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# Guide on Controlling Nitrosamine Impurities
- URL: https://www.fdaweb.com/guide-on-controlling-nitrosamine-impurities/
- Published: 2020-09-03T12:00:00.000Z
- Updated: 2026-09-14T16:27:41.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147578

*Federal Register* notice: FDA has made available a final guidance entitled *Control of Nitrosamine Impurities in Human Drugs*. The document recommends steps that active pharmaceutical ingredient and drug product manufacturers should take to detect and prevent objectionable levels of nitrosamine impurities in pharmaceutical products. It also describes conditions that may introduce nitrosamine impurities. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-09-03/pdf/2020-19519.pdf?ref=fdaweb.com).