PSM asks House Energy & Commerce Committee to oppose H.R. 5316, The Drug Shortage Compounding Patient Access Act
The Partnership for Safe Medicines sent a letter to the House Energy & Commerce Committee on November 4, 2025 in opposition to H.R. 5316, The Drug Shortage Compounding Patient Access Act because it would undermine critical patient safety protections established by Congress in the wake of tragedies caused by poorly regulated compounded medicine. H.R. 5316 would
- Extend the distribution of unapproved compounded drugs for up to six months after a shortage ends, exposing patients to higher risk even when more tightly regulated FDA-approved alternatives are available,
- Repeal interstate shipment limits and reporting requirements, eliminating restrictions on the volume of compounded drugs that 503A pharmacies can introduce into interstate commerce,
- Enable mass manufacturing under the guise of compounding by allowing 503A compounding pharmacies to produce drugs without patient-specific prescriptions,
- Increase the risk of drug diversion and contamination in the supply chain by removing important labeling requirements for 503B outsourcing facilities, and
- Allow the use of non-pharmaceutical grade ingredients, including in sterile injectable drugs, which poses a direct threat to patient safety.
