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

11 May 2023

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...