H.R. 5316

House

Drug Shortage Compounding Patient Access Act of 2025

Sponsor: Rep. Buddy Carter (R-GA)

Introduced

The bill has been introduced and is awaiting committee action.

In brief

This bill relaxes federal regulations on pharmacy and bulk drug compounding to increase the availability of medications during shortages. It authorizes licensed pharmacists to compound limited quantities of drugs on the Food and Drug Administration (FDA) shortage list for urgent medical needs without a specific patient prescription. The legislation also allows FDA-registered outsourcing facilities to continue compounding shortage drugs for 180 days after they are removed from the official shortage list and requires manufacturers of life-sustaining drugs to report demand surges to the FDA. Introduced by Rep. Diana Harshbarger (R-TN), the bill has been referred to the House Committee on Energy and Commerce.

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