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H.R. 6483 117th Congress House

Improved Transparency of Foreign Drug Manufacturing Act of 2022

Official title: To amend the Federal Food, Drug, and Cosmetic Act to clarify reporting requirements for establishments within a foreign country engaged in the manufacture, pre… Show full official titleShow less

Official title: To amend the Federal Food, Drug, and Cosmetic Act to clarify reporting requirements for establishments within a foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of an active pharmaceutical ingredient, and for other purposes.

Introduced: January 25, 2022 See on congress.gov
Health
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This bill died when the 117th Congress ended
It never became law before the 117th Congress (2021–2022) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jan 26, 2022
Referred to the Subcommittee on Health.
Jan 25, 2022
Referred to the House Committee on Energy and Commerce.
Jan 25, 2022
Introduced in House
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 Latest action January 26, 2022

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

Improved Transparency of Foreign Drug Manufacturing Act of 2022

This bill modifies requirements for certain foreign establishments that manufacture drugs (including active pharmaceutical ingredients) to register with the Food and Drug Administration (FDA).

Under this bill, if an establishment outside of the United States manufactures (or otherwise processes or prepares) a drug to be imported (or offered for import) into the United States, the establishment must comply with the registration requirements even if the drug undergoes further manufacturing at another non-U.S. establishment prior to importation into the United States.

A non-U.S. manufacturing establishment must also file with the FDA a list of drugs manufactured by the establishment. For each drug on the list, the establishment must (1) identify every other known establishment where additional manufacturing is performed, and (2) notify each foreign establishment involved of the listing of the drug and the obligation to register with the FDA.

The bill also requires each registered non-U.S. manufacturing establishment to report every three months to the FDA a list of each drug it manufactures for commercial distribution, where currently this report is required once a year.

 Related & companion bills 1
  • S 1366 Pharmaceutical Supply Chain Defense and Enhancement Act
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. 117th Congress. Open America. https://openamerica.io/bill/117-HR-6483/
MLA
"H.R. 6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022." 117th Congress, 2026, Open America, https://openamerica.io/bill/117-HR-6483/.
Bluebook (legal)
H.R. 6483, 117th Cong. (2026), https://openamerica.io/bill/117-HR-6483/.
Markdown link
[H.R. 6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022](https://openamerica.io/bill/117-HR-6483/)
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