Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs)

September 5, 2023
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Recently, the U.S. Food and Drug Administration (FDA) made a notable advancement in protecting public health by releasing a fresh set of guidelines, “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 in products under review by the FDA.

It is worth stressing that the FDA has established the following deadlines to apply the recommendations addressed in the guideline:

  • FDA recommends that if NDSRIs were not considered in previous risk assessments, manufacturers and applicants reevaluate the risk within 3 months of publication of this guidance, with a recommended completion date by November 1, 2023
  • To enable manufacturers and applicants to complete the three-step mitigation strategy based on increased awareness of NDSRIs, FDA recommends conclusion of NDSRI confirmatory testing of drug products and submission of required changes in drug applications by August 1, 2025


You can have a look at the complete document here: FDA Guidance on recommended acceptable intake limits for Nitrosamine Drug Substance-Related Impurities

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