The FDA set to require prescriptions for remaining OTC antibiotics
The FDA Sets to Require Prescriptions for Remaining OTC Antibiotics
The U.S. government recently announced the final wave of guidance in its move to require livestock producers to obtain prescriptions for antibiotics used to treat their animals. The Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) has released the list of the remaining OTC (over-the-counter) antibiotics that will need a prescription starting next year.
The transition of antibiotics from OTC to Rx (prescription) has been ongoing for several years and is set to be completed by June of 2023. However, exactly when producers will feel the direct impact of the latest part of the initiative is still unknown. “What is uncertain at this time is when we will see the changes first appear in the marketplace,” Craig Payne, DVM, extension veterinarian with the University of Missouri, explained.
Why the Transition from OTC to Rx
According to the FDA-CVM, the purpose of bringing medically important antimicrobials under veterinary supervision is to guide the judicious use of antimicrobials and slow the development of antimicrobial resistance. The multi-year plan includes steps to address the challenge of bacteria becoming resistant to antimicrobials and to monitor the effectiveness of antimicrobials.
Over the past couple of years, most antibiotics used to treat livestock have moved under the jurisdiction of veterinarians. In the final step of the process, injectable antibiotics along with some intramammary tubes and boluses will no longer be available without a prescription. These changes are set to take place in 2023.
How to Prepare for the Changes
Most producers have been witnessing the changes as the federal government has rolled out its plan through the years. But now the initiative is in its final stages.
If they haven’t already, producers need to prepare for changes. “Considering this will end over-the-counter sale of antibiotics, producers will need a veterinarian-client-patient-relationship (VCPR) with a veterinarian to ensure they have continued access to antibiotics in the future,” Payne said.
According to Dr. Payne, a VCPR means a veterinarian is familiar with the care and keeping of animals on an operation. If producers have further questions about what a VCPR entails, they should contact a local veterinarian.
Cost to Producers
Whether this will impact a producers’ pocketbook depends on the current status of their VCPR. If producers have not yet established a VCPR, there will be some additional costs associated with that process. A local veterinarian can walk producers through the details of a VCPR and the cost of setting it up.
Producers Impacted by the Plan
According to Dr. Payne, the changes should have little impact on producers who currently have a VCPR established with a veterinarian. Their veterinarian will be able to issue a prescription for antibiotics if the need arises. “On the other hand, if a VCPR is non-existent or you’re unsure what is required, now is the time to find a veterinarian willing to work with your operation so you will continue to have access to antibiotics in the future,” Payne stated.