Compounding – Sterile

The College adopted the NAPRA Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations and the Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations, following approval at the September 2016 Board meeting with an implementation date of January 1, 2019.

These standards apply to all pharmacy professionals in all practice settings that engage in sterile compounding in any capacity and are an important way to ensure patient safety and protect pharmacy personnel.

Pharmacy compounding of sterile preparations is a high risk activity which requires comprehensive standards to ensure overall quality and safety. The Designated Manager/department head must ensure, with the best interest of the patient in mind, that the pharmacy has the resources necessary to compound a preparation of good quality in a safe and appropriate manner. Knowledge of the environment in which these preparations are compounded, training of personnel, policies, procedures and quality assurance processes, as well as standards for facilities and equipment are required to protect patients.

Key Resources from the College