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Who We Serve

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Who We Serve

TQIP

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At 503B-outsourcing-One, we specialize in FDA-registered sterile and non-sterile compounding services tailored for hospitals, surgery centers, and clinics nationwide. With four ISO-8 cleanrooms, rapid 24–72 hour turnaround, and private-label capabilities, we deliver high-quality, compliant medications with a relentless commitment to safety, consistency, and reliability — because at 503Boutsourcingone, Top Quality is Priority (TQIP).

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cGMP Compliance at 503Boutsourcingone

At 503B-outsourcing-One, we operate under full compliance with current Good Manufacturing Practices (cGMP) as outlined by the FDA. Our facility’s sterile compounding processes follow the same rigorous standards required of pharmaceutical manufacturers — including validated equipment, controlled environments, documented procedures, and continuous quality oversight. Every batch is compounded, tested, and released according to cGMP protocols, including sterility testing, potency verification, and proper documentation. Our cleanrooms are ISO-8 certified and maintained through validated environmental monitoring and aseptic process controls. Compliance isn’t just a checkbox — it’s how we deliver on our promise that Top Quality is Priority (TQIP).

Hospitals and Health Systems

Outpatient Surgery Centers (ASCs)

Specialty and Primary Care Clinics

Independent and Institutional 

Pharmacies

Group Purchasing Organizations (GPOs)

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