{"data":{"id":"us-md/md.-code-health-general-21-2c-01","jurisdiction":"us-md","citation":"Md. Code, Health - General § 21–2C–01","heading":"","body":"(a) In this subtitle the following words have the meanings indicated.\n(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.\n(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).\n(d) “Board” means the Prescription Drug Affordability Board.\n(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).\n(2) “Brand name drug” does not include an authorized generic as defined by 42 C.F.R. § 447.502.\n(f) “Current shortage” means a drug:\n(1) Listed as current on the federal Food and Drug Administration’s Drug Shortage Database; or\n(2) Otherwise determined by the Board to be in short supply in the State.\n(g) “Generic drug” means:\n(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);\n(2) An authorized generic as defined by 42 C.F.R. § 447.502; or\n(3) A drug that entered the market before 1962 that was not originally marketed under a new drug application.\n(h) “Manufacturer” means an entity that:\n(1) (i) Engages in the manufacture of a prescription drug product; or\n(ii) Enters into a lease with another manufacturer to market and distribute a prescription drug product under the entity’s own name; and\n(2) Sets or changes the wholesale acquisition cost of the prescription drug product it manufactures or markets.\n(i) “Prescription drug product” means a brand name drug, a generic drug, a biologic, or a biosimilar.\n(j) “Stakeholder Council” means the Prescription Drug Affordability Stakeholder Council.","path":["Article - Health - General"],"source_url":"https://mgaleg.maryland.gov/mgawebsite/Laws/StatuteText?article=ghg\u0026section=21-2C-01","current_through":"2026-01-01","vintage":"","retrieved_at":"2026-09-14T19:58:48Z","sha256":"8cc859a990b6f54e0ae15df4ce30dda3ef59ec452fe3bf34198a45c589f06e26","source_id":"us-md","stale":false,"prev":"us-md/md.-code-health-general-21-2b-06","next":"us-md/md.-code-health-general-21-2c-02"},"notice":"GroundRules: Original legal text. Not legal advice."}