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Preventing shortages of critical drugs: faster reporting and supply chain transparency.

This law aims to prevent shortages of essential medicines, such as life-saving or emergency drugs. It requires manufacturers to quickly notify the government not only of production interruptions but also of sudden demand increases, allowing for earlier preventive action. Citizens will benefit from greater certainty regarding the availability of necessary treatments.
Key points
Manufacturers must report the risk of shortage for critical drugs (e.g., life-saving ones) within 10 business days if the cause is a sudden increase in demand or export restrictions.
Supply chains for key drug ingredients (APIs) must be reported twice a year, increasing transparency and supply stability.
The government must share information about potential drug shortages with patient and healthcare provider organizations for better preparation.
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Additional Information
Print number: 118_S_2362
Sponsor: Sen. Klobuchar, Amy [D-MN]
Process start date: 2023-07-18