In 2017 the U.S. Food and Drug Administration (FDA) began implementation of Guidance for the Industry #213, otherwise known as the Veterinary Feed Directive (VFD). The goal was to better regulate and control the use of medically important antibiotics in livestock use via feed and/or water. The industry adjusted to this new normal and life went on.
One area the VFD did not regulate were products that were available over-the-counter (OTC) by other dosage forms. To close this loop hole, the FDA published Guidance for the Industry #263 on June 11 of last year. This directive put in motion the framework to remove any remaining medically important antimicrobials from OTC marketing channels. Becky Funk, DVM with the Great Plain Veterinary Educational Center, and Jesse Fulton, Director of Nebraska Beef Quality Assurance share more.
Guidance #263 recommends sponsors of medically important antimicrobial drugs that continue to be available OTC and approved for use in animals (companion and food producing), regardless of delivery mechanism, 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."
While this change does not require the purchase of products from a veterinarian, going forward, producers will be legally required to obtain a prescription from a licensed veterinarian with which the producer has a valid veterinary-client-patient relationship (VCPR). What this means for many producers is that products that they may have purchased from the local feedstore, farm supply, or local co-op may no longer be on those store shelves.
Much like when the veterinary feed directive was put in place in 2017, some of these 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”. For those that do continue to stock these products on their shelves, producers will have to produce a prescription prior to purchasing.
The following are some products that will be seeing label changes to prescription-only status:
- Injectables: Liquamycin LA-200, Noromycin 300 LA, Bio-Mycin 200, Agrimycin 200, etc.
- Boluses: Terramycin Scours Tablets, OXY 500 Calf Boluses
- Penicillins (Penicillin G procaine, penicillin G benzathine)
- Injectables: Penicillin Injectable, Dura-Pen, Pro-Pen-G, Combi-Pen 48, etc.
- Intramammary tubes: Masti-Clear, Go-dry, Albadry Plus
- Sulfa-based antibiotics (Sulfadimethoxine, sulfamethazine)
- Injectables: Di-Methox 40%, SulfMed 40%
- Boluses: Albon, Sustain III Cattle & Calf Boluses, Supra Sulfa III Cattle & Calf Boluses
- Injectables: Tylan 50, Tylan 200
- Cephapirin, cephapirin benzathine
- Intramammary tubes: ToDAY and ToMORROW
Additionally, several swine medications fall under the new guidance:
- Injectables: Lincomix 100, Lincomix 300, LincoMed 100, LincoMed 300
- Injectables: Garasol, Gentamicin Piglet Injection
When Guidance #263 was published on June 11, 2021, it was structured with a two-year phase-in for manufacturers of these products to make label changes and come into compliance. This means all products covered under Guidance #263 are to be removed from OTC availability by June 11, 2023. The expectation is that producers will see familiar 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.
It is important to remember that these critical products are not being removed from the marketplace, but instead being brought under veterinary oversight in order to combat overuse/misuse due to OTC access. Furthermore, producers SHOULD NOT “stock-up” on these products to avoid needing a prescription once this change takes effect. Again, these products will STILL be readily available. Animal health products have expiration dates and are sensitive to storage time and conditions. Purchasing large quantities of animal health products may lead producers to have an excess of products unused by the date of the product’s expiration.
Now, more than ever, producers need to seek out and establish a VCPR with a trusted veterinarian to provide input on antibiotic selection for their operations so that the best treatment options can be selected with antibiotic stewardship, animal welfare, and livestock economics all important decision-making factors.
-Ben Beckman is a beef systems Extension Educator serving the counties of Antelope, Cedar, Knox, Madison and Pierce. He is based out of the Cedar County Extension office in Hartington. You can reach him by phone: (402) 254-6821 or email: email@example.com .