Nitrosamine Risk Assessment Date Extended

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FDA moves recommended timeline for API and drug manufacturers to assess impurity risks to March 31, 2021.

API and drug product manufacturers have until March 31, 2021 to assess the risk of nitrosamines in approved or marketed products following FDA’s extension of the recommended timeframe to complete the first of three steps from six to seven months.

On Feb. 24, 2021, FDA announced a revision to its Sept. 3, 2020, guidance for industry, Control of Nitrosamine Impurities in Human Drugs, giving manufacturers more time to complete the first of three steps to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products.

Since 2018, nitrosamines have been found in several commonly prescribed drugs. The guidance recommendations apply to all chemically synthesized APIs, drug products containing chemically synthesized APIs, and drug products at risk due to other factors described in the guidance.

The first step is an assessment of the risk of nitrosamine impurities in APIs, marketed products, and products under approved and pending applications. The risk assessment documents should be retained and be available if requested; the documents do not have to be filed with FDA.


If the manufacturer determines an API or drug product is at risk, they should conduct confirmatory testing for the presence of nitrosamine impurities. Any changes implemented to prevent or reduce nitrosamine impurities in APIs and drug products should be reported to FDA.

Source: FDA