What farmers need to know about FDA guidance ending OTC antibiotics

7
59008
white and orange syringe on white surface

Beginning in June 2023, farmers won’t be able to buy any over-the-counter antibiotics for their animals. This will be a big change for farmers, many of whom are accustomed to doing much of their own veterinary care. Like it or not, farmers need to be prepared.

“Change is hard for everyone, and this is a huge change for those commonly used drugs that every livestock producer and a lot of small animals folks are used to being able to purchase over the counter,” said Erika Alt, assistant state veterinarian for the West Virginia Department of Agriculture, during a March 22 West Virginia University Extension webinar explaining the Food and Drug Administration’s Guidance for Industry No. 263.

“Just like the veterinary feed directive, this too is going to take a little while for everyone to come to terms with it and what that change really means.”

The new FDA guidance recommends manufacturers of “medically important antimicrobials” that are currently available over-the-counter label their drugs available by prescription only. The guidance was finalized in June 2021 and will take effect in June 2023 nationwide.

How it will work

That means farmers will need to have a veterinary-client-patient relationship, or VCPR, in order to get antibiotics like penicillin, oxytetracycline and erythromycin.

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

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

“Routine visits might mean something different for different operation,” Busch said. “So, defining what that might look like for you with your veterinarian, every relationship’s going to 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 every animal on the farm, but enough to be able to make a medical judgment. That’s pretty typical of how VCPR’s work in other states as well.

The new guidance does not require farmers to purchase antibiotics through their veterinarian, Alt said. People can use online pharmacies as long as they have a prescription.

The guidance also does not affect anti-parasitic drugs, said Scott Bowdridge, associate professor of food animal production at West Virginia University. Though there is evidence of resistance in animals to certain anti-parasitics, 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 people,” he said.

Background

The guidance is part of an effort to combat antibiotic resistance, Busch said. An earlier guidance for industry recommended antibiotics administered in feed or drinking water be made prescription only. The change was implemented in January 2017. That type of antibiotic represented about 95% of the market, while the other 5%, mostly injectable antibiotics, stayed over-the-counter. Sales of the feed administered antibiotics dropped significantly after being made prescription-only, suggesting to the FDA that moving the products under veterinary oversight influenced judicious use. 

Regulations around antibiotics began in Sweden in 1986 when all growth-promoting antibiotics in animal feed were banned. The European Union followed suit in the ’90s and early ’00s, banning antibiotic feed additives over concerns about antibiotic resistance in humans.

“Any time an antibiotic is used, regardless of the indication, there is potential for either adverse effects or development of antibiotic resistance,” Busch said. “Truly, any time we use an antibiotic, we could potentially promote 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 costly, “and no one wants to just throw money down the drain,” she said.

Examples

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

Busch, a California vet and extension specialist, said California producers had the same concerns many farmers here have about impacts to animal health and operating costs, but they’ve adapted and many have realized the value of working with a veterinarian. 

Busch said in some remote areas, veterinarians make an annual trip to a farm to establish or maintain that VCPR. Then follow-up consulting is often done over the phone. A veterinarian visit may still be needed for emergencies, but even some of those situations can be planned for ahead of time.

“Having those relationships in place before June 2023 can really help eliminate that concern that you can’t have antibiotics on your place when a pneumonia pops up, right? You know how quickly they go downhill,” Busch said. “So, if you’re lambing or kidding and you have a protocol for pneumonia, that’s something you can work out with your veterinarian for having those drugs on hand so you can treat the animal as soon as possible.”

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

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

Further resources:

Full list of antibiotics affected by GFI 263

FDA’s GFI 263: Frequently Asked Questions for Farmers and Ranchers

Past Farm and Dairy coverage: FDA proposes animal antibiotics go behind the counter

(Reporter Rachel Wagoner can be contacted at 800-837-3419 or rachel@farmanddairy.com.)

STAY INFORMED. SIGN UP!

Up-to-date agriculture news in your inbox!

SHARE
Previous articleRed Beard Bees
Next articleSelecting the right plants for wet land in Ohio
Rachel is a reporter with Farm and Dairy and a graduate of Clarion University of Pennsylvania. She married a fourth-generation beef and sheep farmer and settled down in her hometown in Beaver County. Before coming to Farm and Dairy, she worked at several daily and weekly newspapers throughout Western Pennsylvania covering everything from education and community news to police and courts.

7 COMMENTS

  1. what a load of BS this is just vets trying to get richer and take away our freedom to raise our own food. The food already cost to much for most people now

  2. This is exactly what we need… More government oversight, or people that have no idea what they are talking about deciding how I should raise my animals. Forcing me to shell out more thousands to a veterinarian just to get simple medications is ridiculous. Can’t wait to hear about the ban of all OTC meds for humans too.

  3. There are no large animal vets who will come to our farm, they are not taking new patients. We are in a very rural
    area and have to handle our own emergencies. We recent lost a cow after she calved and we couldn’t get anyone to come and help. The fact we will have to rely on a vet we don’t have, for medication, just makes it harder.

  4. Lovely, trying to find a vet who sees goats is almost impossible and if you do they are not taking on any new clients because they are overwhelmed. Let farmers alone the government in nevera help except for themselves

  5. Ignorant and a direct threat to the goat breeders. Long time goat breeders know far more about goats than vets who do not specialize in goats. FAR MORE.

  6. The only way this will stop in medicine (for our animals and us) is when the medical providers stop listening and being bought out. The good ones leave, see if you can find them, they don’t want to leave but they can’t “comply” with this garbage. You can figure out the rest of the plan from that. Stand up! Find your work around now, it will depend more on you than ever before. We can do this!

LEAVE A REPLY

We are glad you have chosen to leave a comment. Please keep in mind that comments are moderated according to our comment policy.

Receive emails as this discussion progresses.