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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

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.


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

Year

Month

General  Consideration

Requirements

PHASE ONE

2020

April

 

4. Risk assessment must be completed for each compounded non-sterile product to be compounded at the facility.

(April 1, 2020 – Required)

 

April

 

5.1 Compounding personnel must be knowledgeable and perform their roles and responsibilities in accordance with the NAPRA standards.

(April 1, 2020 – Required)

 

April

 

6.5  Conduct of Personnel in compounding areas

(April 1, 2020 – Required)

 

April

 

5.2 Training and Skills Assessment.  Compounding personnel must receive proper training and skills assessment in accordance with the type of compounding to be done.

(April 1, 2020 – Required)

 

April

 

5.3 Policies and Procedures – policies and procedures must be developed and implemented for non-sterile compounding.

(April 1, 2020 – Required)

 

April

 

5.4 Facilities and Equipment

Compliance with the NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations in accordance with the risk level being compounded

(April 1, 2020 – Required)

 

April

8.1 Level A requirements

Compliance with Level A requirements.

(April 1, 2020 – Required)

PHASE TWO

2020

October

 

6.1 Beyond Use Dating

Establish documented beyond use dates and dating methods.

(October 2020 – Required)

 

October

6.2 Master Formulation Record

(October 2020 – Required)

 

October

6.3 Quality and Storage of Ingredients

(October 2020 – Required)

 

October

6.4 Compounding Record

(October 2020 – Required)

PHASE THREE

2021

January 

 

6.6 Verification of final compounded non-sterile preparations

(January 2021 – Required)

January 

 

6.7 Labelling and packaging

(January 2021 – Required)

 

January

6.8 Storage

(January 2021 – Required)

 

January

6.9 Transport and Delivery

(January 2021 – Required)

 

January

6.10 Product Recalls

(January 2021 – Required)

 

January

6.11 Incident and Accident Management

(January 2021 – Required)

 

January

7. Quality Assurance

(January 2021 – Required)

 

January

8.2 Level B requirements (if Applicable)

(January 2021 – Required)

PHASE FOUR

 2021

April

9 Hazardous Preparations (if applicable to the pharmacy)

Compliance with NAPRA standards regarding facilities, equipment, cleaning, incident and accident management, hazardous waste management and verification of secondary and primary engineering controls.

(April 1, 2021 – Required)

 

April

8.3 Level C requirements (if applicable)

(April 1, 2021 – Required)