What must be included on the label of compounded prescriptions?

The inclusion of a Beyond Use Date (BUD) on the label of compounded prescriptions is critical for ensuring patient safety and product efficacy. The BUD indicates the date after which the compounded preparation should not be used, as its stability and potency cannot be guaranteed beyond that time. This is particularly important for compounded medications, which may not have the same shelf-life as commercially available products due to their custom formulations and the absence of preservatives.

Regulatory guidelines, such as those from the United States Pharmacopeia (USP), specify that the BUD must be determined based on the preparation methods and ingredients in the compound. By providing a BUD on the label, pharmacists help to ensure that patients are using medications that are safe and effective, while also adhering to best practices in compounding pharmacy.

Including information like directions for use or expiration dates may be helpful, but they do not carry the same regulatory significance as the BUD in the context of compounded prescriptions. Additionally, while manufacturer information is relevant for commercially available products, it is not typically applicable to compounded medications, which are specifically tailored for individual patients and may not come from a manufacturer. Thus, marking the BUD is a vital component of labeling for safety and compliance in the realm of compounded prescriptions.