3.0.0 1483 2021-04-19T18:32:05Z 2021-04-19T18:32:05Z House H HR 2011-04-12 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. DINGELL:H.R. 1483.Congress has the power to enact this legislation pursuantto the following:This bill is enacted pursuant to the power granted toCongress under Article I, Section 8, Clause 3 of the UnitedStates Constitution.[Page H2604]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2011-04-15T20:41:04Z Referred to 2011-04-12T16:00:33Z 2011-04-15 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2011-04-12 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2011-04-12 Introduced in House IntroReferral Intro-H 9 Library of Congress 2011-04-12 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 2011-04-12 True P000034 Rep. Pallone, Frank, Jr. [D-NJ-6] FRANK PALLONE D NJ 6 2011-04-12 True D000197 Rep. DeGette, Diana [D-CO-1] DIANA DEGETTE D CO 1 2011-04-12 True M000312 Rep. McGovern, James P. [D-MA-3] JAMES MCGOVERN D MA P. 3 2011-04-14 False C001085 Rep. Clarke, Hansen [D-MI-13] Hansen Clarke D MI 13 2011-04-14 False C001036 Rep. Capps, Lois [D-CA-23] LOIS CAPPS D CA 23 2011-04-14 False S000480 Rep. Slaughter, Louise McIntosh [D-NY-28] LOUISE SLAUGHTER D NY M. 28 2011-05-02 False S000810 Rep. Stark, Fortney Pete [D-CA-13] PETE STARK D CA 13 2011-05-05 False S001175 Rep. Speier, Jackie [D-CA-12] Jackie Speier D CA 12 2011-07-07 False J000283 Rep. Jackson, Jesse L., Jr. [D-IL-2] JESSE JACKSON D IL L. 2 2011-09-07 False R000515 Rep. Rush, Bobby L. [D-IL-1] BOBBY RUSH D IL L. 1 2011-09-07 False A000022 Rep. Ackerman, Gary L. [D-NY-5] GARY ACKERMAN D NY L. 5 2012-02-01 False N000147 Del. Norton, Eleanor Holmes [D-DC-At Large] ELEANOR NORTON D DC HOLMES 0 2012-02-17 False L000551 Rep. Lee, Barbara [D-CA-9] BARBARA LEE D CA 9 2012-03-05 False K000009 Rep. Kaptur, Marcy [D-OH-9] MARCY KAPTUR D OH 9 2012-03-22 False 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 2011-04-12 Introduced in House 2011-06-21T20:23:32Z 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.

]]> Drug Safety Enhancement Act of 2011 Short Titles as Introduced Drug Safety Enhancement Act of 2011 Display Title Drug Safety Enhancement Act of 2011 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs, and for other purposes. Introduced in House 2011-04-12T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr1483ih/xml/BILLS-112hr1483ih.xml 2011-04-15 Referred to the Subcommittee on Health. 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.