What is required for a compounded product to exceed a 7-day expiration?

For a compounded product to exceed a 7-day expiration, having in-house data or literature that assures stability and sterility is crucial. This requirement ensures that the compounded preparation is safe and effective for the intended duration beyond the typical short expiration date.

In-house data may include specific studies or results collected from stability tests conducted in the pharmacy that demonstrate how long the compounded product maintains its desired attributes when stored under defined conditions. Additionally, published literature that discusses the stability of the specific components or similar formulations can also support the extension of the expiration date.

Stability and sterility are critical in compounding as they directly impact the medication's efficacy and safety. Without the necessary data to establish that a compounded product remains stable and sterile over an extended period, extending the expiration date could lead to patient harm due to degradation of the product or potential contamination.

The other options, while they may have their specific roles in pharmacy practice, do not provide the essential stability and sterility assurance required for extending the expiration date of compounded products.