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Monographs and General Chapters Affected by Revision to <1> Injections

Type of Posting: Notice of Intent to Revise

Posting Date: 31–Jul–2015

Targeted Official Date: 01–May–2016

Expert Committee: Various

In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that USP and its Expert Committees, as applicable, intend to revise multiple monographs and General Chapters in response to the revision of General Chapter <1> Injections.

General Chapter <1> was proposed for comment in Pharmacopeial Forum 38(6) and 39(5) and appeared in USP 38–NF 33 with a delayed official date of May 1, 2016. These revisions included changes to the title of General Chapter <1>, as well as moving sections into other General Chapters <7>, <659>, and <697>. USP has identified numerous monographs and General Chapters that reference General Chapter <1> and thus require revision to modify these references. These references will be updated when the monographs and General Chapters appear in USP 39–NF 34. A list of the monographs and General Chapters that will be modified can be found here.

All modifications will become official on May 1, 2016 to coincide with the official date of revised General Chapter <1>.

Please also see the Compendial Notice: New Revision Markup for Reference Changes in USP–NF for details on the revision markup used to identify the reference updates.

Interested stakeholders are encouraged to alert USP staff to any other effects they may recognize related to the revision of General Chapter <1>.

Should you have any questions or comments, please contact Desmond Hunt, M.S., Ph.D., Senior Scientific Liaison (301-816-8341 or dgh@usp.org).