Understanding Nitrosamine Contaminants in Pharmaceutical Products

The FDA is dedicated to ongoing evaluation, monitoring, compliance, and quality assurance across all product categories. Our commitment extends to working collaboratively with pharmaceutical companies to ensure that the medications available to the American populace are safe, effective, and of the highest quality. Whenever we discover new or previously unnoticed safety and quality risks, we act promptly to address these issues, as exemplified by our recent actions regarding the identification of nitrosamines in specific medications.

Currently, our testing capabilities are more advanced than ever before, allowing us to pinpoint specific chemical structures and manufacturing processes that could elevate the risk of nitrosamines forming at low levels. Enhanced technology helps us detect even minute traces of impurities within drug products, which may explain the increase in identified instances of low-level nitrosamines. The FDA enforces rigorous safety, effectiveness, and quality standards, and our personnel strive to maintain the utmost safety of the pharmaceutical supply in the United States. In addition, we collaborate closely with global drug regulatory organizations to utilize resources and testing findings from outside the U.S., which can guide our own testing procedures for domestic drugs. As our testing and investigatory efforts continue, alongside those conducted by other international regulatory bodies, it is possible that we will discover low levels of nitrosamines in further drug products.