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Compounding pharmacies operating under 503A are regulated by state boards of pharmacy and must follow specific rules: Compound only on a valid prescription for an individual patient Source active pharmaceutical ingredients (API) from FDA-registered facilities Follow USP 797 sterile compounding standards Limit to medications listed on FDAs Bulks List or covered under specific exemptions (drug shortage list, medical-need customization) Submit to state board oversight, including inspection and quality reporting Compounding pharmacies that meet these requirements are legitimate prescription pharmacies

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