By DOUG SCHMITZ
AMES, Iowa – The FDA has announced new restrictions on the use of livestock antibiotics (Guidance for Industry 263) and implant labeling (Guidance for Industry 191) for U.S. cattle producers, effective June 11.
Guidance for Industry 263, which are medically-important livestock antibiotics that have been available over-the-counter will only be available through prescription by a licensed veterinarian, while Guidance for Industry 191 will change how steroid-based implant labeling is used.
For Guidance for Industry 263 (livestock antibiotics use), Grant Dewell, DVM, Iowa State University associate professor of veterinary medicine, however, said “there really isn’t anything new moving from over-the-counter to prescription status.”
“Most producers are already familiar with prescription drugs as most medications are only available this way anyway, so no big change besides some paperwork,” he said. “The major change will be where producers can buy these products as getting them over-the-counter at a farm supply store will no longer be an option.
“They will now have to buy directly from their veterinarian, or have their veterinarian write them a prescription so that they can purchase from another entity such as an online pharmacy, or drug distributor,” he added.
But he said he doesn’t foresee Guidance for Industry 263 having much impact on U.S. beef producers.
“In 2017, the move from over-the-counter to veterinary feed directive (a drug intended for use in animal feeds) status for many of our feed antibiotics was challenging, but that was because we were essentially having to adapt to a new system for veterinarians, feed distributors, and producers.
“There was some uncertainty about the new labels: how veterinarians and feed distributors would be able to implement the new system, etc.,” he added. “It was implemented fairly quietly and most people active in this area knew it was coming since the FDA published their five-year plan in 2018. After all, we went through with the veterinary feed directive rule. This seems to be a minor issue.”
For Guidance for Industry 191 (implant labeling use), he said the rule will limit the ability to re-implant cattle without specific label approval when they are in the same production setting.
“This will force some change in how we look at implanting cattle, but there are still options,” he said. “We have some extended-release implant products that were already the equivalent of a two-implant system.
“The FDA is not saying that we can’t re-implant cattle – there are some labels that clearly state re-implant protocols – just that in order to re-implant, the label has to clarify how implants are to be aligned,” he added.
He said, “Guidance for Industry 191 is designed to clarify how supplemental labels of drugs are done, so I am expecting to see some new labels in the not-so-distant future that will actually specify re-implant options for producers.”
Andrew P. Griffith, University of Tennessee associate professor of agricultural and resource economics, who specializes in cattle markets, agreed with Dewell, saying, “Many of the large producers already work with a veterinarian or employ one, so it has little to no impact on them.
“I doubt the implant issue will impact many people,” he said.” Very few cow-calf producers are utilizing the technology, and those who do utilize implants can craft a program that fits their needs.”
He said, “The biggest issue for most producers will be needing a veterinary-client relationship to purchase the few antibiotics that are still over-the-counter. This may result in a small cost to them, but many in the veterinary retail space have begun to employ a veterinarian. This likely increases the cost of most veterinarian items.”
Dewell said, “Producers and veterinarians need to work together to operate in today’s agriculture climate There are many differing external pressures on livestock production that we need to be working together on to maintain our chosen professions.”
Debbie Reed, DVM, Murray State University associate professor of veterinary medicine and director of the university’s Breathitt Veterinary Center in Hopkinsville, Ky., said, “By reaching out to bovine veterinarians now, beef cattle farmers can prevent train wrecks when new laws take effect.”
“Just as a good farmer won’t wait until August to begin finding hay, don’t wait until the last minute to secure veterinary care,” she said. “By talking to other beef farmers, local extension personnel and cattlemen’s groups, beef farmers can get an idea of where veterinary care can be found. Perhaps coalitions can be built to recruit food animal veterinarians to the region.”
Dewell also recommended producers discuss with their veterinarian what other therapies may be available.
“If you have been getting by with oxytetracycline (a broad-spectrum antibiotic, frequently used in veterinary medicine for gastrointestinal and respiratory system diseases) because that is what you have and you didn’t want to deal with getting a prescription drug, now there may be some better options for you that could improve your treatment success and the welfare of your animals.”
Reed said while this new FDA legislation has undoubtedly caused concern for some farmers, the vast majority of farmers will ultimately gain better care for their livestock following consultation with a veterinarian.