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Gemfibrozil Tablets

Type of Posting: Notice of Intent to Revise
Posting Date: 28–Aug–2020
Targeted Official Date; 01–May–2021, IRA 
Expert Committee: Small Molecules 2

In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 2 Expert Committee intends to revise the Gemfibrozil Tablets monograph.

On the basis of comments received, the Expert Committee proposes to revise the Dissolution test to address solution preparation gaps that were inadvertently introduced as part of monograph redesign and consequent revisions posted in Pharmacopeial Forum 41(3). As part of monograph update, additional changes are also proposed. 

It is anticipated that the proposed revision will be published as a proposed Interim Revision Announcement (IRA) in Pharmacopeial Forum 46(6) [Nov.–Dec. 2020] pursuant to the Rules and Procedures. The comment period for this revision ends on January 31, 2021. In the absence of any adverse comments the proposed IRA will become official on May 1, 2021. 

Should you have any questions, please contact Tsion Bililign, Scientific Liaison (301–816–8286 or