2020–2025 Complex Excipients Expert Committee Work Plan

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Focus Areas

  • Cellulosics
  • Fats and Oils
  • Polymers
  • Starches
  • Stearates
  • Waxes

Expert Committee Charge

  • The Complex Excipients Expert Committee is charged with developing new and revising existing monographs and their associated reference standards for pharmaceutical excipients. The Expert Committee also advocates for the use of excipient standards and continuously engages its stakeholders through regular interactions, such as excipients stakeholder forums, workshops, and roundtables. The Expert Committee communicates its excipient science strategy through Stimuli articles and peer-reviewed journals, encouraging stakeholder participation in the standard setting process.

Key Issues

  • Revise and maintain existing USP-NF monographs and associated RS that supports the update of existing monographs by introducing more specific analytical tests for Identification, assay, impurities and other tests that help to ensure the quality of the pharmaceutical excipient. 
  • Develop missing high priority excipients already in US regulated drug products on the market including novel excipients such as co-processed excipients 
  • Develop guidelines to define co-processed excipients/novel excipients, excipient nomenclature and impurities Advocate for the use and implementation of USP-NF excipient monographs and associated standards

Subgroups and Expert Panels

  • TBD

Standards Development

  • The latest documentary standard ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here

Learn more about the impact of this EC and its Associated Expert Bodies

Articles

Contact

  • Catherine Sheehan, DRSc, MS., MS., Senior Director - Excipients, cxs@usp.org
  • Richard Lew, MS., Expert Committee Manager- Excipients, rll@usp.org