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DRAFT NAPRA Model Standards for Non-sterile and Sterile Compounding

Background

The National Association of Pharmacy Regulatory Authorities’ (NAPRA) is conducting a consultation to help further inform their work to develop model documents for pharmacy regulatory authority (PRA) use on the topic of compounding standards.

NAPRA develops key national model documents that its members, the PRAs across Canada including the Alberta College of Pharmacy (ACP), can use as desired. Having a national model document serves as a foundation for provincial/territorial requirements to help align practice and regulation across Canada. NAPRA model documents for PRA use can be used as seen fit by the PRA in each province or territory, based on the needs in that jurisdiction.

Your comments will be considered by NAPRA in the final development of the model compounding standards and will be made available to ACP Council for its consideration. Once finalized, it is ACP’s aim to adopt the national model standards for implementation in Alberta.

It is the responsibility of pharmacy professionals to review the requirements in the jurisdiction(s) in which they are regulated and follow the requirements set out by the PRA in those jurisdictions, which may differ from NAPRA’s example model documents.

ACP adopted the NAPRA Model Standards for Pharmacy Compounding of Non-Hazardous Sterile Preparations and Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations in 2016. ACP implemented its Standards for Pharmacy Compounding of Non-sterile Preparations and Guidance Document for Pharmacy Compounding of Non-sterile Preparations in 2018, which were adapted from the NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations and the associated Guidance Document for Pharmacy Compounding of Non-Sterile Preparations.

In 2024, NAPRA began a review and update of its suite of model documents on standards of practice for pharmacy compounding. The goal of the project is to update the documents to better align with the outcomes-based approach taken for other NAPRA model documents, update the content based on current evidence-informed references, address any issues/concerns with the current documents, and ensure the documents reflect current and anticipated future pharmacy practice.


Documents for review and comment period

NAPRA is currently seeking additional external input on the draft documents entitled Model Document for Pharmacy Regulatory Authority Use – Non-sterile Compounding Standards and Model Document for Pharmacy Regulatory Authority Use – Sterile Compounding Standards.

We ask that you only provide comments using the survey links provided in the consultation package, which will allow NAPRA to organize and synthesize your comments in a timely and efficient manner. If you are participating in this consultation on behalf of an organization, we ask that only one response per organization be submitted. The consultation will be open for comments until 9:59 p.m. MT on Sunday, March 15, 2026.