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Section 503b Outsourcing Facilities

Meaning

Section 503b Outsourcing Facilities are specialized compounding facilities registered with the FDA that are permitted to produce large batches of sterile and non-sterile compounded drugs without patient-specific prescriptions, operating under more rigorous Current Good Manufacturing Practice (CGMP) standards. Within the hormonal health and wellness space, these facilities are utilized to manufacture standardized compounded hormone preparations, often for hospital use or clinical practices that require a steady, high-volume supply of a specific formulation. Their primary advantage is the enhanced quality assurance and sterility controls associated with their federal registration, offering a higher degree of consistency than traditional compounding pharmacies. These facilities provide a necessary bridge between traditional pharmacy compounding and full-scale pharmaceutical manufacturing.