Comprehensive Sterile Compounding Certificate Program

At the conclusion of the Comprehensive Sterile Compounding Certificate Program, participating pharmacists, pharmacy technicians, and healthcare professionals will be able to:

Introduction to Sterile Compounding and USP <797> Overview (3h)
UAN: 0201-0000-26-018-L07-P/T | Knowledge Based

• Define sterile compounding and differentiate it from nonsterile compounding
• Describe the scope and purpose of USP <797> and its role in sterile compounding practice
• Identify categories of compounded sterile preparations (CSPs) and their general characteristics
• Explain fundamental principles of aseptic technique and sources of contamination
• Describe the role of quality assurance and quality control in sterile compounding
• Identify basic components of sterile compounding environments, including primary and secondary engineering controls

Sterile Compounding Facilities, Engineering Controls, and Airflow Principles (3h)
UAN: 0201-0000-26-019-L07-P/T | Knowledge Based

• Describe facility design requirements for sterile compounding, including buffer rooms, anterooms, and segregated compounding areas
• Explain the function and differences between primary and secondary engineering controls
• Describe ISO classification levels and their role in maintaining air quality
• Explain airflow principles, including first air and unidirectional airflow, in sterile compounding environments
• Differentiate between positive and negative pressure environments and their appropriate use
• Identify factors that contribute to contamination risk within sterile compounding facilities

Maintaining Sterile Compounding Environments and Aseptic Processing (4h)
UAN: 0201-0000-26-020-L07-P/T | Application Based

• Demonstrate proper cleaning, disinfection, and sporicidal application techniques within sterile compounding areas
• Perform environmental monitoring procedures, including viable air and surface sampling
• Apply appropriate responses to environmental monitoring excursions and action levels
• Demonstrate proper staging and introduction of equipment and supplies into the PEC and SEC
• Perform aseptic techniques, including maintaining first air and avoiding contamination (shadowing)
• Select and apply appropriate sterilization methods (steam, dry heat, filtration) based on formulation characteristics
• Operate sterilization equipment (e.g., autoclave) following appropriate procedures and documentation requirements
• Perform filter integrity testing (e.g., bubble point test) and interpret results
• Apply beyond-use date (BUD) principles to compounded sterile preparations
• Perform required release checks, including visual inspection and labeling verification

Documentation, Quality Assurance, and Compliance in Sterile Compounding (3h)
UAN: 0201-0000-26-021-L07-P/T | Knowledge Based

• Describe the key documentation requirements for sterile compounding according to USP <797>
• Identify the components of a Master Formulation Record (MFR) and Compounding Record (CR)
• Outline the framework and purpose of a quality assurance (QA) program in sterile compounding
• List essential elements required in standard operating procedures (SOPs)
• Explain the role and importance of Certificates of Analysis (COAs) in component selection
• Recognize common resources used to support sterile compounding documentation and decision-making

Regulatory and Legal Framework for Sterile Compounding (3h)
UAN: 0201-0000-26-022-L03-P/T | Knowledge Based

• Identify key federal and state regulations governing sterile compounding
• Describe the differences between traditional compounding (503A) and outsourcing facilities (503B)
• Explain the role of the FDA, USP standards, and state boards in regulating compounding practice
• Summarize circumstances under which compounding is permitted and when it is restricted
• Define the concept of “essentially a copy” and its implications for compounding
• Recognize the purpose and limitations of FDA guidance documents in compounding practice
• Discuss enforcement risks and the potential consequences of non-compliance

Hazardous Drug Handling and USP <800> Compliance (4h)
UAN: 0201-0000-26-023-L07-P/T | Knowledge Based

• Define hazardous drugs and associated health risks
• Describe USP <800> requirements for hazardous drug handling
• Identify drugs that must be included on a facility’s hazardous drug list
• Differentiate between containment strategies and engineering controls
• Describe facility and environmental requirements
• Explain appropriate PPE selection and use
• Differentiate between deactivation, decontamination, cleaning, and disinfection
• Describe the role and responsibilities of the designated person
• Explain when an assessment of risk may be applied

REGISTER EARLY & SAVE $70!

Special promotional pricing will be automatically applied to all registrations completed six weeks before the beginning of class. No code necessary; does not apply to pharmacy student fees, EVP, or ACA Compound Academy. The best value in compounding training just got a little better.