13 Chapter 13: 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 for each instance of preparation.
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. This is a sample list form Alberta College of Pharmacy: ACP Master Formulation Template
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:
Insert 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.
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’s a step-by-step guide:
- 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).
- 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.
- List the Components
- Active pharmaceutical ingredient (API)
- Excipients (e.g., fillers, binders, flavoring agents, preservatives)
- Approved sources for each ingredient
- Outline the Compounding Procedure
- Step-by-step instructions for preparation
- order of mixing
- duration of mixing
- description of end point (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
- 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
- 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.
- Include Safety & Hazard Considerations
- PPE (personal protective equipment) needed for handling ingredients
- Storage requirements (e.g., refrigeration, light protection)
- Disposal instructions for hazardous substances
- Provide Documentation Requirements **sample label only**
- Prescription details
- Lot numbers & expiry dates of ingredients
- Technician and pharmacist verification signatures
- Final product evaluation (weight/volume verification, labeling check)
- Create the Label for Dispensing
- Name and strength of the compound
- Beyond-use date (BUD)
- Storage conditions
- Usage directions and warnings
- 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
More often than not, there are existing Master Formulation Records that can be used. As long as the source you are getting the MFR from is reliable and keeps the records up to date, this is a better option than you creating a MFR 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
- 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
