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New Standards Set for Heparin and Glycerin
Date:2/4/2009

se the new standard to test their products before they can be sold in the United States. The new standard includes a specific chemical identification of heparin that spots the chemicals in the heparin more precisely than was done before, Abernethy said.

Glycerin is a chemical used to sweeten products such as toothpaste and pancake syrup, while ethylene glycol and diethylene glycol are poisonous. Switching ethylene glycol, which is used in antifreeze, as a cheap substitute for glycerin goes back as far as 1937 when more than 107 people were killed in the United States by ethylene glycol used as a liquid base for an antibiotic, Abernethy said.

Recently, there have been cases of ethylene glycol or diethylene glycol contamination in toothpaste from China found in the United States and Panama. The latest case occurred in November, when 34 Nigerian children died after being given a tainted teething drug, according to the FDA.

With that background, the FDA asked the USP to improve the standard for glycerin, to exclude ethylene glycol or diethylene glycol from glycerin, Abernethy said.

Before this change, manufacturers were only required to spot test their products for these chemicals. Now manufacturers will have to test for these chemicals in all the glycerin that comes into their plants, Abernethy said. The new standard takes effect in May.

"The approach that the FDA is using to enforce these standards for heparin and glycerin means that these impurities should not happen again," Abernethy said.

Dr. David L. Katz, director of the Yale University School of Medicine's Prevention Research Center, said he wasn't convinced that these new standards will keep all tainted drugs or other products out of the country.

"In a world of global commerce, perfect defenses against tainted or adulterated drugs are achievable, but at costs few would be willing to pay," Katz said. "It would require high-volume inspection,
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