Written By: Rebekah Greene, Tattnall County Extension Agent, and Ross Greene, Evans\Candler County Extension Agent
On June 11, 2023, new guidance by the Food and Drug Administration will go into effect that will change the availability of many commonly used antibiotics for animals. The guidelines will apply to livestock producers, youth livestock exhibitors, home pet owners, dog breeders\kennels, and anyone who has previously purchased antibiotics Over The Counter to treat medical conditions in their animals.
The official title of the guidance is 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”.
This new guidance will require that many antibiotics currently available Over The Counter through suppliers such as Jeffers, Tractor Supply, local feed stores, etc. will now require a prescription from a licensed veterinarian. Some common antibiotics that will be regulated under this new guidance may include: Oxytetracyclines, Penicillin, Sulfa-based antibiotics, Tylosin, Cephapirin, Lincomycin, and Gentamicin.
The guidance does not require that the medications be purchased from a veterinarian. The animal owner will have to obtain a prescription prior to purchasing the medications. Due to the guidance, veterinarians will only be allowed to write a prescription to those with whom they have a VCPR. With this new guidance going into place, it will be highly important for livestock and pet owners to develop and maintain a Veterinarian Client Patient Relationship.
A Veterinarian Client Patient Relationship (VCPR) can be established through a variety of methods, including a farm visit, examining a sick animal, and\or an established knowledge of production practices. By working to establish a VCPR with your primary veterinarian now, the animal owners should not experience a lapse in their ability to access antibiotics and will be able to get prescriptions efficiently when these medications are needed.
There are also specifications on distribution of these medications that may cause many providers who sold the products as Over The Counter medications to no longer carry those medications. Suppliers may determine that the paperwork and records required are too cumbersome and choose to no longer stock these products. This means animal owners may need to plan farther in advance to order from an online pharmacy, order through their local veterinarian, or purchase through another approved provider who can accept their prescription for the medications.
While the guidance was officially approved in 2021, final implementation of the policies will go into effect in June. “Stocking up” on medicines while they are still available OTC is highly discouraged, as most drugs have specific expiration guidelines and storage requirements. Medications stored improperly or past the expiration date will be ineffective when used. Instead, local veterinarians are hoping to spread the word so that farmers who may not currently have an active VCPR will have an opportunity to establish one prior to the new guidance going into effect.
Animal owners should consider reaching out to their primary veterinarian for additional information and guidance to prepare for this change in distribution of these valuable medications. For additional resources and information, feel free to contact the local Extension Office for more information.
U. S. FDA Guidance Documents – 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 | FDA
FDA Regulation of Animal Drugs – FDA Regulation of Animal Drugs | FDA