Over-the-Counter Antibiotics Will Require Veterinary Oversight (Rx) Beginning in June of 2023

Dr. Gustavo M. Schuenemann, Department of Veterinary Preventive Medicine, The Oho State University

In June of 2021, the U.S. Food and Drug Administration (FDA) announced that all medically important antimicrobials will move from over-the-counter (OTC) to prescription (Rx) within a 2- year implementation period. The Center for Veterinary Medicine guidance for industry #263 (GFI 263) outlines the process for animal drug suppliers to change the approved marketing status of certain antimicrobial drugs for use in non-food (companion), food-producing animals, or both, that are currently approved with OTC marketing status. In 2003, FDA ranked antimicrobials according to their relative importance to human medicine: “critically important,” “highly important,” or “important.” The FDA considers all antimicrobial drugs listed in Appendix A to GFI #152 to be “medically important”.

On September 14, 2018, the FDA unveiled a 5-year action plan for supporting antimicrobial stewardship in veterinary settings. The FDA is implementing GFI #263 as part of its broader plan to control antimicrobial resistance via the judicious use of antimicrobials in animals within our community and food supply. This process is driven by the concept that medically important antimicrobial drugs should only be used in animals when deemed necessary for the treatment, control, or prevention of specific diseases. The FDA, via GFI #263, places the responsibility for the use of medically important antimicrobials under the oversight of a licensed veterinarian (from large to small animals).

What species are included?

From companion dogs and cats to backyard poultry, and from rabbits and show pigs to large livestock farms. The same restrictions will apply to all companion and farm animal species.

When will these new changes become effective?

Beginning in June of 2023, or sooner, depending on when the manufacturer changes their labeling.

What do these federal regulatory changes mean to you and your livestock operation, as well as veterinary practices?

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 that small and large animal veterinarians should be prepared for an increase in calls and visits from animal owners who previously may have purchased these drugs over the counter at their local farm supply store. To continue using medically important antimicrobials, you may 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.

Prevention and Future Considerations

There are effective ways to reduce the dependency of antimicrobials. Every livestock operation is an integrated system; decisions made in one area of the farm will have an impact on other areas of the farm. Perhaps reviewing the consistency of your feeding program (making sure animals receive a balanced diet), vaccination program, considering the genetic selection of animals for improved health, or visiting new housing facilities designed for best animal comfort are holistic ways of reducing antimicrobial use at the herd or flock level. An ounce of prevention is worth a pound of cure! Look for more upcoming articles on prevention and ways to reduce antimicrobial use.

Helpful resources:

  1. You can download a VCPR template developed by the Ohio Veterinary Medical Association Drug Use Task Force at: https://vet.osu.edu/extension/general-food-fiber-animal-resources.
  1. CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue                    to be        Available                 Over-the-Counter:             https://www.fda.gov/regulatory- information/search-fda-guidance-documents/cvm-gfi-263-recommendations-sponsors- medically-important-antimicrobial-drugs-approved-use-animals/
  1. List        of     Approved    New    Animal    Drug    Applications    Affected    by   GFI     #263: https://www.fda.gov/animal-veterinary/judicious-use-antimicrobials/list-approved-new-  animal-drug-applications-affected-gfi-263/.
  1. Veterinary Feed Directive (VFD): https://vet.osu.edu/sites/vet.osu.edu/files/documents/extension/Brochure_VFD.pdf
  1. FDA 2003. Guidance for Industry #152, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern,” Appendix A. https://www.fda.gov/media/69949/download.