RS 40:1300.73: Individualized investigational drugs; facility and manufacturer abilities

A. A manufacturer operating within an eligible facility and in accordance with all applicable Federalwide Assurance for the Protection of Human Subjects laws and regulations may make available an individualized investigative treatment and an eligible patient may request an individualized investigational drug, biological product, or device from an eligible facility or manufacturer operating within an eligible facility in accordance with this Part. This Part shall not require a manufacturer to 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 all 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 investigational drug, biological product, or device.