Standards-Setting Activities of USP's Council of Experts

This report provides plans for the USP Council's work in the 2010-2015. This articles contains online bonus material.
Mar 02, 2011
Volume 35, Issue 3

The US Pharmacopeial Convention (USP) was founded by volunteer physicians who met in 1820 with the goal of producing the United States Pharmacopeia (1, 2). Convention members continued to meet at 10-year and later at 5-year intervals to monitor revision of the original publication by the Committee of Revision, now known as the Council of Experts. USP acquired the National Formulary (NF) in 1975, with conversion of the latter into a book of excipient standards. Both compendia are official compendia of the United States and are continuously revised with a yearly publication, followed by two supplements. The first USP (USP 0) is now entering its 34th presentation and is combined with NF, now in its 29th presentation, with an official date of May 2011. USP-NF standards are public standards for medicines legally marketed in the US and are enforceable by FDA. They can be referenced by manufacturers and regulatory and compendial authorities throughout the world either in law or in private regulatory filings. Associated USP reference materials are distributed in more than 130 nations.

In recent years, USP's compendial offerings have expanded to include USP's Dietary Supplements Compendium, Food Chemicals Codex (FCC), and the USP Pharmacists' Pharmacopeia for compounding pharmacists. USP is also working to consolidate monographs for medicines legally marketed outside the United States through a Web-based publication termed the USP Medicines Compendium, which builds on and expands USP's work for non-US monographs intended for neglected infectious diseases.

USP s compendia and reference materials are made available through decisions of elected volunteer experts who form the Council of Experts and work closely with USP staff in the revision process. USP plans to publish the work plans of the Council online and to update them frequently during the current 2010-2015 revision cycle ( This article presents an overview of the work of the Council in the 2010-2015 revision cycle as its moves through its first year. The publication will be linked to a finalizing report of the work of the Council at the April 2015 USP Convention.

The 2010-2015 revision cycle

USP delegates met in April 2010 and elected the 20 volunteer members of the Council of Experts' Expert Committees. Each member of the Council of Experts serves as chair of an Expert Committee. Expert Committee members are elected by the Council members in accordance with USP Rules and Bylaws (3). As needed, a new Expert Committee maybe formed during a cycle by the USP Board of Trustees, and this occurred in the current revision cycle when the Board created the 21st Expert Committee of the cycle to execute monographs for the USP Medicines Compendium.

Figure 1: Structure of the USP 2010–2015 Expert Committees
The Executive Committee of the Council of Experts includes all Expert Committee chairs and promotes information exchange, specific initiatives, and other activities that support Council of Experts' operations. USP's CEO functions as Chair of the Council of Experts, although new rules in USP's Bylaws allow delegation of this responsibility (4). Figure 1 provides an overview of the structure of the Council of Experts relative to USP's compendia.

As USP moves through the first year of the 2010-2015 revision cycle, Expert Committees are working with staff liaisons and stakeholders to finalize and disseminate their work plans. These work plans build on and extend the legacy work plans of the Expert Committees from the 2005-2010 revision cycle. The overall work plan is designed to enhance and strengthen standards in all of USP's compendia, including USP-NF, FCC, the Dietary Supplement Compendium, and the USP Pharmacist's Pharmacopeia. All compendia require extensive and continuing work to ensure a full cohort of up-to-date monographs with allied reference materials (i.e., official USP reference standards).

Table I: USP 2010–2015 Expert Panels and Charges.
During the 2010-2015 revision cycle, USP plans to post online all of its work plans, along with additional information, such as the number of general chapters and monographs assigned to each Expert Committee, monographs and general chapters that need revision, and planned new general chapters and monographs. The following sections provide a review, organized by compendia following discussion of the work of the Nomenclature, Safety, and Labeling Expert Committee, of the 21 Expert Committees that are charged with revising USP's compendia and ensuring the availability of USP's reference materials. USP's Expert Committees may form ad hoc Expert Panels during the current revision cycle, continuing with modifications the work of Advisory Panels in the prior revision cycle (5). These Expert Panels convene to address a specific topic and disband when their tasks are completed. As of the end of calendar year 2010, 15 Expert Panels had been formed (see Table I).

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