What is the Beyond Use Dating in the freezer for both High Risk and Medium Risk preparations?

Beyond Use Dating (BUD) is a critical concept in sterile compounding which refers to the date after which a compounded preparation should not be used. For High Risk and Medium Risk preparations stored in a freezer, the guidelines specify a particular BUD to ensure the safety and efficacy of the preparation.

For both High Risk and Medium Risk compounded sterile preparations, the BUD in the freezer is set at 45 days. This timeline is based on stability studies and regulations that ensure compounded medications maintain their integrity and potency throughout their suggested usage period. The 45-day BUD helps mitigate risks associated with the potential growth of microorganisms and degradation of the active ingredients, which can occur over time even in frozen conditions.

Understanding BUD is essential for maintaining compliance with pharmacy standards and for ensuring patient safety. Proper adherence to these guidelines reflects on the quality control measures in place for compounded sterile preparations. Missing the parameters set for BUD could compromise patient care and outcomes, as the preparations may become unsafe or ineffective beyond the indicated timeframe.