Signed by Governor Jared Polis

Vote Smart's Synopsis:

Vote to pass with amendment a bill that authorizes importing prescription drugs from Canada.

Highlights:

• Defines “Canadian supplier” as a manufacturer, wholesale distributor, or pharmacy that is appropriately licensed or permitted under Canadian Federal and Provincial laws and regulations to manufacture, distribute, or dispense prescription drugs (Sec. 3).

• Specifies that “Federal Act” refers to the federal “Food, Drug, and Cosmetic Act”, 21 U.S.C. Sec. 301 et seq (Sec. 3).

• Establishes the Canadian prescription drug importation program in the state department (Sec. 3).

• Authorizes the state department to contract with one or more vendors for the provision of services through this program, but only after federal approval of this program is officially given to the department (Sec. 3).

• Requires each vendor to establish a wholesale prescription drug importation list with prescription drugs that will be the most cost effective for the state, and to identify Canadian suppliers found to be compliant with relevant Canadian federal and provincial laws and regulations who have agreed to export the prescription drugs on the list (Sec. 3).

• Requires each vendor to work with the state department in developing and administering a distribution program within the program (Sec. 3).

• Authorizes the importation of prescription drugs through Canadian suppliers if (Sec. 3):

• The drug meets the standards of the Federal Food and Drug Administration concerning safety, efficacy, misbranding, and adulteration;

• The importation of the drug does not violate federal patent laws;

• The importation of the drug will cut costs; and 

• The drug is not:

• A controlled substance;

• A biological product;

• An infused drug;

• An intravenously injected drug;

• A drug inhaled during surgery; or

• A parental drug.

• Classifies an eligible importer as (Sec. 3):

• A pharmacist or wholesaler employed by or under contract with a medicaid pharmacy, for dispensing to the pharmacy’s medicaid recipients;

• A pharmacist or wholesaler employed by or under contract with the Department of Corrections, for dispensing to inmates;

• Commercial plans; and

• A licensed Colorado pharmacist or wholesaler with approval from the state department.

• Authorizes the state department to designate an office or division that must be a licensed pharmaceutical wholesaler or that contracts with a licensed pharmaceutical wholesaler , and will (Sec. 3):

• Set a maximum profit margin so that the licensed provider will not earn more than they would have made on the equivalent nonimported drug;

• Exclude generic products if importing them violates United States patent laws applicable to United States-branded products;

• Comply with specified requirements enacted in Title II of the Federal “Drug Quality and Security Act”; and

• Establish a responsible process or method for covering the administrative costs of the program.

• Requires the state department to submit a request to the United States Secretary of Health and Human Services for the approval of the program, on or before September 1, 2020 (Sec. 3).

• Appropriates $1,041,802 to the Department of Health Care Policy and Financing for the 2019-2020 Fiscal Year from the general fund in order to implement this act (Sec. 5).

Full Bill Text

Vote Smart's Synopsis:

Vote to pass with amendment a bill that authorizes importing prescription drugs from Canada.

Highlights:

• Defines “Canadian supplier” as a manufacturer, wholesale distributor, or pharmacy that is appropriately licensed or permitted under Canadian Federal and Provincial laws and regulations to manufacture, distribute, or dispense prescription drugs (Sec. 3).

• Specifies that “Federal Act” refers to the federal “Food, Drug, and Cosmetic Act”, 21 U.S.C. Sec. 301 et seq (Sec. 3).

• Establishes the Canadian prescription drug importation program in the state department (Sec. 3).

• Authorizes the state department to contract with one or more vendors for the provision of services through this program, but only after federal approval of this program is officially given to the department (Sec. 3).

• Requires each vendor to establish a wholesale prescription drug importation list with prescription drugs that will be the most cost effective for the state, and to identify Canadian suppliers found to be compliant with relevant Canadian federal and provincial laws and regulations who have agreed to export the prescription drugs on the list (Sec. 3).

• Requires each vendor to work with the state department in developing and administering a distribution program within the program (Sec. 3).

• Authorizes the importation of prescription drugs through Canadian suppliers if (Sec. 3):

• The drug meets the standards of the Federal Food and Drug Administration concerning safety, efficacy, misbranding, and adulteration;

• The importation of the drug does not violate federal patent laws;

• The importation of the drug will cut costs; and 

• The drug is not:

• A controlled substance;

• A biological product;

• An infused drug;

• An intravenously injected drug;

• A drug inhaled during surgery; or

• A parental drug.

• Classifies an eligible importer as (Sec. 3):

• A pharmacist or wholesaler employed by or under contract with a medicaid pharmacy, for dispensing to the pharmacy’s medicaid recipients;

• A pharmacist or wholesaler employed by or under contract with the Department of Corrections, for dispensing to inmates;

• Commercial plans; and

• A licensed Colorado pharmacist or wholesaler with approval from the state department.

• Authorizes the state department to designate an office or division that must be a licensed pharmaceutical wholesaler or that contracts with a licensed pharmaceutical wholesaler , and will (Sec. 3):

• Set a maximum profit margin so that the licensed provider will not earn more than they would have made on the equivalent nonimported drug;

• Exclude generic products if importing them violates United States patent laws applicable to United States-branded products;

• Comply with specified requirements enacted in Title II of the Federal “Drug Quality and Security Act”; and

• Establish a responsible process or method for covering the administrative costs of the program.

• Requires the state department to submit a request to the United States Secretary of Health and Human Services for the approval of the program, on or before September 1, 2020 (Sec. 3).

• Appropriates $1,041,802 to the Department of Health Care Policy and Financing for the 2019-2020 Fiscal Year from the general fund in order to implement this act (Sec. 5).

Full Bill Text