(a) A manufacturer of an investigational drug, biological product, or device may make available, and an eligible patient may request, the manufacturer's investigational drug, biological product, or device under this part; provided, that this part does not require that a manufacturer make available an investigational drug, biological product, or device to an eligible patient.
(b) A manufacturer may do all of the following:
(1) Provide an investigational drug, biological product, or device to an eligible patient without receiving compensation; and
(2) Require an eligible patient to pay the costs of, or the costs associated with, the manufacture of the investigational drug, biological product, or device.
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