1. (a) In this subtitle the following words have the meanings indicated.
2. (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.
3. (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).
4. (d) “Board” means the Prescription Drug Affordability Board.

5. (e)

   1. (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. (2) “Brand name drug” does not include an authorized generic as defined by 42 C.F.R. § 447.502.

6. (f) “Current shortage” means a drug:

   1. (1) Listed as current on the federal Food and Drug Administration's Drug Shortage Database; or
   2. (2) Otherwise determined by the Board to be in short supply in the State.

7. (g) “Generic drug” means:

   1. (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. (2) An authorized generic as defined by 42 C.F.R. § 447.502; or
   3. (3) A drug that entered the market before 1962 that was not originally marketed under a new drug application.

8. (h) “Manufacturer” means an entity that:

   1. (1)

      1. (i) Engages in the manufacture of a prescription drug product; or
      2. (ii) Enters into a lease with another manufacturer to market and distribute a prescription drug product under the entity's own name; and
   2. (2) Sets or changes the wholesale acquisition cost of the prescription drug product it manufactures or markets.
9. (i) “Prescription drug product” means a brand name drug, a generic drug, a biologic, or a biosimilar.
10. (j) “Stakeholder Council” means the Prescription Drug Affordability Stakeholder Council.

Added by Acts 2019, c. 692, § 1, eff. July 1, 2019. Amended by Acts 2025, c. 610, § 1, eff. Oct. 1, 2025; Acts 2025, c. 611, § 1, eff. Oct. 1, 2025.