(1) The Canadian prescription drug importation program is created in the state department. Upon receiving approval of the program as described in section 25.5-2.5-205 (1), the state department shall contract with one or more vendors to provide services under the program. For three years following August 2, 2019, the selection of any vendor pursuant to this subsection (1) is exempt from the requirements of the procurement code, articles 101 to 112 of title 24.
(2) (a) Each vendor, in consultation with the state department and any other vendors, shall establish a wholesale prescription drug importation list that identifies the prescription drugs that have the highest potential for cost savings to the state. In developing the list, each vendor shall consider, at a minimum, which prescription drugs will provide the greatest cost savings to the state, including prescription drugs for which there are shortages, specialty prescription drugs, and high-volume prescription drugs. Each vendor shall revise the list at least annually and at the direction of the state department pursuant to subsection (2)(b) of this section.
The state department shall review the wholesale prescription drug importation list atleast every three months to ensure that it continues to meet the requirements of the program. The state department may direct a vendor to revise the list, as necessary.
Each vendor, in consultation with the state department, shall identify Canadian suppliers that are in full compliance with relevant Canadian federal and provincial laws and regulations and that have agreed to export prescription drugs identified on the wholesale prescription drug importation list. Each vendor shall verify that such Canadian suppliers meet all of the requirements of the program and will export prescription drugs at prices that will provide cost savings to the state. Each vendor shall contract with such eligible Canadian suppliers, or facilitate contracts between eligible importers and Canadian suppliers, to import prescription drugs under the program.
Each vendor shall assist the state department in developing and administering a distribution program within the program.
Each vendor shall assist the state department with the annual report described insection 25.5-2.5-206 and provide any information requested by the state department for the report.
Each vendor shall ensure the safety and quality of drugs imported under the program,as follows:
(I) (A) For an initial imported shipment, ensure that each batch of the drug in the shipment is statistically sampled and tested for authenticity and degradation in a manner consistent with the federal act; and
(B) For any subsequent imported shipment, ensure that a statistically valid sample of the shipment is tested for authenticity and degradation in a manner consistent with the federal act; (II) Certify that each drug:
Is approved for marketing in the United States and is not adulterated or misbranded;and
Meets all of the labeling requirements under 21 U.S.C. sec. 352;
Maintain qualified laboratory records, including complete data derived from all tests necessary to ensure that the drug is in compliance with the requirements of this section; and
Maintain documentation demonstrating that the testing required by this section wasconducted at a qualified laboratory in accordance with the federal act and any other applicable federal and state laws and regulations governing laboratory qualifications.
All testing required by this section must be conducted in a qualified laboratory thatmeets the standards under the federal act and any other applicable federal and state laws and regulations governing laboratory qualifications for drug testing.
Each vendor shall maintain a list of all eligible importers that participate in the program.
Each vendor shall ensure compliance with Title II of the federal "Drug Quality andSecurity Act", Pub.L. 113-54, by all Canadian suppliers, eligible importers, distributors, and other participants in the program.
Each vendor shall provide an annual financial audit of its operations to the statedepartment. Each vendor shall also provide quarterly financial reports specific to the program and shall include information concerning the performance of its subcontractors and vendors. The state department shall determine the format and contents of the reports.
Each vendor shall submit evidence of a surety bond with any bid or initial contractnegotiation documents and shall maintain documentation of evidence of such a bond with the state department throughout the contract term. The surety bond may be from this state or any other state in the United States and must be in an amount of at least twenty-five thousand dollars. The surety bond or comparable security arrangement must include the state of Colorado as a beneficiary. In lieu of the surety bond, a vendor may provide a comparable security agreement, such as an irrevocable letter of credit or a deposit into a trust account or financial institution that includes the state of Colorado as a beneficiary, payable to the state of Colorado. The purposes of the bond or other security arrangement are to:
Ensure participation of the vendor in any civil or criminal legal action by the statedepartment, any other state agency, or private individuals or entities against the vendor because of the vendor's failure to perform under the contract, including but not limited to causes of actions for personal injury, negligence, and wrongful death;
Ensure payment by the vendor through the use of a bond or other comparable security arrangement of any legal judgments and claims that are awarded to the state, other entities acting on behalf of the state, individuals, or organizations if the vendor is assessed a final judgment or other monetary penalty in a court of law for a civil or criminal action under the program. The bond or comparable security arrangement may be accessed if the vendor fails to pay any judgment or claim within sixty days after final judgment.
Allow for civil and criminal litigation claims to be made against the bond or othercomparable security arrangements for up to one year after the vendor's contract under the program has ended with the state department, the vendor's license is no longer valid, or the program has ended, whichever occurs last.
Each vendor shall maintain information and documentation submitted under this section for a period of at least seven years.
The state department may require each vendor to collect any other information necessary to ensure the protection of the public health.
Source: L. 2019: Entire part added, (SB 19-005), ch. 184, p. 2066, § 3, effective August 2.