S.Amdt. 3691

1. Adds SEC. 1502. PAYMENT FOR ILLEGAL UNAPPROVED DRUGS at the end of subtitle F of title I

   Adds a section

   In H.R. 4872 · Placed on Calendar Senate

   Section 279(b) of the Trade Act of 1974 (19 U.S.C. 2372a(b)) is amended by striking "Supplement" and all that follows through "Funds" and inserting "There are" and by striking "pursuant" and all that follows and inserting "$500,000,000 for each of fiscal years 2011, 2012, 2013, and 2014 to carry out this subchapter, except that the limitations contained in section 278(a)(2) shall not apply to such funds and each State shall receive not less than 0.5 percent of the amount appropriated pursuant to this subsection for each such fiscal year.".

   Inserted: SEC. 1502. PAYMENT FOR ILLEGAL UNAPPROVED DRUGS.

   Inserted: (a) Listing of Drugs and Devices.--Section 510 of the Food, Drug and Cosmetic Act (21 U.S.C. 360) is amended--

   Inserted: (1) in subsection (j)(1)(B)--

   Inserted: (A) in clause (i), by inserting "in the case of a drug, the authority under this Act that does not require such drug to be subject to section 505 and section 512," after "labeling for such drug or device,"; and

   Inserted: (B) in clause (ii), by inserting ", in the case of a drug, the authority under this Act that does not require such drug to be subject to section 505 and section 512," after "for such drug or device"; and

   Inserted: (2) in subsection (f)--

   Inserted: (A) by striking "(f) The Secretary" and inserting the following:

   Inserted: "(f) Inspection by Public of Registration.--

   Inserted: "(1) In general.--The Secretary"; and

   Inserted: (B) by adding at the end the following:

   Inserted: "(2) List of drugs that are not approved under section 505 or 512.--Not later than January 1, 2011, the Secretary shall make available to the public on the Internet website of the Food and Drug Administration a list that includes, for each drug described in subsection (j)(1)(B)--

   Inserted: "(A) the drug;

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   Inserted: "(B) the person who listed such drug; and

   Inserted: "(C) the authority under this Act that does not require such drug to be subject to section 505 and section 512, as provided by such person in such list.".

   Inserted: (b) Payment for Covered Outpatient Drugs.--Section 1927 of the Social Security Act (42 U.S.C. 1396r-8) is amended by inserting at the end the following:

   Inserted: "(l) Condition.--Beginning January 1, 2011, no State shall make any payment under this section for any covered outpatient drug unless such State first verifies with the Food and Drug Administration that such covered outpatient drug has been approved by the Food and Drug Administration under a new drug application under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) or an abbreviated new drug application under section 505(j) of such Act, or that such drug is not subject to such section 505 or section 512 due to the application of section 201(p) of such Act (21 U.S.C. 321(p)). The Secretary shall have the authority to proscribe regulations to create an information sharing protocol to allow States to verify that a covered outpatient drug has been approved by the Food and Drug Administration.".

   Original wording

   At the end of subtitle F of title I, add the following:

Read automatically from the Congressional Record. Check the original before relying on it.

As printed