In addition to formulation changes described in the update, the FDA previously suggested a mitigation strategy of qualifying suppliers taking into account potential nitrite impurities across excipient suppliers and excipient lots.

The update also states that the FDA will consider meeting requests to discuss innovative mitigation strategies with prospective applicants or manufacturers. Applicants may also choose to submit formulation changes through supplements or amendments to their applications without scheduling a meeting with the agency; any manufacturer, including non-application drug manufacturers, may implement any formulation changes in accordance with appropriate good manufacturing practice regulations and related guidance.

Additionally, the CDER recommends applicants or manufacturers interested in meeting with the agency prepare a comprehensive meeting package with the appropriate regulatory and scientific data using the above or other novel approaches to reduce the risk of nitrosamine impurities in drug products in accordance with existing guidance.

US FDA Suggests Adding Antioxidants To Drug Formulations To Mitigate Nitrosamine Risks

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