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