(1)  An eligible patient may request, and a manufacturer may make available to an eligible patient under the supervision of the patient’s treating physician, the manufacturer’s investigational drug, biological product or device, which drug, product or device shall be clearly labeled as investigational; provided however, that this chapter does not require that a manufacturer make available an investigational drug, biological product or device to an eligible patient.
(2)  A manufacturer may:
(a)  Provide an investigational drug, biological product or device to an eligible patient without receiving compensation; or
(b)  Require an eligible patient to pay the costs associated with the manufacture of the investigational drug, biological product or device.