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Monographs Affected by Revision to <1211> Sterility Assurance

Type of Posting: Notice of Intent to Revise
Posting Date: 27–Oct–2017
Targeted Official Date: 1–May–2018
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 in response to the revision of General Chapter <1211> Sterility Assurance.

General Chapter <591> was proposed for comment in Pharmacopeial Forum 43(5) and will appear in USP 41–NF 36. USP has identified numerous monographs that reference General Chapter <1211> and thus require revision to modify these references. These references will be updated when the monographs appear in USP 41–NF 36. A list of the monographs that will be modified can be found here.

All modifications will become official on May 1, 2018 to coincide with the official date of revised General Chapter <1211>.

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 <1211>.

Should you have any questions or comments, please contact Radhakrishna Tirumalai, Principal Scientific Liaison [(301) 816-8339 or rst@usp.org].