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FDA Imposes New Restrictions on Antibiotics

If you sell livestock feed or medicated feeds, then you likely have heard about the FDA’s Veterinary Feed Directive (VFD) that was introduced in 2015. Over the past several years, the FDA has taken steps to regulate how medically important antibiotics can be legally used in feed or water for food-producing animals. They have moved to eliminate the use of these drugs for production purposes and bring their remaining therapeutic uses in feed and water under the supervision of licensed veterinarians.

After the latest revision of this directive, any remaining medically important antimicrobials from OTC marketing channels are being removed, closing the loophole that was created in the initial VFD wording. Several drugs will be affected by this rule, and livestock owners will now have to access these through a veterinarian with which the producer has a valid veterinary-client-patient relationship (VCPR). In short, this means that products that you may have purchased from the local feed store, farm supply, etc. will likely no longer be allowed on those shelves (without proper licensing). Those who do not regularly consult a veterinarian will need to establish a valid VCPR in order to purchase these products.


The following products will be moving to RX Labeling soon:


• Injectables such as Liquamycin LA-200, Noromycin 300 LA, Bio-Mycin 200, Agrimycin 200, etc.

• Boluses such as Terramycin Scours Tablets and OXY 500 Calf boluses.

Penicillins (Penicillin G procaine, penicillin G benzathine)

• Injectables such as Penicillin Injectable, Dura-Pen, Pro-Pen-G, Combi-Pen 48, etc.

• Intramammary tubes such as Masti-Clear, Go-dry, and Albadry Plus.

Sulfa-based antibiotics (Sulfadimethoxine, sulfamethazine)

• Injectables such as Di-Methox 40% and SulfMed 40%.

• Boluses such as Albon, Sustain III Cattle & Calf Boluses and Supra Sulfa III Cattle & Calf Boluses.


• Injectables such as Tylan 50 and Tylan 200.

Cephapirin, cephapirin benzathine

• Intramammary tubes such as ToDAY and ToMORROW

The latest update from the FDA on the VFD (Guidance #263) includes a two-year phase-in for the manufacturers of these products to make label changes and come into compliance with the guidance. This means that all products covered under Guidance #263 are to be removed from OTC availability by June 11, 2023. You should expect to see these medications disappearing from store shelves over the next year as manufacturers finalize their label changes and refine their marketing materials to reflect the new rule.

Remember, these products will not leave the market entirely. They will continue to be available, with added regulation that requires a VCPR and a prescription to purchase from a veterinarian or licensed pharmacy. It is of the utmost importance to us at WPVS to make this information known to our customers so that they may stay informed on the major changes that are on the horizon.


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