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T-28: Safety Evaluation of Bulk Drug Substances for Use in Compounding

Poster Presenter

      Jennifer Shing

      • FDA
        United States


The goal was to assess the safety and pharmacology of bulk drug substances that may be used for compounding developed by the U.S. Food and Drug Administration (FDA) through regulation (section 503A of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 353a).


Publicly accessible sources such as PubMed, clinical guidelines, and recommendations by subspecialty groups or government agencies were evaluated. The FDA Adverse Event Reporting System (FAERS) and Center for Food Safety and Nutrition Adverse Event Reporting System (CAERS) databases were searched.


To develop the 503A bulks list, FDA requested and received nominations from the public (81 FR 91071). These bulk drug substances were nominated for a variety of proposed uses. FDA presents its review of nominations at regular meetings of the Pharmacy Compounding Advisory Committee (PCAC) to obtain the PCAC’s advice on whether to include the substance on the 503A bulks list. Examples of substances previously presented at PCAC meetings include glutaraldehyde, rubidium chloride, tea tree oil, and N-acetyl-D-glucosamine. We will discuss safety assessments of select bulk drug substances, and the importance of pharmacology and toxicology findings, for the development of the 503A bulks list.


FDA is involved in reviewing publicly available sources and the biomedical literature for pharmacology, toxicology, pharmacokinetics, and clinical studies for safety and efficacy, regarding bulk drug substances nominated for the 503A bulks list. This abstract reflects the views of the authors and should not be construed to represent FDA's views or policies.

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