As used in this Act:

"Essential off-patent or generic drug" means any prescription drug sold within the State:

1. (1) for which all exclusive marketing rights, if any, granted under the Federal Food, Drug, and Cosmetic Act, Section 351 of the federal Public Health Service Act, and federal patent law have expired;
2. (2) that appears on the model list of essential medicines most recently adopted by the World Health Organization or that has been designated by the United States Secretary of Health and Human Services 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; and

3. (3) that is actively manufactured and marketed for sale in the United States by 3 or fewer manufacturers. "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, Section 351 of the federal Public Health Service Act, and federal patent law have expired.

   "Manufacturer" has the meaning provided in Section 15 of the Wholesale Drug Distribution Licensing Act. "Manufacturer" does not include an entity operating as a wholesale drug distributor as defined in Section 15 of the Wholesale Drug Distribution Licensing Act.

   "Price gouging" means an unconscionable increase in a prescription drug's price that:

4. (1) would result in the wholesale acquisition cost of a 30-day supply of the essential off-patent or generic drug exceeding $20 and would result in an increase in the wholesale acquisition cost of the essential off-patent or generic drug of:

   1. (A) 30% or more within the preceding year;
   2. (B) 50% or more within the preceding 3 years; or
   3. (C) 75% or more within the preceding 5 years; and
5. (2) is otherwise excessive and unduly burdens consumers because of the importance of the essential off-patent or generic drug to their health and because of insufficient competition in the marketplace. "Price gouging" does not include a price increase that can be reasonably justified by:
6. (1) an increase in the cost of producing the essential off-patent or generic drug; or

7. (2) the cost of appropriate expansion of access to the essential off-patent or generic drug to promote public health. "State health plan" means the program of health benefits under the State Employees Group Insurance Act of 1971.

   "Wholesale acquisition cost" has the meaning provided in 42 U.S.C. 1395w-3a.

   "Wholesale drug distributor" has the meaning provided in Section 15 of the Wholesale Drug Distribution Licensing Act.

(Source: P.A. 103-367, eff. 1-1-24.)