Implementation of a Canadian Prescription Drug Importation Program

In accordance with Senate Bill 19-005, passed in 2019, the Department of Health Care Policy & Financing (HCPF) is developing a Canadian prescription drug importation program. The Federal Food Drug and Cosmetic Act (FDCA) Section 804 permits importation of prescription drugs from Canada by a pharmacist or wholesaler, provided the drugs meet certain minimum standards, will pose no additional risk to the public's health and safety, and results in a significant reduction in costs to consumers. HHS can approve a program if these conditions are met.

Program Overview

Senate Bill 19-005, which directs the Department of Health Care Policy & Financing (HCPF) to implement a Canadian Prescription Drug Importation Program, was signed into law by Governor Jared Polis. In December of 2019, the federal Department of Health and Human Services (HHS) released a Notice of Proposed Rulemaking, or the draft rule. In response, Colorado responded with a program proposal and extensive comments in March of 2020, in hopes of seeing Colorado’s requested changes updated in a final version of the rule. The final rule went into effect on November 30, 2020, putting in place the federal regulatory framework to successfully develop and operate an Importation Program. After taking the provisions of the Final Rule into account, HCPF released an Invitation to Negotiate (ITN) in January 2021, seeking vendors for the program. Upon closure of the ITN in April 2021, HCPF embarked on negotiations with supply chain partners and the identification of program consultants and certifiers to ensure compliant program development. HCPF announced all program partners in August 2022. On December 5th, 2022, HCPF announced the submission of a Section 804 Importation Program (SIP) application to the federal Food and Drug Administration (FDA) for review and approval. HCPF submitted its most recent amendment to its SIP application to FDA on August 28, 2024. HCPF estimates that the Colorado Importation Program will be approved in 2024.

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FDA approved manufacturers will sell the eligible prescription drugs to Colorado’s Foreign Seller, AdiraMedica, which is located in Canada. AdiraMedica will export the eligible prescription drug to Colorado’s Importer, Premier Pharmaceuticals LLC. (Premier), located in the United States. Premier will have the imported medications sent to Q Laboratories for testing. Once the tests are approved by FDA, the imported drugs will be relabeled by Premier and then can be distributed to Colorado pharmacies where they can be dispensed to Colorado consumers.

HCPF has identified the necessary supply chain partners including a Foreign Seller (AdiraMedica,LLC), Importer (Premier Pharmaceuticals, LLC, and compliance & reporting vendor (Rocky Mountain Poison & Drug Safety). The Foreign Seller (a Canadian wholesaler) will be responsible for procuring Canadian drugs for exportation to the United States. The Importer (a U.S. Wholesaler) will be responsible for testing, relabeling, and drug distribution to participating Colorado pharmacies. The Program’s reporting vendor will manage the adverse event reporting process for the program, as well as consumer education and communication.

• Colorado's Canadian Drug Importation Program Frequently Asked Questions
• Importation Vendor Fact Sheet
• Manufacturer Fact Sheet

Annual Report to the Colorado General Assembly

• 2023 Annual Report

Colorado Section 804 Importation Program (SIP) Application

2024 Application Documents

• Amended SIP Application
• Amended SIP Appendices
  • Appendix Contents
  • Appendix A - SIP Sponsor
  • Appendix B - Foreign Seller
  • Appendix C - Importer
  • Appendix D - Drug List Data
  • Appendix E - Actuarial Cost Analysis
  • Appendix F - Certification Reports
  • Appendix G - Figure Library
  • Appendix H - FDA Correspondence
  • Appendix I - Stakeholder Engagement

2022 Application Documents

• SIP Application
• SIP Appendices

Resources

• Colorado Citizen Petition Response to PhRMA (Docket No.2023–P-1773-004) - July 2024
• Amended SIP Application Press Release - February 2024
• FDA Request For Information to SIP Application - March 2023
• SIP Application Press Release - December 2022
• Importation Vendor Press Release - August 2022
• Importation Vendor Fact Sheet
• Manufacturer Fact Sheet
• Executive order on Promoting Competition in the American Economy - July 2021
• Drug Importation in Colorado International Pricing Report - January 2021
• SB 19-005 Canadian Prescription Drug Importation Act
• Federal Statute Regarding Canadian Drug Importation (21 U.S.C. 384)
• FDA Takes Action to Help Lower U.S. Prescription Drug Prices
• Final Rule: Importation of Prescription Drugs
• Colorado's Canadian Drug Importation Program Frequently Asked Questions
• Importation Program Solicitation Press Release - January 2021

Stakeholder Opportunities

• The Department held a virtual stakeholder meeting on March 12, 2024.
  • Stakeholder Meeting Presentation
  • Webinar Recording
• The Department held a virtual stakeholder meeting on January 10, 2023.
  • Stakeholder Meeting Presentation
  • Webinar Recording

Stay Informed

We encourage you to sign up for updates on our drug importation work. Please fill out the signup form to be added to our list.

We can also be contacted via email at HCPF_005DrugImportation@state.co.us.