Strategic Feasibility Assessment for USP <800> Sterile Hazardous Drug Compounding Expansion

Client Type

Pharmacy supporting clinical trial sterile compounding, exploring expansion into hazardous (HD) drug compounding under USP <800>

Engagement Summary

A specialized sterile compounding pharmacy engaged Restore Health Consulting to assess the feasibility, risks, and opportunities associated with expanding its services to include USP <800>–compliant hazardous drug compounding. The client needed a clear, practical roadmap to evaluate whether to move forward with this strategic investment.

The Challenge

The pharmacy was considering a service-line expansion into sterile HD compounding to support more clinical trial sponsors—but lacked clarity on the facility requirements, workflow impact, and regulatory considerations involved. There were concerns about:

  • Space limitations

  • Workflow disruption

  • Licensing implications

  • Return on investment

The client sought objective guidance before making a significant capital and operational commitment.

Our Solution

Restore Health Consulting conducted a full feasibility analysis, including:

  • Facility Walkthrough & Workflow Interviews
    Reviewed existing cleanroom design, workflow, and physical space constraints. Interviewed the PIC and technical staff to understand current operations and limitations.

  • Assessment of USP <800> Requirements
    Identified required upgrades or expansions to meet sterile HD compounding requirements—e.g., negative pressure ISO 7 buffer room, appropriate pass-throughs, BSC placement, and environmental controls.

  • Alternative Solutions
    Determined that expansion within the current facility footprint was not feasible. Proposed four alternative buildout pathways, including adjacent suite expansion and nearby satellite suite options.

  • Strategic Analysis:
    For each pathway, we evaluated:

    • Business opportunity and ROI

    • Licensing impact

    • Cleanroom and HVAC design implications

    • Personnel and training needs

    • Equipment and material requirements

    • Cost and timeline estimates

  • Final Deliverables:
    A detailed report summarizing the expansion options, pros/cons, required milestones, and a decision-making framework for the executive team.

The Result

✔ Client gained a clear understanding of the realistic facility and financial implications of expanding into sterile HD compounding
✔ The analysis enabled them to make a strategic “no-go” decision confidently—avoiding costly rework, downtime, or regulatory missteps
✔ Client retained the report for future use, should business needs shift

“Restore Health gave us the clarity and depth we needed to make the right strategic call. Their report helped us avoid a costly detour, and we’ll absolutely call them when we’re ready to explore future expansion.”

Services Delivered

  • USP <800> Facility Feasibility Assessment

  • Cleanroom Design and Expansion Scenarios

  • Business Case Analysis (Operations, Licensing, ROI)

  • Workflow and Personnel Planning

  • Milestone Roadmapping & Strategic Reporting

Thinking about expanding into USP <800> compounding?

Restore Health Consulting delivers honest, expert-backed assessments that help you grow smart, stay compliant, and invest with confidence.