What is the official ID of this bill?
The official print number for this legislation is HR 3008.
Drug Shortage Prevention: Early Warning for Increased Demand of Critical Medicines.
This Act aims to protect citizens from sudden shortages of life-saving or essential medicines for serious conditions. It mandates manufacturers to notify authorities not only of production interruptions but also of significant increases in demand for critical drugs. This allows the government and healthcare providers to react faster, minimizing the risk of patients being deprived of necessary treatments.
Key points
Mandatory Reporting of Increased Demand: Manufacturers must inform authorities about increased demand for critical essential medicines if it lasts for at least 6 consecutive weeks and is likely to lead to a shortage.
Early Warning System: Notification of production discontinuation or increased demand must be submitted in advance (6 months or within 48 hours of identifying the demand surge), allowing time to secure alternative supplies.
Definition of Critical Medicines: The Act defines critical essential medicines as those that are life-supporting, life-sustaining, or intended for debilitating diseases, including nonprescription drugs.
Increased Transparency: Manufacturers must provide reasons for interruptions or demand increases, including information on the source of active ingredients and any alternative sources.
Status:
Expired
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