FDA finalizes GFI #120

monticellllo/stock.adobe.com

The FDA announced that it has finalized Guidance for Industry (GFI) #120: Veterinary Feed Directive (VFD) Regulation Questions and Answers to help guide veterinarians, clients, and stakeholders involved in veterinary feed directives.

According to an FDA news release,¹ GFI #120 complies with the VFD final rule that went into effect in 2015 and outlines the authorization process of approving animal drugs in the feed of food-producing animals that require veterinary oversight. This also includes antimicrobials that are medically important when needed, specifically for animal health purposes. The final guidance will also serve as a Small Entity Compliance Guide.

The FDA disclosed in its release that despite the core recommendations in final GFI #120 remaining the same as the revised draft guidance issued in 2019, the language in the final version better aligns with industry practices within the industry.¹ The final rule also clarifies flexibilities to help reduce burdens on distributors, producers, and veterinarians. For example, the FDA provided a hypothetical scenario to illustrate the responsibility of shareholders under the final rule.

The changes were informed by public comment on the revised draft guidance and feedback stakeholders provided during VFD inspections and the final guidance reflects a technical amendment to the VFD final rule from 2020 and an updated contact information and online resources. When it comes to VFD, inspections are conducted by the FDA to verify that the antimicrobial used in or on the feed of food-producing animals is properly.¹ The FDA VFD Inspection data found that of the inspected stakeholders, 95% have complied with the VFD final rule.²

Through the final GFI #120, the FDA hopes to give any stakeholders more clarification to better understand and implement the VFD requirements which in turn improve antimicrobial stewardship.

References

1. FDA finalizes guidance to provide further clarity on Veterinary Feed Directives. News release. US Food and Drug Administration. April 26, 2024. Accessed April 26, 2024. https://www.fda.gov/animal-veterinary/cvm-updates/fda-finalizes-guidance-provide-further-clarity-veterinary-feed-directives?utm_medium=email&utm_source=govdelivery
2. FDA-TRACK: Progress on FDA’s support of antimicrobial stewardship in veterinary settings. US Food and Drug Administration. Published online 2024. Accessed April 26, 2024. https://www.fda.gov/about-fda/fda-track-agency-wide-program-performance/fda-track-progress-fdas-support-antimicrobial-stewardship-veterinary-settings#VFD