Frequently Asked Questions

NAPRA published the Professional Competencies for Pharmacists and Pharmacy Technicians at Entry to Practice in Canada in 2024 following a robust process involving extensive engagement and consultation. This document outlines the professional competencies required for pharmacy professionals at entry to practice (ETP) in Canada, including those required for compounding. The document outlines the following ETP expectations for compounding competence: 

• All pharmacy professionals must be competent to perform non-sterile, non-hazardous compounding at the time of entering practice. 
• All pharmacy professionals must have foundational knowledge of sterile and hazardous compounding principles, procedures, and risks at the time of entering practice.
• All pharmacy professionals must be competent in aseptic technique for medication administration at the time of entering practice.
• The document now clearly reflects that hands-on practical skills are only required for those choosing to work in sterile and/or hazardous compounding.

Since 2014, NAPRA and the pharmacy regulatory authorities (PRAs) engaged in various projects to strengthen the regulatory framework around compounding following safety-related compounding incidents. This led to updated compounding standards of practice in each jurisdiction, as well as a document outlining the detailed competencies necessary for non-sterile, sterile, and/or hazardous compounding. The 2024 ETP competencies document now reflects the existing expectations outlined in those documents, given the additional required training and assessments for sterile and/or hazardous compounding.

• The 2024 ETP competencies document was developed following a robust, multi-year process involving research, environmental scans, and extensive engagement and consultations. This included an interested party survey, an open public consultation, a multi-sector meeting, and individual sessions with interested parties. 
• After much deliberation and assessment of the current state, along with the feedback received, the PRAs collectively decided to revise the 2024 ETP competencies document to ensure the document accurately reflected the existing compounding standards and competencies and was not misleading about entry-level competence, to support patient safety and the public interest. 
• Feedback continues to inform PRA work on next steps to clarify and strengthen the approach to assuring compounding competence in their jurisdictions in a manner that is intended to minimize potential barriers for pharmacy professionals wishing to work in sterile and/or hazardous compounding.

• Entry-to-practice education alone may not provide sufficient assurance of competence to safely perform sterile and/or hazardous compounding for all graduates. Sterile and hazardous compounding are complex, higher-risk areas of practice that require demonstration of competence closer to the point of practice through current, practice-relevant training and/or assessments.
•  The 2024 document requires foundational knowledge for all, while treating sterile and hazardous compounding as complex, specialty areas requiring additional, specific, and ongoing hands-on practical training, and assessment closer to the time of practice, for those that will perform the work. 
• Pharmacy professionals that will never work in sterile and/or hazardous compounding will not need to demonstrate these additional, practical hands-on skills since the skills will not be used and are not required for safe practice unless working in sterile and/or hazardous compounding. If a pharmacy professional later decides to work in sterile and/or hazardous compounding, they will need to obtain the necessary competencies and demonstrate their competence through official, timely assessments prior to working in such settings and on an ongoing basis.

• Patient safety and public protection remain the central focus of the PRAs’ collective work through NAPRA. The approach to compounding competence outlined in compounding standards of practice, compounding competencies, and the 2024 ETP competencies is designed to strengthen patient safety and protect the public interest. Sterile and hazardous compounding are complex, higher-risk areas of practice. This approach to compounding competence reflects the view that competence in high-risk activities should be demonstrated closer to the point of practice through current, practice-relevant training and/or assessments. 
• The 2024 ETP competencies ensure that the competencies are not misleading about entry level competence and that all pharmacy professionals have foundational knowledge, while treating sterile and hazardous compounding as complex, specialty areas requiring additional, specific, timely, and ongoing training and/or assessment beyond baseline ETP requirements. 
• Accreditors and providers of ETP educational programs play an important role in ensuring that all pharmacy professionals have the foundational knowledge of principles, procedures, and risks. However, given the increased risks of these practice areas, there is a need for additional training and assessment of competence in sterile and/or hazardous compounding closer to the point of practice.  
• In other words, this approach provides greater assurance that individuals performing this work are competent when they do so. 

• No. Hands-on practical skills for sterile and hazardous compounding are still expected for those who will practise in those areas. Competence will be supported by additional training and confirmed through assessment close to the time of practice.

• No. Foundational knowledge of sterile and hazardous compounding principles, procedures, and risks remains part of ETP education and expectations, along with competence in aseptic technique. 
• Hands-on practical skills for sterile and hazardous compounding are expected for those who will practise in those areas, supported by additional training, and assessment closer to the time of practice.

• Assessments: Since initial and ongoing competency assessments are already required through the existing compounding standards of practice and compounding competencies, there is expected to be minimal impact from mirroring those requirements in the 2024 ETP competencies document.  
• Education/training: Practice sites will not be solely responsible for education and training. While facility-specific training will continue, the intention is that supplemental, accredited education/training opportunities will be available outside of employers/practice sites, similar to the model for other advanced skills (e.g., injection training).

• NAPRA and the PRAs recognize the importance of maintaining workforce continuity and patient access. The PRAs will continue to work on implementation plans for their jurisdictions that are intended to minimize potential barriers for pharmacy professionals wishing to work in sterile and/or hazardous compounding.
• For example, the PRAs are expected to communicate transition plans for those already practising in sterile and/or hazardous compounding. It is also expected that students will be able to complete supplemental training at the same time as their ETP training if desired and that compounding personnel assessments will be able to be completed within the facility, by Compounding Supervisors or their delegates that meet the National List of Qualifications for Compounding Assessors.

The provincial and territorial PRAs will determine and communicate the specific compounding competence requirements, timelines, and transition approaches in their own jurisdictions. 

• The PRAs are working on clarifying and strengthening the approach to compounding competence in their jurisdictions, while aligning with compounding standards of practice, compounding competencies, and 2024 ETP competencies. 
• Each PRA will have a process for ensuring that individuals seeking to practise in sterile and/or hazardous compounding obtain and retain the competencies beyond entry to practice required to compound sterile and/or hazardous preparations. This will include:
  • Requiring successful completion of initial and ongoing competency assessments by:
    • a Compounding Supervisor, or their delegate, that meets the National List of Qualifications for Compounding Assessors,
    • a third-party assessor that meets the National List of Qualifications for Compounding Assessors, or
    • a PRA-approved assessor.
  • Requiring or recommending the completion of accredited education/training as required to obtain the necessary compounding competencies.

• The PRAs determined that the most appropriate way to ensure that individuals obtain and retain the competencies beyond ETP that are required to compound sterile and/or hazardous preparations is by requiring the successful completion of regular competency assessments in practice.
• Compounding Supervisors are the most appropriate individuals to assess their staff, as they are familiar with the environment, equipment, policies, and procedures at the particular facility. 
• Additionally, this approach presents the fewest barriers to completion of the competency assessments to minimize any potential impact on compounding access.
  • It allows personnel competency assessments to be completed internally, by Compounding Supervisors, or their delegates, that meet the National List of Qualifications for Compounding Assessors.
  • Since initial and ongoing competency assessments are already required for sterile compounding, this approach should not introduce significant additional burden. 
• Compounding Supervisors have significant additional responsibilities and accountabilities. Therefore, it is critical that Compounding Supervisor assessments be completed by a third-party assessor who is free of conflict of interest with the Compounding Supervisor under assessment and the facility.

• Each PRA will determine and confirm the approach to compounding competence in its own jurisdiction.
• Once the details are finalized, PRAs will clearly communicate the jurisdiction-specific timelines and requirements for compounding competence:
  • for those seeking to work in sterile/hazardous compounding for the first time.
  • for those already practising in the area, including any transition plans (“grandfathering”).

• Each PRA will communicate jurisdiction-specific details about transition plans for those already practising in sterile and/or hazardous compounding.
• It is anticipated that there will be options for those already practising, including possible grandfathering approaches, and that not everyone will be required to re-engage in accredited education or training.

• NAPRA facilitates collaboration and national approaches among its Members as they address common issues in the practice of pharmacy in Canada.
• NAPRA is not itself a regulator and does not have authority over pharmacies, pharmacy professionals, or the PRAs. Its role is to support the PRAs, when requested, with next steps on compounding competence.

• NAPRA will support the PRAs with next steps on compounding competence, by helping communicate national-level information:
  • The Guidance for Education Accreditors will support the PRAs by communicating their expectations for education accreditors (including in-person requirements), to improve the consistency and quality of available, accredited, supplemental education programs in sterile and/or hazardous compounding.  
  • The National List of Qualifications for Compounding Assessors will support the PRAs by communicating their expectations for compounding assessors, to ensure that only those with the required qualifications will be assessing compounding competence. 
• NAPRA will also continue to provide updates to interested parties as they become available or are requested by the PRAs.