H.R. 5316

House

Drug Shortage Compounding Patient Access Act of 2025

In debate

The bill is being debated or has cleared committee and is moving toward a floor vote.

In brief

This bill allows pharmacists to compound drugs facing shortages without individual patient prescriptions and permits outsourcing facilities to continue bulk compounding for 180 days after a drug is removed from the FDA shortage list. It mandates that manufacturers report sudden surges in demand for life-sustaining medications to the FDA and requires the agency to provide annual updates on its list of approved bulk drug substances. Introduced by Representative Diana Harshbarger (R-TN), the legislation has been referred to the House Committee on Energy and Commerce. These changes affect FDA-registered outsourcing facilities, licensed pharmacists, and patients requiring access to drugs currently in short supply.

Timeline

Every recorded action, oldest first.

June 21, 2026 · House
Introduced
The bill eases regulations on compounded drugs to mitigate the impact of national pharmaceutical shortages on patients.
Next: Referred to the House Committee on Energy and Commerce.
Source
August 16, 2026 · House
Introduced
The Drug Shortage Compounding Patient Access Act of 2025 was the fifth most-viewed bill for the week of August 16, 2026.
Next: Referred to the House Committee on Energy and Commerce.
Source
August 30, 2026 · House
Introduced
Introduced to allow compounding of medications to mitigate the impact of national drug shortages.
Next: Referred to House Committee on Energy and Commerce.
Source
September 27, 2026 · House
Introduced
The Drug Shortage Compounding Patient Access Act of 2025 expands the ability of pharmacies to compound drugs during national shortages.
Next: Referred to House Energy and Commerce Committee.
Source
October 11, 2026 · House
Debated
Allows compounding of drugs that are in short supply to ensure patient access.
Next: Awaits committee markup.
Source
October 11, 2026 · House
Introduced
The Drug Shortage Compounding Patient Access Act of 2025 aims to alleviate medication shortages through compounding.
Next: Referred to the House Committee on Energy and Commerce.
Source
November 1, 2026 · House
Introduced
Permits compounding pharmacies to manufacture drugs that are in short supply to ensure patient access.
Next: Referred to House Energy and Commerce Committee.
Source