USP 795 interpretation

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Wed, 10/07/2020 - 16:27
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Karen Thompson
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USP 795 interpretation

I'm pretty sure I am not interpretting USP 795 correctly, and wanted to get others' input... It appears that if you are compounding a non-sterile liquid, and you do not have any stability information, it is OK to give it a BUD of up to 14 days in the fridge. (The table in the USP chapter is titled "Maximum BUD by Type of Preparation in the Absence of a USP-NF Compounded Preparation Monograph or CNSP-Specific Stability Information"). Fourteen days seems awfully generous. Historically, we have only given a 1 hour BUD to items that we have no stability reference for (e.g., finasteride tablet added to an oral syringe with water to make a liquid). If we can assign a 14 day BUD, that would be fantastic, but I'm afraid my interpretation is wrong. Thoughts??

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