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# Guide on Drug DNA Reactive Impurities
- URL: https://www.fdaweb.com/guide-on-drug-dna-reactive-impurities/
- Published: 2023-07-25T12:00:00.000Z
- Updated: 2026-09-14T18:46:07.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154946

*Federal Register* notice: FDA is making available a final guidance entitled “M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk,” and two supplemental documents entitled “M7(R2) Addendum: Application of the Principles of the ICH M7 Guidance to Calculation of Compound-Specific Acceptable Intakes” and “M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk Questions and Answers.” The International Council on Harmonization documents are intended to harmonize the considerations for assessing and controlling DNA reactive (mutagenic) impurities. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-07-25/pdf/2023-15645.pdf?ref=fdaweb.com).