Drug Shortage Compounding Patient Access Act of 2025

Bill Number

H.R. 5316

Origin Chamber

House

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-09-11: Referred to the House Committee on Energy and Commerce.

Last Updated

2026-07-06T20:10:06Z

AI-Generated Summary

Purpose

The Drug Shortage Compounding Patient Access Act of 2025 aims to improve patient access to compounded medications—drugs custom-made by pharmacists or physicians—during drug shortages or surges in demand. It amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow limited compounding and distribution for urgent use in clinical settings, while enhancing reporting on shortages to prevent disruptions in supply.

Key Provisions

• Expanded Compounding Permissions (Section 503A Amendments):
• Allows licensed pharmacists or physicians to compound drugs for urgent administration in hospitals or clinics, even without an initial individual prescription, if the drug was on the FDA's shortage list within the prior 60 days.
• Requires the prescribing doctor to certify they couldn't obtain a similar drug from an outsourcing facility (a specialized compounding operation registered with the FDA).
• Mandates labeling with a "beyond-use date" (expiration based on safety standards), warnings for urgent use only, and requests for patient records within 7 days of administration or discharge.
• Requires linking patient info to orders and reporting adverse events to the FDA's MedWatch program within 15 days.
• Updates the definition of a compounded drug being "essentially a copy" of a commercial one to exclude those made during shortages, provided documentation and labeling rules are followed.

• Improved Shortage Reporting (Section 506C Amendments):
• Expands manufacturer reporting requirements to include not just production discontinuations or interruptions, but also surges in demand (sudden increases that could lead to shortfalls).
• Shortens advance notice for surges to "as soon as practicable," while keeping 6 months for planned discontinuations (or sooner if impossible).
• Broadens notifications to include outsourcing facilities and clarifies "drug shortage" to consider demand, supply preparation methods (e.g., dosage form), and reports from professionals and patients.
• Defines "surge" as an unmet increase in demand likely causing delays.

• Outsourcing Facility Rules (Section 503B Amendments):
• Extends the shortage look-back period for using bulk substances from the current time to any point in the prior 180 days.
• Removes certain reporting subclauses and adds a requirement for the FDA to annually update its public list of evaluated bulk drug substances (raw ingredients) for compounding.

• Labeling and Clarifications (Section 503A Amendments):
• Standardizes labels on compounded drugs to state they are custom-made for individual patients and not FDA-approved.
• Expands references to include dietary supplement monographs (detailed standards) from the National Formulary.

Significant Changes to Existing Law

• From Individual-Prescription Focus: Previously, compounding under Section 503A required a patient-specific prescription upfront. The bill allows initial distribution to prescribers for urgent hospital/clinic use during shortages, with follow-up patient linking—shifting from strict per-patient rules to flexible urgent access.
• Shortage Reporting Expansion: Adds "surge in demand" to Section 506C, which previously focused only on supply-side issues like manufacturing halts. This includes demand-side triggers and adjusts timelines for faster alerts.
• Shortage Window for Outsourcing: Changes Section 503B from checking shortages "at the time of" compounding to a 180-day prior period, giving more leeway for bulk substance use.
• Exclusions from "Copy" Restrictions: Refines Section 503A(b) to permit compounding drugs similar to commercial ones if shortages exist and conditions are met, reducing barriers during crises.
• Annual FDA Updates: Introduces mandatory public updates to the bulk drug substance list, improving transparency over ad-hoc evaluations.

Potential Impacts

• On Citizens/Patients: Increases access to essential medications during shortages, potentially reducing treatment delays in emergencies (e.g., hospitals facing urgent needs). However, it emphasizes safety through reporting, which could help prevent risks from unapproved compounded drugs.
• On Government Agencies: The FDA gains more adverse event reports and must update lists annually, increasing workload for monitoring but aiding better shortage predictions. No direct international relations impacts noted, though global supply chains could indirectly benefit from U.S. stability.
• On Healthcare Providers: Pharmacists, physicians, and hospitals face new documentation and reporting duties but gain flexibility for urgent compounding, possibly easing operations during crises.

Main Stakeholders Affected

• Patients: Primary beneficiaries through faster access to shortage drugs in clinical settings.
• Healthcare Professionals: Licensed pharmacists, physicians, and prescribers must comply with certifications, labeling, and reporting.
• Facilities: Hospitals, clinics, and outsourcing facilities (FDA-registered compounders) involved in distribution and record-keeping.
• Drug Manufacturers: Required to report surges/disruptions earlier, potentially facing more scrutiny on supply planning.
• FDA: Oversees expanded compounding, shortage lists, and MedWatch reporting, with added transparency obligations.

Notable Legal, Constitutional, or Political Implications

• Legal: Strengthens FDA oversight by mandating adverse event reporting and patient tracing, balancing access with public health protections under the FD&C Act. It avoids overriding FDA approval processes but creates exceptions for shortages, which could lead to litigation if safety issues arise from compounded drugs.
• Constitutional: No direct challenges noted; aligns with Congress's authority to regulate interstate commerce and public health, promoting welfare without infringing on states' pharmacy licensing.
• Political: Addresses ongoing drug shortage concerns (e.g., post-COVID supply issues), potentially bipartisan appeal for patient safety. Could influence future pharma policy by prioritizing urgent needs over rigid compounding bans, though critics might argue it risks unsafe practices without full FDA review.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Harshbarger, Diana [R-TN-1]

Cosponsors (3)

Rep. Carter, Earl L. "Buddy" [R-GA-1], Rep. Owens, Burgess [R-UT-4], Rep. Harris, Andy [R-MD-1]

Recent Actions

• 2025-09-11: Referred to the House Committee on Energy and Commerce.
• 2025-09-11: Introduced in House
• 2025-09-11: Introduced in House

Bill Versions

• Drug Shortage Compounding Patient Access Act of 2025 — issued 2025-09-11 — PDF (10 pages)