The U.S. Food & Drug Administration released Sept. 23 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).

FDA said this is part of the its five-year plan for Supporting Antimicrobial Stewardship in Veterinary Settings and builds upon the momentum generated by the implementation of GFI 213. Under GFI #213, animal drug sponsors worked in collaboration with FDA over a three-year period to voluntarily change OTC medically important antimicrobials used in the feed or drinking water of food-producing animals to veterinary feed directive (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, FDA said.

FDA has created a list of all new animal drug applications currently approved as OTC products that would be affected by GFI #263.

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FDA said it is proposing a two-year implementation period that would begin after the agency considers comments on the draft guidance and issues the final guidance.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events, such as meetings and conferences, to hear feedback and answer questions about the changes proposed in the draft guidance document.

FDA is also accepting public comments on this draft guidance for 90 days from the date of publication in the Federal Register.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, see www.regulations.gov/help.

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

FDA provided the following links to 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, and

* Antimicrobial Resistance Information from CVM.