Bulk Drug Substances Currently Under Review
List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals
Bulk Drug Substances Reviewed and Not Listed
These bulk drug substances are currently being evaluated by FDA. While these evaluations are being completed, the agency generally intends to refrain from taking enforcement action when these bulk drug substances are used to compound a finished drug in a state-licensed pharmacy or federal facility or by a state-licensed veterinarian as described in the initial nomination.
Once the evaluation for a given bulk drug substance has been fully completed, those found to meet criteria for inclusion on a list will be removed from the “Currently Under Review” status and will be added to the appropriate list for nonfood-producing animals, food-producing animals, or free-ranging wildlife species. Those bulk drug substances that are not found to meet criteria for inclusion on a list will be designated as “Bulk Drug Substances Reviewed and Not Listed.”
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.
DOGS, CATS, HORSES
- Awaiting additional nominations
NONFOOD-PRODUCING MINOR SPECIES
- Atipamezole HCl (Nonfood-producing minor species)
- Indication: For the reversal of the effects of medetomidine in zoo animals and captive wildlife species when a high concentration of atipamezole hydrochloride is required.
- Dosage form: 25 mg/mL injectable solution.
- Azaperone tartrate (Nonfood-producing minor species)
- Indication: For immobilization and anesthesia of zoo animals and captive wildlife species.
- Dosage form: 10 mg/mL injectable solution.
FOOD-PRODUCING ANIMALS OR FREE-RANGING WILDLIFE SPECIES
- Atipamezole HCl (Free-ranging wildlife)
- Indication: For the reversal of the effects of medetomidine in free-ranging wildlife species when a high concentration of atipamezole hydrochloride is required.
- Dosage form: 25 mg/mL injectable solution.
- Azaperone tartrate (Free-ranging wildlife)
- Indication: For immobilization and anesthesia of free-ranging wildlife species.
- Dosage form: 10 mg/mL injectable solution.