The Inspection Process For Pharmacies Compounding Sterile .
. . . generic name?BUD?“compounded by pharmacy,” if applicable?unique facility lot number, if compoundedas a batch?Are CSPs assigned a BUD based onlabeling for the drug, literature sources,and/or direct testing?Training and CompetencyHave all compounding personnel (pharmacist andpharmacy technician) completed the required educationand training? ACPE-accredited course or ASHP-approved programOn-the-job trainingIs there documentation of an initial competencyevaluation that includes . . . Observation?Media-fill testing?Gloved fingertip testing?Is there documentation of ongoing training and testing?15
10/28/2017Initial vs. Ongoing CompetencyInitial(prior to preparing CSPsfor patients)OngoingEducation20/40 hours of ACPEaccredited training2 or 4 hours of continuingeducation per renewalperiodObservationBy a trained compounderBy a trained compounderMedia-fill TestRepresenting the mostchallenging or complexpreparationRepresenting the mostchallenging or complexpreparationGloved Fingertip TestThumb and all fingers ofboth hands on 3 occasionsto demonstrate competenceat donning garb and sterileglovesThumb and all fingers ofboth hands after preparinga compound or completingmedia fill test todemonstrate aseptictechnique competencyExamples of Commonly Seen ViolationsTraining and Competency Lack of education/training documentation Improper initial gloved fingertip testing (not obtained priorto compounding and on 3 occasions)16
10/28/2017High-risk Sterile Preparations Does the buffer area provide physicalseparation?Is sterility testing performed if . . . CSPs are prepared in groups 25?MDVs are prepared for multiple patients orwhen exposed to 12 hrs at 2-8 degreesC?Exposed 6 hrs at 8 degrees C?High-risk Sterile Preparations Are CSPs . . . Pre-filtered using no larger than a 1.2 micronfilter?Filtered using a sterile 0.2 to 0.22 micrometerpore size filter in at least an ISO Class 5environment?Are filter integrity tests performed anddocumented?Are pre-sterilization procedures (weighingand mixing) completed in an ISO 8 or betterenvironment?17
10/28/2017Hazardous Sterile PreparationsDoes the pharmacy have . . . protective apparel?safety and containment techniques?appropriate waste disposal?appropriate labeling?pressure indicator to readily monitor roompressurization?Are hazardous drugs stored separately?Compounding for Office Use Does the pharmacy have a writtenagreement with the prescriber that meetsall requirements? If the pharmacy is distributing to anotherpharmacy, are the specified requirementsmet?18
10/28/2017You are the Compliance Inspector.What is the violation?You are the Compliance Inspector.What is the violation?19
10/28/2017You are the Compliance Inspector.What is the violation?Questions?20
10/28/2017 1 The Inspection Process for Pharmacies Compounding Sterile Preparations (CSPs) Timeline of the Regulation of CSPs in Texas 11/9/2013 1982 First mention of “IV Admixtures” in the Texas Pharmacy Act 1991 Requirements for the preparation of sterile ph
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