To amend the Federal Food, Drug, and Cosmetic Act to expand drug shortage notification practices to include surges in demand for a drug, 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 amend the Federal Food, Drug, and Cosmetic Act to expand drug shortage notification practices to include surges in demand for a drug, and for other purposes., changes federal law or congressional policy affecting health care providers and patients. The main policy domain is Healthcare, Environment, Agriculture.
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 S1: 1. Short title This Act may be cited as the End Drug Shortages Act.
- Section id37c0096721c54975ad01067b6cd96d91: 2. Drug shortage notification practices Section 506C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c) is amended— in the section heading, by...
- Section id52b25a7e44384a7ba59c1d271748b9e2: 3. Outsourcing facility compounding Section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353b) is amended— by redesignating the 2 subsections...
- Section H95B8FD982CB04312AFD21D142873B007: 4. Hospital and health system compounding Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall...
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 amend the Federal Food, Drug, and Cosmetic Act to expand drug shortage notification practices to include surges in demand for a drug, and for other purposes., changes federal law or congressional policy affecting health care providers and patients.
Key Policy Areas
Healthcare, Environment, Agriculture
Primary Purpose
This bill, To amend the Federal Food, Drug, and Cosmetic Act to expand drug shortage notification practices to include surges in demand for a drug, 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
Tim Kaine
D-VA | Primary Sponsor
Legislative Progress
IntroducedMr. Kaine (for himself and Mr. Cotton) introduced the following …
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 period of time with the demand or projected demand for the drug within the United States exceeds the supply of the drug, taking into consideration— how the drug is prepared or dispensed, including the route of administration and dosage form
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