Revision Bulletin

Fenofibrate Capsules

Posting Date:	May 29, 2009
Official Date:	July 1, 2009
Expert Committee:	Monograph Development–Gastrointestinal, Renal, and Endocrine
Transfers to Accelerated Revision History:	1 May 2010

In accordance with the Rules and Procedures of the 2005-2010 Council of Experts, the Monograph Development–Gastrointestinal, Renal, and Endocrine Expert Committee has revised the Fenofibrate Capsules Monograph. Using a flexible monograph approach, the alternative Assay preparation under the Assay and Test solution under the Related compounds are included in the monograph for the Capsules that meet the requirements of the Dissolution Test 2. The Identification test A is deleted, to address comments that the excipient matrix may interfere with the infrared spectrum of the analyte.

The Fenofibrate Capsules Revision Bulletin supersedes the Monograph in USP 32–NF 27 until it is printed in the USP 33–NF 28, which will be released 1 November 2009 and becomes official 1 May 2010.

Should you have any questions, please contact Elena Gonikberg (301–816–8251 or .

Download the Fenofibrate Capsules Monograph (133KB)