Type of Posting: Revision Bulletin
Posting Date: 28–Oct–2011
Official Date: 01–Nov–2011
Expert Committee: Monographs—Small Molecules 4
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Sertraline Tablets monograph. The purpose for the revision is to revise the title from Sertraline Tablets to Sertraline Hydrochloride Tablets.
The current monograph became official on May 1, 2011 in USP 34–NF 29 with the title Sertraline Tablets. Based on a request received in June 2011, the Nomenclature, Safety, and Labeling Expert Committee approved the revised title of Sertraline Hydrochloride Tablets. This title change is in accordance with the “Implementation Process for Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations”, available at: http://www.uspnf.com/notices/retired-compendial-notices/usp-nomenclature-policy.
This title revision will have a delayed implementation date of 01 May 2014 corresponding to 30 months from the official date of this revision bulletin, 01 November 2011. This will allow manufacturers and users to make necessary changes. Use of the name Sertraline Hydrochloride Tablets will be mandatory starting 01 May 2014. Prior to 01 May 2014, the current practice of labeling the article of commerce with the name Sertraline Tablets may be continued.
The Sertraline Tablets Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the First Supplement to USP 35–NF 30.
Should you have questions, please contact Dr. Andrzej Wilk, Senior Scientific Liaison to the Nomenclature, Safety, and Labeling Expert Committee (301-816-8305 or aw@usp.org) or Mr. Hari Ramanathan, Associate Scientific Liaison to the Monographs—Small Molecules 4 Expert Committee (301-816-8313 or hr@usp.org).