Model Standards for Pharmacy Compounding
The College Standards for Sterile Compounding are now in effect.
The College Standards for Sterile Compounding came into effect on July 4, 2022.
The College has been communicating with registrants about this deadline since 2017, when the Board approved a phased implementation of the National Association of Pharmacy Regulatory Authorities (NAPRA) Model Standards for Sterile Compounding.
Pharmacy professionals involved in sterile compounding are expected to be in full compliance with the College Standards for Sterile Compounding.
The College Standards for Sterile Compounding include Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations, and Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations.
Evolving practice and increased awareness of the inherent dangers of compounding for the health of both patients and compounding personnel, led the Provincial Pharmacy Regulators, through NAPRA to develop a suite of model standards for pharmacy compounding. These Model Standards set national standards for pharmacy compounding, once adopted by provincial/territorial pharmacy regulatory authorities. Most pharmacy regulatory authorities across Canada have adopted, or are in the process of adopting, these model standards. The aim of the Model Standards is to provide pharmacy professionals who compound sterile preparations with the standards necessary to evaluate their practice, develop service-related procedures and implement appropriate quality controls for both patients and compounding personnel, with a view to ensuring the overall quality and safety of sterile preparations.
Patient safety was the driving force behind the development of the Model Standards. The Model Standards were developed in response to devastating consequences resulting from chemotherapy preparation issues in Canada and substandard facilities operating in the United States.
Bylaw Amendments for Model Standards
The following are the approved amendments to the Pharmacy Operations and Drug Scheduling Act (PODSA) Bylaws and Health Professions Act (HPA) Bylaws to adopt the NAPRA Model Standards for Sterile Compounding as the College Standards for Sterile Compounding:
- HPA Bylaws - Schedule F - Standards of Practice:
- PODSA Bylaws
- Professional Practice Policy (PPP) 64 - Guidelines to Pharmacy Compounding
QUESTIONS ABOUT THE COLLEGE STANDARDS FOR STERILE COMPOUNDING
As with all College requirements, the College’s role involves setting standards. Pharmacy professionals must decide how best to implement them within their organizations. With regards to the College Standards for Sterile Compounding, it is the responsibility of individual pharmacies and registrants to operationalize their application in pharmacy policies, procedures and facilities as well as in pharmacist and pharmacy technician practice. Sterile Compounding will be reviewed under the Practice Review Program using the Sterile Compounding Review Form.
Questions about compounding can be directed to [email protected]