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Revised US FDA Guidance Calls For Testing More Excipients For DEG And EG

 
• By Bowman Cox

Substantial revision of 2007 DEG guidance comes after hundreds of deaths in seven countries that were linked to diethylene glycol and ethylene glycol adulteration. All containers and all lots of certain additional excipients must now be tested, and many others should be.

Ethylene glycol and diethylene glycol
more deg and eg testing expected • Source: Shutterstock

The US Food and Drug Administration has expanded its guidance on testing certain medicines for diethylene glycol to also test for ethylene glycol, and to test an open-ended list of additional excipients for the deadly adulterants.

The 9 May revision comes after more than 300 people in seven countries, most of them small children, died from DEG/EG adulteration of propylene glycol in late 2022 and early 2023, according to World Health Organization data that the FDA cited in the revised guidance

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