Defending a Sterile Compounding Pharmacy Against BUD Enforcement by Board of Pharmacy

Client Type

503A sterile compounding pharmacy under inspection by a State Board of Pharmacy

Engagement Summary

Restore Health Consulting was retained to review and defend the pharmacy’s Beyond-Use Date (BUD) assignment for a sterile compounded preparation, after an inspector flagged a potential stability study failure that could result in regulatory action.

The Challenge

During a routine inspection, a Board of Pharmacy inspector challenged the pharmacy’s extended BUD assignment, alleging that the stability data did not support the assigned shelf life. The inspection report cited what appeared to be a failed result at the midpoint of a critical test parameter—raising the risk of enforcement action, product recalls, or license impact.

The pharmacy needed expert support to:

  • Evaluate the inspector’s claim

  • Verify the integrity of the stability data

  • Draft a defensible response to the Board

  • Resolve the issue without reputational or regulatory damage

Our Solution

Restore Health Consulting conducted a four-part technical and regulatory evaluation:

A. Stability Data & Inspection Report Review

  • Conducted a detailed audit of the stability study design, testing intervals, raw data, and summary reports

  • Cross-checked the inspector’s findings and assumptions with industry standards and regulatory guidance

B. Technical Gap Assessment

  • Identified a procedure deviation and possible misinterpretation of data in a third-party lab’s report

  • Detected a data inconsistency that had been misread as a failure by the inspector

C. Scientific Advocacy

  • Engaged directly with the contract laboratory

  • Presented a technically grounded explanation demonstrating that the midpoint “failure” was in fact a lab error

  • Successfully persuaded the lab to provide a formal statement of the situation and repeat the study at no cost to the client

D. Regulatory Communication Support

  • Drafted a comprehensive, data-driven response to the Board of Pharmacy

  • Positioned the pharmacy as compliant and responsible, and clarified the root cause without blame-shifting

The Result

✔ The third-party lab accepted Restore’s findings and repeated the stability study
✔ The new data supported the original BUD, eliminating the inspector’s concern
✔ The pharmacy avoided enforcement action and maintained confidence in its quality systems
✔ The client was able to continue sterile compounding operations without disruption

“Without Restore’s technical insight and tenacity, we likely would’ve accepted a regulatory loss we didn’t deserve. They caught what no one else could, and saved our operation from a major setback.”

Services Delivered

  • Regulatory Inspection Response Support

  • Stability Study Review & Scientific Interpretation

  • Laboratory Oversight & GLP Advocacy

  • Expert Communication with State Boards

  • Drafting of Formal Regulatory Correspondence

Facing questions from a Board of Pharmacy or Other Agency?

Restore Health Consulting brings deep technical, regulatory, and compounding-specific knowledge to help you respond with clarity—and protect your license, your products, and your patients.