22 Chapter 22: Maintaining Quality and Safety of the Compounded Preparation

Maintaining the quality and safety of compounded preparations is essential from the point of preparation until the final product is dispensed or delivered. The following elements must be addressed to ensure the integrity, efficacy, and safety of compounded non-sterile and sterile products prior to patient use.

Final Product Verification

Each compounded preparation must undergo a final check before release.

Verification includes confirming:

• Correct formulation and ingredients
• Accurate calculations and measurements
• Proper labeling and auxiliary instructions
• Absence of visible contaminants or physical defects

Only qualified personnel should perform this final verification, and it must be documented.

Packaging Requirements

Use packaging materials that are:

• Compatible with the preparation
• Protect the product from contamination, light, moisture, and degradation
• Appropriate for the dosage form (e.g., amber bottles for light-sensitive products, child-resistant containers)
• Packaging must be tamper-evident when appropriate.

Storage Conditions

• Store compounded products under conditions specified in the formulation record or product monograph (e.g., room temperature, refrigerated).
• Use clearly labeled storage areas that prevent cross-contamination or product mix-ups.
• Environmental conditions such as temperature and humidity must be monitored and documented.

Beyond-Use Dating (BUD)

Assign and label appropriate BUDs based on:

• Stability data
• Type of preparation (aqueous, non-aqueous, etc.)
• Storage conditions
• NAPRA standards
• Ensure that the product is dispensed or transported within the valid BUD timeframe.

Quarantine and Release Protocols

• Products must be quarantined until all quality checks are completed.
• No product should be dispensed or transported without documented release authorization.
• Any preparation failing quality checks must be discarded according to hazardous or non-hazardous waste protocols.

Documentation

Maintain records of:

• Compounding logs and batch records
• Verification and release checks
• Environmental and equipment monitoring
• Corrective actions taken for deviations or quality issues

Transportation Considerations

If a compounded preparation is to be delivered or transported:

• Package securely to prevent leakage, breakage, or exposure to adverse conditions
• Use temperature-control measures when necessary (e.g., cold packs, insulated containers)
• Label outer packaging clearly with any necessary handling or storage instructions
• A tracking system should be in place to monitor delivery timelines and ensure timely receipt by the patient or caregiver.

Incident and Recall Procedures

• Establish procedures for handling product complaints, suspected contamination, or quality issues post-release.
• Implement a recall process that allows rapid identification and retrieval of affected batches, if needed.