USP 797 Questions well answered
100% correct already passed
1.3 Immediate-Use CSPs (memorize asterisks) - correct answer ✔✔When all of the following
conditions are met, compounding of CSPs for direct and immediate administration is not subject
to the requirements for Category 1, Category 2, or Category 3 CSPs:
1. Aseptic techniques, processes, and procedures are followed, and written SOPs are in place to
minimize the potential for contact with nonsterile surfaces, introduction of particulate matter or
biological fluids, and mix-ups with other conventionally manufactured products or CSPs.
2. Personnel are trained and demonstrate competency in aseptic processes as they relate to
assigned tasks and the facility's SOPs.
3. The preparation is performed in accordance with evidence-based information for physical and
chemical compatibility of the drugs (e.g., approved labeling, stability and compatibility studies).
* 4. The preparation involves not more than 3 different sterile products.
5. Any unused starting component from a single-dose container must be discarded after
preparation is complete. Single-dose containers must not be used for more than one patient.
* 6. Administration begins within 4 h following the start of preparation. If administration has not
begun within 4 h following the start of preparation, it must be promptly, appropriately, and
safely discarded.
7. Unless directly administered by the person who prepared it or administration is witnessed by
the preparer, the CSP must be labeled with the names and amounts of all active ingredients, the
name or initials of the person who prepared the preparation, and the 4-h time period within
which administration must begin.
2.1 Knowledge of Competency of Core Skills - correct answer ✔✔*initially and every 12 months
• Hand hygiene
• Garbing
• Cleaning and disinfection
• Calculations, measuring, and mixing
,• Aseptic technique
• Achieving and/or maintaining sterility (and apyrogenicity if compounding with nonsterile
components)
• Use of equipment
• Documentation of the compounding process (e.g., master formulation and compounding
records)
• Principles of high-efficiency particulate air (HEPA)-filtered unidirectional airflow within the ISO
Class 5 area
• Proper use of PECs
• Principles of movement of materials and personnel within the compounding area
2.2 Competency in Hand Hygiene and Garbing - correct answer ✔✔Category 1 CSP
- initially : 3 consecutive GFS with 0 CFU
- subsequently 1 GFS every 6 months
Category 2 CSP
- initially : 3 consecutive GFS with 0 CFU
- subsequently 1 GFS every 6 months
Category 3 CSP
- initially : 3 consecutive GFS with 0 CFU
- subsequently 1 GFS every 3 months
If you don't mix, but oversee, you need to test:
- initially : 3 consecutive GFS with 0 CFU
- every 12 months
, incubate media plates at 30 - 35 C for at least 48h and 20 - 25 C for at least 5 additional days.
Documentation must at a minimum include 1) the name of the person evaluated, 2) evaluation
date and time, 3) media and components used including their manufacturer or supplier, 4)
expiration dates and lot numbers, 5) starting temperature for each interval of incubation, 6)
dates of incubation, 7) the results, and 8) the names or other identification of the observer and
the person who reads and documents the results. No microbial identification required.
2.3 Competency in Aseptic Technique - correct answer ✔✔Media fill test -> post-GFS -> Surface
sampling of DCA
A failure in the media fill, gloved fingertip and thumb sampling, or surface sample constitutes an
overall failure of the aseptic manipulation competency
Category 1 and 2 CSP
- initially and every 6 months: medial fill container: no turbidity; GFS ≤3; surface sampling of the
direct compounding area must occur in accordance with the requirements in 6.3 Monitoring
Surfaces for Viable Particles.
Category 3 CSP
- initially and every 3 months
Medial Fill containers: incubate media containers at 20 - 25 C then 30 - 35 C for at least 7 days.
GFS: incubate media plates at 30 - 35 C for at least 48h and 20 - 25 C for at least 5 additional
days.
Documentation must at a minimum include 1) the name of the person evaluated, 2) evaluation
date and time, 3) media and components used including their manufacturer or supplier, 4)
expiration dates and lot numbers, 5) starting temperature for each interval of incubation, 6)
100% correct already passed
1.3 Immediate-Use CSPs (memorize asterisks) - correct answer ✔✔When all of the following
conditions are met, compounding of CSPs for direct and immediate administration is not subject
to the requirements for Category 1, Category 2, or Category 3 CSPs:
1. Aseptic techniques, processes, and procedures are followed, and written SOPs are in place to
minimize the potential for contact with nonsterile surfaces, introduction of particulate matter or
biological fluids, and mix-ups with other conventionally manufactured products or CSPs.
2. Personnel are trained and demonstrate competency in aseptic processes as they relate to
assigned tasks and the facility's SOPs.
3. The preparation is performed in accordance with evidence-based information for physical and
chemical compatibility of the drugs (e.g., approved labeling, stability and compatibility studies).
* 4. The preparation involves not more than 3 different sterile products.
5. Any unused starting component from a single-dose container must be discarded after
preparation is complete. Single-dose containers must not be used for more than one patient.
* 6. Administration begins within 4 h following the start of preparation. If administration has not
begun within 4 h following the start of preparation, it must be promptly, appropriately, and
safely discarded.
7. Unless directly administered by the person who prepared it or administration is witnessed by
the preparer, the CSP must be labeled with the names and amounts of all active ingredients, the
name or initials of the person who prepared the preparation, and the 4-h time period within
which administration must begin.
2.1 Knowledge of Competency of Core Skills - correct answer ✔✔*initially and every 12 months
• Hand hygiene
• Garbing
• Cleaning and disinfection
• Calculations, measuring, and mixing
,• Aseptic technique
• Achieving and/or maintaining sterility (and apyrogenicity if compounding with nonsterile
components)
• Use of equipment
• Documentation of the compounding process (e.g., master formulation and compounding
records)
• Principles of high-efficiency particulate air (HEPA)-filtered unidirectional airflow within the ISO
Class 5 area
• Proper use of PECs
• Principles of movement of materials and personnel within the compounding area
2.2 Competency in Hand Hygiene and Garbing - correct answer ✔✔Category 1 CSP
- initially : 3 consecutive GFS with 0 CFU
- subsequently 1 GFS every 6 months
Category 2 CSP
- initially : 3 consecutive GFS with 0 CFU
- subsequently 1 GFS every 6 months
Category 3 CSP
- initially : 3 consecutive GFS with 0 CFU
- subsequently 1 GFS every 3 months
If you don't mix, but oversee, you need to test:
- initially : 3 consecutive GFS with 0 CFU
- every 12 months
, incubate media plates at 30 - 35 C for at least 48h and 20 - 25 C for at least 5 additional days.
Documentation must at a minimum include 1) the name of the person evaluated, 2) evaluation
date and time, 3) media and components used including their manufacturer or supplier, 4)
expiration dates and lot numbers, 5) starting temperature for each interval of incubation, 6)
dates of incubation, 7) the results, and 8) the names or other identification of the observer and
the person who reads and documents the results. No microbial identification required.
2.3 Competency in Aseptic Technique - correct answer ✔✔Media fill test -> post-GFS -> Surface
sampling of DCA
A failure in the media fill, gloved fingertip and thumb sampling, or surface sample constitutes an
overall failure of the aseptic manipulation competency
Category 1 and 2 CSP
- initially and every 6 months: medial fill container: no turbidity; GFS ≤3; surface sampling of the
direct compounding area must occur in accordance with the requirements in 6.3 Monitoring
Surfaces for Viable Particles.
Category 3 CSP
- initially and every 3 months
Medial Fill containers: incubate media containers at 20 - 25 C then 30 - 35 C for at least 7 days.
GFS: incubate media plates at 30 - 35 C for at least 48h and 20 - 25 C for at least 5 additional
days.
Documentation must at a minimum include 1) the name of the person evaluated, 2) evaluation
date and time, 3) media and components used including their manufacturer or supplier, 4)
expiration dates and lot numbers, 5) starting temperature for each interval of incubation, 6)
