USP Council of Experts–Overview

General Information

The USP Council of Experts members are elected by the USP Convention membership at its every–five–year meeting and serve as chairs of USP Expert Committees. Expert Committees address specific standards–setting areas within USP, such as Small Molecules, Biologics and Biotechnology, General Chapters, and others.

Expert Panels are formed to provide additional expertise on a particular compendial topic, thereby supplementing Expert Committee expertise. Expert Panels are intended to introduce flexibility and scalability into USP’s standards–setting activities, and help ensure that USP standards are based on the best scientific knowledge available.

Expert Panels are advisory to one or more Expert Committees; they are not decision–making bodies. Expert Panels, when formed, will have a specific charge (including scope of work, deliverables, and timeline for completion), and will be dissolved at the conclusion of their work.

Roles and Responsibilities

USP Expert Committees are responsible for developing and revising standards for medicines and foods that appear in the United States Pharmacopeia and the National Formulary (USP–NF), the legally recognized standards compendia for drugs, drug products, and dietary supplements; in the Food Chemicals Codex; and in other related publications.

Council of Experts and Expert Committee members develop and review monographs, General Chapters and test methods, and collaborate on scientific topics supporting the standards that appear in USP's compendia.

Conflict of Interest and Confidentiality Information

Maintaining independence and impartiality is critical to the integrity and credibility of USP’s standard–setting activities. All volunteers must remain free of actual or perceived conflicts of interest in the performance of their duties for USP. Expert Committee members are required to submit and keep updated statements disclosing interests that may create conflicts.

USP also has a confidentiality policy to protect confidential material in support of USP standards development. Expert Committee members must enter into a mandatory signed agreement to maintain the confidentiality of all information gained in the course of their USP activities. Information obtained at USP may not be used or disclosed for any purpose, unless already publicly available.

All members of the Council of Experts, Expert Committees, and Expert Panels are subject to USP Policies, Rules, and Code of Ethics, which are available on the USP Web site.

Election Process

At the April 2010 USP Convention, the USP Nominating Committee for the Council of Experts will nominate two qualified candidates to stand for election as chair of each Expert Committee. The candidates elected by the USP Convention Membership will serve as chairs of the Expert Committees and members of the Council of Experts.

A smaller Nominating Committee that comprises the president of the USP Convention, the vice chair of the Nominating Committee, the chair of the Council of Experts, and the chair of the Expert Committee will nominate qualified candidates to stand for election as Expert Committee members. Expert Committee members are elected by the Council of Experts after the close of the USP Convention meeting.