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Beyond use dating applies the same expiration dating principles, but adds the consideration of sterility. USP > presents maximum BUDs for 3 contamination categories (low, medium, and high) for compounded sterile preparations.



Beyond Use Date (BUD)

Usp 797 sterility dating

Usp 797 sterility dating


Often these guidelines are established and maintained at individual practicing locations with varying levels of detail and accuracy. The chemical stability must also be cross-referenced with current US Pharmacopeial Convention standards to ensure that sterility is maintained throughout the storage period. We developed several assumptions before researching the available literature on chemical stability. These guidelines were not intended for proprietary bag systems, as manufacturer-specific guidance would be sought for those systems. This assumption applied to the reconstituted vial and the compounding of the admixture. After the guideline was developed, it was reviewed for accuracy by the second author N.

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Usp 797 sterility dating

Usp 797 sterility dating


Often these guidelines are established and maintained at individual practicing locations with varying levels of detail and accuracy. The chemical stability must also be cross-referenced with current US Pharmacopeial Convention standards to ensure that sterility is maintained throughout the storage period. We developed several assumptions before researching the available literature on chemical stability. These guidelines were not intended for proprietary bag systems, as manufacturer-specific guidance would be sought for those systems. This assumption applied to the reconstituted vial and the compounding of the admixture. After the guideline was developed, it was reviewed for accuracy by the second author N. Usp 797 sterility dating

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Sterile Compounding of a Gentamicin Bag

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