Colorado § 12-280-131 - New drugs - when sales permissible - exemptions.
Full text of Colorado Colorado Revised Statutes § 12-280-131 — New drugs - when sales permissible - exemptions., with citation guidance and answers to common questions.
§ 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.
Source: L. 2019: Entire title R&RE with relocations, (HB 19-1172), ch. 136, p. 1479, § 1, effective October 1. L. 2026: (2) amended, (HB 26-1262), ch. 304, p. 1740, § 4, effective June 2.
Editor's note: (1) This section is similar to former § 12-42.5-128 as it existed prior to 2019.
(2) Section 5 of chapter 304 (HB 26-1262), Session Laws of Colorado 2026, provides that the act changing this section applies to conduct occurring on or after June 2, 2026.
Cross references: For the short title ("Colorado Patient Access and Compounding Clarity Act") and the legislative declaration in HB 26-1262, see sections 1 and 2 of chapter 304, Session Laws of Colorado 2026.
Source: official Colorado text · Last verified 2026-08-27
Frequently Asked Questions About Colorado § 12-280-131
What does Colorado Revised Statutes § 12-280-131 cover?
Section 12-280-131 ("New drugs - when sales permissible - exemptions.") is part of the Colorado Revised Statutes, the codified statutory law of Colorado. It sets out the legal rule or procedure described in the text above. Statutes are amended regularly, so always verify against the official source.
How do I cite Colorado § 12-280-131?
A common citation format is "Colorado Revised Statutes § 12-280-131" (Colorado). Legal writing may require the code abbreviation, section number, and year or edition. Match the style required by your court, professor, or publisher.
Is this the official text of Colorado law?
No. This page is for research and education and may not include the most recent amendments. For official current law, check the Colorado official source linked on this page or consult a licensed Colorado attorney.
How does Colorado § 12-280-131 apply to my situation?
Statutes are interpreted in context, and application depends on your specific facts. Only a licensed attorney in Colorado can advise on how this section applies to you. Contact your state or local bar association for a referral.
Sources & Verification
Not legal advice. Verify against the official source and consult a licensed attorney in Colorado.