H.R. 6543 (111th): Drug Safety Enhancement Act of 2011

Introduced:
Dec 17, 2010 (111th Congress, 2009–2010)
Sponsor:
Rep. John Dingell [D-MI15]
Status:
Died (Referred to Committee)
See Instead:
This bill was re-introduced as H.R. 1483 (112th) on Apr 12, 2011.

The bill’s title was written by the bill’s sponsor. H.R. stands for House of Representatives bill.

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Status

This bill was introduced on December 17, 2010, in a previous session of Congress, but was not enacted.

Progress
Introduced Dec 17, 2010
Cosponsors
3 cosponsors (3D) (show)
Committees

House Energy and Commerce

The committee chair determines whether a bill will move past the committee stage.

Full Title

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs, and for other purposes.

Summary

No summaries available.

Text

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Last updated Dec 17, 2010.
87 pages

Primary Source

View on THOMAS (The Library of Congress)

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Citation

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GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

12/17/2010--Introduced.
Drug Safety Enhancement Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to expand safety and inspection requirements for the manufacture and importation of drugs by: (1) expanding registration requirements for foreign and domestic drug producers; (2) requiring drug manufacturers to have in effect and implement an effective quality system; (3) expanding and equalizing inspection requirements for foreign and domestic drug producers; (4) imposing additional requirements relating to the notification, nondistribution, and recall of adulterated or misbranded drugs; (5) permitting the detention of drugs found to be in violation of drug safety requirements; (6) allowing for the destruction of drugs that pose a significant adverse health effect; (7) providing enhanced civil and criminal penalties and forfeiture for violations of drug safety requirements and enhanced subpoena authority for investigating violations; (8) prohibiting the importation of drugs into the United States lacking documentation of safety; (9) requiring unique identification numbers for drug establishments and importers; and (10) expanding protections for whistleblowers who refuse to violate, or who disclose violations of, this Act.

House Republican Conference Summary

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No summary available.

House Democratic Caucus Summary

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The bill contains the following citations to other parts of U.S. law:

United States Code

The United States Code is the compilation of permanent laws enacted by Congress. Temporary and other non-permanent laws do not appear in the United States Code. (About half of the United States Code is the law itself, called positive law. The other half is merely a compilation of the laws but has no legal significance.)

Other Citations

  • 18 U.S.C. Chapter 46
  • 31 U.S.C. Chapter 37