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# Guidance on Assessing DNA Reactive (Mutagenic) Impurities
- URL: https://www.fdaweb.com/guidance-on-assessing-dna-reactive-mutagenic-impurities/
- Published: 2018-03-13T12:00:00.000Z
- Updated: 2026-09-14T23:29:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140974

*Federal Register* notice: FDA has made available a guidance entitled “M7(R1): Assessment and Control of Deoxyribonucleic Acid (DNA) Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.” The International Council for Harmonization document updates and replaces a 5/2015 guidance under the same title. The new guidance provides recommendations on acceptable intakes, or permissible daily exposures, derived for some chemicals that are considered to be mutagens and carcinogens. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-05118.pdf?ref=fdaweb.com).