Sec. 4. (a) A manufacturer of an investigational drug, biological product, or device may make available the investigational drug, biological product, or device to a qualified patient.
(b) A manufacturer may do any of the following:
(1) Provide an investigational drug, biological product, or device to a qualified patient without receiving compensation.
(2) Require a qualified patient to pay the costs of or associated with the manufacture of the investigational drug, biological product, or device.
As added by P.L.2-2015, SEC.3.
Structure Indiana Code
Article 42. Regulation of Food, Drugs, and Cosmetics
Chapter 26. Drugs: Investigational Drug, Biological Product, or Device
16-42-26-1. Effect on Clinical Trial Laws; Availability
16-42-26-2. "Investigational Drug, Biological Product, or Device"
16-42-26-3. "Qualified Patient"
16-42-26-4. Availability of Investigational Drug, Biological Product, or Device