Implementing NAPRA's Model Standards for Pharmacy Compounding

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Due to the unforeseen onset of the COVID-19 State of Emergency, the College Board approved extending the implementation plan timeline to adopt the Model Standards for Pharmacy Compounding of both Non-Hazardous and Hazardous Sterile Preparations from May 2021 to July 2022. 

Compounding, in respect to a drug, is defined as the mixing together of one or more other ingredients. Healthcare professionals who provide compounding related services and products to patients, must be able to demonstrate that a patient-healthcare professional relationship exists.

Evolving practice and increased awareness of the inherent dangers of compounding for the health of both patients and compounding personnel, led the National Association of Pharmacy Regulatory Authorities (NAPRA) to develop a suite of model standards for pharmacy compounding. These model standards will set national standards for pharmacy compounding, once adopted by provincial/territorial pharmacy regulatory authorities. Many pharmacy regulatory authorities across Canada have adopted, or are in the process of adopting, these model standards. 

In April 2017, the Board approved a four-year, phased implementation plan to adopt NAPRA’s Model Standards for Non-Hazardous and Hazardous Sterile Preparations, with the following recommended phases:

  • Phase 1 (gap analysis and site plan, personnel conduct): November 2017 
  • Phase 2 (personnel training, policies and procedures): May 2019 
  • Phase 3 (beyond-use dates, verification of facilities): May 2020 
  • Phase 4 (facility infrastructure): May 2021

In June 2020, College staff surveyed pharmacies to assess the status of their compliance with NAPRA’s Sterile Model Standards. Results from the survey indicated that hospital sites and community pharmacies are progressing towards compliance with the Sterile Model Standards. However, the majority (84%) of sites will not achieve full compliance by May 2021.

With the unforeseen onset of COVID-19, pharmacies have had to focus on immediate issues related to the pandemic. And, addressing these COVID-19 issues is a key reason why pharmacies cited that they are unable to meet the original May 2021 deadline. 

This one-time only extension of the deadline from May 2021 to July 2022 provides hospital and community pharmacies additional time to implement the Sterile Model Standards, in recognition of the COVID-19 pandemic. Where possible, earlier compliance with the Model Standards is expected. 

The College will continue to engage with pharmacies during the extension period to ensure they continue to progress towards implementing NAPRA’s Sterile Model Standards and are fully compliant by July 2022.

For more information on the College’s implementation plan for pharmacies and pharmacy professionals to adopt the new Model Standards for pharmacy compounding see 

Sep 30, 2020