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Health Canada GUI-0116

Meaning

Health Canada GUI-0116 is a specific guidance document issued by Health Canada, the federal department responsible for national health policy, which outlines the comprehensive regulatory requirements for drug compounding in Canada. This document provides essential, detailed guidance for compounding pharmacies regarding facility standards, equipment calibration, personnel qualifications, and the quality assurance necessary for sterile and non-sterile preparations. Adherence to GUI-0116 is critical for compounding pharmacies to ensure the safety, quality, and efficacy of the customized hormonal preparations they dispense to patients. It serves as the authoritative framework for good compounding practices across the country.