USP Announces New Heparin Labeling Requirement

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The U.S. Pharmacopeial Convention (USP) has revised its current standards on heparin labeling requirements to address safety concerns about the expression of drug strength.

The labeling sections for the official Heparin Sodium Injection and Heparin Lock Flush Solution monographs are being revised to ensure compliance with General Chapter <1> Injections. It requires that the label reflect strength per total volume as the primary expression of strength followed in close proximity by strength per milliliter (eg, 30,000 USP Units/30mL [1000 USP Units/mL]).

In July 2010, the FDA referred to data indicating that containers labeled only with product strength statements written as “mg per mL” are often misunderstood by health care practitioners as total drug content statements. These medication errors could results in improper dosing with serious outcomes, even death.

The entire process began with Interim Revision Announcements for Heparin Sodium Injection (May 1, 2012) and for Heparin Lock Flush Solution (September 4, 2012). The revised standards will become official on May 1, 2013, and posting of the official monographs will occur on January 25, 2013.

For more information call (800) 227-8772 or visit www.usp.org/usp-nf/hot-topics/heparin.

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