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New Pharmacy Compounding Standards: Phase 2 Begins
Phase 2 of the new compounding standards should be completed by May 2019.
The College would like to remind pharmacies and pharmacy professionals involved in sterile compounding that they should begin to focus on implementing the second phase of the new Model Standards for Pharmacy Compounding. This phase includes adopting the following standards as outlined in the New Model Standards document:
- Personnel;
- Policies and procedures;
- Maintenance logs; and
- Compounded sterile preparation protocols.
The recommended deadline for completion of Phase 2 is May 2019.
Have you Completed Phase 1?
The College would also like to remind Pharmacies and Pharmacy Professionals involved in sterile compounding, that the recommended target date for implementation of Phase 1 was November 2017. Phase 1 included a compounding risk assessment, GAP Analysis and site plan, as well as the following standards as outlined in the New Model Standards document:
- Compounded sterile preparation log
- Patient file
- Personnel conduct
- Aseptic compounding of sterile preparations
- Packaging
- Storage
- Transport and delivery of compounded sterile preparations
- Recall of sterile products of final compounded sterile preparations
Introducing the New Standards for Pharmacy 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 New Standards into your practice
The College has set out a four-year implementation plan for pharmacies and pharmacy professionals to adopt the new model standards for pharmacy 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 new 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 new compounding standards, the College has developed Gap Identification tools for the two new Model Standards for Pharmacy Compounding.
- Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations
- Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations
Stay Tuned
The College will continue to provide updates and information on the implementation phases and their respective deadlines.
For additional information, visit our dedicated resource page: Implementing the New Model Standards for Pharmacy Compounding.