Implementation of a Canadian Prescription Drug Importation Program

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In accordance with Senate Bill 19-005, passed in 2019, the Department of Health Care Policy & Financing (Department) has been developing a Canadian prescription drug importation program. The Federal Food Drug and Cosmetic Act (FDCA) Section 804 permits importation and reimportation 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. HCPF has released a program solicitation seeking vendors as part of the next steps in program development.

Program Details

  • Program Overview - The state of Colorado has program oversight. We are seeking a vendor to perform administrative (oversight) functions. That vendor will perform oversight functions to the Foreign Seller (Canadian Wholesaler) and Colorado Importer (U.S. Wholesaler or Pharmacist), who is responsible for testing, relabeling, and drug distribution to participating pharmacies. Pharmacies dispense the imported prescription drugs to Colorado consumers.
  • Colorado's Canadian Drug Importation Program Frequently Asked Questions
  • Program Timeline - The Colorado bill was signed into law in May 2019. The Safe Importation plan was released 2 months later.  In December of 2019, the department of health and human services, or HHS, released a notice of proposed rulemaking, or the draft rule, to which Colorado responded with a program proposal and extensive comments on the proposed rule in March of 2020, in hopes of seeing Colorado’s requested changes updated in a final version of the rule.  The draft and subsequent final rule gave Colorado the guardrails for what a program needed to have for the FDA to approve an importation program. The final rule went into effect on November 30, 2020. Colorado took some time to digest the final rule and released an Invitation to Negotiate, or ITN, in January 2021, seeking vendors for our program. The ITN closed at the end of April and we are currently reviewing the multiple bids we have received.  Over the next few months, we will evaluate the bids, negotiate with chosen vendors, and sign contracts to further develop our program.  Taking the procurement process and all requirements of the final rule into consideration, we estimate that we may have an approved program by early summer of 2022 and begin importing within a few months of that approval.   
  • Executive order on Promoting Competition in the American Economy - July 9, 2021

Release of Program Solicitation (Invitation to Negotiate)

Release of Draft Importation Program Application

Stakeholder Engagement Opportunities

Please check back regularly for upcoming stakeholder events.

Past Stakeholder Sessions

October 15, 2020

Resources

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.