Under this policy, the public may request the disclosure of information from USP. As a private organization, USP has implemented this policy to provide transparency to its standard-setting process while, at the same time, protecting the confidentiality of information in USP’s possession. The policy balances the request for information from the public against
- the rights of individuals to privacy;
- the need of USP to protect the confidentiality of trade secrets and other proprietary commercial or financial information;
- the need of USP to promote frank internal deliberations; and,
- the need of USP to pursue its standards-setting activities without disruption
Consistent with 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. Third party communications that may be disclosed in accordance with this policy 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; or
- 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 must be made to the USP Executive Secretariat (email@example.com), which is responsible for making decisions regarding the disclosure of information in accordance with this policy. 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.
This policy does not cover situations in which USP is compelled to disclose documents by subpoena or court order. In such cases, USP will comply with the applicable document request to the extent required by law.