Essential medicines and health products

Monographs for Heparin calcium and Heparin sodium in The International Pharmacopoeia

Rapid Revision

Since February 2008 national drug regulatory authorities (DRAs) and WHO have issued international alerts, warning letters to health professionals and information about recalls regarding contaminated heparin sodium injections.

In line with the action taken by other pharmacopoeias with respect to heparin monographs, rapid revision of the monographs in The International Pharmacopoeia for Heparin calcium and Heparin sodium has been adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations. This WHO Expert Committee, together with the one on Biological Standardization will review the scientific work being carried out jointly by interested parties including the WHO Collaborating Laboratory for Biological Standards in London, UK. The need for further revision of the monographs will be examined.

Meanwhile, the following amendments were adopted at the Forty-third WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2008 for inclusion in the Second Supplement to the Fourth Edition of The International Pharmacopoeia (in preparation):

General Notices, General requirements
Heparin Calcium
Heparin Sodium
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