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How The US FDA Is Checking For Adequate Controls Against DEG/EG Ingredient Substitution

 
• By Bowman Cox

Agency has increased its efforts to protect the US market from the diethylene glycol and ethylene glycol adulteration linked to hundreds of deaths in seven countries with testing, remote records requests, inspections, import alerts and more. Manufacturing quality compliance director Francis Godwin stresses importance of testing every container, while sharing tips for simplifying the task.

Diethyelen glycol and ethylene glycol adulterants
why so much deg/eg testing is needed • Source: Shutterstock

The US Food and Drug Administration dove into action after several hundred deaths in multiple countries were linked in recent months to medicines adulterated by diethylene glycol and ethylene glycol substitution, and heightened oversight can be expected to continue.

The DEG/EG adulteration “is probably the scariest thing that we’re seeing right now in the excipient space,” said Francis Godwin, director of the Office of Manufacturing Quality in the FDA’s...

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