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Strengthening Pharmaceutical Supply Chains and National Security

This act aims to enhance the security of drug supplies in the U.S. by introducing new rules on the origin of pharmaceutical ingredients and increasing transparency in their production. Citizens will gain greater assurance regarding the origin of medicines and their components, potentially impacting the availability and quality of medical products on the market.
Key points
Pharmaceutical companies will be required to annually report the sources and percentages of active and inactive ingredients in their drugs.
Information on ingredient origins will be made publicly available (in aggregate form) and provided to the Department of Defense to assess reliance on foreign manufacturers.
Inspections of drug and device manufacturing facilities will consider new risk factors, including inspections by foreign adversaries, the global number of other manufacturers of a specific drug, and a country's history of illicit drug exports.
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Additional Information
Print number: 118_HR_6112
Sponsor: Rep. Waltz, Michael [R-FL-6]
Process start date: 2023-10-26