Compounding Pharmacy Setup

Plan, build and open a 503A sterile or non-sterile compounding operation.

✓Feasibility and scope: sterile vs non-sterile, hazardous drugs, volume

✓Cleanroom layout aligned to USP <797>/<800> with an outside certifier

✓Equipment and engineering-control selection lists

✓SOPs, training records and environmental-monitoring plan templates

✓Board inspection readiness checklist

📄 Written scope and timeline

📄 Room and equipment plan

📄 SOP and EM template set

📄 Inspection-readiness checklist

Independent certifier partner · Pending Contractor partners · Pending Professional liability insurance · Pending

How it works

We map your goals, space and license class.

Room layout, equipment list and budget range.

Build oversight; certification by an independent, accredited firm.

SOPs, training and inspection walk-through.

Do you certify rooms you help build?

No. Certification goes to an unaffiliated, accredited certifier.

How long does setup take?

It depends on construction and board timing; we give a range after discovery, not a promise.

Do you guarantee a passing inspection?

No. We prepare you; the board and certifier decide.

Pricing by quote (pending). No guarantees of approval, payment or outcome.