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Standards for Pharmacy Compounding of Hazardous Sterile Preparations

The Council of the College of Pharmacists of Manitoba (College) approved the implementation schedule for the National Association of Pharmacy Regulatory Authorities (NAPRA) Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations on February 6, 2017. The standards represent a significant change to sterile compounding practice, policies, and physical facility requirements for pharmacies engaged in sterile compounding in Manitoba.

The first implementation deadline for pharmacies engaged in hazardous sterile compounding is January 1, 2019. On this date, pharmacies in Manitoba engaged in sterile compounding are required to complete the operational requirements as outlined in the table below.

Following this initial phase, staff involved in hazardous sterile compounding are required to be educated and validated in accordance with Section 6.5 and 6.6 of the NAPRA Sterile Hazardous Model Standards by June 1, 2019.

Current standards and guidelines for pharmacy compounding of sterile preparations remain in place until the new Model Standards for Pharmacy Compounding come into effect.

The Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations is one part of a suite of model standards for pharmacy compounding. Please see the Standards for Pharmacy Compounding of Non-Hazardous Sterile Preparations page for information on the second part of the suite of model standards for pharmacy compounding. 

Implementation Resources

Pharmacy Quality Assurance Self-Assessment

To ease the implementation of the NAPRA Model Standards for Pharmacy Compounding of Hazardous and Non-Hazardous Sterile Preparations, the College created a Pharmacy Quality Assurance Self-Assessment tool. This Self-Assessment outlines all of the implementation requirements for for the implementation schedule below, including Phases One, Two, and Three.

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.


NIOSH List of Antineoplastic and other Hazardous Drugs in Healthcare Settings, 2016

Implementation Schedule for the Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations

Implementation Schedule for Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations [DOWNLOAD]

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

  1. Quality Assurance

(January 2021 – Required)

 

January

8.2 Level B requirements (if Applicable)

(January 2021 – Required)