Rxprep: Compounding I Questions and Answers (Verified !!)
Hydroxyurea powder is used to compound an oral solution. Which USP standard would
apply
usp 797, usp795, usp800, - answer- Usp 795 ( oral solution since it is considered a
non-sterile compound)
Usp800( hydroxyurea is hazardous drug)
Reason when it is not acceptable to compound a drug?
1)adding chicken flavor to a med for a dog
2) compounding propxyphene capsules which was withdrawn from the market due to
cardiac toxicity
3)encapsulating naltrexone powder with hydroxymethylcellulose capsule for a vegan
patient
4) using adderal tablet to compound an amphetamine//dextroamphetamine oral solution
for a pediatric patient who can't swallow pills. Desired dose was not commercially
available
5) compounding a unique formulation of a multivitamin for a female patient - answer- 2)
compounding propxyphene capsules which was withdrawn from the market due to
cardiac toxicity
If the same product is commercially available
withdrawn from market for safety reasons
Which of the following is correct regarding labeling , storage and stability of non sterile
compounded products?
1)Store all bulk products off the floor and rotate so that the nearest expiration date is in
front and used first
2)BUD must not be later than expiration date on the container of any of the container of
any of the individual components
3)a statement that the product has been compounded by pharmacy must be placed on
the label of container
4)BUD for nonAQ is the earliest expiration date of any API for 12 months or whichever
comes first
5)guidelines for handling and storing hazardous drug are provided by USP800 -
answer- 1)Store all bulk products off the floor and rotate so that the nearest expiration
date is in front and used first
2)BUD must not be later than expiration date on the container of any of the container of
any of the individual components
3)a statement that the product has been compounded by pharmacy must be placed on
the label of container
5)guidelines for handling and storing hazardous drug are provided by USP800
, 4)BUD for nonAQ is the earliest expiration date of any API for 12 months or whichever
comes first IS NOT CORRECT because BUD for NONAQ is not 12 months but 6
MONTHS.
Compounding allergen immunotherapy that is administered to a patient IM. Which of the
following USP standards should the pharmacist follow?
USP797
USP795 - answer- USP797- for sterile compounding since injectables must be sterile
which preparation don't need sterile compounding?
1) point of care activation system such as ADD-Vantage vial/bag and premixed ready to
use bags
2) IV bags containing PTN
3) Tissues soak for organ transplants
4)IV bags with 3 individual components or less
5)Opthalmics and inhalations that are not prepackaged and must be prepared -
answer- 1) point of care activation system such as ADD-Vantage vial/bag and premixed
ready to use bags
since these are premixed/ready to use which are commercially available closed systems
that only require labeling.
Laminar air flow in sterile compounding means the following:
airflow is horizontal and turbulent
airflow is vertical and turbulent
airflow is unidirectional
airflow is turbulent - answer- airflow is unidirectional
- means in one direction only, in either horizontal or vertical. The air existing the hepa
filter is called first air and is nearly particle free, to keep it that way, only critical
compounding manipulations such as inserting the drug into IV bag with a syringe is
permitted in the first air zone.
which of the following is not a type of primary engineering control(ISO 5 air required)
used for compounding?
biological safety cabinet
segregated compounding area
compounding aseptic isolator
compounding aseptic containment isolator
laminar airflow workbench - answer- segregated compounding area has unclassified
airt
Hydroxyurea powder is used to compound an oral solution. Which USP standard would
apply
usp 797, usp795, usp800, - answer- Usp 795 ( oral solution since it is considered a
non-sterile compound)
Usp800( hydroxyurea is hazardous drug)
Reason when it is not acceptable to compound a drug?
1)adding chicken flavor to a med for a dog
2) compounding propxyphene capsules which was withdrawn from the market due to
cardiac toxicity
3)encapsulating naltrexone powder with hydroxymethylcellulose capsule for a vegan
patient
4) using adderal tablet to compound an amphetamine//dextroamphetamine oral solution
for a pediatric patient who can't swallow pills. Desired dose was not commercially
available
5) compounding a unique formulation of a multivitamin for a female patient - answer- 2)
compounding propxyphene capsules which was withdrawn from the market due to
cardiac toxicity
If the same product is commercially available
withdrawn from market for safety reasons
Which of the following is correct regarding labeling , storage and stability of non sterile
compounded products?
1)Store all bulk products off the floor and rotate so that the nearest expiration date is in
front and used first
2)BUD must not be later than expiration date on the container of any of the container of
any of the individual components
3)a statement that the product has been compounded by pharmacy must be placed on
the label of container
4)BUD for nonAQ is the earliest expiration date of any API for 12 months or whichever
comes first
5)guidelines for handling and storing hazardous drug are provided by USP800 -
answer- 1)Store all bulk products off the floor and rotate so that the nearest expiration
date is in front and used first
2)BUD must not be later than expiration date on the container of any of the container of
any of the individual components
3)a statement that the product has been compounded by pharmacy must be placed on
the label of container
5)guidelines for handling and storing hazardous drug are provided by USP800
, 4)BUD for nonAQ is the earliest expiration date of any API for 12 months or whichever
comes first IS NOT CORRECT because BUD for NONAQ is not 12 months but 6
MONTHS.
Compounding allergen immunotherapy that is administered to a patient IM. Which of the
following USP standards should the pharmacist follow?
USP797
USP795 - answer- USP797- for sterile compounding since injectables must be sterile
which preparation don't need sterile compounding?
1) point of care activation system such as ADD-Vantage vial/bag and premixed ready to
use bags
2) IV bags containing PTN
3) Tissues soak for organ transplants
4)IV bags with 3 individual components or less
5)Opthalmics and inhalations that are not prepackaged and must be prepared -
answer- 1) point of care activation system such as ADD-Vantage vial/bag and premixed
ready to use bags
since these are premixed/ready to use which are commercially available closed systems
that only require labeling.
Laminar air flow in sterile compounding means the following:
airflow is horizontal and turbulent
airflow is vertical and turbulent
airflow is unidirectional
airflow is turbulent - answer- airflow is unidirectional
- means in one direction only, in either horizontal or vertical. The air existing the hepa
filter is called first air and is nearly particle free, to keep it that way, only critical
compounding manipulations such as inserting the drug into IV bag with a syringe is
permitted in the first air zone.
which of the following is not a type of primary engineering control(ISO 5 air required)
used for compounding?
biological safety cabinet
segregated compounding area
compounding aseptic isolator
compounding aseptic containment isolator
laminar airflow workbench - answer- segregated compounding area has unclassified
airt
