HOUSE BILL NO. 6477

A bill to provide for the establishment of an international wholesale prescription drug importation program; to provide for the powers and duties of certain state and local governmental officers and entities; and to require the promulgation of rules.

the people of the state of michigan enact:

Sec. 1. This act may be cited as the "international prescription drug importation act".

Sec. 3. As used in this act:

(a) "Department" means the department of health and human services.

(b) "Eligible exporter" means an exporter that meets the requirements described in section 7(2).

(c) "Eligible importer" means an importer that meets the requirements described in section 7(1).

(d) "Exporter" means an international export pharmacy, international manufacturer, or an international wholesale distributor.

(e) "Federal act" means the federal food, drug, and cosmetic act, 21 USC 301 to 399i.

(f) "Foreign recipient" means an entity other than the original prescription drug manufacturer that receives the prescription drug from the manufacturer before it is imported into this state under the program.

(g) "Importer" means a state wholesale distributor, state pharmacy, or state pharmacist.

(h) "International export pharmacy" means a pharmacy that is located outside of the United States and is licensed under part 177 of the public health code, 1978 PA 368, MCL 333.17701 to 333.17780.

(i) "International manufacturer" means a prescription drug manufacturer that is located outside of the United States and is licensed under part 177 of the public health code, 1978 PA 368, MCL 333.17701 to 333.17780.

(j) "International wholesale distributor" means a prescription drug wholesale distributor that is located outside of the United States and is licensed under part 177 of the public health code, 1978 PA 368, MCL 333.17701 to 333.17780.

(k) "Prescription drug" means that term as defined in section 17708 of the public health code, 1978 PA 368, MCL 333.17708, except that it only includes prescription drugs that are intended for use in human beings.

(l) "Program" means the international wholesale prescription drug importation program developed by the department under this act.

(m) "State pharmacist" means a pharmacist as that term is defined in section 17707 of the public health code, 1978 PA 368, MCL 333.17707.

(n) "State pharmacy" means a pharmacy as that term is defined in section 17707 of the public health code, 1978 PA 368, MCL 333.17707.

(o) "State wholesale distributor" means a wholesale distributor as that term is defined in section 17709 of the public health code, 1978 PA 368, MCL 333.17709.

(p) "Wholesale prescription drug importation list" means the wholesale prescription drug importation list developed under section 5.

Sec. 5. (1) Subject to subsection (4) and this act, by January 1, 2023, the department shall develop and implement an international wholesale prescription drug importation program for the purposes of importing safe and effective drugs from foreign nations with which the United States has a mutual recognition agreement, cooperation agreement, memorandum of understanding, or other federal mechanism that recognizes the foreign nation's adherence to good manufacturing practice regulations for pharmaceutical products under 21 CFR parts 210 and 211.

(2) In developing the program, the department shall create and maintain a wholesale prescription drug importation list that identifies each prescription drug that may be imported into this state under the program. The department shall review the wholesale prescription drug importation list every 6 months and revise the list if the department considers it necessary. The department shall not include a prescription drug on the wholesale prescription drug importation list unless all of the following are met:

(a) The prescription drug is one that has been identified by the department under subsection (3).

(b) The department determines that the prescription drug meets the standards for safety, effectiveness, misbranding, and adulteration of the United States Food and Drug Administration.

(c) Importing the prescription drug would not violate federal patent laws.

(d) The prescription drug is not any of the following:

(i) A controlled substance as that term is defined in section 7104 of the public health code, 1978 PA 368, MCL 333.7104.

(ii) A biological product as that term is defined in 42 USC 262.

(iii) An infused drug.

(iv) An intravenously injected drug.

(v) A drug that is inhaled during surgery.

(vi) A drug that is a parenteral drug, the importation of which is determined by the United States Secretary of the federal department of Health and Human Services to pose a threat to public health.

(3) The department shall create and maintain a list identifying each prescription drug that retails for less in a foreign nation and that, if imported under the program, would provide a cost savings to this state. The department shall review the list described in this subsection every January and revise the list if the department considers it necessary.

(4) The department shall not implement the program unless the program is approved by or otherwise authorized under federal law.

Sec. 7. (1) An importer may import a prescription drug identified on the wholesale prescription drug importation list if the importer registers with the department on a form and in a manner required by the department before importing the prescription drug into this state and the impo