What is the maximum beyond-use date (BUD) for compounding when a written justification is not available?

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The maximum beyond-use date (BUD) for compounded sterile preparations when a written justification is not available is commonly established as 24 hours. This aligns with guidelines for sterility and ensuring patient safety, as preparations that are compounded without a specific justification or risk assessment must adhere to conservative time limits for their use. This is particularly important in minimizing the risk of contamination or degradation of the compounded product, ensuring that patients receive safe and effective medications.

Other time frames like 12, 48, and 72 hours could apply under specific circumstances or justifications, but when no written justification is present, 24 hours is the standard limit set forth in guidelines to maintain safety and efficacy in compounded medications.

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