FDA In Brief: FDA issues draft guidance to voluntarily bring remaining approved over-the-counter medically important antimicrobial drugs for animals under veterinary oversight

September 23, 2019

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“The use of medically important antimicrobial drugs in animals should be under the oversight of licensed veterinarians who have the scientific and clinical training and knowledge to ensure that these important drugs are used judiciously. That’s why today the U.S. Food and Drug Administration is releasing a draft guidance for industry to help affected animal drug sponsors voluntarily change the marketing status of the remaining over-the-counter dosage forms of approved medically important antimicrobials, such as injectables, to prescription for both food-producing and companion animals,” said Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine. “Once the final version of this guidance is implemented, all medically important antimicrobial drugs for animals will need to be provided by licensed veterinarians. The FDA is committed to working with affected stakeholders on the implementation of this and other critical parts of our five-year plan to support antimicrobial stewardship and combat antimicrobial resistance.”

Today, the U.S. Food and Drug Administration released the draft guidance for industry (GFI) #263, “Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under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,” to help explain the recommended process for voluntarily bringing the limited number of 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 guidance 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 collaboratively with the FDA to voluntarily change OTC medically important antimicrobials used in the feed or drinking water of food-producing animals to Veterinary Feed Directive/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. Once draft GFI #263 has been finalized, and fully implemented by the FDA, working together with the affected stakeholders, 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.

The FDA is proposing a two-year implementation period. The agency intends to reach out to affected stakeholders and state partners to answer questions about the recommended process for voluntarily making these marketing status changes.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.