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Heparin Scare Drives Call For API Sources On Drug Labels

This article was originally published in PharmAsia News

Executive Summary

Some physicians and consumers in the United States are urging the FDA to require drug labeling that discloses the origins of the product. The reaction is in response to announcements of deaths that may be connected with heparin blood-thinner made from imported ingredients from China. The pro-labeling groups note that fruits and other commodities are labeled by source, while even a look on drug Web sites usually does not identify the source of drug ingredients, either active or inactive. The FDA requires the name and address only of the manufacturer, packer or distributor, but not the API source, which is treated as confidential. Drug makers say good manufacturing practice requirements, if followed, handle those concerns. (Click here for more - a subscription may be required

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