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
, 2:
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
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
, 3:
USP 795 bulk product expiration ANSWER>>>>Compounder shall label with date of
receipt and assign a conservative expiration date not to exceed 3 yrs
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
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
, 4:
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
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
High Risk CSP Prep 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
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
, 2:
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
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
, 3:
USP 795 bulk product expiration ANSWER>>>>Compounder shall label with date of
receipt and assign a conservative expiration date not to exceed 3 yrs
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
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
, 4:
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
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
High Risk CSP Prep 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
