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USP 797 (Created with 2019 update) Flashcards | Quizlet
The storage time of a CSP must not exceed the original BUD placed on the CSP for its labeled storage condition. For example, a CSP that is assigned a BUD based
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General Chapters: <797> PHARMACEUTICAL COMPOUNDING
Personnel who prepare, dispense, and administer CSPs must store them strictly in accordance with the conditions stated on the label of ingredient products and finished CSPs.
Establishing Beyond Use Dates for Category 1 and 2
Verify manufacturer information on stability and expiration. Assign the shorter time based on the stability data, the expiration data, and the BUDs listed in Table 1. *Only Category 2 CSPs prepared from
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USP Compounding Standards and Beyond-Use Dates (BUDs)
A CSP''s or CNSP''s BUD identifies the time by which the preparation – once mixed – must be used before it is at risk for physical or chemical degradation, microbial contamination and proliferation, and
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USP Chapter 797 regulations (Compounded Sterile
Section 503A of the FD&C Act: allows pharmacist or licensed physician to be exempt from commercial manufacturing regulations (cGMP) when: -CSPs are
Applying Stability Data in Sterile Compounding
The USP recognizes the risks of microbial contamination as a contributor to patient safety and sets limits on the length of time a compounded sterile preparation
DRAFT ASHP Guidelines on Compounding Sterile Preparations
A CSP''s stability—and clinical effect—can be impacted by negligible changes to 312 manufactured dosage forms, which requires pharmacists to evaluate various preparation-313 specific conditions
Defining Storage and Administration Terms for CSPs
Think of the BUD as a storage time: from the point the CSP mixing begins until the point when administration to the patient begins. With the onset of administration, the BUD no longer
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USP <797> Cold Storage Requirements: What
The temperature at which you store a CSP directly affects its beyond-use date (BUD) and microbial safety. Storage in a refrigerator or freezer