> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Draft Guide on Drug Mutagenic Impurities
- URL: https://www.fdaweb.com/draft-guide-on-drug-mutagenic-impurities/
- Published: 2020-09-30T12:00:00.000Z
- Updated: 2026-09-14T16:30:50.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147767

*Federal Register* notice: FDA has made available a draft guidance entitled *M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk — Questions and Answers.* The document provides a practical approach that is applicable to the identification, categorization, qualification, and control of mutagenic impurities to limit potential carcinogenic risk. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-09-29/pdf/2020-21461.pdf?ref=fdaweb.com).