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GUIDANCE DOCUMENT

Control of Nitrosamine Impurities in Human Drugs Guidance for Industry September 2020

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2020-D-1530
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

[Updated 2/24/21] This guidance recommends steps manufacturers of APIs and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products. The guidance also describes conditions that may introduce nitrosamine impurities. The recent unexpected finding of nitrosamine impurities, which are probable human carcinogens, in drugs such as angiotensin II receptor blockers (ARBs), ranitidine, nizatidine, and metformin, has made clear the need for a risk assessment strategy for potential nitrosamines in any pharmaceutical product at risk for their presence.

 

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All written comments should be identified with this document's docket number: FDA-2020-D-1530.

 
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