10/1/25, 11:46 AM BCSCP Exam (updated 2025) Questions & Answers | Latest Already Graded A+ UPDATE 2025|2026 Flashcards | Quizlet
BCSCP Exam (updated 2025) Questions &
Answers | Latest Already Graded A+ UPDATE
2025|2026
Save
Terms in this set (157)
First published in Feb, official Aug 1. Second published
USP Supplements
in June, official Dec 1.
Biologics License Application (BLA)
Public Health Service Act
351(k) pathway for biosimilars
Enforcement of USP Responsibility of FDA and other govt authorities.
Standards USP has no role in enforcement
"About" Indicates a quantity within 10%
Compounder shall label with date of receipt and
USP 795 bulk product
assign a conservative expiration date not to exceed 3
expiration
yrs
795 BUD Nonaqueous Not later than the time remaining until the earliest
formulations expiration day of any API or 6 months
795 BUD Water Containing Not later than 14 days when stored at controlled cold
Oral Formulation temp
795 BUD Water Containing Not later than 30 days
Topical & Mucosal Liquids
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,10/1/25, 11:46 AM BCSCP Exam (updated 2025) Questions & Answers | Latest Already Graded A+ UPDATE 2025|2026 Flashcards | Quizlet
Records retained for the same period of time required
for any prescription under state law
Compounding
May be a copy of the prescription
Documentation
Should include Master Formulation Record and
Compounding Record
Limits are in particulates of 5 um and larger per cubic
meter
ISO Class of Particulates in
ISO 5 (class 100) 3,520
Room Air
ISO 7 (class 10,000) 352,000
ISO 8 (class 100,000) 3,520,000
Not more than 3 packages & not more than 2 entries
48 hr at room temp (20-25)
Low Risk CSP
14 days at cold temp (2-8)
45 days solid frozen state (-25 to -10)
Low Risk 12 hr BUD Non hazardous & radio pharmaceuticals
ISO 5 PEC
No unsealed windows or doors that connect to
Segregated compounding
outdoors or high traffic
area
Not adjacent to construction, warehouses, or food
prep
Annually
Simulates most challenging or stressful conditions
Completed without interruption
Media-Fill Testing
Soybean Casein Digest Medium (trypticase soy broth
or tyrpticase soy agar)
Incubated 20-25 or 30-35 for min 14 days
Multiple individual or small doses of sterile products
combined, more complex manipulation, with medium
Medium Risk CSP risk storage (30 hours at room temp, 9 days
refrigerated, 45 days frozen)
Ex: TPN, reservoirs
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, 10/1/25, 11:46 AM BCSCP Exam (updated 2025) Questions & Answers | Latest Already Graded A+ UPDATE 2025|2026 Flashcards | Quizlet
Non sterile ingredients
Exposed to air quality worse than ISO 5 for more than
1 hour
Improperly garbed personnel
High Risk CSP
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
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
Dry Heat 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
Used to render glassware it containers free of
pyrogens & viable microbes
Depyrogenation by dry 30 minutes at 250
heat Verified using endotoxin challenge vials (ECVs) to
verify cycle capable of achieving 3-log reduction in
endotoxin
All no sterile devices rinsed with sterile, pyrogens
free water then drained or dried immediately prior to
high risk compounding
High Risk CSP Prep
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
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BCSCP Exam (updated 2025) Questions &
Answers | Latest Already Graded A+ UPDATE
2025|2026
Save
Terms in this set (157)
First published in Feb, official Aug 1. Second published
USP Supplements
in June, official Dec 1.
Biologics License Application (BLA)
Public Health Service Act
351(k) pathway for biosimilars
Enforcement of USP Responsibility of FDA and other govt authorities.
Standards USP has no role in enforcement
"About" Indicates a quantity within 10%
Compounder shall label with date of receipt and
USP 795 bulk product
assign a conservative expiration date not to exceed 3
expiration
yrs
795 BUD Nonaqueous Not later than the time remaining until the earliest
formulations expiration day of any API or 6 months
795 BUD Water Containing Not later than 14 days when stored at controlled cold
Oral Formulation temp
795 BUD Water Containing Not later than 30 days
Topical & Mucosal Liquids
https://quizlet.com/1085605372/bcscp-exam-updated-2025-questions-answers-latest-already-graded-a-update-20252026-flash-cards/?new 1/24
,10/1/25, 11:46 AM BCSCP Exam (updated 2025) Questions & Answers | Latest Already Graded A+ UPDATE 2025|2026 Flashcards | Quizlet
Records retained for the same period of time required
for any prescription under state law
Compounding
May be a copy of the prescription
Documentation
Should include Master Formulation Record and
Compounding Record
Limits are in particulates of 5 um and larger per cubic
meter
ISO Class of Particulates in
ISO 5 (class 100) 3,520
Room Air
ISO 7 (class 10,000) 352,000
ISO 8 (class 100,000) 3,520,000
Not more than 3 packages & not more than 2 entries
48 hr at room temp (20-25)
Low Risk CSP
14 days at cold temp (2-8)
45 days solid frozen state (-25 to -10)
Low Risk 12 hr BUD Non hazardous & radio pharmaceuticals
ISO 5 PEC
No unsealed windows or doors that connect to
Segregated compounding
outdoors or high traffic
area
Not adjacent to construction, warehouses, or food
prep
Annually
Simulates most challenging or stressful conditions
Completed without interruption
Media-Fill Testing
Soybean Casein Digest Medium (trypticase soy broth
or tyrpticase soy agar)
Incubated 20-25 or 30-35 for min 14 days
Multiple individual or small doses of sterile products
combined, more complex manipulation, with medium
Medium Risk CSP risk storage (30 hours at room temp, 9 days
refrigerated, 45 days frozen)
Ex: TPN, reservoirs
https://quizlet.com/1085605372/bcscp-exam-updated-2025-questions-answers-latest-already-graded-a-update-20252026-flash-cards/?new 2/24
, 10/1/25, 11:46 AM BCSCP Exam (updated 2025) Questions & Answers | Latest Already Graded A+ UPDATE 2025|2026 Flashcards | Quizlet
Non sterile ingredients
Exposed to air quality worse than ISO 5 for more than
1 hour
Improperly garbed personnel
High Risk CSP
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
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
Dry Heat 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
Used to render glassware it containers free of
pyrogens & viable microbes
Depyrogenation by dry 30 minutes at 250
heat Verified using endotoxin challenge vials (ECVs) to
verify cycle capable of achieving 3-log reduction in
endotoxin
All no sterile devices rinsed with sterile, pyrogens
free water then drained or dried immediately prior to
high risk compounding
High Risk CSP Prep
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
https://quizlet.com/1085605372/bcscp-exam-updated-2025-questions-answers-latest-already-graded-a-update-20252026-flash-cards/?new 3/24
