Protocol Control Number
PHA212G#P#
MASTER FORMULATION RECORD
PREPARATION
Official or Assigned Name Strength: Dosage Form:
Container Used (size and type): Route of Beyond Use Date
Administration: (BUD):
FORMULA
Component Original Computed Physical Description
Quantity Quantity
ADDITIONAL INFORMATION ABOUT THE INGREDIENTS:
Include any additional pertinent information about the ingredients required for compounding.
Indicate any specific precautions taken when handling the ingredients.
NOTES ON CALCULATIONS AND MEASUREMENTS:
Indicate any characteristics of the calculations, measurements or ingredient preparation that were done
COMPOUNDING
before the specific procedure was carried out.
Indicate any requirement for verification by the pharmacist.
Examples:
- Quality control of devices to be carried out and documented before measurements are taken.
- Accuracy of measurement devices.
- Verification and documentation of ingredients, batch numbers and beyond-use dates.
- Type of report required on the compounding form.
Note: Just indicate the computation made to get the computed quantity of the ingredients in the
formulation.
REQUIRED EQUIPMENT, APPARATUS AND MATERIALS
Indicate all materials and equipment that were required to compound the non-sterile preparations.
Equipment
1.
2.
Apparatus
1.
2.
Materials
1.
2.
COMPOUNDING METHOD
Describe all steps of the non-sterile-product compounding process.
Note: Must be numbered and not in paragraph form.
1.
QUALITY CONTROLS
Specify all quality control procedures that were carried out during compounding and documented by
the pharmacy technician and/or pharmacist. Specify all quality controls were carried out by the
pharmacist on the final compounded non-sterile preparation. Indicate the expected specifications.
Quality Control Expected Specifications
Appearance of the preparation - Liquid
- Colorless
- Pungent Odor
Weight/Volume of the
STABILITY
preparation
LABELLING INFORMATION
Indicate mandatory information that must be on the label of the compounded non-sterile preparation
Diluted Acetic Acid, USP Strength:
Ingredients
Acetic Acid……………………………………………..
Purified Water………………………………………..
Beyond Use Date: 14 days
- Warnings: Avoid contact with skin and eyes. Do not breathe product mists if formed.
Storage: Preserve in tight containers. Store away from moisture, isocyanates and
oxidizing agents. Do not allow product to become contaminated with other materials.
PATIENT COUNSELING
Counseling points to consider are the following: proper use, storage, handling, and disposal of the
preparation. Include instruction on ADR reporting and physical incompatibilities reporting.
- Keep containers closed during storage. Store away from moisture, isocyanates and
ADDITIONALoxidizing
INFORMATION
agents.
- Do not use in the eyes, swallow, inject, or inhale the medication.
- To avoid contamination, do not touch the dropper tip or let it touch your ear or any other
surface.
REFERENCES
Please follow APA, 6th edition.
USP. (n.d.). Retrieved from https://online.uspnf.com/uspnf/document/1_GUID-465A06DD-
75C4-4943-B5BB-636A7B6703B2_3_en-US?source=Activity
Preparation data sheet history No.:
Drafted by: Date:
Revised by: Date:
Change/s made: Version number changed:
_____ NO
_____ YES
