Regulatory Information

AMDUCA
Subpart A—General Provisions

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. 530.2 Purpose.
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).

Sec. 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 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.
(b) FDA means the U.S. Food and Drug Administration.
(c) The phrase a reasonable probability that a drug’s use may present a risk to the public health means that FDA has reason to believe that use of a drug may be likely to cause a potential adverse event.
(d) The phrase use of a drug may present a risk to the public health means that FDA has information that indicates that use of a drug may cause an adverse event.
(e) The phrase use of a drug presents a risk to the public health means that FDA has evidence that demonstrates that the use of a drug has caused or likely will cause an adverse event.
(f) A residue means any compound present in edible tissues that results from the use of a drug, and includes the drug, its metabolites, and any other substance formed in or on food because of the drug’s use.
(g) A safe level is a conservative estimate of a drug residue level in edible animal tissue derived from food safety data or other scientific information. Concentrations of residues in tissue below the safe level will not raise human food safety concerns. A safe level is not a safe concentration or a tolerance and does not indicate that an approval exists for the drug in that species or category of animal from which the food is derived.
(h) Veterinarian means a person licensed by a State or Territory to practice veterinary medicine.
(i) A valid veterinarian-client-patient relationship is one in which:

  1. A veterinarian has assumed the responsibility
    2. for making medical judgments regarding the health of (an) animal(s) and the need for medical treatment, and the client (the owner of the animal or animals or other caretaker) has agreed to follow the instructions of the veterinarian;
  2. There is sufficient knowledge of the animal(s) by the veterinarian
    3. to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s); and
  3. The practicing veterinarian is readily
    4. available for followup in case of adverse reactions or failure of the regimen of therapy. Such a relationship can exist only when the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of examination of the animal(s), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.

Sec. 530.4 Advertising and promotion.
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.

Sec. 530.5 Veterinary records.
(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
    2. 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
    8. or discard time(s), if applicable, for meat, milk, eggs, or any food which might be derived from any food animals treated.
(b) A veterinarian shall keep all required records for 2 years or as otherwise required by Federal or State law, whichever is greater.
(c) Any person who is in charge, control, or custody of such records shall, upon request of a person designated by FDA, permit such person designated by FDA to, at all reasonable times, have access to, permit copying, and verify such records.