2020–2025 Small-Molecules 1 Expert Committee Work Plan

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Focus Areas

  • Antibiotic, antiviral, and antimicrobial drug substance and drug product monographs
  • Selected general chapters that pertain to the antibiotics and antimicrobial monographs

Expert Committee Charge

The Small Molecules 1 (SM1) Expert Committee is responsible for the development and revision of USP–NF monographs and their associated USP Reference Standards in the following therapeutic categories: antibiotics, antimicrobials and antivirals

Key Goals

  • Convertion of microbial assays to HPLC assays
  • Work with other Small Molecules and OTC Expert Committees, FDA and stakeholders to discuss and address issues that are related to the standard setting of USP monographs

Subgroups and Expert Panels

  • Subcommittee A (Antibiotics)
  • Subcommittee B (Antiviral and Antimicrobial)
  • Chemical Medicines 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