1. 1. A manufacturer of an investigational drug, biological product, or device or a manufacturer operating within, and in compliance with all requirements applicable to, an eligible facility may make available, and an eligible patient, as applicable under section 144E.2, subsection 2, paragraph “a” or “b”, may request from a manufacturer of an investigational drug, biological product, or device, or a manufacturer operating within, and in compliance with all requirements applicable to, an eligible facility, the manufacturer’s investigational drug, biological product, or device, or the manufacturer’s individualized investigational treatment under this chapter. This chapter does not require a manufacturer of an investigational drug, biological product, or device, or of an individualized investigational treatment to provide or otherwise make available the investigational drug, biological product, or device, or the individualized investigational treatment to an eligible patient.

2. 2. An eligible facility, or a manufacturer described in subsection 1, that is in compliance with all applicable requirements, may do any of the following:

   1. a. Provide an investigational drug, biological product, or device, or an individualized investigational treatment to an eligible patient, as applicable under section 144E.2, subsection 2, paragraph “a” or “b”, without receiving compensation.
   2. b. Require an eligible patient, as applicable under section 144E.2, subsection 2, paragraph “a” or “b”, to pay the costs of, or the costs associated with, the manufacture of the investigational drug, biological product, or device, or the individualized investigational treatment.

Section amended

2017 Acts, ch 130, §3; 2025 Acts, ch 80, §2; 2025 Acts, ch 159, §8