What is the maximum number of sterile products that can be pooled together for medium risk CSPs?

In the context of compounding sterile preparations, particularly medium-risk compounding, it's essential to understand the guidelines provided by the United States Pharmacopeia (USP), specifically USP <797>. Medium-risk compounding typically involves the preparation of multiple individual sterile products that are combined to create a final sterile preparation.

When pooling sterile products for medium-risk compounded sterile preparations (CSPs), there is no strict upper limit imposed on the number of products that can be pooled together, as long as the final preparation meets the necessary sterility and safety standards. By allowing for more than three products to be pooled, it reflects the practical approaches often employed in hospital settings where multiple vials or containers may be needed to achieve the desired therapeutic outcome.

However, it’s critical to ensure that the compounding process adheres to all aseptic techniques, with careful consideration of stability, compatibility, and sterility of the pooled components. This flexibility in pooling is essential for creating complex parenteral therapies while maintaining patient safety.

Thus, stating that the maximum number of sterile products that can be pooled together for medium-risk CSPs is more than three aligns with established practice standards and the nature of medium-risk compounding.