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OTC Antimicrobials Changing to Rx Starting in June
Effective June 11, 2023, the FDA will be enforcing GFI 263, which outlines the process for animal drug sponsors to voluntarily change the approved marketing status of certain medically important antimicrobial drugs from over-the-counter (OTC) to prescription (Rx).
Effective June 11, 2023, the FDA will be enforcing GFI 263, which outlines the process for animal drug sponsors to voluntarily change the approved marketing status of certain medically important antimicrobial drugs from over-the-counter (OTC) to prescription (Rx).
This legislation is a result of the FDA’s efforts to combat antimicrobial resistance (AMR) by promoting the judicious use of medically important antimicrobials in animals.
As a result, some products purchased and used as OTC today may require a prescription as of June 11.
Review the resources below to learn more about GFI #263, the list of drug applications affected, and FAQs from the FDA.
List of Approved New Animal Drug Applications Affected by GFI #263
Guidance for Industry #263
GFI #263: Frequently Asked Questions for Farmers and Ranchers
Why is FDA issuing this guidance?
Why would I need to consult a veterinarian to get the same drugs I’ve always used?
Why is FDA focusing on the judicious use of antimicrobials on farms and ranches instead of human antimicrobial use?
How will farmers and ranchers continue to get access to the antimicrobials they need for sick animals?
Will a veterinarian be required to physically examine each animal before writing a prescription?
When will these products change from over the counter (OTC) to prescription (Rx)?
Frequently Asked Questions provided by the FDA's website. Read the full article here.
Earn Free CE Credit While Learning About These Updates
Updates for Production Animal Veterinarians
About This Webinar:
FDA Updates and the Impact on VFDs
Antimicrobial Regulation Changes and Impact on Prescriptions
Foreign Animal Disease Preparedness and the Importance of Electronic Movement Records
US Swine Health Improvement Plan and Focus on Biosecurity, Traceability, and Surveillance
Effective June 11, 2023, the FDA will be enforcing GFI 263, which outlines the process for animal drug sponsors to voluntarily change the approved marketing status of certain medically important antimicrobial drugs from over-the-counter (OTC) to prescription (Rx).
This legislation is a result of the FDA’s efforts to combat antimicrobial resistance (AMR) by promoting the judicious use of medically important antimicrobials in animals.
As a result, some products purchased and used as OTC today may require a prescription as of June 11.
Review the resources below to learn more about GFI #263, the list of drug applications affected, and FAQs from the FDA.
List of Approved New Animal Drug Applications Affected by GFI #263
Guidance for Industry #263
GFI #263: Frequently Asked Questions for Farmers and Ranchers
Why is FDA issuing this guidance?
Why would I need to consult a veterinarian to get the same drugs I’ve always used?
Why is FDA focusing on the judicious use of antimicrobials on farms and ranches instead of human antimicrobial use?
How will farmers and ranchers continue to get access to the antimicrobials they need for sick animals?
Will a veterinarian be required to physically examine each animal before writing a prescription?
When will these products change from over the counter (OTC) to prescription (Rx)?
Frequently Asked Questions provided by the FDA's website. Read the full article here.
Earn Free CE Credit While Learning About These Updates
Updates for Production Animal Veterinarians
About This Webinar:
FDA Updates and the Impact on VFDs
Antimicrobial Regulation Changes and Impact on Prescriptions
Foreign Animal Disease Preparedness and the Importance of Electronic Movement Records
US Swine Health Improvement Plan and Focus on Biosecurity, Traceability, and Surveillance
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