The confusion is that Rohypnol is a CIV, yet it is not FDA approved. This means all the legalities of CIV drugs apply (though because of the "date rape" phenomenon, there are laws which supercede this). However, a doctor cannot prescribe it because Roche never paid to have clinical trials done. This is most likely because they already make best-selling sedatives, and the stigma plus competition outweighs any need to go through the lengthy, expensive FDA approval process.