FAQ: Understanding GFI 263

As of June 11, 2023, 91 livestock antibiotics previously available over the counter now require a prescription from a veterinarian, as part of U.S. Food and Drug Administration (FDA) Guidance for Industry (GFI) No. 263.

Learn more with this insight from Lacey Fahrmeier, DVM, Technical Service Veterinarian at Valley Vet Supply, as well as information from FDA.gov, about GFI 263 and cattle antibiotics that will now require a prescription. Are you aware of the changes implemented to ensure your herd’s health?

Q: First, what is GFI 263?

“The US Food and Drug Administration has released this antibiotic guidance pertaining to medically important antibiotics used in food animals that are currently approved for over-the-counter purchase,” Dr. Fahrmeier said.

“Under the new guidelines, several antibiotics that producers are familiar with would no longer be available over the counter and must be prescribed by a veterinarian. In general, GFI 263 is affecting the injectable over-the-counter antibiotics that livestock producers typically use -- those being Gentamicin, Lincomycin, Oxytetracycline and Penicillin, as well as the oral drugs like Sulfamethazine and Tylosin. One of the misconceptions is that producers will have to buy this straight from the veterinarian -- they won't have to buy these antibiotics from their veterinarian, but they will need a valid-client-patient relationship with a veterinarian and prescription to purchase them.

The intent of this guidance is to keep a better inventory of antibiotics and also try to maintain those antibiotics that are important for human medicine use from being used incorrectly and developing resistance. I feel like this is the main thrust of the guideline.”

Q: How can cattle producers prepare now for GFI 263 to ensure their herd’s health is not impacted and they have cattle medicine available?

“I would encourage producers to establish a client patient relationship with a veterinarian, so that they are there to assist and guide you when needed. Working with your veterinarian to develop a herd health plan, including vaccine and treatment protocols for common diseases in your area, is essential to keeping your herd performing at a high level and minimizing disease.

It is also a good idea to have a basic pharmacy already in place and know how to appropriately utilize those medications when disease or injury does arise,” said Dr. Fahrmeier.

Q: Why is the FDA issuing this guidance?

According to FDA.gov, “Guidance for industry (GFI) #263 is part of a broader effort by FDA to combat antimicrobial resistance (AMR), a serious threat to animal and public health. Antimicrobial use in humans, animals, and horticulture can contribute to the development of AMR. Using antimicrobials judiciously, in all settings, can help slow the rate at which AMR develops.”

Q: Why must producers acquire a prescription on previously approved over-the-counter medications?

According to FDA.gov, “Obtaining these drugs under a veterinarian’s supervision can help guide the judicious use of antimicrobials and slow the development of AMR because veterinarians have specialized training and experience. Sometimes antimicrobial drugs may not be necessary for proper treatment or a different antimicrobial may be a better tool than the one you’re used to using. Providing animals with the most appropriate antimicrobial is more likely to effectively resolve the infection and reduce the need for repeated or extended courses of antimicrobial therapy. This will not only help to reduce AMR risks but will help to ensure better health outcomes for animals and can also save time and money.”

Q: How can cattle producers continue to get access to the cattle medicine they need?

According to FDA.gov, "Farmers and ranchers would still have access to appropriate antimicrobials to address animal health issues by consulting with a licensed veterinarian with whom they have established a valid veterinarian-client-patient relationship (VCPR).

Just because a drug is prescription status does not necessarily mean you are required to purchase it directly from a veterinarian; you may be able to purchase prescription animal drug products from various suppliers or distributors with a valid prescription provided by a licensed veterinarian.”

Q: Is a farm visit and exam of each animal required before obtaining a prescription?

“Veterinarians are generally not required to examine each individual animal for which a prescription is issued, as long as the veterinarian has established a valid VCPR with the farmer or rancher that owns or cares for the animal(s) in need of treatment. Establishing a VCPR generally requires, among other things, that the veterinarian has become familiar with the management of the animals on a given farm or ranch by examining the animals and/or visiting the facility where the animals are managed,” according to FDA.gov.

Dr. Fahrmeier says, “Having a vet come out onto your farm, boots on the ground, I think is key so that you can get the most out of the relationship and they can offer you the best possible advice.”

Q: As a veterinarian and cattlewoman yourself, what does GFI 263 mean to you, and to our industry?

“I guess I look at it as a way to actually preserve the ability to utilize these important antibiotics in food animal medicine, because the last thing that I want to see happen are mandates or stipulations where there are certain antimicrobials that are deemed unavailable for use in food animal medicine. It would be devastating to not have the tools needed to help the animals that we're all trying to protect and treat.

Granted there will be a little bit more oversight, and there will be some inconvenience in attaining that prescription, but I feel like it's a better alternative than not having access to the vital tools we need to treat animals. I think that the alternative of still having access to these tools far outweighs any downside as far as convenience goes,” Dr. Fahrmeier said.

Speak with your veterinarian, or call 800-419-9524 and request to speak with one of our Valley Vet Supply Technical Service veterinarians, to learn more about GFI 263.

View cattle antibiotics and more to ensure your herd’s health. We’re here to help you and your veterinarian navigate swift prescriptions fulfilled, fast shipping and general information, with our fully staffed pharmacy and Technical Service veterinary team just a phone call away.

SUMMARY:

The U.S. Food and Drug Administration (FDA) Guidance for Industry (GFI) No. 263 went into effect in June 2023. As part of the new Guidance, several antibiotics that producers are familiar with -- previously available over the counter -- will require a prescription from a veterinarian. Placing orders for prescription medications through Valley Vet Supply is simple. Prescriptions from your veterinarian can be received through four convenient methods: By our pharmacy contacting your veterinarian, by fax or phone from your veterinarian, or by mail.