Safeguarding America's Pharmaceuticals Act of 2008

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

4/17/2008--Introduced.
Safeguarding America's Pharmaceuticals Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of the Treasury to destroy imported counterfeit drugs and certain adulterated or misbranded imported drugs.
Requires the manufacturer of a prescription drug to provide to each wholesale distributor or dispenser a packing list or comparable document that includes information identifying the drug's proprietary and established names and National Drug Code number.
Requires each person engaged in wholesale distribution of a prescription drug to provide information on each prior transaction involving the drug.
Requires the Secretary of Health and Human Services (the Secretary) to report to Congress on the feasibility and operational efficiencies of adopting security technologies, including track and trace technology throughout the prescription drug supply chain. Phases in requirements for standardized numerical identifiers that are unique to each unit of a prescription drug.
Requires the Secretary to issue regulations 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 such an identifier.
Requires the Comptroller General to study the availability and cost of technologies to dispensers to comply with this Act.
Requires the Secretary to:
(1) award matching grants for drug identification and tracking systems to ensure the security and integrity of the drug supply chain; and
(2) issue guidelines for wholesale distributors that prescribe requirements that include mandatory background checks and physical inspection of facilities.
Sets forth civil penalties for violations of this Act.
Requires the Secretary to study threats to the domestic prescription drug supply chain and make recommendations for improvements.


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Sponsor

• Rep. Stephen Buyer [R, IN-4]
• and 13 Co-Sponsors
  • Rep. Roscoe Bartlett [R, MD-6]
  • Rep. Brian Bilbray [R, CA-50]
  • Rep. George Butterfield [D, NC-1]
  • Michael Ferguson
  • Rep. Raymond Green [D, TX-29]
  • Duncan Hunter
  • Rep. Sheila Jackson-Lee [D, TX-18]
  • William Jefferson
  • Rep. Jim Matheson [D, UT-2]
  • Rep. Kendrick Meek [D, FL-17]
  • Rep. Michael Rogers [R, MI-8]
  • Rep. Mark Souder [R, IN-3]
  • Rep. Addison Wilson [R, SC-2]
  close

Committees

• House Energy and Commerce
• 1 more
  • House Energy and Commerce
  close

Amendments

This bill has no amendments.

Amendments to H.R.5839

Number	Status	Purpose

Bill Status

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Introduced		Voted on by House		Voted on by Senate		Considered By President		Bill Becomes Law
April 17, 2008

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All Bill Actions

• Apr 17, 2008: Referred to the Subcommittee on Health.
• Introduced on Apr 17, 2008.
• Apr 17, 2008: Referred to the House Committee on Energy and Commerce.

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Related Issue Areas:

• Medicine
• Administrative procedure
• Budgets
• Business
• 30 more
• Business records
• Congress
• Congressional investigations
• Congressional reporting requirements
• Consumers
• Cost accounting
• Criminal justice
• Department of Health and Human Services
• Drug industry
• Drugs
• Electronic data interchange
• Employee selection
• Executive departments
• Fines (Penalties)
• Government information
• Government paperwork
• Grants-in-aid
• Health policy
• Identification devices
• Identification of criminals
• Imports
• Labor
• Law
• Medical care
• Product counterfeiting
• Security measures
• Technology
• Telecommunication
• Trade
• Wholesale trade

Data from the Congressional Research Service

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In the News

May 01, 2008 US Congressmen Seek to Specify a Track-and-Trace Technology for Drugs

The sponsors hope that their bill, Safeguarding Pharmaceuticals Act of 2008 (HR 5839), will be included in the Food and Drug Administration Globalization ...

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Source: RFID Journal, NY

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April 29, 2008 Newest Drug Pedigree Proposal Highlights RFID

Steve Buyer (R-IN) introduced HR 5839 Safeguarding America's Pharmaceuticals Act of 2008 , a bill that calls for the federal government to develop drug ...

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Source: RFID Update, VA

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April 22, 2008 HIDA Welcomes the Introduction of Pedigree Reform Legislation and ...

Matthew J. Rowan, President and Chief Executive Officer of HIDA, issued the following statement on the introduction of HR 5839: "HIDA is a strong supporter ...

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Source: SunHerald.com, MS

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Blog Coverage

December 25, 2008 Pharmaceutical Commerce

A soon-to-expire piece of legislation, HR 5839, the Buyer-Matheson bill in the current Congress, is expected to be revived when the new Congress opens—a point seconded by Steven Anderson, president of NACDS, who says that his ...

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Source: Pharmaceutical Commerce

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December 25, 2008 Pharmaceutical Commerce

A soon-to-expire piece of legislation, HR 5839, the Buyer-Matheson bill in the current Congress, is expected to be revived when the new Congress opens—a point seconded by Steven Anderson, president of NACDS, who says that his ...

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Source: Pharmaceutical Commerce

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December 04, 2008 A book of common prayers ( Waltham Mass.In times of economic di...)

... Welcomes the Introduction of Pedigree Reform Legislation and Urges Congressional Support for H R 5839 17501 1HIDA Welcomes the Introduction of Pedigree Reform Legislation and Urges Congressional Support for H R 5839 17501 2Shell ...

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Source: Latest Medical News from Bio-Medicine.Org

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