S. 2595: Drug Shortages Prevention and Quality Improvement Act

117th Congress · introduced 2021-08-04 · Health · Latest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

federal

Follow this bill, step by step

Where it came from: introduced 2021-08-04 · official record
Who proposed it: Sen. Cardin, Benjamin L. [D-MD] · what a sponsor is
What happened next: no floor votes in our records yet. Why?
Where it stands now: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Not final yet: this can still change. We check for updates every day.
If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

Drug Shortages Prevention and Quality Improvement Act

Plain summary

Drug Shortages Prevention and Quality Improvement Act This bill addresses shortages of essential drugs and related issues. (Generally, an essential drug is one that is life-supporting, life-sustaining, or intended to treat or prevent a debilitating condition.) The Food and Drug Administration (FDA) may require a manufacturer of an essential drug to (1) submit data, or conduct studies to gather data, to determine the longest supported expiration date of a drug; or (2) make labeling changes regarding a drug's expiration period based on data provided under this bill or otherwise available to the FDA. The bill establishes civil monetary penalties for a manufacturer that (1) refuses such a request to provide data or modify a drug label's expiration information, or (2) fails to meet certain requirements to provide to the FDA timely information about essential drug shortages. The Government Accountability Office must conduct a study examining the process by which prescription drug manufacturers provide shelf life data to the FDA. The FDA must establish a pilot program to assess the facilities and processes of participating manufacturers of prescription sterile injectable drugs that have been deemed essential under a specified executive order. The assessment shall cover topics including supply chain management, manufacturing strategy and operations, and workforce management. Furthermore, the FDA must provide grants to certain nonprofit entities and institutions of higher education that agree to participate in the above pilot program. The grant funds must be used to upgrade the recipient's drug manufacturing facilities to utilize advanced manufacturing capabilities.

Congressional Research Service summary (Introduced in Senate), quoted unchanged (nonpartisan). Read the source.

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A “Nay” vote

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What does this mean? (plain words)

Official text

Drug Shortages Prevention and Quality Improvement Act

Source: Congressional Research Service summary (Introduced in Senate)

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Sen. Cardin, Benjamin L. [D-MD] · 1 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Tina Smith (D-MN)

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (1)

Bill: A proposed law. It becomes law only if it passes the legislature and is signed by the president or governor (or a veto is overridden).

Plain meanings written from linked sources. All words.

Sources

Congressional Research Service summary (Introduced in Senate)
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-117s2595.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/117/s>

Record fed-us-cong117-s2595 · catalog fed-us-congress-bills-cong117 · updated 2026-11-15 by psicol fed-bills-cong117