2020–2025 Small Molecules 4 Expert Committee Work Plan

Interested in learning more about the work of this Expert Committee?

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Focus Areas

  • Psychiatric, psychoactive, neuromuscular, radiopharmaceuticals, and imaging drug substance and drug product monographs
  • Selected general chapters that pertain to radiopharmaceuticals

Expert Committee Charge

  • The Small Molecules 4 (SM4) Expert Committee is responsible for the development and revision of USP-NF monographs and their associated USP Reference Standards in the areas of psychiatric, psychoactive, neuromuscular, radiopharmaceutical, and imaging drug substance and drug product monographs.
  • The SM4 Expert Committee is also responsible for supporting the development of general chapters related to radiopharmaceutical and imaging drug substances and drug products.

Key Goals

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

Subgroups and Expert Panels

  • Radiopharmaceutical Standards Expert Panel
  • 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


  • Domenick Vicchio, Ph.D., Sr. Director, Small Molecules, dwv@usp.org
  • Heather Joyce, Ph.D., Team Lead and Principle Scientist, hrj@usp.org
  • James R. Austgen, Ph.D., Expert Committee Manager, jra@usp.org