H.R.5839 - Safeguarding America's Pharmaceuticals Act of 2008

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs. view all titles (2)

All Bill Titles

  • Short: Safeguarding America's Pharmaceuticals Act of 2008 as introduced.
  • Official: To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs. as introduced.

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Introduced
 
House
Passes
 
Senate
Passes
 
President
Signs
 

 
04/17/08
 
 
 
 
 
 
 

Official Summary

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 p

Official Summary

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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