NAPLEX: Compounding
Hazardous Non-sterile vs Sterile Compounded - Answer-Non-Sterile:
orals, topicals, nasals
Sterile:
IV drugs, eye drops, irrigations, TPN, injections
USP 795 - Answer-Non-sterile compounding
USP 797 - Answer-sterile compounding
USP 800 - Answer-hazardous drugs
API - Answer-Active Pharmaceutical Ingredient
Non-sterile Compounding Examples - Answer-Changing formulation
To avoid an excipient tht the pt can't have
A dose/form that isn't commercially available
,Add a flavor to a med
Sterile Compounding Examples - Answer-these MUST be done via sterile compounding:
anything w/blood
IV drugs
Eye, ear drops and irrigations, TPN
What makes a drug hazardous - Answer-Carcinogenic
Teratogenic
Causes organ toxicity at low doses
Genotoxic (DNA damage)
Ex. Chemo, hormones, transplant drugs
What is a Primary Engineering Control (PEC)? - Answer-The fume hood to do all the compounding in
What is a Secondary Engineering Control (SEC)? - Answer-It's the anti-room or room where the hood is
CSTD - Answer-closed-system transfer device
used to keep drugs contained inside the device to prevent spills/fumes leaking
Ventilated Compounding Enclosure (VCE) - Answer-Type of containment hood used for compounding
hormones
Non-Sterile Physical Space requirements - Answer-No storage on floor
Two types of water:
1. Potable (tap water)
, 2. Purified
Containment-PEC
Containment-SEC - Answer-Term used for a hood that is used to compound HDs and clean room for HDs
Hazardous Drug Space requirements - Answer-negative air pressure
There must be at least 12 ACPH (air changes per/h) in the buffer room
And at least 30 ACPH in the hood
Air Protocol - Answer-The lower the number the cleaner the air
ISO 5 = cleanest air (which is inside the hood where you stick your hands in to work)
ISO 7 = buffer room (SEC)
ISO 8 = ante-room
Where is the cleanest air? - Answer-Directly under the HEPA filter
HEPA Filters are: - Answer-> 99.97% effective at removing particles as small as 0.5 microns
Direct Compounding Area - Answer-A critical area within the ISO Class 5 (PEC) where critical sites are
exposed to unidirectional HEPA-filtered air, also known as first air.
How many inches away from the edge should you compound? - Answer-6 inches
What pressure is required in non-hazardous PECs? - Answer-positive
What is the BUD for CSPs made in an isolate? - Answer-12 hours
Hazardous Non-sterile vs Sterile Compounded - Answer-Non-Sterile:
orals, topicals, nasals
Sterile:
IV drugs, eye drops, irrigations, TPN, injections
USP 795 - Answer-Non-sterile compounding
USP 797 - Answer-sterile compounding
USP 800 - Answer-hazardous drugs
API - Answer-Active Pharmaceutical Ingredient
Non-sterile Compounding Examples - Answer-Changing formulation
To avoid an excipient tht the pt can't have
A dose/form that isn't commercially available
,Add a flavor to a med
Sterile Compounding Examples - Answer-these MUST be done via sterile compounding:
anything w/blood
IV drugs
Eye, ear drops and irrigations, TPN
What makes a drug hazardous - Answer-Carcinogenic
Teratogenic
Causes organ toxicity at low doses
Genotoxic (DNA damage)
Ex. Chemo, hormones, transplant drugs
What is a Primary Engineering Control (PEC)? - Answer-The fume hood to do all the compounding in
What is a Secondary Engineering Control (SEC)? - Answer-It's the anti-room or room where the hood is
CSTD - Answer-closed-system transfer device
used to keep drugs contained inside the device to prevent spills/fumes leaking
Ventilated Compounding Enclosure (VCE) - Answer-Type of containment hood used for compounding
hormones
Non-Sterile Physical Space requirements - Answer-No storage on floor
Two types of water:
1. Potable (tap water)
, 2. Purified
Containment-PEC
Containment-SEC - Answer-Term used for a hood that is used to compound HDs and clean room for HDs
Hazardous Drug Space requirements - Answer-negative air pressure
There must be at least 12 ACPH (air changes per/h) in the buffer room
And at least 30 ACPH in the hood
Air Protocol - Answer-The lower the number the cleaner the air
ISO 5 = cleanest air (which is inside the hood where you stick your hands in to work)
ISO 7 = buffer room (SEC)
ISO 8 = ante-room
Where is the cleanest air? - Answer-Directly under the HEPA filter
HEPA Filters are: - Answer-> 99.97% effective at removing particles as small as 0.5 microns
Direct Compounding Area - Answer-A critical area within the ISO Class 5 (PEC) where critical sites are
exposed to unidirectional HEPA-filtered air, also known as first air.
How many inches away from the edge should you compound? - Answer-6 inches
What pressure is required in non-hazardous PECs? - Answer-positive
What is the BUD for CSPs made in an isolate? - Answer-12 hours
