FEDERAL LAW MULTISTATE PHARMACY
JURISPRUDENCE EXAMINATION (MPJE)
| EXAM PREP, STUDY GUIDE AND
PRACTICE QUESTIONS | GRADED A+ |
GUARANTEED SUCCESS
Updated 2026 Questions and Answers | 100% Verified
Exam Prep
,Types of compounding nonsterile or sterile
can be divided into non hazardous or hazardous
503A traditional compounding 503A facilities perform tradititional compounding based on pt specific prescriptions
Compounding for bulk medical office use is prohibited
503B outsourcing facilities allows compounding pharmacies to make sterile products for humans to register with the
FDA as an outsourcing facility
Can prepare medications in bulk w/o prescription written for an individual pt
Can compound for office use
More stringent guidelines due to impact on pt populaitons
must follow USP and CGMPs products
These include increased product testing
Who can compound? Physicians and other HC practitioners are permitted to compound in medical offices
Compounding ingredients Active ingredient and excipients must be high quality
ingredients that are acceptable for use are listed in USP-National formulary or Food
Chemicals Codex (FCC)
Ingredients should be manufacturered at FDA registered facility
If ingredient comes from non FDA facility a Certificate of Analysis should be obtained to
confirm quality
If there is a component w/o an expiration date the pharmacist will assign 3 years
label should contain both date of recipt and assigned expiration date
,Non sterile compounding Primarily used to prepare a dose or fomrulation that's not commercially available such as
-changing solid tab to a liquid
-compounding 10% from 15 and 5%
Can be done to avoid excipient or add falvor
Routes: Mouth, tube, rectum
Physical space requirements of nonsterile compoundings Can be done in room air but must separated from dispensing part
All components and containers must be stored off the floor
BUD for non sterile preparations Packed in tight, light resistant containers
USP specifies refrigeration for water compounding oral formulations
Some exceptions to BUD recommendations
-if ingredient expires before BUD use earliest
-BUDs can be extended if stability data
How to determine BUD Non sterile formulation
-Doesn't contain water --> store room temp, 6 months
-contains water -->PO formulation, stored in fridge, BUD 14 days
-Non oral containing water (lotion, cream, etc.)--> room temp, BUD 30 days
Sterile compounding IV, IM, SQ injections, eyedrops, pulmonary inhalations
Air Quality ISO sets standards for air quality
lower particle count = lower ISO = cleaner air
Critical areas that are closest to exposed sterile drugs (inside sterile hood) must be at
least ISO 5
, Primary Engineering Control PEC
Provides ISO5 environment
-most common way to achieve is by using sterile hood (LAFW) to make CSPs
Compounding Aseptic Isolater (CAI) is another PEC thats located in segregated area
(SCA)
-referred to glovebox
Secondary Engineering Control SEC
Commonly called buffer area and must be ISO 7
Anteroom Garbing and handwashing take place here and must be ISO 8 if opens to positive
pressure or ISO 7 if opens to negative pressure
Positive Air pressure For non HD drugs the air pressure inside PEC and SEC are both positive
Sterile Preparation and Risk CSPs are categorized by risk of contamination
Each time IV bag is entered to remove or add a drug the risk of contamination increases
risks are low, medium, and high
Risk levels are used to determine to appropriate BUD
Higher risk level shorter BUD
Low and medium risk CSPs are prepared by pharmacy staff using sterile ingredients (PEC
contained w/in an SEC)
High risk sterile compounding uses non sterile ingredients and is not common
High risk CSPs must be sterilized prior to use
JURISPRUDENCE EXAMINATION (MPJE)
| EXAM PREP, STUDY GUIDE AND
PRACTICE QUESTIONS | GRADED A+ |
GUARANTEED SUCCESS
Updated 2026 Questions and Answers | 100% Verified
Exam Prep
,Types of compounding nonsterile or sterile
can be divided into non hazardous or hazardous
503A traditional compounding 503A facilities perform tradititional compounding based on pt specific prescriptions
Compounding for bulk medical office use is prohibited
503B outsourcing facilities allows compounding pharmacies to make sterile products for humans to register with the
FDA as an outsourcing facility
Can prepare medications in bulk w/o prescription written for an individual pt
Can compound for office use
More stringent guidelines due to impact on pt populaitons
must follow USP and CGMPs products
These include increased product testing
Who can compound? Physicians and other HC practitioners are permitted to compound in medical offices
Compounding ingredients Active ingredient and excipients must be high quality
ingredients that are acceptable for use are listed in USP-National formulary or Food
Chemicals Codex (FCC)
Ingredients should be manufacturered at FDA registered facility
If ingredient comes from non FDA facility a Certificate of Analysis should be obtained to
confirm quality
If there is a component w/o an expiration date the pharmacist will assign 3 years
label should contain both date of recipt and assigned expiration date
,Non sterile compounding Primarily used to prepare a dose or fomrulation that's not commercially available such as
-changing solid tab to a liquid
-compounding 10% from 15 and 5%
Can be done to avoid excipient or add falvor
Routes: Mouth, tube, rectum
Physical space requirements of nonsterile compoundings Can be done in room air but must separated from dispensing part
All components and containers must be stored off the floor
BUD for non sterile preparations Packed in tight, light resistant containers
USP specifies refrigeration for water compounding oral formulations
Some exceptions to BUD recommendations
-if ingredient expires before BUD use earliest
-BUDs can be extended if stability data
How to determine BUD Non sterile formulation
-Doesn't contain water --> store room temp, 6 months
-contains water -->PO formulation, stored in fridge, BUD 14 days
-Non oral containing water (lotion, cream, etc.)--> room temp, BUD 30 days
Sterile compounding IV, IM, SQ injections, eyedrops, pulmonary inhalations
Air Quality ISO sets standards for air quality
lower particle count = lower ISO = cleaner air
Critical areas that are closest to exposed sterile drugs (inside sterile hood) must be at
least ISO 5
, Primary Engineering Control PEC
Provides ISO5 environment
-most common way to achieve is by using sterile hood (LAFW) to make CSPs
Compounding Aseptic Isolater (CAI) is another PEC thats located in segregated area
(SCA)
-referred to glovebox
Secondary Engineering Control SEC
Commonly called buffer area and must be ISO 7
Anteroom Garbing and handwashing take place here and must be ISO 8 if opens to positive
pressure or ISO 7 if opens to negative pressure
Positive Air pressure For non HD drugs the air pressure inside PEC and SEC are both positive
Sterile Preparation and Risk CSPs are categorized by risk of contamination
Each time IV bag is entered to remove or add a drug the risk of contamination increases
risks are low, medium, and high
Risk levels are used to determine to appropriate BUD
Higher risk level shorter BUD
Low and medium risk CSPs are prepared by pharmacy staff using sterile ingredients (PEC
contained w/in an SEC)
High risk sterile compounding uses non sterile ingredients and is not common
High risk CSPs must be sterilized prior to use
