United States
Hong KongMaster formulation record for nonsterile compounding
Under USP General Chapter <795>, the Master Formulation Record (MFR) is the planned, reusable instruction set for a particular compounded nonsterile preparation.
More key points
- The Compounding Record documents what actually happened for a specific preparation.
- The MFR supports repeatability; the individual record provides traceability and evidence of the completed work.
On this page5 sections
A pharmacy compounding a nonsterile preparation needs more than a handwritten recipe that happens to work once. USP General Chapter <795> uses two related records: a Master Formulation Record (MFR) that describes the intended formulation and process, and a Compounding Record that captures the details of an actual preparation. One is the controlled plan; the other is the event-specific evidence.
What belongs in the Master Formulation Record
The MFR is established for the formulation before the preparation is compounded. It identifies the preparation by its official or assigned name, strength or activity, and dosage form. It records the identity and quantity of ingredients, calculations needed to determine and verify component amounts or final strength, and information needed to reproduce the method consistently.
The process description should be detailed enough to guide another qualified compounder. Depending on the preparation, it addresses equipment, the order of mixing, mixing time and temperature or other controls, packaging and container, storage, and the expected physical description of the final product. The record also supports the assigned beyond-use date (BUD) and storage conditions with an appropriate source, and specifies labeling and quality-control checks with expected results. Compatibility and stability information should be included, with references where available.
A materially different strength, dosage form, ingredient set, or process may require its own MFR or an approved revision. Do not assume that scaling one recipe automatically validates every batch size or formulation.
What the Compounding Record adds
The Compounding Record is prepared for each compounded preparation. It points back to the MFR and records the actual date, quantity, and component details for that preparation, including identifying information such as component sources, lot numbers, and expiration dates. It identifies the people involved in compounding, checking quality, and approving the preparation as applicable. It records the assigned BUD, final preparation description, labeling, and actual quality-control results, along with deviations or quality problems that require documentation.
| Question | Master Formulation Record | Compounding Record |
|---|---|---|
| Purpose | Defines the approved formulation and reproducible procedure. | Documents one actual compounding event. |
| When created | Before compounding the formulation; revised when needed. | For each preparation or batch as required. |
| Typical details | Formula, calculations, equipment, instructions, packaging, storage, BUD basis, QC method and expected result. | Actual quantities and component lots, date, total made, responsible personnel, actual QC results, deviations. |
| Memory aid | The standard recipe and method. | The batch-specific production record. |
Example
A pharmacy has an approved MFR for a 2% topical preparation. The MFR specifies the ingredients, their quantities for the defined batch, calculation method, mixing order, packaging, storage, BUD basis, and appearance check. On Tuesday, a technician prepares a batch under supervision. The Compounding Record identifies the actual ingredient lots and measured amounts, who prepared and checked it, the batch quantity, assigned BUD, observed appearance, and any deviation. If the technician finds a mixing problem, the event belongs in the actual record and is investigated; it is not silently edited out of the reusable procedure.
Why two records matter
- Repeatability: a clear MFR lets trained personnel follow the same formulation and controls across preparations.
- Traceability: the Compounding Record links a specific preparation to its components and responsible personnel.
- Quality review: expected QC outcomes in the MFR can be compared with actual results in the Compounding Record.
- Investigation: a documented deviation or complaint can be connected to the formulation, process, materials, and preparation date.
- BUD and storage: the planned basis is documented in the formulation record and the assigned value is recorded for the individual preparation.
Common exam mix-ups
- Calling the MFR the record of what happened in a particular batch; that is the Compounding Record.
- Treating a formula alone as complete when process instructions, calculations, packaging, storage, BUD support, and QC are also important.
- Putting actual component lot numbers only in the reusable template instead of documenting them for the specific preparation.
- Assuming an MFR replaces a prescription or order, quality checks, proper labeling, or applicable state documentation rules.
- Applying sterile-compounding requirements from USP <797> when the question is specifically about a nonsterile preparation under <795>.
For the PTCE, remember the relationship: MFR = what should be made and how; Compounding Record = what was made, when, by whom, from which materials, and with what observed results. USP <795> is a professional standard, while state law and board rules can add requirements. Use the current official chapter and local rules for operational decisions.
Common questions
Is the Master Formulation Record written before or after compounding?
It is established before compounding the preparation so the process and checks are defined in advance.
Does each compound need a Compounding Record?
The Compounding Record documents the specific preparation; follow current USP <795> and applicable state rules for the required record and documentation.
Where are component lot numbers recorded?
The batch-specific Compounding Record captures identifying details of the actual components used, such as source, lot number, and expiration date.
Does an MFR assign the BUD?
The MFR supports the assigned BUD and storage instructions with an appropriate basis. The BUD for the individual preparation is also recorded in its Compounding Record and on required labeling.