Type of Posting: Notice of Intent to Revise
Posting Date: 25–Jan–2019
Targeted Official Date: 01–Mar–2019, Revision Bulletin-Postponement
Expert Committee: General Chapters-Statistics
In accordance with section 7.04 (c) of the 2015–2020 Rules and Procedures of the Council of Experts, this is to provide notice that the General Chapters-Statistics Expert Committee intends to revise General Chapter <1099> Limit on Number of Large Deviations When Assessing Content Uniformity in Large Samples.
In light of ongoing discussions regarding the alignment of <1099> with stakeholder expectations, and to optimize the chapter’s utility to the industry, the Expert Committee intends to postpone the official date of this General Chapter pending further stakeholder engagement. Future proposed revisions to the General Chapter will appear in Pharmacopeial Forum. It is anticipated that the postponement of the General Chapter will be published as a Revision Bulletin on February 22, 2019.
Please note that because the Second Supplement to USP 41–NF 36 was not available on the regular posting date of June 1, and to give users additional time to adjust to the new online platform before implementation, the official date of the Second Supplement to USP 41–NF 36 was delayed by three months from December 1, 2018 until March 1, 2019. For more information on the launch of the new USP–NF Online Launch please see this notice.
Should you have any questions, please contact Will Brown, Senior Scientific Liaison (301–816–8380 or email@example.com).