HR 1919 · 113th Congress · Health
Safeguarding America's Pharmaceuticals Act of 2013
Bill Progress
✓
Introduced✓
Committee✓
House Vote4
Senate5
EnactedLatest: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.(2013-06-04)
Plain Language Summary
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Safeguarding America's Pharmaceuticals Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to establish requirements to facilitate the tracing of drug products through the pharmaceutical supply distribution chain. Requires the Secretary of Health and Human Services (HHS) to establish standards for the exchange of transaction information. Requires the Secretary to establish processes to: (1) provide waivers of requirements for undue economic hardship or emergency medical reasons; (2) provide waivers of requirements relating to product identifiers for prescription drug products packaged without sufficient space to bear the information; and (3) determine other prescription drug products or transactions that should be exempt from the requirements of this Act. Establishes requirements for drug manufacturers, wholesalers, dispensers, and repackagers to ensure that all prior transaction information is provided at each transfer of ownership. Requires such entities to maintain such transaction information for three years. Sets forth exceptions, including for dispensing to a patient and returns. Requires a manufacturer, wholesale distributor, dispenser, repackager, in the event of …
Summarized by Claude AI · Non-partisan · For informational purposes only
CBO Cost Estimate
Congressional Budget OfficeH.R. 1919, Safeguarding America’s Pharmaceuticals Act of 2013
May 31, 2013As ordered reported by the House Committee on Energy and Commerce on May 15, 2013
Full CBO report ↗H.R. 1919, Safeguarding America’s Pharmaceuticals Act of 2013
Jun 3, 2013Estimate of the Statutory Pay-As-You-Go Effects for H.R. 1919, as Provided to CBO on May 31, 2013
Full CBO report ↗Official non-partisan budget analysis by the Congressional Budget Office
Cosponsors (20)
5 Democrats15 Republicans