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# FDA Extends Nitrosamine Risk Assessment Timeframe
- URL: https://www.fdaweb.com/fda-extends-nitrosamine-risk-assessment-timeframe/
- Published: 2021-02-24T12:00:00.000Z
- Updated: 2026-09-14T16:48:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148740

FDA has revised its 9/1/20 guidance, *Control of N-Nitrosamine Impurities in Human Drugs*, to extend to 3/31 from 3/1 the recommended timeframe for completing risk assessments. FDA [says](https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications?utm%5Fmedium=email&utm%5Fsource=govdelivery) manufacturers do not need to submit risk assessment documents to the agency, but should retain them so they are available if requested.

The original guidance recommended steps manufacturers of active pharmaceutical ingredients and drug products should take to detect and prevent objectionable levels of nitrosamine impurities in pharmaceutical products.