USP 797 - Exam 1 – Parenteral questions and answers
already passed
1. The was established in 1820; is the official pub- USP
lic standards-setting authority for:
- All prescription & OTC medicines
- Dietary supplements
- Other healthcare products
manufactured & sold in the US
2. The mission of the is to improve global USP
health through public standards & related
programs that help ensure the quality,
safety, & benefit of medicine & food.
3. USP chapter sets minimum practice 797
standards to help ensure that sterile
preparations are of the high- est quality;
guidelines were developed in 2008; the
current guidelines were implemented in
11/2023
4. USP 797 separates sterile preparations from non-ster- sterility
ile preparations by requiring the maintenance of
when compounding exclusively with
sterile in- gredients & components & the
achievement of this when compounding with
non sterile ingredients & components.
5. T/F: The goal of USP 797 is to prevent harm to patients True
that could result from:
- Microbial contamination
,USP 797 - Exam 1 – Parenteral questions and answers
already passed
- Excessive bacterial endotoxins
- Variability in intended strength
- Physical & chemical incompatibilities
,USP 797 - Exam 1 – Parenteral questions and answers
already passed
- Unintended chemical and physical
contaminants
- Ingredients of inappropriate quality in CSPs
personnel; places; clinical
6. USP 797 applies to all who prepare CSPs &
administration
to all where they are prepared to
ensure that all patients are treated with
sterile, safe, & accurate preparations; does
NOT apply to of CSPs. True
7. T/F: One situation that exemplifies the NECC = New England
importance of USP 797 is a multistage Compounding Center in
outbreak of fungal meningitis & other Framingham, Massachu-
infections from tainted NECC contaminated setts
steroid injections reported in 2012.
Compounded sterile
products (CSPs)
8. are compounded biologics, drugs,
nutri- ents, & radiopharmaceuticals;
manufactured sterile products that are
either prepared strictly according to the
instructions in the package insert or
prepared differently than published in such
labeling
9. What are the 3 current categories of CSPs? - Category 1
-Category 2
-Category 3
10. Risk classifications for CSPs represent the
potential risk to patients as a result of considering
already passed
1. The was established in 1820; is the official pub- USP
lic standards-setting authority for:
- All prescription & OTC medicines
- Dietary supplements
- Other healthcare products
manufactured & sold in the US
2. The mission of the is to improve global USP
health through public standards & related
programs that help ensure the quality,
safety, & benefit of medicine & food.
3. USP chapter sets minimum practice 797
standards to help ensure that sterile
preparations are of the high- est quality;
guidelines were developed in 2008; the
current guidelines were implemented in
11/2023
4. USP 797 separates sterile preparations from non-ster- sterility
ile preparations by requiring the maintenance of
when compounding exclusively with
sterile in- gredients & components & the
achievement of this when compounding with
non sterile ingredients & components.
5. T/F: The goal of USP 797 is to prevent harm to patients True
that could result from:
- Microbial contamination
,USP 797 - Exam 1 – Parenteral questions and answers
already passed
- Excessive bacterial endotoxins
- Variability in intended strength
- Physical & chemical incompatibilities
,USP 797 - Exam 1 – Parenteral questions and answers
already passed
- Unintended chemical and physical
contaminants
- Ingredients of inappropriate quality in CSPs
personnel; places; clinical
6. USP 797 applies to all who prepare CSPs &
administration
to all where they are prepared to
ensure that all patients are treated with
sterile, safe, & accurate preparations; does
NOT apply to of CSPs. True
7. T/F: One situation that exemplifies the NECC = New England
importance of USP 797 is a multistage Compounding Center in
outbreak of fungal meningitis & other Framingham, Massachu-
infections from tainted NECC contaminated setts
steroid injections reported in 2012.
Compounded sterile
products (CSPs)
8. are compounded biologics, drugs,
nutri- ents, & radiopharmaceuticals;
manufactured sterile products that are
either prepared strictly according to the
instructions in the package insert or
prepared differently than published in such
labeling
9. What are the 3 current categories of CSPs? - Category 1
-Category 2
-Category 3
10. Risk classifications for CSPs represent the
potential risk to patients as a result of considering
