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FDA Issues Revised Question & Answer Draft Guidance on Veterinary Feed Directive Regulation

FDA Issues Revised Question & Answer Draft Guidance on Veterinary Feed Directive Regulation

March 27, 2019

Today the U.S. Food and Drug Administration issued draft revised guidance for industry (GFI) #120, “Veterinary Feed Directive Regulation Questions and Answers.” The guidance aids industry in complying with the requirements of the Veterinary Feed Directive (VFD) final rule published in June 2015, and serves as a Small Entity Compliance Guide.

The VFD final rule outlines the process for authorizing use of animal drugs intended for use in or on animal feed that require the supervision of a licensed veterinarian and provides veterinarians in all states with a framework for authorizing the use of medically important antimicrobials in feed when needed for specific animal health purposes. The VFD final rule went into effect Oct. 1, 2015, and the implementation of Guidance for Industry (GFI) #213 as part of the agency’s initiative to promote the judicious use of antimicrobial drugs in food-producing animals was complete Jan. 1, 2017. Based on the recommendations in GFI #213, all production uses (e.g., growth promotion) of medically important antimicrobials approved for use in the feed or drinking water of food-producing animals were eliminated, and such drugs can now only be used for therapeutic purposes under veterinary oversight.

This updated version of the draft revised guidance enhances and expands upon the previous version released in September 2015 by adding 53 new Q&As and revising 14 Q&As on a wide range of topics related to the VFD final rule. The document is organized to help address the needs of all parties involved with a VFD order – veterinarians, VFD feed distributors (e.g., feed mills) and clients (i.e., owners or other caretakers of the animals). These changes were made in response to stakeholder feedback and comments submitted to FDA’s Center for Veterinary Medicine (CVM) since the VFD final rule went into effect and the implementation of GFI #213.

The comment period for this draft revised guidance is 60 days and will end May 28, 2019. For instructions on submitting comments to the FDA, please see the Federal Register notice.

Additional Resources

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.