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What are the two purposes of the General Chapter 797?
- 1) To assure quality and accuracy in compounded sterile preparations (CSPs).
- 2) To prevent harm to patients treated with CSPs.
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The General Chapter 797 pertains to ________, ________ and ________, but not ________.
- The chapter pertains to:
- 1) Preparation
- 2) Storage
- 3) Transportation
However, the chapter does not pertain to the clinical administration of compounded sterile preparations (CSPs).
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Describe the four Compounded Sterile Preparation (CSP) Microbial Contamination Risk Levels.
- Low-Risk Level CSPsAseptic manipulations within an ISO Class 5 environment using three or fewer sterile products.
- Beyond Use Date (BUD): In the absence of passing sterility tests, CSPs in this level are stored not more than 48 hours at controlled room temperature, 14 days at cold temperature, and 45 days in a solid frozen state.
- Media-fill tests must be performed at least annually by compounding personnel.
- Medium-Risk Level CSPsThis level includes aseptic manipulations within an ISO Class 5 environment using prolonged and complex mixing and transfer, or more than three sterile products, or pooling ingredients from multiple sterile products to prepare multiple CSPs.
- Beyond Use Date (BUD): In the absence of passing sterility tests, CSPs are stored not more than 30 hours at controlled room temperature, 9 days at cold temperature, and 45 days in a solid frozen state.
- Media-fill tests must be performed at least annually by compounding personnel.
- High-Risk Level CSPsThere is a confirmed presence of non-sterile ingredients and devices, or confirmed or suspected exposure of sterile ingredients for more than one hour to air quality inferior to ISO Class 5 before final sterilization.
- Sterilization methods are verified to achieve sterility for the quantity and type of containers used.
- High-risk level CSPs meet allowable limits for bacterial endotoxins. They maintain acceptable strength and purity of ingredients and integrity of containers after sterilization.
- BUD: In the absence of passing sterility tests, high-risk level CSPs must be stored for not more than 24 hours at controlled room temperature, 3 days at cold temperature, and 45 days in solid frozen state.
- Media-fill tests must be performed at least semi-annually by compounding personnel.
- Immediate Use CSPsFully comply with specified criteria:
- Three or fewer sterile ingredients. More than three ingredients imply complex and/or chronic therapy, not simple immediate need therapy.
- Exclude hazardous drugs and radiopharmaceuticals. The hazardous drugs must be prepared using a suitable ISO Class 5 environment by properly trained, garbed, and gloved personnel.
- Require only simple aseptic measuring and transfer manipulations with no delays, interruptions, or direct contact contamination.
- Are labeled with correct patient identification, ingredients, and exact one-hour beyond use date and time, when the administration of the CSP is not either made or witnessed by the person who prepared it.
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What is the suggested (but not definite) time limit on administration time of Compounded Sterile Products (CSPs)?
- Most simple aseptic procedures take less than one hour. Administration begins within one hour from the start of the preparation. The one-hour limit until administration begins is intended to avoid microbial colonization that could cause harm or death to patients.
- While there is no limit on administration time specified by 797, it is cautioned that the longer the administration duration of microbially contaminated CSPs, the greater risk of harm or death to patients from contamination with viable microorganisms.
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What is the beyond use date (BUD) for multi-dose containers after the initial opening? For single-dose containers? What type of container does not allow storage?
- For multi-dose containers: 28 days unless otherwise specified by the manufacturer.
- For single-dose containers: 6 hours in ISO Class 5 or cleaner air unless otherwise specified by the manufacturer. However, if the air is worse than that found in ISO Class 5 air, then the time is shortened to only an hour.
- Single-dose ampules: do not allow storage of any left-over drug.
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For which categories must there be monitoring and written standard procedures when Compounding Sterile Products?
- Sterilization Methods
- Personnel Training & Evaluation in Aseptic Manipulation Skills
- Environmental Quality and Control
- Cleaning & Disinfecting the Sterile Compounding Areas
- Personnel Cleansing and Garbing
- Finished Preparation Checks and Tests
- Storage and Beyond-Use Dating
- Packaging and Transporting
- Patient or Caregiver Training
- Patient Monitoring & Adverse Events Reporting
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