HR. 5316In Committee
Drug Shortage Compounding Patient Access Act of 2025
Loosens certain drug compounding rules during FDA shortage periods and expands related reporting and transparency requirements
Plain-English overview
What this bill does
Loosens certain drug compounding rules during FDA shortage periods and expands related reporting and transparency requirements
Key points
- Require annual FDA substance updates
- Require demand surge reports
- Allow shortage based pharmacy compounding
- Extend outsourcing facility compounding period
Current status
Where it stands
Status
In Committee
Latest action
2025-09-11 — Referred to the House Committee on Energy and Commerce.
Related context
Topics and policy areas
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