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HR 4384 112th Congress House Health Consumer affairs Drug safety, medical device, and laboratory regulation Health information and medical records Prescription drugs

Patient Safety and Drug Labeling Improvement Act

Introduced: April 18, 2012 Introduced by: Van Hollen, Chris Democratic · Maryland See on congress.gov
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This bill died when the 112th Congress ended
It never became law before the 112th Congress (2011–2012) 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
Apr 20, 2012
Referred to the Subcommittee on Health.
Apr 18, 2012
Referred to the House Committee on Energy and Commerce.
Apr 18, 2012
Introduced in House
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 Plain-English summary Congressional Research Service

Patient Safety and Drug Labeling Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act to allow the holder of an approved abbreviated new drug application (generic drug approval) to change the labeling of a drug so approved in the same manner authorized by regulation for the holder of an approved new drug application.

Allows conforming changes to be ordered to the labeling of the equivalent listed drug and each drug approved under the abbreviated new drug application process that corresponds to such listed drug.

What's happening now April 20, 2012

Referred to the Subcommittee on Health.

 Related & companion bills 1
  • S 2295 Related bill Patient Safety and Generic Labeling Improvement 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. 4384: Patient Safety and Drug Labeling Improvement Act. 112th Congress. Open America. https://openamerica.io/bill/112-HR-4384/
MLA
"H.R. 4384: Patient Safety and Drug Labeling Improvement Act." 112th Congress, 2026, Open America, https://openamerica.io/bill/112-HR-4384/.
Bluebook (legal)
H.R. 4384, 112th Cong. (2026), https://openamerica.io/bill/112-HR-4384/.
Markdown link
[H.R. 4384: Patient Safety and Drug Labeling Improvement Act](https://openamerica.io/bill/112-HR-4384/)
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