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503b

Meaning

A 503B Outsourcing Facility is a specialized compounding entity that operates under a different section of the FD&C Act, permitting it to produce sterile and non-sterile compounded drugs in large batches without patient-specific prescriptions. These facilities are designed to meet the needs of hospitals and clinics by providing medications for office use or in anticipation of patient demand. This designation allows for a scaled-up production of standardized hormonal preparations, ensuring greater supply chain efficiency and access to essential medications. Crucially, 503B facilities are registered with the FDA and subject to stricter current Good Manufacturing Practice (cGMP) requirements, similar to conventional drug manufacturers. This enhanced regulatory oversight is intended to ensure a high level of quality and consistency for compounded products distributed broadly.