Sec. 201 Prescription drug importation
Importation by pharmacists and wholesalers— 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,”.
Importation by individuals—
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 “from Canada” and inserting “from countries other than Canada”; and
in subparagraph (C), by striking “from Canada,”; and
by striking subsection (l) and inserting the following:
“(l) Importation of prescription drugs from Canada—Individuals may import from Canada any prescription drug that meets the requirements of subparagraphs (A) through (F) of subsection (j)(3).”
Regulations— 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)).
Effective date— The amendments made by paragraph (1) shall take effect on the effective date of the final regulations promulgated in accordance with paragraph (2).
FDASIA amendment— 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.”.