FDA issues new reporting requirements for sales of antibiotics given to food-producing animals

The U.S. Food and Drug Administration issued a finalized rule on Tuesday regarding federal reporting requirements for drug sponsors of all antimicrobials distributed to animals that either produce foodstuffs or are meant for human consumption.

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The new rule requires sponsors to report antimicrobial sales estimates that are species-specific. The resulting acquired data will complement larger information being gathered in collaboration with the CDC and the U.S. Department of Agriculture. The cooperative effort aims to reduce the prevalence of antibiotic resistant bacteria.

William T. Flynn, deputy director for science policy at the FDA’s Center for Veterinary Medicine, said, “This information will further enhance FDA’s ongoing activities related to slowing the development of antimicrobial resistance to help ensure that safe and effective antimicrobial new animal drugs will remain available for use in human and animal medicine.”

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