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  1. Drug Safety and Availability

Information about Nitrosamine Impurities in Medications

What You Should Know about Nitrosamine Impurities

FDA issues guidance,“Control of N-Nitrosamine Impurities in Human Drugs”

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.

Update [2/24/2021] To ensure the safety of the U.S. drug supply, the guidance recommends that manufacturers should conclude the risk assessment of approved or marketed products, the first of three steps manufacturers should follow to mitigate nitrosamine impurities in their products, within 6 months of publication of the guidance. Through today’s revision to the guidance, FDA extends the recommended timeframe for completion of risk assessments to March 31, 2021. Manufacturers do not need to submit risk assessment documents to the agency, but they should retain these documents so that they are available if requested

[9/1/2020] FDA is announcing the availability of a guidance for industry, entitled “Control of N-Nitrosamine Impurities in Human Drugs.” This guidance recommends steps manufacturers of active pharmaceutical ingredients and drug products should take to detect and prevent objectionable levels of nitrosamine impurities in pharmaceutical products. The guidance also describes conditions that may introduce nitrosamine impurities.

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