Section 590-570-1 - DefinitionsUnless the context indicates otherwise, the following words and phrases shall have the following meanings:
A.Acquisition date. "Acquisition date" means the date that the manufacturer registered with the FDA as the labeler for the drug product.B.Brand-name drug. "Brand-name drug" means a prescription drug, having a unique NDC, marketed under a proprietary name or registered trademark name, including a biological product, and approved under a New Drug Application or Biologics License Application.C.Dosage Form. "Dosage Form" means the physical form in which a prescription drug is produced and dispensed, such as a tablet, a capsule, or an injectable. D.Drug product family. "Drug product family" means a group of one or more prescription drugs that share a unique non-proprietary name and dosage form.E.Generic drug. "Generic drug" means a prescription drug, having a unique NDC, whether identified by its chemical, proprietary or nonproprietary name, that is not a brand-name drug, is therapeutically equivalent to a brand-name drug in dosage, strength, method of consumption, performance and intended use, and approved under an Abbreviated New Drug Application. "Generic drug" includes a biosimilar product.F.Introduced to Market. "Introduced to Market" means made available for purchase in the United States.G.Manufacturer. "Manufacturer" means an entity that manufactures or repackages, and sets the wholesale acquisition cost for, prescription drugs that are distributed in the State.H.MHDO. "MHDO" means the Maine Health Data Organization.I.M.R.S. "M.R.S." means Maine Revised Statutes.J.National Drug Code (NDC). "National Drug Code (NDC)" means the three-segment code maintained by the federal Food and Drug Administration that includes a labeler code, a product code, and a package code for a drug product and that has been converted to an 11-digit format consisting of five digits in the first segment, four digits in the second segment, and two digits in the third segment. A three-segment code shall be considered converted to an 11-digit format when, as necessary, at least one "0" has been added to the front of each segment containing less than the specified number of digits such that each segment contains the specified number of digits.K.New Prescription Drug. "New prescription drug" means a drug receiving initial approval under an original new drug application under 21 United States Code, Section 355(b), under an abbreviated new drug application under 21 United States Code, Section 355(j), or under a biologics license application under 42 United States Code, Section 262. Each product listed on the application shall be considered a new prescription drug.L.Nonproprietary name. "Nonproprietary name" means the generic name assigned by the United States Adopted Names (USAN) Council.M.Pharmacy Benefits Manager (PBM). "Pharmacy Benefits Manager (PBM)" means an entity that performs pharmacy benefits management, as defined in 24-A M.R.S. §4347, sub-section 17.N.Prescription drug. "Prescription drug" means a drug, as defined in 21 United States Code, Section 321(g) or a biological product as defined in 42 United States Code, Section 262(i)(1) that: i. Is intended for human use;ii. Is not a device within the meaning of 21 United States Code, Section 321(h); andiii. By federal or state law, can be lawfully dispensed or administered only on prescription by a licensed health care professional.O.Pricing component data. "Pricing component data" means data unique to each reporting entity subject to this rule that evidences the cost to each reporting entity to make a prescription drug product available to consumers and the payments received by each reporting entity to make a prescription drug product available to consumers, taking into account any price concessions, and that is measured uniformly among and between the entities, as detailed by this rule adopted by the organization pursuant to 22 M.R.S. §8737.P.Pricing unit. "Pricing unit" means the smallest dispensable amount of a prescription drug product that could be dispensed.Q.Proprietary name. "Proprietary name" means the brand or trademark name of the drug reported to the FDA.R.Rebate. "Rebate" means a discount, chargeback, or other price concession that affects the price of a prescription drug product, regardless of whether conferred through regular aggregate payments, on a claim-by-claim basis at the point-of-sale, as part of retrospective financial reconciliations (including reconciliations that also reflect other contractual arrangements), or by any other method. "Rebate" does not mean a "bona fide service fee", as such term is defined in 42 Code of Federal Regulations, Section 447.502, published October 1, 2019.S.Reporting entity. "Reporting entity" means any manufacturer, pharmacy benefits manager, wholesale drug distributor, or any other entity required to register and/or submit data pursuant to 22 M.R.S. §§8732, 8734, 8735 and this rule.T.Specialty Drug Under Medicare Part D Program. "Specialty Drug Under Medicare Part D Program" means a prescription drug product having a wholesale acquisition cost that exceeds the threshold set for a specialty drug by the Centers for Medicare and Medicaid Services under the Medicare Part D.U.Tax identification number (TIN). "Tax identification number (TIN)" means the 9-digit Taxpayer Identification Number used by the Internal Revenue Service (IRS).V.Wholesale acquisition cost (WAC). "Wholesale acquisition cost (WAC)" means a manufacturer's published list price for sale of a prescription drug product with a unique NDC to any wholesale drug distributor or other entity that purchases a prescription drug directly from the manufacturer, not including any price concessions.W.Wholesale drug distributor. "Wholesale drug distributor" means an entity that i. is licensed by the State to engage in the sale of prescription drugs to persons and/or entities other than a consumer or patient; andii. distributes prescription drugs, of which it is not the manufacturer, to persons and /or entities other than a consumer or patient in the State.90-590 C.M.R. ch. 570, § 1