Governance of Standard Setting Committees
- Council of Experts: The Council of Experts is the body that oversees USP's scientific and standards-setting decisions. Members of the Council are elected by the USP Convention membership at its every-five-year meeting. Each Council member serves as the chair of an Expert Committee for a five-year term. The chairs in turn elect the members of the Expert Committees.
- Expert Committees: USP Expert Committees are responsible for developing and revising USP standards that comprise its compendia: the USP and the NF, USP Compounding Compendium, Herbal Medicines Compendium, Dietary Supplements Compendium, and Food Chemicals Codex. They also approve USP Reference Standards specified for use with the compendia. The Expert Committees are each focused on a different area of standards for medicines (including chemical medicines, biologic medicines, excipients, and compounded preparations), dietary supplements, and food ingredients. 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 volunteers by a majority vote.
- Subcommittees: Expert Committees often form small subsets of Expert Committee members to address a specific issue.
- Joint Standard Setting Subcommittees: These bodies are made up of Expert Committee members from at least two Expert Committees. They work on standards that are cross cutting. Joint Standard Setting Subcommittees can approve standards.
- Expert Panels: Expert Panels are formed to provide additional expertise on a particular compendial topic, thereby supplementing Expert Committee expertise. Each Expert Panel has a specific charge (including scope of work, deliverables, and timeline for completion) and will be dissolved at the conclusion of its work. Expert Panels are advisory to one or more Expert Committees; they are not decision-making bodies.
Rules & Procedures of the 2020–2025 Council of Experts
In accordance with USP Bylaws , these provisions define the standards-setting activities that are the responsibility of the USP Council of Experts. View the 2020-2025 Rules & Procedures for the Council of Experts.
For additional guidelines on documentation standards and revisions, click here.
- 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.
The USP Standards of Conduct Brochure provide information how members of the USP Council of Experts, Expert Committees, and Expert Panels can identify, disclose, and resolve Conflicts of Interest and Confidentiality. 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.