Sec. 6. Definitions
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/bill/116/hr/5039/ih/section-6A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
For the purposes of this Act: The term average manufacturer price , with respect to a drug, subject to subparagraph (B), has the meaning given such term in section 1927(k)(1) of the Social Security Act ( 42 U.S.C. 1396r–8(k)(1) ); or with respect to a drug for which there is no average manufacturer price as so defined, such term shall mean the wholesale acquisition cost (as defined in section 1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w–3a(c)(6)(B)) of the drug.
With respect to reference countries, the term average manufacturer price , as defined in subparagraph (A), shall be determined based on the price of the drug in the applicable reference country. The term biosimilar biological product means a biological product licensed pursuant to an application under section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ). The term generic drug means a drug approved pursuant to an application under section (b)(2) or
(j)of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ). The term life-sustaining prescription drug means a drug that is— approved under subsection
(c)or
(j)of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or a biological product licensed under subsection
(a)or
(k)of section 351 of the Public Health Service Act ( 42 U.S.C. 262 ); subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(b)(1) ); and life-sustaining (as such term is defined in regulation pursuant to section 506C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c )). The term manufacturer means the holder of an application approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or of a license issued under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ). The term Secretary means the Secretary of Health and Human Services.
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- 42 USC 1396r–8(k)(1)
- 42 USC 1395w–3a(c)(6)(B)
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Sec. 6
Definitions
Cite42 USC 1396r–8(k)(1)
Cite42 USC 1395w–3a(c)(6)(B)
Cites 6Cited by 0 across 0 sources