Bills · HR 5316
IN COMMITTEE· 119TH CONGRESS
House BillHR 5316Health
Drug Shortage Compounding Patient Access Act of 2025
INTRO SEP 11· LAST ACTION SEP 11
READING
7MIN
COSPONSORS
3
READER REACTIONS0 TOTAL
NO VOTES YET · BE THE FIRST
- Introduced only
LEGISLATIVE PROGRESS
STEP 2 / 8Introduced
In Committee
Reported
Passed House
Passed Senate
Conference
To President
Became Law
WHAT THE BILL DOES
AI-writtenPatients in hospitals or clinical settings would be most directly affected, as they might have more timely access to critical, compounded medications during drug shortages or urgent medical situations. The bill aims to prevent delays in treatment by allowing for pre-emptive compounding of shortage drugs.
Licensed pharmacists and physicians who compound medications would gain the ability to compound limited quantities of shortage drugs for urgent hospital use, but would also be subject to new rules regarding certification, labeling, patient record keeping, and adverse event reporting. Drug manufacturers would face new requirements to report potential drug shortages, specifically including "surges in demand," earlier and more comprehensively to the FDA. Hospitals and other clinical settings would be able to receive compounded drugs for urgent use without individual patient prescriptions upfront for shortage drugs, but would need to provide patient records to the compounding pharmacy/physician.
KEY PROVISIONS
5AI-extractedPROVISION 01
Allows licensed pharmacists or physicians to compound limited quantities of shortage drugs for urgent hospital or clinical use without an individual patient prescription at the time of compounding.
This aims to increase immediate access to critical medications during shortages by enabling pre-emptive preparation for urgent needs.
PROVISION 02
Requires the prescribing doctor to certify that they attempted to obtain an equivalent drug from a specialized compounding facility (an "outsourcing facility") but couldn't, before a local pharmacy or physician can compound it for urgent use.
This ensures that compounding by local pharmacies is considered a necessary step when larger, more regulated facilities cannot provide the drug.
PROVISION 03
Mandates strict labeling, patient record linking, and adverse event reporting to the FDA for all urgently compounded shortage drugs.
These measures are crucial for patient safety and tracking, ensuring accountability and monitoring of these specially prepared medications.
PROVISION 04
Requires drug manufacturers to report "surges in demand" for a drug to the FDA, in addition to manufacturing discontinuations or interruptions, as soon as practicable.
This provides earlier warning signs of potential drug shortages, allowing for more proactive management and response.
PROVISION 05
Broadens the definition of "drug shortage" to include situations where demand or projected demand for a drug within the U.S. exceeds the available supply, taking into account preparation, administration route, dosage form, and information from various stakeholders.
This creates a more comprehensive framework for identifying and addressing the various causes of drug shortages.
SPONSORSHIP
1 + 3
R· Tennessee
YRS IN OFFICE
5
BILLS LED
37
COSPONSOR BREAKDOWNBIPARTISAN · 0%
DEM 0 REP 3 IND 0
ACTION TIMELINE
2 EVENTSSEP 11
Introduced in House
SEP 11
Referred to the House Committee on Energy and Commerce.
BILL INFO
TypeHouse Bill
NumberHR 5316
Congress119th
StatusIn Committee
IntroducedSep 11, 2025
Last actionSep 11, 2025
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IN COMMITTEE· 119TH CONGRESS · ENERGY AND COMMERCE COMMITTEE · INTRODUCED SEP 11, 2025
House BillHR 5316Health
Drug Shortage Compounding Patient Access Act of 2025
INTRODUCED SEP 11, 2025· LAST ACTION SEP 11, 2025
PASSAGE CHANCES
—%
READING
7 min
COSPONSORS
3
COMPLEXITY
Moderate
