Longer US FDA Guidance On Nitrosamine Testing Still Short Of OTC Industry’s Requests

“Control of Nitrosamine Impurities in Human Drugs” guidance, FDA’s third on the subject, adds nearly 20 pages to 2021 guidance document it revises with more extensive discussions of each topic included in the earlier guidance.

The US Food Drug and Administration adds extensive explanations as well as recommendations in its latest guidance on testing for the presence of cancer-causing nitrosamines in active pharmaceutical ingredient but misses the points the US OTC drug industry recommends.

The “Control of Nitrosamine Impurities in Human Drugs” guidance published on 4 September adds nearly 20 pages to the...