That’s your FDA for you, operating on on two fears:
(1) The fear that a terminal patient might get deadly complications from a drug;
(2) The fear that someone taking a drug might get a buzz off of it.
Sorry, but it's quite sane, at least from one persepctive.
Consider the case of a patient, whose prognosis is six months to live.
He takes this experimental XYZ-3000, not FDA approved, and keels over in two weeks.
Can't you smell the lawyers salivating over that?