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H.R. 3008 · 118th Congress

Drug Shortage Prevention Act of 2023

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Never voted on. It didn't reach a floor vote before the 118th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

SJD JacobsSponsor
49 cosponsors · 47 D, 2 R

This bill requires drug manufacturers to notify the Food and Drug Administration (FDA) if there is an increased demand for certain critical essential medicines that may result in a shortage.

What it does: CRS summary · Introduced in House · Apr 28, 2023

Drug Shortage Prevention Act of 2023

This bill requires drug manufacturers to notify the Food and Drug Administration (FDA) if there is an increased demand for certain critical essential medicines that may result in a shortage.

Currently, drug manufacturers are required to notify the FDA in the event of a discontinuation or interruption in the supply of prescription drugs that are life-supporting, life-sustaining, or used for a debilitating disease or condition, including those used in medical emergencies, surgeries, or public health emergencies.

The bill requires drug manufacturers to also notify the FDA if there is an increased demand for such drugs that lasts for at least six weeks and that may result in a shortage. Manufacturers must initially notify the FDA of the increased demand within 48 hours after this six-week period and must submit an additional notice within 30 days of the initial notification. The notice must include the reasons for the increased demand, the expected duration, and any other information the FDA requires. The bill's requirements apply to both prescription and nonprescription drugs.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: Drug Shortage Prevention Act of 2023

Latest action (May 5, 2023): Referred to the Subcommittee on Health.

Policy area: Health · Origin: House · Introduced: Apr 28, 2023

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.