US pharmacopeia council of experts 2005–2010: Work plans new revision approaches and other enhancements

摘要

The United States Pharmacopeial Convention (the USP Convention), which meets at 5-year intervals, last convened in 2005. At that meeting, the convention membership elected a new Council of Experts for the 2005–2010 cycle. In turn, the Council elected members of Expert Committees charged with updating and revising the United States Pharmacopeia-National Formulary (USP-NF) and developing other authoritative standards and information. As one of their final activities, Expert Committees from the 2000–2005 cycle and USP staff carefully reviewed their work from the 2000–2005 cycle and reexamined the contents of USP-NF. From this comprehensive inventory emerged an updated and more focused new work plan directed toward acquiring missing monographs, updating monographs (typically because of advances in analytical technologies), and attending to General Chapter work (eg, dividing the General Chapter Chromatography <621> into smaller chapters) during the 2005–2010 cycle. Several elements of the work plan also speak to Resolutions adopted at the March 2005 Convention (available at www.usp.org/aboutUSP/resolutions. html) and prior ones as well. Because the work plan involves new approaches that affect both General Chapters (and thus the performance of tests and procedures) and monograph specifications—as well as the function of Pharmacopeial Forum and the introduction of new products—USP expects the plan to have a broad impact. This article briefly reviews some of these anticipated changes, informs constituents about how they can remain updated about progress and upcoming modifications to official texts, and invites participation in the standards-setting process.