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.

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117 S3449 IS: Registration of Certain Foreign Establishments Act

U.S. Senate

2022-01-10

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EN

Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

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.

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).