AMDUCA regulates small and large animal practice

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By Dean J. Monti
Dr. Elizabeth Curry-Galvin, assistant director of the AVMA Scientific Activities Division, contributed to this article.

IggyIggy had an abscess. After a thorough checkup and diagnosis by a small animal practitioner, the green iguana was treated and given antibiotics.

SportyMr. Peters, a cockatiel, had internal parasites and was treated with an anthelmintic. Dirk, a Cocker Spaniel, had an advanced case of lymphoma. A large part of his treatment was the administration of chemotherapeutics. Sporty, an epileptic Dachshund, was being given an anticonvulsant. It was also time to adjust the insulin dosage being given to Mitzi, the Persian cat, for her diabetes.

These examples describe some of the pharmacologicals used in a typical day in a small animal practice. The common thread in this fictitious scenario is that Iggy, Mr. Peters, Dirk, Sporty, and Mitzi were all treated with the extralabel use of drugs.

Extralabel drug usage may not always be foremost on a veterinarian's mind. It should be. Often thought of as a topic pertaining to large animals, extralabel drug use is a pertinent subject to all practitioners.

Records & Labels
Records on extralabel drug use must include:
- Animal's identification and species
- Number of animals treated (eg, if used in a kennel, cattery, or aviary)
- Condition being treated
- Drug name and active ingredient
- Drug dosage and duration of treatment
- Withdrawal time, for food animals

Labels on the medication must have:
- Name and address of prescribing veterinarian
- The animal's identification
- Drug name
- Directions for use
- Dosage
- Route of administration
- Duration of treatment
- Any precautionary statements
- Withdrawal time for food animals
(State practice acts may require additional labeling information, such as the date dispensed, strength of medication, and the quantity dispensed.)

The enactment of the Animal Medicinal Drug Use Clarification Act (AMDUCA), whose provisions became effective Dec 9, 1996, means that veterinarians now have the ability, recognized by law, to use drugs in an extralabel manner in their practices. AMDUCA amended the federal Food, Drug & Cosmetic Act to permit veterinarians to prescribe extralabel uses of approved human and animal drugs for their patients in compliance with FDA regulations. The law imposes certain restrictions on veterinarians who prescribe extralabel uses of approved human and animal drugs, but most of these restrictions apply to use in food-producing animals.

It would be a mistake, however, not to consider extralabel use as it affects small animals. In addition to the aforementioned drugs, others that might be used in small animal practice and may involve extralabel use include pre-anesthetic drugs, antihistamines, and behavioral drugs. No drugs are prohibited for extralabel use in companion animals as they are for food animals.

AMDUCA requires veterinarians to keep good records for any extralabel drug use for two years. Individual state practice acts may require longer periods, so veterinarians should make sure they are in compliance with their state practice act.

Tending to the needs of an iguana may not be an everyday occurrence. Applying and adhering to the rules of AMDUCA, however, should be a concern of every veterinarian, from their first patient to their last.

Extralabel Use in Nonfood Animals

  • Extralabel drug use is permitted only by or under the supervision of a veterinarian.
  • A veterinarian-client-patient relationship is a prerequisite for all extralabel drug use.
  • Unless the public health is threatened, veterinarians may use approved animal and human drugs for therapeutic purposes in an extralabel manner.
  • An approved human drug may be used in an extralabel manner even when an identical, approved animal drug is available.
  • An animal drug may be used in an extralabel manner only if no approved animal drug containing the active ingredient needed is available in the required dosage form labeled for the indication.
  • If there is an approved animal drug available in the required dosage form labeled for the indication but it is judged clinically ineffective for that use, the veterinarian may use that drug or another animal drug in an extralabel manner.