Ind. Code ch. 16-42-26

in effect

Ind. Code § 16-42-26-1 Effect on clinical trial laws; availability

Sec. 1. (a) This chapter does not affect IC 5-10-8-15, IC 12-15-5-9.2, IC 27-8-25, or IC 27-13-7-20.2. (b) This chapter does not require a manufacturer to make available any investigational drug, biological product, or device. As added by P.L.2-2015, SEC.3.

Ind. Code § 16-42-26-2 "Investigational drug, biological product, or device"

Sec. 2. As used in this chapter, "investigational drug, biological product, or device" means an investigational or experimental: (1) drug; (2) biological product; or (3) medical device; that has successfully completed Phase I of a federal Food and Drug Administration approved clinical trial, but has not been approved for general use by the federal Food and Drug Administration and remains under investigation in a clinical trial. As added by P.L.2-2015, SEC.3.

Ind. Code § 16-42-26-3 "Qualified patient"

Sec. 3. As used in this chapter, "qualified patient" means a patient who meets the requirements under IC 25-22.5-1-2.1(a). As added by P.L.2-2015, SEC.3.

Ind. Code § 16-42-26-4 Availability of investigational drug, biological product, or device

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.

Ind. Code § 16-42-26-5 Causes of action

Sec. 5. This chapter does not create a cause of action against a manufacturer of an investigational drug, biological product, or device for any harm to a qualified patient resulting from use of an investigational drug, biological product, or device. As added by P.L.2-2015, SEC.3.

Source: Open US Law by Vaquill AI (CC BY 4.0)URL: https://iga.in.gov/laws/2026/ic/titles/16Fetched: 10/17/2026