503B Outsourcing Facility (503B)

The FDA has designated 503B compounding pharmacies as those with outsourcing facilities that may manufacture large batches without patient-specific prescriptions to be sold to healthcare facilities, hospitals, office use, etc. These entities are a crucial part of the FDA attempting to limit the effect that drug shortages have on American healthcare.

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Highlights

  • Managed FDA reporting. Conducted on-site audits.
  • Performed retroactive ARCOS reporting for preceding 36 months to obtain quota allotment nuanced by procuring product in one format and selling in a second.
  • Completed 503B-specific state license assessment and ownership change.

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