Attention Sterile Compounding Supervisors!

Competency Assessment

Are you the sterile compounding supervisor for your pharmacy?  If so, NAPRA requires that your compounding competency is assessed by a third-party evaluator.  The frequency of the assessment is as follows:

• at least once a year in the workplace for preparations with low or medium risk level;
• at least twice a year in the workplace for preparations with high risk level.

Qualifications

• The sterile compounding supervisor must have successfully completed training (i.e., courses) in the compounding of sterile preparations, maintained up-to-date knowledge and demonstrated the required competencies.
• The sterile compounding supervisor must also have the competency required to manage a safe, high-quality sterile-preparation compounding area.
• The sterile compounding supervisor must be evaluated for knowledge and abilities, at the same frequency as compounding personnel, by a third party (an evaluator with expertise in sterile- preparation compounding, at arm’s length from the facility/pharmacy and free of any real or perceived conflict with the individual being evaluated).

The third-party evaluator (either a pharmacist or pharmacy technician) must meet the following criteria:

• the third party must be a pharmacist or pharmacy technician with expertise in compounding sterile preparations;
• the third party must be at arm’s length from the pharmacy or facility (independence);
• the third party must be free of any real or perceived conflict of interest with the individual beingevaluated;
• the sterile compounding supervisor must ensure that the third-party evaluator is qualified to fulfill the mandate;
• the third-party evaluator must have training that covers the compounding of sterile preparations and certification that his or her competencies in this area are being maintained and developed;
• the third-party evaluator’s annual competency assessment must include the same elements as those of a competency assessment program for compounding personnel

Content of assessment

The assessment must include the following:

• a theoretical test measuring required knowledge of policies and procedures and the aseptic compounding process;
• a practical test in the workplace clean room (including GFS and a media fill test) to evaluate compliance with operating procedures and knowledge of aseptic compounding processes.

For questions regarding in-person or virtual competency assessment, please email Jennifer Mosher at jennifermosher@stateofcontrol.ca.