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 advocates for the use of excipient standards for pharmaceutical use. It also employs the stakeholder engagement model by collecting information, convening stakeholders, communicating formally and informally (PF, journal articles, Stimuli articles and e-newsletters) and sharing information through educational courses and allowing meeting Observers.

Key Issues

Working with Stakeholders to address the following Key Issues:

  • Developing new and revising existing USP-NF monographs and associated RS though the introduction of more specific analytical tests for Identification, assay, impurities and other tests that help to establish the quality of the pharmaceutical excipient
  • Collaborating with the Excipients Test Methods Expert Committee in identifying opportunities to introduce improved analytical tests that add to the existing list of compendial tests
  • Developing guidelines to define co-processed excipients/novel excipients, excipient nomenclature and impurities Advocating for the use and implementation of USP-NF excipient monographs and associated standards
  • Advocating for the use and implementation of USP-NF excipient monographs and associated standards for pharmaceutical use

Subgroups and Expert Panels

  • Excipient Science Strategy Joint Subcommittee
  • Polysorbates Joint Subcommittee
  • PLGA Joint Subcommittee
  • Excipient Composition and Impurities Joint Subcommittee
  • Cellulosics Subcommittee
  • Polymers Subcommittee
  • Fats, Oils, and Waxes Subcommittee
  • Starches Subcommittee
  • Stearates Subcommittee

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