N.J. Admin. Code § 13:45K-1.2
The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.
"Biological product" or "biologics" has the meaning of biological product as defined at 42 U.S.C. § 262(i)(1).
"Biosimilar" means a drug that is produced or distributed pursuant to a biologics license application approved pursuant to 42 U.S.C. § 262(k)(3).
"Brand-name drug" means a prescription drug approved pursuant to:
"Carrier" means the same as that term is defined in section 2 at P.L. 1997, c. 192 (N.J.S.A. 26:2S-2).
"Data Collection Manual" means the Drug Price Transparency Data Collection Manual that was issued in October 2024, and is incorporated herein by reference, as amended and supplemented, and available on the Division website at https://www.njconsumeraffairs.gov/.
"Division" means the Division of Consumer Affairs in the Department of Law and Public Safety.
"Drug group" means a group of one or more prescription drugs that share a unique generic drug description or nontrade name.
"Generic drug" means a prescription drug that is marketed or distributed:
"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 pursuant to P.L. 1961, c. 52 (N.J.S.A. 24:6B-1 et seq.), as a drug manufacturing business as defined in section 13 at P.L. 1961, c. 52 (N.J.S.A. 24:6B-12), or a business which creates, makes, or produces prescription drugs that are biological products. A business that:
"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 through an original or supplemental new drug application pursuant to 21 U.S.C. § 355(b), under an abbreviated new drug application pursuant to 21 U.S.C. § 355(j), or under a biologics license application pursuant to 42 U.S.C. § 262. In cases where multiple products are included on an application, each product shall be considered a new prescription drug.
"Pharmacy benefits manager" or "PBM" means a corporation, business, or other entity, or unit within a corporation, business, or other entity that, pursuant to a contract or pursuant to 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 for New Jersey residents on behalf of a carrier, self-funded plan, or other third-party payer.
"Pharmacy services administrative organization" or "PSAO" means an entity operating within the State that contracts with independent pharmacies to conduct business on their behalf with third-party payers.
"Prescription drug" means a drug, as defined at 21 U.S.C. § 321(g), or a biological product as defined at 42 U.S.C. § 262(i)(1), which, pursuant to Federal law, is required to be labeled prior to being delivered to the pharmacist, with "Rx Only" or is required by any applicable Federal or State law, rule, or regulation to be dispensed pursuant to a prescription drug order or is restricted to use by a practitioner only.
"Pricing unit" means the smallest amount of a prescription drug that could be dispensed or administered.
"Reporting entity" means any manufacturer, carrier, pharmacy benefits manager, wholesaler, pharmacy services administrative organization, or any other entity required to report to the Division pursuant to P.L. 2023, c. 106 (N.J.S.A. 45:14-82.2 et seq.).
"Wholesale acquisition cost" or "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 at 42 U.S.C. § 1395w-3a(c)(6)(B), excluding any discounts, rebates, or reductions in price as reported in wholesale price guides or other publications of prescription drug pricing.
"Wholesaler" means a business required to be licensed pursuant to N.J.S.A. 24:6B-15. "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.
N.J. Admin. Code § 13:45K-1.2