Be Prepared: Transitioning Certain OTC Antimicrobial Products to Rx June 2023

Mar 24, 2023

FDA published Guidance for Industry (GFI) #263 in June 2021 which outlined a plan for transitioning certain over-the-counter (OTC) antimicrobial products for animals to prescription (Rx) status. As outlined in FDA's Guidance for Industry (GFI) #263, FDA expects approved animal drug products containing medically important antimicrobials that are currently available as OTC products to transition to Rx status beginning in June 2023. To help prepare for this transition, FDA Center for Veterinary Medicine (CVM) is conducting outreach to increase awareness about this expected change.

FDA CVM has developed written materials with information on products/indications that will be transitioning as part of GFI 263 and information on how interested animal owners can locate a vet. Also linked below are a brochure and poster which detail the importance of veterinary involvement as products transition to Rx.

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Video: ASF Spread and Control Insights - Dr. Carles Vilalta

In this episode of The Swine it Podcast Show Canada, Dr. Carles Vilalta, epidemiologist at IRTA CReSA in Spain, explains the current African swine fever situation, including origin, transmission, and control strategies. He highlights the role of human activity, wild boar dynamics, and biosecurity measures to protect commercial farms. Learn how surveillance and field actions shape disease containment. Listen now on all major platforms!

"ASF demonstrates slow animal to animal transmission despite high infectivity, making it a clumsy disease that depends heavily on human mediated spread."

Meet the guest: Dr. Carles Vilalta / carlesvilalta is an epidemiologist, swine veterinarian, and researcher at IRTA-CReSA in Spain. His work focuses on epidemiology, swine health, disease surveillance, and research support for government and industry programs. Learn more from Dr. Carles Vilalta on The Swine it Podcast Show Canada, available on all major platforms.