1|Page
BCSCP EXAM QUESTIONS AND ANSWERS 2025
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
"About" - .....ANSWER... ✔✔ Indicates a quantity
within 10%
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|Page
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
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|Page
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
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
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
, 4|Page
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
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 - .....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
BCSCP EXAM QUESTIONS AND ANSWERS 2025
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
"About" - .....ANSWER... ✔✔ Indicates a quantity
within 10%
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|Page
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
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|Page
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
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
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
, 4|Page
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
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 - .....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
