Issue Date: May 8, 2023
Issued by: Center for Drug Evaluation and Research
Topic(s): Compliance,
Status: Final
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 is intended to alert pharmaceutical manufacturers, compounders, repackers, and suppliers to the potential public health hazard of glycerin and other high-risk drug components contaminated with diethylene glycol (DEG) or ethylene glycol (EG). FDA has received and continues to receive (most recently in early 2023) reports about fatal poisonings of consumers who ingested drug products in a liquid dosage form (such as cough, allergy, analgesic, and antiemetic drug products) that were manufactured with DEG- or EG-contaminated components.
Download the Guidance Document
