US Pharmacopeia announces revised heparin monographs and reference...( Rockville Md. June 23 2008 The U.S....),Health

Rockville, Md., June 23, 2008 The U.S. Pharmacopeial (USP) Convention announces that revised monographs for heparin sodium and heparin calcium in the United States Pharmacopeia (USP) are now available and official on the USP Web site. The revised monographs are accompanied by two new and two updated official USP Reference Standards. These public standards allow any partyand particularly the Food and Drug Administration (FDA) and manufacturersto test heparin sodium and calcium drug substances to assure their quality. All drug manufacturers who market heparin in the United States are required to meet these newly revised standards. The heparin monographs were updated in the interest of public health following the deaths of more than 200 people earlier this year. These deaths are suspected to have resulted from the adulteration of the blood thinner with over-sulfated chondroitin, which is derived from the chemical chondroitin and used in dietary supplements.

The two heparin monographs are posted on the USP Web site at http://www.usp.org/hottopics/heparin.html?hlc. These revisions mark the end of the first stage (Stage 1) of a multi-stage process to revise the monographs. The Stage 1 revision was intended to rapidly address the immediate public health crisis associated with the drug and help ensure an unadulterated supply of heparin by taking proposed methods from the FDA and improving their robustness. The second stage of revision (Stage 2) will seek out additional methods to test for over-sulfated chondroitin and other potential contaminants in heparin. USP co-sponsored a meeting June 19-20, 2008, in Strasbourg, France, with the European Directorate for the Quality of Medicines (the organization that elaborates the European Pharmacopoeia) and the United Kingdom's National Institute for Biological Standards and Control as part of a coordinated, worldwide effort to assure the quality and purity o
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