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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).
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.
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.
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.
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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Category 1 CSPs are defined as \u201cCSP that is assigned a BUD of 12 hours or less at controlled room temperature or 24 hours or less refrigerated that is compounded in accordance with all applicable requirements for Category 1 CSPs in this chapter.\u201d Category 1 CSPs may be prepared in an unclassified Segregated Compounding ...
Pharmaceutical Compounding \u2013 Sterile Preparations Medications that are required to be sterile include those administered through injection, intravenous infusion (IV), intraocular (injection in the eye) or intrathecal (injection in the spine).
Examples of Sterile preparation in a sentence Sterile preparation means any dosage form devoid of viable microorganisms, including but not limited to, parenterals, injectables, ophthalmics, and aqueous inhalant solutions for respiratory treatments.
Sterile compounding are medications made in an environment free from infectious microorganisms. This method is used for drugs that are administered by injections, through an IV, or directly into the eyes.
Compounded Sterile Preparations Pharmacy ensures that sterile preparations meet the clinical needs of patients, satisfying quality, safety, and environmental control requirements in all phases of preparation, storage, transportation, and administration in compliance with established standards, regulations, and ...

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