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How FDA evaluates essentially a copy: Same route of administration: If the compounded preparation is given by the same route as the commercially available product (e.g., subcutaneous injection), this factor supports an essentially a copy finding
NAFLD is associated with metabolic syndromes and the incidence of NAFLD has increased over time [4, 5]
Federal law (the Medicare Modernization Act) explicitly prohibits Part D from covering medications used for weight loss or anorexia, regardless of medical necessity
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