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Bill > S3449


US S3449

US S3449
Registration of Certain Foreign Establishments Act


summary

Introduced
01/10/2022
In Committee
01/10/2022
Crossed Over
Passed
Dead
01/03/2023

Introduced Session

117th Congress

Bill Summary

A BILL To require foreign establishments engaged in the manufac- ture, preparation, propagation, compounding, or proc- essing 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.

AI Summary

This bill, the Registration of Certain Foreign Establishments Act, requires foreign establishments engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device to register with the Food and Drug Administration (FDA), 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. The bill also requires the Secretary of Health and Human Services to update regulations, as appropriate, to implement this amendment to the existing law.

Committee Categories

Health and Social Services

Sponsors (2)

Last Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (on 01/10/2022)

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