12 Chapter 12: Documentation of Compounding Activities

Requirements for Documentation in Canada for Non-Sterile Compounding

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.

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 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.

Insert template   https://saskpharm.ca/document/6879/CompEX_Template_Master_Formulation_Record_20210112.pdf

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. 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

3. Quality and Storage of Ingredients for Non-Sterile Compounding

Ensuring Purity and Safety

To maintain the integrity of compounded preparations, reasonable measures must be taken to verify the purity and safety of all ingredients. This can be achieved by analyzing batch data, confirming the reputation of the manufacturer, and ensuring the reliability of the supplier. Any ingredient requiring special handling or storage precautions should be properly identified. Ingredients and raw materials must be stored under conditions that preserve their quality and purity, as specified by the manufacturer or in accordance with recognized pharmacopeial monographs.

Selection of Ingredients

When choosing active or inactive ingredients for compounding, the following factors must be considered:

• • Physicochemical properties
  • Efficacy
  • Stability
  • Compatibility
  • Toxicity
  • Patient-specific considerations, including allergies and disease state
  • Prescriber’s therapeutic intent
  • Potential interactions
  • Treatment duration
  • Route and frequency of administration

For any formulation requiring water, only purified water (e.g., distilled or deionized water) or water of equivalent or superior quality (e.g., sterile irrigation water) must be used. Bottled water dispensers, whether programmed or unprogrammed, are not recommended due to insufficient data on water quality maintenance. Tap water is unsuitable for compounding and must not be used.

Sources of Ingredients

Compounding ingredients must be sourced from recognized and reputable suppliers. Non-sterile preparations should utilize approved ingredients that:

• • Have been assigned a Drug Identification Number (DIN) for use in Canada, or
  • Meet the standards outlined in pharmacopeial monographs from recognized sources such as the United States Pharmacopeia (USP), European Pharmacopoeia, British Pharmacopoeia, National Formulary of the United States, or Schedule B of the Food and Drugs Act.

When compendial-grade ingredients are unavailable, high-quality alternatives such as those listed in the Food Chemicals Codex, analytical reagent-grade substances, or materials certified by the American Chemical Society (ACS) may be used. However, caution must be exercised, as these materials are not assessed for safety in human or veterinary applications.

Quality Control of Ingredients

Only high-quality ingredients that meet identity and purity standards should be used in non-sterile compounding. Supporting documentation, such as Certificates of Analysis (COAs), should be obtained and retained. The pharmacy must keep detailed records of ingredient sources, including:

• • Lot numbers
  • Expiry dates
  • Date of receipt

If an ingredient is not sourced from a recognized supplier, it must be analyzed by a qualified laboratory to confirm its identity, purity, and compliance with pharmacopeial standards. Analytical results and supporting certificates should be documented in an ingredients log.

Ingredients that have been recalled or withdrawn from the market for safety reasons must not be used. Health Canada maintains an up-to-date list of recalled drugs on its website. If using ingredients derived from ruminant animals (e.g., bovine, caprine, ovine), the supplier must provide written confirmation of compliance with federal regulations governing their processing, use, and importation.

Storage and Handling of Ingredients

Ingredients should be stored in their original containers under appropriate conditions to prevent degradation. Key considerations include:

• • Limiting exposure to environmental factors that could impact stability.
  • Ensuring material withdrawals are conducted by trained personnel.
  • Properly labeling transferred ingredients with:
    • Name of the ingredient
    • Original supplier
    • Lot/control number
    • Date of transfer
    • Expiry date

For ingredients lacking a manufacturer-assigned expiry date, a conservative in-house expiry should be assigned, not exceeding three years from the date of receipt, based on the ingredient type, storage conditions, and container integrity. All ingredients must be inspected before use to detect any signs of deterioration.

Safety Data Sheets (SDS)

Suppliers must provide Safety Data Sheets (SDS), previously known as Material Safety Data Sheets (MSDS), as required by the Hazardous Products Act. These documents outline:

• • Risks associated with the ingredient
  • Preventative measures
  • Recommended storage conditions

SDS documents must be readily accessible to all personnel involved in non-sterile compounding. Pharmacies should maintain an updated collection of these documents and ensure they are reviewed regularly, as suppliers update them every three years.

4. Quality Assurance & Cleaning Logs

• • Documentation of equipment calibration and maintenance.
  • Cleaning logs for surfaces, utensils, and equipment.
  • Environmental monitoring logs (if applicable).

5. Personnel Training Records

• Compounding staff must receive proper training and their competency assessments must be documented.
• Records of ongoing education and training should be maintained.

6. Incident & Adverse Event Reports

• Any errors, deviations, or adverse reactions must be recorded and reviewed.
• Corrective actions should be documented to prevent recurrence.

Retention Period

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

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.