To amend the Federal Food, Drug, and Cosmetic Act to ensure patients have access to certain urgent-use compounded medications, and for other purposes.
Summary
What This Bill Does
The bill requires urgent-use compounding for administration in hospitals or other clinical settings Section 503A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C and requires compounding for shortages for administration in hospitals or other clinical settings Paragraph (2) of section 503A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. It relies on definition changes, compliance mandates, product standards, and reporting requirements. The main policy areas are Healthcare Consumers and Healthcare.
Who Benefits and How
Public beneficiaries or protected communities affected by the clause could face reduced risk.
Who Bears the Burden and How
Federal, state, or local agencies responsible for implementing the clause would take on compliance duties and Patients and health care consumers affected by the bill would take on compliance duties.
Key Provisions
- Requires urgent-use compounding for administration in hospitals or other clinical settings Section 503A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
- Requires compounding for shortages for administration in hospitals or other clinical settings Paragraph (2) of section 503A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
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
The bill requires urgent-use compounding for administration in hospitals or other clinical settings Section 503A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C and requires compounding for shortages for administration in hospitals or other clinical settings Paragraph (2) of section 503A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
Key Policy Areas
Healthcare Consumers, Healthcare
Primary Purpose
The bill requires urgent-use compounding for administration in hospitals or other clinical settings Section 503A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C and requires compounding for shortages for administration in hospitals or other clinical settings Paragraph (2) of section 503A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
Policy Domains
Whole bill
Identified Gains
- Public beneficiaries or protected communities affected by the clause
Identified Costs
- Federal, state, or local agencies responsible for implementing the clause
- Patients and health care consumers affected by the bill
Sponsors
Legislative Progress
IntroducedMr. Griffith (for himself and Mr. Cuellar) 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?
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