2020–2025 Small Molecules 5 Expert Committee Work Plan

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Focus Areas

  • Pulmonary and steroids drug substance and drug product monographs
  • Selected general chapters that pertain to General Chapters <351> Assay for Steroids and <511> Single-Steroid Assay

Expert Committee Charge

  • The Small Molecules 5 (SM5) Expert Committee is responsible for the development and revision of USP–NF monographs and their associated USP Reference Standards in the areas of pulmonary, aerosol, and steroids drug substance and drug products.
  • The SM5 Expert Committee is also responsible for supporting the development of new general chapters related to pulmonary and steroids drug substances and drug products.

Key Issues

  • Work with other Small Molecules, General Chapters, and OTC Expert Committees, FDA and stakeholders to discuss and address issues related to standards setting
  • Continue the up-to-date program
  • Support important global health issues through collaboration with other organizations

Subgroups and Expert Panels

  • Small Molecules Collaborative Group
  • Joint Subcommittee (Reference Materials)

Standards Development

  • The latest ballot results can be found at 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

Contact

  • Domenick Vicchio, Ph.D., Director, Chemical Medicines - Chemical Medicines, dwv@usp.org
  • James R. Austgen, Ph.D., Expert Committee Manager, jra@usp.org