The US Food and Drug Administration stood its ground when confronted recently by trade associations for manufacturers of brand, generic and over-the-counter drug products over the difficulty of following agency guidance on reducing cancer risk from nitrosamine impurities to acceptable levels.
Key Points
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Compliance will be costly and resource intensive.
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Deadline extensions are unlikely.
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Supply chain partners must help assess nitrosamine risks.
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Limits will have to be set based on lifetime use, even for short-duration or single-use medicines
The agency did, however, leave an opening for continuing dialogue over possibly further extending compliance deadlines set forth in the September 2020 guidance,
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