New Guidance Effective Immediately for Testing of Glycerin, Propylene, Other High Risk Drug Components

The new guidance from FDA is set 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). This comes from the frequent reports to FDA about fatal poisonings of consumers who ingested drug products in a liquid dosage form, like cough or allergy drug products, that were manufactured using DEG- or EG-contaminated components.

Further, the guidance is to provide information on compliance with applicable regulatory requirements and recommendations to help pharmaceutical manufacturers, repackers, other suppliers of high-risk drug components, and compounders prevent the use of glycerin and other high-risk drug components that are contaminated with DEG or EG.

Source: FDA