Harshbarger, Carter Introduce Legislation to Empower Compounding Pharmacies and Tackle Drug Shortages

Washington, D.C. — Congresswoman Diana Harshbarger (R-TN) and Congressman Buddy Carter (R-GA), the only two pharmacists serving in the U.S. House of Representatives, this week introduced the Drug Shortage Compounding Patient Access Act of 2025 (H.R. 5316). The legislation strengthens patient access to essential medications during times of shortage and reduces dependence on foreign drug suppliers by ensuring compounding pharmacies can continue filling critical gaps in care.

“As a pharmacist, I know the devastating impact drug shortages can have on patients, families, and hospitals. This legislation ensures when conventionally manufactured drugs aren’t available, American compounding pharmacies have clear authorities and flexibilities to step in, guided by a specified FDA process. By modernizing how shortages are addressed, we can protect patients, strengthen our health security, and reduce our dependence on unstable foreign supply chains,” said Congresswoman Diana Harshbarger.

“The United States currently has over 200 drugs in shortage, representing a threat to public health and safety. By allowing compounding pharmacies to address this crisis by compounding drugs in shortage and improving the process by which FDA establishes the drug shortage list, we will strengthen our nation’s health and security without relying on hostile foreign nations for essential medications,” said Congressman Buddy Carter.

The Drug Shortage Compounding Patient Access Act of 2025 codifies long-standing FDA guidance allowing compounding of certain drugs during shortages and builds on emergency measures taken during the COVID-19 pandemic, when compounding pharmacies stepped in to prepare urgently needed treatments for hospitals.

The Federal Food, Drug, and Cosmetic Act provides two different frameworks for drug compounding, often referred to by their respective sections in statute. 503A pharmacies are state-licensed and regulated by their state boards of pharmacy. They generally operate under the regulations for traditional, patient-specific compounding pursuant to a prescription. In contrast, 503B outsourcing facilities are FDA-registered and regulated directly by the FDA. These facilities are permitted to produce larger batches of compounded medications, which can then be supplied to other healthcare settings such as hospitals and clinics.

Key provisions of the legislation include:

• Drug shortage mitigation: Allows state-licensed 503A pharmacies to compound shortage drugs for urgent hospital or clinical use with physician certification, with a 60-day transition period after a drug leaves the FDA shortage list.
• Improved FDA shortage reporting: Requires drug manufacturers to notify FDA of anticipated disruptions and directs FDA to also consider shortage data from hospitals, clinicians, and patients.
• Outsourcing facility compounding: Strengthens 503B outsourcing facilities by mandating annual updates to FDA’s bulk drug substances list, removing outdated labeling restrictions, and providing a 180-day transition period when shortages end.
• Clarifying provisions & labeling: Modernizes the Food, Drug, and Cosmetic Act by removing obsolete language and requiring clear labeling to indicate when a medication has been compounded.

The legislation has already earned the support of multiple groups including the Alliance for Pharmacy Compounding (APC), the trade association representing more than 600 compounding small businesses across the U.S., The American Pharmacists Association (APhA), and the National Community Pharmacists Association.

“Pharmacists and outsourcing facilities are often the safety net when drug shortages threaten patient care. This important legislation introduced by Congresswoman Diana Harshbarger (R-TN) and Congressman Buddy Carter (R-GA) gives compounders the clarity and certainty they need to keep filling those critical gaps. It’s common-sense legislation that ensures patients don’t go without essential medicines simply because of outdated or ambiguous rules. APC is grateful for their leadership in standing up for patient access,” said Scott Brunner, CEO of the Alliance for Pharmacy Compounding.

“APhA’s Compounding Community of over 3,400 compounding pharmacists and professionals is proud to support compounding pharmacist Rep. Diana Harshbarger’s (TN-01) and pharmacist Rep. Buddy Carter’s (GA-01), The Drug Shortage Compounding Patient Access Act of 2025, to help address drug shortages to ensure patients have access to the safe and effective compounded medications they need,” said Michael Hogue, PharmD, Executive Vice President and CEO of the American Pharmacists Association. 

You can view the bill HERE.