2015–2020 Chemical Medicines Monographs 5 Expert Committee Work Plan

Contact

Domenick Vicchio, Ph.D., Director, Chemical Medicines - Chemical Medicines , dwv@usp.org

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

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Upcoming Official Meetings

  • To be determined

Past Meetings – Executive Summaries

Focus Areas

  • Pulmonary and steroids drug substance and drug product monographs
  • Selected general chapters that pertain to General Chapters <351> Assay for Steroids and <511> Single-Steroid Assay

Expert Committee Charge

  • The Monographs–Chemical Medicines 5 (CHM5) Expert Committee is responsible for the development and revision of USP–NF monographs and their associated USP Reference Standards in the areas of pulmonary and steroids drug substance and drug products.
  • The Monographs–Chemical Medicines 5 (CHM5) Expert Committee is also responsible for supporting the development of new general chapters related to pulmonary and steroids drug and drug products.

Key Issues

  • Work with other Chemical Medicines Expert Committees, FDA and stakeholders to discuss and address issues that are related to the standard setting of USP monographs
  • Continue the up-to-date program of USP on monographs and general chapters
  • Support important global health issues through collaboration with other organizations

Subgroups and Expert Panels

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

Ballot Results and Standards-Development