29 Ensuring Personnel Compliance

Maintaining procedural compliance is essential to ensure the safety, quality, and consistency of non-sterile compounded preparations. Adherence to standardized procedures not only protects patients but also supports the professional accountability of compounding personnel. The NAPRA Model Standards emphasize the importance of formal training, routine assessments, clear documentation, and strong supervision to ensure staff consistently meet expectations. By establishing a culture of compliance, pharmacies can minimize errors, enhance workflow efficiency, and align with regulatory standards. This chapter outlines the key strategies used to monitor and reinforce procedural adherence in the compounding environment.

1. Comprehensive Training and Initial Competency Assessment

• All personnel involved in compounding activities must receive structured training that covers:
  • Compounding techniques.
  • Use of facilities and equipment.
  • Policies and procedures specific to the pharmacy.
  • Health and safety protocols (including PPE use and handling hazardous substances).
• Training should be tailored to the complexity of the compounding (Level A, B, or C).
• An initial competency assessment must be conducted after training. This evaluation may involve:
  • Written or verbal tests.
  • Direct observation of compounding activities.
  • Simulated exercises.

2. Ongoing Competency Assessment and Refresher Training

• Regular skills reassessment must be performed at least every 12 months.
• Reassessment activities can include:
  • Practical demonstrations.
  • Review of documentation practices.
  • Spot audits during actual compounding activities.
• If performance issues are identified, additional targeted training must be provided, and corrective actions must be documented.

3. Clear and Accessible Policies and Procedures

• Policies and procedures for all aspects of compounding must be:
  • Written, detailed, and easy to understand.
  • Readily accessible in the compounding area (e.g., electronic systems, binders).
  • Reviewed every 3 years, or sooner if there are regulatory changes, new evidence, or operational changes.
• Staff must be trained on policy updates promptly.

4. Supervision and Monitoring

• Supervisory roles (e.g., Non-Sterile Compounding Supervisor) are essential for:
  • Observing daily practices.
  • Offering immediate coaching when deviations occur.
  • Performing routine audits (checklists for facility/equipment cleaning, process adherence).
• Supervisors ensure that risk assessments are updated if changes in process or ingredients occur.

5. Documentation of Activities

• All compounding-related activities must be documented, including:
  • Training records.
  • Skills assessments.
  • Daily cleaning logs.
  • Equipment calibration and maintenance logs.
  • Compounding records and any incidents/errors.
• Proper documentation ensures traceability and reinforces accountability among personnel.

6. Responsibility for Ensuring Personnel Compliance

• Ensuring that all compounding personnel follow established procedures is a shared responsibility—but specific roles carry defined accountability under the NAPRA Model Standards and professional regulatory expectations.

Pharmacy Manager / Designated Manager: The pharmacy manager holds overall responsibility for ensuring that the pharmacy operates in compliance with applicable regulations and standards.

• Responsibilities include:
  • Ensuring staff are trained before participating in compounding activities.
  • Approving and maintaining up-to-date policies and procedures.
  • Providing resources (e.g., training time, PPE, documentation tools) to support compliance.
  • Ensuring a designated Non-Sterile Compounding Supervisor is assigned (if not acting in that role themselves).

Non-Sterile Compounding Supervisor (or Equivalent Role): This individual is responsible for day-to-day oversight of compounding activities and acts as the point person for procedural monitoring.

• Responsibilities include:
  • Monitoring adherence to SOPs through direct observation and audits.
  • Conducting initial and ongoing competency assessments.
  • Addressing deviations or deficiencies through feedback and retraining.
  • Updating risk assessments when changes in ingredients, procedures, or equipment occur.
  • Maintaining documentation related to personnel training and incidents.

Compounding Personnel (Pharmacists and Pharmacy Technicians): Each individual involved in compounding is personally responsible for following training and adhering to approved procedures.

• Responsibilities include:
  • Participating in required training and competency assessments.
  • Reviewing and understanding all applicable SOPs.
  • Reporting any errors, near misses, or concerns related to compounding practices.
  • Practicing within their scope of competence and seeking clarification when needed.

Regulatory and Accreditation Bodies: While not directly involved in daily operations, provincial colleges of pharmacy and accreditation organizations set the standards and conduct inspections to verify compliance.

• Responsibilities include:
  • Defining expectations (e.g., NAPRA standards, provincial regulations).
  • Conducting routine inspections and responding to complaints.
  • Requiring corrective action plans where deficiencies are identified.

7. Promoting a Culture of Quality and Safety

• Leadership must foster an environment where:
  • Compliance is seen as critical for patient safety.
  • Staff feel encouraged to report errors, near misses, or procedural challenges without fear of punishment.
  • Continuous quality improvement initiatives are supported (e.g., feedback loops, staff suggestion programs).

Procedural compliance is not a one-time effort.  it requires ongoing attention, active supervision, and a shared commitment to quality and safety. Through structured training, regular assessments, and transparent documentation, pharmacies can ensure that compounding personnel are competent and confident in their roles. Effective supervision and a culture that values continuous improvement further strengthen the reliability of non-sterile compounding practices. By embedding compliance into everyday operations, pharmacy teams can safeguard public health and maintain the highest professional standards.