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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 June 1, 2018. 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 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

Sterile (Hazardous)

Operational

Facilities

2017

February

Council approval of the NAPRA Model Standards for Hazardous and Non-Hazardous Sterile Compounding implementation dates.

 

 

 

 

Spring

Member education to introduce NAPRA Model Standards and implementation timelines:

  • Website Educational Tools
  • CPhM site visits

 

 

 

2018

June

 

5.1 Develop and implement a training and assessment program for staff involved in hazardous compounding.

(June 1, 2018 - Required)

 

 

June

 

5.2 Develop and implement documented policies and procedures for hazardous compounding.

(June 1, 2018 - Required)

 

 

 

June

 

6.2, 6.3, and 6.4 Develop and implement protocols and preparation logs for compounded sterile preparations.

(June 1, 2018 - Required)

 

 

 

June

 

6.7, 6.8, 6.9, 6.12 Develop and implement protocols for hazardous medication packaging, storage, transport, waste management, and delivery procedures.

(June 1, 2018 - Required)

 

 

June

 

6.10, 6.11 Develop recall procedures (traceability), and incident/accident management procedures.

(June 1, 2018 - Required)

 

 

 

June

 

7. Develop and implement a quality assurance program for hazardous sterile compounding.

(June 1, 2018 - Required)

 

 

2018

June - December

CPhM Site Audits to assess compliance with operational requirements (5.1, 5.2, 6.1, 6.2, 6.3, 6.4, 6.7, 6.8, 6.9, 6.12, 6.10, 6.11, 7)

 

 

2019

June

 

6.5, 6.6 Educate and validate all staff involved in hazardous compounding (includes conduct of personnel in areas reserved for compounding, handwashing, garbing, aseptic compounding techniques, cleaning and disinfecting, verification, and labelling).  

(June 1, 2019 - Required)

 

 

2019

June – December

CPhM Site audits to assess compliance with staff education and validation, and ALL other operational requirements.

 

 

2021

January 1

 

6.1 Establish documented beyond-use dates and dating methods.

(January 1, 2021 - Required)

 

 

2021

January 1

 

 

5.3 Facilities and Equipment

Compliance with the NAPRA Model Standards for Hazardous Sterile Compounding Standards

(January 1, 2021 - Required)

2021

January – December

CPhM Site Audits to assess compliance with facilities and equipment requirements.

 

Ongoing audits to assess compliance with operational and facility requirements to be combined with CPhM Routine Hospital and Community Pharmacy Inspections.