What is a requirement for labels of batch produced CSP?

Batch-produced compounded sterile preparations (CSPs) require a control or lot number on their labels to ensure traceability and identification throughout their lifecycle. This number is essential for tracking and quality control, particularly in the event of a recall or investigation into product safety and efficacy. The lot number helps to identify the specific batch of CSP produced, facilitating proper management in case of any discrepancies.

Including this information is critical in a compounding pharmacy setting to maintain compliance with regulatory standards and ensure that proper documentation and quality assurance processes are followed. It contributes to the overall safety and effectiveness of compounded medications, allowing healthcare providers to communicate specific details about each batch effectively.

While other options, such as expiration dates and storage temperatures, may also be relevant in certain contexts, the requirement for a control or lot number is a fundamental aspect of labeling batch-produced CSPs that focuses on safety, traceability, and regulatory compliance.