§ 21–2C-01
Statutes in effect as of October 1, 2026.
Md. Code Ann., Health-Gen. § 21-2C-01 (2026)
Title 21. Food, Drugs, and Cosmetics
Subtitle 2C. Prescription Drug Affordability Board
§ 21–2C-01LinkCopy Citation
(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)
“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:
(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.
(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.