(a) A manufacturer of an investigational drug, biological product, or device may make available, and an eligible patient may request, the manufacturer’s investigational drug, biological product, or device under this part; provided, that this part does not require that a manufacturer make available an investigational drug, biological product, or device to an eligible patient.
Terms Used In Tennessee Code 63-6-303
Eligible patient: means an individual who meets all of the following conditions:(A) Has an advanced illness, attested to by the patient's treating physician and confirmed by a second physician. See Tennessee Code 63-6-302
(b) A manufacturer may do all of the following:
(1) Provide an investigational drug, biological product, or device to an eligible patient without receiving compensation; and(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.
