Plan now for antibiotic changes on horizon

COLUMBIA, Mo. – While 2023 might seem a long way off, it’s not too early for livestock producers think about how recent Food and Drug Administration guidance might affect their operations, says University of Missouri Extension veterinarian Craig Payne.

On June 11, the FDA’s Center for Veterinary Medicine published Guidance for Industry No. 263 (GFI #263) in the Federal Register. The document outlines a strategy and timeline for bringing all medically important antibiotics that are currently available over the counter under veterinary oversight. This will affect several antibiotics familiar to livestock producers.

If you have a valid veterinarian-client-patient relationship, the impact will be minimal because a veterinarian will be able to issue a prescription for these antibiotics, says Payne. If you don’t have a VCPR, now is the time to find a veterinarian willing to work with you to ensure future access to antibiotics.

Under a VCPR, a veterinarian must have sufficient knowledge of your operation to make medical judgments, he says. It also means you agree to follow the veterinarian’s instructions.

In 2017, many antibiotics used in the feed or drinking water of livestock moved from over-the-counter status to requiring a Veterinary Feed Directive or prescription. However, a small percentage remained available OTC in other forms, such as injectables, intramammary tubes and boluses, Payne says.

GFI #263 specifically addresses this small percentage. The FDA expects the labels of these remaining OTC antibiotics to display the following language by June 11, 2023: “Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian.”

“This will end over-the-counter sales of antibiotics, and livestock owners will need a prescription from a veterinarian in the future if they want access to antibiotics,” Payne says.

He emphasizes that antibiotics won’t necessarily have to be purchased through a veterinarian, but a prescription will be required.

GFI #263 is available at www.fda.gov/media/130610/download.

More information from the FDA:

• GFI #263: Frequently Asked Questions for Farmers and Ranchers
• List of Approved New Animal Drug Applications Affected by GFI #263

Examples of affected products

Cephapirin, cephapirin benzathine

• Intramammary tubes: ToDAY and ToMORROW

Gentamicin

• Injectables: Garasol, Gentamicin Piglet Injection

Lincomycin

• Injectables: Lincomix 100, Lincomix 300, LincoMed 100, LincoMed 300

Oxytetracycline

• Injectables: Liquamycin LA-200, Noromycin 300 LA, Bio-Mycin 200, Agrimycin 200, etc.
• Boluses: Terramycin Scours Tablets, OXY 500 Calf Boluses

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

Sulfadimethoxine, sulfamethazine

• Injectables: Di-Methox 40%, SulfMed 40%
• Boluses: Albon, Sustain III Cattle & Calf Boluses, Supra Sulfa III Cattle & Calf Boluses

Tylosin

• Injectables: Tylan 50, Tylan 200