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Interested parties have expressed concern that compounded formulations of immunosuppressive drugs (for example, a liquid formulation of an immunosuppressive drug not commercially available from a manufacturer but prepared by a pharmacist) are not included in the immunosuppressive therapy benefit because these formulations are not approved by the FDA (that is, FDA does not review these drugs to evaluate their safety, effectiveness, or quality before they reach patients [316] ), which is a regulatory requirement under the current benefit