Sterile Compounding Standards In Effect January 1, 2019

The January 1, 2019 deadline for the implementation of the Model Standards for Pharmacy Compounding of Non-Hazardous Sterile Preparations and the Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations is quickly approaching.

As previously shared in Pharmacy Connection, full compliance on all elements of the standards is expected by January 1, 2019. Please take the time to review the College’s Sterile Compounding Key Initiative and Frequently Asked Questions to ensure your pharmacy is prepared.

If a pharmacy needs additional time to ensure compliance with the standards, it is the College’s expectation that those pharmacies will prioritize their work to ensure that they comply with all critical elements of the standards by January 1, 2019 and submit a detailed action plan with risk-mitigation strategies to the College that outlines the steps the pharmacy will take, with timelines, towards full compliance.

As the College completes its visits to all pharmacies that engage in sterile compounding, it is evident that there has been a tremendous degree of hard work put in by pharmacies throughout the province as they prepared for the implementation of these important patient-safety standards. For those pharmacies that have submitted action plans, it is important that this work continues and that risk mitigation strategies are in place until a pharmacy’s full compliance with the standards is achieved.

It is also important that the College continues to provide support and guidance to pharmacies to help them achieve full compliance. Practice advisors will continue to provide assistance and support for pharmacies with action plans following the implementation deadline and the College will continue to provide information and resources to pharmacies to support their ongoing efforts in meeting the standards.

In the meantime, the College has posted Frequently Asked Questions on our website. Be sure to check them out.

Questions in the online FAQs include:

• What is required for January 1, 2019?
• What happens if our pharmacy is not able to meet the critical elements by January 1, 2019?
• What are the next steps for organizations that are not fully compliant with the NAPRA Model Standards for Pharmacy Compounding of Sterile Preparations by January 1, 2019 but have met the critical elements?
• Who can be a sterile Compounding Supervisor (CS) and what are they responsible for?
• Where can I find a “third party evaluator” to evaluate the sterile compounding supervisor?
• Do you have any suggestions or recommendations to aid us in requests regarding potential capital projects required to meet standards by January 1, 2019?
• Are there opportunities for regional models?
• Whom should I contact about specific questions that I have about operational procedures and polices?
• What are the College’s expectations for Beyond-Use-Dating (BUD)?
• What training and certification programs are recommended?
• What is required when organizations/pharmacies respond to assessment report action plans?
• How do I submit and respond to an action plan?
• What are the requirements for environmental testing?
• Does our hospital need to be concerned about the sterile implementation guidelines if there is no pharmacy on site?