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Standards for Pharmacy Compounding of Non-sterile Preparations

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

April

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.