Type of Posting: Notice of Intent to Revise
Posting Date: 26–Aug–2011
Official Date: Revision Bulletin, Date To Be Determined
Expert Committee: Monographs—Small Molecules 4
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 the USP Monographs—Small Molecules 4 Expert Committee intends to revise the Sertraline Tablets monograph as necessary to conform with the newly-approved monograph title 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” found here on the USP website.
It is anticipated that the revision will be published as a Revision Bulletin, pursuant to section 7.02 of the Rules and Procedures. The Revision Bulletin will have a delayed official date of 30 months from the date of posting to allow manufacturers and users to make necessary changes. After the official date, use of the name Sertraline Hydrochloride Tablets will be mandatory. Prior to the official date, the current practice of labeling the article of commerce with the name Sertraline Tablets may be continued.
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).