45:14-82.2 Definitions.
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/nj/title-45/chapter-14/45-14-82-2·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
1. As used in P.L.2023, c.106 (C.45:14-82.2 et seq.):
"Biosimilar" means a drug that is produced or distributed pursuant to a biologics license application approved under 42 U.S.C. s.262(k)(3).
"Brand-name drug" means a prescription drug approved under 21 USC s.355(b) or 42 USC s.262.
"Carrier" means the same as that term is defined in section 2 of P.L.1997, c.192 (C.26:2S-2).
"Division" means the Division of Consumer Affairs in the Department of Law and Public Safety.
"Drug group" means a group of drugs defined by the division for the purpose of facilitating revenue and cost reporting by manufacturers, carriers, pharmacy benefits managers, and wholesalers under sections 2 through 6 of P.L.2023, c.106 (C.45:14-82.3 through 45:14-82.7).
"Logistics provider" means an entity that receives a prescription drug product from the original or contract manufacturer, warehouses and delivers the prescription drug product at the direction of the manufacturer, and does not purchase, sell, trade, or take title to the prescription drug product.
"Manufacturer" means a business registering under P.L.1961, c.52 (C.24:6B-1 et seq.) as a drug manufacturing business as defined in section 13 of P.L.1961, c.52 (C.24:6B-12).
"Market introduction" means the month and year in which a manufacturer acquired or first marketed a drug for sale in New Jersey.
"Medicare Part D specialty threshold" means the specialty tier cost threshold established by the Centers for Medicare and Medicaid Services.
"New drug" means a prescription drug that has received initial approval under an original new drug application under 21 U.S.C. s.355(b), under an abbreviated new drug application under 21 U.S.C. s.355(j), or under a biologics license application under 42 U.S.C. s.262. In cases where multiple products are included on an application, each product shall be considered a new prescription drug.
"Pharmacy benefits manager" means a corporation, business, or other entity, or unit within a corporation, business, or other entity that, pursuant to a contract or under an employment relationship with a carrier, a self-insurance plan or other third-party payer, either directly or through an intermediary, administers prescription drug benefits on behalf of a carrier, self-funded plan, or other third-party payer.
"Pharmacy services administrative organization" means an entity operating within the State that contracts with independent pharmacies to conduct business on their behalf with third-party payers.
"Pricing unit" means the smallest dispensable amount of a prescription drug that could be dispensed.
"Reporting entity" means any manufacturer, carrier, pharmacy benefits manager, wholesaler, pharmacy services administrative organization, or any other entity required to report to the division under P.L.2023, c.106 (C.45:14-82.2 et seq.).
"Wholesale acquisition cost (WAC)" means, with respect to a prescription drug, the manufacturer's list price for the drug to wholesalers or direct purchasers in New Jersey, as defined in 42 U.S.C. s.1395w-3a(c)(6)(B), excluding any discounts, rebates, or reductions in price, for the most recent month for which the information is available, as reported in wholesale price guides or other publications of prescription drug pricing.
"Wholesaler" means a business registering under P.L.1961, c.52 (C.24:6B-1 et seq.) as a wholesale drug business as defined in section 13 of P.L.1961, c.52 (C.24:6B-12). "Wholesaler" shall not include a common carrier, or an employee thereof, whose possession of a prescription drug product is in the usual course of the common carrier's or employee's business or employment, and shall not include a logistics provider or an employee thereof.
L.2023, c.106, s.1.