BCSCP Exam 150 Questions and Verified 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
SDV & MDV BUD - Correct Answer SDV within 1 hour if opened in worse than ISO 5 air
SDV up to 6 hours punctured in ISO 5
Ampules may not be stored for any time period
MDV 28 days
HD handling - Correct Answer Stored in negative pressure with at least 12 ACPH
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
SDV & MDV BUD - Correct Answer SDV within 1 hour if opened in worse than ISO 5 air
SDV up to 6 hours punctured in ISO 5
Ampules may not be stored for any time period
MDV 28 days
HD handling - Correct Answer Stored in negative pressure with at least 12 ACPH
