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Modafinil Tablets

Type of Posting: Revision Bulletin

Posting Date: 26–Sep–2014

Official Date: 01–Oct–2014

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 Modafinil Tablets monograph. The purpose for the revision is to add Dissolution Test 3 for a drug product approved by the FDA.

The Modafinil Tablets Revision Bulletin supersedes the currently official monograph.  The Revision Bulletin will be incorporated in the First Supplement to USP 38–NF 33.

Should you have any questions, please contact Mary P. Koleck (301-230-7420 or mpk@usp.org).