FDA Sets New Standards for Heparin, Glycerin

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ROCKVILLE, Md.—In a continuing effort to prevent counterfeit and adulterated medications from reaching American consumers, the U.S. Food and Drug Administration (FDA) is adopting stricter standards for heparin and glycerin—two widely used drug products at the center of recent contamination episodes, HealthDay reported.

The new standards were created by the U.S. Pharmacopeia (USP) Convention, a nonprofit health organization that sets public standards for prescription and over-the-counter medicines and other healthcare products made or sold in the United States.

"These are ongoing changes for our standards for heparin, and for glycerin that might be contaminated with toxins called ethylene glycol and diethylene glycol," said USP Chief Science Officer Dr. Darrell R. Abernethy. "The reason is to protect the public health."

Starting in November 2007, there were hundreds of severe reactions among patients receiving heparin, a blood thinner, and most were patients on kidney dialysis. Some 200 people died from the reactions, Abernethy said.

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