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

Dec 17, 2010 (111th Congress, 2009–2010)
Died (Referred to Committee)
John Dingell
Representative for Michigan's 15th congressional district
Read Text »
Last Updated
Dec 17, 2010
87 pages
Related Bills
H.R. 1483 (112th) was a re-introduction of this bill in a later Congress.

Referred to Committee
Last Action: Apr 12, 2011


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

Introduced Dec 17, 2010
Referred to Committee Dec 17, 2010
Full Title

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


No summaries available.

3 cosponsors (3D) (show)

House Energy and Commerce

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

Primary Source

THOMAS.gov (The Library of Congress)

GovTrack gets most information from THOMAS, which is updated generally one day after events occur. Activity since the last update may not be reflected here. Data comes via the congress project.


Get a bill status widget for your website »


Click a format for a citation suggestion:


H.R. stands for House of Representatives bill.

A bill must be passed by both the House and Senate in identical form and then be signed by the president to become law.

The bill’s title was written by its sponsor.

GovTrack’s Bill Summary

We don’t have a summary available yet.

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 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

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

The House Democratic Caucus does not provide summaries of bills.

So, yes, we display the House Republican Conference’s summaries when available even if we do not have a Democratic summary available. That’s because we feel it is better to give you as much information as possible, even if we cannot provide every viewpoint.

We’ll be looking for a source of summaries from the other side in the meanwhile.

Use the comment space below for discussion of the merits of H.R. 6543 (111th) with other GovTrack users.
Your comments are not read by Congressional staff.

comments powered by Disqus