September 23, 2019

Today, the U.S. Food and Drug Administration released draft guidance for industry (GFI) #263 to explain the recommended process for voluntarily bringing remaining approved animal drugs containing antimicrobials of human medical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). 

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FDA is proposing a two-year implementation period that would begin after the agency considers comments on the draft guidance and issues the final guidance.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events, such as meetings and conferences, to hear feedback and answer questions about the changes proposed in the draft guidance document. 

Additionally, the FDA is accepting public comments on this draft guidance for 90 days from the date of publication in the Federal Register.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

To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2019-D-3614 on each page of your written comments.

Dockets Management Staff
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Comments will be accepted at any time, but should be submitted no later than December 24, 2019, to ensure that the FDA takes the information into consideration before it begins work on the final version of this guidance.

Additional Information

• Draft Guidance for Industry #263: Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter 
• Federal Register, Notice of Availability: Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter; Draft Guidance for Industry  
• List of Approved New Animal Drug Applications Affected by Draft GFI #263
• Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019-2023
• Antimicrobial Resistance Information from CVM