Supply of heparin further secured

October 9, 2009

A second round of revised quality standards for heparin became effective recently, the U.S. Pharmacopeial (USP) Convention has announced.

A second round of revised quality standards for heparin became effective recently, the U.S. Pharmacopeial (USP) Convention has announced.

Working closely with the Food and Drug Administration (FDA), the pharmaceutical industry, and other regulatory and scientific bodies, USP started initial revisions in 2008 after adverse reactions and deaths resulted from heparin intentionally adulterated with over-sulfated chondroitin sulfate (OSCS).

OSCS is a less costly substance that can mimic the blood-thinning properties of heparin. The immediate public health crisis was addressed by the first stage of quality revisions released by USP in June of 2008, but a thorough modernization of the existing heparin monographs was needed to ensure the continuing quality of heparin. Those second stage tests and accompanying reference materials that enable manufacturers to compare their products to a proven standard were first announced by USP in February of 2009.

Following a period of public comment, the standards are now enforceable in the United States by FDA. “It has been gratifying to see so many dedicated scientists and regulators collaborating successfully and in an expedited manner in the interest of protecting patients,” said Roger L. Williams, MD, chief executive officer of USP.

As part of the second-stage revisions, USP has harmonized dosage measurement units with those established by the World Health Organization (WHO). This harmonization means a more uniform worldwide standard. To give manufacturers and practitioners the opportunity to fully understand the revisions, FDA and industry will conduct communications outreach to clinicians and hospitals.

USP and FDA are now starting work on a third stage of revisions to the heparin standards, which will involve laboratory research designed to bring even greater sensitivity and precision to the tests and standards used to help ensure drug quality.