Regulatory Information

AMDUCA
Subpart C—Specific Provisions Relating to Extralabel Use of Animal and Human Drugs in Food-Producing Animals

Sec. 530.1 Scope.
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.

Sec. 530.20 Conditions For Permitted Extralabel Animal and Human Drug Use in Food-Producing Animals.
(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
  2. 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.
  3. Prior to prescribing or dispensing an approved new animal or human drug
  4. 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 mink, 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 subjected to extralabel treatment.
(b) The following additional conditions must be met for a permitted extralabel use of in food-producing animals an approved human drug, or of an animal drug approved only for use in animals not intended for human consumption:
  1. Such use must be accomplished in accordance with an appropriate medical
  2. rationale; and
  3. If scientific information on the human food safety aspect of the use of the
  4. drug in food-producing animals is not available, the veterinarian must take appropriate measures to assure that the animal and its food products will not enter the human food supply.
(c) Extralabel use of an approved human drug in a food-producing animal is not permitted under this part if an animal drug approved for use in food-producing animals can be used in an extralabel manner for the particular use.

Sec. 530.21 Prohibitions For Food-Producing Animals.
(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
  2. has not been established or cannot be established; or
  3. The extralabel use of the drug or class of drugs presents a risk to the
  4. 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.

Sec. 530.22 Safe Levels and Analytical Methods for Food-Producing Animals.
(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
  2. from available sources;
  3. Establish a safe level based on the lowest level that can be measured by
  4. a practical analytical method; or
  5. Establish a safe level based on other appropriate scientific, technical, or regulatory criteria.

(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 Federal Register.
(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 approval for that particular species or category of animals, for that species or category of animals, the safe level is superseded by the tolerance or safe concentration for that species or category of animals.

Sec. 530.23 Procedure For Setting and Announcing Safe Levels.
(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 Federal Register a notice of the order. The notice will include:

  1. A statement setting forth the agency’s finding that there is a
  2. reasonable probability that extralabel use in animals of the human drug or animal drug may present a risk to the public health;
  3. A statement of the basis for that finding; and

  4. 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 Sec. 530.40.

Sec. 530.24 Procedure For Announcing Analytical Methods For Drug Residue Qantification.
(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 Sec. 530.22 for extralabel use of an approved human drug or an approved animal drug. The agency will publish in the Federal Register 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 Sec. 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 Sec. 530.22 is developed, and that method is acceptable to the agency, FDA will incorporate that method by reference.

Sec. 530.25 Orders Prohibiting Extralabel Uses for Drugs in Food-Producing Animals.
(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 Sec. 530.22 has not
  2. been developed, submitted, and found to be acceptable by FDA or that such method cannot be established; or
  3. The extralabel use in animals presents a risk to the public health.

(b) After making a determination that the analytical method required under Sec. 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 Federal Register, 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 Sec. 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 and extent of the order of prohibition and the reasons
  2. for the prohibition;
  3. Request public comments; and
  4. Provide a period of not less than 60 days for comments.

(c) The order of prohibition will become effective 90 days after date of publication of the order unless FDA publishes a notice in the Federal Register prior to that date, that revokes the order of prohibition, modifies it, or extends the period of public comment.
(d) The agency may publish an order of prohibition with a shorter comment period and/or delayed effective date than specified in paragraph (b) of this section in exceptional circumstances (e.g., where there is immediate risk to the public health), provided that the order of prohibition states that the comment period and/or effective date have been abbreviated because there are exceptional circumstances and the order of prohibition sets forth the agency’s rationale for taking such action.
(e) If FDA publishes a notice in the Federal Register modifying an order of prohibition, the agency will specify in the modified order of prohibition the nature and extent of the modified prohibition, the reasons for it, and the agency’s response to any comments on the original order of prohibition.
(f) A current listing of drugs prohibited for extralabel use in animals will be codified in Sec. 530.41.
(g) After the submission of appropriate information (i.e., adequate data, an acceptable method, approval of a new animal drug application for the prohibited extralabel use, or information demonstrating that the prohibition was based on incorrect data), FDA may, by publication of an appropriate notice in the Federal Register, remove a drug from the list of human and animal drugs prohibited for extralabel use in animals, or may modify a prohibition.
(h) FDA may prohibit extralabel use of a drug in food-producing animals without establishing a safe level.