The National Association of Pharmacy Regulatory Authorities (NAPRA) established an ad hoc Pharmacy Compounding Committee to steer the development of a suite of model standards for pharmacy compounding documents. Three documents will be developed, with the first two (2) documents pertaining to non-hazardous and hazardous sterile preparations. The final document will address non-sterile preparations. NAPRA’s Board of Directors approved this initiative on the assumption that the Model Standards documents would be adapted from the compounding standards documents released by one of NAPRA’s members, l’Ordre des pharmaciens du Québec.
The Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations and the Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations were developed by the ad hoc committee. Early in the development stages, the committee benefitted from the contributions of a small group of pharmacists and pharmacy technicians involved with sterile compounding. The committee’s work was further supported by the feedback received from a wide range of stakeholders through the external consultation process.
The Model Standards for Pharmacy Compounding of Non-hazardous and Hazardous Sterile Preparations (“Model Standards”) were approved by NAPRA’s Board and were released in a staggered sequence. The first document released was the Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations. The second document released was the Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations. The final Model Standards document (non-sterile preparations) is expected to be released in 2017.
Current pharmacy practice for the preparation of sterile products in Canada includes many of the patient safety and quality assurance requirements of these new standards. However, additional requirements in the new standards include an onsite quality assurance program, increased oversight, beyond-use-dates and recall procedures, among others.
It is important to emphasize that the implementation of the Model Standards in Canada is under the authority of the respective provincial, territorial or Canadian Forces pharmacy regulatory bodies (“Colleges”). Each College will establish their respective process for the implementation of these standards in their jurisdiction.
The release of the Model Standards documents for pharmacy compounding will replace NAPRA’s Guidelines to Pharmacy Compounding (2006).
NOTE: A revision was made to both documents in November 2016. Specifically, the reference to Sterilization by Filtration in the Glossary of each document now reflects the correct reference to USP797 of 30 psi not 50 psi as previously published.
Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations - Revised November 2016
Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations - Revised November 2016
NAPRA's Guidelines to Pharmacy Compounding (2006)
Health Canada's Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051) (2009)