Coordination of PF Submissions and New USP Reference Standards

April 3, 2006
USP recently announced a new process in which revisions and new monographs will not be published as official standards until the required USP reference standards are available for purchase [see Policies and Announcements, PF 32(3)]. We are pleased to announce another process change being implemented to better synchronize the availability of USP reference standards and the adoption of new documentary standards in the USP–NF. Effective March 28, 2006, any revision proposal involving the use of a first-time USP reference standard will be scheduled for publication in the PF only after a suitable reference standard bulk candidate has been received by USP. The timing of this new process affects regular revisions (not new monographs/general chapters) submitted to PF 32(4) and all revisions and new monographs/general chapters beginning with PF 32(5). While we acknowledge that this may cause a brief delay in publication of some proposed revisions and new monographs, we believe this process change is a benefit to USP customers and will ultimately lead to better public standards. It is anticipated that there may be some exceptions to this new process on a case-by-case basis.