Heparin Labels Will Be Revised to Reduce Dosing Miscalculations

December 7th, 2012

Heparin Labels Will Be Revised to Reduce Dosing Miscalculations

Kristin J. Kelley, CardioExchange Staff

Heparin manufacturers will now be required to state the total drug strength of the entire container on their labels, the FDA announced on Thursday. The revisions, proposed by the United States Pharmacopeia (USP) in order to avoid medication errors caused by dosing miscalculations, will take effect on May 1, 2013.

The new labels for heparin lock flush solution and sodium injection vials containing more than 1 mL must prominently display the drug strength per total volume, followed by the strength per mL in parentheses. For vials with less than 1 mL of heparin, the strength per fraction of a mL should be the only expression of strength on the label.

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December 7th, 2012