This article originally appeared in the Winter 2018 issue and information has been updated.
College Council adopted NAPRA’s Model Standards for Pharmacy Compounding of Non-Sterile Preparations at their meeting in December 2017. Since then, a three-phased implementation date has been determined.
These new standards require pharmacy professionals to place a renewed focus on the preparation of non-sterile products in pharmacies.
IS YOUR PHARMACY ENGAGED IN COMPOUNDING?
Health Canada considers compounding to be the following:
“The combining or mixing together of two or more ingredients (of which at least one is a drug or pharmacologically active component) to create a final product in an appropriate form for dosing. It can involve raw materials or the alteration of the form and strength of commercially available products. It can include reformulation to allow for a novel drug delivery. Compounding does not include mixing, reconstituting, or any other manipulation that is performed in accordance with the directions for use on an approved drug’s labelling material. 1
Before compounding a non-sterile preparation, the need for the compounded product should be confirmed by checking for commercially available preparations in the Health Canada’s Drug Product Database and contacting manufacturers. 2 To comply with the Health Canada policy on compounding, this confirmation is required in order to validate the lack of product availability and avoid duplicating an approved drug.
Non-sterile preparations can be categorized as simple, moderate or complex 3 (as outlined in United States Pharmacopeia (USP) Chapter <795> Pharmaceutical Compounding – Nonsterile Preparations). A number of factors go into determining the type of preparation and level of risk when compounding preparations. Pharmacists and pharmacy technicians who compound non-sterile preparations should evaluate their practice, develop service-related procedures and implement appropriate quality controls for both patients and compounding personnel, with a view to guaranteeing the overall quality and safety of non-sterile preparations.
HOW TO PREPARE FOR THE STANDARDS
Implementation priorities and timelines for completion of each phase are:
Phase 1: January 1, 2020 - Assessing Risks and Gaps
Phase 2: July 1, 2020 - Personnel Training and Quality Assurance
Phase 3: January 1, 2021 - Facilities and Equipment
The standards are accompanied by a guidance document which provides pharmacists and technicians who compound non-sterile preparations with the details necessary to evaluate their practice, develop service-related procedures, and implement appropriate quality controls for both the protection of patients and compounding personnel.
Pharmacy professionals are encouraged to review
current policies and procedures, master formulations and Safety Data Sheets.
For more information, see How Are You Preparing for the New Standards on Non-Sterile Compounding? (Summer 2018).
- Health Canada. Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051). Retrieved at: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/policy-manufacturing-compounding-drug-products.html#a7
- Ontario College of Pharmacists. Quality and Safety in Compounding Non-Sterile Preparations. Retrieved at: http://www.ocpinfo.com/library/practice-related/download/Quality%20and%20Safety%20in%20Compounding%20Non-Sterile%20Preparations.pdf
- USP <795> Pharmaceutical Compounding—Nonsterile Preparations. Retrieved from: http://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/gc795.pdf