# Pediatric Oral Suspension Compounding Log | Document ID | FRM-COMP-001 | |-------------|--------------| | Title | Oral Suspension Compounding Log | | Revision | 1.0 | | Effective Date | [DATE] | --- ## Patient/Prescription Information | Field | Value | |-------|-------| | Patient Name | ________________________________ | | Date of Birth | ________________________________ | | Prescription Number | ________________________________ | | Prescriber | ________________________________ | | Date Compounded | ________________________________ | ## Formulation Information | Field | Value | |-------|-------| | Medication | ________________________________ | | Final Concentration | _________ mg/mL (or mcg/mL) | | Total Volume | _________ mL | | Flavor | _________ ☐ None | | Beyond-Use Date (BUD) | ________________________________ | | Storage Requirements | ☐ Refrigerate (2-8°C) ☐ Room temperature ☐ Protect from light | ## Calculations ### Dosage Form Used ☐ Tablets ☐ Capsules ☐ Bulk powder **Product Details:** - Manufacturer: _______________________ - Strength: _________ mg per tablet/capsule - NDC: _______________________ - Lot Number: _______________________ - Expiration Date: _______________________ ### Quantity Calculation **Quantity Needed:** ``` Desired concentration: _______ mg/mL Final volume needed: _______ mL Total drug needed: _______ mL × _______ mg/mL = _______ mg total ``` **Dosage Forms Required:** ``` _______ mg total ÷ _______ mg per unit = _______ units Round up to: _______ tablets/capsules (includes overage: ______ %) ``` **Verified by:** _________________ (Second pharmacist initials) ## Ingredients | Ingredient | Manufacturer/Brand | Lot Number | Expiration Date | Quantity Used | |------------|-------------------|------------|-----------------|---------------| | [Drug name] | _______________ | __________ | ______________ | ______ units | | Suspending vehicle | _______________ | __________ | ______________ | ______ mL | | Sweetening agent | _______________ | __________ | ______________ | ______ mL | | Flavoring (if used) | _______________ | __________ | ______________ | ______ mL | | Other: __________ | _______________ | __________ | ______________ | __________ | ## Compounding Procedure ### Preparation Checklist ☐ Hand hygiene performed ☐ Appropriate garbing (lab coat, gloves) ☐ Work area cleaned and disinfected ☐ Equipment cleaned and ready ☐ All ingredients verified and gathered ### Compounding Steps Completed ☐ **Step 1:** Counted and verified ______ tablets/capsules ☐ **Step 2:** Crushed tablets to fine powder / Emptied capsule contents ☐ **Step 3:** Triturated to uniform powder ☐ **Step 4:** Added small portion of vehicle, mixed to smooth paste ☐ **Step 5:** Used geometric dilution, added vehicle in portions ☐ **Step 6:** Transferred to graduated cylinder ☐ **Step 7:** Rinsed mortar with vehicle ☐ **Step 8:** Brought to final volume: _______ mL ☐ **Step 9:** Added flavor (if applicable): _______ mL ☐ **Step 10:** Transferred to final container ☐ **Step 11:** Shook thoroughly for 30 seconds ## Quality Control ### Visual Inspection ☐ Uniform suspension (no large particles) ☐ Appropriate color ☐ Smooth consistency ☐ No visible contamination ☐ Suspends well when shaken ### Volume Verification - Target volume: _______ mL - Actual volume: _______ mL - Within acceptable range (±5%): ☐ Yes ☐ No ### Concentration Verification ``` Total drug: _______ mg Final volume: _______ mL Concentration: _______ mg ÷ _______ mL = _______ mg/mL ``` ☐ Matches intended concentration **Independent calculation by:** _________________ (Pharmacist initials) ## Beyond-Use Date Determination **Stability Reference:** ☐ Published study (citation): _________________________________ ☐ USP <795> general guidance: 14 days refrigerated / 30 days room temp ☐ Manufacturer information ☐ Trissel's Stability Reference ☐ Other: _________________________________ **BUD Assigned:** _________________________________ **Rationale:** ___________________________________________________ ## Labeling ☐ Patient name and date of birth ☐ Medication name and concentration ☐ "SHAKE WELL BEFORE EACH USE" ☐ Directions for use ☐ Beyond-use date ☐ Storage instructions ☐ "For Oral Use Only" ☐ Flavor (if added) ☐ Pharmacist initials ☐ Compounding date ☐ Auxiliary labels (if applicable) **Oral syringe provided:** ☐ Yes (size: _____ mL) ☐ No ☐ N/A ## Final Verification ### Pharmacist Final Check ☐ Correct medication and strength ☐ Accurate calculations verified ☐ Appropriate concentration for patient ☐ Correct labeling ☐ BUD appropriate and documented ☐ Storage instructions clear ☐ Quality checks passed **Verifying Pharmacist:** - Name: _________________________ - License #: _________________________ - Signature: _________________________ - Date/Time: _________________________ ## Counseling Points Provided ☐ Shake well before each use ☐ Use oral syringe for accurate dosing ☐ Storage requirements explained ☐ Beyond-use date explained ☐ Administration technique demonstrated ☐ Side effects discussed ☐ Importance of completing therapy **Counseled by:** __________________ Date/Time: __________ ## Documentation ### Compounded by - Technician/Pharmacist Name: _________________________ - Signature: _________________________ - Date/Time: _________________________ ### Checked by - Pharmacist Name: _________________________ - License #: _________________________ - Signature: _________________________ - Date/Time: _________________________ ## Cleanup ☐ All equipment washed and dried ☐ Work surface disinfected ☐ Waste disposed of appropriately ☐ Ingredients returned to storage **Cleaned by:** __________________ Date/Time: __________ ## Notes/Deviations _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ --- ## For Pharmacy Records **Record Retention:** Per state board requirements (minimum 3 years) **Filed in:** ☐ Compounding logs ☐ Patient profile ☐ Both **Log reviewed by:** ______________ Date: ________ --- *Form FRM-COMP-001 Rev 1.0 - Pediatric Pharmacy Compounding*