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Standards for Pharmacy Compounding of Non-sterile Preparations


The College recently developed "Where do I start? Standards for Pharmacy Compounding of Non-sterile Preparations" for pharmacy professionals in Manitoba.

This guidance document answers frequently asked questions the College has received in preparation for phase one of implementation of the model standards.

The implementation deadline for the implementation of Phase I of the NAPRA Model Standards for Non-sterile compounding has now been postponed until October 1, 2020.


On December 10, 2018, College Council approved an implementation schedule for the NAPRA Standards for Pharmacy Compounding of Non-Sterile Preparations.

Model Standards for Pharmacy Compounding of Non-sterile Preparations
Guidance Document for Pharmacy Compounding of Non-sterile Preparations

Implementation Resources

Implementation Schedule for the Model Standards for Pharmacy Compounding of Non-Sterile Preparations 

Year

Month

Requirements

Phase One

2020

October

Section 4

Section 5.1

Section 6.5

Section 5.2

Section 5.3

Section 5.4

Section 8.1 Level A requirements

Phase Two

2020

October

Section 6.1

Section 6.2

Section 6.3

Section 6.4

Phase Three

2021

January

Section 6.6

Section 6.7

Section 6.8

Section 6.9

Section 6.10

Section 6.11

Section 7

Section 8.2 Level B requirements

Phase Four

2021

April

Section 9

Section 8.3 Level C requirements


Pharmacy Quality Assurance Self-Assessment

To ease the implementation of the NAPRA Model Standards for Pharmacy Compounding of Non-sterile Preparations, the College created a Pharmacy Quality Assurance Self-Assessment tool. 

Please note: The Pharmacy Quality Assurance Self-Assessment is a tool for gap analysis and should not be submitted to the College for approval or review.

On March 25, 2019 Council approved a modified Decision Algorithm for risk assessment from the Model Standards for Pharmacy Compounding of Non-Sterile Preparations Guidance Document. Pharmacies that are engaged in non-sterile compounding should refer to this modified decision algorithm when determining risk categories for the products they compound.