FDA Finalizes Guidance to Bring Remaining Approved Over-The-Counter Medically Important Antimicrobial Drugs Used for Animals Under Veterinary Oversight

The U.S. Food and Drug Administration finalized guidance for industry (GFI) #263 to outline the process for animal drug sponsors to voluntarily change the approved marketing status of certain medically important antimicrobial drugs from over-the-counter (OTC) to prescription (Rx). Once this change is made, these important drugs can only be used in animals under the supervision of a licensed veterinarian.

GFI #263 is an extension of the successful implementation of GFI #213External Link Disclaimer. Under GFI #213, animal drug sponsors worked with FDA to voluntarily change OTC medically important antimicrobials used in the feed or drinking water of food-producing animals to veterinary feed directive (VFD) or Rx marketing status and eliminate the use of these products for production purposes (e.g., growth promotion). With the successful implementation of GFI #213, approximately 96 percent of medically important antimicrobials used in animals are now under veterinary oversight.