Title: Registration of Certain Foreign Establishments Act
Policy area: Health

Summary:
Registration of Certain Foreign Establishments Act
This bill expands statutory provisions that require foreign manufacturers of drugs or medical devices for the U.S. market to register with the Food and Drug Administration.
Specifically, if an establishment outside of the United States manufactures (or otherwise processes or prepares) a drug or medical device to be imported (or offered for import) into the United States, the establishment must comply with the registration requirements even if the drug or medical device in question undergoes further manufacturing at another non-U.S. establishment prior to importation into the United States.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3449 Introduced in Senate (IS)]

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117th CONGRESS
  2d Session
                                S. 3449

     To require foreign establishments engaged in the manufacture, 
   preparation, propagation, compounding, or processing of a drug or 
device to register with the Food and Drug Administration regardless of 
whether the drug or device undergoes further manufacture, preparation, 
  propagation, compounding, or processing at a separate establishment 
   outside the United States prior to being imported into the United 
                                States.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            January 10, 2022

Mr. Peters (for himself and Ms. Collins) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
     To require foreign establishments engaged in the manufacture, 
   preparation, propagation, compounding, or processing of a drug or 
device to register with the Food and Drug Administration regardless of 
whether the drug or device undergoes further manufacture, preparation, 
  propagation, compounding, or processing at a separate establishment 
   outside the United States prior to being imported into the United 
                                States.

    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 ``Registration of Certain Foreign 
Establishments Act''.

SEC. 2. REGISTRATION OF CERTAIN FOREIGN ESTABLISHMENTS.

    (a) Registration of Certain Foreign Establishments.--Section 510(i) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(i)) is 
amended by adding at the end the following:
    ``(5) The requirements of paragraphs (1) and (2) shall apply 
regardless of whether the drug or device undergoes further manufacture, 
preparation, propagation, compounding, or processing at a separate 
establishment outside the United States prior to being imported or 
offered for import into the United States.''.
    (b) Updating Regulations.--Not later than 2 years after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
update regulations, as appropriate, to implement the amendment made by 
subsection (a).
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