Governance

The United States Pharmacopeial Convention (USP) is a nonprofit scientific organization founded in 1820 in Washington, D.C., that develops and disseminates public compendial quality standards for medicines and other articles (Bylaws, Articles II, VII). USP’s mission is “to improve the health of people around the world through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.” Standards for an article recognized in a USP compendium are typically expressed in the article's monograph, the General Notices, and applicable general chapters (such as General Chapter <1> Injections). Depending on the particular compendium, USP monographs and general chapters may include standards for the identity, as well as the strength, quality and purity of medicines, food ingredients, or dietary supplements, for both products and constituent ingredients. They also may include standards for packaging and labeling. USP Reference Standards are often specified as a component of particular standards, serving as required comparison standards in particular tests and assays. USP’s primary compendia of standards are the United States Pharmacopeia and the National Formulary (USP–NF). USP standards may be adapted or adopted by any organization or government worldwide; most standards in USP–NF have, for example, been adopted in the U.S. under federal law. USP has no role in enforcement; that is left to FDA and other government authorities in the U.S. and elsewhere.

The USP Council of Experts and its Expert Committees are the scientific decision-making body of USP. Members of the Council of Experts 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 Committee members are elected by the Council of Experts.

Expert Panels are formed to provide additional expertise on a particular compendial topic, thereby supplementing Expert Committee expertise. Expert Panels provide flexibility and scalability to 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.

The USP Council of Experts and its Expert Committees are responsible for developing and revising standards for medicines and foods that appear in USP’s compendia, including the United States Pharmacopeia and the National Formulary (USP–NF), which contains quality standards for drug ingredients, drug products, and dietary supplements; the Food Chemicals Codex (FCC); the Medicines Compendium; the Dietary Supplements Compendium; and in other related publications. Members of the Council of Experts and its Expert Committees develop and review monographs, General Chapters, and testing methods, and collaborate on scientific topics supporting the standards that appear in USP's compendia.

The average Expert Committee member spends approximately 3.5 hours per week on USP activities. Expert Committees generally meet face-to-face once or twice per year, with teleconferences/Web meetings as required.

While each Expert Committee requires specific expertise in either analytical chemistry, analytical biochemistry, measurement science, food and dietary supplement science, or other applied sciences, most Expert Committee members have advanced degrees (doctoral degrees or the equivalent based on extensive experience), and are actively working in related scientific and/or regulatory disciplines.

The USP Nominating Committee for the Council of Experts nominates two qualified candidates to stand for election as chair of each Expert Committee at the every-five-year USP Convention. Nominees elected by the USP Convention Membership serve as chairs of the Expert Committees and members of the Council of Experts.

Each member of the Council of Experts nominates qualified candidates for his or her own Expert Committee to stand for election. Expert Committee members are then elected by the full Council of Experts, including the Chair of the Council of Experts.

The term of service is five years, until the next Council of Experts is elected by the USP Convention.

Expert Panel terms vary, from a few months to the full five-year term or longer.

Maintaining independence and impartiality is critical to the integrity and credibility of USP's standard-setting activities. Members of the Council of Experts and its Expert Committees must remain free of actual or perceived conflicts of interest in the performance of their duties for USP. Members of the Council of Experts and its Expert Committees are required to submit and keep updated statements disclosing interests that are actual or potential conflicts. Members of Expert Panels also are required to disclose any interests or conflicts that may arise in the course of their standards-setting activities. Interests disclosed on Disclosure Statements will also be disclosed to the other members of an Expert Committee or Expert Panel (and any recommendations from an Expert Panel will be accompanied by a disclosure of Expert Panel member interests and conflicts).

USP also requires Council of Expert members to maintain the confidentiality of confidential information and data submitted to USP in support of USP standards development. Expert Committee members are each required to sign a Confidentiality Agreement to maintain the confidentiality of all information gained in the course of their USP standards-setting activities. Information obtained from USP may not be disclosed to anyone by a Council of Experts or Expert Committee member or used for any non-USP related purpose , unless USP has already determined it is publicly available.

The membership of each USP Expert Committee varies according to its responsibilities. USP strives for a balance of industry (including innovator, generic, and over-the-counter company representatives), academia, healthcare practitioner, regulatory, and independent experts on its Expert Committees. USP seeks the most qualified volunteer experts regardless of organizational affiliation. USP also strives to include representatives from countries other than the U.S. to reflect the global use of USP's standards.

USP creates and continuously revises its compendial standards through a unique public-private collaborative process, which involves interested industry stakeholders, the government, and other interested parties from anywhere in the world. The standards can originate from pharmaceutical manufacturers or other sponsors from the draft monographs and data they provide. USP's scientific staff and volunteer experts review this input, conduct necessary laboratory tests, and ensure that the information is subject to public review and comment. The public process helps to refine and finalize this information for publication in USP compendia. USP Expert Committees make the final decisions to approve and publish the standards.

Expert Panels are formed solely to advise an Expert Committee on scientific and technical matters for which the Expert Committee seeks additional expertise. Expert Panels usually meet and address the issues, then form recommendations to the Expert Committee. The Expert Committee has final decisional authority on any recommendation of an Expert Panel.

Under the leadership of the Chair of the Council of Experts, each Expert Committee and Expert Panel is supported by a team of USP staff including chiefs, vice presidents, directors, scientific liaisons, reference standards scientists, project managers, and administrative staff.