Implementation of Non-Sterile and Sterile Compounding Standards

March 8th, 2019

On February 16, 2019, the Board approved implementation guides to accompany the previously- adopted standards for non-sterile and sterile compounding. Both the standards and the new implementations guides are now available on the Standards, Guidelines, Policies and Positions page of the NLPB website.

These standards represent the minimum standards that all registrants engaged in pharmacy compounding are expected to meet. It is recognized that the implementation of these standards may include significant changes to staff training, policies and procedures, and documentation processes, and, depending on the type of compounding performed, equipment and facility design.

As sterile compounding is mostly performed in hospitals throughout the province, hospital pharmacies, in particular, will need time to plan and complete the complex renovations that are necessary to meet facility requirements for this higher risk practice.

Additionally, the standards for non-sterile compounding will have broad impacts as all pharmacies compound to some extent in order to meet their patients’ needs.

Recognizing these challenges, the Board used the input of a group of registrants to develop the implementation guides with the intention of helping registrants plan implementation activities using a structured, phased process with specific timelines.

The first phase of implementation, to be completed by the end of this year, primarily involves preparation and planning. The Board will be providing gap analysis tools to assist with this process.

By meeting these new standards, pharmacies will benefit from:

  • Improved safety standards for patients, pharmacy practice, and the pharmacy team; and
  • Ensuring consistency of standards and a minimum level of practice across the profession.

Registrants should start by reviewing the compounding standards that are applicable to their practice along with the related implementation guides. During the Professional Practice Webinar on April 9, 2019, the Board will provide an overview of the new implementation schedules and answer any questions that registrants may have. Additional webinars and communications to support registrants will also follow throughout each implementation phase. Stay tuned!

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