Nitrosamine Control Guidance Out

FDA has issued a guidance, Control of Nitrosamine Impurities in Human Drugs, recommending steps manufacturers of active pharmaceutical ingredients (APIs) and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in drug products. The document also describes conditions that may introduce nitrosamine impurities.

FDA says the guidance’s recommendations apply to all chemically synthesized APIs, drug products containing chemically synthesized APIs, and drug products at risk due to other factors described in the guidance, and not just to drug products that have been identified in FDA safety announcements.

The guidance includes Introduction, Background, Recommendations, Maintaining the Drug Supply, Reporting Changes to FDA, and appendices on Additional Resources and FDA Recommendation of the Acceptable Intake.

In a statement, FDA commissioner Stephen Hahn says the guidance “will assist manufacturers in preventing unacceptable levels of nitrosamines in drugs.”