Drug Shortage Compounding Patient Act of 2025 Being Introduced

Tennessee’s first US district Congresswoman Diana Harshbarger (R-TN) and Georgia Congressman Buddy Carter introduced legislation this week call the Drug Shortage Compounding Patient 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 that compounding pharmacies can continue filling critical gaps in care. The legislation 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.

Currently, the Federal Food, Drug, and Cosmetic Act provides two different frameworks for drug compounding. First there are 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 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 places such as hospitals and clinics. Among the things this legislation does is allow 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.

Reps. Harshbarger and Carter are experts in this area as they are the only two pharmacists serving in the US House of Representatives.