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NAPRA Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations – now available

January 13, 2016

The National Association of Pharmacy Regulatory Authorities (NAPRA) has approved the final version of Standards for Compounding Non-Hazardous Sterile Preparations.

The new national standards were adapted from standards originally developed by the Ordre des pharmaciens du Quebec. Quebec based their standards on the General Chapter <797> of the United States Pharmacopeia – National Formulary (USP–NF) that been in effect in the United States since 2004.

The process to develop national standards was led by NAPRA’s ad hoc Committee on Pharmacy Compounding; and involved extensive consultation with experts and stakeholders across Canada. Concurrently, ACP also consulted with registrants and stakeholders; and feedback received contributed to shaping the new standards.

Based on a previous version of the document, ACP council has approved these standards in principle. Council will consider these standards for final approval at their June 2016 meeting. At that time, council will also determine an appropriate schedule for implementation of the standards.

In the near future, ACP’s Professional Practice Consultants (PPCs) will be scheduling visits to pharmacies where sterile products are prepared. The purpose of these visits is:

  • to ensure those who prepare sterile products are aware of the standards;
  • to assist licensees in assessing their compliance with the standards; and
  • to collect information that will assist council in determining an appropriate implementation schedule.

If you are involved in compounding sterile products, please become familiar with the NAPRA standards.