List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals

Bulk Drug Substances Currently Under Review

Bulk Drug Substances Reviewed and Not Listed

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These bulk drug substances were determined to meet the criteria for inclusion on the List of Bulk Drug Substances for Compounding Drugs for Use in Food-Producing Animals or Free-Ranging Wildlife Species. FDA does not generally intend to take enforcement action against a state-licensed pharmacy or state-licensed veterinarian using these bulk drug substances to compound the below drug preparations for the corresponding species and disease indications, as described in Guidance for Industry #256 Compounding Animal Drugs from Bulk Drug Substances.

FDA will accept nominations of additional bulk drug substances at any time and will continue to review nominations and update lists. For information on how to submit a bulk drug substance nomination, see the appendix to Guidance for Industry #256 Compounding Animal Drugs from Bulk Drug Substances.

When using these drugs, we expect the prescribing veterinarian, acting within a valid veterinarian-client-patient relationship (VCPR), to establish scientifically-based withdrawal, withholding, and discard times to ensure that animals treated with these drugs do not contain residues of the antidote, sedative, or anesthetic, or alternatively, to ensure that the treated animals do not enter the food supply. 

Sedatives and anesthetics administered to free-ranging wildlife species should not be used within 30 days of hunting season. If this is not feasible due to an emergency situation, any animal administered a sedative or anesthetic alone or in combination with other drugs should be tagged with an ear tag that has the following language: ‘DO NOT CONSUME if harvested before MM-DD-YYY. Call xxx-xxx-xxx.’ The tag should include a date that is at least 30 days after the date of administration of the drug and the phone number of the veterinarian or person in charge.

FOOD-PRODUCING ANIMALS (ANTIDOTES)

FREE-RANGING WILDLIFE SPECIES (SEDATIVES AND ANESTHETICS