Case Study: Securing NABP Accreditation for a 503A Sterile Pharmacy in the Midwest
Client Profile
A 503A sterile compounding pharmacy preparing CSPs for patient-specific use.
The Challenge
Following an NABP inspection, the pharmacy received a list of critical deficiencies that jeopardized its sterile compounding operations and future accreditation status. The team needed expert guidance to quickly and effectively respond to NABP findings while ensuring compliance with USP <797> and <800>.
Our Solution
Restore Health Consulting performed a rapid, in-depth review of the pharmacy’s existing documentation, quality systems, and compounding practices. Our team:
Identified gaps in SOPs, environmental monitoring, and aseptic technique documentation
Updated and aligned their quality system with NABP standards and current USP chapters
Drafted a structured, compliant response to NABP’s inspection findings
Provided hands-on coaching and support to ensure successful implementation
The Outcome
✔ All NABP deficiencies were addressed within 30 days
✔ A compliant, detailed response was submitted and accepted
✔ The pharmacy earned full NABP accreditation—without the need for reinspection
Client Impact
The facility preserved its sterile compounding services and is now positioned for long-term regulatory success under the NABP program.