FDA aims to bring more antimicrobials under veterinary supervision

The FDA has issued guidance that aims to bring more antimicrobials deemed “medically important” under veterinary supervision.

The agency’s new guidance outlines the process for animal drug sponsors to voluntarily change the approved marketing status of certain medically important antimicrobial drugs. Once the change is made, these drugs can only be used in animals under the supervision of a licensed veterinarian.

This new guidance for industry—officially named GFI No. 263—is an extension of GFI No. 213. Under that policy, animal drug sponsors voluntarily changed over-the-counter medically important antimicrobials used in the feed or drinking water of food-producing animals to veterinary feed directive or prescription marketing status, with the goal of eliminating the use of these products for production purposes like growth promotion.

According to the FDA, since GFI No. 213 was implemented, about 96% of medically important antimicrobials used in animals are now under veterinary oversight. The remaining 4% include other forms, such as injectables and topicals, which are covered by the new guidance for industry.