H.R. 1483 (112th): Drug Safety Enhancement Act of 2011

Apr 12, 2011 (112th Congress, 2011–2013)
Died (Referred to Committee)
John Dingell
Representative for Michigan's 15th congressional district
Read Text »
Last Updated
Apr 12, 2011
87 pages
Related Bills
H.R. 6543 (111th) was a previous version of this bill.

Referred to Committee
Last Action: Dec 17, 2010


This bill was introduced on April 12, 2011, in a previous session of Congress, but was not enacted.

Introduced Apr 12, 2011
Referred to Committee Apr 12, 2011
Full Title

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


No summaries available.

15 cosponsors (15D) (show)

House Energy and Commerce


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Primary Source

THOMAS.gov (The Library of Congress)

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H.R. stands for House of Representatives bill.

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The bill’s title was written by its sponsor.

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.

Drug Safety Enhancement Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand drug establishment registration requirements to include foreign drug establishments and establishments manufacturing, preparing, propagating, compounding, or processing excipients of drugs (i.e., inactive drug additives). Requires the Secretary of Health and Human Services (HHS) to collect registration fees.
Requires drug manufacturers to: (1) implement an effective quality system that requires compliance with current good manufacturing practices and timely communication of product quality issues; (2) establish risk management procedures that ensure effective risk assessment, control, and communication; and (3) establish procedures that ensure the safety, identity, quality, strength, purity, and security of all drugs and other materials used by the manufacturer.
Requires drug establishments to maintain records on the supply chain of the drug, ingredients, and raw materials.
Establishes the frequency of inspections of drug establishments. Prohibits delaying or limiting an inspection.
Gives the Secretary authority to order the recall of, detain, destroy, and seize drugs as necessary.
Establishes civil and criminal penalties for violations of FFDCA provisions.
Authorizes the Secretary to require documentation of an imported drug and refuse admission if such documentation is not provided.
Requires the Secretary to: (1) require drug importers to register and to comply with good importer practices, (2) require a customs broker with respect to drugs to register, and (3) establish a corps of inspectors dedicated to inspections of foreign drug facilities and establishments.
Requires drug establishments, importers, and customs brokers to have a unique identifier.
Deems a finished dosage form drug to be misbranded if the manufacturer's website does not list country of origin labeling for each active pharmaceutical ingredient and the place of manufacture of the finished dosage form of such drug.
Gives the Commissioner of the Food and Drug Administration (FDA) subpoena authority.
Establishes whistleblower protections.

House Republican Conference Summary

The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.

No summary available.

House Democratic Caucus Summary

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