On November 20, 2019, FDA issued Draft GFI #256, Compounding Animal Drugs from Bulk Drug Substances. When finalized, this guidance will describe the circumstances in which FDA does not intend to take action against drugs compounded from bulk drug substances. FDA is developing a list of bulk drugs substances for use, when draft GFI #256 is finalized, in compounding office stock for nonfood-producing animals and antidotes for food-producing animals. FDA is requesting nominations of bulk drugs substances to include on this list.
FDA intends to include a bulk drug substance on the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals only when all the following criteria are met:
- There is no marketed FDA-approved, conditionally approved, or indexed animal drug that can be used as labeled to treat the condition;
- There is no marketed FDA-approved animal or human drug that could be used in an extralabel manner under section 512(a)(4) or (a)(5) of the FD&C Act and 21 CFR part 530 to treat the condition;
- The drug cannot be compounded from a marketed FDA-approved animal or human drug consistent with 21 CFR part 530;
- Immediate treatment with the compounded drug is necessary to avoid animal suffering or death; and
- FDA has not identified a significant safety concern specific to use of the bulk drug substance in animals.
For bulk drug substances used to compound drugs intended for use as antidotes in food-producing animals, in addition to 1-5 above:
- There is sufficient scientific information for the veterinarian to determine appropriate withdrawal, withholding, or discard time(s) for meat, milk, eggs, or any food which might be derived from the treated animal(s).
Bulk drug substances that do not appear on the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals cannot be used to compound animal drugs for office stock. Veterinarians, pharmacists, or other interested stakeholders may nominate additional bulk drug substances using the nomination procedure described in the appendix of draft GFI #256.
List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals
Nominated Bulk Drug Substances That May NOT Be Used to Compound Office Stock Drugs or Antidotes for Use in Animals
Nominated Bulk Drug Substances Currently Under Review
Bulk Drug Substances Nominated Without Sufficient Supporting Evidence