USP Council of Experts & Expert Committees Overview

council of experts

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. The members of the 20 Expert Committees are in turn elected by the members of the Council of Experts. The various 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. As discussed below, Expert Panel members may serve even if conflicted, so long as any conflicts are disclosed adequately and on a timely basis.

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.

USP Expert Committees publish proposed standards for public comment, then review public comments related to the draft standards. The standards are adjusted based on Expert Committee consideration of the public comments, and then are adopted by those USP expert volunteers by a majority vote.

USP standards are in a process of continuous review and revision based upon new evidence, emerging public health concerns, and public requests for revision. The ongoing role of USP Expert Committees is to evaluate new data and to shape standards based upon the available evidence, public input, and the Expert Committee's expertise.

Code of Ethics

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 website. The purpose of the Code of Ethics and related obligations is to reflect and preserve USP's independence, integrity, reputation, and credibility as a volunteer-driven, unbiased, science-based standards-setting organization.

Expert Committee Members Serve as Individual Experts

When volunteers agree to serve on an Expert Committee, they are required to serve USP as individual experts, using their best personal, professional, and scientific judgment, and not serving any outside interest, including that of their employer. In keeping with this obligation, when Expert Committee members serve on or appear at an Expert Panel or other USP advisory body, they may do so only as a representative of USP (i.e., not on behalf of their employer, or any other outside interest). Similarly, Experts are barred from using USP Expert Committee membership in any way that is or appears to be motivated by private gain or outside interest.

Conflict of Interest and Confidentiality

Maintaining independence and impartiality is critical to the integrity and credibility of USP's standards-setting activities. All volunteers must remain free of actual or perceived conflicts of interest in the performance of their duties for USP. Expert Committee and Expert Panel members are required to submit and keep updated statements disclosing interests that may create conflicts, so that any conflicts that exist or emerge may be identified and resolved in a timely way. As a result, members are responsible for notifying USP staff and Expert Committee/Expert Panel Chairs about any actual or suspected conflicts, prior to any work on or discussion of any such matters in question. If conflicted, Expert Committee members may not participate in final discussions on a matter or vote. A different rule applies to Expert Panel members, who may participate if conflicted, so long as any conflicts have been adequately disclosed in a timely manner and to other members of the Expert Panel and to the Chair. Expert Panel recommendations also must be accompanied by a disclosure of any Expert Panel member conflicts of interest, so that the receiving Expert Committee may properly weigh and consider the input.

USP also has a confidentiality policy to protect confidential material in support of USP standards development. All Expert Committee and Expert Panel members are required to sign a confidentiality agreement regarding their respective obligations to maintain the confidentiality of 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.