"

15 Chapter 15: Compounding Records

As was discussed previously, a formulation record serves as a standardized recipe for preparing a non-sterile compound. It ensures consistency, accuracy, and safety every time a particular compound is prepared, regardless of who performs the compounding. The formulation record is a master reference and is not updated with batch-specific data. It must be reviewed and validated periodically.

A compound record documents the actual preparation of a non-sterile compound. It includes batch-specific details and must be maintained for every prescription or batch prepared, regardless of whether it is a single-patient prescription or a batch for stock.

NAPRA-Required Elements of a Compound Record:

  • Official or assigned name, strength, and dosage form
  • Reference to the Master Formulation Record
  • Names and quantities of all ingredients used
  • Sources, lot numbers, and expiry dates of ingredients
  • Total quantity compounded
    • Assigned prescription number or batch number

      Compound Yield:  Theoretical vs Actual

      Quality control
      Goal of 95-105%
  • Date of preparation
  • Assigned BUD
  • Name of person(s) involved in:
    • Preparing the compound
    • Performing quality control checks
    • Approving the final product
  • Results of quality control (QC) procedures, such as:
    • Weight range for filled capsules
    • pH measurements
    • Final volume/appearance checks
    • Yield
  • Any deviations from Master Formulation Record
  • Any observed problems, or adverse reactions reported
  • Rationale for compounding, when applicable (e.g., patient allergy, commercial shortage, swallowing difficulties)
  • Record of origin if the compound was made by another pharmacy (as permitted by provincial/territorial legislation)

Compound records can be paper-based or digital, and must be retained as required by the provincial/territorial pharmacy regulatory authority. For example, this may be 10 years or 2 years past the age of majority for pediatric patients.

 

 

 

 

**Need Example of a compound Record

 

 

 

Comparison Table: Formulation vs. Compound Record

 

 
Aspect Formulation Record Compound Record
Purpose Master recipe Real-time documentation of compounding
Timing Created in advance Created during/after compounding
Patient-specific info Not included Included if prepared for individual prescription
Staff signatures Not required Required for preparer, checker, approver
Ingredient lot tracking Not included Required
Quality control results General procedures Batch-specific results
BUD Assignment Included as reference Applied specifically to batch
Source Documentation Includes literature references May include rationale for compounding
Updates Reviewed periodically Created anew for each compound event

 

  

Recordkeeping for Compounded Preparations from Other Pharmacies

When dispensing a compound made by another pharmacy:

  • The origin pharmacy must be documented.
  • The dispensing pharmacy remains responsible for being able to track all preparations it dispenses.
  • This supports traceability, quality assurance, and regulatory compliance.

Batch Records

  • The compounding record for a batch, made in anticipation of a Rx
  • Usually filed by lot number
  • Traceable to each patient
  • Assign lot number based on date and compounder, e.g., DDMMYYYY-initial of compounder (04012021-JB)
  • Keep records for batched compound in log book or computer software

 

License

Icon for the Creative Commons Attribution-NonCommercial 4.0 International License

Pharmacy Non-Sterile Compounding in Canada Copyright © by Janet Hoda is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, except where otherwise noted.

Share This Book