BRAINSCAPE1
BCSCP Exam with complete
solutions latest version
USP Supplements - CORRECT ANSWER-First published in Feb, official Aug 1.
Second published in June, official Dec 1.
Public Health Service Act - CORRECT ANSWER-Biologics License Application
(BLA)
351(k) pathway for biosimilars
Enforcement of USP Standards - CORRECT ANSWER-Responsibility of FDA and
other govt authorities.
USP has no role in enforcement
"About" - CORRECT ANSWER-Indicates a quantity within 10%
USP 795 bulk product expiration - CORRECT ANSWER-Compounder shall label
with date of receipt and assign a conservative expiration date not to exceed 3 yrs
795 BUD Nonaqueous formulations - CORRECT ANSWER-Not later than the time
remaining until the earliest expiration day of any API or 6 months
795 BUD Water Containing Oral Formulation - CORRECT ANSWER-Not later than
14 days when stored at controlled cold temp
795 BUD Water Containing Topical & Mucosal Liquids - CORRECT ANSWER-Not
later than 30 days
Compounding Documentation - CORRECT ANSWER-Records retained for the
same period of time required for any prescription under state law
May be a copy of the prescription
Should include Master Formulation Record and Compounding Record
ISO Class of Particulates in Room Air - CORRECT ANSWER-Limits are in
particulates of 5 um and larger per cubic meter
ISO 5 (class 100) 3,520
ISO 7 (class 10,000) 352,000
ISO 8 (class 100,000) 3,520,000
, BRAINSCAPE1
Low Risk CSP - CORRECT ANSWER-Not more than 3 packages & not more than 2
entries
48 hr at room temp (20-25)
14 days at cold temp (2-8)
45 days solid frozen state (-25 to -10)
Low Risk 12 hr BUD - CORRECT ANSWER-Non hazardous & radio
pharmaceuticals
Segregated compounding area - CORRECT ANSWER-ISO 5 PEC
No unsealed windows or doors that connect to outdoors or high traffic
Not adjacent to construction, warehouses, or food prep
Media-Fill Testing - CORRECT ANSWER-Annually
Simulates most challenging or stressful conditions
Completed without interruption
Soybean Casein Digest Medium (trypticase soy broth or tyrpticase soy agar)
Incubated 20-25 or 30-35 for min 14 days
Medium Risk CSP - CORRECT ANSWER-Multiple individual or small doses of
sterile products combined, more complex manipulation, with medium risk storage
(30 hours at room temp, 9 days refrigerated, 45 days frozen)
Ex: TPN, reservoirs
High Risk CSP - CORRECT ANSWER-Non sterile ingredients
Exposed to air quality worse than ISO 5 for more than 1 hour
Improperly garbed personnel
Nonsterilized water containing CSP stored >6 hrs before sterilizes
BUD 24 hr/3 days/45 days
Sterility tests not required unless batches of >25 units
Dry Heat Sterilization - CORRECT ANSWER-Done as a batch in an oven designed
for sterilization
Heat filtered air evenly distributed throughout chamber by blower
Requires higher temp and longer exposure than steam sterilization
Use only for materials that cannot he steam sterilized
Verified by BI Bacillus subtilis and temp sensing devices
Dry heat may be preformed at lower temp than may be effective for
depyrogenation
Depyrogenation by dry heat - CORRECT ANSWER-Used to render glassware it
containers free of pyrogens & viable microbes
30 minutes at 250
Verified using endotoxin challenge vials (ECVs) to verify cycle capable of
achieving 3-log reduction in endotoxin
, BRAINSCAPE1
High Risk CSP Prep - CORRECT ANSWER-All no sterile devices rinsed with
sterile, pyrogens free water then drained or dried immediately prior to high risk
compounding
Prefiltered by passing thru filter not larger than 1.2 um proceeding or during
filling to remove particulates
Sterilization with 0.2 um filter within PEC
High Risk Conditions - CORRECT ANSWER-Nonsterile bulk drugs that will be
terminally sterilized
Exposing sterile ingredients to worse than ISO 5 air for more than 1 hour
Mixing sterile ingredients in nonsterile devices
Assuming without evidence that bulk ingredients contain at least 95% of active
chemical & have not been contaminated or adulterated between uses
SDV & MDV BUD - CORRECT ANSWER-SDV within 1 hour if opened in worse than
ISO 5 air
SDV up to 6 hours punctured in ISO 5
Ampules may not be stored for any time period
MDV 28 days
HD handling - CORRECT ANSWER-Stored in negative pressure with at least 12
ACPH
Chemo gloves during receiving, distribution, stocking, inventorying, prep for
admin, and disposal
Low Volume HD Prep - CORRECT ANSWER-CSTD used in BSC or CACI in non
negative pressure room acceptable
Environmental sampling for HD - CORRECT ANSWER-Every 6 months
Surface wipe sampling of work area of PEC, countertops, areas adjacent to PEC,
floor directly under working area, and pt admin areas
Common markets: cyclophosphamide, ifosfamide, methotrexate, fluorouracil
Cyclophosphamide levels >1.00 ng pr cm2 found to cause human uptake
Radiopharmaceuticals - CORRECT ANSWER-Low risk - volume 100 mL or less for
single dose inj or not more than 30 mL taken from MDV
Shielded vials & syr in ISO 5 PEC located in ISO 8 and negative air flow
Direct visual inspection of CSP containing high concentrations of doses of
radioactivity conducted in accordance with ALARA
Allergen extracts - CORRECT ANSWER-SDV & MDV intradermal & sq injection
Not subject to personnel, environmental, storage requirements of CSPs
Sterilization Method Selection - CORRECT ANSWER-Selected method both
sterilized & maintains the strength, purity, quality, and packaging integrity of CSP
Verified whenever possible to achieve sterility in particular CSP
CSP ascertained to remain physically & chemically stable
Glass & metal devices covered tightly with aluminum foil and exposed to dry heat
(250 for 30 min) to achieve sterility & depyrogenation
BCSCP Exam with complete
solutions latest version
USP Supplements - CORRECT ANSWER-First published in Feb, official Aug 1.
Second published in June, official Dec 1.
Public Health Service Act - CORRECT ANSWER-Biologics License Application
(BLA)
351(k) pathway for biosimilars
Enforcement of USP Standards - CORRECT ANSWER-Responsibility of FDA and
other govt authorities.
USP has no role in enforcement
"About" - CORRECT ANSWER-Indicates a quantity within 10%
USP 795 bulk product expiration - CORRECT ANSWER-Compounder shall label
with date of receipt and assign a conservative expiration date not to exceed 3 yrs
795 BUD Nonaqueous formulations - CORRECT ANSWER-Not later than the time
remaining until the earliest expiration day of any API or 6 months
795 BUD Water Containing Oral Formulation - CORRECT ANSWER-Not later than
14 days when stored at controlled cold temp
795 BUD Water Containing Topical & Mucosal Liquids - CORRECT ANSWER-Not
later than 30 days
Compounding Documentation - CORRECT ANSWER-Records retained for the
same period of time required for any prescription under state law
May be a copy of the prescription
Should include Master Formulation Record and Compounding Record
ISO Class of Particulates in Room Air - CORRECT ANSWER-Limits are in
particulates of 5 um and larger per cubic meter
ISO 5 (class 100) 3,520
ISO 7 (class 10,000) 352,000
ISO 8 (class 100,000) 3,520,000
, BRAINSCAPE1
Low Risk CSP - CORRECT ANSWER-Not more than 3 packages & not more than 2
entries
48 hr at room temp (20-25)
14 days at cold temp (2-8)
45 days solid frozen state (-25 to -10)
Low Risk 12 hr BUD - CORRECT ANSWER-Non hazardous & radio
pharmaceuticals
Segregated compounding area - CORRECT ANSWER-ISO 5 PEC
No unsealed windows or doors that connect to outdoors or high traffic
Not adjacent to construction, warehouses, or food prep
Media-Fill Testing - CORRECT ANSWER-Annually
Simulates most challenging or stressful conditions
Completed without interruption
Soybean Casein Digest Medium (trypticase soy broth or tyrpticase soy agar)
Incubated 20-25 or 30-35 for min 14 days
Medium Risk CSP - CORRECT ANSWER-Multiple individual or small doses of
sterile products combined, more complex manipulation, with medium risk storage
(30 hours at room temp, 9 days refrigerated, 45 days frozen)
Ex: TPN, reservoirs
High Risk CSP - CORRECT ANSWER-Non sterile ingredients
Exposed to air quality worse than ISO 5 for more than 1 hour
Improperly garbed personnel
Nonsterilized water containing CSP stored >6 hrs before sterilizes
BUD 24 hr/3 days/45 days
Sterility tests not required unless batches of >25 units
Dry Heat Sterilization - CORRECT ANSWER-Done as a batch in an oven designed
for sterilization
Heat filtered air evenly distributed throughout chamber by blower
Requires higher temp and longer exposure than steam sterilization
Use only for materials that cannot he steam sterilized
Verified by BI Bacillus subtilis and temp sensing devices
Dry heat may be preformed at lower temp than may be effective for
depyrogenation
Depyrogenation by dry heat - CORRECT ANSWER-Used to render glassware it
containers free of pyrogens & viable microbes
30 minutes at 250
Verified using endotoxin challenge vials (ECVs) to verify cycle capable of
achieving 3-log reduction in endotoxin
, BRAINSCAPE1
High Risk CSP Prep - CORRECT ANSWER-All no sterile devices rinsed with
sterile, pyrogens free water then drained or dried immediately prior to high risk
compounding
Prefiltered by passing thru filter not larger than 1.2 um proceeding or during
filling to remove particulates
Sterilization with 0.2 um filter within PEC
High Risk Conditions - CORRECT ANSWER-Nonsterile bulk drugs that will be
terminally sterilized
Exposing sterile ingredients to worse than ISO 5 air for more than 1 hour
Mixing sterile ingredients in nonsterile devices
Assuming without evidence that bulk ingredients contain at least 95% of active
chemical & have not been contaminated or adulterated between uses
SDV & MDV BUD - CORRECT ANSWER-SDV within 1 hour if opened in worse than
ISO 5 air
SDV up to 6 hours punctured in ISO 5
Ampules may not be stored for any time period
MDV 28 days
HD handling - CORRECT ANSWER-Stored in negative pressure with at least 12
ACPH
Chemo gloves during receiving, distribution, stocking, inventorying, prep for
admin, and disposal
Low Volume HD Prep - CORRECT ANSWER-CSTD used in BSC or CACI in non
negative pressure room acceptable
Environmental sampling for HD - CORRECT ANSWER-Every 6 months
Surface wipe sampling of work area of PEC, countertops, areas adjacent to PEC,
floor directly under working area, and pt admin areas
Common markets: cyclophosphamide, ifosfamide, methotrexate, fluorouracil
Cyclophosphamide levels >1.00 ng pr cm2 found to cause human uptake
Radiopharmaceuticals - CORRECT ANSWER-Low risk - volume 100 mL or less for
single dose inj or not more than 30 mL taken from MDV
Shielded vials & syr in ISO 5 PEC located in ISO 8 and negative air flow
Direct visual inspection of CSP containing high concentrations of doses of
radioactivity conducted in accordance with ALARA
Allergen extracts - CORRECT ANSWER-SDV & MDV intradermal & sq injection
Not subject to personnel, environmental, storage requirements of CSPs
Sterilization Method Selection - CORRECT ANSWER-Selected method both
sterilized & maintains the strength, purity, quality, and packaging integrity of CSP
Verified whenever possible to achieve sterility in particular CSP
CSP ascertained to remain physically & chemically stable
Glass & metal devices covered tightly with aluminum foil and exposed to dry heat
(250 for 30 min) to achieve sterility & depyrogenation
