§ 516.28 - Publication of MUMS-drug designations.  


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  • § 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 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.

    [72 FR 41017, July 26, 2007, as amended at 88 FR 45066, July 14, 2023]