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FDA Issues Regulations on Tolerances for New Animal Drugs in Imported Food

FDA is setting new regulations on establishing, amending or revoking tolerances for residues of new animal drugs in imported animal-derived foods. The agency’s final rule sets procedures for requests to establish tolerances, “as well as procedures for reconsideration of action…

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or an administrative stay of action to establish, amend, or revoke an import tolerance,” FDA said. It also provides for FDA to self-initiate a review process to establish, amend or revoke an import tolerance. The tolerances are for “residues of new animal drugs not approved or conditionally approved for use in the United States, but lawfully used in another country and present in imported, animal-derived food and food products.” The new regulations take effect Jan. 19, 2022.