Are You Ready for the Next Phase? Prescription-Only Antibiotics

Are you ready for the next Phase? Prescription-Only Antibiotics

by Dr. Teresa L. Steckler, University of Illinois Extension

Veterinary Feed Directive, or more commonly known as VFD - I think almost everyone has heard that acronym! Several years back that acronym caused much consternation for producers and veterinarians alike. Are you ready for the next phase?

The background is the following: in 2017 the Food and Drug Administration (FDA) began implementing the Guidance for the Industry #213 (also known as VFD). Implementation of the VFD focused on veterinary oversight of medically important antibiotics delivered to livestock via feed and/or water. A significant loophole for products that were available over-the-counter (OTC) was made. Because of this loophole, on June 11, 2021, the FDA quietly published Guidance for Industry #263 which put in motion the framework to remove any remaining medically important antimicrobials from OTC marketing channels, thus closing this loophole.

Guidance #263 “recommends” producers of medically important antimicrobial drugs that continued to be available OTC and approved for use in animals (companion and food producing), regardless of method of delivery, to voluntarily bring these products under veterinary oversight or prescription marketing status. These product labels will now contain the prescription (Rx) statement, “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

Even though very little information about Guidance #263 was aimed towards livestock producers, the rule may significantly impact the way in which livestock owners are able to access/secure antibiotic therapy for their livestock. While this change does not require the purchase of products from a veterinarian, producers will be legally required to obtain a prescription from a licensed veterinarian. However, the producer must have a valid veterinary-client-patient relationship (VCPR). Thus, producers may no longer be able to purchase from their local feedstore, farm supply, or local co-op; availability will be on a store-to-store basis.

Much like when the veterinary feed directive was put in place in 2017, some businesses may simply pull these products from store shelves and decline to offer products as they do not have the framework in place to meet the legal burden of acting as a “pharmacy” which requires the ability to review veterinary authorized prescriptions and track refills of those prescription products. For those that do continue to stock these products on their shelves, producers will have to secure a prescription prior to purchasing.

Those producers who already have a VCPR in place and purchase their animal health products through their veterinarian, or who purchase through other distributors under an existing prescription system, will likely notice little change in their ability to source these products. The biggest change will be for those producers that do not consult a

veterinarian on a regular basis. They will need to establish a valid VCPR prior to purchasing these products as they start to disappear from OTC access.

So, in Illinois the legislation that defines the veterinaryclient-patient relationship can be located at https://www.ilga. gov/legislation/ilcs/ilcs3.asp?ActID=1326&ChapterID=24. The legislation is called PROFESSIONS, OCCUPATIONS, AND BUSINESS OPERATIONS (225 ILCS 115/) Veterinary Medicine and Surgery Practice Act of 2004.

This legislation is the following (taken directly from the website): “Veterinarian-client-patient relationship” means that all of the following conditions have been met: 1. The veterinarian has assumed the responsibility for making clinical judgments regarding the health of an animal and the need for medical treatment and the client, owner, or other caretaker has agreed to follow the instructions of the veterinarian; 2. There is sufficient knowledge of an animal by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal. This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal by virtue of an examination of the animal or by medically appropriate and timely visits to the premises where the animal is kept, or the veterinarian has access to the animal patient’s records and has been designated by the veterinarian with the prior relationship to provide reasonable and appropriate medical care if he or she is unavailable; and 3. The practicing veterinarian is readily available for follow-up in case of adverse reactions or failure of the treatment regimen or, if unavailable, has designated another available veterinarian who has access to the animal patient’s records to provide reasonable and appropriate medical care.

“Veterinarian-client-patient relationship” does not mean a relationship solely based on telephonic or other electronic communications.

The following are some products that will be seeing label changes to prescription-only status: • Oxytetracyclines o Injectables: Liquamycin LA-200, Noromycin 300 LA, Bio-Mycin 200, Agrimycin 200, etc. o Boluses: Terramycin Scours Tablets, OXY 500 Calf Boluses • Penicillins (Penicillin G procaine, penicillin G benzathine) o Injectables: Penicillin Injectable, Dura-Pen, Pro Pen-G, Combi-Pen 48, etc. o Intramammary tubes: Masti-Clear, Go-dry, Albadry Plus • Sulfa-based antibiotics (Sulfadimethoxine, sulfamethazine) o Injectables: Di-Methox 40%, SulfMed 40% o Boluses: Albon, Sustain III Cattle & Calf Boluses, Supra Sulfa III Cattle & Calf Boluses • Tylosin o Injectables: Tylan 50, Tylan 200 • Cephapirin, cephapirin benzathine o Intramammary tubes: ToDAY and ToMORROW

Additionally, several swine medications fall under the new guidance: • Lincomycin o Injectables: Lincomix 100, Lincomix 300, LincoMed 100, LincoMed 300 • Gentamicin • Injectables: Garasol, Gentamicin Piglet Injection

So, when will these changes take effect? All products covered under Guidance #263 are to be removed from OTC availability by June 11, 2023. The expectation is that producers will see products start to disappear from store shelves as OTC products over the next 14 months as manufacturers finalize label changes and refine their marketing and distribution channels to assure compliance with prescription requirements. If you do not have a VCPR, now is the time to find and develop that relationship.