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Run: USP 795 Compounding Record and Beyond-Use Dating

A USP 795 Compounding Record and Beyond-Use Dating template for documenting nonsterile compounding, ingredient traceability, water activity, and the assigned...

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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 started or was completed.

Compounding Type (required)

Select the dosage form being prepared.

Prescription or Order Reference (required)

Internal prescription, order, or batch reference used for traceability.

Patient Identifier

Use the minimum necessary patient identifier required by your workflow. Avoid collecting full PII unless needed.

Formulation and Basis

Formulation Name (required)

Name of the compounded preparation.

Basis for Compounding (required)

Select the basis used to prepare the compound.

Reference Sources

List any references consulted during compounding.

Intended Route of Administration (required)

Select the intended route for the nonsterile preparation.

Special Handling Notes

Document any handling precautions, storage constraints, or formulation-specific considerations.

Ingredients and Traceability

Ingredients (required)

Enter each ingredient used in the compound, including lot traceability and quantity.

Ingredient Notes

Document substitutions, reconstitution details, or any ingredient-specific observations.

Compounding Procedure

Equipment Used (required)

Select the equipment used during compounding.

Compounding Steps (required)

Describe the compounding steps performed in sequence, including any critical manipulations.

Deviations or Variances

Document any deviations from the master formulation record, procedure, or expected process.

In-Process Checks

Select any in-process quality checks performed.

Water Activity and Beyond-Use Dating

Was Water Activity Measured? (required)

Indicate whether a water activity measurement was performed for this preparation.

Water Activity Value

Enter the measured water activity value if available.

Water Activity Method

Document the instrument or method used to determine water activity.

Beyond-Use Date Basis (required)

Select the rule used to assign the beyond-use date.

Assigned Beyond-Use Date (required)

Date after which the compounded preparation should not be used.

BUD Rationale (required)

Explain how the beyond-use date was determined, including any water activity threshold or policy basis used.

Review, Release, and Certification

Final Quality Review Completed (required)

Confirm that the final preparation was reviewed before release.

Release Status (required)

Select the disposition of the compounded preparation.

Reviewer Name (required)

Name of the person performing the final review.

Reviewer Signature (required)

Electronic signature of the responsible reviewer.

Review Date (required)

Date the record was reviewed and approved.

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