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Run: 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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Record Identification

Record Number

System-generated unique identifier for this compounding record.

Compounding Date (required)

Date the nonsterile compounding event was performed.

Compounding Time (required)

Time the compounding event was started or completed, as used by your facility's recordkeeping process.

Pharmacy or Facility Name (required)

Preparer Name (required)

Name or identifier of the individual who prepared the compound. Collect only what is needed for the audit trail.

Independent Checker / Reviewer

Name or identifier of the person who performed the independent review, if applicable.

Formulation and Prescription Basis

Prescription or Order Reference (required)

Reference number or internal order identifier used to link this record to the source order.

Dosage Form (required)

Compounding Basis (required)

Master Formulation Record Reference

Reference ID for the master formulation record, if used.

Formulation Name (required)

Intended Use / Route

Optional route or intended use if needed for internal documentation.

Ingredients and Lot Traceability

Ingredients (required)

List each ingredient used in the compound, including lot-level traceability and quantity used.

Equipment Used (required)

Equipment Notes

Describe any additional equipment used that is not listed above.

Compounding Process and Quality Checks

Compounding Procedure Summary (required)

Brief summary of the actual compounding steps performed. Include only the information needed for reproducibility and review.

In-Process Checks Performed (required)

Check Notes

Record results of in-process checks, including any out-of-trend observations.

Did any deviation occur? (required)

Deviation Description

Describe the deviation and any immediate containment or corrective action taken.

Water Activity and Beyond-Use Dating

Was Water Activity Measured? (required)

Water Activity Value (aw)

Enter the measured water activity value, if available.

Water Activity Test Method

Identify the method or instrument used for water activity determination.

Storage Condition (required)

Storage Notes

Describe any special storage requirements or exceptions.

Assigned Beyond-Use Date (required)

The final beyond-use date assigned according to the applicable USP 795 framework and internal policy.

BUD Basis (required)

BUD Rationale (required)

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

Final Review Completed (required)

Confirm that the record was reviewed for completeness and accuracy.

Yes No N/A

Released for Use (required)

Release Notes

Explain why the compound was not released, if applicable.

Reviewer Signature (required)

Signature of the person performing final review or approval.

Review Date (required)

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