2015–2020 Excipient Monographs 1 Expert Committee Work Plan


  • Catherine Sheehan, DRSc, MS., MS., Senior Director - Excipients, cxs@usp.org

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Focus Areas

  • Monograph modernization with associated RS
  • New monograph development with associated RS
  • New excipient related chapters development
  • Excipient General Chapters update

Expert Committee Charge

  • The Excipient Monographs 1 Expert Committee is responsible for developing new and revising existing monographs and their associated reference standards for pharmaceutical excipients. The committee is also responsible for new excipient related General Chapters development and excipient General Chapters update. Excipient Monographs 1 and 2 Expert Committees collaborate through the Excipient Monograph Collaborative EC.

Key Issues

  • Priority Monograph Modernization Initiative.
    • Identify gaps in current excipient monograph specifications to assure fit for purpose in a global supply chain setting
  • Development of missing NF monographs and Associated RS
  • General Chapters development and update with methods to reassure the user that the quality of an excipient is fit for purpose

Subcommittees and Expert Panels

  • Subcommittee A (Small Molecules)
  • Subcommittee B (Polymers, Proteins, Clays)
  • Subcommittee C (Oils, Fats, Waxes, Plants)
  • <1195> Significant Change Guide For Bulk Pharmaceutical Excipients Joint Subcommittee
  • Biologics & Biotechnology (B&B) Joint Subcommittee
  • Co-processed Excipients Joint Subcommittee
  • Element Specific Chapters Joint Subcommittee
  • Metal Impurities Joint Subcommittee
  • Excipient Nomenclature Joint Subcommittee
  • Impurities Joint Subcommittee
  • Lactoses Joint Subcommittee
  • Polyethylene Glycol Joint Subcommittee
  • Polysorbates Joint Subcommittee
  • Excipients/Dietary Supplement/Foods/Herbal Medicines Joint Standards-Setting Subcommittee (JS3)
  • <1059> Excipient Performance Expert Panel

Ballot Results and Standards Development