USP updates standards for heparin

USP 100x100 USP updates standards for heparinA recent report in Huliq News documents efforts by the U.S. Pharmacopeial (USP) Convention to improve the safety of blood thinner heparin by revising its written and physical standards for the drug. The update comes at the request of the U.S. Food & Drug Administration (FDA) following a 2008 public health crisis when more than 200 people died after being administered contaminated heparin.

According to its web site, U.S. Pharmacopeia is an official public standards-setting authority for all prescription and over-the-counter medicines and other health care products manufactured in the United States. It is a non-governmental, not-for-profit public health organziation staffed by independent, volunteer experts.

USP Chief Executive Officer Roger L. Williams, M.D., was quoted as saying, “Stronger methods for detecting contaminants have been thoroughly assessed and incorporated into the new test methods, and the new physical reference standards are specific to these methods.”

According to the Huliq News report, these newest changes in standards were the topic of discussion at the third International Heparin Workshop, which was held at USP headquarters in Rockville, Maryland, this summer. The Workshop was co-sponsored by USP, the British National Institute of Biological Standards and Control (NIBSC), and the European Directorate for the Quality of Medicines (EDQM).

It is hoped the upgraded standards will improve patient and physician confidence in heparin products.

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