On June 11, 2021, the FDA announced that all medically important antibiotics currently available over the counter (OTC) will transition to prescription (Rx) status within the next two years.
The FDA has asked drug companies to voluntarily change the labels on their OTC antibiotics to contain the following Rx statement: “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.” This change is the result of a long term plan to decrease antibiotic resistance by moving all medically important antibiotics under veterinary supervision.
While the label changes must occur by June 11, 2023 some products may become prescription before that time as the manufacturers proactively update their labels.
Once fully implemented, antibiotics will NOT be available at farm stores. Antibiotics could be purchased through a veterinary clinic, veterinary pharmacy or distributor so long as the veterinarian provides a prescription to that supplier.
Common antibiotics affected by this change are penicillin, oxytetracycline (LA200, Agrimycin, Biomycin and other generic formulations), injectable and oral sulfadimethoxine (Albon and Sustain III), mastitis tubes (Today, Tomorrow, GoDry, MastiClear and Albadry) and Tylan. Products NOT affected are coccidiostats (Corid, Deccox, Rumensin, CalfPro, etc.), dewormers and implants.
To prepare, farmers need a valid veterinary client patient relationship (VCPR). While it is not necessary for a veterinarian to personally examine every animal, the veterinarian must visit the farm and be aware of animal management before writing a prescription.
Contact us for more information about these changes and how they impact you.