USP 797 ACTUAL UPDATED Exam
Questions and CORRECT Answers
USP 797 - CORRECT ANSWER - United States Pharmacopeia chapter 797
Why was <797> developed? - CORRECT ANSWER - Means of addressing compounding
practices as a source of infections. (CSPs associated with recalls, patient injuries, deaths.)
1960s and 1970s the practice of pharmacy was evolving - CORRECT ANSWER -
Emphasis was placed on patient safety after patient injuries and deaths related to medication
delivery adn sterile compounding issues were reported.
What is a critical site? - CORRECT ANSWER - Any component or fluid pathway surface
or any opening providing a direct pathway between a sterile product & the environment.
Low Risk CSPs - CORRECT ANSWER - Compounded from sterile commercial drugs
using commercial sterile devices. Compounding occurs in ISO Class 5 environment (located
within ISO 7 Buffer Area). Only transferring, measuring, mixing manipulation. No more than 3
sterile products, max of 2 entries per sterile container.
Storage Requirements for Low-risk CSPs - CORRECT ANSWER - Controlled Room
Temp: 48 hour max
Cold temp: 14 day max
Solid Frozen state: 45 day max
Low Risk Examples - CORRECT ANSWER - -compounding piggybacks or hydration
fluids in a ISO 5 laminar flow hood (LVP with KCl and or vitamins)
-Dual Chamber parenteral nutrition container with no more than 2 additives
Low Risk Quality Assurance Procedures - CORRECT ANSWER - -annual media fill
-appropriate personnel garb
, -visual inspection
-does not require chemical analysis or pyrogen testing
Medium Risk CSPs - CORRECT ANSWER - -Multiple pooled sterile commercial
products for multiple patients or one patient multiple times.
-Complex aseptic manipulations- e.g. TPN (multiple ingredient CSPs), -prolonged compounding
period, administered over several days with no bacteriostatic agents added. ISO 5 PEC within
ISO 7 buffer area.
Storage Requirements for Medium-risk CSPs - CORRECT ANSWER - Controlled Room
Temp: 30 hours max
Cold temp: 9 days max
Solid Frozen State: 45 days max
Medium Risk Examples - CORRECT ANSWER - -TPN using manual or automated
devices
-filling device reservoirs with more than 3 sterile drug products and evacuation of air before
dispensing
-transfer of volumes from multiple ampules or vials into one or more final sterile contaienrs
Medium Risk Quality Assurance Procedures - CORRECT ANSWER - -more stringent
media fill
-bare hand and nonsterile gloves with only initial disinfection w/70% IPA
High Risk CSPs - CORRECT ANSWER - CSPs prepared from non-sterile ingredients or
with non-sterile devices. Prepared with sterile ingreidents, but exposed to poorer air quality than
ISO Class 5 for >1 hr.
Storage Requirements for High Risk CSPs - CORRECT ANSWER - Controlled Room
Temp: 24 hours max
Cold Temp: 3 days max
Questions and CORRECT Answers
USP 797 - CORRECT ANSWER - United States Pharmacopeia chapter 797
Why was <797> developed? - CORRECT ANSWER - Means of addressing compounding
practices as a source of infections. (CSPs associated with recalls, patient injuries, deaths.)
1960s and 1970s the practice of pharmacy was evolving - CORRECT ANSWER -
Emphasis was placed on patient safety after patient injuries and deaths related to medication
delivery adn sterile compounding issues were reported.
What is a critical site? - CORRECT ANSWER - Any component or fluid pathway surface
or any opening providing a direct pathway between a sterile product & the environment.
Low Risk CSPs - CORRECT ANSWER - Compounded from sterile commercial drugs
using commercial sterile devices. Compounding occurs in ISO Class 5 environment (located
within ISO 7 Buffer Area). Only transferring, measuring, mixing manipulation. No more than 3
sterile products, max of 2 entries per sterile container.
Storage Requirements for Low-risk CSPs - CORRECT ANSWER - Controlled Room
Temp: 48 hour max
Cold temp: 14 day max
Solid Frozen state: 45 day max
Low Risk Examples - CORRECT ANSWER - -compounding piggybacks or hydration
fluids in a ISO 5 laminar flow hood (LVP with KCl and or vitamins)
-Dual Chamber parenteral nutrition container with no more than 2 additives
Low Risk Quality Assurance Procedures - CORRECT ANSWER - -annual media fill
-appropriate personnel garb
, -visual inspection
-does not require chemical analysis or pyrogen testing
Medium Risk CSPs - CORRECT ANSWER - -Multiple pooled sterile commercial
products for multiple patients or one patient multiple times.
-Complex aseptic manipulations- e.g. TPN (multiple ingredient CSPs), -prolonged compounding
period, administered over several days with no bacteriostatic agents added. ISO 5 PEC within
ISO 7 buffer area.
Storage Requirements for Medium-risk CSPs - CORRECT ANSWER - Controlled Room
Temp: 30 hours max
Cold temp: 9 days max
Solid Frozen State: 45 days max
Medium Risk Examples - CORRECT ANSWER - -TPN using manual or automated
devices
-filling device reservoirs with more than 3 sterile drug products and evacuation of air before
dispensing
-transfer of volumes from multiple ampules or vials into one or more final sterile contaienrs
Medium Risk Quality Assurance Procedures - CORRECT ANSWER - -more stringent
media fill
-bare hand and nonsterile gloves with only initial disinfection w/70% IPA
High Risk CSPs - CORRECT ANSWER - CSPs prepared from non-sterile ingredients or
with non-sterile devices. Prepared with sterile ingreidents, but exposed to poorer air quality than
ISO Class 5 for >1 hr.
Storage Requirements for High Risk CSPs - CORRECT ANSWER - Controlled Room
Temp: 24 hours max
Cold Temp: 3 days max
