UMB Data Catalog

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  • UMB Dataset

    Substances nominated for inclusion on the 503B Bulks List: Ascorbyl Palmitate

    Alternate Title(s)
    Ascorbyl Palmitate: Summary Report
    Authors
    Melissa V. Yuen
    Stephanie L. Gianturco
    Laura L. Pavlech
    Kathena D. Storm
    2 more author(s)...
    Description

    The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the...

    Subject
    6-O-Palmitoylascorbic Acid
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Access Rights
    Unrestricted access