Subpart G-Sponsors of Approved 510.600 Names, addresses, and drug labeler AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. SOURCE: 40 FR 13807, Mar. 27, 1975, unless otherwise noted. Subpart A-General Provisions §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 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 (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 to be kept as livestock. (k) The term sponsor means the person responsible for an investigation of a new animal drug, including responsibility for compliance with applicable provisions of the act and regulations. 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. (1) Designated journal(s) means journals listed in § 510.95. [40 FR 13807, Mar. 27, 1975, as amended at 50 FR 7517, Feb. 22, 1985; 54 FR 22741, May 26, 1989] EFFECTIVE DATE NOTE: At 64 FR 69190, Dec. 10, 1999 §510.3 was amended by removing paragraph (1), effective Apr. 24, 2000. §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. 8510.7 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] 8510.95 Designated journals. The following journals are available to the Food and Drug Administration and thus permit waiving of the submission of reprints and summaries covering reports contained in these journals to the extent that such requirements are waived in the regulations in this part: All Pet's Magazine (Jersey City). American Journal of Veterinary Research (Chicago). Animal Health (Journal of the Animal Animal Nutrition & Health (Sausalito, CA). British Poultry Science (Edinburgh). Canadian Journal of Comparative Medicine and Veterinary Science (Gardenvale, Quebec). Canadian Veterinary Journal (Guelph, Ontario). Cornell Veterinarian (Ithaca). Experimental Parasitology (New York). Hoard's Dairyman (Fort Atkinson). Journal of the American Veterinary Medical Journal of Animal Science (Albany). Journal of Small Animal Practice (London). Poultry Science (Guelph, Ontario). Veterinarian (International) (New York). Veterinary Medicine (Kansas City, MO). [40 FR 13807, Mar. 27, 1975, as amended at 50 FR 7517, Feb. 22, 1985] EFFECTIVE DATE NOTE: At 64 FR 69190, Dec. 10, 1999 §510.95 was removed and reserved, effective Apr. 24, 2000. Subpart B-Specific Administrative Rulings and Decisions 8510.105 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] §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] 8510.110 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 cludes 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. con (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 conIcluded 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 newdrug 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] 8510.112 Antibiotics used in veteri nary 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 8510.300 Records and reports concerning experience with new animal drugs for which an approved application is in effect. (a) On receiving notification that an application submitted pursuant to § 514.1 of this chapter for a new animal drug is approved, the applicant shall establish and maintain such records and make such reports as are specified in this section to facilitate a determination as to whether there may be grounds for suspending or withdrawing approval of the application or whether any applicable regulation should be amended or repealed. The applicant shall maintain adequately organized and indexed files containing full reports of information pertinent to the safety or effectiveness of the new animal drug that have not previously been submitted as part of his application for the drug and which are received or oth erwise obtained by him from any source, as follows: (1) Unpublished reports of clinical or other animal experience, studies, investigations, and tests conducted by the applicant or reported to him by any person involving the new animal drug that is the subject of the application or any related drugs. An adequate summary and bibliography of reports in the scientific literature would ordinarily suffice. (The application must identify at the time of each report submission, each drug he considers related to the subject drug.) (2) Experience, investigations, studies, or tests involving the chemical or physical properties or any other properties of the new animal drug, such as its behavior or properties in relation to microorganisms, including both the effects of the drug on microorganisms and the effect of microorganisms on the drug. (3) For information required by this section, adequate identification of its source, when known, including the name and post office address of the person who furnishes such information. (4) Copies of all mailing pieces and other labeling, and, if it is a prescription new animal drug, all advertising other than that contained in the application used in promoting the drug, and copies of the currently used package labeling that gives full information for use of the drug whether or not such labeling is contained in the application. (5) Information concerning the quantity of the new animal drug distributed in a manner and form that facilitates estimates of the incidence of any adverse effects reported to be associated with the use of the drug. This does not require disclosure of financial, pricing, or sales data. (6) Information concerning any previously unreported changes from the conditions described in an application conforming to the conditions § 514.8(a)(5) of this chapter. of (b) The applicant shall submit to the Food and Drug Administration copies of the records and reports described in paragraph (a) of this section, except routine assay and control records, appropriately identified with the new animal drug application(s) to which they relate, as follows: |