12 Documentation of Compounding Activities

In Canada, non-sterile compounding in pharmacies must adhere to the National Association of Pharmacy Regulatory Authorities (NAPRA) Model Standards for Pharmacy Compounding of Non-Sterile Preparations. Proper documentation ensures traceability, quality control, and regulatory compliance.  Documentation must be maintained for every stage of the compounding process—from formulation development to personnel training—to support both patient safety and regulatory oversight. Whether using manual systems or pharmacy software, proper records enable consistent practices, facilitate quality assurance, and allow for effective review in the event of an error or inspection.

Key Documentation Requirements

1.  Master Formulation Record (MFR)

A Master Formulation Record includes all the necessary information to compound a product. It must be created for each compounded preparation and should include:

• • Name and strength and dosage form of the preparation
  • Active and inactive ingredients (with exact quantities and descriptions, compatibility and storage)
  • Calculations needed to determine and verify quantities needed
  • Compounding instructions (step-by-step process)
    • Order of mixing
    • Duration or endpoint of mixing
  • Equipment required, including personal protective equipment (PPE) and precautions required
  • Beyond-Use Date (BUD), packaging and storage requirements
  • Quality control measures
    • Expected yield
    • Description of final product
  • Reference sources for the formulation record and the date created
  • Sample label

An MFR must be kept up to date.  If changes are made, there should be a rationale and evidence based resources should be used. MFRs need to be kept together either in a hard copy, for example a binder, or electronically.

SCPP Master Formulation Record Template

2. Compounding Record (Preparation Record)

For every compounded product, either individual or batched preparations, a Compounding Record must be completed.   These must be retained for future reference as per provincial/territorial regulatory body. Compound records are normally done electronically in your pharmacy software, such as Kroll, but I have provided a sample to see below. The compound record must include:

• • Name, strength and dosage form of preparation
  • Date the compound was produced
  • Total quantity compounded
  • Batch number or transaction/prescription number
  • Names and quantities of ingredients used (including lot numbers and expiry dates)
  • Personnel involved in compounding and verification
  • Reference the Master Formulation Record and any deviations from the Master Formulation Record
  • Final verification and quality control results (appearance, weight, pH, etc.)
  • Assigned Beyond-Use Date (BUD)
  • Patient or prescription number (if applicable)
  • Documentation of any issues that arise with compound or patient

Compounding Record Template

3. Quality Assurance and Control Documentation

Quality Assurance and Control documentation is essential for maintaining the integrity and safety of compounded preparations. We will go over these in more detail in future chapters but they include:

• • Cleaning and maintenance logs for facilities and equipment
  • Calibration records for balances and other measuring devices
  • Environmental monitoring records (if required by risk level)

4. Policies and Procedures

Policies and Procedures documentation provides the framework for standardized compounding practices. These written guidelines ensure that all personnel follow consistent, safe, and compliant methods in every aspect of non-sterile compounding. We will discuss in future chapters but to summarize:

• • There must be written policies
  • They must be readily retrievable
  • They include policies on cleaning, risk assessment, and handling hazardous substances

5. Personnel Training Records

Proper documentation of personnel training is important to ensure that all compounding staff are qualified and up-to-date with current standards and procedures

• Compounding staff must receive proper training and their competency assessments must be documented.
• These records must include initial and ongoing competency assessments for all compounding personnel, detailing the specific training received, dates, and the names of both the trainee and the assessor.
• Documentation should also reflect participation in continuing education, updates on new procedures or regulations, and any remedial training undertaken.

6. Incident & Adverse Event Reports

Documenting incidents and adverse events is essential for identifying risks, improving processes, and ensuring patient safety in compounding practice

• These reports must capture details of any errors, deviations from standard procedures, contamination events, or adverse reactions associated with a compounded product.
• Each report should include a description of the event, date, personnel involved, and immediate actions taken.
• The documentation must also outline the root cause analysis and corrective actions implemented to prevent recurrence

SCPP Incident Report Template

7.  Risk Assessment

• Mandatory for Each Preparation: Every non-sterile compounded product must undergo a risk assessment covering both the risk to the preparation (e.g., contamination, stability) and risk to personnel (e.g., exposure to hazardous ingredients)
• Regular Review: Risk assessments must be reviewed at least annually, or sooner if there are changes in practice, standards, or the compounding environment
• Documentation: All findings and decisions from the risk assessment must be documented, including references such as Safety Data Sheets (SDS), Master Formulation Records, and relevant literature

Retention Period

Documentation should be retained for at least two years (or as required by provincial regulations).

By maintaining accurate, up-to-date, and retrievable documentation, pharmacies demonstrate their commitment to quality assurance, staff accountability, and regulatory compliance. In the event of a quality concern, proper records also provide a critical pathway to investigating and resolving issues efficiently. Proper documentation ensures patient safety, product consistency, and compliance with regulatory standards.  We will be going into further details of these documentation needs in later chapters.