797 guidelines beyond use dating

797 guidelines beyond use dating

Is beyond use dating applicable for batch compounding?

The beyond use dating would only be applicable under the assumption that the admixture was compounded for a single patient and not for anticipated batch compounding. The associated beyond use dating for batch compounding would be adjusted for compounding risk level and assigned through an automated system for capturing batch-specific information.

What is the purpose of the beyond use dating guideline?

The primary goal of the beyond use dating guideline was to provide a comprehensive information source for safe and consistent admixing. Published references were used to find extended chemical stability at reference ranges, which were indicated within the chart.

What is the beyond use dating guideline for sterile products?

The beyond use dating guideline is to serve as a guide, not a pdf, for appropriate use of beyond use dating of sterile products. Some of information is specific to operations at specific facilities and therefore must not be used without a thorough pdf of its appropriateness at other facilities.

What are the USP compounding standards and beyond-use dates?

USP Compounding Standards and Beyond-Use Dates (BUDs) On June 1, 2019, USP published updates to the USP General Chapters on compounding nonsterile and sterile preparations alongside new standards for compounding radiopharmaceutical drugs.

What does beyond use date mean for sterile compounding?

BEYOND USE DATING FOR STERILE COMPOUNDING. 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.

What are the USP compounding standards and beyond-use dates?

USP Compounding Standards and Beyond-Use Dates (BUDs) On June 1, 2019, USP published updates to the USP General Chapters on compounding nonsterile and sterile preparations alongside new standards for compounding radiopharmaceutical drugs.

What are beyond-use dates (buds)?

Beyond-use dates (BUDs) are the date or time after which a compounded sterile preparation (CSP) or compounded nonsterile preparation (CNSP) may not be stored or transported and are calculated from the date or time of compounding. Why are Beyond-Use Dates Necessary?

What is the purpose of the beyond use dating guideline?

The beyond use dating guideline is to serve as a guide, not a resource, for appropriate use of beyond use dating of sterile products. 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.

Whats new with USPs compounding standards?

On June 1, 2019, USP published revisions to General Chapter <795> for nonsterile compounding and General Chapter <797> for sterile compounding, as well as a new General Chapter <825> for radiopharmaceuticals. After publication of the revised and new compounding standards, USP received appeals on certain provisions in <795>, <797>, and <825>.

What are USP general chapters for compounding?

USP General Chapters for compounding establish procedures, methods and practices that are utilized by practitioners to help ensure the quality of compounded preparations. There are several essential compounding General Chapters:

Do compounded preparations meet USP standards for buds?

Some compounded preparations—such as those in USP compounding monographs or in peer-reviewed literature—have undergone testing according to USP standards to support a specific BUD. However, most compounds have not undergone such studies, so depend on the default BUDs established in <795>. (See Table 3 .)

What are the standards of care for nonsterile compounding?

General Chapter USP <795> presents the standards of care required when nonsterile preparations are compounded. Major elements include USP <795> defines three categories of nonsterile compounding: simple, moderate, and complex.

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