(a) A manufacturer of an investigational drug, biological product, or device may make available and an eligible patient may request access to the manufacturer’s investigational drug, biological product, or device pursuant to this chapter; provided, however, that nothing in this chapter shall be construed to require that a manufacturer make available an investigational drug, biological product, or device to an eligible patient.
(b) A manufacturer may provide an investigational drug, biological product, or device to an eligible patient:
(1) Without receiving compensation; or
(2) With the requirement that the eligible patient pays the costs of, or the costs associated with, the manufacture of the investigational drug, biological product, or device.