June 15, 2021

Finalised US FDA guidance further restricts use of critical antimicrobials in animals



The US Food and Drug Administration (FDA) has finalised a guidance for industry (GFI), numbered #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 #213. 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 (for example, growth promotion).


With the successful implementation of GFI #213, approximately 96% of medically important antimicrobials used in animals are now under veterinary oversight.


The remaining 4% of such antimicrobials currently marketed as OTC products for food-producing and companion animals include other dosage forms, such as injectables and topicals.


Once the recommendations in GFI #263 have been fully implemented, all dosage forms of medically important antimicrobials approved for use in animals could only be administered under the supervision of a licensed veterinarian, and only when necessary for the treatment, control or prevention of specific diseases.


Although animal owners would still have access to medically important antimicrobials to address animal health issues, they would need to consult their veterinarian to obtain a prescription.