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Statutes Text

Article - Health - General




§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.

    (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)    “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.

    (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.

    (h)    “Prescription drug product” means a brand name drug, a generic drug, a biologic, or a biosimilar.

    (i)    “Stakeholder Council” means the Prescription Drug Affordability Stakeholder Council.



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