[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3648 Introduced in House (IH)]

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114th CONGRESS
  1st Session
                                H. R. 3648

To amend the Federal Food, Drug, and Cosmetic Act to require the label 
 of drugs intended for human use to contain a parenthetical statement 
identifying the source of any ingredient constituting or derived from a 
                 grain or starch-containing ingredient.


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                    IN THE HOUSE OF REPRESENTATIVES

                           September 29, 2015

Mr. Ryan of Ohio (for himself and Mrs. Lowey) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

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                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to require the label 
 of drugs intended for human use to contain a parenthetical statement 
identifying the source of any ingredient constituting or derived from a 
                 grain or starch-containing ingredient.

    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 ``Gluten in Medicine Disclosure Act of 
2015''.

SEC. 2. LABELING OF SOURCE OF HUMAN DRUG INGREDIENTS CONSTITUTING OR 
              DERIVED FROM A GRAIN OR STARCH-CONTAINING INGREDIENT.

    (a) Misbranding.--Section 502 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the 
following:
    ``(dd) If it is a drug--
            ``(1) that is intended for human use;
            ``(2) that contains an ingredient (other than a polyol) 
        that constitutes or is derived from a grain or starch-
        containing ingredient; and
            ``(3) whose label fails to include a parenthetical 
        statement identifying the source of the ingredient so 
        constituted or derived.''.
    (b) Applicability.--Section 502(dd) of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a) of this section, shall apply 
beginning on the sooner of--
            (1) a date to be determined by the Secretary of Health and 
        Human Services; and
            (2) the date that is 2 years after the date of the 
        enactment of this Act.
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