Ensuring Your Products Are Compliant Before The Nitrosamine Impurities Deadline

In August 2023, the FDA released its guidance on nitrosamine contamination, Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs). This guidance set a November 1, 2023, deadline for risk assessment updates and an August 1, 2025, deadline for all drug manufacturers and market authorization holders to comply fully with the NDSRI limits set. This affects no small portion of the industry: about 30% of approved active pharmaceutical ingredients (APIs) are susceptible to nitrosamine formation. Thus, drug makers now are on the clock to correct issues that may arise with current commercial products. Issues with in-development APIs must be addressed before filing.

The FDA’s guidance sets acceptable limits for the presence of nitrosamine and enforces implementation of a control strategy, holding both applicants and manufacturers accountable together. Adare’s work directly informs a customer’s response to the requirement for a control strategy that keeps the product within the acceptance limits.