NCPA and the Alliance for Pharmacy Compounding sent a letter to members of Congress calling for them to support compounding pharmacies by opposing the SAFE Drug Act (H.R. 6509/S. 3794) and sponsoring the Drug Shortage Compounding Patient Access Act (H.R. 5316).
NCPA and the APC argued that the SAFE Drugs Act, if enacted into law, would impose a strict monthly limit of 20 units per month for 503A pharmacies compounding these medications. Additionally, the SAFE Drugs Act would inhibit 503A pharmacies from compounding drugs in shortage. The bill would also mandate that pharmacies shipping more than 20 out-of-state prescriptions monthly report detailed product and volume data to the FDA. This creates a significant administrative burden on small-business pharmacies and could discourage the interstate distribution of specialized drugs to patients in rural or underserved areas.
Instead, NCPA and the APC urged Congress to support H.R. 5316, the Drug Shortage Compounding Patient Access Act to provide a balanced pathway for compounders to respond proactively to shortages while maintaining rigorous safety standards.
