# 119-hr-5316: Drug Shortage Compounding Patient Access Act of 2025

119-hr-5316, Drug Shortage Compounding Patient Access Act of 2025, is a 119th Congress bill sponsored by Rep. Harshbarger, Diana [R-TN-1] (R-TN); status introduced; PRIA reads it as touching household money (as of 2026-07-08).

- Canonical: https://policyrisk.com/legislation/119-hr-5316
- As of: 2026-07-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-hr-5316
- Congress: 119
- Title: Drug Shortage Compounding Patient Access Act of 2025
- Status: introduced
- Introduced: 2025-09-11
- Sponsor: Rep. Harshbarger, Diana [R-TN-1] (R-TN)
- Cosponsors: 3
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-07-08

## Summary

**Would allow urgent-use compounding of shortage drugs by pharmacists and physicians for limited distribution to hospitals and clinical settings.** It would also tighten shortage reporting, labeling, and adverse event tracking to improve patient safety and monitor supply surges. - Hospitals and clinicians: Enables receipt of limited quantities of compounded drugs for urgent administration when a product appeared on the drug shortage list during the prior 60-day period. Orders must include a prescriber certification that a manufacturer or outsourcing-produced drug could not be obtained. - Pharmacists and outsourcing facilities: Creates new documentation and labeling duties. Compounded products must carry a beyond-use date, a clear label that they are not FDA approved, and pharmacists must link patient records within 7 days and report adverse events to FDA MedWatch within 15 days of awareness. - Supply chain and regulators: Expands reporting to cover discontinuances, interruptions, and surges in demand, requires at least 6 months' notice of planned stoppages when possible, and calls for annual public updates on bulk drug substance evaluations used by outsourcing facilities.

## Cosponsors (3)

- Rep. Carter, Earl L. "Buddy" [R-GA-1] (R-GA), 2025-09-11T00:00:00.000Z
- Rep. Owens, Burgess [R-UT-4] (R-UT), 2025-09-17T00:00:00.000Z
- Rep. Harris, Andy [R-MD-1] (R-MD), 2025-10-24T00:00:00.000Z

## Provisions PRIA read

- Earlier alerts on drug demand surges: benefit, medium. Drug makers and outsourcing facilities would need to alert FDA about big demand surges as soon as practicable. They would give at least 6 months’ notice for planned stoppages or interruptions, or report as soon as possible if 6 months is not feasible. The bill updates what “drug shortage” means and…
- Hospitals could get urgent compounded drugs: benefit, medium. If enacted, hospitals and clinics could receive small amounts of compounded drugs for urgent care during shortages. The drug must have been on FDA’s shortage list within the past 60 days, and the prescriber must certify they tried and could not get an outsourcing‑facility version. The compounder wo…
- Clear labels on compounded drugs: benefit, low. Certain compounded prescriptions would need a clear label: “This medication has been compounded for dispensing to an individual patient and has not been approved by the Food and Drug Administration.” The bill also updates a reference so pharmacies use the National Formulary drug or dietary suppleme…
- Wider 180-day window for compounding list: mixed, low. For outsourcing‑facility compounding, a drug would count as shortage‑listed if it appeared at any time in the 180 days before the action. The Health Secretary would also publish yearly updates on how bulk drug substances are evaluated for the outsourcing list.

## Related bills

- 119-hr-4317: PBM Reform Act of 2025
- 119-hr-21: Born-Alive Abortion Survivors Protection Act
- 119-hr-1181: Protecting Privacy in Purchases Act
- 119-hr-987: Fair Access to Banking Act
- 119-hr-5509: Safe Step Act
- 119-hr-404: Hearing Protection Act

## Sources
- [119-hr-5316 on Congress.gov](https://www.congress.gov/bill/119th-congress/house-bill/5316)

## Related
- [119-hr-4317: PBM Reform Act of 2025](https://policyrisk.com/legislation/119-hr-4317)
- [119-hr-21: Born-Alive Abortion Survivors Protection Act](https://policyrisk.com/legislation/119-hr-21)
- [119-hr-1181: Protecting Privacy in Purchases Act](https://policyrisk.com/legislation/119-hr-1181)
- [119-hr-987: Fair Access to Banking Act](https://policyrisk.com/legislation/119-hr-987)
- [119-hr-5509: Safe Step Act](https://policyrisk.com/legislation/119-hr-5509)
- [119-hr-404: Hearing Protection Act](https://policyrisk.com/legislation/119-hr-404)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-hr-5316 (as of 2026-07-08).