3.0.0 3026 2023-01-11T13:22:21Z 2023-01-11T13:22:21Z House H HR 2011-09-22 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. MATHESON:H.R. 3026.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3.[Page H6414]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2011-09-26T13:57:39Z Referred to 2011-09-22T14:00:43Z 2011-09-26 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2011-09-22 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2011-09-22 Introduced in House IntroReferral Intro-H 9 Library of Congress 2011-09-22 Introduced in House IntroReferral 1000 9 Library of Congress M001142 Rep. Matheson, Jim [D-UT-2] JIM MATHESON D UT 2 N B000461 Rep. Bilbray, Brian P. [R-CA-50] BRIAN BILBRAY R CA P. 50 2011-09-22 True Health Administrative law and regulatory procedures Business records Civil actions and liability Department of Health and Human Services Drug safety, medical device, and laboratory regulation Government studies and investigations Licensing and registrations Prescription drugs Retail and wholesale trades Trade restrictions Health 00 2011-09-22 Introduced in House 2011-12-09T16:18:35Z Safeguarding America's Pharmaceuticals Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of the Treasury to destroy imported counterfeit drugs and adulterated or misbranded imported drugs with a value of less than $2,000.

Requires the manufacturer of a prescription drug to provide to its wholesale distributors or dispensers a packing list or comparable document containing identifying information, including the National Drug Code number, container size, and lot number of the drug.

Requires each manufacturer or repackager of a prescription drug to: (1) apply a standardized numerical identifier that is unique to each unit of the drug to at least 50% of its drugs by January 1, 2015, and to all of its drugs by January 1, 2016; and (2) notify the Secretary of Health and Human Services (HHS) of the method it will use to meet such requirement.

Requires the Secretary to establish an effective drug identification and tracking system to authenticate the wholesale distribution history of any prescription drug that is subject to a requirement for a standardized numerical identifier.

Expands the requirements for the licensing of wholesale distributors, including to require mandatory background checks. Disqualifies a person who has been convicted of certain felonies or who has engaged in a pattern of violative behavior.

Establishes civil monetary penalties for violations of this Act. Requires penalties paid to the United States to be used by the Secretary of HHS to prevent and address unlawful counterfeiting and diversion of drugs.

Authorizes a state to enforce the requirements of this Act under certain circumstances.

Requires the Secretary of HHS to study threats to the domestic prescription drug supply chain.

]]> Safeguarding America's Pharmaceuticals Act of 2011 Display Title Safeguarding America's Pharmaceuticals Act of 2011 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs. Introduced in House IH Short Titles as Introduced Safeguarding America's Pharmaceuticals Act of 2011 Introduced in House 2011-09-22T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr3026ih/xml/BILLS-112hr3026ih.xml 2011-09-26 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.