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  1. Animal Drug Compounding

Nominated Bulk Drug Substances Currently Under Review

Guidance for Industry #256 Compounding Animal Drugs from Bulk Drug Substances
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
Bulk Drug Substances Nominated Without Sufficient Supporting Evidence


These bulk drug substances were nominated and are currently being evaluated by FDA. As the Agency completes its review of these nominations, FDA will add them to the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals, or explain why they are not being added to the list. At this time, these substances cannot be used to compound animal drugs for office stock or antidotes.

For information on how to submit a bulk drug substance nomination, see the appendix of draft Guidance for Industry #256 Compounding Animal Drugs from Bulk Drug Substances.

DOGS, CATS, HORSES

  • Awaiting additional nominations

NON FOOD-PRODUCING MINOR SPECIES

  • Awaiting nominations

FOOD-PRODUCING SPECIES

  • Awaiting nominations