FDA Seeks Comment on Animal Drug Compounding Documents

The comment period for the animal drug compounding draft guidance and list of bulk drug substances closes on Nov. 16.
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In May the U.S. Food and Drug Administration (FDA) 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 could be an appropriate treatment option. The 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 can be an appropriate treatment option

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