Adoption of Model Standards for Compounding

The National Association of Pharmacy Regulatory Authorities approved its first set of model standards related to compounding in 2016. Since then, the provincial pharmacy regulators have made key decisions regarding the adoption of the model standards and set deadlines for implementation. The tables below highlight those key decisions and deadlines, including the decision by provinces to adopt the standards "as is" or with amendments. Please note that information will be added regarding the decisions made by the territories as it is known.

Non-Hazardous Sterile Preparation Compounding

Province

Adoption or Amendment of the Model Standard

Date approved

Applicability to hospitals

Deadlines

Notes

Reference

Newfoundland and Labrador

Adopt

Adopted Feb./16

Yes

Phase 1: Dec.31/2019.

Phase 2: Dec.31/2020.

Phase 3: Dec.31/2021.

 

https://bit.ly/30oXC9u

https://bit.ly/2JuSECL

Nova Scotia

Adopt

Adopted Model Standards Apr./16 with an effective date of Jun.30/16.

No

Effective date Jun.30/2016

 

https://bit.ly/2XJNoE8

Prince Edward Island

No

Not applicable

No

Not applicable

No standards or guidelines currently in place for compounding sterile preparations. 

Email correspondence with info@pepharmacists.ca

New Brunswick

Adopt

Mar.27/17

Yes

New coming into force date: May 1/2018.

Gap analysis deadline: Aug.1/2018.

Within 6 months of coming into force date:

Nov.1/2018.

Fully compliant deadline: May 1/2020.

 

https://bit.ly/2LWcXe3

 

https://bit.ly/32nqbpQ

 

Quebec

No

Not applicable

No

Not applicable

OPQ compounding standards are derived from USP standards. NAPRA Model Standards were based on OPQ's compounding standards. 

 

Ontario

Adopt

Adopted Sept./16

Yes

Jan.1/2019: All pharmacies should be fully compliant with all critical elements of the standards.

Pharmacies should have an action plan towards full compliance of the standards if they are not be fully compliant by Jan.1/2019. See link for further details.

https://bit.ly/2W8ZHZD

 

Manitoba

Amend

Implementation schedule for NAPRA Standards for Pharmacy Compounding of Non-hazardous and Hazardous Sterile Preparations approved by the College Council on Feb.6/17.

Yes

Phase 1: Jan.1/2019.

Phase 2: Jun.1/2019.

Phase 3: Jan.1/21.

CPM has passed amendments to the NAPRA Model Standards for Pharmacy Compounding of Sterile Preparations.

https://bit.ly/2G8XTWm

 

https://bit.ly/2XgVfVq

Saskatchewan

Adopt

Adoption of NAPRA compounding standards Dec.15/17

Implementation plans approved Dec./18

No

Phase 1: Sept./2019

Phase 2: Mar./2020

Phase 3: Jul./2020

Phase 4: Dec./2020

 

https://bit.ly/2JBQlMV

 

Alberta

Amend

2016

No

Priority 1: Jul.1/2018.

Priority 2: Jan.1/2019.

Priority 3: Jul.1/2020 for high risk sterile compounding.

Jul.1/2021 for all remaining sterile compounding.

ACP has passed amendments to the Model Standards for Compounding Hazardous Sterile Preparations.

In Alberta, only a CPhT or RPh is permitted to compound sterile preparations.

https://bit.ly/2JHRsgA

 

British Columbia

Adopt

NAPRA sterile compounding guidelines/

implementation timeline approved Apr./17. Approved adopting the NAPRA Standards to be in effect for May 2021.

 

Yes

Phase 1: Nov./2017

Phase 2: May/2019

Phase 3: May/2020

Phase 4: May/2021

 

https://bit.ly/2SbpeMC

 

Hazardous Sterile Preparation Compounding

Province

Adopt or Adapt

Date approved

Applicability to hospitals

Deadlines

Notes

Reference

Newfoundland and Labrador

Adopt

Adopted February 2017

Yes

Phase 1: Dec.31/2019.

Phase 2: Dec.31/2020.

Phase 3: Dec.31/2021.

 

https://bit.ly/2S7Z51b

 

https://bit.ly/2JuSECL

Nova Scotia

Adopt

Model Standards adopted Nov./16 with an effective date of Feb.27/17

No

Effective date: Feb.27/2017

 

https://bit.ly/2XJNoE8

Prince Edward Island

No

Not applicable

No

Not applicable

No standards or guidelines currently in place for compounding sterile preparations. 

Email correspondence with info@pepharmacists.ca

New Brunswick

Adopt

Mar.27/17

Yes

New coming into force date: May 1/2018.

Gap analysis deadline: Aug.1/2018.

Within 6 months of coming into force date: Nov.1/2018.

Fully compliant deadline: May 1/2020.

 

https://bit.ly/2JBQ8JL

 

 https://bit.ly/32rRvTJ

 

Quebec

No

Not applicable

No

unknown

OPQ compounding standards are derived from USP standards. NAPRA Model Standards were based on OPQ's compounding standards. 

 

Ontario

Adopt

Approved Sept./16

Yes

Jan.1/19: All pharmacies should be fully compliant with all critical elements of the standards.

Pharmacies should have an action plan towards full compliance of the standards if they are not be fully compliant by Jan.1/19. See link for further details.

https://bit.ly/2W8ZHZD

 

Manitoba

Amend

Implementation schedule for NAPRA Standards for Pharmacy Compounding of Non-hazardous and Hazardous Sterile Preparations approved by the College Council on Feb.6/17.

Yes

Phase 1: Jan.1/2019

Phase 2: Jun.1 /2019

Phase 3: Jan.1/2021

CPM has passed amendments to the NAPRA Model Standards for Pharmacy Compounding of Sterile Preparations.

https://bit.ly/2G8XTWm

 

https://bit.ly/2XTILGP

Saskatchewan

Adopt

Adoption of NAPRA compounding standards Dec.15/17

Implementation plans approved Dec./18

No

Phase 1: Sept/2019

Phase 2: Mar./2020

Phase 3: Jul./2020

Phase 4: Dec./2020

 

https://bit.ly/30ynekD

 

Alberta

Amend

2016

No

Priority 1: Jul.1/2018.

Priority 2:  Jan.1/2019.

Priority 3: Jul.1/2020 for high risk sterile compounding.

Jul.1/2021 for all remaining sterile compounding.

ACP has passed amendments to the Model Standards for Compounding Hazardous Sterile Preparations.

In Alberta, only a CPhT or RPh is permitted to compound sterile preparations.

https://bit.ly/2JHRsgA

British Columbia

Adopt

NAPRA sterile compounding guidelines/

implementation timeline approved Apr./17. Approved adopting the NAPRA Standards to be in effect for May 2021.

 

Yes

Phase 1: Nov./2017

Phase 2: May/2019

Phase 3: May/2020

Phase 4: May/2021

 

https://bit.ly/2SbpeMC

 

Non-sterile Compounding

Province

Adopt or Adapt

Date approved

Applicability to hospitals

Deadlines

Notes

Reference

Newfoundland and Labrador

Adopt

Adopted in Principle Feb./2018

Yes

Level A compliance: December 31/2020.

Level B or C facility renovations deadline: Dec.31/2021.

Phase 1: Dec.31/2019

Phase 2: Dec.31/2020

Phase 3: Dec.31/2021

 

https://bit.ly/2LMnCaR

 

https://bit.ly/2xJTaWE

 

Nova Scotia

No

Not applicable

No

Not applicable

“The NSCP is in the process of amending the NAPRA Non-Sterile Standards with the intention of ensuring that they are consistent with other NSCP Standards and appropriate for the Nova Scotia context. It is expected that this work will be completed within the next few months.” Jun.4/19

Email correspondence with NSCP.

Prince Edward Island

Adopt

NAPRA non-sterile compounding standards approved for adoption on Nov.28/18.

Guidance document was amended and approved Jan./19.

No

Priority 1: Apr.1/2020

Priority 2: Oct./2020

Priority 3: Apr.1/2021

 

https://bit.ly/2JrXbps

New Brunswick

Adopt

Feb.4/19

Yes

Coming into force: Jul.1/2019

Phase 1 deadline Jan.1/2020

Phase 2 deadline Jul.1/2020

Phase 3 deadline: Jan.1/2021

Fully Compliant: Jul.1/2021

 

https://bit.ly/2JBQ8JL

 

https://bit.ly/2xHsKoC

 

Quebec

No

Not applicable

No

unknown

OPQ compounding standards are derived from USP standards. NAPRA Model Standards were based on OPQ's compounding standards. 

 

Ontario

Adopt

Approved Dec./17

Yes

Phase 1: Jan.1/2020

Phase 2: Jul.1/2020

Phase 3: Jan.1/2021

These standards replace the College’s 2006 Guideline for Compounding Preparations.

https://bit.ly/30A3cpT

 

https://bit.ly/2I3fjEb

 

Manitoba

Amend

Implementation schedule for the NAPRA Standards for Pharmacy Compounding of Non-Sterile Preparations: Dec.10/18

Yes

Phase 1: Apr.1/2020

Phase 2: Oct./2020

Phase 3: Jan./2021

Phase 4 (Hazardous Preparations and Level C requirements, if applicable): Apr.1/2021

 

 

https://bit.ly/30uDNO7

 

https://bit.ly/2K8L7Kl

 

Saskatchewan

Adopt

Adoption of NAPRA compounding standards Dec.15/17

Implementation plans approved Dec./18

No

Phase 1 + Level C Specific Requirements: Sept./2019

Phase 2: Mar./2020

Phase 3: Jul./2020

Phase 4: Dec./2020

 

https://bit.ly/2YOlqU2

 

https://bit.ly/2ScFAoa

 

Alberta

Adopt

2018

No

Priority 1: Jan.1/2020

Priority 2:  Jan.1/2020.

Priority 3: Jul.1/2020.

 

https://bit.ly/2XIiXJj

British Columbia

No

Not applicable

Yes

Not applicable

Decision pending.

Personal correspondence with CPBC.