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Under Section 503A of the Food, Drug, and Cosmetic Act, traditional compounding pharmacies can only utilize a bulk drug substance if it satisfies one of three explicit criteria: It possesses an official United States Pharmacopeia (USP) or National Formulary (NF) Monograph

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That is arguably a stronger safety model than reading a long written form with no follow-up clarification the clinician can ask clarifying questions in real time but it also means the $250 first-visit fee is committed before the clinician has seen any information

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