Changes Coming to OTC Medications GET READY FOR NEW FDA RULE

It may have gotten lost during the pandemic, but the U.S. Food and Drug Administration’s (FDA) announcement back in June 2021 regarding medically important antimicrobials is about to change how you get access to common over-the-counter (OTC) medications for your animals.

Known as Guidance for Industry #263, the FDA unveiled a fiveyear action plan for supporting antimicrobial stewardship that builds on the what the Center for Veterinary Medicine (CVM) has already done to support the judicious use of antimicrobials in animals. It’s driven by the concept that medically important antimicrobial drugs should only be used in animals when necessary for the treatment, control, or prevention of specific diseases.

Pork producers have practiced antimicrobial stewardship for years under the purview of the veterinary-client-patient (VCPR) relationship they maintain with their herd veterinarians. While prescription-only medications required direct veterinary purchase approval, OTC ones did not. Nonetheless, whole-herd health management has always been a joint, comprehensive effort and responsibility.

When GFI #263 takes effect on June 11, the importance of having a valid VCPR expands further as it will require a prescription for long-time medications. Those that will be affected by the new FDA rule include those that contain:

1 OXYTETRACYCLINE

2 3 4 5 6

PENICILLIN

SULFA-BASED ANTIBIOTICS (SULFADIMETHOXINE AND SULFAMETHAZINE)

For more information about how GFI #263 may affect your herd health management, contact your herd veterinarian. Also visit FDA’s FAQs for Farmers and Ranchers by scanning the QR code.