S. 3449Senate117th Congress (2021-2023)In Committee

Registration of Certain Foreign Establishments Act

AI-Generated Summary

Updated February 8, 2026 at 8:46 AM UTC

The bill requires any foreign establishment that manufactures, prepares, propagates, compounds, or processes a drug or medical device to register with the U.S. Food and Drug Administration, even if the product is later further processed at another foreign site before being imported. This expands FDA registration requirements to cover the entire foreign supply chain and applies to all foreign drug and device manufacturers whose products enter the United States.

Key Provisions

Amends the Federal Food, Drug, and Cosmetic Act (Section 510(i)) to add a new paragraph stating that registration requirements apply regardless of any additional manufacturing or processing steps performed abroad before import.
Directs the Secretary of Health and Human Services to update related regulations within two years of the law’s enactment to implement the new registration rule.

Legislative Activity

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1 earlier action

SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

January 10, 2022

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SenateIntro Referral

Introduced in Senate

January 10, 2022

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

January 10, 2022

Bill Text

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Introduced in SenateIssued January 10, 2022

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.

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).