Eligible prescription drugs - eligible Canadian suppliers - eligible importers - distribution requirements.

  1. Law
  2. Colorado Revised Statutes
  3. Health Care Policy And Financing
  4. Prescription Drugs
  5. Eligible prescription drugs - eligible Canadian suppliers - eligible importers - distribution requirements.

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(1) An eligible importer may import a prescription drug from a Canadian supplier if:

  1. The drug that is to be imported meets the federal food and drug administration'sstandards related to safety, effectiveness, misbranding, and adulteration;

  2. Importing the drug would not violate federal patent laws;

  3. Importing the drug is expected to generate cost savings; and

  4. The drug is not:

  1. A controlled substance as defined in 21 U.S.C. sec. 802 (6);

  2. A biological product as defined in 42 U.S.C. sec. 262 (i);

  3. An infused drug;

  4. An intravenously injected drug;

  5. A drug that is inhaled during surgery; or

  6. A drug that is a parenteral drug, the importation of which is determined by thefederal secretary of health and human services to pose a threat to public health.

(2) A Canadian supplier may export prescription drugs into the state under the program if the supplier:

  1. Is in full compliance with relevant Canadian federal and provincial laws and regulations;

  2. Is identified by the vendor as eligible to participate in the program pursuant to section 25.5-2.5-203 (2)(c); and

  3. Submits an attestation that the supplier has a registered agent in the United States,which attestation includes the name and United States address of the registered agent.

(3) The following entities are eligible importers and may obtain imported prescription drugs:

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

  2. A pharmacist or wholesaler employed by or under contract with the department ofcorrections, for dispensing to inmates in the custody of the department of corrections;

  3. Commercial plans, as defined by rules promulgated by the state board and as approved by the federal government; and

  4. A licensed Colorado pharmacist or wholesaler approved by the state department.

(4) (a) The state department shall designate an office or division that must be a licensed pharmaceutical wholesaler or that shall contract with a licensed pharmaceutical wholesaler licensed pursuant to part 3 of article 280 of title 12.

(b) The office or division designated by the state department pursuant to subsection (4)(a) of this section shall:

  1. Set a maximum profit margin so that a wholesaler, distributor, pharmacy, or otherlicensed provider participating in the program maintains a profit margin that is no greater than the profit margin that the wholesaler, distributor, pharmacy, or other licensed provider would have earned on the equivalent nonimported drug;

  2. Exclude generic products if the importation of the products would violate UnitedStates patent laws applicable to United States-branded products;

  3. Comply with the requirements of 21 U.S.C. sec. 360eee to 360eee-4 as enacted inTitle II of the federal "Drug Quality and Security Act"; and

  4. Determine a method for covering the administrative costs of the program, whichmethod may include a fee imposed on each prescription pharmaceutical product sold through the program or any other appropriate method as determined by the state department, but the state department shall not require a fee in an amount the state department determines would significantly reduce consumer savings.

(5) Canadian suppliers and eligible importers participating under the program:

  1. Shall comply with the tracking and tracing requirements of 21 U.S.C. sec. 360eee etseq.; and

  2. Shall not distribute, dispense, or sell prescription drugs imported under the programoutside of the state.

(6) A participating eligible importer shall submit to the vendor all of following information about each drug to be acquired by the importer under the program:

  1. The name and quantity of the active ingredient of the drug;

  2. A description of the dosage form of the drug;

  3. The date on which the drug is received;

  4. The quantity of the drug that is received;

  5. The point of origin and destination of the drug; and(f) The price paid by the importer for the drug.

(7) A participating Canadian supplier shall submit to the vendor the following information about each drug to be supplied by the Canadian supplier under the program: (a) The original source of the drug, including:

  1. The name of the manufacturer of the drug;

  2. The date on which the drug was manufactured; and

  3. The country, state or province, and city where the drug was manufactured;

  1. The date on which the drug is shipped;

  2. The quantity of the drug that is shipped;

  3. The quantity of each lot of the drug originally received and the source of the lot; and

  4. The lot or control number and the batch number assigned to the drug by the manufacturer.

(8) The state department shall immediately suspend the importation of a specific drug or the importation of drugs by a specific eligible importer if it discovers that any drug or activity is in violation of this section or any federal or state law or regulation. The state department may revoke the suspension if, after conducting an investigation, it determines that the public is adequately protected from counterfeit or unsafe drugs being imported into this state.

Source: L. 2019: Entire part added, (SB 19-005), ch. 184, p. 2068, § 3, effective August 2.


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