H.R. 6543 · 111th Congress
Drug Safety Enhancement Act of 2011
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Never voted on. It didn't reach a floor vote before the 111th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
DingellSponsor3 cosponsors · 3 D
3 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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)…
What it does: CRS summary · Introduced in House · Dec 17, 2010
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Drug Safety Enhancement Act of 2011
Latest action (Dec 17, 2010): Referred to the House Committee on Energy and Commerce.
Policy area: Health · Origin: House · Introduced: Dec 17, 2010
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.