13 Master Formulation Records

MASTER FORMULATION RECORDS

A Master Formulation Record (MFR) is a written document that includes all the information required to compound a preparation consistently and accurately. It serves as the official source document for preparing a compounded medication and ensures consistency, quality, and safety in every batch. It’s not patient-specific — instead, it’s the template used to create individual Compounding Records each time the compound is prepared.

Master formulation records (MFRs) must be accurate and complete to prevent drug errors. The development of new MFRs must be based on scientific data using appropriate references. There are many different references that can be used.  There is a chapter in this book on common references used in compounding:

References Used in Non- Sterile Compounding

You must create a new MFR when:

• No existing, validated MFR is available from a reliable source (e.g., Professional Compounding Centers of America (PCCA), hospital pharmacy, peer-reviewed journal).

• The existing formulation needs adaptation (e.g., different strength, ingredient substitution, change in dosage form).

• You are developing a unique preparation for a patient due to:

  • Allergies or sensitivities to commercially available products

  • Required changes in concentration, dosage form, or flavor

  • Lack of availability of a suitable manufactured product

• The regulatory body requires a locally generated MFR (check your province’s expectations).

• You are making a compound for the first time at your site and there is no MFR on file.

Before you begin, a risk assessment should be done to see whether it would be appropriate for this compound to be safely made at your pharmacy.  We will go over this in more detail in future chapters. You should be using the risk assessment form as guided by your provincial regulatory body. Here is a sample of Saskatchewan’s template:

SCPP Compounding Risk Assessment

 You also need to determine if this activity would constitute compounding or manufacturing, as per Health Canada’s Policy on Manufacturing and Compounding Drug Products in Canada.

Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051)

We will also cover this in more details in future chapters.

Here is a Master Formulation Record template from Saskatchewan College of Pharmacy Professionals:

SCPP Master Formulation Record Template

Creating a Master Formulation Record (MFR) for a non-sterile compound requires careful planning and documentation to ensure accuracy, consistency, and compliance with regulatory standards. Here is a step-by-step guide:

1. Identify the Need for Compounding

• Confirm that the compounded product is necessary due to the unavailability of a commercially manufactured equivalent.
• Ensure the formulation aligns with patient-specific needs (e.g., allergy-friendly, dosage adjustments).

2. Research and Gather Information

• Reference Reputable Sources: Use recognized compounding references such as the NAPRA Guidelines USP <795> (Pharmaceutical Compounding – Non-Sterile Preparations), Compendium of Pharmaceuticals and Specialties (CPS), or peer-reviewed literature.
• Check Stability & Compatibility: Investigate the stability, solubility, pH, and compatibility of ingredients.

3. List the Components

• Active pharmaceutical ingredient (API)
• Excipients (e.g., fillers, binders, flavoring agents, preservatives)
• Approved sources for each ingredient

4. Outline the Compounding Procedure

• Step-by-step instructions for preparation
  • order of mixing
  • duration of mixing
  • description of end point (e.g., levigate to a smooth paste)
• Specific equipment required (e.g., mortar & pestle, balance, mixer)
• Weighing and measuring guidelines
• Mixing techniques (e.g., trituration, levigation)
• Packaging and labeling requirements

5. Define Quality Control (QC) Measures

• Required physical checks (appearance, color, consistency)
• pH testing, if applicable
• Uniformity assessment (ensuring even distribution of active ingredients)
• Beyond-use dating (BUD) following USP <795> guidelines

6. Assign Beyond-Use Date (BUD)

• Based on NAPRA guidelines and USP <795> standards:
  • Non-aqueous formulations: up to 6 months
  • Water-containing oral formulations: up to 14 days (refrigerated)
  • Water-containing topical formulations: up to 30 days
• If stability data is available, adjust accordingly.

7. Include Safety & Hazard Considerations

• PPE (personal protective equipment) needed for handling ingredients
• Storage requirements (e.g., refrigeration, light protection)
• Disposal instructions for hazardous substances

8. Provide Documentation Requirements **A sample label may be required**

• Prescription details
• Lot numbers & expiry dates of ingredients
• Technician and pharmacist verification signatures
• Final product evaluation (weight/volume verification, labeling check)

9. Create the Label for Dispensing

• Name and strength of the compound
• Beyond-use date (BUD)
• Storage conditions
• Usage directions and warnings

10. Maintain the Record

• Keep the Master Formulation Record (MFR) on file
• Document each batch in a Compounding Log
• Review and update the record regularly for compliance and accuracy

MFRs must be:

• Readily accessible to compounding personnel.
• Organized in a central location—either:
  • Hard copy format (e.g., binder organized by dosage form or alphabetical order), or
  • Electronic format, with access controls and backup procedures in place.
• Kept up to date—you must review MFRs periodically and revise them when:
  • New stability or safety data becomes available
  • There are changes to procedures, equipment, or ingredients
• Archived properly—ensure outdated versions are clearly marked as “superseded” but retained for reference and compliance purposes (if required).
• Documented with version control—include:
  • Creation date
  • Author
  • References used
  • Revision history (with rationale for any changes)

More often than not, there are existing Master Formulation Records from reputable sources that can be used.  As long as the source you are getting the MFR from is reliable and the records are kept up to date, you may use this to guide you in creating the MFR for your pharmacy, rather than starting from scratch.

Here are some examples of websites that have existing Formulas for Compounding:

•  PCCA Compounding Formula Database – * – > 8,000 proprietary formulas
•  International Journal of Pharmaceutical Compounding (IJPC) (CompoundingToday.com) – *
•  The Hospital for Sick Children Compounding Service (Toronto) – Free
•  Izaak Walton Kilam (IWK) Health Centre/Dalhousie College of Pharmacy Drug Information Resources – Free
•  Children’s Hospital of Eastern Ontario (CHEO) – Free
•  Nationwide Children’s Compounding Formulas – Free

* Cost associated

The development of a Master Formulation Record is a structured and evidence-driven process that supports the safety, accuracy, and consistency of compounded medications. By using reliable references, following regulatory standards, and incorporating clear documentation and quality checks, pharmacy professionals can ensure that each preparation meets patient needs and professional expectations. While creating a new MFR from scratch may be necessary in some cases, using up-to-date and reputable existing formulations can often streamline the process.