BUDs for Sterile Preparations and Stability in Compounding Pharmacies

Introductory Paragraph: Beyond Use Date (BUD) is very different from expiration date. USP Chapter 797 defines BUD as the date or time after which a compounded sterile preparation (CSP) may not be stored or transported and is calculated from the date or time of compounding. Expiration date is a manufacturer defined term based on very specific testing used for commercially available products. A CSP cannot be labeled with the term “expiration date” or any variance thereof. It must be labeled with a different phrase such as, “do not use after” or “use before” etc.

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