Apply USP <795> requirements to a non-sterile compounding workflow and documentation set.
Healthcare & Pharmaceutical Management
Pharmacy Compounding Practice and Sterile Preparation Standards
Train pharmacy compounding staff to meet USP sterile and non-sterile standards, run a compliant cleanroom and document every batch to a standard that survives inspection.
🗓️Duration5 training days
📚Content4 modules · 8 sessions
🎓On completionAccredited attendance certificate
About the programme
Course Overview
A compounded preparation carries none of the safety margin built into a commercially manufactured product, so the standards governing non-sterile and sterile compounding exist to replace that margin with process control. This course works through USP <795> for non-sterile compounding, USP <797> for sterile preparations and USP <800> for handling hazardous drugs, translating each standard into daily pharmacy practice. Participants examine cleanroom design and classification, environmental monitoring programmes and the aseptic technique competency assessments personnel must pass before compounding sterile products. The programme covers beyond-use dating and the stability data needed to justify it, alongside hazardous drug handling requirements that protect compounding personnel. Later sessions focus on the documentation that makes compounding defensible: master formulation records, batch logs and the quality assurance checks that catch an error before it reaches a patient. Participants finish able to run a compounding operation that is ready for inspection at any time, not only when one is scheduled.
Expected Learning Outcomes
Meet USP <797> sterile compounding requirements across preparation, environment and personnel practice.
Design a cleanroom environmental monitoring programme that meets required classification levels.
Assess personnel competency in aseptic technique before authorising sterile compounding duties.
Determine a defensible beyond-use date using applicable stability and sterility data.
Implement USP <800> controls for handling, storing and disposing of hazardous compounded drugs.
Build master formulation records and batch documentation that withstand inspection review.
Who Should Attend
Compounding pharmacists and pharmacy technicians preparing sterile and non-sterile products.
Pharmacy quality assurance staff responsible for compounding compliance programmes.
Hospital pharmacy directors overseeing cleanroom operations and hazardous drug handling.
Pharmacy inspectors and auditors assessing compounding facilities against USP standards.
Pharmacy technicians pursuing sterile compounding competency assessment requirements.
Facilities and engineering staff supporting cleanroom design and environmental controls.
Course Modules
Select any module to see its sessions and points.
01Compounding Practice Foundations and Standards
2 sessions · 8 points
Session 1Non-Sterile Compounding Under USP <795>
- Classify a compounded preparation's complexity level under USP <795> risk categories.
- Select appropriate equipment and technique for a non-sterile compounding procedure.
- Document ingredient verification and calculation checks required for a non-sterile preparation.
- Apply quality control checks that confirm a non-sterile compound meets its intended specification.
Session 2Sterile Compounding Requirements Under USP <797>
- Distinguish USP <797> risk levels and the facility requirements each level demands.
- Apply garbing, hand hygiene and aseptic technique steps required before sterile compounding.
- Set primary and secondary engineering control requirements for sterile preparation areas.
- Determine which sterile preparations require additional testing before patient administration.
02Aseptic Technique and Cleanroom Operations
2 sessions · 8 points
Session 1Cleanroom Design, Classification and Environmental Monitoring
- Assess cleanroom classification requirements against the type of sterile compounding performed.
- Design an environmental monitoring programme covering air, surface and personnel sampling.
- Interpret monitoring results to determine whether a cleanroom remains within acceptable limits.
- Plan corrective action when environmental monitoring results exceed action levels.
Session 2Aseptic Technique and Personnel Competency Assessment
- Assess personnel aseptic technique using media-fill testing and direct observation.
- Set a competency assessment schedule appropriate to each compounding risk level.
- Identify common aseptic technique errors that increase contamination risk during compounding.
- Document competency assessment outcomes in a form that supports inspection readiness.
03Hazardous Drug Handling and Beyond-Use Dating
2 sessions · 8 points
Session 1Hazardous Drug Handling Under USP <800>
- Identify hazardous drugs requiring USP <800> handling, containment and disposal controls.
- Set personal protective equipment requirements appropriate to a hazardous drug compounding task.
- Design a containment strategy for receiving, storing and compounding hazardous drugs safely.
- Plan spill response and medical surveillance procedures for hazardous drug handling personnel.
Session 2Beyond-Use Dating and Stability Determination
- Determine a beyond-use date using default limits or supporting stability data.
- Assess when additional stability testing is required to extend a beyond-use date.
- Apply storage and packaging conditions consistent with the assigned beyond-use date.
- Communicate beyond-use dating limitations clearly on compounded preparation labels.
04Compounding Quality Assurance and Compliance
2 sessions · 8 points
Session 1Master Formulation Records and Batch Documentation
- Build a master formulation record that specifies ingredients, equipment and process steps.
- Complete batch documentation that allows a compounded preparation to be traced and verified.
- Review batch records for completeness and accuracy before a preparation is released.
- Maintain compounding logs that support recall investigation if a problem is identified later.
Session 2Quality Assurance, Inspection Readiness and Error Investigation
- Run a quality assurance programme that audits compounding practice against written procedures.
- Prepare a compounding facility and its documentation for a regulatory or accreditation inspection.
- Investigate a compounding error to identify its cause and the corrective action required.
- Report compounding quality metrics to pharmacy leadership on a regular monitoring cycle.
What the participant receives
4 course modules
A structured syllabus
8 training sessions
across 5 days
32 detailed points
Applied, detailed content
Accredited attendance certificate
On completing the programme
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