NAPRA Model Standards for Compounding Non-Hazardous Sterile Preparations

ACP council approved Standards for Compounding Sterile Non-Hazardous Preparations in June 2016.

This is the first of three (3) complementary standards under development for compounding. These have been developed in collaboration with other provincial colleges of pharmacy, through the facilitation of NAPRA. Development of the standards was expedited in response to numerous adverse compounding events impacting individuals and populations in Canada and the US. All are based on internationally recognized USP standards. Non-hazardous preparations do not include ingredients that may pose health hazards to individuals preparing them.

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

The implementation framework is prioritized according to potential risk to patients and considers resources/expenditures required for compliance with the Standards. It ensures that a quality assurance program is prioritized early in the process to confirm that pharmacy facilities, personnel and equipment maintain a contamination-free compounding environment throughout the implementation process. 

Learn more about the phased implementation schedule in the Fall 2016 issue of acpnews.


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