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The mechanisms behind this increased risk are multifactorial: Iron and Estrogen Synergy: In breast tissue, iron synergizes with estrogen metabolites to generate reactive species, a process intensified in post-menopause when iron stores rise

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The 503A Bulks List is the mechanism that allows this kind of compounding, and a substance only lands on it after a full sequence: nomination, a PCAC recommendation like this one, a comment period, then formal rulemaking through the Federal Register