BCSCP Exam Questions and
Answers 100% Pass
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
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
COPYRIGHT 2025 ALL RIGHTS RESERVED, TRUSTED AND VERIFIED 1
,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
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
COPYRIGHT 2025 ALL RIGHTS RESERVED, TRUSTED AND VERIFIED 2
,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
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
COPYRIGHT 2025 ALL RIGHTS RESERVED, TRUSTED AND VERIFIED 3
, 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 - 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 - 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 - ANSWER-Nonsterile bulk drugs that will be terminally
sterilized
Exposing sterile ingredients to worse than ISO 5 air for more than 1 hour
COPYRIGHT 2025 ALL RIGHTS RESERVED, TRUSTED AND VERIFIED 4
Answers 100% Pass
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
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
COPYRIGHT 2025 ALL RIGHTS RESERVED, TRUSTED AND VERIFIED 1
,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
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
COPYRIGHT 2025 ALL RIGHTS RESERVED, TRUSTED AND VERIFIED 2
,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
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
COPYRIGHT 2025 ALL RIGHTS RESERVED, TRUSTED AND VERIFIED 3
, 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 - 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 - 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 - ANSWER-Nonsterile bulk drugs that will be terminally
sterilized
Exposing sterile ingredients to worse than ISO 5 air for more than 1 hour
COPYRIGHT 2025 ALL RIGHTS RESERVED, TRUSTED AND VERIFIED 4
