3.0.0 6543 2023-01-11T13:21:12Z 2023-01-11T13:21:12Z House H HR 2010-12-17 111 hsif00 Energy and Commerce Committee House Standing Referred to 2010-12-17T14:01:25Z 2010-12-17 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2010-12-17 Introduced in House IntroReferral Intro-H 9 Library of Congress 2010-12-17 Introduced in House IntroReferral 1000 9 Library of Congress D000355 Rep. Dingell, John D. [D-MI-15] JOHN DINGELL D MI D. 15 N W000215 Rep. Waxman, Henry A. [D-CA-30] HENRY WAXMAN D CA A. 30 2010-12-17 True P000034 Rep. Pallone, Frank, Jr. [D-NJ-6] FRANK PALLONE D NJ 6 2010-12-17 True S001045 Rep. Stupak, Bart [D-MI-1] BART STUPAK D MI 1 2010-12-17 True Health Administrative law and regulatory procedures Administrative remedies Business records Civil actions and liability Criminal procedure and sentencing Department of Health and Human Services Drug safety, medical device, and laboratory regulation Employment discrimination and employee rights Evidence and witnesses Executive agency funding and structure Government information and archives Government studies and investigations Jurisdiction and venue Licensing and registrations Manufacturing Trade restrictions User charges and fees Health

00 2010-12-17 Introduced in House 2011-01-26T18:23:26Z 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.

]]>

Display Title Official Title as Introduced Introduced in House IH Short Titles as Introduced Introduced in House 2010-12-17T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-111hr6543ih/xml/BILLS-111hr6543ih.xml 2010-12-17 Referred to the House Committee on Energy and Commerce. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.