Sterile Compounding FAQs

What is required for January 1, 2019?

The College supports a stepwise approach to facilitate full compliance with the NAPRA Model Standards for Pharmacy Compounding of Sterile Preparations in a manner that serves and protects the interest of the public in ensuring access to care.

We acknowledge the work and efforts to date among pharmacies and institutions to comply with the standards and provide safe, high- quality medications to patients. We also recognize that pharmacy operations are diverse with various models and programs and that some pharmacies may require additional time to implement the needed infrastructure modifications to meet the requirements for facilities and equipment.

While the College expects full compliance on all elements of the standards, if a pharmacy requires additional time to achieve that, including facility or equipment upgrades, then it is expected that at a minimum, all critical elements of the standards, as specified in the assessment document, will be met by January 1, 2019. An action plan towards full compliance – including timelines and risk mitigation strategies satisfactory to the College for the other elements that are not compliant – must be submitted to the College within 30 days of their 2018 assessment. College Practice Advisors will work collaboratively with pharmacies and institutions to review and finalize action plans and remain available to provide feedback on plans for compliance.

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

What happens if our pharmacy is not able to meet the critical elements by January 1, 2019?

The College expects full compliance on all critical elements of the standards by January 1, 2019. If a pharmacy anticipates that it will not be able to achieve full compliance with all critical elements, College Practice Advisors will work collaboratively with the pharmacy to review risk mitigation strategies and action plans towards full compliance with all critical elements. The critical elements are required to ensure patient safety. The College will exercise its regulatory authority to serve and protect the public if there are any patient safety concerns that have not been mitigated.

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?

The College will continue to use a stepwise approach to facilitate full compliance. The next set of required elements, including timelines, will be developed once we have completed our 2018 cycle. The College expects pharmacies and institutions to continue working toward compliance with all elements of the standards to ensure patient safety and to mitigate risk.

Who can be a sterile Compounding Supervisor (CS) and what are they responsible for? (,, NAPRA Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations and NAPRA Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations)

The CS is a Pharmacist or Pharmacy Technician designated by the Designated Manager (DM)/pharmacy administrator to supervise activities related to the compounding of non-hazardous and /or hazardous sterile preparations. This person works with the pharmacy manager or pharmacy department head and with the compounding personnel. They must have the appropriate mix of education and experience and possess previous work experience supervising activities of a similar nature.

In addition to successfully completing training (i.e., courses) in the compounding of sterile preparations, he or she must have maintained up-to-date knowledge. The CS must be able to demonstrate the competencies required to manage a safe sterile-preparation compounding area.

The CS develops, organizes and oversees all activities related to sterile preparation compounding. The pharmacy manager or pharmacy department head assigns these responsibilities.

In accordance with the appropriate supervision protocol and appropriate quality control measures, the sterile CS may assign technical tasks related to sterile-preparation compounding to a pharmacy assistant with the appropriate training, using a formal delegation process that complies with the requirements for delegation in Ontario. Currently in Ontario, only pharmacists are able to delegate controlled acts within the scope of pharmacy practice.

Responsibilities of the CS (for complete details, refer to NAPRA Model Standards for Pharmacy Compounding of Non- hazardous Sterile Preparations and NAPRA Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations)

The responsibilities of the sterile compounding supervisor include (but are not limited to) ensuring that:

  • A personnel training and assessment program is implemented.
  • Personnel know and fully comply with policies and procedures.
  • Appropriate measures are taken to ensure the safety of personnel during each preparation.
  • Policies and procedures covering all activities are developed, regularly reviewed, updated and followed.
  • The facilities and equipment used to compound sterile preparations meet requirements and are maintained, calibrated or certified.
  • The compounding process yields high-quality sterile preparations that are safe for patients.
  • The available, recognized scientific literature is used to determine stability and to establish the beyond-use date (BUD) for each sterile preparation.
  • A quality assurance program is implemented and followed.
  • Current editions of mandatory and supplementary references are available and updated regularly.
  • Required records are completed, maintained and readily available for audit and inspection purposes.

Where can I find a “third party evaluator” to evaluate the sterile compounding supervisor? Can you recommend a company? ( NAPRA Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations and NAPRA Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations)

A third party evaluator is a pharmacist or pharmacy technician, selected by the Compounding Supervisor (CS), with expertise in sterile preparation compounding who is free of any real or perceived conflict of interest with the individual being evaluated. The third party evaluator must be independent (at arm’s length) from the facility/pharmacy to ensure an impartial competency assessment.

The College does not recommend or endorse a particular pharmacy professional for this role. The CS must ensure that the third-party evaluator is qualified and has training that covers the compounding of sterile preparations and certification that his or her competencies (which include the same elements as those of a competency assessment program for compounding personnel) are being maintained and developed. Any third-party evaluator or model used must mitigate risk and meet the intended outcome of this standard.

Do you have any suggestions or recommendations to aid us in requests regarding potential capital projects required to meet standards by January 1, 2019?

The stepwise approach recognizes that capital renovations may be required as part of future renovations or projects but focuses on the achievement of the critical elements for January 1, 2019.

The College has been working with the Health Capital Investment Branch at the Ministry of Health and Long-Term Care to clarify expectations and work toward full compliance of the standards. The College has and will continue to provide the Health Capital Investment Branch information regarding status of the site in meeting the standards to assist in the capital funding approval process. The capital planning process outlined in the Ministry/LHIN Joint Review Framework for Early Capital Planning is available on the LHIN website.

Are there opportunities for regional models?

The College has collaborated with the North East LHIN to develop a regional strategy for hospital pharmacy. The strategy provides a framework to guide LHINs and hospitals to work together to make regional decisions that will ensure hospitals, as a region, collectively provide medication management services according to standards. The strategy acknowledges the importance of broader medication management practices but focuses on sterile compounding and prioritizes patient safety through the critical elements, patient access to services and optimizing volume of service delivery as a region. LHINs and hospitals may choose to use this framework to inform a coordinated regional approach to capital funding requests that accurately reflect the needs of the region. If LHINs and hospitals determine that there is a need for capital investments after going through the process outlined in the strategy, a LHIN-coordinated submission is recommended. The strategy will be posted on the College website.

Whom should I contact about specific questions that I have about operational procedures and polices?

Determining the specific details of policies and procedures is the responsibility of the Designated Manager (DM)/administrator and/or the Compounding Supervisor (CS) and these are not reviewed or approved by the College. Practitioners are encouraged to collaborate with pharmacy directors and hospitals in their LHIN to share best practices and operational advice. Other resources include the references provided in the Standard and professional associations (CSHP, OHA, etc.). College practice advisors will identify any concerns or red flags. The College’s approach focuses on achieving intended outcomes using risk mitigation strategies. The College does not approve operational procedures and policies.

What are the College’s expectations for Beyond-Use-Dating (BUD)?

For January 1, 2019, the College’s expectations are that the critical elements for the BUD standard are fully met. Specifically, that the organization has conducted a risk assessment on the established BUDs and must have met the following critical elements:

  • High-risk preparations must meet the BUDs.
  • The pharmacy must have a policy in place to specify the BUD of single -dose vials.

The College expects all organizations to be working towards meeting all NAPRA BUD requirements to ensure patient safety. The College acknowledges that it will take time to become fully compliant with these requirements and has adopted a stepwise approach focused on risk mitigation.

Organizations choosing to extend the BUD of a sterile preparation should review:

There must be evidence to support the extended beyond use date.

What training and certification programs are recommended?

The College does not recommend or endorse a particular training/certification program. 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 pharmacy and pharmacy professionals. Pharmacies are encouraged to collaborate with other hospitals or pharmacies in their LHIN to share best practices and operational advice.

What is required when organizations/pharmacies respond to assessment report action plans?

After the assessment has occurred, the organization will receive the assessment report as well as a detailed explanation of how to access the College software system (Quill) in order to respond to the required action plan. Individual deficiencies identified during the assessment will be presented as ‘Infractions’ on the Quill site. Each infraction requires a response from the organization.

The action plan submitted must address the issues identified in enough detail to clearly outline the steps taken to mitigate risk, optimize outcomes and sufficiently rectify the issue. If sufficient detail is not provided, the Practice Advisor will communicate back using Quill requesting further information.

It is the responsibility of the organization to continue to review their active infractions and status on an ongoing basis until the issues are appropriately addressed.

The action plan is required 30 days from the date of the assessment; however, an ongoing collaborative dialogue may occur as the Practice Advisor assists the organization with steps towards full compliance.

How do I submit and respond to an action plan?

If an organization/pharmacy has an action plan after their assessment, it is the expectation of the College that they will submit it through the College software system (Quill).

What are the requirements for environmental testing? ( NAPRA Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations and NAPRA Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations)

An environmental verification program must be established to ensure that the facility is maintained to established specifications. The NAPRA Model Standards for Pharmacy Compounding detail the expected requirements in section The program should be developed in collaboration with microbiology. A featured article on the implementation of an environmental verification program will be available in an upcoming issue of Pharmacy Connection.

Does our hospital need to be concerned about the sterile implementation guidelines if there is no pharmacy on site?

The College has official oversight of hospital pharmacies and to ensure that a safe medication management system is in place for patient safety. According to the Drug and Pharmacies Regulation Act, s.119, a hospital pharmacy is defined as the primary location or locations in the hospital where drugs are compounded, dispensed or supplied from for hospital patients by a hospital, together with any other location in the hospital where drugs are stored or supplied from. Therefore, if the hospital performs any sterile compounding, then the sterile requirements would apply. If the sites are receiving any compounded preparations from other sites or external sources, they must ensure that all compounded preparations received meet NAPRA requirements including proper temperature during transport.