FDA Releases Draft Guidance on Bringing Remaining Approved Over-The-Counter Medically Important Antimicrobial Drugs Used for Animals Under Veterinary Oversight

Today, the U.S. Food and Drug Administration released draft guidance for industry (GFI) #263 to explain the recommended process for voluntarily bringing remaining approved animal drugs containing antimicrobials of human medical importance (i.e., medically important) under the oversight of licensed veterinarians by changing the approved marketing status from over-the-counter (OTC) to prescription (Rx). [Source: FDA 23 Sept 2019]

This is part of the FDA's Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings and builds upon the momentum generated by the successful implementation of GFI #213. Under GFI #213, animal drug sponsors worked in collaboration with FDA over a 3-year period to voluntarily change OTC medically important antimicrobials used in the feed or drinking water of food-producing animals to VFD/Rx marketing status and eliminated the use of these products for production purposes (e.g., growth promotion). These changes took effect in January 2017.

A limited number of other dosage forms of medically important antimicrobials, such as injectables, are currently marketed as OTC products for both food-producing and companion animals. When Draft GFI #263 has been finalized and fully implemented, all dosage forms of all approved medically important antimicrobials for all animal species can only be administered under the supervision of a licensed veterinarian and only when necessary for the treatment, control or prevention of specific diseases.

FDA is proposing a two-year implementation period that would begin after the agency considers comments on the draft guidance and issues the final guidance. In addition, the FDA plans to engage with affected stakeholders and state partners at public events, such as meetings and conferences, to hear feedback and answer questions about the changes proposed in the draft guidance document.

Additionally, the FDA is accepting public comments on this draft guidance for 90 days from the date of publication in the Federal Register. To electronically submit comments to the docket, visit https://www.regulations.gov and type FDA-2019-D-3614 in the search box. For assistance in submitting electronic comments, please see https://www.regulations.gov/help.

For more information, visit FDA.