§ 21-2C-01
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/md/health-general/21-2c-01·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
§21–2C–01.
(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.
(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)“Current shortage” means a drug:
(1)Listed as current on the federal Food and Drug Administration’s Drug Shortage Database; or
(2)Otherwise determined by the Board to be in short supply in the State.
(g)“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.
(h)“Manufacturer” means an entity that:
(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.
(i)“Prescription drug product” means a brand name drug, a generic drug, a biologic, or a biosimilar.
(j)“Stakeholder Council” means the Prescription Drug Affordability Stakeholder Council.