1. (1) A manufacturer of an investigational drug, biological product, or device may make the drug, product, or device available to a patient who has requested the drug, product, or device pursuant to this part.

2. (2) The manufacturer may:

   1. (a) provide an investigational drug, biological product, or device to a patient without receiving compensation; or
   2. (b) require a patient to pay the costs of or the costs associated with the manufacture of the investigational drug, biological product, or device.
3. (3) A manufacturer is not required to make an investigational drug, biological product, or device available to a patient.

History: En. Sec. 3, Ch. 135, L. 2015; amd. Sec. 2, Ch. 413, L. 2023.