pediatric-pharmacy/Forms/Compounding-Records/FRM-COMP-001-Oral-Suspension-Compounding-Log.md

Pediatric Oral Suspension Compounding Log

Document ID	FRM-COMP-001
Title	Oral Suspension Compounding Log
Revision	1.0
Effective Date	[DATE]

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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

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For Pharmacy Records

Record Retention: Per state board requirements (minimum 3 years)

Filed in: ☐ Compounding logs ☐ Patient profile ☐ Both

Log reviewed by: ______________ Date: ________

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Form FRM-COMP-001 Rev 1.0 - Pediatric Pharmacy Compounding