Type of Posting: General Announcement
Posting Date: 23–Nov–2011
USP has revised the Pending Monographs Guideline to clarify that if there is an existing official USP or NF monograph, and the Authorized Pending Monograph is merged into the existing monograph to accommodate the Pending Monograph donor, the Revision Bulletin revising the existing monograph will become official immediately. This is consistent with USP’s Guideline on Use of Accelerated Processes for Revisions to the USP–NF, which allows an immediate official date where a monograph is revised via a Revision Bulletin to accommodate an article which otherwise would be out of compliance with the existing standards. It is also clarified that if FDA approval is received after the end of the 90-day comment period but before balloting as an Authorized Pending Monograph, the Draft Pending Monograph will be eligible to advance directly to official status.
This version updates and replaces USP Pending Monographs Guideline Version 2.6 as of 01 November 2011.