FDA: Revision of Nitrosamine Guidance and extension of timeframe for risk assessments

On 24 February 2021, the U.S. Food and Drug Administration announced a revision to its September 3, 2020, Guidance for Industry, Control of Nitrosamine Impurities in Human Drugs. The revision extends the recommended timeframe for manufacturers to assess the risk of nitrosamines in active pharmaceutical ingredients (APIs) and drug products from 6 to 7 months.

The guidance recommends a three-step process API and drug product manufacturers should follow to detect, prevent and mitigate nitrosamine impurities in pharmaceutical products. 

The first step is assessing the risk of nitrosamine impurities in APIs, marketed products, and products under approved and pending applications. If an API or drug product is determined to be at risk, manufacturers should perform the second step: conducting confirmatory testing for the presence of nitrosamine impurities. 

To ensure the safety of the U.S. drug supply, the guidance recommends that manufacturers should conclude the first step, the risk assessment of approved or marketed products, within 6 months of guidance publication. Through today’s revision, FDA extends the recommended timeframe for completion of risk assessments to March 31, 2021. Manufacturers do not need to submit risk assessment documents to the agency, but they should retain these documents so they are available if requested. 

Sources:

FDA: Control of Nitrosamine Impurities in Human Drugs – Guidance for Industry

FDA: Information about Nitrosamine Impurities in Medications