Compounded sterile preparations definition

Compounded sterile preparations or “CSPs” means a sterile drug or nutrient compounded in a licensed pharmacy or other healthcare-related facility pursuant to the order of a licensed prescriber; the article may or may not contain sterile products.
Compounded sterile preparations means biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that, under USP 797, must be compounded using aseptic techniques.

Examples of Compounded sterile preparations in a sentence

  • The sterilization cycle shall be designed to achieve a sterility assurance level of 10-6.3. Compounded sterile preparations shall be placed in trays which allow steam to reach the compounded sterile preparations without entrapment of air.

  • Compounded sterile preparations, including hazardous drugs and radiopharmaceuticals, shall be prepared only under conditions that protect the pharmacy personnel in the preparation and storage areas.

  • Compounded sterile preparations containing a preservative added by the compounder shall pass an antimicrobial effectiveness testing with the results obtained on the specific formulation before any of the compounded sterile preparation is dispensed.

  • Compounded sterile preparations are exempted from the requirements described in this paragraph for low-risk level compounded sterile preparations when all of the following criteria are met.

  • The sterilization cycle shall be designed to achieve a sterility assurance level of 10−6.3. Compounded sterile preparations shall be placed in trays which allow steam to reach the compounded sterile preparations without entrapment of air.

  • Vocational-technical courses, except those included in articulation agreements for the specific major or college/school.

  • Compounded sterile preparations are exempted from the 666 requirements described in this paragraph for low-risk level compounded sterile preparations 667 when all of the following criteria are met.

  • Compounded sterile preparations, including haz- ardous drugs and radiopharmaceuticals, shall be prepared only under conditions that protect the pharmacy personnel in the preparation and storage areas.

  • Compounded sterile preparations containing more than three commercial sterile drug products and those requiring complex manipulations and/or preparation methods must comply with the medium-risk level standards described in paragraph (2)(B) of this subsection.

  • Compounded sterile preparations prepared from nonsterile ingredients or components must comply with the high-risk level standards described in paragraph (2)(C) of this subsection.

Related to Compounded sterile preparations

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