lucky29
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 Posted: 05/11/07 - 01:14 Post subject: FDA Advises Manufacturers to Test Glycerin for Possible Cont |
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FDA has warned pharmaceutical manufacturers, suppliers, drug repackers, and health professionals who compound medications to make sure that glycerin is not contaminated with diethylene glycol (DEG). Glycerin is a sweetener commonly used in otc and prescription drug products.
Currently, FDA doesn’t believe that the U.S. supply of glycerin is contaminated with DEG, but they are very worried about reports from other countries over the past several years in which DEG-contaminated glycerin had caused human deaths. DEG is a known poison used in antifreeze and as a solvent.
FDA has issuing guidance to industry on how to test glycerin to identify any contamination with DEG before use in the manufacture or preparation of pharmaceutical products. The testing is crucial because of the DEG’s serious nature and this potentially fatal problem.
In September 2006, there was an incident in Panama that involved DEG-contaminated glycerin used in cough syrup that resulted in dozens of hospitalizations for serious injury and more than 40 deaths.
Eleven years ago, in late 1995 and early 1996, at least 80 children died in Haiti due to DEG-contaminated glycerin in acetaminophen syrup.
DEG poisoning has been reported in Argentina, Bangladesh, India, and Nigeria that resulted in hundreds of deaths.
FDA addressed pharmaceutical manufacturers, compounders, repackers, and suppliers, as well as brokers and distributors, and pointed out that all pharmaceutical manufacturing operations must conform to current good manufacturing practice (CGMP).
This guidance is to assure that the use of glycerin that is contaminated with DEG is avoided. |
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