36-1332. Individualized investigational treatment; availability

A. A manufacturer operating within an eligible facility and pursuant to all applicable federalwide assurance regulations may make available to an eligible patient an individualized investigational treatment.  An eligible patient's physician may request an individualized investigational drug, biological product or device from an eligible facility or manufacturer operating within the eligible facility. This article does not require that a manufacturer make available an individualized investigational drug, biological product or device to an eligible patient.

B. An eligible facility or manufacturer operating within an eligible facility may do both of the following:

1. Provide an individualized investigational drug, biological product or device to an eligible patient without receiving compensation.

2. 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.