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The FDA has determined that NAC is excluded from the statutory definition of a dietary supplement under the Federal Food, Drug, and Cosmetic Act, because NAC was authorized as an active pharmaceutical ingredient (for acetaminophen overdose) before it was widely marketed as a supplement

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The lawful basis here is patient-specific 503A personalization for a documented clinical need, confirmed by the February 21, 2025 shortage end and the April 1, 2026 clarification that B12 add-ons alone do not automatically qualify a script