Heparin labels updated to clarify drug strength

Medication labels for Heparin Lock Flush Solution, USP and Heparin Sodium Injection, USP are now required to clearly state the strength of the entire container followed by how much of the medication is in 1 milliliter (mL), the FDA announced in a drug safety communication.

"These modifications will eliminate the need for health care 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," the agency stated.

This ensures that heparin labeling complies with the United States Pharmacopeia (USP) general requirements for all small-volume injectable products. USP issued the requirements after it became aware that containers labeled with the strength per mL were often misunderstood as the total drug content, which could result in dosing errors with serious consequences to patients.

Current Heparin Label

Revised Heparin Label

During the transition period prior to the May 1, 2013 implementation deadline, clinicians should be aware that both the current heparin container labels and the revised heparin container labels will be available in the marketplace.

"To minimize the potential for medication errors, users should consider separating the supplies of 'current' and 'revised' labeled heparin, and use all of the supplies of the 'current' heparin before using products with the 'revised' container label," the FDA advises.

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