[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2500 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 2500

  To amend the Federal Food, Drug, and Cosmetic Act to expand certain 
  authorities with respect to the recall of controlled substances to 
        apply with respect to all drugs, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 6, 2023

Mr. Kim of New Jersey introduced the following bill; which was referred 
                to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
  To amend the Federal Food, Drug, and Cosmetic Act to expand certain 
  authorities with respect to the recall of controlled substances to 
        apply with respect to all drugs, 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 ``Protecting Americans from Unsafe 
Drugs Act of 2023''.

SEC. 2. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF DRUGS.

    (a) Order To Cease Distribution and Recall.--Section 569D of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-8d) is amended--
            (1) in the section heading, by striking ``controlled 
        substances'' and inserting ``drugs'';
            (2) by striking ``controlled substance'' each place such 
        term appears and inserting ``drug'';
            (3) in subsection (b)--
                    (A) by striking ``controlled substances'' and 
                inserting ``drugs''; and
                    (B) by inserting ``of subsection (a)'' after ``an 
                order pursuant to paragraph (1) or an amended order 
                pursuant to subparagraph (B) or (C) of paragraph (3)''; 
                and
            (4) in subsection (c), by striking ``or an official senior 
        to such Director'' and inserting ``or the Director of the 
        Center for Biologics Evaluation and Research (or an official 
        senior to either such Director)''.
    (b) Imports and Exports.--Section 801(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 381(a)) is amended by striking ``is a 
controlled substance subject to an order under section 569D'' and 
inserting ``is a drug subject to an order under section 569D''.
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