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Understanding USP 71 Sterility Tests and Extended BUD

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One of the most frequently asked questions recently asks how to extend the Beyond-Use Date (BUD) of compounded sterile preparations (CSPs). Eric S. Kastango, RPh, MBA, FASHP, reviewed the requirements of USP Chapter 797 necessary to complete in order to extend BUD. The use and limitation of sterility tests according to USP 71 was reviewed, along with process verification.

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