§ 2–801
Statutes in effect as of October 1, 2026.
Md. Code Ann., Health-Gen. § 2-801 (2026)
Title 2. Maryland Department of Health
Subtitle 8. Prohibition Against Price Gouging for Essential Off-Patent or Generic Drugs
§ 2–801LinkCopy Citation
(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.