What is the expiration date requirement for compounded prescriptions?

Compounded prescriptions are unique products created to meet specific patient needs, and their stability can vary significantly based on the components used in the formulation and the storage conditions. Because of these factors, compounded medications require appropriate labeling that includes both expiration and beyond-use dates.

The expiration date is important for commercially manufactured products and indicates the date until which the product is guaranteed to remain stable and effective. However, compounded prescriptions do not have an expiration date in the same manner. Instead, they are assigned a beyond-use date, which is the date after which the compounded product should not be used. This beyond-use date is determined based on several factors, including the nature of the ingredients used, the preparation method, and the storage conditions.

Therefore, when labeling compounded prescriptions, both dates must be provided. The beyond-use date gives clear guidance on the period during which the compounded medication can be safely used while ensuring patient safety and efficacy of the medication. This dual requirement helps mitigate risks associated with using compromised medication and safeguards patient health.