Title: Protecting Americans from Unsafe Drugs Act of 2022
Policy area: Health

Summary:
Protecting Americans from Unsafe Drugs Act of 2022
This bill expands the authority of the Secretary of the Department of Health and Human Services (HHS) to order the recall of controlled substances to cover all drugs.
Furthermore, the authority to issue such an order may be delegated to the Director of the Center for Drug Evaluation and Research or the Director of the Center for Biologics Evaluation and Research (or an official senior to either director), whereas currently this authority may only be delegated to the Director of the Center for Drug Evaluation and Research or an official senior to such director. (Both centers are located in the Food and Drug Administration within HHS.)

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6545 Introduced in House (IH)]

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117th CONGRESS
  2d Session
                                H. R. 6545

  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

                            February 1, 2022

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 2022''.

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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