9/25/25, 9:24 PM Pharmacy Law MPJE Exam: Federal Law
Pharmacy Law MPJE Exam: Federal Law Exam
NEWEST Version
2025 - 2026 COMPLETE QUESTIONS AND CORRECT
DETAILED ANSWERS (VERIFIED ANSWERS) |ALREADY
GRADED A+||BRAND NEW VERSION!!
Provided tax and exclusive licensing incentives for
What did the Orphan Drug Act manufacturers to develop agents for the treatment of
of 1983 do?
rare disease or conditions (those conditions that affect <
200,000 Americans)
Made generic drugs more readily available to the public
and at the same time provided incentives for
What did the Drug Price
manufacturers to develop new drugs
Competition and Patent
Term Restoration Act of
Eliminated the need for generic to prove safety and
1984 do?
efficacy thus allowing new generics to get approved
more easily
Established sales restrictions and recordkeeping
requirements for prescription drug samples
Prohibits hospitals and other healthcare entities from
selling drugs to other businesses (because the hospitals
were getting the drugs for a discount then reselling
them)
What did the Prescription
Drug Marketing Act of
Requires state licensing of wholesalers
1987 do?
Prohibits ANY SAMPLES for any reason in a retail pharmacy
Bans importation of prescription drugs except by
manufacturers and for emergency use
/ 1/34
,9/25/25, 9:24 PM Pharmacy Law MPJE Exam: Federal Law
Mandates record keeping requirements for drug samples for 3
years
Drug companies volunteered to pay tax and the money
What is the Prescription Drug
was used to hire more FDA scientist in hopes to speed
User Fee Act of 1992
up NDA reviews; however the price of drugs just went
up to cover the fee being paid by the drug
manufacturers
What did the Dietary Provided laws on the regulation of dietary supplements;
Supplement Health and forced the FDA to treat these products more as food
Education Act (DSHEA) of than drugs
1994 do?
A product that is intended for ORAL ingestion, intended
to supplement the diet, and contains any one or more
Define dietary supplement per of the following: a vitamin, mineral, herb or other
the law
botanical, an amino acid, dietary substance or use by
humans to supplement the diet by increasing the total
dietary intake and a concentrate, metabolite,
constituent, extract or combination of the previous.
A dietary supplement; they CANNOT say they are drugs or
All dietary supplements must
anything else on the
be claimed as
labeling
/ 2/34
,9/25/25, 9:24 PM Pharmacy Law MPJE Exam: Federal Law
Dietary supplement Disease Claims
manufacturers may not make
these claims
Structure / Function
Dietary supplement
manufacturers may only
The label can't say that it will cure or prevent but it can say "will
make these types of support or maintain"
claims
Dietary Supplements must "This statement has not been evaluated by the FDA. This
have this on the labeling product is not intended to diagnose, treat, cure or
prevent any disease."
Who enforces drug FDA
advertising?
Who enforces dietary FTC
supplement advertising
Do dietary supplements No
have to be safe and/or
effective?
The FDA cannot act until the dietary supplement is
How does a dietary proven to be dangerous; the products should not be
supplement get pulled off adulterated or misbranded (passed in 2007); however
the market? since little to no testing is conducted on these products
it would be difficult to tell if they are adulterated or
misbranded
No; here are the rules:
Can you put a bunch of Dietary supplement publications must be
publications regarding how
awesome a dietary reprinted in their ENTIRETY You cannot have
supplement is on the self with
the dietary supplement to get any information that is FALSE or
people to purchase the
product? MISLEADING
Must be present with other publications, if available, to present a
balanced view
All publications must be PHYSICALLY SEPARATE from the
/ 3/34
, 9/25/25, 9:24 PM Pharmacy Law MPJE Exam: Federal Law
product
1) Renewed the Prescription Drug User Fee Act
2) Compounding by pharmacists was finally clarified
3) Manufacturer only has to do 1 clinical trial to supplement their
What did the Food NDA
and Drug 4) Established inactive OTC ingredients requirement
Modernization Act of 5) Pharmacists can do nuclear compounding
1997 do? 6) Fast track approval process for drugs used for serious
or life-threatening diseases (initial drugs for this were
HIV/AIDS medications)
What organization is the FDA
primary enforcer of the
FDCA?
The FDA is a component of DHHS
what organization?
Is the USP a government No, it is an independent agency that sets purity standards
agency?
A drug recognized in the Misbranded or adulterated
USP/NF must meet all
standards or it will be
considered
What are the 2 major 1) Adulteration
offenses of the FDCA? 2) Misbranding
These violations are of Adulteration or misbranding results in violation of the
"strict liability nature", FDCA regardless of the person's knowledge or
what does that mean? intentions
Most serious; issued when there is reasonable
Describe a Class I Recall
probability that the product will cause serious, adverse
health consequences or death; must contact patients
Describe a Class II Recall May result in temporary or medically reversible adverse effects;
probability is remote
Describe a Class III Recall Not going to hurt anyone; usually technical violations
/ 4/34
Pharmacy Law MPJE Exam: Federal Law Exam
NEWEST Version
2025 - 2026 COMPLETE QUESTIONS AND CORRECT
DETAILED ANSWERS (VERIFIED ANSWERS) |ALREADY
GRADED A+||BRAND NEW VERSION!!
Provided tax and exclusive licensing incentives for
What did the Orphan Drug Act manufacturers to develop agents for the treatment of
of 1983 do?
rare disease or conditions (those conditions that affect <
200,000 Americans)
Made generic drugs more readily available to the public
and at the same time provided incentives for
What did the Drug Price
manufacturers to develop new drugs
Competition and Patent
Term Restoration Act of
Eliminated the need for generic to prove safety and
1984 do?
efficacy thus allowing new generics to get approved
more easily
Established sales restrictions and recordkeeping
requirements for prescription drug samples
Prohibits hospitals and other healthcare entities from
selling drugs to other businesses (because the hospitals
were getting the drugs for a discount then reselling
them)
What did the Prescription
Drug Marketing Act of
Requires state licensing of wholesalers
1987 do?
Prohibits ANY SAMPLES for any reason in a retail pharmacy
Bans importation of prescription drugs except by
manufacturers and for emergency use
/ 1/34
,9/25/25, 9:24 PM Pharmacy Law MPJE Exam: Federal Law
Mandates record keeping requirements for drug samples for 3
years
Drug companies volunteered to pay tax and the money
What is the Prescription Drug
was used to hire more FDA scientist in hopes to speed
User Fee Act of 1992
up NDA reviews; however the price of drugs just went
up to cover the fee being paid by the drug
manufacturers
What did the Dietary Provided laws on the regulation of dietary supplements;
Supplement Health and forced the FDA to treat these products more as food
Education Act (DSHEA) of than drugs
1994 do?
A product that is intended for ORAL ingestion, intended
to supplement the diet, and contains any one or more
Define dietary supplement per of the following: a vitamin, mineral, herb or other
the law
botanical, an amino acid, dietary substance or use by
humans to supplement the diet by increasing the total
dietary intake and a concentrate, metabolite,
constituent, extract or combination of the previous.
A dietary supplement; they CANNOT say they are drugs or
All dietary supplements must
anything else on the
be claimed as
labeling
/ 2/34
,9/25/25, 9:24 PM Pharmacy Law MPJE Exam: Federal Law
Dietary supplement Disease Claims
manufacturers may not make
these claims
Structure / Function
Dietary supplement
manufacturers may only
The label can't say that it will cure or prevent but it can say "will
make these types of support or maintain"
claims
Dietary Supplements must "This statement has not been evaluated by the FDA. This
have this on the labeling product is not intended to diagnose, treat, cure or
prevent any disease."
Who enforces drug FDA
advertising?
Who enforces dietary FTC
supplement advertising
Do dietary supplements No
have to be safe and/or
effective?
The FDA cannot act until the dietary supplement is
How does a dietary proven to be dangerous; the products should not be
supplement get pulled off adulterated or misbranded (passed in 2007); however
the market? since little to no testing is conducted on these products
it would be difficult to tell if they are adulterated or
misbranded
No; here are the rules:
Can you put a bunch of Dietary supplement publications must be
publications regarding how
awesome a dietary reprinted in their ENTIRETY You cannot have
supplement is on the self with
the dietary supplement to get any information that is FALSE or
people to purchase the
product? MISLEADING
Must be present with other publications, if available, to present a
balanced view
All publications must be PHYSICALLY SEPARATE from the
/ 3/34
, 9/25/25, 9:24 PM Pharmacy Law MPJE Exam: Federal Law
product
1) Renewed the Prescription Drug User Fee Act
2) Compounding by pharmacists was finally clarified
3) Manufacturer only has to do 1 clinical trial to supplement their
What did the Food NDA
and Drug 4) Established inactive OTC ingredients requirement
Modernization Act of 5) Pharmacists can do nuclear compounding
1997 do? 6) Fast track approval process for drugs used for serious
or life-threatening diseases (initial drugs for this were
HIV/AIDS medications)
What organization is the FDA
primary enforcer of the
FDCA?
The FDA is a component of DHHS
what organization?
Is the USP a government No, it is an independent agency that sets purity standards
agency?
A drug recognized in the Misbranded or adulterated
USP/NF must meet all
standards or it will be
considered
What are the 2 major 1) Adulteration
offenses of the FDCA? 2) Misbranding
These violations are of Adulteration or misbranding results in violation of the
"strict liability nature", FDCA regardless of the person's knowledge or
what does that mean? intentions
Most serious; issued when there is reasonable
Describe a Class I Recall
probability that the product will cause serious, adverse
health consequences or death; must contact patients
Describe a Class II Recall May result in temporary or medically reversible adverse effects;
probability is remote
Describe a Class III Recall Not going to hurt anyone; usually technical violations
/ 4/34
