USP <795> Non-Sterile Compounding SOP Guide & Best Practices

Standard Operating Procedure: Non-Sterile Compounding

This Standard Operating Procedure (SOP) outlines the mandatory protocols for the preparation of non-sterile compounded preparations within this facility. Adherence to these guidelines is essential to ensure compliance with USP <795> standards, minimize cross-contamination, protect personnel, and guarantee the safety and efficacy of all compounded medications. All compounding personnel must review this document annually and demonstrate competency in the procedures described herein.

1. Preparation and Facility Setup

• Decontamination: Thoroughly clean and sanitize the designated compounding area (work surface, scales, and utensils) using a validated cleaning agent before beginning any activity.
• Documentation: Retrieve the Master Formulation Record (MFR) and ensure all necessary ingredients, equipment, and reference materials are present.
• Personal Protective Equipment (PPE): Don appropriate PPE, including a clean lab coat, hair net, face mask, and powder-free gloves. Change gloves immediately if they become soiled or torn.
• Calibration: Verify that the analytical balance is leveled and calibrated according to the daily calibration log.

2. Compounding Execution

• Ingredient Verification: Perform a "double-check" of all chemicals and active pharmaceutical ingredients (APIs). Verify the expiration date, lot number, and that the physical appearance matches the certificate of analysis.
• Weight/Measurement Accuracy: Measure ingredients using calibrated equipment. If compounding requires complex mixing, use geometric dilution to ensure uniform distribution of the API.
• Compounding Log: Record every step on the Compounding Record (CR) in real-time, including lot numbers, weights, and the initials of the compounder.
• Calculations: Perform all mathematical calculations independently and have them double-checked by a second qualified staff member before initiation.

3. Quality Assurance and Packaging

• Visual Inspection: Conduct a final inspection of the finished product for signs of instability, such as color change, phase separation, precipitation, or clumping.
• Packaging: Select appropriate containers that meet USP requirements for light resistance and moisture protection (e.g., amber glass or high-density polyethylene).
• Labeling: Apply a label that includes the compound name, concentration, beyond-use date (BUD), storage instructions, and necessary auxiliary labels (e.g., "Shake Well," "Keep Refrigerated").
• Final Review: The supervising pharmacist must perform a final sign-off on the CR, ensuring all weights, calculations, and labeling requirements meet the MFR specifications.

4. Sanitation and Waste Management

• Waste Disposal: Dispose of all chemical waste and contaminated materials in accordance with local environmental and hazardous waste regulations.
• Deep Clean: Conduct a terminal cleaning of the compounding station, including the removal of any residual powder or liquid residue.
• Documentation: Record the cleaning activity in the sanitation log and ensure all equipment is returned to its designated storage location.

Pro Tips & Pitfalls

• Pro Tip: Geometric Dilution is Non-Negotiable. When mixing small amounts of potent API with larger amounts of excipient, always use the geometric dilution method to prevent "hot spots" of concentrated medication.
• Pro Tip: Batch Segregation. Never work on two different compounds simultaneously at the same station. Clear the bench completely between preparations to avoid cross-contamination.
• Pitfall: Improper BUD assignment. Assigning a Beyond-Use Date (BUD) based on assumptions rather than USP <795> guidelines is a common regulatory violation. Always reference the specific stability data or conservative default BUDs provided in your SOP.
• Pitfall: Ignoring Environment. Do not overlook ambient conditions. Excess humidity or temperature in the lab can significantly degrade hygroscopic powders and shorten the shelf life of your finished product.

Template Document: USP <795> Non-Sterile Compounding SOP Guide & Best Practices

This Standard Operating Procedure establishes the mandatory requirements for non-sterile compounding activities to ensure patient safety and regulatory compliance. It is intended for use by all pharmacy personnel involved in the preparation, verification, and documentation of non-sterile compounded medications.

• Document owner: [Department Manager]
• Effective date: [Date]
• Version: [Version number]
• Applies to: [Compounding Pharmacy Staff]

Roles and responsibilities

Steps

1. Verify that the compounding area is clean and free of unrelated materials before starting the [Procedure Name].
2. Confirm that all required ingredients are present and match the [Master Formulation Record] exactly.
3. Calibrate the [Scale Name] to ensure accuracy within the [Tolerance Limit] before weighing any active pharmaceutical ingredients.
4. Don appropriate personal protective equipment, including [Type of Gloves] and [Type of Gown], to maintain product integrity.
5. Measure each ingredient precisely using the [Measurement Tool] and record the values in the compounding log.
6. Combine ingredients according to the specific mixing sequence outlined in the [Formulation Record] to ensure uniform distribution.
7. Perform a visual inspection of the final preparation to check for [Specific Characteristic] or signs of contamination.
8. Label the final container with the [Patient Name], [Beyond Use Date], and [Storage Instructions] immediately after preparation.
9. Document the final yield of the compound and compare it against the [Expected Yield Amount] to ensure accuracy.
10. Sanitize all equipment and work surfaces using [Cleaning Agent] according to the established sanitation schedule.
11. Dispose of all compounding waste, including [Waste Type], in the designated containers as per facility policy.
12. Store the finished preparation in the [Storage Location] at the required temperature of [Temperature Range].

Record of completion

• Prepared by: [Full name]
• Reviewed by: [Full name]
• Date completed: [Date]
• Signature: ______________________
• Date signed: [Date]

Frequently Asked Questions (FAQ)

Q: How often must equipment like scales be calibrated? A: Balances must be calibrated daily before use, or whenever the equipment is moved. A full performance check by a certified technician should occur annually.

Q: What should I do if I detect a discrepancy in a weight during compounding? A: Stop immediately. Notify the supervising pharmacist, document the discrepancy in the error log, discard the compromised preparation, and restart the process using fresh ingredients.

Q: Can I use tap water for compounding preparations? A: No. USP standards require the use of Purified Water (USP grade) for all non-sterile compounded preparations unless otherwise specified in the Master Formulation Record.