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; 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.

f 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.