Frequently Asked Questions: Standards–Setting Process
- How does a USP–NF standard become official?
- How can the status of the revision proposal that appeared in Pharmacopeial Forum be determined?
- How are new monographs proposed? How are revisions to official standards or standards already in Pharmacopeial Forum proposed?
- How are errors in the text of the USP–NF or text proposed in Pharmacopeial Forum reported? If a test procedure/specification seems incorrect, will USP review the monograph to determine its accuracy?
- Can copies of monographs or general chapters proposed in Pharmacopeial Forum or monographs or general chapters that have appeared in an edition of the USP–NF be obtained?
- How does USP propose revisions to a given monograph or general chapter?
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 Pharmacopeial Forum. Scientific Liaisons, their assignments, phone numbers, and email addresses can be found in the support section. In addition, contact information can be found in all electronic versions of the USP–NF. You can also contact USP Documentary Standards Technical Support (301-816-8151 or email@example.com).
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, send an email to firstname.lastname@example.org. For help in submitting revisions to existing or proposed monographs, send an email to email@example.com or call 301-816-8151.
Contact USP scientific liaisons in writing or by email with the nature of the error found in official text of the USP–NF or text proposed in Pharmacopeial Forum. USP contact information can be found here or in the front pages of the USP–NF. You also can contact USP Documentary Standards Technical Support (301-816-8151 or firstname.lastname@example.org). 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.
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 (email@example.com), 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 Pharmacopeial Forum (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 Pharmacopeial Forum, USP’s journal of public notice and comment (PF). The Pharmacopeial Forum (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.