Some over-the-counter antibiotics to move under veterinary oversight

Friday, May 5, 2023

Media Contact: Kaylie Wehr | Coordinator, Marketing and Public Relations | 405-744-6740 | kaylie.wehr@okstate.edu

On June 11, 2021, the United States Food and Drug Administration (FDA) finalized Guidance for Industry (GFI) No. 263 requesting that participating animal drug companies voluntarily transition certain antimicrobials from over-the-counter availability to veterinary prescription required over a two-year period. The target date to introduce new prescription labels into the market is June 11, 2023.

With June quickly approaching, it is important for producers and animal owners to be aware of and understand what these changes will mean. Dr. Rosslyn Biggs — assistant clinical professor, beef cattle extension specialist and director of continuing education at the Oklahoma State University College of Veterinary Medicine — provides insight into these changes.

GFI No. 263 is part of an FDA effort to address antimicrobial resistance. The concept is that medically important antimicrobial drugs should only be used in animals when necessary for the treatment, control or prevention of specific diseases and with veterinary consultation and oversight.

Medically important antimicrobials are those products with importance in human medicine. Examples commonly used in beef cattle include antibiotics such as tetracycline and penicillin.

GFI No. 263 is an expansion of the previous GFI No. 213. Many producers will recall GFI No. 213 requiring a veterinary feed directive or prescription for medically important antimicrobials used in animal feed or drinking water. GFI No. 213 also eliminated the use of medically important antimicrobials for animal growth promotion.

Products considered non-medically important in human medicine, such as ionophores used in feed, like monensin and lasalocid, are still available without veterinary oversight.

Currently, only 4% of medically important antimicrobials are marketed as OTC products for animals. This includes products for companion animals, horses and food animals. Once the recommendations in GFI No. 263 are fully implemented, all dosage forms of medically important antimicrobials approved for use in animals may only be administered under the supervision of a licensed veterinarian, and only when necessary for the treatment, control or prevention of specific diseases. Although animal owners will still have access to medically important antimicrobials, they will need to consult their veterinarian to obtain a prescription.

If a producer does not have an existing relationship with a veterinarian, it will be important to develop one in preparation for these changes. Successful treatment of disease and the appropriate use of antimicrobials work best when veterinarians and cattlemen work as a team. Developing this relationship provides the opportunity to strategically evaluate herd health protocols, animal welfare, biosecurity, management strategies and other operational activities. This relationship can result in economic savings, as well as enhanced protection of resources.

It is important to remember that a Veterinarian-Client-Patient Relationship is required before a veterinarian can legally write a prescription. Veterinarians can also guide producers on accurately meeting antimicrobial label requirements, including appropriate use and withdrawal. Additionally, treatment protocols and record-keeping measures can be developed if not already present in an operation.

Many stakeholders, including consumers, have an increased interest in the judicious use of antimicrobials. It is necessary for beef producers and veterinarians to work collaboratively to respond to changing guidance and requirements so that these medications are effective and available for years to come. Cattlemen and veterinarians working together can make an impact on decreasing the development of infectious agents with resistance. These efforts will contribute to improved medical outcomes to protect antimicrobial options for both animals and people.

For more information about GFI No. 263, visit the FDA website or contact the FDA’s Center for Veterinary Medicine at AskCVM@fda.hhs.gov or 240-402-7002.