What farmers need to know about FDA guidelines ending over-the-counter antibiotics

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From June 2023, farmers will no longer be able to buy over-the-counter antibiotics for their animals. It will be a big change for farmers, many of whom are used to doing much of their own veterinary care. Like it or not, farmers need to be prepared.

“The change is difficult for everyone, and it’s a huge change for commonly used medications that all livestock keepers and many small animals are used to being able to buy over-the-counter,” said Erika Alt, veterinarian at State Deputy for the West Virginia Department of Agriculture, during a West Virginia University extension webinar on March 22 explaining the Food and Drug Administration guidelines for Industry No. 263.

“Like the Veterinary Feed Directive, it will also take some time for everyone to come to terms with it and what this change really means.”

The new FDA guidelines recommend that manufacturers of “medically important antimicrobials” that are currently available over-the-counter label their drugs as prescription-only. The guidelines were finalized in June 2021 and will come into effect in June 2023 nationwide.

How will it work

This means that farmers need to have a veterinarian-client-patient relationship, or VCPR, in order to obtain antibiotics such as penicillin, oxytetracycline and erythromycin.

How VCPR is defined varied slightly from state to state, but that essentially means a veterinarian knows an animal and/or the operation well enough to diagnose and treat a medical condition, said Roselle Busch, extension specialist in sheep veterinary medicine. and goat at the University of California, during the webinar.

The veterinarian has assumed responsibility for making medical judgments for a breeder’s animals, the veterinarian will communicate those judgments to the client, and the client agrees to follow the veterinarian’s instructions, she said. The veterinarian should also be available for follow-ups in case of adverse reactions. Typically, this means that a producer has regular visits with the veterinarian for the care of their animals.

“Routine visits can mean something differentdifferent for different operations,” Busch said. “So defining what that might look like for you with your vet, every relationship will be different.”

In West Virginia, the VCPR requires a veterinarian to visit a farm at least once a year, Alt said. They don’t need to see all the animals on the farm, but enough to be able to make a medical judgment. That’s pretty typical of how the VCPR works in other states as well.

The new guidelines don’t require farmers to purchase antibiotics through their veterinarian, Alt said. People can use online pharmacies as long as they have a prescription.

The guidelines also don’t affect antiparasitic drugs, said Scott Bowdridge, associate professor of food animal production at West Virginia University. Although there is evidence of resistance in animals to some antiparasitics, the drugs used to treat parasites in animals are specific to agricultural species.

“So not the same worms, but they could be the same bacteria that are in animals that can be in humans,” he said.

Background

The guidance is part of an effort to combat antibiotic resistance, Busch said. An earlier industry guideline recommended that antibiotics given in feed or drinking water should only be obtained by prescription. The change was implemented in January 2017. This type of antibiotic represented about 95% of the market, while the remaining 5%, mainly injectable antibiotics, remained over the counter. Sales of food administered with antibiotics fall significantly after being made prescription-only, suggesting to the FDA that moving products under veterinary supervision has influenced judicious use.

Antibiotic regulation started in Sweden in 1986 when all growth-promoting antibiotics in animal feed were banned. The European Union followed suit in the 1990s and early 2000s, banning antibiotic food additives due to concerns about antibiotic resistance in humans.

“Whenever an antibiotic is used, regardless of indication, there is a risk of adverse effects or the development of antibiotic resistance,” Busch said. “Really, every time we use an antibiotic, we could potentially be promoting the development of resistance, which is why we want to eliminate the use of antibiotics when they’re not needed.”

On top of that, using antibiotics is expensive, “and nobody wants to just throw money away,” she said.

Examples

To see how it will work in the rest of the country, farmers can look to California, which manufactured all of the medically important antibiotics. available by prescription only as of 2018.

Busch, a California veterinarian and extension specialist, said California growers had the same concerns as many farmers here about animal health impacts and operating costs, but they adapted and many realized the value of working with a veterinarian.

Busch said that in some remote areas, veterinarians visit a farm every year to establish or maintain this VCPR. Then, the follow-up consultation is often done by telephone. A trip to the vet may still be necessary in an emergency, but even some of these situations can be planned ahead.

“Having these relationships in place before June 2023 can really help take away that worry that you can’t have antibiotics at home when pneumonia comes on, can’t it? You know how fast they go down,” Busch said. “So if you’re lambing or kidding and you have a protocol for pneumonia, that’s something you can work with your vet to have those meds on hand so you can treat the animal as soon as possible.”

Of course, none of this alleviates the shortage of large animal vets in rural areas, but it does give farmers time to prepare.

“Don’t wait until you have an emergency or really need some of these drugs,” Alt said.

Other resources:

Complete list of antibiotics affected by GFI 263

FDA GFI 263: Frequently Asked Questions for Farmers and Ranchers

Earlier farm and dairy coverage: FDA proposes animal antibiotics go behind the counter

(Reporter Rachel Wagoner can be reached at 800-837-3419 or [email protected])

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