What is the Origin of Beyond-Use Dates?

The concept of establishing a specific "beyond-use date" originates from pharmaceutical compounding regulations, notably those established by the United States Pharmacopeia (USP) in chapters dedicated to compounding practices. This regulatory framework arose to address the inherent variability and lack of manufacturer-supplied stability data for custom-made drug preparations. Unlike commercially manufactured drugs which have expiration dates, compounded medications require this unique, clinically determined stability limit.

What is the Mechanism of Beyond-Use Dates?

The determination of a Beyond-Use Date functions as a protective measure against chemical degradation and microbial proliferation within the compounded formulation. The pharmacist evaluates factors such as the chemical stability of the active hormonal ingredient, like testosterone or estradiol, the water content of the vehicle, and the storage conditions, applying conservative guidelines from USP standards. Once the BUD is reached, the potential for drug degradation into inactive or toxic byproducts increases, or the risk of bacterial contamination surpasses acceptable limits, thereby compromising the therapeutic efficacy and patient safety.

Beyond-Use Dates ∞ Area

Beyond-Use Dates

Meaning

Beyond-Use Dates (BUDs) represent the time and date after which a compounded sterile or non-sterile preparation should not be used, essentially marking the maximum duration a compounded medication retains its potency and purity. This date is assigned by the compounding pharmacist, not the manufacturer, and is determined based on the stability data of the ingredients, the specific formulation, and the container-closure system. Adherence to these dates is a critical component of patient safety and regulatory compliance in the delivery of personalized hormonal therapies.