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Pharmacy Shortage SolutionsPSS

Our Approach

A mobile cleanroom built to 503B standards

What is a 503B outsourcing facility?

Section 503B of the Federal Food, Drug, and Cosmetic Act lets a compounder voluntarily register with the FDA as an “outsourcing facility.” Outsourcing facilities may compound sterile drugs with or without patient-specific prescriptions, generally to supply hospitals and clinics.

In exchange, they must follow current good manufacturing practice (cGMP) requirements, are subject to FDA inspection, and must report the products they compound. Registration does not mean the FDA has approved the compounded drugs themselves.

Walk through the concept

Illustrative cutaway of a mobile cleanroom trailerConcept rendering

Zone 3 of 6

ISO 7 buffer room + ISO 5 hood

The core: an ISO 7 room surrounding an ISO 5 primary engineering control where critical aseptic work takes place.

Design elements

Cleanroom

53-foot mobile ISO 7 cleanroom

A trailer-based controlled environment qualified to ISO 7 classification.
Aseptic

ISO 5 critical aseptic protection

Primary engineering controls for critical aseptic operations.
Quality

cGMP readiness

Quality systems, documentation, environmental monitoring, and training aligned to cGMP.
Oversight

Missouri pharmacist supervision

Compounding operations supervised by a licensed Missouri pharmacist.

Regulatory pathway

  1. Facility design, construction, and qualification
  2. Missouri state licensure
  3. FDA outsourcing facility registration
  4. Ongoing inspections and compliance obligations