FDA Releases Guidance on Contaminated Glycerin

The FDA is warning manufacturers, compounding pharmacies, repackers and suppliers to conduct appropriate tests to ensure that contaminated glycerin is not used in pharmaceutical liquids, according to an agency guidance document published in the Federal Register.

Glycerin is used in manufacturing and compounding pharmaceutical syrups. Recent cases of the product being contaminated with diethylene glycol (DEG) led the agency to release the guidance. DEG is a sweet-tasting poison used in automobile antifreeze.

DEG poisoning outbreaks occurred in Panama in October 2006, and in Haiti in 1995 and 1996, the FDA said. Hundreds of child deaths in Argentina, Bangladesh, India and Nigeria resulted from DEG poisoning between 1990 and 1998, according to the agency.

The contaminations occurred because manufacturers of certain cough syrups did not conduct full identity tests on the raw material and relied on certificates of analysis submitted by glycerin suppliers that did not contain a chain of custody for the ingredient, the FDA said.

The agency is recommending manufacturers perform appropriate tests to prevent further contamination. “It is critical that all manufacturers and others using glycerin to manufacture or prepare drug products be aware of the importance of properly testing glycerin to detect DEG contamination,” the FDA said.

The tests, in accordance with cGMP regulations, are required to identify each component of a drug product, the FDA said. The recommended tests include limit and identity tests listed in the U.S. Pharmacopeia monograph for glycerin, or a thin-layer chromatography testing method.