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Extended Expiration Dates for Lifesaving Drugs: Increased Access and Safety

This act aims to ensure that life-saving drugs remain available for longer periods by requiring manufacturers to test and confirm their longest possible expiration dates. This means less waste and greater assurance that necessary medications will be accessible, especially during crises or when shortages occur. Manufacturers who fail to comply with these rules may face financial penalties.
Key points
Manufacturers of life-saving drugs must test and submit data to determine the longest possible expiration dates for their products.
The act applies to critical emergency drugs, drugs on the shortage list, and those essential for life support or treating debilitating conditions.
It introduces financial penalties for manufacturers who fail to provide required data or update labels according to new guidelines.
The goal is to increase drug availability and reduce shortage risks, directly impacting citizens' health and safety.
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Additional Information
Ensuring Access to Lifesaving Drugs Act of 2023
Print number: HR 3793
Sponsor: Rep. Slotkin, Elissa [D-MI-7]
Process start date: 2023-06-05