Control of Nitrosamine Impurities in Human Drugs; Guidance for Industry; Availability

Résumé

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, entitled "Control of Nitrosamine Impurities in Human Drugs." This guidance recommends steps manufacturers of active pharmaceutical ingredients and drug products should take to detect and prevent objectionable 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, ranitidine, nizatidine, and metformin, has made clear the need for a risk assessment strategy to identify and minimize nitrosamines in any pharmaceutical product at risk for their presence.