US Federal 2025-2026 Regular Session

US Federal House Bill HB5316

Introduced
9/11/25  

Caption

Drug Shortage Compounding Patient Access Act of 2025

Companion Bills

No companion bills found.

Previously Filed As

US HB167

Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 This bill relaxes certain requirements for compounding drugs that are facing shortages. Drug compounding is the process of mixing or otherwise altering drugs to create a medication. Currently, the Food and Drug Administration (FDA) allows for drug compounding subject to certain requirements. Generally, a licensed pharmacist or physician not registered with the FDA may only compound drugs in limited quantities for prescriptions for a specific individual patient. On the other hand, an FDA-registered outsourcing facility may compound drugs in bulk for use in medical facilities but is subject to additional requirements. This bill allows a compounder not registered with the FDA to compound drugs in limited quantities for an urgent medical need not involving a specific patient if, among other requirements (1) the prescriber certifies that the prescriber is unable, despite reasonable attempts, to obtain certain related drugs with the same active ingredient and route of administration; (2) the compounded drug meets certain labeling requirements, including an indication that the compounded drug is provided only for urgent administration to a patient; and (3) the compounder requests and maintains certain records about patients receiving the compounded drug. Furthermore, a restriction against an unregistered compounder regularly compounding (or compounding inordinate amounts of) what is essentially a copy of a commercially available drug shall not apply if the drug is on a shortage list maintained by the FDA or the American Society of Hospital Pharmacists.

US SB0282

Compounding drugs; registration of medical spas.

US SB2665

Drug Shortage Prevention Act of 2025

US HB917

Compounding pharmacies; use of bulk drug substances, recordkeeping.

US HB1905

Compounding drugs; exceptions for distribution within hospital or health system.

US SB1366

Compounding drugs; exceptions for distribution within hospital or health system.

US HB6117

Patient Device Data Access Act of 2025

US SB652

Protecting Patients from Deceptive Drug Ads Act

US HB6509

SAFE Drugs Act of 2025 Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2025

US H1407

Compounding Pharmacies

Similar Bills

VA SB1366

Compounding drugs; exceptions for distribution within hospital or health system.

VA HB1905

Compounding drugs; exceptions for distribution within hospital or health system.

CA AB2442

Peptides.

VA HB917

Compounding pharmacies; use of bulk drug substances, recordkeeping.

HI HB2164

Relating To Workers' Compensation.

HI SB2751

Relating To Workers' Compensation.

CO SB066

Regulation of Compounded Weight-Loss Medication

CA AB1990

Pharmacy Law: compounded medications: consumer protection.