Section 21-2C-01 - Definitions(a) In this subtitle the following words have the meanings indicated.(b) "Biologic" means a drug that is produced or distributed in accordance with a biologics license application approved under 42 C.F.R. § 447.502.(c) "Biosimilar" means a drug that is produced or distributed in accordance with a biologics license application approved under 42 U.S.C. § 262(k)(3).(d) "Board" means the Prescription Drug Affordability Board.(e)(1) "Brand name drug" means a drug that is produced or distributed in accordance with an original new drug application approved under 21 U.S.C. § 355(c).(2) "Brand name drug" does not include an authorized generic as defined by 42 C.F.R. § 447.502.(f) "Generic drug" means: (1) A retail drug that is marketed or distributed in accordance with an abbreviated new drug application, approved under 21 U.S.C. § 355(j);(2) An authorized generic as defined by 42 C.F.R. § 447.502; or(3) A drug that entered the market before 1962 that was not originally marketed under a new drug application.(g) "Manufacturer" means an entity that:(1)(i) Engages in the manufacture of a prescription drug product; or(ii) Enters into a lease with another manufacturer to market and distribute a prescription drug product under the entity's own name; and(2) Sets or changes the wholesale acquisition cost of the prescription drug product it manufactures or markets.(h) "Prescription drug product" means a brand name drug, a generic drug, a biologic, or a biosimilar.(i) "Stakeholder Council" means the Prescription Drug Affordability Stakeholder Council.Added by 2019 Md. Laws, Ch. 692,Sec. 1, eff. 7/1/2019.