Pharmacy teams providing sterile compounding services must adhere to the National Association of Pharmacy Regulatory Authorities (NAPRA) Model Standards for Compounding Hazardous and Non-Hazardous Sterile Preparations approved by ACP Council. Compounding of sterile preparations is a complex activity which requires adherence to these standards to ensure these preparations are safe and of high quality. Some of the key requirements for sterile compounding include certification and sampling of the facilities and equipment, individualized policies and procedures, evidence-based beyond-use date practices, initial and ongoing training programs, and quality assurance programs.
Currently, all pharmacies that perform high-risk sterile compounding are inspected once every 18 months. All pharmacies that perform sterile compounding other than high risk are inspected once every three years at a minimum. To support pharmacies with their compliance to these standards, ACP is moving to a two-year inspection cycle for all pharmacies providing sterile compounding services starting in February 2025, regardless of risk level.
ACP is implementing these changes with patient safety as its goal. The updated inspection cycle enables ACP to complete more consistent and regular inspections of all pharmacies providing sterile compounding services. Compliance with these standards helps ensure the safety of patients receiving these preparations and pharmacy professionals who compound these preparations.
With this change, ACP encourages all pharmacy teams to review if they provide sterile compounding and, if so, ensure that they are following proper standards and procedures. Pharmacy teams who perform or plan to perform sterile compounding must report to the Alberta College of Pharmacy (ACP) that sterile compounding is or will be a part of their pharmacy practice.
