FDA Advises Manufacturers to Test Glycerin for Possible Contamination
May 4, 2007--The U.S. Food and Drug Administration (FDA) is warning
pharmaceutical manufacturers, suppliers, drug repackers, and health
professionals who compound medications to be especially vigilant in assuring
that glycerin, a sweetener commonly used worldwide in liquid over-the-counter
and prescription drug products, is not contaminated with diethylene glycol
(DEG). DEG is a known poison used in antifreeze and as a solvent. Today, the
agency is issuing guidance to industry recommending methods of testing glycerin
and other controls to identify any contamination with DEG before use in the
manufacture or preparation of pharmaceutical products.
At the present
time, FDA has no reason to believe that the U.S. supply of glycerin is
contaminated with DEG, though the agency is cognizant of reports from other
countries over the past several years in which DEG-contaminated glycerin has
caused human deaths. FDA is emphasizing the importance of testing glycerin for
DEG due to the serious nature of this potentially fatal problem in combination
with the global nature of the pharmaceutical supply chain and problems that
continue to occur with this kind of contamination in some parts of the global
supply of glycerin.
DEG poisoning is an important public safety issue and
FDA is exploring how supplies of glycerin become contaminated. In addition, FDA
is working with a variety of manufacturing and pharmacist organizations to raise
awareness of this risk and to put into place controls to ensure that this
problem does not happen in the U.S. or elsewhere.
The most recent
incident occurred in Panama in September 2006 and involved DEG-contaminated
glycerin used in cough syrup, which resulted in dozens of hospitalizations for
serious injury and more than 40 deaths. In late 1995 and early 1996, at least 80
children died in Haiti due to DEG-contaminated glycerin in acetaminophen syrup.
Between 1990 and 1998, similar incidents of DEG poisoning reportedly occurred in
Argentina, Bangladesh, India, and Nigeria and resulted in hundreds of deaths. In
1937, more than 100 people died in the United States after ingesting
DEG-contaminated Elixir Sulfanilamide, a drug used to treat infections. This
incident led to the enactment of the Federal Food, Drug, and Cosmetic Act, which
is the nation's primary statute on the regulation of drugs.
FDA reminds
pharmaceutical manufacturers, compounders, repackers, and suppliers, as well as
brokers and distributors, that all pharmaceutical manufacturing operations,
including the re-packaging and re-labeling of ingredients like glycerin, must
conform to current good manufacturing practice (CGMP). The guidance provides
recommendations for complying with CGMP and is intended to help manufacturers,
compounders, repackers, and suppliers avoid the use of glycerin that is
contaminated with DEG and prevent incidents of DEG poisoning.
see also:
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