USP 797 2025/2026 Exam Questions with
100% Correct Answers | Latest Update
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.
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
100% Correct Answers | Latest Update
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.
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
