List of Bulk Drug Substances for Compounding Drugs for Use in Food-Producing Animals or Free-Ranging Wildlife Species

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.

We remind veterinarians to consider hunting season before administering sedatives and anesthetics to free-ranging wildlife that cannot be confined for the drug’s withdrawal time and to avoid using these drugs in animals that may be harvested in the near future, if possible. 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-xxxx. [phone number of veterinarian or animal health professional].’

FOOD-PRODUCING ANIMALS (ANTIDOTES)

Bulk Drug Substance (BDS)	Species	Dosage form(s)	Strength/concentration	Reasons
Copper glycinate (1/31/2022)	beef calves and beef cattle	Injection	200 mg/ml	Injectable copper glycinate is needed for use as an antidote in cattle. There are no FDA-approved injectable drug products containing copper glycinate.

FREE-RANGING WILDLIFE SPECIES (SEDATIVES AND ANESTHETICS

Bulk Drug Substance (BDS)	Species	Dosage form(s)	Strength/concentration	Reasons
Alpha-chloralose (1/9/2024)	Sandhill Cranes Canada Geese, American Coots, Mallards	Powder for oral administration via hand baiting	Up to 50mg/kg bodyweight per dose Up to 30 mg/kg bodyweight per dose	Alpha-chloralose is needed for sedation of these wild birds. There are no FDA-approved or indexed drugs that contain alpha-chloralose. There are FDA-approved anesthetic and sedative drugs that could be used in an extralabel manner under 21 CFR Part 230, but according to scientific experts, alpha-chloralose oral powder is an optimal dosage form for use in these wild birds.
Azaperone tartrate (2/1/2022)	free-ranging wildlife species	suspension for injection	40 mg/ml	Azaperone tartrate is needed for use in the tranquilization and sedation of free-ranging wildlife species. There is no FDA-approved or indexed azaperone product currently marketed.
Diprenorphine (2/1/2022)	free-ranging wildlife species	solution for injection	2 mg/ml	Diprenorphine is needed for reversing the effects of etorphine in free-ranging wildlife species. There is no FDA-approved or indexed diprenorphine product currently marketed.
Etorphine hydrochloride (2/1/2022)	free-ranging wildlife species	solution for injection	10 mg/ml	Etorphine hydrochloride is needed for use in the immobilization and anesthesia of free-ranging wildlife species. There is no FDA-approved or indexed etorphine product currently marketed.
Ketamine hydrochloride (3/8/2022)	free-ranging wildlife species	solution for injection	200 mg/ml	Ketamine in a highly concentrated injectable formulation is needed for the immobilization and anesthesia of free-ranging wildlife species. There is no FDA-approved or indexed ketamine product in this concentration currently marketed.
Medetomidine hydrochloride (2/1/2022)	free-ranging wildlife species	solution for injection	10, 20, 40 mg/ml	Medetomidine in these concentrations is needed for the immobilization, anesthesia, sedation, and analgesia of free-ranging wildlife species. FDA-approved medetomidine for use in animals is no longer marketed.