Compounding Documentation

Introduction

Good Compounding Practice, 2018 stipulates that compounding documents should include

• Master formulas
• Compounding records
• Standard operating procedures (SOPs) and related records
• Records such as the Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS) for all ingredients

According to Good Compounding Practice, 2018, all records and reports should be retained for 1 year after the beyond-use date, in accordance with relevant laws.

• Prescription for compounded poisons intended for individual patients must be retained for at least 2 years.
• During the retention period, all records and reports must be readily available for authorized inspection.

NOTE: Pharmaceutical Compounding and Dispensing, 2010 suggests that extemporaneous record sheets should be kept for a minimum of two years, although ideally five years would be advisable.

Master Formula

The master formulation record (or master formula) serves as the recipe for compounding a preparation, outlining the required procedures (i.e. what you should do).

This record shall include

• Official or assigned name, strength, and dosage form
• Calculations and doses
• Ingredients and quantities
• Compatibility and stability information and references
• Equipment needed
• Mixing instructions
• Label information
• Container used
• Packaging and storage requirements
• Description of the final preparation
• Quality control procedures and expected results

Compounding Records

The compounding record is the log book of all products made at the pharmacy (i.e. what you did).

• The compounding record must be sufficiently detailed enough to allow another trained individual to replicate the preparation steps, evaluate the correctness of the procedure and trace the origin of all components.

Compounding records should include

• Official or assigned name, strength and dosage
• Reference to master formulation record
• Names and quantities of all components
• Sources, lots numbers and expiration dates of components
• Total quantity compounded
• Names or persons who prepared, performed quality control and approved the preparation
• Date of preparation
• Reference to prescription or order
• Assigned beyond-use date
• Copy of label
• Stock card for each compounded preparation with the quantity of stock received and balance stock
• Description of final preparation
• Results of quality control (such as the weight of capsule or pH of the liquid)
• Documentation of any quality control issues and any adverse drug reactions reported by the patient
• Any other relevant documentation as required by the law

Standard Operating Procedures (SOPs)

All significant procedures performed in the compounding area should be addressed by written standard operating procedures (SOPs).

• Procedures should be developed for the facility, equipment, personnel, preparation, packaging, and storage of compounded preparations to ensure accountability, accuracy, quality, safety and uniformity in compounding.