What goes in a master formulation record

By Dumitru Musteata, RPh, Pharmacy Compounding Compliance. Last reviewed October 1, 2026.

This guide is independent commentary. It has not been reviewed, approved or endorsed by NAPRA or by any pharmacy regulatory authority, and the interpretations in it are the author’s own, not NAPRA’s. Your provincial or territorial regulator sets the requirements that apply to your pharmacy. They may or may not be based on NAPRA’s model documents and can differ between provinces, so always check your regulator’s current documents.

A master formulation record is the pharmacy’s approved recipe for a compounded preparation. It holds everything a trained person needs to make the preparation the same way every time, and the evidence behind the choices in it.

What the standards require

Under the Model Standards for Pharmacy Compounding of Non-Sterile Preparations, a master formulation record:

• must be developed for each non-sterile compound, by regulated pharmacy personnel with adequate experience and broad scientific knowledge;
• must include all the information necessary to compound the preparation;
• must contain supporting rationale and references;
• must be kept in a format that is readily accessible to compounding personnel.

The content list

Section 6.2 of the guidance document lists what the record should include:

• Official or assigned name, strength and dosage form of the preparation
• Expected yield
• Calculations needed to determine and verify the quantities of ingredients and the doses of active ingredients
• A description of all ingredients, with their quantities, sources and lot numbers where applicable
• Compatibility and stability data, with references when available
• References used to develop the formula, and the date they were consulted
• Equipment needed, and any special cleaning instructions
• Special precautions for compounding personnel, including personal protective equipment
• The source or origin of the formula
• Mixing instructions: order of mixing, temperatures or other environmental controls, duration of mixing, and anything else needed to replicate the preparation
• Sample labelling information: in addition to what the law requires, the generic name and quantity or concentration of each active ingredient, the assigned beyond-use date, storage conditions, and the prescription or control number
• The type of container used in dispensing
• Packaging and storage requirements
• A description of the final preparation
• Quality control procedures and expected results

The guidance document also provides a template with a header for the protocol number and version, the effective date, and who developed and who verified the record. NAPRA publishes it as a fillable form.

Where the risk assessment fits

The standards tie the two documents together. The rationale for the risk assessment and its mitigation, and the procedures for mitigating risk, must be documented on the master formulation record. They must be referenced, clear to everyone, and reviewed at least every 12 months. In practice the record should carry the level of requirements, the protective equipment, any containment or ventilation needed and any special handling steps for that preparation. How to document the risk assessment

Beyond-use dates

A beyond-use date must be assigned after consulting the manufacturer’s documentation and the literature on the stability, compatibility and degradation of the ingredients, and it should be assigned conservatively. The expiry date of a manufactured product used as an ingredient should not be used as the beyond-use date of the final preparation.

Where there is no stability information that applies to the specific preparation, the guidance document gives these maximums for preparations packaged in air-tight, light-resistant containers and stored at controlled room temperature unless otherwise indicated:

• Non-aqueous formulations: not later than the earliest expiry date of any active ingredient, or 6 months, whichever is earlier.
• Water-containing oral formulations: not later than 14 days, stored at controlled cold temperatures.
• Water-containing topical, dermal and mucosal liquid and semi-solid formulations: not later than 30 days.

In every case the beyond-use date cannot be later than the expiry date of any component. A longer date needs stability information for that formulation, and the record should name the reference. The factors to weigh include the nature of the ingredient, the compounding method, degradation mechanisms, compatibility, the dosage form, the potential for microbial growth, the container, the expected storage conditions and the intended duration of therapy.

Master formulation record or compounding record?

They are different documents. The master formulation record is written once per preparation and revised when something changes. The compounding record is completed every time the preparation is made, for an individual prescription or a batch. According to section 6.4 of the guidance document, the compounding record should contain:

• The official or assigned name, strength and dosage of the preparation, and a reference to its master formulation record
• The names and quantities of all ingredients, with their sources, lot numbers and expiry dates
• The total quantity compounded
• The names of the person who prepared it, the person who performed the quality control procedures and the person who approved it
• The date of preparation, and the assigned batch number or prescription number
• The assigned beyond-use date
• The results of quality control procedures, such as the weight range of filled capsules or the pH of an aqueous liquid
• Any quality control issues, and any adverse reactions or problems reported by the patient or caregiver

Keeping the record current

A master formulation record is not finished when it is signed. Changes should be supported by rationale and references, and compounding personnel must be told about them. The example quality assurance program in the guidance document checks master formulation records yearly, or when new information becomes available. The risk rationale on the record follows the 12-month review of the risk assessment.

A short self-check

1. Does the beyond-use date name the stability reference or the default rule it relies on?
2. Are the calculations shown, not only the final quantities?
3. Does each quality control have an expected result, such as appearance, weight range or pH?
4. Does the method match your equipment and batch size, or is it a supplier’s formula left unchanged?
5. Are the level of requirements and the protective equipment from the risk assessment on the record?
6. Is there a version number, an effective date, and the names of the people who developed and verified it?

Sources

• Model Standards for Pharmacy Compounding of Non-Sterile Preparations (NAPRA), sections 4 and 6
• Guidance Document for Pharmacy Compounding of Non-Sterile Preparations (NAPRA), sections 6.1, 6.2, 6.4 and 7.6
• Non-Sterile Preparations Assessment Criteria (Ontario College of Pharmacists), section 6

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