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What is CSP risk level?

The appropriate risk level\u2014low, medium, or high\u2014is assigned according to the corresponding probability of contaminating a CSP with (1) microbial contamination (microbial organisms, spores, and endotoxins) and (2) chemical and physical contamination (foreign chemicals and physical matter).

What is the difference between 797 795 and 800 guidelines of USP?

USP 797 provides standards for compounding of sterile preparations while USP 800 provides standards for the safe handling of HDs to minimize exposure risks. USP 797 promotes the protection of the sterility of the drug, while USP 800 is focused on the safety of personnel who come in contact with the HDs.

What is a Category 3 CSP?

Category 3 CSPs are those that may be assigned longer BUDs than the limits for Category 1 or Category 2 CSPs, up to 180 days, if additional requirements are met. Added a maximum batch size of 250 final yield units for all CSPs requiring sterility testing.

How are compounded sterile preparations risk levels determined?

The risk level depends on the CSPs compounding environment; its potential for microbial, chemical, and physical contamination; the nature of production of the CSP. It is the responsibility of personnel to determine the correct level.

What is the difference between sterile and non sterile compounding?

Sterile compounded medications are intended to be used as injections, infusions, or application to the eye. Non-sterile medications include the production of solutions, suspensions, ointments, creams, powders, suppositories, capsules, and tablets.

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