35 Chapter 35: Compounded Products from other Pharmacies

The practice of ordering or receiving compounded products from other pharmacies is an essential part of many pharmacy operations, particularly when a requested compounded preparation is not available in-house or requires specialized expertise. The NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations and its associated Guidance Document provide specific guidelines to ensure these transactions are performed safely, accurately, and in full compliance with regulatory standards.

1. Ensuring Compliance with Regulations

When ordering compounded products from another pharmacy, it is important to verify that the other pharmacy is licensed and operates in compliance with the relevant pharmacy regulatory authorities (provincial or territorial). The pharmacy must ensure that the compounded products meet the required standards, and that the compounding pharmacy follows appropriate policies and procedures for non-sterile compounding.

2. Communication Between Pharmacies

Clear and effective communication is key when ordering compounded products from another pharmacy. Below are the primary points of communication:

• Initial Request: The pharmacy placing the order must provide a clear and detailed request to the compounding pharmacy. This includes the type of product, dosage form, strength, quantity, and any special requirements (e.g., specific excipients or allergens). This communication should also address the expected beyond-use date (BUD), packaging requirements, and any handling or storage conditions.
• Documentation of the Request: The pharmacy placing the order should document the request in writing, either through a formal order or prescription, and ensure the order is tracked. This documentation serves as a record of the transaction for future reference and regulatory compliance.
• Confirmation and Verification: Once the compounding pharmacy confirms the order, they should verify the details with the requesting pharmacy, ensuring that both parties agree on the specifications of the compounded preparation. This includes confirming the ingredients, method of compounding, and quality control procedures.
• Notification of Receipt: Upon receiving the compounded product, the receiving pharmacy must ensure that the product is accompanied by all required documentation, including certificates of analysis, lot numbers, and the product’s BUD. Any discrepancies or damages should be reported immediately to the compounding pharmacy.

3. Recordkeeping and Documentation

Both the ordering and receiving pharmacies must maintain accurate records of all compounded product transactions, in compliance with provincial/territorial pharmacy regulations. This includes:

• Master Formulation Record (MFR): The receiving pharmacy should have access to the Master Formulation Record (MFR) from the compounding pharmacy to ensure the product is compounded as per the agreed-upon standards.
• Compounding Record: The receiving pharmacy should maintain a compounding record for each batch or individual compounded product received. This should include details of the ordering pharmacy, product specifications, quantities, lot numbers, BUD, and any quality control measures undertaken by the compounding pharmacy.
• Audit Trail: An audit trail should be maintained to trace the source and quality of compounded preparations. This documentation can be used to identify any quality issues or non-compliance with standards.

4. Ensuring the Product’s Safety and Quality

Before dispensing any compounded product received from another pharmacy, the receiving pharmacy must assess the product’s safety and quality. This involves:

• Verification of Labeling: The product must be properly labeled with the required information, including the BUD, the active ingredients, the strength, and the dosage form. Any specific storage or handling instructions must also be clearly indicated.
• Physical Inspection: The compounded product should be visually inspected to ensure it is free from contamination, damage, or degradation. The packaging should be intact, and the product should appear as expected based on the specifications provided by the compounding pharmacy.

Stability and Storage: The receiving pharmacy must confirm that the compounded product is stored under the conditions specified by the compounding pharmacy to maintain its stability and effectiveness. If the product requires refrigeration, protection from light, or specific temperature controls, these conditions should be strictly adhered to.

5. Communication of Adverse Reactions or Issues

If any issues arise after the compounded product is dispensed (e.g., patient complaints, adverse reactions, or quality issues), it is critical that the receiving pharmacy communicate these findings back to the compounding pharmacy. This communication should include:

• Detailed Description of the Issue: Provide a clear description of the problem or adverse reaction, including the lot number, patient information, and any other relevant details.
• Follow-up Actions: The receiving pharmacy should work with the compounding pharmacy to investigate the issue, implement corrective actions, and prevent future occurrences. This could involve recalling the product, adjusting procedures, or reviewing the quality assurance processes.

6. Regulatory Compliance

Both pharmacies must ensure they comply with the relevant provincial/territorial pharmacy regulations regarding the ordering, receiving, and dispensing of compounded products. This includes maintaining records, meeting labeling and storage requirements, and ensuring that the compounded preparations are made following appropriate safety and quality standards.

In summary, the procedures for ordering and receiving compounded products from other pharmacies require clear communication, rigorous documentation, and adherence to both NAPRA standards and provincial/territorial regulations. Pharmacies must ensure that they are sourcing products from licensed compounding pharmacies that follow high-quality standards, and they must maintain records of the transaction for future accountability. By following these procedures, pharmacies can safeguard the integrity of compounded products and ensure the safety and wellbeing of their patients.