A change in antibiotic access begins in June
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As of June 11, 2023, farmers, ranchers and others across the U.S. will no longer be able to buy antibiotics and other affected medications over-the-counter without a veterinarian’s prescription. Officially called the Food and Drug Administration’s Guidance for Industry #263 (GFI) it will seem like a new initiative, but actually it’s a piece of a much larger effort by the FDA that began a couple of years ago to help curb further development of antimicrobial resistance.
Most of the work went into communications with the drug distributors, who were responsible for changing labels.
It’s been a long time in coming, veterinary specialists say.
“We’ve been working hard for a year to make producers aware, with the over-riding goal, how we’re using drugs, especially medically important antibiotics in a sustainable way. The ones who will be taken by surprise may not have been as pro-active and not as actively communicating with their veterinarian,” said Dr. Becky Funk, veterinary extension specialist at the University of Nebraska-Lincoln.
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THE TRANSITION
As of June 11, instead of having antibiotics accessible to anybody coming in to purchase them, it will be under the oversight of a veterinarian who knows how to best use the antibiotics, Funk said. The products will still be available to treat animals with diseases, however producers will need to have a prescription from their veterinarian to purchase these products.
“The FDA has worked with pharmaceutical manufacturers to change their labels to indicate the prescription status, and these will begin rolling out on June 11, 2023. Existing inventory of these antibiotics that are already on shelves will be able to be sold as is, until those products’ expiration date,” said A.J. Tarpoff, DVM, associate professor, beef extension veterinarian, Kansas State University, Manhattan.
Cattle producers are not being singled out. This federal rule will pertain to all animals including cattle, horses, swine products, cats and dogs, small and exotic animals, any animals.
WHY THE CHANGE?
There’s concern that antibiotic resistance has increased, and that the resistance could possibly also cause human health problems, meaning that some bacterial resistance might be able to pass from cattle to humans on the farm.
“Not every pathogen is a concern, but some are very high on our concern list, if we generate a pathogen on a farm, like salmonella and e-coli (which we deal with commonly when baby calves have scours), and we do see those show up in human illness,” Funk said. Another one on her list for producers to watch for is cryptosporidium, sometimes informally called crypto.
Other livestock specialists have differing perspectives. “There’s word that companion animals and on-farm animals can translate resistance to humans. I don’t think it’s ever been proven,” said Gregg Hanzlicek, DVM, Ph.D., clinical associate professor, diagnostic medicine, College of Veterinary Medicine at Kansas State University in Manhattan.
Another veterinary specialist emphasizes that the forthcoming rule focuses on strengthening immunity, and avoiding bacterial resistance.
“The concern is not that antimicrobial resistant bacteria will be transmitted from livestock to humans, rather this is a stewardship initiative to ensure the long-term usefulness of these antibiotics into the future for both humans and animals. That is why it was decided to rely on the medical judgment of veterinarians to ensure the prudent use of these products,” Tarpoff said.
So as of June 11, nobody can go into a store and just get penicillin or oxytextracyclines. They can still use a mail order company, but it will require a veterinarian’s prescription, Hanzlicek said. Places will have to be designated as a pharmacy or farmers will need to get a prescription.
“The FDA reduced feed grade antibiotics by 30%, and we haven’t seen a health issue, so they want to reduce the use of injectibles, oral medicine, pour ons, any form of antibiotics,” Hanzlicek said.
Need a ‘VCPR’:
In the future, all prescription products, including all antibiotics will require the customer to have what’s called a Valid Veterinary Client Patient Relationship or VCPR.
They need to have a valid client/veterinarian relationship, and many already do. The veterinarian writes the prescription, and it’ll be valid for a year in Kansas (for six months in Nebraska), Hanzlicek said, adding, “It’s not that big a deal that it’s going to a prescription, you can get it from a veterinarian or a distributor. Just plan ahead. “It will mainly involve more paperwork, he said.
“It’s only for medicine that’s important to the human medical establishment, mainly all penicillins, and the tetracyclines because those are the ones used the most but also for cephalosporins and sulfas,” Hanzlicek said.
Specifically impacted are: LA 200 and 300, Noromycin, Vetramycin, Duramycin, Terramycin, Draxxin, Penicillin, Tylan, ToDay (a cephalosporin,) ToMorrow (cephapirin benzathine) and many other commonly used medications.
IMPACT
“Those producers who are already working with a veterinarian, probably won’t even realize the change is going to take place,” Funk said. It’s more so the others who may have been getting products over the counter and through mail order, she said. “I think this new rule will impact cow/calf producers more than feedlots simply because many of the feedlot producers may already be using products that require prescriptions and may already have that client/veterinarian relationship established,” said Galen Erickson, cattle industry professor of animal science and beef feedlot Extension specialist at the University of Nebraska-Lincoln.
“We don’t want them to go out and stock up. The products have expiration dates, which aren’t recommended for use after those dates, anyway. Also, these products are not going off the market,” Funk said.
Most cattle producers currently work with a veterinarian and have a well-defined Veterinary Client Patient Relationship (VCPR). This relationship legally allows veterinarians to prescribe prescription medications to producers for use in their animals, Tarpoff said. “For these producers, there will be no real impact of GFI 263. For those who don’t currently use a veterinarian routinely, now is a great time to create a VCPR with one, and utilize their local veterinarian’s expertise and guidance.”
For more information, contact Gregg Hanzlicek at Kansas State University at (785) 532-4853 or email him: gahanz@vet.k-state.edu. Or go to https://www.fda.gov/animal-veterinary/cvm-updates/fda-finalizes-guidance-bring-remaining-approved-over-counter-medically-important-antimicrobial-drugs.
