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Must register with the FDA as an outsourcing facility Permitted to compound without patient-specific prescriptions (i.e., for office stock) Required to follow cGMP standards Subject to FDA inspections and adverse event reporting Limited to compounding drugs from FDAs 503B bulks list 503B outsourcing facilities are designed for batch compounding at scale, with sterility assurance, standardized quality, and longer beyond-use dates (BUDs) supported by stability data

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represented only a small proportion of the cohort

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