Title 21

SECTION 516.28

516.28 Publication of MUMS-drug designations.

§ 516.28 Publication of MUMS-drug designations.

FDA will periodically update a publicly available list of MUMS-designated drugs. This list will be placed on file at the FDA Division of Dockets Management, 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.

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