The standards organisation is revising its monographs for Heparin Sodium Injection and Heparin Lock Flush Solution monographs to ensure that labels list the strength per total volume as well as strength per ml.
The USP’s concern is that some containers that only show mg per ml information can be misunderstood by healthcare practitioners, creating risk of potential dangerous overdose.
Roger Williams, USP’s CEO, said: “It is our goal to ensure that USP standards aid practitioners in their delivery of quality care to patients. Particularly in light of the public health emergency involving adulterated heparin in 2008, USP and FDA are continuing to work closely together to help ensure that heparin delivery is as safe and accurate as possible.”
The changes become official on May 1, 2013.