USP 797 Exam 2025 Questions and
Answers
USP 797 - ANSWER✔✔-United States Pharmacopeia chapter 797
Why was <797> developed? - 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 - 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? - ANSWER✔✔-Any component or fluid pathway surface or any
opening providing a direct pathway between a sterile product & the environment.
Low Risk CSPs - 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.
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, Storage Requirements for Low-risk CSPs - ANSWER✔✔-Controlled Room Temp: 48
hour max
Cold temp: 14 day max
Solid Frozen state: 45 day max
Low Risk Examples - 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 - ANSWER✔✔--annual media fill
-appropriate personnel garb
-visual inspection
-does not require chemical analysis or pyrogen testing
Medium Risk CSPs - 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 - ANSWER✔✔-Controlled Room Temp:
30 hours max
COPYRIGHT © 2025 ALL RIGHTS RESERVED
Answers
USP 797 - ANSWER✔✔-United States Pharmacopeia chapter 797
Why was <797> developed? - 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 - 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? - ANSWER✔✔-Any component or fluid pathway surface or any
opening providing a direct pathway between a sterile product & the environment.
Low Risk CSPs - 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.
COPYRIGHT © 2025 ALL RIGHTS RESERVED
, Storage Requirements for Low-risk CSPs - ANSWER✔✔-Controlled Room Temp: 48
hour max
Cold temp: 14 day max
Solid Frozen state: 45 day max
Low Risk Examples - 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 - ANSWER✔✔--annual media fill
-appropriate personnel garb
-visual inspection
-does not require chemical analysis or pyrogen testing
Medium Risk CSPs - 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 - ANSWER✔✔-Controlled Room Temp:
30 hours max
COPYRIGHT © 2025 ALL RIGHTS RESERVED
