The FDA is notifying healthcare professionals and patients about a change to the container and carton labels for heparin products, which will require manufacturers of Heparin Lock Flush Solution, USP and Heparin Sodium Injection, USP to clearly state the strength of the entire container of the medication followed by how much of the medication is in 1 mL.
The labeling change "will eliminate the need for healthcare professionals to calculate the total amount of heparin medication in a product containing more than 1 mL, thereby reducing the risk of miscalculations that may result in medication errors," according to the agency.
The FDA said it supports the United States Pharmacopeia (USP) proposal to revise the labeling section of USP monographs for Heparin Lock Flush Solution, USP and Heparin Sodium Injection, USP to clearly state the total drug strength on the label. This will ensure that labels for heparin products comply with USP’s general requirements for all small-volume injectable products, which currently display the total drug content.
There will be a transition period before and after the official implementation date on May 1, 2013, during which both the current heparin container labels and the revised heparin container labels will be available in the marketplace, the FDA said in its drug safety announcement.