Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—FDA GUIDANCE NOTICES: Recommendations issued for control of nitrosamine impurities in human drugs, (Sep 6, 2024)

By WK Editorial Staff

The guidance also describes conditions that may introduce nitrosamine impurities.

The FDA is announcing the availability of a final guidance for industry entitled “Control of Nitrosamine Impurities in Human Drugs.” The guidance recommends steps manufacturers of active pharmaceutical ingredients (APIs) and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products. The guidance describes two general structural classes of nitrosamine impurities: small-molecule nitrosamine impurities (i.e., nitrosamine impurities that do not share structural similarity to the API), and nitrosamine drug substance-related impurities (NDSRIs), which share structural similarity to the API and are generally unique to each API (Notice, 89 Fed. Reg. 72408 (Sept. 5, 2024)).

Dates. The announcement of the guidance is published in the Federal Register on September 5, 2024.

FederalRegisterIssuances: FDAGuidanceNotices FDCActNews DrugBiologicNews SafetyNews