Sterile Compounding

In September 2016, the Ontario College of Pharmacists adopted the Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations (NAPRA, 2016) and the Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations (NAPRA, 2016) with an implementation date of January 1, 2019. These standards apply to all pharmacies, including hospitals, and drug preparation premises which undertake sterile compounding.

Sterile compounding is a high risk activity and preparation of sterile compounds requires comprehensive standards to ensure quality and safety. Knowledge of the environment in which these preparations are prepared, training of personnel, policies and procedures, and quality assurance procedures, as well as facilities and equipment standards, are required to ensure public safety.

The College’s mandate is to serve and protect the public. In accordance with public and patient expectations, these standards are important and need to be in place to protect patients. Patient safety will be our utmost priority in working with pharmacies that are implementing the standards.

Requirements for January 1, 2019

We acknowledge the work and efforts completed to date among pharmacies and institutions to comply with the standards and provide safe, high quality medications to patients. We also recognize that some pharmacies may need additional time to implement the needed infrastructure modifications in order to meet the requirements for facilities and equipment. Accordingly, the College expects that by January 1, 2019:

a) All pharmacies will be fully compliant with all critical elements of the standards, as specified in the assessment document.

b) Pharmacies that require additional time to achieve full compliance on all elements of the standards, including facility or equipment upgrades, will have an action plan towards full compliance – including timelines and risk mitigation strategies satisfactory to the College – in place and submitted to us within 30 days of their 2018 assessment. College Practice Advisors will work collaboratively with pharmacies to review and finalize action plans and remain available to assist towards compliance with the standards.

How Can You Prepare for Implementation?

As it is our expectation that pharmacies are currently engaged in preparing for the implementation of the standards by the deadline, your pharmacy is encouraged to:

a) Review the College’s revised assessment document that identifies the critical elements that must be met by January 1, 2019.

b) Conduct a gap analysis, if not already done, to compare against the standards, and particularly the critical elements, to assess gaps in pharmacy infrastructure, equipment, training, policies, procedures and practice. Once gaps are identified, resources should be directed to address those gaps; and

c) Check the College’s website and communication tools on a regular basis for updates and resources to support pharmacies in preparing for implementation of the new standards.

The College has sent letters to all pharmacies that perform sterile compounding to highlight these expectations. A copy of each letter is available below:

Ultimately, these standards are an important way of protecting patients and increasing patient safety. It is the College’s expectation that pharmacies are currently engaged in preparing for the implementation of the standards by January 1, 2019.