(a) A manufacturer of an investigational drug, biological product, or device may make available such drug, product, or device to eligible patients. Nothing in this Act shall be construed to require a manufacturer to make available any drug, product, or device. (b) A manufacturer may: (1) provide an investigational drug, biological product, or device to an eligible patient without receiving compensation; or (2) require an eligible patient to pay the costs of or associated with the manufacture of the investigational drug, biological product, or device. product, or device to an eligible patient without receiving compensation; or or associated with the manufacture of the investigational drug, biological product, or device.
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