2015–2020 Chemical Medicines Monographs 6 Expert Committee Work Plan

Contact

Leonel Santos, Ph.D., Director, Chemical Medicines - Chemical Medicines, lxs@usp.org

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

Download Roster Observe a Meeting

Upcoming Official Meetings

  • September 20–21, 2017 face-to-face meeting

Past Meetings – Executive Summaries

Focus Areas

  • Over-the-counter (OTC) drug products
  • Generally Recognized as Safe and Effective (GRASE) Drug Substances
  • Selected general chapters that pertain to General Chapter <1086> Impurities in Drug Substances and Drug Products and the proposed General Chapter <476> Organic Impurities in Drug Substances and Drug Products

Expert Committee Charge

  • The Monographs–Chemical Medicines 6 (CHM6) Expert Committee is responsible for the development and revision of USP-NF monographs and their associated USP Reference Standards in the areas of over-the-counter drug substance and drug products

Key Issues

  • Bring up-to-date each of the official USP drug substance and drug product monographs
  • Meeting the challenge to establish/revise the public standards for Over-the-Counter Medicines

Subgroups and Expert Panels

  • Inorganic Subcommittee
  • Chemical Medicines Collaborative Group
  • Joint Subcommittee (Reference Materials)

Ballot Results and Standards-Development