State_Law_Position_Statement_RXE2

RxE2 State Law Position Statement

U.S. State Laws Govern the Dispensing, Labeling, and Counseling Requirements for Investigational New Drugs‍ When conducting clinical trials, sponsors have traditionally looked to 21 C.F.R. §312, and not state law, for guidance. Upon closer examination of state laws, however, it becomes clear that states throughout the country categorize Investigational New Drugs (“INDs”) as prescription drugs.…