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§ 21-2C-01. Definitions

West's Annotated Code of MarylandHealth--GeneralEffective: July 1, 2019

West's Annotated Code of Maryland
Health--General
Title 21. Food, Drugs, and Cosmetics (Refs & Annos)
Subtitle 2c. Prescription Drug Affordability Board (Refs & Annos)
Effective: July 1, 2019
MD Code, Health - General, § 21-2C-01
§ 21-2C-01. Definitions
Currentness
In general
(a) In this subtitle the following words have the meanings indicated.
Biologic
(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.
Biosimilar
(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).
Board
(d) “Board” means the Prescription Drug Affordability Board.
Brand name drug
(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.
Generic drug
(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.
Manufacturer
(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.
Prescription drug product
(h) “Prescription drug product” means a brand name drug, a generic drug, a biologic, or a biosimilar.
Stakeholder Council
(i) “Stakeholder Council” means the Prescription Drug Affordability Stakeholder Council.

Credits

Added by Acts 2019, c. 692, § 1, eff. July 1, 2019.
MD Code, Health - General, § 21-2C-01, MD HEALTH GEN § 21-2C-01
Current through legislation effective through April 9, 2023, from the 2024 Regular Session of the General Assembly. Some statute sections may be more current, see credits for details.
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