BCSCP EXAM 2025/2026 QUESTIONS
AND ANSWERS 100% PASS
USP Supplements - ANS First published in Feb, official Aug 1. Second published in June,
official Dec 1.
Public Health Service Act - ANS Biologics License Application (BLA)
351(k) pathway for biosimilars
Enforcement of USP Standards - ANS Responsibility of FDA and other govt authorities.
USP has no role in enforcement
"About" - ANS Indicates a quantity within 10%
USP 795 bulk product expiration - ANS Compounder shall label with date of receipt and
assign a conservative expiration date not to exceed 3 yrs
795 BUD Nonaqueous formulations - ANS Not later than the time remaining until the earliest
expiration day of any API or 6 months
795 BUD Water Containing Oral Formulation - ANS Not later than 14 days when stored at
controlled cold temp
pg. 1 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED
,795 BUD Water Containing Topical & Mucosal Liquids - ANS Not later than 30 days
Compounding Documentation - ANS 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 - ANS 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 - ANS 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 - ANS Non hazardous & radio pharmaceuticals
Segregated compounding area - ANS 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 - ANS Annually
Simulates most challenging or stressful conditions
pg. 2 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED
, 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 - ANS 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 - ANS 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 - ANS 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 - ANS 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
pg. 3 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED
AND ANSWERS 100% PASS
USP Supplements - ANS First published in Feb, official Aug 1. Second published in June,
official Dec 1.
Public Health Service Act - ANS Biologics License Application (BLA)
351(k) pathway for biosimilars
Enforcement of USP Standards - ANS Responsibility of FDA and other govt authorities.
USP has no role in enforcement
"About" - ANS Indicates a quantity within 10%
USP 795 bulk product expiration - ANS Compounder shall label with date of receipt and
assign a conservative expiration date not to exceed 3 yrs
795 BUD Nonaqueous formulations - ANS Not later than the time remaining until the earliest
expiration day of any API or 6 months
795 BUD Water Containing Oral Formulation - ANS Not later than 14 days when stored at
controlled cold temp
pg. 1 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED
,795 BUD Water Containing Topical & Mucosal Liquids - ANS Not later than 30 days
Compounding Documentation - ANS 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 - ANS 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 - ANS 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 - ANS Non hazardous & radio pharmaceuticals
Segregated compounding area - ANS 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 - ANS Annually
Simulates most challenging or stressful conditions
pg. 2 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED
, 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 - ANS 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 - ANS 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 - ANS 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 - ANS 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
pg. 3 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED
