1:
BCSCP Exam Questions & Correct Answers |
Newest Updated 2026/2027 | Graded A+.
USP Supplements ANSWER>>>>First published in Feb, official Aug 1. Second published
in June, official Dec 1.
Public Health Service Act ANSWER>>>>Biologics License Application (BLA)
351(k) pathway for biosimilars
Enforcement of USP Standards ANSWER>>>>Responsibility of FDA and other govt
authorities.
USP has no role in enforcement
USP 795 bulk product expiration ANSWER>>>>Compounder shall label with date of
receipt and assign a conservative expiration date not to exceed 3 yrs
, 2:
795 BUD Nonaqueous formulations ANSWER>>>>Not later than the time remaining
until the earliest expiration day of any API or 6 months
795 BUD Water Containing Oral Formulation ANSWER>>>>Not later than 14 days when
stored at controlled cold temp
795 BUD Water Containing Topical & Mucosal Liquids ANSWER>>>>Not later than 30
days
Compounding Documentation 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
"About" ANSWER>>>>Indicates a quantity within 10%
ISO Class of Particulates in Room Air 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
, 3:
Low Risk CSP 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 ANSWER>>>>Non hazardous & radio pharmaceuticals
Media-Fill Testing 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 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 ANSWER>>>>Non sterile ingredients
Exposed to air quality worse than ISO 5 for more than 1 hour
Improperly garbed personnel
, 4:
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
Segregated compounding area ANSWER>>>>ISO 5 PEC
No unsealed windows or doors that connect to outdoors or high traffic
Not adjacent to construction, warehouses, or food prep
Dry Heat Sterilization 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 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
BCSCP Exam Questions & Correct Answers |
Newest Updated 2026/2027 | Graded A+.
USP Supplements ANSWER>>>>First published in Feb, official Aug 1. Second published
in June, official Dec 1.
Public Health Service Act ANSWER>>>>Biologics License Application (BLA)
351(k) pathway for biosimilars
Enforcement of USP Standards ANSWER>>>>Responsibility of FDA and other govt
authorities.
USP has no role in enforcement
USP 795 bulk product expiration ANSWER>>>>Compounder shall label with date of
receipt and assign a conservative expiration date not to exceed 3 yrs
, 2:
795 BUD Nonaqueous formulations ANSWER>>>>Not later than the time remaining
until the earliest expiration day of any API or 6 months
795 BUD Water Containing Oral Formulation ANSWER>>>>Not later than 14 days when
stored at controlled cold temp
795 BUD Water Containing Topical & Mucosal Liquids ANSWER>>>>Not later than 30
days
Compounding Documentation 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
"About" ANSWER>>>>Indicates a quantity within 10%
ISO Class of Particulates in Room Air 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
, 3:
Low Risk CSP 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 ANSWER>>>>Non hazardous & radio pharmaceuticals
Media-Fill Testing 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 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 ANSWER>>>>Non sterile ingredients
Exposed to air quality worse than ISO 5 for more than 1 hour
Improperly garbed personnel
, 4:
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
Segregated compounding area ANSWER>>>>ISO 5 PEC
No unsealed windows or doors that connect to outdoors or high traffic
Not adjacent to construction, warehouses, or food prep
Dry Heat Sterilization 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 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
