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Farmacy: Rx you ready for the new FDA rule?

Most over-the-counter livestock antibiotic medications will no longer be available for purchase without a veterinary prescription starting June 11.

This is the final phase of the Food and Drug Administration’s (FDA) Guidance for the Industry No. 263 on livestock antibiotic labels. Since 2017, the FDA has been trying to bring all approved livestock antibiotics under veterinary oversight. 

"This will end over-the-counter sales of antibiotics, and livestock owners will need a prescription from a veterinarian if they want to continue to have access," says Craig Payne, veterinarian, University of Missouri Extension. 

In January 2017, the FDA pulled approved feed antibiotics such as tetracycline and penicillin from retail farm and livestock supply store shelves and began requiring farmers to have a veterinary feed directive to buy the medications. In addition, the regulation included antibiotics that are delivered by water. 

"The public has an interest in what farmers are doing to care for livestock, and there's an expectation that we are going to use antibiotics judiciously with livestock," says Jennifer Roberts, a veterinarian with Boehringer Ingelheim. 

"As veterinarians, we want to make sure that we are judiciously using antibiotics, and this regulation allows us to have a little more input on the farm and to have conversations with farmers about following medication protocol," she says. 

The final phase of the regulation addresses several over-the-counter antibiotics and must display the following language on their RX labels: "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian." 

Most over-the-counter medication for any species of livestock, including cattle, will be affected by this new rule. For example, by June, dairy producers can no longer purchase the usually readily available cephapirin, cephapirin benzathine (ToDay and ToMORROW), penicillin G procaine, and penicillin G benzathine (Masti-Clear, Go-dry, Albadry Plus) intramammary tubes without a veterinary-client-patient relationship or prescription slip from their veterinarian.  

Chart of antibiotics affected.
University Missouri State Extension

However, there will be some exceptions for vaccines, dewormers, fly control, teat sealants, hormone implants or ionophores, and homeopathic medications. 

The new regulation will also exempt over-the-counter products purchased before the June date and will be honored as an over-the-counter medication until it expires, says Hayley Springer, a veterinarian for Penn State Extension. 

"This does play a part in patient use of antibiotics because it will allow farmers to communicate directly with their veterinarian when using those products, making sure they're using the correct dose and following the appropriate withdrawal time," says Roberts.  

If a producer doesn’t have a veterinary-client-patient relationship with a local veterinarian, they need to establish one. 

This means farmers will have to find a veterinarian that is willing to become familiar with their farm and style of animal care by either one examination or timely visits to the farm. 

Producers should check the requirements in their state, as some areas have stricter guidelines. For example, South Carolina nullifies a farm's veterinary-client-patient relationship if a veterinarian has not seen the farm within one year, says the American Veterinary Medical Association. 

Springer suggests farmers lacking a veterinarian should start by calling their area veterinary services to learn the requirements for establishing and maintaining an excellent veterinary-client-patient relationship. 

On the Storefront

Businesses that sell, dispense, or fill orders for animal prescription drugs must have a state pharmacy permit and comply with the rules associated with holding that permit. Because of this, most brick-and-mortar farm stores might decide not to sell antibiotics once FDA requires a prescription, says Payne. 

Most online pharmacies that handle interstate business follow federal and state requirements when distributing, dispensing, or delivering prescription drugs. In addition, many of the popular online vendors currently sell prescription drugs and are already compliant with these requirements.

"After the June date, the antibiotics will still be available, but farmers will need to communicate with their veterinarian and make sure they have those prescriptions on file to purchase the medications they need," says Roberts.

This change from the FDA can be an opportunity for most farmers to take a closer look at their animal health management. One management goal should be prevention, says Roberts.  

"Make sure your housing is appropriate and has good ventilation. And ensure you're providing good nutrition to support the immune system and a strong vaccination protocol — all of those contribute to disease prevention," Roberts says. "That's essential when we, as veterinarians, are prescribing or choosing an antibiotic for an infection. We want to make sure we recommend the right regimen." 

Roberts believes the FDA's final phase is a positive change for the livestock health industry. However, she acknowledges it's a change for most farmers that have valued the convenience of purchasing antibiotics whenever the need arises on their farms. 

"It's a change, but I think farmers will get used to it. For those that have a relationship with a veterinarian, it's going to be an effortless change. For farmers that need to establish a relationship with a veterinarian, it's going to be a positive experience," she says. 

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