APC supports introduction of Drug Shortage Compounding Patient Access Act of 2025

FOR IMMEDIATE RELEASE
September 12, 2025

Contact:
Scott Brunner
Alliance for Pharmacy Compounding
media@a4pc.org             

Washington, D.C. — The Alliance for Pharmacy Compounding (APC) announced its support for H.R. 5316, the Drug Shortage Compounding Patient Access Act of 2025, introduced this week by Congresswoman Diana Harshbarger (R-TN) and Congressman Buddy Carter (R-GA), the only two pharmacists currently serving in the U.S. Congress. H.R. 5316 is also supported by the American Pharmacists Association (APhA) and the National Community Pharmacists Association (NCPA). The bill is intended to strengthen patient access to essential medications during drug shortages.

“For years, compounding pharmacies and outsourcing facilities have stepped in to fill critical gaps in care when manufactured drugs are unavailable,” said APC Chief Executive Officer Scott Brunner. “This legislation provides the clear authority and regulatory certainty they need to continue doing that work, so patients don’t suffer because of outdated or unclear rules.”

The legislation codifies long-standing FDA guidance allowing pharmacies to compound copies of FDA approved drugs in shortage as well as FDA guidance issued during the COVID public health crisis via which compounding pharmacies stepped in to prepare COVID treatment drugs in shortage that were urgently needed by hospitals.

Among the legislation’s key provisions:

• Drug shortage mitigation: Allows state-licensed 503A pharmacies to compound shortage drugs for urgent use in hospitals or clinical settings, with appropriate physician certification and recordkeeping, and provides a 60-day transition period when a drug comes off the FDA shortage list.
• Improved FDA shortage reporting: Requires manufacturers to report anticipated disruptions and surges in demand and directs FDA to also consider shortage data from hospitals, clinicians, and patients in setting its shortage list.
• Outsourcing facility compounding: Strengthens the role of 503B outsourcing facilities by requiring annual updates to FDA’s bulk drug substances list, removing outdated labeling restrictions, and allowing a 180-day transition period when drugs leave the shortage list.
• Clarifying provisions & labeling: Eliminates the now obsolete interstate distribution Memorandum of Understanding (MOU) language from 1997 in the Food, Drug and Cosmetic Act while updating labeling to clearly state when a medication is compounded.

“This legislation is common-sense reform,” Brunner said. “It ensures that when shortages happen — and they will — patients can count on compounding pharmacies and outsourcing facilities to be there with rapid solutions.”

APC is urging members of Congress to co-sponsor the bill and support its swift passage.

APC is grateful to Congresswoman Harshbarger and Congressman Carter for their leadership in introducing this important legislation.

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The Alliance for Pharmacy Compounding is the industry trade association and the voice for pharmacy compounding, representing more than 600 compounding small businesses — including compounding pharmacists and technicians in both 503A and 503B settings — as well as prescribers, educators, researchers, and suppliers. Learn more at compounding.com or a4pc.org.