36 Chapter 36: Recalled, Returned and Expired Ingredients and Compounds

Effective management of recalled, returned, and expired components and compounded preparations is critical for maintaining patient safety, adhering to regulatory requirements, and ensuring compliance with the NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations and the associated Guidance Document. This process ensures that potentially unsafe materials or products are properly identified, segregated, and handled appropriately to minimize risks. Below are the key steps involved in managing recalled, returned, and expired components and compounded preparations:

1. Managing Recalled Components and Preparations

Recalls refer to the removal of products from circulation due to safety concerns or quality issues that may affect patient health. The management of recalled products involves:

• Receiving Recall Notifications: Regularly monitor recall notifications issued by regulatory authorities, such as Health Canada or the FDA, and from suppliers or manufacturers. This can be done through automated recall alerts or by subscribing to recall notification services.
• Segregating Recalled Items: Once a recall is identified, immediately segregate the affected products or components from active inventory. Recalled components or preparations should be clearly marked and stored separately in a designated quarantine area to prevent accidental use.
• Record Keeping: Keep detailed records of all recalled items, including the lot number, batch number, reason for recall, and action taken (e.g., return to the supplier, disposal, etc.). This helps ensure traceability and accountability.
• Notify Affected Parties: Inform all relevant parties about the recall, including patients, healthcare providers, and the compounding team. If a recalled compounded preparation has already been dispensed to a patient, provide instructions on how to safely dispose of the product or replace it with an alternative.
• Return to Supplier: In some cases, recalled components should be returned to the supplier for replacement or credit. Follow the supplier’s instructions for returning the recalled items.
• Disposal: If a component cannot be returned, ensure its safe disposal in compliance with environmental and health regulations. Hazardous materials, for instance, may require special disposal procedures.

2. Managing Returned Components and Compounded Preparations

Returns refer to products or components that are sent back to the pharmacy, either by the patient or another pharmacy. The process for managing returns includes:

• Assess the Return: When a compounded product or component is returned, assess its condition and the reason for return. If a compounded preparation is returned, it should generally not be reused or dispensed again, as it may have been altered or compromised after being in the patient’s possession.
• Segregate and Quarantine: Just like with recalled items, returned products should be immediately segregated and quarantined in a designated area away from active inventory to avoid accidental use.
• Documentation: Record the details of the return, including the product’s name, the reason for the return, the date of return, and the condition of the product. The returned product should also be logged in the pharmacy’s inventory records.
• Dispose of or Destroy: Compounded products that are returned (e.g., due to patient dissatisfaction, incorrect dispensing, or damage) should be disposed of or destroyed following proper protocols. Returned components (e.g., raw ingredients) that are unopened or unaltered may sometimes be returned to stock, provided they meet the original quality and safety criteria.
• Communicate with Patients: If the returned compounded product was dispensed to a patient, communicate with them about why the product is being returned and, if necessary, offer a replacement or alternative. Record the patient’s feedback for future reference.

3. Managing Expired Components and Compounded Preparations

Expired components and compounded preparations must be handled carefully to prevent their use and to maintain the quality and safety of all compounded products. The procedures for managing expired items include:

• Monitor Expiration Dates: Keep track of the expiration dates for all components, active ingredients, and compounded preparations. Use an inventory management system that provides alerts for items approaching their expiration date to avoid using expired materials in compounded preparations.
• Segregate Expired Items: Once the expiration date of a component or compounded preparation is reached, immediately remove it from active inventory. These items should be segregated and clearly labeled as expired to avoid accidental use.
• Dispose of Expired Items: Compounded preparations that have expired should not be used for any new patients or dispensed. These preparations should be disposed of in accordance with applicable regulations, such as pharmaceutical waste disposal guidelines. If the item is hazardous, it must be disposed of according to the appropriate hazardous waste management protocols.
• Documentation: Keep accurate records of all expired items, including their lot number, expiration date, and the disposal method. This documentation ensures traceability and helps identify any trends related to the expiration of materials, which may prompt changes in inventory or ordering practices.
• Regular Inspections: Conduct routine inventory audits to identify expired items before they are used. This proactive approach helps maintain high standards of safety and product integrity.
• Return or Exchange of Expired Components: If expired components were received from a supplier and the expiration was not properly tracked or identified, contact the supplier for a return or exchange. This is particularly important for raw materials that may affect product quality if expired.

4. Documentation and Reporting

Documentation is a key element in managing recalled, returned, and expired components and compounded preparations. The following documentation practices should be adhered to:

• Inventory Records: Maintain detailed inventory records that include the date of receipt, lot number, expiration date, and the condition of components. Use these records to track the lifespan of materials and to ensure compliance with regulatory standards.
• Quality Assurance Logs: Record all actions taken in response to recalls, returns, or expired items in the pharmacy’s quality assurance logs. These logs should include the nature of the problem, the response, and any follow-up actions that were taken.
• Reports to Regulatory Authorities: If necessary, report recalled, returned, or expired items to the appropriate regulatory authorities, especially if they pose a public health risk or affect patient safety.
• Patient Records: Document any actions taken related to recalled or returned products in the patient’s medical record, including the specific product involved, the reason for the recall or return, and any replacement product or actions taken.

Managing recalled, returned, and expired components and compounded preparations is a crucial component of the quality assurance process in non-sterile compounding. By following the required procedures, pharmacies can ensure that unsafe or compromised materials are effectively segregated, disposed of, or returned to suppliers, and that patients continue to receive safe and effective compounded products. Proper documentation, effective communication, and adherence to regulatory standards are essential for maintaining patient safety and the integrity of the compounding process.