Non-Sterile Compounding Standards and Implementation

In December 2017, Council adopted the National Association of Pharmacy Regulatory Authorities (NAPRA) Model Standards for Pharmacy Compounding of Non-Sterile Preparations. The standards are accompanied by a Guidance Document for Pharmacy Compounding of Non-Sterile Preparations.

The standards apply to ALL pharmacies that perform any type of non-sterile compounding in any quantity, whether once in a while or every day.

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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.

Implementation

On December 10th, 2018, Council approved a three-phased approach for the implementation of the standards. Implementation priorities and timelines for completion of each phase are:

  • Phase 1: January 1, 2020 – Assessing Risks and Gaps
  • Phase 2: July 1, 2020 – Personnel Training and Quality Assurance
  • Phase 3: January 1, 2021 – 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, 2021.

Self-Assessment Criteria

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.

As outlined above, it is the College’s expectation that pharmacies will have assessed their risks and gaps by January 1, 2020 to prepare for the implementation of the personnel training and quality assurance components by July 1, 2020.

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