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Sterile Compounding Standards: Phase 2 Implementation Deadline Approaching
The College would like to remind pharmacies and pharmacy professionals involved in sterile compounding that the second phase of the Model Standards for Pharmacy Sterile Compounding should be completed by May 2019.
Phase two of the College’s four-year implementation plan includes adopting the following standards as outlined in NAPRA’s Model Standards for Pharmacy Sterile Compounding:
- Personnel;
- Policies and procedures;
- Maintenance logs; and
- Compounded sterile preparation protocols
Introducing the Standards for Sterile Compounding
Compounding plays an important role in pharmacy practice, allowing individual ingredients to be mixed together in personalized strengths and dosages based on a patient’s needs and high-quality standards are needed to ensure preparation quality and safety when compounding drugs for patients.
Evolving practice as well as the increased awareness of the risks of compounding sterile preparations on the health of both patients and compounding personnel led NAPRA to develop new model standards for pharmacy compounding.
These model standards will set national standards for pharmacy compounding and are in the process of being adopted by health regulators across Canada.
Implementing the Standards into your Practice
The College has set out a four-year implementation plan for pharmacies and pharmacy professionals to adopt the model standards for pharmacy sterile compounding.
Those who compound sterile preparations will want to follow the four-year phased approach to ensure they meet the all the requirements by May 2021, when the new bylaws come into effect.
The standards include Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations, and Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations.
Gap Identification Tools
To help pharmacies and pharmacy professionals identify gaps in their compounding program and practices, and assist with developing plans to become compliant with the sterile compounding standards, the College has developed Gap Identification tools for the two Model Standards for Pharmacy Compounding of Sterile Preparations.
- Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations
- Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations
Additional Resources
