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Maryland Code, Health-General § 2-801

Current as of January 01, 2025 | Updated by Findlaw Staff

(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.

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Cite this article: FindLaw.com - Maryland Code, Health-General § 2-801 - last updated January 01, 2025 | https://codes.findlaw.com/md/health-general/md-code-health-gen-sect-2-801/

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