25.1047.01000 Sixty-ninth Legislative Assembly of North Dakota Introduced by Representatives Nelson, Mitskog, Murphy, Bahl, O'Brien Senators Axtman, Dever, Lee A BILL for an Act to create and enact a new subsection to section 43-15.3-08 of the North Dakota Century Code, relating to prohibited acts of drug manufacturers; and to provide a penalty. BE IT ENACTED BY THE LEGISLATIVE ASSEMBLY OF NORTH DAKOTA: SECTION 1. A new subsection to section 43-15.3-08 of the North Dakota Century Code is created and enacted as follows: a.For purposes of this subsection: (1)"Contract pharmacy" means a pharmacy that has a contract with a covered entity to receive and dispense drugs to the covered entity's patients on its behalf. (2)"Covered entity" means an entity participating or authorized to participate in a federal drug discount program under 42 U.S.C. 256b. (3)"Drug" means a drug purchased under reduced pricing under section 340B of the federal Public Health Service Act [42 U.S.C. 201 et seq.] by a covered entity. b.Except as otherwise provided under section 43-15.3-09, it is a class B misdemeanor for a manufacturer, an agent or affiliate of that manufacturer, virtual manufacturer, or third-party logistics provider of a manufacturer's drugs, to: (1)Directly or indirectly deny, restrict, prohibit, or otherwise interfere with the acquisition of a drug by a contract pharmacy on behalf of a covered entity unless receipt of the drug is prohibited by federal law. (2)Prohibit a contract pharmacy from dispensing a drug by denying access to the drug. Page No. 1 25.1047.01000 HOUSE BILL NO. 1473 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Sixty-ninth Legislative Assembly (3)Require a covered entity or contract pharmacy to submit any claims, encounter, or utilization data as a condition for acquiring or receiving a drug, unless the claims, encounter, or utilization data sharing is required by federal law. (4)Interfere with the ability of a covered entity or contract pharmacy to dispense a drug to an eligible patient of the covered entity. (5)Offer or otherwise make available a drug in the form of a rebate, unless in the form of a discount at the time of sale and authorized under federal law. c.This subsection does not apply to the limited distribution of a drug as required under 21 U.S.C. 355-1. Page No. 2 25.1047.01000 1 2 3 4 5 6 7 8 9 10