S 2362 United States Senate · 118th Congress

Drug Shortage Prevention Act of 2023

This bill requires drug manufacturers to notify the FDA (Secretary) about potential shortages of critical drugs - defined as life-saving, life-sustaining, or essential for treating debilitating conditions - up to six months in advance for planned disruptions, or within 10 business days for sudden issues like supply chain problems or increased demand. Notifications must include reasons for shortages, expected duration, alternative ingredient sources, and details about related medical devices. Manufacturers must also submit annual reports (in March and September) detailing their supply chains, including supplier names and drug production quantities for critical ingredients. The bill directly affects manufacturers of these "covered drugs" by mandating transparent reporting to prevent shortages.
Bill status in committee 1 of 4 stages cleared
Introduction
Jul 2023
Committee Review
Floor Vote
President
Introduced Jul 18, 2023 Last action Jul 18, 2023
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Total actions
2
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0
Committee
1
Jul 18, 2023
Committee
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
upper
Jul 18, 2023
Introduced
Introduced in Senate
upper
1 primary · 6 co-sponsors

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