C.R.S. § 12-280-131: New drugs - when sales permissible - exemptions.

(1) No person shall sell, deliver, offer for sale, hold for sale, or give away any new drug not authorized to move in interstate commerce under appropriate federal law.

(2) This section does not apply:

(a) To a drug that is plainly labeled to be for investigational use only and that is:

(I) Intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs; or

(II) Reviewed by an institutional review board;

(b) To a compounded drug or device if the compounding of the drug or device is undertaken in accordance with applicable federal and state law, including the standards recognized by the FDA for state-licensed resident pharmacies, licensed resident 503B outsourcing facilities, state-licensed nonresident pharmacies, and nonresident 503B outsourcing facilities, including incorporated United States pharmacopeia sterile or nonsterile processing standards.