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
Floor votes
How they voted
No floor votes recorded yet.
Full legislative history
Actions timeline
Total actions
2
Key actions
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
Sponsors
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