BCSCP EXAM LATEST
USP Supplements - ANSWERS-First published in Feb, official Aug 1.
Second published in June, official Dec 1.
Public Health Service Act - ANSWERS-Biologics License Application
(BLA)
351(k) pathway for biosimilars
Enforcement of USP Standards - ANSWERS-Responsibility of FDA
and other govt authorities.
USP has no role in enforcement
"About" - ANSWERS-Indicates a quantity within 10%
USP 795 bulk product expiration - ANSWERS-Compounder shall label
with date of receipt and assign a conservative expiration date not to
exceed 3 yrs
795 BUD Nonaqueous formulations - ANSWERS-Not later than the
time remaining until the earliest expiration day of any API or 6 months
END OF
PAGE
1
, BCSCP EXAM LATEST
795 BUD Water Containing Oral Formulation - ANSWERS-Not later
than 14 days when stored at controlled cold temp
795 BUD Water Containing Topical & Mucosal Liquids - ANSWERS-
Not later than 30 days
Compounding Documentation - ANSWERS-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 - ANSWERS-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 - ANSWERS-Not more than 3 packages & not more than
2 entries
48 hr at room temp (20-25)
14 days at cold temp (2-8)
END OF
PAGE
2
, BCSCP EXAM LATEST
45 days solid frozen state (-25 to -10)
Low Risk 12 hr BUD - ANSWERS-Non hazardous & radio
pharmaceuticals
Segregated compounding area - ANSWERS-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 - ANSWERS-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 - ANSWERS-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
END OF
PAGE
3
, BCSCP EXAM LATEST
High Risk CSP - ANSWERS-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 - ANSWERS-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 - ANSWERS-Used to render glassware it
containers free of pyrogens & viable microbes
30 minutes at 250
END OF
PAGE
4
USP Supplements - ANSWERS-First published in Feb, official Aug 1.
Second published in June, official Dec 1.
Public Health Service Act - ANSWERS-Biologics License Application
(BLA)
351(k) pathway for biosimilars
Enforcement of USP Standards - ANSWERS-Responsibility of FDA
and other govt authorities.
USP has no role in enforcement
"About" - ANSWERS-Indicates a quantity within 10%
USP 795 bulk product expiration - ANSWERS-Compounder shall label
with date of receipt and assign a conservative expiration date not to
exceed 3 yrs
795 BUD Nonaqueous formulations - ANSWERS-Not later than the
time remaining until the earliest expiration day of any API or 6 months
END OF
PAGE
1
, BCSCP EXAM LATEST
795 BUD Water Containing Oral Formulation - ANSWERS-Not later
than 14 days when stored at controlled cold temp
795 BUD Water Containing Topical & Mucosal Liquids - ANSWERS-
Not later than 30 days
Compounding Documentation - ANSWERS-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 - ANSWERS-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 - ANSWERS-Not more than 3 packages & not more than
2 entries
48 hr at room temp (20-25)
14 days at cold temp (2-8)
END OF
PAGE
2
, BCSCP EXAM LATEST
45 days solid frozen state (-25 to -10)
Low Risk 12 hr BUD - ANSWERS-Non hazardous & radio
pharmaceuticals
Segregated compounding area - ANSWERS-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 - ANSWERS-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 - ANSWERS-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
END OF
PAGE
3
, BCSCP EXAM LATEST
High Risk CSP - ANSWERS-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 - ANSWERS-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 - ANSWERS-Used to render glassware it
containers free of pyrogens & viable microbes
30 minutes at 250
END OF
PAGE
4
