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Hernandez AF, Green JB, Janmohamed S, D’Agostino RB, Sr., Granger CB, Jones NP, Leiter LA, Rosenberg AE, Sigmon KN, Somerville MC, Thorpe KM, McMurray JJV, Del Prato S

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A compounded product is considered “essentially a copy” if it has the same API as a commercially available drug in the same, similar, or easily substitutable strength, and can be used by the same route of administration, unless the prescriber documents a patient-specific change that produces a significant difference