It is the responsibility of Designated Managers and pharmacy professionals to ensure that they stay up-to-date by reviewing this page and College communications regularly.
About the Standards
The implementation and adherence to these standards is an important way pharmacy professionals can protect patients, increase patient safety and protect pharmacy personnel.
Model standards represent the minimum requirements that must be met by all pharmacists and pharmacy technicians who compound non-sterile preparations. All practice sites must meet this standard and the performance of pharmacy professionals engaged in the practice of non-sterile preparation will be measured with these standards.
These standards have replaced the College’s 2006 Guideline for Compounding Preparations.
In recognition of the evolving COVID-19 pandemic situation and the need for pharmacy professionals to focus on continuity of care and minimizing public risk, on March 23, 2020, Board (Council) approved an extension of the deadlines for pharmacies to meet the standards. The updated timelines for completion of each phase are:
- Phase 1: January 1, 2020 – Assessing Risks and Gaps
- Phase 2: July 1, 2021 – Personnel Training and Quality Assurance
- Phase 3: January 1, 2022 – Facilities and Equipment
In Phase 1, evaluating the pharmacy’s current practice environment is a priority, with the goal of implementing appropriate procedures and quality controls to protect patients and compounding personnel. For more information on Assessing Risks and Gaps, please refer to the Pharmacy Connection article Implementation Timeline for Non-Sterile Compounding Standards.
In Phase 2, the priority will be the training and assessment of all personnel engaged in non-sterile compounding. Quality assurance processes need to be put in place to monitor compliance with the standards and safety in the system.
In Phase 3, the focus will be on ensuring that the facility and equipment for the preparation of hazardous and non-hazardous non-sterile compounds are in compliance with the standards. A quality assurance program will need to address facilities, equipment, personnel, compounded non-sterile preparations and documentation.
It is the College’s expectation that pharmacies are currently engaged in preparing for the implementation of the standards by January 1, 2022.
Key Resources from the College
To assist pharmacy professionals as they work to implement the standards, the College has provided:
- a fillable checklist for each phase of implementation
- frequently asked questions
- recording of a webinar held on November 4 (depending on your system, it may be necessary to download Adobe Connect to view the recording)
- Part 1 Slides (timelines and implementation dates, rationale for standards, overview of standards and guidance documents)
- Part 2 Slides (risk assessments, requirements for all levels, level B&C requirements, compounding hazardous preparations)
- Part 3 Slides (risk-based approach, patient assessment, challenges and alternatives, key resources, assessment criteria)
In addition, please see the assessment criteria document and list of relevant Pharmacy Connection articles below.
The College has produced a Non Sterile Preparations Assessment Criteria document. This document is intended to be used by pharmacy professionals to assess the gaps between current processes/practices at the pharmacy and the requirements of the standards.
The document lays out each standard and the accompanying section in the guidance document to illustrate specific insights or activities required to ensure adherence to the standard. Pharmacy professionals can “check off” each standard as it is met and track their progress at meeting the standards. However, this document is not meant to replace the standards.
During assessments of pharmacies performing non-sterile compounding, College operations advisors will be looking for completion of Phase 1 and Phase 2 activities as those deadlines have now passed.
College operations advisors can also help answer questions about the Phase 3 implementation, which is to be completed by January 1, 2022.
Pharmacy Connection Articles
- Implementation of Non-Sterile Compounding Standards: Tips from the College’s Operations Advisors (Summer 2021)
- Master Formulation Records and Compounding Records: What’s the Difference? (Winter/Spring 2021)
- Non-Sterile Compounding Phase 2: How to Meet the July 1, 2021 Deadline (Winter/Spring 2021)
- Training and Facilities Questions (Fall 2020)
- Staying on Track for Full Implementation (Spring/Summer 2020)
- Phase 2 Implementation (Winter 2020)
- Preparing for Phase 2 (Fall 2019)
- The Community Pharmacy Experience (Summer 2019)
- A Closer Look at Personal Protective Equipment (Summer 2019)
- Non-Sterile Compounding FAQs (Summer 2019)
- Preparing for the First Phase of Non-Sterile Compounding Compliance: The Hamilton Health Sciences Experience
- Timelines Announced for Non-Sterile Compounding Standards (Winter 2019)
- How Are You Preparing for the New Standards on Non-Sterile Compounding? (Summer 2018)
- New Model Standards Apply to All Pharmacies Performing Non-Sterile Compounding (Spring 2018)
- Compounding: Are You Doing It? (Winter 2018)