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e-CFR data is current as of February 24, 2021

Title 21Chapter ISubchapter EPart 556Subpart A → §556.1


Title 21: Food and Drugs
PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
Subpart A—General Provisions


§556.1   Scope.

(a) The Federal Food, Drug, and Cosmetic Act requires an applicant seeking approval or conditional approval of a new animal drug to submit a proposed tolerance as part of its new animal drug application when such a tolerance is needed to assure that the proposed use of the new animal drug will be safe (see sections 512(b)(1)(H) and 571(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act). FDA assigns tolerances for animal drugs used in food-producing animals as part of the application approval process. Tolerances for approved and conditionally approved new animal drugs are codified in subpart B of this part.

(b) Compounds that have been found to be carcinogenic are regulated under subpart E of part 500 of this chapter.

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