Maryland § 2-801

§ 2-801.

    (a)    In this subtitle the following words have the meanings indicated.

    (b)    (1)    “Essential off–patent or generic drug” means any prescription drug:

            (i)    For which all exclusive marketing rights, if any, granted under the Federal Food, Drug, and Cosmetic Act, § 351 of the federal Public Health Service Act, and federal patent law have expired;

            (ii)    1.    That appears on the Model List of Essential Medicines most recently adopted by the World Health Organization; or

                2.    That has been designated by the Secretary as an essential medicine due to its efficacy in treating a life–threatening health condition or a chronic health condition that substantially impairs an individual’s ability to engage in activities of daily living;

            (iii)    That is actively manufactured and marketed for sale in the United States by three or fewer manufacturers; and

            (iv)    That is made available for sale in the State.

        (2)    “Essential off–patent or generic drug” includes any drug–device combination product used for the delivery of a drug for which all exclusive marketing rights, if any, granted under the Federal Food, Drug, and Cosmetic Act, § 351 of the federal Public Health Service Act, and federal patent law have expired.

    (c)    “Price gouging” means an unconscionable increase in the price of a prescription drug.

    (d)    “State health plan” has the meaning stated in § 2–601 of this title.

    (e)    “State health program” has the meaning stated in § 2–601 of this title.

    (f)    “Unconscionable increase” means an increase in the price of a prescription drug that:

        (1)    Is excessive and not justified by the cost of producing the drug or the cost of appropriate expansion of access to the drug to promote public health; and

        (2)    Results in consumers for whom the drug has been prescribed having no meaningful choice about whether to purchase the drug at an excessive price because of:

            (i)    The importance of the drug to their health; and

            (ii)    Insufficient competition in the market for the drug.

    (g)    “Wholesale acquisition cost” has the meaning stated in 42 U.S.C. § 1395w–3a.