Over-the-Counter Antibiotics will require Veterinary Oversight (Rx) beginning in June 2023 – Start Planning Now!
In June of 2021, the U.S. Food and Drug Administration (FDA) has announced that all medically important antimicrobials will move from over-the-counter (OTC) to prescription (Rx) only as of June 2023. The Center for Veterinary Medicine guidance for industry #263 (GFI 263) outlines the process.
This means that the injectable, oral, intramammary, and topical forms of antibiotics will require a prescription from a licensed veterinarian.
What species are included?
This applies to all companion and farm animal species.
When do these new changes become effective?
Beginning in June of 2023, or sooner, depending on when the manufacturer changes their labeling.
What do this mean to you and your livestock operation?
By June of 2023, all medically important antibiotics currently available at most feed or farm supply stores will now require veterinary oversight (written Rx) to be used in animals, even if the animals are not intended for food production.
Examples of affected antibiotics include injectable penicillin and oxytetracycline.
In addition, some retail suppliers who were able to sell these drugs/products in the past may no longer sell them after June of 2023.
This means in order to continue using medically important antimicrobials, you will need to establish a veterinary-client-patient relationship (VCPR). Consult your veterinarian for more information.
What is a veterinarian-client-patient-relationship?
A veterinarian-client-patient-relationship (VCPR) is defined by the American Veterinary Medical Association as the basis for interaction among veterinarians, their clients, and their patients and is critical to the health of your animal(s). The practical explanation is that it is a formal relationship that you have with a veterinarian who serves as your primary contact for all veterinary services and is familiar with you, your livestock/animals, and your farm operation. This veterinarian is referred to as your Veterinarian of Record (VoR), and both the VoR and the client should sign a form to document this relationship.
How will this work?
The new guidance does not require producers to purchase antibiotics through their veterinarian. Producers can use online pharmacies as long as they have a prescription.
The guidance does not affect antiparasitic drugs.
- FDA GFI #263: Frequently Asked Questions for Farmers and Ranchers
- Full list of antibiotics affected by GFI 263
- Full list of antibiotics affected by GFI 263 (by Trade Name)
- Prepare Now for FDA Changes in 2023, Sheep Industry News, September 2022
- ASI Monthly Research Podcast: Antibiotic Resistance & Upcoming Changes to US Policy with Rosie Busch, DVM, July 2022
- Antibiotic Resistance & U.S. Policies, Roselle Busch, DVM, University of California-Davis, Sheep Industry News, May 2022
- FDA Antimicrobial Resistance Plan to Change Over-the-Counter Animal Antimicrobial Drugs to Prescription Basis – Roselle Busch, DVM, UC Davis, ASI Annual Convention, January 2022
- AASRP Establishing and Maintaining the VCPR in a Small Ruminant Practice
Responsible stewardship practices include actions that preserve the effectiveness of antibiotics while maintaining animal health. This includes:
- Only using antibiotics when necessary to manage illness in animals.
- Establishing best management practices, like use of vaccines, and disease prevention plans to reduce the overall need for antibiotics.
- Livestock owners and veterinarians working together to make decisions that improve animal health and welfare long-term.