Presenter Lynn urges drugmakers to use FDA's nitrosamine web page and follow current AI-limit tables

Lynn, a presenter, told attendees the nitrosamine web page is “the central place for FDA to provide…the update of the current FDA thinking about the nitrosamine controls,” and urged firms to check it regularly to assess impacts on products and applications.

She outlined three recommended AI-limit tables on the page: Table 1 (theoretical AI limits using a CPC approach for nitrosamines without reliable toxicology data), Table 2 (compound-specific AI limits based on available TOX/TOPS data or suitable surrogates), and Table 3 (interim AI limits intended only for marketed medically necessary products when immediate compliance with Table 1 or Table 2 limits could cause drug shortages). Lynn emphasized that AI limits are safety thresholds, not measurements of observed levels, and that listing on the web page does not mean a nitrosamine will necessarily be present in every product.

The presenter said when a nitrosamine moves from Table 1 to Table 2, “the recommended AI limit in table 2 should be applied,” replacing the prior Table 1 value. She also warned that interim (Table 3) limits are temporary regulatory discretion to prevent shortages and cannot be used as permanent specification limits or to justify permanent product specifications. Firms were advised to implement sustainable mitigation strategies rather than rely on interim releases.

The guidance, Lynn said, is updated frequently and can be implemented immediately; firms should apply the most recent AI limits and follow the web page instructions for submissions, progress updates and data requests.