[PHARMACY NAME] Daily Refrigerator Temperature Log. Month/Year: Acceptable Temperature Range:

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1 [PHARMAC AME] Daily Refrigerator Temperature Log Month/ear: Acceptable Temperature Range: Checker Temperature Within acceptable range? (Please circle) Out of range temperatures corrected (Please check)

2 [PHARMAC AME] Daily Freezer Temperature Log Month/ear: Acceptable Temperature Range: Checker Temperature Within acceptable range? (Please circle) Out of range temperatures corrected (Please check)

3 [PHARMAC AME] Compounding Area/Storage Area Environmental Condition log Month/ear: Checker Temperature Moisture Ventilation

4 [PHARMAC AME] Expired Chemical and Product Disposal Log Product/ Chemical Manufacturer DC number Lot Quantity disposed Method of Disposal Checker

5 Store Training Documentation Sample: [Change if store s training is different] PHARMAC S AME/LOGO HERE 2015 USP <795> - onsterile Compounding Training Documentation Form Compounding Personnel: Compounder: Department: Job Title: Manager/Supervisor: Start of Training: End of Training: ote: of preceptor(s)/compounder(s) in area denotes competency In the Measurement Tools section, please review & confirm the method used to verify competency before initialing: V=Verbalized R=Reviewed D=Demonstrated P=Passed F=Failed Criteria General Training and Assessments 1. Read and review USP 795 and other applicable chapters Competency Verification Evaluator s/compounder s 2. Read and Review onsterile Policies and Procedures and Quality Assurance 3. onsterile Disposal 4. Beyond Use Dating 5. Antineoplastic Disposal 6. Storage and Handling Direct Preparation Training 1. Weighing and measuring of ingredients 2. Comminution 3. Blending 4. Trituration 5. Geometric Dilution 6. Levigation 7. Master Formulation Record Documentation 8. Compounding Record Documentation External Seminars ot Required 1. ational Seminars (A: Attended; P: Presented) 2. Local Seminars (A: Attended; P: Presented)

6 Master formulation record example: [Change if store s documentation forms are different] PHARMAC MASTER FORMULATIO RECORD Master Formulation Reference umber: XX- XX- XX Created: MM/DD/ Drug ame Concentration Final Quantity Calculations Performed Ingredients Description of Ingredient Compatibility/Stability Quantity Used Expected Preparation Description: Equipment eeded: Cleaning Procedure 1. Equipment Standard Operating Procedure, TBD, should be followed for cleaning equipment. 2. Facility Standard Operating Procedure, TBD, should be followed for cleaning nonsterile compounding area. Compounding Procedure 3. Clean compounding area and ensure equipment has been appropriately cleaned before compounding. 4. Compound product. 5. Label and dispense to patient. 6. Clean compounding area and ensure equipment is appropriately cleaned and stored. SpecialLabeling For Oral use OL Shake Well Required Container Plastic Amber Bottle Storage Expiration Beyond Use XX to XX C XX Days MM/DD/

7 Description of Final Preparation: Quality Control Procedure Sample Label Verification Made By Check 1 (PRE) Check 2 (POST)

8 Compounding record example: [Change if store s documentation forms are different] PHARMAC COMPOUDIG RECORD Master Formulation Reference umber: XX- XX- XX Prepared: MM/DD/ Drug ame Concentration Total Quantity Prepared Control umber/rx umber Ingredients Quantity eeded Quantity Used Manufacturer Lot umber Expiration Cleaning Procedure 1. Equipment Standard Operating Procedure, TBD, shall be followed for cleaning equipment 2. Facility Standard Operating Procedure, TBD, shall be followed for cleaning the facility. Compounding Procedure 1. Calibrate an appropriate size amber Rx bottle by measuring 60 ml water in graduated cylinder, add to bottle, mark the meniscus with black Sharpie marker 2. Measure 30 ml Ora- Plus in graduated cylinder 3. Triturate tablets to a fine powder in a glass mortar and pestle 4. Levigate with a small amount of Ora- Plus to form a paste 5. Add Ora- Plus via geometric dilution while mixing thoroughly 6. Transfer contents of the mortar to the calibrated amber Rx bottle 7. Rinse the mortar and pestle with Ora- Sweet and add to the amber Rx bottle 8. Quantum sufficit(qs) to 60 ml with Ora- Sweet 9. Shake well to mix thoroughly SpecialLabeling For Oral use OL Shake Well Required Container Plastic Amber Bottle Storage Expiration Beyond Use XX- XX C XX Days MM/DD/

9 Description of Final Preparation: Quality Control Sample Label Verification Made By Check 1 (PRE) Check 2 (POST)