FDA releases draft guidance on animal drug compounding from bulk drug substances
The U.S. Food and Drug Administration (FDA) this week released a draft “Guidance for Industry (GFI) #230, Compounding Animal Drugs from Bulk Drug Substances.” Current law does not permit compounding of animal drugs from bulk drug substances, but the FDA recognizes that there are limited circumstances when an animal drug compounded from bulk drug substances may be an appropriate treatment option. FDA’s GFI #230 outlines specific conditions under which the agency generally does not intend to take action against state-licensed pharmacies, veterinarians, and facilities registered as outsourcing facilities when drugs are compounded for animals from bulk drug substances.
Comments on the draft guidance are being accepted through mid-August. Access the FDA website to read the entire draft guidelines.