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

March 22, 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.

Antibiotic Stewardship in Veterinary Medicine Brochure - https://www.fda.gov/media/162067/download
Español - https://www.fda.gov/media/162068/download

Antibiotic Stewardship Poster - https://www.fda.gov/media/162075/download
Español - https://www.fda.gov/media/162076/download

Antibiotic Stewardship in Beef and Dairy Cattle - https://www.fda.gov/media/162069/download
Español - https://www.fda.gov/media/162070/download

Antibiotic Stewardship in Poultry - https://www.fda.gov/media/162071/download
Español - https://www.fda.gov/media/162072/download

Antibiotic Stewardship in Sheep and Goats - https://www.fda.gov/media/162073/download
Español - https://www.fda.gov/media/162074/download

In addition, CVM has posted a list of affected applications on its website as well as a Farmer and Rancher Q&A.

[Source: FDA CVM]