The USP standards-setting process enables anyone to bring a standards-setting issue to the attention of USP, ranging from establishing a new standard to revising an existing one. Once a standard or revision is developed for USP–NF, it is proposed for a 90-day public review and comment period in the Pharmacopeial Forum (PF). After the public review and comment period, the Expert Committee considers the comments received and determines whether further changes to the standard should be made. A proposal published in PF for comment is generally not reprinted in PF for additional comment prior to publication in the USP or the NF unless the Expert Committee or the Council of Experts Chairperson determines that reprinting is necessary due to the nature or significance of the comments received or changes made to the proposal. To finalize the standard, the Expert Committee members vote independently on the proposal through an electronic balloting system. A quorum of members (at least 51%) is required, and a majority of "yes" votes (51% of those voting) is required for a standard to be adopted. Expert Committee members are required to serve USP as individual experts (not representing their employer or any other interest), and are held to strict conflict-of-interest provisions, and must abstain from voting if they have a real or perceived conflict of interest as defined in USP's governing documents. The standards that USP deems official are set forth in its various compendia; for example, USP 35–NF 30 was published November 1, 2011, and is official from May 1, 2012 to April 30, 2013 (after which the official version will be USP 36–NF 31).
Proposal status is available on the USP web site. The listing includes information by publication regarding which proposals are expected to be included in the upcoming publication (Revisions), deferred to a future publication (Deferrals), and canceled (Cancellations).
Another way to obtain proposal status information is to contact the USP Scientific Liaison responsible for the revision as indicated in either the lists for the Revisions, Deferrals, and Cancellations or the PF. Scientific Liaison's contact information can also be found at the bottom of the monograph of interest. You also can contact Documentary Standards Technical Services: Submit Inquiry using WebForm or Email stdsmonographs@usp.org.
Monograph proposals for USP–NF should be submitted in writing to USP along with explanations for the proposals and data to support them. Guidelines describe the process. See "Submit Monographs and Revisions" for general information on this, and "Monograph Submission Guideline" for detailed information, including recommendations for what data to submit with specific proposals. In addition to these online resources, USP staff are available to assist interested sponsors. For assistance in submitting new USP–NF monographs or revisions to existing or proposed monographs, send an email to Katie McGowan, Standards Acquisition Manager (kmm@usp.org).
Contact USP in writing or by email with the nature of the error found in official text of the USP–NF or text proposed in PF. If you believe that a USP test/procedure is incorrect, please provide supporting data. If your observation is indeed correct, steps will be taken to rectify the monograph. USP contact information can be found at the bottom of the monograph of interest. You also can contact Documentary Standards Technical Services: Submit Inquiry using WebForm or Email stdsmonographs@usp.org.
For nonsubscribers, single copies of monographs and general chapters published in the USP–NF, which is copyrighted, can be obtained for a fee by contacting USP Customer Service by email (custsvc@usp.org), phone (301-881-0666 or 800-227-8772), fax (301-816-8148), or postal mail (12601 Twinbrook Pkwy, Rockville, MD 20852). Please note that to be in compliance with current USP requirements for a particular article, you must comply not only with the current monograph but also with all applicable general chapters and with the USP General Notices. The PF is available for free and is accessible from the USP web site. A one-time registration is required. The current PF plus an archive dating back to 2002 (PF 28 series) are freely available.
USP publishes proposed revisions to monographs and general chapters in the PF, USP’s journal of public notice and comment. The PF is available for free and is accessible from the USP web site. A one-time registration is required. The current PF plus an archive dating back to 2002 (PF 28 series) are freely available. Companies interested in keeping up with such changes should review PF and submit comments to USP, as necessary. Also, check USP’s website for Accelerated Revisions to USP–NF official text via Revision Bulletins, Interim Revision Announcements, and Errata.
As noted in the responses above, USP publishes proposed revisions to monographs and general chapters in the PF, USP’s journal of public notice and comment. After the public review and comment period, the Expert Committee considers the comments received and determines whether further changes to the standard should be made. Because the Expert Committee can – and frequently does – make revisions to the proposed text based on public comment, USP feels that it is important to clarify that documents in PF cannot be considered official text at the time of PF publication. We further state that they “may never become official” because of the potential for changes and revisions to the text prior to publication as official text in the USP-NF. It is USP’s hope and intent that revisions proposed in PF ultimately do become adopted into official text. However, we remind stakeholders that there is no assurance that they will become official text precisely as proposed in PF, i.e., without undergoing further revisions or changes.