Revision Bulletin

Enoxaparin Sodium Monograph

Date Posted: October 31, 2008
Official Date: December 1, 2008
Expert Committee: Biologics Biotechnology—Blood and Blood Products

In accordance with the Rules and Procedures of the Council of Experts, the Biologics and Biotechnology—Blood and Blood Products Expert Committee has revised the Enoxaparin Sodium monograph to align with USP’s newly revised Heparin Sodium monograph due to the prevalence of contaminated heparin products. The revised Enoxaparin Sodium monograph requires that Heparin source material used in the manufacture of Enoxaparin Sodium must comply with the compendial requirements stated in the Heparin Sodium monograph.

This Revision Bulletin is official as of December 1, 2008, and supersedes the monograph that is currently published in USP 31-NF 26 Second Supplement. This revision will be published in print in USP 32-NF 27 First Supplement, which becomes available in February 2009.

Should you have any questions, please contact Anita Szajek, Ph.D. (301–816–8325 or ).

Download the Enoxaparin Sodium monograph (67KB).