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Plan now for antibiotic changes on the horizon

published: November 26th 2021
by: Linda Geist
source: University of Missouri

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 Me-dicine published Guid-ance for Industry No. 263(opens in new window) (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 (VCPR), 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 Direc-tive or prescription. How-ever, 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 in new window).
More information
from the FDA:
    •GFI #263: Frequently Asked Questions for Farm-ers and Ranchers(opens in new window)
    •List of Approved New Animal Drug Applications Affected by GFI #263 (opens in new window)
Examples of affected products
Cephapirin, cephapirin benzathine
    •Intramammary tubes: ToDAY and ToMOR-ROW
    •Injectables: Garasol, Gentamicin Piglet Injec-tion
    •Injectables: Lincomix 100, Lincomix 300, Lin-coMed 100, LincoMed 300
    •Injectables: Liquamy-cin 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, Alba-dry Plus
Sulfadimethoxine, sulfamethazine
    •Injectables: Di-Me-thox 40%, SulfMed 40%
    •Boluses: Albon, Sustain III Cattle & Calf Boluses, Supra Sulfa III Cattle & Calf Boluses
    •Injectables: Tylan 50, Tylan 200

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