USP 795 Compounding Record and Beyond-Use Dating
USP 795 compounding record template for documenting nonsterile preparations, traceability, in-process checks, and beyond-use dating in one place.
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Built for: Community Pharmacy · Hospital Pharmacy · Compounding Pharmacy
Overview
This template documents a single USP 795 nonsterile compounding event from start to finish. It captures the record identification, the prescription or order basis, the formulation reference, ingredient and equipment traceability, in-process checks, water activity details, the assigned beyond-use date, and the final release sign-off.
Use it when you need a repeatable record for compounded preparations where the BUD must be justified and reviewed, not guessed. The structure is useful for creams, ointments, suspensions, capsules, and other nonsterile dosage forms that require a clear audit trail. It also helps when multiple staff members touch the same preparation, because the preparer, checker, and reviewer each have a defined place in the record.
Do not use it as a generic intake form or for sterile compounding workflows. If your process does not rely on water activity, the BUD section should still show the basis used, but the water activity fields should not be forced into every case. The template is also not a substitute for your pharmacy’s SOPs, master formulation records, or local regulatory requirements. Its purpose is to make each compounding event easier to review, release, and defend during quality checks.
Standards & compliance context
- This template supports USP 795 documentation by capturing the formulation basis, process checks, and beyond-use dating rationale for nonsterile compounding.
- The record design aligns with data minimization by collecting only the fields needed to document the preparation, review, and release decision.
- If the form collects names or other PII, include a clear notice about who can access the record and how long it is retained.
- For any public-facing or shared form, ensure the fields, labels, and validation support WCAG 2.1 AA accessibility.
General regulatory context for orientation only — verify current requirements with counsel or the relevant agency before relying on this template for compliance.
What's inside this template
Record Identification
This section anchors the batch in time and assigns responsibility so the record can be traced back to the exact compounding event.
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Record Number
System-generated unique identifier for this compounding record.
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Compounding Date
Date the nonsterile compounding event was performed.
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Compounding Time
Time the compounding event was started or completed, as used by your facility’s recordkeeping process.
- Pharmacy or Facility Name
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Preparer Name
Name or identifier of the individual who prepared the compound. Collect only what is needed for the audit trail.
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Independent Checker / Reviewer
Name or identifier of the person who performed the independent review, if applicable.
Formulation and Prescription Basis
This section shows why the preparation was made and which master formulation or order governed the work.
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Prescription or Order Reference
Reference number or internal order identifier used to link this record to the source order.
- Dosage Form
- Compounding Basis
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Master Formulation Record Reference
Reference ID for the master formulation record, if used.
- Formulation Name
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Intended Use / Route
Optional route or intended use if needed for internal documentation.
Ingredients and Lot Traceability
This section preserves the ingredient and equipment trail needed to review quality, reproducibility, and potential sources of variation.
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Ingredients
List each ingredient used in the compound, including lot-level traceability and quantity used.
- Equipment Used
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Equipment Notes
Describe any additional equipment used that is not listed above.
Compounding Process and Quality Checks
This section captures what was done during preparation and whether any deviations or in-process issues affected the batch.
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Compounding Procedure Summary
Brief summary of the actual compounding steps performed. Include only the information needed for reproducibility and review.
- In-Process Checks Performed
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Check Notes
Record results of in-process checks, including any out-of-trend observations.
- Did any deviation occur?
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Deviation Description
Describe the deviation and any immediate containment or corrective action taken.
Water Activity and Beyond-Use Dating
This section documents the stability basis for the assigned BUD and the storage conditions that support it.
- Was Water Activity Measured?
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Water Activity Value (aw)
Enter the measured water activity value, if available.
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Water Activity Test Method
Identify the method or instrument used for water activity determination.
- Storage Condition
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Storage Notes
Describe any special storage requirements or exceptions.
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Assigned Beyond-Use Date
The final beyond-use date assigned according to the applicable USP 795 framework and internal policy.
- BUD Basis
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BUD Rationale
Document the basis for the assigned BUD, including any water activity, dosage form, storage condition, or stability considerations used in the decision.
Review, Release, and Sign-Off
This section confirms that the record was checked, approved, and released only after the preparation met your review criteria.
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Final Review Completed
Confirm that the record was reviewed for completeness and accuracy.
- Released for Use
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Release Notes
Explain why the compound was not released, if applicable.
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Reviewer Signature
Signature of the person performing final review or approval.
- Review Date
How to use this template
- Create a new record for each compounded preparation and enter the record number, date, time, pharmacy name, preparer, and checker before compounding begins.
- Link the form to the prescription or order reference, select the dosage form, and point to the master formulation record that governs the recipe.
- List every ingredient and lot number, note the equipment used, and record any equipment-specific observations that could affect the batch.
- Document the compounding steps and in-process checks as they happen, and describe any deviation with enough detail for a reviewer to understand the impact.
- Enter the storage condition and BUD section, including the water activity method and value when used, then state the rationale for the assigned beyond-use date.
- Complete the final review, confirm whether the preparation is released for use, and capture the reviewer signature and review date before dispensing or delivery.
Best practices
- Use structured fields for dates, times, and numeric water activity values so reviewers do not have to interpret free text.
- Record ingredient lot numbers at the time of weighing or measuring, not after the batch is finished.
- Keep the compounding steps concise but specific enough that another pharmacist could reproduce the preparation from the record.
- Use conditional logic to show water activity fields only when that measurement is part of the BUD decision.
- Document deviations immediately and state whether the batch was held, corrected, or released with justification.
- Make the final review a hard stop before release so no one signs off on an incomplete record.
- Note storage conditions in plain language, including refrigeration or room temperature, because the BUD depends on how the product is kept.
What this template typically catches
Issues teams running this template most often surface in practice:
Common use cases
Frequently asked questions
What does this template cover?
It covers a single nonsterile compounding event from the prescription or order basis through final review and release. The form captures record identification, formulation details, ingredient traceability, process checks, water activity, storage conditions, and the assigned beyond-use date. It is designed to leave a clear audit trail for how the preparation was made and why the BUD was chosen.
When should I use this record instead of a simpler log?
Use it whenever you need a formal USP 795 compounding record with traceability and documented BUD rationale. It is especially useful for compounded preparations where ingredient lots, equipment, in-process checks, or water activity affect stability. A simpler log is usually not enough when you need to show how the batch was prepared and reviewed.
Who should complete and review the form?
The preparer should complete the compounding details during or immediately after the process, and a second qualified reviewer should verify the record before release. The checker or reviewer should confirm the formulation basis, ingredient traceability, water activity entry, and final BUD assignment. This separation supports a stronger audit trail and reduces transcription errors.
How often is this template used?
It is used once per compounded preparation or batch, not as a monthly summary. Each event should have its own record number, date, time, and release decision so the documentation matches the actual preparation. If the same formula is compounded repeatedly, each run still needs a separate completed record.
What should I do if water activity is not measured?
If water activity is not measured, the form should clearly show that the BUD was based on another documented rationale allowed by your workflow and applicable policy. Do not leave the field blank without explanation, because the reviewer needs to understand how the date was assigned. If your process depends on water activity, use progressive disclosure to require the method and value when the measurement is performed.
Can this template be customized for different dosage forms?
Yes. The dosage form, compounding basis, storage condition, and in-process checks can be adapted for creams, suspensions, capsules, solutions, or other nonsterile preparations. Keep the core traceability fields intact so the record still shows what was made, from what ingredients, and under what conditions.
What are the most common mistakes when using this form?
Common mistakes include leaving the BUD rationale vague, skipping equipment notes, and entering free-text dates where a structured date field is needed. Another frequent issue is documenting the final review after release instead of before it. The form works best when required versus optional fields are clear and the reviewer signs only after all critical checks are complete.
How does this compare with ad hoc compounding notes?
Ad hoc notes are harder to audit because they often miss lot numbers, process checks, or the reason behind the assigned BUD. This template standardizes the record so the same information is captured every time, which improves consistency and reduces rework during review. It also makes it easier to train staff and spot recurring deviations.
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