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  1. Drug Safety and Availability

Information about Nitrosamine Impurities in Medications

What You Should Know about Nitrosamine Impurities

Update [08/04/2023] FDA issued a new guidance for immediate implementation, “Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs),” which provides drug manufacturers and applicants with a recommended framework for a risk-based safety assessment of NDSRIs that could be present in approved and marketed drug products, as well as products under review by the FDA. 

Update [11/18/2021] FDA provides information to industry on possible mitigation strategies to reduce the risk of nitrosamine drug substance related impurities (NDSRI) in drug products.


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