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FDA Finalizes Guidance On Products Containing Heparin

 
• By Elizabeth Orr

US FDA has issued a final guidance document discussing appropriate labeling for products containing heparin. The new rules reflect recent revisions to US Pharmacopeia monographs on heparin solutions.

Guidance word in red keyboard buttons
• Source: Shutterstock

A new guidance document from US FDA provides new recommendations on device labeling and safety testing for heparin-containing products that are intended to reduce the risk of accidental overdoses. The Sept. 20 document aligns FDA guidance with safety-driven revisions to US Pharmacopeia (USP) monographs on heparin sodium, heparin lock flush solution and heparin sodium injections.

Regulators became concerned about the issue after investigations into product-related heparin overdose errors revealed that a major contributing factor had been the way product labels incorporated drug strength information. Additionally,...

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