IC 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.