The Johns Hopkins Clinic for Public Health Law and Policy State Department of Corrections Are violating FDA's Investigational New Drug Regulations by Experimenting With Lethal Injection Drugs May 5, 2014

Here is an except from this paper:

In its IND regulations, FDA has defined ‘clinical investigation’ to mean “any

experiment in which a drug is administered or dispensed to, or used involving, one or

more human subjects,” and it further defines ‘experiment’ in this context to mean

“any use of a drug except for the use of a marketed drug in the course of medical

practice.”5 This regulatory definition fits perfectly the experiments some DoCs have

been conducting, especially in light of the recent holding in the Southern District of

Ohio (as quoted above).
read the entire paper here