Abstract

The U.S. Food and Drug Administration (FDA) has completed the implementation of Guidance for Industry #213, a process begun in 2013 to transition antimicrobial drugs with importance in human medicine (medically important antimicrobials) that are used in the feed or drinking water of food-producing animals to veterinary oversight and eliminate the use of these products in animals for production (e.g., growth promotion) purposes.¹ The FDA can now report that all affected drug applications have either aligned with the recommendations outlined in GFI #213, or their approvals have been voluntarily withdrawn. As a result of these changes, these products cannot be used for production (e.g., growth promotion) purposes and may only be used under the authorization of a licensed veterinarian. Of the 292 new animal drug applications initially affected by Guidance for Industry #213, 84 were completely withdrawn. Of the remaining 208 applications, 93 applications for oral dosage form products intended for use in water were converted from over-the-counter to prescription status, 115 applications for products intended for use in feed were converted from over-the-counter to veterinary feed directive status. Production (e.g., growth promotion) indications were withdrawn from all (31) applications that included such indications for use.

Literature Cited

1.  Food and Drug Administration. Center for Veterinary Medicine Update. Cited 2017 June 30. Available from https://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm535154.htm. (VIN update: The original link was not accessible as of 11/16/20.)