Central to USP’s achievements are the contributions of countless experts, who volunteer their time and knowledge in USP’s Council of Experts and Expert Committees and Panels. USP standards are in a continuous process of review and revision based upon new evidence, emerging public health concerns, and public requests for revision. Input from our volunteers is crucial for maintaining these high standards and preserving public trust.
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.
- Subcommittees: Expert Committees often form small subsets of Expert Committee members to address a specific issue.
- 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.
Guidelines
- 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.
Expert Volunteers are required to submit and keep updated statements disclosing relevant interests, so that any conflicts that exist or emerge may be identified and managed in a timely way. Expert Volunteers are responsible for notifying USP staff and Expert Body Chairs about any actual or potential conflicts prior to any work on or discussion of any such matters in question. If conflicted, Expert Committee members may not vote on a matter. Expert Panel members and Expert Advisors do not vote, but any recommendations they make will be accompanied by a disclosure of any their conflicts of interest, so that the receiving Expert Committee may properly weigh and consider the input.
The USP Standards of Conduct Brochure provides information on how Expert Volunteers must identify, disclose, and manage Conflicts of Interest. The Brochure also explains USP’s confidentiality policy, which protects confidential material in support of USP standards development. All Expert Volunteers must sign a confidentiality agreement requiring them 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.