Veterinary Compounding: FDA Publishes Long-Awaited Guidance

The FDA has released Compounding Animal Drugs from Bulk Drug Substances, also known as Guidance for Industry (GFI) #256. The document describes the agency’s approach to situations where veterinarians need access to unapproved drugs compounded from bulk drug substances (BDS) to provide appropriate care for the medical needs of the diverse species they treat when no FDA-approved (including conditionally approved) or indexed drugs can be used to treat the animal.