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Over-The-Counter Antibiotics to Transition to Prescription Status


In September of 2019, the FDA Center for Veterinary Medicine (CVM) released a draft of guidance for industry (GFI) #263. The goal of this document is to encourage makers of animal drugs to voluntarily withdraw all over-the-counter antibiotics used in food-producing animals, and transition these drugs to prescription status. This will mean that some injectable and oral antibiotics that have traditionally been available for purchase at feed supply stores will only be available through a veterinarian, or with a veterinary prescription.

The FDA considers this action an important step in minimizing the development of further antibiotic resistance. The CDC estimates that, in humans, almost 3 million infections and over 35,000 deaths were the result of infections caused by antibiotic resistant bacteria last year.


Though the problem of antimicrobial resistance is complex and has many underlying causes, the livestock industry is shouldering a significant load in doing their part to combat the problem. The FDA reports that sales and distribution of antibiotics intended for use in food producing animals has dropped by over 40% since 2015. A great deal of this decline came between 2016 and 2017 and was due to the implementation of GFI #213. You may recall that this guidance removed growth promotion claims from all antibiotics used in animal feeds, and required a veterinary feed directive (VFD) or prescription for antibiotics used in livestock feed or water.


The FDA is allowing sponsors 2 years to adapt, once the final guidance document is in place. Realistically, this means that the changes will be put into practice sometime in 2022 or 2023.


It is a good idea to talk about the coming changes with your veterinarian and understand if, and how, this may impact your operation. If you do not have a routine relationship with a veterinarian, then consider establishing one. Veterinarians are legally required to have a veterinary-client-patient-relationship (VCPR) in place to be able to prescribe medications for your animals. In short, this means that they know you and your operation well enough to be comfortable taking responsibility for the antibiotics used on your farm. They should have sufficient working knowledge of your on-farm practices to make a preliminary judgment about how to best treat diseases your livestock may encounter, and should be available for follow up, should there be treatment failure. Most veterinarians will be eager to help you achieve your goals, but would ask that you do not put them in an awkward position by asking them to dispense prescription medications without a VCPR in place. Establishing working relationships now will eliminate the need for “emergency” establishment of a VCPR should you have urgent need of a prescription in the future.


In many instances, little will change about how you treat certain conditions, while in others, new or different treatment protocols may be recommended. Though change is often challenging, looking at this change as an opportunity to learn something new, rather than as an undue burden, may make the situation more palatable for all involved. Significant knowledge has been gained in the last decade, and advances in technology have provided many new tools for disease treatment and prevention. Consider not only alternative strategies for treatment of common diseases, but also keep an open mind about strategies for disease prevention. Working together, producers and veterinarians can reduce unnecessary antibiotic usage, while maintaining top-notch animal health.

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