Expert advice
Over-the-Counter Antibiotics Changing to Prescription Only By Dr. Lee Jones, M.S., D.V.M, Associate Professor, Department of Population Health, University of Georgia Beginning in June 2023, you won’t be able to purchase over-the-counter (OTC) antibiotics at the local farm supply store. On June 10, 2021, the U.S. Food and Drug Administration (FDA) finalized Guidance for Industry #263 (GFI 263), which outlines the process for animal drug sponsors to voluntarily change the approved marketing status of certain medically important antimicrobial drugs from overthe-counter (OTC) to prescription (Rx). GFI 263 provides for a two-year implementation period. While some products may change from OTC to Rx status beforehand, by June 2023 all OTC antibiotics will become Rx only. Some products were voluntarily pulled by companies; other products, such as injectable penicillin and oxytetracycline (both 200 mg/ml and 300 mg/ml), will be available by Rx only. FDA took this action to attempt to address the concern of antibiotic resistance in human and animal health. Antimicrobial use in humans, animals and even plants may contribute to the development of antimicrobial resistance in microorganisms. Any antibiotic use can contribute to antibiotic resistance, so it’s important to avoid unnecessary 22
GEORGIA CATTLEMAN | AUGUST 2022
or inappropriate uses of antibiotics. GFI 263 puts responsibility for the use of medically important antimicrobials into the hands of veterinarians, who are trained to understand not only when these medications are needed, but also what is the appropriate drug, dose, duration and administration method to resolve infection and protect animal health and our food supply. The veterinarian’s expertise is critical to ensuring the responsible use of antibiotics in animals. https://www.avma.org/resources-tools/onehealth/antimicrobial-use-and-antimicrobial-resistance/ over-counter-antimicrobials-changing-prescription-only. In years past, farmers could go to a farm supply store and purchase antibiotics or order some of the products through online companies without involving a veterinarian. Soon, though, farmers will need to plan ahead and discuss buying their antibiotics with a veterinarian. The veterinarian can either sell the antibiotic products directly to farmers or provide a prescription so the farmer can purchase antibiotics through another supplier. All prescriptions or Rx will require a veterinaryclient-patient-relationship (VCPR). For Georgia, this
