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Glycerin compounded products

May 7, 2007

Audience: Pharmaceutical manufacturers, suppliers, drug repackers, compounding healthcare professionals

[Posted 05/07/2007] FDA warned pharmaceutical manufacturers, suppliers, drug repackers, and healthcare professionals who compound medications using glycerin of the importance of assuring that the glycerin used is not contaminated with diethylene glycol (DEG), a known poison used in antifreeze and as a solvent. Glycerin is a sweetener commonly used worldwide in liquid over-the-counter and prescription drug products. Although FDA has no reason to believe that the U. S. supply of glycerin is contaminated with DEG, it is aware of reports from other countries over the past several years in which DEG contaminated glycerin has caused human deaths. FDA emphases the importance of testing glycerin for DEG due to the serious nature of this potentially fatal problem. FDA issued guidance to industry recommending methods of testing glycerin and other controls to identify any contamination with DEG before using glycerin in the manufacture or preparation of pharmaceutical products.

[May 04, 2007 - News Release - FDA]

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