Ag producers advised on impact of FDA rule on vaccine access; GFI263 goes in effect in June

Rowland summarized Guidance for Industry 263 (GFI263), regulations by the U.S. Food and Drug Administration (FDA) that affect certain medically important antimicrobial drugs from over-the-counter to prescription. Finalized in 2021, the change becomes effective this June where these drugs can only be used in animals under the supervision of a licensed veterinarian, even if the animals are not intended for food production.

According to the American Veterinary Medical Association, the same restrictions apply, from pet dogs and cats to backyard poultry, and from pet rabbits and pigs to large livestock farms. All these medically important antibiotics will require a prescription from a veterinarian to be used. Examples of affected products include injectable penicillin and oxytetracycline.

Voluntary guidelines have been in play with drug companies to change labeling for these drugs to be used under the advice of a physician. At the start of summer, the rule takes effect, which consumers will see — or rather not see — on store shelves.

"With this GFI263," Rowland said, such drugs as tetracycline, penicillin and sulfa pills, "you won't be able to walk into Primeland or North 40 after June and pick those up."

"When this started [in 2003], they started looking at the impact of antibodies use in animals and how this affects human health," Rowland said.

These drugs can be misused in ways, primarily in not following prescribed dosage application, whether in not using the full treatment or in overusing medication. In the first case, this can lead to some bacteria developing resistance, Rowland explained, and these are shed into the soil and transferred to other animals, ending up in the food source and in turn going to people.

"It's not necessarily the animals' problem, but they are the source of the potential problem," she said, "which is why the FDA is stepping in to combat this.

Overall, the larger concern is, "If we don't use these responsibly, we could have antimicrobial resistance, which is what everyone is worried about."

Rowland emphasized the need for vaccines.

"These work great to get the animal set up to fight disease," she said. "That's when the secondary bacteria come in and the virus decreases the immune system. Bacteria will make the animal sick and that's when we need to help the animal out to keep that animal alive long enough for its immune system to fight the disease."

However, "Antibodies are not the cure for everything," she continued. "We need to prevent the problem," through good management practices in areas that can be controlled, such as nutrition and stress. "And this is where we get into the vet-client relationship," she said, in looking at all these areas to help maintain and improve animal health.

Rowland clarified at the start of her presentation, "as scary as this sounds, it probably isn't going to affect you as much."Again, this goes back to establishing a good relationship with your veterinarian, she said.

"If you have that relationship with your vet, our access to these products doesn't change," added Meranda Small, U of I Extension Educator, Idaho County. What will change is access in the event of an emergency need after hours or on the weekend. She gave an example of one client who arranged with the vet to write out prescriptions for the entire calendar year for those products that may or may not be needed. "It's just taking steps ahead of time to be ready," she said.

For Rowland's practice, she noted that she doesn't expect to see a change. Apart from penicillin, which is on back-order, she keeps plenty of inventory on-hand due to how busy her business is.

Rowland said this regulation is a change producers can keep from going into further restrictions by treating animals as instructed: read the label.

"We're all in this business to produce healthy cattle," she said. "We want them to do well, we're living with them for calving day and night, we don't want to have them die. We want them to do well for the next guy."

GFI263 isn't there, "to make us more money," she continued. "They just made us a little more paperwork, but in a way, I'd rather be involved in seeing where the antibiotics are going. It's just there to help."

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Last week's presentation was one of two parts of the Beef School, the second set for today, Jan. 18, where Beef Quality Assurance (BQA) training and certification would be conducted.