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S. 3449: Registration of Certain Foreign Establishments Act


The text of the bill below is as of Jan 10, 2022 (Introduced).


II

117th CONGRESS

2d Session

S. 3449

IN THE SENATE OF THE UNITED STATES

January 10, 2022

(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.

1.

Short title

This Act may be cited as the Registration of Certain Foreign Establishments Act.

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).