The United States Pharmacopeia (USP) drug substance monograph for Heparin Sodium, and drug product monographs for Heparin Lock Flush Solution and Heparin Sodium Injection, recently have undergone several revisions following serious and fatal events related to the use of heparin sodium products. Investigation of heparin product overdose errors identified the expression of drug strength in the labels as a major contributing factor in these errors. This guidance document addresses these safety concerns by clarifying new expectations for labeling with regard to the revised heparin USP monographs, as well as outlining safety testing
In addition, the outbreak of serious and often fatal events due to heparin contamination with oversulfated chondroitin sulfate (OSCS) in 2008 led the USP to include in its drug substance monograph additional testing of heparin sodium to ensure its quality and purity. This guidance also outlines use of conformance to the monographs in premarket submissions, namely testing specified in the current USP monographs and testing and documentation recommendations contained in the guidance document “Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality.”
Note that recommendations made in this guidance reflect FDA’s current position on this issue and may change in the future as new scientific information or new detection methods become available. FDA intends to revise this guidance document as needed to reflect any additional revisions to these USP heparin monographs.
For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database Web site at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm