New NAPRA Compounding Standards
Posted on July 21, 2016
By: Irene Wasilewski, Application Consultant
What is NAPRA?
The National Association of Pharmacy Regulatory Authorities (NAPRA) is a voluntary association of Canadian provincial and territorial pharmacy regulatory bodies as well as the Canadian Forces Pharmacy Services. NAPRA members regulate the practice of pharmacy and operation of pharmacies in their respective jurisdictions in Canada. Their primary mandate is to protect the public.
NAPRA will replace its Guidelines to Pharmacy Compounding (2006) standard with a new set of 3 documents (Model Standards) for:
- non-hazardous sterile compounding (released)
- hazardous sterile compounding (expected release in 2016)
- non-sterile compounding (expected release in 2017)
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.
It is anticipated that each pharmacy regulatory body in Canada will adopt the NAPRA standards as the basic minimum compounding standard in their jurisdictions.
Additional requirements in the new standards include an onsite quality assurance program, increased oversight, beyond-use-dates and recall procedures, among others.
The Standards Development Process
NAPRA established an ad hoc Pharmacy Compounding Committee to steer the development of a suite of model standards for pharmacy compounding documents. 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.
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.
What does it mean for me?
At minimum, most pharmacies that perform compounding will likely have to revise their policies and procedures to meet the new standards. Some pharmacies may learn that their cleanrooms will require renovations to completely comply.
ARxIUM offers a number of products and consulting services that can assist in preparing and executing compliance with these standards. One of its cornerstone solutions is RIVA, a fully automated IV compounding system. Four Canadian hospitals have already implemented RIVA in their pharmacies.
For more information on NAPRA and to view a copy of the latest standards, please visit:
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