Sec. 201. Prescription drug importation
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Section 804(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 384(b) ) is amended by striking The Secretary, and inserting The Secretary, not later than January 1, 2016, . Section 804 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 384 ) is amended— in subsection (f), by striking within Canada ; in subsection (j)— in paragraph (1), in the matter preceding subparagraph (A), by inserting from countries other than Canada after devices ; and in paragraph (3)— in the heading, by striking and inserting from Canada ; and from countries other than Canada in subparagraph (C), by striking from Canada, ; and by striking subsection
(l)and inserting the following: Individuals may import from Canada any prescription drug that meets the requirements of subparagraphs
(A)through
(F)of subsection (j)(3). . Not later than January 1, 2016, the Secretary of Health and Human Services shall promulgate regulations with respect to subsection
(l)of section 804 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 384 ) (as amended by paragraph (1)(B)). The amendments made by paragraph
(1)shall take effect on the effective date of the final regulations promulgated in accordance with paragraph (2). Subsection
(c)of section 708 of the Food and Drug Administration Safety and Innovation Act ( Public Law 112–144 ; 126 Stat. 1068) is amended by striking The amendment made by and all that follows through the period at the end and inserting The amendment made by subsection
(a)and the regulations promulgated under subsection
(b)shall apply beginning on the effective date of the regulations promulgated under section 804(b) of the Federal Food, Drug, and Cosmetic Act ( . 21 U.S.C. 384(b) ) and the amendments made by section 201(b) of the Prescription Drug Affordability Act of 2015 .
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- Pub. L. 112-144
- 126 Stat. 1068
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