FDA releases new draft guidance on compounded animal drugs

  |   Federal Regulatory

The FDA is requesting public comment on new draft guidance for industry (GFI) #256, “Compounding Animal Drugs from Bulk Drug Substances.” The new guidance, if finalized, would guide veterinarians on situations where FDA does not intend to take action for certain violations when pharmacists and veterinarians compound animal drugs from bulk substances.

In 2015, FDA published draft guidance on the issue of compounding animal drugs, but after receiving comments from veterinary groups and other stakeholders, they withdrew the draft guidance to work on potential new guidance.

The agency is also developing the “List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals.” Comments on draft GFI #256 will be accepted at any time but should be submitted no later than February 18, 2020. To electronically submit comments to the docket, visit and type FDA-2018-D-4533 in the search box. (FDA)