FDA finalizes guidance to provide further clarity on Veterinary Feed Directives

The U.S. Food & Drug Administration has finalized Guidance for Industry (GFI) #120: Veterinary Feed Directive Regulation Questions and Answers to assist stakeholders involved with veterinary feed directives (VFDs) – veterinarians, VFD feed distributors (medicated feed mills, feed retailers) and clients (owners or other caretakers of the animals) – in complying with the Veterinary Feed Directive (VFD) final rule that published in 2015. The VFD final rule outlines the process for authorizing the use of approved animal drugs in the feed of food-producing animals that require veterinary oversight, including medically important antimicrobials when needed for specific animal health purposes. This final guidance also serves as a Small Entity Compliance Guide.

Although the core recommendations in final GFI #120 remain the same as the revised draft guidance issued in 2019, the language in the final guidance better aligns with existing industry practices and clarifies flexibilities to reduce the burden on veterinarians, producers, and distributors. One way the FDA offers clarification is by including hypothetical scenarios to illustrate stakeholder responsibilities under the VFD final rule in a more tangible way. These changes were informed by public comment on the revised draft guidance and feedback from stakeholders during VFD inspections. The final guidance reflects a 2020 technical amendment to the VFD final rule, as well as updated contact information and links to online resources.

The FDA conducts VFD inspections to verify that antimicrobials used in or on the feed of food-producing animals are being authorized appropriately. These inspections also help to ensure that veterinarians, animal producers, and VFD medicated feed distributors have the information they need to comply with the VFD final rule. According to FDA VFD inspection data , 95 percent of inspected stakeholders have been in compliance with the VFD final rule. The agency hopes that the clarifications detailed in final GFI #120 will further enhance stakeholder understanding and implementation of VFD requirements, in turn improving antimicrobial stewardship in veterinary settings.