[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2435 Introduced in House (IH)]

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117th CONGRESS
  1st Session
                                H. R. 2435

To amend the Federal Food, Drug, and Cosmetic Act to require the label 
  of a drug that is intended for human use and contains an ingredient 
 that is derived directly or indirectly from a gluten-containing grain 
       to identify each such ingredient, and for other purposes.


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                    IN THE HOUSE OF REPRESENTATIVES

                             April 8, 2021

 Mr. Ryan (for himself and Mr. Stivers) 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 a drug that is intended for human use and contains an ingredient 
 that is derived directly or indirectly from a gluten-containing grain 
       to identify each such ingredient, and for other purposes.

    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 
2021''.

SEC. 2. LABELING OF DRUGS WITH AN INGREDIENT MADE FROM A GLUTEN-
              CONTAINING GRAIN.

    (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:
    ``(gg) If it is a drug--
            ``(1) that is intended for human use;
            ``(2) that contains an ingredient that is derived directly 
        or indirectly from a gluten-containing grain (including wheat, 
        barley, rye, and their crossbred hybrids); and
            ``(3) whose label fails--
                    ``(A) to state that the drug contains such an 
                ingredient; and
                    ``(B) to identify each such ingredient and the type 
                of gluten-containing grain from which it is derived.''.
    (b) Applicability.--Section 502(gg) 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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