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FDA issues revised Q&A draft guidance on VFD regulation

Draft revised guidance enhances and expands on previous version released in September 2015.

On March 27, the U.S. Food & Drug Administration issued a draft revised guidance for industry (GFI) #120, “Veterinary Feed Directive Regulation Questions & Answers.”

FDA said the guidance is intended to aid 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."

According to FDA, the updated version of draft revised GFI #120 enhances and expands upon the previous version released in September 2015 by adding 53 new questions and answers (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 (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 agency said.

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

The VFD final rule outlines the process for authorizing 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, FDA said. The VFD final rule went into effect on Oct. 1, 2015, and the implementation of GFI #213 as part of the agency’s initiative to promote the judicious use of antimicrobial drugs in food-producing animals was completed on Jan. 1, 2017.

Based on the recommendations in GFI #213, all production uses (such as growth promotion) of medically important antimicrobials in the feed or drinking water of food-producing animals were eliminated, and such drugs can now be used only for therapeutic purposes under veterinary oversight, FDA pointed out.

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