Key Questions on Sterile Compounding

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. The College has prepared a Sterile Compounding Key Initiative page to provide guidance to pharmacies and pharmacy professionals as they work to implement the standards. Here are a few of the common questions that the College has received so far.

What do I need to do by January 1, 2019? What if I can’t meet all of the standards by that date?

As communicated, the College expects full compliance on all elements of the standards by January 1, 2019. If a pharmacy needs additional time to meet compliance, then the expectation is that:

A. All critical elements of the standards, as specified in the assessment document are fully met by January 1, 2019:

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.

Please refer to information on Sterile Compounding Standards and Implementation on the OCP website, under Key Initiatives.

If I need to do an action plan, what should it include?

If a pharmacy has an action plan after their assessment, it is the expectation of the College that they will submit a detailed explanation of the corrective actions that have been put in place or a risk mitigation strategy that has been implemented until the long term corrective changes are addressed. The action plan must address the issues identified in enough detail that it clearly outlines the steps taken to mitigate risk, optimize outcomes and sufficiently rectify the issue. If there is not sufficient detail provided, the Practice Advisor will communicate back to the pharmacy to request further information. It is the responsibility of the pharmacy to continue to review their active action items and status on an ongoing bias until the issues are appropriately addressed. While the action plan is required 30 days from the date of the assessment, an ongoing collaborative dialogue may occur as the Practice Advisor assists the organization towards full compliance.

What training and certification programs are recommended in order to meet the standards?

The College does not recommend or endorse any particular training or certification programs. The pharmacy manager and/or compounding supervisor is responsible for ensuring that any training or certification programs meet the needs of the specific practice of the pharmacy/pharmacy professionals. Pharmacies are encouraged to collaborate with other hospitals or pharmacies in their LHIN to share best practices and operational advice.