Sec. 308. Definitions
203 words·~1 min read·
/bill/116/hr/2452/ih/section-308A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
In this title: The term affiliate means, with respect to a manufacturer, any entity that controls, is controlled by, or is under common control with such manufacturer. The term average manufacturer price means the average price charged by the manufacturer of a prescription drug or medical device, as applicable, for sales of the drug or device by the manufacturer in the United States over the respective annual quarter. The term medical device means a device (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 )).
The term prescription drug means a drug (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 )) that is subject to section 503(b)(1) of such Act ( 21 U.S.C. 353(b)(1) ). The term manufacturer means the person— that holds the application for a drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act or the license issued under section 351 of the Public Health Service Act; or who is responsible for setting the price for the drug.
The term wholesale acquisition cost has the meaning given that term in section 1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w–3a(c)(6)(B)).
Connectionstraces to 2
Traces to 2 documents
1 reference not yet in our index
- 42 USC 1395w–3a(c)(6)(B)
Citation graph
cites case law
Cites 3Cited by 0 across 0 sources