FDA is announcing the availability of draft GFI #256 entitled “Compounding Animal Drugs from Bulk Drug Substances.”
FDA has generally exercised enforcement discretion with regard to animal drug compounding from bulk drug substances under certain circumstances when no other medically appropriate treatment options exist.
This draft guidance, a continuation of this practice, is intended to provide additional information and clarity to veterinarians and pharmacists about FDA's current thinking with respect to animal drug compounding from bulk drug substances.
We previously announced the availability of a draft guidance addressing this issue (GFI #230, “Compounding Animal Drugs from Bulk Drug Substances”) in the Federal Register of May 19, 2015 (80 FR 28624). In response to the comments received on GFI #230, we decided not to finalize that draft guidance, and instead are issuing draft GFI #256 for comment.
If finalized, this draft guidance will describe the circumstances under which, based on our current understanding of the risks of animal drugs compounded from bulk drug substances,
FDA does not intend to take enforcement action against pharmacies and veterinarians who compound animal drugs for violations of the FD&C Act's requirements for: (1) Approval; (2) adequate directions for use; and (3) current good manufacturing practices.
Learn more here.