Sterile compounding

The Standards for Compounding Sterile Non-Hazardous and Hazardous Preparations were created by the National Association of Pharmacy Regulatory Authorities (NAPRA), and approved by the Council of the Alberta College of Pharmacy (ACP) in 2016 and are in effect as of July 1, 2021.

ACP Council determined that in Alberta, only a pharmacy technician or pharmacist may compound sterile preparations. This must not be delegated to a pharmacy assistant or another unregulated individual.

The Model Standards for Compounding Hazardous Sterile Preparations were approved by ACP Council with the following amendments:

• An N95 or N100 NIOSH approved mask is not required when compounding hazardous products in a biological safety cabinet or compounding aseptic containment isolator.
• Pharmacy professionals compounding hazardous products, in compliance with these standards, are not required to wear clean room scrubs.

All pharmacies that perform high-risk sterile compounding will be inspected once every 18 months. All pharmacies that perform sterile compounding other than high risk will be inspected once every three years at minimum. Any re-inspections required will be determined by the pharmacy practice consultant and the sterile compounding assessor.

• NAPRA Model Standards for Pharmacy Compounding of Non-Hazardous Sterile Preparations
• NAPRA Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations

Additional resources

• Sterile compounding licensee self-assessment
• Sterile compounding floorplan preliminary questionnaire