[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 3633 Introduced in Senate (IS)]







110th CONGRESS
  2d Session
                                S. 3633

To amend the Federal Food, Drug, and Cosmetic Act to require country of 
      origin labeling on prescription and over-the-counter drugs.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

           September 26 (legislative day, September 17), 2008

   Mr. Brown introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to require country of 
      origin labeling on prescription and over-the-counter drugs.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Transparency in Drug Labeling Act''.

SEC. 2. COUNTRY OF ORIGIN LABELING FOR DRUGS.

    (a) In General.--Section 502 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the 
following:
    ``(aa)(1) If it is a drug subject to section 503(b)(1) in final 
dosage form, unless the labeling of such drug bears the following 2 
separate lists:
            ``(A) The identity of the country of manufacture of each 
        active ingredient of the drug, listed in descending order based 
        on the percentage of the number of active ingredients in the 
        final dosage form manufactured in such countries.
            ``(B) The identity of the country of manufacture of each 
        inactive ingredient of the drug, listed in descending order 
        based on the percentage of the number of inactive ingredients 
        in the final dosage form manufactured in such countries.
    ``(2) If it is a nonprescription drug (as defined in section 760), 
unless the label of such drug bears the following 2 separate lists:
            ``(A) The identity of the country of manufacture of each 
        active ingredient of the drug, listed in descending order based 
        on the percentage of the number of active ingredients in such 
        drug manufactured in such countries.
            ``(B) The identity of the country of manufacture of each 
        inactive ingredient of the drug, listed in descending order 
        based on the percentage of the number of inactive ingredients 
        in such drug manufactured in such countries.''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
take effect on the date that is 180 days after the date of enactment of 
this Act.
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