{"data":{"id":"us-md/md.-code-health-general-2-801","jurisdiction":"us-md","citation":"Md. Code, Health - General § 2–801","heading":"","body":"(a) In this subtitle the following words have the meanings indicated.\n(b) (1) “Essential off–patent or generic drug” means any prescription drug:\n(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;\n(ii) 1. That appears on the Model List of Essential Medicines most recently adopted by the World Health Organization; or\n2. 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;\n(iii) That is actively manufactured and marketed for sale in the United States by three or fewer manufacturers; and\n(iv) That is made available for sale in the State.\n(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.\n(c) “Price gouging” means an unconscionable increase in the price of a prescription drug.\n(d) “State health plan” has the meaning stated in § 2–601 of this title.\n(e) “State health program” has the meaning stated in § 2–601 of this title.\n(f) “Unconscionable increase” means an increase in the price of a prescription drug that:\n(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\n(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:\n(i) The importance of the drug to their health; and\n(ii) Insufficient competition in the market for the drug.\n(g) “Wholesale acquisition cost” has the meaning stated in 42 U.S.C. § 1395w–3a.","path":["Article - Health - General"],"source_url":"https://mgaleg.maryland.gov/mgawebsite/Laws/StatuteText?article=ghg\u0026section=2-801","current_through":"2026-01-01","vintage":"","retrieved_at":"2026-09-14T19:58:48Z","sha256":"5020ba3138085cbe6c3a7f4bc1f1c23228e8e6bc24414ee443108d34845e6377","source_id":"us-md","stale":false,"prev":"us-md/md.-code-health-general-2-705","next":"us-md/md.-code-health-general-2-802"},"notice":"GroundRules: Original legal text. Not legal advice."}