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CE Compounding Sterile Preparations

Compounding and Sterile Preparations Continuing Education teaches pharmacists and technicians the latest USP 795, 797, and 800 standards, beyond‑use dating, and proper garbing and hygiene to ensure safe, compliant compounding.

Who Should Take This

Pharmacists and pharmacy technicians who regularly compound sterile or nonsterile medications benefit from this course. It is designed for professionals with baseline compounding experience seeking to update their knowledge of USP chapter requirements, aseptic technique, hazardous drug handling, and quality assurance practices.

What's Included in AccelaStudy® AI

Adaptive Knowledge Graph

Practice Questions

Lesson Modules

Console Simulator Labs

Exam Tips & Strategy

20 Activity Formats

Course Outline

68 learning goals

1 USP 795 Nonsterile Compounding

2 topics

Nonsterile compounding standards

Identify the scope and applicability of USP 795 including the types of preparations covered, the distinction between simple and complex compounding, and exemptions from the chapter.
Explain the requirements for master formulation records and compounding records including required elements, review and approval processes, and record retention periods.
Describe component selection standards for nonsterile compounding including USP-NF grade chemicals, certificate of analysis requirements, and ingredient sourcing documentation.
Identify beyond-use dating rules for nonsterile compounded preparations including default dating for aqueous, nonaqueous, and solid preparations when stability data is unavailable.

Quality assurance in nonsterile compounding

Explain the personnel training and competency requirements under USP 795 including initial training, ongoing assessment, and documentation of compounding personnel qualifications.
Analyze the quality assurance measures required for nonsterile compounding including end-product verification, weight checks, pH testing, and visual inspection procedures.
Evaluate a pharmacy's nonsterile compounding practices against USP 795 requirements to identify compliance gaps and recommend corrective actions.
Design a comprehensive quality assurance program for a nonsterile compounding pharmacy including formulation verification, equipment calibration, environmental monitoring, and complaint handling.

2 USP 797 Sterile Compounding

3 topics

Classified areas and engineering controls

Identify the ISO air quality classifications required for sterile compounding areas including ISO 5 primary engineering controls, ISO 7 buffer areas, and ISO 8 ante-areas.
Explain the types of primary engineering controls used in sterile compounding including laminar airflow workbenches, biological safety cabinets, compounding aseptic isolators, and CACIs.
Describe HEPA filtration principles including particle capture efficiency, filter integrity testing, and the relationship between air changes per hour and ISO classification maintenance.
Analyze the design requirements for a sterile compounding suite including room layout, pressure differentials between classified areas, pass-through chambers, and personnel and material flow patterns.

Sterile compounding categories and BUD

Identify the USP 797 beyond-use dating categories based on conditions of preparation and storage and the corresponding maximum BUD for each category.
Explain how sterility testing and endotoxin testing requirements change based on batch size, risk level, and beyond-use dating assignment under the revised USP 797 framework.
Analyze the impact of preparation conditions on beyond-use dating assignment and determine the appropriate BUD category for specific compounding scenarios.

Environmental monitoring

Identify the environmental monitoring requirements under USP 797 including viable and nonviable air sampling, surface sampling, and personnel sampling frequencies.
Explain the action levels for environmental monitoring results and the corrective actions required when viable or nonviable particle counts exceed specified thresholds.
Design an environmental monitoring program for a sterile compounding pharmacy including sampling locations, frequencies, methods, action level documentation, and trend analysis reporting.

3 USP 800 Hazardous Drug Handling

2 topics

Hazardous drug identification and risk

Identify the NIOSH criteria for classifying drugs as hazardous including carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity, and genotoxicity.
Explain the assessment of risk framework under USP 800 including the requirement for a facility-specific list of hazardous drugs and the hierarchy of controls for exposure prevention.
Describe the types of exposure to hazardous drugs including inhalation, dermal absorption, ingestion, and needlestick and the routes of exposure most relevant to pharmacy personnel.

Containment and protection

Identify the engineering controls required for hazardous drug handling including containment primary engineering controls, externally vented BSCs, and closed-system transfer devices.
Explain personal protective equipment requirements for hazardous drug handling including chemotherapy-rated gloves, gowns, respiratory protection, and eye protection selection criteria.
Describe deactivation, decontamination, cleaning, and disinfecting procedures for surfaces exposed to hazardous drugs including approved deactivation agents and procedure sequencing.
Analyze a pharmacy's hazardous drug handling practices against USP 800 requirements to identify compliance gaps in receiving, storage, compounding, administration, and waste disposal.
Design a comprehensive hazardous drug safety program including risk assessment, engineering controls, PPE protocols, decontamination procedures, spill management, medical surveillance, and training documentation.

4 Beyond-Use Dating Determination

2 topics

Stability data and dating

Identify the sources of stability data for compounded preparations including peer-reviewed literature, manufacturer data, USP default dating, and stability-indicating assay methods.
Explain the factors affecting stability of compounded preparations including pH, temperature, light exposure, container type, preservative effectiveness, and water activity.
Describe the methodology for stability-indicating analytical testing including HPLC validation, degradation studies, and acceptance criteria for extending beyond-use dates.

BUD assignment and documentation

Analyze stability data from published literature to determine an appropriate beyond-use date for a compounded preparation considering storage conditions and testing methodology.
Evaluate the appropriateness of extending beyond-use dates beyond USP defaults based on available stability data and the documentation required to support extended dating.
Design a beyond-use dating policy for a compounding pharmacy that addresses default dating, literature-based dating, stability testing criteria, and documentation standards.

5 Garbing Procedures and Personnel Hygiene

2 topics

Garbing requirements

Identify the garbing requirements for sterile compounding personnel including shoe covers, head cover, face mask, beard cover, non-shedding gown, and sterile gloves in proper donning order.
Explain the hand hygiene procedures required before sterile compounding including proper handwashing technique, duration, antiseptic agents, and the prohibition of hand jewelry and artificial nails.
Describe the sterile gloving technique including inspection for defects, proper donning without contamination, glove disinfection with sterile 70% IPA, and re-gloving criteria during compounding.

Garbing compliance

Analyze common garbing errors and contamination risks including improper donning sequence, garb breaches during compounding, and environmental factors that compromise garb integrity.
Evaluate fingertip and thumb sampling results to assess personnel hand hygiene and gloving technique effectiveness and determine when retraining is required.
Design a garbing competency assessment program that includes observation checklists, fingertip sampling protocols, corrective action triggers, and ongoing monitoring schedules.

6 Media Fill Testing and Personnel Competency

2 topics

Media fill procedures

Identify the purpose and requirements of media fill testing for sterile compounding personnel including initial qualification, ongoing frequency, and conditions requiring requalification.
Explain the media fill test procedure including soybean casein digest media preparation, aseptic manipulation simulation, incubation conditions, and pass-fail criteria.
Describe growth promotion testing requirements for media fill samples including positive and negative controls, incubation duration, and documentation of growth promotion results.

Competency assessment and remediation

Analyze media fill test failures to identify potential root causes including aseptic technique errors, environmental contamination, garbing issues, and media preparation problems.
Evaluate the complete personnel competency assessment program for sterile compounding including didactic training, written examination, practical demonstration, and media fill qualification.
Identify the corrective actions required after a media fill test failure including immediate suspension from compounding, retraining requirements, and requalification procedures.
Design a comprehensive sterile compounding training and competency program including didactic modules, hands-on skills labs, media fill testing schedules, and annual recertification procedures.

7 Sterility Assurance and Aseptic Technique

2 topics

Aseptic technique principles

Identify the critical sites in sterile compounding that must remain sterile including needle hubs, syringe tips, vial septums after swabbing, and IV bag injection ports.
Explain proper aseptic manipulation technique for needle-and-syringe compounding including vial entry, solution withdrawal, air bubble management, and final volume verification.
Describe ampule opening and filtering technique including proper scoring, breaking, withdrawal using filter needles or straws, and the rationale for filtering particulate matter.

End-product testing and release

Identify the triggers for end-product sterility testing under USP 797 including batch size thresholds, extended beyond-use dating, and high-risk compounding conditions.
Explain bacterial endotoxin testing requirements for compounded sterile preparations including test methods, endotoxin limits by route of administration, and testing frequency.
Analyze compounding scenarios to determine whether end-product testing is required and the appropriate testing methodology based on preparation type, volume, and intended use.
Design a comprehensive sterility assurance program integrating aseptic technique training, environmental monitoring, media fill testing, end-product testing triggers, and continuous quality improvement.

8 Compounding Documentation and Regulatory Compliance

2 topics

Documentation requirements

Identify the required elements of master formulation records for both sterile and nonsterile compounding including ingredients, equipment, compounding steps, quality checks, and packaging.
Explain the compounding record documentation requirements including lot numbers, quantities, personnel identification, quality checks performed, and deviations from the master formulation.
Analyze documentation deficiencies in compounding records to assess their impact on product quality, traceability, and regulatory compliance.

Regulatory compliance

Describe the regulatory distinction between 503A pharmacy compounding and 503B outsourcing facility operations including registration, inspection, and reporting requirements.
Evaluate a compounding pharmacy's readiness for state board of pharmacy inspection by auditing documentation, environmental monitoring data, personnel records, and standard operating procedures.
Design a regulatory compliance maintenance program for a compounding pharmacy that addresses USP chapter updates, state regulation changes, personnel training, and continuous inspection readiness.

9 Compounding Quality Control and Patient Safety

2 topics

Quality control testing

Identify the types of quality control tests applicable to compounded preparations including potency testing, pH measurement, visual inspection, weight variation, and particulate matter assessment.
Explain the role of third-party analytical testing laboratories in verifying compounded preparation quality including when to send samples, turnaround expectations, and result interpretation.
Analyze the results of potency testing for compounded preparations and determine whether products meet acceptable ranges and what corrective actions are needed for out-of-specification results.

Patient safety and recall

Describe the procedures for compounded preparation recall including patient notification, product retrieval, root cause investigation, and regulatory reporting obligations.
Evaluate the risk-benefit considerations for compounding versus commercially available alternatives including patient access, quality assurance burden, cost implications, and liability exposure.
Design a compounding incident investigation and corrective action protocol that addresses product quality complaints, adverse event reports, and continuous quality improvement.

10 Compounding Equipment and Facility Maintenance

1 topic

Equipment calibration and certification

Identify the compounding equipment requiring regular calibration including analytical balances, pH meters, automated compounding devices, and temperature monitoring instruments.
Explain the certification requirements for primary engineering controls including initial certification, recertification frequency, and the standards used for HEPA filter integrity and airflow testing.
Analyze equipment maintenance logs and certification reports to identify patterns that may indicate deteriorating performance or upcoming compliance failures.
Design a preventive maintenance and calibration schedule for all compounding equipment that ensures continuous regulatory compliance and minimizes unplanned downtime.

Scope

Included Topics

USP 795 standards for nonsterile compounding including personnel training, component selection, beyond-use dating, master formulation records, compounding records, and quality assurance requirements.
USP 797 standards for sterile compounding including classified areas, primary engineering controls, personnel garbing and hygiene, media fill testing, environmental monitoring, and beyond-use dating by category.
USP 800 requirements for hazardous drug handling including assessment of risk, containment strategies, personal protective equipment, deactivation and decontamination procedures, and medical surveillance.
Beyond-use dating determination for compounded preparations including stability data sources, USP default dating, extended dating based on testing, and documentation requirements.
Clean room design and environmental requirements including ISO classifications, primary engineering controls (BSCs, CAIs, CACIs), HEPA filtration, pressure differentials, and temperature and humidity control.
Garbing procedures for sterile compounding including hand hygiene, donning sequence, glove selection and sterile gloving technique, garb contamination risks, and garbing area design.
Media fill testing and personnel competency assessment including initial and ongoing media fill requirements, growth promotion testing, fingertip sampling, and corrective actions for failed tests.
Sterility assurance measures including aseptic technique principles, needle-and-syringe manipulation, vial and ampule entry technique, batch preparation considerations, and end-product testing triggers.

Not Covered

Industrial-scale pharmaceutical manufacturing, cGMP requirements for drug manufacturers, or FDA inspection procedures for manufacturing facilities.
Detailed microbiology or infectious disease management beyond understanding contamination sources and sterility assurance in compounding.
Radiopharmaceutical compounding or nuclear pharmacy practices beyond general sterile compounding principles.
Compounding for veterinary patients beyond the general principles of USP chapter compliance.

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