Title 21 CFR reference

This part applies to the extralabel use in an animal of any approved new animal drug or approved new human drug by or on the lawful order of a licensed veterinarian within the context of a valid veterinary-client-patient relationship.

An approved new animal drug or human drug intended to be used for an extralabel purpose in an animal is not unsafe under section 512 of the act and is exempt from the labeling requirements of section 502(f) of the act if such use is: (a) By or on the lawful written or oral order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship; and (b) In compliance with this part.

In addition to uses which do not comply with the provision set forth in § 530.10, the following specific extralabel uses are not permitted and result in the drug being deemed unsafe within the meaning of section 512 of the act: (a) Extralabel use in an animal of an approved new animal drug or human drug by a lay person (except when under the supervision of a licensed veterinarian); (b) Extralabel use of an approved new animal drug or human drug in or on an animal feed; (c) Extralabel use resulting in any residue which may present a risk to the public health; and (d) Extralabel use resulting in any residue above an established safe level, safe concentration or tolerance.

Any human or animal drug prescribed and dispensed for extralabel use by a veterinarian or dispensed by a pharmacist on the order of a veterinarian shall bear or be accompanied by labeling information adequate to assure the safe and proper use of the product. Such information shall include the following: (a) The name and address of the prescribing veterinarian. If the drug is dispensed by a pharmacy on the order of a veterinarian, the labeling shall include the name of the prescribing veterinarian and the name and address of the dispensing pharmacy, and may include the address of the prescribing veterinarian; (b) The established name of the drug or, if formulated from more than one active ingredient, the established name of each ingredient; (c) Any directions for use specified by the veterinarian, including the class/species or identification of the animal or herd, flock, pen, lot, or other group of animals being treated, in which the drug is intended to be used; the dosage, frequency, and route of administration; and the duration of therapy; (d) Any cautionary statements; and (e) The veterinarian's specified withdrawal, withholding, or discard time for meat, milk, eggs, or…

(a) This part applies to compounding of a product from approved animal or human drugs by a veterinarian or a pharmacist on the order of a veterinarian within the practice of veterinary medicine. Nothing in this part shall be construed as permitting compounding from bulk drugs. (b) Extralabel use from compounding of approved new animal or human drugs is permitted if: (1) All relevant portions of this part have been complied with; (2) There is no approved new animal or approved new human drug that, when used as labeled or in conformity with criteria established in this part, will, in the available dosage form and concentration, appropriately treat the condition diagnosed. Compounding from a human drug for use in food-producing animals will not be permitted if an approved animal drug can be used for the compounding; (3) The compounding is performed by a licensed pharmacist or veterinarian within the scope of a professional practice; (4) Adequate procedures and processes are followed that ensure the safety and effectiveness of the compounded product; (5) The scale of the compounding operation is commensurate with the established need for compounded products (e.g., similar to…

The purpose of this part is to establish conditions for extralabel use or intended extralabel use in animals by or on the lawful order of licensed veterinarians of Food and Drug Administration approved new animal drugs and approved new human drugs. Such use is limited to treatment modalities when the health of an animal is threatened or suffering or death may result from failure to treat. This section implements the Animal Medicinal Drug Use Clarification Act of 1994 (the AMDUCA) (Pub. L. 103-396).

(a) The following conditions must be met for a permitted extralabel use in food-producing animals of approved new animal and human drugs: (1) There is no approved new animal drug that is labeled for such use and that contains the same active ingredient which is in the required dosage form and concentration, except where a veterinarian finds, within the context of a valid veterinarian-client-patient relationship, that the approved new animal drug is clinically ineffective for its intended use. (2) Prior to prescribing or dispensing an approved new animal or human drug for an extralabel use in food animals, the veterinarian must: (i) Make a careful diagnosis and evaluation of the conditions for which the drug is to be used; (ii) Establish a substantially extended withdrawal period prior to marketing of milk, meat, eggs, or other edible products supported by appropriate scientific information, if applicable; (iii) Institute procedures to assure that the identity of the treated animal or animals is carefully maintained; and (iv) Take appropriate measures to assure that assigned timeframes for withdrawal are met and no illegal drug residues occur in any food-producing animal…

(a) FDA may prohibit the extralabel use of an approved new animal or human drug or class of drugs in food-producing animals if FDA determines that: (1) An acceptable analytical method needs to be established and such method has not been established or cannot be established; or (2) The extralabel use of the drug or class of drugs presents a risk to the public health. (b) A prohibition may be a general ban on the extralabel use of the drug or class of drugs or may be limited to a specific species, indication, dosage form, route of administration, or combination of factors.

(a) FDA may establish a safe level for extralabel use of an approved human drug or an approved new animal drug when the agency finds that there is a reasonable probability that an extralabel use may present a risk to the public health. FDA may: (1) Establish a finite safe level based on residue and metabolism information from available sources; (2) Establish a safe level based on the lowest level that can be measured by a practical analytical method; or (3) Establish a safe level based on other appropriate scientific, technical, or regulatory criteria. Federal Register.04(b) FDA may require the development of an acceptable analytical method for the quantification of residues above any safe level established under this part. If FDA requires the development of such an acceptable analytical method, the agency will publish notice of that requirement in the (c) The extralabel use of an animal drug or human drug that results in residues exceeding a safe level established under this part is an unsafe use of such drug. (d) If the agency establishes a safe level for a particular species or category of animals and a tolerance or safe concentration is later established through an…

Federal Register04(a) FDA may issue an order establishing a safe level for a residue of an extralabel use of an approved human drug or an approved animal drug. The agency will publish in the a notice of the order. The notice will include: (1) A statement setting forth the agency's finding that there is a reasonable probability that extralabel use in animals of the human drug or animal drug may present a risk to the public health; (2) A statement of the basis for that finding; and (3) A request for public comments. (b) A current listing of those drugs for which a safe level for extralabel drug use in food-producing animals has been established, the specific safe levels, and the availability, if any, of a specific analytical method or methods for drug residue detection will be codified in § 530.40.

Federal Register04(a) FDA may issue an order announcing a specific analytical method or methods for the quantification of extralabel use drug residues above the safe levels established under § 530.22 for extralabel use of an approved human drug or an approved animal drug. The agency will publish in the a notice of the order, including the name of the specific analytical method or methods and the drug or drugs for which the method is applicable. (b) Copies of analytical methods for the quantification of extralabel use drug residues above the safe levels established under § 530.22 will be available upon request from the Communications and Education Branch (HFV-12), Division of Program Communication and Administrative Management, Center for Veterinary Medicine, 7500 Standish Pl., Rockville, MD 20855. When an analytical method for the detection of extralabel use drug residues above the safe levels established under § 530.22 is developed, and that method is acceptable to the agency, FDA will incorporate that method by reference.

(a) FDA may issue an order prohibiting extralabel use of an approved new animal or human drug in food-producing animals if the agency finds, after providing an opportunity for public comment, that: (1) An acceptable analytical method required under § 530.22 has not been developed, submitted, and found to be acceptable by FDA or that such method cannot be established; or (2) The extralabel use in animals presents a risk to the public health. Federal Register,04(b) After making a determination that the analytical method required under § 530.22 has not been developed and submitted, or that such method cannot be established, or that an extralabel use in animals of a particular human drug or animal drug presents a risk to the public health, FDA will publish in the with a 90-day delayed effective date, an order of prohibition for an extralabel use of a drug in food-producing animals. Such order shall state that an acceptable analytical method required under § 530.22 has not been developed, submitted, and found to be acceptable by FDA; that such method cannot be established; or that the extralabel use in animals presents a risk to the public health; and shall: (1) Specify the nature…

Extralabel use(a) 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 dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from the labeled withdrawal time based on these different uses. FDA(b) means the U.S. Food and Drug Administration. a reasonable probability that a drug's use may present a risk to the public health(c) The phrase means that FDA has reason to believe that use of a drug may be likely to cause a potential adverse event. use of a drug may present a risk to the public health(d) The phrase means that FDA has information that indicates that use of a drug may cause an adverse event. use of a drug presents a risk to the public health(e) The phrase means that FDA has evidence that demonstrates that the use of a drug has caused or likely will cause an adverse event. residue(f) A means any compound present in edible tissues that results from the use of a drug, and includes the…

(a) Because extralabel use of animal and human drugs in nonfood-producing animals does not ordinarily pose a threat to the public health, extralabel use of animal and human drugs is permitted in nonfood-producing animal practice except when the public health is threatened. In addition, the provisions of § 530.20(a)(1) will apply to the use of an approved animal drug. Federal Register04(b) If FDA determines that an extralabel drug use in animals not intended for human consumption presents a risk to the public health, the agency may publish in the a notice prohibiting such use following the procedures in § 530.25. The prohibited extralabel drug use will be codified in § 530.41.

Nothing in this part shall be construed as permitting the advertising or promotion of extralabel uses in animals of approved new animal drugs or approved human drugs.

(a) In accordance with § 530.22, the following safe levels for extralabel use of an approved animal drug or human drug have been established: [Reserved] (b) In accordance with § 530.22, the following analytical methods have been accepted by FDA: [Reserved]

(a) The following drugs, families of drugs, and substances are prohibited for extralabel animal and human drug uses in food-producing animals. (1) Chloramphenicol; (2) Clenbuterol; (3) Diethylstilbestrol (DES); (4) Dimetridazole; (5) Ipronidazole; (6) Other nitroimidazoles; (7) Furazolidone. (8) Nitrofurazone. (9) Sulfonamide drugs in lactating dairy cattle (except approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine); (10) Fluoroquinolones; and (11) Glycopeptides. (12) Phenylbutazone in female dairy cattle 20 months of age or older. (13) Cephalosporins (not including cephapirin) in cattle, swine, chickens, or turkeys: (i) For disease prevention purposes; (ii) At unapproved doses, frequencies, durations, or routes of administration; or (iii) If the drug is not approved for that species and production class. (b) The following drugs, families of drugs, and substances are prohibited for extralabel animal and human drug uses in nonfood-producing animals: [Reserved] (c) [Reserved] (d) The following drugs, or classes of drugs, that are approved for treating or preventing influenza A, are prohibited from extralabel use in chickens, turkeys,…

(a) As a condition of extralabel use permitted under this part, to permit FDA to ascertain any extralabel use or intended extralabel use of drugs that the agency has determined may present a risk to the public health, veterinarians shall maintain the following records of extralabel uses. Such records shall be legible, documented in an accurate and timely manner, and be readily accessible to permit prompt retrieval of information. Such records shall be adequate to substantiate the identification of the animals and shall be maintained either as individual records or, in food animal practices, on a group, herd, flock, or per-client basis. Records shall be adequate to provide the following information: (1) The established name of the drug and its active ingredient, or if formulated from more than one ingredient, the established name of each ingredient; (2) The condition treated; (3) The species of the treated animal(s); (4) The dosage administered; (5) The duration of treatment; (6) The numbers of animals treated; and (7) The specified withdrawal, withholding, or discard time(s), if applicable, for meat, milk, eggs, or any food which might be derived from any food animals…