2020–2025 Small Molecules 3 Expert Committee Work Plan

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Focus Areas

  • Gastrointestinal, renal, endocrine, ophthalmology, oncology, dermatology, and veterinary drug substance and drug product monographs

Expert Committee Charge

  • The Small Molecules 3 (SM3) Expert Committee is responsible for the development and revision of USP-NF monographs and their associated USP Reference Standards in the areas of gastrointestinal, renal, endocrine, ophthalmology, oncology, dermatology, and veterinary drug substance and drug product monographs.

Key Issues

  • Work with other Chemical Medicines Expert Committees, FDA, and stakeholders

Subgroups and Expert Panels

  • Subcommittee A – ophthalmology, oncology, dermatology
  • Subcommittee B – gastrointestinal, renal, and endocrine
  • Subcommittee C – veterinary
  • Chemical Medicines Collaborative Group
  • Joint Subcommittee (Reference Materials)

Standards Development

  • The latest 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

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