Revision to USP Pending Monographs Guideline

Posting Date: 09 November 2009

USP has revised the Pending Monographs Guideline to indicate the implementation period for a Pending Monograph advancing to official United States Pharmacopeia status via Revision Bulletin. The Guideline now states that "the monograph is official and legally enforceable as a USP monograph as of the date specified in the Revision Bulletin which will be no less than six months after the posting of the Revision Bulletin". This six-month implementation period is consistent with that of the USP-NF annual edition and its Supplements.

This version updates and replaces USP Pending Monographs Guideline Version 2.3 as of October 1, 2009.

Should you have questions, please contact Karen A. Russo, Ph.D., Vice President, Small Molecules ( 301-816-8379).

Download the USP Pending Monographs Guideline V2.4  (35KB)