Changes are around the corner for producers trying to obtain medically important antimicrobials. Michele Barrett, a technical service veterinarian and medical lead with Zoetis, shares with Editor Cassidy Woolsey what these changes mean and how producers can prepare for them.
Q. What is GFI No. 263 and why is the FDA issuing this guidance?
A: In 2021, the U.S. Food and Drug Administration (FDA) announced Guidance for Industry (GFI) No. 263, which completes the last phase of the transition of all medically important antimicrobials from over-the-counter (OTC) status to requiring veterinary prescription (Rx). Making this transition will ensure the remaining 4% of medically important antimicrobials currently available OTC are used under a licensed veterinarian’s supervision starting by June 2023.
This guidance builds on steps already taken by the Center for Veterinary Medicine (CVM) to support the stewardship of antimicrobials that are medically important for humans and also used in animals. It’s part of the FDA’s five-year action plan to ensure these drugs are used judiciously and reinforces the need for veterinarians and producers to work together on protocols that ensure these products are used appropriately — and only when necessary.
Q. What products will this include?
A: There are 91 animal health product applications affected by this change, manufactured by many companies.
Zoetis has six commercially available products that will change from OTC to Rx to comply with the new guidance from the FDA:
- Albadry Plus suspension (cattle)
- Albon boluses (cattle)
- Lincomix injectable (swine)
- Liquamycin LA-200 (cattle, swine)
- Terramycin ophthalmic ointment (dogs, cats, sheep, cattle, horses)
- Terramycin scours tablets (cattle)
The full list of product applications and manufacturers from the FDA can be found at their website.
Q. How will a producer obtain the products after June 11? Will any farm stores continue to carry these products?
A: After June 11, 2023, when the transition has taken place, producers will need a prescription from a licensed veterinarian to purchase the products listed by the FDA. This means the products will no longer be available for purchase from a retailer via e-commerce or at a brick-and-mortar retailer without a prescription from a veterinarian.
Once a producer has a veterinarian prescription, they do have options to purchase through these channels:
- Veterinarian: Buy directly from a veterinarian and pick up at a veterinary office
- Retailer: Buy from e-commerce or a brick-and-mortar retailer that fills prescriptions with a veterinarian
- Distributor: Obtain a veterinary prescription and get delivered or shipped from a distributor partner
Q. Why would a producer need to consult a veterinarian to get the same drugs they have always used? What if a producer currently doesn’t have a relationship with a veterinarian?
A: A veterinarian has specialized training in disease prevention and treatment and provides insights and knowledge that are key to keeping your animals healthy. Now more than ever, it is critical to ensure a veterinarian-client-patient relationship (VCPR) is in place and you revisit treatment protocols addressing the disease issues specific to your animals. You can work with your local veterinarian to establish a VCPR and to identify management strategies for your operation, including issuing prescriptions as needed.
If you don’t currently have a veterinarian, resources like state veterinary associations, state cattlemen associations, and even friends and neighbors can help identify one.
Q. Will a veterinarian be required to physically examine each animal before writing a prescription? Can you give an example of a situation a producer may come across?
A: Once a VCPR is in place, veterinarians generally do not have to be present for individual treatments in most states. I suggest establishing that veterinarian relationship now and planning for the year ahead. As part of the VCPR conversation, you and your veterinarian should discuss common diseases found on your operation, how to identify them early and what treatment protocols your veterinarian recommends for those specific diseases. This will help with discussions when a sick animal is identified in the future and is key to making sure you can successfully treat disease and access products you may need.
For example, if you need to treat a case of foot rot and already have a VCPR established, you can call your veterinarian and talk through the symptoms and diagnosis. Based on your veterinarian’s assessment of the case, they can then prescribe an appropriate antibiotic if needed. You can coordinate with the veterinarian for a pickup or use the prescription to buy from an online vendor or distributor with a pharmacy license.
Q. What steps can be taken now to help producers when these rules come into effect?
A: I strongly encourage producers to talk with their veterinarian to avoid surprises about where and how they can access animal health products. Now is the time to establish or reestablish a VCPR so you have a plan.
Q. Do you have anything else that should be addressed? Any other questions producers have been asking?
A: Spring vaccination season is a great opportunity to have conversations with your veterinarian about how to appropriately identify disease and what treatments would be best for your specific disease pressures. Prevention is key and is the first step in animal care conversations about antibiotics. Think more proactively and less reactively by having a robust conversation with your veterinarian to make a tailored plan for your operation.
