USP 795 Nonsterile Compounding Master Formulation Record

This template is used to create a master formulation record for a specific nonsterile compounded preparation under USP 795. It captures the minimum necessary details to compound the same preparation consistently, including ingredients, calculations, equipment, procedure, quality checks, and final product specifications. It is the reference document your team uses before making a batch, not the batch-specific log itself.

Create a new record whenever the formulation, strength, dosage form, process, equipment, packaging, or storage requirements change in a way that affects the final product. You should also update the record when a source reference changes or when review reveals a better way to document the process. If the preparation is materially different, reuse creates avoidable risk and weakens traceability.

It is typically prepared by the compounding pharmacist or another qualified team member and reviewed and approved by the pharmacist responsible for the preparation. The reviewer should confirm the formula, calculations, process steps, in-process checks, and labeling instructions are complete and internally consistent. The approval section should make clear who authorized use of the record and when.

Yes, it is structured to support the documentation expectations around nonsterile compounding by organizing the formula, references, calculations, equipment, process, and release criteria in one place. It helps show that the preparation was defined before compounding and that the team used a controlled, repeatable method. It is not a substitute for your pharmacy’s policies, training, or state-specific requirements.

Common mistakes include missing ingredient strengths, unclear calculation basis, vague procedure steps, and incomplete storage or beyond-use date instructions. Another frequent issue is leaving out in-process checks or special handling details, which can lead to inconsistent batches. This template also helps avoid approval gaps by making review and release fields explicit.

Yes, the template is meant to be cloned and adapted for each specific preparation. You can tailor the ingredient table, equipment list, procedure summary, packaging requirements, and labeling instructions to match the dosage form and compounding method. Keep the structure intact so the record remains easy to review and compare across formulations.

The master formulation record defines how the preparation should be made, while the batch record documents what was actually made on a specific date. Dispensing records then track the final supply to the patient or destination. Keeping these documents separate improves audit trail clarity and makes it easier to investigate deviations or complaints.

This record often feeds into pharmacy management systems, label generation, inventory tracking, and batch documentation workflows. If you use digital forms, plan for links to ingredient master data, calculation tools, and approval routing so the record can move from drafting to review without retyping. The key is preserving version control and a clear audit trail.

Start with your highest-volume or highest-risk nonsterile preparations and standardize those first. Have one pharmacist draft the record, another review it for clarity and safety, and then train staff on where to find the current version and how to flag discrepancies. A short pilot helps catch missing fields, unclear instructions, and local workflow issues before full adoption.