33 Chapter 33: Non Compliance

In pharmacy compounding, maintaining strict compliance with the Quality Assurance (QA) Program is critical to ensure patient safety, the integrity of compounded preparations, and regulatory compliance. According to the NAPRA Standards and Guidance Document, when potential non-compliance or errors are detected during any stage of compounding or facility operations, immediate action is required to minimize risks.

Key Expectations for Recognizing and Acting on Potential Non-Compliance:

• Immediate Recognition:
  All compounding personnel must be trained to recognize any deviation from established QA procedures, policies, or compounding standards. Examples of potential non-compliance include:
  • Deviations in documented procedures (SOPs)
  • Equipment malfunction or improper maintenance
  • Environmental control failures (e.g., air quality issues)
  • Incorrect ingredient measurements
  • Expired materials being used
  • Incomplete documentation
  • Missing quality control checks (e.g., final weight checks, pH testing)

• First Action — Pause the Process:
  If a deviation or non-compliance is identified during compounding or QA verification:
  • Stop the compounding process immediately if the integrity or safety of the preparation could be compromised.
  • Quarantine affected materials or preparations to prevent dispensing.

• Notify the Compounding Supervisor Immediately:
  • Inform the compounding supervisor (usually a pharmacist or pharmacy technician designated as the Non-Sterile Compounding Supervisor) as soon as a potential issue is identified.
  • Provide a clear description of the observed deviation and any actions already taken (e.g., stopping production, isolating the batch).

• Document the Incident:
  • An initial incident report must be completed as soon as possible, detailing:
    • What happened
    • When and where it was detected
    • Who identified the issue
    • Immediate actions taken
  • This report forms the basis for the pharmacy’s incident review and quality improvement efforts.

• Supervisor’s Role:
  Upon notification, the compounding supervisor is responsible for:
  • Investigating the deviation
  • Determining the scope and potential impact
  • Implementing corrective and preventive actions (CAPA)
  • Updating policies or retraining staff if needed
  • Ensuring any compromised preparations are appropriately disposed of or corrected, if possible.

• Corrective Actions and Preventive Actions (CAPA):
  The pharmacy must use a structured CAPA process to:
  • Correct the immediate problem
  • Analyze root causes
  • Prevent recurrence through training, policy updates, or procedural adjustments

• Emphasizing a “Culture of Safety”:
  It is critical that all pharmacy personnel feel responsible for reporting potential non-compliance without fear of blame. Recognizing and responding to non-compliance is considered a professional obligation to protect patients and maintain the quality and safety of compounded preparations.

When potential non-compliance with the QA program is detected, pharmacy personnel must immediately stop the compounding activity, quarantine affected materials, notify the compounding supervisor, document the incident, and cooperate fully in any investigation and corrective action efforts. Early intervention protects patient safety and helps maintain the pharmacy’s compliance with NAPRA standards.

Checklist: Responding to Potential Non-Compliance in Compounding:

Step 1 — Recognize

• Monitor for any deviation from compounding procedures, facility/equipment maintenance, or documentation standards.
• Examples:
  • Incorrect measurement or ingredient
  • Equipment malfunction
  • Missing/incomplete documentation
  • Environmental issues (e.g., ventilation failure)

Step 2 — Immediate Action

• STOP the compounding process immediately if product safety or integrity is at risk.
• Isolate/Quarantine any affected ingredients, equipment, or compounded preparations to prevent use

Step 3 — Notify Supervisor

• Immediately inform the Non-Sterile Compounding Supervisor (pharmacist or pharmacy technician in charge).
• Provide clear, factual information:
  • What was observed
  • When and where it occurred
  • What immediate action you took

Step 4 — Document

• Complete an Incident Report:
  • Description of event
  • Actions taken
  • Staff involved
  • Any suspected causes
• Submit the report according to pharmacy policy.

Step 5 — Assist with Investigation

• Cooperate in the supervisor’s investigation.
• Assist in identifying the root cause if needed.
• Participate in any retraining or process reviews if corrective actions are identified

Step 6 — Learn and Improve

• Review corrective and preventive actions (CAPA) taken.
• Update skills and knowledge to prevent recurrence.
• Support a culture of safety: Report issues without fear of blame — early reporting protects patients.

Quick Reminder

Patient safety is the priority.
Immediate action + full documentation + supervisor notification = professional responsibility.