Type of Posting: Notice of Intent to Revise
Posting Date: 05–Oct–2018
Targeted Official Date: 01–May–2019
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 <1090> Assessment of Solid Oral Drug Product Performance and Interchangeability, Bioavailability, Bioequivalence, and Dissolution.
General Chapter <1090> was proposed for comment in Pharmacopeial Forum 42(4) and will appear in USP 42–NF 37. USP has four General Chapters that reference General Chapter <1090> and thus require revision to modify these references. These references will be updated when the General Chapters appear in USP 42–NF 37. A list of the monographs that will be modified can be found here.
All modifications will become official on May 1, 2019, to coincide with the official date of revised General Chapter <1090>.
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 impact they may recognize related to the update of those monographs.
Should you have any questions or comments, please contact William E. Brown, Senior Scientific Liaison (301-816-8380 or firstname.lastname@example.org, or the affected monograph’s liaisons.