Non-sterile Compounding

Model Standards for Pharmacy Compounding of Non-sterile Preparations

The primary objective behind the introduction of the new Model Standards for Pharmacy Compounding of Non-sterile Preparations (the Standards) published by the National Association of Pharmacy Regulatory Authorities (NAPRA) was to build a framework that promotes and supports patient safety. 

The New Brunswick College of Pharmacists adopted these as the minimum standards to be met by pharmacists and pharmacy technicians when compounding non-sterile products and implementation of the Standards is currently underway.    

IMPLEMENTATION PLAN 

 

The implementation requirements have not changed however the College has set revised dates associated to the various phases of implementation as follows:

Phase 1 – January 1, 2020:  Gap analysis

Phase 2 – April 1, 2022:    Risk Assessment, personnel training, policies and procedures

Phase 3 – July 1, 2022:  Quality assurance

October 1, 2022:  Fully compliant

The College published the following resources to support pharmacy professionals navigating the implementation of the Standards.  

  • Guidance Document for Pharmacy Compounding of Non-sterile Preparations [LINK] published by NAPRA in conjunction with the Standards was accepted by Council as a resource for pharmacy professionals, if needed.
  • Implementation Timeline [LINK]
  • Checklist Overview of Phases 1, 2 and 3 [LINK]
  • FAQ document [LINK]- to address some of the issues either not addressed in the Standards or Guidance Document, or that lack specificity.
  • Assessing Knowledge and Technique when Compounding [LINK] – to accompany the Standards and Guidance documents, which will serve as a caution to members regarding some risks inherent in compounding.
  • Tips for preparing Risk Assessments and Master Formulas [Webinar recording]

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