Page:United States Statutes at Large Volume 120.djvu/91

 120 STAT. 60

PUBLIC LAW 109–171—FEB. 8, 2006 (2) by striking ‘‘or’’ at the end of subparagraph (B) and inserting ‘‘and’’; and (3) by adding at the end the following new subparagraph: ‘‘(C) with respect to covered outpatient drugs described in section 1927(a)(7), unless information respecting utilization data and coding on such drugs that is required to be submitted under such section is submitted in accordance with such section; or’’. SEC. 6003. IMPROVED REGULATION OF DRUGS SOLD UNDER A NEW DRUG APPLICATION APPROVED UNDER SECTION 505(c) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.

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VerDate 14-DEC-2004

10:20 Jul 12, 2007

(a) INCLUSION WITH OTHER REPORTED AVERAGE MANUFACTURER AND BEST PRICES.—Section 1927(b)(3)(A) of the Social Security Act (42 U.S.C. 1396r–8(b)(3)(A)) is amended— (1) by striking clause (i) and inserting the following: ‘‘(i) not later than 30 days after the last day of each rebate period under the agreement— ‘‘(I) on the average manufacturer price (as defined in subsection (k)(1)) for covered outpatient drugs for the rebate period under the agreement (including for all such drugs that are sold under a new drug application approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act); and ‘‘(II) for single source drugs and innovator multiple source drugs (including all such drugs that are sold under a new drug application approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act), on the manufacturer’s best price (as defined in subsection (c)(1)(C)) for such drugs for the rebate period under the agreement;’’; and (2) in clause (ii), by inserting ‘‘(including for such drugs that are sold under a new drug application approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act)’’ after ‘‘drugs’’. (b) CONFORMING AMENDMENTS.—Section 1927 of such Act (42 U.S.C. 1396r–8) is amended— (1) in subsection (c)(1)(C)— (A) in clause (i), in the matter preceding subclause (I), by inserting after ‘‘or innovator multiple source drug of a manufacturer’’ the following: ‘‘(including the lowest price available to any entity for any such drug of a manufacturer that is sold under a new drug application approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act)’’; and (B) in clause (ii)— (i) in subclause (II), by striking ‘‘and’’ at the end; (ii) in subclause (III), by striking the period at the end and inserting ‘‘; and’’; and (iii) by adding at the end the following: ‘‘(IV) in the case of a manufacturer that approves, allows, or otherwise permits any other drug of the manufacturer to be sold under a new drug application approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act, shall

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