Sec. 4. (a) A manufacturer of an investigational drug, biological product, or device may make available the investigational drug, biological product, or device to a qualified patient. (b) A manufacturer may do any of the following: (1) Provide an investigational drug, biological product, or device to a qualified patient without receiving compensation. (2) Require a qualified patient to pay the costs of or associated with the manufacture of the investigational drug, biological product, or device.
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