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USP 795, 797, and 800 refer to standards that are set in place for settings and for professionals who create compounds of admixtures, reconstitutions, or dilutions for nonsterile, sterile, and hazardous drug preparation.
Examples of risk level 1 processes include transferring a sterile drug product from a vial into a commercially pro duced i.v. bag; compounding total parenteral nutrient (TPN) solutions by combining dextrose injection and amino acids injection via gravity transfer into a sterile empty container, with or without the
Combining three or more ingredients or packages, multiple additive injections, or non-sterile ingredients indicated medium to high-risk. The higher the risk level, the greater risk for contamination or lack of sterility, leading to increased risk for patient harm.
USP : Translating low, medium, and high-risk compounding into categories. USP Chapter categorizes risk levels based on the likelihood of contamination of a compounded sterile preparation (CSP).
Simplified compounded sterile preparation (CSP) microbial risk levels from three (low, medium, and high) to twoCategory 1 CSPs and Category 2 CSPs.
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Category 3 CSPs are assigned a BUD based on compounding method and the CSPs storage conditions. The microbial contamination risk levels were determined based on specific conditions listed for each risk level.
We can compound sterile ophthalmic drops, ointments, sprays, injections and pre-op solutions, including anesthetics, antibiotics, antioxidants, antivirals, cataract therapies, corticosteroids, ophthalmic decongestants, miotics, mydriatics, and lubricants.
4 risk levels. Low-risk, medium-risk, high-risk, and immediate-use. What is the term for the date after which a CSP is no longer sterile, stable, or effective and must not be used?

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