FDA announces change in animal antimicrobial drugs' status
Posted on Jun 20, 2023 at 20:00 PM
On June 12, the U.S. Food and Drug Administration (FDA) implemented its previously announced decision that certain antibiotics once available over the counter have been placed under veterinary oversight.
For a list of frequently asked questions about the updated status, click here.
FDA indicated that all affected animal drug sponsors opted to either voluntarily change the approved marketing status of certain medically important antibiotics for animals from over-the-counter (OTC) to prescription (Rx) or to voluntarily withdraw approval of their affected OTC animal drug applications. As a result, all affected products that enter the marketplace will now have prescription labels.
Once remaining inventory of OTC-labeled products depletes, all medically important antibiotics for animals will require the authorization of a licensed veterinarian.
Animal owners and caretakers will still have access to appropriate antimicrobials to address animal health issues by consulting with a licensed veterinarian. Specific requirements related to prescription animal drugs vary by state, including those related to the establishment of a valid veterinarian-client-patient relationship (VCPR).
Georgia livestock producers can locate a food-animal veterinarian via the Georgia Veterinary Medical Association’s “Vet Locator” feature on GVMA website. To access the vet locator, visit www.gvma.net, click on the Resources tab at top of the page, select “Online Directory”. Then click the “Find a Vet” tab and enter your location and the type of services you are looking for.