PHARMACY LAW: THE MULTISTATE
PHARMACY JURISPRUDENCE
EXAMINATION (MPJE) EXAM FEDERAL
LAW | STUDY GUIDE, PRACTICE
QUESTIONS AND DETAILED ANSWERS |
GRADED A+ | GUARANTEED SUCCESS
Updated 2026 Questions and Answers | 100% Verified
Exam Prep
,What did the Pure Food and Drug Act of 1906 do? Prohibited the adulteration and misbranding of foods and drugs in interstate commerce;
DID NOT have to be proven safe or effective; did not require the label to list ingredients,
directions for use, or provide warnings
What did the Food, Drug, and Cosmetic Act do? (started in Provides for the comprehensive regulation of all drugs introduced into interstate (and
1938) most intrastate) commerce
Under this act no new drug may be marketed and sold unless it has been proved SAFE
ONLY for its intended use and approved by the FDA
Labels must contain adequate directions for use and warnings about habit-forming
properties of certain drugs
Describe the FDCA The purpose of the FDCA is to protect consumers from adulterated or misbranded foods,
drugs, cosmetics, or devices; provided that no new drug could be marketed until proven
safe for use under the conditions described on the label and approved by the FDA; also
started the labeling requirements; applies to devices as well; all drugs before 1938 are
exempt from the requirement that new drugs be proven safe
If you get in trouble with the board of pharmacy can you get Yes, you can have an administrative lawsuit, a civil lawsuit, and a criminal lawsuit
in trouble with the government too? What about the a lawsuit separately for the same offense
with a patient?
What did the Durham-Humphrey Amendment of 1951 do? Established 2 classes of drugs; prescription and OTC
Allows refills on prescriptions and oral prescriptions
Per the Durham-Humphrey Amendment; what must be labeled Caution: federal law prohibits dispensing without a Rx; they do not need adequate
on a prescription medication directions for use like OTC (talking about the MANUFACTURERS label here; there is no
take this medication x amount of times daily on the manufacturer labeling)
What did the Kefauver-Harris Amendment of 1962 do? Required all drugs to not only be proven safe but also EFFECTIVE
Transferred the regulation of drug advertising from the FTC to the FDA
The efficacy requirement made by the Kefauver-Harris 1938-1962; drugs produced before 1938 were just grandfathered in and did not have to
Amendment included all drugs marketed during what time prove their efficacy
period
, What did the Orphan Drug Act of 1983 do? Provided tax and exclusive licensing incentives for manufacturers to develop agents for
the treatment of rare disease or conditions (those conditions that affect < 200,000
Americans)
What did the Drug Price Competition and Patent Term Made generic drugs more readily available to the public and at the same time provided
Restoration Act of 1984 do? incentives for manufacturers to develop new drugs
Eliminated the need for generic to prove safety and efficacy thus allowing new generics
to get approved more easily
What did the Prescription Drug Marketing Act of 1987 do? 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)
Requires state licensing of wholesalers
Prohibits ANY SAMPLES for any reason in a retail pharmacy
Bans importation of prescription drugs except by manufacturers and for emergency use
Mandates record keeping requirements for drug samples for 3 years
What is the Prescription Drug User Fee Act of 1992 Drug companies volunteered to pay tax and the money was used to hire more FDA
scientist in hopes to speed 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 Supplement Health and Education Act Provided laws on the regulation of dietary supplements; forced the FDA to treat these
(DSHEA) of 1994 do? products more as food than drugs
Define dietary supplement per the law A product that is intended for ORAL ingestion, intended to supplement the diet, and
contains any one or more of the following: a vitamin, mineral, herb or other 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.
All dietary supplements must be claimed as A dietary supplement; they CANNOT say they are drugs or anything else on the labeling
PHARMACY JURISPRUDENCE
EXAMINATION (MPJE) EXAM FEDERAL
LAW | STUDY GUIDE, PRACTICE
QUESTIONS AND DETAILED ANSWERS |
GRADED A+ | GUARANTEED SUCCESS
Updated 2026 Questions and Answers | 100% Verified
Exam Prep
,What did the Pure Food and Drug Act of 1906 do? Prohibited the adulteration and misbranding of foods and drugs in interstate commerce;
DID NOT have to be proven safe or effective; did not require the label to list ingredients,
directions for use, or provide warnings
What did the Food, Drug, and Cosmetic Act do? (started in Provides for the comprehensive regulation of all drugs introduced into interstate (and
1938) most intrastate) commerce
Under this act no new drug may be marketed and sold unless it has been proved SAFE
ONLY for its intended use and approved by the FDA
Labels must contain adequate directions for use and warnings about habit-forming
properties of certain drugs
Describe the FDCA The purpose of the FDCA is to protect consumers from adulterated or misbranded foods,
drugs, cosmetics, or devices; provided that no new drug could be marketed until proven
safe for use under the conditions described on the label and approved by the FDA; also
started the labeling requirements; applies to devices as well; all drugs before 1938 are
exempt from the requirement that new drugs be proven safe
If you get in trouble with the board of pharmacy can you get Yes, you can have an administrative lawsuit, a civil lawsuit, and a criminal lawsuit
in trouble with the government too? What about the a lawsuit separately for the same offense
with a patient?
What did the Durham-Humphrey Amendment of 1951 do? Established 2 classes of drugs; prescription and OTC
Allows refills on prescriptions and oral prescriptions
Per the Durham-Humphrey Amendment; what must be labeled Caution: federal law prohibits dispensing without a Rx; they do not need adequate
on a prescription medication directions for use like OTC (talking about the MANUFACTURERS label here; there is no
take this medication x amount of times daily on the manufacturer labeling)
What did the Kefauver-Harris Amendment of 1962 do? Required all drugs to not only be proven safe but also EFFECTIVE
Transferred the regulation of drug advertising from the FTC to the FDA
The efficacy requirement made by the Kefauver-Harris 1938-1962; drugs produced before 1938 were just grandfathered in and did not have to
Amendment included all drugs marketed during what time prove their efficacy
period
, What did the Orphan Drug Act of 1983 do? Provided tax and exclusive licensing incentives for manufacturers to develop agents for
the treatment of rare disease or conditions (those conditions that affect < 200,000
Americans)
What did the Drug Price Competition and Patent Term Made generic drugs more readily available to the public and at the same time provided
Restoration Act of 1984 do? incentives for manufacturers to develop new drugs
Eliminated the need for generic to prove safety and efficacy thus allowing new generics
to get approved more easily
What did the Prescription Drug Marketing Act of 1987 do? 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)
Requires state licensing of wholesalers
Prohibits ANY SAMPLES for any reason in a retail pharmacy
Bans importation of prescription drugs except by manufacturers and for emergency use
Mandates record keeping requirements for drug samples for 3 years
What is the Prescription Drug User Fee Act of 1992 Drug companies volunteered to pay tax and the money was used to hire more FDA
scientist in hopes to speed 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 Supplement Health and Education Act Provided laws on the regulation of dietary supplements; forced the FDA to treat these
(DSHEA) of 1994 do? products more as food than drugs
Define dietary supplement per the law A product that is intended for ORAL ingestion, intended to supplement the diet, and
contains any one or more of the following: a vitamin, mineral, herb or other 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.
All dietary supplements must be claimed as A dietary supplement; they CANNOT say they are drugs or anything else on the labeling
