FDA Compounding Guidance

02Jan '18

FDA Compounding Guidance


The FDA has recently withdrawn the draft Guidance for Industry #230 pertaining to “Compounding Animal Drugs from Bulk Drug Substances.” In response to input from veterinarians and the AVMA, the agency has withdrawn the draft as a statement that they do not plan to finalize the current draft. The original draft was issued May 2015 and outlines standards by which veterinarians can use bulk drug substances to compound medications for animal use without jeopardizing human or animal health. The withdrawal of the current draft will not have any impact on the current regulation of animal drug compounding. A new draft GFI is expected in 2018.

Under the current law, compounding from FDA-approved drugs is legal as long as they comply with the FDA’s Extra-label drug use rules and state rules. The current law does not allow the compounding of drugs from bulk drugs substances, but the FDA issued the draft GFI #230 to outline areas where compounding would be permissible. Due to the nature of veterinary medicine, there is often no approved drugs suitable for modification for veterinary patients. In these circumstances, it is appropriate and permissible to compound a medication from bulk drug substances.

The new draft guidance will focus on issues specific to compounding for animal use and will continue to focus on safety issues involved with compounding animal drugs.

The new draft is anticipated to be released in the early part of 2018 for public comment. In the meantime, the FDA is encouraging veterinarians to contact their Center for Veterinary Medicine if questions arise pertaining to the use of compounded drugs. The FDA states that until the new draft is published, they will look at the entire circumstances before taking enforcement action for illegal animal drug compounding.

releated posts