The FDA announced the availability of an immediately-in-effect final guidance, Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol. This guidance replaces the 2007 guidance and provides advice on how industry can comply with applicable regulatory requirements.
The guidance also outlines recommendations to help pharmaceutical manufacturers, repackers, other suppliers of high-risk drug components, and compounders prevent the use of drug components contaminated with diethylene glycol (DEG) and ethylene glycol (EG).
Throughout history, DEG and EG have occasionally been used inappropriately as inexpensive, odorless, sweet-tasting ingredients in the manufacturing of medications. Most recently, in 2022 and 2023, the World Health Organization (WHO) announced cases of DEG and EG contamination in medications in at least seven countries. Investigations linked the contaminations to more than 300 deaths, most occurring in young children under the age of five.
While the FDA has no indication that any products described in the WHO alerts hae been introduced into the U.S. supply chain, the agency is implementing this guidance document immediately to alert the industry to the potential public health hazard of DEG and EG contamination for certain drug components in excess of the safety limit for drug products. It is critical for safeguarding the quality and safety of medicines that all manufacturers, and others using high-risk drug components to manufacture or prepare drug products, are aware of the importance of detecting and preventing the use of DEG- and EG-contaminated components.
Comments may be submitted to the docket at any time for agency consideration. Identify all comments with the docket number FDA-2023-D-1573.
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