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United States · Bill · HR

H.R. 6543 (111th)

Drug Safety Enhancement Act of 2011

referredUnited States· United States Congress· EN

Introduced

17 December 2010

Last action

17 December 2010 · Introduced

Status

Referred to the House Committee on Energy and Commerce.

Sponsors

Rep. Dingell, John D. [D-MI-12], Rep. Waxman, Henry A. [D-CA-33], Rep. Pallone, Frank [D-NJ-6], Rep. Stupak, Bart [D-MI-1]

Subjects

Healthcare

Source updated

14 August 2025

Healthcare

Official sourceDownload fileView documentsShare

Summary

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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

  1. 17 December 2010

    Introduced

    Introduced in House

    Source: IntroReferral

  2. 17 December 2010

    Introduced

    Referred to the House Committee on Energy and Commerce.

    Source: IntroReferral

  3. 17 December 2010

    Introduced

    Introduced in House

    Source: IntroReferral

Votes

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Versions

Documents

3 official files

Introduced in House (text)

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  • Introduced in House (text)

    Introduced in House · EN · 17 December 2010

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  • Introduced in House (PDF)

    Introduced in House · EN · 17 December 2010

    ViewDownloadOpen at official source

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  • Introduced in House

    summary · EN · 17 December 2010

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Sponsors

Related records

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Sources

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