrast to other printed or word ‘‘containing’’ (or ‘‘contains’’) is graphic matter, and in a height not not used, in easily legible boldface less than the larger of the alternatives print or type in distinct contrast to established under paragraph (b)(2) (i) other printed or graphic matter, and in and (ii) of this section. a height not less than the larger of the (d) A common or usual name of a following alternatives: food may be established by common (i) Not less than one-sixteenth inch usage or by establishment of a regula- in height on packages having a prin- tion in this part, in a standard of iden- cipal display panel with an area of 5 tity, or in other regulations in this square inches or less and not less than chapter. one-eighth inch in height if the area of [41 FR 38627, Sept. 10, 1976. Redesignated at the principal display panel is greater 42 FR 14091, Mar. 15, 1977] than 5 square inches; or (ii) Not less than one-half the height § 502.19 Petitions. of the largest type appearing in the (a) The Commissioner of Food and part of the common or usual name of Drugs, either on his own initiative or the food required by paragraph (a) of on behalf of any interested person who this section. has submitted a petition, may publish (c) The common or usual name of a a proposal to issue, amend, or revoke, food shall include a statement of the under this part, a regulation pre- presence or absence of any character- scribing a common or usual name for a izing ingredient(s) or component(s) food, pursuant to part 10 of this chap- and/or the need for the user to add any ter. characterizing ingredient(s) or compo- (b) If the principal display panel of a nent(s) when the presence or absence of food for which a common or usual such ingredient(s) or component(s) in name regulation is established is too the food has a material bearing on small to accommodate all mandatory price or consumer acceptance or when requirements, the Commissioner may the labeling or the appearance of the establish by regulation an acceptable food may otherwise create an erro- alternative, e.g., a smaller type size. A neous impression that such ingre- petition requesting such a regulation, dient(s) or component(s) is present which would amend the applicable reg- when it is not, and consumers may oth- ulation, shall be submitted pursuant to erwise be misled about the presence or part 10 of this chapter. absence of the ingredient(s) or compo- [42 FR 4716, Jan. 25, 1977; 42 FR 10980, Feb. 25, nent(s) in the food. The following re- 1977. Redesignated at 42 FR 14091, Mar. 15, quirements shall apply unless modified 1977, and amended at 42 FR 15675, Mar. 22, by a specific regulation in this part. 1977; 42 FR 24254, May 13, 1977]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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(c) The written food safety plan must mal food for any of the following rea- include: sons: (1) The written hazard analysis as re- (i) The hazard occurs naturally; quired by § 507.33(a)(2); (ii) The hazard may be unintention- (2) The written preventive controls as ally introduced; or required by § 507.34(b); (iii) The hazard may be intentionally (3) The written supply-chain program introduced for purposes of economic as required by subpart E of this part; gain. (4) The written recall plan as re- (c)(1) The hazard analysis must in- quired by § 507.38(a)(1); clude an evaluation of the hazards (5) The written procedures for moni- identified in paragraph (b) of this sec- toring the implementation of the pre- tion to assess the severity of the illness ventive controls as required by or injury to humans or animals if the § 507.40(a); hazard were to occur and the prob- (6) The written corrective action pro- ability that the hazard will occur in cedures as required by § 507.42(a)(1); and the absence of preventive controls. (7) The written verification proce- (2) The hazard evaluation required by dures as required by § 507.49(b). paragraph (c)(1) of this section must in- (d) The food safety plan required by clude an evaluation of environmental this section is a record that is subject pathogens whenever an animal food is to the requirements of subpart F of exposed to the environment prior to this part. packaging and the packaged animal [80 FR 56337, Sept. 17, 2015, as amended at 84 food does not receive a treatment or FR 12491, Apr. 2, 2019] otherwise include a control measure (such as a formulation lethal to the § 507.33 Hazard analysis. pathogen) that would significantly (a)(1) You must conduct a hazard minimize the pathogen. analysis to identify and evaluate, based (d) The hazard evaluation must con- on experience, illness data, scientific sider the effect of the following on the reports, and other information, known safety of the finished animal food for or reasonably foreseeable hazards for the intended animal: each type of animal food manufac- (1) The formulation of the animal tured, processed, packed, or held at food; your facility to determine whether (2) The condition, function, and de- there are any hazards requiring a pre- sign of the facility and equipment; ventive control; and (3) Raw materials and other ingredi- (2) The hazard analysis must be writ- ents; ten regardless of its outcome. (4) Transportation practices; (b) The hazard identification must (5) Manufacturing/processing proce- consider: dures; (1) Known or reasonably foreseeable (6) Packaging activities and labeling hazards that include: activities; (i) Biological hazards, including (7) Storage and distribution; microbiological hazards such as (8) Intended or reasonably foresee- parasites, environmental pathogens, able use; and other pathogens; (9) Sanitation, including employee (ii) Chemical hazards, including radi- hygiene; and ological hazards, substances such as (10) Any other relevant factors such pesticide and drug residues, natural as the temporal (e.g., weather-related) toxins, decomposition, unapproved food nature of some hazards (e.g., levels of or color additives, and nutrient defi- some natural toxins). ciencies or toxicities (such as inad- [80 FR 56337, Sept. 17, 2015, as amended at 81 equate thiamine in cat food, excessive FR 3717, Jan. 22, 2016] vitamin D in dog food, and excessive copper in food for sheep); and § 507.34 Preventive controls. (iii) Physical hazards (such as stones, (a)(1) You must identify and imple- glass, and metal fragments); and ment preventive controls to provide as- (2) Known or reasonably foreseeable surances that any hazards requiring a hazards that may be present in the ani- preventive control will be significantly

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

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

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§ 507.37 Provision of assurances re- management components as appro- quired under § 507.36(a)(2), (3), and priate to ensure the effectiveness of the (4). supply-chain program, taking into ac- A facility that provides a written as- count the nature of the hazard con- surance under § 507.36(a)(2), (3), or (4) trolled before receipt of the raw mate- must act consistently with the assur- rial or other ingredient: ance and document its actions taken to (1) Corrective actions and corrections satisfy the written assurance. in accordance with § 507.42, taking into account the nature of any supplier non- § 507.38 Recall plan. conformance; (a) For animal food with a hazard re- (2) Review of records in accordance quiring a preventive control you must: with § 507.49(a)(4)(ii); and (1) Establish a written recall plan for (3) Reanalysis in accordance with the animal food; and § 507.50. (2) Assign responsibility for per- (c) The recall plan established in forming all procedures in the recall § 507.38 is not subject to the require- plan. ments of paragraph (a) of this section. (b) The written recall plan must include procedures that describe the § 507.40 Monitoring. steps to perform the following actions As appropriate to the nature of the as appropriate to the facility: preventive control and its role in the (1) Directly notify direct consignees facility’s food safety system you must: about the animal food being recalled, (a) Establish and implement written including how to return or dispose of procedures, including the frequency the affected animal food; with which they are to be performed, (2) Notify the public about any haz- for monitoring the preventive controls; ard presented by the animal food when and appropriate to protect human and ani- (b) Monitor the preventive controls mal health; with adequate frequency to provide as- (3) Conduct effectiveness checks to surance that they are consistently per- verify the recall has been carried out; formed. and (4) Appropriately dispose of recalled (c)(1) You must document the moni- animal food, e.g., through reprocessing, toring of preventive controls in accord- reworking, diverting to another use ance with this section in records that that would not present a safety con- are subject to verification in accord- cern, or destroying the animal food. ance with § 507.45(a)(2) and records review in accordance with § 507.49(a)(4)(i); § 507.39 Preventive control manage- (2)(i) Records of refrigeration tem- ment components. perature during storage of animal food (a) Except as provided by paragraphs that requires time/temperature control (b) and (c) of this section, the preven- to significantly minimize or prevent tive controls required under § 507.34 are the growth of, or toxin production by, subject to the following preventive pathogens may be affirmative records control management components as demonstrating temperature is con- appropriate to ensure the effectiveness trolled or exception records dem- of the preventive controls, taking into onstrating loss of temperature control; account the nature of the preventive and control and its role in the facility’s (ii) Exception records may be ade- food safety system: quate in circumstances other than (1) Monitoring in accordance with monitoring of refrigeration tempera- § 507.40; ture. (2) Corrective actions and corrections in accordance with § 507.42; and § 507.42 Corrective actions and correc- (3) Verification in accordance with tions. § 507.45. (a) As appropriate to the nature of (b) The supply-chain program estab- the hazard and the nature of the pre- lished in subpart E of this part is sub- ventive control, except as provided by ject to the following preventive control paragraph (c) of this section:

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

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

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

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

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

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§ 507.62 Issuance of an order to with- (2) Appeal the order within 15 cal- draw a qualified facility exemption. endar days of the date of receipt of the (a) An FDA Division Director in order in accordance with the require- whose division the qualified facility is ments of § 507.69. located (or, in the case of a foreign fa- (e) A statement that a facility may cility, the Director of the Division of request that FDA reinstate an exemp- Compliance in the Center for Veteri- tion that was withdrawn by following nary Medicine), or an FDA official sen- the procedures in § 507.85; ior to either such Director, must ap- (f) The text of section 418(l) of the prove an order to withdraw the exemp- Federal Food, Drug, and Cosmetic Act tion before the order is issued. and of this subpart; (b) Any officer or qualified employee (g) A statement that any informal of FDA may issue an order to withdraw hearing on an appeal of the order must the exemption after it has been ap- be conducted as a regulatory hearing proved in accordance with paragraph under part 16 of this chapter, with cer- (a) of this section. tain exceptions described in § 507.73; (c) FDA must issue an order to with- (h) The mailing address, telephone draw the exemption to the owner, oper- number, email address, fax number, ator, or agent in charge of the facility. and name of the FDA Division Director (d) FDA must issue an order to within whose division the facility is located draw the exemption in writing, signed (or, in the case of a foreign facility, the and dated by the officer or qualified same information for the Director of employee of FDA who is issuing the the Division of Compliance in the Cen- order. ter for Veterinary Medicine); and [80 FR 56337, Sept. 17, 2015, as amended at 85 (i) The name and the title of the FDA FR 16554, Mar. 24, 2020] representative who approved the order. § 507.65 Contents of an order to with- [80 FR 56337, Sept. 17, 2015, as amended at 81 draw a qualified facility exemption. FR 3718, Jan. 22, 2016; 85 FR 16554, Mar. 24, 2020] An order to withdraw a qualified facility exemption under § 507.5(d) must § 507.67 Compliance with, or appeal of, include the following information: an order to withdraw a qualified fa- (a) The date of the order; cility exemption. (b) The name, address, and location of the qualified facility; (a) If you receive an order under (c) A brief, general statement of the § 507.65 to withdraw a qualified facility reasons for the order, including infor- exemption, you must either: mation relevant to one or both of the (1) Comply with applicable require- following circumstances that leads ments of this part within 120 calendar FDA to issue the order: days of the date of receipt of the order, (1) An active investigation of a or within a reasonable timeframe, foodborne illness outbreak that is di- agreed to by FDA, based on a written rectly linked to the facility; or justification, submitted to FDA, for a (2) Conditions or conduct associated timeframe that exceeds 120 calendar with a qualified facility that are mate- days from the date of receipt of the rial to the safety of the animal food order; or manufactured, processed, packed, or (2) Appeal the order within 15 cal- held at such facility. endar days of the date of receipt of the (d) A statement that the facility order in accordance with the require- must either: ments of § 507.69. (1) Comply with subparts C and E of (b) Submission of an appeal, includ- this part on the date that is 120 cal- ing submission of a request for an in- endar days after the date of receipt of formal hearing, will not operate to the order or within a reasonable time- delay or stay any administrative ac- frame, agreed to by FDA, based on a tion, including enforcement action by written justification, submitted to FDA, unless the Commissioner of Food FDA, for a timeframe that exceeds 120 and Drugs, as a matter of discretion, calendar days from the date of receipt determines that delay or a stay is in of the order; or the public interest.

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(c) If you appeal the order, and FDA tion will be given to you explaining the confirms the order: reason for the denial. (1) You must comply with applicable requirements of this part within 120 § 507.73 Requirements applicable to an calendar days of the date of receipt of informal hearing. the order, or within a reasonable time- If you request an informal hearing, frame, agreed to by FDA, based on a and FDA grants the request: written justification, submitted to (a) The hearing will be held within 15 FDA, for a timeframe that exceeds 120 calendar days after the date the appeal calendar days from the date of receipt is filed or, if applicable, within a time- of the order; and frame agreed upon in writing by you (2) You are no longer subject to the and FDA. requirements in § 507.7. (b) The presiding officer may require that a hearing conducted under this § 507.69 Procedure for submitting an subpart be completed within 1 calendar appeal. day, as appropriate. (a) To appeal an order to withdraw a (c) FDA must conduct the hearing in qualified facility exemption, you must: accordance with part 16 of this chapter, (1) Submit the appeal in writing to except that: the FDA Division Director in whose di- (1) The order withdrawing an exemp- vision the facility is located (or, in the tion under §§ 507.62 and 507.65, rather case of a foreign facility, the Director than the notice under § 16.22(a) of this of the Division of Compliance in the chapter, provides notice of opportunity Center for Veterinary Medicine), at the for a hearing under this section and is mailing address, email address, or fax part of the administrative record of the number identified in the order within regulatory hearing under § 16.80(a) of 15 calendar days of the date of receipt this chapter. of confirmation of the order; and (2) A request for a hearing under this (2) Respond with particularity to the subpart must be addressed to the FDA facts and issues contained in the order, Division Director (or, in the case of a including any supporting documenta- foreign facility, the Director of the Di- tion upon which you rely. vision of Compliance in the Center for (b) In a written appeal of the order Veterinary Medicine) as provided in withdrawing an exemption provided the order withdrawing an exemption. under § 507.5(d), you may include a (3) Section 507.75, rather than written request for an informal hearing § 16.42(a) of this chapter, describes the as provided in § 507.71. FDA employees who preside at hear- [80 FR 56337, Sept. 17, 2015, as amended at 81 ings under this subpart. FR 3718, Jan. 22, 2016; 85 FR 16554, Mar. 24, (4) Section 16.60(e) and (f) of this 2020] chapter does not apply to a hearing under this subpart. The presiding offi- § 507.71 Procedure for requesting an cer must prepare a written report of informal hearing. the hearing. All written material pre- (a) If you appeal the order, you: sented at the hearing will be attached (1) May request an informal hearing; to the report. The presiding officer and must include as part of the report of (2) Must submit any request for an the hearing a finding on the credibility informal hearing together with your of witnesses (other than expert wit- written appeal submitted in accordance nesses) whenever credibility is a mate- with § 507.69 within 15 calendar days of rial issue, and must include a proposed the date of receipt of the order. decision, with a statement of reasons. (b) A request for an informal hearing The hearing participant may review may be denied, in whole or in part, if and comment on the presiding officer’s the presiding officer determines that report within 2 calendar days of no genuine and substantial issue of ma- issuance of the report. The presiding terial fact has been raised by the mate- officer will then issue the final deci- rial submitted. If the presiding officer sion. determines that a hearing is not justi- (5) Section 16.80(a)(4) of this chapter fied, written notice of the determina- does not apply to a regulatory hearing

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under this subpart. The presiding offi- ments on the report of the hearing cer’s report of the hearing and any under § 507.73(c)(4), and must issue a comments on the report by the hearing final decision within 10 calendar days participant under paragraph (c)(4) of after the hearing is held; or this section are part of the administra- (2) If FDA denies the request for a tive record. hearing, the presiding officer must (6) No party shall have the right, issue a final decision on the appeal under § 16.119 of this chapter to petition confirming or revoking the withdrawal the Commissioner of Food and Drugs within 10 calendar days after the date for reconsideration or a stay of the pre- the appeal is filed. siding officer’s final decision. (7) If FDA grants a request for an in- § 507.80 Revocation of an order to formal hearing on an appeal of an order withdraw a qualified facility ex- withdrawing an exemption, the hearing emption. must be conducted as a regulatory An order to withdraw a qualified fa- hearing under a regulation in accord- cility exemption is revoked if: ance with part 16 of this chapter, ex- (a) You appeal the order and request cept that § 16.95(b) does not apply to a an informal hearing, FDA grants the hearing under this subpart. With re- request for an informal hearing, and spect to a regulatory hearing under the presiding officer does not confirm this subpart, the administrative record the order within the 10 calendar days of the hearing specified in §§ 16.80(a)(1) after the hearing, or issues a decision through (3), and (a)(5), of this chapter, revoking the order within that time; or and 507.73(c)(5) constitutes the exclu- (b) You appeal the order and request sive record for the presiding officer’s an informal hearing, FDA denies the final decision. For purposes of judicial request for an informal hearing, and review under § 10.45 of this chapter, the FDA does not confirm the order within record of the administrative pro- the 10 calendar days after the appeal is ceeding consists of the record of the filed, or issues a decision revoking the hearing and the presiding officer’s final order within that time; or decision. (c) You appeal the order without requesting an informal hearing, and FDA [80 FR 56337, Sept. 17, 2015, as amended at 85 does not confirm the order within the FR 16554, Mar. 24, 2020] 10 calendar days after the appeal is § 507.75 Presiding officer for an appeal filed, or issues a decision revoking the and for an informal hearing. order within that time. The presiding officer for an appeal, § 507.83 Final agency action. and for an informal hearing, must be an Office of Regulatory Affairs Pro- Confirmation of a withdrawal order gram Director or another FDA official by the presiding officer is considered a senior to an FDA Division Director. final agency action for purposes of 5 U.S.C. 702. [85 FR 16555, Mar. 24, 2020] § 507.85 Reinstatement of a qualified § 507.77 Timeframe for issuing a deci- facility exemption that was with- sion on an appeal. drawn. (a) If you appeal the order without (a) If the FDA Division Director in requesting a hearing, the presiding offi- whose division your facility is located cer must issue a written report that in- (or, in the case of a foreign facility, the cludes a final decision confirming or Director of the Division of Compliance revoking the withdrawal by the 10th in the Center for Veterinary Medicine) calendar day after the appeal is filed. determines that a facility has ade- (b) If you appeal the order and re- quately resolved any problems with the quest an informal hearing: conditions and conduct that are mate- (1) If FDA grants the request for a rial to the safety of the animal food hearing and the hearing is held, the manufactured, processed, packed, or presiding officer must provide a 2 cal- held at the facility and that continued endar day opportunity for the hearing withdrawal of the exemption is not participants to review and submit com- necessary to protect public (human and

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animal) health and prevent or mitigate Subpart E—Supply-Chain Program a foodborne illness outbreak, the FDA Division Director in whose division § 507.105 Requirement to establish and your facility is located (or, in the case implement a supply-chain program. of a foreign facility, the Director of the (a)(1) Except as provided by para- Division of Compliance in the Center graphs (a)(2) and (3) of this section, the for Veterinary Medicine) will, on his or receiving facility must establish and her own initiative or on the request of implement a risk-based supply-chain a facility, reinstate the exemption. program for those raw materials and (b) You may ask FDA to reinstate an other ingredients for which the receiv- exemption that has been withdrawn ing facility has identified a hazard re- under the procedures of this subpart as quiring a supply-chain-applied control. follows: (2) A receiving facility that is an im- (1) Submit a request, in writing, to porter, is in compliance with the for- the FDA Division Director in whose di- eign supplier verification requirements vision your facility is located (or, in under part 1, subpart L of this chapter, the case of a foreign facility, the Direc- and has documentation of verification tor of the Division of Compliance in activities conducted under § 1.506(e) of the Center for Veterinary Medicine); this chapter (which provides assurance that the hazards requiring a supply- and chain-applied control for the raw mate- (2) Present data and information to rial or other ingredient have been sig- demonstrate that you have adequately nificantly minimized or prevented) resolved any problems with the condi- need not conduct supplier verification tions and conduct that are material to activities for that raw material or the safety of the animal food manufac- other ingredient. tured, processed, packed, or held at (3) The requirements in this subpart your facility, such that continued do not apply to animal food that is sup- withdrawal of the exemption is not plied for research or evaluation use, necessary to protect public (human and provided that such animal food: animal) health and prevent or mitigate (i) Is not intended for retail sale and a foodborne illness outbreak. is not sold or distributed to the public; (c) If your exemption was withdrawn (ii) Is labeled with the statement under § 507.60(a)(1) and FDA later deter- ‘‘Animal food for research or evalua- mines, after finishing the active inves- tion use’’; tigation of a foodborne illness out- (iii) Is supplied in a small quantity break, that the outbreak is not di- that is consistent with a research, rectly linked to your facility, FDA will analysis, or quality assurance purpose, reinstate your exemption under the animal food is used only for this § 507.5(d), and FDA will notify you in purpose, and any unused quantity is writing that your exempt status has properly disposed of; and been reinstated. (iv) Is accompanied with documents, (d) If your exemption was withdrawn in accordance with the practice of the under both § 507.60(a)(1) and (2) and trade, stating that the animal food will FDA later determines, after finishing be used for research or evaluation pur- the active investigation of a foodborne poses and cannot be sold or distributed illness outbreak, that the outbreak is to the public. not directly linked to your facility, (b) The supply-chain program must FDA will inform you of this finding be written. and you may ask FDA to reinstate (c) When a supply-chain-applied con- your exemption under § 507.5(d) in ac- trol is applied by an entity other than cordance with the requirements of the receiving facility’s supplier (e.g., when a non-supplier applies controls to paragraph (b) of this section. certain produce (i.e., produce covered [80 FR 56337, Sept. 17, 2015, as amended at 85 by part 112 of this chapter), because FR 16555, Mar. 24, 2020] growing, harvesting, and packing activities are under different management), the receiving facility must:

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(1) Verify the supply-chain-applied propriate supplier verification activi- control; or ties and the frequency with which they (2) Obtain documentation of an ap- are conducted, the following must be propriate verification activity from an- considered: other entity, review and assess the en- (i) The hazard analysis of the animal tity’s applicable documentation, and food, including the nature of the haz- document that review and assessment. ard controlled before receipt of the raw EFFECTIVE DATE NOTE: At 80 FR 56337, material or other ingredient, applica- Sept. 17, 2015, part 507 was added, effective ble to the raw material and other in- Nov. 16, 2015, with the exception of paragraph gredients; (a)(2) in § 507.105, which is not yet effective. (ii) The entity or entities that will be applying controls for the hazards re- § 507.110 General requirements appli- quiring a supply-chain-applied control; cable to a supply-chain program. (iii) Supplier performance, including: (a) The supply-chain program must (A) The supplier’s procedures, proc- include: esses, and practices related to the safe- (1) Using approved suppliers as re- ty of the raw material and other ingre- quired by § 507.120; dients; (2) Determining appropriate supplier (B) Applicable FDA food safety regu- verification activities (including deter- lations and information relevant to the mining the frequency of conducting the supplier’s compliance with those regu- activity) as required by § 507.125; lations, including an FDA warning let- (3) Conducting supplier verification ter or import alert relating to the safe- activities as required by §§ 507.130 and ty of animal food and other FDA com- 507.135; pliance actions related to animal food (4) Documenting supplier verification safety (or, when applicable, relevant activities as required by § 507.175; and laws and regulations of a country (5) When applicable, verifying a sup- whose food safety system FDA has offi- ply-chain-applied control applied by an cially recognized as comparable or has entity other than the receiving facili- determined to be equivalent to that of ty’s supplier and documenting that the United States, and information rel- verification as required by § 507.175, or evant to the supplier’s compliance with obtaining documentation of an appro- those laws and regulations); and priate verification activity from another entity, reviewing and assessing (C) The supplier’s food safety history that documentation, and documenting relevant to the raw materials or other the review and assessment as required ingredients that the receiving facility by § 507.175. receives from the supplier, including (b) The following are appropriate sup- available information about results plier verification activities for raw ma- from testing raw materials or other in- terials and other ingredients: gredients for hazards, audit results re- (1) Onsite audits; lating to the safety of the animal food, (2) Sampling and testing of the raw and responsiveness of the supplier in material or other ingredient; correcting problems; and (3) Review of the supplier’s relevant (iv) Any other factors as appropriate food safety records; and and necessary, such as storage and (4) Other appropriate supplier transportation practices. verification activities based on sup- (2) Considering supplier performance plier performance and the risk associ- can be limited to the supplier’s compli- ated with the raw material or other in- ance history as required by paragraph gredient. (d)(1)(iii)(B) of this section, if the sup- (c) The supply-chain program must plier is: provide assurance that a hazard requir- (i) A qualified facility as defined by ing a supply-chain-applied control has § 507.3; been significantly minimized or pre- (ii) A farm that grows produce and is vented. not a covered farm under part 112 of (d)(1) Except as provided by para- this chapter in accordance with graph (d)(2) of this section, in approv- § 112.4(a), or in accordance with ing suppliers and determining the ap- §§ 112.4(b) and 112.5; or

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(iii) A shell egg producer that is not mentation, and documents that review subject to the requirements of part 118 and assessment. of this chapter because it has less than (b) For the purposes of this subpart, a 3,000 laying hens. receiving facility may not accept any (e) If the owner, operator, or agent in of the following as a supplier charge of a receiving facility deter- verification activity: mines through auditing, verification (1) A determination by its supplier of testing, document review, relevant the appropriate supplier verification consumer, customer, or other com- activities for that supplier; plaints, or otherwise that the supplier (2) An audit conducted by its sup- is not controlling hazards that the re- plier; ceiving facility has identified as re- (3) A review by its supplier of that quiring a supply-chain-applied control, supplier’s own relevant food safety the receiving facility must take and records; or document prompt action in accordance (4) The conduct by its supplier of with § 507.42 to ensure that raw mate- other appropriate supplier verification rials or other ingredients from the sup- activities for that supplier within the plier do not cause animal food that is meaning of § 507.110(b)(4). manufactured or processed by the re- (c) The requirements of this section ceiving facility to be adulterated under do not prohibit a receiving facility section 402 of the Federal Food, Drug, from relying on an audit provided by and Cosmetic Act. its supplier when the audit of the supplier was conducted by a third-party § 507.115 Responsibilities of the receiv- qualified auditor in accordance with ing facility. §§ 507.130(f) and 507.135. (a)(1) The receiving facility must approve suppliers. § 507.120 Using approved suppliers. (2) Except as provided by paragraphs (a) The receiving facility must ap- (a)(3) and (4) of this section, the receiv- prove suppliers in accordance with the ing facility must determine and con- requirements of § 507.110(d), and docu- duct appropriate supplier verification ment that approval, before receiving activities, and satisfy all documenta- raw materials and other ingredients re- tion requirements of this subpart. ceived from those suppliers; (3) An entity other than the receiving (b)(1) Written procedures for receiv- facility may do any of the following, ing raw materials and other ingredi- provided that the receiving facility re- ents must be established and followed; views and assesses the entity’s applica- (2) The written procedures for receiv- ble documentation, and documents ing raw materials and other ingredi- that review and assessment: ents must ensure that raw materials (i) Establish written procedures for and other ingredients are received only receiving raw materials and other in- from approved suppliers (or, when nec- gredients by the entity; essary and appropriate, on a temporary (ii) Document that written proce- basis from unapproved suppliers whose dures for receiving raw materials and raw materials or other ingredients are other ingredients are being followed by subjected to adequate verification ac- the entity; and tivities before acceptance for use); and (iii) Determine, conduct, or both de- (3) Use of the written procedures for termine and conduct, the appropriate receiving raw materials and other in- supplier verification activities, with gredients must be documented. appropriate documentation. (4) The supplier may conduct and § 507.125 Determining appropriate document sampling and testing of raw supplier verification activities (in- materials and other ingredients, for cluding determining the frequency the hazard controlled by the supplier, of conducting the activity). as a supplier verification activity for a Appropriate supplier verification ac- particular lot of product and provide tivities (including the frequency of such documentation to the receiving conducting the activity) must be deter- facility, provided that the receiving fa- mined in accordance with the require- cility reviews and assesses that documents of § 507.110(d).

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§ 507.130 Conducting supplier States). The written assurance must verification activities for raw mate- include either: rials and other ingredients. (i) A brief description of the preven- (a) Except as provided by paragraphs tive controls that the supplier is imple- (c), (d), or (e) of this section, one or menting to control the applicable haz- more of the supplier verification ac- ard in the animal food; or tivities specified in § 507.110(b), as de- (ii) A statement that the facility is termined under § 507.110(d), must be in compliance with State, local, coun- conducted for each supplier before ty, tribal, or other applicable non-Fed- using the raw material or other ingre- eral food safety laws, including rel- dient from that supplier and periodi- evant laws and regulations of foreign cally thereafter. countries. (b)(1) Except as provided by para- (d) If a supplier is a farm that grows graph (b)(2) of this section, when a haz- produce and is not a covered farm ard in a raw material or other ingre- under part 112 of this chapter in ac- dient will be controlled by the supplier cordance with § 112.4(a), or in accord- and is one for which there is a reason- ance with §§ 112.4(b) and 112.5, the re- able probability that exposure to the ceiving facility does not need to com- hazard will result in serious adverse ply with paragraphs (a) and (b) of this health consequences or death to hu- section for produce that the receiving mans or animals: facility receives from the farm as a raw (i) The appropriate supplier material or other ingredient if the re- verification activity is an onsite audit ceiving facility: of the supplier; and (1) Obtains written assurance that (ii) The audit must be conducted be- the raw material or other ingredient fore using the raw material or other in- provided by the supplier is not subject gredient from the supplier and at least to part 112 of this chapter in accord- annually thereafter. ance with § 112.4(a), or in accordance (2) The requirements of paragraph with §§ 112.4(b) and 112.5: (b)(1) of this section do not apply if (i) Before first approving the supplier there is a written determination that for an applicable calendar year; and other verification activities and/or less (ii) On an annual basis thereafter, by frequent onsite auditing of the supplier December 31 of each calendar year, for provide adequate assurance that the the following calendar year; and hazards are controlled. (2) Obtains written assurance, at (c) If a supplier is a qualified facility least every 2 years, that the farm ac- as defined by § 507.3, the receiving facil- knowledges that its food is subject to ity does not need to comply with para- section 402 of the Federal Food, Drug, graphs (a) and (b) of this section if the and Cosmetic Act (or, when applicable, receiving facility: that its food is subject to relevant laws (1) Obtains written assurance that and regulations of a country whose the supplier is a qualified facility as food safety system FDA has officially defined by § 507.3: recognized as comparable or has deter- (i) Before first approving the supplier mined to be equivalent to that of the for an applicable calendar year; and United States). (ii) On an annual basis thereafter, by (e) If a supplier is a shell egg pro- December 31 of each calendar year, for ducer that is not subject to the re- the following calendar year; and quirements of part 118 of this chapter (2) Obtains written assurance, at because it has less than 3,000 laying least every 2 years, that the supplier is hens, the receiving facility does not producing the raw material or other in- need to comply with paragraphs (a) and gredient in compliance with applicable (b) of this section if the receiving facil- FDA food safety regulations (or, when ity: applicable, relevant laws and regula- (1) Obtains written assurance that tions of a country whose food safety the shell eggs produced by the supplier system FDA has officially recognized are not subject to part 118 because the as comparable or has determined to be shell egg producer has less than 3,000 equivalent to that of the United laying hens:

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(i) Before first approving the supplier (ii) For a foreign supplier, the writ- for an applicable calendar year; and ten results of an inspection by FDA or (ii) On an annual basis thereafter, by the food safety authority of a country December 31 of each calendar year, for whose food safety system FDA has offi- the following calendar year; and cially recognized as comparable or has (2) Obtains written assurance, at determined to be equivalent to that of least every 2 years, that the shell egg the United States. producer acknowledges that its food is (2) For inspections conducted by the subject to section 402 of the Federal food safety authority of a country Food, Drug, and Cosmetic Act (or, whose food safety system FDA has offi- when applicable, that its food is sub- cially recognized as comparable or de- ject to relevant laws and regulations of termined to be equivalent, the animal a country whose food safety system food that is the subject of the onsite FDA has officially recognized as com- audit must be within the scope of the parable or has determined to be equivalent to that of the United States). official recognition or equivalence de- (f) There must not be any financial termination, and the foreign supplier conflicts of interest that influence the must be in, and under the regulatory results of the verification activities oversight of, such country. listed in § 507.110(b) and payment must (d) If the onsite audit is solely con- not be related to the results of the ac- ducted to meet the requirements of tivity. this subpart by an audit agent of a certification body that is accredited in ac- [80 FR 56337, Sept. 17, 2015, as amended at 84 cordance with regulations in part 1, FR 12491, Apr. 2, 2019] subpart M of this chapter, the audit is § 507.135 Onsite audit. not subject to the requirements in (a) An onsite audit of a supplier must those regulations. be performed by a qualified auditor. EFFECTIVE DATE NOTE: At 80 FR 56337, (b) If the raw material or other ingre- Sept. 17, 2015, part 507 was added, effective dient at the supplier is subject to one Nov. 16, 2015, with the exception of paragraph or more FDA food safety regulations, (d) in § 507.135, which is not yet effective. an onsite audit must consider such regulations and include a review of the § 507.175 Records documenting the supplier’s written plan (e.g., Hazard supply-chain program. Analysis and Critical Control Point (a) The records documenting the sup- (HACCP) plan or other food safety ply-chain program are subject to the plan), if any, and its implementation, requirements of subpart F of this part. for the hazard being controlled (or, (b) The receiving facility must re- when applicable, an onsite audit may view the records listed in paragraph (c) consider relevant laws and regulations of this section in accordance with of a country whose food safety system § 507.49(a)(4). FDA has officially recognized as com- (c) The receiving facility must docu- parable or has determined to be equiva- ment the following in records as appli- lent to that of the United States). cable to its supply-chain program: (c)(1) The following may be sub- (1) The written supply-chain pro- stituted for an onsite audit, provided that the inspection was conducted gram; within 1 year of the date that the on- (2) Documentation that a receiving site audit would have been required to facility that is an importer is in com- be conducted: pliance with the foreign supplier (i) The written results of an appro- verification program requirements priate inspection of the supplier for under part 1, subpart L of this chapter, compliance with applicable FDA food including documentation of safety regulations by FDA, by rep- verification activities conducted under resentatives of other Federal Agencies § 1.506(e) of this chapter; (such as the United States Department (3) Documentation of the approval of of Agriculture), or by representatives a supplier; of State, local, tribal, or territorial (4) Written procedures for receiving agencies; or raw materials and other ingredients;

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(5) Documentation demonstrating use the risk associated with the raw mate- of the written procedures for receiving rial or other ingredient; raw materials and other ingredients; (11) Documentation of any deter- (6) Documentation of the determina- mination that verification activities tion of the appropriate supplier other than an onsite audit, and/or less verification activities for raw mate- frequent onsite auditing of a supplier, rials and other ingredients; provide adequate assurance that the (7) Documentation of the conduct of hazards are controlled when a hazard an onsite audit. This documentation in a raw material or other ingredient must include: will be controlled by the supplier and is (i) The name of the supplier subject one for which there is a reasonable to the onsite audit; probability that exposure to the hazard (ii) Documentation of audit proce- will result in serious adverse health dures; consequences or death to humans or (iii) The dates the audit was con- animals; ducted; (12) The following documentation of (iv) The conclusions of the audit; an alternative verification activity for (v) Corrective actions taken in re- a supplier that is a qualified facility: sponse to significant deficiencies iden- (i) The written assurance that the tified during the audit; and supplier is a qualified facility as de- (vi) Documentation that the audit fined by § 507.3; and was conducted by a qualified auditor; (ii) The written assurance that the (8) Documentation of sampling and supplier is producing the raw material testing conducted as a supplier or other ingredient in compliance with verification activity. This documenta- applicable FDA food safety regulations tion must include: (or, when applicable, relevant laws and regulations of a country whose food (i) Identification of the raw material safety system FDA has officially recog- or other ingredient tested (including nized as comparable or has determined lot number, as appropriate) and the to be equivalent to that of the United number of samples tested; States); (ii) Identification of the test(s) con- (13) The following documentation of ducted, including the analytical meth- an alternative verification activity for od(s) used; a supplier that is a farm that supplies (iii) The date(s) on which the test(s) a raw material or other ingredient and were conducted and the date of the re- is not a covered farm under part 112 of port; this chapter: (iv) The results of the testing; (i) The written assurance that sup- (v) Corrective actions taken in re- plier is not a covered farm under part sponse to detection of hazards; and 112 of this chapter in accordance with (vi) Information identifying the lab- § 112.4(a), or in accordance with oratory conducting the testing; §§ 112.4(b) and 112.5; and (9) Documentation of the review of (ii) The written assurance that the the supplier’s relevant food safety farm acknowledges that its food is sub- records. This documentation must inject to section 402 of the Federal Food, clude: Drug, and Cosmetic Act (or, when ap- (i) The name of the supplier whose plicable, that its food is subject to rel- records were reviewed; evant laws and regulations of a coun- (ii) The date(s) of review; try whose food safety system FDA has (iii) The general nature of the records officially recognized as comparable or reviewed; has determined to be equivalent to (iv) The conclusions of the review; that of the United States); and (14) The following documentation of (v) Corrective actions taken in re- an alternative verification activity for sponse to significant deficiencies iden- a supplier that is a shell egg producer tified during the review; that is not subject to the requirements (10) Documentation of other appro- established in part 118 of this chapter priate supplier verification activities because it has less than 3,000 laying based on the supplier performance and hens:

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(i) The written assurance that the accordance with §§ 507.130(f) and 507.135; shell eggs provided by the supplier are and not subject to part 118 of this chapter (v) Applicable documentation, from because the supplier has less than 3,000 an entity other than the receiving fa- laying hens; and cility, of verification activities when a (ii) The written assurance that the supply-chain-applied control is applied shell egg producer acknowledges that by an entity other than the receiving its food is subject to section 402 of the facility’s supplier. Federal Food, Drug, and Cosmetic Act EFFECTIVE DATE NOTE: At 80 FR 56337, (or, when applicable, that its food is Sept. 17, 2015, part 507 was added, effective subject to relevant laws and regula- Nov. 16, 2015, with the exception of paragraph tions of a country whose safety system (c)(2) in § 507.175, which is not yet effective. FDA has officially recognized as comparable or has determined to be equiva- Subpart F—Requirements Apply- lent to that of the United States); (15) The written results of an appro- ing to Records That Must Be priate inspection of the supplier for Established and Maintained compliance with applicable FDA food § 507.200 Records subject to the re- safety regulations by FDA, by rep- quirements of this subpart. resentatives of other Federal Agencies (such as the United States Department (a) Except as provided by paragraphs of Agriculture), or by representatives (d) and (e) of this section, all records from State, local, tribal, or territorial required by this part are subject to all agencies, or the food safety authority requirements of this subpart. of another country when the results of (b) Records obtained by FDA in ac- such an inspection is substituted for an cordance with this part are subject to onsite audit; the disclosure requirements under part (16) Documentation of actions taken 20 of this chapter. with respect to supplier non-conform- (c) All records required by this part ance; must be made promptly available to a (17) Documentation of verification of duly authorized representative of the a supply-chain-applied control applied Secretary of Health and Human Serv- by an entity other than the receiving ices for official review and copying facility’s supplier; and upon oral or written request. (18) When applicable, documentation (d) The requirements of § 507.206 apply of the receiving facility’s review and only to the written food safety plan. assessment of: (e) The requirements of § 507.202(a)(2), (i) Applicable documentation from an (4), and (5) and (b) do not apply to the entity other than the receiving facility records required by § 507.7. that written procedures for receiving raw materials and other ingredients § 507.202 General requirements apply- are being followed; ing to records. (ii) Applicable documentation, from (a) Records must: an entity other than the receiving fa- (1) Be kept as original records, true cility, of the determination of the ap- copies (such as photocopies, pictures, propriate supplier verification activi- scanned copies, microfilm, microfiche, ties for raw materials and other ingre- or other accurate reproductions of the dients; original records), or electronic records; (iii) Applicable documentation, from (2) Contain the actual values and ob- an entity other than the receiving fa- servations obtained during monitoring cility, of conducting the appropriate and as appropriate, during verification supplier verification activities for raw activities; materials and other ingredients; (3) Be accurate, indelible, and legible; (iv) Applicable documentation, from (4) Be created concurrently with per- its supplier, of: formance of the activity documented; (A) The results of sampling and test- and ing conducted by the supplier; or (5) Be as detailed as necessary to pro- (B) The results of an audit conducted vide history of work performed. by a third-party qualified auditor in (b) All records must include:

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(1) Information adequate to identify ty plan must remain onsite. Electronic the plant or facility (e.g., the name, records are considered to be onsite if and when necessary, the location of the they are accessible from an onsite loca- plant or facility); tion. (2) The date and, when appropriate, (d) If the plant or facility is closed the time of the activity documented; for a prolonged period, the food safety (3) The signature or initials of the plan may be transferred to some other person performing the activity; and reasonably accessible location but (4) Where appropriate, the identity of must be returned to the plant or facil- the product and the lot code, if any. ity within 24 hours for official review (c) Records that are established or upon request. maintained to satisfy the requirements of this part and that meet the defini- § 507.212 Use of existing records. tion of electronic records in § 11.3(b)(6) (a) Existing records (e.g., records that of this chapter are exempt from the re- are kept to comply with other Federal, quirements of part 11 of this chapter. State, or local regulations, or for any Records that satisfy the requirements other reason) do not need to be dupli- of this part, but that also are required cated if they contain all of the required under other applicable statutory provi- information and satisfy the require- sions or regulations, remain subject to ments of this subpart. Existing records part 11 of this chapter. may be supplemented as necessary to include all of the required information § 507.206 Additional requirements ap- and satisfy the requirements of this plying to the food safety plan. subpart. The owner, operator, or agent in (b) The information required by this charge of the facility must sign and part does not need to be kept in one set date the food safety plan upon initial of records. If existing records contain completion and upon any modification. some of the required information, any new information required by this part § 507.208 Requirements for record re- may be kept either separately or com- tention. bined with the existing records. (a)(1) All records required by this part must be retained at the plant or § 507.215 Special requirements appli- facility for at least 2 years after the cable to a written assurance. date they were prepared. (a) Any written assurance required (2) Records that a facility relies on by this part must contain the following during the 3-year period preceding the elements: applicable calendar year to support its (1) Effective date; status as a qualified facility must be (2) Printed names and signatures of retained at the facility as long as nec- authorized officials; essary to support the status of a facil- (3) The applicable assurance under: ity as a qualified facility during the (i) § 507.36(a)(2); applicable calendar year. (ii) § 507.36(a)(3); (b) Records that relate to the general (iii) § 507.36(a)(4); adequacy of the equipment or processes (iv) § 507.130(c)(2); being used by a facility, including the (v) § 507.130(d)(2); or results of scientific studies and evalua- (vi) § 507.130(e)(2). tions, must be retained by the facility (b) A written assurance required for at least 2 years after their use is under § 507.36(a)(2), (3) or (4) must in- discontinued (e.g., because the facility clude: has updated the written food safety (1) Acknowledgement that the facil- plan (§ 507.31) or records that document ity that provides the written assurance validation of the written food safety assumes legal responsibility to act con- plan (§ 507.45(b))). sistently with the assurance and docu- (c) Except for the food safety plan, ment its actions taken to satisfy the offsite storage of records is permitted written assurance; and if such records can be retrieved and (2) Provision that if the assurance is provided onsite within 24 hours of re- terminated in writing by either entity, quest for official review. The food safe- responsibility for compliance with the

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

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under section 402(a)(1) of the act. These food may be established when the fol- regulations do not constitute a com- lowing criteria are met: plete list of such foods. (1) The substance cannot be avoided by good manufacturing practice. [42 FR 52821, Sept. 30, 1977, as amended at 55 FR 20786, May 21, 1990] (2) The tolerance established is sufficient for the protection of the public § 509.5 Petitions. health, taking into account the extent of which the presence of the substance The Commissioner of Food and cannot be avoided and the other ways Drugs, either on his own initiative or in which the consumer may be affected on behalf of any interested person who by the same or related poisonous or has submitted a petition, may issue a deleterious substances. proposal to establish, revoke, or amend (3) No technological or other changes a regulation under this part. Any such are foreseeable in the near future that petition shall include an adequate fac- might affect the appropriateness of the tual basis to support the petition, shall tolerance established. Examples of be in the form set forth in § 10.30 of this changes that might affect the appro- chapter, and will be published in the priateness of the tolerance include an- FEDERAL REGISTER for comment if it ticipated improvements in good manu- contains reasonable grounds for the facturing practice that would change proposed regulation. the extent to which use of the sub- [42 FR 52821, Sept. 30, 1977, as amended at 54 stance is unavoidable and anticipated FR 18280, Apr. 28, 1989] studies expected to provide significant new toxicological or use data. § 509.6 Added poisonous or deleterious (c) A regulatory limit for an added substances. poisonous or deleterious substance in (a) Use of an added poisonous or dele- any food may be established when each terious substance, other than a pes- of the following criteria is met: ticide chemical, that is also a food ad- (1) The substance cannot be avoided ditive will be controlled by a regula- by current good manufacturing prac- tion issued under section 409 of the act tices. when possible. When such a use cannot (2) There is no tolerance established be approved under the criteria of sec- for the substance in the particular food tion 409 of the act, or when the added under sections 406, 408, or 409 of the act. poisonous or deleterious substance is (3) There is insufficient information not a food additive, a tolerance, regu- by which a tolerance may be estab- latory limit, or action level may be es- lished for the substance under section tablished pursuant to the criteria in 406 of the act or technological changes paragraphs (b), (c), or (d) of this sec- appear reasonably possible that may tion. Residues resulting from the use of affect the appropriateness of a toler- an added poisonous or deleterious sub- ance. The regulatory limit established stance that is also a pesticide chemical represents the level at which food is will ordinarily be controlled by a toler- adulterated within the meaning of sec- ance established in a regulation issued tion 402(a)(1) of the act. under sections 406, 408, or 409 of the act (d) An action level for an added poi- by the U.S. Environmental Protection sonous or deleterious substance in any Agency (EPA). When such a regulation food may be established when the cri- has not been issued, an action level for teria in paragraph (b) of this section an added poisonous or deleterious sub- are met, except that technological or stance that is also a pesticide chemical other changes that might affect the ap- may be established by the Food and propriateness of the tolerance are fore- Drug Administration. The Food and seeable in the near future. An action Drug Administration will request EPA level for an added poisonous or delete- to recommend such an action level pur- rious substance in any food may be es- suant to the criteria established in tablished at a level at which the Food paragraph (d) of this section. and Drug Administration may regard (b) A tolerance for an added poi- the food as adulterated within the sonous or deleterious substance in any meaning of section 402(a)(1) of the act,

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without regard to the criteria in para- § 509.15 Use of polychlorinated graph (b) of this section or in section biphenyls (PCB’s) in establishments 406 of the act. An action level will be manufacturing food-packaging ma- withdrawn when a tolerance or regu- terials. latory limit for the same substance and (a) Polychlorinated biphenyls (PCB’s) use has been established. represent a class of toxic industrial (e) Tolerances will be established chemicals manufactured and sold under under authority appropriate for action a variety of trade names, including: levels (sections 306, 402(a), and 701(a) of Aroclor (United States); Phenoclor the act, together with section 408 or 409 (France); Colphen (Germany); and of the act, if appropriate) as well as Kanaclor (Japan). PCB’s are highly sta- under authority appropriate for toler- ble, heat resistant, and nonflammable ances (sections 406 and 701 of the act). chemicals. Industrial uses of PCB’s in- In the event the effectiveness of a tol- clude, or did include in the past, their erance is stayed pursuant to section use as electrical transformer and ca- 701(e)(2) of the act by the filing of an pacitor fluids, heat transfer fluids, hy- objection, the order establishing the draulic fluids, and plasticizers, and in tolerance shall be deemed to be an formulations of lubricants, coatings, order establishing an action level until and inks. Their unique physical and final action is taken upon such objec- chemical properties and widespread, tion. uncontrolled industrial applications have caused PCB’s to be a persistent [42 FR 52821, Sept. 30, 1977, as amended at 55 and ubiquitous contaminant in the en- FR 20786, May 21, 1990] vironment, causing the contamination of certain foods. In addition, incidents § 509.7 Unavoidability. have occurred in which PCB’s have di- (a) Tolerances and action levels in rectly contaminated animal feeds as a this part are established at levels based result of industrial accidents (leakage on the unavoidability of the poisonous or spillage of PCB fluids from plant or deleterious substance concerned and equipment). These accidents in turn do not establish a permissible level of caused the contamination of food prod- contamination where it is avoidable. ucts intended for human consumption (b) Compliance with tolerances, regu- (meat, milk and eggs). Investigations latory limits, and action levels does by the Food and Drug Administration not excuse failure to observe either the have revealed that a significant per- requirement in section 402(a)(4) of the centage of paper food-packaging mate- act that food may not be prepared, rial contains PCB’s which can migrate packed, or held under insanitary condi- to the packaged food. The origin of PCB’s in such material is not fully un- tions or the other requirements in this derstood. Reclaimed fibers containing chapter that food manufacturers must carbonless copy paper (contains 3 to 5 observe current good manufacturing percent PCB’s) have been identified as practices. Evidence obtained through a primary source of PCB’s in paper factory inspection or otherwise indi- products. Some virgin paper products cating such a violation renders the have also been found to contain PCB’s, food unlawful, even though the the source of which is generally attrib- amounts of poisonous or deleterious uted to direct contamination from in- substances are lower than the cur- dustrial accidents from the use of PCB- rently established tolerances, regu- containing equipment and machinery latory limits, or action levels. The in food-packaging manufacturing es- 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 FR 20786, May 21, 1990] resents a hazard to public health. It is therefore necessary to place certain restrictions on the industrial uses of

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

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(3) 10 parts per million in paper food- containing new animal drugs for which packaging material intended for or an approved medicated feed mill license used with finished animal feed and any application is in effect. components intended for animal feeds. 510.305 Maintenance of copies of approved medicated feed mill licenses to manufac- The tolerance shall not apply to paper ture animal feed bearing or containing food-packaging material separated new animal drugs. from the food therein by a functional 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, and ophthalmic use in animals; warnings Biphenyls, February 1973’’ for deter- and labeling requirements. mining compliance with the tolerances 510.440 Injectable iron preparations. established in this section is available 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 Applications FR 8460, Jan. 27, 1981; 59 FR 14365, Mar. 28, 1994; 68 FR 24879, May 9, 2003] 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. Subpart C—Regulatory Limits for AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 353, Added Poisonous or Delete- 360b, 371, 379e. rious Substances [Reserved] SOURCE: 40 FR 13807, Mar. 27, 1975, unless otherwise noted. Subpart D—Naturally Occurring Poisonous or Deleterious Sub- Subpart A—General Provisions stances [Reserved] § 510.3 Definitions and interpretations. PART 510—NEW ANIMAL DRUGS As used in this part: (a) The term act means the Federal Subpart A—General Provisions 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. of Health and Human Services. 510.7 Consignees of new animal drugs for (c) Secretary means the Secretary of use in the manufacture of animal feed. Health and Human Services. 510.95 [Reserved] (d) Commissioner means the Commis- sioner of Food and Drugs. Subpart B—Specific Administrative Rulings (e) Person means individuals, partner- and Decisions ships, corporations, and associations. 510.105 Labeling of drugs for use in milk- (f) The definitions and interpreta- producing animals. tions of terms contained in section 201 510.106 Labeling of antibiotic and anti- of the act shall be applicable to such biotic-containing drugs intended for use terms when used in the regulations in in milk-producing animals. this part. 510.110 Antibiotics used in food-producing 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; re- other than man, including any drug in- quired data. tended for use in animal feed but not including such animal feed: Subpart C [Reserved] (1) The composition of which is such that such drug is not generally recog- Subpart D—Records and Reports nized, among experts qualified by sci- 510.301 Records and reports concerning ex- entific training and experience to perience with animal feeds bearing or evaluate the safety and effectiveness of

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

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

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

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

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

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

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(1) ALPHABETICAL LISTING OF SPONSORS

Drug labeler Firm name and address code

A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., Jackson, NJ 08527 ...... 057699 Accord Healthcare, Inc., 1009 Slater Rd., suite 210–B, Durham, NC 27703 ...... 016729 ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305–3115 ...... 012286 Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503 ...... 057561 Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112 ...... 017762 Akorn Animal Health, Inc., 1925 West Field Ct., suite 300, Lake Forest, IL 60045 ...... 059399 Alaco, Inc., 1500 North Wilmot Rd., suite 290–C, Tucson, AZ 85712 ...... 064146 Alexion Pharmaceuticals, Inc., 100 College St., New Haven, CT 06510 ...... 069334 American Regent, Inc., Animal Health Division, Shirley, NY 11967 ...... 010797 Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 01801 ...... 060865 Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043 ...... 086073 AquaBounty Technologies, Inc., 2 Mill and Main Pl., Suite 395, Maynard, MA 01754 ...... 086053 Ark Sciences, Inc., 1101 East 33rd St., suite B304, Baltimore, MD 21218 ...... 076175 Aurora Pharmaceutical, Inc., 1196 Highway 3 South, Northfield, MN 55057–3009 ...... 051072 Axcentive SARL, Chemin de Champouse, Quartier Violesi, 13320 Bouc Bel Air, France ...... 086009 B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756 ...... 067188 Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807 ...... 099207 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 Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland ...... 061133 Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096 ...... 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 Cronus Pharma Specialities India Private Ltd., Sy No: 99/1, M/s GMR Hyderabad Aviation SEZ L, Mamidipalli Village, Shamshabad Mandal, Ranga, Hyderabad, Telangana, 501218, India ...... 069043 Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom .... 043264 Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211 ...... 026637 ECO LLC, 344 Nassau St., Princeton, NJ 08540 ...... 066916 Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 ...... 058198 Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013–3928 ...... 017135 First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123 ...... 058829 Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., Melville, NY 11747 ...... 025463 G. C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 13201 ...... 010515 GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702 ...... 042976 Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200, Peachtree Corners, GA 30092 ...... 012164 Happy Jack, Inc., Snow Hill, NC 28580 ...... 023851 Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., Souderton, PA 18964 ...... 063075 Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525 ...... 063604 Hikma International Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118 ...... 059115 HQ Specialty Pharma Corp., 120 Rte. 17 North, suite 130, Paramus, NJ 07652 ...... 042791 Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria ...... 016592 IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544 ...... 000115 Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 ...... 000061 Ivaoes Animal Health, 4300 SW 73rd Ave., suite 110, Miami, FL 33155 ...... 086064 Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320, Australia ...... 049480 Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite 200, Burlingame, CA 94010 ...... 086078 Kinetic Technologies, LLC, 961 Beasley St., suite 270, Lexington, KY 40509 ...... 051031 LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702 ...... 086047 Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601 ...... 061690 Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767–1861 ...... 054925 Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432 ...... 086039 Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186 ...... 015914 Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478 ...... 051079 Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103 ...... 063286 Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, MS 39120 ...... 049968 Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511 ...... 059051 Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland ...... 055529 Oasmia Pharmaceutical AB, Vallongatan 1, 75228 Uppsala, Sweden ...... 052818 Orion Corp., Orionintie 1, 02200 Espoo, Finland ...... 052483 OXIS International, Inc., 6040 N. Cutter Circle, suite 317, Portland, OR 97217–3935 ...... 024991 Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia ...... 068504 Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514 ...... 055246 Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona, NY 10970 ...... 050057 Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ 07069 ...... 042552 Pharmaq AS, Skogmo Industriomrade, N–7863 Overhalla, Norway ...... 015331 Pharmgate, Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405 ...... 069254 Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666 ...... 066104

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(1) ALPHABETICAL LISTING OF SPONSORS—Continued

Drug labeler Firm name and address code

Piramal Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017 ...... 066794 Piramal Enterprises Ltd., Ananta, Agastya Corporate Park, Opp Fire Brigade, Kamani Junction, LBS Mag Kurla (West), Mumbai, 400070, India ...... 065085 Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053–120, Campinas, Sao Paulo, Brazil ...... 060728 Purina Animal Nutrition LLC, 1080 County Road F West, Shoreview, MN 55126–2910 ...... 017800 Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349 ...... 076475 Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001 ...... 067949 RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620 ...... 058670 Sergeant’s Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138 ...... 021091 Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215 ...... 058005 Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151 ...... 017153 Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752 ...... 037990 Superior Equine Pharmaceuticals, Inc., Pleasant Grove, UT 84062 ...... 027053 Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248 ...... 050378 Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532 ...... 051672 Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503 ...... 052923 Thorn Bioscience LLC, 1044 East Chestnut St., Louisville, KY 40204 ...... 051330 Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901 ...... 086106 United-AH II LLC, 322 S Main St., Sheridan, IN 46069 ...... 051233 VetDC, Inc., 320 E. Vine Dr., suite 218, Fort Collins, CO 80524 ...... 086072 Ve´toquinol N.–A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5 ...... 059320 Ve´toquinol USA, Inc., 4250 N. Sylvania Ave., Fort Worth, TX 76137 ...... 017030 Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161 ...... 051311 Walco International, Inc., 15 West Putnam, Porterville, CA 93257 049185 Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616 ...... 086113 Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550 ...... 053923 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 ...... 054771

(2) NUMERICAL LISTING OF SPONSORS

Drug labeler code Firm name and address

000010 Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096. 000061 Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940. 000115 IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544. 000859 Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201. 010515 G. C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 13201. 010797 American Regent, Inc., Animal Health Division, Shirley, NY 11967. 012164 Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200, Peachtree Corners, GA 30092. 012286 ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305–3115. 012578 Janssen Pharmaceutica NV, Turnhoutseweg 30, B–2340 Beerse, Belgium. 013744 Ceva Sante Animale, 10 Avenue de la Ballastie`re, 33500 Libourne, France. 015331 Pharmaq AS, Skogmo Industriomrade, N–7863 Overhalla, Norway. 015914 Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186. 016592 Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria. 016729 Accord Healthcare, Inc., 1009 Slater Rd., suite 210–B, Durham, NC 27703. 017030 Ve´toquinol USA, Inc., 4250 N. Sylvania Ave., Fort Worth, TX 76137. 017135 Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013–3928. 017153 Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151. 017762 Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112. 017800 Purina Animal Nutrition, 1080 County Road F West, Shoreview, MN 55126–2910. 021091 Sergeant’s Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138. 023851 Happy Jack, Inc., Snow Hill, NC 28580. 024991 OXIS International, Inc., 6040 N. Cutter Circle, suite 317 Portland, OR 97217–3935. 025463 Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., Melville, NY 11747. 026637 Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211. 027053 Superior Equine Pharmaceuticals, Inc., Pleasant Grove, UT 84062. 037990 Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752. 042552 Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ 07069. 042791 HQ Specialty Pharma Corp., 120 Rte. 17 North, suite 130, Paramus, NJ 07652. 042976 GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702. 043264 Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom. 049185 Walco International, Inc., 15 West Putnam, Porterville, CA 93257. 049480 Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320, Australia. 049968 Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, MS 39120. 050057 Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona, NY 10970. 050378 Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248. 051031 Kinetic Technologies, LLC, 961 Beasley St., suite 270, Lexington, KY 40509. 051072 Aurora Pharmaceutical, Inc., 1196 Highway 3 South, Northfield, MN 55057–3009.

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(2) NUMERICAL LISTING OF SPONSORS—Continued

Drug labeler code Firm name and address

051079 Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478. 051233 United-AH II LLC, 322 S Main St., Sheridan, IN 46069. 051311 Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161. 051330 Thorn Bioscience LLC, 1044 East Chestnut St., Louisville, KY 40204. 051672 Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532. 052483 Orion Corp., Orionintie 1, 02200 Espoo, Finland. 052818 Oasmia Pharmaceutical AB, Vallongatan 1, 75228 Uppsala, Sweden. 052923 Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503. 053923 Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550. 054771 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. 054925 Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767–1861. 055246 Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514. 055529 Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland. 057561 Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503. 057699 A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., Jackson, NJ 08527. 058005 Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215. 058198 Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140. 058670 RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620. 058829 First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123. 059051 Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511. 059115 Hikma International Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118. 059320 Ve´toquinol N.–A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5. 059399 Akorn Animal Health, Inc., 1925 West Field Ct., suite 300, Lake Forest, IL 60045. 060728 Planalquimica Industrial Ltda., Rua das Magnolias nr. Jardim das Bandeiras, CEP 13053–120, Campinas, Sao Alto, Brazil. 060865 Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 01801. 061133 Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland. 061651 Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland. 061690 Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601. 062250 Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777. 062794 Mylan Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478. 063075 Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., Souderton, PA 18964. 063286 Mylan Institutional, LLC, 4901 Hiawatha Dr., Rockford, IL 61103. 063604 Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525. 064146 Alaco, Inc., 1500 North Wilmot Rd., suite 290–C, Tucson, AZ 85712. 065085 Piramal Enterprises Ltd., Ananta, Agastya Corporate Park, Opp Fire Brigade, Kamani Junction, LBS Mag Kurla (West), Mumbai, 400070, India. 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 USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001. 068330 Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767. 068504 Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia. 069043 Cronus Pharma Specialities India Private Ltd., Sy No: 99/1, M/s GMR Hyderabad Aviation SEZ L, Mamidipalli Village, Shamshabad Mandal, Ranga, Hyderabad, Telangana, 501218, India. 069254 Pharmgate, Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405. 069334 Alexion Pharmaceuticals, Inc., 100 College St., New Haven, CT 06510. 076175 Ark Sciences, Inc., 1101 East 33rd St., suite B304, Baltimore, MD 21218. 076475 Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349. 086009 Axcentive SARL, Chemin de Champouse, Quartier Violesi, 13320 Bouc Bel Air, France. 086039 Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432. 086047 LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702. 086053 AquaBounty Technologies, Inc., 2 Mill and Main Pl., Suite 395, Maynard, MA 01754. 086064 Ivaoes Animal Health, 4300 SW 73rd Ave., suite 110, Miami, FL 33155. 086072 VetDC, Inc., 320 E Vine Dr., suite 218, Fort Collins, CO 80524. 086073 Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043. 086078 Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite 200, Burlingame, CA 94010. 086106 Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901. 086113 Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616. 099207 Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.

[40 FR 13807, Mar. 27, 1975]

EDITORIAL NOTES: 1. For FEDERAL REGISTER citations affecting § 510.600, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

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2. At 77 FR 46613, Aug. 6, 2012, § 510.600 was amended by removing the entry for ‘‘012758’’ in the table in paragraph (c)(2); however, the amendment could not be incorporated because ‘‘012758’’ didn’t exist.

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

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

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

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Medicine, the Center will discontinue be ineligible to receive FDA-regulated the disqualification proceeding. If an test articles is subject to examination explanation is offered but not accepted to determine whether the investigator by the Center for Veterinary Medicine, has submitted unreliable data that are the investigator will be given an oppor- essential to the continuation of an in- tunity for a regulatory hearing under vestigation or essential to the approval part 16 of this chapter on the question of a marketing application, or essen- of whether the investigator is eligible tial to the continued marketing of an to receive test articles under this part FDA-regulated product. and eligible to conduct: (4) If the Commissioner determines, (i) Any clinical investigation that after the unreliable data submitted by supports an application for a research the investigator are eliminated from or marketing permit for products regu- consideration, that the data remaining lated by FDA; and are inadequate to support a conclusion (ii) Any nonclinical laboratory study that it is reasonably safe to continue intended to support an application for the investigation, the Commissioner a research or marketing permit for a will notify the sponsor, who shall have new animal drug. an opportunity for a regulatory hear- (2) After evaluating all available in- ing under part 16 of this chapter. If a formation, including any explanation danger to the public health exists, how- presented by the investigator, if the ever, the Commissioner shall termi- Commissioner determines that the in- nate the exemption immediately and vestigator has repeatedly or delib- notify the sponsor of the termination. erately failed to comply with the con- In such case, the sponsor shall have an ditions of the exempting regulations in opportunity for a regulatory hearing this subchapter, or has repeatedly or before FDA under part 16 on the ques- deliberately submitted to FDA or to tion of whether the exemption should the sponsor false information in any be reinstated. The determination that required report, the Commissioner will an investigation may not be considered notify the investigator and the sponsor in support of a research or marketing of any investigation in which the in- application or a notification or peti- vestigator has been named as a partici- tion submission does not, however, re- pant that the investigator is not eligi- lieve the sponsor of any obligation ble to receive test articles under this under any other applicable regulation part. The notification to the investi- to submit to FDA the results of the in- gator and sponsor will provide a state- vestigation. ment of the basis for such determina- (5) If the Commissioner determines, tion. The notification also will explain after the unreliable data submitted by that an investigator determined to be the investigator are eliminated from ineligible to receive test articles under consideration, that the continued ap- this part will be ineligible to conduct: proval of the product for which the (i) Any clinical investigation that data were submitted cannot be justi- supports an application for a research fied, the Commissioner will proceed to or marketing permit for products regu- withdraw approval of the product in ac- lated by FDA, including drugs, bio- cordance with the applicable provisions logics, devices, new animal drugs, of the relevant statutes. foods, including dietary supplements, (6) An investigator who has been de- that bear a nutrient content claim or a termined to be ineligible under para- health claim, infant formulas, food and graph (c)(2) of this section may be rein- color additives, and tobacco products; stated as eligible when the Commis- and sioner determines that the investigator (ii) Any nonclinical laboratory study has presented adequate assurances that intended to support an application for the investigator will employ all test a research or marketing permit for a articles, and will conduct any clinical new animal drug. 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 and ter containing data reported by an in- any nonclinical laboratory study investigator who has been determined to tended to support an application for a

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research or marketing permit for a new written description shall be deemed not animal drug, solely in compliance with to have been transferred. the applicable provisions of this chap- (3) A contract research organization ter. that assumes any obligation of a spon- (d) Termination of exemption. If the sor shall comply with the specific regu- Commissioner finds that: lations in this chapter applicable to (1) The sponsor of the investigation this obligation and shall be subject to has failed to comply with any of the the same regulatory action as a spon- conditions for the exemption estab- sor for failure to comply with any obli- lished under this section, or gation assumed under these regula- (2) The continuance of the investigations. Thus, all references to sponsor in tion is unsafe or otherwise contrary to this part apply to a contract research the public interest or the drug is being organization to the extent that it as- or has been used for purposes other sumes one or more obligations of the than bona fide scientific investigation, sponsor. he shall first notify the sponsor and in- (g) Index of legally marketed unap- vite his immediate correction. If the proved new animal drugs for minor spe- conditions of the exemption are not cies. All provisions of part 511 apply to immediately met, the sponsor shall new animal drugs for investigational have an opportunity for a regulatory use in support of indexing, as described hearing before FDA pursuant of part 16 in section 572 of the act, subject to the of this chapter on whether the exemp- provisions of § 516.125 of this chapter. tion should be terminated. If the ex- [40 FR 13823, Mar. 27, 1975, as amended at 41 emption is terminated the sponsor FR 48268, Nov. 2, 1976; 42 FR 15675, Mar. 22, shall recall or have destroyed the un- 1977; 50 FR 7517, Feb. 22, 1985; 50 FR 16668, used supplies of the new animal drug. Apr. 26, 1985; 52 FR 8847, Mar. 19, 1987; 54 FR (e) Statements and requests. ‘‘Notice(s) 18280, Apr. 28, 1989; 57 FR 6475, Feb. 25, 1992; of Claimed Investigational Exemption 62 FR 40599, July 29, 1997; 72 FR 69121, Dec. 6, for a New Animal Drug’’ and requests 2007; 77 FR 25359, Apr. 30, 2012; 82 FR 61446, for authorization to use investigational Dec. 28, 2017] animals and their products for food § 511.3 Definitions. should be addressed to the Department of Health and Human Services, Food As used in this part: and Drug Administration, Center for Contract research organization means a Veterinary Medicine, 7500 Standish Pl., person that assumes, as an independent Rockville, MD 20855. contractor with the sponsor, one or (f) Contract research organizations. (1) more of the obligations of a sponsor, For purposes of this part and part 514, e.g., design of a protocol, selection or contract research organization means a monitoring of investigations, evalua- person that assumes, as an independent tion of reports, and preparation of ma- contractor with the sponsor, one or terials to be submitted to the Food and more of the obligations of a sponsor, Drug Administration. e.g., design of a protocol, selection or Investigator means an individual who monitoring of investigations, evalua- actually conducts a clinical investigation of reports, and preparation of mation (i.e., under whose immediate di- terials to be submitted to FDA. rection the drug is administered or dis- (2) A sponsor may transfer responsi- pensed to a subject). In the event an in- bility for any or all of the obligations vestigation is conducted by a team of set forth in this part to a contract re- individuals, the investigator is the research organization. Any such transfer sponsible leader of the team. ‘‘Sub- shall be in writing and, if not all obli- investigator’’ includes any other indi- gations are transferred, shall describe vidual member of that team. each of the obligations being assumed Sponsor means a person who takes re- by the contract research organization. sponsibility for and initiates a clinical If all obligations are transferred, a gen- investigation. The sponsor may be an eral statement that all obligations individual or pharmaceutical company, have been transferred is acceptable. governmental agency, academic insti- Any obligation not covered by the tution, private organization, or other

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organization. The sponsor does not ac- 514.116 Notice of withdrawal of approval of tually conduct the investigation unless application. the sponsor is a sponsor-investigator. A 514.117 Adequate and well-controlled stud- person other than an individual that ies. 514.120 Revocation of order refusing to ap- uses one or more of its own employees prove an application or suspending or to conduct an investigation that it has withdrawing approval of an application. initiated is a sponsor, not a sponsor-in- 514.121 Service of notices and orders. vestigator, and the employees are investigators. Subpart C—Hearing Procedures Sponsor-Investigator means an indi- 514.200 Notice of opportunity for hearing; vidual who both initiates and conducts notice of participation and requests for an investigation, and under whose im- hearing; grant or denial of hearing. mediate direction the investigational 514.201 Procedures for hearings. drug is administered or dispensed. The term does not include any person other Subparts D–E [Reserved] than an individual. The requirements applicable to a sponsor-investigator Subpart F—Judicial Review under this part include both those ap- 514.235 Judicial review. plicable to an investigator and a sponsor. AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 360ccc, 371, 379e, 381.

[77 FR 25359, Apr. 30, 2012] SOURCE: 40 FR 13825, Mar. 27, 1975, unless otherwise noted. PART 514—NEW ANIMAL DRUG APPLICATIONS Subpart A—General Provisions

Subpart A—General Provisions § 514.1 Applications. (a) Applications to be filed under sec- Sec. 514.1 Applications. tion 512(b) of the act shall be submitted 514.3 Definitions. in the form and contain the informa- 514.4 Substantial evidence. tion described in paragraph (b) of this 514.5 Presubmission conferences. section, as appropriate to support the 514.6 Amended applications. particular submission. If any part of 514.7 Withdrawal of applications without the application is in a foreign lan- prejudice. guage, an accurate and complete 514.8 Supplements and other changes to an English translation shall be appended approved application. to such part. Translations of literature 514.11 Confidentiality of data and informa- printed in a foreign language shall be tion in a new animal drug application file. accompanied by copies of the original 514.12 Confidentiality of data and informa- publication. The application must be tion in an investigational new animal signed by the applicant or by an au- drug notice. thorized attorney, agent, or official. If 514.15 Untrue statements in applications. the applicant or such authorized representative does not reside or have a Subpart B—Administrative Actions on place of business within the United Applications States, the application must also fur- 514.80 Records and reports concerning expe- nish the name and post office address rience with approved new animal drugs. of, and must be countersigned by, an 514.87 Annual reports for antimicrobial ani- authorized attorney, agent, or official mal drug sales and distribution. residing or maintaining a place of busi- 514.100 Evaluation and comment on applica- ness within the United States. Perti- tions. nent information may be incorporated 514.105 Approval of applications. in, and will be considered as part of, an 514.106 Approval of supplemental applica- application on the basis of specific ref- tions. 514.110 Reasons for refusing to file applica- erence to such information, including tions. information submitted under the provi- 514.111 Refusal to approve an application. sions of § 511.1 of this chapter, in the 514.115 Withdrawal of approval of applica- files of the Food and Drug Administra- tions. tion; however, the reference must be

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specific in identifying the information. (d) Conclusions: A short statement of Any reference to information furnished conclusions combining the major by a person other than the applicant points of effectiveness and safety as may not be considered unless its use is they relate to the use of the new ani- authorized in a written statement mal drug. signed by the person who submitted it. (3) Labeling. Three copies of each (b) Applications for new animal drugs piece of all labeling to be used for the shall be submitted in triplicate and as- article (total of 9). sembled in the manner prescribed by (i) All labeling should be identified to paragraph (b)(15) of this section, and show its position on, or the manner in shall include the following informa- which it is to accompany the market tion, as appropriate to support the par- package. ticular submission: (ii) Labeling for nonprescription new (1) Identification. Whether the submis- animal drugs should include adequate sion is an original or supplemental ap- directions for use by the layman under plication; the name and the address of all conditions of use for which the new the applicant; the date of the applica- animal drug is intended, recommended, tion; the trade name(s) (if one has been or suggested in any of the labeling or proposed) and chemical name(s) of the advertising sponsored by the applicant. new animal drug. Upon receipt, the ap- (iii) Labeling for prescription veteri- plication will be assigned a number nary drugs should bear adequate infor- NADA ll, which shall be used for all mation for use under which veterinar- correspondence with respect to the ap- ians can use the new animal drug safe- plication. ly and for the purposes for which it is (2) Table of contents and summary. The intended, including those purposes for application shall be organized in a co- which it is to be advertised or rep- hesive fashion, shall contain a table of resented, in accord with § 201.105 of this contents which identifies the data and chapter. other material submitted, and shall (iv) All labeling for prescription or contain a well-organized summary and nonprescription new animal drugs shall evaluation of the data in the following be submitted with any necessary use form: restrictions prominently and conspicu- (i) Chemistry: ously displayed. (a) Chemical structural formula or (v) Labeling for new animal drugs in- description for any new animal drug tended for use in the manufacture of substance. medicated feeds shall include: (b) Relationship to other chemically (a) Specimens of labeling to be used or pharmacologically related drugs. for such new animal drug with ade- (c) Description of dosage form and quate directions for the manufacture quantitative composition. and use of finished feeds for all condi- (ii) Scientific rationale and purpose tions for which the new animal drug is the new animal drug is to serve: intended, recommended, or suggested (a) Clinical purpose. in any of the labeling, including adver- (b) Highlights of laboratory studies: tising, sponsored by the applicant. In- The reasons why certain types of stud- gredient labeling may utilize collective ies were done or omitted as related to names as provided in § 501.110 of this the proposed conditions of use and to chapter. information already known about this (b) Representative labeling proposed class of compounds. Emphasize any un- to be used for Type B and Type C medi- usual or particularly significant phar- cated feeds containing the new animal macological effects or toxicological drug. findings. (vi) Draft labeling may be submitted (c) Highlights of clinical studies: The for preliminary consideration of an ap- rationale of the clinical study plan plication. Final printed labeling will showing why types of studies were ordinarily be required prior to approval done, amended, or omitted as related of an application. Proposed advertising to laboratory studies and prior clinical for veterinary prescription drugs may experience. be submitted for comment or approval.

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

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

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

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

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in the scientific literature, both favor- (ix) If original subject records were able and unfavorable, involving the audited or reviewed by the sponsor in new animal drug that is the subject of the course of monitoring any clinical the application and related new animal study to verify the accuracy of the case drugs shall be submitted. An adequate reports submitted to the sponsor, a list summary may be acceptable in lieu of identifying each clinical study so au- a reprint of a published report that dited or reviewed. only supports other data submitted. In- (9) Veterinary feed directive. Three clude any evaluation of the safety or copies of a veterinary feed directive effectiveness of the new animal drug (VFD) must be submitted in a form that has been made by the applicant’s that accounts for the information de- veterinary or medical department, ex- scribed under §§ 558.6(b)(3) and pert committee, or consultants. 558.6(b)(4) of this chapter. (v) If the new animal drug is a com- (10) Supplemental applications. If it is bination of active ingredients or ani- a supplemental application, full informal drugs, an application may be re- mation shall be submitted on each pro- fused unless it includes substantial evi- posed change concerning any state- dence of the effectiveness of the comment made in the approved applica- bination new animal drug as required tion. in § 514.4. (11) Applicant’s commitment. It is un- (vi) An application shall include a derstood that the labeling and adver- complete list of the names and post of- tising for the new animal drug will pre- fice addresses of all investigators who scribe, recommend, or suggest its use received the new animal drug. This only under the conditions stated in the may be incorporated in whole or in labeling which is part of this applica- part by reference to information sub- tion and if the article is a prescription mitted under the provisions of § 511.1 of new animal drug, it is understood that this chapter. any labeling which furnishes or pur- (vii) Explain any omission of reports ports to furnish information for use or from any investigator to whom the in- which prescribes, recommends, or sug- vestigational new animal drug has been gests a dosage for use of the new ani- made available. The unexplained omis- mal drug will also contain, in the same sion of any reports of investigations language and emphasis, information made with the new animal drug by the for its use including indications, ef- applicant or submitted to him by an in- fects, dosages, routes, methods, and vestigator or the unexplained omission frequency and duration of administra- of any pertinent reports of investigation, any relevant hazards, contra- tions or clinical experience received or indications, side effects, and pre- otherwise obtained by the applicant cautions contained in the labeling from published literature or other which is part of this application. It is sources that would bias an evaluation understood that all representations in of the safety of the new animal drug or this application apply to the drug pro- its effectiveness in use, constitutes duced until changes are made in con- grounds for the refusal or withdrawal formity with § 514.8. of the approval of an application. (12) Additional commitments. (i) New (viii) If a sponsor has transferred any animal drugs as defined in § 510.3 of this obligations for the conduct of any clin- chapter, intended for use in the manu- ical study to a contract research orga- facture of animal feeds in any State nization, the application is required to will be shipped only to persons who include a statement containing the may receive such drugs in accordance name and address of the contract re- with § 510.7 of this chapter. search organization, identifying the (ii) The methods, facilities, and con- clinical study, and listing the obliga- trols described under item 5 of this ap- tions transferred. If all obligations gov- plication conform to the current good erning the conduct of the study have manufacturing practice regulations in been transferred, a general statement subchapter C of this chapter. of this transfer—in lieu of a listing of (iii) With respect to each nonclinical the specific obligations transferred— laboratory study contained in the ap- may be submitted. plication, either a statement that the

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study was conducted in compliance (c) When a new animal drug applica- with the good laboratory practice regu- tion is submitted for a new animal lations set forth in part 58 of this chap- drug which has a stimulant, depres- ter, or, if the study was not conducted sant, or hallucinogenic effect on the in compliance with such regulations, a central nervous system, if it appears brief statement of the reason for the that the drug has a potential for abuse, noncompliance. the Commissioner shall forward that (13) [Reserved] information to the Attorney General of (14) Environmental assessment. The ap- the United States. plicant is required to submit either a [40 FR 13825, Mar. 27, 1975] claim for categorical exclusion under § 25.30 or § 25.33 of this chapter or an en- EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 514.1, see the List of CFR vironmental assessment under § 25.40 of Sections Affected, which appears in the this chapter. Finding Aids section of the printed volume (15) Assembling and binding the appli- and at www.govinfo.gov. cation. Assemble and bind an original and two copies of the application as § 514.3 Definitions. follows: The definition and interpretation of (i) Bind the original or ribbon copy of terms contained in this section apply the application as copy No. 1. to those terms as used throughout sub- (ii) Bind two identical copies as copy chapter E. No. 2 and copy No. 3. Adverse drug experience is any adverse (iii) Identify each front cover with event associated with the use of a new the name of the applicant, new animal animal drug, whether or not considered drug, and the copy number. to be drug related, and whether or not (iv) Number each page of the applica- the new animal drug was used in action sequentially in the upper right cordance with the approved labeling hand corner or in another location so (i.e., used according to label directions that the page numbers remain legible or used in an extralabel manner, in- after the application has been bound, cluding but not limited to different and organize the application consistent route of administration, different spe- with paragraphs (b) (1) through (14) of cies, different indications, or other this section. Each copy should bear the than labeled dosage). Adverse drug ex- same page numbering, whether sequen- perience includes, but is not limited to: tial in each volume or continuous and (1) An adverse event occurring in ani- sequential throughout the application. mals in the course of the use of an ani- (v) Include complete labeling in each mal drug product by a veterinarian or of the copies. It is suggested that label- by a livestock producer or other ani- ing be identified by date of printing or mal owner or caretaker. date of preparation. (2) Failure of a new animal drug to (vi) Submit separate applications for produce its expected pharmacological each different dosage form of the drug or clinical effect (lack of expected ef- proposed. Repeating basic information fectiveness). pertinent to all dosage forms in each (3) An adverse event occurring in hu- application is unnecessary if reference mans from exposure during manufac- is made to the application containing ture, testing, handling, or use of a new such information. Include in each ap- animal drug. plication information applicable to the ANADA is an abbreviated new animal specific dosage form, such as labeling, drug application including all amend- composition, stability data, and meth- ments and supplements. od of manufacture. Applicant is a person or entity who (vii) Submit in folders amendments, owns or holds on behalf of the owner supplements, and other correspondence the approval for an NADA or an sent after submission of an original ap- ANADA, and is responsible for compli- plication. The front cover of these sub- ance with applicable provisions of the missions should be identified with the act and regulations. name of the applicant, new animal Increased frequency of adverse drug ex- drug, copy number, and the new animal perience is an increased rate of occur- drug application number, if known. rence of a particular serious adverse

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

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

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(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 ingredient or animal drug in the com- animal drugs, the sponsor shall dem- bination makes a contribution to the onstrate by substantial evidence, as de- effectiveness of the combination new fined in this section, that the combina- animal drug; tion new animal drug will have the ef- (B) That each active ingredient or fect it purports or is represented to animal drug intended for at least one have under the conditions of use pre- use that is different from all the other scribed, recommended, or suggested in active ingredients or animal drugs used the proposed labeling and that each ac- in the combination provides appro- tive ingredient or animal drug contrib- priate concurrent use for the intended utes to the effectiveness of the com- target animal population; and bination new animal drug. (C) That the active ingredients or [64 FR 40756, July 28, 1999] animal drugs are physically compatible and do not have disparate dosing regi- § 514.5 Presubmission conferences. mens if FDA, based on scientific infor- (a) General principle underlying the mation, has reason to believe the ac- conduct of a presubmission conference. tive ingredients or animal drugs are The general principle underlying the physically incompatible or have dis- conduct of any presubmission con- parate dosing regimens. ference is that there should be candid, (ii) For combination new animal full, and open communication. drugs intended for use in animal feed (b) Requesting a presubmission con- or drinking water that contain only ac- ference. A potential applicant is enti- tive ingredients or animal drugs that tled to one or more conferences prior have previously been separately ap- to the submission of an NADA, supple- proved for the particular uses and con- mental NADA, or an ANADA to reach ditions of use for which they are in- an agreement establishing part or all tended in combination, the sponsor of a submission or investigational re- shall demonstrate: quirement. A potential applicant’s request for a presubmission conference (A) By substantial evidence, as de- must be submitted to FDA in a signed fined in this section, that any active letter. The letter must include a pro- ingredient or animal drug intended posed agenda that clearly outlines the only for the same use as another active scope, purpose, and objectives of the ingredient or animal drug in the com- presubmission conference and must list bination makes a contribution to the the names and positions of the rep- effectiveness of the combination new resentatives who are expected to at- animal drug; tend the presubmission conference on (B) For such combination new animal behalf of the applicant. drugs that contain more than one anti- (c) Timing. A potential applicant may bacterial ingredient or animal drug, by request one or more presubmission con- substantial evidence, as defined in this ferences at any time prior to the filing section, that each antibacterial makes of a NADA, supplemental NADA, or an a contribution to labeled effectiveness; ANADA. A request for a presubmission (C) That each active ingredient or conference must be received by FDA at animal drug intended for at least one least 30 calendar days in advance of the use that is different from all other ac- requested conference date. FDA will tive ingredients or animal drugs used schedule the presubmission conference in the combination provides appro- at a time agreeable to both FDA and priate concurrent use for the intended the potential applicant. target animal population; and (d) Advance information. The potential (D) That the active ingredients or applicant must provide to FDA, at animal drugs intended for use in drink- least 30 calendar days before a sched- ing water are physically compatible if uled presubmission conference, a de- FDA, based on scientific information, tailed agenda, a copy of any materials has reason to believe the active ingre- to be presented at the conference, a list

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of proposed indications and, if avail- endar days after the date of the con- able, a copy of the proposed labeling ference for the product under consideration, (iii) Requests for changes or clarifica- and copies of materials evaluated or tion. If a potential applicant requests referenced relative to issues listed in changes to, or clarification of, the sub- the agenda for the conference. If the stance of the memorandum, the re- materials are not provided or are not quest must be sent to FDA within 30 sufficient to provide the basis for calendar days from the date a copy of meaningful discussion, FDA may elect the memorandum is sent to the appli- to postpone part or all of the meeting cant. If the potential applicant re- until sufficient materials are provided quests changes or clarification, FDA to FDA. will send the potential applicant a re- (e) Conduct of a presubmission con- sponse to their request no later than 45 ference. The potential applicant and calendar days after the date of receipt FDA may each bring consultants to the of the request. presubmission conference. The pre- (iv) Administrative record. A copy of submission conference(s) will be di- FDA’s original memorandum of con- rected primarily at establishing agree- ference and, as appropriate, a copy of ment between FDA and the potential an amended memorandum to correct or applicant regarding a submission or in- clarify the content of the original vestigational requirement. The submis- memorandum will be made part of the sion or investigational requirement administrative file. may include, among other things, the (2) Field studies. If FDA requires more number, types, and general design of than one field study to establish by studies that are necessary to dem- substantial evidence that the new ani- onstrate the safety and effectiveness of mal drug is effective for its intended a new animal drug for the intended uses under the conditions of use pre- uses and conditions of use prescribed, scribed, recommended, or suggested in recommended, or suggested in the pro- the proposed labeling, FDA will provide posed labeling for the new animal drug. written scientific justification for re- (f) Documentation of a presubmission conference—(1) Memorandum of con- quiring more than one field study. ference—(i) Preparation. FDA will pre- Such justification must be provided no pare a memorandum for each pre- later than 25 calendar days after the submission conference that will in- date of the conference at which the re- clude, among other things, any back- quirement for more than one field ground pertinent to the request for study is established. If FDA does not meeting; a summary of the key points believe more than one field study is re- of discussion; agreements; and action quired but the potential applicant vol- items and assignments of responsi- untarily proposes to conduct more bility. That portion of the memo- than one field study, FDA will not pro- randum of conference that documents vide such written justification. If FDA any agreements reached regarding all requires one field study to be con- or part of a submission or investiga- ducted at multiple locations, FDA will tional requirement will be included provide justification for requiring mul- under the heading ‘‘Presubmission Con- tiple locations verbally during the pre- ference Agreement.’’ If the presubmission conference and in writing submission conference agreement sec- as part of the memorandum of con- tion of the memorandum is silent on an ference. issue, including one that was discussed (g) Modification of presubmission con- in the conference or addressed by mate- ference agreements. An agreement made rials provided for the conference, such under a presubmission conference re- silence does not constitute agreement quested under section 512(b)(3) of the between FDA and the potential appli- act and documented in a memorandum cant on the issue. of conference is binding on the poten- (ii) Sending a copy to the potential ap- tial applicant and FDA and may only plicant. FDA will send a copy of the be modified if: memorandum to the potential appli- (1) FDA and the potential applicant cant for review no later than 45 cal- mutually agree to modify, in part or in

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whole, the agreement and such modi- quacy of the manufacturing methods, fication is documented and provided to facilities, and controls to preserve the potential applicant as described in them, in which case the unamended ap- paragraph (f)(1) of this section; or plication may be considered as with- (2) FDA by written order determines drawn and the amended application that a substantiated scientific require- may be considered resubmitted on the ment essential to the determination of date on which the amendment is re- safety or effectiveness of the new ani- ceived by the Food and Drug Adminis- mal drug appeared after the con- tration. The applicant will be notified ference. of such date. (h) When the terms of a presubmission conference agreement are not valid (1) A § 514.7 Withdrawal of applications presubmission conference agreement without prejudice. will no longer be valid if: (i) The potential applicant makes to The sponsor may withdraw his pend- FDA, before, during, or after the pre- ing application from consideration as a submission conference, any untrue new animal drug application upon writ- statement of material fact; or ten notification to the Food and Drug (ii) The potential applicant fails to Administration. Such withdrawal may follow any material term of the agree- be made without prejudice to a future ment; and filing. Upon resubmission, the time (2) A presubmission conference may limitation will begin to run from the no longer be valid if the potential ap- date the resubmission is received by plicant submits false or misleading the Food and Drug Administration. data relating to a new animal drug to The original application will be re- FDA. tained by the Food and Drug Adminis- (i) Dispute resolution. FDA is com- tration although it is considered with- mitted to resolving differences between drawn. The applicant shall be furnished a potential applicant and FDA review- a copy at cost on request. ing divisions with respect to requirements for the investigation of new ani- § 514.8 Supplements and other changes mal drugs and for NADAs, supple- to an approved application. mental NADAs, and ANADAs as quick- ly and amicably as possible through a (a) Definitions. (1) The definitions and cooperative exchange of information interpretations contained in section 201 and views. When administrative or proof the Federal Food, Drug, and Cos- cedural disputes arise, a potential ap- metic Act (the act) apply to those plicant should first attempt to resolve terms when used in this part. the matter within the appropriate re- (2) The following definitions of terms view division beginning with the indi- apply to this part: vidual(s) most directly assigned to the (i) Assess the effects of the change review of the application or investiga- means to evaluate the effects of a man- tional exemption. If the dispute cannot ufacturing change on the identity, be resolved after such attempts, the strength, quality, purity, and potency dispute shall be evaluated and adminis- of a drug as these factors may relate to tered in accordance with applicable the safety or effectiveness of the drug. regulations (21 CFR 10.75). Dispute res- (ii) Drug substance means an active olution procedures may be further ex- ingredient as defined under § 210.3(b)(7) plained by guidance available from the of this chapter. Center for Veterinary Medicine. (iii) Minor changes and stability report [69 FR 51170, Aug. 18, 2004] (MCSR) means an annual report that is submitted to the application once each § 514.6 Amended applications. year within 60 days before or after the The applicant may submit an amend- anniversary date of the application’s ment to an application that is pending, original approval or on a mutually including changes that may alter the agreed upon date. The report must in- conditions of use, the labeling, safety, clude minor manufacturing and control effectiveness, identity, strength, qual- changes made according to § 514.8(b)(4) ity, or purity of the drug or the ade- or state that no changes were made;

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

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conjugate of a drug substance with a (J) Any other information as directed monoclonal antibody for the following: by FDA. (1) Changes in the virus or adven- (iv) An applicant may ask FDA to ex- titious agent removal or inactivation pedite its review of a supplement for method(s), public health reasons or if a delay in (2) Changes in the source material or making the change described in it cell line, and would impose an extraordinary hard- (3) Establishment of a new master ship on the applicant. Such a supple- cell bank or seed; ment and its mailing cover must be (G) Changes to a drug under an appli- plainly marked: ‘‘Prior Approval Sup- cation that is subject to a validity as- plement-Expedited Review Requested.’’ sessment because of significant ques- (v) Comparability Protocols. An appli- tions regarding the integrity of the cant may submit one or more protocols data supporting that application. describing the specific tests and studies (iii) The applicant must obtain ap- and acceptance criteria to be achieved proval of a supplement from FDA prior to demonstrate the lack of adverse ef- to distribution of a drug made using a fect for specified types of manufac- change under paragraph (b)(2) of this turing changes on the identity, section. The supplement must be la- strength, quality, purity, and potency beled ‘‘Prior Approval Supplement.’’ of the drug as these factors may relate Except for submissions under para- to the safety or effectiveness of the graph (b)(2)(v) of this section, the fol- drug. Any such protocols, if not in- lowing information must be contained cluded in the approved application, or in the supplement: changes to an approved protocol, must (A) A completed Form FDA 356V; be submitted as a supplement requiring (B) A detailed description of the pro- approval from FDA prior to distribu- posed change; tion of the drug produced with the (C) The drug(s) involved; manufacturing change. The supple- (D) The manufacturing site(s) or ment, if approved, may subsequently area(s) affected; justify a reduced reporting category for (E) A description of the methods used the particular change because the use and studies performed to assess the ef- of the protocol for that type of change fects of the change; reduces the potential risk of an adverse (F) The data derived from such stud- effect. A comparability protocol sup- ies; plement must be labeled ‘‘Prior Ap- (G) Appropriate documentation (for proval Supplement—Comparability example, updated master batch Protocol.’’ records, specification sheets) including (3) Changes requiring submission of a previously approved documentation supplement at least 30 days prior to dis- (with the changes highlighted) or ref- tribution of the drug made using the erences to previously approved docu- change (moderate changes). (i) A supplementation; ment must be submitted for any (H) For a natural product, a recom- change in the drug, production process, binant DNA-derived protein/ quality controls, equipment, or facili- polypeptide, or a complex or conjugate ties that has a moderate potential to of a drug substance with a monoclonal have an adverse effect on the identity, antibody, relevant validation protocols strength, quality, purity, or potency of and standard operating procedures the drug as these factors may relate to must be provided in addition to the re- the safety or effectiveness of the drug. quirements in paragraphs (b)(2)(iii)(E) (ii) These changes include, but are and (b)(2)(iii)(F) of this section; not limited to: (I) For sterilization process and test (A) A change in the container closure methodologies related to sterilization system that does not affect the quality process validation, relevant validation of the drug except as otherwise de- protocols and a list of relevant stand- scribed in paragraphs (b)(2) and (b)(4) of ard operating procedures must be pro- this section; vided in addition to the requirements (B) Changes solely affecting a natural in paragraphs (b)(2)(iii)(E) and protein, a recombinant DNA-derived (b)(2)(iii)(F) of this section; and protein/polypeptide or a complex or

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

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solid dosage form drug product, with- mentation (with the changes high- out a change from one container clo- lighted) or references to previously ap- sure system to another; proved documentation; (E) A change within the container (I) Updated stability data generated closure system for a nonsterile drug on commercial or production batches product, based upon a showing of according to an approved stability pro- equivalency to the approved system tocol or commitment; and under a protocol approved in the appli- (J) Any other information as directed cation or published in an official com- by FDA. pendium; (c) Labeling and other changes to an (F) An extension of an expiration approved application—(1) General provi- dating period based upon full shelf-life sions. The applicant must notify FDA data on production batches obtained about each change in each condition from a protocol approved in the appli- established in an approved application cation; beyond the variations already provided (G) The addition or revision of an al- for in the application. The notice is re- ternative analytical procedure that quired to describe the change fully. provides the same or increased assur- (2) Labeling changes requiring the sub- ance of the identity, strength, quality, mission and approval of a supplement purity, or potency of the drug being prior to distribution of the drug made tested as the analytical procedure de- using the change (major changes). (i) Ad- scribed in the approved application, or dition of intended uses and changes to deletion of an alternative analytical package labeling require a supplement. procedure; and These changes include, but are not lim- (H) The addition by embossing, de- ited to: bossing, or engraving of a code imprint (A) Revision in labeling, such as up- to a solid oral dosage form drug prod- dating information pertaining to ef- uct other than a modified release dos- fects, dosages, adverse reactions, con- age form, or a minor change in an ex- traindications, which includes informa- isting code imprint. tion headed ‘‘adverse reactions,’’ (iii) For changes under this category, ‘‘warnings,’’ ‘‘precautions,’’ and ‘‘con- the applicant is required to submit in traindications,’’ except ones described the annual report: in (c)(3) of this section; (A) A completed Form FDA 356V; (B) Addition of an intended use; (B) A statement by the holder of the (C) If it is a prescription drug, any approved application that the effects of mailing or promotional piece used the change have been assessed; after the drug is placed on the market (C) A detailed description of the is labeling requiring a supplemental change(s); application, unless: (D) The manufacturing site(s) or (1) The parts of the labeling fur- area(s) involved; nishing directions, warnings, and infor- (E) The date each change was imple- mation for use of the drug are the same mented; in language and emphasis as labeling (F) Data from studies and tests per- approved or permitted; and formed to assess the effects of the (2) Any other parts of the labeling change; are consistent with and not contrary to (G) For a natural product, recom- such approved or permitted labeling. binant DNA-derived protein/ (3) Prescription drug labeling not re- polypeptide, complex or conjugate of a quiring an approved supplemental ap- drug substance with a monoclonal anti- plication is submitted in accordance body, sterilization process or test with § 514.80(b)(5)(ii). methodology related to sterilization (D) Any other changes in labeling, process validation, relevant validation except ones described in paragraph protocols and/or standard operating (c)(3) of this section. procedures; (ii) The applicant must obtain ap- (H) Appropriate documentation (for proval of the supplement from FDA example, updated master batch prior to distribution of the drug. The records, specification sheets, etc.) in- supplement must contain the fol- cluding previously approved docu- lowing:

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(A) A completed Form FDA 356V; FDA may initiate an enforcement ac- (B) A detailed description of the pro- tion because the drug is misbranded posed change; under section 502 of the act and/or (C) The drug(s) involved; adulterated under section 501 of the (D) The data derived from studies in act. In addition, under section 512(e) of support of the change; and the act, FDA may, after due notice and (E) Any other information as di- opportunity for a hearing, issue an rected by FDA. order withdrawing approval of the ap- (3) Labeling changes to be placed into plication. effect prior to receipt of a written notice (4) Changes providing for additional of approval of a supplemental application. distributors to be reported under Records (i) Labeling changes of the following and reports concerning experience with kinds that increase the assurance of approved new animal drugs (§ 514.80). drug safety proposed in supplemental Supplemental applications as described applications must be placed into effect under paragraph (c)(2) of this section immediately: will not be required for an additional (A) The addition to package labeling, distributor to distribute a drug that is promotional labeling, or prescription the subject of an approved new animal drug advertising of additional warning, drug application or abbreviated new contraindication, adverse reaction, and animal drug application if the condi- precaution information; tions described under § 514.80(b)(5)(iii) (B) The deletion from package label- are met. ing, promotional labeling, or drug ad- (d) Patent information. The applicant vertising of false, misleading, or unsup- must comply with the patent informa- ported intended uses or claims for ef- tion requirements under section fectiveness; and 512(c)(3) of the act. (C) Any other changes as directed by (e) Claimed exclusivity. If an applicant FDA. claims exclusivity under section (ii) Labeling changes (for example, 512(c)(2)(F) of the act upon approval of design and style) that do not decrease a supplemental application for a safety of drug use proposed in supple- change in its previously approved drug, mental applications may be placed into the applicant must include such a effect prior to written notice of ap- statement. proval from FDA of a supplemental ap- (f) Good laboratory practice for nonclin- plication. ical laboratory studies. A supplemental (iii) A supplement submitted under application that contains nonclinical paragraph (c)(3) of this section must in- laboratory studies must include, with clude the following information: respect to each nonclinical study, ei- (A) A full explanation of the basis for ther a statement that the study was the changes, the date on which such conducted in compliance with the re- changes are being effected, and plainly quirements set forth in part 58 of this marked on the mailing cover and on chapter, or, if the study was not con- the supplement, ‘‘Supplement—Label- ducted in compliance with such regula- ing Changes Being Effected’’; tions, a brief statement of the reason (B) Two sets of printed copies of any for the noncompliance. revised labeling to be placed in use, [71 FR 74782, Dec. 13, 2006] identified with the new animal drug application number; and § 514.11 Confidentiality of data and in- (C) A statement by the applicant formation in a new animal drug ap- that all promotional labeling and all plication file. drug advertising will promptly be re- (a) For purposes of this section the vised consistent with the changes made NADA file includes all data and infor- in the labeling on or within the new mation submitted with or incorporated animal drug package no later than by reference in the NADA, INAD’s in- upon approval of the supplemental ap- corporated into the NADA, supple- plication. mental NADA’s, reports under §§ 514.80 (iv) If the supplemental application and 510.301 of this chapter, master files, is not approved and the drug is being and other related submissions. The distributed with the proposed labeling, availability for public disclosure of any

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record in the NADA file shall be han- (b) Any inappropriate gratuitous dled in accordance with the provisions comments unnecessary to an objective of this section. analysis of the data and information. (b) The existence of an NADA file (ii) For an NADA approved after July will not be disclosed by the Food and 1, 1975, a summary of such data and in- Drug Administration before the appli- formation prepared in one of the fol- cation has been approved, unless it has lowing two alternative ways shall be been previously disclosed or acknowl- publicly released when the application edged. is approved. (c) If the existence of an NADA file (a) The Center for Veterinary Medi- has not been publicly disclosed or ac- cine may at an appropriate time prior knowledged, no data or information in to approval of the NADA require the the NADA file is available for public applicant to prepare a summary of disclosure. such data and information, which will (d) If the existence of an NADA file be reviewed and, where appropriate, re- has been publicly disclosed or acknowl- vised by the Center. edged before the application has been (b) The Center for Veterinary Medi- approved, no data or information con- cine may prepare its own summary of tained in the file is available for public such data and information. disclosure, but the Commissioner may, (3) A protocol for a test or study, un- in his discretion, disclose a summary of less it is shown to fall within the ex- such selected portions of the safety and emption established for trade secrets effectiveness data as are appropriate and confidential commercial informa- for public consideration of a specific tion in § 20.61 of this chapter. pending issue, i.e., at an open session of (4) Adverse reaction reports, product a Food and Drug Administration advi- experience reports, consumer com- sory committee or pursuant to an ex- plaints, and other similar data and in- change of important regulatory infor- formation, after deletion of: mation with a foreign government. (i) Names and any information that (e) After an application has been ap- would identify the person using the proved, the following data and informa- product. tion in the NADA file are immediately (ii) Names and any information that available for public disclosure unless would identify any third party involved extraordinary circumstances are with the report, such as a physician, shown: hospital, or other institution. (1) All safety and effectiveness data (5) A list of all active ingredients and and information previously disclosed to any inactive ingredients previously the public, as defined in § 20.81 of this disclosed to the public as defined in chapter. § 20.81 of this chapter. (2) A summary or summaries of the (6) An assay method or other analyt- safety and effectiveness data and infor- ical method, unless it serves no regu- mation submitted with or incorporated latory or compliance purpose and is by reference in the NADA file. Such shown to fall within the exemption es- summaries do not constitute the full tablished in § 20.61 of this chapter. reports of investigations under section (7) All correspondence and written 512(b)(1) of the act (21 U.S.C. 360b(b)(1)) summaries of oral discussions relating on which the safety or effectiveness of to the NADA, in accordance with the the drug may be approved. Such sum- provisions of part 20 of this chapter. maries shall consist of the following: (f) All safety and effectiveness data (i) For an NADA approved prior to and information not previously dis- July 1, 1975, internal agency records closed to the public are available for that describe such data and informa- public disclosure at the time any one of tion, e.g., a summary of basis for ap- the following events occurs unless ex- proval or internal reviews of the data traordinary circumstances are known: and information, after deletion of: (1) The NADA has been abandoned (a) Names and any information that and no further work is being under- would identify the investigators. taken with respect to it.

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(2) A final determination is made (b) The availability for public disclo- that the NADA is not approvable, and sure of all data and information in an all legal appeals have been exhausted. INAD file shall be handled in accord- (3) Approval of the NADA is with- ance with provisions established in drawn, and all legal appeals have been § 514.11. exhausted. (4) A final determination has been § 514.15 Untrue statements in applications. made that the animal drug is not a new animal drug. Among the reasons why an applica- (5) A final determination has been tion for a new animal drug or animal made that the animal drug may be feed bearing or containing a new ani- marketed without submission of such mal drug may contain an untrue state- safety and/or effectiveness data and in- ment of a material fact are: formation. (a) Differences in: (g) The following data and informa- (1) Conditions of use prescribed, rection in an NADA file are not available ommended, or suggested by the appli- for public disclosure unless they have cant for the product from the condi- been previously disclosed to the public tions of such use stated in the applica- as defined in § 20.81 of this chapter or tion; they relate to a product or ingredient (2) Articles used as components of that has been abandoned and they no the product from those listed in the ap- longer represent a trade secret or con- plication; fidential commercial or financial infor- (3) Composition of the product from mation as defined in § 20.61 of this chap- that stated in the application; ter: (4) Methods used in or the facilities and controls used for the manufacture, (1) Manufacturing methods or proc- processing, or packing of the product esses, including quality control proce- from such methods, facilities, and con- dures. trols described in the application; (2) Production, sales, distribution, (5) Labeling from the specimens con- and similar data and information, ex- tained in the application; or cept that any compilation of such data (b) The unexplained omission in and information aggregated and pre- whole or in part from an application or pared in a way that does not reveal from an amendment or supplement to data or information which is not avail- an application or from any record or able for public disclosure under this report required under the provisions of provision is available for public disclo- section 512 of the act and § 514.80 or sure. § 510.301 of this chapter of any informa- (3) Quantitative or semiquantitative tion obtained from: formulas. (1) Investigations as to the safety, ef- (h) For purposes of this regulation, fectiveness, identity, strength, quality, safety and effectiveness data include or purity of the drug, made by the ap- all studies and tests of an animal drug plicant on the drug, or on animals and all studies and tests on (2) Investigations or experience with the animal drug for identity, stability, the product that is the subject of the purity, potency, and bioavailability. application, or any related product, [40 FR 13825, Mar. 27, 1975, as amended at 42 available to the applicant from any FR 3109, Jan. 14, 1977; 42 FR 15675, Mar. 22, source if such information is pertinent 1977; 54 FR 18280, Apr. 28, 1989; 68 FR 15365, to an evaluation of the safety, effec- Mar. 31, 2003; 79 FR 14611, Mar. 17, 2014] tiveness, identity, strength, quality, or purity of the drug, when such omission § 514.12 Confidentiality of data and in- would bias an evaluation of the safety formation in an investigational new or effectiveness of the product. animal drug notice. (c) Any nonclinical laboratory study (a) The existence of an INAD notice contained in the application was not will not be disclosed by the Food and conducted in compliance with the good Drug Administration unless it has pre- laboratory practice regulations as set viously been publicly disclosed or ac- forth in part 58 of this chapter, and the knowledged. application fails to include a brief

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statement of the reason for the non- Subpart B—Administrative Actions compliance. on Applications [40 FR 13825, Mar. 27, 1975, as amended at 49 FR 7226, Feb. 28, 1984; 50 FR 7517, Feb. 22, 1985; 68 FR 15365, Mar. 31, 2003]

§ 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?

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Purpose 21 CFR Paragraph and Title

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

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

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

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

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

514.80(b)(5) Other reporting.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 drug that has not been previously sub- must establish and maintain indexed mitted as part of the NADA or ANADA. and complete files containing full Such records must include information records of all information pertinent to from domestic as well as foreign safety or effectiveness of a new animal

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sources. Each nonapplicant must estab- tially may be provided by telephone or lish and maintain indexed and com- other telecommunication means, with plete files containing full records of all prompt written followup using Form information pertinent to safety or ef- FDA 1932 ‘‘Veterinary Adverse Drug fectiveness of a new animal drug that Reaction, Lack of Effectiveness, Prod- is received or otherwise obtained by uct Defect Report.’’ The mailing cover the nonapplicant. Such records must for these reports must be plainly include information from domestic as marked ‘‘3-Day NADA/ANADA Field well as foreign sources. Alert Report.’’ (2) Each applicant must submit re- (2) Fifteen-day NADA/ANADA alert reports of data, studies, and other infor- port—(i) Initial report. This report pro- mation concerning experience with vides information on each serious, un- new animal drugs to the Food and Drug expected adverse drug event, regardless 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 this section from domestic, as well as drug events that are the subject of 15- foreign sources. day NADA/ANADA alert reports. If this (3) FDA reviews the records and re- investigation reveals significant new ports required in this section to facili- information, a followup report must be tate a determination under section submitted within 15 working days of 512(e) of the Federal Food, Drug, and receiving such information. A followup Cosmetic Act (21 U.S.C. 360b(e)) as to report must be submitted on Form whether there may be grounds for sus- FDA 1932, and its mailing cover must pending or withdrawing approval of the be plainly marked ‘‘15-Day NADA/ NADA or ANADA. ANADA Alert Report Followup.’’ The (4) The requirements of this section followup report must state the date of also apply to any approved Type A the initial report and provide the addi- medicated article. In addition, the re- tional information. If additional infor- quirements contained in § 514.80(b)(1), mation is sought but not obtained (b)(2), (b)(4)(iv), and (b)(4)(v) apply to within 3 months of the initial report, a any approved Type A medicated article followup report is required describing incorporated in animal feeds. the steps taken and why additional in- (5) The records and reports referred formation was not obtained. 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

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also report directly to FDA, the non- (1) Applicants must have submitted applicant should submit the report on complete periodic drug experience re- Form FDA 1932 within 15 working days ports under this section for such appli- of first receiving the information. cations for at least 2 full years after (4) Periodic drug experience report. the date of their initial approval. This report must be accompanied by a (2) Applicants must ensure that the completed Form FDA 2301 ‘‘Trans- beginning of the reporting period for mittal of Periodic Reports and Pro- the annual periodic drug experience re- motional Materials for New Animal ports for such applications is January Drugs.’’ It must be submitted every 6 1. For applications that currently have months for the first 2 years following a reporting period that begins on a approval of an NADA or ANADA and date other than January 1, applicants yearly thereafter. Reports required by must request a change in reporting this section must contain data and in- submission date such that the report- formation for the full reporting period. ing period begins on January 1 and The 6-month periodic drug experience ends on December 31, as described in reports must be submitted within 30 paragraph (b)(4) of this section. days following the end of the 6-month (3) Applicants that change their re- reporting period. The yearly periodic porting submission date must also sub- drug experience reports must be submit a special drug experience report, as mitted within 90 days of the anniver- described in paragraph (b)(5)(i) of this sary date of the approval of the NADA section, that addresses any gaps in distribution data caused by the change in or ANADA. Any previously submitted date of submission. information contained in the report (4) Applicants who choose not to re- must be identified as such. For yearly port under paragraph (b)(4)(i)(A) of this (annual) periodic drug experience re- section must ensure that full sales and ports, the applicant may petition FDA distribution data for each product ap- to change the date of submission or fre- proved under such applications are al- quency of reporting, and after approval ternatively reported under § 514.87, in- of such petition, file such reports on cluding products that are labeled for the new filing date or at the new re- use only in nonfood-producing animals. porting frequency. Also, FDA may re- (ii) Labeling. Applicant and dis- quire a report at different times or tributor current package labeling, in- more frequently. The periodic drug excluding package inserts (if any). For perience report must contain the fol- large-size package labeling or large lowing: shipping cartons, a representative copy (i) Distribution data. (A) Information must be submitted (e.g., a photocopy of about the distribution of each new ani- pertinent areas of large feed bags). A mal drug product, including informa- summary of any changes in labeling tion on any distributor-labeled prod- made since the last report (listed by uct. This information must include the date of implementation) must be in- total number of distributed units of cluded with the labeling or if there each size, strength, or potency (e.g., have been no changes, a statement of 100,000 bottles of 100 5-milligram tab- such fact must be included with the la- lets; 50,000 10-milliliter vials of 5-per- beling. cent solution). This information must (iii) Nonclinical laboratory studies be presented in two categories: Quan- and clinical data not previously re- tities distributed domestically and ported. quantities exported. (A) Copies of in vitro studies (e.g., (B) Applicants submitting annual mutagenicity) and other nonclinical sales and distribution reports for anti- laboratory studies conducted by or oth- microbial new animal drug products erwise obtained by the applicant. under § 514.87 have the option not to re- (B) Copies of published clinical trials port distribution data under paragraph of the new animal drug (or abstracts of (b)(4)(i)(A) of this section for the ap- them) including clinical trials on safe- proved applications that include these ty and effectiveness, clinical trials on same products, but only provided each new uses, and reports of clinical experi- of the following conditions are met: ence pertinent to safety conducted by

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or otherwise obtained by the applicant. interpretation of the results. The sum- Review articles, papers, and abstracts maries must be submitted in a separate in which the drug is used as a research section within the periodic drug experi- tool, promotional articles, press clip- ence report. pings, and papers that do not contain (5) Other reporting—(i) Special drug ex- tabulations or summaries of original perience report. Upon written request, data are not required to be reported. FDA may require that the applicant (C) Descriptions of completed clinical submit a report required under § 514.80 trials conducted by or for the applicant at different times or more frequently must be submitted no later than 1 year than the timeframes stated in § 514.80. after completion of research. Sup- (ii) Advertisements and promotional la- porting information is not to be re- beling. The applicant must submit at ported. the time of initial dissemination one (iv) Adverse drug experiences. (A) set of specimens of mailing pieces and Product/manufacturing defects and adverse drug experiences not previously other labeling for prescription and reported under § 514.80(b)(1) and (b)(2) over-the-counter new animal drugs. must be reported individually on Form For prescription new animal drugs, the FDA 1932. applicant must also submit one set of (B) Reports of adverse drug experi- specimens of any advertisement at the ences in the literature must be noted time of initial publication or broad- in the periodic drug experience report. cast. Mailing pieces and labeling de- A bibliography of pertinent references signed to contain product samples must be included with the report. Upon must be complete except that product FDA’s request, the applicant must pro- samples may be omitted. Each submis- vide a full text copy of these publica- sion of promotional labeling or adver- tions. tisements must be accompanied by a (C) Reports of previously not re- completed Form FDA 2301. ported adverse drug experiences that (iii) Distributor’s statement. At the occur in postapproval studies must be time of initial distribution of a new reported separately from other experi- animal drug product by a distributor, ences in the periodic drug experience the applicant must submit a special report and clearly marked or high- drug experience report accompanied by lighted. a completed Form FDA 2301 containing (v) Summary report of increased fre- the following: quency of adverse drug experience. The (A) The distributor’s current product applicant must periodically review the labeling. incidence of reports of adverse drug ex- (1) The distributor’s labeling must be periences to determine if there has identical to that in the approved been an increased frequency of serious NADA/ANADA except for a different (expected and unexpected) adverse drug and suitable proprietary name (if used) events. The applicant must evaluate and the name and address of the dis- the increased frequency of serious (ex- tributor. The name and address of the pected or unexpected) adverse drug distributor must be preceded by an ap- events at least as often as reporting of propriate qualifying phrase as per- periodic drug experience reports. The mitted by the regulations such as applicant must report the increased ‘‘manufactured for’’ or ‘‘distributed frequency of serious (expected and un- by.’’ expected) adverse drug events in the periodic drug experience report. Sum- (2) Other labeling changes must be maries of reports of increased fre- the subject of a supplemental NADA or quency of adverse drug events must be ANADA as described under § 514.8. submitted in narrative form. The sum- (B) A signed statement by the dis- maries must state the time period on tributor stating: which the increased frequency is based, (1) The category of the distributor’s time period comparisons in deter- operations (e.g., wholesale or retail), mining increased frequency, references (2) That the distributor will dis- to any previously submitted Form FDA tribute the new animal drug only under 1932, the method of analysis, and the the approved labeling,

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

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whether to withdraw approval of the the United States (i.e., quantities ex- application. ported) for each month of the reporting (i) Disclaimer. Any report or informa- year. tion submitted under this section and (c) Each report must also provide a any release of that report or informa- species-specific estimate of the per- tion by FDA will be without prejudice centage of each product described in and does not necessarily reflect a con- paragraph (b)(2) of this section that clusion that the report or information was sold or distributed domestically in constitutes an admission that the drug the reporting year for use in any of the caused or contributed to an adverse following animal species categories, event. A person need not admit, and but only for such species that appear may deny, that the report or informa- on the approved label: Cattle, swine, tion constitutes an admission that a chickens, turkeys. The total of the spe- drug caused or contributed to an ad- cies-specific percentages reported for verse event. each product must account for 100 per- [68 FR 15365, Mar. 31, 2003, as amended at 81 cent of its sales and distribution; FR 29141, May 11, 2016] therefore, a fifth category of ‘‘other species/unknown’’ must also be re- § 514.87 Annual reports for anti- ported. microbial animal drug sales and (d) Each report must: distribution. (1) Be submitted not later than (a) The applicant for each new ani- March 31 each year; mal drug product approved under sec- (2) Cover the period of the preceding tion 512 of the Federal Food, Drug, and calendar year; and Cosmetic Act, or conditionally ap- (3) Be submitted using Form FDA proved under section 571 of the Federal 3744, ‘‘Antimicrobial Animal Drug Dis- Food, Drug, and Cosmetic Act, and tribution Report.’’ containing an antimicrobial active in- (e) Sales and distribution data and gredient, must submit an annual report information reported under this sec- to FDA on the amount of each such tion will be considered to fall within antimicrobial active ingredient in the the exemption for confidential com- drug that is sold or distributed in the mercial information established in reporting year for use in food-pro- § 20.61 of this chapter and will not be ducing animal species, including infor- publicly disclosed, except that sum- mation on any distributor-labeled mary reports of such information ag- product. gregated in such a way that does not (b) This report must identify the ap- reveal information that is not avail- proved or conditionally approved appli- able for public disclosure under this cation and must include the following provision will be prepared by FDA and information for each new animal drug made available to the public as pro- product described in paragraph (a) of vided in paragraph (f) of this section. this section: (f) FDA will publish an annual sum- (1) A listing of each antimicrobial ac- mary report of the data and informative ingredient contained in the prod- tion it receives under this section for uct; each calendar year by December 31 of (2) A description of each product sold the following year. Such annual re- or distributed by unit, including the ports must include a summary of sales container size, strength, and dosage and distribution data and information form of such product units; by antimicrobial drug class and may (3) For each such product, a listing of include additional summary data and the target animal species, indications, information as determined by FDA. In and production classes that are speci- order to protect confidential commer- fied on the approved label; cial information, each individual (4) For each such product, the num- datum appearing in the summary re- ber of units sold or distributed in the port must: United States (i.e., domestic sales) for (1) Reflect combined product sales each month of the reporting year; and and distribution data and information (5) For each such product, the num- obtained from three or more distinct ber of units sold or distributed outside sponsors of approved products that

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were actively sold or distributed that professional use including indications, reporting year, and effects, dosages, routes, methods, and (2) Be reported in a manner con- frequency and duration of administra- sistent with protecting both national tion and any relevant hazards, contra- security and confidential commercial indications, side effects, and pre- information. cautions under which practitioners li- [81 FR 29141, May 11, 2016] censed by law to administer such drug can use the drug for the purposes for § 514.100 Evaluation and comment on which it is intended, including all pur- applications. poses for which it is to be advertised, (a) After the filed application has or represented, in accordance with been evaluated, the applicant will be § 201.105 of this chapter, and informa- furnished written comment on any ap- tion concerning hazards, contraindica- parent deficiencies in the application. tions, side effects, and precautions rel- (b) When the description of the meth- evant with respect to any uses for ods used in, and the facilities and con- which such drug is to be prescribed. trols used for, the manufacture, proc- (2) The application fails to show that essing, and packing of such new animal the labeling and advertising of such drug appears adequate on its face, but drug will offer the drug for use only it is not feasible to reach a conclusion under those conditions for which it is as to the safety and effectiveness of the offered in the labeling that is part of new animal drug solely from consider- the application. ation of this description, the applicant (3) The application fails to show that may be notified that an establishment all labeling that furnishes or purports inspection is required to verify their to furnish information for professional adequacy. use of such drug will contain, in the (c) A request for samples of a new same language and emphasis, the infor- animal drug or any edible tissues and mation for use including indications, byproducts of animals treated with effects, dosages, routes, methods, and such a drug, shall specify the quantity frequency and duration of administra- deemed adequate to permit tests of an- tion and any relevant warnings, haz- alytical methods to determine their ards, contraindications, side effects, adequacy for regulatory purposes. The and precautions, which is contained in request should be made as early in the the labeling that is part of the applica- 180-day period as possible to assure tion in accordance with § 201.105 of this timely completion. The date used for chapter. computing the 180-day limit for the purposes of section 512(c) of the act (e) The information contained in an shall be moved forward 1 day for each application will be considered insuffi- day after the mailing date of the re- cient to determine whether a new ani- quest until all of the requested samples mal drug is safe and effective for use are received. If the samples are not re- when there is a refusal or failure upon ceived within 90 days after the request, written notice to furnish inspectors au- the application will be considered with- thorized by the Food and Drug Admin- drawn without prejudice. istration an adequate opportunity to (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

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

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(viii) A change in the prescription or (3) It is incomplete on its face in that over-the-counter status of a drug prod- it is not properly organized and in- uct. dexed. (ix) A change in statements regard- (4) On its face the information con- ing side effects, warnings, precautions, cerning required matter is so inad- and contraindications, except the addi- equate that the application is clearly tion of approved statements to con- not approvable. tainer, package, and promotional label- (5) The new animal drug is to be man- ing, and prescription drug advertising. ufactured, prepared, propagated, com- (x) A change in the drug withdrawal pounded, or processed in whole or in period prior to slaughter or in the milk part in any State in an establishment discard time. that has not been registered or exempted from registration under the provi- (xi) A change in the tolerance for sions of section 510 of the act. drug residues. (6) The sponsor does not reside or (xii) A change in analytical methods maintain a place of business within the for drug residues. United States and the application has (xiii) A revised method of synthesis not been countersigned by an attorney, or fermentation of the new drug sub- agent, or other representative of the stance. applicant, which representative resides (xiv) Updating or changes in the in the United States and has been duly manufacturing process of the new drug authorized to act on behalf of the ap- substance and/or final dosage form plicant and to receive communications (other than a change in equipment that on all matters pertaining to the appli- does not alter the method of manufac- cation. ture of a new animal drug, or a change (7) The new animal drug is a drug from one commercial batch size to an- subject to licensing under the animal other without any change in manufac- virus, serum, and toxin law of March 4, turing procedure), or changes in the 1913 (37 Stat. 832; 21 U.S.C. 151 et seq. ). methods, facilities, or controls used for Such applications will be referred to the manufacture, processing, pack- the U.S. Department of Agriculture for aging, or holding of the new animal action. drug (other than use of an establish- (8) It fails to include, with respect to ment not covered by the approval that each nonclinical laboratory study con- is in effect) that give increased assur- tained in the application, either a ance that the drug will have the char- statement that the study was con- acteristics of identity, strength, qual- ducted in compliance with the good ity, and purity which it purports or is laboratory practice regulations set represented to possess. forth in part 58 of this chapter, or, if the study was not conducted in compli- [55 FR 46052, Nov. 1, 1990; 55 FR 49973, Dec. 3, ance with such regulations, a brief 1990; 56 FR 12422, Mar. 25, 1991; 71 FR 74785, statement of the reasons for the non- Dec. 13, 2006] compliance. § 514.110 Reasons for refusing to file (9) [Reserved] applications. (10) The applicant fails to submit a 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

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request that the application be filed (iii) Safety factors which, in the over protest, in which case it will be opinion of experts qualified by sci- filed as of the day originally received. entific training and experience to evaluate the safety of such drugs, are [40 FR 13825, Mar. 27, 1975, as amended at 50 FR 7517, Feb. 22, 1985; 50 FR 16668, Apr. 26, appropriate for the use of animal ex- 1985; 62 FR 40600, July 29, 1997] perimentation data; and (iv) Whether the conditions of use § 514.111 Refusal to approve an appli- prescribed, recommended, or suggested cation. in the proposed labeling are reasonably (a) The Commissioner shall, within certain to be followed in practice; or 180 days after the filing of the applica- (5) Evaluated on the basis of information, inform the applicant in writing of tion submitted as part of the applica- his intention to issue a notice of oppor- tion and any other information before tunity for a hearing on a proposal to the Food and Drug Administration refuse to approve the application, if the with respect to such drug, there is lack Commissioner determines upon the of substantial evidence as defined in basis of the application, or upon the § 514.4. basis of other information before him (6) Failure to include an appropriate with respect to a new animal drug, proposed tolerance for residues in edi- that: ble products derived from animals or a (1) The reports of investigations re- withdrawal period or other restrictions quired to be submitted pursuant to sec- for use of such drug if any tolerance or tion 512(b) of the act do not include withdrawal period or other restrictions adequate tests by all methods reason- for use are required in order to assure ably applicable to show whether or not that the edible products derived from such drug is safe for use under the con- animals treated with such drug will be ditions prescribed, recommended, or safe. suggested in the proposed labeling (7) Based on a fair evaluation of all thereof; or material facts, the labeling is false or (2) The results of such tests show misleading in any particular; or that such drug is unsafe for use under such conditions or do not show that (8) Such drug induces cancer when in- such drug is safe for use under such gested by man or animal or, after ap- conditions; or propriate tests for evaluation of the safety of such drug, induces cancer in (3) The methods used in and the facilities and controls used for the manu- man or animal, except that this sub- facture, processing, and packing of paragraph shall not apply with respect such drug are inadequate to preserve to such drug if the Commissioner finds its identity, strength, quality, and pu- that, under the conditions of use speci- rity; or fied in proposed labeling and reason- (4) Upon the basis of the information ably certain to be followed in practice: submitted to the Food and Drug Ad- (i) Such drug will not adversely af- ministration as part of the application, fect the animal for which it is in- or upon the basis of any other informa- tended; and tion before it with respect to such (ii) No residue of such drug will be drug, it has insufficient information to found (by methods of examination pre- determine whether such drug is safe for scribed or approved by the Commis- use under such conditions. In making sioner by regulations) in any edible this determination the Commissioner portion of such animal after slaughter shall consider, among other relevant or in any food yielded by, or derived factors: from the living animals. (i) The probable consumption of such (9) The applicant fails to submit an drug and of any substance formed in or adequate environmental assessment on food because of the use of such drug; under § 25.40 of this chapter or fails to (ii) The cumulative effect on man or provide sufficient information to estab- animal of such drug, taking into ac- lish that the requested action is sub- count any chemically or pharmacologi- ject to categorical exclusion under cally related substances; § 25.30 or § 25.33 of this chapter.

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

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(4) That any nonclinical laboratory withdrawn on the basis of a request for study that is described in the applica- its withdrawal submitted in writing by tion and that is essential to show that a person holding an approved new ani- the drug is safe for use under the condi- mal drug application on the grounds tions prescribed, recommended, or sug- that the drug subject to such applica- gested in its proposed labeling, was not tion is no longer being marketed and conducted in compliance with the good information is included in support of laboratory practice regulations as set this finding, provided none of the con- forth in part 58 of this chapter and no ditions cited in paragraphs (a), (b), and reason for the noncompliance is pro- (c) of this section pertain to the sub- vided or, if it is, the differences be- ject drug. A written request for such tween the practices used in conducting withdrawal shall be construed as a the study and the good laboratory waiver of the opportunity for a hearing practice regulations do not support the as otherwise provided for in this sec- validity of the study. tion. Withdrawal of approval of an ap- (c) The Commissioner may notify in plication under the provisions of this writing the person holding an applica- paragraph shall be without prejudice. tion approved pursuant to section (e) On the basis of the withdrawal of 512(c) of the act and afford an oppor- approval of an application for a new tunity for a hearing on a proposal to animal drug approved pursuant to sec- withdraw approval of such application tion 512(c) of the act, the regulation if he finds: published pursuant to section 512(i) of (1) That the applicant has failed to the act covering the conditions of use establish a system for maintaining re- of such drug as provided for in the ap- quired records, or has repeatedly or de- plication shall be revoked. liberately failed to maintain such [40 FR 13825, Mar. 27, 1975, as amended at 50 records or to make required reports in FR 7517, Feb. 22, 1985; 64 FR 63204, Nov. 19, accordance with a regulation or order 1999] under section 512(l)(1) of the act, or the applicant has refused to permit access § 514.116 Notice of withdrawal of ap- to, or copying, or verification of, such proval of application. records as required by section 512(l)(2) When an approval of an application of the act; or submitted pursuant to section 512 of (2) That on the basis of new informa- the act is withdrawn by the Commis- tion before him evaluated together sioner, he will give appropriate public with the evidence before him when the notice of such action by publication in application was approved, the methods the FEDERAL REGISTER. used in, or the facilities and controls used for, the manufacture, processing, § 514.117 Adequate and well-controlled and packing of such drug or animal studies. feed are inadequate to assure and pre- (a) Purpose. The primary purpose of serve its identity, strength, quality, conducting adequate and well-con- and purity and were not made adequate trolled studies of a new animal drug is within a reasonable time after receipt to distinguish the effect of the new ani- of written notice from the Secretary mal drug from other influences, such as specifying the matter complained of; or spontaneous change in the course of (3) That on the basis of new informa- the disease, normal animal production tion before him, evaluated together performance, or biased observation. with the evidence before him when the One or more adequate and well-con- 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

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an important aspect of adequacy. The which can be correlated with the spe- Food and Drug Administration (FDA) cific formulation and production proc- considers these characteristics in de- ess used to manufacture the new ani- termining whether a study is adequate mal drug used in the study. and well controlled for purposes of sec- (4) The study uses a design that per- tion 512 of the Federal Food, Drug, and mits a valid comparison with one or Cosmetic Act (the act) (21 U.S.C. 360b). more controls to provide a quantitative Adequate and well-controlled studies, evaluation of drug effects. The protocol in addition to providing a basis for de- and the study report must describe the termining whether a new animal drug precise nature of the study design, e.g., is effective, may also be relied upon to duration of treatment periods, whether support target animal safety. The re- treatments are parallel, sequential, or port of an adequate and well-controlled crossover, and the determination of study should provide sufficient details sample size. Within the broad range of of study design, conduct, and analysis studies conducted to support a deter- to allow critical evaluation and a determination of whether the character- mination of the effectiveness of a new istics of an adequate and well-con- animal drug, certain of the controls trolled study are present. listed below would be appropriate and (b) Characteristics. An adequate and preferred depending on the study con- well-controlled study has the following ducted: characteristics: (i) Placebo concurrent control. The new (1) The protocol for the study (pro- animal drug is compared with an inac- tocol) and the report of the study re- tive preparation designed to resemble sults (study report) must include a the new animal drug as far as possible. clear statement of the study objec- (ii) Untreated concurrent control. The tive(s). new animal drug is compared with the (2) The study is conducted in accord- absence of any treatment. The use of ance with an appropriate standard of this control may be appropriate when conduct that addresses, among other objective measurements of effective- issues, study conduct, study personnel, ness, not subject to observer bias, are study facilities, and study documenta- available. tion. The protocol contains a state- (iii) Active treatment concurrent con- ment acknowledging the applicability trol. The new animal drug is compared of, and intention to follow, a standard with known effective therapy. The use of conduct acceptable to FDA. The of this control is appropriate when the study report contains a statement de- use of a placebo control or of an un- scribing adherence to the standard. treated concurrent control would un- (3) The study is conducted with a new reasonably compromise the welfare of animal drug that is produced in accord- the animals. Similarity of the new ani- ance with appropriate manufacturing mal drug and the active control drug practices, which include, but are not necessarily limited to, the manufac- can mean either that both drugs were ture, processing, packaging, holding, effective or that neither was effective. and labeling of the new animal drug The study report should assess the such that the critical characteristics of ability of the study to have detected a identity, strength, quality, purity, and difference between treatments. The physical form of the new animal drug evaluation of the study should explain are known, recorded, and reproducible, why the new animal drugs should be to permit meaningful evaluations of considered effective in the study, for and comparisons with other studies example, by reference to results in pre- conducted with the new animal drug. vious placebo-controlled studies of the The physical form of a new animal active control. drug includes the formulation and (iv) Historical control. The results of physical characterization (including treatment with the new animal drug delivery systems thereof, if any) of the are quantitatively compared with expe- new animal drug as presented to the rience historically derived from the animal. The protocol and study report adequately documented natural history must include an identification number of the disease or condition, or with a

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regimen (therapeutic, diagnostic, pro- control using the controls set forth in phylactic) whose effectiveness is estab- paragraph (b)(4) of this section. lished, in comparable animals. Because (7) The study uses methods to mini- historical control populations usually mize bias on the part of observers and cannot be as well assessed with respect analysts of the data that are adequate to pertinent variables as can concur- to prevent undue influences on the re- rent control populations, historical sults and interpretation of the study control designs are usually reserved for data. The protocol and study report ex- special circumstances. Examples in- plain the methods of observation and clude studies in which the effect of the recording of the animal response vari- new animal drug is self-evident or stud- ables and document the methods, such ies of diseases with high and predict- as ‘‘blinding’’ or ‘‘masking,’’ used in able mortality, or signs and symptoms the study for excluding or minimizing of predictable duration or severity, or, bias in the observations. in the case of prophylaxis, predictable (8) The study uses methods to assess morbidity. animal response that are well defined (5) The study uses a method of select- and reliable. The protocol and study re- ing animals that provides adequate as- port describe the methods for con- surances that the animals are suitable ducting the study, including any appro- for the purposes of the study. For ex- priate analytical and statistical meth- ample, the animals can reasonably be ods, used to collect and analyze the expected to have animal production data resulting from the conduct of the characteristics typical of the class(es) study, describe the criteria used to as- of animals for which the new animal sess response, and, when appropriate, drug is intended, there is adequate as- justify the selection of the methods to surance that the animals have the dis- assess animal response. ease or condition being studied, or, in (9) There is an analysis and evalua- the case of prophylactic agents, evi- tion of the results of the study in ac- dence of susceptibility and exposure to cord with the protocol adequate to as- the condition against which prophy- sess the effects of the new animal drug. laxis is desired has been provided. The The study report evaluates the meth- protocol and the study report describe ods used to conduct, and presents and the method of selecting animals for the evaluates the results of, the study as to study. their adequacy to assess the effects of (6) The study uses a method to assign the new animal drug. This evaluation a treatment or a control to each exper- of the results of the study assesses, imental unit of animals that is random among other items, the comparability and minimizes bias. Experimental of treatment and control groups with units of animals are groups of animals respect to pertinent variables and the that are comparable with respect to effects of any interim analyses per- pertinent variables such as age, sex, formed. class of animal, severity of disease, du- (c) Field studies. (1) Field conditions ration of disease, dietary regimen, as used in this section refers to condi- level of animal production, and use of tions which closely approximate the drugs or therapy other than the new conditions under which the new animal animal drug. The protocol and the drug, if approved, is intended to be ap- study report describe the method of as- plied or administered. signment of animals to an experi- (2) Studies of a new animal drug con- mental unit to account for pertinent ducted under field conditions shall, variables and method of assignment of consistent with generally recognized a treatment or a control to the experi- scientific principles and procedures, mental units. When the effect of such use an appropriate control that per- variables is accounted for by an appro- mits comparison, employ procedures to priate design, and when, within the minimize bias, and have the character- same animal, effects due to the test istics generally described in paragraph drug can be obtained free of the effects (b) of this section. However, because of such variables, the same animal may field studies are conducted under field be used for both the test drug and the conditions, it is recognized that the

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level of control over some study condi- § 514.120 Revocation of order refusing tions need not or should not be the to approve an application or sus- same as the level of control in labora- pending or withdrawing approval tory studies. While not all conditions of an application. relating to a field study need to be or The Commissioner, upon his own ini- should be controlled, observations of tiative or upon request of an applicant the conditions under which the new stating reasonable grounds therefor animal drug is tested shall be recorded and if he finds that the facts so require, in sufficient detail to permit evalua- may issue an order approving an appli- tion of the study. Adequate and well- cation that previously has had its ap- controlled field studies shall balance proval refused, suspended, or with- the need to control study conditions drawn. with the need to observe the true effect § 514.121 Service of notices and orders. of the new animal drug under closely All notices and orders under this sub- approximated actual use conditions. chapter E and section 512 of the act (d) The Director of the Center Waiver. pertaining to new animal drug applica- for Veterinary Medicine (the Director) tions shall be served: may, on the Director’s own initiative (a) In person by any officer or em- or on the petition of an interested per- ployee of the Department designated son, waive in whole or in part any of by the Commissioner; or the criteria in paragraph (b) of this sec- (b) By mailing the order by certified tion with respect to a specific study. A mail addressed to the applicant or re- petition for a waiver is required to set spondent at his last known address in forth clearly and concisely the specific the records of the Food and Drug Ad- criteria from which waiver is sought, ministration. why the criteria are not reasonably applicable to the particular study, what Subpart C—Hearing Procedures alternative procedures, if any, are to be, or have been employed, and what § 514.200 Notice of opportunity for results have been obtained. The peti- hearing; notice of participation and requests for hearing; grant or de- tion is also required to state why the nial of hearing. studies so conducted will yield, or have yielded, substantial evidence of effec- (a) The notice to the applicant of opportunity for a hearing on a proposal tiveness, notwithstanding nonconform- by the Commissioner to refuse to ap- ance with the criteria for which waiver prove an application or to withdraw is requested. the approval of an application will be (e) Uncontrolled studies. Uncontrolled published in the FEDERAL REGISTER to- studies or partially controlled studies gether with an explanation of the are not acceptable as the sole basis for grounds for the proposed action. The the approval of claims of effectiveness notice will describe how to request a or target animal safety. Such studies, hearing. An applicant has 30 days after carefully conducted and documented, publication of the notice to request a may provide corroborative support of hearing. adequate and well-controlled studies (b) If the applicant fails to request a regarding effectiveness and may yield hearing within the 30-day timeframe, valuable data regarding safety of the the Commissioner, without further no- new animal drug. Such studies will be tice, will publish a final order denying considered on their merits in light of or withdrawing approval of the applica- the characteristics listed here. Isolated tion. case reports, random experience, and (c) If the applicant desires to request reports lacking the details which per- a hearing: mit scientific evaluation will not be (1) Within 30 days after publication of considered. the notice of opportunity for hearing, the applicant must submit to the Divi- [63 FR 10770, Mar. 5, 1998] sion of Dockets Management written objections and a request for a hearing in accordance with §§ 12.20 and 12.22.

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This request for a hearing must include of withdrawal of approval, the hearing each specific objection to the proposal will occur as soon as practicable. on which a hearing is requested, to- (d) The hearing will be open to the gether with a detailed description and public; however, if the Commissioner analysis of the factual information (in- finds that portions of the application cluding all relevant clinical and other which serve as a basis for the hearing investigational data) the applicant will contain information concerning a present in support of that objection. A method or process entitled to protec- request for a hearing may not rest tion as a trade secret, the part of the upon mere allegations or denials or hearing involving such portions will general descriptions of positions or not be public, unless the respondent so contentions, but must set forth specific specifies in the request for a hearing. reliable evidence showing there is a genuine and substantial issue of fact [81 FR 52997, Aug. 11, 2016] that requires a hearing. § 514.201 Procedures for hearings. (2) If the Commissioner determines upon review of the data and informa- Hearings relating to new animal tion submitted in the objections and drugs under section 512(d) and (e) of the request for a hearing that a hearing is act shall be governed by part 12 of this not justified because no genuine and chapter. substantial issue of fact precludes the [64 FR 63204, Nov. 19, 1999] refusal to approve the application or the withdrawal of approval of the ap- Subparts D–E [Reserved] plication (for example, the applicant has not identified any adequate and well-controlled clinical investigations Subpart F—Judicial Review to support the claims of effectiveness), the Commissioner will enter an order § 514.235 Judicial review. denying the hearing and stating the (a) The transcript and record shall be final findings and conclusions. certified by the Commissioner. In any (3) If the Commissioner determines case in which the Commissioner enters upon review of the data and informa- an order without a hearing pursuant to tion submitted in the objections and § 314.200(g) of this chapter, the re- request for a hearing that a hearing is quest(s) for hearing together with the justified, the Commissioner will pub- data and information submitted and lish a notice setting forth the fol- the Commissioner’s findings and con- lowing: clusions shall be included in the record (i) The regulation or order that is the certified by the Commissioner. subject of the hearing; (b) Judicial review of an order with- (ii) A statement specifying any part drawing approval of a new drug appli- of the regulation or order that has been cation, whether or not a hearing has stayed by operation of law or in the been held, may be sought by a manu- Commissioner’s discretion; facturer or distributor of an identical, (iii) The parties to the hearing; related, or similar drug product, as de- (iv) The specific issues of fact for res- fined in § 310.6 of this chapter, in a olution at the hearing; United States court of appeals pursu- (v) The presiding officer, or a state- ant to section 505(h) of the act. ment that the presiding officer will be [42 FR 4717, Jan. 25, 1977] designated in a later notice; and (vi) The date, time, and place of the prehearing conference, or a statement PART 515—MEDICATED FEED MILL that the date, time, and place will be LICENSE announced in a later notice. However, in the case of a denial of approval, the Subpart A—Applications hearing must not occur more than 90 Sec. days after expiration of the 30-day time 515.10 Medicated feed mill license applica- period in which to request a hearing, tions. unless the presiding officer and the ap- 515.11 Supplemental medicated feed mill li- plicant otherwise agree; and in the case cense applications.

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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 li- of the act. cense applications. 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 515.23 Voluntary revocation of medicated feeds conform to current good manu- feed mill license. facturing practice as described in sec- 515.24 Notice of revocation of a medicated tion 501(a)(2)(B) of the act and in part feed mill license. 515.25 Revocation of order refusing to ap- 225 of this chapter. prove a medicated feed mill license appli- (6) A certification that the facility cation or suspending or revoking a li- will establish and maintain all records cense. required by regulation or order issued 515.26 Services of notices and orders. under sections 512(m)(5)(A) or 504(a)(3)(A) of the act, and will permit Subpart C—Hearing Procedures access to, or copying or verification of 515.30 Contents of notice of opportunity for such records. a hearing. (7) A commitment that current ap- 515.31 Procedures for hearings. proved or index listed Type B and/or Type C medicated feed labeling for Subpart D—Judicial Review each Type B and/or Type C medicated 515.40 Judicial review. feed to be manufactured will be in the possession of the feed manufacturing AUTHORITY: 21 U.S.C. 360b, 371. facility prior to receiving the Type A SOURCE: 64 FR 63204, Nov. 19, 1999, unless medicated article containing such otherwise noted. drug. (8) A commitment to renew registra- Subpart A—Applications tion every year with FDA as required in part 207 of this chapter. § 515.10 Medicated feed mill license applications. (c) Applications must be completed, signed, and submitted to the Division (a) Medicated feed mill license appli- of Animal Feeds (HFV–220), Center for cations (Forms FDA 3448) may be ob- Veterinary Medicine, Food and Drug tained from the Public Health Service, Administration, 7500 Standish Pl., Consolidated Forms and Publications Rockville, MD 20855. Distribution Center, Washington Com- (d) Applications that are facially de- merce Center, 3222 Hubbard Rd., Land- ficient will be returned to the appli- over, MD 20785, or electronically from cant. All reasons for the return of the the Center for Veterinary Medicine application will be made known to the home page at http://www.fda.gov/cvm. applicant. (b) A completed medicated feed mill (e) Upon approval, the original copy license must contain the following in- of the application will be signed by an formation: authorized employee of FDA des- (1) The full business name and ad- ignated by the Commissioner of Food dress of the facility at which the manu- and Drugs, and a copy will be returned facturing is to take place. to the applicant. (2) The facility’s FDA registration number as required by section 510 of [64 FR 63204, Nov. 19, 1999, as amended at 72 the Federal Food, Drug, and Cosmetic FR 69121, Dec. 6, 2007; 81 FR 60221, Aug. 31, Act (the act). 2016] (3) The name, title, and signature of the responsible individual or individ- § 515.11 Supplemental medicated feed uals for that facility. mill license applications. (4) A certification that the animal (a) After approval of a medicated feed feeds bearing or containing new animal mill license application to manufac- drugs are manufactured and labeled in ture animal feed, a supplemental appli- accordance with the applicable regula- cation shall be submitted for a change

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in ownership and/or a change in mail- basis of any other information before ing address of the facility site. him that: (b) Each supplemental application (1) The application is incomplete, should be accompanied by a fully com- false, or misleading in any particular; pleted Form FDA 3448 and include an or explanation of the change. (2) The methods used in and the fa- (c) Within 30 working days after a cilities and controls used for the manu- supplemental application has been facturing, processing, and packaging of filed, if the Commissioner of Food and such animal feed are not adequate to Drugs determines that the application preserve the identity, strength, qual- provides adequate information respect- ity, and purity of the new animal drug ing the change in ownership and/or therein; or postal address of the facility site, then (3) The facility manufactures animal an authorized employee of the Food feeds bearing or containing new animal and Drug Administration designated by drugs in a manner that does not accord the Commissioner shall notify the ap- with the specifications for manufac- plicant that it is approved by signing ture or labels animal feeds bearing or and mailing to the applicant a copy of containing new animal drugs in a man- the Form FDA 3448. Supplemental ap- ner that does not accord with the con- plications that do not provide adequate ditions or indications of use that are information shall be returned to the published under section 512(i) or applicant and all reasons for the return 572(e)(2) of the act. of the application shall be made known (b) The Commissioner, as provided in to the applicant. § 515.30, shall expeditiously notify the applicant of an opportunity for a hear- Subpart B—Administrative Actions ing on the question of whether such ap- on Licenses plication is approvable, unless by the 30th day following the date of issuance § 515.20 Approval of medicated feed of the letter informing the applicant of mill license applications. the intention to issue a notice of op- Within 90 days after an application portunity for a hearing the applicant: has been filed under § 515.10, if the Com- (1) Withdraws the application; or missioner of Food and Drugs (the Com- (2) Waives the opportunity for a hear- missioner) determines that none of the ing; or grounds for denying approval specified (3) Agrees with the Commissioner on in section 512(m)(3) of the Federal an additional period to precede Food, Drug, and Cosmetic Act (the act) issuance of such notice of hearing. applies, an authorized employee of the Food and Drug Administration des- [64 FR 63204, Nov. 19, 1999, as amended at 72 ignated by the Commissioner shall no- FR 69121, Dec. 6, 2007] tify the applicant that it is approved by signing and mailing to the applicant § 515.22 Suspension and/or revocation a copy of the Form FDA 3448. of approval of a medicated feed mill license. § 515.21 Refusal to approve a medi- (a) The Secretary of Health and cated feed mill license application. Human Services may suspend a medi- (a) The Commissioner of Food and cated feed mill license approved under Drugs (the Commissioner) shall within section 512(m)(2) of the Federal Food, 90 days, or such additional period as Drug, and Cosmetic Act (the act) and may be agreed upon by the Commis- give the person holding the medicated sioner and the applicant, after the fil- feed mill license application prompt ing of an application under § 515.10, in- notice of this action and afford the ap- form the applicant in writing of his/her plicant the opportunity for an expe- intention to issue a notice of oppor- dited hearing on a finding that there is tunity for a hearing on a proposal to an imminent hazard to the health of refuse to approve the application, if the man or of the animals for which such Commissioner determines upon the animal feed is intended. basis of the application, on the basis of (b) The Commissioner of Food and a preapproval inspection, or upon the Drugs (the Commissioner) shall notify

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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 tion to contain any untrue statements section 501(a)(6) of the act, and the fa- of material fact or that would affect cility did not discontinue the manufac- the safety or effectiveness of the ani- ture, processing, packing, or holding of mal feeds manufactured at the facility such animal feed within a reasonable unless the applicant has supplemented time after receipt of written notice the application by filing a supple- from the Commissioner specifying the mental application under § 515.11. matter complained of. (c) The Commissioner may notify in writing the person holding an applica- § 515.23 Voluntary revocation of medi- tion approved under section 512(m)(2) of cated feed mill license. the act and afford an opportunity for a A license issued under section hearing on a proposal to revoke ap- 512(m)(2) of the Federal Food, Drug, proval of such application if the Com- and Cosmetic Act (the act) will be re- missioner finds: voked on the basis of a request for its (1) That the applicant has failed to revocation submitted in writing by a establish a system for maintaining re- responsible individual holding such li- quired records, or has repeatedly or de- cense on the grounds that the facility liberately failed to maintain such no longer manufactures any animal records or to make required reports in feed covered under § 558.4(b) of this accordance with a regulation or order chapter. A written request for such under sections 512(m)(5)(A) or revocation shall be construed as a 504(a)(3)(A) of the act, or the applicant waiver of the opportunity for a hearing has refused to permit access to, or as otherwise provided for in this sec- copying, or verification of, such tion. Revocation of approval of a medi- records as required by sections cated feed mill license under the provi- 512(m)(5)(B) or 504(a)(3)(B) of the act; or sions of this paragraph shall be with- (2) That on the basis of new informa- out prejudice. tion before him, evaluated together with the evidence before him when § 515.24 Notice of revocation of a medi- such license was issued, the methods cated feed mill license. used in, or the facilities and controls When a license approved under sec- used for, the manufacture, processing, tion 512 of the Federal Food, Drug, and packing, and holding of such animal Cosmetic Act (the act) is revoked by feed are inadequate to assure and pre- the Commissioner of Food and Drugs serve the identity, strength, quality, (the Commissioner), the Commissioner and purity of the new animal drug will give appropriate public notice of therein, and were not made adequate such action by publication in the FED- within a reasonable time after receipt ERAL REGISTER. of written notice from the Commis- sioner specifying the matter com- § 515.25 Revocation of order refusing plained of; or to approve a medicated feed mill li- (3) That on the basis of new informa- cense application or suspending or tion before him, evaluated together revoking a license. with the evidence before him when The Commissioner of Food and Drugs such license was issued, the labeling of (the Commissioner), upon his/her own any animal feeds, based on a fair eval- initiative or upon request of an appli- uation of all material facts, is false or cant stating reasonable grounds there- misleading in any particular and was for and if the Commissioner finds that not corrected within a reasonable time the facts so require, may issue an order

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approving a medicated feed mill license written appearance requesting the application that previously has had its hearing within 30 days after the publi- approval refused, suspended, or re- cation of the notice, giving the reason voked. why the application should not be refused or the medicated feed mill license § 515.26 Services of notices and orders. should not be revoked, together with a All notices and orders under this part well-organized and full-factual analysis 515 and section 512 of the Federal Food, of the information the applicant is pre- Drug, and Cosmetic Act (the act) per- pared to prove in support of his opposi- taining to medicated feed mill licenses tion to the Commissioner’s proposal. A shall be served: request for a hearing may not rest (a) In person by any officer or em- upon mere allegations or denials, but ployee of the Department of Health and must set forth specific facts showing Human Services designated by the there is a genuine and substantial issue Commissioner of Food and Drugs; or of fact that requires a hearing. When it (b) By mailing the order by certified mail addressed to the applicant or re- clearly appears from the information spondent at the applicant or respond- in the application and from the reasons ent’s last known address in the records and factual analysis in the request for of the Food and Drug Administration. the hearing that no genuine and substantial issue of fact precludes the re- Subpart C—Hearing Procedures fusal to approve the application or the revocation of approval of the applica- § 515.30 Contents of notice of oppor- tion, the Commissioner will enter an tunity for a hearing. order on this information, stating his/ (a) The notice to the applicant of op- her findings and conclusions. If a hear- portunity for a hearing on a proposal ing is requested and is justified by the by the Commissioner of Food and applicant’s response to the notice of Drugs (the Commissioner) to refuse to opportunity for a hearing, the issues approve a medicated feed mill license will be defined, an Administrative Law application or to revoke the approval Judge will be named, and the Judge of a medicated feed mill license will shall issue a written notice of the time specify the grounds upon which the and place at which the hearing will Commissioner proposes to issue this commence. In the case of denial of ap- order. On request of the applicant, the proval, such time shall be not more Commissioner will explain the reasons than 90 days after the expiration of for the action. The notice of oppor- such 30 days unless the Administrative tunity for a hearing will be published Law Judge and the applicant otherwise in the FEDERAL REGISTER and will agree; and, in the case of withdrawal of specify that the applicant has 30 days approval, such time shall be as soon as after issuance of the notice within practicable. which the Commissioner is required to (d) The hearing will be open to the file a written appearance electing public; however, if the Commissioner whether: finds that portions of the application (1) To avail himself of the oppor- which serve as a basis for the hearing tunity for a hearing; or contain information concerning a (2) Not to avail himself of the oppor- method or process entitled to protec- tunity for a hearing. tion as a trade secret, the part of the (b) If the applicant fails to file a written appearance in answer to the hearing involving such portions will notice of opportunity for hearing, this not be public, unless the respondent so failure will be construed as an election specifies in the appearance. not to avail himself of the opportunity § 515.31 Procedures for hearings. for the hearing, and the Commissioner without further notice may enter a Hearings relating to new animal final order. drugs under section 512(m)(3) and (m)(4) (c) If the applicant elects to avail of the Federal Food, Drug, and Cos- himself of the opportunity for a hear- metic Act (the act) shall be governed ing, the applicant is required to file a by part 12 of this chapter.

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Subpart D—Judicial Review 516.52 Availability for public disclosure of data and information in requests. § 515.40 Judicial review. Subpart C—Index of Legally Marketed Un- The transcript and record shall be approved New Animal Drugs for Minor certified by the Commissioner of Food Species and Drugs (the Commissioner). In any case in which the Commissioner enters 516.111 Scope of this subpart. an order without a hearing under 516.115 Definitions. § 314.200(g) of this chapter, the re- 516.117 Submission of correspondence under quest(s) for hearing together with the this subpart. data and information submitted and 516.119 Permanent-resident U.S. agent for foreign requestors and holders. the Commissioner’s findings and con- 516.121 Meetings. clusions shall be included in the record 516.123 Informal conferences regarding certified by the Commissioner. agency administrative actions. 516.125 Investigational use of minor species PART 516—NEW ANIMAL DRUGS new animal drugs to support indexing. FOR MINOR USE AND MINOR 516.129 Content and format of a request for SPECIES determination of eligibility for indexing. 516.131 Refuse to file a request for determination of eligibility for indexing. Subpart A—General Provisions 516.133 Denying a request for determination Sec. of eligibility for indexing. 516.1 Scope. 516.135 Granting a request for determination of eligibility for indexing. 516.2 Purpose. 516.137 Notification of decision regarding 516.3 Definitions. eligibility for indexing. Subpart B—Designation of a Minor Use or 516.141 Qualified expert panels. Minor Species New Animal Drug 516.143 Written report. 516.145 Content and format of a request for 516.11 Scope of this subpart. addition to the index. 516.12 Purpose. 516.147 Refuse to file a request for addition 516.13 Definitions. to the index. 516.14 Submission of requests for designa- 516.149 Denying a request for addition to the tion. index. 516.16 Eligibility to request designation. 516.151 Granting a request for addition to 516.20 Content and format of a request for the index. MUMS-drug designation. 516.153 Notification of decision regarding 516.21 Documentation of minor use status. index listing. 516.22 Permanent-resident U.S. agent for 516.155 Labeling of indexed drugs. foreign sponsor. 516.157 Publication of the index and content 516.23 Timing of requests for MUMS-drug of an index listing. designation. 516.161 Modifications to indexed drugs. 516.24 Granting MUMS-drug designation. 516.163 Change in ownership of an index file. 516.25 Refusal to grant MUMS-drug designa- 516.165 Records and reports. tion. 516.167 Removal from the index. 516.26 Amendment to MUMS-drug designa- 516.171 Confidentiality of data and information. tion in an index file. 516.27 Change in sponsorship. 516.28 Publication of MUMS-drug designa- Subpart D [Reserved] tions. 516.29 Termination of MUMS-drug designa- Subpart E—Conditionally Approved New tion. Animal Drugs For Minor Use and Minor 516.30 Annual reports for a MUMS-des- Species ignated drug. 516.31 Scope of MUMS-drug exclusive mar- 516.1684 Paclitaxel. keting rights. 516.2065 Rabacfosadine. 516.34 FDA recognition of exclusive mar- AUTHORITY: 21 U.S.C. 360ccc–1, 360ccc–2, 371. keting rights. 516.36 Insufficient quantities of MUMS-des- SOURCE: 72 FR 41017, July 26, 2007, unless ignated drugs. otherwise noted.

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Subpart A—General Provisions effectiveness claim for two different drugs; in most cases, direct compara- § 516.1 Scope. tive clinical trials will be necessary; or (a) This part implements section 573 (ii) The drug has been shown to be of the Federal Food, Drug, and Cos- safer than a conditionally-approved or metic Act (the act) (21 U.S.C. 360ccc–2) approved MUMS drug, that is other- and contains the following subparts: wise the same drug, in a substantial (1) Subpart A—General Provisions. portion of the target population, for (2) Subpart B—Designation of a example, by the elimination of an in- Minor Use or Minor Species New Ani- gredient or contaminant that is associ- mal Drug. ated with relatively frequent adverse (3) Subpart C [Reserved] effects. In some cases, direct compara- (4) Subpart D [Reserved] tive clinical trials will be necessary. (b) References in this part to regu- Infrequently, as used in the minor use latory sections of the Code of Federal definition, means a disease or condi- Regulations are to Chapter I of Title tion that is uncommon or that occurs 21, unless otherwise noted. only sporadically on an annualized basis. § 516.2 Purpose. Limited geographical areas, as used in This part establishes standards and the minor use definition, means re- procedures for implementing section gions of the United States distin- 573 of the act, including designation of guished by physical, chemical, or bio- minor use or minor species new animal logical factors that limit the distribu- drugs and associated exclusive mar- tion of a disease or condition. keting rights. Major species means cattle, horses, swine, chickens, turkeys, dogs, and § 516.3 Definitions. cats. (a) The definitions and interpreta- Minor species means animals, other tions contained in section 201 of the than humans, that are not major spe- Federal Food, Drug, and Cosmetic Act cies. (the act) (21 U.S.C. 321) apply to those Minor use means the intended use of terms when used in this part. a drug in a major species for an indica- (b) The following definitions of terms tion that occurs infrequently and in apply to all subparts of part 516: only a small number of animals or in Active moiety means the molecule or limited geographical areas and in only ion, excluding those appended portions a small number of animals annually. of the molecule that cause the drug to MUMS drug means a new animal be an ester, salt (including a salt with drug, as defined in section 201 of the hydrogen or coordination bonds), or act, intended for a minor use or for use other noncovalent derivative (such as a in a minor species. complex, chelate, or clathrate) of the Same dosage form means the same as molecule, responsible for the pharma- one of the dosage form categories spec- cological action of the drug substance. ified in the following parts of this Functionally superior means that a chapter: drug has been shown to provide a sig- (i) Part 520: Oral dosage form new nificant therapeutic or physiologic ad- animal drugs (excluding use in animal vantage over that provided by a condi- feeds as specified in part 558 of this tionally-approved or approved MUMS chapter). drug, that is otherwise the same drug, (ii) Part 522: Implantation or in one or more of the following ways: injectable dosage form new animal (i) The drug has been shown to be drugs. more effective, as assessed by effect on (iii) Part 524: Ophthalmic and topical a clinically meaningful endpoint in dosage form new animal drugs. adequate and well-controlled clinical (iv) Part 526: Intramammary dosage trials, than a conditionally approved or forms. approved MUMS drug, that is other- (v) Part 529: Certain other dosage wise the same drug. Generally, this form new animal drugs. would represent the same kind of evi- (vi) Part 558: New animal drugs for dence needed to support a comparative use in animal feeds.

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Same drug means a MUMS drug for (C) Two polynucleotide drugs con- which designation, indexing, or condi- sisting of two or more distinct nucleo- tional approval is sought that meets tides would be considered the same if the following criteria: they had an identical sequence of pu- (i) If it is a MUMS drug composed of rine and pyrimidine bases (or their de- small molecules and contains the same rivatives) bound to an identical sugar active moiety as a prior designated, backbone (ribose, deoxyribose, or modi- conditionally-approved, or approved fications of these sugars), unless the MUMS drug, even if the particular subsequent drug is shown to be func- ester or salt (including a salt with hy- tionally superior. drogen or coordination bonds) or other (D) Closely related, complex partly noncovalent derivative such as a com- definable drugs with similar pharmaco- plex, chelate or clathrate is not the logic intent would be considered the same, it is considered the same drug; same unless the subsequent drug is except that, if the prior MUMS drug is shown to be functionally superior. conditionally approved or approved and Same intended use means an intended the second MUMS drug is shown to be use of a MUMS drug, for which designa- functionally superior to the condition, indexing, or conditional approval tionally approved or approved MUMS is sought, that is determined to be the drug for the same intended use, it is same as (or not different from) a pre- not considered the same drug. viously designated, conditionally ap- (ii) If it is a MUMS drug composed of proved, or approved intended use of a large molecules (macromolecules) and MUMS drug. Same intended use is es- contains the same principal molecular tablished by comparing two intended structural features (but not necessarily uses and not by simply comparing the all of the same structural features) as specific language by means of which a prior designated, conditionally ap- the intent is established in labeling in proved, or approved MUMS drug, it is accordance with the following criteria: considered the same drug; except that, (i) Two intended uses are considered if the prior MUMS drug is condi- the same if one of the intended uses tionally approved or approved and the falls completely within the scope of the second MUMS drug is shown to be func- other. tionally superior to the conditionally (ii) For intended uses associated with approved or approved MUMS drug for diseases or conditions with multiple the same intended use, it is not consid- causative organisms, two intended uses ered the same drug. This criterion will are not considered the same when they be applied as follows to different kinds involve different causative organisms of macromolecules: or different subsets of causative orga- (A) Two protein drugs would be con- nisms of that disease or condition when sidered the same if the only differences the causative organisms involved can in structure between them were due to reliably be shown to be clinically sig- post-translational events or infidelity nificant causes of the disease or condi- of translation or transcription or were tion. minor differences in amino acid se- (iii) Two intended uses of a drug are quence; other potentially important not considered the same if they involve differences, such as different glycosyl- different intended species or different ation patterns or different tertiary definable subpopulations (including structures, would not cause the drugs ‘‘production classes’’) of a species. to be considered different unless the Small number of animals means equal subsequent drug is shown to be func- to or less than 50,000 horses; 70,000 dogs; tionally superior. 120,000 cats; 310,000 cattle; 1,450,000 pigs; (B) Two polysaccharide drugs would 14,000,000 turkeys; and 72,000,000 chick- be considered the same if they had ens. identical saccharide repeating units, Sponsor means the person requesting even if the number of units were to designation for a MUMS drug who vary and even if there were postpolym- must be the real party in interest of erization modifications, unless the sub- the development and the intended or sequent drug is shown to be function- actual production and sales of such ally superior. drug (in this context, the sponsor may

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be an individual, partnership, organiza- fied species, subpopulation of a species, tion, or association). Sponsor also or collection of species. means the person responsible for an in- MUMS-designated drug means a new vestigation of a new animal drug (in animal drug, as defined in section 201 this context, the sponsor may be an in- of the act, intended for a minor use or dividual, partnership, corporation, or for use in a minor species that has been Government agency or may be a manu- designated under section 573 of the act. facturer, scientific institution, or an MUMS-drug exclusive marketing rights investigator regularly and lawfully en- or exclusive marketing rights means that, gaged in the investigation of new ani- effective on the date of FDA condi- mal drugs). Sponsor also means the tional approval or approval as stated in person submitting or receiving ap- the approval letter of an application proval for a new animal drug applica- for a MUMS-designated drug, no condition (in this context, the sponsor may tional approval or approval will be be an individual, partnership, organiza- given to a subsequent application for tion, or association). In all contexts, the same drug, in the same dosage the sponsor is responsible for compli- form, for the same intended use for 7 ance with applicable provisions of the years, except as otherwise provided by act and regulations. law or in this subpart. [72 FR 41017, July 26, 2007, as amended at 74 FR 43050, Aug. 25, 2009; 75 FR 69588, Nov. 15, § 516.14 Submission of requests for 2010] designation. All correspondence relating to a re- Subpart B—Designation of a Minor quest for designation of a MUMS drug Use or Minor Species New must be addressed to the Director of Animal Drug the Office of Minor Use and Minor Spe- cies Animal Drug Development. Sub- § 516.11 Scope of this subpart. missions not including all elements This subpart implements section 573 specified in § 516.20 will be returned to of the act. Specifically, this subpart the sponsor without review. sets forth the procedures and requirements for submissions to FDA of re- § 516.16 Eligibility to request designa- quests for designation of a new animal tion. drug for a minor use or a minor spe- The person requesting designation cies. must be the sponsor and the real party in interest of the development and the § 516.12 Purpose. intended or actual production and sales This subpart establishes standards of the drug or the permanent-resident and procedures for determining eligi- U.S. agent for such a sponsor. bility for designation and the associated incentives and benefits described § 516.20 Content and format of a rein section 573 of the act, including a 7- quest for MUMS-drug designation. year period of exclusive marketing (a) A sponsor that submits a request rights. for designation of a new animal drug intended for a minor use or minor spe- § 516.13 Definitions. cies must submit each request in the The following definitions of terms form and containing the information apply only in the context of subpart B required in paragraph (b) of this sec- of this part: tion. While a request for designation Director means the Director of the Of- may involve multiple intended uses, fice of Minor Use and Minor Species each request for designation must con- Animal Drug Development of the FDA stitute a separate submission. A spon- Center for Veterinary Medicine. sor may request MUMS-drug designa- Intended use means the intended tion of a previously unapproved drug, treatment, control or prevention of a or a new intended use or dosage form disease or condition, or the intention for an already conditionally approved to affect the structure or function of or approved drug. Only one sponsor the body of animals within an identi- may receive MUMS-drug designation of

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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: dent U.S. agent including title, ad- (a) The estimated total number of dress, and telephone number; the estab- animals to which the drug could poten- lished name (and proprietary name, if tially be administered on an annual any) of the active pharmaceutical in- basis for the treatment, control, or pre- gredient of the drug; and the name and vention of the disease or condition for address of the source of the active which the drug is being developed, in- pharmaceutical ingredient of the drug. cluding animals administered the drug (3) A description of the proposed in- as part of herd or flock treatment, to- tended use for which the drug is being gether with a list of the sources (in- or will be investigated. cluding dates of information provided (4) A description of the drug and dos- and literature citations) for the esti- age form. mate. (5) A discussion of the scientific ra- (b) The estimated total number of tionale for the intended use of the animals referred to in paragraph (a) of this section may be further reduced to drug; specific reference, including only a subset of the estimated total date(s) of submission, to all data from number of animals if administration of nonclinical laboratory studies, clinical the drug is only medically justified for investigations, copies of pertinent un- this subset. To establish this, reques- published and published papers, and tors must demonstrate that adminis- other relevant data that are available tration of the drug to animals subject to the sponsor, whether positive, nega- to the disease or condition for which tive, or inconclusive. the drug is being developed other than (6) A specific description of the prod- the subset is not medically justified. uct development plan for the drug, its The sponsor must also include a list of dosage form, and its intended use. the sources (including dates of infor- (7) If the drug is intended for a minor mation provided and literature cita- use in a major species, documentation tions) for the justification that admin- in accordance with § 516.21, with ap- istration of the drug to animals other pended authoritative references, to than the targeted subset is medically demonstrate that such use is a minor inappropriate. use. (8) A statement that the sponsor sub- [72 FR 41017, July 26, 2007, as amended at 74 FR 43050, Aug. 25, 2009] mitting the request is the real party in interest of the development and the in- § 516.22 Permanent-resident U.S. agent tended or actual production and sales for foreign sponsor. of the product. Every foreign sponsor that seeks (9) A statement that the sponsor ac- MUMS-drug designation shall name a knowledges that, upon granting a re- permanent resident of the United quest for MUMS designation, FDA will States as the sponsor’s agent upon make information regarding the des- whom service of all processes, notices, ignation publicly available as specified orders, decisions, requirements, and in § 516.28. other communications may be made on [72 FR 41017, July 26, 2007, as amended at 75 behalf of the sponsor. Notifications of FR 69588, Nov. 15, 2010; 77 FR 18685, Mar. 28, changes in such agents or changes of 2012] address of agents should preferably be

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provided in advance, but not later than otherwise the same drug in the same 60 days after the effective date of such dosage form for the same intended use. changes. The permanent-resident U.S. (4) The sponsor has failed to provide: agent may be an individual, firm, or (i) A credible scientific rationale in domestic corporation and may rep- support of the intended use, resent any number of sponsors. The (ii) Sufficient information about the name and address of the permanent- product development plan for the drug, resident U.S. agent shall be provided to its dosage form, and its intended use to the Director of the Office of Minor Use establish that adherence to the plan and Minor Species Animal Drug Devel- can lead to successful drug develop- opment. ment in a timely manner, and (iii) Any other information required § 516.23 Timing of requests for MUMS- under § 516.20. drug designation. (b) FDA may refuse to grant a re- A sponsor may request MUMS-drug quest for MUMS-drug designation if designation at any time in the drug de- the request for designation contains an velopment process prior to the submis- untrue statement of material fact or sion of an application for either condi- omits material information. tional approval or approval of the § 516.26 Amendment to MUMS-drug MUMS drug for which designation is designation. being requested. (a) At any time prior to conditional § 516.24 Granting MUMS-drug designa- approval or approval of an application tion. for a MUMS-designated drug, the sponsor may apply for an amendment to the (a) FDA may grant the request for designated intended use if the proposed MUMS-drug designation if none of the change is due to new and unexpected reasons described in § 516.25 for refusal findings in research on the drug, infor- to grant such a request apply. mation arising from FDA recommenda- (b) When a request for MUMS-drug tions, or other unforeseen develop- designation is granted, FDA will notify ments. the sponsor in writing and will give (b) FDA will grant the amendment if public notice of the MUMS-drug des- it finds: ignation in accordance with § 516.28. (1) That the initial designation request was made in good faith; § 516.25 Refusal to grant MUMS-drug (2) That the amendment is intended designation. to make the MUMS-drug designated in- (a) FDA will refuse to grant a request tended use conform to the results of for MUMS-drug designation if any of new and unexpected findings in re- the following reasons apply: search on the drug, information arising (1) The drug is not intended for use in from FDA recommendations, or other a minor species or FDA determines unforeseen developments; and that there is insufficient evidence to (3) In the case of a minor use, that as demonstrate that the drug is intended of the date of the submission of the for a minor use in a major species. amendment request, the amendment (2) The drug is the same drug in the would not result in the intended use of same dosage form for the same in- the drug no longer being considered a tended use as one that already has a minor use. MUMS-drug designation but has not yet been conditionally approved or ap- § 516.27 Change in sponsorship. proved. (a) A sponsor may transfer sponsor- (3) The drug is the same drug in the ship of a MUMS-designated drug to an- same dosage form for the same in- other person. A change of sponsorship tended use as one that is already condi- will also transfer the designation sta- tionally approved or approved. A drug tus of the drug which will remain in ef- that FDA has found to be functionally fect for the new sponsor subject to the superior is not considered the same same conditions applicable to the drug as an already conditionally ap- former sponsor provided that at the proved or approved drug even if it is time of a potential transfer, the new

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and former sponsors submit the fol- (a) The name and address of the spon- lowing information in writing and ob- sor; tain permission from FDA: (b) The established name and trade (1) The former sponsor shall submit a name, if any, of the drug; letter to FDA that documents the (c) The dosage form of the drug; transfer of sponsorship of the MUMS- (d) The species and the proposed in- designated drug. This letter shall speci- tended use for which MUMS-drug des- fy the date of the transfer. The former ignation was granted; and sponsor shall also certify in writing to (e) The date designation was granted. FDA that a complete copy of the request for MUMS-drug designation, in- § 516.29 Termination of MUMS-drug cluding any amendments to the re- designation. quest, and correspondence relevant to (a) The sponsor of a MUMS-des- the MUMS-drug designation, has been ignated drug must notify FDA of any provided to the new sponsor. decision to discontinue active pursuit (2) The new sponsor shall submit a of conditional approval or approval of letter or other document containing such MUMS drug. FDA must terminate the following information: the designation upon such notification. (i) A statement accepting the MUMS- (b) A conditionally-approved or ap- drug designated file or application; proved MUMS-designated drug sponsor (ii) The date that the change in spon- must notify FDA at least 1 year before sorship is intended to be effective; it intends to discontinue the manufac- (iii) A statement that the new spon- ture of such MUMS drug. FDA must sor has a complete copy of the request terminate designation upon such noti- for MUMS-drug designation, including fication. any amendments to the request and (c) MUMS designation shall termi- any correspondence relevant to the nate upon the expiration of any appli- MUMS-drug designation; cable period of exclusive marketing rights under this subpart. (iv) A statement that the new spon- (d) FDA may terminate designation sor understands and accepts the re- if it independently determines that the sponsibilities of a sponsor of a MUMS- sponsor is not actively pursuing condi- designated drug established elsewhere tional approval or approval with due in this subpart; diligence. At a minimum, due diligence (v) The name and address of a new must be demonstrated by: primary contact person or permanent (1) Submission of annual progress re- resident U.S. agent; and ports in a timely manner in accordance (vi) Evidence that the new sponsor is with § 516.30 that demonstrate that the capable of actively pursuing approval sponsor is progressing in accordance with due diligence. with the drug development plan sub- (b) No sponsor may relieve itself of mitted to the agency under § 516.20 and responsibilities under the act or under (2) Compliance with all applicable re- this subpart by assigning rights to an- quirements of part 511 of this chapter. other person without: (e) Designation of a conditionally ap- (1) Assuring that the new sponsor proved or approved MUMS-designated will carry out such responsibilities; drug and the associated exclusive mar- and keting rights may be terminated if the (2) Obtaining prior permission from sponsor is unable to provide sufficient FDA. quantities of the drug to meet the needs for which it is designated. § 516.28 Publication of MUMS-drug (f) FDA may also terminate MUMS- designations. drug designation for any drug if the FDA will periodically update a pub- agency finds that: licly available list of MUMS-designated (1) The request for designation con- drugs. This list will be placed on file at tained an untrue statement of material the FDA Division of Dockets Manage- fact; or ment, and will contain the following (2) The request for designation omit- information for each MUMS-designated ted material information required by drug: this subpart; or

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(3) FDA subsequently finds that the (c) A brief discussion of any changes drug in fact had not been eligible for that may affect the MUMS-designated MUMS-drug designation at the time of drug status of the product. For exam- submission of the request; ple, situations in which testing data (4) The same drug, in the same dos- demonstrate that the proposed in- age form, for the same intended use be- tended use is inappropriate due to un- comes conditionally approved or ap- expected issues of safety or effective- proved for another sponsor; or ness. (5) FDA withdraws the conditional approval or approval of the application § 516.31 Scope of MUMS-drug exclusive for the new animal drug. marketing rights. (g) For a conditionally approved or (a) After conditional approval or ap- approved drug, termination of MUMS- proval of an application for a MUMS- drug designation also terminates the designated drug in the dosage form and sponsor’s exclusive marketing rights for the intended use for which MUMS- for the drug but does not withdraw the drug designation has been granted, conditional approval or approval of the FDA will not conditionally approve or drug’s application. approve another application or abbre- (h) Where a drug has been MUMS-des- viated application for the same drug in ignated for a minor use in a major spe- the same dosage form for the same in- cies, its designation will not be termi- tended use before the expiration of 7 nated on the grounds that the number years after the date of conditional ap- of animals to which the drug could po- proval or approval as stated in the ap- tentially be administered on an annual proval letter from FDA, except that basis for the treatment, control, or pre- such an application can be condi- vention of the disease or condition for tionally approved or approved sooner which the drug is being developed, in- if, and at such time as, any of the fol- cluding animals administered the drug lowing occurs: as part of herd or flock treatment, sub- (1) FDA terminates the MUMS-drug sequently increases. designation and associated exclusive (i) When a MUMS-drug designation is marketing rights under § 516.29; or terminated, FDA will notify the spon- (2) FDA withdraws the conditional sor in writing and will give public no- approval or approval of the application tice of the termination of the MUMS- for the drug for any reason; or drug designation. (3) The sponsor with exclusive marketing rights provides written consent § 516.30 Annual reports for a MUMS- to FDA to conditionally approve or ap- designated drug. prove another application before the Within 14 months after the date on expiration of 7 years; or which a MUMS drug is granted des- (4) The sponsor fails to assure a suffi- ignation and annually thereafter until cient quantity of the drug in accord- approval, the sponsor of a MUMS-des- ance with section 573 of the act and ignated drug shall submit a brief § 516.36. progress report on the drug to the in- (b) If an application for a MUMS drug vestigational new animal drug file ad- cannot be approved until the expira- dressed to the Director of the Office of tion of the period of exclusive mar- Minor Use and Minor Species Animal keting of a MUMS-designated drug, Drug Development that includes the FDA will so notify the sponsor in writ- following information: ing. (a) A short account of the progress of drug development including a descrip- § 516.34 FDA recognition of exclusive tion of studies initiated, ongoing, and marketing rights. completed, and a short summary of the (a) FDA will send the sponsor (or the status or results of such studies; permanent-resident U.S. agent, if ap- (b) A description of the investiga- plicable) timely written notice recog- tional plan for the coming year, as well nizing exclusive marketing rights when as any anticipated difficulties in devel- an application for a MUMS-designated opment, testing, and marketing; and drug has been conditionally approved

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or approved. The written notice will in- sions and will constitute final agency form the sponsor of the requirements action. An order terminating designa- for maintaining MUMS-designated tion and associated exclusive mar- drug exclusive marketing rights for the keting rights may issue whether or not full 7-year term. This notice will gen- there are other sponsors that can as- erally be contained in the letter condi- sure the availability of alternative tionally approving or approving the ap- sources of supply. Such an order will plication. not withdraw the conditional approval (b) When an application is condi- or approval of an application. Once ter- tionally approved or approved for a minated under this section, neither MUMS-designated drug that qualifies designation, nor exclusive marketing for exclusive marketing rights, FDA rights may be reinstated. will publish this information in the FEDERAL REGISTER at the time of the § 516.52 Availability for public disclosure of data and information in re- conditional approval or approval. This quests. notice will generally be contained in the notice of conditional approval or (a) FDA will not publicly disclose the approval of the application. existence of a request for MUMS-drug designation under section 573 of the act § 516.36 Insufficient quantities of prior to final FDA action on the re- MUMS-designated drugs. quest unless the existence of the re- (a) Under section 573 of the act, quest has been previously publicly dis- whenever FDA has reason to believe closed or acknowledged. that sufficient quantities of a condi- (b) Whether or not the existence of a tionally-approved or approved, MUMS- pending request for designation has designated drug to meet the needs for been publicly disclosed or acknowl- which the drug was designated cannot edged, no data or information in the re- be assured by the sponsor, FDA will so quest are available for public disclosure prior to final FDA action on the notify the sponsor of this possible in- request. sufficiency and will offer the sponsor (c) Except as provided in paragraph the following options, one of which (d) of this section, upon final FDA ac- must be exercised by a time that FDA tion on a request for designation, the specifies: public availability of data and informa- (1) Provide FDA information and tion in the request will be determined data regarding how the sponsor can as- in accordance with part 20 of this chap- sure the availability of sufficient quan- ter and other applicable statutes and tities of the MUMS-designated drug regulations. within a reasonable time to meet the (d) In accordance with § 516.28, FDA needs for which the drug was des- will make a cumulative list of all ignated; or MUMS-drug designations available to (2) Provide FDA in writing the spon- the public and update such list periodi- sor’s consent for the conditional ap- cally. In accordance with § 516.29, FDA proval or approval of other applica- will give public notice of the termi- tions for the same drug before the expi- nation of all MUMS-drug designations. ration of the 7-year period of exclusive marketing rights. (b) If, within the time that FDA Subpart C—Index of Legally Mar- specifies, the sponsor fails to consent keted Unapproved New Ani- to the conditional approval or approval mal Drugs for Minor Species of other applications and if FDA finds that the sponsor has not shown that it SOURCE: 72 FR 69121, Dec. 6, 2007, unless can assure the availability of sufficient otherwise noted. quantities of the MUMS-designated drug to meet the needs for which the § 516.111 Scope of this subpart. drug was designated, FDA will issue a This subpart implements section 572 written order terminating designation of the act and provides standards and of the MUMS drug and the associated procedures to establish an index of le- exclusive marketing rights. This order gally marketed unapproved new animal will state FDA’s findings and conclu- drugs. This subpart applies only to

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minor species and not to minor use in effectiveness of a new animal drug major species. This index is only avail- under consideration for indexing. able for new animal drugs intended for Requestor means the person making a use in a minor species for which there request for determination of eligibility is a reasonable certainty that the ani- for indexing or a request for addition mal or edible products from the animal to the index. will not be consumed by humans or Transgenic animal means an animal food-producing animals and for new whose genome contains a nucleotide se- animal drugs intended for use only in a quence that has been intentionally hatchery, tank, pond, or other similar modified in vitro, and the progeny of contained man-made structure in an such an animal, provided that the term early, nonfood life stage of a food-pro- ‘transgenic animal’ does not include an ducing minor species, where safety for animal of which the nucleotide se- humans is demonstrated in accordance quence of the genome has been modi- with the standard of section 512(d) of fied solely by selective breeding. the act (including, for an antimicrobial (b) The definitions of the following new animal drug, with respect to anti- terms are given in § 514.3 of this chap- microbial resistance). The index shall not include a new animal drug that is ter: contained in, or a product of, a Adverse drug experience. transgenic animal. Among its topics, Product defect/manufacturing defect. this subpart sets forth the standards Serious adverse drug experience. and procedures for: Unexpected adverse drug experience. (a) Investigational exemptions for in- (c) The definitions of the following dexing purposes; terms are given in § 516.3 of this chap- (b) Submissions to FDA of requests ter: for determination of eligibility of a Same dosage form. new animal drug for indexing; Same drug. (c) Establishment and operation of Same intended use. expert panels; (d) Submissions to FDA of requests § 516.117 Submission of correspond- for addition of a new animal drug to ence under this subpart. the index; (e) Modifications to index listings; Unless directed otherwise by FDA, (f) Publication of the index; and all correspondence relating to any as- (g) Records and reports. pect of the new animal drug indexing process described in this subpart must § 516.115 Definitions. be addressed to the Director, OMUMS. (a) The following definitions of terms The initial correspondence for a par- apply only in the context of subpart C ticular index listing should include the of this part: name and address of the authorized Director OMUMS means the Director contact person. Notifications of of the Office of Minor Use and Minor changes in such person or changes of Species Animal Drug Development of address of such person should be pro- the FDA Center for Veterinary Medi- vided in a timely manner. cine. Holder means the requestor of an § 516.119 Permanent-resident U.S. index listing after the request is grant- agent for foreign requestors and holders. ed and the new animal drug is added to the index. Every foreign requestor and holder Index means FDA’s list of legally shall name a permanent resident of the marketed unapproved new animal United States as their agent upon drugs for minor species. whom service of all processes, notices, Intended use has the same meaning as orders, decisions, requirements, and that given in § 516.13 of this chapter. other communications may be made on Qualified expert panel means a panel behalf of the requestor or holder. Noti- that is composed of experts qualified fications of changes in such agents or by scientific training and experience to changes of address of agents should evaluate the target animal safety and preferably be provided in advance, but

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not later than 60 days after the effec- will be the Director of the Center for tive date of such changes. The perma- Veterinary Medicine or his or her des- nent resident U.S. agent may be an in- ignee, excluding the Director of the Of- dividual, firm, or domestic corporation fice of Minor Use and Minor Species and may represent any number of re- Animal Drug Development and other questors or holders. The name and ad- persons significantly involved in the dress of the permanent-resident U.S. initial decision. agent shall be submitted to the Direc- (e) The person requesting an informal tor, OMUMS, and included in the index conference must provide a written re- file. sponse to FDA’s initial decision at least 2 weeks prior to the date of the § 516.121 Meetings. scheduled meeting. Generally, this (a) A requestor or potential requestor written response would be attached to is entitled to one or more meetings to the request for an informal conference. discuss the requirements for indexing a At the option of the person requesting new animal drug. an informal conference, such written (b) Requests for such meetings should response to FDA’s initial decision may be in writing, be addressed to the Di- act in lieu of a face-to-face meeting. In rector, OMUMS, specify the partici- this case, the informal conference will pants attending on behalf of the re- consist of a review by the presiding of- questor or potential requestor, and ficer of the submitted written response. contain a proposed agenda for the (f) The purpose of an informal con- meeting. ference is to discuss scientific and fac- (c) Within 30 days of receiving a re- tual issues. It will involve a discussion quest for a meeting, FDA will attempt of FDA’s initial decision and any writ- to schedule the meeting at a time ten response to that decision. agreeable to both FDA and the person (g) Internal agency review of a deci- making the request. sion must be based on the information § 516.123 Informal conferences regard- in the administrative file. If the person ing agency administrative actions. requesting an informal conference presents new information not in the file, (a) Should FDA make an initial deci- the matter will be returned to the ap- sion denying a request for determina- propriate lower level in the agency for tion of eligibility for indexing, termi- reevaluation based on the new informa- nating an investigational exemption, tion. determining that a qualified expert panel does not meet the selection cri- (h) Informal conferences under this teria, denying a request for addition to part are not subject to the separation the index, or removing a new animal of functions rules in § 10.55 of this chap- drug from the index, FDA will give ter. written notice that specifies the (i) The rules of evidence do not apply grounds for the initial decision and to informal conferences. No motions or provides an opportunity for an infor- objections relating to the admissibility mal conference for review of the deci- of information and views will be made sion. or considered, but any party to the (b) The written notice will include in- conference may comment upon or formation for scheduling the informal rebut all such data, information and conference and state that a written reviews. quest for a conference must be made (j) [Reserved] within 60 days of the date FDA sends (k) The presiding officer will prepare its notice. a written report regarding the subject (c) Within 45 days of receiving a re- of the informal conference that states quest for an informal conference, FDA and describes the basis for his or her will schedule and hold the informal findings. Whenever time permits, the conference at a time agreeable to both parties to the informal conference will FDA and the person making the re- have 30 days to review and comment on quest. the report. (d) Such an informal conference will (l) The administrative record of the be conducted by a presiding officer who informal conference will consist of:

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(1) The notice providing an oppor- species, other than for an investiga- tunity for an informal conference and tional use described in paragraph (a) of the written response to the notice. this section, shall meet the require- (2) All written information and views ments of this section. For such inves- submitted to the presiding officer at tigations, all provisions of part 511 of the conference or, at the discretion of this chapter apply with the following the presiding officer, thereafter. modifications: (3) The presiding officer’s written re- (1) Under § 511.1(a)(1) of this chapter, port. the label statement is as follows: (4) All correspondence and memo- ‘‘Caution. Contains a new animal randa of any and all meetings between drug for investigational use only in the participants and the presiding offi- laboratory animals or for tests in vitro cer. in support of index listing. Not for use (m) The administrative record of the in humans.’’ informal conference is closed to the (2) Under § 511.1(b)(1) of this chapter, submission of information at the close the label statement is as follows: of the conference, unless the presiding ‘‘Caution. Contains a new animal officer specifically permits additional drug for use only in investigational time for further submission. animals in clinical trials in support of (n) The administrative record of the index listing. Not for use in humans. informal conference specified herein Edible products of investigational ani- constitutes the exclusive record for de- mals are not to be used for food for hu- cision. mans or other animals unless author- § 516.125 Investigational use of minor ization has been granted by the U.S. species new animal drugs to sup- Food and Drug Administration or by port indexing. the U.S. Department of Agriculture.’’ (a) The investigational use of a new (3) Under § 511.1(b)(4) of this chapter, animal drug or animal feed bearing or the notice is titled ‘‘Notice of Claimed containing a new animal drug intended Investigational Exemption for a New solely for investigational use in minor Animal Drug for Index Listing’’ and is species shall meet the requirements of submitted in duplicate to the Director, part 511 of this chapter if the investiga- OMUMS. tional use is for the purpose of: (4) Under § 511.1(c)(3) of this chapter, (1) Demonstrating human food safety if an investigator is determined to be under section 572(a)(1)(B) of the act; ineligible to receive new animal drugs, (2) Demonstrating safety with re- each ‘‘Notice of Claimed Investiga- spect to individuals exposed to the new tional Exemption for a New Animal animal drug through its manufacture Drug for Index Listing’’ and each re- and use under section 572(c)(1)(F) of the quest for indexing shall be examined act; with respect to the reliability of infor- (3) Conducting an environmental as- mation submitted by the investigator. sessment under section 572(c)(1)(E) of (5) Under § 511.1(c)(4) and (d)(2) of this the act; or chapter, with respect to termination of (4) Obtaining approval of a new ani- exemptions, the sponsor of an inves- mal drug application or abbreviated tigation shall not be granted an oppor- new animal drug application under sec- tunity for a regulatory hearing before tion 512(b) of the act. FDA pursuant to part 16 of this chap- (b) Correspondence and information ter. Instead, the sponsor shall have an associated with investigations de- opportunity for an informal conference scribed in paragraph (a) of this section as described in § 516.123. shall not be sent to the Director, (6) Under § 511.1(c)(5) of this chapter, OMUMS, but shall be submitted to if the Commissioner of Food and Drugs FDA in accordance with the provisions determines, after the unreliable data of part 511 of this chapter. submitted by the investigator are (c) The investigational use of a new eliminated from consideration, that animal drug or animal feed bearing or the data remaining are such that a re- containing a new animal drug intended quest for addition to the index would solely for investigational use in minor have been denied, FDA will remove the

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new animal drug from the index in ac- route of administration, contraindica- cordance with § 516.167. tions, warnings, and any other signifi- (d) The investigational use of a new cant limitations associated with the animal drug or animal feed bearing or intended use(s) of the new animal drug; containing a new animal drug subject (5) A brief discussion of the need for to paragraph (c) of this section shall the new animal drug for the intended not be subject to the good laboratory use(s); practice requirements in part 58 of this (6) An estimate of the anticipated an- chapter. nual distribution of the new animal (e) Correspondence and information drug, in terms of the total quantity of associated with investigations de- active ingredient, after indexing; scribed in paragraph (c) of this section (7) Information to establish that the shall be sent to the Director, OMUMS, new animal drug is intended for use: in accordance with the provisions of (i) In a minor species for which there this section. is a reasonable certainty that the animal or edible products from the animal § 516.129 Content and format of a re- will not be consumed by humans or quest for determination of eligi- food-producing animals; or bility for indexing. (ii) In a hatchery, tank, pond, or (a) Each request for determination of other similar contained man-made eligibility: structure in (which includes on) an (1) May involve only one drug (or one early, non-food life stage of a food-pro- combination of drugs) in one dosage ducing minor species, and information form; to demonstrate food safety in accord- (2) May not involve a new animal ance with the standards of section drug that is contained in or a product 512(d) of the act and § 514.111 of this of a transgenic animal; chapter (including, for an anti- (3) May not involve the same drug in microbial new animal drug, with re- the same dosage form for the same inspect to antimicrobial resistance); tended use as a drug that is already ap- (8) A description of the methods used proved or conditionally approved; and in, and the facilities and controls used (4) Must be submitted separately. for, the manufacture, processing and (b) A request for determination of eli- packing of the new animal drug suffi- gibility for indexing may involve mul- cient to demonstrate that the re- tiple intended uses and/or multiple questor has established appropriate minor species. However, if a request for specifications for the manufacture and determination of eligibility for index- control of the new animal drug and ing that contains multiple intended that the requestor has an under- uses and/or multiple minor species can- standing of current good manufac- not be granted in any part, the entire turing practices; request will be denied. (9) Either a claim for categorical ex- (c) A requestor must submit two cop- clusion under § 25.30 or § 25.33 of this ies of a dated request signed by the au- chapter or an environmental assess- thorized contact person for determina- ment under § 25.40 of this chapter; tion of eligibility for indexing that (10) Information sufficient to support contains the following: the conclusion that the new animal (1) Identification of the minor species drug is safe under section 512(d) of the or groups of minor species for which act with respect to individuals exposed the new animal drug is intended; to the new animal drug through its (2) Information regarding drug com- manufacture and use; and ponents and composition; (11) The name and address of the con- (3) A statement of the intended use(s) tact person or permanent-resident U.S. of the new animal drug in the identi- agent. fied minor species or groups of minor species; § 516.131 Refuse to file a request for (4) A statement of the proposed con- determination of eligibility for in- ditions of use associated with the stat- dexing. ed intended use(s) of the new animal (a) If a request for determination of drug, including the proposed dosage, eligibility for indexing contains all of

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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. § 516.133 Denying a request for deter- (b) FDA may deny a request for de- mination of eligibility for indexing. termination 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. determines upon the basis of the request evaluated together with any (c) When a request for determination other information before it with re- of eligibility for indexing is denied, spect to the new animal drug that: FDA will notify the requestor in ac- (1) The same drug in the same dosage cordance with § 516.137. form for the same intended use is already approved or conditionally ap- § 516.135 Granting a request for determination of eligibility for indexing. proved; (2) There is insufficient information (a) FDA will grant the request for de- to demonstrate that the new animal termination of eligibility for indexing drug is intended for use: if none of the reasons described in (i) In a minor species for which there § 516.133 for denying such a request ap- is a reasonable certainty that the ani- plies. mal or edible products from the animal (b) When a request for determination will not be consumed by humans or of eligibility for indexing is granted, food-producing animals, or FDA will notify the requestor in ac- (ii) In a hatchery, tank, pond, or cordance with § 516.137. other similar contained man-made structure in (which includes on) an § 516.137 Notification of decision re- early, non-food life stage of a food-pro- garding eligibility for indexing. ducing minor species, and there is in- (a) Within 90 days after the filing of sufficient evidence to demonstrate a request for a determination of eligi- safety for humans in accordance with bility for indexing based on the standard of section 512(d) of the act § 516.129(c)(7)(i), or 180 days for a re- and § 514.111 of this chapter (including, quest based on § 516.129(c)(7)(ii), FDA for an antimicrobial new animal drug, shall grant or deny the request, and no- with respect to antimicrobial resist- tify the requestor of FDA’s decision in ance); writing. (3) The new animal drug is contained in or is a product of a transgenic ani- (b) If FDA denies the request, FDA mal; shall provide due notice and an oppor- (4) There is insufficient information tunity for an informal conference as to demonstrate that the requestor has described in § 516.123 regarding its deci- established appropriate specifications sion. A decision of FDA to deny a re- for the manufacture and control of the quest for determination of eligibility new animal drug and that the re- for indexing following an informal con- questor has an understanding of cur- ference shall constitute final agency rent good manufacturing practices; action subject to judicial review. (5) The requester fails to submit an adequate environmental assessment § 516.141 Qualified expert panels. under § 25.40 of this chapter or fails to (a) Establishment of a qualified expert provide sufficient information to estab- panel. Establishing a qualified expert lish that the requested action is sub- panel is the first step in the process of

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requesting the addition of a new ani- tion criteria listed in paragraph (b) of mal drug to the index. A qualified ex- this section. pert panel may not be established until (ii) Provide each potential expert FDA has determined that the new ani- panel member a copy of section 572 of mal drug is eligible for indexing. The the act (the indexing provisions of the requestor must choose members for the statute) and this subpart and obtain qualified expert panel in accordance certification that he or she has a work- with selection criteria listed in para- ing knowledge of the information. graph (b) of this section and submit in- (iii) Provide each potential expert formation about these proposed mem- panel member a written statement de- bers to FDA. FDA must determine scribing the purpose and scope of his or whether the proposed qualified expert her participation on the qualified ex- panel meets the selection criteria prior pert panel and obtain certification that to the panel beginning its work. Quali- he or she has read and understood the fied expert panels operate external to information. The written statement FDA and are not subject to the Federal should describe the duties and respon- Advisory Committee Act, as amended, sibilities of qualified expert panels and 5 U.S.C. App. their members established by para- (b) Criteria for the selection of a quali- graphs (e) and (f) of this section, in- fied expert panel. (1) A qualified expert cluding the need to prepare a written panel member must be an expert quali- report under § 516.143. fied by training and experience to (iv) Obtain information from each po- evaluate a significant aspect of target tential expert panel member dem- animal safety or effectiveness of the onstrating that he or she is qualified new animal drug under consideration. by training and experience to evaluate (2) A qualified expert panel member the target animal safety and effective- must certify that he or she has a work- ness of the new animal drug under con- ing knowledge of section 572 of the act sideration. This information can be ob- (the indexing provisions of the statute) tained from a comprehensive cur- and this subpart, and that he or she has riculum vitae or similar document. also read and understood a clear writ- (v) Notify each potential expert panel ten statement provided by the re- member that he or she must submit in- questor stating his or her duties and formation relating to potential conflict responsibilities with respect to review- of interest directly to FDA in a timely ing the new animal drug proposed for manner, as required in paragraph (e)(6) addition to the index. of this section. (3) A qualified expert panel member (2) The requestor must submit, in may not be an FDA employee. writing, the names and addresses of the (4) A qualified expert panel must proposed qualified expert panel mem- have at least three members. bers and sufficient information about (5) A qualified expert panel must each proposed member for FDA to de- have members with a range of expertise termine whether the panel meets the such that the panel, as a whole, is selection criteria listed in paragraphs qualified by training and experience to (b)(1) through (b)(5) of this section. evaluate the target animal safety and (3) After FDA has determined that effectiveness of the new animal drug the qualified expert panel meets the se- under consideration. lection criteria, the requestor must (6) Unless FDA makes a determina- provide to the panel all information tion to allow participation notwith- known by the requestor that is rel- standing an otherwise disqualifying fi- evant to a determination of the target nancial interest, a qualified expert animal safety and the effectiveness of panel member must not have a conflict the new animal drug at issue. In addi- of interest or the appearance of a con- tion, the requestor must notify FDA of flict of interest, as described in para- the name of the qualified expert panel graph (g) of this section. leader. (c) Requestor responsibilities. (1) The (4) The requestor must immediately requestor must: notify FDA if it believes a qualified ex- (i) Choose members for the qualified pert panel member no longer meets the expert panel in accordance with selec- selection criteria listed in paragraph

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(b) of this section or is otherwise not in ments of this section shall constitute compliance with the requirements of final agency action subject to judicial this section. review. (5) If a qualified expert panel member (e) Responsibilities of a qualified expert cannot complete the review for which panel member. A qualified expert panel he or she was selected, the requestor member must do the following: must either choose a replacement or (1) Continue to meet all selection cri- justify the continued work of the panel teria described in paragraph (b) of this in the absence of the lost panelist. In section. either case, the requestor must submit (2) Act in accordance with generally sufficient information for FDA to determine whether the proposed revised accepted professional and ethical busi- qualified expert panel meets the selec- ness practices. tion criteria listed in paragraphs (b)(1) (3) Review all information relevant through (b)(5) of this section. to a determination of the target ani- (6) The requestor must keep copies of mal safety and effectiveness of the new all information provided to, or received animal drug provided by the requestor. from, qualified expert panel members, The panel should also consider all rel- including the written report, for 2 evant information otherwise known by years after the completion of the re- the panel members, including anec- port, or the product is added to the dotal information. index, whichever occurs later, and (4) Participate in the preparation of make them available to a duly author- the written report of the findings of ized employee of the agency at all rea- the qualified expert panel, described in sonable times. § 516.143. (d) FDA responsibilities. (1) FDA will (5) Sign, or otherwise approve in determine whether the requestor’s pro- writing, the written report. Such sig- posed qualified expert panel meets the nature or other written approval will selection criteria listed in paragraph serve as certification that the written (b) of this section. FDA will expedi- report meets the requirements of the tiously inform the requestor, in writ- written report in § 516.143. ing, of its determination. If FDA determines that the qualified expert panel (6) Provide the information relating does not meet the selection criteria, to potential conflict of interest de- FDA will provide due notice and an op- scribed in paragraph (g) of this section portunity for an informal conference as to FDA for its consideration. Such in- described in § 516.123. A determination formation should be submitted directly by FDA that a proposed qualified ex- to the Director, OMUMS, when notified pert panel does not meet the selection by the requestor. criteria following an informal con- (7) Immediately notify the requestor ference shall constitute final agency and FDA of any change in conflict of action subject to judicial review. interest status. (2) If FDA determines that a qualified (8) Certify at the time of submission expert panel no longer meets the selec- of the written report that there has tion criteria listed in paragraph (b) of been no change in conflict of interest this section or that the panel or its status, or identify and document to members are not in compliance with FDA any such change. the requirements of this section, the (f) Additional responsibilities of a quali- agency will expeditiously inform the fied expert panel leader. (1) The qualified requestor, in writing, of this deter- expert panel leader must ensure that mination and provide due notice and an opportunity for an informal conference the activities of the panel are per- as described in § 516.123. A determina- formed efficiently and in accordance tion by FDA, following an informal with generally accepted professional conference, that a qualified expert and ethical business practices. panel no longer meets the selection cri- (2) The qualified expert panel leader teria listed in paragraph (b) of this sec- serves as the principal point of contact tion or that the panel or its members between representatives of the agency are not in compliance with the require- and the panel.

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(3) The qualified expert panel leader animal drug being reviewed by the is responsible for submitting the writ- qualified expert panel. ten report and all notes or minutes re- (vii) Has entered into an agreement lating to panel deliberations to the rein which fees charged or accepted are questor. contingent upon the panel member (4) The qualified expert panel leader making a favorable evaluation or opin- must maintain a copy of the written ion. report and all notes or minutes relat- (viii) Receives payment for services ing to panel deliberations that are sub- related to preparing information the mitted to the requestor for 2 years requestor presents to the qualified ex- after the report is submitted. Such pert panel, other than for services re- records must be made available to a lated to the written report described in duly authorized employee of the agen- § 516.143. cy for inspection at all reasonable (3) To permit FDA to make a decision times. regarding potential conflict of interest, (g) Prevention of conflicts of interest. a potential qualified expert panel mem- (1) For the purposes of this subpart, ber must submit to the Director, FDA will consider a conflict of interest OMUMS, the following information re- to be any financial or other interest that could impair a person’s objec- lating to themselves, their spouse, tivity in serving on the qualified expert their minor children, their general panel or could create an unfair com- partners, or any organizations in which petitive advantage for a person or orga- they serve as an officer, director, trust- nization. ee, general partner or employee, re- (2) Factors relevant to whether there garding the following issues to the ex- is a conflict of interest or the appear- tent that they are, in any way, rel- ance of a conflict of interest include evant to the subject of the review of whether the qualified expert panel the qualified expert panel: member, their spouse, their minor chil- (i) Investments (for example, stocks, dren, their general partners, or any or- bonds, retirement plans, trusts, part- ganizations in which they serve as an nerships, sector funds, etc.), including officer, director, trustee, general part- for each the following: Name of the ner or employee: firm, type of investment, owner (self, (i) Is currently receiving or seeking spouse, etc.), number of shares / cur- funding from the requestor through a rent value. contract or research grant (either di- (ii) Employment (full or part time, rectly or indirectly through another current or under negotiation), includ- entity, such as a university). ing for each the following: Name of the (ii) Has any employment, contrac- firm, relationship (self, spouse, etc.), tual, or other financial arrangement position in firm, date employment or with the requestor other than receiving negotiation began. a reasonable fee for serving as a mem- (iii) Consultant/advisor (current or ber of the qualified expert panel. under negotiation), including for each (iii) Has any ownership or financial the following: Name of the firm, topic/ interest in any drug, drug manufac- issue, amount received, date initiated. turer, or drug distributor which will (iv) Contracts, grants, Cooperation benefit from either a favorable or unfavorable evaluation or opinion. Research and Development Agreement (CRADAs) (current or under negotia- (iv) Has any ownership or financial interest in the new animal drug being tion), including for each the following: reviewed by the qualified expert panel. Type of agreement, product under (v) Has participated in the design, study and indications, amount of remu- manufacture, or distribution of any neration (institution/self), time period, drug that will benefit from either a fa- sponsor (government, firm, institution, vorable or unfavorable opinion of the individual), role of the person (site in- qualified expert panel. vestigator, principal investigator, co- (vi) Has provided within 1 year any investigator, partner, no involvement, consultative services regarding the new other), awardee.

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(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 (c) For all information considered, or under negotiation), including for including anecdotal information, in- each the following: Firm, topic/issue, clude either a citation to published lit- amount received (honorarium/travel), erature or a summary of the informa- date. tion; (viii) Whether the potential qualified (d) State the panel’s opinion regard- expert panel member, their spouse, ing whether the benefits of using the their minor children, their general new animal drug for the proposed use partners or any organizations in which in a minor species outweigh its risks to they serve as an officer, director, trust- the target animal, taking into account ee, general partner or employee, have the harm being caused by the absence had, at any time in the past, involve- of an approved or conditionally-ap- ment of the kind noted in paragraph proved new animal drug for the minor (g)(3)(i) through (g)(3)(vii) of this sec- species in question; tion with respect to the animal drug (e) Be signed, or otherwise approved that is the subject of the qualified ex- in writing, by all panel members, in ac- pert panel review. cordance with § 516.141; and (ix) Whether there are any other in- (f) If the panel unanimously con- volvements (other kinds of relation- cludes that the benefits of using the ships) that would give the appearance new animal drug for the proposed use of a conflict of interest which have not in a minor species outweigh its risks to been described in paragraph (g)(3)(i) the target animal, taking into account through (g)(3)(viii) of this section. the harm being caused by the absence of an approved or conditionally-ap- (x) In all cases, a response of ‘‘no,’’ proved new animal drug for the minor ‘‘none,’’ or ‘‘not applicable’’ is satisfac- species in question, the written report tory when there is no relevant informa- shall: tion to submit. (1) Provide draft labeling that in- (xi) A certification statement signed cludes all conditions of use and limita- by the potential qualified expert panel tions of use of the new animal drug member to the effect that all informa- deemed necessary by the panel to as- tion submitted is true and complete to sure that the benefits of use of the new the best of their knowledge, that they animal drug outweigh the risks, or pro- have read and understood their obliga- vide narrative information from which tions as an expert panel member, and such labeling can be written by the re- that they will notify FDA and the requestor; and questor of any change in their conflict (2) Include a recommendation regard- of interest status. ing whether the new animal drug (4) The fact that a qualified expert should be limited to use under the pro- panel member receives a reasonable fee fessional supervision of a licensed vet- for services as a member of the quali- erinarian. fied expert panel, provided that the fee is no more than commensurate with § 516.145 Content and format of a re- the value of the time that the member quest for addition to the index. devotes to the review process, does not (a) A requestor may request addition constitute a conflict of interest or the of a new animal drug to the index only appearance of a conflict of interest. after the new animal drug has been granted eligibility for indexing. § 516.143 Written report. (b) A requestor shall submit two cop- The written report required in ies of a dated request signed by the au- § 516.145(b)(3) shall: thorized contact for addition of a new

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

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drug for the minor species in question; (c) The labeling of an indexed drug or shall contain such other information as (7) The request contains any untrue may be prescribed in the index listing. statement of a material fact or omits material information. § 516.157 Publication of the index and (b) When a request for addition to the content of an index listing. index is denied, FDA will notify the re- (a) FDA will make the list of indexed questor in accordance with § 516.153. drugs available through the FDA Web site at http://www.fda.gov. A printed § 516.151 Granting a request for addi- copy can be obtained by writing to the tion to the index. Freedom of Information Staff or by vis- (a) FDA will grant the request for ad- iting FDA’s Freedom of Information dition of a new animal drug to the Staff’s Public Reading Room at the ad- index if none of the reasons described dress listed on the Agency’s Web site at in § 516.149 for denying such a request http://www.fda.gov. applies. (b) The list will contain the following (b) When a request for addition of a information for each indexed drug: new animal drug to the index is grant- (1) The name and address of the per- ed, FDA will notify the requestor in ac- son who holds the index listing; cordance with § 516.153. (2) The name of the drug and the in- § 516.153 Notification of decision re- tended use and conditions of use for garding index listing. which it is indexed; (a) Within 180 days after the filing of (3) Product labeling; and a request for addition of a new animal (4) Conditions and any limitations drug to the index, FDA shall grant or that FDA deems necessary regarding deny the request and notify the re- use of the drug. questor of FDA’s decision in writing. [72 FR 69121, Dec. 6, 2007; 76 FR 31470, June 1, (b) If FDA denies the request for ad- 2011, as amended at 79 FR 68115, Nov. 14, 2014] dition of a new animal drug to the index, FDA shall provide due notice § 516.161 Modifications to indexed and an opportunity for an informal drugs. conference as described in § 516.123. A (a) After a drug is listed in the index, decision of FDA to deny a request to certain modifications to the index list- index a new animal drug following an ing may be requested. Any modifica- informal conference shall constitute tion of an index listing may not cause final agency action subject to judicial review. an indexed drug to be a different drug (or different combination of drugs) or a § 516.155 Labeling of indexed drugs. different dosage form. If such modification is requested, FDA will notify the (a) The labeling of an indexed drug holder that a new index listing is re- that is found to be eligible for indexing quired for the new drug or dosage form. under § 516.129(c)(7)(i) shall state, prominently and conspicuously: ‘‘NOT (b) Modifications to the indexed drug APPROVED BY FDA.—Legally marketed will fall under one of three categories as an FDA indexed product. Extra-label and must be submitted as follows: use is prohibited.’’ ‘‘This product is not to (1) Urgent changes. (i) The following be used in animals intended for use as modifications to an indexed drug or its food for humans or other animals.’’ labeling should be made as soon as pos- (b) The labeling of an indexed drug sible, and a request to modify the in- that was found to be eligible for index- dexed drug should be concurrently sub- ing for use in an early, non-food life mitted: stage of a food-producing minor species (A) The addition to package labeling, animal, under § 516.129(c)(7)(ii), shall promotional labeling, or prescription state, prominently and conspicuously: drug advertising of additional warning, ‘‘NOT APPROVED BY FDA.—Legally contraindication, side effect, or cau- marketed as an FDA indexed product. tionary information. Extra-label use is prohibited.’’

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

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(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 annual report in accordance with (2) Fifteen-day indexed drug alert re- §§ 516.161 and 516.165. port. The holder must submit a report (b) Upon receiving the necessary in- on each serious, unexpected adverse formation to support a change of own- drug event, regardless of the source of ership of a drug’s index file, FDA will the information. The holder must sub- update its publicly-available listing in mit the report within 15 working days accordance with § 516.157. of first receiving the information. The mailing cover must be plainly marked § 516.165 Records and reports. ‘‘15–Day Indexed Drug Alert Report.’’ (a) Scope and purpose. (1) The record- (3) Annual indexed drug experience re- keeping and reporting requirements of port. The holder must submit this re- this section apply to all holders of in- port every year on the anniversary dexed drugs, including indexed drugs date of the letter granting the request intended for use in medicated feeds. for addition of the new animal drug to (2) A holder is not required to report the index, or within 60 days thereafter. information under this section if the The report must contain data and in- holder has reported the same informa- formation for the full reporting period. tion under § 514.80 of this chapter. Any previously submitted information (3) The records and reports referred contained in the report must be identi- to in this section are in addition to fied as such. The holder may ask FDA those required by the current good to change the date of submission and, manufacturing practice regulations in after approval of such request, file such parts 211, 225, and 226 of this chapter. reports by the new filing date. The re- (4) FDA will review the records and port must contain the following: reports required in this section to de- (i) The number of distributed units of termine, or facilitate a determination, each size, strength, or potency (e.g., whether there may be grounds for re- 100,000 bottles of 100 5-milligram tab- moving a drug from the index under lets; 50,000 10-milliliter vials of 5- per- section 572(f) of the act. cent solution) distributed during the (b) Recordkeeping requirements. (1) reporting period. This information Each holder of an indexed drug must must be presented in two categories: establish and maintain complete files Quantities distributed domestically containing full records of all informa- and quantities exported. This information pertinent to the safety or effec- tion must include any distributor-la- tiveness of the indexed drug. Such beled product.

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(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 (vi) Any other information pertinent index, the benefits of using the new to safety or effectiveness of the in- animal drug for the indexed use do not dexed drug not previously reported outweigh its risks to the target ani- under this section. mal, taking into account the harm (4) Distributor’s statement. At the time caused by the absence of an approved of initial distribution of an indexed or conditionally-approved new animal drug by a distributor, the holder must drug for the minor species in question; submit a report containing the fol- (4) Any of the conditions in lowing: § 516.133(a)(2), (5), or (6) are present; (i) The distributor’s current product (5) The manufacture of the new ani- labeling. This must be identical to that mal drug is not in accordance with cur- in the index listing except for a dif- rent good manufacturing practices; ferent and suitable proprietary name (6) The labeling, distribution, or pro- (if used) and the name and address of motion of the new animal drug is not the distributor. The name and address in accordance with the index listing; of the distributor must be preceded by (7) The conditions and limitations of an appropriate qualifying phrase such use associated with the index listing as ‘‘manufactured for’’ or ‘‘distributed have not been followed; or by.’’ (8) Any information used to support (ii) A signed statement by the dis- the request for addition to the index tributor stating: contains any untrue statement of ma- (A) The category of the distributor’s terial fact. operations (e.g., wholesale or retail); (b) The agency may partially remove (B) That the distributor will dis- an indexing listing if, in the opinion of tribute the drug only under the indexed the agency, such partial removal would drug labeling; satisfactorily resolve a safety or effec- (C) That the distributor will promote tiveness issue otherwise warranting re- the indexed drug only for use under the moval of the listing under section conditions stated in the index listing; 572(f)(1)(B) of the act. and (c) FDA may immediately suspend a (D) If the indexed drug is a prescrip- new animal drug from the index if FDA tion new animal drug, that the dis- determines that there is a reasonable tributor is regularly and lawfully en- probability that the use of the drug

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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 information in an index file. by reference in the index file. Such summaries do not constitute the full (a) For purposes of this section, the information described under section index file includes all data and infor- 572(c) and (d) of the act on which the mation submitted to or incorporated safety or effectiveness of the drug may by reference into the index file, such as be determined. Such summaries will be data and information related to inves- based on the draft Freedom of Informa- tigational use exemptions under tion summary submitted under § 516.125, requests for determination of § 516.145, which will be reviewed and, eligibility for indexing, requests for ad- where appropriate, revised by FDA. dition to the index, modifications to (3) A protocol for a test or study, un- indexed drugs, changes in ownership, less it is shown to fall within the ex- reports submitted under § 516.165, and emption established for trade secrets master files. The availability for public and confidential commercial informa- disclosure of any record in the index tion in § 20.61 of this chapter. file shall be handled in accordance with (4) Adverse reaction reports, product the provisions of this section. experience reports, consumer com- (b) The existence of an index file will plaints, and other similar data and in- not be disclosed by FDA before an formation, after deletion of the fol- index listing has been made public by lowing: FDA, unless it has previously been publicly disclosed or acknowledged by the (i) Names and any information that requestor. would identify the person using the (c) If the existence of an index file product. has not been publicly disclosed or ac- (ii) Names and any information that knowledged, no data or information in would identify any third party involved the index file are available for public with the report, such as a veterinarian. disclosure. (5) A list of all active ingredients and (d) If the existence of an index file any inactive ingredients previously has been publicly disclosed or acknowl- disclosed to the public as defined in edged before an index listing has been § 20.81 of this chapter. made public by FDA, no data or infor- (6) An assay method or other analyt- mation contained in the file will be ical method, unless it serves no regu- available for public disclosure before latory or compliance purpose and is such index listing is made public, but shown to fall within the exemption es- the agency may, at its discretion, dis- tablished in § 20.61 of this chapter. close a brief summary of such selected (7) All correspondence and written portions of the safety and effectiveness summaries of oral discussions relating data as are appropriate for public con- to the index file, in accordance with sideration of a specific pending issue, the provisions of part 20 of this chap- e.g., at an open session of a Food and ter. Drug Administration advisory com- (f) The following data and informa- mittee or pursuant to an exchange of tion in an index file are not available important regulatory information with for public disclosure unless they have a foreign government. been previously disclosed to the public (e) After FDA sends a written notice as defined in § 20.81 of this chapter, or to the requestor granting a request for they relate to a product or ingredient addition to the index, the following that has been abandoned and they no

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longer represent a trade secret or con- Subpart E—Conditionally Ap- fidential commercial or financial infor- proved New Animal Drugs For mation as defined in § 20.61 of this chap- Minor Use and Minor Species ter: (1) Manufacturing methods or proc- SOURCE: 72 FR 57200, Oct. 9, 2007, unless esses, including quality control proce- otherwise noted. dures. (2) Production, sales, distribution, § 516.1684 Paclitaxel. and similar data and information, ex- (a) Specifications. Each vial of powder cept that any compilation of such data contains 60 milligrams (mg) paclitaxel. and information aggregated and pre- Each milliliter of constituted solution pared in a way that does not reveal contains 1 mg paclitaxel. data or information which is not avail- (b) Sponsor. See No. 052818 in able for public disclosure under this 510.600(c) of this chapter. provision is available for public disclo- (c) Conditions of use in dogs—(1) sure. Amount. Administer 150 mg per square (3) Quantitative or semiquantitative meter of body surface area intra- formulas. venously over 15 to 30 minutes, once (g) Subject to the disclosure provi- every 3 weeks, for up to 4 doses. sions of this section, the agency shall (2) Indications for use. For the treat- regard the contents of an index file as ment of nonresectable stage III, IV, or confidential information unless specifi- V mammary carcinoma in dogs that cally notified in writing by the holder have not received previous chemo- of the right to disclose, to reference, or therapy or radiotherapy. For the treat- otherwise utilize such information on ment of resectable and nonresectable behalf of another named person. squamous cell carcinoma in dogs that (h) For purposes of this regulation, have not received previous chemo- safety and effectiveness data include therapy or radiotherapy. all studies and tests of an animal drug (3) Limitations. Federal law restricts on animals and all studies and tests on this drug to use by or on the order of a the animal drug for identity, stability, licensed veterinarian. It is a violation purity, potency, and bioavailability. of Federal law to use this product (i) Safety and effectiveness data and other than as directed in the labeling. information that have not been pre- [79 FR 18158, Apr. 1, 2014] viously disclosed to the public are available for public disclosure at the § 516.2065 Rabacfosadine. time any of the following events occurs (a) Specifications. Each vial of powder unless extraordinary circumstances are contains 16.4 milligrams (mg) shown: rabacfosadine. Each milliliter of con- (1) No work is being or will be under- stituted solution contains 8.2 mg taken to have the drug indexed in ac- rabacfosadine. cordance with the request. (b) Sponsor. See No. 086072 in (2) A final determination is made § 510.600(c) of this chapter. that the drug cannot be indexed and all (c) Conditions of use in dogs—(1) legal appeals have been exhausted. Amount. Administer rabacfosadine at 1 (3) The drug has been removed from mg/kilogram body weight as a 30- the index and all legal appeals have minute intravenous infusion, once been exhausted. every 3 weeks, for up to 5 doses. (4) A final determination has been (2) Indications for use. For the treat- made that the animal drug is not a new ment of lymphoma in dogs. animal drug. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation Subpart D [Reserved] of Federal law to use this product other than as directed in the labeling. [82 FR 12169, Mar. 1, 2017]

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PART 520—ORAL DOSAGE FORM 520.443 Chlortetracycline tablets and boluses. NEW ANIMAL DRUGS 520.445 Chlortetracycline and sulfamethazine powder. Sec. 520.446 Clindamycin capsules and tablets. 520.23 Acepromazine. 520.447 Clindamycin solution. 520.28 Acetazolamide. 520.452 Clenbuterol syrup. 520.38 Albendazole oral dosage forms. 520.455 Clomipramine tablets. 520.38a Albendazole suspension. 520.462 Clorsulon drench. 520.38b Albendazole paste. 520.522 Cyclosporine. 520.43 Afoxolaner. 520.530 Cythioate oral liquid. 520.48 Altrenogest. 520.531 Cythioate tablets. 520.62 Aminopentamide. 520.534 Decoquinate. 520.82 Aminopropazine oral dosage forms. 520.538 Deracoxib. 520.82a Aminopropazine. 520.540 Dexamethasone oral dosage forms. 520.82b Aminopropazine and neomycin. 520.540a Dexamethasone powder. 520.88 Amoxicillin oral dosage forms. 520.540b Dexamethasone tablets and 520.88a Amoxicillin trihydrate film-coated boluses. tablets. 520.540c Dexamethasone chewable tablets. 520.88b Amoxicillin trihydrate for oral sus- 520.563 Dexamethasone chewable tablets. pension. 520.580 Dichlorophene and toluene. 520.88c Amoxicillin trihydrate oral suspen- 520.581 Dichlorophene tablets. sion. 520.596 Dichlorvos powder. 520.88d Amoxicillin trihydrate soluble pow- 520.598 Dichlorvos tablets. der. 520.600 Dichlorvos capsules and pellets. 520.88e Amoxicillin trihydrate boluses. 520.602 Dichlorvos gel. 520.88f Amoxicillin trihydrate tablets. 520.606 Diclazuril. 520.88g Amoxicillin trihydrate and 520.608 Dicloxacillin. clavulanate potassium tablets. 520.620 Diethylcarbamazine oral dosage forms. 520.88h Amoxicillin trihydrate and 520.622 Diethylcarbamazine citrate oral dos- clavulanate potassium for oral suspen- age forms. sion. 520.622a Diethylcarbamazine citrate tablets. 520.90 Ampicillin oral dosage forms. 520.622b Diethylcarbamazine citrate syrup. 520.90a Ampicillin tablets. 520.622c Diethylcarbamazine citrate chew- 520.90b Ampicillin capsules. able tablets. 520.90c Ampicillin boluses. 520.623 Diethylcarbamazine and 520.100 Amprolium. oxibendazole chewable tablets. 520.110 Apramycin sulfate soluble powder. 520.645 Difloxacin. 520.154 Bacitracin oral dosage forms. 520.666 Dirlotapide. 520.154a Bacitracin methylenedisalicylate. 520.763 Dithiazanine oral dosage forms. 520.154b Bacitracin methylenedisalicylate 520.763a Dithiazanine tablets. and streptomycin sulfate powder. 520.763b Dithiazanine powder. 520.154c Bacitracin zinc soluble powder. 520.763c Dithiazanine iodide and piperazine 520.222 Bunamidine hydrochloride. citrate suspension. 520.246 Butorphanol tablets. 520.766 Domperidone. 520.260 n-Butyl chloride. 520.784 Doxylamine. 520.284 Cambendazole oral dosage forms. 520.804 Enalapril. 520.284a Cambendazole suspension. 520.812 Enrofloxacin. 520.284b Cambendazole pellets. 520.816 Epsiprantel. 520.284c Cambendazole paste. 520.823 Erythromycin. 520.292 Capromorelin. 520.852 Estriol. 520.301 Caramiphen ethanedisulfonate and 520.863 Ethylisobutrazine. ammonium chloride tablets. 520.870 Etodolac. 520.302 Carnidazole tablets. 520.903 Febantel oral dosage forms. 520.304 Carprofen. 520.903a Febantel paste. 520.314 Cefadroxil. 520.903b Febantel suspension. 520.370 Cefpodoxime tablets. 520.903c Febantel and praziquantel paste. 520.376 Cephalexin. 520.903d Febantel tablets. 520.390 Chloramphenicol oral dosage forms. 520.905 Fenbendazole oral dosage forms. 520.390a Chloramphenicol tablets. 520.905a Fenbendazole suspension. 520.390b Chloramphenicol capsules. 520.905b Fenbendazole granules. 520.390c Chloramphenicol palmitate oral 520.905c Fenbendazole paste. suspension. 520.905d Fenbendazole powder. 520.420 Chlorothiazide. 520.905e Fenbendazole blocks. 520.434 Chlorphenesin carbamate tablets. 520.928 Firocoxib tablets. 520.441 Chlortetracycline powder. 520.930 Firocoxib paste.

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520.955 Florfenicol. 520.1341 Megestrol. 520.960 Flumethasone. 520.1367 Meloxicam. 520.970 Flunixin. 520.1372 Methimazole. 520.980 Fluoxetine. 520.1380 Methocarbamol. 520.998 Fluralaner. 520.1408 Methylprednisolone. 520.1010 Furosemide. 520.1409 Methylprednisolone and aspirin. 520.1044 Gentamicin sulfate oral dosage 520.1422 Metoserpate hydrochloride. forms. 520.1430 Mibolerone. 520.1044a Gentamicin sulfate oral solution. 520.1441 Milbemycin. 520.1044b Gentamicin sulfate pig pump oral 520.1443 Milbemycin oxime and lufenuron. solution. 520.1445 Milbemycin oxime and 520.1044c Gentamicin sulfate powder. praziquantel. 520.1060 Glucose and glycine. 520.1447 Milbemycin oxime, lufenuron, and 520.1084 Grapiprant. praziquantel tablets. 520.1100 Griseofulvin. 520.1450 Morantel tartrate oral dosage 520.1120 Haloxon oral dosage forms. forms. 520.1120a Haloxon drench. 520.1450a Morantel tartrate bolus. 520.1120b Haloxon boluses. 520.1450b Morantel tartrate cartridge. 520.1130 Hetacillin. 520.1450c Morantel tartrate sustained-re- 520.1150 Imepitoin. lease trilaminate cylinder/sheet. 520.1156 Imidacloprid. 520.1451 Moxidectin tablets. 520.1157 Iodinated casein. 520.1452 Moxidectin gel. 520.1158 Iodochlorhydroxyquin. 520.1453 Moxidectin and praziquantel gel. 520.1189 Itraconazole. 520.1454 Moxidectin solution. 520.1192 Ivermectin paste. 520.1468 Naproxen. 520.1193 Ivermectin tablets and chewables. 520.1194 Ivermectin meal. 520.1484 Neomycin. 520.1195 Ivermectin liquid. 520.1510 Nitenpyram. 520.1196 Ivermectin and pyrantel tablets. 520.1604 Oclacitinib. 520.1197 Ivermectin sustained-release bolus. 520.1615 Omeprazole. 520.1198 Ivermectin and praziquantel paste. 520.1616 Orbifloxacin tablets.. 520.1199 Ivermectin, pyrantel, and 520.1618 Orbifloxacin suspension. praziquantel tablets. 520.1628 Oxfendazole powder and pellets. 520.1200 Ivermectin, fenbendazole, and 520.1629 Oxfendazole paste. praziquantel tablets. 520.1630 Oxfendazole suspension. 520.1204 Kanamycin, bismuth subcarbonate, 520.1631 Oxfendazole and trichlorfon paste. activated attapulgite. 520.1638 Oxibendazole. 520.1242 Levamisole. 520.1660 Oxytetracycline. 520.1242a Levamisole powder. 520.1660a Oxytetracycline and carbomycin. 520.1242b Levamisole boluses or oblets. 520.1660b Oxytetracycline hydrochloride 520.1242c Levamisole and piperazine. capsules. 520.1242d Levamisole resinate. 520.1660c Oxytetracycline hydrochloride 520.1242e Levamisole hydrochloride effer- tablets/boluses. vescent tablets. 520.1660d Oxytetracycline powder. 520.1242f Levamisole gel. 520.1696 Penicillin. 520.1242g Levamisole resinate and famphur 520.1696a Penicillin G powder. paste. 520.1696b Penicillin V powder. 520.1248 Levothyroxine. 520.1696c Penicillin V tablets. 520.1263 Lincomycin. 520.1705 Pergolide. 520.1263a Lincomycin tablets and syrup. 520.1720 Phenylbutazone oral dosage forms. 520.1263b Lincomycin powder. 520.1720a Phenylbutazone tablets and 520.1265 Lincomycin and spectinomycin boluses. powder. 520.1720b Phenylbutazone granules. 520.1284 Liothyronine. 520.1720c Phenylbutazone paste. 520.1286 Lotilaner. 520.1720d Phenylbutazone gel. 520.1288 Lufenuron tablets. 520.1720e Phenylbutazone powder. 520.1289 Lufenuron suspension. 520.1760 Phenylpropanolamine. 520.1310 Marbofloxacin. 520.1780 Pimobendan. 520.1315 Maropitant. 520.1802 Piperazine-carbon disulfide complex 520.1320 Mebendazole. oral dosage forms. 520.1326 Mebendazole and trichlorfon oral 520.1802a Piperazine-carbon disulfide com- dosage forms. plex suspension. 520.1326a Mebendazole and trichlorfon pow- 520.1802b Piperazine-carbon disulfide com- der. plex boluses. 520.1326b Mebendazole and trichlorfon paste. 520.1802c Piperazine-carbon disulfide com- 520.1330 Meclofenamic acid granules. plex with phenothiazine suspension. 520.1331 Meclofenamic acid tablets. 520.1803 Piperazine citrate capsules.

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520.1805 Piperazine phosphate with thenium 520.2261a Sulfamethazine solution. closylate tablets. 520.2261b Sulfamethazine powder. 520.1806 Piperazine suspension. 520.2280 Sulfamethizole and methenamine. 520.1840 Poloxalene. 520.2325 Sulfaquinoxaline oral dosage forms. 520.1846 Polyoxyethylene (23) lauryl ether 520.2325a Sulfaquinoxaline powder and solu- blocks. tion. 520.1855 Ponazuril. 520.2325b Sulfaquinoxaline drench. 520.1860 Pradofloxacin. 520.2330 Sulfisoxazole tablets. 520.1870 Praziquantel tablets. 520.2335 Telmisartan. 520.1871 Praziquantel and pyrantel. 520.2340 Tepoxalin. 520.1872 Praziquantel, pyrantel pamoate, 520.2345 Tetracycline. and febantel tablets. 520.2345a Tetracycline capsules. 520.1880 Prednisolone. 520.2345b Tetracycline tablets. 520.1900 Primidone. 520.2345c Tetracycline boluses. 520.1920 Prochlorperazine and isopropamide. 520.2345d Tetracycline powder. 520.1921 Prochlorperazine, isopropamide, 520.2345e Tetracycline solution. and neomycin. 520.2345f Tetracycline phosphate complex 520.1962 Promazine. and sodium novobiocin capsules. 520.2002 Propiopromazine. 520.2345g Tetracycline hydrochloride and so- 520.2041 Pyrantel pamoate chewable tablets. dium novobiocin tablets. 520.2042 Pyrantel pamoate tablets. 520.2345h Tetracycline hydrochloride, so- 520.2043 Pyrantel pamoate suspension. dium novobiocin, and prednisolone tab- 520.2044 Pyrantel pamoate paste. lets. 520.2045 Pyrantel tartrate powder. 520.2362 Thenium closylate. 520.2046 Pyrantel tartrate pellets. 520.2380 Thiabendazole oral dosage forms. 520.2075 Robenacoxib. 520.2380a Thiabendazole top dressing and 520.2086 Sarolaner. mineral protein block. 520.2098 Selegiline. 520.2380b Thiabendazole drench or paste. 520.2100 Selenium and vitamin E. 520.2380c Thiabendazole bolus. 520.2123 Spectinomycin oral dosage forms. 520.2380d Thiabendazole and piperazine cit- 520.2123a Spectinomycin tablets. rate. 520.2123b Spectinomycin powder. 520.2380e Thiabendazole and piperazine 520.2123c Spectinomycin solution. phosphate. 520.2130 Spinosad. 520.2380f Thiabendazole and trichlorfon. 520.2134 Spinosad and milbemycin. 520.2455 Tiamulin. 520.2150 Stanozolol. 520.2471 Tilmicosin. 520.2158 Streptomycin. 520.2473 Tioxidazole oral dosage forms. 520.2170 Sulfabromomethazine. 520.2473a Tioxidazole granules. 520.2184 Sulfachloropyrazine. 520.2473b Tioxidazole paste. 520.2200 Sulfachlorpyridazine. 520.2475 Toceranib. 520.2215 Sulfadiazine/pyrimethamine sus- 520.2481 Triamcinolone acetonide tablets. pension. 520.2482 Triamcinolone acetonide oral pow- 520.2218 Sulfamerazine, sulfamethazine, and der. sulfaquinoxaline powder. 520.2483 Triamcinolone. 520.2220 Sulfadimethoxine oral dosage 520.2520 Trichlorfon oral dosage forms. forms. 520.2520a Trichlorfon and atropine. 520.2220a Sulfadimethoxine oral solution 520.2520b Trichlorofon boluses. 520.2520c Trichlorofon granules. and soluble powder. 520.2520d Trichlorfon, phenothiazine, and pi- 520.2220b Sulfadimethoxine suspension. perazine. 520.2220c Sulfadimethoxine tablet. 520.2582 Triflupromazine. 520.2220d Sulfadimethoxine bolus. 520.2598 Trilostane. 520.2220e Sulfadimethoxine extended-release 520.2604 Trimeprazine and prednisolone tab- bolus. lets. 520.2220f Sulfadimethoxine and ormetoprim 520.2605 Trimeprazine and prednisolone cap- tablet. sules. 520.2240 Sulfaethoxypyridazine. 520.2610 Trimethoprim and sulfadiazine tab- 520.2240a Sulfaethoxypyridazine solution. lets. 520.2240b Sulfaethoxypyridazine tablets. 520.2611 Trimethoprim and sulfadiazine 520.2260 Sulfamethazine oral dosage forms. paste. 520.2260a Sulfamethazine oblet, tablet, and 520.2612 Trimethoprim and sulfadiazine sus- bolus. pension. 520.2260b Sulfamethazine sustained-release 520.2613 Trimethoprim and sulfadiazine boluses. powder. 520.2260c Sulfamethazine sustained-release 520.2640 Tylosin. tablets. 520.2645 Tylvalosin. 520.2261 Sulfamethazine sodium oral dosage forms. AUTHORITY: 21 U.S.C. 360b.

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

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worm (Oesophagostomum columbianum), 4th stage larvae of lungworms and large-mouth bowel worm (Chabertia (Dictyocaulus viviparus). ovina)); adult and larval stages of (3) Limitations. Administer as a single lungworms (Dictyocaulus filaria). oral dose. Do not slaughter within 27 (iii) Limitations. Do not slaughter days of last treatment. Do not use in within 7 days of last treatment. Do not female dairy cattle of breeding age. Do administer to ewes during first 30 days not administer to female cattle during of pregnancy or for 30 days after re- first 45 days of pregnancy or for 45 days moval of rams. after removal of bulls. Consult your (3) Goats. Administer 11.36 percent veterinarian for assistance in the diag- suspension: nosis, treatment, and control of para- (i) Amount. 4.54 mg/lb body weight (10 sitism. mg/kg) as a single oral dose using dos- [54 FR 51385, Dec. 15, 1989, as amended at 56 ing gun or dosing syringe. FR 50653, Oct. 8, 1991; 60 FR 55658, Nov. 2, (ii) Indications for use. For the treat- 1995. Redesignated at 78 FR 66264, Nov. 5, ment of adult liver flukes (Fasciola he- 2013, as amended at 79 FR 28816, May 20, 2014] patica) in nonlactating goats. § 520.43 Afoxolaner. (iii) Limitations. Do not slaughter within 7 days of last treatment. Do not (a) Specifications. Each chewable tab- administer to does during the first 30 let contains 11.3, 28.3, 68, or 136 milli- days of pregnancy or for 30 days after grams (mg) afoxolaner. removal of bucks. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. [73 FR 11027, Feb. 29, 2008. Redesignated at 78 (c) Conditions of use—(1) Amount. Ad- FR 66264, Nov. 5, 2013, as amended at 79 FR minister orally once a month at a min- 28816, May 20, 2014] imum dosage of 1.14 mg/pound (lb) (2.5 mg/kilogram (kg)). § 520.38b Albendazole paste. (2) Indications for use. Kills adult (a) Specifications. The product con- fleas; for the treatment and prevention tains 30 percent albendazole. of flea infestations (Ctenocephalides (b) Sponsor. See No. 054771 in felis); for the treatment and control of § 510.600(c) of this chapter. black-legged tick (Ixodes scapularis), (c) Related tolerances. See § 556.34 of American dog tick (Dermacentor this chapter. variabilis), lone star tick (Amblyomma (d) Conditions of use in cattle—(1) americanum), and brown dog tick Amount. Equivalent to 4.54 milligrams (Rhipicephalus sanguineus) infestations per 1 pound of body weight (10 milli- in dogs and puppies 8 weeks of age and grams per kilogram). older, weighing 4 pounds of body (2) Indications for use. For removal weight or greater, for 1 month; and for and control of the following internal the prevention of Borrelia burgdorferi parasites of cattle: adult liver flukes infections as a direct result of killing (Fasciola hepatica); heads and segments Ixodes scapularis vector ticks. of tapeworms (Moniezia benedeni, M. (3) Limitations. Federal law restricts expansa); adult and 4th stage larvae of this drug to use by or on the order of a stomach worms (brown stomach worms licensed veterinarian. including 4th stage inhibited larvae [78 FR 66264, Nov. 5, 2013, as amended at 79 (Ostertagia ostertagi); barberpole worm FR 37619, July 2, 2014; 84 FR 8972, Mar. 13, (Haemonchus contortus, H. placei); small 2019; 84 FR 39182, Aug. 9, 2019] stomach worm (Trichostrongylus axei)); adult and 4th stages larvae of intes- § 520.48 Altrenogest. tinal worms (thread-necked intestinal (a) Specifications. Each milliliter worm (Nematodirus spathiger, N. (mL) of solution contains 2.2 milli- helvetianus); small intestinal worm grams (mg) altrenogest. (Cooperia punctata and C. oncophora)); (b) Sponsors. See Nos. 000061, 051072, adult stages of intestinal worms and 061133 in § 510.600(c) of this chapter. (hookworm (Bunostomum phlebotmum); (c) Tolerances. See § 556.36 of this bankrupt worm (Trichostrongylus chapter. colubriformis), nodular worm (d) Conditions of use—(1) Horses—(i) (Oesophagostomum radiatum)); adult and Amount. 1.0 mL per 110 pounds body

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weight (0.044 mg/kg) daily for 15 con- (3) Limitations. Federal law restricts secutive days. this drug to use by or on the order of a (ii) Indications for use. For suppres- licensed veterinarian. sion of estrus in mares. [79 FR 28816, May 20, 2014] (iii) Limitations. Do not use in horses intended for human consumption. Fed- § 520.82 Aminopropazine oral dosage eral law restricts this drug to use by or forms. on the order of a licensed veterinarian. § 520.82a Aminopropazine. (2) Swine—(i) Amount. Administer 6.8 mL (15 mg altrenogest) per gilt once (a) Specifications. Each tablet con- daily for 14 consecutive days by top- tains aminopropazine fumarate equiva- dressing on a portion of each gilt’s lent to 25 percent aminopropazine base. daily feed. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (ii) Indications for use. For synchroni- (c) Conditions of use in dogs and cats— zation of estrus in sexually mature (1) Amount. Administer orally at a dos- gilts that have had at least one estrous age of 1 to 2 milligrams per pound of cycle. body weight, repeated every 12 hours as (iii) Limitations. Do not use in gilts indicated. having a previous or current history of (2) Indications for use. For reducing uterine inflammation (i.e., acute, excessive smooth muscle contractions, subacute or chronic endometritis). such as occur in urethral spasms asso- Gilts must not be slaughtered for ciated with urolithiasis. human consumption for 21 days after (3) Limitations. Federal law restricts the last treatment. this drug to use by or on the order of a licensed veterinarian. [66 FR 47960, Sept. 17, 2001, as amended at 68 FR 62006, Oct. 31, 2003; 72 FR 9455, Feb. 21, [79 FR 28816, May 20, 2014] 2008; 74 FR 61516, Nov. 25, 2009; 77 FR 32012, May 31, 2012; 80 FR 34278, June 16, 2015; 82 FR § 520.82b Aminopropazine and neomy- 21690, May 10, 2017; 83 FR 13635, Mar. 30, 2018; cin. 84 FR 8972, Mar. 13, 2019] (a) Specifications. Each tablet contains aminopropazine fumarate equiva- § 520.62 Aminopentamide. lent to 25 percent aminopropazine base (a) Specifications. Each tablet con- and neomycin sulfate equivalent to 50 tains 0.2 milligram (mg) milligrams (mg) of neomycin base. aminopentamide hydrogen sulphate. (b) Sponsor. See No. 000061 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—(1) (c) Conditions of use in dogs and cats— Amount. Administer orally at a dosage (1) Amount. Administer orally every 8 of 1 to 2 mg per pound of body weight, to 12 hours as follows: For animals repeated every 12 hours as indicated. weighing up to 10 pounds (lbs): 0.1 mg; (2) Indications for use. For control of for animals weighing 11 to 20 lbs: 0.2 bacterial diarrhea caused by organisms susceptible to neomycin and to reduce mg; for animals weighing 21 to 50 lbs: smooth muscle contractions. 0.3 mg; for animals weighing 51 to 100 (3) Limitations. Federal law restricts lbs: 0.4 mg; for animal weighing over this drug to use by or on the order of a 100 lbs: 0.5 mg. Dosage may be gradu- licensed veterinarian. ally increased up to a maximum of five times the suggested dosage. Oral ad- [79 FR 28816, May 20, 2014] ministration of tablets may be pre- § 520.88 Amoxicillin oral dosage forms. ceded by subcutaneous or intramuscular use of the injectable § 520.88a Amoxicillin trihydrate film- form of the drug. coated tablets. (2) Indications for use. For the treat- (a) Specifications. Each tablet con- ment of vomiting and/or diarrhea, nau- tains amoxicillin trihydrate equivalent sea, acute abdominal visceral spasm, to 50, 100, 150, 200, or 400 milligrams pylorospasm, or hypertrophic gastritis. (mg) amoxicillin.

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

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(2) [Reserved] after the latest treatment. Federal law restricts this drug to use by or on the [57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 60 FR 55658, Nov. 2, order of a licensed veterinarian 1995; 62 FR 13302, Mar. 20, 1997; 67 FR 67521, [57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. Nov. 6, 2002; 68 FR 54658, Sept. 18, 2003; 68 FR 15, 1992; 58 FR 18304, Apr. 8, 1993, as amended 55824, Sept. 29, 2003; 79 FR 28816, May 20, 2014; at 60 FR 55658, Nov. 2, 1995; 62 FR 5525, Feb. 81 FR 17607, Mar. 30, 2016] 6, 1997; 79 FR 28817, May 20, 2014]

§ 520.88c Amoxicillin trihydrate oral § 520.88e Amoxicillin trihydrate suspension. boluses. (a) Specifications. Each 0.8-milliliter (a) Specifications. Each bolus contains dose contains amoxicillin trihydrate amoxicillin trihydrate equivalent to equivalent to 40 milligrams (mg) 400 milligrams (mg) amoxicillin. amoxicillin. (b) Sponsor. See No. 054771 in (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Related tolerances. See § 556.38 of (c) Related tolerances. See § 556.38 of this chapter. this chapter. (d) Conditions of use in swine—(1) (d) Conditions of use in cattle—(1) Amount. Administer 40 mg orally twice Amount. Administer 400 mg per 100 a day using a dosing pump. Treat ani- pounds of body weight twice daily. mals for 48 hours after all symptoms Treatment should be continued for 48 have subsided but not beyond 5 days. hours after all symptoms have subsided (2) Indications for use. Treatment of but not to exceed 5 days. baby pigs under 10 pounds for porcine (2) Indications for use. Treatment of colibacillosis caused by Escherichia coli bacterial enteritis when due to suscep- susceptible to amoxicillin. tible Escherichia coli in preruminating (3) Limitations. Do not slaughter dur- calves including veal calves. ing treatment or for 15 days after lat- (3) Limitations. Do not slaughter ani- est treatment. Federal law restricts mals during treatment or for 20 days this drug to use by or on the order of a after the latest treatment. Federal law licensed veterinarian. restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37319, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995; 79 FR 28817, May 20, [57 FR 37320, Aug. 18, 1992, as amended at 60 2014; 85 FR 18118, Apr. 1, 2020] FR 55659, Nov. 2, 1995; 62 FR 5526, Feb. 6, 1997; 79 FR 28817, May 20, 2014] § 520.88d Amoxicillin trihydrate soluble powder. § 520.88f Amoxicillin trihydrate tablets. (a) Specifications. Each gram of powder contains amoxicillin trihydrate (a) Specifications. Each tablet con- equivalent to 115.4 milligrams (mg) tains amoxicillin trihydrate equivalent amoxicillin. to 50, 100, 200, or 400 milligrams (mg) (b) Sponsor. See No. 054771 in amoxicillin. § 510.600(c) of this chapter. (b) Sponsors. See Nos. 051311 and (c) Related tolerances. See § 556.38 of 054771 in § 510.600(c) of this chapter. this chapter. (c) Conditions of use in dogs—(1) (d) Conditions of use in preruminating Amount. Administer 5 mg per pound of calves including veal calves—(1) Amount. body weight twice daily for 5 to 7 days Administer 400 mg per 100 pounds of or 48 hours after all symptoms have body weight twice daily by drench or in subsided. milk. Treatment should be continued (2) Indications for use. For treatment for 48 hours after all symptoms have of bacterial dermatitis due to Staphy- subsided but not to exceed 5 days. lococcus aureus, Streptococcus spp., (2) Indications for use. Treatment of Staphylococcus spp., and Escherichia bacterial enteritis when due to suscep- coli; and soft tissue infections (ab- tible Escherichia coli in preruminating scesses, wounds, lacerations) due to S. calves including veal calves. aureus, Enterococcus faecalis, E. coli, (3) Limitations. Do not slaughter ani- Proteus mirabilis, and Staphylococcus mals during treatment or for 20 days spp.

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(3) Limitations. Federal law restricts wounds, abscesses and cellulitis/derma- this drug to use by or on the order of a titis due to susceptible strains of beta- licensed veterinarian. lactamase (penicillinase) producing S. [79 FR 28817, May 20, 2014, as amended at 83 aureus, non-beta-lactamase producing FR 64740, Dec. 18, 2018] S. aureus, Staphylococcus spp., Strepto- coccus spp., E. coli, and Pasteurella spp. § 520.88g Amoxicillin trihydrate and Also, treatment of urinary tract infec- clavulanate potassium tablets. tions (cystitis) due to susceptible (a) Specifications. Each tablet or strains of E. coli. chewable tablet contains amoxicillin (iii) Limitations. Federal law restricts trihydrate and clavulanate potassium this drug to use by or on the order of a equivalent to 50 milligrams (mg) of licensed veterinarian. amoxicillin and 12.5 mg clavulanic acid, 100 mg of amoxicillin and 25 mg [57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, clavulanic acid, 200 mg amoxicillin and 1998; 79 FR 28817, May 20, 2014; 80 FR 34278, 50 mg clavulanic acid, or 300 mg June 16, 2015; 82 FR 11508, Feb. 24, 2017; 82 FR amoxicillin and 75 mg clavulanic acid. 43484, Sept. 18, 2017; 82 FR 58556, Dec. 13, 2017] (b) Sponsors. See sponsors in § 510.600(c) of this chapter: § 520.88h Amoxicillin trihydrate and (1) No. 054771 for use of tablets and clavulanate potassium for oral sus- chewable tablets as in paragraph (c) of pension. this section. (a) Specifications. When reconstituted, (2) No. 026637 for use of tablets as in each milliliter contains amoxicillin paragraph (c) of this section. trihydrate equivalent to 50 milligrams (c) Conditions of use—(1) Dogs—(i) of amoxicillin with clavulanate potas- Amount. 6.25 milligrams (equivalent to sium equivalent to 12.5 milligrams of 5 milligrams amoxicillin and 1.25 milli- clavulanic acid. grams clavulanic acid) per pound of (b) Sponsor. See No. 054771 in body weight twice daily for 5 to 7 days § 510.600(c) of this chapter. or for 48 hours after all signs have subsided. Deep pyoderma may require (c) Conditions of use—(1) Dogs—(i) treatment for 21 days; do not treat for Amount. 6.25 milligrams (equivalent to more than 30 days. 5 milligrams amoxicillin and 1.25 milli- (ii) Indications for use. Treatment of grams clavulanic acid) per pound of skin and soft tissue infections such as body weight twice daily for 5 to 7 days wounds, abscesses, cellulitis, super- or for 48 hours after all signs have sub- ficial/juvenile and deep pyoderma due sided. Deep pyoderma may require to susceptible strains of beta- treatment for 21 days; do not treat for lactamase (penicillinase) Staphy- more than 30 days. lococcus aureus, non-beta-lactamase S. (ii) Indications for use. Treatment of aureus, Staphylococcus spp., Strepto- skin and soft tissue infections such as coccus spp., and Escherichia coli. Treat- wounds, abscesses, cellulitis, super- ment of periodontal infections due to ficial/juvenile and deep pyoderma due susceptible strains of aerobic and an- to susceptible strains of beta- aerobic bacteria. lactamase (penicillinase) producing (iii) Limitations. Federal law restricts Staphylococcus aureus, nonbeta- this drug to use by or on the order of a lactamase Staphylococcus aureus, Staph- licensed veterinarian. ylococcus spp., Streptococcus spp., and (2) Cats—(i) Amount. 62.5 milligrams Escherichia coli. Treatment of peri- (50 milligrams amoxicillin and 12.5 mil- odontal infections due to susceptible ligrams clavulanic acid) twice daily for strains of aerobic and anaerobic bac- 5 to 7 days or for 48 hours after all teria. signs have subsided. Urinary tract in- (iii) Limitations. Federal law restricts fections may require treatment for 10 this drug to use by or on the order of a to 14 days or longer. The maximum du- licensed veterinarian. ration of treatment should not exceed (2) Cats—(i) Amount. 62.5 milligrams 30 days. (1 milliliter) (50 milligrams amoxicillin (ii) Indications for use. Treatment of and 12.5 milligrams clavulanic acid) skin and soft tissue infections, such as twice daily. Administer 48 hours after

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all signs have subsided. Maximum du- § 520.90b Ampicillin capsules. ration of treatment should not exceed (a) Specifications. Each capsule con- 30 days. tains ampicillin trihydrate equivalent (ii) Indications for use. Treatment of to 125, 250, or 500 milligrams of ampi- feline skin and soft tissue infections, cillin. such as wounds, abscesses and (b) Sponsor. See No. 054771 in cellulitis/dermatitis due to susceptible § 510.600(c) of this chapter. strains of beta-lactamase (penicil- (c) Conditions of use—(1) Dogs—(i) linase) producing S. aureus, nonbeta- Amount. 5 to 10 milligrams per pound of lactamase S. aureus, Staphylococcus body weight two or three times daily. spp., Streptococcus spp., E. coli, In severe or acute conditions, 10 milli- Pasteurella multocida, and Pasteurella grams per pound of body weight, three spp. times daily. Administer 1 to 2 hours (iii) Limitations. Federal law restricts prior to feeding. this drug to use by or on the order of a (ii) Indications for use. Treatment licensed veterinarian. against strains of gram-negative and [57 FR 37320, Aug. 18, 1992, as amended at 60 gram-positive organisms sensitive to FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, ampicillin and associated with res- 1998; 79 FR 28817, May 20, 2014] piratory tract infections (tracheobronchitis and tonsillitis); uri- § 520.90 Ampicillin oral dosage forms. nary tract infections (cystitis); bacterial gastroenteritis; generalized in- § 520.90a Ampicillin tablets. fections (septicemia) associated with (a) Specifications. Each tablet con- abscesses, lacerations, and wounds; and tains ampicillin trihydrate equivalent bacterial dermatitis. to 50 or 100 milligrams of ampicillin. (iii) Limitations. Federal law restricts (b) Sponsor. See No. 054771 in this drug to use by or on the order of a § 510.600(c) of this chapter. licensed veterinarian. (c) Conditions of use in dogs—(1) (2) Cats—(i) Amount. 10 to 30 milli- Amount. 5 milligrams per pound of body grams per pound of body weight or weight, at 8-hour intervals, 1 to 2 hours three times daily. Administer 1 to 2 prior to feeding, to be continued 36 to hours prior to feeding. 48 hours after all symptoms have sub- (ii) Indications for use. Treatment sided. If no improvement is seen within against strains of gram-negative and 5 days, stop treatment, reevaluate di- gram-positive organisms sensitive to agnosis, and change therapy. ampicillin and associated with res- (2) Indications for use. Oral treatment piratory tract infections (bacterial of infections caused by susceptible or- pneumonia); urinary tract infections ganisms as follows: Upper respiratory (cystitis); and generalized infections infections, tonsillitis, and bronchitis (septicemia) associated with abscesses, due to Streptococcus spp., Staphylococcus lacerations, and wounds. spp., Escherichia coli, Proteus mirabilis, (iii) Limitations. Federal law restricts and Pasteurella spp., urinary tract in- this drug to use by or on the order of a fections (cystitis) due to Streptococcus licensed veterinarian. spp., Staphylococcus spp., E., coli, P. [57 FR 37321, Aug. 18, 1992, as amended at 58 mirabilis, and Enterococcus spp.; gastro- FR 61016, Nov. 19, 1993; 79 FR 28818, May 20, intestinal infections due to Staphy- 2014. Redesignated at 85 FR 18118, Apr. 1, lococcus spp., Streptococcus spp., 2020] Enterococcus spp., and E. coli. ; infections associated with abscesses, lacera- § 520.90c Ampicillin boluses. tions, and wounds caused by Staphy- (a) Specifications. Each bolus contains lococcus spp., and Streptococcus spp. ampicillin trihydrate equivalent to 400 (3) Limitations. Federal law restricts milligrams of ampicillin. this drug to use by or on the order of a (b) Sponsor. See No. 054771 in licensed veterinarian. § 510.600(c) of this chapter. [57 FR 37321, Aug. 18, 1992, as amended at 60 (c) Related tolerances. See § 556.40 of FR 55659, Nov. 2, 1995; 79 FR 28818, May 20, this chapter. 2014. Redesignated at 85 FR 18118, Apr. 1, (d) Conditions of use in nonruminating 2020] calves—(1) Amount. 5 milligrams per

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pound of body weight twice daily not (i) Indications for use and amounts— to exceed 4 days. (A) As an aid in the prevention of coc- (2) Indications for use. Oral treatment cidiosis caused by Eimeria bovis and E. of bacterial enteritis (colibacillosis) zurnii, administer 5 mg per kilogram caused by E. coli. (mg/kg) body weight for 21 days during (3) Limitations. Treated calves must periods of exposure or when experience not be slaughtered for food during indicates that coccidiosis is likely to treatment and for 7 days after the last be a hazard. treatment. Federal law restricts this (B) As an aid in the treatment of coc- drug to use by or on the order of a li- cidiosis caused by E. bovis and E. zurnii, censed veterinarian. administer 10 mg/kg body weight for 5 days. [57 FR 37322, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993; 60 FR 55659, Nov. 2, (ii) Limitations. Withdraw 24 hours be- 1995; 79 FR 28818, May 20, 2014. Redesignated fore slaughter. A withdrawal period has and amended at 85 FR 18118, Apr. 1, 2020] not been established for this product in preruminating calves. Do not use in § 520.100 Amprolium. calves to be processed for veal. Use as (a) Specifications. (1) Each milliliter the sole source of amprolium. of solution contains 96 milligrams (mg) [71 FR 56346, Sept. 27, 2006, as amended at 72 amprolium (9.6 percent solution). FR 60551, Oct. 25, 2007; 73 FR 45611, Aug. 6, (2) Each gram of powder contains 200 2008; 73 FR 70276, Nov. 20, 2008; 74 FR 10484, mg amprolium (20 percent). Mar. 11, 2009; 76 FR 38554, July 1, 2011; 76 FR (3) Each ounce (28.4 grams) of crum- 40808, July 12, 2011; 78 FR 23, Jan. 2, 2013; 78 bles contains 355 mg amprolium (1.25 FR 17596, Mar. 22, 2013; 78 FR 57058, Sept. 17, percent). 2013; 81 FR 22523, Apr. 18, 2016; 81 FR 59133, (b) Sponsors. See sponsors in 510.600(c) Aug. 29, 2016; 84 FR 8972, Mar. 13, 2019] of this chapter. § 520.110 Apramycin sulfate soluble (1) Nos. 016592 and 061133 for use of powder. products described in paragraph (a) of this section as in paragraph (d) of this (a) Specifications. A water soluble section. powder used to make a medicated (2) Nos. 051072 and 066104 for use of drinking water containing apramycin product described in paragraph (a)(1) of sulfate equivalent to 0.375 gram of this section as in paragraph (d) of this apramycin activity per gallon of drink- section. ing water. (c) Related tolerances. See § 556.50 of (b) Sponsor. See No. 058198 in this chapter. § 510.600(c) of this chapter. (d) Conditions of use—(1) Growing (c) Related tolerances. See § 556.52 of chickens, turkeys, and laying hens. It is this chapter. used in drinking water as follows: (d) Conditions of use in swine—(1) (i) Amount. Administer at the 0.012 Amount. Administer in drinking water percent level in drinking water as soon at the rate of 12.5 milligrams of as coccidiosis is diagnosed and con- apramycin per kilogram (5.7 milli- tinue for 3 to 5 days (in severe out- grams per pound) of body weight per breaks, give amprolium at the 0.024 day for 7 days. percent level); continue with 0.006 per- (2) Indications for use. For the control cent amprolium-medicated water for of porcine colibacillosis (weanling pig an additional 1 to 2 weeks. scours) caused by strains of Escherichia (ii) Indications for use. For the treat- coli sensitive to apramycin. ment of coccidiosis. (3) Limitations. Do not slaughter (iii) Limitations. Use as the sole treated swine for 28 days following source of amprolium. treatment. Federal law restricts this (2) Calves. Administer crumbles top- drug to use by or on the order of a li- dressed on or thoroughly mixed in the censed veterinarian. daily feed ration; administer con- [47 FR 15771, Apr. 13, 1982, as amended at 49 centrate solution or soluble powder as FR 19642, May 9, 1984; 53 FR 37753, Sept. 28, a drench or in drinking water as fol- 1988; 79 FR 28818, May 20, 2014; 81 FR 48702, lows: July 26, 2016; 81 FR 94989, Dec. 27, 2016]

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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 tridium colinum susceptible to baci- methylenedisalicylate. tracin methylenedisalicylate. (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; 79 FR 28818, May 20, 2014; 80 FR (b) Sponsor. See No. 054771 in 34278, June 16, 2015] § 510.600(c) of this chapter. (c) Related tolerances. See § 556.70 of § 520.154b Bacitracin this chapter. methylenedisalicylate and streptomycin sulfate powder. (d) Conditions of use—(1) Growing turkeys—(i) Amount. 400 milligrams (mg) (a) Specifications. Each gram of pow- per gallon (gal) in drinking water. der contains 200 units bacitracin (ii) Indications for use. Aid in the con- methylenedisalicylate and strepto- trol of transmissible enteritis com- mycin sulfate equivalent to 20 milli- plicated by organisms susceptible to grams of streptomycin. bacitracin methylenedisalicylate. (b) Sponsor. See No. 054771 in (iii) Limitations. Prepare a fresh solu- § 510.600(c) of this chapter. tion daily. (c) Conditions of use in dogs—(1) (2) Broiler and replacement chickens— Amount. Administer 1 level teaspoonful (i) Amount. 100 mg per gal in drinking per 10 pounds of body weight three water. times daily, mixed in a small quantity (A) Indications for use. Aid in the pre- of liquid or feed. vention of necrotic enteritis caused by (2) Indications for use. For the treat- Clostridium perfringens susceptible to ment of bacterial enteritis caused by bacitracin methylenedisalicylate. pathogens susceptible to bacitracin and (B) Limitations. Prepare a fresh solu- streptomycin such as Escherichia coli, tion daily. Proteus spp., Staphylococcus spp., and (ii) Amount. 200 to 400 mg per gal in Streptococcus spp., and for the sympto- drinking water. Administer continu- matic treatment of associated diar- ously 5 to 7 days or as long as clinical rhea. signs persist, then reduce to prevention (3) Limitations. Federal law restricts levels (100 mg/gal). this drug to use by or on the order of a (A) Indications for use. Treatment of licensed veterinarian. necrotic enteritis caused by C. [71 FR 17702, Apr. 7, 2006, as amended at 79 perfringens susceptible to bacitracin FR 28818, May 20, 2014; 81 FR 17607, Mar. 30, methylenedisalicylate. 2016] (B) Limitations. Prepare a fresh solution daily. § 520.154c Bacitracin zinc soluble pow- (3) Swine—(i) Amount. 1 gram per gal- der. lon in drinking water. (a) Specifications. Each pound con- (ii) Indications for use. Treatment of tains the equivalent of not less than 5 swine dysentery associated with grams of bacitracin. Brachyspira hyodysenteriae. Administer (b) Sponsor. See No. 054771 in continuously for 7 days or until signs § 510.600(c) of this chapter. of dysentery disappear. (c) Related tolerances. See § 556.70 of (iii) Limitations. Prepare a fresh solu- this chapter. tion daily. Treatment not to exceed 14 (d) Conditions of use—(1) Broiler chick- days. If symptoms persist after 4 to 5 ens—(i) Amount. 100 milligrams per gal- days consult a veterinarian. Not to be lon in drinking water. given to swine that weigh more than (A) Indications for use. Prevention of 250 pounds. necrotic enteritis caused by Clostridium (4) Growing quail—(i) Amount. 400 mg perfringens susceptible to bacitracin per gal in drinking water. zinc.

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

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treatment. Puppies and kittens should followed in 1⁄2 to 1 hour with a mild ca- be given a repeat treatment in a week thartic. Normal feeding may be re- or 10 days. After that they should be sumed 4 to 8 hours after treatment. treated every 2 months (or as symp- Animals subject to reinfection may be toms reappear) until a year old. When retreated in 2 weeks. the puppy or kitten is a year old, one (b) The drug is administered orally to treatment every 3 to 6 months is suffi- dogs. Capsules containing 221 milli- cient. grams of n-butyl chloride are adminis- (b) For dogs or cats that have been tered to dogs weighing under 5 pounds wormed regularly, treatment every 3 to at a dosage level of 1 capsule per 11⁄4 6 months will be sufficient. If a dog or pound of body weight. Capsules con- cat has not been wormed previously taining 442 milligrams of n-butyl chlo- and has the symptoms of large ride are administered to dogs weighing roundworms a dose should be given and under 5 pounds at a dosage level of 1 repeated in 10 days. Removal of capsule per 21⁄2 pounds body weight. hookworms may require 3 or 4 doses at Capsules containing 884 milligrams of 10-day intervals. n-butyl chloride are administered to (c) Puppies, dogs, cats, or kittens dogs as follows: Weighing under 5 weighing 1 to 3 pounds should be given pounds, 1 capsule; weighing 5 to 10 2 capsules per dose which contain 272 pounds, 2 capsules; weighing 10 to 20 milligrams of n-butyl chloride each. pounds, 3 capsules; weighing 20 to 40 Such animals weighing 4 to 5 pounds pounds, 4 capsules; over 40 pounds, 5 should be given 3 such capsules. Ani- capsules. Capsules containing 1,768 mil- mals weighing 6 to 7 pounds should be ligrams of n-butyl chloride are admin- given 4 such capsules and animals istered at a dosage level of 1 capsule weighing 8 to 9 pounds should be given per dog weighing 5 to 10 pounds. Cap- 5 such capsules. Animals weighing 10 to sules containing 4.42 grams of n-butyl 20 pounds should be given 3 capsules chloride are administered at a dosage which contain 816 milligrams of n- level of 1 capsule per dog weighing 40 butyl chloride each, animals weighing pounds or over. 20 to 40 pounds should be given 4 such (iii) A veterinarian should be con- capsules and animals weighing over 40 sulted before using in severely debili- pounds should be given 5 such capsules tated dogs. with the maximum dosage being 5 capsules, each of which contains 816 milli- [40 FR 13838, Mar. 27, 1975, as amended at 40 grams of n-butyl chloride. FR 39858, Aug. 29, 1975; 44 FR 10059, Feb. 16, 1979; 54 FR 38515, Sept. 19, 1989; 55 FR 24556, (iii) A veterinarian should be con- June 18, 1990; 64 FR 15684, Apr. 1, 1999; 70 FR sulted before using in severely debili- 50182, Aug. 26, 2005; 78 FR 14669, Mar. 7, 2013; tated dogs or cats and also prior to re- 79 FR 28818, May 20, 2014; 85 FR 18119, Apr. 1, peated use in cases which present signs 2020] of persistent parasitism. EDITORIAL NOTE: At 78 FR 14669, Mar. 7, (b)(1) Specifications. n-Butyl chloride 2013, § 520.260 was amended by adding para- capsules contain 221, 442, 884, or 1,768 graphs (b)(1) through (3); however, the milligrams or 4.42 grams of n-butyl amendment could not be incorporated be- chloride in each capsule. cause (b)(1) through (3) already existed. (2) Sponsors. See No. 023851 in § 510.600(c) of this chapter for 221, 442, § 520.284 Cambendazole oral dosage 884, or 1,768 milligram or 4.42 gram cap- forms. sules; and No. 054771 for 221 milligram § 520.284a Cambendazole suspension. capsules. (3) Conditions of use. (i) It is used for (a) Specifications. Each fluid ounce the removal of ascarids (Toxocara canis contains 0.9 gram of cambendazole. and Toxascaris leonina) and hookworms (b) Sponsor. No. 000010 in § 510.600(c) of (Ancylostoma caninum, Ancylostoma this chapter. braziliense, and Uncinaria stenocephala) (c) Conditions of use in horses—(1) from dogs. Amount. Administer by stomach tube (ii)(a) Dogs should not be fed for 18 to or as a drench at a dose of 0.9 gram of 24 hours before being given the drug. cambendazole per 100 pounds of body Administration of the drug should be weight (20 milligrams per kilogram).

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(2) Indications for use. For the control § 520.284c Cambendazole paste. of large strongyles (Strongylus vulgaris, (a) Specifications. The drug is a paste S. edentatus, S. equinus); small containing 45 percent cambendazole. strongyles (Trichonema, Poteriostomum, (b) Sponsor. No. 000010 in § 510.600(c) of Cylicobrachytus, Craterostomum, this chapter. Oesophagodontus); roundworms (c) Conditions of use in horses—(1) (Parascaris); pinworms (Oxyuris); and Amount. Administer 20 milligrams threadworms (Strongyloides). cambendazole per kilogram body (3) Limitations. Do not use in horses weight (5 grams per 550 pounds (250 intended for human consumption. Fed- kilograms)) by depositing the paste on eral law restricts this drug to use by or the back of the tongue using a dosing on the order of a licensed veterinarian. gun. For animals maintained on premises where reinfection is likely to [40 FR 13838, Mar. 27, 1975. Redesignated at 41 FR 1276, Jan. 7, 1976, and amended at 42 FR occur, re-treatments may be necessary. 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997; For most effective results, re-treat in 6 79 FR 28818, May 20, 2014. Redesignated at 81 to 8 weeks. FR 59133, Aug. 29, 2016; 84 FR 39182, Aug. 9, (2) Indications for use. For the control 2019] of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small § 520.284b Cambendazole pellets. strongyles (Trichonema, Poteriostomum, (a) Specifications. The drug is in feed Cylicobrachytus, Craterostomum, pellets containing 5.3 percent Oesophagodontus); roundworms cambendazole. (Parascaris); pinworms (Oxyuris); and threadworms (Strongyloides). (b) Sponsor. No. 000010 in § 510.600(c) of (3) Limitations. Do not administer to this chapter. pregnant mares during first 3 months (c) Conditions of use in horses—(1) of pregnancy. Do not use in horses in- Amount. Administer 20 milligrams tended for human consumption. Con- cambendazole per kilogram body sult your veterinarian for assistance in weight (6 ounces per 1,000 pounds) by the diagnosis, treatment, and control mixing with normal grain ration given of parasitism. at one feeding. Doses for individual horses should be mixed and fed sepa- [41 FR 1276, Jan. 7, 1976, as amended at 42 FR rately to assure that each horse will 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997; 79 FR 28819, May 20, 2014. Redesignated at 81 consume the correct amount. For ani- FR 59133, Aug. 29, 2016; 84 FR 39182, Aug. 9, mals maintained on premises where re- 2019] infection is likely to occur, re-treatments may be necessary. For most ef- § 520.292 Capromorelin. fective results, re-treat in 6 to 8 weeks. (a) Specifications. Each milliliter of (2) Indications for use. For the control solution contains 30 milligrams (mg) of large strongyles (Strongylus vulgaris, capromorelin. S. edentatus, S. equinus); small (b) Sponsor. See No. 058198 in strongyles (Trichonema, Poteriostomum, § 510.600(c) of this chapter. Cylicobrachytus, Craterostomum, (c) Conditions of use in dogs—(1) Oesophagodontus); roundworms Amount. Administer 3 mg/kg once daily (Parascaris); pinworms (Oxyuris); and by mouth. threadworms (Strongyloides). (2) Indications for use. For appetite (3) Limitations. Do not administer to stimulation in dogs. pregnant mares during first 3 months (3) Limitations. Federal law restricts of pregnancy. Do not use in horses in- this drug to use by or on the order of a tended for human consumption. Con- licensed veterinarian. sult your veterinarian for assistance in [81 FR 59133, Aug. 29, 2016, as amended at 85 the diagnosis, treatment, and control FR 4207, Jan. 24, 2020] of parasitism. § 520.301 Caramiphen [41 FR 1276, Jan. 7, 1976, as amended at 42 FR ethanedisulfonate and ammonium 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997; chloride tablets. 79 FR 28818, May 20, 2014. Redesignated at 81 FR 59133, Aug. 29, 2016; 84 FR 39182, Aug. 9, (a) Specifications. Each tablet con- 2019] tains 10 milligrams of 5st caramiphen

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ethanedisulfonate and 80 milligrams of osteoarthritis and for the control of ammonium chloride. postoperative pain associated with soft (b) Sponsor. See No. 054771 in tissue and orthopedic surgeries. § 510.600(c) of this chapter. (3) Limitations. Federal Law restricts (c) Conditions of use in dogs—(1) this drug to use by or on the order of a Amount. One tablet per 15 to 30 pounds licensed veterinarian. of body weight every 4 to 6 hours. (2) Indications for use. For relief of [61 FR 66581, Dec. 18, 1996, as amended at 64 FR 32181, June 16, 1999; 66 FR 63165, Dec. 5, cough. 2001; 67 FR 6866, Feb. 14, 2002; 67 FR 65038, [43 FR 55385, Nov. 28, 1978, as amended at 79 Oct. 23, 2002; 67 FR 65697, Oct. 28, 2002; 70 FR FR 28819, May 20, 2014. Redesignated at 80 FR 30626, May 27, 2005; 71 FR 51995, Sept. 1, 2006; 13229, Mar. 13, 2015] 72 FR 68478, Dec. 5, 2007; 74 FR 21768, May 11, 2009; 78 FR 52853, Aug. 27, 2013; 78 FR 66264, § 520.302 Carnidazole tablets. Nov. 5, 2013; 79 FR 28819, May 20, 2014. Redes- ignated and amended at 80 FR 13229, Mar. 13, (a) Specifications. Each tablet con- 2015; 80 FR 34278, June 16, 2015; 80 FR 61296, tains 10 milligrams of carnidazole. Oct. 13, 2015; 82 FR 43484, Sept. 18, 2017; 84 FR (b) Sponsor. See 053923 in § 510.600(c) of 12493, Apr. 2, 2019; 85 FR 4207, Jan. 24, 2020] this chapter. (c) Conditions of use—(1) Amount. § 520.314 Cefadroxil. Adult pigeons: 1 tablet (10 milligrams); (a) Specifications. (1) Each tablet con- 1 newly weaned pigeons: ⁄2 tablet (5 mil- tains 50, 100, or 200 milligrams (mg) or ligrams). 1 gram of cefadroxil. (2) Indications for use. For treating (2) Each milliliter of suspension con- trichomoniasis (canker) in ornamental stituted from powder contains 50 mg of and homing pigeons. cefadroxil. (3) Limitations. Not for use in pigeons (b) Sponsor. See No. 000010 in intended for human food. Consult your § 510.600(c) of this chapter. veterinarian for assistance in the diag- (c) Conditions of use in dogs and cats— nosis, treatment, and control of para- (1) Amount—(i) Dogs. Administer 10 mg sitism or when severely ill birds do not per pound (/lb) body weight twice daily respond to treatment. orally. [54 FR 32336, Aug. 7, 1989. Redesignated at 80 (ii) Cats. Administer 10 mg/lb body FR 13229, Mar. 13, 2015] weight once daily orally. (2) Indications for use—(i) Dogs. For § 520.304 Carprofen. the treatment of skin and soft tissue (a) Specifications. (1) Each caplet con- infections including cellulitis, tains 25, 75, or 100 milligrams (mg) pyoderma, dermatitis, wound infec- carprofen. tions, and abscesses due to susceptible (2) Each chewable tablet contains 25, strains of Staphylococcus aureus. For 75, or 100 mg carprofen. the treatment of genitourinary tract (b) Sponsors. See sponsors in infections (cystitis) due to susceptible § 510.600(c) of this chapter for uses as in strains of Escherichia coli, Proteus paragraph (d) of this section. mirabilis, and S. aureus. (1) Nos. 026637, 054771, 055529, and (ii) Cats. For the treatment of skin 062250 for use of products described in and soft tissue infections including ab- paragraph (a) as in paragraph (d) of scesses, wound infections, cellulitis, this section. and dermatitis caused by susceptible (2) No. 000859 for use of product de- strains of Pasteurella multocida, S. scribed in paragraph (a)(1) as in para- aureus, Staphylococcus epidermidis, and graph (d) of this section. Streptococcus spp. (c) [Reserved] (3) Limitations. Federal law restricts (d) Conditions of use in dogs—(1) this drug to use by or on the order of a Amount. 2 mg per pound (/lb) of body licensed veterinarian. weight once daily or 1 mg/lb twice daily. For the control of postoperative [75 FR 10165, Mar. 5, 2010] pain, administer approximately 2 hours before the procedure. § 520.370 Cefpodoxime tablets. (2) Indications for use. For the relief of (a) Specifications. (1) Each tablet con- pain and inflammation associated with tains cefpodoxime proxetil equivalent

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to 100 or 200 milligrams (mg) § 520.390 Chloramphenicol oral dosage cefpodoxime. forms. (2) Each chewable tablet contains cefpodoxime proxetil equivalent to 100 § 520.390a Chloramphenicol tablets. or 200 mg cefpodoxime. (a) Specifications. Each tablet con- (b) Sponsors. See sponsors in tains 50, 100, 250, or 500 milligrams § 510.600(c) of this chapter for uses as (mg); 1 or 2.5 grams (g) of chloramphen- follows: icol. (1) No. 026637 for use of product in (b) Sponsors. See § 510.600(c) of this paragraph (a)(1) of this section as in chapter: paragraph (c) of this section. (1) For use as in paragraphs (c)(1), (2) No. 054771 for use of products in (c)(2)(i), and (c)(3) of this section: paragraph (a) of this section as in para- (i) No. 069043 for 100-, 250-, and 500-mg; graph (c) of this section. and 1- and 2.5-g tablets; (c) Conditions of use in dogs—(1) (ii) No. 054771 for 100-, 250-, and 500- Amount. 5 to 10 mg per kilogram (2.3 to mg tablets; 4.5 mg per pound) body weight daily for (2) For use as in paragraphs (c)(1), 5 to 7 days, or for 2 to 3 days beyond (c)(2)(ii), and (c)(3) of this section: the cessation of clinical signs, up to a (i) No. 061133 for 50-, 100-, 250-, and maximum of 28 days. 500-mg; and 1-g tablets; (2) Indications for use. For the treat- (ii) [Reserved] ment of skin infections (wounds and (c) Conditions of use in dogs—(1) abscesses) caused by susceptible strains Amount. Administer 25 mg per pound of of Staphylococcus pseudintermedius, S. body weight by mouth every 6 hours. aureus, Streptococcus canis (group G, (2) Indications for use—(i) For the beta-hemolytic), Escherichia coli, treatment of bacterial pulmonary in- Pasteurella multocida, and Proteus fections, bacterial infections of the uri- mirabilis. nary tract, bacterial enteritis, and bac- (3) Limitations. Federal law restricts terial infections associated with canine this drug to use by or on the order of a distemper caused by susceptible orga- licensed veterinarian. nisms. (ii) For the treatment of bacterial [69 FR 52815, Aug. 30, 2004, as amended at 78 FR 5714, Jan. 28, 2013; 79 FR 28819, May 20, gastroenteritis associated with bac- 2014; 80 FR 13229, Mar. 13, 2015; 82 FR 12169, terial diarrhea, bacterial pulmonary Mar. 1, 2017] infections, and bacterial infections of the urinary tract caused by susceptible § 520.376 Cephalexin. organisms. (a) Specifications. Each chewable tab- (3) Limitations. Federal law restricts let contains 75, 150, 300, or 600 milli- this drug to use by or on the order of a licensed veterinarian. Federal law programs (mg) cephalexin. hibits the extralabel use of this drug in (b) See No. 051311 in Sponsor. food-producing animals. § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) [77 FR 4896, Feb. 1, 2012, as amended at 78 FR Amount. Administer 22 mg per kilo- 21059, Apr. 9, 2013; 79 FR 28819, May 20, 2014; gram of body weight twice daily for 28 83 FR 48944, Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019] days. (ii) Indications for use. For the treat- § 520.390b Chloramphenicol capsules. ment of secondary superficial bacterial pyoderma in dogs caused by susceptible (a) Specifications. Each capsule con- strains of Staphylococcus tains 50, 100, 250, or 500 milligrams (mg) pseudintermedius. chloramphenicol. (iii) Limitations. Federal law restricts (b) Sponsors. See Nos. 050057 and this drug to use by or on the order of a 054771 in § 510.600(c) of this chapter for use as in paragraph (d) of this section. licensed veterinarian. (c) Special considerations. Federal law (2) [Reserved] prohibits the extralabel use of this [77 FR 47512, Aug. 9, 2012] product in food-producing animals.

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(d) Conditions of use in dogs—(1) (ii) Indications for use. For treatment Amount. 25 mg per pound of body of congestive heart failure and renal weight every 6 hours. edema. (2) Indications for use. For treatment (iii) Limitations. Federal law restricts of bacterial pulmonary infections, bac- this drug to use by or on the order of a terial infections of the urinary tract, licensed veterinarian. bacterial enteritis, and bacterial infec- (2) Cows—(i)—Amount. Administer 2 tions associated with canine distemper grams once or twice daily for 3 or 4 caused by susceptible organisms. days. (3) Limitations. Federal law restricts (ii) Indications for use. As an aid in re- this drug to use by or on the order of a duction of postparturient udder edema. licensed veterinarian. (iii) Limitations. Milk taken from dairy animals during treatment and for [70 FR 75398, Dec. 20, 2005, as amended at 73 FR 18442, Apr. 4, 2008; 75 FR 55676, Sept. 14, 72 hours (six milkings) after latest 2010; 79 FR 28819, May 20, 2014] treatment must not be used for food. Federal law restricts this drug to use § 520.390c Chloramphenicol palmitate by or on the order of a licensed veteri- oral suspension. narian. (a) Specifications. Each milliliter con- [84 FR 39183, Aug. 9, 2019] tains chloramphenicol palmitate equivalent to 30 milligrams of chloramphen- § 520.434 Chlorphenesin carbamate icol. tablets. (b) Sponsor. See No. 054771 in (a) Specifications. Each tablet con- § 510.600(c) of this chapter. tains 400 milligrams of chlorphenesin (c) Conditions of use. Dogs—(1) carbamate. Amount. 25 milligrams per pound of (b) Sponsor. See No. 054771 in body weight every 6 hours. If no re- § 510.600(c) of this chapter. sponse is obtained in 3 to 5 days, dis- (c) Conditions of use in dogs—(1) continue use and reevaluate diagnosis. Amount. 50 milligrams per pound of (2) Indications for use. Treatment of body weight on first day; 25 milligrams bacterial pulmonary infections, infec- per pound of body weight each fol- tions of the urinary tract, enteritis, lowing day. Divide total daily dose into and infections associated with canine 2 or 3 equal doses—administer at 12- or distemper that are caused by orga- 8-hour intervals. nisms susceptible to chloramphenicol. (2) Indications for use. For use as an (3) Limitations. Not for use in animals adjunct to therapy of acute inflam- that are raised for food production. matory and traumatic conditions of Must not be used in meat-, egg-, or skeletal muscles. The drug provides re- milk-producing animals. The length of lief of the signs of discomfort associ- time that residues persist in milk or ated with myositis, muscle sprains, tissues has not been determined. Fed- traumatic injuries, stifle injuries—es- eral law restricts this drug to use by or pecially when administered before or on the order of a licensed veterinarian. after surgery—and invertebral disc syndrome (can be used concurrently [57 FR 37323, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 79 FR 28819, May 20, with adrenal corticosteroids). 2014] (3) Limitations. Federal law restricts this drug to use by or on the order of a § 520.420 Chlorothiazide. licensed veterinarian. (a) Specifications. (1) Each tablet con- [44 FR 16009, Mar. 16, 1979, as amended at 79 tains 0.25 grams chlorothiazide. FR 28819, May 20, 2014] (2) Each bolus contains 2 grams chlorothiazide. § 520.441 Chlortetracycline powder. (b) Sponsor. See No. 000010 in (a) Specifications. Chlortetracycline § 510.600(c) of this chapter. powder contains not less than 15 milli- (c) Conditions of use—(1) Dogs—(i) grams per gram chlortetracycline hy- Amount. Administer 5 to 10 milligrams drochloride, or chlortetracycline bisul- per pound of body weight two or three fate equivalent to 25.6, 64 or 102.4 grams times daily. per pound (56.4, 141 or 225.6 milligrams

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per gram) chlortetracycline hydro- not been established in preruminating chloride. calves; do not use in calves to be proc- (b) Sponsors. See sponsors in essed for veal. 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 (d) of this section. licensed veterinarian. (1) Nos. 000010, 016592, 054771, and (B) [Reserved] 069254 for use as in paragraph (d) of this (ii) [Reserved] section. (3) [Reserved] (2) No. 066104 for use as in paragraphs (4) The following uses of chlortetra- (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) cycline hydrochloride or chlortetra- through (d)(4)(iv) of this section. cycline bisulfate in drinking water or (3) Nos. 069043, 069254, and 076475 for drench were reviewed by the National use as in paragraphs (d)(4)(i)(A), Academy of Sciences/National Re- (d)(4)(i)(B), (d)(4)(ii), and (d)(4)(iii) of search Council (NAS/NRC) and found this section. effective: (c) Related tolerances. See § 556.150 of (i) Chickens—(A) Amount. 200 to 400 this chapter. milligrams per gallon. (d) Conditions of use. (1) Use as chlor- (1) Indications for use. Control of in- tetracycline hydrochloride in drinking fectious synovitis caused by Myco- water as follows: plasma synoviae. (i) Swine—(A) Amount. Ten milli- (2) Limitations. Prepare fresh solution grams per pound of body weight daily daily; as sole source of chlortetra- in divided doses. cycline; do not use for more than 14 (1) Indications for use. Control and days; do not slaughter animals for food treatment of bacterial enteritis within 24 hours of treatment; do not (scours) caused by Escherichia coli and use in laying chickens. Federal law re- bacterial pneumonia associated with stricts this drug to use by or on the Pasteurella spp., Actinobacillus order of a licensed veterinarian. pleuropneumoniae (Haemophilus spp.), (B) Amount. 400 to 800 milligrams per and Klebsiella spp. gallon. (2) Limitations. Prepare a fresh solu- (1) Indications for use. Control of tion twice daily; as sole source of chronic respiratory disease and air-sac chlortetracycline; administer for not infections caused by M. gallisepticum more than 5 days. Federal law restricts and E. coli. this drug to use by or on the order of a (2) Limitations. Prepare fresh solution licensed veterinarian. daily; as sole source of chlortetra- (B) [Reserved] cycline; do not use for more than 14 (ii) [Reserved] days; do not slaughter animals for food (2) Use as chlortetracycline hydro- within 24 hours of treatment; do not chloride in a drench or drinking water use in laying chickens. Federal law re- as follows: stricts this drug to use by or on the (i) Calves—(A) Amount. Ten milli- order of a licensed veterinarian. grams per pound of body weight daily (C) Amount. One thousand milligrams in divided doses. per gallon. (1) Control and treatment of bac- (1) Indications for use. Control of mor- terial enteritis (scours) caused by E. tality due to fowl cholera caused by coli and bacterial pneumonia (shipping Pasteurella multocida susceptible to fever) associated with Pasteurella spp., chlortetracycline. A. pleuropneumoniae (Haemophilus spp.), (2) Limitations. See paragraph and Klebsiella spp. (d)(4)(i)(A)(2) of this section. (2) Limitations. Prepare fresh solution (ii) Growing turkeys—(A) Amount. 400 daily; as sole source of chlortetra- milligrams per gallon. cycline; administer for not more than 5 (1) Indications for use. Control of in- days; do not slaughter animals for food fectious synovitis caused by M. within 24 hours of treatment; do not synoviae. administer this product with milk or (2) Limitations. Prepare fresh solution milk replacers; administer 1 hour be- daily; as sole source of chlortetra- fore or 2 hours after feeding milk or cycline; do not use for more than 14 milk replacers; a withdrawal period has days; do not slaughter animals for food

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

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(2) Limitations. As in paragraph (c) Related tolerances. See § 556.150 of (d)(5)(ii)(A)(2) of this section. this chapter. (iii) Swine—(A) Amount. 10 mg/lb body (d) Conditions of use in calves—(1) weight daily, for 3 to 5 days. Amount. One 250 milligram bolus per 50 (B) Indications for use. Control and pounds of body weight twice a day for treatment of bacterial enteritis 3 to 5 days. (scours) caused by E. coli and Sal- (i) Indications for use. Treatment of monella spp., and bacterial pneumonia bacterial enteritis (scours) caused by associated with Pasteurella spp., A. Escherichia coli and bacterial pneu- pleuropneumoniae, and Klebsiella spp. monia associated with Pasteurella spp., susceptible to chlortetracycline. Klesbsiella spp., and Haemophilus spp. (C) Limitations. Prepare fresh solution daily; use as the sole source of chlor- (ii) Limitations. Administer bolus di- tetracycline; do not use for more than rectly by mouth or crush and dissolve 5 days; do not administer to swine in milk or water for drenching or buck- within 24 hours of slaughter. Federal et feeding; if no improvement is noted law restricts this drug to use by or on after 3 days of treatment, consult a the order of a licensed veterinarian. veterinarian; do not use for more than (iv) Calves, beef cattle, and nonlac- 5 days; do not administer within 24 tating dairy cattle—(A) Amount. 10 mg/lb hours of slaughter. body weight daily in divided doses, for (2) Amount. One 25 milligram tablet 3 to 5 days. for each 5 pounds of body weight every (B) Indications for use. Control and 12 hours daily for 3 to 5 days. treatment of bacterial enteritis (i) Indications for use. Control and (scours) caused by Escherichia coli and treatment of bacterial enteritis Salmonella spp., and bacterial pneu- (scours) caused by E. coli and Sal- monia associated with Pasteurella spp., monella spp. and bacterial pneumonia Histophilus spp., and Klebsiella spp. sus- associated with Pasteurella spp., ceptible to chlortetracycline. Haemophilus spp., and Klebsiella spp., (C) Limitations. Prepare fresh solution susceptible to chlortetracycline. daily; use as a drench; use as the sole source of chlortetracycline; do not use (ii) Limitations. Administer tablet di- for more than 5 days; do not administer rectly by mouth or crush and dissolve to cattle within 24 hours of slaughter; in water for drenching; if no improve- do not use in lactating dairy cattle; do ment is noted after 3 days of treat- not administer this product with milk ment, consult a veterinarian; do not or milk replacers; administer 1 hour use for more than 5 days; when feeding before or 2 hours after feeding milk or milk or milk replacer, administration 1 milk replacers; a withdrawal period has hour before or 2 hours after feeding; do not been established in preruminating not administer within 24 hours of calves; do not use in calves to be proc- slaughter. essed for veal. Federal law restricts (3) Amount. One 500 milligram bolus this drug to use by or on the order of a per 100 pounds of body weight twice a licensed veterinarian. day for 3 to 5 days. [57 FR 37324, Aug. 18, 1992] (i) Indications for use. Treatment of bacterial enteritis (scours) caused by E. EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 520.441, see the List of CFR coli and Salmonella spp., and bacterial Sections Affected, which appears in the pneumonia associated with Pasteurella Finding Aids section of the printed volume spp., Haemophilus spp., and Klebsiella and at www.govinfo.gov. spp., susceptible to chlortetracycline. (ii) Limitations. Administer directly § 520.443 Chlortetracycline tablets and boluses. by mouth or crush and dissolve in 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. (b) Sponsor. See Nos. 016592 and 069043 in § 510.600(c) of this chapter.

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than 5 days; do not administer within (1) Nos. 054771 and 069043 for use of 24 hours of slaughter. capsules described in paragraph (a)(1) of this section. [57 FR 37325, Aug. 18, 1992, as amended at 67 (2) No. 051311 for use of tablets de- FR 78355, Dec. 24, 2002. Redesignated and amended at 76 FR 49649, Aug. 11, 2011; 78 FR scribed in paragraph (a)(2) of this sec- 21059, Apr. 9, 2013; 81 FR 17607, Mar. 30, 2016; tion. 83 FR 48944, Sept. 28, 2018] (3) No. 043806 for use of tablets described in paragraph (a)(3) of this sec- § 520.445 Chlortetracycline and tion. sulfamethazine powder. (c) Conditions of use in dogs—(1) (a) Specifications. Each pound of solu- Amount. Wounds, abscesses, and dental ble powder contains chlortetracycline infections: 2.5 to 15 mg per pound (/lb) bisulfate equivalent to 102.4 grams (g) body weight every 12 hours for a max- of chlortetracycline hydrochloride and imum of 28 days. Osteomyelitis: 5.0 to sulfamethazine bisulfate equivalent to 15 mg/lb body weight every 12 hours for 102.4 g of sulfamethazine. a minimum of 28 days. (2) Indications for use. For the treat- (b) Sponsor. See No. 016592 in ment of skin infections (wounds and § 510.600(c) of this chapter. abscesses) due to susceptible strains of (c) Related tolerances. See §§ 556.150 coagulase-positive staphylococci and 556.670 of this chapter. (Staphylococcus aureus or S. (d) Conditions of use in swine. Admin- intermedius), deep wounds and abscesses ister in drinking water as follows: due to susceptible strains of Bacteroides (1) Amount. 250 milligrams (mg) of fragilis, Prevotella melaninogenicus, chlortetracycline and 250 mg of Fusobacterium necrophorum, and Clos- sulfamethazine per gallon. tridium perfringens, dental infections (2) Indications for use. For the preven- due to susceptible strains of S. aureus, tion and treatment of bacterial enter- B. fragilis, P. melaninogenicus, F. itis; as an aid in the reduction of the necrophorum, and C. perfringens, and os- incidence of cervical abscesses; and as teomyelitis due to susceptible strains an aid in the maintenance of weight of S. aureus, B. fragilis, P. gains in the presence of bacterial en- melaninogenicus, F. necrophorum, and C. teritis and atrophic rhinitis. perfringens. (3) Limitations. Use as the sole source (3) Limitations. Federal law restricts of chlortetracycline and sulfonamide. this drug to use by or on the order of a Not to be used for more than 28 con- licensed veterinarian. secutive days. Withdraw 15 days before [67 FR 54954, Aug. 27, 2002, as amended at 68 slaughter. Federal law restricts this FR 55824, Sept. 29, 2003; 69 FR 32273, June 9, drug to use by or on the order of a li- 2004; 71 FR 39204, July 12, 2006; 73 FR 4077, censed veterinarian. Jan. 24, 2008; 78 FR 17596, Mar. 22, 2013; 79 FR 28819, May 20, 2014; 80 FR 76386, Dec. 9, 2015; [76 FR 49649, Aug. 11, 2011, as amended at 81 81 FR 17607, Mar. 30, 2016] FR 17607, Mar. 30, 2016; 81 FR 94989, Dec. 27, 2016] § 520.447 Clindamycin solution. § 520.446 Clindamycin capsules and (a) Specifications. Each milliliter of tablets. solution contains the equivalent of 25 milligrams (mg) clindamycin as the (a) Specifications. (1) Each capsule hydrochloride salt. contains the equivalent of 25, 75, 150, or (b) Sponsors. See Nos. 051311, 054771, 300 milligrams (mg) clindamycin as the 058829, 061133, and 069043 in § 510.600(c) of hydrochloride salt. this chapter. (2) Each tablet contains the equiva- (c) Special considerations. Federal law lent of 25, 75, or 150 mg clindamycin as restricts this drug to use by or on the the hydrochloride salt. order of a licensed veterinarian. (3) Each capsule contains the equiva- (d) Conditions of use—(1) Dogs—(i) lent of 25, 75, or 150 mg clindamycin as Amount. Wounds, abscesses, and dental the hydrochloride salt. infections: 2.5 to 15 mg per pound (/lb) (b) Sponsors. See sponsors in body weight every 12 hours for a max- § 510.600(c) of this chapter as follows: imum of 28 days. Osteomyelitis: 5.0 to

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15 mg/lb body weight every 12 hours for If no improvement, administer 2.0 mil- a minimum of 28 days. liliters per 100 pounds (3.2 micrograms (ii) Indications for use. For the treat- per kilogram) for 3 days (6 treatments). ment of skin infections (wounds and If no improvement, horse is non- abscesses) due to susceptible strains of responder to clenbuterol and treatment coagulase-positive staphylococci should be discontinued. (Staphylococcus aureus or S. (ii) Indications for use. Indicated for intermedius), deep wounds and abscesses the management of horses affected due to susceptible strains of Bacteroides with airway obstruction, such as oc- fragilis, Prevotella melaninogenicus, curs in chronic obstructive pulmonary Fusobacterium necrophorum, and Clos- disease (COPD). tridium perfringens; dental infections (iii) Limitations. Treat at effective due to susceptible strains of S. aureus, dose for 30 days. At the end of the 30- B. fragilis, P. melaninogenicus, F. day treatment period, drug should be necrophorum, and C. perfringens; and os- withdrawn. If signs return, the 30-day teomyelitis due to susceptible strains treatment period may be repeated. If of S. aureus, B. fragilis, P. repeating treatment, the step-wise dos- melaninogenicus, F. necrophorum, and C. age schedule should be repeated. The perfringens. effect of this drug on breeding stallions (2) Cats—(i) Amount. 5.0 to 15.0 mg/lb and brood mares has not been deter- body weight every 24 hours for a max- mined. Treatment starting with dos- imum of 14 days. ages higher than the initial dose is not (ii) Indications for use. For the treat- recommended. Federal law prohibits ment of skin infections (wounds and the extralabel use of this drug in food abscesses) due to susceptible strains of animals. Federal law restricts this Staphylococcus aureus, S. intermedius, drug to use by or on the order of a li- Streptococcus spp.; deep wounds and ab- censed veterinarian. scesses due to susceptible strains of (2) [Reserved] Clostridium perfringens and Bacteroides fragilis; and dental infections due to [63 FR 41419, Aug. 4, 1998] susceptible strains of S. aureus, S. intermedius, Streptococcus spp., C. § 520.455 Clomipramine tablets. perfringens, and B. fragilis. (a) Specifications. Each tablet contains 5, 20, 40, or 80 milligrams (mg) [67 FR 54954, Aug. 27, 2002, as amended at 67 FR 78684, Dec. 26, 2002; 68 FR 55824, Sept. 29, clomipramine hydrochloride. 2003; 69 FR 31734, June 7, 2004; 71 FR 39543, (b) Sponsor. See Nos. 058198 and 086039 July 13, 2006; 72 FR 19796, Apr. 20, 2007; 78 FR in § 510.600(c) of this chapter. 17596, Mar. 22, 2013; 78 FR 30197, May 22, 2013; (c) Conditions of use—(1) Amount. 2 to 79 FR 28819, May 20, 2014; 81 FR 17607, Mar. 30, 4 milligrams of clomipramine hydro- 2016; 84 FR 8972, Mar. 13, 2019] chloride per kilogram (0.9 to 1.8 milligrams per pound) of body weight per § 520.452 Clenbuterol syrup. 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; 85 FR 18119, Apr. 1, 2020] liter per 100 pounds (1.6 micrograms per kilogram) for 3 days (6 treatments). If § 520.462 Clorsulon drench. 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).

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(b) Sponsor. See No. 000010 in (iii) Limitations. Federal law restricts § 510.600(c) of this chapter. this drug to use by or on the order of a (c) Related tolerances. See § 556.163 of licensed veterinarian. this chapter. (2) Cats. Use the solution described in (d) Conditions of use. Cattle—(1) paragraph (a)(2) of this section as fol- Amount. One-quarter fluid ounce per 200 low: pounds of body weight (7 milligrams (i) Amount. Administer 7 mg/kg of per kilogram or 3.2 milligrams per body weight orally as a single daily pound of body weight). dose for a minimum of 4 to 6 weeks or (2) Indications for use. For the treat- until resolution of clinical signs. Fol- ment of immature and adult liver fluke lowing this initial daily treatment pe- (Fasciola hepatica) infestations in cat- riod, the dosage may be tapered by de- tle. creasing the frequency of administra- (3) Limitations. Using dose syringe, tion to every other day or twice weekly deposit drench over back of tongue. Do to maintain the desired therapeutic ef- not treat cattle within 8 days of fect. slaughter. Because a withdrawal time (ii) Indications for use. For the control in milk has not been established, do of feline allergic dermatitis in cats at not use in female dairy cattle of breed- least 6 months of age and weighing at ing age. Consult your veterinarian for least 3 pounds. assistance in the diagnosis, treatment, (iii) Limitations. Federal law restricts and control of parasitism. this drug to use by or on the order of a [50 FR 10221, Mar. 14, 1985, as amended at 62 licensed veterinarian. FR 63270, Nov. 28, 1997; 84 FR 32992, July 11, [68 FR 54804, Sept. 19, 2003, as amended at 76 2019; 84 FR 39183, Aug. 9, 2019] FR 78815, Dec. 20, 2011; 84 FR 12493, Apr. 2, 2019] § 520.522 Cyclosporine. (a) Specifications. (1) Each § 520.530 Cythioate oral liquid. cyclosporine capsule, USP (MODIFIED) (a) Specifications. Each milliliter con- contains 10, 25, 50, or 100 milligrams tains 15 milligrams of cythioate. (mg) cyclosporine. (b) Sponsor. See Nos. 000859 and 054771 (2) Each milliliter of cyclosporine in § 510.600 of this chapter. oral solution, USP (MODIFIED) con- (c) Special considerations. Cythioate is tains 100 mg cyclosporine. a cholinesterase inhibitor. Do not use (b) Sponsors. See sponsors in this product in animals simultaneously § 510.600(c) of this chapter. with or within a few days before or (1) No. 058198 for use of products de- after treatment with or exposure to scribed in paragraph (a) as in para- cholinesterase-inhibiting drugs, insec- graph (d) of this section. ticides, pesticides, or chemicals. (2) No. 026637 for use of product de- (d) Conditions of use—(1) Amount. 15 scribed in paragraph (a)(1) as in para- milligrams cythioate per 10 pounds of graph (d)(1) of this section. body weight every third day or twice a (c) [Reserved] week. (d) Conditions of use—(1) Dogs. Use (2) Indications for use. Dogs, for con- capsules described in paragraph (a)(1) trol of fleas. of this section as follow: (i) Amount. Administer 5 mg per kilo- (3) Limitations. Federal law restricts gram (mg/kg) of body weight given this drug to use by or on the order of a orally as a single daily dose for 30 days. licensed veterinarian. Following this initial daily treatment [49 FR 5614, Feb. 14, 1984, as amended at 67 period, the dosage may be tapered by FR 78355, Dec. 24, 2002; 79 FR 28819, May 20, decreasing the frequency of adminis- 2014] tration to every other day or two times a week, until a minimum frequency is § 520.531 Cythioate tablets. reached which will maintain the de- (a) Specifications. Each tablet con- sired therapeutic effect. tains 30 or 90 milligrams (mg) (ii) Indications for use. For the control cythioate. of atopic dermatitis in dogs weighing (b) Sponsors. See sponsor numbers in at least 4 pounds. § 510.600(c) of this chapter as follows:

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(1) No. 000859 for use of 30- and 90-mg (iii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for tablets; up to 7 days, for use as in paragraph (2) No. 054771 for use of the 30-mg tab- (d)(2)(iii) of this section. let. (2) Indications for use. (i) For the con- (c) Conditions of use—(1) Amount. 30 trol of pain and inflammation associ- milligrams cythioate per 20 pounds of ated with osteoarthritis. body weight every third day or twice a (ii) For the control of postoperative week. pain and inflammation associated with (2) Indications for use. Dogs, for con- dental surgery. trol of fleas. (iii) For the control of postoperative (3) Limitations. Federal law restricts pain and inflammation associated with this drug to use by or on the order of a orthopedic surgery. licensed veterinarian. (3) Limitations. Federal law restricts [49 FR 5615, Feb. 14, 1984, as amended at 59 this drug to use by or on the order of a FR 26942, May 25, 1994; 67 FR 78355, Dec. 24, licensed veterinarian. 2002; 79 FR 28819, May 20, 2014] [67 FR 68760, Nov. 13, 2002, as amended at 68 FR 18882, Apr. 17, 2003; 72 FR 37437, July 10, § 520.534 Decoquinate. 2007; 73 FR 33692, June 13, 2008; 77 FR 3928, (a) Specifications. Each gram of pow- Jan. 26, 2012; 84 FR 39183, Aug. 9, 2019] der contains 8 milligrams (0.8 percent) decoquinate. § 520.540 Dexamethasone oral dosage (b) Sponsor. See No. 054771 in forms. § 510.600(c) of this chapter. § 520.540a Dexamethasone powder. (c) Related tolerances. See § 556.170 of this chapter. (a) Specifications. Each packet con- (d) Conditions of use. Calves—(1) tains 10 milligrams (mg) of dexametha- Amount. Feed 22.7 milligrams per 100 sone. pounds of body weight (0.5 milligram (b) Sponsor. See No. 000061 in per kilogram) per day. § 510.600(c) of this chapter. (2) Indications for use. For the preven- (c) Conditions of use in cattle and tion of coccidiosis in ruminating and horses—(1) Amount. Administer 5 to 10 nonruminating calves, including veal mg per animal the first day then 5 mg calves, caused by Eimeria bovis and E. per day as required by drench or by zuernii. sprinkling on a small amount of feed. (3) Limitations. Feed in whole milk at (2) Indications for use. As supportive the rate of 22.7 milligrams per 100 therapy following parenteral steroid pounds body weight daily (0.5 milli- administration for management or in- gram per kilogram) for at least 28 days. flammatory conditions such as acute arthritic lameness, and for various [64 FR 10103, Mar. 2, 1999, as amended at 64 stress conditions where corticosteroids FR 30386, June 8, 1999; 79 FR 28819, May 20, 2014] are required while the animal is being treated for a specific condition. § 520.538 Deracoxib. (3) Limitations. Federal law restricts this drug to use by or on the order of a (a) Specifications. Each tablet con- licensed veterinarian. A withdrawal pe- tains 12, 25, 50, 75, or 100 milligrams riod has not been established for this (mg) deracoxib. product in preruminating calves. Do (b) Sponsor. See Nos. 013744 and 058198 not use in calves to be processed for in § 510.600(c) of this chapter. (c) [Reserved] veal. Do not use in horses intended for (d) Conditions of use in dogs—(1) human consumption. Amount. Administer orally as needed, [79 FR 28819, May 20, 2014] as a single daily dose based on body weight: § 520.540b Dexamethasone tablets and (i) 1 to 2 mg/kilogram (kg) (0.45 to boluses. 0.91 mg/pound (lb)), for use as in para- (a)(1) Specifications. Each bolus is graph (d)(2)(i) of this section. half-scored and contains 10 milligrams (ii) 1 to 2 mg/kg (0.45 to 0.91 mg/lb) for of dexamethasone. 3 days, for use as in paragraph (d)(2)(ii) (2) Sponsor. See No. 000061 in of this section. § 510.600(c) of this chapter.

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(3) Conditions of use in cattle and (2) Indications for use. As supportive horses—(i) Amount. Administer orally 5 therapy in nonspecific dermatosis and to 10 milligrams on the first day, then inflammatory conditions. 5 milligrams per day as required. (3) Limitations. Federal law restricts (ii) Indications for use. As supportive this drug to use by or on the order of a therapy following parenteral steroid licensed veterinarian. administration for management or in- [44 FR 7130, Feb. 6, 1979, as amended at 56 FR flammatory conditions such as acute 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 arthritic lameness, and for various FR 28820, May 20, 2014; 82 FR 11508, Feb. 24, stress conditions where corticosteroids 2017] are required while the animal is being § 520.563 Dexamethasone chewable treated for a specific condition. tablets. (iii) Limitations. Federal law restricts (a) Specifications. Diatrizoate this drug to use by or on the order of a meglumine oral solution is a water licensed veterinarian. A withdrawal pe- soluble radiopaque medium containing riod has not been established for this 66 percent diatrizoate meglumine and product in preruminating calves. Do 10 percent diatrizoate sodium. not use in calves to be processed for (b) Sponsor. See No. 054771 in veal. Do not use in horses intended for § 510.600(c) of this chapter. human consumption. (c) Conditions of use in dogs and cats— (b)(1) Specifications. Each tablet con- (1) Amount. Administer orally 0.5 to 1.0 tains 0.25 milligram of dexamethasone. milliliter per pound of body weight by (2) Sponsors. See Nos. 000061 and 061133 gavage or stomach tube. Administered in § 510.600(c) of this chapter. rectally 0.5 to 1.0 milliliter per pound (3) Conditions of use in dogs and cats— of body weight diluted with 1 part of (i) Amount. Dogs: Administer orally 0.25 the drug to 5 parts of water. to 1.25 milligrams per day for up to 7 (2) Indications for use. For radiog- days. Cats: Administer orally 0.125 to raphy of the gastrointestinal tract. 0.5 milligrams per day for up to 7 days. (3) Limitations. Federal law restricts (ii) Indications for use. As an anti-in- this drug to use by or on the order of a flammatory agent. licensed veterinarian. (iii) Limitations. Federal law restricts [44 FR 12993, Mar. 9, 1979, as amended at 50 this drug to use by or on the order of a FR 41489, Oct. 11, 1985; 79 FR 28820, May 20, licensed veterinarian. 2014] [40 FR 26273, June 23, 1975, as amended at 44 § 520.580 Dichlorophene and toluene. FR 7130, Feb. 6, 1979; 50 FR 49372, Dec. 2, 1985; (a) Specifications. Each capsule con- 52 FR 7832, Mar. 13, 1987; 55 FR 8461, Mar. 8, tains 50 milligrams (mg) of 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 70 FR 16934, Apr. 4, 2005; 79 FR 28819, dichlorophene and 60 mg of toluene, or May 20, 2014; 84 FR 8972, Mar. 13, 2019] multiples thereof. (b) Sponsors. See sponsors in § 520.540c Dexamethasone chewable § 510.600(c) of this chapter for use as in tablets. paragraph (c) of this section: (1) Nos. 017135, 023851, and 058670 for (a) Specifications. Each half-scored use only as a single dose. tablet contains 0.25 milligram of dexa- (2) Nos. 000061, 054771, and 069043 for methasone. use in a single dose or divided-dosage (b) Sponsor. See No. 051031 in regimen. § 510.600(c) of this chapter. (c) Required statement. Consult your (c) Conditions of use in dogs—(1) veterinarian for assistance in the diag- Amount. Administer by free-choice nosis, treatment, and control of para- feeding or crumbled over food 0.25 to sitism, and before administering to 1.25 milligrams daily in single or two weak or debilitated animals. divided doses until response is noted or (d) Conditions of use—(1) Amount. Ad- 7 days have elapsed. When response is minister as follows: attained, dosage should be gradually (i) Single dose: Administer 100 mg of reduced by 0.125 milligram per day dicholorophene and 120 mg of toluene until maintenance level is achieved. per pound of body weight.

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(ii) Divided dose: Administer 100 mg (d) Conditions of use. Dogs—(1) of dichlorophene and 120 mg of toluene Amount. Single dose of 1 tablet (1 gram per 5 pounds of body weight (20 and 24 of dichlorophene) for each 10 pounds of mg per pound) daily for 6 days. body weight. (2) Indications for use. For the re- (2) Indications for use. It is used as an moval of ascarids (Toxocara canis and aid in the removal of tapeworms Toxascaris leonina) and hookworms (Taenia pisiformis and Dipylidium (Ancylostoma caninum and Uncinaria caninum). stenocephala); and as an aid in remov- (3) Limitations. Withhold solid foods ing tapeworms (Taenia pisiformis, and milk for at least 12 hours prior to Dipylidium caninum, and Echinococcus medication and for 4 hours afterward. granulosus) from dogs and cats. (3) Limitations. Withhold solid foods [45 FR 10333, Feb. 15, 1980] and milk for at least 12 hours prior to medication and for 4 hours afterward. § 520.596 Dichlorvos powder. Repeat treatment in 2 to 4 weeks in (a) Specifications—(1) Each 2-ounce animals subject to reinfection. packet contains 2.27 grams (4 percent) [45 FR 10332, Feb. 15, 1980] dichlorvos. (2) Each milligram of powder con- EDITORIAL NOTE: For FEDERAL REGISTER ci- tains 2.27 milligrams (mg) dichlorvos. tations affecting § 520.580, see the List of CFR Sections Affected, which appears in the (b) Sponsor. See No. 069043 in Finding Aids section of the printed volume § 510.600(c) of this chapter for use of the and at www.govinfo.gov. product described in paragraph (a)(1) of this section as in paragraph (d)(1) of § 520.581 Dichlorophene tablets. this section and the product described (a) Specifications. Each tablet con- in paragraph (a)(2) of this section as in tains 1 gram of dichlorophene. paragraph (d)(2) of this section. (b) Sponsor. See 023851 in § 510.600(c) of (c) Related tolerances. See § 556.180 of this chapter. this chapter. (c) Required statement. Consult your (d) Conditions of use—(1) Swine (adult veterinarian for assistance in the diag- gilts, sows, and boars)—(i) Amount. Add nosis, treatment, and control of para- powder to the indicated amount of feed sitism, and before administering to and administered shortly after mixing, weak or debilitated animals. as follows:

Pounds of feed to Pounds of mixed Number of pigs be mixed with feed to be to be treated Weight of animal in pounds each 0.08 administered to per 0.08 ounce of each pig as a ounce of dichlorvos single treatment dichlorvos

20–30 ...... 4 0.33 12 31–40 ...... 5 0.56 9 41–60 ...... 6 1.00 6 61–80 ...... 5 1.00 5 81–100 ...... 4 1.00 4 16 4.00 4

(ii) Indications for use. For the re- or within a few days before or after moval and control of sexually mature treatment with or exposure to cholin- (adult), sexually immature and/or 4th esterase inhibiting drugs, pesticides, or stage larvae of the whipworm (Trichuris chemicals. The preparation should be suis), nodular worms (Oesophagostomum mixed thoroughly with the feed on a spp.), large round-worm (Ascaris suum), clean, impervious surface. Do not allow and the mature thick stomach worm swine access to feed other than that (Ascarops strongylina) occurring in the containing the preparation until treat- lumen of the gastrointestinal tract of ment is complete. Do not treat pigs pigs, boars, and open or bred gilts and with signs of scours until these signs sows. subside or are alleviated by proper (iii) Limitations. Do not use this prod- medication. Resume normal feeding uct on animals either simultaneously

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schedule afterwards. Swine may be re- § 520.598 Dichlorvos tablets. treated in 4 to 5 weeks. (a) Specifications. Each tablet con- (2) Horses—(i) Amount. Administer in tains 2, 5, 10, or 20 milligrams (mg) the grain portion of the ration at a dos- dichlorvos. age of 14.2 to 18.5 mg per pound of body (b) Sponsor. See No. 069043 in weight as a single dose. Administered § 510.600(c) of this chapter. at one-half of the single recommended (c) Conditions of use in dogs, puppies, dosage and repeated 8 to 12 hours later cats, and kittens—(1) Amount. Admin- in the treatment of very aged, emaci- ister orally at 5 mg dichlorvos per ated, or debilitated subjects or those pound of body weight. reluctant to consume medicated feed. (2) Indications for use—(i) Dogs and In suspected cases of severe ascarid in- puppies: Removal and control of intes- fection sufficient to cause concern over tinal roundworms (Toxocara canis and mechanical blockage of the intestinal Toxascaris leonina) and hookworms tract, the split dosage should be used. (Ancylostoma caninum and Uncinaria (ii) Indications for use. For the re- stenocephala). moval and control of bots (Gastrophilus (ii) Cats and kittens: Removal and intestinalis, G. nasalis), large strongyles control of intestinal roundworms (Strongylus vulgaris, S. equinus, S. (Toxocara cati and Toxascaris leonina) edentatus), small strongyles (of the gen- and hookworms (Ancylostoma era Cyathostomum, Cylicocercus, tubaeforme and Uncinaria stenocephala). Cylicocyclus, Cylicodontophorus, (3) Limitations. Federal law restricts Triodontophorus, Poteriostomum, this drug to use by or on the order of a licensed veterinarian. Gyalocephalus), pinworms (Oxyuris equi), and large roundworm (Parascaris [83 FR 48945, Sept. 28, 2018] equorum) in horses including ponies and mules. Not for use in foals (sucklings § 520.600 Dichlorvos capsules and pel- and young weanlings). lets. (iii) Limitations. Do not use in horses (a) Specifications. Each capsule con- which are severely debilitated, suf- tains 2.27 milligrams (mg) (4 percent) fering from diarrhea or severe con- dichlorvos. stipation, infectious disease, toxemia, (b) Sponsor. See No. 069043 in or colic. Do not administer in conjunc- § 510.600(c) of this chapter. tion with or within 1 week of adminis- (c) Conditions of use in dogs—(1) tration of muscle relaxant drugs, Amount. Administer any combination phenothiazine derived tranquilizers or of capsules and/or pellets so that the animal receives a single dose equaling central nervous system depressant 12 to 15 mg of dichlorvos per pound of drugs. Horses should not be subjected body weight. to insecticide treatment for 5 days (2) Indications for use. For removal of prior to or after treating with the drug. Toxocara canis and Toxascaris leonina Do not administer to horses afflicted (roundworms), Ancylostoma caninum with chronic alveolar emphysema and Uncinaria stenocephala (heaves) or related respiratory condi- (hookworms), and Trichuris vulpis tions. The product is a cholinesterase (whipworm) residing in the lumen of inhibitor and should not be used simul- the gastrointestinal tract. taneously or within a few days before (3) Limitations. Federal law restricts or after treatment with or exposure to this drug to use by or on the order of a cholinesterase inhibiting drugs, pes- licensed veterinarian. ticides or chemicals. Do not use in ani- [83 FR 48945, Sept. 28, 2018] mals other than horses, ponies, and mules. Do not use in horses, ponies, § 520.602 Dichlorvos gel. and mules intended for food purposes. Do not allow fowl access to feed con- (a) Specifications. Each milligram (mg) of gel contains 2.27 milligrams taining this preparation or to fecal ex- (mg) dichlorvos. crement from treated animals. (b) Sponsor. See No. 069043 in [83 FR 48944, Sept. 28, 2018] § 510.600(c) of this chapter.

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(c) Conditions of use in horses—(1) titis) due to penicillinase-producing Amount. Administer 20 mg per kilo- staphylococci sensitive to gram of body weight for the removal of dicloxacillin. bots and ascarids. Repeat administra- (3) Limitations. Federal law restricts tion every 21 to 28 days for the control this drug to use by or on the order of a of bots and ascarids. For the control of licensed veterinarian. bots only, the repeat dosage is 10 milli- [57 FR 37325, Aug. 18, 1992, as amended at 79 grams per kilogram of body weight FR 28820, May 20, 2014] every 21 to 28 days during bot fly season. § 520.620 Diethylcarbamazine oral dos- (2) Indications for use. For the re- age forms. moval and control of first, second, and third instar bots (Gastrophilus § 520.622 Diethylcarbamazine citrate intestinalis and G. nasalis), sexually ma- oral dosage forms. ture and sexually immature (4th stage) § 520.622a Diethylcarbamazine citrate ascarids (Parascaris equorum) in horses tablets. and foals. (a) Sponsors. (1) [Reserved] (3) Do not use in horses Limitations. (2) See 054771 in § 510.600(c) of this intended for human consumption. Fed- chapter for use of 100, 200, and 300 milli- eral law restricts this drug to use by or gram tablets for prevention of heart- on the order of a licensed veterinarian. worm disease in dogs and as an aid in [83 FR 48945, Sept. 28, 2018] the treatment of ascarid infections in dogs. § 520.606 Diclazuril. (3) See 061133 in § 510.600(c) of this (a) Specifications. Each 100 grams (g) chapter for use of 50, 100, 200, 300, or 400 of pellets contain 1.56 g diclazuril. milligram tablets for prevention of (b) Sponsor. See No. 000061 in heartworm disease in dogs, as an aid in § 510.600(c) of this chapter. the control of ascarid infections in (c) Conditions of use in horses—(1) dogs, and as an aid in the treatment of Amount. Administer 1 milligram (mg) ascarid infections in dogs and cats. per kilogram (0.45 mg per pound) of (4) [Reserved] body weight in the daily grain ration (5) See No. 000061 in § 510.600(c) of this for 28 days. chapter for use of 60, 120, or 180 milli- (2) Indications for use. For the treat- gram tablets for prevention of heart- ment of equine protozoal worm disease in dogs, as an aid in the myeloencephalitis (EPM) caused by control of ascarid infections in dogs, Sarcocystis neurona. and as an aid in the treatment of asca- (3) Limitations. Do not use in horses rid infections in dogs and cats. intended for human consumption. Fed- (6) See No. 069043 in § 510.600(c) of this eral law restricts this drug to use by or chapter for use of 50, 100, 200, 300, or 400 on the order of a licensed veterinarian. milligram tablets for prevention of heartworm disease in dogs, as an aid in [72 FR 20943, Apr. 27, 2007] the control of ascarid infections in dogs, and as an aid in the treatment of § 520.608 Dicloxacillin. ascarid infections in dogs and cats. (a) Specifications. Each capsule con- (b) Conditions of use—(1) Dosage/indi- tains dicloxacillin sodium cations for use. (i) Three milligrams per monohydrate equivalent to 50, 100, 200, pound of body weight daily for preven- or 500 milligrams of dicloxacillin. tion of heartworm disease (Dirofilaria (b) Sponsor. See No. 054771 in § 510.600 immitis) in dogs. (c) of this chapter. (ii) Three milligrams per pound of (c) Conditions of use in dogs—(1) body weight daily as an aid in the con- Amount. Administer orally 5 to 10 milli- trol of ascarid infections (Toxocara grams per pound of body weight, three canis) in dogs. times daily. In severe cases, up to 25 (iii) Twenty-five to 50 milligrams per milligrams per pound of body weight pound of body weight as an aid in the three times daily. treatment of ascarid infections in dogs (2) Indications for use. For the treat- (Toxocara canis) and cats (Toxocara ment of pyoderma (pyogenic derma- canis and Toxascaris leonina).

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(2) Limitations. Federal law restricts (3) Conditions of use. (i) The drug is this drug to use by or on the order of a used in dogs between 4 weeks and 8 licensed veterinarian. months of age for the removal of ascarids (Toxacara canis) and in ani- [46 FR 23230, Apr. 24, 1981, as amended at 46 mals over 4 weeks of age for the pre- FR 41038, Aug. 14, 1981; 46 FR 46315, Sept. 18, 1981; 46 FR 61653, Dec. 18, 1981; 47 FR 10805, vention of heartworm disease Mar. 12, 1982; 47 FR 14150, Apr. 2, 1982; 50 FR (Dirofilaria immitis). 41489, Oct. 11, 1985; 50 FR 49372, Dec. 2, 1985; (ii) The drug is administered (a) for 53 FR 40056, Oct. 13, 1988; 53 FR 40727, Oct. 18, removal of ascarids at a dosage of 50 1988; 55 FR 8461, Mar. 8, 1990; 61 FR 34728, milligrams per pound of body weight July 3, 1996; 62 FR 35076, June 30, 1997; 66 FR divided into two equal doses and ad- 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 76 ministered 8 to 12 hours apart (morning FR 17777, Mar. 31, 2011; 77 FR 4896, Feb. 1, and night), orally or mixed with either 2012; 78 FR 21059, Apr. 7, 2013; 79 FR 28820, dry or wet food, and (b) for prevention May 20, 2014; 83 FR 48945, Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019] 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 mosquito activity, during the mosquito (a)(1) Specifications. Each milliliter of season, and for 2 months following the syrup contains 60 milligrams of end thereof. diethylcarbamazine citrate. (iii) Dogs older than 8 months of age (2) Sponsor. See No. 054771 in may be infected with Dirofilaria immitis. § 510.600(c) of this chapter. Use of the drug is contraindicated in (3) Conditions of use. (i) The drug is dogs with active D. immitis infections. indicated for use in dogs for the pre- (iv) Federal law restricts this drug to vention of infection with Dirofilaria use by or on the order of a licensed vet- immitis and T. canis and T. leonina. It is erinarian. also indicated for treatment of ascarid infections of T. canis and T. leonina in [40 FR 13838, Mar. 27, 1975, as amended at 41 FR 28265, July 9, 1976; 44 FR 3967, Jan. 19, dogs and T. cati in cats. 1979; 47 FR 14150, Apr. 2, 1982; 47 FR 35186, (ii) For prevention of heartworm and Aug. 13, 1982; 49 FR 33997, Aug. 28, 1984; 50 FR ascarid infections in dogs, the drug 41489, Oct. 11, 1985; 53 FR 47027, Oct. 18, 1988; may be added to the daily diet at a dos- 61 FR 34728, July 3, 1996; 62 FR 35076, June 30, age rate of 3.0 milligrams per pound of 1997; 62 FR 38906, July 21, 1997; 77 FR 4897, body weight per day or given directly Feb. 1, 2012; 78 FR 21059, Apr. 9, 2013; 79 FR by mouth at the same dosage rate. For 28820, May 20, 2014; 83 FR 48945, Sept. 28, 2018] treatment of ascarid infections in dogs § 520.622c Diethylcarbamazine citrate and cats, the drug is administered at a chewable tablets. dosage level of 25 to 50 milligrams per (a) Specifications. Each chewable tab- pound of body weight preferably ad- let contains 30, 45, 60, 120, 150, or 180 ministered immediately after feeding. milligrams of diethylcarbamazine cit- (iii) Older dogs should be proven neg- rate. ative for the presence of Dirofilaria (b) Sponsors. See drug listing nos. in immitis infection before administration § 510.600(c) of this chapter for identi- of the drug. Those with proven infec- fication of sponsors as follows: tion of Dirofilaria immitis should be ren- (1) [Reserved] dered negative using adulticidal and (2) For 054771, use of 60, 120, or 180 microfilaricidal drugs before adminis- milligram tablets as in paragraph tration of this drug. (c)(2)(ii) of this section. (iv) Federal law restricts this drug to (3) For 061690, use of 45 or 150 milli- use by or on the order of a licensed vet- gram tablets as in paragraph (c)(2)(iii) erinarian. of this section. (b) [Reserved] (4) For 061133, use of 60-, 120-, or 180- (c)(1) Specifications. Each milliliter of milligram tablets as in paragraph syrup contains 60 milligrams of (c)(2)(i) of this section. diethylcarbamazine citrate. (5) For 000061, use of 60-milligram (2) Sponsor. See No. 069043 in tablets as in paragraph (c)(2)(i) of this § 510.600(c) of this chapter. section.

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(6) For 069043, use of 30, 60, 120, or 180 immature stages of intestinal Toxocara milligram tablets as in paragraph canis (ascarid infection). (c)(2)(i) of this section. (3) Limitations. Federal law restricts (c) Conditions of use—(1) Amount. 3 this drug to use by or on the order of a milligrams per pound of body weight licensed veterinarian. per day for prevention of heartworm disease and control of ascarids; 25 to 50 [50 FR 28768, July 16, 1985, as amended at 53 milligrams per pound of body weight as FR 45759, Nov. 14, 1988; 54 FR 3776, Jan. 26, 1989; 54 FR 6804, Feb. 14, 1989; 56 FR 50653, an aid in treatment of ascarid infec- Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR tions. 28820, May 20, 2014] (2) Indications for use. (i) For prevention of heartworm disease (Dirofilaria § 520.645 Difloxacin. immitis) in dogs; as an aid in control of ascarids (Toxocara canis) in dogs; as an (a) Specifications. Each tablet con- aid in treatment of ascarid (Toxocara tains 11.4, 45.4, or 136 milligrams (mg) canis and Toxascaris leonina) infections of difloxacin hydrochloride. in dogs and cats. (b) Sponsor. See No. 000010 in (ii) For prevention of infection with § 510.600(c) of this chapter. Dirofilaria immitis (heartworm disease) (c) [Reserved] in dogs; as an aid in treatment of asca- (d) Conditions of use—(i) Amount. Ad- rid (Toxocara canis and Toxascaris minister 5 to 10 mg per kilogram (2.3 to leonina) infections in dogs. 4.6 mg per pound) of body weight orally (iii) For prevention of heartworm dis- once a day for 2 to 3 days beyond ces- ease (Dirofilaria immitis) in dogs. sation of clinical signs of disease up to (3) Limitations. Federal law restricts a maximum of 30 days. this drug to use by or on the order of a (ii) Indications for use. For manage- licensed veterinarian. ment of diseases in dogs associated [43 FR 6941, Feb. 17, 1978] with bacteria susceptible to difloxacin. (iii) Limitations. Federal law prohibits EDITORIAL NOTE: For FEDERAL REGISTER ci- the extra-label use of this drug in food- tations affecting § 520.622c, see the List of producing animals. Federal law re- CFR Sections Affected, which appears in the Finding Aids section of the printed volume stricts this drug to use by or on the and at www.govinfo.gov. order of a licensed veterinarian. (2) [Reserved] § 520.623 Diethylcarbamazine and oxibendazole chewable tablets. [63 FR 8123, Feb. 18, 1998, as amended at 75 FR 10165, Mar. 5, 2010] (a) Specifications. Each tablet contains either 60, 120, or 180 milligrams of § 520.666 Dirlotapide. diethylcarbamazine citrate with 45, 91, or 136 milligrams of oxibendazole, re- (a) Specifications. Each milliliter spectively. (mL) of solution contains 5 milligrams (mg) dirlotapide. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (b) Sponsor. See No. 054771 in (c) Conditions of use in dogs—(1) § 510.600(c) of this chapter. Amount. Administer orally to dogs at a (c) Conditions of use in dogs—(1) dosage level of 6.6 milligrams of Amount. The initial dosage is 0.01 mL/ diethylcarbamazine citrate per kilo- kg (0.0045 mL/lb) body weight for the gram of body weight (3 milligrams per first 14 days. After the first 14 days of pound of body weight) and 5.0 milli- treatment, the dose volume is doubled grams of oxibendazole per kilogram of to 0.02 mL/kg (0.009 mL/lb) body weight body weight (2.27 milligrams per pound for the next 14 days (days 15 to 28 of of body weight). treatment). Dogs should be weighed (2) Indications for use. For prevention monthly and the dose volume adjusted of infection with Dirofilaria immitis every month, as necessary, to maintain (heartworm disease) and Ancylostoma a target percent weight loss until the caninum (hookworm infection) and for desired weight is achieved. removal and control of Trichuris vulpis (2) Indications for use. For the man- (whipworm infection) and mature and agement of obesity.

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(3) Limitations. Federal law restricts (iii) For Strongyloides (Strongyloides this drug to use by or on the order of a canis, Strongyloides stercoralis): 10 mg/lb licensed veterinarian. of body weight for 10 to 12 days; [72 FR 263, Jan. 4, 2007, as amended at 79 FR (iv) For heartworm microfilariae 28820, May 20, 2014] (Dirofilaria immitus): 3 to 5 mg/lb of body weight for 7 to 10 days. Treatment § 520.763 Dithiazanine oral dosage for heartworm microfilariae should fol- forms. low 6 weeks after therapy for adult worms. § 520.763a Dithiazanine tablets. (2) Limitations. Federal law restricts (a) Specifications. Each tablet con- this drug to use by or on the order of a tains 10, 50, 100, or 200 milligrams (mg) licensed veterinarian. dithiazanine iodide. (b) Sponsor. See No. 069043 in [79 FR 28820, May 20, 2014, as amended at 83 § 510.600(c) of this chapter. FR 48945, Sept. 28, 2018] (c) Conditions of use in dogs—(1) Indi- § 520.763c Dithiazanine iodide and pi- cations for use and amount. Administer perazine citrate suspension. orally immediately after feeding as follows: (a) Specifications. Each milliliter of (i) For large roundworms (Toxocara suspension contains 69 milligrams (mg) canis, Toxascaris leonina): 10 mg per dithiazanine iodide and 83 mg piper- pound (/lb) of body weight for 3 to 5 azine base (as piperazine citrate). days; (b) Sponsor. See No. 069043 in (ii) For hookworms (Ancylostoma § 510.600(c) of this chapter. caninum, Uncinaria stenocephala) and (c) Conditions of use in horses—(1) whipworms (Trichuris vulpis): 10 mg/lb Amount. 1 ounce (30 milliliters) per 100 of body weight for 7 days; pounds of body weight for the first 500 (iii) For Strongyloides (Strongyloides pounds; 3⁄4 ounce for each 100 pounds canis, Strongyloides stercoralis): 10 mg/lb thereafter, up to 1,200 pounds; 101⁄4 of body weight for 10 to 12 days; ounces to animals over 1,200 pounds. (iv) For heartworm microfilariae (2) Indications for use. For control of (Dirofilaria immitus): 3 to 5 mg/lb of large roundworms, Parascaris equorum; body weight for 7 to 10 days. Treatment small strongyles; large strongyles, for heartworm microfilariae should fol- Strongylus vulgaris; and pinworms, low 6 weeks after therapy for adult Oxyuris equi. worms. (3) Limitations. Administer by drench (2) Limitations. Federal law restricts or mixed with the daily ration as a sin- this drug to use by or on the order of a gle dose. Treatment is recommended in licensed veterinarian. spring and fall. In a heavily infested [79 FR 28820, May 20, 2014, as amended at 83 environment, treatment may be re- FR 48945, Sept. 28, 2018] peated every 30 days. Not for use in horses intended for food purposes. Se- § 520.763b Dithiazanine powder. verely debilitated animals should not (a) Specifications. Each tablespoon of be wormed except on the advice of a powder contains 200 milligrams (mg) veterinarian. If the drug is for adminis- dithiazanine iodide. tration by stomach tube, it shall be la- (b) Sponsor. See No. 069043 in beled: ‘‘Federal law restricts this drug § 510.600(c) of this chapter. to use by or on the order of a licensed (c) Conditions of use in dogs—(1) Indi- veterinarian.’’ cations for use and amount. Administer [47 FR 52696, Nov. 23, 1982, as amended at 48 orally by mixing in food as follows: FR 32342, July 15, 1983; 53 FR 40727, Oct. 18, (i) For large roundworms (Toxocara 1988; 62 FR 35076, June 30, 1997; 78 FR 21059, canis, Toxascaris leonina): 10 mg per Apr. 9, 2013; 79 FR 28820, May 20, 2014; 83 FR pound (/lb) of body weight for 3 to 5 48945, Sept. 28, 2018] days; (ii) For hookworms (Ancylostoma § 520.766 Domperidone. caninum, Uncinaria stenocephala) and (a) Specifications. Each milliliter of whipworms (Trichuris vulpis): 10 mg/lb gel contains 110 milligrams (mg) of body weight for 7 days; domperidone.

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(b) Sponsor. See No. 043264 in § 510.600 (3) Limitations. Federal law restricts of this chapter. this drug to use by or on the order of a (c) Conditions of use in horses—(1) licensed veterinarian. Amount. Administer 0.5 mg per pound (mg/lb) (1.1 mg/kilogram (kg)) by [79 FR 28821, May 20, 2014, as amended at 80 FR 34278, June 16, 2015; 84 FR 39183, Aug. 9, mouth once daily starting 10 to 15 days 2019] prior to the expected foaling date. Treatment may be continued for up to § 520.812 Enrofloxacin. 5 days after foaling if mares are not (a) Specifications—(1) Each tablet con- producing adequate milk. tains: (2) Indications for use. For prevention of fescue toxicosis in periparturient (i) 22.7, 68.0, or 136.0 milligrams (mg) mares. enrofloxacin; or (3) Limitations. Do not use in horses (ii) 22.7, 68.0, 136.0, or 272 mg intended for human consumption. Fed- enrofloxacin. eral law restricts this drug to use by or (2) Each soft chewable tablet con- on the order of a licensed veterinarian. tains 22.7, 68.0, or 136.0 mg enrofloxacin. (b) Sponsors. See sponsor numbers in [75 FR 67031, Nov. 1, 2010] § 510.600(c) of this chapter for use as in paragraph (c) of this section. § 520.784 Doxylamine. (1) Nos. 000859 and 026637 for use of (a) Specifications. The drug is in tab- product described in paragraph (a)(1)(i) let form and contains doxylamine suc- of this section. cinate as the active drug ingredient. (2) No. 058198 for use of product de- (b) Sponsor. See No. 000061 in scribed in paragraph (a)(1)(ii) of this § 510.600(c) of this chapter. section. (c) Conditions of use—(1) Amount. (3) No. 000859 for use of product de- Horses: Administer orally 1 to 2 milli- scribed in paragraph (a)(2) of this sec- grams (mg) per pound (/lb) of body tion. weight per day divided into 3 or 4 equal (c) Conditions of use in dogs and cats— doses. Dogs and cats: Administer orally (1) Amount. Administer orally as a sin- 2 to 3 mg/lb of body weight per day di- gle, daily dose or divided into two vided into 3 or 4 equal doses. equal doses at 12-hour intervals. (2) Indications for use. For use when (i) Dogs. 5 to 20 mg per kilogram (/kg) antihistaminic therapy may be ex- (2.27 to 9.07 mg per pound (/lb)) of body pected to alleviate some signs of dis- weight. ease in horses, dogs, and cats. (ii) Cats. 5 mg/kg (2.27 mg/lb) of body (3) Limitations. Do not use in horses weight. intended for human consumption. Fed- eral law restricts this drug to use by or (2) Indications for use. For the man- on the order of a licensed veterinarian. agement of diseases associated with bacteria susceptible to enrofloxacin. [40 FR 13838, Mar. 27, 1975, as amended at 42 (3) Limitations. Federal law restricts FR 60140, Nov. 25, 1977; 46 FR 48642, Oct. 2, this drug to use by or on the order of a 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, licensed veterinarian. Federal law pro- Nov. 19, 1997; 79 FR 28821, May 20, 2014] hibits the extralabel use of this drug in § 520.804 Enalapril. food-producing animals. (a) Specifications. Each tablet con- [78 FR 30197, May 22, 2013, as amended at 78 tains 1.0, 2.5, 5.0, 10, or 20 milligrams FR 52853, Aug. 27, 2013; 84 FR 8972, Mar. 13, (mg) of enalapril maleate. 2019; 84 FR 53310, Oct. 7, 2019] (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. § 520.816 Epsiprantel. (c) Conditions of use in dogs—(1) (a) Specifications. Each tablet con- Amount. Administer orally 0.5 to 1.0 mg tains either 12.5, 25, 50, or 100 milli- of enalapril maleate per kilogram of grams of epsiprantel. body weight per day. (b) Sponsor. See No. 054771 in (2) Indications for use. For the treat- § 510.600(c) of this chapter. ment of mild, moderate, and severe (c) Conditions of use—(1) Dogs—(i) (modified New York Heart Association Amount. 2.5 milligrams per pound of Class II, III, IV) heart failure in dogs. body weight.

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(ii) Indications for use. Removal of ca- (ii) Indications for use. As an aid in nine cestodes Dipylidium caninum and the control of blue comb (nonspecific Taenia pisiformis. infectious enteritis) caused by orga- (2) Cats—(i) Amount. 1.25 milligrams nisms susceptible to erythromycin. per pound of body weight. (iii) Limitations. Do not use in tur- (ii) Indications for use. Removal of fe- keys producing eggs for human con- line cestodes D. caninum and T. sumption. Withdraw 1 day before taeniaeformis. slaughter. Federal law restricts this (3) 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. [40 FR 13838, Mar. 27, 1975, as amended at 45 [54 FR 50615, Dec. 8, 1989, as amended at 56 FR 56798, Aug. 26, 1980; 66 FR 14073, Mar. 9, FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 2001; 68 FR 4914, Jan. 31, 2003; 79 FR 28821, 1995; 79 FR 28821, May 20, 2014; 83 FR 64740, May 20, 2014; 81 FR 17607, Mar. 30, 2016; 81 FR Dec. 18, 2018] 94989, Dec. 27, 2016; 84 FR 8972, Mar. 13, 2019]

§ 520.823 Erythromycin. § 520.852 Estriol. (a) Specifications. Each gram of pow- (a) Specifications. Each tablet con- der contains erythromycin phosphate tains 1 milligram (mg) estriol. equivalent to 0.89 gram of erythro- (b) Sponsor. See No. 000061 in mycin master standard. § 510.600(c) of this chapter. (b) Sponsor. See No. 061133 in (c) Conditions of use in dogs—(1) § 510.600(c) of this chapter. Amount. Administer at an initial dose (c) Related tolerances. See § 556.230 of of 2 mg per dog per day. The dosage this chapter. may be titrated to as low as 0.5 mg per (d) Conditions of use. It is used in dog every second day, depending on re- drinking water as follows: sponse. (1) Broiler and replacement chickens— (2) Indications for use. For the control (i) Amount. Administer 0.500 gram per of estrogen-responsive urinary inconti- gallon for 5 days. nence in ovariohysterectomized female (ii) Indications for use. As an aid in dogs. the control of chronic respiratory dis- (3) Limitations. Federal law restricts ease due to Mycoplasma gallisepticum this drug to use by or on the order of a susceptible to erythromycin. licensed veterinarian. (iii) Limitations. Do not use in replacement pullets over 16 weeks of age. [76 FR 78150, Dec. 16, 2011] Do not use in chickens producing eggs for human consumption. Withdraw 1 § 520.863 Ethylisobutrazine. day before slaughter. Federal law re- (a) Specifications. Each tablet con- stricts this drug to use by or on the tains either 10 milligrams or 50 milli- order of a licensed veterinarian. grams of ethylisobutrazine hydro- (2) Replacement chickens and chicken chloride. breeders—(i) Amount. Administer 0.500 (b) Sponsor. See No. 000061 in gram per gallon for 7 days. § 510.600(c) of this chapter. (ii) Indications for use. As an aid in (c) Conditions of use in dogs—(1) the control of infectious coryza due to Amount. Administer orally 2 to 5 milli- Haemophilus gallinarum susceptible to erythromycin. grams per pound of body weight once daily. (iii) Limitations. Do not use in replacement pullets over 16 weeks of age. (2) Indications for use. As a tranquil- Do not use in chickens producing eggs izer. for human consumption. Withdraw 1 (3) Limitations. Federal law restricts day before slaughter. Federal law re- this drug to use by or on the order of a stricts this drug to use by or on the licensed veterinarian. order of a licensed veterinarian. [40 FR 13838, Mar. 27, 1975, as amended at 46 (3) Growing turkeys—(i) Amount. Ad- FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; minister 0.500 gram per gallon for 7 62 FR 61624, Nov. 19, 1997; 79 FR 28821, May 20, days. 2014]

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§ 520.870 Etodolac. (b) Sponsor. See No. 000859 in § 510.600(c) of this chapter. (a) Specifications. Each tablet con- (c) Conditions of use in horses—(1) tains 150, 300, or 500 milligrams (mg) of Amount. 3 milliliters per 100 pounds etodolac. body weight or 1 fluid ounce per 1000 (b) Sponsor. See No. 000010 in pounds (6 milligrams per kilogram § 510.600(c) of this chapter. body weight). Administer by stomach (c) Conditions of use in dogs—(1) tube or drench, or by mixing well into Amount. Administer 10 to 15 mg per a portion of the normal grain ration. kilogram (4.5 to 6.8 mg per pound) of For animals maintained on premises body weight per day orally. where reinfection is likely to occur, re- (2) Indications for use. For the man- treatment may be necessary. For most agement of pain and inflammation as- effective results, retreat in 6 to 8 sociated with osteoarthritis. weeks. (3) Limitations. Federal law restricts (2) Indications for use. For removal of this drug to use by or on the order of a ascarids (Parascaris equorum—adult and licensed veterinarian. sexually immature), pinworms (Oxyuris [63 FR 51300, Sept. 25, 1998, as amended at 68 equi—adult and 4th stage larvae), large FR 51705, Aug. 28, 2003; 75 FR 10166, Mar. 5, strongyles (Strongylus vulgaris, S. 2010; 79 FR 28821, May 20, 2014] edentatus, S. equinus), and various small strongyles in horses, breeding § 520.903 Febantel oral dosage forms. stallions and mares, pregnant mares, foals, and ponies. § 520.903a Febantel paste. (3) Limitations. Do not use in horses (a) Specifications. Each gram of paste intended for human consumption. Fed- contains 455 milligrams (45.5 percent) eral law restricts this drug to use by or febantel. on the order of a licensed veterinarian. (b) Sponsor. See No. 000859 in (d) Special considerations. Febantel § 510.600(c) of this chapter. suspension may be used in combination (c) Conditions of use in horses—(1) with trichlorfon oral liquid in accord- Amount. Administer paste orally at 6 ance with the provisions of § 520.2520c, milligrams per kilogram (2.73 milli- this section, and the following condi- grams per pound) of body weight on the tions: base of the tongue or well mixed into a (1) Combine 1 part febantel suspen- portion of the normal grain ration. For sion with 5 parts trichlorfon liquid. animals maintained on premises where (2) Allow animal to consume a por- reinfection is likely to occur, retreat- tion of daily grain ration; administer ment may be necessary. For most ef- mixture by stomach tube at rate of 18 fective results, retreat in 6 to 8 weeks. milliliters per 100 pounds of body (2) Indications for use. For removal of weight. large strongyles (Strongylus vulgaris, S. [45 FR 8587, Feb. 8, 1980, as amended at 79 FR edentatus, S. equinus); ascarids 28821, May 20, 2014] (Parascaris equorum—sexually mature and immature); pinworms (Oxyuris § 520.903c Febantel and praziquantel equi—adult and 4th stage larva); and paste. various small strongyles in horses, (a) Specifications. Each gram of paste foals, and ponies. contains 34 milligrams of febantel and (3) Limitations. Do not use in horses 3.4 milligrams of praziquantel. intended for human consumption. Con- (b) Sponsor. See No. 000859 in sult your veterinarian for assistance in § 510.600(c) of this chapter. the diagnosis, treatment, and control (c) Conditions of use—(1) Amount—(i) of parasitism. Dogs and cats (over 6 months of age): 10 milligrams of febantel and 1 milligram [79 FR 28821, May 20, 2014] of praziquantel per kilogram of body weight (1 gram of paste per 7.5 pounds § 520.903b Febantel suspension. body weight) administered by mouth or (a) Specifications. Each ounce of sus- in the food once daily for 3 days. pension contains 2.75 grams (9.3 percent (ii) Puppies and kittens (less than 6 ounce) febantel. months of age): 15 milligrams of

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febantel and 1.5 milligrams of § 520.905 Fenbendazole oral dosage praziquantel per kilogram of body forms. weight (1 gram of paste per 5 pounds body weight) administered by mouth § 520.905a Fenbendazole suspension. on a full stomach once daily for 3 days. (a) Specifications. Each milliliter of (2) Indications for use. (i) Dogs and suspension contains 100 milligrams puppies: For removal of hookworms (mg) fenbendazole for use as in para- (Ancylostoma caninum and Uncinaria graphs (e)(1), (2), (3), and (4) of this sec- stenocephala), whipworms (Trichuris tion; or 200 mg fenbendazole for use as vulpis), ascarids (Toxocara canis and in paragraphs (e)(5) and (6) of this sec- Toxascaris leonina), and tapeworms tion. (Dipylidium caninum and Taenia (b) Sponsor. See No. 000061 in pisiformis). § 510.600(c) of this chapter. (ii) Cats and kittens: For removal of (c) Related tolerances. See § 556.275 of hookworms (Ancylostoma tubaeforme), this chapter. ascarids (Toxocara cati) and tapeworms (d) Special considerations. (1) See (Dipylidium caninum and Taenia § 500.25 of this chapter. taeniaeformis). (2) Fenbendazole suspension 10 per- (3) Limitations. Federal law restricts cent and approved forms of trichlorfon, this drug to use by or on the order of a when used concomitantly for treating licensed veterinarian. the indications provided in paragraph (e) of this section and for treating in- [50 FR 19167, May 7, 1985, as amended at 53 fections of stomach bot as provided in FR 48533, Dec. 1, 1988; 56 FR 50813, Oct. 9, 1991; § 520.2520, have been shown to be com- 79 FR 28821, May 20, 2014. Redesignated at 85 patible and not to interfere with one FR 18119, Apr. 1, 2020] another. (e) Conditions of use—(1) Horses—(i) § 520.903d Febantel tablets. Amount. Administer orally 5 mg per (a) Specifications. Each scored tablet kilogram (/kg) (2.3 mg per pound (/lb)) contains 27.2 milligrams of febantel for for the control of large strongyles, use in dogs, puppies, cats, and kittens small strongyles, and pinworms; 10 mg/ or 163.3 milligrams of febantel for use kg for the control of ascarids. in dogs, puppies, and cats. (ii) Indications for use. For the control (b) Sponsor. See No. 000859 in of large strongyles (Strongylus § 510.600(c) of this chapter. edentatus, S. equinus, S. vulgaris), small (c) Conditions of use—(1) Amount—(i) strongyles (Cyanthostomum spp., Dogs and cats. Ten milligrams per kilo- Cylicocyclus spp., Cylicostephanus spp., gram body weight. Administer once Triodontophorus spp.), pinworms daily for 3 consecutive days. (Oxyuris equi), and ascarids (Parascaris (ii) Puppies and kittens fewer than 6 equorum) in horses. months of age. Fifteen milligrams per (iii) Limitations. Administer by dose kilogram body weight. Administer once syringe or suitable plastic syringe. Do daily for 3 consecutive days. not use in horses intended for human consumption. (2) Indications for use. (i) For removal (2) Cattle including dairy cows of breed- of hookworms (Ancylostoma caninum ing age—(i) Amount. Administer orally 5 and Uncinaria stenocephala), ascarids mg/kg of body weight (2.3 mg/lb). Re- (Toxocara canis and Toxascaris leonina) treatment may be needed after 4 to 6 and whipworms (Trichuris vulpis) in weeks. dogs and puppies. (ii) Indications for use. For the re- (ii) For removal of hookworms moval and control of lungworm (Ancylostoma tubaeforme) and ascarids (Dictyocaulus viviparus); stomach worm (Toxocara cati) in cats and kittens. (adults)—brown stomach worm (3) Limitations. Federal law restricts (Ostertagia ostertagi); stomach worms this drug to use by or on the order of a (adults and 4th-stage larvae)— licensed veterinarian. barberpole worm (Haemonchus contortus [56 FR 50655, Oct. 8, 1991, as amended at 79 FR and H. placei) and small stomach worm 28821, May 20, 2014. Redesignated at 85 FR (Trichostongylus axei); intestinal worms 18119, Apr. 1, 2020] (adults and 4th-stage larvae)—

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hookworm (Bunostonmum phlebotomum), (6) Swine, except for nursing piglets—(i) threadnecked intestinal worm Amount. Administer orally via the (Nematodirus helvetianus), small intes- drinking water at a daily dose of 2.2 tinal worm (Cooperia punctata and C. mg/kg of body weight (1.0 mg/lb) for 3 oncophora), bankrupt worm consecutive days. (Trichostrongylus colubriformis), and (ii) Indications for use. For the treat- nodular worm (Oesophagostomum ment and control of lungworms: Adult radiatum). Metastrongylus apri, adult M. (iii) Limitations. Cattle must not be pudendotectus; gastrointestinal worms: slaughtered within 8 days following Adult and larvae (L3, L4 stages, liver, last treatment. A withdrawal period lung, intestinal forms) large has not been established for this prod- roundworms (Ascaris suum); nodular uct in preruminating calves. Do not worms (Oesophagostomum dentatum, O. use in calves to be processed for veal. quadrispinulatum); small stomach (3) Beef cattle—(i) Amount. Administer worms (Hyostrongylus rubidus): Adult orally 10 mg/kg of body weight (2.3 mg/ and larvae (L2, L3, L4 stages—intes- lb). Retreatment may be needed after 4 tinal mucosal forms) whipworms to 6 weeks. (Trichuris suis); and kidney worms: (ii) Indications for use. For the re- Adult and larvae Stephanurus dentatus. moval and control of stomach worm (iii) Limitations. Swine intended for (4th stage inhibited larvae/type II human consumption must not be ostertagiasis), Ostertagia ostertagi, and slaughtered within 2 days from the last tapeworm, Moniezia benedeni. treatment. (iii) Limitations. Cattle must not be slaughtered within 8 days following [42 FR 59069, Nov. 15, 1977; 43 FR 12311, Mar. last treatment. A withdrawal period 24, 1978. Redesignated at 44 FR 1375, Jan. 5, 1979, and amended at 46 FR 29464, June 2, has not been established for this prod- 1981; 47 FR 15327, Apr. 9, 1982; 48 FR 42809, uct in preruminating calves. Do not Sept. 20, 1983; 49 FR 1983, Jan. 17, 1984; 53 FR use in calves to be processed for veal. 40058, Oct. 13, 1988; 59 FR 26943, May 25, 1994; Federal law restricts this drug to use 61 FR 29478, June 11, 1996; 63 FR 63983, Nov. by or on the order of a licensed veteri- 18, 1998; 66 FR 47960, Sept. 17, 2001; 68 FR narian. 26205, May 15, 2003; 74 FR 17770, Apr. 17, 2009; (4) Goats—(i) Amount. Administer 74 FR 61516, Nov. 25, 2009; 76 FR 17336, Mar. orally 5 mg/kg of body weight (2.3 mg/ 29, 2011; 80 FR 76386, Dec. 9, 2015; 81 FR 22523, Apr. 18, 2016] lb). Retreatment may be needed after 4 to 6 weeks. § 520.905b Fenbendazole granules. (ii) Indications for use. For the removal and control of stomach worms (a) Specifications. Each gram of gran- (adults) Haemonchus contortus and ules contains 222 milligrams (mg) Teladorsagia circumcincta. fenbendazole. (iii) Limitations. Goats must not be (b) Sponsor. See No. 000061 in slaughtered for food within 6 days fol- § 510.600(c) of this chapter. lowing last treatment. Do not use in (c) Special considerations. See § 500.25 lactating goats. of this chapter. (5) Chickens—(i) Amount. Administer (d) Conditions of use—(1) Horses—(i) orally via drinking water at a daily Amount. 5 mg/kilogram (kg) for large dose of 1 mg/kg body weight (0.454 mg/ strongyles, small strongyles, and lb) for 5 consecutive days. pinworms; 10 mg/kg for ascarids. (ii) Indications for use. For the treat- (ii) Indications for use. For the control ment and control of adult Ascaridia of infections of large strongyles galli in broiler chickens and replace- (Strongylus edentatus, S. equinus, S. ment chickens intended to become vulgaris), small strongyles, pinworms breeding chickens, and for the treat- (Oxyuris equi), and ascarids (Parascaris ment and control of adult A. galli and equorum). Heterakis gallinarum in breeding chick- (iii) Limitations. Sprinkle the appro- ens. priate amount of drug on a small (iii) Limitations. Not for use in laying amount of the usual grain ration. Pre- hens and replacement chickens in- pare for each horse individually. With- tended to become laying hens. holding feed or water is not necessary.

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Retreat in 6 to 8 weeks if required. Do § 520.905c Fenbendazole paste. not use in horses intended for food. (a) Specifications. Each gram of paste (2) Dogs—(i) Amount. 50 mg/kg daily contains 100 milligrams (mg) for 3 consecutive days. fenbendazole (10 percent). (ii) Indications for use. For the treat- (b) Sponsor. See No. 000061 in ment and control of ascarids (Toxocara § 510.600(c) of this chapter. canis, Toxascaris leonina), hookworms (c) Related tolerances. See § 556.275 of (Ancylostoma caninum, Uncinaria this chapter. stenocephala), whipworms (Trichuris (d) Special considerations. See § 500.25 vulpis), and tapeworms (Taenia of this chapter. pisiformis). (e) Conditions of use—(1) Horses—(i) (iii) Limitations. Mix the appropriate Indications for use and amounts—(A) For amount of drug with a small amount of control of large strongyles (Strongylus the usual food; dry dog food may re- edentatus, S. equinus, S. vulgaris), small quire slight moistening to facilitate strongyles, pinworms (Oxyuris equi), mixing. Medicated food must be fully and ascarids (Parascaris equorum): 2.3 consumed. mg per pound (/lb) of body weight, or (3) Zoo and wildlife animals—(i) for foals and weanlings (less than 18 Amount. 10 mg/kg per day for 3 days. months of age), 4.6 mg/lb of body (ii) Indications for use. For control of weight. Retreatment at intervals of 6 internal parasites of Felidae and to 8 weeks may be required. Ursidae as follows: (B) For control of arteritis caused by the fourth-stage larvae of S. vulgaris: (A) Lion (Panthera leo) and Tiger 4.6 mg/lb of body weight daily for 5 ( ): Ascarid ( Panthera tigris Toxocara cati, days. Treatment should be initiated in Toxascaris leonina), Hookworm the spring and repeated in 6 months. (Ancylostoma spp.). (C) For treatment of encysted (B) Cheetah (Acinonyx jubatus): Asca- mucosal cyathostome (small strongyle) rid (Toxocara cati, Toxascaris leonina). larvae including early third-stage (C) Puma (Felis concolor), Panther (hypobiotic), late third-stage, and (Panthera spp.), Leopard (Panthera fourth-stage larvae: 4.6 mg/lb of body pardus), Jaguar (Panthera onca): Asca- weight daily for 5 consecutive days. rid (Toxocara cati, Toxascaris leonina), (D) Fenbendazole paste 10 percent Hookworm (Ancylostoma spp.), Tape- may be used concomitantly with ap- 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 removal and control of lungworms (iii) Limitations. Top dress or mix (Dictyocaulus viviparus), stomach with a small portion of food. Must be worms (Haemonchus contortus, fully consumed prior to feeding. Fed- Ostertagia ostertagi, Trichostrongylus eral law restricts this drug to use by or axei), and intestinal worms on the order of a licensed veterinarian. (Bunostomum phlebotomum, Nematodirus Do not use 14 days before or during the helvetianus, Cooperia punctata, C. hunting season. oncophora, Trichostrongylus [44 FR 1375, Jan. 5, 1979, as amended at 47 FR colubriformis, and Oesophagostomum 15327, Apr. 9, 1982; 48 FR 50528, Nov. 2, 1983; 59 radiatum). FR 35252, July 11, 1994; 66 FR 47960, Sept. 17, (iii) Limitations. Cattle must not be 2001; 67 FR 47450, July 19, 2002; 71 FR 19429, slaughtered within 8 days following Apr. 14, 2006; 74 FR 61516, Nov. 25, 2009] last treatment. A withdrawal period

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has not been established for this prod- of fenbendazole per pound of body uct in preruminating calves. Do not weight for mature cattle. use in calves to be processed for veal. (2) Indications for use. For removal [72 FR 24185, May 2, 2007, as amended at 74 and control of infections of lungworms FR 61516, Nov. 25, 2009; 76 FR 17337, Mar. 29, (Dictyocaulus viviparus) and gastro- 2011] intestinal roundworms (Haemonchus contortus, Ostertagia ostertagi, § 520.905d Fenbendazole powder. Trichostrongylus axei, Bunostomum (a) Specifications. Each 2-ounce pack- phlebotomum, Nematodirus helvetianus, et contains 2.27 grams (4 percent) Cooperia oncophora and C. punctata, fenbendazole. Trichostrongylus colubriformis, and (b) Sponsor. See No. 000061 in Oesophagostomum radiatum) in beef cat- § 510.600(c) of this chapter. 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 (Ascaris suum); lungworms tered within 16 days following last (Metastrongylus apri); nodular worms treatment; do not use in dairy cattle of (Oesophagostomum dentatum, O. breeding age. Animals maintained quadrispinulatum); small stomach under conditions of constant worm ex- worms (Hyostrongylus rubidus); posure may require retreatment within whipworms (Trichuris suis); and 6 to 8 weeks. Consult your veterinarian kidneyworms (Stephanurus dentatus— for assistance in the diagnosis, treat- mature and immature). ment, and control of parasitism. (3) Limitations. Thoroughly mix the [51 FR 41783, Nov. 19, 1986, as amended at 54 contents of the packet(s) with swine FR 20787, May 15, 1989; 66 FR 47960, Sept. 17, ration and administer according to 2001; 74 FR 61516, Nov. 25, 2009] label directions. Feed as sole ration for 3 consecutive days. Can be fed to preg- § 520.928 Firocoxib tablets. nant 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. 000010 in sitism. § 510.600(c) of this chapter. [49 FR 18090, Apr. 27, 1984, as amended at 49 (c) Conditions of use—(1) Dogs—(i) FR 20485, May 15, 1984; 66 FR 47960, Sept. 17, Amount. 5 mg/kg (2.27 mg/lb) body 2001; 70 FR 32489, June 3, 2005; 74 FR 61516, weight. Administer once daily for os- Nov. 25, 2009; 83 FR 48945, Oct. 9, 2018] teoarthritis. Administer approximately § 520.905e Fenbendazole blocks. 2 hours before soft tissue or orthopedic surgery. (a) Specifications. (1) Each pound of molasses block contains 750 milligrams (ii) Indications for use. For the control of fenbendazole. of pain and inflammation associated (2) Each pound of protein block con- with osteoarthritis; and for the control tains 750 milligrams of fenbendazole. of postoperative pain and inflamma- (b) Sponsor. See 000061 in § 510.600(c) of tion associated with soft-tissue and or- this chapter. thopedic surgery. (c) Related tolerances. See § 556.275 of (iii) Limitations. Federal law restricts this chapter. this drug to use by or on the order of a (d) Conditions of use—(1) Amount. 0.1 licensed veterinarian. pound of block per 100 pounds of body (2) Horses—(i) Amount. Administer weight per day for 3 days. Total dose one 57-mg tablet to horses weighing 800 for the 3-day period is 2.27 milligrams to 1,300 lb once daily for up to 14 days.

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(ii) Indications for use. For the control § 520.960 Flumethasone. of pain and inflammation associated (a) Specifications. Each tablet con- with osteoarthritis. tains 0.0625 milligram of flumethasone. (iii) Limitations. Do not use in horses (b) Sponsor. See No. 054771 in intended for human consumption. Fed- § 510.600(c) of this chapter. eral law restricts this drug to use by or on the order of a licensed veterinarian. (c) Conditions of use—(1) Amount—(i) Dogs: Administer orally from 0.0625 to [69 FR 51171, Aug. 18, 2004, as amended at 73 0.25 milligram daily in divided doses. FR 2808, Jan. 16, 2008; 73 FR 64885, Oct. 31, (ii) Cats: Administer orally from 2008; 81 FR 67151, Sept. 30, 2016; 84 FR 39183, 0.03125 to 0.125 milligram daily in di- Aug. 9, 2019] vided doses. § 520.930 Firocoxib paste. (2) Indications for use—(i) Dogs: It is used for musculoskeletal conditions (a) Specifications. Each milligram due to inflammation of muscles or (mg) of paste contains 0.82 mg joints and accessory structures, where firocoxib. permanent structural changes do not (b) Sponsors. See No. 000010 in exist, such as arthritis, the disc syn- § 510.600(c) of this chapter. drome, and myositis. (c) Conditions of use in horses—(1) (ii) Dogs and cats: It is used in certain Amount. 0.1 mg per kilogram (0.045 mg acute and chronic dermatoses of vary- per pound) body weight daily for up to ing etiology to help control the pru- 14 days. ritus, irritation, and inflammation as- (2) Indications for use. For the control sociated with these conditions. of pain and inflammation associated (3) Limitations. Federal law restricts with osteoarthritis. this drug to use by or on the order of a (3) Limitations. Do not use in horses licensed veterinarian. intended for human consumption. Fed- eral law restricts this drug to use by or [44 FR 7131, Feb. 6, 1979, as amended at 61 FR on the order of a licensed veterinarian. 5506, Feb. 13, 1996; 79 FR 28821, May 20, 2014]

[71 FR 5788, Feb. 3, 2006, as amended at 84 FR § 520.970 Flunixin. 39183, Aug. 9, 2019] (a) Specifications. (1) Each 10-gram (g) § 520.955 Florfenicol. packet of granules contains flunixin (a) Specifications. Each milliliter meglumine equivalent to 250 milli- (mL) contains 23 milligrams (mg) grams (mg) of flunixin. florfenicol. (2) Each 30-g syringe of paste con- (b) Sponsors. See Nos. 000061, 054925, tains flunixin meglumine equivalent to and 058198 in § 510.600(c) of this chapter. 1,500 mg of flunixin. (c) Related tolerances. See § 556.283 of (b) Sponsors. See sponsors in this chapter. § 510.600(c) of this chapter for use as in (d) Conditions of use in swine—(1) paragraph (c) of this section. Amount. Administer in drinking water (1) No. 000061 for use of products dead libitum at 400 mg per gallon (100 scribed in paragraph (a). parts per million (ppm)) for 5 consecu- (2) No. 061133 for use of the product tive days. described in paragraph (a)(2). (2) Indications for use. For the treat- (c) Conditions of use in horses—(1) ment of swine respiratory disease Amount. 0.5 mg per pound of body (SRD) associated with Actinobacillus weight per day for up to 5 days. pleuropneumoniae, Pasteurella multocida, (2) Indications for use. For alleviation Salmonella choleraesuis and Strepto- of inflammation and pain associated coccus suis. with musculoskeletal disorders. (3) Limitations. Do not slaughter with- (3) Limitations. Do not use in horses in 16 days of last treatment. Federal intended for human consumption. Fed- law restricts this drug to use by or on eral law restricts this drug to use by or the order of a licensed veterinarian. on the order of a licensed veterinarian. [67 FR 78357, Dec. 24, 2002, as amended at 72 [76 FR 53051, Aug. 25, 2011, as amended at 79 FR 262, Jan. 4, 2007; 78 FR 52854, Aug. 27, 2013; FR 74020, Dec. 15, 2014; 84 FR 8972, Mar. 13, 82 FR 12169, Mar. 1, 2017] 2019]

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§ 520.980 Fluoxetine. § 520.1010 Furosemide. (a) Specifications. Each chewable tab- (a) Specifications. (1) Each tablet con- let contains 8, 16, 32, or 64 milligrams tains 12.5 or 50 milligrams (mg) (mg) fluoxetine hydrochloride. furosemide. (b) Sponsor. See No. 055246 in § 510.600 (2) Each bolus contains 2 grams (g) of this chapter. furosemide. (c) Conditions of use in dogs—(1) (3) Each packet of powder contains 2 Amount. 1 to 2 mg per kilogram body g furosemide. weight once daily. (4) Each milliliter of syrup contains (2) Indications for use. For the treat- 10 mg furosemide. ment of canine separation anxiety in (b) Sponsors. See sponsor numbers in conjunction with a behavior modifica- § 510.600(c) of this chapter for use of tion plan. dosage forms and strengths listed in (3) Limitations. Federal law restricts paragraph (a) of this section for uses as this drug to use by or on the order of a in paragraph (d) of this section. licensed veterinarian. (1) No. 000010 for tablets in paragraph (a)(1) of this section for conditions of [72 FR 6463, Feb. 12, 2007, as amended at 79 use in paragraphs (d)(2)(i), (d)(2)(ii)(A), FR 74020, Dec. 15, 2014; 82 FR 21690, May 10, and (d)(3) of this section. 2017] (2) No. 000061 for tablets in paragraph § 520.998 Fluralaner. (a)(1) of this section for conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), (a) Specifications. Each chewable tab- and (d)(3) of this section; for boluses in let contains 112.5, 250, 500, 1000, or 1400 paragraph (a)(2) of this section and milligrams (mg) fluralaner. powder in paragraph (a)(3) of this sec- (b) Sponsor. See No. 000061 in tion for conditions of use in paragraph § 510.600(c) of this chapter. (d)(1) of this section; and for syrup in (c) Conditions of use in dogs—(1) paragraph (a)(4) of this section for con- Amount. Administer orally as a single ditions of use in paragraphs (d)(2)(i) dose every 12 weeks according to the and (d)(2)(ii)(A). label dosage schedule to provide a min- (3) Nos. 058829 and 069043 for use of imum dose of 11.4 mg per pound (/lb) (25 syrup in paragraph (a)(4) of this section mg per kilogram) body weight. May be for conditions of use in paragraph administered every 8 weeks in case of (d)(2)(i) and (d)(2)(ii)(A) of this section. potential exposure to Amblyomma (c) Special considerations. Federal law americanum ticks. restricts this drug to use by or on the (2) Indications for use. Kills adult order of a licensed veterinarian. fleas; for the treatment and prevention (d) Conditions of use. It is used as fol- of flea infestations (Ctenocephalides lows: felis), and the treatment and control of (1) Cattle—(i) Amount. 1 to 2 mg per tick infestations [Ixodes scapularis pound (/lb) body weight using powder, (black-legged tick), Dermacentor or one 2-g bolus per animal, per day. variabilis (American dog tick), and (ii) Indications for use. For treatment Rhipicephalus sanguineus (brown dog of physiological parturient edema of tick)] for 12 weeks in dogs and puppies the mammary gland and associated 6 months of age and older, and weigh- structures. ing 4.4 lb or greater; for the treatment (iii) Limitations. Treatment not to exceed 48 hours post-parturition. Milk and control of A. americanum (lone star taken during treatment and for 48 tick) infestations for 8 weeks in dogs hours after the last treatment must and puppies 6 months of age and older, not be used for food. Cattle must not be and weighing 4.4 lb or greater. slaughtered for food within 48 hours (3) Limitations. Federal law restricts following last treatment. this drug to use by or on the order of a (2) Dogs—(i) Amount. 1 to 2 mg/lb body licensed veterinarian. weight, once or twice daily. [79 FR 37619, July 2, 2014] (ii) Indications for use—(A) For treatment of edema (pulmonary congestion,

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ascites) associated with cardiac insuffi- § 520.1044b Gentamicin sulfate pig ciency and acute noninflammatory tis- pump oral solution. sue edema. (a) Specifications. Each milliliter of (B) For treatment of edema (pul- pig pump oral solution contains monary congestion, ascites) associated gentamicin sulfate equivalent to 4.35 with cardiac insufficiency. milligrams of gentamicin. (3) Cats—(i) Amount. 1 to 2 mg/lb body (b) Sponsor. See Nos. 000061 and 016592 weight, once or twice daily. in § 510.600(c) of this chapter. (ii) Indications for use. For treatment (c) Related tolerances. See § 556.300 of of edema (pulmonary congestion, asci- this chapter. tes) associated with cardiac insuffi- (d) Conditions of use—(1) Amount. Ad- ciency and acute noninflammatory tis- minister 1.15 milliliters of pig pump sue edema. oral solution (5 milligrams of gentamicin) orally per pig one time. [66 FR 47960, Sept. 17, 2001, as amended at 69 (2) Indications for use. In neonatal FR 74419, Dec. 14, 2004; 70 FR 50182, Aug. 26, swine 1 to 3 days of age for control and 2005; 70 FR 76396, Dec. 27, 2005; 74 FR 61516, treatment of colibacillosis caused by Nov. 25, 2009; 78 FR 17596, Mar. 22, 2013; 81 FR strains of E. coli sensitive to 17607, Mar. 30, 2016] gentamicin. (3) Limitations. For use in neonatal § 520.1044 Gentamicin sulfate oral dos- swine only. Do not slaughter treated age forms. swine for food for at least 14 days following treatment. § 520.1044a Gentamicin sulfate oral solution. [49 FR 572, Jan. 5, 1984, as amended at 52 FR (a) Specifications. Each milliliter of 7832, Mar. 13, 1987; 62 FR 29011, May 29, 1997; 78 FR 17596, Mar. 22, 2013; 81 FR 22523, Apr. 18, aqueous solution contains gentamicin 2016] sulfate equivalent to 50 milligrams of gentamicin. § 520.1044c Gentamicin sulfate powder. (b) Sponsor. See Nos. 000061 and 054925 (a) Specifications. Each gram of pow- in § 510.600(c) of this chapter. der contains gentamicin sulfate equiv- (c) Related tolerances. See § 556.300 of alent to: this chapter. (1) 16.7, 66.7, or 333.3 milligrams (mg) (d) Conditions of use—(1) Amount. gentamicin. Colibacillosis: 1 milliliter per 2 gallons (2) 333.3 mg gentamicin. of drinking water for 3 consecutive (b) Sponsors. See sponsors in days, to provide 0.5 milligram/pound/ § 510.600(c) of this chapter for use as in day; swine dysentery: 1 milliliter per 1 paragraph (d) of this section as follows: gallon of drinking water for 3 consecu- (1) No. 000061 for products described tive days, to provide 1.0 milligram/ in paragraph (a)(1) of this section. pound/day. (2) Nos. 016592 and 061133 for product (2) Indications for use. In weanling described in paragraph (a)(2) of this section. swine for control and treatment of (c) Related tolerances. See § 556.300 of colibacillosis caused by strains of E. this chapter. coli sensitive to gentamicin, and in (d) Conditions of use in swine—(1) swine for control and treatment of Amount. Administer in drinking water swine dysentery associated with for 3 consecutive days as follows: Treponema hyodysenteriae. (i) For colibacillosis: Gentamicin sul- (3) Limitations. Do not slaughter fate equivalent to 25 mg of gentamicin treated swine for food for at least 3 per gallon of drinking water to provide days following treatment. Federal law 0.5 mg per pound of body weight per restricts this drug to use by or on the day; order of a licensed veterinarian. (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 gentamicin per gallon of drinking 14332, Apr. 11, 1984; 52 FR 7832, Mar. 13, 1987; water to provide 1 mg per pound of 62 FR 34169, June 25, 1997; 71 FR 13542, Mar. body weight per day. Treatment may 16, 2006; 81 FR 94989, Dec. 27, 2016] be repeated if dysentery recurs.

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(2) Indications for use. For control and not be administered beyond the rec- treatment of colibacillosis in weanling ommended treatment period without swine caused by strains of Escherichia the addition of milk or milk replacer. coli sensitive to gentamicin, and for control and treatment of swine dys- [79 FR 28821, May 20, 2014] entery associated with Treponema § 520.1084 Grapiprant. hyodysenteriae. (3) Limitations. Withdrawal period: 10 (a) Specifications. Each tablet con- days. Federal law restricts this drug to tains 20, 60, or 100 milligrams (mg) use by or on the order of a licensed vet- grapiprant. erinarian. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. [77 FR 4226, Jan. 27, 2012, as amended at 81 FR 94989, Dec. 27, 2016; 83 FR 48945, Sept. 28, (c) Conditions of use in dogs—(1) 2018; 84 FR 8972, Mar. 13, 2019] Amount. Administer 0.9 mg/lb (2 mg/kg) once daily by mouth. § 520.1060 Glucose and glycine. (2) Indications for use. For the control (a) Specifications. Each packet of pow- of pain and inflammation associated der contains 8.82 grams sodium chlo- with osteoarthritis in dogs. ride, 4.20 grams potassium phosphate, (3) Limitations. Federal law restricts 0.5 gram citric acid anhydrous, 0.12 this drug to use by or on the order of a gram potassium citrate, 6.36 grams licensed veterinarian. aminoacetic acid (glycine), and 44.0 [81 FR 36789, June 8, 2016, as amended at 83 grams glucose. FR 14587, Apr. 5, 2018] (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 520.1100 Griseofulvin. (c) Conditions of use in calves—(1) (a) Specifications—(1) The powder Amount. Dissolve each packet in 2 complies with U.S.P. for griseofulvin, quarts of warm water and administer microsize. to each calf as follows: (2) Each bolus contains 2.5 grams (i) Scouring and/or dehydrated calves. griseofulvin. Feed 2 quarts of solution, twice daily for 2 days (four feedings). No milk or (3) Each tablet contains 125 or 500 milk replacer should be fed during this milligrams griseofulvin. period. For the next four feedings (days (b) Sponsors. See sponsors in 3 and 4), use 1 quart of solution to- § 510.600(c) of this chapter. gether with 1 quart of milk replacer. (1) No. 000061 for use of products de- Thereafter, feed as normal. scribed in paragraph (a) for use as in (ii) Newly purchased calves. Feed 2 paragraph (d) of this section. quarts of solution instead of milk as (2) No. 061133 for use of the powder the first feed upon arrival. For the next described in paragraph (a)(1) for use as scheduled feeding, use 1 quart of solu- in paragraphs (d)(1)(i)(A) and (d)(1)(ii) tion mixed together with 1 quart of of this section. milk or milk replacer. Thereafter, feed (c) Special considerations. Federal law as normal. restricts this drug to use by or on the (2) Indications for use. For control of order of a licensed veterinarian. dehydration associated with diarrhea (d) Conditions of use—(1) Horses—(i) (scours); and as an early treatment at Amount and indications for use—(A) For the first signs of scouring. It may also equine ringworm infection caused by be used as followup treatment fol- Trichophyton equinum or Microsporum lowing intravenous fluid therapy. gypseum, administer soluble powder de- (3) Limitations. The product should scribed in paragraph (a)(1) of this sec- not be used in animals with severe de- tion daily as a drench or as a top dress- hydration (down, comatose, or in a ing on feed for not less than 10 days as state of shock). Such animals need in- follows: adults, 2.5 grams; yearlings, travenous therapy. A veterinarian 1.25 to 2.5 grams; and foals, 1.25 grams. should be consulted in severely scour- (B) For treating ringworm infection ing calves. The product is not nutri- caused by T. equinum, administer tionally complete if administered by boluses described in paragraph (a)(2) of itself for long periods of time. It should this section daily for not less than 10

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days as follows: adults, 1 bolus; year- follows: For animals weighing up to 100 lings, one-half to 1 bolus; and foals, pounds: 1⁄2 fluid ounce; for animals one-half bolus. weighing 100 to 150 pounds: 3⁄4 fluid (ii) Limitations. Do not use in horses ounce; for animals weighing 150 to 200 intended for human consumption. pounds: 1 fluid ounce; for animals (2) Dogs and cats: (i) Amount. 125- and weighing 200 to 300 pounds: 1 1⁄2 fluid 500-milligram tablets administered ounces; for animals weighing 300 to 450 orally as follows: pounds: 2 fluid ounces; for animals (A) Daily (single or divided) dose as weighing 450 to 700 pounds: 3 fluid follows: For animals weighing up to 6 ounces; for animals weighing 700 to pounds: 62.5 milligrams; for animals 1,000 pounds: 4 fluid ounces; for animals weighing 6 to 18 pounds: 125 milli- weighing 1,000 to 1,200 pounds: 5 fluid grams; for animals weighing 18 to 36 ounces; for animals weighing over 1,200 pounds: 250 milligrams; for animals pounds: 6 fluid ounces. Retreat in 3 to weighing 36 to 48 pounds: 375 milli- 4 weeks. grams; for animal weighing 48 to 75 (2) Indications for use. For control of pounds: 500 milligrams. gastrointestinal roundworms of the (B) Weekly (single) dose: If experi- genera Haemonchus, Ostertagia, ence indicates that treatment is more Trichostrongylus, and Cooperia. effective for the drug given in large (3) Limitations. Do not treat dairy doses, administer at intervals of 7 to 10 animals of breeding age. Do not treat days, a dose equal to 10 milligrams/ within 1 week of slaughter. pound of body weight × body weight × number of days between treatments. [40 FR 13838, Mar. 27, 1975, as amended at 45 FR 10333, Feb. 15, 1980; 46 FR 48642, Oct. 2, Dosage should be adjusted according to 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, response. Administer additional dose Nov. 19, 1997; 78 FR 28822, May 20, 2014] after the animal is free of infection. (ii) Indications for use. For treatment § 520.1120b Haloxon boluses. of fungal infections of the skin, hair, (a) Specifications. Each bolus contains and claws caused by Trichophyton 10.1 grams of haloxon. mentagrophytes, T. rubrum, T. (b) Sponsor. See No. 000061 in schoenleini, T. sulphurem, T. verrucosum, § 510.600(c) of this chapter. T. interdigitale, Epidermophyton (c) Related tolerances. See § 556.310 of floccosum, Microsporum gypseum, M. this chapter. canis, M. audouini. (d) Conditions of use in cattle—(1) [40 FR 13838, Mar. 27, 1975, as amended at 41 Amount. Administered one bolus per 500 FR 42948, Sept. 29, 1976; 43 FR 28458, June 30, pounds body weight (35 to 50 milli- 1978; 52 FR 7832, Mar. 13, 1987; 54 FR 30205, grams per kilogram of body weight). July 19, 1989; 71 FR 38073, July 5, 2006; 77 FR Retreat in 3 to 4 weeks. 28253, May 14, 2012; 78 FR 28822, May 20, 2014; (2) Indications for use. For control of 84 FR 8972, Mar. 13, 2019] gastrointestinal roundworms of the § 520.1120 Haloxon oral dosage forms. genera Haemonchus, Ostertagia, Trichostrongylus, and Cooperia. § 520.1120a Haloxon drench. (3) Limitations. Do not treat dairy (a) Specifications. Each packet con- animals of breeding age or older. Do tains 141.5 grams haloxon. not treat within 1 week of slaughter. (b) Sponsor. See No. 000061 in [40 FR 13838, Mar. 27, 1975, as amended at 44 § 510.600(c) of this chapter. FR 61591, Oct. 29, 1979; 46 FR 48642, Oct. 2, (c) Special considerations. Do not use 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, any drug, insecticide, pesticide, or Nov. 19, 1997; 78 FR 28822, May 20, 2014] other chemical having cholinesterase- inhibiting activity either simulta- § 520.1130 Hetacillin. neously or within a few days before or (a) Specifications. (1) Each capsule or after treatment with haloxon. tablet contains hetacillin potassium (d) Related tolerances. See § 556.310 of equivalent to 50, 100, or 200 milligrams this chapter. (mg) of ampicillin. (e) Conditions of use in cattle—(1) (2) Each milliliter of suspension con- Amount. Dissolve each packet in 32 tains hetacillin potassium equivalent fluid ounces of water and administer as to 50 mg of ampicillin.

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(b) Sponsor. See No. 000010 in (2) Indications for use. Kills adult fleas § 510.600(c) of this chapter. and is indicated for the treatment of (c) Conditions of use in dogs and cats— flea infestations on dogs and puppies 10 (1) Amount—(i) Dogs. Administer 5 mg weeks of age and older and weighing 4 per pound (/lb) of body weight orally, lb or greater. twice daily. In severe infections, ad- (3) Limitations. Do not give to puppies minister 5 mg/lb three times daily, or younger than 10 weeks of age or to dogs up to 10 mg/lb twice daily. For stub- weighing less than 4 lb. Do not give born urinary tract infections, admin- more than one tablet a day. ister up to 20 mg/lb twice daily. [80 FR 18775, Apr. 8, 2015] (ii) Cats. Administer 50 mg twice daily. § 520.1157 Iodinated casein. (2) Indications for use. For the treat- (a) Specifications. Each 1-gram tablet ment of respiratory tract infections, contains 25 milligrams of iodinated ca- urinary tract infections, gastro- sein. intestinal infections, skin infections, (b) Sponsor. See No. 017762 in soft tissue infections, and postsurgical § 510.600(c) of this chapter. infections associated with strains of or- (c) Conditions of use—(1) Amount. 1⁄5 to ganisms susceptible to hetacillin po- 1 tablet per 10 pounds of body weight tassium. (equivalent to 0.5 to 2.5 milligrams of (3) Limitations. Federal law restricts iodinated casein per pound of body this drug to use only by or on the order weight). of a licensed veterinarian. (2) Indications for use. For dogs for ap- [75 FR 10166, Mar. 5, 2010] parent decreased thyroid activity where the signs are alopecia, scaliness § 520.1150 Imepitoin. of the skin surface, loss of hair, seborrhea, thickening of the skin, (a) Specifications. Each tablet con- hyperpigmentation, and lethargy. tains 100 or 400 milligrams (mg) (3) Limitations. Federal law restricts imepitoin. this drug to use by or on the order of a (b) Sponsor. See No. 000010 in licensed veterinarian. § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Ad- [49 FR 22469, May 30, 1984, as amended at 78 minister orally twice daily, approxi- FR 28822, May 20, 2014] mately 12 hours apart, at a dose of 13.6 § 520.1158 Iodochlorhydroxyquin. mg per pound (30 mg/kg) of body weight. Initiate therapy starting 2 days (a) Specifications. Each bolus contains prior to the day of the expected noise 10 grams of iodochlorhydroxyquin. event and continuing through the noise (b) Sponsor. See No. 054771 in § 510.600 event. (c) of this chapter. (2) Indications for use. For the treat- (c) Conditions of use—(1) Amount. 1 ment of noise aversion in dogs. bolus (10 grams) daily for a 1,000-pound (3) Limitations. Federal law restricts horse. (2) For treatment this drug to use by or on the order of a Indications for use. of equine diarrhea. licensed veterinarian. (3) Limitations. Do not use in horses [84 FR 12494, Apr. 2, 2019] intended for human consumption. Fed- eral law restricts this drug to use by or § 520.1156 Imidacloprid. on the order of a licensed veterinarian. (a) Specifications. Each chewable tab- [48 FR 8054, Feb. 25, 1983, as amended at 50 let contains 7.5 or 37.5 milligrams (mg) FR 41489, Oct. 11, 1985; 78 FR 28822, May 20, imidacloprid. 2014] (b) Sponsor. See No. 000859 in § 510.600(c) of this chapter. § 520.1189 Itraconazole. (c) Conditions of use in dogs—(1) (a) Specifications. Each milliliter Amount. Administer daily one 7.5-mg (mL) of solution contains 10 milligrams chewable tablet to dogs weighing 4 to (mg) of itraconazole. 22 pounds (lb) or one 37.5-mg chewable (b) Sponsor. See No. 058198 in table to dogs weighing 23 to 110 lb. § 510.600(c) of this chapter.

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(c) Conditions of use—(1) Amount. Ad- third- and fourth-stage larvae): minister 5 mg/kilogram (kg) (0.5 mL/ Parascaris equorum; Hairworms (adults): kg) of body weight once daily on alter- Trichostrongylus axei; Large mouth nating weeks for 3 treatment cycles. Stomach Worms (adults): Habronema (2) Indications for use. For the treat- muscae; Bots (oral and gastric stages): ment of dermatophytosis caused by Gasterophilus spp. including G. Microsporum canis in cats. intestinalis and G. nasalis; Lungworms (3) Limitations. Federal law restricts (adults and fourth-stage larvae): this drug to use by or on the order of a Dictyocaulus arnfieldi; Intestinal licensed veterinarian. Threadworms (adults): Strongyloides [82 FR 12169, Mar. 1, 2017] westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous § 520.1192 Ivermectin paste. third-stage larvae; Dermatitis caused (a) Specifications. Each milligram by neck threadworm microfilariae, (mg) of paste contains 0.0187 mg (1.87 Onchocerca sp. percent) or 0.00153 mg (0.153 percent) of (iii) Limitations. For oral use only. Do ivermectin. not use in horses intended for human (b) Sponsors. See sponsors in consumption. § 510.600(c) of this chapter for use as in paragraph (e) of this section: (2) Cattle—(i) Amount. 23 milligrams (1) No. 000010 for use of a 1.87 percent per 250 pounds of body weight. paste as in (e)(1) of this section and a (ii) Indications for use. It is used in 0.153 percent paste for use as in para- cattle for the treatment and control of graph (e)(2) of this section. gastrointestinal roundworms (adults (2) Nos. 000859, 051311, 054925, and and fourth-stage larvae) (Ostertagia 061133 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. (ii) Indications for use. For treatment (first, second, and third instars) and control of Large Strongyles (Hypoderma bovis, H. lineatum); and (adults): Strongylus vulgaris (also early sucking lice (Linognathus vituli, forms in blood vessels), S. edentatus Haematopinus eurysternus). (also tissue stages), S. equinus, (iii) Limitations. For oral use only. Do Triodontophorus spp. including T. not treat cattle within 24 days of brevicauda and T. serratus, and slaughter. Because withdrawal time in Craterostomum acuticaudatum; Small milk has not been established, do not Strongyles (adults, including those re- use in female dairy cattle of breeding sistant to some benzimidazole class age. compounds): Coronocyclus spp. including C. coronatus, C. labiatus, and C. [49 FR 22275, May 29, 1984, as amended at 50 labratus, Cyathostomum spp. including FR 27819, July 8, 1985; 51 FR 44449, Dec. 10, 1986; 53 FR 51273, Dec. 21, 1988; 62 FR 63270, C. catinatum and C. pateratum, Nov. 28, 1997; 65 FR 70661, Nov. 27, 2000; 67 FR Cylicocyclus spp. including C. insigne, C. 71820, Dec. 3, 2002; 68 FR 43294, July 22, 2003; leptostomum, C. nassatus, and C. 69 FR 59131, Oct. 4, 2004; 70 FR 8514, Feb. 22, brevicapsulatus, Cylicodontophorus spp., 2005; 71 FR 40010, July 14, 2006; 71 FR 67298, Cylicostephanus spp. including C. Nov. 21, 2006; 73 FR 34184, June 17, 2008; 74 FR calicatus, C. goldi, C. longibursatus, and 6542, Feb. 10, 2009; 78 FR 17596, Mar. 22, 2013; C. minutus, and Petrovinema poculatum; 84 FR 8972, Mar. 13, 2019; 84 FR 39183, Aug. 9, Small Strongyles (fourth-stage larvae); 2019] Pinworms (adults and fourth-stage larvae): Oxyuris equi; Ascarids (adults and

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§ 520.1193 Ivermectin tablets and § 520.1194 Ivermectin meal. chewables. (a) Specifications. Each gram of meal (a) Specifications. (1) Each tablet or contains 6 milligrams ivermectin (0.6 chewable contains 68, 136, or 272 percent). micrograms (mcg) ivermectin. (b) Sponsor. See No. 017135 in (2) Each chewable contains 55 or 165 § 510.600(c) of this chapter. mcg ivermectin. (c) Special considerations. See § 500.25 (b) Sponsors. See sponsors in of this chapter. § 510.600(c) of this chapter for use as in (d) Conditions of use in horses—(1) paragraph (d) of this section. Amount. Administer 136 micrograms (1) No. 000010 for use of tablets or (mcg) ivermectin per pound (/lb) body chewables described in paragraph (a)(1) weight (300 mcg/kilogram) as a single as in paragraph (d)(1) and chewables de- dose on approximately 2 lb grain or scribed in paragraph (a)(2) as in para- sweet feed. graph (d)(2) of this section. (2) Indications for use. For treatment (2) Nos. 051311 and 069043 for use of and control of Large Strongyles tablets described in paragraph (a)(1) as (adults): Strongylus vulgaris (also early in paragraph (d)(1) of this section. forms in blood vessels), S. edentatus (c) Special considerations. Federal law (also tissue stages), S. equinus, restricts this drug to use by or on the Triodontophorus spp. including T. order of a licensed veterinarian. brevicauda and T. serratus, and (d) Conditions of use—(1) Dogs. For use Craterostomum acuticaudatum; Small in dogs 6 weeks of age and older as fol- Strongyles (adults, including those re- lows: sistant to some benzimidazole class (i) Amount. 6.0 mcg per kilogram (kg) compounds): Coronocyclus spp. includ- of body weight (2.72 mcg per pound ing C. coronatus, C. labiatus, and C. (lb)), minimum. Up to 25 lb, 68 mcg; 26 labratus, Cyathostomum spp. including to 50 lb, 136 mcg; 51 to 100 lb, 272 mcg; C. catinatum and C. pateratum, over 100 lb, a combination of the appro- Cylicocyclus spp. including C. insigne, C. priate tablets. Administer at monthly leptostomum, C. nassatus, and C. dosing intervals. brevicapsulatus, Cylicodontophorus spp., (ii) Indications for use. To prevent ca- Cylicostephanus spp. including C. nine heartworm disease by eliminating calicatus, C. goldi, C. longibursatus, and the tissue stage of heartworm larvae C. minutus, and Petrovinema poculatum; (Dirofilaria immitis) for 1 month (30 Small Strongyles (fourth-stage larvae); days) after infection. Pinworms (adults and fourth stage lar- (2) Cats. For use in cats 6 weeks of vae): Oxyuris equi; Ascarids (adults and age and older as follows: third- and fourth-stage larvae): (i) Amount. Up to 2.3 kilograms (up to Parascaris equorum; Hairworms (adults): 5 lb), 55 mcg; 2.3 to 6.8 kilograms (5 to Trichostrongylus axei; Large Mouth 15 lb), 165 mcg; over 6.8 kilograms (15 Stomach Worms (adults): Habronema lb), a combination of the appropriate muscae; Bots (oral and gastric stages): chewables (recommended minimum Gasterophilus spp. including G. dose of 24 mcg/kg of body weight (10.9 intestinalis and G. nasalis; Lungworms mcg/lb)). Administer once a month. (adults and fourth-stage larvae): (ii) Indications for use. To prevent fe- Dictyocaulus arnfieldi; Intestinal line heartworm disease by eliminating Threadworms (adults): Strongyloides the tissue stage of heartworm larvae westeri; Summer Sores caused by Dirofilaria immitis for a month (30 days) Habronema and Draschia spp. cutaneous after infection, and for removal and third-stage larvae; Dermatitis caused control of adult and immature (L4) hookworms Ancylostoma tubaeforme and by neck threadworm microfilariae, A. braziliense. Onchocerca sp. Limitations. Do not use in horses in- [67 FR 11230, Mar. 13, 2002, as amended at 67 tended for human consumption. FR 21996, May 2, 2002; 69 FR 43735, July 22, 2004; 81 FR 17607, Mar. 30, 2016; 84 FR 39183, [70 FR 1817, Jan. 11, 2005, as amended at 70 Aug. 9, 2019] FR 19262, Apr. 13, 2005]

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§ 520.1195 Ivermectin liquid. Gasterophilus spp. including G. (a) Specifications—(1) Each milliliter intestinalis and G. nasalis; Lungworms (mL) contains 10 milligrams (mg) (adults and fourth-stage larvae): ivermectin. Dictyocaulus arnfieldi; Intestinal (2) Each mL of micellar solution con- Threadworms (adults), Strongyloides tains 0.8 mg ivermectin. westeri; Summer Sores caused by (b) Sponsors. See sponsor numbers in Habronema and Draschia spp. cutaneous § 510.600(c) of this chapter. third-stage larvae; Dermatitis caused (1) Nos. 000010, 000859, 054925, and by neck threadworm microfilariae, 058005 for use of product described in Onchocerca sp. paragraph (a)(1) of this section as in (B) Large Strongyles (Strongylus paragraphs (e)(1)(i), (e)(1)(ii)(A), and equinus (adult), S. vulgaris (adult and (e)(1)(iii) of this section. arterial larval stages), S. endentatus (2) No. 058829 for use of product de- (adult and migrating tissue stages), scribed in paragraph (a)(1) of this sec- Triodontophorus spp. (adult)); Small tion as in paragraphs (e)(1)(i), Strongyles including those resistant to (e)(1)(ii)(B), and (e)(1)(iii) of this sec- some benzimidazole class compounds tion. (Cyathostomum spp. (adult and fourth- (3) Nos. 000010 and 058829 for use of stage larvae), Cylicocyclus spp., product described in paragraph (a)(2) of Cylicodontophorus spp., Cylicostephanus this section as in paragraph (e)(2) of spp.); Pinworms (Oxyuris equi (adult this section. and fourth-stage larvae)); Ascarids (c) Related tolerances. See § 556.344 of (Parascaris equorum (adult and third- this chapter. and fourth-stage larvae)); Hairworms (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.

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(iii) Limitations. For use in sheep pounds (lb) (125 kilograms (kg)) and not only. Do not use in other animal spe- more than 660 lb (300 kg) on the day of cies as severe adverse reactions, in- administration. cluding fatalities in dogs, may result. (2) Indications. For treatment and Do not treat sheep within 11 days of control, throughout the grazing season slaughter. (approximately 130 days), of gastro- [67 FR 50597, Aug. 5, 2002, as amended at 69 intestinal roundworms Haemonchus FR 57173, Sept. 24, 2004; 71 FR 13542, Mar. 16, placei, Ostertagia ostertagi (including in- 2006; 71 FR 38072, July 5, 2006; 72 FR 9456, Feb. hibited fourth-stage larvae), 21, 2008; 78 FR 17596, Mar. 22, 2013; 79 FR 10964, Trichostrongylus axei, T. colubriformis, Feb. 27, 2014; 84 FR 39183, Aug. 9, 2019] Cooperia spp., Nematodirus helvetianus, § 520.1196 Ivermectin and pyrantel Bunostomum phlebotomum, tablets. Oesophagostomum radiatum; lungworms (a) Specifications. Each chewable tab- Dictyocaulus viviparus; grubs Hypoderma let contains either 68 micrograms (μg) spp.; sucking lice Linognathus vituli, of ivermectin and 57 milligrams (mg) of Solenopotes capillatus; mange mites pyrantel (as pamoate salt), or 136 μg Psoroptes ovis, Sarcoptes scabiei, and and 114 mg, or 272 μg and 227 mg, re- ticks Amblyomma americanum. spectively. (3) Limitations. The bolus was specifi- (b) Sponsors. See Nos. 000010, 051311, cally designed for use in cattle; do not and 063604 in § 510.600(c) of this chapter. use in other animal species. Calves (c) Conditions of use—(1) Dogs—(i) must be ruminating and older than 12 Amount. Administer a minimum of 6 μg weeks of age. Do not administer to of ivermectin and 5 mg of pyrantel per calves weighing less than 275 lb (125 kilogram (2.72 μg and 2.27 mg per kg). Do not administer a damaged pound) of body weight monthly. 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 hookworms Ancylostoma caninum, A. [61 FR 67452, Dec. 23, 1996, as amended at 62 braziliense, and Uncinaria stenocephala. FR 63270, Nov. 28, 1997; 65 FR 45876, July 26, (iii) Limitations. Federal law restricts 2000; 84 FR 39183, Aug. 9, 2019] this drug to use by or on the order of a licensed veterinarian. § 520.1198 Ivermectin and praziquantel (2) [Reserved] paste. (a) Specifications. Each milligram [58 FR 8542, Feb. 16, 1993, as amended at 61 FR 15186, Apr. 5, 1996; 61 FR 59004, Nov. 20, (mg) of paste contains: 1996; 62 FR 63270, Nov. 28, 1997; 66 FR 35756, (1) 0.0155 mg (1.55 percent) ivermectin July 9, 2001; 67 FR 21996, May 2, 2002; 68 FR and 0.0775 mg (7.75 percent) 55823, Sept. 29, 2003; 78 FR 28822, May 20, 2014; praziquantel. 84 FR 39183, Aug. 9, 2019] (2) 0.0187 mg (1.87 percent) ivermectin § 520.1197 Ivermectin sustained-re- and 0.1403 mg (14.03 percent) lease bolus. praziquantel. (a) Specifications. Each sustained-re- (3) 0.0187 mg (1.87 percent) ivermectin lease bolus contains 1.72 grams of and 0.2338 mg (23.38 percent) ivermectin. praziquantel. (b) Sponsor. See No. 000010 in (b) Sponsors. See sponsors in § 510.600(c) of this chapter. § 510.600(c) of this chapter for uses as in (c) Related tolerances. See § 556.344 of paragraph (d) of this section.— this chapter. (1) No. 000010 for use of product de- (d) Conditions of use in ruminating scribed in paragraph (a)(1) of this sec- calves—(1) Amount. Administer one tion as in paragraphs (d)(1)(i), (d)(2)(i) bolus per calf weighing at least 275 and (d)(3) of this section.

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(2) No. 051311 for use of product de- (ii) For treatment and control of the scribed in paragraph (a)(2) of this sec- following parasites: Tapeworms— tion as in paragraphs (d)(1)(ii), Anoplocephala perfoliata; Large (d)(2)(ii), and (d)(3) of this section. Strongyles (adults)—Strongylus vulgaris (3) No. 000010 for use of products de- (also early forms in blood vessels), S. scribed in paragraph (a)(3) of this sec- edentatus (also tissue stages), S. tion as in paragraphs (d)(1)(iii), equinus, Triodontophorus spp.; Small (d)(2)(iii) and (d)(3) of this section. Strongyles (adults, including those re- (c) Special considerations. See § 500.25 sistant to some benzimidazole class of this chapter. compounds)—Cyathostomum spp.; (d) Conditions of use in horses—(1) Cylicocyclus spp.; Cylicostephanus spp., Amount—(i) 200 micrograms (mcg) per Cylicodontophorus spp.; Small kilogram (/kg) ivermectin (91 mcg per Strongyles—fourth-stage larvae; pound (/lb)) and 1 mg/kg praziquantel Pinworms (adults and fourth-stage lar- (454 mcg/lb) body weight. vae)—Oxyuris equi; Ascarids (adults and (ii) 200 mcg/kg ivermectin (91 mcg/lb) third- and fourth-stage larvae)— and 1.5 mg/kg praziquantel (681 mcg/lb) Parascaris equorum; Hairworms body weight. (adults)—Trichostrongylus axei; Large- (iii) 200 mcg/kg ivermectin (91 mcg/lb) mouth Stomach Worms (adults)— and 2.5 mg/kg praziquantel (1.14 mg/lb). Habronema muscae; Bots (oral and gas- (2) —(i) For treat- Indications for use tric stages)—Gasterophilus spp.; ment and control of the following Lungworms (adults and fourth-stage parasites: Tapeworms—Anoplocephala larvae)—Dictyocaulus arnfieldi; Intes- perfoliata; Large Strongyles (adults)— tinal Threadworms (adults)— Strongylus vulgaris (also early forms in Strongyloides westeri; Summer Sores blood vessels), S. edentatus (also tissue caused by Habronema and Draschia spp. stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, cutaneous third-stage larvae; Derma- and Craterostomum acuticaudatum; titis caused by neck threadworm Small Strongyles (adults, including microfilariae, Onchocerca sp. those resistant to some benzimidazole (iii) For treatment and control of the class compounds)—Coronocyclus spp. in- following parasites in horses over 5 cluding C. coronatus, C. labiatus, and C. months of age: Tapeworms— labratus; Cyathostomum spp. including Anoplocephala perfoliata; Large C. catinatum and C. pateratum; Strongyles (adults)—Strongylus vulgaris Cylicocyclus spp. including C. insigne, C. (also early forms in blood vessels), S. leptostomum, C. nassatus, and C. edentatus (also tissue stages), S. brevicapsulatus; Cylicodontophorus spp.; equinus, Triodontophorus spp. including Cylicostephanus spp. including C. T. brevicauda and T. serratus, and calicatus, C. goldi, C. longibursatus, and Craterostomum acuticaudatum; Small C. minutus, and Petrovinema poculatum; Strongyles (adults, including those re- Small Strongyles—fourth-stage larvae; sistant to some benzimidazole class Pinworms (adults and fourth-stage lar- compounds)—Coronocyclus spp. includ- vae)—Oxyuris equi; Ascarids (adults and ing C. coronatus, C. labiatus, and C. third- and fourth-stage larvae)— labratus; Cyathostomum spp. including Parascaris equorum; Hairworms C. catinatum and C. pateratum; (adults)—Trichostrongylus axei; Large- Cylicocyclus spp. including C. insigne, C. mouth Stomach Worms (adults)— leptostomum, C. nassatus, and C. Habronema muscae; Bots (oral and gas- brevicapsulatus; Cylicodontophorus spp.; tric stages)—Gasterophilus spp. includ- Cylicostephanus spp. including C. ing G. intestinalis and G. nasalis; calicatus, C. goldi, C. longibursatus, and Lungworms (adults and fourth-stage C. minutus, and Petrovinema poculatum; larvae)—Dictyocaulus arnfieldi; Intes- Small Strongyles—fourth-stage larvae; tinal Threadworms (adults)— Pinworms (adults and fourth-stage lar- Strongyloides westeri; Summer Sores vae)—Oxyuris equi; Ascarids (adults and caused by Habronema and Draschia spp. third- and fourth-stage larvae)— cutaneous third-stage larvae; Derma- Parascaris equorum; Hairworms titis caused by neck threadworm (adults)—Trichostrongylus axei; Large- microfilariae of Onchocerca sp. mouth Stomach Worms (adults)—

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Habronema muscae; Bots (oral and gas- hookworm (Ancylostoma caninum, tric stages)—Gasterophilus spp. includ- Uncinaria stenocephala, Ancylostoma ing G. intestinalis and G. nasalis; braziliense) and tapeworm (Dipylidium Lungworms (adults and fourth-stage caninum, Taenia pisiformis) infections. larvae)—Dictyocaulus arnfieldi; Intes- (3) Limitations. Federal law restricts tinal Threadworms (adults)— this drug to use by or on the order of a Strongyloides westeri; Summer Sores licensed veterinarian. caused by Habronema and Draschia spp. [71 FR 65052, Nov. 7, 2006, as amended at 78 cutaneous third-stage larvae; Derma- FR 28822, May 20, 2014; 83 FR 14587, Apr. 5, titis caused by neck threadworm 2018] microfilariae of Onchocerca sp. (3) Limitations. For oral use only. Do § 520.1200 Ivermectin, fenbendazole, not use in horses intended for human and praziquantel tablets. consumption. (a) Specifications. Each chewable tab- [68 FR 55309, Sept. 25, 2003, as amended at 69 let contains either: FR 49808, Aug. 12, 2004; 70 FR 65835, Nov. 1, (1) 68 micrograms (μg) ivermectin, 2005; 79 FR 37619, July 2, 2014; 84 FR 39183, 1.134 grams fenbendazole, and 57 milli- Aug. 9, 2019] grams (mg) praziquantel; or (2) 27 μg ivermectin, 454 mg § 520.1199 Ivermectin, pyrantel, and praziquantel tablets. fenbendazole, and 23 mg praziquantel. (b) Sponsor. See No. 000061 in (a) Specifications. Each chewable tab- § 510.600(c) of this chapter. let or soft chewable tablet contains: (c) Conditions of use in dogs—(1) (1) 34 micrograms (mcg) ivermectin, Amount. Administer tablets to provide 28.5 milligrams (mg) pyrantel pamoate, 6 μg per kilogram (/kg) ivermectin, 100 and 28.5 mg praziquantel; mg/kg fenbendazole, and 5 mg/kg (2) 68 mcg ivermectin, 57 mg pyrantel praziquantel. pamoate, and 57 mg praziquantel; (2) Indications for use. For the treat- (3) 136 mcg ivermectin, 114 mg ment and control of adult Toxocara pyrantel pamoate, and 114 mg canis (roundworm), Ancylostoma praziquantel; or caninum (hookworm), Trichuris vulpis (4) 272 mcg ivermectin, 228 mg (whipworm), and Dipylidium caninum pyrantel pamoate, and 228 mg (tapeworm), and for the prevention of praziquantel. heartworm disease caused by Dirofilaria (b) Sponsor. See No. 051311 in immitis in adult dogs. § 510.600(c) of this chapter. (3) Limitations. Federal law restricts (c) Conditions of use in dogs—(1) this drug to use by or on the order of a Amount. Administer monthly according licensed veterinarian. to body weight as follows: (i) 6 to 12 lb: one tablet as described [73 FR 33692, June 13, 2008, as amended at 74 in paragraph (a)(1) of this section. FR 61516, Nov. 25, 2009] (ii) 12.1 to 25 lb: one tablet as described in paragraph (a)(2) of this sec- § 520.1204 Kanamycin, bismuth subcar- tion. bonate, activated attapulgite. (iii) 25.1 to 50 lb: one tablet as de- (a) Specifications—(1) Each 5 milli- scribed in paragraph (a)(3) of this sec- liters (mL) of suspension contains 100 tion. milligrams (mg) kanamycin (as the (iv) 50.1 to 100 lb: one tablet as de- sulfate), 250 mg bismuth subcarbonate, scribed in paragraph (a)(4) of this sec- and 500 mg activated attapulgite (alu- tion. minum magnesium silicate). (v) Greater than 100 lb: use the appro- (2) Each tablet contains 100 mg priate combination of tablets. kanamycin (as the sulfate), 250 mg bis- (2) Indications for use. To prevent ca- muth subcarbonate, and 500 mg acti- nine heartworm disease by eliminating vated attapulgite. the tissue stage of heartworm larvae (b) Sponsor. See No. 054771 in (Dirofilaria immitis) for 1 month (30 § 510.600(c) of this chapter. days) after infection and for the treat- (c) Conditions of use in dogs—(1) ment and control of roundworm Amount. 5 mL of suspension or 1 tablet (Toxocara canis, Toxascaris leonina), per 20 pounds body weight every 8

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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, organisms susceptible to kanamycin Trichostrongylus, Ostertagia); intestinal and the symptomatic relief of the asso- worms (Trichostrongylus, Cooperia, ciated diarrhea. Nematodirus, Bunostomum, (3) Limitations. Federal law restricts Oesophagostomum); and lungworms this drug to use by or on the order of a (Dictyocaulus). licensed veterinarian. (B) Effective against the following [40 FR 13838, Mar. 27, 1975, as amended at 53 adult nematode infections: Stomach FR 27851, July 25, 1988; 56 FR 8710, Mar. 1, worms (Haemonchus placei, Ostertagia 1991; 64 FR 403, Jan. 5, 1999; 71 FR 43968, Aug. ostertagi, Trichostrongylus axei); intes- 3, 2006; 78 FR 28822, May 20, 2014] tinal worms (T. longispicularis, Cooperia oncophora, C. punctata, Nematodirus § 520.1242 Levamisole. spathiger, Bunostomum phlebotomum, § 520.1242a Levamisole powder. Oesophagostomum radiatum); and lungworms (Dictyocaulus viviparus). (a) Specifications. Each package of powder contains 9.075, 11.7, 18.15, 46.8, (iii) Limitations. Do not slaughter for 362.7, or 544.5 grams (g) levamisole hy- food within 48 hours of treatment. Not drochloride. for use in dairy animals of breeding (b) Sponsors. See sponsors in age. Conditions of constant helminth § 510.600(c) for use as follows: exposure may require retreatment 2 to (1) No. 000061 for use of 46.8- and 544.5- 4 weeks after the first treatment. Con- g packages as in paragraph (e)(1)(i), sult your veterinarian before using in (e)(1)(ii)(B), and (e)(1)(iii) of this sec- severely debilitated animals. tion; for 11.7-, 46.8-, and 544.5-g pack- (2) Sheep—(i) Amount. 8 mg/kg body ages as in paragraph (e)(2)(i), weight as a drench. (e)(2)(ii)(B), and (e)(2)(iii) of this sec- (ii) Indications for use—(A) Effective tion; and for an 18.15-g package as in against the following nematode infec- paragraph (e)(3) of this section. tions: Stomach worms (Haemonchus, (2) No. 054771 for use of a 46.8-g pack- Trichostrongylus, Ostertagia); intestinal age as in paragraph (e)(1)(i), worms (Trichostrongylus, Cooperia, (e)(1)(ii)(A), and (e)(1)(iii) of this sec- Nematodirus, Bunostomum, tion; for 11.7- and 46.8-g packages as in Oesophagostomum, Chabertia); and paragraph (e)(2)(i), (e)(2)(ii)(A), and lungworms (Dictyocaulus). (e)(2)(iii) of this section; and for 9.075- (B) Effective against the following and 18.15-g packages as in paragraph adult nematode infections: Stomach (e)(3) of this section. worms (Haemonchus contortus, (3) No. 016592 for use of 46.8- and 544.5- Trichostrongylus axei, Teladorsagia g packages as in paragraphs (e)(1)(i), circumcincta); intestinal worms (e)(1)(ii)(A), and (e)(1)(iii) and (e)(2)(i), (Trichostrongylus colubriformis, Cooperia (e)(2)(ii)(A), and (e)(2)(iii) of this sec- curticei, Nematodirus spathiger, tion. Bunostomum trigonocephalum, (4) No. 061133 for use of 46.8-, 362.7-, Oesophagostomum columbianum, and 544.5-g packages as in paragraphs Chabertia ovina), and lungworms (e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i), (Dictyocaulus filaria). (e)(2)(ii)(B), and (e)(2)(iii) of this sec- (iii) Limitations. Do not slaughter for tion; and for use of an 18.15-g package food within 72 hours of treatment. Con- as in paragraph (e)(3) of this section. ditions of constant helminth exposure (c) Related tolerances. See § 556.350 of may require retreatment 2 to 4 weeks this chapter. after the first treatment. Consult vet- (d) Special considerations. See § 500.25 erinarian before using in severely de- of this chapter. bilitated animals.

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(3) Swine—(i) Amount. 8 mg/kg body ing age. Consult veterinarian before weight in drinking water. using in severely debilitated animals. (ii) Indications for use. Effective (2) Sheep—(i) Amount. Administer against the following nematode infec- orally one 0.184-gram oblet for each 50 tions: Large roundworms (Ascaris pounds of body weight. suum), nodular worms (ii) Indications for use. Anthelmintic (Oesophagostomum spp.), intestinal effective against the following nema- thread worms (Strongyloides ransomi) tode infections: Stomach worms and lungworms (Metastrongylus spp. ). (Haemonchus, Trichostrongylus, (iii) Limitations. Do not administer Ostertagia), intestinal worms within 72 hours of slaughter for food. (Trichostrongylus, Cooperia, Pigs maintained under conditions of Nematodirus, Bunostomum, constant exposure to worms may re- Oesophagostomum, Chabertia), and quire retreatment within 4 to 5 weeks lungworms (Dictyocaulus). after the first treatment. Consult your (iii) Conditions of con- veterinarian before administering to Limitations. sick swine. stant helminth exposure may require re-treatment within 2 to 4 weeks after [69 FR 9753, Mar. 2, 2004, as amended at 69 FR the first treatment. Do not slaughter 33839, June 17, 2004; 70 FR 2353, Jan. 13, 2005; for food within 72 hours of treatment. 77 FR 28253, May 14, 2012; 78 FR 28822, May 20, Consult a veterinarian before using in 2014; 83 FR 48945, Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019] severely debilitated animals. [78 FR 28822, May 20, 2014] § 520.1242b Levamisol boluses or oblets. § 520.1242c Levamisol and piperazine. (a) Specifications. Each bolus contains (a) Specifications. (1) Each ounce of 2.19 grams levamisol hydrochloride. solution contains 0.36 gram of Each oblet contains 0.184 grams levamisole hydrochloride and piper- levamisol hydrochloride. azine dihydrochloride equivalent to 3.98 (b) Sponsors. See Nos. 000061 and grams of piperazine base. 054771 in § 510.600(c) of this chapter. (2) A soluble powder which when con- (c) Required labeling. Consult your stituted with water contains in each veterinarian for assistance in the diag- fluid ounce 0.45 gram of levamisole hy- nosis, treatment, and control of parasitism. drochloride and piperazine dihydrochloride equivalent to 5.0 grams (d) Related tolerances. See § 556.350 of this chapter. of piperazine base. (e) Conditions of use—(1) Cattle—(i) (b) Sponsor. See No. 054771 in Amount. Administer orally 2.19-gram § 510.600(c) of this chapter. boluses as a single dose as follows: 250 (c) Conditions of use in horses—(1) to 450 pounds, 1⁄2 bolus; 450 to 750 Amount. Aqueous solution: administer pounds, 1 bolus; and 750 to 1,050 pounds, by stomach tube or drench 1 fluid 11⁄2 boluses. ounce per 100 pounds of body weight. (ii) Indications for use. Anthelmintic Reconstituted soluble powder: admin- effective against the following nema- ister by stomach tube 1 fluid ounce per tode infections: Stomach worms 125 pounds of body weight. If reinfec- (Haemonchus, Trichostrongylus, tion occurs, re-treat animals at 6- to 8- Ostertagia), intestinal worms week intervals. (Trichostrongylus, Cooperia, (2) Indications for use. An anthel- Nematodirus, Bunostomum, mintic effective against infections of Oesophagostomum), and lungworms large strongyles (Strongylus vulgaris, S. (Dictyocaulus). edentatus), small strongyles (iii) Limitations. Conditions of con- (Cylicocercus spp., Cylicocyclus spp., stant helminth exposure may require Cylicodontophorus spp., Cylicostephanus re-treatment within 2 to 4 weeks after spp., Cylicotetrapedon spp.), ascarids the first treatment. Do not slaughter (Parascaris equorum), and pinworms for food within 48 hours of treatment. (Oxyuris equi). Not for use in dairy animals of breed-

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(3) Limitations. Do not use in horses assistance in the diagnosis, treatment, intended for human consumption. Fed- and control of parasitism. eral law restricts this drug to use by or [43 FR 18171, Apr. 28, 1978, as amended at 45 on the order of a licensed veterinarian. FR 3574, Jan. 18, 1980]

[78 FR 28823, May 20, 2014] § 520.1242e Levamisole hydrochloride effervescent tablets. § 520.1242d Levamisole resinate. (a) Specifications. Each tablet con- (a) Specifications. The drug is tains 907 milligrams of levamisole hy- levamisole adsorbed on a resin, in a drochloride. concentration equivalent to 10 percent (b) Sponsor. See No. 054771 in levamisole hydrochloride. Each 2.05- § 510.600(c) of this chapter. ounce (58.1 gram) packet contains (c) Related tolerances. See § 556.350 of levamisole equivalent to 5.806 grams of this chapter. levamisole hydrochloride. (d) Conditions of use. It is used for (b) Sponsor. See No. 043781 in swine as follows: § 510.600(c) of this chapter. (1) Amount. The equivalent of 8 milli- (c) Related tolerances. See § 556.350 of grams of levamisole hydrochloride per this chapter. kilogram of body weight, as a single dose. (d) Conditions of use. In swine it is (2) Indications for use. See used as follows: § 520.1242a(f)(3)(ii). (1) Amount. The equivalent of 8 milli- (3) Limitations. Withholding water grams per kilogram of body weight, as from pigs before treatment is not nec- a single dose, mixed in the animal’s ra- essary. Add one tablet for each 21⁄2 gal- tion. lons of water; mix thoroughly. Allow 1 (2) Indications for use. For the re- gallon of medicated water for each 100 moval of and control of the following pounds body weight of pigs to be treat- nematode infections: large roundworms ed. No other source of water should be (Ascaris suum), nodular worms offered. After pigs have consumed (Oesophagostomum spp.), lungworms medicated water, resume use of regular (Metastrongylus spp.), intestinal water. Pigs maintained under condi- threadworms (Strongyloides ransomi), tions of constant worm exposure may and swine kidney worms (Stephanurus require re-treatment within 4 to 5 dentatum). weeks. Consult your veterinarian be- (3) Limitations. For pigs from weaning fore administering to sick swine. Con- sult your veterinarian for assistance in to market weight, mix one 58.1-gram the diagnosis, treatment, and control packet of levamisole resinate con- of parasitism. Do not administer with- taining the equivalent of 10-percent in 72 hours of slaughter for food. levamisole hydrochloride in 40 pounds of feed and administer 1 pound of medi- [45 FR 6087, Jan. 25, 1980, as amended at 67 cated feed per 40 pounds of body weight FR 63055, Oct. 10, 2002; 78 FR 28823, May 20, as sole ration. For breeding swine, mix 2014] 1 packet of the 10-percent resinate in 16 § 520.1242f Levamisol gel. pounds of feed and administer 1 pound (a) Specifications. Each gram of gel of medicated feed per 100 pounds of contains 115 milligrams (11.5 percent) body weight as sole ration. Administer levamisol hydrochloride. as single doses. Withhold regular feed (b) Sponsor. See No. 054771 in overnight and administer medicated § 510.600(c) of this chapter. feed the following morning. Do not (c) Related tolerances. See § 556.350 of withhold water during fasting. Do not this chapter. treat within 72 hours of slaughter. Sali- (d) Conditions of use—(1) Cattle—(i) vation or muzzle foam may be ob- Amount. Eight milligrams of served. The reaction will disappear a levamisole hydrochloride per kilogram short time after feeding. If pigs are in- of body weight, as a single oral dose. fected with mature lungworms, (ii) Indications for use. Anthelmintic coughing and vomiting may be ob- effective against the following nema- served. Consult your veterinarian for tode infections: Stomach worms

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(Haemonchus, Trichostrongylus, grams of famphur activity per kilo- Ostertagia), intestinal worms gram of body weight. (Trichostrongylus, Cooperia, (2) Indications for use. For treatment Nematodirus, Bunostomum, of cattle infected with the following Oesophagostomum), and lungworms parasites: Stomach worms (Dictyocaulus). (Haemonchus, Trichostrongylus, (iii) Limitations. Conditions of con- Ostertagia), intestinal worms stant helminth exposure may require (Trichostrongylus, Cooperia, re-treatment within 2 to 4 weeks after Nematodirus, Bunostomum, the first treatment; do not administer Oesophagostomum), lungworms to cattle within 6 days of slaughter for (Dictyocaulus), cattle grubs food; do not administer to dairy ani- (Hypoderma), biting lice (Bovicola), and mals of breeding age; consult veteri- sucking lice (Linognathus, Solenoptes). narian before using in severely debili- (3) Limitations. Drug is not effective tated animals. against lice eggs. Conditions of con- (2) Breeding swine—(i) Amount. Eight stant helminth and ectoparasitic expo- milligrams per kilogram of body sure may require retreatment within 2 weight (3.6 milligrams per pound) as a to 4 weeks after first treatment. Do not single oral dose. administer to cattle within 19 days of (ii) Conditions of use. For treating slaughter. Do not administer to dairy breeding swine infected with the fol- animals of breeding age. Do not use in lowing nematodes: Large roundworms calves less than 3 months old, or in de- (Ascaris suum), nodular worms bilitated animals. Do not treat Brah- (Oesophagostomum spp.), lungworms man bulls. Consult your veterinarian (Metastrongylus spp.), intestinal for assistance in the diagnosis, treat- threadworms (Strongyloides ransomi), ment, and control of parasitism. and kidney worms (Stephanurus [53 FR 23757, June 24, 1988, as amended at 54 dentatus). FR 1353, Jan. 13, 1989; 57 FR 7652, Mar. 4, 1992; (iii) Limitations. May require retreat- 62 FR 55160, Oct. 23, 1997; 62 FR 61625, Nov. 19, ment in 4 to 5 weeks. Do not use within 1997; 78 FR 28823, May 20, 2014] 11 days of slaughter for food. Consult your veterinarian for assistance before § 520.1248 Levothyroxine. using in severely debilitated animals (a) Specifications. Each tablet con- and in the diagnosis, treatment, and tains 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, or control of parasitism. 1.0 milligrams (mg) levothyroxine sodium. [47 FR 22517, May 25, 1982; 47 FR 30242, July 13, 1982, as amended at 48 FR 11429, Mar. 18, (b) Sponsor. See No. 061690 in 1983; 51 FR 29215, Aug. 15, 1986; 67 FR 63055, § 510.600(c) of this chapter. Oct. 10, 2002; 78 FR 28823, May 20, 2014] (c) Conditions of use—(1) Amount. Ad- minister by mouth 0.1 mg/10 pounds of § 520.1242g Levamisole resinate and body weight (0.022 mg/kilogram) as a famphur paste. single dose every 24 hours or as a di- (a) Specifications. The drug is a paste vided dose every 12 hours. containing 11.6 percent levamisole res- (2) Indications for use. For replace- inate (50 percent potency) and 23.6 per- ment therapy for diminished thyroid cent famphur. function in dogs. (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) Special considerations. Do not use licensed veterinarian. any cholinesterase-inhibiting drugs, [81 FR 22523, Apr. 18, 2016] pesticides, insecticides, or chemicals on cattle simultaneously or within a § 520.1263 Lincomycin. few days before or after treatment with this product. § 520.1263a Lincomycin tablets and (d) Related tolerances. See §§ 556.273 syrup. and 556.350 of this chapter. (a) Specifications. (1) Each ounce of (e) Conditions of use in cattle—(1) syrup contains lincomycin hydro- Amount. 8 milligrams of levamisole hy- chloride equivalent to either 25 or 50 drochloride (equivalent) and 30 milli- milligrams (mg) lincomycin.

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(2) Each tablet contains lincomycin (ii) Indications for use. For the control hydrochloride equivalent to either 25 of necrotic enteritis caused by Clos- or 50 mg lincomycin. tridium perfringens susceptible to linco- (b) Sponsor. See No. 054771 in mycin in broiler chickens. § 510.600(c) of this chapter. (iii) Limitations. Discard medicated (c) Conditions of use in dogs and cats— drinking water if not used within 2 (1) Amount. Administer orally 10 mg per days. Prepare fresh stock solution pound of body weight every 12 hours, or daily. Administer for 7 consecutive 7 mg per pound of body weight every 8 days. Do not allow rabbits, hamsters, hours, for up to 12 days. guinea pigs, horses, or ruminants ac- (2) Indications for use. For infections cess to water containing lincomycin. caused by gram-positive organisms Not for use in layer and breeder chick- which are sensitive to its action, par- ens. Federal law restricts this drug to ticularly streptococci and use by or on the order of a licensed vet- staphylococci. erinarian. (3) Limitations. Federal law restricts (3) Honey bees—(i) Amount. Mix 100 this drug to use by or on the order of a milligrams lincomycin with 20 grams licensed veterinarian. confectioners’/powdered sugar and dust over the top bars of the brood chamber [78 FR 28823, May 20, 2014] once weekly for 3 weeks. (ii) Indications for use. For the control § 520.1263b 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 as follows: contamination of production honey. (1) No. 054771 for use as in paragraph Complete treatments at least 4 weeks (d) of this section. before main honey flow. Federal law re- (2) Nos. 016592, 054925, 061133, and stricts this drug to use by or on the 076475 for use as in paragraphs (d)(1) order of a licensed veterinarian. and (d)(2) of this section. [48 FR 3966, Jan. 28, 1983, as amended at 55 (c) Tolerances. See § 556.360 of this FR 3209, Jan. 31, 1990; 60 FR 14217, Mar. 16, chapter. 1995; 62 FR 65020, Dec. 10, 1997; 64 FR 13341, (d) Conditions of use—(1) Swine—(i) Mar. 18, 1999; 64 FR 13508, Mar. 19, 1999; 64 FR Amount. 250 milligrams per gallon of 66382, Nov. 26, 1999; 65 FR 10705, Feb. 29, 2000; drinking water to provide 3.8 milli- 67 FR 17284, Apr. 10, 2002; 67 FR 71819, Dec. 3, grams per pound of body weight per 2002; 67 FR 78356, Dec. 24, 2002; 68 FR 3817, day. Jan. 27, 2003; 70 FR 1818, Jan. 11, 2005; 77 FR (ii) Indications for use. For the treat- 20988, Apr. 9, 2012; 77 FR 29217, May 17, 2012; 78 FR 28823, May 20, 2014; 81 FR 22523, Apr. 18, ment of swine dysentery (bloody 2016; 81 FR 94989, Dec. 27, 2016; 83 FR 48945, scours). Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019. Redes- (iii) Limitations. Discard medicated ignated at 85 FR 18119, Apr. 1, 2020] drinking water if not used within 2 days. Prepare fresh stock solution § 520.1265 Lincomycin and daily. Do not use for more than 10 days. spectinomycin powder. If clinical signs of disease have not im- (a) Specifications. The following salts proved within 6 days, discontinue of lincomycin and spectinomycin are treatment and reevaluate diagnosis. present in a soluble powder in the ratio The safety of lincomycin has not been of 1 to 2 on the basis of equivalency of demonstrated in pregnant swine or lincomycin base to equivalency of swine intended for breeding. For No. spectinomycin base: 054925: Do not slaughter swine for 6 (1) Lincomycin hydrochloride days following last treatment. Federal monohydrate and spectinomycin sul- law restricts this drug to use by or on fate tetrahydrate. the order of a licensed veterinarian. (2) Lincomycin hydrochloride (2) Chickens—(i) Amount. 64 milli- monohydrate and spectinomycin grams per gallon of drinking water. dihydrochloride pentahydrate.

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(b) Sponsors. See sponsors in § 520.1286 Lotilaner. § 510.600(c) of this chapter for use as in (a) Specifications. Each chewable tab- paragraph (d) of this section. let contains: (1) No. 054771 for use of product de- (1) For use in dogs: 56.25, 112.5, 225, scribed in paragraph (a)(1) of this sec- 450, or 900 milligrams (mg) lotilaner; or tion. (2) For use in cats: 12 or 48 mg (2) Nos. 016592, 061133, and 066104 for lotilaner. use of product described in paragraph (b) Sponsor. See No. 058198 in (a)(2) of this section. § 510.600(c) of this chapter. (c) Tolerances. See §§ 556.360 and (c) Conditions of use—(1) Dogs—(i) 556.600 of this chapter. Amount. Administer orally once a (d) Conditions of use in chickens—(1) month at the recommended minimum Amount. 2 grams of antibiotic activity dosage of 9 mg/lb (20 mg/kg). per gallon of drinking water; admin- (ii) Indications for use. Kills adult ister as the sole source of water for the fleas, and for the treatment and pre- first 5 to 7 days of life. vention of flea infestations (2) Indications for use. As an aid in the (Ctenocephalides felis), and the treat- control of airsacculitis caused by ei- ment and control of tick infestations ther Mycoplasma synoviae or M. (Amblyomma americanum (lone star gallisepticum susceptible to lincomycin- tick), Dermacentor variabilis (American spectinomycin and complicated chron- dog tick), Ixodes scapularis (black- ic respiratory disease (air sac infec- legged tick), and Rhipicephalus tion) caused by Escherichia coli and M. sanguineus (brown dog tick)) for 1 gallisepticum susceptible to lincomycin- month in dogs and puppies 8 weeks of spectinomycin. age or older and weighing 4.4 pounds or (3) Limitations. Federal law restricts greater. this drug to use by or on the order of a (iii) Limitations. Federal law restricts licensed veterinarian. this drug to use by or on the order of a [69 FR 13220, Mar. 22, 2004, as amended at 70 licensed veterinarian. FR 40881, July 15, 2005; 71 FR 71038, Dec. 8, (2) Cats—(i) Amount. Administer oral- 2006; 77 FR 56770, Sept. 14, 2012; 78 FR 28823, ly once a month at the recommended May 20, 2014; 81 FR 94989, Dec. 27, 2016; 83 FR minimum dosage of 2.7 mg/lb (6 mg/kg). 48945, Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019] (ii) Indications for use. Kills adult fleas, and for the treatment and pre- § 520.1284 Liothyronine. vention of flea infestations (a) Specifications. Each tablet con- (Ctenocephalides felis) for 1 month in tains 60 or 120 micrograms (μg) cats and kittens 8 weeks of age or older liothyronine as the sodium salt. and weighing 2 pounds or greater. (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 in dogs—(1) licensed veterinarian. Amount. Administer orally to dogs at [85 FR 18119, Apr. 1, 2020] levels up to 12.8 μg per kilogram (/kg) of body weight per day. Dosage should § 520.1288 Lufenuron tablets. be adjusted according to the severity of (a) Specifications—(1) Tablets con- the condition and the response of the taining 45, 90, 204.9, or 409.8 milligrams patient. Dosage at the total replace- (mg) lufenuron for use as in paragraphs ment level (12.8 μg/kg of body weight) (c)(1)(i), (c)(1)(ii)(A), (c)(1)(iii), (c)(2)(i), should be considered for initiating (c)(2)(ii)(A), and (c)(2)(iii) of this sec- therapy and then titrated downward tion. for optimum maintenance effect. Twice (2) Flavored tablets containing 45, 90, daily administration is recommended. 204.9, or 409.8 milligrams (mg) (2) Indications for use. For treatment lufenuron for use as in paragraphs of hypothyroidism in dogs. (c)(1)(i), (c)(1)(ii)(A) or (c)(1)(ii)(B), and (3) Limitations. Federal law restricts (c)(1)(iii) of this section. this drug to use by or on the order of a (3) Flavored tablets containing 90 or licensed veterinarian. 204.9 mg lufenuron for use as in para- [78 FR 28823, May 20, 2014] graphs (c)(2)(i), (c)(2)(ii)(A) or

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

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

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

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(3) Limitations. Federal law restricts (2) No. 054771 for use of 1- and 4-mg this drug to use by or on the order of a tablets. licensed veterinarian. (c) Conditions of use in dogs and cats— [68 FR 42968, July 21, 2003, as amended at 69 (1) Amount. 5 to 15 pounds (lbs): 2 mg; 15 FR 69523, Nov. 30, 2004. Redesignated and to 40 lbs: 2 to 4 mg; 40 to 80 lbs: 4 to 8 amended at 78 FR 57058, Sept. 17, 2013; 80 FR mg. Administer total daily dose orally 53459, Sept. 4, 2015] in equally divided doses 6 to 10 hours apart until response is noted or 7 days § 520.1372 Methimazole. have elapsed. (a) Specifications. Each tablet con- (2) Indications for use. As an anti-in- tains 2.5 or 5 milligrams (mg) flammatory agent. methimazole. (3) Limitations. Federal law restricts (b) Sponsor. See No. 043264 in § 510.600 this drug to use by or on the order of a of this chapter. licensed veterinarian. (c) Conditions of use in cats—(1) [78 FR 28824, May 20, 2014, as amended at 83 Amount. The starting dose is 2.5 mg FR 48946, Sept. 28, 2018] every 12 hours. Following 3 weeks of treatment, the dose should be titrated § 520.1409 Methylprednisolone and as- to effect based on individual serum pirin. total T4 levels and clinical response. (a) Specifications. Each tablet con- (2) Indications for use. For the treat- tains 0.5 milligram of ment of hyperthyroidism. methylprednisolone and 300 milligrams (3) Limitations. Federal law restricts of aspirin. this drug to use by or on the order of a (b) Sponsor. See No. 054771 in licensed veterinarian. § 510.600(c) of this chapter. [74 FR 27707, June 11, 2009] (c) Conditions of use in dogs—(1) Amount. Under 15 pounds, 1⁄4 to 1 tablet § 520.1380 Methocarbamol. daily; 15 to 60 pounds, 1 to 2 tablets (a) Specifications. Each tablet con- daily; 60 pounds and over, 2 tablets tains 500 milligrams (mg) of daily. Administer total daily dose in methocarbamol. divided doses 6 to 10 hours apart, with (b) Sponsor. See No. 054771 in a light feeding. When response is at- § 510.600(c) of this chapter. tained, dosage should be gradually re- (c) Conditions of use in dogs and cats— duced until maintenance level is (1) Amount. Administer 60 mg per pound achieved. of body weight in two or three equally (2) Indications for use. As an anti-in- divided doses, followed each following flammatory and analgesic agent. day by 30 to 60 mg per pound of body (3) Limitations. Federal law restricts weight, usually not to exceed 14 to 21 this drug to use by or on the order of a days. licensed veterinarian. (2) Indications for use. As an adjunct [48 FR 21566, May 13, 1983, as amended at 78 to therapy for acute inflammatory and FR 28824, May 20, 2014] traumatic conditions of the skeletal muscles in order to reduce muscular § 520.1422 Metoserpate hydrochloride. spasms. (a) Chemical name. Methyl-o-methyl- (3) Limitations. Federal law restricts 18-epireserpate hydrochloride. this drug to use by or on the order of a (b) Sponsor. See No. 054771 in licensed veterinarian. § 510.600(c) of this chapter. [78 FR 28824, May 20, 2014] (c) Related tolerances. See § 556.410 of this chapter. § 520.1408 Methylprednisolone. (d) Conditions of use. It is used in (a) Specifications. Each tablet con- drinking water for replacement chick- tains 1, 2, or 4 milligrams (mg) of ens as follows: methylprednisolone. (1) Amount. 568.5 milligrams per gal- (b) Sponsors. See sponsors in lon (0.015 percent). § 510.600(c) of this chapter. (i) Indications for use. As a tranquil- (1) No. 069043 for use of 1- and 2-mg izer for flock treatment of chickens tablets. prior to handling.

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(ii) Limitations. To be used one time § 520.1441 Milbemycin. as a treatment for replacement chick- (a) Specifications. Each flavored tablet ens up to 16 weeks of age; usual drink- contains 2.3, 5.75, 11.5, or 23.0 milli- ing water should be withheld prior to grams (mg) of milbemycin oxime. treatment to provide adequate con- (b) Sponsors. See Nos. 013744 and sumption of medicated drinking water; 058198 in § 510.600(c) of this chapter. not for use in laying chickens; chickens slaughtered within 72 hours fol- (c) Conditions of use—(1) Dogs—(i) lowing treatment must not be used for Amount. For hookworm, roundworm, food. and whipworm, administer 0.23 mg per (2) Amount. 2 to 4 milligrams per 2.2 pound (mg/lb) of body weight (0.5 mg pounds of body weight. per kilogram (mg/kg)). For heartworm, (i) Indications for use. As an aid in administer 0.05 mg/lb of body weight control of hysteria. (0.1 mg/kg). Administer once a month. (ii) Limitations. To be used as a treat- (ii) Indications for use. For prevention ment for replacement chickens up to 16 of heartworm disease caused by weeks of age; usual drinking water Dirofilaria immitis, control of hookworm should be withheld prior to treatment infections caused by Ancylostoma to provide adequate consumption of caninum, and removal and control of medicated drinking water; the drug adult roundworm infections caused by should be administered at a dosage Toxocara canis and Toxascaris leonina level of 4 milligrams per 2.2 pounds of and whipworm infections caused by body weight followed by 2 treatments Trichuris vulpis in dogs and puppies 4 at 4-day intervals of 2 milligrams per weeks of age or greater and 2 pounds 2.2 pounds of body weight; not for use body weight or greater. in laying chickens; chickens slaugh- (iii) Limitations. Federal law restricts tered within 72 hours following treat- this drug to use by or on the order of a ment must not be used for food. licensed veterinarian. (2) Cats—(i) Amount. Administer 0.91 [40 FR 13838, Mar. 27, 1975, as amended at 76 mg/lb of body weight (2.0 mg/kg) once a FR 17337, Mar. 29, 2011; 78 FR 28824, May 20, 2014] month. (ii) Indications for use. For prevention § 520.1430 Mibolerone. of heartworm disease caused by (a) Specifications. Each milliliter con- Dirofilaria immitis and the removal of tains 100 micrograms of mibolerone. adult Toxocara cati (roundworm) and (b) Sponsor. See No. 054771 in Ancylostoma tubaeforme (hookworm) in- § 510.600(c) of this chapter. fections in cats 6 weeks of age or great- (c) Conditions of use in dogs—(1) er and 1.5 pounds body weight or great- Amount. 30 micrograms for animals er. weighing 1 to 25 pounds; 60 micrograms (iii) Limitations. Federal law restricts for animals weighing 26 to 50 pounds; this drug to use by or on the order of a 120 micrograms for animals weighing 51 licensed veterinarian. to 100 pounds; 180 micrograms for ani- [84 FR 12494, Apr. 2, 2019] mals weighing over 100 pounds, German Shepherds, or German Shepherd mix. § 520.1443 Milbemycin oxime and Administer daily, orally or in a small lufenuron. amount of food, at least 30 days before (a) Specifications—(1) Tablets con- expected initiation of heat, and containing: 2.3 milligrams (mg) tinue daily as long as desired, but not milbemycin oxime and 46 mg for more than 24 months. lufenuron, 5.75 mg milbemycin oxime (2) Indications for use. For the preven- and 115 mg lufenuron, 11.5 mg tion of estrus (heat) in adult female milbemycin oxime and 230 mg dogs not intended primarily for breed- lufenuron, or 23 mg milbemycin oxime ing purposes. and 460 mg lufenuron. (3) Limitations. Federal law restricts (2) Flavored tablets containing: 2.3 this drug to use by or on the order of a mg milbemycin oxime and 46 mg licensed veterinarian. lufenuron, 5.75 mg milbemycin oxime [43 FR 15625, Apr. 14, 1978, as amended at 78 and 115 mg lufenuron, 11.5 mg FR 28824, May 20, 2014] milbemycin oxime and 230 mg

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

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(2) [Reserved] (c) Related tolerances. See § 556.425 of this chapter. [77 FR 4225, Jan. 27, 2012, as amended at 80 (d) Conditions of use—(1) Amount. FR 18776, Apr. 8, 2015; 83 FR 13635, Mar. 30, 2018] Grazing cattle: Administer 1 cartridge to each animal at the start of the graz- § 520.1450 Morantel tartrate oral dosing season. age forms. (2) Indications for use. For control of the adult stage of the following gastro- § 520.1450a Morantel tartrate bolus. intestinal nematode infections in (a) Specifications. Each bolus contains weaned calves and yearling cattle 2.2 grams morantel tartrate equivalent weighing a minimum of 200 pounds: to 1.3 grams of morantel base. Ostertagia spp., Trichostrongylus axei, (b) Sponsor. See No. 054771 in Cooperia spp., and Oesophagostomum § 510.600(c) of this chapter. radiatum. (c) Related tolerances. See § 556.425 of (3) Limitations. Administer orally this chapter. with the dosing gun to all cattle that will be grazing the same pasture. Effec- (d) Conditions of use—(1) Amount. One tiveness of the drug product is depend- bolus per 500 pounds of body weight (4.4 ent upon continuous control of the gas- milligrams per pound of body weight) trointestinal parasites for approxi- as a single oral dose. Boluses may be mately 90 days following administra- divided in half for more accurate dos- tion. Therefore, treated cattle should ing as follows: up to 325 pounds, 1⁄2 not be moved to pastures grazed in the bolus; 326 to 600 pounds, 1 bolus; 601 to same grazing season/calendar year by 900 pounds, 11⁄2 boluses; and 901 to 1,200 untreated cattle. Do not administer to pounds, 2 boluses. cattle within 106 days of slaughter. (2) Indications for use. For removal Consult your veterinarian before ad- and control of mature gastrointestinal ministering to severely debilitated ani- nematode infections of cattle including mals and for assistance in the diag- stomach worms (Haemonchus spp., nosis, treatment, and control of para- Ostertagia spp., Trichostrongylus spp.), sitism. worms of the small intestine (Cooperia spp., Trichostrongylus spp., Nematodirus [49 FR 47831, Dec. 7, 1984, as amended at 51 spp.), and worms of the large intestine FR 23415, June 27, 1986; 51 FR 41081, Nov. 13, (Oesophagostomum radiatum). 1986; 78 FR 28825, May 20, 2014] (3) Limitations. Conditions of constant § 520.1450c Morantel tartrate sus- worm exposure may require retreat- tained-release trilaminate cylinder/ ment in 2 to 4 weeks. Consult your vet- sheet. erinarian before administering to se- (a) Specifications. The drug product verely debilitated animals and for as- consists of a trilaminated, perforated, sistance in the diagnosis, treatment, plastic sheet formed into a cylinder and control of parasitism. Do not treat having plastic plugs in its ends. The within 14 days of slaughter. core lamina contains 19.8 grams of [46 FR 50949, Oct. 16, 1981. Redesignated at 49 morantel tartrate equivalent to 11.8 FR 47831, Dec. 7, 1984, and amended at 51 FR grams of morantel base. 9005, Mar. 17, 1986; 78 FR 28825, May 20, 2014] (b) Sponsor. See 054771 in § 510.600(c) of this chapter. § 520.1450b Morantel tartrate car- (c) Related tolerances. See § 556.425 of tridge. this chapter. (a) Specifications. The drug product (d) Conditions of use—(1) Amount. consists of a stainless-steel cylinder Grazing cattle: Administer 1 cartridge having both ends closed with poly- to each animal at the start of the graz- ethylene diffusing discs and containing ing season. a morantel tartrate paste. The paste (2) Indications for use. For control of contains 22.7 grams of morantel tar- the adult stage of the following gastro- trate equivalent to 13.5 grams of intestinal nematode infections in morantel base. weaned calves and yearling cattle (b) Sponsor. See No. 054771 in weighing a minimum of 200 pounds: § 510.600(c) of this chapter. Ostertagia spp., Trichostrongylus axei,

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Cooperia spp., and Oesophagostomum tissue stages), Triodontophorus radiatum. brevicauda (adults), and T. serratus (3) Limitations. Administer orally (adults); small strongyles (adults): with the dosing gun to all cattle that Cyathostomum spp., including C. will be grazing the same pasture. Effec- catinatum and C. pateratum; tiveness of the drug product is depend- Cylicocyclus. spp., including C. insigne, ent upon continuous control of the gas- C. leptostomum, C. nassatus, and C. trointestinal parasites for approxi- radiatus; Cyliocostephanus spp., includ- mately 90 days following administra- ing C. calicatus, C. goldi, C. tion. Therefore, treated cattle should longibursatus, and C. minutus; not be moved to pastures grazed in the Coronocyclus spp., including C. same grazing season/calendar year by coronatus, C. labiatus, and C. labratus; untreated cattle. Do not administer to Gyalocephalus capitatus; and cattle within 102 days of slaughter. Petrovinema poculatus; small Consult your veterinarian before ad- strongyles: undifferentiated lumenal ministering to severely debilitated ani- larvae; encysted cyathostomes (late L3 mals and for assistance in the diag- and L4 mucosal cyathostome larvae); nosis, treatment, and control of para- ascarids: Parascaris equorum (adults and sitism. L4 larval stages); pinworms: Oxyuris equi (adults and L4 larval stages); [56 FR 13396, Apr. 2, 1991, as amended at 78 FR 28825, May 20, 2014] hairworms: Trichostrongylus axei (adults); large-mouth stomach worms: § 520.1451 Moxidectin tablets. Habronema muscae (adults); and horse stomach bots: Gasterophilus intestinalis (a) Specifications. Each tablet con- (2nd and 3rd instars) and G. nasalis (3rd tains 30, 68, or 136 micrograms of instars). One dose also suppresses moxidectin. strongyle egg production for 84 days. (b) Sponsor. See No. 054771 in (3) Limitations. Do not use in horses § 510.600(c) of this chapter. intended for human consumption. (c) Conditions of use—(1) Amount. 3 micrograms per kilogram (1.36 [62 FR 42902, Aug. 11, 1997, as amended at 64 micrograms per pound) of body weight. FR 66105, Nov. 24, 1999; 68 FR 51445, Aug. 27, (2) Indications for use. To prevent in- 2003; 69 FR 24959, May 5, 2004; 70 FR 75017, fection by the canine heartworm Dec. 19, 2005; 78 FR 28825, May 20, 2014] Dirofilaria immitis and the subsequent § 520.1453 Moxidectin and development of canine heartworm dis- praziquantel gel. ease. (a) Specifications. Each milliliter of (3) Limitations. Federal law restricts gel contains 20 milligrams (mg) (2.0 this drug to use by or on the order of a percent) moxidectin and 125 mg (12.5 licensed veterinarian. percent) praziquantel. [62 FR 37713, July 15, 1997, as amended at 78 (b) Sponsor. See No. 054771 in FR 28825, May 20, 2014] § 510.600(c) of this chapter. (c) Special considerations. See § 500.25 § 520.1452 Moxidectin gel. of this chapter. (a) Specifications. Each milliliter of (d) Conditions of use in horses and gel contains 20 milligrams (2 percent) ponies—(1) Amount. Administer by moxidectin. mouth as a single dose: 0.4 mg (b) Sponsor. See No. 054771 in moxidectin per kilogram and 2.5 mg § 510.600(c) of this chapter. praziquantel per kilogram (2.2 pounds) (c) Special considerations. See § 500.25 body weight. of this chapter. (2) Indications for use. For the treat- (d) Conditions of use in horses and ment and control of large strongyles: ponies—(1) Amount. 0.4 milligram Strongylus vulgaris (adults and L4/L5 ar- moxidectin per kilogram (2.2 pounds) of terial stages), S. edentatus (adult and body weight. tissue stages), Triodontophorus (2) Indications for use. For the treat- brevicauda (adults), and T. serratus ment and control of large strongyles: (adults); small strongyles (adults): Strongylus vulgaris (adults and L4/L5 ar- (Cyathostomum spp., including C. terial stages), S. edentatus (adult and catinatum and C. pateratum; Cylicocyclus

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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; 82 FR 21690, May 10, and C. minutus; Coronocyclus spp., in- 2017] cluding C. coronatus, C. labiatus, and C. labratus; Gyalocephalus capitatus; and § 520.1468 Naproxen. Petrovinema poculatus; small (a) Specifications. Each gram of gran- strongyles: undifferentiated lumenal ules contains 500 milligrams (mg) (50 larvae; encysted cyathostomes (late L3 percent) naproxen. and L4 mucosal cyathostome larvae); (b) Sponsor. See No. 054771 in ascarids: Parascaris equorum (adults and § 510.600(c) of this chapter. L4 larval stages); pinworms: Oxyuris (c) Conditions of use in horses—(1) equi (adults and L4 larval stages); Amount. 10 mg per kilogram of body hairworms: Trichostrongylus axei weight twice daily top dressed on feed (adults); large-mouth stomach worms: for up to 14 consecutive days. Habronema muscae (adults); horse stom- (2) Indications for use. For the relief of ach bots: Gasterophilus intestinalis (2nd inflammation and associated pain and and 3rd instars) and G. nasalis (3rd lameness exhibited with arthritis, as instars); and tapeworms: Anoplocephala well as myositis and other soft tissue perfoliata (adults). One dose also sup- diseases of the musculoskeletal sys- presses strongyle egg production for 84 tem. days. (3) Limitations. Do not use in horses (3) Limitations. Do not use in horses intended for human consumption. Fed- intended for human consumption. eral law restricts this drug to use by or on the order of a licensed veterinarian. [68 FR 51446, Aug. 27, 2003, as amended at 69 FR 21956, Apr. 23, 2004; 70 FR 75017, Dec. 19, [78 FR 28825, May 20, 2014] 2005; 78 FR 28825, May 20, 2014] § 520.1484 Neomycin. § 520.1454 Moxidectin solution. (a) Specifications—(1) Each ounce of (a) Specifications. Each milliliter powder contains 20.3 grams (g) neomy- (mL) of solution contains 1 milligram cin sulfate (equivalent to 14.2 g neomy- (mg) moxidectin. cin base). (b) Sponsor. See No. 000859 in (2) Each milliliter of solution con- § 510.600(c) of this chapter. tains 200 milligrams (mg) neomycin sulfate (equivalent to 140 mg neomycin (c) Related tolerances. See § 556.426 of base). this chapter. (b) Sponsors. See sponsors in (d) See § 500.25 Special considerations. § 510.600(c) of this chapter for use as in of this chapter. paragraph (e) of this section. (e) Conditions of use in sheep—(1) (1) Nos. 054771 and 054925 for use of Amount. Administer 1 mL per 11 pounds product described in paragraph (a)(1) as body weight (1 mL per 5 kilograms) by in paragraph (e)(1) of this section. mouth. (2) Nos. 016592, 054771, 058005, and (2) Indications for use. For the treat- 061133 for use of product described in ment and control of the adult and L4 paragraph (a)(1) as in paragraphs (e)(1) larval stages of Haemonchus contortus, and (e)(2) of this section. Teladorsagia circumcincta, T. trifurcata, (3) Nos. 016592, 054771, 054925, and Trichostrongylus axei, T. colubriformis, T. 058005 for use of product described in vitrinus, Cooperia curticei, C. oncophora, paragraph (a)(2) as in paragraph (e)(1) Oesophagostomum columbianum, O. of this section. venulosum, Nematodirus battus, N. (c) Related tolerances. See § 556.430 of filicollis, and N. spathiger. this chapter. (3) Limitations. Sheep must not be (d) Special labeling considerations. La- slaughtered for human consumption beling shall bear the following warning within 7 days of treatment. Because a statements: ‘‘A withdrawal period has withholding time in milk has not been not been established for use in established for this product, do not use preruminating calves. Do not use in

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calves to be processed for veal. Use of more than 25 lb, as needed, for use as in more than one product containing neo- paragraph (d)(1)(ii)(A) of this section. mycin or failure to follow withdrawal (B) One 11.4-mg tablet for dogs weigh- times may result in illegal drug resi- ing less than 25 lb or one 57 mg tablet dues.’’ for dogs weighing more than 25 lbs, (e) Conditions of use—(1) Cattle, swine, once or twice weekly, for use as in sheep, and goats—(i) Amount. 10 mg per paragraph (d)(1)(ii)(B) of this section. pound (/lb) of body weight per day (22 (ii) Indications for use. (A) For the mg per kilogram (/kg)) in divided doses treatment of flea infestations on dogs for a maximum of 14 days. and puppies 4 weeks of age and older (ii) Indications for use. For the treat- and 2 lbs of body weight or greater. ment and control of colibacillosis (bac- (B) The concurrent use of nitenpyram terial enteritis) caused by Escherichia tablets as in paragraph (d)(1)(i)(B) of coli susceptible to neomycin sulfate. this section with either flavored (iii) Limitations. Discontinue treat- lufenuron tablets as in § 520.1288(c)(1) of ment prior to slaughter as follows: Cat- tle, 1 day; sheep, 2 days; swine and this chapter or flavored milbemycin goats, 3 days. Federal law restricts this and lufenuron tablets as in drug to use by or on the order of a li- § 520.1443(d)(1) is indicated to kill adult censed veterinarian. fleas and prevent flea eggs from hatch- (2) Turkeys—(i) Amount. 10 mg/lb of ing. body weight per day (22 mg/kg) for 5 (2) Cats—(i) Amount—(A) One 11.4-mg days. tablet, as needed, for use as in para- (ii) Indications for use. For the control graph (d)(2)(ii)(A) of this section. of mortality associated with E. coli sus- (B) One 11.4-mg tablet, once or twice ceptible to neomycin sulfate in grow- weekly, for use as in paragraph ing turkeys. (d)(2)(ii)(B) of this section. (iii) Limitations. Federal law restricts (ii) Indications for use—(A) For the this drug to use by or on the order of a treatment of flea infestations on cats licensed veterinarian. and kittens 4 weeks of age and older [71 FR 56866, Sept. 28, 2006, as amended at 71 and 2 lbs of body weight or greater. FR 68738, Nov. 28, 2006; 78 FR 17596, Mar. 22, (B) The concurrent use of nitenpyram 2013; 78 FR 28825, May 20, 2014; 81 FR 22523, tablets as in paragraph (d)(2)(i)(B) of Apr. 18, 2016; 81 FR 94989, Dec. 27, 2016; 84 FR this section with flavored lufenuron 8973, Mar. 13, 2019] tablets as in § 520.1288(c)(2) of this chapter is indicated to kill adult fleas and § 520.1510 Nitenpyram. prevent flea eggs from hatching. (a) Specifications. Each tablet contains 11.4 or 57 milligrams (mg) [68 FR 51906, Aug. 29, 2003, as amended at 80 nitenpyram. FR 18776, Apr. 8, 2015] (b) Sponsors. See sponsor numbers in § 520.1604 Oclacitinib. § 510.600(c) of this chapter: (1) No. 058198 for use as in paragraphs (a) Specifications. Each tablet con- (d)(1)(i)(A), (d)(1)(ii)(A), and (d)(2) of tains 3.6, 5.4, or 16 milligrams (mg) of this section. oclacitinib as oclacitinib maleate. (2) No. 051311 for use as in paragraphs (b) Sponsor. See No. 054771 in (d)(1)(i)(B) and (d)(1)(ii)(B) of this sec- § 510.600(c) of this chapter. tion. (c) Conditions of use—(1) Amount. Ad- (c) Special considerations. The concur- minister orally 0.18 to 0.27 mg/per rent use of nitenpyram tablets and fla- pound of body weight (0.4 to 0.6 mg/kg vored milbemycin/lufenuron tablets as body weight) twice daily for up to 14 in paragraph (d)(1)(ii)(B) of this section days; then administered once daily for shall be by or on the order of a licensed maintenance therapy. veterinarian. (2) Indications for use. For control of (d) Conditions of use—(1) Dogs—(i) pruritus associated with allergic der- Amount—(A) One 11.4-mg tablet for matitis and control of atopic derma- dogs weighing less than 25 pounds (lb) titis in dogs at least 12 months of age. or one 57-mg tablet for dogs weighing

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(3) Limitations. Federal law restricts hibits the extralabel use of this drug in this drug to use by or on the order of a food producing animals. licensed veterinarian. [71 FR 14643, Mar. 23, 2006, as amended at 75 [78 FR 42007, July 15, 2013] FR 26646, May 12, 2010]

§ 520.1615 Omeprazole. § 520.1618 Orbifloxacin suspension. (a) Specifications. Each gram of paste (a) Specifications. Each milliliter of contains 0.37 gram omeprazole. suspension contains 30 milligrams (mg) (b) Sponsor. See No. 000010 in orbifloxacin. § 510.600(c) of this chapter. (b) Sponsor. See No. 000061 in (c) Special considerations. When la- 510.600(c) of this chapter. beled for use as in paragraph (d)(2)(i) of (c) Special considerations. Federal law this section, product labeling shall restricts this drug to use by or on the bear: ‘‘Federal law restricts this drug order of a licensed veterinarian. Fed- to use by or on the order of a licensed eral law prohibits the extralabel use of veterinarian.’’ this drug in food-producing animals. (d) Conditions of use in horses—(1) (d) Conditions of use—(1) Dogs—(i) Amount—(i) For treatment of gastric Amount. 1.1 to 3.4 mg/lb (2.5 to 7.5 mg/ ulcers, 1.8 milligrams per pound (mg/lb) kg) of body weight once daily. of body weight (4 milligrams per kilo- (ii) Indications for use. For the treat- gram (mg/kg)) once daily for 4 weeks. ment of urinary tract infections (cys- For prevention of recurrence of gastric titis) in dogs caused by susceptible ulcers, 0.9 mg/lb of body weight (2 mg/ strains of Staphylococcus kg) once daily for at least an addi- pseudintermedius, Proteus mirabilis, Esch- tional 4 weeks. erichia coli, and Enterococcus faecalis (ii) For prevention of gastric ulcers and skin and soft tissue infections using the premarked syringe, one dose (wounds and abscesses) in dogs caused per day for 8 or 28 days. Each dose de- by susceptible strains of Staphylococcus livers at least 1 mg/kg of body weight. pseudintermedius, Staphylococcus aureus, Horses over 1,200 lb body weight should coagulase-positive staphylococci, receive two doses per day. Pasteurella multocida, Proteus mirabilis, (2) Indications for use. (i) For treat- Pseudomonas spp., Klebsiella ment and prevention of recurrence of pneumoniae, E. coli, Enterobacter spp., gastric ulcers in horses and foals 4 Citrobacter spp., E. faecalis, b-hemolytic weeks of age and older. streptococci (Group G), and Strepto- (ii) For prevention of gastric ulcers coccus equisimilis. in horses. (2) Cats—(i) Amount. 3.4 mg/lb (7.5 mg/ (3) Limitations. Do not use in horses kg) of body weight once daily. intended for human consumption. (ii) Indications for use. For the treat- [69 FR 13220, Mar. 22, 2004, as amended at 71 ment of skin infections (wounds and FR 59374, Oct. 10, 2006; 84 FR 39183, Aug. 9, abscesses) in cats caused by susceptible 2019] strains of S. aureus, E. coli, and P. multocida. § 520.1616 Orbifloxacin tablets. (a) Specifications. Each tablet con- [75 FR 26646, May 12, 2010] tains 5.7, 22.7, or 68 milligrams (mg) orbifloxacin. § 520.1628 Oxfendazole powder and pellets. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (a) Specifications—(1) Powder for sus- (c) Conditions of use in dogs and cats— pension. Each gram of powder contains (1) Amount. 2.5 to 7.5 mg per kilogram 7.57 percent oxfendazole. body weight once daily. (2) Pellets. Each gram of pellets con- (2) Indications for use. For manage- tains 6.49 percent oxfendazole. ment of diseases associated with bac- (b) Sponsor. See No. 054771 in teria susceptible to orbifloxacin. § 510.600(c) of this chapter. (3) Limitations. Federal law restricts (c) Conditions of use—(1) Amount. 10 this drug to use by or on the order of a milligrams per kilogram of body licensed veterinarian. Federal law pro- weight.

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(2) Indications for use. The drug is horses. Not for use in horses intended used in horses for removal of the fol- for food. Consult your veterinarian for lowing gastrointestinal worms: Large assistance in the diagnosis, treatment, roundworms (Parascaris equorum), ma- and control of parasitism. ture and immature pinworms (Oxyuris (b)(1) Specifications. Each gram of equi), large strongyles (Strongylus paste contains 185 milligrams of edentatus, Strongylus vulgaris, and oxfendazole (18.5 percent). Strongylus equinus), and small (2) Sponsor. See No. 054771 in strongyles. § 510.600(c) of this chapter. (3) Limitations—(i) Powder for suspen- (3) Related tolerances. See § 556.495 of sion. For gravity administration via this chapter. stomach tube or for positive adminis- (4) Conditions of use—(i) Amount. 4.5 tration via stomach tube and dose sy- milligrams per kilogram of body ringe. Discard unused portions of sus- weight (2.05 milligrams per pound). pension after 24 hours. Mix drug ac- (ii) Indications for use. The drug is cording to directions prior to use. Ad- used in cattle for the removal and con- minister drug with caution to sick or trol of the following worms: lungworms debilitated horses. Not for use in (Dictyocaulus viviparus—adult, L4); horses intended for food. Federal law stomach worms: barberpole worms restricts this drug to use by or on the (Haemonchus contortus and H. placei— order of a licensed veterinarian. adult), small stomach worms (ii) Pellets. The drug is given by sprin- (Trichostrongylus axei—adult), brown kling on the grain portion of the ra- stomach worms (Ostertagia ostertagi— tion. Withholding feed or water prior adult, L4, inhibited L4); intestinal to administration is not necessary. Ad- worms; nodular worms minister drug with caution to sick or (Oesophagostomum radiatum—adult), debilitated horses. Not for use in hookworms (Bunostomum horses intended for food. Consult your phlebotomum—adult), small intestinal veterinarian for assistance in the diag- worms (Cooperia punctata, C. oncophora, nosis, treatment, and control of para- and C. mcmasteri—adult, L4); and tape- sitism. worms (Moniezia benedeni—adult). [44 FR 35211, June 19, 1979, as amended at 46 (iii) Limitations. For use in cattle FR 26301, May 12, 1981; 46 FR 60570, Dec. 11, only. Treatment may be repeated in 4 1981; 49 FR 28549, July 13, 1984; 61 FR 5506, to 6 weeks. Cattle must not be slaugh- Feb. 13, 1996; 78 FR 28825, May 20, 2014] tered until 11 days after treatment. Do not use in female dairy cattle of breed- § 520.1629 Oxfendazole paste. ing age. Consult a veterinarian for as- (a)(1) Specifications. Each gram of sistance in the diagnosis, treatment, paste contains 0.375 gram oxfendazole and control of parasitism. (37.5 percent). (2) Sponsor. See No. 054771 in [49 FR 38250, Sept. 28, 1984, as amended at 58 § 510.600(c) of this chapter. FR 39443, July 23, 1993; 61 FR 5506, Feb. 13, (3) Conditions of use—(i) Amount. 10 1996; 78 FR 28825, May 20, 2014] milligrams per kilogram (2.2 pounds) of § 520.1630 Oxfendazole suspension. body weight. (ii) Indications for use. The drug is (a) Specifications. Each milliliter of used in horses for removal of the fol- suspension contains: lowing gastrointestinal worms: Large (1) 90.6 milligrams (mg) oxfendazole roundworms (Parascaris equorum), ma- (9.06 percent). ture and 4th stage larvae pinworms (2) 225.0 mg oxfendazole (22.5 percent). (Oxyuris equi), large strongyles (b) Sponsor. See Nos. 000010 and 054771 (Strongylus edentatus, S. vulgaris, and S. in § 510.600(c) of this chapter. equinus), and small strongyles. (c) Related tolerances. See § 556.495 of (iii) Limitations. Horses maintained this chapter. on premises where reinfection is likely (d) Special considerations. See § 500.25 to occur should be retreated in 6 to 8 of this chapter. If labeled for adminis- weeks. Withholding feed or water prior tration by stomach tube: Federal law to use is unnecessary. Administer drug restricts this drug to use by or on the with caution to sick or debilitated order of a licensed veterinarian.

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(e) Conditions of use—(1) Horses. Use (b) Sponsor. See 054771 in § 510.600(c) of the product described in paragraph this chapter. (a)(1) of this section as follows: (c) Conditions of use—(1) Amount. 2.5 (i) Amount. 10 mg per kilogram (/kg) milligrams of oxfendazole and 40 milli- of body weight by stomach tube or dose grams of trichlorfon per kilogram of syringe. Horses maintained on prem- body weight. ises where reinfection is likely to occur (2) Indications for use. The drug is should be retreated in 6 to 8 weeks. used in horses for removal of bots (ii) Indications for use. For removal of (Gasterophilus intestinalis, 2nd and 3rd large roundworms (Parascaris equorum), instars; G. nasalis, 3rd instar) and the mature and 4th stage larvae pinworms following gastrointestinal worms: (Oxyuris equi), large strongyles Large roundworms (Parascaris (Strongylus edentatus, S. vulgaris, and S. equorum), pinworms (Oxyuris equi), equinus), and small strongyles. adult and 4th stage larvae; large strongyles (Strongylus edentatus, S. (iii) Limitations. Withholding feed or vulgaris, and S. equinus); and small water prior to use is unnecessary. Ad- strongyles. minister drug with caution to sick or (3) Limitations. Horses maintained on debilitated horses. Do not use in horses premises where reinfection is likely to intended for human consumption. occur should be retreated in 6 to 8 (2) Cattle. Use the products described weeks. Withholding feed or water be- in paragraphs (a)(1) and (a)(2) of this fore use is unnecessary. Administer section as follows: with caution to sick or debilitated (i) Amount. 4.5 mg/kg of body weight horses. Not for use in horses intended by dose syringe. Treatment may be re- for food. Do not administer to mares peated in 4 to 6 weeks. during the last month of pregnancy. (ii) Indications for use. For the re- Trichlorfon is a cholinesterase inhib- moval and control of: lungworms itor. Do not use this product in ani- (Dictyocaulus viviparus—adult, L4); mals simultaneously with, or within a stomach worms: barberpole worms few days before or after treatment with (Haemonchus contortus and H. placei— or exposure to, cholinesterase-inhib- adult), small stomach worms iting drugs, pesticides, or chemicals. (Trichostrongylus axei—adult), brown Consult your veterinarian for assist- stomach worms (Ostertagia ostertagi— ance in the diagnosis, treatment, and adult, L4, inhibited L4); intestinal control of parasitism. worms; nodular worms (Oesophagostomum radiatum—adult), [50 FR 50291, Dec. 10, 1985, as amended at 61 FR 5506, Feb. 13, 1996; 78 FR 28825, May 20, hookworms (Bunostomum 2014] phlebotomum—adult), small intestinal worms (Cooperia punctata, C. oncophora, § 520.1638 Oxibendazole. and C. surnabada—adult, L4), and tape- (a) Specifications—(1) Each gram of worms (Moniezia benedeni—adult). paste contains 227 milligrams (mg) (22.7 (iii) Limitations. Cattle must not be percent) oxibendazole. slaughtered until 7 days after treat- (2) Each milliliter of suspension con- ment. Because a withdrawal time in tains 100 mg (10 percent) oxibendazole. milk has not been established, do not (b) Sponsor. See No. 054771 in use in female dairy cattle of breeding § 510.600(c) of this chapter. age. (c) Special considerations—(1) See [55 FR 46943, Nov. 8, 1990, as amended at 56 § 500.25 of this chapter. FR 8710, Mar. 1, 1991; 61 FR 5506, Feb. 13, 1996; (2) Suspension product described in 72 FR 10596, Mar. 9, 2007; 73 FR 45610, Aug. 6, paragraph (a)(2) of this section shall be 2008; 75 FR 10166, Mar. 5, 2010; 78 FR 28825, labeled: ‘‘Federal law restricts this May 20, 2014] drug to use by or on the order of a licensed veterinarian.’’ § 520.1631 Oxfendazole and trichlorfon (d) Conditions of use in horses—(1) paste. Amount. For uses other than for (a) Specifications. Each gram of paste threadworms (Strongyloides westeri), 10 contains 28.5 milligrams oxfendazole mg oxibendazole per kilogram (/kg) and 454.5 milligrams trichlorfon. body weight; for threadworms

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(Strongyloides westeri), 15 mg/kg. Horses (air-sac infection) caused by Myco- maintained on premises where reinfec- plasma gallisepticum and secondary bac- tion is likely to occur should be re- terial organisms associated with chron- treated in 6 to 8 weeks. Administer sus- ic respiratory disease such as E. coli. pension product by stomach tube in 3 (3) Limitations. Not for use in chick- to 4 pints of warm water, or by top ens producing eggs for human con- dressing or mixing into a portion of the sumption. Withdraw 24 hours before normal grain ration. slaughter. Federal law restricts this (2) Indications for use. For removal drug to use by or on the order of a li- and control of large strongyles censed veterinarian. (Strongylus edentatus, S. equinus, S. vulgaris); small strongyles (genera [40 FR 13838, Mar. 27, 1975, as amended at 78 Cylicostephanus, Cylicocyclus, FR 28825, May 20, 2014; 81 FR 94989, Dec. 27, Cyathostomum, Triodontophorus, 2016] Cylicodontophorus, and Gyalocephalus); § 520.1660b Oxytetracycline hydro- large roundworms (Parascaris equorum); chloride capsules. pinworms (Oxyuris equi) including various larval stages; and threadworms (a) Specifications. The drug is in cap- (Strongyloides westeri). sule form with each capsule containing (3) Limitations. Do not use in horses 125 or 250 milligrams of oxytetracycline intended for human consumption. hydrochloride. Oxytetracycline is the antibiotic substance produced by [78 FR 28825, May 20, 2014] growth of Streptomyces rimosus or the same antibiotic substance produced by § 520.1660 Oxytetracycline. any other means. § 520.1660a Oxytetracycline and (b) Sponsor. See No. 054771 in carbomycin. § 510.600(c) of this chapter. (a) Specifications. (1) Oxytetracycline: (c) Conditions of use. (1) It is used in The antibiotic substance produced by dogs and cats for the treatment of bac- growth of Streptomyces rimosus or the terial pneumonia caused by Brucella same antibiotic substance produced by bronchiseptica, tonsilitis caused by any other means. Streptococcus hemolyticus, bacterial en- (2) Carbomycin: The antibiotic sub- teritis caused by Escherichia coli, uri- stance produced by growth of nary tract infections caused by Esch- Streptomyces halstedii or the same anti- erichia coli, and wound infections biotic substance produced by any other caused by Staphylococcus aureus. means. (2) The drug is administered orally to (b) Sponsor. See No. 054771 in dogs and cats at a dosage level of 25–50 § 510.600(c) of this chapter. milligrams per pound of body weight (c) Special considerations. The quan- per day in divided doses at 12-hour in- tities of oxytetracycline in paragraph tervals. The drug can be used for con- (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. Administer 1.0 gram of hours. If improvement is not observed oxytetracycline and 1.0 gram within that period, the diagnosis and carbomycin per gallon for not more course of treatment should be reconsid- than 5 days. ered. To assure adequate treatment, (2) Indications for use. As an aid in the administration of the drug should con- prevention and treatment of com- tinue for at least 48 hours following fa- plicated chronic respiratory disease vorable clinical response.

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(3) Federal law restricts this drug to calves. Do not use in calves to be proc- use by or on the order of a licensed vet- essed for veal. erinarian. [46 FR 32440, June 23, 1981, as amended at 50 [40 FR 13838, Mar. 27, 1975, as amended at 78 FR 1045, Jan. 9, 1985; 63 FR 70334, Dec. 21, FR 28825, May 20, 2014] 1998; 70 FR 16394, Apr. 4, 2005; 78 FR 28825, May 20, 2014] § 520.1660c Oxytetracycline hydrochloride tablets/boluses. § 520.1660d Oxytetracycline powder. (a) Specifications. Each tablet or bolus (a) Specifications. The drug is a solu- contains 250, 500, or 1,000 milligrams of ble powder distributed in packets or pails having several concentrations of oxytetracycline hydrochloride. oxytetracycline hydrochloride (inde- (b) Sponsors. For sponsors in pendent of the various net weights) as § 510.600(c) of this chapter: See 000010 follows: for use of 500 and 1,000 milligram (1) Each 18.14 grams of powder con- boluses. See No. 054771 for use of 250 tains 1 gram of oxytetracycline hydro- and 500 milligram tablets. chloride (OTC HCl) (packets: 4, 6.4, and (c) Tolerances. See § 556.500 of this 16 oz.). chapter. (2) Each 4.43 grams of powder con- (d) Conditions of use in beef and dairy tains 1 gram of OTC HCl (packets: 4 cattle—(1)(i) Amount. 250 milligrams per and 16 oz.). 100 pounds of body weight every 12 (3) Each 1.32 grams of powder con- hours (5 milligrams per pound of body tains 1 gram of OTC HCl (packets: 2.39, weight daily in two doses). 4.78, and 9.55 oz.; jars: 2.25 lbs.; and (ii) Indications for use. For control of pails: 4.5 lbs.). bacterial enteritis caused by Salmonella (4) Each 2.73 grams of powder con- typhimurium and Escherichia coli tains 1 gram of OTC HCl (packets: 2.46 (colibacillosis) and bacterial pneu- and 9.87 oz, 3.09 and 3.91 lb; pail: 3.09 lb). monia (shipping fever complex, (5) Each 4.2 grams of powder contains pasteurellosis) caused by Pasteurella 1 gram of OTC HCl (packets: 3.8 and multocida. 15.2 oz; pails: 4.74 and 23.7 lb). (2)(i) Amount. 500 milligrams per 100 (6) Each 1.32 grams of powder con- pound of body weight every 12 hours (10 tains 1 gram of OTC HCl (packet: 4.78 milligrams per pound of body weight oz.; pail: 5 lb). Each 2.73 grams of pow- daily in two doses). der contains 1 gram of OTC HCl (packet: 9.87 oz). (ii) Indications for use. For treatment (7) Each 1.32 grams of powder con- of bacterial enteritis caused by Sal- tains 1 gram of OTC HCl (packet: 4.78 monella typhimurium and Escherichia coli and 9.6 oz.; pails: 2 and 5 lb); each 18.1 (colibacillosis) and bacterial pneu- grams of powder contains 1 gram of monia (shipping fever complex, OTC HCl (packet: 6.4 oz.; pails: 2 and 5 pasteurellosis) caused by Pasteurella lb). multocida. (8) Each 135.5-gram packet (4.78 (3) Limitations. Dosage should con- ounce) contains 102.4 grams of OTC tinue until the animal returns to nor- HCl. Each 677.5-gram packet (23.9 mal and for 24 hours to 48 hours after ounce) contains 512 grams of OTC HCl. symptoms have subsided. Treatment (9) Each 2.73 grams of powder con- should not exceed 4 consecutive days. tains 1 gram of OTC HCl (packets: 9.87 Do not exceed 500 milligrams per 100 and, 19.75 oz, and 3.91 lb; pails: 3.09 and pounds of body weight every 12 hours 5 lb). (10 milligrams per pound daily). For (10) Each 2.73 grams of powder con- sponsor No. 054771: Discontinue treat- tains 1 gram of OTC HCl (packets: 9.87 ment 7 days prior to slaughter. Not for and 19.74 oz; pails: 5 lb). use in lactating dairy cattle. A with- (b) Sponsor. See sponsor numbers in drawal period has not been established § 510.600(c) of this chapter as follows: for this product in preruminating (1) No. 054771 for use of OTC HCl concentrations in paragraphs (a)(1), (a)(2), and (a)(3) of this section in chickens,

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turkeys, swine, cattle, sheep, and to 14 days. Not to be used for more honey bees. than 14 consecutive days. (2) No. 016592 for use of OTC HCl con- (2) Indications for use. Control of centration in paragraph (a)(4) of this hexamitiasis caused by Hexamita section in chickens, turkeys, and meleagridis susceptible to oxytetra- swine. cycline. (3) No. 066104 for use of OTC HCl con- (3) Do not use in birds producing eggs centration in paragraph (a)(5) of this for human consumption. Withdraw 5 section in turkeys and chickens. days prior to slaughter those products (4) No. 016592 for use of OTC HCl con- sponsored by Nos. 054771 and 061133 in centration in paragraph (a)(6) of this § 510.600(c) of this chapter. Withdraw 4 section in chickens, turkeys, and days prior to slaughter those products swine. sponsored by No. 054628. Zero-day with- (5) No. 061133 for use of OTC HCl con- drawal for those products sponsored by centration in paragraph (a)(7) of this Nos. 057561 and 069254. Federal law re- section in chickens, turkeys, swine, stricts this drug to use by or on the cattle, sheep, and honeybees. order of a licensed veterinarian. (6) No. 069254 for use of OTC HCl con- (B)(1) Amount. Administer 400 milli- centrations in paragraph (a)(8) of this grams/gallon for 7 to 14 days. Not to be section in chickens, turkeys, swine, used for more than 14 consecutive days. cattle, sheep, and honey bees. (2) Indications for use. Control of in- (7) No. 061133 for use of OTC HCl con- fectious synovitis caused by Myco- centration in paragraph (a)(9) of this section in chickens, turkeys, and plasma synoviae susceptible to oxytet- swine. racycline. (c) Related tolerances. See § 556.500 of (3) Do not use in birds producing eggs this chapter. for human consumption. Withdraw 5 (d) Conditions of use. (1) It is used in days prior to slaughter those products drinking water as follows: sponsored by Nos. 054771 and 061133 in (i) Chickens—(A)(1) Amount. Admin- § 510.600(c) of this chapter. Withdraw 4 ister 200 to 400 milligrams/gallon for 7 days prior to slaughter those products to 14 days. Not to be used for more sponsored by No. 054628. Zero-day with- than 14 consecutive days. drawal for those products sponsored by (2) Indications for use. Control of in- Nos. 057561 and 069254. Federal law re- fectious synovitis caused by Myco- stricts this drug to use by or on the plasma synoviae susceptible to oxytet- order of a licensed veterinarian. racycline. (C)(1) Amount. Administer 25 milli- (3) Do not use in birds producing eggs grams per pound of body weight daily for human consumption. Federal law for 7 to 14 days. Not to be used for more restricts this drug to use by or on the than 14 consecutive days. order of a licensed veterinarian. (2) Indications for use. Growing tur- (B)(1) Amount. Administer 400 to 800 keys. Control of complicating bacterial milligrams/gallon for 7 to 14 days. Not organisms associated with bluecomb to be used for more than 14 consecutive (transmissible enteritis, coronaviral days. enteritis) susceptible to oxytetra- (2) Indications for use. Control of cycline. chronic respiratory disease (CRD) and (3) Do not use in birds producing eggs air sac infections caused by Myco- for human consumption. Withdraw 5 plasma gallisepticum and E. coli suscep- days prior to slaughter those products tible to oxytetracycline; control of sponsored by Nos. 054771 and 061133 in fowl cholera caused by Pasteurella § 510.600(c) of this chapter. Withdraw 4 multocida susceptible to oxytetra- days prior to slaughter those products cycline. sponsored by No. 054628. Zero-day with- (3) Do not use in birds producing eggs drawal for those products sponsored by for human consumption. Federal law Nos. 057561 and 069254. Federal law re- restricts this drug to use by or on the stricts this drug to use by or on the order of a licensed veterinarian. order of a licensed veterinarian. (ii) Turkeys—(A)(1) Amount. Admin- (iii) Swine—(A) Amount. Administer ister 200 to 400 milligrams/gallon for 7 10 milligrams per pound of body weight

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daily for up to 14 days. Do not use for weight to weight) or dusting with a more than 14 consecutive days. powdered sugar mixture. The drug is (B) Indications for use. Control and administered in 3 applications of sugar treatment of bacterial enteritis caused syrup or 3 dustings at 4- to 5-day inter- by Escherichia coli and Salmonella vals. choleraesuis and bacterial pneumonia (ii) Indications for use. For control of caused by Pasteurella multocida suscep- American foulbrood caused by tible to oxytetracycline. For breeding Paenibacillus larvae. swine: Control and treatment of lepto- (iii) The drug should be fed early in spirosis (reducing the incidence of the spring or fall and consumed by the abortions and shedding of leptospira) bees before main honey flow begins to caused by Leptospira pomona suscep- avoid contamination of production tible to oxytetracycline. honey. Remove at least 6 weeks prior (C) Withdraw zero days prior to to main honey flow. Federal law re- slaughter those products sponsored by stricts this drug to use by or on the Nos. 054771, 057561, 061133, and 069254 in order of a licensed veterinarian. § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products [40 FR 13838, Mar. 27, 1975] sponsored by No. 054628. Federal law re- EDITORIAL NOTE: For FEDERAL REGISTER ci- stricts this drug to use by or on the tations affecting § 520.1660d, see the List of order of a licensed veterinarian. CFR Sections Affected, which appears in the (iv) Calves, beef cattle, and nonlac- Finding Aids section of the printed volume tating dairy cattle—(A) Amount. Admin- and at www.govinfo.gov. ister 10 milligrams per pound of body weight daily for up to 14 days. Do not § 520.1696 Penicillin. use for more than 14 consecutive days. (B) Indications for use. Control and § 520.1696a Penicillin G powder. treatment of bacterial enteritis caused (a) Specifications. Each gram of pow- by E. coli and bacterial pneumonia der contains penicillin G potassium (shipping fever complex) caused by P. equivalent to 1.54 million units of peni- multocida susceptible to oxytetra- cillin G. cycline. (b) Sponsors. See Nos. 010515, 016592, (C) Withdraw 5 days prior to slaugh- 054771, 061133 and 076475 in § 510.600(c) of ter. A milk discard period has not been this chapter. established for this product in lac- (c) Related tolerances. See § 556.510 of tating dairy cattle. Do not use in fe- this chapter. male dairy cattle 20 months of age or (d) Conditions of use in turkeys—(1) older. Federal law restricts this drug to Amount. 1,500,000 units per gallon use by or on the order of a licensed vet- drinking water for 5 days. erinarian. (2) Indications for use. Treatment of (v) Sheep—(A) Amount. Administer 10 erysipelas caused by Erysipelothrix milligrams per pound of body weight rhusiopathiae. daily for up to 14 days. Not to be used for more than 14 consecutive days. (3) Limitations. Discontinue treat- (B) Indications for use. Control and ment at least 1 day prior to slaughter. treatment of bacterial enteritis caused Not for use in turkeys producing eggs by E. coli and bacterial pneumonia for human consumption. Federal law (shipping fever complex) caused by P. restricts this drug to use by or on the multocida susceptible to oxytetra- order of a licensed veterinarian. cycline. [57 FR 37326, Aug. 18, 1992, as amended at 59 (C) Withdraw 5 days prior to slaugh- FR 42493, Aug. 18, 1994; 60 FR 26359, May 17, ter. Federal law restricts this drug to 1995; 62 FR 55160, Oct. 23, 1997; 65 FR 10705, use by or on the order of a licensed vet- Feb. 29, 2000; 66 FR 14073, Mar. 9, 2001; 68 FR erinarian. 4914, Jan. 31, 2003; 68 FR 26204, May 15, 2003; (2) It is used in the food of honey bees 69 FR 9946, Mar. 3, 2004; 69 FR 41428, July 9, 2004; 77 FR 20988, Apr. 9, 2012; 78 FR 28825, as follows: May 20, 2014; 81 FR 22523, Apr. 18, 2016; 81 FR (i) Amount. 200 milligrams per colony, 36789, June 8, 2016; 81 FR 94990, Dec. 27, 2016; administered via either a 1:1 sugar 84 FR 8973, Mar. 13, 2019. Redesignated at 85 syrup (equal parts of sugar and water FR 18119, Apr. 1, 2020]

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§ 520.1696b Penicillin V powder. kg) once daily. Dosage may be adjusted to effect, not to exceed 4 μg/kg daily. (a) Specifications. When reconstituted, each milliliter contains 25 milligrams (2) Indications for use. For the control (40,000 units) of penicillin V. of clinical signs associated with Pitui- (b) Sponsor. See No. 000010 in tary Pars Intermedia Dysfunction § 510.600(c) of this chapter. (Equine Cushing’s Disease). (c) Conditions of use in dogs and cats— (3) Limitations. Federal law restricts (1) Amount. 10 to 15 milligrams per this drug to use by or on the order of a pound of body weight every 6 to 8 licensed veterinarian. hours. [77 FR 15960, Mar. 19, 2012, as amended at 81 (2) Indications for use. Treatment of FR 22523, Apr. 18, 2016] respiratory, urogenital, skin, and soft tissue infections and septicemia caused § 520.1720 Phenylbutazone oral dosage by pathogens susceptible to penicillin forms. V potassium. (3) Limitations. Federal law restricts § 520.1720a Phenylbutazone tablets this drug to use by or on the order of a and boluses. licensed veterinarian. (a) Specifications. Each tablet con- [57 FR 37326, Aug. 18, 1992; 57 FR 42623, Sept. tains 100, 200, or 400 milligrams (mg), or 15, 1992; 77 FR 20988, Apr. 9, 2012; 78 FR 28826, 1 gram (g) of phenylbutazone. Each May 20, 2014; 84 FR 39183, Aug. 9, 2019. Redes- bolus contains 1, 2, or 4 gram g of ignated at 85 FR 18119, Apr. 1, 2020] phenylbutazone. (b) Sponsors. See sponsor numbers in § 520.1696c Penicillin V tablets. § 510.600(c) of this chapter, as follows: (a) Specifications. Each tablet con- (1) No. 000061 for use of 100- or 400-mg tains penicillin V potassium equivalent or 1-g tablets, or 2- or 4-g boluses, in to 125 milligrams (200,000 units) or 250 dogs and horses. milligrams (400,000 units) of penicillin (2) No. 069043 for use of 100- or 200-mg V. or 1-g tablets in dogs and horses. (b) Sponsors. See Nos. 000010 and (3) Nos. 054771 and 061133 for use of 054771 in § 510.600(c) of this chapter. 100-mg or 1-g tablets in dogs and (c) Conditions of use in dogs and cats— horses. (1) Amount. 10 to 15 milligrams per (4) [Reserved] pound of body weight every 6 to 8 (5) No. 000143 for use of 1-g tablets in hours. horses. (2) Indications for use. Treatment of respiratory, urogenital, skin and soft (6) No. 058829 for use of 100-mg or 1-g tissue infections and septicemia caused tablets in dogs and horses. by pathogens susceptible to penicillin (c) Conditions of use—(1) Dogs—(i) V potassium. Amount. 20 mg per pound of body (3) Limitations. Federal law restricts weight daily. this drug to use by or on the order of a (ii) Indications for use. For the relief licensed veterinarian. of inflammatory conditions associated with the musculoskeletal system. [57 FR 37327, Aug. 18, 1992, as amended at 59 (iii) Limitations. Federal law restricts FR 58775, Nov. 15, 1994; 78 FR 28826, May 20, 2014; 84 FR 39183, Aug. 9, 2019. Redesignated this drug to use by or on the order of a at 85 FR 18119, Apr. 1, 2020] licensed veterinarian. (2) Horses—(i) Amount. 1 to 2 g per 500 § 520.1705 Pergolide. pounds of body weight daily. (a) Specifications. Each tablet con- (ii) Indications for use. For the relief tains 1 milligram (mg) peroglide (as of inflammatory conditions associated pergolide mesylate). with the musculoskeletal system. (b) Sponsor. See No. 000010 in (iii) Limitations. Do not use in horses § 510.600(c) of this chapter. intended for human consumption. Fed- (c) Conditions of use in horses—(1) eral law prohibits the use of this drug Amount. Administer orally at a start- in female dairy cattle 20 months of age ing dose of 2 micrograms/kilograms (μ/ or older. Federal law restricts this drug

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to use by or on the order of a licensed eral law prohibits the use of this drug veterinarian. in female dairy cattle 20 months of age or older. Federal law restricts this drug [73 FR 8192, Feb. 13, 2008, as amended at 74 FR 1146, Jan. 12, 2009; 76 FR 11331, Mar. 2, to use by or on the order of a licensed 2011; 76 FR 17777, Mar. 31, 2011; 78 FR 21060, veterinarian. Apr. 9, 2013; 78 FR 28826, May 20, 2014; 81 FR [45 FR 84762, Dec. 23, 1980, as amended at 58 17607, Mar. 30, 2016; 83 FR 48946, Sept. 28, 2018; FR 29777, May 24, 1993; 61 FR 8873, Mar. 6, 84 FR 8973, Mar. 13, 2019] 1996; 62 FR 61625, Nov. 19, 1997; 68 FR 43926, § 520.1720b Phenylbutazone granules. July 25, 2003; 72 FR 60550, Oct. 25, 2007; 77 FR 4897, Feb. 1, 2012; 78 FR 28826, May 20, 2014; 79 (a) Specifications. Each package of FR 74020, Dec. 15, 2014] granules contains 1 or 8 grams of phenylbutazone. § 520.1720d Phenylbutazone gel. (b) Sponsors. See sponsors in (a) Specifications. Each 30 grams of gel § 510.600(c) of this chapter. contains 4 grams of phenylbutazone. (1) No. 000061 for 8-gram package. (b) Sponsor. See No. 061133 in (2) No. 059320 for 1-gram package. § 510.600(c) of this chapter. require bio- (c) Conditions of use in horses—(1) equivalency and safety information. Amount. Administer 1 to 2 grams per 500 pounds of body weight, not to ex- (c) Conditions of use in horses—(1) ceed 4 grams, daily as required. by add- Amount. 1 to 2 grams of phenylbutazone ing to a portion of the usual grain ra- per 500 pounds of body weight, not to tion. exceed 4 grams daily. (2) Indications for use. For the treat- (2) Indications for use. For relief of in- ment of inflammatory conditions asso- flammatory conditions associated with ciated with the musculoskeletal sys- the musculoskeletal system of horses. tem. (3) Limitations. Do not use in horses (3) Limitations. Do not use in horses intended for human consumption. Fed- intended for human consumption. Fed- eral law prohibits the use of this drug eral law prohibits the use of this drug in female dairy cattle 20 months of age in female dairy cattle 20 months of age or older. Federal law restricts this drug or older. Federal law restricts this drug to use by or on the order of a licensed to use by or on the order of a licensed veterinarian. veterinarian. [50 FR 13561, Apr. 5, 1985, as amended at 50 [78 FR 28826, May 20, 2014] FR 49372, Dec. 2, 1985; 55 FR 8462, Mar. 8, 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, § 520.1720c Phenylbutazone paste. 2003; 78 FR 28826, May 20, 2014; 84 FR 8973, Mar. 13, 2019] (a) Specifications—(1) Each gram of paste contains 0.2 grams § 520.1720e Phenylbutazone powder. phenylbutazone. (2) Each gram of paste contains 0.35 (a) Specifications—(1) Each 1.15 grams grams phenylbutazone. (g) of powder contains 1 g (b) Sponsors. See sponsor numbers in phenylbutazone. § 510.600(c) of this chapter. (2) Each 10 g of powder contains 1 g (1) No. 000061 for use of product de- phenylbutazone. scribed in paragraph (a)(1) of this sec- (b) Sponsors. See sponsor numbers in tion. § 510.600(c) of this chapter. (2) No. 017030 for use of product de- (1) No. 027053 for use of product described in paragraph (a)(2) of this sec- scribed in paragraph (a)(1) of this section. tion. (c) Conditions of use in horses—(1) (2) No. 057699 for use of product de- Amount. 1 to 2 grams of phenylbutazone scribed in paragraph (a)(2) of this sec- per 500 pounds of body weight, not to tion. exceed 4 grams daily. (c) Conditions of use in horses—(1) (2) Indications for use. For relief of in- Amount. Administer 1 to 2 g (1 to 2 level flammatory conditions associated with scoops, using the scoop provided) per the musculoskeletal system. 500 pounds of body weight on a small (3) Limitations. Do not use in horses amount of palatable feed, not exceed 4 intended for human consumption. Fed- g per animal daily.

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(2) Indications for use. For the relief of dilated cardiomyopathy; for use with inflammatory conditions associated concurrent therapy for congestive with the musculosketetal system. heart failure as appropriate on a case- (3) Limitations. Do not use in horses by-case basis. intended for human consumption. Fed- (3) Limitations. Federal law restricts eral law prohibits the extralabel use of this drug to use by or on the order of a this product in female cattle 20 months licensed veterinarian. of age or older. Federal law restricts [72 FR 27733, May 17, 2007, as amended at 79 this drug to use by or on the order of a FR 18158, Apr. 1, 2014] licensed veterinarian. [72 FR 27956, May 18, 2007] § 520.1802 Piperazine-carbon disulfide complex oral dosage forms. § 520.1760 Phenylpropanolamine. § 520.1802a Piperazine-carbon disul- (a) Specifications. (1) Each chewable fide complex suspension. tablet contains 25, 50, or 75 milligram (a) Specifications. Each fluid ounce of (mg) phenylpropanolamine hydro- suspension contains 7.5 grams of piper- chloride. azine-carbon disulfide complex. The pi- (2) Each extended-release tablet con- perazine-carbon disulfide complex contains 18, 38, 74, or 145 mg phenyl- tains equimolar parts of piperazine and propanolamine hydrochloride. carbon disulfide (1 gram contains 530 (b) Sponsors. See No. 055246 in mgs of piperazine and 470 mgs of carbon § 510.600(c) of this chapter. disulfide). (c) Conditions of use in dogs—(1) (b) Sponsor. See No. 054771 in Amount. Administer orally as follows: § 510.600(c) of this chapter. (i) Chewable tablet: 2 mg/kg of body (c) Conditions of use in horses and weight twice daily. ponies—(1) Amount. Administer 1 fluid (ii) Extended-release tablet: 2 to 4 ounce per 100 pounds of body weight by mg/kg of body weight once daily with stomach tube or dose syringe after food. withholding feed overnight or for 8 to (2) Indications for use. For the control 10 hours. of urinary incontinence due to urethral (2) Indications for use. For removing sphincter hypotonus in dogs. ascarids (large roundworms, Parascaris (3) Limitations. Federal law restricts equorum), bots (Gastrophilus spp.), small this drug to use by or on the order of a strongyles, large strongyles (Strongyles licensed veterinarian. spp.), and pinworms (Oxyuris equi). [77 FR 15961, Mar. 19, 2012, as amended at 84 (3) Limitations. Do not use in horses FR 39183, Aug. 9, 2019] intended for human consumption. Fed- eral law restricts this drug to use by or § 520.1780 Pimobendan. on the order of a licensed veterinarian. (a) Specifications. Each chewable tab- [45 FR 52781, Aug. 8, 1980, as amended at 78 let contains 1.25, 2.5, 5, or 10 milligrams FR 28826, May 20, 2014] (mg) pimobendan. (b) Sponsor. See No. 000010 in § 520.1802b Piperazine-carbon disul- § 510.600(c) of this chapter. fide complex boluses. (c) Conditions of use in dogs—(1) (a) Specifications. Each bolus contains Amount. Administer orally at a total 20 grams of piperazine-carbon disulfide daily dose of 0.23 mg per pound (0.5 mg complex. per kilogram) body weight, using a (b) Sponsor. See No. 054771 in suitable combination of whole or half § 510.600(c) of this chapter. tablets. The total daily dose should be (c) Conditions of use in horses and divided into two portions administered ponies—(1) Amount. For removal of approximately 12 hours apart. ascarids and small strongyles, 1 bolus (2) Indications for use. For the man- (20 grams) per 500 pounds body weight; agement of the signs of mild, mod- removal of large strongyles, pinworms, erate, or severe (modified New York and bots, 1 bolus per 250 pounds body Heart Association Class II, III, or IV) weight. congestive heart failure due to atrio- (2) Indications for use. For removing ventricular valvular insufficiency or ascarids (large roundworms, Parascaris

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equorum), large strongyles (Strongylus (b) Sponsor. See No. 021091 in spp.) bots (Gastrophilus spp.), small § 510.600(c) of this chapter. strongyles, and pinworms (Oxyuris (c) Conditions of use in dogs and cats— equi). (1) Amount. The contents of 1 capsule (3) Limitations. Withhold feed over- should be mixed with the food of the night or for 8 to 10 hours. Give water animal for each 5 pounds, or fraction just before and/or after treatment. Re- thereof of body weight, except dogs sume regular feeding 4 to 6 hours after weighing over 25 pounds should be treatment. Treatment of debilitated or given the contents of 6 capsules. The anemic animals is contraindicated. Do drug should be mixed in 1/2 of the reg- not administer to animals that are or ular feeding and when the animal has were recently affected with colic, diar- finished eating the dosed food, the re- rhea, or infected with a serious infec- mainder of the food may be given. Dogs tious disease. As with most and cats may be wormed at 6 to 8 anthelmintics, drastic cathartics or weeks of age. The first treatment other gastrointestinal irritants should should be repeated 10 days later. Rein- not be administered in conjunction fection may occur. Repeat treatment if with this drug. Animals in poor condi- indicated. tion or heavily parasitized should be (2) Indications for use. For the re- given one half the recommended dose moval of large roundworms (Toxocara and treated again in 2 or 3 weeks. Con- canis and Toxascaris leonina). sult your veterinarian for assistance in (3) Limitations. Severely debilitated the diagnosis, treatment, and control animals should not be treated except of parasitism. on the advice of a veterinarian. [45 FR 52782, Aug. 8, 1980, as amended at 78 [40 FR 13838, Mar. 27, 1975, as amended at 54 FR 28826, May 20, 2014] FR 38515, Sept. 19, 1989; 78 FR 28826, May 20, § 520.1802c Piperazine-carbon disul- 2014] fide complex with phenothiazine suspension. § 520.1805 Piperazine phosphate with thenium closylate tablets. (a) Specifications. Each fluid ounce contains 5 grams of piperazine-carbon (a) Specifications. Each scored tablet disulfide complex and 0.83 gram of contains the equivalent of 250 milli- phenothiazine. grams piperazine hexahydrate (as pi- (b) Sponsor. See No. 054771 in perazine phosphate) and 125 milligrams § 510.600(c) of this chapter. thenium (as thenium closylate) or 500 milligrams piperazine hexahydrate (as (c) Conditions of use in horses and piperazine phosphate) and 250 milli- ponies—(1) Amount. Administer 1 fluid grams thenium (as thenium closylate). ounce per 100 pounds of body weight by stomach tube or dose syringe after (b) Sponsor. See No. 000061 in withholding feed overnight or for 8 to § 510.600(c) of this chapter. 10 hours. (c) Conditions of use—(1) Amount. Ad- (2) Indications for use. For removing minister orally to dogs as follows: ascarids (large roundworms, Parascaris equorum), bots (Gastrophilus spp.), small NUMBER OF TABLETS AT EACH OF THE TWO strongyles, and large strongyles DOSES (Strongylus spp.). Animal weight (lb) 375 mg 750 mg (3) Limitations. Do not use in horses intended for human consumption. Fed- 2 but less than 5 ...... 1⁄2 ...... eral law restricts this drug to use by or 5 but less than 10 ...... 1 1⁄2 on the order of a licensed veterinarian. 10 or heavier ...... 2 1 [45 FR 52782, Aug. 8, 1980, as amended at 78 (2) Indications for use. For removal of FR 28826, May 20, 2014] immature (fourth stage larvae) and adult hookworms (Ancylostoma § 520.1803 Piperazine citrate capsules. caninum, A. braziliense, and Uncinaria (a) Specifications. Each capsule con- stenocephala) and ascarids (Toxocara tains piperazine citrate equivalent to canis) from weaned pups and adult 140 milligrams of piperazine base. dogs.

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(3) Limitations. Federal law restricts block (1.5 grams poloxalene) per 100 lbs. this drug to use by or on the order of a of body weight per day. licensed veterinarian. (3) For prevention of legume (alfalfa, [43 FR 32747, July 28, 1978, as amended at 47 clover) and wheat pasture bloat in cat- FR 55476, Dec. 10, 1982; 61 FR 8873, Mar. 6, tle. A 53-percent poloxalene top dress- 1996; 62 FR 61625, Nov. 19, 1997; 78 FR 28826, ing on individual rations of ground May 20, 2014] feed. Dosage is 1 gram of poloxalene per 100 pounds of body weight daily. If § 520.1806 Piperazine suspension. bloating conditions are severe, the dose (a) Specifications. Each milliliter of is doubled. Treatment should be start- suspension contains piperazine ed 2 to 3 days before exposure to bloat- monohydrochloride equivalent to 33.5 producing conditions. Repeat use of the milligrams (mg) piperazine base. drug if animals are exposed to bloat- (b) Sponsor. See No. 017135 in producing conditions for more than 12 § 510.600(c) of this chapter. hours after the last treatment. Do not (c) Special considerations. See exceed the double dose in any 24-hour § 500.25(c) of this chapter. period. (d) Conditions of use in dogs—(1) Indi- cations for use. For the removal of [40 FR 13838, Mar. 27, 1975, as amended at 40 roundworms (Toxocara canisand FR 39857, Aug. 29, 1975; 42 FR 41854, Aug. 19, Toxascaris leonina). 1977; 50 FR 5385, Feb. 8, 1985; 54 FR 33501, Aug. (2) Dosage. Administer 20 to 30 mg pi- 15, 1989; 56 FR 50653, Oct. 8, 1991; 58 FR 26523, perazine base per pound body weight as May 4, 1993; 60 FR 55659, Nov. 2, 1995; 66 FR a single dose. 47963, Sept. 17, 2001; 69 FR 62811, Oct. 28, 2004; (3) Limitations. Administer by mixing 70 FR 32489, June 3, 2005; 78 FR 28826, May 20, 2014; 83 FR 48946, Sept. 28, 2018; 84 FR 32992, into the animal’s ration to be con- July 11, 2019] sumed at one feeding. For animals in heavily contaminated areas, reworm at § 520.1846 Polyoxyethylene (23) lauryl monthly intervals. Not for use in ether blocks. unweaned pups or animals less than 3 weeks of age. (a) Specifications. Each molasses- based block contains 2.2 percent [70 FR 17319, Apr. 6, 2005] polyoxyethylene (23) lauryl ether. (b) Sponsor. See No. 067949 in § 520.1840 Poloxalene. § 510.600(c) of this chapter. (a) Specifications. Polyoxypropylene- (c) Conditions of use—(1) Amount. 2 polyoxyethylene glycol nonionic block grams of polyoxyethylene (23) lauryl polymer. ether per 100 kilograms of body weight (b) Sponsors. See sponsors in per day (1 pound of block per 500 kilo- § 510.600(c) of this chapter for use as in gram (1,100 pound) animal per day). paragraph (d) of this section. (1) No. 054771 for use as in paragraphs (2) Indications for use. For reduction (d)(1) and (d)(3) of this section. of the incidence of bloat (alfalfa and (2) No. 067949 for use as in paragraph clover) in pastured cattle. (d)(2) of this section. (3) Limitations. Administer free- (3) No. 066104 for use as in paragraph choice to beef cattle and nonlactating (d)(3) of this section. dairy cattle only. Initially, provide one (c) Related tolerances. See § 556.517 of block per five head of cattle. Start this chapter. treatment 10 to 14 days before exposure (d) Conditions of use. (1) For treat- to bloat-producing pastures. Do not ment of legume (alfalfa, clover) bloat allow cattle access to other sources of in cattle. Administer as a drench at the salt while being fed this product. Do rate of 25 grams for animals up to 500 not feed this product to animals with- pounds and 50 grams for animals over out adequate forage/roughage consump- 500 pounds of body weight. tion. (2) For control of legume (alfalfa, clover) bloat in cattle. Administer, in mo- [50 FR 48189, Nov. 22, 1985, as amended at 56 lasses block containing 6.6 percent FR 9841, Mar. 8, 1991; 69 FR 62811, Oct. 28, poloxalene, at the rate of 0.8 oz. of 2004]

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§ 520.1855 Ponazuril. this section as in paragraph (c)(1) of (a) Specifications. Each gram of paste this section; and for use of the product contains 150 milligrams (mg) ponazuril. described in paragraph (a)(2) of this (b) Sponsor. See No. 000010 in section as in paragraph (c)(2) of this § 510.600(c) of this chapter. section. (c) Conditions of use in horses—(1) (c) Conditions of use—(1) Dogs—(i) 1 Amount. Administer orally 15 mg per Amount. 5 pounds (lb) and under, ⁄2 tab- kilogram (kg) (6.81 mg per pound (lb)) let (17 mg); 6 to 10 lb, 1 tablet (34 mg); 1 body weight as the first dose, followed 11 to 15 lb, 1 ⁄2 tablets (51 mg); 16 to 30 by 5 mg/kg (2.27 mg/lb) body weight lb, 2 tablets (68 mg); 31 to 45 lb, 3 tab- once daily for a period of 27 additional lets (102 mg); 46 to 60 lb, 4 tablets (136 days. mg); over 60 lb, 5 tablets maximum (170 (2) Indications for use. For the treat- mg). Administer directly by mouth or ment of equine protozoal crumbled and in feed. myeloencephalitis caused by Sarcocystis (ii) Indications for use—(A) For re- neurona. moval of canine cestodes Dipylidium (3) Limitations. Do not use in horses caninum and Taenia pisiformis. intended for human consumption. Fed- (B) For removal of the canine cestode eral law restricts this drug to use by or Echinococcus granulosus, and for re- on the order of a licensed veterinarian. moval and control of the canine cestode Echinococcus multilocularis. [66 FR 43774, Aug. 21, 2001, as amended at 79 (iii) Limitations—(A) If labeled only FR 28827, May 20, 2014; 80 FR 34278, June 16, for use as in paragraph (c)(1)(ii)(A) of 2015; 80 FR 53459, Sept. 4, 2015; 84 FR 39183, this section: Not intended for use in Aug. 9, 2019] puppies less than 4 weeks of age. Con- § 520.1860 Pradofloxacin. sult your veterinarian before administering tablets to weak or debilitated (a) Specifications. Each milliliter of animals and for assistance in the diag- suspension contains 25 milligrams (mg) nosis, treatment, and control of para- pradofloxacin. sitism. (b) Sponsor. See No. 000859 in (B) If labeled for use as in paragraph § 510.600(c) of this chapter. (c)(1)(ii)(B) of this section: Federal law (c) —(1) Conditions of use in cats restricts this drug to use by or on the Administer 3.4 mg/lb (7.5 mg/ Amount. order of a licensed veterinarian. kg) body weight once daily for 7 con- (2) Cats—(i) Indications for use. For re- secutive days. moval of feline cestodes Dipylidium (2) Indications for use. For the treat- caninum and Taenia taeniaeformis. ment of skin infections (wounds and (ii) Dosage. Cats 4 pounds and under, abscesses) in cats caused by susceptible 11.5 mg; 5 to 11 pounds, 23 mg; over 11 strains of Pasteurella multocida, Strepto- pounds, 34.5 mg. coccus canis, Staphylococcus aureus, (iii) Limitations. Administer directly and Staphylococcus felis, Staphylococcus by mouth or crumbled and in feed. Not pseudintermedius. intended for use in kittens less than 6 (3) Federal law prohibits Limitations. weeks of age. For OTC use: Consult the extralabel use of this drug in food- your veterinarian before administering producing animals. Federal law re- tablets to weak or debilitated animals, stricts this drug to use by or on the and for assistance in the diagnosis, order of a licensed veterinarian. treatment, and control of parasitism. [77 FR 76863, Dec. 31, 2012, as amended at 79 [46 FR 60570, Dec. 11, 1981, as amended at 47 FR 28827, May 20, 2014] FR 26377, June 18, 1982; 55 FR 2234, Jan. 23, 1990; 58 FR 7864, Feb. 10, 1993; 58 FR 42853, § 520.1870 Praziquantel tablets. Aug. 12, 1993; 68 FR 57351, Oct. 3, 2003; 69 FR (a) Specifications. Each tablet con- 62181, Oct. 25, 2004; 78 FR 17596, Mar. 22, 2013; tains: 81 FR 17607, Mar. 30, 2016] (1) 34 milligrams (mg) praziquantel. (2) 11.5 or 23 mg praziquantel. § 520.1871 Praziquantel and pyrantel. (b) Sponsor. See No. 069043 in (a) Specifications. (1) Each tablet con- § 510.600(c) of this chapter for use of the tains 13.6 milligrams (mg) praziquantel product described in paragraph (a)(1) of and 54.3 mg pyrantel base (as pyrantel

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pamoate), 18.2 mg praziquantel and 72.6 (Dipylidium caninum and Taenia mg pyrantel base (as pyrantel pisiformis) in dogs and puppies. pamoate), or 27.2 mg praziquantel and [58 FR 58652, Nov. 3, 1993, as amended at 72 108.6 mg pyrantel base (as pyrantel FR 16270, Apr. 4, 2007; 75 FR 54018, Sept. 3, pamoate). 2010] (2) Each chewable tablet contains 30 mg praziquantel and 30 mg pyrantel § 520.1872 Praziquantel, pyrantel pamoate or 114 mg praziquantel and 114 pamoate, and febantel tablets. mg pyrantel pamoate. (a) Specifications. Each tablet or (b) Sponsors. See sponsors in chewable tablet contains either: § 510.600(c) for use as in paragraph (d) of (1) Tablet No. 1: 22.7 milligrams this chapter. praziquantel, 22.7 milligrams pyrantel (1) See No. 000859 for use of tablets base, and 113.4 milligrams febantel; or described in paragraph (a)(1) of this (2) Tablet No. 2: 68 milligrams section for use as in paragraph (d)(1) of praziquantel, 68 milligrams pyrantel this section. base, and 340.2 milligrams febantel. (3) Tablet No. 3: 136 milligrams (mg) (2) See No. 051311 for use of tablets praziquantel, 136 mg pyrantel base, and described in paragraph (a)(2) of this 680.4 mg febantel. section for use as in paragraph (d)(2) of (b) Sponsor. See 000859 in § 510.600(c) of this section. this chapter. (c) Special considerations. See § 500.25 (c) Conditions of use—(1) Dogs—(i) of this chapter. Amount. Administer as a single dose di- (d) Conditions of use—(1) Cats—(i) Dos- rectly by mouth or in a small amount age. Administer a minimum dose of 2.27 of food as follows: mg praziquantel and 9.2 mg pyrantel pamoate per pound of body weight ac- Weight of animal Number of tablets per dose

cording to the dosing tables on label- Kilograms Pounds Tablet Tablet Tablet ing. May be given directly by mouth or no. 1 no. 2 no. 3 in a small amount of food. Do not with- 0.9 to 1.8 ...... 2 to 4 ...... 1/2. hold food prior to or after treatment. If 2.3 to 3.2 ...... 5 to 7 ...... 1. reinfection occurs, treatment may be 3.6 to 5.4 ...... 8 to 12 ..... 1 1/2. 5.9 to 8.2 ...... 13 to 18 ... 2. repeated. 8.6 to 11.4 .... 19 to 25 ... 2 1/2. (ii) Indications for use. For removal of 11.8 to 13.6 .. 26 to 30 ...... 1. tapeworms (Dipylidium caninum and 14.1 to 20.0 .. 31 to 44 ...... 1 1/2. 20.4 to 27.2 .. 45 to 60 ...... 2 ...... 1 Taenia taeniaeformis), hookworms 27.7 to 40.9 .. 61 to 90 ...... 1 1/2 (Ancylostoma tubaeforme), and large 41.3 to 54.5 .. 91 to 120 ...... 2 roundworms (Toxocara cati) in cats and kittens. (ii) Indications for use. For the re- (iii) Limitations. Not for use in kit- moval of tapeworms (Dipylidium tens less than 2 months of age or caninum, Taenia pisiformis, Echinococcus weighing less than 2.0 pounds. Consult granulosus); hookworms (Ancylostoma caninum, Uncinaria stenocephala); your veterinarian before giving to sick ascarids (Toxocara canis, Toxascaris or pregnant animals. leonina); and whipworms (Trichuris (2) Dogs—(i) Amount. Administer a vulpis) and for the removal and control minimum dose of 5 mg praziquantel of tapeworm Echinococcus multilocularis and 5 mg pyrantel pamoate per kilo- in dogs. gram body weight (2.27 mg praziquantel (iii) Limitations. Do not use in preg- and 2.27 mg pyrantel pamoate per nant animals. Do not use in dogs pound body weight) according to the weighing less than 0.9 kilogram (2 dosing tables on labeling. pounds) or puppies less than 3 weeks of (ii) Indications for use. For the treat- age. Federal law restricts this drug to ment and control of roundworms use by or on the order of a licensed vet- (Toxocara canis and Toxascaris leonina), erinarian. hookworms (Ancylostoma caninum, [59 FR 33908, July 1, 1994, as amended at 61 Ancylostoma braziliense, and Uncinaria FR 29651, June 12, 1996; 68 FR 22293, Apr. 28, stenocephala), and tapeworms 2003; 71 FR 6677, Feb. 9, 2006]

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§ 520.1880 Prednisolone. § 520.1920 Prochlorperazine and isopropamide. (a) Specifications. Each tablet contains 5 or 20 milligrams prednisolone. (a) Specifications. Each capsules con- (b) Sponsor. See No. 061690 in tains either: § 510.600(c)(2) of this chapter. (1) 3.33 milligrams of (c) Conditions of use in dogs—(1) prochlorperazine (as the dimaleate) Amount. Administer 2.5 milligrams per and 1.67 milligrams of isopropamide (as 4.5 kilograms (10 pounds) body weight the iodide); or per day. Administer total daily dose (2) 10 milligrams of prochlorperazine orally in equally divided doses 6 to 10 (as the dimaleate) and 5 milligrams of hours apart until response is noted or 7 isopropamide (as the iodide). days have elapsed. When response is at- (b) Sponsor. See No. 054771 in tained, dosage should be gradually re- § 510.600(c) of this chapter. duced until maintenance level is (c) Conditions of use in dogs—(1) achieved. Amount. (i) Capsules described in para- (2) Indications for use. For use as an graph (a)(1) of this section are adminis- anti-inflammatory agent. tered orally to dogs weighing from 4 to (3) Limitations. Federal law restricts 15 pounds at the rate of 1 capsule twice this drug to use by or on the order of a daily. These capsules are administered licensed veterinarian. orally to dogs weighing from 16 to 30 pounds at the rate of 1 or 2 capsules [57 FR 4718, Feb. 7, 1992, as amended at 60 FR twice daily. For dogs weighing less 57832, Nov. 22, 1995; 63 FR 148, Jan. 5, 1998; 79 than 4 pounds, administer orally an ap- FR 28827, May 20, 2014] propriate fraction of the contents of one of these capsules. § 520.1900 Primidone. (ii) Capsules described in paragraph (a) Specifications. Each tablet con- (a)(2) of this section are given to dogs tains 50 or 250 milligrams of primidone. weighing 30 pounds and over at the rate (b) Sponsors. See sponsor numbers in of 1 capsule twice daily. § 510.600(c) of this chapter. (2) Indications for use. For the treat- (1) No. 069043 for use of 250 milligram ment of gastrointestinal disturbances tablets. associated with emotional stress. (2) No. 054771 for use of 50 and 250 mil- (3) Limitations. Federal law restricts ligram tablets. this drug to use by or on the order of a (c) Conditions of use in dogs—(1) licensed veterinarian. Amount. Twenty-five milligrams of [79 FR 28827, May 20, 2014] primidone per pound of body weight (55 milligrams per kilogram of body § 520.1921 Prochlorperazine, weight) daily. isopropamide, and neomycin. (2) Indications for use. For the control (a) Specifications. Each capsule con- of convulsions associated with idio- tains either: pathic epilepsy, epileptiform convul- (1) Capsule No. 1: 3.33 milligrams of sions, viral encephalitis, distemper, prochlorperazine (as the dimaleate), and hardpad disease that occurs as a 1.67 milligrams of isopropamide (as the clinically recognizable lesion in certain iodide), and 25 milligrams of neomycin entities in dogs. base (as the sulfate); or (3) Limitations. Federal law restricts (2) Capsule No. 3: 10 milligrams of this drug to use by or on the order of a prochlorperazine (as the dimaleate), 5 licensed veterinarian. milligrams of isopropamide (as the io- [42 FR 61594, Dec. 6, 1977, as amended at 43 dide), and 75 milligrams of neomycin FR 55386, Nov. 28, 1978; 46 FR 8467, Jan. 27, base (as the sulfate). 1981; 46 FR 57477, Nov. 24, 1981; 53 FR 40727, (b) Sponsor. See No. 054771 in Oct. 18, 1988; 56 FR 37473, Aug. 7, 1991; 62 FR § 510.600(c) of this chapter. 35076, June 30, 1997; 78 FR 21060, Apr. 9, 2013; (c) Conditions of use in dogs—(1) 79 FR 28827, May 20, 2014; 83 FR 48946, Sept. Amount. Administer capsules orally 28, 2018] twice daily to dogs as follows:

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Number of cap- (3) Limitations. Federal law restricts sules per dose this drug to use by or on the order of a Animal weight (pounds) Capsule Capsule licensed veterinarian. No. 1 No. 3 [79 FR 28827, May 20, 2014] 10 to 20 ...... 1 20 to 30 ...... 2 § 520.2041 Pyrantel pamoate chewable Over 30 ...... 3 1 Over 60 ...... 2 tablets. (a) Specifications. Each tablet con- (2) Indications for use. For the treat- tains pyrantel pamoate equivalent to ment infectious bacterial 22.7 or 113.5 milligrams pyrantel base. gastroenteritis associated with emo- (b) Sponsor. See Nos. 017135 and 051311 tional stress. in § 510.600(c) of this chapter. (3) Limitations. Federal law restricts (c) Conditions of use—(1) Amount. Pro- this drug to use by or on the order of a vides at least 2.27 milligrams pyrantel licensed veterinarian. base per pound body weight for dogs weighing more than 5 pounds, and at [49 FR 14103, Apr. 10, 1984, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, least 4.54 milligrams of pyrantel base 1995; 79 FR 28827, May 20, 2014] per pound body weight for dogs weighing 5 pounds or less. § 520.1962 Promazine. (2) Indications for use—(i) In dogs and (a) Specifications. Conforms to N.F. puppies. For removal of ascarids XII for promazine hydrochloride. (Toxocara canis; Toxascaris leonina) and (b) Sponsor. See No. 054771 in hookworms (Ancylostoma caninum; § 510.600(c) of this chapter. Uncinaria stenocephala). (c) Conditions of use in horses—(1) (ii) In puppies and adult dogs and in Amount. Administer 0.45 to 0.9 milli- lactating bitches after whelping. To grams per pound of body weight mixed prevent reinfection of Toxocara canis. with an amount of feed that will be (3) Limitations. Administer to puppies at 2, 3, 4, 6, 8, and 10 weeks of age. Ad- readily consumed. minister to lactating bitches 2 to 3 (2) Indications for use. For quieting weeks after whelping. Retreatment of excitable, unruly, or intractable adult dogs may be necessary at month- horses. ly intervals as determined by labora- (3) Limitations. Do not use in horses tory fecal examinations. Consult your intended for human consumption. Fed- veterinarian for assistance in the diag- eral law restricts this drug to use by or nosis, treatment, and control of para- on the order of a licensed veterinarian. sitism. [79 FR 28827, May 20, 2014] [52 FR 37937, Oct. 13, 1987, as amended at 57 § 520.2002 Propiopromazine. FR 48163, Oct. 22, 1992; 58 FR 44611, Aug. 24, 1993; 66 FR 9650, Feb. 9, 2001; 67 FR 21996, May (a) Specifications. Each chewable tab- 2, 2002; 81 FR 22523, Apr. 18, 2016; 82 FR 12169, let contains 10 or 20 milligrams of Mar. 1, 2017; 84 FR 8973, Mar. 13, 2019] propiopromazine hydrochloride. (b) Sponsor. See No. 054771 in § 520.2042 Pyrantel pamoate tablets. § 510.600(c) of this chapter. (a) Specifications. Each tablet con- (c) Conditions of use in dogs—(1) tains pyrantel pamoate equivalent to Amount. Administer 0.5 to 2.0 milli- 22.7, 45.4, or 113.5 milligrams of grams per pound of body weight once pyrantel base. or twice daily, depending upon the de- (b) Sponsor. See No. 017135 in gree of tranquilization desired. § 510.600(c) of this chapter. (2) Indications for use. For oral admin- (c) Conditions of use. It is used for istration as a tranquilizer. As an aid in dogs as follows: handling difficult, excited, and unruly (1) Amount. For dogs weighing over 5 dogs, and in controlling excessive ken- pounds, use at least 2.27 milligrams of nel barking, car sickness, and severe pyrantel base per pound of body dermatitis. It is also indicated for use weight; for dogs weighing 5 pounds or in minor surgery and prior to routine less, use at least 4.54 milligrams of examinations, laboratory procedures, pyrantel base per pound of body and diagnostic procedures. weight.

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

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(b) Sponsors. See sponsors in edentatus, S. equinus), small strongyles § 510.600(c) of this chapter. (Trichonema spp., Triodontophorus), (1) No. 054771 for use of product de- pinworms (Oxyuris), and large scribed in paragraph (a)(1) of this sec- roundworms (Parascaris). tion as in paragraph (d)(1)(i) and (d)(2) (iii) Limitations. Do not treat severely of this section. debilitated animals with this drug. Do (2) No. 017135 for use of product de- not use in horses intended for human scribed in paragraph (a)(2) of this sec- consumption. tion as in paragraph (d) of this section. (2) Swine—(i) Amount. Add to feed at (3) No. 061133 for use of product de- 0.4 gram pyrantel tartrate per pound of scribed in paragraph (a)(3) of this section as in paragraph (d)(1)(i) and (d)(2) non-pelleted ration. The ration is ad- of this section. ministered as a single treatment as the (c) Special considerations. See § 500.25 sole ration at the rate of 1 pound per 40 of this chapter. pounds of animal weight for animals up (d) Conditions of use. It is used in to 200 pounds. Animals 200 pounds and horses and ponies as follows: over are administered 5 pounds of ra- (1) Amounts and indications for use—(i) tion per animal. 3 mg per pound (/lb) body weight as sin- (ii) Indications for use. For the re- gle oral dose for removal and control of moval and control of large roundworms infections from the following mature (Ascaris suum) and nodular worm parasites: large strongyles (Strongylus (Oesophagostomum) infections. vulgaris, S. edentatus, S. equinus); small (iii) Limitations. Consult veterinarian strongyles; pinworms (Oxyuris equi); before using in severely debilitated and large roundworms (Parascaris animals. Do not treat within 24 hours equorum). of slaughter. (ii) 6 mg/lb body weight as single oral dose for the removal and control of ma- [79 FR 28827, May 20, 2014] ture infections of tapeworms (Anoplocephala perfoliata). § 520.2046 Pyrantel tartrate pellets. (2) Limitations. Do not use in horses (a) Specifications. (1) Each gram of intended for human consumption. pellets contains 12.5 milligrams (mg) [70 FR 29447, May 23, 2005, as amended at 76 (1.25 percent) pyrantel tartrate; or FR 17337, Mar. 29, 2011; 78 FR 17596, Mar. 22, (2) Each gram of pellets contains 21.1 2013; 79 FR 28827, May 20, 2014; 81 FR 17607, mg (2.11 percent) pyrantel tartrate. Mar. 30, 2016; 84 FR 8973, Mar. 13, 2019] (b) Sponsors. See sponsor numbers in § 520.2045 Pyrantel tartrate powder. § 510.600(c) of this chapter: (1) No. 054771 for use of products de- (a) Specifications. Each gram of pow- scribed in paragraph (a) as in para- der contains 106 milligrams (10.6 per- graph (c) of this section. cent) or 113 milligrams (11.3 percent) pyrantel tartrate. (2) No. 061133 for use of product de- (b) Sponsor. See No. 054771 in scribed in paragraph (a)(1) as in para- § 510.600(c) of this chapter for use of 11.3 graph (c) of this section. percent powder as in paragraph (d)(1) (c) Conditions of use in horses—(1) and 10.6 percent powder as in paragraph Amount. Administer as a single dose at (d)(2) and of this section. 12.5 mg per 2.2 pounds of body weight (c) Related tolerances. See § 556.560 of mixed with the usual grain ration. this chapter. (2) Indications for use. For the re- (d) Conditions of use—(1) Horses—(i) moval and control of infections from Amount. Administer as a single dose at the following mature parasites: Large 0.57 gram of pyrantel tartrate per 100 strongyles (Strongylus vulgaris, S. pounds of body weight mixed with the edentatus, S. equinus), small strongyles usual grain ration. Do not administer (Trichonema spp., Triodontophorus), by stomach tube or dose syringe. pinworms (Oxyuris), and large (ii) Indications for use. For the re- roundworms (Parascaris). moval and control of infections from (3) Limitations. Do not treat severely the following mature parasites: Large debilitated animals with this drug. Do strongyles (Strongylus vulgaris, S.

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not use in horses intended for human Coast tick), Dermacentor variabilis consumption. (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus [79 FR 28828, May 20, 2014, as amended at 84 FR 8973, Mar. 13, 2019] sanguineus (brown dog tick)] for 1 month in dogs 6 months of age or older § 520.2075 Robenacoxib. and weighing 2.8 pounds or greater. (a) Specifications. Each tablet con- (3) Limitations. Federal law restricts tains 10, 20, or 40 milligrams (mg) this drug to use by or on the order of a robenacoxib for use in dogs, or 6 mg licensed veterinarian. robenacoxib for use in cats. [81 FR 22523, Apr. 18, 2016, as amended at 82 (b) Sponsors. See No. 058198 in FR 12169, Mar. 1, 2017] § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) § 520.2098 Selegiline. Amount. Administer 0.91 mg/lb (2 mg/ (a) Specifications. Each tablet con- kg) orally, once daily, for a maximum tains 2, 5, 10, 15, or 30 milligrams (mg) of 3 days. selegiline hydrochloride. (ii) Indications for use. For the control (b) Sponsor. See No. 054771 in of postoperative pain and inflamma- § 510.600(c) of this chapter. tion associated with soft tissue surgery (c) Conditions of use in dogs—(1) in dogs weighing at least 5.5 lb (2.5 kg) Amounts and indications for use. (i) Ad- and at least 4 months of age for a max- minister 1 mg per kilogram (0.45 mg imum of 3 days. per pound) of body weight once daily (iii) Limitations. Federal law restricts for control of clinical signs associated this drug to use by or on the order of a with uncomplicated pituitary-depend- licensed veterinarian. ent hyperadrenocorticism in dogs. (2) Cats—(i) Amount. Administer 0.45 (ii) Administer 0.5 to 1.0 mg per kilo- mg/lb (1 mg/kg) orally, once daily, for a gram of body weight once daily for the maximum of 3 days. control of clinical signs associated (ii) Indications for use. For the control with canine cognitive dysfunction syn- of postoperative pain and inflamma- drome. tion associated with orthopedic sur- (2) Limitations. Federal law restricts gery, ovariohysterectomy, and castra- this drug to use by or on the order of a tion in cats weighing at least 5.5 lb (2.5 licensed veterinarian. kg) and at least 4 months of age for a maximum of 3 days. [79 FR 28828, May 20, 2014] (iii) Limitations. Federal law restricts this drug to use by or on the order of a § 520.2100 Selenium and vitamin E. licensed veterinarian. (a) Specifications. Each capsule con- [76 FR 18648, Apr. 5, 2011, as amended at 79 tains: FR 10964, Feb. 27, 2014; 81 FR 59133, Aug. 29, (1) 2.19 milligrams (mg) sodium sele- 2016] nite (equivalent to 1 mg selenium) and 56.2 mg (68 I.U.) vitamin E as d-alpha § 520.2086 Sarolaner. tocopheryl acid succinate; or (a) Specifications. Each chewable tab- (2) 0.548 mg sodium selenite (equiva- let contains 5, 10, 20, 40, 80, or 120 milli- lent to 0.25 mg selenium) and 14 mg (17 grams (mg) sarolaner. I.U.) vitamin E as d-alpha tocopheryl (b) Sponsor. See No. 054771 in acid succinate. § 510.600(c) of this chapter. (b) Sponsor. See No. 000061 in (c) Conditions of use in dogs—(1) § 510.600(c) of this chapter. Amount. Administer orally once a (c) Conditions of use in dogs—(1) month at the recommended minimum Amount. (i) Dogs over 20 pounds: Ad- dosage of 0.9 mg/lb (2 mg/kg). minister 1 capsule described in para- (2) Indications for use. Kills adult graph (a)(1) per 20 pounds of body fleas, and for the treatment and pre- weight to a maximum of 5 capsules. Re- vention of flea infestations peat at 3 day intervals until a satisfac- (Ctenocephalides felis), and the treat- tory therapeutic response is observed. ment and control of tick infestations Maintenance dosage is 1 capsule per 40 [Amblyomma americanum (lone star pounds of body weight every 3 to 7 tick), Amblyomma maculatum (Gulf days, or longer, as required.

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(ii) Dogs under 20 pounds: Administer gallon of water as the only source of 1 capsule described in paragraph (a)(2) drinking water for the first 3 to 5 days per 5 pounds of body weight with a of life. minimum of 1 capsule. Repeat at 3-day (ii) As an aid in the prevention or intervals until a satisfactory response control of losses due to CRD associated is observed. Maintenance dosage is 1 with M. gallisepticum (PPLO) in grow- capsule per 10 pounds of body weight ing chickens, administer 2 g per gallon every 3 to 7 days, or longer, as re- of water as the only source of drinking quired. water for the first 3 days of life and for (2) Indications for use. As an aid in al- 1 day following each vaccination. leviating and controlling inflamma- (2) Limitations. Do not administer to tion, pain, and lameness associated laying chickens. Do not administer with certain arthropathies. within 5 days of slaughter. 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. [73 FR 6607, Feb. 5, 2008, as amended at 81 FR [79 FR 28828, May 20, 2014] 94990, Dec. 27, 2016; 84 FR 8973, Mar. 13, 2019]

§ 520.2123 Spectinomycin oral dosage § 520.2123c Spectinomycin solution. forms. (a) Specifications. Each milliliter of § 520.2123a Spectinomycin tablets. solution contains spectinomycin (a) Specifications. Each tablet con- dihydrochloride pentahydrate equiva- tains spectinomycin dihydrochloride lent to 50 milligrams (mg) equivalent to 100 milligrams (mg) spectinomycin. spectinomycin. (b) Sponsors. See Nos. 016592, 054771, (b) Sponsors. See Nos. 054771 and and 061133 in § 510.600(c) of this chapter. 061133 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.600 of (c) Conditions of use in dogs—(1) this chapter. Amount. Administer orally to provide (d) Conditions of use in swine—(1) 10 mg per pound (lb) of body weight Amount. Administer 5 mg per pound (lb) twice daily. Dosage may be continued of body weight orally twice daily for 3 for 4 consecutive days. to 5 days. (2) Indications for use. For the treat- (2) Indications for use. For the treatment of infectious diarrhea and ment and control of porcine enteric gastroenteritis caused by organisms colibacillosis (scours) caused by E. coli susceptible to spectinomycin. susceptible to spectinomycin in pigs (3) Limitations. Federal law restricts under 4 weeks of age. this drug to use by or on the order of a (3) Limitations. Do not administer to licensed veterinarian. pigs over 15 lb body weight or over 4 weeks of age. Do not administer within [73 FR 6607, Feb. 5, 2008, as amended at 79 FR 28828, May 20, 2014; 84 FR 8973, Mar. 13, 2019] 21 days of slaughter. [73 FR 6607, Feb. 5, 2008, as amended at 78 FR § 520.2123b Spectinomycin powder. 17596, Mar. 22, 2013; 79 FR 28828, May 20, 2014; (a) Specifications. Each gram (g) of 81 FR 22523, Apr. 18, 2016; 84 FR 8973, Mar. 13, powder contains spectinomycin 2019] dihydrochloride pentahydrate equivalent to 0.5 g spectinomycin. § 520.2130 Spinosad. (b) Sponsor. See No. 061133 in (a) Specifications. Each chewable tab- § 510.600(c) of this chapter. let contains 90, 140, 270, 560, 810, or 1620 (c) Related tolerances. See § 556.600 of milligrams (mg) spinosad. this chapter. (b) Sponsor. See No. 058198 in § 510.600 (d) Conditions of use in chickens. It is of this chapter. administered in the drinking water of (c) Special considerations. Federal law growing chickens as follows: restricts this drug to use by or on the (1) Indications for use and amounts—(i) order of a licensed veterinarian. As an aid in controlling infectious syn- (d) Conditions of use—(1) Dogs—(i) ovitis due to Mycoplasma synoviae in Amount. Administer tablets once a broiler chickens, administer 1 g per month at a recommended minimum

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dosage of 13.5 mg per pound (30 mg per § 520.2150 Stanozolol. kilogram) of body weight. (a) Specifications. Each tablet or (ii) Indications for use. To kill fleas chewable tablet contains 2 milligrams and for the prevention and treatment stanozolol. of flea infestations (Ctenocephalides (b) Sponsor. No. 054771 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 in dogs and cats— pounds of body weight or greater. (1) Amount—(i) Dogs: Administered (2) Cats—(i) Amount. Administer tab- orally to small breeds, 1⁄2 to 1 tablet lets once a month at a minimum dos- twice daily for several weeks; to large age of 22.5 mg per pound (50 mg per breeds, 1 to 2 tablets twice daily for kilogram) of body weight. several weeks. The tablets may be (ii) Indications for use. To kill fleas crushed and administered in feed. and for the prevention and treatment (ii) Cats: Administered orally 1⁄2 to 1 of flea infestations (C. felis) for 1 month tablet twice daily for several weeks. on cats and kittens 14 weeks of age and (2) Indications for use. As an anabolic older and 2 pounds of body weight or steroid treatment. greater. (3) Limitations. Federal law restricts this drug to use by or on the order of a [77 FR 60623, Oct. 4, 2012, as amended at 81 FR licensed veterinarian. 48702, July 26, 2016] [79 FR 28828, May 20, 2014] § 520.2134 Spinosad and milbemycin. (a) Specifications. Each chewable tab- § 520.2158 Streptomycin. let contains 140 milligrams (mg) (a) Specifications. Each milliliter of spinosad and 2.3 mg milbemycin oxime, solution contains 250 milligrams (25 270 mg spinosad and 4.5 mg milbemycin percent) streptomycin sulfate. oxime, 560 mg spinosad and 9.3 mg (b) Sponsor. See No. 016592 in milbemycin oxime, 810 mg spinosad § 510.600(c) of this chapter. and 13.5 mg milbemycin oxime, or 1,620 (c) Related tolerances. See § 556.610 of mg spinosad and 27 mg milbemycin this chapter. oxime. (d) Conditions of use. Use in drinking (b) Sponsor. See No. 058198 in § 510.600 water as follows: of this chapter. (1) Calves—(i) Amount. 10 to 15 milli- (c) Conditions of use in dogs—(1) grams per pound (mg/pound) of body Amount. Administer once a month at a weight (1.0 to 1.5 grams per gallon) for minimum dosage of 13.5 mg/pound (lb) up to 5 days. (30 mg/kilogram (kg)) of body weight (ii) Indications for use. For the treat- spinosad and 0.2 mg/lb (0.5 mg/kg) of ment of bacterial enteritis caused by body weight milbemycin oxime. Escherichia coli and Salmonella spp. susceptible to streptomycin. (2) Indications for use. To kill fleas; (iii) Limitations. Federal law restricts for the prevention and treatment of this drug to use by or on the order of a flea infestations (Ctenocephalides felis); licensed veterinarian. for the prevention of heartworm dis- (2) Swine—(i) Amount. 10 to 15 mg/ ease (Dirofilaria immitis); and for the pound of body weight (1.0 to 1.5 grams treatment and control of adult per gallon) for up to 4 days. hookworm (Ancylostoma caninum), (ii) Indications for use. For the treat- adult roundworm (Toxocara canis and ment of bacterial enteritis caused by Toxascaris leonina), and adult Escherichia coli and Salmonella spp. sus- whipworm (Trichuris vulpis) infections ceptible to streptomycin. in dogs and puppies 8 weeks of age or (iii) Limitations. Federal law restricts older and 5 lbs of body weight or great- this drug to use by or on the order of a er. licensed veterinarian. (3) Limitations. Federal law restricts (3) Chickens—(i) Amount. 10 to 15 mg/ this drug to use by or on the order of a pound of body weight (0.6 to 0.9 grams licensed veterinarian. per gallon) for up to 5 days. [76 FR 12563, Mar. 8, 2011, as amended at 81 (ii) Indications for use. For the treat- FR 48702, July 26, 2016] ment of nonspecific infectious enteritis

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caused by organisms susceptible to (1) Amount. Administer in drinking streptomycin. water as 0.03 percent solution for 3 (iii) Limitations. Withdraw 4 days be- days. fore slaughter. Do not administer to (2) Indications for use. For the treat- chickens producing eggs for human ment of coccidiosis. consumption. Federal law restricts this (3) Limitations. Withdraw 4 days prior drug to use by or on the order of a li- to slaughter. Do not use in chickens censed veterinarian. producing eggs for human consumption. Federal law restricts this drug to [57 FR 37327, Aug. 18, 1992, as amended at 58 use by or on the order of a licensed vet- FR 47211, Sept. 8, 1993; 63 FR 51821, Sept. 29, 1998. Redesignated and amended at 79 FR erinarian. 28828, May 20, 2014; 79 FR 74020, Dec. 15, 2014; [79 FR 28829, May 20, 2014, as amended at 81 80 FR 18776, Apr. 8, 2015; 80 FR 61296, Oct. 13, FR 94990, Dec. 27, 2016] 2015] § 520.2200 Sulfachlorpyridazine. § 520.2170 Sulfabromomethazine. (a) Specifications. (1) Sodium (a) Specifications. Each bolus contains sulfachlorpyridazine powder. 15 grams of sulfabromomethazine so- (2) Each bolus contains 2 grams dium. sulfachlorpyridazine. (b) Sponsor. See No. 000010 in (3) Each tablet contains 250 milli- § 510.600(c) of this chapter. grams (mg) sulfachlorpyridazine. (c) Related tolerance. See § 556.620 of (b) Sponsor. See No. 016592 in this chapter. § 510.600(c) of this chapter. (d) Conditions of use in cattle—(1) (c) Related tolerances. See § 556.630 of Amount. Administer 90 milligrams per this chapter. pound body weight orally. Repeat in 48 (d) Conditions of use. It is used as fol- hours if necessary lows: (2) Indications for use. Treatment of (1) Calves—(i) Amount. Administer 30 necrotic pododermatitis (foot rot) and to 45 mg sulfachlorpyridazine powder calf diphtheria caused by Fusobacterium per pound (/lb) of body weight per day necrophorum; colibacillosis (scours) in milk or milk replacer, or in a bolus, caused by Escherichia coli; bacterial in divided doses twice daily for 1 to 5 pneumonia and bovine respiratory dis- days. ease complex (shipping fever complex) (ii) Indications for use. For the treat- associated with Pasteurella spp.; acute ment of diarrhea caused or complicated metritis and acute mastitis caused by by Escherichia coli (colibacillosis). Streptococcus spp. (iii) Limitations. Treated ruminating (3) Limitations. Milk taken from ani- calves must not be slaughtered for food mals within 96 hours (8 milkings) of during treatment or for 7 days after latest treatment must not be used for the last treatment. A withdrawal pe- food. Do not administer within 18 days riod has not been established for this of slaughter. product in preruminating calves. Do not use in calves to be processed for [47 FR 30243, July 13, 1982, as amended at 62 veal. Federal law restricts this drug to FR 63270, Nov. 28, 1997; 79 FR 28829, May 20, use by or on the order of a licensed vet- 2014; 84 FR 39183, Aug. 9, 2019] erinarian. (2) Swine—(i) Amount. Administer 20 § 520.2184 Sulfachloropyrazine. to 35 mg/lb body weight per day, in di- (a) Specifications. Each gram of pow- vided doses twice daily for 1 to 5 days: der contains 476 milligrams of sodium (A) In drinking water or sulfachloropyrazine monohydrate. (B) For individual treatment, in an (b) Sponsor. See No. 054771 in oral suspension containing 50 mg per § 510.600(c) of this chapter. milliliter. (c) Related tolerance. See § 556.625 of (ii) Indications for use. For the treat- this chapter. ment of diarrhea caused or complicated (d) Conditions of use in chickens. It is by E. coli (colibacillosis). used in the drinking water of broilers, (iii) Limitations. Treated swine must breeder flocks, and replacement chick- not be slaughtered for food during ens as follows: treatment or for 4 days after the last

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treatment. Federal law restricts this an aid in the control of coccidiosis drug to use by or on the order of a li- caused by Eimeria tenella and E. necatrix censed veterinarian. susceptible to sulfamerazine, (3) Dogs—(i) Amount. Administer tab- sulfamethazine, and sulfaquinoxaline: lets orally at 500 mg per 10 to 15 lb of Provide medicated water (0.04 percent body weight daily, in two or three di- solution) for 2 to 3 days, then plain vided doses. water for 3 days, then medicated water (ii) Indications for use. As an aid in (0.025 percent solution) for 2 days. If the treatment of infectious bloody droppings appear, repeat at 0.025 tracheobronchitis and infections percent level for 2 more days. Do not caused by E. coli, and in the treatment change litter. of infections caused by other Gram- positive and Gram-negative organisms (B) As an aid in the control of acute that are susceptible to sulfonamide fowl cholera caused by Pasteurella therapy. multocida susceptible to sulfamerazine, (iii) Limitations. Federal law restricts sulfamethazine, and sulfaquinoxaline: this drug to use by or on the order of a Provide medicated water (0.04 percent licensed veterinarian. solution) for 2 to 3 days. If disease recurs, repeat treatment. [75 FR 10166, Mar. 5, 2010, as amended at 79 FR 28829, May 20, 2014; 81 FR 17607, Mar. 30, (ii) Limitations. Do not treat chickens 2016; 81 FR 94990, Dec. 27, 2016] within 14 days of slaughter for food. Do not medicate chickens producing eggs § 520.2215 Sulfadiazine/pyrimethamine for human consumption. Federal law suspension. restricts this drug to use by or on the (a) Specifications. Each milliliter order of a licensed veterinarian. (mL) of suspension contains 250 milli- (2) Turkeys—(i) Amounts and indica- grams (mg) sulfadiazine (as the sodium tions for use—(A) As an aid in the con- salt) and 12.5 mg pyrimethamine. trol of coccidiosis caused by Eimeria (b) Sponsor. See No. 055246 in meleagrimitis and E. adenoeides suscep- § 510.600(c) of this chapter. tible to sulfamerazine, sulfamethazine, (c) Conditions of use in horses—(1) and sulfaquinoxaline: Provide medi- Amount. Administer orally 20 mg sulfa- cated water (0.025 percent solution) for diazine per kilogram (kg) body weight 2 days, then plain water for 3 days, and 1 mg/kg pyrimethamine daily. then medicated water (0.025 percent so- (2) Indications for use. For the treatment of equine protozoal lution) for 2 days, then plain water for myeloencephalitis (EPM) caused by 3 days, then medicated water (0.025 per- Sarcocystis neurona. cent solution) for 2 days. Repeat if nec- (3) Limitations. Do not use in horses essary. Do not change litter. intended for human consumption. Fed- (B) As an aid in the control of acute eral law restricts this drug to use by or fowl cholera caused by Pasteurella on the order of a licensed veterinarian. multocida susceptible to sulfamerazine, sulfamethazine, and sulfaquinoxaline: [69 FR 70054, Dec. 2, 2004, as amended at 73 FR 53686, Sept. 17, 2008; 75 FR 69586, Nov. 15, Provide medicated water (0.04 percent 2010] solution) for 2 to 3 days. If disease recurs, repeat treatment. § 520.2218 Sulfamerazine, (ii) Limitations. Do not treat turkeys sulfamethazine, and within 14 days of slaughter for food. Do sulfaquinoxaline powder. not medicate turkeys producing eggs (a) Specifications. Each 195-gram (g) for human consumption. Federal law packet of powder contains 78 g sulfa- restricts this drug to use by or on the merazine, 78 g sulfamethazine, and 39 g order of a licensed veterinarian. sulfaquinoxaline. (b) Sponsor. See No. 016592 in [71 FR 13001, Mar. 14, 2006, as amended at 79 § 510.600(c) of this chapter. FR 28829, May 20, 2014; 80 FR 34278, June 16, (c) Related tolerances. See §§ 556.660, 2015; 81 FR 22523, Apr. 18, 2016; 81 FR 94990, 556.670, and 556.685 of this chapter. Dec. 27, 2016; 85 FR 18119, Apr. 1, 2020] (d) Conditions of use—(1) Chickens—(i) Amounts and indications for use—(A) As

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§ 520.2220 Sulfadimethoxine oral dos- with Pasteurella spp. sensitive to age forms. sulfadimethoxine; and calf diphtheria and foot rot associated with § 520.2220a Sulfadimethoxine oral so- Fusobacterium necrophorum lution and soluble powder. (Sphaerophorus necrophorus) sensitive (a) Specifications. (1) Each ounce of to sulfadimethoxine. solution contains 3.75 grams (12.5 per- (iii) Limitations. Withdraw 7 days be- cent) sulfadimethoxine. fore slaughter. A withdrawal period has (2) Each 107 grams of powder contains not been established for this product in the equivalent of 94.6 grams preruminating calves. Do not use in sulfadimethoxine as sulfadimethoxine calves to be processed for veal. Federal sodium. law restricts this drug to use by or on (b) Sponsors. See sponsor numbers in the order of a licensed veterinarian. § 510.600(c) of this chapter: Federal law prohibits the extralabel (1) Nos. 016592, 054771, 054925, and use of this product in lactating dairy 069043 for use of the product described cattle. in paragraph (a)(1) of this section. [79 FR 28829, May 20, 2014, as amended at 81 (2) Nos. 016592, 054771, 054925, 058829, FR 22523, Apr. 18, 2016; 81 FR 94990, Dec. 27, 061133, and 066104 for use of the product 2016; 83 FR 48946, Sept. 28, 2018; 84 FR 8973, described in paragraph (a)(2) of this Mar. 13, 2019] section. (c) Related tolerances. See § 556.640 of § 520.2220b Sulfadimethoxine suspen- this chapter. sion. (d) Conditions of use—(1) Broiler and (a) Specifications. Each milliliter of replacement chickens—(i) Amount. Ad- suspension contains 50 milligrams (mg) minister 1.875 grams per gallon (0.05 sulfadimethoxine. percent) of drinking water for 6 con- (b) Sponsors. See Nos. 000061 and secutive days. 054771 in § 510.600(c) of this chapter. (ii) Indications for use. For treatment (c) Conditions of use in dogs and cats— of outbreaks of coccidiosis, fowl chol- (1) Amount. Administer orally 25 mg per era, and infectious coryza. pound of body weight, followed by 12.5 (iii) Limitations. Withdraw 5 days be- mg per pound of body weight daily. fore slaughter. Federal law restricts (2) Indications for use. For the treat- this drug to use by or on the order of a ment of sulfonamide susceptible bac- licensed veterinarian. terial infections in dogs and cats and (2) Turkeys—(i) Amount. Administer enteritis associated with coccidiosis in 0.938 grams per gallon (0.025 percent) of dogs. drinking water for 6 consecutive days. (3) Limitations. Federal law restricts (ii) Indications for use. Growing tur- this drug to use by or on the order of a keys: For treatment of disease out- licensed veterinarian. breaks of coccidiosis and fowl cholera. [79 FR 28829, May 20, 2014] (iii) Limitations. Withdraw 5 days before slaughter. Federal law restricts § 520.2220c Sulfadimethoxine tablet. this drug to use by or on the order of a (a) Specifications. Each tablet con- licensed veterinarian. tains 125, 250, or 500 milligrams (mg) (3) Cattle—(i) Amount. 1.18 to 2.36 sulfadimethoxine. grams per gallon (0.031 to 0.062 percent) (b) Sponsors. See Nos. 000061 and of drinking water. As a drench, admin- 054771 in § 510.600(c) of this chapter. ister 2.5 grams per 100 pounds of body (c) [Reserved] weight for first day, then 1.25 grams (d) Conditions of use in dogs and cats— per 100 pounds of body weight per day (1) Amount. Administer 25 milligrams for the next 4 consecutive days. If no (mg) per pound of body weight on the improvement within 2 to 3 days, re- first day followed by 12.5 milligrams evaluate diagnosis. Do not treat be- (mg) per pound of body weight per day yond 5 days. until the animal is free of symptoms (ii) Indications for use. Dairy calves, for 48 hours. dairy heifers, and beef cattle: For the (2) Indications for use. Treatment of treatment of shipping fever complex sulfadimethoxine-susceptible bacterial and bacterial pneumonia associated infections.

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(3) Limitations. Federal law restricts Fusobacterium necrophorum sensitive to this drug to use by or on the order of a sulfadimethoxine. licensed veterinarian. (3) Limitations. Do not use in female [79 FR 28829, May 20, 2014] dairy cattle 20 months of age or older. Do not administer within 12 days of § 520.2220d Sulfadimethoxine bolus. slaughter. Federal law restricts this (a) Specifications. Each bolus contains drug to use by or on the order of a li- 2.5, 5, or 15 grams sulfadimethoxine. censed veterinarian. (b) Sponsor. See No. 054771 in [79 FR 28830, May 20, 2014] § 510.600(c) of this chapter. (c) Related tolerances. See § 556.640 of § 520.2220f Sulfadimethoxine and this chapter. ormetoprim tablet. (d) Conditions of use in cattle—(1) (a) Specifications. Each tablet con- Amount. Administer 2.5 grams per 100 tains 120 milligrams (mg) (100 mg pounds body weight for 1 day followed sulfadimethoxine and 20 mg by 1.25 grams per 100 pounds body ormetoprim), 240 mg (200 mg weight per day; treat for 4 to 5 days. sulfadimethoxine and 40 mg (2) Indications for use. For the treat- ormetoprim), 600 mg (500 mg ment of shipping fever complex and sulfadimethoxine and 100 mg bacterial pneumonia associated with ormetoprim), or 1200 mg (1000 mg Pasteurella spp. sensitive to sulfadimethoxine and 200 mg sulfadimethoxine; and calf diphtheria ormetoprim). and foot rot associated with (b) Sponsor. See No. 054771 in Fusobacterium necrophorum sensitive to § 510.600(c) of this chapter. sulfadimethoxine. (c) Conditions of use in dogs—(1) (3) Limitations. Do not administer Amount. On the first day of treatment, within 7 days of slaughter; milk that administer 25 mg per pound (55 mg per has been taken from animals during kilogram) of body weight. Then follow treatment and 60 hours (5 milkings) with a daily dosage of 12.5 mg per after the latest treatment must not be pound (27.5 mg per kilogram) of body used for food. A withdrawal period has weight. Do not exceed a total of 21 con- not been established for this product in secutive days. preruminating calves. Do not use in calves to be processed for veal. (2) Indications of use. Treatment of skin and soft tissue infections (wounds [79 FR 28829, May 20, 2014] and abscesses) in dogs caused by strains of Staphylococcus aureus and § 520.2220e Sulfadimethoxine ex- Escherichia coli and urinary tract infec- tended-release bolus. tions caused by E. coli, Staphylococcus (a) Specifications. Each extended-re- spp., and Proteus mirabilus susceptible lease bolus contains 12.5 grams to ormetoprim-potentiated sulfadimethoxine. sulfadimethoxine. (b) Sponsor. See No. 054771 in (3) Limitations. Federal law restricts § 510.600(c) of this chapter. this drug to use by or on the order of a (c) Related tolerances. See § 556.640 of licensed veterinarian. this chapter. (d) Conditions of use in beef cattle and [79 FR 28830, May 20, 2014] non-lactating dairy cattle—(1) Amount. Administer one 12.5-gram-sustained-re- § 520.2240 Sulfaethoxypyridazine. lease bolus for the nearest 200 pounds of body weight, i.e., 62.5 milligrams per § 520.2240a Sulfaethoxypyridazine solution. pound of body weight. Do not repeat treatment for 7 days. (a) Specifications. Each milliliter of (2) Indications for use. For the treat- solution contains 62.5 milligrams (mg) ment of shipping fever complex and sodium sulfaethoxypyridazine. bacterial pneumonia associated with (b) Sponsor. See No. 054771 § 510.600(c) Pasteurella spp. sensitive to of this chapter. sulfadimethoxine; and calf diphtheria (c) Related tolerances. See § 556.650 of and foot rot associated with this chapter.

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(d) Conditions of use—(1) Swine—(i) been taken from animals during treat- Amount. Administer 3.8 grams per gal- ment and for 72 hours (6 milkings) after lon for first day followed by 1.9 grams latest treatment must not be used for per gallon for not less than 3 days nor food. Federal law restricts this drug to more than 9 days. Use as the sole use by or on the order of a licensed vet- source of sulfonamide. erinarian. (ii) Indications for use. For treatment (2) 15-gram extended-release tablets—(i) of bacterial scours pneumonia enter- Amount. Administer 100 milligrams per itis, bronchitis, septicemia accom- pound of body weight. Use as the sole panying Salmonella choleraesuis infec- source of sulfonamide. tion. (ii) Indications for use. For treatment (iii) Limitations. Do not treat within of foot rot and respiratory infections 10 days of slaughter. Federal law re- (shipping fever and pneumonia) caused stricts this drug to use by or on the by sulfonamide-susceptible pathogens order of a licensed veterinarian. (E. coli, Streptococci, Staphylococci, (2) Cattle—(i) Amount. For use at 2.5 Sphaerophorus necrophorus and Gram- grams per gallon. Administer at the negative rods including Pasteurella); rate of 1 gallon per 100 pounds of body and for use prophylactically during pe- weight per day for 4 days. Use as the riods of stress for reducing losses due sole source of sulfonamide. to sulfonamide sensitive disease condi- (ii) Indications for use. For treatment tions. of respiratory infections (pneumonia, (iii) Limitations. Do not treat within shipping fever), foot rot, calf scours; 16 days of slaughter. Not for use in lac- and as adjunctive therapy in septi- tating dairy cows. Federal law restricts cemia accompanying mastitis and me- this drug to use by or on the order of a tritis. licensed veterinarian. (iii) Limitations. Do not treat within 16 days of slaughter. Milk that has [79 FR 28830, May 20, 2014] been taken from animals during treat- § 520.2260 Sulfamethazine oral dosage ment and for 72 hours (6 milkings) after forms. latest treatment must not be used for food. Federal law restricts this drug to § 520.2260a Sulfamethazine oblet, tab- use by or on the order of a licensed vet- let, and bolus. erinarian. (a)(1) Sponsor. See No. 016592 in [79 FR 28830, May 20, 2014] § 510.600(c) of this chapter for use of 2.5- , 5-, and 15-gram sulfamethazine oblet § 520.2240b Sulfaethoxypyridazine tab- in beef cattle, nonlactating dairy cat- lets. tle, and horses. See No. 061690 in (a) Specifications—(1) Each tablet con- § 510.600(c) of this chapter for use of 5- tains 2.5 or 15 grams , 15-, and 25-gram tablet in beef and sulfaethoxypyridazine. nonlactating dairy cattle. (2) Each extended-release tablet con- (2) Related tolerance in edible products. tains 5 grams sulfaethoxypyridazine. See § 556.670 of this chapter. (b) Sponsor. See No. 054771 § 510.600(c) (3) Conditions of use—(i) Amount. Ad- of this chapter. minister as a single dose 100 milligrams (c) Related tolerances. See § 556.650 of of sulfamethazine per pound of body this chapter. weight the first day and 50 milligrams (d) Conditions of use in cattle—(1) 2.5- per pound of body weight on each fol- or 15-gram tablets—(i) Amount. Admin- lowing day. ister 25 milligrams per pound of body (ii) Indications for use. For treatment weight per day for 4 days. Use as the of diseases caused by organisms suscep- sole source of sulfonamide. tible to sulfamethazine. (ii) Indications for use. For treatment (A) Beef cattle and nonlactating dairy of respiratory infections (pneumonia, cattle. Treatment of bacterial pneu- shipping fever), foot rot, calf scours; as monia and bovine respiratory disease adjunctive therapy in septicemia ac- complex (shipping fever complex) companying mastitis and metritis. (Pasteurella spp.), colibacillosis (bac- (iii) Limitations. Do not treat within terial scours) (Escherichia coli), necrotic 16 days of slaughter. Milk that has 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 associated with Pasteurella spp.), strangles [54 FR 15751, Apr. 19, 1989; 54 FR 19283, May 4, (Streptococcus equi), and bacterial en- 1989, as amended at 56 FR 50653, Oct. 8, 1991; teritis (Escherichia coli). 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 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; 79 FR 28830, May 20, 2014; ance are normal. If symptoms persist 81 FR 17607, Mar. 30, 2016] after using for 2 or 3 days consult a veterinarian. Fluid intake must be ade- § 520.2260b Sulfamethazine sustained- quate. Treatment should continue 24 to release boluses. 48 hours beyond the remission of dis- (a) Related tolerances. See § 556.670 of ease symptoms, but not to exceed 5 this chapter. consecutive days. Follow dosages carefully. Do not treat cattle within 10 (b)(1) Sponsor. See No. 000859 in days of slaughter. Do not use in female § 510.600(c) of this chapter for use of a dairy cattle 20 months of age or older. 22.5-gram sulfamethazine prolonged-re- Use of sulfamethazine in this class of lease bolus. cattle may cause milk residues. A (2) Conditions of use—(i) Amount. De- withdrawal period has not been estab- pending on the duration of therapeutic lished in preruminating calves. Do not levels desired, administer boluses as a use in calves to be processed for veal. single dose as follows: 31⁄2 days—1 bolus Do not use in horses intended for (22.5 grams) per 200 pounds of body human consumption. weight; 5 days—1 bolus per 100 pounds (b)(1) Sponsor. See No. 054771 in of body weight. § 510.600(c) of this chapter for use of 5- (ii) Indications for use. Beef and non- gram sulfamethazine bolus. lactating cattle for sustained treat- (2) Related tolerances in edible prod- ment of shipping fever pneumonia ucts. See § 556.670 of this chapter. caused or complicated by Pasteurella (3) Conditions of use—(i) Amount. Ad- multocida; as an aid in the treatment of minister 10 grams (2 boluses) of foot rot, mastitis, pneumonia, metritis, sulfamethazine per 100 pounds of body bacterial enteritis, calf diphtheria, and weight the first day, then 5 grams (1 septicemia when caused or complicated bolus) of sulfamethazine per 100 pounds by bacteria susceptible to of body weight daily for up to 4 addi- sulfamethazine. tional consecutive days. (iii) Limitations. Cattle that are (ii) Indications for use. Ruminating acutely ill should be treated beef and dairy calves. For treatment of parenterally with a suitable anti- the following diseases caused by organisms susceptible to sulfamethazine: bacterial product to obtain immediate bacterial scours (colibacilloosis) caused therapeutic blood levels; do not slaugh- by E. coli; necrotic pododermatitis (foot ter animals for food within 16 days of rot) and calf diphtheria caused by F. treatment; do not use in lactating necrophorum; bacterial pneumonia asso- dairy cattle; Federal law restricts this ciated with Pasteurella spp.; and coc- drug to use by or on the order of a li- cidiosis caused by E. bovis and E. zurnii. censed veterinarian. (iii) Limitations. Do not administer (c)(1) Sponsor. See No. 054771 in for more than 5 consecutive days. Do § 510.600(c) of this chapter for use of a not treat calves within 11 days of 27-gram sulfamethazine sustained-re- slaughter. Do not use in calves to be lease bolus. slaughtered under 1 month of age or in (2) Conditions of use—(i) Amount. 27 calves being fed an all milk diet. Do grams (1 bolus) for each 150 pounds of not use in female dairy cattle 20 body weight as a single dose.

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(ii) Indications for use. For nonlac- may cause milk residues. Do not treat tating cattle for the treatment of in- animals within 12 days of slaughter. fections caused by organisms sensitive (e)(1) Sponsor. See 000859 in § 510.600(c) to sulfamethazine such as hemorrhagic of this chapter for use of a 22.5-gram septicemia (shipping fever complex), sulfamethazine sustained release bolus. bacterial pneumonia, foot rot, and calf (2) Conditions of use—(i) Amount. Ad- diphtheria and as an aid in the control minister 1 bolus (22.5 grams) per 200 of bacterial diseases usually associated pounds of body weight, as a single dose. with shipping and handling of cattle. (ii) Indications for use. Beef and non- (iii) Limitations. If no response within lactating dairy cattle for the prolonged 2 to 3 days, reevaluate therapy; do not treatment of the following diseases crush tablets; treated animals must when caused by one or more of the list- not be slaughtered for food within 28 ed pathogenic organisms sensitive to days after the latest treatment; Fed- sulfamethazine: bovine respiratory dis- eral law restricts this drug to use by or ease complex (shipping fever complex) on the order of a licensed veterinarian. (Pasteurella spp.), bacterial pneumonia (d)(1) Sponsor. See No. 061133 in (Pasteurella spp.), necrotic § 510.600(c) of this chapter for use of a pododermatitis (foot rot) 32.1-gram sustained-release bolus. (Fusobacterium necrophorum), colibacillosis (bacterial scours) (2) Conditions of use—(i) Amount. 32.1 (Escherichia coli), calf diphtheria grams (1 bolus) per 200 pounds of body (Fusobacterium necrophorum), acute weight. mastitis (Streptococcus spp.) and acute (ii) Indications for use. For beef and metritis (Streptococcus spp.). nonlactating dairy cattle for the treat- (iii) Limitations. Cattle that are ment of diseases caused by acutely ill should be treated by injec- sulfamethazine-sensitive organisms as tion with a suitable antibacterial prod- follows: bacterial pneumonia and bo- uct to obtain immediate therapeutic vine respiratory disease complex (ship- blood levels; do not slaughter animals ping fever complex) caused by for food within 16 days of treatment; do Pasteurella spp., colibacillosis (bac- not use in lactating dairy cattle; if terial scours) caused by E. coli, necrotic treated animals do not respond within pododermatitis (foot rot) and calf diph- 2 to 3 days, consult a veterinarian. theria caused by Fusobacterium (f)(1) Sponsor. See No. 061133 in necrophorum, and acute mastitis and § 510.600(c) of this chapter for use of an acute metritis caused by Streptococcus 8.02-gram sulfamethazine sustained-re- spp.) lease bolus. (iii) Limitations. After 72 hours, all (2) Conditions of use—(i) Amount. Ad- animals should be reexamined for per- minister 2 boluses (8.02 grams per sistence of observable disease signs. If bolus) per 100 pounds of body weight, as signs are present, consult a veteri- a single dose. narian. It is strongly recommended (ii) Indications for use. Administer that a second dose be given to provide orally to ruminating calves for the pro- for an additional 72 hours of therapy, longed treatment of the following dis- particularly in more severe cases. The eases when caused by one or more of dosage schedule should be used at each the listed pathogenic organisms sen- 72-hour interval. Animals should not sitive to sulfamethazine: bacterial receive more than 2 doses because of pneumonia (Pasteurella spp.), the possibility of incurring residue vio- colibacillosis (bacterial scours) (E. lations. This drug, like all coli), and calf diptheria (Fusobacterium sulfonamides, may cause toxic reac- necrophorum). tions and irreparable injury unless ad- (iii) Limitations. For use in rumi- ministered with adequate and contin- nating replacement calves only; 72 uous supervision; follow dosages care- hours after dosing all animals should fully. Fluid intake must be adequate at be reexamined for persistence of dis- all times throughout the 3-day ther- ease signs; if signs are present, consult apy, Do not use in female dairy cattle a veterinarian; do not slaughter ani- 20 months of age or older. Use of mals for food for at least 12 days after sulfamethazine in this class of cattle the last dose; this product has not been

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shown to be effective for nonrumi- spp.; colibacillosis (bacterial scours) nating calves; exceeding two consecu- caused by Escherichia coli; coccidiosis tive doses may cause violative tissue caused by Eimeria bovis and E. zurnii; residue to remain beyond the with- and calf diphtheria caused by drawal time; do not use in calves under Fusobacterium necrophorum. 1 month of age or calves being fed an (iii) Limitations. Do not use in calves all milk diet. to be slaughtered under 1 month of age (g)(1) Sponsor. See No. 016592 in or calves being fed an all milk diet. Do § 510.600(c) of this chapter for use of a not use in female dairy cattle 20 30-gram sulfamethazine sustained-re- months of age or older. If symptoms lease bolus. persist after 3 days, consult a veteri- (2) Conditions of use—(i) Amount. Ad- narian. Do not administer more than 2 minister at the rate of 1 bolus (30 grams per bolus) per 200 pounds of body consecutive doses. Do not slaughter weight, as a single dose. animals for food for at least 8 days (ii) Indications for use. Administer after the last dose. Do not crush bolus. orally to beef cattle and nonlactating [46 FR 36132, July 14, 1981, as amended at 48 dairy cattle for the treatment of the FR 18803, Apr. 26, 1983; 48 FR 32760, July 19, following diseases when caused by one 1983; 49 FR 29057, July 18, 1984; 50 FR 49372, or more of the listed pathogenic orga- Dec. 2, 1985; 51 FR 30212, Aug. 25, 1986; 53 FR nisms sensitive to sulfamethazine: bo- 40727, Oct. 18, 1988; 54 FR 14341, Apr. 11, 1989; vine respiratory disease complex (ship- 55 FR 8462, Mar. 8, 1990; 56 FR 50653, Oct. 8, ping fever complex) associated with 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. Pasteurella spp.; bacterial pneumonia 9, 1996; 62 FR 35076, June 30, 1997; 66 FR 14073, associated with Pasteurell spp.; necrotic Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 70 FR pododermatitis (foot rot) and calf diph- 8290, Feb. 18, 2005; 78 FR 17596, Mar. 22, 2013; theria caused by Fusobacterium 79 FR 28830, May 20, 2014; 81 FR 22523, Apr. 18, 2016; 84 FR 8973, Mar. 13, 2019; 85 FR 18119, necrophorum; colibacillosis (bacterial Apr. 1, 2020] scours) caused by Escherichia coli; coccidiosis caused by Eimeria bovis and E. § 520.2260c Sulfamethazine sustained- zurnii; acute mastitis and metritis release tablets. caused by Streptococcus spp. (iii) Limitations. For use in beef cattle (a) Specifications. Each extended-re- and nonlactating dairy cattle only; if lease tablet contains 8 grams symptoms persist for 2 or 3 days after sulfamethazine. use, consult a veterinarian; do not (b) Sponsor. See No. 054771 in slaughter animals for food for at least § 510.600(c) of this chapter. 8 days after the last dose; do not use in (c) Related tolerances. See § 556.670 of lactating dairy cattle; do not admin- this chapter. ister more than two consecutive doses. (d) Conditions of use—(1) Amount. 8 (h)(1) Sponsor. See No. 000010 in grams (1 tablet) per 45 pounds of body § 510.600(c) of this chapter for use of an weight as a single dose. 8.25-gram sulfamethazine sustained-re- (2) Indications for use. In calves for lease bolus. sustained treatment of pneumonia (2) Conditions of use—(i) Amount. Ad- caused by Pasteurella spp., minister at the rate of 1 bolus (8.25 colibacillosis (bacterial scours) caused grams per bolus) per 50 pounds of body by Escherichia coli; and calf diptheria weight, as a single dose. If signs of dis- caused by Fusobacterium necrophorum. ease are significantly reduced, it is rec- (3) Treated animals must ommended that a second dose be given Limitations. to provide an additional 72 hours of not be slaughtered for food within 18 therapy. days after the latest treatment. Fed- (ii) Indications for use. Administer eral law restricts this drug to use by or orally to ruminating beef and dairy on the order of a licensed veterinarian. calves for treatment of the following [48 FR 26763, June 10, 1983, as amended at 56 diseases when caused by one or more of FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; the listed pathogenic organisms sus- 61 FR 4875, Feb. 9, 1996; 79 FR 28830, May 20, ceptible to sulfamethazine: bacterial 2014] pneumonia associated with Pasteurella

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§ 520.2261 Sulfamethazine sodium oral graph (c) of this section, then reduce dosage forms. amount of medication to one-half for 4 additional days. § 520.2261a Sulfamethazine solution. (3) Limitations. Add the required dose (a) Specifications. Each milliliter of to that amount of water that will be solution contains 125 milligrams (12.5 consumed in 1 day. Consumption percent) sulfamethazine sodium. should be carefully checked. Have only (b) Sponsors. See No. 016592 in medicated water available during § 510.600(c) of this chapter. treatment. Withdraw medication from (c) Related tolerances. See § 556.670 of cattle, chickens, and turkeys 10 days this chapter. prior to slaughter for food. Withdraw (d) Conditions of use—(1) Amount. Ad- medication from swine 15 days before minister in drinking water to provide: slaughter for food. Do not medicate Cattle and swine 112.5 milligrams of chickens or turkeys producing eggs for sulfamethazine sodium per pound of human consumption. Treatment of all body weight per day on the first day diseases should be instituted early. and 56.25 milligrams per pound of body Treatment should continue 24 to 48 weight on subsequent days; Chickens, hours beyond the remission of disease 61 to 89 milligrams of sulfamethazine symptoms, but not to exceed a total of sodium per pound of body weight per 5 consecutive days in cattle or swine. day, and turkeys 53 to 130 milligrams Medicated cattle, swine, chickens, and of sulfamethazine sodium per pound of turkeys must actually consume enough body weight per day, depending upon medicated water which provides the the dosage, age, and class of chickens recommended dosages. Do not use in fe- or turkeys, ambient temperature, and male dairy cattle 20 months of age or other factors. older. Use of sulfamethazine in this (2) Indications for use. For treatment class of cattle may cause milk resi- and control of diseases caused by orga- dues. A withdrawal period has not been nisms sensitive to sulfamethazine. established in preruminating calves. (i) Beef and nonlactating dairy cattle. Do not use in calves to be processed for Treatment of bacterial pneumonia and veal. Federal law restricts this drug to bovine respiratory disease complex use by or on the order of a licensed vet- (shipping fever complex) (Pasteurella erinarian. spp.), colibacillosis (bacterial scours) [47 FR 25322, June 11, 1982, as amended at 47 (Escherichia coli), necrotic FR 25735, June 15, 1982; 67 FR 78355, Dec. 24, pododermatitis (foot rot) 2002; 70 FR 32489, June 3, 2005; 74 FR 36112, (Fusobacterium necrophorum), calf diph- July 22, 2009; 75 FR 10166, Mar. 5, 2010; 76 FR theria (Fusobacterium necrophorum), 17337, Mar. 29, 2011; 79 FR 28831, May 20, 2014; acute mastitis (Streptococcus spp.), and 81 FR 17607, Mar. 30, 2016; 81 FR 36789, June acute metritis (Streptococcus spp.). 8, 2016; 81 FR 94990, Dec. 27, 2016] (ii) Swine. Treatment of porcine colibacillosis (bacterial scours) § 520.2261b Sulfamethazine powder. (Escherichia coli), and bacterial pneu- (a) Specifications. A soluble powder monia (Pasteurella spp.). composed of 100 percent sulfamethazine (iii) Chickens and turkeys. In chickens sodium. for control of infectious coryza (b) Sponsors. See Nos. 016592 and (Avibacterium paragallinarum), coccidi- 061133 in § 510.600(c) of this chapter. osis (Eimeria tenella, Eimeria necatrix), (c) Related tolerances. See § 556.670 of acute fowl cholera (Pasteurella this chapter. multocida), and pullorum disease (d) Conditions of use—(1) Chickens—(i) (Salmonella Pullorum). In turkeys for Amount. Administer in drinking water control of coccidiosis (Eimeria to provide 58 to 85 milligrams (mg) per meleagrimitis, Eimeria adenoeides). Medi- pound (/lb) of body weight per day. cate as follows: Infectious coryza in (ii) Indications for use. For control of chickens, medicate for 2 consecutive infectious coryza (Avibacterium days; acute fowl cholera and pullorum paragallinarum), coccidiosis (Eimeria disease, in chickens, medicate for 6 tenella, E. necatrix), acute fowl cholera consecutive days; coccidiosis, in chick- (Pasteurella multocida), and pullorum ens and turkeys, medicate as in para- disease (Salmonella Pullorum).

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(iii) Limitations. Add the required ment of all diseases should be insti- dose to that amount of water that will tuted early. Treatment should con- be consumed in 1 day. Consumption tinue 24 to 48 hours beyond the remis- should be carefully checked. Have only sion of disease symptoms, but not to medicated water available during exceed a total of 5 consecutive days. treatment. Withdraw medication 10 Medicated swine must actually con- days prior to slaughter for food. Do not sume enough medicated water which medicate chickens producing eggs for provides the recommended dosages. human consumption. Treatment of all Federal law restricts this drug to use diseases should be instituted early. by or on the order of a licensed veteri- Treatment should continue 24 to 48 narian. hours beyond the remission of disease (4) Cattle—(i) Amount. Administer in symptoms. Medicated chickens must drinking water, or as a drench, to pro- actually consume enough medicated vide 108 mg/lb of body weight on the water which provides the recommended first day and 54 mg/lb of body weight dosages. Federal law restricts this drug per day on the second, third, and fourth to use by or on the order of a licensed days of administration. veterinarian. (ii) Indications for use in beef and non- (2) Turkeys—(i) Amount. Administer lactating dairy cattle. Treatment of bac- in drinking water to provide 50 to 124 terial pneumonia and bovine res- mg/lb of body weight per day piratory disease complex (shipping (ii) Indications for use. For control of fever complex) (Pasteurella spp.), coccidiosis (E. meleagrimitis, E. colibacillosis (bacterial scours) (E. adenoeides). coli), necrotic pododermatitis (foot rot) (iii) Limitations. Add the required (Fusobacterium necrophorum), calf diph- dose to that amount of water that will theria (F. necrophorum), acute mastitis be consumed in 1 day. Consumption (Streptococcus spp.), and acute metritis should be carefully checked. Have only (Streptococcus spp.) medicated water available during (iii) Limitations. Add the required treatment. Withdraw medication 10 dose to that amount of water that will days prior to slaughter for food. Do not be consumed in 1 day. Consumption medicate turkeys producing eggs for should be carefully checked. Have only human consumption. Treatment of all medicated water available during diseases should be instituted early. treatment. Withdraw medication 10 Treatment should continue 24 to 48 days prior to slaughter for food. Treat- hours beyond the remission of disease ment of all diseases should be insti- symptoms. Medicated turkeys must ac- tuted early. Treatment should con- tually consume enough medicated tinue 24 to 48 hours beyond the remis- water which provides the recommended sion of disease symptoms, but not to dosages. Federal law restricts this drug exceed a total of 5 consecutive days. to use by or on the order of a licensed Medicated cattle must actually con- veterinarian. sume enough medicated water which (3) Swine—(i) Amount. Administer in provides the recommended dosages. Do drinking water, or as a drench, to pro- not use in female dairy cattle 20 vide 108 mg/lb of body weight on the months of age or older. Use of first day and 54 mg/lb of body weight sulfamethazine in this class of cattle per day on the second, third, and fourth may cause milk residues. Do not use in days of administration. calves under one (1) month of age or (ii) Indications for use. For treatment calves being fed an all-milk diet. Use in of porcine colibacillosis (bacterial these classes of calves may cause viola- scours) (E. coli), and bacterial pneu- tive residues to remain beyond the monia (Pasteurella spp.). withdrawal time. Federal law restricts (iii) Limitations. Add the required this drug to use by or on the order of a dose to that amount of water that will licensed veterinarian. be consumed in 1 day. Consumption [71 FR 70303, Dec. 4, 2006, as amended at 75 should be carefully checked. Have only FR 10166, Mar. 5, 2010; 79 FR 28831, May 20, medicated water available during 2014; 80 FR 61296, Oct. 13, 2015; 81 FR 17607, treatment. Withdraw medication 15 Mar. 30, 2016; 81 FR 94990, Dec. 27, 2016; 84 FR days prior to slaughter for food. Treat- 8973, Mar. 13, 2019]

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§ 520.2280 Sulfamethizole and methe- (1) Chickens. (i) As an aid in the con- namine. trol of outbreaks of coccidiosis caused (a) Specifications. Each tablet con- by Eimeria tenella, E. necatrix, E. tains 250 milligrams of sulfamethizole acervulina, E. maxima, and E. brunetti. and 250 milligrams of methenamine (ii) Administer at the 0.04 percent mandelate. level for 2 or 3 days, skip 3 days then (b) Sponsor. See No. 054771 in administer at the 0.025 percent level for § 510.600(c) of this chapter. 2 more days. If bloody droppings ap- (c) Conditions of use in dogs and cats— pear, repeat treatment at the 0.025 per- (1) Amount. Administer orally 1 tablet cent level for 2 more days. Do not per 20 pounds of body weight 3 times change litter unless absolutely nec- per day until clinical signs are allevi- essary. Do not give flushing mashes. ated. To reduce the possibility of re- (2) Turkeys. (i) As an aid in the con- lapse, continue therapy for a week to trol of outbreaks of coccidiosis caused 10 days. by Eimeria meleagrimitis and E. (2) Indications for use. For treatment adenoeides. of urinary tract infections such as cys- (ii) Administer at the 0.025 percent titis, nephritis, prostatitis, urethritis, level for 2 days, skip 3 days, give for 2 and pyelonephritis. As an aid in the days, skip 3 days and give for 2 more management of complications result- days. Repeat if necessary. Do not ing from surgical manipulations of the change litter unless absolutely nec- urinary tract such as removal of essary. Do not give flushing mashes. calculi from the bladder, in (3) Chickens and turkeys. (i) As an aid ureterostomies, and in instrumenta- in the control of acute fowl cholera tion of the urethra and bladder. caused by Pasteurella multocida suscep- (3) Limitations. Federal law restricts tible to sulfaquinoxaline and fowl ty- this drug to use by or on the order of a phoid caused by Salmonella gallinarum licensed veterinarian. susceptible to sulfaquinoxaline. [40 FR 13838, Mar. 27, 1975, as amended at 50 (ii) Administer at the 0.04 percent FR 13561, Apr. 5, 1985; 79 FR 28831, May 20, level for 2 or 3 days. Move birds to 2014] clean ground. If disease recurs, repeat treatment. If cholera has become es- § 520.2325 Sulfaquinoxaline oral dos- tablished as the respiratory or chronic age forms. form, use feed medicated with § 520.2325a Sulfaquinoxaline powder sulfaquinoxaline. Poultry which have and solution. survived typhoid outbreaks should not (a) Sponsor. See § 510.600(c) of this be kept for laying house replacements chapter for identification of the spon- or breeders unless tests show they are sors. not carriers. (1) To No. 016592 for use of a 25-per- (4) Cattle and calves. (i) For the con- cent sulfaquinoxaline soluble powder trol and treatment of outbreaks of coc- and a 20-percent sulfaquinoxaline so- cidiosis caused by Eimeria bovis or E. dium solution as provided for in para- zurnii. graph (c) of this section. (ii) Administer at the 0.015-percent (2) To Nos. 016592 and 054771 for use of level for 3 to 5 days in drinking water a 31.92-percent sulfaquinoxaline solu- medicated with sulfaquinoxaline solution (sodium and potassium salts) as tion. provided for in paragraphs (c)(1), (c)(2), (iii) In lieu of treatment as provided (c)(3), (c)(4)(i), and (c)(4)(ii) of this sec- in paragraph (e)(4)(ii) of this section, tion. administer 1 teaspoon of 25-percent (3) No. 054771 for use of a 28.62-percent sulfaquinoxaline soluble powder per sulfaquinoxaline sodium solution as day for each 125 pounds of body weight provided in paragraphs (c)(1), (c)(2), and for 3 to 5 days in drinking water. (c)(3) of this section. (d) Limitations. May cause toxic reac- (b) Related tolerances. See § 556.685 of tions unless the drug is evenly mixed this chapter. in water at dosages indicated and used (c) Conditions of use. It is used in according to directions. For control of drinking water as follows: outbreaks of disease, medication

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should be initiated as soon as the diag- use by or on the order of a licensed vet- nosis is determined. Medicated chick- erinarian. ens, turkeys, cattle, and calves must [79 FR 28831, May 20, 2014, as amended at 82 actually consume enough medicated FR 12169, Mar. 1, 2017; 84 FR 32992, July 11, water which provides a recommended 2019; 84 FR 53310, Oct. 7, 2019] dosage of approximately 10 to 45 milligrams per pound per day in chickens, § 520.2330 Sulfisoxazole tablets. 3.5 to 55 milligrams per pound per day (a) Specifications. Each tablet con- in turkeys, and approximately 6 milli- tains 260 milligrams (4 grains) of grams per pound per day in cattle and sulfisoxazole. calves depending on the age, class of (b) Sponsor. See No. 054771 in animal, ambient temperature, and § 510.600(c) of this chapter. other factors. A withdrawal period has (c) Conditions of use—(1) Amount. Ad- not been established for minister one tablet orally per 4 pounds sulfaquinoxaline in preruminating of body weight. calves. Do not use in calves to be proc- (2) Indications for use. Use in dogs and essed for veal. Not for use in lactating cats as an aid in treatment of bacterial dairy cattle. Do not give to chickens, pneumonia and bacterial enteritis turkeys or cattle within 10 days of when caused by organisms sensitive to slaughter for food. Do not medicate sulfisoxazole. chickens or turkeys producing eggs for (3) Limitations. Repeat dosage at 24- human consumption. Make fresh drink- hour intervals until 2 to 3 days after ing water daily. Federal law restricts disappearance of clinical symptoms. this drug to use by or on the order of a (Administration of one-half daily dos- licensed veterinarian. age at 12-hour intervals or one-third [48 FR 3964, Jan. 28, 1983, as amended at 48 daily dosage at 8-hour intervals will FR 26762, June 10, 1983; 55 FR 29843, July 23, provide a more constant blood level.) 1990; 59 FR 28769, June 3, 1994; 59 FR 33197, Provide adequate supply of drinking June 28, 1994; 61 FR 24443, May 15, 1996; 61 FR water. If symptoms persist after using 63711, Dec. 2, 1996; 62 FR 37712, July 15, 1997; this preparation for 2 or 3 days, consult 65 FR 10705, Feb. 29, 2000; 69 FR 41427, July 9, a veterinarian. 2004; 69 FR 60547, Oct. 12, 2004; 74 FR 36112, July 22, 2009; 78 FR 17596, Mar. 22, 2013; 79 FR [43 FR 60895, Dec. 29, 1978, as amended at 79 28831, May 20, 2014; 81 FR 22523, Apr. 18, 2016; FR 28831, May 20, 2014] 81 FR 36789, June 8, 2016; 81 FR 59134, Aug. 29, 2016; 81 FR 94990, Dec. 27, 2016] § 520.2335 Telmisartan. (a) Specifications. Each milliliter of § 520.2325b Sulfaquinoxaline drench. solution contains 10 milligrams (mg) (a) Specifications. A soluble powder telmisartan. containing 25 percent sulfaquinoxaline. (b) Sponsor. See No. 000010 in (b) Sponsor. See No. 016592 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Ad- (c) Related tolerances. See § 556.685 of minister 1.5 mg/kilogram (kg) (0.68 mg/ this chapter. pound (lb)) orally twice daily for 14 (d) Conditions of use in cattle—(1) days, followed by 2 mg/kg (0.91 mg/lb) Amount. Administer 1 teaspoon of 25 orally once daily. percent sulfaquinoxaline soluble pow- (2) Indications for use. For the control der for each 125 pounds of body weight of systemic hypertension in cats. for 3 to 5 days as a drench. (3) Limitations. Federal law restricts this drug to use by or on the order of a (2) Indications for use. For the control licensed veterinarian. and treatment of outbreaks of coccidiosis in cattle and calves caused by [83 FR 64740, Dec. 18, 2018] Eimeria bovis or E. zuernii. (3) Limitations. Not for use in lac- § 520.2340 Tepoxalin. tating dairy cattle. A withdrawal pe- (a) Specifications. Each tablet con- riod has not been established for this tains 30, 50, 100, or 200 milligrams (mg) product in preruminating calves. Do tepoxalin. not use in calves to be processed for (b) Sponsor. See No. 000061 in veal. Federal law restricts this drug to § 510.600(c) of this chapter.

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(c) Conditions of use in dogs—(1) by or on the order of a licensed veteri- Amount. 10 mg per kilogram (/kg) daily; narian. or 20 mg/kg on the initial day of treatment, followed by 10 mg/kg daily. [57 FR 37327, Aug. 18, 1992, as amended at 79 FR 28831, May 20, 2014] (2) Indications for use. For the control of pain and inflammation associated § 520.2345c Tetracycline boluses. with osteoarthritis. (3) Limitations. Federal law restricts (a) Specifications. Each bolus contains this drug to use by or on the order of a 500 milligrams of tetracycline (as the licensed veterinarian. hydrochloride). (b) Sponsor. See No. 054771 in [68 FR 34795, June 11, 2003] § 510.600(c) of this chapter. § 520.2345 Tetracycline. (c) Related tolerances. See § 556.720 of this chapter. § 520.2345a Tetracycline capsules. (d) Conditions of use. Calves—(1) (a) Specifications. Each capsule con- Amount. 10 milligrams per pound of tains 50, 100, 125, 250, or 500 milligrams body weight per day in divided doses. (mg) tetracycline hydrochloride. (i) Indications for use. Control and (b) Sponsor. See No. 054771 in treatment of bacterial enteritis § 510.600(c) of this chapter. (scours) caused by E. coli and bacterial (c) Conditions of use in dogs—(1) pneumonia caused by Pasteurella spp., Amount. 25 mg per pound of body Hemophilus spp., and Klebsiella spp. weight per day in divided doses every 6 (ii) Limitations. Administer orally for hours. 3 to 5 days; do not slaughter animals (2) Indications for use. For treatment for food within 14 days of treatment; of infections caused by organisms sen- use as sole source of tetracycline. sitive to tetracycline hydrochloride, (2) Amount. 10 milligrams per pound such as bacterial gastroenteritis due to of body weight per day in two divided E. coli and urinary tract infections due doses. to Staphylococcus spp. and E. coli. (i) Indications for use. Treatment of (3) Limitations. Federal law restricts bacterial pneumonia caused by orga- this drug to use by or on the order of a nisms susceptible to tetracycline, bac- licensed veterinarian. terial enteritis caused by E. coli, and [70 FR 50182, Aug. 26, 2005, as amended at 73 salmonella organisms susceptible to FR 18442, Apr. 4, 2008; 79 FR 28831, May 20, tetracycline. 2014] (ii) Limitations. Administer orally for not more than 5 days; do not slaughter § 520.2345b Tetracycline tablets. animals for food within 12 days of (a) Specifications. Each tablet con- treatment; use as sole source of tetra- tains 100, 250, or 500 milligrams of tet- cycline. racycline (as the hydrochloride). (b) Sponsor. See No. 054771 in [57 FR 37328, Aug. 18, 1992, as amended at 67 § 510.600(c) of this chapter. FR 78355, Dec. 24, 2002; 79 FR 28831, May 20, 2014; 81 FR 67151, Sept. 30, 2016] (c) Conditions of use. Dogs—(1) Amount. 25 milligrams per pound of § 520.2345d Tetracycline powder. body weight per day in divided doses every 6 hours. (a) Specifications. Each pound of pow- (2) Indications for use. Treatment of der contains 25, 102.4, or 324 grams tet- infections caused by organisms sen- racycline hydrochloride. sitive to tetracycline hydrochloride, (b) Sponsors. See sponsors listed in such as bacterial gastroenteritis due to § 510.600(c) of this chapter for condi- E. coli and urinary tract infections due tions of use as in paragraph (d) of this to Staphylococcus spp. and E. coli. section: (3) Limitations. Administer orally; (1) No. 054771: 25 grams per pound as continue treatment until symptoms of in paragraphs (d)(3) and (d)(4) of this the disease have subsided and tempera- section. ture is normal for 48 hours; not for use (2) No. 066104: 25, 102.4, and 324 grams in animals raised for food production; per pound as in paragraph (d) of this Federal law restricts this drug to use section.

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(3) Nos. 016592 and 054771: 25, 102.4, and per gallon. Infectious synovitis: 200 to 324 grams per pound as in paragraph (d) 400 milligrams per gallon. of this section. (ii) Indications for use. Control of (4) Nos. 016592, 054925, 061133, and chronic respiratory disease (CRD or 076475: 324 grams per pound as in para- air-sac disease) caused by Mycoplasma graph (d) of this section. gallisepticum and E. coli; control of in- (5) No. 016592: 25 grams per pound as fectious synovitis caused by M. in paragraphs (d)(1) and (d)(2) of this synoviae susceptible to tetracycline. section. (iii) Limitations. Administer for 7 to (c) Related tolerances. See § 556.720 of 14 days; do not slaughter for food with- this chapter. in 4 days of treatment; not for use in (d) Conditions of use. It is adminis- chickens producing eggs for human tered in drinking water as follows: consumption; prepare a fresh solution (1) Calves—(i) Amount. 10 milligrams daily; use as the sole source of tetra- per pound of body weight per day in di- cycline. Federal law restricts this drug vided doses. to use by or on the order of a licensed (ii) Indications for use. Control and veterinarian. treatment of bacterial enteritis (4) Turkeys—(i) Amount. For infec- (scours) caused by Escherichia coli and tious synovitis: 400 milligrams per gal- bacterial pneumonia (shipping fever lon. For complicating bacterial orga- complex) associated with Pasteurella nisms associated with bluecomb (trans- spp., Actinobacillus pleuropneumoniae missible enteritis or coronaviral enter- (Haemophilus spp.), and Klebsiella spp., itis): 25 milligrams per pound of body susceptible to tetracycline. weight per day. (iii) Limitations. Administer for 3 to 5 (ii) Indications for use. Control of in- days; do not slaughter animals for food fectious synovitis caused by M. within 4 days of treatment for No. synoviae; control of bluecomb com- 066104 and within 5 days of treatment plicated by organisms sensitive to tet- for Nos. 016592, 054771, 054925, 057561, and racycline. 061133; prepare a fresh solution daily; (iii) Limitations. Administer for 7 to use as the sole source of tetracycline. 14 days; do not slaughter for food with- A withdrawal period has not been es- in 4 days of treatment; not for use in tablished for this product in turkeys producing eggs for human con- preruminating calves. Do not use in sumption; prepare a fresh solution calves to be processed for veal. Federal daily; use as the sole source of tetra- law restricts this drug to use by or on cycline. Federal law restricts this drug the order of a licensed veterinarian. to use by or on the order of a licensed (2) —(i) 10 milligrams Swine Amount. veterinarian. per pound of body weight per day in divided doses. [59 FR 17693, Apr. 14, 1994, as amended at 59 (ii) Indications for use. Control and FR 19133, Apr. 22, 1994; 62 FR 5319, Feb. 5, treatment of bacterial enteritis 1997; 62 FR 35076, June 30, 1997; 62 FR 46668, (scours) caused by E. coli and bacterial Sept. 4, 1997; 62 FR 55160, Oct. 23, 1997; 64 FR pneumonia associated with Pasteurella 37673, July 13, 1999; 67 FR 78355, Dec. 24, 2002; 70 FR 16934, Apr. 4, 2005; 70 FR 67353, Nov. 7, spp., A. pleuropneumoniae (Haemophilus 2005; 71 FR 13542, Mar. 16, 2006; 75 FR 10166, spp.), and Klebsiella spp., susceptible to Mar. 5, 2010; 75 FR 12981, Mar. 18, 2010; 76 FR tetracycline. 17338, Mar. 29, 2011; 77 FR 20988, Apr. 9, 2012; (iii) Limitations. Administer for 3 to 5 78 FR 21060, Apr. 9, 2013; 79 FR 28831, May 20, days; do not slaughter animals for food 2014; 81 FR 17607, Mar. 30, 2016; 81 FR 22523, within 7 days of treatment for No. Apr. 18, 2016; 81 FR 94990, Dec. 27, 2016; 83 FR 066104 and within 4 days of treatment 48946, Sept. 28, 2018; 84 FR 8973, Mar. 13, 2019] for Nos. 016592, 054771, 054925, 057561, and 061133; prepare a fresh solution daily; § 520.2345e Tetracycline solution. use as the sole source of tetracycline. (a) Specifications. Each milliliter con- Federal law restricts this drug to use tains the equivalent of either 25 or 100 by or on the order of a licensed veteri- milligrams of tetracycline hydro- narian. chloride. (3) Chickens—(i) Amount. Chronic res- (b) Sponsor. See No. 054771 in piratory disease: 400 to 800 milligrams § 510.600(c) of this chapter.

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(c) Conditions of use—(1) Dogs—(i) (3) Limitations. Federal law restricts Amount. 25 milligrams per pound of this drug to use by or on the order of a body weight per day in divided doses licensed veterinarian. every 6 hours. [57 FR 37329, Aug. 18, 1992, as amended at 79 (ii) Indications for use. Treatment of FR 28831, May 20, 2014] infections caused by organisms sensitive to tetracycline hydrochloride, § 520.2345g Tetracycline hydrochloride such as bacterial gastroenteritis due to and sodium novobiocin tablets. Escherichia coli and urinary tract infec- (a) Specifications. Each tablet con- tions due to Staphylococcus spp. and E. tains the equivalent of 60 milligrams of coli. tetracycline hydrochloride and 60 mil- (iii) Limitations. Administer orally; ligrams of novobiocin, or 180 milli- continue treatment until symptoms grams of tetracycline hydrochloride have subsided and the temperature is and 180 milligrams of novobiocin. normal for 48 hours; not for use in ani- (b) Sponsor. See No. 054771 in mals which are raised for food produc- § 510.600(c) of this chapter. tion; Federal law restricts this drug to (c) Conditions of use in dogs—(1) use by or on the order of a licensed vet- Amount. 10 milligrams of each anti- erinarian. biotic per pound of body weight (one single-strength tablet for each 6 pounds (2) Dogs and cats—(i) Amount. 25 milli- or one triple-strength tablet for each 18 grams per pound of body weight per pounds). day in divided doses every 6 hours. (2) Indications for use. Treatment of (ii) Indications for use. Treatment of acute or chronic canine respiratory in- infections caused by organisms suscep- fections such as tonsillitis, bronchitis, tible to tetracycline hydrochloride, and tracheobronchitis when caused by such as bacterial gastroenteritis due to pathogens susceptible to tetracycline E. coli and urinary tract infections due and/or novobiocin, such as Staphy- to Staphylococcus spp. and E. coli. lococcus spp. and Escherichia coli. (iii) Limitations. Administer orally; (3) Limitations. Federal law restricts continue treatment until the tempera- this drug to use by or on the order of a ture has been normal for 48 hours; not licensed veterinarian. for use in food-producing animals; Fed- [57 FR 37329, Aug. 18, 1992, as amended at 79 eral law restricts this drug to use by or FR 28831, May 20, 2014] on the order of a licensed veterinarian. § 520.2345h Tetracycline hydro- [57 FR 37329, Aug. 18, 1992, as amended at 79 chloride, sodium novobiocin, and FR 28831, May 20, 2014] prednisolone tablets. § 520.2345f Tetracycline phosphate (a) Specifications. Each tablet con- complex and sodium novobiocin tains the equivalent of 60 milligrams of capsules. tetracycline hydrochloride, 60 milligrams of novobiocin, and 1.5 milli- (a) Specifications. Each capsule con- grams of prednisolone or 180 milli- tains the equivalent of 60 milligrams of grams of tetracycline hydrochloride, tetracycline hydrochloride and 60 mil- 180 milligrams of novobiocin, and 4.5 ligrams of novobiocin. milligrams of prednisolone. (b) Sponsor. No. 054771 in § 510.600(c) of (b) Sponsor. See No. 054771 in this chapter. § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) (c) Conditions of use in dogs—(1) Amount. 10 milligrams of each anti- Amount. 10 milligrams of each antibiotic per pound of body weight (1 cap- biotic and 0.25 milligram of prednis- sule for each 6 pounds) every 12 hours. olone per pound of body weight (one (2) Indications for use. Treatment of single-strength tablet for each 6 pounds acute or chronic canine respiratory in- or one triple-strength tablet for each 18 fections such as tonsillitis, bronchitis, pounds) every 12 hours for 48 hours. and tracheobronchitis when caused by Treatment is to be continued with pathogens susceptible to tetracycline novobiocin and tetracycline alone at and/or novobiocin, such as Staphy- the same dose schedule for an addi- lococcus spp. and Escherichia coli. tional 3 days or longer as needed.

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(2) Indications for use. Treatment of (2) No. 000010 for use as in paragraph acute and chronic canine respiratory (d)(1)(ii) of this section. infections such as tonsillitis, bron- (3) No. 012286 for use as in paragraph chitis, and tracheobronchitis when (d)(2) of this section. caused by pathogens susceptible to tet- (c) Related tolerances. See § 556.730 of racycline and/or novobiocin, such as this chapter. Staphylococcus spp. and Escherichia coli, (d) Conditions of use. It is used as fol- when it is necessary to initially reduce lows: the severity of associated clinical (1) Horses—(i) [Reserved] signs. (ii) Route of administration. In feed. (3) Limitations. Federal law restricts (a) Amount. 2 grams per 100 pounds of this drug to use by or on the order of a body weight. licensed veterinarian. (1) Indications for use. For control of [57 FR 37329, Aug. 18, 1992, as amended at 79 large and small strongyles, FR 28832, May 20, 2014] Strongyloides, and pinworms of the genera Strongylus, Cyathostomum, § 520.2362 Thenium closylate. Cylicobrachytus and related genera, (a) Specifications. Each tablet con- Craterostomum, Oesophagodontus, tains thenium closylate equivalent to Poteriostomum, Oxyuris, and 500 milligrams thenium base. Strongyloides. (a) Specifications. Thenium closylate (2) Limitations. Administer in a single tablets contain thenium closylate dosage mixed with the normal grain ra- equivalent to 500 milligrams thenium tion given at one feeding. Warning: Not as base in each tablet. for use in horses intended for food. (b) Sponsor. See No. 000061 in (b) Amount. 4 grams per 100 pounds of § 510.600(c) of this chapter. body weight. (c) Conditions of use in dogs—(1) (1) Indications for use. For control of Amount. Dogs weighing over 10 pounds: ascarids of the genus Parascaris. Administer 1 tablet as a single dose. (2) Limitations. Administer in a single Dogs weighing 5 to 10 pounds: Adminis- dosage mixed with the normal grain ra- tered one-half tablet twice during a tion given at one feeding. Warning: Not single day. Repeat treatment after 2 or for use in horses intended for food. 3 weeks. (2) Cattle—(i) Route of administration. (2) Indications for use. For treatment In feed block. of canine ancylostomiasis by the re- (ii) Amount. 3.3 percent block con- moval from the intestines of the adult sumed at the recommended level of 0.11 forms of the species Ancylostoma pound per 100 pounds of body weight caninum and Uncinaria stenocephala per day. (hookworms). (iii) Indications for use. For control of (3) Limitations. Federal law restricts infections of gastrointestinal this drug to use by or on the order of a roundworms (Trichostrongylus, licensed veterinarian. Haemonchus, Ostertagia and Cooperia). (iv) Limitations. Administer to cattle [40 FR 13838, Mar. 27, 1975, as amended at 41 FR 53477, Dec. 7, 1976; 46 FR 48642, Oct. 2, 1981; on pasture or range accustomed to 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, mineral protein block feeding for 3 1997; 79 FR 28832, May 20, 2014] days. Milk taken from animals during treatment and within 96 hours (8 § 520.2380 Thiabendazole oral dosage milkings) after the latest treatment forms. must not be used for food. Do not treat cattle within 3 days of slaughter. For a § 520.2380a Thiabendazole top dress- satisfactory diagnosis, a microscopic ing and mineral protein block. fecal examination should be performed (a) Specifications. Conforms to N.F. by a veterinarian or diagnostic labora- XII. tory prior to worming. Animals main- (b) Sponsors. See sponsors in tained under conditions of constant § 510.600(c) of this chapter for use as in worm exposure may require re-treat- paragraph (d) of this section. ment within 2 to 3 weeks. Animals that (1) [Reserved] are severely parasitized, sick, or off

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feed should be isolated and a veteri- (ii) Indications for use. For control of narian consulted for advice concerning infections with Strongyloides ransomi. treatment. These infections are commonly found in Southeastern United States. [40 FR 13838, Mar. 27, 1975, as amended at 41 FR 9149, Mar. 3, 1976; 62 FR 63271, Nov. 28, (iii) Limitations. Administer to baby 1997; 70 FR 32489, June 3, 2005; 73 FR 35340, pigs (1 to 8 weeks of age). Treatment June 23, 2008; 79 FR 28832, May 20, 2014; 83 FR may be repeated in 5 to 7 days if nec- 48946, Sept. 28, 2018; 84 FR 39183, Aug. 9, 2019] essary. Before treatment, obtain an accurate diagnosis from a veterinarian or § 520.2380b Thiabendazole drench or diagnostic laboratory. Do not treat paste. within 30 days of slaughter. (a) Specifications. Conforms to N.F. (3) Cattle. Orally as a drench and in XII. paste form using a dosing gun designed (b) Sponsor. See No. 000010 in for the product. § 510.600(c) of this chapter. (i) Amount. 3 grams per 100 pounds of (c) Related tolerances. See § 556.730 of body weight. this chapter. (a) Indications for use. Control of in- (d) Conditions of use. It is used as fol- fections of gastrointestinal lows: roundworms (Trichostrongylus spp., Haemonchus spp., Nematodirus spp., (1) Horses. As a single liquid oral Ostertagia spp., and Oesophagostomum dose, administered as a drench or by radiatum). stomach tube; or as an oral paste. (b) Limitations. For most effective re- (i) Amount. 2 grams per 100 pounds of sults, severely parasitized animals or body weight. those constantly exposed to helminth (a) Indications for use. For the control infection should be re-treated every 2 of infections of large strongyles to 3 weeks. Milk taken from treated (Strongylus vulgaris, Strongylus animals within 96 hours (8 milkings) endentatus), small strongyles after the latest treatment must not be (Cyathastomum, Cylicobrachytus and reused for food. Do not treat cattle with- lated genera, Craterostomum, in 3 days of slaughter. For a satisfac- Oesophagodontus, Poteriostomum), tory diagnosis, a microscopic fecal ex- pinworms (Oxyuris), and threadworms amination should be performed prior to (Strongyloides). worming. (b) Limitations. Not for use in horses (ii) Amount. 5 grams per 100 pounds of to be slaughtered for food purposes. body weight. When administered by stomach tube, (a) Indications for use. Control of infor use only by or on the order of a li- fections of Cooperia spp. or severe infec- censed veterinarian. When for use as a tions of other species in paragraph liquid oral drench or an oral paste, con- (e)(3)(i)(a) of this section. sult your veterinarian for assistance in (b) Limitations. For most effective re- the diagnosis, treatment, and control sults, severely parasitized animals or of parasitism. those constantly exposed to helminth (ii) Amount. 4 grams per 100 pounds of infection should be re-treated every 2 body weight. to 3 weeks. Milk taken from treated (a) Indications for use. For control of animals within 96 hours (8 milkings) infections of ascardis (Parascaris). after the latest treatment must not be (b) Limitations. Not for use in horses used for food. Do not treat cattle with- to be slaughtered for food purposes. in 3 days of slaughter. For a satisfac- When administered by stomach tube, tory diagnosis, a microscopic fecal ex- use only by or on the order of a li- amination should be performed prior to censed veterinarian. When for use as a worming. liquid oral drench or an oral paste, con- (4) Sheep and goats. Orally, as a sult your veterinarian for assistance in drench. the diagnosis, treatment, and control (i) Amount. 2 grams per 100 pounds of of parasitism. body weight. (2) Pigs. As an oral paste. (ii) Indications for use. Control of in- (i) Amount. 200 milligrams for each 5 fections of gastrointestinal to 7 pounds of body weight per dose. roundworms in sheep and goats.

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(Trichostrongylus spp., Haemonchus spp., spp., Haemonchus spp., Nematodirus spp., Ostertagia spp., Cooperia spp., Ostertagia spp., and Oesophagostomum Nematodirus spp., Bunostomum spp., radiatum). Strongyloides spp., Chabertia spp., and (b) Limitations. As a single oral dose; Oesophagostomum spp.); also active may repeat once in 2 to 3 weeks; do not from 3 hours to 3 days following treat- treat animals within 3 days of slaugh- ment against ova and larvae passed by ter; milk taken from treated animals sheep (good activity against within 96 hours (8 milkings) after the Trichostrongylus colubriformis and axei, latest treatment must not be used for Ostertagia spp., Bunostomum spp., food. Nematodirus spp., and Strongyloides spp.; (ii) Amount. 5 grams per 100 pounds of less effective against Haemonchus body weight. contortus and Oesophagostomum spp.). (a) Indications for use. Control of se- (iii) Limitations. As a single oral dose; vere infections of gastrointestinal do not treat animals within 30 days of roundworms (genera Trichostrongylus slaughter; milk taken from treated spp., Haemonchus spp., Nematodirus spp., animals within 96 hours (8 milkings) Ostertagia spp., and Oesophagostomum after the latest treatment must not be radiatum). Control of infections with used for food; in severe infections in Cooperia spp. sheep, treatment should be repeated in (b) Limitations. As a single oral dose; 2 to 3 weeks. as a drench or bolus; may repeat once (5) Goats. Orally, as a drench. in 2 to 3 weeks; do not treat animals (i) Amount. 3 grams per 100 pounds of within 3 days of slaughter; milk taken body weight. from treated animals within 96 hours (8 (ii) Indications for use. Control of se- milkings) after the latest treatment vere infections of gastrointestinal must not be used for food. roundworms (Trichostrongylus spp., (2) Sheep and goats. In a bolus. Haemonchus spp., Ostertagia spp., (i) Amount. 2 grams per 100 pounds of Cooperia spp., Nematodirus spp., body weight. Bunostomum spp., Strongyloides spp., (ii) Indications for use. Control of in- Chabertia spp., and Oesophagostomum fections of gastrointestinal spp.). roundworms in sheep and goats (gen- (iii) Limitations. As a single oral dose; eral Trichostrongylus spp., Haemonchus do not treat animals within 30 days of spp., Ostertagia spp., Cooperia spp., slaughter; milk taken from treated Nematodirus spp., Bunostomum spp., animals within 96 hours (8 milkings) Strongyloides spp., Chabertia spp., and after the latest treatment must not be Oesophagostomum spp.); also active used for food; treatment should be re- from 3 hours to 3 days following treat- peated in 2 to 3 weeks. ment against ova and larvae passed by [40 FR 13838, Mar. 27, 1975, as amended at 41 sheep (good activity against T. FR 9149, Mar. 3, 1976; 41 FR 47424, Oct. 29, colubriformis and axei, Ostertagia spp., 1976; 62 FR 63271, Nov. 28, 1997; 79 FR 28832, Bunostomum spp., Nematodirus spp., and May 20, 2014; 84 FR 39183, Aug. 9, 2019] Strongyloides spp.; less effective against Haemonchus contortus and § 520.2380c Thiabendazole bolus. Oesophagostomum spp.). (a) Specifications. Conforms to N.F. (iii) Limitations. As a single oral dose; XII. do not treat animals within 30 days of (b) Sponsor. See No. 000010 in slaughter; milk taken from treated § 510.600(c) of this chapter. animals within 96 hours (8 milkings) (c) Related tolerances. See § 556.730 of after the latest treatment must not be this chapter. used for food; in severe infections in (d) Conditions of use. It is used as fol- sheep, treatment should be repeated in lows: 2 to 3 weeks. (1) Cattle. In a bolus. (3) Goats. In a bolus. (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

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spp., Haemonchus spp., Ostertagia spp., drench or by stomach tube suspended Cooperia spp., Nematodirus spp., in 1 pint of warm water; by dose sy- Bunostomum spp., Strongyloides spp., ringe suspended in 1⁄2 ounce of water for Chabertia spp., and Oesophagostomum each 100 pounds of body weight; or spp.). sprinkled over a small amount of daily (iii) Limitations. As a single oral dose; feed. do not treat animals within 30 days of (2) Indications for use. Treatment of slaughter; milk taken from treated infections of large strongyles (genus animals within 96 hours (8 milkings) Strongylus), small strongyles (genera after the latest treatment must not be Cyathostomum, Cylicobrachytus, and reused for food; treatment should be related genera Craterostomum, peated in 2 to 3 weeks. Oesophagodontus, Poteriostomum), [40 FR 13838, Mar. 27, 1975, as amended at 41 pinworms (Oxyuris), threadworms FR 9149, Mar. 3, 1976; 62 FR 63271, Nov. 28, (Strongyloides), and ascarids (Parascaris) 1997; 79 FR 28832, May 20, 2014; 84 FR 39183, in horses. Aug. 9, 2019] (3) Limitations. Do not use in horses intended for human consumption. If § 520.2380d Thiabendazole and piperazine citrate. the label bears directions for administration by stomach tube or drench, it (a) Specifications. Each fluid ounce of shall also bear the statement ‘‘Caution: suspension contains 2 grams of Federal law restricts this drug to use thiabendazole and 2.5 grams of piper- by or on the order of a licensed veteri- azine (from piperazine citrate). narian.’’; if not labeled for use by stom- (b) Sponsor. See No. 000010 in ach tube or drench, the label shall bear § 510.600(c) of this chapter. the statement, ‘‘Consult your veteri- (c) Conditions of use in horses—(1) narian for assistance in the diagnosis, Amount. Administer 1 ounce of suspen- treatment, and control of parasitism.’’ sion per 100 pounds of body weight by stomach tube or as a drench. [46 FR 18963, Mar. 27, 1981, as amended at 46 (2) Indications for use. For the control FR 52330, Oct. 27, 1981; 62 FR 63271, Nov. 28, of large strongyles, small strongyles, 1997; 79 FR 28832, May 20, 2014. Redesignated pinworms, Strongyloides and ascarids and amended at 84 FR 39183, Aug. 9, 2019] (including members of the genera Strongylus spp., Cyathostomum spp., § 520.2380f Thiabendazole and triclorfon. Cylicobrachytus spp. and related genera Craterostomum spp., Oesophagodontus (a) Specifications. The drug contains 5 spp., Poteriostomum spp., Oxyuris spp., grams of thiabendazole with 4.5 grams Strongyloides spp., and Parascaris spp.). of trichlorfon, or 20 grams of (3) Limitations. Do not use in horses thiabendazole with 18 grams of intended for human consumption. Fed- trichlorfon. eral law restricts this drug to use by or (b) Sponsor. See No. 017135 in on the order of a licensed veterinarian. § 510.600(c) of this chapter. [40 FR 13838, Mar. 27, 1975, as amended at 62 (c) Conditions of use in horses—(1) FR 63271, Nov. 28, 1997; 79 FR 28832, May 20, Amount. Administer 2 grams of 2014; 84 FR 39183, Aug. 9, 2019] thiabendazole with 1.8 grams of trichlorfon per 100 pounds of body § 520.2380e Thiabendazole and piper- weight sprinkled on the animals’ usual azine phosphate. daily ration of feed, or may be mixed in (a) Specifications. Each ounce of water 5 to 10 fluid ounces of water and admin- dispersible powder contains 6.67 grams istered by stomach tube or drench. of thiabendazole and 8.33 grams of pi- (2) Indications for use. For the treat- perazine (as piperazine phosphate). ment and control of bots (Gasterophilus (b) Sponsor. See No. 000010 in spp.), large strongyles (Strongylus spp.), § 510.600(c) of this chapter. small strongyles (genera (c) Conditions of use in horses—(1) Cyathostomum, Cylicobrachytus, Amount. 2 grams of thiabendazole and Craterostomum, Oesophagodontus, 2.5 grams of piperazine (0.3 ounce of Poteriostomum), pinworms (Oxyuris spp., powder) per 100 pounds of body weight. Strongyloides spp.), and ascarids Use a single oral dose. Administer as a (Parascaris spp.).

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(3) Limitations. Do not use in horses may occur. The effects of tiamulin on intended for human consumption. Fed- swine reproductive performance, preg- eral law restricts this drug to use by or nancy, and lactation have not been de- on the order of a licensed veterinarian. termined. [40 FR 23071, May 28, 1975, as amended at 48 [70 FR 75017, Dec. 19, 2005, as amended at 74 FR 48229, Oct. 18, 1983; 79 FR 28832, May 20, FR 7180, Feb. 13, 2009; 75 FR 54492, Sept. 8, 2014. Redesignated at 84 FR 39183, Aug. 9, 2010; 77 FR 56770, Sept. 14, 2012; 78 FR 17596, 2019] Mar. 22, 2013; 80 FR 13229, Mar. 13, 2015; 85 FR 18119, Apr. 1, 2020] § 520.2455 Tiamulin. (a) Specifications. (1) Each gram of § 520.2471 Tilmicosin. soluble powder contains 450 milligrams (a) Specifications. Each milliliter of (mg) tiamulin hydrogen fumarate. concentrate solution contains 250 milli- (2) Each milliliter (mL) of solution grams (mg) tilmicosin as tilmicosin contains 125 mg (12.5 percent) tiamulin phosphate. hydrogen fumarate. (b) Sponsor. See No. 058198 in (3) Each mL of solution contains 123 § 510.600(c) of this chapter. mg (12.3 percent) tiamulin hydrogen fu- (c) Tolerances. See § 556.735 of this marate. chapter. (b) Sponsors. See sponsor numbers in (d) Conditions of use in swine—(1) § 510.600(c) of this chapter for use as in Amount. Administer in drinking water paragraph (d) of this section. at a concentration of 200 mg per liter (1) No. 058198 for products described for 5 consecutive days. in paragraphs (a)(1) and (a)(2) of this (2) Indications for use—(i) For the con- section. trol of swine respiratory disease associ- (2) No. 066104 for the product de- ated with Pasteurella multocida and scribed in paragraph (a)(1) of this sec- Haemophilus parasuis in groups of swine tion. in buildings where a respiratory dis- (3) No. 054771 for the product de- ease outbreak is diagnosed. scribed in paragraph (a)(3) of this sec- (ii) For the control of swine res- tion. piratory disease associated with Myco- (4) No. 061133 for product described in plasma hyopneumoniae in the presence paragraph (a)(2) of this section. of Porcine Reproductive and Res- (c) Related tolerances. See § 556.732 of piratory Syndrome Virus (PRRSV) in this chapter. groups of swine in buildings where a (d) Conditions of use in swine—(1) respiratory disease outbreak is diag- Amounts and indications for use. Admin- nosed. ister in drinking water for 5 consecu- (3) Limitations. Swine intended for tive days: human consumption must not be (i) 3.5 mg per (/) lb of body weight slaughtered within 7 days of the last daily for treatment of swine dysentery treatment with this product. Federal associated with Brachyspira law restricts this drug to use by or on hyodysenteriae susceptible to tiamulin. the order of a licensed veterinarian. (ii) 10.5 mg/lb of body weight daily for [79 FR 18158, Apr. 1, 2014, as amended at 81 treatment of swine pneumonia due to FR 17608, Mar. 30, 2016; 81 FR 48702, July 26, Actinobacillus pleuropneumoniae suscep- 2016] tible to tiamulin. (2) Limitations. Use as only source of § 520.2473 Tioxidazole oral dosage drinking water. Prepare fresh medi- forms. cated water daily. Withdraw medication 3 days before slaughter following § 520.2473a Tioxidazole granules. treatment at 3.5 mg/lb and 7 days be- (a) Specifications. Each gram of gran- fore slaughter following treatment at ules contains 200 milligrams of 10.5 mg/lb of body weight. Swine being tioxidazole. treated with tiamulin should not have (b) Sponsor. See No. 000061 in access to feeds containing polyether § 510.600(c) of this chapter. ionophores (e.g., lasalocid, monensin, (c) Conditions of use—(1) Horses—(i) narasin, salinomycin, or Amount. 5 milligrams per pound of body semduramycin) as adverse reactions weight as a single dose.

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

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(i) Amount. Administer 0.005 to 0.01 (ascarids, Parascaris equorum), and mg/lb of body weight twice daily, sprin- pinworms (Oxyuris equi). kled (top-dressed) on a small portion of (3) Limitations. Do not use in horses feed. Therapy may be initiated with a intended for human consumption. Fed- single injection of triamcinolone eral law restricts this drug to use by or acetonide suspension as in § 522.2483 of on the order of a licensed veterinarian. this chapter, in which case triamcinolone acetonide oral powder [45 FR 48127, July 18, 1980. Redesignated and should be administered beginning 3 or 4 amended at 79 FR 28833, May 20, 2014] days after the injection. § 520.2520c Trichlorfon granules. (ii) Indications for use. As an anti-inflammatory agent. (a) Specifications. Each package con- (iii) Limitations. Federal law restricts tains either 18.2 or 36.4 g of trichlorfon. this drug to use by or on the order of a (b) Sponsor. See No. 054771 in licensed veterinarian. Do not use in § 510.600(c) of this chapter. horses intended for human consump- (c) Conditions of use in horses—(1) tion. Amount. 18.2 milligrams per pound of [75 FR 10166, Mar. 5, 2010] body weight. (2) Indications for use. For horses for § 520.2520 Trichlorfon oral dosage removal of bots (Gastrophilus nasalis, forms. Gastrophilus intestinalis), large roundworms (ascarids, Parascaris § 520.2520a Trichlorfon and atropine. equorum), and pinworms (Oxyuris equi). (a) Specifications. (1) For trichlorfon: (3) Limitations. Do not use in horses O,O-Dimethyl 2,2,2-trichloro-1-hydroxy- intended for human consumption. Fed- ethyl phosphonate. eral law restricts this drug to use by or (2) For atropine: Atropine N.F. on the order of a licensed veterinarian. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. [45 FR 48128, July 18, 1980. Redesignated and (c) Conditions of use in mice—(1) amended at 79 FR 28833, May 20, 2014] Amount. Administer 1.67 grams of § 520.2520d Trichlorfon, trichlorfon and 7.7 milligrams of atro- phenothiazine, and piperazine. pine per liter continuously for 7 to 14 days as the sole source of drinking (a) Specifications. Each 54.10 grams water. (1.91 ounces) of water dispersible pow- (2) Indications for use. For the treat- der contains 9.10 grams of trichlorfon, ment of Syphacia obvelata (pinworm) in 6.25 grams of phenothiazine, and the laboratory mice. equivalent of 20.0 grams of piperazine (3) Limitations. Federal law restricts base (as piperazine dihydrochloride). this drug to use by or on the order of a (b) Sponsor. See No. 054771 in licensed veterinarian. § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) [79 FR 28832, May 20, 2014] Amount. 18.2 milligrams (mg) of § 520.2520b Trichlorfon boluses. trichlorfon, 12.5 mg of phenothiazine, and 40 mg of piperazine base per pound (a) Each bolus contains Specifications. of body weight. either 7.3, 10.9, 14.6, or 18.2 g of (2) Indications for use. For removal of trichlorfon. bots (Gastrophilus nasalis, Gastrophilus (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. intestinalis), large strongyles (c) Conditions of use in horses—(1) (Strongylus vulgaris), small strongyles, Amount. 18.2 milligrams per pound of large roundworms (ascarids, Parascaris body weight, except for strongyles use equorum), and pinworms (Oxyuris equi). 36.4 milligrams per pound of body (3) Limitations. Do not use in horses weight. intended for human consumption. Fed- (2) Indications for use. For horses for eral law restricts this drug to use by or removal of bots (Gastrophilus nasalis, on the order of a licensed veterinarian. Gastrophilus intestinalis), large [48 FR 2757, Jan. 21, 1983. Redesignated and strongyles (Strongylus vulgaris), small amended at 79 FR 28833, May 20, 2014; 85 FR strongyles, large roundworms 4208, Jan. 24, 2020]

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EDITORIAL NOTE: At 79 FR 28833, May 20, dosage: for dogs weighing up to 10 2014, § 520.2520d was amended in part by redes- pounds, 1⁄2 tablet twice daily; for dogs ignating paragraph (e) as (c). This action weighing 11 to 20 pounds, 1 tablet twice could not be performed because paragraph (e) daily; for dogs weighing 21 to 40 did not exist. pounds, 2 tablets twice daily; and for § 520.2582 Triflupromazine. dogs weighing over 40 pounds, 3 tablets twice daily. After 4 days, reduce dosage (a) Specifications. Each tablet con- to one-half the initial dose or to an tains 10 or 25 milligrams (mg) amount sufficient to maintain remis- triflupromazine hydrochloride. sion of symptoms. (b) Sponsor. See No. 054771 in (2) Indications for use. For the relief of § 510.600(c) of this chapter. itching regardless of cause; and for re- (c) Conditions of use in dogs and cats— duction of inflammation commonly as- (1) Amount. Administer orally 1 to 2 mg sociated with most skin disorders of per pound of body weight daily, fol- dogs such as eczema, caused by inter- lowed by 1 mg daily. nal disorders, otitis, and dermatitis, al- (2) Indications for use. For relief of lergic, parasitic, pustular and nonspe- anxiety, to help control psychomotor cific. As adjunctive therapy in various over-activity, and to increase the toler- cough conditions including treatment ance of animals to pain and pruritus. of ‘‘kennel cough’’ or For use in various clinical procedures tracheobronchitis, bronchitis including which require the aid of a tranquilizer, allergic bronchitis, in tonsillitis, acute antiemetic, or preanesthetic. upper respiratory infections and (3) Limitations. Federal law restricts coughs of nonspecific origin. this drug to use by or on the order of a (3) Limitations. Federal law restricts licensed veterinarian. this drug to use by or on the order of a [79 FR 28833, May 20, 2014] licensed veterinarian.

§ 520.2598 Trilostane. [79 FR 28833, May 20, 2014] (a) Specifications. Each capsule con- § 520.2605 Trimeprazine and prednis- tains 5, 10, 30, 60, or 120 milligrams olone capsules. (mg) trilostane. (a) Specifications. Each capsule con- (b) Sponsor. See No. 043264 in § 510.600 tains: of this chapter. (1) 3.75 milligrams (mg) trimeprazine (c) Conditions of use in dogs—(1) in sustained released form (as Amount. The starting dose is 1.0 to 3.0 trimeprazine tartrate) and 1 mg pred- milligrams per pound (2.2 to 6.7 milli- nisolone (Capsule No. 1); or grams per kilogram) once a day. (2) 7.5 mg trimeprazine in sustained (2) Indications for use. For treatment release form (as trimeprazine tartrate) of pituitary-dependent and 2 mg prednisolone (Capsule No. 2). hyperadrenocorticism. For treatment (b) Sponsor. See No. 054771 in of hyperadrenocorticism due to § 510.600(c) of this chapter. adrenocortical tumor. (c) Conditions of use in dogs—(1) (3) Limitations. Federal law restricts Amount. Administer orally once daily this drug to use by or on the order of a an initial dosage: licensed veterinarian. (i) For dogs weighing up to 10 pounds: [74 FR 21767, May 11, 2009, as amended at 74 one Capsule No. 1; FR 30464, June 26, 2009; 80 FR 53460, Sept. 4, (ii) For dogs weighing 11 to 20 2015] pounds, one Capsule No. 2 or two Cap- sule No. 1; § 520.2604 Trimeprazine and prednis- (iii) For dogs weighing 21 to 40 olone tablets. pounds, two Capsule No. 2 or four Cap- (a) Specifications. Each tablet con- sule No. 1; and tains 5 milligrams (mg) trimeprazine (iv) For dogs weighing over 40 tartrate and 2 mg prednisolone. pounds, three Capsule No. 2 or six Cap- (b) Sponsor. See No. 054771 in sule No. 1. After 4 days, the dosage is § 510.600(c) of this chapter. reduced to approximately 1⁄2 the initial (c) Conditions of use in dogs—(1) dosage or to an amount just sufficient Amount. Administer orally an initial to maintain remission of symptoms.

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(2) Indications for use. For the relief of § 520.2611 Trimethoprim and sulfa- itching regardless of cause; and for re- diazine paste. duction of inflammation commonly as- (a) Specifications. Each gram (g) of sociated with most skin disorders of paste contains 67 milligrams (mg) dogs such as eczema, caused by inter- trimethoprim and 333 mg sulfadiazine. nal disorders, otitis, and dermatitis, al- (b) Sponsors. See sponsors in lergic, parasitic, pustular and nonspe- § 510.600(c) of this chapter: cific. As adjunctive therapy in various (1) No. 054771 for product adminis- cough conditions including treatment tered as in paragraph (c)(1)(i) of this of ‘‘kennel cough’’ or section. tracheobronchitis, bronchitis including (2) No. 000061 for product adminis- allergic bronchitis, in tonsillitis, acute tered as in paragraph (c)(1)(ii) of this upper respiratory infections and section. coughs of nonspecific origin. (c) Conditions of use in horses—(1) (3) Limitations. Federal law restricts Amount. Administer orally as a single this drug to use by or on the order of a daily dose for 5 to 7 days: licensed veterinarian. (i) 5 g of paste (335 mg trimethoprim [79 FR 28833, May 20, 2014] and 1,665 mg sulfadiazine) per 150 pounds (68 kilograms) of body weight § 520.2610 Trimethoprim and sulfa- per day. diazine tablets. (ii) 3.75 g of paste (250 mg trimethoprim and 1,250 mg sulfa- (a) Specifications. Each tablet con- diazine) per 110 pounds (50 kilograms) tains 30 milligrams (mg) (5 mg of body weight per day. trimethoprim and 25 mg sulfadiazine), (2) Indications for use. For use where 120 mg (20 mg trimethoprim and 100 mg systemic antibacterial action against sulfadiazine), 480 mg (80 mg sensitive organisms is required during trimethoprim and 400 mg sulfadiazine) treatment of acute strangles, res- or 960 mg (160 mg trimethoprim and 800 piratory infections, acute urogenital mg sulfadiazine). infections, and wound infections and (b) Sponsors. See Nos. 000061 and abscesses. 054771 in § 510.600(c) of this chapter. (3) Limitations. Not for use in horses (c) Conditions of use in dogs—(1) intended for human consumption. Fed- Amount. Administer orally at 30 mg per eral law restricts this drug to use by or kilogram of body weight (14 milligrams on the order of a licensed veterinarian. per pound) once daily. Alternatively, especially in severe infections, the ini- [71 FR 30802, May 31, 2006, as amended at 79 tial dose may be followed by one-half FR 28834, May 20, 2014] the recommended daily dose every 12 § 520.2612 Trimethoprim and sulfa- hours. 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 (2) Indications for use. The drug is (mL) of suspension contains: used in dogs where systemic anti- (1) 10 milligrams (mg) trimethoprim bacterial action against sensitive orga- and 50 mg sulfadiazine; or (2) 400 mg combined active ingredi- nisms is required, either alone or as an ents (67 mg trimethoprim and 333 mg adjunct to surgery or debridement with sulfadiazine). associated infection. The drug is indi- (b) Sponsors. See sponsor numbers in cated where control of bacterial infec- § 510.600 of this chapter: tion is required during the treatment (1) No. 000061 for use of product de- of acute urinary tract infections, acute scribed in paragraph (a)(1) for use as in bacterial complications of distemper, paragraph (c)(1) of this section. acute respiratory tract infections, (2) No. 051072 for use of product de- acute alimentary tract infections, scribed in paragraph (a)(2) for use as in wound infections, and abscesses. paragraph (c)(2) of this section. (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 1 mL (10 mg licensed veterinarian. trimethoprim and 50 mg sulfadiazine) [79 FR 28833, May 20, 2014] per 5 pounds (lb) of body weight once

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daily, or one-half the recommended eral law restricts this drug to use by or daily dose every 12 hours, for up to 14 on the order of a licensed veterinarian. consecutive days. (ii) Indications for use. The drug is [58 FR 36135, July 6, 1993, as amended at 64 FR 68289, Dec. 7, 1999; 79 FR 28834, May 20, used in dogs where systemic anti- 2014; 79 FR 64116, Oct. 28, 2014] bacterial action against sensitive organisms is required, either alone or as an § 520.2640 Tylosin. adjunct to surgery or debridement with associated infection. The drug is indi- (a) Specifications. Each container of cated where control of bacterial infec- soluble powder contains tylosin tar- tion is required during the treatment trate equivalent to either 100 or 256 of acute urinary tract infections, acute grams tylosin base. bacterial complications of distemper, (b) Sponsors—(1) Nos. 016592 and 058198 acute respiratory tract infections, for use as in paragraph (e) of this sec- acute alimentary tract infections, tion. wound infections, and abscesses. (2) No. 061133 for use as in paragraphs (iii) Limitations. Federal law restricts (e)(1)(i)(A), (e)(1)(ii), (e)(2), (e)(3), and this drug to use by or on the order of a (e)(4) of this section. licensed veterinarian. (c) Related tolerances. See § 556.746 of (2) Horses—(i) Amount. Administer this chapter. orally at a dosage of 24 mg combined (d) Special considerations. Federal law active ingredients per kilogram body restricts this drug to use by or on the weight (10.9 mg/lb) twice daily for 10 order of a licensed veterinarian. days. Administered by volume at 2.7 (e) Conditions of use—(1) Chickens—(i) mL per 45.4 kilograms of body weight Amounts and indications for use. (A) Ad- (2.7 mL/100 lb). minister 2 grams per gallon (528 parts (ii) Indications for use. For the treat- per million (ppm)) for 1 to 5 days as an ment of lower respiratory tract infec- aid in the treatment of chronic res- tions in horses caused by susceptible piratory disease (CRD) associated with strains of Streptococcus equi subsp. Mycoplasma gallisepticum in broiler and zooepidemicus. replacement chickens. For the control (iii) Limitations. Do not use in horses of CRD associated with M. gallisepticum intended for human consumption. Fed- at time of vaccination or other stress eral law restricts this drug to use by or in chickens. For the control of CRD as- on the order of a licensed veterinarian. sociated with Mycoplasma synoviae in broiler chickens. Treated chickens [78 FR 63872, Oct. 25, 2013, as amended at 85 FR 4208, Jan. 24, 2020] should consume enough medicated drinking water to provide 50 milli- § 520.2613 Trimethoprim and sulfa- grams (mg) tylosin per pound of body diazine powder. weight per day. (a) Specifications. Each gram of pow- (B) Administer 851 to 1,419 mg/gallon der contains 67 milligrams (mg) (225 to 375 ppm) for 5 days for the con- trimethoprim and 333 mg sulfadiazine. trol of mortality caused by necrotic en- (b) Sponsors. See Nos. 054771 and teritis associated with Clostridium 059051 in § 510.600(c) of this chapter. perfringens in broiler chickens. (c) Conditions of use in horses—(1) (ii) Limitations. Do not use in layers Amount. Administer orally 3.75 grams producing eggs for human consump- of powder per 110 pounds (50 kilograms) tion. Do not administer within 24 hours of body weight in a small amount of of slaughter. feed, as a single daily dose, for 5 to 7 (2) Turkeys—(i) Amount. 2 grams per days. 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 the reduc- and abscesses. tion in severity of effects of infectious (3) Limitations. Do not use in horses sinusitis associated with Mycoplasma intended for human consumption. Fed- gallisepticum.

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(iii) Limitations. Do not use in layers (b) Sponsor. See No. 066916 in producing eggs for human consump- § 510.600(c) of this chapter. tion. Do not administer within 5 days (c) Related tolerances. See § 556.748 of of slaughter. this chapter. (3) Swine—(i) Amount. 250 mg per gal- (d) Conditions of use in swine—(1) lon as the only source of drinking Amount. Administer 50 parts per mil- water for 3 to 10 days, depending on the lion (ppm) tylvalosin continuously in severity of the condition being treated. drinking water for 5 consecutive days. (ii) Indications for use. (A) For the (2) Indications for use. For control of treatment and control of swine dys- porcine proliferative enteropathy entery associated with Brachyspira (PPE) associated with Lawsonia hyodysenteriae when followed imme- intracellularis infection in groups of diately by tylosin phosphate medicated swine in buildings experiencing an out- feed; and for the control of porcine pro- break of PPE; and for control of swine liferative enteropathies (PPE, ileitis) respiratory disease (SRD) associated associated with Lawsonia intracellularis with Bordetella bronchiseptica, when followed immediately by tylosin Haemophilus parasuis, Pasteurella phosphate medicated feed. multocida, and Streptococcus suis in (B) For the treatment and control of groups of swine in buildings experi- swine dysentery associated with encing an outbreak of SRD. Brachyspira hyodysenteriae. (3) Limitations. Federal law restricts (iii) Limitations. Do not administer this drug to use by or on the order of a within 48 hours of slaughter. As indi- licensed veterinarian. cated in paragraph (d)(3)(ii)(A) of this [77 FR 55415, Sept. 10, 2012, as amended at 83 section, follow with tylosin phosphate FR 13635, Mar. 30, 2018] medicated feed as in § 558.625(f)(1)(vi)(c) of this chapter. PART 522—IMPLANTATION OR (4) Honey bees—(i) Amount. Mix 200 INJECTABLE DOSAGE FORM NEW milligrams tylosin in 20 grams confec- ANIMAL DRUGS tioners’/powdered sugar. Use immediately. Apply (dust) this mixture over Sec. the top bars of the brood chamber once 522.23 Acepromazine. weekly for 3 weeks. 522.52 Alfaxalone. (ii) Indications for use. For the control 522.56 Amikacin. of American foulbrood (Paenibacillus 522.62 Aminopentamide. larvae). 522.82 Aminopropazine. (iii) Limitations. The drug should be 522.84 Beta-aminopropionitrile. 522.88 Amoxicillin. fed early in the spring or fall and con- 522.90 Ampicillin injectable dosage forms. sumed by the bees before the main 522.90a Ampicillin trihydrate suspension. honey flow begins, to avoid contamina- 522.90b Ampicillin trihydrate powder for in- tion of production honey. Complete jection. treatments at least 4 weeks before 522.90c Ampicillin sodium. main honey flow. 522.144 Arsenamide. 522.147 Atipamezole. [40 FR 13838, Mar. 27, 1975, as amended at 50 522.150 Azaperone. FR 49841, Dec. 5, 1985; 59 FR 14365, Mar. 28, 522.161 Betamethasone. 1994; 62 FR 39443, July 23, 1997; 68 FR 24879, 522.163 Betamethasone dipropionate and May 9, 2003; 70 FR 69439, Nov. 16, 2005; 73 FR betamethasone sodium phosphate aque- 76946, Dec. 18, 2008; 75 FR 76259, Dec. 8, 2010; ous suspension. 76 FR 59024, Sept. 23, 2011; 77 FR 29217, May 522.167 Betamethasone sodium phosphate 17, 2012; 79 FR 37620, July 2, 2014; 79 FR 53136, and betamethasone acetate. Sept. 8, 2014; 79 FR 64116, Oct. 28, 2014; 80 FR 522.204 Boldenone. 34278, June 16, 2015; 83 FR 14587, Apr. 5, 2018; 522.224 Bupivacaine. 84 FR 8973, Mar. 13, 2019; 84 FR 32992, July 11, 522.230 Buprenorphine. 2019] 522.234 Butamisole. 522.246 Butorphanol. § 520.2645 Tylvalosin. 522.275 N-Butylscopolammonium. 522.304 Carprofen. (a) Specifications. Granules containing 522.311 Cefovecin. 62.5 percent tylvalosin (w/w) as 522.313 Ceftiofur injectable dosage forms. tylvalosin tartrate. 522.313a Ceftiofur crystalline free acid.

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522.313b Ceftiofur hydrochloride. 522.1086 Guaifenesin solution. 522.313c Ceftiofur sodium. 522.1125 Hemoglobin glutamer-200 (bovine). 522.380 Chloral hydrate, pentobarbital, and 522.1145 Hyaluronate. magnesium sulfate. 522.1150 Hydrochlorothiazide. 522.390 Chloramphenicol. 522.1155 Imidocarb powder for injection. 522.454 Clodronate. 522.1156 Imidocarb solution. 522.460 Cloprostenol. 522.1160 Insulin. 522.468 Colistimethate sodium powder for 522.1182 Iron injection. injection. 522.1185 Isoflupredone. 522.480 Corticotropin. 522.1192 Ivermectin. 522.518 Cupric glycinate injection. 522.1193 Ivermectin and clorsulon. 522.522 Danofloxacin. 522.1204 Kanamycin. 522.533 Deslorelin. 522.1222 Ketamine. 522.535 Desoxycorticosterone. 522.1223 Ketamine, promazine, and 522.536 Detomidine. aminopentamide. 522.540 Dexamethasone solution. 522.1225 Ketoprofen. 522.542 Dexamethasone suspension. 522.1242 Levamisole. 522.558 Dexmedetomidine. 522.1260 Lincomycin. 522.563 Diatrizoate. 522.1289 Lufenuron. 522.650 Dihydrostreptomycin sulfate injec- 522.1290 Luprostiol. tion. 522.1315 Maropitant. 522.690 Dinoprost. 522.1335 Medetomidine. 522.723 Diprenorphine. 522.1350 Melatonin implant. 522.728 Dipyrone. 522.1362 Melarsomine powder for injection. 522.770 Doramectin. 522.1367 Meloxicam. 522.775 Doxapram. 522.1372 Mepivacaine. 522.784 Doxylamine. 522.1380 Methocarbamol. 522.800 Droperidol and fentanyl. 522.1410 Methylprednisolone. 522.810 Embutramide, chloroquine, and lido- 522.1450 Moxidectin solution. caine solution. 522.1451 Moxidectin microspheres for injec- 522.812 Enrofloxacin. tion. 522.814 Eprinomectin. 522.1452 Nalorphine. 522.820 Erythromycin. 522.1465 Naltrexone. 522.840 Estradiol. 522.1468 Naproxen for injection. 522.842 Estradiol benzoate and testosterone 522.1484 Neomycin. propionate. 522.1503 Neostigmine. 522.850 Estradiol valerate and norgestomet 522.1610 Oleate sodium. in combination. 522.1620 Orgotein for injection. 522.863 Ethylisobutrazine. 522.1660 Oxytetracycline injectable dosage 522.870 Etodolac. forms. 522.883 Etorphine. 522.1660a Oxytetracycline solution, 200 mil- 522.914 Fenprostalene. ligrams/milliliter. 522.930 Firocoxib. 522.1660b Oxytetracycline solution, 300 mil- 522.955 Florfenicol. ligrams/milliliter. 522.956 Florfenicol and flunixin. 522.1662 Oxytetracycline hydrochloride im- 522.960 Flumethasone injectable dosage plantation or injectable dosage forms. forms. 522.1662a Oxytetracycline hydrochloride in- 522.960a Flumethasone suspension. jection. 522.960b Flumethasone acetate solution. 522.1662b Oxytetracycline hydrochloride 522.960c Flumethasone solution. with lidocaine injection. 522.970 Flunixin. 522.1662 Oxytetracycline and flunixin. 522.995 Fluprostenol. 522.1680 Oxytocin. 522.1002 Follicle stimulating hormone. 522.1684 Pegbovigrastim. 522.1010 Furosemide. 522.1696 Penicillin G procaine injectable 522.1014 Gamithromycin. dosage forms. 522.1020 Gelatin. 522.1696a Penicillin G benzathine and peni- 522.1044 Gentamicin. cillin G procaine suspension. 522.1055 Gleptoferron. 522.1696b Penicillin G procaine aqueous sus- 522.1066 Glycopyrrolate. pension. 522.1077 Gonadorelin. 522.1696c Penicillin G procaine in oil. 522.1079 Serum gonadotropin and chorionic 522.1697 Pentobarbital and phenytoin. gonadotropin. 522.1698 Pentazocine. 522.1081 Chorionic gonadotropin for injec- 522.1704 Pentobarbital. tion; chorionic gonadotropin suspension. 522.1720 Phenylbutazone. 522.1083 Gonadotropin releasing factor ana- 522.1820 Pituitary luteinizing hormone pow- log-diphtheria toxoid conjugate. der for injection. 522.1085 Guaifenesin powder for injection. 522.1850 Polysulfated glycosaminoglycan.

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522.1862 Pralidoxime powder for injection. (b) Sponsors. See Nos. 000010 and 522.1870 Praziquantel. 000859 in § 510.600(c) of this chapter: 522.1881 Prednisolone acetate. (c) Conditions of use in dogs, cats, and 522.1883 Prednisolone sodium phosphate. horses—(1) Amount. Dogs: 0.25 to 0.5 mg 522.1884 Prednisolone sodium succinate. per pound (/lb) of body weight; Cats: 0.5 522.1885 Prednisolone tertiary butylacetate. 522.1890 Sterile prednisone suspension. to 1.0 mg/lb of body weight; Horses: 2.0 522.1920 Prochlorperazine and isopropamide. to 4.0 mg per 100 lbs of body weight. 522.1940 Progesterone and estradiol ben- (2) Indications for use. For use as a zoate. tranquilizer and as a preanesthetic 522.1962 Promazine. agent. 522.2002 Propiopromazine. (3) Limitations. Do not use in horses 522.2005 Propofol. intended for human consumption. Fed- 522.2012 Prostalene. eral law restricts this drug to use by or 522.2063 Pyrilamine. on the order of a licensed veterinarian. 522.2075 Robenacoxib. 522.2076 Romifidine. [75 FR 10167, Mar. 5, 2010; 78 FR 17597, Mar. 22, 522.2092 Secobarbital and dibucaine. 2013; 79 FR 16182, Mar. 25, 2014] 522.2100 Selenium and vitamin E. 522.2112 Sometribove zinc suspension. § 522.52 Alfaxalone. 522.2120 Spectinomycin dihydrochloride in- (a) Specifications. Each milliliter con- jection. tains 10 milligrams (mg) alfaxalone. 522.2121 Spectinomycin sulfate. (b) Sponsor. See No. 049480 in 522.2150 Stanozolol. 522.2200 Sulfachlorpyridazine. § 510.600(c) of this chapter. 522.2220 Sulfadimethoxine. (c) Conditions of use in cats and dogs— 522.2240 Sulfaethoxypyridazine. (1) Amount—(i) Cats—(A) Induction of 522.2260 Sulfamethazine. general anesthesia. Administer by intra- 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. a preanesthetic or 1.0 to 10.8 mg/kg for 522.2444a Thiopental powder for injection. 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. 3 to 5 minutes anesthesia in 522.2477 Trenbolone acetate and estradiol. 522.2478 Trenbolone acetate and estradiol unpreanesthetized cats. benzoate. (ii) Dogs—(A) Induction of general an- 522.2483 Triamcinolone. esthesia. Administer by intravenous in- 522.2582 Triflupromazine. jection over approximately 60 seconds 522.2610 Trimethoprim and sulfadiazine. or until clinical signs show the onset of 522.2615 Tripelennamine. anesthesia, 1.5 to 4.5 mg/kg for dogs 522.2630 Tulathromycin. that did not receive a preanesthetic or 522.2640 Tylosin. 0.2 to 3.5 mg/kg for dogs that received 522.2662 Xylazine. a preanesthetic. 522.2670 Yohimbine. 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

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and for induction of anesthesia fol- (3) Limitations. Federal law restricts lowed by maintenance with an inhalant this drug to use by or on the order of a anesthetic, in dogs and cats. licensed veterinarian. (3) Limitations. Federal law restricts this drug to use by or on the order of a [79 FR 16183, Mar. 25, 2014] licensed veterinarian. Alfaxalone is a Class IV controlled substance. § 522.82 Aminopropazine. (a) Specifications. Each milliliter of [77 FR 64717, Oct. 23, 2012, as amended at 79 FR 64116, Oct. 28, 2014] solution contains aminopropazine fumarate equivalent to 25 milligrams § 522.56 Amikacin. (mg) aminopropazine base. (a) Specifications. Each milliliter of (b) Sponsor. See No. 000061 in solution contains 50 milligrams (mg) of § 510.600(c) of this chapter. amikacin as amikacin sulfate. (c) Conditions of use—(1) Dogs and (b) Sponsor. See No. 069043 in cats—(i) Amount. 1 to 2 mg per pound of § 510.600(c) of this chapter. body weight, repeated every 12 hours as (c) Conditions of use in dogs—(1) indicated, by intramuscular or intra- Amount. 5 mg/pound (lb) of body weight venous injection. twice daily by intramuscular or sub- (ii) Indications for use. For reducing cutaneous injection. excessive smooth muscle contractions, (2) Indications for use. For treatment such as occur in urethral spasms asso- of genitourinary tract infections (cys- ciated with urolithiasis. titis) caused by susceptible strains of Escherichia coli and Proteus spp. and (iii) Limitations. Federal law restricts skin and soft tissue infections caused this drug to use by or on the order of a by susceptible strains of Pseudomonas licensed veterinarian. spp. and E. coli. (2) Horses—(i) Amount. Administer (3) Limitations. Do not use in horses 0.25 mg per pound of body weight, re- intended for human consumption. Fed- peated every 12 hours as indicated, by eral law restricts this drug to use by or intramuscular or intravenous injec- on the order of a licensed veterinarian. tion. [76 FR 17338, Mar. 29, 2011, as amended at 78 (ii) Indications for use. For reducing FR 17597, Mar. 22, 2013; 79 FR 16183, Mar. 25, excessive smooth muscle contractions, 2014; 81 FR 17608, Mar. 30, 2016] such as occur in colic spasms. (iii) Limitations. Do not use in horses § 522.62 Aminopentamide. intended for human consumption. Fed- (a) Specifications. Each milliliter of eral law restricts this drug to use by or solution contains 0.5 milligram (mg) on the order of a licensed veterinarian. aminopentamide hydrogen sulfate. (b) Sponsor. See No. 054771 in [79 FR 16183, Mar. 25, 2014] § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— § 522.84 Beta-aminopropionitrile. (1) Amount. Administer by subcuta- (a) Specifications. The drug is a sterile neous or intramuscular injection every powder. Each milliliter of constituted 8 to 12 hours as follows: For animals solution contains 0.7 milligrams (mg) weighing up to 10 pounds (lbs): 0.1 mg; beta-aminopropionitrile fumarate. For animals weighing 11 to 20 lbs: 0.2 (b) Sponsor. See No. 064146 in mg; For animals weighing 21 to 50 lbs: § 510.600(c) of this chapter. 0.3 mg; For animals weighing 51 to 100 (c) Conditions of use in horses—(1) lbs: 0.4 mg; For animals weighing over 100 lbs: 0.5 mg. Dosage may be gradu- Amount. Administer 7 mg by ally increased up to a maximum of five intralesional injection every other day times the suggested dosage. Following for five treatments beginning about 30 parenteral use, dosage may be contin- days after initial injury. ued by oral administration of tablets. (2) Indications for use in horses. For (2) Indications for use. For the treat- treatment of tendinitis of the super- ment of vomiting and/or diarrhea, nau- ficial digital flexor tendon (SDFT) in sea, acute abdominal visceral spasm, horses where there is sonographic evi- pylorospasm, or hypertrophic gastritis. dence of fiber tearing.

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(3) Limitations. Do not use in horses tions (abscesses, lacerations, and intended for human consumption. Fed- wounds) due to S. aureus, Staphy- eral law restricts this drug to use by or lococcus spp., Streptococcus spp., E. coli, on the order of a licensed veterinarian. and Pasteurella multocida. [79 FR 16183, Mar. 25, 2014] (iii) Limitations. Federal law restricts this drug to use by or on the order of a § 522.88 Amoxicillin. licensed veterinarian. (a) Specifications—(1) Each vial con- (2) Cattle—(i) Amount. Administer 3 to tains 3 grams (g) of amoxicillin tri- 5 mg per pound of body weight daily for hydrate. Each milliliter of constituted up to 5 days by intramuscular or sub- suspension contains 100 or 250 milli- cutaneous injection. grams (mg) amoxicillin trihydrate for (ii) Indications for use. For treatment use as in paragraph (d)(1) of this sec- of diseases due to amoxicillin-suscep- tion. tible organisms as follows: Respiratory (2) Each vial contains 25 g of tract infections (shipping fever, pneu- amoxicillin trihydrate. Each milliliter monia) due to P. multocida, P. of constituted suspension contains 250 hemolytica, Haemophilus spp., Staphy- mg amoxicillin trihydrate for use as in lococcus spp., and Streptococcus spp. and paragraph (d)(2) of this section. acute necrotic pododermatitis (foot (b) Sponsor. See No. 054771 in rot) due to Fusobacterium necrophorum. § 510.600(c) of this chapter. (iii) Limitations. Treated animals (c) Related tolerance. See § 556.38 of must not be slaughtered for food dur- this chapter. ing treatment and for 25 days after the (d) Conditions of use—(1) Dogs and last treatment. Milk from treated cows cats—(i) Amount. Administer 5 mg per must not be used for human consump- pound of body weight daily for up to 5 tion during treatment or for 96 hours (8 days by intramuscular or subcutaneous milkings) after last treatment. Federal injection. law restricts this drug to use by or on (ii) Indications for use—(A) Dogs. For the order of a licensed veterinarian. treatment of infections caused by susceptible strains of organisms as fol- [79 FR 16183, Mar. 25, 2014] lows: Respiratory infections (tonsillitis, tracheobronchitis) due to Staphy- § 522.90 Ampicillin injectable dosage forms. lococcus aureus, Streptococcus spp., Esch- erichia coli, and Proteus mirabilis; geni- [79 FR 16183, Mar. 25, 2014] tourinary infections (cystitis) due to S. aureus, Streptococcus spp., E. coli, and P. § 522.90a Ampicillin trihydrate suspen- mirabilis; gastrointestinal infections sion. (bacterial gastroenteritis) due to S. 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.

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(d) Conditions of use—(1) Cattle—(i) Streptococcus spp., and E. coli, when Amount. For enteritis: 3 mg per pound caused by susceptible organisms. of body weight, intramuscularly, once (iii) Limitations. Federal law restricts or twice daily, for up to 3 days. For this drug to use by or on the order of a pneumonia: 3 mg per pound of body licensed veterinarian. weight, intramuscularly, twice daily, (4) Cats—(i) Amount. 5 to 10 mg per for up to 3 days. pound of body weight by intramuscular (ii) Indications for use. For treatment or subcutaneous injection, once or of bacterial enteritis in calves caused twice daily. Usual treatment is 3 to 5 by Escherichia coli and bacterial pneu- days. monia caused by Pasteurella spp. sus- (ii) Indications for use. Treatment of ceptible to ampicillin. generalized infections (septicemia) as- (iii) Limitations. Treated animals sociated with abscesses, lacerations, must not be slaughtered for food use and wounds due to Staphylococcus spp., during treatment or for 9 days after Streptococcus spp., and Pasteurella spp. the last treatment. Federal law re- (iii) 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. (2) Swine—(i) Amount. 3 mg per pound of body weight by intramuscular injec- [79 FR 16183, Mar. 25, 2014] tion, once or twice daily, for up to 3 § 522.90b Ampicillin trihydrate powder days. for injection. (ii) Indications for use. Treatment of bacterial enteritis (colibacillosis) (a) Specifications. Each milliliter of caused by E. coli and bacterial pneu- aqueous suspension constituted from monia caused by Pasteurella spp. sus- ampicillin trihydrate powder contains ceptible to ampicillin. 200, 250, or 400 milligrams (mg) ampi- (iii) Limitations. Treated animals cillin equivalents. must not be slaughtered for food use (b) Sponsors. See Nos. 000010 and during treatment or for 15 days after 042791 in § 510.600(c) of this chapter. the last treatment. Federal law re- (c) Related tolerances. See § 556.40 of stricts this drug to use by or on the this chapter. order of a licensed veterinarian. (d) Conditions of use—(1) Dogs and (3) Dogs—(i) Amount—(A) 3 to 6 mg cats—(i) Amount. 3 mg/pound (lb) of per pound of body weight by body weight twice daily by subcuta- intramuscular injection, once or twice neous or intramuscular injection. daily. Usual treatment is 3 to 5 days. (ii) Indications for use. For treatment (B) 3 to 5 mg of ampicillin per pound of strains of organisms susceptible to of body weight, once a day for up to 4 ampicillin and associated with res- days. piratory tract infections, urinary tract (ii) Indications for use—(A) Treatment infections, gastrointestinal infections, of respiratory tract infections due to E. skin infections, soft tissue infections, coli, Pseudomonas spp., Proteus spp., and postsurgical infections. Staphylococcus spp., and Streptococcus (iii) Limitations. Federal law restricts spp.; tonsillitis due to E. coli, this drug to use by or on the order of a Pseudomonas spp., Streptococcus spp., licensed veterinarian. and Staphylococcus spp.; generalized in- (2) Cattle—(i) Amount. 2 to 5 mg/lb of fections (septicemia) associated with body weight once daily by abscesses, lacerations, and wounds due intramuscular injection. to Staphylococcus spp. and Streptococcus (ii) Indications for use. For treatment spp. of respiratory tract infections caused (B) Treatment of bacterial infections by organisms susceptible to ampicillin, of the upper respiratory tract (tonsil- bacterial pneumonia (shipping fever, litis) due to Streptococcus spp., Staphy- calf pneumonia, and bovine pneu- lococcus spp., E. coli, Proteus spp., and monia) caused by Aerobacter spp., Pasteurella spp., and soft tissue infec- Klebsiella spp., Staphylococcus spp., tions (abscesses, lacerations, and Streptococcus spp., Pasteurella multocida, wounds) due to Staphylococcus spp., and Escherichia coli.

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(iii) Limitations. Do not treat cattle worm disease caused by Dirofilaria for more than 7 days. Milk from treat- immitis. ed cows must not be used for food dur- (3) 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 [79 FR 16184, Mar. 25, 2014, as amended at 84 FR 39183, Aug. 9, 2019] days) after the last treatment. Federal law restricts this drug to use by or on § 522.147 Atipamezole. the order of a licensed veterinarian. (a) Specifications. Each milliliter of [57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept. solution contains 5.0 milligrams 15, 1992; 58 FR 18304, Apr. 8, 1993; 63 FR 41420, atipamezole hydrochloride. Aug. 4, 1998; 75 FR 10167, Mar. 5, 2010; 76 FR 17338, Mar. 29, 2011; 76 FR 53051, Aug. 25, 2011; (b) Sponsor. See Nos. 015914 and 052483 82 FR 21690, May 10, 2017; 85 FR 4208, Jan. 24, in § 510.600(c) of this chapter. 2020] (c) Conditions of use in dogs—(1) Amount. Inject intramuscularly the § 522.90c Ampicillin sodium. same volume as that of (a) Specifications. Each milliliter of dexmedetomidine or medetomidine aqueous solution constituted from am- used. picillin sodium powder contains 300 (2) Indications for use. For reversal of milligrams (mg) ampicillin equiva- the sedative and analgesic effects of lents. dexmedetomidine hydrochloride or (b) Sponsors. See Nos. 010515 and medetomidine hydrochloride. 054771 in § 510.600(c) of this chapter. (3) Limitations. Federal law restricts (c) Conditions of use in horses—(1) this drug to use by or on the order of a Amount: 3 mg per pound of body weight licensed veterinarian. twice daily by intravenous or intramuscular injection. [61 FR 48830, Sept. 17, 1996, as amended at 64 FR 71640, Dec. 22, 1999; 72 FR 264, Jan. 4, 2007; (2) Indications for use. For the treat- 84 FR 8973, Mar. 13, 2019] ment of respiratory tract infections (pneumonia and strangles) due to § 522.150 Azaperone. Staphylococcus spp., Streptococcus spp. (a) Each milliliter of (including S. equi), Escherichia coli, and Specifications. solution contains 40 milligrams (mg) Proteus mirabilis, and skin and soft tissue infections (abscesses and wounds) azaperone. due to Staphylococcus spp., Streptococcus (b) Sponsor. See No. 058198 in spp., E. coli, and P. mirabilis, when § 510.600(c) of this chapter. caused by susceptible organisms. (c) Related tolerances. See § 556.68 of (3) Limitations. Do not use in horses this chapter. intended for human consumption. Fed- (d) Conditions of use—(1) Indications eral law restricts this drug to use by or for use. For control of aggressiveness on the order of a licensed veterinarian. when mixing or regrouping weanling or feeder pigs weighing up to 80 pounds. [72 FR 45158, Aug. 13, 2007, as amended at 79 (2) Dosage. 2.2 mg per kilogram (1 mg FR 16184, Mar. 25, 2014] per pound) by deep intramuscular in- § 522.144 Arsenamide. jection. (3) Limitations. Federal law restricts (a) Specifications. Each milliliter of this drug to use by or on the order of a solution contains 10.0 milligrams licensed veterinarian. arsenamide sodium. (b) Sponsor. See No. 000010 in [74 FR 65689, Dec. 11, 2009, as amended at 77 § 510.600(c) of this chapter. FR 46613, Aug. 6, 2012; 81 FR 48702, July 26, (c) Conditions of use in dogs—(1) 2016; 84 FR 32992, July 11, 2019] Amount. Administer 0.1 milliliter (mL) per pound of body weight (1.0 mL for § 522.161 Betamethasone. every 10 pounds) by intravenous injec- (a) Specifications. Each milliliter of tion twice a day for 2 days. suspension contains: (2) Indications for use. For the treat- (1) Betamethasone acetate equivalent ment and prevention of canine heart- to 10.8 milligrams (mg) betamethasone

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and betamethasone disodium phos- equivalent of 5 milligrams of phate equivalent to 3 mg of betamethasone as betamethasone betamethasone. dipropionate and 2 milligrams of (2) Betamethasone dipropionate betamethasone as betamethasone so- equivalent to 5 mg betamethasone and dium phosphate. betamethasone sodium phosphate (b) Sponsor. See No. 000061 in equivalent to 2 mg of betamethasone. § 510.600(c) of this chapter. (b) Sponsor. See sponsor numbers in (c) Conditions of use—(1) Dogs. (i) It is § 510.600(c) of this chapter: used as an aid in the control of pru- (1) No. 000061 for product described in ritus associated with dermatoses. paragraph (a)(1) of this section for use (ii) It is administered by as in paragraphs (c)(1), (c)(2)(i), intramuscular injection at a dosage of (c)(2)(ii)(A), and (c)(2)(iii) of this sec- 0.25 to 0.5 milliliter per 20 pounds of tion. body weight, depending on the severity (2) No. 000061 for product described in of the condition. Frequency of dosage paragraph (a)(2) of this section for use depends on recurrence of pruritic as in paragraphs (c)(1), (c)(2)(i), symptoms. Dosage may be repeated (c)(2)(ii)(B), and (c)(2)(iii) of this sec- every 3 weeks or when symptoms recur, tion. not to exceed a total of 4 injections. (c) Conditions of use—(1) Dogs—(i) (2) Horses. (i) It is used as an aid in Amount. Administer by intramuscular the control of inflammation associated injection 0.25 to 0.5 milliliter (mL) per with various arthropathies. 20 pounds of body weight, depending on (ii) It is administered aseptically by the severity of the condition. Fre- intraarticular injection at a dosage of quency of dosage depends on recurrence 2.5 to 5 milliliters per joint, depending of pruritic symptoms. Dosage may be on the severity of the condition and repeated every 3 weeks or when symp- the joint size. Dosage may be repeated toms recur, not to exceed a total of upon recurrence of clinical signs. Injec- four injections. tion into the joint cavity should be (ii) Indications for use. As an aid in preceded by withdrawal of synovial the control of pruritus associated with fluid. dermatoses. (iii) Not for use in horses intended for (iii) Limitations. Federal law restricts food. this drug to use by or on the order of a (3) Clinical and experimental data. It licensed veterinarian. has been demonstrated that (2) Horses—(i) Amount. Administer 2.5 corticosteroids administered orally or to 5 mL by intra-articular injection. parenterally to animals may induce (ii) Indications for use—(A) For the the first stage of parturition when ad- treatment of various inflammatory ministered during the last trimester of joint conditions; for example, acute pregnancy and may precipitate pre- and traumatic lameness involving the mature parturition followed by carpel and fetlock joints. dystocia, fetal death, retained pla- (B) As an aid in the control of inflam- centa, and metritis. mation associated with various (4) Restrictions. Federal law restricts arthropathies. this drug to use by or on the order of a (iii) Limitations. Do not use in horses licensed veterinarian. intended for human consumption. Fed- eral law restricts this drug to use by or [40 FR 13858, Mar. 27, 1975, as amended at 41 FR 27316, July 2, 1976; 52 FR 7832, Mar. 13, on the order of a licensed veterinarian. 1987] [79 FR 16184, Mar. 25, 2014] § 522.167 Betamethasone sodium phos- § 522.163 Betamethasone dipropionate phate and betamethasone acetate. and betamethasone sodium phos- (a) Specifications. Each milliliter phate aqueous suspension. (mL) of suspension contains 6 milli- (a) Specifications. Betamethasone grams (mg) betamethasone (3.15 mg dipropionate and betamethasone so- betamethasone sodium phosphate and dium phosphate aqueous suspension is 2.85 mg betamethasone acetate). a sterile aqueous suspension. Each mil- (b) Sponsor. See No. 010797 in liliter of the suspension contains the § 510.600(c) of this chapter.

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(c) Conditions of use in horses—(1) (ii) Indications for use. For use as a Amount. Administer 1.5 mL (9 mg total peripheral nerve block to provide re- betamethasone) per joint by intra-ar- gional postoperative analgesia fol- ticular injection. May be administered lowing onychectomy. concurrently in up to two joints per [81 FR 67151, Sept. 30, 2016, as amended at 84 horse. FR 8973, Mar. 13, 2019; 85 FR 4208, Jan. 24, (2) Indications for use. For the control 2020] of pain and inflammation associated with osteoarthritis in horses. § 522.230 Buprenorphine. (3) Limitations. Do not use in horses (a) Specifications. Each milliliter of intended for human consumption. Fed- solution contains 1.8 milligrams (mg) eral law restricts this drug to use by or buprenorphine. on the order of a licensed veterinarian. (b) Sponsor. See No. 054771 in [80 FR 18776, Apr. 8, 2015] § 510.600(c) of this chapter. (c) Conditions of use in cats—(1) § 522.204 Boldenone. Amount. Administer 0.24 mg per kilogram (0.11 mg per pound) by subcuta- (a) Specifications. Each milliliter of neous injection once daily, for up to 3 solution contains 25 or 50 milligrams days. Administer the first dose ap- (mg) boldenone undecylenate. proximately 1 hour prior to surgery. (b) Sponsor. See No. 054771 in (2) Indications for use. For the control § 510.600(c) of this chapter. of postoperative pain associated with (c) Conditions of use in horses—(1) surgical procedures in cats. Amount. 0.5 mg per pound body weight (3) Limitations. Federal law restricts by intramuscular injection. Treatment this drug to use by or on the order of a may be repeated at 3-week intervals. licensed veterinarian. (2) Indications for use. As an aid for [79 FR 53136, Sept. 8, 2014, as amended at 80 treating debilitated horses when an im- FR 18776, Apr. 8, 2015] provement in weight, hair coat, or general physical condition is desired. § 522.234 Butamisole. (3) Limitations. Do not administer to (a) Specifications. Each milliliter of horses intended for human consump- solution contains 11 milligrams (mg) tion. Federal law restricts this drug to butamisole hydrochloride. use by or on the order of a licensed vet- (b) Sponsors. See Nos. 000859 and erinarian. 054771 in § 510.600(c) of this chapter. [70 FR 70998, Nov. 25, 2005, as amended at 79 (c) Conditions of use in dogs—(1) FR 16184, Mar. 25, 2014] Amount. Administer 0.1 mg per pound of body weight by subcutaneous injec- § 522.224 Bupivacaine. tion. In problem cases, retreatment for (a) Specifications. Each milliliter whipworms may be necessary in ap- (mL) of liposomal suspension contains proximately 3 months. For hookworms, 13.3 milligrams (mg) bupivacaine. a second injection should be given 21 (b) Sponsor. See No. 058198 in days after the initial treatment. § 510.600(c) of this chapter. (2) Indications for use. For the treat- (c) Conditions of use—(1) Dogs—(i) ment of infections with whipworms Amount. Administer 5.3 mg/kg (0.4 mL/ (Trichuris vulpis), and the hookworm kg) by infiltration injection into the (Ancylostoma caninum). tissue layers at the time of incisional (3) Limitations. Federal law restricts closure. this drug to use by or on the order of a licensed veterinarian. (ii) Indications for use. For single-dose infiltration into the surgical site to [79 FR 16184, Mar. 25, 2014] provide local postoperative analgesia for cranial cruciate ligament surgery. § 522.246 Butorphanol. (2) Cats—(i) Amount. Administer 5.3 (a) Specifications. Each milliliter of mg/kg per forelimb (0.4 mL/kg per solution contains butorphanol (as forelimb), for a total dose of 10.6 mg/kg/ butorphanol tartrate) in the following cat, as a 4-point nerve block prior to amounts: onychectomy. (1) 0.5 milligrams (mg);

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(2) 2 mg; or (iii) Limitations. Do not use in horses (3) 10 mg intended for human consumption. (b) Sponsors. See sponsors in [72 FR 27957, May 18, 2007, as amended at 73 § 510.600(c) of this chapter as follows: FR 31358, June 2, 2008; 74 FR 61516, Nov. 25, (1) No. 054771 for use of the product 2009; 75 FR 22524, Apr. 29, 2010; 77 FR 60302, described in paragraph (a)(1) as in para- Oct. 3, 2012; 78 FR 17597, Mar. 22, 2013; 79 FR graph (d)(1) of this section; for use of 16184, Mar. 25, 2014; 79 FR 74020, Dec. 15, 2014; the product described in paragraph 80 FR 13229, Mar. 13, 2015] (a)(2) as in paragraph (d)(2) of this section; and for use of the product de- § 522.275 N-Butylscopolammonium. scribed in paragraph (a)(3) as in para- (a) Specifications. Each milliliter of graph (d)(3) of this section. solution contains 20 milligrams (mg) (2) No. 000859 for use of the product N-butylscopolammonium bromide. described in paragraph (a)(2) as in para- (b) Sponsor. See No. 000010 in graph (d)(2) of this section. § 510.600(c) of this chapter. (3) Nos. 000061, 000859, and 059399 for (c) Conditions of use in horses—(1) use of the product described in para- Amount. 0.3 mg per kilogram of body graph (a)(3) as in paragraph (d)(3) of weight (0.14 mg per pound) slowly in- this section. travenously. (c) Special considerations. Federal law (2) Indications for use. For the control restricts this drug to use by or on the of abdominal pain (colic) associated order of a licensed veterinarian. with spasmodic colic, flatulent colic, (d) Conditions of use—(1) Dogs—(i) and simple impactions. Amount. Administer 0.025 mg per pound (3) Limitations. Federal law restricts of body weight by subcutaneous injec- this drug to use by or on the order of a tion at intervals of 6 to 12 hours, as re- licensed veterinarian. quired. If necessary, increase dose to a [69 FR 35512, June 25, 2004] maximum of 0.05 mg per pound of body weight. Treatment should not nor- § 522.304 Carprofen. mally be required for longer than 7 (a) Specifications. Each milliliter of days. solution contains 50 milligrams (mg) (ii) Indications for use. For the relief carprofen. of chronic nonproductive cough associ- (b) Sponsors. See Nos. 016729, 026637, ated with tracheo-bronchitis, tra- 054771, and 055529 in § 510.600(c) of this cheitis, tonsillitis, laryngitis, and chapter. pharyngitis associated with inflam- (c) [Reserved] matory conditions of the upper res- (d) Conditions of use in dogs—(1) piratory tract. Amount. 2 mg/lb (4.4 mg/kg) body (2) Cats—(i) Amount. Administer 0.2 weight once daily or 1 mg/lb (2.2 mg/kg) mg per pound of body weight by sub- twice daily, by subcutaneous injection. cutaneous injection. Dose may be re- For the control of postoperative pain, peated up to 4 times per day. Do not administer approximately 2 hours be- treat for more than 2 days. fore the procedure. (ii) Indications for use. For the relief (2) Conditions of use. For the relief of of pain in cats caused by major or pain and inflammation associated with minor trauma, or pain associated with osteoarthritis and for the control of surgical procedures. postoperative pain associated with soft (3) Horses—(i) Amount. Administer tissue and orthopedic surgeries. 0.05 mg per pound of body weight by in- (3) Limitations. Federal law restricts travenous injection. Dose may be re- this drug to use by or on the order of a peated within 3 to 4 hours. Treatment licensed veterinarian. should not exceed 48 hours. [68 FR 26205, May 15, 2003, as amended at 68 (ii) Indications for use. For the relief FR 34796, June 11, 2003; 68 FR 49351, Aug. 18, of pain associated with colic and 2003. Redesignated at 73 FR 29685, May 22, postpartum pain in adult horses and 2008, as amended at 79 FR 74020, Dec. 15, 2014; yearlings. 82 FR 43484, Sept. 18, 2017]

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§ 522.311 Cefovecin. pleuropneumoniae, Pasteurella multocida, (a) Specifications. Each milliliter of Haemophilus parasuis, and Streptococcus constituted solution contains 80 milli- suis. For the control of SRD associated grams (mg) cefovecin as the sodium with A. pleuropneumoniae, P. multocida, salt. H. parasuis, and S. suis in groups of pigs (b) Sponsor. See No. 054771 in where SRD has been diagnosed. § 510.600(c) of this chapter. (iii) Limitations. Following label use (c) Special considerations. Federal law as a single treatment, a 14-day pre- restricts this drug to use by or on the slaughter withdrawal period is re- order of a licensed veterinarian. quired. Federal law restricts this drug (d) Conditions of use—(1) Dogs—(i) to use by or on the order of a licensed Amount. Administer 3.6 mg/pound (lb) (8 veterinarian. Federal law prohibits mg/kilograms (kg)) body weight as a extra-label use of this drug in swine for single subcutaneous injection. A sec- disease prevention purposes; at unap- ond subcutaneous injection of 3.6 mg/lb proved doses, frequencies, durations, or (8 mg/kg) may be administered if re- routes of administration; and in unap- sponse to therapy is not complete. proved, major food-producing species/ (ii) Indications for use. For the treat- production classes. ment of skin infections (secondary su- (2) Cattle. The formulation described perficial pyoderma, abscesses, and in paragraph (a)(2) of this section is wounds) in dogs caused by susceptible used as follows: strains of Staphylococcus intermedius (i) Amount. For subcutaneous (SC) in- and Streptococcus canis (Group G). jection in the posterior aspect of the (2) Cats—(i) Amount. Administer 3.6 ear where it attaches to the head (base mg/lb (8 mg/kg) body weight as a sin- of the ear) in lactating dairy cattle. gle, one-time subcutaneous injection. For SC injection in the middle third of (ii) Indications for use. For the treat- the posterior aspect of the ear or in the ment of skin infections (wounds and base of the ear in beef and non-lac- abscesses) in cats caused by susceptible tating dairy cattle. strains of Pasteurella multocida. (A) Single-dose regimen: 6.6 mg [73 FR 29685, May 22, 2008, as amended at 79 ceftiofur equivalents per kg of body FR 16185, Mar. 25, 2014] weight as a single injection. (B) Two-dose regimen: 6.6 mg § 522.313 Ceftiofur injectable dosage ceftiofur equivalents per kg of body forms. weight given as two injections in the § 522.313a Ceftiofur crystalline free base of the ear approximately 72 hours acid. apart. (a) Specifications. The product is a (ii) Indications for use—(A) Single- suspension of ceftiofur crystalline free dose regimen: For the treatment of bo- acid. vine respiratory disease (BRD, shipping (1) Each milliliter (mL) contains 100 fever, pneumonia) associated with milligrams (mg) ceftiofur equivalents. Mannheimia haemolytica, Pasteurella (2) Each mL contains 200 mg ceftiofur multocida, and Histophilus somni in beef, equivalents. non-lactating dairy, and lactating (b) Sponsor. See No. 054771 in dairy cattle. For the control of res- § 510.600(c) of this chapter. piratory disease in beef and non-lac- (c) Related tolerances. See § 556.113 of tating dairy cattle which are at high this chapter. risk of developing BRD associated with (d) Conditions of use—(1) Swine. The M. haemolytica, P. multocida, and H. formulation described in paragraph somni. For the treatment of bovine foot (a)(1) of this section is used as follows: rot (interdigital necrobacillosis) asso- (i) Amount. 5.0 mg CE per kilogram ciated with Fusobacterium necrophorum (kg) of body weight by intramuscular and Porphyromonas levii in beef, non- injection in the postauricular region of lactating dairy, and lactating dairy the neck. cattle. (ii) Indications for use. For the treat- (B) Two-dose regimen: For the treatment of swine respiratory disease ment of acute metritis (0-to 10-days (SRD) associated with Actinobacillus postpartum) associated with bacterial

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organisms susceptible to ceftiofur in stearate, sorbitan monooleate, and me- lactating dairy cattle. dium chain triglycerides. (iii) Limitations. Following label use (b) Sponsors. See sponsors in as either a single-dose or 2-dose regi- § 510.600(c) of this chapter as follows: men, a 13-day pre-slaughter withdrawal (1) No. 054771 for products described period is required after the last treat- in paragraphs (a)(1) and (2) of this sec- ment. A withdrawal period has not tion; and been established in preruminating (2) No. 055529 for the product de- calves. Do not use in calves to be proc- scribed in paragraph (a)(3) of this sec- essed for veal. Federal law restricts tion. this drug to use by or on the order of a (c) Related tolerances. See § 556.113 of licensed veterinarian. Federal law pro- this chapter. hibits extra-label use of this drug in (d) Special considerations. Federal law cattle for disease prevention purposes; restricts this drug to use by or on the at unapproved doses, frequencies, dura- order of a licensed veterinarian. Fed- tions, or routes of administration; and eral law prohibits extra-label use of in unapproved, major food-producing this drug in cattle and swine for dis- species/production classes. ease prevention purposes; at unap- (3) Horses. The formulation described proved doses, frequencies, durations, or in paragraph (a)(2) of this section is routes of administration; and in unap- used as follows: proved major food-producing species/ (i) Amount. Two intramuscular injec- production classes. tions, 4 days apart, at a dose of 3.0 mg/ lb (6.6 mg/kg) body weight. (e) Conditions of use—(1) Swine—(i) Amount. 3 to 5 mg per kilogram (/kg) of (ii) Indications for use. For the treat- body weight by intramuscular injec- ment of lower respiratory tract infection. Treatment should be repeated at tions in horses caused by susceptible strains of Streptococcus equi ssp. 24-hour intervals for a total of 3 con- zooepidemicus. secutive days. (iii) Limitations. Do not use in horses (ii) Indications for use. For treatment intended for human consumption. Fed- and control of swine bacterial res- eral law restricts this drug to use by or piratory disease (swine bacterial pneu- on the order of a licensed veterinarian. monia) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, [68 FR 60296, Oct. 22, 2003, as amended at 69 Salmonella Choleraesuis, and Strepto- FR 43892, July 23, 2004. Redesignated and coccus suis. amended at 71 FR 39546, July 13, 2006; 73 FR 58872, Oct. 8, 2008; 75 FR 4692, Jan. 29, 2010; 75 (iii) Limitations. For products de- FR 62468, Oct. 12, 2010; 77 FR 26162, May 3, scribed in paragraphs (a)(1) and (3) of 2012; 79 FR 16185, Mar. 25, 2014; 79 FR 37620, this section: Treated swine must not be July 2, 2014] slaughtered for 4 days following the last treatment. For products described § 522.313b Ceftiofur hydrochloride. in paragraph (a)(2) of this section: (a) Specifications. Each milliliter of Treated swine must not be slaughtered suspension contains: for 6 days following the last treatment (1) Ceftiofur hydrochloride equiva- when injection site volumes are greater lent to 50 milligrams (mg) of ceftiofur than 5 mL up to the maximum injec- equivalents in the inactive vehicles tion site volume of 15 mL. Treated phospholipan 90H, sorbitan swine must not be slaughtered for 4 monooleate, and cottonseed oil; days when injection site volumes are (2) Ceftiofur hydrochloride equiva- less than or equal to 5 mL. lent to 50 mg ceftiofur equivalents in (2) Cattle—(i) Amount. Administer by the inactive vehicles polyoxyethylene subcutaneous or intramuscular injec- sorbitan monooleate (polysorbate 80) in tion as follows: a caprylic/capric triglyceride suspen- (A) For bovine respiratory disease sion; or and acute bovine interdigital (3) Ceftiofur hydrochloride equiva- necrobacillosis: 1.1 to 2.2 mg/kg of body lent to 50 mg ceftiofur equivalents in weight at 24-hour intervals for 3 to 5 the inactive vehicles aluminum mono- consecutive days.

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(B) For bovine respiratory disease: 2.2 (e) Conditions of use—(1) Swine—(i) mg/kg of body weight administered Amount. 3 to 5 mg per kilogram (/kg) twice at a 48 hour interval. body weight by intramuscular injec- (C) For acute metritis: 2.2 mg/kg of tion for 3 consecutive days. body weight at 24-hour intervals for 5 (ii) Indications for use. For treatment consecutive days. and control of swine bacterial res- (ii) Indications for use. For treatment piratory disease (swine bacterial pneu- of bovine respiratory disease (BRD, monia) associated with Actinobacillus shipping fever, pneumonia) associated pleuropneumoniae, Pasteurella multocida, with Mannheimia haemolytica, P. Salmonella choleraesuis, and Strepto- multocida, and Histophilus somni; acute coccus suis. bovine interdigital necrobacillosis (iii) Limitations. Treated pigs must (foot rot, pododermatitis) associated not be slaughtered for 4 days following with Fusobacterium necrophorum and the last treatment. Bacteroides melaninogenicus; and acute (2) Cattle—(i) Amount. 0.5 to 1.0 mg/lb metritis (0 to 14 days post-partum) as- body weight by intramuscular or sub- sociated with bacteria susceptible to cutaneous injection for 3 days. Addi- ceftiofur. tional treatments may be given on (iii) Limitations. (A) For products de- days 4 and 5 for animals which do not scribed in paragraphs (a)(2) and (3) of show satisfactory response. this section: Treated cattle must not (ii) Indications for use. For treatment be slaughtered for 3 days following the of bovine respiratory disease (shipping last treatment. For products described fever, pneumonia) associated with in paragraph (a)(2) of this section: Mannheimia haemolytica, Pasteurella Treated cattle must not be slaughtered multocida, and Histophilus somni. Also, for 4 days following the last treatment. for the treatment of acute bovine (B) A withdrawal period has not been interdigital necrobacillosis (foot rot, established in preruminating calves. pododermatitis) associated with Do not use in calves to be processed for Fusobacterium necrophorum and veal. Bacteroides melaninogenicus. (iii) Limitations. Treated cattle must [61 FR 29479, June 11, 1996, as amended at 63 not be slaughtered for 4 days following FR 53578, Oct. 6, 1998; 67 FR 45901, July 11, 2002; 69 FR 47362, Aug. 5, 2004. Redesignated the last treatment. and amended at 71 FR 39544, July 13, 2006; 73 (3) Sheep—(i) Amount. 0.5 to 1.0 mg/lb FR 45612, Aug. 6, 2008; 76 FR 17338, Mar. 29, body weight by intramuscular injec- 2011; 78 FR 66264, Nov. 5, 2013; 84 FR 39183, tion for 3 days. Additional treatments Aug. 9, 2019; 84 FR 53311, Oct. 7, 2019] may be given on days 4 and 5 for animals which do not show satisfactory § 522.313c Ceftiofur sodium. response. (a) Specifications. Each milliliter of (ii) Indications for use. For treatment aqueous solution constituted from of sheep respiratory disease (sheep ceftiofur sodium powder contains 50 pneumonia) associated with milligrams (mg) ceftiofur equivalents. Mannheimia haemolytica and Pasteurella (b) Sponsors. See Nos. 054771 and multocida. 068330 in § 510.600(c) of this chapter. (4) Goats—(i) Amount. 0.5 to 1.0 mg/lb (c) Related tolerances. See § 556.113 of body weight by intramuscular injec- this chapter. tion for 3 days. Additional treatments (d) Special considerations. Federal law may be given on days 4 and 5 for ani- restricts this drug to use by or on the mals which do not show satisfactory order of a licensed veterinarian. Fed- response. eral law prohibits extra-label use of (ii) Indications for use. For treatment this drug in cattle, swine, chickens, of caprine respiratory disease (goat and turkeys for disease prevention pur- pneumonia) associated with poses; at unapproved doses, fre- Mannheimia haemolytica and Pasteurella quencies, durations, or routes of ad- multocida. ministration; and in unapproved major (5) Chickens—(i) Amount. 0.08 to 0.20 food-producing species/production mg as a single subcutaneous injection classes. in the neck.

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(ii) Indications for use. For control of basis of body weight. As a sedative-re- early mortality associated with Esch- laxant: Administer at a level of one- erichia coli organisms susceptible to fourth to one-half of the anesthetic ceftiofur in day-old chicks. dosage level. (6) Turkeys—(i) Amount. 0.17 to 0.5 mg (2) Indications for use. For general an- as a single subcutaneous injection in esthesia and as a sedative-relaxant in the neck. cattle and horses. (ii) For control of Indications for use. (3) Limitations. Federal law restricts early mortality associated with E. coli this drug to use by or on the order of a organisms susceptible to ceftiofur in licensed veterinarian. day-old poults. (7) Horses—(i) Amount. 2.2 to 4.4 mg/kg [79 FR 16185, Mar. 25, 2014] (1.0 to 2.0 mg/lb) body weight by intramuscular injection. Treatment § 522.390 Chloramphenicol. should be repeated every 24 hours, con- (a) Specifications. Each milliliter of tinued for 48 hours after clinical signs solution contains 100 milligrams of have disappeared, and should not ex- chloramphenicol. ceed 10 days. A maximum of 10 mL (b) See Nos. 054771 and 069043 should be administered per injection Sponsor. site. in § 510.600(c) of this chapter. (ii) Indications for use. For treatment (c) Conditions of use. Dogs—(1) of respiratory infections in horses asso- Amount. 5 to 15 milligrams per pound of ciated with Streptococcus zooepidemicus. body weight, intramuscularly or intra- (iii) Limitations. Do not use in horses venously, every 6 hours. In severe in- intended for human consumption. fections, use 4 to 6 hour treatment in- (8) Dogs—(i) Amount. 1.0 mg/lb (2.2 mg/ tervals the first day. If no response is kg) body weight by subcutaneous injec- obtained in 3 to 5 days, discontinue use tion. Treatment should be repeated at and reevaluate diagnosis. 24-hour intervals for 5 to 14 days. (2) Indications for use. Treatment of (ii) Indications for use. For treatment infections of the respiratory tract, the of canine urinary tract infections asso- urinary tract, and enteritis and tonsil- ciated with E. coli and Proteus mirabilis. litis caused by organisms susceptible [53 FR 5369, Feb. 24, 1988, as amended at 55 to chloramphenicol. FR 13768, Apr. 12, 1990; 56 FR 12119, Mar. 22, (3) Limitations. Federal law restricts 1991; 57 FR 41862, Sept. 14, 1992; 59 FR 41666, this drug to use by or on the order of a Aug. 15, 1994; 59 FR 54518, Nov. 1, 1994; 60 FR licensed veterinarian. Federal law pro- 51719, Oct. 3, 1995; 61 FR 35130, July 5, 1996; 61 FR 66583, Dec. 18, 1996; 66 FR 21283, Apr. 30, hibits the extralabel use of this drug in 2001; 66 FR 32540, June 15, 2001; 69 FR 47362, food-producing animals. Aug. 5, 2004. Redesignated and amended at 71 FR 39544, July 13, 2006; 74 FR 34236, July 15, [57 FR 37331, Aug. 18, 1992, as amended at 65 2009; 77 FR 29218, May 17, 2012; 79 FR 16185, FR 45877, July 26, 2000; 78 FR 17597, Mar. 22, Mar. 25, 2014; 79 FR 21127, Apr. 15, 2014; 82 FR 2013; 79 FR 16185, Mar. 25, 2014; 81 FR 17608, 12169, Mar. 1, 2017] Mar. 30, 2016]

§ 522.380 Chloral hydrate, pento- § 522.454 Clodronate. barbital, and magnesium sulfate. (a) Specifications. Each milliliter of (a) Specifications. Each milliliter of solution contains 60 milligrams (mg) solution contains 42.5 milligrams (mg) clodronate disodium. of chloral hydrate, 8.86 mg of pento- (b) Sponsor. See No. 043264 in barbital, and 21.2 mg of magnesium sul- § 510.600(c) of this chapter. fate. (c) Conditions of use in horses—(1) (b) Sponsor. See No. 054771 in Amount. Administer 1.8 mg per kilo- § 510.600(c) of this chapter. gram of body weight by intramuscular (c) Conditions of use—(1) Amount. For injection up to a maximum dose of 900 general anesthesia: Administer 20 to 50 milliliters per 100 pounds of body mg per horse. weight by intravenous injection until (2) Indications for use. For the control the desired effect is produced. Cattle of clinical signs associated with navic- usually require a lower dosage on the ular syndrome.

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(3) Limitations. Do not use in horses intramuscular injection, followed 30 to intended for human consumption. Fed- 72 hours later by 86 μg gonadorelin by eral law restricts this drug to use by or intramuscular injection. on the order of a licensed veterinarian. (2) Limitations. Gonadorelin acetate [79 FR 37620, July 2, 2014] for use in paragraph (c)(1)(iv) of this section as provided by No. 000061 in § 522.460 Cloprostenol. § 510.600(c) of this chapter. (a) Specifications. Each milliliter of [79 FR 16185, Mar. 25, 2014, as amended at 85 solution contains cloprostenol sodium FR 4208, Jan. 24, 2020] equivalent to: (1) 125 micrograms (μg) of § 522.468 Colistimethate sodium pow- cloprostenol; or der for injection. (2) 250 μg of cloprostenol. (a) Specifications. Each vial contains (b) Sponsors. See sponsors in colistimethate sodium equivalent to 10 § 510.600(c) of this chapter. grams colistin activity and mannitol (1) No. 000061 for use of product de- to be reconstituted with 62.5 milliliters scribed in paragraph (a)(1) of this sec- sterile saline or sterile water for injection as in paragraphs (c)(1)(i) and (c)(2) tion. The resulting solution contains of this section. colistimethate sodium equivalent to (2) Nos. 000061 and 068504 for use of 133 milligrams per milliliter colistin product described in paragraph (a)(2) as activity. in paragraphs (c)(1)(ii), (c)(1)(iii), and (b) Sponsor. See 054771 in § 510.600(c) of (c)(2) of this section. this chapter. (3) No. 000061 for use of product de- (c) Related tolerances. See § 556.167 of scribed in paragraph (a)(2) as in para- this chapter. graphs (c)(1)(iv) and (c)(2) of this sec- (d) Conditions of use. (1) 1- to 3-day- tion. old chickens. (c) Conditions of use in cattle—(1) (i) Dosage. 0.2 milligram colistin ac- Amount and indications for use—(i) Ad- tivity per chicken. μ minister 375 g by intramuscular injec- (ii) Indications for use. Control of tion to induce abortion in pregnant early mortality associated with Esch- feedlot heifers from 1 week after mat- 1 erichia coli organisms susceptible to ing until 4 ⁄2 months of gestation. colistin. (ii) Administer 500 μg by (iii) Limitations. For subcutaneous in- intramuscular injection for abortion of jection in the neck of 1- to 3-day-old unwanted pregnancies from chickens. Not for use in laying hens mismatings from 1 week after mating producing eggs for human consump- until 5 months after conception; for tion. Do not use in turkeys. Federal unobserved (non-detected) estrus; for law restricts this drug to use by or on treatment of mummified fetus, luteal the order of a licensed veterinarian. cysts, and pyometra or chronic endo- (2) [Reserved] metritis in beef cows, lactating dairy cows, and replacement beef and dairy [63 FR 13123, Mar. 18, 1998, as amended at 79 heifers. FR 16185, Mar. 25, 2014; 84 FR 32992, July 11, (iii) Administer 500 μg by 2019] intramuscular injection as a single injection regimen or double injection § 522.480 Corticotropin. regimen with a second injection 11 days (a) Specifications. Each milliliter of after the first, for estrus synchroni- aqueous solution contains 40 or 80 zation in beef cows, lactating dairy U.S.P. (I.U.) units of repository cows, and replacement beef and dairy corticotropin. heifers. (b) Sponsor. See sponsors in (iv) For use with gonadorelin acetate § 510.600(c) of this chapter. to synchronize estrous cycles to allow (1) No. 061133 for use as in paragraphs for fixed time artificial insemination (c)(1) and (2) of this section. (FTAI) in lactating dairy cows: Admin- (2) No. 026637 for use as in paragraph ister to each cow 86 μg gonadorelin by (c)(2) and (3) of this section. intramuscular injection, followed 6 to 8 (c) Conditions of use—(1) Dogs—(i) days later by 500 μg cloprostenol by Amount. Administer one unit per pound

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of body weight by intramuscular injec- eral law restricts this drug to use by or tion. on the order of a licensed veterinarian. (ii) Indications for use. As a diagnostic [46 FR 20159, Apr. 3, 1981, as amended at 52 aid to test for adrenal dysfunction. FR 7832, Mar. 13, 1987; 62 FR 28630, May 27, (iii) Limitations. Federal law restricts 1997] this drug to use by or on the order of a licensed veterinarian. § 522.522 Danofloxacin. (2) Dogs and cats—(i) Amount. Admin- (a) Specifications. Each milliliter of ister one unit per pound of body weight solution contains 180 milligrams (mg) by intramuscular or subcutaneous in- danofloxacin as the mesylate salt. jection, to be repeated as indicated. (b) Sponsor. See No. 054771 in (ii) Indications for use. For stimula- § 510.600(c) of this chapter. tion of the adrenal cortex where there (c) Related tolerances. See § 556.169 of is a general deficiency of corticotropin this chapter. (ACTH). (d) Conditions of use in cattle—(1) (iii) Limitations. Federal law restricts Amount and indications for use. Admin- this drug to use by or on the order of a ister by subcutaneous injection either: licensed veterinarian. (i) 6 mg per kilogram (/kg) of body (3) Cattle—(i) Amount. Administer 200 weight, repeated in 48 hours, for the to 600 units by intramuscular or sub- treatment of bovine respiratory disease cutaneous injection as an initial dose, (BRD) associated with Mannheimia followed by a dose daily or every other haemolytica and Pasteurella multocida; day of 200 to 300 units. or (ii) Indications for use. As a thera- (ii) 8 mg/kg of body weight as a single peutic agent for primary bovine keto- dose for the treatment of BRD associ- sis; and for stimulation of the adrenal ated with M. haemolytica and P. cortex where there is a general defi- multocida and for the control of BRD in ciency of ACTH. beef cattle at high risk of developing (iii) Limitations. Federal law restricts BRD associated with M. haemolytica this drug to use by or on the order of a and P. multocida. licensed veterinarian. (2) Limitations. Animals intended for human consumption should not be [79 FR 16185, Mar. 25, 2014, as amended at 84 slaughtered within 4 days from the last FR 8973, Mar. 13, 2019] treatment. Do not use in cattle intended for dairy production. A with- § 522.518 Cupric glycinate injection. drawal period has not been established (a) Specifications. Each milliliter for this product in pre-ruminating (mL) of sterile aqueous suspension con- calves. Do not use in calves to be proc- tains 200 milligrams of cupric glycinate essed for veal. Federal law restricts (equivalent to 60 milligrams of copper). this drug to use by or on the order of a (b) Sponsor. See No. 049185 in licensed veterinarian. Federal law pro- § 510.600(c) of this chapter. hibits the extra-label use of this drug (c) Conditions of use—(1) Amount. 200 in food-producing animals. milligrams (1 mL) for calves 300 pounds [67 FR 78972, Dec. 27, 2002, as amended at 77 and under; 400 milligrams (2 mL) for FR 4227, Jan. 27, 2012; 79 FR 16185, Mar. 25, calves over 300 pounds and adult cattle. 2014; 79 FR 53136, Sept. 8, 2014] (2) Indications for use. For beef calves and beef cattle for the prevention of § 522.533 Deslorelin. copper deficiency, or when labeled for (a) Specifications—(1) Each implant veterinary prescription use, for the contains 2.1 milligrams (mg) deslorelin prevention and/or treatment of copper acetate. deficiency alone or in association with (2) Each milliliter (mL) of suspension molybdenum toxicity. contains 1.8 mg deslorelin acetate. (3) Limitations. For subcutaneous use (b) Sponsors. See sponsor numbers in only; repeat dose in 3 months in young § 510.600(c) of this chapter as follows: calves, in 6 months in cattle; dis- (1) No. 051311 for use of product de- continue use 30 days before treated ani- scribed in paragraph (a)(1) as in para- mals are slaughtered for food use; Fed- graph (c)(1) of this section.

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(2) No. 051330 for use of product de- with primary hypoadrenocorticism scribed in paragraph (a)(2) as in para- (Addison’s Disease). graph (c)(2) of this section. (ii) For use as replacement therapy (c) Conditions of use—(1) Horses and for the mineralocorticoid deficit in ponies—(i) Amount. One implant per dogs with primary adrenocortical in- mare subcutaneously in the neck. sufficiency. (ii) Indications for use. For inducing (3) Limitations. Federal law restricts ovulation within 48 hours in estrous this drug to use by or on the order of a mares with an ovarian follicle greater licensed veterinarian. than 30 mL in diameter. (iii) Limitations. Do not use in horses [81 FR 22524, Apr. 18, 2016] or ponies intended for human consump- § 522.536 Detomidine. tion. Federal law restricts this drug to use by or on the order of a licensed vet- (a) Specification. Each milliliter of so- erinarian. lution contains 10 milligrams of (2) Horses—(i) Amount. Administer 1.8 detomidine hydrochloride. mg (1 mL) by intramuscular injection (b) Sponsor. See No. 052483 in in the neck. § 510.600(c) of this chapter. (ii) Indications for use. For inducing (c) Conditions of use in horses—(1) ovulation within 48 hours in cyclic es- Amount. For sedation, analgesia, or se- trous mares with an ovarian follicle be- dation and analgesia: 20 or 40 tween 30 and 40 mL in diameter. micrograms per kilogram (0.2 or 0.4 (iii) Limitations. Do not use in horses milliliter per 100 kilogram or 220 intended for human consumption. Fed- pounds) by body weight, depending on eral law restricts this drug to use by or depth and duration required. For seda- on the order of a licensed veterinarian. tion, administer by intraveneous (IV) or intramuscular (IM) injection; for an- [75 FR 81456, Dec. 28, 2010, as amended at 79 algesia, administer by IV injection; for FR 18158, Apr. 1, 2014] both sedation and analgesia, admin- § 522.535 Desoxycorticosterone. ister by IV injection. (2) Indication for use. As a sedative (a) Specifications. Each milliliter of and analgesic to facilitate minor sur- suspension contains 25 milligrams (mg) gical and diagnostic procedures in ma- of desoxycorticosterone pivalate. ture horses and yearlings. (b) Sponsors. See sponsor numbers in (3) Limitations. Do not use in horses § 510.600(c) of this chapter. intended for human consumption. Fed- (1) No. 043264 for use as in paragraphs eral law restricts this drug to use by or (c)(1)(i), (c)(2)(i), and (c)(3) of this sec- on the order of a licensed veterinarian. tion. (2) No. 058198 for use as in paragraphs [79 FR 16186, Mar. 25, 2014] (c)(1)(ii), (c)(2)(ii), and (c)(3) of this section. § 522.540 Dexamethasone solution. (c) Conditions of use—(1) Amount. (i) (a)(1) Specifications. Each milliliter of Administer an initial dose of 2.2 mg/ solution contains 2 milligrams (mg) kilogram (1 mg/lb) of body weight by dexamethasone. subcutaneous injection. Subsequent (2) Sponsors. See sponsors in dosages should be individualized ac- § 510.600(c) of this chapter: cording to label instructions based on (i) Nos. 000061, 016592, and 061133 for patient response to therapy. use as in paragraph (a)(3) of this sec- (ii) Dosage requirements are variable tion. and must be individualized on the basis (ii) Sponsors. See Nos. 054925 and of the response of the patient to ther- 058005 for use as in paragraphs apy. Initial dose of 1 milligram per (a)(3)(i)(C), (a)(3)(i)(D), (a)(3)(ii)(A), and pound (0.45 kilogram) of body weight (a)(3)(iii) of this section. every 25 days, intramuscularly. Usual (3) Conditions of use—(i) Amount. The dose is 0.75 to 1.0 milligram per pound drug is administered intravenously or of body weight every 21 to 30 days. intramuscularly and dosage may be re- (2) Indications for use—(i) For use as peated if necessary, as follows: replacement therapy for (A) Dogs. 0.25 to 1 mg. mineralocorticoid deficiency in dogs (B) Cats. 0.125 to 0.5 mg.

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(C) Horses. 2.5 to 5 mg. (2) Sponsors. See the following num- (D) Cattle. 5 to 20 mg, depending on bers in § 510.600(c) of this chapter: the severity of the condition. (i) Nos. 016592 and 051031 for intra- (ii) Indications for use. The drug is in- venous or intramuscular use of 2.0 mil- dicated: ligrams dexamethasone injection. (A) For the treatment of primary bo- (ii) No. 054771 for intravenous use of vine ketosis and as an anti-inflam- 2.0 milligrams dexamethasone injec- matory agent in cattle and horses; tion. (B) As an anti-inflammatory agent in (3) Conditions of use—(i) Amount. Ad- dogs and cats. minister by intravenous or (iii) Limitations. Do not use in horses intramuscular injection as follows: intended for human consumption. Fed- (A) Dogs: 0.25 to 1 mg. eral law restricts this drug to use by or (B) Cats: 0.125 to 0.5 mg. on the order of a licensed veterinarian. (C) Horses: 2.5 to 5 mg. (b)(1) Specifications. Each milliliter of (ii) Indications for use. For use in solution contains 2.0 mg of dexametha- dogs, cats, and horses as an anti-in- sone or 4.0 mg of dexamethasone so- flammatory agent. dium phosphate (equivalent to 3.0 mg (iii) Limitations. Do not use in horses dexamethasone). intended for human consumption. Fed- (2) Sponsor. See No. 061133 in eral law restricts this drug to use by or § 510.600(c) of this chapter. 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). (ii) Indications for use. For use in dogs (2) Sponsor. See No. 069043 in for the treatment of inflammatory con- § 510.600(c) of this chapter. ditions, as supportive therapy in ca- (3) Conditions of use—(i) Amount. Ad- nine posterior paresis, as supportive minister by intravenous injection as therapy before or after surgery to en- follows: hance recovery of poor surgical risks, (A) Dogs: 0.25 to 1 mg; may be re- and as supportive therapy in nonspe- peated for 3 to 5 days. cific dermatosis. (B) Horses: 2.5 to 5 mg. (iii) Limitations. Federal law restricts (ii) Indications for use. For use in dogs this drug to use by or on the order of a and horses for glucocorticoid and anti- licensed veterinarian. inflammatory effect. (c)(1) Specifications. Each milliliter of (iii) Limitations. Do not use in horses solution contains 2.0 mg of dexametha- intended for human consumption. Fed- sone or 4.0 mg of dexamethasone so- eral law restricts this drug to use by or dium phosphate (equivalent to 3.0 mg on the order of a licensed veterinarian. of dexamethasone). (2) Sponsor. See No. 061133 in [41 FR 28265, July 9, 1976] § 510.600(c) of this chapter. EDITORIAL NOTE: For FEDERAL REGISTER ci- (3) Conditions of use—(i) Amount. Ad- tations affecting § 522.540, see the List of CFR minister 2.5 to 5.0 mg by intravenous Sections Affected, which appears in the injection. Finding Aids section of the printed volume (ii) Indications for use. For use in and at www.govinfo.gov. horses as a rapid adrenal glucocorticoid and/or anti-inflam- § 522.542 Dexamethasone suspension. matory agent. (a) Specifications. Each milliliter of (iii) Limitations. Do not use in horses suspension contains 1 milligram (mg) intended for human consumption. Fed- of dexamethasone-21-isonicotinate. eral law restricts this drug to use by or (b) Sponsor. No. 000010 in § 510.600(c) of on the order of a licensed veterinarian. this chapter. (d)(1) Specifications. Each milliliter of (c) Conditions of use—(1) Amount. Ad- solution contains 2.0 mg of dexametha- minister by intramuscular injection as sone or 4.0 mg of dexamethasone so- follows: Dogs: 0.25 to 1 mg; cats: 0.125 to dium phosphate (equivalent to 3.0 mg 0.5 mg; horses: 5 to 20 mg. Dosage may of dexamethasone). be repeated.

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(2) Indications for use. For the treat- (iii) Limitations. Federal law restricts ment of various inflammatory condi- this drug to use by or on the order of a tions associated with the musculo- licensed veterinarian. skeletal system in dogs, cats, and [72 FR 263, Jan. 4, 2007, as amended at 72 FR horses. 19797, Apr. 20, 2007; 72 FR 51365, Sept. 7, 2007; (3) Limitations. Do not use in horses 75 FR 60308, Sept. 30, 2010; 78 FR 25183, Apr. intended for human consumption. Fed- 30, 2013; 78 FR 33699, June 5, 2013; 80 FR 13229, eral law restricts this drug to use by or Mar. 13, 2015] on the order of a licensed veterinarian. § 522.563 Diatrizoate. [79 FR 16186, Mar. 25, 2014] (a) Specifications. Each milliliter of solution contains 34.3 percent dia- § 522.558 Dexmedetomidine. trizoate meglumine and 35 percent dia- (a) Specifications. Each milliliter of trizoate sodium, or 66 percent dia- solution contains: trizoate meglumine and 10 percent dia- (1) 0.1 milligrams (mg) trizoate sodium. dexmedetomidine hydrochloride; or (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (2) 0.5 mg dexmedetomidine hydro- (c) Conditions of use in dogs and cats— chloride. (1) Amount. For excretion urography, (b) Sponsors. See sponsors in in administer 0.5 to 1.0 milliliter (mL) per § 510.600(c) of this chapter for use as in pound of body weight to a maximum of paragraph (c) of this section: 30 mL intravenously. For cystography, (1) No. 026637 for use of product de- remove urine, administer 5 to 25 mL di- scribed in paragraph (a)(2) of this sec- rectly into the bladder via catheter. tion; For urethrography, administer 1.0 to 5 (2) No. 052483 for use of products de- mL via catheter into the urethra to scribed in paragraph (a) of this section. provide desired contrasts delineation. (c) Conditions of use—(1) Dogs—(i) In- For angiocardiography (including dications for use and amount. (A) For aortography) rapidly inject 5 to 10 mL use as a sedative and analgesic to fa- directly into the heart via catheter or cilitate clinical examinations, clinical intraventricular puncture. For cerebral procedures, minor surgical procedures, angiography, rapid injection of 3 to 10 and minor dental procedures, admin- mL via carotid artery. For peripheral ister 375 micrograms (μg) per square arteriography and/or venography and meter (/m2) of body surface area by in- selective coronary arteriography, rapidly inject 3 to 10 mL intravascularly travenous injection or 500 μg/m2 of body into the vascular bed to be delineated. surface area by intramuscular injec- For lymphography, slowly inject 1.0 to tion. 10 mL directly into the lymph vessel to (B) For use as a preanesthetic to gen- be delineated. For arthrography, slow- μ 2 eral anesthesia, administer 125 g/m of ly inject 1.0 to 5 mL directly into the body surface area or 375 μg/m2 of body joint to be delineated. For discography, surface area by intramuscular injec- slowly inject 0.5 to 1.0 mL directly into tion. the disc to be delineated. For sialog- (ii) Limitations. Federal law restricts raphy, slowly inject 0.5 to 1.0 mL into this drug to use by or on the order of a the duct to be delineated. For delinea- licensed veterinarian. tion of fistulous tracts, slowly inject (2) Cats—(i) Amount. 40 μg/killogram quantity necessary to fill the tract. by intramuscular injection. For delineation of peritoneal hernias, (ii) Indications for use. For use as a inject 0.5 to 1.0 mL per pound of body sedative and analgesic to facilitate weight directly into the peritoneal cav- clinical examinations, clinical proce- ity. dures, minor surgical procedures, and (2) Indications for use. For visualiza- minor dental procedures; and as a tion in excretion urography, including preanesthetic to general anesthesia. renal angiography, uretography, cystography, and urethrography; aortography; angiocardiography, peripheral arteriography, and

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venography; selective coronary arteri- (3) No. 061133 for use of the 5 mg/mL ography; cerebral angiography; product as in paragraphs (d)(2), (3), and lymphography; arthrography; discog- (4) of this section. raphy; and sialography; and as an aid (c) Special considerations. Federal law in delineating peritoneal hernias and restricts this drug to use by or on the fistulous tracts. order of a licensed veterinarian. (3) Limitations. Federal law restricts (d) Conditions of use—(1) Cattle. Ad- this drug to use by or on the order of a minister product described in para- licensed veterinarian. graph (b)(1) of this section as follows: [79 FR 16186, Mar. 25, 2014] (i) Amount. 25 mg as a single intramuscular or subcutaneous injec- § 522.650 Dihydrostreptomycin sulfate tion. injection. (ii) Indications for use. As a luteolytic (a) Specifications. Each milliliter con- agent; effective only in those cattle tains dihydrostreptomycin sulfate having a corpus luteum, i.e., those equivalent to 500 milligrams of dihy- which ovulated at least 5 days prior to drostreptomycin. treatment. (b) Sponsor. See No. 054771 in (A) For estrus synchronization in § 510.600(c) of this chapter. beef cows, beef heifers and replacement (c) Related tolerance. See § 556.200 of dairy heifers. this chapter. (B) For unobserved (silent) estrus in (d) Conditions of use—(1) Amount. Ad- lactating dairy cows with a corpus minister 5 milligrams per pound of luteum. body weight by deep intramuscular in- (C) For treatment of pyometra jection every 12 hours, for 3 to 5 days or (chronic endometritis) in cattle. until the urine is free of leptospira for (D) For abortion in beef cows, beef at least 72 hours as measured by heifers and replacement dairy heifers. darkfield microscopic examination. (E) For use with gonadorelin injec- (2) Indications for use. Treatment of tion as in § 522.1077 of this chapter to leptospirosis in dogs and horses due to synchronize estrous cycles to allow Leptospira canicola, L. fixed-time artificial insemination icterohemorrhagiae, and L. pomona; in (FTAI) in lactating dairy cows. cattle due to L. pomona; and in swine (F) For use with progesterone due to L. pomona; and L. grippotyphosa. intravaginal inserts as in § 529.1940 of (3) Limitations. Discontinue use 30 this chapter for synchronization of days before slaughter for food. Not for estrus in lactating dairy cows. use in animals producing milk because (G) For use with progesterone use of the drug will contaminate the intravaginal inserts as in § 529.1940 of milk. Federal law restricts this drug to this chapter for synchronization of use by or on the order of a licensed vet- estrus in suckled beef cows and re- erinarian. placement beef and dairy heifers, ad- [57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept. vancement of first postpartum estrus 15, 1992; 79 FR 16187, Mar. 25, 2014; 85 FR 18119, in suckled beef cows, and advancement Apr. 1, 2020] of first pubertal estrus in beef heifers. (2) Horses—(i) Amount. 1 mg per 100 § 522.690 Dinoprost. pounds of body weight as a single (a) Specifications. Each milliliter intramuscular injection. (mL) of solution contains dinoprost (ii) Indications for use. For its tromethamine equivalent to 5 milli- luteolytic effect to control timing of grams (mg) or 12.5 mg dinoprost. estrus in estrus cycling mares and in (b) Sponsors. See sponsors in clinically anestrous mares that have a § 510.600(c) of this chapter. corpus luteum. (1) No. 054771 for use of the 12.5 mg/ (iii) Limitations. Do not use in horses mL product as in paragraph (d)(1) of intended for human consumption. this section. (3) Swine—(i) Amount. 10 mg as a sin- (2) No. 054771 for use of the 5 mg/mL gle intramuscular injection. product as in paragraphs (d)(1), (2), and (ii) Indications for use. For parturi- (3) of this section. tion induction in swine when injected

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within 3 days of normal predicted (3) Limitations. For use in wild or ex- farrowing. otic animals only. Do not use in domes- (4) Cattle. Administer product de- tic food-producing animals. Do not use scribed in paragraph (b)(2) of this sec- 30 days before, or during, the hunting tion as follows: season in free-ranging wild animals (i) Beef cattle and nonlactating dairy that might be used for food. Federal heifers—(A) Amount. 25 mg as an law restricts this drug to use by or on intramuscular injection either once or the order of a licensed veterinarian. twice at a 10- to 12-day interval. Distribution is restricted to veterinar- (B) Indications. For its luteolytic ef- ians engaged in zoo and exotic animal fect to control timing of estrus and practice, wildlife management pro- ovulation in estrous cycling cattle that grams, and researchers. have a corpus luteum. [79 FR 16187, Mar. 25, 2014] (ii) Beef cattle and nonlactating dairy heifers—(A) Amount. 25 mg as a single § 522.728 Dipyrone. intramuscular injection. (B) Indications. For treatment of (a) Specifications. Each milliliter of pyometra (chronic endometritis). solution contains 500 milligrams (mg) (iii) Nonlactating cattle—(A) Amount. dipyrone. 25 mg as a single intramuscular injec- (b) Sponsor. See No. 086078 in tion during the first 100 days of gesta- § 510.600(c) of this chapter. tion. (c) Conditions of use in horses—(1) (B) Indications. For its abortifacient Amount. Administer 30 mg per kilo- effect in nonlactating cattle. gram of body weight (13.6 mg per (iv) Lactating dairy cattle—(A) pound) by intravenous injection, once Amount. 25 mg as a single or twice daily at a 12-hour interval for intramuscular injection. up to 3 days. (B) Indications. For treatment of (2) Indications for use. For control of unobserved (silent) estrus in lactating pyrexia in horses. dairy cattle that have a corpus luteum. (3) Limitations. Do not use in horses (v) Dinoprost injection as provided by intended for human consumption. Do No. 054771 in § 510.600(c) of this chapter not use in any food-producing animals, may also be used concurrently with including lactating dairy animals. Fed- gonadorelin hydrochloride injection as eral law restricts this drug to use by or in § 522.1077 and with progesterone on the order of a licensed veterinarian. intravaginal inserts as in § 529.1940 of [85 FR 18119, Apr. 1, 2020] this chapter. § 522.770 Doramectin. [67 FR 41824, June 20, 2002, as amended at 79 FR 16187, Mar. 25, 2014; 79 FR 44278, July 31, (a) Specifications. Each milliliter of 2014; 79 FR 64116, Oct. 28, 2014; 80 FR 61296, solution contains 10 milligrams of Oct. 13, 2015; 80 FR 76386, Dec. 9, 2015; 81 FR doramectin. 36789, June 8, 2016; 84 FR 8973, Mar. 13, 2019] (b) Sponsor. See No. 054771 in § 510.600 (c) of this chapter. § 522.723 Diprenorphine. (c) Related tolerances. See § 556.222 of (a) Specifications. Each milliliter of this chapter. solution contains 2 milligrams of (d) Conditions of use—(1) Cattle—(i) diprenorphine hydrochloride. Amount. 200 micrograms per kilogram (b) Sponsors. See No. 053923 in (10 milligrams per 110 pounds). § 510.600(c) of this chapter. (ii) Indications for use. For treatment (c) Conditions of use—(1) Amount. It is and control of gastrointestinal administered intramuscularly or intra- roundworms, lungworms, eyeworms, venously at a suitable dosage level de- grubs, sucking lice, and mange mites. pending upon the species. To control infections and to protect (2) Indications for use. The drug is from reinfection with Cooperia used for reversing the effects of oncophora and Haemonchus placei for 14 etorphine hydrochloride injection, vet- days, Ostertagia ostertagi for 21 days, erinary, the use of which is provided and C. punctata, Oesophagostomum for in § 522.883, in wild and exotic ani- radiatum, and Dictyocaulus viviparus for mals. 28 days after treatment.

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(iii) Limitations. Administer as a sin- (3) Limitations. Federal law restricts gle subcutaneous or intramuscular in- this drug to use by or on the order of a jection. Do not slaughter cattle within licensed veterinarian. 35 days of treatment. Not for use in fe- [72 FR 261, Jan. 4, 2007, as amended at 75 FR male dairy cattle 20 months of age or 10167, Mar. 5, 2010; 77 FR 60302, Oct. 3, 2012] older. Do not use in calves to be processed for veal. § 522.784 Doxylamine. (2) Swine—(i) Amount. 300 micrograms (a) Specifications. Each milliliter con- per kilogram (10 milligrams per 75 tains 11.36 milligrams (mg) of pounds). doxylamine succinate. (ii) For treatment Indications for use. (b) Sponsor. See No. 000061 in and control of gastrointestinal § 510.600(c) of this chapter. roundworms, lungworms, kidney (c) Conditions of use—(1) Amount—(i) worms, sucking lice, and mange mites. Horses: Administer 25 mg per hundred (iii) Limitations. Administer as a sin- pounds of body weight by gle intramuscular injection. Do not intramuscular, subcutaneous, or slow slaughter swine within 24 days of treat- intravenous injection. ment. Consult your veterinarian for as- (ii) Dogs and cats: Administer 0.5 to 1 sistance in the diagnosis, treatment, mg per pound of body weight by and control of parasitism. intramuscular or subcutaneous injec- [61 FR 53321, Oct. 11, 1996, as amended at 62 tion. Doses may be repeated at 8 to 12 FR 44410, Aug. 21, 1997; 62 FR 62242, Nov. 21, hours, if necessary, to produce desired 1997; 63 FR 68183, Dec. 10, 1998; 64 FR 13509, effect. Mar. 19, 1999; 79 FR 16187, Mar. 25, 2014; 84 FR (2) Indications for use. For use in con- 32992, July 11, 2019] ditions in which antihistaminic therapy may be expected to alleviate some § 522.775 Doxapram. signs of disease in horses, dogs, and (a) Specifications. Each milliliter of cats. solution contains 20 milligrams (mg) (3) Limitations. Do not use in horses doxapram hydrochloride. intended for human consumption. Fed- (b) Sponsor. See No. 000010 in eral law restricts this drug to use by or § 510.600(c) of this chapter. on the order of a licensed veterinarian. (c) Conditions of use—(1) Amount. For intravenous use in dogs and cats at a [79 FR 16187, Mar. 25, 2014] 1 dose of 2 ⁄2 to 5 mg per pound (/lb) body § 522.800 Droperidol and fentanyl. weight in barbiturate anesthesia, 0.5 mg/lb in inhalation anesthesia; for in- (a) Specifications. Each milliliter of travenous use in horses at 0.25 mg/lb solution contains 20 milligrams (mg) of body weight in barbiturate anesthesia, droperidol and 0.4 mg of fentanyl cit- 0.2 mg/lb in inhalation anesthesia, 0.25 rate. mg/lb with chloral hydrate with or (b) Sponsor. See No. 000061 in without magnesium sulfate; for sub- § 510.600(c) of this chapter. cutaneous, sublingual, or umbilical (c) Conditions of use—(1) Amount. vein administration in neonate puppies (i) For analgesia and tranquilization, at a dose rate of 1 to 5 mg; for subcuta- administer as follows: neous or sublingual use in neonate kit- (A) 1 milliliter (mL) per 15 to 20 tens at 1 to 2 mg. Dosage may be re- pounds (lbs) of body weight by peated in 15 to 20 minutes if necessary. intramuscular injection in conjunction (2) Indications for use. Administer to with atropine sulfate administered at dogs, cats, and horses to stimulate res- the rate of 0.02 mg per pound of body piration during and after general anes- weight; or thesia; or to speed awakening and re- (B) 1 mL per 25 to 60 lbs of body turn of reflexes after anesthesia. Ad- weight by intravenous injection in con- minister to neonate dogs and cats to junction with atropine sulfate adminis- initiate respiration following dystocia tered at the rate of 0.02 mg per pound or caesarean section; or to stimulate of body weight. respiration following dystocia or cae- (ii) For general anesthesia, admin- sarean section. ister as follows:

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(A) Administer 1 mL per 40 lbs of (2) Nos. 000859, 055529, and 061133 for body weight by intramuscular injec- use of product described in paragraph tion in conjunction with atropine sul- (a)(2) as in paragraphs (e)(2) and (3) of fate administered at the rate of 0.02 mg this section. per pound of body weight and followed (c) Related tolerance. See § 556.226 of in 10 minutes by an intravenous admin- this chapter. istration of sodium pentobarbital at (d) Special considerations. Federal law the rate of 3 mg per pound of body restricts this drug to use by or on the weight; or order of a licensed veterinarian. Fed- (B) Administer 1 mL per 25 to 60 lbs eral law prohibits the extra-label use of of body weight by intravenous injec- this drug in food-producing animals. tion in conjunction with atropine sul- (e) Conditions of use—(1) Dogs. Use the fate administered at the rate of 0.02 mg product described in paragraph (a)(1) of per pound of body weight and followed this section as follows: within 15 seconds by an intravenous ad- (i) Amount. 2.5 mg per kilogram (/kg) ministration of sodium pentobarbital of body weight (1.13 mg per pound) as a at the rate of 3 mg per pound of body single, intramuscular, initial dose fol- weight. lowed by use of tablets twice daily for (2) Indications for use. As an analgesic 2 to 3 days beyond cessation of clinical and tranquilizer and for general anes- signs to a maximum of 10 days. thesia. (ii) Indications for use. For the man- (3) Limitations. Federal law restricts agement of diseases associated with this drug to use by or on the order of a bacteria susceptible to enrofloxacin. licensed veterinarian. (2) Cattle. Use the product described [79 FR 16187, Mar. 25, 2014] in paragraph (a)(2) of this section as follows: § 522.810 Embutramide, chloroquine, (i) Amount—(A) Single-dose therapy: and lidocaine solution. For treatment of bovine respiratory (a) Specifications. Each milliliter disease (BRD), administer 7.5 to 12.5 (mL) of solution contains 135 milli- mg/kg of body weight (3.4 to 5.7 mL per grams (mg) embutramide; 45 mg 100 pounds (/100 lb)) once by subcuta- chloroquine phosphate, U.S.P.; and 1.9 neous injection. For control of BRD, mg lidocaine, U.S.P. administer 7.5 mg/kg of body weight (b) Sponsor. See No. 069043 in (3.4 mL/100 lb) once by subcutaneous in- § 510.600(c) of this chapter. jection. (c) Conditions of use in dogs—(1) (B) Multiple-day therapy: For treat- Amount. One mL per 5 pounds of body ment of BRD, administer 2.5 to 5.0 mg/ weight. kg of body weight (1.1 to 2.3 mL/100 lb) (2) Indications for use. For euthanasia. by subcutaneous injection. Treatment (3) Limitations. Not for use in animals should be repeated at 24-hour intervals intended for food. Federal law restricts for 3 days. Additional treatments may this drug to use by or on the order of a be given on days 4 and 5 to animals licensed veterinarian. that have shown clinical improvement [70 FR 36337, June 23, 2005, as amended at 78 but not total recovery. FR 17597, Mar. 22, 2013; 81 FR 17608, Mar. 30, (ii) Indications for use—(A) Single-dose 2016] therapy: For the treatment of BRD associated with Mannheimia haemolytica, § 522.812 Enrofloxacin. Pasteurella multocida, Histophilus somni, (a) Specifications. Each milliliter and Mycoplasma bovis in beef and non- (mL) of solution contains: lactating dairy cattle; for the control (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) Nos. 000859, 026637, and 055529 for treatment of bovine respiratory disease use of product described in paragraph (BRD) associated with Mannheimia (a)(1) as in paragraph (e)(1); and haemolytica, Pasteurella multocida, and

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Histophilus somni in beef and non-lac- gram of body weight by subcutaneous tating dairy cattle. injection. (iii) Limitations. Animals intended for (2) Indications for use. For the treat- human consumption must not be ment and control of the following in- slaughtered within 28 days from the ternal and external parasites: Gastro- last treatment. This product is not ap- intestinal roundworms (adults and proved for female dairy cattle 20 fourth-stage larvae) Bunostomum months of age or older, including dry phlebotomum, Cooperia oncophora, C. dairy cows. Use in these cattle may punctata, C. surnabada, Trichostrongylus cause drug residues in milk and/or in axei, Ostertagia ostertagi (including in- calves born to these cows. A with- hibited stage); (adults) Haemonchus drawal period has not been established placei, Oesophagostomum radiatum, O. for this product in preruminating lyrata, T. colubriformis; lungworms calves. Do not use in calves to be proc- (adults) Dictyocaulus viviparus; cattle essed for veal. grubs Hypoderma bovis; mites Sarcoptes (3) Swine. Use the product described scabiei var. bovis. Prevents reinfection in paragraph (a)(2) of this section as with C. oncophora, C. punctata, and T. follows: axei for 100 days following treatment; (i) Amounts and indications for use. (A) H. placei, O. radiatum, O. lyrata, and O. Administer 7.5 mg/kg of body weight ostertagi for 120 days following treat- once, by intramuscular or subcuta- ment; and B. phlebotomum and D. neous injection behind the ear, for the viviparus for 150 days following treat- treatment and control of swine res- ment. piratory disease (SRD) associated with (3) Limitations. Federal law restricts Actinobacillus pleuropneumoniae, this drug to use by or on the order of a Pasteurella multocida, Haemophilus licensed veterinarian. Animals in- parasuis, Streptococcus suis, Bordetella tended for human consumption must bronchiseptica, and Mycoplasma not be slaughtered within 48 days of hyopneumoniae. the last treatment. This drug product (B) Administer 7.5 mg/kg of body is not approved for use in female dairy weight once, by intramuscular or sub- cattle 20 months of age or older, in- cutaneous injection behind the ear, for cluding dry dairy cows. Use in these the control of colibacillosis in groups cattle may cause drug residues in milk or pens of weaned pigs where and/or in calves born to these cows. A colibacillosis associated with Esch- withdrawal period has not been estab- erichia coli has been diagnosed. lished for pre-ruminating calves. Do (ii) Limitations. Animals intended for not use in calves to be processed for human consumption must not be veal. slaughtered within 5 days of receiving a single-injection dose. [76 FR 72618, Nov. 25, 2011, as amended at 79 FR 37620, July 2, 2014; 84 FR 39184, Aug. 9, [72 FR 10597, Mar. 9, 2007, as amended at 73 2019] FR 17890, Apr. 2, 2008; 73 FR 21819, Apr. 23, 2008; 76 FR 22611, Apr. 22, 2011; 77 FR 55415, § 522.820 Erythromycin. Sept. 10, 2012; 77 FR 76863, Dec. 31, 2012; 78 FR (a) Specifications—(1) Each milliliter 19987, Apr. 3, 2013; 79 FR 37620, July 2, 2014; 80 FR 13229, Mar. 13, 2015; 80 FR 18776, Apr. 8, (mL) of solution contains 100 milli- 2015; 80 FR 61296, Oct. 13, 2015; 84 FR 8973, grams (mg) erythromycin base. Mar. 13, 2019; 84 FR 53311, Oct. 7, 2019] (2) Each mL of solution contains 200 mg erythromycin base. § 522.814 Eprinomectin. (b) Sponsor. See No. 061133 in (a) Specifications. Each milliliter of § 510.600(c) of this chapter. solution contains 50 milligrams (mg) (c) Related tolerances. See § 556.230 of eprinomectin. this chapter. (b) Sponsor. See No. 000010 in (d) Conditions of use—(1) Dog. Admin- § 510.600(c) of this chapter. ister product described in paragraph (c) Related tolerances. See §§ 500.1410 (a)(1) of this section as follows: and 556.227 of this chapter. (i) Amount. 3 to 5 mg per pound (/lb) (d) Conditions of use in cattle on pas- body weight, intramuscularly, two to ture—(1) Amount. Administer 1 mg/kilo- three times daily, for up to 5 days.

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(ii) Indications for use. For the treat- not less than 0.5 mg oxytetracycline ment of bacterial pneumonia, upper powder. respiratory infections (tonsillitis, (b) Sponsor. See No. 058198 in bronchitis, tracheitis, pharyngitis, § 510.600(c) of this chapter. pleurisy), endometritis and metritis, (c) Related tolerances. See § 556.240 of and bacterial wound infections caused this chapter. by Staphylococcus spp., Streptococcus (d) Conditions of use. For implanta- spp., and Corynebacterium spp., sen- tion in steers and heifers as follows: sitive to erythromycin. (1) Amount. Insert one 25.7-mg im- (iii) Limitations. Federal law restricts plant every 200 days; insert one 43.9-mg this drug to use by or on the order of a implant every 400 days. licensed veterinarian. (2) Indications for use. For increased (2) Cats. Administer product de- rate of weight gain in suckling and scribed in paragraph (a)(1) of this sec- pastured growing steers; for improved tion as follows: feed efficiency and increased rate of (i) Amount. 3 to 5 mg/lb body weight, weight gain in confined steers and heif- intramuscularly, two to three times ers. No additional effectiveness may be daily, for up to 5 days. expected from reimplanting in less (ii) Indications for use. For the treat- than 200 days for the 25.7-mg implant ment of bacterial pneumonia, upper or 400 days for the 43.9-mg implant. respiratory infections (rhinitis, bron- (3) Limitations. For subcutaneous ear chitis), secondary infections associated implantation in steers and heifers only. with panleukopenia, and bacterial Safety and effectiveness have not been wound infections caused by Staphy- established in veal calves. A with- lococcus spp. and Streptococcus spp., sus- drawal period has not been established ceptible to erythromycin. for this product in preruminating (iii) Limitations. Federal law restricts calves. Do not use in calves to be proc- this drug to use by or on the order of a essed for veal. licensed veterinarian. [69 FR 67818, Nov. 22, 2004, as amended at 77 (3) Cattle. Administer products de- FR 31723, May 30, 2012; 81 FR 48702, July 26, scribed in paragraph (a) of this section 2016] as follows: § 522.842 Estradiol benzoate and tes- (i) Amount. 4 mg/lb body weight by tosterone propionate. deep intramuscular injection once daily for up to 5 days. (a) Sponsors. See sponsors in (ii) Indications for use. For the treat- § 510.600(c) of this chapter for use as in ment of bovine respiratory disease paragraph (c) of this section. (shipping fever complex and bacterial (1) No. 054771 for use as in paragraph pneumonia) associated with Pasteurella (c)(1)(i), (c)(2), and (c)(3) of this section. multocida susceptible to erythromycin. (2) No. 058198 for use as in paragraph (c) of this section. (iii) Limitations. Do not use in female (b) Related tolerances. See §§ 556.240 dairy cattle over 20 months of age. Do and 556.710 of this chapter. not slaughter treated animals within 6 (c) Conditions of use. For implanta- days of last treatment. A withdrawal tion in heifers as follows: period has not been established for this (1) Amount. (i) 20 milligrams (mg) es- product in pre-ruminating calves. Do tradiol benzoate and 200 mg testos- not use in calves to be processed for terone propionate (one implant con- veal. To avoid excess trim, do not sisting of 8 pellets, each pellet con- slaughter within 21 days of last injec- taining 2.5 mg estradiol benzoate and tion. 25 mg testosterone propionate) per im- [72 FR 69142, Dec. 7, 2007, as amended at 79 plant dose. FR 16187, Mar. 25, 2014; 84 FR 8973, Mar. 13, (ii) 20 mg estradiol benzoate and 200 2019] mg testosterone propionate (one implant consisting of 9 pellets, each of 8 § 522.840 Estradiol. pellets containing 2.5 mg estradiol ben- (a) Specifications. Each silicone rub- zoate and 25 mg testosterone propio- ber implant contains 25.7 or 43.9 milli- nate, and 1 pellet containing 29 mg grams (mg) estradiol and is coated with tylosin tartrate) per implant dose.

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(2) Indications for use. For increased ceive can be re-bred when they return rate of weight gain and improved feed to estrus approximately 17 to 25 days efficiency. after implant removal. Do not use in (3) Limitations. For heifers weighing cows producing milk for human con- 400 pounds or more; for subcutaneous sumption. ear implantation, one dose per animal; [47 FR 55477, Dec. 10, 1982, as amended at 48 not for use in dairy or beef replacement FR 49656, Oct. 27, 1983; 51 FR 33592, Sept. 22, heifers. Safety and effectiveness have 1986; 54 FR 1165, Jan. 12, 1989; 84 FR 39184, not been established in veal calves. A Aug. 9, 2019; 84 FR 32992, July 11, 2019] withdrawal period has not been established for this product in § 522.863 Ethylisobutrazine. preruminating calves. Do not use in (a) Specifications. Each milliliter of calves to be processed for veal. solution contains 50 milligrams (mg) of [69 FR 68252, Nov. 24, 2004, as amended at 77 ethylisobutrazine hydrochloride. FR 31723, May 30, 2012; 79 FR 16187, Mar. 25, (b) Sponsor. See No. 000061 in 2014; 81 FR 48702, July 26, 2016] § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) § 522.850 Estradiol valerate and Amount. Administer 2 to 5 mg per norgestomet in combination. pound of body weight by intramuscular (a) Specifications. The product is a injection for profound tranquilization. two-component drug consisting of the Administer 1 to 2 mg per pound of body following: weight by intravenous injection to ef- (1) An implant containing 6.0 milli- fect. grams of norgestomet. (2) Indications for use. For use as a (2) An injectable solution (sesame tranquilizer. oil) containing 3.0 milligrams of (3) Limitations. Federal law restricts norgestomet and 5.0 milligrams of es- this drug to use by or on the order of a tradiol valerate per 2 milliliters. licensed veterinarian. (b) Sponsor. See 000010 in § 510.600(c) of [79 FR 16187, Mar. 25, 2014] this chapter. (c) Related tolerances. See § 556.240 of § 522.870 Etodolac. this chapter. (d) Conditions of use—(1) Amount. One (a) Specifications. Each milliliter con- implant and 2 milliliters of injection at tains 100 milligrams (mg) etodolac. time of implantation. (b) Sponsor. See No. 000010 in § 510.600 (2) Indications for use. For synchroni- of this chapter. zation of estrus/ovulation in cycling (c) Conditions of use in dogs—(1) beef cattle and non-lactating dairy Amount. Administer 4.5 to 6.8 mg/pound heifers. (10 to 15 mg/kilogram) body weight as a (3) Limitations. Insert implant single, dorsoscapular subcutaneous in- subcutaneously in the ear only; then jection. If needed, the daily dose of immediately inject solution etodolac tablets as in § 520.870 of this intramuscularly only. Counting the chapter may be given 24 hours after the day of implantation as day 1, remove injection. the implant on day 10. Collect all im- (2) Indications for use. For the control plants as they are removed and burn of pain and inflammation associated them. While animals are restrained for with osteoarthritis. artificial insemination, avoid other (3) Limitations. Federal law restricts treatments such as vaccinations, dip- this drug to use by or on the order of a ping, pour-on grub and louse preven- licensed veterinarian. tion, spraying, etc. When inseminating [72 FR 51365, Sept. 7, 2007, as amended at 75 without estrus detection, the entire FR 10167, Mar. 5, 2010] treated group should be started at 48 hours after the last implant has been § 522.883 Etorphine. removed and should be completed with- (a) Specifications. Each milliliter of in 6 hours. Where estrus detection is solution contains 1 milligram of preferred, insemination should be ap- etorphine hydrochloride. proximately 12 hours after first detec- (b) Sponsor. See No. 053923 in tion of estrus. Those that do not con- § 510.600(c) of this chapter.

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(c) Special considerations. Distribution (ii) Limitations. Federal law restricts is restricted to veterinarians engaged this drug to use by or on the order of a in zoo and exotic animal practice, wild- licensed veterinarian. life management programs, and re- (2) Swine—(i) Amount. Administer a searchers. single injection of 0.25 mg (1 mL) (d) Conditions of use—(1) Amount. Ad- subcutaneously. ministered intramuscularly by hand (ii) Indications for use. For the induc- syringe or syringe dart at a suitable tion of parturition in sows and gilts dosage level depending upon the spe- pregnant at least 112 days. cies. (iii) Limitations. Federal law restricts (2) Indications for use. For the immo- this drug to use by or on the order of a bilization of wild and exotic animals. licensed veterinarian. (3) Limitations. Do not use in domestic food-producing animals. Do not use [79 FR 16188, Mar. 25, 2014] 30 days before, or during, the hunting season in free-ranging wild animals § 522.930 Firocoxib. 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. firocoxib. [79 FR 16188, Mar. 25, 2014] (b) Sponsors. See No. 000010 in § 510.600(c) of this chapter. § 522.914 Fenprostalene. (c) Conditions of use in horses—(1) (a) Specifications. (1) Each milliliter Amount. Administer 0.04 mg/pound (lb) of solution contains 0.5 milligram (mg) (0.09 mg/kilogram (kg)) of body weight fenprostalene. (BW) intravenously, once daily, for up (2) Each milliliter of solution con- to 5 days. If further treatment is need- tains 0.25 mg fenprostalene. ed, firocoxib oral paste can be adminis- (b) Sponsor. See No. 054771 in tered at a dosage of 0.045 mg/lb (0.1 mg/ § 510.600(c) of this chapter for use of kg) of BW for up to an additional 9 product described in paragraph (a)(1) as days of treatment. in paragraph (e)(1) of this section; and (2) Indications for use. For the control for use of product described in para- of pain and inflammation associated graph (a)(2) as in paragraph (e)(2) of with osteoarthritis. this section. (3) Limitations. Do not use in horses (c) Related tolerances. See § 556.277 of intended for human consumption. Fed- this chapter. eral law restricts this drug to use by or (d) Special considerations. Labeling on the order of a licensed veterinarian. shall bear the following statements: [75 FR 59611, Sept. 28, 2010, as amended at 84 Women of childbearing age, FR 39184, Aug. 9, 2019] asthmatics, and persons with bronchial and other respiratory problems should § 522.955 Florfenicol. exercise extreme caution when han- (a) Specifications. Each milliliter of dling this product. It is readily ab- solution contains: sorbed through the skin and may cause abortion and/or bronchiospasms. Acci- (1) 300 milligrams (mg) florfenicol in dental spillage on the skin should be the inactive vehicles 2-pyrrolidone and washed off immediately with soap and triacetin. water. (2) 300 mg florfenicol in the inactive (e) Conditions of use—(1) Cattle—(i) In- vehicles n-methyl-2-pyrrolidone, pro- dications for use and amount—(A) For pylene glycol, and polyethylene glycol. feedlot heifers to induce abortion when (3) 300 mg florfenicol in the inactive pregnant 150 days or less, administer 1 vehicles 2-pyrrolidone and glycerol for- mg (2 milliliter (mL)) subcutaneously. mal. (B) For beef or nonlactating dairy (b) Sponsors. See sponsor numbers in cattle for estrus synchronization, ad- § 510.600(c) of this chapter: minister a single or two 1-mg (2-mL) (1) No. 000061 for use of product de- doses subcutaneously, 11 to 13 days scribed in paragraph (a)(1) as in para- apart. graph (d)(1)(i); and

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(2) Nos. 000061 and 000859 for use of Mannheimia (Pasteurella) haemolytica, P. product described in paragraph (a)(2) as multocida, and Haemophilus somnus. in paragraph (d)(1)(ii). (C) Limitations. Animals intended for (3) No. 055529 for use of product de- human consumption must not be scribed in paragraph (a)(3) as in para- slaughtered within 28 days of the last graph (d)(1)(ii). intramuscular treatment. Animals in- (c) Related tolerances. See §§ 500.1410 tended for human consumption must and 556.283 of this chapter. not be slaughtered within 33 days of (d) Conditions of use—(1) Beef and non- subcutaneous treatment. This product lactating dairy cattle. (i) 300 mg per mil- is not approved for use in female dairy liliter (mL) florfenicol in the inactive cattle 20 months of age or older, in- vehicles 2-pyrrolidone and triacetin: cluding dry dairy cows. Use in these (A) Amount. 40 mg/kilogram (kg) body cattle may cause drug residues in milk weight as a single subcutaneous injec- and/or in calves born to these cows. A tion. withdrawal period has not been estab- (B) Indications for use. For treatment lished in pre-ruminating calves. Do not of bovine respiratory disease (BRD) as- use in calves to be processed for veal. sociated with Mannheimia haemolytica, Federal law restricts this drug to use Pasteurella multocida, Histophilus somni, by or on the order of a licensed veteri- and Mycoplasma bovis in beef and non- narian. lactating dairy cattle. (2) [Reserved] (C) Limitations. Animals intended for [73 FR 21041, Apr. 18, 2008, as amended at 74 human consumption must not be FR 66574, Dec. 16, 2009; 79 FR 18158, Apr. 1, slaughtered within 44 days of treat- 2014; 79 FR 53136, Sept. 8, 2014; 80 FR 61296, ment. Do not use in female dairy cattle Oct. 13, 2015; 80 FR 76386, Dec. 9, 2015] 20 months of age or older. Use of florfenicol in this class of cattle may § 522.956 Florfenicol and flunixin. cause milk residues. A withdrawal pe- (a) Specifications. Each milliliter riod has not been established in pre-ru- (mL) of solution contains 300 milli- minating calves. Do not use in calves grams (mg) florfenicol and 16.5 mg to be processed for veal. Federal law re- flunixin (27.37 mg flunixin meglumine). stricts this drug to use by or on the (b) Sponsor. See No. 000061 in order of a licensed veterinarian. § 510.600(c) of this chapter for use as in (ii) 300 mg/mL florfenicol in the inac- paragraph (d) of this section. tive vehicles n-methyl-2- pyrrolidone, (c) Tolerances. See §§ 556.283 and propylene glycol, and polyethylene gly- 556.286 of this chapter. col, or in 2-pyrrolidone and glycerol (d) Conditions for use in cattle—(1) formal: Amount. 40 mg florfenicol/kg body (A)(1) Amount. 20 mg/kg of body weight (BW) and 2.2 mg flunixin/kg BW weight as an intramuscular injection. (equivalent to 2 mL/15 kg BW or 6 mL/ A second dose should be administered 100 lbs) once, by subcutaneous injec- 48 hours later. Alternatively, 40 mg/kg tion. of body weight as a single subcuta- (2) Indications for use. For treatment neous injection may be used. of bovine respiratory disease (BRD) as- (2) Indications for use. For treatment sociated with Mannheimia haemolytica, of BRD associated with Mannheimia Pasteurella multocida, Histophilus somni, (Pasteurella) haemolytica, P. multocida, and Mycoplasma bovis, and control of and Haemophilus somnus. For treatment BRD-associated pyrexia in beef and of bovine interdigital phlegmon (foot non-lactating dairy cattle. rot, acute interdigital necrobacillosis, (3) Limitations. Animals intended for infectious pododermatitis) associated human consumption must not be with Fusobacterium necrophorum and slaughtered within 38 days of treat- Bacteroides melaninogenicus. ment. This drug product is not ap- (B)(1) Amount. 40 mg/kg of body proved for use in female dairy cattle 20 weight as a single subcutaneous injec- months of age or older, including dry tion. dairy cows. Use in these cattle may (2) Indications for use. For control of cause drug residues in milk and/or in respiratory disease in cattle at high calves born to these cows. A with- risk of developing BRD associated with drawal period has not been established

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in preruminating calves. Do not use in (2) Indications for use. For use in cer- calves to be processed for veal. Federal tain acute and chronic canine law restricts this drug to use by or on dermatoses of varying etiology to help the order of a licensed veterinarian. control the pruritus, irritation, and inflammation associated with these con- [75 FR 1275, Jan. 11, 2010, as amended at 75 ditions. FR 54018, Sept. 3, 2010; 79 FR 18158, Apr. 1, 2014] (3) Limitations. Federal law restricts this drug to use by or on the order of a § 522.960 Flumethasone injectable dos- licensed veterinarian. age forms. [79 FR 16188, Mar. 25, 2014]

§ 522.960a Flumethasone suspension. § 522.960c Flumethasone solution. (a) Specifications. Each milliliter of (a) Specifications. Each milliliter of suspension contains 2 milligrams (mg) solution contains 0.5 milligrams (mg) of flumethasone. of flumethasone. (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 horses—(1) (c) Conditions of use. It is used as fol- Amount. Administer 6 to 10 mg by lows: intra-articular injection. Dosage is (1) Horses—(i) Amount. Administer limited to a single injection per week 1.25 to 2.5 milligrams (mg) daily by in- in any one synovial structure. travenous, intramuscular, or intra-ar- (2) Indications for use. For use in the ticular injection. various disease states involving (ii) Indications for use. For use in the synovial structures (joints) of horses treatment of musculoskeletal condi- where excessive synovial fluid of in- tions due to inflammation, where per- flammatory origin is present and where manent structural changes do not permanent structural changes do not exist, e.g., bursitis, carpitis, osselets, exist. Such conditions include arthri- and myositis; and allergic states, e.g., tis, carpitis, and osselets. hives, urticaria, and insect bites. (3) Limitations. Do not use in horses (iii) Limitations. Do not use in horses intended for human consumption. Fed- intended for human consumption. Fed- eral law restricts this drug to use by or eral law restricts this drug to use by or on the order of a licensed veterinarian. on the order of a licensed veterinarian. (2) Dogs—(i) Amount. Administer [79 FR 16188, Mar. 25, 2014] 0.0625 to 0.25 mg daily by intravenous, intramuscular, or subcutaneous injec- § 522.960b Flumethasone acetate solution; 0.125 to 1.0 mg daily by intra- tion. lesional injection, depending on the (a) Specifications. Each milliliter of size and location of the lesion; or 0.166 solution contains 2 milligrams (mg) of to 1.0 mg daily by intra-articular injec- flumethasone acetate. tion, depending on the severity of the (b) Sponsor. See No. 054771 in condition and the size of the involved § 510.600(c) of this chapter. 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,

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and insect bites; and shock and shock- (B) Administer 2.2 mg/kg (1.0 mg/lb) like states by intravenous administra- of body weight once intravenously for tion. control of pyrexia associated with (iii) Limitations. Federal law restricts acute bovine mastitis. this drug to use by or on the order of a (ii) Limitations. Approved only for in- licensed veterinarian. travenous administration in cattle. (3) Cats—(i) Amount. Administer Intramuscular administration has re- 0.03125 to 0.125 mg daily by intravenous, sulted in violative residues in the edi- intramuscular, or subcutaneous injec- ble tissues of cattle sent to slaughter. tion. Cattle must not be slaughtered for (ii) Indications for use. For use in the human consumption within 4 days of treatment of certain acute and chronic last treatment. Milk that has been dermatoses of varying etiology to help taken during treatment and for 36 control associated pruritus, irritation, hours after the last treatment must and inflammation. not be used for food. Do not use in dry (iii) Limitations. Federal law restricts dairy cows. A withdrawal period has this drug to use by or on the order of a not been established for use in licensed veterinarian. preruminating calves. Do not use in [79 FR 16188, Mar. 25, 2014] calves to be processed for veal. (B) [Reserved] § 522.970 Flunixin. (3) Swine—(i) Amount. Administer 2.2 (a) Specifications. Each milliliter of mg/kg (1.0 mg/lb) of body weight as a solution contains flunixin meglumine single intramuscular injection. equivalent to 50 milligrams (mg) (ii) Indications for use. For the control flunixin. of pyrexia associated with swine res- (b) Sponsors. See sponsors in piratory disease. § 510.600(c) of this chapter for use as in (iii) Limitations. Swine must not be paragraph (e) of this section. slaughtered for human consumption (1) See Nos. 000061, 000859, 016592, within 12 days of last treatment. 055529, and 061133 for use as in para- [42 FR 39103, Aug. 2, 1977, as amended at 52 graph (e) of this section. FR 7832, Mar. 13, 1987; 60 FR 54942, Oct. 27, (2) See No. 054771 for use as in para- 1995; 62 FR 22888, Apr. 28, 1997; 63 FR 38749, graph (e)(1) of this section. July 20, 1998; 67 FR 9400, Mar. 1, 2002; 68 FR (c) Related tolerances. See § 556.286 of 70701, Dec. 19, 2003; 69 FR 53618, Sept. 2, 2004; this chapter. 69 FR 60308, Oct. 8, 2004; 70 FR 48868, Aug. 22, (d) Special considerations. Federal law 2005; 70 FR 70998, Nov. 25, 2005; 71 FR 15564, Mar. 29, 2006; 71 FR 16222, Mar. 31, 2006; 73 FR restricts this drug to use by or on the 2809, Jan. 16, 2008; 73 FR 28037, May 15, 2008; order of a licensed veterinarian. 74 FR 6994, Feb. 12, 2009; 74 FR 34236, July 15, (e) Conditions of use—(1) Horses—(i) 2009; 75 FR 13225, Mar. 19, 2010; 75 FR 76260, Amount. 0.5 mg per pound (/lb) of body Dec. 8, 2010; 79 FR 16189, Mar. 25, 2014; 82 FR weight per day, intravenously or 43484, Sept. 18, 2017; 83 FR 48946, Sept. 28, intramuscularly, for up to 5 days. 2018; 84 FR 8973, Mar. 13, 2019] (ii) Indications for use. For alleviation of inflammation and pain associated § 522.995 Fluprostenol. with musculoskeletal disorders, and al- (a) Specifications. Each milliliter of leviation of visceral pain associated solution contains fluprostenol sodium with colic. equivalent to 50 micrograms (μg) of (iii) Limitations. Do not use in horses fluprostenol. intended for human consumption. (b) Sponsor. See No. 000859 in (2) Cattle—(i) Amounts and indications § 510.600(c) of this chapter. for use—(A) Administer 1.1 to 2.2 mg/ (c) Conditions of use in horses—(1) kilogram (kg) (0.5 to 1.0 mg/lb) of body Amount. Administer 0.55 μg fluprostenol weight per day intravenously, as a sin- per kilogram of body weight by gle dose or divided into two doses ad- intramuscular injection. ministered at 12-hour intervals, for up (2) Indications for use. For use in to 3 days for control of pyrexia associ- mares for its luteolytic effect to con- ated with bovine respiratory disease trol the timing of estrus in estrous cy- and endotoxemia or for control of in- cling and in clinically anestrous mares flammation in endotoxemia. that have a corpus luteum.

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(3) Limitations. Do not use in horses conjunction with the 6th dose, admin- intended for human consumption. Fed- ister an approved prostaglandin prod- eral law restricts this drug to use by or uct for cattle (cloprostenol sodium or on the order of a licensed veterinarian. dinoprost tromethamine), using the la- [79 FR 16189, Mar. 25, 2014] beled dosage and administration instructions to cause luteolysis and in- § 522.1002 Follicle stimulating hor- duce estrus. See § 522.460 for use of mone. cloprostenol sodium or § 522.690 for use (a)(1) Specifications. Each package of dinoprost tromethamine. contains 2 vials. One vial contains dry, (ii) Indications for use. For the induc- powdered, porcine pituitary gland tion of superovulation in beef and dairy equivalent to 75 units (NIH-FSH-S1) of heifers and cows. follicle stimulating hormone. The (iii) Limitations. Federal law restricts other vial contains 10 milliliters of this drug to use by or on the order of a aqueous diluent. licensed veterinarian. (2) Sponsor. See No. 052923 in § 510.600(c) of this chapter. [58 FR 47377, Sept. 9, 1993, as amended at 62 (3) Conditions of use—(i) Dosage. 12.5 FR 62242, Nov. 21, 1997; 76 FR 2808, Jan. 18, units of follicle stimulating hormone 2011; 79 FR 53136, Sept. 8, 2014; 79 FR 74020, twice a day for 3 days (a total of 75 Dec. 15, 2014; 82 FR 21690, May 10, 2017; 82 FR 43484, Sept. 18, 2017] units). To effect regression of the corpus luteum, prostaglandin should be § 522.1010 Furosemide. given with the 5th dose. (ii) Indications for use. For induction (a) Specifications. (1) Each milliliter of superovulation in cows for proce- (mL) of solution contains 50 milligrams dures requiring the production of mul- (mg) furosemide monoethanolamine. tiple ova at a single estrus. (2) Each mL of solution contains 50 (iii) Limitations. For intramuscular mg furosemide diethanolamine. use in cows that are not pregnant and (b) Sponsors. See sponsors in have a normal corpus luteum. Federal § 510.600(c) of this chapter for use of law restricts this drug to use by or on products described in paragraph (a) of the order of a licensed veterinarian. this section for use as in paragraph (d) (b)(1) Specifications—(i) Single pack. of this section. Each package contains 2 vials. One vial (1) No. 000010 as described in para- contains 700 international units (IU) graph (a)(1) of this section for use as in porcine-pituitary-derived follicle stim- paragraphs (d)(1) and (d)(2)(ii) of this ulating hormone (FSH) equivalent to section. 400 milligrams NIH–FSH–P1, as a dry (2) No. 061133 as described in para- powder. The other vial contains 20 mil- graph (a)(2) of this section for use as in liliters (mL) of bacteriostatic sodium paragraph (d)(2)(ii) of this section. chloride injection. When constituted, (3) No. 000859 as described in para- each milliliter of solution contains 35 graph (a)(2) for use as in paragraphs IU FSH. (d)(1), (d)(2)(i), and (d)(3) of this sec- (ii) Dual pack. Each package contains tion. 2 vials. Each vial contains 700 international units (IU) porcine-pituitary- (4) No. 000061 as described in para- derived FSH equivalent to 400 milli- graph (a)(2) for use as in paragraphs grams NIH–FSH–P1, as a dry powder. (d)(1), (d)(2)(iii), and (d)(3) of this sec- Constitute with 20 mL bacteriostatic tion. sodium chloride injection, using strict (c) Special considerations. Federal law aseptic technique. When constituted, restricts this drug to use by or on the each milliliter of solution contains 35 order of a licensed veterinarian. IU FSH. (d) Conditions of use—(1) Dogs and (2) Sponsor. See No. 017030 in cats—(i) Amount. 1.25 to 2.5 mg per § 510.600(c) of this chapter. pound (/lb) body weight once or twice (3) Conditions of use—(i) Dosage. Ad- daily, intramuscularly or intra- minister 2.5 mL (87.5 IU) venously. intramuscularly, twice daily at 12-hour (ii) Indications for use. For the treat- intervals, for 4 consecutive days. In ment of edema (pulmonary congestion,

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ascites) associated with cardiac insuffi- § 522.1014 Gamithromycin. ciency and acute noninflammatory tis- (a) Specifications. Each milliliter sue edema. (mL) of solution contains 150 milli- (2) Horses—(i) Amount. 250 to 500 mg grams (mg) gamithromycin. per animal once or twice daily, (b) Sponsor. See No. 000010 in intramuscularly or intravenously. § 510.600(c) of this chapter. (A) Indications for use. For the treat- (c) Related tolerances. See § 556.292 of ment of edema (pulmonary congestion, this chapter. ascites) associated with cardiac insuffi- (d) Conditions of use—(1) Cattle—(i) ciency, and acute noninflammatory tis- Amount. Administer 6 mg/kilogram of sue edema. body weight (2 mL per 110 pounds) one (B) Limitations. Do not use in horses time by subcutaneous injection in the intended for human consumption. neck. (ii) Amount. 0.5 mg/lb body weight (ii) Indications for use. For the treat- once or twice daily, intramuscularly or ment of bovine respiratory disease intravenously. (BRD) associated with Mannheimia (A) Indications for use. For treatment haemolytica, Pasteurella multocida, of acute noninflammatory tissue Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy cattle; edema. and for the control of respiratory dis- (B) Do not use in horses Limitations. ease in beef and non-lactating dairy intended for human consumption. cattle at high risk of developing BRD (iii) Amount. 250 to 500 mg/animal associated with M. haemolytica and P. once or twice daily, intramuscularly or multocida. intravenously. (iii) Limitations. Cattle intended for (A) Indications for use. For the treat- human consumption must not be ment of edema (pulmonary congestion, slaughtered within 35 days from the ascites) associated with cardiac insuffi- last treatment. Do not use in female ciency, and acute noninflammatory tis- dairy cattle 20 months of age or older. sue edema. A withdrawal period has not been es- (B) Limitations. Do not use in horses tablished for this product in intended for human consumption. preruminating calves. Do not use in (3) Cattle—(i) Amount. 500 mg/animal calves to be processed for veal. Federal once daily, intramuscularly or intra- law restricts this drug to use by or on venously; or 250 mg/animal twice daily the order of a licensed veterinarian. at 12-hour intervals, intramuscularly (2) [Reserved] or intravenously. [76 FR 57906, Sept. 19, 2011, as amended at 77 (ii) Indications for use. For the treat- FR 26162, May 3, 2012; 84 FR 39184, Aug. 9, ment of physiological parturient 2019] edema of the mammary gland and asso- § 522.1020 Gelatin. ciated structures. (iii) Limitations. Treatment not to ex- (a) Specifications. Each 100 milliliters ceed 48 hours post-parturition. Milk contains 8 grams of gelatin in a 0.85 taken during treatment and for 48 percent sodium chloride solution. (b) Sponsor. See No. 054771 in hours (four milkings) after the last § 510.600(c) of this chapter. treatment must not be used for food. (c) Conditions of use—(1) Amount. The Cattle must not be slaughtered for food exact dosage to be administered must within 48 hours following last treat- be determined after evaluating the ani- ment. mal’s condition and will vary according [66 FR 47961, Sept. 17, 2001, as amended at 67 to the size of the animal and the degree FR 18086, Apr. 15, 2002; 68 FR 59881, Oct. 20, of shock. A suggested dosage range for 2003; 69 FR 17585, Apr. 5, 2004; 71 FR 39548, small animals such as dogs is 4 to 8 July 13, 2006; 74 FR 61516, Nov. 25, 2009; 76 FR cubic centimeters per pound body 17338, Mar. 29, 2011; 78 FR 17597, Mar. 22, 2013; weight. The suggested dosage range for 79 FR 16189, Mar. 25, 2014; 84 FR 8973, Mar. 13, large animals such as sheep, calves, 2019] cows, or horses is 2 to 4 cubic centimeters per pound of body weight.

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(2) Indications for use. For use to re- (iii) Limitations. Administer store circulatory volume and maintain intramuscularly or subcutaneously. If blood pressure in animals being treated response is not noted after 7 days, the for shock. antibiotic sensitivity of the infecting (3) Limitations. Federal law restricts organism should be retested. Federal this drug to use by or on the order of a law restricts this drug to use by or on licensed veterinarian. the order of a licensed veterinarian. (2) Turkeys—(i) Amount. One milli- [79 FR 16189, Mar. 25, 2014] gram of gentamicin per 0.2 milliliter § 522.1044 Gentamicin. dose, using the 50- or 100-milligrams- per-milliliter product diluted with (a) Specifications. Each milliliter of sterile saline to a concentration of 5 solution contains gentamicin sulfate milligrams-per-milliliter. equivalent to 5, 50, or 100 milligrams (ii) Indications for use. As an aid in (mg) gentamicin. the prevention of early mortality due (b) Sponsors. See sponsors in to Arizona paracolon infections suscep- § 510.600(c) of this chapter for use as in tible to gentamicin. paragraph (d) of this section. (iii) Limitations. For 1- to 3-day old (1) No. 000061 for use of 5 mg per mil- turkey poults. Administer liliter (/mL) solution in swine as in subcutaneously in the neck. Injected paragraph (d)(4), 50 mg/mL solution in poults must not be slaughtered for food dogs and cats as in paragraph (d)(1), 50 for at least 9 weeks after treatment. mg/mL and 100 mg/mL solution in (3) Chickens—(i) Amount. 0.2 milli- chickens and turkeys as in paragraphs gram of gentamicin per 0.2 milliliter (d)(2) and (d)(3) of this section. dose, using the 50- or 100-milligrams- (2) No. 058005 for use of 5 mg/mL solu- per-milliliter product diluted with tion in swine as in paragraph (d)(4) of sterile saline to a concentration of 1.0 this section. milligram-per-milliliter. (3) No. 069043 for use of 50 mg/mL so- (ii) Indications for use. In day-old lution in dogs as in paragraph (d)(5) of chickens, for prevention of early mor- this section. tality caused by Escherichia coli. Sal- (4) Nos. 016592 and 061133 for use of 100 monella typhimurium, and Pseudomonas mg/mL solution in turkeys as in para- aeruginosa that are susceptible to graph (d)(2) and in chickens as in para- gentamicin. graph (d)(3) of this section. (iii) Limitations. For use in day-old (c) Related tolerances. See § 556.300 of chickens only. Administer aseptically, this chapter. injecting the diluted product (d) Conditions of use—(1) Dogs and subcutaneously in the neck. Do not cats—(i) Amount. Two milligrams of slaughter treated animals for food for gentamicin per pound of body weight, at least 5 weeks after treatment. twice daily on the first day, once daily (4) Swine—(i) Amount. 5 milligrams of thereafter, using a 50 milligram-per- gentamicin as a single intramuscular milliliter solution. dose using 5 milligram-per-milliliter (ii) Indications for use—(a) Dogs. For solution. the treatment of infections of urinary (ii) Indications for use. In piglets up to tract (cystitis, nephritis), respiratory 3 days old for treatment of porcine tract (tonsillitis, pneumonia, colibacillosis caused by strains of E. tracheobronchitis), skin and soft tissue coli sensitive to gentamicin. (pyodermatitis, wounds, lacerations, (iii) Limitations. For single peritonitis). intramuscular dose in pigs up to 3 days (b) Cats. For the treatment of infec- of age only. Do not slaughter treated tions of urinary tract (cystitis, nephri- animals for food for at least 40 days fol- tis), respiratory tract (pneumonitis, lowing treatment. pneumonia, upper respiratory tract in- (5) Dogs—(i) Amount. 2 milligrams of fections), skin and soft tissue (wounds, gentamicin per pound of body weight, lacerations, peritonitis), and as sup- twice daily on the first day, then once portive therapy for secondary bacterial daily. infections associated with (ii) Indications for use. For use in the panleucopenia. treatment of urinary tract infections

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(cystitis) caused by Proteus mirabilis, tion in dogs or by intramuscular injec- Escherichia coli, and Staphylococcus tion in cats. aureus. (2) Indications for use. As a (iii) Limitations. Administer preanesthetic agent. intramuscularly or subcutaneously. If (3) Limitations. Federal law restricts no improvement is seen after 3 days, this drug to use by or on the order of a treatment should be discontinued and licensed veterinarian. the diagnosis reevaluated. Treatment [71 FR 64451, Nov. 2, 2006, as amended at 78 not to exceed 7 days. Federal law re- FR 17597, Mar. 22, 2013; 79 FR 16189, Mar. 25, stricts this drug to use by or on the 2014; 81 FR 17608, Mar. 30, 2016] order of a licensed veterinarian. § 522.1077 Gonadorelin. [43 FR 1942, Jan. 13, 1978, as amended at 48 FR 791, Jan. 7, 1983; 51 FR 15606, Apr. 25, 1986; (a) Specifications. Each milliliter 52 FR 7832, Mar. 13, 1987; 53 FR 40727, Oct. 18, (mL) of solution contains: 1988; 60 FR 29985, June 7, 1995; 61 FR 24441, (1) 43 micrograms (μg) of gonadorelin May 15, 1996; 62 FR 45157, Aug. 26, 1997; 63 FR as gonadorelin acetate; 59714, Nov. 5, 1998; 63 FR 68182, Dec. 10, 1998; (2) 100 μg of gonadorelin as 65 FR 45877, July 26, 2000; 71 FR 76901, Dec. 22, gonadorelin acetate; 2006; 78 FR 17597, Mar. 22, 2013; 78 FR 21060, (3) 43 μg of gonadorelin as Apr. 9, 2013; 79 FR 21127, Apr. 15, 2014; 81 FR 22524, Apr. 18, 2016; 83 FR 48946, Sept. 28, 2018; gonadorelin diacetate tetrahydrate; or 84 FR 8973, Mar. 13, 2019] (4) 50 μg of gonadorelin as gonadorelin hydrochloride. § 522.1055 Gleptoferron. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter. (a) Specifications. Each milliliter μ (mL) contains the equivalent of 200 (1) No. 000061 for use of the 43- g/mL milligrams of elemental iron as product described in paragraph (a)(1) as gleptoferron, a complex of ferric hy- in paragraphs (d)(1)(i), (d)(1)(iv), and (d)(2) of this section. droxide and dextran glucoheptonic μ acid. (2) No. 068504 for use of the 100- g/mL product described in paragraph (a)(2) as (b) Sponsors. See No. 013744 in in paragraphs (d)(1)(ii), (d)(1)(v), and § 510.600(c) of this chapter. (d)(2) of this section. (c) Conditions of use in swine—(1) Indi- (3) No. 061133 for use of the 43-μg/mL cations for use and amounts. (i) Preven- product described in paragraph (a)(3) as tion of anemia due to iron deficiency: in paragraphs (d)(1)(i) and (d)(2) of this Administer 1 mL (200 mg iron) per pig section. by intramuscular injection on or before (4) No. 000010 for use of the 43-μg/mL 3 days of age. product described in paragraph (a)(3) as (ii) Treatment of anemia due to iron in paragraphs (d)(1)(i), (d)(1)(vi), and deficiency: Administer 1 mL (200 mg (d)(2) of this section. iron) per pig by intramuscular injec- (5) No. 054771 for use of the 50-μg/mL tion as soon as signs of deficiency ap- product described in paragraph (a)(4) as pear. in paragraphs (d)(1)(iii), (d)(1)(vii), and (2) [Reserved] (d)(2) of this section. [81 FR 59134, Aug. 29, 2016, as amended at 82 (c) Related tolerances. See § 556.304 of FR 11508, Feb. 24, 2017; 82 FR 21690, May 10, this chapter. 2017] (d) Special considerations. Concurrent luteolytic drug use is approved as fol- § 522.1066 Glycopyrrolate. lows: (a) Specifications. Each milliliter of (1) Cloprostenol injection for use as solution contains 0.2 milligram in paragraph (d)(1)(iv) of this section as glycopyrrolate. provided by No. 000061 in § 510.600(c) of (b) Sponsors. See Nos. 054771 and this chapter. 069043 in § 510.600(c) of this chapter. (2) Cloprostenol injection for use as (c) Conditions of use in dogs and cats— in paragraph (d)(1)(v) and (d)(1)(vi) of (1) Amount. 5 micrograms per pound of this section as provided by No. 000061 or body weight (0.25 milliliter per 10 No. 068504 in § 510.600(c) of this chapter. pounds of body weight) by intravenous, (3) Dinoprost injection for use as in intramuscular, or subcutaneous injec- paragraph (d)(1)(vii) of this section as

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provided by No. 054771 in § 510.600(c) of gonadorelin by intramuscular injec- this chapter. tion, followed 6 to 8 days later by 25 mg (e) Conditions of use in cattle—(1) Indi- dinoprost by intramuscular injection, cations for use and amounts. (i) For the followed 30 to 72 hours later by 100 to treatment of ovarian follicular cysts in 200 μg gonadorelin by intramuscular in- dairy cattle: Administer 86 μg jection. gonadorelin (No. 000061) or 100 μg (2) Limitations. Federal law restricts gonadorelin diacetate tetrahydrate this drug to use by or on the order of a (Nos. 061623 and 050604) by licensed veterinarian. intramuscular or intravenous injec- [83 FR 64740, Dec. 18, 2018, as amended at 84 tion. FR 8973, Mar. 13, 2019; 84 FR 39184, Aug. 9, (ii) For the treatment of ovarian fol- 2019; 84 FR 32992, July 11, 2019] licular cysts in dairy cattle: Admin- ister 100 μg gonadorelin by § 522.1079 Serum gonadotropin and intramuscular or intravenous injec- chorionic gonadotropin. tion. (a) Specifications. Each dose consists (iii) For the treatment of ovarian fol- of 400 international units (I.U.) serum licular cysts in cattle: Administer 100 gonadotropin and 200 I.U. chorionic μg gonadorelin by intramuscular injec- gonadotropin as a freeze-dried powder tion. to be reconstituted with 5 milliliters of (iv) For use with cloprostenol injec- sterile aqueous diluent. tion to synchronize estrous cycles to (b) Sponsor. See No. 000061 in allow for fixed-time artificial insemi- § 510.600(c) of this chapter. nation (FTAI) in lactating dairy cows: (c) Related tolerances. See § 556.304 of Administer to each cow 86 μg this chapter. gonadorelin by intramuscular injec- (d) Conditions of use in swine—(1) tion, followed 6 to 8 days later by 500 μg Amount. 400 I.U. serum gonadotropin cloprostenol by intramuscular injec- with 200 I.U. chorionic gonadotropin tion, followed 30 to 72 hours later by 86 per 5 milliliters dose per animal. μg gonadorelin by intramuscular injec- (2) Indications for use—(i) Gilts. For tion. induction of fertile estrus (heat) in (v) For use with cloprostenol sodium healthy prepuberal (noncycling) gilts. to synchronize estrous cycles to allow (ii) Sows. For induction of estrus in for fixed-time artificial insemination healthy weaned sows experiencing de- (FTAI) in lactating dairy cows and beef layed return to estrus. cows: Administer to each cow 100 μg (3) Limitations. For subcutaneous use gonadorelin by intramuscular injec- only. tion, followed 6 to 8 days later by 500 μg (i) Gilts. For use only in gilts over 51⁄2 cloprostenol by intramuscular injec- months of age and weighing at least 85 tion, followed 30 to 72 hours later by 100 kilograms (187 pounds). μg gonadorelin by intramuscular injec- (ii) Sows. Delayed return to estrus is tion. most prevalent after the first litter. (vi) For use with cloprostenol sodium The effectiveness has not been estab- to synchronize estrous cycles to allow lished after later litters. Delayed re- for fixed-time artificial insemination turn to estrus often occurs during peri- (FTAI) in lactating dairy cows and beef ods of adverse environmental condi- cows: Administer to each cow 100 μg tions, and sows mated under such con- gonadorelin diacetate tetrahydrate by ditions may farrow smaller than nor- intramuscular injection, followed 6 to 8 mal litters. days later by 500 μg cloprostenol by [55 FR 1405, Jan. 16, 1990, as amended at 58 intramuscular injection, followed 30 to FR 52222, Oct. 7, 1993; 74 FR 61516, Nov. 25, 72 hours later by 100 μg gonadorelin di- 2009; 84 FR 32992, July 11, 2019] acetate tetrahydrate by intramuscular injection. § 522.1081 Chorionic gonadotropin. (vii) For use with dinoprost injection (a) Specifications. Each vial contains to synchronize estrous cycles to allow 5,000, 10,000 or 20,000 USP units of fixed-time artificial insemination lyophilized powder for constitution (FTAI) in lactating dairy cows: Admin- with accompanying diluent to a 10-mil- ister to each cow 100 to 200 μg liliter solution.

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(b) Sponsors. See sponsors in (c) Conditions of use in swine—(1) § 510.600(c) of this chapter for use as in Amount. Administer 0.4 mg (2 milliliter paragraph (d) of this section. (mL)) by subcutaneous injection no (1) No. 054771 for use as in paragraphs earlier than 9 weeks of age. A second (d)(1)(i)(A), (d)(1)(i)(B) and (d)(1)(i)(C) of subcutaneous injection of 0.4 mg (2 mL) this section. should be administered at least 4 weeks (2) [Reserved] after the first dose. (3) No. 000061 for use as in paragraphs (2) Indications for use. For the tem- (d)(1)(i)(A) and (d)(2) of this section. porary immunological castration (sup- (c) Related tolerances. See § 556.304 of pression of testicular function) and re- this chapter. duction of boar taint in intact male (d) Conditions of use—(1) Cattle—(i) pigs intended for slaughter. Amount. As a single dose. Dosage may (3) Limitations. Federal law restricts be repeated in 14 days if the animal’s this drug to use by or on the order of a behavior or examination of the ovaries licensed veterinarian. Pigs should be per rectum indicates retreatment. slaughtered no earlier than 3 weeks (A) 10,000 USP units by and no later than 10 weeks after the intramuscular injection. second dose. (B) 500 to 2,500 USP units by [76 FR 27889, May 13, 2011, as amended at 77 intrafollicular injection. FR 4227, Jan. 27, 2012; 79 FR 16189, Mar. 25, (C) 2,500 to 5,000 USP units by intra- 2014] venous injection. (ii) Indications for use. For parenteral § 522.1085 Guaifenesin powder for in- use in cows for treatment of nympho- jection. mania (frequent or constant heat) due (a) Specifications. The product is a to cystic ovaries. sterile powder containing guaifenesin. (iii) Limitations. Federal law restricts A solution is prepared by dissolving the this drug to use by or on the order of a drug in sterile water for injection to licensed veterinarian. make a solution containing 50 milli- (2) Finfish—(i) Amount. 50 to 510 IU grams of guaifenesin per milliliter of per pound of body weight for males, 67 solution. to 1,816 IU per pound of body weight for (b) Sponsors. See Nos. 037990 and females, by intramuscular injection. 054771 in § 510.600(c) of this chapter. Up to three doses may be administered. (c) Conditions of use in horses—(1) (ii) Indications for use. An aid in im- Amount. Administer 1 milliliter of pre- proving spawning function in male and pared solution per pound of body female brood finfish. weight by rapid intravenous infusion. (iii) Limitations. In fish intended for (2) Indications for use. For use as a human consumption, the total dose ad- muscle relaxant. ministered per fish (all injections com- (3) Limitations. Do not use in horses bined) should not exceed 25,000 IU intended for human consumption. Fed- chorionic gonadotropin. Federal law re- eral law restricts this drug to use by or stricts this drug to use by or on the on the order of a licensed veterinarian. order of a licensed veterinarian. [79 FR 16189, Mar. 25, 2014] [74 FR 61516, Nov. 25, 2009, as amended at 76 FR 17778, Mar. 31, 2011; 77 FR 55414, Sept. 10, § 522.1086 Guaifenesin solution. 2012; 79 FR 16189, Mar. 25, 2014; 83 FR 13635, Mar. 30, 2018] (a) Specifications. Each milliliter of solution contains 50 milligrams (mg) of § 522.1083 Gonadotropin releasing fac- guaifenesin and 50 mg of dextrose. tor analog-diphtheria toxoid con- (b) Sponsors. See Nos. 000859 and jugate. 037990 in § 510.600(c) of this chapter. (a) Specifications. Each milliliter of (c) Conditions of use in horses—(1) solution contains 0.2 milligrams (mg) Amount. Administer 1 milliliter per gonadotropin releasing factor analog- pound of body weight by rapid intra- diphtheria toxoid conjugate. venous infusion. (b) Sponsor. See No. 054771 in (2) Indications for use. For use as a § 510.600(c) of this chapter. skeletal muscle relaxant.

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(3) Limitations. Do not use in horses (2) Sponsor. See 054771 in § 510.600(c) of intended for human consumption. Fed- this chapter. eral law restricts this drug to use by or (3) Conditions of use—(i) Amount. on the order of a licensed veterinarian. Small and medium-size joints (carpal, [79 FR 16189, Mar. 25, 2014] fetlock): 10 mg; larger joint (hock): 20 mg. Treatment may be repeated at § 522.1125 Hemoglobin glutamer-200 weekly intervals for a total of four (bovine). treatments. (a) Specifications. Each 125 milliliter (ii) Indications for use. Treatment of bag contains 13 grams per deciliter of joint dysfunction in horses due to non- polymerized hemoglobin of bovine ori- infectious synovitis associated with gin in modified Lactated Ringer’s Solu- equine osteoarthritis. tion. It is a sterile, clear, dark purple (iii) Limitations. Do not use in horses solution. intended for human consumption. Fed- (b) Sponsor. See No. 063075 in eral law restricts this drug to use by or § 510.600(c) of this chapter. on the order of a licensed veterinarian. (c) [Reserved] (c)(1) Specifications. Each milliliter of (d) Conditions of use—(1) Amount. One- sterile aqueous solution contains 10 time dose of 10 to 30 milliliters per milligrams of hyaluronate sodium. kilogram of body weight administered (2) Sponsor. See No. 000010 in intravenously at a rate of up to 10 mil- § 510.600(c) of this chapter. liliters per kilogram per hour. (3) Conditions of use—(i) Amount. (2) Indications for use. For the treat- Small and medium-size joints (carpal, ment of anemia in dogs by increasing fetlock): 20 mg. Treatment may be re- systemic oxygen content (plasma he- peated after 1 or more weeks but not to moglobin concentration) and improv- exceed 2 injections per week for a total ing the clinical signs associated with of 4 weeks. anemia, regardless of the cause of ane- (ii) Indications for use. For the intra- mia (hemolysis, blood loss, or ineffec- articular treatment of carpal or fet- tive erythropoiesis). lock joint dysfunction in horses due to (3) Limitations. Federal law restricts acute or chronic, non-infectious syno- this drug to use by or on the order of a vitis associated with equine osteo- licensed veterinarian. arthritis. (iii) Limitations. Do not use in horses [63 FR 11598, Mar. 10, 1998, as amended at 65 FR 20732, Apr. 18, 2000; 79 FR 16189, Mar. 25, intended for human consumption. Fed- 2014] eral law restricts this drug to use by or on the order of a licensed veterinarian. § 522.1145 Hyaluronate. (d)(1) Specifications. Each milliliter of (a)(1) Specifications. Each milliliter of sterile aqueous solution contains 10 sterile aqueous solution contains 10 milligrams of hyaluronate sodium. milligrams of hyaluronate sodium. (2) Sponsor. See 000061 in § 510.600(c) of (2) Sponsor. See 054771 in § 510.600(c). this chapter. (3) Conditions of use—(i) Amount. (3) Conditions of use—(i) Amount. 50 Small and medium-size joints (carpal, milligrams in carpal and fetlock joints. fetlock): 20 mg; larger joint (hock): 40 (ii) Indications for use. For treatment mg. Treatment may be repeated at of equine carpal and fetlock joint dys- weekly intervals for a total of three function caused by traumatic and/or treatments. degenerative joint disease of mild to (ii) Indications for use. Treatment of moderate severity. joint dysfunction in horses due to non- (iii) Limitations. Do not use in horses infectious synovitis associated with intended for human consumption. Fed- equine osteoarthritis. eral law restricts this drug to use by or (iii) Limitations. Do not use in horses on the order of a licensed veterinarian. intended for human consumption. Fed- (e)(1) Specifications. Each milliliter of eral law restricts this drug to use by or solution contains: on the order of a licensed veterinarian. (i) 10 milligrams (mg) hyaluronate (b)(1) Specifications. Each milliliter of sodium; or sterile aqueous solution contains 5 mil- (ii) 10 mg hyaluronate sodium with ligrams of hyaluronate sodium. benzyl alcohol as a preservative.

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(2) Sponsors. See sponsors in § 522.1150 Hydrochlorothiazide. § 510.600(c) of this chapter: (a) Specifications. Each milliliter of (i) No. 000010 for use of products de- solution contains 25 milligrams of scribed in paragraph (e)(1) as in para- hydrochlorothiazide. graph (e)(3) of this section. (b) Sponsor. See No. 000010 in (ii) No. 017030 for use of product de- § 510.600(c) of this chapter. scribed in paragraph (e)(1)(i) as in para- (c) Conditions of use—(1) Amount. 5 to graph (e)(3) of this section. 10 milliliters (125 to 250 milligrams) in- (3) Conditions of use—(i) Amount. 20 travenously or intramuscularly once or mg of the product described in para- twice a day. After onset of diuresis, graph (e)(1)(i) of this section by intra- treatment may be continued with an articular injection into the carpus or orally administered maintenance dose. fetlock; or 40 mg of the product de- (2) Indications for use. For use in cat- scribed in paragraph (e)(1)(i) or (e)(1)(ii) tle as an aid in the treatment of of this section by slow intravenous in- postparturient udder edema. jection into the jugular vein. Treat- (3) Limitations. Milk taken from dairy ment may be repeated at weekly inter- animals during treatment and for 72 vals for a total of three treatments. hours (6 milkings) after the latest (ii) Indications for use. For treatment treatment must not be used for food. of carpal or fetlock joint dysfunction Federal law restricts this drug to use by or on the order of a licensed veteri- due to noninfectious synovitis associ- narian. ated with equine osteoarthritis. (iii) Limitations. Do not use in horses [43 FR 59058, Dec. 19, 1978, as amended at 62 intended for human consumption. Fed- FR 63271, Nov. 28, 1997; 79 FR 16190, Mar. 25, eral law restricts this drug to use by or 2014; 84 FR 39184, Aug. 9, 2019] on the order of a licensed veterinarian. § 522.1155 Imidocarb powder for injec- (f)(1) Specifications. Each milliliter of tion. sterile aqueous solution contains 11 (a) Specifications. The product is a milligrams of hyaluronate sodium. sterile powder containing imidocarb (2) Sponsor. See 060865 in § 510.600(c). dipropionate. Each milliliter of con- (3) Conditions of use—(i) Amount. stituted solution contains 100 milli- Small and medium-size joints (carpal, grams (mg) of imidocarb base. fetlock): 22 mg; larger joint (hock): 44 (b) Sponsor. See No. 000061 in mg. Treatment may be repeated at § 510.600(c) of this chapter. weekly intervals for a total of three (c) Special considerations. Imidocarb treatments. dipropionate is sold only under permit (ii) Indications for use. Treatment of issued by the Director of the National joint dysfunction in horses due to non- Program Planning Staff, Veterinary infectious synovitis associated with Services, Animal and Plant Health In- equine osteoarthritis. spection Service, U.S. Department of (iii) Limitations. Do not use in horses Agriculture, to licensed or full-time intended for human consumption. Fed- State, Federal, or military veterinar- eral law restricts this drug to use by or ians. on the order of a licensed veterinarian. (d) Conditions of use in horses and ze- bras—(1) Amount. For Babesia caballi in- [49 FR 45124, Nov. 15, 1984, as amended at 51 fections, administer 2 mg of imidocarb FR 11438, Apr. 3, 1986; 51 FR 25032, July 10, base per kilogram of body weight by 1986; 53 FR 19773, May 31, 1988; 53 FR 22297, intramuscular injection in the neck re- June 15, 1988; 56 FR 50814, Oct. 9, 1991; 57 FR gion, repeating dosage once after 24 2837, Jan. 24, 1992; 59 FR 33198, June 28, 1994; hours. For Babesia equi infections, ad- 61 FR 59003, Nov. 20, 1996; 63 FR 59216, Nov. 3, minister 4 mg of imidocarb base per 1998; 71 FR 1689, Jan. 11, 2006; 71 FR 39204, kilogram of body weight by July 12, 2006; 75 FR 1274, Jan. 11, 2010; 75 FR 10167, Mar. 5, 2010; 78 FR 73698, Dec. 9, 2013; 79 intramuscular injection in the neck re- FR 16189, Mar. 25, 2014; 79 FR 74020, Dec. 15, gion, repeating dosage four times at 72- 2014; 80 FR 34279, June 16, 2015; 84 FR 39184, hour intervals. Aug. 9, 2019] (2) Indications for use. For the treatment of babesiosis (piroplasmosis)

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caused by Babesia caballi and Babesia nalysis results, and glucose curve val- equi. ues until adequate glycemic control (3) Limitations. Do not use in horses has been attained. Twice-daily therapy intended for human consumption. Fed- should be initiated if the duration of eral law restricts this drug to use by or insulin action is determined to be inad- on the order of a licensed veterinarian. equate. If twice-daily treatment is initiated, the two doses should be 25 per- [79 FR 16190, Mar. 25, 2014] cent less than the once daily dose re- § 522.1156 Imidocarb solution. quired to attain an acceptable nadir. (B) Protamine zinc recombinant human (a) Specifications. Each milliliter of insulin. Administer a starting dose of solution contains 120 milligrams (mg) 0.2 to 0.5 IU/pound of body weight (0.5 of imidocarb dipropionate. to 1.0 IU/kg) once daily. When (b) Sponsor. See No. 000061 in transitioning from another insulin § 510.600(c) of this chapter. product, this form of insulin should be (c) Conditions of use in dogs—(1) started once daily, regardless of the Amount. Administer 6.6 mg per kilo- frequency of prior insulin use. The dose gram (3 mg per pound) of body weight should be given concurrently with or by intramuscular injection. Repeat the right after a meal. Reevaluate the dog dose after 2 weeks for a total of two at appropriate intervals and adjust the treatments. dose based on both clinical signs and (2) Indications for use. For the treat- laboratory test results until adequate ment of clinical signs of babesiosis and/ glycemic control has been attained. or demonstrated Babesia organisms in Twice-daily therapy should be initiated the blood. if the duration of insulin action is de- (3) Limitations. Federal law restricts termined to be inadequate. If twice- this drug to use by or on the order of a daily treatment is initiated, the two licensed veterinarian. doses should be 25 percent less than the [79 FR 16190, Mar. 25, 2014] once daily dose required to attain an acceptable nadir. § 522.1160 Insulin. (ii) Indications for use. For the reduc- (a) Specifications. (1) Each milliliter tion of hyperglycemia and hyper- (mL) of porcine insulin zinc suspension glycemia-associated clinical signs in contains 40 international units (IU) of dogs with diabetes mellitus. insulin. (iii) Limitations. Federal law restricts (2) Each mL of protamine zinc recom- this drug to use by or on the order of a binant human insulin suspension con- licensed veterinarian. tains 40 IU of insulin. (2) Cats—(i) Amount—(A) Porcine insu- (b) Sponsors. See sponsors in § 510.600 lin zinc. Administer an initial dose of 1 of this chapter for use as in paragraph to 2 IU by subcutaneous injection. In- (c) of this section. jections should be given twice daily at (1) No. 000061 for use of product de- approximately 12-hour intervals. For scribed in paragraph (a)(1) as in para- cats fed twice daily, the injections graphs (c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), should be concurrent with or right (c)(2)(i)(A), (c)(2)(ii), and (c)(2)(iii) of after a meal. For cats fed ad libitum, this section. no change in feeding is needed. Adjust (2) No. 000010 for use of product de- the dose at appropriate intervals based scribed in paragraph (a)(2) as in para- on clinical signs, urinalysis results, graphs (c)(1)(i)(B), (c)(1)(ii), (c)(1)(iii), and glucose curve values until ade- (c)(2)(i)(B), (c)(2)(ii), and (c)(2)(iii) of quate glycemic control has been at- this section. tained. (c) Conditions of use—(1) Dogs—(i) (B) Protamine zinc recombinant human Amount—(A) Porcine zinc insulin zinc. insulin. Administer an initial dose of Administer an initial once-daily dose 0.1 to 0.3 IU/pound of body weight (0.2 of 0.5 IU per kilogram of body weight to 0.7 IU/kilogram) every 12 hours. The by subcutaneous injection concur- dose should be given concurrently with rently with or right after a meal. Ad- or right after a meal. Re-evaluate the just this once-daily dose at appropriate cat at appropriate intervals and adjust intervals based on clinical signs, uri- the dose based on both clinical signs

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and glucose nadirs until adequate gly- (ii) For the treatment of iron defi- cemic control has been attained. ciency anemia, administer (ii) Indications for use. For the reduc- intramuscularly an amount of drug tion of hyperglycemia and hyper- containing 100 to 200 mg of elemental glycemia-associated clinical signs in iron per animal. Dosage may be re- cats with diabetes mellitus. peated in 10 days to 2 weeks. (iii) Limitations. Federal law restricts (4) No. 054771 for use of product de- this drug to use by or on the order of a scribed in paragraph (a)(1)(ii) of this licensed veterinarian. section as follows: [69 FR 25827, May 10, 2004, as amended at 73 (i) For prevention of iron deficiency FR 21042, Apr. 18, 2008; 74 FR 61517, Nov. 25, anemia, administer 1 mL by 2009; 74 FR 66048, Dec. 14, 2009; 84 FR 39184, intramuscular injection at 2 to 5 days Aug. 9, 2019] 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 young piglets 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. 016592 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 intramuscular injection. Dosage may (ii) For treatment of anemia due to be repeated in approximately 10 days. iron deficiency, administer 100 mg by (2) No. 054771 for use of product de- intramuscular injection. Treatment scribed in paragraph (a)(1)(i) of this may be repeated in 10 days. section as follows: (7) Nos. 016592 and 042552 for use of (i) For the prevention of anemia due product described in paragraph (a)(2) of to iron deficiency, administer an ini- this section as follows: tial intramuscular injection of 100 mg (i) For prevention of anemia due to at 2 to 4 days of age. Dosage may be re- iron deficiency, intramuscularly inject peated in 14 to 21 days. 200 mg of elemental iron (1 mL) at 1 to (ii) For the treatment of anemia due 3 days of age. to iron deficiency, administer an (ii) For treatment of anemia due to intramuscular injection of 200 mg. iron deficiency, intramuscularly inject (3) Nos. 000061 and 013744 for use of 200 mg of elemental iron at the first product described in paragraph (a)(1)(i) sign of anemia. of this section as follows: [73 FR 12635, Mar. 10, 2008, as amended at 73 (i) For the prevention of iron defi- FR 14385, Mar. 18, 2008; 78 FR 17597, Mar. 22, ciency anemia, administer 2013; 78 FR 44433, July 24, 2013; 79 FR 16190, intramuscularly an amount of drug Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; 81 FR containing 100 to 150 mg of elemental 59134, Aug. 29, 2016; 82 FR 11508, Feb. 24, 2017; iron to animals from 1 to 3 days of age. 83 FR 48946, Sept. 28, 2018]

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§ 522.1185 Isoflupredone. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in (a) Specifications. Each milliliter of suspension contains 2 milligrams (mg) paragraph (e) of this section. of isoflupredone acetate. (1) No. 000010 for use of the product described in paragraph (a)(1) of this (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. section as in paragraph (e)(1) of this 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 intramuscular injection. graphs (e)(2), (e)(3), (e)(4), and (e)(5) of this section; and the product described (ii) Indications for use. For use in the treatment of bovine ketosis. For allevi- in paragraph (a)(3) of this section as in ation of pain associated with general- paragraphs (e)(3) and (e)(6) of this sec- ized and acute localized arthritic con- tion. ditions; for treating acute hyper- (2) Nos. 016592, 055529, 058005, and sensitivity reactions; and as an aid in 061133 for use of the product described correcting circulatory defects associ- in paragraph (a)(2) of this section as in ated with severe toxicity and shock. paragraphs (e)(2), (e)(3), (e)(4), and (e)(5) of this section. (iii) Limitations. Animals intended for human consumption should not be (c) Related tolerances. See § 556.344 of slaughtered within 7 days of last treat- this chapter. ment. A withdrawal period has not (d) Special considerations. (1) See been established for this product in § 500.25 of this chapter. preruminating calves. Do not use in (2) Labeling shall bear the following calves to be processed for veal. Federal precaution: ‘‘This product should not law restricts this drug to use by or on be used in other animal species as se- the order of a licensed veterinarian. vere adverse reactions, including fatalities in dogs, may result.’’ (2) Horses and swine—(i) Amount—(A) (e) —(1) —(i) Horses. Administer 5 to 20 mg by Conditions of use Horses Amount. 200 micrograms per kilogram intramuscular injection for systemic μ effect or by intrasynovial injection ( g/kg) of body weight by into a joint cavity, tendon sheath, or intramuscular injection. bursa for local effect. (ii) Indications for use. For the treatment and control of large strongyles (B) Swine. The usual dose for a 300- pound animal is 5 mg by intramuscular (adult) (Strongylus vulgaris, S. edentatus, injection. Triodontophorus spp.), small strongyles (adult and fourth stage larvae) (ii) Indications for use. For alleviation of pain associated with generalized and (Cyathostomum spp., Cylicocyclus spp., acute localized arthritic conditions; for Cylicostephanus spp.), pinworms (adult treating acute hypersensitivity reac- and fourth-stage larvae) (Oxyuris equi), tions; and as an aid in correcting cir- large roundworms (adult) (Parascaris culatory defects associated with severe equorum), hairworms (adult) toxicity and shock. (Trichostrongylus axei), large mouth stomach worms (adult) ( (iii) Limitations. Animals intended for Habronema human consumption should not be muscae), neck threadworms slaughtered within 7 days of last treat- (microfilariae) (Onchocerca spp.), and ment. Federal law restricts this drug stomach bots (Gastrophilus spp.). to use by or on the order of a licensed (iii) Limitations. Not for use in horses veterinarian. intended for human consumption. Fed- eral law restricts this drug to use by or [79 FR 16190, Mar. 25, 2014] on the order of a licensed veterinarian. (2) Cattle—(i) Amount. 200 μg/kg of § 522.1192 Ivermectin. body weight by subcutaneous injection. (a) Specifications. (1) Each milliliter (ii) Indications for use. For the treat- (mL) of solution contains 20 milligrams ment and control of gastrointestinal (mg) ivermectin. nematodes (adults and fourth-stage lar- (2) Each mL of solution contains 10 vae) (Haemonchus placei, Ostertagia mg ivermectin. ostertagi (including inhibited larvae), O. (3) Each mL of solution contains 2.7 lyrata, Trichostrongylus axei, T. mg ivermectin. colubriformis, Cooperia oncophora, C.

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punctata, C. pectinata, Oesophagostomum (6) Ranch-raised foxes—(i) Amount. 200 radiatum, Nematodirus helvetianus μg/kg of body weight by subcutaneous (adults only), N. spathiger (adults only), injection. Repeat in 3 weeks. Bunostomum phlebotomum); lungworms (ii) Indications for use. For treatment (adults and fourth-stage larvae) and control of ear mites (Otodectes (Dictyocaulus viviparus); grubs (para- cynotis). sitic stages) (Hypoderma bovis, H. lineatum); sucking lice (Linognathus [72 FR 27735, May 17, 2007, as amended at 72 FR 62771, Nov. 7, 2007; 74 FR 9049, Mar. 2, 2009; vituli, Haematopinus eurysternus, 75 FR 26647, May 12, 2010; 76 FR 57906, Sept. Solenopotes capillatus); mites (scabies) 19, 2011; 78 FR 17597, Mar. 22, 2013; 81 FR 59134, (Psoroptes ovis (syn. P. communis var. Aug. 29, 2016; 84 FR 8974, Mar. 13, 2019; 84 FR bovis), Sarcoptes scabiei var. bovis). For 32992, July 11, 2019; 84 FR 39184, Aug. 9, 2019] control of infections and to protect from reinfection with D. viviparus and § 522.1193 Ivermectin and clorsulon. O. radiatum for 28 days after treatment; (a) Specifications. Each milliliter O. ostertagi, T. axei, and C. punctata for (mL) of solution contains 10 milligrams 21 days after treatment; H. placei and (mg) (1 percent) ivermectin and 100 mg C. oncophora for 14 days after treat- (10 percent) clorsulon. ment. (b) Sponsors. See Nos. 000010, 055529, (iii) Limitations. Do not treat cattle 058005, and 061133 in § 510.600(c) of this within 35 days of slaughter. Because a chapter. withdrawal time in milk has not been (c) Related tolerances. See §§ 556.163 established, do not use in female dairy and 556.344 of this chapter. cattle of breeding age. A withdrawal (d) Special considerations. See § 500.25 period has not been established for this of this chapter. product in pre-ruminating calves. Do not use in calves to be processed for (e) Conditions of use in cattle—(1) veal. Amount. Administer 1 mL (10 mg ivermectin and 100 mg clorsulon) per 50 (3) Swine—(i) Amount. 300 μg/kg of kilograms (110 pounds) by subcuta- body weight by subcutaneous injection. neous injection. (ii) Indications for use. For the treat- (2) Indications for use. For the treatment and control of gastrointestinal ment and control of gastrointestinal roundworms (adults and fourth-stage nematodes (adults and fourth-stage lar- larvae) (large roundworm, Ascaris suum; vae) (Haemonchus placei, Ostertagia red stomach worm, Hyostrongylus ostertagi (including inhibited larvae), O. rubidus; nodular worm, lyrata, Trichostrongylus axei, T. Oesophagostomum spp.; threadworm, colubriformis, Cooperia oncophora, C. Strongyloides ransomi (adults only)); so- punctata, C. pectinata, Oesophagostomum matic roundworm larvae (threadworm, radiatum, Nematodirus helvetianus S. ransomi (somatic larvae)); lungworms (adults only), N. spathiger (adults only), (Metastrongylus spp. (adults only)); lice Bunostomum phlebotomum; lungworms (H. suis); and mites (S. scabiei var. suis). (adults and fourth-stage larvae) (iii) Do not treat swine Limitations. (Dictyocaulus viviparus); liver flukes within 18 days of slaughter. (adults only) (Fasciola hepatica); grubs μ (4) American bison—(i) Amount. 200 g/ (parasitic stages) (Hypoderma bovis, H. kg of body weight by subcutaneous in- lineatum); lice (Linognathus vituli, jection. Haematopinus eurysternus, Solenopotes (ii) Indications for use. For the treat- capillatus); mites (Psoroptes ovis (syn. P. ment and control of grubs (H. bovis). communis var. bovis), Sarcoptes scabiei (iii) Limitations. Do not slaughter var. bovis); and for control of infections within 56 days of last treatment. of D. viviparus and O. radiatum for 28 (5) Reindeer—(i) Amount. 200 μg/kg of days afer treatment; O. ostertagi, T. body weight by subcutaneous injection. axei, and C. punctata for 21 days after (ii) Indications for use. For the treat- treatment; and H. placei and C. ment and control of warbles oncophora for 14 days after treatment. (Oedemagena tarandi). (3) Limitations. (i) Nos. 000010 and (iii) Limitations. Do not treat reindeer 061133: Do not treat cattle within 21 within 56 days of slaughter. days of slaughter. Nos. 055529 and

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058005: Do not treat cattle within 49 nostic or minor, brief surgical proce- days of slaughter. dures that do not require skeletal mus- (ii) Because a withdrawal time in cle relaxation. milk has not been established, do not (2) Subhuman primates—(i) Amount. 3 use in female dairy cattle of breeding to 15 mg/kilogram body weight age. A withdrawal period has not been intramuscularly, depending upon the established for this product in species, general condition, and age of preruminating calves. Do not use in the subject. calves to be processed for veal. (ii) Indications for use. For restraint. [55 FR 38984, Sept. 24, 1990, as amended at 62 [67 FR 17283, Apr. 10, 2002, as amended at 73 FR 14302, Mar. 26, 1997; 62 FR 63271, Nov. 28, FR 8192, Feb. 13, 2008. Redesignated at 79 FR 1997; 64 FR 26671, May 17, 1999; 69 FR 31735, 16191, Mar. 25, 2014, as amended at 80 FR June 7, 2004; 72 FR 27734, May 17, 2007; 77 FR 13229, Mar. 13, 2015; 83 FR 48946, Sept. 28, 2018] 64717, Oct. 23, 2012; 79 FR 64116, Oct. 28, 2014; 84 FR 39184, Aug. 9, 2019] § 522.1223 Ketamine, promazine, and EDITORIAL NOTE: At 81 FR 22524, Apr. 18, aminopentamide. 2016, § 522.1193 was amended; however, the (a) Specifications. Each milliliter of amendment could not be incorporated due to solution contains ketamine hydro- inaccurate amendatory instruction. chloride equivalent to 100 milligrams § 522.1204 Kanamycin. (mg) ketamine base activity, 7.5 (mg) of promazine hydrochloride, and 0.0625 (a) Specifications. Each milliliter of mg of aminopentamide hydrogen sul- solution contains 50 or 200 milligrams fate. (mg) of kanamycin as kanamycin sul- (b) Sponsor. See No. 054771 in fate. § 510.600(c) of this chapter. (b) Sponsor. See No. 054771 in (c) Conditions of use in cats—(1) § 510.600(c) of this chapter. Amount. Administer by intramuscular (c) Conditions of use in dogs and cats— injection 15 to 20 mg ketamine base per (1) Amount. Administer by subcuta- pound of body weight, depending on the neous or intramuscular injection 5 mg effect desired. per pound of body weight per day in (2) Indications for use. It is used in equally divided doses at 12-hour inter- cats as the sole anesthetic agent for vals. ovariohysterectomy and general sur- (2) Indications for use. For the treat- gery. ment of bacterial infections due to (3) Limitations. Federal law restricts kanamycin sensitive organisms in dogs this drug to use by or on the order of a and cats. licensed veterinarian. (3) Limitations. Federal law restricts this drug to use by or on the order of a [79 FR 16191, Mar. 25, 2014] licensed veterinarian. § 522.1225 Ketoprofen. [79 FR 16190, Mar. 25, 2014] (a) Specifications. Each milliliter of § 522.1222 Ketamine. solution contains 100 milligrams (mg) of ketoprofen. (a) Specifications. Each milliliter con- (b) Sponsor. See No. 054771 in tains ketamine hydrochloride equiva- § 510.600(c) of this chapter. lent to 100 milligrams (mg) ketamine (c) Conditions of use in horses—(1) base activity. Amount. Administer by intravenous in- (b) Sponsors. See Nos. 000859, 026637, jection 1.0 mg per pound of body weight 054771, 059399, 063286, and 069043 in once daily for up to 5 days. § 510.600(c) of this chapter. (2) Indications for use. For alleviation (c) Special considerations. Federal law of inflammation and pain associated restricts this drug to use by or on the with musculoskeletal disorders in order of a licensed veterinarian. horses. (d) Conditions of use—(1) Cats—(i) (3) Limitations. Do not use in horses Amount. 5 to 15 mg/pound body weight intended for human consumption. Fed- intramuscularly, depending on the ef- eral law restricts this drug to use by or fect desired. on the order of a licensed veterinarian. (ii) Indications for use. For restraint or as the sole anesthetic agent in diag- [79 FR 16191, Mar. 25, 2014]

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§ 522.1242 Levamisole. § 522.1260 Lincomycin. (a) Specifications. Each milliliter of (a) Specifications. Each milliliter of solution contains levamisole phosphate solution contains lincomycin hydro- equivalent to 136.5 or 182 milligrams of chloride monohydrate equivalent to: levamisole hydrochloride (13.65 or 18.2 (1) 25, 50, 100, or 300 milligrams (mg) percent). lincomycin. (b) Sponsor. See Nos. 000061 and 016592 (2) 25, 100, or 300 mg lincomycin. in § 510.600 of this chapter for use of (3) 300 mg lincomycin. 13.65 percent injection, and see No. (4) 100 or 300 mg lincomycin. 054771 for use of 13.65 and 18.2 percent (b) Sponsors. See sponsors in injection. § 510.600(c) of this chapter for uses as in (c) Related tolerances. See § 556.350 of paragraph (e) of this section. this chapter. (1) No. 054771 for use of concentra- (d) Conditions of use—(1) Amount. 2 tions in paragraph (a)(1) of this section milliliters per 100 pounds of body as in paragraph (e) of this section. weight, subcutaneously in the neck. (2) Nos. 016592 and 058005 for use of (2) Indications for use. (i) The 13.65 concentrations in paragraph (a)(2) of percent injection is used as an anthel- this section as in paragraph (e)(2) of mintic in cattle for treatment of the this section. following parasites: stomach worms (3) No. 054771 for use of concentration (Haemonchus, Trichostrongylus, in paragraph (a)(3) of this section as in Ostertagia), intestinal worms paragraph (e)(2) of this section. (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, (4) No. 061133 for use of concentra- Oesophagostomum, Chabertia), and tions in paragraph (a)(4) of this section lungworms (Dictyocaulus). as in paragraph (e)(2) of this section. (ii) The 18.2 percent injection is used (c) Special considerations. When com- as an anthelmintic in cattle for treat- mon labeling for use of the drug in ment of the following parasites: stom- dogs, cats, and swine is included with ach worms (Haemonchus, the drug, all such uses are subject to Trichostrongylus, Ostertagia), intestinal the labeling requirements of § 201.105 of worms (Trichostrongylus, Cooperia, this chapter. Nematodirus, Bunostomum, (d) Related tolerances. See § 556.360 of Oesophagostomum) and lungworms this chapter. (Dictyocaulus). (e) Conditions of use. It is used for ani- (3) Limitations. Do not administer mals as follows: more than 10 milliliters per site. Cattle (1) Dogs and cats—(i) Amount. 5 mg that are severely parasitized or main- per pound (/lb) of body weight twice tained under conditions of constant daily or 10 mg/lb body weight once helminth exposure may require re- daily by intramuscular injection; 5 to treatment within 2 to 4 weeks after 10 mg/lb body weight one or two times first treatment. Consult your veteri- daily by slow intravenous injection. narian for assistance in the diagnosis, (ii) Indications for use. Infections treatment, and control of parasitism. caused by Gram-positive organisms, Consult your veterinarian before using particularly streptococci and in severely debilitated animals or ani- staphylococci. mals under severe stress. Do not ad- (iii) Limitations. Federal law restricts minister to cattle within 7 days of this drug to use by or on the order of a slaughter. Do not administer to dairy licensed veterinarian. animals of breeding age. (2) Swine—(i) Amount. 5 mg/lb body [43 FR 20489, May 12, 1978, as amended at 43 weight once daily by intramuscular in- FR 29289, July 7, 1978; 43 FR 60895, Dec. 29, jection for 3 to 7 days. 1978; 47 FR 10807, Mar. 12, 1982; 62 FR 61625, (ii) Indications for use. Treatment of Nov. 19, 1997; 65 FR 61090, Oct. 16, 2000; 67 FR infectious arthritis and mycoplasma 63055, Oct. 10, 2002. Redesignated and amend- pneumonia. ed at 79 FR 16191, Mar. 25, 2014; 83 FR 48946, Sept. 28, 2018; 84 FR 32992, July 11, 2019]

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(iii) Limitations. Do not treat within horses intended for human consump- 48 hours of slaughter. tion. [40 FR 13858, Mar. 27, 1975, as amended at 50 [55 FR 1185, Jan. 12, 1990, as amended at 56 FR 31351, Aug. 2, 1985; 67 FR 34388, May 14, FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 2002; 68 FR 51705, Aug. 28, 2003; 69 FR 11507, 1995; 61 FR 66582, Dec. 18, 1996; 74 FR 25146, Mar. 11, 2004; 69 FR 47361, Aug. 5, 2004; 71 FR May 27, 2009] 51996, Sept. 1, 2006; 78 FR 17597, Mar. 22, 2013; 79 FR 16191, Mar. 25, 2014; 81 FR 59134, Aug. § 522.1315 Maropitant. 29, 2016; 84 FR 8974, Mar. 13, 2019] (a) Specifications. Each milliliter of § 522.1289 Lufenuron. solution contains 10 milligrams (mg) maropitant as maropitant citrate. (a) Specifications. Each milliliter of (b) Sponsor. See No. 054771 in suspension contains 100 milligrams § 510.600(c) of this chapter. (mg) of lufenuron. (b) Sponsor. See No. 058198 in (c) Conditions of use—(1) Dogs—(i) § 510.600(c) of this chapter. Amount. Administer 1.0 mg per kilo- (c) Conditions of use in cats—(1) gram (mg/kg) of body weight by sub- Amount. 10 mg per kilogram (4.5 mg per cutaneous or intravenous injection pound) of body weight every 6 months, once daily for up to 5 consecutive days. by subcutaneous injection. (ii) Indications for use. For the pre- (2) Indications for use. For control of vention and treatment of acute vom- flea populations in cats 6 weeks of age iting. and older. (iii) Limitations. Federal law restricts (3) Limitations. Federal law restricts this drug to use by or on the order of a this drug to use by or on the order of a licensed veterinarian. licensed veterinarian. (2) Cats—(i) Amount. Administer 1.0 mg/kg of body weight by subcutaneous [79 FR 16191, Mar. 25, 2014, as amended at 80 or intravenous injection once daily for FR 61297, Oct. 13, 2015] up to 5 consecutive days. § 522.1290 Luprostiol. (ii) Indications for use. For the treatment of vomiting. (a) Specifications. Each milliliter of (iii) Limitations. Federal law restricts solution contains 7.5 milligrams (mg) this drug to use by or on the order of a luprostiol. licensed veterinarian. (b) Sponsor. See No. 051311 in § 510.600(c) of this chapter. [72 FR 9243, Mar. 1, 2007, as amended at 77 FR (c) Special considerations. Labeling 39391, July 3, 2012; 79 FR 16191, Mar. 25, 2014; shall bear the following statements: 81 FR 22524, Apr. 18, 2016] Warning: Women of childbearing age, asthmatics, and persons with bronchial § 522.1335 Medetomidine. and other respiratory problems should (a) Specifications. Each milliliter of exercise extreme caution when han- solution contains 1.0 milligrams of dling this product. In the early stages, medetomidine hydrochloride. women may be unaware of their preg- (b) Sponsor. See Nos. 015914 and 052483 nancies. Luprostiol is readily absorbed in § 510.600(c) of 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, (2) Indications for use. For estrus clinical procedures, minor surgical pro- control and termination of pregnancy cedures not requiring muscle relax- in mares. ation, and minor dental procedures not (3) Limitations. Federal law restricts requiring intubation. The intravenous this drug to use by or on the order of a route of administration is more effica- licensed veterinarian. Do not use in cious for dental care.

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(3) Limitations. Federal law restricts (b) Sponsors. See Nos. 000010, 016729, this drug to use by or on the order of a 026637, and 055529 in § 510.600(c) of this licensed veterinarian. chapter. [61 FR 21075, May 9, 1996, as amended at 79 (c) Conditions of use—(1) Dogs—(i) FR 16191, Mar. 25, 2014; 82 FR 58556, Dec. 13, Amount. Administer 0.09 mg per pound 2017] (mg/lb) body weight (0.2 mg per kilogram (mg/kg)) by intravenous or sub- § 522.1350 Melatonin implant. cutaneous injection on the first day of (a) Specifications. The drug is a sili- treatment. For treatment after day 1, cone rubber elastomer implant con- administer meloxicam suspension oral- taining 2.7 milligrams of melatonin. ly at 0.045 mg/lb (0.1 mg/kg) body (b) Sponsor. See No. 053923 in weight once daily as in § 520.1367(c) of § 510.600(c) of this chapter. this chapter. (c) Conditions of use—(1) Amount. One (ii) Indications for use. For the control implant per mink. of pain and inflammation associated (2) Indications for use. For use in with osteoarthritis. healthy male and female kit and adult (iii) Limitations. Federal law restricts female mink (Mustela vison) to accel- this drug to use by or on the order of a erate the fur priming cycle. licensed veterinarian. (3) Limitations. For subcutaneous im- (2) Cats—(i) Amount. Administer 0.14 plantation in mink only. Do not im- mg/lb (0.3 mg/kg) body weight as a sin- plant potential breeding stock. Do not gle, one-time subcutaneous injection. use in food-producing animals. (ii) Indications for use. For the control [59 FR 37422, July 22, 1994] of postoperative pain and inflammation associated with orthopedic sur- § 522.1362 Melarsomine powder for in- gery, ovariohysterectomy, and castra- jection. tion when administered prior to sur- (a) Specifications. The drug consists of gery. a vial of lyophilized powder containing (iii) Limitations. Federal law restricts 50 milligrams of melarsomine this drug to use by or on the order of a dihydrochloride which is reconstituted licensed veterinarian. with the provided 2 milliliters of sterile water for injection. [68 FR 68724, Dec. 10, 2003, as amended at 69 (b) Sponsor. See Nos. 000010 and 086073 FR 69523, Nov. 30, 2004; 78 FR 5715, Jan. 28, in § 510.600(c) of this chapter. 2013; 79 FR 74020, Dec. 15, 2014; 85 FR 18119, Apr. 1, 2020] (c) Conditions of use—(1) Amount. Ad- minister only by deep intramuscular § 522.1372 Mepivacaine. injection in the lumbar muscles (L3– (a) Specifications. Each milliliter L5). (2) Indications. Treatment of sta- (mL) of solution contains 20 milligrams bilized, class 1, 2, and 3 heartworm dis- mepivacaine hydrochloride. ease (asymptomatic to mild, moderate, (b) Sponsor. See No. 054771 in and severe, respectively) caused by im- § 510.600(c) of this chapter. mature (4 month-old, stage L5) to ma- (c) Conditions of use in horses—(1) ture adult infections of Dirofilaria Amount. For nerve block, 3 to 5 mL; for immitis in dogs. epidural anesthesia, 5 to 20 mL; for (3) Limitations. Federal law restricts intra-articular anesthesia, 10 to 15 mL; this drug to use by or on the order of a for infiltration, as required; for anes- licensed veterinarian. thesia of the laryngeal mucosa prior to [60 FR 49340, Sept. 25, 1995, as amended at 79 ventriculectomy, by topical spray, 25 FR 16191, Mar. 25, 2014; 82 FR 21690, May 10, to 40 mL, by infiltration, 20 to 50 mL. 2017; 84 FR 39184, Aug. 9, 2019] (2) Indications for use. For use as a local anesthetic for infiltration, nerve § 522.1367 Meloxicam. block, intra-articular and epidural an- (a) Specifications. Each milliliter of esthesia, and topical and/or infiltration solution contains 5.0 milligrams (mg) anesthesia of the laryngeal mucosa meloxicam. prior to ventriculectomy.

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(3) Limitations. Not for use in horses disorders; and as supportive therapy to intended for human consumption. Fed- antibacterial treatment of severe infec- eral law restricts this drug to use by or tions. on the order of a licensed veterinarian. (iii) Limitations. Federal law restricts this drug to use by or on the order of a [71 FR 39547, July 13, 2006, as amended at 79 FR 16191, Mar. 25, 2014] licensed veterinarian. (2) Cats—(i) Amount. Administer 10 to § 522.1380 Methocarbamol. 20 mg by intramuscular injection. (ii) Indications for use. For treatment (a) Specifications. Each milliliter of of inflammation and related disorders; solution contains 100 milligrams (mg) treatment of allergic and dermatologic of methocarbamol. disorders; and as supportive therapy to (b) Sponsor. See No. 051031 in antibacterial treatment of severe infec- § 510.600(c) of this chapter. tions. (c) Conditions of use—(1) Amount—(i) (iii) Limitations. Federal law restricts Dogs and cats. Administer by intra- this drug to use by or on the order of a venous injection 20 mg per pound of licensed veterinarian. body weight for moderate conditions or (3) Horses—(i) Amount. Administer 200 25 to 100 mg per pound of body weight mg by intramuscular injection or 40 to for severe conditions (tetanus and 240 mg by intrasynovial injection. strychnine poisoning). The total cumu- (ii) Indications for use. For treatment lative dose should not to exceed 150 mg of inflammation and related disorders. per pound of body weight. (iii) Limitations. Do not use in horses (ii) Horses. Administer by intra- intended for human consumption. Fed- venous injection 2 to 10 mg per pound eral law restricts this drug to use by or of body weight for moderate conditions on the order of a licensed veterinarian. or 10 to 25 mg per pound of body weight for severe conditions (tetanus). Addi- [43 FR 59058, Dec. 19, 1978, as amended at 51 tional amounts may be needed to re- FR 741, Jan. 8, 1986; 53 FR 40728, Oct. 18, 1988; lieve residual effects and to prevent re- 62 FR 35076, June 30, 1997; 76 FR 53051, Aug. 25, 2011; 78 FR 21060, Apr. 9, 2013; 79 FR 16191, currence of symptoms. Mar. 25, 2014; 83 FR 48946, Sept. 28, 2018] (2) Indications for use. As an adjunct for treating acute inflammatory and § 522.1450 Moxidectin solution. traumatic conditions of the skeletal (a) Specifications. Each milliliter of muscles and to reduce muscular solution contains 10 milligrams (mg) spasms. moxidectin. (3) Limitations. Do not use in horses (b) Sponsor. See No. 000859 in intended for human consumption. Fed- § 510.600(c) of this chapter. eral law restricts this drug to use by or (c) Related tolerances. See § 556.426 of on the order of a licensed veterinarian. this chapter. [79 FR 16191, Mar. 25, 2014, as amended at 82 (d) Special considerations. See § 500.25 FR 11508, Feb. 24, 2017] of this chapter. (e) Conditions of use in beef and non- § 522.1410 Methylprednisolone. lactating dairy cattle—(1) Amount. Ad- (a) Specifications. Each milliliter of minister 0.2 mg/kg of body weight (0.2 suspension contains 20 or 40 milligrams mg/2.2 pound) as a single, subcutaneous (mg) of methylprednisolone acetate. injection. (b) Sponsors. See Nos. 054771 and (2) Indications for use. For treatment 069043 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

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(adults), Cooperia surnabada (adults and a single subcutaneous injection to pro- fourth-stage larvae), Nematodirus vide 0.5 mg/kg body weight (0.23 mg/lb). helvetianus (adults), Oesophagostomum (2) Indications for use—(i) Suspension radiatum (adults and fourth-stage lar- described in paragraph (a)(1) of this sec- vae), Trichuris spp. (adults); tion. For prevention of heartworm dis- lungworms: Dictyocaulus viviparus ease caused by Dirofilaria immitis in (adults and fourth-stage larvae); grubs: dogs 6 months of age and older; and for Hypoderma bovis and Hypoderma treatment of existing larval and adult lineatum; mites: Psoroptes ovis hookworm (Ancylostoma caninum and (Psoroptes communis var. bovis); lice: Uncinaria stenocephala) infections. Linognathus vituli and Solenopotes (ii) Suspension described in paragraph capillatus; for protection of cattle from (a)(2) of this section. For prevention of reinfection with D. viviparus and O. heartworm disease caused by Dirofilaria radiatum for 42 days after treatment, immitis for 12 months in dogs 12 months with H. placei for 35 days after treat- of age and older; and for treatment of ment, and with O. ostertagi and T. axei existing larval and adult hookworm for 14 days after treatment. (Ancylostoma caninum and Uncinaria (3) Limitations. Do not slaughter cat- stenocephala) infections. tle within 21 days of treatment. Be- (3) Limitations. Federal law restricts 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 [85 FR 4208, Jan. 24, 2020] older. A withdrawal period has not been established for pre-ruminating § 522.1452 Nalorphine. calves. Do not use in calves to be proc- (a) Specifications. Each milliliter of essed for veal. solution contains 5 milligrams of nalorphine hydrochloride. [70 FR 36337, June 23, 2005, as amended at 71 FR 7414, Feb. 13, 2006; 76 FR 48714, Aug. 9, (b) Sponsor. See No. 000010 in 2011; 82 FR 21690, May 10, 2017] § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) § 522.1451 Moxidectin microspheres Amount. One milligram per 5 pounds; for injection. intravenously, intramuscularly, or subcutaneously. (a) Specifications. The drug product (2) Indications for use. Respiratory consists of two separate vials. One vial and circulatory depression in dogs re- contains 10 percent moxidectin micro- sulting from overdosage of, or unusual spheres and the second vial contains a sensitivity to, morphine and certain vehicle for constitution of the other narcotics. Not for depression due moxidectin microspheres. to any other cause. (1) Each milliliter (mL) of con- (3) Limitations. Federal law restricts stituted suspension contains 3.4 milli- this drug to use by or on the order of a grams (mg) moxidectin. licensed veterinarian. (2) Each mL of constituted suspension contains 10 mg moxidectin. [44 FR 6707, Feb. 2, 1979, as amended at 47 FR 36418, Aug. 20, 1982; 62 FR 63271, Nov. 28, 1997; (b) Sponsor. See No. 54771 in 79 FR 16191, Mar. 25, 2014; 84 FR 39184, Aug. 9, § 510.600(c) of this chapter. 2019] (c) Conditions of use in dogs—(1) Amount. (i) Using the suspension de- § 522.1465 Naltrexone. scribed in paragraph (a)(1) of this sec- (a) Specifications. Each milliliter of tion, administer 0.05 mL of the con- solution contains 50 milligrams of stituted suspension per kilogram (kg) naltrexone hydrochloride. of body weight (0.023 mL per pound (lb)) (b) Sponsor. See 053923 in § 510.600(c) of as a single subcutaneous injection to this chapter. provide 0.17 mg/kg body weight (0.0773 (c) Conditions of use in elk and moose— mg/lb). (1) Amount. 100 milligrams of (ii) Using the suspension described in naltrexone hydrochloride for each mil- paragraph (a)(2) of this section, admin- ligram of carfentanil citrate adminis- ister 0.05 mL of the constituted suspen- tered. One-quarter of the dose should sion/kg of body weight (0.023 mL/lb) as be administered intravenously and

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three-quarters of the dose should be ad- fections due to organisms susceptible ministered subcutaneously. to neomycin. (2) Indications for use. As an antago- (3) Limitations. Not for parenteral use nist to carfentanil citrate immobiliza- in food-producing animals because of tion in free-ranging or confined elk and prolonged residues in edible tissues. moose (Cervidae). Federal law restricts this drug to use (3) Limitations. Do not use in domes- by or on the order of a licensed veteri- tic food-producing animals. Do not use narian. in free-ranging animals for 45 days before or during hunting season. Federal [79 FR 16192, Mar. 25, 2014] law restricts this drug to use by or on the order of a licensed veterinarian. § 522.1503 Neostigmine. [62 FR 5320, Feb. 5, 1997, as amended at 79 FR (a) Specifications. Each milliliter of 16191, Mar. 25, 2014] solution contains 2 milligrams (mg) neostigmine methylsulfate. § 522.1468 Naproxen for injection. (b) Sponsor. See No. 000061 in (a) Specifications. The drug is a § 510.600(c) of this chapter. lyophilized powder which is reconsti- (c) Conditions of use—(1) Amount. Ad- tuted with sterile water for injection minister to cattle and horses at a dos- to form a 10 percent sterile aqueous so- age level of 1 mg per (/) 100 pounds (lbs) lution (100 milligrams per milliliter). of body weight subcutaneously. Admin- (b) Sponsor. See 054771 in § 510.600(c) of ister to sheep at a dosage level of 1 to this chapter. 11⁄2 mg/100 lbs body weight (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 licensed veterinarian. [40 FR 13858, Mar. 27, 1975, as amended at 62 FR 61625, Nov. 19, 1997; 79 FR 16192, Mar. 25, [46 FR 26763, May 15, 1981. Redesignated and 2014] amended at 51 FR 24525, July 7, 1986; 61 FR 5507, Feb. 13, 1996; 79 FR 16192, Mar. 25, 2014] § 522.1610 Oleate sodium. § 522.1484 Neomycin. (a) Specifications. Each milliliter of (a) Specifications. Each milliliter of solution contains 50 milligrams (mg) of solution contains 50 milligrams (mg) of sodium oleate. neomycin sulfate (equivalent to 35 mg (b) Sponsor. See No. 037990 in of neomycin base). § 510.600(c) of this chapter. (b) Sponsor. See No. 054771 in (c) Conditions of use in horses—(1) § 510.600(c) of this chapter. Amount. Administer by parenteral in- (c) Conditions of use in dogs and cats— jection depending on the area of re- (1) Amount. Administer 5 mg per pound sponse desired. An injection of 1 milli- of body weight daily by intramuscular liter (mL) will produce a response of or intravenous injection, divided into approximately 15 square centimeters. portions administered every 6 to 8 Do not inject more than 2 mL per in- hours for 3 to 5 days. jection site. Regardless of the number (2) Indications for use. For the treat- of injection sites, the total volume ment of acute and chronic bacterial in- used should not exceed 10 mL.

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(2) Indications for use. It is used in (iii) Limitations. Federal law restricts horses to stimulate infiltration of cel- this drug to use by or on the order of a lular blood components that subse- licensed veterinarian. quently differentiate into fibrous and/ [40 FR 13858, Mar. 27, 1975, as amended at 41 or fibrocartilagenous tissue. FR 32583, Aug. 4, 1976; 79 FR 16192, Mar. 25, (3) Limitations. Do not use in horses 2014] intended for human consumption. Fed- eral law restricts this drug to use by or § 522.1660 Oxytetracycline injectable on the order of a licensed veterinarian. dosage forms. [41 FR 27034, July 1, 1976, as amended at 50 § 522.1660a Oxytetracycline solution, FR 40966, Oct. 8, 1985; 79 FR 16192, Mar. 25, 200 milligrams/milliliter. 2014] (a) Specifications. Each milliliter of § 522.1620 Orgotein for injection. sterile solution contains 200 milligrams of oxytetracycline base. (a) Specifications. Orgotein for injec- (b) Sponsors. See Nos. 000010, 016592, tion is packaged in a vial containing 5 048164, 054771, 055529, and 061133 in milligrams of orgotein and 10 milli- § 510.600(c) of this chapter. grams of sucrose as lyophilized sterile (c) Related tolerances. See § 556.500 of nonpyrogenic powder with directions this chapter. for dissolving the contents of the vial (d) Special considerations. When la- in 2 milliliters of diluent which is so- beled for the treatment of dium chloride injection, U.S.P. anaplasmosis or anthrax, labeling shall (b) Sponsor. See No. 024991 in also bear the following: ‘‘Federal law § 510.600(c) of this chapter. restricts this drug to use by or on the (c) Conditions of use—(1) Horses—(i) order of a licensed veterinarian.’’ Amount. Administer by deep (e) Conditions of use—(1) Beef cattle, intramuscular injection at a dosage dairy cattle, and calves including level of 5 milligrams (mg) every other prerumenative (veal) calves—(i) Amounts day for 2 weeks and twice weekly for 2 and indications for use—(A) 3 to 5 mg to 3 more weeks. Severe cases, both per pound of body weight (mg/lb BW) acute and chronic, may benefit more per day (/day) intramuscularly, from daily therapy initially. Dosage subcutaneously, or intravenously for may be continued beyond 5 weeks if treatment of pneumonia and shipping satisfactory improvement has not been fever complex associated with achieved. Pasteurella spp. and Haemophilus spp., (ii) Indications for use. It is used in foot-rot and diphtheria caused by the treatment of soft tissue inflamma- Fusobacterium necrophorum, bacterial tion associated with the musculo- enteritis (scours) caused by Escherichia coli, wooden tongue caused by skeletal system. Actinobacillus lignieresii, leptospirosis (iii) Limitations. Do not use in horses caused by Leptospira pomona, wound in- intended for human consumption. Fed- fections and acute metritis caused by eral law restricts this drug to use by or Staphylococcus spp. and Streptococcus on the order of a licensed veterinarian. spp., and anthrax caused by Bacillus (2) Dogs—(i) Amount. Administer by anthracis. subcutaneous injection 5 mg daily for 6 (B) 5 mg/lb BW/day intramuscularly days, and thereafter, every other day or intravenously for treatment of for 8 days. In less severe conditions, anaplasmosis caused by Anaplasma shorter courses of therapy may be indi- marginale, severe foot-rot, and ad- cated. vanced cases of other indicated dis- (ii) Indications for use. It is used for eases. the relief of inflammation associated (C) 9 mg/lb BW intramuscularly or with ankylosing spondylitis, subcutaneously as single dosage where spondylosis, and disc disease. When se- retreatment of calves and yearlings for vere nerve damage is present, response bacterial pneumonia is impractical, for will occur much more slowly, if at all. treatment of infectious bovine keratoconjunctivitis (pinkeye) caused

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by Moraxella bovis, or where retreat- (d) Special considerations. When la- ment for anaplasmosis is impractical. beled for use as in paragraph (e)(1)(i)(D) (ii) Limitations. Exceeding the highest or (e)(1)(i)(E) of this section, labeling recommended level of drug per pound shall also bear the following: ‘‘Federal of bodyweight per day, administering law restricts this drug to use by or on more than the recommended number of the order of a licensed veterinarian.’’. treatments, and/or exceeding 10 mL (e) Conditions of use—(1) Beef cattle, intramuscularly or subcutaneously per nonlactating dairy cattle, and calves in- injection site in adult beef and dairy cluding preruminating (veal) calves—(i) cattle may result in antibiotic residues Amounts and indications for use—(A) 3 to beyond the withdrawal time. Rapid in- 5 mg per pound of bodyweight (mg/lb travenous administration in cattle BW) per day (/day) intramuscularly, may result in animal collapse. Oxytet- subcutaneously, or intravenously for racycline should be administered intra- treatment of pneumonia and shipping venously slowly over a period of at fever complex associated with least 5 minutes. Discontinue treatment Pasteurella spp. and Histophilus spp., at least 28 days prior to slaughter. foot-rot and diphtheria caused by Milk taken from animals during treat- Fusobacterium necrophorum, bacterial ment and for 96 hours after the last enteritis (scours) caused by Escherichia treatment must not be used for food. coli, wooden tongue caused by (2) Swine—(i) Amounts and indications Actinobacillus lignieresii, leptospirosis for use. (A) Sows: 3 mg/lb BW caused by Leptospira pomona, wound in- intramuscularly once, approximately 8 fections and acute metritis caused by hours before farrowing or immediately Staphylococcus spp. and Streptococcus after completion of farrowing, as an aid spp. in control of infectious enteritis (baby (B) 5 mg/lb BW/day intramuscularly, pig scours, colibacillosis) in suckling subcutaneously, or intravenously for pigs caused by E. coli. treatment of severe foot-rot, and ad- (B) 3 to 5 mg/lb BW/day vanced cases of other indicated dis- intramuscularly for treatment of bac- eases. terial enteritis (scours, colibacillosis) (C) 9 mg/lb BW intramuscularly or caused by E. coli, pneumonia caused by subcutaneously as single dosage where Pasteurella multocida, and leptospirosis retreatment of calves and yearlings for caused by Leptospira pomona. bacterial pneumonia is impractical or (C) 9 mg/lb BW as a single dosage for treatment of infectious bovine where retreatment for pneumonia is keratoconjunctivitis (pinkeye) caused impractical. by Moraxella bovis. (ii) Limitations. Administer (D) 9 to 13.6 mg/lb BW intramuscularly. Do not inject more intramuscularly or subcutaneously as than 5 mL per site in adult swine. Dis- single dosage where retreatment of continue treatment at least 28 days calves and yearlings for bacterial pneu- prior to slaughter. monia is impractical or for treatment [45 FR 16479, Mar. 14, 1980. Redesignated and of infectious bovine amended at 69 FR 31879, June 8, 2004] keratoconjunctivitis (pinkeye) caused by Moraxella bovis. EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 522.1660a, see the List of (E) 13.6 mg/lb BW intramuscularly or 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.govinfo.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

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the highest recommended level of drug/ hydrochloride in each milliliter of ster- lb BW/day, administering more than ile solution. the recommended number of treat- (2) Sponsor. See No. 069043 in ments, and/or exceeding 10 mL § 510.600(c) of this chapter. intramuscularly or subcutaneously per (3) Conditions of use. (i) The drug is injection site may result in antibiotic intended for use in beef cattle, beef residues beyond the withdrawal time. calves, nonlactating dairy cattle, and Rapid intravenous administration may dairy calves for treatment of disease result in animal collapse. Oxytetra- conditions caused by one or more of cycline should be administered intra- the following oxytetracycline sensitive venously slowly over a period of at pathogens listed as follows: pneumonia least 5 minutes. Discontinue treatment and shipping fever complex (Pasteurella at least 28 days prior to slaughter. Not spp.; Hemophilis spp.; Klebsiella spp. ), for use in lactating dairy animals. bacterial enteritis (scours) (E. coli), (2) Swine—(i) Amounts and indications foot-rot (Spherophorus necrophorus), for use—(A) Sows: 3 mg/lb BW diphtheria (Spherophorus necrophorus), intramuscularly once, approximately 8 wooden tongue (Actinobacillus hours before farrowing or immediately lignieresi), leptospirosis (Leptospira po- after completion of farrowing, as an aid mona), and wound infections; acute me- in control of infectious enteritis (baby tritis; traumatic injury (caused by a pig scours, colibacillosis) in suckling variety of bacterial organisms (such as pigs caused by E. coli. streptococcal and staphylococcal orga- (B) 3 to 5 mg/lb BW/day nisms).) intramuscularly for treatment of bac- (ii) It is administered by terial enteritis (scours, colibacillosis) intramuscular injection of 3 to 5 milli- caused by pneumonia caused by E. coli, grams of oxytetracycline hydro- Pasteurella multocida, and leptospirosis chloride per pound of body weight per caused by Leptospira pomona. day. Leptospirosis, severe foot-rot and (C) 9 mg/lb BW as a single dosage severe forms of the indicated diseases where retreatment for pneumonia is should be treated with 5 milligrams per impractical. pound of body weight per day. Treat- (ii) Administer Limitations. ment should be continued for 24 to 48 intramuscularly. Treatment should be hours following remission of disease continued 24 to 48 hours beyond remis- symptoms; however, not to exceed a sion of disease signs, however, not to total of 4 consecutive days. Only 2 mil- exceed a total of 4 consecutive days. liliters of the drug should be injected Exceeding the highest recommended per site in case of calves weighing 100 level of drug/lb BW/day, administering pounds or less and not more than 10 more than the recommended number of milliliters should be injected per site treatments, and/or exceeding 5 mL in adult cattle. intramuscularly per injection site may (iii) Discontinue treatment with the result in antibiotic residues beyond the drug at least 20 days prior to slaughter withdrawal time. Discontinue treat- of the animal. When administered to ment at least 28 days prior to slaugh- animals within 30 days of slaughter, ter. muscle discoloration may necessitate [68 FR 54805, Sept. 19, 2003. Redesignated and trimming of injection site and sur- amended at 69 FR 31879, June 8, 2004; 73 FR rounding tissues. 14926, Mar. 20, 2008] (iv) For use only in beef cattle, beef calves, nonlactating dairy cattle, and § 522.1662 Oxytetracycline hydrochloride implantation or injectable dairy calves. dosage forms. (c)(1) Specifications. Each milliliter of sterile solution contains 50 or 100 milli- § 522.1662a Oxytetracycline hydro- grams of oxytetracycline (as oxytetra- chloride injection. cycline hydrochloride). (a) For related tolerances see § 556.500 (2) Sponsor. See 069043 in § 510.600(c) of of this chapter. this chapter. (b)(1) Specifications. The drug con- (3) Conditions of use—(i) Beef cattle tains 50 milligrams of oxytetracycline and nonlactating dairy cattle—(A)

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Amount. Three to 5 milligrams of oxy- (B) Indications for use. For treatment tetracycline per pound of body weight of bacterial enteritis (scours, per day; 5 milligrams per pound of body colibacillosis) caused by Escherichia weight per day for the treatment of coli, pneumonia caused by Pasteurella anaplasmosis, severe foot-rot, and se- multocida, and leptospirosis caused by vere cases of other indicated diseases. Leptospira pomona. Sows: as an aid in (B) Indications for use. Treatment of control of infectious enteritis (baby pig diseases due to oxytetracycline-suscep- scours, colibacillosis) in suckling pigs tible organisms as follows: Pneumonia caused by Escherichia coli. and shipping fever complex associated (C) Limitations. Administer with Pasteurella spp., Haemophilus spp., intramuscularly. Do not inject more and Klebsiella spp., foot-rot and diph- than 5 milliliters per site. Do not use theria caused by Spherophorus for more than 4 consecutive days. Dis- necrophorus, bacterial enteritis (scours) continue treatment at least 26 days be- caused by Escherichia coli, wooden fore slaughter. tongue caused by Actinobacillus (d)(1) Specifications. The drug con- lignieresi, leptospirosis caused by tains 50 or 100 milligrams of oxytetra- Leptospira pomona, and wound infec- cycline hydrochloride in each milliliter tions and acute metritis caused by of sterile solution. Staphylococcus spp. and Streptococcus (2) Sponsor. See No. 054771 in spp. If labeled for use by or on the § 510.600(c) of this chapter. order of a licensed veterinarian, it may (3) Conditions of use. (i) The drug is intended for use in the treatment of be used for the treatment of disease due to oxytetracycline-suscep- anaplasmosis caused by Anaplasma tible organisms in beef cattle and non- marginale. lactating dairy cattle. It is indicated in (C) Limitations. For 50-milligram-per- the treatment of pneumonia and ship- milliliter solution, administer ping fever complex associated with intramuscularly or intravenously; for Pasteurella spp., Haemophilus spp., 100-milligram-per-milliliter solution, Klebsiella spp., foot-rot and diphtheria administer intramuscularly only. caused by Spherophorus necrophorus, Treatment of all diseases should be in- bacterial enteritis (scours) caused by stituted early and continue for 24 to 48 Escherichia coli, wooden tongue caused hours beyond remission of disease by Actinobacillus lignieresi, acute metri- symptoms, but not to exceed a total of tis, and wound infections caused by 4 consecutive days. Consult your vet- staphylococcal and streptococcal orga- erinarian if no improvement is noted nisms. within 48 hours. Do not inject more (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

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not use more than 2 milliliters per in- sows as an aid in the control of infec- jection site. tious enteritis (baby pig scours, (iii) Not for use in lactating dairy colibacillosis) in suckling pigs caused cattle. Discontinue treatment at least by Escherichia coli. 19 days prior to slaughter. When ad- (B) Administer by intramuscular in- ministered intramuscularly within 30 jection at 3 to 5 milligrams of oxytet- days of slaughter, muscle discoloration racycline per pound of body weight per may necessitate trimming of the injec- day to swine. Administered to sows at tion site and surrounding tissues. 3 milligrams of oxytetracycline per (e)(1) Specifications. The drug con- pound of body weight approximately 8 tains 50 milligrams of oxytetracycline hours before farrowing or immediately hydrochloride in each milliliter of ster- after farrowing. ile solution. (iii) In poultry (broilers, turkeys, and (2) Sponsor. See No. 054771 in breeding chickens) as follows: § 510.600(c) of this chapter. (A) It is used for the treatment of air (3) Conditions of use. (i) In beef cattle sacculitis (air-sac disease, chronic res- and nonlactating dairy cattle as fol- piratory disease) caused by Mycoplasma lows: gallisepticum and Escherichia coli; fowl (A) It is used for the treatment of cholera caused by Pasteurella multocida; pneumonia and shipping fever complex infectious sinusitis caused by Myco- associated with Pasteurella spp. and plasma gallisepticum; and infectious syn- Haemophilus spp.; foot-rot and diph- ovitis caused by Mycoplasma synoviae. theria caused by Spherophorus (B) Administered subcutaneously to necrophorus; bacterial enteritis (scours) chickens 1 day to 2 weeks of age at 6.25 caused by Escherichia coli; wooden milligrams of oxytetracycline per bird tongue caused by Actinobacillus per day diluted with 1 part of the drug lignieresi; leptospirosis caused by to 3 parts of sterile water; to chickens Leptospira pomona; wound infections 2 to 4 weeks of age using the same di- and acute metritis caused by staphy- luted product at 12.5 milligrams of oxy- lococcal and streptococcal organisms. tetracycline per bird; to chickens 4 to 8 (B) Administer by intravenous or weeks of age without dilution at 25 intramuscular injection at 3 to 5 milli- milligrams of oxytetracycline per bird; grams of oxytetracycline per pound of to chickens 8 weeks of age (broilers and body weight per day. In the treatment light pullets) at 50 milligrams of oxy- of severe foot-rot and severe forms of tetracycline per bird; to adult chickens the indicated diseases, a dosage level of at 100 milligrams of oxytetracycline 5 milligrams per pound of body weight per bird. per day is recommended. (C) Administered subcutaneously to (C) If the labeling of the drug bears turkeys 1 day to 2 weeks of age and 2 to the statement ‘‘Federal law restricts 4 weeks of age at the same dosage as this drug to use by or on the order of a chickens; to turkeys 4 to 6 weeks of age licensed veterinarian,’’ it may include at 50 milligrams of oxytetracycline as additional directions for use in beef the undiluted product per bird; to tur- cattle and nonlactating dairy cattle for keys 6 to 9 weeks of age at 100 milli- the treatment of anaplasmosis caused grams of oxytetracycline per bird; to by Anaplasma marginale, and anthrax turkeys 9 to 12 weeks of age at 150 mil- caused by Bacillus anthracis in which ligrams of oxytetracycline per bird; to case the drug is given at 3 to 5 milli- turkeys 12 weeks of age and older at 200 grams of oxytetracycline per pound of milligrams of oxytetracycline per bird. body weight per day for anthrax, and at In light turkey breeds, no more than 25 5 milligrams per pound of body weight milligrams per pound of body weight is per day for anaplasmosis. administered. For the treatment of in- (ii) In swine as follows: fectious sinusitis in turkeys, 1⁄4 to 1⁄2 (A) It is used for the treatment of milliliter of the drug is injected di- bacterial enteritis (scours, rectly into each swollen sinus depend- colibacillosis) caused by Escherichia ing upon the age of the bird and the se- coli; pneumonia caused by Pasteurella verity of the condition. At the time multocida; and leptospirosis caused by that the sinuses are treated, the drug Leptospira pomona. Administered to should also be administered

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subcutaneously to the birds according coli, wooden tongue caused by to the dosage schedule given in this Actinobacillus lignieresii, leptospirosis paragraph (e)(3)(iii)(C). If refilling of caused by Leptospira pomona, and the sinuses occurs, the treatment may wound infections and acute metritis be repeated in 5 to 7 days. caused by Staphylococcus spp. and Strep- (iv) Treatment of all diseases should tococcus spp. If labeled for use by or on be instituted early. Treatment should the order of a licensed veterinarian, it continue for 24 to 48 hours beyond the may be used for the treatment of remission of disease symptoms, but not anaplasmosis caused by Anaplasma exceed a total of 4 consecutive days. If marginale and anthrax caused by Bacil- no improvement is noted within 24 to lus anthracis. 48 hours, diagnosis and therapy should (C) Limitations. Administer be reevaluated. intramuscularly. Treatment of all dis- (v) When injecting intramuscularly eases should be instituted early and in adult livestock, do not inject more continue for 24 to 48 hours beyond re- than 10 milliliters at any one site. The mission of disease symptoms, but not volume administered per injection site to exceed a total of 4 consecutive days. should be reduced according to age and Consult your veterinarian if no im- body size so that 1 or 2 milliliters are provement is noted within 48 hours. Do injected in smaller animals such as not inject more than 10 milliliters per small calves and young pigs. Intra- site in adult cattle, reducing the vol- venous administration is recommended ume according to age and body size to in cattle when daily dosage exceeds 50 1 to 2 milliliters in small calves. Ex- milliliters. ceeding the highest recommended dose (vi) Treatment must be discontinued of 5 milligrams per pound of body at least 5 days prior to slaughter for weight per day, administering more chickens and turkeys and at least 22 than the recommended number of days prior to slaughter for cattle and treatments, and/or exceeding 10 milli- swine. When administered liters intramuscularly or intramuscularly to animals within 30 subcutaneously per injection site in days of slaughter, muscle discoloration adult beef and dairy cattle may result may necessitate trimming of the injec- in antibiotic residues beyond the with- tion site(s) and surrounding tissues drawal period. Discontinue treatment during the dressing procedure. at least 15 days prior to slaughter. Not (vii) Not for use in lactating dairy for use in lactating dairy cattle. animals. Do not administer to laying (ii) Swine—(A) Amount. 3 to 5 milli- hens unless the eggs are used for hatch- grams of oxytetracycline per pound of ing only. body weight per day. Sows: 3 milli- (f)(1) Specifications. Each milliliter of grams of oxytetracycline per pound of solution contains 100 milligrams of ox- body weight, administered once, ap- ytetracycline hydrochloride. proximately 8 hours before farrowing (2) Sponsor. See No. 054771 in or immediately after completion of § 510.600(c) of this chapter. farrowing. (3) Conditions of use—(i) Beef cattle (B) Indications for use. For treatment and nonlactating dairy cattle—(A) of bacterial enteritis (scours, Amount. 3 to 5 milligrams of oxytetra- colibacillosis) caused by Escherichia cycline per pound of body weight per coli, pneumonia caused by Pasteurella day; 5 milligrams per pound of body multocida, and leptospirosis caused by weight per day for treatment of Leptospira pomona. Sows: as an aid in anaplasmosis, severe foot-rot, and se- control of infections enteritis (baby pig vere cases of other indicated diseases. scours, colibacillosis) in suckling pigs (B) Indications for use. Treatment of caused by Escherichia coli. diseases due to oxytetracycline-suscep- (C) Limitations. Administer tible organisms as follows: Pneumonia intramuscularly. Do not inject more and shipping fever complex associated than 5 milliliters per site in adult with Pasteurella spp. and Haemophilus swine, reducing the volume according spp., foot-rot and diphtheria caused by to age and body size to 1 to 2 milliliters Fusobacterium necrophorum, bacterial in young pigs. Discontinue treatment enteritis (scours) caused by Escherichia at least 22 days prior to slaughter.

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(g)(1) Specifications. Each milliliter of Leptospira pomona. Sows: As an aid in sterile solution contains 100 milligrams control of infectious enteritis (baby pig of oxytetracycline as oxytetracycline scours, colibacillosis) in suckling pigs hydrochloride. caused by Escherichia coli. (2) Sponsor. See No. 069043 in (C) Limitations. Administer § 510.600(c) of this chapter. intramuscularly. If no improvement is (3) Conditions of use. The drug is used noted within 24 hours, consult a veteri- for the treatment of diseases due to ox- narian. Do not inject more than 5 mil- ytetracycline-susceptible organisms as liliters per site. Discontinue treatment follows: at least 20 days prior to slaughter. (i) Beef cattle, beef calves, nonlactating (h)(1) Specifications. Each milliliter of dairy cattle, and dairy calves—(A) sterile solution contains 50 or 100 milli- Amount. 3 to 5 milligrams of oxytetra- grams of oxytetracycline hydro- cycline per pound of body weight per chloride. day. (2) Sponsors. See No. 069043 in (B) Indications for use. For the treat- § 510.600(c) of this chapter for use of 50 ment of pneumonia and shipping fever and 100 milligrams per milliliter solu- complex associated with Pasteurella tion; and Nos. 016592 and 055529 in spp., Haemophilus spp., or Klebsiella spp. § 510.600(c) for use of 100 milligrams per (C) Limitations. Administer by milliliter solution. intramuscular, intravenous, or sub- (3) Conditions of use—(i) Amount. The cutaneous injection. In severe forms of drug is used in beef cattle, beef calves, the indicated diseases, administer 5 nonlactating dairy cattle, and dairy milligrams of oxytetracycline per calves as follows: 3 to 5 milligrams of pound of body weight per day. Continue oxytetracycline hydrochloride per treatment 24 to 48 hours following re- pound of body weight per day; 5 milli- mission of disease symptoms, not to grams per pound of body weight per exceed a total of 4 consecutive days. If day for treatment of severe forms of no improvement is noted within 48 the indicated diseases. hours, consult a veterinarian. Do not (ii) Indications for use. The drug is inject more than 10 milliliters per in- used for treatment of bacterial pneu- jection site intramuscularly in adult monia and shipping fever complex asso- cattle; no more than 1 milliliter per ciated with Pasteurella spp.; foot-rot site in calves weighing 100 pounds or and calf diphtheria caused by less. Do not slaughter cattle for 13 days Fusobacterium necrophorum bacterial after intramuscular or intravenous enterities (scours) caused by Esch- treatment, or 2 days after subcuta- erichia coli; wooden tongue caused by neous treatment. Exceeding the high- Actinobacillus lignieresi; wound infec- est recommended dosage or duration of tions, acute metrities, and traumatic treatment (not more than 4 consecu- injury caused by staphylococcal and tive days) may result in residues be- streptococcal organisms. yond the withdrawal period. A with- (iii) Limitations. Administer 50-milli- drawal period has not been established gram-per-milliliter solution for use of this product in intramuscularly; administer 100-milli- preruminating calves. Do not use in gram-per-milliliter solution intra- calves to be processed for veal. venously. Continue treatment 24 to 48 (ii) Swine—(A) Amount. 3 to 5 milli- hours following remission of disease grams of oxytetracycline per pound of symptoms, not to exceed a total of 4 body weight per day. Sows: Administer consecutive days. If no improvement is once 3 milligrams of oxytetracycline noted within 24 to 48 hours, consult a per pound of body weight, approxi- veterinarian for diagnosis and therapy. mately 8 hours before farrowing or im- When injecting the drug mediately after completion of intramuscularly, do no inject more farrowing. than 10 milliliters per site in adult cat- (B) Indications for use. For treatment tle. Reduce the volume administered of bacterial enteritis (scours, per injection site according to age and colibacillosis) caused by Escherichia body size. In calves weighing 100 coli, pneumonia caused by Pasteurella pounds or less, do no inject more than multocida, and leptospirosis caused by 2 milliliters intramuscularly per site.

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Discontinue treatment at least 22 days weight daily, 5 milligrams per pound before slaughter. Not for use in lac- for anaplasmosis, severe foot rot, and tating dairy animals. A withdrawal pe- severe forms of other diseases. riod has not been established for this (ii) Indications for use. Treatment of product in preruminating calves. Do diseases due to oxytetracycline-suscep- not use in calves to be processed for tible organisms as follows: pneumonia veal. and shipping fever complex associated (i)(1) Specifications. Each milliliter of with Pasteurella spp. and Haemophilus sterile solution contains 50 milligrams spp.; foot rot and diphtheria caused by of oxytetracycline hydrochloride. Fusobacterium necrophorum; bacterial (2) Sponsor. See No. 016592 in enteritis (scours) caused by Escherichia § 510.600(c) of this chapter. coli; wooden tongue caused by (3) Conditions of use—(i) Amount. The Actinobacillus lignieresii; leptospirosis drug is used in beef cattle, beef calves, caused by Leptospira pomona; acute me- nonlactating dairy cattle, and dairy tritis and wound infections caused by calves as follows: Administer 3 to 5 staphylococcal and streptococcal orga- milligrams of the oxytetracycline hy- nisms; if labeled for use by or on the drochloride intramuscularly per pound order of a licensed veterinarian, it may of body weight per day. be used for treatment of anaplasmosis (ii) Indications for use. The drug is caused by Anaplasma marginale and an- used for treatment of bacterial pneu- thrax caused by Bacillus anthracis. monia and shipping fever complex asso- (iii) Limitations. Administer by intra- ciated with Pasteurella spp.; foot-rot venous injection. Treatment should be and diptheria caused by Spherophorus continued 24 to 48 hours following re- necrophorus; bacterial enteritis (scours) mission of disease symptoms, but not caused by Escherichia coli; wooden to exceed a total of 4 consecutive days. tongue caused by Actinobacillus If no improvement occurs within 24 to lignieresi; wound infections and acute 48 hours, reevaluate diagnosis and ther- metritis caused by staphylococcal and apy. Discontinue use at least 19 days streptococcal organisms susceptible to prior to slaughter. Not for use in lac- oxytetracycline. tating dairy cattle. (iii) Limitations. In severe forms of [40 FR 13858, Mar. 27, 1975] the indicated diseases, administer the equivalent of 5 milligrams of oxytetra- EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 522.1662a, see the List of cycline hydrochloride per pound of CFR Sections Affected, which appears in the body weight per day. Continue treat- Finding Aids section of the printed volume ment 24 to 48 hours following remission and at www.govinfo.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 diag- (a) Specifications. The drug contains nosis and therapy. In adult livestock, 50 or 100 milligrams of oxytetracycline do not inject more than 10 milliliters hydrochloride and 2 percent lidocaine at any one site. Reduce the volume ad- in each milliliter of sterile aqueous so- ministered per injection site according lution. to age and body size. In calves weigh- (b) Sponsor. See No. 054771 in ing 100 pounds or less inject only 2 mil- § 510.600(c) of this chapter. liliters per site. Discontinue treatment (c) Conditions of use. (1) The drug is at least 18 days before slaughter. Not indicated for use in the treatment of for use in lactating dairy cattle. diseases of dogs caused by pathogens (j)(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. 061133 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

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aureus, secondary bacterial infections law restricts this drug to use by or on caused by Micrococcus pyogenes var. the order of a licensed veterinarian. albus, Brucella bronchiseptica, Strepto- [76 FR 3489, Jan. 20, 2011, as amended at 79 coccus spp. FR 16192, Mar. 25, 2014] (2) The drug is administered intramuscularly at a recommended § 522.1680 Oxytocin. daily dosage to dogs at 5 milligrams per pound of body weight administered (a) Specifications. Each milliliter in divided doses at 6 to 12 hour inter- (mL) of solution contains 20 USP units vals. Therapy should be continued for oxytocin. at least 24 hours after all symptoms (b) Sponsors. See Nos. 054771 and have subsided. 061133 in § 510.600(c) of this chapter. (3) Federal law restricts this drug to (c) Conditions of use—(1) Amount—(i) use by or on the order of a licensed vet- Obstetrical. Administer drug intra- erinarian. venously, intramuscularly, or subcutaneously under aseptic condi- [40 FR 13858, Mar. 27, 1975, as amended at 48 tions as indicated. The following dos- FR 30615, July 5, 1983; 79 FR 16192, Mar. 25, ages are recommended and may be re- 2014] peated as conditions require:

§ 522.1664 Oxytetracycline and mL U.S.P. units flunixin. (a) Specifications. Each milliliter Cats ...... 0.25 to 0.5 ...... 5 to 10. Dogs ...... 0.25 to 1.5 ...... 5 to 30. (mL) of solution contains 300 milli- Ewes, Sows ...... 1.5 to 2.5 ...... 30 to 50. grams (mg) oxytetracycline base as Cows, Horses ...... 5.0 ...... 100. amphoteric oxytetracycline and 20 mg flunixin base as flunixin meglumine. (ii) Milk letdown. Intravenous admin- (b) Sponsor. See No. 055529 in istration is desirable. The following § 510.600(c) of this chapter. dosage is recommended and may be re- (c) Related tolerances. See §§ 556.286 peated as conditions require: and 556.500 of this chapter. (d) Conditions of use cattle—(1) mL U.S.P. units Amount. Administer once as an Cows ...... 0.5 to 1.0 ...... 10 to 20. intramuscular or subcutaneous injec- Sows ...... 0.25 to 1.0 ...... 5 to 20. tion of 1 mL per 22 pounds (lb) body weight (BW) (13.6 mg oxytetracycline (2) Indications for use. Oxytocin may and 0.9 mg flunixin per lb BW) where be used as a uterine contractor to pre- retreatment of calves and yearlings for cipitate and accelerate normal parturi- bacterial pneumonia is impractical due tion and postpartum evacuation of to husbandry conditions, such as cattle uterine debris. In surgery it may be on range, or where their repeated reused postoperatively following cesar- straint is inadvisable. ean section to facilitate involution and (2) Indications for use. For the treat- resistance to the large inflow of blood. ment of bacterial pneumonia associ- It will contract smooth muscle cells of ated with Pasteurella spp. and for the the mammary gland for milk letdown control of associated pyrexia in beef if the udder is in proper physiological and nonlactating dairy cattle. state. (3) Limitations. Discontinue treat- (3) Limitations. Federal law restricts ment at least 21 days prior to slaughter this drug to use by or on the order of a of cattle. This drug product is not ap- licensed veterinarian. proved for use in female dairy cattle 20 months of age or older, including dry [44 FR 63097, Nov. 2, 1979; 45 FR 1019, Jan. 4, dairy cows. Use in these cattle may 1980] cause drug residues in milk and/or in EDITORIAL NOTE: For FEDERAL REGISTER ci- calves born to these cows. A with- tations affecting § 522.1680, see the List of drawal period has not been established CFR Sections Affected, which appears in the in preruminating calves. Do not use in Finding Aids section of the printed volume calves to be processed for veal. Federal and at www.govinfo.gov.

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§ 522.1684 Pegbovigrastim. subcutaneously. Repeat dosage in 48 hours. (a) Specifications. Each pre-filled, sin- (B) Horses. 2 milliliters per 150 pounds gle-dose syringe contains 15 milligrams of body weight intramuscularly. Re- of pegbovigrastim. peat dosage in 48 hours. (b) Sponsor. See No. 058198 in (C) Dogs. 1 milliliter per 10 to 25 § 510.600(c) of this chapter. pounds of body weight intramuscularly (c) Conditions of use in cattle—(1) or subcutaneously. Repeat dosage in 48 Amount. Administer the first dose (sy- hours. ringe) by subcutaneous injection 7 days (ii) Indications for use. Treatment of prior to the cow’s or heifer’s antici- bacterial infections susceptible to peni- pated calving date. If necessary, the cillin G. first dose may be administered within (iii) Limitations. Not for use in beef a range of 4 to 10 days prior to the an- cattle within 30 days of slaughter. Do ticipated calving date to accommodate not use in horses intended for human management schedules. Administer the consumption. Federal law restricts this second dose (syringe) by subcutaneous drug to use by or on the order of a li- injection within 24 hours after calving. censed veterinarian. (2) Indications for use. For the reduc- (2) Beef cattle—(i) Amount. 2 milli- tion in the incidence of clinical mas- liters per 150 pounds of body weight titis in the first 30 days of lactation in subcutaneously. Repeat dosage in 48 periparturient dairy cows and hours. periparturient replacement dairy heif- (ii) Indications for use. (A) Treatment ers. of bacterial pneumonia (Streptococcus (3) Limitations. Federal law restricts spp., Actinomyces pyogenes, Staphy- this drug to use by or on the order of a lococcus aureus); upper respiratory in- licensed veterinarian. fections such as rhinitis or pharyngitis [81 FR 36789, June 8, 2016, as amended at 81 (A. pyogenes); blackleg (Clostridium FR 48702, July 26, 2016] chauvoei). (B) As in paragraph (d)(2)(ii)(A) of § 522.1696 Penicillin G procaine this section; and prophylaxis of bovine injectable dosage forms. shipping fever in 300- to 500-pound beef calves. § 522.1696a Penicillin G benzathine and penicillin G procaine suspen- (iii) Limitations. Not for use within 30 sion. days of slaughter. For Nos. 000859 and 061133: A withdrawal period has not (a) Specifications. Each milliliter of been established for this product in aqueous suspension contains penicillin pre-ruminating calves. Do not use in G benzathine and penicillin G procaine, calves to be processed for veal. each equivalent to 150,000 units of penicillin G. [66 FR 711, Jan. 4, 2001, as amended at 68 FR (b) Sponsors. See sponsors in 34534, June 10, 2003; 70 FR 21947, Apr. 28, 2005; § 510.600(c) of this chapter for the condi- 70 FR 50182, Aug. 26, 2005; 73 FR 16754, Mar. tions of use in paragraph (d) of this sec- 31, 2008; 75 FR 54017, Sept. 3, 2010; 77 FR 4897, Feb. 1, 2012; 78 FR 17597, Mar. 22, 2013; 79 FR tion as follows: 16192, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; (1) Nos. 054771 and 061133 for use as in 84 FR 8974, Mar. 13, 2019; 85 FR 18120, Apr. 1, paragraph (d)(1) of this section. 2020] (2) Nos. 016592 and 061133 for use as in paragraphs (d)(2)(i), (d)(2)(ii)(A), and § 522.1696b Penicillin G procaine aque- (d)(2)(iii) of this section. ous suspension. (3) No. 054771 for use as in paragraphs (a) Specifications. Each milliliter con- (d)(2)(i), (d)(2)(ii)(B), and (d)(2)(iii) of tains penicillin G procaine equivalent this section. to 300,000 units of penicillin G. (c) Related tolerances. See § 556.510 of (b) Sponsors. See sponsor numbers in this chapter. § 510.600(c) of this chapter as follows: (d) Conditions of use—(1) Horses, dogs, (1) Nos. 016592 and 054771 for use as in and beef cattle—(i) Amount—(A) Beef paragraph (d) of this section. cattle. 2 milliliters per 150 pounds of (2) No. 061133 for use as in paragraph body weight intramuscularly or (d)(2) of this section.

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(c) Related tolerances. See § 556.510 of (c) Conditions of use—(1) Amount. Dogs this chapter. and cats—10,000 units per pound of body (d) Conditions of use—(1) Dogs and weight once daily. Horses—3,000 units cats—(i) Amount. 10,000 units per pound per pound of body weight once daily. body weight daily by intramuscular in- (2) Indications for use. Treatment of jection at 24-hour intervals. Continue infections of dogs, cats, and horses treatment at least 48 hours after symp- caused by penicillin-susceptible orga- toms disappear. nisms such as Streptococci, (ii) Indications for use. Treatment of Staphylococci, and Corynebacteria. infections caused by penicillin-sen- (3) Limitations. Not for use in food- sitive organisms. producing animals. Federal law re- (iii) 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. [57 FR 37333, Aug. 18, 1992, as amended at 79 (2) Cattle, sheep, swine, and horses—(i) FR 16193, Mar. 25, 2014] Amount. 3,000 units per pound body weight (1 milliliter per 100 pounds body § 522.1697 Pentobarbital and phe- weight) daily by intramuscular injec- nytoin. tion. (a) Specifications. Each milliliter (ii) Indications for use. Treatment of (mL) of solution contains 390 milli- cattle and sheep for bacterial pneu- grams (mg) pentobarbital sodium and monia (shipping fever) caused by 50 mg phenytoin sodium. Pasteurella multocida; swine for erysipe- (b) Sponsors. See Nos. 000061, 051311, las caused by Erysipelothrix and 054925 in § 510.600(c) of this chapter. rhusiopathiae; and horses for strangles (c) Special considerations. Product la- caused by Streptococcus equi. beling shall bear the following warning (iii) Limitations. Not for use in horses statements: ‘‘ENVIRONMENTAL HAZ- intended for food. Milk that has been ARD: This product is toxic to wildlife. taken during treatment and for 48 Birds and mammals feeding on treated hours after the last treatment must animals may be killed. Euthanized ani- not be used for food. mals must be properly disposed of by (A) For Nos. 054771 and 061133: Do not deep burial, incineration, or other exceed 7 days of treatment in nonlac- method in compliance with State and tating dairy and beef cattle, sheep, and local laws, to prevent consumption of swine, or 5 days in lactating cattle. carcass material by scavenging wild- Discontinue treatment for the fol- life.’’ lowing number of days before slaugh- (d) Conditions of use in dogs—(1) ter: Nonruminating cattle (calves)—7; Amount. Administer 1 mL per 10 pounds all other cattle—4; sheep—8; and of body weight as a single, bolus intra- swine—6. venous or intracardiac injection. (B) For No. 016592: Continue treat- (2) Indications for use. For humane, ment at least 1 day after symptoms painless, and rapid euthanasia. disappear (usually 2 or 3 days). (3) Limitations. Do not use in animals [66 FR 712, Jan. 4, 2001, as amended at 68 FR intended for food. Federal law restricts 34534, June 10, 2003; 68 FR 42589, July 18, 2003; this drug to use by or on the order of a 69 FR 17586, Apr. 5, 2004; 70 FR 16935, Apr. 4, licensed veterinarian. 2005; 73 FR 14177, Mar. 17, 2008; 75 FR 54017, Sept. 3, 2010; 78 FR 17597, Mar. 22, 2013; 79 FR [85 FR 18120, Apr. 1, 2020] 16192, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; 84 FR 8974, Mar. 13, 2019; 85 FR 18120, Apr. 1, § 522.1698 Pentazocine. 2020] (a) Specifications. Each milliliter of solution contains pentazocine lactate § 522.1696c Penicillin G procaine in equivalent to 30 milligrams (mg) of oil. pentazocine base. (a) Specifications. Each milliliter con- (b) Sponsor. See No. 054771 in tains penicillin G procaine equivalent § 510.600(c) of this chapter. to 300,000 units of penicillin G. (c) Conditions of use—(1) Horses—(i) (b) Sponsor. See No. 054771 in Amount. Administer 0.15 mg § 510.600(c) of this chapter. pentazocine base per pound of body

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weight daily by intravenous or (3) Limitations. Do not use in horses intramuscular injection. In cases of se- intended for human consumption. Fed- vere pain, a second dose is rec- eral law restricts this drug to use by or ommended by intramuscular injection on the order of a licensed veterinarian. 10 to 15 minutes after the initial dose at the same level. [79 FR 16193, Mar. 25, 2014] (ii) Indications for use. For sympto- § 522.1720 Phenylbutazone. matic relief of pain due to colic. (iii) Limitations. Do not use in horses (a) Specifications—(1) Each milliliter intended for human consumption. Fed- of solution contains 100 milligrams eral law restricts this drug to use by or (mg) of phenylbutazone. on the order of a licensed veterinarian. (2) Each milliliter of solution con- (2) Dogs—(i) Amount. Administer 0.75 tains 200 mg of phenylbutazone. to 1.50 mg of pentazocine base per (b) Sponsors. See sponsor numbers in pound of body weight by intramuscular § 510.600(c) of this chapter for use as in injection. paragraph (c) of this section: (ii) Indications for use. For ameliora- (1) No. 054771 for use of product de- tion of pain accompanying post- scribed in paragraph (a)(1) as in para- operative recovery, fracture, trauma, graph (c) of this section. and spinal disorders. (2) Nos. 000061, 000859, 054771, and (iii) Limitations. Federal law restricts 061133 for use of product described in this drug to use by or on the order of a paragraph (a)(2) as in paragraph (c) of licensed veterinarian. this section. [42 FR 31450, June 21, 1977, as amended at 42 (3) Nos. 058005 and 069043 for use of FR 36995, July 19, 1977; 47 FR 5409, Feb. 5, product described in paragraph (a)(2) as 1982; 55 FR 23076, June 6, 1990; 79 FR 16193, in paragraph (c)(2) of this section. Mar. 25, 2014] (c) Conditions of use—(1) Dogs—(i) Amount. Administer by intravenous in- § 522.1704 Pentobarbital. jection 10 mg per pound of body weight (a) Specifications. Each milliliter of daily in three divided doses, not to ex- solution contains 64.8 milligrams (mg) ceed 800 mg daily regardless of weight. of sodium pentobarbital. Limit intravenous administration to 2 (b) Sponsor. See No. 000061 in successive days. Oral medication may § 510.600(c) of this chapter. follow. (c) Conditions of use—(1) Amount. The (ii) Indications for use. It is used for drug is administered intravenously ‘‘to the relief of inflammatory conditions effect’’. For general surgical anes- associated with the musculoskeletal thesia, the usual dose is 11 to 13 mg per system. pound of body weight. For sedation, (iii) Limitations. Federal law restricts the usual dose is approximately 2 mg this drug to use by or on the order of a per pound of body weight. For relieving licensed veterinarian. convulsive seizures caused by strych- (2) Horses—(i) Amount. Administer by nine in dogs, the injection should be intravenous injection 1 to 2 grams (g) administered intravenously ‘‘to ef- per 1,000 pounds of body weight daily in fect’’. The drug may be administered three divided doses, not to exceed 4 g intraperitoneally. When given daily. Limit intravenous administra- intraperitoneally, it is administered at tion to not more than 5 successive the same dosage level as for intra- days. venous administration. (2) Indications for use. The drug is in- (ii) Indications for use. For the relief dicated for use as a general anesthetic of inflammatory conditions associated in dogs and cats. Although it may be with the musculoskeletal system. used as a general surgical anesthetic (iii) Limitations. Do not use in horses for horses, it is usually given at a intended for human consumption. Fed- lower dose to cause sedation and hyp- eral law restricts this drug to use by or nosis and may be supplemented with a on the order of a licensed veterinarian. local anesthetic. It may also be used in [79 FR 16193, Mar. 25, 2014, as amended at 83 dogs for the symptomatic treatment of FR 48946, Sept. 28, 2018; 84 FR 8974, Mar. 13, strychnine poisoning. 2019]

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§ 522.1820 Pituitary luteinizing hor- (2) Dogs—(i) Indications for use. For mone powder for injection. control of signs associated with non- (a) Specifications. The drug is a infectious degenerative and/or trau- lyophilized pituitary extract. Each 6- matic arthritis of canine synovial milliliter vial contains an amount joints. equivalent to 25 milligrams of standard (ii) Amount. 2 mg per pound of body pituitary luteinizing hormone and is weight by intramuscular injection reconstituted for use by addition of 5 twice weekly for up to 4 weeks (max- milliliters of 0.9 percent aqueous so- imum of 8 injections). dium chloride solution. (b) Sponsor. No. 000061 in § 510.600(c) of [72 FR 56896, Oct. 5, 2007, as amended at 74 FR 67816, Dec. 21, 2009] this chapter. (c) Conditions of use—(1) Amount. Cat- § 522.1862 Pralidoxime powder for in- tle and horses: 25 milligrams; swine: 5 jection. milligrams; sheep: 2.5 milligrams; and 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. to pituitary hypofunction in cattle, (b) Sponsor. See No. 054771 in horses, swine, sheep, and dogs. § 510.600(c) of this chapter. (3) Limitations. Federal law restricts (c) Conditions of use—(1) Amount. Ad- this drug to use by or on the order of a minister as soon as possible after expo- licensed veterinarian. sure to the poison. Before administra- [40 FR 13858, Mar. 27, 1975, as amended at 52 tion of the sterile pralidoxime chloride, FR 7832, Mar. 13, 1987; 79 FR 16193, Mar. 25, atropine is administered intravenously 2014] at a dosage rate of 0.05 mg per pound of body weight, followed by administra- § 522.1850 Polysulfated tion of an additional 0.15 mg of atro- glycosaminoglycan. pine per pound of body weight adminis- (a) Specifications. (1) Each 1-milliliter tered intramuscularly. Then the appro- (mL) ampule of solution contains 250 priate dosage of sterile pralidoxime milligrams (mg) polysulfated chloride is administered slowly intra- glycosaminoglycan. venously. The dosage rate for sterile (2) Each mL of solution packaged in pralidoxime chloride when adminis- 5-mL ampules or 20-, 30-, or 50-mL vials tered to horses is 2 g per horse. When contains 100 mg polysulfated administered to dogs and cats, it is 25 glycosaminoglycan. mg per pound of body weight. For (b) Sponsor. See No. 010797 in small dogs and cats, sterile § 510.600(c) of this chapter. pralidoxime chloride may be adminis- (c) Special considerations. Federal law tered either intraperitoneally or restricts this drug to use by or on the order of a licensed veterinarian. intramuscularly. A mild degree of (d) Conditions of use—(1) Horses—(i) atropinization should be maintained Indications for use. For the treatment of for at least 48 hours. Following severe noninfectious degenerative and/or trau- poisoning, a second dose of sterile matic joint dysfunction and associated pralidoxime chloride may be given lameness of the carpal and hock joints after 1 hour if muscle weakness has not in horses. been relieved. (ii) Amount—(A) Intra-articular use (2) Indications for use. It is used in (carpal): 250 mg once a week for 5 horses, dogs, and cats as an antidote in weeks. the treatment of poisoning due to (B) Intramuscular use (carpal and those pesticides and chemicals of the hock): 500 mg every 4 days for 28 days. organophosphate class which have (iii) Limitations. Do not use in horses anticholinesterase activity in horses, intended for human consumption. dogs, and cats.

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(3) Limitations. Federal law restricts oral corticosteroid may be given as a this drug to use by or on the order of a maintenance dosage. The drug may be licensed veterinarian. given intra-articularly to dogs and cats [79 FR 16193, Mar. 25, 2014] at a dosage level of 5 to 25 mg. The dose may be repeated when necessary after 7 § 522.1870 Praziquantel. days for two or three doses. (2) Indications for use. The drug is in- (a) Specifications. Each milliliter (mL) of solution contains 56.8 milli- dicated in the treatment of dogs, cats, grams of praziquantel. and horses for conditions requiring an (b) Sponsors. See Nos. 000859 and anti-inflammatory agent. The drug is 061133 in § 510.600(c) of this chapter. indicated for the treatment of acute (c) Conditions of use—(1) Dogs—(i) musculoskeletal inflammations such as Amount. Administer by subcutaneous bursitis, carpitis, and spondylitis. The or intramuscular injection for dogs and drug is indicated as supportive therapy puppies 5 pounds (lb) and under, 0.3 mL; in nonspecific dermatosis such as sum- for 6 to 10 lb, 0.5 mL; for 11 to 25 lb, 1.0 mer eczema and atopy. The drug may mL; if over 25 lb, 0.2 mL/5 lb body be used as supportive therapy pre- and weight to a maximum of 3 mL. postoperatively and for various stress (ii) Indications for use. For removal of conditions when corticosteroids are re- canine cestodes Dipylidium caninum, quired while the animal is being treat- Taenia pisiformis, and Echinococcus ed for a specific condition. granulosus, and removal and control of (3) Limitations. Do not use in horses canine cestode Echinococcus intended for human consumption. Fed- multilocularis. eral law restricts this drug to use by or (iii) Limitations. Federal law restricts on the order of a licensed veterinarian. the drug to use by or on the order of a [79 FR 16194, Mar. 25, 2014] licensed veterinarian. (2) Cats—(i) Amount. Administer by § 522.1883 Prednisolone sodium phos- subcutaneous or intramuscular injec- phate. tion for cats and kittens under 5 lb, 0.2 (a) Specifications. Each milliliter of mL; 5 to 10 lb, 0.4 mL; 11 lb and over, solution contains 20 milligrams (mg) 0.6 mL maximum. prednisolone sodium phosphate (equiv- (ii) For removal of Indications for use. alent to 14.88 mg of prednisolone). feline cestodes Dipylidium caninum and (b) Sponsor. See No. 061133 in Taenia taeniaeformis. § 510.600(c) of this chapter. (iii) Limitations. Federal law restricts (c) Conditions of use in dogs—(1) the drug to use by or on the order of a licensed veterinarian. Amount. Administer intravenously in a dosage of 21⁄2 to 5 mg per pound of body [46 FR 10464, Feb. 3, 1981, as amended at 47 weight, initially for shock and shock- FR 6617, Feb. 16, 1982; 58 FR 42853, Aug. 12, like states, followed by equal mainte- 1993; 67 FR 79853, Dec. 31, 2002; 78 FR 17868, nance doses at 1-, 3-, 6-, or 10-hour in- Mar. 25, 2013; 81 FR 67151, Sept. 30, 2016; 84 FR 8974, Mar. 13, 2019] tervals as determined by the condition of the animal. § 522.1881 Prednisolone acetate. (2) Indications for use. Administer (a) Specifications. Each milliliter of when a rapid adrenal glucocorticoid suspension contains 25 milligrams (mg) and/or anti-inflammatory effect is nec- of prednisolone acetate. essary. (b) Sponsor. See No. 000061 in (3) Limitations. Federal law restricts § 510.600(c) of this chapter. this drug to use by or on the order of a (c) Conditions of use—(1) Amount. The licensed veterinarian. drug is administered to horses intra- [68 FR 59881, Oct. 20, 2003, as amended at 84 articularly at a dosage level of 50 to 100 FR 8974, Mar. 13, 2019] mg. The dose may be repeated when necessary. The drug is administered to § 522.1884 Prednisolone sodium succi- dogs and cats intramuscularly at a dos- nate. age level of 10 to 50 mg. The dosage (a) Specifications. Each milliliter of may be repeated when necessary. If the prednisolone sodium succinate injec- condition is of a chronic nature, an tion contains: Prednisolone sodium

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succinate equivalent in activity to 10, horses in 24 to 48 hours may be nec- 20, or 50 milligrams (mg) of prednis- essary, depending on the general condi- olone. tion of the animal and the severity and (b) Sponsor. See No. 054771 in duration of the disease. § 510.600(c) of this chapter for products (ii) Dogs and cats: Administer by containing 10, 20, and 50 mg equivalent intramuscular injection 1 mg per 5 prednisolone activity per milliliter for pounds of body weight or use in horses, dogs, and cats as pro- intrasynovially at a dosage level of 10 vided in paragraphs (c)(1)(i), (ii), and to 20 mg. (iii) of this section. (2) Indications for use. It is used as an (c) Conditions of use—(1) Amount and anti-inflammatory agent in horses, indications for use—(i) Horses. Admin- dogs, and cats. ister 50 to 100 mg as an initial dose by (3) Limitations. Do not use in horses intravenous injection over a period of intended for human consumption. Fed- one-half to 1 minute, or by eral law restricts this drug to use by or intramuscular injection, and may be on the order of a licensed veterinarian. repeated in inflammatory, allergic, or other stress conditions at intervals of [79 FR 16194, Mar. 25, 2014, as amended at 84 12, 24, or 48 hours, depending upon the FR 39184, Aug. 9, 2019] size of the animal, the severity of the § 522.1890 Sterile prednisone suspen- condition and the response to treat- sion. ment. (ii) Dogs. Administer by intravenous (a) Specifications. Each milliliter of injection at a range of 2.5 to 5 mg per suspension contains 10 to 40 milligrams pound of body weight as an initial dose (mg) of prednisone. followed by maintenance doses at 1, 3, (b) Sponsor. See No. 000061 in 6, or 10 hour intervals, as determined § 510.600(c) of this chapter. by the condition of the animal, for (c) Conditions of use—(1) Amount—(i) treatment of shock. Horses. Administer 100 to 400 mg by (iii) Dogs and cats. Administer by intramuscular injection, repeating if intramuscular injection for treatment necessary. of inflammatory, allergic, and less se- (ii) Dogs and cats. Administer 0.25 to vere stress conditions, where imme- 1.0 mg per pound of body weight by diate effect is not required, at 1 to 5 mg intramuscular injection for 3 to 5 days ranging upward to 30 to 50 mg in large or until a response is noted. Treatment breeds of dogs. Dosage may be repeated may be continued with an orally ad- in 12 to 24 hours and continued for 3 to ministered dose. 5 days if necessary. If permanent (2) Indications for use. It is used for corticosteroid effect is required, oral conditions requiring an anti-inflam- therapy with prednisolone tablets may matory agent. be substituted. (3) Limitations. Do not use in horses (2) Limitations. Do not use in horses intended for human consumption. Fed- intended for human consumption. Fed- eral law restricts this drug to use by or eral law restricts this drug to use by or on the order of a licensed veterinarian. on the order of a licensed veterinarian. [79 FR 16194, Mar. 25, 2014] [79 FR 16194, Mar. 25, 2014] § 522.1920 Prochlorperazine and § 522.1885 Prednisolone tertiary isopropamide. butylacetate. (a) Specifications. Each milliliter of (a) Specifications. Each milliliter of solution contains prochlorperazine suspension contains 20 milligrams (mg) edisylate equivalent to 4 milligrams of prednisolone tertiary butylacetate. (mg) prochlorperazine and (b) Sponsor. See No. 000010 in isopropamide iodide equivalent to 0.28 § 510.600(c) of this chapter. mg of isopropamide. (c) Conditions of use—(1) Amount—(i) (b) Sponsor. See No. 054771 in Horses: Administer by intramuscular § 510.600(c) of this chapter. injection 100 to 300 mg or by (c) Conditions of use—(1) Amount. (i) intrasynovial injection at a dosage Dosage is administered by subcuta- level of 50 to 100 mg. Retreatment of neous injection twice daily as follows:

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tablished in veal calves. A withdrawal Weight of animal in pounds Dosage in milliliters period has not been established for this Up to 4 ...... 0.25 product in preruminating calves. Do 5 to 14 ...... 0.5–1 not use in calves to be processed for 15 to 30 ...... 2–3 veal. 30 to 45 ...... 3–4 45 to 60 ...... 4–5 (2) Steers—(i) Amount. (A) 200 mg pro- Over 60 ...... 6 gesterone and 20 mg estradiol benzoate (one implant consisting of 8 pellets, (ii) Following the last injection, ad- each pellet containing 25 mg progester- minister prochlorperazine and one and 2.5 mg estradiol benzoate) per isopropamide sustained release cap- implant dose. sules as indicated. (B) 200 mg progesterone and 20 mg es- (2) Indications for use. For use in dogs tradiol benzoate (one implant con- and cats in which gastrointestinal dis- sisting of 9 pellets, each of 8 pellets turbances are associated with emo- containing 25 mg progesterone and 2.5 tional stress. mg estradiol benzoate, and 1 pellet con- (3) Limitations. Federal law restricts taining 29 mg tylosin tartrate) per im- this drug to use by or on the order of a plant dose. licensed veterinarian. (ii) Indications for use. For increased [79 FR 16194, Mar. 25, 2014] rate of weight gain and improved feed efficiency. § 522.1940 Progesterone and estradiol (iii) Limitations. For animals weigh- benzoate. ing 400 lb or more; for subcutaneous ear (a) Sponsors. See sponsors in implantation, one dose per animal. § 510.600(c) of this chapter for use as in Safety and effectiveness have not been paragraph (c) of this section: established in veal calves. A with- (1) No. 054771 for use as in paragraphs drawal period has not been established (c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), for this product in preruminating (c)(2)(i)(A), (c)(2)(ii), (c)(2)(iii), and calves. Do not use in calves to be proc- (c)(3) of this section. essed for veal. (2) No. 058198 for use as in paragraphs (3) Steers fed in confinement for slaugh- (c)(1) and (c)(2) of this section. ter—(i) Amount. Reimplant 200 mg pro- (b) Related tolerances. See §§ 556.240 gesterone and 20 mg estradiol benzoate and 556.540 of this chapter. on approximately day 70 following an (c) Conditions of use in cattle. It is initial implant of 100 mg progesterone used for implantation as follows: and 10 mg estradiol benzoate or 200 mg (1) Suckling beef calves—(i) Amount. progesterone and 20 mg estradiol ben- (A) 100 milligrams (mg) progesterone zoate. and 10 mg estradiol benzoate (one im- (ii) Indications for use. For additional plant consisting of 4 pellets, each pel- improvement in rate of weight gain. let containing 25 mg progesterone and (iii) Limitations. For subcutaneous ear 2.5 mg estradiol benzoate) per implant implantation. Safety and effectiveness dose. have not been established in veal (B) 100 mg progesterone and 10 mg es- calves. A withdrawal period has not tradiol benzoate (one implant con- been established for this product in sisting of 5 pellets, each of 4 pellets preruminating calves. Do not use in containing 25 mg progesterone and 2.5 calves to be processed for veal. mg estradiol benzoate, and 1 pellet containing 29 mg tylosin tartrate) per im- [69 FR 70055, Dec. 2, 2004, as amended at 77 plant dose. FR 31723, May 30, 2012; 79 FR 16194, Mar. 25, (ii) Indications for use. For increased 2014; 81 FR 48702, July 26, 2016] rate of weight gain. (iii) Limitations. For use in suckling § 522.1962 Promazine. beef calves (at least 45 days of age) up (a) Specifications. Each milliliter of to 400 pounds (lb) of body weight. For solution contains 50 milligrams (mg) subcutaneous ear implantation, one promazine hydrochloride. dose per animal. Do not use in bull (b) Sponsors. See sponsors in calves intended for reproduction. Safe- § 510.600(c) of this chapter for use as in ty and effectiveness have not been es- paragraph (c) of this section:

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(1) No. 054771 for use as in paragraphs (2) Limitations. Federal law restricts (c)(1)(i)(A), (c)(1)(ii)(A), (c)(1)(iii), and this drug to use by or on the order of a (c)(2) of this section. licensed veterinarian. (2) No. 061133 for use as in paragraphs [79 FR 16195, Mar. 25, 2014] (c)(1)(i)(B), (c)(1)(ii)(B), and (c)(1)(iii) of this section. § 522.2005 Propofol. (c) Conditions of use—(1) Horses—(i) (a) Specifications. Each milliliter of Amount. (A) 0.2 to 0.5 milligrams per emulsion contains 10 milligrams (mg) pounds (mg/lb) body weight propofol. intramuscularly or intravenously (b) Sponsors. See sponsor numbers in every 4 to 6 hours. § 510.600(c) of this chapter. (B) 0.2 to 0.5 mg/lb body weight intra- (1) No. 086064 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 (2) No. 054771 for use as in paragraph a tranquilizer, preanesthetic, or for (c) of this section. minor operative procedures in conjunc- (c) Conditions of use in dogs and cats— tion with local anesthesia; and as ad- (1) Amount. Administer by intravenous junctive therapy for tetanus. injection according to label directions. (B) For use as a tranquilizer and The use of preanesthetic medication preanesthetic. reduces propofol dose requirements. (iii) Limitations. Do not use in horses (2) Indications for use. (i) As a single intended for human consumption. Fed- injection to provide general anesthesia eral law restricts this drug to use by or for short procedures; for induction and on the order of a licensed veterinarian. maintenance of general anesthesia using incremental doses to effect; for (2) Dogs and cats—(i) Amount. 1 to 2 induction of general anesthesia where mg/lb body weight intramuscularly or maintenance is provided by inhalant intravenously every 4 to 6 hours. anesthetics. (ii) Indications for use. For use as a (ii) For the induction and mainte- tranquilizer, preanesthetic, for minor nance of anesthesia and for induction operative procedures in conjunction of anesthesia followed by maintenance with local anesthesia, as adjunctive with an inhalant anesthetic. therapy for tetanus, and as an (3) Limitations. Federal law restricts antiemetic prior to worming; or to pre- this drug to use by or on the order of a vent motion sickness in dogs. licensed veterinarian. (iii) Limitations. Federal law restricts this drug to use by or on the order of a [75 FR 20269, Apr. 19, 2010, as amended at 75 FR 38700, July 6, 2010; 78 FR 17868, Mar. 25, licensed veterinarian. 2013; 79 FR 16195, Mar. 25, 2014; 80 FR 18776, [46 FR 18962, Mar. 27, 1981, as amended at 68 Apr. 8, 2015; 81 FR 36789, June 8, 2016] FR 59881, Oct. 20, 2003; 70 FR 50183, Aug. 26, 2005; 79 FR 16194, Mar. 25, 2014; 84 FR 8974, § 522.2012 Prostalene. Mar. 13, 2019] (a) Specifications. Each milliliter of solution contains 1 milligram of § 522.2002 Propiopromazine. prostalene. (a) Specifications. Each milliliter of (b) Sponsor. No. 054771 in § 510.600(c) of solution contains 5 or 10 milligrams this chapter. (mg) propiopromazine hydrochloride. (c) Conditions of use in horses—(1) (b) Sponsor. See No. 054771 in Amount. Administer 5 micrograms per § 510.600(c) of this chapter. kilogram of body weight as a single (c) Conditions of use in dogs and cats— subcutaneous injection. (1) Amounts and indications for use. Ad- (2) Indications for use. For the control minister 0.05 to 0.5 mg per pound of of estrus in mares. body weight by intravenous or (3) Limitations. Do not use in horses intramuscular injection for intended for human consumption. Fed- tranquilization. Administer 0.25 mg per eral law restricts this drug to use by or on the order of a licensed veterinarian. pound of body weight by intravenous injection as a preanesthetic. [79 FR 16195, Mar. 25, 2014]

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§ 522.2063 Pyrilamine. (iii) Limitations. Federal law restricts this drug to use by or on the order of a (a) Specifications. Each milliliter of licensed veterinarian. solution contains 20 milligrams (mg) of pyrilamine maleate. (2) Cats—(i) Amount. Administer 0.91 mg per pound (2 mg/kg) by subcuta- (b) Sponsors. See sponsor numbers in neous injection, once daily, for a max- § 510.600(c) of this chapter for uses in imum of 3 days. paragraph (c) of this section. (ii) Indications for use. For the control (1) No. 000061 for use as in paragraph of postoperative pain and inflamma- (c)(1)(i), (2), and (3) of this section. tion associated with orthopedic sur- (2) No. 061133 for use as in paragraph gery, ovariohysterectomy, and castra- (c)(1)(ii), (2), and (3) of this section. tion in cats at least 4 months of age for (c) Conditions of use—(1) Amount. (i) a maximum of 3 days. Horses, 40 to 60 mg per 100 pounds (lbs) (iii) Limitations. Federal law restricts body weight; foals, 20 mg/100 lbs body this drug to use by or on the order of a weight. Administer by intramuscular, licensed veterinarian. subcutaneous, or intravenous injection. Dosage may be repeated every 6 to 12 [80 FR 61297, Oct. 13, 2015, as amended at 82 hours whenever necessary. FR 12170, Mar. 1, 2017] (ii) Horses, 40 to 60 mg/100 lbs body weight; foals, 20 mg/100 lbs body § 522.2076 Romifidine. weight. Administer by slow intra- (a) Specifications. Each milliliter of venous injection. Dosage may be resolution contains 10 milligrams (mg) peated every 6 to 12 hours if necessary. romifidine hydrochloride. (2) Indications for use. It is intended (b) Sponsor. See No. 000010 in for treating horses in conditions in § 510.600(c) of this chapter. which antihistaminic therapy may be (c) Conditions of use in horses—(1) expected to lead to alleviation of some Amount. 40 to 120 micrograms per kilo- signs of disease. gram of body weight (mcg/kg BW) in- (3) Limitations. Do not use in horses travenously for sedation and analgesia; intended for human consumption. Fed- 100 mcg/kg BW intravenously as a eral law restricts this drug to use by or preanesthetic. on the order of a licensed veterinarian. (2) Indications for use. For use as a sedative and analgesic to facilitate [79 FR 16195, Mar. 25, 2014, as amended at 84 FR 8974, Mar. 13, 2019] handling, clinical examinations, clinical procedures, and minor surgical § 522.2075 Robenacoxib. procedures in adult horses; and for use as a preanesthetic prior to the induc- (a) Specifications. Each milliliter of tion of general anesthesia in adult solution contains 20 milligrams (mg) horses. robenacoxib. (3) Do not use in horses (b) Sponsor. See No. 058198 in Limitations. § 510.600(c) of this chapter. intended for human consumption. Fed- eral law restricts this drug to use by or (c) Conditions of use—(1) Dogs—(i) on the order of a licensed veterinarian. Amount. Administer 0.91 mg per pound (2 mg/kilogram (kg)) by subcutaneous [69 FR 47363, Aug. 5, 2004, as amended at 79 injection, once daily, for a maximum of FR 16195, Mar. 25, 2014] 3 days. After the initial subcutaneous dose, subsequent doses can be given by § 522.2092 Secobarbital and dibucaine. subcutaneous injection or as the oral (a) Specifications. Each milliliter tablet in dogs weighing at least 5.5 (mL) of solution contains 400 milligram pounds (2.5 kg) and at least 4 months of (mg) secobarbital sodium and 25 mg di- age, for a maximum of 3 total doses bucaine hydrochloride. over 3 days, not to exceed 1 dose per (b) Sponsor. See No. 054771 in day. See § 520.2075(c)(1) of this chapter. § 510.600(c) of this chapter. (ii) Indications for use. For the control (c) Special considerations. Product la- of postoperative pain and inflamma- beling shall bear the following warning tion associated with soft tissue surgery statements: ‘‘ENVIRONMENTAL HAZ- in dogs at least 4 months of age for a ARD: This product is toxic to wildlife. maximum of 3 days. Birds and mammals feeding on treated

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animals may be killed. Euthanized ani- peutic response is observed. A mainte- mals must be properly disposed of by nance regimen is then initiated which deep burial, incineration, or other consists of 1 mL per 40 lbs of body method in compliance with State and weight with a minimum dosage of 1⁄4 local laws, to prevent consumption of mL which is repeated every 3 days or 7 carcass material by scavenging wild- days, or longer, as required to main- life.’’ tain continued improvement or an (d) Conditions of use in dogs—(1) asymptomatic condition; or the drug Amount. Administer 1 mL per 10 pounds may be used in capsule form for oral of body weight as a single, bolus intra- maintenance therapy. venous injection. (ii) Indications for use. As an aid in al- (2) Indications for use. For humane, leviating and controlling inflamma- painless, and rapid euthanasia. tion, pain, and lameness associated (3) Limitations. Do not use in animals with certain arthropathies in dogs. intended for food. Federal law restricts (iii) Limitations. Federal law restricts this drug to use by or on the order of a this drug to use by or on the order of a licensed veterinarian. licensed veterinarian. [85 FR 18120, Apr. 1, 2020] (c)(1) Specifications. Each milliliter contains 2.19 milligrams of selenite so- § 522.2100 Selenium and vitamin E. dium (equivalent to 1 milligram sele- (a)(1) Specifications. Each milliliter of nium), 50 milligrams vitamin E (68 emulsion contains 5.48 milligrams (mg) U.S.P. units). sodium selenite (equivalent to 2.5 mg (2) Sponsor. See No. 000061 in selenium) and 50 mg of vitamin E (68 § 510.600(c) of this chapter. I.U.) (as d-alpha tocopheryl acetate). (3) Conditions of use—(i) Dosage. (2) Sponsor. See No. 000061 in Calves: 2.5 to 3.75 milliliters per 100 § 510.600(c) of this chapter. pounds of body weight. Lambs 2 weeks (3) Conditions of use in horses—(i) of age or older: 1 milliliter per 40 Amount. Administer 1 milliliter (mL) pounds, minimum 1 milliliter. Ewes: 2.5 per (/) 100 pounds (lbs) of body weight milliliters per 100 pounds. Sows: 1 mil- by intravenous injection or by deep liliter per 40 pounds. Weanling pigs: 1 intramuscular injection in divided milliliter per 40 pounds, minimum 1 doses in two or more sites in the glu- milliliter. teal or cervical muscles. Administra- (ii) Indications for use. Calves, lambs, tion may be repeated at 5 to 10 day in- and ewes: prevention and treatment of tervals. white muscle disease (selenium-tocoph- (ii) Indications for use. For the pre- erol deficiency syndrome). Sows and vention and treatment of selenium-to- weanling pigs: an aid in the prevention copherol deficiency syndrome in and treatment of selenium-tocopherol horses. deficiency. (iii) Limitations. Do not use in horses (iii) Limitations. For subcutaneous or intended for human consumption. Fed- intramuscular use. Not for use in new- eral law restricts this drug to use by or born pigs. Do not use in pregnant ewes. on the order of a licensed veterinarian. Calves: Discontinue use 30 days before (b)(1) Specifications. Each milliliter treated calves are slaughtered for contains 2.19 mg of sodium selenite human consumption. Lambs, ewes, (equivalent to 1 mg of selenium), 50 mg sows, or pigs: Discontinue use 14 days of vitamin E (68 I.U.) (as d-alpha before treated lambs, ewes, sows, or tocopheryl acetate). 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. Amount. Administer by subcutaneous (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 dosage of 1⁄4 mL and a maximum dosage 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.

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(3) Conditions of use—(i) Dosage. after calving and continue until the Breeding beef cows: 1 milliliter per 200 end of lactation. pounds of body weight during the mid- (2) Indications for use. To increase dle third of gestation, and 30 days be- production of marketable milk in fore calving. Weanling calves: 1 milli- healthy lactating dairy cows. liter per 200 pounds of body weight. (3) Limitations. Use in lactating dairy (ii) Indications for use. Weanling cows only. Safety to replacement bulls calves and breeding beef cows: For the born to treated dairy cows has not been prevention and treatment of selenium- established. Inject subcutaneously. tocopherol deficiency syndrome. Avoid injections within 2 weeks of ex- (iii) Limitations. For subcutaneous or pected slaughter to minimize injection intramuscular use. Discontinue use 30 site blemishes on carcass. There is no days before treated cattle are slaugh- milk discard or preslaughter with- tered for human consumption. Federal drawal period. Use may reduce preg- law restricts this drug to use by or on nancy rates and increase days open. the order of a licensed veterinarian. Treated cows are at an increased risk (e)(1) Specifications. Each milliliter for mastitis and higher milk somatic contains 0.55 milligram selenite sodium cell counts. Use care to differentiate (equivalent to 0.25 milligram sele- increased body temperature due to use nium), 50 milligrams (68 U.S.P. units) of this product from an increased body vitamin E. temperature that may occur due to ill- (2) Sponsor. See No. 000061 in ness. Cows treated with this product § 510.600(c) of this chapter. may have more enlarged hocks and dis- (3) Conditions of use—(i) Dosage. New- orders of the foot region. Use may re- born lambs: 1 milliliter. Lambs 2 weeks duce hemoglobin and hematocrit val- of age or older: 4 milliliters. Baby pigs: ues during treatment. Human warning: 1 milliliter (or treat the sow during the Avoid prolonged or repeated contact last week of pregnancy). with eyes and skin. (ii) Indications for use. Lambs: for pre- [58 FR 59947, Nov. 12, 1993, as amended at 67 vention and treatment of white muscle FR 18085, Apr. 15, 2002; 68 FR 62006, Oct. 31, disease (selenium-tocopherol deficiency 2003; 74 FR 53164, Oct. 16, 2009; 81 FR 48702, syndrome). Baby pigs: an aid in the July 26, 2016; 85 FR 4208, Jan. 24, 2020] prevention and treatment of selenium- tocopherol deficiency. § 522.2120 Spectinomycin (iii) Limitations. For subcutaneous or dihydrochloride injection. intramuscular use only. Discontinue (a) Specifications. The spectinomycin use 14 days before treated animals are dihydrochloride pentahydrate used in slaughtered for human consumption. manufacturing the drug is the anti- Federal law restricts this drug to use biotic substance produced by the by or on the order of a licensed veteri- growth of Streptomyces flavopersicus narian. (var. Abbott) or the same antibiotic substance produced by any other [40 FR 13858, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987; 57 FR 21209, May 19, means. Each milliliter of the drug con- 1992; 58 FR 57556, Oct. 26, 1993; 60 FR 57833, tains the following amount of Nov. 22, 1995; 64 FR 27916, May 24, 1999; 79 FR spectinomycin activity from 16195, Mar. 25, 2014] spectinomycin dihydrochloride pentahydrate: § 522.2112 Sometribove zinc suspen- (1) 5 milligrams when used as pro- sion. vided in paragraph (d)(1) of this sec- (a) Specifications. Each single-dose sy- tion. ringe contains 500 milligrams (mg) (2) [Reserved] sometribove zinc in a prolonged-release (3) 100 milligrams when used as pro- suspension. vided in paragraphs (d) (2), (3), and (4) (b) Sponsor. See No. 086106 in of this section. § 510.600(c) of this chapter. (b) Sponsor. In § 510.600 of this chap- (c) Conditions of use—(1) Amount. In- ter, see No. 016592 for conditions of use ject 500 mg every 14 days starting dur- as in paragraph (d) of this section, and ing the 9th or 10th week (57 to 70 days) see No. 054771 for conditions of use as

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in paragraph (d)(2) and (d)(4) of this fate tetrahydrate equivalent to 100 mil- section. ligrams (mg) spectinomycin. (c) Related tolerances. See § 556.600 of (b) Sponsor. See No. 054771 in this chapter. § 510.600(c) of this chapter. (d) Special considerations. The quan- (c) Related tolerances. See § 556.600 of tity of spectinomycin referred to in this chapter. this section refers to the equivalent (d) Conditions of use in cattle—(1) weight of base activity for the drug. Amount. 10 to 15 mg per kilogram of (e) Conditions of use. It is adminis- body weight at 24-hour intervals for 3 tered as spectinomycin dihydrochloride to 5 consecutive days. pentahydrate as follows: (2) Indications for use. For the treat- (1) Subcutaneously in the treatment ment of bovine respiratory disease of 1-to-3-day-old turkey poults at the (pneumonia) associated with rate of 1 to 2 milligrams per poult as an Mannheimia haemolytica, Pasteurella aid in the prevention of mortality asso- multocida, and Histophilus somni. ciated with Arizona group infection. (3) Limitations. Do not slaughter with- (2) Subcutaneously in the treatment in 11 days of last treatment. Do not use of 1-to-3-day old: in female dairy cattle 20 months of age (i) Turkey poults at the rate of 5 mil- or older. Use in this class of cattle may ligrams per poult as an aid in the con- cause residues in milk. A withdrawal trol of chronic respiratory disease period has not been established for this (CRD) associated with E. coli. product in preruminating calves. Do (ii) Baby chicks at the rate of 2.5 to not use in calves to be processed for 5 milligrams per chick as an aid in the veal. Federal law restricts this drug to control of mortality and to lessen se- use by or on the order of a licensed vet- verity of infections caused by M. erinarian. synoviae, S. typhimurium, S. infantis, [72 FR 31178, June 6, 2007, as amended at 79 and E. coli. FR 16195, Mar. 25, 2014] (3) Intramuscularly in the treatment of dogs: § 522.2150 Stanozolol. (i) At a dosage level of 2.5 milligrams (a) Specifications. Each milliliter of to 5.0 milligrams per pound of body suspension contains 50 milligrams (mg) weight twice daily. Treatment may be of stanozolol. continued for 4 days. For treatment of (b) Sponsor. No. 054771 in § 510.600(c) of infections caused by gram-negative and this chapter. gram-positive organisms susceptible to (c) Conditions of use—(1) Amount—(i) spectinomycin. Dogs and cats. For cats and small (ii) Federal law restricts this drug to breeds of dogs: 25 mg. For larger dogs: use by or on the order of a licensed vet- 50 mg. Administer by deep erinarian. intramuscular injection in the thigh at (4) Administer single injection of 0.1 weekly intervals, for several weeks. milliliter (10 milligrams) (ii) Horses. Administer 25 mg per 100 subcutaneously in nape of neck of 1- to pounds of body weight by deep 3-day-old turkey poults as an aid in intramuscular injection in the gluteal control of airsacculitis associated with region at weekly intervals, for not M. meleagridis sensitive to more than 4 weeks. spectinomycin. (2) Indications for use. For use as an [40 FR 13858, Mar. 27, 1975, as amended at 43 anabolic steroid treatment. FR 9273, Mar. 7, 1978; 46 FR 18964, Mar. 27, (3) Limitations. Do not use in horses 1981; 47 FR 14149, Apr. 2, 1982; 61 FR 5507, Feb. intended for human consumption. Fed- 13, 1996; 61 FR 31028, June 19, 1996; 65 FR eral law restricts this drug to use by or 45877, July 26, 2000; 66 FR 22118, May 3, 2001; on the order of a licensed veterinarian. 79 FR 16195, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; 84 FR 32992, July 11, 2019] [79 FR 16195, Mar. 25, 2014]

§ 522.2121 Spectinomycin sulfate. § 522.2200 Sulfachlorpyridazine. (a) Specifications. Each milliliter of (a) Specifications. Each milliliter of solution contains spectinomycin sul- solution contains sodium

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sulfachlorpyridazine equivalent to 200 (iii) Limitations. Federal law restricts milligrams (mg) sulfachlorpyridazine. this drug to use by or on the order of a (b) Sponsor. See No. 000010 in licensed veterinarian. § 510.600(c) of this chapter. (2) Dogs and cats—(i) Amount. Admin- (c) Related tolerances. See § 556.630 of ister by intravenous or subcutaneous this chapter. injection at an initial dose of 55 mg per (d) Conditions of use in calves. It is kilogram of body weight followed by used as follows: 27.5 mg per kilogram of body weight (1) Amount. Administer 30 to 45 mg every 24 hours. per pound (/lb) of body weight in di- (ii) Indications for use. For the treat- vided doses by twice daily injection for ment of respiratory, genitourinary 1 to 5 days. tract, enteric, and soft tissue infec- (2) Indications for use. For the treat- tions when caused by Streptococci, ment of diarrhea caused or complicated Staphylococci, Escherichia, Salmonella, by Escherichia coli (colibacillosis). Klebsiella, Proteus, or Shigella orga- (3) Limitations. Treated calves must nisms sensitive to sulfadimethoxine, not be slaughtered for food during and in the treatment of canine bac- treatment or for 5 days after the last terial enteritis associated with coccidi- treatment. A withdrawal period has osis and canine Salmonellosis. not been established 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. [75 FR 10167, Mar. 5, 2010] (3) Horses—(i) Amount. Administer by intravenous injection at an initial dose § 522.2220 Sulfadimethoxine. of 55 mg per kilogram of body weight (a) Specifications. Each milliliter of followed by 27.5 mg per kilogram of solution contains: body weight every 24 hours until the (1) 100 milligrams (mg) of patient is asymptomatic for 48 hours. sulfadimethoxine sodium. (ii) Indications for use. For the treat- (2) 400 mg of sulfadimethoxine so- ment of respiratory disease caused by dium. Streptococcus equi (strangles). (b) Sponsors. See sponsor numbers in (iii) Limitations. Do not use in horses § 510.600(c) of this chapter for use as in intended for human consumption. Fed- paragraph (d) of this section. eral law restricts this drug to use by or (1) No. 069043 for use of the product on the order of a licensed veterinarian. described in paragraph (a)(1) as in para- (4) Cattle—(i) Amount. Administer an graph (d)(1) of this section. initial dose of 25 mg per pound of body (2) No. 054771 for use of the product weight by intravenous injection fol- described in paragraph (a)(2) as in para- lowed by 12.5 mg per pound of body graphs (d)(2), (3), and (4) of this section. weight every 24 hours until the animal (3) Nos. 016592 and 061133 for use of is asymptomatic for 48 hours. the product described in paragraph (ii) Indications for use. For the treat- (a)(2) as in paragraph (d)(4) of this sec- ment of bovine respiratory disease tion. complex (shipping fever complex) and (c) Related tolerances. See § 556.640 of bacterial pneumonia associated with this chapter. Pasteurella spp. sensitive to (d) Conditions of use—(1) Dogs—(i) sulfadimethoxine; necrotic Amount. Administer by subcutaneous, pododermatitis (foot rot) and calf diph- intramuscular, or intravenous injec- theria caused by Fusobacterium tion at an initial dose of 25 mg per necrophorum sensitive to 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

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preruminating calves. Do not use in (shipping fever complex) (Pasteurella calves to be processed for veal. spp.), colibacillosis (bacterial scours) [79 FR 16196, Mar. 25, 2014, as amended at 81 (Escherichia coli), necrotic FR 22524, Apr. 18, 2016; 83 FR 48946, Sept. 28, pododermatitis (foot rot) 2018; 84 FR 8974, Mar. 13, 2019] (Fusobacterium necrophorum), calf diphtheria (Fusobacterium necrophorum), § 522.2240 Sulfaethoxypyridazine. acute mastitis and acute metritis (a) Specifications. The drug is an aque- (Streptococcus spp.) when caused by one ous solution of sulfaethoxypyridazine. or more pathogenic organisms sen- (b) Sponsor. See No. 054771 in sitive to sulfamethazine. § 510.600(c) of this chapter. (3) Limitations. Withdraw medication (c) Related tolerances. See § 556.650 of from cattle 10 days prior to slaughter. this chapter. Do not use in female dairy cattle 20 (d) Conditions of use in cattle—(1) months of age or older. Federal law re- Amount. Administer 2.5 grams per 100 stricts this drug to use by or on the pounds of body weight per day by in- order of a licensed veterinarian. travenous injection for not more than 4 days; or first treatment may be fol- [46 FR 62055, Dec. 22, 1981, as amended at 67 lowed by 3 days of treatment with FR 78355, Dec. 24, 2002; 75 FR 10167, Mar. 5, sulfaethoxypyridazine in drinking 2010; 76 FR 53051, Aug. 25, 2011; 81 FR 17608, water or tablets in accordance with Mar. 30, 2016] §§ 520.2240a(e) and 520.2240b(e) of this chapter. § 522.2340 Sulfomyxin. (2) Indications for use. For treatment (a) Specifications. Sulfomyxin for in- of respiratory infection (pneumonia, jection is sterile. It is derived from the shipping fever), foot rot, calf scours; as antibiotic substance produced by the adjunctive therapy in septicemia ac- growth of Bacillus polymyxa or is the companying mastitis and metritis. same substance produced by any other (3) Limitations. Do not treat within 16 means. days of slaughter. Milk that has been (b) Sponsor. See No. 054771 in taken from animals during treatment § 510.600(c) of this chapter. and for 72 hours (6 milkings) after the (c) Special considerations. The quan- latest treatment must not be used for tities of antibiotic in paragraph (e) of food. Federal law restricts this drug to this section refer to the activity of the use by or on the order of a licensed vet- appropriate standard. erinarian. (d) Related tolerances. See § 556.700 of [79 FR 16196, Mar. 25, 2014] this chapter. (e) Conditions of use. (1) It is used or § 522.2260 Sulfamethazine. intended for use in chickens and tur- (a) Specifications. Each milliliter keys as an aid in the treatment of dis- (mL) of solution contains 250 milli- ease caused or complicated by E. coli, grams (mg) sulfamethazine sodium. such as colibacillosis and complicated (b) Sponsor. See No. 016592 in chronic respiratory disease. § 510.600(c) of this chapter. (2) It is administered by subcuta- (c) Related tolerances. See § 556.670 of neous injection as follows: this chapter. (d) Conditions of use in cattle—(1) Antibiotic activity Amount. Initially administer 20 mL for Age of birds in days Chickens Turkeys each 50 pounds (lb) of body weight (100 (units) (units) mg/lb) by intravenous injection, followed by 20 mL per 100 lb of body 1 to 14 ...... 12,500 12,500 weight (50 mg/lb) by intravenous injec- 15 to 28 ...... 25,000 25,000 29 to 63 ...... 50,000 50,000 tion, daily thereafter. Treatment Over 63 ...... 50,000 100,000 should not exceed a total of 5 consecutive days. (3) A second injection may be given 3 (2) Indications for use. For cattle for days later if symptoms persist. treatment of bacterial pneumonia and bovine respiratory disease complex

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(4) Not for use in laying hens; do not (b) Sponsors. See Nos. 054771 and treat chickens within 5 days of slaugh- 069043 in § 510.600(c) of this chapter. ter; do not treat turkeys within 7 days (c) Conditions of use—(1) Amount. Ad- of slaughter. minister by intravenous injection to ef- [40 FR 13858, Mar. 27, 1975, as amended at 79 fect. The average single dose is: FR 16196, Mar. 25, 2014] (i) Dogs and cats: 8 milligrams (mg) per pound of body weight (when used § 522.2404 Thialbarbitone sodium for with a preanesthetic, generally one- injection. half the normal dose). (a) Specifications. Thialbarbitone so- (ii) Swine: 40 mg per 5 pounds (lbs) of dium for injection when reconstituted body weight. with sterile distilled water provides 94 (iii) Horses: Light anesthesia, 1 gram milligrams of thialbarbitone sodium per 500 lbs to 1,100 lbs of body weight; per milliliter of solution. deep anethesia, 1 gram per 300 lbs of (b) Sponsor. See No. 054771 in body weight (40 mg/12 lbs of body § 510.600(c) of this chapter. weight). (c) Conditions of use. (1) The drug is (iv) Cattle: Short duration, 20 mg/5 lbs administered as a general anesthetic in of body weight; longer duration, 40 mg/ surgical procedures on dogs, cats, 7 lbs of body weight. swine, sheep, cattle, and horses. The drug is used for procedures of rel- (2) Indications for use. It is used as an atively short duration. However, the ultra-short-acting anesthetic in dogs, period of anesthesia can be lengthened cats, swine, horses, and cattle. by slower initial injection and supple- (3) Limitations. Do not use in horses mental administration during surgery. intended for human consumption. Fed- (2) It is administered intravenously. eral law restricts this drug to use by or The drug is injected slowly to dogs, on the order of a licensed veterinarian. cats, cattle, sheep, and swine. For [79 FR 16196, Mar. 25, 2014, as amended at 83 horses, it is recommended that a pre- FR 48946, Sept. 28, 2018] anesthetic sedation be administered to the horse 30 minutes before the drug is § 522.2444 Thiopental injectable dos- administered. The drug is then injected age forms. rapidly and completely. The drug is used at the following dosage levels: § 522.2444a Thiopental powder for injection. Weight of animal Dosage in Species in pounds milligrams (a) Specifications. The drug contains per pound sodium thiopental powder for constitu- Dog ...... Over 50 ...... 14.1 tion with sterile water for injection. Do ...... 30–50 ...... 18.8 (b) Sponsor. See No. 054771 in Do ...... 10–30 ...... 23.5 Do ...... Under 10 ...... 28.2 § 510.600(c) of this chapter. Cat ...... 31.3–37.6 (c) Conditions of use in dogs and cats— Horse ...... 6.3–7.8 (1) Amount. Administer by intravenous Cattle and swine ...... 6.7–9.4 Calves and sheep ...... 9.4–11.8 injection as follows: (i) 6 to 9 milligrams (mg) per pound (3) Federal law restricts this drug to of body weight for brief anesthesia (6 to use by or on the order of a licensed vet- 10 minutes). erinarian. (ii) 10 to 12 mg per pound of body [40 FR 13858, Mar. 27, 1975, as amended at 79 weight for anesthesia of 15 to 25 min- FR 16196, Mar. 25, 2014] utes duration. (2) Indications for use. It is used as an § 522.2424 Thiamylal. anesthetic for intravenous administra- (a) Specifications. The drug is a sterile tion to dogs and cats during short to powder. It is reconstituted with sterile moderately long surgical and other distilled water, water for injection, or procedures. It is also used to induce an- sodium chloride injection, to a desired esthesia in dogs and cats which then concentration of 0.5 to 4 percent so- have surgical anesthesia maintained by dium thiamylal. use of a volatile anesthetic.

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(3) Limitations. Federal law restricts (iii) Limitations. Cattle intended for this drug to use by or on the order of a human consumption must not be licensed veterinarian. slaughtered within 21 days from the [79 FR 16196, Mar. 25, 2014] last treatment. Do not use in female dairy cattle 20 months of age or older. § 522.2444b Thiopental and pento- A withdrawal period has not been es- barbital powder for injection. tablished for this product in (a) Specifications. Each gram of pow- preruminating calves. Do not use in der contains 750 milligrams (mg) of so- calves to be processed for veal. Federal dium thiopental and 250 mg of sodium law restricts this drug to use by or on pentobarbital powder for dilution with the order of a licensed veterinarian. sterile water for injection. (2) [Reserved] (b) Sponsor. See No. 061133 in [77 FR 39391, July 3, 2012] § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. For § 522.2470 Tiletamine and zolazepam total anesthesia, it is given at approxi- for injection. mately 10 to 12 mg per pound of body (a) Specifications. The drug is a sterile weight over a period of 3.5 to 5 min- powder. Each milliliter of constituted utes. When preanesthetic medication is solution contains tiletamine hydro- used, wait at least an hour before ad- chloride equivalent to 50 milligrams ministering thiopental and sodium pentobarbital for injection, and the dosage (mg) of tiletamine base and zolazepam necessary for anesthesia is reduced. hydrochloride equivalent to 50 mg of zolazepam base. Usually 1⁄2 to 2⁄3 the normal amount is adequate. (b) Sponsors. See sponsors in (2) Indications for use. It is used as an § 510.600(c) of this chapter: anesthetic for intravenous administra- (1) No. 054771 for use as in paragraph tion to dogs and cats during short to (c) of this section. moderately long surgical procedures. (2) Nos. 026637 and 051311 for use as in (3) Limitations. Federal law restricts paragraphs (c)(1)(i)(A), (c)(1)(ii)(A), this drug to use by or on the order of a (c)(1)(iii) and (c)(2) of this section. licensed veterinarian. (c) Conditions of use—(1) Dogs—(i) Amount. Expressed as milligrams of the [79 FR 16197, Mar. 25, 2014, as amended at 84 FR 8974, Mar. 13, 2019] drug combination: (A) An initial intramuscular dosage § 522.2460 Tildipirosin. of 3 to 4.5 milligrams per pound (mg/lb) (a) Specifications. Each milliliter of of body weight for diagnostic purposes; solution contains: 4.5 to 6 mg/lb of body weight for minor (1) 180 milligrams (mg) tildipirosin. procedures of short duration such as (2) [Reserved] repair of lacerations and wounds, cas- (b) Sponsor. See No. 000061 in trations, and other procedures requir- § 510.600(c) of this chapter. ing mild to moderate analgesia. Sup- (c) Related tolerances. See § 556.733 of plemental doses when required should this chapter. be less than the initial dose and the (d) Conditions of use—(1) Cattle—(i) total dose given should not exceed 12 Amount. Administer 4 mg/kg of body- mg/lb of body weight. The maximum weight one time by subcutaneous injec- total safe dose is 13.6 mg/lb of body tion in the neck. weight. (ii) Indications for use. For the treat- (B) Administer intravenously at 1 to ment of bovine respiratory disease 2 mg/lb (2.2 to 4.4 mg/kg) body weight (BRD) associated with Mannheimia to effect for induction of anesthesia haemolytica, Pasteurella multocida, and followed by maintenance with an inhal- Histophilus somni in beef and non-lac- ant anesthetic. tating dairy cattle; and for the control (ii) Indications for use. (A) of respiratory disease in beef and non- Intramuscular administration in dogs lactating dairy cattle at high risk of for restraint and minor procedures of developing BRD associated with M. short duration (30 minutes average) re- haemolytica, P. multocida, and H. somni. quiring mild to moderate analgesia.

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(B) Intravenous administration in (BRD) associated with Mannheimia dogs for induction of anesthesia fol- haemolytica, Pasteurella multocida, and lowed by maintenance with an inhalant Histophilus somni. For the control of anesthetic. respiratory disease in cattle at high (iii) Limitations. Federal law restricts risk of developing BRD associated with this drug to use by or on the order of a M. haemolytica. licensed veterinarian. (iii) Limitations. Do not use in female (2) Cats—(i) Amount. An initial dairy cattle 20 months of age or older. intramuscular dosage of 4.4 to 5.4 mg/lb Use of this antibiotic in this class of of body weight is recommended for cattle may cause milk residues. Do not such procedures as dentistry, treat- slaughter within 42 days of last treatment of abscesses, foreign body re- ment. moval, and related types of surgery; 4.8 (2) Sheep—(i) Amount. 10 mg/kg body to 5.7 mg/lb of body weight for minor weight as a single subcutaneous injec- procedures requiring mild to moderate tion. analgesia, such as repair of lacerations, (ii) Indications for use. For the treat- castrations, and other procedures of ment of ovine respiratory disease short duration. Initial dosages of 6.5 to (ORD) associated with Mannheimia (P.) 7.2 mg/lb of body weight are rec- haemolytica. ommended for ovariohysterectomy and (iii) Limitations. Do not slaughter onychectomy. When supplemental within 28 days of last treatment. doses are required, such individual supplemental doses should be given in in- [67 FR 72367, Dec. 5, 2002, as amended at 75 crements that are less than the initial FR 9334, Mar. 2, 2010; 81 FR 48703, July 26, dose and the total dose given (initial 2016] dose plus supplemental doses) should § 522.2473 Tiludronate. not exceed the maximum allowable safe dose of 32.7 mg/lb of body weight. (a) Specifications. Each vial of powder (ii) Indications for use. For restraint contains 500 milligrams (mg) or for anesthesia combined with muscle tiludronate disodium. Each milliliter relaxation. of constituted solution contains 20 mg (iii) Limitations. Federal law restricts tiludronate disodium. this drug to use by or on the order of a (b) Sponsor. See No. 061133 in licensed veterinarian. § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) [79 FR 16197, Mar. 25, 2014, as amended at 83 Amount. Administer a single dose of 1 FR 14587, Apr. 5, 2018] mg per kilogram (0.45 mg/pound) of § 522.2471 Tilmicosin. body weight by intravenous infusion. (2) Indication for use. For the control (a) Specifications. Each milliliter of of clinical signs associated with navic- solution contains 300 milligrams (mg) ular syndrome. tilmicosin base as tilmicosin phos- (3) Limitations. Do not use in horses phate. intended for human consumption. Fed- (b) Sponsor. See No. 058198 in eral law restricts this drug to use by or § 510.600(c) of this chapter. on the order of a licensed veterinarian. (c) Related tolerances. See § 556.735 of this chapter. [79 FR 18159, Apr. 1, 2014, as amended at 82 (d) Special considerations. (1) Not for FR 21691, May 10, 2017; 84 FR 8974, Mar. 13, human use. Use of this antibiotic in 2019] humans may prove fatal. Do not use in automatically powered syringes. § 522.2474 Tolazoline. (2) Federal law restricts this drug to (a) Specifications. Each milliliter of use by or on the order of a licensed vet- solution contains tolazoline hydro- erinarian. chloride equivalent to 100 milligrams (e) Conditions of use—(1) Cattle—(i) (mg) of base activity. Amount. 10 to 20 milligrams per kilo- (b) Sponsor. See No. 059399 in grams (mg/kg) of body weight as a sin- § 510.600(c) of this chapter. gle subcutaneous injection. (c) Conditions of use in horses—(1) (ii) Indications for use. For the treat- Amount. Administer slowly by intra- ment of bovine respiratory disease venous injection 4 mg per kilogram of

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body weight or 1.8 mg per pound (4 mil- pellet containing 20 mg trenbolone ace- liliters (mL) per 100 kilograms or 4 mL tate) per implant dose. per 220 pounds). (B) 200 mg of trenbolone acetate (one (2) Indications for use. For use in implant consisting of 11 pellets, each of horses when it is desirable to reverse 10 pellets containing 20 mg of the effects of sedation and analgesia trenbolone acetate, and 1 pellet con- caused by xylazine. taining 29 mg of tylosin tartrate) per (3) Limitations. Do not use in horses implant dose. intended for human consumption. Fed- (ii) Indications for use. For increased eral law restricts this drug to use by or rate of weight gain and improved feed on the order of a licensed veterinarian. efficiency. (iii) Limitations. Implant [79 FR 16197, Mar. 25, 2014, as amended at 79 subcutaneously in ear only. Do not use FR 74020, Dec. 15, 2014; 80 FR 13230, Mar. 13, in animals intended for subsequent 2015] breeding or in dairy animals. Safety § 522.2476 Trenbolone acetate. and effectiveness have not been established in veal calves. A withdrawal pe- (a) Sponsors. See sponsors in riod has not been established for this § 510.600(c) of this chapter for use as in product in preruminating calves. Do paragraph (d) of this section. not use in calves to be processed for (1) No. 058198 for use as in paragraph veal. (c) of this section. (2) No. 000061 for use as in paragraphs [66 FR 47961, Sept. 17, 2001, as amended at 69 (c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), FR 70056, Dec. 2, 2004; 74 FR 61517, Nov. 25, 2009; 81 FR 48703, July 26, 2016] (c)(2)(i)(A), (c)(2)(ii), and (c)(2)(iii) of this section. § 522.2477 Trenbolone acetate and es- (b) Related tolerances. See § 556.739 of tradiol. this chapter. (a) [Reserved] (c) Conditions of use—(1) Steers fed in (b) Sponsors. See sponsors in confinement for slaughter—(i) Amount. § 510.600(c) of this chapter for uses as in Use 126 days prior to slaughter; should paragraph (d) of this section. be reimplanted once after 63 days. (1) No. 058198 for use as in paragraphs (A) 140 milligrams (mg) trenbolone (d)(1)(i)(A), (d)(1)(i)(B), (d)(1)(i)(C), acetate (one implant consisting of 7 (d)(1)(i)(D), (d)(1)(i)(E), (d)(1)(i)(F), pellets, each pellet containing 20 mg (d)(1)(ii), (d)(1)(iii), (d)(2), and (d)(3) of trenbolone acetate) per implant dose. this section. (B) 140 mg trenbolone acetate (one (2) No. 000061 for use as in paragraphs implant consisting of 8 pellets, each of (d)(1)(i)(A), (d)(1)(i)(C), (d)(1)(i)(D), 7 pellets containing 20 milligrams (d)(1)(i)(G), (d)(1)(ii), (d)(1)(iii), trenbolone acetate, and 1 pellet con- (d)(2)(i)(A), (d)(2)(i)(C), (d)(2)(i)(D), taining 29 mg tylosin tartrate) per im- (d)(2)(ii), (d)(2)(iii), (d)(3)(i)(A), plant dose. (d)(3)(ii), (d)(3)(iii), (d)(4), and (d)(5) of (ii) Indications for use. For improved this section. feed efficiency. (3) No. 054771 for use as in paragraphs (iii) Limitations. Implant (d)(1)(i)(A), (d)(1)(i)(D), (d)(1)(ii), subcutaneously in ear only. Do not use (d)(1)(iii), (d)(3)(i)(A), (d)(3)(ii), and in animals intended for subsequent (d)(3)(iii) of this section. breeding or in dairy animals. Safety (c) Related tolerances. See §§ 556.240 and effectiveness have not been estab- and 556.739 of this chapter. lished in veal calves. A withdrawal pe- (d) Conditions of use—(1) Steers fed in riod has not been established for this confinement for slaughter—(i) Amount. product in preruminating calves. Do (A) 120 milligrams (mg) trenbolone ace- not use in calves to be processed for tate and 24 mg estradiol (one implant veal. consisting of 6 pellets, each pellet con- (2) Heifers fed in confinement for taining 20 mg trenbolone acetate and 4 slaughter—(i) Amount. Use last 63 days mg estradiol) per implant dose. prior to slaughter. (B) 120 mg trenbolone acetate and 24 (A) 200 mg trenbolone acetate (one mg estradiol (one implant consisting of implant consisting of 10 pellets, each 7 pellets, each of 6 pellets containing 20

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mg trenbolone acetate and 4 mg estra- (C) 80 mg trenbolone acetate and 8 diol, and 1 pellet containing 29 mg mg estradiol (one implant consisting of tylosin tartrate) per implant dose. 4 pellets, each pellet containing 20 mg (C) 200 mg trenbolone acetate and 20 trenbolone acetate and 2 mg estradiol) mg estradiol (one implant consisting of per implant dose for use as in para- 10 pellets, each pellet containing 20 mg graph (d)(2)(ii)(B) of this section. trenbolone acetate and 2 mg estradiol) (D) 200 mg trenbolone acetate and 20 per implant dose. mg estradiol (one implant consisting of (D) 80 mg trenbolone acetate and 16 10 pellets, each pellet containing 20 mg mg estradiol (one implant consisting of trenbolone acetate and 2 mg estradiol) 4 pellets, each pellet containing 20 mg per implant dose for use as in para- trenbolone acetate and 4 mg estradiol) graph (d)(2)(ii)(A) of this section. per implant dose. (E) 80 mg trenbolone acetate and 8 (E) 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of mg estradiol (one implant consisting of 5 pellets, each of 4 pellets containing 20 11 pellets, each of 10 pellets containing mg trenbolone acetate and 2 mg 20 mg trenbolone acetate and 2 mg es- estradiol, and 1 pellet containing 29 mg tradiol, and 1 pellet containing 29 mg tylosin tartrate) per implant dose for tylosin tartrate) per implant dose. use as in paragraph (d)(2)(ii)(B) of this (F) 80 mg trenbolone acetate and 16 section. mg estradiol (one implant consisting of (F) 200 mg trenbolone acetate and 20 5 pellets, each of 4 pellets containing 20 mg estradiol (one implant consisting of mg trenbolone acetate and 4 mg estra- 11 pellets, each of 10 pellets containing diol, and 1 pellet containing 29 mg 20 mg trenbolone acetate and 2 mg es- tylosin tartrate) per implant dose. tradiol, and 1 pellet containing 29 mg (G) 200 milligram (mg) trenbolone ac- tylosin tartrate) per implant dose. etate and 40 mg estradiol (one implant (ii) Indications for use. (A) For in- consisting of 10 pellets, each pellet con- creased rate of weight gain and im- taining 20 mg trenbolone acetate and 4 proved feed efficiency. mg estradiol) per implant dose. (B) For increased rate of weight gain. (ii) Indications for use. For increased (iii) Limitations. Administer implant rate of weight gain and improved feed subcutaneously in the ear only. Do not efficiency. use in animals intended for subsequent (iii) Limitations. Administer implant breeding or in dairy animals. Safety subcutaneously in the ear only. Do not and effectiveness have not been estab- use in animals intended for subsequent lished in veal calves. A withdrawal pe- breeding or in dairy animals. Safety riod has not been established for this and effectiveness have not been estab- product in preruminating calves. Do lished in veal calves. A withdrawal pe- not use in calves to be processed for riod has not been established for this veal. product in preruminating calves. Do (3) Pasture cattle (slaughter, stocker, not use in calves to be processed for and feeder steers and heifers)—(i) veal. Amount. (A) 40 mg trenbolone acetate (2) Heifers fed in confinement for and 8 mg estradiol (one implant con- slaughter—(i) Amount. (A) 140 mg sisting of 2 pellets, each pellet con- trenbolone acetate and 14 mg estradiol taining 20 mg trenbolone acetate and 4 (one implant consisting of 7 pellets, mg estradiol) per implant dose. each pellet containing 20 mg (B) 40 mg trenbolone acetate and 8 trenbolone acetate and 2 mg estradiol) mg estradiol (one implant consisting of per implant dose for use as in para- 3 pellets, each of 2 pellets containing 20 graph (d)(2)(ii)(A) of this section. mg trenbolone acetate and 4 mg estra- (B) 140 mg trenbolone acetate and 14 diol, and 1 pellet containing 29 mg mg estradiol (one implant consisting of tylosin tartrate) per implant dose. 8 pellets, each of 7 pellets containing 20 (ii) Indications for use. For increased mg trenbolone acetate and 2 mg estra- rate of weight gain. diol, and 1 pellet containing 29 mg (iii) Limitations. Administer implant tylosin tartrate) per implant dose for subcutaneously in the ear only. Do not use as in paragraphs (d)(2)(ii)(A) of this use in animals intended for subsequent section. breeding or in dairy animals. Safety

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and effectiveness have not been estab- has not been established for this prod- lished in veal calves. A withdrawal pe- uct in pre-ruminating calves. Effective- riod has not been established for this ness and animal safety in veal calves product in preruminating calves. Do have not been established. Not ap- not use in calves to be processed for proved for repeated implantation (reveal. implantation) with this or any other (4) Beef steers and heifers fed in con- cattle ear implant during the produc- finement for slaughter—(i) Amount. Each tion phase(s) identified on labeling extended- and delayed-release implant (beef heifers fed in confinement for contains 200 mg trenbolone acetate and slaughter) unless otherwise indicated 20 mg estradiol (one implant consisting on labeling because safety and effec- of 10 pellets, each pellet containing 20 tiveness have not been evaluated. mg trenbolone acetate and 2 mg estra- [60 FR 4376, Jan. 23, 1995] diol) per implant dose. (ii) Indications for use. For increased EDITORIAL NOTE: For FEDERAL REGISTER ci- rate of weight gain and improved feed tations affecting § 522.2477, see the List of CFR Sections Affected, which appears in the efficiency during 70 to 200 days after Finding Aids section of the printed volume implantation. and at www.govinfo.gov. (iii) Limitations. Administer implant subcutaneously in the ear only. Do not § 522.2478 Trenbolone acetate and es- use in lactating dairy cows or in ani- tradiol benzoate. mals intended for subsequent breeding. (a) Specifications. (1) Each implant Use in these cattle may cause drug res- consists of: idues in milk and/or in calves born to (i) 8 pellets, each pellet containing 25 these cows. Do not use in calves to be milligrams (mg) trenbolone acetate processed for veal. A withdrawal period and 3.5 mg estradiol benzoate. has not been established for this prod- (ii) 4 pellets, each pellet containing uct in pre-ruminating calves. Effective- 25 mg trenbolone acetate and 3.5 mg es- ness and animal safety in veal calves tradiol benzoate. have not been established. Not ap- (2) Each extended release implant proved for repeated implantation (re- consists of: implantation) with this or any other (i) 8 pellets with a porous polymer cattle ear implant during the produc- film coating, each pellet containing 25 tion phase(s) identified on labeling mg trenbolone acetate and 3.5 mg es- (beef steers and heifers fed in confine- tradiol benzoate. ment for slaughter) unless otherwise (ii) 6 pellets with a porous polymer indicated on labeling because safety film coating, each pellet containing 25 and effectiveness have not been evalu- mg trenbolone acetate and 3.5 mg es- ated. tradiol benzoate. (5) Beef heifers fed in confinement for (b) Sponsor. See No. 054771 in slaughter—(i) Amount. Each extended- § 510.600(c) of this chapter. release implant contains 200 mg (c) Related tolerances. See §§ 556.240 trenbolone acetate and 20 mg estradiol and 556.739 of this chapter. (one implant consisting of 6 coated and (d) Conditions of use—(1) Steers fed in 4 uncoated pellets, each pellet con- confinement for slaughter. (i) For an im- taining 20 mg trenbolone acetate and 2 plant as described in paragraph (a)(1)(i) mg estradiol). of this section: (ii) Indications for use. For increased (A) Amount. 200 mg trenbolone ace- rate of weight gain and improved feed tate and 28 mg estradiol benzoate. efficiency for up to 200 days after im- (B) Indications for use. For increased plantation. rate of weight gain and improved feed (iii) Limitations. Administer implant efficiency. subcutaneously in the ear only. Do not (C) Limitations. Implant use in lactating dairy cows or in ani- subcutaneously in ear only. Safety and mals intended for subsequent breeding. effectiveness have not been established Use in these cattle may cause drug resin veal calves. A withdrawal period has idues in milk and/or in calves born to not been established for this product in these cows. Do not use in calves to be preruminating calves. Do not use in processed for veal. A withdrawal period calves to be processed for veal.

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(ii) For an implant as described in calves. Do not use in calves to be proc- paragraph (a)(1)(ii) of this section: essed for veal. (A) Amount. 100 mg trenbolone ace- (iii) For an implant as described in tate and 14 mg estradiol benzoate. paragraph (a)(2)(i) of this section: (B) Indications for use. For increased (A) Amount. 200 mg trenbolone ace- rate of weight gain. tate and 28 mg estradiol benzoate in an (C) Limitations. Implant extended release implant. subcutaneously in ear only. Safety and (B) Indications for use. For increased effectiveness have not been established rate of weight gain and improved feed in veal calves. A withdrawal period has efficiency for up to 200 days. not been established for this product in (C) Limitations. Implant preruminating calves. Do not use in subcutaneously in ear only. Not for use calves to be processed for veal. in dairy or beef replacement heifers. (iii) For an implant as described in Safety and effectiveness have not been paragraph (a)(2)(i) of this section: established in veal calves. A with- (A) Amount. 200 mg trenbolone ace- drawal period has not been established tate and 28 mg estradiol benzoate in an for this product in preruminating extended release implant. calves. Do not use in calves to be proc- (B) Indications for use. For increased essed for veal. rate of weight gain and improved feed (3) Pasture steers and heifers (slaugh- efficiency for up to 200 days. ter, stocker, and feeder). (i) For an im- (C) Limitations. Implant plant as described in paragraph subcutaneously in ear only. Safety and (a)(2)(ii) of this section: effectiveness have not been established (A) Amount. 150 mg trenbolone ace- in veal calves. A withdrawal period has tate and 21 mg estradiol benzoate in an not been established for this product in extended release implant. preruminating calves. Do not use in (B) Indications for use. For increased calves to be processed for veal. rate of weight gain for up to 200 days. (2) Heifers fed in confinement for (C) Limitations. Implant slaughter. (i) For an implant as de- subcutaneously in ear only. Not for use scribed in paragraph (a)(1)(i) of this in dairy or beef replacement heifers. section: Safety and effectiveness have not been (A) Amount. 200 mg trenbolone ace- established in veal calves. A with- tate and 28 mg estradiol benzoate. drawal period has not been established (B) Indications for use. For increased for this product in preruminating rate of weight gain. calves. Do not use in calves to be proc- (C) Limitations. Implant essed for veal. subcutaneously in ear only. Not for use (ii) [Reserved] in dairy or beef replacement heifers. Safety and effectiveness have not been [67 FR 78972, Dec. 27, 2002, as amended at 69 established in veal calves. A with- FR 67818, Nov. 22, 2004; 79 FR 16197, Mar. 25, drawal period has not been established 2014; 79 FR 64116, Oct. 28, 2014] for this product in preruminating calves. Do not use in calves to be proc- § 522.2483 Triamcinolone. essed for veal. (a) Specifications. Each milliliter of (ii) For an implant as described in suspension contains 2 or 6 milligrams paragraph (a)(1)(ii) of this section: (mg) triamcinolone acetonide. (A) Amount. 100 mg trenbolone ace- (b) Sponsors. See Nos. 000010 and tate and 14 mg estradiol benzoate. 069043 in § 510.600(c) of this chapter. (B) Indications for use. For increased (c) Conditions of use—(1) Dogs and rate of weight gain and improved feed cats—(i) Amount—(A) Intramuscular or efficiency. subcutaneous. For inflammatory, ar- (C) Limitations. Implant thritic, or allergic disorders, admin- subcutaneously in ear only. Not for use ister 0.05 to 0.1 mg per pound (/lb) of in dairy or beef replacement heifers. body weight as a single injection. For Safety and effectiveness have not been dermatologic disorders, administer 0.1 established in veal calves. A with- mg per pound (/lb) of body weight as a drawal period has not been established single injection. If symptoms recur, the for this product in preruminating dose may be repeated, or oral

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corticosteroid therapy may be insti- (c) Conditions of use—(1) Amount—(i) tuted. Dogs. Administer by intravenous injec- (B) Intralesional. Administer 1.2 to 1.8 tion at a dosage of 0.5 to 1 mg per mg, divided in several injections pound of body weight daily, or by around the lesion, spaced 0.5 to 2.5 cen- intramuscular injection at a dosage of timeters apart, depending on lesion 1 to 2 mg per pound of body weight size. At any one site, the dose injected daily. should not exceed 0.6 mg. and should be (ii) Cats. Administer by well into the cutis to prevent rupture intramuscular injection at a dosage of of the epidermis. When treating ani- 2 to 4 mg per pound of body weight mals with multiple lesions, do not ex- daily. ceed a total dose of 6 mg. (iii) Horses. Administer by intra- (C) Intra-articular and intrasynovial. venous or intramuscular injection at a Administer 1 to 3 mg as a single injec- dosage of 10 to 15 mg per 100 pounds of tion, depending on the size of the joint body weight daily to a maximum dose and severity of symptoms. After 3 or 4 of 100 mg. days, repeat dosage if indicated. If ini- (2) Indications for use. For use in dogs, tial results are inadequate or too tran- cats, and horses to relieve anxiety and sient, dosage may be increased, not to to help control psychomotor over- exceed 3 mg. activity as well as to increase the tol- (ii) Indications for use. For the treat- erance of animals to pain and pruritus. ment of inflammation and related dis- The drug is indicated in various office orders, and the management and treat- and clinical procedures which require ment of acute arthritis and allergic the aid of a tranquilizer, antiemetic, or and dermatologic disorders. preanesthetic. (iii) Limitations. Federal law restricts (3) Limitations. Do not use in horses this drug to use by or on the order of a intended for human consumption. Fed- licensed veterinarian. eral law restricts this drug to use by or (2) Horses—(i) Amount—(A) on the order of a licensed veterinarian. Intramuscular or subcutaneous. Admin- ister 0.01 to 0.02 mg/lb of body weight as [79 FR 16197, Mar. 25, 2014] a single injection. Usual dose is 12 to 20 mg. § 522.2610 Trimethoprim and sulfa- (B) Intra-articular and intrasynovial. diazine. Administer 6 to 18 mg as a single injec- (a) Specifications. Each milliliter tion, depending on the size of the joint (mL) contains: and severity of symptoms. After 3 or 4 (1) 40 milligrams (mg) trimethoprim days, repeat dosage if indicated. If ini- suspended in a solution containing 200 tial results are inadequate or too tran- mg sulfadiazine; or sient, dosage may be increased, not to (2) 80 mg trimethoprim suspended in exceed 18 mg. a solution containing 400 mg sulfa- (ii) Indications for use. For the treat- diazine (as the sodium salt). ment of inflammation and related dis- (b) Sponsors. See Nos. 000061 and orders. 054771 in § 510.600(c) of this chapter. (iii) Limitations. Do not use in horses (c) Conditions of use—(1) Dogs—(i) intended for human consumption. Fed- Amount. 1 mL of the product described eral law restricts this drug to use by or in paragraph (a)(1) of this section (40 on the order of a licensed veterinarian. mg trimethoprim and 200 mg sulfa- [75 FR 10167, Mar. 5, 2010, as amended at 78 diazine) per 20 pounds (9 kilograms) of FR 21060, Apr. 9, 2013; 80 FR 34279, June 16, body weight per day by subcutaneous 2015; 83 FR 48946, Sept. 28, 2018] injection. (ii) Indications for use. For the treat- § 522.2582 Triflupromazine. ment of acute urinary tract infections, (a) Specifications. Each milliliter of acute bacterial complications of dis- solution contains 20 milligrams (mg) of temper, acute respiratory tract infec- triflupromazine hydrochloride. tions, acute alimentary tract infec- (b) Sponsor. See No. 054771 in tions, and acute septicemia due to § 510.600(c) of this chapter. Streptococcus zooepidemicus.

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(iii) Limitations. Federal law restricts (3) Cattle—(i) Amount. Administer 0.5 this drug to use by or on the order of a mg per pound of body weight by intra- licensed veterinarian. venous or intramuscular injection. (2) Horses—(i) Amount. 2 mL of the (ii) Indications for use. For use in product described in paragraph (a)(2) of treating conditions in which antihis- this section (160 mg trimethoprim and taminic therapy may be expected to 800 mg sulfadiazine) per 100 pounds (45 lead to alleviation of some signs of dis- kilograms) of body weight per day by ease. intravenous injection as single, daily (iii) Limitations. Treated cattle must dose for 5 to 7 days. The daily dose may not be slaughtered for food during also be halved and given morning and treatment and for 4 days following the evening. last treatment. Milk that has been (ii) Indications for use. For use where taken during treatment and for 24 systemic antibacterial action against hours (two milkings) after the last sensitive organisms is required during treatment must not be used for food. A treatment of acute strangles, res- withdrawal period has not been estab- piratory tract infections, acute uro- lished for this product in genital infections, and wound infec- preruminating calves. Do not use in tions and abscesses. calves to be processed for veal. Federal (iii) Limitations. Do not use in horses law restricts this drug to use by or on intended for human consumption. Fed- the order of a licensed veterinarian. eral law restricts this drug to use by or [51 FR 44450, Dec. 10, 1986, as amended at 61 on the order of a licensed veterinarian. FR 29480, June 11, 1996; 62 FR 4164, Jan. 29, 1997; 78 FR 17597, Mar. 22, 2013; 79 FR 16198, [71 FR 30803, May 31, 2006, as amended at 79 Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; 82 FR FR 16197, Mar. 25, 2014] 11508, Feb. 24, 2017]

§ 522.2615 Tripelennamine. § 522.2630 Tulathromycin. (a) Specifications. Each milliliter of (a) Specifications. Each milliliter of solution contains 20 milligrams (mg) of solution contains: tripelennamine hydrochloride. (1) 100 milligrams (mg) (b) Sponsors. See Nos. 016592 and tulathromycin 051031 in § 510.600(c) of this chapter. (2) 25 mg tulathromycin (c) Related tolerances. See § 556.741 of (b) Sponsor. See No. 054771 in this chapter. § 510.600(c) of this chapter for use as in (d) Conditions of use—(1) Dogs and paragraph (d) of this section: cats—(i) Amount. Administer 0.5 mg per (1) Product described as in paragraph pound of body weight by intramuscular (a)(1) of this section for use as in para- injection. graphs (d)(1)(i), (d)(1)(ii), (d)(1)(iii)(A), (ii) Indications for use. For use in and (d)(2) of this section. treating conditions in which antihis- (2) Product described as in paragraph taminic therapy may be expected to (a)(2) of this section for use as in para- lead to alleviation of some signs of dis- graphs (d)(1)(i), (d)(1)(ii)(B), ease. (d)(1)(iii)(B), and (d)(2) of this section. (iii) Limitations. Federal law restricts (c) Related tolerances. See § 556.745 of this drug to use by or on the order of a this chapter. licensed veterinarian. (d) Conditions of use—(1) Cattle—(i) (2) Horses—(i) Amount. Administer 0.5 Amount. 2.5 mg per kilogram (/kg) body mg per pound of body weight by weight as a single subcutaneous injec- intramuscular injection. tion in the neck. (ii) Indications for use. For use in (ii) Indications for use—(A) Beef and treating conditions in which antihis- non-lactating dairy cattle. For the treat- taminic therapy may be expected to ment of bovine respiratory disease lead to alleviation of some signs of dis- (BRD) associated with Mannheimia ease. haemolytica, Pasteurella multocida, (iii) Limitations. Do not use in horses Histophilus somni, and Mycoplasma bovis. intended for human consumption. Fed- For the control of respiratory disease eral law restricts this drug to use by or in cattle at high risk of developing on the order of a licensed veterinarian. BRD associated with M. haemolytica, P.

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multocida, H. somni, and M. bovis. For § 522.2640 Tylosin. the treatment of infectious bovine (a) Specifications. Each milliliter keratoconjunctivitis (IBK) associated (mL) of solution contains 50 or 200 mil- with Moraxella bovis. For the treatment ligrams (mg) of tylosin activity (as of bovine foot rot (interdigital tylosin base). necrobacillosis) associated with (b) Sponsors. See sponsors in Fusobacterium necrophorum and § 510.600(c) of this chapter as follows: Porphyromonas levii. (1) No. 000986 for use of 50- or 200-mg/ (B) Suckling calves, dairy calves, and mL solutions as in paragraph (e) of this veal calves. For the treatment of bovine section. respiratory disease (BRD) associated (2) Nos. 000010 and 061133 for use of a with Mannheimia haemolytica, 200-mg/mL solution as in paragraphs Pasteurella multocida, Histophilus somni, (e)(1) and (2) of this section. and Mycoplasma bovis. (c) Related tolerances. See § 556.746 of (iii) Limitations. (A) Cattle intended this chapter. for human consumption must not be (d) Special considerations. Labeling must bear the warning statements: slaughtered within 18 days from the ‘‘Do not administer to horses or other last treatment. This drug is not ap- equines. Injection of tylosin in equines proved for use in female dairy cattle 20 has been fatal.’’ months of age or older, including dry (e) Conditions of use—(1) Beef cattle dairy cows. Use in these cattle may and nonlactating dairy cattle—(i) cause drug residues in milk and/or in Amount. Administer 8 mg per pound calves born to these cows. Federal law (mg/lb) of body weight by restricts this drug to use by or on the intramuscular injection once daily for order of a licensed veterinarian. not more than 5 consecutive days. Con- (B) Calves intended for human continue treatment 24 hours after symp- sumption must not be slaughtered toms disappear. within 22 days from the last treatment. (ii) Indications for use. Treatment of Not for use in ruminating cattle. Fed- bovine respiratory complex (shipping eral law restricts this drug to use by or fever, pneumonia) usually associated on the order of a licensed veterinarian. with Pasteurella multocida and (2) Swine—(i) Amount. 2.5 mg/kg body Arcanobacterium pyogenes; foot rot (ne- weight as a single intramuscular injec- crotic pododermatitis) and calf diph- tion in the neck. theria caused by Fusobacterium (ii) Indications for use. For the treat- necrophorum and metritis caused by A. ment of swine respiratory disease pyogenes. (iii) Limitations. Do not inject more (SRD) associated with Actinobacillus than 10 mL per site. Use a 50-mg/mL so- pleuropneumoniae, P. multocida, lution for calves weighing less than 200 Bordetella bronchiseptica, Haemophilus pounds. Cattle intended for human con- parasuis, and Mycoplasma sumption must not be slaughtered hyopneumoniae; and for the control of within 21 days of the last use of this SRD associated with A. drug product. This drug product is not pleuropneumoniae, P. multocida, and M. approved for use in female dairy cattle hyopneumoniae in groups of pigs where 20 months of age or older, including dry SRD has been diagnosed. dairy cows. Use in these cattle may (iii) Limitations. Swine intended for cause drug residues in milk and/or in human consumption must not be calves born to these cows. This product slaughtered within 5 days from the last is not approved for use in calves in- treatment. Federal law restricts this tended to be processed for veal. A with- drug to use by or on the order of a li- drawal period has not been established censed veterinarian. in preruminating calves. (2) Swine—(i) Amount. Administer 4 [70 FR 39918, July 12, 2005, as amended at 71 FR 57416, Sept. 29, 2006; 72 FR 54540, Sept. 26, mg/lb of body weight by intramuscular 2007; 73 FR 6018, Feb. 1, 2008; 73 FR 58872, Oct. injection twice daily for not more than 8, 2008; 74 FR 53165, Oct. 16, 2009; 78 FR 63872, 3 consecutive days. Continue treatment Oct. 25, 2013; 79 FR 74020, Dec. 15, 2014; 80 FR 24 hours after symptoms disappear. If 13230, Mar. 13, 2015; 81 FR 67151, Sept. 30, 2016] tylosin medicated drinking water is

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used as a followup treatment for swine (1) No. 069043 for use of product de- dysentery, the animal should there- scribed in paragraph (a)(2) of this sec- after receive feed containing 40 to 100 tion as in paragraph (d)(2) of this sec- grams of tylosin per ton for 2 weeks to tion. assure depletion of tissue residues. (2) Nos. 000010 and 061133 for use of (ii) Indications for use. Treatment of product described in paragraph (a)(2) of swine arthritis caused by Mycoplasma this section as in paragraphs (d)(2), hyosynoviae; swine pneumonia caused (d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of by Pasteurella spp.; swine erysipelas this section. caused by Erysipelothrix rhusiopathiae; (3) Nos. 000859 and 061651 for use of swine dysentery associated with product described in paragraph (a)(1) of Treponema hyodysenteriae when fol- this section as in paragraph (d)(1); and lowed by appropriate medication in the product described in paragraph (a)(2) of drinking water and/or feed. this section as in paragraphs (d)(2), (iii) Limitations. Do not inject more (d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of than 5 mL per site. Adverse reactions, this section. including shock and death may result (4) No. 059399 for use of product de- from overdosage in baby pigs. It is rec- scribed in paragraph (a)(1) of this sec- ommended that tylosin 50-mg/mL in- tion as in paragraph (d)(1) of this sec- jection be used in pigs weighing less tion; product described in paragraph than 25 lbs. Swine intended for human (a)(2) of this section as in paragraphs consumption must not be slaughtered (d)(2), (d)(3)(i), (d)(3)(ii)(A), and within 14 days of the last use of this (d)(3)(iii) of this section; and product drug product. described in paragraph (a)(3) of this (3) Dogs and cats—(i) Amount. Admin- section as in paragraphs (d)(3)(i), ister 3 to 5 mg/lb of body weight by (d)(3)(ii)(B), and (d)(3)(iii) of this sec- intramuscular injection at 12- to 24- tion. hour intervals. (c) Special considerations. Federal law (ii) Indications for use—(A) Dogs. restricts this drug to use by or on the Treatment of upper respiratory infec- order of a licensed veterinarian. tions such as bronchitis, (d) Conditions of use—(1) Dogs and tracheobronchitis, tracheitis, laryn- cats—(i) Amount. 0.5 mg/pound (lb) in- gitis, tonsillitis, and pneumonia caused travenously or 1.0 mg/lb by Staphylococci spp., hemolytic subcutaneously. Streptococci spp., and Pasteurella multocida. (ii) Indications for use. To produce se- (B) Cats. Treatment of upper res- dation, as an analgesic, and as a piratory infections when caused by preanesthetic to local or general anes- Staphylococci spp. and hemolytic thesia. Streptococci spp. and for feline pneumo- (2) Horses—(i) Amount. 0.5 mg/lb intra- nitis when caused by tylosin-suscep- venously or 1.0 mg/lb intramuscularly. tible organisms. (ii) Indications for use. To produce se- (iii) Limitations. Federal law restricts dation, as an analgesic, and as a this drug to use by or on the order of a preanesthetic to local or general anes- licensed veterinarian. thesia. (iii) Limitations. Do not use in horses [81 FR 67151, Sept. 30, 2016, as amended at 84 intended for human consumption. FR 8974, Mar. 13, 2019; 84 FR 32992, July 11, 2019] (3) Elk and deer—(i) Amount. Admin- ister intramuscularly, by hand syringe, § 522.2662 Xylazine. or by syringe dart, in the heavy mus- (a) Specifications. Each milliliter cles of the croup or shoulder as follows: (mL) of solution contains xylazine hy- (A) Elk (Cervus canadensis): 0.25 to 0.5 drochloride equivalent to: mg/lb. (1) 20 milligrams (mg) xylazine. (B) Mule deer (Odocoileus hemionus), (2) 100 mg xylazine. sika deer (Cervus nippon), and white- (3) 300 mg xylazine. tailed deer (Odocoileus virginianus): 1 to (b) Sponsors. See sponsors in 2 mg/lb. § 510.600(c) of this chapter for uses as in (C) Fallow deer (Dama dama): 2 to 4 paragraph (d) of this section. mg/lb.

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(ii) Indications for use. (A) To produce for 30 days before or during hunting sedation, as an analgesic, and as a season. Federal law restricts this drug preanesthetic to local anesthesia. to use by or on the order of a licensed (B) To produce sedation, accom- veterinarian. panied by a shorter period of analgesia. May be used to calm and facilitate han- [79 FR 74020, Dec. 15, 2014, as amended at 80 dling of fractious animals for diag- FR 13230, Mar. 13, 2015] nostic procedures, for minor surgical § 522.2680 Zeranol. procedures, for therapeutic medication for sedation and relief of pain following (a) Specifications. Each pellet con- injury or surgery, and as a tains 12, 18, or 20 milligrams (mg) preanesthetic to local anesthetic. At zeranol. the recommended dosages, can be used (b) Sponsor. See 000061 in § 510.600(c) of in conjunction with local anesthetics, this chapter. such as procaine or lidocaine. (c) Related tolerances. See § 556.760 of (iii) Limitations. Do not use in domes- this chapter. tic food-producing animals. Do not use (d) Conditions of use—(1) Beef cattle— in Cervidae less than 15 days before or (i) Amount. 36 mg zeranol (one implant during the hunting season. consisting of 3 pellets, each pellet con- [68 FR 26206, May 15, 2003, as amended at 75 taining 12 mg zeranol) per implant FR 10167, Mar. 5, 2010, 78 FR 21060, Apr. 9, dose. 2013; 79 FR 16198, Mar. 25, 2014; 79 FR 21127, (ii) Indications for use. (A) For in- Apr. 15, 2014; 79 FR 74020, Dec. 15, 2014; 80 FR creased rate of weight gain and im- 13230, Mar. 13, 2015; 83 FR 48946, Sept. 28, 2018; 84 FR 8974, Mar. 13, 2019] proved feed conversion in weaned beef calves, growing beef cattle, feedlot § 522.2670 Yohimbine. steers, and feedlot heifers. (a) Specifications. Each milliliter (B) For increased rate of weight gain (mL) of solution contains 2 or 5 milli- in suckling calves. grams (mg) of yohimbine (as hydro- (iii) Limitations. Implant chloride). subcutaneously in ear only. Do not use (b) Sponsors. See sponsors in in bulls intended for reproduction or in § 510.600(c) of this chapter for use as in dairy animals. Do not use before 1 paragraph (c) of this section. month of age or after weaning in heif- (1) No. 059399 for use of in 2 mg/mL ers intended for reproduction. Safety solution as in paragraph (c)(1) of this and effectiveness have not been estab- section. lished in veal calves. A withdrawal pe- (2) No. 053923 for use of in 5 mg/mL riod has not been established for this solution as in paragraph (c)(2) of this product in preruminating calves. Do section. not use in calves to be processed for (c) Conditions of use—(1) Dogs—(i) veal. Amount. Administer 0.05 mg per pound (2) Feedlot lambs—(i) Amount. 12 mg (0.11 mg per kilogram) of body weight zeranol (one implant consisting of 1 by intravenous injection. pellet containing 12 mg zeranol) per (ii) Indications for use. To reverse the implant dose. effects of xylazine in dogs. (ii) Indications for use. For increased (iii) Limitations. Not for use in food- producing animals. Federal law re- rate of weight gain and improved feed stricts this drug to use by or on the conversion. order of a licensed veterinarian. (iii) Limitations. Implant (2) Deer and elk—(i) Amount. Admin- subcutaneously in ear only. Do not use ister 0.2 to 0.3 mg per kilogram of body in breeding animals. Do not implant weight by intravenous injection. animals within 40 days of slaughter. (ii) Indications for use. A s an antago- Safety and effectiveness have not been nist to xylazine sedation in free rang- established in veal calves. A with- ing or confined members of the family drawal period has not been established Cervidae (deer and elk). for this product in preruminating (iii) Limitations. Do not use in domes- calves. Do not use in calves to be proc- tic food-producing animals. Do not use essed for veal.

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(3) Steers fed in confinement for slaugh- PART 524—OPHTHALMIC AND TOP- ter—(i) Amount. 72 mg zeranol (one im- ICAL DOSAGE FORM NEW ANI- plant consisting of 6 pellets, each pel- MAL DRUGS let containing 12 mg zeranol) per implant dose. Sec. (ii) Indications for use. For increased 524.86 Amitraz. rate of weight gain and improved feed 524.154 Bacitracin, neomycin, and poly- efficiency. myxin B ophthalmic ointment. (iii) Limitations. Implant 524.155 Bacitracin, neomycin, polymyxin B, subcutaneously in ear only. Safety and and hydrocortisone ophthalmic ointment. effectiveness have not been established 524.390 Chloramphenicol ophthalmic oint- in veal calves. A withdrawal period has ment. not been established for this product in 524.402 Chlorhexidine. preruminating calves. Do not use in 524.450 Clotrimazole. calves to be processed for veal. 524.463 Copper naphthenate. (4) Pasture cattle (slaughter, stocker, 524.575 Cyclosporine ophthalmic ointment. feeder steers, and heifers)—(i) Amount. 524.590 Diclofenac. 524.660 Dimethyl sulfoxide. 138 mg zeranol (one implant consisting 524.770 Doramectin. 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. (ii) Indications for use. For increased 524.815 Eprinomectin and praziquantel. rate of weight gain. 524.900 Famphur. 524.920 Fenthion. (iii) Limitations. Implant 524.955 Florfenicol, terbinafine, and subcutaneously in ear only. Safety and betamethasone acetate otic gel. effectiveness have not been established 524.957 Florfenicol, terbinafine, and in veal calves. A withdrawal period has mometasone otic solution. not been established for this product in 524.960 Flumethasone, neomycin, and poly- preruminating calves. Do not use in myxin B ophthalmic solution. 524.970 Flunixin. calves to be processed for veal. FLUOCINOLONE TOPICAL AND OTIC DOSAGE [59 FR 19639, Apr. 25, 1994; 60 FR 26360, May FORMS 17, 1995, as amended at 62 FR 61625, Nov. 19, 1997; 64 FR 46840, Aug. 27, 1999; 67 FR 6867, 524.981 [Reserved] Feb. 14, 2002; 70 FR 6764, Feb. 9, 2005] 524.981a Fluocinolone cream. 524.981b Fluocinolone solution. § 522.2690 Zinc gluconate. 524.981c Fluocinolone and neomycin cream. 524.981d Fluocinolone and dimethyl sulf- (a) Specifications. Each milliliter of oxide solution. solution contains 13.1 milligrams zinc 524.981e Fluocinolone and dimethyl sulf- as zinc gluconate neutralized to pH 7.0 oxide otic solution. with L-arginine. 524.998 Fluralaner. (b) Sponsor. See No. 076175 in 524.1001 Furalaner and moxidectin. § 510.600(c) of this chapter. 524.1005 Furazolidone powder. 524.1044 Gentamicin sophthalmic and top- (c) Conditions of use in dogs—(1) ical dosage forms. Amount. The volume injected into each 524.1044a Gentamicin ophthalmic solution. testicle is based on testicular width as 524.1044b Gentamicin and betamethasone determined by measuring each testicle otic solution. at its widest point using a metric scale 524.1044c Gentamicin ophthalmic ointment. (millimeter) caliper. 524.1044d Gentamicin and betamethasone ointment. (2) Indications for use. Intratesticular 524.1044e Gentamicin spray. injection for chemical sterilization of 524.1044f Gentamicinand betamethasone 3- to 10-month-old male dogs. spray. (3) Limitations. Federal law restricts 524.1044g Gentamicin, betamethasone, and this drug to use by or on the order of a clotrimazole ointment. licensed veterinarian. 524.1044h Gentamicin, mometasone, and clotrimazole otic suspension. [68 FR 26995, May 19, 2003, as amended at 76 524.1044i Gentamicin and betamethasone FR 79064, Dec. 21, 2011] ophthalmic solution.

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524.1132 Hydrocortisone, miconazole, and 524.2099 Selamectin and sarolaner. gentamicin otic suspension. 524.2101 Selenium disulfide suspension. 524.1140 Imidacloprid and ivermectin. 524.2350 Tolnaftate cream. 524.1146 Imidacloprid and moxidectin. 524.2482 Triamcinolone spray. 524.1193 Ivermectin topical solution. 524.2483 Triamcinolone cream. 524.1195 Ivermectin otic suspension. 524.2620 Liquid crystalline trypsin, Peru 524.1200 Kanamycin ophthalmic and topical balsam, castor oil. dosage forms. 524.1200a Kanamycin ophthalmic ointment. AUTHORITY: 21 U.S.C. 360b. 524.1200b Kanamycin ophthalmic solution. SOURCE: 40 FR 13873, Mar. 27, 1975, unless 524.1204 Kanamycin, amphomycin, and hy- otherwise noted. drocortisone ointment. 524.1240 Levamisole. 524.1376 2-Mercaptobenzothiazole solution. § 524.86 Amitraz. 524.1443 Miconazole. (a) Specifications. Amitraz liquid con- 524.1445 Miconazole, polymixin B, and pred- tains 19.9 percent amitraz in an organic nisolone suspension. solvent. 524.1446 Milbemycin otic solution. 524.1448 Mirtazapine transdermal ointment. (b) Sponsor. See No. 054771 in 524.1450 Moxidectin. § 510.600(c) of this chapter. 524.1465 Mupirocin. (c) Conditions of use—(1) Indications 524.1484 Neomycin ophthalmic and topical for use. For dogs for the treatment of dosage forms. generalized demodicosis (Demodex 524.1484b Neomycin, isoflupredone, tetra- canis). caine, and myristyl-gamma-picolinium (2) Amount. One 10.6 milliliter bottle powder. 524.1484c Neomycin, isoflupredone, and tet- per 2 gallons of warm water (250 parts racaine ointment. per million) for each treatment, for a 524.1484d Neomycin, hydrocortisone, and total of 3 to 6 treatments, 14 days tetracaine otic ointment. apart. 524.1484e Neomycin and polymyxin B oph- (3) Limitations. Federal law restricts thalmic solution. this drug to use by or on the order of a 524.1484f Neomycin, prednisolone, and tetra- licensed veterinarian. caine otic suspension. 524.1484g Neomycin, thiabendazole, and [47 FR 18589, Apr. 30, 1982, as amended at 79 dexamethasone solution. FR 10967, Feb. 27, 2014] 524.1484h Neomycin, penicillin, polymyxin B, and hydrocortisone suspension. § 524.154 Bacitracin, neomycin, and 524.1484i Neomycin and hydrocortisone oint- polymyxin B ophthalmic ointment. ment. 524.1484j Neomycin and prednisolone oph- (a) Specifications. Each gram of oint- thalmic ointment. ment contains: 524.1484k Neomycin and prednisolone sus- (1) 500 units bacitracin, 3.5 milli- pension. grams (mg) neomycin sulfate (equiva- 524.1580 Nitrofurazone topical dosage forms. lent to 3.5 mg neomycin base), and 524.1580a Nitrofurazone ointment. 10,000 units polymyxin B sulfate; or 524.1580b Nitrofurazone soluble powder. 524.1580c Nitrofurazone and butacaine oint- (2) 400 units bacitracin zinc, 5 mg ne- ment. omycin sulfate (equivalent to 3.5 mg 524.1600 Nystatin ophthalmic and topical neomycin base), and 10,000 units poly- dosage forms. myxin 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 524.1610 Orbifloxacin, mometasone furoate scribed in paragraph (a)(1) as in para- monohydrate, and posaconazole suspen- graph (c) of this section. sion. (2) Nos. 000061, 043264, and 059399 for 524.1662 Oxytetracycline ophthalmic and use of product described in paragraph topical dosage forms. (a)(2) as in paragraph (c) of this sec- 524.1662a Oxytetracycline and hydro- tion. cortisone spray. (c) Conditions of use in dogs and cats— 524.1662b Oxytetracycline and polymyxin B ophthalmic ointment. (1) Amount. Apply a thin film over the 524.1742 Phosmet emulsifiable liquid. cornea 3 or 4 times daily. 524.1982 Proparacaine ophthalmic solution. (2) Indications for use. Treatment of 524.2098 Selamectin. superficial bacterial infections of the

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eyelid and conjunctiva of dogs and cats § 524.402 Chlorhexidine. when due to susceptible organisms. (a) Specifications. Each gram of oint- (3) Limitations. Federal law restricts ment contains 10 milligrams this drug to use by or on the order of a chlorhexidine acetate. licensed veterinarian. (b) Sponsors. See Nos. 054771 and [57 FR 37333, Aug. 18, 1992, as amended at 61 058829 in § 510.600(c) of this chapter. FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, (c) Conditions of use in dogs, cats, and 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, horses—(1) Indications for use. For use Feb. 27, 2014; 80 FR 61297, Oct. 13, 2015] as a topical antiseptic ointment for § 524.155 Bacitracin, neomycin, poly- surface wounds. myxin B, and hydrocortisone oph- (2) Limitations. Do not use in horses thalmic ointment. intended for human consumption. (a) Specifications. Each gram of oint- [72 FR 265, Jan. 4, 2007, as amended at 79 FR ment contains 400 units of bacitracin 10967, Feb. 27, 2014] zinc, 5 milligrams (mg) of neomycin sulfate (equivalent to 3.5 mg of neomy- § 524.450 Clotrimazole. cin sulfate), 10,000 units of polymyxin B (a) Specifications. Each gram of cream sulfate, and10 mg of hydrocortisone. contains 10 milligrams of clotrimazole. (b) Sponsors. See Nos. 000061 and (b) Sponsors. See No. 000859 in 043264 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—(1) Amount. (1) Amount. Apply a thin film over the Apply 1⁄4-inch ribbon of cream per cornea three or four times daily. square inch of lesion once daily for 2 to (2) Indications for use. For treating 4 weeks. acute or chronic conjunctivitis caused (2) Indications of use. For the treat- by susceptible organisms. ment of fungal infections of dogs and (3) Limitations. Federal law restricts cats caused by Microsporum canis and this drug to use by or on the order of a Trichophyton mentagrophytes. licensed veterinarian. (3) Limitations. Federal law restricts [57 FR 37333, Aug. 18, 1992, as amended at 61 this drug to use by or on the order of a FR 8873, Mar. 6, 1996; 62 FR 61626, Nov. 19, licensed veterinarian. 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, [40 FR 48128, July 18, 1980, as amended at 79 Feb. 27, 2014] FR 10967, Feb. 27, 2014] § 524.390 Chloramphenicol ophthalmic § 524.463 Copper naphthenate. ointment. (a) Amount. The drug is a 37.5 percent (a) Specifications. Each gram contains solution of copper naphthenate. 10 milligrams chloramphenicol. (b) Sponsors. See Nos. 017135, 054771, (b) Sponsors. See Nos. 043264 and and 058829 in § 510.600(c) of this chapter. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) (c) Conditions of use in dogs and cats— (1) Amount. Apply every 3 hours around Amount. Apply daily to affected hooves the clock for 48 hours, after which until fully healed. night instillations may be omitted. (2) Indications for use. As an aid in (2) Indications for use. For treatment treating horses and ponies for thrush of bacterial conjunctivitis caused by caused by organisms susceptible to pathogens susceptible to chloramphen- copper naphthenate. icol. (3) Limitations. Use on horses and (3) Limitations. Federal law restricts ponies only. Avoid contact around this drug to use by or on the order of a eyes. Do not contaminate feed. Do not licensed veterinarian. Federal law pro- use in horses intended for human con- hibits the use of this drug in food-pro- sumption. ducing animals. [47 FR 4250, Jan. 29, 1982, as amended at 68 [77 FR 4897, Feb. 1, 2012, as amended at 77 FR FR 55825, Sept. 29, 2003; 71 FR 38074, July 5, 64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014] 2006; 79 FR 10967, Feb. 27, 2014]

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§ 524.575 Cyclosporine ophthalmic (b) Sponsor. See No. 054771 in ointment. § 510.600(c) of this chapter. (a) Specifications. Each gram of oint- (c) Conditions of use in horses and —(1) —(i) Apply ment contains 2 milligrams of dogs Amount Horses. topically two to three times daily in an cyclosporine. amount not to exceed 100 mL per day. (b) Sponsor. See No. 000061 in Total duration of therapy should not § 510.600(c) of this chapter. exceed 30 days. (c) Conditions of use—(1) Amount. (ii) Dogs. Apply topically three to 1 Apply a ⁄4-inch strip of ointment di- four times daily in an amount not to rectly on the cornea or into the con- exceed 20 mL per day. Total duration of junctival sac of the affected eye(s) therapy should not exceed 14 days. every 12 hours. (2) Indications for use. To reduce acute (2) Indications for use. For manage- swelling due to trauma. ment of chronic keratoconjunctivitis (3) Limitations. Do not use in horses sicca (KCS) and chronic superficial intended for human consumption. Fed- keratitis (CSK) in dogs. eral law restricts this drug to use by or (3) Limitations. Federal law restricts on the order of a licensed veterinarian. this drug to use by or on the order of a licensed veterinarian. [79 FR 10967, Feb. 27, 2014] [60 FR 48651, Sept. 20, 1995, as amended at 62 § 524.770 Doramectin. FR 48940, Sept. 18, 1997; 79 FR 10967, Feb. 27, (a) Specifications. Each milliliter 2014] (mL) of solution contains 5 milligrams (mg) doramectin. § 524.590 Diclofenac. (b) Sponsor. See No. 054771 in (a) Specifications. Each gram of cream § 510.600(c) of this chapter. contains 10 milligrams diclofenac so- (c) Related tolerances. See § 556.222 of dium. this chapter. (b) Sponsor. See No. 000010 in (d) Special considerations. See § 500.25 § 510.600(c) of this chapter. of this chapter. (c) Conditions of use in horses—(1) (e) Conditions of use in cattle—(1) Amount. Apply a 5-inch (5″) ribbon of Amount. Administer topically as a sin- 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), Trichostrongylus colubriformis (adults (3) Limitations. Do not use in horses and fourth-stage larvae), intended for human consumption. Fed- Cooperia (adults and fourth-stage lar- eral law restricts this drug to use by or oncophora vae), (adults and on the order of a licensed veterinarian. Cooperia punctata fourth-stage larvae), Cooperia pectinata [69 FR 40767, July 7, 2004, as amended at 74 (adults), Cooperia surnabada (adults), FR 26782, June 4, 2009; 74 FR 47436, Sept. 16, Bunostomum phlebotomum (adults), 2009] Oesophagostomum radiatum (adults and fourth-stage larvae), Trichuris spp. § 524.660 Dimethyl sulfoxide. (adults); lungworms: Dictyocaulus (a) Specifications—(1) Each milliliter viviparus (adults and fourth-stage lar- (mL) of solution contains 90 percent di- vae); eyeworms: Thelazia gulosa methyl sulfoxide and 10 percent water. (adults), Thelazia skrjabini (adults); (2) Each milliliter (mL) of gel prod- grubs: Hypoderma bovis and Hypoderma uct contains 90 percent dimethyl sulf- lineatum; sucking lice: Linognathus oxide. vituli, Haematopinus eurysternus, and

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Solenopotes capillatus; biting lice: § 524.802 Enrofloxacin and silver sulfa- Bovicola (Damalinia) bovis; mange diazine otic emulsion. mites: Chorioptes bovis and Sarcoptes (a) Specifications. Each milliliter con- scabiei; horn flies: Haematobia irritans; tains 5 milligrams (mg) enrofloxacin and to control infections and to protect and 10 mg silver sulfadiazine. from reinfection with Cooperia (b) Sponsor. See No. 000859 in oncophora, Dictyocaulus viviparus, § 510.600(c) of this chapter. Ostertagia ostertagi, and (c) Conditions of use—Dogs—(1) Oesophagostomum radiatum for 28 days; Amount. 5 to 10 drops for dogs weighing and with Cooperia punctata and 35 pounds (lb) or less and 10 to 15 drops Haemonchus placei for 35 days after for dogs weighing more than 35 lb; ap- treatment; and to control infestations plied twice daily for up to 14 days. and to protect from reinfestation with (2) Indications for use. For the treat- Linognathus vituli for 42 days and with ment of otitis externa in dogs. Bovicola (Damalinia) bovis for 77 days (3) Limitations. Federal law restricts after treatment. this drug to use by or on the order of a (3) Limitations. Do not slaughter cat- licensed veterinarian. Federal law pro- tle within 45 days of latest treatment. hibits the extralabel use of this drug in This product is not approved for use in food-producing animals. female dairy cattle 20 months of age or [65 FR 66620, Nov. 7, 2000, as amended at 79 older, including dry dairy cows. Use in FR 10967, Feb. 27, 2014] these cattle may cause drug residues in milk and/or in calves born to these § 524.814 Eprinomectin. cows. A withdrawal period has not been (a) Specifications. Each milliliter established for this product in (mL) contains 5 milligrams (mg) of preruminating calves. Do not use in eprinomectin. calves to be processed for veal. (b) Sponsors. See Nos. 000010 and [69 FR 48392, Aug. 10, 2004, as amended at 70 055529 in § 510.600(c) of this chapter. FR 43046, July 26, 2005; 79 FR 10967, Feb. 27, (c) Related tolerances. See § 556.227 of 2014; 84 FR 32993, July 11, 2019] this chapter. (d) Special considerations. See § 500.25 § 524.775 Emodepside and of this chapter. praziquantel. (e) Conditions of use in cattle—(1) (a) Specifications. Each milliliter of Amount. Apply 5 mg (1 mL) per 10 kilo- solution contains 21.4 milligrams (mg) grams (kg) of body weight (500 emodepside and 85.7 mg praziquantel. micrograms/kg) applied topically along (b) Sponsor. See No. 000859 in backbone from withers to tailhead. § 510.600(c) of this chapter. (2) Indications for use. For treatment (c) Conditions of use in cats—(1) and control of gastrointestinal Amount. The recommended minimum roundworms (Haemonchus placei (adult dose is 1.36 mg/pound (lb) (3 mg/kilo- and L4), Ostertagia ostertagi (adult and gram (kg)) emodepside and 5.45 mg/lb L4, including inhibited L4), (12 mg/kg) praziquantel applied as a Trichostrongylus axei (adult and L4), T. single topical dose. colubriformis (adult and L4), T. (2) Indications for use. For the treat- longispicularis (adult), Cooperia ment and control of hookworm infec- 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 parasitic stages Hypoderma lineatum, H. (3) Limitations. Federal law restricts bovis); lice (Damalinia bovis, this drug to use by or on the order of a Linognathus vituli, Haematopinus licensed veterinarian. eurysternus, Solenopotes capillatus); [72 FR 42291, Aug. 2, 2007] mange mites (Chorioptes bovis, Sarcoptes

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scabiei); and horn flies (Haematobia (d) Related tolerances. See § 556.273 of irritans). Controls and protects from re- this chapter. infection of D. viviparus for 21 days (e) Conditions of use—(1) Amount. after treatment and H. irritans for 7 Apply 1 ounce per 200 pounds body days after treatment. weight, not to exceed a total dosage of (3) Limitations. A withdrawal period 4 ounces, from the shoulder to the tail has not been established for head as a single treatment. Apply as preruminating calves. Do not use in soon as possible after heel fly activity calves to be processed for veal. ceases. (2) Indications for use in beef and non- [76 FR 72619, Nov. 25, 2011, as amended at 83 FR 48946, Sept. 28, 2018; 84 FR 39184, Aug. 9, lactating dairy cattle. For control of cat- 2019] tle grubs and to reduce cattle lice infestations. § 524.815 Eprinomectin and (3) Limitations. Do not slaughter with- praziquantel. in 35 days after treatment. Do not use (a) Specifications. Each milliliter on lactating dairy cows or dry dairy (mL) of solution contains 4 milligrams cows within 21 days of freshening, (mg) eprinomectin and 83 mg calves less than 3 months old, animals praziquantel. stressed from castration, overexcite- (b) Sponsor. See No. 000010 in ment or dehorning, sick or convales- § 510.600(c) of this chapter. cent animals. Animals may become de- (c) Conditions of use in cats—(1) hydrated and under stress following Amount. Using the 0.3 mL and 0.9 mL shipment. Do not treat until they are unit applicators, administer a min- in good condition. Brahman and Brah- imum dose of 0.23 mg eprinomectin per man crossbreeds are less tolerant of pound body weight and 4.55 mg cholinesterase-inhibiting insecticides praziquantel per pound body weight by than other breeds. Do not treat Brah- topical application on the dorsal man bulls. Swine should be eliminated midline between the base of the skull from area where runoff occurs. and the shoulder blades. [40 FR 13873, Mar. 27, 1975, as amended at 49 (2) Indications for use. For the preven- FR 34352, Aug. 30, 1984; 57 FR 7652, Mar. 4, tion of heartworm disease caused by 1992; 59 FR 28769, June 3, 1994; 62 FR 55161, Dirofilaria immitis, and for the treat- Oct. 23, 1997; 62 FR 61626, Nov. 19, 1997; 69 FR ment and control of roundworms (adult 41427, July 9, 2004; 79 FR 10968, Feb. 27, 2014; 83 FR 48946, Sept. 28, 2018] and fourth stage larval Toxocara cati), hookworms (adult and fourth stage lar- § 524.920 Fenthion. val Ancylostoma tubaeforme; adult Ancylostoma braziliense), and tapeworms (a) Specifications. (1) The drug is a liq- (adult Dipylidium caninum and uid containing: Echinococcus multilocularis), in cats and (i) 3 percent of fenthion; or kittens 7 weeks of age and older and 1.8 (ii) 20 percent fenthion. lbs or greater. (2) The drug is a solution containing either 5.6 or 13.8 percent fenthion. Each (3) Limitations. Federal law restricts this drug to use by or on the order of a concentration is available in 2 volumes licensed veterinarian. which are contained in single-dose applicators. [83 FR 48946, Sept. 28, 2018, as amended at 84 (b) Sponsor. See sponsors in FR 39184, Aug. 9, 2019] § 510.600(c) of this chapter: (1) No. 000859 for use of product de- § 524.900 Famphur. scribed in paragraph (a)(1)(i) as in para- (a) Specifications. The drug is in liquid graph (d)(1) of this section. form containing 13.2 percent famphur. (2) No. 000859 for use of product de- (b) Sponsor. See No. 000061 in scribed in paragraph (a)(1)(ii) as in § 510.600(c) of this chapter. paragraph (d)(2) of this section. (c) Special considerations. Do not use (3) No. 000859 for use of products de- on animals simultaneously or within a scribed in paragraph (a)(2) as in para- few days before or after treatment with graph (d)(3) of this section. or exposure to cholinesterase-inhib- (c) Related tolerances. See § 556.280 of iting drugs, pesticides, or chemicals. this chapter.

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(d) Conditions of use—(1) Beef cattle sooner than 35 days after the first and nonlactating dairy cattle—(i) treatment. Amount. It is used at the rate of one- (ii) Indications for use. For control of half fluid ounce per 100 pounds of body cattle grubs and as an aid in control- weight applied topically on the ling lice on beef cattle and on dairy backline of the animal. Only one appli- cattle not of breeding age. cation per season should be made for (iii) Limitations. Do not use on ani- grub control and this will also provide mals simultaneously or within a few initial control of lice. A second appli- days before or after treatment with or cation for lice control may be made if exposure to cholinesterase-inhibiting animals become reinfested, but no drugs, pesticides, or chemicals. Host- sooner than 35 days after the first parasite reactions such as bloat, saliva- treatment. Proper timing of treatment tion, staggering and paralysis may is important for grub control; cattle sometimes occur when cattle are treat- should be treated as soon as possible ed while the common cattle grub after heel-fly activity ceases. (Hypoderma lineatum) is in the gullet, (ii) Indications for use. For the control or while the northern cattle grub (H. of grubs and lice in beef and nonlac- bovis) is in the area of the spinal cord. tating cattle. Cattle should be treated before these (iii) Limitations. Do not use on ani- stages of grub development. Consult mals simultaneously or within a few your veterinarian, extension livestock days before or after treatment with or specialist, or extension entomologist exposure to cholinesterase-inhibiting regarding the timing of treatment. If it drugs, pesticides, or chemicals. Cattle is impossible to determine the area should not be slaughtered within 35 from which the cattle came and/or days following a single treatment. If a exact stage of the grubs, it is rec- second application is made for lice con- ommended that the cattle receive only trol, cattle should not be slaughtered a maintenance ration of low-energy within 45 days of the second treatment. feed during the treatment period. This The drug must not be used within 28 lessens the likelihood of severe bloat days of freshening of dairy cattle. If which may occur in cattle on full feed freshening should occur within 28 days when the common grub is killed while after treatment, do not use milk as in the gullet. Do not treat dairy cattle human food for the balance of the 28- of breeding age; calves less than 3 day interval. Do not treat lactating months old; sick, convalescent, or se- dairy cattle; calves less than 3 months verely stressed livestock. Do not treat old; or sick, convalescent, or stressed cattle for 10 days before or after ship- livestock. Do not treat cattle for 10 ping, weaning, dehorning, or after ex- days before or after shipping, weaning, posure to contagious or infectious dis- or dehorning or after exposure to con- eases. Do not slaughter within 45 days tagious infectious diseases. of treatment. (2) Beef cattle and dairy cattle not of (3) Dogs—(i) Amount. Four to 8 milli- breeding age—(i) Amount. It is adminis- grams per kilogram of body weight. tered as a single, topical application Apply the contents of the proper size, placed on the backline of animals as single-dose tube directly to one spot on follows: For animals weighing 150 to the dog’s skin. 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, as amended at 84 tive results, cattle should be treated as FR 32993, July 11, 2019] soon as possible after heel-fly activity ceases. A second application is required § 524.955 Florfenicol, terbinafine, and for animals heavily infested with lice betamethasone acetate otic gel. or for those which become reinfested. A (a) Specifications. Each milliliter of second application should be made no gel contains 10 milligrams (mg)

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florfenicol, 10 mg terbinafine, and 1 mg (ii) Preparation without hydroxyproply betamethasone acetate. methylcellulose. Dogs and cats: 2 to 3 (b) Sponsor. See No. 058198 in drops per eye, every 4 hours. § 510.600(c) of this chapter. (2) Indications for use. Treatment of (c) Conditions of use in dogs—(1) the inflammation, edema, and sec- Amount. Administer one dose (1 tube) ondary bacterial infections associated per affected ear(s) and repeat adminis- with topical ophthalmological condi- tration in 7 days. tions of the eye such as corneal inju- (2) Indications for use. For the treat- ries, incipient pannus, superficial kera- ment of otitis externa in dogs associ- titis, conjunctivitis, acute ated with susceptible strains of bac- nongranulomatous anterior uveitis, teria (Staphylococcus pseudintermedius) keratoconjunctivitis, and blepharitis. and yeast (Malassezia pachydermatis). (3) Limitations. Federal law restricts (3) Limitations. Federal law restricts this drug to use by or on the order of a this drug to use by or on the order of a licensed veterinarian. licensed veterinarian. [80 FR 13230, Mar. 13, 2015] [44 FR 16012, Mar. 16, 1979, as amended at 61 FR 5507, Feb. 13, 1996; 79 FR 10968, Feb. 27, § 524.957 Florfenicol, terbinafine, and 2013] mometasone otic solution. § 524.970 Flunixin. (a) Specifications. Each single-dose, prefilled dropperette contains 1 milli- (a) Specifications. Each milliliter of liter (mL) of a solution containing 16.6 solution contains 50 milligrams (mg) milligrams (mg) florfenicol, 14.8 mg flunixin (equivalent to 83 mg flunixin terbinafine (equivalent to 16.6 mg meglumine). terbinafine hydrochloride), and 2.2 mg (b) Sponsor. See No. 000061 in mometasone furoate. § 510.600(c) of this chapter. (b) Sponsor. See No. 000859 in (c) Related tolerances. See § 556.286 of § 510.600(c) of this chapter. this chapter. (c) Conditions of use in dogs—(1) (d) Conditions of use—(1) Amount. Amount. Administer one dropperette (1 Apply only once at a dose of 3.3 mg mL) per affected ear(s). flunixin per kg body weight (1.5 mg/lb; (2) Indications for use. For the treat- 3 mL per 100 lbs) topically in a narrow ment of otitis externa in dogs associ- strip along the dorsal midline from the ated with susceptible strains of yeast withers to the tailhead. (Malassezia pachydermatis) and bacteria (2) Indications for use. For the control (Staphylococcus pseudintermedius). of pyrexia associated with bovine res- (3) Limitations. Federal law restricts piratory disease and the control of pain this drug to use by or on the order of a associated with foot rot in steers, beef licensed veterinarian. heifers, beef cows, beef bulls intended [80 FR 76387, Dec. 9, 2015, as amended at 83 for slaughter, and replacement dairy FR 64740, Dec. 18, 2018] heifers under 20 months of age. (3) Limitations. Federal law restricts § 524.960 Flumethasone, neomycin, and polymyxin B ophthalmic solu- this drug to use by or on the order of a tion. licensed veterinarian. Cattle must not be slaughtered for human consumption (a) Specifications. Each milliliter of within 8 days of the last treatment. ophthalmic preparation contains 0.10 Not for use in female dairy cattle 20 milligram flumethasone, 5.0 milligrams months of age or older, including dry neomycin sulfate (3.5 milligrams neo- dairy cows; use in these cattle may mycin base), and 10,000 units of poly- cause drug residues in milk and/or in myxin B sulfate, with or without calves born to these cows or heifers. hydroxypropyl methylcellulose. Not for use in suckling beef calves, (b) See No. 054771 in Sponsor. dairy calves, and veal calves. A with- § 510.600(c) of this chapter. drawal period has not been established (c) Conditions of use—(1) Amount—(i) for this product in pre-ruminating Preparation containing hydroxypropyl calves. methylcellulose. Dogs: 1 to 2 drops per eye, every 6 hours. [83 FR 13635, Mar. 30, 2018]

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FLUOCINOLONE TOPICAL AND OTIC and 0.5 percent neomycin sulfate (0.35 DOSAGE FORMS percent neomycin base). (b) Sponsor. See No. 099207 in § 524.981 [Reserved] § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) § 524.981a Fluocinolone cream. Amount—A small amount is applied to (a) Specifications. The drug contains the affected area two or three times 0.025 percent fluocinolone acetonide. daily. (b) Sponsor. See No. 099207 in (2) Indications for use—(i) Dogs. For § 510.600(c) of this chapter. the relief of pruritis and inflammation (c) Conditions of use in dogs—(1) associated with superficial acute and Amount—A small amount is applied to chronic dermatoses. It is used in the the affected area two or three times treatment of allergic and acute moist daily. dermatitis and nonspecific dermatoses. (2) Indications for use. For the relief of (ii) Dogs and cats. Used in the treat- pruritis and inflammation associated ment of wound infections. with certain superficial acute and (3) Federal law restricts this drug to chronic dermatoses. It is used in the use by or on the order of a licensed vet- treatment of allergic and acute moist erinarian. dermatitis and for the relief of super- [40 FR 13873, Mar. 27, 1975, as amended at 62 ficial inflammation caused by chemical FR 40932, July 31, 1997; 79 FR 10969, Feb. 27, burns and physical abrasions. 2014] (3) Federal law restricts this drug to use by or on the order of a licensed vet- § 524.981d Fluocinolone and dimethyl sulfoxide solution. erinarian. (a) Specifications. Each milliliter of [40 FR 13873, Mar. 27, 1975, as amended at 62 solution contains 0.01 percent FR 40932, July 31, 1997; 79 FR 10968, Feb. 27, fluocinolone acetonide and 20 percent 2014] dimethyl sulfoxide. § 524.981b Fluocinolone solution. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (a) Specifications. The drug contains (c) Conditions of use in dogs—(1) 0.01 percent fluocinolone acetonide. Amount—Instill 1 to 2 milliliters into (b) Sponsor. See No. 099207 in each anal sac following expression of § 510.600(c) of this chapter. anal sac contents. (c) Conditions of use in dogs—(1) (2) Indications for use. For the relief of Amount—A small amount of solution is impaction commonly present in appar- applied to the affected area two or ently normal anal sacs, for the reversal three times daily. of inflammatory changes associated (2) Indications for use—(i) Dogs. For with abnormal anal sacs, and to coun- the relief of pruritis and inflammation teract the offensive odor of anal sac se- associated with otitis externa and cer- cretions. tain superficial acute and chronic (3) Limitations. Federal law restricts dermatoses. this drug to use by or on the order of a (ii) Cats. For the relief of pruritis and licensed veterinarian. inflammation associated with acute [79 FR 10969, Feb. 27, 2014] otitis externa and certain superficial acute and chronic dermatoses. § 524.981e Fluocinolone and dimethyl (3) Federal law restricts this drug to sulfoxide otic solution. use by or on the order of a licensed vet- (a) Specifications. Each milliliter of erinarian. solution contains 0.01 percent [40 FR 13873, Mar. 27, 1975, as amended at 62 fluocinolone acetonide and 60 percent FR 40932, July 31, 1997; 79 FR 10969, Feb. 27, dimethyl sulfoxide. 2014] (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 524.981c Fluocinolone and neomycin (c) Conditions of use in dogs—(1) cream. Amount—Instill 4 to 6 drops (0.2 milli- (a) Specifications. The drug contains liter) twice daily into the ear canal for 0.025 percent fluocinolone acetonide a maximum period of 14 days. The total

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dosage used should not exceed 17 milli- tens 6 months of age and older, and liters. weighing 2.6 lb or greater. (2) Indications for use. For the relief of (iii) Limitations. Federal law restricts pruritis and inflammation associated this drug to use by or on the order of a with acute and chronic otitis. licensed veterinarian. (3) Limitations. Federal law restricts this drug to use by or on the order of a [81 FR 67152, Sept. 30, 2016, as amended at 82 licensed veterinarian. FR 43485, Sept. 18, 2017] [79 FR 10969, Feb. 27, 2014] § 524.1001 Furalaner and moxidectin. § 524.998 Fluralaner. (a) Specifications. Each milliliter of solution contains 280 milligram (mg) (a) Specifications. Each milliliter of solution contains 280 milligrams (mg) furalaner and 14 mg moxidectin. Each fluralaner. individually packaged tube contains ei- (b) Sponsor. See No. 000061 in ther 112.5 mg furalaner and 5.6 mg § 510.600(c) of this chapter. moxidectin; 250 mg furalaner and 12.5 (c) Conditions of use—(1) Dogs—(i) mg moxidectin; or 500 mg furalaner and Amount. Administer topically as a sin- 25 mg moxidectin. gle dose every 12 weeks according to (b) Sponsor. See No. 000061 in the label dosage schedule to provide a § 510.600(c) of this chapter. minimum dose of 11.4 mg/lb (25 mg/kg) (c) Conditions of use—(1) Amount. Ad- body weight. May be administered minister topically as a single dose every 8 weeks in case of potential expo- every 2 months to provide a minimum sure to Amblyomma americanum ticks. dose of 18.2 mg/lb (40 mg/kg) fluralaner (ii) Indications for use. Kills adult and 0.9 mg/lb (2 mg/kg) moxidectin. fleas; for the treatment and prevention (2) Indications for use. For the preven- of flea infestations (Ctenocephalides tion of heartworm disease caused by felis) and the treatment and control of Dirofilaria immitis and for the treatment tick infestations (Ixodes scapularis of infections with intestinal (black-legged tick), Dermacentor roundworm (Toxocara cati, 4th stage variabilis (American dog tick), and larvae, immature adults, and adults) Rhipicephalus sanguineus (brown dog and hookworm (Ancylostoma tubaeforme, tick)) for 12 weeks in dogs and puppies 4th stage larvae, immature adults, and 6 months of age and older, and weigh- adults); kills adult fleas and is indi- ing 4.4 lb or greater; for the treatment cated for the treatment and prevention and control of A. americanum (lone star tick) infestations for 8 weeks in dogs of flea infestations (Ctenocephalides and puppies 6 months of age and older, felis) and the treatment and control of and weighing 4.4 lb or greater. tick infestations (Ixodes scapularis (iii) Limitations. Federal law restricts (black-legged tick) and Dermacentor this drug to use by or on the order of a variabilis (American dog tick)) for 2 licensed veterinarian. months in cats and kittens 6 months of (2) Cats—(i) Amount. Administer topi- age and older and weighing 2.6 lb or cally as a single dose every 12 weeks greater. according to the label dosage schedule (3) Limitations. Federal law restricts to provide a minimum dose of 18.2 mg/ this drug to use by or on the order of a lb (40 mg/kg) body weight. May be ad- licensed veterinarian. ministered every 8 weeks in case of po- [85 FR 18120, Apr. 1, 2020] tential exposure to D. variabilis ticks. (ii) Indications for use. Kills adult § 524.1005 Furazolidone powder. fleas; for the treatment and prevention of flea infestations (C. felis) and the (a) Specifications. The product con- treatment and control of I. scapularis tains either 4 or 10 percent furazolidone (black-legged tick) infestations for 12 in inert dispersing agent and propel- weeks in cats and kittens 6 months of lant. age and older, and weighing 2.6 lb or (b) Sponsors. (1) See No. 051031 in greater; for the treatment and control § 510.600(c) of this chapter for use as in of D. variabilis (American dog tick) in- paragraphs (c)(1), (c)(2)(i), (c)(2)(ii), and festations for 8 weeks in cats and kit- (c)(3) of this section.

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(2) See No. 017135 for use of the 4 per- (c) Conditions of use in dogs and cats— cent product as in paragraph (c)(2)(iv) (1) Amount. Administer 1 or 2 drops into of this section. the conjunctival sac 2 to 4 times a day. (c) Conditions of use—(1) Amount. Hold (2) Indications for use. For the topical container about 6 to 12 inches from the treatment of infections of the con- eye or affected area and apply only junctiva caused by susceptible bac- enough powder to impart a light yellow teria. color. (3) Limitations. Federal law restricts (2) Indications of use—(i) Dogs. For this drug to use by or on the order of a treatment or prevention of bacterial licensed veterinarian. infection of superficial wounds, abrasions, lacerations, and pyogenic derma- [80 FR 18776, Apr. 8, 2015] titis. (ii) Horses. For treatment or preven- § 524.1044b Gentamicin and betamethasone otic solution. tion of bacterial infection of superficial wounds, abrasions, lacerations, and fol- (a) Specifications. Each milliliter of lowing firing (heat or electrocautery). solution contains gentamicin sulfate (iii) [Reserved] equivalent to 3 milligrams (mg) (iv) Horses and ponies. For treatment gentamicin base and betamethasone or prevention of bacterial infection of valerate equivalent to 1 mg superficial wounds, abrasions, and lac- betamethasone alcohol. erations caused by Staphylococcus (b) Sponsors. See Nos. 000061 and aureus, Streptococcus spp. and Proteus 054925 in § 510.600(c) of this chapter. spp. sensitive to furazolidone. (c) Conditions of use—(1) Amounts and (3) Limitations. For topical applica- indications for use—(i) For the treat- tion in horses, ponies, and dogs: Clean ment of acute and chronic otitis affected area thoroughly, apply drug externa caused by bacteria sensitive to once or twice daily, and repeat treat- gentamicin in dogs, instill three to ment as required. Use only as rec- eight drops of solution into the ear ommended by a veterinarian in treat- canal twice daily for 7 to 14 days. ment of puncture wounds, wounds re- (ii) For the treatment of infected su- quiring surgical debridement or sutur- perficial lesions caused by bacteria ing, those of a chronic nature involving sensitive to gentamicin in dogs and proud flesh, generalized and chronic in- cats, apply a sufficient amount of the fections of the skin, and those skin drug to cover the treatment area twice conditions associated with intense daily for 7 to 14 days. itching. If redness, irritation, or swell- (2) Limitations. Federal law restricts ing persists or increases, discontinue this drug to use by or on the order of a use and consult a veterinarian. Do not licensed veterinarian. use in horses intended for human consumption. [71 FR 13542, Mar. 16, 2006]

[45 FR 49543, July 25, 1980, as amended at 50 § 524.1044c Gentamicin ophthalmic FR 30153, July 24, 1985; 56 FR 50653, Oct. 8, 1991; 57 FR 31314, July 15, 1992; 60 FR 55659, ointment. Nov. 2, 1995; 65 FR 41588, July 6, 2000; 79 FR (a) Specifications. Each gram of oint- 10969, Feb. 27, 2014; 82 FR 11508, Feb. 24, 2017] ment contains gentamicin sulfate equivalent to 3 milligrams of § 524.1044 Gentamicin ophthalmic and gentamicin. topical dosage forms. (b) Sponsors. See Nos. 000061 and § 524.1044a Gentamicin ophthalmic so- 026637 in § 510.600(c) of this chapter. lution. (c) Conditions of use in dogs and cats— (a) Specifications. Each milliliter of (1) Amount. Apply approximately a 1/2- solution contains gentamicin sulfate inch strip to the affected eye 2 to 4 equivalent to 3 milligrams of times a day. gentamicin. (2) Indications for use. For treatment (b) Sponsors. See Nos. 000061 and of conjunctivitis caused by susceptible 059399 in § 510.600(c) of this chapter. bacteria.

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(3) Limitations. Federal law restricts similar signs. If conditions persists or this drug to use by or on the order of a increases, discontinue use and consult licensed veterinarian. a veterinarian. [69 FR 47363, Aug. 5, 2004, as amended at 77 [48 FR 41157, Sept. 14, 1983, as amended 52 FR FR 64717, Oct. 23, 2012; 85 FR 4208, Jan. 24, 7833, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2014; 2020] 84 FR 32993, July 11, 2019]

§ 524.1044d Gentamicin and § 524.1044f Gentamicin and betamethasone ointment. betamethasone spray. (a) Specifications. Each gram of oint- (a) Specifications. Each milliliter of ment contains gentamicin sulfate spray contains gentamicin sulfate equivalent to 3 milligrams of equivalent to 0.57 milligram (mg) gentamicin base and betamethasone gentamicin base and betamethasone valerate equivalent to 1 milligram of valerate equivalent to 0.284 mg betamethasone. betamethasone. (b) Sponsor. See No. 000061 in (b) Sponsors. See Nos. 000061, 054925, § 510.600(c) of this chapter. 058005, and 058829 in § 510.600(c) of this (c) Conditions of use in dogs—(1) chapter. Amount—(i) Otitis externa. Instill 3 to 8 (c) Conditions of use in dogs—(1) drops into the ear canal twice daily for Amount. Hold bottle upright 3 to 6 7 days. inches from the lesion and depress the (ii) Infected superficial lesions. Apply sprayer head twice. Administer two to cover the treatment area twice daily spray actuations two to four times for 7 to 14 days. daily for 7 days. (2) Indications for use. For the treat- (2) Indications for use. For the treatment of acute and chronic otitis ment of infected superficial lesions externa and infected superficial lesions caused by bacteria susceptible to caused by bacteria sensitive to gentamicin. gentamicin. (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. [71 FR 13542, Mar. 16, 2006, as amended at 72 [47 FR 26378, June 18, 1982, as amended at 52 FR 5929, Feb. 8, 2007; 74 FR 22822, May 15, FR 7832, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2009; 77 FR 3598, Jan. 25, 2012; 85 FR 4208, Jan. 2014] 24, 2020]

§ 524.1044e Gentamicin spray. § 524.1044g Gentamicin, (a) Specification. Each milliliter of betamethasone, and clotrimazole sterile aqueous solution contains ointment. gentamicin sulfate equivalent to 1.07 (a) Specifications. Each gram (g) of milligrams of gentamicin. ointment contains gentamicin sulfate (b) Sponsor. See No. 000061 in equivalent to 3 milligrams (mg) § 510.600(c) of this chapter. gentamicin base, betamethasone val- (c) Related tolerances. See § 556.300 of erate equivalent to 1 mg this chapter. betamethasone, and 10 mg (d) Conditions of use in cattle—(1) clotrimazole. Amount. Hold the sprayer upright 3 to 6 (b) Sponsors. See sponsors in inches from the affected eye, with the § 510.600(c) of this chapter for uses as in opening directed towards the eye, and paragraph (c) of this section. pump once. Treat once daily for up to (1) No. 000061 for use of 7.5- or 15-gram 3 days. (g) tubes, 12.5-, 30-, or 215-g bottles. (2) Indications for use. For the treat- (2) No. 054925 for use of 7.5- or 15-g ment of pinkeye in cattle (infectious tubes; 10-, 15-, 25-, or 215-g bottles. bovine keratoconjunctivitis) caused by (3) No. 069043 for use of 10-, 20-, 40-, or Moraxella bovis. 215-g bottles. (3) Limitations. Conditions other than (4) No. 025463 for use of 7.5- or 15-g bacterial infections of the bovine eye tubes, or 215-g bottles. and infectious keratoconjunctivitis (c) Conditions of use in dogs—(1) caused by Moraxella bovis may produce Amount. Instill ointment twice daily

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into the ear canal for 7 consecutive Proteus mirabilis, and beta-hemolytic days. streptococci). (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. (ii) From 20-, 40-, or 215-g bottles: 2 [66 FR 712, Jan. 4, 2001, as amended at 68 FR drops for dogs weighing less than 30 lb 15370, Mar. 31, 2003; 70 FR 36338, June 23, 2005; or 4 drops for dogs weighing 30 lb or 79 FR 10969, Feb. 27, 2014; 81 FR 59134, Aug. 29, 2016] more. (ii) From 20- or 215-g bottles: 2 drops § 524.1044i Gentamicin and for dogs weighing less than 30 lb or 4 betamethasone ophthalmic solution. drops for dogs weighing 30 lb or more. (2) Indications for use. For the treat- (a) Specifications. Each milliliter ment of acute and chronic canine otitis (mL) of solution contains gentamicin externa associated with yeast sulfate equivalent to 3 milligrams (mg) (Malassezia pachydermatis, formerly of gentamicin base and 1 mg Pityrosporum canis) and/or bacteria sus- betamethasone acetate equivalent to ceptible to gentamicin. 0.89 mg betamethasone alcohol. (3) Limitations. Federal law restricts (b) Sponsor. See No. 000061 in this drug to use by or on the order of a § 510.600(c) of this chapter. licensed veterinarian. (c) Conditions of use in dogs—(1) [58 FR 38973, July 21, 1993, as amended at 63 Amount. Instill one or two drops of so- FR 31932, June 11, 1998; 68 FR 42970, July 21, lution in the conjunctival sac three or 2003; 70 FR 8291, Feb. 18, 2005; 71 FR 13542, four times a day. Mar. 16, 2006; 71 FR 16481, Apr. 3, 2006; 71 FR (2) Indications for use. For treatment 38261, July 6, 2006; 71 FR 56867, Sept. 28, 2006; of external eye infections and inflam- 78 FR 17597, Mar. 22, 2013; 79 FR 10969, Feb. 27, 2014; 81 FR 17608, Mar. 30, 2016] mation. (3) Limitations. Federal law restricts § 524.1044h Gentamicin, mometasone, this drug to use by or on the order of a and clotrimazole otic suspension. licensed veterinarian. (a) Specifications. Each gram of sus- [75 FR 54492, Sept. 8, 2010, as amended at 80 pension contains gentamicin sulfate, FR 13230, Mar. 13, 2015] United States Pharmacopeia (USP) equivalent to 3 milligram (mg) § 524.1132 Hydrocortisone, miconazole, gentamicin base, mometasone furoate and gentamicin otic suspension. monohydrate or mometasone furoate (a) Specifications. Each milliliter anhydrous, USP, equivalent to 1 mg (mL) of suspension contains 1.11 milli- mometasone, and 10 mg clotrimazole, grams (mg) hydrocortisone aceponate, USP. 17.4 mg miconazole nitrate, and 1.5 mg (b) Sponsors. See Nos. 000061 and 054925 in § 510.600(c) of this chapter. gentamicin (as gentamicin sulfate). (c) Conditions of use in dogs—(1) (b) Sponsor. See No.051311 in Amount. For dogs weighing less than 30 § 510.600(c) of this chapter. pounds (lb), instill 4 drops from the 7.5- (c) Conditions of use in dogs—(1) , 15-, or 30-gram (g) bottle into the ear Amount. Instill 1.0 mL in the affected canal (2 drops from the 215-g bottle) or, ear once daily for 5 days. for dogs weighing 30 lb or more, instill (2) Indications for use. For the treat- 8 drops from the 7.5-, 15-, or 30-g bottle ment of otitis externa in dogs associ- into the ear canal (4 drops from the 215- ated with susceptible strains of yeast g bottle), once or twice daily for 7 days. (Malassezia pachydermatis) and bacteria (2) Indications for use. For the treat- (Staphylococcus pseudintermedius). ment of otitis externa caused by sus- (3) Limitations. Federal law restricts ceptible strains of yeast (Malassezia this drug to use by or on the order of a pachydermatis) and bacteria licensed veterinarian. (Pseudomonas spp. [including P. aeruginosa], coagulase-positive [76 FR 78150, Dec. 16, 2011, as amended at 83 staphylococci, Enterococcus faecalis, FR 13635, Mar. 30, 2018]

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§ 524.1140 Imidacloprid and stenocephala), and whipworms (Trichuris ivermectin. vulpis); kills adult fleas and treats flea (a) Specifications. The product is infestations (Ctenocephalides felis). available in unit applicator tubes con- (B) For treatment of Dirofilaria taining 0.4, 1.0, 2.5, or 4.0 milliliters immitis circulating microfilariae in (mL). Each mL of solution contains 100 heartworm-positive dogs and the treat- milligrams (mg) imidacloprid and 800 ment and control of sarcoptic mange micrograms (μg) ivermectin. caused by Sarcoptes scabiei var. canis. (b) Sponsor. See No. 000859 in (2) Cats—(i) Amount. Topically apply § 510.600(c) of this chapter. 4.5 mg/lb body weight (10 mg/kg) (c) Conditions of Use in Dogs—(1) imidacloprid and 0.45 mg/lb (1.0 mg/kg) Amount. The recommended minimum moxidectin, once a month. dosage is 4.5 mg/pound (lb) (10 mg/kilo- (ii) Indications for use. For the pre- gram (kg)) of imidacloprid and 36.4 μg/ vention of heartworm disease caused lb (80 μg/kg) of ivermectin, topically by Dirofilaria immitis; for the treatment once a month. and control of ear mite (Otodectes (2) Indications for Use. For the preven- cynotis) infestations, intestinal tion of heartworm disease caused by roundworms (Toxocara cati), and Dirofilaria immitis; kills adult fleas and hookworms (Ancylostoma tubaeforme); is indicated for the treatment of flea kills adult fleas and treats flea infesta- infestations (Ctenocephalides felis). tions (Ctenocephalides felis). (3) Limitations. Federal law restricts (3) Ferrets—(i) Amount. Topically this drug to use by or on the order of a apply 9.0 mg/lb body weight (20 mg/kg) licensed veterinarian. imidacloprid and 0.9 mg/lb (2 mg/kg) [67 FR 78685, Dec. 26, 2002] moxidectin, once a month. (ii) Indications for use. For the pre- § 524.1146 Imidacloprid and vention of heartworm disease caused moxidectin. by Dirofilaria immitis; kills adult fleas (a) Specifications. Each milliliter of (Ctenocephalides felis) and is indicated solution contains: for the treatment of flea infestations (1) 100 milligrams (mg) imidacloprid on ferrets. and 25 mg moxidectin; or (2) 100 mg imidacloprid and 10 mg [72 FR 10597, Mar. 9, 2007, as amended at 78 moxidectin. FR 73698, Dec. 9, 2013; 85 FR 18120, Apr. 1, (b) Sponsors. See sponsor numbers in 2020] § 510.600(c) of this chapter as follows: (1) Nos. 000859 and 017030 for use of § 524.1193 Ivermectin topical solution. product described in paragraph (a)(1) of (a) Specifications. Each milliliter this section as in paragraph (d)(1) of (mL) of solution contains 5 milligrams this section. of ivermectin. (2) No. 000859 for use of product de- (b) Sponsors. See sponsors in scribed in paragraph (a)(2) of this sec- § 510.600(c) of this chapter for use as in tion as in paragraphs (d)(2) and (3) of paragraph (e) of this section. this section. (1) Nos. 000010, 055529, 058829, 061133 (c) Special considerations. Federal law for use as in paragraphs (e)(1), (e)(2)(i), restricts this drug to use by or on the (e)(2)(iii), and (e)(3) of this section. order of a licensed veterinarian. (d) Conditions of use—(1) Dogs—(i) (2) Nos. 016592, 054925, and 058005 for Amount. Topically apply 4.5 mg/lb body use as in paragraphs (e)(1), (e)(2)(i), weight (10 mg/kg) imidacloprid and 1.1 (e)(2)(ii), and (e)(3) of this section. mg/lb (2.5 mg/kg) moxidectin, once a (c) Related tolerances. See § 556.344 of month. this chapter. (ii) Indications for use. (A) For the (d) Special considerations. See § 500.25 prevention of heartworm disease of this chapter. caused by Dirofilaria immitis; and the (e) Conditions of use in cattle—(1) treatment and control of intestinal Amount. One mL per 22 pounds (0.5 mil- roundworms (Toxocara canis and ligram per kilogram) of body weight Toxascaris leonina), hookworms applied topically to the back of the (Ancylostoma caninum and Uncinaria animal.

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(2) Indications for use—(i) It is used (c) Conditions of use—(1) Amount. Ad- for the treatment and control of: Gas- minister the contents of one 0.5-mL trointestinal roundworms (adults and tube topically into each external ear fourth-stage larvae) Ostertagia ostertagi canal. (including inhibited stage), Haemonchus (2) Indications for use. For the treat- placei, Trichostrongylus axei, T. ment of adult ear mite (Otodectes colubriformis, Cooperia oncophora, C. cynotis) infestations in cats and kittens punctata, C. surnabada, 4 weeks of age and older. Effectiveness Oesophagostomum radiatum; (adults) against eggs and immature stages has Strongyloides papillosus, Trichuris spp.; not been proven. lungworms (adults and fourth-stage larvae) Dictyocaulus viviparus; cattle (3) Limitations. Federal law restricts grubs (parasitic stages) Hypoderma this drug to use by or on the order of a bovis, H. lineatum; mites Sarcoptes licensed veterinarian. scabiei var. bovis; lice Linognathus vituli, [66 FR 7578, Jan. 24, 2001, as amended at 74 Haematopinus eurysternus, Damalinia FR 26782, June 4, 2009] bovis, Solenoptes capillatus; and horn flies Haematobia irritans. § 524.1200 Kanamycin ophthalmic and (ii) It controls infections and pre- topical dosage forms. vents reinfection with O. ostertagi, O. radiatum, H. placei, T. axei, C. punctata, § 524.1200a Kanamycin ophthalmic and C. oncophora for 14 days after ointment. treatment. (a) Specifications. Each gram of oint- (iii) It controls infections and pre- ment contains 3.5 milligrams vents reinfection with O. radiatum and kanamycin activity as kanamycin sul- D. viviparus for 28 days after treatment, fate. and for 21 days after C. punctata T. axei (b) Sponsor. See No. 054771 in treatment, O. ostertagi, H. placei, C. § 510.600(c) of this chapter. oncophora, and C. surnabada for 14 days after treatment, and D. bovis for 56 (c) Conditions of use in dogs—(1) days after treatment. Amount. Apply a thin film to the af- (3) Limitations. Do not treat cattle fected eye three or four times daily or within 48 days of slaughter. Because a more frequently if deemed advisable. withdrawal time in milk has not been Treatment should be continued for at established, do not use in female dairy least 48 hours after the eye appears cattle of breeding age. A withdrawal normal. period has not been established for this (2) Indications for use. For the treat- product on preruminating calves. Do ment of various eye infections (con- not use on calves to be processed for junctivitis, blepharitis, dacryocystitis, veal. keratitis, and corneal ulcerations) due [55 FR 50551, Dec. 7, 1990, as amended at 62 to bacteria sensitive to kanamycin. FR 38908, July 21, 1997; 62 FR 63271, Nov. 28, For prophylaxis in traumatic condi- 1997; 63 FR 44385, Aug. 19, 1998; 66 FR 13236, tions, removal of foreign bodies, and Mar. 5, 2001; 66 FR 63165, Dec. 5, 2001; 68 FR intraocular surgery. 3817, Jan. 27, 2003; 68 FR 4713, Jan. 30, 2003; 69 (3) Limitations. Federal law restricts FR 501, Jan. 6, 2004; 69 FR 62181, Oct. 25, 2004; 71 FR 13542, Mar. 16, 2006; 72 FR 6464, Feb. 12, this drug to use by or on the order of a 2007; 74 FR 36112, July 22, 2009; 75 FR 26648, licensed veterinarian. May 12, 2010; 76 FR 81807, Dec. 29, 2011; 78 FR [79 FR 10969, Feb. 27, 2014] 17597, Mar. 22, 2013; 78 FR 63872, Oct. 25, 2013; 81 FR 25328, Apr. 28, 2016; 83 FR 13635, Mar. 30, 2018; 84 FR 8974, Mar. 13, 2019; 84 FR 39184, § 524.1200b Kanamycin ophthalmic so- Aug. 9, 2019] lution. (a) Specifications. Each milliliter of § 524.1195 Ivermectin otic suspension. solution contains 10 milligrams (a) Specifications. Each tube contains kanamycin activity as kanamycin sul- 0.5 milliliter (mL) of a 0.01 percent sus- fate. pension of ivermectin. (b) Sponsor. See No. 054771 in (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. § 510.600(c) of this chapter.

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(c) Conditions of use in dogs—(1) liter of diethylene glycol monobutyl Amount. Instill a few drops into the af- ether (DGME) solution. fected eye every 3 hours or more fre- (b) Sponsors. See Nos. 000061 and quently if deemed advisable. Admin- 054771 in § 510.600(c) of this chapter. ister as frequently as possible for the (c) Related tolerances. See § 556.350 of first 48 hours, after which the fre- this chapter. quency of applications may be de- (d) Conditions of use. Cattle—(1) creased. Treatment should be contin- Amount. 2.5 milliliters per 110 pounds ued for at least 48 hours after the eye (10 milligrams of levamisole per kilo- appears normal. gram) of body weight as a single dose (2) Indications for use. For the treat- topically to the back of the animal. ment of various eye infections (con- (2) Indications for use. Anthelmintic junctivitis, blepharitis, dacryocystitis, effective against stomach worms keratitis, and corneal ulcerations) due (Haemonchus, Trichostrongylus, to bacteria sensitive to kanamycin. Ostertagia), intestinal worms For prophylaxis in traumatic condi- (Trichostrongylus, Cooperia, tions, removal of foreign bodies, and Nematodirus, Bunostomum, intraocular surgery. Oesophagostomum, Chabertia), and (3) Limitations. Federal law restricts lungworms (Dictyocaulus). this drug to use by or on the order of a (3) Limitations. Conditions of constant licensed veterinarian. helminth exposure may require re- [79 FR 10970, Feb. 27, 2014] treatment within 2 to 4 weeks after the first treatment. Cattle must not be § 524.1204 Kanamycin, amphomycin, slaughtered within 9 days following and hydrocortisone ointment. last treatment. Do not administer to (a) Specifications. Each gram of oint- dairy animals of breeding age. Do not ment contains 5 milligrams kanamycin treat animals before dipping or prior to activity as kanamycin sulfate, 5 milli- exposure to heavy rain. Consult your grams of amphomycin activity as the veterinarian for assistance in the diag- calcium salt, and 10 milligrams of hy- nosis, treatment, and control of para- drocortisone acetate. sitism, and before using in severely de- (b) Sponsor. See No. 054771 in bilitated animals. § 510.600(c) of this chapter. [52 FR 10887, Apr. 6, 1987, as amended at 53 (c) Conditions of use in dogs—(1) FR 7504, Mar. 9, 1988; 62 FR 61626, Nov. 19, Amount. Apply to the affected areas of 1997; 67 FR 78355, Dec. 24, 2002; 79 FR 10970, the skin at least twice daily. In severe Feb. 27, 2014] or widespread lesions it may be desirable to apply the ointment more than § 524.1376 2-Mercaptobenzothiazole so- twice daily. After some improvement is lution. observed, treatment can usually be re- (a) Specifications. The drug contains duced to once daily. 1.3 percent 2-mercaptobenzothiazole in (2) Indications for use. For the treat- a suitable solvent. ment of acute otitis externa, furuncu- (b) Sponsor. See 017135 in § 510.600(c) of losis, folliculitis, pruritus, anal gland this chapter. infections, erythema, decubital ulcers, (c) Conditions of use—(1) Amount. superficial wounds, and superficial ab- Apply twice daily to affected area. scesses associated with bacterial infec- (2) Indications for use. For dogs as an tions caused by organisms susceptible aid in the treatment of hot spots to one or both antibiotics. (moist dermatitis) and as first aid for (3) Limitations. Federal law restricts scrapes and abrasions. this drug to use by or on the order of a (3) Limitations. Clip hair from affected licensed veterinarian. area before applying. If no improve- [79 FR 10970, Feb. 27, 2014] ment is seen within 1 week, consult a veterinarian. § 524.1240 Levamisole. [48 FR 15618, Apr. 12, 1983, as amended at 65 (a) Specifications. The drug contains FR 50913, Aug. 22, 2000; 68 FR 33381, June 4, 200 milligrams of levamisole per milli- 2003]

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§ 524.1443 Miconazole. § 524.1446 Milbemycin otic solution. (a) Specifications. (1) Each gram of (a) Specifications. Each tube contains cream contains miconazole nitrate 0.25 milliliter of a 0.1 percent solution equivalent to 20 milligrams miconazole of milbemycin oxime. base. (b) Sponsor. See No. 058198 in (2) Each gram of lotion or spray con- § 510.600(c) of this chapter. tains miconazole nitrate equivalent to (c) Conditions of use—(1) Amount. One 1 percent miconazole base. tube administered topically into each (b) Sponsors. See § 510.600(c) of this external ear canal. chapter for use as in paragraph (c) of (2) Indications for use. For the treat- this section: ment of ear mite (Otodectes cynotis) in- (1) No. 000061 for use of cream, lotion, festations in cats and kittens 4 weeks and spray; of age and older. Effectiveness is main- (2) Nos. 054925 and 058829 for use of lo- tained throughout the life cycle of the tion and spray. ear mite. (c) Conditions of use in dogs and cats— (3) Limitations. Federal law restricts (1) Amount. Apply once daily by rub- this drug to use by or on the order of a bing into or spraying a light covering licensed veterinarian. on the infected site and the immediate surrounding vicinity. Continue treat- [65 FR 13905, Mar. 15, 2000, as amended at 66 ment for 2 to 4 weeks until infection is FR 13849, Mar. 8, 2001] completely eradicated as determined by appropriate laboratory examina- § 524.1448 Mirtazapine transdermal tion. ointment. (2) Indications for use. For topical (a) Specifications. Each gram of oint- treatment of infections caused by ment contains 20 milligrams (mg) Microsporum canis, Microsporum mirtazapine. gypseum, and Trichophyton (b) Sponsor. See No. 086078 in mentagrophytes. § 510.600(c) of this chapter. (3) Limitations. Federal law restricts (c) Conditions of use—(1) Amount. Ad- this drug to use by or on the order of a minister topically by applying a 1.5 licensed veterinarian. inch ribbon of ointment (approxi- [71 FR 13542, Mar. 16, 2006] mately 2 mg) on the inner pinna of the cat’s ear once daily for 14 days. Alter- § 524.1445 Miconazole, polymixin B, nate the daily application of ointment and prednisolone suspension. between the left and right inner pinna (a) Specifications. Each milliliter of of the ears. suspension contains 23 milligrams (mg) (2) Indications for use. For the man- miconazole nitrate, 0.5293 mg agement of weight loss in cats. polymixin B sulfate, and 5 mg prednis- (3) Limitations. Federal law restricts olone acetate. this drug to use by or on the order of a (b) Sponsor. See No. 058198 in licensed veterinarian. § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) [83 FR 64740, Dec. 18, 2018] Amount. Instill five drops in the ear § 524.1450 Moxidectin. canal twice daily for 7 consecutive days. (a) Specifications. Each milliliter of (2) Indications for use. For the treat- solution contains: ment of canine otitis externa associ- (1) 5 milligrams (mg) moxidectin (0.5 ated with susceptible strains of yeast percent solution). (Malassezia pachydermatis) and bacteria (2) 25 mg moxidectin (2.5 percent so- (Staphylococcus pseudintermedius). lution). (3) Limitations. Federal law restricts (b) Sponsors. See sponsor numbers in this drug to use by or on the order of a § 510.600 of this chapter: licensed veterinarian. (1) No. 000859 for use of product de- [ 75 FR 4693, Jan. 29, 2010, as amended at 77 scribed in paragraph (a)(1) of this sec- FR 46613, Aug. 6, 2012; 81 FR 48703, July 26, tion as in paragraph (d)(1) of this sec- 2016] tion;

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(2) No. 000859 for use of product de- that are at least 7 weeks of age and scribed in paragraph (a)(2) of this sec- that weigh at least 3 lbs. tion as in paragraph (d)(2) of this sec- (iii) Limitations. Federal law restricts tion. this drug to use by or on the order of a (c) Related tolerances. See § 556.426 of licensed veterinarian. this chapter. [63 FR 14036, Mar. 24, 1998, as amended at 65 (d) Conditions of use—(1) Cattle—(i) FR 36617, June 9, 2000; 66 FR 46370, Sept. 5, Amount. Administer topically 0.5 mg 2001. Redesignated at 76 FR 48715, Aug. 9, per kilogram (kg) of body weight. 2011, as amended at 80 FR 53460, Sept. 4, 2015; (ii) Indications for use. Beef and dairy 82 FR 21691, May 10, 2017] cattle: For treatment and control of internal and external parasites: gastro- § 524.1465 Mupirocin. intestinal roundworms (Ostertagia (a) Specifications. Each gram of oint- ostertagi (adult and L4, including inhib- ment contains 20 milligrams ited larvae), Haemonchus placei (adult mupirocin. and L4), Trichostrongylus axei (adult (b) Sponsors. See Nos. 025463, 051672, and L4), T. colubriformis (adult and L4), and 054771 in § 510.600(c) of this chapter. Cooperia oncophora (adult and L4), C. (c) Conditions of use in dogs—(1) pectinata (adult), C. punctata (adult and Amount. Apply twice daily. Treatment L4), C. spatulata (adult), C. surnabada should not exceed 30 days. (adult and L4), Bunostomum (2) Indications for use. For the topical phlebotomum (adult), Oesophagostomum treatment of bacterial infections of the radiatum (adult and L4), Nematodirus skin, including superficial pyoderma, helvetianus (adult and L4)); lungworms caused by susceptible strains of Staphy- (Dictyocaulus viviparus (adult and L4)); lococcus aureus and S. intermedius. cattle grubs (Hypoderma bovis, H. (3) Limitations. Federal law restricts lineatum); mites (Chorioptes bovis, this drug to use by or on the order of a Psoroptes ovis (P. communis var. bovis)); licensed veterinarian. lice (Linognathus vituli, Haematopinus [72 FR 18119, Apr. 11, 2007, as amended at 75 eurysternus, Solenopotes capillatus, FR 79296, Dec. 20, 2010; 78 FR 52854, Aug. 27, Bovicola (Damalinia) bovis); and horn 2013; 79 FR 10970, Feb. 27, 2014; 82 FR 11508, flies (Haematobia irritans). To control Feb. 24, 2017] infections and to protect from reinfection with H. placei for 14 days after § 524.1484 Neomycin ophthalmic and topical dosage forms. treatment, O. radiatum and O. ostertagi for 28 days after treatment, and D. § 524.1484b Neomycin, isoflupredone, viviparus for 42 days after treatment. tetracaine, and myristyl-gamma- (iii) Limitations. A withdrawal period picolinium powder. has not been established for this prod- (a) Specifications. The product con- uct on preruminating calves. Do not tains 5 milligrams of neomycin sulfate, use on calves to be processed for veal. equivalent to 3.5 milligrams of neomy- See § 500.25 of this chapter. cin base, 1 milligram of isoflupredone (2) Dogs—(i) Amount. Administer topi- acetate, 5 milligrams of tetracaine hy- cally a minimum of 1.1 mg per pound drochloride and .2 milligram of (lb) (2.5 mg/kg) of body weight, once myristyl-gamma-picolinium chloride monthly using the appropriate pre- in each gram of the product in a special loaded applicator tube. adherent powder base. (ii) Indications for use. For the pre- (b) Sponsor. See No. 054771 in vention of heartworm disease caused § 510.600(c) of this chapter. by Dirofilaria immitis, as well as the (c) Conditions of use in horses, dogs, treatment and control of intestinal and cats—(1) Amount. Apply to affected hookworm (Ancylostoma caninum areas as a dusting powder. (adult, immature adult, and L4 larvae) (2) Indications for use. For the treat- and Uncinaria stenocephala (adult, im- ment or as adjunctive therapy of cer- mature adult, and L4 larvae)), tain ear and skin conditions caused by roundworm (Toxocara canis (adult and or associated with neomycin-suscep- L4 larvae) and Toxascaris leonina tible organisms and/or allergy; as a su- (adult)), and whipworm (Trichuris vulpis perficial dressing applied to minor (adult)) infections in dogs and puppies cuts, wounds, lacerations, abrasions,

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and for postsurgical application where (3) Limitations. Federal law restricts reduction of pain and inflammatory re- this drug to use by or on the order of a sponse is deemed desirable; as a dust- licensed veterinarian. ing powder following amputation of [40 FR 13873, Mar. 27, 1975, as amended at 43 tails, claws, and dewclaws and fol- FR 18172, Apr. 28, 1978; 79 FR 10970, Feb. 27, lowing ear trimming, castrating, and 2014] such surgical procedures as ovariohysterectomies. For the treat- § 524.1484d Neomycin, hydrocortisone, and tetracaine otic ointment. ment of acute otitis externa, acute moist dermatitis, and interdigital der- (a) Specifications. The product con- matitis in dogs. tains 5 milligrams of neomycin sulfate, equivalent to 3.5 milligrams of neomy- (3) Limitations. Federal law restricts cin base, 5 milligrams of hydro- this drug to use by or on the order of a cortisone acetate, and 5 milligrams of licensed veterinarian. tetracaine hydrochloride in each gram [40 FR 13873, Mar. 27, 1975, as amended at 43 of ointment. FR 18172, Apr. 28, 1978; 79 FR 10970, Feb. 27, (b) Sponsor. See No. 054771 in 2014] § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— § 524.1484c Neomycin, isoflupredone, (1) Amount. Instill a quantity of oint- and tetracaine ointment. ment sufficient to fill the external ear (a) Specifications. The drug contains 5 canal; may be applied one to three milligrams of neomycin sulfate (equiv- times daily. alent to 3.5 milligrams of neomycin (2) Indications for use. For the treatment of ear canker and other inflam- base), 1 milligram of isoflupredone ace- matory conditions of the external ear tate, and 5 milligrams of tetracaine hy- canal, acute otitis externa and, to a drochloride in each gram of ointment. lesser degree, chronic otitis externa. (b) Sponsor. See No. 054771 in (3) Limitations. Federal law restricts § 510.600(c) of this chapter. this drug to use by or on the order of a (c) Conditions of use in dogs—(1) licensed veterinarian. Amount. In treatment of otitis externa [40 FR 13873, Mar. 27, 1975, as amended at 49 and other inflammatory conditions of FR 21922, May 24, 1984; 79 FR 10970, Feb. 27, the external ear canal, a quantity of 2014] ointment sufficient to fill the external ear canal; may be applied one to three § 524.1484e Neomycin and polymyxin B times daily. When used on the skin or ophthalmic solution. mucous membranes, the affected area (a) Specifications. Each milliliter of should be cleansed, and a small amount the ophthalmic preparation contains of the ointment applied and spread or 5.0 milligrams neomycin sulfate (3.5 rubbed in gently. The involved area milligrams neomycin base), and 10,000 may be treated one to three times a Units of polymyxin B sulfate. day and these daily applications con- (b) Sponsor. See No. 054771 in tinued in accordance with the clinical § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) response. Amount. Instill 1 to 2 drops per eye (2) Indications for use. For the treat- every 6 hours. ment of acute otitis externa in dogs (2) Indications for use. For the treat- and to a lesser degree, chronic otitis ment of bacterial infections associated externa in dogs. It also is effective in with topical ophthalmological condi- treating anal gland infections and tions such as corneal injuries, super- moist dermatitis in the dog and is a ficial keratitis, conjunctivitis, useful dressing for minor cuts, lacera- keratoconjunctivitis, and blepharitis. tions, abrasions, and post-surgical (3) Limitations. Federal law restricts therapy in the horse, cat, and dog. It this drug to use by or on the order of a may also be used following amputation licensed veterinarian. of dewclaws, tails and claws, following [40 FR 13873, Mar. 27, 1975, as amended at 61 ear trimming and castrating oper- FR 5507, Feb. 13, 1996; 79 FR 10970, Feb. 27, ations. 2014]

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§ 524.1484f Neomycin, prednisolone, § 524.1484h Neomycin, penicillin, poly- and tetracaine otic suspension. myxin B, and hydrocortisone suspension. (a) Specifications. The product contains 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 milligrams of neomycin, 10,000 inter- acetate, and 5 milligrams of tetracaine national units of penicillin G procaine, hydrochloride in each milliliter of ster- 5,000 international units of polymyxin ile suspension. B sulfate, 2 milligrams of hydro- (b) Sponsor. See No. 054771 in cortisone acetate, and 1.25 milligrams § 510.600(c) of this chapter. of hydrocortisone sodium succinate. (c) Conditions of use in dogs and cats— (b) Sponsor. See No. 054771 in (1) Amount. Instill 2 to 6 drops in the § 510.600(c) of this chapter. external ear canal 2 or 3 times daily. (c) Conditions of use in dogs—(1) (2) Indications for use. For the treat- Amount. Rub a small amount into the ment of acute otitis externa and, to a affected area 1 to 3 times a day. After lesser degree, chronic otitis externa; as definite improvement, apply once daily treatment or adjunctive therapy of cer- or every other day. tain ear conditions caused by or associ- (2) Indications for use. For the treat- ated with neomycin-susceptible orga- ment of summer eczema, atopic dermatitis, interdigital eczema, and otitis nisms and/or allergy. externa caused by bacteria susceptible (3) Limitations. Federal law restricts to neomycin, penicillin, and polymyxin this drug to use by or on the order of a B. licensed 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 10971, Feb. 27, 2014] licensed veterinarian. (d) Conditions of use—dogs—(1) § 524.1484g Neomycin, thiabendazole, Amount. Rub a small amount into the and dexamethasone solution. involved area 1 to 3 times a day. After definite improvement, it may be ap- (a) Specifications. Each milliliter of plied once a day or every other day. solution contains 40 milligrams (mg) (2) Indications for use. Treatment of thiabendazole, 3.2 mg neomycin (from summer eczema, atopic dermatitis, neomycin sulfate), and 1 mg dexa- interdigital eczema, and otitis externa methasone. caused by bacteria susceptible to neo- (b) Sponsors. See Nos. 000010 and mycin, penicillin, and polymyxin B. 026637 in § 510.600(c) of this chapter. (3) Limitations. For use in dogs only. (c) Conditions of use in dogs and cats— Shake drug thoroughly and clean le- (1) Amount. In treating dermatoses af- sion before using. If redness, irritation, fecting areas other than the ear, the or swelling persists or increases, dis- surface of the lesions should be well continue use and reevaluate diagnosis. moistened (2 to 4 drops per square inch) Federal law restricts this drug to use twice daily. In treating otitis externa, by or on the order of a licensed veteri- instill 5 to 15 drops in the ear twice narian. daily. Treat for up to 7 days. [59 FR 5105, Feb. 3, 1994, as amended at 79 FR (2) Indications for use. As an aid in the 10971, Feb. 27, 2014] treatment of bacterial, mycotic, and inflammatory dermatoses and otitis § 524.1484i Neomycin and hydro- externa. cortisone ointment. (3) Limitations. Federal law restricts (a) Specifications. The drug contains 5 this drug to use by or on the order of a milligrams of neomycin sulfate, equiv- licensed veterinarian. alent to 3.5 milligrams of neomycin base, and 5 milligrams of hydro- [40 FR 13873, Mar. 27, 1975, as amended at 62 cortisone acetate in each gram of oint- FR 63271, Nov. 28, 1997; 79 FR 10971, Feb. 27, ment.1 2014; 80 FR 61297, Oct. 13, 2015; 84 FR 39184, (b) Sponsor. See No. 054771 in Aug. 9, 2019] § 510.600(c) of this chapter.

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(c) Conditions of use in dogs and cats— of neomycin sulfate equivalent to 3.5 (1) Amount. Apply 3 or 4 times daily milligrams of neomycin base. into the conjunctival sac. With im- (b) Sponsor. See No. 054771 in provement, frequency may be reduced § 510.600(c) of this chapter. to 2 or 3 times daily. For treatment of (c) Conditions of use in dogs and cats— ear canker and other inflammatory (1) Amount. For beginning treatment of conditions of the external ear canal, acute ocular inflammations place 1 or 2 fill external ear canal 1 to 3 times drops in the conjunctival sac 3 to 6 daily. times during a 24 hour period. When (2) Indications for use. For the treat- improvement occurs, reduce the dosage ment of infections, allergic and trau- to 1 drop 2 to 4 times daily. For otitis matic keratitis, conjunctivitis, acute externa, place 2 to 6 drops in the exter- otitis externa and, to a lesser degree, nal ear canal 2 or 3 times daily. chronic otitis externa. (2) Indications for use. For the treat- (3) Limitations. Federal law restricts ment of treating infectious, allergic this drug to use by or on the order of a and traumatic keratitis and conjunc- licensed veterinarian. tivitis, acute otitis externa, and chron- [43 FR 40456, Sept. 12, 1978, as amended at 79 ic otitis externa. FR 10971, Feb. 27, 2014] (3) Limitations. Federal law restricts this drug to use by or on the order of a § 524.1484j Neomycin and prednisolone licensed veterinarian. ophthalmic ointment. [79 FR 10971, Feb. 27, 2014] (a) Specifications. Each gram of ointment contains prednisolone sodium § 524.1580 Nitrofurazone topical dos- phosphate equivalent to 2.5 milligrams age forms. prednisolone 21-phosphate and 5 milligrams neomycin sulfate equivalent to § 524.1580a Nitrofurazone ointment. 3.5 milligrams neomycin base. (a) Specifications. The drug contains (b) Sponsor. See No. 000010 in 0.2 percent nitrofurazone in a water- § 510.600(c) of this chapter. soluble base. (c) Conditions of use in dogs and cats— (b) Sponsors. See sponsors in (1) Amount. A small quantity of the § 510.600(c) of this chapter. ointment should be expressed into the (1) See Nos. 054925, 058005, 059051, conjunctival sac 4 times a day (at in- 061133, and 069043 for use on dogs, cats, tervals of 1 to 8 hours) for a few days or horses. until there is a favorable response, (2) See No. 017135 for use on dogs and then the frequency of application may horses. be reduced to twice daily as long as the (3) See Nos. 017153 and 058829 for use condition remains under control. on horses. Treatment may require from a few (c) [Reserved] days to several weeks. (d) Conditions of use—(1) Amount. (2) Indications for use. For use in su- Apply directly on the lesion with a perficial ocular inflammations or infec- spatula or first place on a piece of tions limited to the conjunctiva or the gauze. The preparation should remain anterior segment of the eye, such as on the lesion for at least 24 hours. Use those associated with allergic reactions of a bandage is optional. or gross irritants. (2) Indications for use. For prevention (3) Limitations. Federal law restricts or treatment of surface bacterial infec- this drug to use by or on the order of a tions of wounds, burns, and cutaneous licensed veterinarian. ulcers of dogs, cats, or horses. [79 FR 10971, Feb. 27, 2014, as amended at 84 (3) Limitations. For use only on dogs, FR 39184, Aug. 9, 2019] cats, and horses. Do not use on horses intended for human consumption. Fed- § 524.1484k Neomycin and prednis- eral law prohibits the use of this prod- olone suspension. uct in food-producing animals. In case (a) Specifications. Each milliliter of of deep or puncture wounds or serious suspension contains 2.5 milligrams of burns, use only as recommended by prednisolone acetate and 5 milligrams veterinarian. If redness, irritation, or

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swelling persists or increases, dis- on the lesion for at least 24 hours. The continue use; consult veterinarian. dressing may be changed several times [46 FR 43402, June 27, 1980. Redesignated at 79 daily or left on the lesion for a longer FR 10971, Feb. 27, 2014] period. For use only on dogs, cats, and horses (not for food use). In case of EDITORIAL NOTE: For FEDERAL REGISTER ci- deep or puncture wounds or serious tations affecting § 524.1580a, see the List of CFR Sections Affected, which appears in the burns, use only as recommended by a Finding Aids section of the printed volume veterinarian. If redness, irritation, or and at www.govinfo.gov. swelling persists or increases, discontinue use; consult veterinarian. § 524.1580b Nitrofurazone soluble powder. [49 FR 9417, Mar. 13, 1984, as amended at 71 FR 13542, Mar. 16, 2006. Redesignated at 79 FR (a) Specifications. The drug contains 10971, Feb. 27, 2014; 79 FR 10971, Feb. 27, 2014] 0.2 percent nitrofurazone in a water- soluble base. § 524.1600 Nystatin ophthalmic and (b) Sponsor. See Nos. 059051 and 069043 topical dosage forms. in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. § 524.1600a Nystatin, neomycin, Apply several times daily to the lesion thiostrepton, and triamcinolone or affected area from the plastic ointment. squeeze bottle. (a) Specifications. Each milliliter of (2) Indications for use. For prevention petrolatum base or each gram of van- or treatment of surface bacterial infec- ishing cream base ointment contains: tions of wounds, burns, skin ulcers, and 100,000 units of nystatin; neomycin sul- abscesses after incision. fate equivalent to 2.5 milligrams of ne- (3) Limitations. In case of deep or omycin base; 2,500 units of puncture wounds or serious burns, use thiostrepton; and 1.0 milligram of only as recommended by veterinarian. triamcinolone acetonide. If redness, irritation, or swelling persists or increases, discontinue use; con- (b) Sponsors. For petrolatum base sult veterinarian. For use only on dogs, ointments see Nos. 000856, 025463, 054771, cats, and horses (not for food use). and 054925 in § 510.600(c) of this chapter. For vanishing cream base ointments [45 FR 43402, June 27, 1980, as amended at 47 see Nos. 025463, 054771, and 054925. FR 43368, Oct. 1, 1982; 48 FR 28984, June 24, 1983; 53 FR 40728, Oct. 18, 1988; 54 FR 30542, (c) Conditions of use—(1) Amount. (i) July 21, 1989; 56 FR 50653, Oct. 8, 1991; 59 FR For topical dermatological use: Clean 33197, June 28, 1994; 60 FR 55659, Nov. 2, 1995; affected areas and remove any en- 62 FR 35077, June 30, 1997; 76 FR 17778, Mar. crusted discharge or exudate, and apply 31, 2011; 78 FR 21060, Apr. 9, 2013. Redesig- sparingly either ointment in a thin nated at 79 FR 10971, Feb. 27, 2014, as amend- film. ed at 79 FR 64117, Oct. 28, 2014; 83 FR 48947, Sept. 28, 2018] (ii) For otic use: Clean ear canal of impacted cerumen, remove any foreign § 524.1580c Nitrofurazone and buta- bodies such as grass awns and ticks, caine ointment. and instill three to five drops of petro- (a) Specifications. The drug contains latum base ointment. Preliminary use 0.2 percent nitrofurazone and 0.5 per- of a local anesthetic may be advisable. cent butacaine sulfate in a water-solu- (iii) For infected anal glands and cys- ble base. tic areas: Drain gland or cyst and fill (b) Sponsor. See No. 054925 in with petrolatum base ointment. § 510.600(c) of this chapter. (2) Indications for use. (i) Topically: (c) Conditions of use—(1) Indications Use either ointment in dogs and cats for use. For prevention or treatment of for anti-inflammatory, antipruritic, surface bacterial infections of ears, antifungal, and antibacterial treat- wounds, burns, and cutaneous ulcers of ment of superficial bacterial infec- dogs, cats, and horses. tions, and for dermatologic disorders (2) Limitations. Apply directly on the characterized by inflammation and dry lesion with a spatula or first place on a or exudative dermatitis, particularly piece of gauze. Use of a bandage is op- associated with bacterial or candidal tional. The preparation should remain (Candida albicans) infections.

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(ii) Otitis, cysts, and anal gland in- § 524.1610 Orbifloxacin, mometasone fections: Use petrolatum base ointment furoate monohydrate, and in dogs and cats for the treatment of posaconazole suspension. acute and chronic otitis and interdig- (a) Specifications. Each gram of sus- ital cysts, and in dogs for anal gland pension contains 10 milligrams (mg) infections. orbifloxacin, mometasone furoate (3) Limitations. Federal law restricts monohydrate equivalent to 1 mg this drug to use by or on the order of a mometasone furoate, and 1 mg licensed veterinarian. posaconazole. (b) Sponsor. See No. 000061 in [40 FR 13873, Mar. 27, 1975, as amended at 43 § 510.600(c) of this chapter. FR 29770, July 11, 1978; 50 FR 41490, Oct. 11, (c) Conditions of use in dogs—(1) 1985; 53 FR 39257, Oct. 6, 1988; 54 FR 5431, Feb. 3, 1989; 54 FR 48090, Nov. 21, 1989; 56 FR 50653, Amount. For dogs weighing less than 30 Oct. 8, 1991; 60 FR 55660, Nov. 2, 1995; 61 FR lbs. instill 4 drops once daily into the 63712, Dec. 2, 1996; 64 FR 42831, Aug. 6, 1999; 67 ear canal. For dogs weighing 30 lbs. or FR 67521, Nov. 6, 2002; 68 FR 55201, Sept. 23, more, instill 8 drops into the ear canal. 2003; 70 FR 50183, Aug. 26, 2005; 71 FR 13542, Therapy should continue for 7 consecu- Mar. 16, 2006; 79 FR 10972, Feb. 27, 2014] tive days. (2) Indications for use. For the treat- § 524.1600b Nystatin, neomycin, ment of otitis externa associated with thiostrepton, and triamcinolone susceptible strains of yeast (Malassezia ophthalmic ointment. pachydermatis) and bacteria (coagulase- (a) Specifications. Each cubic centi- positive staphylococci, Pseudomonas meter of ointment contains: 100,000 aeruginosa, and Enterococcus faecalis). units of nystatin, neomycin sulfate (3) Limitations. Federal law restricts equivalent to 2.5 milligrams of neomy- this drug to use by or on the order of a cin base, 2,500 units of thiostrepton, licensed veterinarian. and 1.0 milligram of triamcinolone [75 FR 16346, Apr. 1, 2010] acetonide. (b) Sponsor. See No. 053501 in § 524.1662 Oxytetracycline ophthalmic § 510.600(c) of this chapter. and topical dosage forms. (c) Related tolerances. See §§ 556.430 and 556.470 of this chapter. § 524.1662a Oxytetracycline and hydrocortisone spray. (d) Conditions of use—(1) Dogs and cats—(i) Amount. Apply 1 drop of oint- (a) Specifications. Each 3-ounce unit ment to the affected eye(s) 2 or 3 times of oxytetracycline hydrochloride and daily. Treatment may be continued for hydrocortisone spray contains 300 mil- up to 2 weeks if necessary. ligrams of oxytetracycline hydro- (ii) Indications for use. For use as an chloride and 100 milligrams of hydro- anti-inflammatory, antipruritic, cortisone with an inert freon propel- antifungal (Candida albicans), and anti- lant such that a 1-second spray treat- bacterial ointment for local therapy in ment will deliver approximately 2.5 keratitis and conjunctivitis. milligrams of oxytetracycline hydro- (iii) Limitations. Federal law restricts chloride and 0.8 milligram of hydro- this drug to use by or on the order of a cortisone. licensed veterinarian. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (2) Cattle—(i) Amount. Apply small (c) Conditions of use in dogs and cats— line of ointment to the affected eye(s) (1) Amount. A small quantity should be once daily. Treatment may be contin- sprayed on the affected surface by ued for up to 2 weeks if necessary. holding the container about 6 inches (ii) Indications for use. For infectious from the area to be treated and press- kerato-conjunctivitis (pinkeye). ing the nozzle for 1 or 2 seconds. Only (iii) Limitations. Federal law restricts sufficient spray to coat the skin thinly this drug to use by or on the order of a is necessary. The application of small licensed veterinarian. amounts at frequent intervals will give [40 FR 13873, Mar. 27, 1975, as amended at 50 best results. Before treating animals FR 41490, Oct. 11, 1985; 79 FR 10972, Feb. 27, with long or matted hair, it may be 2014; 84 FR 32993, July 11, 2019] necessary to clip the affected area or

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spread the hairs to allow the medica- sitive bacteria or fungi appear during tion to contact the skin surface. Relief therapy, appropriate measures should may be noted following the first or sec- be taken. ond treatment; however, treatment [40 FR 13873, Mar. 27, 1975, as amended at 79 should not be discontinued too soon FR 10972, Feb. 27, 2014] after the initial favorable response has been obtained. § 524.1742 Phosmet emulsifiable liquid. (2) Indications for use. For the relief of (a) Specifications. The emulsifiable discomfort and continued treatment of liquid contains 11.6 percent N- many allergic, infectious, and trau- (mercaptomethyl) phthalimide S-(O,O- matic skin conditions; for the preven- dimethyl phosphorodithioate). tion of bacterial infections in super- (b) Sponsor. See No. 000061 in ficial wounds, cuts, and abrasions, § 510.600(c) of this chapter. treatment of allergic dermatoses, in- (c) Related tolerances. See 40 CFR cluding urticaria, eczemas, insect 180.261. bites, and cutaneous drug reactions, in- (d) Conditions of use—(1) Methods of fections associated with minor burns application. Methods of application to and wounds, and nonspecific pruritus. control the following conditions on (3) Limitations. Keep away from eyes beef cattle: or other mucous membranes; avoid inhaling; use with adequate ventilation; TABLE 1 TO PARAGRAPH (d)(1) in case of deep or puncture wounds or serious burns, consult a veterinarian. Dilution rate To control/method of use (gal. drug: gal. [40 FR 13873, Mar. 27, 1975, as amended at 79 of water) FR 10972, Feb. 27, 2014] Grubs: Dip ...... 1:60 § 524.1662b Oxytetracycline and poly- Pour-on ...... 1:2 myxin B ophthalmic ointment. Spray ...... 1:49 Lice: (a) Specifications. Each gram of the Dip ...... 1:60 ointment contains oxytetracycline hy- Pour-on ...... 1:2 or 1:5 Spray ...... 1:49 or 1:100 drochloride equivalent to 5 milligrams Hornflies: of oxytetracycline and 10,000 units of Dip ...... 1:60 polymyxin B sulfate. Spray ...... 1:49 or 1:100 Cattle Ticks: (b) Sponsor. See No. 054771 in Dip ...... 1:60 or 1:240 § 510.600(c) of this chapter. Spray ...... 1:49 (c) Conditions of use in dogs and cats— Southern cattle ticks: Dip ...... 1:60 or 1:240 (1) Amount. Administer topically to the Spray ...... 1:49 eye two to four times daily. Scabies mites:. (2) Indications for use. For the prophy- Dip ...... 1:60 laxis and local treatment of superficial Lone Star Ticks: Dip ...... 1:60 ocular infections due to Spray ...... 1:49 or 1:100 oxytetracycline- and polymyxin-sensitive organisms including ocular in- (i) Dip vat procedure. (A) Prior to fections due to streptococci, charging vat, empty old contents and rickettsiae, E. coli, and A. aerogenes thoroughly clean the vat. Dip vats (such as conjunctivitis, keratitis, pink- should be calibrated to maintain an ac- eye, corneal ulcer, and blepharitis in curate dilution. Add water, then drug dogs, cats, cattle, sheep, and horses); to the vat according to the dilution ocular infections due to secondary bac- rate indicated in the table. Add super terial complications associated with phosphate at a rate of 100 pounds per distemper in dogs; and ocular infec- 1,000 gallons of vat solution. Super tions due to bacterial inflammatory phosphate is added to control the pH of conditions which may occur secondary the solution and ensure vat stability. to other infectious diseases in dogs, Super phosphate is usually available at cats, cattle, sheep, and horses. most fertilizer dealers as 0–45–0 or 0–46– (3) Limitations. Allergic reactions 0. Stir the dip thoroughly, preferably may occasionally occur. Treatment with a compressed air device; however, should be discontinued if reactions are any form of thorough mixing is ade- severe. If new infections due to nonsen- quate. Re-stir vat contents prior to

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each use. During the dipping operation, gullet or spinal canal, as the rapid kill each time the dip’s volume is reduced of large numbers of larvae in these tis- by 1⁄8 to 1⁄4 of its initial volume, replen- sues may cause toxic side effects, such ish with water and add the drug at a as bloat, salivation, staggering, and parate of 1 gallon for each 50 or 200 gal- ralysis. lons water added—depending on dilu- (3) Treatment regimens. (i) Control of tion rate 1:60 or 1:240. Also add super scabies mites requires two treatments, phosphate as necessary to maintain pH 10 to 14 days apart. between 4.5 and 6.5. Stir well and re- (ii) Control of Lone Star Ticks and sume dipping. Repeat replenishment hornflies requires two treatments, 7 process as necessary. For evaportion, days apart. add additional water accordingly. For (4) Warnings. The drug is a cholin- added water due to rainfall, merely re- esterase inhibitor. Do not use this drug plenish dip with the product according on animals simultaneously or within a to directions. If overflow occurs, either few days before or after treatment with analyze for drug concentration and ad- or exposure to cholinesterase-inhib- just accordingly or dispose of vat con- iting drugs, pesticides, or chemicals. tents and recharge. Check pH after Do not apply within 21 days of slaugh- each addition of water or super phos- ter. For use on beef cattle only. Do not phate to assure proper pH controls. treat sick, convalescent, or stressed (B) Dip maintenance. (1) With use of cattle, or calves less than 3 months old dip vat tester, dipping may continue as except in Federal or State eradication long as the drug concentration is main- programs where immediate treatment tained between 0.15 and 0.25 percent, of all animals in an infested herd is and the dip is not too foul for satisfac- mandatory. Be sure free access to tory use as indicated by foul odor or drinking water is available to cattle excessive darkening (i.e., color changes prior to dipping. Do not dip excessively from beige to very dark brown). thirsty animals. Do not dip animals (2) Without use of dip vat tester, vat when overheated. Repeat treatment as should be emptied, cleaned, and re- necessary but not more often than charged each time one of the following every 7 to 10 days. Treatment for lice, occurs: When the dip has been charged ticks, hornflies, and scabies mites may for 120 days; when the dip becomes too be made any time of the year except foul for satisfactory use, within the when cattle grub larvae are in the gul- 120-day limit; if the number of animals let or spinal canal. Treatment for lice, dipped equals twice the number of gal- ticks, and scabies mites may be made lons of the initial dip volume, within any time 7 to 10 days following treat- the 120-day limit. ment for grubs. Do not treat grubs (ii) Spray method. To prepare the when the grub larvae are in the gullet spray, mix drug with water according or spinal canal. Do not get in eyes, on to table and stir thoroughly. Apply the skin, or on clothing. Do not breathe fresh mixture as a high-pressure spray, spray mist. Wear rubber gloves, gog- taking care to wet the skin, not just gles, and protective clothing. In case of the hair. Apply to the point of ‘‘run- skin contact, wash immediately with off,’’ about 1 gallon of diluted spray per soap and water; for eyes, flush with adult animal. Lesser amounts will per- water. Wash all contaminated clothing mit runoff for younger animals. with soap and hot water before re-use. (iii) Pour-on method. Dilute the drug [40 FR 13873, Mar. 27, 1975, as amended at 46 with water according to table by slow- FR 27914, May 22, 1981; 48 FR 39607, Sept. 1, ly adding water to the product while 1983; 54 FR 51021, Dec. 12, 1989; 61 FR 8873, stirring. Apply 1 ounce of the diluted Mar. 6, 1996; 62 FR 61626, Nov. 19, 1997; 63 FR mixture per 100 pounds of body weight 5255, Feb. 2, 1998; 85 FR 18120, Apr. 1, 2020] (to a maximum of 8 ounces per head) down the center line of the back. § 524.1982 Proparacaine ophthalmic (2) Timing of applications for cattle solution. grub control. For optimum cattle grub (a) Specifications. The drug is an aque- control, it is important to treat as ous solution containing 0.5 percent soon as possible after the heel fly sea- proparacaine hydrochloride, 2.45 person, before the grub larvae reach the cent glycerin as a stabilizer, and 0.2

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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 (b) Sponsor. See No. 054771 in minor surgery, and prior to catheter- § 510.600(c) of this chapter. ization. (c) Conditions of use in dogs and cats— (2) It is administered as follows: (1) Amount. It is administered as fol- (i) For removal of sutures: Instill one lows: to two drops 2 or 3 minutes before re- (i) For removal of sutures: Instill one moval of stitches. to two drops 2 or 3 minutes before re- (ii) For removal of foreign bodies moval of stitches. from eye, ear, and nose: For oph- (ii) For removal of foreign bodies thalmic use, instill three to five drops from eye, ear, and nose: For oph- in the eye prior to examination; for thalmic use, instill three to five drops otic use, instill five to 10 drops in the in the eye prior to examination; for ear; for nasal use, instill five to 10 otic use, instill five to ten drops in the drops in each nostril every 3 minutes ear; for nasal use, instill five to ten for three doses. drops in each nostril every 3 minutes (iii) For tonometry: Instill one to for three doses. two drops immediately before measure- (iii) For tonometry: Instill one to ment. two drops immediately before measure- (iv) As an aid in treatment of otitis: ment. Instill two drops into the ear every 5 (iv) As an aid in treatment of otitis: minutes for three doses. Instill two drops into the ear every 5 (v) For minor surgery: Instill one or minutes for three doses. more drops as required. (v) For minor surgery: Instill one or (vi) For catheterization: Instill two more drops as required. to three drops with a blunt 20-gauge (vi) For catheterization: Instill two needle immediately before inserting to three drops with a blunt 20-gauge catheter. needle immediately before inserting (3) For use only by or on the order of catheter. a licensed veterinarian. (2) Indications for use. For use as a topical ophthalmic anesthetic. It is [40 FR 13873, Mar. 27, 1975, as amended at 50 used as an anesthetic in cauterization FR 41490, Oct. 11, 1985; 79 FR 10972, Feb. 27, of corneal ulcers, removal of foreign 2014] bodies and sutures from the cornea, § 524.2098 Selamectin. and measurement of intraocular pressure (tonometry) when glaucoma is (a) Specifications. Each milliliter con- suspected; as an aid in the removal of tains 60 or 120 milligrams of foreign bodies from the nose and ear selamectin. canal; as an accessory in the examina- (b) Sponsor. See Nos. 054771 and 055529 tion and treatment of painful otitis, in in § 510.600(c) of this chapter. minor surgery, and prior to catheter- (c) [Reserved] ization. (d) Conditions of use—(1) Amount. 2.7 (3) Limitations. Keep away from eyes milligrams of selamectin, topically, or other mucous membranes; avoid in- per pound (6 milligrams per kilogram) haling; use with adequate ventilation; of body weight. in case of deep or puncture wounds or (2) Indications for use. Kills adult fleas serious burns, consult a veterinarian. and prevents flea eggs from hatching (d) Conditions of use. (1) The drug is for 1 month, and it is indicated for the indicated for use as a topical oph- prevention and control of flea infesta- thalmic anesthetic in animals. It is tions (Ctenocephalides felis), prevention used as an anesthetic in cauterization of heartworm disease caused by of corneal ulcers, removal of foreign Dirofilaria immitis, and treatment and bodies and sutures from the cornea, control of ear mite (Otodectes cynotis) and measurement of intraocular pres- infestations in dogs and cats. Treat- sure (tonometry) when glaucoma is ment and control of sarcoptic mange suspected. Local applications may also (Sarcoptes scabiei) and control of tick be used as an aid in the removal of for- (Dermacentor variabilis) infestations in

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dogs. Treatment and control of intes- selenium disulfide (1-percent weight in tinal hookworm (Ancylostoma volume (w/v)). tubaeforme) and roundworm (Toxocara (b) Sponsors. See Nos. 000010, 000061, cati) infections in cats. For dogs 6 and 017135 in § 510.600(c) of this chapter. weeks of age and older, and cats 8 (c) Conditions of use on dogs—(1) Indi- weeks of age and older. cations for use. For use as a cleansing (3) Limitations. Federal law restricts shampoo and as an agent for removing this drug to use by or on the order of a skin debris associated with dry eczema, licensed veterinarian. seborrhea, and nonspecific dermatoses. (2) Amount. One to 2 ounces per appli- [64 FR 37401, July 12, 1999, as amended at 64 FR 48707, Sept. 8, 1999; 65 FR 45282, July 21, cation. 2000; 74 FR 19878, Apr. 30, 2009; 79 FR 10972, (3) Limitations. Use carefully around Feb. 27, 2014; 85 FR 18120, Apr. 1, 2020] scrotum and eyes, covering scrotum with petrolatum. Allow the shampoo to § 524.2099 Selamectin and sarolaner. remain for 5 to 15 minutes before thor- (a) Specifications. Each milliliter ough rinsing. Repeat treatment once or (mL) of solution contains 60 milligrams twice a week. If conditions persist or if (mg) selamectin and 10 mg sarolaner. rash or irritation develops, discontinue The drug is provided in single dose use and consult a veterinarian. tubes containing 0.25, 0.5, or 1 mL of so- [47 FR 53351, Nov. 26, 1982, as amended at 48 lution. FR 32762, July 19, 1983; 54 FR 36962, Sept. 6, (b) Sponsor. See No. 054771 in 1989; 56 FR 9623, Mar. 7, 1991; 58 FR 41025, § 510.600(c) of this chapter. Aug. 2, 1993; 63 FR 26981, May 15, 1998; 70 FR (c) Conditions of use in cats—(1) 50183, Aug. 26, 2005; 84 FR 39184, Aug. 9, 2019] Amount. Administer 2.7 mg selamectin § 524.2350 Tolnaftate cream. per pound (/lb) (6 mg per kilogram (/ kg)) of body weight and 0.45 mg/lb (a) Specifications. The drug contains 1 sarolaner (1 mg/kg) by emptying the percent tolnaftate in an anhydrous contents of the tube on the back of the cream base. animal at the base of the neck in front (b) Sponsor. See No. 000061 in of the shoulder blades. § 510.600(c) of this chapter. (2) Indications for use. For the preven- (c) Conditions of use—(1) Amount. tion of heartworm disease caused by Apply a small amount of the cream to Dirofilaria immitis. Kills adult fleas the affected areas once or twice a day (Ctenocephalides felis) and is indicated for 2 to 4 weeks. for the treatment and prevention of (2) Indications for use. For the treat- flea infestations; the treatment and ment of ringworm lesions due to control of tick infestations with Ixodes Microsporum canis and Microsporum scapularis (black-legged or deer tick), gypseum. Amblyomma maculatum (Gulf Coast (3) Limitations. Federal law restricts tick), and Dermacentor variabilis (Amer- this drug to use by or on the order of a ican dog tick); the treatment and con- licensed veterinarian. trol of ear mite (Otodectes cynotis) in- [79 FR 10972, Feb. 27, 2014] festations; and the treatment and control of roundworm (Toxocara cati) and § 524.2482 Triamcinolone spray. intestinal hookworm (Ancylostoma (a) Specifications. Each milliliter of tubaeforme) infections in cats and kit- solution contains 0.15 milligrams tens 8 weeks of age and older, and triamcinolone acetonide. weighing 2.8 pounds or greater. (b) Sponsor. See No. 051311 in (3) Limitations. Federal law restricts § 510.600(c) of this chapter. this drug to use by or on the order of a (c) Conditions of use in dogs—(1) licensed veterinarian. Amount. Apply sufficient pump sprays [84 FR 12494, Apr. 2, 2019] to uniformly and thoroughly wet the affected areas while avoiding run off of § 524.2101 Selenium disulfide suspen- excess product. Administer twice daily sion. for 7 days, then once daily for 7 days, (a) Specifications. The product con- then every other day for an additional tains 0.9-percent weight in weight (w/w) 14 days (28 days total).

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(2) Indications for use. For the control PART 526—INTRAMAMMARY DOS- of pruritus associated with allergic der- AGE FORM NEW ANIMAL matitis. DRUGS (3) Limitations. Federal law restricts this drug to use by or on the order of a Sec. licensed veterinarian. 526.88 Amoxicillin trihydrate for intramammary infusion. [68 FR 4916, Jan. 31, 2003, as amended at 78 526.313 Ceftiofur. FR 17868, Mar. 25, 2013] 526.363 Cephapirin benzathine. 526.365 Cephapirin sodium. § 524.2483 Triamcinolone cream. 526.464 Cloxacillin intramammary dosage (a) Specifications. The vanishing forms. 526.464a Cloxacillin benzathine. cream contains 0.1 percent 526.464b Cloxacillin sodium for triamcinolone acetonide. intramammary infusion, sterile. (b) Sponsor. See Nos. 000010 and 054925 526.820 Erythromycin. in § 510.600(c) of this chapter. 526.1130 Hetacillin. (c) Conditions of use in dogs—(1) 526.1590 Novobiocin infusion. 526.1696 Penicillin intramammary dosage Amount. Rub into affected areas two to forms. four times daily for 4 to 10 days. 526.1696a Penicillin G procaine. (2) Indications for use. For topical 526.1696b Penicillin G procaine-dihydro- treatment of allergic dermatitis and streptomycin in soybean oil for summer eczema. intramammary infusion (dry cows). (3) Limitations. Federal law restricts 526.1696c Penicillin G procaine-dihydrostreptomycin sulfate for intramammary this drug to use by or on the order of a infusion (dry cows). licensed veterinarian. 526.1696d Penicillin G procaine-novobiocin for intramammary infusion. [71 FR 13542, Mar. 16, 2006, as amended at 73 526.1810 Pirlimycin. FR 79318, Dec. 29, 2008. Redesignated and amended at 75 FR 10168, Mar. 5, 2010; 77 FR AUTHORITY: 21 U.S.C. 360b. 60302, Oct. 3, 2012] § 526.88 Amoxicillin trihydrate for § 524.2620 Liquid crystalline trypsin, intramammary infusion. Peru balsam, castor oil. (a) Specifications. Each single dose sy- (a) Specifications. (1) Each gram of liq- ringe contains amoxicillin trihydrate uid or aerosol contains 0.12 milligram equivalent to 62.5 milligrams of of crystalline trypsin, 87.0 milligrams amoxicillin. (b) Sponsor. See No. 000061 in of Peru balsam, and 788.0 milligrams of § 510.600(c) of this chapter. castor oil. (c) Related tolerances. See § 556.38 of (2) Each gram of liquid or aerosol this chapter. contains 0.1 milligram of crystalline (d) Conditions of use—Lactating cows— trypsin, 72.5 milligrams of Peru bal- (1) Amount. One syringe (equivalent to sam, and 800 milligrams of castor oil. 62.5 milligrams amoxicillin) per quar- (b) Sponsors. See sponsor numbers in ter. § 510.600(c) of this chapter for use as in (2) Indications for use. For the treat- paragraph (c) in this section: ment of subclinical infectious bovine (1) No. 051079 for use of product de- mastitis due to Streptococcus agalactiae scribed in paragraph (a)(1). and Straphylococcus aureus (penicillin (2) No. 017135 for use of product de- sensitive). scribed in paragraph (a)(2). (3) Limitations. Administer after (c) Conditions of use—(1) Amount. milking. Clean and disinfect the teat. Apply directly to the wound site. Use one syringe per infected quarter (2) Indications for use. As an aid in the every 12 hours for a maximum of 3 treatment of external wounds and as- doses. Do not use milk taken from sists healing by facilitating the retreated animals for food purposes with- moval of necrotic tissue, exudate, and in 60 hours (5 milkings) after last treatment. Do not slaughter treated ani- organic debris. mals for food purposes within 12 days [79 FR 10973, Feb. 27, 2014] after the last treatment. Federal law

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restricts this drug to use by or on the (iii) Limitations. Milk taken from order of a licensed veterinarian. cows completing a 30-day dry-off period may be used for food with no milk dis- [57 FR 37334, Aug. 18, 1992, as amended at 60 FR 55660, Nov. 2, 1995; 68 FR 44878, July 31, card due to ceftiofur residues. Fol- 2003] lowing intramammary infusion, a 16- day preslaughter withdrawal period is § 526.313 Ceftiofur. required for treated cows. Following (a) Specifications. Each single-use, 10- label use, no preslaughter withdrawal milliliter syringe of ceftiofur hydro- period is required for neonatal calves chloride suspension contains 125 milli- from treated cows regardless of colos- grams (mg) or 500 mg ceftiofur equiva- trum consumption. Federal law re- lents. stricts this drug to use by or on the (b) Sponsor. See No. 054771 in order of a licensed veterinarian. Fed- § 510.600(c) of this chapter. eral law prohibits extra-label use of (c) Related tolerances. See § 556.113 of this drug in dry dairy cattle for disease this chapter. prevention purposes; at unapproved (d) Conditions of use in cattle—(1) Lac- doses; frequencies, durations, or routes tating cows—(i) Amount. Infuse 125 mg of administration; and in unapproved per affected quarter. Repeat treatment major food producing species/produc- in 24 hours. Once daily treatment may tion classes. be repeated for up to 8 consecutive [70 FR 9516, Feb. 28, 2005, as amended at 70 days. FR 20048, Apr. 18, 2005. Redesignated and (ii) Indications for use. For use in lac- amended at 71 FR 39545, July 13, 2006; 79 FR tating dairy cattle: 10973, Feb. 27, 2013; 79 FR 18159, Apr. 1, 2014; (A) For the treatment of clinical 80 FR 34279, June 16, 2015] mastitis associated with coagulase- negative staphylococci, Streptococcus § 526.363 Cephapirin benzathine. dysgalactiae, and Escherichia coli; and (a) Specifications. Each 10 milliliter (B) For the treatment of diagnosed disposable syringe contains 300 milli- subclinical mastitis associated with grams of cephapirin activity (as coagulase-negative staphylococci and cephapirin benzathine) in a peanut-oil S. dysgalactiae. gel. (iii) Limitations. Milk taken from (b) Sponsor. See No. 000010 in cows during treatment (a maximum of § 510.600(c) of this chapter. eight daily infusions) and for 72 hours (c) Related tolerances. See § 556.115 of after the last treatment must not be this chapter. used for human consumption. Fol- (d) Conditions of use—(1) Amount. In- lowing label use for up to 8 consecutive fuse the contents of one syringe into days, a 2-day preslaughter withdrawal each quarter. period is required. Federal law restricts (2) Indications for use. Use in dry cows this drug to use by or on the order of a for treatment of mastitis caused by licensed veterinarian. Federal law prohibits extra-label use of this drug in susceptible strains of Streptococcus lactating dairy cattle for disease pre- agalactiae and Staphylococcus aureus, vention purposes; at unapproved doses; including penicillin-resistant strains. frequencies, durations, or routes of ad- (3) Limitations. Infuse each quarter ministration; and in unapproved major following last milking, but no later food producing species/production than 30 days before calving. Milk from classes. treated cows must not be used for food (2) Dry cows—(i) Amount. Infuse 500 during the first 72 hours after calving. mg per affected quarter at the time of Animals infused with this product dry off. must not be slaughtered for food until (ii) Indications for use. For the treat- 42 days after the latest infusion. For ment of subclinical mastitis in dairy use in dry cows only. cattle at the time of dry off associated [43 FR 37174, Aug. 22, 1978, as amended at 53 with Staphylococcus aureus, Strepto- FR 27851, July 25, 1988; 73 FR 12262, Mar. 7, coccus dysgalactiae, and Streptococcus 2008; 75 FR 10168, Mar. 5, 2010; 76 FR 17338, uberis. Mar. 29, 2011]

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§ 526.365 Cephapirin sodium. calving. Animals infused with this (a) Specifications. Each 10-milliliter product must not be slaughtered for food use for 30 days after the latest in- dose contains 200 milligrams of fusion. Federal law restricts this drug cephapirin sodium activity in a peanut- to use by or on the order of a licensed oil gel. veterinarian. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. [57 FR 37334, Aug. 18, 1992; 57 FR 42623, Sept. (c) Related tolerances. See § 556.115 of 15, 1992, as amended at 60 FR 55660, Nov. 2, this chapter. 1995; 75 FR 10168, Mar. 5, 2010; 75 FR 71017, (d) Conditions of use in lactating Nov. 22, 2010; 79 FR 10973, Feb. 27, 2014] cows—(1) Amount. Infuse one dose into § 526.464b Cloxacillin sodium for each infected quarter immediately intramammary infusion, sterile. after the quarter has been completely milked out. Do not milk out for 12 (a) Specifications. Each milliliter con- hours. Repeat once only in 12 hours. tains cloxacillin sodium equivalent to (2) Indications for use. For the treat- 20.0 milligrams of cloxacillin. ment of mastitis in lactating cows (b) Sponsor. See No. 000061 in caused by susceptible strains of Strepto- § 510.600(c) of this chapter. coccus agalactiae and Staphylococcus (c) Related tolerances. See § 556.165 of aureus including strains resistant to this chapter. penicillin. (d) Conditions of use. Lactating cows— (3) Limitations. If improvement is not (1) Amount. 10 milliliters (one dose of noted within 48 hours after treatment, 200 milligrams) per infected quarter. consult your veterinarian. Milk that (2) Indications for use. Treatment of has been taken from animals during mastitis in lactating cows due to Strep- treatment and for 96 hours after the tococcus agalactiae and Staphylococcus last treatment must not be used for aureus, nonpenicillinase-producing food. Treated animals must not be strains. (3) Limitations. Administer after slaughtered for food until 4 days after milking, cleaning, and disinfecting, the last treatment. and as early as possible after detection. [40 FR 57455, Dec. 10, 1975, as amended at 53 Treatment should be repeated at 12- FR 27852, July 25, 1988. Redesignated at 63 FR hour intervals for a total of three 8349, Feb. 19, 1998; 65 FR 20733, Apr. 18, 2000; doses. Milk taken from treated animals 73 FR 3181, Jan. 17, 2008; 75 FR 10168, Mar. 5, within 48 hours (four milkings) after 2010] the latest treatment should not be used § 526.464 Cloxacillin intramammary for food. Treated animals should not be dosage forms. slaughtered for food within 10 days after the latest treatment. Federal law § 526.464a Cloxacillin benzathine. restricts this drug to use by or on the (a) Specifications. Each dose contains order of a licensed veterinarian. cloxacillin benzathine equivalent to 500 [57 FR 37335, Aug. 18, 1992, as amended at 60 milligrams of cloxacillin. FR 55660, Nov. 2, 1995; 68 FR 44878, July 31, (b) Related tolerances. See § 556.165 of 2003. Redesignated at 85 FR 18120, Apr. 1, this chapter. 2020] (c) Sponsor. See No. 000010 in § 510.600(c) of this chapter for use in § 526.820 Erythromycin. dairy cows. (a) Specifications. (1) Each 6-milliliter, (1) Amount. Administer aseptically single-dose, disposable syringe con- into each quarter immediately after tains 300 milligrams of erythromycin last milking. (as the base), 0.45 milligram of (2) Indications for use. For the treat- butylated hydroxyanisole, and 0.45 mil- ment of mastitis caused by Staphy- ligram of butylated hydroxytoluene. lococcus aureus and Streptococcus (2) Each 12-milliliter, single-dose, dis- agalactiae including penicillin resistant posable syringe contains 600 milligrams strains in dairy cows during the dry pe- of erythromycin (as the base), 0.90 mil- riod. ligram of butylated hydroxyanisole, (3) Limitations. For use in dry cows and 0.90 milligram of butylated hy- only. Not to be used within 30 days of droxytoluene.

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(3) The vehicle is triglyceride of satu- latest treatment must not be used for rated fatty acids from coconut oil. food. Treated animals must not be (4) The drug may or may not be ster- slaughtered for food until 10 days after ile. the latest treatment. Federal law re- (b) Sponsor. See Nos. 054771 and 061133 stricts this drug to use by or on the in § 510.600(c) of this chapter. order of a licensed veterinarian. (c) Related tolerances. See § 556.230 of this chapter. [57 FR 37335, Aug. 18, 1992, as amended at 75 FR 10168, Mar. 5, 2010; 84 FR 53311, Oct. 7, (d) Conditions of use—(1) Amount. (i) 2019] Lactating cows: After milking, cleaning, and disinfecting, infuse contents of § 526.1590 Novobiocin infusion. a single 6-milliliter syringe into each infected quarter; repeat procedure at (a)(1) Specifications. Each 10 milli- 12-hour intervals for a maximum of 3 liters of oil suspension contains the consecutive infusions. equivalent of 400 milligrams of (ii) Dry cows: After milking, clean- novobiocin (present as sodium ing, and disinfecting, infuse contents of novobiocin). a single 12-milliliter syringe into each (2) Sponsor. See No. 054771 in infected quarter at the time of drying § 510.600(c) of this chapter. off. (3) Related tolerances. See § 556.460 of (2) Indications for use. Treatment of this chapter. mastitis due to Staphylococcus aureus, (4) Conditions of use—(i) Amount. Ten Streptococcus agalactiae, Streptococcus milliliters (equivalent to 400 milli- dysgalactiae, and Streptococcus uberis in grams of novobiocin) infused in each lactating or dry cows. quarter. (3) Limitations. Milk taken from ani- (ii) Indications for use. It is used in mals during treatment and for 36 hours dry cows for the treatment of mastitis (3 milkings) after the latest treatment caused by susceptible strains of Staphy- must not be used for food. lococcus aureus and Streptococcus agalactiae. [47 FR 15772, Apr. 13, 1982, as amended at 66 (iii) Limitations. Infuse each quarter FR 14074, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 79 FR 10973, Feb. 27, 2014; 84 FR 8974, at the time of drying off, but not less Mar. 13, 2019; 84 FR 32993, July 11, 2019] than 30 days prior to calving. Do not slaughter treated animals for food use § 526.1130 Hetacillin. for 30 days following udder infusion. (a) Specifications. Each 10 milliliter For udder installation for the treat- syringe contains hetacillin potassium ment of mastitis in dry cows only. equivalent of 62.5 milligrams of ampi- (b)(1) Specifications. Each 10 milli- cillin. liters of oil suspension contains the (b) Sponsor. See No. 000010 in equivalent of 150 milligrams of § 510.600(c) of this chapter. novobiocin (present as sodium (c) Related tolerances. See § 556.316 of novobiocin). this chapter. (2) Sponsor. See No. 054771 in (d) Conditions of use. Lactating cows— § 510.600(c) of this chapter. (1) Amount. 10 milliliters of hetacillin (3) Related tolerances. See § 556.460 of potassium equivalent to 62.5 milli- this chapter. grams ampicillin into each infected (4) Conditions of use—(i) Amount. In- quarter. Repeat at 24-hour intervals fuse 10 milliliters (equivalent to 150 until a maximum of three treatments milligrams of novobiocin) in each quar- has been given. ter after milking. Repeat treatment (2) Indications for use. Treating acute, once after 24 hours. chronic, or subclinical bovine mastitis (ii) Indications for use. Use in lac- in lactating cows caused by susceptible tating cows for treatment of mastitis strains of Streptococcus agalactiae, caused by susceptible strains of Staphy- Streptococcus dysgalactiae, Staphy- lococcus aureus. lococcus aureus, and Escherichia coli. (iii) Limitations. Do not milk for at (3) Limitations. Milk that has been least 6 hours after treatment; after- taken from animals during treatment wards, milk at regular intervals. Milk and for 72 hours (6 milkings) after the taken from treated animals within 72

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hours (6 milkings) after latest treat- § 526.1696b Penicillin G procaine-dihy- ment must not be used for food. Do not drostreptomycin in soybean oil for slaughter treated animals for food for intramammary infusion (dry cows). 15 days following latest treatment. If (a) Specifications. Each 10 milliliters redness, swelling, or abnormal milk of suspension contains penicillin G pro- persists or increases after treatment, caine equivalent to 200,000 units of pen- discontinue use and consult a veteri- icillin G and dihydrostreptomycin sul- narian. For udder instillation in lac- fate equivalent to 300 milligrams of di- tating cattle only. Federal law re- hydrostreptomycin. stricts this drug to use by or on the (b) Sponsor. See No. 042791 in order of a licensed veterinarian. § 510.600(c) of this chapter. [43 FR 10554, Mar. 14, 1978, as amended at 79 (c) Related tolerances. See §§ 556.200 FR 10973, Feb. 27, 2014] and 556.510 of this chapter. (d) Conditions of use. Dairy cows—(1) § 526.1696 Penicillin intramammary Amount. One syringe into each quarter dosage forms. at the last milking prior to drying off. § 526.1696a Penicillin G procaine. (2) Indications for use. Intramammary treatment of subclinical mastitis in (a) Specifications. Each 10-milliliter dairy cows at the time of drying off, single-dose syringe contains penicillin specifically against infections caused G procaine equivalent to 100,000 units by Staphylococcus aureus and Strepto- of penicillin G. coccus agalactiae. (b) Related tolerances. See § 556.510 of this chapter. (3) Limitations. Not to be used within (c) Sponsors. See Nos. 010515 and 6 weeks of calving. For use in dry cows 061133 in § 510.600(c) of this chapter. only. Milk taken from cows within 24 (d) Conditions of use in lactating hours (2 milkings) after calving must cows—(1) Amount. Infuse one 10-milli- not be used for food. Animals infused liter dose into each infected quarter. with this drug must not be slaughtered Treatment may be repeated at 12-hour for food within 60 days of treatment intervals for not more than three nor within 24 hours after calving. doses, as indicated by clinical response. [57 FR 37336, Aug. 18, 1992, as amended at 78 (2) Indications for use. For the treat- FR 21060, Apr. 9, 2013; 83 FR 14587, Apr. 5, ment of mastitis caused by Strepto- 2018] coccus agalactiae, S. dysgalactiae, and S. uberus in lactating cows. § 526.1696c Penicillin G procaine-dihy- (3) Limitations. Milk that has been drostreptomycin sulfate for taken from animals during treatment intramammary infusion (dry cows). and for 60 hours after the latest treat- (a) Specifications. Each 10 milliliters ment must not be used for food. Ani- of suspension contains penicillin G pro- mals must not be slaughtered for food caine equivalent to 1 million units of during treatment or within 3 days after penicillin G and dihydrostreptomycin the latest treatment. sulfate equivalent to 1 gram of dihy- (e) Conditions of use in dry cows—(1) drostreptomycin. Amount. Infuse one 10-milliliter dose (b) Sponsor. See No. 042791 in into each infected quarter at time of § 510.600(c) of this chapter. drying-off. (c) Related tolerances. See §§ 556.200 (2) Indications of use. For the treat- and 556.510 of this chapter. ment of mastitis caused by Strepto- (d) Conditions of use. Dairy cows—(1) coccus agalactiae in dry cows. Amount. One syringe per quarter at the (3) Limitations. Discard all milk for 72 last milking prior to drying off. hours (6 milkings) following calving, or (2) Indications for use. Intramammary later as indicated by the marketable use to reduce the frequency of existing quality of the milk. Animals must not infection and to prevent new infections be slaughtered for food within 14 days with Staphylococcus aureus in dry cows. postinfusion. (3) Limitations. Not to be used within [73 FR 18442, Apr. 4, 2008, as amended at 74 6 weeks of freshening. Not for use in FR 18990, Apr. 27, 2009; 84 FR 8974, Mar. 13, lactating cows. Milk taken from ani- 2019] mals within 96 hours (8 milkings) after

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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 be slaughtered for food within 60 days slaughtered for food for 30 days fol- from the time of infusion nor within 96 lowing udder infusion. hours after calving. Federal law re- [57 FR 37336, Aug. 18, 1992; 57 FR 42623, Sept. stricts this drug to use by or on the 15, 1992; 79 FR 10973, Feb. 27, 2014; 84 FR 32993, order of a licensed veterinarian. July 11, 2019] [57 FR 37336, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 79 FR 10965, Feb. 27, 2014] § 526.1810 Pirlimycin. (a) Specifications. Each 10-milliliter § 526.1696d Penicillin G procaine- syringe contains 50 milligrams (mg) novobiocin for intramammary infu- pirlimycin (as pirlimycin hydro- sion. chloride). (a) Specifications. For lactating cat- (b) Sponsor. See No. 054771 in tle: each 10-milliliter dose contains § 510.600(c) of this chapter. 100,000 units of penicillin G procaine (c) Related tolerances. See § 556.515 of and 150 milligrams of novobiocin as this chapter. novobiocin sodium. For dry cows: (d) Conditions of use in cattle—(1) 200,000 units of penicillin G procaine Amount. Infuse 50 mg into each infected and 400 milligrams of novobiocin as quarter. Repeat treatment after 24 novobiocin sodium. hours. Daily treatment may be re- (b) Sponsor. See No. 054771 in peated at 24-hour intervals for up to 8 § 510.600(c) of this chapter. consecutive days. (c) Related tolerances. See §§ 556.460 (2) Indications for use. For the treat- and 556.510 of this chapter. ment of clinical and subclinical mas- (d) Conditions of use—(1) Lactating titis in lactating dairy cattle associ- cows—(i) Amount. 10 milliliters in each ated with Staphylococcus species such infected quarter after milking. Repeat as Staphylococcus aureus and Strepto- once after 24 hours. coccus species such as Streptococcus (ii) Indications for use. Treating lac- agalactiae, Streptococcus dysgalactiae, tating cows for mastitis caused by sus- and Streptococcus uberis. ceptible strains of Staphylococcus (3) Limitations. Milk taken from ani- aureus, Streptococcus agalactiae, Strepto- mals during treatment and for 36 hours coccus dysgalactiae, and Streptococcus following the last treatment must not uberis. (iii) Limitations. For udder instilla- be used for food regardless of treat- tion in lactating cattle only. Do not ment duration. Following infusion milk for at least 6 hours after treat- twice at a 24-hour interval, treated ani- ment; thereafter, milk at regular inter- mals must not be slaughtered for 9 vals. Milk taken from treated animals days. Following any extended duration within 72 hours (6 milkings) after the of therapy (infusion longer than twice latest treatment must not be used for at a 24-hour interval, up to 8 consecu- food. Treated animals must not be tive days), animals must not be slaugh- slaughtered for food for 15 days fol- tered for 21 days. Federal law restricts lowing the latest treatment. If redness, this drug to use by or on the order of a swelling, or abnormal milk persists, licensed veterinarian. discontinue use and consult a veteri- [58 FR 58486, Nov. 2, 1993, as amended at 65 narian. FR 61091, Oct. 16, 2000; 73 FR 811, Jan. 4, 2008; (2) Dry cows—(i) Amount. 10 milli- 79 FR 10973, Feb. 27, 2014] liters in each quarter at time of drying off. PART 528—NEW ANIMAL DRUGS IN (ii) Indications for use. Treatment of GENETICALLY ENGINEERED ANI- subclinical mastitis caused by suscep- MALS tible strains of Staphylococcus aureus and Streptococcus agalactiae. Sec. (iii) Limitations. For udder instilla- 528.1070 Bc6 recombinant deoxyribonucleic tion in dry cows only. Do not use less acid construct. than 30 days prior to calving. Milk 528.1080 Bc2371 recombinant from treated cows must not be used for deoxyribonucleic acid construct.

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528.1092 opAFP-GHc2 recombinant § 528.1092 opAFP-GHc2 recombinant deoxyribonucleic acid construct. deoxyribonucleic acid construct. 528.2010 Human lysosomal acid lipase recombinant deoxyribonucleic acid con- (a) Specifications. A single copy of the struct. a-form of the opAFP–GHc2 recombinant deoxyribonucleic acid (rDNA) con- AUTHORITY: 21 U.S.C. 360b. struct at the a-locus in the EO–1 a lin- SOURCE: 74 FR 6823, Feb. 11, 2009, unless eage of triploid, hemizygous, all-female otherwise noted. Atlantic salmon (Salmo salar). (b) Sponsor. See No. 086053 in § 510.600 § 528.1070 Bc6 recombinant of this chapter. deoxyribonucleic acid construct. (c) Indications for use. Significantly (a) Specifications and indications for more of these Atlantic salmon grow to use. Five copies of a human Bc6 recom- at least 100 grams within 2,700 Celsius binant deoxyribonucleic acid (rDNA) degree-days than their comparators. construct located at the GTC 155–92 (d) Limitations. These Atlantic salm- site in a specific hemizygous diploid on are produced as eyed-eggs and line of dairy breeds of domestic goats grown-out only in physically-con- (Capra aegagrus hircus) directing the tained, freshwater culture facilities expression of the human gene for specified in an FDA-approved applica- antithrombin (which is intended for tion. the treatment of humans) in the mam- [80 FR 73104, Nov. 24, 2015] mary gland of goats derived from lineage progenitor 155–92. § 528.2010 Human lysosomal acid (b) Sponsor. See No. 086047 in § 510.600 lipase recombinant of this chapter. deoxyribonucleic acid construct. (c) Limitations. Food or feed from (a) Specifications. A single copy of a GTC–155–92 goats is not permitted in human lysosomal acid lipase (hLAL) the food or feed supply. recombinant deoxyribonucleic acid (rDNA) gene construct located at the [74 FR 6823, Feb. 11, 2009, as amended at 80 FR 34279, June 16, 2015] SYN LAL–C site in chromosome 6 in a specific, diploid line (SBC LAL–C) of § 528.1080 Bc2371 recombinant hemizygous and homozygous domestic deoxyribonucleic acid construct. chickens (Gallus gallus), derived from the lineage progenitor XLL 109. (a) A Specifications and intended use. (b) Sponsor. See No. 069334 in § 510.600 single copy of Bc2371, a human Factor of this chapter. VII recombinant deoxyribonucleic acid (c) Conditions of use—(1) Intended use. (rDNA) gene construct, located on The gene construct directs the expres- chromosome 3p1.1–2 in a diploid line sion of that encoding gene such that (R69) of hemizygous and homozygous recombinant, human lysosomal acid New Zealand white rabbits (Oryctolagus lipase (rhLAL) protein intended for the cuniculus). treatment of human disease is present (b) Sponsor. See No. 086047 in § 510.600 in SBC LAL–C chicken egg whites. of this chapter. (2) Limitations. Food or feed from (c) Conditions of use—(1) Intended use. XLL 109 chickens is not permitted in The construct directs gene expression the food or feed supply. of recombinant human Factor VII (hFVII) in the mammary gland such [81 FR 17608, Mar. 30, 2016] that recombinant hFVII zymogen is present in the rabbit milk, enabling pu- PART 529—CERTAIN OTHER DOS- rification and activation of recom- AGE FORM NEW ANIMAL binant hFVIIa intended for the treat- DRUGS ment of hemophilia A or B in humans with inhibitors to Factors VIII and IX. Sec. (2) Limitations. Food or feed from R69 529.40 Albuterol. rabbits is not permitted in the food or 529.56 Amikacin. feed supply. 529.382 Chloramine-T. 529.400 Chlorhexidine tablets and suspen- [84 FR 12494, Apr. 2, 2019] sion.

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529.536 Detomidine. logical saline by intrauterine infusion 529.539 Dexmedetomidine. daily for 3 consecutive days. 529.778 Doxycycline. (2) Indications for use. For treating 529.1030 Formalin. genital tract infections (endometritis, 529.1044 Gentamicin in certain other dosage forms. metritis, and pyometra) in mares 529.1044a Gentamicin solution for infusion. caused by susceptible organisms in- 529.1044b Gentamicin solution for dipping cluding Escherichia coli, Pseudomonas eggs. spp., and Klebsiella spp. 529.1115 Halothane. (3) Limitations. Do not use in horses 529.1150 Hydrogen peroxide. intended for human consumption. Fed- 529.1186 Isoflurane. 529.1350 Meloxicam. eral law restricts this drug to use by or 529.1660 Oxytetracycline. on the order of a licensed veterinarian. 529.1940 Progesterone intravaginal inserts. [76 FR 17339, Mar. 29, 2011, as amended at 78 529.2150 Sevoflurane. FR 17597, Mar. 22, 2013; 79 FR 10973, Feb. 27, 529.2464 Ticarcillin. 2014] 529.2503 Tricaine methanesulfonate. 529.2620 Triptorelin. § 529.382 Chloramine-T. AUTHORITY: 21 U.S.C. 360b. (a) Specifications. Chloramine-T tri- SOURCE: 40 FR 13881, Mar. 27, 1975, unless hydrate powder for solution. otherwise noted. (b) Sponsor. See No. 086009 in § 510.600(c) of this chapter. § 529.40 Albuterol. (c) Related tolerances. See § 556.118 of (a) Specifications. A net weight of 6.7 this chapter. grams of formulated albuterol sulfate (d) Conditions of use—(1) Freshwater- is supplied in a pressurized aluminum reared salmonids—(i) Amount. 12 to 20 canister within an actuator system milligrams per liter (mg/L) water in a equipped with a detachable nasal deliv- continuous flow water supply or as a ery bulb. static bath once per day for 60 minutes (b) Approvals. See No. 000010 in § 510.600(c) of this chapter for uses as in on consecutive or alternative days for paragraph (d) of this section. three treatments. (c) Conditions of use—(1) Amount. (ii) Indications for use. For the control Each valve actuation (puff) of the de- of mortality in freshwater-reared vice delivers 120 micrograms (mcg) of salmonids due to bacterial gill disease albuterol sulfate. One dose is three (3) associated with Flavobacterium spp. puffs, totaling 360 mcg. (2) Walleye—(i) Amount. 10 to 20 mg/L (2) Indications for use. For the imme- water in a continuous flow water sup- diate relief of bronchospasm and ply or as a static bath once per day for bronchoconstriction associated with 60 minutes on consecutive or alter- reversible airway obstruction in native days for three treatments. horses. (ii) Indications for use. For the control (3) Not for use in horses intended for of mortality in walleye due to external food. Federal law restricts this drug to columnaris disease associated with use by or on the order of a licensed vet- Flavobacterium columnare. erinarian. (3) Freshwater-reared warmwater [67 FR 7072, Feb. 15, 2002, as amended at 79 finfish—(i) Amount. 20 mg/L water in a FR 10973, Feb. 27 , 2014] continuous flow water supply or as a static bath once per day for 60 minutes § 529.56 Amikacin. on consecutive or alternative days for (a) Specifications. Each milliliter three treatments. (mL) of solution contains 250 milli- (ii) Indications for use. For the control grams of amikacin as amikacin sulfate. of mortality in freshwater-reared (b) Sponsors. See Nos. 000859 and warmwater finfish due to external 054771 in § 510.600(c) of this chapter. columnaris disease associated with F. (c) Conditions of use in horses—(1) columnare. Amount. Administer 2 grams (8 mL) diluted with 200 mL of sterile physio- [79 FR 37621, July 2, 2014]

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§ 529.400 Chlorhexidine tablets and § 529.539 Dexmedetomidine. suspension. (a) Specifications. Each milliliter of (a) Specification. Each tablet and each gel contains 0.09 milligrams (mg) 28-milliliter syringe of suspension con- dexmedetomidine (equivalent to 0.1 mg tain 1 gram of chlorhexidine dexmedetomidine hydrochloride). dihydrochloride. (b) Sponsor. See No. 052483 in (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Ad- (c) Related tolerances. See § 556.120 of minister onto the oral mucosa between this chapter. the dog’s cheek and gum at a dose of (d) Conditions of use—(1) Amount. 125 micrograms per square meter. Place 1 or 2 tablets deep in each uter- (2) Indications for use. For the treat- ine horn; or infuse a solution of 1 tablet disolved in an appropriate amount ment of noise aversion in dogs. of clean boiled water; or infuse one sy- (3) Limitations. Federal law restricts ringe of suspension into the uterus. this drug to use by or on the order of a (2) Indications for use. For prevention licensed veterinarian. or treatment of metritis and vaginitis [81 FR 17608, Mar. 30, 2016] in cows and mares when caused by pathogens sensitive to chlorhexidine § 529.778 Doxycycline. dihydrochloride. (a) Specifications. Doxycycline (3) Limitations. Prior to administra- hyclate solution contains 8.5 percent tion, remove any unattached placental doxycycline activity. A syringe of N- membranes, any excess uterine fluid or methyl-2-pyrrolidone and poly (DL- debris, and carefully clean external genitalia. Use a clean, sterile insemi- lactide) mixed with a syringe of nating pipette for administrating solu- doxycycline produces 0.5 milliliter of tions and suspensions. Treatment may solution. be repeated in 48 to 72 hours. (b) Sponsor. See 054771 in § 510.600(c) of this chapter. [43 FR 10705, Feb. 23, 1979, as amended at 79 (c) Conditions of use in dogs—(1) FR 10973, Feb. 27, 2014; 81 FR 67152, Sept. 30, 2016; 84 FR 32993, July 11, 2019] Amount. Apply subgingivally to periodontal pocket(s) of affected teeth. EDITORIAL NOTE: At 79 FR 10973, Feb. 27, (2) Indications for use. For treatment 2014, § 529.400 was amended by revising the section heading, however, the section head- and control of periodontal disease. ing was not provided, therefore, the amend- (3) Limitations. Federal law restricts ment could not be incorporated because of an this drug to use by or on the order of a inaccurate amendatory instruction. licensed veterinarian. § 529.536 Detomidine. [79 FR 10973, Feb. 27, 2014] (a) Specifications. Each milliliter of § 529.1030 Formalin. gel contains 7.6 milligrams (mg) of detomidine hydrochloride. (a) Specifications. Formalin is an (b) Sponsor. See No. 052483 in aqueous solution containing approxi- § 510.600(c) of this chapter. mately 37 percent by weight of form- (c) Conditions of use in horses—(1) aldehyde gas, U.S.P. Amount. Administer 0.018 mg per pound (b) Sponsors. See sponsors in (mg/lb) (0.040 mg/kilogram (kg) sublin- § 510.600(c) of this chapter for uses as in gually. paragraph (d) of this section. (2) Indications for use. For sedation (1) No. 050378 for use as in paragraph and restraint. (d) of this section. (3) Limitations. Federal law restricts (2) Nos. 049968 and 067188 for use as in this drug to use by or on the order of a paragraphs (d)(1)(i), (ii), and (iii), licensed veterinarian. Do not use in (d)(2)(i), (ii), and (iii), and (d)(3) of this horses intended for human consump- section. tion. (c) [Reserved] [75 FR 21163, Apr. 23, 2010, as amended at 76 (d) Conditions of use. It is added to en- FR 16533, Mar. 24, 2011] vironmental water as follows:

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(1) Indications for use. (i) Penaeid (ppm) for 15 minutes. A preliminary shrimp. For control of external proto- bioassay should be conducted on a zoan parasites Bodo spp., Epistylis spp., small subsample of fish eggs to deter- and Zoothamnium spp. mine sensitivity before treating an en- (ii) All finfish. For control of exter- tire group. This is necessary for all spe- nal protozoa Ichthyophthirius spp., cies because egg sensitivity can vary Chilodonella spp., Ichthyobodo spp., with species or strain and the unique Ambiphrya spp., Epistylis spp., and conditions at each facility. Trichodina spp., and the monogeneans (iv) For the control of mortality in Cleidodiscus spp., Gyrodactylus spp., and freshwater-reared finfish due to Dactylogyrus spp. saprolegniasis associated with fungi in (iii) All finfish eggs: For control of the family Saprolegniaceae: In tanks fungi of the family Saprolegniaceae. and raceways, administer 150 μL/L (iv) Freshwater-reared finfish. For the (ppm) for 60 minutes per day on alter- control of mortality due to nate days for three treatments. saprolegniasis associated with fungi in (3) Limitations. Fish tanks and race- the family Saprolegniaceae. ways may be treated daily until para- (2) Amount. The drug concentrations site control is achieved. Pond treat- required are as follows: ment may be repeated in 5 to 10 days if (i) For control of external protozoan needed. However, pond treatments for parasites on shrimp: Ichthyophthirius spp. should be made at 2-day intervals until control is Concentration of formalin (microliters per liter) achieved. Egg tanks may be treated as often as necessary to prevent growth of Shrimp Tanks and raceways (up to 4 Earthen ponds fungi. Do not use formalin which has hours daily) (single treatment) been subjected to temperatures below ° Penaeid Shrimp ... 50 to 100 1 ...... 25 2 40 F, or allowed to freeze. Treatments in tanks and raceways should never ex- 1 Treat for up to 4 hours daily. Treatment may be repeated daily until parasite control is achieved. Use the lower con- ceed 1 hour for fish or 4 hours for centration when tanks or raceways are heavily loaded with penaeid shrimp (even if they show no phytoplankton or shrimp, to avoid oxygen depletion due to the biological oxygen demand created by decay of dead sign of distress), nor should it exceed 15 phytoplankton. Alternatively, a higher concentration might be minutes for fish eggs. Do not apply for- used if dissolved oxygen is strictly monitored. 2 Single treatment. Treatment may be repeated in 5 to 10 malin to ponds with water warmer days if needed. than 27 °C (80 °F), when a heavy bloom (ii) For control of external parasites of phytoplankton is present, or when on finfish: the concentration of dissolved oxygen is less than 5 milligrams per liter. Administer in tanks and raceways for Administer in [51 FR 11441, Apr. 3, 1986, as amended at 58 up to 1 hour earthen ponds sin- FR 59169, Nov. 8, 1993; 59 FR 60076, Nov. 22, Aquatic species (microliter/liter or gle treatment (μL/L part per million or ppm) 1994; 63 FR 38304, July 16, 1998; 68 FR 5563; (μL/L or ppm)) Feb. 4, 2003; 72 FR 45158, Aug. 13, 2007; 76 FR 17339, Mar. 29, 2011; 79 FR 2786, Jan. 16, 2014; Salmon and trout: 82 FR 58556, Dec. 13, 2017; 84 FR 53311, Oct. 7, Above 50 °F Up to 170 15 to 25 12 2019] Below 50 °F Up to 250 15 to 25 12 All other finfish Up to 250 15 to 25 12 § 529.1044 Gentamicin in certain other 1 Use the lower concentration when ponds, tanks, or race- dosage forms. ways are heavily loaded with phytoplankton or fish to avoid oxygen depletion due to the biological oxygen demand by decay of dead phytoplankton. Alternatively, a higher con- § 529.1044a Gentamicin solution for in- centration may be used if dissolved oxygen is strictly monitored. fusion. 2 Although the indicated concentrations are considered safe for cold and warm water finfish, a small number of each lot or (a) Specifications. Each milliliter of pond to be treated should always be used to check for any solution contains 50 or 100 milligrams unusual sensitivity to formalin before proceeding. gentamicin sulfate. (iii) For control of fungi of the fam- (b) Sponsors. See Nos. 000061, 000859, ily Saprolegniaceae on finfish eggs: 016592, 054628, 054771, 058005, and 061133 Eggs of all finfish except in § 510.600(c) of this chapter. Acipenseriformes, 1,000 to 2,000 μL/L (c) Conditions of use in horses—(1) (ppm) for 15 minutes; eggs of Amount. Infuse 2 to 2.5 grams per day Acipenseriformes, up to 1,500 μL/L for 3 to 5 days during estrus.

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(2) Indications for use. For control of § 529.1115 Halothane. bacterial infections of the uterus (me- (a) Specifications. The drug is a color- tritis) and as an aid in improving con- less, odorless, nonflammable, nonexplo- ception in mares with uterine infec- sive, heavy liquid containing 0.01 per- tions caused by bacteria sensitive to cent thymol as a preservative. gentamicin. (b) Sponsor. See No. 054771 in (3) Limitations. Do not use in horses § 510.600(c) of this chapter. intended for human consumption. Fed- (c) Conditions of use—(1) Amount. Two eral law restricts this drug to use by or to 5 percent of inhaled atmosphere for on the order of a licensed veterinarian. induction of anesthesia; 0.5 to 2 percent for maintenance of anesthesia. [71 FR 51727, Aug. 31, 2006, as amended at 78 FR 17597, Mar. 22, 2013; 78 FR 21060, Apr. 9, (2) Indications for use. For nonfood 2013; 79 FR 10973, Feb. 27, 2014; 83 FR 48947, animals for the induction and mainte- Sept. 28, 2018; 84 FR 8974, Mar. 13, 2019] nance of anesthesia. (3) Limitations. Not for use in animals § 529.1044b Gentamicin solution for intended for food. Federal law restricts dipping eggs. this drug to use by or on the order of a licensed veterinarian. (a) Specifications. Each milliliter of solution contains gentamicin sulfate [46 FR 27915, May 22, 1981, as amended at 62 equivalent to 50 milligrams of FR 29014, May 29, 1997; 79 FR 10973, Feb. 27, gentamicin base. 2014; 85 FR 4208, Jan. 24, 2020] (b) Sponsors. See Nos. 000061 and § 529.1150 Hydrogen peroxide. 054925 in § 510.600(c) of this chapter. (c) Conditions of use in turkeys—(1) (a) Specifications. Each milliliter of solution contains 396.1 milligrams (mg) Amount. The drug is added to clean hydrogen peroxide (a 35% w/w solu- water to provide a dip solution with a tion). gentamicin concentration of 250 to (b) Sponsor. See No. 050378 in 1,000 parts per million. A concentration § 510.600(c) of this chapter. of 500 parts per million is rec- (c) Conditions of use—(1) Indications ommended. Clean eggs should be held and amount. (i) Freshwater-reared submerged in the gentamicin solution finfish eggs for the control of mortality under a vacuum of about 27.5 to 38 cen- in due to saprolegniasis associated timeters of mercury for 5 minutes fol- with fungi in the family lowed by additional soaking in Saprolegniaceae: gentamicin solution for approximately (A) For all coldwater and coolwater 10 minutes at atmospheric pressure. species of freshwater-reared finfish Eggs can also be treated by warming eggs: 500 to 1,000 mg per liter (/L) of them for 3 to 6 hours at approximately culture water for 15 minutes in a con- 100 °F then immediately submerging tinuous flow system once per day on them in gentamicin solution main- consecutive or alternate days until tained at about 40 °F, keeping the eggs hatch, or submerged for 10 to 15 minutes. (B) For all freshwater-reared (2) Indications for use. As an aid in the warmwater finfish eggs: 750 to 1,000 mg/ reduction or elimination of the fol- L for 15 minutes in a continuous flow lowing microorganisms from turkey- system once per day on consecutive or hatching eggs: Arizona hinshawii alternate days until hatch. (paracolon), Salmonella Saintpaul, and (ii) Freshwater-reared finfish for the control of mortality due to Mycoplasma meleagridis. saprolegniasis associated with the (3) For use in the dipping Limitations. fungi in the family Saprolegniaceae: treatment of turkey-hatching eggs For freshwater-reared coldwater finfish only. Eggs which have been dipped in including salmonids (all life stages), the drug shall not be used for food. freshwater-reared coolwater finfish [40 FR 13881, Mar. 27, 1975, as amended at 52 fingerlings and adults, and freshwater- FR 7833, Mar. 13, 1987; 62 FR 22889, Apr. 28, reared warmwater finfish fingerlings 1997; 71 FR 13543, Mar. 16, 2006; 79 FR 10973, and adults: 75 mg/L for 60 minutes in Feb. 27, 2014] continuous flow water supply or as a

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static bath once per day on alternate Use with caution on walleye (Sander days for three treatments. vitreus) and ornamental finfish. (iii) Freshwater-reared salmonids for (iv) Preharvest withdrawal time: the control of mortality due to bac- Zero days. terial gill disease associated with Flavobacterium branchiophilum: 100 mg/L [72 FR 5330, Feb. 6, 2007, as amended at 78 FR 73698, Dec. 9, 2013; 85 FR 4208, Jan. 24, 2020] for 30 minutes, or 50 to 100 mg/L for 60 minutes, in a continuous flow water § 529.1186 Isoflurane. supply or as a static bath once per day on alternate days for three treatments. (a) Specifications. The drug is a clear, (iv) Freshwater-reared salmonids for colorless, stable liquid. the treatment and control of (b) Sponsors. See Nos. 012164, 054771, Gyrodactylus spp: 100 mg/L for 30 min- 065085, and 066794 in § 510.600(c) of this utes, or 50 to 100 mg/L for 60 minutes, chapter. in a continuous flow water supply or as (c) Conditions of use. Administer by a static bath once per day on alternate inhalation: days for three treatments. (1) Amount—(i) Horses: For induction (v) Freshwater-reared coolwater and of surgical anesthesia: 3 to 5 percent warmwater finfish fingerlings and isoflurane (with oxygen) for 5 to 10 adults for the control of mortality due minutes. For maintenance of surgical to external columnaris disease associ- anesthesia: 1.5 to 1.8 percent isoflurane ated with Flavobacterium columnare: 50 (with oxygen). to 75 mg/L for 60 minutes in continuous (ii) Dogs: For induction of surgical flow water supply or as a static bath anesthesia: 2 to 2.5 percent isoflurane once per day on alternate days for (with oxygen) for 5 to 10 minutes. For three treatments. maintenance of surgical anesthesia: 1.5 (vi) Freshwater-reared coolwater to 1.8 percent isoflurane (with oxygen). finfish fry and warmwater finfish fry (2) Indications for use. For induction for the control of mortality due to ex- and maintenance of general anesthesia ternal columnaris disease associated in horses and dogs. with Flavobacterium columnare: 50 mg/L (3) Limitations. Do not use in horses for 60 minutes in continuous flow water intended for human consumption. Fed- supply or as a static bath once per day eral law restricts this drug to use by or on alternate days for three treatments. on the order of a licensed veterinarian. (2) Limitations. (i) Initial bioassay on a small number is recommended before [51 FR 594, Jan. 7, 1986, as amended at 54 FR treating the entire group. 23472, June 1, 1989; 58 FR 17346, Apr. 2, 1993; 59 (ii) Eggs: Some strains of rainbow FR 44315, Aug. 29, 1994; 60 FR 40456, Aug. 9, trout eggs are sensitive to hydrogen 1995; 63 FR 8122, Feb. 18, 1998; 63 FR 24106, peroxide treatment at a time during in- May 1, 1998; 66 FR 17510, Apr. 2, 2001; 71 FR 43967, Aug. 3, 2006; 74 FR 68530, Dec. 28, 2009; cubation concurrent with blastopore 76 FR 16533, Mar. 24, 2011; 78 FR 14669, Mar. 7, formation through closure, about 70 to 2013; 78 FR 17868, Mar. 25, 2013; 80 FR 18776, 140 Daily Temperature Units, °C. Con- Apr. 8, 2015; 82 FR 12170, Mar. 1, 2017] sider withholding treatment or using an alternate therapeutant during that § 529.1350 Meloxicam. sensitive time to reduce egg mortali- (a) Each milliliter of ties due to drug toxicity. Specifications. solution contains 5 milligrams (mg) (iii) Finfish: Because finfish sensi- meloxicam. tivity to 35% PEROX–AID® increases with increasing water temperature, (b) Sponsor. See No. 054771 in consider administering initial treat- § 510.600(c) of this chapter. ments at the lower end of the treat- (c) Conditions of use in dogs—(1) ment regimen or reducing water tem- Amount. Administer 0.1 mg per kilo- perature before treatment. Do not use gram of body weight once daily using this product to treat northern pike the metered dose pump. (Esox lucius) or paddlefish (Polyodon (2) Indications for use. For the control spathula) of any age. Do not use this of pain and inflammation associated product to treat pallid sturgeon fry. with osteoarthritis in dogs.

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(3) Limitations. Federal law restricts (d) Special considerations. Product la- this drug to use by or on the order of a beling shall bear the following warn- licensed veterinarian. ing: ‘‘Avoid contact with skin by wear- [77 FR 76863, Dec. 31, 2012, as amended at 80 ing protective gloves when handling in- FR 18776, Apr. 8, 2015] serts. Store removed inserts in a seal- able container until they can be dis- § 529.1660 Oxytetracycline. posed of in accordance with applicable (a) Specifications. (1) Each gram of local, state, and Federal regulations.’’ powder contains 366 milligrams (mg) (e) Conditions of use—(1) Cows—(i) oxytetracycline hydrochloride. Amount. Administer one intravaginal (2) Each gram of powder contains 753 insert per animal for 7 days. When used mg oxytetracycline hydrochloride. for indications listed in paragraph (b) Sponsors. See sponsors in (e)(1)(ii)(A) of this section, administer § 510.600(c) of this chapter for use of 25 mg dinoprost as a single products described in paragraph (a) of intramuscular injection 1 day prior to this section as in paragraph (d) of this insert removal (Day 6). When used for section. indications listed in paragraph (1) Nos. 054771 and 061133 for use of (e)(1)(ii)(B) of this section, administer product in paragraph (a)(1) of this sec- 25 mg dinoprost as a single tion. intramuscular injection on the day of (2) Nos. 054771, 061133, and 069254 for insert removal (Day 7). use of product described in paragraph (ii) Indications for use. (A) For syn- (a)(2) of this section. chronization of estrus in suckled beef (c) Related tolerances. See § 556.500 of cows and replacement beef and dairy this chapter. heifers; for advancement of first (d) Conditions of use in finfish—(1) postpartum estrus in suckled beef Amount. Immerse fish in a solution cows; and for advancement of first pu- containing 200 to 700 mg oxytetra- bertal estrus in replacement beef heif- cycline hydrochloride (buffered) per ers. liter of water for 2 to 6 hours. (B) For synchronization of estrus in (2) Indications for use. For skeletal lactating dairy cows. marking of finfish fry and fingerlings. (C) For synchronization of the return (3) Limitations. Federal law restricts to estrus in lactating dairy cows in- this drug to use by or on the order of a seminated at the immediately pre- licensed veterinarian. ceding estrus. [69 FR 6557, Feb. 11, 2004, as amended at 69 (D) For induction of estrous cycles in FR 61999, Oct. 22, 2004; 70 FR 41140, July 18, anestrous lactating dairy cows. 2005; 72 FR 26289, May 9, 2007; 76 FR 17026, (iii) Limitations. Do not use in beef or Mar. 28, 2011; 79 FR 10973, Feb. 27, 2014; 81 FR 22524, Apr. 18, 2016; 81 FR 94991, Dec. 27, 2016; dairy heifers of insufficient size or age 84 FR 8974, Mar. 13, 2019] for breeding or in animals with abnormal, immature, or infected genital § 529.1940 Progesterone intravaginal tracts. Do not use in beef cows that are inserts. fewer than 20 days postpartum. Do not (a) Specifications. Each insert con- use an insert more than once. To pre- tains: vent the potential transmission of ve- (1) 1.38 grams (g) progesterone in nereal and bloodborne diseases, the in- molded silicone over a nylon spine. serts should be disposed after a single (2) 0.3 g progesterone in molded sili- use. Administration of vaginal inserts cone over a flexible nylon spine. for periods greater than 7 days may re- (b) Sponsor. See No. 054771 in sult in reduced fertility. Dinoprost in- § 510.600(c) of this chapter for use of the jection for use in paragraphs product described in paragraph (a)(1) of (e)(1)(ii)(A) and (e)(1)(ii)(B) of this sec- this section as in paragraph (e)(1) of tion as in § 522.690 of this chapter, pro- this section; and the product described vided by No. 054771 in § 510.600(c) of this in paragraph (a)(2) of this section as in chapter. paragraph (e)(2) of this section. (2) Ewes—(i) Amount. Administer one (c) Related tolerances. See § 556.540 of intravaginal insert per animal for 5 this chapter. days.

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(ii) Indications for use. For induction eral law restricts this drug to use by or of estrus in ewes (sheep) during sea- on the order of a licensed veterinarian. sonal anestrus. [79 FR 10974, Feb. 27, 2014] (iii) Limitations. Do not use in animals with abnormal, immature, or in- § 529.2503 Tricaine methanesulfonate. fected genital tracts; or in ewes that (a) Specifications. The drug is ethyl-m- have never lambed. Do not use an in- amino-benzoate methanesulfonate. sert more than once. To prevent the (b) Sponsor. See Nos. 050378 and 051212 potential transmission of venereal and in § 510.600(c) of this chapter. bloodborne diseases, the inserts should (c) Conditions of use—(1) Amount. It is be disposed after a single use. used as follows: (i) Fish. The drug is added to ambient [74 FR 59074, Nov. 17, 2009, as amended at 75 FR 63085, Oct. 14, 2010; 79 FR 10965, 10974, Feb. water at a concentration of from 15 to 27, 2014; 79 FR 44278, July 31, 2014] 330 milligrams per liter depending upon the degree of anesthetization or seda- § 529.2150 Sevoflurane. tion desired, the species and size of the fish, and the temperature and softness (a) Specifications. Sevoflurane liquid. of the water. Preliminary tests of solu- (b) Sponsors. See Nos. 012164, 054771, tions must be made with small num- and 066794 in § 510.600(c) of this chapter. bers of fish to determine the desired (c) Conditions of use—(1) Amount. For rates of sedation or anesthesia and the induction of surgical anesthesia: up to appropriate exposure times for the spe- 7 percent sevoflurane. For maintenance cific lots of fish under prevailing condi- of surgical anesthesia: 3.7 to 4 percent tions. sevoflurane with oxygen in the absence (ii) Amphibians and other aquatic cold- of premedication and 3.3 to 3.6 percent blooded animals. The drug is added to in the presence of premedication. ambient water in concentrations of (2) Indications for use. For induction from 1:1000 to 1:20,000 depending upon and maintenance of general anesthesia species and stage of development. in dogs. (2) Indications for use. For the tem- (3) Limitations. Federal law restricts porary immobilization of fish, amphib- this drug to use by or on the order of a ians, and other aquatic coldblooded licensed veterinarian. animals (poikilotherms) as an aid in handling during manual spawning (fish [64 FR 71640, Dec. 22, 1999, as amended at 73 stripping), weighing, measuring, mark- FR 25508, May 7, 2008; 74 FR 10484, Mar. 11, ing, surgical operations, transport, 2009, 75 FR 1021, Jan. 8, 2010; 76 FR 16533, Mar. photography, and research. 24, 2011; 78 FR 17868, Mar. 25, 2013; 80 FR 18776, (3) Limitations. Do not use within 21 Apr. 8, 2015] days of harvesting fish for food. Use in fish intended for food should be re- § 529.2464 Ticarcillin. stricted to Ictaluridae, Salmonidae, (a) Specifications. Each vial contains Esocidae, and Percidae, and water tem- 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.

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(2) Indications for use. For the syn- 530.25 Orders prohibiting extralabel uses for chronization of time of insemination in drugs in food-producing animals. weaned sows to facilitate a single Subpart D—Extralabel Use of Human and fixed-time artificial insemination. Animal Drugs in Animals Not Intended (3) Limitations. Not approved for use for Human Consumption in gilts. Safety and effectiveness have not been evaluated in these animals. 530.30 Extralabel drug use in nonfood ani- Should not be used in sows with obvi- mals. ous reproductive tract abnormalities. Subpart E—Safe Levels for Extralabel Use of [77 FR 64717, Oct. 23, 2012] Drugs in Animals and Drugs Prohibited From Extralabel Use in Animals PART 530—EXTRALABEL DRUG USE 530.40 Safe levels and availability of analyt- IN ANIMALS ical methods. 530.41 Drugs prohibited for extralabel use in Subpart A—General Provisions animals. AUTHORITY: 15 U.S.C. 1453, 1454, 1455; 21 Sec. U.S.C. 321, 331, 351, 352, 353, 355, 357, 360b, 371, 530.1 Scope. 379e. 530.2 Purpose. SOURCE: 61 FR 57743, Nov. 7, 1996, unless 530.3 Definitions. otherwise noted. 530.4 Advertising and promotion. 530.5 Veterinary records. Subpart A—General Provisions Subpart B—Rules and Provisions for Extralabel Uses of Drugs in Animals § 530.1 Scope. This part applies to the extralabel 530.10 Provision permitting extralabel use use in an animal of any approved new of animal drugs. animal drug or approved new human 530.11 Limitations. drug by or on the lawful order of a li- 530.12 Labeling. censed veterinarian within the context 530.13 Extralabel use from compounding of of a valid veterinary-client-patient re- approved new animal and approved lationship. human drugs. § 530.2 Purpose. Subpart C—Specific Provisions Relating to Extralabel Use of Animal and Human The purpose of this part is to estab- Drugs in Food-Producing Animals lish conditions for extralabel use or intended extralabel use in animals by or 530.20 Conditions for permitted extralabel on the lawful order of licensed veteri- animal and human drug use in food-pro- narians of Food and Drug Administra- ducing animals. tion approved new animal drugs and 530.21 Prohibitions for food-producing ani- approved new human drugs. Such use is mals. limited to treatment modalities when 530.22 Safe levels and analytical methods the health of an animal is threatened for food-producing animals. or suffering or death may result from 530.23 Procedure for setting and announcing failure to treat. This section imple- safe levels. ments the Animal Medicinal Drug Use 530.24 Procedure for announcing analytical methods for drug residue quantification. Clarification Act of 1994 (the AMDUCA) (Pub. L. 103–396).

§ 530.3 Definitions. (a) Extralabel use means actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease or other conditions) not listed in the labeling, use at

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dosage levels, frequencies, or routes of (3) The practicing veterinarian is administration other than those stated readily available for followup in case of in the labeling, and deviation from the adverse reactions or failure of the regi- labeled withdrawal time based on these men of therapy. Such a relationship different uses. can exist only when the veterinarian (b) FDA means the U.S. Food and has recently seen and is personally ac- Drug Administration. quainted with the keeping and care of (c) The phrase a reasonable probability the animal(s) by virtue of examination that a drug’s use may present a risk to the of the animal(s), and/or by medically public health means that FDA has rea- appropriate and timely visits to the son to believe that use of a drug may premises where the animal(s) are kept. be likely to cause a potential adverse event. § 530.4 Advertising and promotion. (d) The phrase use of a drug may present a risk to the public health means Nothing in this part shall be con- that FDA has information that indi- strued as permitting the advertising or cates that use of a drug may cause an promotion of extralabel uses in ani- adverse event. mals of approved new animal drugs or (e) The phrase use of a drug presents a approved human drugs. risk to the public health means that FDA has evidence that demonstrates that § 530.5 Veterinary records. the use of a drug has caused or likely (a) As a condition of extralabel use will cause an adverse event. permitted under this part, to permit (f) A residue means any compound FDA to ascertain any extralabel use or present in edible tissues that results intended extralabel use of drugs that from the use of a drug, and includes the the agency has determined may drug, its metabolites, and any other present a risk to the public health, vet- substance formed in or on food because erinarians shall maintain the following of the drug’s use. records of extralabel uses. Such records (g) A safe level is a conservative esti- shall be legible, documented in an ac- mate of a drug residue level in edible animal tissue derived from food safety curate and timely manner, and be read- data or other scientific information. ily accessible to permit prompt re- Concentrations of residues in tissue trieval of information. Such records below the safe level will not raise shall be adequate to substantiate the human food safety concerns. A safe identification of the animals and shall level is not a safe concentration or a be maintained either as individual tolerance and does not indicate that an records or, in food animal practices, on approval exists for the drug in that a group, herd, flock, or per-client basis. species or category of animal from Records shall be adequate to provide which the food is derived. the following information: (h) Veterinarian means a person li- (1) The established name of the drug censed by a State or Territory to prac- and its active ingredient, or if formu- tice veterinary medicine. lated from more than one ingredient, (i) A valid veterinarian-client-patient the established name of each ingre- relationship is one in which: dient; (1) A veterinarian has assumed the (2) The condition treated; responsibility for making medical (3) The species of the treated ani- judgments regarding the health of (an) mal(s); animal(s) and the need for medical treatment, and the client (the owner of (4) The dosage administered; the animal or animals or other care- (5) The duration of treatment; taker) has agreed to follow the instruc- (6) The numbers of animals treated; tions of the veterinarian; and (2) There is sufficient knowledge of (7) The specified withdrawal, with- the animal(s) by the veterinarian to holding, or discard time(s), if applica- initiate at least a general or prelimi- ble, for meat, milk, eggs, or any food nary diagnosis of the medical condition which might be derived from any food of the animal(s); and animals treated.

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(b) A veterinarian shall keep all re- narian shall bear or be accompanied by quired records for 2 years or as other- labeling information adequate to as- wise required by Federal or State law, sure the safe and proper use of the whichever is greater. product. Such information shall in- (c) Any person who is in charge, conclude the following: trol, or custody of such records shall, (a) The name and address of the pre- upon request of a person designated by scribing veterinarian. If the drug is dis- FDA, permit such person designated by pensed by a pharmacy on the order of a FDA to, at all reasonable times, have veterinarian, the labeling shall include access to, permit copying, and verify the name of the prescribing veteri- such records. narian and the name and address of the dispensing pharmacy, and may include Subpart B—Rules and Provisions the address of the prescribing veteri- for Extralabel Uses of Drugs in narian; Animals (b) The established name of the drug or, if formulated from more than one § 530.10 Provision permitting active ingredient, the established name extralabel use of animal drugs. of each ingredient; An approved new animal drug or (c) Any directions for use specified by human drug intended to be used for an the veterinarian, including the class/ extralabel purpose in an animal is not species or identification of the animal unsafe under section 512 of the act and or herd, flock, pen, lot, or other group is exempt from the labeling require- of animals being treated, in which the ments of section 502(f) of the act if such drug is intended to be used; the dosage, use is: frequency, and route of administration; (a) By or on the lawful written or and the duration of therapy; oral order of a licensed veterinarian (d) Any cautionary statements; and within the context of a valid veterinarian-client-patient relationship; and (e) The veterinarian’s specified with- (b) In compliance with this part. drawal, withholding, or discard time for meat, milk, eggs, or any other food § 530.11 Limitations. which might be derived from the treated animal or animals. In addition to uses which do not comply with the provision set forth in § 530.13 Extralabel use from § 530.10, the following specific compounding of approved new ani- extralabel uses are not permitted and mal and approved human drugs. result in the drug being deemed unsafe within the meaning of section 512 of (a) This part applies to compounding the act: of a product from approved animal or (a) Extralabel use in an animal of an human drugs by a veterinarian or a approved new animal drug or human pharmacist on the order of a veteri- drug by a lay person (except when narian within the practice of veteri- under the supervision of a licensed vet- nary medicine. Nothing in this part erinarian); shall be construed as permitting (b) Extralabel use of an approved new compounding from bulk drugs. animal drug or human drug in or on an (b) Extralabel use from compounding animal feed; of approved new animal or human (c) Extralabel use resulting in any drugs is permitted if: residue which may present a risk to (1) All relevant portions of this part the public health; and have been complied with; (d) Extralabel use resulting in any (2) There is no approved new animal residue above an established safe level, or approved new human drug that, safe concentration or tolerance. when used as labeled or in conformity with criteria established in this part, § 530.12 Labeling. will, in the available dosage form and Any human or animal drug pre- concentration, appropriately treat the scribed and dispensed for extralabel use condition diagnosed. Compounding by a veterinarian or dispensed by a from a human drug for use in food-pro- pharmacist on the order of a veteri- ducing animals will not be permitted if

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an approved animal drug can be used (iv) Take appropriate measures to as- for the compounding; sure that assigned timeframes for with- (3) The compounding is performed by drawal are met and no illegal drug resi- a licensed pharmacist or veterinarian dues occur in any food-producing ani- within the scope of a professional prac- mal subjected to extralabel treatment. tice; (b) The following additional condi- (4) Adequate procedures and proc- tions must be met for a permitted esses are followed that ensure the safe- extralabel use of in food-producing ani- ty and effectiveness of the compounded mals an approved human drug, or of an product; animal drug approved only for use in (5) The scale of the compounding op- animals not intended for human con- eration is commensurate with the es- sumption: tablished need for compounded prod- (1) Such use must be accomplished in ucts (e.g., similar to that of com- accordance with an appropriate med- parable practices); and ical rationale; and (6) All relevant State laws relating to (2) If scientific information on the the compounding of drugs for use in human food safety aspect of the use of animals are followed. the drug in food-producing animals is (c) Guidance on the subject of not available, the veterinarian must compounding may be found in guidance take appropriate measures to assure documents issued by FDA. that the animal and its food products will not enter the human food supply. Subpart C—Specific Provisions Re- (c) Extralabel use of an approved lating to Extralabel Use of Ani- human drug in a food-producing animal mal and Human Drugs in is not permitted under this part if an Food-Producing Animals animal drug approved for use in food- producing animals can be used in an § 530.20 Conditions for permitted extralabel manner for the particular extralabel animal and human drug use. use in food-producing animals. (a) The following conditions must be § 530.21 Prohibitions for food-pro- met for a permitted extralabel use in ducing animals. food-producing animals of approved (a) FDA may prohibit the extralabel new animal and human drugs: use of an approved new animal or (1) There is no approved new animal human drug or class of drugs in food- drug that is labeled for such use and producing animals if FDA determines that contains the same active ingre- that: dient which is in the required dosage (1) An acceptable analytical method form and concentration, except where a needs to be established and such meth- veterinarian finds, within the context od has not been established or cannot of a valid veterinarian-client-patient be established; or relationship, that the approved new (2) The extralabel use of the drug or animal drug is clinically ineffective for class of drugs presents a risk to the its intended use. public health. (2) Prior to prescribing or dispensing (b) A prohibition may be a general an approved new animal or human drug ban on the extralabel use of the drug or for an extralabel use in food animals, class of drugs or may be limited to a the veterinarian must: specific species, indication, dosage (i) Make a careful diagnosis and eval- form, route of administration, or com- uation of the conditions for which the bination of factors. drug is to be used; (ii) Establish a substantially ex- § 530.22 Safe levels and analytical tended withdrawal period prior to mar- methods for food-producing ani- keting of milk, meat, eggs, or other ed- mals. ible products supported by appropriate (a) FDA may establish a safe level for scientific information, if applicable; extralabel use of an approved human (iii) Institute procedures to assure drug or an approved new animal drug that the identity of the treated animal when the agency finds that there is a or animals is carefully maintained; and reasonable probability that an

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extralabel use may present a risk to specific analytical method or methods the public health. FDA may: for drug residue detection will be codi- (1) Establish a finite safe level based fied in § 530.40. on residue and metabolism information from available sources; § 530.24 Procedure for announcing an- (2) Establish a safe level based on the alytical methods for drug residue lowest level that can be measured by a quantification. practical analytical method; or (a) FDA may issue an order announc- (3) Establish a safe level based on ing a specific analytical method or other appropriate scientific, technical, methods for the quantification of or regulatory criteria. extralabel use drug residues above the (b) FDA may require the develop- safe levels established under § 530.22 for ment of an acceptable analytical meth- extralabel use of an approved human od for the quantification of residues drug or an approved animal drug. The above any safe level established under agency will publish in the FEDERAL this part. If FDA requires the develop- REGISTER a notice of the order, includ- ment of such an acceptable analytical ing the name of the specific analytical method, the agency will publish notice method or methods and the drug or of that requirement in the FEDERAL drugs for which the method is applica- REGISTER. ble. (c) The extralabel use of an animal (b) Copies of analytical methods for drug or human drug that results in res- the quantification of extralabel use idues exceeding a safe level established drug residues above the safe levels es- under this part is an unsafe use of such tablished under § 530.22 will be available drug. upon request from the Communications (d) If the agency establishes a safe and Education Branch (HFV–12), Divi- level for a particular species or cat- sion of Program Communication and egory of animals and a tolerance or Administrative Management, Center safe concentration is later established for Veterinary Medicine, 7500 Standish through an approval for that particular Pl., Rockville, MD 20855. When an ana- species or category of animals, for that lytical method for the detection of species or category of animals, the safe extralabel use drug residues above the level is superseded by the tolerance or safe levels established under § 530.22 is safe concentration for that species or developed, and that method is accept- category of animals. able to the agency, FDA will incor- § 530.23 Procedure for setting and an- porate that method by reference. nouncing safe levels. § 530.25 Orders prohibiting extralabel (a) FDA may issue an order estab- uses for drugs in food-producing lishing a safe level for a residue of an animals. extralabel use of an approved human drug or an approved animal drug. The (a) FDA may issue an order prohibiting extralabel use of an approved new agency will publish in the FEDERAL animal or human drug in food-pro- REGISTER a notice of the order. The notice will include: ducing animals if the agency finds, (1) A statement setting forth the after providing an opportunity for pub- agency’s finding that there is a reason- lic comment, that: able probability that extralabel use in (1) An acceptable analytical method animals of the human drug or animal required under § 530.22 has not been de- drug may present a risk to the public veloped, submitted, and found to be ac- health; ceptable by FDA or that such method (2) A statement of the basis for that cannot be established; or finding; and (2) The extralabel use in animals pre- (3) A request for public comments. sents a risk to the public health. (b) A current listing of those drugs (b) After making a determination for which a safe level for extralabel that the analytical method required drug use in food-producing animals has under § 530.22 has not been developed been established, the specific safe lev- and submitted, or that such method els, and the availability, if any, of a cannot be established, or that an

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extralabel use in animals of a par- tion was based on incorrect data), FDA ticular human drug or animal drug pre- may, by publication of an appropriate sents a risk to the public health, FDA notice in the FEDERAL REGISTER, re- will publish in the FEDERAL REGISTER, move a drug from the list of human with a 90-day delayed effective date, an and animal drugs prohibited for order of prohibition for an extralabel extralabel use in animals, or may mod- use of a drug in food-producing ani- ify a prohibition. mals. Such order shall state that an ac- (h) FDA may prohibit extralabel use ceptable analytical method required of a drug in food-producing animals under § 530.22 has not been developed, without establishing a safe level. submitted, and found to be acceptable by FDA; that such method cannot be Subpart D—Extralabel Use of established; or that the extralabel use Human and Animal Drugs in in animals presents a risk to the public Animals Not Intended for health; and shall: (1) Specify the nature and extent of Human Consumption the order of prohibition and the rea- § 530.30 Extralabel drug use in sons for the prohibition; nonfood animals. (2) Request public comments; and (a) Because extralabel use of animal (3) Provide a period of not less than and human drugs in nonfood-producing 60 days for comments. animals does not ordinarily pose a (c) The order of prohibition will be- threat to the public health, extralabel come effective 90 days after date of use of animal and human drugs is per- publication of the order unless FDA mitted in nonfood-producing animal publishes a notice in the FEDERAL REG- practice except when the public health ISTER prior to that date, that revokes is threatened. In addition, the provi- the order of prohibition, modifies it, or sions of § 530.20(a)(1) will apply to the extends the period of public comment. use of an approved animal drug. (d) The agency may publish an order (b) If FDA determines that an of prohibition with a shorter comment extralabel drug use in animals not in- period and/or delayed effective date tended for human consumption pre- than specified in paragraph (b) of this sents a risk to the public health, the section in exceptional circumstances agency may publish in the FEDERAL (e.g., where there is immediate risk to REGISTER a notice prohibiting such use the public health), provided that the following the procedures in § 530.25. The order of prohibition states that the prohibited extralabel drug use will be comment period and/or effective date codified in § 530.41. have been abbreviated because there are exceptional circumstances, and the order of prohibition sets forth the Subpart E—Safe Levels for agency’s rationale for taking such ac- Extralabel Use of Drugs in Ani- tion. mals and Drugs Prohibited (e) If FDA publishes a notice in the From Extralabel Use in Ani- FEDERAL REGISTER modifying an order mals of prohibition, the agency will specify in the modified order of prohibition the § 530.40 Safe levels and availability of nature and extent of the modified pro- analytical methods. hibition, the reasons for it, and the (a) In accordance with § 530.22, the agency’s response to any comments on following safe levels for extralabel use the original order of prohibition. of an approved animal drug or human (f) A current listing of drugs prohib- drug have been established: [Reserved] ited for extralabel use in animals will (b) In accordance with § 530.22, the be codified in § 530.41. following analytical methods have (g) After the submission of appro- been accepted by FDA: [Reserved] priate information (i.e., adequate data, an acceptable method, approval of a § 530.41 Drugs prohibited for new animal drug application for the extralabel use in animals. prohibited extralabel use, or informa- (a) The following drugs, families of tion demonstrating that the prohibi- drugs, and substances are prohibited

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for extralabel animal and human drug 556.5 General considerations. uses in food-producing animals. Subpart B—Specific Tolerances for Resi- (1) Chloramphenicol; dues of Approved and Conditionally (2) Clenbuterol; Approved New Animal Drugs (3) Diethylstilbestrol (DES); (4) Dimetridazole; 556.34 Albendazole. (5) Ipronidazole; 556.36 Altrenogest. 556.38 Amoxicillin. (6) Other nitroimidazoles; 556.40 Ampicillin. (7) Furazolidone. 556.50 Amprolium. (8) Nitrofurazone. 556.52 Apramycin. (9) Sulfonamide drugs in lactating 556.60 Avilamycin. 556.68 Azaperone. dairy cattle (except approved use of 556.70 Bacitracin. sulfadimethoxine, 556.75 Bambermycins. sulfabromomethazine, and 556.100 Carbadox. sulfaethoxypyridazine); 556.110 Carbomycin. (10) Fluoroquinolones; and 556.113 Ceftiofur. 556.115 Cephapirin. (11) Glycopeptides. 556.118 Chloramine-T. (12) Phenylbutazone in female dairy 556.120 Chlorhexidine. cattle 20 months of age or older. 556.150 Chlortetracycline. (13) Cephalosporins (not including 556.160 Clopidol. cephapirin) in cattle, swine, chickens, 556.163 Clorsulon. 556.165 Cloxacillin. or turkeys: 556.167 Colistimethate. (i) For disease prevention purposes; 556.169 Danofloxacin. (ii) At unapproved doses, frequencies, 556.170 Decoquinate. durations, or routes of administration; 556.180 Dichlorvos. 556.185 Diclazuril. or 556.200 Dihydrostreptomycin. (iii) If the drug is not approved for 556.222 Doramectin. that species and production class. 556.224 Efrotomycin. (b) The following drugs, families of 556.226 Enrofloxacin. drugs, and substances are prohibited 556.227 Eprinomectin. 556.230 Erythromycin. for extralabel animal and human drug 556.240 Estradiol and related esters. uses in nonfood-producing animals: 556.260 Ethopabate. [Reserved] 556.273 Famphur. (c) [Reserved] 556.275 Fenbendazole. (d) The following drugs, or classes of 556.277 Fenprostalene. 556.280 Fenthion. drugs, that are approved for treating or 556.283 Florfenicol. preventing influenza A, are prohibited 556.286 Flunixin. from extralabel use in chickens, tur- 556.292 Gamithromycin. keys, and ducks: 556.300 Gentamicin. (1) Adamantanes. 556.304 Gonadotropin. 556.308 Halofuginone. (2) Neuraminidase inhibitors. 556.310 Haloxon. 556.316 Hetacillin. [62 FR 27947, May 22, 1997, as amended at 67 556.330 Hygromycin B. FR 5471, Feb. 6, 2002; 68 FR 9530, Feb. 28, 2003; 556.344 Ivermectin. 68 FR 14134, Mar. 24, 2003; 71 FR 14377, Mar. 556.346 Laidlomycin. 22, 2006; 77 FR 745, Jan. 6, 2012] 556.347 Lasalocid. 556.350 Levamisole. PART 556—TOLERANCES FOR RESI- 556.360 Lincomycin. 556.370 Lubabegron. DUES OF NEW ANIMAL DRUGS IN 556.375 Maduramicin. FOOD 556.380 Melengestrol. 556.410 Metoserpate. Subpart A—General Provisions 556.420 Monensin. 556.425 Morantel. Sec. 556.426 Moxidectin. 556.1 Scope. 556.428 Narasin. 556.3 Definitions. 556.430 Neomycin. 556.445 Nicarbazin.

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556.460 Novobiocin. new animal drugs are codified in sub- 556.470 Nystatin. part B of this part. 556.490 Ormetoprim. (b) Compounds that have been found 556.495 Oxfendazole. to be carcinogenic are regulated under 556.500 Oxytetracycline. 556.510 Penicillin. subpart E of part 500 of this chapter. 556.515 Pirlimycin. 556.517 Poloxalene. § 556.3 Definitions. 556.540 Progesterone. As used in this part: 556.560 Pyrantel. Acceptable daily intake (ADI) means 556.570 Ractopamine. the daily intake which, during up to an 556.580 Robenidine. 556.592 Salinomycin. entire life of a human, appears to be 556.597 Semduramicin. without adverse effects or harm to the 556.600 Spectinomycin. health of the consumer. The ADI most 556.610 Streptomycin. often will be set on the basis of the 556.620 Sulfabromomethazine. drug’s toxicological, microbiological, 556.625 Sulfachloropyrazine. or pharmacological properties. It is 556.630 Sulfachlorpyridazine. usually expressed in micrograms or 556.640 Sulfadimethoxine. milligrams of the chemical per kilo- 556.650 Sulfaethoxypyridazine. gram of body weight per day. 556.660 Sulfamerazine. 556.670 Sulfamethazine. Acute reference dose (ARfD) means an 556.685 Sulfaquinoxaline. estimate of the amount of residues ex- 556.700 Sulfomyxin. pressed on a body weight basis that can 556.710 Testosterone. be ingested in a period of 24 hours or 556.720 Tetracycline. less without adverse effects or harm to 556.730 Thiabendazole. the health of the human consumer. 556.732 Tiamulin. Edible tissues means muscle, liver, 556.733 Tildipirosin. kidney, fat, skin with fat in natural 556.735 Tilmicosin. 556.739 Trenbolone. proportions, whole eggs, whole milk, 556.741 Tripelennamine. and honey. 556.745 Tulathromycin. Marker residue means the residue 556.746 Tylosin. whose concentration is in a known re- 556.748 Tylvalosin. lationship to the concentration of total 556.750 Virginiamycin. residue in an edible tissue. 556.760 Zeranol. mg/kg means milligrams per kilo- 556.765 Zilpaterol. 556.770 Zoalene. gram. Not required, in reference to toler- AUTHORITY: 21 U.S.C. 342, 360b, 371. ances in this part, means that at the SOURCE: 84 FR 32993, July 11, 2019, unless time of approval: otherwise noted. (1) No withdrawal period was necessary for residues of the drug to de- Subpart A—General Provisions plete to or below the concentrations considered to be safe, or an adequate § 556.1 Scope. withdrawal period was inherent in the (a) The Federal Food, Drug, and Cos- proposed drug use, and there was a metic Act requires an applicant seek- rapid depletion of residues, so there ing approval or conditional approval of was no concern about residues result- a new animal drug to submit a pro- ing from misuse or overdosing; or posed tolerance as part of its new ani- (2) No withdrawal period was nec- mal drug application when such a tol- essary because the drug was poorly ab- erance is needed to assure that the pro- sorbed or metabolized rapidly so as to posed use of the new animal drug will make selection of an analyte imprac- be safe (see sections 512(b)(1)(H) and tical or impossible. 571(a)(2)(A) of the Federal Food, Drug, ppb means parts per billion (equiva- and Cosmetic Act). FDA assigns toler- lent to nanograms per gram (ng/g) or ances for animal drugs used in food- μg/kg). producing animals as part of the appli- ppm means parts per million (equiva- cation approval process. Tolerances for lent to micrograms per gram (μg/g) or approved and conditionally approved mg/kg).

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ppt means parts per trillion (equiva- other edible tissues from the tested lent to picograms per gram (pg/g) or animal. nanograms per kilogram (ng/kg)). (d) FDA requires that a drug sponsor Residue means any compound present submit a practicable method as part of in edible tissues that results from the their new animal drug application. use of a drug, and includes the drug, its FDA uses the practicable method to de- metabolites, and any other substance termine the quantity of the drug resi- formed in or on food because of the dues that can safely remain in edible drug’s use. tissues (i.e., the tolerance), the with- Target tissue means the edible tissue drawal period, and any other use re- selected to monitor for residues in the strictions necessary to ensure that the target animals. proposed use of the drug will be safe. Tolerance means the maximum concentration of a marker residue, or Subpart B—Specific Tolerances for other residue indicated for monitoring, Residues of Approved and that can legally remain in a specific Conditionally Approved New edible tissue of a treated animal. Animal Drugs Total residue means the aggregate of all compounds that results from the § 556.34 Albendazole. use of an animal drug, including the drug, its metabolites, and any other (a) Acceptable daily intake (ADI). The substances formed in or on food be- ADI for total residue of albendazole is μ cause of such drug use. 5 g/kg of body weight per day. μg/kg means microgram per kilogram. (b) Tolerances. The tolerances for Zero, in reference to tolerances in albendazole 2-aminosulfone (marker this part, means any residues detected residue) are: in the edible tissue renders it unsafe. (1) Cattle. (i) Liver (target tissue): 0.2 ppm. § 556.5 General considerations. (ii) Muscle: 0.05 ppm. (a) The tolerances listed in subpart B (2) Sheep. (i) Liver (target tissue): 0.25 of this part pertain only to the species ppm. and production classes of the animal (ii) Muscle: 0.05 ppm. for which the drug use has been ap- (3) Goat. (i) Liver (target tissue): 0.25 proved or conditionally approved. Ap- ppm. proved and conditionally approved con- (ii) [Reserved] ditions of use in parts 516, 520, 522, 524, (c) Related conditions of use. See 526, 529, and 558 of this chapter, includ- §§ 520.38a and 520.38b of this chapter. ing the species and production classes of animals, are referenced in each tol- § 556.36 Altrenogest. erance section in subpart B of this (a) Acceptable daily intake (ADI). The part. ADI for total residue of altrenogest is (b) All tolerances refer to the con- 0.04 μg/kg of body weight per day. centrations of a marker residue, or (b) Tolerances. The tolerances for other residue indicated for monitoring, altrenogest (marker residue) are: permitted in uncooked tissues. (1) Swine. (i) Liver (target tissue): 4 (c) After a tolerance is listed, the ppb. finding that the concentration of the (ii) Muscle: 1 ppb. marker residue in the target tissue (2) [Reserved] from a tested animal is at or below the (c) Related conditions of use. See tolerance indicates that all edible tis- § 520.48 of this chapter. sues (excluding milk and eggs unless otherwise indicated) from that tested § 556.38 Amoxicillin. animal are safe for human consumption. If a listed tolerance is not ex- (a) [Reserved] pressly linked to a target tissue, then (b) Tolerances. The tolerance for the tolerance is specific only for the amoxicillin is: named edible tissue and inferences can- (1) Cattle. Edible tissues: 0.01 ppm. not be made about the safety of the (2) [Reserved]

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(c) Related conditions of use. See § 556.68 Azaperone. §§ 520.88d, 522.88, and 526.88 of this chap- (a) Acceptable daily intake (ADI). The ter. ADI for total residue of azaperone is μ § 556.40 Ampicillin. 0.63 g/kg of body weight per day. (b) Tolerances. The tolerance for (a) [Reserved] azaperone is: (b) Tolerances. The tolerances for am- (1) Swine. Edible tissues: Not re- picillin are: quired. (1) Cattle. Edible tissues: 0.01 ppm. (2) [Reserved] (2) Swine. Edible tissues: 0.01 ppm. (c) Related conditions of use. See (c) Related conditions of use. See § 522.150 of this chapter. §§ 520.90c, 522.90a, and 522.90b of this chapter. § 556.70 Bacitracin. [84 FR 32993, July 11, 2019, as amended at 85 (a) Acceptable daily intake (ADI). The FR 18120, Apr. 1, 2020] ADI for total residue of bacitracin is 0.05 mg/kg of body weight per day. § 556.50 Amprolium. (b) Tolerances. The tolerances for bac- (a) [Reserved] itracin are: (b) Tolerances. The tolerances for (1) Cattle. Edible tissues: 0.5 ppm. amprolium are: (2) Chickens, turkeys, pheasants, quail. (1) Cattle. (i) Liver, kidney, and mus- Edible tissues: 0.5 ppm. cle: 0.5 ppm. (3) Swine. Edible tissues: 0.5 ppm. (ii) Fat: 2.0 ppm. (c) Related conditions of use. See (2) Chickens and turkeys. (i) Liver and §§ 520.154a, 520.154c, 558.76, and 558.78 of kidney: 1 ppm. this chapter. (ii) Muscle: 0.5 ppm. (iii) Eggs: § 556.75 Bambermycins. (A) Egg yolks: 8 ppm. (a) [Reserved] (B) Whole eggs: 4 ppm. (b) Tolerances. The tolerances for (3) Pheasants. (i) Liver: 1 ppm. bambermycins are: (ii) Muscle: 0.5 ppm. (1) Cattle. Edible tissues (excluding (c) Related conditions of use. See milk): Not required. §§ 520.100, 558.55, and 558.58 of this chap- (2) Chickens and turkeys. Edible tis- ter. sues (excluding eggs): Not required. (3) Swine. Edible tissues: Not re- § 556.52 Apramycin. quired. (a) Acceptable daily intake (ADI). The (c) Related conditions of use. See ADI for total residue of apramycin is 25 § 558.95 of this chapter. μg/kg of body weight per day. (b) Tolerances. The tolerance for § 556.100 Carbadox. apramycin (marker residue) is: (a) [Reserved] (1) Swine. Kidney (target tissue): 0.1 (b) Tolerances. The tolerance for ppm. quinoxaline-2-carboxylic acid (marker (2) [Reserved] residue) is: (c) Related conditions of use. See (1) Swine. Liver (target tissue): 30 §§ 520.110 and 558.59 of this chapter. ppb. (2) [Reserved] § 556.60 Avilamycin. (c) Related conditions of use. See (a) Acceptable daily intake (ADI). The § 558.115 of this chapter. ADI for total residue of avilamycin is 1.1 mg/kg of body weight per day. § 556.110 Carbomycin. (b) Tolerances. The tolerances for (a) [Reserved] avilamycin are: (b) Tolerances. The tolerance for (1) Chickens. Edible tissues (excluding carbomycin is: eggs): Not required. (1) Chickens. Edible tissues (excluding (2) Swine. Edible tissues: Not re- eggs): Zero. quired. (2) [Reserved] (c) Related conditions of use. See (c) Related conditions of use. See § 558.68 of this chapter. § 520.1660a of this chapter.

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§ 556.113 Ceftiofur. § 556.120 Chlorhexidine. (a) Acceptable daily intake and acute (a) [Reserved] reference dose—(1) Acceptable daily in- (b) Tolerances. The tolerance for take (ADI). The ADI for total residue of chlorhexidine is: ceftiofur is 30 μg/kg of body weight per (1) Cattle. Edible tissues (excluding day. milk): Zero. (2) Acute reference dose (ARfD). The (2) [Reserved] ARfD for total residue of ceftiofur is (c) Related conditions of use. See 0.830 mg/kg of body weight. § 529.400 of this chapter. (b) Tolerances. The tolerances for desfuroylceftiofur (marker residue) § 556.150 Chlortetracycline. are: (a) Acceptable daily intake (ADI). The (1) Cattle. (i) Kidney (target tissue): ADI for total residue of tetracyclines 0.4 ppm. including chlortetracycline, oxytetra- (ii) Liver: 2 ppm. cycline, and tetracycline is 25 μg/kg of (iii) Muscle: 1 ppm. body weight per day. (iv) Milk: 0.1 ppm. (b) Tolerances. The tolerances for the (2) Chickens and turkeys. Edible tis- sum of tetracycline residues are: sues (excluding eggs): Not required. (1) Cattle. (i) Liver: 6 ppm. (3) Goats. (i) Kidney (target tissue): 8 (ii) Kidney and fat: 12 ppm. ppm. (iii) Muscle: 2 ppm. (ii) Liver: 2 ppm. (2) Chickens, turkeys, and ducks. (i) (iii) Muscle: 1 ppm. Liver: 6 ppm. (iv) Milk: 0.1 ppm. (ii) Kidney and fat: 12 ppm. (4) Sheep. Edible tissues (excluding (iii) Muscle: 2 ppm. milk): Not required. (iv) Eggs: 0.4 ppm for chlortetra- (5) Swine. (i) Kidney (target tissue): cycline only. 0.25 ppm. (3) Sheep. (i) Liver: 6 ppm. (ii) Liver: 3 ppm. (ii) Kidney and fat: 12 ppm. (iii) Muscle: 2 ppm. (iii) Muscle: 2 ppm. (c) Related conditions of use. See (4) Swine. (i) Liver: 6 ppm. §§ 522.313a, 522.313b, 522.313c, and 526.313 (ii) Kidney and fat: 12 ppm. of this chapter. (iii) Muscle: 2 ppm. (c) Related conditions of use. See § 556.115 Cephapirin. §§ 520.441, 520.443, 520.445, 558.128, and 558.140 of this chapter. (a) [Reserved] (b) Tolerances. The tolerances for § 556.160 Clopidol. cephapirin are: (a) [Reserved] (1) Cattle. (i) Edible tissues (excluding (b) Tolerances. The tolerances for milk): 0.1 ppm. clopidol are: (ii) Milk: 0.02 ppm. (1) Chickens and turkeys. (i) Liver and (2) [Reserved] kidney: 15 ppm. (c) Related conditions of use. See (ii) Muscle: 5 ppm. §§ 526.363 and 526.365 of this chapter. (2) [Reserved] (c) Related conditions of use. See § 556.118 Chloramine-T. § 558.175 of this chapter. (a) Acceptable daily intake (ADI). The ADI for total residue of chloramine-T § 556.163 Clorsulon. is 5 μg/kg of body weight per day. (a) Acceptable daily intake (ADI). The (b) Tolerances. The tolerance for para- ADI for total residue of clorsulon is 8 toluenesulfonamide (marker residue) μg/kg of body weight per day. is: (b) Tolerances. The tolerances for (1) Fish. Muscle/skin (target tissue): clorsulon (marker residue) are: 0.9 ppm. (1) Cattle. (i) Kidney (target tissue): (2) [Reserved] 1.0 ppm. (c) Related conditions of use. See (ii) Muscle: 0.1 ppm. § 529.382 of this chapter. (2) [Reserved]

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(c) Related conditions of use. See (1) Swine. Edible tissues: 0.1 ppm. §§ 520.462 and 522.1193 of this chapter. (2) [Reserved] (c) Related conditions of use. See § 556.165 Cloxacillin. §§ 520.596 and 558.205 of this chapter. (a) [Reserved] (b) Tolerances. The tolerance for § 556.185 Diclazuril. cloxacillin is: (a) Acceptable daily intake (ADI). The (1) Cattle. Edible tissues: 0.01 ppm. ADI for total residue of diclazuril is 25 (2) [Reserved] μg/kg of body weight per day. (c) Related conditions of use. See (b) Tolerances. The tolerances for §§ 526.464a and 526.464b of this chapter. diclazuril are: [84 FR 32993, July 11, 2019, as amended at 85 (1) Chickens and turkeys. (i) Liver: 3 FR 18121, Apr. 1, 2020] ppm. (ii) Muscle: 0.5 ppm. § 556.167 Colistimethate. (iii) Skin/fat: 1 ppm. (a) [Reserved] (2) [Reserved] (b) Tolerances. The tolerance for (c) Related conditions of use. See colistimethate is: § 558.198 of this chapter. (1) Chickens. Edible tissues (excluding eggs): Not required. § 556.200 Dihydrostreptomycin. (2) [Reserved] (a) [Reserved] (c) Related conditions of use. See (b) Tolerances. The tolerances for di- § 522.468 of this chapter. hydrostreptomycin are: (1) Cattle. (i) Kidney: 2.0 ppm. § 556.169 Danofloxacin. (ii) Other edible tissues (excluding (a) Acceptable daily intake (ADI). The milk): 0.5 ppm. ADI for total residue of danofloxacin is (iii) Milk: 0.125 ppm. μ 2.4 g/kg of body weight per day. (2) Swine. (i) Kidney: 2.0 ppm. (b) Tolerances. The tolerances for (ii) Other edible tissues: 0.5 ppm. danofloxacin (marker residue) are: (c) Related conditions of use. See (1) Cattle. (i) Liver (target tissue): 0.2 §§ 522.650, 526.1696b, and 526.1696c of this ppm. chapter. (ii) Muscle: 0.2 ppm. (2) [Reserved] § 556.222 Doramectin. (c) Related conditions of use. See § 522.522 of this chapter. (a) Acceptable daily intake (ADI). The ADI for total residue of doramectin is § 556.170 Decoquinate. 0.75 μg/kg of body weight per day. (a) Acceptable daily intake (ADI). The (b) Tolerances. The tolerances for ADI for total residue of decoquinate is doramectin (marker residue) are: 75 μg/kg of body weight per day. (1) Cattle. (i) Liver (target tissue): 100 (b) Tolerances. The tolerances for ppb. decoquinate are: (ii) Muscle: 30 ppb. (1) Cattle. (i) Muscle: 1 ppm. (2) Swine. Liver (target tissue): 160 (ii) Other edible tissues (excluding ppb. milk): 2 ppm. (c) Related conditions of use. See (2) Chickens. (i) Muscle: 1 ppm. §§ 522.770 and 524.770 of this chapter. (ii) Other edible tissues (excluding eggs): 2 ppm. § 556.224 Efrotomycin. (3) Goats. (i) Muscle: 1 ppm. (a) Acceptable daily intake (ADI). The (ii) Other edible tissues (excluding ADI for total residue of efrotomycin is milk): 2 ppm. 10 μg/kg of body weight per day. (c) Related conditions of use. See (b) Tolerances. The tolerance for §§ 520.543 and 558.195 of this chapter. efrotomycin is: (1) Swine. Edible tissues: Not re- § 556.180 Dichlorvos. quired. (a) [Reserved] (2) [Reserved] (b) Tolerances. The tolerance for (c) Related conditions of use. See dichlorvos is: § 558.235 of this chapter.

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§ 556.226 Enrofloxacin. (c) Related conditions of use. See §§ 522.840, 522.842, 522.850, 522.1940, (a) Acceptable daily intake (ADI). The 522.2477, and 522.2478 of this chapter. ADI for total residue of enrofloxacin is μ 3 g/kg of body weight per day. § 556.260 Ethopabate. (b) Tolerances. The tolerances for enrofloxacin are: (a) [Reserved] (1) Cattle. Liver (target tissue): 0.1 (b) Tolerances. The tolerances for ppm desethylene ciprofloxacin (marker ethopabate, measured as residue). metaphenetidine, are: (2) Swine. Liver (target tissue): 0.5 (1) Chickens. (i) Liver: 1.5 ppm. ppm enrofloxacin (marker residue). (ii) Kidney: 1.5 ppm. (c) Related conditions of use. See (iii) Muscle: 0.5 ppm. § 522.812 of this chapter. (2) [Reserved] (c) Related conditions of use. See § 556.227 Eprinomectin. § 558.58 of this chapter. (a) Acceptable daily intake (ADI). The § 556.273 Famphur. ADI for total residue of eprinomectin is 10 μg/kg of body weight per day. (a) [Reserved] (b) Tolerances. The tolerances for (b) Tolerances. The tolerance for famphur including its oxygen analog is: eprinomectin B1a (marker residue) are: (1) Cattle. (i) Liver (target tissue): 1.5 (1) Cattle. Edible tissues (excluding ppm. milk): 0.1 ppm. (ii) Muscle: 100 ppb. (2) [Reserved] (iii) Milk: 12 ppb. (c) Related conditions of use. See (2) [Reserved] §§ 520.1242g, 524.900, and 558.254 of this (c) Related conditions of use. See chapter. §§ 522.814 and 524.814 of this chapter. § 556.275 Fenbendazole. § 556.230 Erythromycin. (a) Acceptable daily intake (ADI). The (a) [Reserved] ADI for total residue of fenbendazole is 40 μg/kg of body weight per day. (b) Tolerances. The tolerances for erythromycin are: (b) Tolerances. The tolerances for fenbendazole are: (1) Cattle. (i) Edible tissues (excluding milk): 0.1 ppm. (1) Cattle. (i) Liver (target tissue): 0.8 ppm fenbendazole (marker residue). (ii) Milk: Zero. (ii) Muscle: 0.4 ppm fenbendazole. (2) Chickens and turkeys. (i) Edible tissues (excluding eggs): 0.125 ppm. (iii) Milk: 0.6 ppm fenbendazole sulfoxide. (ii) Eggs: 0.025 ppm. (2) Chickens. (i) Liver (target tissue): (c) Related conditions of use. See 5.2 ppm fenbendazole sulfone (marker §§ 520.823, 522.820, 526.820, and 558.248 of residue). this chapter. (ii) Eggs: 1.8 ppm fenbendazole [84 FR 32993, July 11, 2019, as amended at 85 sulfone (marker residue). FR 18121, Apr. 1, 2020] (3) Goats. (i) Liver (target tissue): 0.8 ppm fenbendazole (marker residue). § 556.240 Estradiol and related esters. (ii) Muscle: 0.4 ppm fenbendazole. (a) [Reserved] (4) Swine. (i) Liver (target tissue): 3.2 (b) Residues. Residues of estradiol are ppm fenbendazole (marker residue). not permitted in excess of the fol- (ii) Muscle: 2 ppm fenbendazole. lowing increments above the con- (5) Turkeys. (i) Liver (target tissue): 6 centrations of estradiol naturally ppm fenbendazole sulfone (marker res- present in untreated animals: idue). (1) Cattle. (i) Muscle: 120 ppt. (ii) Muscle: 2 ppm fenbendazole (ii) Fat: 480 ppt. sulfone. (iii) Kidney: 360 ppt. (c) Related conditions of use. See (iv) Liver: 240 ppt. §§ 520.905a, 520.905c, 520.905d, 520.905e, (2) [Reserved] and 558.258 of this chapter.

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§ 556.277 Fenprostalene. (c) Related conditions of use. See (a) Acceptable daily intake (ADI). The §§ 522.956, 522.970, 522.1664, and 524.970 of ADI for total residue of fenprostalene this chapter. μ is 0.08 g/kg of body weight per day. § 556.292 Gamithromycin. (b) Tolerances. The tolerances for fenprostalene are: (a) Acceptable daily intake (ADI). The (1) Cattle. Edible tissues (excluding ADI for total residue of gamithromycin milk): Not required. is 10 μg/kg of body weight per day. (2) Swine. Edible tissues: Not re- (b) Tolerances. The tolerances for quired. gamithromycin (marker residue) are: (c) Related conditions of use. See (1) Cattle. (i) Liver (target tissue): 500 § 522.914 of this chapter. ppb. (ii) Muscle: 150 ppb. § 556.280 Fenthion. (2) [Reserved] (a) [Reserved] (c) Related conditions of use. See (b) Tolerances. The tolerance for § 522.1014 of this chapter. fenthion is: (1) Cattle. Edible tissues (excluding § 556.300 Gentamicin. milk): 0.1 ppm. (a) Acceptable daily intake (ADI). The (2) [Reserved] ADI for total residue of gentamicin is (c) Related conditions of use. See 60 μg/kg of body weight per day. § 524.920 of this chapter. (b) Tolerances. The tolerances for gentamicin are: § 556.283 Florfenicol. (1) Chickens and turkeys. Edible tis- (a) Acceptable daily intake (ADI). The sues (excluding eggs): 0.1 ppm. ADI for total residue of florfenicol is 10 (2) Swine. (i) Liver: 0.3 ppm. μg/kg of body weight per day. (ii) Kidney (target tissue): 0.4 ppm (b) Tolerances. The tolerances for gentamicin (marker residue). florfenicol amine (marker residue) are: (iii) Fat: 0.4 ppm. (1) Cattle. (i) Liver (target tissue): 3.7 (iv) Muscle: 0.1 ppm. ppm. (c) Related conditions of use. See (ii) Muscle: 0.3 ppm. §§ 522.1044a, 520.1044b, 520.1044c, and (2) Swine. (i) Liver (target tissue): 2.5 524.1044e of this chapter. ppm. (ii) Muscle: 0.2 ppm. § 556.304 Gonadotropin. (3) Catfish. Muscle (target tissue): 1 (a) Acceptable daily intake (ADI). The ppm. ADI for residues of total gonadotropins (4) Freshwater-reared warmwater (human chorionic gonadotropin and finfish (other than catfish) and pregnant mare serum gonadotropin) is Muscle/skin (target tissue): 1 salmonids. 42.25 International Units per kilogram ppm. of body weight per day. (c) Related conditions of use. See (b) Tolerances. The tolerances for §§ 520.955, 522.955, 522.956, and 558.261 of gonadotropin are: this chapter. (1) Cattle. Edible tissues (excluding § 556.286 Flunixin. milk): Not required. (2) Fish. Edible tissues: Not required. (a) Acceptable daily intake (ADI). The (3) Swine. Edible tissues: Not re- ADI for total residue of flunixin is 0.72 μ quired. g/kg of body weight per day. (c) Related conditions of use. See (b) The tolerances for Tolerances. §§ 522.1079 and 522.1081 of this chapter. flunixin are: (1) Cattle. (i) Liver (target tissue): 125 [84 FR 32993, July 11, 2019, as amended at 85 ppb flunixin free acid (marker residue). FR 18121, Apr. 1, 2020] (ii) Muscle: 25 ppb flunixin free acid. (iii) Milk: 2 ppb 5-hydroxy flunixin § 556.308 Halofuginone. (marker residue). (a) Acceptable daily intake (ADI). The (2) Swine. (i) Liver (target tissue): 30 ADI for total residue of halofuginone ppb flunixin free acid (marker residue). hydrobromide is 0.7 μg/kg of body (ii) Muscle: 25 ppb flunixin free acid. weight per day.

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(b) Tolerances. The tolerances for (c) Related conditions of use. See halofuginone (marker residue) are: §§ 520.1192, 520.1195, 520.1197, 522.1192, (1) Chickens. Liver (target tissue): 0.16 522.1193, 524.1193, and 558.300 of this ppm. chapter. (2) Turkeys. Liver (target tissue): 0.13 [84 FR 32993, July 11, 2019, as amended at 85 ppm. FR 18121, Apr. 1, 2020] (c) Related conditions of use. See § 558.265 of this chapter. § 556.346 Laidlomycin. § 556.310 Haloxon. (a) Acceptable daily intake (ADI). The ADI for total residue of laidlomycin is (a) [Reserved] 7.5 μg/kg of body weight per day. (b) Tolerances. The tolerance for (b) Tolerances. The tolerance for haloxon is: laidlomycin (marker residue) is: (1) Cattle. Edible tissues (excluding (1) Cattle. Liver (target tissue): 0.2 milk): 0.1 ppm. ppm. (2) [Reserved] (2) [Reserved] (c) Related conditions of use. See (c) Related conditions of use. See §§ 520.1120a and 520.1120b of this chapter. § 558.305 of this chapter.

§ 556.316 Hetacillin. § 556.347 Lasalocid. (a) [Reserved] (a) Acceptable daily intake (ADI). The (b) Tolerances. The tolerances for am- ADI for total residue of lasalocid is 10 picillin (marker residue for hetacillin) μg/kg of body weight per day. are: (b) Tolerances. The tolerances for (1) Cattle. Edible tissues: 0.01 ppm. lasalocid (marker residue) are: (2) [Reserved] (1) Cattle. Liver (target tissue): 0.7 (c) Related conditions of use. See ppm. § 526.1130 of this chapter. (2) Chickens. (i) Skin with adhering [84 FR 53311, Oct. 7, 2019] fat (target tissue): 1.2 ppm. (ii) Liver: 0.4 ppm. § 556.330 Hygromycin B. (3) Rabbits. Liver (target tissue): 0.7 (a) [Reserved] ppm. (b) Tolerances. The tolerances for (4) Sheep. Liver (target tissue): 1.0 hygromycin B are: ppm. (1) Chickens. Edible tissues: Zero. (5) Turkeys. (i) Liver (target tissue): (2) Swine. Edible tissues: Zero. 0.4 ppm. (c) Related conditions of use. See (ii) Skin with adhering fat: 0.4 ppm. § 558.274 of this chapter. (c) Related conditions of use. See § 558.311 of this chapter. § 556.344 Ivermectin. (a) Acceptable daily intake (ADI). The § 556.350 Levamisole. ADI for total residue of ivermectin is 5 (a) [Reserved] μg/kg of body weight per day. (b) Tolerances. The tolerances for (b) Tolerances. The tolerances for levamisole are: 22,23-dihydroavermectin B1a (marker (1) Cattle. Edible tissues (excluding residue) are: milk): 0.1 ppm. (1) American bison. Liver (target tis- (2) Sheep. Edible tissues (excluding sue): 15 ppb. milk): 0.1 ppm. (2) Cattle. (i) Liver (target tissue): 1.6 (3) Swine. Edible tissues: 0.1 ppm. ppm. (c) Related conditions of use. See (ii) Muscle: 650 ppb. §§ 520.1242a, 520.1242b, 520.1242d, (3) Reindeer. Liver (target tissue): 15 520.1242e, 520.1242f, 520.1242g, 522.1242, ppb. and 524.1240 of this chapter. (4) Sheep. Liver (target tissue): 30 ppb. § 556.360 Lincomycin. (5) Swine. (i) Liver (target tissue): 20 (a) Acceptable daily intake (ADI). The ppb. ADI for total residue of lincomycin is (ii) Muscle: 20 ppb. 25 μg/kg of body weight per day.

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(b) Tolerances. The tolerances for lin- § 556.420 Monensin. comycin are: (a) Acceptable daily intake (ADI). The (1) Chickens. Edible tissues (excluding ADI for total residue of monensin is eggs): Not required. 12.5 μg/kg of body weight per day. (2) Swine. (i) Liver: 0.6 ppm. (b) Tolerances. The tolerances for (ii) Muscle: 0.1 ppm. monensin are: (3) Honey. 750 ppb. (1) Cattle. (i) Liver: 0.10 ppm. (c) Related conditions of use. See (ii) Muscle, kidney, and fat: 0.05 ppm. §§ 520.1263b, 522.1260, and 558.325 of this (iii) Milk: Not required. chapter. (2) Chickens and turkeys. Edible tissues (excluding eggs): Not required. [84 FR 32993, July 11, 2019, as amended at 85 (3) Goats. Edible tissues (excluding FR 18121, Apr. 1, 2020] milk): 0.05 ppm. (4) Quail. Edible tissues (excluding § 556.370 Lubabegron. eggs): Not required. (a) Acceptable daily intake (ADI). The (c) Related conditions of use. See ADI for total residues of lubabegron is § 558.355 of this chapter. 3 micrograms per kilogram of body weight per day. § 556.425 Morantel. (b) Tolerances. The tolerance for (a) Acceptable daily intake (ADI). The lubabegron (marker residue) is: ADI for total residue of morantel tar- (1) Cattle. Liver (target tissue): 10 trate is 10 μg/kg of body weight per ppb. day. (2) [Reserved] (b) Tolerances. The tolerances for N- (c) Related conditions of use. See methyl-1,3-propanediamine (marker § 558.330 of this chapter. residue) are: (1) Cattle. (i) Liver (target tissue): 0.7 [84 FR 12494, Apr. 2, 2019] ppm. (ii) Milk: Not required. § 556.375 Maduramicin. (2) Goats. (i) Liver (target tissue): 0.7 (a) [Reserved] ppm. (b) Tolerances. The tolerance for (ii) Milk: Not required. maduramicin (marker residue) is: (c) Related conditions of use. See §§ 520.1450a, 520.1450b, 520.1450c, and (1) Chickens. Fat (target tissue): 0.38 558.360 of this chapter. ppm. (2) [Reserved] § 556.426 Moxidectin. (c) Related conditions of use. See (a) Acceptable daily intake (ADI). The § 558.340 of this chapter. ADI for total residue of moxidectin is 4 μg/kg of body weight per day. § 556.380 Melengestrol. (b) Tolerances. The tolerances for (a) [Reserved] moxidectin (marker residue) are: (b) Tolerances. The tolerance for (1) Cattle. (i) Fat (target tissue): 900 melengestrol is: ppb. (1) Cattle. Fat: 25 ppb. (ii) Liver: 200 ppb. (2) [Reserved] (iii) Muscle: 50 ppb. (c) Related conditions of use. See (iv) Milk: 40 ppb. § 558.342 of this chapter. (2) Sheep. (i) Fat (target tissue): 900 ppb. § 556.410 Metoserpate. (ii) Liver: 200 ppb. (iii) Muscle: 50 ppb. (a) [Reserved] (c) Related conditions of use. See (b) Tolerances. The tolerance for §§ 520.1454, 522.1450, and 524.1450 of this metoserpate is: chapter. (1) Chickens. Edible tissues (excluding eggs): 0.02 ppm. § 556.428 Narasin. (2) [Reserved] (a) Acceptable daily intake (ADI). The (c) Related conditions of use. See ADI for total residue of narasin is 5 μg/ § 520.1422 of this chapter. kg of body weight per day.

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(b) Tolerances. The tolerance for (ii) Milk: 0.1 ppm. narasin (marker residue) is: (2) Chickens, turkeys, and ducks. Edi- (1) Chickens. Abdominal fat (target ble tissues (excluding eggs): 1 ppm. tissue): 480 ppb. (c) Related conditions of use. See (2) [Reserved] §§ 526.1590, 526.1696d, and 558.415 of this (c) Related conditions of use. See chapter. §§ 558.363 and 558.364 of this chapter. § 556.470 Nystatin. § 556.430 Neomycin. (a) [Reserved] (a) Acceptable daily intake (ADI). The (b) Tolerances. The tolerances for nys- ADI for total residue of neomycin is 6 tatin are: μg/kg of body weight per day. (1) Cattle. Edible tissues (excluding (b) Tolerances. The tolerances for neo- milk): Zero. mycin are: (2) Chickens and turkeys. Edible tis- (1) Cattle. (i) Kidney (target tissue): sues: Zero. 7.2 ppm. (c) Related conditions of use. See (ii) Liver: 3.6 ppm. §§ 524.1600b and 558.430 of this chapter. (iii) Muscle: 1.2 ppm. (iv) Fat: 7.2 ppm. § 556.490 Ormetoprim. (v) Milk: 0.15 ppm. (a) [Reserved] (2) Sheep and goats. (i) Kidney (target (b) Tolerances. The tolerances for tissue): 7.2 ppm. ormetoprim are: (ii) Liver: 3.6 ppm. (1) Chickens, turkeys, ducks, and (iii) Muscle: 1.2 ppm. chukar partridges. Edible tissues (ex- (iv) Fat: 7.2 ppm. cluding eggs): 0.1 ppm. (v) Milk: 0.15 ppm. (3) Swine. (i) Kidney (target tissue): (2) Salmonids and catfish. Edible tis- 7.2 ppm. sues: 0.1 ppm. (ii) Liver: 3.6 ppm. (c) Related conditions of use. See (iii) Muscle: 1.2 ppm. § 558.575 of this chapter. (iv) Fat: 7.2 ppm. § 556.495 Oxfendazole. (4) Turkeys. (i) Skin with adhering fat: 7.2 ppm. (a) Acceptable daily intake (ADI). The (ii) Liver: 3.6 ppm. ADI for total residue of oxfendazole is (iii) Muscle: 1.2 ppm. 7 μg/kg of body weight per day. (c) Related conditions of use. See (b) Tolerances. The tolerance for §§ 520.1484, 524.1600b, 558.365, and 558.455 fenbendazole (marker residue) is: of this chapter. (1) Cattle. Liver (target tissue): 0.8 ppm. § 556.445 Nicarbazin. (2) [Reserved] (a) Acceptable daily intake (ADI). The (c) Related conditions of use. See ADI for total residues of nicarbazin §§ 520.1629 and 520.1630 of this chapter. (4,4′-dinitrocarbanilide and 2-hydroxy- 4,6-dimethylpyrimidine) is 200 μg/kg of § 556.500 Oxytetracycline. body weight per day. (a) Acceptable daily intake (ADI). The (b) Tolerances. The tolerance for 4,4′- ADI for total tetracycline residues dinitrocarbanilide (marker residue) is: (chlortetracycline, oxytetracycline, (1) Chickens. Liver (target tissue): 52 and tetracycline) is 25 μg/kg of body ppm. weight per day. (2) [Reserved] (b) Tolerances. The tolerances for the (c) Related conditions of use. See sum of tetracycline residues are: §§ 558.364 and 558.366 of this chapter. (1) Cattle. (i) Muscle: 2 ppm. (ii) Liver: 6 ppm. § 556.460 Novobiocin. (iii) Fat and kidney: 12 ppm. (a) [Reserved] (iv) Milk: 0.3 ppm. (b) Tolerances. The tolerances for (2) Chickens and turkeys. (i) Muscle: 2 novobiocin are: ppm. (1) Cattle. (i) Edible tissues (excluding (ii) Liver: 6 ppm. milk): 1 ppm. (iii) Fat and kidney: 12 ppm.

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(3) Finfish. Muscle (with adhering (c) Related conditions of use. See skin when edible): 2 ppm. §§ 520.1840, 558.464, and 558.465 of this (4) Lobster. Muscle: 2 ppm. chapter. (5) Swine and sheep. (i) Muscle: 2 ppm. (ii) Liver: 6 ppm. § 556.540 Progesterone. (iii) Fat and kidney: 12 ppm. (a) [Reserved] (6) Honey. 750 ppb. (b) Residues. Residues of progesterone (c) Related conditions of use. See are not permitted in excess of the fol- §§ 520.1660a, 520.1660c, 520.1660d, lowing increments above the con- 522.1660a, 522.1660b, 522.1662a, 522.1664, centrations of progesterone naturally 529.1660, 558.450, and 558.455 of this chap- present in untreated animals: ter. (1) Cattle and sheep. (i) Muscle: 5 ppb. (ii) Liver: 15 ppb. [84 FR 32993, July 11, 2019, as amended at 85 (iii) Kidney: 30 ppb. FR 18121, Apr. 1, 2020] (iv) Fat: 30 ppb. (2) [Reserved] § 556.510 Penicillin. (c) Related conditions of use. See (a) [Reserved] §§ 522.1940 and 529.1940 of this chapter. (b) Tolerances. The tolerances for penicillin are: § 556.560 Pyrantel. (1) Cattle. (i) Edible tissues (excluding (a) [Reserved] milk): 0.05 ppm. (b) Tolerances. The tolerances for (ii) Milk: Zero. pyrantel are: (2) Chickens. Edible tissues: Zero. (1) Swine. (i) Liver and kidney: 10 (3) Pheasants and quail. Edible tis- ppm. sues: Zero. (ii) Muscle: 1 ppm. (4) Sheep and swine. Edible tissues: (2) [Reserved] Zero. (c) Related conditions of use. See (5) Turkeys. Edible tissues (excluding §§ 520.2045 and 558.485 of this chapter. eggs): 0.01 ppm. (c) Related conditions of use. See § 556.570 Ractopamine. §§ 520.1696a, 522.1696a, 522.1696b, (a) Acceptable daily intake (ADI). The 526.1696a, 526.1696b, 526.1696c, and ADI for total residue of ractopamine 526.1696d of this chapter. hydrochloride is 1.25 μg/kg of body weight per day. [84 FR 32993, July 11, 2019, as amended at 85 FR 18121, Apr. 1, 2020] (b) Tolerances. The tolerances for ractopamine (marker residue) are: § 556.515 Pirlimycin. (1) Cattle. (i) Liver (target tissue): 0.09 ppm. (a) Acceptable daily intake (ADI). The (ii) Muscle: 0.03 ppm. ADI for total residue of pirlimycin is (2) Swine. (i) Liver (target tissue): 0.15 0.01 mg/kg of body weight per day. ppm. (b) Tolerances. The tolerances for (ii) Muscle: 0.05 ppm. pirlimycin (marker residue) are: (3) Turkeys. (i) Liver (target tissue): (1) Cattle. (i) Liver (target tissue): 0.5 0.45 ppm. ppm. (ii) Muscle: 0.1 ppm. (ii) Muscle: 0.3 ppm. (c) Related conditions of use. See (iii) Milk: 0.4 ppm. § 558.500 of this chapter. (2) [Reserved] (c) Related conditions of use. See § 556.580 Robenidine. § 526.1810 of this chapter. (a) [Reserved] (b) Tolerances. The tolerances for § 556.517 Poloxalene. robenidine are: (a) [Reserved] (1) Chickens. (i) Skin and fat: 0.2 ppm. (b) Tolerances. The tolerance for (ii) Other edible tissues (excluding poloxalene is: eggs): 0.1 ppm. (1) Cattle. Edible tissues (excluding (2) [Reserved] milk): Not required. (c) Related conditions of use. See (2) [Reserved] § 558.515 of this chapter.

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§ 556.592 Salinomycin. (b) Tolerances. The tolerances for sulfabromomethazine are: (a) Acceptable daily intake (ADI). The (1) Cattle. (i) Edible tissues (excluding ADI for total residue of salinomycin is milk): 0.1 ppm. 5 μg/kg of body weight per day. (ii) Milk: 0.01 ppm. (b) Tolerances. The tolerances for (2) [Reserved] salinomycin are: (c) Related conditions of use. See (1) Chickens. Edible tissues (excluding § 520.2170 of this chapter. eggs): Not required. (2) Quail. Edible tissues (excluding § 556.625 Sulfachloropyrazine. eggs): Not required. (a) [Reserved] (c) Related conditions of use. See (b) Tolerances. The tolerance for § 558.550 of this chapter. sulfachloropyrazine is: § 556.597 Semduramicin. (1) Chickens. Edible tissues (excluding eggs): Zero. (a) Acceptable daily intake (ADI). The (2) [Reserved] ADI for total residue of semduramicin (c) Related conditions of use. See is 3 μg/kg of body weight per day. § 520.2184 of this chapter. (b) Tolerances. The tolerances for semduramicin are: § 556.630 Sulfachlorpyridazine. (1) Chickens. (i) Liver: 400 ppb. (a) [Reserved] (ii) Muscle: 130 ppb. (b) Tolerances. The tolerances for (2) [Reserved] sulfachlorpyridazine are: (c) Related conditions of use. See (1) Cattle and swine. Edible tissues § 558.555 of this chapter. (excluding milk): 0.1 ppm. (2) [Reserved] § 556.600 Spectinomycin. (c) Related conditions of use. See (a) Acceptable daily intake (ADI). The §§ 520.2200 and 522.2200 of this chapter. ADI for total residue of spectinomycin is 25 μg/kg of body weight per day. § 556.640 Sulfadimethoxine. (b) Tolerances. The tolerances for (a) [Reserved] spectinomycin are: (b) Tolerances. The tolerances for (1) Cattle. (i) Kidney (target tissue): 4 sulfadimethoxine are: ppm spectinomycin (marker residue). (1) Catfish and salmonids. Edible tis- (ii) Muscle: 0.25 ppm. sues: 0.1 ppm. (2) Chickens and turkeys. Edible tis- (2) Cattle. (i) Edible tissues (excluding sues (excluding eggs): 0.1 ppm. milk): 0.1 ppm. (3) Swine. Edible tissues: Not re- (ii) Milk: 0.01 ppm. quired. (3) Chickens, turkeys, ducks, and (c) Related conditions of use. See chukar partridges. Edible tissues (ex- §§ 520.1265, 520.2123b, 520.2123c, 522.2120, cluding eggs): 0.1 ppm. and 522.2121 of this chapter. (c) Related conditions of use. See §§ 520.2220a, 520.2220d, 520.2220e, 522.2220, § 556.610 Streptomycin. and 558.575 of this chapter. (a) [Reserved] (b) Tolerances. The tolerances for § 556.650 Sulfaethoxypyridazine. streptomycin are: (a) [Reserved] (1) Cattle and swine. (i) Kidney: 2.0 (b) Tolerances. The tolerances for ppm. sulfaethoxypyridazine are: (ii) Other edible tissues (excluding (1) Cattle. (i) Edible tissues (excluding milk): 0.5 ppm. milk): 0.1 ppm. (2) Chickens. (i) Kidney: 2.0 ppm. (ii) Milk: Zero. (ii) Other edible tissues (excluding (2) Swine. Edible tissues: Zero. eggs): 0.5 ppm. (c) Related conditions of use. See (c) Related conditions of use. See §§ 520.2240a, 520.2240b, and 522.2240 of § 520.2158 of this chapter. this chapter.

§ 556.620 Sulfabromomethazine. § 556.660 Sulfamerazine. (a) [Reserved] (a) [Reserved]

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(b) Tolerances. The tolerance for sul- (iii) Liver: 1.3 ppb. famerazine is: (iv) Muscle: 0.64 ppb. (1) Trout. Edible tissues: Zero. (2) [Reserved] (2) [Reserved] (c) Related conditions of use. See (c) Related conditions of use. See § 522.842 of this chapter. §§ 520.2218 and 558.582 of this chapter. [84 FR 32993, July 11, 2019, as amended at 85 § 556.720 Tetracycline. FR 18121, Apr. 1, 2020] (a) Acceptable daily intake (ADI). The ADI for total tetracycline residues § 556.670 Sulfamethazine. (chlortetracycline, oxytetracycline, (a) [Reserved] and tetracycline) is 25 μg/kg of body (b) Tolerances. The tolerances for weight per day. sulfamethazine are: (b) Tolerances. The tolerances for the (1) Cattle. Edible tissues (excluding sum of tetracycline residues are: milk): 0.1 ppm. (1) Cattle and sheep. (i) Kidney and (2) Chickens and turkeys. Edible tis- fat: 12 ppm. sues (excluding eggs): 0.1 ppm. (ii) Liver: 6 ppm. (3) Swine. Edible tissues: 0.1 ppm. (iii) Muscle: 2 ppm. (c) Related conditions of use. See (2) Chickens and turkeys. (i) Kidney §§ 520.2218, 520.2260a, 520.2260b, 520.2260c, and fat: 12 ppm. 520.2261a, 520.2261b, 522.2260, 558.140, and (ii) Liver: 6 ppm. 558.630 of this chapter. (iii) Muscle: 2 ppm. [84 FR 32993, July 11, 2019, as amended at 85 (3) Swine. (i) Kidney and fat: 12 ppm. FR 18121, Apr. 1, 2020] (ii) Liver: 6 ppm. § 556.685 Sulfaquinoxaline. (iii) Muscle: 2 ppm. (c) Related conditions of use. See (a) [Reserved] §§ 520.2345c and 520.2345d of this chapter. (b) Tolerances. The tolerances for sulfaquinoxaline are: § 556.730 Thiabendazole. (1) Cattle. Edible tissues (excluding milk): 0.1 ppm. (a) [Reserved] (2) Chickens and turkeys. Edible tis- (b) Tolerances. The tolerances for sues (excluding eggs): 0.1 ppm. thiabendazole are: (c) Related conditions of use. See (1) Cattle. (i) Edible tissues (excluding §§ 520.2218, 520.2325a, 520.2325b, and milk): 0.1 ppm. 558.586 of this chapter. (ii) Milk: 0.05 ppm. (2) Swine. Edible tissues: 0.1 ppm. [84 FR 32993, July 11, 2019, as amended at 85 (3) Sheep and goats. (i) Edible tissues FR 18121, Apr. 1, 2020] (excluding milk): 0.1 ppm. § 556.700 Sulfomyxin. (ii) Milk: 0.05 ppm. (a) [Reserved] (4) Pheasants. Edible tissues (exclud- (b) Tolerances. The tolerances for ing eggs): 0.1 ppm. sulfomyxin are: (c) Related conditions of use. See (1) Chickens and turkeys. Edible tis- §§ 520.2380a, 520.2380b, 520.2380c, and sues (excluding eggs): Zero. 558.600 of this chapter. (2) [Reserved] § 556.732 Tiamulin. (c) Related conditions of use. See § 522.2340 of this chapter. (a) Acceptable daily intake (ADI). The ADI for total residue of tiamulin is 25 § 556.710 Testosterone. μg/kg of body weight per day. (a) [Reserved] (b) Tolerances. The tolerance for 8- (b) Residues. Residues of testosterone alpha-hydroxymutilin (marker residue) are not permitted in excess of the fol- is: lowing increments above the con- (1) Swine. Liver (target tissue): 0.6 centrations of testosterone naturally ppm. present in untreated animals: (2) [Reserved] (1) Cattle. (i) Fat: 2.6 ppb. (c) Related conditions of use. See (ii) Kidney: 1.9 ppb. §§ 520.2455 and 558.612 of this chapter.

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§ 556.733 Tildipirosin. § 556.745 Tulathromycin. (a) Acceptable daily intake (ADI). The (a) Acceptable daily intake (ADI). The ADI for total residue of tildipirosin is ADI for total residue of tulathromycin 50 μg/kg of body weight per day. is 15 μg/kg of body weight per day. (b) Tolerances. The tolerance for (b) Tolerances. The tolerances for CP– tildipirosin (the marker residue) is: 60,300 (marker residue) are: (1) Cattle. (i) Liver (the target tissue): (1) Cattle. Liver (target tissue): 5.5 10 ppm. ppm. (ii) [Reserved] (2) Swine. Kidney (target tissue): 15 (2) [Reserved] ppm. (c) Related conditions of use. See (c) Related conditions of use. See § 522.2460 of this chapter. § 522.2630 of this chapter. [84 FR 32993, July 11, 2019, as amended at 85 FR 18121, Apr. 1, 2020] § 556.746 Tylosin. (a) [Reserved] § 556.735 Tilmicosin. (b) Tolerances. The tolerances for (a) Acceptable daily intake (ADI). The tylosin are: ADI for total residue of tilmicosin is 25 (1) Cattle. (i) Liver, kidney, fat, and μg/kg of body weight per day. muscle: 0.2 ppm. (b) Tolerances. The tolerances for (ii) Milk: 0.05 ppm. tilmicosin (marker residue) are: (2) Chickens and turkeys. (i) Liver, (1) Cattle. (i) Liver (target tissue): 1.2 kidney, fat, and muscle: 0.2 ppm. ppm. (ii) Eggs: 0.2 ppm. (ii) Muscle: 0.1 ppm. (3) Swine. Liver, kidney, fat, and (2) Sheep. (i) Liver (target tissue): 1.2 muscle: 0.2 ppm. ppm. (4) Honey. 500 ppb. (ii) Muscle: 0.1 ppm. (c) Related conditions of use. See (3) Swine. (i) Liver (target tissue): 7.5 §§ 520.2640, 522.2640, 558.625, and 558.630 of ppm. this chapter. (ii) Muscle: 0.1 ppm. (c) Related conditions of use. See [84 FR 32993, July 11, 2019, as amended at 85 §§ 520.2471, 522.2471, and 558.618 of this FR 18121, Apr. 1, 2020] chapter. § 556.748 Tylvalosin. § 556.739 Trenbolone. (a) Acceptable daily intake (ADI). The (a) Acceptable daily intake (ADI). The ADI for total residues of tylvalosin is μ ADI for total residue of trenbolone is 47.7 g/kg of body weight per day. 0.4 μg/kg of body weight per day. (b) Tolerances. A tolerance for (b) Tolerances. The tolerance for tylvalosin in edible tissues of swine is trenbolone is: not required. (1) Cattle. Edible tissues (excluding (c) Related conditions of use. See milk): Not required. §§ 520.2645 and 558.633 of this chapter. (2) [Reserved] § 556.750 Virginiamycin. (c) Related conditions of use. See §§ 522.2476, 522.2477, and 522.2478 of this (a) Acceptable daily intake (ADI). The chapter. ADI for total residue of virginiamycin is 250 μg/kg of body weight per day. § 556.741 Tripelennamine. (b) Tolerances. The tolerances for (a) [Reserved] virginiamycin are: (b) Tolerances. The tolerances for (1) Cattle. Edible tissues (excluding tripelennamine are: milk): Not required. (1) Cattle. (i) Edible tissues (excluding (2) Chickens. Edible tissues (excluding milk): 200 ppb. eggs): Not required. (ii) Milk: 20 ppb. (3) Swine. (i) Kidney, skin, and fat: 0.4 (2) [Reserved] ppm. (c) Related conditions of use. See (ii) Liver: 0.3 ppm. § 522.2615 of this chapter. (iii) Muscle: 0.1 ppm.

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(c) Related conditions of use. See Subpart B—Specific New Animal Drugs For § 558.635 of this chapter. Use in Animal Feeds [84 FR 32993, July 11, 2019, as amended at 85 558.55 Amprolium. FR 18121, Apr. 1, 2020] 558.58 Amprolium and ethopabate. 558.59 Apramycin. § 556.760 Zeranol. 558.68 Avilamycin. (a) Acceptable daily intake (ADI). The 558.76 Bacitracin methylenedisalicylate. ADI for total residue of zeranol is 1.25 558.78 Bacitracin zinc. μ 558.95 Bambermycins. g/kg of body weight per day. 558.115 Carbadox. (b) Tolerances. The tolerances for 558.128 Chlortetracycline. zeranol are: 558.140 Chlortetracycline and (1) Cattle. Edible tissues (excluding sulfamethazine. milk): Not required. 558.175 Clopidol. (2) Sheep. Edible tissues (excluding 558.195 Decoquinate. milk): 20 ppb. 558.198 Dichlorvos. (c) Related conditions of use. See 558.205 Diclazuril. 558.235 Efrotomycin. § 522.2680 of this chapter. 558.248 Erythromycin. 558.254 Famphur. § 556.765 Zilpaterol. 558.258 Fenbendazole. (a) Acceptable daily intake (ADI). The 558.261 Florfenicol. ADI for total residue of zilpaterol is 558.265 Halofuginone hydrobromide. 0.083 μg/kg of body weight per day. 558.274 Hygromycin B. (b) Tolerances. The tolerance for 558.295 Iodinated casein. 558.300 Ivermectin. zilpaterol freebase (marker residue) is: 558.305 Laidlomycin. (1) Cattle. (i) Liver (target tissue): 12 558.311 Lasalocid. ppb. 558.325 Lincomycin. (ii) Muscle: 10 ppb. 558.330 Lubabegron. (2) [Reserved] 558.340 Maduramicin. (c) Related conditions of use. See 558.342 Melengestrol. § 558.665 of this chapter. 558.348 Mibolerone. 558.355 Monensin. [84 FR 32993, July 11, 2019, as amended at 85 558.360 Morantel. FR 18121, Apr. 1, 2020] 558.363 Narasin. 558.364 Narasin and nicarbazin. § 556.770 Zoalene. 558.365 Neomycin sulfate. (a) [Reserved] 558.366 Nicarbazin. 558.415 Novobiocin. (b) Tolerances. The tolerances for 558.430 Nystatin. zoalene and its metabolite 3-amino-5- 558.450 Oxytetracycline. nitro-o-toluamide are: 558.455 Oxytetracycline and neomycin. (1) Chickens. (i) Liver and kidney: 6 558.464 Poloxalene. ppm. 558.465 Poloxalene free-choice liquid Type C (ii) Muscle: 3 ppm. feed. (iii) Fat: 2 ppm. 558.485 Pyrantel. (2) Turkeys. Liver and muscle: 3 ppm. 558.500 Ractopamine. 558.515 Robenidine. (c) Related conditions of use. See 558.550 Salinomycin. § 558.680 of this chapter. 558.555 Semduramicin. 558.575 Sulfadimethoxine and ormetoprim. PART 558—NEW ANIMAL DRUGS 558.582 Sulfamerazine. 558.586 Sulfaquinoxaline. FOR USE IN ANIMAL FEEDS 558.600 Thiabendazole. 558.612 Tiamulin. Subpart A—General Provisions 558.618 Tilmicosin. 558.625 Tylosin. Sec. 558.630 Tylosin and sulfamethazine. 558.3 Definitions and general considerations 558.633 Tylvalosin. applicable to this part. 558.635 Virginiamycin. 558.4 Requirement of a medicated feed mill 558.665 Zilpaterol. license. 558.680 Zoalene. 558.5 Requirements for liquid medicated feed. AUTHORITY: 21 U.S.C. 354, 360b, 360ccc, 558.6 Veterinary feed directive drugs. 360ccc–1, 371.

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SOURCE: 40 FR 13959, Mar. 27, 1975, unless animal drug(s) in a Type B medicated otherwise noted. feed is 200 times the highest continuous use level for Category I drugs and 100 Subpart A—General Provisions times the highest continuous use level for Category II drugs. The term ‘‘high- § 558.3 Definitions and general consid- est continuous use level’’ means the erations applicable to this part. highest dosage at which the drug is ap- (a) Regulations in this part provide proved for continuous use (14 days or for approved uses of drugs and com- more), or, if the drug is not approved binations of drugs in animal feeds. Ap- for continuous use, it means the high- proved combinations of such drugs are est level used for disease prevention or specifically identified or incorporated control. If the drug is approved for by cross-reference. Unless specifically multiple species at different use levels, provided for by the regulations, a com- the highest approved level of use would bination of two or more drugs is not govern under this definition. The man- approved. ufacture of a Type B medicated feed (b) The following definitions apply to from a Category II, Type A medicated terms used in this part: article requires a medicated feed mill (1) New animal drugs approved for license application approved under use in animal feed are placed in two § 515.20 of this chapter. categories as follows: (4) A ‘‘Type C medicated feed’’ is in- (i) Category I—These drugs require tended as the complete feed for the ani- no withdrawal period at the lowest use mal or may be fed ‘‘top dressed’’ (added level in each major species for which on top of usual ration) on or offered they are approved or are approved for ‘‘free-choice’’ (e.g., supplement) in con- use only in minor species. junction with other animal feed. It (ii) Category II—These drugs require contains a substantial quantity of nu- a withdrawal period at the lowest use trients including vitamins, minerals, level for at least one major species for and/or other nutritional ingredients. It which they are approved, or are regu- is manufactured by diluting a Type A lated on a ‘‘no-residue’’ basis or with a medicated article or a Type B medi- zero tolerance because of carcinogenic cated feed. A Type C medicated feed concern regardless of whether a with- may be further diluted to produce an- drawal period is required in any spe- other Type C medicated feed. The man- cies. ufacture of a Type C medicated feed (2) A ‘‘Type A medicated article’’ is from a Category II, Type A medicated intended solely for use in the manufac- article requires a medicated feed mill ture of another Type A medicated arti- license application approved under cle or a Type B or Type C medicated § 515.20 of this chapter. feed. It consists of a new animal (5) A Type B or Type C medicated drug(s), with or without carrier (e.g., feed manufactured from a drug compo- calcium carbonate, rice hull, corn, glu- nent (bulk or ‘‘drum-run’’ (dried crude ten) with or without inactive ingredi- fermentation product)) requires an ap- ents. The manufacture of a Type A plication approved under § 514.105 of medicated article requires an applica- this chapter or an index listing granted tion approved under § 514.105 of this under § 516.151 of this chapter. chapter or an index listing granted (6) A ‘‘veterinary feed directive under § 516.151 of this chapter. (VFD) drug’’ is a drug intended for use (3) A ‘‘Type B medicated feed’’ is in- in or on animal feed which is limited tended solely for the manufacture of by an approved application filed pursu- other medicated feeds (Type B or Type ant to section 512(b) of the Federal C). It contains a substantial quantity Food, Drug, and Cosmetic Act, a condi- of nutrients including vitamins and/or tionally approved application filed pur- minerals and/or other nutritional in- suant to section 571 of the Federal gredients in an amount not less than 25 Food, Drug, and Cosmetic Act, or an percent of the weight. It is manufac- index listing under section 572 of the tured by diluting a Type A medicated Federal Food, Drug, and Cosmetic Act article or another Type B medicated to use under the professional super- feed. The maximum concentration of vision of a licensed veterinarian. Use of

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animal feed bearing or containing a filed under section 512(b) of the Federal VFD drug must be authorized by a law- Food, Drug, and Cosmetic Act, a condi- ful veterinary feed directive. tionally approved application filed (7) A ‘‘veterinary feed directive’’ is a under section 571 of the Federal Food, written (nonverbal) statement issued Drug, and Cosmetic Act, or an index by a licensed veterinarian in the course listing under section 572 of the Federal of the veterinarian’s professional prac- Food, Drug, and Cosmetic Act to use tice that orders the use of a VFD drug under the professional supervision of a or combination VFD drug in or on an licensed veterinarian, and at least one animal feed. This written statement of the new animal drugs in the com- authorizes the client (the owner of the bination is a VFD drug. Use of animal animal or animals or other caretaker) feed bearing or containing a combina- to obtain and use animal feed bearing tion VFD drug must be authorized by a or containing a VFD drug or combination VFD drug to treat the client’s ani- lawful VFD. mals only in accordance with the con- (13) ‘‘Major species’’ means cattle, ditions for use approved, conditionally horses, swine, chickens, turkeys, dogs, approved, or indexed by the Food and and cats. Drug Administration. (14) ‘‘Minor species’’ means animals, (8) A ‘‘medicated feed’’ means a Type other than humans, that are not major B medicated feed as defined in para- species. graph (b)(3) of this section or a Type C [51 FR 7392, Mar. 3, 1986, as amended at 52 FR medicated feed as defined in paragraph 2682, Jan. 26, 1987; 54 FR 51386, Dec. 15, 1989; (b)(4) of this section. 56 FR 19268, Apr. 26, 1991; 64 FR 63206, Nov. 19, (9) For the purposes of this part, a 1999; 65 FR 76929, Dec. 8, 2000; 72 FR 69130, ‘‘distributor’’ means any person who Dec. 6, 2007; 80 FR 31733, June 3, 2015; 81 FR distributes a medicated feed containing 57800, Aug. 24, 2016] a VFD drug to another person. Such other person may be another dis- § 558.4 Requirement of a medicated tributor or the client-recipient of a feed mill license. VFD. (a) A feed manufacturing facility (10) An ‘‘animal production facility’’ must possess a medicated feed mill li- is a location where animals are raised cense in order to manufacture a Type B for any purpose, but does not include or Type C medicated feed from a Cat- the specific location where medicated egory II, Type A medicated article. feed is made. (11) An ‘‘acknowledgment letter’’ is a (b) The manufacture of the following written (nonverbal) communication types of feed are exempt from the re- provided to a distributor (consignor) quired license, unless otherwise speci- from another distributor (consignee). fied: An acknowledgment letter must be (1) Type B or Type C medicated feed provided either in hardcopy or through using Category I, Type A medicated ar- electronic media and must affirm: ticles or Category I, Type B or Type C (i) That the distributor will not ship medicated feeds; and such VFD feed to an animal production (2) Type B or Type C medicated feed facility that does not have a VFD, using Category II, Type B or Type C (ii) That the distributor will not ship medicated feeds. such VFD feed to another distributor (c) The use of Type B and Type C without receiving a similar written ac- medicated feeds shall also conform to knowledgment letter, and the conditions of use provided for in (iii) That the distributor has com- subpart B of this part. plied with the distributor notification (d) This paragraph identifies each requirements of § 558.6(c)(5). drug by category, the maximum level (12) A ‘‘combination veterinary feed of drug in Type B medicated feeds, and directive (VFD) drug’’ is a combination new animal drug (as defined in the assay limits for the drug in Type A § 514.4(c)(1)(i) of this chapter) intended medicated articles and Type B and for use in or on animal feed which is Type C medicated feeds, as follows: limited by an approved application

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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. Avilamycin ...... 90–110 7.3 g/lb (1.6%) ...... 80–110. Bacitracin methylenedisalicylate .. 85–115 25.0 g/lb (5.5%) ...... 70–130. Bacitracin zinc ...... 84–115 5.0 g/lb (1.1%) ...... 70–130. Bambermycins ...... 90–110 800 g/ton (0.09%) ...... 80–120/70–130. Chlortetracycline ...... 85–115 40.0 g/lb (8.8%) ...... 80–115/70–130. Coumaphos ...... 95–115 6.0 g/lb (1.3%) ...... 80–120. Decoquinate ...... 90–105 2.72 g/lb (0.6%) ...... 80–120. Dichlorvos ...... 100–115 33.0 g/lb (7.3%) ...... 90–120/80–130. Diclazuril ...... 90–110 182 g/t (0.02%) ...... 85–115/70–120. Efrotomycin ...... 94–113 1.45 g/lb (0.32%) ...... 80–120. Iodinated casein ...... 85–115 20.0 g/lb (4.4%) ...... 75–125. Laidlomycin propionate potassium 90–110 1 g/lb (0.22%) ...... 90–115/85–115. Lasalocid ...... 95–115 40.0 g/lb (8.8%) ...... Type B (cattle and sheep): 80–120; Type C (all): 75–125. Lincomycin ...... 90–115 20.0 g/lb (4.4%) ...... 80–130. Lubabegron ...... 87–107 908 g/ton...... 85–115/80–120. 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 9.0 g/lb (1.98%) ...... 85–115/75–125. Nicarbazin (granular) ...... 90–110 9.0 g/lb (1.98%) ...... 85–115/75–125. Narasin ...... 90–110 9.0 g/lb (1.98%) ...... 85–115/75–125. Nystatin ...... 85–125 5.0 g/lb (1.1%) ...... 75–125. Oxytetracycline ...... 90–120 20.0 g/lb (4.4%) ...... 75–125/65–135. Poloxalene ...... 90–110 54.48 g/lb (12.0%) ...... Liq. feed: 85–115. Ractopamine ...... 85–105 2.46 g/lb (0.54%) ...... 80–110/75–125. Salinomycin ...... 90–110 6.0 g/lb (1.3%) ...... 80–120. Semduramicin (as semduramicin 90–110 2.27 g/lb (0.50%) ...... 80–110 sodium). Semduramicin (as semduramicin 90–110 2.27 g/lb (0.50%) ...... 80–120 sodium biomass). Tylosin ...... 80–120 10.0 g/lb (2.2%) ...... 75–125. Tylvalosin ...... 90–110 3.86 g/lb...... 85–115. Virginiamycin ...... 85–115 10.0 g/lb (2.2%) ...... 70–130. Zoalene ...... 92–104 11.35 g/lb (2.5%) ...... 85–115. 1 Percent of labeled amount. 2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make Type C medicated feed.

CATEGORY II

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

Amprolium ...... 94–114 11.35 g/lb (2.5%) ...... 80–120. Apramycin ...... 88–112 7.5 g/lb (1.65%) ...... 80–120. Carbadox ...... 90–110 2.5 g/lb (0.55%) ...... 75–125. Clopidol ...... 94–106 11.4 g/lb (2.5%) ...... 90–115/80–120. Erythromycin ...... 85–115 4.625 g/lb (1.02%) ...... 75–125. Famphur ...... 100–110 5.5 g/lb (1.21%) ...... 90–115/80–120. Fenbendazole ...... 93–113 8.87 g/lb (1.96%) ...... 75–125. Florfenicol ...... 90–110 9.1 g/lb (2.0%) ...... Swine feed: 85–115 Catfish feed: 80–110. Salmonid feed: 80–110. Halofuginone hydrobromide ...... 90–115 272.0 g/ton (.03%) ...... 75–125. Hygromycin B ...... 90–110 1,200 g/ton (0.13%) ...... 75–125. Ivermectin ...... 95–105 1,180 g/ton (0.13%) ...... 80–110. Maduramicin ammonium ...... 90–110 545 g/ton (.06%) ...... 80–120. Morantel tartrate ...... 90–110 66.0 g/lb (14.52%) ...... 85–115. Neomycin ...... 80–120 20 g/lb (4.4%) ...... 70–125. Oxytetracycline ...... 80–120 20 g/lb (4.4%) ...... 65–135. Neomycin sulfate ...... 80–120 100 g/lb (22.0%) ...... 70–125. Nicarbazin (granular) ...... 90–110 5.675 g/lb (1.25%) ...... 85–115/75–125. Nicarbazin (powder) ...... 96–104 9.08 g/lb (2.00%) ...... 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

Novobiocin ...... 85–115 17.5 g/lb (3.85%) ...... 80–120. Pyrantel tartrate ...... 90–110 36 g/lb (7.9%) ...... 75–125. Robenidine ...... 95–115 1.5 g/lb (0.33%) ...... 80–120. Sulfadimethoxine ...... 90–110 Poultry: 5.675 g/lb ...... 80–115/75–125. Fish: 85.1 g/lb ...... Ormetoprim ...... 90–110 Poultry: 3.405 g/lb ...... 80–115. Fish: 17.0 g/lb ...... Sulfamerazine ...... 85–115 18.6 g/lb (4.0%) ...... 85–115. Sulfamethazine ...... 85–115 10.0 g/lb (2.2%) ...... 80–120. Chlortetracycline ...... 85–115 10.0 g/lb (2.2%) ...... 85–125/70–130. Sulfamethazine ...... 85–115 10.0 g/lb (2.2%) ...... 80–120. Tylosin ...... 80–120 10.0 g/lb (2.2%) ...... 75–125. Sulfaquinoxaline ...... 98–106 11.2 g/lb (2.5%) ...... 85–115. Thiabendazole ...... 94–106 45.4 g/lb (10.0%) ...... >7% 85–115; <7% 90–110. Tiamulin hydrogen fumarate ...... 90–115 10 g/lb ...... 90–115/70–130. Tilmicosin ...... 90–110 37.9 g/lb (8.35%) ...... Swine Type B/C feed: 85–115. Cattle Type B feed: 85–115. Cattle Type C feed: 80–110. 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 liquid feed must be approved for such are in combination, the Category II re- use under section 512 of the Federal quirements will apply to the combina- Food, Drug, and Cosmetic Act (the act) tion drug product. or index listed under section 572 of the act. Such approvals under section 512 [51 FR 7392, Mar. 3, 1986] of the act must be: EDITORIAL NOTE: For FEDERAL REGISTER ci- (1) An original NADA, tations affecting § 558.4, see the List of CFR (2) A supplemental NADA, or Sections Affected, which appears in the (3) An abbreviated NADA. Finding Aids section of the printed volume (d) What are the approval requirements and at www.govinfo.gov. under section 512 of the act for new ani- § 558.5 Requirements for liquid medi- mal drugs intended for use in liquid feed? cated feed. An approval under section 512 of the act for a new animal drug intended for (a) What types of liquid medicated feeds use in liquid feed must contain the fol- are covered by this section? This section lowing information: covers the following types of liquid (1) Data, or a reference to data in a medicated feed: master file (MF), that shows the rel- (1) Type B feed that is intended for evant ranges of conditions under which further manufacture of other medi- the drug will be chemically stable in cated feeds (§ 558.3(b)(3)) or: liquid feed under field use conditions; (2) Type C feed that is intended for and the following: (2) Data, or a reference to data in an (i) Further manufacture of another MF, that shows that the drug is phys- Type C feed, or ically stable in liquid feed under field (ii) Top-dressing (adding on top of the conditions; or usual ration) (§ 558.3(b)(4)). (3) Feed labeling with recirculation (b) How is liquid free-choice medicated or agitation directions as follows: feed regulated? Liquid free-choice medi- (i) For liquid feeds stored in recircu- cated feed is covered by this section lating tank systems: Recirculate im- and by § 510.455. mediately prior to use for not less than (c) What is required for new animal 10 minutes, moving not less than 1 per- drugs intended for use in liquid feed? Any cent of the tank contents per minute new animal drug intended for use in from the bottom of the tank to the top.

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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. [69 FR 30197, May 27, 2004, as amended at 71 (g) When is a medicated feed mill license FR 74785, Dec. 13, 2006; 72 FR 69131, Dec. 6, required for the manufacture of a liquid 2007] medicated feed? An approved medicated feed mill license is required for the § 558.6 Veterinary feed directive manufacture of the following types of drugs. feeds: (a) General requirements related to vet- (1) All liquid medicated feeds that erinary feed directive (VFD) drugs. (1) contain a Category II drug, and Animal feed bearing or containing a (2) Liquid medicated feeds that con- VFD drug or a combination VFD drug tain a Category I drug and use a propri- (a VFD feed or combination VFD feed) etary formula and/or specifications. may be fed to animals only by or upon (h) What measures are in place to pre- a lawful VFD issued by a licensed vet- vent certain drugs, approved for use in erinarian. animal feed or drinking water but not in (2) A VFD feed or combination VFD liquid medicated feed, from being diverted feed must not be fed to animals after to use in liquid feeds? Any product con- the expiration date on the VFD. taining any form of bacitracin, oxytet- (3) Use and labeling of a VFD drug or racycline, or chlortetracycline, in- a combination VFD drug in feed is lim- tended for oral administration via ani- ited to the approved, conditionally ap- mal feed and/or drinking water, and proved, or indexed conditions of use. not approved for use in a liquid medi- Use of feed containing this veterinary cated feed must include in its labeling feed directive (VFD) drug in a manner the following statement: ‘‘FOR USE IN other than as directed on the labeling lll ONLY. NOT FOR USE IN LIQ- (extralabel use) is not permitted. UID MEDICATED FEEDS.’’ The blank (4) All involved parties (the veteri- may be filled in with the words: ‘‘DRY narian, the distributor, and the client) FEEDS’’, ‘‘DRINKING WATER’’, or must retain a copy of the VFD for 2

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years. The veterinarian must retain listing, if such date is specified. In the original VFD in its original form cases where the expiration date is not (electronic or hardcopy). The dis- specified in the approval, conditional tributor and client copies may be kept approval, or index listing, the expira- as an electronic copy or hardcopy. tion date of the VFD must not exceed (5) All involved parties must make 6 months after the date of issuance; the VFD and any other records speci- (vi) The name of the VFD drug(s); fied in this section available for inspec- (vii) The species and production class tion and copying by FDA upon request. of animals to be fed the VFD feed; (6) All labeling and advertising for (viii) The approximate number of VFD drugs, combination VFD drugs, animals to be fed the VFD feed by the and feeds containing VFD drugs or expiration date of the VFD. The ap- combination VFD drugs must promi- proximate number of animals is the po- nently and conspicuously display the tential number of animals of the spe- following cautionary statement: ‘‘Cau- cies and production class identified on tion: Federal law restricts medicated the VFD that will be fed the VFD feed feed containing this veterinary feed di- or combination VFD feed at the speci- rective (VFD) drug to use by or on the fied premises by the expiration date of order of a licensed veterinarian.’’ the VFD; (b) Responsibilities of the veterinarian (ix) The indication for which the issuing the VFD. (1) In order for a VFD VFD is issued; to be lawful, the veterinarian issuing (x) The level of VFD drug in the VFD the VFD must: feed and duration of use; (i) Be licensed to practice veterinary (xi) The withdrawal time, special in- medicine; and structions, and cautionary statements (ii) Be operating in the course of the necessary for use of the drug in con- veterinarian’s professional practice formance with the approval; and in compliance with all applicable (xii) The number of reorders (refills) veterinary licensing and practice re- authorized, if permitted by the drug quirements, including issuing the VFD approval, conditional approval, or in the context of a veterinarian-client- index listing. In cases where reorders patient relationship (VCPR) as defined (refills) are not specified on the label- by the State. If applicable VCPR re- ing for an approved, conditionally ap- quirements as defined by such State do proved, or index listed VFD drug, reor- not include the key elements of a valid ders (refills) are not permitted; VCPR as defined in § 530.3(i) of this (xiii) The statement: ‘‘Use of feed chapter, the veterinarian must issue containing this veterinary feed direc- the VFD in the context of a valid tive (VFD) drug in a manner other VCPR as defined in § 530.3(i) of this than as directed on the labeling chapter. (extralabel use) is not permitted.’’; (2) The veterinarian must only issue (xiv) An affirmation of intent for a VFD that is in compliance with the combination VFD drugs as described in conditions for use approved, condi- paragraph (6) of this section; and tionally approved, or indexed for the (xv) The veterinarian’s electronic or VFD drug or combination VFD drug. written signature. (3) The veterinarian must ensure that (4) The veterinarian may, at his or the following information is fully and her discretion, enter the following in- accurately included on the VFD: formation on the VFD to more specifi- (i) The veterinarian’s name, address, cally identify the animals authorized and telephone number; to be treated/fed the VFD feed: (ii) The client’s name, business or (i) A more specific description of the home address, and telephone number; location of animals (e.g., by site, pen, (iii) The premises at which the ani- barn, stall, tank, or other descriptor mals specified in the VFD are located; that the veterinarian deems appro- (iv) The date of VFD issuance; priate); (v) The expiration date of the VFD. (ii) The approximate age range of the This date must not extend beyond the animals; expiration date specified in the ap- (iii) The approximate weight range of proval, conditional approval, or index the animals; and

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(iv) Any other information the vet- VFD only if the VFD contains all the erinarian deems appropriate to identify information required in paragraph the animals specified in the VFD. (b)(3) of this section. (5) For VFDs intended to authorize (2) The distributor is permitted to the use of an approved, conditionally distribute an animal feed containing a approved, or indexed combination VFD VFD drug or combination VFD drug drug that includes more than one VFD only if it complies with the terms of drug, the veterinarian must include the the VFD and is manufactured and la- drug-specific information required in beled in conformity with the approved, paragraphs (b)(3)(vi), (ix), (x), and (xi) conditionally approved, or indexed con- of this section for each VFD drug in ditions of use for such drug. the combination. (3) The distributor must keep records (6) The veterinarian may restrict of the receipt and distribution of all VFD authorization to only include the medicated animal feed containing a VFD drug(s) cited on the VFD or may VFD drug for 2 years. expand such authorization to allow the (4) In addition to other applicable use of the cited VFD drug(s) along with recordkeeping requirements found in one or more over-the-counter (OTC) this section, if the distributor manu- animal drugs in an approved, condi- factures the animal feed bearing or tionally approved, or indexed combina- containing the VFD drug, the dis- tion VFD drug. The veterinarian must tributor must also keep VFD feed man- affirm his or her intent regarding com- ufacturing records for 1 year in accord- bination VFD drugs by including one of ance with part 225 of this chapter. Such the following statements on the VFD: records must be made available for in- (i) ‘‘This VFD only authorizes the use spection and copying by FDA upon re- of the VFD drug(s) cited in this order quest. and is not intended to authorize the (5) A distributor of animal feed con- use of such drug(s) in combination with taining a VFD drug must notify FDA any other animal drugs.’’ prior to the first time it distributes (ii) ‘‘This VFD authorizes the use of animal feed containing a VFD drug. the VFD drug(s) cited in this order in The notification is required one time the following FDA-approved, condi- per distributor and must include the tionally approved, or indexed combina- following information: tion(s) in medicated feed that contains (i) The distributor’s complete name the VFD drug(s) as a component.’’ [List and business address; specific approved, conditionally ap- (ii) The distributor’s signature or the proved, or indexed combination medi- signature of the distributor’s author- cated feeds following this statement.] ized agent; and (iii) ‘‘This VFD authorizes the use of (iii) The date the notification was the VFD drug(s) cited in this order in signed. any FDA-approved, conditionally ap- (6) A distributor must also notify proved, or indexed combination(s) in FDA within 30 days of any change in medicated feed that contains the VFD ownership, business name, or business drug(s) as a component.’’ address. (7) The veterinarian must issue a (7) The notifications cited in para- written (nonverbal) VFD. graphs (c)(5) and (c)(6) of this section (8) The veterinarian must send a copy must be submitted to the Food and of the VFD to the distributor via Drug Administration, Center for Vet- hardcopy, facsimile (fax), or electroni- erinary Medicine, Division of Animal cally. If in hardcopy, the veterinarian Feeds (HFV–220), 7519 Standish Pl., must send the copy of the VFD to the Rockville, MD 20855, FAX: 240–453–6882. distributor either directly or through (8) A distributor is permitted to dis- the client. tribute a VFD feed to another dis- (9) The veterinarian must provide a tributor only if the originating dis- copy of the VFD to the client. tributor (consignor) first obtains a (c) Responsibilities of any person who written (nonverbal) acknowledgment distributes an animal feed containing a letter, as defined in § 558.3(b)(11), from VFD drug or a combination VFD drug. (1) the receiving distributor (consignee) The distributor is permitted to fill a before the feed is shipped. Consignor

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distributors must retain a copy of each § 510.600(c) of this chapter for use as in consignee distributor’s acknowledg- paragraph (d) of this section. ment letter for 2 years. (b) Special considerations. Do not use [80 FR 31733, June 3, 2015; 80 FR 35841, June in Type B or Type C medicated feeds 23, 2015] containing bentonite. (c) Related tolerances. See § 556.50 of Subpart B—Specific New Animal this chapter. Drugs for Use in Animal Feeds (d) Conditions of use—(1) Cattle. It is used as follows: § 558.55 Amprolium. (a) Approvals. Type A medicated articles: 25 percent to No. 016592 in

Amprolium in grams per ton Indications for use Limitations Sponsor

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

(2) Chickens. It is used as follows:

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

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

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

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

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

(ii) 36.3 to 113.5 ..... Bacitracin Replacement chickens: For devel- Feed according to subtable in 054771 methylenedisalicy- opment of active immunity to item (i). Bacitracin late 4 to 50. coccidiosis; and for increased methylenedisalicylate as pro- rate of weight gain and im- vided by No. 054771 in proved feed efficiency. § 510.600(c) of this chapter. (iii) 72.6 to 113.5 ...... Broiler chickens: For prevention Feed continuously as the sole ra- 016592 of coccidiosis caused by tion; as sole source of Eimeria tenella only. amprolium.

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

(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. (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]

(5) Permitted combinations. Amprolium § 558.58 Amprolium and ethopabate. may also be used in combination with: (a) Specifications. Type A medicated (i) Virginiamycin as in § 558.635. articles containing: (ii) [Reserved] (1) 25 percent amprolium and 8 per- [41 FR 10985, Mar. 15, 1976] cent ethopabate or 5 percent amprolium and 1.6 percent ethopabate; EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 558.55, see the List of CFR (2) 25 percent amprolium and 0.8 per- Sections Affected, which appears in the cent ethopabate or 5 percent Finding Aids section of the printed volume amprolium and 0.16 percent and at www.govinfo.gov. ethopabate.

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(b) Approvals. See No. 016592 in (d) Related tolerances. See §§ 556.50 and § 510.600(c) of this chapter. 556.260 of this chapter. (c) Special considerations. Do not use (e) Conditions of use. It is used in in Type B or Type C medicated feeds chicken feed as follows: containing bentonite.

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

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

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

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

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

[81 FR 94995, Dec. 27, 2016] this veterinary feed directive (VFD) drug to use by or on the order of a li- § 558.68 Avilamycin. censed veterinarian. See § 558.6 for addi- (a) Each pound of Type A medicated tional requirements. article contains 45.4 or 90.7 grams of (2) The expiration date of VFDs for avilamycin. avilamycin medicated feeds must not (b) Sponsor. See No. 058198 in exceed 90 days from the date of § 510.600(c) of this chapter. issuance. VFDs for avilamycin shall (c) Related tolerances. See § 556.60 of not be refilled. this chapter. (e) Conditions of use. Administer in (d) Special considerations. (1) Federal feed as follows: law restricts medicated feed containing (1) Chickens—

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

(i) 13.6 to 40.9 ...... Broiler chickens: For the preven- Feed as the sole ration for 21 con- 058198 tion of mortality caused by ne- secutive days. To assure re- crotic enteritis associated with sponsible antimicrobial drug use Clostridium perfringens in broiler in broiler chickens, treatment ad- chickens. ministration must begin on or before 18 days of age. (ii) 13.6 to 40.9 ...... Monensin, 90 to 110 ...... Feed as the sole ration for 21 con- 058198 secutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens in broiler chickens. Avilamycin has not been demonstrated to be effective in broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. Do not feed to chickens over 16 weeks of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Do not allow horses or other equines access to feed containing avilamycin and monensin. Inges- tion of monensin by horses has been fatal. Do not feed to chickens producing eggs for human consumption. Monensin as provided by No. 058198 in § 510.600(c) of this chapter.

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

(iii) 13.6 to 40.9 ...... Narasin, 54 to 90 ...... Feed as the sole ration for 21 con- 058198 secutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens. Avilamycin has not been demonstrated to be effective in broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Do not feed to chickens producing eggs for human consumption. Narasin as provided by No. 058198 in § 510.600(c) of this chapter. (iv) 13.6 to 40.9 .... Narasin 27 to Broiler chickens: For the preven- Feed as the sole ration for 21 con- 058198 45; nicarbazin tion of mortality caused by ne- secutive days to chickens that 27 to 45 crotic enteritis associated with are at risk of developing, but not Clostridium perfringens; and for yet showing clinical signs of, ne- the prevention of coccidiosis crotic enteritis associated with caused by Eimeria necatrix, E. Clostridium perfringens. To as- tenella, E. acervulina, E. sure responsible antimicrobial brunetti, E. mivati, and E. maxi- drug use in broiler chickens, ma. treatment administration must begin on or before 10 days of age. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Inges- tion of narasin by these species has been fatal. Do not feed to laying hens. Withdraw 5 days before slaughter. Narasin and nicarbazin as provided by No. 058198 in § 510.600(c) of this chapter.

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

(v) 13.6 to 40.9 ...... Salinomycin sodium, 40 to 60 ...... Feed as the sole ration for 21 con- 058198 secutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens. Avilamycin has not been demonstrated to be effective in broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. May be fatal if fed to adult turkeys or to horses. Not approved for use with pellet binders. Do not feed to laying hens producing eggs for human consumption. Salinomycin as provided by No. 016592 in § 510.600(c) of this chapter.

(2) Swine—

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

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

[80 FR 61297, Oct. 13, 2015, as amended at 80 paragraphs (e)(1)(i), (e)(1)(iii), (e)(1)(v) FR 76387, Dec. 9, 2015; 81 FR 17609, Mar. 30, through (xiii), and (e)(1)(xv) of this sec- 2016; 81 FR 48703, July 26, 2016; 81 FR 59134, tion. Aug. 29, 2016; 81 FR 67152, Sept. 30, 2016; 82 FR 11509, Feb. 24, 2017; 83 FR 14587, Apr. 5, 2018; (2) No. 069254 for use of products in 83 FR 64741, Dec. 18, 2018; 84 FR 8974, Mar. 13, paragraph (a)(2) of this section as in 2019; 84 FR 33001, July 11, 2019; 85 FR 4209, paragraphs (e)(1)(ii), (e)(1)(iv), Jan. 24, 2020] (e)(1)(xiv), and (e)(1)(xvi) of this section. § 558.76 Bacitracin (c) Special considerations. The quan- methylenedisalicylate. tities of antibiotics are expressed in (a) Specifications. (1) Type A medi- terms of the equivalent amount of an- cated articles containing 10, 25, 30, 40, tibiotic standard. 50, 60, or 75 grams bacitracin (d) Related tolerances. See § 556.70 of methylenedisalicylate per pound. this chapter. (2) Type A medicated article con- (e) Conditions of use. (1) It is used as taining 50 grams bacitracin follows: methylenedisalicylate per pound. (b) Sponsors. See sponsors in § 510.600(c) of this chapter: (1) No. 054771 for use of products in paragraph (a)(1) of this section as in

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

(i) 4 to 50 g/ton ...... Chickens, turkeys, and pheas- ...... 054771 ants: For increased rate of weight gain and improved feed efficiency. (ii) 4 to 50 g/ton ...... Broiler and replacement chick- ...... 069254 ens, growing turkeys, and growing pheasants: For increased rate of weight gain and improved feed efficiency. (iii) 5 to 20 g/ton ...... Quail not over 5 weeks of age: ...... 054771 For increased rate of weight gain and improved feed efficiency. (iv) 5 to 20 g/ton ...... Growing quail: For increased For use in quail not over 5 069254 rate of weight gain and im- weeks of age. proved feed efficiency. (v) 10 to 25 g/ton ...... Chickens: For increased egg For first 7 months of production 054771 production and improved feed efficiency for egg production. (vi) 10 to 30 g/ton ...... Swine: For increased rate of For growing and finishing swine 054771 weight gain and improved feed efficiency. (vii) 50 g/ton ...... Broiler chickens: As an aid in Feed continuously as sole ration 054771 the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Replacement chickens: As an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. (viii) 100 to 200 g/ton ...... Broiler chickens: As an aid in Feed continuously as sole ra- 054771 the control of necrotic enteritis tion. Start at first clinical signs caused or complicated by of disease, vary dosage based Clostridium spp. or other orga- on severity of infection, admin- nisms susceptible to baci- ister continuously for 5 to 7 tracin. Replacement chickens: days or as long as clinical As an aid in the control of ne- signs persist, then reduce crotic enteritis caused or com- medication to prevention level plicated by Clostridium spp. or (50 g/ton). other organisms susceptible to bacitracin. (ix) 200 g/ton ...... Turkeys: As an aid in the control Feed continuously as the sole 054771 of transmissible enteritis in ration. growing turkeys complicated by organisms susceptible to bacitracin methylenedisalicylate. Quail: For the prevention of ulcerative enteritis in growing quail due to Clostridium colinum susceptible to bacitracin methylenedisalicylate. (x) 250 g/ton ...... 1. Growing/finishing swine: For As the sole ration. Not for use in 054771 control of swine dysentery swine weighing more than 250 Treponema hyodysenteriae on pounds. Diagnosis should be premises with history of swine confirmed by a veterinarian a dysentery but where signs of when results are not satisfac- the disease have not yet oc- tory. curred; or following an approved treatment of the disease condition. 2. Pregnant sows: For control of As the sole ration. Feed to sows clostridial enteritis caused by from 14 days before through C. perfringens in suckling pig- 21 days after farrowing on lets. premises with a history of clostridial scours. Diagnosis should be confirmed by veterinarian when results are not satisfactory.

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

(xi) To provide 70 mg ...... Feedlot beef cattle: For reduc- Administer continuously through- 054771 per head per day. tion in the number of liver con- out the feeding period. demnations due to abscesses. (xii) To provide 70 mg ...... Beef steers and heifers fed in Administer continuously through- 069254 per head per day. confinement for slaughter: For out the feeding period. reduction in the number of liver condemnations due to abscesses. (xiii) To provide 250 ...... Feedlot beef cattle: For reduc- Administer continuously for 5 054771 mg per head per tion in the number of liver con- days then discontinue for sub- day. demnations due to abscesses. sequent 25 days, repeat the pattern during the feeding period. (xiv) To provide 250 ...... Beef steers and heifers fed in Administer continuously for 5 069254 mg per head per confinement for slaughter: For days then discontinue for sub- day. reduction in the number of sequent 25 days, repeat the liver condemnations due to pattern during the feeding pe- abscesses. riod.

(2) Bacitracin methylenedisalicylate EDITORIAL NOTES 1. For FEDERAL REGISTER may also be used in combination with: citations affecting § 558.76, see the List of (i) Amprolium as in § 558.55. CFR Sections Affected, which appears in the (ii) Amprolium and ethopabate as in Finding Aids section of the printed volume § 558.58. and at www.govinfo.gov. (iii) Chlortetracycline as in § 558.128. 2. At 80 FR 78970, Dec. 18, 2015, § 558.76 was (iv) Clopidol as in § 558.175. amended by removing and reserving para- (v) Decoquinate as in § 558.195. graph (d)(3)(xiii); however, the amendment (vi) Diclazuril as in § 558.198. could not be incorporated because the para- (vii) Fenbendazole as in § 558.258. graph did not exist. (viii) Halofuginone as in § 558.265. (ix) Ivermectin as in § 558.300. § 558.78 Bacitracin zinc. (x) Lasalocid as in § 558.311. (a) Specifications. Type A medicated (xi) Monensin as in § 558.355. articles containing bacitracin zinc (xii) Narasin as in § 558.363. equivalent to 10, 25, 40, or 50 grams per (xiii) Narasin and nicarbazin as in pound bacitracin. § 558.364. (b) Approvals. See No. 054771 in (xiv) Nicarbazin as in § 558.366. § 510.600(c) of this chapter. (xv) Robenidine as in § 558.515. (xvi) Salinomycin as in § 558.550. (c) Related tolerances. See § 556.70 of (xvii) Semduramicin as in § 558.555. this chapter. (xviii) Zoalene as in § 558.680. (d) Conditions of use. (1) It is used as follows: [41 FR 10993, Mar. 15, 1976]

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

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

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

(vii) 20 to 40 ...... Growing-finishing swine; im- ...... do ...... 054771 proved feed efficiency.

(2) It is used in feed for growing cat- § 558.95 Bambermycins. tle at 35 to 70 milligrams per head per (a) Approvals. See sponsors in day as follows: § 510.600(c) of this chapter for use of (i) To aid in stimulating growth and Type A medicated articles as in para- improving feed efficiency. graph (d) of this section: (ii) For increased rate of weight gain (1) No. 016592: 2, 4, and 10 grams per and improved feed efficiency; see spon- pound for use as in paragraphs (d)(1), sor 054771. (d)(2), (d)(3), and (d)(4) of this section. (3) Bacitracin zinc may also be used (2) No. 012286: 2 grams for use as in in combination with: paragraph (d)(2) of this section and 0.4 (i) Amprolium and ethopabate as in and 2 grams per pound for use as in § 558.58. paragraph (d)(3). (ii) Clopidol as in § 558.175. (b) Special considerations. (1) Bambermycins liquid Type B feeds may (iii) Decoquinate as in § 558.195. be manufactured from dry (iv) Lasalocid as in § 558.311. bambermycins Type A articles. The (v) Monensin as in § 558.355. liquid Type B feeds must have a pH of (vi) Naracin as in § 558.363. 3.8 to 7.5, moisture content of 30 to 45 (vii) Nicarbazin as in § 558.366. percent. (viii) Robenidine as in § 558.515. (2) The expiration date for the liquid (ix) Salinomycin as in § 558.550. Type B feed is 8 weeks after date of manufacture. The expiration date for [41 FR 10994, Mar. 15, 1976] the dry Type C feed made from the liq- EDITORIAL NOTE: For FEDERAL REGISTER ci- uid Type B feed is 1 week after date of tations affecting § 558.78, see the List of CFR manufacture. Sections Affected, which appears in the (c) Related tolerances. See § 556.75 of Finding Aids section of the printed volume this chapter. and at www.govinfo.gov. (d) Conditions of use—(1) Chickens. Use in medicated feed as follows:

Bambermycins in grams/ton Indications for use Limitations Sponsor

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

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

Bambermycins in grams/ton Indications for use Limitations Sponsor

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

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

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Bambermycins in grams/ton Indications for use Limitations Sponsor

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

(4) Cattle.

Bambermycins in grams/ton Indications for use Limitations Sponsor

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

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

Ingredient International Feed No. Percent

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

(b) Amount per ton. 120 grams. (iv) Use free-choice Type C medicated (c)Indications for use. For increased feeds for pasture cattle (slaughter, rate of weight gain. stocker, and feeder cattle; and beef re- (d) Limitations. For free-choice feed- placement heifers) as follows: ing to pasture cattle (slaughter, stock- (a) Amount. Feed continuously to pro- er, and feeder cattle; and beef replace- vide 10 to 40 milligrams of ment heifers). Feed a nonmedicated bambermycins per head per day. commercial mineral product for 6 (b) Indications for use. For increased weeks to stabilize consumption be- rate of weight gain. tween 2.66 and 10.66 ounces per head per (c) Limitations. Each use in a free- day. Feed continuously to provide 10 to choice Type C medicated feed must be 40 milligrams bambermycins per head the subject of an approved new animal per day. Daily bambermycins intakes drug application (NADA) or supple- in excess of 20 mg/head/day have not mental NADA as required by 21 CFR been shown to be more effective than 20 510.455. Daily bambermycins intakes in mg/head/day. excess of 20 mg/head/day have not been

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shown to be more effective than 20 mg/ ture cattle (slaughter, stocker, and head/day. feeder cattle; and dairy and beef re- (v) Used as a free-choice Type C placement heifers) as follows: medicated loose mineral feed for pas- (A) Specifications.

Ingredient International Feed No. Percent

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

(B) Amount per ton. 120 grams. § 558.115 Carbadox. (C) Indications for use. For increased (a) Approvals. Type A medicated arti- rate of weight gain. cles: 2.2. percent (10 grams per pound) (D) Limitations. For free-choice feed- to 066104 in § 510.600(c) of this chapter. ing to pasture cattle (slaughter, stocker, and feeder cattle; and dairy and beef (b) Related tolerances. See § 556.100 of replacement heifers). Feed a non-medi- this chapter. cated commercial mineral product for 6 (c) Special considerations. Do not use weeks to stabilize consumption be- in Type B or Type C medicated feeds tween 2.66 and 10.66 ounces per head per containing bentonite. day. Feed continuously to provide 10 to (d) Conditions of use. It is used for 40 milligrams bambermycins per head swine as follows: per day. Daily bambermycins intakes (1) Amount per ton. 10–25 grams in excess of 20 mg/head/day have not (0.0011–0.00275 percent). been shown to be more effective than 20 (i) Indications for use. For increase in mg/head/day. rate of weight gain and improvement of (5) Bambermycins may also be used feed efficiency. in combination with: (ii) Limitations. Not for use in preg- (i) Amprolium as in § 558.55. nant swine or swine intended for breed- (ii) Amprolium and ethopabate as in ing purposes. Do not feed to swine § 558.58. within 42 days of slaughter. (iii) Clopidal as in § 558.175. (2) Amount per ton. 50 grams (0.0055 (iv) Diclazuril as in § 558.198. percent). (v) Halofuginone as in § 558.265. (i) Indications for use. For control of (vi) Lasalocid as in § 558.311. swine dysentery (vibrionic dysentery, (vii) Monensin as in § 558.355. bloody scours, or hemorrhagic dys- (viii) Narasin as in § 558.363. entery); control of bacterial swine en- (ix) Narasin and nicarbazin as in teritis (salmonellosis or necrotic enter- § 558.364. itis caused by Salmonella choleraesuis); (x) Nicarbazin as in § 558.366. increased rate of weight gain and im- (xi) Salinomycin as in § 558.550. proved feed efficiency. (xii) Zoalene as in § 558.680. (ii) Limitations. Not for use in preg- [40 FR 13959, Mar. 27, 1975] nant swine or swine intended for breeding purposes. Do not feed to swine EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 558.95, see the List of CFR within 42 days of slaughter. Sections Affected, which appears in the (3) Amount per ton. Carbadox 50 grams Finding Aids section of the printed volume (0.0055 percent) plus pyrantel tartrate, and at www.govinfo.gov. 96 grams (0.0106 percent).

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(i) Indications for use. For control of (1) No. 054771: 50, 70, 80, 90, or 100 swine dysentery (vibrionic dysentery, grams per pound (g/lb) Type A medi- bloody scours, or hemorrhagic dys- cated article. entery); control of bacterial swine en- (2) No. 066104: 10, 20, 30, 50, 70, or 100 teritis (salmonellosis or necrotic enter- g/lb of Type A medicated article. itis caused by Salmonella choleraesuis); (3) No. 069254: 50, 90, or 100 g/lb of aid in the prevention of migration and Type A medicated article. establishment of large roundworm (c) Related tolerances. See § 556.150 of (Ascaris suum) infections; aid in the this chapter. prevention of establishment of nodular (d) Special considerations. (1) Federal worm (Oesophagostomum) infections. law restricts medicated feed containing (ii) Limitations. Do not feed to swine this veterinary feed directive (VFD) over 75 pounds; do not feed within 10 drug to use by or on the order of a li- weeks of slaughter; consult a veteri- censed veterinarian. See § 558.6 for addi- narian before feeding to severely de- tional requirements. bilitated animals; feed continuously as (2) The expiration date of VFDs for sole ration. Do not use in complete chlortetracycline medicated feeds must feeds containing less than 15 percent not exceed 6 months from the date of crude protein. issuance. VFDs for chlortetracycline shall not be refilled. (4) Carbadox may also be used in (3) In milk replacers or starter feed; combination with oxytetracycline as in include on labeling the warning: ‘‘A § 558.450. withdrawal period has not been estab- [40 FR 13959, Mar. 27, 1975, as amended at 40 lished for this product in FR 45164, Oct. 1, 1975; 40 FR 57798, Dec. 12, preruminating calves. Do not use in 1975; 42 FR 761, Jan. 4, 1977; 51 FR 7396, Mar. calves to be processed for veal.’’ 3, 1986; 63 FR 59216, Nov. 3, 1998; 66 FR 47963, (4) Manufacture for use in free-choice Sept. 17, 2001; 69 FR 51173, Aug. 18, 2004; 82 FR feeds as in paragraph (e)(4)(iii) of this 21691, May 10, 2017] section must conform to § 510.455 of this chapter. § 558.128 Chlortetracycline. (5) When manufactured for use as in (a) Specifications. Type A medicated paragraph (e)(5)(iii) of this section, in- articles containing either chlortetra- clude on labeling the warning: ‘‘Psit- cycline calcium complex equivalent to tacosis, avian chlamydiosis, or orni- chlortetracycline hydrochloride, or for thosis is a reportable communicable products intended for use in milk re- disease, transmissible between wild and placer, chlortetracycline hydro- domestic birds, other animals, and chloride. man. Contact appropriate public health (b) Approvals. See sponsors in and regulatory officials.’’ § 510.600(c) of this chapter for use as in (e) Conditions of use—(1) Chickens. It paragraph (e) of this section. is used as follows:

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

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

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

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

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

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

(2) Turkeys. It is used as follows:

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

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

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

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

(3) Swine. It is used as follows:

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

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

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

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

(4) Cattle. It is used as follows:

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

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

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

2. Calves (up to 250 lb): For See paragraph (d)(3) of this 054771 the treatment of bacterial section. 066104 enteritis caused by E. coli 069254 susceptible to chlortetracycline. (v) 10 mg/lb of body weight Laidlomycin, 5 ...... Cattle fed in confinement for Feed continuously at a rate of 054771 daily. slaughter: For treatment of 30 to 75 mg laidlomycin pro- bacterial enteritis caused by pionate potassium per head E. coli and bacterial pneu- per day for not more than 5 monia caused by P. days. A withdrawal period multocida organisms sus- has not been established for ceptible to chlortetracycline; this product in pre-rumi- and for increased rate of nating calves. Do not use in weight and improved feed calves to be processed for efficiency. veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter. (vi) 10 mg/lb of body weight Laidlomycin, 5 to Cattle fed in confinement for Feed continuously at a rate of 054771 daily. 10. slaughter: For treatment of 30 to 75 mg laidlomycin pro- bacterial enteritis caused by pionate potassium per head E. coli and bacterial pneu- per day for not more than 5 monia caused by P. days. A withdrawal period multocida organisms sus- has not been established for ceptible to chlortetracycline; this product in pre-rumi- and for improved feed effi- nating calves. Do not use in ciency. calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter. (vii) 500 to 2,000 to provide Lasalocid, 10 to 30 Cattle fed in confinement for Feed continuously in complete 054771 10 mg/lb of body weight slaughter: For treatment of feed for not more than 5 069254 daily. bacterial enteritis caused by days to provide 10 mg E. coli and bacterial pneu- chlortetracycline per lb. monia caused by P. body weight per day and not multocida organisms sus- less than 100 mg or more ceptible to chlortetracycline; than 360 mg lasalocid per and for improved feed effi- head per day. Do not allow ciency. horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter.

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

(viii) 500 to 1,200 to pro- Lasalocid, 25 to 30 Cattle fed in confinement for Feed continuously in complete 054771 vide 10 mg/lb of body slaughter: For treatment of feed for not more than 5 069254 weight daily. bacterial enteritis caused by days to provide 10 mg E. coli and bacterial pneu- chlortetracycline per lb. monia caused by P. body weight per day and not multocida organisms sus- less than 250 mg or more ceptible to chlortetracycline; than 360 mg lasalocid per and for increased rate of head per day. Do not allow weight gain and improved horses or other equines ac- feed efficiency. cess to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. (ix) 500 to 4,000 to provide Lasalocid, 30 to Pasture cattle (slaughter, Feed continuously on a hand- 054771 10 mg/lb of body weight 600. stocker, feeder cattle, dairy fed basis for not more than 069254 daily. and beef replacement heif- 5 days to provide 10 mg ers): For treatment of bac- chlortetracycline per lb. terial enteritis caused by E. body weight per day and not coli and bacterial pneu- less than 60 mg or more monia caused by P. than 300 mg lasalocid per multocida organisms sus- head per day in at least 1 ceptible to chlortetracycline; pound of feed. Daily and for increased rate of lasalocid intakes in excess weight gain. of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/ day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. (x) 500 to 4,000 g/ton ...... Calves, beef and nonlactating Feed continuously for not 054771 dairy cattle: For the treat- more than 5 days to provide 069254 ment of bacterial enteritis 10 mg/lb body weight per caused by E. coli and bac- day. To sponsor No. 054771 terial pneumonia caused by under NADA 046–699: 24- P. multocida susceptible to hour withdrawal period. To chlortetracycline. sponsor No. 054771 under NADA 048–761 and No. 069254 under ANADA 200– 510: Zero withdrawal period.

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

(xi) 500 to 4,000 ...... Decoquinate, 12.9 Calves, beef and non-lactating Feed at a rate of 1g chlortetra- 054771 to 90.8. dairy cattle: For the treat- cycline per 100 lb body 069254 ment of bacterial enteritis weight/day and 22.7 mg caused by E. coli and bac- decoquinate per 100 lb of terial pneumonia caused by body weight/day for not P. multocida organisms sus- more than 5 days. When it ceptible to chlortetracycline; is fully consumed, resume and for the prevention of feeding 22.7 mg coccidiosis caused by decoquinate per 100 lb of Eimeria bovis and E. zuernii. body weight/day for a total of 28 days to prevent coccidiosis. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in § 510.600(c) of this chapter. (xii) 4,000 to 20,000 g/ton ...... Calves, beef and nonlactating As a top dress, varying with 054771 dairy cattle: For the treat- body weight and feed con- 069254 ment of bacterial enteritis sumption, to provide 10 mg/ caused by E. coli and bac- lb per day. Treat for not terial pneumonia caused by more than 5 days. See P. multocida organisms sus- paragraph (d)(3) of this sec- ceptible to chlortetracycline. tion. (xiii) 4,000 to 20,000 g/ton Decoquinate, 90.8 Calves, beef and non-lactating Administer as a top dress sup- 054771 to 535.7. dairy cattle: For the treat- plement or mix into the daily ment of bacterial enteritis ration to provide 22.7 mg caused by E. coli and bac- decoquinate per 100 lb of terial pneumonia caused by body weight per day and 1 P. multocida organisms sus- g chlortetracycline per 100 ceptible to chlortetracycline; lb body weight/day for not and for the prevention of more than 5 days. When it coccidiosis caused by E. is fully consumed, resume bovis and E. zuernii. feeding 22.7 mg decoquinate per 100 lb of body weight/day for a total of 28 days to prevent coccidiosis. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in § 510.600(c) of this chapter. (xiv) 70 mg/head/day ...... Growing cattle (over 400 lb): See paragraph (d)(3) of this 054771 For reduction of incidence of section. 066104 liver abscesses. 069254 (xv) 350 mg/head/day ...... 1. Beef cattle: For control of To sponsor No. 054771 under * bacterial pneumonia associ- NADAs 046–699 and 049– ated with shipping fever 287, No. 066104 under complex caused by NADA 092–286, and No. Pasteurella spp. susceptible 069254 under NADA 048– to chlortetracycline. 480: Withdraw 48 hours prior to slaughter. To sponsor No. 069254 under NADA 138–935 and ANADA 200–510: Zero withdrawal period.

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

2. Beef cattle (under 700 lb): To sponsor No. 054771 under * For control of active infec- NADAs 046–699 and 049– tion of anaplasmosis caused 287, No. 066104 under by A. marginale susceptible NADA 092–286, and No. to chlortetracycline. 069254 under NADA 048– 480: Withdraw 48 h prior to slaughter. To sponsor No. 054771 under NADA 048– 761 and No. 069254 under NADA 138–935 and ANADA 200–510: Zero withdrawal time. (xvi) 20 to 350 g/ton ...... Beef cattle and replacement Feed to provide chlortetra- 054771 dairy heifers: For control of cycline at the rate of 350 bacterial pneumonia associ- mg per head per day. This ated with shipping fever drug is not approved for use complex caused by in female dairy cattle 20 Pasteurella spp. susceptible months of age or older, in- to chlortetracycline. cluding dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. To sponsor No. 054771 under NADA 048– 761: Zero withdrawal period. (xvii) 350 mg/head/day ...... Laidlomycin, 5 ...... Cattle fed in confinement for Feed continuously at a rate of 054771 slaughter: For control of 30 to 75 mg laidlomycin pro- bacterial pneumonia associ- pionate potassium per head ated with shipping fever per day. A withdrawal period complex caused by has not been established for Pasteurella spp. susceptible this product in pre-rumi- to chlortetracycline; and for nating calves. Do not use in increased rate of weight and calves to be processed for improved feed efficiency. veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter. (xviii) 350 mg/head/day ...... Laidlomycin, 5 to Cattle fed in confinement for Feed continuously at a rate of 054771 10. slaughter: For control of 30 to 75 mg laidlomycin pro- bacterial pneumonia associ- pionate potassium per head ated with shipping fever per day. A withdrawal period complex caused by has not been established for Pasteurella spp. susceptible this product in pre-rumi- to chlortetracycline; and for nating calves. Do not use in improved feed efficiency. calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter.

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

(xix) 25 to 42.2 g/ton to Lasalocid, 25 to 30 Cattle under 700 pounds fed Feed continuously in complete 054771 provide 350 mg/head/day. in confinement for slaughter: feed at a rate of 350 mg 069254 For control of active infec- chlortetracycline and not tion of anaplasmosis caused less than 250 mg nor more by A. marginale susceptible than 360 mg lasalocid per to chlortetracycline; and for head daily. Do not allow increased rate of weight horses or other equines ac- gain and improved feed effi- cess to feeds containing ciency. lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. (xx) 25 to 42.2 g/ton to pro- Lasalocid, 25 to 30 Cattle fed in confinement for Feed continuously in complete 054771 vide 350 mg/head/day. slaughter: For control of feed at a rate of 350 mg 069254 bacterial pneumonia associ- chlortetracycline and not ated with shipping fever less than 250 mg nor more complex caused by P. than 360 mg lasalocid per multocida organisms sus- head daily. Do not allow ceptible to chlortetracycline; horses or other equines ac- and for increased rate of cess to feeds containing weight gain and improved lasalocid. No withdrawal pe- feed efficiency. riod is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. (xxi) 25 to 100 g/ton to pro- Lasalocid, 10 to 30 Cattle under 700 pounds fed Feed continuously in complete 054771 vide 350 mg/head/day. in confinement for slaughter: feed at a rate of 350 mg 069254 For control of active infec- chlortetracycline and not tion of anaplasmosis caused less than 100 mg nor more by A. marginale susceptible than 360 mg lasalocid per to chlortetracycline; and for head daily. Do not allow improved feed efficiency. horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter.

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

(xxii) 25 to 100 g/ton to pro- Lasalocid, 10 to 30 Cattle fed in confinement for Feed continuously in complete 054771 vide 350 mg/head/day. slaughter: For control of feed at a rate of 350 mg 069254 bacterial pneumonia associ- chlortetracycline and not ated with shipping fever less than 100 mg nor more complex caused by P. than 360 mg lasalocid per multocida organisms sus- head daily. Do not allow ceptible to chlortetracycline; horses or other equines ac- and for improved feed effi- cess to feeds containing ciency. lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. (xxiii) 25 to 700 to provide Lasalocid, 30 to Pasture cattle (slaughter, Feed continuously on a hand- 054771 350 mg/head/day. 600. stocker, feeder cattle, dairy fed basis at a rate of 350 069254 and beef replacement heif- mg chlortetracycline and not ers): For control of bacterial less than 60 mg nor more pneumonia associated with than 300 mg lasalocid per shipping fever complex head per day in at least 1 caused by P. multocida or- pound of feed. Daily ganisms susceptible to lasalocid intakes in excess chlortetracycline; and for in- of 200 mg/head/day in pas- creased rate of weight gain. ture cattle have not been shown to be more effective than 200 mg lasalocid/head/ day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. (xxiv) 25 to 700 to provide Lasalocid, 30 to Pasture cattle (slaughter, Feed continuously on a hand- 054771 350 mg/head/day. 600. stocker, feeder cattle, beef fed basis at a rate of 350 069254 replacement heifers) under mg chlortetracycline and not 700 pounds: For control of less than 60 mg nor more active infection of than 300 mg lasalocid per anaplasmosis caused by A. head per day in at least 1 marginale susceptible to pound of feed. Daily chlortetracycline; and for in- lasalocid intakes in excess creased rate of weight gain. of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/ day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter.

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

(xxv) 25 to 2,800 to provide Lasalocid, 30 to Beef cattle weighing under Hand feed continuously at a 054771 350 mg/head/day. 181.8. 700 pounds: For control of rate of 350 mg chlortetra- 069254 active infection of cycline and 1 mg lasalocid anaplasmosis caused by per 2.2 lb. body weight daily Anaplasma marginale sus- to cattle with a maximum of ceptible to chlortetracycline; 360 mg of lasalocid per and for the control of coc- head per day. Do not allow cidiosis caused by Eimeria horses or other equines ac- bovis and E. zuernii. cess to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Chlortetracycline and lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. (xxvi) 25 to 2,800 to pro- Lasalocid, 30 to Beef cattle weighing up to 800 Hand feed continuously at a 054771 vide 350 mg/head/day. 181.8. pounds: For control of bac- rate of 350 mg chlortetra- 069254 terial pneumonia associated cycline and 1 mg lasalocid with shipping fever complex per 2.2 lb. body weight daily caused by Pasteurella spp. to cattle with a maximum of susceptible to chlortetra- 360 mg of lasalocid per cycline; and for the control head per day. Do not allow of coccidiosis caused by E. horses or other equines ac- bovis and E. zuernii. cess to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. (xxvii) 500 to 4,000 to pro- Lasalocid, 30 to Cattle weighing up to 800 Hand feed continuously for not 054771 vide 10 mg/head/day. 181.8. pounds: For the treatment of more than 5 days at a rate 069254 bacterial enteritis caused by of 10 mg chlortetracycline E. coli and bacterial pneu- and 1 mg lasalocid per 2.2 monia caused by P. lb. body weight daily to cat- multocida susceptible to tle with a maximum of 360 chlortetracycline; and for the mg of lasalocid per head control of coccidiosis per day. Do not allow caused by Eimeria bovis horses or other equines ac- and E. zuernii. cess to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter.

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

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Chlortetracycline amount Indications for use Limitations Sponsor

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

(6) It is used as a free-choice, loose (v) Sponsors. See Nos. 054771 and mineral Type C feed as follows: 069254 in § 510.600(c) of this chapter. (i) Specifications. [81 FR 94995, Dec. 27, 2016, as amended at 82 International feed FR 21691, May 10, 2017; 82 FR 43485, Sept. 18, Ingredient Percent No. 2017; 83 FR 13636, Mar. 30, 2018; 83 FR 14588, Apr. 5, 2018; 83 FR 48947, Sept. 28, 2018; 83 FR Dicalcium Phos- 64741, Dec. 18, 2018; 84 FR 8975, Mar. 13, 2019; phate ...... 46.20 6–26–335 84 FR 39185, Aug. 9, 2019] Sodium Chloride (Salt) ...... 15.00 6–04–152 Magnesium Oxide 10.67 6–02–756 § 558.140 Chlortetracycline and Cottonseed Meal ... 10.00 5–01–625 sulfamethazine. Trace Mineral/Vita- (a) Specifications. Type A medicated min Premix 1 ...... 3.80 Calcium Carbonate 3.50 6–01–069 articles containing: Dried Cane Molas- (1) 35 grams (g) per pound (/lb) each, ses ...... 3.00 4–04–695 chlortetracycline and sulfamethazine. Potassium Chloride 2.00 6–03–755 (2) 40 g/lb each, chlortetracycline and Mineral Oil ...... 2.00 8–03–123 Iron Oxide ...... 0.50 6–02–431 sulfamethazine. Chlortetracycline (b) Sponsors. See sponsors numbers in Type A medi- § 510.600(c) of this chapter as follow: cated article (90 gram/lb) ...... 3.33 (1) Nos. 054771 and 069254 for use of product described in paragraph (a)(1) as 1 Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for in paragraph (e)(1) of this section. other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with (2) Nos. 054771 and 069254 for use of 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) product described in paragraph (a)(2) as should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18). in paragraph (e)(2) of this section. (c) Related tolerances. See §§ 556.150 (ii) Amount. 6,000 grams per ton. and 556.670 of this chapter. (iii) Indications for use. Beef and (d) Special considerations. (1) Federal nonlactating dairy cattle: As an aid in law restricts medicated feed containing the control of active infection of this veterinary feed directive (VFD) anaplasmosis caused by Anaplasma drug to use by or on the order of a li- marginale susceptible to chlortetra- censed veterinarian. See § 558.6 for addi- cycline. tional requirements. (iv) Limitations. Feed continuously on (2) The expiration date of VFDs for a free-choice basis at a rate of 0.5 to 2.0 chlortetracycline and sulfamethazine mg chlortetracycline per pound of body medicated feeds must not exceed 6 weight per day. months from the date of issuance. VFDs for chlortetracycline and sulfamethazine shall not be refilled. (e) Conditions of use— (1) Cattle—

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Chlortetracycline and sulfamethazine amount Indications for use Limitations Sponsors

(i) To provide 350 milligrams Beef cattle: For aid in the Feed for 28 days; withdraw 7 054771 per head per day each, maintenance of weight days prior to slaughter. A 069254 chlortetracycline and gains in the presence of withdrawal period has not sulfamethazine. respiratory disease such as been established for this shipping fever. product in pre-ruminating calves. Do not use in calves to be processed for veal. (ii) [Reserved]

(2) Swine—

Chlortetracycline and sulfamethazine amount Indications for use Limitations Sponsors

(i) 100 g/ton of feed each, Swine: For reduction of the Feed as the sole ration. With- 054771 chlortetracycline and incidence of cervical ab- draw 15 days prior to 069254 sulfamethazine. scesses; treatment of bac- slaughter. terial swine enteritis (salmonellosis or necrotic enteritis caused by Sal- monella choleraesuis and vibrionic dysentery); prevention of these diseases during times of stress; and maintenance of weight gains in the presence of atrophic rhinitis. (ii) [Reserved]

[79 FR 37622, July 2, 2014, as amended at 80 (b) Sponsor. See No. 016592 in FR 13231, Mar. 13, 2015; 81 FR 63054, Sept. 14, § 510.600(c) of this chapter. 2016; 81 FR 95004, Dec. 27, 2016; 82 FR 21691, (c) Related tolerances. See § 556.160 of May 10, 2017; 84 FR 12495, Apr. 2, 2019] this chapter. § 558.175 Clopidol. (d) Conditions of use—(1) Chickens— (a) Specifications. Type A medicated article containing 25 percent clopidol.

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

(i) 113.5...... Broiler chickens and re-placement Do not feed to chickens over 016592 chickens intended for use as 16 weeks of age. caged layers: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.. (ii) 113.5 ...... Bacitracin Broiler chickens: As an aid in the Feed continuously as the sole 016592 methylenedisalicy- prevention of coccidiosis caused ration from the time chicks late, 4 to 50. by Eimeria tenella, E. necatrix, E. are placed in floor pens until acervulina, E. maxima, E. brunetti, slaughter. Do not feed to and E. mivati, and for increased chickens over 16 weeks of rate of weight gain.. age; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter.

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

(iii) 113.5 ...... Bacitracin zinc, 5 to Broiler chickens: As an aid in the Feed continuously as sole ra- 054771 25. prevention of coccidiosis caused tion; bacitracin zinc as pro- 016592 by Eimeria tenella, E. necatrix, E. vided by No. 054771 in acervulina, E. maxima, E. brunetti, § 510.600(c) of this chapter. and E. mivati, and for increased rate of weight gain and improved feed efficiency.. (iv) 113.5 ...... Bambermycins, 1 to Broiler chickens: As an aid in preven- Feed continuously as the sole 016592 2. 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.. (v) 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 an aid in the prevention of coccidi- of age if intended for use as osis caused by Eimeria tenella, E. caged layers; withdraw 5 necatrix, E. acervulina, E. maxima, days before slaughter if E. brunetti, and E. mivati.. given at the level of 0.025 percent in feed or reduce level to 0.0125 percent 5 days before slaughter. (vi) 227 ...... Bambermycins, 1 to Broiler chickens: As an aid in preven- Feed continuously as sole ra- 016592 2. 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.

(2) Turkeys—

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

(i) 113.5 or 227 ...... Turkeys: As an aid in the prevention For turkeys grown for meat 016592 of leucocytozoonosis caused by purposes only; feed continu- Leucocytozoon smithi.. ously 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. (ii) [Reserved]

(3) Clopidol may also be used in com- (4) Lincomycin as in § 558.325. bination with: [68 FR 17882, Apr. 14, 2003, as amended at 72 (i)–(ii) [Reserved] FR 60551, Oct. 25, 2007; 74 FR 61028, Nov. 23, (iii) Chlortetracycline as in § 558.128. 2009; 79 FR 10965, 10982, Feb. 27, 2014; 79 FR (iv) Lincomycin as in § 558.325. 13545, Mar. 11, 2014; 81 FR 17609, Mar. 30, 2016; (e) Clopidol may also be used in com- 81 FR 95004, Dec. 27, 2016; 84 FR 12495, Apr. 2, bination with: 2019] (1)–(2) [Reserved] § 558.195 Decoquinate. (3) Chlortetracycline as in § 558.128. (a) Specifications. Type A medicated article containing 6 percent decoquinate. (b) Approvals. See No. 054771 in § 510.600(c) of this chapter.

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(c) Related tolerances. See § 556.170 of (3) Type C cattle feeds may be manu- this chapter. factured from decoquinate liquid Type (d) Special considerations. (1) Ben- B feeds having a pH between 5.0 to 6.5 tonite should not be used in and containing a suspending agent to decoquinate feeds. maintain a viscosity of not less than (2) Type A medicated articles may be 500 centipoises. used to manufacture dry or liquid Type (e) Conditions of use. It is used as fol- B cattle (including veal calf), sheep, lows: and goat feeds as in paragraphs (e)(2) (1) — and (e)(3) of this section. Chickens

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

(i) 27.2...... Broiler chickens: For prevention of Do not feed to laying hens pro- 054771 coccidiosis caused by Eimeria ducing eggs for human con- tenella, E. necatrix, E. mivati, E. sumption. acervulina, E. maxima, and E. brunetti. (ii) 27.2 ...... Bacitracin Broiler chickens: For prevention of Feed continuously as sole ra- 054771 methylenedisalicy- coccidiosis caused by Eimeria tion; do not feed to laying late, 4 to 50. tenella, E. necatrix, E. mivati, E. chickens. Bacitracin acervulina, E. maxima, and E. methylenedisalicylate as pro- brunetti; and for increased rate of vided by No. 054771 in weight gain and improved feed effi- § 510.600(c) of this chapter. ciency. (iii) 27.2 ...... Bacitracin zinc, 10 to Broiler chickens: For prevention of Feed continuously as sole ra- 054771 50. coccidiosis caused by Eimeria tion; do not feed to laying tenella, E. necatrix, E. mivati, E. chickens. Bacitracin zinc as acervulina, E. maxima, and E. provided by No. 054771 in brunetti. § 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 human consumption. See paragraph (d)(3) of this section. (ii) 12.9 to 90.8 Monensin, 5 to 30 ... Cattle fed in confinement for slaugh- Feed continuously as the sole 016592, ter: For prevention of coccidiosis ration to provide 22.7 mg of 054771 caused by Eimeria bovis and E. decoquinate per 100 lb of zuernii; and for improved feed effi- body weight per day and 50 ciency. 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)(9)(i). Monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter.

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

(iii) 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 For prevention of coccidiosis or mix into the daily ration to caused by Eimeria bovis and E. provide 22.7 mg per 100 lb zuernii. 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.

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

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(4) Decoquinate may also be used in been manufactured. Do not mix in combination with: feeds to be pelleted nor with pelleted (i)–(ii) [Reserved] feed. Do not soak the feed or admin- (iii) Chlortetracycline as in § 558.128. ister as wet mash. Feed must be dry (iv) Lincomycin as in § 558.325. when administered. Do not use in animals other than swine. Do not allow [67 FR 72370, Dec. 5, 2002; 68 FR 15372, Mar. 31, fowl access to feed containing this 2003; 69 FR 26499, May 13, 2004; 69 FR 52816, preparation or to feces from treated Aug. 30, 2004; 69 FR 62407, Oct. 26, 2004; 69 FR animals. 67264, Nov. 17, 2004; 70 FR 2567, Jan. 14, 2005; 78 FR 25183, Apr. 30, 2013; 79 FR 10982, Feb. 27, (2) Dichlorvos is a cholinesterase in- 2014; 79 FR 13545, Mar. 11, 2014; 79 FR 17860, hibitor. Do not use this product in ani- Mar. 31, 2014; 80 FR 13231, Mar. 13, 2015; 81 FR mals simultaneously or within a few 17609, Mar. 30, 2016; 81 FR 22525, Apr. 18, 2016; days before or after treatment with or 81 FR 67152, Sept. 30, 2016; 81 FR 95004, Dec. exposure to cholinesterase-inhibiting 27, 2016; 83 FR 48947, Sept. 28, 2018; 84 FR drugs, pesticides, or chemicals. If 12496, Apr. 2, 2019; 85 FR 18121, Apr. 1, 2020] human or animal poisoning should occur, immediately consult a physician § 558.198 Dichlorvos. or a veterinarian. Atropine is anti- (a) Specifications. Each pound of Type dotal. A medicated article containing 3.1 or (3) Labeling for Type A articles and 9.6 percent dichlorvos. Type B feeds must include a statement (b) Sponsor. See No. 054628 in that containers or materials used in § 510.600(c) of this chapter. packaging such Type A articles and (c) Related tolerances. See § 556.180 of Type B feeds are not to be reused and this chapter. all such packaging materials must be (d) Special considerations—(1) destroyed after the product has been Dichlorvos is to be included in meal or used. mash or mixed with feed in crumble (e) Conditions of use. It is used in form only after the crumble feed has swine feed as follows:

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

(i) 348 ...... Swine up to 70 pounds body weight: Feed as sole ration for 2 con- 054628 For the removal and control of ma- secutive days. For swine ture, immature, and/or fourth-stage from 70 pounds to market larvae of the whipworm (Trichuris weight, feed as sole ration at suis), nodular worm the rate of 8.4 pounds of (Oesophagostomum sp.), large feed per head until the medi- roundworm (Ascaris suum) and the cated feed has been con- thick stomach worm (Ascarops sumed. For boars, open or strongylina) of the gastrointestinal bred gilts, and sows, feed as tract.. sole ration at the rate of 4.2 pounds per head per day for 2 consecutive days.. (ii) 479 ...... Boars, open or bred gilts, and sows: Feed as sole ration at the rate 054628 For the removal and control of ma- of 6 pounds per head for ture, immature, and/or fourth-stage one feeding.. larvae of the whipworm (Trichuris suis), nodular worm (Oesophagostomum sp.), large roundworm (Ascaris suum) and the thick stomach worm (Ascarops strongylina) of the gastrointestinal tract..

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

(iii) 334 to 500 ... Pregnant swine: An aid in improving Mix into a gestation feed to 054628 litter production efficiency by in- provide 1,000 milligrams per creasing pigs born alive, birth head daily during last 30 weights, survival to market, and days of gestation.. rate of weight gain. Treatment also removes and controls mature, immature and/or fourth stage larvae of whipworm (Trichuris suis), nodular worm (Oesophagostomum spp.) large roundworm (Ascaris suum), and the thick stomach worm (Ascarops strongylina) occurring in the gastrointestinal tract of the sow or gilt..

[84 FR 12497, Apr. 2, 2019] (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. § 558.205 Diclazuril. (c) Related tolerances. See § 556.185 of (a) Specifications. Type A medicated this chapter. article containing 0.2 percent (d) Conditions of use—(1) Chickens. For diclazuril. chickens it is used as follows:

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

(i) 0.91 ...... Broiler chickens: For the prevention Feed continuously. Not for use 058198 of coccidiosis caused by Eimeria in hens producing eggs for tenella, E. necatrix, E. acervulina, human food. Because E. brunetti, E. mitis (mivati), and E. diclazuril is effective against maxima. 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 ...... Bacitracin Broiler chickens: For the prevention Feed continuously. Not for use 058198 methylenedisalicy- of coccidiosis caused by Eimeria in hens producing eggs for late, 4 to 50. tenella, E. necatrix, E. acervulina, human food. Because E. brunetti, E. mitis (mivati), and E. diclazuril is effective against maxima, and for increased rate of E. maxima later in its life weight gain and improved feed effi- cycle, subclinical intestinal ciency. 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. Bac- itracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter.

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

(iii) 0.91 ...... Bambermycins, 1 to Broiler chickens: For the prevention Feed continuously. Not for use 058198 2. of coccidiosis caused by Eimeria in hens producing eggs for tenella, E. necatrix, E. acervulina, human food. Because E. brunetti, E. mitis (mivati), and E. diclazuril is effective against maxima, and for increased rate of E. maxima later in its life weight gain and improved feed effi- cycle, subclinical intestinal ciency. 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. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter.

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

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

(i) 0.91 ...... Growing turkeys: For the prevention Feed continuously as the sole 058198 of coccidiosis caused by Eimeria ration. Do not feed to breed- adenoeides, E. gallopavonis and ing turkeys. Not for use in E. meleagrimitis.. hens producing eggs for human consumption.. (ii) 0.91 ...... Bacitracin Growing turkeys: For the prevention Feed continuously as the sole 058198 methylenedisalicy- of coccidiosis caused by Eimeria ration. Do not feed to breed- late, 4 to 50. adenoeides, E. gallopavonis and ing turkeys. Not for use in E. meleagrimitis, and for increased hens producing eggs for rate of weight gain and improved human consumption. Baci- feed efficiency. tracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. (iii) 0.91 ...... Bambermycins, 1 to Growing turkeys: For the prevention Feed continuously as the sole 058198 2. of coccidiosis caused by Eimeria ration. Do not feed to breed- adenoeides, E. gallopavonis and ing turkeys. Not for use in E. meleagrimitis, and for improved hens producing eggs for feed efficiency. human consumption. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. (iv) 0.91 ...... Bambermycins, 2 .... Growing turkeys: For the prevention Feed continuously as the sole 058198 of coccidiosis caused by Eimeria ration. Do not feed to breed- adenoeides, E. gallopavonis and ing turkeys. Not for use in E. meleagrimitis, and for increased hens producing eggs for rate of weight gain and improved human consumption. feed efficiency. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter.

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(3) Diclazuril may also be used in (B) Limitations. Feed continuously as combination with virginiamycin as in sole ration. Not to be used in swine § 558.635. weighing more than 250 pounds. [64 FR 35923, July 2, 1999, as amended at 65 (2) [Reserved] FR 50134, Aug. 17, 2000; 66 FR 47962, 47963, [57 FR 38442, Aug. 25, 1992, as amended at 62 Sept. 17, 2001; 66 FR 62917, Dec. 4, 2001; 67 FR FR 63271, Nov. 28, 1997; 84 FR 33001, July 11, 34830, May 16, 2002; 67 FR 47257, July 18, 2002; 67 FR 48549, July 25, 2002; 69 FR 9947, Mar. 3, 2019; 84 FR 39185, Aug. 9, 2019] 2004; 72 FR 60552, Oct. 25, 2007; 79 FR 10982, Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014; 81 FR § 558.248 Erythromycin. 17609, Mar. 30, 2016; 81 FR 95004, Dec. 27, 2016. (a) Specifications. Type A medicated Redesignated and amended at 84 FR 12497, 12498, Apr. 2, 2019] articles containing 92.5 grams per pound erythromycin (as the § 558.235 Efrotomycin. thiocyanate salt). (a) Specifications. Type A medicated (b) Sponsor. See No. 061133 in articles containing 14.5 grams § 510.600(c) of this chapter. efrotomycin per pound. (c) Related tolerances. See § 556.230 of (b) Sponsor. See No. 000010 in this chapter. § 510.600(c) of this chapter. (d) Special considerations. (1) Federal (c) Related tolerances. See § 556.224 of law restricts medicated feed containing this chapter. this veterinary feed directive (VFD) (d) Conditions of use—(1) Swine—(i) drug to use by or on the order of a li- Amount. 3.6 grams per ton. censed veterinarian. See § 558.6 for addi- (A) Indications for use. For improved tional requirements. feed efficiency. (2) The expiration date of VFDs for (B) Limitations. Feed continuously as erythromycin medicated feeds must sole ration. Not to be used in swine weighing more than 250 pounds. not exceed 6 months from the date of (ii) Amount. 3.6 to 14.5 grams per ton. issuance. VFDs for erythromycin shall (A) Indications for use. For increased not be refilled. rate of weight gain. (e) Conditions of use—(1) Chickens—

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

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

(2) Turkeys—

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

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

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[41 FR 10999, Mar. 15, 1976, as amended at 45 (b) Sponsor. See No. 000061 in FR 56799, Aug. 26, 1980; 49 FR 31281, Aug. 6, § 510.600(c) of this chapter. 1984; 51 FR 7397, Mar. 3, 1986; 52 FR 2684, Jan. (c) Related tolerances. See § 556.273 of 26, 1987; 54 FR 12189, Mar. 24, 1989; 66 FR 14074, this chapter. Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 79 FR (d) Special considerations. Famphur is 10982, Feb. 27, 2014; 81 FR 36790, June 8, 2016; a cholinesterase inhibitor. Do not use 81 FR 95004, Dec. 27, 2016; 84 FR 8975, Mar. 13, 2019] this product in animals simultaneously or within a few days before or after § 558.254 Famphur. treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or (a) Specifications. Type A medicated chemicals. articles containing 13.2 or 33.3 percent (e) Conditions of use. It is used in cat- famphur. tle feed as follows:

TABLE 2—SIZE PROXIES FOR SRCSIN2016

Famphur in grams/ton Indications for use Limitations Sponsor

(i) 1.1 milligrams per Beef cattle and nonlactating dairy cows: Feed for 30 days. Withdraw from dry dairy 000061 pound (mg/lb) body For control of grubs and as an aid in cows and heifers 21 days prior to fresh- weight per day. control of sucking lice. ening. Withdraw 4 days prior to slaughter. (ii) 2.3 mg/lb body Beef cattle and nonlactating dairy cows: Feed for 10 days. Withdraw from dry dairy 000061 weight per day. For control of grubs. cows and heifers 21 days prior to freshening. Withdraw 4 days prior to slaughter.

[84 FR 39185, Aug. 9, 2019] (b) Approvals. See No. 000061 in § 510.600(c) of this chapter. § 558.258 Fenbendazole. (c) Related tolerances. See § 556.275 of (a) Specifications. Type A medicated this chapter. articles: 4 percent (18.1 grams per (d) Special considerations. See § 500.25 pound (g/lb)), 8 percent (36.2 g/lb), and of this chapter. 20 percent (90.7 g/lb) fenbendazole. (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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Fenbendazole in Combination in grams per ton grams per ton Indications for use Limitations Sponsors

(i) 10 to 300 (to For the removal and control of adult Feed as the 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 lung, intestinal forms) large weight) given roundworms (Ascaris suum); adult over a 3- to stage nodular worms 12-day period. (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 300 (to Bacitracin Growing/finishing swine: For the re- Feed as the sole ration. Under 054771 provide 9 mg/ methylenedisalicy- moval and control of adult stage conditions of continued ex- kg of body late, 10 to 30. lungworms (Metastrongylus apri posure to parasites, retreat- weight). and M. pudendotectus); adult and ment may be needed after 4 larvae (L3, 4 stages—liver, lung, to 6 weeks. Bacitracin intestinal forms) large roundworms methylenedisalicylate as pro- (Ascaris suum); adult stage nod- vided by No. 054771 in ular worms (Oesophagostomum § 510.600(c) of this chapter. 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); and for increased rate of weight gain and improved feed efficiency. (iii) 10 to 300 (to Bacitracin 1. Growing/finishing swine: For the 1. Growing/finishing swine: 054771 provide 9 mg/ methylenedisalicy- removal and control of adult stage Feed as sole ration. Not for kg of body late, 250. lungworms (Metastrongylus apri use in growing and finishing weight). and M. pudendotectus); adult and swine that weigh more than larvae (L3, 4 stages—liver, lung, 250 lbs. Diagnosis of swine intestinal forms) large roundworms dysentery should be con- (Ascaris suum); adult stage nod- firmed by a veterinarian ular worms (Oesophagostomum when results are not satis- dentatum, O. quadrispinulatum); factory. Under conditions of adult stage small stomach worms continued exposure to (Hyostrongylus rubidus); adult and parasites, retreatment may larvae (L2, 3, 4 stages—intestinal be needed after 4 to 6 mucosal forms) whipworms weeks. Bacitracin (Trichuris suis); adult and larvae methylenedisalicylate as pro- kidney worms (Stephanurus vided by No. 054771 in dentatus); and for control of swine § 510.600(c) of this chapter. dysentery associated with Treponema hyodysenteriae on premises with a history of swine dysentery, but where signs of disease have not yet occurred; or following an approved treatment of the disease condition.

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Fenbendazole in Combination in grams per ton grams per ton Indications for use Limitations Sponsors

2. Pregnant sows: For the removal 2. Pregnant sows: Feed as and control of adult stage sole ration. Diagnosis of lungworms (Metastrongylus apri clostridial enteritis should be and M. pudendotectus); adult and confirmed by a veterinarian larvae (L3, 4 stages—liver, lung, when results are not satis- intestinal forms) large roundworms factory. Under conditions of (Ascaris suum); adult stage nod- continued exposure to ular worms (Oesophagostomum parasites, retreatment may dentatum, O. quadrispinulatum); be needed after 4 to 6 adult stage small stomach worms weeks. Bacitracin (Hyostrongylus rubidus); adult and methylenedisalicylate as pro- larvae (L2, 3, 4 stages—intestinal vided by No. 054771 in mucosal forms) whipworms § 510.600(c) of this chapter. (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus); for control of clostridial enteritis in suckling pigs caused by Clostridium perfringens.

(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

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Ingredient1 Percent International Feed No.

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

(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.

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Amount Species/Class fenbendazole Indications for use Limitations Sponsor

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

(6) Fenbendazole may also be used in this veterinary feed directive (VFD) combination with: drug to use by or on the order of a li- (i) [Reserved] censed veterinarian. See § 558.6 for addi- (ii) Lincomycin as in § 558.325. tional requirements. [66 FR 58935, Nov. 26, 2001, as amended at 68 (2) The expiration date of VFDs for FR 34534, June 10, 2003; 72 FR 66046, Nov. 27, florfenicol medicated feeds: 2007; 73 FR 58873, Oct. 8, 2008; 74 FR 61517, (i) For swine must not exceed 90 days Nov. 25, 2009; 79 FR 13545, Mar. 11, 2014; 81 FR from the date of issuance. 17609, Mar. 30, 2016; 81 FR 95005, Dec. 27, 2016; 84 FR 12499, Apr. 2, 2019] (ii) For fish must not exceed 6 months from the date of issuance. § 558.261 Florfenicol. (3) VFDs for florfenicol shall not be (a) Specifications. Type A medicated refilled. articles containing florfenicol in the (4) Type A medicated articles and following concentrations: medicated feeds intended for use in fish (1) 40 grams per kilogram for use as shall bear the following: ‘‘Not for use in paragraph (e)(1) of this section. in animals intended for breeding pur- (2) 500 grams per kilogram for use as poses. The effects of florfenicol on rein paragraph (e)(2) of this section. productive performance have not been (b) Sponsor. See No. 000061 in determined. Toxicity studies in dogs, § 510.600(c) of this chapter. rats, and mice have associated the use (c) Related tolerances. See § 556.283 of of florfenicol with testicular degenera- this chapter. tion and atrophy.’’ (d) Special considerations. (1) Federal (e) Conditions of use—(1) Swine— law restricts medicated feed containing

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—

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Florfenicol in grams/ton of feed Indications for use Limitations

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

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

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

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

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

§ 558.265 Halofuginone. (b) Sponsor. See No. 016592 in § 510.600(c) of this chapter. (a) Specifications. Type A medicated (c) See § 556.308 of articles containing 6 grams of Related tolerances. this chapter. halofuginone hydrobromide per kilogram.

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(d) Conditions of use. It is used in feed (1) Chickens— as follows:

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

(i) 2.72 ...... Broiler chickens: For the prevention of Feed continuously as sole ra- 016592 coccidiosis caused by Eimeria tion. Do not feed to layers. tenella, E. necatrix, E. acervulina, Withdraw 4 days before E. brunetti, E. mivati, and E. maxi- slaughter. ma. (ii) 2.72 ...... Bacitracin Broiler chickens: For the prevention of Feed continuously as sole ra- 016592 methylenedisalicyl- coccidiosis caused by Eimeria tion. Do not feed to layers. ate, 10 to 50. tenella, E. necatrix, E. acervulina, Withdraw 5 days before E. brunetti, E. mivati, and E. maxi- slaughter. ma; for improved feed efficiency. (iii) 2.72 ...... Bambermycins, 1 to Broiler chickens: For the prevention of Feed continuously as sole ra- 016592 2. coccidiosis caused by Eimeria tion. Do not feed to layers. tenella, E. necatrix, E, acervulina, Withdraw 5 days before E. brunetti, E. mivati, and E. maxi- slaughter. ma; for increased rate of weight gain and improved feed efficiency. (iv) 2.72 ...... Replacement broiler breeder chickens Feed continuously as sole ra- 016592 and replacement cage laying chick- tion to replacement cage lay- ens: For the prevention of coccidi- ing chickens until 20 weeks osis caused by Eimeria tenella, E. of age. Feed continuously as necatrix, E. acervulina, E. maxima, sole ration to replacement E. mivati/E. mitis, and E. brunetti. broiler breeder chickens until 16 weeks of age. Do not feed to laying chickens or water fowl. Withdraw 4 days before slaughter.

(2) Turkeys—

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

(i) 1.36 to 2.72 ...... Growing turkeys: For the prevention Feed continuously as sole ra- 016592 of coccidiosis caused by Eimeria tion. Withdraw 7 days before adenoeides, E. meleagrimitis, and slaughter. Do not feed to lay- E. gallopavonis. ers or water fowl. (ii) 1.36 to 2.72 ... Bacitracin Growing turkeys: For the prevention Feed continuously as sole ra- 016592 methylenedisalicyl- of coccidiosis caused by Eimeria tion. Withdraw 7 days before ate, 10 to 50. adenoeides, E. meleagrimitis, and slaughter. Do not feed to lay- E. gallopavonis, and for increased ing chickens or water fowl. rate of weight gain. (iii) 1.36 to 2.72 .. Bambermycins, 2 ..... Growing turkeys: For the prevention Feed continuously as sole ra- 016592 of coccidiosis caused by Eimeria tion. Withdraw 7 days before adenoeides, E. meleagrimitis, and slaughter. Do not feed to lay- E. gallopavonis, and for increased ing chickens or waterfowl. rate of weight gain.

(3) Halofuginone may also be used in (ii) [Reserved] combination with: [50 FR 33719, Aug. 21, 1985, as amended at 50 (i) Lincomycin as in § 558.325. FR 42518, Oct. 21, 1985; 51 FR 7397, Mar. 3, 1986; 51 FR 11439, Apr. 3, 1986; 51 FR 14989, Apr. 22, 1986; 51 FR 23737, July 1, 1986; 53 FR 1018, Jan. 15, 1988; 53 FR 11065, Apr. 5, 1988; 54 FR 11519, Mar. 21, 1989; 54 FR 28052, July 5, 1989; 59 FR 51498, Oct. 12, 1994; 61 FR 21076, May 9, 1996; 61 FR 24694, May 16, 1996; 64 FR 42597, Aug. 5, 1999; 65 FR 45712, July 25, 2000; 66 FR 47962, Sept. 17, 2001; 71 FR 27956, May 15, 2006; 79 FR 10982, Feb. 27, 2014; 84 FR 8975, Mar. 13, 2019]

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§ 558.274 Hygromycin B. this veterinary feed directive (VFD) drug to use by or on the order of a li- (a) Specifications. Type A medicated censed veterinarian. See § 558.6 for addi- articles containing 2.4 or 8 grams tional requirements. hygromycin B per pound (g/lb). (2) The expiration date of VFDs for (b) Sponsor. See No. 058198 in hygromycin B medicated feeds must § 510.600(c) of this chapter for as fol- not exceed 6 months from the date of lows: issuance. VFDs for hygromycin B shall (c) Related tolerances. See § 556.330 of not be refilled. this chapter. (e) Conditions of use. It is used in feed (d) Special considerations. (1) Federal as follows: law restricts medicated feed containing (1) Chickens—

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

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

(2) Swine—

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

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

[81 FR 95005, Dec. 27, 2016] must be accompanied with increased feed intake; administration may in- § 558.295 Iodinated casein. crease heat sensitivity of the animal. (a) Approvals. See 017762 in § 510.600(c) of this chapter. [45 FR 41631, June 20, 1980, as amended at 81 FR 67152, Sept. 30, 2016] (b) [Reserved] (c) Conditions of use—(1) Ducks—(i) § 558.300 Ivermectin. Amount per ton. 100 to 200 grams. (ii) Indications for use. For increased (a) Specifications. Type A medicated rate of weight gain and improved feath- article containing 2.72 grams ering in growing ducks. ivermectin per pound (g/lb). (2) Dairy cows—(i) Amount per pound. (b) Sponsor. See No. 000010 in 1⁄2 to 11⁄2 grams per 100 lb of body § 510.600(c) of this chapter. weight. (c) Related tolerances. See § 556.344 of (ii) Indications for use. For increased this chapter. milk production in dairy cows. (d) Special considerations. See § 500.25 (iii) Limitations. This drug is effective of this chapter. for limited periods of time, and the ef- (e) Conditions of use in swine. It is fectiveness is limited to the declining used in feed as follows: phase of lactation. Administration

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

(1) 1.8 ...... Weaned, growing-finishing swine: For Feed as the only feed for 7 000010 treatment and control of gastro- consecutive days to provide intestinal roundworms (Ascaris 0.1 milligrams per kilograms suum, adults and fourth-stage lar- (mg/kg) of body weight per vae; Ascarops strongylina, adults; day. Withdraw 5 days before Hyostrongylus rubidus, adults and slaughter. 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); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis). (2) 1.8 ...... Bacitracin Weaned, growing-finishing swine: For Feed as the only feed for 7 000010 methylenedisalicyl- treatment and control of gastro- consecutive days to provide ate, 10 to 30. intestinal roundworms (Ascaris 0.1 mg/kg of body weight per suum, adults and fourth-stage lar- day. Withdraw 5 days before vae; Ascarops strongylina, adults; slaughter. Hyostrongylus rubidus, adults and 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); lice (Haematopinus suis); and mange mites (Sarcoptes scabieivar. suis); and for increased rate of weight gain and improved feed efficiency. (3) 1.8 ...... Bacitracin Weaned, growing-finishing swine: For Feed as the only feed for 7 000010 methylenedisalicyl- treatment and control of gastro- consecutive days to provide ate, 250. intestinal roundworms (Ascaris 0.1 mg/kg of body weight per suum, adults and fourth-stage lar- day. Withdraw 5 days before vae; Ascarops strongylina, adults; slaughter. Hyostrongylus rubidus, adults and 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); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis); and for control of swine dysentery associated with Treponema hyodysenteriae on 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 grams/ton grams/ton Indications for use Limitations Sponsor

(4) 1.8 to 11.8 .... Adult and breeding swine: For treat- Feed as the only feed for 7 000010 ment and control of gastrointestinal consecutive days to provide roundworms (Ascaris suum, adults 0.1 mg/kg of body weight per and fourth-stage larvae; Ascarops day. Withdraw 5 days before strongylina, adults; Hyostrongylus slaughter. rubidus, adults and 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). (5) 1.8 to 11.8 .... Bacitracin Pregnant sows: For treatment and Feed as the only feed for 7 000010 methylenedisalicyl- control of gastrointestinal consecutive days to provide ate, 250. roundworms (Ascaris suum, adults 0.1 mg/kg of body weight per and fourth-stage larvae; Ascarops day. Withdraw 5 days before strongylina, adults; Hyostrongylus slaughter. Feed bacitracin rubidus, adults and fourth-stage lar- methylenedisalicylate Type C vae; Oesophagostomum spp., medicated feed to sows from adults and fourth-stage larvae); 14 days before through 21 kidneyworms (Stephanurus days after farrowing on prem- dentatus, adults and fourth-stage ises with a history of larvae); lungworms (Metastrongylus clostridial scours. 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); and for control of clostridial enteritis caused by Clostridium perfringens in suckling piglets. (6) 18.2 to 120 ... Adult and breeding swine: For treat- Top dress on daily ration for in- 000010 ment and control of gastrointestinal dividual treatment for 7 con- roundworms (Ascaris suum, adults secutive days to provide 0.1 and fourth-stage larvae; Ascarops mg/kg of body weight per strongylina, adults; Hyostrongylus day. Withdraw 5 days before rubidus, adults and fourth-stage lar- slaughter. vae; 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).

[72 FR 37437, July 10, 2007, as amended at 81 § 558.305 Laidlomycin. FR 17609, Mar. 30, 2016; 81 FR 95005, Dec. 27, 2016; 84 FR 12499, Apr. 2, 2019; 84 FR 39185, (a) Specifications. Type A medicated Aug. 9, 2019] articles containing 50 grams laidlomycin propionate potassium per pound. (b) Approvals. See No. 054771 in § 510.600(c) of this chapter.

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

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

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

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

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(7) 20 percent activity to No. 054771 supplemental new animal drug applica- for use as follows: tion to establish physical stability; and (i) Chukar partridges as in paragraph (iii) Requesting the sponsor of an ap- (e)(1)(xiii). proved new animal drug application to (ii) Turkeys as in paragraph file a supplement to provide for use of (e)(1)(xiv). its lasalocid Type A article in the man- (iii) Rabbits as in paragraph ufacture of the liquid feed specified in (e)(1)(xvi). the appropriate master file. If the data (8) [Reserved] demonstrate the stability of the liquid (9) 15 percent activity to No. 067949 feed described in the master file, the for use in free-choice protein blocks for supplemental new animal drug applica- cattle as in paragraphs (e)(1)(xix) of tion will be approved. The approval this section. will provide a basis for the individual (c) Related tolerance. See § 556.347 of liquid feed manufacturer to manufac- this chapter. ture under a medicated feed license the (d) Special considerations. (1) Type C liquid mediated feed described in the cattle and sheep feeds may be manufac- master file. A manufacturer who seeks tured from lasalocid liquid Type B to market a physically unstable feeds which have a pH of 4.0 to 8.0 and lasalocid liquid feed with mixing direc- bear appropriate mixing directions as tions different from the standard direc- follows: tions established in paragraph (d)(1) of (i) For liquid feeds stored in recircu- this section may also follow this proce- lating tank systems: Recirculate im- dure. mediately prior to use for no less than (4) If adequate information is sub- 10 minutes, moving not less than 1 permitted to show that a particular liquid cent of the tank contents per minute feed containing lasalocid is stable out- from the bottom of the tank to the top. side the pH of 4.0 to 8.0, the pH restric- Recirculate daily as described even tion described in paragraphs (d)(1) and when not used. (d)(2) of this section may be waived. (ii) For liquid feeds stored in me- (5) Required label statements: chanical, air, or other agitation-type (i) For liquid Type B feed (cattle and tank systems: Agitate immediately sheep): Mix thoroughly with grain and/ prior to use for not less than 10 min- or roughage prior to feeding. Feeding utes, creating a turbulence at the bot- undiluted, mixing errors, or inadequate tom of the tank that is visible at the mixing (recirculation or agitation) top. Agitate daily as described even may result in an excess lasalocid con- when not used. centration which could be fatal to cat- (2) A physically stable lasalocid liq- tle and sheep. Do not allow horses or uid feed will not be subject to the re- other equines access to Type A articles quirements for mixing directions pre- or Type B feeds containing lasalocid as scribed in paragraph (d)(1) of this sec- ingestion may be fatal. Safety of tion provided it has a pH of 4.0 to 8.0 lasalocid for use in unapproved species and contains a suspending agent(s) suf- has not been established. ficient to maintain a viscosity of not (ii) For Type A articles or Type B less than 300 centipoises per second for feeds (cattle and sheep): Feeding undi- 3 months. luted or mixing errors may result in an (3) If a manufacturer is unable to excess lasalocid concentration which meet the requirements of paragraph could be fatal to cattle and sheep. Do (d)(1) or (d)(2) of this section, the man- not allow horses or other equines ac- ufacturer may secure approval of a cess to Type A articles or Type B feeds positionally stable liquid feed by: containing lasalocid as ingestion may (i) Either filing a new animal drug be fatal. Safety of lasalocid for use in application for the product or estab- unapproved species has not been establishing a master file containing data to lished. support the stability of its product; (iii) For Type A articles, Type B or (ii) Authorizing the agency to ref- Type C feeds (cattle): A withdrawal pe- erence and rely upon the data in the riod has not been established for this master file to support approval of a product in preruminating calves. Do

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

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

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

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

(xi) 68 (0.0075 Bacitracin zinc 4 to Broiler chickens. For prevention of Feed continuously as sole ra- 054771 pct) to 113 50. coccidiosis caused by Eimeria tion. Bacitracin zinc and (0.0125 pct). tenella, E. necatrix, E. acervulina, lasalocid sodium as provided E. brunetti, E. mivati, and E. maxi- by No. 054771 in ma, and for increased rate of § 510.600(c) of this chapter.. weight gain and improved feed efficiency.. (xii) ...... Pasture cattle (slaughter, stocker, Feed continuously on a free- 054771 feeder cattle, and dairy and beef re- choice basis at a rate of not placement heifers): For increased less than 60 mg or more than rate of weight gain. Intakes of 300 mg of lasalocid per head lasalocid in excess of 200 mg/head/ per day.. day have not been shown to be more effective than 200 mg/head/ day.. (xiii) ...... Cattle; for control of coccidiosis For cattle; hand feed at a rate 054771 caused by Eimeria bovis and of 1 mg of lasalocid per 2.2 Eimeria zuernii. pounds body weight per day to cattle weighing up to 800 pounds with a maximum of 360 mg of lasalocid per head per day. (xiv) 113 (0.0125 ...... Chukar partridges; for prevention of Feed continuously as sole ra- 054771 pct). coccidiosis caused by Eimeria tion up to 8 weeks of age. legionensis. (xv) 68 (0.0075 ...... Growing turkeys; for prevention of Feed continuously as sole ra- 054771 pct) to 113 coccidiosis caused by E. tion. (0.0125 pct). meleagrimitis, E. gallopavonis, and E. adenoeides...... Bacitracin 4 to 50 .... Growing turkeys; for prevention of Feed continuously as sole ra- 054771 coccidiosis caused by E. tion. meleagrimitis, E. gallopavonis, and E. adenoeides; for increased rate of weight gain and improved feed efficiency...... Bacitracin Growing turkeys; for prevention of Feed continuously as sole ra- 054771 methylenedisalicyl- coccidiosis caused by E. tion. Bacitracin ate 4 to 50. meleagrimitis, E. gallopavonis, and methylenedisalicylate as pro- E. adenoeides; for increased rate of vided by No. 054771 in weight gain and improved feed effi- § 510.600(c) of this chapter.. ciency.. (xvi) ...... Replacement calves; for control of In milk replacer powder; hand 054771 coccidiosis caused by E. bovis and feed at a rate of 1 mg of E. zuernii.. lasalocid per 2.2 lb body weight per day; include on labeling warning: ‘‘A withdrawal period has not been established for lasalocid in pre-ruminating calves. Do not use in calves to be processed for veal’’. (xvii) 113 (0.0125 ...... Rabbits; for prevention of coccidiosis Feed continuously as sole ra- 054771 pct). caused by Eimeria stiedae. tion up to 61⁄2 weeks of age. (xviii) 1440...... Pasture cattle (slaughter, stocker, Feed continuously on a free- 021930 feeder cattle, and dairy and beef re- choice basis at a rate of not 017800 placement heifers): For increased less than 60 mg nor more rate of weight gain.. than 200 mg of lasalocid per head per day.. (xix) 300...... Pasture cattle (slaughter, stocker, Feed continuously on a free- 067949 feeder cattle, and dairy and beef re- choice basis at a rate of not placement heifers): for increased less than 60 mg nor more rate of weight gain.. than 200 mg of lasalocid per head per day.. (xx)–(xxviii) [Re- served].

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

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Ingredient Percent International feed No.

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

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

Ingredient Percent International feed No.

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

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

Ingredient Percent International feed No.

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

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Ingredient Percent International feed No.

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

(ii) Amount. 1,088 grams per ton. (d) Special considerations. (1) Federal (iii) Indications for use. Pasture cattle law restricts medicated feed containing (slaughter, stocker, feeder cattle, and this veterinary feed directive (VFD) dairy and beef replacement heifers): drug to use by or on the order of a li- For increased rate of weight gain. In- censed veterinarian. See § 558.6 for addi- takes of lasalocid in excess of 200 mg/ tional requirements. head/day have not been shown to be (2) The expiration date of VFDs for more effective than 200 mg/head/day. lincomycin medicated feeds must not (iv) Limitations. Feed continuously on exceed 6 months from the date of a free-choice basis at a rate of 60 to 300 issuance. VFDs for lincomycin shall mg lasalocid per head per day. not be refilled. (v) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (3) Labeling of Type A medicated ar- (5) Lasalocid may also be used in ticles and Type B and Type C medi- combination with: cated feeds containing lincomycin (i) Chlortetracycline as in § 558.128. shall bear the following: (ii) Lincomycin as in § 558.325. (i) ‘‘CAUTION: Do not allow rabbits, (iii) Melengestrol as in § 558.342. hamsters, guinea pigs, horses, or (iv) Oxytetracycline as in § 558.450. ruminants access to feeds containing (v) Tylosin alone or in combination lincomycin. Ingestion by these species with melengestrol acetate as in may result in severe gastrointestinal § 558.625. effects.’’ (vi) Virginiamycin as in § 558.635. (ii) [Reserved] [41 FR 44382, Oct. 8, 1976] (4) Labeling of medicated feeds containing lincomycin intended for use in EDITORIAL NOTES: 1. For FEDERAL REGISTER citations affecting § 558.311, see the List of swine shall bear the following: CFR Sections Affected, which appears in the (i) ‘‘CAUTION: Occasionally, swine Finding Aids section of the printed volume fed lincomycin may within the first 2 and at www.govinfo.gov. days after the onset of treatment de- 2. At 79 FR 13545, Mar. 11, 2014, § 558.311 was velop diarrhea and/or swelling of the amended; however, the amendment could not anus. On rare occasions, some pigs may be incorporated because of the inaccurate amendatory instruction. show reddening of the skin and irri- table behavior. These conditions have § 558.325 Lincomycin. been self-correcting within 5 to 8 days (a) Specifications. Type A medicated without discontinuing the lincomycin articles containing 20 or 50 grams of treatment.’’ lincomycin (as lincomycin hydro- (ii) ‘‘CAUTION: The effects of linco- chloride) per pound. mycin on swine reproductive perform- (b) Sponsors. See No. 054771 in ance, pregnancy, and lactation have § 510.600(c) of this chapter. not been determined.’’ (c) Related tolerances. See § 556.360 of (e) Conditions of use—(1) Chickens— this chapter.

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

(i) 2 ...... Broilers: For the control of necrot- Feed as the sole ration. Not for 054771 ic enteritis caused or com- use in layers, breeders, or tur- plicated by Clostridium spp. or keys. other organisms susceptible to lincomycin. (ii) [Re- served] (iii) 2 ...... Clopidol, 113.5 ...... Broiler chickens: For the control of Feed as the sole ration to broiler 054771 necrotic enteritis caused or chickens. Do not feed to chick- complicated by Clostridium spp. ens over 16 weeks of age. Not or other organisms susceptible for use in laying hens, breeding to lincomycin, and as an aid in chickens, or turkeys. Do not the prevention of cecal and in- allow rabbits, hamsters, guinea testinal coccidiosis caused by pigs, horses, or ruminants ac- Eimeria tenella, E. necatrix, E. cess to feeds containing linco- acervulina, E. maxima, E. mycin. Ingestion by these spe- brunetti, and E. mivati. cies may result in severe gastrointestinal effects. Clopidol as provided by No. 016592 in § 510.600 of this chapter. (iv) 2 ...... Decoquinate, 27.2 .... Broiler chickens: For the control of Feed as the sole ration. Do not 054771 necrotic enteritis caused or use in feeds containing ben- complicated by Clostridium spp. tonite. Not for use in laying or other organisms susceptible hens, breeding chickens, or tur- to lincomycin; and for the pre- keys. Do not allow rabbits, ham- vention of coccidiosis caused by sters, guinea pigs, horses, or Eimeria tenella, E. necatrix, E. ruminants access to feeds con- acervulina, E. brunetti, E. mivati, taining lincomycin. Ingestion by and E. maxima. these species may result in severe gastrointestinal effects. Decoquinate as provided by No. 054771 in § 510.600 of this chapter. (v) 2 ...... Halofuginone 2.72 .... Broiler chickens: For the control of Feed continuously as sole ration. 016592 necrotic enteritis caused or Withdraw 4 days before slaugh- complicated by Clostridium spp. ter. Do not feed to laying chick- or other organisms susceptible ens or waterfowl. Halofuginone to lincomycin; and the preven- hydrobromide as provided by tion of coccidiosis caused by No. 016592 in § 510.600 of this Eimeria tenella, E. necatrix, E. chapter. acervulina, E. brunetti, E. mivati, and E. maxima. (vi) 2 ...... Lasalocid, 68 to 113 Broiler chickens: For the control of Feed as the sole ration. Type C 054771 necrotic enteritis caused or feed must be used within 4 complicated by Clostridium spp. weeks of manufacture. Not for or other organisms susceptible use in laying hens, breeding to lincomycin, and for the pre- chickens, or turkeys. Do not vention of coccidiosis caused by allow rabbits, hamsters, guinea Eimeria tenella, E. necatrix, E. pigs, horses, or ruminants ac- acervulina, E. brunetti, E. mivati, cess to feeds containing linco- and E maxima. mycin. Ingestion by these species may result in severe gastrointestinal effects. Lasalocid as provided by No. 054771 in § 510.600 of this chapter.

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

(vii) 2 ...... Monensin, 90 to 110 Broiler chickens: For the control of Feed as the sole ration. Must be 054771 necrotic enteritis caused or thoroughly mixed in feeds be- complicated by Clostridium spp. fore use. Do not feed undiluted. or other organisms susceptible Not for use in laying hens, to lincomycin, and as an aid the breeding chickens, or turkeys. prevention of coccidiosis Do not allow horses, or other caused by Eimeria necatrix, E. equines, mature turkeys, or tenella, E. acervulina, E. guinea fowl access to feed con- brunetti, E. mivati, and E. maxi- taining monensin. Ingestion of ma. monensin by horses and guinea fowl has been fatal. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Monensin as provided by No. 058198 in § 510.600 of this chapter. (viii) 2 ...... Robenidine hydro- Broiler chickens: For the control of Feed as the sole ration. Do not 054771 chloride, 30. necrotic enteritis caused or use in feeds containing ben- complicated by Clostridium spp. tonite. Do not feed to laying or other organisms susceptible hens producing eggs for human to lincomycin, and as an aid in consumption. Not for use in lay- the prevention of coccidiosis ing hens, breeding chickens, or caused by Eimeria mivati, E. turkeys. Do not allow rabbits, brunetti, E. tenella, E. hamsters, guinea pigs, horses, acervulina, E. maxima, and E. or ruminants access to feeds necatrix. containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Withdraw 5 days prior to slaughter. Type C feed containing robenidine hydrochloride must be fed within 50 days from the date of manufacture. Robenidine hydrochloride as provided by No. 054771 in § 510.600 of this chapter. (ix) 2 ...... Salinomycin sodium, Broiler chickens: For the control of Feed as the sole ration to broiler 054771 40 to 60. necrotic enteritis caused or chickens. Do not feed to laying complicated by Clostridium spp. hens producing eggs for human or other organisms susceptible consumption. Not approved for to lincomycin, and for the pre- use with pellet binders. May be vention of coccidiosis caused by fatal if accidentally fed to adult Eimeria tenella, E. necatrix, E. turkeys or horses. Not for use in acervulina, E maxima, E. laying hens, breeding chickens, brunetti, and E. mivati. or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Salinomycin sodium as provided by No. 054771 in § 510.600 of this chapter. (x) 2 ...... Zoalene, 113.5 ...... Broiler chickens: For the control of Feed as the sole ration from the 054771 necrotic enteritis caused or time chicks are placed in floor complicated by Clostridium spp. pens until slaughtered for meat. or other organisms susceptible Not for use in laying hens, to lincomycin; and for the pre- breeding chickens, or turkeys. vention and control of coccidi- Do not allow rabbits, hamsters, osis. guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Zoalene as provided by No. 054771 in § 510.600 of this chapter.

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(2) Swine—

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

(i) 40...... For control of swine dysentery Feed as sole ration. For use in 054771 and the control of porcine prolif- swine on premises with a his- erative enteropathies (ileitis) tory of swine dysentery but caused by Lawsonia where symptoms have not yet intracellularis. occurred, or following use of lincomycin at 100 grams (g)/ton for the treatment of swine dysentery and the control of porcine proliferative enteropathies (ileitis). (ii) 40 ...... Fenbendazole, 10 to For control of swine dysentery in Feed as sole ration to provide a 000061 80. animals on premises with a his- total dose of 9 mg tory of swine dysentery, but fenbendazole/kg of body weight where symptoms have not yet within 3 to 12 days. Do not feed occurred; and for the removal to swine that weigh more than of: Adult stage lungworms 250 pounds. Lincomycin as pro- (Metastrongylus apri and M. vided by No. 054771; pudendotectus); adult and lar- fenbendazole as provided by vae (L3, 4 stages—liver, lung, No. 000061 in § 510.600(c) of intestinal forms) large this chapter. roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus). (iii) 40 ...... Pyrantel, 96 ...... For control of swine dysentery on Feed as the sole ration. Not to be 066104 premises with a history of swine fed to swine that weigh more dysentery, but where symptoms than 250 pounds. Withdraw 6 have not yet occurred; as an days prior to slaughter. Linco- aid in the prevention of migra- mycin as provided by No. tion and establishment of large 054771; pyrantel as provided by roundworm (Ascaris suum) in- No. 066104 in § 510.600(c) of fections; and as an aid in the this chapter. prevention of establishment of nodular worm (Oesophagostomum spp.) infections. (iv) 40 ...... Pyrantel, 96 ...... For the treatment and/or control of Feed for 3 days as the sole ration. 066104 swine dysentery; for removal Not to be fed to swine that and control of large roundworm weigh more than 250 pounds. (Ascaris suum) infections. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. (v) 40 or 100 Pyrantel, 96 ...... For the treatment and/or control of For treatment of swine dysentery, 066104 swine dysentery; as an aid in feed 100 grams of lincomycin the prevention of migration and and 96 grams of pyrantel tar- establishment of large trate per ton of complete feed roundworm (Ascaris suum) infor 3 weeks or until clinical fections; and as an aid in the signs of the disease disappear, prevention of establishment of following with 40 grams of linco- nodular worm mycin and 96 grams of pyrantel (Oesophagostomum spp.) infec- tartrate per ton of complete feed tions. as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter.

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

(vi) 40 ...... Pyrantel, 800 ...... For the treatment and/or control of Feed as a single therapeutic treat- 066104 swine dysentery; for removal ment at a rate of 1 lb of feed and control of large roundworm per 40 lb of body weight for ani- (Ascaris suum) and nodular mals up to 200 lb and 5 lb of worm (Oesophagostomum spp.) feed per head for animals over infections. 200 lb. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. See paragraph (d) of this section. Linco- mycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. (vii) 100 ...... For treatment of swine dysentery Feed as the sole ration for 3 054771 and the control of porcine prolif- weeks or until clinical signs of erative enteropathies (ileitis) the disease disappear. caused by Lawsonia intracellularis. (viii) 100 ...... Fenbendazole, 10 to For the treatment of swine dys- Feed as sole ration to provide a 000061 80. entery; and for the removal of: total dose of 9 mg Adult stage lungworms fenbendazole/kg of body weight (Metastrongylus apri and M. within 3 to 12 days. Do not feed pudendotectus); adult and lar- to swine that weigh more than vae (L3, 4 stages—liver, lung, 250 pounds. Do not use within intestinal forms) large 6 days of slaughter. Lincomycin roundworms (Ascaris suum); as provided by No. 054771; adult stage nodular worms fenbendazole as provided by (Oesophagostomum dentatum, No. 000061 in § 510.600(c) of O. quadrispinulatum); adult this chapter. stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus). (ix) 100 ...... Pyrantel, 96 ...... For the treatment of swine dys- Feed as the sole ration for 3 066104 entery; as an aid in the preven- weeks or until clinical signs of tion of migration and establish- the disease disappear. Not to ment of large roundworm be fed to swine that weigh more (Ascaris suum) infections; and than 250 pounds. Withdraw 6 as an aid in the prevention of days prior to slaughter. Linco- establishment of nodular worm mycin as provided by No. (Oesophagostomum spp.) infec- 054771; pyrantel as provided by tions. No. 066104 in § 510.600(c) of this chapter. (x) 100 ...... Pyrantel, 96 ...... For the treatment and/or control of Feed for 3 days as the sole ration. 066104 swine dysentery; for removal Not to be fed to swine that and control of large roundworm weigh more than 250 pounds. (Ascaris suum) infections. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. (xi) 100 ...... Pyrantel, 800 ...... For the treatment and/or control of Feed as a single therapeutic treat- 066104 swine dysentery; for removal ment. Not to be fed to swine and control of large roundworm that weigh more than 250 (Ascaris suum) and nodular pounds. Withdraw 24 hours worm (Oesophagostomum spp.) prior to slaughter. Lincomycin infections. as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. (xii) 100 to ...... For reduction in the severity of the Feed as sole ration for 21 days .... 054771 200. effects of respiratory disease associated with Mycoplasma hyopneumoniae.

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

(xiii) 200 ...... Fenbendazole, 10 to For reduction in the severity of Feed as sole ration to provide a 000061 80. swine mycoplasmal pneumonia total dose of 9 mg caused by Mycoplasma fenbendazole/kg of body weight hyopneumoniae; and for the re- within 3 to 12 days. Do not feed moval of: Adult stage to swine that weigh more than lungworms (Metastrongylus apri 250 pounds. Do not use within and M. pudendotectus); adult 6 days of slaughter. Lincomycin and larvae (L3, 4 stages—liver, as provided by No. 054771; lung, intestinal forms) large fenbendazole as provided by roundworms (Ascaris suum); No. 000061 in § 510.600(c) of adult stage nodular worms this chapter. (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus). (xiv) 200 ...... Pyrantel, 96 ...... For reduction in the severity of Feed as the sole ration for 21 054771 swine mycoplasmal pneumonia days. Not for use in swine that caused by Mycoplasma weigh more than 250 pounds. hyopneumoniae; and as an aid Withdraw 6 days before slaugh- in the prevention of migration ter. Lincomycin as provided by and establishment of large No. 054771; pyrantel as pro- roundworm (Ascaris suum) in- vided by No. 066104 in fections; aid in the prevention of § 510.600(c) of this chapter. establishment of nodular worm (Oesophagostomum spp.) infections.

[81 FR 95005, Dec. 27, 2016, as amended at 82 FR 12170, Mar. 1, 2017; 82 FR 21691, May 10, 2017; 83 FR 13637, Mar. 30, 2018; 83 FR 14588, Apr. 5, 2018; 83 FR 48947, Sept. 28, 2018; 83 FR 64741, Dec. 18, 2018; 84 FR 8976, Mar. 13, 2019; 84 FR 12501, Apr. 2, 2019; 84 FR 39185, Aug. 9, 2019]

§ 558.330 Lubabegron. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (a) Specifications. Each pound of Type (c) Related tolerances. See § 556.370 of A medicated article contains 4.54 this chapter. grams (10 grams per kilogram) of (d) Conditions of use. (1) It is used in lubabegron as lubabegron fumarate. cattle feed as follows:

Lubabegron fumarate in grams/ Combination in Indications for use Limitations Sponsor ton grams/ton

(i) 1.25 to 4.54 ...... Beef steers and heifers fed in con- Feed continuously as the sole ra- 058198 finement for slaughter: For re- tion to provide 13 to 90 mg duction of ammonia gas emis- lubabegron/head/day during sions per pound of live weight the last 14 to 91 days on feed. and hot carcass weight during A decrease in dry matter in- the last 14 to 91 days on feed. take may be noticed in some animals receiving lubabegron. Not approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed containing lubabegron.

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Lubabegron fumarate in grams/ Combination in Indications for use Limitations Sponsor ton grams/ton

(ii) 1.25 to 4.54 Monensin, 5 to 40 ... Beef steers and heifers fed in con- Feed continuously as the sole ra- 058198 finement for slaughter: For re- tion to provide 13 to 90 mg duction of ammonia gas emis- lubabegron/head/day and 50 to sions per pound of live weight 480 mg monensin/head/day and hot carcass weight and for during the last 14 to 91 days improved feed efficiency during on feed. No additional im- the last 14 to 91 days on feed. provement in feed efficiency has been shown from feeding monensin at levels greater than 30 g/ton (360 mg monensin/head/day. A decrease in dry matter intake may be noticed in some animals receiving lubabegron. Lubabegron has not been approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal.

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Lubabegron fumarate in grams/ Combination in Indications for use Limitations Sponsor ton grams/ton

(iii) 1.25 to 4.54 Monensin, 10 to 40 Beef steers and heifers fed in con- Feed continuously as the sole ra- 058198 finement for slaughter: For re- tion to provide 13 to 90 mg duction of ammonia gas emis- lubabegron/head/day and 0.14 sions per pound of live weight to 0.42 mg monensin/lb body and hot carcass weight; and for weight per day, depending prevention and control of coccidi- upon severity of coccidiosis osis due to Eimeria bovis and E. challenge, during the last 14 to zuernii during the last 14 to 91 91 days on feed. A decrease days on feed. in dry matter intake may be noticed in some animals receiving lubabegron. Lubabegron has not been approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal.

(2) Lubabegron may also be used in (c) Conditions of use—(1) Amount. 4.54 combination with: to 5.45 grams per ton (5 to 6 parts per (i) Tylosin as in § 558.625. million) (1 to 1.2 pounds per ton). (ii) [Reserved] (2) Indications for use. Broiler chickens: For prevention of coccidiosis [84 FR 12501, Apr. 2, 2019, as amended at 84 caused by Eimeria acervulina, E. tenella, FR 53311, Oct. 7, 2019] E. brunetti, E. maxima, E. necatrix, and § 558.340 Maduramicin. E. mivati. (3) Limitations. For broiler chickens (a) Approvals. Type A medicated arti- only. Feed continuously as sole ration. cles: 4.54 grams per pound to 054771 in § 510.600(c) of this chapter. (b) Tolerances. See § 556.375 of this chapter.

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

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

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

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

(iii) 0.25 to 0.5 .... Lasalocid, 10 to 30 .. Heifers fed in confinement for slaugh- Add at the rate of 0.5 to 2.0 lb/ 054771, ter: For increased rate of weight head/day a medicated feed 058198 gain, improved feed efficiency, and (liquid or dry) containing suppression of estrus (heat); and 0.125 to 1.0 mg melengestrol for control of coccidiosis caused by acetate/lb to a feed con- Eimeria bovis and Eimeria zuernii. taining 10 to 30 g of lasalocid per ton to provide 0.25 to 0.5 mg melengestrol acetate and 100 to 360 milligrams of lasalocid per head/day. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. (iv) 0.25 to 0.5 .... Monensin, 10 to 40 .. Heifers fed in confinement for slaugh- Add at the rate of 0.5 to 2 lb/ 016592, ter: For increased rate of weight head/day a medicated feed 054771, gain, improved feed efficiency, and (liquid or dry) containing 058198 suppression of estrus (heat); and 0.125 to 1 mg melengestrol for the prevention and control of acetate/lb to a feed con- coccidiosis due to Eimeria bovis taining 10 to 40 g of and E. zuernii. 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. See § 558.355(d). Monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter.

(2) Melengestrol may also be used in dogs not intended primarily for breed- combination with: ing purposes. (i) Oxytetracycline as in § 558.450. (3) Limitations. Administer daily at (ii) Ractopamine as in § 558.500. least 30 days before expected initiation (iii) Tylosin as in § 558.625. of heat and continue as long as desired, (iv) Zilpaterol as in § 558.665. but for not more than 12 months. Mibolerone should not be used in [42 FR 28535, June 3, 1977] bitches before first estrous period or in EDITORIAL NOTE: For FEDERAL REGISTER ci- purebred Bedlington terriers. It is not tations affecting § 558.342, see the List of CFR intended for animals being used pri- Sections Affected, which appears in the marily for breeding purposes. Use oral- Finding Aids section of the printed volume and at www.govinfo.gov. ly in adult female dogs only. Federal law restricts this drug to use by or on § 558.348 Mibolerone. the order of a licensed veterinarian. (a) Approvals. To No. 054771in [47 FR 6617, Feb. 16, 1982, as amended at 79 § 510.600(c) of this chapter for a canned FR 13545, Mar. 11, 2014] dog food, each 61⁄2 ounce can containing 30 or 60 micrograms of mibolerone. § 558.355 Monensin. (b) Conditions of use—(1) Amount. 30 (a) Specifications. Type A medicated micrograms for animals weighing up to articles containing 45, 60, 90.7, or 110 25 pounds; 60 micrograms for animals grams monensin, USP, per pound. weighing 26 to 50 pounds; 120 (b) Sponsors. See sponsors in micrograms for animals weighing 51 to § 510.600(c) of this chapter for use as in 100 pounds; 180 micrograms for animals paragraph (f) of this section. weighing over 100 pounds, or German (1) No. 058198 for use as in paragraph Shepherds or German Shepherd mix (f) of this section. weighing 30 to 80 pounds. (2) No. 016592 for use of a Type A (2) Indications for use. For the preven- medicated article containing 90.7 tion of estrus (heat) in adult female grams monensin, USP, per pound as in

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paragraphs (f)(3), (f)(4)(vi), and (f)(6) of paragraphs (d)(10)(i) and (d)(10)(ii) of this section. this section). (c) Related tolerances. See § 556.420 of (viii) A withdrawal period has not this chapter. 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 immediately rinse thoroughly with calving intervals in dairy cows fed water. monensin. Have a comprehensive and (6) All formulations containing ongoing nutritional, reproductive, and monensin shall bear the following cau- herd health program in place when tion statement: Do not allow horses or feeding monensin to dairy cows. other equines access to feed containing (x) Inadequate mixing (recirculation monensin. Ingestion of monensin by or agitation) of monensin liquid Type B horses has been fatal. or Type C medicated feeds has resulted (7) Type A medicated articles con- in increased monensin concentration taining monensin intended for use in which has been fatal to cattle and cattle and goats shall bear, in addition could be fatal to goats. to the caution statement in paragraph (8) Type A medicated articles con- (d)(6) of this section, the following taining monensin intended for use in statements: chickens, turkeys, and quail shall bear (i) Monensin medicated cattle and the following statements: goat feeds are safe for use in cattle and (i) Do not allow horses, other goats only. Consumption by unap- equines, mature turkeys, or guinea proved species may result in toxic re- fowl access to feed containing actions. monensin. Ingestion of monensin by (ii) Feeding undiluted or mixing er- horses and guinea fowl has been fatal. rors resulting in high concentrations of (ii) Must be thoroughly mixed in monensin has been fatal to cattle and feeds before use. could be fatal to goats. (iii) Must be thoroughly mixed in (iii) Do not feed undiluted. feeds before use. (iv) Do not feed to laying chickens. (iv) Do not feed undiluted. (v) Do not feed to chickens over 16 (v) Do not exceed the levels of weeks of age. monensin recommended in the feeding (vi) For replacement chickens in- directions, as reduced average daily tended for use as cage layers only. gains may result. (vii) Some strains of turkey coccidia (vi) Do not feed to lactating goats. may be monensin tolerant or resistant. (vii) If feed refusals containing Monensin may interfere with develop- monensin are fed to other groups of ment of immunity to turkey coccidi- cattle, the concentration of monensin osis. in the refusals and amount of refusals (viii) In the absence of coccidiosis in fed should be taken into consideration broiler chickens the use of monensin to prevent monensin overdosing (see with no withdrawal period may limit

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feed intake resulting in reduced weight this section. Paragraph (d)(7)(vii) of gain. this section does not apply to free- (9) Type B feeds containing monensin choice Type C medicated feeds as de- shall bear the statements specified in fined in § 510.455 of this chapter. the following paragraphs of this sec- (iii) Goats: See paragraphs (d)(6), tion when intended for use in: (d)(7)(i), (d)(7)(v), and (d)(7)(vi) of this (i) Cattle (as described in paragraphs section. (f)(3)(i) through (f)(3)(xii) of this section): (iv) Chickens: See paragraphs (d)(8)(i), See paragraphs (d)(6), (d)(7)(i) through (d)(8)(iv), (d)(8)(v), (d)(8)(vi), and (d)(7)(v), (d)(7)(vii), and (d)(7)(viii) of (d)(8)(viii) of this section. this section. (v) Turkeys: See paragraphs (d)(8)(i) (ii) Dairy cows (as described in para- and (d)(8)(vii) of this section. graphs (f)(3)(xiii) and (f)(3)(xiv) of this (vi) Quail: See paragraph (d)(8)(i) of section): See paragraphs (d)(6), (d)(7)(i) this section. through (d)(7)(iv), (d)(7)(vii), (d)(7)(viii), (11) Type B and Type C liquid feeds and (d)(7)(ix) of this section. requiring recirculation or agitation (iii) Goats: See paragraphs (d)(6) and that contain monensin and are in- (d)(7)(i) through (d)(7)(vi) of this sec- tended for use in cattle (including tion. dairy cows) and goats shall bear the (iv) Chickens: See paragraphs (d)(8)(i) caution statement specified in para- through (d)(8)(vi), and (d)(8)(viii) of this graph (d)(7)(x) of this section. section. (12) Mixing directions for liquid feeds (v) Turkeys: See paragraphs (d)(8)(i), requiring recirculation or agitation: (d)(8)(ii), (d)(8)(iii), and (d)(8)(vii) of (i) For liquid feeds stored in recircu- this section. lating tank systems: Recirculate im- (vi) Quail: See paragraphs (d)(8)(i), mediately prior to use for not less than (d)(8)(ii), and (d)(8)(iii) of this section. 10 minutes, moving not less than 1 per- (10) Type C feeds containing cent of the tank contents per minute monensin shall bear the statements from the bottom of the tank to the top. specified in the following paragraphs of Recirculate daily as described even this section when intended for use in: when not used. (i) Cattle (as described in paragraphs (ii) For liquid feeds stored in me- (f)(3)(i) through (f)(3)(xii) of this section): chanical, air, or other agitation-type See paragraphs (d)(6), (d)(7)(i), (d)(7)(v), tank systems: Agitate immediately (d)(7)(vii), and (d)(7)(viii) of this sec- prior to use for not less than 10 min- tion. Paragraph (d)(7)(vii) of this sec- utes, creating a turbulence at the bot- tion does not apply to free-choice Type tom of the tank that is visible at the C medicated feeds as defined in § 510.455 top. Agitate daily as described even of this chapter. when not used. (ii) Dairy cows (as described in para- (e) [Reserved] graphs (f)(3)(xiii) and (f)(3)(xiv) of this (f) Conditions of use. It is used as fol- section): See paragraphs (d)(6), (d)(7)(i), lows: (d)(7)(vii), (d)(7)(viii), and (d)(7)(ix) of (1) Chickens—

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

(i) 90 to ...... Broiler chickens: As an aid in the Feed continuously as the sole ration. 058198 110. prevention of coccidiosis caused In the absence of coccidiosis, the by E. necatrix, E. tenella, E. use of monensin with no with- acervulina, E. brunetti, E. mivati, drawal period may limit feed intake and E. maxima. resulting in reduced weight gain. Do not feed to laying chickens. (ii) 90 to ...... Replacement chickens intended for Feed continuously as the sole ration. 058198 110. use as cage layers: As an aid in Do not feed to chickens over 16 the prevention of coccidiosis weeks of age. Do not feed to lay- caused by E. necatrix, E. tenella, ing chickens. E. acervulina, E. brunetti, E. mivati, and E. maxima.

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

(iii) 90 to Bacitracin Broiler chickens: As an aid in the Feed continuously as sole ration. In 054771 110. methylenedisali- prevention of coccidiosis caused the absence of coccidiosis, the cylate, 4 to 50. by E. necatrix, E. tenella, E. use of monensin with no with- acervulina, E. brunetti, E. mivati, drawal period may limit feed intake and E. maxima, and for improved resulting in reduced weight gain. feed efficiency. Do not feed to laying chickens. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter. (iv) 90 to Bacitracin Replacement chickens intended for Feed continuously as sole ration. Do 054771 110. methylenedisali- use as cage layers: As an aid in not feed to chickens over 16 cylate, 4 to 50. the prevention of coccidiosis weeks of age. Do not feed to lay- caused by E. necatrix, E. tenella, ing chickens. Monensin sodium E. acervulina, E. brunetti, E. provided by No. 058198, bacitracin mivati, and E. maxima, and for in- methylenedisalicylate provided by creased rate of weight gain and No. 054771 in § 510.600(c) of this improved feed efficiency. chapter. (v) 90 to Bacitracin Broiler chickens: As an aid in the Feed continuously as sole ration. In 058198 110. methylenedisali- prevention of coccidiosis caused the absence of coccidiosis, the cylate, 5 to 25. by E. necatrix, E. tenella, E. use of monensin with no with- acervulina, E. brunetti, E. mivati, drawal period may limit feed intake and E. maxima, and for increased resulting in reduced weight gain. rate of weight gain and improved Do not feed to laying chickens. feed efficiency. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter. (vi) 90 to Bacitracin Broiler and replacement chickens in- Feed continuously as sole ration. Do 054771 110. methylenedisali- tended for use as cage layers: As not feed to chickens over 16 cylate, 50. an aid in the prevention of coccidi- weeks of age. Do not feed to lay- osis caused by E. necatrix, E. ing chickens. Monensin sodium tenella, E. acervulina, E. brunetti, provided by No. 058198, bacitracin E. mivati, and E. maxima, and for methylenedisalicylate provided by improved feed efficiency, and as No. 054771 in § 510.600(c) of this an aid in the prevention of necrotic chapter. enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. (vii) 90 to Bacitracin zinc, 4 Broiler chickens: As an aid in the Feed continuously as sole ration. In 054771 110. to 50. prevention of coccidiosis caused the absence of coccidiosis, the by E. necatrix, E. tenella, E. use of monensin with no with- acervulina, E. brunetti, E. mivati, drawal period may limit feed intake and E. maxima, and for increased resulting in reduced weight gain. rate of weight gain and improved Do not feed to laying chickens. feed efficiency. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter. (viii) 90 to Bacitracin zinc, 10 Broiler chickens: As an aid in the Feed continuously as sole ration. In 058198 110. prevention of coccidiosis caused the absence of coccidiosis, the by E. necatrix, E. tenella, E. use of monensin with no with- acervulina, E. brunetti, E. mivati, drawal period may limit feed intake and E. maxima, and for increased resulting in reduced weight gain. rate of weight gain and improved Do not feed to laying chickens. feed efficiency. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter. (ix) 90 to Bacitracin zinc, 10 Broiler chickens: As an aid in the Feed continuously as sole ration. In 058198 110. to 30. prevention of coccidiosis caused the absence of coccidiosis, the by E. necatrix, E. tenella, E. use of monensin with no with- acervulina, E. brunetti, E. mivati, drawal period may limit feed intake and E. maxima, and for improved resulting in reduced weight gain. feed efficiency. Do not feed to laying chickens. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter. (x) 90 to Bambermycins, 1 Broiler chickens: As an aid in the Feed continuously as sole ration. Do 016592, 110. to 2. prevention of coccidiosis caused not feed to laying chickens. 058198 by E. necatrix, E. tenella, E. Bambermycins provided by No. acervulina, E. brunetti, E. mivati, 016592 in § 510.600(c) of this and E. maxima, and for increased chapter. rate of weight gain and improved feed efficiency.

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(2) Turkeys—

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

(i) 54 to 90 ...... Growing turkeys: For the prevention For growing turkeys only. Feed con- 058198 of coccidiosis caused by E. tinuously as sole ration. Some adenoeides, E. meleagrimitis, and strains of turkey coccidia may be E. gallopavonis. monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. (ii) 54 to Bacitracin Growing turkeys: For the prevention For growing turkeys only. Feed con- 058198 90. methylenedisali- of coccidiosis caused by E. tinuously as sole ration. Some cylate, 4 to 50. adenoeides, E. meleagrimitis, and strains of turkey coccidia may be E. gallopavonis, and for increased monensin tolerant or resistant. rate of weight gain and improved Monensin may interfere with devel- feed efficiency. opment of immunity to turkey coccidiosis. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. (iii) 54 to Bacitracin Growing turkeys: For the prevention For growing turkeys only. Feed con- 058198 90. methylenedisali- of coccidiosis caused by E. tinuously as sole ration. Some cylate, 200. adenoeides, E. meleagrimitis, and strains of turkey coccidia may be E. gallopavonis, and as an aid in monensin tolerant or resistant. the control of transmissible enter- Monensin may interfere with devel- itis complicated by organisms sus- opment of immunity to turkey coc- ceptible to bacitracin cidiosis. Do not allow horses, other methylenedisalicylate. equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. (iv) 54 to Bambermycins, 1 Growing turkeys: For the prevention For growing turkeys only. Feed con- 058198 90. to 2. of coccidiosis in turkeys caused by tinuously as sole ration. Some E. adenoeides, E. meleagrimitis, strains of turkey coccidia may be and E. gallopavonis, and for im- monensin tolerant or resistant. proved feed efficiency. Monensin may interfere with development of immunity to turkey coccidiosis. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. (v) 54 to Bambermycins, 2 Growing turkeys: For the prevention For growing turkeys only. Feed con- 058198 90. of coccidiosis caused by E. tinuously as sole ration. Some adenoeides, E. meleagrimitis, and strains of turkey coccidia may be E. gallopavonis, and for increased monensin tolerant or resistant. rate of weight gain and improved Monensin may interfere with devel- feed efficiency. opment of immunity to turkey coccidiosis. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter.

(3) Cattle—

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Monensin in grams/ton Indications for use Limitations Sponsor

(i) 5 to 40 .... Cattle fed in confinement for slaughter: For im- Feed continuously in complete feed at a rate 058198 proved feed efficiency. of 50 to 480 milligrams of monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day). (ii) 10 to 40 Cattle fed in confinement for slaughter: For Feed at a rate of 0.14 to 0.42 milligram per 058198 prevention and control of coccidiosis due to pound of body weight per day, depending E. bovis and E. zuernii. upon the severity of challenge, up to maximum of 480 milligrams per head per day. (iii) 10 to Calves excluding veal calves: For prevention Feed at a rate of 0.14 to 1.0 milligram 058198 200. and control of coccidiosis due to E. bovis monensin per pound of body weight per and E. zuernii. day, depending upon the severity of challenge, up to maximum of 200 milligrams per head per day. (iv) 11 to 22 Dairy cows: For increased milk production effi- Feed continuously to dry and lactating dairy 058198 ciency (production of marketable solids-cor- cows in a total mixed ration (‘‘complete rected milk per unit of feed intake). feed’’). See special labeling considerations in paragraph (d) of this section. (v) 11 to 400 Dairy cows: For increased milk production effi- Feed continuously to dry and lactating dairy 058198 ciency (production of marketable solids-cor- cows in a component feeding system (in- rected milk per unit of feed intake). cluding top dress). The Type C medicated feed must be fed in a minimum of 1 lb of feed to provide 185 to 660 mg/head/day monensin to lactating cows or 115 to 410 mg/head/day monensin to dry cows. See special labeling considerations in paragraph (d) of this section. (vi) 15 to Growing cattle on pasture or in dry lot (stocker For increased rate of weight gain, feed at a 058198 400. and feeder cattle and dairy and beef re- rate of 50 to 200 milligrams monensin per placement heifers): For increased rate of head per day in not less than 1 pound of weight gain, and for prevention and control feed or, after the 5th day, feed at a rate of of coccidiosis due to E. bovis and E. zuernii. 400 milligrams per head per day every other day in not less than 2 pounds of feed. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending on severity of challenge, up to 200 milligrams per head per day. During first 5 days of feeding, cattle should receive no more than 100 milligrams per day in not less than 1 pound of feed. (vii) 25 to For improved feed efficiency, and for preven- Feed to mature reproducing beef cows. Feed 058198 400. tion and control of coccidiosis due to E. as supplemental feed, either hand-fed in a bovis and E. zuernii. minimum of 1 pound of feed or mixed in a total ration. For improved feed efficiency, feed continuously at a rate of 50 to 200 milligrams monensin per head per day. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending upon severity of challenge, up to a maximum of 200 milligrams per head per day. During first 5 days of feeding, cattle should receive no more than 100 milligrams per head per day.

(4) Free-choice cattle feeds—

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Monensin amount Indications for use Limitations Sponsor

(i) 150 milli- Pasture cattle (slaughter, stocker, feeder, and Provide 50 to 200 milligrams of monensin 058198 grams per dairy and beef replacement heifers): For in- (0.34 to 1.33 pounds of block) per head per pound of creased rate of weight gain, and for preven- day, at least 1 block per 10 to 12 head of protein- tion and control of coccidiosis caused by E. cattle. Roughage must be available at all mineral bovis and E. zuernii in pasture cattle which times. Do not allow animals access to other block may require supplemental feed. protein blocks, salt or mineral, while being (0.033%). fed this product. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section. (ii) 175 milli- Pasture cattle (slaughter, stocker, and feeder): Provide 40 to 200 milligrams of monensin 017800 grams per For increased rate of weight gain. (0.25 to 1.13 pounds or 4 to 18 ounces of pound of block) per head per day, at least 1 block per protein- 4 head of cattle. Do not allow cattle access mineral to salt or mineral while being fed this prod- block uct. Ingestion by cattle of monensin at levels (0.038%). of 600 milligrams per head per day and higher has been fatal. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section. (iii) 400 milli- Pasture cattle (slaughter, stocker, feeder, and Provide 80 to 200 milligrams of monensin (0.2 067949 grams per dairy and beef replacement heifers): For in- to 0.5 pounds of block) per head per day, at pound of creased rate of weight gain. least 1 block per 5 head of cattle. Feed protein- blocks continuously. Do not feed salt or min- mineral erals containing salt. The effectiveness of block this block in cull cows and bulls has not (0.088%). been established. See paragraph (d)(10)(i) of this section. (iv) 400 mg Pasture cattle (slaughter, stocker, feeder, and Provide 50 to 200 mg of monensin (2 to 8 086113 per pound dairy and beef replacement heifers): For in- ounces of block) per head per day, at least of block creased rate of weight gain. 1 block per 5 head of cattle. Feed blocks (0.088%). continuously. Do not feed salt or mineral supplements in addition to the blocks. Inges- tion by cattle of monensin at levels of 600 mg per head per day and higher has been fatal. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section. (v) In free- Growing cattle on pasture or in dry lot (stocker During the first 5 days of feeding, cattle should 058198 choice and feeder cattle and dairy and beef re- receive no more than 100 milligrams per Type C placement heifers): For increased rate of day. Do not feed additional salt or minerals. medicated weight gain; for prevention and control of Do not mix with grain or other feeds. feeds to coccidiosis due to E. bovis and E. zuernii. Monensin is toxic to cattle when consumed provide 50 at higher than approved levels. Stressed to 200 mg and/or feed- and/or water-deprived cattle per head should be adapted to the pasture and to per day. unmedicated supplement before using the monensin medicated supplement. The product’s effectiveness in cull cows and bulls has not been established. See paragraph (d) of this section for other required label warnings. (vi) 1,620 Growing cattle on pasture or in dry lot (stocker Feed at a rate of 50 to 200 milligrams per 058198 grams per and feeder cattle and dairy and beef re- head per day. During the first 5 days of ton of min- placement heifers): For increased rate of feeding, cattle should receive no more than eral gran- weight gain, and for prevention and control 100 milligrams per day. Do not feed addi- ules as of coccidiosis due to E. bovis and E. zuernii. tional salt or minerals. Do not mix with grain specified or other feeds. Monensin is toxic to cattle in para- when consumed at higher than approved graph. levels. Stressed and/or feed- and/or water- (f)(4)(vi)(A) deprived cattle should be adapted to the of this pasture and to unmedicated mineral supple- section. ment before using the monensin mineral supplement. The product’s effectiveness in cull cows and bulls has not been established.

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(A) Specifications. Use as free-choice Type C medicated feed formulated as mineral granules as follows:

International Ingredient Percent feed 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 Monensin Type A article, 90.7 grams per pound ...... 0.89 Antidusting oil ...... 1.0 1 Content of vitamin and trace mineral premixes 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) [Reserved] (5) Bobwhite quail—

Monensin in grams/ton Indications for use Limitations Sponsor

(i) 73 ...... Growing bobwhite quail: For the prevention of Feed continuously in complete feed at a rate 058198 coccidiosis caused by Eimeria dispersa and of 50 to 480 milligrams of monensin per E. lettyae. head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day). (ii) [Re- ...... served].

(6) Goats—

Monensin in grams/ton Indications for use Limitations Sponsor

(i) 20 ...... For the prevention of coccidiosis caused by Feed only to goats being fed in confinement. 058198 Eimeria crandallis, E. christenseni, and E. Do not feed to lactating goats. See para- ninakohlyakimovae. graph (d)(11) of this section for provisions for monensin liquid Type C goat feeds. (ii) [Re- ...... served].

(7) Monensin may also be used in (xii) Zilpaterol alone or in combina- combination with: tion as in § 558.665. (i) Avilamycin as in § 558.68. [40 FR 13959, Mar. 27, 1975] (ii) Chlortetracycline as in § 558.128. (iii) Decoquinate as in § 558.195. EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 558.355, see the List of CFR (iv) Lubabegron as in § 558.330. Sections Affected, which appears in the (v) Lincomycin as in § 558.325. Finding Aids section of the printed volume (vi) Melengestrol acetate as in and at www.govinfo.gov. § 558.342. (vii) Oxytetracycline as in § 558.450. § 558.360 Morantel. (viii) Ractopamine alone or in com- (a) Specifications. Each pound of Type bination as in § 558.500. A medicated article contains 88 grams (ix) Tilmicosin as in § 558.618. morantel tartrate. (x) Tylosin as in § 558.625. (b) Sponsor. See No. 066104 in (xi) Virginiamycin as in § 558.635. § 510.600(c) of this chapter.

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(c) Related tolerances. See § 556.425 of (2) Consult your veterinarian before this chapter. using in severely debilitated animals (d) Special considerations. (1) Do not and for assistance in the diagnosis, use in Type B or Type C medicated treatment, and control of parasitism. feeds containing bentonite. (e) Conditions of use. It is used in feed as follows:

Morantel tartrate in grams/ton Indications for use Limitations Sponsor

(1) 0.44 to 4.4 grams Cattle: For removal and control of mature Feed as a single therapeutic treatment at 066104 of morantel tartrate gastrointestinal nematode infections of 0.44 gram of morantel tartrate per 100 per pound of feed. cattle including stomach worms pounds of body weight. Fresh water (Haemonchus spp., Ostertagia spp., should be available at all times. When Trichostrongylus spp.), worms of the medicated feed is consumed, resume small intestine (Cooperia spp., normal feeding. Conditions of constant Trichostrongylus spp., Nematodirus worm exposure may require retreatment spp.), and worms of the large intestine in 2 to 4 weeks. Do not treat cattle with- (Oesophagostomum radiatum). in 14 days of slaughter. (2) 0.44 to 4.4 grams Goats: For removal and control of mature Feed as a single therapeutic treatment at 066104 of morantel tartrate gastrointestinal nematode infections of 0.44 gram of morantel tartrate per 100 per pound of feed. goats including Haemonchus contortus, pounds of body weight. Fresh water Ostertagia (Teladorsagia) circumcincta, should be available at all times. When and Trichostrongylus axei. medicated feed is consumed, resume normal feeding. Conditions of constant worm exposure may require retreatment in 2 to 4 weeks. Do not treat goats within 30 days of slaughter.

[84 FR 39185, Aug. 9, 2019] (c) Tolerances. See § 556.428 of this chapter. § 558.363 Narasin. (d) Special considerations. An expira- (a) Specifications. Type A medicated tion date of 2 months (8 weeks) is re- articles containing 36, 45, 54, 72, and 90 quired for narasin Type C medicated grams narasin per pound. swine feeds. (b) Sponsor. See No. 058198 in (e) Conditions of use. It is used as fol- § 510.600(c) of this chapter. lows: (1) Chickens—

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

(i) 54 to 90...... Broiler chickens: For prevention of For broiler chickens only. Feed 058198 coccidiosis caused by Eimeria continuously as sole ration. necatrix, E. tenella, E. acervulina, Do not allow adult turkeys, E. brunetti, E. mivati, and E. maxi- horses, or other equines ac- ma. cess to narasin formulations. Ingestion of narasin by these species has been fatal. (ii) 54 to 72 ...... Bacitracin Broiler chickens: For prevention of For broiler chickens only. Feed 054771 methylenedisalicyl- coccidiosis caused by Eimeria continuously as sole ration. ate, 10 to 50. necatrix, E. tenella, E. acervulina, Do not feed to laying hens. E. brunetti, E. mivati, and E. maxi- Do not allow adult turkeys, ma, and for increased rate of horses, or other equines ac- weight gain and improved feed effi- cess to narasin formulations. ciency. Ingestion of narasin by these species has been fatal. Baci- tracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter.

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

(iii) 54 to 72 ...... Bacitracin zinc, 4 to Broiler chickens: For prevention of For broiler chickens only. Feed 054771 50. coccidiosis caused by Eimeria continuously as sole ration. necatrix, E. tenella, E. acervulina, Do not allow adult turkeys, E. brunetti, E. mivati, and E. maxi- horses, or other equines ac- ma, and for increased rate of cess to narasin formulations. weight gain and improved feed effi- Ingestion of narasin by these ciency. species has been fatal. Baci- tracin zinc as provided by No. 054771 in § 510.600(c) of this chapter. (iv) 54 to 72 ...... Bambermycins, 1 to Broiler chickens: For prevention of For broiler chickens only. Feed 016592 2. coccidiosis caused by Eimeria continuously as sole ration. necatrix, E. tenella, E. acervulina, Do not allow adult turkeys, E. brunetti, E. mivati, and E. maxi- horses, or other equines ac- ma, and for increased rate of cess to narasin formulations. weight gain and improved feed effi- Ingestion of narasin by these ciency. species has been fatal. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter.

(2) Swine—

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

(i) 13.6 to 27.2 ...... Growing-finishing swine: For in- Feed continuously for at least 4 058198 creased rate of weight gain when weeks to swine during the fed for at least 4 weeks. growing-finishing period as the sole ration. No increased benefit in rate of weight gain has been shown when narasin concentrations in the diet are greater than 13.6 g/ ton. Effectiveness has not been demonstrated when fed for durations less than 4 weeks. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Not approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Swine being fed with narasin should not have access to feeds containing pleuromutilins (e.g., tiamulin) as adverse reactions may occur. If signs of toxicity occur, discontinue use.

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

(ii) 18.1 to 27.2 ...... Growing-finishing swine: For in- Feed continuously for at least 4 058198 creased rate of weight gain and im- weeks to swine during the proved feed efficiency when fed for growing-finishing period as at least 4 weeks. the sole ration. No increased benefit in rate of weight gain has been shown when narasin concentrations in the diet are greater than 13.6 g/ ton. Effectiveness has not been demonstrated when fed for durations less than 4 weeks. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Not approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Swine being fed with narasin should not have access to feeds containing pleuromutilins (e.g., tiamulin) as adverse reactions may occur. If signs of toxicity occur, discontinue use.

(3) Narasin single-ingredient Type A containing 36 grams narasin and 36 medicated articles may also be used in grams nicarbazin per pound. combination with: (b) Sponsor. See No. 058198 in (i) Avilamycin as in § 558.68. § 510.600(c) of this chapter. (ii) [Reserved] (c) Tolerances. See §§ 556.428 and [83 FR 64741, Dec. 18, 2018] 556.445 of this chapter. (d) Conditions of use. It is used as fol- § 558.364 Narasin and nicarbazin. lows: (a) Specifications. A fixed-ratio, com- (1) Chickens— bination drug Type A medicated article

Narasin and nicarbazin Combination in Indications for use Limitations Sponsor grams/ton grams/ton

(i) 27 to 45 of ...... Broiler chickens: For prevention of Feed continuously as the sole 058198 each drug. coccidiosis caused by Eimeria ration. Do not feed to laying tenella, E. necatrix, E. acervulina, hens. Do not allow adult tur- E. maxima, E. brunetti, and E. keys, horses, or other mivati. equines access to formulations containing narasin. In- gestion of narasin by these species has been fatal. The two drugs can be combined only at a 1:1 ratio for the 27 to 45 grams per ton range. Only granular nicarbazin as provided by No. 058198 in § 510.600(c) of this chapter may be used in the combination.

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Narasin and nicarbazin Combination in Indications for use Limitations Sponsor grams/ton grams/ton

(ii) 27 to 45 of Bacitracin Broiler chickens: For prevention of Feed continuously as sole ra- 058198 each drug. methylenedisalicyl- coccidiosis caused by Eimeria tion. Do not feed to laying ate, 4 to 50. tenella, E. necatrix, E. acervulina, hens. Withdraw 5 days be- E. maxima, E. brunetti, and E. fore slaughter. Do not allow mivati, and for increased rate of turkeys, horses, or other weight gain and improved feed effi- equines access to formula- ciency. tions containing narasin. In- gestion of narasin by these species has been fatal. Baci- tracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. (iii) 27 to 45 of Bacitracin Broiler chickens: For prevention of Feed continuously as sole ra- 054771 each drug. methylenedisalicyl- coccidiosis caused by Eimeria tion. Withdraw 5 days before ate, 50. tenella, E. necatrix, E. acervulina, slaughter. Do not feed to lay- E. maxima, E. brunetti, and E. ing hens. Do not allow tur- mivati, and as an aid in the preven- keys, horses, or other tion of necrotic enteritis caused or equines access to formula- complicated by Clostridium spp. or tions containing narasin. In- other organisms susceptible to bac- gestion of narasin by these itracin. species has been fatal. Baci- tracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. (iv) 27 to 45 of Bacitracin Broiler chickens: For prevention of To control necrotic enteritis, 054771 each drug. methylenedisalicyl- coccidiosis caused by Eimeria start medication at first clin- ate, 100 to 200. tenella, E. necatrix, E. acervulina, ical signs of disease; vary E. maxima, E. brunetti, and E. dosage based on the severity mivati, and as an aid in the control of infection; administer con- of 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. In- gestion of narasin by these species has been fatal. Baci- tracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. (v) 27 to 45 of Bambermycins, 1 to Broiler chickens: As an aid in pre- Feed continuously as sole ra- 058198 each drug. 2. 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, 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 feed to laying hens. Withdraw 5 days before slaughter. Do not allow turkeys, horses, or other equines access to formulations containing narasin. In- gestion of narasin by these species has been fatal. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter.

(2) Narasin and nicarbazin fixed- (ii) [Reserved] ratio, combination drug Type A medi- [83 FR 64742, Dec. 18, 2018, as amended at 84 cated articles may also be used in com- FR 8981, Mar. 13, 2019] bination with: (i) Avilamycin as in § 558.68.

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§ 558.365 Neomycin sulfate. this veterinary feed directive (VFD) drug to use by or on the order of a li- (a) Specifications. Type A medicated censed veterinarian. See § 558.6 for addi- article containing 325 grams neomycin tional requirements. sulfate per pound. (2) The expiration date of VFDs for (b) Sponsor. See No. 054771 in neomycin medicated feeds must not ex- § 510.600(c) of this chapter. ceed 6 months from the date of (c) Related tolerances. See § 556.430 of issuance. VFDs for neomycin shall not this chapter. be refilled. (d) Special considerations. (1) Federal (e) Conditions of use. Neomycin sul- law restricts medicated feed containing fate is used as follows:

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; 81 FR 95009, Dec. 27, 2016. Redesignated at 83 FR 64742, Dec. 18, 2018]

§ 558.366 Nicarbazin. for use as in paragraph (d) of this section. (a) Specifications. Type A medicated (c) Related tolerances. See § 556.445 of articles containing 25 percent this chapter. nicarbazin. (d) Conditions of use. It is used as fol- (b) Sponsors. See Nos. 058198, 060728, lows: and 066104 in § 510.600(c) of this chapter (1) Chickens—

Combination Nicarbazin in in grams per Indications for use Limitations Spon- grams per ton ton sor

(i) 90.8 to 181.6 ...... Broiler chickens: As an Feed continuously as sole ration 066104 aid in preventing out- from time chicks are placed breaks of cecal on litter until past the time (Eimeria tenella) and when coccidiosis is ordinarily intestinal (E. a hazard. Do not use as a acervulina, E. maxi- treatment for outbreaks of ma, E. necatrix, and coccidiosis. Do not use in E. brunetti) coccidi- flushing mashes. Do not feed osis. to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton.

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Combination Nicarbazin in in grams per Indications for use Limitations Spon- grams per ton ton sor

(ii) 90.8 to 181.6 .... Bacitracin Broiler chickens: As an Feed continuously as sole ration 054771 methylenedis- aid in preventing out- from time chicks are placed alicylate, 4 to breaks of cecal on litter until past the time 50. (Eimeria tenella) and when coccidiosis is ordinarily intestinal (E. a hazard. Do not use as a acervulina, E. maxi- treatment for outbreaks of ma, E. necatrix, and coccidiosis. Do not use in E. brunetti) coccidi- flushing mashes. Do not feed osis, and for in- to laying hens. Withdraw 4 creased rate of weight days before slaughter for use gain and improved levels at or below 113.5 g/ton. feed efficiency. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Nicarbazin as provided by No. 066104; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. (iii) 90.8 to 181.6 .... Bacitracin Broiler chickens; As an Feed continuously as sole ration 066104 methylenedis- aid in preventing out- from time chicks are placed alicylate, 30. breaks of cecal on litter until past the time (Eimeria tenella) and when coccidiosis is ordinarily intestinal (E. a hazard. Do not use as a acervulina, E. maxi- treatment for coccidiosis. Do ma, E. necatrix, and not use in flushing mashes. E. brunetti) coccidi- Do not feed to laying hens. osis, and for in- Withdraw 4 days before creased rate of weight slaughter for use levels at or gain and improved below 113.5 g/ton. Withdraw feed efficiency. 5 days before slaughter for use levels above 113.5 g/ton. Nicarbazin as provided by No. 066104; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. (iv) 90.8 to 181.6 ... Bacitracin Broiler chickens: As an Feed continuously as sole ration 054771 methylenedis- aid in preventing out- from time chicks are placed alicylate 50. breaks of cecal on litter until past the time (Eimeria tenella) and when coccidiosis is ordinarily intestinal (E. a hazard. Do not use as a acervulina, E. maxi- treatment for outbreaks of ma, E. necatrix, and coccidiosis. Do not use in E. brunetti) coccidi- flushing mashes. Do not feed osis, and as an aid in to laying hens. Withdraw 4 the prevention of ne- days before slaughter for use crotic enteritis caused levels at or below 113.5 g/ton. or complicated by Withdraw 5 days before Clostridium spp. or slaughter for use levels above other organisms sus- 113.5 g/ton. Nicarbazin as ceptible to bacitracin. provided by No. 066104; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter.

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Combination Nicarbazin in in grams per Indications for use Limitations Spon- grams per ton ton sor

(v) 113.5 ...... Chickens: As an aid in Feed continuously as sole ration 058198 preventing outbreaks from time chicks are placed 060728 of cecal (Eimeria on litter until past the time tenella) and intestinal when coccidiosis is ordinarily (E. acervulina, E. a hazard. Do not use as a maxima, E. necatrix, treatment for coccidiosis. Do and E. brunetti) coc- not use in flushing mashes. cidiosis. Do not feed to laying hens. Withdraw 4 days before slaughter. (vi) 113.5 ...... Bacitracin Broiler chickens; aid in Feed continuously as sole ration 060728 methylenedis- preventing outbreaks from time chicks are placed alicylate, 30. of cecal (Eimeria on litter until past the time tenella) and intestinal when coccidiosis is ordinarily (E. acervulina, E. a hazard. Do not use as a maxima, E. necatrix, treatment for coccidiosis. Do and E. brunetti) coc- not use in flushing mashes. cidiosis, and for in- Do not feed to laying hens. creased rate of weight Withdraw 4 days before gain and improved slaughter. Nicarbazin as pro- feed efficiency. vided by No. 066104; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. (vii) 113.5 ...... Bacitracin zinc, Broiler chickens; aid in For broiler chickens only. Feed 054771 4 to 50. preventing outbreaks continuously as sole ration 066104 of cecal (Eimeria from time chicks are placed tenella) and intestinal on litter until past the time (E. acervulina, E. when coccidiosis is ordinarily maxima, E. necatrix, a hazard. Do not use in flush- and E. brunetti) coc- ing mashes. Do not feed to cidiosis, and for in- laying hens. Withdraw 4 days creased rate of weight before slaughter. Nicarbazin gain and improved as provided by No. 066104, feed efficiency. bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter. (viii) 113.5 ...... Bambermycins, Broiler chickens: As an Feed continuously as sole ration 016592 1 to 2. aid in preventing out- from time chicks are placed breaks of cecal on litter until past the time (Eimeria tenella) and when coccidiosis is ordinarily intestinal (E. a hazard; do not use as a acervulina, E. maxi- treatment for coccidiosis. Do ma, E. necatrix, and not use in flushing mashes. E. brunetti) coccidi- Do not feed to laying hens. osis, and for in- Withdraw 4 days before creased rate of weight slaughter. Nicarbazin as pro- gain and improved vided by No. 066104; feed efficiency. bambermycins as provided by No. 016592 in § 510.600(c) of this chapter.

(2) [Reserved] (b) Sponsor. See No. 054771 in [83 FR 64743, Dec. 18, 2018] § 510.600(c) of this chapter. (c) Related tolerances. See § 556.460 of § 558.415 Novobiocin. this chapter. (a) Specifications. Type A medicated (d) Conditions of use. It is used in ani- article containing 25 grams of mal feeds as follows: novobiocin activity per pound. (1) Chickens—

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Novobiocin amount Indications for use Limitations Sponsor

(i) To provide 6 to 7 milli- Chickens: As an aid in the treatment of Administer feed which contains not less 054771 grams per pound (mg/lb) breast blisters associated with staphy- than 200 grams of novobiocin activity of body weight per day. lococcal infections susceptible to per ton of feed as the sole ration for 5 novobiocin. to 7 days. Not for laying chickens. Withdraw 4 days before slaughter. (ii) To provide 10 to 14 Chickens: For the treatment of staphy- Administer feed which contains not less 054771 mg/lb of body weight per lococcal synovitis and generalized than 350 grams of novobiocin activity day. staphylococcal infections susceptible per ton of feed as the sole ration for 5 to novobiocin. to 7 days. Not for laying chickens. Withdraw 4 days before slaughter.

(2) Turkeys—

Novobiocin amount Indications for use Limitations Sponsor

(i) To provide 4 to 5 mg/lb Turkeys: As an aid in the treatment of Administer feed which contains not less 054771 of body weight per day. breast blisters associated with staphy- than 200 grams of novobiocin activity lococcal infections susceptible to per ton of feed as the sole ration for 5 novobiocin. to 7 days. Not for laying turkeys. With- draw 4 days before slaughter. (ii) To provide 5 to 8 mg/lb Turkeys: As an aid in the control of re- Administer feed which contains not less 054771 of body weight per day. curring outbreaks of fowl cholera than 200 grams of novobiocin activity caused by strains of Pasteurella per ton of feed as the sole ration for 5 multocida susceptible to novobiocin to 7 days. Not for laying turkeys. With- following initial treatment with 7 to 8 draw 4 days before slaughter. mg/lb of body weight per day. (iii) To provide 7 to 8 mg/lb Turkeys: For the treatment of staphy- Administer feed which contains not less 054771 of body weight per day. lococcal synovitis and generalized than 350 grams of novobiocin activity staphylococcal infections susceptible per ton of feed as the sole ration for 5 to novobiocin; and treatment of acute to 7 days. Not for laying turkeys. With- outbreaks of fowl cholera caused by draw 4 days before slaughter. strains of Pasteurella multocida susceptible to novobiocin.

(3) Minor species—

Novobiocin amount Indications for use Limitations Sponsor

(i) 350 grams per ton. Ducks: For the control of infectious sero- Administer as the sole ration for 5 to 7 054771 sitis and fowl cholera in ducks caused days. Continue medication for 14 days by Pasteurella anatipestifer and P. if necessary. Repeat if reinfection oc- multocida, susceptible to novobiocin. curs. Discontinue use at least 3 days before slaughter. Not for use in laying ducks. (ii) To provide 20 mg/lb of Mink: For the treatment of generalized Administer feed which contains not less 054771 body weight per day. infections, abscesses, or urinary infec- than 200 grams of novobiocin activity tions caused by staphylococcal or per ton of feed as the sole ration for 7 other novobiocin sensitive organisms. days.

[40 FR 13959, Mar. 27, 1975, as amended at 45 (d) Conditions of use. It is used for FR 42263, June 24, 1980; 51 FR 7399, Mar. 3, chickens and turkeys as follows: 1986; 52 FR 36402, Sept. 29, 1987; 79 FR 13545, (1) Amount. 50 grams per ton. Mar. 11, 2014; 84 FR 12501, Apr. 2, 2019] (i) Indications for use. Chickens and § 558.430 Nystatin. turkeys; aid in control of crop mycosis and mycotic diarrhea (Candida (a) Specifications. Type A medicated albicans). article containing 20 grams of nystatin (ii) Limitations. Growing and laying activity per pound. chickens; growing turkeys. (b) Sponsor. See No. 054771 in (2) Amount. 100 grams per ton. § 510.600(c) of this chapter. (i) Indications for use. Chickens and (c) Related tolerances. See § 556.470 of turkeys; treatment of crop mycosis and this chapter. mycotic diarrhea (Candida albicans).

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(ii) Limitations. Growing and laying (1) No. 066104: Type A medicated arti- chickens; growing turkeys; to be fed cles as in paragraph (a)(1) of this sec- for 7 to 10 days. tion. [41 FR 11002, Mar. 15, 1976, as amended at 51 (2) No. 069254: Type A medicated arti- FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; cles as in paragraph (a)(2) of this sec- 53 FR 40729, Oct. 18, 1988; 55 FR 8461, Mar. 8, tion. 1990; 57 FR 8578, Mar. 11, 1992; 79 FR 13545, (c) Related tolerances. See § 556.500 of Mar. 11, 2014] this chapter. § 558.450 Oxytetracycline. (d) Special considerations. (1) Federal law restricts medicated feed containing (a) Specifications. Each pound of Type A medicated article contains: this veterinary feed directive (VFD) (1) Oxytetracycline (from oxytetra- drug to use by or on the order of a li- cycline quaternary salt) equivalent to censed veterinarian. See § 558.6 for addi- 50 or 100 grams oxytetracycline hydro- tional requirements. chloride; or oxytetracycline (from oxy- (2) The expiration date of VFDs for tetracycline dihydrate base) equivalent oxytetracycline medicated feeds must to 10, 30, 50, 100, or 200 grams oxytetra- not exceed 6 months from the date of cycline hydrochloride. issuance. VFDs for oxytetracycline (2) Oxytetracycline (from oxytetra- shall not be refilled. cycline dihydrate base) equivalent to (3) In accordance with § 558.5, labeling 50, 100, or 200 grams oxytetracycline shall bear the statement: ‘‘For use in hydrochloride; or 100 grams oxytetra- dry animal feed only. Not for use in liq- cycline hydrochloride. uid feed supplements.’’ (b) Sponsors. See sponsors in (e) Conditions of use—(1) Chickens— § 510.600(c) of this chapter as follows:

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

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

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

(iv) 400 g/ton...... Robenidine, 30 ...... Broiler chickens: As an aid in Feed continuously for 7 to 14 066104 the prevention of coccidiosis days. Do not feed to chickens caused by Eimeria necatrix, E. producing eggs for human tenella, E. acervulina, E. consumption. Do not use in brunetti, E. mivati, and E. feed containing less than maxima; and for the control of 0.55% dietary calcium. Use in chronic respiratory disease such low calcium feeds may (CRD) and air sac infection result in violative residues. caused by Mycoplasma Withdraw 5 days before gallisepticum and Escherichia slaughter. Oxytetracycline as coli susceptible to oxytetra- provided by No. 066104; cycline. robenidine as provided by No. 054771 in § 510.600(c) of this chapter. (v) 500 g/ton ...... Chickens: For reduction of mor- Feed continuously for 5 days. 066104 tality due to air sacculitis (air Do not feed to chickens pro- 069254 sac infection) caused by E. ducing eggs for human con- coli susceptible to oxytetra- sumption. Do not use in feed cycline. containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 24 hours before slaughter. (vi) 500 g/ton ...... Monensin, 90 to 100 Broiler chickens: As an aid in Feed for 5 days as the sole ra- 066104 the prevention of coccidiosis tion. Treat at first clinical signs caused by Eimeria necatrix, E. of the disease. Do not feed to tenella, E. acervulina, E. laying chickens. Do not feed brunetti, E. mivati, and E. to chickens over 16 weeks of maxima; and as an aid in the age. Do not use in feed con- reduction of mortality due to taining less than 0.55% die- air-sacculitis (air sac infection) tary calcium. Use in such low caused by Escherichia coli calcium feeds may result in sensitive to oxytetracycline. violative residues. Withdraw 72 hours before slaughter. See § 558.355(d) of this chapter. Oxytetracycline as provided by No. 066104; monensin as provided by No. 058198 in § 510.600(c) of this chapter. (vii) 500 g/ton ...... Salinomycin, 40 to Chickens: For the prevention of Feed for 5 days as the sole ra- 066104 60. coccidiosis caused by Eimeria tion. Treat at first clinical signs 016592 necatrix, E. tenella, E. of the disease. Do not feed to acervulina, E. brunetti, E. laying chickens. Do not use in mivati, and E. maxima; and as feed containing less than an aid in the reduction of mor- 0.55% dietary calcium. Use in tality due to air-sacculitis (air such low calcium feeds may sac infection) caused by E. result in violative residues. coli sensitive to oxytetra- Withdraw 24 hours before cycline. slaughter. Oxytetracycline as provided by No. 066104; salinomycin as provided by No. 016592 in § 510.600(c) of this chapter.

(2) Turkeys—

Oxytetracycline amount Indications for use Limitations Sponsor

(i) 100 g/ton...... Turkeys: For control of hexamitiasis Feed continuously for 7 to 14 days. Do 066104 caused by Hexamita meleagridis sus- not feed to turkeys producing eggs for 069254 ceptible to oxytetracycline. human consumption. Zero-day withdrawal period. (ii) 200 g/ton ...... Turkeys: For control of infectious synovitis Feed continuously for 7 to 14 days. Do 066104 caused by M. synoviae susceptible to not feed to turkeys producing eggs for 069254 oxytetracycline. human consumption. For No. 066104, withdraw 5 days before slaughter. For No. 069254, zero-day withdrawal period.

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Oxytetracycline amount Indications for use Limitations Sponsor

(iii) 25 mg/lb of body Turkeys: For control of complicating bac- Feed continuously for 7 to 14 days. Do 066104 weight daily. terial organisms associated with not feed to turkeys producing eggs for 069254 bluecomb (transmissible enteritis; human consumption. For No. 066104, coronaviral enteritis) susceptible to oxy- withdraw 5 days before slaughter. For tetracycline. No. 069254, zero-day withdrawal period.

(3) Swine—

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

(i) 10 mg/lb of ...... 1. Swine: For treatment of bac- Feed continuously for 7 to 14 066104 body weight terial enteritis caused by days. 069254 daily. Escherichia coli and Sal- monella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline. 2. Breeding swine: For control Feed continuously for 14 days ... 066104 and treatment of leptospirosis 069254 (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline. (ii) 10 mg/lb of Carbadox, 10 to 25 Swine: For treatment of bacterial Feed continuously as the sole 066104 body weight enteritis caused by E. coli and ration for 7 to 14 days. Not for daily. Salmonella choleraesuis sus- use in pregnant swine or ceptible to oxytetracycline and swine intended for breeding treatment of bacterial pneu- purposes. Do not mix in feeds monia caused by Pasteurella containing bentonite. Do not multocida susceptible to oxy- feed to swine within 42 days tetracycline; and for increased of slaughter. Oxytetracycline rate of weight gain and im- and carbadox as provided by proved feed efficiency. No. 066104 in § 510.600(c) of this chapter.

(4) Cattle—

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

(i) 10 mg/lb of ...... 1. Calves and beef and nonlac- Feed continuously for 7 to 14 066104 body weight tating dairy cattle: For treat- days. For No. 069254, with- 069254 daily. ment of bacterial enteritis draw 5 days before slaughter. caused by Escherichia coli For No. 066104, zero-day and bacterial pneumonia withdrawal period. (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline. 2. Calves: For treatment of bac- Feed continuously for 7 to 14 066104 terial enteritis caused by E. days in milk replacer or starter 069254 coli susceptible to oxytetra- feed. This product is not ap- cycline. proved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. For No. 069254, withdraw 5 days before slaughter. For No. 066104, zero-day withdrawal period.

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

(ii) 75 mg/head/ ...... Growing cattle (over 400 lb): For Feed continuously ...... 066104 day. reduction of incidence of liver 069254 abscesses. (iii) 75 mg/head/ Lasalocid 25 to 30.. Heifers fed in confinement for Feed continuously to provide 054771 day. slaughter (over 400 lb): For 250 to 360 mg lasalocid and reduction of incidence of liver 75 mg of oxytetracycline per abscesses; and for increased head per day. Lasalocid as rate of weight gain and im- provided by No. 054771 in proved feed efficiency. § 510.600(c) of this chapter. (iv) 75 mg/head/ Melengestrol ace- Heifers fed in confinement for Feed continuously to provide 054771 day. tate, 0.25 to 2.0. slaughter (over 400 lb): For 0.25 to 0.5 mg of reduction of incidence of liver melengestrol acetate and 75 abscesses; and for increased mg of oxytetracycline per rate of weight gain, improved head per day. Melengestrol as feed efficiency, and suppres- provided by No. 054771 in sion of estrus (heat). § 510.600(c) of this chapter. (v) 0.5 to 2.0 g/ ...... Cattle: For prevention and treat- Feed 3 to 5 days before and 066104 head/day. ment of the early stages of after arrival in feedlots. 069254 shipping fever complex.

(5) Minor species—

Oxytetracycline amount Indications for use Limitations Sponsor

(i) 10 mg/lb of body Sheep: For treatment of bacterial enter- Feed continuously for 7 to 14 days; 066104 weight daily. itis caused by E. coli and bacterial withdraw 5 days before slaughter. 069254 pneumonia caused by P. multocida susceptible to oxytetracycline. (ii) 200 mg/colony ...... Honey bees: For control of American Remove at least 6 weeks prior to main 066104 foulbrood caused by Paenibacillus lar- honey flow. 069254 vae and European foulbrood caused by Streptococcus pluton susceptible to oxytetracycline. (iii) 2.5 to 3.75 g/100 lb of 1. Salmonids: For control of ulcer dis- Administer in mixed ration for 10 days; 066104 fish/day. ease caused by Haemophilus do not liberate fish or slaughter fish piscium, furunculosis caused by for food for 21 days following the last Aeromonas salmonicida, bacterial administration of medicated feed. hemorrhagic septicemia caused by A. hydrophila, and pseudomonas disease. 2. Catfish: For control of bacterial hem- Administer in mixed ration for 10 days; 066104 orrhagic septicemia caused by A. do not liberate fish or slaughter fish hydrophila and pseudomonas disease. for food for 21 days following the last administration of medicated feed; do not administer when water temperature is below 16.7 °C (62 °F). (iv) 3.75 g/100 lb of fish/ 3. Freshwater-reared salmonids weigh- Feed for 10 days. Immediate release is 066104 day.. ing up to 55 grams: For marking the permitted following the last feeding of skeletal tissue. medicated feed. (v) 11.35 g/100 lb of fish/ Pacific salmon not over 30 grams body Administer medicated feed as the sole 066104 day.. weight: For marking of skeletal tissue. ration for 4 consecutive days. Do not liberate for at least 7 days following last feeding of medicated feed. (vi) 1 g/lb of medicated Lobsters: For control of gaffkemia Administer as sole ration for 5 consecu- 066104 feed. caused by Aerococcus viridans. tive days; withdraw medicated feed 30 days before harvesting lobsters.

[81 FR 95009, Dec. 27, 2016, as amended at 82 FR 11512, Feb. 24, 2017; 83 FR 48948, Sept. 28, 2018; 84 FR 12502, Apr. 2, 2019]

§ 558.455 Oxytetracycline and neomy- oxytetracycline hydrochloride and 50 g/ cin. lb neomycin sulfate or oxytetracycline (a) Specifications. Type A medicated equivalent to 100 g/lb oxytetracycline articles containing oxytetracycline hydrochloride and 100 g/lb neomycin equivalent to 50 grams per pound (g/lb) sulfate.

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

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

(i) [Reserved].

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

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

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

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

Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors

(i) [Reserved].

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

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

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

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

Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors

(i) [Reserved].

(ii) To provide 10 mg/lb 1. Swine: For treatment of bacterial enteritis Feed continuously for 7 to 14 d; withdraw 5 066104 of body weight daily.. caused by E. coli and Salmonella d before slaughter.. 069254 choleraesuis and treatment of bacterial pneumonia caused by P. multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin..

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Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors

2. Breeding swine: For control and treat- Feed continuously for not more than 14 d; 066104 ment of leptospirosis (reducing the inci- withdraw 5 d before slaughter.. 069254 dence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline..

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

Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors

(i)–(ii) [Reserved].

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

(iv) [Reserved].

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

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

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

§ 558.464 Poloxalene. poloxalene or liquid Type A medicated articles containing 99.5 percent (a) Specifications. Dry Type A medi- poloxalene. cated articles containing 53 percent

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(b) Sponsor. See No. 054771 in pounds of body weight daily, cattle § 510.600(c) of this chapter. should be changed to a Type C feed (c) Related tolerances. See § 556.517 of containing 7.5 grams of poloxalene per this chapter. pound. (d) Conditions of use. (1) For preven- (3) Poloxalene liquid Type A article tion of legume (alfalfa, clover) and must be thoroughly blended and evenly wheat pasture bloat in cattle. distributed into a liquid Type C feed (2) Poloxalene dry Type A article and and offered to cattle in a covered liquid liquid Type A article must be thor- Type C feed feeder with lick wheels. oughly blended and evenly distributed The formula for the liquid Type C feed, in feed prior to use. This may be ac- on a weight/weight basis, is as follows: complished by adding the Type A arti- Ammonium polyphosphate 2.66 percent, cle to a small quantity of feed, mixing thoroughly, then adding this mixture phosphoric acid (75 percent) 3.37 per- to the remaining feed and again mixing cent, sulfuric acid 1.00 percent, water thoroughly. Dosage is 1 gram of 10.00 percent, and molasses sufficient poloxalene per 100 pounds of body to make 100.00 percent, vitamins A and weight daily and continued during ex- D and/or trace minerals may be added. posure to bloat producing conditions. If One free-turning lick wheel per 25 head bloating conditions are severe, the dose of cattle must be provided. is doubled. Treatment should be start- (4) The medicated liquid Type C feed ed 2 to 3 days before exposure to bloat- must be introduced at least 2 to 5 days producing conditions. Repeat dosage if before legume consumption to accus- animals are exposed to bloat-producing tom the cattle to the medicated liquid conditions more than 12 hours after the Type C feed and to lick wheel feedings. last treatment. Do not exceed the high- If the medicated liquid wheel Type C er dosage levels in any 24-hour period. feed feeding is interrupted, this 2- to 5- [40 FR 39857, Aug. 29, 1975, as amended at 51 day introductory feeding should be re- FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; peated. 56 FR 50654, Oct. 8, 1991; 60 FR 55660, Nov. 2, 1995; 79 FR 13545, Mar. 11, 2014; 84 FR 33001, [40 FR 13959, Mar. 27, 1975, as amended at 42 July 11, 2019] FR 21281, Apr. 26, 1977; 51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 56 FR 50654, § 558.465 Poloxalene free-choice liquid Oct. 8, 1991; 60 FR 55660, Nov. 2, 1995; 66 FR Type C feed. 47963, Sept. 17, 2001; 84 FR 33001, July 11, 2019] (a) Specifications. Type A medicated § 558.485 Pyrantel. articles containing 99.5 percent poloxalene. (a) Specifications. Type A medicated (b) Sponsor. See No. 066104 in articles containing 48 or 80 grams per § 510.600(c) of this chapter. pound pyrantel tartrate. (c) Related tolerances. See § 556.517 of (b) Sponsors. See sponsors in this chapter. § 510.600(c) of this chapter for uses as in (d) Conditions of use. (1) For control of paragraph (e) of this section. legume (alfalfa, clover) and wheat pas- (1) No. 066104: 48 and 80 grams per ture bloat in cattle, use 7.5 grams of pound for use as in paragraph (e)(1) of poloxalene per pound of liquid Type C this section. feed (1.65 percent weight/weight). Each (2) Nos. 017135 and 054771: 48 grams animal must consume 0.2 pound of per pound for use as in paragraph (e)(2) Type C feed per 100 pounds of body of this section. weight daily for adequate protection. (c) See § 556.560 of (2) For control of legume (alfalfa, clo- Related tolerances. ver) bloat in cattle grazing of prebloom this chapter. legumes, use 10.00 grams of poloxalene (d) Special considerations. (1) See per pound of liquid Type C feed (2.2 per- § 500.25 of this chapter. Consult a vet- cent weight/weight). Each animal must erinarian before using in severely de- consume 0.15 pound of Type C feed per bilitated animals. 100 pounds of body weight daily for ade- (2) Do not mix in Type B or Type C quate protection. If consumption ex- medicated feeds containing bentonite. ceeds 0.2 pound of Type C feed per 100 (e) Conditions of use—(1) Swine—

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Pyrantel grams/ton Indications for use Limitations Sponsor

(i) 96 ...... Swine: As an aid in the preven- Feed continuously as the sole ration in a 066104 tion of migration and estab- Type C feed. Withdraw 24 hours prior lishment of large roundworm to slaughter. (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum) infections. (ii) 96...... Swine: For the removal and Feed for 3 days as the sole ration in a 066104 control of large roundworm Type C feed. Withdraw 24 hours prior (Ascaris suum) infections. to slaughter. (iii) 800...... Swine: For the removal and Feed as the sole ration for a single 066104 control of large roundworm therapeutic treatment in Type C feed (Ascaris suum) and nodular at a rate of 1 lb of feed per 40 lb of worm (Oesophagostomum) in- body weight for animals up to 200 lb, fections. and 5 lb of feed per head for animals 200 lb or over. Withdraw 24 hours prior to slaughter.

(2) Horses—

Pyrantel grams/ton Indications for use Limitations Sponsor

To provide 1.2 Prevention of Strongylus Feed continuously. Administer either as 017135 mg/lb body vulgaris larval infections; con- a top-dress (not to exceed 20,000 g/ 054771 weight. trol of adult large strongyles ton) or mixed in the horse’s daily grain (S. vulgaris, and S. ration (not to exceed 1,200 g/ton) dur- edentatus), adult and 4th ing the time that the animal is at risk stage larvae small strongyles of exposure to internal parasites. Do (Cyathostomum spp., not use in horses intended for human Cylicocyclus spp., consumption. Consult your veteri- Cylicostephanus spp., narian before using in severely debili- Cylicodontophorus spp., tated animals and for assistance in Poteriostomum spp., and the diagnosis, treatment, and control Triodontophorus spp.), adult of parasitism. and 4th stage larvae pinworms (Oxyuris equi), and adult and 4th stage larvae ascarids (Parascaris equorum).

(3) Pyrantel may also be used in com- (c) Related tolerances. See § 556.570 of bination with: this chapter. (i) Carbadox as in § 558.115. (d) Special considerations. (1) Labeling (ii) Lincomycin as in § 558.325. of Type B and Type C feeds shall bear (iii) Tylosin as in § 558.625. the following: ‘‘Not for animals intended for breeding.’’ [83 FR 48948, Sept. 28, 2018, as amended at 83 (2) Labeling of Type B and Type C FR 64744, Dec. 18, 2018] swine feeds shall bear the following: § 558.500 Ractopamine. (i) ‘‘No increased benefit has been shown when ractopamine concentra- (a) Specifications. Type A medicated tions in the diet are greater than 4.5 g/ articles containing 9 or 45.4 grams of ton.’’ ractopamine hydrochloride per pound. (ii) ‘‘Ractopamine may increase the (b) Approvals. See Nos. 054771 and number of injured and/or fatigued pigs 058198 in § 510.600(c) of this chapter. during marketing.’’

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(3) Labeling of Type B and Type C at a pH of 4.5 to 7.5 or, if in combina- tom turkey feeds shall bear the fol- tion with monensin and/or tylosin, at a lowing: ‘‘No increased benefit has been pH of 4.5 to 6.0. Mixing directions for shown when ractopamine concentra- liquid Type B feeds requiring recircula- tions in the diet are greater than 4.6 g/ tion or agitation: Recirculate imme- ton.’’ diately prior to use for not less than 10 (4) Tylosin in combinations as minutes, moving not less than 1 per- tylosin phosphate. cent of the tank contents per minute (5) Ractopamine liquid Type B cattle from the bottom of the tank to the top. feeds may be manufactured from dry Recirculate daily as described even ractopamine Type A articles. The liq- when not used. uid Type B feeds must be maintained (e) Conditions of use—(1) Swine—

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

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

(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 Feed continuously as sole ra- 054771 slaughter: For increased rate of tion during the last 28 to 42 058198 weight gain and improved feed days on feed. efficiency during the last 28 to 42 days on feed. (ii) 8.2 to 24.6 ..... Monensin 10 to 40 Cattle fed in confinement for Feed continuously as sole ra- 016592 to provide 0.14 to slaughter: For increased rate of tion during the last 28 to 42 054771 0.42 mg weight gain and improved feed days on feed. See para- 058198 monensin/lb of efficiency during the last 28 to 42 graph § 558.355(d). body weight, de- days on feed, and for prevention Ractopamine as provided pending on se- and control of coccidiosis due to by No. 058198 or 054771; verity of coccidi- Eimeria bovis and E. zuernii. monensin as provided by osis challenge, No. 016592 or 058198 in up to 480 mg/ § 510.600(c) of this chapter. head/day.. (iii) 9.8 to 24.6...... Cattle fed in confinement for Feed continuously as sole ra- 054771 slaughter: For increased rate of tion during the last 28 to 42 058198 weight gain, improved feed effi- days on feed. Not for ani- ciency, and increased carcass mals intended for breeding. leanness during the last 28 to 42 days on feed. (iv) 9.8 to 24.6 .... Monensin 10 to 40 Cattle fed in confinement for Feed continuously as sole ra- 016592 to provide 0.14 to slaughter: For increased rate of tion during the last 28 to 42 054771 0.42 mg weight gain, improved feed effi- days on feed. Not for ani- 058198 monensin/lb of ciency, and increased carcass mals intended for breeding. body weight, de- leanness during the last 28 to 42 See paragraph pending on se- days on feed, and for prevention § 558.355(d). Ractopamine verity of coccidi- and control of coccidiosis due to as provided by No. 058198 osis challenge, Eimeria bovis and E. zuernii. or 054771; monensin as up to 480 mg/ provided by No. 016592 or head/day. 058198 in § 510.600(c) of this chapter.

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

(v) 9.8 to 24.6 .... Monensin 10 to 40 Heifers fed in confinement for Feed continuously as sole ra- 016592 to provide 0.14 to slaughter: For increased rate of tion during the last 28 to 42 054771 0.42 mg weight gain, improved feed effi- days on feed. Not for ani- 058198 monensin/lb of ciency, and increased carcass mals intended for breeding. body weight, de- leanness during the last 28 to 42 See §§ 558.342(d) and pending on se- days on feed, and for prevention 558.355(d). Melengestrol verity of coccidi- and control of coccidiosis due to acetate as provided by No. osis challenge, Eimeria bovis and E. zuernii, and 058198 or 054771; up to 480 mg/ for suppression of estrus (heat). monensin as provided by head/day, plus No. 016592 or 058198 in melengestrol ace- § 510.600(c) of this chapter. tate to provide 0.25 to 0.5 mg/ head/day. (vi) Not to exceed ...... Cattle fed in confinement for Top dress in a minimum of 1 054771 800; to provide slaughter: For increased rate of lb of medicated feed. 058198 70 to 400 mg/ weight gain and improved feed head/day. efficiency during the last 28 to 42 days on feed. (vii) Not to ex- Monensin 10 to 40 Cattle fed in confinement for Top dress ractopamine in a 016592 ceed 800; to to provide 0.14 to slaughter: For increased rate of minimum of 1 lb of medi- 054771 provide 70 to 0.42 mg weight gain and improved feed cated feed during the last 058198 400 mg/head/ monensin/lb of efficiency during the last 28 to 42 28 to 42 days on feed. Not day. body weight, de- days on feed, and for prevention for animals intended for pending on se- and control of coccidiosis due to breeding. See § 558.355(d). verity of coccidi- Eimeria bovis and E. zuernii. Ractopamine as provided osis challenge, by No. 058198 or 054771; up to 480 mg/ monensin as provided by head/day. No. 016592 or 058198 in § 510.600(c) of this chapter.

(3) Turkeys—

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

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

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(4) Ractopamine may also be used in § 558.515 Robenidine. combination with tylosin in as in (a) Approvals. Type A medicated arti- § 558.625. cles: 30 grams per pound to 054771 in [67 FR 71820, Dec. 3, 2002, as amended at 68 § 510.600(c) of this chapter. FR 54659, Sept. 18, 2003; 69 FR 12068, Mar. 15, (b) Special considerations. Type C feed 2004; 69 FR 51174, Aug. 18, 2004; 71 FR 31074, June 1, 2006; 71 FR 67301, Nov. 21, 2006; 72 FR containing robenidine hydrochloride 10358, Mar. 8, 2007; 72 FR 41619, July 31, 2007; must be fed within 50 days from the 72 FR 56897, Oct. 5, 2007; 72 FR 62571, Nov. 6, date of manufacture. Do not use in 2007; 72 FR 65667, Nov. 23, 2007; 72 FR 70777, Type B or Type C medicated feeds con- Dec. 13, 2007; 73 FR 72715, Dec. 1, 2008; 73 FR taining bentonite. 75323, Dec. 11, 2008; 74 FR 66914, Dec. 17, 2009; (c) Related tolerances. See § 556.580 of 75 FR 1276, Jan. 11, 2010; 75 FR 5888, Feb. 5, 2010; 75 FR 20917, Apr. 22, 2010; 75 FR 54018, this chapter. Sept. 3, 2010; 77 FR 31724, May 30, 2012; 78 FR (d) Conditions of use. It is used in feed 63872, Oct. 25, 2013; 79 FR 13546, Mar. 11, 2014; for chickens as follows: 79 FR 37621, July 2, 2014; 79 FR 44278, July 31, 2014; 79 FR 53136, Sept. 8, 2014; 80 FR 61298, Oct. 13, 2015; 81 FR 48703, July 26, 2016; 81 FR 95013, Dec. 27, 2016; 85 FR 18122, Apr. 1, 2020]

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

30 (0.0033 pct) ...... Broiler chickens: As an aid in the pre- Feed continuously as sole ra- 054771 vention of coccidiosis caused by E. tion. Do not feed to chickens mivati, E. brunetti, E. tenella, E. producing eggs for food. acervulina, E. maxima, and E. Withdraw 5 days prior to necatrix.. slaughter...... Bacitracin (as baci- For broiler and fryer chickens: As an Feed continuously as sole ra- 054771 tracin aid in the prevention of coccidiosis tion. Do not feed to laying methylenedisalicyl- caused by E. mivati, E. brunetti, E. chickens. Withdraw 5 days ate) 4 to 30. tenella, E. acervulina, E. maxima, prior to slaughter.. and E. necatrix. For increased rate of weight gain...... Bacitracin (as baci- For broiler and fryer chickens: As an Feed continuously as sole ra- 054771 tracin aid in the prevention of coccidiosis tion. Do not feed to laying methylenedisalicyl- caused by E. mivati, E. brunetti, E. chickens. Withdraw 5 days ate) 27 to 50. tenella, E. acervulina, E. maxima, prior to slaughter.. and E. necatrix. For improved feed efficiency...... Bacitracin (as baci- For broiler and fryer chickens: As an Feed continuously as sole ra- 054771 tracin aid in the prevention of necrotic en- tion. Do not feed to laying methylenedisalicyl- teritis caused or complicated by hens. Withdraw 5 days be- ate) 50. Clostridium spp. or other organisms fore slaughter.. susceptible to bacitracin...... Bacitracin (as baci- For broiler and fryer chickens: As an To control a necrotic enteritis 054771 tracin aid in the control of necrotic enter- outbreak, start medication at methylenedisalicyl- itis caused or complicated by Clos- first clinical signs of disease; ate) 100 to 200. tridium spp. or other organisms administer continuously for 5 susceptible to bacitracin.. to 7 days or as long as clinical signs persist, then reduce bacitracin methylenedisalicylate to prevention level (50 g/ton). Do not feed to laying hens. With- draw 5 days before slaughter...... Bacitracin (as baci- For broiler and fryer chickens: As an Feed continuously as sole ra- 054771 tracin zinc) 4 to 30. aid in the prevention of coccidiosis tion. Do not feed to laying 054771 caused by E. mivati, E. brunetti, E. chickens. Withdraw 5 days tenella, E. acervulina, E. maxima, prior to slaughter.. and E. necatrix. For increased rate of weight gain...... Bacitracin (as baci- For broiler and fryer chickens: As an Feed continuously as sole ra- 054771 tracin zinc) 27 to aid in the prevention of coccidiosis tion. Do not feed to laying 054771 50. caused by E. mivati, E. brunetti, E. chickens. Withdraw 5 days tenella, E. acervulina, E. maxima, prior to slaughter.. and E. necatrix. For improved feed efficiency..

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(e) Robenidine may also be used in § 558.550 Salinomycin. combination with: (a) Specifications. Type A medicated (1) Chlortetracycline as in § 558.128. articles containing 30 or 60 grams of (2) Lincomycin as in § 558.325. salinomycin activity per pound (as (3) Oxytetracycline as in § 558.450. salinomycin sodium biomass). [40 FR 13959, Mar. 27, 1975] (b) Sponsor. See No. 016592 in § 510.600(c) of this chapter. EDITORIAL NOTE: For FEDERAL REGISTER ci- (c) Related tolerances. See § 556.592 of tations affecting § 558.515, see the List of CFR this chapter. Sections Affected, which appears in the (d) Special considerations. Not ap- Finding Aids section of the printed volume proved for use with pellet binders. and at www.govinfo.gov. (e) Conditions of use. It is used as follows: (1) Chickens—

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

(i) 40 to 60 ...... Broiler, roaster, and replacement Feed continuously as sole ra- 016592 (breeder and layer) chickens: For tion. Do not feed to laying the prevention of coccidiosis hens producing eggs for caused by Eimeria tenella, E. human consumption. May be necatrix, E. acervulina, E. maxima, fatal if accidentally fed to E. brunetti, and E. mivati. adult turkeys or horses. (ii) 40 to 60 ...... Bacitracin Broiler, roaster, and replacement Feed continuously as sole ra- 016592 methylenedisalicyl- (breeder and layer) chickens: For tion. Do not feed to laying 054771 ate, 4 to 50. the prevention of coccidiosis chickens. May be fatal if fed caused by Eimeria tenella, E. to adult turkeys or horses. necatrix, E. acervulina, E. maxima, Salinomycin as provided by E. brunetti, and E. mivati, and for No. 016592; bacitracin increased rate of weight gain and methylenedisalicylate as pro- improved feed efficiency. vided by No. 054771 in § 510.600(c) of this chapter. (iii) 40 to 60 ...... Bacitracin Broiler chickens: For the prevention of Feed continuously as sole ra- 054771 methylenedisalicyl- coccidiosis caused by Eimeria tion. Do not feed to laying ate, 50. tenella, E. necatrix, E. acervulina, chickens. May be fatal if fed E. maxima, E. brunetti, and E. to adult turkeys or to horses. mivati, and as an aid in the preven- Salinomycin as provided by tion of necrotic enteritis caused or No. 016592; bacitracin complicated by Clostridium spp. or methylenedisalicylate as pro- other organisms susceptible to bac- vided by No. 054771 in itracin. § 510.600(c) in this chapter. (iv) 40 to 60 ...... Bacitracin Broiler chickens: For the prevention of Feed continuously as sole ra- 054771 methylenedisalicyl- coccidiosis caused by Eimeria tion. To control necrotic en- ate, 100 to 200. tenella, E. necatrix, E. acervulina, teritis, start medication at first E. maxima, E. brunetti, and E. clinical signs of disease; vary mivati, and as an aid in the control dosage based on the severity of necrotic enteritis caused or com- of infection; administer con- plicated by Clostridium spp. or tinuously for 5 to 7 days or other organisms susceptible to bac- as long as clinical signs per- itracin. sist, then reduce bacitracin to prevention level (50 grams per ton). Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) in this chapter. (v) 40 to 60 ...... Bacitracin zinc, 10 to Broiler chickens: For the prevention of Feed continuously as sole ra- 016592 50. coccidiosis caused by Eimeria tion. Not approved for use 054771 tenella, E. necatrix, E. acervulina, with pellet binders. Do not E. maxima, E. brunetti, and E. feed to layers. May be fatal if mivati, and for increased rate of accidentally fed to adult tur- weight gain. keys or horses. Bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter.

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

(vi) 40 to 60 ...... Bambermycins, 1 to Broiler chickens: For the prevention of Feed continuously as sole ra- 016592 3. coccidiosis caused by Eimeria tion. Do not feed to laying tenella, E. necatrix, E. acervulina, chickens. Not approved for E. maxima, E. brunetti, and E. use with pellet binders. May mivati, and for improved feed effi- be fatal if accidentally fed to ciency. adult turkeys or horses. Salinomycin and bambermycins as provided by No. 016592 in § 510.600(c) in this chapter.

(2) Game birds—

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

(i) 50 ...... Quail: For the prevention of coccidi- Feed continuously as sole ra- osis caused by E. dispersa and E. tion. Not approved for use lettyae. with pellet binders. Do not feed to laying hens producing eggs for human consumption. May be fatal if accidentally fed to adult turkeys or horses. (ii) [Reserved] ......

(3) Salinomycin may also be used in (1) 22.7 grams (g) per pound (lb) (50 g/ combination with: kilogram (kg)) semduramicin (as (i) Chlortetracycline as in § 558.128. semduramicin sodium). (ii) Lincomycin as in § 558.325. (2) 22.7 g/lb (50 g/kg) semduramicin (iii) Oxytetracycline as in § 558.450. (as semduramicin sodium biomass). (iv) Virginiamycin as in § 558.635. (b) Approvals. See No. 066104 in [48 FR 30616, July 5, 1983] § 510.600(c) of this chapter for use of EDITORIAL NOTE: For FEDERAL REGISTER ci- product described in paragraph (a)(1) as tations affecting § 558.550, see the List of CFR in paragraph (d) of this section; for use Sections Affected, which appears in the of product described in paragraph (a)(2) Finding Aids section of the printed volume as in paragraph (e) of this section. and at www.govinfo.gov. (c) Related tolerances. See § 556.597 of § 558.555 Semduramicin. this chapter. (d) Conditions of use in chickens. It is (a) Specifications. Type A medicated article containing: used in chicken feed as follows:

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

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

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

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

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

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

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

Sulfadimethoxine and ormetoprim Indications for use Limitations Sponsors grams/ton

(i) Sulfadimethoxine, Broiler chickens: As an aid in the pre- Feed as sole ration. Withdraw 5 days 054771 113.5; ormetoprim, 68.1. vention of coccidiosis caused by all before slaughter. Eimeria species known to be pathogenic to chickens, namely, E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and bacterial infections due to Heterakis gallinarum (infectious coryza), Esch- erichia coli (colibacillosis) and Pasteurella multocida (fowl cholera). (ii) Sulfadimethoxine, Replacement chickens: As an aid in the Feed as sole ration. Do not feed to 054771 113.5; ormetoprim, 68.1. prevention of coccidiosis caused by all chickens over 16 weeks (112 days) of Eimeria species known to be patho- age. Withdraw 5 days before slaugh- genic to chickens, namely, E. tenella, ter. E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and bacterial infections due to Heterakis gallinarum (infectious coryza), Esch- erichia coli (colibacillosis) and Pasteurella multocida (fowl cholera).

(2) Turkeys—

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Sulfadimethoxine and ormetoprim Indications for use Limitations Sponsors grams/ton

(i) Sulfadimethoxine, Turkeys: As an aid in the prevention of Do not feed to turkeys producing eggs 054771 56.75; ormetoprim, coccidiosis caused by all Eimeria spe- for food. Withdraw 5 days before 34.05. cies known to be pathogenic to tur- slaughter. keys, namely, E. adenoeides, E. gallopavonis, and E. meleagrimitis and bacterial infection due to Pasteurella multocida (fowl cholera). (ii) [Reserved]

(3) Minor species—

Sulfadimethoxine and ormetoprim amount Indications for use Limitations Sponsors

(i) Sulfadimethoxine, 227; Ducks, including breeding ducks: As an Feed as sole ration for 7 days. Medica- 054771 ormetoprim, 136.2 aid in the control of bacterial infections tion should be started at the first signs grams/ton of feed. due to Pasteurella multocida (fowl of infection. Do not feed to ducks pro- cholera). ducing eggs for food. Withdraw 5 days before slaughter. (ii) Sulfadimethoxine, 454; Ducks: As an aid in the control of bac- Feed as a sole ration for 7 days. Medi- ormetoprim, 272.4 terial infections due to Escherichia cation should be started at the first grams/ton of feed. coli, Riemerella anatipestifer, and se- signs of infection. Not for breeding vere challenge of Pasteurella ducks. Do not feed to ducks producing multocida (fowl cholera). eggs for food. Withdraw 5 days before slaughter. (iii) Sulfadimethoxine, Chukar partridges: For prevention of Feed continuously to young birds up to 8 054771 113.5; ormetoprim, 68.1 coccidiosis caused by Eimeria kofoidi weeks of age as sole ration. grams/ton of feed. and E. legionensis. (iv) 50 milligrams (mg) of Salmonids: For the control of furuncu- Administer for 5 consecutive days. With- 015331 active ingredients per losis in salmonids (trout and salmon) draw 42 days before release as stock- kilogram of body weight caused by Aeromonas salmonicida er fish or slaughter. per day. strains susceptible to sulfadimethoxine and ormetoprim combination. (v) 50 mg of active ingredi- Catfish: For control of enteric septicemia Administer for 5 consecutive days. With- 015331 ents per kilogram of of catfish caused by Edwardsiella draw 3 days before slaughter or re- body weight per day. ictaluri strains susceptible to lease as stocker fish. sulfadimethoxine and ormetoprim combination.

[40 FR 13959, Mar. 27, 1975, as amended at 42 (c) Related tolerances. See § 556.660 of FR 13550, Mar. 11, 1977; 49 FR 33442, Aug. 23, this chapter. 1984; 49 FR 46371, Nov. 26, 1984; 51 FR 7400, (d) Special considerations. (1) Federal Mar. 3, 1986; 51 FR 18884, May 23, 1986; 52 FR 2686, Jan. 26, 1987; 54 FR 1686, Jan. 17, 1989; 63 law restricts medicated feed containing FR 27846, May 21, 1998; 64 FR 26672, May 17, this veterinary feed directive (VFD) 1999; 64 FR 43910, Aug. 12, 1999; 66 FR 46707, drug to use by or on the order of a li- Sept. 7, 2001; 70 FR 52292, Sept. 2, 2005; 79 FR censed veterinarian. See § 558.6 for addi- 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, 2014; tional requirements. 81 FR 95013, Dec. 27, 2016; 83 FR 13637, Mar. 30, 2018; 84 FR 12502, Apr. 2, 2019] (2) The expiration date of VFDs for sulfamerazine medicated feeds must § 558.582 Sulfamerazine. not exceed 6 months from the date of (a) Specifications. Type A medicated issuance. VFDs for sulfamerazine shall articles containing 99 percent sulfa- not be refilled. merazine. (e) Conditions of use. It is used in fish (b) Sponsor. See No. 054771 in feed for as follows: § 510.600(c) of this chapter.

507

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

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

[81 FR 95013, Dec. 27, 2016]

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

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

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

508

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

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

(2) Turkeys—

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

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

509

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

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

(3) Rabbits—

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

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

[81 FR 95013, Dec. 27, 2016]

§ 558.600 Thiabendazole. (b) Sponsor. See No. 000010 in (a) Specifications. Dry Type A medi- § 510.600(c) of this chapter. cated articles containing 22, 44.1, 66.1, (c) Related tolerances. See § 556.730 of or 88.2 percent thiabendazole. The 66.1 this chapter. percent Type A medicated article is (d) Special considerations. Do not use solely for the manufacture of cane mo- in Type B or Type C medicated feed lasses liquid Type B feed, which is containing bentonite. mixed in dry feeds. The 88.2 percent (e) Conditions of use. It is used in feed Type A medicated article is used solely for animals as follows: for the manufacture of an aqueous slur- (1) Swine— ry for adding to a Type C dry cattle feed.

510

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Thiabendazole in grams/ton Indications for use Limitations Sponsor

(i) 45.4 to 908 (0.005 Swine: As an aid in the prevention of in- Administer continuously in feed containing 000010 to 0.1 percent). fections of large roundworms (genus 0.05 to 0.1 percent thiabendazole per Ascaris). ton for 2 weeks followed by feed containing 0.005 to 0.02 percent thiabendazole per ton for 8 to 14 weeks. Do not treat animals within 30 days of slaughter. (ii) [Reserved]

(2) Cattle—

Thiabendazole amount Indications for use Limitations Sponsor

(i) 3 grams per 100 For control of infections of gastrointestinal Use 3 grams per 100 lb. body weight at a 000010 lb. body weight. roundworms (Trichostrongylus spp., single dose; may repeat once in 2 to 3 Haemonchus spp., Ostertagia spp., weeks. Do not treat animals within 3 Nematodirus spp., Oesophagostomum days of slaughter. Milk taken from treat- radiatum). ed animals within 96 hours (8 milkings) after the latest treatment must not be used for food. (ii) 5 grams per 100 For control of severe infections of gastro- Use 5 grams per 100 lb. body weight at a 000010 lb. body weight. intestinal roundworms (Trichostrongylus single dose or divided into 3 equal spp., Haemonchus spp., Ostertagia doses, administered 1 dose each day, spp., Nematodirus spp., on succeeding days. May repeat once Oesophagostomum radiatum); control of in 2 to 3 weeks. Do not treat animals infections of Cooperia spp. within 3 days of slaughter. Milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food.

(3) Minor species—

Thiabendazole amount Indications for use Limitations Sponsor

(i) 2 grams per 100 Sheep and goats: For control of infections Use 2 grams per 100 lb. body weight at a 050604 lb. body weight. of gastrointestinal roundworms single dose. Do not treat animals within (Trichostrongylus spp., Haemonchus 30 days of slaughter. Milk taken from spp., Ostertagia spp., Cooperia spp.; treated animals within 96 hours (8 Nematodirus spp., Bunostomum spp., milkings) after the latest treatment must Strongyloides spp., Chabertia spp., and not be used for food. Oesophagostomum spp.); also active against ova and larvae passed by sheep from 3 hours to 3 days after the feed is consumed (good activity against ova and larvae of T. colubriformis and axei, Ostertagia spp., Nematodirus spp., Strongyloides spp.; less effective against those of Haemonchus contortus and Oesophagostomum spp.). (ii) 3 grams per 100 Goats: For control of severe infections of Use 3 grams per 100 lb. body weight at a 050604 lb. body weight. gastrointestinal roundworms single dose. Do not treat animals within (Trichostrongylus spp., Haemonchus 30 days of slaughter. Milk taken from spp., Ostertagia spp., Cooperia spp., treated animals within 96 hours (8 Nematodirus spp., Bunostomum spp., milkings) after the latest treatment must Strongyloides spp., Chabertia spp., and not be used for food. Oesophagostomum spp.). (iii) 454 grams per Pheasants: For the treatment of Feed continuously for 2 weeks (14 days). 050604 ton of feed. gapeworms (Syngamus trachea). Do not use treated pheasants for food for 21 days after last day of treatment. Fertility, hatchability, and other reproductive data are not available on use in breeding animals.

511

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[84 FR 39186, Aug. 9, 2019] polyether ionophores (e.g., lasalocid, monensin, narasin, salinomycin, or § 558.612 Tiamulin. semduramycin) as adverse reactions (a) Specifications. Type A article con- may occur. If signs of toxicity occur, taining 363.2 grams of tiamulin hydro- discontinue use. gen fumarate per pound. (2) The effects of tiamulin on swine (b) Approvals. See No. 058198 in reproductive performance, pregnancy, § 510.600(c) of this chapter. and lactation have not been deter- (c) Related tolerances. See § 556.732 of mined. this chapter. (d) Special considerations. (1) Swine (3) Use as sole source of tiamulin. being treated with tiamulin should not (e) Conditions of use—(1) Swine. It is have access to feeds containing used as follows:

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

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

(2) Tiamulin may also be used in (3) Labeling of tilmicosin Type B or combination with chlortetracycline as Type C medicated feeds must bear the in § 558.128. following warnings: (i) Do not allow horses or other [67 FR 7268, Feb. 19, 2002, as amended at 69 FR 62407, Oct. 26, 2004; 70 FR 75018, Dec. 19, equines access to feeds containing 2005; 74 FR 6, Jan. 2, 2009; 77 FR 24139, Apr. 23, tilmicosin. 2012; 79 FR 13546, Mar. 11, 2014. Redesignated (ii) [Reserved] and amended at 80 FR 13232, Mar. 13, 2015; 81 (4) Special considerations for use of FR 95015, Dec. 27, 2016] tilmicosin medicated swine feeds include the following: § 558.618 Tilmicosin. (i) The expiration date of VFDs for (a) Specifications. Type A medicated tilmicosin must not exceed 90 days article containing 90.7 grams (g) per from 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 swine must (b) Approvals. See Nos. 016592 and bear the following warning: ‘‘Do not 058198 in § 510.600(c) of this chapter. use in any feeds containing bentonite. (c) Related tolerances. See § 556.735 of Bentonite in feeds may affect the effi- this chapter. cacy of tilmicosin.’’ (d) Special considerations—(1) Federal (iii) Feed containing tilmicosin shall law restricts medicated feed containing not be fed to pigs for more than 21 days this veterinary feed directive (VFD) during each phase of production with- drug to use by or on the order of a li- out ceasing administration for reevalu- censed veterinarian. See § 558.6 for addi- ation of antimicrobial use by a licensed tional requirements. veterinarian before reinitiating a fur- (2) VFDs for tilmicosin phosphate ther course of therapy with an appro- shall not be refilled. priate antimicrobial.

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(5) Special consideration for use of BRD must be initiated during the first tilmicosin medicated cattle feeds in- 45 days of the production period, shall clude the following: not exceed a single 14-consecutive-day (i) The expiration date of VFDs for treatment, should not occur concur- cattle must not exceed 45 days from rent with or following administration the time of issuance. of an injectable macrolide, and should (ii) Labeling of tilmicosin Type B or not occur within 3 days following ad- Type C medicated feeds for cattle must ministration of a nonmacrolide bear the following warning: ‘‘Do not injectable BRD therapy. Tilmicosin use in any feeds containing bentonite, medicated feed treatment has not been cottonseed meal, or cottonseed hulls. evaluated in cattle with severe clinical Bentonite, cottonseed meal, or cotton- disease. Cattle with severe clinical ill- seed hulls in feeds may affect the effi- ness should be evaluated for individual cacy of tilmicosin.’’ treatment with an alternative non- (iii) To assure both food safety and macrolide therapy. responsible use in cattle, administra- (e) Conditions of use. It is used in feed tion of feed containing tilmicosin to as follows: cattle experiencing an outbreak of (1) Swine—

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

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

(2) Cattle—

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

(i) 568 to 757 ...... Beef and nonlactating Feed continuously for 14 days to pro- 058198, dairy cattle: For the vide 12.5 mg tilmicosin/kg of body- 016592 control of bovine res- weight/day. The safety of tilmicosin piratory disease has not been established in cattle in- (BRD) associated with tended for breeding purposes. This Mannheimia drug product is not approved for use haemolytica, in female dairy cattle 20 months of Pasteurella multocida, age or older. Use in these cattle may and Histophilus somni cause drug residues in milk. This in groups of beef and drug product is not approved for use nonlactating dairy cat- in calves intended to be processed tle, where active BRD for veal. A withdrawal period has not has been diagnosed been established in preruminating in at least 10 percent calves. Cattle intended for human of the animals in the consumption must not be slaugh- group. tered within 28 days of the last treatment with this drug product.

513

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

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

[61 FR 68148, Dec. 27, 1996; 62 FR 15391, Apr. 1, (3) No. 058198: Type A medicated arti- 1997, as amended at 64 FR 13679, Mar. 22, 1999; cles containing 10, 40, or 100 g/lb. 65 FR 76930, Dec. 8, 2000; 67 FR 21997, May 2, (4) No. 066104: Type A medicated arti- 2002; 69 FR 78306, Dec. 30, 2004; 76 FR 76894, Dec. 9, 2011; 77 FR 60623, Oct. 4, 2012; 78 FR cles containing 20 or 40 g/lb. 19987, Apr. 3, 2013; 80 FR 61298, Oct. 13, 2015; (c) Related tolerances. See § 556.746 of 80 FR 76387, Dec. 9, 2015; 81 FR 48703, July 26, this chapter. 2016; 81 FR 59135, Aug. 29, 2016; 81 FR 67153, (d) Special considerations. (1) Federal Sept. 30, 2016; 85 FR 18123, Apr. 1, 2020] law restricts medicated feed containing § 558.625 Tylosin. this veterinary feed directive (VFD) drug to use by or on the order of a li- (a) Specifications. Type A medicated censed veterinarian. See § 558.6 for addi- articles containing tylosin phosphate. tional requirements. (b) Sponsors. See sponsor numbers in (2) The expiration date of VFDs for § 510.600(c) of this chapter. tylosin medicated feeds must not ex- (1) No. 016592: Type A medicated arti- ceed 6 months from the date of cles containing 40 or 100 grams per issuance. VFDs for tylosin shall not be pound (g/lb). refilled. (2) No. 054771: Type A medicated article containing 40 g/lb.

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(3) Type C medicated feeds for cattle tank systems: Agitate immediately may be manufactured from tylosin liq- prior to use for not less than 10 min- uid Type B medicated feeds which have utes, creating a turbulence at the bot- a pH between 4.5 and 6.0 and which bear tom of the tank that is visible at the appropriate mixing directions as fol- top. Agitate daily as described even lows: when not used. (i) For liquid feeds stored in recircu- (4) Tylosin liquid Type B medicated lating tank systems: Recirculate im- feeds must bear an expiration date of 31 mediately prior to use for not less than days after the date of manufacture. 10 minutes, moving not less than 1 per- (5) Do not use tylosin liquid Type B cent of the tank contents per minute medicated feeds in any liquid feed con- from the bottom of the tank to the top. taining sodium metabisulfite or in any Recirculate daily as described even finished feed (supplement, concentrate, when not used. or complete feed) containing in excess (ii) For liquid feeds stored in me- of 2 percent bentonite. chanical, air, or other agitation-type (e) Conditions of use—(1) Swine—

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

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

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

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

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

(xii) 100 ...... Pyrantel, 96 ...... For reduction in severity of ef- Feed continuously as the sole 066104 fects of atrophic rhinitis; aid as ration. Tylosin phosphate and an aid in the prevention of mi- pyrantel as provided by No. gration and establishment of 066104 in § 510.600(c) of this large roundworm (Ascaris chapter. Tylosin phosphate suum) infections; aid in the and pyrantel as provided by prevention of establishment of No. 066104 in § 510.600(c) of nodular worm this chapter. (Oesophagostomum spp.) infections. (xiii) 100 ...... Ractopamine, 4.5 to For the control of porcine prolif- Feed continuously as the sole 016592 9.0. erative enteropathies (PPE, il- ration to finishing swine 054771 eitis) associated with weighing not less than 150 lbs 058198 Lawsonia intracellularis; and for the last 45 to 90 lbs (group for increased rate of weight average) of weight gain prior gain, improved feed efficiency, to slaughter. Include 100 g/ton and increased carcass lean- of tylosin for 3 weeks. Tylosin ness in finishing swine weigh- phosphate as provided by ing not less than 150 lbs, fed Nos. 058198 and 016592; a complete ration containing ractopamine as provided by at least 16% crude protein for Nos. 058198 and 054771 in the last 45 to 90 lbs of gain § 510.600(c) of this chapter. prior to slaughter.

(2) Cattle—

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

(i) 8 to 10 ...... Beef cattle: For reduction of inci- Feed continuously as the sole 016592 dence of liver abscesses ration to provide 60 to 90 mg/ 054771 caused by Fusobacterium head/day tylosin. 058198 necrophorum and 066104 Arcanobacterium (Actinomyces) pyogenes. (ii) 8 to 10 ...... Lasalocid, 100 to Heifers fed in confinement for Feed continuously as sole ra- 016592 1440; plus slaughter: For reduction of in- tion. Feed to heifers at the 054771 melengestrol, cidence of liver abscesses rate of 0.5 to 2.0 pound(s) per 058198 0.25 to 2.0. caused by Fusobacterium head per day (specify one necrophorum and level) to provide 0.25 to 0.5 Arcanobacterium pyogenes; mg melengestrol acetate per and for increased rate of head per day (specify one weight gain, improved feed ef- level), 100 to 360 mg ficiency, and suppression of lasalocid per head per day estrus (heat). (specify one level), and 90 mg tylosin per head per day. This Type C product may be top dressed onto or mixed into a complete feed prior to feeding. Tylosin as provided by Nos. 016592 and 058198; lasalocid as provided by No. 054771; melengestrol as provided by Nos. 054771 and 058198 in § 510.600(c) of this chapter. See §§ 558.311(d) and 558.342(d) in this chapter.

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

(iii) 8 to 10 ...... Melengestrol, 0.25 Heifers fed in confinement for Feed continuously as sole ra- 016592 to 2.0. slaughter: For reduction of in- tion. Each pound contains 054771 cidence of liver abscesses 0.125 to 1.0 mg melengestrol 058198 caused by Fusobacterium acetate and 45 to 180 mg of necrophorum and tylosin. Feed to heifers at a Arcanobacterium pyogenes; rate of 0.5 to 2.0 pounds per and for increased rate of head per day to provide 0.25 weight gain, improved feed ef- to 0.5 mg melengestrol ace- ficiency, and suppression of tate and 60 to 90 mg tylosin estrus (heat). per head per day. Prior to feeding, this Type C product must be top-dressed onto a complete feed or mixed into the amount of complete feed consumed by an animal per day. Tylosin provided by Nos. 016592 and 058198; melengestrol provided by Nos. 054771 and 058198 in § 510.600(c) of this chapter. See § 558.342(d) in this chapter. (iv) 8 to 10 ...... Monensin, 5 to 40 .. Cattle fed in confinement for Feed continuously as sole ration 016592 slaughter: For reduction of in- to provide 50 to 480 monensin 058198 cidence of liver abscesses mg/head/day and 60 to 90 caused by Fusobacterium mg/head/day tylosin. A with- necrophorum and drawal time has not been es- Arcanobacterium tablished for pre-ruminating (Actinomyces) pyogenes; and calves. Do not use in calves for improved feed efficiency. to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by Nos. 016592 or 058198 in § 510.600(c) of this chapter. See § 558.355(d) in this chapter. (v) 8 to 10 ...... Monensin, 10 to 40 Cattle fed in confinement for Feed continuously as sole ration 016592 slaughter: For reduction of in- to provide 0.14 to 0.42 mg 058198 cidence of liver abscesses monensin/lb body weight per caused by Fusobacterium day, depending on the sever- necrophorum and ity of the coccidiosis chal- Arcanobacterium lenge, up to 480 mg/head/day (Actinomyces) pyogenes; and and 60 to 90 mg/head/day for prevention of coccidiosis tylosin. A withdrawal time has caused by Eimeria bovis and not been established for pre- E zuernii. ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by Nos. 016592 or 058198 in § 510.600(c) of this chapter. See § 558.355(d) in this chapter.

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

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

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

(vii) 8 to 10 ...... Monensin, 5 to 40 Beef steers and heifers fed in Feed continuously as sole ration 058198 plus lubabegron confinement for slaughter: For to provide 13 to 90 mg fumarate, 1.25 to reduction of ammonia gas lubabegron/head/day, 50 to 4.54. emissions per pound of live 480 mg monensin/head/day, weight and hot carcass and 60 to 90 mg tylosin/head/ weight; for reduction of inci- day during the last 14 to 91 dence of liver abscesses as- days on feed. No additional sociated with Fusobacterium improvement in feed efficiency necrophorum and has been shown from feeding Arcanobacterium pyogenes, monensin at levels greater and for improved feed effi- than 30 g/ton (360 mg ciency during the last 14 to 91 monensin/head/day. A de- days on feed. crease in dry matter intake may be noticed in some animals receiving lubabegron. Lubabegron has not been approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal.

520

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

(viii) 8 to 10 ...... Monensin, 10 to 40 Beef steers and heifers fed in Feed continuously as sole ration 058198 plus lubabegron confinement for slaughter: For to provide 13 to 90 mg fumarate, 1.25 to reduction of ammonia gas lubabegron/head/day, 0.14 to 4.54. emissions per pound of live 0.42 mg monensin/lb body weight and hot carcass weight per day, depending weight, for reduction of inci- upon severity of coccidiosis dence of liver abscesses as- challenge, up to 480 mg/head/ sociated with Fusobacterium day, and 60 to 90 mg tylosin/ necrophorum and head/day during the last 14 to Arcanobacterium pyogenes, 91 days on feed. A decrease and for prevention and control in dry matter intake may be of coccidiosis due to Eimeria noticed in some animals re- bovis and E. zuernii during the ceiving lubabegron. last 14 to 91 days on feed. Lubabegron has not been approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal.

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

(ix) 8 to 10 ...... Monensin, 10 to 40 Heifers fed in confinement for Feed continuously as sole ration 016592 plus melengestrol, slaughter: For reduction of in- to heifers at a rate of 0.5 to 2 054771 0.25 to 2.0. cidence of liver abscesses pounds per head per day to 058198 caused by Fusobacterium provide 0.25 to 0.5 mg/head/ necrophorum and day melengestrol acetate and Arcanobacterium 0.14 to 0.42 mg monensin/lb (Actinomyces) pyogenes; for body weight per day, depend- prevention and control of coc- ing on the severity of the coccidiosis caused by Eimeria cidiosis challenge, up to 480 bovis and E. zuernii; and for mg/head/day and 60 to 90 increased rate of weight gain, mg/head/day tylosin. The improved feed efficiency, and melengestrol acetate portion suppression of estrus (heat). of this Type C medicated feed must be mixed into the complete feed containing 10 to 40 g/ton monensin and 8 to 10 g/ ton tylosin at feeding into the amount of complete feed consumed by an animal per day. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; melengestrol provided by No. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.342(d) and 558.355(d). (x) 8 to 10 ...... Monensin, 10 to 40 Cattle fed in confinement for Feed continuously as sole ration 016592 plus ractopamine, slaughter: For reduction of in- to provide 70 to 430 mg/head/ 054771 8.2 to 24.6. cidence of liver abscesses day ractopamine and 0.14 to 058198 caused by Fusobacterium 0.42 mg monensin/lb body necrophorum and weight per day, depending on Arcanobacterium pyogenes; the severity of the coccidiosis for prevention and control of challenge, up to 480 mg/head/ coccidiosis caused by Eimeria day and 60 to 90 mg/head/ bovis and E zuernii; and for day tylosin for the last 28 to increased rate of weight gain 42 days on feed. A withdrawal and improved feed efficiency time has not been established in cattle fed in confinement for for pre-ruminating calves. Do slaughter for the last 28 to 42 not use in calves to be proc- days on feed. essed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by Nos. 016592 or 058198; ractopamine provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.355(d) and 558.500(d) in this chapter.

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

(xi) 8 to 10 ...... Monensin, 10 to 40 Cattle fed in confinement for Feed a minimum of 1.0 lb/head/ 016592 plus ractopamine, slaughter: For reduction of in- day ractopamine Type C top 054771 not to exceed 800. cidence of liver abscesses dress feed continuously to 058198 caused by Fusobacterium cattle fed in confinement for necrophorum and slaughter, to provide 70 to Arcanobacterium pyogenes; 400 mg/head/day ractopamine for prevention and control of for the last 28 to 42 days on coccidiosis caused by Eimeria feed. Feed on top of a ration bovis and E zuernii; and for containing 10 to 40 g/ton increased rate of weight gain monensin and 8 to 10 g/ton and improved feed efficiency tylosin phosphate, to provide in cattle fed in confinement for 0.14 to 0.42 mg monensin/lb slaughter for the last 28 to 42 body weight/day, depending days on feed. on the severity of the coccidiosis challenge, up to 480 mg/ head/day and 60 to 90 mg/ head/day tylosin. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by Nos. 016592 or 058198; ractopamine provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.355(d) and 558.500(d) in this chapter. (xii) 8 to 10 ...... Monensin 10 to 40 Cattle fed in confinement for Feed continuously as sole ration 016592 plus ractopamine slaughter: For reduction of in- to provide 90 to 430 mg/head/ 054771 9.8 to 24.6. cidence of liver abscesses day ractopamine and 0.14 to 058198 caused by Fusobacterium 0.42 mg monensin/lb body necrophorum and weight per day, depending on Arcanobacterium pyogenes; the severity of the coccidiosis for prevention and control of challenge, up to 480 mg/head/ coccidiosis caused by Eimeria day and 60 to 90 mg/head/ bovis and E zuernii; and for day tylosin for the last 28 to increased rate of weight gain, 42 days on feed. A withdrawal improved feed efficiency, and time has not been established increased carcass leanness in for pre-ruminating calves. Do cattle fed in confinement for not use in calves to be proc- slaughter for the last 28 to 42 essed for veal. Tylosin pro- days on feed. vided by Nos. 016592 or 058198; monensin as provided by Nos. 016592 or 058198; ractopamine as provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.355(d) and 558.500(d) in this chapter.

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

(xiii) 8 to 10 ...... Monensin, 10 to 40 Heifers fed in confinement for Feed continuously as sole ration 016592 plus ractopamine, slaughter: For reduction of in- to provide 90 to 430 mg/head/ 054771 9.8 to 24.6 plus cidence of liver abscesses day ractopamine and 0.14 to 058198 melengestrol, caused by Fusobacterium 0.42 mg monensin/lb body 0.125 to 1 mg/lb. necrophorum and weight per day, depending on Arcanobacterium the severity of the coccidiosis (Actinomyces) pyogenes; for challenge, up to 480 mg/head/ prevention and control of coc- day and 60 to 90 mg/head/ cidiosis caused by Eimeria day tylosin for the last 28 to bovis and E zuernii; for in- 42 days on feed. Feed creased rate of weight gain, melengestrol as a top dress or improved feed efficiency, and mixed with a complete ration increased carcass leanness; at the rate of 0.5 to 2.0 and suppression of estrus pound/head/day (specify one (heat). level) to provide 0.25 to 0.5 mg melengestrol acetate/ head/day (specify one level). A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by Nos. 016592 or 058198; ractopamine as provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.342(d), 558.355(d), and 558.500(d) in this chapter. (xiv) 8 to 10 ...... Monensin, 10 to 40 Cattle fed in confinement for Feed continuously as the sole 000061 plus zilpaterol, 6.8. slaughter: For reduction of in- ration to cattle during the last 016592 cidence of liver abscesses 20 to 40 days on feed to pro- caused by Fusobacterium vide 60 to 90 mg/head/day necrophorum and zilpaterol, 0.14 to 0.42 mg/lb Arcanobacterium pyogenes; body weight/day monensin, for prevention and control of depending on the severity of coccidiosis caused by Eimeria the coccidiosis challenge, up bovis and E zuernii; and for to 480 mg/head/day increased rate of weight gain, monensin, and 60 to 90 mg/ improved feed efficiency, and head/day tylosin. Do not use increased carcass leanness in in veal calves. Withdrawal pe- cattle fed in confinement for riod 3 days. Tylosin provided slaughter for the last 20 to 40 by Nos. 016592 or 058198; days on feed. monensin as provided by No. 058198; zilpaterol as provided by No. 000061 in § 510.600(c) of this chapter. See §§ 558.355(d) and 558.665(d) in this chapter. (xv) 8 to 10 ...... Monensin, 10 to 40 Cattle fed in confinement for Feed this component feed con- 000061 plus zilpaterol, 6.8 slaughter: For reduction of in- tinuously to cattle during the 016592 to 24. cidence of liver abscesses last 20 to 40 days on feed to caused by Fusobacterium provide 60 mg/head/day necrophorum and zilpaterol, 0.14 to 0.42 mg/lb Arcanobacterium pyogenes; body weight/day monensin, for prevention and control of depending on the severity of coccidiosis caused by Eimeria the coccidiosis challenge, up bovis and E zuernii; and for to 480 mg/head/day increased rate of weight gain, monensin, and 60 to 90 mg/ improved feed efficiency, and head/day tylosin. Do not use increased carcass leanness in in veal calves. Withdrawal pe- cattle fed in confinement for riod 3 days. Tylosin provided slaughter for the last 20 to 40 by Nos. 016592 or 058198; days on feed. monensin as provided by No. 058198; zilpaterol as provided by No. 000061 in § 510.600(c) of this chapter. See §§ 558.355(d) and 558.665(d) in this chapter.

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

(xvi) 8 to 10 ...... Monensin, 10 to 40 Heifers fed in confinement for Feed continuously as the sole 000061 plus zilpaterol, 6.8 slaughter: For reduction of in- ration to cattle during the last 016592 plus melengestrol, cidence of liver abscesses 20 to 40 days on feed to pro- 058198 0.125 to 1 mg/lb. caused by Fusobacterium vide 60 to 90 mg/head/day necrophorum and zilpaterol, 0.14 to 0.42 mg/lb Arcanobacterium body weight/day monensin, (Actinomyces) pyogenes; for depending on the severity of prevention and control of coc- the coccidiosis challenge, up cidiosis caused by Eimeria to 480 mg/head/day bovis and E zuernii; and for monensin, and 60 to 90 mg/ increased rate of weight gain, head/day tylosin. Feed improved feed efficiency, and melengestrol as a top dress or increased carcass leanness in mixed with a complete ration cattle fed in confinement for at the rate of 0.5 to 2.0 slaughter for the last 20 to 40 pound/head/day (specify one days on feed; and for sup- level) to provide 0.25 to 0.5 pression of estrus (heat). mg melengestrol acetate/ head/day (specify one level). Do not use in veal calves. Withdrawal period 3 days. Tylosin as provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061; melengestrol provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.342(d), 558.355(d) and 558.665(d) in this chapter. (xvii) 8 to 10 ...... Monensin, 10 to 40 Heifers fed in confinement for Feed this component feed con- 000061 plus zilpaterol, 6.8 slaughter: For reduction of in- tinuously to cattle during the 016592 to 24 plus cidence of liver abscesses last 20 to 40 days on feed to 058198 melengestrol, caused by Fusobacterium provide 60 mg/head/day 0.125 to 1 mg/lb. necrophorum and zilpaterol, 0.14 to 0.42 mg/lb Arcanobacterium body weight/day monensin, (Actinomyces) pyogenes; for depending on the severity of prevention and control of coc- the coccidiosis challenge, up cidiosis caused by Eimeria to 480 mg/head/day bovis and E zuernii; and for monensin, and 60 to 90 mg/ increased rate of weight gain, head/day tylosin. Feed improved feed efficiency, and melengestrol as a top dress or increased carcass leanness in mixed with a complete ration cattle fed in confinement for at the rate of 0.5 to 2.0 slaughter for the last 20 to 40 pound/head/day (specify one days on feed; and for sup- level) to provide 0.25 to 0.5 pression of estrus (heat). mg melengestrol acetate/ head/day (specify one level). Do not use in veal calves. Withdrawal period 3 days. Tylosin as provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061; melengestrol provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.342(d), 558.355(d) and 558.665(d) in this chapter.

[40 FR 13959, Mar. 27, 1975] § 558.630 Tylosin and sulfamethazine. EDITORIAL NOTE: For FEDERAL REGISTER ci- (a) Specifications. Type A medicated tations affecting § 558.625, see the List of CFR articles containing equal amounts of Sections Affected, which appears in the tylosin phosphate and sulfamethazine, Finding Aids section of the printed volume and at www.govinfo.gov. available in concentrations of 5, 10, 20, or 40 grams each, per pound.

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(b) Sponsors. See sponsor numbers in censed veterinarian. See § 558.6 for addi- § 510.600(c) of this chapter. tional requirements. (1) No. 058198 for use as in paragraph (2) The expiration date of VFDs for (e)(1) of this section. tylosin and sulfamethazine medicated (2) No. 054771: 10 or 40 grams per feeds must not exceed 6 months from pound each for use as in paragraph the date of issuance. VFDs for tylosin (e)(2) of this section. and sulfamethazine shall not be re- (c) Related tolerances. See §§ 556.670 filled. and 556.746 of this chapter. (3) Labeling shall bear the statement: (d) Special considerations. (1) Federal ‘‘Do not use in medicated feeds con- law restricts medicated feed containing taining in excess of 2% bentonite.’’ this veterinary feed directive (VFD) (e) Conditions of use. It is used in feed drug to use by or on the order of a li- for swine as follows:

Tylosin phosphate and Combination in sulfamethazine grams/ton Indications for use Limitations Sponsors in grams/ton

(1) 100 each ...... For reduction in the severity of Withdraw 15 days before swine 058198 effects of atrophic rhinitis; low- are slaughtered. ering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery associated with Brachyspira hyodysenteriae; control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Arcanobacterium pyogenes); reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci. Only the sulfamethazine portion of this combination is active in controlling jowl abscesses. (2) 100 each ...... For reduction in the severity of Withdraw 15 days before swine 054771 effects of atrophic rhinitis; low- are slaughtered. ering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery associated with Brachyspira hyodysenteriae; and control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Arcanobacterium pyogenes).

[81 FR 95021, Dec. 27, 2016, as amended at 84 FR 33002, July 11, 2019]

§ 558.633 Tylvalosin. censed veterinarian. See § 558.6 for addi- (a) Specifications. Type A medicated tional requirements. articles containing 77.12 grams (2) VFDs for tylvalosin shall not be tylvalosin per pound as tylvalosin tar- refilled. trate. (3) An expiration date of 1 week is re- (b) Sponsor. See No. 066916 in quired for tylvalosin Type C medicated § 510.600(c) of this chapter. swine feeds in pelleted or crumbled (c) Related tolerances. See § 556.748 of form. this chapter. (e) Conditions of use. (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a li-

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Tylvalosin in grams/ton Indications for use Limitations Sponsor

(i) 38.6 Swine: For the control of porcine prolif- Feed continuously as the sole ration for 066916 erative enteropathy (PPE) associated 14 consecutive days. with Lawsonia intracellularis infection in groups of swine in buildings experiencing an outbreak of PPE. (ii) [Reserved]

[81 FR 36790, June 8, 2016, as amended at 81 drug to use by or on the order of a li- FR 67153, Sept. 30, 2016; 84 FR 12504, Apr. 2, censed veterinarian. See § 558.6 for addi- 2019] tional requirements. (2) The expiration date of VFDs for § 558.635 Virginiamycin. virginiamycin medicated feeds must (a) Specifications. Type A medicated not exceed 6 months from the date of articles containing 10, 20, 50, or 227 issuance. VFDs for virginiamycin shall grams virginiamycin per pound. not be refilled. (b) Sponsors. See No. 066104 in (3) Not for use in breeding swine over § 510.600(c) of this chapter. 120 pounds. (c) Related tolerances. See § 556.750 of (4) Dilute Type A article with at this chapter. least 10 pounds of a feed ingredient (d) Special considerations. (1) Federal prior to final mixing in 1 ton of Type C law restricts medicated feed containing feed. this veterinary feed directive (VFD) (e) Conditions of use—(1) Chickens—

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

(i) 20 ...... Broiler chickens: For prevention Not for use in layers ...... 066104 of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin. (ii) 20 ...... Amprolium 72.6 to Broiler chickens: For prevention For field conditions where only 066104 113.5. of necrotic enteritis caused by E. tenella is the major prob- Clostridium perfringens sus- lem, feed continuously as the ceptible to virginiamycin; and sole ration. Use as the sole for the prevention of coccidi- source of amprolium. Do not osis caused by Eimeria tenella. use in feeds containing bentonite. Not for use in laying chickens. Amprolium as provided by No. 016592 in § 510.600(c) of this chapter. (iii) 20 ...... Amprolium 113.5 to Broiler chickens: For prevention For most field conditions as they 066104 227. of necrotic enteritis caused by exist under modern manage- Clostridium perfringens sus- ment practices, feed 113.5 g/ ceptible to virginiamycin; and ton amprolium continuously. for the prevention of coccidi- Where severe coccidiosis con- osis where immunity to coc- ditions exist, feed 227 g/ton. cidiosis is not desired. Use as the sole source of amprolium. Do not use in feeds containing bentonite. Not for use in laying chickens. Amprolium as provided by No. 016592 in § 510.600(c) of this chapter.

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

(iv) 20 ...... Diclazuril 0.91 ...... Broiler chickens: For prevention Feed continuously as the sole 058198 of necrotic enteritis caused by ration. Do not use in hens Clostridium perfringens sus- producing eggs for human ceptible to virginiamycin; and food. Diclazuril as provided by for the prevention of coccidi- No. 058198 in § 510.600(c) of osis caused by Eimeria this chapter. tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Be- cause diclazuril is effective against E. maxima late in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesions scores and improve performance and health of birds challenged with E. maxima. (v) 20 ...... Lasalocid 68 to 113 Broiler chickens: For prevention Feed continuously as the sole 066104 of necrotic enteritis caused by ration. Do not feed to laying Clostridium perfringens sus- chickens. For broiler or fryer ceptible to virginiamycin; and chickens only. Lasalocid as for the prevention of coccidi- provided by No. 054771 in osis caused by Eimeria § 510.600(c) of this chapter. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima. (vi) 20 ...... Monensin 90 to 110 Broiler chickens: For prevention Feed continuously as the sole 066104 of necrotic enteritis caused by ration. Do not feed to laying Clostridium perfringens sus- chickens. See § 558.355(d) in ceptible to virginiamycin; and this chapter. Monensin as pro- as an aid in the prevention of vided by No. 058198 in coccidiosis caused by Eimeria § 510.600(c) of this chapter. necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati. (vii) 20 ...... Salinomycin 40 to Broiler chickens: For prevention Feed continuously as the sole 60. of necrotic enteritis caused by ration. Do not feed to chick- Clostridium perfringens sus- ens over 16 weeks of age. Do ceptible to virginiamycin; and not feed to laying chickens. for the prevention of coccidi- Not approved for use with pel- osis caused by Eimeria let binders. May be fatal if ac- tenella, E. necatrix, E. cidentally fed to adult turkeys acervulina, E. maxima, E. or horses. Salinomycin as pro- brunetti, and E. mivati. vided by No. 016592 in § 510.600(c) of this chapter. (viii) 20 ...... Semduramicin 22.7 Broiler chickens: For prevention Feed continuously as the sole 066104 of necrotic enteritis caused by ration. Do not feed to laying Clostridium perfringens sus- hens. Semduramicin as pro- ceptible to virginiamycin; and vided by No. 066104 in for the prevention of coccidi- § 510.600(c) of this chapter. osis caused by Eimeria acervulina, E. brunetti, E. maxima, E mivati/mitis, E. necatrix, and E. tenella. (ix) 20 ...... Semduramicin (bio- Broiler chickens: For prevention Feed continuously as the sole 066104 mass) 22.7. of necrotic enteritis caused by ration. Withdraw 1 day before Clostridium perfringens sus- slaughter. Do not feed to lay- ceptible to virginiamycin; and ing hens. Semduramicin as for the prevention of coccidi- provided by No. 066104 in osis caused by Eimeria § 510.600(c) of this chapter. acervulina, E. brunetti, E. maxima, E mivati/mitis, E. necatrix, and E. tenella.

(2) Swine—

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

(i) 25...... Growing-finishing swine: As an ...... 066104 aid in control of dysentery in swine up to 120 pounds in animals or on premises with a history of swine dysentery but where symptoms have not yet occurred. (ii) 50 or 100 ...... Growing-finishing swine: For Feed 100 grams per ton for 2 066104 treatment and control of swine weeks, 50 grams per ton dysentery in swine up to 120 thereafter. pounds. (iii) 100...... Growing-finishing swine: For Feed for 2 weeks ...... 066104 treatment of swine dysentery in nonbreeding swine over 120 pounds.

(3) Cattle—

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

(i) 13.5 to 16.0...... Cattle fed in confinement for Feed continuously as the sole 066104 slaughter: For reduction of in- ration to provide 85 to 240 cidence of liver abscesses. milligrams per head per day. Not for use in animals intended for breeding. (ii) [Reserved]

[81 FR 95022, Dec. 27, 2016, as amended at 82 FR 11512, Feb. 24, 2017; 82 FR 21692, May 10, 2017; 85 FR 18125, Apr. 1, 2020]

§ 558.665 Zilpaterol. matter basis), zilpaterol should not be (a) Specifications. Type A medicated fed in complete feed.’’ articles containing 21.77 grams (g) (4) Type B Liquid Feeds can be manu- zilpaterol hydrochloride per pound. factured containing 68 to 680 g (b) Approvals. See No. 000061 in zilpaterol hydrochloride/ton. The liquid § 510.600(c) of this chapter. Type B feeds must be maintained at a (c) Tolerances. See § 556.765 of this pH of 3.8 to 7.5. For liquid feeds stored chapter. in recirculating tank systems: Recircu- (d) Special considerations. (1) Labeling late immediately prior to use for not shall bear the following caution state- less than 10 minutes, moving not less ments: ‘‘Zilpaterol hydrochloride is not than 1 percent of the tank contents per for use in animals intended for breed- minute from the bottom of the tank to ing. Do not allow horses or other the top. Recirculate daily as described equines access to feed containing even when not used. For liquid feeds zilpaterol. Do not use in veal calves.’’ stored in mechanical, air or other agi- (2) Labeling of Type A medicated ar- tation-type tank systems: Agitate im- ticles and Type B medicated feeds used mediately prior to use for not less than to manufacture complete Type C medi- 10 minutes, creating a turbulence at cated feeds shall bear the caution the bottom of the tank that is visible statement in paragraph (d)(3) of this at the top. Agitate daily as described section. even when not used. (3) Labeling of complete Type C medicated feeds shall bear the fol- (e) Conditions of use in cattle. It is ad- lowing caution statements: ‘‘Not to be ministered in feed as follows: fed to cattle in excess of 90 mg zilpaterol/head/day in complete feed. If pen consumption of complete feed exceeds 26.5 lb/head/day (90 percent dry

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

(1) 6.8...... Cattle fed in confinement for Feed continuously as the sole ra- 000061 slaughter: For increased rate of tion during the last 20 to 40 weight gain, improved feed effi- days on feed to provide 60 to ciency, and increased carcass 90 mg zilpaterol hydrochloride leanness in cattle fed in con- per head per day. Withdrawal finement for slaughter during period: 3 days. See paragraph the last 20 to 40 days on feed. (d) of this section. (2) 6.8 ...... Monensin 10 to 40 Cattle fed in confinement for Feed continuously as the sole ra- 000061 slaughter: For increased rate of tion during the last 20 to 40 058198 weight gain, improved feed effi- days on feed to provide 60 to ciency, and increased carcass 90 mg zilpaterol hydrochloride leanness in cattle fed in con- per head per day and 0.14 to finement for slaughter during 0.42 mg monensin per pound the last 20 to 40 days on feed; of body weight per day depend- for prevention and control of ing on the severity of the coc- coccidiosis due to Eimeria cidiosis challenge, up to 480 bovis and E. zuernii. mg/head/day monensin. With- drawal period: 3 days. See paragraph (d) of this section. See paragraph § 558.355(d) of this chapter Monensin as provided by No. 058198 in § 510.600(c) of this chapter. (3) 6.8 ...... Melengestrol ace- Heifers fed in confinement for Feed continuously as the sole ra- 000061 tate to provide slaughter: For increased rate of tion during the last 20 to 40 058198 0.25 to 0.5 mg/ weight gain, improved feed effi- days on feed to provide 60 to head/day. ciency, and increased carcass 90 mg zilpaterol hydrochloride leanness in cattle fed in con- per head per day. Withdrawal finement for slaughter during period: 3 days. See paragraph the last 20 to 40 days on feed; (d) of this section. and for suppression of estrus Melengestrol acetate as provided (heat). by Nos. 058198 or 054771 in § 510.600(c) of this chapter. (4) 6.8 ...... Monensin 10 to 40 Heifers fed in confinement for Feed continuously as the sole ra- 000061 plus melengestrol slaughter: For increased rate of tion during the last 20 to 40 058198 acetate to provide weight gain, improved feed effi- days on feed to provide 60 to 0.25 to 0.5 mg/ ciency, and increased carcass 90 mg zilpaterol hydrochloride head/day. leanness in cattle fed in con- per head per day and 0.14 to finement for slaughter during 0.42 mg monensin per pound the last 20 to 40 days on feed; of body weight per day depend- for prevention and control of ing on the severity of the coc- coccidiosis due to Eimeria cidiosis challenge, up to 480 bovis and E. zuernii; and for mg/head/day monensin. With- suppression of estrus (heat). drawal period: 3 days. See paragraph (d) of this section. See paragraphs §§ 558.342(d) and 558.355(d) of this chapter. Monensin as provided by No. 058198; melengestrol acetate as provided by Nos. 058198 or 054771 in § 510.600(c) of this chapter. (5)–(6) [Reserved]. (7) 6.8 to 24...... Cattle fed in confinement for Feed continuously during the last 000061 slaughter: For increased rate of 20 to 40 days on feed to pro- weight gain, improved feed effi- vide 60 mg zilpaterol hydro- ciency, and increased carcass chloride per head per day. leanness in cattle fed in con- Withdrawal period: 3 days. See finement for slaughter during paragraph (d) of this section. the last 20 to 40 days on feed.

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

(8) 6.8 to 24 ...... Monensin 10 to 40 Cattle fed in confinement for Feed continuously during the last 000061 slaughter: For increased rate of 20 to 40 days on feed to pro- weight gain, improved feed effi- vide 60 mg zilpaterol hydro- ciency, and increased carcass chloride per head per day and leanness in cattle fed in con- 0.14 to 0.42 mg monensin per finement for slaughter during pound of body weight per day the last 20 to 40 days on feed; depending on the severity of and for prevention and control the coccidiosis challenge, up to of coccidiosis due to Eimeria 480 mg/head/day monensin. bovis and E. zuernii. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraph § 558.355(d) of this chapter. Monensin as provided by No. 058198 in § 510.600(c) of this chapter. (9) 6.8 to 24 ...... Melengestrol ace- Heifers fed in confinement for Feed continuously during the last 000061 tate to provide slaughter: For increased rate of 20 to 40 days on feed to pro- 0.25 to 0.5 mg/ weight gain, improved feed effi- vide 60 mg zilpaterol hydro- head/day. ciency, and increased carcass chloride per head per day. leanness in cattle fed in con- Withdrawal period: 3 days. See finement for slaughter during paragraph (d) of this section. the last 20 to 40 days on feed; See paragraph § 558.342(d) of and for suppression of estrus this part. (heat). Melengestrol acetate as provided by No. 054771 in § 510.600(c) of this chapter. (10) 6.8 to 24 ...... Monensin 10 to 40, Heifers fed in confinement for Feed continuously during the last 000061 plus melengestrol slaughter: For increased rate of 20 to 40 days on feed to pro- acetate to provide weight gain, improved feed effi- vide 60 mg zilpaterol hydro- 0.25 to 0.5 mg/ ciency, and increased carcass chloride per head per day and head/day. leanness in cattle fed in con- 0.14 to 0.42 mg monensin per finement for slaughter during pound of body weight per day the last 20 to 40 days on feed; depending on the severity of for prevention and control of the coccidiosis challenge, up to coccidiosis due to Eimeria 480 mg/head/day monensin. bovis and E. zuernii; and for Withdrawal period: 3 days. See suppression of estrus (heat). paragraph (d) of this section. See paragraphs §§ 558.342(d) and 558.355(d) of this chapter. Monensin as provided by No. 058198; melengestrol acetate as provided by No. 054771 in § 510.600(c) of this chapter.

(f) Zilpaterol may also be used in § 558.680 Zoalene. combination with tylosin as in § 558.625. (a) Specifications. Type A medicated [71 FR 53006, Sept. 8, 2006, as amended at 72 article containing 25 percent zoalene. FR 9245, Mar. 1, 2007; 72 FR 6019, Feb. 1, 2008; (b) Approvals. See No. 054771 in 73 FR 14385, Mar. 18, 2008; 73 FR 16755, Mar. 31, 2008; 73 FR 18959, Apr. 8, 2008; 73 FR 19432, § 510.600(c) of this chapter. Apr. 10, 2008; 74 FR 61517, Nov. 25, 2009; 75 FR (c) Related tolerances. See § 556.770 of 11451, Mar. 11, 2010; 77 FR 31724, May 30, 2012; this chapter. 78 FR 42008, July 15, 2013; 78 FR 52852, Aug. (d) Conditions of use—(1) Chickens— 27, 2013; 80 FR 13232, Mar. 13, 2015; 80 FR 53460, Sept. 4, 2015; 81 FR 48703, July 26, 2016; 81 FR 95025, Dec. 27, 2016]

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

(i) 36.3 to 113.5 ...... Replacement chickens: For devel- Grower ration not to be fed to 054771 opment of active immunity to birds over 14 weeks of age; as coccidiosis. follows:

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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 Replacement chickens: For devel- Feed continuously as sole ration 054771 methylenedisalicy- opment of active immunity to as in subtable in item (i). Grow- late 4 to 50. coccidiosis; and for increased er ration not to be fed to birds rate of weight gain and im- over 14 weeks of age. Baci- proved feed efficiency. tracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. (iii) 36.3–113.5 ...... Bacitracin Replacement chickens: For devel- Feed continuously as sole ration 054771 methylenedisalicy- opment of active immunity to as in subtable in item (i). Grow- late 50. coccidiosis; and as an aid in er ration not to be fed to birds the prevention of necrotic enter- over 14 weeks of age. Baci- itis caused or complicated by tracin methylenedisalicylate as Clostridium spp. or other orga- provided by No. 054771 in nisms susceptible to bacitracin. § 510.600(c) of this chapter. (iv) 36.3–113.5 ...... Bacitracin Replacement chickens: For devel- Feed continuously as sole ration 054771 methylenedisalicy- opment of active immunity to as in subtable in item (i). To late 100 to 200. coccidiosis; and as an aid in control necrotic enteritis, start the control of necrotic enteritis medication at first clinical signs caused or complicated by Clos- of disease; vary bacitracin dos- tridium spp. or other organisms age based on the severity of in- susceptible to bacitracin. fection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ton). Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. (v) 113.5 ...... Broiler chickens: For prevention Feed continuously as sole ration 054771 and control of coccidiosis. (vi) 113.5 ...... Bacitracin Broiler chickens: As an aid in the Feed continuously as sole ration. 054771 methylenedisalicy- prevention and control of coc- Bacitracin methylenedisalicylate late 4 to 50. cidiosis; and for increased rate as provided by No. 054771 in of weight gain and improved § 510.600(c) of this chapter. feed efficiency. (vii) 113.5 ...... Bacitracin Broiler chickens: For prevention Feed continuously as sole ration. 054771 methylenedisalicy- and control of coccidiosis; and Bacitracin methylenedisalicylate late 50. as an aid in the prevention of as provided by No. 054771 in necrotic enteritis caused or § 510.600(c) of this chapter. complicated by Clostridium spp. or other organisms susceptible to bacitracin. (viii) 113.5 ...... Bacitracin Broiler chickens: For prevention Feed continuously as sole ration. 054771 methylenedisalicy- and control of coccidiosis; and To control necrotic enteritis, late 100 to 200. as an aid in the control of ne- start medication at first clinical crotic enteritis caused or com- signs of disease; vary baci- plicated by Clostridium spp. or tracin dosage based on the se- other organisms susceptible to verity of infection; administer bacitracin. continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ton). Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. (ix) 113.5 ...... Bambermycins 1 ..... Broiler chickens: As an aid in the Feed continuously as sole ration. 016592 prevention and control of coc- Do not feed to chickens over cidiosis; and for increased rate 14 weeks of age. of weight gain and improved Bambermycins as provided by feed efficiency. No. 016592 in § 510.600(c) of this chapter.

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(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 Growing turkeys: For prevention Feed continuously as sole ration 054771 methylenedisalicy- and control of coccidiosis; and until 14 to 16 weeks of age. For late 4 to 50. for increased rate of weight turkeys grown for meat pur- gain and improved feed effi- poses only. Do not feed to lay- ciency. ing birds.

(3) Zoalene may also be used in com- 570.35 Affirmation of generally recognized bination with: as safe (GRAS) status. (i)–(ii) [Reserved] 570.38 Determination of food additive status. (iii) Lincomycin as in § 558.325. [41 FR 11005, Mar. 15, 1976, as amended at 42 Subparts C–D [Reserved] FR 18618, Apr. 8, 1977; 42 FR 20817, Apr. 22, 1977; 42 FR 36995, July 19, 1977; 51 FR 7401, Subpart E—Generally Recognized as Safe Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 55 FR (GRAS) Notice 8461, Mar. 8, 1990; 57 FR 8403, Mar. 10, 1992; 57 FR 8578, Mar. 11, 1992; 61 FR 35957, July 9, 570.203 Definitions. 1996; 63 FR 38750, July 20, 1998; 67 FR 6868, 570.205 Opportunity to submit a GRAS no- Feb. 14, 2002; 71 FR 16223, Mar. 31, 2006; 71 FR tice. 27958, May 15, 2006; 76 FR 17027, Mar. 28, 2011; 570.210 How to send your GRAS notice to 79 FR 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, FDA. 2014; 81 FR 17610, Mar. 30, 2016; 81 FR 95025, 570.215 Incorporation into a GRAS notice. Dec. 27, 2016; 82 FR 21693, May 10, 2017] 570.220 General requirements applicable to a GRAS notice. 570.225 Part 1 of a GRAS notice: Signed PART 564 [RESERVED] statements and certification. 570.230 Part 2 of a GRAS notice: Identity, PART 570—FOOD ADDITIVES method of manufacture, specifications, and physical or technical effect. Subpart A—General Provisions 570.235 Part 3 of a GRAS notice: Target animal and human exposures. Sec. 570.240 Part 4 of a GRAS notice: Self-lim- 570.3 Definitions. iting levels of use. 570.6 Opinion letters on food additive sta- 570.245 Part 5 of a GRAS notice: Experience tus. based on common use in food before 1958. 570.13 Indirect food additives resulting from 570.250 Part 6 of a GRAS notice: Narrative. packaging materials prior sanctioned for 570.255 Part 7 of a GRAS notice: List of sup- animal feed and pet food. porting data and information in your 570.14 Indirect food additives resulting from GRAS notice. packaging materials for animal feed and 570.260 Steps you may take before FDA re- pet food. sponds to your GRAS notice. 570.15 Adoption of regulation on initiative 570.265 What FDA will do with a GRAS no- of Commissioner. tice. 570.17 Exemption for investigational use 570.275 Public disclosure of a GRAS notice. and procedure for obtaining authoriza- 570.280 Submission of a supplement. tion to market edible products from ex- AUTHORITY: 21 U.S.C. 321, 341, 342, 346a, 348, perimental animals. 371. 570.18 Tolerances for related food additives. 570.19 Pesticide chemicals in processed SOURCE: 41 FR 38644, Sept. 10, 1976, unless foods. otherwise noted. Subpart B—Food Additive Safety Subpart A—General Provisions 570.20 General principles for evaluating the § 570.3 Definitions. safety of food additives. 570.30 Eligibility for classification as gen- (a) Secretary means the Secretary of erally recognized as safe (GRAS). Health and Human Services.

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(b) Department means the Department well as the application of scientific of Health and Human Services. principles, appropriate to establish the (c) Commissioner means the Commis- safety of a substance under the condi- sioner of Food and Drugs. tions of its intended use. (d) As used in this part, the term act (i) Safe or safety means that there is means the Federal Food, Drug, and a reasonable certainty in the minds of Cosmetic Act approved June 25, 1936 (52 competent scientists that the sub- Stat. 1040 et seq., as amended; 21 U.S.C. stance is not harmful under the condi- 301–392). tions of its intended use. It is impos- (e) Food additives includes all sub- sible in the present state of scientific stances not exempted by section 201(s) knowledge to establish with complete of the act, the intended use of which certainty the absolute harmlessness of results or may reasonably be expected the use of any substance. Safety may to result, directly or indirectly, either be determined by scientific procedures in their becoming a component of food or by general recognition of safety. In or otherwise affecting the characteris- determining safety, the following fac- tics of food. A material used in the pro- tors shall be considered: duction of containers and packages is (1) The probable consumption of the subject to the definition if it may rea- substance and of any substance formed sonably be expected to become a com- in or on food because of its use; ponent, or to affect the characteristics, directly or indirectly, of food packed in (2) The cumulative effect of the sub- the container. Affecting the characteris- stance in the diet, taking into account tics of food does not include such phys- any chemically or pharmacologically ical effects, as protecting contents of related substance or substances in such packages, preserving shape, and pre- diet; venting moisture loss. If there is no (3) Safety factors which, in the opin- migration of a packaging component ion of experts qualified by scientific from the package to the food, it does training and experience to evaluate the not become a component of the food safety of food and food ingredients, are and thus is not a food additive. A sub- generally recognized as appropriate. stance that does not become a compo- (j) The term nonperishable processed nent of food, but that is used, for exam- food means any processed food not sub- ple, in preparing an ingredient of the ject to rapid decay or deterioration food to give a different flavor, texture, that would render it unfit for consump- or other characteristic in the food, tion. Not included are hermetically may be a food additive. sealed foods and other processed foods (f) Common use in food means a sub- requiring refrigeration. stantial history of consumption of a (k) General recognition of safety shall substance by a significant number of be in accordance with § 570.30. animals of the species to which the (l) Prior sanction means an explicit substance is intended to be fed (and, for approval granted with respect to use of food-producing animals fed with such a substance in food prior to September substance, also means a substantial 6, 1958, by the Food Drug and Adminis- history of consumption by humans con- tration or the United States Depart- suming human foods derived from ment of Agriculture pursuant to the those food-producing animals), prior to Federal Food, Drug, and Cosmetic Act, January 1, 1958. the Poultry Products Inspection Act, (g) The word substance in the defini- or the Meat Inspection Act. tion of the term food additive includes a (m) Food includes human food, sub- food or feed or a component of a food or stances migrating to food from food- feed consisting of one or more ingredi- contact articles, pet food, and animal ents. (h) Scientific procedures include the feed. application of scientific data (includ- (n) Food-producing animal means an ing, as appropriate, data from human, animal used to produce human food. animal, analytical, or other scientific [41 FR 38644, Sept. 10, 1976, as amended at 42 studies), information, and methods, FR 55206, Oct. 14, 1977; 81 FR 55051, Aug. 17, whether published or unpublished, as 2016]

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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 set forth in the above-mentioned publi- in the processed food when ready to eat cations will apply to any substance is higher than the tolerance prescribed that may properly be classified as a for the raw agricultural commodity, food additive as defined in section the processed food is adulterated unless 201(s) of the act. the higher concentration is permitted (b) Upon written request describing by a tolerance obtained under section 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 (GRAS). for the raw agricultural commodity, 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 the case of a substance used in food § 570.20 General principles for evalu- prior to January 1, 1958, through expe- ating the safety of food additives. rience based on common use in food. (a) In reaching a decision on any pe- General recognition of safety requires tition filed under section 409 of the act, common knowledge throughout the sci- the Commissioner will give full consid- entific community knowledgeable eration to the specific biological prop- about the safety of substances directly erties of the compound and the ade- or indirectly added to food that there quacy of the methods employed to is reasonable certainty that the sub- demonstrate safety for the proposed stance is not harmful to either the tar- use, and the Commissioner will be get animal or to humans consuming guided by the principles and procedures human food derived from food-pro- for establishing the safety of food addi- ducing animals under the conditions of tives stated in current publications of its intended use (see § 570.3(i)).

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(b) General recognition of safety pendent source that confirms the his- based upon scientific procedures shall tory and circumstances of use of the require the same quantity and quality substance. The information used to of scientific evidence as is required to document and to corroborate the his- obtain approval of a food additive. Gen- tory and circumstances of use of the eral recognition of safety through sci- substance must be generally available; entific procedures shall address safety that is, it must be widely available in for both the target animal and for hu- the country in which the history of use mans consuming human food derived has occurred and readily available to from food-producing animals and shall interested qualified experts in the be based upon the application of gen- United States. A person who concludes erally available and accepted scientific that a use of a substance is GRAS data, information, or methods, which through experience based on its com- ordinarily are published, as well as the mon use in food outside of the United application of scientific principles, and States should notify FDA of that view may be corroborated by the application in accordance with subpart E of this of unpublished scientific data, informa- part. tion, or methods. (d) The food ingredients listed as (c)(1) General recognition of safety GRAS in part 582 of this chapter or af- through experience based on common firmed as GRAS in part 584 of this use in food prior to January 1, 1958, chapter do not include all substances shall address safety for both the target that are generally recognized as safe animal and for humans consuming for their intended use in food. Because human food derived from food-proof the large number of substances the ducing animals and may be achieved intended use of which results or may without the quantity or quality of sci- reasonably be expected to result, di- entific procedures required for ap- rectly or indirectly, in their becoming proval of a food additive. General rec- a component or otherwise affecting the ognition of safety through experience characteristics of food, it is impracti- based on common use in food prior to cable to list all such substances that January 1, 1958, shall be based solely on are GRAS. A food ingredient of natural food use of the substance in the same biological origin that has been widely animal species prior to January 1, 1958, consumed for its nutrient properties in and shall ordinarily be based upon gen- the United States prior to January 1, erally available data and information. 1958, without known detrimental ef- An ingredient not in common use in fects, which is subject only to conven- food prior to January 1, 1958, may tional processing as practiced prior to achieve general recognition of safety January 1, 1958, and for which no only through scientific procedures. (2) A substance used in food prior to known safety hazard exists, will ordi- January 1, 1958, may be generally rec- narily be regarded as GRAS without ognized as safe through experience specific inclusion in part 582 or part 584 based on its common use in food when of this chapter. that use occurred exclusively or pri- (e) A food ingredient that is not marily outside of the United States if GRAS or subject to a prior sanction re- the information about the experience quires a food additive regulation pro- establishes that the substance is safe mulgated under section 409 of the act under the conditions of its intended use before it may be directly or indirectly within the meaning of section 201(u) of added to food. the Federal Food, Drug, and Cosmetic (f) A food ingredient that is listed as Act (see also § 570.3(i)) for both the tar- GRAS in part 582 of this chapter shall get animal and for humans consuming be regarded as GRAS only if, in addi- human food derived from food-pro- tion to all the requirements in the ap- ducing animals. Common use in food plicable regulation, it also meets all of prior to January 1, 1958, that occurred the following requirements: outside of the United States shall be (1) It complies with any applicable documented by published or other in- specifications, or in the absence of such formation and shall be corroborated by specifications, shall be of a purity suit- information from a second, inde- able for its intended use.

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(2) It performs an appropriate func- § 570.35 Affirmation of generally recog- tion in the food or food-contact article nized as safe (GRAS) status. in which it is used. (a) The Commissioner, on his own (3) It is used at a level no higher than initiative, may affirm that a substance necessary to achieve its intended pur- that directly or indirectly becomes a pose in that food or, if used as a compo- component of food is GRAS under the nent of a food-contact article, at a conditions of its intended use. level no higher than necessary to (b)(1) If the Commissioner proposes achieve its intended purpose in that ar- on his own initiative that a substance ticle. is entitled to affirmation as GRAS (g) New information may at any time under the conditions of its intended require reconsideration of the GRAS use, he will place all of the data and in- status of a food ingredient. Any change formation on which he relies on public in status shall be accomplished pursu- file in the office of the Division of ant to § 570.38. Dockets Management and will publish (h) If a substance is affirmed as in the FEDERAL REGISTER a notice giv- GRAS pursuant to § 570.35 and listed in ing the name of the substance, its pro- a regulation with no limitation other posed uses, and any limitations pro- than good manufacturing practice, it posed for purposes other than safety. shall be regarded as GRAS if its condi- (2) The FEDERAL REGISTER notice will tions of use are not significantly dif- allow a period of 60 days during which ferent from those reported in the regu- any interested person may review the lation as the basis on which the GRAS data and information and/or file com- status of the substance was affirmed. If ments with the Division of Dockets the conditions of use are significantly Management. Copies of all comments different, such use of the substance received shall be made available for ex- may not be GRAS. In such case a man- amination in the Division of Dockets ufacturer may not rely on the regula- Management’s office. tion as authorizing the use but must (3) The Commissioner will evaluate independently establish that the use is all comments received. If he concludes GRAS or must use the substance in ac- that there is convincing evidence that cordance with a food additive regula- the substance is GRAS under the con- tion. ditions of its intended use as described (i) If an ingredient is affirmed as in § 570.30, he will publish a notice in GRAS pursuant to § 570.35 and listed in the FEDERAL REGISTER listing the a regulation with specific limitation(s), GRAS conditions of use in this sub- it may be used in food only within such chapter E. limitation(s) (including the category of (4) If, after evaluation of the com- food(s), the functional use(s) of the in- ments, the Commissioner concludes gredient, and the level(s) of use). Any that there is a lack of convincing evi- use of such an ingredient not in full dence that the substance is GRAS compliance with each such established under the conditions of its intended use limitation shall require a food additive and that it should be considered a food regulation. additive subject to section 409 of the (j) Pursuant to § 570.35, a food ingre- Federal Food, Drug, and Cosmetic Act, dient may be affirmed as GRAS and he shall publish a notice thereof in the listed in a regulation for a specific FEDERAL REGISTER in accordance with use(s) without a general evaluation of § 570.38. use of the ingredient. In addition to the [41 FR 38644, Sept. 10, 1976, as amended at 42 use(s) specified in the regulation, other FR 4717, Jan. 25, 1977; 42 FR 15675, Mar. 22, uses of such an ingredient may also be 1977; 42 FR 55207, Oct. 10, 1977; 50 FR 7517, GRAS. Any affirmation of GRAS status Feb. 22, 1985; 50 FR 16668, Apr. 26, 1985; 54 FR for a specific use(s), without a general 18281, Apr. 28, 1989; 62 FR 40600, July 29, 1997; 81 FR 55052, Aug. 17, 2016] evaluation of use of the ingredient, is subject to reconsideration upon such § 570.38 Determination of food addi- evaluation. tive status. [42 FR 55206, Oct. 14, 1977, as amended at 81 (a) The Commissioner may, in ac- FR 55052, Aug. 17, 2016] cordance with § 570.35(b)(4), publish a

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notice in the FEDERAL REGISTER deter- (4) It may adopt any combination of mining that a substance is not GRAS the above three approaches for dif- under the conditions of its intended use ferent uses or levels of use of the addi- and is a food additive subject to section tive. 409 of the Federal Food, Drug, and Cos- (d) If the Commissioner of Food and metic Act. Drugs is aware of any prior sanction (b)(1) The Commissioner, on his own for use of the substance, he will con- initiative or on the petition of any in- currently propose a separate regulation terested person, pursuant to part 10 of covering such use of the ingredient this chapter, may issue a notice in the under this subchapter E. If the Com- FEDERAL REGISTER proposing to deter- missioner is unaware of any such appli- mine that a substance is not GRAS and cable prior sanction, the proposed regu- is a food additive subject to section 409 lation will so state and will require any of the act. Any petition shall include person who intends to assert or rely on all relevant data and information of such sanction to submit proof of its ex- the type described in § 571.130(b) of this istence. Any regulation promulgated chapter. The Commissioner will place pursuant to this section constitutes a all of the data and information on determination that excluded uses which he relies on public file in the Di- would result in adulteration of the food vision of Dockets Management and will in violation of section 402 of the act, include in the FEDERAL REGISTER no- and the failure of any person to come tice the name of the substance, its forward with proof of such an applica- known uses, and a summary of the ble prior sanction in response to the basis for the determination. proposal will constitute a waiver of the (2) The FEDERAL REGISTER notice will right to assert or rely on such sanction allow a period of 60 days during which at any later time. The notice will also any interested person may review the constitute a proposal to establish a data and information and/or file com- regulation under this subchapter E., in- ments with the Division of Dockets corporating the same provisions, in the Management. Copies of all comments event that such a regulation is deter- shall be made available for examina- mined to be appropriate as a result of tion in the Division of Dockets Man- submission of proof of such an applica- agement. ble prior sanction in response to the (3) The Commissioner will evaluate proposal. all comments received. If he concludes that there is a lack of convincing evi- [41 FR 38644, Sept. 10, 1976, as amended at 42 dence that the substance is GRAS or is FR 4717, Jan. 25, 1977; 42 FR 15675, Mar. 22, otherwise exempt from the definition 1977; 42 FR 55207, Oct. 14, 1977; 54 FR 18281, of a food additive in section 201(s) of Apr. 28, 1989; 81 FR 55052, Aug. 17, 2016] the act, he will publish a notice thereof in the FEDERAL REGISTER. If he con- Subparts C–D [Reserved] cludes that there is convincing evidence that the substance is GRAS, he Subpart E—Generally Recognized will publish an order in the FEDERAL as Safe (GRAS) Notice REGISTER listing the substance in this subchapter E as GRAS. (c) A FEDERAL REGISTER notice deter- SOURCE: 81 FR 55052, Aug. 17, 2016, unless mining that a substance is a food addi- otherwise noted. tive shall provide for the use of the ad- § 570.203 Definitions. ditive in food or food-contact surfaces as follows: The definitions and interpretations (1) It may promulgate a food additive of terms in § 570.3 apply to such terms regulation governing use of the addi- when used in this subpart. The fol- tive. lowing definitions also apply: (2) It may promulgate an interim Amendment means any data and infor- food additive regulation governing use mation that you submit regarding a of the additive. filed GRAS notice before we respond to (3) It may require discontinuation of your notice by letter in accordance the use of the additive. with § 570.265(b)(1) or cease to evaluate

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your notice in accordance with (b) When you submit your GRAS no- § 570.265(b)(3). tice, you may do so either in an elec- GRAS means generally recognized as tronic format that is accessible for our safe. evaluation or on paper. If you send GRAS notice means a submission that your GRAS notice on paper, a single informs us of your view that a sub- paper copy is sufficient. stance is not subject to the premarket approval requirements of the Federal § 570.215 Incorporation into a GRAS Food, Drug, and Cosmetic Act based on notice. your conclusion that the substance is You may incorporate into your GRAS under the conditions of its in- GRAS notice either specifically identi- tended use in accordance with § 570.30. fied data and information that you pre- Notified substance means the sub- viously submitted to the Center for stance that is the subject of your Veterinary Medicine (CVM), or specifi- GRAS notice. cally identified publicly available data Notifier means the person (e.g., an in- and information submitted by another dividual, partnership, corporation, as- party, when such data and information sociation, or other legal entity) who is remain in CVM’s records, such as data responsible for the GRAS notice, even and information contained in a pre- if another person (such as an attorney, vious GRAS notice or a food additive agent, or qualified expert) prepares or submits the notice or provides an opin- petition. ion about the basis for a conclusion of § 570.220 General requirements appli- GRAS status. cable to a GRAS notice. Qualified expert means an individual who is qualified by scientific training (a) A GRAS notice has seven parts as and experience to evaluate the safety required by §§ 570.225 through 570.255. of substances under the conditions of You must submit the data and infor- their intended use in animal food. mation specified in each of these parts Supplement means any data and infor- on separate pages or sets of pages. mation that you submit regarding a (b) You must include each of the filed GRAS notice after we respond to seven parts in your GRAS notice. If your notice by letter in accordance you do not include a part, you must in- with § 570.265(b)(1) or cease to evaluate clude with your GRAS notice an expla- your notice in accordance with nation of why that part does not apply § 570.265(b)(3). to your GRAS notice. We, our, and us refer to the United States Food and Drug Administration § 570.225 Part 1 of a GRAS notice: (FDA). Signed statements and certification. You and your refer to a notifier. (a) Part 1 of your GRAS notice must be dated and signed by a responsible of- § 570.205 Opportunity to submit a GRAS notice. ficial of your organization, or by your attorney or agent. Any person may notify FDA of a view (b) Except as required by paragraph that a substance is not subject to the (c)(8) of this section, you must not in- premarket approval requirements of clude any information that is trade se- section 409 of the Federal Food, Drug, cret or confidential commercial infor- and Cosmetic Act based on that per- mation in Part 1 of your GRAS notice. son’s conclusion that the substance is GRAS under the conditions of its in- (c) In Part 1 of your GRAS notice, tended use. you must: (1) Inform us that you are submitting § 570.210 How to send your GRAS no- a GRAS notice in accordance with this tice to FDA. subpart; (a) Send your GRAS notice to the Di- (2) Provide the name and address of vision of Animal Feeds (HFV–220), Cen- your organization; ter for Veterinary Medicine, Food and (3) Provide the name of the notified Drug Administration, 7519 Standish substance, using an appropriately de- Pl., Rockville, MD 20855. scriptive term;

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(4) Describe the intended conditions plete, representative, and balanced of use of the notified substance, includ- submission that includes unfavorable ing stating whether the substance will information, as well as favorable infor- be added to food (including drinking mation, known to you and pertinent to water) for animals in which the sub- the evaluation of the safety and GRAS stance will be used; identifying the status of the use of the substance; and foods to which it will be added, the lev- (10) State both the name and the po- els of use in such foods, and the animal sition or title of the person who signs species for which these foods are in- the GRAS notice. tended (including, when appropriate, a description of a subpopulation expected § 570.230 Part 2 of a GRAS notice: to consume the notified substance); Identity, method of manufacture, specifications, and physical or tech- and the purposes for which the sub- nical effect. stance will be used; (5) Inform us of the statutory basis In Part 2 of your GRAS notice, you for your conclusion of GRAS status must include: (i.e., through scientific procedures in (a) Scientific data and information that identifies the notified substance. accordance with § 570.30(a) and (b) or (1) Examples of appropriate data and through experience based on common information include the chemical use in animal food in accordance with name, applicable registry numbers § 570.30(a) and (c)); (such as a Chemical Abstracts Service (6) State your view that the notified (CAS) registry number or an Enzyme substance is not subject to the pre- Commission (EC) number), empirical market approval requirements of the formula, structural formula, quan- Federal Food, Drug, and Cosmetic Act titative composition, and char- based on your conclusion that the noti- acteristic properties. fied substance is GRAS under the con- (2) When the source of a notified sub- ditions of its intended use; stance is a biological material, you (7) State that, if we ask to see the must include data and information suf- data and information that are the basis ficient to identify: for your conclusion of GRAS status, ei- (i) The taxonomic source (e.g., genus, ther during or after our evaluation of species), including as applicable data your notice, you will: and information at the sub-species (i) Agree to make the data and infor- level (e.g., variety, strain); mation available to us; and (ii) The part of any plant or animal (ii) Agree to both of the following used as the source; and procedures for making the data and in- (iii) Any known toxicants that could formation available to us: be in the source; (A) Upon our request, you will allow (b) A description of the method of us to review and copy the data and in- manufacture of the notified substance formation during customary business in sufficient detail to evaluate the hours at the address you specify for safety of the notified substance as where these data and information will manufactured; be available to us; and (c) Specifications for material that is (B) Upon our request, you will proof appropriate grade for use in animal vide us with a complete copy of the food; and data and information either in an elec- (d) When necessary to demonstrate tronic format that is accessible for our safety, relevant data and information evaluation or on paper; bearing on the physical or other tech- (8) State your view as to whether any nical effect the notified substance is of the data and information in Parts 2 intended to produce, including the through 7 of your GRAS notice are ex- quantity of the notified substance re- empt from disclosure under the Free- quired to produce such effect. dom of Information Act, 5 U.S.C. 552 (e.g., as trade secret or as commercial § 570.235 Part 3 of a GRAS notice: Tar- or financial information that is privi- get animal and human exposures. leged or confidential); In part 3 of your GRAS notice, you (9) Certify that, to the best of your must provide data and information knowledge, the GRAS notice is a com- about exposure to the target animal

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and to humans consuming human food humans may be exposed to in edible derived from food-producing animals, animal tissues. regardless of whether your conclusion of GRAS status is through scientific § 570.240 Part 4 of a GRAS notice: Self- procedures or through experience based limiting levels of use. on common use in food, as follows: In circumstances where the amount (a) For exposure to the target ani- of the notified substance that can be mal, you must provide: added to animal food is limited because (1) The amount of the notified sub- animal food containing levels of the stance that different target animal spe- notified substance above a particular cies are likely to consume in the ani- level would become unpalatable or mal food (including drinking water) as technologically impractical, in Part 4 part of the animal’s total diet, includ- of your GRAS notice you must include ing the intended use and all other data and information on such self-lim- sources in the total diet; and iting levels of use. (2) When applicable, the amount of any other substance that is expected to § 570.245 Part 5 of a GRAS notice: Ex- perience based on common use in be formed in or on food because of the food before 1958. use of the notified substance (e.g., hydrolytic products or reaction prod- If the statutory basis for your con- ucts); clusion of GRAS status is through ex- (3) When applicable, the amount of perience based on common use in ani- any other substance that is present mal food, in Part 5 of your GRAS no- with the notified substance either nat- tice you must include evidence of a urally or due to its manufacture (e.g., substantial history of consumption of contaminants or by-products); the notified substance for food use by a significant number of animals of the (4) The data and information you rely species to which the substance is in- on to establish the amount of the noti- tended to be fed prior to January 1, fied substance and the amounts of any 1958, and evidence of a substantial his- other substance in accordance with tory of consumption by humans con- paragraphs (a)(1) through (a)(3) of this suming human foods derived from food- section that different target animal producing animals prior to January 1, species are likely to consume in the 1958. animal food (including drinking water) as part of the animal’s total diet; and § 570.250 Part 6 of a GRAS notice: Nar- (b) When the intended use is in food rative. for food-producing animals, you must In Part 6 of your GRAS notice, you provide: must include a narrative that provides (1) The potential quantities of any the basis for your conclusion of GRAS residues that humans may be exposed status, in which: to in edible animal tissues, including: (a)(1) You must explain why the data (i) Residues of the notified substance; and information in your notice provide (ii) Residues of any other substance a basis for your view that the notified that is expected to be formed in or on substance is safe under the conditions the animal food because of the use of of its intended use for both the target the notified substance; and animal and for humans consuming (iii) Residues from any other subhuman food derived from food-pro- stance that is present with the notified ducing animals. In your explanation, substance whether naturally, due to its you must address the safety of the no- manufacture (e.g., contaminants or by- tified substance, considering all animal products), or produced as a metabolite food (including drinking water) as part in edible animal tissues when the noti- of the animal’s total diet, taking into fied substance is consumed by a food- account any chemically or pharma- producing animal; and cologically related substances in such (2) The data and information you rely diet. In your explanation, you must on to establish, in accordance with also address the safety of the notified paragraph (b)(1) of this section, the po- substance in regard to human expo- tential quantities of any residues that sure, considering all dietary sources

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and taking into account any chemi- in Part 6 of your GRAS notice to pro- cally or pharmacologically related sub- vide a basis for your view that the no- stances; tified substance is safe under the condi- (2) In your explanation, you must tions of its intended use as described in identify what specific data and infor- accordance with § 570.250(a)(1). mation that you discuss in accordance (b) You must specify which data and with paragraph (a)(1) of this section are information that you list in accordance generally available, and what specific with paragraph (a) of this section are data and information that you discuss generally available, and which data in accordance with paragraph (a)(1) of and information are not generally this section are not generally avail- available. able, by providing citations to the list of data and information that you in- § 570.260 Steps you may take before clude in Part 7 of your GRAS notice in FDA responds to your GRAS notice. accordance with § 570.255; (a) You may submit a timely amend- (b) You must explain how the gen- ment to your filed GRAS notice, to up- erally available data and information date your GRAS notice or in response that you rely on to establish safety in to a question from us, before we re- accordance with paragraph (a) of this spond to your notice by letter in ac- section provide a basis for your conclu- cordance with § 570.265(b)(1) or cease to sion that the notified substance is gen- evaluate your notice in accordance erally recognized, among qualified ex- with § 570.265(b)(3). perts, to be safe under the conditions of (b) At any time before we respond to its intended use for both the target your notice by letter in accordance animal and for humans consuming with § 570.265(b)(1), you may request in human food derived from food-pro- writing that we cease to evaluate your ducing animals; GRAS notice. Your request does not (c) You must either: preclude you from submitting a future (1) Identify, discuss, and place in con- GRAS notice in accordance with this text, data and information that are, or subpart with respect to the notified may appear to be, inconsistent with substance. your conclusion of GRAS status, regardless of whether those data and in- § 570.265 What FDA will do with a formation are generally available; or GRAS notice. (2) State that you have reviewed the (a)(1) We will conduct an initial eval- available data and information and are uation of your submission to determine not aware of any data and information whether to file it as a GRAS notice for that are, or may appear to be, incon- evaluation of your view that the noti- sistent with your conclusion of GRAS fied substance is GRAS under the con- status; ditions of its intended use. (d) If you view any of the data and in- (2) If we file your submission as a formation in your notice as exempt GRAS notice, we will send you a letter from disclosure under the Freedom of that informs you of the date of filing. Information Act, you must identify the (3) If we do not file your submission specific data and information; and as a GRAS notice, we will send you a (e) For non-public, safety-related letter that informs you of that fact and data and information considered in provide our reasons for not filing the reaching a conclusion of GRAS status, submission as a GRAS notice. you must explain how there could be a (4) We will consider any timely basis for a conclusion of GRAS status amendment that you submit to a filed if qualified experts do not have access GRAS notice, to update your GRAS no- to such data and information. tice or in response to a question from us, before we respond to you by letter § 570.255 Part 7 of a GRAS notice: List in accordance with paragraph (b)(1) of of supporting data and information this section, if we deem that doing so is in your GRAS notice. feasible within the timeframes estab- (a) In part 7 of your GRAS notice, lished in paragraph (b) of this section. you must include a list of all of the If we deem that considering your data and information that you discuss amendment is not feasible within the

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timeframes established in paragraph § 570.280 Submission of a supplement. (b) of this section or if we have granted If circumstances warrant, you may your request to cease to evaluate your submit a supplement to a filed GRAS notice, we will inform you that we are notice after we respond to your notice not considering your amendment. by letter in accordance with (b)(1) Within 180 days of filing, we § 570.265(b)(1) or cease to evaluate your will respond to you by letter based on notice in accordance with § 570.265(b)(3). our evaluation of your notice. We may extend the 180 day timeframe by 90 PART 571—FOOD ADDITIVE days on an as needed basis. PETITIONS (2) If we extend the timeframe, we will inform you in writing of the exten- Subpart A—General Provisions sion as soon as practicable but no later than within 180 days of filing. Sec. 571.1 Petitions. (3) If you ask us to cease to evaluate 571.6 Amendment of petition. your GRAS notice in accordance with 571.7 Withdrawal of petition without preju- § 570.260(b), we will send you a letter in- dice. forming you of our decision regarding your request. Subpart B—Administrative Actions on (c) If circumstances warrant, we will Applications send you a subsequent letter about the 571.100 Regulation based on petition. notice. 571.102 Effective date of regulation. 571.110 Procedure for objections and hear- § 570.275 Public disclosure of a GRAS ings. notice. 571.115 Application of the cancer clause of section 409 of the act. (a) The data and information in a 571.130 Procedure for amending and repeal- GRAS notice (including data and infor- ing tolerances or exemptions from toler- mation submitted in any amendment ances. or supplement to your GRAS notice, or AUTHORITY: 21 U.S.C. 321, 342, 348, 371; 42 incorporated into your GRAS notice) U.S.C. 241. are: SOURCE: 41 FR 38647, Sept. 10, 1976, unless (1) Considered a mandatory, rather otherwise noted. than voluntary, submission for purposes of their status under the Free- Subpart A—General Provisions dom of Information Act and our public information requirements in part 20 of § 571.1 Petitions. this chapter; and (a) Petitions to be filed with the (2) Available for public disclosure in Commissioner under the provisions of accordance with part 20 of this chapter section 409(b) of the act shall be sub- as of the date that we receive your mitted in triplicate. If any part of the GRAS notice. material submitted is in a foreign lan- (b) We will make the following read- guage, it shall be accompanied by an ily accessible to the public: accurate and complete English trans- (1) A list of filed GRAS notices, in- lation. The petition shall state peti- cluding the information described in tioner’s post office address to which § 570.225(c)(2) through (c)(5); published notices or orders issued or objections filed pursuant to section 409 (2) The text of any letter that we of the act may be sent. issue under § 570.265(b)(1) or (c); and (b) Pertinent information may be in- (3) The text of any letter that we corporated in, and will be considered as issue under § 570.265(b)(3) if we grant part of, a petition on the basis of spe- your request that we cease to evaluate cific reference to such information sub- your notice. mitted to and retained in the files of (c) We will disclose all remaining the Food and Drug Administration. data and information that are not ex- However, any reference to unpublished empt from public disclosure in accord- information furnished by a person ance with part 20 of this chapter. other than the applicant will not be

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considered unless use of such informa- plete chemical name, using structural for- tion is authorized in a written state- mulas when necessary for specific identifica- ment signed by the person who sub- tion. If any proprietary preparation is used mitted it. Any reference to published as a component, the proprietary name should be followed by a complete quantitative information offered in support of a statement of composition. Reasonable alter- food-additive petition should be accom- natives for any listed substance may be spec- panied by reprints or photostatic cop- ified. ies of such references. If the petitioner does not himself perform (c) Petitions shall include the fol- all the manufacturing, processing, and pack- lowing data and be submitted in the ing operations for a food additive, the peti- following form: tion shall identify each person who will perform a part of such operations and designate (Date) the part. Name of petitioner lllllllllllll The petition shall include stability data, Post office address lllllllllllll and, if the data indicate that it is needed to Date lllllllllllllllllllll ensure the identity, strength, quality, or pu- Name of food additive and proposed use ll rity of the additive, the expiration date that will be employed. B. The amount of the food additive proposed for use and the purposes for which it is Food and Drug Administration proposed, together with all directions, rec- CENTER FOR VETERINARY MEDICINE, ommendations, and suggestions regarding Director, Division of Animal Feeds (HFV–220), the proposed use, as well as specimens of the 7500 Standish Pl., Rockville, MD 20855. labeling proposed for the food additive and DEAR SIRS: The undersigned, llll 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 of the use of the food additive. If the additive Cosmetic Act with respect to llllllll 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 C. Data establishing that the food additive the method of manufacture and the analyt- will have the intended physical or other ical controls used during the various stages technical effect or that it may reasonably be of manufacturing, processing, or packing of expected to become a component, or to affect the food additive which are relied upon to es- the characteristics, directly or indirectly, of tablish that it is a substance of reproducible food and the amount necessary to accom- composition. Alternative methods and con- plish this. These data should include infor- trols and variations in methods and controls mation in sufficient detail to permit evalua- within reasonable limits that do not affect tion with control data. the characteristics of the substance or the D. A description of practicable methods to reliability of the controls may be specified. determine the amount of the food additive in If the food additive is a mixture of chemi- the raw, processed, and/or finished food and cals, the petition shall supply a list of all of any substance formed in or on such food substances used in the synthesis, extraction, because of its use. The test proposed shall be or other method of preparation, regardless of one that can be used for food-control pur- whether they undergo chemical change in poses and that can be applied with consistent the process. Each substance should be identi- results by any properly equipped and trained fied by its common English name and com- laboratory personnel.

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E. Full reports of investigations made with tains the manufacturer’s written per- respect to the safety of the food additive. mission to do so. The manufacturer (A petition may be regarded as incomplete may authorize specific reference to the unless it includes full reports of adequate data without disclosure to the peti- tests reasonably applicable to show whether or not the food additive will be safe for its tioner. Nothing herein shall prevent intended use. The reports ordinarily should reference to published data. 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 readily understood. reports of investigations that would bias an (h)(1) The following data and infor- evaluation of the safety of the food additive.) 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 ex- petition is published in the FEDERAL isting regulation issued pursuant to section REGISTER or, if the petition is not 409(c)(1)(A) of the act, full information on promptly filed because of deficiencies each proposed change that is to be made in in it, after the petitioner is informed the original regulation must be submitted. 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 and information submitted with or in- the variations provided for in the original corporated by reference in the petition. petition and the regulation issued on the (ii) A protocol for a test or study, un- basis of the original petition. less it is shown to fall within the ex- H. The petitioner is required to submit either 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. (iii) Adverse reaction reports, prod- Yours very truly, uct experience reports, consumer com- Petitioner llll plaints, and other similar data and in- By llll formation, after deletion of: (Indicate authority) (a) Names and any information that (d) The petitioner will be notified of would identify the person using the the date on which his petition is filed, product. and an incomplete petition, or one that (b) Names and any information that has not been submitted in triplicate, would identify any third party involved will usually be retained but not filed as with the report, such as a physician or a petition under section 409 of the act. hospital or other institution. The petitioner will be notified in what (iv) A list of all ingredients contained respects his petition is incomplete. in a food additive, whether or not it is (e) The petition must be signed by in descending order of predominance. A the petitioner or by his attorney or particular ingredient or group of ingre- agent, or (if a corporation) by an au- dients shall be deleted from any such thorized official. list prior to public disclosure if it is (f) The data specified under the sev- shown to fall within the exemption es- eral lettered headings should be sub- tablished in § 20.61 of this chapter, and mitted on separate sheets or sets of a notation shall be made that any such sheets, suitably identified. If such data ingredient list is incomplete. have already been submitted with an (v) An assay method or other analyt- earlier application, the present peti- ical method, unless it serves no regu- tion may incorporate it by specific ref- latory or compliance purpose and is erence to the earlier. If part of the data shown to fall within the exemption es- have been submitted by the manufac- tablished in § 20.61 of this chapter. turer of the food additive as a master (2) The following data and informa- file, the petitioner may refer to the tion in a food additive petition are not master file if and to the extent he ob- available for public disclosure unless

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they have been previously disclosed to (2) The Commissioner will publish in the public as defined in § 20.81 of this the FEDERAL REGISTER within 30 days chapter or they relate to a product or from the date of filing of such petition, ingredient that has been abandoned a notice of the filing, the name of the and they no longer represent a trade petitioner, and a brief description of 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

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Commissioner under section 409(b) of (b) At any time before the order pro- the act shall include, with respect to vided for in § 571.100(a) has been for- each study, either a statement that the warded to the FEDERAL REGISTER for study was conducted in compliance publication, the petitioner may with- with the requirements set forth in part draw the petition without prejudice to 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. scribing the conditions under which In such cases, if the Commissioner de- the food additive may be safely used termines that the additional informa- (including, but not limited to, speci- tion or data amounts to a substantive fications as to the particular food or amendment, the petition as amended 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 deny the petition, and shall notify the [41 FR 38647, Sept. 10, 1976, as amended at 50 petitioner of such order and of the rea- FR 7518, Feb. 22, 1985; 50 FR 16668, Apr. 26, sons for such action. 1985] (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 by written notice to the petitioner ex- (a) In some cases the Commissioner tend the 90-day period for not more will notify the petitioner that the peti- than 180 days after the filing of the pe- tion, while technically complete, is in- tition. adequate to justify the establishment of a regulation or the regulation re- § 571.102 Effective date of regulation. quested by petitioner. This may be due 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 Objections and hearings relating to the date of refiling. food additive regulations under section

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409(c), (d), or (h) of the act shall be gov- 573.180 Anhydrous ammonia. erned by part 12 of this chapter. 573.200 Condensed animal protein hydrolysate. [42 FR 4717, Jan. 25, 1977, as amended at 42 573.210 Benzoic acid. FR 15676, Mar. 22, 1977] 573.220 Feed-grade biuret. 573.225 1,3-Butylene glycol. § 571.115 Application of the cancer 573.240 Calcium periodate. clause of section 409 of the act. 573.260 Calcium silicate. Food additives intended for use as an 573.280 Feed-grade calcium stearate and sodium stearate. ingredient in food for animals that are 573.300 Choline xanthate. raised for food production and that 573.304 Chromium propionate. have the potential to contaminate 573.310 Crambe meal, heat toasted. human food with residues whose con- 573.320 Diammonium phosphate. sumption could present a risk of cancer 573.340 Diatomaceous earth. to people must satisfy the require- 573.360 Disodium EDTA. ments of subpart E of part 500 of this 573.380 Ethoxyquin in animal feeds. chapter. 573.400 Ethoxyquin in certain dehydrated forage crops. [52 FR 49588, Dec. 31, 1987] 573.420 Ethyl cellulose. 573.440 Ethylene dichloride. § 571.130 Procedure for amending and 573.450 Fermented ammoniated condensed repealing tolerances or exemptions whey. from tolerances. 573.460 Formaldehyde. 573.480 Formic acid. (a) The Commissioner, on his own 573.490 Gamma-linolenic acid safflower initiative or on the petition of any in- meal. terested person, pursuant to part 10 of 573.492 Gamma-linolenic acid safflower oil. this chapter, may propose the issuance 573.496 Guanidinoacetic acid. of a regulation amending or repealing a 573.500 Condensed, extracted glutamic acid regulation pertaining to a food additive fermentation product. or granting or repealing an exception 573.520 Hemicellulose extract. 573.530 Hydrogenated corn syrup. for such additive. 573.540 Hydrolyzed leather meal. (b) Any such petition shall include an 573.550 25-hydroxyvitamin D3. assertion of facts, supported by data, 573.560 Iron ammonium citrate. showing that new information exists 573.580 Iron-choline citrate complex. with respect to the food additive or 573.600 Lignin sulfonates. that new uses have been developed or 573.615 Marine microalgae. old uses abandoned, that new data are 573.620 Menadione dimethylpyrimidinol bisulfite. available as to toxicity of the chem- 573.625 Menadione nicotinamide bisulfite. ical, or that experience with the exist- 573.637 Methyl esters of conjugated linoleic ing regulation or exemption may jus- acid (cis-9, trans-11 and trans-10, cis-12- tify its amendment or repeal. New data octadecadienoic acids). shall be furnished in the form specified 573.640 Methyl esters of higher fatty acids. in § 571.1 for submitting petitions. 573.660 Methyl glucoside-coconut oil ester. 573.680 Mineral oil. [42 FR 4717, Jan. 25, 1977; 42 FR 15676, Mar. 22, 573.685 Natamycin. 1977] 573.696 Feed grade sodium formate. 573.700 Sodium nitrite. PART 573—FOOD ADDITIVES PER- 573.720 Petrolatum. 573.740 Odorless light petroleum hydro- MITTED IN FEED AND DRINKING carbons. WATER OF ANIMALS 573.750 Pichia pastoris dried yeast. 573.760 Poloxalene. Subpart A [Reserved] 573.780 Polyethylene. 573.800 Polyethylene glycol (400) mono- and Subpart B—Food Additive Listing dioleate. 573.820 Polyoxyethylene glycol (400) mono- Sec. and dioleates. 573.120 Acrylamide-acrylic acid resin. 573.840 Polysorbate 60. 573.130 Aminoglycoside 3′-phospho- trans- 573.860 Polysorbate 80. ferase II. 573.870 Poly(2-vinylpyridine-co-styrene). 573.140 Ammoniated cottonseed meal. 573.880 Normal propyl alcohol. 573.160 Ammoniated rice hulls. 573.900 Pyrophyllite. 573.170 Ammonium formate. 573.914 Salts of volatile fatty acids.

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573.920 Selenium. aminoglycoside antibiotics, including 573.940 Silicon dioxide. kanamycin, neomycin, and gentamicin. 573.960 Sorbitan monostearate. (b) Aminoglycoside 3′- 573.980 Taurine. 573.1000 Verxite. phosphotransferase II is encoded by the 573.1010 Xanthan gum. kanr gene originally isolated from 573.1020 Yellow prussiate of soda. transposon Tn5 of the bacterium Esch- erichia coli. AUTHORITY: 21 U.S.C. 321, 342, 348. (c) The level of the additive does not SOURCE: 41 FR 38652, Sept. 10, 1976, unless exceed the amount reasonably required otherwise noted. for selection of plant cells carrying the kanr gene along with the genetic mate- Subpart A [Reserved] rial of interest. Subpart B—Food Additive Listing [59 FR 26711, May 23, 1994] § 573.140 Ammoniated cottonseed § 573.120 Acrylamide-acrylic acid meal. resin. Acrylamide-acrylic acid resin The food additive ammoniated cot- (hydrolized polyacrylamide), only for tonseed meal may be safely used in ac- the purposes of this section as de- cordance with the following conditions: scribed below, may be safely used in ac- (a) The food additive is the product cordance with the following prescribed obtained by the treatment of cotton- conditions: seed meal with anhydrous ammonia (a) The additive is produced by po- until a pressure of 50 pounds per square lymerization of acrylamide with par- inch gauge is reached. tial hydrolysis, or by copolymerization (b) It is used or intended for use in of acrylamide and acrylic acid with the the feed of ruminants as a source of greater part of the polymer being com- protein and/or as a source of non- posed of acrylamide units. protein nitrogen in an amount not to (b) The additive meets the following exceed 20 percent of the total ration. specifications: (c) To assure safe use, the label and (1) A minimum molecular weight of 3 labeling of the additive and of any feed million. additive supplement, concentrate, or (2) Viscosity range: 3,000 to 6,000 cen- premix prepared therefrom shall bear, tipoises at 77 °F in a 1 percent aqueous in addition to the other information resolution as determined by LVF Brook- quired by the act, the following: field Viscometer or equivalent using a (1) The name of the additive. number 6 spindle at 20 r.p.m. (2) The maximum percentage of (3) Residual acrylamide: Not more equivalent crude protein from the non- than 0.05 percent. protein nitrogen. (c) It is used as a thickener and sus- (3) Directions for use to provide not pending agent in nonmedicated aque- more than 20 percent of the additive in ous suspensions intended for addition the total ration. to animal feeds. (4) A statement: (i) That not more than one-third of [41 FR 38652, Sept. 10, 1976, as amended at 45 the total protein in the feed should FR 38058, June 6, 1980] come from nonprotein nitrogen § 573.130 Aminoglycoside 3′-phospho- sources. transferase II. (ii) That the additive is not to be given to debilitated or starved animals. The food additive aminoglycoside 3′- (iii) ‘‘Warning—This feed should be phosphotransferase II may be safely used only in accordance with directions used in the development of genetically furnished on the label.’’ modified cotton, oilseed rape, and to- matoes in accordance with the fol- [41 FR 38652, Sept. 10, 1976, as amended at 42 lowing prescribed conditions: 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

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with the following prescribed condi- Cosmetic Act (the act), the label and tions: labeling shall contain: (a) The food additive is the product (1) The name of the additive. obtained by the treatment of ground (2) Adequate directions for use in- rice hulls with monocalcium phosphate cluding a statement that ammonium and anhydrous ammonia at a tempera- formate must be uniformly applied and ture of 350 °F and a pressure of 175 thoroughly mixed into complete swine pounds per square inch. feeds and that the complete swine feeds (b) It is used or intended for use in so treated shall be labeled as con- the feed of beef cattle as a source of taining ammonium formate. crude fiber and as the sole source of (3) Cautions for use including this nonprotein nitrogen in an amount not statement: Caution: Follow label direc- to exceed 20 percent of the total ration. tions. Formic acid and formate salts (c) To assure safe use of the additive, from all added sources cannot exceed the label and labeling of the additive 1.2 percent of complete feed when mul- and of any feed additive supplement, tiple sources of formic acid and its feed additive concentrate, or feed addi- salts are used in combination. tive premix prepared therefrom, shall (e) To ensure safe use of the additive, contain, in addition to other informa- in addition to the other information re- tion required by the act, the following: quired by the Federal Food, Drug, and (1) The name of the additive. Cosmetic Act and paragraph (d) of this (2) The maximum percentage of section, the label and labeling shall equivalent crude protein from the non- contain: protein nitrogen. (1) Appropriate warnings and safety (3) Directions for use to provide not precautions concerning ammonium for- more than 20 percent of the additive in mate (37 percent ammonium salt of for- the total ration, and a prominent mic acid and 62 percent formic acid). statement: ‘‘Warning—This feed should (2) Statements identifying ammo- be used only in accordance with the di- nium formate in formic acid (37 per- rections furnished on the label.’’ cent ammonium salt of formic acid and 62 percent formic acid) as a corrosive § 573.170 Ammonium formate. and possible severe irritant. The food additive, ammonium for- (3) Information about emergency aid mate, may be safely used in the manu- in case of accidental exposure as fol- facture of complete swine feeds in ac- lows: cordance with the following prescribed (i) Statements reflecting require- conditions: ments of applicable sections of the (a) The additive is manufactured by Superfund Amendments and Reauthor- the reaction of 99.5 percent ammonia ization Act (SARA), and the Occupa- gas and 99 percent formic acid in a con- tional Safety and Health Administra- tinuous loop reactor to produce a solution’s (OSHA) human safety guidance tion made up of 37 percent ammonium regulations. salt of formic acid and 62 percent for- (ii) Contact address and telephone mic acid. number for reporting adverse reactions (b) The additive is used or intended or to request a copy of the Material for use as a feed acidifying agent, to Safety Data Sheet (MSDS). lower the pH, in complete swine feeds [75 FR 41725, July 19, 2010, as amended at 78 at levels not to exceed 1.2 percent of FR 42692, July 17, 2013; 82 FR 52209, Nov. 13, the complete feed. 2017] (c) To ensure safe use of the additive, formic acid and formate salts from all § 573.180 Anhydrous ammonia. added sources cannot exceed 1.2 percent (a) The food additive anhydrous am- of complete feed when multiple sources monia is applied directly to corn plant of formic acid and its salts are used in material and thoroughly blended prior combination. to ensiling. It is used or intended for (d) To assure safe use of the additive, use as a source of nonprotein nitrogen in addition to the other information rein cattle feed in accordance with para- quired by the Federal Food, Drug, and graphs (a)(1), (2), or (3) as follows:

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(1)(i) The food additive anhydrous § 573.200 Condensed animal protein ammonia is applied as a component of hydrolysate. an aqueous premix containing 16 to 17 (a) Identity. The condensed animal percent ammonia, with molasses, min- protein hydrolysate is produced from erals, and not less than 83 percent the meat byproducts scraped from crude protein. The premix is a source cured (salted) hides taken from cattle of nonprotein nitrogen and minerals. slaughtered for food consumption. The (ii) In addition to the requirements of meat byproduct is hydrolyzed with paragraph (b) of this section, the label- heat and phosphoric acid. ing shall bear an expiration date of not (b) Specifications. The additive shall more than 10 weeks after date of manu- conform to the following percent-by- facture; a statement that additional weight specifications: protein should not be fed to lactating Moisture, not less than 45 percent nor more dairy cows producing less than 32 than 50 percent. pounds of milk per day nor beef cattle Protein, not less than 24 percent. consuming less than 1 percent of body Salt (NaCl), not more than 15 percent. weight daily in shelled corn; and a Phosphorus, not less than 2.25 percent. warning not to use additional trace (c) Uses. It is used or intended for use mineral supplementation with treated as a source of animal protein, phos- silage. phorus, and salt (NaCl) as follows: (2)(i) The food additive anhydrous (1) In poultry and swine feed in an ammonia is applied directly to corn amount not to exceed 5 percent by plant material for use in dairy or beef weight of the feed. cattle rations. (2) In feed concentrates for cattle in (ii) The anhydrous ammonia is ap- an amount not to exceed 10 percent by plied at a rate not to exceed the equiv- weight of the concentrate. alent of 0.35 percent of the corn plant (d) Labeling. The label and labeling material. shall bear, in addition to the other in- (iii) It is applied to corn plant mate- formation required by the act: rial containing 30 to 35 percent dry (1) The name of the additive, con- matter. densed animal protein hydrolysate. (iv) It is applied so that 75 to 85 per- (2) Adequate directions for use in- cent of the additive is liquid at ambi- cluding maximum quantities permitted ent pressure. for each species and a guaranteed anal- (3)(i) The food additive anhydrous ysis of the additive. ammonia is applied after being diluted to a 15 to 30 percent aqueous ammonia § 573.210 Benzoic acid. solution (by weight). The food additive, benzoic acid, may (ii) The anhydrous ammonia solution be safely used in the manufacture of is applied at a rate not to exceed anhy- complete swine feeds in accordance drous ammonia equivalent to 0.3 per- with the following prescribed condi- cent of the corn plant material. tions: (iii) It is applied to corn plant mate- (a) The additive is used or intended rial containing 28 to 38 percent dry for use as a feed acidifying agent, to matter. lower the pH, in complete swine feeds (iv) The silage treated with aqueous at levels not to exceed 0.5 percent of ammonia is to be fed to dairy cattle the complete feed. only. (b) The additive consists of not less (b) Its labeling shall bear, in addition than 99.5 percent benzoic acid (CAS 65– to the other requirements of the act, 85–0) by weight with the sum of 2- the name of the additive, the con- methylbiphenyl, 3-methylbiphenyl, 4- centration of ammonia, the maximum methylbiphenyl, benzyl benzoate, and percentage of equivalent crude protein isomers of dimethylbiphenyl not to exceed 0.01 percent by weight. from nonprotein nitrogen, and direc- (c) To assure safe use of the additive, tions for use consistent with this sec- in addition to the other information re- tion. quired by the Federal Food, Drug, and [44 FR 40284, July 10, 1979] Cosmetic Act and paragraph (b) of this

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section, the label and labeling shall nitrogen exceed one-third of the total contain: crude protein in the total daily ration. (1) The name of the additive. [41 FR 38652, Sept. 10, 1976, as amended at 68 (2) Adequate directions for use in- FR 27904, May 22, 2003] cluding a statement that benzoic acid must be uniformly applied and thor- § 573.225 1,3-Butylene glycol. oughly mixed into complete swine The food additive 1,3-butylene glycol feeds and that the complete swine feeds (1,3-butanediol) may be safely used in so treated shall be labeled as con- accordance with the following pre- taining benzoic acid. scribed conditions: (3) Appropriate warnings and safety (a) It complies with the specifica- precautions concerning benzoic acid. tions in § 173.220(a) of this chapter. (4) A warning statement identifying (b) It is intended for use in swine feed benzoic acid as a possible irritant. as a source of energy. (5) Information about emergency aid (c) It is to be thoroughly mixed into in case of accidental exposure. feed at levels not to exceed 9 percent of (6) Contact address and telephone the dry matter of the total ration. number for reporting adverse reactions (d) 1,3-Butylene glycol should be or to request a copy of the Material mixed in feed with equipment adapted Safety Data Sheet (MSDS). for the addition of liquids, and the feed should be mixed not less than 5 min- [79 FR 14176, Mar. 13, 2014] utes after its addition. § 573.220 Feed-grade biuret. [53 FR 40061, Oct. 13, 1988] The food additive feed grade biuret § 573.240 Calcium periodate. may be safely used in ruminant feed in accordance with the following pre- The food additive calcium periodate scribed conditions: may be safely used in accordance with (a) The food additive is the product the following prescribed conditions: resulting from the controlled pyrolysis (a) The additive is produced by react- of urea conforming to the following ing calcium iodate with calcium hy- specifications: droxide or calcium oxide to form a substance consisting of not less than 60 Percent percent by weight of penta calcium orthoperiodate containing 28 to 31 per- Biuret ...... 55 minimum. cent by weight of iodine. Urea ...... 15 maximum. Cyanuric acid and triuret ...... 30 maximum. (b) It is used or intended for use in Mineral oil ...... 0.5 maximum. salt for livestock as a source of iodine. Total nitrogen (equivalent to 218.75 pct 35 minimum. crude protein). § 573.260 Calcium silicate. 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 Feed-grade calcium stearate and so- addition to other information required dium stearate may be safely used in an by the act, the following: animal feed in accordance with the fol- (i) The name of the additive. lowing prescribed conditions: (ii) The maximum percentage of (a) Feed-grade calcium stearate and equivalent crude protein from non- sodium stearate are the calcium or so- protein nitrogen. dium salts of a fatty acid mixture that (2) The label shall recommend that is predominately stearic acid. Associ- the diet be balanced to provide ade- ated fatty acids, including palmitic quate nutrients when equivalent crude acid and minor amounts of lauric, protein from all forms of nonprotein myristic, pentadecanoic, margaric,

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arachidic, and other fatty acids may be (2) Hexavalent chromium content, contained in the mixture, but such as- less than 2 parts per million (ppm). sociated fatty acids in aggregate do not (3) Arsenic, less than 1 ppm. exceed 35 percent by weight of the mix- (4) Cadmium, less than 1 ppm. ture. The fatty acids may be derived (5) Lead, less than 0.5 ppm. from feed-grade fats or oils. (6) Mercury, less than 0.5 ppm. (b) The additives meet the following (7) Viscosity, not more than 2,000 specifications: centipoise. (1) Unsaponifiable matter does not (d) The additive shall be incorporated exceed 2 percent. into feed as follows: (2) They are free of chick-edema fac- (1) It shall be incorporated into each tor. ton of complete feed by adding no less (c) The additives are manufactured so than one pound of a premix containing that in aqueous solution they are ex- no more than 181.4 milligrams of added posed for 1 hour or longer to tempera- chromium from chromium propionate ture in excess of 180 °F. per pound. (d) They are used as anticaking (2) The premix manufacturer shall agents in animal feeds in accordance follow good manufacturing practices in with current good manufacturing prac- the production of chromium propionate tices. premixes. Inventory, production, and [63 FR 8573, Feb. 20, 1998] distribution records must provide a complete and accurate history of prod- § 573.300 Choline xanthate. uct production. Choline xanthate may be safely used (3) Chromium from all sources of sup- as a component of animal feed as an plemental chromium cannot exceed: added source of choline to supplement (i) A level of 0.2 ppm in complete feed the diets of poultry, ruminants, and for broiler chickens. swine in accordance with good feeding (ii) An intake of 4 mg per horse per practice. day. (e) To assure safe use of the additive § 573.304 Chromium Propionate. in addition to the other information required by the Federal Food, Drug, and The food additive chromium propio- Cosmetic Act: nate may be safely used in animal feed as a source of supplemental chromium (1) The label and labeling of the addi- in accordance with the following pre- tive, any feed premix, and complete scribed conditions: feed shall contain the name of the ad- (a) The additive is manufactured by ditive. the reaction of a chromium salt with (2) The label and labeling of the addi- propionic acid, at an appropriate stoi- tive and any feed premix shall also con- chiometric ratio, to produce triaqua- tain: (i) A guarantee for added chromium (mu3-oxo) hexakis (mu2-propionato- O,O′) trichromium propionate with the content. empirical formula, (ii) Adequate directions for use and cautions for use including these state- [Cr3(O)(CH3CH2CO2)6(H2O)3]CH3CH2CO2. (b) The additive is added to feed as ments: ‘‘Caution: Follow label direc- follows: tions’’ and consistent with the direc- (1) In complete feed for broiler chick- tions for use, the following: ens at a level not to exceed 0.2 milli- (A) For feed for broiler chickens, grams (mg) of chromium from chro- ‘‘Chromium from all sources of supple- mium propionate per kilogram feed. mental chromium cannot exceed 0.2 (2) In feed for horses at a level not to parts per million of the complete feed exceed an intake of 4 mg of chromium for broiler chickens.’’ from chromium propionate per horse (B) For feed for horses, ‘‘Chromium per day. from all sources of supplemental chro- (c) The additive meets the following mium cannot exceed 4 milligrams per specifications: horse per day.’’ (1) Total chromium content, 8 to 10 [81 FR 35611, June 3, 2016, as amended at 85 percent. FR 14566, Mar. 13, 2020]

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§ 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. a source of protein in an amount not to Arsenic (as As), not more than 20 parts per exceed 4.2 percent of the total ration. million Fluorine, not more than 600 parts per mil- [46 FR 30082, June 5, 1981] lion. § 573.320 Diammonium phosphate. (c) Uses. It is used or intended for use The food additive diammonium phos- as an inert carrier or anticaking agent phate may be safely used in ruminant in animal feeds in an amount not to ex- feed in accordance with the following ceed 2 percent by weight of the total prescribed conditions: ration. (a) The food additive is the product resulting from the neutralization of § 573.360 Disodium EDTA. feeding-phosphoric-acid or The food additive disodium EDTA defluorinated wet-process phosphoric (disodium ethylenediaminetetraace- acid with anhydrous ammonia. It con- tate) may be safely used in animal tains not less than 106.25 percent equiv- feeds, in accordance with the following alent crude protein (nitrogen × 6.25) prescribed conditions: and 20 percent phosphorus. It contains (a) The food additive contains a min- not more than the following: imum of 99 percent disodium ethylene- 1 part fluorine to 100 parts phosphorus. diaminetetraacetate dihydrate 75 parts per million or arsenic (as As). (C10H14O8N2Na2 · 2H2O). 30 parts per million of heavy metals, as lead (b) It is used to solubilize trace min- (Pb). erals in aqueous solutions, which are (b) It is used in ruminant feeds as a then added to animal feeds. source of phosphorus and nitrogen in (c) It is used or intended for use in an an amount that supplies not more than amount not to exceed 240 parts per mil- 2 percent of equivalent crude protein in lion of the additive in finished feed. the total daily ration. (d) To assure safe use of the additive (c) To assure safe use of the additive, the label and labeling shall bear: the label and labeling of the additive (1) The name of the additive; and and that of any feed additive supple- (2) Adequate mixing directions to en- ment, feed additive concentrate, feed sure that the chelated trace-mineral additive premix, or complete feed premix is uniformly blended throughout pared therefrom shall contain, in addi- the feed.

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§ 573.380 Ethoxyquin in animal feeds. White clover (including La- Trifolium repens. dino). Ethoxyquin (1,2-dihydro-6-ethoxy- White sweetclover ...... Melilotus alba. 2,2,4-trimethylquinoline) may be safely Yellow sweetclover ...... Melilotus officinalis. used in animal feeds, when incor- Coastal Bermudagrass ...... Cynodon dactylon. porated therein in accordance with the Corn ...... Zea mays. following prescribed conditions. Fescue ...... Festuca sp. Oats ...... Avena sativa. (a) It is intended for use only: (1) As Orchardgrass ...... Dactylis glomerata. a chemical preservative for retarding Reed canarygrass ...... Pharlaris arundinacea. oxidation of carotene, xanthophylls, Ryegrass (annual and peren- Elymus sp. and Lolium and vitamins A and E in animal feed nial). perenne. and fish food and, (2) as an aid in pre- Sorghums ...... Sorghum vulgare vars, fete- rita, shallu, kaoliang, venting the development of organic broomcorn. peroxides in canned pet food. Sudan grass ...... Sorghum vulgare sudanense. (b) The maximum quantity of the ad- Wheat ...... Triticum aestivum. ditive permitted to be used and to remain in or on the treated article shall or any mixture of such forage crops, for not exceed 150 parts per million. use only as an animal feed. (c) To assure safe use of the additive, (b) Such additive is used only as a the label and labeling of the food addi- chemical preservative for the purpose tive container and that of any inter- of retarding oxidative destruction of mediate premixes prepared therefrom naturally occurring carotenes and vita- shall contain, in addition to other in- min E in the forage crops. formation required by the act: (c) It is added to the dehydrated for- (1) The name of the additive, age crops in an oil mixture containing ethoxyquin. only suitable animal or suitable vege- (2) A statement of the concentration table oil, prior to grinding and mixing. or strength contained therein. (d) The maximum quantity of the ad- (3) Adequate use directions to provide ditive permitted to be used and to re- for a finished article with the proper main in or on the dehydrated forage concentration of the additive as pro- crop shall not exceed 150 parts per mil- vided in paragraph (b) of this section, lion. whether or not intermediate premixes (e) To assure the safe use of the addi- are to be used. tive, the label of the market package (d) The label of any animal feed con- shall contain, in addition to other in- taining the additive shall, in addition formation required by the act: to the other information required by (1) The name of the additive as speci- the act, bear the statement ‘‘Ethoxyquin, a preservative’’ or fied in this section. ‘‘Ethoxyquin added to retard the (2) Directions for the incorporation of oxidative destruction of carotene, the additive in the forage crops, as xanthophylls, and vitamins A and E.’’ specified in paragraph (c) of this section, with the directive that only suit- § 573.400 Ethoxyquin in certain dehy- able animal or suitable vegetable oils drated forage crops. are to be used in the oil mix. Ethoxyquin (1,2-dihydro-6-ethoxy- (f) The label of any dehydrated forage 2,2,4-trimethylquinoline) may be safely crops treated with the additive or the used in the dehydrated forage crops label of an animal-feed supplement listed in paragraph (a) of this section containing such treated forage crops, when incorporated therein in accord- shall, in addition to other information ance with the conditions prescribed in required by the act, bear the following this section: statements: (a) It may be added to dehydrated (1) ‘‘Ethoxyquin, a preservative,’’ or forage prepared from: ‘‘Ethoxyquin added to retard the Alfalfa ...... Medicago sativa. oxidative destruction of carotene and Barley ...... Hordeum vulgare. Clovers: vitamin E.’’ Alsike clover ...... Trifolium hybridum. (2) The statement ‘‘For use in animal Crimson clover ...... Trifolium incarnatum. feed only.’’ Red clover ...... Trifolium pratense.

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§ 573.420 Ethyl cellulose. gen shall not exceed 30 percent of the 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 and equivalent crude protein from all Dockets Management, Food and Drug other added forms of nonprotein nitro- Administration, 5630 Fishers Lane, rm.

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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 not contain more than 25 percent of the percent of the analyzed fat content for mixture. each batch. (2) For soybean and canola seeds and/ (b)(1) The food additive is formalde- or meals to which there may be added hyde (CAS No. 50–00–0; 37 percent aque- vegetable oil as a component of dry, ous solution). It is used at a rate of 5.4 nonpelleted feeds for beef and dairy pounds (2.5 kilograms) per ton of ani- cattle, including lactating dairy cattle. mal feed or feed ingredient. It is an (i) An aqueous blend of oilseed and/or antimicrobial agent used to maintain meals, with or without added vegetable complete animal feeds or feed ingredi- oil, in a ratio such that, on a dry mat- ents Salmonella negative for up to 21 ter basis, the final protein level will be days. 25 to 35 percent and the fat content will (2) To assure safe use of the additive, be 20 to 45 percent. The feed ingredi- in addition to the other information re- ents are those defined by the ‘‘Official quired by the Act, the label and label- Publication’’ of the Association of ing shall contain: American Feed Control Officials, Inc., (i) The name of the additive. 2003 ed., pp. 301, 307, 308, and 309, which (ii) A statement that formaldehyde is incorporated by reference. The Di- solution which has been stored below 40 rector of the Office of the Federal Reg- °F or allowed to freeze should not be ister approves this incorporation by applied to complete animal feeds or reference in accordance with 5 U.S.C. feed ingredients. 552(a) and 1 CFR part 51. You may ob- (iii) Adequate directions for use in- tain copies from the Assistant Sec- cluding a statement that formaldehyde retary-Treasurer, Association of Amer- should be uniformly sprayed on and ican Feed Control Officials Inc., P.O. thoroughly mixed into the complete Box 478, Oxford, IN 47971, or you may animal feeds or feed ingredients and examine a copy at the Division of that the complete animal feeds or feed Dockets Management, Food and Drug ingredients so treated shall be labeled Administration, 5630 Fishers lane, rm. as containing formaldehyde. The label 1061, Rockville, MD 20852, or at the Na- must prominently display the state- tional Archives and Records Adminis- ment: ‘‘Treated with formaldehyde to tration (NARA). For information on maintain feed Salmonella negative. Use the availability of this material at within 21 days.’’ NARA, call 202–741–6030, or go to: http:// (iv) The labeling for feed or feed in- www.archives.gov/federallregister/ gredients to which formaldehyde has

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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 ensure safe use of the additive, within 21 days.’’ formic acid and formate salts from all (3) To assure safe use of the additive, added sources cannot exceed 1.2 percent in addition to the other information re- of complete feed when multiple sources quired by the Act, the label and label- of formic acid and its salts are used in ing shall contain: combination. (i) Appropriate warnings and safety (4) To assure safe use of the additive, precautions concerning formaldehyde. in addition to the other information re- (ii) Statements identifying formalde- quired by the Federal Food, Drug and hyde as a poison with potentials for ad- Cosmetic Act, the label and labeling verse respiratory effects. shall contain: (iii) Information about emergency (i) The name of the additive. aid in case of accidental inhalation. (ii) Adequate directions for use in- (iv) Statements reflecting require- cluding a statement that formic acid ments of applicable sections of the must be uniformly applied and thor- Superfund Amendments and Reauthor- oughly mixed into complete feeds and ization Act (SARA), and the Occupa- that the complete feeds so treated shall tional Safety and Health Administra- be labeled as containing formic acid. tion’s (OSHA) human safety guidance regulations. (iii) Cautions for use including this statement: Caution: Follow label direc- (v) Contact address and phone num- tions. Formic acid and formate salts ber for reporting adverse reactions or from all added sources cannot exceed to request a copy of the Materials Safe- ty Data Sheet (MSDS). 1.2 percent of complete feed when multiple sources of formic acid and its [41 FR 38652, Sept. 10, 1976, as amended at 54 salts are used in combination. FR 18281, Apr. 28, 1989; 61 FR 15704, Apr. 9, (5) To ensure safe use of the additive, 1996; 63 FR 53580, Oct. 6, 1998; 68 FR 65633, in addition to the other information re- Nov. 21, 2003] quired by the Federal Food, Drug, and § 573.480 Formic acid. Cosmetic Act and paragraph (b)(4) of this section, the label and labeling The food additive, formic acid, may shall contain: be safely used in accordance with the (i) Appropriate warnings and safety following conditions: precautions concerning formic acid (85 (a) The additive is used as a preserva- percent formic acid). tive in hay crop silage in an amount (ii) Statements identifying formic not to exceed 2.25 percent of the silage acid (85 percent formic acid) as a corro- on a dry weight basis or 0.45 percent when direct cut, as follows: sive and possible severe irritant. (1) The top foot of silage stored (iii) Information about emergency should not contain formic acid and aid in case of accidental exposure. (2) Silage should not be fed to live- (A) Statements reflecting require- stock within 4 weeks of treatment. ments of applicable sections of the (b) The additive is used or intended Superfund Amendments and Reauthor- for use as a feed acidifying agent, to ization Act (SARA), and the Occupa- lower the pH, in complete feed for tional Safety and Health Administra- swine and poultry at levels not to ex- tion’s (OSHA) human safety guidance ceed 1.2 percent of the complete feed. regulations. (1) The additive consists of not less (B) Contact address and telephone than 85 percent formic acid (CAS 64–18– number for reporting adverse reactions 6). or to request a copy of the Safety Data (2) The additive meets the following Sheet (SDS). specifications: [76 FR 7106, Feb. 9, 2011, as amended at 82 FR (i) Free methyl alcohol not to exceed 52209, Nov. 13, 2017; 83 FR 20, Jan. 2, 2018; 83 1,000 parts per million (ppm); FR 66618, Dec. 27, 2018]

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§ 573.490 Gamma-linolenic acid saf- linolenic acid and other omega-6 fatty flower meal. acids in accordance with the following The food additive consists of the conditions: meal obtained after the removal of (a) The additive is the oil obtained most of the oil from whole seeds or par- from whole seeds and/or partially tially dehulled seeds or both obtained dehulled seeds of a Carthamus tinctorius from a Carthamus tinctorius L. safflower L. safflower Centennial variety geneti- Centennial variety genetically engi- cally engineered to express the delta-6- neered to express the delta-6- desaturase gene from Saprolegnia desaturase gene from Saprolegnia diclina Humphrey. The 453 amino acid, diclina Humphrey. The 453 amino acid, delta-6-desaturase enzyme converts the delta-6-desaturase enzyme converts the fatty acid linoleic acid to gamma-lino- fatty acid linoleic acid to gamma-linolenic acid (all-cis-6,9,12- lenic acid during seed development. octadecatrienoic acid) during seed de- The resulting additive may be safely velopment. used in cattle and poultry feeds in ac- (1) The additive obtained from the cordance with the following prescribed seeds of the genetically engineered saf- conditions: flower Centennial variety may be (a) The additive shall contain not blended with oil obtained from seeds of less than 20 percent crude protein, not non-engineered oleic acid safflower va- more than 40 percent crude fiber, not rieties in order to meet the specifica- more than 10 percent moisture, and not tions required for the additive or the more than 2 percent crude fat. blend in paragraph (a)(2) of this sec- (b) The crude fat in the additive tion. meets the following specifications: (2) The additive or a safflower oil (1) Gamma-linolenic acid content not blend containing the additive for use in to exceed 55 percent. animal food meets the following speci- (2) Total content of stearidonic acid fications: and cis, cis-6, 9-octadecadienoic acid (i) Crude fat content of the additive not to exceed a total of 0.5 percent. or the safflower oil blend is not less (3) Total content of palmitic, stearic, than 99.5 percent. oleic, linoleic, and other associated (ii) Gamma-linolenic acid content is fatty acids to exceed a total of 40 per- between 350 and 450 milligrams (mg) cent. gamma-linolenic acid per gram of the (c) The additive is used or intended additive or the safflower oil blend. for use in cattle and poultry feeds as a (iii) Total content of stearidonic acid source of protein in accordance with and cis, cis-6,9-octadecadienoic acid in good manufacturing and feeding prac- the additive or the safflower oil blend tices. must not exceed a total of 0.3 percent. (d) To assure safe use of the additive, (b) Addition of the additive, or the in addition to the other information re- safflower oil blend, to complete dry quired by the Food, Drug, and Cos- adult maintenance dog food must meet metic Act, the label and labeling of the the following: additive, any feed premix, or complete (1) Addition of the additive or the feed shall bear the following: safflower oil blend cannot provide more (1) The name of the additive or the than 36 mg gamma-linolenic acid per common name, safflower meal. kilogram body weight of the dog per (2) Adequate directions for use in cat- day in more than 86 mg of the additive tle and poultry feeds. or the safflower oil blend. This max- (e) The additive may be identified by imum addition rate of the additive, or the common or usual name, safflower the safflower oil blend, is 0.3 percent of meal. a complete dry adult maintenance dog [80 FR 35569, June 22, 2015] food containing 3,600 kilocalories of metabolizable energy per kilogram of § 573.492 Gamma-linolenic acid saf- food as-fed. flower oil. (2) Adjustments must be made for dif- The food additive, gamma-linolenic fering concentrations of gamma-lino- acid safflower oil, may be safely used lenic acid and for dog food formulas of in animal food as a source of gamma- different caloric density and/or that

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are fed to specific weights, breeds, or [N-(aminoiminomethyl)-glycine] (CAS dogs of different activity levels to meet 352–97–6) by weight. the requirements of this paragraph. (d) The additive meets the following (c) Addition of the additive, or the specifications: safflower oil blend, to complete dry (1) Dicyandiamide not to exceed 0.5 adult maintenance cat food must meet percent; the following: (2) Cyanamide not to exceed 0.01 per- (1) Addition of the additive or the cent; safflower oil blend cannot provide more (3) Melamine not to exceed 15 parts than 33 mg gamma-linolenic acid per per million (ppm); kilogram body weight of the cat per (4) Sum of ammeline, ammelide, and day in more than 79 mg of the additive cyanuric acid not to exceed 35 ppm; and or the safflower oil blend. This max- (5) Water not to exceed 1 percent. imum addition rate of the additive, or (e) To assure safe use of the additive the safflower oil blend, is 0.5 percent of in addition to the other information re- a complete dry adult maintenance cat quired by the Federal Food, Drug, and food containing 4,000 kilocalories of Cosmetic Act: metabolizable energy per kilogram of (1) The label and labeling of the addi- food as-fed. tive, any feed premix, and complete (2) Adjustments must be made for dif- feed shall contain the name of the ad- fering concentrations of gamma-lino- ditive. lenic acid and for cat food formulas of different caloric density and/or that (2) The label and labeling of the addi- are fed to specific weights, breeds, or tive and any feed premix shall also con- cats of different activity levels to meet tain: the requirements of this paragraph. (i) A statement to indicate that the (d) To assure safe use of the additive, maximum use level of guanidinoacetic in addition to other information re- acid must not exceed 0.12 percent of the quired by the Federal Food, Drug, and complete feed for broiler chickens and Cosmetic Act, the label and labeling of turkeys; and the additive shall bear the following: (ii) Adequate directions for use. (1) The name of the additive, gamma- [81 FR 86269, Nov. 30, 2016] linolenic acid safflower oil, or GLA safflower oil; § 573.500 Condensed, extracted glu- (2) A guarantee for the minimum tamic acid fermentation product. content of gamma-linolenic acid; and Condensed, extracted glutamic acid (3) Adequate directions for use such fermentation product may be safely that the finished animal food complies used in animal feed under the following with the provisions of paragraphs (b) conditions: and (c) of this section. (a) The additive is a concentrated [84 FR 6675, Feb. 28, 2019] mixture of the liquor remaining from the extraction of glutamic acid, com- § 573.496 Guanidinoacetic acid. bined with the cells of Corynebacterium The food additive, guanidinoacetic lilium used to produce the glutamic acid, may be safely used in broiler acid. chicken and turkey feeds in accordance (b) It is used or intended for use as with the following prescribed condi- follows: tions: (1) In poultry feed as a source of pro- (a) The additive is manufactured by tein in an amount not to exceed 5 per- reacting glycine with cyanamide in an cent of the total ration. aqueous solution. (2) In cattle feed as a source of pro- (b) The additive is used or intended tein in an amount not to exceed 10 per- for use to spare arginine and as a pre- cent of the feed. cursor of creatine in broiler chicken (c) In order to assure safe use, the and turkey feeds at levels not to exceed label and labeling of the additive shall 0.12 percent of the complete feed. bear, in addition to the other informa- (c) The additive consists of not less tion required by the Act, the following: than 97 percent guanidinoacetic acid (1) The name of the additive.

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(2) A statement of the concentration § 573.540 Hydrolyzed leather meal. of the additive contained in any mix- (a) Identity. Hydrolyzed leather meal ture. is produced from leather scraps that (3) Adequate directions for use. are treated with steam for not less than 33 minutes at a pressure of not § 573.520 Hemicellulose extract. less than 125 pounds per square inch. Hemicellulose extract may be safely (b) Specifications. The additive shall used in animal feed when incorporated conform to the following percent-by- therein in accordance with the fol- weight specifications: lowing conditions: Moisture, not less than 5 percent nor more (a) The additive is produced from the than 10 percent. aqueous extract obtained by the treat- Crude protein, not less than 60 percent. ment of wood with water at elevated Crude fat, not less than 5 percent. temperatures (325 degrees–535 degrees Crude fiber, not more than 6 percent. F) and pressure (80 to 900 pounds per Chromium, not more than 2.75 percent. square inch) and contains primarily (c) Use. It is used or intended for use pentose and hexose sugars. as a source of protein in swine feeds in (b) The additive may be used in a liq- an amount not to exceed 1.0 percent by uid or dry state with the liquid product weight of the finished feed. containing not less than 55 percent car- (d) Labeling. The labels and labeling bohydrate and the dry product con- shall bear, in addition to the other in- taining not less than 84 percent carbo- formation required by the Act: hydrate. (1) The name of the additive, 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 § 573.550 25-hydroxyvitamin D3. FR 11181, Mar. 17, 1978] The food additive, 25-hydroxyvitamin D3, may be safely used 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 used or intended nickel catalyst. for use as a source of vitamin D3 activ- (b) Specifications. The product con- ity in animal feed or drinking water in accordance with good manufacturing tains 70 percent hydrogenated corn and feeding practices as follows: syrup and a maximum of 0.5 percent re- (1) In feed or drinking water of layer ducing sugars. and breeder chickens not to exceed 69 (c) Uses. The product is used as a hu- parts per billion (ppb) in feed or 34.5 mectant and plasticizer in preparation ppb in drinking water. of soft-moist dog and cat foods. (2) In feed or drinking water of tur- (d) Limitations. The product is pref- keys not to exceed: erably stored in a closed, stainless (i) 92 ppb in feed; or steel or aluminum container. The level (ii) In drinking water, 25 ppb for tur- of use of the product shall not exceed keys up to 3 weeks of age, 36 ppb for 15 percent of the total weight of the pet turkeys from 4 to 11 weeks of age, or 45 food formulation. ppb for turkeys over 11 weeks of age. (e) Labeling. The labeling shall bear, (b) The additive consists of not less in addition to other information re- than 94 percent 25-hydroxyvitamin D3 quired by the Act: (9,10-secocholesta-5,7,10(19)-triene-3b, (1) The name of the additive. 25-diol). (2) Adequate directions for use in ac- (c) The additive meets the following cordance with the provisions in para- specifications: (1) Not more than 1 percent of any in- graph (d) of this section. dividual sterol. [45 FR 22920, Apr. 4, 1980] (2) Not more than 5 percent water.

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(3) Not more than 20 parts per million (2) Adequate directions to provide a (ppm) lead. final product that complies with the (4) Not more than 20 ppm aluminum. limitations prescribed in paragraph (b) (5) Not more than 1.0 percent sol- of this section. vents and non-detectable levels of 2′, 4′, 5′, 7′ tetraiodofluorescin. § 573.580 Iron-choline citrate complex. (6) Not more than 1 ppb 1, 25- Iron-choline citrate complex made by dihydroxycholecalciferol. reacting approximately equimolecular (d) To assure safe use of the additive, quantities of ferric hydroxide, choline, in addition to the other information re- and citric acid may be safely used as a quired by the Federal Food, Drug, and source of iron in animal feed. Cosmetic Act, the label and labeling shall contain: § 573.600 Lignin sulfonates. (1) The name of the additive. Lignin sulfonates may be safely used (2) A statement to indicate the max- in animal feeds in accordance with the imum use level of 25-hydroxyvitamin following prescribed conditions: D3 must not exceed 69 ppb in feed or (a) For the purpose of this section, 34.5 ppb in drinking water for layer and the food additive is either one, or a breeder chickens. combination of, the ammonium, cal- (3) A statement to indicate for tur- cium, magnesium, or sodium salts of keys the maximum use level of 25- the extract of spent sulfite liquor de- hydroxyvitamin D3 must not exceed 92 rived from the sulfite digestion of wood ppb in feed; or in drinking water, 25 ppb or of abaca (Musa textilis) or of sisal for turkeys up to 3 weeks of age, 36 ppb (Agave sisalana) in either a liquid form for turkeys from 4 to 11 weeks of age, (moisture not to exceed 50 percent by or 45 ppb for turkeys over 11 weeks of weight) or dry form (moisture not to age. exceed 6 percent by weight). (4) Adequate use directions to ensure (b) It is used or intended for use in an that 25-hydroxyvitamin D3 (and all pre- amount calculated on a dry weight mixes) is uniformly blended through- basis, as follows: out the feed or drinking water. (1) As a pelleting aid in the liquid or (5) An expiration date on all premix dry form in an amount not to exceed 4 labeling. percent of the finished pellets. (6) A statement on all premix label- (2) As a binding aid in the liquid form ing (feed and drinking water forms) in the flaking of feed grains in an amount not to exceed 4 percent of the that 25-hydroxyvitamin D3 cannot be used simultaneously in both feed and flaked grain. water. (3) As a surfactant in molasses used in feeds, as liquid lignin sulfonate, in [83 FR 49486, Oct. 2, 2018] an amount not to exceed 11 percent of the molasses. § 573.560 Iron ammonium citrate. (4) As a source of metabolizable en- Iron ammonium citrate may be safe- ergy, in the liquid or dry form, in an ly used in animal feed in accordance amount not to exceed 4 percent of the with the following prescribed condi- finished feed. tions: (a) The additive is the chemical § 573.615 Marine microalgae. green ferric ammonium citrate. The food additive, marine (b) The additive is used or intended microalgae, may be safely used as a for use as an anticaking agent in salt source of docosahexaenoic acid (DHA) for animal consumption so that the and other omega-3 fatty acids in ac- level of iron ammonium citrate does cordance with the following prescribed not exceed 25 parts per million (0.0025 conditions: percent) in the finished salt. (a) The additive is dried whole cells (c) To assure safe use of the additive of nonviable, nontoxigenic, nonpatho- the label or labeling of the additive genic Schizochytrium sp. algae grown as shall bear, in addition to the other in- a pure culture. formation required by the Act: (b) The additive is used in complete, (1) The name of the additive. dry adult maintenance food for dogs in

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accordance with good manufacturing (c) To assure safe use, the label and and feeding practices not to exceed 16.5 labeling of the additive shall bear ade- pounds per ton (7.5 kilograms (kg) per quate directions for use. 1000 kg) of complete, dry, adult maintenance dog food. § 573.625 Menadione nicotinamide bi- (c) The additive consists of not less sulfite. than 17.0 percent The food additive may be safely used (4Z,7Z,10Z,13Z,16Z,19Z)-docosa- as follows: 4,7,10,13,16,19-hexaenoic acid (a) The additive is 1,2,3,4-tetrahydro- (docosahexaenoic acid or DHA). 2-methyl-1,4-dioxo-2-naphthalene sul- (d) The additive meets the following fonic acid with 3-pyridine carboxylic specifications: acid amine (CAS No. 73581–79–0). (1) Not less than 40 percent crude fat; (b) The additive is used or intended (2) Not more than 12 percent ash; for use as a nutritional supplement for (3) Not more than 8 percent unsapon- both the prevention of vitamin K defi- ifiable matter; ciency and as a source of supplemental (4) Not more than 5 percent insoluble niacin as follows: impurities; (1) In chicken and turkey feeds at a (5) Not more than 5 percent free fatty level not to exceed 2 grams per ton of acids; and complete feed. (6) Not more than 6 percent water. (2) In growing and finishing swine (e) To ensure the safe use of the addi- feeds at a level not to exceed 10 grams tive, in addition to other information per ton of complete feed. required by the Federal Food, Drug, (c) To assure safe use, the label and and Cosmetic Act: labeling of the additive shall bear ade- (1) The label and labeling of the addi- quate directions for use. tive, any feed premix, and complete [64 FR 46840, Aug. 27, 1999] feed, shall contain the name of the additive, marine microalgae. § 573.637 Methyl esters of conjugated (2) The label and labeling of the addi- linoleic acid (cis-9, trans-11 and tive and any feed premix shall also con- trans-10, cis-12-octadecadienoic tain: acids). (i) A statement to indicate that the The food additive, methyl esters of maximum use level of the additive conjugated linoleic acid (cis-9, trans-11 shall not exceed 16.5 pounds per ton (7.5 and trans-10, cis-12 octadecadienoic kg per 1000 kg) of complete, dry, adult acids), may be safely used in swine feed maintenance dog food. in accordance with the prescribed con- (ii) Adequate directions for use. ditions: [83 FR 19935, May 7, 2018] (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 (1) In chicken and turkey feed at a oleic acid, palmitic acid, stearic acid, level not to exceed 2 grams per ton of linoleic acid, and other associated acid complete feed. esters. (2) In the feed of growing and fin- (b) The additive is used or intended ishing swine at a level not to exceed 10 for use in the feed of growing and fin- grams per ton of feed. ishing swine as a source of fatty acids

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at levels not to exceed 0.6% in the fin- (i) Unsaponifiable matter shall be de- ished feed. termined by the method described in (c) The additive meets the following Section 28.081, ‘‘Unsaponifiable Residue specifications: (20)—Official Final Action’’ of the ‘‘Of- (1) Free methyl alcohol not to exceed ficial Methods of Analysis of the Asso- 0.015%. ciation of Official Analytical Chem- (2) Insoluble impurities not to exceed ists,’’ 13th Ed., 1980, p. 451, which is in- 0.1%. corporated by reference. Copies are (3) Moisture not to exceed 0.5%. available from the AOAC INTER- (4) Unsaponifiable matter not to ex- NATIONAL, 481 North Frederick Ave., ceed 1.0%. suite 500, Gaithersburg, MD 20877, or (d) To assure safe use of the additive, available for inspection at the National in addition to the other information re- Archives and Records Administration quired by the act: (NARA). For information on the avail- (1) The label and labeling of the addi- ability of this material at NARA, call tive and any feed premix shall bear the 202–741–6030, or go to: http:// following: www.archives.gov/federallregister/ (i) The name of the additive. codeloflfederallregulations/ (ii) A statement to indicate that ibrllocations.html. methyl esters of conjugated linoleic (ii) The chick-edema factor bioassay acid (cis-9, trans-11 and trans-10, cis-12 method described under ‘‘26. Oils, Fats, octadecadienoic acids) must not be and Waxes’’ in the Journal of the Asso- added to vitamin or mineral premixes. (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 Final Action’’ in §§ 28.113–28.117, ‘‘Offi- [73 FR 64198, Oct. 29, 2008] cial Methods of Analysis of the Asso- ciation of Official Analytical Chem- § 573.640 Methyl esters of higher fatty ists,’’ 12th Ed., 1975, pp. 509–511, which acids. is incorporated by reference, shall be The food additive methyl esters of employed. (Copies of the methods are higher fatty acids may be safely used available from the AOAC INTER- in animal feeds in accordance with the NATIONAL, 481 North Frederick Ave., following prescribed conditions: suite 500, Gaithersburg, MD 20877, or (a) The food additive is manufactured available for inspectionat the National by reaction of methyl alcohol with Archives and Records Administration feed-grade fats or oils and consists of (NARA). For information on the avail- not less than 70 percent methyl esters ability of this material at NARA, call of the following straight-chain 202–741–6030, or go to: http:// monocarboxylic acids: Docosahexanoic www.archives.gov/federallregister/ acid, eicosapentanoic acid, linoleic codeloflfederallregulations/ acid, myristic acid, oleic acid, palmitic ibrllocations.html. ) The presence of acid, palmitoleic acid, and stearic acid, chick-edema factor shall be determined and lesser amounts of the associated by a comparison between the mean log acid esters. of the pericardial fluid volumes of a (b) The food additive meets the fol- test group and of a concurrent negative lowing specifications: control group. The significance of the (1) Free methyl alcohol not to exceed difference in pericardial fluid volumes 150 parts per million. between the test group and the nega- (2) Unsaponifiable matter not to ex- tive control group is determined by ceed 2 percent. calculating a ‘‘t’’ value according to (3) It is free of chick-edema factor or the formula: other factors toxic to chicks, as evi- denced during the bioassay method for xx− determining the chick-edema factor as t = tc prescribed in paragraph (b)(4)(ii) of this ()sn22//+ () sn section. tt cc (4) For the purposes of this section: where:

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x¯ t and x¯ c are the means of the logs of the § 573.660 Methyl glucoside-coconut oil pericardial fluid volumes of the test and ester. control groups, respectively; Methyl glucoside-coconut oil ester nt and nc are the number of chicks in the re- spective groups; may be safely used in accordance with 2 2 st and sc are the variances of the test and the following conditions: control groups, respectively. (a) The additive meets the specifica- The variances are calculated as follows: tions prescribed in § 172.816 of this chapter. 22 (b) It is used as a surfactant in mo- 2 nx()(∑−∑ x) s = lasses intended for use in animal feed nn( −1) at a level not to exceed 320 parts per where: million. Sx is the sum of the logs of the pericardial § 573.680 Mineral oil. fluid volumes; Sx2 is the sum of the squares of the logs of Mineral oil may be safely used in ani- 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 [41 FR 38652, Sept. 10, 1976, as amended at 47 juxtaposition with the name and equal- FR 41106, Sept. 17, 1982] ly as prominent. (2) The label or labeling of the addi- § 573.685 Natamycin. tive and any feed additive supplement, The food additive natamycin (CAS feed additive concentrate, feed additive No. 7681–93–8) may be safely used in premix, or complete feed prepared broiler chicken feeds in accordance therefrom shall bear adequate direc- with the following specifications: tions for use. (a) The additive is a stereoisomer of [41 FR 38652, Sept. 10, 1976, as amended at 47 22-[(3-amino-3,6,dideoxy-b-D- FR 9397, Mar. 5, 1982; 54 FR 18281, Apr. 28, mannopyranosyl)oxy]-1,3,26- 1989; 70 FR 40880, July 15, 2005; 70 FR 67651, trihydroxy-12-methyl-10-oxo-6,11,28- Nov. 8, 2005] trioxatricyclo[22.3.1.05, 7] octacosa-

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8,14,16,18,20-pentaene-25-carboxylic acid manufacture of complete swine and with the empirical formula C33H47NO13. poultry feeds in accordance with the (b) The additive shall conform to following prescribed conditions: U.S.P. specifications. (a) The additive is manufactured by (c) The additive (as part of a premix the reaction of 99 percent formic acid composed of calcium carbonate, and 50 percent sodium hydroxide in natamycin, and lactose) is used for re- water to produce a solution made up of tarding the growth of Aspergillus at least 20.5 percent sodium salt of for- parasiticus in broiler chicken feeds for mic acid and not more than 61 percent up to 14 days after the addition of formic acid. natamycin. (b) The additive is used or intended (d) Each pound (454 grams (g)) of the for use as a feed acidifying agent, to premix shall contain 434 (g) of calcium carbonate, 10 g of natamycin activity, lower the pH, in complete swine and and 10 g of lactose. The premix shall be poultry feeds at levels not to exceed 1.2 mixed into broiler chicken feed at the percent of the complete feed. rate of 1 pound (0.454 kilograms (kg)) (c) To assure safe use of the additive, per ton (908 kg) of feed to provide formic acid and formate salts from all natamycin at a level of 11 parts per added sources cannot exceed 1.2 percent million (ppm). The premix shall be of complete feed when multiple sources thoroughly mixed into the dry compo- of formic acid and its salts are used in nents of the broiler chicken feed before combination. adding the liquid components. Broiler (d) To assure safe use of the additive, feeds to which the natamycin premix is in addition to the other information re- added shall be used within 4 weeks of quired by the Federal Food, Drug, and addition of the premix. Cosmetic Act, the label and labeling (e) To assure the safe use of the addi- shall contain: tive, the label or labeling of the addi- (1) The name of the additive. tive shall bear, in addition to other in- (2) Adequate directions for use, information required by the Federal cluding a statement that feed grade so- Food, Drug, and Cosmetic Act, the fol- dium formate must be uniformly ap- lowing: plied and thoroughly mixed into com- (1) The name and CAS number of the plete feeds and that the complete feeds additive, and its purpose. so treated shall be labeled as con- (2) A listing of ingredients consisting taining feed grade sodium formate. of calcium carbonate, the additive, and lactose and their proportions in the (3) Cautions for use including this premix as prescribed under paragraph statement: Caution: Follow label direc- (d) of this section. tions. Formic acid and formate salts (3) Adequate directions for use to en- from all added sources cannot exceed sure a broiler chicken feed that is in 1.2 percent of complete feed when mul- compliance with the limitations pre- tiple sources of formic acid and its scribed in paragraph (d) of this section. salts are used in combination. (4) An appropriate cautionary state- (e) To assure safe use of the additive, ment: ‘‘Caution: Store in a tightly- in addition to the other information re- closed, light-resistant container in a quired by the act and paragraph (d) of cool, dry place.’’ this section, the label and labeling (5) An expiration date of 1 year from shall contain: the date of manufacture. (1) Appropriate warnings and safety (6) A contact address and telephone precautions concerning feed grade so- number for reporting adverse reactions dium formate. experienced by users, or to request a (2) Statements identifying feed grade copy of the Material Safety Data Sheet sodium formate as a corrosive and pos- for natamycin. sible severe irritant. [69 FR 19321, Apr. 13, 2004] (3) Information about emergency aid in case of accidental exposure as fol- § 573.696 Feed grade sodium formate. lows: The food additive, feed grade sodium (i) Statements reflecting require- formate, may be safely used in the ments of applicable sections of the

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Superfund Amendments and Reauthor- (c) It is used in animal feed for the ization Act (SARA), and the Occupa- following purposes: tional Safety and Health Administra- (1) To reduce dustiness of feeds or tion (OSHA) human safety guidance mineral supplements. regulations. (2) To serve as a lubricant in the (ii) Contact address and telephone preparation of pellets, cubes, or blocks, number for reporting adverse reactions and to improve resistance to moisture or to request a copy of the Material of such pellets, cubes, or blocks. Safety Data Sheet (MSDS). (d) The quantity of petrolatum [81 FR 67154, Sept. 30, 2016, as amended at 81 present in animal feeds from the uses FR 95027, Dec. 27, 2016] specified in paragraph (c) of this section shall not exceed 3 percent in min- § 573.700 Sodium nitrite. eral supplements nor shall it exceed Sodium nitrite may be safely used in 0.06 percent of the total ration when canned pet food containing meat and present in feed or feed concentrates. fish in accordance with the following (e) When used in combination with prescribed conditions: technical white mineral oil for the uses (a) It is used or intended for use described in paragraph (c) of this sec- alone as a preservative and color fixa- tion, the total quantity of combined tive in canned pet food containing fish, petrolatum and technical white min- meat, and fish and meat byproducts so eral oil shall not exceed the limits pre- that the level of sodium nitrite does scribed in paragraph (d) of this section. not exceed 20 parts per million. (f) Petrolatum may contain any anti- (b) To assure safe use of the additive, oxidant permitted in food by regula- in addition to the other information re- tions issued in accordance with section quired by the act: 409 of the act, in an amount not greater (1) The label of the additive shall than that required to produce its in- bear: tended effect. (i) The name of the additive. (ii) A statement of the concentration § 573.740 Odorless light petroleum hy- of the additive in any mixture. drocarbons. (2) The label or labeling shall bear Odorless light petroleum hydro- adequate directions to provide a final carbons complying with § 172.884(a) and product that complies with the limita- (b) of this chapter may be safely used tions prescribed in paragraph (a) of this in an amount not in excess of that re- section. quired as a component of insecticide § 573.720 Petrolatum. formulations used in compliance with regulations issued in this part. Petrolatum may be safely used in or on animal feed, subject to the fol- § 573.750 Pichia pastoris dried yeast. lowing prescribed conditions: (a) Petrolatum complies with the (a) Identity. The food additive Pichia specifications set forth in the U.S. pastoris dried yeast may be used in feed Pharmacopeia XVI for white petro- formulations of broiler chickens as a latum or in The National Formulary source of protein not to exceed 10 per- XII for yellow petrolatum. cent by weight of the total formula- (b) Petrolatum meets the following tion. ultraviolet absorbance limits when (b) Specifications. The additive shall subjected to the analytical procedure conform to the following percent-by- described in § 172.886(b) of this chapter. weight specifications: (1) Crude protein, not less than 60 Ultraviolet absorbance per centimeter percent. path length: (2) Crude fat, not less than 2 percent. Millimicrons Maximum (3) Crude fiber, not more than 2 per- 280 to 289 ...... 0.25 cent. 290 to 299 ...... 20 (4) Ash, not more than 13 percent. 300 to 359 ...... 14 (5) Moisture, not more than 6 per- 360 to 400 ...... 04 cent.

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(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, the name of the additive, directions for (d) Labeling. The labels and labeling use to provide not more than 10 percent shall bear in addition to the other in- by weight of the total ration, and the formation required by the Act: statement ‘‘Caution: Not to be used in (1) The name of the additive ‘‘poly- layers or other poultry intended for ethylene roughage replacement.’’ breeding.’’ (2) Adequate directions for use which shall provide for the administration of [58 FR 59170, Nov. 8, 1993] one-half pound of polyethylene pellets § 573.760 Poloxalene. per head per day for 6 successive days. The food additive poloxalene may be All natural roughage should be re- safely used in accordance with the fol- moved for a minimum of 12 hours prior lowing prescribed conditions: to administration of polyethylene (a) The additive consists of polyoxy- roughage replacement. Roughage re- propylene-polyoxyethylene glycol non- placement must be adequately mixed ionic block polymer meeting the fol- in the ration for uniform distribution. lowing specifications: [41 FR 38652, Sept. 10, 1976, as amended at 54 (1) Molecular weight range: 2,850– FR 18282, Apr. 28, 1989] 3,150. (2) Hydroxyl number: 35.7–39.4. § 573.800 Polyethylene glycol (400) (3) Cloud point (10 percent solution): mono- and dioleate. 42 °C–46 °C. (a) The food additive polyethylene (4) Structural formula: glycol (400) mono- and dioleate meets ⎯⎯ the following specifications: Saponi- HO(CH2211 CH O)( -13) ⎯⎯ ⎯⎯ fication number, 80–88; acid number, 5.0 CHCH2 O(32-36) ( CH2211 CH O)( -13) H maximum; and average molecular weight range, 640–680. CH3 (b) It is used as a processing aid in (b) In feed as a surfactant for the the production of animal feeds when flaking of feed grains when added to present as a result of its addition to liquid grain conditioner in an amount molasses in an amount not to exceed not to exceed 1.0 percent of the conditioner. The conditioner is added to the 250 parts per million of the molasses. feed at a rate of 1 quart per ton of feed. § 573.820 Polyoxyethylene glycol (400) (c) The label and labeling shall bear, mono- and dioleates. in addition to the other information required by the Act: The food additive polyoxyethylene (1) The name of the additive. glycol (400) mono- and dioleates may be (2) Adequate directions and warnings safely used as an emulsifier in calf- for use. milk replacer formulations.

§ 573.780 Polyethylene. § 573.840 Polysorbate 60. (a) Identity. Polyethylene consists of The food additive polysorbate 60 basic polymers manufactured by the (polyoxyethylene (20) sorbitan mono- catalytic polymerization of ethylene. stearate) may be safely used in animal (b) Specifications. (1) For the purposes feeds in accordance with the following of this section, polyethylene shall meet prescribed conditions: the specifications in item 2.1 of (a) It is used alone or in combination § 177.1520(c) of this chapter. with sorbitan monostearate as an (2) The polyethylene is designed in a emulsifier in mineral premixes and die- pellet form in a configuration pre- tary supplements for animal feeds. senting maximum angular surface having the following dimensions in centi- (b) It is used as an emulsifier in milk- meters: replacer formulations for calves.

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§ 573.860 Polysorbate 80. at least 90 percent is subsequently dispersible under abomasal conditions. The food additive polysorbate 80 (polyoxyethylene (20) sorbitan (c) Label and labeling. To ensure safe monooleate) may be safely used as an use of the additive, the label and label- emulsifier in milk-replacer formula- ing of the additive and of any feed addi- tions for calves. tive supplement, feed additive concentrate, feed additive premix, or liq- § 573.870 Poly(2-vinylpyridine-co-sty- uid feed supplement prepared there- rene). from, shall bear, in addition to the 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 for beef cattle and dairy cattle and re- (1) The name of the additive. placement dairy heifers when used in (2) A statement of the concentration accordance with the following condi- of poly(2-vinylpyridine-co-styrene) in tions: any product or mixture. (a) The additive meets the following (3) Adequate directions for the use of specifications: the rumen-stable, abomasum-dispersible nutrient(s) products. Component/property Limitation (4) The following statement: ‘‘Warn- ing: Maximum use of poly(2- Inherent viscosity ...... 1.0-1.6 deciliter per gram.1 Styrene moiety ...... 40 percent maximum. vinylpyridine-co-styrene) from all 2-Vinylpyridine moiety...... 90 percent maximum. sources is not to exceed 5.1 grams per Residual styrene ...... 200 parts per billion max- head per day.’’ imum. Residual 2-vinylstyrene ...... 200 parts per billion max- [57 FR 7875, Mar. 5, 1992, as amended at 57 FR imum. 24187, June 8, 1992; 61 FR 11547, Mar. 21, 1996; Heavy metals such as lead .... 10 parts per million max- 70 FR 13100, Mar. 18, 2005] imum. Arsenic ...... 3 parts per million maximum. § 573.880 Normal propyl alcohol. 1 Inherent viscosity of a 0.25 percent (weight/volume) solution in dimethylformamide. Normal propyl alcohol may be safely (b) The additive is used in the manu- used in feeds and feed supplements for facture of rumen-stable, abomasum- cattle as a source of metabolizable en- dispersible nutrient(s) for beef cattle ergy. It is incorporated in the feed or and dairy cattle and replacement dairy feed supplement in an amount which heifers such that the maximum use of provides not more than 54.5 grams of the additive from all sources does not the additive per head per day. exceed 5.1 grams per head per day. The § 573.900 Pyrophyllite. additive may be used to protect the following nutrients: Pyrophyllite (aluminum silicate (1) Methionine. The resulting product monohydrate) may be safely used as must contain a maximum of 10 percent the sole anticaking aid, blending agent, poly(2-vinylpyridine-co-styrene) by pelleting aid, or carrier in animal feed weight and a minimum of 55 percent when incorporated therein in an methionine by weight. The coated me- amount not to exceed 2 percent in com- thionine must be established through plete animal feed. in vitro tests to be at least 90 percent rumen-stable, of which at least 90 per- § 573.914 Salts of volatile fatty acids. cent is subsequently dispersible under (a) Identity. The food additive is a abomasal conditions. blend containing the ammonium or (2) Methionine and lysine. The result- calcium salt of isobutyric acid and the ing product must contain a maximum ammonium or calcium salts of a mix- of 10 percent poly(2-vinylpyridine-co- ture of 5-carbon acids—isovaleric, 2- styrene) by weight and a minimum of a methylbutyric, and n-valeric. combined total of 55 percent methio- (b) Specifications. The additive con- nine and lysine by weight. The coated tains ammonium or calcium salts of methionine and lysine must be estab- volatile fatty acids and shall conform lished through in vitro tests to be at to the following specifications: least 90 percent rumen-stable, of which (1) Ammonium salts:

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Components Amount missioner of Food and Drugs makes a determination that: Ammonium salts of mixed 5-car- 48 to 54 percent. bon acids (as identified in para- (1) Selenium additives are not essen- graph (a) of this section). tial at levels authorized in the absence 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 maximum. to the animals consuming the additive; 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; (4) selenium at such levels does not Components Amount achieve its intended effect of pro- Calcium salts of mixed 5-carbon 58 to 72 percent. moting normal growth and reproduc- acids (as identified in paragraph tion of livestock and poultry; and (a) of this section). (5) the manufacture and use of sele- Calcium salt of isobutyric acid ...... 26 to 34 percent. Calcium hydroxide ...... 3 percent maximum. nium at such levels cannot reasonably Water ...... 14 percent maximum. be controlled by adherence to current Arsenic ...... 3 parts per million max- good manufacturing practice require- imum. ments. Heavy metals such as lead ...... 10 parts per million maximum. (6) Paragraphs (b) through (g) of this section provide the currently accept- (c) Use. The additive is used or in- able levels of selenium supplemen- tended for use as a source of energy in tation. dairy cattle feed. (b) The food additive selenium is a (d) Labeling. The label and labeling of nutrient administered in animal feed the additive in any feed, feed supple- as sodium selenite or sodium selenate ment, feed concentrate, feed premix, or as provided in paragraph (c) of this sec- liquid feed supplement prepared there- tion, as a controlled-release sodium from shall bear, in addition to other in- selenite bolus as provided in paragraph formation required by the act, the fol- (f) of this section, as selenium yeast as lowing: provided in paragraph (g) of this sec- (1) The name of the additive. tion, or as selenomethionine hydroxy (2) Adequate directions for use, in- analogue as provided in paragraph (h) cluding statements expressing max- of this section. imum use levels. For ammonium salts (c) Selenium, as sodium selenite or of volatile fatty acids, the statements: sodium selenate, is added to feed as fol- ‘‘Not to exceed 160 grams per head per lows: day thoroughly mixed in dairy cattle (1) In complete feed for chickens, feed as a source of energy.’’ For cal- swine, turkeys, sheep, cattle, and cium salts of volatile fatty acids, the ducks at a level not to exceed 0.3 part statement: ‘‘Not to exceed 135 grams per million. per head per day thoroughly mixed in (2) In feed supplements for limit feed- dairy cattle feed as a source of ening as follows: ergy.’’ (i) Sheep: At a level not to exceed an intake of 0.7 milligram per head per [49 FR 45125, Nov. 15, 1984; 50 FR 8606, Mar. 4, day. 1985, as amended at 70 FR 13100, Mar. 18, 2005] (ii) Beef cattle: At a level not to exceed an intake of 3 milligrams per head § 573.920 Selenium. per day. (a) Public Law 103–354 enacted Octo- (3) In salt-mineral mixtures for free- ber 13, 1994 (the 1994 Act), states that choice feeding as follows: FDA shall not implement or enforce (i) Sheep: Up to 90 parts per million in the final rule issued on September 13, a mixture for free-choice feeding at a 1993 (58 FR 47962), in which FDA stayed rate not to exceed an intake of 0.7 mil- the 1987 amendments and any modifica- ligram per head per day. tion of such rule issued after enact- (ii) Beef cattle: Up to 120 parts per ment of the 1994 Act; unless the Com- million in a mixture for free-choice

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feeding at a rate not to exceed an in- containing excess selenium. Do not take of 3 milligrams per head per day. rebolus within 4 months.’’ (4) The additive, as sodium selenite (g) Selenium yeast is a dried, non- or sodium selenate, shall be incor- viable yeast (Saccharomyces cerevisiae) porated into feed as follows: cultivated in a fed-batch fermentation (i) It shall be incorporated into each which provides incremental amounts of ton of complete feed by adding no less cane molasses and selenium salts in a than 1 pound of a premix containing no manner which minimizes the detri- more than 272.4 milligrams of added se- mental effects of selenium salts on the lenium per pound. growth rate of the yeast and allows for (ii) It shall be incorporated into each optimal incorporation of inorganic se- ton of salt-mineral mixture for sheep lenium into cellular organic material. or beef cattle from a premix containing Residual inorganic selenium is elimi- no more than 4.5 grams of added sele- nated in a rigorous washing process nium per pound. and must not exceed 2 percent of the (5) Usage of the additive must con- total selenium content in the final se- form to the requirements of paragraphs lenium yeast product. (d) and (e) of this section. (1) Selenium, as selenium yeast, is (d) The premix manufacturer shall added to feed as follows: follow good manufacturing practices in (i) In complete feed for chickens, tur- the production of selenium premixes. keys, swine, beef cattle, and dairy cat- Inventory, production, and distribution tle at a level not to exceed 0.3 part per records must provide a complete and million. accurate history of product production. (ii) In feed supplements for limit Production controls must assure prod- feeding for beef cattle at a level not to ucts to be what they are purported and exceed an intake of 3 milligrams per labeled. Production controls shall in- head per day. clude analysis sufficient to adequately (iii) In salt-mineral mixtures for free- monitor quality. choice feeding for beef cattle up to 120 (e) The label or labeling of any sele- parts per million in a mixture for free- nium premix shall bear adequate direc- choice feeding at a rate not to exceed tions and cautions for use including an intake of 3 milligrams per head per this statement: ‘‘Caution: Follow label day. directions. The addition to feed of (2) Guaranteed organic selenium con- higher levels of this premix containing tent from selenium yeast must be de- selenium is not permitted.’’ clared on the selenium yeast product (f) The additive is orally adminis- label. tered to beef and dairy cattle as an os- (3) The additive, as selenium yeast, motically controlled, constant release shall be incorporated into feed as fol- bolus containing sodium selenite. Each lows: bolus contains 360 milligrams of sele- (i) It shall be incorporated into each nium as sodium selenite, and delivers 3 ton of complete feed by adding no less milligrams of selenium per day for 120 than 1 pound of a premix containing no days. To ensure safe use of the addi- more than 272.4 milligrams of added se- tive: lenium per pound. (1) The osmotically controlled, con- (ii) It shall be incorporated into each stant release bolus is for use only in ton of salt-mineral mixture for beef beef and dairy cattle more than 3 cattle from a premix containing no months of age or over 200 pounds body more than 4.5 grams of added selenium weight. per pound. (2) Only one bolus containing 360 mil- (4) Usage of this additive must con- ligrams of selenium as sodium selenite form to the requirements of paragraphs is administered orally to each animal (d) and (e) of this section. in 120 days. (h) Selenomethionine hydroxy ana- (3) The labeling shall bear the fol- logue [R,S–2-hydroxy-4- lowing: ‘‘This bolus delivers the max- methylselenobutanoic acid (CAS imum daily allowable amount of sele- 873660–49–2)] is manufactured by the re- nium and shall be the sole source of action of elemental selenium with supplementation. Do not use in areas methyllithium to form a methylseleno

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salt, which is then reacted with R,S–2- (5) Usage of this additive must con- hydroxybutyrolactone to form a salt of form to the requirements of paragraphs 2-hydroxy-4-methylselenobutanoic (d) and (e) of this section. acid. After acidification and purifi- [52 FR 10888, Apr. 6, 1987; 52 FR 21001, June 4, cation, the additive consists of not less 1987, as amended at 54 FR 14215, Apr. 10, 1989; than 39.5 percent total selenium by 54 FR 15874, Apr. 19, 1989; 60 FR 53703, Oct. 17, weight with a selenomethionine hy- 1995; 65 FR 35824, June 6, 2000; 65 FR 53167, droxy analogue content of not less Sept. 1, 2000; 67 FR 46851, July 17, 2002; 68 FR than 98 percent of total selenium. The 52340, Sept. 3, 2003; 72 FR 39561, July 19, 2007; total organic selenium content of the 84 FR 7993, Mar. 6, 2019] additive is not less than 99 percent of EFFECTIVE DATE NOTE: At 58 FR 47973, total selenium. Sept. 13, 1993, the amendments to § 573.920 (1) The selenomethionine hydroxy that were published at 52 FR 10887, Apr. 6, analogue meets the following specifica- 1987; 52 FR 21001, June 4, 1987; and 54 FR 14214, Apr. 10, 1989 were stayed until further tions: notice. At 59 FR 45973, Sept. 6, 1994, the stay (i) Arsenic, not more than 2 parts per was confirmed. million (ppm); (ii) Cadmium, not more than 1 ppm; § 573.940 Silicon dioxide. (iii) Lead, not more than 1 ppm; and The food additive silicon dioxide may (iv) Mercury, not more than 1 ppm. be safely used in animal feed in accord- (2) Selenium, as selenomethionine ance with the following conditions: hydroxy analogue, is added to complete (a) The food additive is manufactured feed for chickens, turkeys, and swine by vapor phase hydrolysis or by other at a level not to exceed 0.3 ppm. means whereby the particle size is such (3) To ensure safe use of the additive, as to accomplish the intended effect. in addition to the other information re- (b) It is used or intended for use in quired by the Federal Food, Drug, and feed components as an anticaking Cosmetic Act, the label and labeling of agent, and/or grinding aid, as follows: selenomethionine hydroxy analogue in Limitations its packaged form shall contain: Feed component (percent) (i) The name, selenomethionine hydroxy analogue; BHT (butylated hydroxytoluene) ...... 2 (ii) Minimum and maximum guaran- Methionine hydroxy analog and its calcium salts 1 Piperazine, piperazine salts ...... 0.8 tees for a total selenium content of not Sodium propionate ...... 1 less than 2.08 percent (weight/weight) Urea ...... 1 and not more than 2.24 percent; Vitamins ...... 3 (iii) Minimum guarantee for selenomethionine hydroxy analogue (c) It is used in feed as an anticaking content of not less than 5.2 percent; agent in an amount not to exceed that (iv) The following statement, ‘‘Stor- reasonably required to accomplish its age Conditions: Selenomethionine hy- intended effect and in no case in an droxy analogue must be stored in a amount to exceed 2 percent by weight closed package at temperatures not of the finished feed. higher than 20 °C (68 °F).’’; and (d) It is used or intended for use in (v) An expiration date not to exceed feed components, as a carrier as follows: 1 year from the date of manufacture. (4) The additive, as selenomethionine Feed component Limitations hydroxy analogue, shall be incor- (percent) porated into each ton of complete feed Flavors ...... 50 by adding no less than 1 pound of a pre- Selenomethionine hydroxy analogue ...... 95 mix containing no more than 272.4 milligrams of added selenium per pound. (e) To ensure safe use of the additive, silicon dioxide is to be used in an amount not to exceed that reasonably required to accomplish its intended effect, and silicon dioxide from all

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sources cannot exceed 2 percent by (2)(i) Verxite flakes: The additive weight of the complete feed. contains a minimum of 98 percent of hydrobiotite; it has a bulk density of [41 FR 38652, Sept. 10, 1976, as amended at 83 FR 8930, Mar. 2, 2018; 84 FR 7993, Mar. 6, 2019] from 20 to 30 pounds per cubic foot. (ii) It is used or intended for use as § 573.960 Sorbitan monostearate. an anticaking or blending agent in ru- The food additive sorbitan monostea- minant feeds in an amount not to ex- rate may be safely used alone or in ceed that necessary to accomplish its combination with polysorbate 60 as an intended effect and in no case to exceed emulsifier in mineral premixes and die- 1 percent by weight of the final feed for tary supplements for animal feeds. ruminants. (3)(i) Verxite grits: The additive con- § 573.980 Taurine. tains a minimum of 80 percent of The food additive taurine (2-amino- hydrobiotite; it has a bulk density of ethanesulfonic acid) may be safely used from 40 to 50 pounds per cubic foot. in feed in accordance with the fol- (ii) It is used or intended for use as a lowing prescribed conditions: partial roughage replacement in rumi- (a) It is used as a nutritional supple- nant feeds in an amount not to exceed ment in the feed of growing chickens. that necessary to accomplish its in- (b) It is added to complete feeds so tended effect and in no case to exceed that the total taurine content does not 1 percent by weight of the final feed. exceed 0.054 percent of the feed. (b) To assure safe use of the additive, (c) To assure safe use of the additive, the label of any feed additive supple- the label and labeling shall bear in ad- ment, feed additive concentrate, feed dition to the other information re- additive premix, or complete feed pre- quired by the Act: pared therefrom shall bear, in addition (1) The name of the additive. to the other information required by (2) The quantity of the additive con- the Act, the name of the additive tained therein. (verxite granules, verxite flakes, or (3) Adequate directions for use. verxite grits), adequate directions for use, and, when the additive is present § 573.1000 Verxite. in excess of 1 percent, a statement of The food additive verxite may be the quantity of the additive contained safely used in animal feed in accord- therein and the term ‘‘nonnutritive’’ in ance with the following prescribed con- juxtaposition therewith. ditions: (a) The additive is a magnesium-alu- § 573.1010 Xanthan gum. minum-iron silicate conforming to one The food additive xanthan gum may of the following: be safely used in animal feed as fol- (1)(i) Verxite granules: The additive lows: contains a minimum of 98 percent of hydrobiotite; it is thermally expanded (a) The food additive is xanthan gum and has a bulk density of from 5 to 9 as defined in § 172.695 of this chapter pounds per cubic foot. and meets all of the specifications (ii) It is used or intended for use: thereof. (a) In poultry feed at a level not to (b) It is used or intended for use as a exceed 5 percent of the weight of the stabilizer, emulsifier, thickener, sus- finished feed as a nonnutritive bulking pending agent, or bodying agent in ani- agent for restricting calorie intake in mal feed as follows: pullet replacement feeds. (1) In calf milk replacers at a max- (b) As an anticaking or blending imum use level of 0.1 percent, as fed. agent, pelleting aid, or nonnutritive (2) In liquid feed supplements for ru- carrier for the incorporation of nutri- minant animals at a maximum use ents in poultry, swine, dog, or rumi- level of 0.25 percent (5 pounds per ton). nant feeds, in an amount not to exceed (c) To assure safe use of the additive: that necessary to accomplish its in- (1) The label of its container shall tended effect and in no case to exceed bear, in addition to other information 1.5 percent of the dog feed or 5 percent required by the act, the name of the of the final feed for other animals. additive.

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(2) The label or labeling of the addi- Subpart B—Radiation and tive container shall bear adequate di- Radiation Sources rections for use. [49 FR 44630, Nov. 8, 1984] § 579.22 Ionizing radiation for treatment of animal diets. § 573.1020 Yellow prussiate of soda. Ionizing radiation for treatment of Yellow prussiate of soda (sodium fer- complete diets for animals may be rocyanide decahydrate: Na4Fe(Cn)6°- safely used under the following condi- 10H2O) may be safely used as an tions: anticaking agent in salt for animal (a) Energy sources. Ionizing radiation consumption at a level not to exceed 13 is limited to: parts per million. The additive con- (1) Gamma rays for sealed units of tains a minimum of 99.0 percent by the radionuclides cobalt-60 or cesium- weight of sodium ferrocyanide decahy- 137. drate. (2) Electrons generated from machine sources at energy levels not to exceed [41 FR 38657, Sept. 10, 1976; 41 FR 48100, Nov. 2, 1976] 10 million electron volts. (b) Uses. (1) The ionizing radiation is used or intended for use in single treat- PART 579—IRRADIATION IN THE ment as follows: PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL Food for irradiation Limitations Use

FEED AND PET FOOD Bagged complete Absorbed dose: Microbial disinfec- diets, packaged Not to exceed tion, control or Subpart A—General Provisions feeds, feed ingre- 50 kiloGrays. elimination dients, bulk feeds, Feeds and Sec. animal treats and feed ingredi- 579.12 Incorporation of regulations in part chews. ents treated by irradiation 179. should be formulated to Subpart B—Radiation and Radiation account for Sources nutritional loss. 579.22 Ionizing radiation for treatment of animal diets. (2) If an irradiated feed ingredient is 579.40 Ionizing radiation for the treatment less than 5 percent of the final product, of poultry feed and poultry feed ingredi- the final product can be irradiated ents. without being considered to be re-irra- AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 371. diated. [51 FR 5993, Feb. 19, 1986; 51 FR 8315, Mar. 11, Subpart A—General Provisions 1986, as amended at 58 FR 18148, Apr. 8, 1993; 66 FR 18540, Apr. 10, 2001] § 579.12 Incorporation of regulations in part 179. § 579.40 Ionizing radiation for the Regulations providing for irradiation treatment of poultry feed and poul- in the production, processing, and han- try feed ingredients. dling of food in part 179 of this chapter Ionizing radiation for the treatment are incorporated in subchapter E as ap- of complete poultry diets and poultry plicable to use in the production, proc- feed ingredients may be safely used as essing, handling, and labeling of ani- follows: mal feed and pet food, except where (a) Energy sources. Ionizing radiation specifically provided for in this part. is limited to: Any facility that treats animal feed (1) Gamma rays from sealed units of and pet food with ionizing radiation cobalt-60 or cesium-137; must comply with the requirements of (2) Electrons generated from machine part 507 of this chapter and other appli- sources at energy levels not to exceed cable regulations. 10 million electron volts (MeV); [51 FR 5993, Feb. 19, 1986, as amended at 80 (3) X-rays generated from machine FR 56356, Sept. 17, 2015] sources at energies not to exceed 5

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MeV, except as permitted by Subpart B—General Purpose Food § 179.26(a)(4) of this chapter; or Additives (4) X-rays generated from machine 582.1005 Acetic acid. sources using tantalum or gold as the 582.1009 Adipic acid. target material and using energies not 582.1033 Citric acid. to exceed 7.5 MeV. 582.1057 Hydrochloric acid. (b) Limitation. The ionizing radiation 582.1061 Lactic acid. is used for feed or feed ingredients that 582.1069 Malic acid. do not contain drugs. 582.1073 Phosphoric acid. 582.1077 Potassium acid tartrate. (c) Use. Ionizing radiation is used as 582.1087 Sodium acid pyrophosphate. a single treatment for rendering com- 582.1091 Succinic acid. plete poultry diets or poultry feed in- 582.1095 Sulfuric acid. gredients salmonella negative as fol- 582.1099 Tartaric acid. lows: 582.1125 Aluminum sulfate. (1) Minimum dose 2.0 kiloGrays (kGy) 582.1127 Aluminum ammonium sulfate. (0.2 megarad (Mrad)); maximum dose 25 582.1129 Aluminum potassium sulfate. 582.1131 Aluminum sodium sulfate. kGy (2.5 megarads Mrad). The absorbed 582.1135 Ammonium bicarbonate. dose of irradiation is to be based on ini- 582.1137 Ammonium carbonate. tial concentration of salmonella using 582.1139 Ammonium hydroxide. the relationship that 1.0 kGy (0.1 Mrad) 582.1141 Ammonium phosphate. reduces salmonella concentration by 582.1143 Ammonium sulfate. one log cycle (one decimal reduction). 582.1155 Bentonite. 582.1165 Butane. (2) Feeds treated by irradiation 582.1191 Calcium carbonate. should be formulated to account for 582.1193 Calcium chloride. nutritional loss. 582.1195 Calcium citrate. (3) If an irradiated feed ingredient is 582.1199 Calcium gluconate. less than 5 percent of the final product, 582.1205 Calcium hydroxide. the final product can be irradiated 582.1207 Calcium lactate. without being considered to be re- 582.1210 Calcium oxide. 582.1217 Calcium phosphate. irradiated. 582.1235 Caramel. [60 FR 50099, Sept. 28, 1995, as amended at 78 582.1240 Carbon dioxide. FR 27304, May 10, 2013; 78 FR 34565, June 10, 582.1275 Dextrans. 2013] 582.1320 Glycerin. 582.1324 Glyceryl monostearate. 582.1355 Helium. PART 582—SUBSTANCES 582.1366 Hydrogen peroxide. GENERALLY RECOGNIZED AS SAFE 582.1400 Lecithin. 582.1425 Magnesium carbonate. 582.1428 Magnesium hydroxide. Subpart A—General Provisions 582.1431 Magnesium oxide. Sec. 582.1480 Methylcellulose. 582.1 Substances that are generally recog- 582.1500 Monoammonium glutamate. nized as safe. 582.1516 Monopotassium glutamate. 582.1540 Nitrogen. 582.10 Spices and other natural seasonings 582.1585 Papain. and flavorings. 582.1613 Potassium bicarbonate. 582.20 Essential oils, oleoresins (solvent- 582.1619 Potassium carbonate. free), and natural extractives (including 582.1625 Potassium citrate. distillates). 582.1631 Potassium hydroxide. 582.30 Natural substances used in conjunc- 582.1643 Potassium sulfate. tion with spices and other natural 582.1655 Propane. seasonings and flavorings. 582.1666 Propylene glycol. 582.40 Natural extractives (solvent-free) 582.1685 Rennet. used in conjunction with spices, 582.1711 Silica aerogel. seasonings, and flavorings. 582.1721 Sodium acetate. 582.50 Certain other spices, seasonings, es- 582.1736 Sodium bicarbonate. sential oils, oleoresins, and natural ex- 582.1742 Sodium carbonate. tracts. 582.1745 Sodium carboxymethylcellulose. 582.60 Synthetic flavoring substances and 582.1748 Sodium caseinate. adjuvants. 582.1751 Sodium citrate. 582.80 Trace minerals added to animal feeds. 582.1763 Sodium hydroxide. 582.99 Adjuvants for pesticide chemicals. 582.1775 Sodium pectinate.

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582.1778 Sodium phosphate. Subpart F—Nutrients and/or Dietary 582.1781 Sodium aluminum phosphate. Supplements 582.1792 Sodium sesquicarbonate. 582.1804 Sodium potassium tartrate. 582.5013 Ascorbic acid. 582.1810 Sodium tripolyphosphate. 582.5017 Aspartic acid. 582.1901 Triacetin. 582.5049 Aminoacetic acid. 582.1973 Beeswax. 582.5065 Linoleic acid. 582.5118 Alanine. 582.1975 Bleached beeswax. 582.5145 Arginine. 582.1978 Carnauba wax. 582.5159 Biotin. 582.5191 Calcium carbonate. Subpart C—Anticaking Agents 582.5195 Calcium citrate. 582.5201 Calcium glycerophosphate. 582.2122 Aluminum calcium silicate. 582.5210 Calcium oxide. 582.2227 Calcium silicate. 582.5212 Calcium pantothenate. 582.2437 Magnesium silicate. 582.5217 Calcium phosphate. 582.2727 Sodium aluminosilicate. 582.5223 Calcium pyrophosphate. 582.2729 Hydrated sodium calcium 582.5230 Calcium sulfate. aluminosilicate. 582.5245 Carotene. 582.2906 Tricalcium silicate. 582.5250 Choline bitartrate. 582.5252 Choline chloride. Subpart D—Chemical Preservatives 582.5260 Copper gluconate. 582.5271 Cysteine. 582.3013 Ascorbic acid. 582.5273 Cystine. 582.3021 Benzoic acid. 582.5301 Ferric phosphate. 582.3041 Erythorbic acid. 582.5304 Ferric pyrophosphate. 582.3081 Propionic acid. 582.5306 Ferric sodium pyrophosphate. 582.3089 Sorbic acid. 582.5308 Ferrous gluconate. 582.3109 Thiodipropionic acid. 582.5311 Ferrous lactate. 582.3149 Ascorbyl palmitate. 582.5315 Ferrous sulfate. 582.3169 Butylated hydroxyanisole. 582.5361 Histidine. 582.3173 Butylated hydroxytoluene. 582.5370 Inositol. 582.5375 Iron reduced. 582.3189 Calcium ascorbate. 582.5381 Isoleucine. 582.3221 Calcium propionate. 582.5406 Leucine. 582.3225 Calcium sorbate. 582.5411 Lysine. 582.3280 Dilauryl thiodipropionate. 582.5431 Magnesium oxide. 582.3336 Gum guaiac. 582.5434 Magnesium phosphate. 582.3490 Methylparaben. 582.5443 Magnesium sulfate. 582.3616 Potassium bisulfite. 582.5446 Manganese chloride. 582.3637 Potassium metabisulfite. 582.5449 Manganese citrate. 582.3640 Potassium sorbate. 582.5452 Manganese gluconate. 582.3660 Propyl gallate. 582.5455 Manganese glycerophosphate. 582.3670 Propylparaben. 582.5458 Manganese hypophosphite. 582.3731 Sodium ascorbate. 582.5461 Manganese sulfate. 582.3733 Sodium benzoate. 582.5464 Manganous oxide. 582.5470 Mannitol. 582.3739 Sodium bisulfite. 582.5475 Methionine. 582.3766 Sodium metabisulfite. 582.5477 Methionine hydroxy analog and its 582.3784 Sodium propionate. calcium salts. 582.3795 Sodium sorbate. 582.5530 Niacin. 582.3798 Sodium sulfite. 582.5535 Niacinamide. 582.3845 Stannous chloride. 582.5580 D-Pantothenyl alcohol. 582.3862 Sulfur dioxide. 582.5590 Phenylalanine. 582.3890 Tocopherols. 582.5622 Potassium chloride. 582.5628 Potassium glycerophosphate. Subpart E—Emulsifying Agents 582.5634 Potassium iodide. 582.5650 Proline. 582.4101 Diacetyl tartaric acid esters of 582.5676 Pyridoxine hydrochloride. mono- and diglycerides of edible fats or 582.5695 Riboflavin. oils, or edible fat-forming fatty acids. 582.5697 Riboflavin-5-phosphate. 582.4505 Mono- and diglycerides of edible 582.5701 Serine. fats or oils, or edible fat-forming acids. 582.5772 Sodium pantothenate. 582.4521 Monosodium phosphate derivatives 582.5778 Sodium phosphate. of mono- and diglycerides of edible fats 582.5835 Sorbitol. or oils, or edible fat-forming fatty acids. 582.5875 Thiamine hydrochloride. 582.4666 Propylene glycol. 582.5878 Thiamine mononitrate.

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582.5881 Threonine. Subpart A—General Provisions 582.5890 Tocopherols. 582.5892 a-Tocopherol acetate. § 582.1 Substances that are generally 582.5915 Tryptophane. recognized as safe. 582.5920 Tyrosine. 582.5925 Valine. (a) It is impracticable to list all sub- 582.5930 Vitamin A. stances that are generally recognized 582.5933 Vitamin A acetate. as safe for their intended use. However, 582.5936 Vitamin A palmitate. by way of illustration, the Commis- 582.5945 Vitamin B12. sioner regards such common food in- 582.5950 Vitamin D . 2 gredients as salt, pepper, sugar, vin- 582.5953 Vitamin D3. 582.5985 Zinc chloride. egar, baking powder, and monosodium 582.5988 Zinc gluconate. glutamate as safe for their intended 582.5991 Zinc oxide. use. The lists in subparts B through H 582.5994 Zinc stearate. of this part include additional sub- 582.5997 Zinc sulfate. stances that, when used for the pur- Subpart G—Sequestrants poses indicated, in accordance with good manufacturing or feeding prac- 582.6033 Citric acid. tice, are regarded by the Commissioner 582.6085 Sodium acid phosphate. as generally recognized as safe for such 582.6099 Tartaric acid. uses. 582.6185 Calcium acetate. 582.6193 Calcium chloride. (b) For the purposes of this section, 582.6195 Calcium citrate. good manufacturing or feeding practice 582.6197 Calcium diacetate. shall be defined to include the fol- 582.6199 Calcium gluconate. lowing restrictions: 582.6203 Calcium hexametaphosphate. (1) The quantity of a substance added 582.6215 Monobasic calcium phosphate. to animal food does not exceed the 582.6219 Calcium phytate. amount reasonably required to accom- 582.6285 Dipotassium phosphate. 582.6290 Disodium phosphate. plish its intended physical, nutritional, 582.6386 Isopropyl citrate. or other technical effect in food; and 582.6511 Monoisopropyl citrate. (2) The quantity of a substance that 582.6625 Potassium citrate. becomes a component of animal food as 582.6751 Sodium citrate. a result of its use in the manufac- 582.6754 Sodium diacetate. turing, processing, or packaging of 582.6757 Sodium gluconate. food, and which is not intended to ac- 582.6760 Sodium hexametaphosphate. complish any physical or other tech- 582.6769 Sodium metaphosphate. 582.6778 Sodium phosphate. nical effect in the food itself, shall be 582.6787 Sodium pyrophosphate. reduced to the extent reasonably pos- 582.6789 Tetra sodium pyrophosphate. sible. 582.6801 Sodium tartrate. (3) The substance is of appropriate 582.6804 Sodium potassium tartrate. grade and is prepared and handled as a 582.6807 Sodium thiosulfate. food ingredient. Upon request the Com- 582.6810 Sodium tripolyphosphate. missioner will offer an opinion, based 582.6851 Stearyl citrate. on specifications and intended use, as Subpart H—Stabilizers to whether or not a particular grade or lot of the substance is of suitable pu- 582.7115 Agar-agar. rity for use in food and would generally 582.7133 Ammonium alginate. be regarded as safe for the purpose in- 582.7187 Calcium alginate. 582.7255 Chondrus extract. tended, by experts qualified to evaluate 582.7330 Gum arabic. its safety. 582.7333 Gum ghatti. (c) The inclusion of substances in the 582.7339 Guar gum. list of nutrients does not constitute a 582.7343 Locust bean gum. finding on the part of the Department 582.7349 Sterculia gum. that the substance is useful as a sup- 582.7351 Gum tragacanth. plement to the diet for animals. 582.7610 Potassium alginate. (d) Substances that are generally rec- 582.7724 Sodium alginate. ognized as safe for their intended use AUTHORITY: 21 U.S.C. 321, 342, 348, 371. within the meaning of section 409 of SOURCE: 41 FR 38657, Sept. 10, 1976, unless the Act are listed in subparts B otherwise noted. through H of this part. When the status

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of a substance has been reevaluated will not affect its status for other uses and affirmed as GRAS or deleted from not specified in the referenced regula- subparts B through H of this part, an tion, pending a specific review of such appropriate explanation will be noted, other uses. e.g., ‘‘affirmed as GRAS,’’ ‘‘food additive regulation,’’ ‘‘interim food addi- § 582.10 Spices and other natural tive regulation,’’ or ‘‘prohibited from seasonings and flavorings. use in food,’’ with a reference to the Spices and other natural seasonings appropriate new regulation. Such nota- and flavorings that are generally rection will apply only to the specific use ognized as safe for their intended use, covered by the review, e.g., direct animal food use and/or indirect animal within the meaning of section 409 of food use and/or animal feed use and 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. 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.

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Common name Botanical name of plant source

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. 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.

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Common name Botanical name of plant source

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. 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.

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Common name Botanical name of plant source

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. 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.

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Common name Botanical name of plant source

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. 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 Aconitic acid (equisetic acid, citridic acid, and adjuvants. achilleic acid). Anethole (parapropenyl anisole). Synthetic flavoring substances and Benzaldehyde (benzoic aldehyde). adjuvants that are generally recog- N-Butyric acid (butanoic acid). nized as safe for their intended use, d- or l-Carvone (carvol). within the meaning of section 409 of Cinnamaldehyde (cinnamic aldehyde). the act, are as follows: Citral (2,6-dimethyloctadien-2,6-al-8, geranial, neral). Acetaldehyde (ethanal). Acetoin (acetyl methylcarbinol).

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Decanal (N-decylaldhehyde, capraldehyde, Element Source compounds capric aldehyde, caprinaldehyde, aldehyde C-10). Reduced iron. Diacetyl (2,3-butandeione). Ethyl acetate. Manganese ...... Manganese acetate. Ethyl butyrate. Manganese carbonate. Manganese citrate (soluble). 3-Methyl-3-phenyl glycidic acid ethyl ester Manganese chloride. (ethyl-methyl-phenyl-glycidate, so-called Manganese gluconate. strawberry aldehyde, C-16 aldehyde). Manganese orthophosphate. Ethyl vanillin. Manganese phosphate (dibasic). Eugenol. Manganese sulfate. Geraniol (3,7-dimethyl-2,6 and 3,6-octadien-1- Manganous oxide. Zinc ...... Zinc acetate. ol). Zinc carbonate. Geranyl acetate (geraniol acetate). Zinc chloride. Glycerol (glyceryl) tributyrate (tributyrin, Zinc oxide. butyrin). Zinc sulfate. Limonene (d-, l-, and dl-). Linalool (linalol, 3,7-dimethyl-1,6-octadien-3- § 582.99 Adjuvants for pesticide chemi- ol). cals. Linalyl acetate (bergamol). l-Malic acid. Adjuvants, identified and used in ac- Methyl anthranilate (methyl-2- cordance with 40 CFR 180.1001(c) and aminobenzoate). (d), which are added to pesticide use di- Piperonal (3,4-methylenedioxy-benzaldehyde, lutions by a grower or applicator prior heliotropin). to application to the raw agricultural Vanillin. commodity, are exempt from the re- § 582.80 Trace minerals added to ani- quirement of tolerances under section mal feeds. 409 of the act. These substances added to animal feeds as nutritional dietary supple- Subpart B—General Purpose Food ments are generally recognized as safe Additives when added at levels consistent with good feeding practice. 1 § 582.1005 Acetic acid. (a) Product. Acetic acid. Element Source compounds (b) Conditions of use. This substance Cobalt ...... Cobalt acetate. is generally recognized as safe when Cobalt carbonate. used in accordance with good manufac- Cobalt chloride. turing or feeding practice. Cobalt oxide. Cobalt sulfate. Copper ...... Copper carbonate. § 582.1009 Adipic acid. Copper chloride. (a) Product. Adipic acid. Copper gluconate. Copper hydroxide. (b) [Reserved] Copper orthophosphate. (c) Limitations, restrictions, or expla- Copper oxide. nation. This substance is generally rec- Copper pyrophosphate. Copper sulfate. ognized as safe when used as a buffer Iodine ...... Calcium iodate. and neutralizing agent in accordance Calcium iodobehenate. with good manufacturing or feeding Cuprous iodide. 3,5-Diiodosalicylic acid. practice. Ethylenediamine dihydroiodide. Potassium iodate. § 582.1033 Citric acid. Potassium iodide. Sodium iodate. (a) Product. Citric acid. Sodium iodide. (b) Conditions of use. This substance Thymol iodide. is generally recognized as safe when Iron ...... Iron ammonium citrate. used in accordance with good manufac- Iron carbonate. Iron chloride. turing or feeding practice. Iron gluconate. Iron oxide. § 582.1057 Hydrochloric acid. Iron phosphate. Iron pyrophosphate. (a) Product. Hydrochloric acid. Iron sulfate. (b) [Reserved] (c) Limitations, restrictions, or expla- 1 All substances listed may be in anhydrous nation. This substance is generally rec- or hydrated form. ognized as safe when used as a buffer

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and neutralizing agent in accordance used in accordance with good manufac- with good manufacturing or feeding turing or feeding practice. practice. § 582.1125 Aluminum sulfate. § 582.1061 Lactic acid. (a) Product. Aluminum sulfate. (a) Product. Lactic acid. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice. § 582.1127 Aluminum ammonium sul- § 582.1069 Malic acid. fate. (a) Product. Malic acid. (a) Product. Aluminum ammonium (b) Conditions of use. This substance sulfate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufac- § 582.1073 Phosphoric acid. turing or feeding practice. (a) Product. Phosphoric acid. § 582.1129 Aluminum potassium sul- (b) Conditions of use. This substance fate. is generally recognized as safe when used in accordance with good manufac- (a) Product. Aluminum potassium sul- turing or feeding practice. fate. (b) Conditions of use. This substance § 582.1077 Potassium acid tartrate. is generally recognized as safe when (a) Product. Potassium acid 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- § 582.1131 Aluminum sodium sulfate. turing or feeding practice. (a) Product. Aluminum sodium sulfate. § 582.1087 Sodium acid pyrophosphate. (b) Conditions of use. This substance (a) Product. Sodium acid 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- § 582.1135 Ammonium bicarbonate. turing or feeding practice. (a) Product. Ammonium bicarbonate. § 582.1091 Succinic acid. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Succinic 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- § 582.1137 Ammonium carbonate. turing or feeding practice. (a) Product. Ammonium carbonate. § 582.1095 Sulfuric acid. (b) Conditions of use. This substance (a) Product. Sulfuric acid. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufacturing or feeding practice. § 582.1139 Ammonium hydroxide. (a) Product. Ammonium hydroxide. § 582.1099 Tartaric acid. (b) Conditions of use. This substance (a) Product. Tartaric acid. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice.

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§ 582.1141 Ammonium phosphate. § 582.1205 Calcium hydroxide. (a) Product. Ammonium phosphate (a) Product. Calcium hydroxide. (mono- and dibasic). (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. § 582.1143 Ammonium sulfate. (a) Product. Calcium lactate. (a) Product. Ammonium 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. § 582.1210 Calcium oxide. § 582.1155 Bentonite. (a) Product. Calcium oxide. (a) Product. Bentonite. (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. § 582.1217 Calcium phosphate. § 582.1165 Butane. (a) Product. Calcium phosphate (a) Product. Butane. (mono-, di-, and tribasic). (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice. § 582.1235 Caramel. § 582.1191 Calcium carbonate. (a) Product. Caramel. (a) Product. Calcium carbonate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice. § 582.1240 Carbon dioxide. § 582.1193 Calcium chloride. (a) Product. Carbon dioxide. (a) Product. Calcium chloride. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice. § 582.1275 Dextrans. § 582.1195 Calcium citrate. (a) Product. Dextrans of average mo- (a) Product. Calcium citrate. lecular weight below 100,000. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

§ 582.1199 Calcium gluconate. § 582.1320 Glycerin. (a) Product. Calcium gluconate. (a) Product. Glycerin. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

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§ 582.1324 Glyceryl monostearate. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Glyceryl monostearate. 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- § 582.1500 Monoammonium glutamate. turing or feeding practice. (a) Product. Monoammonium glu- § 582.1355 Helium. tamate. (b) Conditions of use. This substance (a) Product. Helium. 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. § 582.1516 Monopotassium glutamate. § 582.1366 Hydrogen peroxide. (a) Product. Monopotassium glutamate. (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 § 582.1540 Nitrogen. manufacturing or feeding practice. (a) Product. Nitrogen. § 582.1400 Lecithin. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Lecithin. 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- § 582.1585 Papain. turing or feeding practice. (a) Product. Papain. (b) Conditions of use. This substance § 582.1425 Magnesium carbonate. is generally recognized as safe when (a) Product. Magnesium carbonate. 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- § 582.1613 Potassium bicarbonate. turing or feeding practice. (a) Product. Potassium bicarbonate. (b) Conditions of use. This substance § 582.1428 Magnesium hydroxide. is generally recognized as safe when (a) Product. Magnesium hydroxide. 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- § 582.1619 Potassium carbonate. turing or feeding practice. (a) Product. Potassium carbonate. (b) Conditions of use. This substance § 582.1431 Magnesium oxide. is generally recognized as safe when (a) Product. Magnesium 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- § 582.1625 Potassium citrate. turing or feeding practice. (a) Product. Potassium citrate. (b) Conditions of use. This substance § 582.1480 Methylcellulose. is generally recognized as safe when (a) Product. U.S.P. methylcellulose, used in accordance with good manufac- except that the methoxy content shall turing or feeding practice. not be less than 27.5 percent and not more than 31.5 percent on a dry-weight § 582.1631 Potassium hydroxide. basis. (a) Product. Potassium hydroxide.

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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.

§ 582.1643 Potassium sulfate. § 582.1742 Sodium carbonate. (a) Product. Potassium sulfate. (a) Product. Sodium 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. § 582.1655 Propane. § 582.1745 Sodium (a) Product. Propane. carboxymethylcellulose. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Sodium carboxymethyl- used in accordance with good manufac- cellulose is the sodium salt of turing or feeding practice. carboxymethylcellulose not less than 99.5 percent on a dry-weight basis, with § 582.1666 Propylene glycol. maximum substitution of 0.95 (a) Product. Propylene glycol. carboxymethyl groups per (b) Conditions of use. This substance anhydroglucose unit, and with a min- is generally recognized as safe (except imum viscosity of 25 centipoises for 2 in cat food) when used in accordance percent by weight aqueous solution at with good manufacturing or feeding 25 °C. practice. (b) Conditions of use. This substance is generally recognized as safe when [41 FR 38657, Sept. 10, 1976, as amended at 61 FR 19544, May 2, 1996] used in accordance with good manufacturing or feeding practice. § 582.1685 Rennet. § 582.1748 Sodium caseinate. (a) Product. Rennet (rennin). (b) Conditions of use. This substance (a) Product. Sodium caseinate. 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. § 582.1711 Silica aerogel. (a) Product. Silica aerogel as a finely § 582.1751 Sodium citrate. powdered microcellular silica foam (a) Product. Sodium citrate. having a minimum silica content of (b) Conditions of use. This substance 89.5 percent. 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 compo- § 582.1763 Sodium hydroxide. nent of antifoaming agents in accordance with good manufacturing or feed- (a) Product. Sodium hydroxide. ing practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.1721 Sodium acetate. used in accordance with good manufac- (a) Product. Sodium acetate. 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. (b) Conditions of use. This substance is generally recognized as safe when § 582.1736 Sodium bicarbonate. used in accordance with good manufac- (a) Product. Sodium bicarbonate. turing or feeding practice.

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§ 582.1778 Sodium phosphate. (b) Conditions of use. This substance (a) Product. Sodium phosphate is generally recognized as safe when (mono-, di-, and tribasic). used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when § 582.1978 Carnauba wax. used in accordance with good manufacturing or feeding practice. (a) Product. Carnauba wax. (b) Conditions of use. This substance § 582.1781 Sodium aluminum phos- is generally recognized as safe when phate. used in accordance with good manufac- (a) Product. Sodium aluminum phos- turing or feeding practice. phate. (b) Conditions of use. This substance Subpart C—Anticaking Agents is generally recognized as safe when used in accordance with good manufac- § 582.2122 Aluminum calcium silicate. turing or feeding practice. (a) Product. Aluminum calcium silicate. § 582.1792 Sodium sesquicarbonate. (b) Tolerance. 2 percent. (a) Product. Sodium sesquicarbonate. (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 table salt used in accordance with good manufac- in accordance with good manufacturing turing or feeding practice. or feeding practice.

§ 582.1804 Sodium potassium tartrate. § 582.2227 Calcium silicate. (a) Product. Sodium potassium tar- (a) Product. Calcium silicate. trate. (b) Tolerance. 2 percent and 5 percent. (b) Conditions of use. This substance (c) Limitations, restrictions, or expla- is generally recognized as safe when nation. This substance is generally rec- used in accordance with good manufac- ognized as safe when used at levels not turing or feeding practice. exceeding 2 percent in table salt and 5 percent in baking powder in accordance § 582.1810 Sodium tripolyphosphate. with good manufacturing or feeding (a) Product. Sodium practice. tripolyphosphate. (b) Conditions of use. This substance § 582.2437 Magnesium silicate. is generally recognized as safe when (a) Product. Magnesium silicate. used in accordance with good manufac- (b) Tolerance. 2 percent. turing or feeding practice. (c) Limitations, restrictions, or explanation. This substance is generally rec- § 582.1901 Triacetin. ognized as safe when used in table salt (a) Product. Triacetin (glyceryl in accordance with good manufacturing triacetate). or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.2727 Sodium aluminosilicate. used in accordance with good manufac- (a) Product. Sodium aluminosilicate turing or feeding practice. (sodium silicoaluminate). (b) Tolerance. This substance is gen- § 582.1973 Beeswax. erally recognized as safe for use at a (a) Product. Beeswax (yellow wax). level not exceeding 2 percent in accord- (b) Conditions of use. This substance ance with good manufacturing or feed- is generally recognized as safe when ing practice. used in accordance with good manufacturing or feeding practice. § 582.2729 Hydrated sodium calcium aluminosilicate. § 582.1975 Bleached beeswax. (a) Product. Hydrated sodium calcium (a) Product. Bleached beeswax (white aluminosilicate (sodium calcium wax). silicoaluminate).

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(b) Tolerance. This substance is gen- when the total content of antioxidants erally recognized as safe for use at a is not over 0.02 percent of fat or oil level not exceeding 2 percent in accord- content including essential (volatile) ance with good manufacturing or feed- oil content of the food, provided the ing practice. substance is used in accordance with good manufacturing or feeding prac- § 582.2906 Tricalcium silicate. tice. (a) Product. Tricalcium silicate. (b) Tolerance. 2 percent. § 582.3149 Ascorbyl palmitate. (c) Limitations, restrictions, or expla- (a) Product. Ascorbyl palmitate. nation. This substance is generally rec- (b) Conditions of use. This substance ognized as safe when used in table salt is generally recognized as safe when in accordance with good manufacturing used in accordance with good manufac- or feeding practice. turing or feeding practice.

Subpart D—Chemical § 582.3169 Butylated hydroxyanisole. Preservatives (a) Product. Butylated hydroxyanisole. § 582.3013 Ascorbic acid. (b) Tolerance. This substance is generally recognized as safe for use in food (a) Product. Ascorbic acid. when the total content of antioxidants (b) Conditions of use. This substance is not over 0.02 percent of fat or oil is generally recognized as safe when content, including essential (volatile) used in accordance with good manufac- oil content of food provided the sub- turing or feeding practice. stance is used in accordance with good § 582.3021 Benzoic acid. manufacturing or feeding practice. (a) Product. Benzoic acid. § 582.3173 Butylated hydroxytoluene. (b) Tolerance. This substance is gen- (a) Product. Butylated hydroxytol- erally recognized as safe for use at a uene. level not exceeding 0.1 percent in ac- (b) Tolerance. This substance is gen- cordance with good manufacturing or erally recognized as safe for use in food feeding practice. when the total content of antioxidants is not over 0.02 percent of fat or oil § 582.3041 Erythorbic acid. content, including essential (volatile) (a) Product. Erythorbic acid. oil content of food provided the sub- (b) Conditions of use. This substance stance is used in accordance with good is generally recognized as safe when manufacturing or feeding practice. used in accordance with good manufacturing or feeding practice. § 582.3189 Calcium ascorbate. (a) Product. Calcium ascorbate. § 582.3081 Propionic acid. (b) Conditions of use. This substance (a) Product. Propionic acid. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufacturing or feeding practice. § 582.3221 Calcium propionate. (a) Product. Calcium propionate. § 582.3089 Sorbic acid. (b) Conditions of use. This substance (a) Product. Sorbic acid. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufacturing or feeding practice. § 582.3225 Calcium sorbate. (a) Product. Calcium sorbate. § 582.3109 Thiodipropionic acid. (b) Conditions of use. This substance (a) Product. Thiodipropionic acid. is generally recognized as safe when (b) Tolerance. This substance is gen- used in accordance with good manufac- erally recognized as safe for use in food turing or feeding practice.

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§ 582.3280 Dilauryl thiodipropionate. used in accordance with good manufacturing or feeding practice. (a) Product. Dilauryl thiodipropionate. § 582.3660 Propyl gallate. (b) Tolerance. This substance is generally recognized as safe for use in food (a) Product. Propyl gallate. when the total content of antioxidants (b) Tolerance. This substance is gen- is not over 0.02 percent of fat or oil erally recognized as safe for use in food content, including essential (volatile) when the total content of antioxidants oil content of the food, provided the is not over 0.02 percent of fat or oil substance is used in accordance with content, including essential (volatile) good manufacturing or feeding prac- oil content of the food, provided the tice. substance is used in accordance with good manufacturing or feeding prac- § 582.3336 Gum guaiac. tice. (a) Product. Gum guaiac. § 582.3670 Propylparaben. (b) Tolerance. 0.1 percent (equivalent antioxidant activity 0.01 percent). (a) Product. Propylparaben (propyl p- (c) Limitations, restrictions, or expla- hydroxybenzoate). nation. This substance is generally rec- (b) Tolerance. This substance is gen- ognized as safe when used in edible fats erally recognized as safe for use at a or oils in accordance with good manu- level not exceeding 0.1 percent in ac- facturing or feeding practice. cordance with good manufacturing or feeding practice. § 582.3490 Methylparaben. § 582.3731 Sodium ascorbate. (a) Product. Methylparaben (methyl p-hydroxybenzoate). (a) Product. Sodium ascorbate. (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 0.1 percent in ac- used in accordance with good manufac- cordance with good manufacturing or turing or feeding practice. feeding practice. § 582.3733 Sodium benzoate. § 582.3616 Potassium bisulfite. (a) Product. Sodium benzoate. (a) Product. Potassium bisulfite. (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 § 582.3739 Sodium bisulfite. in meats or in food recognized as (a) Product. Sodium bisulfite. source of vitamin B1. (b) [Reserved] (c) Limitations, restrictions, or expla- § 582.3637 Potassium metabisulfite. nation. This substance is generally rec- (a) Product. Potassium metabisulfite. ognized as safe when used in accord- (b) [Reserved] ance with good manufacturing or feed- (c) Limitations, restrictions, or expla- ing practice, except that it is not used nation. This substance is generally rec- in meats or in food recognized as ognized as safe when used in accord- source of vitamin B1. ance with good manufacturing or feeding practice, except that it is not used § 582.3766 Sodium metabisulfite. in meats or in food recognized as (a) Product. Sodium metabisulfite. source of vitamin B1. (b) [Reserved] (c) Limitations, restrictions, or expla- § 582.3640 Potassium sorbate. nation. This substance is generally rec- (a) Product. Potassium sorbate. ognized as safe when used in accord- (b) Conditions of use. This substance ance with good manufacturing or feed- is generally recognized as safe when ing practice, except that it is not used

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in meats or in food recognized as Subpart E—Emulsifying Agents source of vitamin B1. § 582.4101 Diacetyl tartaric acid esters § 582.3784 Sodium propionate. of mono- and diglycerides of edible fats or oils, or edible fat-forming (a) Product. Sodium propionate. fatty acids. (b) Conditions of use. This substance (a) Product. Diacetyl tartaric acid is generally recognized as safe when esters of mono- and diglycerides of edi- used in accordance with good manufac- ble fats or oils, or edible fat-forming turing or feeding practice. fatty acids. (b) Conditions of use. This substance § 582.3795 Sodium sorbate. is generally recognized as safe when (a) Product. Sodium sorbate. 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- § 582.4505 Mono- and diglycerides of turing or feeding practice. edible fats or oils, or edible fat- forming acids. § 582.3798 Sodium sulfite. (a) Product. Mono- and diglycerides of edible fats or oils, or edible fat-forming (a) Product. Sodium sulfite. acids. (b) [Reserved] (b) Conditions of use. This substance (c) Limitations, restrictions, or expla- is generally recognized as safe when nation. This substance is generally rec- used in accordance with good manufac- ognized as safe when used in accord- turing or feeding practice. ance with good manufacturing or feeding practice, except that it is not used § 582.4521 Monosodium phosphate de- in meats or in food recognized as rivatives of mono- and diglycerides source of vitamin B . of edible fats or oils, or edible fat- 1 forming fatty acids. § 582.3845 Stannous chloride. (a) Product. Monosodium phosphate derivatives of mono- and diglycerides (a) Product. Stannous chloride. of edible fats or oils, or edible fat-form- (b) Tolerance. This substance is gen- ing fatty acids. erally recognized as safe for use at a (b) Conditions of use. This substance level not exceeding 0.0015 percent cal- is generally recognized as safe when culated as tin in accordance with good used in accordance with good manufac- manufacturing or feeding practice. turing or feeding practice.

§ 582.3862 Sulfur dioxide. § 582.4666 Propylene glycol. (a) Product. Sulfur dioxide. (a) Product. Propylene glycol. (b) [Reserved] (b) Conditions of use. This substance (c) Limitations, restrictions, or expla- is generally recognized as safe when nation. This substance is generally rec- used in accordance with good manufac- ognized as safe when used in accord- turing or feeding practice. ance with good manufacturing or feeding practice, except that it is not used Subpart F—Nutrients and/or in meats or in food recognized as Dietary Supplements 1 source of vitamin B . 1 § 582.5013 Ascorbic acid. § 582.3890 Tocopherols. (a) Product. Ascorbic acid. (a) Product. Tocopherols. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when 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. 1 Amino acids listed in this subpart may be free hydrochloride salt, hydrated, or anhydrous form, where applicable.

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§ 582.5017 Aspartic acid. § 582.5195 Calcium citrate. (a) Product. Aspartic acid (L- and DL- (a) Product. Calcium citrate. 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. § 582.5201 Calcium glycerophosphate. § 582.5049 Aminoacetic acid. (a) Product. Calcium (a) Product. Glycine (aminoacetic glycerophosphate. acid). (b) Conditions of use. This substance (b) [Reserved] is generally recognized as safe when (c) Limitations, restrictions, or expla- used in accordance with good manufac- nation. This substance is generally rec- turing or feeding practice. ognized as safe when used in animal § 582.5210 Calcium oxide. feeds in accordance with good manufacturing or feeding practice. (a) Product. Calcium oxide. (b) Conditions of use. This substance § 582.5065 Linoleic acid. is generally recognized as safe when used in accordance with good manufac- (a) Product. Linoleic acid prepared turing or feeding practice. from edible fats and oils and free from chick-edema factor. § 582.5212 Calcium pantothenate. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Calcium pantothenate. used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when used in accordance with good manufac- § 582.5118 Alanine. turing or feeding practice. (a) Product. Alanine (L- and DL- § 582.5217 Calcium phosphate. forms). (a) Product. Calcium 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 manufac- § 582.5145 Arginine. turing or feeding practice. (a) Product. Arginine (L- and DL- § 582.5223 Calcium pyrophosphate. forms). (a) Product. Calcium 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.

§ 582.5159 Biotin. § 582.5230 Calcium sulfate. (a) Product. Biotin. (a) Product. Calcium 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.

§ 582.5191 Calcium carbonate. § 582.5245 Carotene. (a) Product. Calcium carbonate. (a) Product. Carotene. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing or feeding practice. turing or feeding practice.

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§ 582.5250 Choline bitartrate. used in accordance with good manufacturing or feeding practice. (a) Product. Choline bitartrate. (b) Conditions of use. This substance § 582.5308 Ferrous gluconate. is generally recognized as safe when used in accordance with good manufac- (a) Product. Ferrous gluconate. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.5252 Choline chloride. used in accordance with good manufacturing or feeding practice. (a) Product. Choline chloride. (b) Conditions of use. This substance § 582.5311 Ferrous lactate. is generally recognized as safe when 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 § 582.5260 Copper gluconate. used in accordance with good manufac- (a) Product. Copper gluconate. turing or feeding practice. (b) Tolerance. This substance is gen- § 582.5315 Ferrous sulfate. erally recognized as safe for use at a level not exceeding 0.005 percent in ac- (a) Product. Ferrous sulfate. cordance with good manufacturing or (b) Conditions of use. This substance feeding practice. is generally recognized as safe when used in accordance with good manufac- § 582.5271 Cysteine. turing or feeding practice. (a) Product. Cysteine (L-forms). § 582.5361 Histidine. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Histidine (L- and DL- used in accordance with good manufac- forms). turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.5273 Cystine. used in accordance with good manufac- (a) Product. Cystine (L- and DL- turing or feeding practice. forms). § 582.5370 Inositol. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Inositol. used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when used in accordance with good manufac- § 582.5301 Ferric phosphate. turing or feeding practice. (a) Product. Ferric phosphate. § 582.5375 Iron reduced. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Iron reduced. used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when used in accordance with good manufac- § 582.5304 Ferric pyrophosphate. turing or feeding practice. (a) Product. Ferric pyrophosphate. § 582.5381 Isoleucine. (b) Conditions of use. This substance 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 § 582.5306 Ferric sodium used in accordance with good manufac- pyrophosphate. turing or feeding practice. (a) Product. Ferric sodium pyrophosphate. § 582.5406 Leucine. (b) Conditions of use. This substance (a) Product. Leucine (L- and DL- is generally recognized as safe when forms).

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(b) Conditions of use. This substance § 582.5455 Manganese is generally recognized as safe when glycerophosphate. used in accordance with good manufac- (a) Product. Manganese turing or feeding practice. glycerophosphate. (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 § 582.5458 Manganese hypophosphite. used in accordance with good manufac- (a) Product. Manganese turing or feeding practice. hypophosphite. (b) Conditions of use. This substance § 582.5431 Magnesium oxide. is generally recognized as safe when (a) Product. Magnesium oxide. used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when § 582.5461 Manganese sulfate. used in accordance with good manufacturing or feeding practice. (a) Product. Manganese sulfate. (b) Conditions of use. This substance § 582.5434 Magnesium phosphate. is generally recognized as safe when used in accordance with good manufac- (a) Product. Magnesium phosphate turing or feeding practice. (di- and tribasic). (b) Conditions of use. This substance § 582.5464 Manganous oxide. 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 § 582.5443 Magnesium sulfate. used in accordance with good manufacturing or feeding practice. (a) Product. Magnesium sulfate. (b) Conditions of use. This substance § 582.5470 Mannitol. 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- § 582.5446 Manganese chloride. turing or feeding practice. (a) Product. Manganese chloride. (b) Conditions of use. This substance § 582.5475 Methionine. is generally recognized as safe when (a) Product. Methionine. used in accordance with good manufac- (b) [Reserved] turing or feeding practice. (c) Limitations, restrictions, or explanation. This substance is generally rec- § 582.5449 Manganese citrate. ognized as safe when used in animal (a) Product. Manganese citrate. feeds in accordance with good manu- (b) Conditions of use. This substance facturing or feeding practice. is generally recognized as safe when § 582.5477 Methionine hydroxy analog used in accordance with good manufac- and its calcium salts. turing or feeding practice. (a) Product. Methionine hydroxy ana- § 582.5452 Manganese gluconate. log and its calcium salts. (b) [Reserved] (a) Product. Manganese gluconate. (c) Limitations, restrictions, or expla- (b) Conditions of use. This substance nation. This substance is generally rec- is generally recognized as safe when ognized as safe when used in animal used in accordance with good manufac- feeds in accordance with good manu- turing or feeding practice. facturing or feeding practice.

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§ 582.5530 Niacin. (b) Conditions of use. This substance (a) Product. Niacin. 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- § 582.5676 Pyridoxine hydrochloride. turing or feeding practice. (a) Product. Pyridoxine hydro- § 582.5535 Niacinamide. chloride. (a) Product. Niacinamide. (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. § 582.5695 Riboflavin. § 582.5580 D-Pantothenyl alcohol. (a) Product. Riboflavin. (a) Product. D-Pantothenyl alcohol. (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. § 582.5590 Phenylalanine. (a) Product. Riboflavin-5-phosphate. (a) Product. Phenylalanine (L- and (b) Conditions of use. This substance DL-forms). is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufacturing or feeding practice. § 582.5701 Serine. (a) Product. Serine (L- and DL-forms). § 582.5622 Potassium chloride. (b) Conditions of use. This substance (a) Product. Potassium chloride. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufacturing or feeding practice. § 582.5772 Sodium pantothenate. (a) Product. Sodium pantothenate. § 582.5628 Potassium (b) Conditions of use. This substance glycerophosphate. is generally recognized as safe when (a) Product. Potassium used in accordance with good manufac- glycerophosphate. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.5778 Sodium phosphate. used in accordance with good manufac- (a) Product. Sodium phosphate turing or feeding practice. (mono-, di-, and tribasic). (b) Conditions of use. This substance § 582.5634 Potassium iodide. is generally recognized as safe when (a) Product. Potassium iodide. used in accordance with good manufac- (b) Tolerance. 0.01 percent. turing or feeding practice. (c) Limitations, restrictions, or explanation. This substance is generally rec- § 582.5835 Sorbitol. ognized as safe when used in table salt (a) Product. Sorbitol. as a source of dietary iodine in accord- (b) Conditions of use. This substance ance with good manufacturing or feed- is generally recognized as safe when ing practice. used in accordance with good manufacturing or feeding practice. § 582.5650 Proline. (a) Product. Proline (L- and DL- § 582.5875 Thiamine hydrochloride. forms). (a) Product. Thiamine hydrochloride.

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(b) Conditions of use. This substance § 582.5930 Vitamin A. is generally recognized as safe when (a) Product. Vitamin A. 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- § 582.5878 Thiamine mononitrate. turing or feeding practice. (a) Product. Thiamine mononitrate. (b) Conditions of use. This substance § 582.5933 Vitamin A acetate. is generally recognized as safe when (a) Product. Vitamin A 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- § 582.5881 Threonine. turing or feeding practice. (a) Product. Threonine (L- and DL- forms). § 582.5936 Vitamin A palmitate. (b) Conditions of use. This substance (a) Product. Vitamin A palmitate. 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. § 582.5890 Tocopherols. § 582.5945 Vitamin B . (a) Product. Tocopherols. 2 (b) Conditions of use. This substance (a) Product. Vitamin B12. 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. § 582.5892 a-Tocopherol acetate. § 582.5950 Vitamin D2. (a) Product. a-Tocopherol acetate. (a) Product. Vitamin D . (b) Conditions of use. This substance 2 (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. § 582.5915 Tryptophane. § 582.5953 Vitamin D2. (a) Product. Tryptophane (L- and DL- (a) Product. Vitamin D3. 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. § 582.5985 Zinc chloride. § 582.5920 Tyrosine. (a) Product. Zinc chloride. (a) Product. Tyrosine (L- and DL- (b) Conditions of use. This substance forms). is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufacturing or feeding practice. § 582.5988 Zinc gluconate. (a) Product. Zinc gluconate. § 582.5925 Valine. (b) Conditions of use. This substance (a) Product. Valine (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- § 582.5991 Zinc oxide. turing or feeding practice. (a) Product. Zinc oxide.

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§ 582.5994 Zinc stearate. § 582.6195 Calcium citrate. (a) Product. Zinc stearate prepared (a) Product. Calcium citrate. from stearic acid free from chick- (b) Conditions of use. This substance edema factor. 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. § 582.6197 Calcium diacetate. § 582.5997 Zinc sulfate. (a) Product. Calcium diacetate. (b) Conditions of use. This substance (a) Zinc sulfate. Product. is generally recognized as safe when (b) This substance Conditions of use. 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. § 582.6199 Calcium gluconate. Subpart G—Sequestrants 2 (a) Product. Calcium gluconate. (b) Conditions of use. This substance § 582.6033 Citric acid. is generally recognized as safe when used in accordance with good manufac- (a) Product. Citric acid. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.6203 Calcium used in accordance with good manufac- hexametaphosphate. turing or feeding practice. (a) Product. Calcium § 582.6085 Sodium acid phosphate. hexametaphosphate. (b) Conditions of use. This substance (a) Product. Sodium acid phosphate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufacturing or feeding practice. § 582.6215 Monobasic calcium phosphate. § 582.6099 Tartaric acid. (a) Product. Monobasic calcium phos- (a) Product. Tartaric acid. phate. (b) Conditions of use. This substance 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. § 582.6185 Calcium acetate. § 582.6219 Calcium phytate. (a) Product. Calcium acetate. (b) Conditions of use. This substance (a) Product. Calcium phytate. 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. § 582.6193 Calcium chloride. (a) Product. Calcium chloride. § 582.6285 Dipotassium phosphate. (a) Product. Dipotassium phosphate. 2 For the purpose of this subpart, no at- (b) Conditions of use. This substance tempt has been made to designate those is generally recognized as safe when sequestrants that may also function as used in accordance with good manufac- chemical preservatives. turing or feeding practice.

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§ 582.6290 Disodium phosphate. (b) Conditions of use. This substance (a) Product. Disodium phosphate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing or feeding practice. used in accordance with good manufac- § 582.6769 Sodium metaphosphate. turing or feeding practice. (a) Product. Sodium metaphosphate. § 582.6386 Isopropyl citrate. (b) Conditions of use. This substance (a) Product. Isopropyl citrate. is generally recognized as safe when (b) Tolerance. This substance is gen- used in accordance with good manufac- erally recognized as safe for use at a turing or feeding practice. level not exceeding 0.02 percent in ac- § 582.6778 Sodium phosphate. cordance with good manufacturing or feeding practice. (a) Product. Sodium phosphate (mono-, di-, and tribasic). § 582.6511 Monoisopropyl citrate. (b) Conditions of use. This substance (a) Product. Monoisopropyl citrate. 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- § 582.6787 Sodium pyrophosphate. turing or feeding practice. (a) Product. Sodium pyrophosphate. § 582.6625 Potassium citrate. (b) Condition of use. This substance is (a) Product. Potassium citrate. generally recognized as safe when used (b) Conditions of use. This substance in accordance with good manufacturing is generally recognized as safe when or feeding practice. used in accordance with good manufac- § 582.6789 Tetra sodium turing or feeding practice. pyrophosphate. [41 FR 38657, Sept. 10, 1976. Redesignated at (a) Product. Tetra sodium 42 FR 14091, Mar. 15, 1977] pyrophosphate. (b) Conditions of use. This substance § 582.6751 Sodium citrate. is generally recognized as safe when (a) Product. Sodium citrate. used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when used in accordance with good manufac- § 582.6801 Sodium tartrate. turing or feeding practice. (a) Product. Sodium tartrate. [41 FR 38657, Sept. 10, 1976. Redesignated at (b) Conditions of use. This substance 42 FR 14091, Mar. 15, 1977] is generally recognized as safe when used in accordance with good manufac- § 582.6754 Sodium diacetate. turing or feeding practice. (a) Product. Sodium diacetate. (b) Conditions of use. This substance § 582.6804 Sodium potassium tartrate. is generally recognized as safe when (a) Product. Sodium potassium tar- used in accordance with good manufac- trate. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.6757 Sodium gluconate. used in accordance with good manufac- (a) Product. Sodium gluconate. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.6807 Sodium thiosulfate. used in accordance with good manufac- (a) Product. Sodium thiosulfate. turing or feeding practice. (b) Tolerance. 0.1 percent. (c) Limitations, restrictions, or expla- § 582.6760 Sodium nation. This substance is generally rec- hexametaphosphate. ognized as safe when used in salt in ac- (a) Product. Sodium cordance with good manufacturing or hexametaphosphate. feeding practice.

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§ 582.6810 Sodium tripolyphosphate. used in accordance with good manufac- (a) Product. Sodium turing or feeding practice. tripolyphosphate. (b) Conditions of use. This substance § 582.7339 Guar gum. is generally recognized as safe when (a) Product. Guar gum. 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- § 582.6851 Stearyl citrate. turing or feeding practice. (a) Product. Stearyl citrate. (b) Tolerance. This substance is gen- § 582.7343 Locust bean gum. erally recognized as safe for use at a (a) Product. Locust (carob) bean gum. level not exceeding 0.15 percent in ac- (b) Conditions of use. This substance cordance with good manufacturing or is generally recognized as safe when feeding practice. used in accordance with good manufac- Subpart H—Stabilizers turing or feeding practice. § 582.7349 Sterculia gum. § 582.7115 Agar-agar. (a) Product. Agar-agar. (a) Product. Sterculia gum (karaya (b) Conditions of use. This substance gum). 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. § 582.7133 Ammonium alginate. (a) Product. Ammonium alginate. § 582.7351 Gum tragacanth. (b) Conditions of use. This substance (a) Product. Tragacanth (gum is generally recognized as safe when tragacanth). used in accordance with good manufac- (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when § 582.7187 Calcium alginate. used in accordance with good manufacturing or feeding practice. (a) Product. Calcium alginate. (b) Conditions of use. This substance § 582.7610 Potassium alginate. is generally recognized as safe when used in accordance with good manufac- (a) Product. Potassium alginate. turing or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when § 582.7255 Chondrus extract. used in accordance with good manufac- (a) Product. Chondrus extract turing or feeding practice. (carrageenin). (b) Conditions of use. This substance § 582.7724 Sodium alginate. is generally recognized as safe when (a) Product. Sodium alginate. 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 is generally recognized as safe when PART 584—FOOD SUBSTANCES AF- used in accordance with good manufac- FIRMED AS GENERALLY RECOG- turing or feeding practice. NIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS § 582.7333 Gum ghatti. (a) Product. Gum ghatti. Subpart A [Reserved] (b) Conditions of use. This substance is generally recognized as safe when

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Subpart B—Listing of Specific Substances ide after ignition. Not more than 3 ppm Affirmed as GRAS arsenic. Not more than 0.003 percent heavy metals (as lead). Not more than Sec. 584.200 Ethyl alcohol containing ethyl ace- 10 ppm lead. Not more than 7 percent tate. loss on drying. Not more than 8.5 per- 584.700 Hydrophobic silicas. cent loss on ignition after drying. Not 584.725 25-Hydroxyvitamin D3. more than 5 percent soluble ionizable AUTHORITY: 21 U.S.C. 321, 342, 348, 371. salts (as sodium sulfate). Not more than 1 percent insoluble substances. Not more than 50 parts per million Subpart A [Reserved] dichlorodimethylsilane. Subpart B—Listing of Specific [61 FR 43453, Aug. 23, 1996] Substances Affirmed as GRAS § 584.725 25-Hydroxyvitamin D3. § 584.200 Ethyl alcohol containing (a) Product. 25–Hydroxyvitamin D3 ethyl acetate. (9,10-secocholesta-5,7,10(19)-triene-3b, The feed additive ethyl alcohol con- 25-diol). taining ethyl acetate meets the re- (b) Conditions of use. This substance quirement of 27 CFR 21.62, being not is generally recognized as safe as a less than 92.5 percent ethyl alcohol, source of vitamin D3 activity in feed or each 100 gallons having had added the drinking water of broiler chickens equivalent of 4.25 gallons of 100 percent when used in accordance with the limi- ethyl acetate. It is used in accordance tations in paragraph (c) of this section. with good feeding practices in rumi- (c) Limitations. (1) Not to exceed 69 nant feed supplements as a source of parts per billion (ppb) in feed or 34.5 added energy. ppb in drinking water. It shall be used [46 FR 52333, Oct. 27, 1981, as amended at 72 in accordance with good manufacturing FR 41620, July 31, 2007] and feeding practices. (2) The product must comply with § 584.700 Hydrophobic silicas. the following specifications: (a) Product. Amorphous fumed hydro- (i) Not less than 94.0 percent 25- phobic silica or precipitated hydro- hydroxyvitamin D3. phobic silica (CAS Reg. No. 68611–0944– (ii) Not more than 1 percent of any 099, silane, dichlorodimethyl-, reaction individual sterol. products with silica). (iii) Not more than 5 percent water. (b) Conditions of use. An anticaking/ (iv) Not more than 20 parts per mil- free-flow agent in vitamin preparations lion (ppm) lead. for animal feed. (v) Not more than 20 ppm aluminum. (c) Limitations. Not to exceed 5 percent in the vitamin preparation. It (vi) Not more than 1.0 percent solvents and non-detectable levels of 2′. 4′. shall be used in accordance with good ′ ′ manufacturing or feeding practices. It 5 . 7 -tetraiodofluorescin. must be of purity suitable for intended (3) Product labeling shall bear the use, and it must comply with the fol- following: lowing specifications: (i) A statement to indicate that the (i) Amorphous fumed hydrophobic maximum use level of 25- silica: Not less than 99.0 percent silicon hydroxyvitamin D3 must not exceed 69 dioxide after ignition. Not more than 3 ppb in feed or 34.5 ppb in drinking ppm arsenic. Not more than 0.003 per- water. cent heavy metals (as lead). Not more (ii) Adequate use directions to ensure than 10 ppm lead. Not more than 2.5 that 25-hydroxyvitamin D3 (and all pre- percent loss on drying. Not more than mixes) is uniformly blended through- 2 percent loss on ignition after drying. out the feed or drinking water. Not more than 1 percent insoluble sub- (iii) An expiration date on all premix stances. Not more than 50 parts per labeling. million dichlorodimethylsilane. (iv) A statement on all premix label- (ii) Precipated hydrophobic silica: ing (feed and drinking water forms) Not less than 94.0 percent silicon diox- that 25-hydroxyvitamin D3 should not 602

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be used simultaneously in both feed formation. Any such petition shall in- and water. clude an adequate scientific basis to support the petition, shall be the form [72 FR 12564, Mar. 16, 2007] set forth in § 571.1 of this chapter, and will be published in the FEDERAL REG- PART 589—SUBSTANCES PROHIB- ISTER for comment if it contains rea- ITED FROM USE IN ANIMAL FOOD sonable ground. OR FEED [45 FR 28319, Apr. 29, 1980] Subpart A—General Provisions Subpart B—Listing of Specific Sub- Sec. 589.1 Substances prohibited from use in ani- stances Prohibited From Use mal food or feed. in Animal Food or Feed

Subpart B—Listing of Specific Substances § 589.1000 Gentian violet. Prohibited From Use in Animal Food or The Food and Drug Administration Feed has determined that gentian violet has 589.1000 Gentian violet. not been shown by adequate scientific 589.1001 Propylene glycol in or on cat food. data to be safe for use in animal feed. 589.2000 Animal proteins prohibited in rumi- Use of gentian violet in animal feed nant feed. causes the feed to be adulterated and in 589.2001 Cattle materials prohibited in ani- violation of the Federal Food, Drug, mal food or feed to prevent the transmission of bovine spongiform and Cosmetic Act (the act), in the ab- encephalopathy. sence of a regulation providing for its safe use as a food additive under sec- AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 371. tion 409 of the act, unless it is subject to an effective notice of claimed inves- Subpart A—General Provisions tigational exemption for a food additive under § 570.17 of this chapter, or § 589.1 Substances prohibited from use in animal food or feed. unless the substance is intended for use as a new animal drug and is subject to (a) The substances listed in this part an approved application under section have been prohibited from use in ani- 512 of the act, or an index listing under mal food or feed by the Food and Drug section 572 of the act, or an effective Administration because of a deter- notice of claimed investigational ex- mination that they present a potential emption for a new animal drug under risk to the public health or have not part 511 of this chapter or § 516.125 of been shown by adequate scientific data this chapter. to be safe for use in such food or feed. Use of any of these substances in viola- [72 FR 69131, Dec. 6, 2007] tion of this part causes the animal food or feed involved to be adulterated and § 589.1001 Propylene glycol in or on in violation of the Act. cat food. (b) This part includes only a partial The Food and Drug Administration list of substances prohibited from use has determined that propylene glycol in animal food or feed; it is for easy in or on cat food has not been shown by reference purposes and is not a com- adequate scientific data to be safe for plete list of substances that may not use. Use of propylene glycol in or on lawfully be used in such animal food or cat food causes the feed to be adulter- feed. No substance may be used in ani- ated and in violation of the Federal mal food or feed unless it meets all ap- Food, Drug, and Cosmetic Act (the plicable requirements of the Act. act), in the absence of a regulation pro- (c) The Food and Drug Administra- viding for its safe use as a food additive tion either on its own initiative or on under section 409 of the act, unless it is behalf of any interested person who has subject to an effective notice of submitted a petition, may publish a claimed investigational exemption for proposal to establish, amend, or repeal a food additive under § 570.17 of this a regulation under this part on the chapter, or unless the substance is in- basis of new scientific evaluation or intended for use as a new animal drug

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and is subject to an approved applica- order includes, but is not limited to, tion under section 512 of the act or an cattle, buffalo, sheep, goats, deer, elk, effective notice of claimed investiga- and antelopes. tional exemption for a new animal drug (b) Food additive status. The Food and under part 511 of this chapter. Drug Administration has determined [61 FR 19544, May 2, 1996] that protein derived from mammalian tissues for use in ruminant feed is a § 589.2000 Animal proteins prohibited food additive subject to section 409 of in ruminant feed. the Federal Food, Drug, and Cosmetic (a) Definitions—(1) Protein derived from Act (the act). The use or intended use mammalian tissues means any protein- in ruminant feed of any material that containing portion of mammalian ani- contains protein derived from mamma- mals, excluding: Blood and blood prod- lian tissues causes the feed to be adul- ucts; gelatin; tallow containing no terated and in violation of the act, un- more than 0.15 percent insoluble impu- less it is the subject of an effective no- rities and tallow derivatives as speci- tice of claimed investigational exemp- fied in § 589.2001; inspected meat prod- tion for a food additive under § 570.17 of ucts which have been cooked and of- this chapter. fered for human food and further heat (c) Requirements for renderers that are processed for feed (such as plate waste not included in paragraph (e) of this sec- and used cellulosic food casings); milk tion. (1) Renderers that manufacture products (milk and milk proteins); and products that contain or may contain any product whose only mammalian protein derived from mammalian tis- protein consists entirely of porcine or sues and that are intended for use in equine protein. animal feed shall take the following (2) Renderer means any firm or indi- measures to ensure that materials vidual that processes slaughter byprod- identified in paragraph (b) of this sec- ucts, animals unfit for human con- tion are not used in the feed of sumption, or meat scraps. The term in- ruminants: cludes persons who collect such mate- (i) Label the materials as follows: rials and subject them to minimal ‘‘Do not feed to cattle or other processing, or distribute them to firms ruminants’’; and other than renderers (as defined here) (ii) Maintain records sufficient to whose intended use for the products track the materials throughout their may include animal feed. The term in- receipt, processing, and distribution, cludes renderers that also blend animal and make the copies available for in- protein products. spection and copying by the Food and (3) Blender means any firm or indi- Drug Administration. vidual which obtains processed animal (2) Renderers described in paragraph protein from more than one source or (c)(1) of this section will be exempted from more than one species, and subse- from the requirements of paragraphs quently mixes (blends) or redistributes (c)(1)(i) and (c)(1)(ii) of this section if an animal protein product. they: (4) Feed manufacturer includes manu- (i) Use exclusively a manufacturing facturers of complete and intermediate method that has been validated by the feeds intended for animals, and in- Food and Drug Administration to de- cludes on-farm in addition to off-farm activate the agent that causes trans- feed manufacturing and mixing oper- missible spongiform encephalopathy ations. (TSE) and whose design has been made (5) Nonmammalian protein includes available to the public; proteins from nonmammalian animals. (ii) Use routinely a test method that (6) Distributor includes persons who has been validated by the Food and distribute or transport feeds or feed in- Drug Administration to detect the gredients intended for animals. presence of the agent that causes (7) Ruminant includes any member of TSE’s and whose design has been made the order of animals which has a stom- available to the public. Renderers ach with four chambers (rumen, reticu- whose products test positive for agents lum, omasum, and abomasum) through that cause TSE’s must comply with which feed passes in digestion. The paragraphs (c)(1)(i) and (c)(1)(ii) of this

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section. Records of the test results (i) Purchase animal protein products shall be made available for inspection that are marked in accordance with by the Food and Drug Administration; paragraph (c)(3) of this section or pur- or chase such materials from renderers (iii) Use exclusively a method for that certified compliance with para- controlling the manufacturing process graph (c)(3) of this section, or purchase that minimizes the risk of the TSE such materials from parties that cer- agent entering the product and whose tify that the materials were purchased design has been made available to the from renderers that certified compli- public and validated by the Food and ance with paragraph (c)(3) of this sec- Drug Administration. tion; or (3) Renderers described in paragraph (ii) Comply with the requirements of (c)(1) of this section will be exempted paragraph (c)(3) of this section where from the requirements of paragraph appropriate. (c)(1)(ii) of this section if they use a permanent method, approved by FDA, (4) Pet food products that are sold or to make a mark indicating that the are intended for sale at retail and feeds product contains or may contain pro- for nonruminant laboratory animals tein derived from mammalian tissue. If are exempt from the labeling require- the marking is by the use of an agent ments in paragraphs (c) and (d) of this that cannot be detected on visual in- section. However, if the pet food prod- spection, the renderer must use an ucts or feeds for nonruminant labora- agent whose presence can be detected tory animals are sold or are intended by a method that has been validated by for sale as distressed or salvage items, the Food and Drug Administration and then such products shall be labeled in whose design has been made available accordance with paragraph (c) or (d) of to the public. this section, as appropriate. (4) Renderers shall comply with all (5) Copies of certifications as de- applicable requirements under scribed in paragraphs (d)(2) and (d)(3) of § 589.2001. this section, shall be made available (d) Requirements for protein blenders, for inspection and copying by the Food feed manufacturers, and distributors that and Drug Administration. are not included in paragraph (e) of this (e) Requirements for persons that intend section. (1) Protein blenders, feed manu- to separate mammalian and nonmamma- facturers, and distributors that manu- lian materials. (1) Renderers, protein facture, blend, process, and distribute blenders, feed manufacturers, distribu- products that contain or may contain tors, and others that manufacture, protein derived from mammalian tis- process, blend and distribute both prod- sues shall comply with paragraph (c)(1) ucts that contain or may contain proof this section. tein derived from mammalian tissues (2) Protein blenders, feed manufac- or feeds containing such products, and turers, and distributors, shall be ex- protein products from other animal tis- empt from paragraphs (d)(1) of this sec- sues or feeds containing such products, tion if they: and that intend to keep those products (i) Purchase animal products from separate shall: renderers that certified compliance with paragraph (c)(2) of this section or (i) Comply with paragraphs (c)(1) or purchase such materials from parties (d)(1) of this section as appropriate ex- that certify that the materials were cept that the labeling requirement purchased from renderers that certified shall apply only to products that con- compliance with paragraph (c)(2) of tain or may contain protein derived this section; or from mammalian tissues or feeds con- (ii) Comply with the requirements of taining such products; paragraph (c)(2) of this section where (ii) In the case of a renderer, obtain appropriate. nonmammalian or pure porcine or pure (3) Protein blenders, feed manufac- equine materials only from single-spe- turers, and distributors, shall be ex- cies slaughter facilities; empt from paragraph (c)(1)(ii) of this (iii) Provide for measures to avoid section if they: commingling or cross-contamination;

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(A) Maintain separate equipment or by this section, shall be kept for a min- facilities for the manufacture, proc- imum of 1 year. essing, or blending of such materials; (2) Written procedures required by or this section shall be made available for (B) Use clean-out procedures or other inspection and copying by the Food means adequate to prevent carry-over and Drug Administration. of products that contain or may con- [62 FR 30976, June 5, 1997, as amended at 73 tain protein derived from mammalian FR 22756, Apr. 25, 2008] tissues into animal protein or feeds EFFECTIVE DATE NOTE: At 62 FR 30976, June that may be used for ruminants; and 5, 1997, § 589.2000 was added. Paragraph (iv) Maintain written procedures (e)(1)(iv) of this section contains information specifying the clean-out procedures or collection and recordkeeping requirements other means, and specifying the proce- and will not become effective until approval dures for separating products that con- has been given by the Office of Management and Budget. tain or may contain protein derived from mammalian tissue from all other § 589.2001 Cattle materials prohibited protein products from the time of rein animal food or feed to prevent ceipt until the time of shipment. the transmission of bovine (2) Renderers, blenders, feed manu- spongiform encephalopathy. facturers, and distributors will be ex- (a) Purpose. The purpose of this sec- empted from applicable requirements tion is to prohibit the use of certain of paragraph (e)(1) of this section, if cattle origin materials in the food or they meet the criteria for exemption feed of all animals to further reduce under paragraphs (c)(2) or (c)(3) of this the risk of the spread of bovine section, and (d)(2) or (d)(3) of this sec- spongiform encephalopathy (BSE) tion. within the United States. (3) Renderers shall comply with all (b) Definitions—(1) Cattle materials pro- applicable requirements under hibited in animal feed include: § 589.2001. (i) The entire carcass of BSE-positive (f) Requirements for establishments and cattle; individuals that are responsible for feed- (ii) The brains and spinal cords of ing ruminant animals. Establishments cattle 30 months of age and older; and individuals that are responsible for (iii) The entire carcass of cattle not feeding ruminant animals shall main- inspected and passed for human contain copies of purchase invoices and la- sumption as defined in paragraph (b)(2) of this section that are 30 months of beling for all feeds containing animal age or older from which brains and spi- protein products received, and make nal cords were not effectively removed the copies available for inspection and or otherwise effectively excluded from copying by the Food and Drug Admin- animal feed; istration. (iv) Mechanically separated beef as (g) Adulteration and misbranding. (1) defined in paragraph (b)(3) of this sec- Animal protein products, and feeds tion that is derived from materials containing such products, that are not specified in paragraphs (b)(1)(i), in compliance with paragraphs (c) (b)(1)(ii), and (b)(1)(iii) of this section; through (f) of this section, excluding and labeling requirements, will be deemed (v) Tallow as defined in paragraph adulterated under section 402(a)(2)(C) (b)(5) of this section that is derived or 402(a)(4) of the act. from materials specified in paragraphs (2) Animal protein products, and (b)(1)(i), (b)(1)(ii), and (b)(1)(iii) of this feeds containing such products, that section. are not in compliance with the labeling (vi) Cattle materials prohibited in requirements of paragraphs (c) through animal feed do not include: (f) of this section will be deemed mis- (A) Tallow derivatives as defined in branded under section 403(a)(1) or 403(f) paragraph (b)(6) of this section; of the act. (B) Tallow as defined in paragraph (h) Inspection; records retention. (1) (b)(5) of this section that is derived Records that are to be made available from materials specified in paragraphs for inspection and copying, as required (b)(1)(ii) and (b)(1)(iii) of this section

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and that contains no more than 0.15 processing, or distribute them to firms percent insoluble impurities. Insoluble other than renderers (as defined in this impurities must be measured by the paragraph) whose intended use for the method entitled ‘‘Insoluble Impurities’’ products may include animal feed, in- (AOCS Method Ca 3a–46), American Oil dustrial use, or other uses. The term Chemists’ Society (AOCS), 5th Edition, includes renderers that also blend ani- 1997, incorporated by reference in ac- mal protein products. cordance with 5 U.S.C. 552(a) and 1 CFR (5) Tallow means the rendered fat of part 51, or another method equivalent cattle obtained by pressing or by ap- in accuracy, precision, and sensitivity plying any other extraction process to to AOCS Official Method Ca 3a–46. You tissues derived directly from discrete may obtain copies of the method from adipose tissue masses or to other car- the AOCS (http://www.aocs.org), 2211 W. cass parts and tissues. Bradley Ave., Champaign, IL 61821. (6) Tallow derivative means any prod- Copies may be examined at the Food uct obtained through initial hydrol- and Drug Administration’s Main Li- ysis, saponification, or trans- brary, 10903 New Hampshire Ave., Bldg. esterification of tallow; chemical con- 2, Third Floor, Silver Spring, MD 20993, version of material obtained by hydrol- 301–796–2039, or at the National Ar- ysis, saponification, or trans- chives and Records Administration esterification may be applied to obtain (NARA). For information on the avail- the desired product. ability of this material at NARA, call (c) Requirements. (1) No animal feed or 202–741–6030, or go to: http:// feed ingredient shall be manufactured www.archives.gov/federallregister/ from, processed with, or otherwise con- codeloflfederallregulations/ tain, cattle materials prohibited in ibrllocations.html. animal feed as defined in paragraph (C) Materials as defined in para- (b)(1) of this section. graphs (b)(1)(ii), (b)(1)(iii), (b)(1)(iv) (other than mechanically separated (2) Renderers that receive, manufac- beef from the carcass of a BSE-positive ture, process, blend, or distribute cat- cattle), and (b)(1)(v) of this section tle materials prohibited in animal feed from cattle from a country that has as defined in paragraph (b)(1) of this been designated under paragraph (f) of section, or products that contain or this section. may contain cattle materials prohib- (2) Cattle not inspected and passed for ited in animal feed, shall take the fol- human consumption means cattle that lowing measures to ensure that mate- did not pass antemortem inspection by rials prohibited as defined in paragraph the appropriate regulatory authority. (b)(1) of this section are not introduced This term includes nonambulatory dis- into animal feed: abled cattle. Nonambulatory disabled (i) Exclude from use in animal feed cattle are cattle that cannot rise from the entire carcass of cattle not in- a recumbent position or that cannot spected and passed for human con- walk, including, but not limited to, sumption as defined in paragraph (b)(2) those with broken appendages, severed of this section if: tendons or ligaments, nerve paralysis, (A) The brain and spinal cord are not fractured vertebral column, or meta- effectively removed from such cattle or bolic conditions. the brain and spinal cord from such (3) Mechanically separated beef means cattle are not otherwise effectively ex- a finely comminuted meat food prod- cluded from animal feed; and uct, resulting from the mechanical sep- (B) Such cattle are 30 months of age aration and removal of most of the or older. bone from attached skeletal muscle of (ii) If renderers remove brain and spi- cattle carcasses and parts of carcasses. nal cord from cattle not inspected and (4) Renderer means any firm or indi- passed for human consumption, or sep- vidual that processes slaughter byprod- arate such animals based on whether or ucts, animals unfit for human con- not they are 30 months of age or older, sumption, or meat scraps. The term in- renderers must maintain adequate cludes persons who collect such mate- written procedures specifying how rials and subject them to minimal these processes are carried out.

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(iii) Once cattle materials prohibited (A) Certification or other documenta- in animal feed have been separated tion from the supplier that material from other cattle materials, provide supplied to the renderer does not infor measures to avoid cross-contamina- clude cattle materials prohibited in tion; animal feed; such certification or docu- (A) Use separate equipment while mentation is acceptable, provided that handling cattle materials prohibited in it includes a description of the segrega- animal feed; or tion procedures used, documentation (B) Use separate containers that ade- that the supplier confirms that its seg- quately prevent contact with animal regation procedures are in place prior feed, animal feed ingredients, or equip- to supplying any cattle material to the ment surfaces; renderer, and records of the renderer’s (iv) Label the cattle materials pro- periodic review of the suppliers’ certifi- hibited in animal feed and products cation or other documentation; or that contain or may contain cattle ma- (B) Documentation of another meth- terials prohibited in animal feed in a od acceptable to FDA, such as third- conspicuous manner as follows: ‘‘Do party certification, for verifying that not feed to animals’’; suppliers have effectively excluded cattle materials prohibited in animal feed. (v) Mark the cattle materials prohib- (ii) Comply with all applicable re- ited in animal feed and products that quirements under § 589.2000 regarding contain or may contain cattle mate- animal proteins prohibited in ruminant rials prohibited in animal feed with an feed. agent that can be readily detected on (d) Adulteration and misbranding. (1) visual inspection; and Failure of a renderer to comply with (vi) Establish and maintain records the requirements in paragraphs (c)(2)(i) sufficient to track cattle materials through (c)(2)(iii), (c)(2)(v) and prohibited in animal feed to ensure (c)(2)(vi), or (c)(3)(i) of this section will such material is not introduced into render the animal feed or feed ingredi- animal feed, and make the records ents adulterated under section 402(a)(4) available for inspection and copying by of the Federal Food, Drug, and Cos- the Food and Drug Administration. metic Act (the act). (3) Renderers that receive, manufac- (2) Animal feed or feed ingredients ture, process, blend, or distribute any that are not in compliance with para- cattle materials shall take the fol- graph (c)(1) of this section are adulter- lowing measures to ensure that mate- ated under section 402(a)(2), 402(a)(3), or rials prohibited as defined in paragraph 402(a)(5) of the act. (b)(1) of this section are not used in (3) Animal feed or feed ingredients animal feed: that are not in compliance with the la- (i) Establish and maintain records beling requirements of paragraph sufficient to demonstrate that material (c)(2)(iv) of this section are misbranded rendered for use in animal feed was not under section 403(a)(1) or 403(f) of the manufactured from, processed with, or act. does not otherwise contain, cattle ma- (4) Failure of a renderer to comply terials prohibited in animal feed and with the requirements in paragraph (e) make copies of all records available for of this section will render the animal inspection and copying by the Food feed or feed ingredients adulterated and Drug Administration. With respect under section 402(a)(4) of the act. to cattle materials obtained from es- (e) Inspection; records retention. tablishments which have segregated Records required to be made available cattle materials prohibited in animal for inspection and copying by the Food feed, such records must demonstrate and Drug Administration, as required that establishments supplying cattle by this section, shall be kept for a min- materials to the renderers have ade- imum of 1 year. quate procedures in place to effectively (f) Process for designating countries. A exclude cattle materials prohibited in country seeking designation must send animal feed; and these records shall be a written request to the Director, Of- considered sufficient to meet this re- fice of the Center Director, Center for quirement if they include either: Veterinary Medicine, at the address

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designated in § 5.1100 of this chapter. quest and may impose conditions in The request shall include information granting any such request. Any grant about that country’s BSE case history, by FDA of such a request under this risk factors, measures to prevent the paragraph will be subject to future re- introduction and transmission of BSE, view by FDA and may be revoked if and any other information relevant to FDA determines that the granted re- determining whether the cattle mate- quest is no longer appropriate. rials from the requesting country do or [73 FR 22756, Apr. 25, 2008, as amended at 81 do not meet the definitions set forth in FR 5596, Feb. 3, 2016] paragraph (b)(1) of this section. FDA shall respond in writing to any such re- PARTS 590–599 [RESERVED]

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