When are lot numbers required for documentation of the compounding of sterile products?

Lot numbers are crucial for ensuring the safety and traceability of compounded sterile products, particularly when non-sterile ingredients are involved. The requirement for lot numbers in this context serves several purposes. First, it facilitates the tracking of specific batches of ingredients used in compounding, which is essential for quality assurance and safety monitoring. By documenting the lot numbers, any potential issues related to contamination or recalls can be traced back to the specific ingredients used, allowing for swift action to safeguard patients' health.

In contrast, while compounded sterile products prepared using entirely sterile ingredients may not necessitate lot numbers, it is considered good practice to maintain thorough records for all preparations. However, in situations involving non-sterile components, the inclusion of lot numbers becomes imperative to adhere to regulatory compliance and maintain patient safety standards.

The other options do not accurately reflect the regulatory expectations surrounding lot number documentation in compounding practices. For example, while high-risk products involve stricter controls, it is the use of non-sterile ingredients that specifically triggers the necessity for recording lot numbers.