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FDA Publishes Final Rule on Tolerances for Animal Drugs in Food

On July 10 FDA finalized its rule on Updating Tolerances for Residues of New Animal Drugs in Food.  This rule was originally proposed in 2012 with a revision proposed in 2016.  The rule will become effective September 9.

As described in the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) Update, the new rule does not set new tolerances, but it does standardize and clarify “the standards for determining, codifying, and updating tolerances, and [it] also provides a definition section of key terms that the FDA uses in the determination of tolerances.  This final rule will enhance understanding of tolerance determination and improve the overall readability of the relevant regulations.”

This rule follows in the footsteps of the Guidance on Evaluating Animal Drug Safety in Food-Producing Animals and the Strategy for Antibiotic Stewardship in Food Animal Production in FDA’s continued interest in ensuring that drugs are used to treat animals for food in a way that is protective of human health.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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