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503b Outsourcing Facilities

Meaning

503b Outsourcing Facilities are compounding entities that voluntarily register with the FDA under Section 503B of the Federal Food, Drug, and Cosmetic Act, distinguishing them from traditional 503A compounding pharmacies. These facilities are authorized to produce sterile and non-sterile compounded medications in bulk quantities without requiring a prescription for an identified individual patient, serving as a critical component of the institutional drug supply chain. Their function is to provide compounded medications at scale to healthcare systems, ensuring a consistent and reliable supply of preparations that often address specific clinical needs or drug shortages.