USP Announces New Standards to Protect Patients from Counterfeit and Adulterated Medicines

With counterfeit and adulterated medicines posing an increasing risk to patients in the United States and worldwide, the US Pharmacopeial (USP, Rockville, MD) Convention announced on February 4, new standards for two widely used drug products that have been involved in episodes of adulteration resulting in patient deaths.

The release of these standards, for the blood thinner heparin and the sweetener glycerin, comes on the heels of recent and dangerous incidents involving the two products. More than 200 patients worldwide reportedly died after batches of heparin were adulterated with over-sulfated chondroitin sulfate, which can be derived from the dietary supplement chondroitin and can mimic heparin’s blood-thinning properties. Glycerin, used in many drugs and consumer goods such as cough syrups and toothpaste, has been involved in numerous episodes in which diethylene glycol, a poisonous chemical used in antifreeze, was added either intentionally or accidentally as a lower-cost substitute for glycerin, most recently in Nigeria in 2008.

All manufacturers whose products are used in the United States must comply with these new standards, which are scheduled to become official in May 2009 for glycerin and in August 2009 for heparin (after a public comment period), and are enforceable by FDA. More information on the new heparin and glycerin standards can be found on the USP’s web site.