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Prescription Required 503A Pharmacy Yes, individual patient prescription 503B Outsourcing Facility Can compound without individual prescriptions FDA Inspection 503A Pharmacy State board of pharmacy oversight 503B Outsourcing Facility FDA-registered and inspected Batch Testing 503A Pharmacy Per state requirements 503B Outsourcing Facility Required: potency, sterility, endotoxin Scale 503A Pharmacy Individual or small batch 503B Outsourcing Facility Larger batches for healthcare facilities cGMP Compliance 503A Pharmacy State standards 503B Outsourcing Facility Required to follow current Good Manufacturing Practices PeRx works with licensed compounding pharmacies that meet or exceed these standards

2018 Apr 26;10(5): PMID: 29534031