Non-sterile Compounding Implementation Deadlines – February 17

As the deadlines for implementation of the Model Standards for Pharmacy Compounding of Non-sterile Preparations (the Standards) are approaching, the College is sending this reminder of resources such as the timeline and checklists available on the College website [LINK].  

The College has offered additional support (links below) to pharmacy professionals navigating the implementation of the Standards and most recently, compounding pharmacist Sebastian Denison was invited to speak at a webinar that focused on Risk Assessments and Master Formulation Sheets [Link to recording]. Simultaneous French translation was provided during the webinar, however the audio recording malfunctioned and is unfortunately not available. The content of the slides has been translated however and is accessible on the College website.

As a reminder, the items that must be complete no later than the approaching Phase 2 deadline (April 1, 2022) are:

  1. All Level A compounding requirements met*
  2. Personnel training and skills assessment complete
  3. Risk assessment complete
  4. Policies and procedures documented
  5. Looked ahead to Phase 3 requirements; considered early implementation

*If a compound is defined as Level A in the Standard, any pharmacy that compounds that product after April 1, 2022 must be compliant with the Standards. Requirements include:

  1. Staff involved in compounding a Level A product are properly trained.
  2. Facilities and equipment meet the requirements in the Standards.
  3. Product and preparation requirements in Section 6 of the Standards are met. This includes such things a SOP, MFR, BUD assignment, personnel conduct, ingredients used, documentation, etc. 

*More information is included in the Checklist Overview of Phases 1, 2 and 3 document on the College website. As published in the document, work on some of the detailed goals may be completed in phase 3 (i.e., work that has begun in phase 2).

Guidance for New Brunswick Pharmacy Professionals 

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]

For full Feb. 17 update, please click here {LINK}

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