FDA announces GFI #263 has transitioned to prescription status


Status change of certain medically important antimicrobial drugs for animals from over-the-counter to prescription

The FDA has announced in an organizational release,1 the transition of guidance for industry (GFI) #263 from over the counter (OTC) to prescription (Rx) status. GFI #263 was introduced as a draft in 2019 and the final guidance was published in June 2021, according to the release. It outlined a 2-year timeline for animal drug sponsors to transition products to prescription status.

All affected animal drug sponsors opted to either voluntarily change the approved marketing status of its medically important antimicrobial drugs for animals or withdraw approval. With prescription status, all medically important antimicrobials for animals will require the authorization of a licensed veterinarian.1

The FDA stated in the release that specific requirements related to prescription animal drugs vary by state, including those related to the establishment of a valid veterinarian-client-patient relationship. The FDA will also allow existing inventory of OTC-labeled products that may already be in distribution channels to fully deplete before prescription is required.

A full list of approved animal drug applications affected by GFI #263 can be viewed on the FDA's website.


FDA announces transition of over-the-counter medically important antimicrobials for animals to prescription status. News release. FDA. June 12, 2023. Accessed June 12, 2023. https://www.fda.gov/animal-veterinary/cvm-updates/fda-announces-transition-over-counter-medically-important-antimicrobials-animals-prescription-status?utm_medium=email&utm_source=govdelivery

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