Md. Code, Health-Gen. § 2-801
Current with changes from the 2024 Legislative Session, chs. 2--407, effective on or before 7/1/2024
Section 2-801 - Definitions(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; or2. 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.Added by 2017 Md. Laws, Ch. 818, Sec. 1, eff. 10/1/2017.