MPJE NJ – Compounding Latest Test
Questions with Complete Solutions.
Ante area" means ISO class ___ or better - Answer ISO 8
"Buffer area" means ISO class ___ area - Answer ISO 7
"Immediate use compounded sterile preparation" involve only simple aseptic measuring and
transfer manipulations of no more than ___ sterile non-hazardous commercial drug and
diagnostic radiopharmaceutical drug products - Answer 3
Administration of immediate use compounded sterile preparations shall begin within ___ hour
or preparation or the compounded sterile preparations shall be discharded - Answer 1 hour
"IOS class 5 air quality conditions" = air particle count is no greater than a total of ___ particles
of 0.5 meters and larger per cubic meter of air (___ particles per cubic foot) - Answer 3520
100
"IOS class 7 air quality conditions" = air particle count is no greater than a total of ___ particles
of 0.5 meters and larger per cubic meter of air (___ particles per cubic foot) - Answer
352,000
10,000
"IOS class 8 air quality conditions" = air particle count is no greater than a total of ___ particles
of 0.5 meters and larger per cubic meter of air (___ particles per cubic foot) - Answer
3,520,000
100,000
"low risk level compounded sterile preparation" involves only assembling, transferring ,
measuring, and mixing, using no more than ___ commercially manufactured sterile products,
and not more than ___ entries into one sterile container or package to make the compounded
sterile preparations - Answer 3
2
"medium risk level compounded sterile preparation" require multiple individual or small doses
of sterile products to be combined or pooled to prepare compounded sterile preparations that
will be administered either to ___ patients or to one patient on multiple occasion - Answer
multiple
, "high risk level compounded sterile preparation" from ___ ingredients or from ingredients that
are incorporated using non-sterile equipment before terminal sterilization - Answer non-
sterile ingredients
water-containing preparations that are stored for more than ___ hours before terminal
sterilization are also classified as high-risk level compounded sterile preparations - Answer 6
hours
A pharmacy permit holder who is approved to compound sterile preparations shall notify the
Board at least ___ days in advance of any remodeling, change of location, or change in size of
the pharmacy cleanroom - Answer 60 days
A pharmacy holding an institutional permit that intended to compound sterile preparations
using a *laminar airflow workbench or compounding aseptic isolator not located in a ___ area,
shall notify the Board at least ___ days* in advance of its intention - Answer buffer area
60 days
In cleanroom, air conditioned shall maintain a temperature of ___ to ___ Fahrenheit with an
ideal temperature of ___ degrees Fahrenheit - Answer 59 - 77 F
66 F
A pharmacy holding an *institutional pharmacy permit may utilize ISO class 5 laminar airflow
workbenches not located in a buffer area to prepare low-risk level compounded sterile
preparations* provided that the *administration of such preparations commences within ___
hours of preparation or as recommended by the manufacturer, whichever is less* - Answer
12 hours
A pharmacy holding an institutional pharmacy permit *may prepare non-hazardous immediate
use compounded sterile preparations outside an ISO class ___ workbench would harm the
patient*, including situations in which the patient experiences a sudden change in clinical status
- Answer 5
For sterile compounding,
- records are documented, at least ___ times daily, that appropriately controlled cold, controlled
freezer, and controlled room temperature
- such records shall be maintained for no less than ___ years - Answer twice daily
5 years
For personnel cleansing requirement for sterile compounding, personnel shall remove debris
from underneath fingernails using a nail cleaner under running warm water followed by
vigorous hand washing for at least ___ seconds - Answer 30 seconds
Questions with Complete Solutions.
Ante area" means ISO class ___ or better - Answer ISO 8
"Buffer area" means ISO class ___ area - Answer ISO 7
"Immediate use compounded sterile preparation" involve only simple aseptic measuring and
transfer manipulations of no more than ___ sterile non-hazardous commercial drug and
diagnostic radiopharmaceutical drug products - Answer 3
Administration of immediate use compounded sterile preparations shall begin within ___ hour
or preparation or the compounded sterile preparations shall be discharded - Answer 1 hour
"IOS class 5 air quality conditions" = air particle count is no greater than a total of ___ particles
of 0.5 meters and larger per cubic meter of air (___ particles per cubic foot) - Answer 3520
100
"IOS class 7 air quality conditions" = air particle count is no greater than a total of ___ particles
of 0.5 meters and larger per cubic meter of air (___ particles per cubic foot) - Answer
352,000
10,000
"IOS class 8 air quality conditions" = air particle count is no greater than a total of ___ particles
of 0.5 meters and larger per cubic meter of air (___ particles per cubic foot) - Answer
3,520,000
100,000
"low risk level compounded sterile preparation" involves only assembling, transferring ,
measuring, and mixing, using no more than ___ commercially manufactured sterile products,
and not more than ___ entries into one sterile container or package to make the compounded
sterile preparations - Answer 3
2
"medium risk level compounded sterile preparation" require multiple individual or small doses
of sterile products to be combined or pooled to prepare compounded sterile preparations that
will be administered either to ___ patients or to one patient on multiple occasion - Answer
multiple
, "high risk level compounded sterile preparation" from ___ ingredients or from ingredients that
are incorporated using non-sterile equipment before terminal sterilization - Answer non-
sterile ingredients
water-containing preparations that are stored for more than ___ hours before terminal
sterilization are also classified as high-risk level compounded sterile preparations - Answer 6
hours
A pharmacy permit holder who is approved to compound sterile preparations shall notify the
Board at least ___ days in advance of any remodeling, change of location, or change in size of
the pharmacy cleanroom - Answer 60 days
A pharmacy holding an institutional permit that intended to compound sterile preparations
using a *laminar airflow workbench or compounding aseptic isolator not located in a ___ area,
shall notify the Board at least ___ days* in advance of its intention - Answer buffer area
60 days
In cleanroom, air conditioned shall maintain a temperature of ___ to ___ Fahrenheit with an
ideal temperature of ___ degrees Fahrenheit - Answer 59 - 77 F
66 F
A pharmacy holding an *institutional pharmacy permit may utilize ISO class 5 laminar airflow
workbenches not located in a buffer area to prepare low-risk level compounded sterile
preparations* provided that the *administration of such preparations commences within ___
hours of preparation or as recommended by the manufacturer, whichever is less* - Answer
12 hours
A pharmacy holding an institutional pharmacy permit *may prepare non-hazardous immediate
use compounded sterile preparations outside an ISO class ___ workbench would harm the
patient*, including situations in which the patient experiences a sudden change in clinical status
- Answer 5
For sterile compounding,
- records are documented, at least ___ times daily, that appropriately controlled cold, controlled
freezer, and controlled room temperature
- such records shall be maintained for no less than ___ years - Answer twice daily
5 years
For personnel cleansing requirement for sterile compounding, personnel shall remove debris
from underneath fingernails using a nail cleaner under running warm water followed by
vigorous hand washing for at least ___ seconds - Answer 30 seconds
