What to Expect When Being Inspected

Purpose and Philosophy of Inspections

The primary mission of inspections is patient safety. The Board emphasizes that sterile compounding oversight is taken very seriously due to the direct impact on patient outcomes.

Inspections are not solely enforcement-driven; they are grounded in education. The goal is to help pharmacies understand requirements, achieve compliance, and ultimately protect patients. Inspectors aim to partner with pharmacies rather than operate strictly as punitive authorities.

Enforcement of USP Standards (USP <797> and <795>)

USP <797> (sterile compounding) and USP <795> (non-sterile compounding) are described as baseline standards. They represent the minimum expectations for compliance. Pharmacies are encouraged not just to meet these standards but to exceed them through best practices. The emphasis is on building a culture that prioritizes quality and safety beyond regulatory minimums.

Inspectors also stress the importance of understanding the intent behind standards—not simply following them because they are required, but understanding how they protect patients.

Inspection Process: What Inspectors Look For

During inspections, the Pharmacy Boards evaluate:

• Cleanroom setup and environmental controls

• Adherence to USP standards

• Policies and procedures

• Documentation and recordkeeping

• Staff practices and technique

• Training and competency validation

Inspectors observe workflows and assess whether day-to-day practices align with documented policies. The process involves both physical inspection and review of compliance systems.

Common Areas of Non-Compliance

The presentation highlights recurring areas where pharmacies often struggle with compliance.

While specific examples vary, common themes include:

• Gaps in documentation

• Failure to fully meet baseline USP requirements

• Inconsistent adherence to procedures

• Insufficient understanding among staff about why standards exist

These issues often stem from misunderstandings or lack of education rather than intentional non-compliance.

Education, Communication, and Staff Understanding

A significant focus is placed on education as a compliance tool.

Inspectors encourage pharmacy leaders to:

• Explain the “why” behind regulatory requirements

• Train staff to understand the clinical relevance of standards

• Foster internal accountability

Simply stating that something is required by USP, the Board, or the FDA is not enough. Staff must understand how standards directly impact patient safety to ensure consistent adherence.

Collaboration with Regulatory Agencies and FDA

The Board collaborates with other state regulatory agencies and the FDA to:

• Share information

• Identify trends

• Address compounding-related risks

This partnership helps regulators monitor emerging compliance issues and ensure consistency in oversight.

Emerging Trends in Compounding Oversight

Through collaboration and inspection data, regulatory agencies identify evolving risks and trends in sterile and non-sterile compounding.

The emphasis remains proactive: identifying issues early, educating pharmacies, and reinforcing standards before patient harm occurs.