Master formulation records for compounding
A master formulation record for each preparation you compound, written from your formula by a pharmacist: ingredients, calculations, method, quality controls, packaging, storage and a beyond-use date with its references. Delivered in Word, usually within 30 days.
Why the record matters
The standards require a master formulation record for every non-sterile preparation, with supporting rationale and references, kept where compounding staff can reach it. It is also where the risk assessment’s mitigation steps are written down, which makes it the working document for anyone who compounds or verifies the preparation. A formula copied from a supplier rarely matches your equipment, your quantities or your beyond-use date.
What each record contains
Each record follows the content list in section 6.2 of the guidance document:
- Name, strength and dosage form of the preparation, and the expected yield
- Every ingredient with its quantity, description and source
- The calculations needed to determine and verify quantities
- Equipment required, with any special cleaning instructions
- The compounding method step by step: order of mixing, temperatures and mixing times
- Special precautions and personal protective equipment, taken from the risk assessment
- Quality control procedures and the expected results
- Container, packaging and storage requirements
- The beyond-use date, with the stability data or default rule it is based on
- Sample label information and a description of the finished preparation
- References consulted, with dates, and the source of the formula
- Who developed and who verified the record, with a version number and effective date
Beyond-use dates you can defend
Where there is no stability data for a formulation, the guidance document gives maximum beyond-use dates for preparations packaged in air-tight, light-resistant containers: 14 days under refrigeration for water-containing oral formulations, 30 days for water-containing topical, mucosal and semi-solid formulations, and the earliest ingredient expiry date or 6 months, whichever comes first, for non-aqueous formulations. The date is never later than the expiry date of any component, and a longer date needs stability information that applies to that formulation. Each record states which rule or reference its date comes from, so the supervisor can verify it.
How it works
- Send your list of preparations and the formulas as you make them now: ingredients, quantities, base, container and usual batch size.
- We confirm the count and send a fixed quote.
- We draft each record, checking the formula against stability and compatibility references and the safety data sheets.
- You review the drafts. One round of revisions is included if requested within 14 days of delivery.
- Your supervisor verifies, signs and dates each record.
Each set comes with a compounding record form, the log completed every time a batch is made, laid out to match the master formulation records.
Pair it with the risk assessment
A master formulation record and a risk assessment describe the same preparation from two sides, and the standards expect the risk mitigation steps to be written on the master formulation record. It makes sense to prepare both together for each preparation. About risk assessments
Common questions
How many records do we need?
One for each distinct preparation. A different strength, base or dosage form is a different record.
Can you start from our supplier’s formula?
Yes. Supplier formulas are a good starting point. The record still has to reflect your equipment, your batch size, your container and a beyond-use date you can support.
What if we change a formula later?
The record should change with it, with the reason and the references noted, and compounding staff must be told about the change. Updates after delivery are quoted separately.
Where can I see what a complete record looks like?
Our guide goes through every element: What goes in a master formulation record.