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Intent to Revise Heparin Sodium for Injection Monograph

by JMC on May 1, 2012

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—Biologics & Biotechnology 1 Expert Committee intends to revise the labeling section of the USP Heparin Sodium Injection monograph to address the growing safety concern over containers with labels that do not clearly express the total drug strength. The labeling section in the currently official Heparin Sodium Injection monograph, which requires that the label reflect strength per mL, only unless it is a single dose vial, conflicts with the “Strength and Total Volume for Single- and Multiple-Dose Injectable Drug Products” section of General Chapter <1> Injection, which requires that the label reflect strength per total volume as the primary expression of strength followed in close proximity by strength per mL enclosed by parentheses. The proposed revision aligns the USP Heparin Sodium Injection monograph with <1> by removing the conflicting labeling requirement in the monograph.

It is anticipated that the revision will be published as a proposed Interim Revision Announcement for public comment in PF 38(3) on May 1, 2012, with an official date to be determined.

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