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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2018]
[CITE: 21CFR510]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E--ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
 
PART 510NEW ANIMAL DRUGS
 

Subpart A--General Provisions

Sec. 510.3 Definitions and interpretations.

As used in this part:

(a) The term act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 321-392).

(b) Department means the Department of Health and Human Services.

(c) Secretary means the Secretary of Health and Human Services.

(d) Commissioner means the Commissioner of Food and Drugs.

(e) Person means individuals, partnerships, corporations, and associations.

(f) The definitions and interpretations of terms contained in section 201 of the act shall be applicable to such terms when used in the regulations in this part.

(g) The term new animal drug means any drug intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed:

(1) The composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof; except that such a drug not so recognized shall not be deemed to be a new animal drug if at any time prior to June 25, 1938, it was subject to the Food and Drug Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or

(2) The composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.

(h) The term animal feed means an article which is intended for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal, and is not limited to a mixture intended to be the sole ration of the animal.

(i) The newness of an animal drug, including a new animal drug intended for use in or on animal feed, may arise by reason of: (1) The newness for its intended drug use of any substance of which the drug is comprised, in whole or in part, whether it be an active substance or a menstruum, excipient, carrier, coating, or other component; (2) the newness for its intended drug use of a combination of two or more substances, none of which is itself a new animal drug; (3) the newness for its intended drug use of the proportion of a substance in a combination, even though such combination containing such substance in other proportion is not a new animal drug; (4) the newness for its intended drug use in a different species of animal; (5) the newness of its intended drug use in diagnosing, curing, mitigating, treating, or preventing a disease, or to affect a structure or function of the animal body, even though such drug is not a new animal drug when used in another disease or to affect another structure or function of the body; or (6) the newness of a dosage, or method or duration of administration or application, or any other condition of use prescribed, recommended, or suggested in the labeling of such drug, even though such drug or animal feed containing such drug when used in another dosage, or another method or duration of administration or application, or different condition, is not a new animal drug.

(j) Animals used only for laboratory research and laboratory research animals mean individual animals or groups of animals intended for use and used solely for laboratory research purposes, regardless of species, and does not include animals intended to be used for any food purposes or animals intended to be kept as livestock.

(k) Sponsor means the person requesting designation for a minor-use or minor-species drug as defined in part 516 of this chapter, who must be the real party in interest of the development and the intended or actual production and sales of such drug (in this context, the sponsor may be an individual, partnership, organization, or association). Sponsor also means the person responsible for an investigation of a new animal drug. In this context, the sponsor may be an individual, partnership, corporation, or Government agency or may be a manufacturer, scientific institution, or an investigator regularly and lawfully engaged in the investigation of new animal drugs. Sponsor also means the person submitting or receiving approval for a new animal drug application (in this context, the sponsor may be an individual, partnership, organization, or association). In all contexts, the sponsor is responsible for compliance with applicable provisions of the act and regulations.

[40 FR 13807, Mar. 27, 1975, as amended at 50 FR 7517, Feb. 22, 1985; 54 FR 22741, May 26, 1989; 64 FR 69190, Dec. 10, 1999; 72 FR 41017, July 26, 2007]

Sec. 510.4 Biologics; products subject to license control.

An animal drug produced and distributed in full conformance with the animal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832; 21 U.S.C. 151 et seq. ) and any regulations issued thereunder shall not be deemed to be subject to section 512 of the Federal Food, Drug, and Cosmetic Act.

Sec. 510.7 Consignees of new animal drugs for use in the manufacture of animal feed.

(a) A new animal drug intended for use in the manufacture of animal feed shall be deemed to be unsafe unless at the time of its removal from the establishment of a manufacturer, packer, or distributor of such drug, such manufacturer, packer, or distributor has an unrevoked written statement from the consignee of such drug, or a notice from the Secretary, to the effect that with respect to the use of such drug in animal feed the consignee:

(1) Holds a license issued under 515.20 of this chapter; or

(2) Will, if the consignee is not the user of the drug, ship such drug only to a holder of an approved application under 515.10 of this chapter.

(b) The requirements of paragraph (a) of this section do not apply:

(1) Where such drugs are intended for export and/or

(2) When the use of such drug in the manufacture of a finished feed has been exempted from the requirements of section 512(m) of the act under the conditions specified by regulations published in part 558 of this chapter.

[40 FR 13807, Mar. 27, 1975, as amended at 64 FR 63203, Nov. 19, 1999]

Sec. 510.95 [Reserved]

Subpart B--Specific Administrative Rulings and Decisions

Sec. 510.105 Labeling of drugs for use in milk-producing animals.

(a) Part 526 of this chapter provides for new animal drugs intended for intramammary use in animals and includes conditions of use intended to prevent the contamination of milk from the use of such drugs.

(b) Preparations containing antibiotics and other potent drugs labeled with directions for use in milk-producing animals will be misbranded under section 502(f)(2) of the act unless their labeling bears appropriate warnings and directions for use to avoid adulteration of milk under section 402(a)(2)(c)(ii) of the act.

(c) It is the position of the Food and Drug Administration that the labeling for such preparations should bear a clear warning that either:

(1) The article should not be administered to animals producing milk, since to do so would result in contamination of the milk; or

(2) The label should bear the following statement: "Warning: Milk that has been taken from animals during treatment and for __ hours after the latest treatment must not be used for food", the blank being filled in with the figure that the manufacturer has determined by appropriate investigation is needed to insure that the milk will not carry violative residues resulting from use of the preparation. If the use of the preparation as recommended does not result in contamination of the milk, neither of the above warning statements is required.

[40 FR 13807, Mar. 27, 1975, as amended at 63 FR 32980, June 17, 1998; 64 FR 51241, Sept. 22, 1999]

Sec. 510.106 Labeling of antibiotic and antibiotic-containing drugs intended for use in milk-producing animals.

Whenever the labeling of an antibiotic drug included in the regulations in this chapter suggests or recommends its use in milk-producing animals, the label of such drugs shall bear either the statement "Warning: Not for use in animals producing milk, since this use will result in contamination of the milk" or the statement "Warning: Milk that has been taken from animals during treatment and for __hours after the latest treatment must not be used for food", the blank being filled in with the figure that the Commissioner has authorized the manufacturer of the drug to use. The Commissioner shall determine what such figures shall be from information submitted by the manufacturer and which the Commissioner considers is adequate to prove that period of time after the latest treatment that the milk from treated animals will contain no violative residues from use of the preparation. If the Commissioner determines from the information submitted that the use of the antibiotic drug as recommended does not result in its appearance in the milk, the Commissioner may exempt the drug from bearing either of the above warning statements.

[63 FR 32980, June 17, 1998]

Sec. 510.110 Antibiotics used in food-producing animals.

(a) The Food and Drug Administration in the interest of fulfilling its responsibilities with regard to protection of the public health has requested an evaluation of the public health aspects of the use of antibiotics in veterinary medical and nonmedical uses. There is particular concern with regard to the potential hazards associated with the extensive use of antibiotics administered to food-producing animals. Accordingly, an ad hoc committee on the Veterinary Medical and Nonmedical Uses of Antibiotics was established by the Food and Drug Administration to study and advise the Commissioner of Food and Drugs on the uses of antibiotics in veterinary medicine and for various nonmedical purposes as such uses may affect the enforcement of the Federal Food, Drug, and Cosmetic Act with respect to their safety and effectiveness.

(b) Based upon an evaluation of the conclusions of said Committee and other relevant material, 510.112 was published in the Federal Register of August 23, 1966 (31 FR 11141), asking sponsors of drugs containing any antibiotic intended for use in food-producing animals to submit data to establish whether such antibiotic and its metabolites are present as residues in edible tissues, milk, and eggs from treated animals. The data on the residues of antibiotics in milk from intramammary infusion preparations were requested within 60 days and the data on all other products were requested within 180 days following the date of publication of 510.112 in the Federal Register.

(c) An evaluation of the data now available shows that use of many antibiotic preparations cause residues in edible products of treated animals for varying and, in some cases, for long periods of time following the last administration. Because of the accumulation of new information with regard to the development of resistance of bacteria to antibiotics, the ability of bacteria to transfer this resistance, and the development of sensitivity to antibiotics in humans, unauthorized and unsafe residues of antibiotics cannot be permitted in food obtained from treated animals.

(d) Based on evaluation of information available, including the conclusions of the aforementioned ad hoc Committee, the Commissioner concludes that antibiotic preparations intended for use in food-producing animals, other than topical and ophthalmic preparations, are not generally recognized among qualified experts as having been shown to be safe for their intended use(s) within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act.

(e) Therefore, all exemptions from the provisions of section 409 of the act for use of antibiotics in food-producing animals based on sanctions or approvals granted prior to enactment of the Food Additives Amendment of 1958 (Pub. L. 85-929; 72 Stat. 1784) will be revoked and the uses which are concluded to be safe will be covered by food additive regulations. On those products for which there are inadequate residue data, actions will be initiated to withdraw approval of new-drug applications under the provisions of section 505 of the act. Antibiotic preparations, other than those for topical and ophthalmic application in food-producing animals, which are not covered by food additive regulations will be subject to regulatory action within 180 days after publication of the forthcoming revocation order.

(f) Because of the variation in the period of time that antibiotic residues may remain in edible products from treated animals, all injectable, intramammary infusion, intrauterine, and oral preparations, including medicated premixes intended for use in food-producing animals, are deemed to be new drugs as well as food additives.

[40 FR 13807, Mar. 27, 1975, as amended at 54 FR 18280, Apr. 28, 1989; 64 FR 403, Jan. 5, 1999]

Sec. 510.112 Antibiotics used in veterinary medicine and for nonmedical purposes; required data.

(a) An ad hoc committee, Committee on the Veterinary Medical and Nonmedical Uses of Antibiotics, was formed by the Food and Drug Administration to study, and advise the Commissioner on, the use of antibiotics in veterinary medicine and for various nonmedical purposes as such uses may affect the enforcement of the Federal Food, Drug, and Cosmetic Act with respect to the safety and effectiveness of such substances. A copy of the report may be obtained from the Food and Drug Administration, Office of Public Affairs, Room 15-05, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857.

(b) On the basis of the report of the Committee and other information, sponsors of drugs containing any antibiotic intended for use in food-producing animals shall submit data for determining whether or not such antibiotics and their metabolites are present as residues in edible tissues, milk, and eggs from treated animals; however, in the case of a drug for which such data have already been submitted and for which a regulation has been promulgated under section 409 of the act, only such data as has been accumulated since the issuance of the regulation need be submitted.

(c) The required data shall be submitted within 180 days of the date of publication of this section in the Federal Register; except that in the case of data on intramammary infusion preparations the data shall be submitted within 60 days of such publication. Data demonstrating the absence in milk of residues of intramammary infusion preparations when used as directed in their labeling are needed within the 60-day period because of the importance of milk in the human diet.

(d) Regulatory proceedings including revocation of prior sanctions, or actions to suspend or amend new drug or antibiotic approvals granted prior to passage of the Food Additives Amendment of 1958 (72 Stat. 1784), may be initiated with regard to the continued marketing of any antibiotic preparation on which the required information is not submitted within the period of time prescribed by paragraph (c) of this section.

(e) Questions relating to the acceptability of proposed research protocols and assay methods for determining the amount of antibiotic residues in food should be directed to the Director, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.

[40 FR 13807, Mar. 27, 1975, as amended at 46 FR 8460, Jan. 27, 1981; 54 FR 18280, Apr. 28, 1989; 57 FR 6475, Feb. 25, 1992]

Subpart C [Reserved]

Subpart D--Records and Reports

Sec. 510.301 Records and reports concerning experience with animal feeds bearing or containing new animal drugs for which an approved medicated feed mill license application is in effect.

Records and reports of clinical and other experience with the new animal drug will be maintained and reported, appropriately identified with the new animal drug application(s) or index listing(s) to which they relate, to the Center for Veterinary Medicine in duplicate in accordance with the following:

(a) Immediately upon receipt by the applicant, complete records or reports covering information of the following kinds:

(1) Information concerning any mixup in the new animal drug or its labeling with another article.

(2) Information concerning any bacteriological or any significant chemical, physical, or other change or deterioration in the drug, or any failure of one or more distributed batches of the drug to meet the specifications established for it in the new animal drug application or request for determination of eligibility for indexing.

(b) As soon as possible, and in any event within 15 working days of its receipt by the applicant, complete records or reports concerning any information of the following kinds:

(1) Information concerning any unexpected side effect, injury, toxicity, or sensitivity reaction or any unexpected incidence or severity thereof associated with clinical uses, studies, investigations, or tests, whether or not determined to be attributable to the new animal drug, except that this requirement shall not apply to the submission of information described in a written communication to the applicant from the Food and Drug Administration as types of information that may be submitted at other designated intervals. Unexpected as used in this paragraph refers to conditions or developments not previously submitted as part of the new animal drug application or in support of the index listing or not encountered during clinical trials of the drug, or conditions or developments occurring at a rate higher than shown by information previously submitted as part of the new animal drug application or in support of the index listing or at a rate higher than encountered during such clinical trials.

(2) Information concerning any unusual failure of the new animal drug to exhibit its expected pharmacological activity.

[40 FR 13807, Mar. 27, 1975, as amended at 54 FR 18280, Apr. 28, 1989; 72 FR 69121, Dec. 6, 2007]

Sec. 510.305 Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing new animal drugs.

Each applicant shall maintain in a single accessible location:

(a) A copy of the approved medicated feed mill license (Form FDA 3448) on the premises of the manufacturing establishment; and

(b) Approved or index listed labeling for each Type B and/or Type C feed being manufactured on the premises of the manufacturing establishment or the facility where the feed labels are generated.

[64 FR 63203, Nov. 19, 1999, as amended at 72 FR 69121, Dec. 6, 2007]

Subpart E--Requirements for Specific New Animal Drugs

Sec. 510.410 Corticosteroids for oral, injectable, and ophthalmic use in animals; warnings and labeling requirements.

(a) The Food and Drug Administration has received reports of side effects associated with the oral, injectable, and ophthalmic use of corticosteroid animal drugs. The use of these drugs administered orally or by injection has resulted in premature parturition when administered during the last trimester of pregnancy. Premature parturition may be followed by dystocia, fetal death, retained placenta, and metritis. Additionally, corticosteroids used in dogs, rabbits, and rodents during pregnancy have produced cleft palate in offspring. Use in dogs has resulted in other congenital anomalies, including deformed forelegs, phocomelia, and anasarca. Drugs subject to this section are required to carry the veterinary prescription legend and are subject to the labeling requirements of 201.105 of this chapter.

(b) In view of these potentially serious side effects, the Food and Drug Administration has concluded that the labeling on or within packaged corticosteroid-containing preparations intended for animal use shall bear conspicuously the following warning statement:

Warning: Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

Additionally, corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Corticosteroids administered to dogs during pregnancy have also resulted in other congenital anomalies, including deformed forelegs, phocomelia, and anasarca.

[49 FR 48535, Dec. 13, 1984]

Sec. 510.440 Injectable iron preparations.

There has been an increasing interest in the use of injectable iron compounds for the prevention or treatment of iron-deficiency anemia in animals. Although some such preparations have been shown to be safe, such articles are regarded as new animal drugs within the meaning of the Federal Food, Drug, and Cosmetic Act. Accordingly, an approved new animal drug application is required prior to the marketing of such preparations within the jurisdiction of the act. In addition to the need for demonstrating the safety of such articles, the labeling of such preparations should not only recommend appropriate dosages of iron but also declare the amount (in milligrams) of available iron (Fe) per milliliter of the subject product.

Sec. 510.455 Requirements for free-choice medicated feeds.

(a) What is free-choice medicated feed? For the purpose of this part, free-choice medicated feed is medicated feed that is placed in feeding or grazing areas and is not intended to be consumed fully at a single feeding or to constitute the entire diet of the animal. Free-choice feeds include, but are not limited to, medicated blocks (agglomerated feed compressed or rendered into a solid mass and cohesive enough to hold its form), mineral mixes, and liquid feed tank supplements ("lick tank" supplements) containing one or more new animal drugs. The manufacture of medicated free-choice feeds is subject to the current good manufacturing practice regulations in part 225 of this chapter for medicated feeds.

(b) What is required for new animal drugs intended for use in free-choice feed? Any new animal drug intended for use in free-choice feed must be approved for such use under section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(b)) or listed in the index under section 572 of the act (21 U.S.C. 360ccc-1). Such approvals under section 512 of the act must be:

(1) An original new animal drug application (NADA),

(2) A supplemental NADA, or

(3) An abbreviated NADA.

(c) What are the approval requirements under section 512 of the act for new animal drugs intended for use in free-choice feed? An approval under section 512 of the act for a Type A medicated article intended for use in free-choice feed must contain the following information:

(1) Data, or reference to data in a master file (MF), showing that the target animal consumes the new animal drug in the Type C free-choice feed in an amount that is safe and effective (consumption/effectiveness data); and

(2) Data, or reference to data in an MF, showing the relevant ranges of conditions under which the drug will be chemically and physically stable in the Type C free-choice feed under field conditions.

(d) How are consumption/effectiveness and/or stability data to be submitted? The data must be submitted as follows:

(1) Directly in the NADA, by a sponsor; and/or

(2) To an MF that a sponsor may then reference in its NADA with written consent of the MF holder.

(e) What will be stated in the published approval for a new animal drug intended for use in free-choice feed? The approval of a new animal drug intended for use in free-choice feed, as published in this subchapter, will include:

(1) The formula and/or specifications of the free-choice medicated feed, where the owner of this information requests such publication, or

(2) A statement that the approval has been granted for a proprietary formula and/or specifications.

(f) When is a medicated feed mill license required for the manufacture of a free-choice medicated feed? An approved medicated feed mill license is required for the manufacture of the following types of feeds:

(1) All free-choice medicated feeds that contain a Category II drug, and

(2) Free-choice medicated feeds that contain a Category I drug and use a proprietary formula and/or specifications.

[69 FR 30197, May 27, 2004, as amended at 72 FR 69121, Dec. 6, 2007]

Subpart F [Reserved]

Subpart G--Sponsors of Approved Applications

Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.

(a) Section 512(i) of the act requires publication of names and addresses of sponsors of approved applications for new animal drugs.

(b) In this section each name and address is identified by a numerical drug labeler code. The labeler codes identify the sponsors of the new animal drug applications associated with the regulations published pursuant to section 512(i) of the act. The codes appear in the appropriate regulations and serve as a reference to the names and addresses listed in this section. The drug labeler code is established pursuant to section 510 of the act.

(c) The names, addresses, and drug labeler codes of sponsors of approved new animal drug applications are as follows:

(1) Alphabetical Listing of Sponsors

Firm name and address Drug labeler code
A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., Jackson, NJ 08527057699
Accord Healthcare, Inc., 1009 Slater Rd., suite 210-B, Durham, NC 27703016729
ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115012286
Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503057561
Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112017762
Akorn Animal Health, Inc., 1925 West Field Ct., suite 300, Lake Forest, IL 60045059399
Alaco, Inc., 1500 North Wilmot Rd., suite 290-C, Tucson, AZ 85712064146
Alexion Pharmaceuticals, Inc., 100 College St., New Haven, CT 06510069334
American Pharmaceuticals and Cosmetics, Inc., 1401 Joel East Rd., Fort Worth, TX 76140065531
Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 01801060865
Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043086073
AquaBounty Technologies, Inc., Two Clock Tower Pl., suite 395, Maynard, MA 01754086053
Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS 66211086026
Ark Sciences, Inc., 1101 East 33rd St., suite B304, Baltimore, MD 21218076175
Aurora Pharmaceutical, LLC, 1196 Highway 3 South, Northfield, MN 55057-3009051072
Axcentive SARL, Chemin de Champouse, Quartier Violesi, 13320 Bouc Bel Air, France086009
B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756067188
Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201000859
Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777062250
Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002000010
Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767068330
Ceva Sante Animale, 10 Avenue de la Ballastiere, 33500 Libourne, France013744
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland061651
Cooperative Research Farms, Box 69, Charlotteville, NY 12036051267
Cronus Pharma LLC, 2 Tower Center Blvd., suite 1101, East Brunswick, NJ 08816069043
Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland061623
Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom043264
ECO LLC, 344 Nassau St., Princeton, NJ 08540066916
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140058198
Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013-3928017135
First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123058829
Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 28234015565
Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., Melville, NY 11747025463
G. C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 13201010515
GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702042976
Halocarbon Products Corp., 887 Kinderkamack Rd., River Edge, NJ 07661012164
Happy Jack, Inc., Snow Hill, NC 28580023851
Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., Souderton, PA 18964063075
Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525063604
Hikma International Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118059115
HQ Specialty Pharma Corp., 120 Rte. 17 North, suite 130, Paramus, NJ 07652042791
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria016592
IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd., Greensboro, NC 27409065274
IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544000115
Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940000061
Ivaoes Animal Health, 4300 SW 73rd Ave., suite 110, Miami, FL 33155086064
JBS United Animal Health II LLC, 322 S. Main St., Sheridan, IN 46069051233
Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320, Australia049480
Kinetic Technologies, LLC, 961 Beasley St., suite 270, Lexington, KY 40509051031
LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702086047
Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601061690
Luitpold Pharmaceuticals, Inc., Animal Health Division, Shirley, NY 11967010797
Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861054925
Medicis Dermatologics, Inc., 8125 North Hayden Rd., Scottsdale, AZ 85258099207
Merial, Inc., 3239 Satellite Blvd., bldg. 500, Duluth, GA 30096-4640050604
Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186015914
Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478051079
Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103063286
Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, MS 39120049968
Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511059051
Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland055529
Oasmia Pharmaceutical AB, Vallongatan 1, 75228 Uppsala, Sweden052818
Orion Corp., Orionintie 1, 02200 Espoo, Finland052483
OXIS International, Inc., 6040 N. Cutter Circle, suite 317, Portland, OR 97217-3935024991
Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia068504
Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514055246
Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona, NY 10970050057
Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ 07069042552
Pharmaq AS, Skogmo Industriomrade, N-7863 Overhalla, Norway015331
Pharmgate LLC, 1800 Sir Tyler Dr., Wilmington, NC 28405069254
Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666066104
Piramal Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017066794
Piramal Healthcare Ltd., Piramal Tower, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013, India065085
Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053-120, Campinas, Sao Paulo, Brazil060728
Purina Animal Nutrition LLC, 1080 County Road F West, Shoreview, MN 55126-2910017800
Putney, Inc., One Monument Sq., suite 400, Portland, ME 04101026637
Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349076475
Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001067949
RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620058670
Sergeant's Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138021091
Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215058005
Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151017153
Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503054628
Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752037990
Superior Equine Pharmaceuticals, Inc., Pleasant Grove, UT 84062027053
Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248050378
Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532051672
Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503052923
Thorn Bioscience LLC, 1044 East Chestnut St., Louisville, KY 40204051330
VetDC, Inc., 320 E. Vine Dr., suite 218, Fort Collins, CO 80524086072
Vetoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5059320
Vetoquinol USA, Inc., 4250 N. Sylvania Ave., Fort Worth, TX 76137017030
Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137051311
Walco International, Inc., 15 West Putnam, Porterville, CA 93257049185
Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550053923
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007054771

(2) Numerical Listing of Sponsors

Drug labeler code Firm name and address
000010Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002.
000061Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940.
000115IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544.
000859Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201.
010515G. C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 13201.
010797Luitpold Pharmaceuticals, Inc., Animal Health Division, Shirley, NY 11967.
012164Halocarbon Products Corp., 887 Kinderkamack Rd., River Edge, NJ 07661.
012286ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115.
012578Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.
013744Ceva Sante Animale, 10 Avenue de la Ballastiere, 33500 Libourne, France.
015331Pharmaq AS, Skogmo Industriomrade, N-7863 Overhalla, Norway.
015565Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 28234.
015914Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186.
016592Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria.
016729Accord Healthcare, Inc., 1009 Slater Rd., suite 210-B, Durham, NC 27703.
017030Vetoquinol USA, Inc., 4250 N. Sylvania Ave., Fort Worth, TX 76137.
017135Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013-3928.
017153Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151.
017762Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112.
017800Purina Animal Nutrition, 1080 County Road F West, Shoreview, MN 55126-2910.
021091Sergeant's Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138.
023851Happy Jack, Inc., Snow Hill, NC 28580.
024991OXIS International, Inc., 6040 N. Cutter Circle, suite 317 Portland, OR 97217-3935.
025463Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., Melville, NY 11747.
026637Putney, Inc., One Monument Sq., suite 400, Portland, ME 04101.
027053Superior Equine Pharmaceuticals, Inc., Pleasant Grove, UT 84062.
037990Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752.
042552Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ 07069.
042791HQ Specialty Pharma Corp., 120 Rte. 17 North, suite 130, Paramus, NJ 07652.
042976GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702.
043264Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom.
049185Walco International, Inc., 15 West Putnam, Porterville, CA 93257.
049480Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320, Australia.
049968Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, MS 39120.
050057Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona, NY 10970.
050378Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248.
050604Merial, Inc., 3239 Satellite Blvd., bldg. 500, Duluth, GA 30096-4640.
051031Kinetic Technologies, LLC, 961 Beasley St., suite 270, Lexington, KY 40509.
051072Aurora Pharmaceutical, LLC, 1196 Highway 3 South, Northfield, MN 55057-3009.
051079Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478.
051233JBS United Animal Health II LLC, 322 S. Main St., Sheridan, IN 46069.
051267Cooperative Research Farms, Box 69, Charlotteville, NY 12036.
051311Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137.
051330Thorn Bioscience LLC, 1044 East Chestnut St., Louisville, KY 40204.
051672Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532.
052483Orion Corp., Orionintie 1, 02200 Espoo, Finland.
052818Oasmia Pharmaceutical AB, Vallongatan 1, 75228 Uppsala, Sweden.
052923Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503.
053923Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550.
054628Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503.
054771Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.
054925Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861.
055246Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514.
055529Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland.
057561Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503.
057699A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., Jackson, NJ 08527.
058005Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215.
058198Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.
058670RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620.
058829First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123.
059051Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511.
059115Hikma International Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118.
059320Vetoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5.
059399Akorn Animal Health, Inc., 1925 West Field Ct., suite 300, Lake Forest, IL 60045.
060728Planalquimica Industrial Ltda., Rua das Magnolias nr. Jardim das Bandeiras, CEP 13053-120, Campinas, Sao Alto, Brazil.
060865Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 01801.
061623Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland.
061651Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland.
061690Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601.
062250Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777.
062794Mylan Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478.
063075Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., Souderton, PA 18964.
063286Mylan Institutional, LLC, 4901 Hiawatha Dr., Rockford, IL 61103.
063604Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525.
064146Alaco, Inc., 1500 North Wilmot Rd., suite 290-C, Tucson, AZ 85712.
065085Piramal Healthcare Ltd., Piramal Tower, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013, India.
065274IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd., Greensboro, NC 27409.
065531American Pharmaceuticals and Cosmetics, Inc., 1401 Joel East Rd., Fort Worth, TX 76140.
066104Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666.
066794Piramal Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017.
066916ECO LLC, 344 Nassau St., Princeton, NJ 08540.
067188B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756.
067949Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001.
068330Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767.
068504Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia.
069043Cronus Pharma LLC, 2 Tower Center Blvd., suite 1101, East Brunswick, NJ 08816.
069254Pharmgate LLC, 1800 Sir Tyler Dr., Wilmington, NC 28405.
069334Alexion Pharmaceuticals, Inc., 100 College St., New Haven, CT 06510.
076175Ark Sciences, Inc., 1101 East 33rd St., suite B304, Baltimore, MD 21218.
076475Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349.
086009Axcentive SARL, Chemin de Champouse, Quartier Violesi, 13320 Bouc Bel Air, France.
086026Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS 66211.
086047LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702.
086053AquaBounty Technologies, Inc., Two Clock Tower Pl., suite 395, Maynard, MA 01754.
086064Ivaoes Animal Health, 4300 SW 73rd Ave., suite 110, Miami, FL 33155.
086072VetDC, Inc., 320 E Vine Dr., suite 218, Fort Collins, CO 80524.
086073Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043.
099207Medicis Dermatologics, Inc., 8125 North Hayden Rd., Scottsdale, AZ 85258.

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.

[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.fdsys.gov.

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
Source: 40 FR 13807, Mar. 27, 1975, unless otherwise noted.

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