II
117th CONGRESS
2d Session
S. 3449
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.
Short title
This Act may be cited as the Registration of Certain Foreign Establishments Act
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Registration of certain foreign establishments
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:
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.
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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).