Skip to main content
HR 9011 117th Congress House

Updated Drug Labeling for Patient Safety Act

Official title: To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to establish a process to allow the holders of abbreviat… Show full official titleShow less

Official title: To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to establish a process to allow the holders of abbreviated new drug applications to make labeling changes to include new or updated safety-related information, and for other purposes.

Introduced: September 28, 2022 See on congress.gov
Health Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationPrescription drugs
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
Sep 29, 2022
Referred to the Subcommittee on Health.
Sep 28, 2022
Referred to the House Committee on Energy and Commerce.
Sep 28, 2022
Introduced in House
 Ask about this bill AI · grounded in the bill text

Have a question about what this bill does? Ask in plain English; the answer is drawn from the bill's actual text and official record, and it'll tell you when something isn't in the text rather than guess.

AI answers can be imperfect; always confirm against the full bill text.

 Latest action September 29, 2022

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

Updated Drug Labeling for Patient Safety Act

This bill allows generic drug manufacturers to revise labels with updated safety information that differs from the referenced brand-name drug.

 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. 9011: Updated Drug Labeling for Patient Safety Act. 117th Congress. Open America. https://openamerica.io/bill/117-HR-9011/
MLA
"H.R. 9011: Updated Drug Labeling for Patient Safety Act." 117th Congress, 2026, Open America, https://openamerica.io/bill/117-HR-9011/.
Bluebook (legal)
H.R. 9011, 117th Cong. (2026), https://openamerica.io/bill/117-HR-9011/.
Markdown link
[H.R. 9011: Updated Drug Labeling for Patient Safety Act](https://openamerica.io/bill/117-HR-9011/)
Report a problem