The 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, we expect 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/CVM is conducting outreach to increase awareness about this expected change. Outreach efforts so far have included disseminating information in September to some target audiences (TX, AZ, OR) through radio and social media.
CVM has also developed some written materials that we hope will be helpful. Below are links for species-specific fact sheets - these include 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.
Antibiotic Stewardship in Veterinary Medicine Brochure – https://www.fda.gov/media/162067/download
Antibiotic Stewardship Poster – https://www.fda.gov/media/162075/download
Antibiotic Stewardship in Beef and Dairy Cattle - https://www.fda.gov/media/162069/download
Antibiotic Stewardship in Poultry – https://www.fda.gov/media/162071/download
Antibiotic Stewardship in Sheep and Goats – https://www.fda.gov/media/162073/download
In addition, CVM has posted a list of affected applications on its website as well as a Farmer and Rancher Q&A.