Safety of Chinese prescription drugs may be unwarranted

With Chinese manufacturers poised to increase exports of drug ingredients and perhaps even begin shipping finished drug products to the United States, an article http://pubs.acs.org/cen/business/85/8525bus1.html in Chemical & Engineering News (C&EN), ACS's weekly newsmagazine, questions allegations that foreign-made ingredients often are manufactured in factories that have never been inspected by the U. S. Food and Drug Administration (FDA).

The article, written by Jean-Franois Tremblay, of C&ENAsia-Pacific Bureau, notes that concerns about counterfeit ingredients arose after recent scandals involving Chinese food and drug ingredients. In one incident, media reports said that an over-the-counter cough syrup formulated with a counterfeit Chinese ingredient killed dozens of people in Panama last November.

It is unlikely that counterfeit ingredients could reach prescription medicines sold in the United States because of the high degree of scrutiny that those ingredients receive in China and along their route to the pharmacy shelf, Tremblay reports. However, there is less scrutiny from FDA and other sources for over-the-counter or nonprescription ingredients. FDA only inspects the formulation facilities that make pills, syrups, and other finished products out of ingredients purchased from various suppliers, the article notes.-American Chemical Society

Submitted by harminka on Tue, 2007-06-19 20:36.
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