The U.S. Food & Drug Administration (“FDA”) announced in an early morning press release on November 7, 2017, that it is withdrawing the draft Guidance for Industry #230, “Compounding Animal Drugs from Bulk Drug Substances.”1 FDA confirmed that it does not intend to finalize the current draft guidance. Rather, it will issue a new draft guidance in early 2018 for public comment.
The draft guidance was issued in May 2015 and proposed conditions under which FDA generally would not take action against the compounding of animal drugs from bulk drug substances. The draft guidance immediately received a flurry of comments from industry stakeholders contesting not only the authority of FDA to regulate the compounding of animal drugs, but also its position that federal law does not permit the compounding of animal drugs from bulk drug substances. Industry stakeholders also took issue with the specific parameters under which FDA proposed to regulate the compounding of animal drugs from bulk substances.