24 Supervision Framework of Pharmacy Compounding Personnel in Canada

In Canada, the supervision of pharmacy compounding personnel is governed by national standards developed by the National Association of Pharmacy Regulatory Authorities (NAPRA) and enforced by provincial regulatory bodies. The standards outline the roles, responsibilities, and required competencies for supervisors and compounding staff.  This chapter clarifying the roles and responsibilities of each team member involved in compounding, and explaining how supervision levels—direct versus general—are determined by risk level, staff competence, and task complexity.

Personnel Framework in Non-Sterile Compounding

1. Designated Compounding Supervisor (DCS)

• Each pharmacy engaged in non-sterile compounding must designate a Non-Sterile Compounding Supervisor. This individual is responsible for the daily oversight of compounding activities, ensuring that all preparations are compounded safely, effectively, and in compliance with NAPRA standards.. The supervisor must be either a licensed pharmacist or a registered pharmacy technician with appropriate training and experience.

Key Responsibilities

The responsibilities of the Non-Sterile Compounding Supervisor are broad and integral to the quality assurance framework. Their duties include, but are not limited to:

• • Personnel Training and Competency
    • Ensures that all compounding personnel have received appropriate training and are assessed for competency before engaging in compounding activities. Regular re-evaluations must be documented.
  • Development and Maintenance of Policies and Procedures
    • Establishes, updates, and enforces Standard Operating Procedures (SOPs) for all aspects of non-sterile compounding, including preparation, cleaning, documentation, and incident response.
  • Risk Assessment of Preparations
    • Conducts or oversees risk assessments for all non-sterile compounded preparations. The risk level (A, B, or C) must be determined using NAPRA’s decision-making framework and documented accordingly.
  • Master Formulation Records
    • Ensures that a Master Formulation Record (MFR) is created, validated, and maintained for each compounded preparation. These records must contain complete formulation details, procedures, and quality control checks.
  • Use of Personal Protective Equipment (PPE)
    • Verifies that appropriate PPE is provided, accessible, and used correctly by all compounding personnel. PPE must be suitable for the level of risk and type of preparation involved, ensuring both personnel safety and product quality.
  • Facility Standards Compliance
    • Ensures that the physical environment and equipment used for compounding meet NAPRA’s facility and engineering control requirements, based on the risk level of the preparation.
  • Beyond-Use Dating (BUD)
    • Confirms that appropriate BUDs are assigned to compounded products based on stability data, risk classification, and storage conditions, and that documentation supports these determinations.

2. Pharmacy Manager Responsibilities

• Ensures the pharmacy complies with all NAPRA standards and regulatory requirements.
• Ensures sufficient human and material resources are available.
• May delegate specific responsibilities to the DCS (designated compounding supervisor) but retains overall accountability.

3. Pharmacists

• Conduct clinical assessments to determine if compounding is appropriate.
• Evaluate patient-specific needs, allergies, interactions, and therapy goals.
• Determine the appropriate formulation and verify the final compounded preparation.
• Provide counseling and ensure the patient receives proper instructions for use.

4. Pharmacy Technicians

• Perform compounding tasks within their scope of practice, under pharmacist supervision.
• Are responsible for:
  • Accurate calculations and preparation.
  • Equipment calibration and cleanliness.
  • Documentation of compounding activities.
• Must be assessed for competency prior to participating in compounding activities.

5. Pharmacy Assistants (Support Personnel)

• May perform designated tasks (e.g., weighing, measuring, labeling, cleaning) under supervision.
• Must follow all safety and SOP guidelines.
• Are not authorized to make independent decisions or perform final checks.

Supervision of Compounding Activities

1. Supervision Requirements

• All compounding activities must occur under the supervision of a pharmacist.
• The level of supervision required depends on:
  • The risk level of the compound (Level A, B, or C).
  • The training and demonstrated competency of the personnel.
  • The complexity of the compounding process.

2. Types of Supervision

• Direct Supervision: The supervising pharmacist is physically present in the compounding area and actively monitors preparation. This level is required for high-risk (Level C) compounds or when staff are still in training.

• General Supervision: The supervising pharmacist is on-site and readily accessible, but not necessarily in the compounding area. They conduct routine checks and are available to address issues as needed. This applies to low- and some medium-risk preparations when performed by competent personnel.

Key Roles in Compounding Supervision

In Canada, supervision of pharmacy compounding personnel is a structured process led by a pharmacist or pharmacy technician designated as the compounding supervisor, operating under the oversight of the pharmacy manager. Effective supervision is foundational to safe and compliant non-sterile compounding. The level and type of supervision must reflect the risk of the preparation, the competency of personnel, and regulatory expectations. Supervisors are not only responsible for task oversight, but also for cultivating a culture of quality assurance, safety, and continuous improvement. Understanding and assessing supervision practices enables pharmacy professionals to uphold high standards and ensure patient safety in all compounding activities.