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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
Contact
- Domenick Vicchio, Ph.D., Sr. Director, Small Molecules, dwv@usp.org
- Andrea Carney, Sr. Manager, Small Molecules, yec@usp.org
- James R. Austgen, Ph.D., Manager, Expert Committee Operations, jra@usp.org