As part of its overall efforts to address compounded drugs, the U.S. Food and Drug Administration today 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.

The Drug Quality and Security Act, which amended the human drug compounding provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and created a new section 503B of the FD&C Act for outsourcing facilities, provides certain statutory exemptions for compounded human drugs, but the law does not apply to drugs compounded for animal use.

There are circumstances where there is no approved drug that can be used or modified through compounding to treat a particular animal with a particular condition.  In those limited situations, an animal drug compounded from bulk drug substances may be an appropriate treatment option.

In addition, the FDA is developing a list of bulk drug substances that facilities registered as outsourcing facilities under section 503B can use to compound drugs for an individual animal patient or veterinarian office use under specified conditions.  In a separate Federal Register notice, the FDA is requesting public input on which bulk drug substances should be placed on this list.