From out of left (well, really, right) field. The lack of FDA approval, by itself, doesn’t mean anything.
Five justices of the Supreme Court conclude, in the context of a death penalty appeal, that the fact that the state got a drug to be used in the execution from an overseas source that was not FDA-approved, doesn’t – by itself – establish that there’s likely to be anything wrong with the drug:
There is no evidence in the record to suggest that the drug obtained from a foreign source is unsafe. The district court granted the restraining order because it was left to speculate as to the risk of harm. But speculation cannot substitute for evidence that the use of the drug is sure or very likely to cause serious illness and needless suffering. There was no showing that the drug was unlawfully obtained.
Brewer v. Landrigan, No. 10-416, 562 U.S. ___ (U.S. Oct. 26, 2010) (citations omitted) (per curiam).