Must a CSP label always include an auxiliary label?

In sterile compounding practice, while auxiliary labels can provide important supplementary information about a compounded sterile preparation (CSP), their inclusion is not a strict requirement for the label of every CSP. Auxiliary labels are often used to convey special handling precautions, storage conditions, or administration instructions that can enhance the safety and efficacy of the preparation. However, the core requirement is that a CSP label must include essential information such as the drug name, strength, quantity, beyond-use date, and any necessary storage instructions.

The flexibility in the use of auxiliary labels means that not every compounded sterile product will necessarily require them. For instance, specific circumstances may warrant additional labeling for clarity or safety, but there is no blanket mandate for their inclusion on all CSP labels. This allows for a tailored approach based on the type of preparation, the patient, or other relevant factors, which ensures adherence to USP 797 guidelines while maintaining efficiency in compounding practice.