Usp 797 bud dating

For each medication listed, information was provided that was vital to safe, accurate, and consistent compounding throughout the organization. These guidelines were not intended for proprietary bag systems, as manufacturer-specific guidance would be sought for those systems. In addition, nonreferenced manufacturer medication information may differ in stability data. We developed several assumptions before researching the available literature on chemical stability. Published references were used to find extended chemical stability at reference ranges, which were indicated within the chart. Supplementary Material Click here for additional data file. These guidelines may serve as an operational reference for compounding personnel to guide the application of appropriate beyond use dating in compounding single patient preparations.

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Some of information is specific to operations at specific facilities and therefore must not be used without a thorough confirmation of its appropriateness at other facilities.

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Guidelines for the Establishment of Appropriate Beyond Use Dating of Sterile Compounded Admixtures

Beyond use dating applies the same expiration dating principles, but adds the consideration of sterility. Published reference standards were consulted for information that was not found within the package insert. We developed several assumptions before researching the available literature on chemical stability. In most instances, resources provide documentation of a specific compounded admixture, at a specific concentration and storage parameters, that does not coincide with current operations or patient-specific requirements. The guideline also serves as quick reference of stability information for appropriate assignment of beyond use dating. The beyond use dating guideline is to serve as a guide, not a resource, for appropriate use of beyond use dating of sterile products. If limited chemical stability was a factor, this was indicated for applicable admixtures within the guideline by an associated expiration date.

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