Preventing Drug Shortages: Extended Expiration Dates and Supply Chain Stability.
This Act aims to ensure continuous access to essential medications by tackling drug shortages. It mandates manufacturers of life-saving drugs to submit data to potentially extend expiration dates and requires them to report not only production interruptions but also significant demand increases that could lead to shortages. The bill also allocates funds to modernize manufacturing processes for critical drugs.
Key points
Extended Shelf Life: The FDA can require manufacturers of life-saving drugs to provide stability data to support longer expiration dates, reducing waste and mitigating shortages.
Early Shortage Warning: Manufacturers must notify the FDA within 30 days of knowing about a demand increase likely to cause a drug shortage, in addition to reporting production interruptions.
Manufacturing Grants: $1 billion is authorized for grants to upgrade facilities producing essential injectable drugs to continuous or advanced manufacturing methods, stabilizing the supply chain.
Medicare Payment Incentives: New rules allow for higher Medicare payments for drugs facing shortages, financially encouraging manufacturers to maintain a reliable supply.
Expired
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