2023 Colorado Revised Statutes › Title 25.5 - HEALTH CARE POLICY AND FINANCING (§§ 25.5-1-101 — 25.5-11-101) › PRESCRIPTION DRUGS (§§ 25.5-2.5-101 — 25.5-2.5-208) › Article 2.5 - PRESCRIPTION DRUGS (§§ 25.5-2.5-101 — 25.5-2.5-208) › Part 2 - CANADIAN PRESCRIPTION DRUG IMPORTATION PROGRAM (§§ 25.5-2.5-201 — 25.5-2.5-208) › Section 25.5-2.5-208 - Expansion of program to include additional foreign suppliers - federal action required - notice to general assembly

(1)
Notwithstanding any provision of this part 2 to the contrary, the state department may expand the program to allow a manufacturer, wholesale distributor, or pharmacy from a nation other than Canada to export prescription drugs into the state under the program if:
(a)
The United States congress enacts legislation to amend
21 U.S.C. sec. 384
or otherwise enacts legislation to permit states, including Colorado, to import prescription drugs from foreign countries other than Canada;
(b)
A vendor, in consultation with the state department, has identified the manufacturer, wholesale distributor, or pharmacy as a supplier that satisfies the requirements of the program and that will export prescription drugs at prices that will provide cost savings to the state;
(c)
The manufacturer, wholesale distributor, or pharmacy is appropriately licensed or permitted under that nation's laws and regulations pertaining to the manufacturing, distribution, or dispensing of prescription drugs;
(d)
The manufacturer, wholesale distributor, or pharmacy is located in a nation that is approved to export prescription drugs into Colorado by the United States secretary of health and human services or by another authority that is designated for such purpose by federal law; and
(e)
The state department submits evidence to the president of the senate, the speaker of the house of representatives, and the health and human services committee of the senate and the health and insurance committee of the house of representatives, or any successor committees, which evidence compares the exporting nation's regulatory system for prescription drugs to the regulatory system for prescription drugs administered by the United States food and drug administration pursuant to the federal act and demonstrates that the exporting nation's regulatory system is as stringent as the system in the United States or otherwise ensures the safety, purity, and potency of the prescription drugs from the exporting nation. The evidence must compare the regulations for:
(I)
Securing the supply chain for prescription drugs;
(II)
Prescription drug manufacturing;
(III)
Prescription drug labeling; and
(IV)
Prescription drug tracking and tracing.
(2)
If, upon the satisfaction of the conditions described in subsection (1) of this section, the state department decides to expand the program to allow a manufacturer, wholesale distributor, or pharmacy from a nation other than Canada to export prescription drugs into the state under the program, the executive director shall notify the president of the senate, the speaker of the house of representatives, and the health and human services committee of the senate and the health and insurance committee of the house of representatives, or any successor committees, of the state department's intent to do so. The executive director shall provide the notice at least thirty days before the program is expanded, and the notice may include any recommendations of the state department for legislation to amend this part 2 to reflect the expansion of the program.
(3)
If the state department expands the program in accordance with this section, an eligible importer may import a prescription drug from a foreign supplier pursuant to this section if the drug that is to be imported is a prescription drug, as defined in
21 U.S.C. sec. 384(a)(3)
.
Added by 2021 Ch. 57,§2, eff. 9/7/2021.
L. 2021: Entire section added, (SB 21-123), ch. 233, p. 233, §2, effective September 7.
2021 Ch. 57, was passed without a safety clause. See Colo. Const. art. V, § 1(3).
For the legislative declaration in SB 21-123, see section 1 of chapter 57, Session Laws of Colorado 2021.