Executive Summary

FDA in March stopped requiring heparin manufacturers to provide the agency monthly updates on heparin test results. Last year, FDA established screening methods involving capillary electrophoresis and proton nuclear magnetic resonance to identify and remove from the market heparin that had been adulterated with oversulfated chondroitin sulfate. The agency asked all manufacturers to perform the tests and provide it with monthly updates on their results. Although FDA is no longer requiring the updates, it reminded manufacturers to continue notifying it of any positive results within three days of testing. Noting that the U.S. Pharmacopeia has added the new testing methods to its heparin monograph, FDA said its inspection program will monitor adherence to the appropriate testing regimen