Regulatory Information

AMDUCA
Subpart B—Rules and Provisions for Extralabel Uses of Drugs in Animals

Sec. 530.10 Provision Permitting Extralabel Use of Animal Drugs.
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.

Sec. 530.11 Limitations.
In addition to uses which do not comply with the provision set forth in Sec. 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.

Sec. 530.12 Labeling.
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 any other food which might be derived from the treated animal or animals.

Sec. 530.13 Extralabel Use From Compounding of Approved New Animal and Approved Human Drugs.
(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,
  3. 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;
  4. The compounding is performed by a licensed pharmacist or veterinarian
  5. within the scope of a professional practice;
  6. Adequate procedures and processes are followed that ensure the safety and effectiveness of the compounded product;
  7. The scale of the compounding operation is commensurate with the
  8. established need for compounded products (e.g., similar to that of comparable practices); and
  9. All relevant State laws relating to the compounding of drugs for
  10. use in animals are followed.
(c) Guidance on the subject of compounding may be found in guidance documents issued by FDA.