BCSCP Exam Questions With Correct
Answers
USP Supplements - CORRECT ANSWER✔✔-First published in Feb, official Aug 1.
| | | | | | | | | | |
Second published in June, official Dec 1.
| | | | | |
Public Health Service Act - CORRECT ANSWER✔✔-Biologics License Application
| | | | | | | | |
(BLA)
351(k) pathway for biosimilars
| | |
Enforcement of USP Standards - CORRECT ANSWER✔✔-Responsibility of FDA and
| | | | | | | | |
other govt authorities.
| | | |
USP has no role in enforcement
| | | | |
"About" - CORRECT ANSWER✔✔-Indicates a quantity within 10%
| | | | | | |
USP 795 bulk product expiration - CORRECT ANSWER✔✔-Compounder shall label
| | | | | | | | | |
with date of receipt and assign a conservative expiration date not to exceed 3 yrs
| | | | | | | | | | | | | |
795 BUD Nonaqueous formulations - CORRECT ANSWER✔✔-Not later than the
| | | | | | | | | |
time remaining until the earliest expiration day of any API or 6 months
| | | | | | | | | | | |
795 BUD Water Containing Oral Formulation - CORRECT ANSWER✔✔-Not later
| | | | | | | | | |
than 14 days when stored at controlled cold temp
| | | | | | | |
,795 BUD Water Containing Topical & Mucosal Liquids - CORRECT ANSWER✔✔-
| | | | | | | | | |
Not later than 30 days
| | | |
Compounding Documentation - CORRECT 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 - CORRECT 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 - CORRECT 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 - CORRECT ANSWER✔✔-Non hazardous & radio
| | | | | | | | | | |
pharmaceuticals
Segregated compounding area - CORRECT 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 - CORRECT 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 - CORRECT 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 - CORRECT 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 - CORRECT 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 - CORRECT 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 - CORRECT 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 | | | | | |
High Risk Conditions - CORRECT ANSWER✔✔-Nonsterile bulk drugs that will be
| | | | | | | | | | |
terminally sterilized |
Exposing sterile ingredients to worse than ISO 5 air for more than 1 hour
| | | | | | | | | | | | |
Mixing sterile ingredients in nonsterile devices
| | | | |
Assuming without evidence that bulk ingredients contain at least 95% of active
| | | | | | | | | | | |
chemical & have not been contaminated or adulterated between uses
| | | | | | | | |
Answers
USP Supplements - CORRECT ANSWER✔✔-First published in Feb, official Aug 1.
| | | | | | | | | | |
Second published in June, official Dec 1.
| | | | | |
Public Health Service Act - CORRECT ANSWER✔✔-Biologics License Application
| | | | | | | | |
(BLA)
351(k) pathway for biosimilars
| | |
Enforcement of USP Standards - CORRECT ANSWER✔✔-Responsibility of FDA and
| | | | | | | | |
other govt authorities.
| | | |
USP has no role in enforcement
| | | | |
"About" - CORRECT ANSWER✔✔-Indicates a quantity within 10%
| | | | | | |
USP 795 bulk product expiration - CORRECT ANSWER✔✔-Compounder shall label
| | | | | | | | | |
with date of receipt and assign a conservative expiration date not to exceed 3 yrs
| | | | | | | | | | | | | |
795 BUD Nonaqueous formulations - CORRECT ANSWER✔✔-Not later than the
| | | | | | | | | |
time remaining until the earliest expiration day of any API or 6 months
| | | | | | | | | | | |
795 BUD Water Containing Oral Formulation - CORRECT ANSWER✔✔-Not later
| | | | | | | | | |
than 14 days when stored at controlled cold temp
| | | | | | | |
,795 BUD Water Containing Topical & Mucosal Liquids - CORRECT ANSWER✔✔-
| | | | | | | | | |
Not later than 30 days
| | | |
Compounding Documentation - CORRECT 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 - CORRECT 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 - CORRECT 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 - CORRECT ANSWER✔✔-Non hazardous & radio
| | | | | | | | | | |
pharmaceuticals
Segregated compounding area - CORRECT 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 - CORRECT 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 - CORRECT 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 - CORRECT 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 - CORRECT 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 - CORRECT 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 - CORRECT 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 | | | | | |
High Risk Conditions - CORRECT ANSWER✔✔-Nonsterile bulk drugs that will be
| | | | | | | | | | |
terminally sterilized |
Exposing sterile ingredients to worse than ISO 5 air for more than 1 hour
| | | | | | | | | | | | |
Mixing sterile ingredients in nonsterile devices
| | | | |
Assuming without evidence that bulk ingredients contain at least 95% of active
| | | | | | | | | | | |
chemical & have not been contaminated or adulterated between uses
| | | | | | | | |
