The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) today published draft Guidance for Industry #263 outlining a process for animal health companies to make label changes to bring all medically important antibiotics used in food animals under veterinary supervision.
The animal health industry and CVM worked cooperatively to implement previous Guidance for Industry documents #209 and #213. These policies required veterinary oversight for all medically important antibiotics used in animal feed or water, which account for over 90 percent of the antibiotic use, and was fully implemented on January 1, 2017. Today’s guidance, when finalized, will bring all remaining medically important antibiotics – generally those administered via injection – under veterinary supervision within two years. The animal health industry will again partner with the agency to make the necessary label changes to implement this policy.
The involvement of a licensed veterinarian in the use of medically important antibiotics is key to protecting both animal health and human health. Cooperative implementation of this policy will fulfill an animal health industry commitment to the Center for Disease Control’s AMR Challenge.
Today’s guidance is part of FDA’s five-year plan to combat antimicrobial resistance and AHI continues to engage with the agency on additional science-based steps to ensure judicious use of medically important antibiotics.