USP Code of Ethics: Standards-Setting Processes

Our Principles

• USP will establish standards and information through processes that are science-based, credible, and unbiased
• USP will conduct its standards-setting activities in an open and transparent manner that allows for participation by all key constituencies

Our Policies

Official Statements and Interpretations

Because USP text and publications may have legal implications in the U.S. and elsewhere, their language must stand on its own. USP shall not provide an official ex post facto interpretation to one party, thereby placing other parties without that interpretation at a possible disadvantage.

In addition, USP shall not provide an official opinion as to whether a particular article does or does not comply with compendial requirements, except as part of an established USP verification or other conformity assessment program that is conducted separately from, and independent of, USP's standard-setting activities.

Public Participation in Open Meetings

All meetings of USP Expert Committees shall be open to the public, except that a meeting or a portion of a meeting may be held in closed session if the Chairperson of the Expert Committee or the Chairperson of the Council of Experts determines in their discretion that there is good and sufficient reason for closure. Such reasons may include among others: review or discussion of trade secrets or confidential, commercial information; or review or discussion of matters, the premature disclosure of which, could be detrimental to USP's standard-setting activities. If a determination is made to close a meeting, the reason for such closure shall be noted in the minutes of the meeting. Attendance at a meeting of an Expert Committee meeting shall be subject to the provisions set forth in the Rules and Procedures of the Council of Experts and the procedures posted on USP's website. A public calendar shall be maintained and posted on the USP website showing, to the extent feasible, future Expert Committee meetings.

Audio and video recordings may be made at any open meeting or conference if approved in advance by USP so as to avoid disruption of the proceedings. The Chairperson of the Expert Committee or the Chairperson of the Council of Experts may decline permission for audio or video coverage that would adversely affect the meeting.

In an effort to neither impede scientific debate nor interfere with the deliberative process implicit in USP's mission, USP does not permit direct attribution of individuals, by name or by organization, who participate in proceedings at USP Expert Committee meetings, unless the individual grants permission to be quoted.

Document Disclosure

USP will provide disclosure of information and records regarding its standard-setting activities consistent with the rights of individuals to privacy, the need to protect the confidentiality of trade secrets and other proprietary commercial or financial information, and the need of USP to promote frank internal deliberations and to pursue its standards-setting activities without disruption. Pursuant to this policy, general information pertaining to USP's standard-setting and other activities, including information regarding the work and deliberations of USP's Council of Experts and Expert Committees, is posted and maintained on the USP website.

In addition, communications between USP and third parties relating to standard-setting activities will be made available upon specific written request, including copies of written correspondence to and from third parties and memoranda of telephone conversations and meetings with third parties. Such third party communications do not include communications of any kind among or between USP staff and members of its Board of Trustees, Council of Experts or Expert Committees. Nor will USP disclose documents containing any trade secrets or confidential commercial secrets of third parties, if such documents have been specifically designated as such when submitted to USP; provided, however, that documents submitted to USP by a third party containing trade secrets or confidential commercial secrets that ordinarily would be contained in a New Drug Application or Supplement thereto may be disclosed to the Food and Drug Administration upon its request in its review of any revision or proposed revision of the United States Pharmacopeia, National Formulary or other USP compendium.

All requests for documents shall be made to the USP Executive Secretariat, which shall be responsible for making decisions as to the disclosure of information. A request may be refused solely on the basis that it is unduly burdensome or if it is determined by USP that diversion of personnel from higher priority duties would be unreasonable.

USP reserves the right to charge reasonable fees for disclosure of any documents requested under this policy including: copying charges; charges for time spent by USP personnel to locate, review, and copy such documents; postage fees; and other expenses associated with responding to the request.