CHAPTER 126-CC WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM
Section 126-CC:2
126-CC:2 Design of Program: Rulemaking. –
I. There is hereby established the wholesale prescription drug importation program, referred to in this chapter as the "program," to provide for the wholesale importation of prescription drugs from Canada by or on behalf of the state.
II. The department, in consultation with appropriate federal and other state agencies and interested parties, shall design the program to comply with the applicable requirements of 21 U.S.C. section 384, including requirements regarding safety and cost savings. The program design shall:
(a) Designate a state agency to become a licensed drug wholesaler or to contract with a licensed drug wholesaler in order to seek federal certification and approval, pursuant to RSA 126-CC:3, to import safe prescription drugs and provide cost savings to consumers in the state.
(b) Use prescription drug suppliers in Canada regulated under the laws of Canada or of one or more Canadian provinces, or both.
(c) Ensure that only prescription drugs that can meet the federal Food and Drug Administration's safety, effectiveness and other standards are imported by or on behalf of the state.
(d) Import only those prescription drugs expected to generate substantial cost savings for consumers in the state.
(e) Ensure that the program complies with the transaction and tracing requirements of 21 U.S.C. sections 360eee and 360eee-1 to the extent feasible and practical prior to imported prescription drugs coming into the possession of the licensed United States drug wholesaler and that the program complies fully with those federal requirements after imported prescription drugs are in the possession of the licensed drug wholesaler.
(f) Prohibit the distribution, dispensing, or sale of imported prescription drugs outside of the state.
(g) Recommend a method to finance the program which will not jeopardize consumer cost savings.
(h) Include an audit function.
III. The commissioner shall adopt rules pursuant to RSA 541-A, to design the program in accordance with this chapter.
IV. The department shall submit a request for approval and certification of the program to the United States Department of Health and Human Services on or before February 1, 2021.