USP 797 EXAM QUESTIONS WITH CORRECT
ANSWERS
USP 797-ANSWER Chapter 797 of the US Pharmacopoeia
For what reason was <797> created? ANSWER ways to deal with the
compounding techniques as an infection source. (CSPs linked to patient harm,
recalls, and fatalities.)
The practice of pharmacy was changing in the 1960s and 1970s. ANSWER
Following reports of patient injuries and fatalities associated with medicine
delivery and sterile compounding problems, a focus on patient safety was
established.
A vital site is what? ANSWER Any part, fluid channel surface, or aperture that
serves as a direct conduit between the environment and a sterile product.
ANSWER: Low Risk CSPs manufactured utilising commercial sterile
equipment from sterile pharmaceuticals. Compounding takes place in an ISO
Class 5 environment, which is part of the ISO 7 Buffer Area. just manipulating
by transferring, measuring, and mixing. A maximum of two entries per sterile
container and no more than three sterile products.
Storage Needs for CSPs at Low Risk - ANSWER Room Under Control
Maximum temperature: 48 hours
Maximum cold temperature: 14 days
Solid frozen state: no more than 45 days
Examples of Low Risk The solution is to compound piggybacks or hydration
fluids (LVP with KCl and/or vitamins) in an ISO 5 laminar flow hood.
-A parenteral feeding container with two chambers and no more than two
ingredients
, Procedures for Low Risk Quality Assurance: ANSWER, yearly media fill, and
proper staff attire
-visual examination -no pyrogen testing or chemical analysis is necessary
ANSWER: Medium Risk CSPs: Several pooled sterile commercial items for
one patient or several patients.
Intricate aseptic procedures, such as TPN (many ingredient CSPs), -long
compounding time, given over a number of days without the addition of
bacteriostatic drugs. ISO 5 PEC inside the buffer zone of ISO 7.
Storage Needs for CSPs at Medium Risk - ANSWER Room Under Control
Temperature: maximum of 30 hours
Maximum cold temperature: 9 days
Solid Frozen State: no more than 45 days
Examples of Medium Risk: ANSWER-TPN with automated or manual devices
-transferring quantities from several ampules or vials into one or more final
sterile containers; -filling device reservoirs with more than three sterile
medicinal items; and -exhausting air before dispensing
Methods for Medium Risk Quality Assurance: ANSWER - stricter media fill -
nonsterile gloves and bare hands with only initial cleaning with 70% IPA
High Risk CSPs: ANSWER CSPs made with non-sterile equipment or non-
sterile substances. prepared using sterile ingredients, but spent more than an
hour in air that was lower quality than ISO Class 5.
Storage Needs for High-Risk CSPs: A Solution Maximum Controlled Room
Temperature: 24 hours
Cold temperature: no more than three days
Solid Frozen State: no more than 45 days
Examples of high risk include: ANSWER - nonsterile bulk and nutrient
powders that will be sterilised (such as glutamine and morphine) -sterile
ingredients in nonsterile containers - bladder irrigations made from bulk powder
- low and medium risk, which begin and maintain sterility; and high risk, which
requires a nonsterile component to be made sterile.
ANSWERS
USP 797-ANSWER Chapter 797 of the US Pharmacopoeia
For what reason was <797> created? ANSWER ways to deal with the
compounding techniques as an infection source. (CSPs linked to patient harm,
recalls, and fatalities.)
The practice of pharmacy was changing in the 1960s and 1970s. ANSWER
Following reports of patient injuries and fatalities associated with medicine
delivery and sterile compounding problems, a focus on patient safety was
established.
A vital site is what? ANSWER Any part, fluid channel surface, or aperture that
serves as a direct conduit between the environment and a sterile product.
ANSWER: Low Risk CSPs manufactured utilising commercial sterile
equipment from sterile pharmaceuticals. Compounding takes place in an ISO
Class 5 environment, which is part of the ISO 7 Buffer Area. just manipulating
by transferring, measuring, and mixing. A maximum of two entries per sterile
container and no more than three sterile products.
Storage Needs for CSPs at Low Risk - ANSWER Room Under Control
Maximum temperature: 48 hours
Maximum cold temperature: 14 days
Solid frozen state: no more than 45 days
Examples of Low Risk The solution is to compound piggybacks or hydration
fluids (LVP with KCl and/or vitamins) in an ISO 5 laminar flow hood.
-A parenteral feeding container with two chambers and no more than two
ingredients
, Procedures for Low Risk Quality Assurance: ANSWER, yearly media fill, and
proper staff attire
-visual examination -no pyrogen testing or chemical analysis is necessary
ANSWER: Medium Risk CSPs: Several pooled sterile commercial items for
one patient or several patients.
Intricate aseptic procedures, such as TPN (many ingredient CSPs), -long
compounding time, given over a number of days without the addition of
bacteriostatic drugs. ISO 5 PEC inside the buffer zone of ISO 7.
Storage Needs for CSPs at Medium Risk - ANSWER Room Under Control
Temperature: maximum of 30 hours
Maximum cold temperature: 9 days
Solid Frozen State: no more than 45 days
Examples of Medium Risk: ANSWER-TPN with automated or manual devices
-transferring quantities from several ampules or vials into one or more final
sterile containers; -filling device reservoirs with more than three sterile
medicinal items; and -exhausting air before dispensing
Methods for Medium Risk Quality Assurance: ANSWER - stricter media fill -
nonsterile gloves and bare hands with only initial cleaning with 70% IPA
High Risk CSPs: ANSWER CSPs made with non-sterile equipment or non-
sterile substances. prepared using sterile ingredients, but spent more than an
hour in air that was lower quality than ISO Class 5.
Storage Needs for High-Risk CSPs: A Solution Maximum Controlled Room
Temperature: 24 hours
Cold temperature: no more than three days
Solid Frozen State: no more than 45 days
Examples of high risk include: ANSWER - nonsterile bulk and nutrient
powders that will be sterilised (such as glutamine and morphine) -sterile
ingredients in nonsterile containers - bladder irrigations made from bulk powder
- low and medium risk, which begin and maintain sterility; and high risk, which
requires a nonsterile component to be made sterile.
