FDA issued an Updated Guidance for Nitrosamines

In September 2024, the U.S. FDA released Revision 2 of the document titled "Control of Nitrosamine Impurities in Human Drugs." This updated guidance supersedes the previous version from February 24, 2021, and was published without a comment period, although comments can still be submitted.

The new version comprises six chapters and three annexes, covering:

1. Introduction
2. Background
3. Nitrosamine Impurities and Root Causes of Formation (including sources of impurities in active pharmaceutical ingredients and drug products)
4. Recommendations for Control and Mitigation (including acceptable intake limits and mitigation strategies for both API and drug product manufacturers)
5. Implementation of Recommended Limits (including timelines for risk assessments and reporting changes)
6. Maintaining the Drug Supply

The document, along with additional updates, is available on the FDA website.