Final Exam USP 797 questions and
answers graded A+
What does USP stand for? - correct answer ✔✔United States Pharmacopeia
What is the USP? - correct answer ✔✔It is a non-government, non-profit organization which is
designed to create standards on patient safety, healthcare information, and verification of
products
What is USP 797? - correct answer ✔✔Specifically refers to sterile compounding of
pharmaceuticals (i.e. IV admixtures) in order to prevent patient harm
Who does USP 797 affect? - correct answer ✔✔"Health care institutions, pharmacies,
physician's practice facilities and other facilities in which compounded sterile preparations
(CSPs) are prepared, stored and dispensed"
What are the risk level classifications of compounded sterile preparations? - correct answer
✔✔Risk level classifications are divided up depending on how much manipulation to the
admixture is involved
- Immediate Use CSPs
- Low-risk level
- Low-risk level with 12 hour or less BUD - a subsection of low risk level
- Medium-risk level
- High-risk level
What is required for immediate use CSPs? - correct answer ✔✔Exempt from all requirements in
797
, - Only simple aseptic measuring and transfer are needed
- No more than (NMT) 3 sterile non-hazardous drugs
- NMT 2 entries in one container
- No delays/interruptions
- No contact contamination of ingredients or critical sites
- Dose must be labeled if not administered by the preparer
- Administration must begin within 1 hour after the start of preparation
- Dose must be discarded if administration has not begun within 1 hour after the start of
preparation (no storing. no recycling)
What are examples of when immediate use CSPs would be used? - correct answer ✔✔At a
patient's bedside
In an ambulance
In an ER
In a war zone
In a code situation
What are required for low-risk level sterile compounded preparations? - correct answer
✔✔CSPs are compounded from sterile commercial drugs using commercial sterile devices
- Compounding done in ISO class 5 (100) environment at all times
- Procedure involve only a few closed system, basic, simple aseptic transfers and manipulations
- "Three or fewer sterile products and entries into any container"
What are examples of low-risk level sterile compounded preparations? - correct answer
✔✔Using sterile needles and syringes to transfer sterile drugs from manufacturers original
packing (vials, ampules)
answers graded A+
What does USP stand for? - correct answer ✔✔United States Pharmacopeia
What is the USP? - correct answer ✔✔It is a non-government, non-profit organization which is
designed to create standards on patient safety, healthcare information, and verification of
products
What is USP 797? - correct answer ✔✔Specifically refers to sterile compounding of
pharmaceuticals (i.e. IV admixtures) in order to prevent patient harm
Who does USP 797 affect? - correct answer ✔✔"Health care institutions, pharmacies,
physician's practice facilities and other facilities in which compounded sterile preparations
(CSPs) are prepared, stored and dispensed"
What are the risk level classifications of compounded sterile preparations? - correct answer
✔✔Risk level classifications are divided up depending on how much manipulation to the
admixture is involved
- Immediate Use CSPs
- Low-risk level
- Low-risk level with 12 hour or less BUD - a subsection of low risk level
- Medium-risk level
- High-risk level
What is required for immediate use CSPs? - correct answer ✔✔Exempt from all requirements in
797
, - Only simple aseptic measuring and transfer are needed
- No more than (NMT) 3 sterile non-hazardous drugs
- NMT 2 entries in one container
- No delays/interruptions
- No contact contamination of ingredients or critical sites
- Dose must be labeled if not administered by the preparer
- Administration must begin within 1 hour after the start of preparation
- Dose must be discarded if administration has not begun within 1 hour after the start of
preparation (no storing. no recycling)
What are examples of when immediate use CSPs would be used? - correct answer ✔✔At a
patient's bedside
In an ambulance
In an ER
In a war zone
In a code situation
What are required for low-risk level sterile compounded preparations? - correct answer
✔✔CSPs are compounded from sterile commercial drugs using commercial sterile devices
- Compounding done in ISO class 5 (100) environment at all times
- Procedure involve only a few closed system, basic, simple aseptic transfers and manipulations
- "Three or fewer sterile products and entries into any container"
What are examples of low-risk level sterile compounded preparations? - correct answer
✔✔Using sterile needles and syringes to transfer sterile drugs from manufacturers original
packing (vials, ampules)
