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Ensuring Product Safety: U.S. FDA Guidance on Testing High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol

Quality Matters

FDA guidance is an update to a guidance from 2005 and identifies not only DEG but also EG as potential contaminants in high-risk components including those listed in the title. Compliance with DEG and EG limits when specified in an applicable USP-NF monograph is crucial for the quality and safety of compounded drug products.