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FDA issues rule requiring veterinary supervision of medically important antimicrobials

WASHINGTON, Jun. 2, 2015 —The US Food and Drug Administration announced today its final rule for the Veterinary Feed Directive (VFD) — a move that is said to be “an important piece of the agency’s overall strategy to promote the judicious use of antimicrobials in food-producing animals.”“Over the past several years, the FDA has taken important steps toward fundamental change in how medically important antibiotics can be legally used in feed or water for food-producing animals,” the agency said in a fact sheet on the new rule.

FDA is now “moving to eliminate the use of such drugs for production purposes (i.e., growth promotion and feed efficiency) and bring their remaining therapeutic uses in feed and water under the supervision of licensed veterinarians – changes that are critical to ensure these drugs are used judiciously and only when appropriate for specific animal health purposes,” the agency added.

The VFD final rule outlines the process for authorizing use of VFD drugs (animal drugs intended for use in or on animal feed that require the supervision of a licensed veterinarian) and provides veterinarians in all states with a framework for authorizing the use of medically important antimicrobials in feed when needed for specific animal health purposes.

Antimicrobials that are not deemed medically important to humans by FDA — anticoccidials and bacitracin, for example — do not require a VFD but should be used judiciously and only for approved indications.

The VFD final rule continues to require veterinarians to issue all VFDs within the context of a veterinarian-client-patient relationship (VCPR) and specifies the key elements that define a VCPR.

The final rule will require veterinarians to follow state-defined VCPR requirements; in states where the FDA determines that no applicable or appropriate state VCPR requirements exist, veterinarians will need to issue VFDs in compliance with federally defined VCPR requirements. All veterinarians need to adhere to a VCPR that includes the key elements in the final rule, FDA said.

“The actions the FDA has taken to date represent important steps toward a fundamental change in how antimicrobials can be legally used in food-producing animals,” said Michael R. Taylor, FDA deputy commissioner for foods.

“The VFD final rule takes another important step by facilitating veterinary oversight in a way that allows for the flexibility needed to accommodate the diversity of circumstances that veterinarians encounter, while ensuring such oversight is conducted in accordance with nationally consistent principles.”

In December 2013, the agency published a guidance document, which calls on animal drug manufacturers of approved medically important antimicrobials that are put into water or feed of food-producing animals to voluntarily stop labeling them as drugs that can be used to promote animal growth and change the labeling of their products for the remaining uses to require veterinary oversight of these drugs when they are used for therapeutic purposes. All of the affected makers of these drugs have committed in writing to participate in the strategy.




Posted on June 2, 2015

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