November 7, 2017
The U.S. Food and Drug Administration is withdrawing draft Guidance for Industry (GFI) #230, “Compounding Animal Drugs from Bulk Drug Substances” in order to clarify that the agency does not plan to finalize the current draft, but instead intends to issue a new draft for public comment next year.
The draft guidance issued in May 2015 proposed conditions under which the FDA generally would not intend to take action against the compounding of animal drugs from bulk drug substances, with the goal of making such animal drugs available for patient care without jeopardizing the safety of animals and humans or compromising the animal drug approval process.
Current law does not permit compounding of animal drugs from bulk drug substances, but the FDA recognizes that 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.
After reviewing the comments submitted to the docket, the FDA decided not to finalize the current draft guidance, and will instead develop and issue a new draft guidance. In developing the new draft, the FDA will carefully consider the issues that are specific to compounding of animal drugs, including the significance of using compounded drugs as a treatment option in various veterinary settings and animal species.
FDA intends to publish the new draft in early 2018 for public comment. As FDA develops a new draft guidance, it will continue to focus on the safety of compounded animal drugs and intends to take action if the agency becomes aware of an animal or human safety concern associated with the use of an animal drug compounded from bulk drug substances. In the interim, veterinarians or other interested stakeholders are encouraged to contact FDA’s Center for Veterinary Medicine (CVM) at AskCVM@fda.hhs.gov if they have questions regarding compounding of animal drugs.