Standards–Setting Process

The USP standards-setting process enables anyone to bring a standards-setting issue to the attention of USP. Once a standard is developed, it is proposed for 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 on the proposal through an electronic balloting system where they vote independently. 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 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.

Contact the USP scientific liaison responsible for the revision as indicated in Pharmacopeial Forum. Scientific Liaisons, their assignments, phone numbers, and e-mail addresses can be found in Scientific Support. In addition, contact information can be found in all electronic versions of the USP–NF. Finally, you can contact USP Documentary Standards Technical Support (301-816-8151 or stdsmonographs@usp.org).

Monograph proposals 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 dart of 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 e-mail to stacq@usp.org. For help in submitting revisions to existing or proposed monographs, send an e-mail to stdsmonographs@usp.org 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 (1-301-816-8151 or stdsmonographs@usp.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 either in USP–NF or in Pharmacopeial Forum (both of which are copyrighted) can be obtained for a fee by contacting USP Customer Service at custsvc@usp.org, by phone (301-881-0666 or 800-227-8772, by fax at 301-816-8148, or by mail to 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.

USP publishes proposed revisions to monographs and general chapter in the Pharmacopeial Forum, USP’s journal of public notice and comment (PF). Companies interested in keeping up with such changes should review PF, which available by subscription through the end of 2010, and then transitions to a freely available online publication in 2011. Also, check USP’s website for Accelerated Revisions to USP–NF Official text via Revision Bulletins, Interim Revision Announcements, and Errata.