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21CFR516.28

§ 516.28 Publication of MUMS-drug designations.

Regulation Text

FDA will periodically update a publicly available list of MUMS-designated drugs. This list will be placed on file at the FDA Dockets Management Staff, and will contain the following information for each MUMS-designated drug: (a) The name and address of the sponsor; (b) The established name and trade name, if any, of the drug; (c) The dosage form of the drug; (d) The species and the proposed intended use for which MUMS-drug designation was granted; and (e) The date designation was granted.

Authority

21 U.S.C. 360ccc-1,360ccc-2,371.

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