To address prescription drug shortages and improve the quality of prescription drugs, and for other purposes.
Analysis under review: This bill has generated analysis that may be too generic or incomplete. Clause-level evidence remains available below.
Summary
What This Bill Does
This bill, To address prescription drug shortages and improve the quality of prescription drugs, and for other purposes., changes federal law or congressional policy affecting health care providers and patients. The main policy domain is Healthcare, Education, Technology.
Who Benefits and How
health care providers and patients may benefit from new authority, funding, eligibility, regulatory clarity, or reduced risk created by the bill.
Who Bears the Burden and How
federal implementing agencies, health care providers and patients may take on implementation duties, reporting obligations, compliance costs, or oversight responsibilities.
Key Provisions
- Section idEFE4BFA67C1C48B09FA0DF5B11D99361: 1. Short title This Act may be cited as the Drug Shortages Prevention and Quality Improvement Act.
- Section idB741C264356A4DFFBEF5C4A270E14E1A: 2. Lengthen expiration dates to mitigate critical drug shortages The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 506C–1 (21...
- Section idea582dfd98ff4dee9ebbe967d9002d81: 506C–2. Extended expiration dates for life-saving drugs A manufacturer of a life-saving drug shall— submit to the Secretary data and information as required by...
- Section id4e0bc3423120403a81533342be1609e8: 3. Reporting on increases in demand for a drug Section 506C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c) is amended— in the section heading, by...
- Section id058bd01485fa47fa93bc47b7d568d5c9: 4. Supporting continuous manufacturing to prevent shortages for susceptible drugs Subtitle B of title III of the 21st Century Cures Act is amended by inserting...
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
This bill, To address prescription drug shortages and improve the quality of prescription drugs, and for other purposes., changes federal law or congressional policy affecting health care providers and patients.
Key Policy Areas
Healthcare, Education, Technology
Primary Purpose
This bill, To address prescription drug shortages and improve the quality of prescription drugs, and for other purposes., changes federal law or congressional policy affecting health care providers and patients.
Policy Domains
Whole bill
Identified Gains
- health care providers and patients
Identified Costs
- federal implementing agencies
- health care providers and patients
Sponsors
Legislative Progress
IntroducedMr. Cardin (for himself, Ms. Smith, and Mr. Blumenthal) introduced …
Impact analysis is available but no clear stakeholder effects identified. View clause-level analysis →
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "secretary_of_health_and_human_services"
- → Secretary of Health and Human Services
Key Definitions
Terms defined in this bill
a drug described in section 506C(a).. A manufacturer of a life-saving drug shall— submit to the Secretary data and information as required by subsection (b)(1)
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology