2020–2025 Over-the-Counter (OTC) Methods & Approaches Expert Committee Work Plan

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Focus Areas

  • Strategy to establish over-the-counter (OTC) product specific standards
  • OTC drug product standards
  • OTC drug substance standards

Expert Committee Charge

  • The Over-the-Counter (OTC) Methods & Approaches Expert Committee is responsible for developing a framework to establish quality standards for OTC drugs, and providing expertise to support the development of product specific OTC monographs assigned to Small Molecules 1-5 Expert Committees.

Key Goals

  • Collaborate with FDA, Industry and stakeholders to discuss and address challenges to the development of OTC standards
  • Explore novel approaches to facilitate the development of OTC product specific standards
  • Establish strategies to develop novel approaches for impurities that are suitable for compliance and enforcement as well as adaptable to monitoring the quality of various OTC product formulations
  • Work with Small Molecules 1 – 5 Expert Committees to discuss and address issues that are related to the standard setting of USP monographs

Subgroups and Expert Panels

  • Diphenhydramine Subcommittee
  • Small molecules Collaborative Group

Learn more about the impact of this EC and its Associated Expert Bodies


•    Domenick Vicchio, Ph.D., Sr. Director, Small Molecules, dwv@usp.org
•    Edith Chang, Ph.D., Sr. Scientific Liaison – Team Leader, Small Molecules, yec@usp.org
•    James R. Austgen, Ph.D., Expert Committee Manager, jra@usp.org