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Run: USP 795 Nonsterile Compounding Master Formulation Record

A USP 795 Nonsterile Compounding Master Formulation Record template for documenting the formula, calculations, equipment, process, checks, labeling, storage,...

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Record Identification

Formulation Name (required)

Enter the official name of the compounded preparation.

Dosage Form (required)

Strength or Concentration (required)

Enter the intended strength, concentration, or ratio for the final preparation.

Record Version (required)

Effective Date (required)

Next Review Date (required)

Compounding Basis and References

Formula Source (required)

Identify the source used to develop this formulation record.

Reference Materials

Select any references used to support the formulation.

Therapeutic Intent

Briefly describe the intended use of the compounded preparation. Do not include unnecessary patient-specific PII.

Compounding Classification (required)

Ingredients and Calculations

Ingredient List (required)

Calculation Basis (required)

Describe the calculation method, batch size basis, and any conversion factors used.

Calculated Batch Size

Equipment and Supplies

Equipment Required (required)

Special Supplies or Packaging

List any special supplies, containers, closures, or packaging needed.

Equipment Cleaning / Preparation Notes

Document any cleaning, calibration, or setup requirements before compounding begins.

Compounding Procedure

Procedure Summary (required)

Write the step-by-step compounding procedure in clear, sequential language.

In-Process Checks (required)

Special Handling Required? (required)

Special Handling Details (required)

Describe any special handling, environmental controls, or precautions needed.

Final Product Specifications

Appearance Specification (required)

Describe the expected color, consistency, clarity, or other observable characteristics.

Packaging Requirements (required)

Specify the container, closure, and any light-resistant or child-resistant requirements.

Storage Conditions (required)

Document storage temperature, light protection, humidity, and other conditions.

Beyond-Use Date (required)

Labeling Requirements (required)

List the label statements required for safe use and storage.

Review, Approval, and Release

Prepared By (required)

Enter the name or role of the person preparing this record.

Reviewed By (required)

Enter the name or role of the reviewer.

Approved for Use (required)

Confirm that the record has been reviewed and approved before use.

Yes No N/A

Approval Notes

Add any comments, restrictions, or required revisions before release.

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