1. (1) A manufacturer operating within an eligible facility and in accordance with applicable federal law may make available to an eligible patient, and an eligible patient may request, the manufacturer's individualized investigational drug, biological product, or device from the eligible facility or manufacturer operating within the eligible facility.

2. (2) A manufacturer of an individualized investigational drug, biological product, or device may:

   1. (a) Provide the individualized investigational drug, biological product, or device to an eligible patient without receiving compensation; or
   2. (b) Require an eligible patient to pay the costs of, or the costs associated with, the manufacture of the individualized investigational drug, biological product, or device.
3. (3) Nothing in this part 2 requires a manufacturer of an individualized investigational drug, biological product, or device to make the individualized investigational drug, biological product, or device available to an eligible patient.
4. (4) If a patient dies while being treated with an individualized investigational drug, biological product, or device, the patient's heirs are not liable for outstanding debt related to the treatment, including costs attributed to lack of insurance coverage for the treatment.

Source: L. 2025: Entire part added, (HB 25-1270), ch. 211, p. 956, § 5, effective May 19.