Competency Mapped Sterile Compounding Courses

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Learning Objectives Hazardous Sterile Compounding:

Module 1

Module 1 provides a comprehensive foundation in sterile compounding practice. Learners will explore the differences between compounding and manufacturing, regulatory requirements, and decision-making around in-house versus outsourced hazardous compounding, including identification of hazardous components and risk assessment procedures. The module also covers best practices, reliable compounding information sources, and the distinct roles, qualifications, and conduct expectations of compounding and housekeeping personnel. In addition, participants will gain an understanding of sterile compounding environments, including design, environmental controls, air and surface sampling, pressure, temperature, humidity, and equipment certification, maintenance, and supporting equipment requirements.

Module 2 

Module 2 equips learners with knowledge of the practical skills needed for safe and effective sterile compounding. Participants will learn PPE requirements, proper garbing and doffing, hand and forearm hygiene, and cleaning, disinfecting, deactivation, and decontamination practices, with specific focus on hazardous sterile compounding, spill management, and exposure response. The module also covers aseptic workflow, critical sites, supply transfer, and proper hand and supply placement within compounding areas. In addition, learners will develop competency in ingredient sourcing and storage, compounding calculations, labeling, double checks, and handling of sterile preparations, as well as differentiating compounding types, risk levels, beyond-use dating, sterilization methods, and sterility testing requirements.

Module 3

Module 3 focuses on quality, oversight, and integration of sterile compounding practice. Learners will gain a clear understanding of record‑keeping requirements, including policies and procedures, compounding documentation, verification, traceability, environmental monitoring, incident reporting, corrective and preventative actions, and preparation recalls. The module also outlines the responsibilities of the sterile compounding supervisor, emphasizing staff training, competency assessment, quality assurance, and audit processes. Through case-based learning, participants will analyze and synthesize concepts from previous modules to apply regulatory, operational, and clinical knowledge in real-world sterile compounding scenarios.

Learning Objectives Non-Hazardous Sterile Compounding:

Module 1

Module 1 provides a comprehensive introduction to sterile compounding principles, covering the distinctions between compounding and manufacturing, regulatory requirements, and decision-making around in-house vs. outsourced compounding. It explores identification of hazardous components, best practices, and reliable information sources, while clarifying personnel roles, qualifications, and responsibilities within sterile compounding and housekeeping functions. The module also outlines expectations and restrictions for sterile compounding areas and examines the design, function, and environmental controls of sterile compounding environments. Key topics include air and surface sampling, pressure, temperature, and humidity requirements, as well as equipment certification, maintenance, and the proper use of supporting equipment to ensure compliance, quality, and safety.

Module 2

Module 2 equips learners with the knowledge of the practical, hands-on skills required for sterile compounding techniques, focusing on PPE donning and doffing, hand and forearm hygiene, and the safe movement of equipment and products into controlled areas. It covers cleaning and disinfecting standards, sterile compounding workflows, and core aseptic principles such as critical site protection, line clearance, and proper supply placement within the PEC. Learners gain knowledge in ingredient sourcing, hazardous identification, storage, calculations, double checks, labeling requirements, and handling of sterile preparations. The module also addresses patient-specific and batch compounding, compounding risk levels, beyond-use dating, sterilization methods, sterility testing, and quarantine requirements to support safe, compliant sterile compounding practices.

Module 3

Module 3 focuses on quality assurance, oversight, and integration of sterile compounding practices. It outlines comprehensive record‑keeping requirements, including policies and procedures, compounding logs and protocols, verification processes, traceability, environmental monitoring, incident reporting, and recall management for sterile compounded preparations. The module also defines the responsibilities of the sterile compounding supervisor, emphasizing staff training and competency assessment, quality assurance activities, audits, and effective use of policies and procedures. Through case-based learning, participants analyze and apply prior concepts to synthesize knowledge and reinforce best practices in real-world sterile compounding scenarios.

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